Study group: abstinent patients (at least 18 years old) with a diagnosed alcohol dependence after completed inpatient withdrawal treatment in the the last 3 months.

Primary hypothesis: the experience of presence during a virtual presentation of alcohol in alcohol-dependent patients is associated with levels of craving for alcohol during VR-CET. conditions: Alcohol Dependence studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: VR Cue-Exposure Therapy measure: Craving measure: Craving measure: Craving measure: Relapse rates measure: Quality of Life measure: Motion Sickness measure: Presence in VR sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Psychiatric University Hospital Charité at St. Hedwig Hospital city: Berlin zip: 10115 country: Germany lat: 52.52437 lon: 13.41053 hasResults: False

 nctId: NCT06333444 id: n. 08, 09/03/2021 briefTitle: Counselling Intervention for College Students Experienced Psychological Distress acronym: TRESPASS overallStatus: RECRUITING date: 2022-01-01 date: 2024-12-31 date: 2025-12-31 date: 2024-03-27 date: 2024-03-27 name: University of Campania "Luigi Vanvitelli" class: OTHER briefSummary: The goal of this clinical trial is to evaluate mental health and academic motivation in university students asking help to university counselling service (UCS) in Southern Italy before anf after four weekly psychological sessions.

The main question it aims to answer are:

* is the psychological counselling intervention useful in improving psychological distress and academic motivation
* which psychological variables predict the intervention outcome conditions: University Students conditions: Psychological Intervention conditions: Psychological Distress studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Four weekly psychological counselling intervention primaryPurpose: OTHER masking: NONE count: 100 type: ESTIMATED name: four weekly psychological counselling intervention measure: psychological distress measure: Academic motivation measure: Emotion regulation ability measure: perceived loneliness measure: drop-out intention sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: University of Campania status: RECRUITING city: Caserta zip: 81100 country: Italy name: ALDA TRONCONE role: CONTACT email: alda.troncone@unicampania.it lat: 41.07262 lon: 14.33231 hasResults: False

 nctId: NCT06333431 id: WN/WF briefTitle: Effects of WN and WF During Gastroscopy acronym: WF/WN_GCPY overallStatus: NOT_YET_RECRUITING date: 2024-04-03 date: 2024-05-30 date: 2024-06-08 date: 2024-03-27 date: 2024-03-27 name: Suleyman Demirel University class: OTHER briefSummary: Background: Gastroscopy is an endoscopic procedure that allows examination of the upper gastrointestinal system, including the esophagus, stomach and duodenum. The procedure is a difficult and stressful diagnosis and treatment method for the patient. Problems such as stress, fear and pain experienced during endoscopy cause anxiety.

Purpose: To examine effects of glass waterfall and white noise on pain, anxiety and physiological parameters during gastroscopy Method: The population of the study consists of all patients who applied to Mardin Education and Research Hospital, Department of General Surgery, Endoscopy Unit and were scheduled for gastroscopy. The sample will be represented by 156 patients whose gastroscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample. In calculating the sample of the study, power analysis was performed and it was found the effect size of 1.16, 95% power and 0.05% margin of error for this study, that a total of 156 individuals for the three groups and at 52 individuals for each group. Before gastroscopy procedure, the patients included in the study will be randomly divided into three groups: 52 glass waterfall group, 52 white noise group and 52 control group. conditions: Misadventure During Endoscopic Examination studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment experimental model using randomized pretest and posttest with control group primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 156 type: ESTIMATED name: Glass Waterfall group name: white noise group measure: Patient Information Form measure: Visual Analogue Scale (VAS) measure: State and Trait Anxiety Scale (STAI) measure: The Patient Observation Form measure: Pulse rate before and after gatroscopy procedure measure: Respiratory rate before and after gatroscopy procedure measure: Systolic and diastolic blood pressure before and after gatroscopy procedure measure: Oxygen saturation values before and after gatroscopy procedure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06333418 id: VR/WF briefTitle: Effects of VR and Glass WF Colonoscopy acronym: VR/WN_colon overallStatus: NOT_YET_RECRUITING date: 2024-04-03 date: 2024-05-30 date: 2024-06-08 date: 2024-03-27 date: 2024-03-27 name: Suleyman Demirel University class: OTHER briefSummary: Background: Today, colonoscopy is widely used in many diseases, especially in the screening and diagnosis of colorectal cancers. Colonoscopy is considered a procedure that disturbs the patient's comfort because it is a very invasive and painful procedure. Along with physical discomfort during the procedure, it triggers emotional disturbances such as fear, and anxiety in the patient.

Purpose: To examine the effect of virtual rain forest and glass waterfall on satisfaction, comfort, anxiety, and vital signs before colonoscopy Method: The population of the study consists of all patients who applied to Mardin Education and Research Hospital, Department of General Surgery, Endoscopy Unit and were scheduled for colonoscopy. The sample will be represented by 135 patients whose colonoscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample. In calculating the sample of the study, power analysis was performed and it was found the effect size of 0.40, 95% power and 0.01% margin of error for this study, that a total of 135 individuals for the three groups and at 60 individuals for each group. G\*Power, version 3.0.10 was used for statistical power analysis. The study group of 93 people to participate in the study will be divided into three equal groups in accordance with the random numbers table obtained the computer- based Research Randomizer program. Before the arthroscopy procedure, the patients included in the study will be randomly divided into three groups: 45 rain forest video VR group, 45 glass waterfall group and 45 control group. All participants in the study will first fill out a patient identification form containing patient demographic information. conditions: Misadventure During Endoscopic Examination studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment experimental model using randomized pretest and posttest with control group primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Double (Participant, Investigator) whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 135 type: ESTIMATED name: Virtual Reality Glasses Group name: Glass waterfall measure: Patient Information Form measure: Visual Analogue Scale (VAS) measure: State and Trait Anxiety Scale (STAI) measure: The Patient Observation Form measure: Pulse rate before colonoscopy procedure measure: Respiratory rate before colonoscopy procedure measure: Systolic and diastolic blood pressure before colonoscopy procedure measure: Oxygen saturation values before colonoscopy procedure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06333405 id: FMTNEC/01/2024 briefTitle: Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-01-31 date: 2025-01-31 date: 2024-03-27 date: 2024-03-27 name: Medical University of Warsaw class: OTHER briefSummary: The aim of the study is to assess the safety of fecal microbiota transplantation (FMT) as a preventive method for the development of Necrotizing enterocolitis (NEC) in a group of premature infants.

This is the first stage of a clinical trial testing the effectiveness of FMT in NEC, the aim of which is to examine the safety profile and analyze all side effects. conditions: Necrotizing Enterocolitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: single group, open label, observational study with intervention (FMT) primaryPurpose: PREVENTION masking: NONE count: 20 type: ESTIMATED name: Fecal Microbiota Transplantation measure: Adverse reactions monitoring sex: ALL minimumAge: 24 Weeks maximumAge: 36 Weeks stdAges: CHILD facility: Medical University of Warsaw, Pediatric Surgery Clinic city: Warsaw state: Mazovian Voivodeship zip: 02-097 country: Poland name: Marek Wolski, MD, PhD role: CONTACT phone: 665578922 phoneExt: +48 email: marek.wolski@wum.edu.pl name: Ewa A. Biegańska, MD role: CONTACT phone: 692542543 phoneExt: +48 email: ewa.bieganska@wum.edu.pl lat: 52.22977 lon: 21.01178 hasResults: False

 nctId: NCT06333392 id: TotalUnderwater_REK577567 briefTitle: Total Underwater Colonoscopy (TUC) for Improved Colorectal Cancer Screening: A Randomized Controlled Trial overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-12 date: 2024-03-27 date: 2024-03-27 name: Vestre Viken Hospital Trust class: OTHER name: Ullevaal University Hospital name: Sahlgrenska University Hospital, Sweden name: Ostfold Hospital Trust briefSummary: Colorectal cancer (CRC), the third most diagnosed cancer and second most common cause of cancer death. CRCs develop from precursors like adenomas (about 70% of CRCs) or serrated lesions (SSLs) (about 25-30% of CRCs). Colonoscopy is the cornerstone in CRC screening, in screening programmes often as a work-up examination after a positive primary screening test such as faecal immunochemical test (FIT). Norway and Sweden have recently launched a nationwide faecal haemoglobin CRC screening programmes. Recently, both a Dutch and an Austrian study showed that SSL detection rate (SSLDR) is inversely correlated to CRC at follow-up. Consequently, improved SSLDR can reduce the risk of post-colonoscopy CRC. SSLs are typically located in the right colon. They are flat, with indistinctive boarders, and consequently easily missed or incompletely resected. A Norwegian study showed incomplete resection of 40% of proximal SSLs. The prevalence of SSLs is higher in women than in men, with women being on a threefold risk of developing CRC from SSLs. It seems like post-colonoscopy CRC more often is caused by SSLs than by adenomas. Total underwater colonoscopy (TUC) is a technique replacing conventional CO2 insufflation by water infusion to distend the lumen and visualise the mucosa during withdrawal of the colonoscope and simultaneously removal of water. There are several reasons to advocate TUC:

1. SSLs will be more visible as they "float" on the submucosa and contract into the lumen, while full distension by gas stretches the mucosa, making detection of flat lesions more difficult.
2. Water works like a magnifying lens, making detection and detailed characterisation of lesions easier.
3. uEMR is eased.
4. Improved bowel cleansing

The goal of this clinical trial is to compare colonoscopy outcomes for standard gas (CO2) insufflation and TUC during withdrawal in patients participating in colonoscopy in the Norwegian and Swedish colorectal cancer screening programme after a positive fecal immunochemical test.

The overarching research questions of the present trial is whether colonoscopy outcomes are improved when CO2 insufflation is replaced by TUC during withdrawal and whether the new technique reduces the ecological footprint of the colonoscopy examination.

The project has five main hypotheses:

1. TUC is superior to the standard approach (CO2 withdrawal) regarding detection of proximal SSLs.
2. TUC increases the rate of complete resection of lesions \&gt;= 10mm.
3. TUC reduces the rate of painful colonoscopies and vasovagal reactions.
4. TUC reduces the health care costs by reduced use of single use accessories and reduced number of redundant colonoscopies to obtain polypfree colon.
5. TUC reduces the carbon footprint by reduced use of single use accessories.

If TUC is superior to gas insufflation, the technique may be implemented rapidly since the technique is easy to learn. This study will increase endoscopy competence at participating centres. The centres are involved in national colonoscopy training programs, so the technique will quickly be passed on to other hospitals and screening centres.

The trial can be linked to three of the Global Goals:

* Good health and well-being: The increased detection and improved complete removal of sessile serrated lesions can subsequently decrease the risk of CRC and CRC mortality during follow-up. TUC will probably reduce the rate of painful procedures and vasovagal reactions and thus increase the acceptance of a screening programme. Consequently, the project can contribute significantly to improve screening effectiveness in Norway and Sweden, particularly in women (women have a higher risk for SSLs and a higher risk of colorectal cancer developing from this type of precursor).
* Gender equality: Women have a similar lifetime risk for CRC as men but less benefit of screening regardless of whether they are screened by sigmoidoscopy, FIT or colonoscopy. The reason is probably missed sessile serrated lesions in the proximal colon. If TUC improves SSLDR and complete lesion resection, this may lead to an equal benefit from CRC screening for women and men. Women have also a higher risk of discomfort and pain during colonoscopy than men. It has been shown that women prefer non-invasive screening modalities, potentially to avoid pain during colonoscopy, even if colonoscopy may be the most beneficial screening method for women. If TUC reduces the rate of painful colonoscopies, it can reduce women's barriers to attend screening.
* Responsible consumption and production: The TUC technique will also reduce the ecological footprint of colonoscopy activity due to reduced consumption of single use accessories and reduced number of colonoscopies to achieve polyp free colon. Furthermore, the cost for the health care system will be substantially reduced. conditions: Colorectal Neoplasia conditions: Screening Colonoscopy conditions: Colorectal Cancer conditions: Colorectal Cancer Screening conditions: Vasovagal Reaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 1070 type: ESTIMATED name: Total underwater colonoscopy name: Conventional colonoscopy measure: Proximal sessile serrated lesion detection rate measure: Complete resection rate for lesions > 10mm measure: Rate of painful procedures and vasovagal reactions measure: Leakage after colonoscopy measure: Detection rate for other neoplasia than SSL measure: Withdrawal time measure: Total procedure time measure: Bowel cleansing quality measure: Complications measure: Number of colonoscopies to achieve polyp free colon measure: Single use accessories for the procedure sex: ALL minimumAge: 55 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06333379 id: SichuanPPHLC04 id: 2020LY01 type: OTHER_GRANT domain: Sichuan Provincial People's Hospital briefTitle: Aspergillosis Detection Via EBC-GM in Ventilated Patients overallStatus: COMPLETED date: 2023-01-02 date: 2023-12-30 date: 2024-01-10 date: 2024-03-27 date: 2024-03-27 name: Lin Chen class: OTHER briefSummary: Brief Research Proposal: Non-Invasive Detection of Invasive Pulmonary Aspergillosis in ICU Patients Background: Invasive Pulmonary Aspergillosis (IPA) is a critical threat to patients in ICUs, especially those undergoing mechanical ventilation. Traditional diagnostic methods are invasive and carry risks. This study proposes a non-invasive, innovative approach utilizing galactomannan (GM) analysis in Exhaled Breath Condensate (EBC) for early IPA detection.

Objective: To evaluate the diagnostic accuracy of measuring GM levels in EBC for detecting IPA in mechanically ventilated patients, comparing it against the conventional Bronchoalveolar Lavage Fluid (BALF)-GM measurements.

Methods: A clinical trial will be conducted with 75 mechanically ventilated patients suspected of having IPA. The study will compare the effectiveness of EBC-GM levels against BALF-GM levels in diagnosing IPA, focusing on sensitivity, specificity, and diagnostic accuracy. The novel, self-designed EBC collection device will facilitate the safe and efficient collection of EBC from patients.

Expected Outcomes:

Validation of EBC-GM Diagnostic Accuracy: Anticipate demonstrating that EBC-GM levels provide a comparable diagnostic accuracy to BALF-GM, establishing a non-invasive, safer alternative for IPA detection.

Implementation of a Non-Invasive Diagnostic Tool: The study aims to introduce a non-invasive diagnostic approach that can potentially replace more risky, invasive methods, improving patient care in ICUs.

Contribution to Clinical Practice: By providing a new method for early and safer detection of IPA, the study is expected to influence clinical guidelines and practices in the management of critically ill, ventilated patients.

Significance: This research has the potential to revolutionize the diagnosis of fungal infections in critically ill patients by offering a non-invasive, accurate, and safer diagnostic tool, thereby improving patient outcomes and reducing the risks associated with invasive diagnostic procedures. conditions: Bronchoalveolar Lavage Fluid conditions: Sensitivity and Specificity conditions: Critical Illness conditions: Respiration Failure conditions: Respiratory Fungal Infection conditions: Exhaled Breath Condensate conditions: Aspergillosis, Invasive Pulmonary studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 75 type: ACTUAL name: Compare the levels of Galactomannan (GM) levels in exhaled breath condensate (EBC) and BALF measure: Diagnostic accuracy of EBC-GM vs. BALF-GM measure: EBC-GM levels: measure: Correlation between EBC-GM and BALF-GM levels sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Provincial People's Hospital city: Chengdu state: Sichuan zip: 86610072 country: China lat: 30.66667 lon: 104.06667 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-04-12 uploadDate: 2024-03-22T15:01 filename: Prot_SAP_000.pdf size: 81579 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-04-12 uploadDate: 2024-03-22T15:02 filename: ICF_001.pdf size: 133154 hasResults: False

 nctId: NCT06333366 id: 202301590A0C501 id: Application No.2402020052 type: OTHER domain: Chang Gung Memorial Hospital briefTitle: First-In-Human Study of PDT to Detect IAH overallStatus: RECRUITING date: 2024-02-18 date: 2024-07-16 date: 2025-09-20 date: 2024-03-27 date: 2024-03-27 name: Chang Gung Memorial Hospital class: OTHER name: DOTSPACE briefSummary: PDT is a continuous pressure monitoring for Intra-Abdominal hypertension (IAH) designed to be less invasive than pan-endoscopic evaluation, more tolerable than abdominal tapping, and more effective than intravesical pressure measurement for IAH. The PDT device consists of a piezoelectric sensor module with a low power Bluetooth wireless transmitter encased in biocompatible capsule. The device will be swallowed after activation. Following PDT insertion, the patient is fitted with a custom, removable external waist accessory containing a receiver, which is worn during monitoring and provide PDT location by signal analysis with sufficient information to provide IAH trends. conditions: Intra-Abdominal Hypertension studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 10 type: ESTIMATED name: Intra-gastrointestinal monitoring device (PDT) measure: Incidence of device-related or sensor insertion/removal procedure-related adverse events measure: Rate of foreign body reaction due intra-gastrointestinal insertion measure: Rate of GI symptoms, i.e. inflammation, infection, diarrhea, bowel obstruction, and ileus measure: Incidence of sensor failure measure: Percentage of users feedback in the form of clinical questionnaire to assess the 'easiness' of insertion procedure with questionnaire measure: Duration of PDT insertion and explantation procedure measure: Incidence of side effects in Post explantation follow-up measure: Rate of GI dysfunction after 10 days post explantation of the PDT sensor. Follow-up via phone call after 30 days measure: Rate of sensor ability to measure intra-gastrointestinal pressure (IGP) to allow the development of the algorithm measure: Incidence of influence of interference substances (i.e. water, saliva, gastric juice, bile, intestinal secretion, feces, and food debris ) sex: ALL minimumAge: 20 Years maximumAge: 55 Years stdAges: ADULT facility: Dong-Ru Ho status: RECRUITING city: Chiayi City zip: 60061 country: Taiwan name: Dong-Ru Ho, MD, PhD role: CONTACT phone: 886-975353211 email: redoxdrh@gmail.com role: CONTACT phoneExt: Ho email: redoxdrh@gmail.com name: Dong-Ru Ho, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 23.47917 lon: 120.44889 hasResults: False

 nctId: NCT06333353 id: H-06-23-9278 briefTitle: Is Repetitive Transcranial Magnetic Stimulation Effective in Reducing Endometriosis-associated Pain overallStatus: RECRUITING date: 2024-04-12 date: 2027-05-20 date: 2027-06-20 date: 2024-03-27 date: 2024-04-15 name: University of Ottawa class: OTHER briefSummary: The goal of this research is to improve pain outcomes for the over 500K Canadian women, girls and gender-diverse individuals who are newly diagnosed with endometriosis each year. Chronic pain that persists after interventions for endometriosis is a huge problem. There is some evidence that endometriosis-associated pain (EAP) is, at least to some extent, associated with changes in pain physiology, particularly central sensitization of pain. There is currently no effective evidence-informed intervention that addresses EAP. Yet a recent feasibility trial on a repetitive transcranial magnetic stimulation (rTMS) intervention demonstrated promising results compared to a sham intervention for reducing pain in a sample with EAP.

The objectives of this trial are:

1. to evaluate the effectiveness of an rTMS intervention for pain reduction among those with recalcitrant post-operative EAP,
2. to inform on the utility of a long (10 session) vs short (5 session) protocol for pain reduction among those with recalcitrant post-operative EAP
3. to determine if any improvements in pain observed 30 days after an rTMS intervention are retained 6 months later
4. to identify physical and psychosocial mediators that impact the successful reduction of pain among patients with EAP treated using rTMS.
5. to describe patients' perceptions of and satisfaction with rTMS as an intervention for EAP. conditions: Endometriosis conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: All participants, care providers, investigators and outcome assessors will remain blinded to real/sham intervention. The outcomes assessor and the investigator will remain blinded to intervention duration. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 152 type: ESTIMATED name: Real RepetitiveTranscranial Magnetic Stimulation 5 sessions name: Sham RepetitiveTranscranial Magnetic Stimulation 5 sessions name: Real RepetitiveTranscranial Magnetic Stimulation 10 sessions name: Sham RepetitiveTranscranial Magnetic Stimulation 10 sessions measure: Numeric rating scale (NRS) used to record daily pain over 30 days measure: Numeric rating scale(NRS) used to record daily pain over 30 days measure: Patient Global Impression of Change (PGIC) in pain measure: Patient Global Impression of Change (PGIC) in pain measure: Patient Global Impression of Change (PGIC) in pain measure: The Beck Depression Inventory (BDI-II) measure: The Beck Depression Inventory (BDI-II) measure: The Beck Depression Inventory (BDI-II) measure: The State-Trait Anxiety Inventory (STAI) measure: The Pain Catastrophizing Scale measure: The Central sensitization index measure: Female Sexual Distress Scale (FSDS) measure: Adherence to the intervention protocol measure: Pressure pain threshold (PPThresh) measure: Pressure pain threshold (PPThresh) measure: Pressure Pain Tolerance (PPTol) measure: Pressure Pain Tolerance (PPTol) measure: Perceived pain intensity (PPI) measure: Perceived pain intensity (PPI) measure: Temporal summation (TS) of pain measure: Temporal summation (TS) of pain measure: Pain rating during the tampon test measure: Pain rating during the tampon test measure: Conditioned pain modulation (CPM) measure: Conditioned pain modulation (CPM) measure: The Brief Pain Inventory measure: The Brief Pain Inventory measure: The Brief Pain Inventory measure: The Endometriosis Health Profile Questionnaire (EPH-30) measure: The Endometriosis Health Profile Questionnaire (EPH-30) measure: The Endometriosis Health Profile Questionnaire (EPH-30) measure: Patient satisfaction with treatment (PST) measure: Patient satisfaction with treatment (PST) measure: Patient satisfaction with treatment (PST) sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: McLean Function Measurement Lab status: RECRUITING city: Ottawa state: Ontario zip: K1S1S2 country: Canada name: Anne-Marie MacDonald, MSc role: CONTACT phone: 613-562-5800 phoneExt: 4102 email: mfmlab@uottawa.ca name: Linda McLean, PhD role: CONTACT phone: 613-562-5800 phoneExt: 4102 email: lmclea2@uottawa.ca name: Linda McLean, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.41117 lon: -75.69812 hasResults: False

 nctId: NCT06333340 id: 24-03 briefTitle: Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-03 date: 2024-03-27 date: 2024-04-12 name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital class: OTHER briefSummary: The goal of this study is to compare 2 medications that are commonly used to prevent excess uterine bleeding (postpartum hemorrhage, or PPH) following cesarean delivery (CD), oxytocin and carbetocin. Most of the trials evaluating the preventative role of oxytocin and carbetocin after CD have focused on patient with low-risk of PPH.

This trial will focus on patients that are at increased risk of PPH, with risk factors such as: multiple gestation (twins, or more multiples), large baby, polyhydramnios (excess amniotic fluid), history of PPH, body mass index greater than 40, diabetes mellitus, hypertension, and placenta previa.

The investigators hypothesize that carbetocin would be more effective than an oxytocin regimen in reducing the risk of PPH in patients undergoing CD with any of the biological high-risk factors. conditions: Post Partum Hemorrhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: Oxytocin name: Carbetocin measure: Proportion of parturients requiring additional uterotonic agents intraoperatively measure: Uterine Tone 3 minutes measure: Uterine Tone 5 minutes measure: Uterine Tone 10 minutes measure: Calculated blood loss (CBL) measure: Semi-quantitative blood loss (SQBL) measure: Presence of blood transfusion measure: Number of patients with ICU admission measure: Number of patients with conservative surgical methods to manage post partum hemorrhage measure: Number of patients with radiological methods used to manage post partum hemorrhage measure: Number of patients with surgical post partum hemorrhage management measures measure: Number of patients with hypotension defined as systolic blood pressure less than 80% of baseline measure: Number of patients with hypertension defined as systolic blood pressure greater than 120% of baseline measure: Number of patients with tachycardia defined as heart rate greater than 130% of baseline measure: Number of patients with bradycardia defined as heart rate less than 70% of baseline measure: Presence of ventricular tachycardia: ECG measure: Presence of atrial fibrillation: ECG measure: Presence of atrial flutter: ECG measure: Presence of nausea: questionnaire measure: Presence of vomiting: questionnaire measure: Number of patients with chest pain: questionnaire measure: Number of patients with shortness of breath: questionnaire measure: Number of patients with headache: questionnaire measure: Number of patients with flushing: questionnaire sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Mount Sinai Hospital city: Toronto state: Ontario zip: M5G1X5 country: Canada name: Mrinalini Balki, MD role: CONTACT phone: 416-586-4800 phoneExt: 5270 email: mrinalini.balki@uhn.ca name: Narinder Singh, MD role: SUB_INVESTIGATOR name: Ronald George, MD role: SUB_INVESTIGATOR name: Kristi Downey, MSc role: SUB_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06333327 id: 1432022000278 briefTitle: Multicenter Registry of Atrial Fibrillation Ablation With Radiofrequency Balloon Catheter acronym: COLLABORATE overallStatus: RECRUITING date: 2021-01-01 date: 2030-01-01 date: 2030-12-01 date: 2024-03-27 date: 2024-03-27 name: Universitair Ziekenhuis Brussel class: OTHER briefSummary: All consecutive patients with paroxysmal or persistent atrial fibrillation undergoing pulmonary vein isolation with the radiofrequency balloon catheter (RFB) "Heliostar" (Biosense Webster) will be included in a multicenter observational registry. The aim of the study is to assess the safety and arrhythmic outcome of atrial fibrillation ablation with the RFB in a real-world setting. conditions: Atrial Fibrillation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: Pulmonary vein isolation with the multielectrode radiofrequency balloon catheter measure: Atrial arrhythmia recurrence after ablation measure: Procedural safety sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Brussel Heart Rhythm Management Center status: RECRUITING city: Brussels zip: 1090 country: Belgium name: Carlo de Asmundis, MD, PhD role: CONTACT phone: +32024763704 email: hrmc@uzbrussel.be lat: 50.85045 lon: 4.34878 hasResults: False

 nctId: NCT06333314 id: UC-IMM-2302 briefTitle: Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI acronym: Pan-MSI-ACSE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-10 date: 2030-09 date: 2024-03-27 date: 2024-03-29 name: UNICANCER class: OTHER name: National Cancer Institute, France name: GlaxoSmithKline briefSummary: The goal of this open-label randomized, multicenter, comparative phase II trial is to evaluate the efficacy of the immunotherapy, dostarlimab, as first-line treatment for deficient mismatch repair (dMMR)/microsatellite instability (MSI) non-resectable metastatic or locally advanced non-colorectal and non-endometrial cancers compared to the standard of care chemotherapy.

Adult patients (aged ≥18 years) with histologically confirmed dMMR/MSI duodenum and small bowel adenocarcinoma, gastric and oeso-gastric junction (OGJ) adenocarcinoma with combined positive score (CPS)\<5, pancreatic adenocarcinoma, ampulla of vater adenocarcinoma, adrenocortical carcinoma, carcinoma of unknown primary site, neuroendocrine carcinoma (Grade3) all primary, and soft tissue sarcoma (except Gastro-Intestinal Stromal Tumor) will be included in this study. They will be randomized and treated with either dostarlimab (experimental arm A), or chemotherapy (control arm B).

Patients with documented disease progression following the first line chemotherapy (Arm B) may be eligible for crossover to be treated with dostarlimab, with the same schedule as arm A. conditions: Pancreatic Adenocarcinoma conditions: Ampulla of Vater Carcinoma conditions: Adrenocortical Carcinoma conditions: Neuroendocrine Carcinoma conditions: Soft Tissue Sarcoma conditions: Small Bowel Adenocarcinoma conditions: Duodenum Adenocarcinoma conditions: Gastric Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, multicenter, comparative phase II trial primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Dostarlimab name: Chemotherapy measure: Progression-free survival measure: Objective Response Rate measure: Duration of response measure: Overall Survival measure: Progression-Free Survival 2 measure: Objective response rate 2 measure: Progression-Free Survival -crossover measure: Circulating tumor DNA level measure: Incidence of treatment-emergent adverse events measure: Quality of life questionnaire - Core 30 (QLQ-C30) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institut de Cancérologie de l'Ouest city: Angers country: France name: Victor SIMMET, MD role: CONTACT lat: 47.46667 lon: -0.55 facility: Institut du Cancer Avignon-Provence city: Avignon country: France name: Clémence TOULLEC, MD role: CONTACT lat: 43.94834 lon: 4.80892 facility: CHU Jean Minjoz city: Besançon country: France name: Angélique VIENOT, MD role: CONTACT lat: 47.24878 lon: 6.01815 facility: CHU Morvan city: Brest country: France name: Pierre-Guillaume POUREAU, MD role: CONTACT lat: 48.3903 lon: -4.48628 facility: Centre François Baclesse city: Caen country: France name: Elodie COQUAN, MD role: CONTACT lat: 49.18585 lon: -0.35912 facility: Centre Jean Perrin city: Clermont-Ferrand country: France name: Florence OSAER-POLYCARPE, MD role: CONTACT lat: 45.77966 lon: 3.08628 facility: CHU - Henri Mondor city: Créteil country: France name: Christophe TOURNIGAND, MD role: CONTACT lat: 48.78333 lon: 2.46667 facility: Centre Georges François Leclerc city: Dijon country: France name: François GHIRINGHELLI, MD role: CONTACT lat: 47.31667 lon: 5.01667 facility: Centre Léon Bérard city: Lyon country: France name: Clélia COUTZAC, MD role: CONTACT lat: 45.74848 lon: 4.84669 facility: Hôpital la Timone city: Marseille country: France name: Laëtitia DAHAN, MD role: CONTACT lat: 43.29551 lon: 5.38958 facility: Institut Paoli Calmettes city: Marseille country: France name: Christelle DE LA FOUCHARDIERE, MD role: CONTACT lat: 43.29551 lon: 5.38958 facility: Institut de Cancérologie de Lorraine city: Nancy country: France name: Aurélien LAMBERT, MD role: CONTACT lat: 48.68439 lon: 6.18496 facility: Institut Mutualiste Montsouris city: Paris country: France name: Raphaël COLLE, MD role: CONTACT lat: 48.85341 lon: 2.3488 facility: CHU de Bordeaux - Hôpital Haut -Lèvêque city: Pessac country: France name: Denis SMITH, MD role: CONTACT lat: 44.81011 lon: -0.64129 facility: CHU de Poitiers city: Poitiers country: France name: David TOUGERON, MD role: CONTACT lat: 46.58333 lon: 0.33333 facility: Institut Jean Godinot city: Reims country: France name: Damien BOTSEN, MD role: CONTACT lat: 49.25 lon: 4.03333 facility: Centre Eugène Marquis city: Rennes country: France name: Héloïse BOURIEN, MD role: CONTACT lat: 48.11198 lon: -1.67429 facility: CHU de Rouen city: Rouen country: France name: Frédéric DI FIORE, MD role: CONTACT lat: 49.44313 lon: 1.09932 facility: Institut de Cancérologie de l'Ouest city: Saint-Herblain country: France name: Sandrine HIRET, MD role: CONTACT lat: 47.21765 lon: -1.64841 facility: CHU de Toulouse Hôpital Rangueil city: Toulouse country: France name: Rosine GUIMBAUD, MD role: CONTACT lat: 43.60426 lon: 1.44367 facility: Gustave Roussy Grand Paris city: Villejuif country: France name: Cristina SMOLENSCHI, MD role: CONTACT lat: 48.7939 lon: 2.35992 facility: Hôpital Saint-Antoine city: Paris state: Île-de-France country: France name: Thierry ANDRE, MD role: CONTACT lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06333301 id: TIME-ZZZ briefTitle: Translational Initiative to Map Epigenetics in Sleep acronym: TIME-ZZZ overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2034-04 date: 2034-04 date: 2024-03-27 date: 2024-03-27 name: Elysium Health class: INDUSTRY name: University of Oxford briefSummary: The primary aim of TIME-ZZZ is to explore the relationship between chronotype, incidence of depression and biological age, and whether individuals working "out-of-phase" with their chronotype are more likely to exhibit signs of depression and accelerated biological aging. conditions: Biological Aging studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10000 type: ESTIMATED name: Surveys measure: Effect of being "out of phase" with chronotype on biological age measure: Effect of Chronotype Alignment and Depression Risk in Relation to Rate of Aging measure: Identification of DNA methylation markers associated with chronotype measure: Identification of DNA methylation markers associated with depression sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06333288 id: 2024-0268 briefTitle: Pilot Trial to Evaluate PROblem Solving Therapy and APPLE Watch for College Students overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-11-30 date: 2025-03-30 date: 2024-03-27 date: 2024-03-27 name: University of Illinois at Chicago class: OTHER briefSummary: The goals of this Pilot Trial are to test the preliminary efficacy of Problom-Solving Therapy (PST)-APPLE Watch in a 2-arm pilot Randomized Control Trial (RCT), vs education only-control to reduce alcohol use disorder symptoms and improve alcohol abstinence. conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: PRO-APPLE Study is a 2-arm pilot Randomized Control Trial (RCT). primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: PST-APPLE Watch group name: Education-only control group measure: Alcohol abstinence measure: Change in AUD severity at 3 months. measure: Change in AUD frequency status. measure: Change in Alcohol-related negative consequences at 3 months. measure: Change in Alcohol use at 3 months. measure: Change in Reasons for drinking at 3 months. measure: Change in negative affect at 3 months. measure: Change in positive affect at 3 months. measure: Change in Cognitive performance (executive cognitive ability and attention and working memory) at 3 months. measure: Change in the quality of life at 3 months. measure: Percent heavy drinking days at 3 months. measure: Percent binge drinking days at 3 months. measure: Percent days abstinence at 3 months. measure: Intervention Acceptability measure: Intervention Fidelity measure: Participant Retention measure: Protocol Acceptability sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: University of Illinois at Chicago city: Chicago state: Illinois zip: 60608 country: United States name: Hagar Hallihan role: CONTACT lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06333275 id: DLF-Nr: 5564 id: BASEC-Nr: 2023-01141 type: OTHER domain: BASEC (Business Administration System for Ethics Committees) - Switzerland briefTitle: Restoration of Immunity to Vaccine Preventable Diseases After CART-T Cell Therapy acronym: IMCAR overallStatus: RECRUITING date: 2023-11-14 date: 2025-12 date: 2026-12 date: 2024-03-27 date: 2024-03-27 name: Insel Gruppe AG, University Hospital Bern class: OTHER briefSummary: The goal of this observational study is to learn about vaccine immunity in patients with B-cell malignancies treated by chimeric antigen receptor T-cell therapies (CAR-T). The main questions it aims to answer are:

* Do CAR-T cell therapy recipients lose vaccine protection against common vaccine-preventable pathogens
* Are current re-vaccination recommendations sufficient in restoring vaccine-protection
* Is this restored vaccine-protection after CAR-T cell therapy lost faster than usual
* Do clinical or immunological factors predict vaccine response after CAR-T cell therapy conditions: Vaccine Immunity in CAR-T Cell Therapy Recipients studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Vaccines against: Diphtheria, tetanus, pertussis, polio, haemophilus influenza type b, varicella and measles measure: CAR-T cell therapy associated change in antibody levels against 5 vaccine preventable pathogens measure: Rate of seroprotection against tetanus 6 months after CAR-T cell therapy measure: Rate of seroprotection against haemophilus influenza type B 6 months after CAR-T cell therapy measure: Rate of seroprotection against hepatitis B virus 6 months after CAR-T cell therapy measure: Rate of seroprotection against poliovirus 6 months after CAR-T cell therapy measure: Rate of seroprotection against measles virus 12 months after CAR-T cell therapy measure: Rate of seroprotection against tetanus after re-vaccination following CAR-T cell therapy measure: Rate of seroprotection against haemophilus influenza type B after re-vaccination following CAR-T cell therapy measure: Rate of seroprotection against hepatitis B virus after re-vaccination following CAR-T cell therapy measure: Rate of seroprotection against poliovirus after re-vaccination following CAR-T cell therapy measure: Rate of seroprotection against measles after re-vaccination following CAR-T cell therapy measure: Clinical predictors of vaccine elicited immune response measure: Immunological predictors of vaccine elicited immune response measure: Persistence of vaccine elicited seroprotection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Bern status: RECRUITING city: Bern zip: 3010 country: Switzerland name: Lukas N Baumann, MD role: CONTACT phone: +41 31 66 4 30 69 email: lukas.baumann2@insel.ch name: Cédric Hirzel, PD, MD role: CONTACT phone: +41 31 66 4 01 17 email: cedric.hirzel@insel.ch name: Christine Thurnheer Zürcher, PD, MD role: PRINCIPAL_INVESTIGATOR name: Cédric Hirzel, PD, MD role: PRINCIPAL_INVESTIGATOR name: Lukas N Baumann, MD role: SUB_INVESTIGATOR name: Urban Novak, Professor role: SUB_INVESTIGATOR lat: 46.94809 lon: 7.44744 hasResults: False

 nctId: NCT06333262 id: 24-017 briefTitle: Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia overallStatus: RECRUITING date: 2024-04 date: 2027-02-01 date: 2029-02-01 date: 2024-03-27 date: 2024-04-23 name: Inhye Ahn class: OTHER name: Loxo Oncology, Inc. briefSummary: This study will evaluate fixed-duration therapy with pirtobrutinib and obinutuzumab given over 12 cycles (approximately 1 year) as first-line treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL or SLL). conditions: Chronic Lymphocytic Leukemia conditions: Small Lymphocytic Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Pirtobrutinib name: Obinutuzumab measure: Rate of complete response after initial therapy measure: Overall response rate measure: Rate of partial response measure: Time to next line of therapy measure: Event-free survival measure: Progression-free survival measure: Overall survival measure: Rate of re-treatment with pirtobrutinib sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beth Israel Deaconess Medical Center status: RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Jon Arnason, MD role: CONTACT name: Jon Arnason, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Brigham & Women's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Inhye Ahn role: CONTACT name: Inhye Ahn, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Dana-Farber Cancer Institute status: RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Megan Forsyth role: CONTACT phone: 857-215-1405 email: megan_forsyth@dfci.harvard.edu name: Inhye Ahn, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06333249 id: AGTC-RPGR-001 SKYLINE briefTitle: A Study Comparing Two Doses of AGTC-501 in Male Subjects With X-linked Retinitis Pigmentosa Caused by RPGR Mutations (SKYLINE) overallStatus: ACTIVE_NOT_RECRUITING date: 2021-04-13 date: 2023-04-11 date: 2027-02 date: 2024-03-27 date: 2024-03-27 name: Beacon Therapeutics class: INDUSTRY briefSummary: This study will evaluate the safety and efficacy of a recombinant adeno-associated virus vector (rAAV2tYF-GRK1-RPGR) in patients with X-linked retinitis pigmentosa caused by RPGR mutations. conditions: X-Linked Retinitis Pigmentosa studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The purpose of the Phase 2 study is to evaluate the efficacy, safety, and tolerability of two doses of AGTC-501 in male subjects between 8 - 50 years of age (inclusive) with XLRP genetically confirmed by at least one pathogenic variant in the RPGR gene.

Approximately 12 subjects who meet the inclusion criteria, will be randomized in a 1:1 ratio to 1 of 2 treatment groups. Each subject will receive the assigned dose of AGTC-501 in the study eye; no treatment will be administered in the fellow eye. As treatment outcomes in pediatric vs. adult subjects may differ, randomization to dose groups will be stratified by age.

Each subject will receive a central subretinal injection of AGTC-501 at the assigned dose in the central macula of the study eye. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The Phase 2 study is a masked study; therefore, neither the investigator nor the subject will know the dose assignment. Both the subject and the investigator will know which eye received treatment. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 14 type: ACTUAL name: rAAV2tYF-GRK1-RPGR measure: The difference in the proportion of responding eyes between treated and control eyes in the low dose group and high dose group at 12 months, as measured by MAIA microperimetry, where response is defined as a 7dB or more improvement in at least 5 loci. measure: Proportion of responding eyes in treated eyes versus control eyes in the low dose group and the high dose group at Month 12 where responder is defined as an ORA-VNC mobility test score improvement of 2 or more luminance levels. measure: Proportion of responding eyes in treated versus control eyes in the low dose group and the high dose group at Month 12, as measured by MAIA microperimetry, where responder is defined as a 7 dB or more improvement in at least 5 loci within bleb. measure: Proportion of responding eyes in treated vs control eyes in the low dose group and the high dose group at Month 12, measured by MAIA microperimetry where responder is defined as 7 dB or more improvement in at least 5 loci within the central 16 loci measure: Difference in mean change from baseline in the central 36 loci (C36) mean sensitivity, as measured by MAIA microperimetry, in treated eyes versus control eyes in the low dose group and high dose group at Month 12. measure: Difference in mean change from baseline in "within bleb" mean sensitivity, as measured by MAIA microperimetry, in treated eyes versus control eyes in the low dose group and high dose group at Month 12. measure: Difference in mean change from baseline in central 10 degrees of vision on light adapted static perimetry, as measured by Octopus 900, in treated eyes versus control eyes in the low dose group and high dose group at Month 12. measure: Difference in mean change from baseline in BCVA, as measured by ETDRS or tumbling "E" chart, in treated eyes versus control eyes in the low dose group and high dose group at Month 12. measure: Proportion of responding eyes in treated versus control eyes in the low dose group and high dose group at Month 12 where responder is defined as a 10-letter vision gain as measured by ETDRS or tumbling "E" chart. measure: Difference in mean change from baseline in the EZ area, as measured by SD-OCT, in treated eyes versus control eyes in the low dose group and high dose group at Month 12 Visit. measure: Mean change from baseline in Impact of Vision Impairment (IVI) (Weih et al, 2002; Lamoureaux et al, 2007) or Impact of Vision Impairment for Children (IVI-C) (Cochrane et al, 2008) in the low dose group and high dose group at Month 12 Visit measure: Mean change from baseline in Patient Global Impressions of Change (PGI-C) and Patient Global Impressions of Severity (PGIS) in the low dose group and high dose group at Month 12 Visit. sex: MALE minimumAge: 8 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: University of Florida city: Jacksonville state: Florida zip: 32209 country: United States lat: 30.33218 lon: -81.65565 facility: Boston Children's Hosptial city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: Cincinnati Eye Institute city: Cincinnati state: Ohio zip: 45242 country: United States lat: 39.12713 lon: -84.51435 facility: Cleveland Clinic city: Cleveland state: Ohio zip: 44195 country: United States lat: 41.4995 lon: -81.69541 facility: Casey Eye Institute city: Portland state: Oregon zip: 97239 country: United States lat: 45.52345 lon: -122.67621 facility: Retina Foundation of the Southwest city: Dallas state: Texas zip: 75231 country: United States lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06333236 id: OCU_KRON briefTitle: Effect of Kron (Citicoline and Nicotinamide Oral Solution) on Patients With Open-angle Glaucoma overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-09-30 date: 2024-11-30 date: 2024-03-27 date: 2024-03-27 name: ASST Santi Paolo e Carlo class: OTHER briefSummary: Aim of this study is to investigate the administration effects of the combination of citicoline 40mg/ml and nicotinamide 15mg/ml oral solution (Kron®) on short term improvement in inner retinal function, bioelectrical activity of the visual cortex and visual function. conditions: Glaucoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Food for Special Medical Purposes: Kron® measure: Electrofunctional evaluation measure: VF and SD-OCT sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06333223 id: LSC 23/ 396 briefTitle: Polyphenols and Probiotics to Improve Menopausal Symptoms Via the Gut-Brain Axis acronym: SYMPTOGUT overallStatus: RECRUITING date: 2024-03-18 date: 2024-12-18 date: 2025-03-30 date: 2024-03-27 date: 2024-03-29 name: University of Roehampton class: OTHER name: King's College briefSummary: Menopause is one of the most significant lifecourse challenges for women. The decline in female sex hormones, in particular estrogen, during menopause leads to an increased risk in cardiometabolic diseases, and a decrease in quality of life due to symptoms such as low mood, anxiety, hot flushes and difficulty sleeping. As life expectancy continues to increase, on average, women will spend one third of their life in the postmenopausal period. Increasing evidence suggests that the gut microbiota plays a key role in menopause-related symptoms and conditions, being one of the main regulators of circulating sex hormones. Menopause has been linked to gut dysbiosis and lower gut microbial diversity, therefore nutritional strategies targeting the gut microbiome may be an effective approach to improve women's health during menopause. Both (poly)phenols and probiotics are promising candidates for the prevention and treatment of menopausal symptoms via different mechanisms, including the modulation of the gut-brain axis, while emerging evidence indicates that using both together may be a better approach than traditional carbohydrate-based synbiotics.

To our knowledge, the efficacy of a (poly)phenol based synbiotic targeting the gut microbiome for improvement of menopausal symptoms has not been investigated so far. conditions: Menopause studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Arm 1: Mixture of (Poly)phenols and a probiotic supplement Arm 2: (Poly)phenols and maltodextrin (placebo) primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Mixture of (Poly)phenols and a probiotic supplement name: Placebo comparator measure: Change in blood chemistry levels measure: Change in BMI (body mass index) Scores measure: Change in the gut microbiota diversity measure: Change in dietary habits measure: Change in Quality IPAQ measure: Change in inflammatory biomarkes sex: FEMALE minimumAge: 48 Years maximumAge: 60 Years stdAges: ADULT facility: Health Sciences Research Centre, Life Sciences Department, University of Roehampton status: RECRUITING city: London state: UK zip: SW15 4JD country: United Kingdom name: Adele Costabile role: CONTACT lat: 51.50853 lon: -0.12574 facility: Adele Costabile status: RECRUITING city: London zip: SW145JD country: United Kingdom name: Adele Costabile, Prof role: CONTACT name: Zicheng Zhang role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06333210 id: BCD-180-3 briefTitle: Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA) overallStatus: RECRUITING date: 2023-12-25 date: 2024-12 date: 2028-02 date: 2024-03-27 date: 2024-03-27 name: Biocad class: INDUSTRY briefSummary: The aim of the study is to evaluate the efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics of a fixed dose of study drug (BCD-180) in comparison with placebo in patients with active axial spondyloarthritis (axSpA). The study will include HLA-B27+ patients with radiographic (r-axSpA) and non-radiographic (nr-axSpA) who had no response to prior therapy with non-steroidal anti-rheumatic drugs (NSAIDs), have not received biologic disease-modifying anti-rheumatic drugs (bDMARDs) or targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), and subjects with insufficient efficacy and/or loss of efficacy on bDMARDs and/or tsDMARDs. conditions: Axial Spondyloarthritis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 421 type: ESTIMATED name: anti-TRBV9 monoclonal antibody infusions name: Placebo infusions name: Adalimumab subcutaneous injection name: Placebo subcutaneous injection measure: Proportion of subjects who achieved ASAS40 among bDMARDs and tsDMARD-naive subjects measure: Proportion of subjects who achieved ASAS40 among bDMARDs and/or tsDMARD-experienced subjects measure: Proportion of subjects who achieved ASAS40 among subjects with r-axSpA measure: Proportion of subjects who achieved ASAS40 among subjects with nr-axSpA measure: Proportion of subjects with the ASDAS-CRP <1.3 measure: Proportion of subjects with the ASDAS-CRP ≥1.3 - <2.1 measure: Proportion of subjects with the ASDAS-CRP ≥2.1 - ≤3.5 measure: Proportion of subjects with the ASDAS-CRP >3.5 measure: Proportion of subjects who achieved ASDAS-CII (clinically important improvement) measure: Proportion of subjects who achieved ASDAS-MI (Major improvement) measure: ASDAS-CRP change from baseline measure: Proportion of patients who achieved clinical response defined as an improvement of BASDAI by at least 50% compared to baseline measure: Change from baseline in BASDAI measure: Proportion of subjects who achieved ASAS40 measure: Proportion of subjects who achieved ASAS20 measure: Proportion of subjects who achieved ASAS5/6 measure: Proportion of subjects who achieved ASAS partial remission measure: Change from baseline in BASMI measure: Change from baseline in BASFI measure: Change from baseline in the swollen joint count (44 joints) measure: Change from baseline in MASES measure: Change from baseline in overall back pain severity (BASDAI No. 2) measure: Change from baseline in nocturnal back pain severity measure: Change in the patient global assessment of disease activity from baseline measure: Change in the quality of life score assessed with EQ-5D-3L questionnaire from baseline measure: Change from baseline in SF-36 Physical Functioning compared to baseline measure: Change from baseline in SF-36 Mental Health compared to baseline measure: Change in the WPAI score from baseline measure: Change in the ASAS HI score from baseline measure: Change in the concentration of hsCRP from baseline measure: Change in ESR from baseline measure: Changes in the SPARCC score (spine, SIJ) from baseline measure: Changes in mSASSS scores from baseline measure: Proportion of subjects with adverse events measure: Proportion of subjects with serious adverse events measure: Proportion of subjects with grade 3 or higher adverse events according to CTCAE 5.0 measure: Proportion of subjects prematurely withdrawn from the study due to adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chelyabinsk Regional Clinical hospital status: RECRUITING city: Chelyabinsk country: Russian Federation name: Olga Nesmeianova, PhD role: CONTACT phone: +73517493727 email: chelokb@mail.ru lat: 55.15402 lon: 61.42915 facility: State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University status: RECRUITING city: Moscow country: Russian Federation name: Sergey Moiseev, PhD, Doc Med Sci role: CONTACT phone: +7 499 248 25 44 email: clinpharm@mtu-net.ru lat: 55.75222 lon: 37.61556 facility: Clinical Rheumatology Hospital №25 status: RECRUITING city: Saint Petersburg country: Russian Federation name: Inna Gaidukova role: CONTACT phone: +7 (812) 670 30 90 email: b25@zdrav.spb.ru lat: 59.93863 lon: 30.31413 facility: North-Western State Medical University n.a. I.I.Mechnikov status: RECRUITING city: Saint-Petersburg country: Russian Federation name: Vadim Mazurov, PhD role: CONTACT lat: 59.93863 lon: 30.31413 hasResults: False

 nctId: NCT06333197 id: Mandibular condylar fracture briefTitle: Approaches for Open Reduction and Internal Fixation of Mandibular Condylar Fracture overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-01 date: 2025-07-01 date: 2024-03-27 date: 2024-03-28 name: Assiut University class: OTHER briefSummary: The condylar region is the most frequent anatomical site for mandibular fractures .

Condylar fractures constitute 25.5% to 35.5% of all mandibular fractures. The mandibular condyle fracture is a type of fracture that affects the condyle, which is the knuckle-like projection of the mandible (lower jaw) that articulates with the temporal bone to form the temporomandibular joint (TMJ). conditions: Mandibular Fractures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: ALL Patients diagnosed with Extra Capsular Fracture of Mandibular Condyle amenable for surgery. primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: ORIF through transparotid approach name: ORIF through retroparotid approach measure: Facial nerve injury measure: Operative time measure: Fracture stability measure: Mouth opening measure: Other Complication related to the Approach sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06333184 id: 3085-4215 briefTitle: Smoothies and Blood Sugars overallStatus: RECRUITING date: 2024-03-20 date: 2024-08-31 date: 2024-12-31 date: 2024-03-27 date: 2024-03-27 name: University of Bath class: OTHER briefSummary: Glycaemic responses to fruit smoothies may depend on the food matrix (e.g., degree of processing and physical structure), ingestion rate, dose ingested and fibre content. Furthermore, the method of sampling could alter inferences. The aim of this project is to characterise how these factors affect the glycaemic response to a commercially available fruit smoothie. Participants will ingest 7 different test drinks in a randomised, crossover design with fingerstick capillary blood sampling alongside continuous glucose monitors. Test drinks will include a glucose reference (CONTROL), the commercial product matched for carbohydrate to CONTROL (PRODUCT), equivalent carbohydrate ingested as whole fruits (WHOLE), equivalent carbohydrate ingested as blended fruits (WHOLE), equivalent carbohydrate as the commercial product ingested slowly (SLOW), equivalent carbohydrate as the commercial product ingested with additional fibre (FIBRE), and the commercial product ingested in a dose typically bought (DOSE). These data will provide insight into how the food matrix and different patterns of ingestion can alter the glycaemic response to a fruit smoothie, and how the measurement method may alter interpretations. conditions: Metabolic Disturbance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 15 type: ESTIMATED name: Food measure: Glycaemic index of product with capillary vs CGM measure: Glycaemic index of all conditions with capillary vs CGM measure: Condition-by-sampling interaction measure: GI of products in capillary samples measure: GI of products in continuous glucose monitors measure: Peak glucose capillary vs CGM measure: Time to peak glucose capillary vs CGM sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department for Health, University of Bath status: RECRUITING city: Bath zip: BA2 7AY country: United Kingdom name: Javier T Gonzalez, PhD role: CONTACT phone: +44 (0) 1225 38 phoneExt: 5125 email: j.t.gonzalez@bath.ac.uk lat: 51.3751 lon: -2.36172 hasResults: False

 nctId: NCT06333171 id: 00003872 briefTitle: 4-aminopyridine for Skin Wound Healing overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-09 date: 2028-03 date: 2024-03-27 date: 2024-03-27 name: John Elfar class: OTHER briefSummary: Many patients suffer from chronic non-healing wounds as well as acute wounds. There is a need to develop treatments to accelerate and improve healing of chronic and acute wounds. More research is needed to evaluate the role of 4-aminopyridine (4-AP), a promising new agent with an excellent safety profile, on wound healing. The investigational treatment will be used to evaluate the role of (4-AP) on the treatment of wounds to accelerate wound healing in healthy adults.

The purpose of this study is to evaluate the role of 4-AP on the treatment of wounds to accelerate healing.

The investigational treatment will be used to test the hypothesis that 4-AP can speed wound healing. conditions: Wounds conditions: Wound of Skin conditions: Wound Heal conditions: Wounds and Injuries studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a double-blind, randomized, placebo-controlled trial design. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Subjects in both aims will be assigned to Group A or Group B using a randomization scheme. Each study participant for each aim is randomly assigned to either treatment of placebo using permuted block randomization whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 68 type: ESTIMATED name: 4-Aminopyridine name: Placebo measure: Return of skin integrity and wound closure after skin punch biopsy measure: The effect of 4-AP on the hair number and growth at the skin punch biopsy site. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Arizona city: Tucson state: Arizona zip: 85724 country: United States name: Andrea Horne role: CONTACT phone: 520-626-6456 email: ahh@arizona.edu lat: 32.22174 lon: -110.92648 hasResults: False

 nctId: NCT06333158 id: AmWaRO Study briefTitle: Extracts of Amla, Walnut Leaf, Red Yeast Rice and Olive in Cardiovascular Prevention acronym: AmWaRO overallStatus: RECRUITING date: 2024-03-01 date: 2024-09 date: 2024-12 date: 2024-03-27 date: 2024-03-27 name: Nina Hermans class: OTHER name: University Hospital, Antwerp briefSummary: The aim of this study is to evaluate whether the use of a commercially available standardized combination preparation (Cholesfytol NG®), containing extracts of amla, walnut leaf, red yeast rice and olive, in individuals with hypercholesterolemia

1. Leads to a clinically relevant reduction of cholesterol levels, especially LDL,
2. Leads to a clinically relevant reduction of blood pressure on the short term,
3. Leads to a change in oxidative stress biomarkers.

Participants will be stratified by sex before randomization to one of the two treatments for 8 weeks:

* Cholesfytol NG: 500 mg Amla dry extract, 50 mg Walnut leaf dry extract, 33.6 mg Red yeast rice powder (equivalent to 1.45 mg monacolins), 25 mg Olive dry extract (equivalent to 5 mg of hydroxytyrosol) per day
* Placebo All treatments have an identical shape and color and should be used in the same way (oral intake; 3 capsules/day during dinner). No dietary instructions are given and participants are asked not to change their dietary habits, not to start other therapies (medication, supplements, slimming diets, extra physical activity, etc.) during their study period. Standardized questionnaires are used to obtain information on demographics, dietary habits and side effects. At baseline and after 8 weeks, 27 ml blood is drawn for various biological analyses, and blood pressure, BMI and waist circumference are measured. conditions: Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Cholesfytol NG name: Placebo measure: Change from baseline LDL cholesterol at 8 weeks measure: Frequency of side effects (+ their burden) as reported in the final questionnaire measure: Change from baseline Blood Pressure, Systolic at 8 weeks measure: Change from baseline Blood Pressure, diastolic at 8 weeks measure: Change from baseline total cholesterol level at 8 weeks measure: Change from baseline HDL cholesterol level at 8 weeks measure: Change from baseline non-HDL cholesterol level at 8 weeks measure: Change from baseline Remnant Cholesterol at 8 weeks measure: Change from baseline triglycerides level at 8 weeks measure: Change from baseline Apo A1 level at 8 weeks measure: Change from baseline Apo B level at 8 weeks measure: Change from baseline lipoprotein A (LP(a)) level at 8 weeks measure: Change from baseline OxLDL level at 8 weeks measure: Change from baseline malondialdehyde (MDA) level at 8 weeks measure: Change from baseline glutathion (GSH) level at 8 weeks measure: Change from baseline glucose level at 8 weeks measure: Change from baseline HbA1c level at 8 weeks measure: Change from baseline insuline level at 8 weeks measure: Change from baseline Body Mass Index (BMI) at 8 weeks measure: Change from baseline waist circumference at 8 weeks measure: Change from baseline hemoglobine level at 8 weeks measure: Change from baseline creatinine level at 8 weeks measure: Change from baseline hs-CRP level at 8 weeks measure: Change from baseline homocysteine level at 8 weeks measure: Change from baseline creatine kinase (CK) level at 8 weeks measure: Change from baseline C-peptide level at 8 weeks sex: ALL minimumAge: 18 Years maximumAge: 76 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UAntwerp, NatuRAPT status: RECRUITING city: Wilrijk state: Antwerp zip: 2610 country: Belgium name: Nina Hermans, Prof. role: CONTACT phone: 003232652732 email: nina.hermans@uantwerpen.be lat: 51.16734 lon: 4.39513 hasResults: False

 nctId: NCT06333145 id: EDRA briefTitle: ED90 of Remimazolam Anesthesia Induction in Drug-induced Sleep Endoscopy in Adults overallStatus: RECRUITING date: 2024-02-04 date: 2024-12-31 date: 2024-12-31 date: 2024-03-27 date: 2024-03-27 name: Tongji Hospital class: OTHER briefSummary: Exploring the ED90 of remimazolam in Drug-induced Sleep Endoscopy in adults at different BMI groups. conditions: Effect of Drug studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 110 type: ESTIMATED name: Remimazolam measure: Ramsey Sedation Scale measure: Time records measure: Use of drugs measure: Respiratory suppression incidence measure: Incidence of Treatment-Emergent Adverse Events measure: Incidence of PACU Adverse Reactions sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital status: RECRUITING city: Wuhan state: Hubei zip: 430000 country: China name: aijun xu, Dr. role: CONTACT phone: 027-83663173 email: ajxu@tjh.tjmu.edu.cn name: yuan Bi, Dr. role: CONTACT phone: 027-18972718216 email: 18972718216@163.com lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06333132 id: DiabEAT.it briefTitle: Deciphering the Role of Incretin Hormones in Weight Loss-induced Remission of Type 2 Diabetes (DIABeat) acronym: DiabEATit overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-09-01 date: 2026-02-01 date: 2024-03-27 date: 2024-03-27 name: Azienda Ospedaliero, Universitaria Pisana class: OTHER briefSummary: The goal of this mechanistic study is to investigate the role of incretin hormones on weight loss-induced type 2 diabetes remission. conditions: Obesity conditions: Diabetes Mellitus Type 2 in Obese studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Weight loss-induced Diabetes Remission measure: Number of participants with incretin effect's restoration after achieving weightloss-induced diabetes remission measure: Rate of sustained weightloss-induced diabetes remission assessed by 2 consecutive HbA1c <48mmol/mol within 6 months sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliero-Universitaria Pisana city: Pisa state: PI zip: 56127 country: Italy lat: 43.70853 lon: 10.4036 hasResults: False

 nctId: NCT06333119 id: 72867572-050.01.04-320 briefTitle: The Relationship Between Urinary Incontinence and Motor Symptoms overallStatus: COMPLETED date: 2023-09-01 date: 2024-01-31 date: 2024-02-15 date: 2024-03-27 date: 2024-03-27 name: Pinar Yasar class: OTHER briefSummary: There is no study in the literature examining the relationship between urinary incontinence and motor symptoms in individuals with stroke. The aim of this study is to determine the relationship between urinary incontinence and spasticity, balance and walking, which negatively affect quality of life and functional performance after stroke. conditions: Stroke conditions: Urinary Incontinence conditions: Motor Skills Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 46 type: ACTUAL name: modified rankin scale measure: relationship with between urinary incontinence and motor symptoms sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Suleyman Demirel University city: Isparta country: Turkey lat: 37.76444 lon: 30.55222 hasResults: False

 nctId: NCT06333106 id: FICUS - 2024/16FEV/077 briefTitle: PoCUS Diagnostic Accuracy for Fecal Impaction in the Emergency Department: A Prospective Study overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-27 date: 2024-04-29 name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain class: OTHER name: Université de Liège name: Grand Hôpital de Charleroi name: Clinique Saint-Jean, Bruxelles name: Clinique Saint Pierre Ottignies briefSummary: Many medical and paramedical specialties regularly use point-of-care ultrasound (PoCUS) in clinical practice. The diagnosis of fecal impaction is quite common in the elderly living in nursing homes with a prevalence of 47.3%. Fecal impaction remains a major source of morbidity, while its etiology is often multifactorial and its diagnosis challenging. Current recommendations for the diagnosis of fecal impaction support the use of plain abdominal x-rays. PoCUS is a non-irradiating procedure and a clinical diagnostic tool that can be used in a variety of ways during abdominal examinations. Most scientific societies encourage the use of PoCUS to respond to a specific clinical question rather than to provide a diagnosis, which is usually confirmed by conventional ultrasound. However, the combination of physical examination and PoCUS may improve the diagnostic approach. This multicentric prospective study protocol aims to evaluate the diagnostic accuracy of PoCUS in patients aged 75 years or older with suspected fecal impaction in the emergency department compared with plain abdominal x-ray (or abdominal CT scan if required as part of the emergency department investigations). conditions: Fecal Impaction of Colon studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 247 type: ESTIMATED name: POCUS diagnostic value measure: Evaluation of the diagnostic value of clinical ultrasound in the diagnosis of fecal impaction in the emergency room measure: Influence of BMI on the diagnosis of fecal impaction at PoCUS measure: Influence of bladder repletion on the diagnosis of fecal impaction using PoCUS measure: Influence of patient echogenicity on the diagnosis of fecal impaction using PoCUS sex: ALL minimumAge: 75 Years maximumAge: 130 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06333093 id: NL82178.018.22 briefTitle: Duodenal tIssue ResEction aCquisiTion (DIRECT) Study acronym: DIRECT overallStatus: RECRUITING date: 2023-01-10 date: 2024-06-01 date: 2024-06-01 date: 2024-03-27 date: 2024-03-27 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER briefSummary: To evaluate the quality of cold snare resection specimens of duodenal mucosa tissue in patients undergoing an upper gastrointestinal interventional endoscopy in order to improve the processing of histological samples and its assessment in general and for future duodenal ablation studies. conditions: Duodenum Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: Cold snare measure: Acquiring larger pieces of tissue from the duodenum measure: Histopatholocial assessment of larger pieces of tissue from the duodenum measure: Checking if the tissue is of good quality enough for single cell RNA sequencing sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC status: RECRUITING city: Amsterdam state: North-Holland zip: 1105 AZ country: Netherlands name: Celine BE Busch, MD role: CONTACT phone: +31621357593 email: diabetes-onderzoek@amsterdamumc.nl name: Jacques JG Bergman, MD PhD role: PRINCIPAL_INVESTIGATOR name: Celine BE Busch, MD role: SUB_INVESTIGATOR lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06333080 id: N-20220017 briefTitle: The Effect of Adherence to Oral Semaglutide on Glycaemic Control in People With Type 2 Diabetes Treated With Metformin acronym: DIACRON overallStatus: RECRUITING date: 2024-05-01 date: 2025-03 date: 2025-03 date: 2024-03-27 date: 2024-03-27 name: Aalborg University Hospital class: OTHER briefSummary: The objective of the trial is to investigate the effect of adherence to oral semaglutide dosing instructions on glycaemic control in people with type 2 diabetes, which are dysregulated on metformin and naïve to second line antidiabetic treatment. conditions: Diabetes Mellitus, Type 2 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED measure: Time-in-Range (TIR) measure: Pre-dose Fasting measure: Post-dose Fasting measure: Occurrence of nausea or vomiting measure: Water Intake at Dosing Time measure: Treatment-Related Impact Measure for Diabetes (TRIM-D) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Steno Diabetes Center North Denmark status: RECRUITING city: Aalborg zip: 9000 country: Denmark name: Mette Pilegaard Rasmussen, BSc role: CONTACT phone: 00 45 30 36 46 84 email: mpr@rn.dk name: Peter Vestergaard, MD role: PRINCIPAL_INVESTIGATOR name: Nynne S Holdt-Caspersen, MSc role: SUB_INVESTIGATOR lat: 57.048 lon: 9.9187 hasResults: False

 nctId: NCT06333067 id: Sofwave21 briefTitle: Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators overallStatus: RECRUITING date: 2023-10-11 date: 2024-10-01 date: 2024-11-01 date: 2024-03-27 date: 2024-03-27 name: Sofwave Medical LTD class: INDUSTRY briefSummary: Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation. conditions: Lax Skin studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Sofwave measure: Primary Outcome Measure sex: ALL minimumAge: 35 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Costal Skin & Eye Institute status: RECRUITING city: La Mesa state: California zip: 91942 country: United States name: Christopher V.Crosby, MD role: CONTACT email: research@coastalskineye.com name: Christopher V.Crosby, MD role: PRINCIPAL_INVESTIGATOR lat: 32.76783 lon: -117.02308 facility: Skin Wellness Dermatology Associates status: RECRUITING city: Durham state: North Carolina zip: 27713 country: United States name: Talasia Smith role: CONTACT phone: 919-294-9440 email: cst@skinwellnessdermatology.com name: Brooke Jackson, MD role: PRINCIPAL_INVESTIGATOR lat: 35.99403 lon: -78.89862 hasResults: False

 nctId: NCT06333054 id: NCLIN0091/ 14ct/mp37li briefTitle: Safety and Efficacy of a Head Lice Shampoo overallStatus: COMPLETED date: 2014-10-13 date: 2015-06-08 date: 2015-06-08 date: 2024-03-27 date: 2024-03-27 name: Oystershell NV class: INDUSTRY briefSummary: This study is designed to compare the effectiveness and safety of test head lice shampoo (Test product) versus Goldgeist® Forte (reference product) following two applications. conditions: Head Lice studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 109 type: ACTUAL name: Pyrethrum Extract name: Silcap Shampoo measure: Cure Rate superior to 70% for the test product measure: Cure Rate superior to 70% for the reference product measure: Superior cure rate to the reference measure: Non-inferiority rate to the reference measure: Local tolerability measure: Global tolerability measure: Skin irritation assessment measure: Eye irritation assessment measure: Esthetical effect of the anti-lice products measure: Adverse Events (AEs) measure: Severity of the lice infestation sex: ALL minimumAge: 1 Year stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CardioSec Clinical Research GmbH city: Erfurt zip: 99084 country: Germany lat: 50.9787 lon: 11.03283 hasResults: False

 nctId: NCT06333041 id: 32977-01-00 briefTitle: Study of Cannabidiol in Sanfilippo Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-01 date: 2027-05 date: 2024-03-27 date: 2024-04-19 name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center class: OTHER briefSummary: The goal of this clinical trial is to test cannabidiol in Sanfilippo syndrome. The main questions it aims to answer are: 1) determine the safety of cannabidiol in Sanfilippo syndrome, and 2) explore the efficacy of cannabidiol in treating the neurobehavioral symptoms and functional outcomes of Sanfilippo syndrome.

Each participant's caregiver will be asked to complete surveys related to the participant's behavior, mood, sleep, stooling, pain, and caregiver stress intermittently throughout the study. All participants will be enrolled into one of two cohorts based on enrollment order:

1. Sentinel Safety Cohort (first 5 participants) - all participants treated with Epidiolex (cannabidiol)
2. Controlled Cohort (next 30 participants) - participants randomized 1:1 (equal chance) to start treatment with Epidiolex (cannabidiol) or placebo for 16 weeks, followed by an 8-week washout period (no treatment). Participants then switch to the opposite treatment group for 16 weeks followed by all participants treated for 52 weeks with Epidiolex (cannabidiol). conditions: Sanfilippo Syndrome conditions: Mucopolysaccharidosis III studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Double-blind, placebo-controlled, cross-over study primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 35 type: ESTIMATED name: Epidiolex name: Placebo measure: Sanfilippo Behavior Rating Scale (SBRS)- mood/anger/aggression score sex: ALL minimumAge: 4 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center city: Torrance state: California zip: 90502 country: United States name: Cristi Williams role: CONTACT email: cristi.williams@lundquist.org name: Lynda Polgreen, MD, MS role: PRINCIPAL_INVESTIGATOR lat: 33.83585 lon: -118.34063 hasResults: False

 nctId: NCT06333028 id: 938 briefTitle: A Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-09 date: 2024-03-27 date: 2024-04-29 name: Bausch & Lomb Incorporated class: INDUSTRY briefSummary: A Study to Evaluate the enVista® Aspire (EA) intraocular lens in Subjects Undergoing Cataract Extraction conditions: Cataract studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: enVista Aspire EA IOLs measure: Mean binocular BCDVA (logMAR) at Visit 1 sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SITE 104 city: Dover state: New Jersey zip: 07801 country: United States lat: 40.88399 lon: -74.5621 facility: Site 105 city: Woodland Park state: New Jersey zip: 07424 country: United States lat: 40.88982 lon: -74.19487 facility: Site 103 city: Garden City state: New York zip: 11530 country: United States lat: 40.72677 lon: -73.6343 facility: Site 106 city: Charleston state: South Carolina zip: 29407 country: United States lat: 32.77657 lon: -79.93092 facility: Site 101 city: Sugar Land state: Texas zip: 77478 country: United States lat: 29.61968 lon: -95.63495 facility: Site 102 city: Mount Pleasant state: Wisconsin zip: 53405 country: United States lat: 42.69743 lon: -87.85577 hasResults: False

 nctId: NCT06333015 id: 924 briefTitle: Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-10 date: 2025-10 date: 2024-03-27 date: 2024-04-29 name: Bausch & Lomb Incorporated class: INDUSTRY briefSummary: This research study is evaluating the safety and efficacy (performance) of the Bausch + Lomb enVista Beyond Hydrophobic Acrylic Extended Depth of Focus Intraocular Lens (IOL) in subjects who receive this IOL in both eyes. conditions: Cataract studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Approximately 224 subjects (448 eyes) will be enrolled in this study with plans to bilaterally implant approximately 112 subjects with each of the test and control IOLs. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Subjects and designated postoperative evaluator(s) will be masked to the IOLs assigned. The Investigator implanting the IOL and designated site personnel will be unmasked to the treatment assignment for a subject. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 224 type: ESTIMATED name: enVista EY Beyond IOL name: TECNIS 1-Piece monofocal IOL measure: Mean Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4. measure: Median Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4. measure: Negative lens induced distance-corrected Depth of focus (D) at 0.20 logMAR of first implanted eyes at Post-Operative Visit 4. measure: Mean monocular best-corrected distance visual acuity (BCDVA) (logMAR) of first implanted eyes at Post-Operative Visit 4. measure: Rates with postoperative monocular BCDVA of 20/40 (0.30 logMAR) or better of first implanted eyes at Post-Operative Visit 4. measure: Mean monocular photopic distance-corrected near visual acuity (DCNVA) of first implanted eyes at Post-Operative Visit 4. sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Site 108 city: Northridge state: California zip: 91325 country: United States lat: 34.22834 lon: -118.53675 facility: Site 107 city: Bloomington state: Minnesota zip: 55420 country: United States lat: 44.8408 lon: -93.29828 facility: Site 101 city: Omaha state: Nebraska zip: 68137 country: United States lat: 41.25626 lon: -95.94043 facility: Site 109 city: Las Vegas state: Nevada zip: 89145 country: United States lat: 36.17497 lon: -115.13722 facility: Site 102 city: Brecksville state: Ohio zip: 44141 country: United States lat: 41.31978 lon: -81.62679 facility: Site 105 city: North Charleston state: South Carolina zip: 29406 country: United States lat: 32.85462 lon: -79.97481 facility: Site 106 city: Sioux Falls state: South Dakota zip: 57108 country: United States lat: 43.54997 lon: -96.70033 facility: Site 103 city: Dallas state: Texas zip: 75243 country: United States lat: 32.78306 lon: -96.80667 facility: Site 111 city: Mount Pleasant state: Wisconsin zip: 53405 country: United States lat: 42.69743 lon: -87.85577 facility: Site 110 city: Calgary state: Alberta zip: T2N 1N4 country: Canada lat: 51.05011 lon: -114.08529 facility: Site 104 city: Montréal state: Quebec zip: H1V 1G5 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06333002 id: PI24/00325 briefTitle: Machine Learning Model to Predict Outcome and Duration of Mechanical Ventilation in Acute Hypoxemic Respiratory Failure acronym: MEMORIAL overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-19 date: 2026-05-30 date: 2026-05-30 date: 2024-03-27 date: 2024-03-27 name: Dr. Negrin University Hospital class: OTHER briefSummary: Acute hypoxemic respiratory failure (AHRF) is the most common cause of admission in the intensive care units (UCIs) worldwide. We will assess the value of machine learning (ML) techniques for early prediction of ICU death and prolonged duration (\>7 days) of mechanical ventilation (MV) in 1,241 patients enrolled in the PANDORA (Prevalence AND Outcome of acute Respiratory fAilure) Study in Spain. The study was registered with ClinicalTrials.gov (NCT03145974). Our aim is to evaluate the minimum number of variables models using logistic regression and four supervised ML algorithms: Random Forest, Extreme Gradient Boosting, Support Vector Machine and Multilayer Perceptron. conditions: Acute Hypoxemic Respiratory Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1241 type: ESTIMATED name: machine learning analysis measure: ICU mortality measure: MV duration sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital General Universitario de Ciudad Real city: Ciudad Real zip: 13005 country: Spain lat: 38.98626 lon: -3.92907 facility: Hospital Virgen de La Luz city: Cuenca zip: 16002 country: Spain lat: 40.06667 lon: -2.13333 facility: Hospital Universitario La Paz city: Madrid zip: 28046 country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Puerta de Hierro city: Madrid zip: 28222 country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Virgen de Arrixaca city: Murcia zip: 3012 country: Spain lat: 37.98704 lon: -1.13004 facility: Hospital Universitario NS de Candelaria city: Santa Cruz De Tenerife zip: 38010 country: Spain lat: 28.46824 lon: -16.25462 facility: Hospital Cinico de Valencia city: Valencia zip: 46010 country: Spain lat: 39.46975 lon: -0.37739 facility: Hospital Universitario Rio Hortega city: Valladolid zip: 47012 country: Spain lat: 41.65518 lon: -4.72372 hasResults: False

 nctId: NCT06332989 id: N22.129 briefTitle: Stroke Triage Optimization by Ambulance Paramedics in the Pre-hospital Setting acronym: STROKE-APP overallStatus: RECRUITING date: 2024-02-01 date: 2027-02-01 date: 2027-02-01 date: 2024-03-27 date: 2024-03-27 name: Leiden University Medical Center class: OTHER name: Alrijne Ziekenhuis Leiderdorp name: Groene Hart Ziekenhuis name: Medical Center Haaglanden name: HagaZiekenhuis name: Reinier de Graaf Groep name: Regionale Ambulance Voorziening Hollands Midden briefSummary: There are everal scales designed to help ambulance paramedics to identify a patient with a stroke and activate a stroke code. These scales were never tested in the field in a large unselected patient sample. We aim to perform an in-the field head tot head comparison of all published stroke scales designed to be used by ambulance paramedics conditions: Stroke, Acute conditions: Pre-hospital Triage conditions: Stroke Treatment conditions: Stroke Code studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED name: stroke-APP measure: final diagnosis measure: treated with reperfusion therapy measure: additional investigations sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Leiden University medical center status: RECRUITING city: Leiden country: Netherlands name: Nyika D Kruyt, MD. PhD role: CONTACT phone: 0031-715262139 email: n.d.kruyt@lumc.nl lat: 52.15833 lon: 4.49306 hasResults: False

 nctId: NCT06332976 id: IEO 1521 briefTitle: PrefeRences And ChemoTherapy In Breast Cancer patiEnts acronym: PRACTICE overallStatus: RECRUITING date: 2021-06-04 date: 2024-12-31 date: 2024-12-31 date: 2024-03-27 date: 2024-03-27 name: European Institute of Oncology class: OTHER briefSummary: The aim of the present study is to ask women treated with adjuvant or neoadjuvant chemotherapy for breast cancer what survival benefit would justify the treatment.

The benefit should be evaluated in terms of Survival rate trade off and Survival time trade off value. The analyses will be conducted into three different groups of patients to value the survival benefit expected:

1. before to start the chemotherapy
2. during chemotherapy
3. after the end of chemotherapy conditions: Female Breast Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 450 type: ESTIMATED name: Completion of questionnaires measure: Percentage of risk reduction needed to consider adjuvant or neoadjuvant chemotherapy worthwhile measure: Prolonged survival time gain needed to consider CT worthwhile measure: Behavior assessment measure: Reaction to uncertain situations assessment measure: Regret and disappointment assessment sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan zip: 20141 country: Italy name: Emilia Montagna, MD role: CONTACT phone: +390257489970 email: emilia.montagna@ieo.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06332963 id: 2023-007 briefTitle: Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-06 date: 2028-12 date: 2024-03-27 date: 2024-03-27 name: Laureate Institute for Brain Research, Inc. class: OTHER briefSummary: The proposed study utilizes a randomized experimental therapeutics design to test a mechanistic framework linking interoceptive processing and disturbed body image, with the purpose of informing the development of future therapies for body image dissatisfaction in anorexia nervosa (AN). A sample of 102 participants will be recruited from the Laureate Eating Disorder Program (LEDP). After being randomized, participants will all receive a one-hour session of acceptance- and mindfulness-based training with a therapist (the introduction session). They will then receive either the interoceptively focused treatment (IFT) or exteroceptively focused treatment (EFT) condition based on randomization. In the IFT condition participants will engage in floatation-REST (Reduced Environmental Stimulation Therapy) while practicing acceptance and mindfulness-based principles. The EFT condition is an exteroceptive intervention in which participants will be asked to view pre-recorded videos of acceptance and mindfulness-based skills to aid in the practice of these skills. Each condition will consist of one introduction session and three experimental sessions. All participants will then return for follow-up measures. Assessed outcomes will include acute changes in body image disturbance (BID) and interoception. Further, longitudinal intervention effects on self-reported eating disorder symptoms, body image dissatisfaction, and interoception; behavioral measures of interoception and body image dissatisfaction; and resting state and interoceptive functioning during functional magnetic resonance imaging (fMRI) will be explored. conditions: Anorexia Nervosa conditions: Body Image Disturbance conditions: Interoception studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Equal groups parallel randomized clinical trial primaryPurpose: TREATMENT masking: NONE count: 102 type: ESTIMATED name: Floatation-REST name: IFT name: EFT measure: Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS) measure: Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS) measure: Cognitive/affective body image on the Body Image State Scale (BISS) measure: Body image dissatisfaction on the Somatomap3D measure: Appearance evaluation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Appearance Evaluation Subscale (range 7 to 35, higher scores indicate more satisfaction with appearance) measure: Appearance orientation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Appearance Orientation Subscale (range 7 to 35, higher scores indicate more satisfaction with appearance) measure: Body image satisfaction on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Body Areas Satisfaction measure: Overweight preoccupation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Overweight preoccupation scale measure: Noticing on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) measure: Not distracting on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) measure: Not worrying on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) measure: Attention regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) measure: Emotional awareness on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) measure: Self-regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) measure: Trust on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) measure: Interoceptive attention on the Interoceptive Attention Scale (IATS) measure: Cardiac interoceptive accuracy on the Heartbeat Tapping Task measure: Cardiac interoceptive intensity on the Heartbeat Tapping Task measure: Interoceptive intensity during experimental conditions measure: Perceived respiratory interoceptive intensity on the Breath Hold Task measure: Body image distortion on the Aperture Task measure: Body image distortion on the String task sex: FEMALE minimumAge: 15 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06332950 id: MA-SCLC-II-015 briefTitle: Safety and Efficacy of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in ES-SCLC Pre-treated With Immunotherapy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-04-01 date: 2027-04-01 date: 2024-03-27 date: 2024-03-27 name: Baohui Han class: OTHER briefSummary: This is an open-label, randomized, multi-cohort, multi-center, phase Ib/II study to evaluate the safety and efficacy of Adebrelimab plus Irinotecan Liposome (II) with or without Famitinib in patients with extensive-stage small cell lung cancer (ES-SCLC) pre-treated with immune checkpoint inhibitor(s). conditions: Extensive-stage Small-cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Adebrelimab, Irinotecan Liposome (II) name: Adebrelimab, Irinotecan Liposome (II), Famitinib measure: 6-month progression-free survival measure: Safety measure: Objective response rate measure: Progression-free survival measure: Overall survival measure: Disease control rate measure: Duration of response sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital city: Shanghai country: China name: Baohui Han, M.D role: CONTACT email: 18930858216@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06332937 id: H-2102-079-1197 briefTitle: Breast Reconstruction overallStatus: ACTIVE_NOT_RECRUITING date: 2021-02-22 date: 2023-12-15 date: 2024-12-31 date: 2024-03-27 date: 2024-03-27 name: Seoul National University Hospital class: OTHER briefSummary: Complications following postmastectomy breast reconstruction can compromise surgical outcomes and lead to significant morbidity. The aim of this study was to determine factors associated with complication following two-stage implant-based reconstruction conditions: Breast Implant; Complications studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 5000 type: ESTIMATED name: postmastectomy breast reconstruction measure: Infection sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital city: Seoul zip: 03080 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06332924 id: 2023/19 briefTitle: Primipara Pregnant Women and Motivational Interview overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-07-01 date: 2024-08-01 date: 2024-03-27 date: 2024-03-27 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: The first birth is the most important moment a woman experiences in her life as she embarks on her motherhood journey. Waiting for the birth of a new life can be very exciting for mothers. Positive birth is an approach that asks the woman to approach her birth story from a positive perspective and to have a stronger, more impressive and positive birth experience. Primipara pregnant women especially benefit from and need this positive birth approach. Motivational interviews are interviews conducted to support positive births and to help women develop a positive attitude towards their birth experiences.

This planned study was planned as a randomized controlled trial with pre-test and post-test measurements, with the aim of determining the level of traumatic birth perception in primipara women who were given or not given training and examining the effects of positive birth motivational education by taking into account the need for education with numerical data. conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In the project, it was calculated that the experimental and control groups should have at least 30 observations each, and the sample of the study was calculated as 60 pregnant women. It was aimed to interview a total of 60 pregnant women, 30 in the control group and 30 in the experimental group. primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: motivational discussion group measure: Primipara Pregnant Women and Traumatic Birth sex: FEMALE minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06332911 id: RO-231129 briefTitle: Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair acronym: TEVAR overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-08-30 date: 2026-08-30 date: 2024-03-27 date: 2024-03-27 name: Rede Optimus Hospitalar SA class: NETWORK name: Shockwave Medical, Inc. briefSummary: Shockwave TEVAR is a nonrandomized, prospective, international, multi-center, PMCF, obervational study.

The aim of this study is to evaluate the outcomes of the Shockwave™ Peripheral Intravascular Lithotripsy Balloon (Shockwave Medical Inc.) in the routine treatment of hostile iliac accesses during TEVAR and F/BEVAR. conditions: Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture conditions: Abdominal Aortic Aneurysm Without Rupture conditions: Thoracic Aortic Aneurysm Without Rupture studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+ measure: Efficacy: Technical success - defined as intention-to-treat basis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06332898 id: AG-01-0324 briefTitle: The Effects of a Nutritional Supplement on Nutrient Status and Quality of Life overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2024-10-31 date: 2025-02-04 date: 2024-03-27 date: 2024-04-01 name: Athletic Greens International class: INDUSTRY name: Citruslabs briefSummary: This study is a randomized, double-blind, placebo-controlled study of N=120 apparently healthy men and women. The purpose of this study is to assess the effect of a novel dietary supplement on blood markers of nutrient status, gut microbiome, and overall quality of life. conditions: Nutrition, Healthy conditions: Gastrointestinal Microbiome conditions: Healthy Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, Double-Blind, Placebo Controlled Design primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: AG1 - Nutritional Supplement name: Placebo measure: Homocysteine measure: Vitamin B12 measure: Folate measure: Red Blood Cell Folate measure: Zinc measure: Vitamin C measure: Gut Microbiome measure: Dietary habits measure: Gastrointestinal Health measure: Fatigue & energy measure: Well-being measure: Complete Metabolic Blood Panel measure: Complete Blood Count sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06332885 id: 630-2001-01 briefTitle: Zephyr Valve Japan Post-Marketing Surveillance overallStatus: RECRUITING date: 2024-03-12 date: 2027-03-31 date: 2028-03-31 date: 2024-03-27 date: 2024-04-19 name: Pulmonx Corporation class: INDUSTRY briefSummary: This is a multicenter, prospective, observational surveillance enrolling 140 consecutive patients with severe emphysema who are candidates for bronchoscopic lung volume reduction using Zephyr Endobronchial Valve at up to 20 centers across Japan and followed for 12 months. conditions: Emphysema conditions: COPD conditions: Severe Emphysema studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 140 type: ESTIMATED name: Zephyr Endobronchial Valve measure: Incidence rate of pneumothorax at 45-days post-Zephyr Valve index procedure. measure: Forced Expiratory Volume in 1 second (FEV1) measure: Residual Volume (RV) measure: Treated lobe volume reduction (TLVR) measure: Six-Minute Walk Distance (6MWD) measure: Modified Medical Research Council Dyspnea (mMRC) Scale score measure: St. George's Respiratory Questionnaire (SGRQ) Total Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gifu Prefectural Medical Center status: RECRUITING city: Gifu country: Japan name: Takahiro Masami role: CONTACT email: chiken-center.4289@gifu-hp.jp name: Fumihiro Asano, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 35.42291 lon: 136.76039 facility: Kanagawa Cardio Chest Center status: RECRUITING city: Kanagawa country: Japan name: Takashi Niwa, MD role: CONTACT email: wanikko0714@gmail.com name: Takashi Niwa, MD role: PRINCIPAL_INVESTIGATOR lat: 37.58333 lon: 139.91667 facility: Kanazawa University Hospital status: RECRUITING city: Kanazawa country: Japan name: Satoshi Watanabe, MD role: CONTACT email: swatanabe@staff.kanazawa-u.ac.jp name: Satoshi Watanabe, MD role: PRINCIPAL_INVESTIGATOR lat: 36.6 lon: 136.61667 facility: St Marianna University Hospital status: RECRUITING city: Kawasaki country: Japan name: Masamichi Mineshita, MD role: CONTACT email: m-mine@marianna-u.ac.jp name: Masamichi Mineshita, MD role: PRINCIPAL_INVESTIGATOR lat: 35.52056 lon: 139.71722 facility: Nagasaki University Hospital status: RECRUITING city: Nagasaki country: Japan name: Keitaro Matsumoto, MD role: CONTACT email: kmatsumo@nagasaki-u.ac.jp name: Keitaro Matsumoto, MD role: PRINCIPAL_INVESTIGATOR lat: 32.75 lon: 129.88333 facility: Nagoya Medical Center status: RECRUITING city: Nagoya country: Japan name: Masahide Oki, MD role: CONTACT email: masahideo@gmail.com name: Masahide Oki, MD role: PRINCIPAL_INVESTIGATOR lat: 35.18147 lon: 136.90641 facility: Okayama Medical Center status: RECRUITING city: Okayama country: Japan name: Yanagihara role: CONTACT email: okmc-iec@nifty.com name: Ken Sato, MD role: PRINCIPAL_INVESTIGATOR lat: 34.65 lon: 133.93333 facility: Kinki Chuo Chest Medical Center status: RECRUITING city: Osaka country: Japan name: Akihiro Tamiya, MD role: CONTACT email: tamiya.akihiro.tz@mail.hosp.go.jp name: Akihiro Tamiya, MD role: PRINCIPAL_INVESTIGATOR lat: 34.69374 lon: 135.50218 facility: Hokkaido University Hospital status: RECRUITING city: Sapporo country: Japan name: Naofumi Shinagawa, MD role: CONTACT email: naop.shinagawa@nifty.ne.jp name: Naofumi Shinagawa, MD role: PRINCIPAL_INVESTIGATOR lat: 43.06667 lon: 141.35 facility: Tohoku University Hospital status: RECRUITING city: Sendai country: Japan name: Hirotsugu Notsuda, MD role: CONTACT email: hirotsugu.notsuda.c4@tohoku.ac.jp name: Hirotsugu Notsuda, MD role: PRINCIPAL_INVESTIGATOR lat: 38.26667 lon: 140.86667 facility: Shiga University Hospital status: RECRUITING city: Shiga country: Japan name: Yasuki Uchida, MD role: CONTACT email: uchiy@belle.shiga-med.ac.jp name: Yasuki Uchida, MD role: PRINCIPAL_INVESTIGATOR facility: Tokyo National Hospital status: RECRUITING city: Tokyo country: Japan name: Hiroyuki Tashimo, MD role: CONTACT name: Hiroyuki Tashimo, MD role: PRINCIPAL_INVESTIGATOR lat: 35.6895 lon: 139.69171 facility: Fujita Health University Hospital status: RECRUITING city: Toyoake country: Japan name: Risako Koshiyama role: CONTACT email: gcpjim@fujita-hu.ac.jp name: Kazuyoshi Imaizumi, MD role: PRINCIPAL_INVESTIGATOR lat: 35.038 lon: 136.99931 facility: Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology) status: NOT_YET_RECRUITING city: Utsunomiya country: Japan name: Yasuo Shimizu, MD role: CONTACT email: yasuo-s@dokkyomed.ac.jp name: Yasuo Shimizu, MD role: PRINCIPAL_INVESTIGATOR lat: 36.56667 lon: 139.88333 facility: Dokkyo University Hospital status: RECRUITING city: Utsunomiya country: Japan name: Masayuki Chida, MD role: CONTACT email: chidaths@dokkyomed.ac.jp name: Masayuki Chida, MD role: PRINCIPAL_INVESTIGATOR lat: 36.56667 lon: 139.88333 hasResults: False

 nctId: NCT06332872 id: M046q/66 briefTitle: Comparison Effectiveness of Oral Ivermectin , 1% Permethrin Shampoo and 4% Dimeticone Liquid Gel in the Treatment of Pediculosis Capitis Among School Children in Chachoengsao Province, Thailand overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-15 date: 2024-03-18 date: 2024-05 date: 2024-03-27 date: 2024-03-27 name: Phramongkutklao College of Medicine and Hospital class: OTHER briefSummary: The goal of this clinical trial is to Comparison effectiveness of Oral ivermectin , 1% Permethrin shampoo and 4% Dimeticone liquid gel in the treatment of Pediculosis capitis, to assess the prevalence of lice and associated risk factors between severity groups by using questionnaire-based surveys and diagnostic tests among school children in Baan Nayao, Chachoengsao Province, Thailand.

The main questions it aims to answer are

* What is more effective between Oral ivermectin , 1% Permethrin shampoo and 4%Dimeticone liquid gel in the treatment of Pediculosis capitis in school children in Baan Nayao, Chachoengsao Province, Thailand?
* What is Prevalence and risk factors of being infected with in head lice in school and community?
* What is Side effects of Oral ivermectin , 1% Permethrin shampoo and 4%Dimeticone liquid gel?

Participants will receive three different drugs are

* oral ivermectin
* 4% Dimeticone liquid gel
* 1% Permethrin shampoo

Participants voluntarily received oral ivermectin as per medical prescription, with treatment outcomes, side effects, and satisfaction levels monitored following two treatment cycles. Those exhibiting persistent lice infestations were subsequently treated with 1% permethrin shampoo, the standard treatment, while alternatives were provided for individuals allergic to permethrin. These findings will contribute to formulating tailored, effective, and safe treatment regimens for future patients. conditions: Pediculus Capitis Infestation conditions: Permethrin Adverse Reaction conditions: Dimethicone Adverse Reaction conditions: Permethrin Allergy conditions: Dimethicone Allergy conditions: Ivermectin conditions: School-age Children studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 117 type: ESTIMATED name: Oral Ivermectin name: 4% dimenticone liquid gel measure: Comparison effectiveness of Oral ivermectin , 1% Permethrin shampoo and 4% Dimeticone liquid gel in the treatment of Pediculosis capitis measure: Prevalence of head louse infestation among school children in Chachoengsao Province, Thailand measure: Side effects of Oral ivermectin , 1% Permethrin shampoo and 4%Dimeticone liquid gel measure: The association factor of head lice infestation among school children in Chachoengsao Province, Thailand sex: ALL minimumAge: 6 Years maximumAge: 13 Years stdAges: CHILD facility: Phramongkutklao college of medicine city: Bangkok country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06332859 id: FOR-0022 briefTitle: Effectiveness of a Resilience-Based Rehabilitation Program for Patients With Coronary Heart Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-10-14 date: 2026-10-14 date: 2024-03-27 date: 2024-03-27 name: Pensionsversicherungsanstalt class: OTHER briefSummary: To handle daily life challenges, one needs to be psychologically resilient. It plays a crucial role in disease development, prognosis, as well as social, occupational, and community participation. Cardiovascular diseases cause physical and psychological stress, which can be linked to individual resilience and the development of such diseases. Stress can trigger TakoTsubo cardiomyopathy and acute coronary events. Individuals who have experienced TakoTsubo cardiomyopathy or an acute coronary event often feel stressed due to emotional or physical triggers. These triggers may include job loss or illness. In medical rehabilitation, therapists consider the individual circumstances of their patients when planning therapy. It may be important to add a special focus on psychological care, including building resilience, which could greatly benefit these individuals. Therefore, the study aims to investigate whether resilience training, as part of an inpatient multidisciplinary rehabilitation program, affects the individual resilience of rehabilitants with TakoTsubo cardiomyopathy or those who have experienced an acute coronary event. conditions: Takotsubo Cardiomyopathy conditions: Acute Coronary Syndrome conditions: Psychological Resilience studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: Resilience training measure: Resilience scale-13 (RS-13) measure: Brief Resilience scale - German Version (BRS) measure: European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) measure: Patient Health Questionnaire-4 (PHQ-4) measure: Maximal incremental exercise test measure: Work ability index (WAI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06332846 id: KB-0012/06/10 briefTitle: Oral Health in Patients Hospitalized Because of Ischemic Stroke overallStatus: COMPLETED date: 2019-10-10 date: 2021-11-15 date: 2023-12-10 date: 2024-03-27 date: 2024-03-27 name: Pomeranian Medical University Szczecin class: OTHER briefSummary: Maintaining good oral health is essential for general health and quality of life. Results of many anal-yses showed that stroke patients had poorer oral condition and worse periodontal status than control population. The aim of the study was to carry out a clinical observation concerning condition of oral health in stroke patients and healthy population.

The oral health was assessed in patients with stroke and in (control group). The following elements were assessed: missing teeth, the presence of active caries foci, the presence of existing fillings and prosthetic restorations. To assess oral hygiene API (Approximal Plaque Index) was used. As part of periodontal examina-tion, the following were assessed: the presence of dental deposits, the depth of the existing periodontal pockets, tooth mobility according to Hall and Sulcus Bleeding Index during probing (SBI). conditions: Oral Disease conditions: Stroke, Ischemic studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 118 type: ACTUAL name: oral examination name: oral examination measure: Oral health status measure: Oral hygiene assessment measure: Periodontal status- periodontal pockets measure: Periodontal status-tooth mobility measure: Periodontal status- bleeding sex: ALL minimumAge: 45 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pomeranian Medical University in Szczecin city: Szczecin zip: 70-111 country: Poland lat: 53.42894 lon: 14.55302 hasResults: False

 nctId: NCT06332833 id: 235 briefTitle: Availability of Venous Conduits in Patients With Varicose Veins for Arterial Bypass Surgery overallStatus: RECRUITING date: 2023-12-01 date: 2024-05-31 date: 2024-05-31 date: 2024-03-27 date: 2024-03-27 name: Pirogov Russian National Research Medical University class: OTHER briefSummary: Patients with PAD having superficial femoral artery (SFA) occlusion were consecutively enrolled. Demographic data and medical history were taken. Physical examination and duplex ultrasound were performed. conditions: Varicose Veins conditions: Peripheral Arterial Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED measure: availability of saphenous trunks as possible grafts measure: presence of varicose veins measure: type of previous invasive procedure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Veronika Golovina status: RECRUITING city: Moscow state: Pirogov Russian National Research Medical University zip: 109044 country: Russian Federation name: Veronika Golovina, MD, PHD role: CONTACT phone: +79776051708 email: nikuskin@inbox.ru lat: 55.75222 lon: 37.61556 hasResults: False

 nctId: NCT06332820 id: 202401226RINB briefTitle: In Patients With Obstructive Airway Disease, Investigate the Effects of Different Breathing Strategies and Pedaling Rates on the Physiological Response to Bicycle Exercise overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-20 date: 2030-12-31 date: 2030-12-31 date: 2024-03-27 date: 2024-04-09 name: National Taiwan University Hospital class: OTHER briefSummary: The definition of obstructive airway disease is a ratio of the forced expiratory volume in one second (FEV1) to the forced vital capacity (FVC) of less than 0.7, which includes conditions such as chronic obstructive pulmonary disease, asthma, lymphangioleiomyomatosis, and bronchiolitis obliterans syndrome. For example, lung obstruction adversely affects many aspects of a patient's health, such as lung function and exercise capacity. Pulmonary rehabilitation is widely used in patients with obstructive airway disease, and the prescription of pulmonary rehabilitation depends on exercise capacity parameters such as peak oxygen uptake (peak VO2), peak workload, and anaerobic threshold. However, patients often have difficulty achieving training goals due to severe dyspnea during exercise. Dynamic hyperinflation is a common cause of dyspnea during exercise in patients with obstructive airway disease. Investigators aim to alleviate breathlessness by reducing dynamic hyperinflation, making it easier to achieve training goals. Methods to reduce dynamic hyperinflation include pursed lip breathing, reducing breathing rate to prolong expiratory time, using bronchodilators, and undergoing lung volume reduction surgery. Among these methods, reducing breathing rate to prolong expiratory time may be the most feasible, and investigators aim to change the rhythm and pace of breathing by adjusting the pedal rate of cycling exercise. The pedaling rate is typically set at 60 revolutions per minute. The European Respiratory Society recommended a pedal rate range of 40-70 revolutions per minute in 2019. There is still no consensus on the relationship between pedal rate and respiratory rate. This prospective observational study, using a crossover design, aims to investigate the effects of pedal rate during exercise testing on dynamic hyperinflation and exercise capacity in patients with obstructive airway disease. conditions: Obstructive Airway Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Inspiratory capacity during exercise measure: Change of FEV1 and symptoms sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital city: Taipei zip: 100 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06332807 id: NGGT002-P-2301 briefTitle: AAV Gene Therapy Clinical Study in Adult Classic PKU overallStatus: NOT_YET_RECRUITING date: 2024-05-22 date: 2030-12-30 date: 2030-12-30 date: 2024-03-27 date: 2024-03-27 name: NGGT (Suzhou) Biotechnology Co., Ltd. class: INDUSTRY briefSummary: This is a Phase 1/2, open-label, multiple-center, dose escalation and cohort expansion study to evaluate the safety and efficacy of NGGT002 in adult subjects with classic Phenylketonuria (PKU). NGGT002 is an rAAV8 based vector carrying a functional copy of the human PAH gene.

Participants will receive a single administration of NGGT002 and will be followed for safety and efficacy for 5 years. conditions: Phenylketonurias studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: NGGT002 measure: Incidence and severity of Adverse Events (AEs) measure: Change from baseline in clinical laboratory values measure: Change from baseline in 12-lead electrocardiograms (ECGs), vital signsand physical examinations measure: Change from baseline in Plasma Phe Concentration measure: Incidence of sustained plasma Phe concentration of ≤360 μmol/L at Week 12, Week 28, Week 52 and during Year 1 to 5 post dose measure: Change from baseline in total protein intake at at Week 28, Week 52 and during Year 1 to 5 post dose measure: Change in PKU Profile of Mood States (POMS) measure: Change in Phenylketonuria Quality of Life Questionnaire (PKU-QOL) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06332794 id: H-2201 briefTitle: Keep On Keep Up for Parkinson's acronym: KOKU4PD overallStatus: NOT_YET_RECRUITING date: 2024-06-03 date: 2025-03-01 date: 2025-06-30 date: 2024-03-27 date: 2024-04-24 name: Northumbria University class: OTHER name: University of Manchester name: Northumbria Healthcare NHS Foundation Trust name: Newcastle University name: Reason Digital briefSummary: The goal of this mixed methods, user research study is to evaluate the Keep On Keep Up programme for people with Parkinson's (KOKU4PD).

The main aims of the study are to:

1. To explore the usability and acceptability of the PD specific KOKU programme from a user and health care professional perspective.
2. To produce a KOKU4PD digital program that is ready for National Health Service (NHS) approval and a future effectiveness evaluation.

Participants will use the KOKU4PD app at home for 4 weeks. They will be assessed at baseline and after the 4 weeks to measure aspects of their disease status, mobility, thinking, mood and quality of life. They will also be asked to complete some questionnaires about the usability of the app. conditions: Parkinson's Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: KOKU4PD measure: Usability of the KOKU app measure: Executive clock drawing task (CLOX 1, 2) (mean Change from baseline) measure: Trail Making Test (mean Change from baseline) measure: Freezing of Gait Questionnaire (mean Change from baseline) measure: Falls Efficacy scale (mean Change from baseline) measure: Parkinson's disease quality of life questionnaire - PDQ-39 (mean Change from baseline) measure: Mini-BESTest (mean Change from baseline) measure: Two minute walk test, single and dual task (mean Change from baseline) measure: EuroQol-5 Dimension Quality of Life tool - EQ5D-5L (mean Change from baseline) measure: Activities-specific Balance Confidence (ABC) Scale (mean Change from baseline) measure: Multidimensional Fatigue Inventory (MFI) (mean Change from baseline) measure: Technology Acceptance questionnaire sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northumbria University city: Newcastle upon Tyne state: Tyne & Wear zip: NE1 8ST country: United Kingdom name: Gill Barry, PhD role: CONTACT phone: 01912277635 email: gill.barry@northumbria.ac.uk name: Julia Das role: CONTACT phone: 01912373343 email: julia.das@northumbria.ac.uk lat: 54.97328 lon: -1.61396 hasResults: False

 nctId: NCT06332781 id: 2126175 briefTitle: Intravesical Gentamicin to Prevent Recurrent UTI overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-06-01 date: 2025-07-31 date: 2024-03-27 date: 2024-03-28 name: Women and Infants Hospital of Rhode Island class: OTHER briefSummary: Feasibility assessment of intravesical gentamicin instillation (putting antibiotics directly into the bladder) versus the current standard of care of oral nitrofurantoin prophylaxis (taking a low dose of antibiotics by mouth every day) to prevent recurrent urinary tract infections (UTI) conditions: Recurrent Uti studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 30 type: ESTIMATED name: Gentamicin name: Nitrofurantoin measure: UTIs measure: Patient reported outcome measures measure: Patient reported outcome measures measure: Patient reported outcome measures measure: Patient reported outcome measures measure: Patient reported outcome measures measure: Patient reported outcome measures measure: urobiome analysis measure: urobiome analysis sex: FEMALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06332768 id: WEAN_2021 briefTitle: NIV Versus HFO Versus Standard Therapy Immediately After Weaning From Mechanical Ventilation in ARDS Patients overallStatus: COMPLETED date: 2017-09-01 date: 2022-01-01 date: 2022-03-01 date: 2024-03-27 date: 2024-03-27 name: Northern State Medical University class: OTHER briefSummary: The weaning failure is a paramount challenge when aggressive discontinuation of respiratory support in ARDS. The aim of the study is to improve weaning safety and efficacy by a transient postextubation non-invasive respiratory support. conditions: Mechanical Ventilation Complication conditions: Weaning Failure conditions: Acute Respiratory Distress Syndrome conditions: High-flow Oxygenation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized assignment primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ACTUAL name: Respiratory support measure: Weaning failure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City hospital # 1 city: Arkhangelsk state: Arkhangelsk Region zip: 163000 country: Russian Federation lat: 64.5401 lon: 40.5433 hasResults: False

 nctId: NCT06332755 id: LG-LRCL001 briefTitle: Study to Evaluate LB-LR1109 for the Treatment of Solid Tumors acronym: LB-LR1109 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-11 date: 2027-02 date: 2024-03-27 date: 2024-03-27 name: LG Chem class: INDUSTRY briefSummary: This is a Phase 1, first-in-human (FIH), multi-center, open-label, non-randomized, dose escalation study, designed to determine the Maximum tolerated dose(MTD)/Recommended Phase 2 dose(RP2D) of LB-LR1109 and to evaluate safety, tolerability, preliminary efficacy, pharmacokinetics, immunogenicity, pharmacodynamics of LB-LR1109, and its impact on quality of life in participants with unresectable and metastatic nonsmall cell lung cancer(NSCLC), head and neck squamous cell carcinoma(HNSCC), renal cell carcinoma(RCC), urothelial carcinoma, or malignant melanoma and no available standard of care treatment options. conditions: Non-small Cell Lung Cancer(NSCLC) conditions: Head and Neck Squamous Cell Carcinoma(HNSCC) conditions: Renal Cell Carcinoma(RCC) conditions: Urothelial Carcinoma conditions: Malignant Melanoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: LB-LR1109 measure: MTD and/or RP2D of LB-LR1109 in participants with advanced or metastatic solid tumors measure: Incidence of Treatment-Emergent Adverse Events of LB-LR1109 measure: Preliminary efficacy of LB-LR1109 measure: Anti-tumor efficacy of LB-LR1109 measure: Pharmacokinetic profile of LB-LR1109 measure: Characterize PK of LB-LR1109 measure: Immunogenicity of LB-LR1109 measure: Quality of life of participants sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06332742 id: QXZS for DOR briefTitle: Real-world Evaluation of Qingxin Zishen Decoction on Ovarian Reserve Function Clinical Efficacy in Patients With Decreased overallStatus: RECRUITING date: 2023-11-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-27 date: 2024-04-04 name: Yun Chen class: OTHER briefSummary: A prospective cohort study evaluated the clinical efficacy of Qingxin Zishen Decoction conditions: Decreased Ovarian Reserve studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 178 type: ESTIMATED measure: Traditional Chinese medicine syndrome score measure: serum sex hormone levels measure: serum AMH levels measure: transluminal ultrasound evaluation of ovarian antral follicles and other parameters (AFC) measure: Seven items of thyroid function measure: natural pregnancy rate sex: FEMALE minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: Jiangsu Provincial Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine status: RECRUITING city: Nanjing state: Jiangsu zip: 210023 country: China name: Chen Yun role: CONTACT phone: 8613675167221 email: 66teoyq@gmail.com lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06332729 id: EG,KFS,lab reserach 6 briefTitle: Universal Exercise Unit Versus Functional Electrical Stimulation On Genu Recurvatum In Diplegic Cerebral Palsy overallStatus: RECRUITING date: 2024-02-01 date: 2024-05-15 date: 2024-06-15 date: 2024-03-27 date: 2024-03-27 name: Mahmoud Reda Elsharkawy class: OTHER briefSummary: Summary:

Inclusion Criteria:

* Children aged four to eight years.
* Grade of spasticity ranging from 1 to 1+ on the Modified Ashworth scale.
* Classified as Level I or II on the Gross Motor Functional Classification System (GMFCS).
* Ability to follow verbal commands and instructions.

Exclusion Criteria:

* Previous neurological or orthopedic surgery in the lower extremities.
* Botox injection in the lower extremities within the past six months.
* Fixed deformity in the joints of the lower limb.
* Genu recarvatum secondary to surgery.
* Severe hearing and visual defects.

Materials for Subject Selection and Evaluation:

* Modified Ashworth Scale for muscle tone assessment.
* Gross Motor Functional Classification System (GMFCS) for functional activity classification.
* Digital goniometer for measuring the angle of knee hyperextension.
* Lafayette Manual Muscle Tester for quantifying muscle strength.

Methods:

* Assessment of muscle tone using the Modified Ashworth Scale, evaluating spasticity in calf muscles and hip/knee extensors.
* Evaluation of gross motor function using the GMFCS.
* Assessment of genu recarvatum using a digital goniometer.
* Assessment of muscle strength using the Lafayette Manual Muscle Tester, focusing on hamstrings and tibialis anterior muscles.
* Assessment of range of motion in the knee joint using Kinovea software.
* Treatment procedures involving physical therapy sessions with a combination of exercises and interventions tailored to each group (Group A and Group B).

Group A Treatment:

- Designed physical therapy program combined with pulley therapy for muscle strengthening.

Group B Treatment:

- Designed physical therapy program combined with functional electrical stimulation during walking on a treadmill for muscle stimulation.

The interventions in both groups aim to improve muscle strength, range of motion, and functional abilities in children with cerebral palsy. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 32 type: ESTIMATED name: universal exercis unit name: functional electrical stimulation measure: muscle strength using muscle tester device measure: Range of motion using kinoviea software and digital goniometer measure: range of motion for the joint using digital geniometer sex: ALL minimumAge: 4 Years maximumAge: 8 Years stdAges: CHILD facility: Physical Therapy status: RECRUITING city: Kafr Ash Shaykh country: Egypt name: Mahmoud R Elsharkawy, bachelor role: CONTACT phone: 01021417889 email: mahmoud.elsharakawy1994@gmail.com lat: 31.11174 lon: 30.93991 hasResults: False

 nctId: NCT06332716 id: KY20222234 briefTitle: Research on the Correlation Between Organoid Drug Sensitivity Testing and Precise Treatment of Gastrointestinal Tumors overallStatus: RECRUITING date: 2022-08-26 date: 2025-12 date: 2025-12 date: 2024-03-27 date: 2024-03-27 name: Jianjun Yang,MD class: OTHER briefSummary: Study the correlation between in vitro drug sensitivity screening of digestive tract tumor organoids and their clinical efficacy in anti-tumor treatment, evaluate the use of digestive tract tumor organoid drug sensitivity to predict the therapeutic effect of anti-tumor drugs, and explore new methods for personalized and precise treatment of esophageal cancer, gastric cancer, colorectal cancer, and gastrointestinal stromal tumors. conditions: Gastrointestinal Tumors，3D Organoids，Drug Sensitivity studyType: INTERVENTIONAL phases: PHASE3 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 68 type: ESTIMATED name: Based on diagnostic and treatment guidelines/expert consensus, as well as clinical treatment experience, it is recommended that no more than 9 drugs be used for drug sensitivity testing each time. measure: Progression-free survival（PFS） measure: Overall survival（OS） sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: XijingH status: RECRUITING city: Xi'an state: Shaanxi country: China name: Jianjun Yang role: CONTACT phone: 13756154175 email: yangjj@fmmu.edu.cn lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06332703 id: IACA briefTitle: Acanthamoeba and Artificial Intelligence overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2025-04 date: 2024-03-27 date: 2024-03-27 name: IRCCS Ospedale San Raffaele class: OTHER briefSummary: Acanthamoeba keratitis, caused by the pathogen Acanthamoeba spp, is recognized worldwide as a severe ocular infection that can pose potential risks to vision.

This observational retrospective and single-center study, of exploratory nature, aims to determine the possibility of identifying patterns that may be useful for future rapid diagnosis of Acanthamoeba keratitis from confocal images, leveraging the normality of corneal examination and the high specificity and sensitivity of computational models.

The data will be based on patients who have been confirmed positive through laboratory tests with proven effectiveness in detecting the infection.

The laboratory tests considered for the division of patients into their respective groups are bacterial examination, PCR examination, and culture examination.

Patients were divided into two groups, the first comprising patients positive for Acanthamoeba infection, while the second comprised patients negative for Acanthamoeba but positive for other pathogens. The study will last for 18 months.

The cohort under study includes 151 patients from the IRCCS San Raffaele Hospital who underwent the aforementioned examinations, of which 76 cases will be included in the group of patients positive for Acanthamoeba and 75 in the group of controls positive for other pathogens.

The confocal images of this cohort will be fed into artificial intelligence software. To evaluate the model, the test set will be used, and the AI model's ability will be assessed using the most commonly used metrics in the field of computer vision such as accuracy, specificity, sensitivity, and f1-score; culminating in a comprehensive evaluation of the model. conditions: Acanthamoeba Keratitis conditions: Artificial Intelligence studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 151 type: ESTIMATED measure: Determination of the potential presence of significant patterns of Acanthamoeba infection in in-vivo confocal microscopy (IVCM) images. measure: Correlation assessment between IVCM images and laboratory results. sex: ALL minimumAge: 1 Year maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06332690 id: 514.2021 briefTitle: OCT and OCT-Angiography Biomarkers of Treatment Response to Dexamethasone Implant in Macular Edema Due to Retinal Vascular Diseases - DME and RVO overallStatus: RECRUITING date: 2023-10-17 date: 2025-06 date: 2025-12 date: 2024-03-27 date: 2024-03-27 name: IRCCS Multimedica class: OTHER name: AbbVie briefSummary: The purpose of this pilot study is to evaluate different imaging parameters in patients with previously treatment-naive DME and ME due to RVO before and after treatment with dexamethasone implant, in order to find specific retinal inflammatory and microvascular biomarkers that may be predictive of treatment outcome. conditions: Diabetic Macular Edema conditions: Macular Edema Due to Diabetes Mellitus conditions: Retinal Vein Occlusion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: dexamethasone implant measure: Modification of inflammatory biomarkers on OCT and perfusion density parameters on OCT-A at 4 months after surgery (Change measure) measure: Initial clinical characteristics in patients with a gain in BCVA (Best Corrected Visual Acuity) of ≥ 5, ≥ 10, and ≥ 15 ETDRS (Early Treatment Diabetic Retinopathy Study) letters. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MultiMedica IRCCS Multimedica status: RECRUITING city: Milan zip: 20123 country: Italy name: Stela Vujosevic, MD role: CONTACT phone: +39 02 85 99 4601 email: stela.vujosevic@multimedica.it name: GAbriele Piccoli role: CONTACT phone: +39 02 85 99 4601 email: gabriele.piccoli@multimedica.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06332677 id: TERS briefTitle: Target of Suv420h1/2 in Hepatocytes overallStatus: RECRUITING date: 2023-03-01 date: 2025-02 date: 2026-02 date: 2024-03-27 date: 2024-03-27 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: Nonalcoholic fatty liver disease (NAFLD) is globally the leading cause of liver disease and frequently progresses to cirrhosis and liver cancer. The identification of effective drugs is the main unmet clinical need. Changes in liver histones methylation accompanies the development and progression of NAFLD. Our preliminary data demonstrate that inactivation of the methyltransferases SUV420H1/2 in hepatocytes protects mice against NAFLD. In this project we propose to examine the relevance of these findings by evaluating the impact of genetic deletion of hepatic SUV420H1/2 in mice fed a steatogenic diet. To further evaluate the potential for clinical translation of these results, we will next 1) evaluate the expression of SUV420H1/2 in human liver transcriptomic data and 2) analyze the impact of genetic variations on disease outcomes in population-based cohorts; 3) test an innovative therapeutic approach based on hepatocyte-targeted antisense oligonucleotides downregulating SUV420H1/2 in human liver organoids/assembloids. conditions: NAFLD studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: study the cellular and molecular mechanisms of correlation between the SUV420H1/H2 methyltransferase and the progression of liver damage in mice (San Raffaele Institute) and to confirm these findings in human samples and in vitro 3D liver models. primaryPurpose: PREVENTION masking: NONE count: 260 type: ESTIMATED name: the main genes and expression by comparing the transcriptomic lipidomic profile measure: the main genes and expression by comparing the transcriptomic lipidomic profile measure: the main genes and expression by comparing the transcriptomic lipidomic profile sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica status: RECRUITING city: Milano zip: 20122 country: Italy name: Luca Vittorio Carlo Valenti role: CONTACT phone: 02 5503 6595 email: luca.valenti@policlinico.mi.it lat: 45.46427 lon: 9.18951 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-01-26 uploadDate: 2024-03-14T09:56 filename: Prot_SAP_000.pdf size: 703523 hasResults: False

 nctId: NCT06332664 id: 2023-2330 briefTitle: Early Nutrition Intervention for M1 Stage Cancer Patients overallStatus: RECRUITING date: 2024-01-01 date: 2025-01-01 date: 2025-07-01 date: 2024-03-27 date: 2024-03-27 name: Xingchen Peng class: OTHER briefSummary: In China, the treatment of advanced-stage cancer often follows a pattern where the management of patients is primarily overseen by oncologists who focus on addressing the main clinical symptoms and intervening accordingly.

However, symptoms such as appetite loss, weight loss, and anxiety are often overlooked. It is common for clinical nutritionists to passively enter oncology wards to conduct comprehensive nutritional assessments and develop nutrition plans only when patients exhibit significant malnutrition, upon request from oncologists or patients and their families.

Against this background, the investigators integrated clinical nutritionists into the oncology treatment team and established a proactive nutritional intervention team specifically targeting M1 advanced-stage cancer patients. This initiative aims to conduct a single-center, open-label, randomized parallel-group prospective study, with the following objectives: 1) to evaluate the impact of this model on the nutritional status, survival, and quality of life of advanced-stage cancer patients, and 2) to further optimize this model for widespread replication in clinical practice. conditions: Nutrition conditions: Cancer Metastatic studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 194 type: ESTIMATED name: Early Nutrition Intervention measure: the incidence of cachexia measure: overall survival ；progression-free survival measure: Physical Fitness Status measure: BMI measure: Nutritional risk and malnutrition status measure: Patient's emotional changes measure: Caregiver psychological burden measure: Patient's physical, social, and cognitive functioning measure: incidence of Sarcopenia measure: Nutritional risk and malnutrition status measure: Patient's emotional changes sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital, Sichuan Universit status: RECRUITING city: Chengdu state: Sichuan zip: 610041 country: China name: XingChen Peng, Ph.D role: CONTACT phone: +8618980606753 email: pxx2014@163.com lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06332651 id: NL84684.091.23 briefTitle: Metabolic Availability in Older and Younger Men acronym: YOMA overallStatus: RECRUITING date: 2024-02-19 date: 2024-12-31 date: 2025-04-01 date: 2024-03-27 date: 2024-03-27 name: Wageningen University class: OTHER briefSummary: The main goal of this study is to determine the metabolic availability of methionine in black beans, lysine in sorghum and lysine in milk using the indicator amino acid oxidation method both in older and in younger men. conditions: Ageing studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: It is a parallel intervention study. The intervention does not involve a drug or biologic product, however does involve an adaptation diet and a diet with measured amino acids dissolved in water, during the test day. We investigate the amino acid metabolic availability using the IAAO method. primaryPurpose: PREVENTION masking: NONE count: 28 type: ESTIMATED name: Black beans name: Milk name: Sorghum measure: Metabolic availability of methionine in black beans and lysine in milk and sorghum measured with the indicator amino acid oxidation method. sex: MALE minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wageningen University & Research status: RECRUITING city: Wageningen state: Gelderland zip: 6708PB country: Netherlands name: Fenna Hinssen, MSc role: CONTACT phone: +031648043165 email: yoma@wur.nl name: Karen Fransen, MSc role: CONTACT phone: +031648043165 email: yoma@wur.nl lat: 51.97 lon: 5.66667 hasResults: False

 nctId: NCT06332638 id: IN_APA_124 briefTitle: PK, PD and Safety of Tegoprazan 12.5 mg After Oral Administration in Healthy Subjects overallStatus: ENROLLING_BY_INVITATION date: 2024-03-19 date: 2024-07-31 date: 2024-07-31 date: 2024-03-27 date: 2024-03-27 name: HK inno.N Corporation class: INDUSTRY briefSummary: The primary objective of this study is to explore pharmacokinetics, pharmacodynamics, and safety of tegoprazan 12.5 mg in healthy subjects when orally administered as a single dose or as multiple doses twice daily. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Tegoprazan 12.5mg name: Tegoprazan 25mg name: Famotidine 20mg measure: Cmax of tegoprazan and tegoprazan's metabolite M1 measure: AUC0-t of tegoprazan and tegoprazan's metabolite M1 measure: AUC0-∞ of tegoprazan and tegoprazan's metabolite M1 measure: Tmax of tegoprazan and tegoprazan's metabolite M1 measure: t1/2β of tegoprazan and tegoprazan's metabolite M1 measure: CL/F of tegoprazan measure: Vd/F of tegoprazan measure: Css,max of tegoprazan and tegoprazan's metabolite M1 measure: Css,min of tegoprazan and tegoprazan's metabolite M1 measure: Css,avg of tegoprazan and tegoprazan's metabolite M1 measure: AUCtau,ss of tegoprazan and tegoprazan's metabolite M1 measure: Tmax,ss of tegoprazan and tegoprazan's metabolite M1 measure: t1/2β,ss of tegoprazan and tegoprazan's metabolite M1 measure: CLss/F of tegoprazan measure: Vdss/F of tegoprazan measure: Accumulation index of tegoprazan measure: Fluctuation of tegoprazan measure: 24-hour, daytime and nighttime mean pH measure: 24-hour, daytime and nighttime median pH measure: 24-hour, daytime and nighttime TpH>3(%) measure: 24-hour, daytime and nighttime TpH>4(%) measure: 24-hour, daytime and nighttime Δ TpH>3(%) measure: 24-hour, daytime and nighttime Δ TpH>4(%) measure: 24-hour, daytime and nighttime Δ mean pH measure: 24-hour, daytime and nighttime Δ median pH sex: ALL minimumAge: 19 Years maximumAge: 45 Years stdAges: ADULT facility: Inje University Busan Paik Hospital city: Busan zip: 47392 country: Korea, Republic of lat: 35.10278 lon: 129.04028 hasResults: False

 nctId: NCT06332625 id: PNRR-MR1-2022-12375648 briefTitle: The Fingerprinting of Inherited Leukoencephalopathies: A New Brain Imaging, Genetic and Clinical Assessment acronym: FIABA overallStatus: RECRUITING date: 2023-05-22 date: 2024-02-05 date: 2025-11-22 date: 2024-03-27 date: 2024-03-27 name: IRCCS Fondazione Stella Maris class: OTHER name: Oasi Research Institute-IRCCS name: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta name: IRCCS Ospedale San Raffaele briefSummary: Inherited leukoencephalopathies are a broad spectrum of genetically determined disorders, characterized by specific involvement of the white matter of the central nervous system. These pathologies are almost as common as other acquired white matter disorders, such as acute disseminated encephalomyelitis and multiple sclerosis. The onset can occur at any age, from prenatal life to adulthood, and the clinical picture is mostly progressive, but can also be non-evolving or, rarely, improve over time. Thanks to new diagnostic approaches, including next-generation genetic sequencing and recognition of magnetic resonance imaging patterns, in recent years the investigators have witnessed a significant increase in the number of genetically defined leukoencephalopathies. However, despite advances in genetic studies, inherited leukoencephalopathies include a large number of inherited white matter diseases in children and adults and remain of unknown cause in many patients (about 40%). This significant percentage of cases of unknown etiology represents a major challenge for public health, both in prognostic terms and, consequently, economically. However, even in leukoencephalopathies of genetically determined cause, the absence of specific biomarkers can be a limiting factor in the design and execution of clinical studies in search of promising therapies. As in other fields of neurology, the integration of clinical and genetic data with brain MRI data plays a fundamental role in the diagnostics of subjects affected by these pathologies. Currently, the methodologies commonly used in magnetic resonance imaging are qualitative, and evaluate brain lesions through the contrast between white and gray matter. The lack of specific biomarkers is therefore a limiting factor in the design of therapeutic challenges. In this regard, the development of new multiparametric quantitative magnetic resonance imaging (qMRI) methods could allow the investigators to identify new biomarkers to assess the etiology behind leukodystrophies, increasing diagnostic power and understanding the progression or improvement of leukoencephalopathy for both future trials and existing therapies. In this perspective, recent rapid "transient-state" magnetic resonance imaging methods, such as MR Fingerprinting (MRF), have proven effective in efficiently separating different components of brain tissue. These techniques consist of rapid and highly undersampled acquisitions performed by continuously changing the MR sequence parameters, thus obtaining a signal evolution that is unique for each combination of underlying tissue properties. Furthermore, if these techniques have already shown their validity at 3 Tesla, they could be even more informative in 7T MRI where the use of qMRI could provide more details thanks to the high image resolution.

The project's objective is to evaluate and validate new and innovative quantitative magnetic resonance imaging (qMRI) methodologies at both clinical and ultra-high fields in inherited leukodystrophies and those of unknown etiology.

This is a national, multi-institutional, multicenter exploratory study on the potential identification and predictability of early structural and metabolic markers in quantitative MRI at 3T and 7T in the diagnosis and follow-up of leukodystrophy and leukoencephalopathy in adults and during development.

The study will include multiple sub-studies:

1. A cross-sectional study in leukoencephalopathies at clinical fields.
2. A longitudinal study in leukoencephalopathies at 3T: natural history and therapy outcomes.
3. A cross-sectional and longitudinal study at 7T: The added value of ultra-high-field Magnetic Resonance Imaging in leukoencephalopathies. conditions: Leukoencephalopathies studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Brain quantitative magnetic resonance imaging measure: Quantitative Susceptibilty Mapping, QSM measure: Fractional Anisotropy, FA measure: Mean Diffusivity, MD measure: Relaxation times measure: Myelin water fraction, MWF measure: Neuromotor skills measure: Neuromotor skills measure: Epilepsy symptoms measure: Electroencephalography features measure: Neuro-psychological profile sex: ALL minimumAge: 0 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT facility: IRCCS Associazione Oasi Maria SS Troina status: RECRUITING city: Troina state: Enna zip: 94018 country: Italy name: Maurizio Elia role: CONTACT lat: 37.78437 lon: 14.59605 facility: Ospedale San Raffaele status: RECRUITING city: Milano zip: 20132 country: Italy name: Cristina Baldoli role: CONTACT lat: 45.46427 lon: 9.18951 facility: Fondazione Istituto Neurologico Carlo Besta status: RECRUITING city: Milano zip: 20133 country: Italy name: Stefania Magri role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06332612 id: 8420224AROM briefTitle: Metformin Repurposing in Oral Submucous Fibrosis: Unveiling In Vitro Signaling Pathways, Progressing to Clinical Trial acronym: MROSF overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2024-12 date: 2024-03-27 date: 2024-03-27 name: Ziauddin University class: OTHER briefSummary: OSF is a widespread health issue in Asian countries, notably Pakistan, linked to the consumption of pan, chalia, and gutka, affecting a rising number of young individuals as an epidemic. This condition significantly impairs oral function, resulting in ulcers and chronic lesions, often progressing to oral cancer. Current treatments focus on symptom relief and halting disease progression. This study explores the repurposing of metformin, an FDA-approved drug with antifibrotic properties, for OSF treatment. Our objective is to unveil its therapeutic potential and comprehend its impact on the dysregulated signaling pathways associated with OSF. This research offers promising insights for an enhanced management approach, providing hope for those grappling with this debilitating condition conditions: Oral Submucous Fibrosis studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1. In Vitro (Cell Line) Study Design: Experimental in vitro study using OSF cell lines.

Groups:

* Metformin-treated
* Control (untreated)
* Vehicle control Clinical Trial Study Design: A pilot Randomized Controlled Trial (RCT) translating the in vitro findings into a clinical setting. It would be a single-blind, placebo-controlled designAll groups will undergo a 24-week intervention phase. Group 1 will receive standard treatment including topical cream betamethasone thrice daily and Pentoxifylline tablet 400 mg twice daily. Group 2 will receive Metformin 500 mg thrice daily. Group 3 will receive topical cream metformin thrice daily. All groups will be instructed to perform a stick mouth opening exercise twice daily, alternating sides, holding the stick for 10 minutes on each side, with a 10-minute rest in between. All groups will be single blinded to the intervention. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: It would be a single-blind, placebo-controlled design whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Metformin Hydrochloride name: betamethasone dipropionate name: Pentoxifylline measure: Cell Viability measure: Cytotoxicity measure: Morphological Changes Cell Shape measure: Morphological Change Cell Density measure: Morphological Change Extracellular Matrix (ECM) Structure measure: Cell Migration Assays measure: Cell Invasion Assays measure: Apoptosis Analysis measure: Assess Signaling pathway with optimal metformin concentration measure: Clinical Oral Mucosal Characteristics measure: Patient Burning sensation pain measure: Patient Mouth Opening sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Ziauddin University city: Karachi state: Sindh zip: 74700 country: Pakistan name: Afifa Razi, FCPS OMFS role: CONTACT phone: +92 300 2247389 email: afifa.razi@zu.edu.pk name: Shumaila Usman, PhD role: CONTACT phone: +92 336 1882779 email: shumaila.usman@zu.edu.pk name: Afifa Razi, FCPS role: PRINCIPAL_INVESTIGATOR name: Shumaila Usman, PhD role: SUB_INVESTIGATOR name: Yamna Khurshid, PhD role: SUB_INVESTIGATOR lat: 24.8608 lon: 67.0104 hasResults: False

 nctId: NCT06332599 id: rjhy20240001 briefTitle: Minocycline for Helicobacter Pylori Rescue Treatment overallStatus: RECRUITING date: 2021-10-01 date: 2024-04-30 date: 2034-06-30 date: 2024-03-27 date: 2024-03-27 name: Shanghai Jiao Tong University School of Medicine class: OTHER briefSummary: Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. We previously showed that the efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events.This study aimed to evaluate the efficacy and tolerability of four different regimens with minocycline and metronidazole compared to classical bismuth quadruple therapy for H. pylori rescue treatment in a real-world setting. conditions: Helicobacter Pylori Infection studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 600 type: ESTIMATED name: BQT name: EBM4M4 name: EBM3M3 name: EBM2M4 name: EBM2M3 measure: Helicobacter pylori eradication rate measure: Rate of adverse effects measure: Compliance rate sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University status: RECRUITING city: Shanghai state: None Selected zip: 200127 country: China name: Yu Huang role: CONTACT phone: 0198621791879 email: 15626211482@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06332586 id: 202311087RINA briefTitle: The Learning Effect of Applying Diversified Teaching in Emergency Injury Classification -Taking the Emergency Nurse of a Regional Hospital in Yunlin County as an Example overallStatus: ENROLLING_BY_INVITATION date: 2024-03-25 date: 2024-04-04 date: 2024-05-05 date: 2024-03-27 date: 2024-03-27 name: National Taiwan University Hospital class: OTHER briefSummary: "Triage" is the first process of emergency treatment. It is mainly based on the severity of the disease and the appropriate allocation of limited people, time, place, and medical resources. It is very important and related to the quality of medical care. In order to accurately judge the severity of patients, reduce the individual errors of artificial memory and increase the consistency of the judgment of triage levels, the new emergency five-level triage classification standard (Taiwan Triage and Acuity Scale) was implemented in 2010. , TTAS), the purpose is to allocate medical resources in the most appropriate manner at the appropriate time. It has been revised many times so far, so correct injury classification can maximize the safety of people's lives. This article reviews the relevant literature and finds that to have an efficient injury classification so that each patient receives appropriate medical allocation, an organized, effective and systematic injury inspection process structure is needed to enable the injury nurse to perform correct inspections. Injury skills and cognition should be actively promoted, and this policy must require traumatization nurses to continuously update their traumatization cognition and skills, and must also continue to conduct regular assessments and reviews to continuously improve the quality of traumatization grading by traumatization nurses. It can be seen that triage nurses must have skills, knowledge, attitudes and systems to improve the accuracy of triage levels and ensure the treatment of patients who need priority treatment . Therefore, this study can be used to understand the learning effectiveness of trauma care before and after diversified teaching, which can be used as a basis for teaching new trauma care nurses. conditions: Triage studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 22 type: ESTIMATED name: Diversified teaching measure: Improving the injury diagnosis ability of triage diagnosis nurses through diversified teaching sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Taiwan city: Taipei zip: Taiwan country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06332573 id: 24-06 briefTitle: Impact of Onco-sexology Support on the Quality of Life of Patients Newly Diagnosed for Cancer acronym: SEXOCARE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-05 date: 2026-12 date: 2024-03-27 date: 2024-03-27 name: Hôpital Européen Marseille class: OTHER briefSummary: Onco-sexology as a supportive care for patients treated for cancer is still rarely discussed or even non-existent in 2022. However, it's recommended to integrate the preservation of sexual health throughout the treatment and post-cancer process, given the impact of cancer, treatments and the importance of intimate life for a majority of patients.

Onco-sexology is one of the supportive care services validated by The French National Cancer Institute (INCa). It is also an objective of the 2014-2019 cancer plan and the 2017-2030 national sexual health strategy plan.

Although sexuality is one of the fundamental needs of the human being, including in the case of a chronic disease or cancer diagnosis, the lack of training of health professionals to deal with intimate life, the difficulty to exchange on this subject between caregivers and patients, the lack of financial support for onco-sexology consultations, are all obstacles to the global management of oncology patients. However, it's a request from patients to be able to discuss the subject in an intimate way with a professional.

While onco-sexology is already recommended as supportive care, a study on the impact of the delay in the management of sexual difficulties on quality of life could provide a sufficient level of evidence to change the practices and the care pathway of the oncology patient. Our objective is to study whether early management in onco-sexology has an impact on quality of life compared to late management (ie onco-sexology consultation before vs. after introduction of systemic oncological treatment). conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 168 type: ESTIMATED name: Onco-sexology support name: Onco-sexology support measure: Rate of patients with improved quality of life as measured by the 36-Item Short Form Survey (SF-36) at the end of onco-sexology support measure: Evaluation of the quality of life of patients at 6 and 12 months after the end of onco-sexology support through the 36-Item Short Form Survey (SF-36) questionnaire measure: Evaluation of the quality of sexual life at the end of the onco-sexology support in both groups through specific questionnaires (The sexual quality of life-female and men) measure: Evaluation of the quality of sexual life at 6 and 12 months after the end of the onco-sexology support through specific questionnaires (The sexual quality of life-female and men) measure: Evaluation of the body image, at the end of the onco-sexology support through the "Body Image Scale ". measure: Evaluation of the body image, of the patient at 6 and 12 months after the last consultation with the onco-sexologist through the "Body Image Scale". measure: Evaluation of the satisfaction of the patient at the end of the care in onco-sexology care measure: Rate of patients expressing sexual difficulties during the consultation of announcement sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Européen Marseille city: Marseille country: France name: Myriam BENNANI role: CONTACT phone: 0413428351 email: m.bennani@hopital-europeen.fr lat: 43.29551 lon: 5.38958 hasResults: False

 nctId: NCT06332560 id: NL86247.091.24 briefTitle: Pain in Endometriosis And the Relation to Lifestyle acronym: PEARL overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2027-05 date: 2024-03-27 date: 2024-03-27 name: Radboud University Medical Center class: OTHER name: ZonMw: The Netherlands Organisation for Health Research and Development briefSummary: The goal of this clinical trial is to investigate the effect of an anti-inflammatory diet intervention on health related quality of life and pain symptoms in women with endometriosis. And whether the addition of CBT enhancing this effect. The secondary objective is to investigate the effect of an anti-inflammatory diet on inflammatory characteristics in serum and menstruum samples as well as the effect on the gut and vaginal microbiome.

Participants will be randomized between standard care (control group), standard care and an anti-inflammatory diet, or standard care, anti-inflammatory diet and cognitive behavioral therapy.

Participants will follow an anti-inflammatory diet based on the Dutch Dietary Guidelines for 12 weeks. They will receive personalized dietary advice from a dietician and recipes will be available. cognitive behavioral therapy will be administered in a total of seven individual sessions led by a psychotherapist. The content of these sessions will be psycho-education regarding pain mechanisms and diet. conditions: Endometriosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 170 type: ESTIMATED name: Anti-inflammatory diet (DI) name: Cognitive behavioral therapy (CBT) measure: Change in Pain intensity assessed by the Numerical Rating Scale measure: Change in inflammatory characteristics in menstruum measure: Change in Health Related Quality of Life assessed by the Endometriosis Health Profile 30 measure: Change in general Quality of Life assessed by the Short Form 36 measure: Change in the composition of vaginal and intestinal microbiome measure: Change in Objective stress assessed by measuring scalp hair cortisol levels measure: Adherence and anti-inflammatory status of the diet measure: Change in sleep quality assessed by the PSQI measure: Change in physical activity level assessed by the IPAQ-SF measure: Change in Subjective stress assessed by the Perceived Stress Scale measure: Changes in pain cognitions assessed by the Pain anxiety symptom scale measure: Changes in pain cognitions assessed by the pain catastrophizing Scale measure: Changes in Fatigue assessed by the checklist individual strength measure: Anti-inflammatory diet rating sex: FEMALE minimumAge: 17 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Radboud University Medical Center city: Nijmegen country: Netherlands name: E Huijs, B role: CONTACT name: A.W. Nap, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 51.8425 lon: 5.85278 hasResults: False

 nctId: NCT06332547 id: TICVS briefTitle: Transfusion in Cardiac Valve Surgery acronym: TICVS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-12-30 date: 2027-12-30 date: 2024-03-27 date: 2024-03-27 name: Guangdong Provincial People's Hospital class: OTHER briefSummary: This prospective, randomized controlled study is aimed to figure out suitable transfusion threshold in patients undergoing cardiac valve surgery under cardiopulmonary bypass(CPB). Patients are randomly assigned to restrictive and liberal transfusion group and receive blood transfusion during and after surgery. Compare primary and secondary outcomes of two groups. conditions: Cardiac Surgery With Cardiopulmonary Bypass conditions: Valve Heart Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 1600 type: ESTIMATED name: Restrictive Transfusion Strategy name: Liberal Transfusion Strategy measure: A composite of postoperative morbidity and mortality measure: Rate of reoperation measure: Length of ICU Stays measure: Length of Postoperative Hospital Stay measure: Number of Blood Transfusion measure: Duration of mechanical ventilation measure: Postoperative thoracic fluid volume in the first 24 hours measure: Number of participants with postoperative atrial fibrillation measure: Number of participants with new-onset renal failure with dialysis measure: Number of participants with acute kidney injury measure: Number of participants with delirium measure: Hospitalization expense sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Provincial People's Hospital city: Guangzhou state: Guangdong zip: 510145 country: China name: Huang Huanlei, Phd role: CONTACT phone: 765 714 9765 email: hhuanlei@hotmail.com name: Huang huanlei, Phd role: PRINCIPAL_INVESTIGATOR name: Zhao Junfei, Phd role: PRINCIPAL_INVESTIGATOR name: He Biaochuan, Phd role: PRINCIPAL_INVESTIGATOR name: Zhang Zhaolong, BD role: PRINCIPAL_INVESTIGATOR name: Wang Zhenzhong, MD role: PRINCIPAL_INVESTIGATOR name: Wang Qiuji, MD role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06332534 id: M14-671 briefTitle: Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease overallStatus: NOT_YET_RECRUITING date: 2024-07-26 date: 2032-03-22 date: 2034-12-20 date: 2024-03-27 date: 2024-03-27 name: AbbVie class: INDUSTRY briefSummary: Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective oral Upadacitinib is in treating moderately to severely active Crohn's Disease in pediatric participants aged 2 to 18 years old who have had inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy.

Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active CD and is being developed for moderate- to severely active CD in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: a 12-week open-label induction phase which means that the study doctor and participants know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 52-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 156-week open-label extension of Period 1. Approximately 110 pediatric participants with moderate to severely active CD will be enrolled at approximately 92 sites worldwide.

Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will have a safety follow up for 30 days after discontinuation from any time point within the study.

There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. conditions: Crohn's Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Upadacitinib measure: Percentage of participants who achieved clinical response per the Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12, with clinical remission per the PCDAI at Week 64 measure: Achievement of endoscopic response at Week 64 in participants who achieved clinical response per PCDAI at Week 12. measure: Number of Participants with Adverse Events measure: Achievement of clinical remission per PCDAI measure: Achievement of endoscopic response measure: Achievement of endoscopic remission measure: Achievement of clinical response per PCDAI measure: Achievement of clinical response per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12 measure: Achievement of endoscopic remission at Week 64 in participants who achieved clinical response per PCDAI at Week 12 measure: Achievement of corticosteroid (CS)-free clinical remission per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12 sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06332521 id: 23CH296 id: ANSM type: OTHER domain: 2024-A00286-41 briefTitle: Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment acronym: BABYCRY_1000 overallStatus: RECRUITING date: 2024-03-20 date: 2029-04-01 date: 2029-04-01 date: 2024-03-27 date: 2024-04-26 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: Crying is a vital communication signal for the baby. Product of a complex physiological process, it reflects not only the organization and functioning of the cortical central nervous system and the function of sympathetic and parasympathetic autonomic regulation but also the integrity of three entities: the lungs responsible for ventilatory mechanics and respiratory rhythm, the larynx and its vocal cords as a phonatory organ, and the oropharyngeal tract guaranteeing the resonance of the sound emitted by the vocal cords.

Crying is usually caused by pain, discomfort, hunger, or separation from parents or other caregivers. Crying carries essential information from birth, the expression of which depends closely on the neuroanatomical and functional brain integrity of the child. On a bioacoustic level, crying consists of sequences of complex acoustic signals produced by the vocal folds and filtered by the vocal tract. The vibration frequency of the vocal cords determines the cry's fundamental frequency f0 (and the harmonic frequencies), which is responsible for its more or less low or high pitch. Other acoustic cues also characterize each baby's cry. conditions: Newborn; Vitality conditions: Premature Infants conditions: Infant Development studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1100 type: ESTIMATED name: Acoustic signal analysis method measure: Fundamental frequency f0 (Hz) measure: Bailey-4 quantitative scale measure: Percentage voiced frames measure: Harmonics of f0 (Hz) measure: Median pitch f0 (Hz) measure: Harmonicity (dB) measure: Jitter (Percentage), measure: Q25 (Percentage) measure: Median Cepstral Peak Prominence (CPP) (dB) sex: ALL maximumAge: 4 Days stdAges: CHILD facility: Chu de Saint-Etienne status: RECRUITING city: Saint-Étienne zip: 42055 country: France name: Hugues PATURAL, MD-PhD role: PRINCIPAL_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False

 nctId: NCT06332508 id: 2022/00406 briefTitle: Pulsed Electromagnetic Fields (PEMFs) - A Highly Selective Breast CAncer Treatment pLatform (PASCAL) overallStatus: RECRUITING date: 2022-12-30 date: 2025-12 date: 2025-12 date: 2024-03-27 date: 2024-03-27 name: National University Hospital, Singapore class: OTHER name: National University of Singapore briefSummary: To assess the safety and tolerability of combined PEMFs and anthracycline-based chemotherapy in subjects who are undergoing neoadjuvant chemotherapy for breast cancer treatment. conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Pulsed electromagnetic fields (PEMFs) name: Anthracycline-based chemotherapy measure: Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0 measure: Treatment response as assessed by clinical measurement of tumor size using calipers sex: FEMALE minimumAge: 21 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National University Hospital status: RECRUITING city: Singapore zip: 119074 country: Singapore name: Joline Si Jing Lim role: CONTACT phone: 69082222 email: joline_sj_lim@nuhs.edu.sg name: Joline Si Jing Lim role: PRINCIPAL_INVESTIGATOR lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06332495 id: RC23_0573 id: 2024-A00025-42 type: OTHER domain: ANSM (IDRCB) briefTitle: Research Project on the Risk of Discomfort, Pain, Alteration of Skin Condition in Bedpan Use by Patients and Caregivers acronym: RIDAECUBA overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-06-03 date: 2024-03-27 date: 2024-04-22 name: Nantes University Hospital class: OTHER briefSummary: the hypothesis is that the current bedpan is not adapted to the diversity of patients encountered. It is necessary to collect the opinions of patients themselves on the current pool in different departments in order to validate our hypothesis.

The objective is to evaluate pain in patients with reduced or very reduced mobility caused by the bedpan currently used in current practice through an observational study. conditions: Nurse-Patient Relations studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Questioning the patient during hygiene care measure: Assessment of pain in a patient with reduced or very reduced mobility when using a bedpan. measure: Assess the proportion of patients with a MCID of the pain felt by the patient in pre-installation > 1.3 measure: Assess the maximum pain felt by the patient pre/post and per/post use of the bedpan. measure: Assess patient discomfort on the bedpan measure: Assess alteration of skin condition at the seat of the patient using the bedpan measure: Assess the caregiver's pain when handling the bedpan, placing the bedpan in position and removing the bedpan. measure: Assess the risk factors associated with the onset of pain when placing a bedpan. measure: Assess the difficulty of positioning and removing the bedpan. measure: Assess bedpan stability during use measure: Evaluate the effect of time spent on the bedpan on: pain, skin alteration and discomfort sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nantes University Hospital city: Nantes state: Loire Atlantique zip: 44093 country: France name: Pia SECHER-CAILLETEAU role: CONTACT email: pia.secher@chu-nantes.fr lat: 47.21725 lon: -1.55336 facility: CHU Cholet city: Cholet country: France name: Nelly DIXNEUF role: CONTACT phone: (+33) 2 41 49 69 85 email: nelly.dixneuf@ch-cholet.fr lat: 47.06667 lon: -0.88333 facility: CHU Laval city: Laval country: France name: ROMAIN CHAMPAGNE role: CONTACT phone: (+33) 672091548 email: Romain.CHAMPAGNE@chlaval.fr lat: 48.06667 lon: -0.76667 facility: CH Le Mans city: Le Mans country: France name: Emmanuelle Lecompte role: CONTACT phone: (+33) 681220543 email: gsicot@ch-lemans.fr lat: 48.0 lon: 0.2 facility: CHU Orleans city: Orléans country: France name: Guillaume FOSSAT role: CONTACT phone: (+33) 2 38.65.13.18 email: guillaume.fossat@chu-orleans.fr lat: 47.90289 lon: 1.90389 hasResults: False

 nctId: NCT06332482 id: M0303023RP briefTitle: Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-30 date: 2024-05-20 date: 2024-09-15 date: 2024-03-27 date: 2024-03-27 name: Mansoura University class: OTHER briefSummary: This study will compare the occlusal accuracy of different techniques for recording maxillomandibular relationships in a Complete digital workflow to construct full arch implant-supported screw-retained restoration. conditions: Prosthesis Durability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: digital impressions will be made for each patient,3 technique will be used to determine intermaxillary relation. Occlusal prematurties of final prosthesis will compared using occlusense device and all patients will be followed up for one year primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 10 type: ACTUAL name: Implant supported screw retained prosthesis measure: measurement of occlusal prematurity measure: prosthestic complications sex: ALL minimumAge: 45 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mansoura University ,Faculty of dentistry city: Mansoura zip: P.O.Box:35516 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06332469 id: INSERT feasibility briefTitle: Evaluation of an Internet Based Education and Support Program for Patients Awaiting Kidney Transplantation acronym: INSERT overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2025-10-31 date: 2025-10-31 date: 2024-03-27 date: 2024-03-27 name: Linkoeping University class: OTHER_GOV briefSummary: The goal of this study is to test the feasibility study of an internet based education and support program for patients awaiting kidney transplantation. The study is designed as a national pilot randomized controlled trial with a waitlist control group, to test the feasibility, acceptability, and potential effects of the intervention on patients' physical and mental health. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The intervention group gets immediate access to the 9 week program, and the waitlist control group gets access after a 9 week waiting period. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 80 type: ESTIMATED name: Internet based education and support program for patients awaiting kidney transplantation measure: Kidney transplant understanding tool (K-TUT) measure: Self-care in chronic illness inventory v.4c measure: The Self-Efficacy for Managing Chronic Disease 6-item Scale (SES6G measure: Pearlin Mastery Scale measure: The Depression Anxiety Stress Scales 21 (DASS-21) measure: Acceptance of chronic health conditions scale (ACHC) measure: EQ-5D-5L sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06332456 id: ICM 2023-3169 briefTitle: Assessment of Renal Microcirculation With Rubidium Positron Emission Tomography acronym: RESIST overallStatus: RECRUITING date: 2023-07-04 date: 2024-12 date: 2024-12 date: 2024-03-27 date: 2024-03-27 name: Matthieu Pelletier-Galarneau, MD MSc class: OTHER briefSummary: The aim of this study is to demonstrate that positron emission tomography imaging with Rubidium-82 (radioactive tracer) can non-invasively detect and quantify changes in renal blood flow (renal perfusion) and renal vascular resistance in both healthy subjects and patients with renal insufficiency. Ultimately, the results of this study will contribute to a better understanding of the role of positron emission imaging in the evaluation of patients with renal diseases. conditions: Renal Microcirculation With Rubidium Positron Emission Tomography studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Renal blood flow in units of mL/min/100g measure: Renal vascular resistance in units of mmHg/mL/min/100g measure: Correlation between renal vascular resistance measured with PET and measured with echography measure: Coefficient of repeatability of renal blood flow sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montreal Heart Institute status: RECRUITING city: Montréal state: Quebec zip: H1T 1C8 country: Canada name: Matthieu Pelletier-Galarneau role: CONTACT phone: 5143763330 phoneExt: 4418 email: matthieu.pelletier-galarneau@icm-mhi.org lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06332443 id: CER-CEMTL-2023-3086 briefTitle: Randomized, Controlled Trial Comparing the Effectiveness of Sedation-Epidural Anesthesia to Spinal Anesthesia in Outpatient Hip or Knee Arthroplasty. acronym: RCT SEA vs SA overallStatus: RECRUITING date: 2023-03-15 date: 2025-03-15 date: 2026-03-15 date: 2024-03-27 date: 2024-03-27 name: Maisonneuve-Rosemont Hospital class: OTHER name: Mina Wahba Morcos name: Issam Tanoubi name: Pierre Drolet name: Ariane Clairoux name: Veronique Brulotte name: Marie-Eve Bélanger name: Philippe Richebé name: Karina Pellei briefSummary: To our knowledge, no study has compared the difference between these two NA techniques. Early postoperative adverse events like uncontrolled pain, orthostatic hypotension, urinary retention, and prolonged motor block are linked to late patient mobilization, prolong hospitalization and failure to discharge in outpatient setting. The type of anesthesia used may have an important impact. Therefore, this study has the potential to improve the already established ERAS program and improve patients care perioperative and postoperative. Showing that SED-EA and SA are equivalent will allow for a more efficient and reliable technique for THA/TKA ERAS program that can be further translated into other lower limb surgeries. conditions: Knee Injuries and Disorders conditions: Hip Injuries conditions: Anesthesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a RCT with two parallel treatment groups: THA/TKA with single-shot SA group and THA/TKA with SED-EA group primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The group assignment will be given to the intraoperative anesthesia team by writing, by a research team member who will not participate in postoperative assessments. The intraoperative anesthesia team will not be blinded to the group assignment, but surgeons, patients, and assessors will be blinded. For the SA group, a sham epidural catheter will be placed on the patient's back by the anesthesia team in order to keep the surgeons, patients and assessors blind to the randomization group. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 132 type: ESTIMATED name: Spinal anesthesia name: Sedation epidural anesthesia measure: Adverse Events measure: Time needed by the anesthesiologist to perform the technique measure: Time needed for the SA or SED-EA to achieve adequate sensory block measure: Intraoperative blood loss measure: intraoperative muscle tension measure: Extra Lidocaine needed measure: Conversion to GA measure: Total dose of the sedation measure: Hemodynamic stability measured measure: Time to return of motor and sensory function measure: Post-operative nausea measure: PONV and anti-emetics measure: Urinary retention measure: Opioid consumption measure: Length of stay measure: Failed discharded measure: Complications related to the technique performed. measure: Adverse event sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hopital Maisonneuve Rosemont status: RECRUITING city: Montreal state: Quebec zip: H1T 2M4 country: Canada name: Serge Marquis, RN role: CONTACT phone: 5142523400 phoneExt: 5701 email: smarquis.hmr@ssss.gouv.qc.ca name: Janie Barry, MSc role: CONTACT phone: 5142523400 phoneExt: 4567 email: jbarry.hmr@ssss.gouv.qc.ca lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06332430 id: CW-202 briefTitle: Intratumoral CAN2109 in Subjects With Solid Tumors or Lymphomas overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2025-05-30 date: 2026-05-30 date: 2024-03-27 date: 2024-03-27 name: Canwell Biotech Limited class: INDUSTRY briefSummary: A phase 1, dose escalation, open-label study of intratumoral CAN2109 in subjects with unstable or metastatic advanced solid tumors or lymphomas. conditions: Solid Tumor conditions: Lymphoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: CAN2109 measure: Safety and tolerability measure: Recommended Phase 2 Dose (RP2D) measure: To determine the efficacy of CAN2109 measure: To evaluate the pharmacodynamics of CAN2109 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen University Sun Yat-Sen Memorial Hospital city: Guangzhou state: Guangdong zip: 510535 country: China lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06332417 id: REC/RCR&AHS/23/0364 briefTitle: Combined Effects of Ba-Duan-Jin Based Deep Breathing Exercises and Forced Expiratory Technique overallStatus: RECRUITING date: 2024-02-29 date: 2024-06-05 date: 2024-06-15 date: 2024-03-27 date: 2024-03-27 name: Riphah International University class: OTHER briefSummary: This study will be a randomized control trial. A total of 68 patients will be recruited and randomly assign to the experimental group or the control group in a 1:1 ratio. Participants in the experimental group will receive a 8-week Ba-duan jin exercise training intervention along with Forced Expiratory Technique at least 3 days a week and 30 minutes a day, while participants in the control group will be only given Forced Expiratory intervention and will be told to maintain their original lifestyle for 8 weeks along with standard COPD treatment. conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Ba-Duan-Jin Based Deep Breathing Exercises name: FET (Forced Expiratory Technique) measure: 36-Item Short Form Survey (SF-36) measure: FEV1/FVC ratio measure: Exercise Tolerance : 6 minute walk test measure: Forced vital capacity (FVC) measure: Forced expiratory volume (FEV1) sex: ALL minimumAge: 40 Years maximumAge: 55 Years stdAges: ADULT facility: Social Security Teaching Hospital status: RECRUITING city: Lahore state: Punhab zip: 42000 country: Pakistan name: Faisal Rehman, MBBS role: CONTACT phone: +924299230227 email: info@pessi.punjab.gov.pk lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06332404 id: B3002024000047 briefTitle: Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry acronym: B-HNS overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2034-04 date: 2034-04 date: 2024-03-27 date: 2024-03-27 name: University Hospital, Antwerp class: OTHER briefSummary: Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options. Recently, the request for reimbursement of the Inspire system in Belgium was approved.

The aim is to create a registry of OSA patients that are treated with HNS (Inspire system) within routine clinical care at the Antwerp University Hospital. conditions: Obstructive Sleep Apnea conditions: Sleep Apnea conditions: Apnea studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 225 type: ESTIMATED name: Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA) measure: Delta apnea-hypopnea index (AHI) as measured by a polysomnography measure: % of patients that reach treatment success defined by a 50% reduction in AHI and an on therapy AHI of < 20 events/h OR an on therapy AHI of < 15 events/h measure: Therapy adherence defined by the amount of hours therapy usage per night. measure: Delta oxygen desaturation index (ODI) as measured by a polysomnography measure: Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire measure: Disease-specific quality of life as measured by the Functional Outcomes of Sleep Questionnaire-30 (FOSQ-30) questionnaire measure: Degree of snoring measured by the Visual Analogue Scale (VAS) questionnaire sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Antwerp University Hospital city: Edegem state: Antwerp zip: 2650 country: Belgium name: Dorine Van Loo, Msc role: CONTACT phone: +3238215780 email: dorine.vanloo@uza.be name: Olivier Vanderveken, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 51.15662 lon: 4.44504 hasResults: False

 nctId: NCT06332391 id: 202308349 id: R01HL168752 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL168752 briefTitle: Paced Heart Rate Acceleration for Cardiac Conditioning acronym: HeartExcel overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-06-30 date: 2028-11-30 date: 2024-03-27 date: 2024-03-27 name: Denice Hodgson-Zingman, MD class: OTHER name: The Cleveland Clinic name: National Institutes of Health (NIH) name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: A clinical trial of exercise-similar heart rate acceleration delivered via cardiac pacing vs. sham intervention in subjects at rest will be performed. The study population comprises subjects with guideline-directed medically managed severe left ventricular dysfunction due to ischemic or non-ischemic cardiomyopathy and an existing implantable cardioverter defibrillator or biventricular implantable cardioverter defibrillator. The purpose of the study is to understand how the heart rate pattern of exercise contributes to the considerable cardiac conditioning effects of exercise and estimate whether the pacing approach may have translational clinical applicability. Fifty-two subjects will be randomized, single-blinded, to either the pacing intervention or a sham intervention which they will receive once daily, 3 days/week for 6 weeks. Baseline symptoms and clinical test results will be compared to the same measures at 2 weeks, 4 weeks and 6 weeks of intervention/sham and at 3 months and one-year post-intervention. The primary endpoint will be the change in left ventricular ejection fraction from baseline in intervention vs. sham groups (mixed effects linear regression with time and treatment arm as fixed effects and pre-specified covariates of sex and cardiomyopathy type as random effects). Secondary endpoints will include changes in quality of life, 6-minute walk distance, cardiopulmonary exercise test (CPET) measures, daily activity and major adverse cardiac events (MACE) at 3 and 12 months between pacing and sham groups. A "dose-response" analysis of outcomes at 2, 4, and 6 weeks of the intervention vs. sham compared with baseline will be performed. conditions: Heart Failure, Systolic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, single blinded, randomized, controlled trial. Randomization to intervention versus sham groups in a 1:1 ratio. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Subjects and outcomes assessors are blinded to study group (intervention vs. sham) but investigator is not. During intervention vs. sham, subjects do not have access to vital sign data and sham procedures follow intervention procedures exactly with the exception that no change in pacing rate is delivered. A blinding questionnaire is given to subjects to assess adequacy of blinding. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 52 type: ESTIMATED name: Exercise-similar cardiac pacing name: Sham cardiac pacing measure: Change in left ventricular ejection fraction by echocardiogram measure: Quality of Life score on the Minnesota Living with Heart Failure questionnaire measure: Quality of Life score on the Kansas City Cardiomyopathy Questionnaire measure: 6-minute walk distance measure: Cardiopulmonary exercise test maximum oxygen consumption measure: Cardiopulmonary exercise test metabolic equivalents achieved measure: Cardiopulmonary exercise test peak power output achieved measure: Cardiopulmonary exercise test total exercise time measure: daily minutes of sedentary activity measure: daily minutes of low activity measure: daily minutes of moderate activity measure: daily minutes of vigorous activity measure: major adverse cardiac events measure: symptom score during the intervention/sham procedure measure: maximum achieved pacing rate during the intervention/sham procedure measure: presence of significant arrhythmia during the intervention/sham procedure measure: vital signs - systolic blood pressure during the intervention/sham procedure measure: vital signs - oxygen saturation in the blood during the intervention/sham procedure measure: tolerability - vital signs - cardiac output measure: vital signs - cardiac output during the intervention/sham procedure sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06332378 id: sHasan briefTitle: Effect of Exercise Therapy on Type II Diabetic Neuropathic Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2024-08-15 date: 2024-08-15 date: 2024-03-27 date: 2024-03-27 name: Dr. Sobia Hasan class: OTHER briefSummary: The goal of this Randomized control trial (clinical trial) is to learn about the effect of Exercise therapy on Type II Diabetic Neuropathic Patient in Pakistan ,40-70 year's old patient, will be refer by physicians.

Exclusion criteria of the study will lower extremity complications such as fracture, having experience dislocation at least six months prior to the study, having any history of surgical operations in muscles, bones, and joints of lower extremities, suffering from musculoskeletal disorders such as rheumatoid arthritis and myopathy, middle ear and vestibular impairments (patients' self-report), knee joint flexion contracture, and interruption of the intervention sessions for more than two days..

The main question it aims to answer are:

1. To compare the effects of two therapeutic exercises on clinical balance measures on type II diabetic peripheral neuropathy patients.
2. Effectiveness of exercises using Swiss ball in lowering waist circumference, and BMI.
3. Effectiveness of exercises on fasting blood sugar (FBS), post-prandial blood sugar (PPBS), and glycosylated Hemoglobin (HbA1c) among Type II diabetic patients.
4. Effectiveness of exercises on autonomic nervous system activity on type II diabetic peripheral neuropathy patients.

By using random allocation, the participants will divided into three groups: an intervention group (N=30) that receive ball training exercise, another intervention group (N=30) that receive Frenkel training exercise and a control group (N=30).

Each exercise session contain 5 min warm-up (stationary bike), 45 min exercise training (with 1 minute rest for every 5 minutes of exercise), and 5 min of cool down activities including stretching of the muscles involved in balance exercise (gluteal, erector spine, hamstring, rectus femorus, gastro soleus, and pectoral muscles). This make the participants' heart rate stable and prepare their muscles for optimal activity. conditions: Diabetic Neuropathies studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Experimental group 1 :Ball training name: Experimental group 2 :Frenkel Exercises name: Control Group measure: One Leg Stance measure: Berg Balance Scale measure: Timed Up and Go Test: measure: Diabetic Neuropathy Symptom Score measure: Hemoglobin A1C sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06332365 id: ID: 3938/2022 briefTitle: Evaluating Treatment Efficacy in Oral Lichen Planus: The Role of Salivary Biomarkers acronym: salivaLichen overallStatus: COMPLETED date: 2022-01-03 date: 2023-12-15 date: 2024-02-19 date: 2024-03-27 date: 2024-03-27 name: Pia Lopez Jornet class: OTHER briefSummary: Lichen planus, a chronic autoimmune mucocutaneous disorder, affects 0.5% to 2.2% of diverse populations. The treatment for oral lichen planus (OLP) includes a range of options, both topical and systemic therapies. Recent research has highlighted the potential of hyaluronic acid as a drug alternative, potentially offering effective management for OLP and alleviating the discomfort of this chronic condition. The objective was to assess the impact of topical hyaluronic acid on salivary oxidative stress markers in individuals suffering from oral lichen planus conditions: Oral Lichen Planus conditions: Oral Lichen Planus Related Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Randomization: The enrolled subjects were randomly assigned to one of two treatment protocols using a computer-generated table. This method ensures impartial allocation and avoids biases in treatment selection for each patient.

Masking: Medications were prepared and packaged in identical, sealed, and numbered envelopes by the hospital pharmacy and a clinician not involved in the subsequent phases of the study. Each sealed envelope contained the protocol assignment for individual patients and written instructions for the application of the medications. Moreover, clinicians involved in treatment evaluation at each follow-up session were blinded to the treatment assigned to each patient. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ACTUAL name: Acetonide triamcinolone 0.2% +hyaluronicacid 1% name: Corticoid Acetonide triamcinolone 0.2% name: Hyaluronic acid 1% measure: Pain assessment scale measure: OHIP-14 questionnaire measure: reduction of clinical signs measure measure: Salivary level of oxidative stress biomarker sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pia Lopez Jornet city: Murcia zip: 30004 country: Spain lat: 37.98704 lon: -1.13004 hasResults: False

 nctId: NCT06332352 id: 00173470 briefTitle: Intra-articular Platelet-Rich Plasma for Acetabular Labral Tears acronym: PRP for ALT overallStatus: RECRUITING date: 2024-01-25 date: 2025-01-25 date: 2026-01-25 date: 2024-03-27 date: 2024-03-27 name: University of Utah class: OTHER briefSummary: Platelets are small cells found in the blood that help form clots and stop bleeding. Platelet-rich plasma is blood that contains more platelets than normal and can be given to help people with pain. Tears of the Labrum to the hip (the cartilage "suction cup" that holds the ball to the socket of the hip) cause hip pain. The study wants to see if a portion of the patient's blood, the platelets, will help relieve hip pain and function.

Participation requires completing surveys by email, text message, in person, and/or by telephone. Medical tests will also be done to track the health of participants. conditions: Acetabular Labrum Tear studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: PRP measure: Pain & Function Improvements measure: Visual Analog Scale (VAS) measure: Harris Hip Scores (HHS) measure: International Hip Outcome Tool (iHOT-12) measure: EQ-5D (EuroQual 5D) sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Utah - Department of Orthopaedics status: RECRUITING city: Salt Lake City state: Utah zip: 84108 country: United States name: Luke A Johnson, BS role: CONTACT phone: 801-213-3379 email: luke.a.johnson@utah.edu name: Daniel Cushman, MD role: PRINCIPAL_INVESTIGATOR name: Derek Stokes, MD role: SUB_INVESTIGATOR lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06332339 id: HVTN 313 briefTitle: Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 16055 NFL Delta Gly4 Env Protein Trimer and Trimer 4571 Combined With 3M-052-AF + Alum Adjuvant and Ad4-Env145NFL Viral Particles as Heterologous Prime-boost Regimens in Adult Participants Without HIV. overallStatus: RECRUITING date: 2024-04-10 date: 2026-11-11 date: 2026-11-11 date: 2024-03-27 date: 2024-04-03 name: National Institute of Allergy and Infectious Diseases (NIAID) class: NIH briefSummary: The goal of this clinical trial is to test 16055 NFL delta Gly4 Env protein trimer and Trimer 4571 combined with 3M-052-AF + Alum adjuvant and Ad4-Env145NFL viral particles as heterologous prime-boost regimens in adult participants without HIV.

The main question\[s\] it aims to answer are:

* Are these vaccine regimens safe and well tolerated?
* Are the prime-boost vaccine regimens that include Ad4-Env145NFL and Trimer 4571 as heterologous boosts going contribute to the development of B-cell and antibody responses?

Participants will attend scheduled study visits to receive their vaccine and will record symptoms on a daily eDiary. conditions: HIV studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: 16055 NFL delta Gly4 trimer name: Trimer 4571 name: Ad4-Env145NFL, 5 x 108 viral particles (vp) measure: Local reactogenicity signs and symptoms measure: Systemic reactogenicity signs and symptoms measure: Number of adverse events (AEs) reported for 30 days after receipt of any study product measure: Number of Serious Adverse Reactions (SAEs) leading to early participant withdrawal or permanent discontinuation measure: Number of Medically Attended Adverse Event (MAAEs) leading to early participant withdrawal or permanent discontinuation measure: Number of Adverse Events of Special Interest (AESIs) that are Potential Immune Mediated Medical Conditions (PIMMCs) leading to early participant withdrawal or permanent discontinuation measure: Number of Adverse Events (AEs) leading to early participant withdrawal or permanent discontinuation measure: Occurrence of serum IgG binding antibodies to vaccine-matched HIV-1 Env trimers and specific epitopes (e.g., CD4 binding site, V2, base of trimer, etc) measure: Magnitude of serum IgG binding antibodies to vaccine-matched HIV-1 Env trimers and specific epitopes (e.g., CD4 binding site, V2, base of trimer, etc.) measure: Response Rate of serum IgG binding antibodies to vaccine-matched HIV-1 Env trimers and specific epitopes (e.g., CD4 binding site, V2, base of trimer, etc.) measure: Occurrence of serum antibody neutralization of the autologous pseudovirus HIV-1 strains (including vaccine-matched deglycosylated 16055, WT 16055, BG505, 1086) measure: Magnitude of serum antibody neutralization of the autologous pseudovirus HIV-1 strains (including vaccine-matched deglycosylated 16055, WT 16055, BG505, 1086) measure: Response Rate of serum antibody neutralization of the autologous pseudovirus HIV-1 strains (including vaccine-matched deglycosylated 16055, WT 16055, BG505, 1086) measure: Occurrence of serum antibody neutralization of HIV-1 strains measure: Magnitude of serum antibody neutralization of HIV-1 strains measure: Response Rate of serum antibody neutralization of HIV-1 strains measure: Flow cytometry analysis of the frequency of Env-specific IgG+ B cells measure: Occurrence of serum IgG binding antibodies as measured by BAMA measure: Magnitude of serum IgG binding antibodies as measured by BAMA measure: Response Rate of serum IgG binding antibodies as measured by BAMA measure: Number of Isolation of CD4bs bnAb specific VH and VL alleles and characteristic mutations measure: Flow cytometry analysis of the frequency of Env-specific IgG+ B cells at 26 weeks and 52 weeks after the fifth vaccination measure: Occurrence of serum IgG binding antibodies measure: Magnitude of serum IgG binding antibodies measure: Response Rate of serum IgG binding antibodies measure: Occurrence of serum antibody neutralization to tier 2 HIV-1 strains measure: Magnitude of serum antibody neutralization to tier 2 HIV-1 strains measure: Response Rate of serum antibody neutralization to tier 2 HIV-1 strains measure: Epitope specific response rates as measured by electron microscopy polyclonal epitope mapping (EMPEM) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Alabama CRS status: NOT_YET_RECRUITING city: Birmingham state: Alabama zip: 35222 country: United States name: Heather Logan, ANP role: CONTACT phone: 205-873-8686 email: heatherlogan@uabmc.edu lat: 33.52066 lon: -86.80249 facility: The Ponce de Leon Center CRS status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30308 country: United States name: Erika Patrick, MSN role: CONTACT phone: 404-616-6313 email: erpatri@emory.edu lat: 33.749 lon: -84.38798 facility: Brigham and Women's Hospital Vaccine CRS (BWH VCRS) status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Jose Licona, MD role: CONTACT phone: 617-525-9433 email: jlicona@partners.org lat: 42.35843 lon: -71.05977 facility: Columbia Partnership for Prevention and Control of HIV/AIDS CTU status: NOT_YET_RECRUITING city: New York state: New York zip: 10032 country: United States name: Mascha Elskamp role: CONTACT phone: 212-305-2201 email: Me2500@cumc.columbia.edu lat: 40.71427 lon: -74.00597 facility: University of Rochester HIV/AIDS CTU status: NOT_YET_RECRUITING city: Rochester state: New York zip: 14642 country: United States name: Catherine Bunce, RN MS, CCRC role: CONTACT phone: 585-275-5871 email: catherine_bunce@urmc.rochester.edu lat: 43.15478 lon: -77.61556 facility: University of Pennsylvania HIV Therapeutics and Prevention Clinical Trials Unit status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Debora Dunbar, MSN, CRNP role: CONTACT phone: 215-746-3713 email: ddunbar@pennmedicine.upenn.edu lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06332326 id: E-10840098-772.02-4966 briefTitle: Investigation of the Efficacy of Non-Invasive Vagus Nerve Stimulation and Physiotherapy in Unilateral Vestibular Hypofunction Patients overallStatus: RECRUITING date: 2022-10-23 date: 2024-04 date: 2024-05 date: 2024-03-27 date: 2024-03-27 name: Medipol University class: OTHER briefSummary: The purpose of this study: To investigate the effectiveness of non-invasive vagus nerve stimulation and vestibular rehabilitation applications in patients diagnosed with Unilateral Vestibular Hypofunction (UVH). conditions: Vestibular Diseases conditions: Vestibular Vertigo conditions: Vertigo studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 40 patients diagnosed with UHV were included. Patients were randomized into 2 separate groups (20 people in the vestibular rehabilitation group, 20 people in the vagus nerve stimulation group in addition to vestibular rehabilitation). primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: non-invasive vagus nerve stimulation name: vestibular rehabilitation measure: Modified-CTSIB measure: Semitandem test measure: tandem test measure: one-leg standing test measure: Unterberger test measure: VAS Visual Analogue Scale (dizziness severity) measure: Dynamic visual acuity test measure: Dizziness Handicap Inventory Scale measure: Tampa Kinesiophobia Scale measure: Hospital Anxiety and Depression Scale (HAD) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Istanbul Medipol University status: RECRUITING city: Istanbul country: Turkey name: tuğba türk kalkan, MD role: CONTACT phone: +905334956459 email: tugbatrkk@gmail.com name: tugba türk kalkan, MD role: PRINCIPAL_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06332313 id: 2023/10/05 briefTitle: Erector Spina Plane Block Volume Comparison overallStatus: NOT_YET_RECRUITING date: 2024-06-12 date: 2024-11-20 date: 2024-12-05 date: 2024-03-27 date: 2024-03-27 name: Kahramanmaras Sutcu Imam University class: OTHER briefSummary: After obtaining ethical committee approval from Kahramanmaras University Anesthesiology and Reanimation Department and Urology Clinic, 60 patients between 18-65 years old who meet ASA I-II classification criteria with body mass index ≤40 will be informed about this study both verbally and in writing prior to their inclusion in this study using a randomization method according to Helsinki Declaration after obtaining their written consent. Patients who cannot give consent due to any reason or have allergy history against local anesthetics or contraindications for peripheral nerve blocks (local infection,coagulopathy etc.) or psychiatric disorders or receiving antipsychotic drugs will be excluded from this study. Routine preoperative evaluation including age, height, and weight measurements will be performed on all patients at pre-anesthesia clinic.

Patients will be randomized into three groups: Group K, who will receive analgesia with patient-controlled analgesia (PCA) with tramadol only; Group E20, who will receive PCA with 20cc volume of ESP block; and Group E30, who will receive PCA with 30cc volume of ESP block. After standard general anesthesia induction and endotracheal intubation, one of the three analgesic methods will be randomly applied, and the surgery will commence. All patients will receive patient-controlled analgesia. Patients in Group K will not receive any local anesthetic injection. When the patient is transferred to the postoperative care unit, intravenous PCA device will be attached, and pain scores using Visual Analog Scale (VAS), rated from 0 (no pain) to 10 (worst pain ever experienced), at rest and during coughing will be evaluated at 2, 4, 6, 12, 18, and 24 hours postoperatively. The values will be recorded. When the patient experiences pain, analgesic agents will be administered according to the patient-controlled analgesia protocol. The time of first analgesic requirement and total amount of consumed analgesic agent within 24 hours will be recorded. Postoperative QUIPS: Quality Improvement in Postoperative Pain Management questionnaire will be administered, and side effects such as nausea/vomiting or sedation will be noted. Additionally, patient satisfaction regarding these methods and their willingness for repeat surgery or recommendation level on a scale from poor to excellent (very poor/poor/fair/good/excellent)will also be evaluated and recorded conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: erector spina plane block measure: The aim is to observe the difference in tramadol consumption within the first 24 hours after surgery in 3 groups. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06332300 id: ADBL-LC-003 briefTitle: An Exploratory Clinical Study of Adebelimumab in Combination With Famitinib and Chemotherapy in Patients With NSCLC overallStatus: RECRUITING date: 2024-02-01 date: 2025-02-01 date: 2026-02-01 date: 2024-03-27 date: 2024-03-27 name: Jiangsu Province Nanjing Brain Hospital class: OTHER briefSummary: This study was a single-arm design to explore the efficacy and safety of Adebelimumab in combination with famitinib and lateral ventricular chemotherapy in patients with floppy meningeal metastases from non-squamous NSCLC who have failed EGFR-TKI therapy, and included patients with pathologically confirmed non-squamous non-small cell lung cancer. conditions: NSCLC studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Adebelimumab+Famitinib + FOLFIRI+Ariely measure: ORR measure: iPFS measure: iDoR measure: PFS measure: OS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shengcun Fang status: RECRUITING city: Nanjing state: Jiangsu country: China name: Shengcun Fang, PhD role: CONTACT phone: +86 13404163638 email: Fang1984@aliyun.com name: Jian Zhang, Master role: CONTACT phone: +86 13095457871 email: 919939410@qq.com lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06332287 id: 2023-NSCLC briefTitle: A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Advanced NSCLC With Leptomeningeal Metastasis overallStatus: RECRUITING date: 2023-05-01 date: 2024-11-01 date: 2025-06-01 date: 2024-03-27 date: 2024-03-27 name: Jiangsu Province Nanjing Brain Hospital class: OTHER briefSummary: To observe the efficacy of Trilaciclib combined with lateral ventricular chemotherapy in the treatment of non-small cell lung cancer with leptomeningeal metastasis。 conditions: NSCLC studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Trilaciclib primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: combination of Trilaciclib and Pemetrexed measure: Duration of severe neutropenia (DSN) measure: Incidence of Treatment-Emergent Adverse Events measure: Incidence of grade 3 and 4 hematologic toxicity measure: Incidence of G-CSF treatment measure: Incidence of platelet transfusion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fang Shencun status: RECRUITING city: Suzhou state: Jiangsu zip: 210029 country: China name: fang S cun, M.D. role: CONTACT phone: 83728558 phoneExt: 025 email: fang1984@aliyun.com lat: 31.30408 lon: 120.59538 hasResults: False

 nctId: NCT06332274 id: 2023-503316-33-00 id: 2023/3720 type: OTHER domain: CSET number briefTitle: tislelizUMaB in canceR Patients With molEcuLar residuaL Disease acronym: UMBRELLA overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-05 date: 2029-04 date: 2024-03-27 date: 2024-03-27 name: Gustave Roussy, Cancer Campus, Grand Paris class: OTHER name: BeiGene name: C2i Genomics briefSummary: Numerous studies have shown that even when imaging does not reveal the presence of cancer cells, traces of tumor DNA (i.e. originating from cancer cells) can be detected in the blood of certain patients: this is called molecular residual disease (MRD). When such traces are detected (we speak of MRD+ status), the risk of relapse is much higher than when there is no circulating tumor DNA (MRD - status). Given the success of immunotherapy in treating patients with metastatic disease in a variety of tumor types, there is enormous enthusiasm for expanding the use of immunotherapy to people with cancer at an early stage.

UMBRELLA is a biology-driven trial designed to study the impact of systemic treatment with tislelizumab monotherapy after detection of MRD+ status after completion of surgery and perioperative treatments in patients with cancer of a solid tumor. Residual disease (MRD) will be determined by optimized detection and precise monitoring of circulating tumor DNA, enabling early detection of recurrence and disease monitoring, including in patients without MRD \[MRD(-)\]. conditions: Cancer conditions: Lung Cancer conditions: Colo-rectal Cancer conditions: Pancreas Cancer conditions: Soft Tissue Sarcoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a double-blinded, randomized, placebo-controlled, multi-center, national, Phase 3 biology-driven trial designed to investigate the impact of systemic treatment with tislelizumab or placebo following detection of MRD minimum 3 months and maximum 4.5 months after completion of curative-intent therapy. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 717 type: ESTIMATED name: Tislelizumab name: Blood sampling name: Placebo measure: Efficacy of tislelizumab compared to placebo as measured by DFS (Disease-free survival) measure: Estimation of DFS in subjects without MRD measure: Estimation of overall survival (OS) measure: Percentage of MRD (+) subject's completion of standard curative-intent therapy measure: Time between detection of MRD and detection of relapse at imaging. measure: Percentage of subjects with MRD assessment failure. measure: Estimation of the time to become MRD (-) for MRD(+) patients measure: Evaluation of Health-Related Quality of Life (QLQ) by QLQ-C30 measure: Evaluation of Health-Related Quality of Life (QLQ) by EQ-5D-5L measure: Cost effectiveness analysis: incremental cost measure: Cost effectiveness analysis: QALY measure: Cost effectiveness analysis: ICER sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gustave Roussy city: Villejuif state: Val De Marne zip: 94800 country: France lat: 48.7939 lon: 2.35992 hasResults: False

 nctId: NCT06332261 id: 2024-BB-01 briefTitle: Standardized Assessment in Depression Treatment in Routine Psychiatric Services overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-08 date: 2024-04 date: 2024-04 date: 2024-03-27 date: 2024-03-27 name: Karolinska Institutet class: OTHER name: Region Stockholm briefSummary: The goal of this observational study is to evaluate current practices in depression treatment in psychiatric services in Stockholm, Sweden.

The main questions it aims to answer are:

* Are current practices consistent with local clinical guidelines in terms of standardized assessment and the treatments provided?
* What are the present conditions for implementing measurement-based care in depression treatment in this setting?

Data will be collected retrospectively from medical records of patients having received psychological or pharmacological treatment for depression from 2020 to 2023. Frequency of standardized assessments (not scores) using the Montgomery-Åsberg Depression Rating Scale, the Montgomery-Åsberg Depression Rating Scale-Self Assessment, and the Patient Health Questionnaire-9 is collected, together with information on patient, clinician, and treatment characteristics. conditions: Major Depressive Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 4000 type: ESTIMATED measure: Montgomery-Åsberg Depression Rating Scale measure: Montgomery-Åsberg Depression Rating Scale-Self Assessment measure: The Patient Health Questionnaire-9 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stockholm Health Care Services, Region Stockholm city: Stockholm country: Sweden lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06332248 id: 2014/1023-31/4 & 2014/274-31/5 briefTitle: Possible Effects of the Dietary Supplement Magnesium Compared to Placebo overallStatus: COMPLETED date: 2014-09-15 date: 2015-05-20 date: 2015-05-28 date: 2024-03-27 date: 2024-03-27 name: Dan Hasson class: OTHER name: Stiftelsen Stressmottagningen name: AFA Insurance briefSummary: The goal of this clinical trial was to investigate possible outcomes of the nutritional supplement magnesium compared to placebo in healthy, working adults. The main questions it aimed to answer were:

* Are there differences in ratings of health, stress, well-being and work environment indicators between individuals intaking 375 mg magnesium (daily for 3 months) compared to placebo?
* Are there differences in hearing, measured with hearing tests between those receiving 375 mg magnesium compared to placebo?

Participants were asked to ingest 375 mg magnesium or placebo daily for 3 months.

Researchers compared the group ingesting magnesium with the group ingesting placebo pills to see if there were any differences in for example self-rated health, recovery, wellbeing, etc. conditions: Health Promotion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants received either 375 mg nutritional supplement magnesium or placebo pill. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1013 type: ACTUAL name: Magnesium name: Placebo measure: Time x group difference in HealthWatch-11 (questionnaire) measure: Intervention compliance measure 1 (objective, number of pills left) measure: Intervention compliance measure 2 (subjective, marked days in calendar) measure: Time x group difference in Oldenburg Burnout Inventory (questionnaire) measure: Time x group difference in Karolinska Sleep Questionnaire measure: Time x group difference in Pure Tone Audiogram (clinical hearing test) measure: Time x group difference in Speech in noise test (clinical hearing test) measure: Time x group difference in Uncomfortable loudness level (clinical hearing test) measure: Time x group difference in single questionnaire item assessing sick leave measure: Time x group difference in single questionnaire item assessing sickness presenteeism measure: Time x group difference in prevalence of pain (questionnaire) measure: Time x group difference in pain frequency (questionnaire) measure: Time x group difference in pain discomfort (questionnaire) measure: Time x group difference in pain intensity (questionnaire) measure: Time x group difference in functional impairment due to pain (questionnaire) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06332235 id: KMUHIRB-F(I)-20220023 briefTitle: Efficacy and Safety of Silodosin in the Treatment of Lower Urinary Tract Symptoms in Taiwanese Population. overallStatus: RECRUITING date: 2022-02-18 date: 2024-09-30 date: 2024-12-31 date: 2024-03-27 date: 2024-03-27 name: Kaohsiung Medical University Chung-Ho Memorial Hospital class: OTHER briefSummary: To evaluate the therapeutic effects and safety of silodosin in the patients of acute brain injury with lower urinary tract symptoms. conditions: Human Trichinellosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 70 type: ESTIMATED name: Silodosin 8 mg measure: Assessment criteria Efficacy measure: Assessment criteria Safety measure: Assessment criteria Efficacy sex: ALL minimumAge: 20 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kaohsiung Medical University Chung-Ho Memorial Hospital status: RECRUITING city: Kaohsiung state: Sanmin District zip: 807 country: Taiwan name: Chen Yu Chen, MS role: CONTACT phone: 0911884597 email: jennis7995@hotmail.com lat: 22.61626 lon: 120.31333 hasResults: False

 nctId: NCT06332222 id: 1987 briefTitle: Recovery With Tart Cherry Supplementation Following a Marathon. overallStatus: COMPLETED date: 2023-04-01 date: 2023-10-11 date: 2023-10-11 date: 2024-03-27 date: 2024-03-27 name: Northumbria University class: OTHER name: Iprona Lana SpA briefSummary: The goal of this clinical trial is to compare recovery in healthy, active runners.

The main questions it aimed to answer were whether 7 day supplementation with Vistula TC attenuated:

* muscle function
* inflammation
* soreness following a marathon run.

Participants will either consume a spray-dried tart cherry supplement or a calorie-matched placebo-control for 7 days, and complete a marathon. Participants will perform functional tests, be assessed for their perceptual recovery and markers of inflammation and muscle damage via:

* maximal voluntary contractions
* counter movement jumps
* visual analog scales to assess soreness
* blood samples conditions: Exercise Recovery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 35 type: ACTUAL name: Tart Cherry name: Placebo measure: Maximal Voluntary Contraction measure: Counter Movement Jump measure: Active Muscle Soreness measure: Serum Concentration of High-Sensitive C-Reactive Protein measure: Serum Concentration of Creatine Kinase measure: Perceptual Measures sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northumbria University city: Newcastle Upon Tyne state: Tyne And Wear zip: NE1 8ST country: United Kingdom lat: 54.97328 lon: -1.61396 hasResults: False

 nctId: NCT06332209 id: Pro00135303 id: U66RH31458 type: OTHER_GRANT domain: Telehealth Center of Excellence briefTitle: Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-09-30 date: 2025-09-30 date: 2024-03-27 date: 2024-03-29 name: Medical University of South Carolina class: OTHER briefSummary: The current study will evaluate TF-CBT delivered via tele-health for youth presenting with trauma symptoms via a randomized controlled trial. Goals of the current study are to examine the effectiveness of Tele-TF-CBT delivered by community providers in Puerto Rico in improving youth trauma outcomes. Goals are also to support the feasibility, acceptability, and engagement outcomes of Tele-health delivery. conditions: Post-Traumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Trauma Focused Cognitive Behavioral Therapy measure: Traumatic Stress Symptoms measure: Traumatic Stress Symptoms measure: Anxiety and Depression Symptoms measure: Anxiety and Depression Symptoms sex: ALL minimumAge: 7 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06332196 id: L-IEI briefTitle: Immunodeficiency and Cancer: Identification of Congenital Immune System Defects Underlying Paediatric Lymphomas overallStatus: RECRUITING date: 2023-10-18 date: 2025-06-18 date: 2025-10-18 date: 2024-03-27 date: 2024-03-27 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Inborn Errors of Immunity (IEI) are a heterogeneous group of disorders characterised not only by an infectious diathesis, but by a wide variety of other clinical manifestations. Lymphoma is one of the most common malignancies in children and may be the first clinical manifestation of IEI, thereby 'hiding' the immune defect and delaying genetic/immunological diagnosis. Lymphomas, especially non-Hodgkin's lymphomas (NHL) are frequently associated with congenital defects of the immune system, in particular diffuse large B-cell lymphoma and Burkitt's lymphoma. Preliminary analyses conducted on 6 patients diagnosed with NHL allowed the identification of genetic variants in genes associated with IEI. In clinical practice, the diagnosis and choice of therapeutic treatment in patients with immunodeficiency-associated lymphoma are decisive and, due to the complex pathophysiology of the disease, it is not always possible to identify the boundary between benign and malignant proliferation. The identification of an undiagnosed immunodeficiency in patients with lymphoma will ensure the opportunity to apply targeted therapies, such as allogeneic haematopoietic stem cell transplantation, instead of standard clinical management based mainly on chemotherapy. The study aims to identify possible congenital defects of immunity, i.e. genetic disorders affecting the immune system, as responsible for the development of haematological malignancies. Through a multidisciplinary approach involving immunological analyses, genetic analyses and a thorough examination of clinical manifestations, we aim to characterise the immunological component underlying the development of paediatric lymphomas. conditions: Immune Deficiency studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients diagnosed with non-Hodgkin's lymphoma (NHL) or Hodgkin's lymphoma (HL) aged and patients with previous lymphoma and signs of immunodeficiency primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: Analysis of biological sample and clinical data measure: To unravel inborn error of immunity behind Lymphoid neoplasm in children measure: Identification of lymphoma-specific biomarkers sex: ALL minimumAge: 1 Day maximumAge: 24 Years stdAges: CHILD stdAges: ADULT facility: AOU Malpighi IRCCS status: ACTIVE_NOT_RECRUITING city: Bologna country: Italy lat: 44.49381 lon: 11.33875 facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence country: Italy name: Eleonora Gambineri role: CONTACT email: eleonora.gambineri@meyer.it lat: 43.77925 lon: 11.24626 facility: AOU Pisana status: ACTIVE_NOT_RECRUITING city: Pisa country: Italy lat: 43.70853 lon: 10.4036 facility: Ospedale Pediatrico Bambin Gesù IRCCS status: ACTIVE_NOT_RECRUITING city: Roma country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06332183 id: ECDGWAS briefTitle: GWAS and EWAS in Patients With Erdheim-Chester Disease overallStatus: RECRUITING date: 2019-07-17 date: 2024-07-01 date: 2024-10-01 date: 2024-03-27 date: 2024-03-27 name: Augusto Vaglio class: OTHER briefSummary: Erdheim-Chester Disease (ECD) is a rare form of histiocytosis characterized by the proliferation of blood cells, known as histiocytes, which infiltrate various organs and tissues, often causing irreversible damage. The causes of the condition are still unknown, and although some mutations in genes involved in cell proliferation have been identified, other factors may be involved. Susceptibility to developing rare diseases like ECD is typically associated with genetic factors, including DNA polymorphisms and epigenetic modifications.

This study aims to analyze the entire genome of a large cohort of patients with ECD and healthy controls to determine whether there are polymorphisms and epigenetic variants associated with susceptibility to developing the disease. The study could thus clarify the genetic predisposition to ECD development, provide insights into disease pathogenic mechanisms, and identify proteins or cellular mechanisms potentially targeted by specific treatments. conditions: Erdheim-Chester Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Presence of polymorphisms measure: Polymorphisms and genetic variants correlated with disease development measure: Methylation in Erdheim-Chester disease measure: Gene expression in Erdheim-Chester disease sex: ALL minimumAge: 1 Year maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hopital Pitié Salpetrière status: RECRUITING city: Paris country: France name: Julien Haroche role: CONTACT lat: 48.85341 lon: 2.3488 facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence country: Italy name: Augusto Vaglio role: CONTACT email: augusto.vaglio@meyer.it lat: 43.77925 lon: 11.24626 facility: IRCCS Ospedale San Raffaele status: RECRUITING city: Milano country: Italy name: Lorenzo Dagna role: CONTACT lat: 45.46427 lon: 9.18951 facility: AOU Parma status: RECRUITING city: Parma country: Italy name: Davide Martorana role: CONTACT lat: 44.79935 lon: 10.32618 facility: Genetics Lab, CSIC status: RECRUITING city: Granada country: Spain name: Javier Martin role: CONTACT lat: 37.18817 lon: -3.60667 hasResults: False

 nctId: NCT06332170 id: HS-20093-103 briefTitle: ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2026-05-30 date: 2028-05-30 date: 2024-03-27 date: 2024-03-27 name: Hansoh BioMedical R&D Company class: INDUSTRY briefSummary: HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents in patients with advanced solid tumor patients. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 610 type: ESTIMATED name: HS-20093 name: Adebrelimab name: Cisplatin/ Carboplatin name: Cetuximab name: Enzalutamide measure: Maximum tolerated dose (MTD) for combination-treatments measure: Incidence and severity of adverse events (AEs) measure: Objective response rate (ORR) determined by investigators measure: Disease control rate (DCR) determined by investigators measure: Duration of response (DoR) determined by investigators measure: Progression-free survival (PFS) determined by investigators according to RECIST 1.1 measure: Overall survival (OS) measure: Radiographic progression-free survival (rPFS) determined by investigators according to RECIST 1.1 and PCWG3 measure: Time to PSA progression (TTPP) measure: Prostate-specific cancer antigen (PSA) response rate measure: Time to first subsequent therapy (TFST) measure: Observed maximum plasma concentration (Cmax) of HS-20093advanced solid tumor measure: Time to reach maximum plasma concentration (Tmax) of HS-20093 measure: Terminal half-life (T1/2) of HS-20093 following the first dose measure: Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20093 measure: Percentage of participants with antibodies to HS-20093 in serum sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06332157 id: 2023-ke-715-1 briefTitle: Postoperative Quality of Recovery After General Anesthesia With Remimazolam overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2025-12 date: 2024-03-27 date: 2024-03-27 name: Beijing Chao Yang Hospital class: OTHER briefSummary: 126 patients undergoing general anesthesia for elective surgery in Beijing Chaoyang Hospital were selected. In the intervention group, anesthesia was induced with remimazolam besylate at a rate of 6mg/min; Anesthesia was maintained with 1.0-2.0mg/min remimazolam besylate by continuous pump. Control group: anesthesia induction, intravenous injection of propofol 2mg/kg; Anesthesia was maintained by continuous pumping of 6-8mg/kg/h propofol. All patients were routinely monitored for vital signs and anesthesia depth after entering the operating room. The patients were followed up after surgery, and the quality of recovery score at 24 hours after surgery was the main study outcome. conditions: Anesthesia Recovery Period studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 126 type: ESTIMATED name: Remimazolam besylate name: Propofol Injection Emulsion measure: 15-item quality of recovery scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06332144 id: 1R56DC020208-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R56DC020208-01A1 briefTitle: Predicting Language and Literacy Growth in Children With ASD Using Statistical Learning acronym: PLAUSL overallStatus: RECRUITING date: 2024-01-13 date: 2024-08-31 date: 2024-08-31 date: 2024-03-27 date: 2024-03-27 name: Northeastern University class: OTHER name: University of Delaware name: Boston University name: Cornell University briefSummary: The goal of this observational study is to test a reciprocal relationship between statistical learning and the development of language and literacy in first-graders with autism and their non-autistic peers. The main questions it aims to answer are:

1. whether children's statistical learning abilities can predict their long-term improvement of language and literacy skills in school;
2. how children's brains automatically learn patterns from speech and prints;
3. whether children's learning in the lab reflects the language patterns they have learned over the years from their native language.

First-grade students will participate in the study twice across three months.

During Time 1, children will complete

* a battery of language, reading, and cognitive assessments
* a series of computer-based statistical learning games both inside and outside of functional MRI scanner.

During Time 2, children will complete a battery of language and reading assessments to detect the growth in three months.

Researchers will compare the autistic and the non-autistic groups to see if statistical learning plays a similar or different role in predicting children's language and literacy growth. conditions: Autism Spectrum Disorder conditions: Language Development conditions: Literacy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Structural vs. Random sequences of stimuli name: Intact vs. Degraded speech name: Repeating 5-syllable nonwords or 2-syllable nonwords name: Recall letter or syllable strings that either contain highly frequent bigram/trigram items or infrequent items according to English Corpus data. measure: Language Composite Score measure: Reading Composite Score measure: Language/Literacy Disorder Status measure: Neural similarity between language and statistical learning tasks measure: Orthographic statistical sensitivity measure: Phonological statistical sensitivity measure: Linguistic SL composite scores measure: Neural sensitivity to statistical regularities during the statistical learning tasks measure: Neural activation to statistical regularities during the language tasks sex: ALL minimumAge: 72 Months maximumAge: 90 Months stdAges: CHILD facility: Northeastern University status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Brynn Siles, BS role: CONTACT phone: 617-830-1530 email: plausl.project@gmail.com name: Zhenghan Qi, MD/PhD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Boston University status: ENROLLING_BY_INVITATION city: Boston state: Massachusetts zip: 02215 country: United States lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06332131 id: UPCC07623 briefTitle: Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-03-27 date: 2024-04-10 name: Abramson Cancer Center at Penn Medicine class: OTHER briefSummary: This is an observational study that includes patients with melanoma who will be treated with adjuvant immune checkpoint inhibitor (ICI) therapy. The investigators will use echocardiograms, blood draws, and PET stress tests to understand how ICI therapy affects the heart and circulatory system. conditions: Melanoma conditions: Coronary Microvascular Dysfunction conditions: Cardiotoxicity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 25 type: ESTIMATED measure: Incidence of new abnormal myocardial blood flow reserve (MBFR) measure: Incidence of major cardiovascular events measure: Coronary calcium score measure: All cause mortality measure: Cardiovascular specific mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Abramson Cancer Center at University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19104 country: United States lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06332118 id: avf ice massage briefTitle: The Effect of Ice Massage on Pain, Ecchymosis, Hematoma and Patient Satisfaction overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05-15 date: 2024-05-30 date: 2024-03-27 date: 2024-04-02 name: Erzurum Technical University class: OTHER briefSummary: The research was planned to measure pain, ecchymosis, hematoma and patient satisfaction with ice massage applied to the fistula before the arteriovenous fistula procedure in hemodialysis patients. Patients who agree to participate in the study will be given ice massage before the procedure and the relevant parameters will be measured. conditions: Hemodialysis Complication studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The research is quasi-experimental and relationship-seeking in a pretest-posttest format. primaryPurpose: PREVENTION masking: NONE count: 35 type: ESTIMATED name: ice massage group measure: Pain score measure: Ecchymosis degree measure: Hematoma degree measure: Patient satisfaction score sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ercan Bakır city: Erzurum state: Yakutiye zip: 25010 country: Turkey name: Ercan Bakır, PhD role: CONTACT phone: 05444252111 email: ercan.bakir@erzurum.edu.tr name: Ercan Bakır, PhD role: CONTACT phone: 05443047186 email: e.bakir02@gmail.com lat: 39.90861 lon: 41.27694 facility: Ercan Bakır city: Erzurum state: Yakutiye country: Turkey lat: 39.90861 lon: 41.27694 hasResults: False

 nctId: NCT06332105 id: CUK001 briefTitle: Evaluation of Low Phenylalanine Formulas overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-30 date: 2025-01 date: 2025-04 date: 2024-03-27 date: 2024-04-15 name: Ajinomoto Co., Inc. class: INDUSTRY name: Birmingham Children's Hospital name: Great Ormond Street Hospital for Children NHS Foundation Trust briefSummary: Ajinomoto Cambrooke has developed a PKU protein substitute that is a proprietary blend of purified Glycomacropeptide (GMP) and essential amino acids, under the brand name Glytactin®. One serving of such Glytactin® products contains 20mg or less of Phenylalanine (Phe). The aim of the proposed study is to use this purified GMP-AA-based protein substitute, with less Phe per gram of protein equivalent than other commercially available products, in children with PKU at 100% of their protein substitute intake and evaluate its efficacy and the change in blood Phe in comparison to Phe-free L-AA-based protein substitutes. conditions: Phenylketonurias studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: 2-stage, 15-week randomized crossover trial. primaryPurpose: TREATMENT masking: NONE count: 19 type: ESTIMATED name: Glytactin name: L-AA measure: Change in blood Phe in sex: ALL minimumAge: 3 Years maximumAge: 16 Years stdAges: CHILD facility: Birmingham Women and Children's Hospital city: Birmingham state: West Midlands zip: B4 6NH country: United Kingdom lat: 52.48142 lon: -1.89983 facility: Great Ormond Street Hospital for Children city: London zip: WC1N 3JH country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06332092 id: FID-007-003 briefTitle: FID-007 and Cetuximab in Treating Patients With Advanced Head and Neck Squamous Cell Carcinoma acronym: HNSCC overallStatus: RECRUITING date: 2024-04-10 date: 2025-03-31 date: 2025-12-31 date: 2024-03-27 date: 2024-04-17 name: Fulgent Pharma LLC. class: INDUSTRY briefSummary: The goal of this FID-007 Clinical Trial is to compare the efficacy of different dosing regimens of FID-007 in combination with Cetuximab in patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). The main questions it aims to answer are: to evaluate the efficacy, and to characterize the safety and tolerability. Eligible participants will be enrolled and randomized to 1 of 2 arms of FID-007 with fixed-dose Cetuximab in each 28-day cycle. conditions: Head and Neck Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Two different dosing regimens of FID-007 in combination with fixed-dose Cetuximab primaryPurpose: TREATMENT masking: NONE count: 46 type: ESTIMATED name: FID007 measure: ORR assessed by Response Evaluation Criteria in Solid Tumors (RECIST) measure: BOR assessed by Response Evaluation Criteria in Solid Tumors (RECIST) measure: Duration of Response (DoR) measurement measure: Progression-free Survival (PFS) measurement measure: Overall Survival (OS) measurement measure: Disease Control Rate (DCR) analysis measure: Adverse Events (AEs) graded according to the CTCAE version 5.0 measure: Vital Signs safety assessments measure: Clinical Laboratory safety assessments measure: ECGs safety assessment measure: Area Under the Plasma Concentration Versus Time Curve (AUC) of FID-007 measure: Peak Plasma Concentration (Cmax) measure: Terminal/elimination half-life (t1/2) measure: Clearance (CL) measure: Volume of Distribution (Vd) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gabrail Cancer Center Research status: RECRUITING city: Canton state: Ohio zip: 44718 country: United States name: Nashat Gabrail, MD role: CONTACT lat: 40.79895 lon: -81.37845 hasResults: False

 nctId: NCT06332079 id: HAITI 2023-505356-22-00 briefTitle: Holmium-166 TARE in Liver Limited Unresectable Colorectal Cancer Patients acronym: HAITI overallStatus: RECRUITING date: 2024-03-13 date: 2026-11 date: 2027-02 date: 2024-03-27 date: 2024-03-27 name: Gruppo Oncologico del Nord-Ovest class: OTHER briefSummary: The aim of this study is to assess the efficacy of 166Ho-TARE followed by maintenance therapy with fluoropyrimidine and anti-EGFR or bevacizumab in liver-limited unresectable colorectal cancer patients, in terms of progression free rate 9- and 8-months for cohort A and B, respectively. conditions: Colorectal Cancer Metastatic studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Two cohorts of patients will be included according to the two main prognostic populations in mCRC (left sided, RAS/BRAF wild-type and, right-sided and/or RAS mutated tumors) treated with different maintenance therapy (fluoropyrimidine plus anti-EGFR or bevacizumab).

A total of 23 patients will be enrolled in each cohort. primaryPurpose: TREATMENT masking: NONE count: 46 type: ESTIMATED name: 166Holmium TARE name: Cetuximab name: Panitumumab name: 5-Fluorouracil name: Bevacizumab name: Capecitabine measure: Progression-free survival (PFS) Rate measure: Overall Toxicity rate measure: Grade 3/ Grade 4 Toxicity rate measure: Post-treatment Disease Control Rate (DCR) measure: Progression free survival measure: Overall Survival measure: Dose-response relationships measure: Quality of Life (QoL) assessed using the EORTC QLQ-CR29 questionnaire measure: Quality of Life (QoL) assessed using the EORTC QLQ-CR30 questionnaire measure: Quality of Life (QoL) assessed using the EuroQol EQ-5D questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliero Universitaria Pisana status: RECRUITING city: Pisa zip: 56126 country: Italy name: Beatrice Borelli, MD, PhD role: CONTACT phone: +39050992192 email: b.borelli89@gmail.com name: Gianluca Masi, MD role: PRINCIPAL_INVESTIGATOR name: Beatrice Borelli, MD, PhD role: SUB_INVESTIGATOR lat: 43.70853 lon: 10.4036 hasResults: False

 nctId: NCT06332066 id: 0046-24-COM briefTitle: Oxytocin Administration to Therapists and Its Effects on Patient-perceived Attunement and Responsiveness overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-05-30 date: 2024-06-30 date: 2024-03-27 date: 2024-03-27 name: Shalvata Mental Health Center class: OTHER name: Clalit Health Services briefSummary: In recent years there is a great interest in the possible role of Oxytocin (OT) as a facilitator for enhancing psychotherapeutic processes in patients with mental illnesses. Specific studies explored OT administration to patients, and the effect on psychotherapy on interaction within the therapeutic dyad. Nonetheless, studies exploring OT's effects of the therapists' side of the therapeutic dyad on the psychotherapy session and outcome, have not been conducted. The current study aims to assess the effect of OT administration to the therapists of psychiatric outpatients, on treatment process and outcome and specifically on the patient and therapist experience of the attunement and responsiveness toward the patient in the therapeutic encounter. Twenty staff members from Teradion Mental health Clinic of Clalit Health Services will be recruited, as well as 100 patients treated by these staff members. Therapists agreeing to participate will receive OT and PLC in a random order, at the same day they are seeing the same patients and the consecutive week. Patients agreeing to participate will complete a demographic questionnaire and all study measures, and will be scheduled to perform two consecutive research sessions with their therapists. The therapist will receive either OT or PLC in each of these two sessions, and right after the session the patients will complete the assessment scales. Multilevel models will be performed by the investigators to assess the effects of OT administration in therapists receiving OT versus receiving placebo. This research will be performed in accordance with ethical principles of Helsinki WMA Declaration. This study is the first to assess the effectiveness of hormonal augmentation for therapists and its influence on therapeutic process with patients suffering from acute distress in the public mental health domain. conditions: Mental Health Therapists studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Oxytocin nasal spray measure: Attunement and Responsiveness towards patients measure: Attachment with Therapist measure: Working Alliance with Therapist measure: Patient Symptoms sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mental Health Clinic, Teradion city: Misgav country: Israel name: Ayelet Nir,, M.A. role: CONTACT phone: 972-4-6025050 email: ayeletni1@clalit.org.il name: Galit role: CONTACT phone: 972-4-6026050 lat: 32.86017 lon: 35.26165 hasResults: False

 nctId: NCT06332053 id: SY-5007-I-03 briefTitle: A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of SY-5007 in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-06-01 date: 2024-03-27 date: 2024-03-27 name: Shouyao Holdings (Beijing) Co. LTD class: OTHER briefSummary: This study is a single-center, open-lable and fixed sequence test conducted in healthy subjects to evaluate the pharmacokinetic effects of Itraconazole and Rifampicin on a single dose of SY-5007 Oral administration. It is planned to enroll 28 healthy subjects and assign them to two parallel test groups, Group A (SY-5007 combined with Itraconazole) and Group B (SY-5007 combined with Rifampicin). conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: SY-5007 name: Itraconazole name: SY-5007 name: Rifampin measure: Cmax for SY-5007 measure: Tmax for SY-5007 measure: AUC0-t for SY-5007 measure: AUC0-∞ for SY-5007 measure: t½ for SY-5007 measure: CL/F for SY-5007 measure: Vz/F for SY-5007 measure: Safety of SY-5007 sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: West China Hospital of Sichuan University city: Chengdu state: Sichuan zip: 610041 country: China name: Li Zheng role: CONTACT phone: 86-28-85423655 email: zhengli@wchscu.cn lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06332040 id: 22-500-243-50-35 briefTitle: Gentamicin Bladder Instillation on CAUTI overallStatus: RECRUITING date: 2023-10-09 date: 2026-10-08 date: 2026-10-08 date: 2024-03-26 date: 2024-03-26 name: St. Joseph's Hospital and Medical Center, Phoenix class: OTHER briefSummary: Urinary tract infections in catheterized patients is an unacceptable complication and has been termed a 'never event' by the Center for Medicare \& Medicaid Services (CMS); however there is not consensus among clinicians on how to best prevent CAUTIs. We propose a prospective randomized controlled trial to test the efficacy of prophylactic gentamicin bladder irrigation in elimination of CAUTIs. conditions: Catheter Infection studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 400 type: ESTIMATED name: Gentamicin measure: CAUTI as primary outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Jpseph's Hospital and Medical Center status: RECRUITING city: Phoenix state: Arizona zip: 85013 country: United States name: Kristina Kupanoff, PhD role: CONTACT phone: 602-406-5192 email: Kristina.Kupanoff@Commonspirit.org lat: 33.44838 lon: -112.07404 hasResults: False

 nctId: NCT06332027 id: Soh-Med-24-03-03MD briefTitle: Accuracy of Hystro-Salpingo-Foam-Sonography (HYFOSY) as Tubal Patency Test in Comparison to Laparoscopy in Infertile Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-03-26 date: 2024-03-26 name: Sohag University class: OTHER briefSummary: Tubal patency testing is an essential part of female subfertility evaluation . Tubal abnormalities are seen in 30-40% of female subfertility patients . Laparoscopy with chromopertubation is considered to be the gold standard diagnostic procedure .

Laparoscopy is an invasive test, with a risk of intra-abdominal bleeding, visceral damage, and risks related to general anaesthesia.

Traditionally, Hysterosalpingography(HSG) is a less invasive less expensive first-step alternative, which has been used for decades with disadvantages such as radiation exposure, discomfort, or even abdominal pain.

Hysterosalpingo-Contrast Sonography (HyCoSy) was introduced as an alternative using either contrast media or saline. The accuracy of HyCoSy is comparable to that of HSG and LSC being reference standards for tubal patency testing.However, hyperechogenic contrast media such as Echovist_ (Schering AG, Berlin) and SonoVue_ (Bracco, Milan)are either no longer available or not licensed for tubal patency testing.

Hysterosalpingo-Foam Sonography (HyFoSy) was developed as an alternative for contrast HyCoSy and was introduced in 2010 as a first-line office tubal patency test.Foam is used in the HyFoSy technique to visualize the fallopian tubes and is created by rigorously mixing 5mlExEm_-gel (containing hydroxyethyl cellulose and glycerol,IQMedical Ventures BV, Rotterdam, TheNetherlands) with 5ml purified ExEm_-water.

The ExEm_-foam is sufficiently fluid to pass the fallopian tubes and in the mean time sufficiently stable to show echogenicity for at least five minutes, which is an advantage over saline. In a review on safety aspects and side effects of ExEm-gel it was considered to be appropriate and safe for tubal patency testing.

In 2017, HyLiFoSy combined with power Doppler (PD)(HyLiFoSy-PD) technique was described as a possibly less painful and easier to detect on ultrasound alternativeto HyFoSy and HyCoSy, which can be used whenever the contrast media used with both are either unavailable or is relatively expensive Ultrasound-based tubal patency tests include hysterosalpingo-contrast sonography (HyCoSy), hysterosalpingo-foam sonography (HyFoSy), and hysterosalpingo-lidocaine-foam sonography (HyLiFoSy)and have shown a high detection rate of tubal obstruction and good reproducibility with concordances from 83.8 to 100% with HSG, and from 78.1 to96.91% with lap-and-dye test.

In addition, they allow for a single comprehensive assessment of the uterus and the fallopian tubes and it can be performed by the same specialist who indicates it, in the clinician's own office with it consequently being time efficient. Finally, some studies have shown an increase in the rate of post-procedure gestation. conditions: Infertility, Female studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 122 type: ESTIMATED name: Hystro-Salpingo-Foam-Sonography (HYFOSY) measure: the accuracy of HyFoSy in the assessment of tubal patency sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Sohag University Hospital city: Sohag country: Egypt name: Magdy M Amin, Professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06332014 id: 20210123 briefTitle: Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2026-07-29 date: 2026-07-29 date: 2024-03-26 date: 2024-03-26 name: Amgen class: INDUSTRY briefSummary: The primary objective of this study is to evaluate the efficacy of Prolia on lumbar spine BMD at 12 months. conditions: Osteoporosis studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Prolia measure: Percent change from baseline in bone mineral density (BMD) of lumbar spine at month 12 measure: Percent change from baseline in serum C-terminal telopeptide (CTx) at month 3, 6, 9, and 12 measure: Percent change from baseline in serum procollagen Type 1 N-Telopeptide (P1NP) at month 3, 6, 9, and 12 measure: Percent change from baseline in total hip and femoral neck BMD at month 6 and 12 measure: Percent change from baseline in lumbar spine BMD at month 6 measure: Number of participants with adverse events (AE) sex: MALE minimumAge: 30 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06332001 id: IEO 1403 briefTitle: Evaluation of a Music and Interaction Intervention on Patient Distress During Whole Body Magnetic Resonance overallStatus: RECRUITING date: 2020-12-31 date: 2024-12-31 date: 2024-12-31 date: 2024-03-26 date: 2024-03-26 name: European Institute of Oncology class: OTHER briefSummary: This is a randomized controlled trial for the evaluation of the acceptability of Whole-Body-Magnetic Resonance Imaging (WB-MRI) based on music and comunication intervention compared to a standard care condition.

Subjects will be randomized into two groups: the experimental group or arm that receives the music and interaction interventions, and the control group or arm that receives a standard care condition. conditions: Neoplasm Malignant studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Experimental Group name: Control Group measure: Acceptability of WB-MRI based on music and comunication intervention compared to a standard care condition. measure: Measure the level of patient's distress pre and post WB-MRI in the two groups using Distress Thermometer (V2.2020) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IEO Istituto Europeo di Oncologia status: RECRUITING city: Milan zip: 20141 country: Italy name: Giuseppe Petralia role: CONTACT email: giuseppe.petralia@ieo.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06331988 id: IEO 1341 briefTitle: Microbiome, Immune-system and Tumor Interaction in Colorectal Cancer acronym: MITICO overallStatus: RECRUITING date: 2022-07-21 date: 2026-07-31 date: 2029-07-31 date: 2024-03-26 date: 2024-03-27 name: European Institute of Oncology class: OTHER briefSummary: Colorectal cancers represent the second leading cause of cancer-related death in the United States Western world. In Italy they represent the second most frequent neoplasm (49,000 cases in 2019). Despite the advancement of surgical techniques and medical therapy programs systemic, it is estimated that approximately 40-50% of colorectal cancers recur after being treated for a limited loco-regional disease. Patients who develop metastases throughout their history clinic have a 5-year overall survival of just over 10%.

Adjuvant systemic chemotherapy can reduce the risk of disease recurrence in patients with colorectal adenocarcinomas, however, the standard drugs used to date for this use (fluoropyrimidines and oxaliplatin) have not undergone substantial changes in the last 20 years or so.

A crucial point is the need to have more precise information regarding risk factors above all biomolecular to base therapeutic choices.

It has now become urgent to overcome the T-tumor N-node M- metastasis (TNM) staging, to have more modern knowledge on the factors capable of impacting significantly on the prognosis, influence the real risk of disease recurrence, Identify new prognostic categories and subcategories, therefore being able to predict the clinical benefit of treatments that can be more targeted, personalized and effective. In this panorama it has developed in recent years an ever-growing literature also regarding the role of bacterial flora intestinal (microbiota) in patients with colorectal cancer. In particular, recent discoveries have highlighted the immunoregulatory role of the microbiota in the anti-tumor response. This study aims of evaluating how the molecular characteristics of the tumor, of the infiltrating immune system cells and of the associated intestinal microbiota correlate with the development of colorectal cancer, its progression and response to treatments. conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 320 type: ESTIMATED measure: Relapse free survival measure: Overall survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan zip: 20141 country: Italy name: Davide Ciardiello, MD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06331975 id: IEO 0836 briefTitle: Radiomics and Radiogenomics of Non-small Cell Lung Cancer overallStatus: COMPLETED date: 2018-06-12 date: 2023-01-31 date: 2023-09-14 date: 2024-03-26 date: 2024-03-26 name: European Institute of Oncology class: OTHER briefSummary: In this study, the radiomic characteristics and a broad range of genetic aberrations in lung adenocarcinomas will be evaluated. Investigators will assess changes in the radiomic and genetic profiles during targeted therapies in a subset of patients harboring treatable mutations. Patients undergoing targeted therapies will also be evaluated for variations in genomic profile and radiomic signature during follow-up conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 91 type: ACTUAL name: Radiomic signature measure: Evaluation of the association between the status of Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), Kirsten Rat Sarcoma Virus (KRAS) and nodal status measure: Evaluation of the association between the status of EGFR, ALK, KRAS and overall survival (OS) measure: Evaluation of the association between the status of EGFR, ALK, KRAS and disease free survival (DFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology city: Milan country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06331962 id: B-ER-112-010 briefTitle: Digestive Tract Cancer and CIPN overallStatus: RECRUITING date: 2023-05-19 date: 2025-07-31 date: 2025-07-31 date: 2024-03-26 date: 2024-03-26 name: National Cheng-Kung University Hospital class: OTHER name: National Cheng Kung University briefSummary: According to the incidence rate of cancer, the digestive tract cancer accounts for two of the top ten cancers. It also accounts for half of the top ten causes of cancer death. Chemotherapy remains one of the most common forms of cancer treatment, and chemotherapy-induced peripheral neuropathy (CIPN) is one of the common adverse effects of cancer treatment in cancer survivors. To date, there is no exercise guideline established for patients with CIPN; therefore, CIPN remains quite threatening to cancer survivors. Due to limited studies on effects of exercise on improvement of CIPN symptoms in patients with digestive tract cancers, this study aims to investigate the effects of exercise and different intervention delivery modes (remote home exercise and exercise under supervision) at different time points on the CIPN symptoms, body inflammatory index, physical function, and quality of life of gastrointestinal cancer survivors with chemotherapy-induced peripheral neuropathy. conditions: Digestive Tract Cancer conditions: Chemotherapy-induced Peripheral Neuropathy conditions: Remote Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: remote home-based exercise therapy group name: supervised exercise therapy group name: regular care group measure: Basic information measure: gene measure: body height measure: body weight measure: body mass index measure: blood data measure: Questionnaire of Quality of Life measure: Questionnaire of Chemotherapy-Induced Peripheral Neuropathy measure: Muscle Strength measure: Dynamic Balance measure: Sensation Test measure: Cardiovascular Endurance sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Physical Therapy, National Cheng-Kung University status: RECRUITING city: Tainan zip: 701 country: Taiwan name: Cheng-Feng Lin, Ph.D role: CONTACT lat: 22.99083 lon: 120.21333 hasResults: False

 nctId: NCT06331949 id: TR TOKAT02 briefTitle: Video Supported Training on Non-Stress Test Application to Pregnant Women overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-11-01 date: 2024-11-01 date: 2024-03-26 date: 2024-03-26 name: Hilal Özbek class: OTHER briefSummary: Women go through many practices during their pregnancy. These practices, along with ignorance, create stress in the mother. However, performing the procedures for the first time may increase the mother's stress level. Stress during pregnancy also affects prenatal attachment. Non-Stress Test (NST) Application is a test applied to pregnant women starting from the 28th week of pregnancy and provides information about the baby's well-being and uterine contractions. There is a gap in the literature regarding education for pregnant women undergoing NST regarding stress levels and prenatal attachment. With this study, stress levels and prenatal attachment levels in pregnant women will be determined during NST, which is frequently applied during pregnancy. Additionally, the effects of midwifery care in this process will be realized. In this way, solutions will be produced for problems that may arise. A better quality of midwifery care will be provided conditions: First Pregnancy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 74 type: ESTIMATED name: video assisted training measure: State-Trait Anxiety Scale measure: Prenatal Attachment Inventory (PAI) measure: State-Trait Anxiety Scale measure: Prenatal Attachment Inventory (PAI) measure: State-Trait Anxiety Scale measure: Prenatal Attachment Inventory (PAI) sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT hasResults: False

 nctId: NCT06331936 id: Shenzhen Project briefTitle: Improving Emotional Regulation Skills of Children in Difficulty in Shenzhen overallStatus: RECRUITING date: 2024-01-06 date: 2024-06 date: 2024-09 date: 2024-03-26 date: 2024-03-26 name: City University of Hong Kong class: OTHER name: International Social Service Hong Kong Branch briefSummary: The study aims to 1) improve the emotional regulation strategies of children in difficulty in Shenzhen, and 2) develop and publish a set of evidence-based intervention manuals for professional use. Based on the intervention manual design of the researchers' previous study conducted in Hong Kong, the current research revised the intervention manual to adapt to the context of mainland China. This study adopts a randomized wait-list control trial design. The researchers aim to recruit 200 children in difficulty aged 8 to 14 as participants and randomly assign them to an experimental and a wait-list control group with a ratio of 3:2. Each participant will attend four sessions of intervention and one booster session, and each session requires around 1.5 to 2 hours to complete. The participants will complete assessments before the first session of the intervention (T1), immediately after the fourth session of the intervention (T2), and one month after the completion of the intervention (T3). A qualitative assessment will also be conducted after the booster session. conditions: Emotion Regulation conditions: Parent-Child Relations conditions: Happiness conditions: Positive Affect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Children will be randomly assigned to two groups: intervention and waitlist control groups. Children in the waitlist control group will receive experimental intervention after treatment for the experimental group finishes. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: At the recruitment phase, the participants and the social workers who lead the intervention will not know which arm the participants will be assigned. A cluster of approximately 10 participants formed a group based on their attendance date in the intervention program. This group will be randomly assigned to one of the two intervention arms through pre-prepared randomization list calculated by random allocation software. whoMasked: PARTICIPANT count: 200 type: ESTIMATED name: Emotion regulation measure: 10-item Emotional Management Strategy Questionnaire measure: 10-item Positive and Negative Affect Schedule measure: Patient Health Questionnaire-9 measure: Generalized Anxiety Disorder Scale measure: Subjective Happiness Scale measure: Connor-Davidson Resilience Scale 10-Item measure: Child-Parent Relationship Scale measure: Family Harmony Scale sex: ALL minimumAge: 8 Years maximumAge: 14 Years stdAges: CHILD facility: City University of Hong Kong status: RECRUITING city: Hong Kong country: China name: Nancy Xiaonan YU, Ph.D. role: CONTACT phone: (852)34429436 email: nancy.yu@cityu.edu.hk lat: 22.39407 lon: 114.13737 hasResults: False

 nctId: NCT06331923 id: U1111-1305-0484 briefTitle: Assessing the Effectiveness of Continuous Glucose Monitoring in Enhancing Surgical Outcomes for Diabetic Patients overallStatus: RECRUITING date: 2024-04-12 date: 2025-10-31 date: 2025-12-31 date: 2024-03-26 date: 2024-04-16 name: Beijing Tsinghua Chang Gung Hospital class: OTHER name: Peking University International Hospital name: Wang Jing Hospital name: ZhuHai Hospital name: Beijing Hospital name: Siyang County Hospital of Traditional Chinese Medicine name: Second Hospital of Shanxi Medical University name: Henan Provincial Chest Hospital name: Fuzhou First Hospital name: Pinggu Hospital of Beijing Traditional Chinese Medicine Hospital name: The First Affiliated Hospital of Anhui University of Chinese Medicine name: The First Affiliated Hospital of Zhengzhou University name: Mindong Hospital of Ningde name: The Fifth Hospital of Xiamen name: People's Hospital of Ningxia Hui Autonomous Region name: The First People's Hospital of Changzhou name: The Fifth hospital of Deyang name: Suzhou Municipal Hospital name: Tang-Du Hospital name: Yiyang Central Hospital name: First Affiliated Hospital of Xinjiang Medical University name: Peng Ding Shan Shi Zhong Yi Yi Yuan name: Yueyang Central Hospital name: The First People's Hospital of Lianyungang name: Haimen District Traditional Chinese Medicine Hospital name: The 910th Hospital name: The Second Affiliated Hospital of Zhejiang Chinese Medical University name: Beijing Tiantan Hospital name: Affiliated Hospital of Jiangsu University name: Liaocheng People's Hospital name: Beijing Chao Yang Hospital name: Jilin City Hospital of Chemical Industry name: Creen Hospital-465 name: Wuhan Central Hospital name: Air Force Military Medical University, China name: Shanghai Tong Ren Hospital name: Beijing Anzhen Hospital name: Emergency General Hospital name: Beijing Tongren Hospital name: Civil Aviation General Hospital name: Peking University Shougang Hospital name: The First Affiliated Hospital of Anhui Medical University name: Chinese PLA Central Hospital briefSummary: The goal of this multi-center, pragmatic, randomized controlled trial is to assess the effectiveness of continuous glucose monitoring (CGM) compared with conventional monitoring in enhancing surgical outcomes for diabetic patients. The main questions it aims to answer are:

* To assess the effectiveness of CGM compared with conventional monitoring in reducing the comprehensive complication index (CCI) for patients with diabetes or impaired glucose tolerance (IGT) within 30 days after surgery.
* To analyze the impact of different age groups, types of surgery, preoperative levels of HbA1c, and preoperative 24h glycemic variations on the improvement of surgical outcomes under the CGM model.

Participants will receive CGM prescribed by the attending physician for at least 6 hours before surgery. Glucose monitoring should be continued until the 7th day after surgery or discharge.

The investigators will compare conventional monitoring group to see if CGM could reduce the CCIs for patients with diabetes or impaired glucose tolerance within 30 days after surgery. conditions: Comprehensive Complication Index studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 10168 type: ESTIMATED name: Continuous glucose monitoring (CGM) device measure: Comprehensive complication index measure: Postoperative complications measure: Morality measure: The length of the stay in the intensive care unit measure: The length of hospital stay measure: The overall hospitalization cost measure: Perioperative glucose level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhifeng Gao status: RECRUITING city: Beijing state: Beijing zip: 102218 country: China name: Zhifeng Gao, MD role: CONTACT phone: 18756235568 email: btchgzf@hotmail.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06331910 id: TITNCUES briefTitle: Efficacy and Safety of Topical Insulin for Neurotrophic Corneal Ulcers overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-05-01 date: 2024-03-26 date: 2024-03-26 name: Assiut University class: OTHER briefSummary: To evaluate Safety and efficacy of topical insulin in treatment of neurotrophic corneal ulcers conditions: Neurotrophic Keratopathy studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 14 type: ESTIMATED name: insulin eye drops measure: Decrease in ulcer size and the increase in visual acuity . sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06331897 id: Bronchial asthma briefTitle: Bronchial Asthma & Its Exacerbation overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2026-01-01 date: 2026-06-01 date: 2024-03-26 date: 2024-03-26 name: Assiut University class: OTHER briefSummary: Our goals is to assess :

1¬_ the role of spirometer in case of asthma exacerbation 2_hematological parameters (N/L ratio \&amp; platelet indices \&amp;CRP )in asthma exacerbation for diagnosing and classifying asthma severity and its exacerbation conditions: Bronchial Asthma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Assessment of Broncial asthma & its exacerbation : the utility of laboratory investigation , chest imaging , pulmonary function tests sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06331884 id: PCZ_Phase1 briefTitle: Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics/-Dynamics of AK1967 (Procizumab) overallStatus: RECRUITING date: 2024-03-07 date: 2024-07-31 date: 2024-07-31 date: 2024-03-26 date: 2024-03-26 name: 4TEEN4 Pharmaceuticals GmbH class: INDUSTRY briefSummary: Dipeptidyl peptidase 3 (DPP3) is a protease involved in the degradation of several cardiovascular mediators. During cardiogenic shock, upregulation of the vasoconstrictive molecule angiotensin II is a physiologic and potentially life-saving response aimed at maintaining adequate tissue perfusion. As circulating (c)DPP3 is able to effectively cleave angiotensin II, it may represent a novel factor contributing to hemodynamic instability during cardiogenic shock.

Recently, a cDPP3-antagonizing antibody called AK1967 (commonly referred to as Procizumab) has been developed. In animal models of cardiogenic- and septic shock, inhibition of cDPP3 by AK1967 resulted in improved cardiac function and survival. Furthermore, AK1967 has shown an excellent safety record in different preclinical studies. In the current study the safety, tolerability and pharmacokinetics/-dynamics of AK1967 will be investigated in healthy male subjects. conditions: Safety and Tolerability studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: AK1967 (Procizumab) name: Placebo measure: Reported number of adverse events from baseline (start of Procizumab administration) up until the last follow-up visit after Procizumab administration sex: MALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Radboud University Medical Center status: RECRUITING city: Nijmegen state: Gelderland zip: 6525 country: Netherlands name: Peter Pickkers, MD, PhD role: CONTACT lat: 51.8425 lon: 5.85278 hasResults: False

 nctId: NCT06331871 id: 2004202111621 briefTitle: Effectiveness of US-PENS for Patients With Post-surgical Shoulder Pain overallStatus: RECRUITING date: 2024-02-01 date: 2025-10-30 date: 2025-10-30 date: 2024-03-26 date: 2024-03-26 name: Universidad Rey Juan Carlos class: OTHER briefSummary: The aim of this clinical trial was to demonstrate the effectiveness of the application of ultrasound-guided percutaneous nerve stimulation (US-PENS) directed at the axillary nerve and the suprascapular nerve, in patients with post-surgical shoulder pain.

This is a randomized, longitudinal, prospective and quasi-experimental clinical trial in which a total of 70 patients divided into two groups; physiotherapy protocol group (n=35) and experimental group to which the same protocol was practiced and a US-PENS session was added (n=35).

The intervention and follow-up period of the participants took place over 12 weeks. conditions: Ultrasound-Guided Percutaneous Electrical Nerve Stimulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 70 patients with shoulder pain undergoing arthroscopic surgery were recruited. They were divided into two groups at random; physiotherapy protocol group (n=35) and experimental group to which the same protocol was practiced and two sessions of ultrasound-guided percutaneous nerve stimulation (US-PENS) were added (n=35). primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: Ultrasound Guied Percutaneus Electrical Nerve Stimulation (US-PENS) and Manual physiotherapy protocol based on available evidence. name: Manual physiotherapy protocol based on available evidence. measure: The Numeric Pain Rating Scale (NPRS) measure: Disabilities of the Arm, Shoulder and Hand (DASH) measure: The Shoulder Pain and Disability Index (SPADI) measure: GONIOMETRY measure: DINAMOMETRY measure: PAIN THRESHOLD ON PRESSURE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinica Cemtro status: RECRUITING city: Madrid zip: 28049 country: Spain name: MARIO J ABRIL SERVÁN role: CONTACT phone: +34636707810 email: MASERVAN@HOTMAIL.COM name: FERNANDO GARCÍA SANZ role: CONTACT phone: +34917355757 email: fisioterapiaclub@clinicacemtro.com name: MARIO J ABRIL SERVÁN role: PRINCIPAL_INVESTIGATOR name: ADRIÁN CASES role: SUB_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06331858 id: KutahyaHSU-DRGOKPINARDROMER-43 briefTitle: The Effect of Adding Instrumented Hip Concentric Abductor Strengthening Exercise in Knee Osteoarthritis overallStatus: RECRUITING date: 2023-09-20 date: 2024-03-29 date: 2024-03-29 date: 2024-03-26 date: 2024-03-26 name: Kutahya Health Sciences University class: OTHER briefSummary: The aim of this study was to investigate the effectiveness of adding hip device-assisted concentric abductor strengthening (HDACAS) program to knee device-assisted concentric flexor-extensor strengthening (KDACFES) program on pain, function, physical performance, quality of life and gait parameters in patients with knee osteoarthritis (OA). conditions: Knee Osteoarthritis conditions: Pain conditions: Physical Disability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1. STUDY GROUP
2. CONTROL GROUP primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Before and after the treatment, all patients were evaluated by a blind evaluator in terms of physical examination, pain and functionality, physical performance, quality of life and gait parameters. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: hip device-assisted concentric abductor strengthening (HDACAS) name: knee device-assisted concentric flexor-extensor strengthening (KDACFES) measure: Western Ontario and McMaster Universities (WOMAC) measure: The Lequesne Algofunctional index measure: TIME UP AND GO TEST measure: 30 SECOND CHAIR TEST measure: 40 METER SELF PACED WALK TEST measure: SIX MINUTES WALK TEST measure: STAIR CLIMB TEST measure: Visual Analog Scale (VAS) measure: Mini Osteoarthritis Knee and Hip Quality of Life Scale sex: ALL minimumAge: 45 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kutahya Health Sciences University status: RECRUITING city: Kutahya zip: 43100 country: Turkey name: Hasan Huseyin Gokpinar, Ass. Prof. role: CONTACT phone: +905052842222 email: hasanhuseyin.gokpinar@ksbu.edu.tr name: Ömer Özyümlü role: CONTACT phone: +905442024671 email: omer.ozyumlu@gmail.com lat: 39.42417 lon: 29.98333 facility: Kutahya Health Sciences University status: RECRUITING city: Kutahya zip: 43100 country: Turkey name: Hasan Huseyin Gokpinar, Ass. Prof. role: CONTACT phone: +905052842222 email: hasanhuseyin.gokpinar@ksbu.edu.tr lat: 39.42417 lon: 29.98333 hasResults: False

 nctId: NCT06331845 id: NPC012 briefTitle: Stop and go Strategy as First-line Treatment for Widely Metastatic Nasopharyngeal Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2028-05-01 date: 2024-03-26 date: 2024-03-26 name: Fujian Cancer Hospital class: OTHER_GOV briefSummary: This study aimed to investigate the value of a novel strategy of intermittent systematic chemotherapy (ISC) in widely metastatic nasopharyngeal carcinoma (wmNPC) patients who achieve objective response after systematic chemotherapy (SC). conditions: Metastatic Nasopharyngeal Carcinoma conditions: Intermittent Systematic Chemotherapy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 39 type: ESTIMATED name: Gemcitabine name: Cisplatin name: Paclitaxel protein-bound name: Capecitabine name: Tislelizumab measure: progression-free survival measure: progression-free survival 2 measure: overall survival sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06331832 id: 2323-EAP id: 2021-002339-44 type: EUDRACT_NUMBER briefTitle: Expanded Access of Imvotamab (IGM-2323) in Patients With R/R NHL overallStatus: NO_LONGER_AVAILABLE date: 2024-03-26 date: 2024-03-26 name: IGM Biosciences, Inc. class: INDUSTRY briefSummary: Expanded Access of Imvotamab (IGM-2323) in Patients with Relapsed/Refractory Non-Hodgkin Lymphomas from IGM-2323-001 clinical trial. conditions: Relapsed/Refractory Non-Hodgkin Lymphomas studyType: EXPANDED_ACCESS name: IGM2323 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sir Charles Gairdner Hospital city: Nedlands state: Western Australia country: Australia lat: -31.98184 lon: 115.8073 facility: Samsung Medical Center city: Seoul state: Gangnam-gu country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: START-Madrid Centro Integral Oncologico Clara Campal city: Madrid country: Spain lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06331819 id: 7-3-2024 briefTitle: Clinical Association Between Obstructive Sleep Apnea, Facial Pigmentation, and Vasovagal Symptoms. acronym: VasOSA overallStatus: RECRUITING date: 2024-03-10 date: 2025-01-01 date: 2025-03-01 date: 2024-03-26 date: 2024-03-26 name: Jordan Collaborating Cardiology Group class: OTHER briefSummary: The goal of this prospective cohort study is to study patients referred for sleep study by in-lab polysomnography in the Jordan University Hospital and the Jordan Hospital. The main aims are:

* To prospectively obtain demographic and clinical information of patients referred for a sleep study.
* To determine the diagnostic value of facial discoloration as potential marker for obstructive sleep apnea to increase detection rate for the condition.
* To establish a correlation between obstructive sleep apnea and vasovagal symptoms with resulting increased smoking tendency and study the effect of treatment on the disorders.
* To determine the association between timing of appearance of obstructive sleep apnea symptoms and initiation of smoking. conditions: Obstructive Sleep Apnea conditions: Vasovagal Syncope conditions: Smoking conditions: Acanthosis Nigricans studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: In-lab polysomnography name: Continuous positive airway pressure measure: Clinical association between obstructive sleep apnea and presence of facial pigmentation measure: Clinical association between obstructive sleep apnea and severity of facial pigmentation measure: Relation between obstructive sleep apnea and vasovagal symptoms measure: Relation between obstructive sleep apnea and resulting smoking tendency due to vasovagal symptoms measure: Relation between obstructive sleep apnea and the effect of treatment on facial discolouration measure: Relation between obstructive sleep apnea and the effect of treatment on vasovagal symptoms measure: Relation between obstructive sleep apnea and the effect of treatment on smoking habits sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Jordan status: RECRUITING city: Amman zip: 11942 country: Jordan name: Asma Btoosh, MD role: CONTACT phone: 00962797684137 email: asmaalbtoosh@gmail.com name: Rand M Zaqqa role: PRINCIPAL_INVESTIGATOR name: Ayah M Zaqqa, MD role: PRINCIPAL_INVESTIGATOR name: Maisa Mansoor, MD role: PRINCIPAL_INVESTIGATOR name: Asma Btoosh, MD role: PRINCIPAL_INVESTIGATOR name: Salah Salah role: SUB_INVESTIGATOR lat: 31.95522 lon: 35.94503 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-07 uploadDate: 2024-03-07T14:03 filename: Prot_000.pdf size: 82683 hasResults: False

 nctId: NCT06331806 id: IEO 398 briefTitle: Myocardial Fibrosis Identification in Patients With Anthracycline-induced Cardiotoxicity overallStatus: RECRUITING date: 2018-02-22 date: 2024-12-31 date: 2024-12-31 date: 2024-03-26 date: 2024-03-26 name: European Institute of Oncology class: OTHER briefSummary: This is an interventional study for patients who had developed Anthracycline-Induced Cardiotoxicity (AIC) during or after anthracycline-containing therapy, referred to the Cardioncology Unit for heart failure treatment conditions: Cardiomyopathy Due to Drug studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: Evaluation of myocardial fibrosis measure: Evaluation of blood levels of Suppression Of Tumorigenicity 2 (ST2) measure: Evaluation of blood levels of Galectin-3 (Gal-3) measure: Evaluation of Enhanced Liver Fibrosis score (ELF) measure: Evaluation of CMR imaging marker of fibrosis measure: Evaluation of response to heart failure treatment measure: Evaluation of levels of Troponin I (TnI) and B-type Natriuretic Peptide (BNP) measure: Evaluation of levels of cytochrome C sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Daniela Cardinale, MD role: CONTACT email: daniela.cardinale@ieo.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06331793 id: IEO 1849 briefTitle: Pulsed Electromagnetic Fields for Analgesia Post Mastectomy acronym: Algocare overallStatus: RECRUITING date: 2023-05-09 date: 2024-12-31 date: 2024-12-31 date: 2024-03-26 date: 2024-03-26 name: European Institute of Oncology class: OTHER briefSummary: Study aim is to test AlgoCare, a device that uses the technology PEMF (Pulsed ElectroMagnetic Fields) for the treatment of postoperative pain in oncological breast surgery, in order to demonstrate that the use of Algocare in the postoperative period allows for a reduction in pain intensity in terms of Numerical Rating Scale (NRS) score and use of analgesic drugs. conditions: Female Breast Cancer conditions: Post Operative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomization 1:1 primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double blind whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 160 type: ESTIMATED name: Active AlgoCare name: Non-active AlgoCare measure: Pain intensity measure: Need for analgesic drugs measure: Patient reported pain characteristics measure: Number of participants with other symptoms measure: Need for other drugs measure: Wound healing timing sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan zip: 20141 country: Italy name: Daniele Sances, MD role: CONTACT phone: +390257489618 email: daniele.sances@ieo.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06331780 id: WS10370 id: 2023-A02153-42 type: OTHER domain: ANSM (France) briefTitle: Refractive Status and Accommodation Response Under Different Experimental Conditions. overallStatus: RECRUITING date: 2024-02-22 date: 2024-07-31 date: 2024-12-31 date: 2024-03-26 date: 2024-03-26 name: Essilor International class: INDUSTRY briefSummary: Eye Care Professionals (ECPs) massively use auto-refractors during the patient journey to measure the objective refractive error: starting point of the subjective eye refraction. These devices provide objective information about the refractive and accommodative state of the eye, useful for the ECP to perform a complete eyesight test. Auto-refractor data for the distance vision are repeatable and accurate but near vision information are not enough reliable to build an accurate near vision routine exam. Previous internal studies, with auto refractors currently on the market, have shown that, during accommodation measurements, a large proportion of participants had a lower accommodative response than expected. conditions: Accommodation Disorder conditions: Accommodative Fatigue conditions: Accommodative Inertia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 55 type: ESTIMATED name: Visual acuity name: Objective refraction name: Objective monocular accommodation amplitude measurement name: Subjective monocular accommodation amplitude measurement with the "Push-Up" method name: Subjective monocular accommodation facility measurement with the "Rock" method: name: CISS Questionnaire name: Difficulty assessment questionnaire name: Subjective evaluation questionnaire measure: Accommodative response measured with closed-field aberrometer with different target displacement methods measure: Accommodative response measured with closed-field aberrometer with different displayed targets measure: Objective refraction measured with closed-field aberrometer and two camera exposure times sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Essilor International - Ci&T 2 status: RECRUITING city: Créteil zip: 94000 country: France name: Jérôme Gillet role: CONTACT phone: +33 (0)1 49 80 63 40 email: gilletj@essilor.fr lat: 48.78333 lon: 2.46667 hasResults: False

 nctId: NCT06331767 id: 2024P000654 briefTitle: Development of a Multilevel HIV Prevention Intervention for the Emergency Department acronym: mSYNC overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2029-04 date: 2029-04 date: 2024-03-26 date: 2024-03-26 name: Brigham and Women's Hospital class: OTHER briefSummary: The goal of this clinical trial is to pilot test a psychosocial-behavioral mobile health (mHealth) human immunodeficiency virus (HIV) prevention intervention in people who use drugs presenting to the emergency department (ED). The main question the study aims to answer is: is the intervention acceptable and appropriate? Participants will use the mHealth app while waiting in the ED and also at home for 90 days. Participants will be asked to complete surveys at baseline, before leaving the ED, and at 30-, 60-, and 90-day follow up visits. conditions: HIV conditions: Drug Use conditions: Mental Health conditions: Psychological Distress conditions: Social Marginalization conditions: Problems With Access to Health Care studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: mSYNC measure: Acceptability measure: Acceptability measure: Acceptability measure: Appropriateness measure: Appropriateness measure: Appropriateness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06331754 id: ATMANHEALTH001 briefTitle: Technology-Enabled Remote Hypertension Management To Advance Health Equity overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2025-09-17 date: 2026-03-17 date: 2024-03-26 date: 2024-03-26 name: Atman Health, Inc class: INDUSTRY briefSummary: The primary objective of this study is to reliably estimate the difference in blood pressure control of a technology-enabled solution for blood pressure (BP) management over usual care. The study will also assess patient and provider satisfaction with the solution. Finally, the investigators will estimate the economic impact of the intervention in terms of resource utilization. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: non-blinded pragmatic cluster-randomized controlled trial with a single intervention primaryPurpose: TREATMENT masking: NONE count: 1500 type: ESTIMATED name: Technology-enabled blood pressure management measure: Difference in SBP change measure: HEDIS proportion measure: Difference in DBP change measure: Home measured change in SBP and DBP measure: Patient satisfaction measure: Provider satisfaction measure: Mean time required per patient for provider measure: Mean time required per patient for navigator measure: Proportion of patients measuring blood pressure at directed frequency measure: Resource utilization sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06331741 id: 0403 briefTitle: Collagen for Treatment of Musculoskeletal Injuries overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2026-03-01 date: 2024-03-26 date: 2024-03-26 name: I.M. Sechenov First Moscow State Medical University class: OTHER briefSummary: The purpose of the study:

Evaluation of the clinical efficacy and safety of the use of collagen matrix/membrane in the surgical treatment of the consequences of injuries and diseases of the musculoskeletal system (anterior cruciate ligament tears, rigid first toe) by using IKDC, KOOS, ACLOAS, VAS, AOFAS, SF-36 scales conditions: Anterior Cruciate Ligament Injuries conditions: Hallux Rigidus studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Main group for ACL: 5 patients with ACL injury, who undergo ACL reconstruction with collagen membrane augmentation; Reference group for ACL: 5 patients with ACL injury, who undergo ACL reconstruction without collagen membrane augmentation; Main group for HR (Hallux Rigidus): 5 patients with Hallux Rigidus, who undergo resection arthroplasty with introduction of collagen membrane Reference group: none primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 15 type: ESTIMATED name: Anterior cruciate ligament reconstruction, using graft, augmented with collagen membrane name: Anterior cruciate ligament reconstruction, using graft, not augmented with collagen membrane (control group) name: Resection arthroplasty of the first metatarsophalangeal joint with the introduction of a collagen membrane into the joint cavity measure: The International Knee Documentation Committee score measure: The Knee injury and Osteoarthritis Outcome Score measure: Modified Lysholm scale measure: Anterior Cruciate Ligament OsteoArthritis Score measure: American Orthopaedic Foot and Ankle Society, Ankle-Hindfoot Score measure: 36-Item Short Form Survey sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: university clinical hospital № 1I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster Surgery status: RECRUITING city: Moscow zip: 119991 country: Russian Federation name: Marina M Lipina, MD, PhD role: CONTACT phone: +79253122096 email: marina.lipina@icloud.com lat: 55.75222 lon: 37.61556 hasResults: False

 nctId: NCT06331728 id: IGNX-T1 briefTitle: Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IGNX001 overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-08 date: 2025-10 date: 2024-03-26 date: 2024-03-26 name: IgGenix Australia Pty Ltd class: INDUSTRY briefSummary: The goal of this randomized, double-blind, placebo-controlled, single ascending dose clinical trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IGNX001 in peanut-allergic adults and older Adolescents. conditions: Peanut Allergy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, double-blind, placebo-controlled, single ascending dose study with single blind sentinel period primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: With the exception of the single sentinel participants for each cohort who will be single blinded (participant blinded), the study will be designed as a double-blind study thus the Investigator, site staff (other than pharmacists), sponsor, sponsors delegates (if applicable) and participants are all blinded to treatment. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: IGNX001 name: Placebo measure: Incidence and Severity of Treatment Emergent Adverse Events measure: Incidence of Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions measure: Number of Participants with Clinically significant Changes from Baseline - Hematology measure: Number of Participants with Clinically Significant Changes from Baseline - Chemistry measure: Number of Participants with Clinically Significant Changes from Baseline - 12-lead ECGs for HR, PR, QRS, QT, RR and QTcF, and information on T- and U-waves measure: Number of Participants with Clinically Significant Changes from Baseline - Physical Examinations measure: Concentration of IGNX001 in the Plasma measure: Measurement of Area under the Plasma/Serum Concentration Curve (AUC) measure: Peak Serum Concentration (Cmax) measure: Time to Peak Serum Concentration (Tmax) measure: Elimination Half-life (t1/2) measure: Changes Over Time to Anti-drug Antibodies sex: ALL minimumAge: 15 Years maximumAge: 55 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06331715 id: ML1005 briefTitle: Bioequivalence Study of Palbociclib 125 mg Capsules of Iclos vs. Ibrance (Palbociclib) Capsules 125 mg overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2024-08-01 date: 2024-08-31 date: 2024-03-26 date: 2024-03-26 name: Megalabs class: INDUSTRY briefSummary: An open label, balanced, randomized, two treatments, two sequences, two periods, cross over, single dose, bioequivalence study of Palbociclib 125 mg Capsules of Iclos Uruguay S.A and IBRANCE® (Palbociclib) 125 mg Capsules of Pfizer Europe (Belgium) in healthy, adult, human subjects under fed condition. conditions: Bioequivalence studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 24 type: ESTIMATED name: Palbociclib 125mg measure: AUC 0-t measure: Cmax sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06331702 id: CDBJEIV2023001 briefTitle: Immunogenicity of Japanese Encephalitis Vaccine Co-administered With Measles-Mumps-Rubella Vaccine (MMR) overallStatus: RECRUITING date: 2024-03-02 date: 2024-09-30 date: 2024-12-31 date: 2024-03-26 date: 2024-03-26 name: Liaoning Chengda Biotechnology CO., LTD class: INDUSTRY briefSummary: This is a phase IV, randomized, controlled, open-label study proceed in healthy children aged 8 months in China. The primary objective is to demonstrate the immunogenicity of simultaneous administration of JEV-I and MMR is not inferior to that of separate administration, as measured by seroconversion rates and antibody titers against the four antigens. The secondary objective is to describe the safety of the vaccines when administered simultaneously or separately. conditions: Japanese Encephalitis conditions: Measles conditions: Mumps conditions: Rubella studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 396 type: ESTIMATED name: Vero cell-drived inactive Japanese encephalitis vaccine name: Measles-Mumps-Rubella Vaccine measure: Antibody Titer for Post Vaccination measure: Seroconversion Rate for Post Vaccination measure: Incidence of Any Local and Systemic Adverse Events Within 30 Minutes of Each Vaccination measure: Incidence of Solicited Local and Systemic Adverse Events Within 7 Days of Each Vaccination measure: Incidence of Unsolicited Adverse Events and Serious Adverse Events Within 30 Days of Post Vaccination sex: ALL minimumAge: 8 Months maximumAge: 12 Months stdAges: CHILD facility: Jiangsu Provincial Center for Disease Control and Prevention status: RECRUITING city: Nanjing state: Jiangsu zip: 210009 country: China name: Zhiguo Wang, Master role: CONTACT phone: +86 18118996978 email: 120714991@QQ.com name: Zhiguo Wang, Master role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06331689 id: HP-epidemıology briefTitle: EPIDEMIOLOGY AND ITS RESULTS IN HIP FRACTURES FOLLOWED IN POSTOPERATIVE INTENSIVE CARE acronym: Hip fractures overallStatus: COMPLETED date: 2021-02-01 date: 2021-04-01 date: 2021-07-01 date: 2024-03-26 date: 2024-03-26 name: Kutahya Health Sciences University class: OTHER briefSummary: Type of study: Observational study Goal of this : We conducted a retrospective evaluation of patients with HF who received postoperative ICU, with a focus on 30-day, 90-day and 1-year mortality outcomes.

Participant population/health conditions:Patients over the age of 18 who are hospitalized in the intensive care unit of our hospital after hip fracture operation. conditions: Hip Fracture conditions: Mortality Rate studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 68 type: ACTUAL measure: mortalite ratio sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kütahya Health Sciences University city: Kütahya zip: 43100 country: Turkey lat: 39.42417 lon: 29.98333 hasResults: False

 nctId: NCT06331676 id: 69HCL23_1120 id: 2023-A02339-36 type: OTHER domain: ID RCB briefTitle: Developing a Complex ex Vivo Endometrial Tissue Model to Improve Endometriosis Care acronym: OTEndo overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-10 date: 2025-10 date: 2024-03-26 date: 2024-03-26 name: Hospices Civils de Lyon class: OTHER briefSummary: Endometriosis is a chronic gynaecological disease characterised by the growth of endometrium outside the uterus. It affects 10% of childbearing age women.

There is no cure for endometriosis. Hormonal treatments should be the first line therapy. The benefit-risk ratio of symptomatic treatment with hormone therapy varies greatly from one woman to another. The pathophysiology of endometriosis and the mechanisms of action of these treatments are still poorly understood. This may be due to the lack of an optimal experimental model for studying the disease.

The aim of this project is to develop a complex ex vivo endometrial model recapitulating the organisation and properties of the human endometrium using innovative tissue bioengineering methods. This model will make it possible to develop a pre-clinical approach that predicts individual response to different types of hormonal treatment in order to optimise therapeutic choices and provide a better understanding of the effects of these treatments. conditions: Endometriosis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants enrolled in this study will be given an eutopic and ectopic endometrium biopsies, blood and peritoneal fluid sampling and should answer to a questionnaire on menstrual health and history of hormone treatments for the research purpose.. primaryPurpose: BASIC_SCIENCE masking: NONE count: 45 type: ESTIMATED name: Tissue collection name: Data collection measure: Viability of all the cells forming the complex endometrial tissue generated ex vivo by tissue bioengineering. measure: Change in protein expression measure: Change in gene expression measure: Change in inflammation measure: Change in histological tissue structure measure: Change in histological tissue structure measure: Change in tissue elasticity measure: Change in steroid hormone physiology measure: Steroid hormones in peritoneal fluid sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Hôpital Femme Mère Enfant / GHE city: Bron zip: 69500 country: France name: Charles-André PHILIP, MD, PhD role: CONTACT phone: 04 27 85 51 70 phoneExt: +33 email: charles-andre.philip01@chu-lyon.fr lat: 45.73333 lon: 4.91667 facility: Hôpital de la Croix-Rousse / GHN city: Lyon zip: 69004 country: France name: Gil DUBERNARD, MD, PhD role: CONTACT phone: 04 72 07 16 42 phoneExt: +33 email: gil.dubernard@chu-lyon.fr lat: 45.74848 lon: 4.84669 hasResults: False

 nctId: NCT06331663 id: KMUHIRB-F(II)-20240055 briefTitle: SPI and Remifentanil in Skull Pin Fixation overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-20 date: 2024-06-20 date: 2024-03-26 date: 2024-03-26 name: Kaohsiung Medical University Chung-Ho Memorial Hospital class: OTHER briefSummary: Forty patients were enrolled, and all patients used total intravenous anesthesia (remifentanil-propofol based total intravenous analgesia) as anesthesia induction and maintenance. According to the preliminary data of this department, patients who underwent intracranial surgery for skull pin fixation used remifentanil 5.0-6.0 ng/ml, while the hemodynamics is relatively stable. Therefore, when this plan is implemented, the patient needs to be under the same depth of anesthesia (monitored by electroencephalography, maintaining a value of 40-60), first start with remifentanil 5.0 ng/ml, and use the up and down method as adjust 0.5 ng/ml of concentration of remifentanil each time. Inadequate antinociception (Surgical Pleth Index(SPI) \> 80 and hyperdynamics (the increased heart rate (HR) and mean blood pressure (MBP) above 20% of baseline or HR\>100bpm and arterial blood pressure(ABP)\>180/100mmHg)) is defined as failure, therefore we increase remifentanil by 0.5 ng/ml; otherwise, the setting is considered successful without abovementioned situations.

Data collection: heart rate, mean blood pressure, Surgical Pleth Index, bispectral Index, pulse pressure variance, systolic pressure variance, concentrations of propofol and remifentanil before 2 mins, during, 5, and 15 mins of skull pin fixation were recorded and analyzed. conditions: Pain, Procedural studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 27 type: ESTIMATED name: Remifentanil measure: 50% effect concentration of remifentanil measure: 90% effect concentration of remifentanil sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kaohsiung Medical University Chung-Ho Memorial Hospital city: Kaohsiung country: Taiwan name: Zhi-Fu Wu, MD role: CONTACT phone: 07-3121101 phoneExt: 7035 email: aneswu@gmail.com lat: 22.61626 lon: 120.31333 hasResults: False

 nctId: NCT06331650 id: CROC202314 briefTitle: A Single-arm Pilot Study of First-line Treatment With Carbognilumab Combined With Chemotherapy in Patients With STK11-mutated Advanced or Postoperative Recurrent Non-small Cell Lung Cancer overallStatus: RECRUITING date: 2023-08-09 date: 2025-08 date: 2025-10 date: 2024-03-26 date: 2024-03-26 name: Guangzhou Institute of Respiratory Disease class: OTHER briefSummary: To evaluate the safety and tolerability of carbognilumab combined with chemotherapy as the first-line treatment for patients with STK11 mutated advanced or postoperative recurrent non-small cell lung cancer (NSCLC). conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: cadonilimab measure: Safety assessments and ORR sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Guangzhou Medical University status: RECRUITING city: Guangdong state: Guangzhou zip: 510000 country: China name: zhou chegnzhi, doctor role: CONTACT phone: 13560351186 email: doctorzcz@163.com hasResults: False

 nctId: NCT06331637 id: 3782 briefTitle: Outcomes of Transanal Tran-section and Single-stapled (TTSS) Ileal Pouch-Anal Anastomosis acronym: TTSS-Pouch overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2026-07-31 date: 2026-12-31 date: 2024-03-26 date: 2024-03-26 name: Istituto Clinico Humanitas class: OTHER briefSummary: This study aims to compare the functional and surgical outcomes of Ulcerative Colitis (UC) patients undergoing Transanal Transection and Singl-Stapled (TTSS) versus Double-stapled Ileal Pouch-Anal Anastomosis (IPAA) conditions: Ulcerative Colitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 174 type: ESTIMATED name: Transanal Transection and Single-Stapled anastomosis (TTSS) name: Double-stapled anastomosis measure: Pouch Function Score (PFS) measure: Pouch Function Score (PFS) measure: Pouch Function Score (PFS) measure: Postoperative complications measure: Anastomotic leak measure: Patients fit for stoma closure measure: Healthcare costs measure: Rectal cuff lenght measure: Pouch complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Humanitas Research Hospital city: Rozzano state: MI zip: 20089 country: Italy name: Annalisa Maroli, PhD role: CONTACT phone: 02 8224 7776 phoneExt: 0039 email: colorapp@humanitas.it name: Stefano De Zanet, MS role: CONTACT phone: 02 8224 4623 phoneExt: 0039 email: colorapp@humanitas.it lat: 45.38193 lon: 9.1559 hasResults: False

 nctId: NCT06331624 id: GRI-0621-IPF-02 briefTitle: Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF overallStatus: RECRUITING date: 2024-03 date: 2025-01 date: 2025-01 date: 2024-03-26 date: 2024-03-26 name: GRI Bio Operations, Inc. class: INDUSTRY briefSummary: This is a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study. Approximately 36 subjects with IPF will be randomized in a 2:1 ratio for GRI-0621 4.5mg or Placebo. GRI-0621 dose of 4.5mg will be compared with placebo following once daily oral administration for 12 weeks. Concurrently, a Sub-Study will be conducted, examining the number and activity of NKT cells in BAL, for up to 12 eligible subjects (across various centers). An interim analysis will be performed when 24 subjects complete 6 weeks of treatment (approximately 8 placebo subjects). conditions: Idiopathic Pulmonary Fibrosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 36 type: ESTIMATED name: Tazarotene (GRI-0621) name: Placebo measure: Safety and Tolerability of oral GRI-0621 measure: Change from baseline biomarkers measure: Plasma concentrations of GRI-0621 measure: Pharmacodynamics of GRI-0621 in blood (Study Population) measure: Pharmacodynamics of GRI-0621 in BAL fluid (Optional Sub-Study) measure: Exploratory - Pulmonary Function sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Newport Native MD, Inc. status: RECRUITING city: Newport Beach state: California zip: 92663 country: United States name: Brandon Vu role: CONTACT phone: 949-791-8599 email: Brandon@newportnativemd.com lat: 33.61891 lon: -117.92895 facility: Southeastern Research Center status: RECRUITING city: Winston-Salem state: North Carolina zip: 27103 country: United States name: Karen McCutcheon role: CONTACT phone: 336-659-8414 email: kmccutcheon@southeasternresearchcenter.com lat: 36.09986 lon: -80.24422 hasResults: False

 nctId: NCT06331611 id: Motor briefTitle: MONITORING NEUROMUSCULAR BLOCK IN PAEDIATRIC ANAESTHESIA acronym: MOTOR overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-26 date: 2024-03-27 name: Istituto Giannina Gaslini class: OTHER briefSummary: To date there is still little scientific evidence regarding neuromuscular block monitoring in pediatric anesthesia and indications for safe reversal. Although the use of rocuronium and sugammadex is becoming wide, qualitative monitoring or clinical practice are applied instead of quantitative monitoring (acceleromyography-electromyography EMG). The use of neuromuscular monitoring leads to better control of intraoperative paralysis, proper timing of extubation, and reduced risk of residual postoperative paralysis-paralysis (PORC) and related complications.

The main objective of the study is to analyse the incidence of sugammadex use and the total dose/kg, with and without the aid of quantitative neuromuscular monitoring.

Secondary objectives are:

* the time required to extubate different patients,
* the incidence of respiratory complications at extubation,
* the need to administer additional doses of sugammadex. A prospective RCT. Patients will be divided into two study groups; in the first group, quantitative neuromuscular monitoring based on electromyography (EMG) will be used, while in the second group, the same monitoring will be applied but covered (blinded to the anesthetist) and the pharmacological strategy is based exclusively on the clinical practice All children aged between 2 months and 6 years, scheduled to undergo elective non-cardiac surgical procedures, lasting approximately from one to two hours(anesthesia time), with general anesthesia and tracheal intubation receiving a non-depolarizing blockade agent.
* Children between 2 months and 6 years
* Children who will undergo elective non cardiac surgery (maximum two hours of anesthesia time with tracheal intubation receiving a non depolarizing blockade agent),
* Acquisition of informed consent by a legally recognized representative capable of understanding the document and providing consent on behalf of the participant.

  * Children under 2 months of age or over 12 years of age,
  * Children with an ASA classification \&gt; 3,
  * Presence of neuromuscular disease, channelopathy, or any clinical condition that contraindicates the administration of neuromuscular muscle relaxants,
  * Confirmed or suspected allergy to sugammadex or rocuroniumt,
  * Presence of amputation or limb malformations that make placement of neuromuscular monitoring impossible,
  * Any specific contraindication to any aspect of the protocol. 12 months The randomization process will performed using numbers randomized by a computer-generated random number sequence. The randomization list will be prepared by independent statistician . The subjects will be assigned to the treatment arm in a sequence as per the randomization code provided in a closed envelope in a 1:1 ratio. The investigator will administered the treatment as per the randomization codes.

One hundred children undergo in the clinically guided group and 100 children in the neuromuscular monitoring groups with the aim to include 200 children in total.

Demographics and baseline characteristics with mean, median, standard deviation, and range (minimum, maximum) will generated for each arm. Subject disposition, including the number of subjects withdrawn or discontinued from the study, for each arm will summarized. The study will follow the CONSORT guidelines for statistical analysis and reporting. Chi squared test or Fisher's exact test and Student's t-test or Mann Whitney test will applied to categorical and continuous data, respectively, with a significance level of 5% by two-sided test. Statistical analysis was performed using SPSS software (ver. 21.0) (IBM, Armonk, NY, USA). conditions: Anesthesia,General conditions: Neuromuscular Blockade conditions: Tracheal Intubation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 200 type: ESTIMATED name: TOF monitoring measure: Sugammadex administration sex: ALL minimumAge: 2 Years maximumAge: 12 Years stdAges: CHILD hasResults: False

 nctId: NCT06331598 id: ML43332 id: 2022-003708-33 type: EUDRACT_NUMBER briefTitle: A Study of Adjuvant Atezolizumab or Atezolizumab Plus Tiragolumab in Solid Tumors With Resectable Disease With Intermediate-High Risk of Recurrence and High Tumor Mutational Burden (TMB-H) or Microsatellite Instability (MSI-H) acronym: IMperator overallStatus: RECRUITING date: 2024-05-30 date: 2028-10-20 date: 2029-09-20 date: 2024-03-26 date: 2024-04-17 name: Hoffmann-La Roche class: INDUSTRY briefSummary: This study is being conducted to evaluate efficacy parameters (disease free survival \[DFS\] and overall survival \[OS\]) of atezolizumab and atezolizumab in combination with tiragolumab in TMB-H or MSI-H as adjuvant treatment after standard radical intended treatment in participants with intermediate-high risk of recurrence. conditions: Solid Tumors studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Atezolizumab name: Tiragolumab measure: Disease Free Survival (DFS) Rate at 24 Months measure: DFS Rate at 36, 48 and 60 Months measure: OS (Overall Survival) measure: Percentage of Participants With Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitari Vall dHebron; Oncology status: RECRUITING city: Barcelona zip: 08035 country: Spain lat: 41.38879 lon: 2.15899 facility: Hospital Universitario Virgen; Servicio de Oncologia status: RECRUITING city: Sevilla zip: 41013 country: Spain lat: 37.38283 lon: -5.97317 hasResults: False

 nctId: NCT06331585 id: KY-2024004 briefTitle: Effect of Low-dose Radiotherapy on Tumor Immune Microenvironment in Oligometastases of NSCLC After Immunotherapy overallStatus: WITHDRAWN date: 2024-03-18 date: 2025-03-18 date: 2026-03-18 date: 2024-03-26 date: 2024-04-25 name: Hetian District People's Hospital class: OTHER briefSummary: The purpose of this phase Ⅱ trial was to investigate the effect of low-dose radiotherapy (LDRT) on the tumor immune microenvironment (TME) in oligometastasis, oligoprogression, and oligopersistence of non-small cell lung cancer (NSCLC) after immunotherapy. At least 20 participants will be enrolled in this study. All will take part at Hetian District People's Hospital. conditions: Low-dose Radiotherapy conditions: Tumor Microenvironment conditions: Non-Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 0 type: ACTUAL name: low dose radiotherapy measure: Analysis of the tumor immune microenvironment measure: Number of participants with Adverse Events and/or Dose Limiting Toxicities as a Measurement of Safety and Tolerability of Low Dose Radiotherapy measure: Progression Free Survival (PFS) measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hetian District People's Hospital city: Hetian state: Xinjiang Uygur Autonomous Region zip: 848000 country: China hasResults: False

 nctId: NCT06331572 id: 1stChongqingMU-TRD briefTitle: Exploring Blood Plasma Metabolomics: Unraveling the Metabolic Landscape in Treatment-Resistant Adolescent Depression overallStatus: COMPLETED date: 2021-08-01 date: 2021-10-25 date: 2023-12-20 date: 2024-03-26 date: 2024-03-26 name: First Affiliated Hospital of Chongqing Medical University class: OTHER briefSummary: This study contributes new evidence for the identification of adolescent TRD and sheds light on differing pathophysiologies by delineating distinct plasma metabolic profiles between adolescent TRD and FEDN-MDD. conditions: Psychiatric Disorder conditions: Major Depressive Disorder conditions: Metabolic Disorder studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 162 type: ACTUAL name: 17-HAMD measure: 17 items Hamilton Depression Scale measure: Hamilton Anxiety Scale sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: The First Affiliated Hospital of Chongqing Medical University city: Chongqing state: Province zip: 400000 country: China lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06331559 id: SIM0501-101 briefTitle: Study of SIM0501 Alone and in Combination in Patients With Advanced Solid Tumors overallStatus: RECRUITING date: 2024-03-19 date: 2026-06-30 date: 2027-12-31 date: 2024-03-26 date: 2024-04-02 name: Jiangsu Simcere Pharmaceutical Co., Ltd. class: INDUSTRY name: Shanghai Xianxiang Medical Technology Co., Ltd. briefSummary: This is an open-label, multicenter Phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0501 in participants with advanced solid tumors. The trial consists two parts, Part 1 for SIM0501 monotherapy and Part 2 for SIM0501 in combination with olaparib. In both parts, SIM0501 with/without olaparib will be administered until disease progression or the investigator determines that continuation of the study drug would not benefit, or there is intolerable toxicity, or the participant or legal representative voluntarily requests withdrawal, or the trial is terminated. conditions: Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 176 type: ESTIMATED name: SIM0501 Tablets name: SIM0501 Tablets name: SIM0501 in combination with olaparib name: SIM0501 in combination with olaparib measure: Dose-limiting toxicity (DLT) measure: Adverse events will be evaluated according to the CTCAE v5.0 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shandong Cancer Hospital status: RECRUITING city: Jinan state: Shandong zip: 250117 country: China name: Jinming Yu role: CONTACT phone: 0531-67626971 email: sdyujinming@126.com lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06331546 id: IRB300004693 id: R01DK137784 type: NIH link: https://reporter.nih.gov/quickSearch/R01DK137784 briefTitle: Gut Oxalate Absorption in Calcium Oxalate Stone Disease overallStatus: RECRUITING date: 2024-05-01 date: 2030-12-31 date: 2031-12-31 date: 2024-03-26 date: 2024-04-03 name: University of Alabama at Birmingham class: OTHER name: University of Texas Southwestern Medical Center name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate kidney stones have an increased absorption of dietary oxalate, which would lead to increased urinary excretion of oxalate.

The study will recruit adult patients with a history of calcium oxalate kidney stones and healthy volunteers without kidney stones.

Participants will

* ingest fixed diets containing low and moderately high amounts of oxalate for 5 days at a time
* ingest a soluble form of oxalate and sugar preparations to test gut permeability
* collect urine, blood, stool and breath sample during the fixed diets and the soluble oxalate test conditions: Kidney Stone conditions: Kidney Calculi conditions: Urolithiasis conditions: Urolithiasis, Calcium Oxalate conditions: Nephrolithiasis conditions: Nephrolithiasis, Calcium Oxalate conditions: Oxalate Urolithiasis conditions: Oxaluria conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 80 type: ESTIMATED name: Low-oxalate diet name: High-oxalate diet name: soluble oxalate gut absorption test measure: Net Gastrointestinal absorption of food-bound oxalate measure: Absorption of soluble 13C2-oxalate measure: Estimated endogenous oxalate synthesis (oxalate mg/day) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham status: RECRUITING city: Birmingham state: Alabama zip: 35294 country: United States name: Sonia Fargue, PhD role: CONTACT phone: 205-975-6932 email: kidneystone@uabmc.edu name: Research Coordinator role: CONTACT phone: 205-9345712 email: kidneystone@uabmc.edu name: Sonia Fargue, PhD role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 facility: UTSW status: ACTIVE_NOT_RECRUITING city: Dallas state: Texas zip: 75390 country: United States lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06331533 id: IstanbulTRH1 briefTitle: Intradermal BoNT-A Treatment in Erythematotelangiectatic Rosacea overallStatus: COMPLETED date: 2022-11-01 date: 2023-05-01 date: 2023-06-01 date: 2024-03-26 date: 2024-03-29 name: Istanbul Training and Research Hospital class: OTHER_GOV briefSummary: Investigation of the effectiveness of intradermal botulinum toxin A treatment in the treatment of erythematotelangiectatic rosacea (ETR) using clinical, biophysical, dermatoscopic and videocapillaroscopy. conditions: Erythematotelangiectatic Rosacea studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Randomized, split face, efficacy study primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Botulinum toxin will be injected into one randomly selected half of the face, and placebo will be injected into the other half of the face. The patient will not know which half of the face was treated. An independent, blinded dermatologist will evaluate the results of the treatment. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Botulinum toxin A name: Placebo measure: Assessment of erythema with Clinician's Erythema Assessment scale measure: Evaluation of erythema using mexameter measure: Evaluation of erythema by dermatoscopy measure: Evaluation of the change in vascular structure using videocapillaroscopy sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Istanbul Training and Research Hospital city: Istanbul zip: 34098 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06331520 id: Desineo briefTitle: NEPA Combined With Olanzapine, Dexamethasone-sparing for the Effect of CINV in Patients Receiving HEC Regimens overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2026-05-01 date: 2024-03-26 date: 2024-03-26 name: Fudan University class: OTHER briefSummary: The objective of this Prospective, randomized, non inferiority phase III trial is to confirm the efficacy and saftey of dexamethasone-sparing combined with netupitant/palonostron and olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy. conditions: Chemotherapy-induced Nausea and Vomiting conditions: Highly Emetogenic Chemotherapy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 627 type: ESTIMATED name: Netupitant / Palonosetron Oral Capsule [Akynzeo] name: Olanzapine name: Dexamethasone Oral measure: Percentage of patients with complete response (CR) measure: Percentage of Patients With CR (acute and delayed) measure: Percentage of patients with overall complete protection(OCP) measure: Percentage of patients with overall total control (OTC) measure: incidence of adverse events measure: quality of life questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06331507 id: HUM00176904 briefTitle: Refinement and Assessment of New MRI Technologies for Cardiovascular Exams Using the Phillips CMR Patch overallStatus: TERMINATED date: 2021-09-02 date: 2023-06-29 date: 2023-06-29 date: 2024-03-26 date: 2024-03-26 name: University of Michigan class: OTHER name: Philips Health Care briefSummary: This study is being done to improve image quality and provide the collaborator with feedback on wide band imaging in patients with cardiac implantable electronic devices (CIED). conditions: Cardiomyopathies studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 292 type: ACTUAL name: CMR patch measure: Scan speed: sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Michigan Medicine - University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06331494 id: SICAS briefTitle: Efficacy of Butylphthalide on Symptomatic Atherosclerotic Stenosis in Middle Cerebral Artery acronym: SICAS overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-05-31 date: 2026-08-31 date: 2024-03-26 date: 2024-03-26 name: First Affiliated Hospital, Sun Yat-Sen University class: OTHER briefSummary: Ischemic stroke with high incidence, mortality, disability and recurrence rate, has become the leading threat to the health worldwide. Intracranial atherosclerotic stenosis (ICAS) is commonly associated with ischemic stroke, especially in Chinese residents. Patients with severe ICAS are subject to a very high risk of recurrent stroke events, despite best medical therapy available. Unstable or complex atherosclerotic plaques can lead to plaque ruptures and distal embolisms, thereby increasing the risk of ischemic stroke recurrence. Studies have shown that activation of inflammatory states may play a driving role in the formation and development of atherosclerosis. So far, it remains unclear which are the best treatments for this condition, especially for high-risk patients. Dl-3-n-butylphthalide (NBP) is a Class I novel drug independently developed in China and was officially approved for use in acute ischemic stroke. Preclinical data showed that NBP can act multiple effects of anti-inflammation, antioxidation and anti-apoptosis by suppressing pro-inflammatory factors and upregulating the expression of anti-inflammatory factors. It is still undetermined whether combined therapy with NBP could enhance the curative effect of intracranial atherosclerosis. The primary purpose of this trial is to evaluate the efficacy of butylphthalide in reducing the degree of arterial stenosis and stabilizing plaques in patients with severe symptomatic middle cerebral artery stenosis. conditions: Ischemic Stroke, Acute conditions: Intracranial Atherosclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: Butylphthalide name: Placebo measure: Changes in stenosis degree in the responsible artery measure: Stroke recurrence measure: Change in plaque volumes the responsible artery measure: Changes in hemorrhage and enhancement volumes of atherosclerotic plaque in the responsible artery measure: Changes in National Institutes of Health Stroke Scale (NIHSS) measure: Proportion of patients with modified Rankin Scale score (mRS) 0-2 measure: Change in the value of cerebral blood flow (CBF) in the responsible artery territory measure: Change in concentrations of serum lipid profiles sex: ALL minimumAge: 55 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital, Sun Yat-sen University city: Guangzhou state: Guangdong zip: 510080 country: China name: Jinsheng Zeng role: CONTACT phone: +8613322800657 email: zengjs@pub.guangzhou.gd.cn name: Shihui Xing role: CONTACT phone: +8613602755395 email: xingshih@mail.sysu.edu.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06331481 id: 0005-22-HYMC briefTitle: The Effect of Over Weight on Oocytes Quality in IVF Patients acronym: IVF overallStatus: ACTIVE_NOT_RECRUITING date: 2022-02-01 date: 2023-12-31 date: 2024-07 date: 2024-03-26 date: 2024-03-26 name: Hillel Yaffe Medical Center class: OTHER_GOV briefSummary: Obesity is an increasing worldwide problem and a risk factor for many diseases. The effect of obesity on female fertility has been extensively tested. Obese women have increased time to pregnancy and remain subfertile even in the absence of ovulatory dysfunction. They present with higher incidence of infertility compared to normal weight women.

This study is prospective observational cohort study performed between February 2022 until June 2022 in a single university-affiliated hospital. conditions: IVF conditions: Overweight studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ACTUAL name: Fullicular fluid for cytology and biocemical analysis measure: Impact of obesity on oocyte's mtDNA expression in Cumulus Cells measure: Impact of obesity on oocyte quality through levels of protein BMP-15 measure: Impact of obesity on oocyte quality through levels of protein HSPG2 measure: Impact of obesity on fertilization and pregnancy rates through analysis of mtDNA expression measure: Impact of obesity on fertilization and pregnancy rates through levels of protein BMP-15 measure: Impact of obesity on fertilization and pregnancy rates through levels of protein HSPG2 sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Hillel Yaffe Medical Center - IVF Unit city: Hadera zip: 38100 country: Israel lat: 32.44192 lon: 34.9039 hasResults: False

 nctId: NCT06331468 id: MCC-23-GYN-10 briefTitle: Hypofractionated Radiochemotherapy overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-08-01 date: 2028-08-01 date: 2024-03-26 date: 2024-03-26 name: Denise Fabian class: OTHER briefSummary: The goal of this clinical trial is to investigate the use of hypofractionated radiation (delivery of fewer but larger doses of radiation) with concurrent chemotherapy for women with metastatic of bulky uterine cervix cancer. The main questions it aims to answer are:

* What is the MRI-assessed rate of response at 1-month and 3-months post-treatment?
* What is the safety and tolerability of cisplatin-based hypofractionated pelvic Intensity Modulated Radiation Therapy (IMRT) followed by brachytherapy?
* What is the median progression-free survival and overall survival at 1 and 2 years for patients who undergo cisplatin-based hypofractionated pelvic IMRT?
* What is the proportion of patients who complete the treatment in prescribed timeframe?
* What the levels of cervix cancer circulating tumor cells pretherapy and after treatment?

To confirm eligibility, within four weeks prior to study enrollment, all patients will undergo the following:

* Complete history and physical exam, GOG performance status evaluation
* Standard of care scans, which include staging CTs and/or PET scans, and MRI to verify eligibility and appropriate stage of disease. Blood tests will be done to check various organ functions.

Treatment will be administered on an outpatient basis.

The main difference between the proposed regimen in the trial and standard of care is as follows:

1. The trial has a shortened course of EBRT. Standard of care utilizes 25 treatments, also known as "fractions" of EBRT, while the trial utilizes 8 fractions of EBRT. An equivalent "biological effective dose" is achieved by increasing the radiation dose per fraction.
2. The concurrent cisplatin dosing is shortened from 5-6 cycles of cisplatin to 2 cycles of cisplatin. The dose of cisplatin is 40 mg/m2.

This protocol requires photon IMRT technique followed by high dose rate (HDR) brachytherapy. The therapies use focused energy beams to kill cancer cells. Radiation therapy must be completed within 30 days +/- 2 days of initiation. Computed tomography simulation with the patient in a head-first laying on back-supine position is required. MRI-guided treatment planning and image guidance during treatment for motion management will be used.

IMRT will be given once daily Monday-Thursday, four fractions per week. The high-dose-rate (HDR) brachytherapy following institutional protocol. Brachytherapy will be delivered twice per week with a 2-day break in between sessions. A total of four brachytherapy treatments will be delivered.

After active therapy is completed, treatment-related toxicity will be assessed at the 1-month post-treatment completion visit and again at the 3-month post-treatment completion. Patients removed from the study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event(s).

Routine MRI imaging to assess treatment response to radiotherapy is conducted at Day 15. Treatment response to radiotherapy followed by brachytherapy will be assessed at the 1- month and 3-months post-treatment completion.

Following the 3-months post-treatment completion, study participants will be followed for disease progression and survival status until Year 2 post-treatment initiation. NOTE: Cervical cancer patients are routinely followed (clinical surveillance) every 3-months during the first two years post-treatment. conditions: Uterine Cervix Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Cisplatin name: intensity modulated radiation therapy (IMRT) name: high-dose-rate (HDR) brachytherapy measure: MRI assessed rate of complete response measure: MRI assessed rate of complete response measure: progression-free survival (PFS) measure: overall survival (OS) measure: Treatment Completion measure: Treatment Tolerability measure: Change in levels of uterine cervix cancer circulating tumor cells sex: FEMALE minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Markey Cancer Center city: Lexington state: Kentucky zip: 40506 country: United States lat: 37.98869 lon: -84.47772 hasResults: False

 nctId: NCT06331455 id: 23-5501 briefTitle: Treatment of Pulmonary SUlcus, Pancoast and Chest Wall Non-small Cell Lung Cancer Employing Radiation, Immuno-oncology and Resection acronym: SUPER overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2026-04 date: 2024-03-26 date: 2024-03-26 name: Marc de Perrot class: OTHER name: Ozmosis Research Inc. briefSummary: The SUPER trial is a prospective Phase II trial. It is designed for patients with stage 2 or 3 non-small cell lung cancer (NSCLC) prior to surgery.

Patients who are enrolled in this trial will receive combination of Non-ablative oligofractionated radiation (NORT) and two cycles of Durvalumab, an immunotherapy drug before their surgery. conditions: Lung Cancer Patients conditions: Non-small Cell Lung Cancer (NSCLC) studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a multi-centre, phase 2 trial in patients with T2b-3N0-1M0 NSCLC evaluating the biologic efficacy of NORT-Durvalumab administered prior to surgery. primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Durvalumab name: Non-ablative oligofractionated radiation (NORT) measure: To Measure CD8 TILs density & Major Pathological Response (MPR) measure: To explore the efficacy and safety of NORT-durvalumab sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06331442 id: 006503905 briefTitle: The Effect of Photodynamic Therapy on Plaque in Orthodontic Patients overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-11 date: 2024-11 date: 2024-03-26 date: 2024-03-26 name: University of Zagreb class: OTHER briefSummary: This randomized controlled trial will be conducted on 40 orthodontic patients at the Department of Orthodontics, University Hospital Centre Zagreb, Croatia. Respondents will be randomly allocated into 4 groups (n=10). The first group will receive photodynamic therapy, the second tricalcium phosphate varnish with 5% NaF (sodium fluoride), the third 1% chlorhexidine varnish, while the fourth group will be the negative control. Before and after the mentioned interventions, the participants will have the amount of plaque measured using the plaque index and the bacteriological composition of the plaque assessed using the mass spectrometry and PCR. The gingival condition will be assessed using the gingival index. Also, the occurrence of white spot lesions will be evaluated on intraoral photographs. conditions: Plaque, Dental conditions: Dental Plaque Induced Gingivitis conditions: White Spot Lesion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Photodynamic therapy name: Tricalcium phosphate (TCP) varnish with 5% NaF name: Chlorhexidine varnish measure: Assessment of dental plaque accumulation using plaque index measure: Assessment of the bacteriological composition of supragingival plaque using mass spectrometry measure: Assessment of the bacteriological composition of subgingival plaque using polymerase chain reaction measure: Assessment of gingival condition using gingival index measure: Diagnosis of white spot lesions on intraoral photographs sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06331429 id: EmoTiCare briefTitle: Emoticare: Serious Game for the Adaptation to the Disease of Adolescents With Type 1 Diabetes Mellitus. overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2024-09 date: 2025-02 date: 2024-03-26 date: 2024-03-28 name: University of Valencia class: OTHER name: Universitat Politècnica de València briefSummary: The intervention program targets adolescents with chronic Type 1 Diabetes Mellitus. Given the critical developmental stage and life transitions, necessitating robust personal resources, psychological support becomes imperative. To foster socioemotional skills and overall well-being, particularly crucial for averting future emotional issues and promoting a healthier, more fulfilling life, this support is especially vital for those dealing with chronic illnesses. Such conditions pose a risk for psychological problems, potentially complicating treatment and prognosis. Presently, digital and technological platforms are integrating psychological interventions for patients with chronic diseases, showcasing an innovative approach to address psychological challenges.

The platform integrates new technologies for assessment and intervention. Ecological Momentary Assessment enables real-time evaluation, with data transferred to the technological platform. Artificial intelligence personalizes interventions based on participants' socio-demographic characteristics and assessment results. Ecological Momentary Intervention is employed for in-context treatments in participants' daily lives and natural environments. A serious game method, proven effective in various interventions, is used to engage adolescents and young people intrinsically. The game encompasses six main areas aligning with theoretical models, facilitating the development of socio-emotional competencies, and promoting physical and psychological health. It addresses different aspects of psychological and subjective well-being, reinforcing resources needed to navigate vital changes in these developmental stages, especially when living with a chronic illness. conditions: Type 1 Diabetes conditions: Adolescent Development studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 200 type: ESTIMATED name: EmoTiCare measure: Change Quality of Life (Baseline-Pre-Post) measure: Change Emotional and Behavioral Problems (Baseline-Pre-Post) measure: Change Emotional Competences (Baseline-Pre-Post) measure: Change Self-concept (Baseline-Pre-Post) measure: Change Coping (Baseline-Pre-Post) measure: Change Social Skills (Baseline-Pre-Post) measure: Change Threat of disease(Baseline-Pre-Post) measure: Change Psychoeducation Diabetes measure: Change Resilience (Baseline-Pre-Post) measure: Glycaemic control (Baseline-Pre-Post) sex: ALL minimumAge: 12 Years maximumAge: 16 Years stdAges: CHILD facility: Universitat de València city: Valencia country: Spain name: Marián Pérez-Marín, PhD role: CONTACT phone: 963983392 email: marian.perez@uv.es name: Selene Valero Moreno, PhD role: SUB_INVESTIGATOR name: Inmaculada Montoya-Castilla, PhD role: SUB_INVESTIGATOR name: Javier Martín Ávila, MsC role: SUB_INVESTIGATOR name: Esther Rodríguez-Jiménez, MsC role: SUB_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06331416 id: 208_2022H briefTitle: One-device Multiparametric Home Telemonitoring of Patients With Chronic Obstructive Pulmonary Disease Exacerbation overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-09-30 date: 2024-03-26 date: 2024-03-26 name: University of Trieste class: OTHER briefSummary: Chronic obstructive pulmonary disease (COPD) exacerbations are risk factors for disease progression and short-term re- hospitalizations. We propose a randomized controlled trial to evaluate the efficacy of a one-device multiparameter telemonitoring in reducing functional decline, symptoms, and risk of re-hospitalization of patients discharged after hospitalization for exacerbated COPD. conditions: COPD conditions: COPD Exacerbation Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Open-label randomized controlled trial, allocation ratio 1:1 primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 60 type: ESTIMATED name: Telemonitoring measure: Re-hospitalization at 90 days measure: Re-hospitalization at 30 days measure: Functional decline measure: Unplanned medical evaluations measure: Need for mechanical ventilation at 30 days measure: Need for mechanical ventilation at 90 days measure: Satisfaction score sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06331403 id: 24-009 briefTitle: Open Pilot Trial of a Mind-Body Sexual Well-Being Intervention for Female GI Cancer Survivors overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-03-26 date: 2024-03-26 name: Massachusetts General Hospital class: OTHER name: Harvard Medical School (HMS and HSDM) briefSummary: The primary goal of this protocol is to conduct an open pilot to collect initial quantitative and qualitative feedback on the intervention that the investigators are developing. To do so, the investigators will deliver a newly-developed intervention to up to 2 consecutive groups of female colorectal and anal cancer survivors (n = up to 10 per group, total N = up to 20). Participants will provide feedback regarding intervention acceptability, feasibility, and perceived benefit.

To inform plans for ongoing program refinement, the investigators will elicit specific feedback about study assessment tools, recruitment procedures, and group factors. Given the early-stage, open pilot nature of this protocol, the investigators will not set strict criteria to establish feasibility and acceptability but will rather interpret each of these outcomes holistically. Qualitative feedback collected in post-intervention exit interviews will also support understanding of feasibility and acceptability.

As a secondary aim, the investigators will explore the preliminary effects of the intervention on psychosocial measures of satisfaction with sexuality and impact of functional limitations, coping abilities, acceptance of body image changes, loneliness, and anticipated stigma. As noted above, the investigators will not set specific criteria to establish preliminary efficacy, nor will they consider statistical significance as an indicator of the study's efficacy for these outcomes. Instead, the investigators will consider pre-post intervention effect sizes to consider the need for refinement of study procedures/measurement in a future larger trial.

In future, larger-scale, work, the investigators intend to conduct a larger randomized pilot trial to assess intervention acceptability, feasibility, as well as preliminary efficacy on essential outcomes related to sexual well-being. conditions: Colorectal Cancer conditions: Anal Cancer conditions: Sexual Dysfunction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Mind-Body Group Intervention measure: Feasibility of Intervention measure: Acceptability of Intervention sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06331390 id: 2181-198-03-04-24-0008 briefTitle: Assessment of Niacinamide Cosmetic Product Efficacy in Model of Irritant Contact Dermatitis overallStatus: RECRUITING date: 2024-04 date: 2024-06 date: 2024-07 date: 2024-03-26 date: 2024-03-26 name: University of Split, School of Medicine class: OTHER briefSummary: Testing the effectiveness and safety of cosmetics with niacinamide in irritant contact dermatitis: A Randomised, Controlled Trial will be conducted at USSM. Healthy volunteers will be included (at least 25) and test sites are forearms. Sodium lauryl sulphate will be used to induce contact dermatitis and participants will be measured for 7 days conditions: Contact Dermatitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 25 type: ESTIMATED name: niacinamide cosmetic product name: placebo measure: tewameter sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of Split School of Medicine status: RECRUITING city: Split country: Croatia name: Josipa Bukic role: CONTACT phone: 00385917933752 email: jbukic@mefst.hr lat: 43.50891 lon: 16.43915 hasResults: False

 nctId: NCT06331377 id: 17-004541 id: NCI-2024-01765 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 17-004541 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: Clinical and Molecular Characteristics of Histiocytic Disorders overallStatus: RECRUITING date: 2017-07-27 date: 2027-07-31 date: 2027-07-31 date: 2024-03-26 date: 2024-03-26 name: Mayo Clinic class: OTHER briefSummary: This study is being done to collect medical and personal histories as well as a samples of blood, other body fluid and/or tumor/disease tissue for current and future research studies on histiocytic disorders. conditions: Histiocytic Disorder studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 500 type: ESTIMATED name: Non-Interventional Study measure: Identify molecular markers measure: Change in PD-L1 and T-cell Bim expression sex: ALL minimumAge: 1 Year stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Ronald S. Go, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06331364 id: Pro00114347 id: R01AI168420 type: NIH link: https://reporter.nih.gov/quickSearch/R01AI168420 briefTitle: TREATment of Lower Respiratory Tract Infection in Sri Lanka (TREAT-SL) acronym: TREAT-SL overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2026-04 date: 2024-03-26 date: 2024-03-26 name: Duke University class: OTHER name: National Institute of Allergy and Infectious Diseases (NIAID) briefSummary: This is a stepped-wedge, cluster-randomized, two-arm, open-label, clinical trial of an electronic clinical decision support tool (eCDST) for the diagnosis and treatment of lower respiratory tract infection (LRTI) among patients at three sites in Southern Province, Sri Lanka.

The primary objective of this trial is to determine the impact of an electronic clinical decision support tool (eCDST) on clinical outcomes and antibacterial prescription in subjects with LRTI in the intervention group compared to the control group.

The study will enroll 765 patients ≥ 14 years of age. Medical wards will be randomized in clusters to the intervention at intervals of 3-6 months until all clusters cross over. Participants will be followed for 30 days from enrollment to record clinical outcomes and any antimicrobials prescribed. conditions: Lower Resp Tract Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: stepped-wedge, cluster randomized, two-arm, open label

This design combines elements of a cluster randomized trial (intervention is applied in clusters) and a before-after design (each cluster switches to intervention). All 9 pairs of wards (clusters) will start with an initial period of usual care. At intervals of 3-6 months (steps), a set of 3 pairs of wards (clusters) will switch in a randomized order to use the intervention, until all pairs of wards have crossed over. primaryPurpose: TREATMENT masking: NONE count: 765 type: ESTIMATED name: electronic clinical decision support tool (eCDST) diagnostic plan measure: Total duration of antibacterial prescription for the index visit measure: Composite of adverse outcomes that could be attributed to withholding antibacterials measure: Proportion of participants using non-invasive ventilation measure: Proportion of participants using mechanical ventilation measure: Proportion of participants readmitted to the hospital measure: Proportion of deaths measure: Proportion of participants seeking subsequent outpatient care for the LRTI illness and receiving an antibacterial prescription measure: Proportion of participants admitted to the intensive care unit (ICU) during index hospitalization measure: Duration of admission to the intensive care unit (ICU) during index hospitalization measure: Number of participants requiring use of supplemental oxygen by nasal cannula or face mask during index hospitalization measure: Duration of supplemental oxygen by nasal cannula or face mask during index hospitalization measure: Duration of non-invasive ventilation during index hospitalization measure: Duration of mechanical ventilation during index hospitalization measure: Duration of index hospitalization measure: Proportion prescribed antibacterials- cumulative measure: Proportion prescribed antibacterials- at time of assessment measure: Total antibacterial exposure per patient during hospitalization measure: Proportion prescribed oseltamivir- cumulative measure: Proportion prescribed oseltamivir- at time of assessment measure: Total oseltamivir exposure per patient during hospitalization measure: Proportion prescribed SARS-CoV-2 antivirals during hospitalization- cumulative measure: Proportion prescribed SARS-CoV-2 antivirals during hospitalization- at time of assessment measure: Physician adherence, as measured by proportion in whom the first recommended diagnostic test (if recommended) was performed measure: Physician adherence, as measured by the proportion in whom the second recommended diagnostic test (if recommended) was performed measure: Physician adherence, as measured by proportion in whom the antibacterial treatment recommendation was followed measure: Physician adherence, as measured by the proportion in whom the oseltamivir treatment recommendation was followed measure: Physician adherence, as measured by the proportion in whom all treatment recommendations were followed sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06331351 id: A11203001 briefTitle: Effect of Jing Si Herbal Tea Liquid Packets on Chronic Pharyngolaryngitis overallStatus: RECRUITING date: 2024-02-22 date: 2025-10-31 date: 2025-12-31 date: 2024-03-26 date: 2024-03-26 name: Dalin Tzu Chi General Hospital class: OTHER briefSummary: Chronic pharyngolaryngitis is common and often make people suffer in many aspects. The etiology is numerous, for example, airway hypersensitivity, gastroesophageal acid regurgitation, sicca syndrome, anxiety, etc.

The investigators aimed to investigate the effect of Jing Si herbal tea liquid packets on chronic pharyngolaryngitis by a design of randomized, double-blind clinical trial in this study. The subjects who were bed-ridden, without self-care ability, receiving hemodialysis, no idea about the details of this study, poor compliance for this study, alcohol and/or drugs additives, pregnancy and breast-feeding women were excluded from this study.

A questionnaire for health and habits was performed at the start of the study, and a questionnaire for Reflux Symptom Index (RSI) was performed at the start and the end of the study. Finally, Student's t-test was used to test the difference between the Jing Si herbal tea group and the control group. And, multivariate linear regression was used to test the violation of clinical factors on the treatment outcome of Jing Si herbal tea liquid packets on chronic pharyngolaryngitis. conditions: Chronic Pharyngitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 120 type: ESTIMATED name: control group name: Jing Si herbal tea liquid packets measure: Health questionnaire measure: Reflux Symptom Index (RSI) sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation status: RECRUITING city: Chiayi City zip: 66247 country: Taiwan name: Juen-Haur Hwang, MD, PhD role: CONTACT phone: +886-5-2648000 phoneExt: 5239 email: g120796@tzuchi.com.tw lat: 23.47917 lon: 120.44889 hasResults: False

 nctId: NCT06331338 id: 202310085RIND briefTitle: Effects of Using Decision Cycle for Person-Centered Glycemic Management in Type 2 Diabetes overallStatus: RECRUITING date: 2024-02-14 date: 2024-10-31 date: 2025-12-31 date: 2024-03-26 date: 2024-04-01 name: National Taiwan University Hospital class: OTHER briefSummary: Decision cycle for person-centered glycemic management is a new diabetes decision making .It is defined as a purposefully designed holistic care intervention .The goal is to improve the self-care behavior of patients with type 2 diabetes, thereby improving glycated hemoglobin levels and delaying the occurrence of complications. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 130 type: ESTIMATED name: Decision Cycle for Person-Centered Glycemic Management name: Traditional diabetes self-management education measure: glycemic control (HbA1c) measure: Diabetes Self-Care Behavior Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital status: RECRUITING city: Hsinchu zip: 302 country: Taiwan name: Chia-Hui Tsai role: CONTACT phone: 886926124093 email: mtsai0322@gmail.com lat: 24.80361 lon: 120.96861 hasResults: False

 nctId: NCT06331325 id: 724 briefTitle: Comparison of Frenotomy and Frenectomy Techniques for Management of High Frenum Attachment in Adults overallStatus: RECRUITING date: 2024-03-20 date: 2024-09-30 date: 2024-09-30 date: 2024-03-26 date: 2024-03-26 name: October University for Modern Sciences and Arts class: OTHER briefSummary: The goal of this randomized clinical trial is to compare frenotomy to frenectomy surgical techniques in the management of high frenum attachment in adults. The main questions it aims to answer are:

* Does Frenotomy procedure have a lower relapse rate compared to frenectomy?
* Does Frenotomy procedure result in fewer postoperative complications? Participants will be divided into two groups. The intervention group will involve frenotomy procedure for participants and will be compared to the traditional frenectomy procedure in the comparator group. The level of the frenum will be measured at baseline and after 6 months. Pain scores will be recorded by the participants during the first week. conditions: High Frenum Attachment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized clinical trial. Allocation Ratio: 1:1 primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants and outcome assessors will be unaware of the recruitment group. The allocation sequence will be contained within sequentially numbered, opaque, sealed packets that the patients will pull. According to the randomization table, the written number on the paper will allocate the patient to the intervention or control group. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 46 type: ESTIMATED name: Frenotomy name: Frenectomy measure: Rebound / Relapse. measure: Postoperative pain sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: MSA University status: RECRUITING city: Giza zip: 12566 country: Egypt name: Nada Zazou role: CONTACT phone: +201224016945 email: drzazou@hotmail.com lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06331312 id: CAIN457C22301E1 id: 2023-508077-85-00 type: OTHER domain: EU CT number briefTitle: Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR) acronym: REPLENISH-EXT overallStatus: RECRUITING date: 2024-04-10 date: 2028-03-13 date: 2028-05-08 date: 2024-03-26 date: 2024-04-16 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this extension study is to assess the safety and tolerability of secukinumab when administered long-term in patients with polymyalgia rheumatica. conditions: Polymyalgia Rheumatica studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Secukinumab measure: Incidences of treatment emergent adverse events (AEs) and serious adverse events (SAEs) sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Novartis Investigative Site status: RECRUITING city: Parramatta zip: 2150 country: Australia lat: -33.81667 lon: 151.0 hasResults: False

 nctId: NCT06331299 id: BL013 briefTitle: A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer acronym: UTOPIA overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-03 date: 2026-03 date: 2024-03-26 date: 2024-04-19 name: UroGen Pharma Ltd. class: INDUSTRY briefSummary: This Phase 3, single-arm, multicenter study will evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with low-grade non-muscle invasive bladder cancer (LG-NMIBC). conditions: Bladder Cancer conditions: Urothelial Carcinoma conditions: Urothelial Carcinoma Bladder studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 87 type: ESTIMATED name: UGN-103 measure: Complete response rate (CRR) measure: Duration of response (DOR) measure: Durable complete response (DCR) rate measure: Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest, and abnormal clinical laboratory test results (hematology and serum chemistry) measure: Mitomycin plasma concentrations measure: Mitomycin maximum plasma concentration (Cmax) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06331286 id: IIT20230091C-R1 briefTitle: The Effect of Dulaglutide as an Adjuvant Therapy on Cognitive Function in Bipolar Disorder Patients With Obesity overallStatus: RECRUITING date: 2023-09-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-26 date: 2024-03-26 name: First Affiliated Hospital of Zhejiang University class: OTHER briefSummary: The primary objective of this study is to investigate the effect of dulaglutide adjuvant treatment in patients with bipolar disorder with obesity, in addition to exploring the effect of GLP-1RA on cognition of bipolar disorder. conditions: Bipolar Disorder conditions: Obesity conditions: Cognition studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: dulaglutide injection measure: weight measure: Concentration of blood glucose in blood measure: Concentration of total cholesterol in blood measure: Concentration of high density lipoprotein in blood measure: Concentration of low density lipoprotein in blood measure: Concentration of triglyceride in blood measure: CBCT test results measure: 17-item Hamilton Depression Rating Scale (HAM-D17) Score measure: Treatment Emergent Symptom Scale (TESS) Score sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Psychiatry, First Affiliated Hospital of Zhejiang University status: RECRUITING city: Hangzhou state: Zhejiang zip: 310000 country: China name: Hu ShaoHua role: CONTACT phone: 13957162903 email: dorhushaohua@zju.edu.cn lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06331273 id: CT2024-ZJU-OBS3 briefTitle: Impact of "No-touch" Technique on the Outcome of Liver Transplantation for Hepatocellular Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-04-01 date: 2028-04-01 date: 2024-03-26 date: 2024-03-26 name: Zhejiang University class: OTHER name: Shulan (Hangzhou) Hospital briefSummary: The "no-touch" technique has been one of the most important principles of oncological surgery and aimed to prevent seeding and tumor cell dissemination. Previous studies in hepatectomy have shown that no-touch technique surgery can reduce HCC recurrence and improve the survival of patients. However, there is no consensus on whether the no-touch technique in LT for HCC improves the outcomes. This study aims to prospectively include liver transplant patients from multiple transplant centers, collecting their pre-transplant clinical information, post-transplant pathological records and exploring and clarify the correlation between "no-touch" technique and the prognosis of LT patients. conditions: Liver Transplantation conditions: No-touch Technique conditions: Hepatocellular Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 800 type: ESTIMATED name: Liver transplantation with "No-touch" technique measure: Recurrence free surviavl rate measure: Overall survival rate measure: Tumor recurrence rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06331260 id: CT2024-ZJU-OBS2 briefTitle: Assessment of AFP and PIVKA-II as Prognostic Indicators in Liver Transplantation for Hepatocellular Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-04-01 date: 2028-04-01 date: 2024-03-26 date: 2024-03-26 name: Zhejiang University class: OTHER name: Shulan (Hangzhou) Hospital briefSummary: As key biomarkers in HCC, AFP and PIVKA-II reflects biological features of tumor and has been widely applied for clinical diagnosis. Previous studies reported preoperative AFP and PIVKA-II are related to HCC recipient long-term survival after liver transplantation. However, there is no prospective study supporting these conclusions. This study aims to prospective collect liver transplantation cases from multiple transplant centers and further evaluate the prognostic role of preoperative AFP and PIVKA-II in liver transplantation for HCC. conditions: Liver Transplantation conditions: Hepatocellular Carcinoma conditions: Alpha-Fetoprotein conditions: Protein Induced by Vitamin K Absence or Antagonist-II studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED measure: Recurrence free survival rate measure: Overall survival rate measure: Tumor recurrence rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06331247 id: 20230520-2 briefTitle: MIND Diet to Improve Cognitive Function in Mild Stroke Patients (MINDICOMS) II overallStatus: RECRUITING date: 2024-03-18 date: 2025-12-31 date: 2025-12-31 date: 2024-03-26 date: 2024-04-04 name: Zhejiang University class: OTHER briefSummary: A 6-month pilot randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet + usual medical care versus usual medical care on cognitive change and several other secondary outcomes through a randomized controlled trial in 60 mild stroke patients aged 35-70 years without dementia. conditions: Dementia conditions: Stroke conditions: Cognitive Change conditions: Cerebrovascular; Disorder, Thrombotic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a two-arm parallel design, with one arm being the control arm (usual medical care) and the other being the intervention arm (MIND diet intervention + usual medical care). primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The outcome assessors will be masked from the assignment of the participants. whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: General dietary advice name: Localized MIND diet intervention name: Routine medical care measure: Change in global cognitive function measure: Change in MIND diet score measure: Change in Montreal Cognitive Assessment (MoCA) score measure: Change in Mini-Mental State Examination (MMSE) score measure: Change in brain MRI markers measure: Change in memory function measure: Change in language function measure: Change in executive function measure: Change in visuospatial function measure: Change in the ability of daily life measured using the Activities of Daily Living Scale (ADL) measure: Change in the ability of daily life measured using the Instrumental Activities of Daily Living Scale (IADL) measure: Change in depressive status measured using the Patient Health Questionnaire (PHQ-9) measure: Change in anxiety status measured using the General Anxiety Disorder-7 (GAD-7) measure: Changes in plasma metabolic profiles measured using metabolome analysis measure: Changes in plasma inflammatory biomarker panel measure: Changes in the intestinal microbiome sex: ALL minimumAge: 35 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Second Affiliated Hospital, Zhejiang University School of Medicine status: RECRUITING city: Hangzhou state: Zhejiang zip: 310058 country: China name: Lusha Tong, PhD role: CONTACT lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06331234 id: VCI briefTitle: Effects of Vena Cava Inferior Measurements on AKI and Mortality. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-01 date: 2024-12-01 date: 2024-03-26 date: 2024-04-23 name: Inonu University class: OTHER briefSummary: Fluid overload is harmful in critically ill patients; In addition to increasing mortality, it may increase the incidence of acute kidney injury (AKI), length of ICU stay, and duration of mechanical ventilation by causing end-organ damage. (1-3) Mortality attributable to AKI is 20% and is an independent determinant of mortality. (4) Venous load ultrasonography score (VExUS) is a new systemic congestion scoring method based on inferior vena cava dilation and pulsed wave Doppler (PW-Doppler) morphology of the hepatic, portal and renal veins. It has been proposed as a score to assess systemic congestion. When the IVC diameter is \< 2 cm, it means there is no congestion and VEXUS is 0. Mild congestion: In addition to the IVC measuring approximately 2 cm, normal patterns such as the systolic wave being greater than the diastolic wave in the hepatic vein PW-doppler, pulsatility below 30% in the portal vein Doppler, continuous flow in the renal vein PW-doppler, or slightly abnormal patterns, i.e. hepatic The systolic wave in vein PW-doppler is smaller than the diastolic wave, the pulsatility in portal PW-doppler is between 30-50%, and the renal vein PW-doppler is accompanied by biphasic flow, and VEXUS is scored as 1. Moderate congestion is scored as VEXUS 2, which is measured as IVC 2 cm or more, plus inversion of the systolic wave on hepatic vein PW-doppler, pulsatility greater than 50% on portal PW-doppler, and discontinuous monophasic flow with only the diastolic phase on renal vein PW-doppler. It is accompanied by one of the serious abnormal patterns such as There is severe congestion, that is, VEXUS 3: IVC diameter of 2 cm or more and the presence of at least two seriously abnormal PW-Doppler morphologies. (5) The primary aim of this study is to describe the prevalence of venous congestion based on VExUS in general ICU patients. Secondary outcomes were to evaluate the association between VExUS, AKI, and 28-day mortality. conditions: Intensive Care Unit conditions: Acute Kidney Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Vena cava inferior diameter measure: acute kidney injury measure: mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06331221 id: JSA_Fatigue_FADEUP briefTitle: Effects of Different Concentric and Eccentric Muscle Fatigue Protocols on the Knee Joint Position Sense overallStatus: RECRUITING date: 2023-11-02 date: 2024-05-15 date: 2024-06-01 date: 2024-03-26 date: 2024-03-26 name: Universidade do Porto class: OTHER briefSummary: The aim of this study was to investigate the effects of different concentric and eccentric muscle fatigue protocols on the knee joint position sense of healthy individuals. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 20 type: ESTIMATED name: Muscle fatigue Protocol measure: Absolute angular error measure: Relative angular error measure: Variable angular error sex: MALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Faculdade de Desporto, Universidade do Porto status: RECRUITING city: Porto zip: 4200 country: Portugal name: Joana Azevedo, MSc role: CONTACT phone: +351917910094 email: azevedojoana311@gmail.com lat: 41.14961 lon: -8.61099 hasResults: False

 nctId: NCT06331208 id: LUNG-HF:16181/21; G-21-57 briefTitle: Mechanisms of Pulmonary Vascular Dysfunction in Heart Failure acronym: LUNG-HF overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-30 date: 2026-12-30 date: 2024-03-26 date: 2024-03-26 name: Institute for Clinical and Experimental Medicine class: OTHER_GOV briefSummary: Heart failure (HF) patients often develop pulmonary hypertension (PH) that leads to transition into a biventricular HF with poor prognosis.

There are two PH components: 1) passive transmission of increased left atrial pressure, 2) heart failure (HF) related pulmonary vascular dysfunction (PVD) with increased vascular resistance. Intriguingly, only some, but not all HF patients develop heart failure-related PVD. The mechanisms and non-invasive detection of HF-PVD are poorly understood and are the focus of the current grant application. Development of PVD is linked to insufficiently characterized metabolic factors that may be mediators of HF-PVD.

Untargeted metabolomics is an emerging powerful platform for the discovery of pathways linked to diseases. Its specificity can be further enhanced using transpulmonary gradient sampling.

Part A of the project aims to identify novel metabolites associated with the presence of PVD in patients with HF that can serve as biomarkers or targets and will provide biologic insights into PVD. Part C will assess the effects of reverting of metabolic alterations (identified in part A) by a drug/diet on pulmonary vasculature in experimental HF-related PVD. The "gold standard" for the detection of PVD is right heart catheterization, which is invasive and risky. Heart failure-related PVD is therefore often diagnosed late.

There is a need for noninvasive tests that may help to detect PVD in early stages and can be done repeatedly. Recent advances in artificial intelligence (AI)-assisted automated quantitative analysis of lung texture from low-dose contrast-free high-resolution CT images allow to quantify lung water content, interstitial changes or vessel volume, and may provide clues for detection of heart failure-related PVD. Such an approach, not tested yet, will be utilized for the detection of HF-PVD (part B). Clinical and functional characteristics of lung circulation (exercise hemodynamics, diffusion capacity, perfusion) will be analyzed in relation to quantitative CT data. conditions: Heart Failure conditions: Pulmonary Hypertension conditions: Pulmonary Vascular Resistance Abnormality studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 230 type: ESTIMATED name: non-contrast chest CT name: spirometry with diffusing lung capacity for carbon monoxide (DLCO) analysis name: Omics analysis of blood plasma obtained from pulmonary artery or peripheral blood name: supine bike exercise during right heart catheterisation name: Lung ventilation/perfusion SPECT measure: biomarker of pulmonary vasculopathy in HF measure: CT characteristics of pulmonary vasculopathy in HF measure: CT characteristics of presence of heart failure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Clinical and Experimental Medicine - IKEM city: Prague zip: 140 21 country: Czechia name: Vojtech Melenovsky, MD, PhD role: CONTACT phone: 420 236055190 email: vome@ikem.cz lat: 50.08804 lon: 14.42076 hasResults: False

 nctId: NCT06331195 id: DICA-HF_MAIN briefTitle: An Adapted Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Familial Hypercholesterolemia (DICA-FH) acronym: DICA-FH overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-12 date: 2024-03-26 date: 2024-03-26 name: Hospital do Coracao class: OTHER name: University of Sao Paulo name: National Institute of Cardiology, Laranjeiras, Brazil name: Instituto Dante Pazzanese de Cardiologia briefSummary: The main objective of this randomized clinical trial is to evaluate the effects of the adapted Brazilian Cardioprotective Diet (DICA Br) supplemented or not with phytosterols and/or krill oil in patients with a probable or definitive diagnosis of familial hypercholesterolemia (FH) according to the the Dutch Lipid Clinic Network (Dutch MEDPED) criteria. In addition, the following will be considered secondary objectives: to perform participants´ whole genome sequencing (WGS); to evaluate the effects of the interventions on lipid profile biomarkers; to evaluate the frequency of mild, moderate and severe adverse events according to study groups; to identify the prevalence of subclinical atherosclerosis; to perform pharmacogenomic analysis; and to evaluate adherence rates according to study groups. In this study, 300 individuals will be randomly enrolled into four groups: 1) DICA Br adapted to the FH context (DICA-FH) + phytosterol placebo + krill oil placebo (control group); 2) DICA-FH + 2g/day of phytosterol + krill oil placebo; 3) DICA-FH + phytosterol placebo + 2g/day of krill oil; and 4) DICA-FH + 2g/day of phytosterol + 2g/day of krill oil.

Primary outcomes will be LDL-cholesterol for groups phytosterol vs. placebo and lipoprotein(a) for groups krill oil vs. placebo after 120 days of follow up. conditions: Familial Hypercholesterolemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Placebo phytosterol name: Placebo krill oil name: Phytosterol name: Krill oil measure: LDL-c measure: Lp(a) measure: TC measure: HDL-c measure: TG measure: VLDL measure: NHDL measure: CI I measure: CI II measure: TG/HDL-c measure: AI measure: ox-LDL measure: APOAI measure: APOB100 measure: AE measure: Adherence sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06331182 id: 36264PR552/2/24 briefTitle: Dexmedetomidine and Ketamine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain overallStatus: RECRUITING date: 2024-03-26 date: 2024-08-01 date: 2024-08-01 date: 2024-03-26 date: 2024-03-27 name: Tanta University class: OTHER briefSummary: The aim of this study is to compare the role of dexmedetomidine and ketamine as an adjuvant in external oblique intercostal plane block for post thoracotomy pain. conditions: Dexmedetomidine conditions: Ketamine conditions: External Oblique Intercostal Plane Block conditions: Post Thoracotomy Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Ketamine name: Dexmedetomidine name: Bupivacaine measure: Time to the 1st rescue analgesia measure: Intraoperative fentanyl consumption measure: Total morphine consumption in the 1st 24hr and 48 hr measure: Degree of pain measure: Heart rate measure: Mean arterial blood measure: The incidence of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tanta University status: RECRUITING city: Tanta state: ElGharbia zip: 31527 country: Egypt name: Mohammed S Elsharkawy, MD role: CONTACT phone: 00201148207870 email: mselsharkawy@med.tanta.edu.eg name: Saad A Moharam, MD role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06331169 id: ALTER-BC-Ib-01 briefTitle: Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2027-06-30 date: 2024-03-26 date: 2024-03-26 name: Fudan University class: OTHER briefSummary: A Prospective Phase Ib Study of Anlotinib with Trastuzumab Deruxtecan for HER2-Low Unresectable and/or Metastatic Breast Cancer conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: Anlotinib name: Trastuzumab deruxtecan measure: Determination of the RP2D of anlotinib in combination with trastuzumab deruxtecan measure: Objective Response Rate (ORR) measure: Duration of Response (DCR) measure: Duration of Response (DOR) measure: Progression-free Survival (PFS) measure: Overall Survival (OS) measure: Number of Participants With Adverse Events (AEs) sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jian Zhang city: Shanghai state: Shanghai zip: 200433 country: China name: Jian Zhang, MD,PhD role: CONTACT phone: +8664175590 phoneExt: 85000 email: syner2000@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06331156 id: 218485 id: 2022-000708-36 type: EUDRACT_NUMBER briefTitle: A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Human Rotavirus (HRV) Porcine Circovirus (PCV)-Free Vaccine in Healthy Chinese Infants overallStatus: RECRUITING date: 2024-03-22 date: 2024-11-19 date: 2024-11-19 date: 2024-03-26 date: 2024-04-24 name: GlaxoSmithKline class: INDUSTRY briefSummary: The purpose of this study is to evaluate the immune response and safety of the inactivated poliovirus (IPV) vaccine when co-administered with the human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in healthy Chinese infants 6-10 weeks of age at the time of study enrolment. conditions: Gastroenteritis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 400 type: ESTIMATED name: HRV PCV-free name: IPV measure: Percentage of participants with seroconversion for anti-poliovirus types 1, 2 and 3 neutralizing antibody (Ab) measure: Anti-poliovirus types 1, 2 and 3 neutralizing Ab geometric mean titers (GMTs) measure: Percentage of participants with anti-poliovirus types 1, 2 and 3 neutralizing Ab titers >=1:8 and >=1:64 measure: Percentage of participants with seroconversion for anti-rotavirus (RV) immunoglobulin A (IgA) Ab measure: Anti-RV IgA Ab geometric mean concentrations (GMCs) measure: Percentage of participants with anti-RV IgA Ab concentrations >= 90 U/mL measure: Percentage of participants reporting solicited systemic events measure: Percentage of participants reporting unsolicited adverse events (AEs) measure: Percentage of participants reporting serious adverse events (SAEs) sex: ALL minimumAge: 6 Weeks maximumAge: 10 Weeks stdAges: CHILD facility: GSK Investigational Site status: RECRUITING city: Chengdu state: Sichuan zip: 610041 country: China name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Xuecheng Liu role: PRINCIPAL_INVESTIGATOR lat: 30.66667 lon: 104.06667 facility: GSK Investigational Site status: RECRUITING city: Guang'an state: Sichuan zip: 638300 country: China name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Xuecheng Liu role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site status: RECRUITING city: Neijiang state: Sichuan zip: 641200 country: China name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Yulin Jing role: PRINCIPAL_INVESTIGATOR lat: 29.58354 lon: 105.06216 facility: GSK Investigational Site status: RECRUITING city: Wenshan state: Yunnan zip: 663300 country: China name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Xiaoqiang Liu role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site status: RECRUITING city: Wenshan zip: 663100 country: China name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Xiaoqing Liu role: PRINCIPAL_INVESTIGATOR hasResults: False

 nctId: NCT06331143 id: 36264PR551/2/24 briefTitle: Analgesic Efficacy of Mid-Transverse Process to Pleura (MTP) Block and Intrathecal Morphine in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion overallStatus: RECRUITING date: 2024-03-28 date: 2024-09-01 date: 2024-09-01 date: 2024-03-26 date: 2024-03-29 name: Tanta University class: OTHER briefSummary: The aim of this study is to compare the analgesic efficacy of mid-transverse process to pleura (MTP) block and intrathecal morphine in idiopathic scoliosis patients undergoing posterior spinal fusion surgery. conditions: Mid-Transverse Process Block conditions: Intrathecal Morphine conditions: Idiopathic Scoliosis conditions: Posterior Spinal Fusion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Ultrasound-Guided Mid-Transverse Process to Pleura (MTP) Block name: Morphine measure: Degree of pain measure: Heart rate measure: Mean arterial pressure measure: Patient satisfaction measure: Complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tanta University status: RECRUITING city: Tanta state: ElGharbia zip: 31527 country: Egypt name: Mohammed S Elsharkawy, MD role: CONTACT phone: 00201148207870 email: mselsharkawy@med.tanta.edu.eg name: Saad A Moharam, MD role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06331130 id: 6363 briefTitle: Mesenteric Infiltration in Ovarian Cancer acronym: MIO overallStatus: RECRUITING date: 2024-03-01 date: 2025-06-30 date: 2025-12-31 date: 2024-03-26 date: 2024-03-26 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER name: Danube University Krems name: Institut du Cancer de Montpellier - Val d'Aurelle name: Ente Ospedaliero Cantonale, Ticino, Switzerland briefSummary: To evaluate if CT features at diagnosis in patients with HGSOC can be used to build an Artificial Intelligence model capable of discerning the pathological involvement of the mesentery, assessing the potential impediments for an optimal debulking surgery and predicting the development of resistance to platinum based chemotherapeutic agents. conditions: Ovary Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 510 type: ESTIMATED name: Computed Tomography measure: Preoperative Artificial Intelligence assisted CT-based evaluation measure: Evaluation of the Radiologist Assessment of the CT measure: Prediction of Platinum Resistance measure: Prediction of Progression Free Survival (PFS) and Overall Survival (OS) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Advanced Radiology Center status: RECRUITING city: Roma zip: 00168 country: Italy name: Camilla Panico, MD role: CONTACT phone: +390630158637 email: camilla.panico@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06331117 id: 3776 briefTitle: Effect of RAS/MAPK Pathway Hyperactivation on Growth' and Bone' Profile of the RASopathies acronym: 3776 overallStatus: RECRUITING date: 2021-04-22 date: 2021-12-22 date: 2026-04-22 date: 2024-03-26 date: 2024-03-26 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Costello syndrome (CS) and cardio-facio cutaneous syndrome (CFCS) belongs to RASopathies, a group of multisystemic disorders caused by unregulated signalling through the RAS/MAPK pathway, an intracellular signalling pathway regulating multiple processes such as cellular proliferation, differentiation, survival, apoptosis and also contributing to oncogenesis. They share a recognizable facial appearance, aged appearance, growth delay, muscle-skeletal anomalies, heart defects, neuropsychological features, skin and ocular abnormalities, and cancer predisposition.

Even though life expectancy of individuals with CS and CFCS has increased in the last years due to the improvement of patients' care and a more effective prevention of comorbidities, some of the most challenging aspects impacting on everyday living such as growth failure, accelerate senescence and skeletal-muscle defects, still need to be fully understood. This statement underlies the need to improve clinical research protocols with more innovative techniques (multi-omics profiling) in order to better understand the effect of RAS/MAPK pathway hyperactivations on different systems and to define possible personalized treatments. conditions: RASopathy conditions: Costello Syndrome conditions: Noonan Syndrome conditions: Cardio-Facio-Cutaneous Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 120 type: ESTIMATED name: Diagnostic test measure: Metabolomic profile of the RASopathies sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Woman and Child Health and Public Health, Fondazione Policlinico A. Gemelli, IRCCS status: RECRUITING city: Roma zip: 00168 country: Italy name: Chiara Leoni, MD, PhD role: CONTACT phone: 0039063381344 email: chiara.leoni@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06331104 id: ChangyeZou briefTitle: Network Pharmacology Prediction: Mechanism Study of Puerarin in the Treatment of Giant Cell Tumors of Bone overallStatus: COMPLETED date: 2012-06-14 date: 2023-08-31 date: 2023-08-31 date: 2024-03-26 date: 2024-04-02 name: Changye Zou class: OTHER briefSummary: Based on network pharmacology analysis, this study aims to explore the potential therapeutic targets and molecular mechanisms of puerarin on giant cell tumor of bone (GCTB) genes. conditions: Giant Cell Tumors studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 145 type: ACTUAL name: gene expression levels measure: P27 expression levels measure: ESR1 expression levels sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Churong Yan city: Guangzhou state: Guangdong zip: 518010 country: China lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06331091 id: YuzuncuYıl2022/2 briefTitle: Physiotherapy and Reaction Time in Hemophilia overallStatus: COMPLETED date: 2022-12-10 date: 2024-01-19 date: 2024-01-19 date: 2024-03-26 date: 2024-04-02 name: Yuzuncu Yıl University class: OTHER briefSummary: This randomised controlled study was conducted to investigate the comprehensive physiotherapy combined with home exercises on individuals with hemophilic arthropathy in the lower extremity. There are two groups in the study: home exercises and comprehensive physiotherapy combined with home exercises. Is physiotherapy combined with home exercises superior to home exercises on joint health, bleeding frequency, reaction time, dynamic balance, muscle strength? The aim of this study is to increase the compliance of hemophilic individuals to physiotherapy and adapt home exercises to their lives with weekly sessions. conditions: Hemophilia Arthropathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled study primaryPurpose: TREATMENT masking: NONE count: 21 type: ACTUAL name: Home exercise name: Manual therapy name: Neuromuscular electrical stimulation name: Supervised exercise measure: Hemophilia Joint Health Score measure: Reaction time sex: MALE minimumAge: 10 Years maximumAge: 32 Years stdAges: CHILD stdAges: ADULT facility: Van Yüzüncü Yıl University city: Van zip: 65080 country: Turkey lat: 38.49457 lon: 43.38323 hasResults: False

 nctId: NCT06331078 id: 29.02.2024/45 briefTitle: Square Step Exercises in Healthy Young Adults overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-02-01 date: 2025-08-01 date: 2024-03-26 date: 2024-03-29 name: Fenerbahce University class: OTHER briefSummary: This study aims to compare the effectiveness of Square Stepping Exercise and aerobic exercise on cognitive function and physical fitness in young adults. Participants aged 18-30 with low physical activity levels will be randomly assigned to either the Square Stepping Exercise Group or Aerobic Exercise Group. Both interventions will be supervised by a physiotherapist, performed twice a week for 40 minutes over 4 weeks. Cognitive function will be assessed using various tests, including attention, short-term memory, and executive function evaluations. Physical fitness will be evaluated through jump tests and balance assessments. Blinded assessors will conduct evaluations at baseline and post-intervention in both groups to determine the impact of square stepping exercise and aerobic exercise on cognitive and physical health in young adults. conditions: Exercise conditions: Square Step Exercises conditions: Aerobic Exercise conditions: Cognitive Function conditions: Physical Fitness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Square Stepping Exercise training name: Aerobic Exercise Training measure: Schulte Grid Test measure: Stroop Test measure: Verbal Fluency Test measure: Digit Span Test measure: Vertical jump test measure: Horizontal jump test measure: Y Balance Test sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Marmara University city: Maltepe country: Turkey lat: 40.93567 lon: 29.15507 hasResults: False

 nctId: NCT06331065 id: 69HCL21_1180 id: ID-RCB type: OTHER domain: 2023-A01756-39 briefTitle: Promoting Mental Health at Work Among Hospital Professionals acronym: PROMIND overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-06 date: 2024-03-26 date: 2024-03-26 name: Hospices Civils de Lyon class: OTHER briefSummary: Mental health is a state of well-being in which a person can realize his/her potential, cope with the normal stresses of life, work productively and contribute to his/her community. It refers to a continuum that extends from the promotion of well-being and the prevention of mental disorders to the treatment and rehabilitation of people suffering from these disorders.

Healthcare professionals face major mental health challenges, due to the demands of their profession, which is characterized by heavy workloads and confrontation with human distress. The frequency of mental health problems among hospital staff is high, at all stages (malaise, distress, pathologies). A meta-analysis found that caregivers suffer from around 30% anxiety, 30% depression, 30% psychotrauma and 45% sleep disorders.

According to the French Labor Code, employers are responsible for the physical and mental health of their employees. The Hospices Civils de Lyon establishment project includes a section on the prevention of psycho-social risks, quality of working life and management.

Healthcare professionals, like the general population, have high expectations of non-medication treatments. These non-medication interventions aim to prevent, treat, or cure a health problem. They are non-invasive and non-pharmacological, with certain observable impacts supported by scientific evidence.

Mindfulness meditation is one of the most extensively studied non-medication interventions in mental health. Declined in different modalities, its effects focus on improving resilience with efficacy on physical and mental well-being (stress, anxiety, burnout, affect), and their physiological corollary (cardiac and respiratory rhythms), acceptance of reality in stressful situations, reduced interpersonal conflict in emergencies and, more broadly, impact on relational behaviours (anti- and pro-social), teamwork. Managers also benefit, with a strengthening of the aspiration to lead, in a vision fully at the disposal of others.

Mindfulness meditation appears to be a practice that promotes mental well-being and could contribute to fulfilment at work.

The challenge is to offer a mindfulness meditation program in a hospital department for individual and collective benefit.

The main objective is to evaluate the evolution of psychological fulfilment in the workplace of hospital healthcare professionals in a 5-month meditation program between the baseline and the end of the program, in comparison with the evolution over the same period of a control group.

The expected outcome is to show that it is possible to implement a mindfulness meditation intervention for hospital staff in care departments, whatever their status or profession, with individual and collective benefits for mental health, psycho-social risks (stress, violence, etc.) and work organization. If it proves to be effective and acceptable, this intervention could be offered more widely within the institution and beyond. conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 120 type: ESTIMATED name: Information session on mindfulness meditation and questionnaires name: Mindfulness meditation experimentation, practice program, questionnaires, individual interview and focus group measure: Psychological fulfilment at work measure: Psychological fulfilment at work measure: Mindful state measure: Aggressiveness measure: Impulsivity, experience of being disturbed by conflict, and psychological safety. measure: Occupational stress measure: Collective activity measure: Organizational leeway measure: Evolution of participants' representation of mindfulness meditation measure: The representation of mindfulness meditation among professionals measure: The representation of mindfulness meditation among professionals measure: The representation of mindfulness meditation among professionals measure: Fidelity and adherence to the mindfulness meditation intervention measure: Fidelity and adherence to the mindfulness meditation intervention measure: Barriers and facilitators to the implementation measure: Barriers and facilitators to the implementation measure: Mechanisms of the intervention effects measure: Mechanisms of the intervention effects measure: Mechanisms of the intervention effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Neurology Department, Pierre Wertheimer Hospital (Hospices Civils de Lyon) city: Bron zip: 69677 country: France name: Sandra Vukusic role: CONTACT phone: +33 4 72 35 72 16 email: sandra.vukusic@chu-lyon.fr lat: 45.73333 lon: 4.91667 facility: Pediatric Intensive Care Unit - Continuous Monitoring, Femme Mère Enfant Hospital (Hospices Civils de Lyon) city: Bron zip: 69677 country: France name: Etienne Javouhey role: CONTACT phone: +33 4 27 85 61 56 email: etienne.javouhey@chu-lyon.fr lat: 45.73333 lon: 4.91667 facility: Department of Geriatrics, Edouard Herriot Hospital (Hospices Civils de Lyon) city: Lyon zip: 69003 country: France name: Géraldine Martin-Gaujard role: CONTACT phone: +33 4 72 11 95 31 email: geraldine.martin-gaujard@chu-lyon.fr lat: 45.74848 lon: 4.84669 facility: Neonatology and neonatal intensive care unit, Croix-Rousse Hospital (Hospices Civils de Lyon) city: Lyon zip: 69004 country: France name: Olivier Claris role: CONTACT phone: +33 4 27 85 53 48 email: olivier.claris@chu-lyon.fr lat: 45.74848 lon: 4.84669 facility: Department of Anesthesia and Intensive Care, Edouard Herriot Hospital (Hospices Civils de Lyon) city: Lyon zip: 69437 country: France name: Jullien Crozon-Clauzel role: CONTACT phone: +33 4 72 11 02 72 email: jullien.crozon-clauzel@chu-lyon.fr lat: 45.74848 lon: 4.84669 facility: Anaesthesia - Intensive Care and Perioperative Medicine Department, Lyon South Hospital (Hospices Civils de Lyon) city: Pierre-Bénite zip: 69495 country: France name: Arnaud Friggeri role: CONTACT phone: +33 4 78 86 14 76 email: arnaud.frigerri@chu-lyon.fr lat: 45.7009 lon: 4.82511 facility: Department of Physical Medicine and Neurological Rehabilitation, Henry Gabrielle Hospital (Hospices Civils de Lyon) city: Saint-Genis Laval zip: 69230 country: France name: Jacques Luauté role: CONTACT phone: +33 4 72 35 71 69 email: jacques.luaute@chu-lyon.fr lat: 45.69558 lon: 4.7934 facility: Department of Geriatrics, Charpennes Hospital (Hospices Civils de Lyon) city: Villeurbanne zip: 69100 country: France name: Clémence Grange role: CONTACT phone: +33 4 72 43 23 24 email: clemence.grange@chu-lyon.fr lat: 45.76667 lon: 4.88333 hasResults: False

 nctId: NCT06331052 id: 23-2431 id: 1R01NS125386-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01NS125386-01 briefTitle: 3-D Tractography FUS Ablation for Essential Tremor overallStatus: RECRUITING date: 2024-02-28 date: 2028-02-28 date: 2028-02-28 date: 2024-03-26 date: 2024-03-28 name: University of North Carolina, Chapel Hill class: OTHER name: Texas Tech University Health Sciences Center, El Paso name: University of Pittsburgh name: National Institute of Neurological Disorders and Stroke (NINDS) briefSummary: The investigators propose to advance Vim-FUSA (Ventral Intermediate Nucleus - Focused Ultrasound Ablation) with the support of 3-D tractography, a neuroimaging technique to visually represent nerve tracts within the brain. The investigators hypothesize that 3-D tractography Vim-FUSA will improve the Vim ablation compared to standard Vim-FUSA and prove safe and feasible in the clinical setting. The investigators also hypothesize that intraoperative magnetic resonance (i-MR) monitoring will differentiate ablated tissue from immediate perilesional edema and accurately predict the Vim-FUSA clinical outcomes. conditions: Essential Tremor studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: MR-guided Focused Ultrasound Ablation measure: Number of Participants without Side Effects measure: Absolute Change in Tremor measure: Relative Change in Tremor measure: Number of Participants with Procedure-Related Side Effects measure: Relative Change in Tremor-Related Quality of Life measure: Number of Participants Who Are Satisfied with Treatment measure: Change in Tremor Based on Video Assessment measure: Change in Gait Based on Video Assessment sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of North Carolina at Chapel Hill status: RECRUITING city: Chapel Hill state: North Carolina zip: 27999 country: United States name: Mary Ann Barnett, MLS role: CONTACT phone: 919-966-8804 email: mary-ann_barnett@med.unc.edu name: Vibhor Krishna, MD, SM role: CONTACT phone: 919-445-2410 email: vibhor_krishna@med.unc.edu name: Vibhor Krishna, MD, SM role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06331039 id: CelalBayarU-5 briefTitle: The Effects of Pelvic Floor Muscle Training and Balance Exercises in Elderly People With Incontinence overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2024-04-05 date: 2024-07-30 date: 2024-03-26 date: 2024-03-27 name: Celal Bayar University class: OTHER name: Dokuz Eylul University name: Saglik Bilimleri Universitesi briefSummary: Pelvic floor muscle weakness is one of the most important causes of incontinence. There are many studies supporting that pelvic floor muscle training prevents incontinence and reduces symptom severity, and with A level of evidence, it is among the first in the conservative treatment of incontinence. Functional status and balance problems are common in elderly people with incontinence, and it is known that functional type incontinence is common. Elderly people with incontinence most often fall while trying to get to the toilet. Balance exercises are recommended for falls and balance problems.

The aim of this study is to examine the effects of pelvic floor muscle training and balance exercises on ankle muscle function, joint range of motion and balance in individuals aged 65 and over with urinary incontinence. conditions: Urinary Incontinence conditions: Pelvic Floor Muscle Weakness conditions: Muscle Weakness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 36 type: ESTIMATED name: PFMT name: PFMT+Balance measure: ankle muscle function measure: ankle range of motion measure: muscle strength measure: incontinence symptoms and severity measure: incontinence symptoms and severity measure: balance measure: bladdery diary measure: functional performance sex: ALL minimumAge: 65 Years maximumAge: 100 Years stdAges: OLDER_ADULT facility: Melda BAŞER SEÇER city: Mani̇sa state: Yunusemre zip: 45000 country: Turkey name: Melda BAŞER SEÇER, PhD role: CONTACT phone: +905547285453 email: melda.secer@cbu.edu.tr name: Özge ÇELİKER TOSUN, Assos. Prof. role: CONTACT phone: +905055252029 email: ozge.tosun@deu.edu.tr lat: 38.61202 lon: 27.42647 hasResults: False

 nctId: NCT06331026 id: GenSci004-106 briefTitle: A Bioequivalence Study of Two Different PEG-rhGH Preparations. overallStatus: NOT_YET_RECRUITING date: 2024-04-07 date: 2024-05-31 date: 2024-11-30 date: 2024-03-26 date: 2024-03-26 name: Changchun GeneScience Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation. conditions: Pediatric Growth Hormone Deficiency (PGHD) studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 87 type: ESTIMATED name: PEG-rhGH with new preparation (T) name: PEG-rhGH with present preparation (R) measure: Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation measure: Pharmacokinetics (Area under the concentration-time curve from time zero to time infinity (AUC0-inf)) of PEG-rhGH with present and new preparation measure: Pharmacokinetics (Area under the concentration-time curve from time zero to the time of the last quantifiable (AUC0- last )) of PEG-rhGH with present and new preparation measure: Safety and tolerability（Number of participants with treatment-related adverse events） measure: Anti-drug antibody (Number of Participants with positive ADA) sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Chengdu Xinhua Hospital city: Chengdu state: Sichuan zip: 610000 country: China name: Xiaolan Yong, Doctor role: CONTACT phone: +86-28-60212136 email: yongxlan@126.com lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06331013 id: IEO 1872 briefTitle: CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr acronym: PRO-SPEED overallStatus: RECRUITING date: 2023-02-20 date: 2024-12-31 date: 2029-12-31 date: 2024-03-26 date: 2024-03-26 name: European Institute of Oncology class: OTHER briefSummary: This is a prospective observational study. The study will proceed with the enrollment of 60 patients in 2 years. he aim of the present study is to evaluate effectiveness of ultra-hypofractionated (UH) CyberKnife Stereotactic Body Radiation Therapy treatment on the whole prostate gland plus Simultaneous integrated boost (SIB) to the dominant intraprostatic lesions (DIL(s) in intermediate-unfavourable to high-risk Prostate Cancer (PCa) patients. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: CyberKnife ultra-hypofractionated SBRT measure: Number of Participants with Acute GU and GI toxicities (RTOG) measure: Number of Participants with Late GU and GI toxicities (RTOG) measure: Evaluation of patient-reported toxicity measure: Evaluation of patient-reported quality of life sex: MALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Barbara Alicja Jereczek role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06331000 id: 9248 briefTitle: Effect of One Year Elexacaftor-tezacaftor-ivacaftor Treatment acronym: DIATRIM overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-03-26 date: 2024-03-26 name: University Hospital, Strasbourg, France class: OTHER briefSummary: The development of CFTR (cystic fibrosis conductance transmembrane regulator) modulators for people with cystic fibrosis (pwCF) and eligible for these treatments is a true therapeutic revolution. The major beneficial effect of CFTR modulators (CFTRm) on pulmonary function and the reduction of pulmonary exacerbations should have a considerable impact on the quality of life and patient's life expectancy. Data on the impact of CFTRm on glucose tolerance abnormalities are still very fragmentary. The investigators can think that their use, earlier and earlier in the history of the disease, will transform the evolutionary trajectories of patients on the respiratory, nutritional and metabolic levels.

Diabetes represents a major challenge in the management of pwCF because it is a factor in morbidity and mortality at all stages of the disease, from children to patients with terminal respiratory failure requiring lung transplantation. Early abnormalities in glucose tolerance observed in childhood, before the stage of diabetes, are also associated with poor pulmonary and nutritional outcomes. Experimental data suggest a positive effect of CFTRm on insulin secretion. However, investigators do not currently know the impact of CFTRm in patients with very early glucose disorders or at the stage of diabetes treated with insulin. Recently continuous glucose measurement (CGM) devices represent very effective tools for assessing abnormalities in glucose tolerance before the stage of diabetes and for monitoring patients treated with insulin. conditions: Cystic Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: elexacaftor-tezacaftor-ivacaftor treatment measure: Evaluate time in range of blood glucose variation >140 mg/dl during 2 weeks in a cohort of adult patients treated for one year with elexacaftor-tezacaftor-ivacaftor measure: Evaluate other CGM parameters : time in range of blood glucose >180mg/dl ; >140mg/dl ; <70mg/dl ; 70-180 mg/dl ; 70-140mg/dl measure: Marker of metabolic status: HbA1c (mmol/l) measure: Marker of metabolic status: HbA1c (%) measure: Marker of metabolic status: C-Peptid (µg/L) measure: Marker of metabolic status: C-Peptid (nmol/L) measure: Markers of nutritional status: Evaluation of weight monitoring (kg) measure: Markers of nutritional status: Body Mass Index (BMI) measure: Diabetes treatment (assess insulin needs) : mean glucose value per day (mg/dl) measure: Assessment of respiratory function parameters : number of IV antibiotics measure: Number patients with severe hypoglycaemia and serious adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06330987 id: 15110_MANNELLA briefTitle: Fetal Autonomic Nervous sysTem Evaluation acronym: FANTE overallStatus: RECRUITING date: 2019-08-13 date: 2025-09-28 date: 2025-12-28 date: 2024-03-26 date: 2024-03-26 name: University of Pisa class: OTHER name: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy briefSummary: The autonomic nervous system (ANS) is involved in cardiovascular, metabolic and cognitive processes, so its study in the fetus can provide relevant functional diagnostic and prognostic information. In particular, the study of the fetal ANS allows us to understand the degree of nervous maturation reached by the fetus and any developmental disorders that could have an impact on the cardiovascular characteristics of the fetus.

The goal of this open-label, non-randomized, prospective observational study is to study the fetal ANS in pregnant women between 23 and 40 weeks of gestation.

The objetives are:

* To Evaluate Fetal Autonomic Nervous System (FANTE) through the analysis of maternal electrocardiogram (ECG) and others clinical parameters usually used in pregnancy monitoring.
* To identify any variations in the fetal ECG in the event of developmental or pathological maternal and/or fetal pregnancy.

Participants will be recruited during ultrasound visits, information sessions, and hospitalizations after signing informed consent. conditions: Pregnancy Related conditions: Pregnancy Disease conditions: Pregnancy Complications conditions: Pre-Eclampsia conditions: Gestational Diabetes conditions: ECG Electrode Site Reaction conditions: Fetal Growth Retardation conditions: Fetal Complications studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 186 type: ESTIMATED name: electrocardiograph measure: Fetal Autonomic Nervous sysTem Evaluation (FANTE) measure: Maternal Assesment measure: Obstetric Complications and mode of Delivery sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliera Universitaria Pisana status: RECRUITING city: Pisa zip: 56126 country: Italy name: Paolo Mannella, MD. PhD. role: CONTACT phone: 0039.050.993523 email: paolo.mannella@unipi.it lat: 43.70853 lon: 10.4036 hasResults: False

 nctId: NCT06330974 id: FinnATOPY briefTitle: Allergy, Asthma, and Atopic Eczema in Finland acronym: FinnATOPY overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2032-12 date: 2034-12 date: 2024-03-26 date: 2024-03-26 name: Tampere University class: OTHER name: Professor Lauri Lehtimäki name: Professor Mika Mäkelä name: Professor Sanna Toppila-Salmi name: Professor Ilkka Junttila briefSummary: The summary is available at --\> https://www.finnatopy.fi/summary conditions: Asthma conditions: Asthma in Children conditions: Allergy conditions: Rhinitis, Allergic conditions: Atopic Dermatitis conditions: Allergen Immunotherapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 2000000 type: ESTIMATED name: No intervention measure: Epidemiology of atopic diseases and allergic sensitization profiles in Finland measure: Burden of atopic diseases (allergies, asthma, and atopic eczema) as well as comorbidities in Finland measure: Evaluate and improve the current use of diagnostic tests for atopic diseases measure: Use and effectiveness of allergen immunotherapy in real world setting measure: Direct and indirect costs related to atopic diseases and comorbidities sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Tampere University city: Tampere country: Finland lat: 61.49911 lon: 23.78712 hasResults: False

 nctId: NCT06330961 id: 2023-MED-2756299 briefTitle: Effects of Different Kinds of Exercise in Low Back Pain overallStatus: RECRUITING date: 2024-01-08 date: 2024-06 date: 2025-02 date: 2024-03-26 date: 2024-03-26 name: University of Valencia class: OTHER briefSummary: Low back pain is considered one of the great global challenges in public health due to its high prevalence. Exercise have been shown to cause an increase in pain thresholds, through the effect known as exercise-induced hypoalgesia. Little is known about exercise-induced hypoalgesia induced by different modalities of exercise in low back pain, and its possible effects in lumbopelvic biomechanics.

The goal of this clinical trial is to compare the effect of exercise-induced hypoalgesia after an isometric, aerobic and a sham/ placebo exercise in non-specific low back pain. The main questions it aims to answer are:

* Does an isometric exercise intervention cause exercise-induced hypoalgesia in non-specific low back pain patients?
* Is the effect of an isometric exercise intervention comparable to that of aerobic exercise?
* Is a placebo/ sham intervention also effective to reduce pain thresholds in these patients?
* Do healthy subjects show the same effects in pain thresholds as low back pain patients ? Participants will perform an isometric, aerobic and placebo/ sham exercise intervention in three different recording sessions. Before and after the interventions, pain intensity, pain-pressure thresholds and lumbopelvic biomechanical parameters during trunk flexion-extension will be recorded.

Researchers will compare a group of low back pain patients to an age-, gender- and anthropometrics-matched control group of pain-free subjects to see if exercise-induced hypoalgesia is also observed when there is no low back pain diagnosis. conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: Isometric exercise name: Aerobic exercise name: Placebo intervention measure: Pain intensity measure: Pain-pressure thresholds measure: Trunk flexion-extension electromyography (EMG) measure: Flexion-extension ratio (EMG) measure: Maximum ranges of lumbar and pelvic flexion measure: Trunk flexion-extension percentages of motion measure: Time of maximum flexion measure: Fear-avoidance beliefs measure: Pain distribution and supra-threshold stimulation measure: Anthropometric data: height measure: Anthropometric data: weight measure: Date of birth/ age measure: Sex/ gender measure: Basic clinical history and occupational data sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Clinical Anatomy of the Musculoskeletal System Laboratory. Department of Anatomy and Human Embryology, School of Medicine, Universitat de València status: RECRUITING city: Valencia zip: 46010 country: Spain name: Daniel Sánchez-Zuriaga, PhD, MD role: CONTACT phone: +343983522 phoneExt: 83522 email: daniel.sanchez@uv.es lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06330948 id: NYCU112183AEF briefTitle: Effects of SugarCut® Unripe Guava Fruit Extract on Blood Glucose Regulation overallStatus: RECRUITING date: 2024-04 date: 2025-01 date: 2025-01 date: 2024-03-26 date: 2024-04-15 name: National Yang Ming University class: OTHER briefSummary: Guava (Psidium guajava) belongs to the Myrtle family. It is a tropical and subtropical fruit native to the Americas. Ripe guava fruit is sweet and delicious. It is rich in vitamins A, C and trace elements such as phosphorus, calcium and magnesium. In traditional medicine, guava fruit can be eaten raw, and the roots can treat stomach problems, abdominal pain, dysentery, and diabetes; the leaves can treat diabetes, abdominal pain, rheumatism, antipyretic, stomachache, anthelmintic, cholera, vomiting, diarrhea, enteritis and other symptoms. Guava leaf extract contains polyphenols. Studies have shown that guava leaf has antioxidant, blood sugar regulating and anti-cancer effects. Not only guava leaves, research has found that guava fruits are rich in vitamins, fiber and antioxidants, which have anti-inflammatory and anti-cancer effects. Preliminary research has found that the extract of red guava young fruit has more active ingredients - saponins and total polyphenol content, and its antioxidant capacity is also higher than that of mature guava. In vitro studies have found that guava fruit extract can increase the expression of GLUT4 gene and promote the entry of blood sugar into cells. At the same time, guava fruit extract can inhibit the formation of final glycated proteins (AGEs). The purpose of this study is to explore the effect of guava fruit extract on blood sugar regulation in humans and to evaluate its potential to be developed as a blood sugar regulation supplement. conditions: PreDiabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: SugarCut® Unripe Guava Fruit Extract name: Placebo group measure: GLUT4 gene expression measure: Hematology Test sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: National Yang Ming Chiao Tung University status: RECRUITING city: Taipei state: Beitou Dist. zip: 112 country: Taiwan name: Tze-Fang Wang, Ph.D. role: CONTACT phone: +886-2-28267907 email: tzefang@nycu.edu.tw lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06330935 id: 192-2023 briefTitle: Evaluating the Effect of Tranexamic Acid on the Clinical Outcomes in Patients With Traumatic Brain Injury overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-03-26 date: 2024-03-26 name: Mansoura University class: OTHER briefSummary: Evaluate the effect of tranexamic acid on mortality in pediatric patients with traumatic brain injury. This could potentially lead to improved treatment protocols and better outcomes for this vulnerable population. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: Tranexamic Acid (TXA) name: Normal saline measure: The early traumatic brain injury-related death in the hospital measure: The difference between treatment group in the Intracranial haemorrhage growth measure: The difference between the treatment groups in the incidence of mortality measure: Need for neurosurgical management measure: Days in the intensive care unit measure: Need for blood transfusion measure: Adverse events measure: Pediatric Quality of Life (PedsQL) measure: Pediatric Glasgow Outcome Scale Extended (GOS-E) Peds) sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06330922 id: 10.55776/V992 briefTitle: Muscle-tendon Pathology and Metabolic Dysregulation in CP overallStatus: RECRUITING date: 2024-03-08 date: 2025-12-31 date: 2025-12-31 date: 2024-03-26 date: 2024-03-26 name: University of Graz class: OTHER name: Medical University of Graz name: Karolinska Institutet briefSummary: The main aim of this project is to gain knowledge about the muscle-tendon pathology of moderately to severely affected young people with cerebral palsy and their risk for cardiometabolic diseases and chronic inflammation. Furthermore, it will be investigated whether there are associations between the existing pathophysiology as well as inactivity and muscle function, cardiometabolic risk factors and inflammation. Moreover, the potential of the target group for adaptation of its muscular, cardiorespiratory, and endocrine system will be investigated.

The study parameters will be determined in adolescents and young adults aged 14 to 25 years with moderate to severe spastic cerebral palsy and compared with those of their less severely affected and healthy peers (cross-sectional study). In addition, the more affected individuals will participate in a 12-week training intervention (longitudinal study) performed with special tricycles (i.e., Frame Runners).

To measure the study parameters, ultrasound, strength tests, near-infrared spectroscopy, blood analyses, and spiroergometry will be used. The fitness training will be performed two times a week for 12 weeks with the Frame Runners. conditions: Cerebral Palsy, Spastic studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: Cardiorespiratory fitness training measure: Muscle fascicle length and muscle thickness measure: Muscle fascicle pennation angle measure: Passive muscle stiffness measure: Isometric muscle strength measure: Muscle tissue oxygenation measure: Exosome size measure: Exosome content measure: Micro ribonucleic acid (RNA) cargo measure: Metabolic parameters measure: Pro-inflammatory cytokines measure: Resting, mean, and peak heart rate measure: Resting blood pressure measure: Distance covered measure: Peak oxygen uptake (VO2peak), Peak ventilation (VEpeak) measure: Peak respiratory frequency measure: Respiratory exchange ratio measure: VEpeak/VO2peak measure: VEpeak/VCO2peak measure: Perceived exertion measure: Well-being and quality of life measure: Total physical activity, time spent in different intensities measure: Passive range of motion (sagittal plane) of hip, knees, ankles measure: Step count measure: Body height measure: Body weight measure: Body mass index (BMI) measure: Modified Ashworth Scale Score of the Plantar flexors sex: ALL minimumAge: 14 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Institute of Human Movement Science, Sport and Health, University of Graz status: RECRUITING city: Graz zip: 8010 country: Austria name: Sebastian Ruin, Univ.-Prof. role: CONTACT phone: 00433163802336 email: sebastian.ruin@uni-graz.at lat: 47.06667 lon: 15.45 hasResults: False

 nctId: NCT06330909 id: P003103 id: DRKS00022915 type: OTHER domain: Deutsches Register Klinische Studien briefTitle: Image-guided Focal Dose Escalation- Primary pc Treated With Primary External Beam Hypofract.Stereotactic rt acronym: HypoF-SBRT overallStatus: RECRUITING date: 2022-08-18 date: 2025-08 date: 2030-02 date: 2024-03-26 date: 2024-03-26 name: University Hospital Freiburg class: OTHER name: German Federal Ministry of Education and Research briefSummary: Technical advances in radiotherapy (RT) treatment planning and delivery have substantially changed RT concepts for primary prostate cancer (PCa) by (i) enabling a reduction of treatment time and by (ii) enabling a safe delivery of high RT doses. Several studies proposed a dose-response relationship for patients with primary prostate cancer (PCa) and especially in patients with high-risk features a dose escalation should lead to improved tumor control. In parallel to the improvements in RT techniques, diagnostic imaging techniques like multiparametric magnetic resonance imaging (mpMRI) and positron-emission tomography (PET) evolved and enable an accurate depiction of the intraprostatic tumor mass for the first time. The HypoFocal-SBRT study combines ultra-hypofractionated RT / stereotactic body RT (reduction of treatment time) with a focal RT dose escalation on intraprostatic tumor sides by applying state of the art diagnostic imaging and most modern RT concepts. This novel concept will be compared with moderate hypofractionated RT (MHRT), one option for the curative primary treatment of PCa, which has been proven by several prospective trials and is recommended and carried out worldwide. We suspect an increase in relapse-free survival (RFS) and we will also assess quality of life in order to detect potential changes. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective, randomized two arm phase III multicentre trial comparing image-guided focal dose escalation using SBRT in patients with primary PCa treated with primary external beam hypofractionated radiation therapy.

Patients will be randomized to either arm A (experimental intervention) or arm B (control intervention). primaryPurpose: TREATMENT masking: NONE count: 374 type: ESTIMATED name: Radiotherapy (RT) Arm A - IMRT/IGRT/SBRT name: Radiotherapy (RT) Arm B - IMRT/IGRT measure: Relapse free survival measure: Time to local failure after randomization measure: Metastatic free survival after randomization measure: Overall (OS) and prostate cancer specific (PCSS) survival after randomization measure: Time to biochemical failure (phoenix definition) after randomization measure: Patient reported acute quality of life (QOL) - Expanded Prostate Index Composite-26 (EPIC-26) measure: Patient reported late quality of life (QOL) measure: Cumulative acute GU and GI toxicities during and up to 3 months after RT using the CTCAEv5.0 criteria measure: Cumulative Chronic GU and GI toxicities after RT using the CTCAEv5.0 criteria measure: Dose constraints and prescription doses / recruited patients measure: Characterization of safety: adverse events sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Center - University of Freiburg status: RECRUITING city: Freiburg state: Baden-Württemberg zip: 79106 country: Germany lat: 47.9959 lon: 7.85222 hasResults: False

 nctId: NCT06330896 id: 346/2566(IRB3) briefTitle: Disease Characteristics and Treatment Response in Plasma Cell Disorders Patients Based on Genetic Abnormalities From Fluorescence In Situ Hybridization and Next Generation Sequencing acronym: genetics MM overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-09-30 date: 2028-04-01 date: 2024-03-26 date: 2024-03-26 name: Siriraj Hospital class: OTHER briefSummary: The goal of this observational study is to study the genetic landscape in patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis in Thailand. The main questions it aims to answer are:

* genetic landscape in patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis in Thailand who were performed FISH and/or NGS testing
* genetic correlation and genetic dependency between FISH and NGS, stratified by high- and standard-risk groups based on FISH testing in Thai MM patients.
* disease characteristics and response rates in MM patients with cytogenetic abnormalities detected by FISH and/or genetic mutations detected by NGS.
* correlation between cytogenetic abnormalities identified by FISH and genetic mutations detected by NGS with progression-free survival in MM patients.

The FISH and/or NGS testing results, disease characteristics, treatment, and treatment outcomes of patients with plasma cell disorders who underwent FISH and/or NGS testing before IRB approval will be collected through retrospective chart review. Subsequently, data will be gathered prospectively. Participants will provide approximately 12 mL of bone marrow fluid for FISH and NGS testing. conditions: Plasma Cell Disorder studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 498 type: ESTIMATED measure: genetic landscape of PCD measure: genetic correlation measure: genetic landscape of relapse MM patients measure: overall survival measure: progression free survival measure: factor of genetic landscape differentiation measure: gender measure: age sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06330883 id: 2021/507 briefTitle: Determining the Prevalence of Frailty and Evaluating Its Relationship With Mortality. overallStatus: COMPLETED date: 2022-01-01 date: 2023-01-01 date: 2023-01-01 date: 2024-03-26 date: 2024-03-26 name: Selcuk University class: OTHER briefSummary: Covid-19 patients admitted to the intensive care unit of Selcuk University Hospital were included in the study. Clinical frailty score was given during admission to the intensive care unit. Demographic data, laboratory data, radiological imaging and vital signs of the patients were recorded. Treatment and patient positions were recorded during the intensive care follow-up of the patients. Mortality status of the patients 6 months after admission to the ICU was recorded. conditions: Frailty conditions: Mortality conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 148 type: ACTUAL name: Prognosis measure: Mortality measure: The Sequential Organ Failure Assessment Score, The Acute Physiology and Chronic Health Evaluation II Score measure: Thorax computed tomography (CT) imaging measure: Laboratory values measure: Respiratory support measure: Vasoactive drugs administered measure: Renal replacement therapy measure: Patient positions measure: Length of stay in the intensive care unit sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Selcuk University Hospital city: Konya state: Selçuklu country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06330870 id: BCBM_Breast briefTitle: Brain Metastasis Development Mechanism in BCBM Patients overallStatus: RECRUITING date: 2023-04-06 date: 2025-02-05 date: 2027-12-31 date: 2024-03-26 date: 2024-03-26 name: Samsung Medical Center class: OTHER briefSummary: This study is the experimental study for brain metastasis development mechanism in patients with breast cancer with brain metastasis conditions: Breast Cancer conditions: Brain Metastasis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 30 type: ESTIMATED name: WGS/TME evaluation measure: Intracranial disease free survival sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ji-Yeon Kim status: RECRUITING city: Seoul zip: 06351 country: Korea, Republic of name: Ji-Yeon Kim role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06330857 id: Dnr2021-06921-02 briefTitle: Recurrence and Bowel Function After Laparoscopic Vaginorectopexy, a Modified Anterior Rectopexy overallStatus: ACTIVE_NOT_RECRUITING date: 2002-05-28 date: 2024-04-01 date: 2025-04-01 date: 2024-03-26 date: 2024-04-17 name: Sahlgrenska University Hospital, Sweden class: OTHER briefSummary: Several pelvic prolapses can render defecation difficulties and they are often treated with different surgical techniques. This study will evaluate a novel variation of a laparoscopic technique used to treat rectal prolapse that is modified to treat multiple pelvic prolapses. 25 women with symptoms of obstructed defecation and multiple pelvic prolapses are assessed before and after surgery with clinical examination, defecography and a questionnaire for bowel function and quality of life. Follow up was scheduled after three and twelve months and at long term (minimum ten years). conditions: Rectal Prolapse conditions: Fecal Incontinence conditions: Defecation Disorder conditions: Enterocele conditions: Rectocele studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Evaluation of recurrence with clinical examination and defecography. Evaluation of bowel function with a questionnaire. primaryPurpose: TREATMENT masking: NONE count: 25 type: ACTUAL name: Laparoscopic vaginorectopexy measure: Recurrence measure: Bowel function measure: Bowel related quality of life measure: Postoperative complications measure: Peroperative complications measure: Operative time measure: Conversions to open surgery measure: Hospital days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06330844 id: RBSEF-MCI-CCT briefTitle: Race-Based Stress and Cognitive Training for MCI overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2026-09-15 date: 2027-03-15 date: 2024-03-26 date: 2024-03-26 name: Rosalind Franklin University of Medicine and Science class: OTHER briefSummary: This a two phase project that aims to pilot a new adaptation (Phase 1) of Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT; an originally VA-based cognitive rehabilitation manualized intervention for older adults with MCI, with a focus on the impact of stress on cognitive functioning; that integrates components from the Race Based Stress and Empowerment (RBSE) group for an increased focus on race-based stress and discrimination for racial minority older adults (i.e., RBSEF-CCT-MCI). In a pilot open trial, 75-150 participants will receive group-based intervention for 8 weeks, with 8-10 participants per group.

Following the pilot study, the investigators will complete a randomized controlled trial (RCT) (Phase 2) to compare the efficacy of the RBSEF-CCT-MCI with the ME-CCT. In the RCT, 75-150 participants will be randomized into either 1) The active control group, who will complete the original, ME-CCT training program, or 2) The experimental group, who will complete the newly developed RBSE-CCT-MCI. Both research groups will complete the interventions for 8 weeks, with 8-10 participants per group.

Hypothesis: Participation in this newly developed/updated intervention (i.e., RBSEF-CCT-MCI) will result in improvements in both (a) subjective and (b) objective cognitive functioning, and (c) self-reported mental health symptoms. conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups assignment - One group will complete the original ME-CCT training program. The other group will complete the newly developed RBSE-CCT-MCI. primaryPurpose: TREATMENT masking: NONE count: 9 type: ESTIMATED name: Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment (RBSEF-CCT-MCI) name: Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT) measure: Verbal learning and memory measure: Basic auditory attention and working memory measure: Psychomotor processing speed measure: Psychomotor processing speed; executive functioning measure: Self-report of prospective and retrospective memory measure: Self-report of cognitive concerns measure: The Patient Health Questionnaire-9 measure: Self-report symptoms of anxiety measure: Self-reported daily functioning measure: The Racial Microaggressions Scale measure: The Trauma Symptoms of Discrimination Scale sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Rosalind Franklin University of Medicine and Science city: Chicago state: Illinois zip: 60064 country: United States name: Rachael Ellison, PhD role: CONTACT name: Rachael Ellison, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06330831 id: x2ghr8pc briefTitle: Intensive Group Based CIMT for Young Children overallStatus: COMPLETED date: 2016-05-09 date: 2023-06-28 date: 2023-07-01 date: 2024-03-26 date: 2024-03-26 name: Rockhurst University class: OTHER name: Ability KC briefSummary: This project aims to investigate the effectiveness of an intensive, group-based Constraint Induced Movement Therapy (CIMT) program for young children ages 2-6 years with unilateral hemiparesis, or weakness on one side of the body. This project involves two studies. Study 1 investigates the effect of one dosage of a 1-month, intensive group based CIMT summer program. Study 2 investigates the effect of a repeated, consecutive episode of the intensive, group based CIMT program for children who attended the program the following summer. conditions: Hemiplegic Cerebral Palsy conditions: Non-Accidental Traumatic Head Injury to Child studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Study 1 is a single group pre-post study of children who received 1 episode of the intensive, group based CIMT intervention (2 data points- pre CIMT 1 and post CIMT1). Study 2 is a repeated measures design to evaluate the long-term effects of the first episode and the effects of the second episode of intensive group based CIMT (4 data points- pre CIMT1; post CIMT1 (at the end of 1 month intervention); pre CIMT 2- 11 months after post of CIMT1; post CIMT 2- 12 months post CIMT 1) primaryPurpose: TREATMENT masking: NONE maskingDescription: No masking occurred for the participants or care providers since all parents/caregivers consented to have their children participate in the intensive group based CIMT intervention. The parents/ care providers knew who the interventionists were. The principal investigator was aware of all participants' assignment to the study. The principal investigator also delivered the intervention to the 2-3-year-old group and also served as the assessor of outcomes along with trained student investigators. The principal investigator attempted to limit bias by having all students achieve an inter-rater reliability level of 90% or above (intra-class correlation coefficient ICC\>.90) on the QUEST and by not allowing the student investigators or herself to consult the pre-intervention assessment outcome scores until after post-intervention outcome assessment scoring was completed. count: 35 type: ACTUAL name: Intensive, Group Based Constraint Induced Therapy (CIMT) measure: Quality Upper Extremity Skills Evaluation Test (QUEST) measure: Assisting Hand Assessment (AHA) measure: Canadian Occupational Performance Measure (COPM) measure: Pediatric Evaluation Disability Inventory (PEDI) sex: ALL minimumAge: 20 Months maximumAge: 6 Years stdAges: CHILD hasResults: False

 nctId: NCT06330818 id: IMAGINE Moyamoya id: 528291394 type: OTHER_GRANT domain: German Research Council (DFG) briefTitle: Imaging in Moyamoya Disease - Study to Investigate Different Imaging Technologies for a Better Understanding of Various Imaging Techniques to Evaluate Cerebral Hemodynamics, Disease-activity and Possibly the Etiology in Moyamoya Patients acronym: IMAGINE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-30 date: 2027-05-30 date: 2024-03-26 date: 2024-03-26 name: University Hospital Tuebingen class: OTHER name: University Hospital Freiburg briefSummary: Aim of this study is to improve patient care in Moyamoya Patients by improving Imaging technologies and aiming to identify factors involved in disease progression.

Main tasks are:

* Analysis of CO2-triggered BOLD fMRI for analysis of cerebral hemodynamics in comparison to H2 15O PET/CT
* Analysis of longitudinal changes of contrast enhancement in vessel-wall imaging and correlation of disease activity with biosampling
* Definition of a standardized recommendation for pre- and postoperative imaging of Moyamoya patients conditions: Moyamoya Disease conditions: Moyamoya studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: MRI name: H2 15O PET/CT name: Biosampling measure: Value of CO2-triggered BOLD MRI compared to PET/CT measure: Vessel-Wall contrast enhancement measure: Circulating endothelial cells measure: PCR-based virus sampling sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06330805 id: OSU-23069 id: NCI-2024-00705 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) briefTitle: Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-12-31 date: 2027-12-31 date: 2024-03-26 date: 2024-03-26 name: Ohio State University Comprehensive Cancer Center class: OTHER name: Pfizer name: Myovant Sciences GmbH name: Sumitomo Pharmaceuticals America briefSummary: This phase II trial compares the effect of relugolix to leuprolide on cardiac function and performance in patients with prostate cancer. Androgen deprivation therapy (ADT) has been a key component for the treatment of advanced prostate cancer for decades. The term androgen deprivation therapy means lowering a man's testosterone. Long-term studies show that ADT may contribute to a detriment to cardiac health and predisposes men to developing cardiac diseases. Recent studies suggest that men taking relugolix for treatment of prostate cancer may have a lower risk of developing cardiovascular problems, but more studies are needed to understand this observation, and there are currently no studies reporting the direct impact of ADT (relugolix, versus the more-commonly used leuprolide) on cardiac function and outcomes.

Participants will receive definitive radiotherapy for unfavorable intermediate risk prostate cancer and 6-month ADT (either relugolix or leuprolide). In addition, participants will undergo the following:

1. Comprehensive cardiac and exercise testing before and after starting ADT
2. Completion of quality-of-life questionnaires at specific intervals during the study period
3. Provide blood samples at specific intervals during the study period to test for changes in steroid levels and certain biomarkers conditions: Prostate Adenocarcinoma conditions: Stage IIB Prostate Cancer AJCC v8 conditions: Stage IIC Prostate Cancer AJCC v8 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: Biospecimen Collection name: Contrast Agent name: Leuprolide name: Magnetic Resonance Imaging name: Physical Performance Testing name: Relugolix measure: Physiologic alterations in cardiopulmonary function - Myocardial perfusion measure: Physiologic alterations in cardiopulmonary function - Maximal rate of oxygen consumption measure: Quality of life using EPIC-26 measure: Quality of life using EORTC QLQ-C30 measure: Quality of life using European (Euro) Qol-5-Dimension 5-level (EQ-5D-5L) measure: Quality of life using PROMIS measure: Functional tests of strength and balance using Timed Up-and-Go measure: Functional tests of strength and balance using 10-meter walk time measure: Functional tests of strength and balance using Grip strength measure: Changes in body composition sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio State University Comprehensive Cancer Center city: Columbus state: Ohio zip: 43210 country: United States name: Shang-Jui Wang role: CONTACT phone: 614-366-9306 email: Shang-Jui.Wang@osumc.edu name: Shang-Jui Wang role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06330792 id: mechanical low back pain briefTitle: Effect of Bio-mechanical Awareness and Core Stability Exercises on Mechanical Low Back Pain overallStatus: NOT_YET_RECRUITING date: 2024-05-04 date: 2024-08-01 date: 2024-12-01 date: 2024-03-26 date: 2024-04-25 name: Cairo University class: OTHER briefSummary: investigate the effect of bio-mechanical awareness and core stability exercises on mechanical low back pain among Egyptian Physiotherapists conditions: Mechanical Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Physiotherapists will be randomly subdivided into two equal groups in number. Group (A) (Experimental Group): This group will receive biomechanical awareness advices while working and core stability exercises.

Group (B) (Control Group): This group will receive core stability exercises only. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 66 type: ESTIMATED name: bio-mechanical awareness name: core stability exercises measure: intensity of low back pain measure: back muscle endurance measure: level of function (disability) associated with mechanical Low Back Pain measure: Fatigue Severity measure: psycho-social factors at work sex: ALL minimumAge: 25 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06330779 id: UWest briefTitle: Trauma-adapted Yoga in Child & Adolescent Psychiatry. acronym: TAY-CAP overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2027-12-31 date: 2028-12-31 date: 2024-03-26 date: 2024-03-26 name: University West, Sweden class: OTHER name: Västra Götalands Region name: Region Stockholm name: Region Skåne name: Region Värmland name: Region Östra Gotland name: Region Örebro briefSummary: The goal of this randomized clinical trial is to evaluate the efficacy of trauma-adapted yoga as a complementary intervention to care as usual in child and adolescents psychiatry clinics, in the population of adolescents with the diagnosis of ADHD and/or PTSD. We hypothesize that trauma-adapted yoga (TAY) is an effective non-pharmacological intervention for adolescent with ADHD and/or PTSD. Aims: (1) Validate the impact of TAY on the mental health \& quality of life of adolescents with ADHD and/or PTSD. (2) Investigate the feasibility of online TAY for continued self-care. (3) Explore adolescents' experiences \& parental perspectives on TAY in their treatment. (4) Explore healthcare professionals' experience on the integration of TAY into clinical practice.

Within and between group (yoga group vs waiting list) analyses will be performed. conditions: ADHD conditions: PTSD conditions: Quality of Life conditions: Self-Control conditions: Pain conditions: Affect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 180 type: ESTIMATED name: Trauma-adapted yoga measure: Negative experience score CPSS-5-S measure: Inattention, impulsivity score measure: Resilience score measure: Pain frequency and intensity measure: affect measure: Self-directednes measure: Quality of life score sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06330766 id: PET24 briefTitle: Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Transcatheter Aortic Valve Implantation Patients acronym: DENTAVI overallStatus: RECRUITING date: 2020-01-01 date: 2026-01-01 date: 2026-01-01 date: 2024-03-26 date: 2024-03-26 name: Odense University Hospital class: OTHER briefSummary: In Odense University Hospital preoperative dental screening (PDS) protocol for patients treated with Transcatheter Aortic Valve Implantation (TAVI) was changed from mandatory to targeted PDS to between June 2023 to october 2023. The investigators will therefore compare the risk of IE before june 2023 and after october 2023. conditions: Transcatheter Aortic Valve Implantation conditions: Dental conditions: Endocarditis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: No preoperative dental screening measure: Number of Participants with Infectious Endocarditis measure: Number of Participants undergoing Oral surgical procedure at dental screening measure: Number of Participants undergoing Tooth extraction at dental screening measure: The different Bacteria types causing the infectious endocarditis assessed by blood culture measure: Number patients with Bacteremia assessed by positive blood culture measure: Number of Participants with IE caused by bacteria from oral foci measure: Number of Participants with Cardiac implantable electronic device risk of IE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Odense University Hospital, Cardiology Department status: RECRUITING city: Odense zip: 5000 country: Denmark name: Jordi S Dahl, MD,PhD,DMSc role: CONTACT phone: 004524638899 email: Jordi.Sanchez.Dahl@rsyd.dk name: Lytfi Krasniqi, MD role: CONTACT phone: 004524638899 email: Lytfi.Krasniqi@rsyd.dk name: Jordi S Dahl, MD,PhD,DMSc role: PRINCIPAL_INVESTIGATOR name: Lytfi Krasniqi, MD role: PRINCIPAL_INVESTIGATOR lat: 55.39594 lon: 10.38831 hasResults: False

 nctId: NCT06330753 id: 2024P000682 briefTitle: Synergy Between Patient and Clinician: Using a Trauma-Informed Care Plan acronym: TICP overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-05-15 date: 2025-11-30 date: 2024-03-26 date: 2024-03-26 name: Brigham and Women's Hospital class: OTHER briefSummary: The goal of this prospective study is to test the: acceptability of trauma-informed care plans; the intervention appropriateness; and the feasibility of the trauma-informed care plans in the electronic health care record. Patient seen in various health care settings and how have complex health care needs will be invited to participate in this study. The aims to are:

Aim 1: Explore the acceptability of trauma-informed care plans, the appropriateness of trauma-informed care plans, and the feasibility of Trauma-Informed Care Plans(TICP) when used by clinicians on the health care team (HCTC). Hypothesis 1: HCTC using the TICP will report its acceptability, feasibility, satisfaction and ease of use. Hypothesis 2: HCTC will report heightened awareness of intersection of trauma and social determinants of health. Hypothesis 3: HCTC will report more awareness of the patient's unique preferences and will be better informed regarding the unique plan of care for their patient.

Aim 2: Explore the impact of having a TICP by patients understanding how the TICP may have improved their experience around care and treatment. Hypothesis 1: patients will report: improved satisfaction with their care. Hypothesis 2: patients will report feeling better known by HCT. Hypothesis 3: will report less stress and anxiety related to health care encounters. conditions: Trauma and Stressor Related Disorders conditions: Violence, Structural conditions: Violence, Domestic conditions: Violence, Sexual studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a prospective study designed to explore the acceptability, intervention appropriateness of trauma-informed care plans and the feasibility of trauma-informed care plans by patients and members of the health care team primaryPurpose: TREATMENT masking: NONE maskingDescription: Participants (patients and providers) will be de-identified count: 200 type: ESTIMATED name: Trauma-informed Care Plan- measure: Acceptability of Trauma Informed Care Plans measure: Intervention Appropriateness of Trauma-Informed Care plans measure: Feasibility of the trauma-informed care plans sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06330740 id: AAAU3416 briefTitle: Evaluations of CDS Systems overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-09 date: 2025-12 date: 2024-03-26 date: 2024-03-26 name: New York Presbyterian Hospital class: OTHER briefSummary: Indications-based prescribing is a medication ordering system in which a clinician selects an indication, and then the electronic health record (EHR) suggests an appropriate medication regimen. This approach was shown to significantly decrease medication ordering errors in a prototype environment. However, the effect of indications-based prescribing on preventing ordering errors has not been rigorously evaluated in a real-world healthcare setting. Antibiotics are the medication class most likely to contain ordering errors, which can lead to significant patient harm. At NewYork-Presbyterian (NYP) a robust antimicrobial indication-based order set was developed to help clinicians identify the appropriate antibiotic, dose, frequency, and duration, based on type of infection and patient-specific characteristics, but it is not widely used. The investigators propose a randomized controlled trial to assess the effectiveness of this indications-based order set for reducing antimicrobial ordering errors. conditions: Safety Issues studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 2000 type: ESTIMATED name: Clinical Decision Support measure: The combined rate of Wrong Drug, Wrong Duration, Wrong Dose and Wrong Frequency Retract-And-Reorder (RAR) events will be combined to create an overall rate of near-miss ordering errors in the control and intervention arm. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06330727 id: KY20231109-09 briefTitle: Effects of Coffee Consumption on Metabolic Markers in Adults With Prediabetes and Obesity overallStatus: RECRUITING date: 2024-02-05 date: 2024-10 date: 2024-10 date: 2024-03-26 date: 2024-03-26 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: Epidemiological studies have shown an inverse association between coffee consumption and risk of type 2 diabetes. However, the randomized controlled trials in prediabetes are limited to evaluate the effects of coffee. The purpose of this study is to investigate the effects of coffee on metabolic factors and inflammation in individuals with prediabetes and obesity. A double-blind, randomized controlled trial is designed to explore the effects of coffee consumption on participants with prediabetes and obesity. A total of 100 eligible participants with prediabetes and obesity will be recruited from the Health Management Center of Nanjing First Hospital. These participants are randomly assigned in a 1:1 ratio to either the coffee capsule group or the control group. The coffee capsule group will be instructed to consume 3.6 g of coffee capsules per day (0.3 g per capsule, 6 capsules per serving, twice a day, once in the morning and once in the middle of the day). The control group will be asked to consume 3.6 g of cornstarch capsules (0.3 g per capsule, 6 capsules per serving, twice a day, once in the morning and once in the middle of the day). 75 g oral glucose tolerance test, 2-week blinded continuous glucose measurement and others will be performed before and after the 3-month intervention. During the three months of intervention, the information on dietary intake, physical activity and sleep of participants will be systematically collected. To comprehensively assess the impact of coffee intake on prediabetes and obesity, we will analyze the effects of coffee capsules on various metabolic and inflammatory markers, including glucose metabolism, lipid profiles, blood pressure, adiponectin, high sensitivity C-reactive protein, interleukin-6, body mass index, body composition, the degree of hepatic steatosis and so on. We will further adjust for potential confounding factors such as lifestyle factors to better understand the underlying biological mechanisms driving this association. conditions: Prediabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: Coffee capsule name: Corn starch capsule measure: Continuous glucose monitoring parameters measure: glucose from a 75 g-oral glucose tolerance test （mmol/L） measure: insulin from a 75 g-oral glucose tolerance test （pmol/L） measure: C-peptide from a 75 g-oral glucose tolerance test (ng/ml) measure: glucagon from a 75 g-oral glucose tolerance test（pmol/L） measure: Glycated hemoglobin (HbA1c) ( % ) measure: Fasting total cholesterol (mmol/L) measure: Fasting high-density lipoprotein-cholesterol (mmol/L) measure: Fasting low-density lipoprotein-cholesterol (mmol/L) measure: Fasting triglycerides (mmol/L) measure: C-reactive protein measure: Interleukin-6 measure: Body mass index ( kg/m^2) measure: Fat mass (FM) measure: body fat percentage (BF) measure: visceral fat measure: skeletal muscle mass (SMM) measure: fat-free mass (FFM) measure: Adiponectin measure: Systolic blood pressure（mmHg） measure: Diastolic blood pressure（mmHg） measure: Heart rate （bpm） measure: Controlled attenuation parameter (CAP) measure: Standard deviation of heart rate variability (SDNN) sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: Nanjing First Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210006 country: China name: Jun Wang, M.D., PhD. role: CONTACT phone: 8613382079966 email: wangjun868@163.com name: Lin Li, PhD. role: CONTACT phone: 8615380998768 email: guobaolimu@126.com lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06330714 id: AV.RMH.v01-01 briefTitle: Remote Monitoring of Chronic Illness Patients With a IHAP Home Wireless Hub and Vitals Measurements acronym: REMOTE-HUB-1 overallStatus: COMPLETED date: 2018-07-01 date: 2018-11-30 date: 2018-12-30 date: 2024-03-26 date: 2024-03-26 name: Aventyn, Inc. class: INDUSTRY name: Intel Corporation briefSummary: This is planned as a feasibility study.

The primary objective is to evaluate a specially designed patient monitoring software Vitalbeat and standard mobile device hub termed Intel Health Application Platform (IHAP) in terms of its reliability, seamless data transmission and early data availability to the physician to improve patient physician interaction.

The second objective is assessing patient response to use of mobile device monitoring and patient self-monitoring skills to transmit vital signs data using the IHAP wireless home hub device conditions: Chronic Disease of Cardiovascular System studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10 type: ACTUAL name: Symptoms of chronic illness. measure: Mobile Home Device Hub Data Resiliency measure: Patient Self Monitoring sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Liver Health city: Chandler state: Arizona zip: 85248 country: United States lat: 33.30616 lon: -111.84125 hasResults: False

 nctId: NCT06330701 id: 2023URO0001 briefTitle: Stone Access and Removal (STAR) Study acronym: STAR overallStatus: RECRUITING date: 2024-01-18 date: 2024-12-31 date: 2025-03-31 date: 2024-03-26 date: 2024-04-25 name: Auris Health, Inc. class: INDUSTRY briefSummary: The purpose of the study is to assess procedural completion, the post-operative stone clearance and the safety profile following robotic mini-Percutaneous Nephrolithotomy (PCNL) performed with the MONARCH Platform, Urology. conditions: Kidney Calculi studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 60 type: ESTIMATED name: Robotic-assisted mini-PCNL measure: Percentage of Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL) Kidney Stone Removal Procedure Completed measure: Stone Free Rate (%) measure: Number of Adverse Events measure: Number of Procedure Conversions to Conventional Treatment Methods due to study device-related safety event sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Indiana University status: RECRUITING city: Bloomington state: Indiana zip: 47401 country: United States lat: 39.16533 lon: -86.52639 facility: UW School of Medicine and Public Health status: RECRUITING city: Madison state: Wisconsin zip: 53705 country: United States lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06330688 id: ΕΒΔ 53/25.01.2024 briefTitle: Prospective Evaluation of Ultrasound-guided Percutaneous Cholecystostomy With the Trocar Technique overallStatus: RECRUITING date: 2024-03 date: 2026-03 date: 2026-06 date: 2024-03-26 date: 2024-03-26 name: Attikon Hospital class: OTHER briefSummary: The purpose of this study is to further evaluate and investigate the safety and efficacy of ultrasound (US)-guided percutaneous cholecystostomy (PC) with the trocar technique by the patient's bedside. conditions: Cholecystitis, Acute conditions: Cholecystitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: percutaneous cholecystostomy measure: Technical success measure: Procedure-related complications measure: duration of the procedure measure: intraprocedural and post-procedural pain measure: clinical success sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Attikon University Hospital status: RECRUITING city: Chaïdári state: Athens zip: 12461 country: Greece name: Stavros Spiliopoulos, MD, Associate Professor role: CONTACT phone: +302105831812 email: stavspiliop@gmail.com lat: 38.01135 lon: 23.66597 hasResults: False

 nctId: NCT06330675 id: 2022-01820 briefTitle: Correct Mobilization Time After CIED Implantation: A Single-centre, Open-label, Non-inferiority RCT overallStatus: RECRUITING date: 2023-02-01 date: 2027-02-01 date: 2027-06-01 date: 2024-03-26 date: 2024-03-26 name: Caporali Elena class: OTHER name: Cardiocentro Ticino briefSummary: Bedrest is usually prescribed for patients management after cardiac electronic device implantation (CIED) in order to prevent complication. Due to the lack of guidelines available on the timing of postoperative mobilization management, the aim of the study is to evaluate the safety of early mobilization, comparing mobilization at 4-h against day-after procedure. conditions: Pacemaker conditions: Defibrillators, Implantable studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 558 type: ESTIMATED name: Early mobilization name: Standard of care measure: Composite endpoint: pacing lead dislodgement, pocket hematoma, pneumothorax, and pericardial effusion measure: Post-operative pain measure: Sleep disturbance measure: Postoperative urinary retention measure: Delirium measure: Orthostatic intolerance measure: Quality of recovery measure: Pressure ulcer measure: Incidence of pacing lead dislodgement, pocket hematoma, pneumothorax, pericardial effusion, and pocket infection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cardiocentro Ticino Institute - EOC status: RECRUITING city: Lugano zip: 6900 country: Switzerland name: Elena Caporali, MD role: CONTACT lat: 46.01008 lon: 8.96004 hasResults: False

 nctId: NCT06330662 id: 05-PA-30-19-6/2023. briefTitle: Effectiveness of Hyaluronic Acid on Multiple Adjacent Gingival Recessions Using a Coronally Advanced Flap overallStatus: ENROLLING_BY_INVITATION date: 2023-09-01 date: 2024-09-01 date: 2025-06-01 date: 2024-03-26 date: 2024-03-26 name: Andelina Sekelja class: OTHER briefSummary: The goal of this clinical randomized trial is to examine the effectiveness of hyaluronic acid in treatment of multiple adjacent gingival recessions in 2 groups. Control group will be presented by using a coronally advanced flap only (CAF) and experimental group will be presented with addition of hyaluronic acid to a coronally advanced flap (CAF+HA). The main question it aims to answer is: is there any difference in the reduction of multiple gingival recessions between the control (CAF) and the test group (CAF + HA)? The research would be conducted on subjects referred for specialist treatment at the Department of Periodontology (Faculty of dental medicine, University of Zagreb). A record would be kept of all patients who underwent a detailed clinical examination, those who did not meet the criteria for inclusion in the study and those who refused to participate in it. Participants who meet the inclusion criteria will undergo a detailed clinical examination and if they agree to participate in the research, they will sign the informed form. During the pre-treatment, patients will receive instructions and a demonstration on proper maintenance of oral hygiene as well as a teeth cleaning. In addition to the informed form, they will fill out the OHIP-14 questionnaire, and the researcher will measure the periodontal indices at the very beginning before the operation, as well as the Schiff index. Patients will be photographed at the baseline as well as at follow-up examinations. The total number of subjects would be 42, or 21 patients in the 2 observed groups. The control group refers to surgical intervention using a coronally advanced flap to cover multiple gingival recessions without the addition of hyaluronic acid (CAF) and the experimental group indicates the surgical intervention using a coronally advanced flap to cover multiple adjacent gingival recessions with the addition of hyaluronic acid intraoperatively (CAF + HA). conditions: Gingival Recession studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The control group refers to surgical intervention using a coronally advanced flap to cover multiple gingival recessions without the addition of hyaluronic acid (CAF) and the experimental group indicates the surgical intervention using a coronally advanced flap to cover multiple adjacent gingival recessions with the addition of hyaluronic acid intraoperatively (CAF + HA). primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Randomization would first be generated using a computer-selected program, and then the protocol itself would be placed in opaque sealed envelopes and handed to the operator immediately before the procedure with a decision as to whether or not hyaluronic acid (HA) would be applied. In treated areas where HA will not be applied, the operative site will be treated only with saline. The patient as well as the researcher and the outcomes assesssor will not be informed which patient belongs to which group. Randomization and allocation of envelopes as well as allocation of patients to groups will be determined by a fourth party. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: Testing the effectiveness of hyaluronic acid in experimental group using a coronally advanced flap compared to a control group using a coronally advanced flap only measure: The effect of hyaluronic acid on recession reduction measure: To examine the effect of tissue thickness on recession coverage (KTt) measure: To examine keratinized gingiva width (KTw) measure: To examine changes in periodontal clinical parameters: PPD measure: To examine changes in periodontal clinical parameters: CAL measure: To examine changes in periodontal clinical parameters: REC measure: To examine changes in periodontal clinical parameters: FMPS (full mouth plaque score) measure: To examine changes in periodontal clinical parameters: FMBS (full mouth bleeding score) measure: Assess the healing quality of the operated area by using a RES scale measure: Schiff test tooth examination measure: To examine the impact of oral health on quality of life measure: To evaluate the level of pain postoperatively during the healing of the surgical wound sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Zagreb - School of dental medicine city: Zagreb state: Hrvatska zip: 10 000 country: Croatia lat: 45.81444 lon: 15.97798 hasResults: False

 nctId: NCT06330649 id: 2024-0095 briefTitle: The Acute Effect of and Energy Drink vs. Water Consumption on MAP, HR, and Energy Metabolism overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2025-08-31 date: 2024-03-26 date: 2024-03-26 name: The University of Texas at Arlington class: OTHER briefSummary: The objective of this protocol is to investigate the effect of consumption of a commercially available energy drink beverage on blood pressure, heart rate, and energy metabolism conditions: Cardiovascular Diseases conditions: Hypertension conditions: Diet studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Individuals will be randomly assigned to either an experimental or a control condition. primaryPurpose: PREVENTION masking: SINGLE whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: Energy Drink name: Water Control measure: Peripheral blood pressure in millimeters of mercury measure: Oxygen consumption milliliters per kilogram of body weight per minute measure: Heart rate in beats per minute sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: UT Arlington - Science and Engineering Innovation and Research Building status: RECRUITING city: Arlington state: Texas zip: 76019 country: United States name: Robert M Brothers, PhD role: CONTACT phone: 817-272-3288 email: matthew.brothers@uta.edu name: Alison Mancera, BS role: CONTACT phone: 8172723288 email: alison.mancera@mavs.uta.edu lat: 32.73569 lon: -97.10807 hasResults: False

 nctId: NCT06330636 id: 336-0723 briefTitle: The Acute Effect of D-allulose Consumption on Postprandial Glycaemia overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-11 date: 2024-03-28 date: 2024-07-31 date: 2024-03-26 date: 2024-04-09 name: University of Nottingham class: OTHER briefSummary: The rare sugar D-Allulose, when consumed in a drink before eating has been shown to reduce the blood glucose response to high carbohydrate drinks or meals in people who are healthy, or have elevated fasting blood glucose concentration. However, the effectiveness of D-allulose to suppress blood glucose concentration when added into carbohydrate containing food products has not been previously reported and as the potential use of allulose is as a sucrose replacer in foods, rather than drinks, it is important that effects and efficacy are tested in this format. The study aimed to extend understanding of the acute effects of D-allulose consumption in humans by testing whether post-eating blood glucose concentration can be modified by the presence of D-allulose in a high carbohydrate breakfast and collecting data on any adverse gastrointestinal effects of consuming D-allulose. conditions: Sugar; Blood, High studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomised, placebo controlled cross over design primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Allocation coded A and B, with independent researcher determining allocation and making up the test breakfasts for the study team. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 12 type: ACTUAL name: D-Allulose name: Sodium Saccharin measure: Incremental area under the curve (iAUC) 180 Glucose Test measure: iAUC 180 Glucose Placebo measure: Glycaemia Test measure: Glycaemia Placebo measure: Insulinemia Test measure: Insulinemia Placebo measure: iAUC 180 Insulin Test measure: iAUC 180 Insulin Placebo measure: iCAS Test measure: iCAS Placebo measure: abdominal discomfort test measure: abdominal discomfort placebo measure: Dietary Fibre measure: Carbohydrate % measure: Fat % measure: Protein % measure: Sugars % sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: David Greenfield Human Physiology Laboratories city: Nottingham state: Notts zip: NG72UH country: United Kingdom lat: 52.9536 lon: -1.15047 hasResults: False

 nctId: NCT06330623 id: 0929 id: 321895 type: OTHER domain: HRA briefTitle: Developing Personalised Relative Physical Activity Thresholds in COPD. acronym: IMPACT overallStatus: RECRUITING date: 2023-11-22 date: 2025-03-30 date: 2025-09-01 date: 2024-03-26 date: 2024-03-26 name: University of Leicester class: OTHER briefSummary: The aim of this observational study is to translate the principle of individualised exercise prescription into the evaluation of daily absolute and relative intensity physical activity.

The main questions this study aims to answer are:

* Phase 1: What does physical activity (intensity) mean to people with COPD?
* Phase 2: Are there differences between time spent in absolute and relative physical activity for people with COPD?

Phase 1 Participants will take part in semi-structured interview (30-45 minutes) about living with COPD and perceptions of physical activity and how they perceive intensity. This will also include photovoice and photo-elicitation. Demographic information will be recorded and participants will also complete several respiratory symptom questionnaires.

Phase 2:

Participants will take part in physical activity testing before and after pulmonary rehabilitation while wearing physical activity monitors. Demographic information will be recorded and participants will also complete several respiratory symptom and physical activity questionnaires. Participants will also wear the physical activity monitors for 8 days after the pre-testing sessions and after their final pulmonary rehabilitation class.

Sub-study:

Participants will be asked to take images of barriers during physical activity, facilitators during physical activity, feelings during physical activity and types of physical activity they take part in for 8 days after their final pulmonary rehabilitation class. Participants will then take part in a semi-structured interview about the images their have taken while doing physical activity. conditions: Chronic Obstructive Pulmonary Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 70 type: ESTIMATED measure: Phase 1 - Semi-structured Interviews measure: Phase 2 - Differences between time spent in PA intensity expressed in absolute and relative intensity. measure: Phase 1 - Medical Research Council (MRC) Dyspnoea Scale measure: Phase 1 - COPD Assessment Test (CAT) measure: Phase 1 - Chronic Respiratory Questionnaire (CRQ-SR) measure: Phase 1 - Photovoice and photo-elicitation measure: Phase 2 - Medical Research Council (MRC) Dyspnoea Scale measure: Phase 2 - COPD Assessment Test (CAT) measure: Phase 2 - Chronic Respiratory Questionnaire (CRQ-SR) measure: Phase 2 - Gait Analysis measure: Phase 2 - Exercise Capacity (ISWT) measure: Phase 2 - Exercise Capacity (ESWT) measure: Daily PROactive Physical Activity instrument in COPD (D-PPAC) measure: Phase 2 - Photovoice and photo-elicitation sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NIHR Leicester Biomedical Research Centre - Respiratory status: RECRUITING city: Leicester state: Leicestershire zip: LE67 2DU country: United Kingdom name: Phoebe H Lloyd-Evans role: CONTACT phone: +441162502758 email: phile1@leicester.ac.uk name: Mark W Orme role: CONTACT email: mwo4@leicester.ac.uk name: Mark W Orme role: PRINCIPAL_INVESTIGATOR lat: 52.6386 lon: -1.13169 hasResults: False

 nctId: NCT06330610 id: 2021/0378/HP briefTitle: Evaluation of the Efficiency of Intermittent Enteral Nutrition on Multi-organ Failure From Patients With Mechanical Ventilation in Intensive Care Unit acronym: ENNUT-CI overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-06-01 date: 2027-08-01 date: 2024-03-26 date: 2024-03-26 name: University Hospital, Rouen class: OTHER briefSummary: This study aims to evaluate the efficiency of intermittent enteral nutrition versus continuous enteral nutrition to prevent from organ failures for patients at the acute phase of sepsis shock with mechanical ventilation in ICU. conditions: Intermittent Fasting conditions: Septic Shock conditions: Organ Failure, Multiple studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 174 type: ESTIMATED name: Intermittent enteral nutrition measure: Evolution of variation of the SOFA (Sepsis-related organ failure assessment) score. measure: evaluation of caloric intake measure: evaluation of protein intake measure: Measurement of nutritionnal status measure: Evaluation of the digestive symptoms measure: Evaluation of the nosocomial infections measure: Evaluation of the metabolic response measure: Evaluation of the duration of hospitalisation measure: Evaluation of the intensive care neuromuscular weakness measure: Evaluation of death measure: Evaluation of quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06330597 id: 21-5196 briefTitle: NIVIA-Hemodynamics overallStatus: RECRUITING date: 2021-07-17 date: 2024-08-31 date: 2024-12-31 date: 2024-03-26 date: 2024-03-26 name: University Health Network, Toronto class: OTHER briefSummary: This is an investigator-initiated, single-center, single-arm prospective study to compare non-invasive hemodynamic assessment using transthoracic echocardiography (TTE) and lung ultrasound (LUS) and hemodynamic assessment using PAC. Patients who have been hemodynamically assessed using PAC will be invited to participate. Each patient will undergo TTE and LUS immediately after first invasive assessment, and again daily after PAC assessments. conditions: Cardiogenic Shock conditions: Heart Failure conditions: Shock conditions: Hemodynamic Instability studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Echocardiography and lung ultrasound measure: Correlation between E/e' ratio and PCWP vs. correlation between lung ultrasound score and PCWP. measure: Correlation between cardiac output measured by echocardiography (using LVOT diameter and VTI) and by PAC (using thermodilution) measure: Correlation between right atrial pressure assessed by echocardiography (using IVC diameter and respiratory variation) and by PAC measure: Correlation between pulmonary pressure assessed by echocardiography (using TR max velocity and estimated RAP) and by PAC measure: Correlation between pulmonary pressure assessed by echocardiography (using PAT) and by PAC measure: Correlation between PVR assessed by echocardiography (using PAT) and by PAC measure: Correlation between right ventricular function assessed by echocardiography (using TAPSE and S') and by PAC (using PAPI and RVSWI) measure: Correlation between E/e' ratio and PCWP vs. correlation between lung ultrasound score and PCWP. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network status: RECRUITING city: Toronto state: Ontario zip: M5G 2N2 country: Canada name: Yishay Szekely, MD role: CONTACT phone: 4163404800 email: Yishay.szekely@uhn.ca lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06330584 id: AIM Care Study briefTitle: Administration of Intranasal Midazolam for Anxiety in Palliative Care acronym: AIM Care overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-10-31 date: 2024-10-31 date: 2024-03-26 date: 2024-03-26 name: Insel Gruppe AG, University Hospital Bern class: OTHER name: University Hospital, Basel, Switzerland name: University Hospital, Zürich name: Stadtspital Zürich briefSummary: The goal of this double-blind, randomized, placebo-controlled parallel-group multicenter exploratory pilot study (three study arms) is to describe effects and safety of different doses of intranasal midazolam to treat acute anxiety in palliative care patients, while providing pharmacokinetic and pharmacodynamic data. conditions: Anxiety conditions: Acute Anxiety studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-blind, randomized, placebo-controlled parallel-group multicenter exploratory pilot study with 3 study arms primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: All study personnel except the personnel at the facility preparing the investigational medicinal product (IMP) (Hospital Pharmacy, University Hospital Basel), and all patients will be blinded to the assigned treatment. Allocation will be concealed using sequentially coded drug packs (using consecutive patient identification numbers from 1 to at least 30) containing the IMP that are otherwise identical. Each drug pack will contain two nasal sprays of identical appearance. Patients and all trial personnel involved in recruitment and care of patients, trial assessment, monitoring, and analyses will be blinded to the assigned trial arm. Blinding will be upheld until the last patient (at least 30 patients, i.e., at least 10 per study arm) has completed the pilot study and data entry into the trial database has been completed.

To safeguard blinding, placebo formulation will be produced with the same pH as the active study drug formulations to mimic nasal irritation induced by verum sprays. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Placebo Nasal Spray 0 mg/spray name: Midazolam Nasal Spray 0.45 mg/spray name: Midazolam Nasal Spray 0.9 mg/spray measure: Change from baseline in anxiety levels, measured by Visual Analogue Scale (VAS) measure: Change from baseline in anxiety levels, measured by Numerical Rating Scale (NRS) measure: Sedation measure: Oxygen saturation SaO2 (percent %) measure: Heart rate (bpm) measure: Cortisol levels in oral fluid measure: Time to first requested additional dose measure: Cumulative number of doses over 24 hours measure: Number of patients with adverse drug events (ADEs) measure: Peak plasma concentration (Cmax) measure: Time to reach the peak plasma concentration (Tmax) measure: Elimination half-life (t1/2) measure: Area under the curve (AUC0-Τ, AUC0-∞) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inselspital, Universitätsspital Bern city: Bern zip: 3010 country: Switzerland name: Manuel Haschke, MD role: CONTACT phone: +41 (0)31 632 67 93 email: manuel.haschke@insel.ch name: Manuel Haschke role: PRINCIPAL_INVESTIGATOR lat: 46.94809 lon: 7.44744 facility: Universitäres Zentrum für Palliative Care (UZP) city: Bern country: Switzerland name: Steffen Eychmüller, MD role: CONTACT phone: +41 (0)31 632 51 07 email: steffen.eychmueller@insel.ch lat: 46.94809 lon: 7.44744 facility: Zentrum für Palliative Care, Stadtspital Zürich city: Zürich zip: 8037 country: Switzerland name: Andreas Major, MD role: CONTACT phone: +41 (0)44 417 29 26 email: andreas.major@stadtspital.ch lat: 47.36667 lon: 8.54999 facility: Kompetenzzentrum Palliative Care, Universitätsspital Zürich city: Zürich zip: 8091 country: Switzerland name: Caroline Hertler, MD role: CONTACT phone: +41 (0)44 255 29 34 email: caroline.hertler@usz.ch lat: 47.36667 lon: 8.54999 hasResults: False

 nctId: NCT06330571 id: Aligners in distalization briefTitle: The Efficiency of Clear Aligners in Maxillary Molar Distalization: A Randomized Clinical Trial. acronym: Aligner overallStatus: RECRUITING date: 2024-04-27 date: 2025-01-15 date: 2025-07-15 date: 2024-03-26 date: 2024-03-26 name: Ain Shams University class: OTHER briefSummary: The aim of this study is to evaluate the accuracy of clear aligners on the amount of the maxillary molar distalization. conditions: Orthodontic Aligners studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 10 type: ESTIMATED name: Molar distalization by aligners with attachment measure: Efficiency of aligners in molar distalization measure: Amount of anchorage loss measure: Amount of molar tipping sex: ALL minimumAge: 15 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Ainshams university status: RECRUITING city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06330558 id: pheos briefTitle: Side-specific Factors for Conversion in Adrenalectomy for Pheochromocytoma. overallStatus: COMPLETED date: 2016-09-01 date: 2023-09-01 date: 2023-09-01 date: 2024-03-26 date: 2024-03-28 name: Zagazig University class: OTHER_GOV briefSummary: Context: Adrenalectomy for pheochromocytoma (PHEO) poses difficulties due to the elevated chance of conversion. The objective of this study was to conduct a comparative analysis of the occurrence and determinants of conversion in left-sided abdominal laparoscopic adrenalectomy (LLA) and right-sided abdominal laparoscopic adrenalectomy (RLA).

Methods: A retrospective analysis was conducted to include a total of 271 patients diagnosed with PHEO. These patients were separated into two groups: LRA (N=121) and LLA (N=150). The study period spanned from September 2016 to September 2023. conditions: Adrenal Tumor studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 271 type: ACTUAL name: laparoscopic right adrenalectomy measure: conversion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06330545 id: STUDY02002161 briefTitle: Radiation Therapy for Dupuytren's Contracture Following Non-Surgical Release overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2029-04 date: 2032-04 date: 2024-03-26 date: 2024-03-26 name: Dartmouth-Hitchcock Medical Center class: OTHER briefSummary: The goal of this study is to learn about preventing recurrence of Dupuytren's Contracture. The main question it aims to answer are:

• Does targeted radiation therapy decrease recurrence of Dupuytren's contracture after treatment with Collagenase Clostridium Histolyticum?

Participants will undergo:

* Release of Dupuytren's Contracture after Collagenase Clostridium Histolyticum injection
* Daily radiation therapy treatment for 5 days followed by 6-8 week rest period and then another course of 5 days of radiation therapy conditions: Dupuytren Contracture studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a prospective phase II trial where patients diagnosed with late/advanced stage Dupuytren's Contracture (DC) who undergo successful CCH injection and release will receive a standardized regimen of radiotherapy (RT). The study will be powered to assess the outcome in patients undergoing the combination of successful release followed by RT. Patients will be monitored for acute and late toxicities while we evaluate disease recurrence defined as a \> 20 degree worsening of contracture in the presence of a palpable cord, or the need for medical/surgical intervention to correct the new or worsening contracture. primaryPurpose: PREVENTION masking: NONE count: 95 type: ESTIMATED name: Radiation therapy measure: Recurrence of Dupuytren's Contracture measure: Radiation Toxicity measure: Patient Reported Outcomes after Radiation Treatment (RT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06330532 id: 4-2023-1526 briefTitle: Impact of Preoperative Frailty and Cognitive Impairment on Postoperative Outcomes in Elderly Cardiac Surgery Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-01 date: 2025-02-28 date: 2025-02-28 date: 2024-03-26 date: 2024-03-26 name: Yonsei University class: OTHER briefSummary: This is a retrospective study of patients aged 65 years and older who underwent cardiac and aortic surgery between March 5, 2021 and October 12, 2022 in the operating room of Severance Cardiovascular Hospital to determine the impact of physical frailty as well as nutritional status, emotional dysregulation, and cognitive dysfunction on postoperative outcomes. Physical frailty will be determined by the Clinical Frailty Scale, handgrip strength, and nutritional status, cognitive dysfunction will be determined by the K-MMSE and K-MoCA administered at the preoperative interview, and emotional dysregulation will be determined using the SGDS-K. These were measured during the pre-anesthesia evaluation and only results from patients who agreed to be tested will be used. Nutritional status will be analyzed based on blood test values measured within one month of surgery. conditions: Cardiovascular Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 450 type: ESTIMATED measure: postoperative all cause mortality measure: major composite morbidity measure: the number of days not in hospital measure: The number of participants who die sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Yonsei University Health system, Severance Hospital city: Seoul zip: 03722 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06330519 id: Ainshams University Dentistry briefTitle: Impact of Different Techniques on The Efficacy of Anaesthesia in Mandibular Molars With Acute Irreversible Pulpitis overallStatus: COMPLETED date: 2023-09-25 date: 2024-02-21 date: 2024-02-21 date: 2024-03-26 date: 2024-03-26 name: Ain Shams University class: OTHER briefSummary: The goal of this clinical trial is to assess the effect of

* Preoperative intraligamentary corticosteroids injection
* Cryotherapy which is cold application on :

  * Hard tooth structure ( crown of the tooth )
  * Soft tissue overlying roots on the efficacy of the inferior alveolar nerve block anaesthesia in patients with mandibular molars with symptomatic irreversible pulpitis. The main question it aims to answer are: • Does intraligamentary dexamethazone injection increase the success rate of inferior alveolar nerve block without the need for oral premedication.

Participants will describe their preoperative pain level to the investigator and describe their pain level during the treatment.

Researchers will compare cryotherapy to see if it increases the success rate of inferior alveolar nerve block. conditions: Pulpitis - Irreversible studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 72 type: ACTUAL name: Dexamethasone sodium phosphate injection name: 1,1,1,2 tetrafluoroethane name: intraoral soft tissue cryotherapy measure: The effect of intraligamentary dexamethazone injection on the success rate of inferior alveolar nerve block sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Ain Shams University city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06330506 id: 123456123456 briefTitle: The Effect of Pressure Ulcer Care Package on the Risk of Pressure Ulcer Development overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-08-10 date: 2024-09-10 date: 2024-03-26 date: 2024-03-26 name: Cukurova University class: OTHER briefSummary: This study aimed to determine the effect of pressure ulcer care package use on the risk of pressure ulcer development due to surgery in patients undergoing orthopedic surgery. It was planned as a randomized controlled study. The population of the study will consist of patients who underwent surgery in the Orthopaedics and Traumatology Clinic of Doğubayazıt Dr.Yaşar Eryılmaz State Hospital Hospital Hospital of Ağrı Provincial Health Directorate. The sample of the study will consist of patients who volunteered to participate in the study that meets the inclusion criteria. To obtain research data, the Personal Information Form developed by the researcher in line with the literature, 3S Operating Theatre Pressure Wound Risk Assessment Scale, Pressure Wound Regions and Stages Monitoring Form prepared according to NPUAP (2016) Pressure Wound Staging System Form will be used. Statistical analysis of the data obtained from the study will be performed using the SPSS 25 (Statistical Package of Social Science) package program. conditions: Pressure Ulcer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 102 type: ESTIMATED name: Pressure ulcer prevention pack measure: Evaluation of pressure ulcer formation sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06330493 id: AcoArt BTK Global Trial briefTitle: AcoArt Litos PCB Below-the-knee Global Trial overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-10 date: 2030-12 date: 2024-03-26 date: 2024-04-29 name: Acotec Scientific Co., Ltd class: INDUSTRY briefSummary: The objective of this study is to assess whether efficacy of the AcoArt Litos PCB is superior and whether safety of AcoArt Litos PCB is noninferior to the control device (FDA cleared PTA Balloon Catheter) regarding treatment of obstructions in the infrapopliteal arteries (located distal to the P3 segment of the popliteal artery and extending to the tibiotalar joint) in patients presenting with chronic limb-threatening ischemia (CLTI)(Rutherford 4-5) conditions: Chronic Limb-Threatening Ischemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 288 type: ESTIMATED name: PCB name: PTA measure: Primary Efficacy Endpoint: Composite of freedom from major amputation and primary patency measure: Primary Safety Endpoint: Composite of MALE and POD (Major Adverse Limb Event + Peri-Operative Death) measure: Composite of Limb Salvage and Primary Patency measure: Patency rate measure: Freedom from CD-TLR measure: Re-occlusion rate of target lesion measure: Rate of Major adverse events(MAE) measure: Rate of target limb major amputation measure: Rate of all-cause death measure: Amputation free survival rate measure: Change in ankle-brachial index(ABI) measure: Change in toe-brachial index(TBI) measure: Change in Rutherford category measure: Change in EQ-5D measure: Change in VascuQol measure: Primary sustained clinical improvement measure: Secondary sustained clinical improvement measure: Wound healing measure: Rate of Device Success measure: Rate of Technical Success measure: Rate of Procedure Success sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06330480 id: Check@Home briefTitle: Check@Home: General Population Screening for Early Detection of Atrial Fibrillation and Chronic Kidney Disease overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2027-11-01 date: 2028-11-01 date: 2024-03-26 date: 2024-03-26 name: Prof. Dr. Folkert W. Asselbergs class: OTHER name: Dutch Cardiovascular Alliance name: University Medical Center Groningen name: Dutch Heart Foundation name: Dutch Kidney Foundation name: Dutch Diabetes Research Foundation name: Maastricht University name: AstraZeneca BV name: UMC Utrecht name: Radboud University Medical Center name: Siemens Healthineers Nederland BV name: University of Twente name: Roche Diagnostics Nederland BV name: Luscii healthtech BV name: Happitech BV name: Stichting Radboud Universiteit name: Stichting Netherlands Heart Institute briefSummary: The aim of the Check@Home consortium is to set up a roadmap and infrastructure for a program to early detect atrial fibrillation and chronic kidney disease in the general population.

This will be a population-based screening with a phased implementation and an iterative design in four regions in the Netherlands (Breda, Utrecht, Arnhem, Eindhoven). In total, a random sample of 160,000 people (aged 50-75 years) will be invited to participate in the study and another random sample of 160,000 people with the same characteristics will be included in the control group in which no screening will be offered.

The overall screening program will consist of three phases: a home-based testing phase, diagnostic screening phase, and a treatment phase:

* Phase 1: Subjects will be invited for a home-based screening that includes home-based testing; urine collection for detection of elevated albuminuria, and a heart rhythm measurement using a smartphone app for detection of atrial fibrillation.
* Phase 2: Depending on the results on these home-based tests, subjects will be invited for further screening in a diagnostic screening facility. During this visit, physical data will be collected (height, weight, waist circumference, blood pressure, heart rhythm), blood will be drawn, and urine will be collected for the assessment of parameters that are indicative of a cardiovascular disease, chronic kidney disease, type 2 diabetes or their risk factors. Participants will receive a questionnaire that include questions on demographics, educational level, disease history, medication use, health literacy, and quality of life.
* Phase 3: Based on the results of the diagnostic screening, participants may be referred to their general practitioner for appropriate treatment (lifestyle advice/medication) according to the prevailing guidelines.

The primary study outcomes are:

Overall effectiveness of population based screening on atrial fibrillation and chronic kidney disease in subjects aged 50-75 years, based on:

* Participation rate of different screening strategies and phases;
* Yield of the screening (number of subjects with (newly) diagnosed disease and risk factors);
* Effectiveness of the atrial fibrillation screening, compared with standard care, based on the incidence of ischemic stroke);
* Effectiveness of the albuminuria screening, compared with standard care, based on the incidence of kidney failure events and Major Adverse Cardiovascular Events (MACE). conditions: Atrial Fibrillation conditions: Chronic Kidney Diseases conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Check@Home is a population-based screening with a phased assessment and implementation using an iterative design executed consecutively in four regions in the Netherlands. primaryPurpose: SCREENING masking: NONE count: 320000 type: ESTIMATED name: Intervention group measure: Participation rate of the atrial fibrillation and albuminuria screening measure: Yield of the atrial fibrillation and albuminuria screening measure: Effectiveness of the atrial fibrillation screening measure: Effectiveness of the albuminuria screening measure: Effectiveness of the atrial fibrillation screening based on incidence of MACE events measure: Effectiveness of the albuminuria screening based on incidence each individual MACE component measure: Safety of the atrial fibrillation screening measure: Cost-effectiveness of screening strategies compared with standard of care: treatment effectiveness based on literature. measure: Cost-effectiveness of screening strategies compared to standard of care: treatment effectiveness based on actual observed event rates measure: False-positive rate, false-negative rate, sensitivity, specificity, positive predictive screening on atrial fibrillation and albuminuria screening. measure: Characteristics of responders and non-responders measure: Effectiveness of the atrial fibrillation screening based on incidence each individual MACE component measure: Overall effectiveness of broader population-based screening strategies applied to screening on heart failure, coronary artery disease, and type 2 diabetes. sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06330467 id: 2023-A02442-43 id: RIPH 2023-02 type: REGISTRY domain: sponsor's internal reference briefTitle: Prevalence of Dissociative Identity Disorder in At-risk Outpatient Groups Reporting Childhood Trauma. acronym: IDENTITY overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-31 date: 2026-06-30 date: 2024-03-26 date: 2024-03-28 name: Centre Psychothérapique de Nancy class: OTHER briefSummary: The investigators will study the prevalence of dissociative identity disorder (DID) in three populations at risk in cases of childhood psychotrauma : patients with a diagnosis of borderline personality, patients with a diagnosis of functional dissociative crises (FDC) and patients with early psychosis.

The investigators will also study the prevalence of other dissociative disorders and the frequency of complex post-traumatic stress disorder.

The investigators will also look for correlations between the type of maltreatment in childhood, the age of onset of trauma and the type of diagnosis of dissociative disorders.

The investigators hope to include 150 borderline patients, 150 FDC patients and 50 early psychosis patients.

Data collection will be done via a psychometric administration of 7 self-completion questionnaires as well as the completion of the SCID-D semi-structured interview. conditions: Dissociative Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 3 groups : borderline, early psychosis and FDC. primaryPurpose: DIAGNOSTIC masking: NONE count: 350 type: ESTIMATED name: psychometric assessment name: semi-structured clinical interview measure: SCID-D : Semi-structured Clinical Interview for diagnosing DSM-5 and ICD-11 Dissociative Disorders / DSM = Diagnostic and Statistical Manual of Mental Disorders / ICD = International Classification of Diseases measure: SCID-D : Semi-structured Clinical Interview for diagnosing DSM-5 and ICD-11 Dissociative Disorders measure: CTQ-28 : Childhood Trauma Questionnaire measure: life events inventory DSM-5 measure: PCL-5 : Posttraumatic stress disorder CheckList-5 measure: ITQ : International Trauma Questionnaire measure: SDQ-20 : Somatoform Dissociative questionnaire measure: DIS-Q : Dissociation Questionnaire measure: DES : Dissociative Experience Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Psychothérapique de Nancy - CLIP city: Nancy country: France name: Vincent LAPRÉVOTE role: CONTACT email: vincent.laprevote@cpn-laxou.com name: Vincent LAPRÉVOTE role: PRINCIPAL_INVESTIGATOR name: Lori PETROCELLI role: SUB_INVESTIGATOR lat: 48.68439 lon: 6.18496 facility: Centre Psychothérapique de Nancy - CMP Jacquard et Des Près city: Nancy country: France name: Coraline HINGRAY role: CONTACT email: coraline.hingray@cpn-laxou.com name: Coraline HINGRAY role: PRINCIPAL_INVESTIGATOR name: Lori PETROCELLI role: SUB_INVESTIGATOR lat: 48.68439 lon: 6.18496 facility: CHRU Nancy - Neurology department city: Nancy country: France name: Coraline HINGRAY role: CONTACT email: coraline.hingray@cpn-laxou.com name: Coraline HINGRAY role: PRINCIPAL_INVESTIGATOR name: Alexis TARRADA role: SUB_INVESTIGATOR name: Séverine CONRADI role: SUB_INVESTIGATOR name: Lori PETROCELLI role: SUB_INVESTIGATOR lat: 48.68439 lon: 6.18496 hasResults: False

 nctId: NCT06330454 id: 483/2020/Disp/AOUFe briefTitle: Painful Total Knee Replacement (TKA) and I-one Therapy overallStatus: RECRUITING date: 2020-10-22 date: 2025-10-21 date: 2025-10-21 date: 2024-03-26 date: 2024-03-28 name: University Hospital of Ferrara class: OTHER briefSummary: Arthroplasty operations are very frequent and their number is constantly increasing. The success of prosthetic surgery is linked to surgical factors (prosthesis type, prosthesis design, prosthesis material, surgical hand) and 'biological' factors (inflammation, pain, oedema, impingement). It is well known that important functional limitations may result mainly from an overreaction involving the peri-articular tissues. This is particularly true after total knee arthroplasty (TKA) surgery, during which a large part of the bone tissue and part of the peri-articular tissues (joint capsule, ligaments, synovium) are dislodged or removed. In the days following arthroplasty operations, the presence of a strong local inflammatory component is associated with pain and functional limitation, which usually resolves within a few months; however, it can sometimes take longer, and sometimes result in a chronic, albeit modest, inflammatory condition that lasts for years. There is still a percentage of 11-25% of patients who remain not completely satisfied with the result achieved with prosthetic surgery . Baker et al. state that 19.8% of patients experience pain one year after arthroplasty . Beswick et al. report that many patients (10-34%) continue to experience significant pain and functional limitation after arthroplasty even years later. conditions: Knee Pain Swelling studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 237 type: ESTIMATED name: I-ONE measure: Evaluate pain resolution after treatment with I-ONE® therapy in patients with painful TKA at least 1 month after surgery. measure: reduced NSAID intake measure: improved recovery of joint function sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Ortopedico Rizzoli status: RECRUITING city: Bologna state: BO country: Italy name: Francesco Traina role: CONTACT lat: 44.49381 lon: 11.33875 facility: Poliambulanza Brescia status: RECRUITING city: Brescia state: BS country: Italy name: Francesco Benazzo role: CONTACT lat: 45.53558 lon: 10.21472 facility: Policlinico San Matteo Pavia status: RECRUITING city: Pavia state: PV country: Italy name: Mario Mosconi role: CONTACT lat: 45.19205 lon: 9.15917 facility: Ospedale Mauriziano Torino status: RECRUITING city: Torino state: TO country: Italy name: Roberto Rossi role: CONTACT lat: 45.07049 lon: 7.68682 facility: Ospedale Sacro Cuore Don Calabria Negrar Verona status: RECRUITING city: Negrar state: VR country: Italy name: Claudio Zorzi role: CONTACT lat: 45.52918 lon: 10.93899 facility: Policlinico di Bari status: RECRUITING city: Bari country: Italy name: Biagio Moretti role: CONTACT lat: 41.11148 lon: 16.8554 facility: Ospedale Santo Spirito in Sassia/Ospedale San Filippo Neri Roma status: RECRUITING city: Roma country: Italy name: Francesco Falez role: CONTACT lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06330441 id: MOU-2021-01 briefTitle: Pancreatic Cancer Screening in a Population at High Risk acronym: ScrePan overallStatus: RECRUITING date: 2022-01-07 date: 2025-01-06 date: 2028-01-06 date: 2024-03-26 date: 2024-04-01 name: Masaryk Memorial Cancer Institute class: OTHER name: Masaryk University briefSummary: Pancreatic cancer is one of the diseases with the worst prognosis, which is mainly due to the initial asymptomatic prognosis. Unfortunately, the incidence of this disease in the Czech Republic is still increasing. In a certain proportion of patients, it is possible to predict the disease, e.g. due to family burdens. Regular follow-up of such individuals is the subject of the SCREPAN study: "Pancreatic Cancer Screening in High-Risk Persons". conditions: Pancreatic Ductal Adenocarcinoma conditions: Hereditary Diseases conditions: Pancreatitis, Chronic studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: SINGLE whoMasked: PARTICIPANT count: 700 type: ESTIMATED name: endoscopic ultrasonography name: magnetic resonance name: laboratory examination measure: Number of participants with newly diagnosed pancreatic ductal adenocarcinoma measure: Methods yield comparison measure: Screening methods cost-effectiveness measure: KRAS mutation status evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Masaryk Memorial Cancer Institute status: RECRUITING city: Brno zip: 65653 country: Czechia name: Martina Lojova, Ph.D. role: CONTACT phone: +420543136232 email: martina.lojova@mou.cz name: Dita Kozakova, Ing. role: CONTACT phone: +420543136236 email: dita.kozakova@mou.cz name: Petr Karasek, MD role: PRINCIPAL_INVESTIGATOR name: Jana Halamkova, MD role: SUB_INVESTIGATOR name: Helena Coupkova, MD role: SUB_INVESTIGATOR name: Anna Ondrackova, MD role: SUB_INVESTIGATOR name: Marketa Palacova, MD role: SUB_INVESTIGATOR name: Radim Nemecek, MD role: SUB_INVESTIGATOR name: Lumir Kunovsky, MD role: SUB_INVESTIGATOR name: Jan Trna, MD role: SUB_INVESTIGATOR name: Lenka Foretova, MD role: SUB_INVESTIGATOR name: Zdenka Cermakova, MD role: SUB_INVESTIGATOR name: Jan Kristek, MD role: SUB_INVESTIGATOR name: Roman Hrstka, Ph.D. role: SUB_INVESTIGATOR lat: 49.19522 lon: 16.60796 hasResults: False

 nctId: NCT06330428 id: MU-Ebe-ZDKY-02 briefTitle: Investigation of the Effect of Sexuality-Based Family Planning Education Given to Women Via Podcast on Contraceptive Method Selection and Sexual Life Quality overallStatus: RECRUITING date: 2024-02-09 date: 2024-06-10 date: 2024-08-10 date: 2024-03-26 date: 2024-03-26 name: Marmara University class: OTHER briefSummary: In this study, it was aimed to examine the effect of Sexuality-Based Family Planning Education given to women of childbearing age via Podcast on contraceptive method selection and sexual life quality.

Accordingly, the hypotheses of the study are as follows:

Hypotheses of the Project H1: Sexuality-based family planning education via podcast has an effect on women's conscious and appropriate contraceptive method selection.

H2: Sexuality-based family planning education via podcast has a positive effect on women's sexual life quality.

H3: Sexuality-based family planning education via podcast has a positive effect on the quality of sexual life of women by increasing their level of contraceptive knowledge.

H4: Sexuality-based family planning education via podcast has a positive effect on women's attitudes towards family planning. conditions: Contraception studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: One control group, one experimental group primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The experimental group will receive sexuality-based family planning education via podcast and outcome assessment will be performed by an investigator who was blinded to group assignment. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 176 type: ESTIMATED name: Sexuality-Based Family Planning Education via Podcast measure: Contraceptive Knowledge Assessment Scale-Turkish Form measure: Sexual Quality of Life Scale-Female measure: Family Planning Attitudes Scale sex: FEMALE minimumAge: 15 Years maximumAge: 49 Years stdAges: CHILD stdAges: ADULT facility: Marmara University status: RECRUITING city: Istanbul country: Turkey name: Meltem Demirgöz Bal role: CONTACT phone: +905056482983 email: meltemdemirgoz@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06330415 id: 25603 briefTitle: Effect and Process Evaluation of the SME Tool overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-08-01 date: 2024-03-26 date: 2024-03-26 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER name: ZonMw: The Netherlands Organisation for Health Research and Development briefSummary: A web-based tool has been developed to help small and medium-sized businesses support employees returning to work after sick-leave. A six-month trial is conducted, randomly assigning employer-employee dyads to either use the tool or receive standard care. The primary aim is to evaluate its impact on employee satisfaction with return-to-work support. conditions: Sick-listed Employees studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 404 type: ESTIMATED name: The SME tool measure: Satisfaction with the RTW support of employer assessed by the employee measure: Social support measure: Total number of sick-leave days measure: Work performance measure: Quality of working Life measure: Self-efficacy measure: Satisfaction with the resumption of work of the respective employee measure: Recruitment measure: Use of the SME tool measure: Perceived usefulness of the SME tool measure: Components of the logic model of change measure: Experiences sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06330402 id: N-20220063 briefTitle: Exploration of Gait Biomechanics and Pain overallStatus: RECRUITING date: 2023-09-26 date: 2026-12-31 date: 2026-12-31 date: 2024-03-26 date: 2024-03-26 name: Kristian Kjær Petersen class: OTHER briefSummary: This interventional study aims to test gait biomechanics in healthy individuals with and without experimental knee pain. The main questions it aims to answer are:

* How do gait patterns change during painful walking?
* Can pain sensitivity testing and gait biomechanics predict experimental knee pain intensity?

Participants will receive two knee injections: a) Hypertonic saline (painful condition) and b) Isotonic saline (control condition). conditions: Pain conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 34 type: ESTIMATED name: Hypertonic saline injection name: Isotonic saline injection measure: Infrared marker XYZ coordinates measure: Pain sensitivity. measure: The Pittsburgh Sleep Quality Index score measure: The Pain catastrophizing Scale score measure: The Hospital Anxiety and Depression Scale measure: Knee symptoms measure: Ground reaction forces measure: Ground reaction moments measure: Ground contact XZ location measure: Muscle activation measure: Pain intensity (NRS 0-10) measure: Pain distribution sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Aalborg University status: RECRUITING city: Aalborg state: Nordjylland zip: 9000 country: Denmark name: Kristian K Petersen, Dr. Med role: CONTACT phone: (+45) 31697510 email: kkp@hst.aau.dk name: Emma Hertel, M. Sc. role: CONTACT phone: (+45) 60887473 email: eh@hst.aau.dk lat: 57.048 lon: 9.9187 hasResults: False

 nctId: NCT06330389 id: MRC-01-20-1074 briefTitle: Burn Injuries During COVID-19 Pandemic and Its Influence on Length of Stay overallStatus: COMPLETED date: 2020-04-01 date: 2021-03-01 date: 2021-06-25 date: 2024-03-26 date: 2024-03-26 name: Hamad Medical Corporation class: INDUSTRY briefSummary: Burn injuries were thought to be difficult to treat during the new corona virus epidemic. Our goal is to determine the risk factors that influence length of hospital stay (LOS) of burn injured patients during COVID -19 pandemic. conditions: SARS-CoV-2 Infection studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 70 type: ACTUAL name: Burn Injuries Graft Surgery measure: Our goal is to determine the risk factors that influence length of hospital stay (LOS) of burn injured patients during COVID -19 pandemic. measure: Clinical diffreneces between burn injuries with positive vs negative COVID-19 status sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: HAMAD Medical Corporation- Al Wakra Hospital city: Doha zip: 82228 country: Qatar lat: 25.28545 lon: 51.53096 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2020-05-30 uploadDate: 2021-09-07T14:07 filename: Prot_SAP_000.pdf size: 273860 hasResults: False

 nctId: NCT06330376 id: PT-2022-30735 briefTitle: Diaphragmatic Breathing Exercises for Post-COVID-19 Diaphragmatic Dysfunction (DD) overallStatus: RECRUITING date: 2024-03-01 date: 2024-06-01 date: 2024-09-01 date: 2024-03-26 date: 2024-04-05 name: University of Minnesota class: OTHER briefSummary: Diaphragm is the principal muscle of inspiration. Diaphragmatic dysfunction is seen in many conditions including following intubation, lung disease, prolonged ventilation, neuromuscular disease, phrenic nerve injury. The possible mechanisms of diaphragmatic dysfunction in patients with COVID19 are critical illness myopathy, ventilator-induced diaphragm dysfunction, iatrogenic phrenic nerve injury particularly secondary to line placement, post-infectious inflammatory neuropathy of the phrenic nerve, or possibly direct neuromuscular involvement of the SARS- CoV-2 virus given expression of the angiotensin- converting enzyme 2 (ACE2) receptor in the peripheral nervous system and skeletal muscle. The use of diaphragmatic ultrasound has been widely used to assess diaphragmatic function is well known in patients following prolonged mechanical ventilation. Prolonged mechanical ventilation leads to contractile dysfunction of respiratory muscles, in particular the diaphragm, causing a so-called ventilator-induced diaphragm dysfunction. The latter is defined as a loss of diaphragm force-generating capacity specifically related to the use of mechanical ventilation. However, the use of diaphragmatic Ultrasound to assess its function in Long COVID patients has not been noted and is a gap in the work up of these patients.

The purpose of this study is to address Diaphragmatic Dysfunctional (DD) breathing seen in patients with Post-Acute Sequelae of COVID-19 (PASC), which results in shortness of breath/chest tightness and subsequent fatigue. Targeting shortness of breath and subsequent fatigue as a central symptom of PASC will alleviate long term sequelae for the patients with PASC. DD will be addressed by a unique intervention of physical therapy. The goal of this prospective randomized clinical study will be to evaluate the comparative treatment effect of DB on markers, specifically fatigue, dyspnea, 6 min walk test, depression/anxiety, and quality of life (QoL). conditions: Post-Acute Sequelae of COVID-19 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: prospective randomized clinical study with 2 arms primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Usual care of traditional treatment name: Specific DB program/Diaphragmatic manipulation program measure: 6-minute walk test (6MWT) measure: PHQ9: Patient health questionnaire 9 measure: GAD7: Generalized anxiety disorder 7-item measure: PROMIS score: Patient-Reported Outcomes Measurement Information System measure: QoL scale: Quality of life scale measure: FACIT fatigue scale 's Fatigue score measure: Modified Borg dyspnea scale measure: RR; respiratory rate with 6 min walk test measure: PR: pulse rate with 6 min walk test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Minnesota status: RECRUITING city: Minneapolis state: Minnesota zip: 55414 country: United States name: Farah Ikramuddin role: CONTACT email: ikram002@umn.edu lat: 44.97997 lon: -93.26384 hasResults: False

 nctId: NCT06330363 id: METC 23-049 briefTitle: The Impact of Low Level Laser Treatment on Skeletal Muscle and Skin Tissue acronym: LASER overallStatus: RECRUITING date: 2024-04-01 date: 2024-08-31 date: 2024-12-31 date: 2024-03-26 date: 2024-04-17 name: Maastricht University Medical Center class: OTHER briefSummary: Rationale: Low level laser therapy, or photobiomodulation, is getting more attention as a non-invasive treatment strategy for numerous conditions. Phototherapy has been applied for more than 40 years for the treatment of musculoskeletal and neurological conditions. Low level laser therapy generally applies red or near-infrared lasers with a wavelength between 600 and 1000 nm and low power wattage from 5 to 500 mW and a power density between 1 and 5 W/cm2. The laser light is absorbed by the skin without thermal damage and penetrates deeply into tissues where it is supposed to induce its physiological effects at the cellular level. Laser therapy has been hypothesized to stimulate mitochondrial respiration, increase tissue oxygenation, and support tissue regeneration. Despite supportive research data on in vitro cell and in vivo animal data, there are surprisingly few data on the proposed impact of low level laser treatment (LLLT) on tissue metabolism in vivo in humans.

Objective: To assess the impact of acute laser treatment on muscle tissue mitochondrial respiration in vivo in healthy, young adults. Secondary objectives include the in vivo assessment of cellular energy, anabolic, angiogenic and inflammatory pathways, along with enzyme activity within muscle and skin.

Study design: Within-subject study.

Study population: 12 healthy (BMI 18.5-30 kg/m2) young (age: 18-35 y) adults (6 men and 6 women).

Intervention: One leg of the subjects will receive LLLT, while the other leg will receive no treatment. After the treatment muscle and skin biopsy samples will be taken from both legs.

Main study parameters/endpoints: The primary outcome will be mitochondrial respiration of the LLLT treated and non-treated leg based on muscle samples. Secondary study parameters are muscle and skin gene expression, protein signalling and enzyme activity. conditions: Muscles Metabolism conditions: Skin Metabolism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Within-subject study primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: One let will receive the laser therapy, the other one will get a sham laser. The person analyzing the samples will be blinded to legs. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 16 type: ESTIMATED name: Laser therapy name: Sham measure: Muscle mitochondrial respiration measure: Gene expression (mRNA) via real-time PCR measure: Protein expression via western blotting measure: Skin mitochondrial respiration sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Maastricht University Medical Centre status: RECRUITING city: Maastricht country: Netherlands name: Luc JC van Loon, PhD role: CONTACT phone: +31-43-3881397 email: l.vanloon@maastrichtuniversity.nl lat: 50.84833 lon: 5.68889 hasResults: False

 nctId: NCT06330350 id: METC 2023-0193 briefTitle: Qualitative Study in Patients With Genodermatoses and Healthcare Professionals on Reproductive Counselling overallStatus: RECRUITING date: 2024-01-01 date: 2025-08-31 date: 2025-12-31 date: 2024-03-26 date: 2024-03-26 name: Maastricht University Medical Center class: OTHER briefSummary: The goal of this observational study is to understand the perspectives and needs of patients with genodermatoses and their partners who wish to have children, regarding their decision-making process and their consideration of reproductive options. Additionally, the investigators aim to investigate the level of knowledge and perspectives of healthcare professionals (such as clinical geneticists, dermatologists and other clinicians involved), and want to explore to what extent patients and their partners are well informed about these reproductive options. To achieve this, the investigators will conduct individual semi-structured qualitative interviews with participants affected by genodermatoses (and their partners) and with healthcare professionals. conditions: Quality of Life conditions: Ichthyosis conditions: Palmoplantar Keratoses conditions: Epidermolysis Bullosa conditions: Ectodermal Dysplasia conditions: Basal Cell Nevus Syndrome conditions: Birt-Hogg-Dube Syndrome conditions: Tuberous Sclerosis conditions: Cutis Laxa conditions: Albinism studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: Qualitative interview measure: Assessment of perspectives of affected patients + partners and of healthcare professionals concerning reproductive decision-making sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Maastricht University Medical Center status: RECRUITING city: Maastricht state: Limburg zip: 6202 AZ country: Netherlands name: Fauve C van Veen role: CONTACT phone: +31433877293 email: genodermatose@mumc.nl lat: 50.84833 lon: 5.68889 hasResults: False

 nctId: NCT06330337 id: ZSLL-KY-2024-010-01 briefTitle: Effect of Electroacupuncture Combined With Paclitaxel Clinical Efficacy of Patients With Recurrence of High-grade Glioma overallStatus: RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2027-12-31 date: 2024-03-26 date: 2024-03-26 name: The Third Affiliated hospital of Zhejiang Chinese Medical University class: OTHER name: Zhejiang University briefSummary: Gliomas are the most common type of primary brain tumors, with surgery followed by radiotherapy and chemotherapy as the main treatment modalities. However, they are highly prone to recurrence, presenting significant treatment challenges, especially for high-grade gliomas, which have a 5-year survival rate of only 5.5%. Paclitaxel, a common chemotherapeutic agent, exhibits antitumor effects in vitro that are 1400 times stronger than those of temozolomide (the first-line chemotherapy drug for gliomas). However, due to its large molecular weight (approximately 893 Da), it cannot cross the blood-brain barrier, precluding its use as a first-line treatment for gliomas. Preliminary research by our team has demonstrated that Specific Mode Electroacupuncture Stimulation (SMES) can open the blood-brain barrier, enhancing the concentration of albumin-bound paclitaxel (ABX) in tumor tissues, peritumoral tissues, and surrounding invasive tissues, thereby exerting antitumor effects. Consequently, this study aims to observe the safety and efficacy of SMES combined with ABX in treating patients with recurrent high-grade gliomas postoperatively, to explore its mechanisms of action, extend survival, improve quality of life, and forge new theories and methods for the integrative treatment of brain tumors combining traditional Chinese and Western medicine. conditions: Glioma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 58 type: ESTIMATED name: Temozolomide（TMZ） injection or oral administration name: Albumin-Bound Paclitaxel(ABX) intravenous drip name: Specific mode electroacupuncture stimulation(SMES) intervention measure: Overall survival（OS） measure: Progression-Free Survival (PFS) measure: Head MRI (plain and enhanced) measure: he Karnofsky Performance Score (KPS) measure: The Eastern Cooperative Oncology Group (ECOG) measure: The Quality of Life (QOL) measure: The Neurological Assessment for Neuro-Oncology (NANO) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University status: RECRUITING city: Zhejiang country: China name: Xianming Lin, PHD role: CONTACT phone: +86-13858028101 email: linxianming1966@163.com name: Zhaoxing Jia, PHD role: CONTACT phone: +86-18356130598 email: zhenxinzhenyi183@163.com hasResults: False

 nctId: NCT06330324 id: METC 2023-0182 briefTitle: Reproductive Options in Inherited Skin Diseases acronym: REPRO-ISD overallStatus: ENROLLING_BY_INVITATION date: 2024-01-01 date: 2026-09-01 date: 2026-09-01 date: 2024-03-26 date: 2024-03-26 name: Maastricht University Medical Center class: OTHER briefSummary: The goal of this observational study is to learn about the indications for prenatal diagnostics and preimplantation genetic testing for patients/couples affected by an inherited skin disease, and evaluate the clinical outcomes of these reproductive options. By providing a complete overview, the investigators aim to improve reproductive counselling for these patients/couples with a desire to have children.

To achieve this, the investigators aim to retrospectively collect data from a cohort of patiens/couples affected by an inherited skin disease on a national level (in the Netherlands) and also an international level from various countries in Europe. conditions: Ichthyosis conditions: Palmoplantar Keratoses conditions: Epidermolysis Bullosa conditions: Ectodermal Dysplasia conditions: Basal Cell Nevus Syndrome conditions: Birt-Hogg-Dube Syndrome conditions: Tuberous Sclerosis conditions: Xeroderma Pigmentosum conditions: Cutis Laxa conditions: Albinism studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 650 type: ESTIMATED measure: Assessment of clinical outcomes of reproductive options sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Maastricht University Medical Center city: Maastricht state: Limburg zip: 6202AZ country: Netherlands lat: 50.84833 lon: 5.68889 hasResults: False

 nctId: NCT06330311 id: 20/551-EC briefTitle: Effectiveness of Whole-Body Vibration acronym: WBVibration overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-29 date: 2024-09-29 date: 2024-09-29 date: 2024-03-26 date: 2024-04-12 name: Universidad Complutense de Madrid class: OTHER name: Hospital Infantil Universitario Niño Jesús, Madrid, Spain briefSummary: Cerebral Palsy is the most common cause of severe physical disability in childhood and may present difficulties and limitations that will have an impact on their independence and integration in all social areas.

Within interventions aiming to manage CP Whole-Body Vibration (WBV) has shown some benefits such as reducing spasticity or improving strength and functionality of the lower limbs.

The aim of this study is to assess the effectiveness on motor function and spasticity of the lower limbs by adding an intervention with WBV to an evidence-based multimodal physiotherapy treatment in children with CP. conditions: Spastic Cerebral Palsy conditions: Physical Therapy Modalities conditions: Vibration; Exposure conditions: Lower Extremity Weakness, Spastic conditions: Muscle Spasticity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The participants will be randomly allocated to experimental or control group primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The principal investigator will be blinded to the randomization, patient assessment, and data analysis. whoMasked: INVESTIGATOR count: 30 type: ACTUAL name: Physiotherapy measure: GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions) measure: GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions) measure: GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions) measure: GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions) measure: Modified Ashworth Scale (MAS) measure: Modified Ashworth Scale (MAS) measure: Modified Ashworth Scale (MAS) measure: Modified Ashworth Scale (MAS) measure: 6 Minute Walking Test (6MWT) measure: 6 Minute Walking Test (6MWT) measure: 6 Minute Walking Test (6MWT) measure: 6 Minute Walking Test (6MWT) measure: Dynamometry measure: Dynamometry measure: Dynamometry measure: Dynamometry measure: Mini-Balance Evaluation System Test measure: Mini-Balance Evaluation System Test measure: Mini-Balance Evaluation System Test measure: Mini-Balance Evaluation System Test measure: Cerebral Palsy Quality of Life questionnaire (CP-QOL) measure: Cerebral Palsy Quality of Life questionnaire (CP-QOL) measure: Cerebral Palsy Quality of Life questionnaire (CP-QOL) sex: ALL minimumAge: 8 Years maximumAge: 14 Years stdAges: CHILD facility: María José Díaz Arribas city: Madrid zip: 28040 country: Spain lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06330298 id: 202000479 briefTitle: Improving Social Cognition and Social Behaviour in Various Brain Disorders acronym: T-ScEmo4ALL overallStatus: RECRUITING date: 2021-05-31 date: 2025-01-31 date: 2025-01-31 date: 2024-03-26 date: 2024-04-16 name: University Medical Center Groningen class: OTHER briefSummary: Impairments in aspects of social cognition are disorder-transcending: these have been demonstrated in various neurological disorders, such as traumatic brain injury (TBI), stroke, brain tumours (both low grade glioma's and meningioma's) and multiple sclerosis (MS). Social cognition involves processing of social information, in particular the abilities to perceive social signals, understand others and respond appropriately (Adolphs 2001). Crucial aspects of social cognition are the recognition of facial expressions of emotions, perspective taking (also referred to as mentalizing or Theory of Mind), and empathy. Impairments in social cognition can have a large negative impact on self-care, communication, social and professional functioning, and thus on quality of life of patients.

Recently, a first multi-faceted treatment for social cognitive impairments in TBI was developed and evaluated; T-ScEmo (Training Social Cognition and Emotion). T-ScEmo turned out to be effective in reducing social cognitive symptoms and improving daily life social functioning in this particular group, with effects lasting over time (Westerhof-Evers et al, 2017, 2019).

Unfortunately, up till now there are no evidence based, transdiagnostic treatment possibilities available for these impeding social cognition impairments in neurological patient groups, other than TBI. Therefore the aim of the present study is to investigate whether T-ScEmo is effective for social cognition disorders in patients with different neurological impairments, such as stroke (including subarachnoidal haemorrhage (SAH)), brain tumours, MS, infection (meningitis, encephalitis) and other. The secondary objective is to determine which patient related factors are of influence on treatment effectiveness. In short, hopefully this study can contribute to a treatment possibility for social cognition disorders for all patients with various neurological disorders.

It is expected that T-ScEmo will be effective for various neurological disorders, based on previous research of Westerhof-Evers et al. (2017, 2019). Since social cognition disorders within patients with traumatic brain injury do all have the same ethiology it is expected that the treatment will show the same effects for patients with various neurological disorders. Therefore it is expected that patients will improve on social cognition, social participation and quality of life and social behaviour, that these results will last over time. conditions: Stroke conditions: Multiple Sclerosis conditions: Brain Tumor studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Experimental condition T0, baseline measurement at point of inclusion (at least \> 6 months post-acute injuries) T1, post measurement within 2 weeks after treatment T2, follow-up measurement within 3 - 5 months after treatment

Waiting list condition T0, baseline measurement at point of inclusion (at least \> 6 months post-acute injuries) T1, post measurement within 3 months after T0 T2, follow-up measurement within 3 - 5 months after T1

TBI group T1, post measurement within 2 weeks after treatment T2, follow-up measurement within 3 - 5 months after treatment

The participating patients are randomly allocated into two groups: an experimental condition and a waiting list condition.

In addition, a group of patients with Traumatic Brain Injury will receive T-ScEmo following regular care. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The neuropsychologist who leads T1 and T2 measurements will be masked for the fact of which patient will be draw in which clinical condition (experimental group or control group), however this cannot be guaranteed since patients may talk about their experience. whoMasked: INVESTIGATOR count: 84 type: ESTIMATED name: Treatment social cognition and emotion regulation (T-ScEmo) measure: Change in social behaviour examined by proxy measure: Social cognition: Emotion recognition as assessed using the Eckman-60 faces test measure: Social cognition: Theory of Mind as assessed using the Happé cartoons test measure: Social cognition: Theory of Mind as assessed using the Faux Pas test measure: Social cognition: assessed using the Hailing Sentence Completion Test measure: Demographic information measure: Self-rated social behaviour as assessed using the Dysexecutive questionnaire Social Scales. measure: Self-rated social behaviour as assessed using the Interpersonal Reactivity Index measure: Self-rated social behaviour as assessed using The Dutch version of the BAFQ social scales measure: Proxy-rated social behaviour as assessed using the Interpersonal Reactivity Index measure: Proxy-rated social behaviour as assessed using the Socioemotional Dysfunction Scale measure: Proxy-rated social behaviour as assessed using the Dutch version of the BAFQ social scales measure: Alexithymia measure: Life satisfaction measure: (Social) participation as assessed using the Utrecht Scale for Evaluation of Rehabilitation measure: (Social) participation as assessed using the Impact on Participation and Autonomy scale measure: Mood and anxiety measure: Caregiving burden measure: Goal attainment measure: Executive functioning as assessed using the Controlled Oral Word Association Test measure: Executive functioning assessed using the Key Search Test measure: Verbal memory measure: Working memory measure: Language measure: Mental speed and attention as assessed using the Trail Making Test measure: Mental speed and attention as assessed using the Symbol Digit Modalities Test measure: Premorbid intelligence measure: Fatigue measure: Health limitations measure: Coping sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Deventer Hospital status: RECRUITING city: Deventer state: Overijssel zip: 7416SE country: Netherlands name: M.J.J. Gerritssen, dr. role: CONTACT lat: 52.255 lon: 6.16389 facility: University Medical Center Groningen status: RECRUITING city: Groningen zip: 9700VB country: Netherlands name: Amber Heegers, MSc. role: CONTACT phone: +3150 361 4666 email: a.heegers@umcg.nl lat: 53.21917 lon: 6.56667 hasResults: False

 nctId: NCT06330285 id: e learning pgme/cpet briefTitle: Comparison of E-Learning and Face-to-Face Learning in Cardiopulmonary Exercise Test Training overallStatus: NOT_YET_RECRUITING date: 2024-03-22 date: 2024-06-15 date: 2024-08-15 date: 2024-03-26 date: 2024-03-26 name: Kayseri City Hospital class: OTHER_GOV name: TC Erciyes University briefSummary: The main purpose of this study is to compare the effect of teaching Cardiopulmonary Exercise Test (CPET) via e-learning and face-to-face to doctors receiving postgraduate medical education (PGME). conditions: Exercise Test conditions: Learning studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 50 type: ESTIMATED name: e-learning name: face to face learning measure: Open-Ended Achievement Test measure: Adult Motivation Scale measure: Distance Education Attitude Scale in Lifelong Learning measure: Cognitive Flexibility Scale measure: State and Trait Anxiety Scale sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06330272 id: UCeuma briefTitle: Accuracy of Spectrophotometry in Hypomineralized Lesions Treated With CPP-ACPF Dental Mousse: Clinical Study acronym: ASHLTDMCS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-01 date: 2025-03 date: 2024-03-26 date: 2024-03-28 name: Meire Coelho Ferreira class: OTHER name: Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão briefSummary: MIH is a condition with considerable prevalence in the child population. This structural defect, represented by a change in the color of the enamel, can be accompanied by structural loss and great sensitivity. Remineralizing agents have been used to strengthen compromised enamel. The objective of the study will be to measure the accuracy of a spectrophotometer (VITA Easyshade V) in determining the mineralization of IMH lesions by a CPP-ACPF dental mousse. conditions: Molar Incisor Hypomineralization studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: MIH lesions will receive prophylaxis with pumice stone before application of CPP-ACPF-based dental foam (Tooth Mousse PlusTM, GC Corporation, Tokyo, Japan).

The application of Tooth Mousse Plus to the MIH lesion will be carried out under relative isolation and with the aid of a microbrush. The cream will remain on the surface for 1 minute. The application will be carried out once a week, for four consecutive weeks. primaryPurpose: TREATMENT masking: NONE count: 98 type: ESTIMATED name: Application of dental mousse based on CPP-ACPF measure: To measure the accuracy of a spectrophotometer (VITA Easyshade V) in determining the mineralization of IMH lesions by a CPP-ACPF dental mousse sex: ALL minimumAge: 7 Years maximumAge: 9 Years stdAges: CHILD facility: Josue Montello, Universidade Ceuma city: São Luis state: Maranhão zip: 65075-120 country: Brazil lat: -2.52972 lon: -44.30278 hasResults: False

 nctId: NCT06330259 id: new AMH assay briefTitle: Does the AMH Concentration Depend on the Menstrual Cycle? acronym: AMH overallStatus: COMPLETED date: 2017-07-01 date: 2018-06-30 date: 2019-12-31 date: 2024-03-26 date: 2024-04-01 name: University of Basel class: OTHER name: Roche Diagnostics briefSummary: During two none subsequent natural menstrual cycles healthy female participants will be subjected every second day to blood sampling and 3D-ultrasound examinations. Together with four other key hormones the concentration of AMH (anti-Muellerian Hormone) will be measured in the serum. conditions: Reproductive Sterility studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ACTUAL name: menstrual cycle monitoring measure: AMH Elecsys Assay measure: Effect of handling of the serum on measured AMH concentrations measure: 3D ultrasound of both ovaries sex: FEMALE minimumAge: 18 Years maximumAge: 39 Years stdAges: ADULT facility: Christian De Geyter city: Basel zip: 4031 country: Switzerland lat: 47.55839 lon: 7.57327 hasResults: False

 nctId: NCT06330246 id: IRB300005280 id: R01DK137784 type: NIH link: https://reporter.nih.gov/quickSearch/R01DK137784 briefTitle: O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease overallStatus: RECRUITING date: 2024-05-01 date: 2030-12-31 date: 2031-12-31 date: 2024-03-26 date: 2024-04-03 name: University of Alabama at Birmingham class: OTHER name: University of Texas Southwestern Medical Center name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The goal of this trial is to test if colonization with the gut bacteria Oxalobacter formigenes leads to a reduction in urinary oxalate excretion in patients with calcium oxalate kidney stone disease.

The study will recruit adult participants with a history of calcium oxalate kidney stones who are not colonized with Oxalobacter formigenes.

Participants will

* ingest fixed diets containing low and moderately high amounts of oxalate for 4 days at a time
* collect urine, blood and stool samples during the fixed diets
* ingest a preparation of live Oxalobacter formigenes to induce colonization with Oxalobacter formigenes conditions: Kidney Stone conditions: Kidney Calculi conditions: Urolithiasis conditions: Urolithiasis, Calcium Oxalate conditions: Nephrolithiasis conditions: Nephrolithiasis, Calcium Oxalate conditions: Oxalate Urolithiasis conditions: Oxaluria studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: BASIC_SCIENCE masking: NONE count: 40 type: ESTIMATED name: Low oxalate fixed diets pre-colonization name: Moderately high oxalate fixed diets pre-colonization name: Colonization with Oxalobacter formigenes name: Low oxalate fixed diets post-colonization name: Moderately high oxalate fixed diets post-colonization measure: Change in urinary oxalate excretion following colonization with Oxalobacter formigenes measure: Sustainability of colonization with Oxalobacter formigenes sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham status: RECRUITING city: Birmingham state: Alabama zip: 35294 country: United States name: Sonia Fargue, PhD role: CONTACT phone: 205-975-6932 email: sfargue@uab.edu name: Research Coordinator role: CONTACT phone: 2059345712 email: kidneystone@uabmc.edu name: Sonia Fargue, PhD role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 facility: UTSW status: RECRUITING city: Dallas state: Texas zip: 75390 country: United States name: Naim Maalouf, MD role: CONTACT email: Naim.Maalouf@UTSouthwestern.edu name: Esperanza Jackson role: CONTACT email: Esperanza.Jackson@UTSouthwestern.edu name: Naim Maalouf, MD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06330233 id: YJiang briefTitle: Different Amounts of Moxibustion in the Treatment of DPN: A Clinical RCT Study overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-04-07 date: 2026-12-31 date: 2024-03-26 date: 2024-03-26 name: Zhejiang Chinese Medical University class: OTHER_GOV name: The First Affiliated Hospital of Zhejiang Chinese Medical University briefSummary: This study is designed to provide the treatment plan for moxibustion for diabetic peripheral neuropathy (DPN) and provide a reference for clinical moxibustion for DPN. The patients will be randomly assigned to three clinical centers each center 44, then they will be distributed equally into 4 groups, which include the conventional treatment group and the moxibustion different minutes (5 minutes, 10 minutes, 15 minutes) per point group. The conventional treatment group will receive mecobalamin tablets and alpha-lipoic acid tablets for four weeks in conjunction with the patient's daily treatment (basal drug treatment for patients with combined hypertension and hyperlipidaemia). The frequency of moxibustion treatment is twice a week for 4 weeks. The outcomes were evaluated in the baseline period (the day before grouping), the treatment period (end of the 8th treatment) and the follow-up period (2 weeks after the end of treatment). The results of this study are expected to confirm the optimal amount of moxibustion for the treatment of diabetic peripheral neuralgia and to observe the efficacy of moxibustion in the treatment of diabetic peripheral neuralgia. It provides a reference for the clinical therapeutic operation standardization of moxibustion. conditions: Diabetic Peripheral Neuropathy conditions: Pain conditions: Moxibustion conditions: Randomized Controlled Trial studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 132 type: ESTIMATED name: Moxibustion measure: Electrophysiological examination of the tibial nerve of the lower limb measure: Electrophysiological examination of the peroneal nerve of the lower limb measure: Total clinical effectiveness measure: Toronto Clinical Scoring System measure: Visual Analogue Scale measure: Traditional Chinese Medicine Syndrome Score Scale measure: regional temperature testing measure: infrared thermography testing sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06330220 id: 2010-015-1161 briefTitle: Visual Function Change in Wet Age-related Macular Degeneration Patients With Better Baseline Visual Acuity overallStatus: COMPLETED date: 2021-02-10 date: 2022-02-28 date: 2022-02-28 date: 2024-03-26 date: 2024-03-26 name: Seoul National University Hospital class: OTHER briefSummary: Although the number of wet AMD patients with the better visual acuity is increasing, the visual improvement in patients with the better vision may not be so significant after anti-vascular endothelial growth factor (VEGF) treatments because of 'ceiling effect'. The aim of current study is to investigate the improvement of visual function after aflibercept treatments using microperimetry in wet AMD patients with the better baseline visual acuity (≥20/40). conditions: Age-Related Macular Degeneration studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ACTUAL name: Aflibercept Injection [Eylea] measure: Retinal sensitivity change after aflibercept treatment using microperimetry in wet age-related macular degeneration patients measure: The correlation of OCT and OCT angiography parameters with retinal sensitivity change measured by microperimetry sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital city: Seoul zip: 03080 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06330207 id: IRB202301471 id: K99DE031723 type: NIH link: https://reporter.nih.gov/quickSearch/K99DE031723 briefTitle: An Emergency Department (ED) Provider Centered Intervention for Non-Traumatic Dental Condition Management (NTDC) overallStatus: NOT_YET_RECRUITING date: 2025-08-01 date: 2027-02-01 date: 2027-08-01 date: 2024-03-26 date: 2024-03-26 name: University of Florida class: OTHER name: National Institute of Dental and Craniofacial Research (NIDCR) briefSummary: The overall objective of this proposal is to understand the barriers and facilitators to non-traumatic dental condition (NTDC) management in the emergency department (ED) through quantitative and qualitative methods. The first aim will determine the national variation in NTDC prescribing in the ED and subsequent ED/urgent care revisits and hospitalizations within 30-days of an index ED visit. Using national electronic health records and integrated claims datasets and a random effects model, we will identify factors associated with prescribing for NTDC and variation at the patient, provider, hospital and state levels. The second aim identifies ED providers' perceived barriers and facilitators to the management of NTDC in the ED. Using individual in depth interviews, ED providers (physicians, advanced practice providers) will identify the facilitators and barriers to management and prescribing for NTDC in the ED. conditions: Emergency Department Visit conditions: Odontalgia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 60 type: ESTIMATED name: Clinical decision support tool measure: Acceptability and feasibility measure: Prescribing behavior measure: Pilot trial outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06330194 id: AID-study briefTitle: Next Generation Advanced Insulin Delivery System in Adults With Diabetes and Advanced Renal Disease overallStatus: RECRUITING date: 2024-04-18 date: 2024-12-31 date: 2024-12-31 date: 2024-03-26 date: 2024-04-22 name: Steno Diabetes Center Copenhagen class: OTHER name: Rigshospitalet, Denmark briefSummary: The goal of this this randomized, clinical trial is to test an automated insulin delivery system (AID) in people with type 1 or type 2 diabetes who are on hemodialysis, peritoneal dialysis, or have advanced chronic kidney disease (CKD).

The main objective is:

• To test if the AID is superior in regulating blood sugar levels compared with usual care in patients with advanced renal disease

Secondary objectives are:

• To evaluate the impact on life quality, incidence of low blood sugar, and if the treatment is feasible in this population

Participants will be randomized to receive either eight weeks with the AID System (780G from Medtronic) or eight weeks of Control (usual care) with cross over at the end of the first eight weeks.

Researchers will compare blood sugar levels between the AID group and the Control group to determine if the AID system is superior in regulating blood sugar levels. conditions: Dialysis conditions: Chronic Kidney Disease conditions: Diabetes Mellitus, Type 2 conditions: Diabetes Mellitus, Type 1 conditions: Hemodialysis conditions: Peritoneal Dialysis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Design: Prospective, open-label, two-stage randomised-crossover study.

Population: Patients with type 1 or type 2 diabetes undergoing hemodialysis (n=5), peritoneal dialysis (n=5) or chronic kidney disease stage 3b to stage 5 (n=5).

Methods: Participants entering the study will have a four-to-six-week run-in phase with diabetes education. During the run-in phase three weeks of unblinded continous glucose monitoring (CGM) will be performed to assess baseline glucose levels.

All participants will be randomized to receive either eight weeks with an advanced insulin delivery (AID) System or eight weeks of control (usual care) with cross over at the end of the first eight weeks.

CGM study outcome data will be collected by identical methods, using unblinded-CGM devices, for participants in both intervention and control study arms. primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: 2nd Generation Automated Insulin Delivery (AID) system measure: Percent time in sensor glucose target range (3.9-10.0 mmol/L) measure: Proportion of time spent <2.8 mmol/L measure: Proportion of time spent <3.0 mmol/L measure: Proportion of time spent <3.3 mmol/L measure: Proportion of time spent <3.9 mmol/L measure: Proportion of time spent 3.9-7.8 measure: Proportion of time spent >10.0 mmol/L measure: Proportion of time spent >13.9 mmol/L measure: Proportion of time spent >16.7 mmol/L measure: Glucose variability (SD and coefficient of variation) measure: Mean glucose measure: HbA1c measure: Episodes of CGM time in < 3.0 mmol/L range lasting >15 minutes measure: Diabetic ketoacidosis og Hyperosmolar non-ketotic hyperglycemia measure: eGFR (estimated glomerular filtration rate) measure: Potassium pre-dialysis measure: Urine albumine-to-creatinine ratio measure: Actigraph Metrics for sleep architecture measure: Sleep diary measure: Proportion of time Automode is active measure: Diabetic ketoacidosis measure: Severe hypoglycemia measure: Serious Adverse Event measure: Unanticipated Serious Adverse Device Event measure: Satisfaction with diabetes treatment measure: Satisfaction with diabetes treatment measure: Fear of hypoglycaemia measure: Hypoglycaemia awareness measure: Diabetes distress measure: Sleep Quality measure: Cognitive function measure: Sarcopenia measure: Semi-structured interview measure: Health-related quality of life measure: Frailty sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tobias Bomholt status: RECRUITING city: Copenhagen zip: 2100 country: Denmark name: Tobias Bomholt, MD, PhD role: CONTACT phone: +4535457952 email: Tobias.bomholt@regionh.dk name: Christine Meyer Olesen, MD role: CONTACT phone: 21495144 email: clmolesen@gmail.com lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06330181 id: SC220178 id: HT9425-23-1-1019 type: OTHER_GRANT domain: Department of Depense briefTitle: Virtual Walking Therapy for Neuropathic Pain Following Incomplete Spinal Cord Injury overallStatus: RECRUITING date: 2024-03 date: 2026-01 date: 2027-01 date: 2024-03-26 date: 2024-03-26 name: Texas A&M University class: OTHER name: United States Department of Defense name: Immersive Experience Labs briefSummary: The purpose of this study is to determine if playing a virtual reality walking game can help improve neuropathic pain in adults with incomplete spinal cord injury. conditions: Spinal Cord Injuries conditions: Neuropathic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to one of two intervention arms. Both groups receive the same number of sessions, duration of sessions, and measures procured. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: VR Game 1 name: VR Game 2 measure: Change in Pain Intensity measure: Change in Pain Quality measure: Change in Pain Interference measure: Post treatment change measure: Change in mood measure: Change in quality of life measure: Neurological changes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Texas A&M University status: RECRUITING city: College Station state: Texas zip: 77843 country: United States name: Amanda Higgins, M.E.d role: CONTACT phone: 804-569-5965 email: sci@vrwalk.org name: Zina Trost, PhD role: PRINCIPAL_INVESTIGATOR lat: 30.62798 lon: -96.33441 hasResults: False

 nctId: NCT06330168 id: 36264PR573/2/24 briefTitle: Paravertebral Calcitonin in Thoracotomy overallStatus: RECRUITING date: 2024-03-28 date: 2025-04-10 date: 2025-04-10 date: 2024-03-26 date: 2024-03-28 name: Tanta University class: OTHER briefSummary: This prospective randomized double-blinded controlled study will be conducted to evaluate the effect of adding calcitonin to bupivacaine in thoracic paravertebral block for patients undergoing thoracotomy. conditions: Calcitonin conditions: Paravertebral conditions: Thoracotomy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: triple whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: bupivacaine-calcitonin-fentanyl name: Bupivacaine-fentanyl measure: morphine consumption measure: numerical rating scale scores measure: incidence of chronic pain measure: Side effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tanta University Hospitals status: RECRUITING city: Tanta state: Gharbiya zip: 31527 country: Egypt name: Osama M Rehab, MD role: CONTACT phone: 01095210806 email: osamarehab@med.tanta.edu.eg lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06330155 id: 2024-01-032 briefTitle: A Genetic Study for Alzheimer Dementia: Case-control Study overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2026-12-31 date: 2026-12-31 date: 2024-03-26 date: 2024-04-04 name: MinYoung Kim, MD, PhD class: OTHER briefSummary: The purpose of this study is to find out the difference in genetic test results between Alzheimer's dementia patients and healthy subjects.

The investigators want to identify genes that are importantly related to Alzheimer's dementia. conditions: Alzheimer Dementia (AD) studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 20 type: ESTIMATED measure: genetic analysis measure: Measurement of Korean version of mini-mental state examination (K-MMSE) measure: Measurement of Clinical Dementia Rating (CDR) measure: Measurement of Geriatric Depression Scale (GDSd) sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06330142 id: 2022-006 briefTitle: Hippotherapy Teenager-pediatric Radiotherapy acronym: T-QAP overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-15 date: 2025-12-15 date: 2024-03-26 date: 2024-03-26 name: Institut de cancérologie Strasbourg Europe class: OTHER briefSummary: This study proposes a horse-assisted therapy (HAT) approach to accompany children and young adults undergoing irradiation in the ICANS Radiotherapy Department.

The aim of this new approach is to improve quality of life and reduce anxiety in children and adolescents treated with radiotherapy. The impact of equine-assisted therapy on quality of life and anxiety disorders will be described prospectively between the start and end of irradiation in children and parents who agree to inclusion. conditions: Radiotherapy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 22 type: ESTIMATED name: Participation in 10 horse-assisted therapy sessions measure: Evolution of quality of life between the beginning and the end of horse-assisted therapy (HAT) in children (self-questionnaire) treated with radiotherapy measure: Improving children's quality of life between the start and end of irradiation (hetero-questionnaire) by HAT measure: Decrease anxiety disorders between the beginning - child version and end of irradiation in children (self-questionnaire) with HAT measure: Decrease anxiety disorders between the beginning - parents' version and end of irradiation in children (self-questionnaire) with HAT measure: Assessing the acute side effects of radiotherapy at the start and end of irradiation measure: Study the relevance of the various equestrian activities proposed as a strategy for improving care through the horse measure: Evaluate participant's expectations and satisfaction with their care measure: Assess the medical electroradiology technician's (MERT's) impression of the child's well-being during irradiation measure: Assessing the impact of HAT on the child during irradiation according to the MERT measure: Evaluate the rider's impression of the child's well-being of the child during HAT sessions measure: Assessing the impact of an alternative activity on parents' satisfaction with care sex: ALL minimumAge: 8 Years maximumAge: 17 Years stdAges: CHILD facility: Institut de Cancerologie Strasbourg Europe city: Strasbourg zip: 67033 country: France name: Valérie SARTORI role: CONTACT phone: 0368767223 email: v.sartori@icans.eu name: Manon VOEGELIN role: CONTACT phone: 0368767360 email: promotion-rc@icans.eu name: Laura BOINOT-FRITSCH role: PRINCIPAL_INVESTIGATOR name: Georges NOEL role: SUB_INVESTIGATOR name: Claire DOSSUN role: SUB_INVESTIGATOR lat: 48.58392 lon: 7.74553 hasResults: False

 nctId: NCT06330129 id: Pegasus01_Val briefTitle: Validity and Reliability of Trunk Strength Device acronym: PEGASUS overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-03-31 date: 2025-12-31 date: 2024-03-26 date: 2024-03-26 name: Schulthess Klinik class: OTHER name: Balgrist Campus AG briefSummary: The study aims to evaluate the accuracy and consistency of assessing trunk muscle strength using an isometric device (Pegasus, Leipzig, Germany). Thirty healthy volunteers will undergo maximal isometric strength testing with the device, repeated one week later to assess repeatability. Surface electrodes will measure muscle activation, while MRI scans will assess structural condition. conditions: Trunk Muscle Strength studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ESTIMATED name: CTT Pegasus measure: maximal isometric trunk muscle strength measure: MRI muscle morphology measure: Electromyography (EMG) activity sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT hasResults: False

 nctId: NCT06330116 id: 2023-05348-01 briefTitle: Different Forms of OMT as Methods for Reducing Snoring and Mild to Moderate Sleep Apnea acronym: SNORT overallStatus: ENROLLING_BY_INVITATION date: 2024-03-29 date: 2025-03-28 date: 2025-03-28 date: 2024-03-26 date: 2024-03-26 name: Region Västerbotten class: OTHER_GOV name: Interreg name: Umeå University briefSummary: Objective the present project aims to assess the impact of 1) oral screen training, group training, and the use of neuromuscular electrical training (NMES) as orofacial myofunctional therapy (OMT) methods for reducing the apnea-hypopnea index (AHI) among adults with mild to moderate sleep apnea and 2) if these different training methods can reduce snoring and affect the level of sleepiness and quality of life. Study design The study will use a prospective randomized open-blinded endpoint (PROBE) design with baseline measurements, intervention phase, and follow-up measurements.

Methods 141 consecutive adult subjects, 71 men and 70 women referred to hospital, due to symptoms of snoring and mild to moderate sleep apnea will be randomized, included, and examined at three different sites, Umeå(Sweden), Lund(Sweden) and Köge(Denmark) One hundred-five of them, 35 in each treatment group, will receive one of the three different forms of training and the final 36 persons serving as controls, age/AHI matched (18 in Köge resp Umeå). Participants in Umeå will be randomized to either training with IQoro or serving as controls. Participants in Köge will be randomized to either training with Exciteosa, group training, or controls.

The primary outcome is a change in AHI before and after three months of training with the different methods according to overnight ambulatory sleep apnea recordings.

The secondary outcomes are change in snoring frequency, sound level dB (A) according to a questionnaire, the Basic Nordic Sleep Questionnaire (BNSQ), daytime sleepiness using the Epworth Sleepiness Scale (ESS), change in quality of life using the short form -36 (SF-36) and muscle strength in tongue before and after treatment. conditions: Sleep Apnea, Obstructive conditions: Snoring studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 141 consecutive adult subjects, 71 men and 70 women, referred to hospital, due to symptoms of snoring and mild to moderate sleep apnea will be randomized, included, and examined at three different sights, Umeå(Sweden), Lund(Sweden) and Köge(Denmark) One hundred-five of them, 35 in each treatment group, will receive one of the 3 different forms of training and the final 36 persons serving as controls, age/AHI matched (18 in Köge resp Umeå). Patients in Umeå will be randomized to either training with IQoro or serving as controls. Patients in Köge will be randomized to either training with Exciteosa group training, or controls. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The study will use a prospective randomized open-blinded endpoint (PROBE) design with baseline measurements, intervention phase and follow-up measurements, and controls without intervention. The results are then analyzed and blinded to the evaluators. whoMasked: OUTCOMES_ASSESSOR count: 141 type: ESTIMATED name: IQoro name: eXciteosa name: Grouptraining measure: Apnea-hyponpnea index (AHI) measure: Questionnaries measure: Snoring measure: Tounge strenght sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zealand University Hospital city: Köge state: Sjaelland zip: 4600 country: Denmark lat: 55.45802 lon: 12.18214 facility: Skåne University Hospital city: Lund state: Skåne zip: 22100 country: Sweden lat: 55.70584 lon: 13.19321 facility: Region Västerbotten city: Umeå state: Västerbotten zip: 901 85 country: Sweden lat: 63.82842 lon: 20.25972 hasResults: False

 nctId: NCT06330103 id: RayongH briefTitle: Efficacy of AI EF Screening by Using Smartphone Application Recorded PLAX View Cardiac Ultrasound Video Clips overallStatus: COMPLETED date: 2023-05-01 date: 2023-07-31 date: 2023-07-31 date: 2024-03-26 date: 2024-03-26 name: Rayong Hospital class: OTHER name: Chulalongkorn University briefSummary: Assessing the Efficacy of Artificial Intelligence in Left Ventricular Function Screening Using Parasternal Long Axis View Cardiac Ultrasound Video Clips

ABSTRACT BACKGROUND: Echocardiography serves as a fundamental diagnostic procedure for managing heart failure patients. Data from Thailand's Ministry of Public Health reveals that there is a substantial patient population, with over 100,000 admissions annually due to this condition. Nevertheless, the widespread implementation of echocardiography in this patient group remains challenging, primarily due to limitations in specialist resources, particularly in rural community hospitals. Although modern community hospitals are equipped with ultrasound machines capable of basic cardiac assessment (e.g., parasternal long axis view), the demand for expert cardiologists remains a formidable obstacle to achieving comprehensive diagnostic capabilities. Leveraging the capabilities of Artificial Intelligence (AI) technology, proficient in the accurate prediction and processing of diverse healthcare data types, offers a promising for addressing this prevailing issue. This study is designed to assess the effectiveness of AI in evaluating cardiac performance from parasternal long axis view ultrasound video clips obtained via the smartphone application.

OBJECTIVES: To evaluate the effectiveness of artificial intelligence in screening cardiac function from parasternal long axis view cardiac ultrasound video clips obtained through the smartphone application. conditions: Heart Failure conditions: Heart Failure With Reduced Ejection Fraction conditions: Cardiac Failure conditions: Echocardiography conditions: Artificial Intelligence studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 923 samples that were evaluated for LVEF by certified cardiologists, 739 clips were used to train AI, while the remaining 184 clips were used to test if AI could process the results correctly. Artificial intelligence aims to classify cardiac function into three groups: Reduced EF, Mildly Reduced EF, and Preserved LV. primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 923 type: ACTUAL name: Easy EF measure: efficiency of AI in screening left ventricular cardiac function by use smartphone application sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Rayong Hospital city: Rayong zip: 066 country: Thailand lat: 12.68095 lon: 101.25798 hasResults: False

 nctId: NCT06330090 id: NL84688.091.23 id: 101040534 type: OTHER_GRANT domain: European Research Council briefTitle: COgnitive Dynamics in Early Childhood acronym: CODEC overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-12 date: 2027-12 date: 2024-03-26 date: 2024-03-26 name: Radboud University Medical Center class: OTHER briefSummary: The goal of this accelerated longitudinal observational cohort study is to advance our understanding of cognitive variability in children aged 7 to 10 at first measurement. The CODEC study aims to integrate experience sampling methods, longitudinal designs, deep phenotyping cohorts, and state-of-the-art statistical methodologies to investigate three core questions:

1. How does cognitive variability differ between individuals?
2. What are the neural, psychological, and environmental mechanisms that underlie cognitive variability?
3. What are the long-term consequences and outcomes associated with differences in cognitive variability? conditions: Cognitive Change studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED measure: Reaction times from the vocabulary cognitive task measure: Reaction times from the exploration cognitive task measure: Reaction times from the Working Memory cognitive task measure: Reaction times from the speed cognitive task measure: Reaction times from the fluid reasoning cognitive task measure: Mood score on smiley slider measure: Sleep score on smiley slider measure: MP-RAGE MRI sequence baseline measure: Functional MRI sequence of low time constraint reasoning task at baseline measure: gaze direction during reasoning task at baseline measure: pupil dilation during reasoning task at baseline measure: Naturalistic viewing fMRI at baseline measure: Naturalistic viewing fMRI at follow-up measure: Functional MRI sequence of high time constraint reasoning task at follow-up measure: gaze direction during reasoning task at baseline at follow-up measure: pupil dilation during reasoning task at baseline at follow-up measure: Functional MRI sequence of low time constraint reasoning task at follow-up measure: Sparse MP2-Rage MRI sequence baseline measure: Diffusion weighted imaging MRI sequence baseline measure: MP-RAGE MRI sequence follow up measure: Sparse MP2-Rage MRI sequence follow up measure: Diffusion weighted imaging MRI sequence follow up measure: Total score for Highly Sensitive Child scale at baseline measure: Total score for Strengths and difficulties questionnaire at baseline measure: Total score for BRIEF-2 questionnaire at baseline measure: Total score for BRIEF-2 questionnaire at follow-up measure: Total score for Strengths and difficulties questionnaire at follow-up measure: Total score for Mind Excessively Wandering Scale scale at baseline measure: Originality score for the Alternative Uses Tasks at baseline measure: Originality score for the Alternative Uses Tasks at follow-up measure: Total score for Parent-reported Mind Excessively Wandering Scale scale at baseline measure: Total score for Parent-reported Socio-demographic questionnaire at baseline measure: Total score for Parent-reported Socio-demographic questionnaire at follow-up measure: Total score for Mind Excessively Wandering Scale scale at follow-up measure: Total score for Parent-reported Mind Excessively Wandering Scale scale at follow-up measure: Total score for Highly Sensitive Child scale at follow-up measure: motivation rating for cognitive tasks measure: Decibel of background noise during cognitive testing measure: Academic school result baseline measure: Academic school result follow-up measure: Parent reaction times on cognitive battery at baseline measure: Parent reaction times on cognitive battery at follow-up sex: ALL minimumAge: 7 Years maximumAge: 13 Years stdAges: CHILD hasResults: False

 nctId: NCT06330077 id: APHP200027 id: 2021-003584-99 type: EUDRACT_NUMBER briefTitle: Ifenprodil as a ReMyelinating repurpOsed Drug in Multiple Sclerosis acronym: MODIF-MS overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-03 date: 2027-06 date: 2024-03-26 date: 2024-03-26 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Multiple sclerosis (MS) is the most frequently acquired demyelinating disease and the first cause of non-traumatic chronic disability in young adults. Major progress has been achieved in the treatment of MS through the development of therapies targeting the adaptative immune system, which drastically reduce the relapse rate, with various efficiency and safety profiles (Ontaneda, 2015). However, these drugs generally fail to prevent disability worsening along the disease course, and we are now assisting to a shift in therapeutic objectives from the development of new immune drugs towards the identification of therapeutic strategies that could prevent neurodegeneration by promoting myelin regeneration (Stangel, 2017; Stankoff, 2016), in order to prevent neurological disability in MS (Irvine and Blakemore, 2008; Patrikios, 2006; Duncan I, 2017, Bodini, 2016).

Among the first candidate compounds developed to promote remyelination was the anti Lingo1 antibody, which enhance remyelination (Mi, 2009). Medium and large throughput screening of drug libraries subsequently identified several chemical classes of compounds with strong promyelinating properties, such as the antifongic drug miconazole (Najm, 2015) or the muscarinic antagonist clemastine (Wei, 2014). A recent innovative trial has investigated the effect of clemastine, compared to placebo, in a small sample of subjects (25 patients per group) and showed that clemastine could significantly improve the optic nerve conduction speed which reflecting myelin integrity and functionality (Green, 2017).

Our preclinical research has allowed us to identify ifenprodil as a powerful drug to promote myelin repair in vitro and in vivo across species. In parallel our team recently pioneered and optimized a PET imaging approach for quantifying remyelination in the whole brain, that allowed to enhance the sensitivity to detect the myelin repair process, and showed that patients are characterized by heterogeneous profiles of spontaneous remyelination profiles that are closely linked to disability accrual (Bodini, 2016). conditions: Multiple Sclerosis conditions: Remitting Relapsing Multiple Sclerosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Ifenprodil name: Placebo measure: Change in P100 latency according to visual evoked potential. measure: Proportion of voxels within white matter lesions classified as remyelinating measure: Proportion of remyelinating voxels extracted in cortical regions from magnetization transfer imaging (MTR) acquisitions measure: Change in amplitude of P100 on to visual evoked potential measure: Change in retinal nerve fibre layer (RNFL) and ganglion cell complex (GCC) thickness on OCT measure: Change in blood concentration of NfL fragments measure: Change in the brain atrophy rate measure: The correlation between the change in the proportion of remyelinating voxels extracted in white matter lesions from [18F]florbetaben PET acquisitions measure: The comparison of the proportion of remyelinating voxels extracted in white matter lesions from [18F]florbetaben PET acquisitions measure: Incidence of adverse drug reactions sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Hôpital Neurologique Pierre WERTHEIMER - HCL city: Bron zip: 69677 country: France name: Françoise DURAND DUBIEF, MD role: CONTACT phone: 04 72 35 75 22 email: françoise.durand-dubief@chu-lyon.fr lat: 45.73333 lon: 4.91667 facility: Groupe Hospitalier Pitié Salpêtrière - APHP city: Paris zip: 75013 country: France name: Bruno STANKOFF, MD role: CONTACT email: bruno.stankoff@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06330064 id: DS7300-203 id: 2023-509632-26 type: OTHER domain: EU CTR briefTitle: A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXD) In Subjects With Recurrent Or Metastatic Solid Tumors overallStatus: RECRUITING date: 2024-04-10 date: 2026-12-01 date: 2028-07-01 date: 2024-03-26 date: 2024-04-16 name: Daiichi Sankyo class: INDUSTRY name: Merck Sharp & Dohme LLC briefSummary: This study is designed to assess the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC); hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric); non-squamous non-small cell lung cancer (NSCLC); and urothelial carcinoma (UC). conditions: Recurrent or Metastatic Solid Tumors studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 260 type: ESTIMATED name: Ifinatamab deruxtecan measure: Objective Response Rate (ORR) as Assessed by Investigator measure: Number of Dose-limiting Toxicities in the HCC Cohort measure: Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) measure: Duration of Response (DoR) measure: Progression-free Survival (PFS) measure: Disease Control Rate (DCR) measure: Overall Survival (OS) measure: Pharmacokinetic Parameter Maximum Concentration (CMax) for I DXd, total anti-B7-H3 antibody, and DXd measure: Pharmacokinetic Parameter Time to Reach Maximum Plasma Concentration (TMax) for I DXd, total anti-B7-H3 antibody, and DXd measure: Pharmacokinetic Parameter Half-life (t1/2) for I DXd, total anti-B7-H3 antibody, and DXd measure: Pharmacokinetic Parameter Minimum Concentration (Ctrough) for I DXd, total anti-B7-H3 antibody, and DXd measure: Pharmacokinetic Parameter Area Under the Curve (AUC) for I DXd, total anti-B7-H3 antibody, and DXd measure: Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) measure: Percentage of Participants Who Have Treatment-emergent ADA sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Alliance, Inc. status: RECRUITING city: Westbury state: New York zip: 11590 country: United States lat: 40.75566 lon: -73.58763 hasResults: False

 nctId: NCT06330051 id: KY 2023-184-02 briefTitle: The Improve Acute Reperfusion Treatment Quality for Ischemic Stroke Through Spatiotemporal Computing in China acronym: IMPROVE-II overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2025-03-18 date: 2025-04-20 date: 2024-03-26 date: 2024-03-26 name: Beijing Tiantan Hospital class: OTHER briefSummary: This study intends to construct the goal-oriented integrated intervention model for AIS in-hospital procedure through the spatiotemporal positioning and the P-D-C-A cycle for continuous improvement (FAST model). Then a multicenter, evaluator-blind, cluster-randomized controlled study aims to verify the validity and safety of this FAST model. conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: After 2 months of baseline information collection,10 hospitals will be seleted and then randomly assigned to the control and intervention groups according to hospital level and baseline DNT to reduce the imbalance between the two groups. We will not indicate to any hospital the grouping type of other hospitals. If the selected hospital is unable to complete the study for some reason during the operation, the hospital with conditions to carry out the replacement will be selected from the hospitals of the same region, the same level and the same scale. whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: improvement acute reperfusion treatment quality for stroke through spatiotemporal computing measure: The Door to Needle time (DNT) for intravenous thrombolytic therapy in eligible patients within 4.5 hours of onset. measure: The Door to Puncture time (DPT) for endovascular treatment within 6 hours of onset in eligible patients admitted to hospital within 4.5 hours of onset. measure: The rate of intravenous thrombolytic therapy in eligible patients within 4.5 hours of onset. measure: The rate of endovascular treatment within 6 hours of onset in eligible patients admitted to hospital within 4.5 hours of onset. measure: Incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours of receiving reperfusion therapy. measure: Proportion of patients with 90-day favorable functional outcome. measure: Proportion of patients with 90-day independent functional outcome. measure: in-hospital mortality measure: 90-day mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06330038 id: SMC 2024-01-065 briefTitle: Anesthesia and Non-small Cell Lung Cancer Recurrence acronym: GASTIVA overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-12-31 date: 2028-12-31 date: 2024-03-26 date: 2024-03-28 name: Samsung Medical Center class: OTHER name: Seoul National University Hospital name: Asan Medical Center name: Severance Hospital name: Seoul St. Mary's Hospital name: Korea University Guro Hospital name: DongGuk University name: Inha University Hospital name: Konkuk University Medical Center name: Ewha Womans University name: Chungnam National University Hospital name: University of Virginia name: Memorial Sloan Kettering Cancer Center name: Yale University name: Mayo Clinic name: University of Texas Southwestern Medical Center name: University Hospitals Coventry and Warwickshire NHS Trust name: Khon Kaen University name: King Chulalongkorn Memorial Hospital name: The Affiliated Hospital of Qingdao University name: Beijing Hospital name: All India Institute of Medical Sciences, New Delhi briefSummary: There has been ongoing debate about the relationship between cancer recurrence and anesthetic management. Therefore, the investigators will test the hypothesis that the recurrence free survival (RFS) after curative resection of NSCLC is higher in patient who received total intravenous anesthesia (TIVA) than volatile anesthetics in this multi-center randomized trials. conditions: Non-small Cell Lung Cancer conditions: Surgery conditions: Anesthesia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 5384 type: ESTIMATED name: Propofol name: Inhaled anesthetics measure: Recurrence free survival measure: Overall survival measure: Postoperative complications sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06330025 id: 69HCL23_1180 briefTitle: Exploring Food Rejection Dispositions as Potential Risk Factors for Undernutrition in Hospitalized Children Aged 2 to 8 acronym: MEDIALIME overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2025-05 date: 2024-03-26 date: 2024-03-26 name: Hospices Civils de Lyon class: OTHER briefSummary: Undernutrition affects over 30% of hospitalized children in France, with 10% severely malnourished yet only half of the cases are diagnosed. Undernutrition deteriorates children's health during hospital stays, weakening immunity and hindering recovery. Children suffering from acute malnutrition can stay in the hospital 45% longer than non-malnourished patients.

One of the primary causes of malnutrition is the reduction in children's food intake. Several researchers have emphasized that the young age of patients is associated with reduced food intake. For example, data on 923 children aged 1 day to 16 years indicates that patients under 8 years old are at a higher risk of undernutrition than older children.

The MEDIC project aims to investigate if increased food rejection dispositions contribute to reduced food intake in hospitalized children. Food rejections are typically observed between 2 and 8 years. Some children are more challenging and eat only a few different foods, while others try everything. Around the age of 2, children become more selective about the foods they consume. This is largely due to two common dispositions in young children: food neophobia and food pickiness. Food neophobia is defined as the reluctance to eat or even try foods that appear new, whereas food pickiness is defined as the rejection of a substantial number of familiar foods, including foods previously tasted. Both pickiness and neophobia have been associated with a significant reduction in food consumption (especially of vegetables), a decrease in food variety, and less enjoyment derived from food. A study showed that children aged 2 to 5 were twice as likely to be underweight if they were picky eaters.

Studies have shown that the socioeconomic status has a significant impact on food rejection in children. For instance, longitudinal studies reveal a higher proportion of picky eaters in low-income families. Parental education was also found to be inversely associated with children's food rejection levels.

The MEDIC project seeks to assess health inequalities by studying the impact of food rejection dispositions on the nutritional status of children in pediatric services. A qualitative study supports the notion that food rejection is heightened during the hospitalization: half of the parents of hospitalized children interviewed reported that foods accepted outside the hospital were rejected in the ward. Parents indicated that their child's food preferences were more limited, and they only alternated between a few foods after entering the hospital. According to the majority of interviewed nurses, children refuse any food other than that provided by parents.

The research hypotheses of the MEDIC project focus on understanding the moderating effects of food rejection dispositions and socioeconomic backgrounds on children's food intake during hospitalization. Two hypotheses are formulated: (H1) the pre-hospitalization food rejection levels predict the amount of food consumed during the hospital stay, and (H2) children from disadvantaged socioeconomic backgrounds are more likely to refuse food during their hospital stay than those from more advantaged backgrounds. To test these hypotheses, parents of children aged 2 to 8 will complete questionnaires on food rejection dispositions upon admission, and food consumption (in grams and calories) will be assessed through weighing and photographs of meal trays taken 48 hours (± 24 hours) post-admission. The project aims to shed light on the complexities of childhood malnutrition, addressing social inequalities and contributing valuable insights for interventions and public health policy. conditions: Undernutrition studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 102 type: ESTIMATED name: Children between 2 and 8 years, without medical treatments or pathologies impacting food intake and his parents measure: Grams of hospital meals consumed by the patients at lunch measure: Calories of hospital meals consumed by the patients at lunch, 48 hours after their admission to the hospital. sex: ALL minimumAge: 2 Years maximumAge: 8 Years stdAges: CHILD facility: Hôpital Femme Mère Enfant de Lyon city: Bron zip: 69677 country: France name: Noël PERETTI, MD role: CONTACT phone: +33 (0)4.72.35.70.50 email: noel.peretti@chu-lyon.fr lat: 45.73333 lon: 4.91667 hasResults: False

 nctId: NCT06330012 id: GeoMx_Breast briefTitle: The Resistance Mechanism of Trastuzumab Deruxtexan in HER2 Positive Breast Cancer Patients. overallStatus: RECRUITING date: 2024-03-18 date: 2025-01-15 date: 2027-12-31 date: 2024-03-26 date: 2024-03-26 name: Samsung Medical Center class: OTHER briefSummary: This study is the spatial transcriptomic approach for revealing the resistance mechanism of trastuzumab deruxtexan in HER2 positive breast cancer patients. conditions: HER2-positive Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 50 type: ESTIMATED name: GeoMx data analysis with clinical outcome measure: Spatial transcriptomic analysis sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ji-Yeon Kim status: RECRUITING city: Seoul zip: 06351 country: Korea, Republic of name: Ji-Yeon Kim role: CONTACT phone: 82-2-3410-3459 email: jyeon25@skku.edu name: MIRYOUNG HONG role: CONTACT phone: 82-2-2148-7147 email: ring7629@naver.com lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06329999 id: CMG-sAML-001 briefTitle: A Prospective, Multicenter, and Exploratory Study of CMGV in the Treatment of Recurrent Adult AML and MDS-EB-2/Elder AML overallStatus: RECRUITING date: 2024-02-03 date: 2025-12-31 date: 2027-12-31 date: 2024-03-26 date: 2024-03-26 name: Ruijin Hospital class: OTHER name: Huadong Hospital name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine name: Huashan Hospital name: Army Medical Center of PLA name: Sun Yat-sen University name: RenJi Hospital name: Shanghai Jiading District Central Hospital name: The Second Affiliated Hospital of Dalian Medical University name: First Hospital of China Medical University name: Dalian Municipal Central Hospital name: Shanghai Zhongshan Hospital name: Shanghai Pudong Hospital name: Shanghai Public Health Clinical Center name: Xuhui Central Hospital, Shanghai name: The Affiliated People's Hospital of Ningbo University name: Taizhou First People's Hospital name: Wenzhou People's Hospital briefSummary: The goal of this clinical trial\] is to evaluate mitoxantrone hydrochloride liposomes, subcutaneous injection of cytarabine and G-CSF combined with Venetoclax (CMG+Ven) in adult secondary acute myeloid leukemia and myelodysplastic syndrome with increased primordial cells type 2(MDS-IB2) or elderly acute myeloid leukemia\]. The main questions it aims to answer are:

* Evaluation of the efficacy
* Evaluation of the safety conditions: Recurrent Adult Acute Myeloid Leukemia conditions: Myelodysplastic Syndrome conditions: Adult Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 78 type: ESTIMATED name: CMGV measure: CRc measure: ORR measure: OS measure: RFS measure: MRD- measure: Adverse Event sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ruijin Hospital status: RECRUITING city: Shanghai state: Shanghai country: China name: xiaoqian Xu, Doctor role: CONTACT phone: 13816205940 email: Ellenxxq@qq.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06329986 id: SEDPTC20240109 briefTitle: Crossover RCT of TAMER Lenses in Myopia Control overallStatus: RECRUITING date: 2024-02-24 date: 2025-06 date: 2026-01 date: 2024-03-26 date: 2024-03-26 name: Shanghai Eye Disease Prevention and Treatment Center class: OTHER briefSummary: This study is a prospective, randomized, crossover clinical trial with a planned proposed enrollment of 120 Chinese male and female subjects aged 6-12 years without systemic or ocular diseases to follow up their cycloplegic equivalent spherical lens power and other relevant indices in order to determine the role of TAMER lenses in myopia control as compared to singlie vision lenses. conditions: Myopia conditions: Progressive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: TAMER Lens Spectacle name: SV lenses measure: Spherical Equivalent change measure: Axial Length change measure: Spherical Equivalent change sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Shanghai Eye Disease Prevention and Treatment Center status: RECRUITING city: Shanghai state: Shanghai zip: 200041 country: China name: Xiangui He role: CONTACT phone: 021-62982727-817 lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06329973 id: 2023-237 briefTitle: Fruquintinib in Combination With Sintilimab and CAPEOX as First-line Treatment for G/GEJ Cancer overallStatus: RECRUITING date: 2024-02-28 date: 2025-12-15 date: 2028-02-15 date: 2024-03-26 date: 2024-03-26 name: Henan Cancer Hospital class: OTHER_GOV briefSummary: Based on the current status and progress in the treatment of gastric cancer, our center prospectively designed a first-line comprehensive treatment plan for unresectable or postoperative recurrent advanced gastric/gastroesophageal conjoint adenocarcinoma, fruquintinib + sintilimab + oxaliplatin + Capecitabine (CAPEOX), which utilizes the tumor immunomodulation and vascular normalization effects of fruquintinib. While improving the effective perfusion of intravenous chemotherapy with CAPEOX regimen, further combining with PD-1 monoclonal antibody to regulate the immunosuppressive microenvironment and reactivate the anti-tumor immune response of the body. An exploratory dose-climbing trial was designed to evaluate the clinical efficacy and safety of fruquintinib in combination with Sintilimab and CAPEOX in clinical practice. At the same time, changes in genome, pathology and immune microenvironment of tumor-related tissues before and after treatment were observed, and molecular markers related to curative effect were screened to explore the molecular mechanism affecting the curative effect of combination therapy, and further enrichment of therapeutic advantage groups to improve the surgical conversion rate laid the foundation for future large-scale clinical studies conditions: Metastatic Gastroesophageal Junction Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: Fruquintinib in combination with Sintilimab and CAPEOX measure: Objective response rate measure: Maximum tolerated dose measure: Overall Survival measure: Progression Free Survival measure: Disease Control Rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henan Cancer Hospital status: RECRUITING city: Zhengzhou state: Henan zip: 450008 country: China name: Xiaobing Chen role: CONTACT phone: +8613937100233 lat: 34.75778 lon: 113.64861 hasResults: False

 nctId: NCT06329960 id: 2024PHB019-001(3) briefTitle: Dorsal Scapular Nerve Injection Combined With Muscle Needle Release overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-05-30 date: 2024-11-30 date: 2024-03-26 date: 2024-04-16 name: Peking University People's Hospital class: OTHER briefSummary: Ultrasound-guided perineural injection (PIT) of 5% dextrose (D5W) hydrodissection has been widely used in the treatment of peripheral entrapment neuropathies. However, there are few studies investigating the efficacy of PIT using D5W HD for dorsal scapular nerve (DSN) entrapment. Generally, the DSN entrapment causes the stiffness of the major and minor rhomboideus(2). In clinical practice, the investigators observed that ultrasound-guided PIT using D5W HD combined with needle release of major and minor rhomboideus significantly relieved the pain of scapular region. Therefore, the investigators aimed to evaluate the 6-month efficacy of this procedure for the participants with DSN entrapment. conditions: Dorsal Scapular Nerve Entrapment studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Ultrasound-guided injection combined with needle release measure: visual analogue scale (VAS) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jiaan Zhu city: Beijing country: China name: Jiaan Zhu role: CONTACT email: canzhujia@126.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06329947 id: HMPL-012-SPRING-P106 briefTitle: A Phase II Study of Surufatinib Combined With PD-L1 and mFOLFOX6 as Second-line Treatment for Advanced PRAD overallStatus: NOT_YET_RECRUITING date: 2024-03-22 date: 2025-01-01 date: 2026-09-30 date: 2024-03-26 date: 2024-03-26 name: Rui-hua Xu, MD, PhD class: OTHER briefSummary: To preliminarily evaluate whether there is a survival benefit of surufatinib in combination with Caralizumab and mFOLFOX6 in the second-line treatment of advanced pancreatic cancer, and to explore the feasibility of second-line and post-line treatment for advanced pancreatic cancer conditions: Advanced Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 37 type: ESTIMATED name: Surufatinib in combination with Caralizumab and mFOLFOX6 measure: objective response rate (ORR) measure: disease control rate (DCR) measure: Progression-Free Survival (PFS) measure: overall survival (OS) measure: quality of life (QoL) measure: adverse events (AE) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SunYat-senUniversity Cancer Center city: Guangzhou country: China lat: 23.11667 lon: 113.25 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-12-12 uploadDate: 2024-03-18T20:39 filename: Prot_000.pdf size: 1380851 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-12 uploadDate: 2024-03-18T20:39 filename: ICF_001.pdf size: 541718 hasResults: False

 nctId: NCT06329934 id: XXZY-003 briefTitle: Refined Nursing in Rehabilitation Training overallStatus: COMPLETED date: 2022-05-01 date: 2023-05-31 date: 2024-01-01 date: 2024-03-26 date: 2024-03-26 name: Xinxiang Central Hospital class: OTHER briefSummary: This study is to explore the clinical effect of refined nursing in rehabilitation training for patients with brain injury during the recovery period. Patients in the control group were provided with routine nursing intervention, while patients in the study group adopted a nursing mode based on the concept of refinement treatment. Comparison was made in terms of the Glasgow Coma Scale (GCS) score, cognitive function score, functional independence score, nursing satisfaction, and incidence of complications. conditions: Brain Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 96 type: ACTUAL name: Establishment of a hierarchical monitoring and management team name: Assessment of pressure injury name: Communication name: Intervention for pressure ulcer name: Rehabilitation training name: introduction of the current patient's condition to family members name: maintaining appropriate temperature and humidity in the ward name: careful observation of vital signs in patients measure: GCS scores measure: GCS scores measure: cognitive function scores measure: cognitive function scores measure: functional independence scores measure: functional independence scores measure: Newcastle Satisfaction with Nursing Scale (NSNS) measure: Newcastle Satisfaction with Nursing Scale (NSNS) measure: incidence of adverse reactions measure: incidence of adverse reactions sex: ALL minimumAge: 33 Years maximumAge: 43 Years stdAges: ADULT facility: Effect of Refined Nursing in Rehabilitation Training for Patients with Brain Injury During the Recovery Period: An Observational Study city: Xinxiang state: Henan zip: 453000 country: China lat: 35.19033 lon: 113.80151 hasResults: False

 nctId: NCT06329921 id: 232192 briefTitle: Inpatient Monitoring of Unfractionated Heparin overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-04 date: 2026-05 date: 2024-03-26 date: 2024-03-26 name: Vanderbilt University Medical Center class: OTHER briefSummary: Unfractionated heparin (UFH) is the most widely used intravenous (IV) anticoagulant for treating and preventing thromboembolic disease (e.g., blood clots ). UFH must be closely monitored and adjusted in the hospital. There are two assays used to monitor UFH: 1) the activated partial thromboplastin time (PTT) and 2) the chromogenic anti-factor Xa assay (anti-Xa). This study aims to compare PTT and anti-Xa methods for monitoring UFH in a pragmatic, randomized controlled trial to determine which helps patients reach a therapeutic anticoagulation range faster. conditions: Blood Clot conditions: Thrombosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study will be performed as a pragmatic, randomized controlled clinical trial with parallel group assignment. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 2000 type: ESTIMATED name: PTT protocol name: anti-Xa protocol measure: Time to therapeutic anticoagulation range measure: Measurements in therapeutic anticoagulation range measure: Coagulation laboratory measurements measure: New thrombotic events measure: New clinically relevant bleeding events measure: New coagulation events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vanderbilt University Medical Center city: Nashville state: Tennessee zip: 37232 country: United States name: Benjamin Tillman, MD role: CONTACT lat: 36.16589 lon: -86.78444 hasResults: False

 nctId: NCT06329908 id: TSLG-001 briefTitle: DC Combined With ICIs in the Treatment of Advanced Lung Cancer Resistant to ICIs overallStatus: RECRUITING date: 2023-09-27 date: 2024-09-30 date: 2026-10-31 date: 2024-03-26 date: 2024-03-26 name: Zhen-Yu Ding class: OTHER briefSummary: This is a single-center, single-arm, prospective clinical trial to investigate the safety and efficacy of Neo-DCVac combined with ICIs in the treatment of advanced lung cancer resistant to ICIs. conditions: Lung Cancer studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: single arm primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: LG002 measure: The safety of Neo-DCVac combined with ICIs. measure: The efficacy of Neo-DCVac combined with ICIs. measure: The efficacy of Neo-DCVac combined with ICIs. measure: Synergistic anti-tumor mechanism. sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital status: RECRUITING city: Chengdu state: Si Chuan zip: 610000 country: China name: Zhengyu Ding, MD role: CONTACT phone: 18980601957 email: dingzhenyu@scu.edu.cn name: Qing Li, MD role: CONTACT phone: 18702848178 email: liqing@scu.edu.cn lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06329895 id: 22252 briefTitle: A Study to Learn About How BAY2927088 Affects the Level of Dabigatran or Rosuvastatin in the Blood When These Drugs Are Taken Together in Healthy Participants overallStatus: RECRUITING date: 2024-03-25 date: 2024-05-23 date: 2024-05-23 date: 2024-03-26 date: 2024-04-19 name: Bayer class: INDUSTRY briefSummary: Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) mutations.

Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins, like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer.

In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations.

BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer.

Researchers think that BAY2927088 inhibits drug transporters such as P-gp (P-glycoprotein) and breast cancer resistance protein (BCRP). Drug transporters are proteins that help in the movement of certain drugs into, through, and out of the body's cells. Dabigatran is a drug used in the treatment of blood clots in a vein and rosuvastatin is a drug used in the treatment of high cholesterol in the blood.

The main purpose of this study is to find out how BAY2927088, taken as multiple doses, affects the levels of dabigatran and rosuvastatin in the blood of healthy participants. For this, researchers will measure the following for dabigatran and rosuvastatin, when given with and without BAY2927088:

* Area under the curve (AUC): a measure of the total amount of the drug in participants' blood over time
* Maximum observed concentration (Cmax): the highest amount of the drug in participants' blood

In this study, participants will take the following treatments:

* Dabigatran in the morning of Day 1 and 9.
* Rosuvastatin in the morning of Day 3 and 12.
* BAY2927088 two times a day in the morning and evening of Days 6 to 15.

Participants will be in this study for about 8 weeks with 3 visits to the study clinic.

Participants will visit the study clinic:

* at least once, 2 to 28 days before the treatment starts, to confirm they can take part in this study
* once on the day before the treatment starts and will stay in the clinic until Day 16 of the treatment
* once, 7 to 10 days after last dose of BAY2927088, for a health check-up

During the study, the doctors and their study team will:

* do physical examinations
* collect blood samples from the participants to measure the levels of dabigatran, rosuvastatin and of BAY2927088
* check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
* ask the participants questions about how they are feeling and what adverse events they are having

An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment. conditions: Advanced Non-small Cell Lung Cancer conditions: EGFR Mutation conditions: HER2 Mutation conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 15 type: ESTIMATED name: BAY2927088 name: Dabigatran etexilate name: Rosuvastatin measure: Cmax of unconjugated dabigatran when given with and without BAY2927088 measure: AUC of unconjugated dabigatran when given with and without BAY2927088 measure: Cmax of rosuvastatin when given with and without BAY2927088 measure: AUC of rosuvastatin when given with and without BAY2927088 measure: Number of participants with treatment-emergent adverse events (TEAEs) measure: Severity of TEAEs sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: PAREXEL International Early Phase Clinical Unit (London) status: RECRUITING city: Harrow zip: HA1 3UJ country: United Kingdom lat: 51.57142 lon: -0.33371 hasResults: False

 nctId: NCT06329882 id: 14789 briefTitle: Doxycycline in Type II Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-03-20 date: 2025-04-20 date: 2024-03-26 date: 2024-03-26 name: Mostafa Bahaa class: OTHER briefSummary: Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease characterized by hyperglycemia, weight loss, and cardio-metabolic complications. T2DM develops due to the progression of insulin resistance (IR), impairment of insulin insensitivity, and failure of the pancreatic β-cells to release sufficient amount of insulin in response to glucose burden conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: open label primaryPurpose: TREATMENT masking: NONE maskingDescription: open label count: 60 type: ESTIMATED name: Sitagliptin 100mg name: Doxycyclin measure: Change in glycemic profile measure: Change in glycemic profile sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06329869 id: 202401158MIFD briefTitle: Sacituzumab Govitecan for Advanced Esophageal Squamous Cell Carcinoma acronym: SG-ESCC overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-11 date: 2027-11 date: 2024-03-26 date: 2024-03-26 name: National Taiwan University Hospital class: OTHER name: Gilead Sciences briefSummary: The goal of this clinical trial is to investigate the efficacy and safety of sacituzumab govitecan in patients with advanced esophageal squamous cell carcinoma. conditions: Esophageal Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Sacituzumab govitecan measure: Overall objective response rates (ORR) measure: Overall survival (OS) measure: Progression-free survival (PFS) measure: Duration of response (DOR) measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] measure: Biomarkers-related endpoints sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06329856 id: 202301218RIND briefTitle: Exploring Indications and Practices of Administering Artificial Hydration to Terminal Cancer Patients in Taiwan overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2026-07 date: 2024-03-26 date: 2024-03-26 name: National Taiwan University Hospital class: OTHER briefSummary: Background: The issue of artificial hydration for terminal cancer patients is a classic ethical dilemma in palliative care. It is a common practice especially when patients are incapable of oral intake; however, there is a lack of research on indications and practices for the provision of artificial hydration to terminal cancer patients in Taiwan. The investigators aim to conduct a nationwide survey of palliative care physicians on their indications (general or specific), and practices of providing artificial hydration to terminal cancer patients. With that understanding of reasoning and clinical practice, the investigators would further establish an indigenous, evidence-based consensus guideline to serve as a reference for physicians in Taiwan.

Methods: The study is comprised of two parts. The first part is to conduct a nationwide survey of palliative and oncology care specialists with a questionnaire designed from literature reviews and principles of clinical ethics. After validation of the questionnaire, the investigators will e-mail it to members of the Taiwan Academy of Hospice Palliative Medicine and the Taiwan Society of Cancer Palliative Medicine. The primary outcome measure of the study is the indication and clinical practice of artificial hydration, and the secondary outcome is factors associated with the administration or withdrawal of hydration.

The second part is to establish a national consensus on clinical guidelines for administering artificial hydration, where the investigators will conduct a modified Delphi method for 6 rounds. Literature reviews will be first performed and 14 sessions of one-to-one interviews in Round 1 to develop a draft. Subsequent rounds comprise questionnaire surveys among all panelists, teleconferences and e-mail discussions among core members, and cancer patients/patients' family discussions. Statistical criteria include median and disagreement scores according to the Inter-Percentile Range Adjusted for Symmetry. Items voted for by 70% or more panelists will be selected and formalized into a consensus guideline.

Expected results: The investigators hypothesize that the indication to administer artificial hydration to the terminal cancer patient is multi-factorial and culturally based.

Conclusion: The establishment of a consensus guideline will help clinicians to make an appropriate decision from ethical, medical, cultural, and emotional factors and facilitate cancer patients to achieve a good quality of dying. conditions: Terminal Cancer conditions: Hospice conditions: Palliative Medicine studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 1270 type: ESTIMATED name: Administering of artificial hydration measure: Likert scale on alteration of administer artificial hydration to the terminal cancer patient and principles of clinical ethics measure: Distributive statistics measure: Disagreement score according to the Interpercentile Range Adjusted for Symmetry (IPRAS) for survey results sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06329843 id: Intermountain briefTitle: Intermountain Inpatient Bilirubin Decision Accuracy Study Using Smartphone-based Measurements by Picterus Jaundice Pro overallStatus: RECRUITING date: 2024-02-12 date: 2024-05 date: 2024-05 date: 2024-03-26 date: 2024-03-26 name: Picterus AS class: INDUSTRY name: Intermountain Medical Center briefSummary: The goal of this project is to evaluate the performance of Picterus Jaundice Pro in an American population, including preterm and term newborns and pre- and post- phototherapy. conditions: Neonatal Jaundice studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 500 type: ESTIMATED name: Picterus Jaundice Pro (JP) measure: Enable high qualitative estimation of bilirubin levels in the blood of term and preterm newborns undergoing phototherapy using Picterus JP. measure: Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies without phototherapy. measure: Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies without phototherapy. measure: Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies who have received phototherapy. measure: Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies who have received phototherapy. sex: ALL minimumAge: 12 Hours maximumAge: 192 Hours stdAges: CHILD facility: Intermountain Health status: RECRUITING city: Salt Lake City state: Utah zip: 84132 country: United States name: Timothy M Bahr, MS MD role: CONTACT phone: 801-602-6523 email: Tim.Bahr@imail.org name: Kimberlee W Lewis, MS RN role: CONTACT phone: 801.507.7675 email: [kimberlee.weaverlewis@imail.org lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06329830 id: 2023-GAR-001 briefTitle: 177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer acronym: LUNAAR overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2028-05 date: 2024-03-26 date: 2024-03-27 name: Rohan Garje class: OTHER name: Janssen Scientific Affairs, LLC briefSummary: The purpose of this research study is to test the safety and possible side effects of Lutetium-177 (177Lu)-Prostate-Specific Membrane Antigen (PSMA)-617 along with niraparib and abiraterone acetate plus prednisone when it is given to people diagnosed with metastatic castration-resistant prostate cancer (prostate cancer that has spread to other parts of the body and does not improve with hormonal therapies) at different dose levels. Once an optimal dose is selected, the researchers want to find out what how well these treatments work to improve survival and control the growth of the tumor. conditions: Metastatic Prostate Cancer conditions: Castration-resistant Prostate Cancer conditions: Metastatic Castration-resistant Prostate Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: 177Lu-PSMA-617 name: Niraparib abiraterone acetate name: Prednisone measure: Determination of the recommended phase 2 dose (RP2D) measure: Prostatic-specific antigen (PSA)-50 response rate measure: Radiographic progression-free survival (rPFS) measure: Overall survival (OS) measure: PSA-80 response rate measure: Duration of response (DOR) measure: Objective response rate (ORR) sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Miami Cancer Institute city: Miami state: Florida zip: 33176 country: United States name: Rohan Garje, M.D. role: CONTACT phone: 786-596-2000 email: rohan.garje@baptisthealth.net name: Leslie Castaneda role: CONTACT phone: (786) 596-2000 email: leslie.castaneda@baptisthealth.net lat: 25.77427 lon: -80.19366 hasResults: False

 nctId: NCT06329817 id: A/28/ER/532/23 briefTitle: Incidence of Regurgitation in Patients Undergoing Intubation in Semi-fowler v/s Supine Position overallStatus: RECRUITING date: 2024-03-15 date: 2024-08 date: 2024-09 date: 2024-03-26 date: 2024-03-26 name: Pak Emirates Military Hospital class: OTHER briefSummary: One of the most dreaded complication of general anaesthesia is aspiration of gastric contents after induction of general anaesthesia.Many endeavours and measures have been practiced to reduce the incidence of aspiration pneumonia.One such method is to intubate the patient in semi-fowler or supine posture.My study is aimed to find out safe and best position between these two after induction of general anaesthesia to prevent aspiration pneumonia. conditions: Inguinal Hernia Bilateral studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Incidence of regurgitation in two different position. measure: Prevention of aspiration pneumonia sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: PEMH status: RECRUITING city: Rawalpindi state: Punjab zip: 44000 country: Pakistan name: PEMH role: CONTACT phone: +923317055191 email: rabbiafatimasattar555@gmail.com lat: 33.6007 lon: 73.0679 hasResults: False

 nctId: NCT06329804 id: RM_01-11-21b briefTitle: The Dose Response Effect of Isometric Handgrip Training Frequency on Blood Pressure in Normotensive Individuals overallStatus: RECRUITING date: 2021-11-01 date: 2024-05-31 date: 2024-05-31 date: 2024-03-26 date: 2024-03-26 name: Swansea University class: OTHER name: National Taiwan Normal University briefSummary: It is estimated by WHO (2021) that 1.4 billion individuals across the globe have high blood pressure with only 14% of people managing these elevated levels. Simple and effective lifestyle strategies are required to help people improve their blood pressure and/or attenuate increases in blood pressure with ageing. Exercise is one possible strategy: in previous research, several different types of exercise have been shown to have effects on blood pressure (Blackwell et al., 2017). However, many individuals do not adhere to currently recommended levels of exercise (150 mins of moderate intensity exercise per week), due to a combination of the required time commitment, lack of motivation, and the associated levels of effort / exertion and discomfort (Korkiakangas et al 2009). Thus, there is a need to investigate alternative exercise interventions which will overcome these barriers but remain effective at improving blood pressure (Herrod, Lund, \& Phillips, 2021).

Low intensity isometric hand grip training (IHGT) has been shown to result in large decreases in rest-ing blood pressure in younger and older age groups, in both men and women, and in individuals with normal as well as elevated baseline blood pressure (Badrov et al, 2013; Bentley et al., 2018; Millar et al., 2014). In this research, IHGT has typically involved performing 4 x 2 IHGT holds at 30% of maximal voluntary contraction, 3 times a week, over a 4-8-week intervention (Millar et al, 2014). Interestingly, there are very few studies that have investigated the effect of changing different protocol parameters on the adaptations in blood pressure, and the minimal effective dose of IHGT is unknown. One important modifiable parameter is training frequency and it is unknown whether reducing the frequency of IHGT will reduce the efficacy for improving blood pressure. Therefore, the aim of this randomised controlled trial is to compare the effect of IHGT with a frequency of 2 or 4 sessions/week on resting blood pressure. conditions: Blood Pressure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 45 type: ESTIMATED name: Isometric Handgrip Exercise Training (IHGT) measure: Resting Systolic Blood Pressure measure: Resting Diastolic Blood Pressure measure: Resting Mean Arterial Blood Pressure measure: Ratings of perceived exertion measure: Affective Valence sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: National Taiwan Normal University status: RECRUITING city: Taipei country: Taiwan name: Yung-Chih Chen, PhD role: CONTACT lat: 25.04776 lon: 121.53185 facility: Swansea University status: RECRUITING city: Swansea country: United Kingdom name: Richard Metcalfe role: CONTACT phone: 01792205678 phoneExt: 4779 email: r.s.metcalfe@swansea.ac.uk lat: 51.62079 lon: -3.94323 hasResults: False

 nctId: NCT06329791 id: AZ202401 briefTitle: A Phase 3 Study to Evaluate AZR-MD-001 in Patients With Abnormal Meibomian Gland Function and Dry Eye Disease (DED) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2025-11 date: 2024-03-26 date: 2024-04-24 name: Azura Ophthalmics class: INDUSTRY name: ORA, Inc. briefSummary: This study is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study designed to evaluate the treatment of abnormal meibomian gland function and associated symptoms of DED using either AZR-MD-001 0.5% ophthalmic ointment or its vehicle. Study drug (either AZR-MD-001 or vehicle) will be dosed twice-weekly at bedtime for up to 12 months. conditions: Dry Eye Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 500 type: ESTIMATED name: AZR-MD-001 name: Vehicle measure: Change from baseline in Meibomian Glands Yielding Liquid Secretion measure: Change from baseline in Total Ocular Surface Disease Index Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Arizona Eye Center city: Chandler state: Arizona zip: 85225 country: United States name: Erin Fox role: CONTACT phone: 714-559-8435 email: michael.depenbusch@doctrials.com lat: 33.30616 lon: -111.84125 facility: Global Research Management, Inc city: Glendale state: California zip: 91204 country: United States name: Logi El-Harazi role: CONTACT email: logi@grmclinical.com lat: 34.14251 lon: -118.25508 facility: Eye Research Foundation city: Newport Beach state: California zip: 92663 country: United States name: Linda Wirta role: CONTACT email: linda.wirta@drwirta.com lat: 33.61891 lon: -117.92895 facility: Pankratz Eye Institute city: Columbus state: Indiana zip: 47203 country: United States name: Kristin Slevin role: CONTACT email: Kslevin@pankratzeye.com lat: 39.20144 lon: -85.92138 facility: The Eye Care Institute/Butchertown Clinical Trials city: Louisville state: Kentucky zip: 40206 country: United States name: Danielle Gulock role: CONTACT email: dgulock@eyecareinstitute.com lat: 38.25424 lon: -85.75941 facility: Ophthalmology Associates city: Saint Louis state: Missouri zip: 63131 country: United States name: Maggie Thompson role: CONTACT email: maggiethompson@eyecare-partners.com lat: 38.62727 lon: -90.19789 facility: NC Eye Associates city: Apex state: North Carolina zip: 27502 country: United States name: Ashley Cooper role: CONTACT email: acooper@nceyeassociates.com lat: 35.73265 lon: -78.85029 facility: Oculus Research, Inc. city: Garner state: North Carolina zip: 27529 country: United States lat: 35.71126 lon: -78.61417 facility: CORE city: Shelby state: North Carolina zip: 28150 country: United States name: Winnie Simmons role: CONTACT email: winniesimmons.core@gmail.com lat: 35.29235 lon: -81.53565 facility: Scott & Christie and Associates, PC city: Cranberry Township state: Pennsylvania zip: 16066 country: United States lat: 40.68496 lon: -80.10714 facility: Advancing Vision Research (AVR) - Goodlettsville city: Goodlettsville state: Tennessee zip: 37072 country: United States name: Megan Medlin role: CONTACT email: meganm@avrteam.com lat: 36.32311 lon: -86.71333 facility: Total Eye Care city: Memphis state: Tennessee zip: 38119 country: United States lat: 35.14953 lon: -90.04898 facility: Advancing Vision Research (AVR) - Smyrna city: Smyrna state: Tennessee zip: 37167 country: United States name: Megan Medlin role: CONTACT email: meganm@avrteam.com lat: 35.98284 lon: -86.5186 facility: Piedmont Eye Center city: Lynchburg state: Virginia zip: 24502 country: United States name: Jennifer Frederick role: CONTACT email: jfrederick@piedmonteye.com lat: 37.41375 lon: -79.14225 hasResults: False

 nctId: NCT06329778 id: 50884b briefTitle: Home-Based Child Care Toolkit for Nurturing School-Age Children Study overallStatus: RECRUITING date: 2024-03-15 date: 2024-08-31 date: 2024-10-27 date: 2024-03-26 date: 2024-03-26 name: Mathematica Policy Research, Inc. class: OTHER name: Department of Health and Human Services briefSummary: The goal of this observational study is to build psychometric evidence for the Home-Based Child Care Toolkit for Nurturing School-Age Children (HBCC-NSAC Toolkit) provider questionnaire. The main objectives of the study are to: 1) assess the reliability of the HBCC-NSAC Toolkit provider questionnaire, 2) assess the evidence for its validity compared to other existing measures of HBCC quality, and 3) examine invariance across subgroups (that is, look for the absence of any differential item functioning \[DIF\]). HBCC provider participants will complete a questionnaire in the HBCC-NSAC Toolkit. A subset of providers will also participate in an observation of their child care setting. Parents or guardians of children receiving care from HBCC providers will complete a survey. conditions: Child Development studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 316 type: ESTIMATED measure: The Home-Based Child Care Toolkit for Nurturing School-Age Children provider questionnaire measure: Emlen Scales measure: Multicultural Teaching Competency Scale measure: Family Child Care Program Quality Assessment (FCC PQA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mathematica Policy Research status: RECRUITING city: Washington state: District of Columbia zip: 20002 country: United States name: Ashley Kopack Klein role: CONTACT phone: 202-484-9220 email: lakopackklein@mathematica-mpr.com lat: 38.89511 lon: -77.03637 hasResults: False

 nctId: NCT06329765 id: HR- 4380 briefTitle: CUped: An Approach to Motor Recovery Post-Stroke, Not Compensation overallStatus: RECRUITING date: 2023-08-07 date: 2025-04-04 date: 2025-04-04 date: 2024-03-26 date: 2024-03-26 name: Marquette University class: OTHER name: Medical College of Wisconsin briefSummary: The goal of lower limb rehabilitation after stroke is recovery of independent walking at home and in the community. Few stroke survivors achieve this goal. Suboptimal outcomes are due to the serious and intransigent nature of movement impairments caused by stroke and the scarcity of feasible and effective therapies that restore movement lost to stroke. Our team has developed a novel exercise intervention called CUped (pronounced cupid, like the Roman god) to address barriers to recovery and improve walking after stroke. CUped is so called because it compels use of the paretic limb during a movement that resembles pedaling. This project will examine safety, acceptability, and tolerance to CUped, characterize its therapeutic effects, and identify dose-response relationships. Results will provide preliminary data for an R01 to support a randomized controlled trial (RCT). CUped is designed to help stroke survivors recover lower limb movement lost to stroke, thereby improving walking. It is intended to be used as an adjunct to gait training. CUped uses a robotic technology that eliminates compensatory movements that interfere with recovery, compels use of the paretic lower limb, and targets 3 key movement impairments caused by stroke: decreased muscle output from the paretic limb, inappropriate paretic muscle timing, and abnormal interlimb coordination. Exercise is done in sitting which enables high repetition practice. Like walking, CUped requires continuous, reciprocal use of both lower limbs; effects are likely to transfer to walking. The risk-reward profile of this proposal is ideal for an R21, which is an NIH funding opportunity intended to encourage exploratory/developmental research by providing support for the early and conceptual stages of project development. CUped is a novel therapy grounded in a physiologic premise and based on prior observations from our laboratory. The investigators have pilot data suggesting that CUped fulfills its design specifications, and this study will be the first to test its therapeutic effects. In this Stage 1 rehabilitation trial, The investigators will support or quickly refute the hypothesis that CUped is safe, acceptable, and capable of eliciting a therapeutic response in stroke survivors. The investigators will also examine tolerance to CUped and dose-response effects. If our hypotheses are supported, the investigators will be poised to run an RCT to isolate the effects of CUped and compare them to standard care. Future work will investigate physiologic mechanisms underlying the effects of CUped. conditions: Stroke conditions: Hemiplegia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single group pretest-posttest primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Exercise with CUped - a motor-assisted, split crank pedaling device and undergo 50 m of gait training. measure: Paretic limb use in walking measure: Paretic limb use in pedaling measure: Interlimb coordination in walking measure: Interlimb coordination in pedaling measure: Motorized intervention during pedaling split-crank (i.e., bilateral uncoupled) pedaling measure: Absences measure: Adverse events measure: Muscle activity - timing measure: Muscle activity - amplitude measure: Physiological response to exercise - Blood pressure measure: Physiological response to exercise - Heart rate measure: Physiological response to exercise - Rate of perceived exertion sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marquette University status: RECRUITING city: Milwaukee state: Wisconsin zip: 53201 country: United States name: SHEILA M SCHINDLER-IVENS, PhD role: CONTACT phone: 414-288-7282 email: sheila.schindler-ivens@marquette.edu lat: 43.0389 lon: -87.90647 hasResults: False

 nctId: NCT06329752 id: Not available yet briefTitle: Sciatic Nerve Block for Ankle and Leg Fracture Manipulation in the Emergency Department acronym: AnkleMan overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-06 date: 2024-03-26 date: 2024-03-26 name: IRCCS Policlinico S. Matteo class: OTHER briefSummary: The goal of this feasibility clinical trial is to assess the acceptability of ultrasound-guided sciatic nerve block when performed at Emergency Departments for manipulation and temporary stabilization of distal leg and ankle fractures.

The trial aims to assess:

* The acceptability of sciatic nerve block
* The technical feasibility of sciatic nerve block
* The technical success of sciatic nerve block
* The analgesic efficacy of sciatic nerve block

In addition to that, this study aims to

* Describe patient-reported and physician-reported satisfaction
* Assess the Adverse Event rate at 48 hours post intervention conditions: Ankle Fractures conditions: Leg Fracture studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Interventional, single-arm, feasibility trial primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Ultrasound-guided Sciatic Nerve block (20 mL of 2% Lidocaine) measure: To assess the technical feasibility of ultrasound-guided sciatic nerve block when performed at Emergency Departments for manipulation and temporary stabilization of distal leg and ankle fractures. measure: Technical success of US-guided sciatic nerve block measure: Analgesic efficacy of US-guided sciatic nerve block measure: Patient-reported and physician-reported satisfaction measure: Safety Endpoint sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emergency Department, IRCCS Fondazione Policlinico San Matteo city: Pavia zip: 27100 country: Italy name: Santi Di Pietro role: CONTACT phone: 3463153244 email: santi.dipietro@unipv.it lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06329739 id: NeuroPsico_Dopa&PD briefTitle: Genetics in Parkinson's Disease: Behavioral and Cognitive Outcomes overallStatus: RECRUITING date: 2021-12-14 date: 2031-12-14 date: 2031-12-14 date: 2024-03-26 date: 2024-03-26 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: The genetic landscape of Parkinson's disease (PD) is characterised by rare high penetrance pathogenic variants causing familial disease, genetic risk factor variants driving PD risk in a significant minority in PD cases and high frequency, low penetrance variants, which contribute a small increase of the risk of developing sporadic PD. This knowledge has the potential to have a major impact in the clinical care of people with PD.

The goal of this observational study is to evaluate the impact of genetic mutation on behavior and cognition in PD patients.

Patients will be assessed over time using test, questionnaire and standardised clinica scales. An initial assessment and annual follow-up assessments will be carried out for 5 years.

Researchers will compare data collected from patients with genetic mutation versus patients without mutation. conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 68 type: ESTIMATED name: Clinical examinations and clinical scales administration measure: Montreal Cognitive Assessment measure: Beck Depression Inventory measure: State-Trait Anxiety Inventory measure: Questionnaire for Impulsive-Compulsive Disorders in Parkinson measure: Pittsburgh Sleep Quality Index measure: Parkinson's Disease Questionnaire-8 measure: Minnesota Multiphasic Personality Inventory 2-RF sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: RECRUITING city: Milan zip: 20122 country: Italy name: Francesca Mameli role: CONTACT phone: 0255033621 email: francesca.mameli@policlinico.mi.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06329726 id: NeuroPsico_DBS&PD briefTitle: Long-Term Behavioral and Cognitive Outcomes of Deep Brain Stimulation in Patients With Parkinson's Disease overallStatus: RECRUITING date: 2021-12-13 date: 2031-12-15 date: 2032-12-15 date: 2024-03-26 date: 2024-03-26 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: The goal of this observational study is to evaluate the long-term effect of DBS-STN on cognitive and behavioral outcomes in Parkinson's disease (PD) patients.

PD patients will be assessed over time using tests, questionnaires and standardized clinical scales. An initial assessment (T0) and annual follow-up assessments will be carried out for 5 years.

Researchers will compare data collected from patients with DBS versus patients with best medical therapy. conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 52 type: ESTIMATED name: Clinical examinations and clinical scales administration measure: Long-term characterization of DBS-STN on cognitive outcomes measure: Beck Depression Inventory measure: State-Trait Anxiety Inventory measure: Questionnaire for Impulsive-Compulsive Disorders in Parkinson measure: Pittsburgh Sleep Quality Index measure: Parkinson's Disease Questionnaire-8 measure: Minnesota Multiphasic Personality Inventory 2-RF sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: RECRUITING city: Milan state: Lombardia zip: 20135 country: Italy name: Eleonora Zirone, Dr role: CONTACT phone: 0255038671 phoneExt: 0039 email: eleonora.zirone@policlinico.mi.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06329713 id: 2024-03/11 briefTitle: Effect of Auto-Bolus Interval on Analgesic Quality During Labor Analgesia With Dural Puncture Epidural overallStatus: RECRUITING date: 2024-03-15 date: 2025-03-01 date: 2025-08-01 date: 2024-03-26 date: 2024-04-02 name: Ataturk University class: OTHER briefSummary: It is aimed in this study to compare the effect of changing the interval time for programmed auto boluses of local anaesthetics on the total anesthetic consumption and quality of labor analgesia with dural puncture epidural technique. conditions: Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Group I: 30 Min Interval Time name: Group II: 60 Min Interval Time measure: Difference between total local anaesthetic consumption sex: FEMALE minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: Atatürk University status: RECRUITING city: Erzurum country: Turkey name: Ayşenur Dostbil role: CONTACT phone: +905333677796 email: adostbil@hotmail.com lat: 39.90861 lon: 41.27694 hasResults: False

 nctId: NCT06329700 id: ParSparInLivAtrophy briefTitle: Parenchymal Sparing Hepatectomy in Post-chemotherapy Liver Atrophy overallStatus: COMPLETED date: 2010-05-01 date: 2019-12-31 date: 2022-06-30 date: 2024-03-26 date: 2024-03-26 name: Azienda Ospedaliero Universitaria Maggiore della Carita class: OTHER briefSummary: Major hepatectomy in patients with colorectal liver metastases (CLM) and post-chemotherapy liver atrophy is associated with increased complications. Whether the performance of parenchymal-sparing hepatectomy (PSH) in those patients can be safer is unknown. The aim of this study was to assess the clinical impact of post-chemotherapy liver atrophy on patients undergoing PSH for CLM. For this purpose, the occurrence of liver atrophy was recorded and then computed against the occurrence of postoperative morbidity and mortality. conditions: Colorectal Cancer Stage IV studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 74 type: ACTUAL name: Hepatectomy measure: Postoperative complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06329687 id: OPP-010 briefTitle: A Study Evaluating the Safety of the Nasal Pump overallStatus: TERMINATED date: 2024-02-21 date: 2024-02-28 date: 2024-02-28 date: 2024-03-26 date: 2024-04-18 name: Oyster Point Pharma, Inc. class: INDUSTRY briefSummary: The objective of this study is to determine the safety of the Tyrvaya nasal pump. conditions: Dry Eye conditions: Kerato Conjunctivitis Sicca studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ACTUAL name: Tyrvaya Nasal Pump measure: Incidence of Adverse Events measure: Tear Film Break up Time measure: Eye Dryness Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: United States, California city: Newport Beach state: California zip: 92663 country: United States lat: 33.61891 lon: -117.92895 hasResults: False

 nctId: NCT06329674 id: 20DM30203 briefTitle: Efficacy and Safety of AJU-A51 in Type 2 Diabetes Mellitus Patients overallStatus: COMPLETED date: 2021-04-27 date: 2022-12-01 date: 2023-06-13 date: 2024-03-26 date: 2024-03-26 name: AJU Pharm Co., Ltd. class: INDUSTRY briefSummary: A multicenter, randomized, double-blind, parallel group, placebo-controlled, phase 3 study to evaluate the efficacy and safety of the combination of A51R3 and AJU-A51 compared with the combination of A51R3 and A51R2 in patients with Type 2 diabetes mellitus who have inadequate glycemic control with the combination of A51R3 and A51R2 conditions: Type2 Diabetes studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 235 type: ACTUAL name: AJU-A51 name: A51R2 name: A51R3 name: AJU-A51 Placebo name: A51R2 Placebo measure: Changes in HbA1c sex: ALL minimumAge: 19 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Asan Medical Center city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06329661 id: CYS-007 briefTitle: A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-11-30 date: 2025-12-31 date: 2024-03-26 date: 2024-03-28 name: Novaliq GmbH class: INDUSTRY briefSummary: The objective of this trial is to evaluate the effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell health in comparison to a hypotonic saline solution in subjects with Dry Eye Disease (DED) conditions: Dry Eye Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Cyclosporine ophthalmic solution, 0.1% (VEVYE) name: Saline solution, 0.6% measure: Change from baseline in corneal ECD sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06329648 id: DECIDE briefTitle: Distributed Learning of Edic and CardIac Dose Effects in Lung Cancer acronym: DECIDE overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-31 date: 2028-06-01 date: 2024-03-26 date: 2024-03-26 name: The Netherlands Cancer Institute class: OTHER briefSummary: Cardiac dose was not a major concern in lung radiotherapy patients until the results of the RTOG (Radiation Therapy Oncology Group) 0617 trial, which showed an association between cardiac dose and survival. Since then, many papers have studied the association between cardiac (substructure) dose and either survival or cardiac toxicity. Ideally, cardiac toxicity would be separated from survival. However, scoring cardiac toxicity prospectively was not standard practice, and retrospective scoring is challenging because of the overlap of cardiac toxicity symptoms and lung cancer (treatment) symptoms. Therefore in real world cohorts, cardiac toxicity is usually not scored properly and most larger studies pragmatically consider overall survival as primary endpoint, and the relation between cardiac dose and cardiac toxicity is not well established for lung cancer patients.

Cardiac toxicity might not be the only factor in decreased survival; toxicity of the immune system might be a competing risk or a major contributing factor, where dose to the heart is a surrogate for dose to blood. Dose to the immune system is defined as EDIC (Effective Dose to circulating Immune Cells), comprising heart dose, lung dose and body dose combined. As EDIC dose and cardiac dose partly overlap, a large cohort with substantial variation will be required to disentangle the two effects. Such vast amounts of routine care data are immediately available in many radiotherapy centers all over the world. The problem we face is not the lack of routine care data, but making such data available for analysis. DECIDE adopts a federated learning approach, which implies that data does not have to be centralized within a single institution to be fit for use. We aim to include an unprecedentedly large-scale cohort of 20,000 patients.

In this proposal, we need to add on scientific and technological innovations that exploit the existing federated learning framework to scale up to supporting \>25 simultaneously connected partners. We will be training (generalized) linear epidemiological models as well as new computer vision-based models for outcome predictions. As cause-specific survival (cardiac toxicity or immune toxicity) is unavailable or unreliable in major studies, we will use the more pragmatic endpoint of survival. By elucidating the clinical contributions of whole heart dose, cardiac substructure dose and EDIC dose in combination with known clinical risk factors, the desired impact is to change clinical practice for lung cancer radiotherapy and improve survival. conditions: NSCLC studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 20000 type: ESTIMATED measure: Optimize EDIC dose measure: cardiac toxicity sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06329635 id: 2023070K briefTitle: Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-IT Trial overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-03-26 date: 2024-03-26 name: The Affiliated Hospital Of Guizhou Medical University class: OTHER briefSummary: To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage. conditions: Aneurysmal Subarachnoid Hemorrhage conditions: Vasospasm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The assigned "intervention" will be performed only by a separate unblinded dedicated physician who signs the confidential agreement. The attending/investigating physician and patient are blinded to the intervention assignment. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 396 type: ESTIMATED name: Intrathecal Nicardipine name: No intervention measure: Dichotomized Modified Rankin Scale (mRS) 0-2 vs 3-6 measure: Extended Glasgow Outcome Score (GOS-E). measure: Modified Rankin Scale ordinal shift with mRS 5 and 6 combined measure: Dichotomized Modified Rankin Scale (mRS) 0-3 vs 4-6 measure: Hamilton Depression Rating Scale (HAM-D) score measure: Hamilton Anxiety Rating Scale (HAM-A) score measure: Mini-Mental State Examination (MMSE) score measure: Montreal Cognitive Assessment (MoCA) scale score measure: Change of National Institutes of Health Stroke Scale (NIHSS) score measure: Cerebrospinal fluid shunt surgery rate measure: Overall mortality rate measure: Rate of CSF infection measure: Rate of any type of new intracranial hemorrhage. measure: Adverse Event measure: Serious Adverse Event sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06329622 id: KY2023-972 briefTitle: Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-06-30 date: 2026-06-30 date: 2024-03-26 date: 2024-04-17 name: Huashan Hospital class: OTHER briefSummary: The investigators hypothesize that Ketosteril can improve sarcopenia in patients with renal disease without increasing the burden on the kidneys and causing deterioration of renal function. Therefore, this study intends to take patients with CKD stage 3-4 and sarcopenia as the research object, give Ketosteril intervention or not to patients on the base of low-protein diet, and clarify the clinical benefits of Ketosteril prescription for improving sarcopenia in patients with CKD. conditions: Chronic Kidney Disease conditions: Sarcopenia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 58 type: ESTIMATED name: low-protein diet + Ketosteril name: low-protein diet measure: skeletal muscle mass index (SMI) measure: changes in eGFR(ml/min/1.73m2) measure: serum albumin(g/l) measure: grip strength(kg) measure: BMI(kg/m2) measure: 6m walking speed(s) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Nephrology, Huashan hospital city: Shanghai zip: 200040 country: China name: Mengjing Wang role: CONTACT phone: +8613764676029 email: fiyona27@126.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06329609 id: ClA-333 briefTitle: Airvo 3 Respiratory Rate Validation Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2024-10 date: 2024-03-26 date: 2024-03-26 name: Fisher and Paykel Healthcare class: INDUSTRY briefSummary: This is a clinical performance testing to validate the accuracy of the Airvo 3 device with respiratory rate algorithm manufactured by Fisher \& Paykel Healthcare for continuous respiratory rate monitoring. conditions: COPD conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: Airvo 3 with respiratory rate algorithm measure: Respiratory rate measure: Respiratory rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Element Boulder city: Louisville state: Colorado zip: 80027 country: United States name: Monica Rabanal, MSc, BSN role: CONTACT email: monica.rabanal@element.com name: Blair Holman, MS role: CONTACT phone: +1 651 379 5549 email: Blair.Holman@element.com name: Monica Rabanal, MSc, BSN role: PRINCIPAL_INVESTIGATOR lat: 39.97776 lon: -105.13193 hasResults: False

 nctId: NCT06329596 id: H-55146 id: D43TW012274 type: NIH link: https://reporter.nih.gov/quickSearch/D43TW012274 briefTitle: Microbiome Alterations With Xylitol (MAX) in Pregnancy acronym: MAX overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-03-31 date: 2026-03-31 date: 2024-03-26 date: 2024-04-19 name: Baylor College of Medicine class: OTHER name: Fogarty International Center of the National Institute of Health name: University of Washington name: Baylor College of Medicine Children's Foundation Malawi briefSummary: The purpose of this study is to understand if chewing xylitol-gum initiated before 20 weeks of pregnancy and continued until delivery affects the bacteria that are found in the oral and vaginal cavities, signs of inflammation within the gingiva of the oral cavity, the health of the tissues in the mouth (clinical parameters of periodontal disease), and the bacteria in the mouth and gut of newborns among pregnant individuals in Malawi. conditions: Dysbiosis conditions: Inflammation Gum studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Participants, data collectors (i.e. dental officers, study staff members, clinical officers), and data analysts will be blinded (triple-blinded) to group allocation throughout the study. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Xylitol gum name: Sorbitol gum measure: Periodontal disease at 28-30 weeks of pregnancy measure: Periodontal disease at 6 weeks postpartum measure: Alterations in the maternal oral microbiome communities delivery measure: Alterations in the maternal vaginal microbiome communities measure: Inflammatory mediator changes in the maternal gingival crevicular fluid at measure: Alterations within the infants' oral microbiome communities measure: Alterations within the infants' gut microbiome communities sex: FEMALE minimumAge: 12 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: Area 25 Health Center city: Lilongwe country: Malawi name: Benjamin Shayo role: CONTACT phone: +265980888996 email: benjamin.shayo@bcm.edu lat: -13.96692 lon: 33.78725 hasResults: False

 nctId: NCT06329583 id: 23-012635 briefTitle: Establishing Pressures at the EGJ During Diaphragmatic Breathing Using High-resolution Esophageal Manometry overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-26 date: 2024-03-26 name: Mayo Clinic class: OTHER briefSummary: The goal of this study is to determine which position, maneuvers or combination thereof generates the highest pressure at the EGJ as assessed by high-resolution esophageal manometry and thus greater or more robust contraction of the diaphragm. conditions: Gastroesophageal Reflux conditions: Dysphagia conditions: Esophageal Motility Disorders studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: diaphragmatic breathing measure: Pressure at the esophagogastric junction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06329570 id: NF-2023-03 briefTitle: Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM) overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-12-31 date: 2027-03-31 date: 2024-03-26 date: 2024-03-26 name: NaviFUS Corporation class: INDUSTRY name: NaviFUS US LLC briefSummary: This will be a prospective, open-label, single-arm pilot study to investigate the safety and efficacy of Bevacizumab (BEV) in combination with microbubble (MB)-mediated FUS in patients with recurrent GBM. BEV represents the physician's best choice for the standard of care (SoC) in rGBM after previous treatment with surgery (if appropriate), standard radiotherapy with temozolomide chemotherapy, and with adjuvant temozolomide. conditions: Glioblastoma Multiforme conditions: Glioblastoma conditions: Glioma conditions: Brain Tumor conditions: Neoplasms conditions: Neoplasms, Nerve Tissue studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: NaviFUS System name: Lumason name: Bevacizumab measure: Adverse Events (AEs) measure: 6-month Progression-Free Survival (PFS-6) measure: Progression-Free Survival (PFS) measure: One-year Survival Rate measure: Overall Survival (OS) measure: Objective Response Rate (ORR) measure: Clinical Benefit Rate (CBR) measure: Local Disease Control on the MRI Images measure: Corticosteroid Consumption measure: Quality of life (QoL) assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Virginia city: Charlottesville state: Virginia zip: 22903 country: United States name: Jason Sheehan, M.D., Ph.D. role: CONTACT phone: 434-924-8129 email: JPS2F@uvahealth.org name: Arthur Lung, Ph.D. role: CONTACT phone: 02-25860560 phoneExt: 180 email: arthur.lung@navifus.com lat: 38.02931 lon: -78.47668 hasResults: False

 nctId: NCT06329557 id: 23-007188 briefTitle: Optimizing the Patient Experience Through Provider Coaching or Communication Intervention overallStatus: ENROLLING_BY_INVITATION date: 2024-03-08 date: 2025-02 date: 2026-02 date: 2024-03-26 date: 2024-04-19 name: Mayo Clinic class: OTHER briefSummary: Hypothesis: Clinicians who receive patient experience coaching or communication classes have improved patient satisfaction scores and improved clinician satisfaction. conditions: Patient Satisfaction conditions: Communication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 45 type: ESTIMATED name: Intervention 1 measure: To identify if patient experience coaching or communication classes have an effect on patient satisfaction scores and clinician satisfaction. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06329544 id: STUDY-23-01572 id: 1R01DK137968-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01DK137968-01 briefTitle: High Fructose Diet, the Gut Microbiome, and Metabolic Health overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-02 date: 2028-11 date: 2024-03-26 date: 2024-03-26 name: Icahn School of Medicine at Mount Sinai class: OTHER name: Metabolic Solutions Inc. name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: Americans commonly consume excess amounts of dietary fructose. Added fructose has been shown to have an adverse impact on metabolic health, including increased insulin resistance and type 2 diabetes (T2D) risk. However, the mechanisms that link dietary fructose and metabolic health are poorly understood. Malabsorption or incomplete metabolism of fructose in the small intestine is common in the population. Excess fructose reaches the colon where it may change the structure and function of the gut microbiome, alter bacterial metabolites and trigger inflammatory responses impacting T2D risk. To elucidate whether commonly consumed levels of dietary fructose influence metabolic outcomes through altering the gut microbiome, the research team will randomize 30 participants to a controlled cross-over dietary intervention, in which the participants will consume 12-day isocaloric, added fructose or glucose diets (25% of total calories) separated by a 10-day controlled diet washout period.

The research team aims to:

1. Determine the relationships between high fructose consumption, the gut microbiome and metabolic risk.
2. Characterize the causal role(s) that fructose-induced alterations to the gut microbiome have on metabolic risk using a germ-free mouse model.

The research team will measure 1) microbiota community structure and function via metagenomic sequencing of stool, 2) fecal metabolites via targeted and untargeted metabolomics, 3) anthropometrics, 4) insulin resistance, serum markers of T2D risk and inflammatory cytokines, 5) fecal microbial carbohydrate oxidation capacity and 6) liver fat via MRI elastography. The research team will use novel statistical approaches, including Distributed Lag Modeling, to understand the complex relationships between diet, the microbiome, metabolites and health outcomes.

The research team will then conduct controlled dietary interventions and fecal microbiome transplantation studies in germ-free mice. Donor fecal samples from human participants in both the glucose and fructose arms of the clinical intervention will be transplanted into germ-free and colonized mice to establish a causal relationship between fructose-induced changes to the gut microbiome, liver fat and metabolic and inflammatory changes known to increase risk for T2D.

The research team aims to comprehensively assess the structural and functional changes to the gut microbiome brought about by a high fructose diet. Determining the impact of excess fructose on the microbiome will help identify novel means by which fructose contributes to metabolic disease risk. In addition to identifying strategies to improve metabolic health in adults, data from this proposal could help inform targeted approaches to mitigate future disease risk in vulnerable populations that consume high levels of fructose, such as children. conditions: MASLD conditions: Type 2 Diabetes conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study will be a double-blinded (participants and select study personnel), randomized controlled crossover dietary intervention design. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: All participants undergo both treatment arms but will be blinded to the order. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Fructose name: glucose measure: Liver proton density fat fraction (PDFF) measure: Degree of fibrosis sex: ALL minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: Mount Sinai Morningside city: New York state: New York zip: 10025 country: United States name: Ryan Walker role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06329531 id: 2022-0992 id: NCI-2024-02555 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Validation of the Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS) Tool for Use in a Physical Medicine Rehabilitation Clinic overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-22 date: 2025-04-22 date: 2024-03-26 date: 2024-03-28 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To compare the results of the SOCS-OTS to another standardized screening measure that is currently being used by rehabilitation services at MD Anderson Cancer Center and to ensure that the SOCS-OTS correctly identifies those individuals needing OT services in cancer care. conditions: Cancer conditions: Occupational Therapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS) measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Ekta Gupta, MD role: CONTACT phone: 713-745-2327 email: egupta@mdanderson.org name: Ekta Gupta, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06329518 id: HHC-2024-0064 briefTitle: Rezafungin PK in Patients on ECMO overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-03-26 date: 2024-03-26 name: Hartford Hospital class: OTHER name: Melinta Therapeutics, LLC briefSummary: Extracorporeal membrane oxygenation (ECMO) is a form of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and reinfused into the patient's circulation. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how ECMO circuits affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum echinocandin, Rezafungin, in critically ill patients receiving ECMO conditions: Sepsis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 8 type: ESTIMATED name: Rezafungin measure: Rezafungin Clearance measure: Rezafungin Area Under the Curve (AUC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hartford Hospital city: Hartford state: Connecticut zip: 06102 country: United States lat: 41.76371 lon: -72.68509 hasResults: False

 nctId: NCT06329505 id: 111-085-B briefTitle: Impact of Extracorporeal Membrane Oxygenation Care Strategy Application Development overallStatus: ACTIVE_NOT_RECRUITING date: 2023-06-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-26 date: 2024-03-26 name: Pei-Hung Liao class: OTHER briefSummary: The objective of this study was to develop an educational training App for ECMO care, and to apply a blended learning approach to improve the knowledge and skills of nurses. conditions: Learning Problem studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: Comparison of knowledge and skills of nurses between groups after the intervention For 6 months. sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: National Taipei university of nursing and health science city: Taipei country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06329492 id: 23-007937 briefTitle: Autologous Alpha-2 Macroglobulin Rich Plasma, Safety and Efficacy in Symptomatic Moderate Knee Osteoarthritis acronym: A2MRP overallStatus: ENROLLING_BY_INVITATION date: 2024-01-09 date: 2024-12-31 date: 2025-12-31 date: 2024-03-26 date: 2024-04-10 name: Mayo Clinic class: OTHER briefSummary: The purpose of this study is to determine the effectiveness and safety of autologous alpha-2 macroglobulin rich plasma (A2MRP) injections in the treatment of knee osteoarthritis (OA). conditions: Osteoarthritis conditions: OA conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single group cohort of 20 subjects primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP) measure: Adverse Events measure: Visual Analog Scale (VAS) for Pain measure: Patient-Reported Outcomes Measurement Information System (PROMIS)-Computer adaptive test (CAT): Pain interference measure: Patient-Reported Outcomes Measurement Information System (PROMIS)-Computer adaptive test (CAT): Physical function measure: Knee Injury and Osteoarthritis Outcome Score (KOOS): measure: Procedure Recommendation sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06329479 id: 1926B briefTitle: A Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI) overallStatus: RECRUITING date: 2023-06-01 date: 2024-06-01 date: 2024-09-01 date: 2024-03-26 date: 2024-03-26 name: University of Dublin, Trinity College class: OTHER briefSummary: Circadian rest-activity rhythm disorders are common in patients with cancer, particularly in advanced disease. A recent international e-Delphi study has outlined recommendations for the assessment and reporting of the disorder and subsequently an observation study is underway assessing a cohort of patients with advanced cancer. Affected patients are eligible to enter a feasibility study assessing a non-pharmacological multi-modal intervention. conditions: Circadian Rhythm Disorders conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Cognitive behavioural therapy for Insomnia (CBT-I) name: Bright Light Therapy name: Individualised activity plan name: Clincial review measure: Acceptability and usability of a multi-modal non-pharmacological intervention measure: Adherence to interventions measure: Adverse events measure: Completion rates of research assessments measure: Recruitment rate measure: Symptom assessment measure: Quality of Life assessment measure: Daytime Sleepiness measure: Sleep Quality measure: Physical activity assessment measure: Physical activity and sleep assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Our Lady's Hospice & Care Services status: RECRUITING city: Dublin zip: D6W RY72 country: Ireland name: Craig Gouldthorpe role: CONTACT phone: +3534986235 email: gouldthc@tcd.ie lat: 53.33306 lon: -6.24889 facility: St James's Hospital status: RECRUITING city: Dublin zip: D6W RY72 country: Ireland name: Craig Gouldthorpe role: CONTACT phone: +3534986235 email: gouldthc@tcd.ie lat: 53.33306 lon: -6.24889 hasResults: False

 nctId: NCT06329466 id: 0000-0002-4205-669X briefTitle: The Effect of Emotional Freedom Technique (EFT) on Pain Intensity and Menstruation Symptoms acronym: EFT overallStatus: ACTIVE_NOT_RECRUITING date: 2022-01-28 date: 2024-06-25 date: 2024-07-25 date: 2024-03-26 date: 2024-03-26 name: Gulay Coskun class: OTHER name: Mersin University briefSummary: The most important indicator of the fertility period, which has an important place in a woman's life, is the menstrual cycle, which begins with menarche and continues until menopause. In this natural process that takes place every month physiologically, some women experience significant pain \[1\]. This condition, defined as dysmenorrhea (painful menstruation), is classified in two ways as primary dysmenorrhea (PD) and secondary dysmenorrhea (SD) \[2,3\]. PD is the most common women's health problem, especially in adolescents and young adults (10-20 years of age) \[1,5\].

When studies on the incidence and severity of primary dysmenorrhea are examined, the incidence of PD is seen at rates ranging from 40-90% \[5-8\].

The main goal of the treatment approach to PD, which negatively affects women's quality of life in many ways, is to relieve the woman by reducing the pain. Emotional Freedom Technique (EFT) is one of the non-pharmacological and integrated treatment methods for women with primary dysmenorrhea. This practice, which is also referred to as EFT stroke/touch in most sources, is based on expressing the problem by touching the energy meridian points of the body, as in acupuncture and acupressure.

Considering the results of the studies, it can be said that EFT is effective in the management of pain and the negative effects caused by the restrictions in the life of the person (social and daily living activities, etc.) \[27-30\]. Thanks to EFT, it is thought that women will contribute to the reduction of the fear and anxiety of experiencing pain just before menstruation and the anxiety that their life will be limited due to this.

Studies investigating the effect of EFT on pain have reported that it is effective in coping with pain \[33-35\]. However, no randomized controlled study was found in the literature search for the application of EFT in high school students with dysmenorrhea. For this reason, it is thought that if EFT is applied in this age period with a high incidence of dysmenorrhea, important findings can be achieved in terms of parameters such as pain intensity and menstrual symptoms, and it will contribute to the literature by shedding light on similar studies. \[36\]. Therefore, in this study, it was aimed to determine the effect of the emotional freedom technique applied to high school students with primary dysmenorrhea on pain severity and menstruation symptoms. conditions: Dysmenorrhea Primary studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 48 type: ACTUAL name: intervention (EFT) group measure: Mcgill Pain Scale measure: Menstruation Symptom Scale measure: VAS pain scale sex: FEMALE minimumAge: 14 Years maximumAge: 17 Years stdAges: CHILD facility: Mersin University city: Yenişehir state: Mersin zip: 33343 country: Turkey lat: 40.26444 lon: 29.65306 hasResults: False

 nctId: NCT06329453 id: 2000033081 briefTitle: Intestinal Immunity in Neurologic Disease overallStatus: RECRUITING date: 2022-08-02 date: 2027-08-31 date: 2027-08-31 date: 2024-03-26 date: 2024-03-26 name: Yale University class: OTHER briefSummary: The purpose of this study is to ascertain the functional profiles of the immune cells within the gastrointestinal tract and to determine how these cells contribute to autoimmune and neurologic diseases. conditions: Multiple Sclerosis conditions: Parkinson Disease conditions: REM Sleep Behavior Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Colon Tissue Biopsy measure: Characterization of immune cells from the gastrointestinal mucosa measure: Evaluate spatial transcriptomics of intestinal tissue measure: Characterize the microbiome at different anatomic sites within the gastrointestinal tract sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yale MS Clinic status: RECRUITING city: North Haven state: Connecticut zip: 06473 country: United States name: Cynthia Marques role: CONTACT phone: 203-287-6100 email: cynthia.marques@yale.edu name: Dimitri Duvilaire role: CONTACT phone: 2032876100 email: dimitri.duvilaire@yale.edu name: Erin Longbrake, MD role: PRINCIPAL_INVESTIGATOR lat: 41.39093 lon: -72.85954 hasResults: False

 nctId: NCT06329440 id: 2023/880 briefTitle: Comparison of Supraclavicular and Costoclavicular Brachial Plexus Blocks in Adult Patients overallStatus: RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-10-05 date: 2024-03-26 date: 2024-04-18 name: Istanbul University class: OTHER briefSummary: Hemidiaphragmatic paresis is a common side effect of brachial plexus blocks such as supraclavicular or infraclavicular block techniques. It has been shown that diaphragma thickness is affected at some extent in supraclavicular block and also in costoclavicular block which is accepted as an infraclavicular approach. However, these two approaches have not been extensively investigated before in terms of the diaphragmatic paresis. Here, it is aimed to compare these two methods considering their effects on diaphragma thickness in inspirium and in expirium. Moreover, the performance properties such as motor and sensory block onset, needle visualization time, needle visualization difficulty, postoperative pain scores, and lastly the perfusion index which is known to be reflecting vasodilation will be investigated. conditions: Diaphragm Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Ultrasonographic measurement of diaphragm thickness measure: Diaphragm thickness fraction (centimeters) measure: Diaphragm thickness at the end of expirium (centimeters). measure: Diaphragm thickness at the end of inspirium (centimeters). measure: Perfusion index change measure: Motor and sensory block onset time measure: Postoperative pain scores (0-10) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul University Istanbul Faculty of Medicine status: RECRUITING city: Istanbul country: Turkey name: Meltem Savran Karadeniz, MD, Assoc Prof role: CONTACT email: mskaradeniz@gmail.com name: Ozgur Selek, MD role: CONTACT phone: 00905057883600 lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06329427 id: IRB00098063 briefTitle: Dragon Ambient eXperience (DAX) Copilot Evaluation acronym: DAX overallStatus: COMPLETED date: 2023-06-19 date: 2023-12-15 date: 2023-12-15 date: 2024-03-26 date: 2024-03-29 name: Wake Forest University Health Sciences class: OTHER name: Hieu Nguyen, MS - Biostatician name: McKenzie Isreal, MPH - project manager name: Casey Stephens, MPH - Health services researcher briefSummary: AI solutions like, Dragon Ambient eXperience (DAX) Copilot (Nuance/Microsoft), hold the potential to significantly enhance provider and patient interactions and alleviate pain points that contribute to burn out. Atrium Health was the first healthcare system in the world to pilot Nuance's DAX Copilot intelligence (AI) enabled scribe software, which synthesizes a draft clinic note by "listening" to the conversation between a provider and patient. After 180 days of use by primary care clinicians and advanced practice providers (APPs), along with a control group, the investigators assess provider satisfaction, patient experience, and provider efficiency through qualitative and quantitative methods. conditions: Automated Clinical Documentation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 238 type: ACTUAL name: Dragon Ambient eXperience (DAX) Copilot measure: Total EHR time measure: Work outside of work measure: Time on encounter note documentation measure: Completed appointment rate measure: Same day closure rate measure: Note length measure: Gross revenue per visit measure: wRVU per visit measure: Provider satisfaction measure: Provider interview measure: Patient satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Atrium Health Navicent city: Macon state: Georgia zip: 31201 country: United States lat: 32.84069 lon: -83.6324 facility: Atrium Health Floyd city: Rome state: Georgia zip: 30165 country: United States lat: 34.25704 lon: -85.16467 facility: Atrium Health city: Charlotte state: North Carolina zip: 28203 country: United States lat: 35.22709 lon: -80.84313 facility: Scotland Health Care System city: Laurinburg state: North Carolina zip: 28352 country: United States lat: 34.77405 lon: -79.46282 facility: Atrium Health Wake Forest Baptist city: Winston-Salem state: North Carolina zip: 27157 country: United States lat: 36.09986 lon: -80.24422 hasResults: False

 nctId: NCT06329414 id: 00164631 briefTitle: Acceptability and Feasibility of Transcranial Magnetic Stimulation (TMS) for Depression in Multiple Sclerosis overallStatus: RECRUITING date: 2024-01-16 date: 2026-01 date: 2026-01 date: 2024-03-25 date: 2024-03-25 name: University of Utah class: OTHER briefSummary: The goal of this single-arm, observational pilot study is to learn about the safety, feasibility, preliminary efficacy of TMS for the treatment of depression in people with MS. Participants will receive outpatient TMS treatment over the course of 5-6 weeks. Participants will complete validated questionnaires and exams before, during, and after treatment. conditions: Multiple Sclerosis conditions: Major Depressive Disorder conditions: Treatment Resistant Depression studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 12 type: ESTIMATED measure: Feasibility of TMS treatment for MDD, per participant retention rates. measure: Safety and tolerability, to be evaluated by side effects and adverse events over the course of treatment. measure: Depression response rates (50% reduction in symptoms) will be measured using MADRS scores before and after treatment. measure: Depression remission rates will be measured using MADRS scores before and after treatment. measure: MS lesion burden on MRI will be compared before and after treatment to determine impact of TMS on white matter disease burden. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Utah Health status: RECRUITING city: Salt Lake City state: Utah zip: 84108 country: United States name: Kathleen Shangraw, MD role: CONTACT phone: 801-583-2500 lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06329401 id: AP01-007 briefTitle: A Study Evaluating the Safety and Efficacy of AP01 in Participants With Progressive Pulmonary Fibrosis (PPF) overallStatus: RECRUITING date: 2024-04-03 date: 2026-04 date: 2026-04 date: 2024-03-25 date: 2024-04-24 name: Avalyn Pharma Inc. class: INDUSTRY name: DevPro Biopharma briefSummary: A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 versus placebo on top of standard of care in participants with PPF over 52 weeks. conditions: Progressive Pulmonary Fibrosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: AP01 name: Placebo measure: To evaluate the effect of AP01 high dose twice a day (BID) or AP01 low dose twice a day (BID) compared to placebo twice a day (BID) measure: To evaluate the effect of AP01 high dose, AP01 low dose compared to placebo on quality of life (QoL) measure: To evaluate the effect of AP01 high dose and AP01 low dose compared to placebo on disease progression (defined as absolute FVC percent predicted decline of ≥10% prior to Week 52) measure: To evaluate the change from baseline in quantitative lung fibrosis score. measure: To evaluate the safety of AP01 high dose and AP01 low dose compared to placebo sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Newport Native MD, Inc. status: RECRUITING city: Newport Beach state: California zip: 92663 country: United States lat: 33.61891 lon: -117.92895 facility: Paradigm Clinical Research - Redding status: NOT_YET_RECRUITING city: Redding state: California zip: 96001 country: United States lat: 40.58654 lon: -122.39168 facility: Clinical Site Partners, LCC status: NOT_YET_RECRUITING city: Leesburg state: Florida zip: 34748 country: United States lat: 28.81082 lon: -81.87786 facility: Renstar Medical Research status: NOT_YET_RECRUITING city: Ocala state: Florida zip: 34470 country: United States lat: 29.1872 lon: -82.14009 facility: Clinical Site Partners status: NOT_YET_RECRUITING city: Winter Park state: Florida zip: 32789 country: United States lat: 28.6 lon: -81.33924 facility: Accellacare status: RECRUITING city: Wilmington state: North Carolina zip: 28401 country: United States lat: 34.22573 lon: -77.94471 facility: Southeastern Research Center status: NOT_YET_RECRUITING city: Winston-Salem state: North Carolina zip: 27103 country: United States lat: 36.09986 lon: -80.24422 facility: Lowcountry Lung and Critical Care status: RECRUITING city: Charleston state: South Carolina zip: 29406 country: United States lat: 32.77657 lon: -79.93092 hasResults: False

 nctId: NCT06329388 id: CSD-SFRI-013 briefTitle: Evaluating the Effects of an Oral Protein Supplement on Children's Growth Patterns overallStatus: COMPLETED date: 2023-01-18 date: 2023-07-07 date: 2023-08-11 date: 2024-03-25 date: 2024-03-26 name: TruHeight Vitamins class: INDUSTRY name: San Francisco Research Institute briefSummary: This single-center, randomized controlled pilot study aims to evaluate the efficacy of TruHeight Growth Protein Shake on improving growth patterns in children aged 4-17 years. Over six months, participants will consume the protein shake daily, five times a week, with outcomes measured in terms of type X collagen concentration in urine, height via a stadiometer, and body composition using an INBODY device. conditions: Growth Disorders conditions: Dietary Exposure conditions: Child Development conditions: Bone Development Abnormal conditions: Body Weight conditions: Child Malnutrition studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial (RCT) with two parallel groups (treatment and control group). primaryPurpose: TREATMENT masking: NONE count: 32 type: ACTUAL name: TruHeight Growth Protein Shake measure: Change in Height measure: Change in Type X Collagen Concentration in Urine measure: Change in Body Composition measure: Incidence of Adverse Events sex: ALL minimumAge: 4 Years maximumAge: 17 Years stdAges: CHILD facility: SF Research Institute city: San Francisco state: California zip: 94127 country: United States lat: 37.77493 lon: -122.41942 hasResults: False

 nctId: NCT06329375 id: 72967 briefTitle: Food Insecurity Reduction & Strategy Team acronym: FIRST overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-02-05 date: 2025-02-05 date: 2024-03-25 date: 2024-04-17 name: Stanford University class: OTHER briefSummary: This study seeks to address the multifaceted challenges posed by food disparities and their negative consequences on health outcomes, via a comprehensive community health intervention program. Study objectives include:

1. To describe the social-demographic and clinical factors associated with food insecurity in the hospitalized diabetic population.
2. To design, implement and evaluate a nutrition program targeting the hospitalized diabetic population. The investigators will prospectively randomize the target population into either a nutrition program (Intervention), or state-of-art standard of care (SOC) in a 4:1 ratio. Participants in the intervention group will be provided the following two resources in addition to SOC: 1) Enhanced access to nutritious food (twice daily meal delivery up to 90 days post-discharge) 2) Education at discharge and continuing outreach to enhance knowledge for better diet and food options.
3. To enhance community engagement and develop a systematic implementation plan for long-term roll-out of the nutrition program. conditions: Diabetes Mellitus, Type 2 conditions: Food Insecurity conditions: Diabetes Mellitus, Type 1 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be prospectively randomized into either a nutrition program (intervention), or receiving state-of-the-art standard of care (SOC) in a 4:1 ratio. Patients in the intervention group will be provided the following two resources in addition to SOC:

1. Enhanced access to nutritious food (twice daily meal delivery up to 90 days post-discharge),
2. Education at discharge and continuing outreach to enhance knowledge for better diet and food options primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 160 type: ESTIMATED name: Nutrition program measure: Food insecurity at 30-days post initial discharge measure: Food insecurity at 60- and 90- days post post initial discharge measure: Measures of diabetes stress measure: Measures of hypoglycemia measure: Measures of medication adherence measure: Hospitalization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06329362 id: 2-7-23 briefTitle: Minimally Invasive Ridge Splitting Versus the Conventional Open Flap Technique overallStatus: RECRUITING date: 2023-07-31 date: 2025-07 date: 2025-07 date: 2024-03-25 date: 2024-03-26 name: The Royal College of Surgeons of Edinburgh class: OTHER briefSummary: The goal of this clinical trial is to compare implant stability, and crestal bone loss, when using minimal invasive ridge splitting versus convenient open flap technique. The main question is Does Minimal Invasive Implant ridge splitting ("transmucosal" without flap) influence the implant stability and crystal bone loss, when compared with the conventional open flap techniques? Researchers will compare Group A: Minimal Invasive Implant ridge splitting and Group B: Triangular flap technique is used to see if there is significant difference between the two groups when measuring implant stability, and crestal bone density. conditions: Alveolar Bone Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 16 type: ESTIMATED name: Minimally invasive implantation name: Open flap procedure for ridge expansion. measure: Implant stability. measure: CBCT assessment measure: Postoperative Pain measure: Operation Time sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Dentistry Cairo University status: RECRUITING city: Cairo zip: 35855 country: Egypt name: Bassem Emad, MDs role: CONTACT phone: +201001113474 email: bassem_26@hotmail.com name: Emad Deif, Prof role: CONTACT phone: +201222331938 email: daif_emad@yahoo.com lat: 30.06263 lon: 31.24967 facility: Future Dental Academy GmbH status: RECRUITING city: Flonheim state: Rheinland - Pfalz zip: D-55237 country: Germany name: Armin Nadjet, A.Prof role: CONTACT phone: +4915115253692 email: nedjat@t-online.de name: Rainer Zoppke role: CONTACT phone: +491778339601 email: Rainer.Zoppke@champions-implants.com lat: 49.785 lon: 8.04 hasResults: False

 nctId: NCT06329349 id: EK VP57/0/2023 briefTitle: Metabolic Flexibility to Predict Lifestyle Interventions Outcomes acronym: MEPHISTO overallStatus: RECRUITING date: 2024-01-02 date: 2025-12-12 date: 2026-04-01 date: 2024-03-25 date: 2024-03-25 name: Charles University, Czech Republic class: OTHER name: Ministry of Health, Czech Republic name: EXCELES LX22NPO5104, CarDia briefSummary: Weight loss is a cornerstone of diabetes (T2D) management, yet in clinical practice, its delivery is limited by its perceived burdensome nature and variability in response. Personalization of the interventions to increase their success rate is an unmet clinical need. The proposed project MEPHISTO (Whole body and gut microbiome metabolic flexibility to predict lifestyle intervention outcomes) would aim to identify predictive features related to successful weight loss upon sequential exercise and diet intervention in people living with obesity. To this end, the study aims to conduct a clinical trial where the investigators would implement state-of-the-art physiological phenotyping of metabolic flexibility at the whole-body level and at the level of the gut in persons with obesity before and after exercise and diet + exercise intervention to identify predictive signatures of successful weight loss conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2:1 randomized cross-over primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Exercise name: Combined Exercise + Diet measure: Change in metabolic flexibility (MetFlex (ΔRQ 200-0)) measure: Change in insulin sensitivity measure: Glucose tolerance relate to primary outcomes changes measure: HbA1c relate to primary outcomes changes measure: Insulin sensitivity relate to primary outcomes changes measure: Microbiome composition relate to weight loss: exploratory outcome measure: Metabolomic signatures relate to weight loss: exploratory outcome sex: FEMALE minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: University Hospital Kralovske Vinohrady status: RECRUITING city: Prague zip: 10034 country: Czechia name: Jan Gojda, PhD role: CONTACT phone: +420267163031 email: jan.gojda@lf3.cuni.cz name: Katerina Koudelkova, MD role: CONTACT phone: +420267163031 email: katerina.koudelkova@fnkv.cz lat: 50.08804 lon: 14.42076 facility: Third Medical Faculty,Charles University status: RECRUITING city: Prague zip: 10084 country: Czechia name: Michaela Šiklová, PhD role: CONTACT phone: +420267102222 email: michaela.siklova@lf3.cuni.cz name: PhD role: CONTACT phone: +420267163031 email: jan.gojda@lf3.cuni.cz lat: 50.08804 lon: 14.42076 facility: Faculty of Sports Science status: RECRUITING city: Prague zip: 16000 country: Czechia name: Michal Šteffl, PhD role: CONTACT phone: +420220172072 email: michal.steffl@ftvs.cuni.cz name: Tomáš Větrovský, PhD role: CONTACT phone: +420220172072 email: tomas.vetrovsky@ftvs.cuni.cz lat: 50.08804 lon: 14.42076 hasResults: False

 nctId: NCT06329336 id: STUDY00019653 id: UL1TR002319 type: NIH link: https://reporter.nih.gov/quickSearch/UL1TR002319 briefTitle: Parenting Support for Justice Involved Families overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-03-30 date: 2025-04 date: 2024-03-25 date: 2024-04-24 name: University of Washington class: OTHER name: National Center for Advancing Translational Sciences (NCATS) briefSummary: Together with the Community Care Team of King County Community Partnership for Transition Solutions (KCCPTS), the investigators propose to collaborate in adapting parenting intervention(s) to support the well-being and effective parenting of parents re-entering the community, as well as that of their children's primary caregiver. The aim is promoting the well-being of the parents/caregivers and their children, fostering positive child development, and ultimately, preventing the intergenerational transmission of adversity. The KCCPTS Community Care Team includes re-entry navigators who have lived experience of adversity and incarceration, bringing their unique insights regarding the re-entry experience, from both personal and professional experiences. This study will evaluate a task-sharing approach to offering formerly incarcerated parents and their families a parenting support intervention. That is, re-entry navigators will be trained to deliver evidence-based parenting interventions. This increases the feasibility and accessibility of the program, particularly because facilitators have shared experiences and trusted connections with their clients. This project proposes four main activities: 1) conduct focus groups with parents re-entering the community to better understand their parenting needs, 2) work with KCCPTS re-entry navigators to incorporate information from their experience and the focus group to adapt a parenting intervention, 3) train re-entry navigators to deliver the program, and 4) conduct a preliminary evaluation of the impact of the program on parents' well-being and parenting when the program is delivered by KCCPTS re-entry navigators. If this preliminary evaluation shows promise in supporting parent well-being and parenting effectiveness, the investigators will seek funding to conduct a larger, more rigorous evaluation. conditions: Parenting conditions: Well-Being, Psychological conditions: Mental Health Wellness 1 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: Social Emotional Competence for Children and Parents measure: Parenting Behavior Inventory - Very short Form measure: PHQ-9 Depressive Symptoms measure: GAD-7 Anxiety Symptoms measure: Brief Resilience Scale measure: Self-Compassion Scale - Short Form measure: Strengths and Difficulties Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06329323 id: 23CX8477 briefTitle: SerUm and Plasma MicroRNAs in Malignant Ovarian gERm Cell Tumours acronym: SUMMER overallStatus: NOT_YET_RECRUITING date: 2024-04-14 date: 2027-04 date: 2028-04 date: 2024-03-25 date: 2024-03-26 name: Imperial College London class: OTHER briefSummary: The goal of this observational case-control study is to learn about the circulating and tissue microRNA expression, imaging and radiomic profiles of malignant ovarian germ cell tumours (MOGCT) compared to patients with a benign OGCT and no ovarian pathology.

The main question\[s\] it aims to answer are:

1. To understand the circulating miRNA expression of malignant ovarian germ cell tumours (MOGCTs) compared to those with benign ovarian germ cell tumours (BOGCTs)
2. To understand the imaging profile of MOGCTs compared to that of BOGCTs
3. To establish the relationship between serum and plasma miRNA expression in response to treatment and relapse of disease
4. To discover if miRNA expression correlates with radiomic features of OGCTs on both ultrasound and MRI
5. To see if we can link the micro RNAs in tumour samples to those found in blood samples, and to find a plausible explanation for why these micro RNAs are raised (in terms of the tumour biology itself).aims

Participants will have serial blood tests at different time points in their care to assess how circulating miRNA levels are affected by treatment and/or remission and/or relapse. If they have surgery, a pathology sample will be taken from the main tumour specimen. Radiomic analysis will take place on existing ultrasound images of their mass.

Researchers will compare the circulating miRNA profile of patients with a benign ovarian germ cell tumour and no ovarian pathology to see where the differences lie. If a patient with a BOGCT requires surgery, a pathology sample will be taken from the main tumour specimen. Radiomic analysis will take place on existing ultrasound images of their benign mass. conditions: Germ Cell Ovarian Cancer conditions: Germ Cell Tumor conditions: Germ Cell Cancer conditions: Germ Cell Neoplasia conditions: Ovary Cancer conditions: Ovary Neoplasm conditions: Ovarian Cancer conditions: Ovarian Neoplasms studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 24 type: ESTIMATED name: Blood test name: Pathology specimen miRNA expression measure: Difference in microRNA expression (plasma) between benign and malignant masses measure: Difference in microRNA expression (serum) between benign and malignant masses measure: microRNA expression (plasma) measure: microRNA expression (serum) measure: Quantitative measure of circulating miRNA before treatment measure: Quantitative measure of circulating miRNA before treatment measure: Quantitative measure of circulating miRNA after treatment measure: Quantitative measure of circulating miRNA after treatment measure: Performance of segmentation model on ultrasound images measure: Performance of segmentation model on MRI images measure: Performance of classification model on ultrasound images measure: Performance of classification model on MRI images sex: FEMALE minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06329310 id: XEL-CR-14 briefTitle: Xeltis Hemodialysis Access Conduit: aXess-E Study overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-06 date: 2026-12 date: 2024-03-25 date: 2024-03-25 name: Xeltis class: INDUSTRY briefSummary: A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation. conditions: End Stage Renal Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: aXess-E conduit measure: Primary Patency rate measure: Freedom from device-related SAE measure: Implantation success rate measure: Primary patency rate measure: Primary assisted patency rate measure: Secondary patency rate measure: Functional patency rate measure: Time (expressed in months) to first intervention and to access abandonment measure: Rate of access-related interventions required to achieve/maintain patency measure: Freedom from device-related SAE measure: Rate of access site infections measure: Proportion of hemodialysis sessions completed via central venous catheter (CVC) during the first 12 months of access creation and access cannulation, irrespective of access abandonment measure: Time to first cannulation measure: Following first cannulation, number of days with CVC in situ (catheter contact time) irrespective of access abandonment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06329297 id: NUR23-1005 INPTCGM1 briefTitle: Continuous Glucose Monitoring in Inpatients overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2025-04 date: 2024-03-25 date: 2024-03-25 name: Parkview Health class: OTHER briefSummary: The purpose of this study is to contribute to current research regarding the feasibility and accuracy of CGM in the hospital setting for both the medical and cardiovascular intensive care (ICU) patient populations. conditions: Hyperglycemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: CGM monitor measure: CGM vs point of care test (POCT) glucose measure: Slow downward trend arrow on CGM device sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06329284 id: RC 31.1.2024 briefTitle: Midkine Role With Deregulated Oxidative and Immune Milieu in Induction of Preeclampsia overallStatus: COMPLETED date: 2023-01-01 date: 2023-09-15 date: 2023-12-15 date: 2024-03-25 date: 2024-03-26 name: Benha University class: OTHER briefSummary: Preeclampsia (PE) is a hypertensive pregnancy-related disorder that endangers maternal and fetal outcomes and accounts for 9-10% of maternal mortalities with its early-onset phenotype is the most dangerous, but its etiology is still not fully elucidated.

Midkine (MDK) is a multifunctional protein that plays a unique role in the development of hypertension (HTN), via its proatherogenic effect and induction of overexpression of angiotensin converting enzyme. Oxidative stress (OS) upregulates the expression of MDK and MDK induces propagation of neoangiogenesis and acts as chemotactic for neutrophils. conditions: Pre-Eclampsia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Newly pregnant normotensive (NT) women with singleton fetus primaryPurpose: DIAGNOSTIC masking: NONE count: 80 type: ACTUAL name: ELISA measure: Severity of Pre-Eclampsia (PE) sex: FEMALE minimumAge: 21 Years maximumAge: 50 Years stdAges: ADULT facility: Banha University city: Banhā state: El- Qalyobia zip: 13511 country: Egypt lat: 30.45906 lon: 31.17858 hasResults: False

 nctId: NCT06329271 id: 113022-E briefTitle: After Hip Fracture Nailing, Compare Early Weight Bearing as Tolerated (WBAT) Group With Weight Bearing Restriction(WBR) overallStatus: RECRUITING date: 2024-03-08 date: 2025-04-29 date: 2025-04-29 date: 2024-03-25 date: 2024-03-25 name: Far Eastern Memorial Hospital class: OTHER briefSummary: Purpose: Proximal femur fracture is a major traumatic injury in elderly populations; however, practical postoperative weight-bearing protocols are lacking. Therefore, the purpose of the present study was to investigate whether early weight-bearing status after proximal femur nail fixation is associated with any loss of reduction and evaluate the clinical outcomes of this intervention.

Patients and methods:

For this prospective single-center clinical trial study, we recruited 60 geriatric proximal femur fracture cases, classified by AO/OTA 2018, receiving intramedullary nail fixation. The participants were assigned to the Early-weight-bearing group (n= 30) or the Weight-bearing restriction group (n = 30). Clinical outcomes included the Harris functional hip score and VAS pain score. Additionally, demographic data, radiological parameters, time to weight-bearing, mortality rate, medical and surgical complications, and final ambulation status were recorded. conditions: Bony Weight Bearing Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Early-Weight bearing measure: Harris Hip Functional score measure: Harris Hip Functional score measure: Harris Hip Functional score measure: Harris Hip Functional score measure: Harris Hip Functional score measure: Visual analog pain score measure: Visual analog pain score measure: Visual analog pain score measure: Visual analog pain score measure: Visual analog pain score measure: Complication sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Far-Eastern Memorial Hospital status: RECRUITING city: New Taipei City zip: 220 country: Taiwan name: Yen Cheng Chen role: CONTACT phone: 886919207805 email: sstteevveepp@gmail.com lat: 25.01111 lon: 121.44583 hasResults: False

 nctId: NCT06329258 id: PTC09 briefTitle: Combination of Sotyktu and Enstilar for Plaque Psoriasis overallStatus: COMPLETED date: 2022-12-06 date: 2023-11-13 date: 2023-11-13 date: 2024-03-25 date: 2024-03-25 name: Psoriasis Treatment Center of Central New Jersey class: OTHER briefSummary: combination deucravacitinib and enstilar foam conditions: Psoriasis studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: open label primaryPurpose: TREATMENT masking: NONE count: 30 type: ACTUAL name: Enstilar name: Deucravacitinib measure: Psoriasis Area and Severity Index 75 at week 12 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Schweiger Derm Group city: East Windsor state: New Jersey zip: 08520 country: United States lat: 40.268 lon: -74.54043 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2021-08-30 uploadDate: 2024-03-14T10:41 filename: Prot_SAP_000.pdf size: 834542 hasResults: False

 nctId: NCT06329245 id: brainpro2022 briefTitle: Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2029-01-01 date: 2029-07-01 date: 2024-03-25 date: 2024-03-25 name: Children's Hospital of Fudan University class: OTHER name: ShanghaiTech University briefSummary: The goal of this observational study is to compare the developmental trajectories of prosocial behaviors and functional network connections in infants and toddlers at high and low risk of autism spectrum disorder (ASD). The main questions it aims to answer are what the differences in prosocial behaviors and related brain network connections between infants/toddlers at high and low risk of ASD are. Participants will receive developmental and social communicational assessments (Griffiths Mental Developmental Scales, Peabody Developmental Motor Scales, The Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist), resting-state EEG and MRI in a natural sleeping state. conditions: Autism or Autistic Traits conditions: Healthy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Do not take any interventions measure: clinical diagnosis measure: neurodevelopmental outcome measure: Prosocial behaviors measure: nuclear magnetic resonance imaging(MRI) measure: Event related potentials (ERPs) sex: ALL minimumAge: 0 Months maximumAge: 18 Months stdAges: CHILD hasResults: False

 nctId: NCT06329219 id: wIRA briefTitle: Water-filtered Infrared-A Radiation in Patients With Hand Osteoarthritis overallStatus: RECRUITING date: 2024-03-26 date: 2025-02-28 date: 2025-12 date: 2024-03-25 date: 2024-03-28 name: Charite University, Berlin, Germany class: OTHER briefSummary: The aim of this clinical trial is to evaluate the effects of water-filtered Infrared-A radiation on patients suffering from hand osteoarthritis. The main questions it aims to answer are:

* Does water-filtered Infrared-A radiation reduce pain and improve the function of finger joints over time?
* Are patients satisfied with the treatment results when compared to those who were on a wait-list? conditions: Hand Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: water-filtered Infrared-A radiation measure: Pain in the finger joints on visual analogue scale measure: Hand Dynamometer measure: Disabilities of Arm, Shoulder and Hand (DASH) questionnaire measure: Pain Self-Efficacy Questionnaire measure: Hospital Anxiety and Depression Scale (HADS) measure: Short Form (SF)-36 Health Survey (SF-36) measure: Functional Index for Hand OsteoArthritis (FIHOA) measure: Tolerability of the intervention measure: Pain medication (number per day) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité - Universitätsmedizin Berlin at the Department of Internal and Integrative Medicine, Immanuel Krankenhaus Berlin status: RECRUITING city: Berlin-Wannsee state: Berlin zip: 14109 country: Germany name: Miriam Rösner role: CONTACT phone: +49 30 80505 682 email: naturheilkunde.studien@immanuel.de lat: 52.41915 lon: 13.15531 hasResults: False

 nctId: NCT06329206 id: GH2616-101 briefTitle: A Phase Ia/Ib Study of GH2616 Tablet in Subjects With Advanced Solid Tumors overallStatus: RECRUITING date: 2024-03-13 date: 2026-04-25 date: 2026-09-01 date: 2024-03-25 date: 2024-04-03 name: Suzhou Genhouse Bio Co., Ltd. class: OTHER name: Zhejiang Cancer Hospital name: Henan Cancer Hospital name: Hubei Cancer Hospital name: The First Affiliated Hospital of Zhengzhou University briefSummary: This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics (PD) and preliminary efficacy of GH2616 Tablet in subjects with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib). conditions: Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 156 type: ESTIMATED name: GH2616 Tablets measure: Safety assessment measure: Objective response rate (ORR) measure: Progression-free survival (PFS) measure: Duration of response (DOR) measure: Plasma concentration (Cmax) measure: Area under the plasma concentration-time curve (AUC) measure: Time to achieve Cmax (Tmax) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Cancer Hospital status: RECRUITING city: Zhejiang country: China name: ZHENGBO SONG, DOCTORATE role: CONTACT phone: +8613857153345 email: zjccgcp_phase1@126.com hasResults: False

 nctId: NCT06329193 id: CBU-FTR-ES-O4 briefTitle: Effects of Mid-Season Camp Period Loading on Sports Injury Anxiety and Physical Performance overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05-07 date: 2024-05-15 date: 2024-03-25 date: 2024-03-25 name: Celal Bayar University class: OTHER briefSummary: The aim of this study is to investigate the effects of 3-week mid-season camp period loading on sports injury anxiety level and physical performances of professional male soccer players. conditions: Anxiety conditions: Exercise conditions: Athletic Performance studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 34 type: ESTIMATED name: Mid-Season Camp Period Loading measure: Sports Injury Anxiety measure: Muscle strength measure: Flexibility measure: Dynamic balance measure: Single-leg jump measure: Agility measure: Sprint sex: MALE minimumAge: 19 Years maximumAge: 22 Years stdAges: ADULT hasResults: False

 nctId: NCT06329180 id: 26.02.2024 briefTitle: Exercise in Mental Illness Questionnaire: French Validation overallStatus: ENROLLING_BY_INVITATION date: 2024-03-19 date: 2024-06-01 date: 2024-06-01 date: 2024-03-25 date: 2024-03-25 name: KU Leuven class: OTHER briefSummary: The validation of the French version of the Exercise in Mental Illness Questionnaire - Health Practitioner Version (EMIQ-HP) is a prospective observational case-only study involving: (a) translation to French, (b) an expert consensus meeting with French speaking experts from Canada to reach a first version, (c) back translation to English, (d) evaluation of the back-translation by the original authors of the EMIQ-HP, (e) an expert consensus meeting with French speaking experts from Canada to reach a final version based on comments of the original authors, and (f) test-retest reliability study. Test-retest reliability will be analysed through two points of measurement with an interval of 7 days. conditions: Exercise studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 42 type: ESTIMATED measure: Intra-class-correlation coefficients (ICC 3,1 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier Psychiatrique Chêne aux Haies city: Mons country: Belgium lat: 50.45413 lon: 3.95229 hasResults: False

 nctId: NCT06329167 id: 2024-HS-012 briefTitle: Daphnetin Capsules for Lower Limb Lymphoedema Following Gynaecological Surgery overallStatus: RECRUITING date: 2024-03-25 date: 2025-07-01 date: 2025-07-31 date: 2024-03-25 date: 2024-03-25 name: The First Hospital of Jilin University class: OTHER briefSummary: This clinical trial is designed to learn more about treating patients with lower limb lymphoedema following gynaecological surgery. The main question to be answered is To evaluate the efficacy of Daphnetin capsule in the treatment of patients with lower limb lymphedema following gynaecological malignancy surgery. Participants will take Daphnetin capsule 150mg tid (3 capsules/time, 3 times daily) orally at the same time as gradient compression stocking treatment. Researchers will compare 150mg Forte tablets (2 capsules/time, 2 times daily) and gradient compression stockings to see if Daphnetin capsule can be used to treat patients with lower extremity lymphedema following gynaecological malignancy surgery. conditions: Lower Extremity Lymphedema studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Daphnetin name: Aescuven measure: The difference in the circumference of the lower limbs measure: Gynaecological Cancer Lymphedema Questionnaire measure: Fibrinogen content sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the 1st hospital of Jilin University status: RECRUITING city: Chang Chun state: Jilin country: China name: Xiaosen Li Li role: CONTACT phone: +8618343116682 email: xiaosensen@jlu.edu.cn lat: 42.74694 lon: 126.24667 hasResults: False

 nctId: NCT06329154 id: PJ-KS-KY-2024-03(X) briefTitle: Clinical Study On Extracorporeal Shock Wave Therapy For Rotator Cuff Injuries overallStatus: RECRUITING date: 2024-02-27 date: 2025-01-27 date: 2025-02-27 date: 2024-03-25 date: 2024-03-25 name: Yong Liu, MD class: OTHER briefSummary: This clinical trial aims to learn about the effect of extracorporeal shock wave therapy on rotator cuff injuries. The main question it aims to answer is the efficacy of extracorporeal shock wave therapy on the improvement of pain, shoulder function, and quality of life in patients with rotator cuff injuries. The experimental group of patients received extracorporeal shock wave therapy combined with conventional rehabilitation therapy. The control group only received conventional rehabilitation therapy. Compare the two groups to explore the therapeutic effect of extracorporeal shock wave therapy on rotator cuff injuries. conditions: Rotator Cuff Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: assessor was blinded. The assessor, who not participated in the study, was experienced, and well qualified in the use. whoMasked: OUTCOMES_ASSESSOR count: 58 type: ESTIMATED name: Extracorporeal shock wave therapy name: conventional rehabilitation therapy measure: Change from Baseline Visual Analogue Scale at 4 weeks measure: Change from Baseline Range of Motion at 4 weeks measure: Change from Baseline Constant-Murley Score at 4 weeks measure: Change from Baseline Isokinetic muscle strength testing at 4 weeks measure: Change from Baseline Magnetic resonance imaging at 4 weeks measure: Change from Baseline Musculoskeletal ultrasound at 4 weeks measure: Change from Baseline American Shoulder and Elbow Surgeons Score at 4 weeks measure: Change from Baseline Shoulder Pain and Disability Index at 4 weeks measure: Change from Baseline Disability of the Arm, Shoulder and Hand Score at 4 weeks measure: Change from Baseline University of California at Los Angeles Shoulder Scale at 4 weeks measure: Change from Baseline Pittsburgh sleep quality index at 4 weeks sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Dalian Medical University status: RECRUITING city: Dalian state: Liaoning zip: 116011 country: China name: yong liu role: CONTACT phone: 18098876656 email: fuwa52008@126.com lat: 38.91222 lon: 121.60222 hasResults: False

 nctId: NCT06329141 id: HSG4112-P2-03 briefTitle: A Study to Assess the Efficacy and Safety of Vutiglabridin in Early Parkinson's Disease Patients overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-12-31 date: 2026-06-30 date: 2024-03-25 date: 2024-03-25 name: Glaceum class: INDUSTRY briefSummary: 1. Study Objective

   - To assess the efficacy and safety of vutiglabridin in early Parkindson's disease patients
2. Background Glaceum Inc. has evaluated the safety, tolerability, and pharmacokinetic/pharmacodynamic properties of vutiglabridin in healthy subjects through its Phase 1 trials, and is planning to perform this Phase 2a trial to assess the efficacy and safety of vutiglabridin in early Parkinson's disease patients.
3. Study Design and Protocol This study is a randomized, double-blind, placebo-controlled, parallel-group trial. Subjects deemed eligible to participate in this study based on the inclusion/exclusion criteria will be assigned a subject number and randomized to one of the 3 treatment groups - 1 group receiving a placebo - in a 1:1:1 ratio. Subjects will be randomized to double-blind treatments and will receive a once-daily oral dose of the investigational product for 24 weeks according to the study protocol. Several parameters (i.e., MDS-UPDRS, CGI-C, K-NMSS, modified Hoehn-Yahr stage and SNBR) will be evaluated to assess the efficacy of vutiglabridin. Assessments including measurement of vital signs, 12-lead ECG, clinical laboratory test, pregnancy test, physical examination, and adverse event monitoring will be performed to evaluate the safety and tolerability of vutiglabridin. Blood samples will be collected for pharmacokinetic assessment. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: Vutiglabridin name: Placebo measure: Change From Baseline in MDS-UPDRS Part III Subscore measure: Change From Baseline in MDS-UPDRS Part III Subscore measure: Change From Baseline in MDS-UPDRS Part II + Part III measure: Change From Baseline in CGI-C score measure: Change From Baseline in K-NMSS score measure: Change From Baseline in Modified Hoehn-Yahr stage measure: Change From Baseline in PET SNBR (Specific to Non-specific Binding Ratio) in the putamen, acudate and nucleus measure: Drop-out rate due to taking anti-parkinson drug sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06329128 id: 2022/04 briefTitle: Evaluation of the Effectiveness of Manual Therapy in Patients With Knee Osteoarthritis overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-06-30 date: 2024-09-30 date: 2024-03-25 date: 2024-03-25 name: Hasan Kalyoncu University class: OTHER briefSummary: The aim of this study is to investigate the effects of three different applications (Manual therapy, electrotherapy and home program) on long-term pain, joint range of motion and, secondarily, the functional level of the knee. conditions: Osteoarthritis, Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants were divided in two groups. One groups will get electrotherapy, exercise(home programme) and manuel therapy intervention. One group will be the control group. Control group will get electrotherapy and exercise (home programme). primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Experimental: Study Group name: Active Comparator: Control Group measure: The pain measure: Functional status measure: The quality of Life measure: Lower extremity functional strength and balance test measure: Functional mobility sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hasan Kalyoncu University city: Gaziantep state: Şahinbey zip: 27100 country: Turkey lat: 37.05944 lon: 37.3825 hasResults: False

 nctId: NCT06329115 id: 2024/23 briefTitle: Investigation of the Effectiveness of Regular Physical Activity in University Students overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-06-30 date: 2024-06-30 date: 2024-03-25 date: 2024-03-25 name: Hasan Kalyoncu University class: OTHER briefSummary: In our study, university students who coded the course from various faculties and departments within the scope of a university-wide free elective course, after regular physical activity; It was aimed to examine the effects on lifelong learning, physical activity, fatigue, sleepiness, depression, anxiety and stress levels, quality of life and walking distances and physiological expenditure indices. conditions: Regular Physical Activity conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Participants will be included in an 8-week regular exercise program. Evaluations will be made before and after exercise. primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Exercise training measure: Lifelong learning measure: Physical activity measure: Fatique measure: Daytime sleepiness measure: Depression, anxiety and stress measure: Quality of life measurement measure: Physiological expenditure indices sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hasan Kalyoncu University city: Gaziantep state: Şahinbey zip: 27100 country: Turkey lat: 37.05944 lon: 37.3825 hasResults: False

 nctId: NCT06329102 id: 93628 briefTitle: Right Colectomy for Colon Cancer Database (RCC). Surgical Technique, Route of Access and Quality of the Specimen acronym: RCC overallStatus: RECRUITING date: 2021-01-01 date: 2024-12-31 date: 2025-09-01 date: 2024-03-25 date: 2024-03-28 name: Haukeland University Hospital class: OTHER name: Intuitive Surgical briefSummary: Aim of the project is to surveil results after extended lymphadenectomy for right sided colon resection for cancer with different operative techniques. Patients operated for right sided colon cancer will be involved. There are different operative methods used in terms of extend of lymphadenectomy and access (open, laparoscopic and robotic assisted) that are already implemented. The Norwegian standard operation contains less extended lymph node dissection. Patients operated by the standard method will serve as control group. Choice of access and extend of lymph node dissection in Norway is dependant on the surgeon and hospital. At Haukeland University Hospital extend and access of surgery are determined by a multidisciplinary team meeting. More radical surgery might result in more complications and the benefit for the patients in terms of oncological result and survival is uncertain. At Haukeland University Hospital, extended lymphadenectomy has been mostly performed by open surgery. During the study phase we will introduce extended lymphadenectomy by laparoscopy and robotassisted surgery. Hypothesis is that more radical surgery performed by minimal invasive surgery will result in equal or better oncological results, and less complications, shorter hospital stay and better quality of life. As method we choose a prospective observational study. All eligible patients with adenocarcinoma of the right colon without another ongoing oncological treatment for other cancers will be included. Patientdata will be prospectively registered in a web-based database. Aim of the study will be to define the optimal extend of lymphadenectomy to achieve the best oncological result. In addition, we will analyse the results dependent on the surgical access (open, laparoscopic or robotic). The assumed difference between the operative methods is small. Therefore, the study is designed and approved as a multicenter registration in order to achieve the necessary statistical power. conditions: Right Sided Colon Cancer conditions: Right Colectomy conditions: Lymphadenectomy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Surgical access measure: Surgical complications defined by Calvien Dindo II to V measure: Surgical quality described by the specimen quality and number of lymph nodes harvested measure: Oncological quality will be measured by overall survival and recurrence measure: Quality of life after surgery measured with the 15D instrument sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Haukeland University Hospital status: RECRUITING city: Bergen zip: 5009 country: Norway name: Frank Pfeffer, Prof role: CONTACT phone: 48180021 phoneExt: 0047 email: frank.pfeffer@helse-bergen.no name: Havard Forsmo, PhD role: CONTACT phone: 48276232 phoneExt: 0047 email: havard.mjorud.forsmo@helse-bergen.no lat: 60.39299 lon: 5.32415 hasResults: False

 nctId: NCT06329089 id: HCB/2023/0840 briefTitle: Reoperative Sentinel Lymph Node Biopsy in Patients With Recurrent Ipsilateral Breast Cancer acronym: RENATA overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2025-12-31 date: 2024-03-25 date: 2024-03-25 name: Hospital Clinic of Barcelona class: OTHER briefSummary: The goal of this observational study is to assess the effectiveness of sentinel lymph node biopsy as a treatment approach for patients with recurrent breast cancer on the same side as previous surgeries. The main questions it aims to answer are:

* What is the rate of identification of the sentinel lymph node, and how does it vary among patients with different histories of axillary surgeries?
* How can we describe and understand the drainage pathways, including those from the armpit on the same side as the cancer, the area near the breastbone, and the opposite armpit?

Participants will undergo sentinel lymph node biopsy as part of their treatment for recurrent breast cancer. They will also receive standard treatments, including surgery and adjuvant therapies as recommended by their healthcare team. conditions: Recurrent Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 97 type: ESTIMATED name: Reoperative Sentinel Lymph Node Biopsy measure: Re-Sentinel Lymph node harvesting rate measure: Drainage pathways description measure: Complications rate measure: Axillary metastasis rate measure: Correlation Between Axillary and Internal Mammary Chain Infiltration measure: Quality of life in recurrent breast cancer sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clínic de Barcelona status: RECRUITING city: Barcelona zip: 08036 country: Spain name: Ines Torras Caral role: CONTACT phone: 93 227 54 00 phoneExt: 2499 email: itorras@clinic.cat lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06329076 id: BAM_lab_eyetracking_04 briefTitle: Losartan Modulates Neural Responses to Looming Visual Stimuli: An Eye-tracking Study overallStatus: RECRUITING date: 2024-03-05 date: 2025-06-01 date: 2025-07-30 date: 2024-03-25 date: 2024-04-11 name: University of Electronic Science and Technology of China class: OTHER briefSummary: The main aim of the present study is to investigate the effects of orally administered losartan on the perception of time-to-collision of threatening and non-threatening stimuli by combining a validated looming fear eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: Randomized placebo-controlled double-blind between-subject design whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Losartan name: Placebo measure: Ratio of judged-time-to-collision to actual-time-to-collision for threatening versus non-threatening stimuli after losartan administration measure: First saccade latency(ms) for threatening versus non-threatening stimuli after losartan administration measure: Fixation duration(ms) for threatening versus non-threatening stimuli after losartan administration sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Electronic Science and Technology of China status: RECRUITING city: Chengdu state: Sichuan country: China name: Weihua Zhao, Dr role: CONTACT phone: 86-28-61830811 email: zarazhao.uestc@outlook.com lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06329063 id: BAM_lab_eyetracking_03 briefTitle: Oral Vasopressin Modulates Neural Responses to Looming Visual Stimuli: An Eye-tracking Study overallStatus: RECRUITING date: 2024-03-05 date: 2025-06-01 date: 2025-07-30 date: 2024-03-25 date: 2024-04-11 name: University of Electronic Science and Technology of China class: OTHER briefSummary: The main aim of the present study is to investigate the effects of orally administered vasopressin (AVP) on the perception of time-to-collision of threatening and non-threatening stimuli by combining a validated looming fear eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: Randomized placebo-controlled double-blind between-subject design whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Vasopressin name: Placebo measure: Ratio of judged-time-to-collision to actual-time-to-collision for threatening versus non-threatening stimuli after oral vasopressin administration measure: First saccade latency(ms) for threatening versus non-threatening stimuli after oral vasopressin administration measure: Fixation duration(ms) for threatening versus non-threatening stimuli after oral vasopressin administration sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Electronic Science and Technology of China status: RECRUITING city: Chendu state: Sichuan country: China name: Weihua Zhao, Dr role: CONTACT phone: 86-28-61830811 email: zarazhao.uestc@outlook.com hasResults: False

 nctId: NCT06329050 id: BAM_lab_eyetracking_02 briefTitle: The Effects of Losartan on Attention Control: An Eye-tracking Study overallStatus: RECRUITING date: 2024-03-05 date: 2025-06-01 date: 2025-07-30 date: 2024-03-25 date: 2024-04-11 name: University of Electronic Science and Technology of China class: OTHER briefSummary: The main aim of the present study is to investigate the effects of orally administered Losartan on bottom-up and top-down attentional control to socio-emotional stimuli by combining a validated saccade/antisaccade eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Losartan name: Placebo measure: Saccade/antisaccade latency difference between social and non-social stimuli after losartan administration measure: Error rate of saccade/antisaccade for social versus non-social stimuli after losartan administration measure: Saccade/antisaccade latency for different facial emotions after losartan administration measure: Error rate of saccade/antisaccade for different facial emotions after losartan administration sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Electronic Science and Technology of China status: RECRUITING city: Chengdu state: Sichuan zip: 611731 country: China name: Weihua Zhao, Dr role: CONTACT phone: 86-28-61830811 email: zarazhao.uestc@outlook.com lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06329037 id: BAM_lab_eye-tracking_01 briefTitle: The Effects of Oral Vasopressin on Attention Control: An Eye-tracking Study overallStatus: RECRUITING date: 2024-03-05 date: 2025-06-01 date: 2025-07-30 date: 2024-03-25 date: 2024-04-11 name: University of Electronic Science and Technology of China class: OTHER briefSummary: The main aim of the present study is to investigate the effects of orally administered vasopressin (AVP) on bottom-up and top-down attentional control to socio-emotional stimuli by combining a validated saccade/antisaccade eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized placebo-controlled double-blind between-subject design primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Vasopressin name: Placebo measure: Saccade/antisaccade latency difference between social and non-social stimuli after oral vasopressin administration measure: Error rate of saccade/antisaccade for social versus non-social stimuli after oral vasopressin administration measure: Saccade/antisaccade latency for different facial emotions after oral vasopressin administration measure: Error rate of saccade/antisaccade for different facial emotions after oral vasopressin administration sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Electronic Science and Technology of China status: RECRUITING city: Chengdu state: Sichuan zip: 611731 country: China name: Weihua Zhao, Dr role: CONTACT phone: 86-28-61830811 email: zarazhao.uestc@outlook.com lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06329024 id: myofascial dysphagiapoststrok briefTitle: The Impact of Myofascial Release Therapy on Dysphagia in Post-stroke Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Stroke Survivors. The main question it aims to answer is:

• Can Myofascial Release Therapy improve swallowing function in Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Rehabilitation treatment name: Myofascial Release Therapy measure: Penetration-Aspiration Scale measure: Swallowing Quality of Life questionnaire measure: Patient health questionnaire-9 measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06329011 id: TDC+IOE briefTitle: Combining Transcranial Direct Current Stimulation With Intermittent Oral to Esophageal Tube for Stroke-related Dysphagia overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Comprehensive rehabilitation therapy name: Intermittent Oro-esophageal Tube Feeding name: Transcranial direct current stimulation name: Placebo Transcranial direct current stimulation measure: Penetration Aspiration Scale measure: Functional Oral Intake Scale measure: Swallowing Quality of Life Questionnaire measure: Patient Health Questionnaire-9 measure: Body weight sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328998 id: Intra-articular Injection briefTitle: Intra-articular Injection Versus Normal Rehabilitation Therapy on Temporomandibular Joint Dysfunction overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to study about the clinical effect of Intra-articular Injection on Temporomandibular Joint Dysfunction

The main question it aims to answer is:

• Can Intra-articular Injection help improve the Temporomandibular Joint Dysfunction Participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. The experimental group will be given Intra-articular Injection additionally, The study lasts 15 days for each patient. Researchers will compare the assessments between the two groups to see if Intra-articular Injection can help improve the Temporomandibular Joint Dysfunction conditions: Temporomandibular Joint Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Routine rehabilitation treatment name: Intra-articular Injection name: Lidocaine Hydrochloride measure: Friction Index measure: The Visual Analog Scale measure: The maximum mouth opening limit measure: Mann Assessment of Swallowing Ability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328985 id: IOETraumatic Brain Injury briefTitle: Intermittent Oro-esophageal Tube Feeding in Traumatic Brain Injury Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding or the control group with Nasogastric tube feeding for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Rehabilitation therapy name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric tube feeding measure: Concentration of hemoglobin measure: Concentration of albumin measure: Concentration of prealbumin measure: body mass index measure: Decannulation of tracheostomy tube-placement duration measure: Decannulation of tracheostomy tube-Successful removal measure: Level of consciousness measure: Feeding Amount sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328972 id: IOE-Cerebral Palsy briefTitle: Intermittent Multifunctional Nutrition Tube in Cerebral Palsy and Dysphagia overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding , n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: systemic therapy name: Intermittent Oro-Esophageal Tube Feeding name: Persistent Nasogastric Tube Feeding measure: The Oral Motor Assessment Scale measure: Pneumonia measure: Hemoglobin measure: Total Protein measure: Albumin measure: Prealbumin measure: body weight measure: Penetration-Aspiration Scale measure: Functional Oral Intake Scale for Infants measure: Feeding amount sex: ALL minimumAge: 6 Months maximumAge: 12 Months stdAges: CHILD hasResults: False

 nctId: NCT06328959 id: IOE- Pierre Robin briefTitle: Effect of Oral Feeding in Infants With Pierre Robin Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding) and the PNG group (with Nasogastric Tube Feeding), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared. conditions: Pierre Robin Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: intermittent oro-esophageal tube feeding name: gastric tube feeding measure: Number of patients diagnosed as the pulmonary infection "Positive" measure: Concentration of total protein measure: Concentration of hemoglobin measure: Concentration of albumin measure: Body weight measure: The Functional Oral Intake Scale for Infants sex: ALL minimumAge: 1 Month maximumAge: 12 Months stdAges: CHILD hasResults: False

 nctId: NCT06328946 id: IOE intracerebral hemorrhage briefTitle: The Impact of Different Feeding Modes on Patients With Intracerebral Hemorrhage overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: This was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with Intracerebral Hemorrhage.The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding vs Nasogastric Tube Feeding in Tracheostomized Patients with Intracerebral Hemorrhage. The main questions it aims to answer are:

Compared to Nasogastric Tube Feeding, can the Intermittent Oro-esophageal Tube Feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of Patients with Intracerebral Hemorrhage Compared to Nasogastric Tube Feeding, is the Intermittent Oro-esophageal Tube Feeding safer.

Participants will be divided into two groups randomly, with different nutritional support respectively. conditions: Intracerebral Hemorrhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Basic treatment name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding measure: Number of cases of successful extubation measure: Body mass index measure: Concentration of Serum albumin measure: Concentration of Hemoglobin measure: Clinical Pulmonary Infection Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328933 id: IOE feeding amount briefTitle: Intermittent Oral Tube on Feeding Amount overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to compare the differences in feeding amount and nutritional status between ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to Nasogastric Tube conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Nasogastric Tube Feeding name: Intermittent Oro-esophageal Tube Feeding name: comprehensive rehabilitation therapy measure: Nutritional status-total protein measure: Nutritional status-hemoglobin measure: Nutritional status-albumin measure: Nutritional status-prealbumin measure: Feeding Amount measure: Body weight measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328920 id: IOE Yicongxing briefTitle: Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance for Stroke overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding measure: Rehabilitation Treatment Compliance Questionnaire measure: Patient Health Questionnaire-9 measure: Swallowing Quality of Life questionnaire sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328907 id: IOE Social Condition briefTitle: Multifunctional Nutrition Tube on Social Condition and Experience in Cerebralvascular Accident overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The aim of this clinical trial is to compare the psychological condition and experience of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare the Social Condition and experience of the two groups. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: comprehensive rehabilitation therapy name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding measure: Swallowing-Quality of Life questionnaire measure: The Reintegration to Normal Living Index measure: Functional Oral Intake Scale measure: Patient Health Questionnaire-9 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328894 id: IOE Psychological briefTitle: Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to compare the differences on Psychological Condition and Experience in ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare Psychological Condition and Experience of two groups. conditions: Ischemic Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Nasogastric Tube Feeding name: Intermittent Oro-esophageal Tube Feeding name: comprehensive rehabilitation therapy measure: Generalized Anxiety Disorder 7 measure: Patient Health Questionnaire-9 measure: Self-made questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328881 id: IOE Parkinson briefTitle: Effect of Intermittent Oral Tube on Dysphagia in Parkinson's Disease Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this or clinical trial is to explore Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:

• Can stellate ganglion block improve the nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease, better than Nasogastric Tube Feeding.

Participants will be divided into the control group and observation group evenly. All the patients were provided with routine therapy and given nutritional support by Intermittent Oro-esophageal Tube Feeding and Nasogastric Tube Feeding respectively. The nutritional status, swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Comprehensive rehabilitation training name: Intermittent Oro-esophageal Tube name: Nasogastric tube measure: Concentration of Serum albumin measure: Concentration of Hemoglobin measure: Modified Barthel Index measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328868 id: IOE Nasopharyngeal Carcinoma briefTitle: Multifunctional Nutrition Tube in Dysphagia for Nasopharyngeal Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared.

Palliation to delayed dysphagia after radiotherapy for nasopharyngeal carcinoma (NPC) continues to be a challenge. Although nasogastric tube feeding (NGT) has been adopted widely, the weaknesses have yet to be improved by another enteral nutrition support mode. This study aims to observe the clinical efficacy of intermittent oro-esophageal tube feeding (IOE) in the treatment of delayed dysphagia after radiotherapy for (NPC). This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Intermittent Oral-esophageal Tube Feeding name: Nasogastric Tube Feeding name: comprehensive rehabilitation therapy measure: Concentration of Hemoglobin measure: Concentration of Serum albumin measure: Body Mass Index measure: Concentration of Serum prealbumin measure: Depression measure: Functional Oral Intake Scale measure: Penetration-Aspiration Scale measure: Swallowing-Quality of Life questionnaire measure: Feeding amount sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328855 id: IOE Dysphagia in Stroke briefTitle: Intermittent Oro-esophageal Tube Feeding on Dysphagia in Stroke Survivor overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding and nasogastric tube feeding, respectively. Nutritional status, dysphagia, quality of life and depression before and after treatment were compared. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Intermittent Oro-esophageal Tube Feeding name: comprehensive rehabilitation therapy name: Nasogastric Tube Feeding measure: Penetration-Aspiration Scale measure: Body weight measure: Nutritional status-total protein measure: Nutritional status-albumin measure: Yale pharyngeal residue severity rating scale measure: Patient health questionnaire-9 measure: Swallowing Quality of Life questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328842 id: IOE Cerebral Small Vessel briefTitle: Effect of Multifunctional Nutrition Tube on Cerebral Small Vessel Disease Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach. conditions: Cerebral Small Vessel Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 88 type: ESTIMATED name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding measure: Video Fluoroscopic Swallowing Study measure: Functional Oral Intake Scale measure: Body mass index measure: Pneumonia measure: Activities of daily living measure: World Health Organization Quality of Life Assessment Instrument Brief Version sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328829 id: IOE Alzheimer briefTitle: Intermittent Oral Tube in Alzheimer's Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Conventional Care name: Intermittent Oral-esophageal Tube Feeding name: Nasogastric tube measure: Concentration of Hemoglobin measure: Concentration of Serum albumin measure: Concentration of Total serum protein measure: Concentration of Serum prealbumin measure: Body Mass Index measure: Pulmonary Infections measure: Mini Nutritional Assessment measure: Standardized Swallowing Assessment sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328816 id: Computer-based Training briefTitle: Computer-based Training on Cognitive Dysphagia in Stroke Survivors overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: This is a multicenter randomized controlled study. The study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland China as the participants (study subjects). The study duration for each participant was 15 days. The subjects were randomly divided into an experimental group and a control group. During the treatment, all patients received routine rehabilitation treatment. In addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: routine rehabilitation treatment name: Computer-assisted Cognitive Function Training measure: Montreal Cognitive Assessment measure: The coordination of swallowing measure: Penetration-Aspiration Scale measure: Swallowing reflex sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328803 id: Active Breathing Exercises briefTitle: Impact of Active Breathing Exercises on Respiratory Rhythm Disorders in Stroke Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation training name: Active Breathing Exercises measure: Penetration-Aspiration Scale measure: Functional Oral Intake Scale measure: Yale Pharyngeal Residue Severity Rating Scale measure: Fiberoptic Endoscopic Dysphagia Severity Scale measure: Murray Secretion Scale measure: Swallowing Quality of Life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328790 id: PNRR-MAD-2022-12376826 briefTitle: Study of Biomorkers and Rehabilitation Strategies in Functional Motor Disorders (FMD) overallStatus: RECRUITING date: 2023-05-31 date: 2025-05 date: 2025-05 date: 2024-03-25 date: 2024-03-26 name: Michele Tinazzi, MD, PhD class: OTHER name: IRCCS Ospedale San Raffaele name: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona briefSummary: Functional motor disorders (FMD) are prevalent and highly disabling conditions characterized by abnormal movements (functional weakness, tremor, dystonia) significantly altered by distractive manoeuvres and incongruent with movement disorders seen in specific neurological diseases. FMDs are still misunderstood, diagnosed with delay, and not adequately treated, leading to reduced independence and high healthcare costs. Symptoms are physiologically associated with voluntary movement (distractibility, resolution with placebo) but are reported as involuntary. How this happens is yet a matter of debate. Identifying diagnostic and prognostic disease-specific biomarkers is an unmet need. The investigators will investigate motor, exteroceptive and interoceptive domains in a large cohort of FMD patients by a comprehensive set of behavioural, neurophysiological, and MRI tests. Ad-hoc eXplainable Artificial Intelligence (XAI) methods will develop disease-specific diagnostic and prognostic biomarker algorithms. conditions: Functional Motor Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 450 type: ESTIMATED name: Multidisciplinary Rehabilitation Training name: Cross-sectional study on patients with FMD and patients with structural/organic diseases name: Cross-sectional study on patients with FMD and healthy controls (HC) measure: Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score measure: Multidimensional Fatigue Inventory Scale (MFI-20) score measure: Brief Pain Inventory (BPI) score measure: Beck Anxiety Inventory (BAI) score measure: Beck Depression Inventory (BDI-II) score measure: 12-item Short-Form Health Survey (SF-12) score measure: Toronto Alexithymia Scale (TAS-20) score measure: Direct adn indirect index of Sensory Attenuation (SA) measure: Joint angle at the elbow vibrated and reproduced measure: N2/P2 amplitude measure: Objective/Subjective heart rate ratio measure: Cortical thickness and gray matter volumes measure: Clinical Global Impression (CGI) score measure: Gait speed (cm/sec) measure: Swing time (%) measure: Stride time (s) measure: Stride length (cm) measure: Sway area (mm2) measure: Stance time (sec) measure: Total excursion path (mm) measure: Velocity of Cop displacement in the anteroposterior directions (mm/s) measure: Velocity of Cop displacement in the mediolateral directions (mm/s) measure: Autism spectrum Quotient (AQ) measure: Schizotypal Personality Questionnaire (SPQ) measure: Number of drop-out measure: Number of patients who refuse the treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona status: RECRUITING city: Salerno state: Campania zip: 84131 country: Italy name: Maria Teresa Pellecchia, PhD role: CONTACT phoneExt: +39 email: mpellecchia@unisa.it lat: 40.67545 lon: 14.79328 facility: IRCCS Ospedale San Raffaele status: RECRUITING city: Milano state: Lombardia zip: 20132 country: Italy name: Federica Agosta, PhD role: CONTACT phoneExt: +39 email: agosta.federica@hsr.it name: Elisabetta Sarasso, PhD role: CONTACT email: sarasso.elisabetta@hsr.it lat: 45.46427 lon: 9.18951 facility: Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona status: RECRUITING city: Verona zip: 37131 country: Italy name: Michele Tinazzi, PhD role: CONTACT phone: 0458124768 phoneExt: +39 email: michele.tinazzi@univr.it name: Marialuisa Gandolfi, PhD role: CONTACT phone: 3491656108 phoneExt: +39 email: marialuisa.gandolfi@univr.it lat: 45.4299 lon: 10.98444 hasResults: False

 nctId: NCT06328777 id: CAB-201-003 briefTitle: RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2029-07 date: 2029-07 date: 2024-03-25 date: 2024-04-26 name: Cabaletta Bio class: INDUSTRY briefSummary: RESET-SSc: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T cell therapy, in Subjects with Systemic Sclerosis conditions: Systemic Sclerosis conditions: Scleroderma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: CABA-201 measure: To evaluate incidence of adverse events measure: To evaluate adverse events and laboratory abnormalities measure: To characterize the pharmacodynamics (PD) measure: To characterize the pharmacokinetics (PK) measure: To evaluate efficacy sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: James St. Clair role: CONTACT phone: 734-936-5615 email: ssc-coordinator@umich.edu name: Neda Kortam role: CONTACT phone: 734-763-4866 email: ssc-coordinator@umich.edu name: Monalisa Ghosh, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06328764 id: CS-101-11 briefTitle: A Clinical Trial Evaluating the Safety and Efficacy of CS-101 in Treating Subjects With β-thalassemia overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2025-12-31 date: 2026-01-30 date: 2024-03-25 date: 2024-03-25 name: CorrectSequence Therapeutics Co., Ltd class: INDUSTRY name: First Affiliated Hospital of Guangxi Medical University briefSummary: The goal of this open label, single-arm clinical study is to learn about the safety and efficacy of CS-101 in treating β-thalassemia. conditions: Beta-Thalassemia studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: CS-101 measure: Frequency and severity of adverse events(AEs）as assessed by CTCAE v5.0 measure: Time to neutrophil and platelet engraftment measure: Proportion of subjects with engraftment measure: Incidence of transplant-related mortality measure: All-cause mortality measure: Proportion of subjects achieving transfusion independence for at least 6 consecutive months measure: Time to last red blood cell(RBC) transfusion measure: Change in total hemoglobin(Hb) concentration over time measure: Change in fetal hemoglobin(HbF) concentration over time measure: Chimerism level in Peripheral blood and bone marrow sex: ALL minimumAge: 6 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: The First Affiliated Hospital of Guangxi Medical University city: Nanning state: Guangxi country: China lat: 22.81667 lon: 108.31667 hasResults: False

 nctId: NCT06328751 id: 76043823.0.0000.0004 briefTitle: Meditation With Virtual Reality for Cancer Pain Relief in the Pain Therapy and Palliative Care Service overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2025-06-30 date: 2025-08-30 date: 2024-03-25 date: 2024-03-25 name: Emily Santos Montarroyos class: NETWORK name: AC Camargo Cancer Center briefSummary: Cancer is a disabling, challenging and growing global disease. Although early diagnosis and adequate treatment of oncological disease have been developing rapidly, a large part of the population remains without access to specialized services and routinely evolve to symptoms and sequelae with uncontrolled pain, worse quality of life and suffering. Complementary therapies to control pain and improve the well-being of cancer patients are fundamental tools of integrative oncology medicine. This study proposes to use immersive virtual reality to encourage cancer patients to carry out the regular practice of meditation, as an effective tool in pain management and in the search for a better quality of life, based on a structured intervention that encourages autonomy as important part of your treatment. Two studies will be carried out at the Pain Therapy and Palliative Care Service of the Amazonas State Oncology Control Center Foundation (FCECON). Study 1 will be a cross-sectional study to describe the variables associated with the diagnosis and treatment of patients' pain and Study 2 will be a Randomized Controlled Trial that will analyze the impact of an intervention performed with meditation through immersive virtual reality for pain relief. pain in these patients. It is expected that the regular practice of meditation through immersive virtual reality will promote pain relief and improve the quality of life of cancer pain patients. conditions: Cancer Pain conditions: Quality of Life conditions: Palliative Medicine studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective, experimental, longitudinal, randomized controlled trial (RCT), carried out in three stages. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Randomization will be carried out using a specific application called Randomizer ® for Clinical Trial Lite, which is a secure and validated application that works with encrypted network traffic using Transport Layer Security (TLS), a strong encryption. There will be 3 groups which will be divided into the Case Group, the Active Control Group and the Passive Control Group. Each patient will be seen individually wearing a Samsung® smartwatch and will not know about the other patients' meditation. The case group will watch a 7-minute immersive virtual reality video of mindfulness meditation with image and sound in the Oncology Control Center Foundation (FCECON) office, using Samsung® gear VR virtual reality glasses. The active control group will watch a 7-minute mindfulness meditation video presented via cell phone with image and sound at the office. The passive control group will perform breathing exercises based on the healthcare professional's instructions for 4 minutes in the office. whoMasked: PARTICIPANT count: 129 type: ESTIMATED name: Case group name: Active control group name: Passive control group measure: Brief Pain Inventory (Reduced version) measure: McGill Quality of Life Questionnaire measure: Hospital Anxiety and Depression Scale (HADS) measure: The Edmonton Symptom Assessment Scale (ESAS) measure: The National Comprehensive Cancer Network® (NCCN) Distress Thermometer sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328738 id: ELVN-002-003 briefTitle: ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer overallStatus: RECRUITING date: 2024-06-01 date: 2027-01 date: 2028-07 date: 2024-03-25 date: 2024-03-26 name: Enliven Therapeutics class: INDUSTRY briefSummary: The purpose of this study is to determine the safety, tolerability, and recommended dose of ELVN-002 in combination with trastuzumab in participants with advanced-stage HER2-positive tumors and in combination with trastuzumab, and chemotherapy in participants with advanced-stage HER2-positive colorectal cancer and breast cancer. conditions: HER2-positive Breast Cancer conditions: HER2-positive Gastric Cancer conditions: HER2 Positive Solid Tumors conditions: HER2 Amplification conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Phase 1a will be a dose escalation of ELVN-002 in combination with fixed doses of trastuzumab or trastuzumab + chemotherapy according to the Bayesian Optimal Interval Design model. Phase 1b will be a dose expansion at one or more doses of ELVN-002. primaryPurpose: TREATMENT masking: NONE count: 255 type: ESTIMATED name: ELVN-002 name: Trastuzumab name: 5-Fluorouracil name: Oxaliplatin name: Capecitabine name: Eribulin name: paclitaxel name: Leucovorin measure: Incidence of dose limiting toxicities (DLTs; Phase 1a only) measure: Incidence of adverse events (AEs) measure: Incidence of laboratory abnormalities measure: Incidence of electrocardiogram abnormalities measure: PK parameter of area under the curve of ELVN-002 (Phase 1a only) measure: PK parameter of maximum concentration of ELVN-002 (Phase 1a only) measure: PK parameter of minimum concentration of ELVN-002 (Phase 1a only) measure: PK parameter of terminal half life of ELVN-002 (Phase 1a only) measure: Confirmed objective response rate (ORR) measure: Duration of response (DOR; Phase 1b only) measure: Brain metastases response (Phase 1b only) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NEXT Virginia status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States name: Alexander Spira, MD role: CONTACT phone: 703-636-1473 lat: 38.84622 lon: -77.30637 hasResults: False

 nctId: NCT06328725 id: EN001_POWER briefTitle: Evaluate the Efficacy and Safety of EN001 in Patients With Duchenne Muscular Dystrophy overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-11 date: 2025-11 date: 2024-03-25 date: 2024-03-25 name: ENCell class: INDUSTRY briefSummary: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 1/2 Trial to Evaluate the Efficacy and Safety of EN001 in Patients with Duchenne Muscular Dystrophy conditions: Duchenne Muscular Dystrophy studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: \<Phase 1 Clinical Trial\> A total of 6-12 participants (3-6 participants per cohort).

\<Phase 2 Clinical Trial\> A total of 76 participants (a minimum of 30 participants per group, considering a dropout rate of 20%, resulting in 38 participants per group). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The investigational drug for the clinical trial of the following cohort or group will be administered intravenously (IV) three times at 6-week intervals.

\<Phase 1 Clinical Trial\> Cohort 1: EN001 5.0x10\^5 cells/kg / Cohort 2: EN001 2.5x10\^6 cells/kg

\<Phase 2 Clinical Trial\> Experimental Group: Recommended Phase 2 Dose (RP2D) for EN001 / Control Group: Placebo for EN001 whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 88 type: ESTIMATED name: EN001 measure: <Phase 1> Adverse drug reactions related to dose limiting toxicity (DLT) measure: <Phase 1> Adverse drug reactions related to discontinuation of clinical trial drug administration measure: <Phase 2> Change in time to stand test (TTSTAND) measure: <Phase 1> Time to stand test (TTSTAND) change amount measure: <Phase 1> TTSTAND velocity (1/TTSTAND) change amount measure: <Phase 1> Time to run/walk 10 meters test (TTRW) change amount measure: <Phase 1> TTRW velocity (1/TTRW) change amount measure: <Phase 1> North Star Ambulatory Assessment (NSAA) change amount measure: <Phase 1> Time to climb 4 steps test (TTCLIMB) change amount measure: <Phase 1> TTCLIMB velocity (1/TTCLIMB) change amount measure: <Phase 1> 6-minute walk test (6MWT) change amount measure: <Phase 1> Changes amount in muscle strength by region measure: <Phase 1> Changes amount in parameters related to pulmonary function measure: <Phase 1> Changes amount in parameters related to cardiac function measure: <Phase 1> Change rate of creatine kinase (CK) at each visit after administration of investigational product compared to baseline (Visit 2) measure: <Phase 2> Time to stand test (TTSTAND) change amount measure: <Phase 2> TTSTAND velocity (1/TTSTAND) change amount measure: <Phase 2> Time to run/walk 10 meters test (TTRW) change amount measure: <Phase 2> TTRW velocity (1/TTRW) change amount measure: <Phase 2> North Star Ambulatory Assessment (NSAA) change amount measure: <Phase 2> Time to climb 4 steps test (TTCLIMB) change measure: <Phase 2> TTCLIMB velocity (1/TTCLIMB) change amount measure: <Phase 2> 6-minute walk test (6MWT) change amount measure: <Phase 2> Changes amount in muscle strength by region measure: <Phase 2> Changes amount and rate of change in whole thigh muscle volume and index assessed by MRI measure: <Phase 2> Changes amount in parameters related to pulmonary function measure: <Phase 2> Changes amount in parameters related to cardiac function measure: <Phase 2> Change rate of creatine kinase (CK) at each visit after administration of investigational product compared to baseline (Visit 2) measure: <Phase 2> Pediatric Outcomes Data Collection Instrument (PODCI) item score and total score change measure: <Phase 2> Pediatric Quality of Life inventory™ (PedsQL™) item scores and total score change measure: <Phase 1> Adverse Event measure: <Phase 1> Laboratory examination measure: <Phase 1> Vital sign measure: <Phase 2> Adverse Event measure: <Phase 2> Laboratory examination measure: <Phase 2> Vital sign sex: MALE minimumAge: 6 Years maximumAge: 11 Years stdAges: CHILD facility: Samsung Medical Center city: Seoul country: Korea, Republic of name: Jeehun Lee role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Seoul National University Hospital city: Seoul country: Korea, Republic of name: Jong-Hee Chae role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06328712 id: EN001_MIRACLE1 briefTitle: Evaluate the Safety and Efficacy of EN001 in Patients With Charcot-Marie-Tooth Disease Type 1A overallStatus: RECRUITING date: 2024-03 date: 2024-10 date: 2024-10 date: 2024-03-25 date: 2024-03-25 name: ENCell class: INDUSTRY briefSummary: An Open, Dose-escalation, Phase 1b Clinical Trial to Evaluate the Safety and Efficacy of EN001 in Patients with Charcot-Marie-Tooth Disease type 1A (CMT1A) conditions: Charcot-Marie-Tooth Disease Type 1A studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: EN001 measure: Dose limiting toxicity (DLT) and adverse drug reactions related to discontinuation of investigational product administration measure: CMTNSv2 score change measure: CMT examination score change measure: Rasch-modified CMTNSv2 score change measure: Rasch-modified CMTES score change measure: FDS score change measure: ONLS score change measure: 10MWT score change measure: Change in grade of fatty infiltration in the proximal lower extremities (According to Goutallier classification scale) measure: Change in Motor Nerve Conduction Velocity (Unit: m/s) measure: Change in Compound Muscle Action Potential (Unit: ㎷) measure: Change in Sensory Nerve Action Potential (Unit: ㎶) measure: Change in Sensory Nerve Conduction Velocity (Unit: m/s) measure: SF-36v2 score change measure: Adverse Event measure: Vital sign measure: Laboratory examination measure: electrocardiography measure: X-ray measure: Physical Examinations sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center status: RECRUITING city: Seoul country: Korea, Republic of name: Byung-Ok Choi role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06328699 id: STUDY00006456 id: EU6011-23 type: OTHER domain: Emory University Hospital/Winship Cancer Institute id: K01AT010488 type: NIH link: https://reporter.nih.gov/quickSearch/K01AT010488 id: P30CA138292 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA138292 briefTitle: Chaplain-Delivered Compassion Meditation to Improve Spiritual Care of Patients Receiving Stem Cell Transplantation overallStatus: RECRUITING date: 2023-10-30 date: 2024-05-01 date: 2024-11-15 date: 2024-03-25 date: 2024-04-01 name: Emory University class: OTHER name: National Cancer Institute (NCI) name: National Center for Complementary and Integrative Health (NCCIH) briefSummary: This clinical trial tests the feasibility, implementation and acceptability of chaplain delivered compassion meditation in order to improve spiritual care for patients receiving stem cell transplantation. Hospital chaplains play a vital role in delivering emotional and spiritual care to a broad range of both religious and non-religious patients for a wide variety of stressors, and extensive research indicates that spiritual consults impact patient outcomes and satisfaction. Compassion meditation is a secularized, research-based mindfulness and compassion meditation program designed to expand and strengthen compassion for self and others. Practices include training in attentional stability and increased emotional awareness, as well as targeted reflections to appreciate one's relationship with self and others. By centering the mind, controlling debilitating ruminative thoughts, and cultivating personal resiliency and an inclusive and more accurate understanding of others. Engaging in chaplain delivered compassion meditation may improve the spiritual care for patients receiving stem cell transplantation. conditions: Lymphoma conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: Spiritual Therapy name: Best Practice measure: Feasibility - patient enrollment and treatment-specific retention rates measure: Patient Characteristics Affecting Acceptability - Chaplain Satisfaction Survey measure: Functional Assessment of Cancer Therapy-Bone Marrow Transplant [FACT-BMT] measure: Acceptability - Chaplain Satisfaction Survey sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emory University Hospital/Winship Cancer Institute status: RECRUITING city: Atlanta state: Georgia zip: 30322 country: United States name: Erin Brauer, MPH role: CONTACT email: erin.graf.brauer@emory.edu lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06328686 id: STUDY00005787 id: NCI-2023-10895 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: STUDY00005787 type: OTHER domain: Emory University Hospital/Winship Cancer Institute id: WINSHIP5883-23 type: OTHER domain: Emory University Hospital/Winship Cancer Institute id: P30CA138292 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA138292 briefTitle: Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2025-12-31 date: 2026-12-31 date: 2024-03-25 date: 2024-04-19 name: Emory University class: OTHER name: National Cancer Institute (NCI) briefSummary: This early phase I trial evaluates different administration techniques (oral or intravenous) for arginine and tests the safety of giving arginine with whole brain radiation therapy in patients who have cancer that has spread from where it first started (primary site) to the brain (brain metastases). Arginine is an essential amino acid. Amino acids are the molecules that join together to form proteins in the body. Arginine supplementation has been shown to improve how brain metastases respond to radiation therapy. The optimal dosing of arginine for this purpose has not been determined. This study measures the level of arginine in the blood with oral and intravenous dosing at specific time intervals before and after drug administration to determine the best dosing strategy. conditions: Metastatic Malignant Neoplasm in the Brain conditions: Metastatic Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Arginine name: Biospecimen Collection name: Computed Tomography name: Magnetic Resonance Imaging name: Spectroscopy name: Whole-Brain Radiotherapy measure: Peak plasma L-arginine (arginine) and arginine metabolite concentration measure: Incidence of adverse events associated with delivering L-arginine with standard fractionation whole brain radiation therapy measure: Side effect profile of oral and IV arginine measure: Frontal cortex blood volume/flow changes with L-arginine administration measure: Describe The Immunological Effects of Oral versus IV Arginine measure: Describe The Metabolic Effects of Oral versus IV Arginine sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emory University Hospital/Winship Cancer Institute city: Atlanta state: Georgia zip: 30322 country: United States name: Lisa Sudmeier, MD, PhD role: CONTACT phone: 404-712-9625 email: lsudmei@emory.edu name: Agnes Harutyunyan role: CONTACT email: aharuty@emory.edu name: Lisa Sudmeier, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06328673 id: DM919-001 briefTitle: A Study of DM919 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors overallStatus: RECRUITING date: 2024-03-01 date: 2025-12-01 date: 2026-03-01 date: 2024-03-25 date: 2024-03-28 name: D2M Biotherapeutics Inc. class: INDUSTRY briefSummary: The goal of this clinical trial is to define a safe and effective dose of DM919 for participants with solid tumors

The main questions it aims to answer are:

What is the safe and effective dose of DM919 when used alone or in combination with pembrolizumab? What cancers can be treated effectively with DM919 alone or in combination with pembrolizumab??

Participants will be asked to attend clinic and be given a intravenous infusion of DM919 or DM-919 in combination with pembrolizumab. They will have blood tests and other assessments to measure whether DM-919 will have the effect on tumors. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 160 type: ESTIMATED name: DM919 name: Pembrolizumab measure: Number of treatment-emergent events (TEAEs) in Dose Escalation measure: RDEs or RP2Ds of DM919 alone and in combination with pembrolizumab measure: All cohorts measure: All cohorts measure: All cohorts measure: All cohorts measure: Dose Expansion measure: Dose Expansion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NEXT Oncology status: RECRUITING city: San Antonio state: Texas zip: 78216 country: United States name: Shiraj Sen role: CONTACT phone: 972-893-8800 lat: 29.42412 lon: -98.49363 hasResults: False

 nctId: NCT06328660 id: EX-MKTG-155 briefTitle: Refitting Multifocal Contact Lens Wearers With a Different Multifocal Contact Lens overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-15 date: 2024-06-18 date: 2024-06-18 date: 2024-03-25 date: 2024-03-25 name: Coopervision, Inc. class: INDUSTRY briefSummary: The purpose of this study is to compare ease of handling and vision acuity of two multifocal contact lenses to correct presbyopia that are currently CE marked and on the UK market. conditions: Presbyopia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 66 type: ACTUAL name: Lens 1 name: Lens 2 measure: Overall Lens Handling measure: Overall logMAR Visual Acuity sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ocular Technology Group city: London zip: SW1E6AU country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06328647 id: 24-010 briefTitle: Quantra Point-of-Care Hemostasis Monitoring acronym: QUANTRA overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-25 date: 2024-04-23 name: The Cleveland Clinic class: OTHER briefSummary: The investigators will test the hypothesis that utilization of a blood and blood component transfusion algorithm guided by the POC Quantra QPlus System in patients undergoing complex cardiac surgery will reduce RBC, plasma, cryoprecipitate, and platelet transfusion during surgery and the first 12 postoperative hours, compared to standard of care (central laboratory transfusion monitoring at the primary anesthesia provider's discretion). conditions: Bleeding conditions: Hemostatic Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Clinical Trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Patients and outcome assessor will be masked to the group allocation. Clinicians will be unmasked to group allocation. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 666 type: ESTIMATED name: POC Quantra QPlus System name: Routine care measure: Blood and blood component transfusions measure: Bleeding measure: PT/aPTT measure: INR measure: Platelet measure: Fibrinogen measure: hematocrit/hemoglobin measure: ICU length of stay measure: Hospital length of stay. measure: In-hospital mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328634 id: LOCAL/2014/FV-01 briefTitle: Bacillus Cereus Infection of Patients Diagnosed at Nîmes University Hospital overallStatus: COMPLETED date: 2008-01-01 date: 2012-12-31 date: 2012-12-31 date: 2024-03-25 date: 2024-03-25 name: Centre Hospitalier Universitaire de Nīmes class: OTHER briefSummary: OBJECTIVES:

We aimed to study the characteristics of patients presenting with a Bacillus cereus infection in a university hospital.

METHODS:

We performed a retrospective analysis of the clinical, biological, and treatment-related data of patients hospitalized in our university hospital between January 1st, 2008 and December 31st, 2012 and diagnosed with a B. cereus infection. We identified a subgroup of patients presenting with bacteremia and looked for risk factors for death within that group of patients. conditions: Bacillus Cereus Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 76 type: ACTUAL measure: descriptive analysis of patients' characteristics and B. cereus infection or colonization. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328621 id: 19594 id: NCI-2021-05881 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 19594 type: OTHER domain: City of Hope Medical Center id: P30CA033572 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA033572 briefTitle: Lung Cancer Risk Assessment and Etiology overallStatus: RECRUITING date: 2021-07-02 date: 2029-06-15 date: 2029-06-15 date: 2024-03-25 date: 2024-03-25 name: City of Hope Medical Center class: OTHER name: National Cancer Institute (NCI) briefSummary: This study examines the biological and social determinants that may increase the risk for lung cancer in patients and never-smoking individuals. Biological characteristics of a person can include their genetics and social determinants of a person can include their education, income, and environment, all of which can impact their health. Information collected in this study may help increase early detection of lung cancer. conditions: Lung Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Biospecimen Collection name: Computed Tomography name: Electronic Health Record Review name: Survey Administration measure: Frequency of germline alterations measure: Frequency of abnormal radiographic findings measure: Associations between molecular phenotypes, social determinants of health, and the presence of lung cancer and related outcomes measure: Liquid biopsy (LB) test sensitivity measure: LB test specificity measure: LB test positive predictive value measure: LB test negative predictive value measure: LB test accuracy comparing LB genetic mutations to those found on next generation sequencing (NGS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope Medical Center status: RECRUITING city: Duarte state: California zip: 91010 country: United States name: Stacy W. Gray role: CONTACT phone: 626-218-6639 email: stagray@coh.org name: Stacy W. Gray role: PRINCIPAL_INVESTIGATOR lat: 34.13945 lon: -117.97729 hasResults: False

 nctId: NCT06328608 id: CLI-06657AA1-01 id: 2022-503128-29 type: REGISTRY domain: Clinical Trial Information System (CTIS) - EU briefTitle: A Study to Learn About the Safety and Effects of the Study Drug PRX-102 in Children and Adolescents With Fabry Disease acronym: FLY overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2027-12 date: 2028-03 date: 2024-03-25 date: 2024-03-25 name: Chiesi Farmaceutici S.p.A. class: INDUSTRY name: ICON plc briefSummary: A Study to Learn About the Safety and Effects of the Study Drug PRX-102 in Children and Adolescents with Fabry Disease. conditions: Fabry Disease studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: PRX-102 1 mg/kg every two weeks measure: Incidence of Treatment Emergent Adverse Events (TEAEs) measure: Incidence of Infusion Related Reactions (IRRs) measure: Incidence of Injection site reactions (ISRs) measure: Change in Tanner stage measure: Change from baseline of 12-lead ECG quantitative parameters: Mean Heart Rate measure: Change from baseline of 12-lead ECG quantitative parameters: PR Interval measure: Change from baseline of 12-lead ECG quantitative parameters: QRS Duration measure: Change from baseline of 12-lead ECG quantitative parameters: QT Interval measure: Change from baseline of 12-lead ECG quantitative parameters: QTc Interval measure: Change from baseline of 12-lead ECG quantitative parameters: ST Segment measure: Incidence of treatment-emergent Anti-Drug Antibodies (ADAs) measure: Incidence of premedication use at each visit and change of infusion premedications from baseline measure: Pharmacokinetics: Time to maximum plasma concentration (tmax) measure: Pharmacokinetic : Area under the plasma concentration-time curve from time 0 to time t (AUC0 t) measure: Pharmacokinetics: Area under the curve from time 0 to 2 weeks (AUC0-2wk) measure: Pharmacokinetics: Area under the curve from time 0 to infinity (AUC0-∞) measure: Pharmacokinetics: Terminal half-life (t1/2) measure: Pharmacokinetics: Area under the curve over a dosing interval (AUCτ) measure: Pharmacokinetics: Observed drug concentration at the end of the dosing interval (Cτ) measure: Pharmacokinetics: Clearance (Cl) measure: Pharmacokinetics: Volume of distribution (Vz) measure: Change in eGFR measure: Change in annualized eGFR slope measure: Change in urine albumin levels measure: Change in urine protein levels measure: Change from baseline in LVMi as assessed by echocardiogram measure: Change from baseline in LVMi as assessed by echocardiogram measure: Change from baseline in LVMi as assessed by echocardiogram measure: Change from baseline in LVMi as assessed by echocardiogram measure: Change from baseline in LVMi as assessed by echocardiogram measure: Incidence of any cardiac arrythmias as assessed by Holter ECG measure: Change in plasma levels of cardiac biomarkers measure: Change in plasma level of Gb3 concentration (nM) measure: Change in plasma level of lyso-Gb3 (nM) measure: Change in urine level of lyso-Gb3 (nM) measure: Incidence of change from baseline in the number of different pain medications measure: Incidence of Fabry Clinical Events measure: Change from baseline of Mainz Severity Score Index (MSSI) scores measure: Change from baseline of PedsQL-GI (or GSRS for subjects who reaches 18 yrs of age) scores measure: Change from baseline of FPHPQ scores measure: Change from baseline of PedsQL-PPQ (or BPI-SF for subjects who reaches 18 yrs of age) scores measure: Change from baseline of EQ-5D-Y (or EQ-5D-5L for subjects who reaches 18 yrs of age) scores sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06328595 id: Cross sectional briefTitle: Muscular and Joint Symptoms in COVID-19 Patients: Insights From Syria overallStatus: COMPLETED date: 2022-04-22 date: 2023-05-04 date: 2023-08-20 date: 2024-03-25 date: 2024-03-26 name: Syrian Private University class: OTHER briefSummary: Observation study, shows the relation between musckeloskeletal symptoms with during and post Covid-19 infection, by asking participants questions about there age,job,which vaccination covid participants took, residual area, social status, number of time of covid-19 infection, number of joint affected and duration of joint pain and asking if there any malaise or fatigue conditions: Musculoskeletal Pain conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 1039 type: ACTUAL measure: The Demographic characteristics were classified into four groups: Gender, Residual area, education level. sex: ALL minimumAge: 18 Years maximumAge: 78 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mohamad Zaid Ahmad Abdalla city: Damascus country: Syrian Arab Republic lat: 33.5102 lon: 36.29128 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-09-24 uploadDate: 2024-03-22T04:16 filename: Prot_SAP_000.pdf size: 235804 hasResults: False

 nctId: NCT06328582 id: Zhenjiu Post-stroke dysphagia briefTitle: Acupuncture Technique for Restoring Consciousness on Post-stroke Dysphagia overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: This is a randomized controlled study, including post-stroke dysphagic patients. The participants were divided randomly into the experimental group and the control group. Both two groups were given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given Acupuncture Technique for Restoring Consciousness. Swallowing function will be compared before and after treatment. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Routine rehabilitation training name: Acupuncture Technique for Restoring Consciousness combined with Scalp Acupuncture measure: Penetration-Aspiration Scale measure: Functional Oral Intake Scale measure: Gugging Swallowing Screen sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328569 id: VR Wallenberg Syndrome briefTitle: Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. The main questions it aims to answer are:

the efficacy of Virtual Reality Therapy in the rehabilitation of patients with dysphagia in Wallenberg syndrome.

Participants received conventional dysphagia treatment and Virtual Reality Therapy once a day for 14 days. Researchers compared the control group to see the effect and mechanism of Virtual Reality Therapy. conditions: Wallenberg Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Virtual Reality Therapy name: Conventional dysphagia treatment measure: standardized swallowing assessment measure: Murray secretion scale measure: penetration-aspiration scale measure: swallowing-quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328556 id: Ultrasound-guided Botulinum briefTitle: Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: Ultrasound-guided injection is a visual, convenient, and radiation-free technique that allows real-time observation of the needle insertion process and drug injection location. The combination with a balloon for fixation further enhances the precision of the injection. In this study, the investigators employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations. conditions: Cricopharyngeal Achalasia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: botulinum toxin type A name: Injection measure: functional oral intake scale measure: Penetration-Aspiration Scale measure: The Fiberoptic Endoscopic Dysphagia Severity Scale measure: Murray secretion scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328543 id: N-20210046 4th project briefTitle: Itch Sensation Induced by Multiple Applications of Pruritogens (Temporal Summation) overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2026-12-31 date: 2024-03-25 date: 2024-03-25 name: Aalborg University class: OTHER briefSummary: In This experiment, the investigators would like to design a new itch model based on the temporal summation of pruritic stimuli. The hypothesis behind this study (temporal summation) is that two overlapped applications of pruritogens will result in a higher itch sensation compared with a single application. conditions: Histamine conditions: Cowhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: The participants will randomly receive applications of cowhage and histamine primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Participant will be blinded about application of pruritogens whoMasked: PARTICIPANT count: 26 type: ESTIMATED name: Histamine name: Cowhage measure: Assessment of itch measure: Assessment of pain measure: Microvascular reactivity measure: Alloknesis measure: Mechanically evoked itch sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06328530 id: N-20210046 3rd project briefTitle: Itch Sensation Induced by Simultaneous Application of Pruritogens (Spatial Summation) overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2026-12-31 date: 2024-03-25 date: 2024-03-25 name: Aalborg University class: OTHER briefSummary: In This experiment, the investigators would like to design a new itch model based on the spatial summation of pruritic stimuli. The hypothesis behind this study (spatial summation) is that two simultaneous applications of pruritogens will result in higher itch sensation compared with a single application of pruritogen. conditions: Histamine conditions: Cowhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: The participants will randomly receive applications of cowhage and histamine. primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Participant will be blinded about application of pruritogens. whoMasked: PARTICIPANT count: 24 type: ESTIMATED name: Cowhage name: Histamine measure: Assessment of itch measure: Assessment of pain measure: Alloknesis measure: Mechanically evoked itch sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06328517 id: 2023-305 briefTitle: The Influence of Nutritional Factors on the Prognosis of Liver Cirrhosis Patients and the Exploration of Predictive Models overallStatus: RECRUITING date: 2023-11-01 date: 2026-11-01 date: 2026-11-01 date: 2024-03-25 date: 2024-03-25 name: Juan Kang class: OTHER briefSummary: Cirrhosis is a progressive developing liver disease transforming normal hepatocytes into scar tissue with loss of function.The prevalence of cirrhosis has approximately tripled over the past two decades. With the increasing incidence of chronic liver disease, about 2 million people died from cirrhosis worldwide. Currently, D'Amico stage classification and Child-Pugh and Model for End-Stage Liver Disease (MELD) scores constitute the best tools to predict mortality in patients with Cirrhosis; however, one of their main limitations is the lack of evaluation of the nutritional and functional status. Patients with End-Stage Liver Disease (ESLD) have reduced nutritional intake, hypermetabolism, increased energy expenditure, impaired fasting adaptability, decreased hepatic glycogen reserves, and increased consumption of protein as the main energy donor that often lead to malnutrition, therefore, malnutrition is one of the most common complications in patients with Cirrhosis, is closely related to the increase in morbidity and mortality. Moreover, malnutrition is closely related to the high incidence of infection, ascites, hepatic encephalopathy, and hepatorenal syndrome, and is an independent risk factor affecting the survival rate of patients with End-Stage Liver Disease, including liver transplantation.

Therefore, malnutrition should be treated as equally important complications such as ascites and hepatic encephalopathy, and accurate screening, evaluation and appropriate nutritional intervention measures should be taken to improve the prognosis of patients with Cirrhosis. This study aims to establish a nomogram model about nutritional factors to predict the prognosis of patients with Cirrhosis, verify and optimize the model, through the establishment of the model, to more comprehensively evaluate and predict the prognosis of patients with Cirrhosis from the perspective of nutrition, to provide sufficient basis and lay a solid foundation for further nutritional intervention and improve patient prognosis. conditions: Cirrhosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: Death measure: complication sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Chongqing Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400000 country: China name: juan Kang role: CONTACT phone: +8613996112052 email: 68368892@qq.com lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06328504 id: Cashew Protocol briefTitle: Efficacy of Cashew Nut Protein Immunotherapy overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-04-21 date: 2027-04-21 date: 2024-03-25 date: 2024-03-25 name: Medical University of Warsaw class: OTHER briefSummary: It is a randomized, sigle-center, controlled trial to evaluate the effectiveness of oral immunotherapy with cashew protein compared with standard treatment (elimination diet) in pediatric patients with cashew allergy. conditions: Food Allergy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 39 type: ESTIMATED name: Cashew immunotherapy measure: Cashew full tolerance measure: Cashew partial tolerance measure: OIT safety measure: Wheal diamater in skin prick tests measure: SIgE and IgG 4 levels measure: BAT scores measure: Quality of life- FAQLQ measure: Air condensate sex: ALL minimumAge: 4 Years maximumAge: 17 Years stdAges: CHILD facility: Medical University of Warsaw city: Warsaw state: Mazowieckie zip: 02-091 country: Poland name: Agnieszka Szczukocka-Zych, MD role: CONTACT phone: +48 22 3179427 email: agnieszka.szczukocka-zych@wum.edu.pl lat: 52.22977 lon: 21.01178 hasResults: False

 nctId: NCT06328491 id: OZUHN-014 id: 22-5325 type: OTHER domain: University Health Network briefTitle: Erdafitinib in Metastatic Steroid-cell Ovarian Cancer overallStatus: COMPLETED date: 2022-05-30 date: 2022-08-22 date: 2022-08-22 date: 2024-03-25 date: 2024-03-25 name: University Health Network, Toronto class: OTHER briefSummary: This is a single participant study of erdafitinib for the treatment of a patient with metastatic steroid-cell tumor of the ovary. conditions: Ovarian Cancer conditions: Steroid Cell Tumor, Malignant studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1 type: ACTUAL name: Erdafitinib measure: Tumor response measure: Overall health status sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Princess Margaret Cancer Centre city: Toronto state: Ontario zip: M5G 2M9 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06328478 id: Predictors of AKI in PICU. briefTitle: Predictors of Acute Kidney Injury in Critically Ill Children Admitted to PICU. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-01 date: 2025-05-01 date: 2024-03-25 date: 2024-04-16 name: Assiut University class: OTHER briefSummary: Predictors of Acute Kidney Injury in critically ill children admitted to PICU during one year. conditions: Acute Kidney Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Observational prospective study. measure: Incidence of acute kidney injury and survival to discharge from the PICU. sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06328465 id: IEO 1108 briefTitle: fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases acronym: fREEDOM overallStatus: RECRUITING date: 2019-11-22 date: 2028-12-31 date: 2028-12-31 date: 2024-03-25 date: 2024-03-25 name: European Institute of Oncology class: OTHER briefSummary: The aim of this study is to understand whether DWB-MRI (Diffusion Whole Body-Magnetic Resonance Imaging) is useful for early detection of locoregional or distant recurrence and whether early diagnosis influences the prognosis in high-risk populations thanks to the possibility of being able to use a more effective treatment. The primary objective is to evaluate 5-year overall survival (OS) in patients with Human Epidermal Growth Factor Receptor 2 positive (HER2+) or high-risk Triple Negative (TN) undergoing surveillance with DWB-MRI. conditions: Invasive Breast Cancer conditions: HER2-positive Breast Cancer conditions: Triple Negative Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 145 type: ESTIMATED name: Diffusion whole body MRI measure: 5-year overall survival measure: Overall survival of patients underwent local treatment measure: Breast cancer specific survival measure: Safety of local treatment measure: Anxiety assessment measure: Health state assessment measure: Ability to Cope With Trauma assessment measure: Personality assessment measure: Acceptability and perception of DWB-MRI sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan zip: 20141 country: Italy name: Monica Iorfida, MD role: CONTACT phone: +390257489970 email: monica.iorfida@ieo.it name: Mara Negri role: CONTACT phone: +390257489536 email: mara.negri@ieo.it name: Monica Iorfida, MD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06328452 id: MASLD briefTitle: Risk Factors and Impact MASLD in Patients With IBD acronym: MASLD overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-30 date: 2025-06-30 date: 2024-03-25 date: 2024-03-25 name: Assiut University class: OTHER briefSummary: Inflammatory bowel disease (IBD) is a chronic disease characterized by remitting and relapsing inflammation of the gastrointestinal tract. Crohn's disease (CD) and ulcerative colitis (UC) are the two main types of IBD and their incidence and prevalence are increasing.

In about 5-50% of patients with IBD, there are several extraintestinal manifestations as primary sclerosing cholangitis, autoimmune/granulomatous hepatitis, and non-alcoholic fatty liver disease (NAFLD).

Metabolic dysfunction-associated steatotic liver disease "MASLD"(formerly NAFLD) is a spectrum of hepatic diseases associated with metabolic and cardiovascular disorders, such as obesity, insulin resistance (IR), hypertension, dyslipidemia, impaired glucose tolerance and type 2 diabetes mellitus.

The risk factors of developing liver steatosis in patients with IBD remain undetermined. Some studies have supported traditional risk factors, such as type 2 Diabetes mellitus (T2DM), weight gain, or obesity, to contribute to MAFLD development in patients with IBD. Other studies have highlighted the involvement of disease activity, duration, drug-induced liver injury and small bowel surgeries in MAFLD progression.

Limited data are available on the frequency and risk factors of MASLD in Egyptian patients with IBD, and no published Egyptian study has addressed the clinical utility of serum steatosis markers in MASLD prediction in IBD population. Moreover, the impact of MASLD on IBD course is unclear. Therefore, we will conduct our study to shed some light on this issue. conditions: Metabolic Dysfunction-associated Steatotic Liver Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: FibroScan measure: Assess the prevalence and risk factors of metabolic dysfunction associated steatotic liver disease among patients attending inflammatory bowel disease outpatient clinic measure: Effect of metabolic dysfunction associated steatotic liver disease on inflammatory bowel disease course measure: Performance of serum steatosis markers in prediction of steatosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328439 id: ANS014004-I-CN-01 briefTitle: A Study to Evaluate ANS014004 in Subjects With Locally Advanced or Metastatic Solid Tumors overallStatus: RECRUITING date: 2024-03-19 date: 2027-12-31 date: 2028-01-31 date: 2024-03-25 date: 2024-03-25 name: Avistone Biotechnology Co., Ltd. class: INDUSTRY name: Shanghai Chest Hospital name: Hunan Cancer Hospital name: Henan Cancer Hospital name: Zhejiang Cancer Hospital name: Peking University Cancer Hospital & Institute briefSummary: Brief Summary: This is a Phase I, first-in-human, open-label, multi-center study designed to explore the safety, tolerability, PK, and anti-tumor antitumor activity of ANS014004 monotherapy in subjects with locally advanced or metastatic solid tumors.

* The study consists of two parts: a dose-escalation part (Part 1) and a dose-expansion part (Part 2). For each subject, the study will consist of a screening period (Day -28 to Day -1), a treatment period (until discontinuation of treatment) and a follow-up period (including safety follow-up and survival follow-up).
* During the Treatment Period, subjects will receive ANS014004 single-agent oral administration until the subject meets any treatment termination criteria.

  1, The dose-escalation part (Part 1) will consist of a single-dose period and a multiple-dose period (28 days per cycle), participants during dose escalation will receive a single dose of ANS014004 on Day 1 of the single-dose period in order to obtain complete PK parameters for the single dose. There will be a 7-day washout period between the single dosing period and the multiple dosing period at the same dose level. If no dose-limiting toxicity (DLT) occurs during the 7-day washout period, participants will begin Cycle 1 (28 days per cycle) multiple dosing treatment on Day 8, receiving ANS014004 once daily (QD). participants in the backfill cohort will enter the multiple dosing period directly. The specific dose which participant receives will depend on the different cohort assignments. The dose-escalation part (Part 1) will use the initial accelerated titration design (ATD) and the traditional "3 + 3" design to determine the MTD of ANS014004 in subjects with locally advanced or metastatic solid tumors.

  2. In the Dose Expansion (Part 2), participants, will receive oral administration of ANS014004 QD at each treatment cycle (28 days per cycle). An end-of-treatment (EOT) visit will be conducted within 7 days of the final dose or investigator decision to discontinue.

All subjects will undergo imaging evaluations of their tumors every 8 weeks until disease progression is confirmed by the investigator, the subject begins new antitumor therapy, dies, is lost to follow-up, or withdraws from the study, whichever occurs first. conditions: Locally Advanced or Metastatic Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: Cohort1: 7.5mg Cohort2: 15mg Cohort3: 30mg Cohort4: 45mg Cohort5: 60mg primaryPurpose: TREATMENT masking: NONE count: 216 type: ESTIMATED name: ANS014004 measure: Incidence of Adverse Events (AEs) measure: Incidence of Serious Adverse Events (SAEs) measure: Incidence of dose-limiting toxicities (DLT) as defined in the protocol measure: Incidence of baseline laboratory finding, ECG and vital signs changes measure: Proportion of patients with radiological response (ORR) measure: Objective Response Rate (ORR) measure: Duration of Response (DoR) measure: Disease Control Rate (DCR) measure: Progression free Survival (PFS) measure: Overall Survival (OS) measure: Pharmacokinetics of ANS014004: Plasma PK concentrations measure: Pharmacokinetics of ANS014004: Area under the concentration time curve (AUC) measure: Pharmacokinetics of ANS014004: Maximum plasma concentration of the study drug (C-max) measure: Pharmacokinetics of ANS014004: Time to maximum plasma concentration of the study drug (T-max) measure: Pharmacokinetics of ANS014004: Clearance measure: Pharmacokinetics of ANS014004: Half-life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital status: RECRUITING city: Shanghai country: China name: Shun Lu, Ph.D role: CONTACT phone: +8618017321551 email: shunlu_shchest@sina.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06328426 id: Anti-osteoarthritis briefTitle: Vitamin D With Omega-3 or Metformin in Osteoarthritis overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-08 date: 2026-12 date: 2024-03-25 date: 2024-03-25 name: Assiut University class: OTHER briefSummary: To determine the efficacy of vitamin D with omega-3 or metformin for reducing knee symptoms and effusion synovitis in patients with symptomatic knee osteoarthritis. conditions: Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 60 type: ESTIMATED name: Vitamin D name: Omega-3 name: Metformin name: Placebo measure: Effusion-synovitis volume on musculoskeletal ultrasound. sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328413 id: KAEK-302 briefTitle: L-PRF vs PBM on Extraction Socket Healing overallStatus: COMPLETED date: 2020-04-20 date: 2021-06-21 date: 2021-09-21 date: 2024-03-25 date: 2024-03-25 name: Akdeniz University class: OTHER briefSummary: The aim of this study is to compare leukocyte and platelet-rich fibrin (L-PRF) and photobiomodulation (PBM) applications, which have been repeatedly reported to be superior to control groups, in terms of pain, soft tissue and bone healing in tooth extraction sockets. conditions: Healing Surgical Wounds conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Since the groups were formed on the same individual, only which side would be the PBM and which side would be the L-PRF group was determined by coin-flip method (simple randomization). primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 34 type: ACTUAL name: photobiomodulation name: Leukocyte and Platelet Rich Fibrin measure: Newly formed bone (Healing at extraction sockets) measure: Soft tissue healing measure: Probing depth measure: Postoperative pain sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Akdeniz University city: Antalya state: Merkez zip: 07058 country: Turkey lat: 36.90812 lon: 30.69556 hasResults: False

 nctId: NCT06328400 id: VV116-RSV-02 briefTitle: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Deuremidevir Hydrobromide for Suspension overallStatus: RECRUITING date: 2024-03-27 date: 2024-06-30 date: 2024-08-30 date: 2024-03-25 date: 2024-04-24 name: Vigonvita Life Sciences class: INDUSTRY briefSummary: This trial is a multi dose, randomized, double-blind, placebo-controlled, single center Phase I clinical study. The purpose of this study is to evaluate the safety, tolerability, and PK characteristics of Deuteromide Hydrobromide for Suspension administered multiple times in healthy volunteers. conditions: Respiratory Syncytial Virus Infections studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 24 type: ESTIMATED name: Deuremidevir Hydrobromide for Suspension name: Deuremidevir Hydrobromide for Suspension Placebo measure: Incidence of Treatment-Emergent Adverse Events measure: Cmax measure: Tmax measure: AUC0- t measure: AUC0-∞ measure: t1/2 sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Hushan Hospital Fudan university status: RECRUITING city: Shanghai state: Shanghai zip: 201900 country: China name: Xiaojie Wu role: CONTACT phone: 13524686330 email: maomao_xj@163.com name: Jufang Wu role: CONTACT phone: 13816357099 email: 13816357099@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06328387 id: SYSKY-2024-064-03 briefTitle: HCQ+ADC vs ADC in the Treatment of Advanced Breast Cancer overallStatus: RECRUITING date: 2024-01-29 date: 2026-02-01 date: 2026-03-01 date: 2024-03-25 date: 2024-03-25 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: Advanced breast cancer is a special subtype of human breast cancer. Conventional guidelines recommend chemotherapy combined with other adjuvant therapies for this subtype of patients. However, the choice of treatment for these patients after treatment progress is a research hotspot in this field. Trastuzumab Deruxtecan (T-DXd) and Sacituzumab Govitecan (SG) are new ADC drugs targeting HER2 or TROP-2 with high efficacy and low toxicity after the progress of first-line treatment. The autophagy agents hydroxychloroquine or chloroquine has become the only FDA (Food and Drug Administration) approved autophagy inhibitor, and hydroxychloroquine and antibody-drug conjugate(ADC) may have synergistic effects based on the previous work results of our research group.

Therefore,we envisage that Trastuzumab Deruxtecan(T-DXd) or Sacituzumab Govitecan (SG) combined with hydroxychloroquine(HCQ) in the treatment of advanced breast cancer in clinical practice has the advantages of improving efficacy and survival.

To this end, we intend to conduct a prospective,multi-center, phase I/II clinical trial to evaluate the efficacy and safety of T-DXd or SG in combination with HCQ in patients with advacned breast cancer. conditions: Advanced Breast Cancer conditions: Metastatic Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The research model consists of four arms：

1. arm A: SG.
2. arm B: HCQ+SG.
3. arm C: T-DXd .
4. arm D: HCQ+T-DXd. primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Hydroxychloroquine name: Sacituzumab Govitecan name: Trastuzumab Deruxtecan measure: Dose Limiting Toxicity, DLT measure: Adverse event, AE measure: Objective Response Rate, ORR measure: Progression-Free Survival, PFS measure: Overall Survival, OS measure: Clinical Benefit Rate, CBR measure: Disease Control Rate, DCR measure: The rate of adverse events measure: Quality of life scale score, QoL measure: Exploration of biomarkers sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510120 country: China name: Jianli J Zhao, doctorate role: CONTACT phone: 15920589334 email: zhaojli5@mail.sysu.edu.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06328374 id: 240420 briefTitle: Voice and Swallowing Disorders in Adults With and Without Alzheimer's Disease overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-03 date: 2026-12 date: 2024-03-25 date: 2024-03-26 name: Vanderbilt University Medical Center class: OTHER briefSummary: This research study is investigating whether people with Alzheimer's disease experience more changes to voice and swallowing than their healthy age-matched peers. The prevalence of swallowing impairments in moderate-severe Alzheimer's Disease is high (85-93%) and voice is also often negatively impacted by Alzheimer's disease. The overall objective of this study is to evaluate the voice and swallowing function of adults with and without Alzheimer's disease. The investigators will also be involving the primary caregivers of individuals with Alzheimer's that are enrolled in the study to better understand the impact of voice and swallowing impairments on the primary caregivers of those with Alzheimer's Disease.

Healthy adults and individuals with Alzheimer's disease will:

* undergo tests of cough, voice, and swallow function
* undergo tests of grip and tongue strength
* complete questionnaires

Caregivers of individuals with Alzheimer's disease will also complete questionnaires. conditions: Alzheimer Disease conditions: Caregiver Burden conditions: Healthy Aging conditions: Dysphonia conditions: Dysphagia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: Swallowing safety measure: Voluntary cough peak expiratory flow measure: Vocal fold bowing index measure: Swallowing and Eating Related Fatigue Questionnaire (SERF) measure: Swallowing Related Quality of Life Questionnaire (SWAL-QOL) measure: Voice Handicap Index (VHI) measure: Aging Voice Index (AVI) measure: Grip Strength measure: Tongue strength measure: Clinical frailty scale measure: Caregiver Analysis of Reported Experiences with Swallowing Disorders (CARES) Questionnaire measure: Caregiver Self-Assessment Questionnaire sex: ALL minimumAge: 60 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328361 id: R24008 briefTitle: Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer acronym: NORPPA-1 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-12-31 date: 2032-12-31 date: 2024-03-25 date: 2024-03-25 name: Tampere University Hospital class: OTHER name: Tampere University name: Helsinki University Central Hospital name: Turku University Hospital name: Kuopio University Hospital name: Oulu University Hospital name: Jyväskylä Central Hospital name: Seinajoki Central Hospital name: Satakunta Central Hospital name: North Karelia Central Hospital name: Tartu University Hospital name: East Tallinn Central Hospital name: West Tallinn Central Hospital name: North Estonia Medical Centre briefSummary: The goal of this one-arm clinical trial is to implement and study the oncological outcomes of nonoperative management of rectal cancer having complete clinical response to neoadjuvant therapy. The main questions to answer are

* if the oncological results of nonoperative management after Nordic practice in chemoradiotherapy indications differ from experiences elsewhere
* what is the organ preservation rate
* what is the local regrowth rate conditions: Rectal Cancer conditions: Rectal Adenocarcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Nonoperative surveillance measure: Disease-free survival measure: Overall survival measure: TME-free survival measure: ctDNA-free survival measure: Post local regrowth disease-free survival measure: Post local regrowth overall survival measure: Local regrowth-free survival measure: Local recurrence-free survival measure: Distant metastases-free survival measure: Disease-free survival measure: Salvage rate after local regrowth measure: Quality of life score measure: Complication rates sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: East Tallinn Central Hospital city: Tallinn country: Estonia lat: 59.43696 lon: 24.75353 facility: North Estonia Medical Centre city: Tallin country: Estonia name: Indrek Seire, MD, PhD role: CONTACT email: indrek.seire@ut.ee lat: 59.43696 lon: 24.75353 facility: West Tallinn Central Hospital city: Tallin country: Estonia name: Kaur Liivak, MD, PhD role: CONTACT email: kaur.liivak@keskhaigla.ee lat: 59.43696 lon: 24.75353 facility: Tartu University Hospital city: Tartu country: Estonia name: Jaan Soplepman, MD, PhD role: CONTACT email: jaan.soplepmann@kliinikum.ee lat: 58.38062 lon: 26.72509 facility: Helsinki University Central Hospital city: Helsinki zip: 00290 country: Finland name: Anna H Lepistö, MD, PhD role: CONTACT email: anna.lepisto@hus.fi lat: 60.16952 lon: 24.93545 facility: North Karelia Central Hospital city: Joensuu country: Finland name: Markku Matikainen, MD, PhD role: CONTACT email: markku.matikainen@siunsote.fi, lat: 62.60118 lon: 29.76316 facility: Jyväskylä Central Hospital city: Jyväskylä country: Finland name: Kyösti Tahkola, MD, PhD role: CONTACT email: kyosti.tahkola@hyvaks.fi lat: 62.24147 lon: 25.72088 facility: Kuopio University Hospital city: Kuopio country: Finland name: Anne Fageström, MD, PhD role: CONTACT email: anne.fagerstrom@pshyvinvointialue.fi lat: 62.89238 lon: 27.67703 facility: Oulu University Hospital city: Oulu country: Finland name: Karoliina Paarmio, MD, PhD role: CONTACT email: karoliina.paarnio@pohde.fi lat: 65.01236 lon: 25.46816 facility: Satakunta Central Hospital city: Pori country: Finland name: Jyrki Haikonen, MD, PhD role: CONTACT email: jyrki.haikonen@sata.fi lat: 61.48333 lon: 21.78333 facility: Seinajoki Central Hospital city: Seinäjoki country: Finland lat: 62.79446 lon: 22.82822 facility: Tampere University Hospital city: Tampere zip: 33400 country: Finland name: Toni T Seppälä, MD, PhD role: CONTACT phone: +358444722846 email: toni.seppala@tuni.fi lat: 61.49911 lon: 23.78712 facility: Turku University Hospital city: Turku country: Finland name: Pirita Varpe, MD, PhD role: CONTACT email: Pirita.Varpe@tyks.fi lat: 60.45148 lon: 22.26869 hasResults: False

 nctId: NCT06328348 id: SW010 briefTitle: Assessing the Synergistic Effects of Black Cohosh, Soy Isoflavones, and SDG Lignans (Soloways TM) on Menopausal Symptoms overallStatus: COMPLETED date: 2023-07-18 date: 2023-11-30 date: 2023-12-30 date: 2024-03-25 date: 2024-03-25 name: S.LAB (SOLOWAYS) class: OTHER name: Center of New Medical Technologies briefSummary: This clinical trial aimed to evaluate the effectiveness of a combination of Black Cohosh, Soy Isoflavones, and SDG Lignans compared to a placebo in reducing menopausal symptoms in postmenopausal women aged 45-60 years. The study was meticulously designed to be a randomized, double-blind, parallel-group trial, ensuring rigorous scientific standards and participant confidentiality. It received ethical approval and adhered to the Declaration of Helsinki guidelines. Participants were carefully selected based on specific inclusion and exclusion criteria to maintain the study's integrity and relevance to the target population.

The trial involved 96 eligible women from the Center for New Medical Technologies registry in Novosibirsk, Russia, divided into two groups through a computer-generated random sequence. One group received the active supplements, while the other received a placebo, with both groups and researchers blinded to the assignments. The supplements and placebos were produced to be indistinguishable in appearance, with dosages designed to maximize absorption and efficacy while minimizing side effects. The primary endpoint was the change in Menopause Rating Scale (MRS) scores, with secondary outcomes focusing on adverse symptoms and key hormonal changes.

The study's design also included measures to ensure adherence and minimize bias, such as drug container returns and daily reminders. The involvement of S.Lab (Soloways) was limited to manufacturing the supplements, with the research conducted independently to avoid commercial influence. The sample size calculation indicated that 48 participants per group would provide adequate power to detect significant differences in menopausal symptom reduction, aiming for a high level of confidence and statistical power. conditions: Menopause Symptoms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 96 type: ACTUAL name: supplementation name: placebo measure: Change in the Menopause Rating Scale (MRS) score measure: Follicle-Stimulating Hormone (FSH) change measure: Estradiol change measure: Number of any adverse events sex: FEMALE minimumAge: 45 Years maximumAge: 60 Years stdAges: ADULT facility: Center of New Medical Technologies city: Novosibirsk state: Novosibisk Region zip: 630090 country: Russian Federation lat: 55.0415 lon: 82.9346 hasResults: False

 nctId: NCT06328335 id: Orthostatic Hypotension briefTitle: The Effect of Rehabilitation Training on Orthostatic Hypotension in Parkinson's Patients overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore raise-bed training Orthostatic Hypotension in Parkinson's Patients. The main question it aims to answer is:

Can raise-bed training improve Orthostatic Hypotension in Parkinson's Patients. Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given raise-bed training. The study lasts 21 days for each patient. Researchers will compare Orthostatic Hypotension Questionnaire, Orthostatic Grading Scale, Composite Autonomic Symptom Scale 31 to see if raise-bed training can help improve the symptom conditions: Orthostatic Hypotension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Comprehensive rehabilitation training name: Rise-bed Training measure: Composite Autonomic Symptom Scale 31 measure: Orthostatic Hypotension Questionnaire measure: Orthostatic Grading Scale sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328322 id: Soh-Med-24-03-02MD briefTitle: Study of Percutaneous Coronary Intervention in Left Main Coronary Artery Disease in Patients With Acute Coronary Syndrome at Sohag University Hospitals overallStatus: RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-03-25 date: 2024-03-25 name: Sohag University class: OTHER briefSummary: Acute coronary syndromes (ACS) encompass a spectrum of cardiovascular disorders characterized by the sudden onset of myocardial ischemia. They are primarily caused by atherosclerotic plaque rupture or erosion, leading to partial or complete occlusion of the coronary arteries. Among the various coronary arteries affected, left main coronary artery disease (LMCAD) is of particular concern due to its high anatomical significance and potential for adverse outcomes

The left main coronary artery (LMCA) is responsible for supplying a substantial portion of the left ventricular myocardium, including the interventricular septum and the anterior and lateral walls. Any obstruction or compromise in blood flow within this critical artery can have severe consequences, including myocardial infarction, heart failure, or even sudden cardiac death. The management of LMCAD associated with ACS represents a significant clinical challenge, necessitating prompt and optimal treatment strategies

Among the various coronary arteries affected by atherosclerosis, left main coronary artery disease (LMCAD) holds particular clinical significance due to its anatomical location and the vital role it plays in supplying a substantial portion of the left ventricular myocardium. The left main coronary artery (LMCA) typically bifurcates into the left anterior descending artery (LAD) and the left circumflex artery (LCX), which together provide blood supply to the majority of the left ventricle, including the interventricular septum and the anterior and lateral walls

The selection of an appropriate treatment strategy for LMCAD associated with ACS is a complex decision that requires careful consideration of multiple factors, including patient characteristics, coronary anatomy, severity of ischemia, and procedural expertise. The emergence of several clinical trials and observational studies exploring the efficacy and safety of different revascularization strategies has further complicated the decision-making process conditions: Left Main Coronary Artery Disease With Acute Coronary Syndrome studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Percutaneous Coronary Intervention in Left Main Artery Disease measure: major adverse cardiac events (MACE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag university Hospital status: RECRUITING city: Sohag country: Egypt name: Magdy M Amin, professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06328309 id: Myofascial Traumatic Brain briefTitle: Impact of v Release on Dysphagia in Patients With Traumatic Brain Injury overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Traumatic Brain injured Survivors. The main question it aims to answer is:

• Can Myofascial Release Therapy improve swallowing function in Traumatic Brain injured Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation treatment name: Myofascial Release Therapy measure: Penetration-Aspiration Scale measure: Swallowing Quality of Life questionnaire measure: Patient health questionnaire-9 measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328296 id: Myofascial Parkinson's Dysphag briefTitle: Impact of Myofascial Release on Dysphagia in Parkinson's Disease Patients overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Parkinson's Patients. The main question it aims to answer is:

• Can Myofascial Release Therapy improve swallowing function in Parkinson's Patients? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation treatment name: Myofascial Release Therapy measure: Penetration-Aspiration Scale measure: Swallowing Quality of Life questionnaire measure: patient health questionnaire-9 measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328283 id: Soh-Med-24-02-01MD briefTitle: The Diagnostic Efficacy of Glutamine Synthetaseand BCLAF1in Early Diagosis of Hepatocellular Carcinoma in Cirrhotic Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-01 date: 2026-03-01 date: 2024-03-25 date: 2024-03-25 name: Sohag University class: OTHER briefSummary: Hepatocellular carcinoma (HCC) is the most prominent kind of liver cancer, accounting for 85% of primary liver malignancies. It is a very aggressive tumor, having a terrible prognosis and poor survival rate HCC is ranked as the sixth most common type of cancer and the third leading cause of cancer-related mortalities world wide.

HCC incidences arise in complications associated with chronic liver disease like cirrhosis, endemic hepatitis B virus (HBV)/hepatitis C virus (HCV) infections, non alcoholic fatty liver disease (NAFLD), and alcohol-related liver disease (Torre, 2015). conditions: Hepatocellular Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 90 type: ESTIMATED name: measure of Glutamine synthetase and BCLFAF1 measure: glutamine synthetase sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag university Hospital city: Sohag state: Sohagm country: Egypt name: Magdy M Amin, professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06328270 id: 03.09.2019 / 2505 briefTitle: Comparison of the Therapeutic Effects of Intra-Articular Injection of Ozone and Corticosteroid in Knee Osteoarthritis overallStatus: COMPLETED date: 2020-09-01 date: 2022-01-30 date: 2022-03-30 date: 2024-03-25 date: 2024-03-25 name: Sisli Hamidiye Etfal Training and Research Hospital class: OTHER briefSummary: This clinical trial aimed to involve patients aged 40-85 years who had been experiencing knee pain for at least 6 months and had received a clinical diagnosis of knee osteoarthritis through radiologic imaging. The patients were randomly assigned to two groups. One group received a 3-week intra-articular injection of 15 mg/ml ozone, while the second group received a 1 ml intra-articular injection of betamethasone. All patients were evaluated before treatment, as well as 4 and 12 weeks after the first dose of treatment. The study evaluated treatment efficacy using the Visual Pain Score (VAS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC). conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Ozone - oxygen Therapy name: Corticosteroid measure: Visual Pain Score measure: Western Ontario and McMaster Universities Arthritis Index measure: Visual Pain Score measure: Western Ontario and McMaster Universities Arthritis Index sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06328257 id: Elderly Community Myofascial briefTitle: Impact of Myofascial Release on Preventing Dysphagia in the Elderly Community overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-08 date: 2024-08 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore the impact of Myofascial Release Training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address the effects of Myofascial Release Training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) Myofascial Release Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 300 type: ESTIMATED name: Myofascial Release Training measure: Swallowing-Related Quality of Life Questionnaire measure: Time consumed in eating measure: Functional Oral Intake Scale sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328244 id: Community-Based Swallowing briefTitle: Community-Based Swallowing Training for Elderly Individuals: Impact and Benefits overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-06 date: 2024-03-25 date: 2024-04-11 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 280 type: ESTIMATED name: Simple swallowing training measure: Eating Assessment Tool-10 measure: Time consumed in eating measure: Swallowing-Related Quality of Life Questionnaire sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328231 id: Community elderly dysphagia briefTitle: The Impact of Swallowing Intervention for Elderly Community Dwellers overallStatus: COMPLETED date: 2024-03-25 date: 2024-04-14 date: 2024-04-14 date: 2024-03-25 date: 2024-04-16 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are divided into 2 groups. The intervention group is required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-20 minutes each. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 248 type: ACTUAL name: Systematic simple swallowing training measure: Gugging Swallowing Screen measure: Time consumed in eating measure: Swallowing-Related Quality of Life Questionnaire measure: Eating Assessment Tool-10 sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Railway Commu. city: Zhenzhou country: China lat: 32.28034 lon: 119.16999 hasResults: False

 nctId: NCT06328218 id: Gymnastics ParkinsonCommunity briefTitle: The Effect of Simple Gymnastics Training for Parkinson's Patients in the Community overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-05 date: 2024-05 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore the impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Simple Gymnastics Training measure: Unified Parkinson's Disease Rating Scale measure: The Berg Balance Scale measure: Patient Health Questionnaire-9 sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328205 id: Glossopharyngeal Nerve Block briefTitle: Impact of Glossopharyngeal Nerve Block on Swallowing Difficulties Caused by Gastroesophageal Reflux Disease overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore Clinical Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease. The main question it aims to answer is:

• Can Glossopharyngeal Nerve Block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Glossopharyngeal Nerve Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Rosenbek penetration-aspiration scale, Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, to see if the Glossopharyngeal Nerve Block can help improve the symptom. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation therapy name: Glossopharyngeal Nerve Block name: Lidocaine Hydrochloride name: placebo injection measure: penetration-aspiration scale measure: Gastroesophageal Reflux Disease Questionnaire measure: Pressure pain threshold sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328192 id: active breathing elderly briefTitle: The Impact of Practicing Active Breathing Exercises on Elderly Individuals Living in the Community overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-05 date: 2024-03-25 date: 2024-03-25 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore the impact of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants enrolled are required to undergo a continuous three-week (21 days) Active Breathing Exercises, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 300 type: ESTIMATED name: Active Breathing Exercises measure: Standardized Swallowing Assessment Scale measure: Time consumed in eating measure: Swallowing-Related Quality of Life Questionnaire sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328179 id: KY-2023-058-01 briefTitle: Clinical Study Protocol for the Treatment of ND-AML and RR-AML With KMT2A Gene Abnormalities Using VHEA. overallStatus: RECRUITING date: 2022-05-24 date: 2027-12-30 date: 2027-12-30 date: 2024-03-25 date: 2024-03-25 name: Huai'an First People's Hospital class: OTHER name: Zhenjiang First People's Hospital name: The First People's Hospital of Changzhou name: The Affiliated Hospital of Xuzhou Medical University briefSummary: This study is a clinical trial aimed at evaluating the efficacy and safety of the VHEA（Venetoclax with Homoharringtonine，Etoposide，Cytarabine）regimen in the treatment of newly diagnosed and relapsed/refractory acute myeloid leukemia (AML) with MLL gene abnormalities.

This study includes the induction and consolidation phases of AML treatment. conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 34 type: ESTIMATED name: Venetoclax 100 mg d1，200 mg d2，400 mg d3-14； measure: Overall response rate，ORR measure: Overall survival, OS measure: Event free survival, EFS measure: Duration of remission, DOR measure: Adverse event, AE measure: Treatment-related mortality, TRM sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University（Huai'an First People's Hospital） status: RECRUITING city: Huai'an state: Jiangsu zip: 210000 country: China name: Shandong Tao role: CONTACT phone: 15252393900 email: TSD8884@126.com lat: 33.50389 lon: 119.14417 hasResults: False

 nctId: NCT06328166 id: rFGF-1 for CTS briefTitle: The Effect and Safety of Recombinant Fibroblast Growth Factor-1 for Carpal Tunnel Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-03-22 date: 2024-12-31 date: 2024-12-31 date: 2024-03-25 date: 2024-03-25 name: Tri-Service General Hospital class: OTHER name: Eusol Biotech Co., Ltd. briefSummary: Carpal tunnel syndrome (CTS) is a common peripheral entrapment mononeuropathy of the upper limb, which results from compression of median nerve at level of wrist. In recent years, regenerative medicine has gradually been applied in the treatment of various degenerative conditions such as bones, muscles, and nerves. Human fibroblast growth factor 1 is a single-chain protein , which has been shown to play a crucial regulatory role in the brain and spinal cord and can facilitate nerve cell differentiation and growth. ES135 is a recombinant human fibroblast growth factor 1 (rhFGF1) which is composed of 135 amino acids with a molecular weight of approximately 15.2 kilodalton. Several studies have shown that significant improvement of Functional Independence Measure, motor and sensory function of spinal cord injury patients after ES135 treatment. One study also revealed the muscle strength have significant improvement in brachial plexus injury patients after ES135 therapy. According to above studies, the investigators hypothesized that ES135 may have benefits to CTS patients. Hence, the purpose of this study aim to demonstrate the therapeutic effects and safety of ES135 for CTS. conditions: Carpal Tunnel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 28 type: ESTIMATED name: Sono-guided injection with ES135 name: Sono-guided injection with placebo measure: Change from baseline of severity of symptoms and functional status on 1st month, 2nd month, 3rd month,4th month, 6th month after injection. measure: Change from baseline of pain on 1st month, 2nd month, 3rd month,4th month, 6th month after injection. measure: Change from baseline of cross-sectional area of the median nerve on 1st month, 2nd month, 3rd month,4th month, 6th month after injection. measure: Change from baseline of conduction velocity, latency of median nerve on 1st month, 2nd month, 3rd month,4th month, 6th month. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328153 id: BF2022-101 briefTitle: Efficacy and Mechanism of FSN Treatment for Senile Knee Osteoarthritis overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-01-01 date: 2026-03-01 date: 2024-03-25 date: 2024-03-25 name: Guangdong Provincial Hospital of Traditional Chinese Medicine class: OTHER briefSummary: The goal of this clinical trial is to compare FSN with oral Nonsteroidal Antiinflammatory Drugs (NSAIDs) in pain relief and improvement in knee function among elder people, the main questions it aims to answer are:

Q1: Compared with the positive drug (celecoxib), whether FSN is more or at least as effective for pain relief and improvement in knee function in elder people with knee arthritis.

Q2: From the biomechanical point of view, what is the mechanism by which FSN plays a therapeutic role in knee osteoarthritis (KOA)?

Participants will:

1. Will be randomly assigned to 2 groups. There will be 30 participants in each group.
2. A group of patients will receive FSN monotherapy, while the other group will receive oral celecoxib and pantoprazole. Each patient will receive a 2-week course of treatment.
3. Visual analogue scale (VAS), WOMAC, knee range of motion (ROM), gait analysis, and musculoskeletal ultrasonography (US) of lower extremity muscles will be assessed during treatment and in the follow-up.

Researchers will compare FSN and celecoxib to see if FSN has better, or at least equivalent, efficacy than celecoxib, which is commonly used in clinical practice. conditions: Osteoarthritis, Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Fu's Subcutaneous Needling name: Celecoxib measure: Change from Baseline in the visual analogue scale (VAS) (0-100 mm) at the 14th day after receiving treatment. measure: Change from Baseline in the visual analogue scale (VAS) (0-100 mm) at the 7th day, the 28th day and 42th day after the start of treatment. measure: Change from Baseline in The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at the 7th day, the 14th day, the 28th day and 42th day after the start of treatment. measure: Change from Baseline in the active range of motion (ROM) of the knee at the 7th day,the 14th day,the 28th day and 42th day after the start of treatment. measure: Change from Baseline in the data of the Three-dimensional gait analysis at the 7th day and 14th day after the start of treatment. measure: Change from Baseline in the data of the shear wave elastic imaging technology analysis at the 7th day and 14th day after the start of treatment. measure: Incidence of Treatment-Emergent Adverse Events sex: ALL minimumAge: 60 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328140 id: Skyland 001 briefTitle: Sleep Quality, Cognitive Performance, and Computerized Cognitive Training overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-04-14 date: 2026-04-14 date: 2024-03-25 date: 2024-03-25 name: George West Mental Health Foundation d/b/a Skyland Trail class: OTHER name: Sumitomo Pharmaceuticals America briefSummary: Poor sleep quality is common in neuropsychiatric conditions and some of the problems associated with poor sleep at night may be due to medication side effects or reduced efficacy of certain treatments. Poor sleep quality has been implicated in cognitive impairments, with the sleep quality to cognition association so strong that specialized assessments have been developed to examine the subjective association between poor nighttime sleep and daytime cognitive impairment.

Computerized cognitive training (CCT) is a training procedure designed to build cognitive skills, with a goal of improvement of functional outcomes. CCT is also a learning-based approach and previous studies have shown that successful CCT interventions lead to changes in brain circuitry. It is also known, however, that many cases who are treated with CCT fail to make treatment-related gains. Recent studies have suggested that this may be associated with failures to engage in the training procedures, which could be related to sleep related impairments.

Increased anticholinergic load can also substantially disrupt the process of training related gains directly. Antihistaminergic effects, common to many antidepressant and antipsychotic medications, can lead to daytime sedation and sleepiness, which both interferes with treatment but also interferes with nighttime sleep as well

In previous clinical trials, Lurasidone was associated with reductions in sleepiness and with cognitive gains that exceeded practice effects. One viable hypothesis is that Lurasidone has both direct beneficial effects on cognition and substantial indirect benefits, due to the lack of histamine receptor occupancy, lack of anticholinergic effects, and direct promotion of positive nighttime sleep outcomes.

Thus, a broad-spectrum naturalistic comparison of Lurasidone-treated patients with patients treated with other medications is proposed. This would include examining the level of engagement in CCT treatment, measurement of CCT training gains, and relating engagement and training gains with concurrent sleep quality, measured by actigraphy. conditions: Bipolar Disorder conditions: Major Depressive Disorder conditions: Psychosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Lurasidone name: FDA Approved antidepressant treatment measure: Improvement in Cognitive Performance measure: Training Engagement in Cognitive training measure: Nighttime sleep measured with actigraphy sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: George West Mental Health Foundation, DBA Skyland Trail city: Atlanta state: Georgia zip: 30329 country: United States name: Ben W Hunter, MD role: CONTACT phone: 866-504-4966 email: bhunter@skylandtrail.org name: Ben W Hunter, MD role: PRINCIPAL_INVESTIGATOR name: Alex O Rothbaum, PhD, MPH role: SUB_INVESTIGATOR name: Philip D Harvey, PhD role: SUB_INVESTIGATOR lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06328127 id: 23-691 briefTitle: Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors acronym: PATH-4 overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-30 date: 2029-04-30 date: 2024-03-25 date: 2024-03-25 name: Brigham and Women's Hospital class: OTHER name: Dana-Farber Cancer Institute name: Duke University name: H. Lee Moffitt Cancer Center and Research Institute briefSummary: This randomized clinical trial is evaluating the impact of a positive psychology intervention (PATH) on anxiety symptoms, depression symptoms, and quality of life in survivors of hematopoietic stem cell transplant (HSCT) compared to usual care. conditions: Hematopoietic Stem Cell Transplant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 400 type: ESTIMATED name: PATH measure: Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale measure: Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale measure: Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale measure: Gratitude based on the Gratitude Questionnaire measure: Positive Affect based on the Positive and Negative Affect Schedule Positive Affect Subscale measure: Physical function based on the Patient-Reported Outcomes Measurement Information System-Physical Function-20 measure: Patient-Reported Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) measure: Flourishing based on the Flourishing Scale measure: Optimism based on the Life Orientation Test-Revised (LOT-R) measure: Coping based on the Brief-COPE questionnaire measure: Post-traumatic stress based on the Post-traumatic Stress Checklist-Civilian Version measure: Steps per day based on the ActiGraph accelerometer measure: Sedentary leisure time based on the ActiGraph accelerometer sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Moffitt Cancer Center city: Tampa state: Florida zip: 33612 country: United States name: Heather Jim, PhD role: CONTACT email: heather.jim@moffitt.org lat: 27.94752 lon: -82.45843 facility: Dana Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States lat: 42.35843 lon: -71.05977 facility: Duke Cancer Institute city: Durham state: North Carolina zip: 27710 country: United States name: Thomas LeBlanc, MD role: CONTACT email: thomas.leblanc@duke.edu lat: 35.99403 lon: -78.89862 hasResults: False

 nctId: NCT06328114 id: Pro00114549 briefTitle: Accelerating TMS for Cervical Dystonia overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2029-07-01 date: 2029-07-01 date: 2024-03-25 date: 2024-04-26 name: Duke University class: OTHER name: American Academy of Neurology briefSummary: This study aims to investigate the impact of accelerated transcranial magnetic stimulation (TMS) on brain function and behavior in patients with focal cervical dystonia. Previous research demonstrated that individualized TMS improved writing behavior in focal hand dystonia after one session. In this study, we aim to expand the application on TMS on focal cervical dystonia. The current study administers four TMS sessions in a day. The research involves 9 in-person visits. The effect of TMS will be assessed using functional MRI brain scans and behavioral measurements. The risk of TMS includes seizures; the potential risk of seizures from TMS is mitigated through careful screening, adhering to safety guidelines. The study's main benefit is enhancing dystonic behavior and deepening the understanding of brain changes caused by TMS in cervical dystonia, paving the way for further advancements in clinical therapy for this condition. conditions: Isolated Cervical Dystonia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Single-arm crossover study design with subjects receiving TMS at two different intensities primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The TMS intensity delivered at each TMS visit will be masked whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Transcranial Magnetic Stimulation (TMS) measure: Change in Neck Angles as Measured by Neck Sensor Device measure: Changes in Brain Activity (bold activity) on Functional Magnetic Resonance Imaging (fMRI) measure: Changes in Brain Activity (functional connectivity) on Functional Magnetic Resonance Imaging (fMRI) measure: Behavioral Response After Deep Brain Stimulation (DBS), as measured by Neck Angles sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duke University Health System city: Durham state: North Carolina zip: 27705 country: United States name: Noreen Bukhari-Parlakturk, MD PhD role: CONTACT phone: 919-668-8248 email: movdisres@duke.edu lat: 35.99403 lon: -78.89862 hasResults: False

 nctId: NCT06328101 id: 2023-02558 briefTitle: Autoimmune Pancreatitis, Pancreatic and Extrapancreatic cAnceR (AiPPEAR) acronym: AiPPEAR overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-09-01 date: 2025-04-01 date: 2024-03-25 date: 2024-03-25 name: University Medical Center Goettingen class: OTHER name: University Medical Centre Maribor name: Aalborg University Hospital name: University Hospital Munich name: Tartu University Hospital name: University Hospital in Halle briefSummary: The goal of this observational, retrospective study is to learn about cancer risk in autoimmune pancreatitis (AIP) patients. The main questions it aims to answer are:

* Do patients with AIP have higher incidence of cancer in comparison to general population?
* What is the overall prevalence of cancer in AIP patients?
* What are the characteristics of AIP patients associated with the incidence of cancer? conditions: Autoimmune Pancreatitis Type 1 conditions: Autoimmune Pancreatitis Type 2 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED measure: Standardized incidence ratio (SIR) of first invasive cancer measure: The prevalence of cancer diagnoses 12 months prior to AIP diagnosis measure: Risk factor associated with cancer diagnosis. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328088 id: EC/12/23/2400 briefTitle: Vegetarian Versus Non Vegetarian Based Diet in the Recurrence of Hepatic Encephalopathy in Patients With Cirrhosis: An Open Label Pilot Study overallStatus: RECRUITING date: 2024-02-16 date: 2024-04-16 date: 2024-10-16 date: 2024-03-25 date: 2024-03-25 name: Sir Ganga Ram Hospital class: OTHER briefSummary: Earlier protein restriction was advocated in the treatment of HE but later this concept was refuted and increase protein intake was advocated in patients with HE. Diet in patients during an episode HE is also not known. It is advisable based on many case reports or case series that vegetable-based diet during the episode of HE is better than animal-based diet as it reduces ammonia level and other false neurotransmitters in brain and helps in early recovery of, HE . However, diet in patients who had recovered from an episode of, HE is not known and what type of protein (vegetarian or non-vegetarian) should be taken to prevent another episode of HE has never been evaluated. In India majority of the patients are vegetarian and patients with cirrhosis are malnourished and lack protein in their diet as per our previous published study conditions: Hepatic Encephalopathy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Non vegetarian measure: Recurrence of overt hepatic encephalopathy measure: Hospitalization due to any cause sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sir Ganga Ram Hospital status: RECRUITING city: Delhi zip: 110060 country: India name: Praveen Sharma, MD,DM role: CONTACT phone: 9810365151 lat: 28.65195 lon: 77.23149 hasResults: False

 nctId: NCT06328075 id: AI-ATTR-ECHO id: 20211029191554 type: OTHER domain: registre général des traitements de l'APHP briefTitle: Artificial Intelligence to Assist the Echocardiographic Identification of Transthyretin Cardiac Amyloidosis acronym: AI-ATTR-ECHO overallStatus: RECRUITING date: 2022-01-01 date: 2025-01-01 date: 2026-01-01 date: 2024-03-25 date: 2024-03-25 name: Algalarrondo Vincent class: OTHER name: Bichat Hospital name: Bioquantis briefSummary: The goal of this study is to develop an algorithm using artificial intelligence (AI) to assist identification of potential ATTR-CM cases using routine transthoracic echocardiography.

The main questions it aims to answer are:

* is the algorithm able to diagnose ATTR-CM
* is the algorithm able to diagnose different types of ATTR-CM (ATTRv, ATTRwt)

This is a non interventional study. Participant' echocardiographies will be, after deidentification, used to train, valid and test the algorithm. conditions: Amyloid Cardiomyopathy conditions: Transthyretin Amyloid Cardiomyopathy conditions: Transthyretin Cardiac Amyloidosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 15000 type: ESTIMATED name: non interventional study measure: Building and validating the diagnostic performance metrics curves of the AI algorithm to diagnose ATTR-CM : measure: Building and validating the diagnostic performance metrics of the AI algorithm to diagnose ATTR-CM : measure: Building and validating the diagnostic performance metrics of the AI algorithm to diagnose ATTRwt-CM : measure: Building and validating the diagnostic performance metrics of the AI algorithm to diagnose ATTRv-V122I-CM : measure: Building and validating the diagnostic performance metrics of the AI algorithm to diagnose ATTRv-CM : measure: Building and validating the diagnostic performance metrics of the AI algorithm to differentiate ATTR-CM from LV hypertrophy (LVH) : measure: Building and validating the diagnostic performance metrics curves of the AI algorithm to diagnose ATTRwt-CM : measure: Building and validating the diagnostic performance metrics curves of the AI algorithm to diagnose ATTRv-V122I-CM : measure: Building and validating the diagnostic performance metrics curves of the AI algorithm to diagnose ATTRv-CM : measure: Building and validating the diagnostic performance metrics curves of the AI algorithm to differentiate ATTR-CM from LV hypertrophy (LVH) : sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bichat status: RECRUITING city: Paris zip: 75018 country: France name: Vincent Algalarrondo, MD, PhD role: CONTACT phone: +33140257785 email: vincent.algalarrondo@aphp.fr name: Gregory Ducrocq, PD, PhD role: CONTACT email: gregory.ducrocq@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06328062 id: TUH Mirogabalin TKA briefTitle: Comparing Efficiency of Mirogabalin and Pregabalin in Primary TKA overallStatus: RECRUITING date: 2024-04-01 date: 2025-05-31 date: 2025-05-31 date: 2024-03-25 date: 2024-03-25 name: Thammasat University Hospital class: OTHER briefSummary: The goal of this RCT is to compare efficacy between mirogabalin and pregabalin in pain reducing after unilateral primary total knee arthroplasty.

The main question\[s\] it aims to answer are:

• Does mirogabalin have better pain reduction than pregabalin after unilateral primary total knee arthroplasty.

Participants will randomized to mirogabalin or pregabalin group and will take the drug for 6 weeks after TKA. Researchers will compare to pregabalin group to see pain and functional outcomes after TKA. conditions: Pain Postoperative conditions: Osteoarthritis conditions: Total Knee Arthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Mirogabalin name: Pregabalin measure: Pain score measure: Morphine consumption measure: Range of motion measure: Knee society score measure: Knee injury and Osteoarthritis Outcome Score (KOOS) measure: Sedation score measure: Incidence of Somnolence and dizziness measure: Total hospital stay sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thammasat University Hospital status: RECRUITING city: Khlong Luang state: Pathum Thani zip: 12120 country: Thailand name: Yot Tanariyakul, M.D. role: CONTACT phone: 6683930257 email: y.tanariyakul@gmail.com name: Yot Tanariyakul, M.D. role: PRINCIPAL_INVESTIGATOR name: Krit Boontanapibul, M.D. role: PRINCIPAL_INVESTIGATOR lat: 14.06467 lon: 100.64578 hasResults: False

 nctId: NCT06328049 id: HSKY-033 briefTitle: A Study of Trilaciclib Combined With Chemotherapy in the Treatment of NSCLC overallStatus: RECRUITING date: 2023-08-10 date: 2025-02-10 date: 2025-08-10 date: 2024-03-25 date: 2024-03-25 name: Taixing People's Hospital class: OTHER briefSummary: The aim of this study is to investigate the safety and efficacy of the prophylactic use of Trilaciclib in patients with non-small cell lung cancer (NSCLC) receiving platinum-based chemotherapy, so as to provide more evidence-based medical evidence for the optimal diagnosis and treatment strategy in this population. conditions: NSCLC studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 30 type: ESTIMATED name: Trilaciclib Injection measure: Incidence of febrile neutropenia (FN) measure: Incidence of Treatment-Emergent Adverse Events measure: Antibiotic Use rate measure: Number of medication delays measure: Number of chemotherapy dose reductions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taixing People's Hospital status: RECRUITING city: Taixing state: Jiangsu zip: 225400 country: China name: liu C yang, M.D. role: CONTACT phone: 87656001 phoneExt: 0523 email: liuyctx@163.com lat: 32.16667 lon: 120.01361 hasResults: False

 nctId: NCT06328036 id: NCI-2024-02185 id: NCI-2024-02185 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 10640 type: OTHER domain: University of Pittsburgh Cancer Institute LAO id: 10640 type: OTHER domain: CTEP id: UM1CA186690 type: NIH link: https://reporter.nih.gov/quickSearch/UM1CA186690 briefTitle: Testing the Combination of Anti-cancer Drugs Tiragolumab and Atezolizumab to Improve Outcomes for Patients With Recurrent Glioblastoma overallStatus: NOT_YET_RECRUITING date: 2024-06-21 date: 2025-07-01 date: 2025-07-01 date: 2024-03-25 date: 2024-03-25 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II trial compares the safety, side effects and effectiveness of atezolizumab with tiragolumab to atezolizumab alone in treating patients with glioblastoma that has come back after a period of improvement (recurrent). Glioblastoma is the most common primary brain cancer in adults and despite aggressive treatment, it is nearly always fatal. Currently, there are limited effective treatment options in patients that have recurrence. Immunotherapy has been shown to be effective in other types of cancer and may be an appealing potential treatment option for recurrent glioblastoma. Immunotherapy with monoclonal antibodies, such as atezolizumab and tiragolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Study doctors also want to learn if a tumor infiltrating T lymphocyte (TIL) response is helpful to determine the benefit of the combination of study drugs compared to the usual approach. TILs are a type of immune cell that has moved from the blood into a tumor. TILs can recognize and kill tumor cells. Giving atezolizumab with tiragolumab may be safe, tolerable and/or effective compared to atezolizumab alone in treating patients with recurrent glioblastoma. conditions: Recurrent Glioblastoma, IDH-Wildtype studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 52 type: ESTIMATED name: Atezolizumab name: Biospecimen Collection name: Magnetic Resonance Imaging name: Surgical Procedure name: Tiragolumab measure: Progression free survival (PFS) measure: Tumor infiltrating T lymphocyte density measure: Dose limiting toxicity measure: Incidence of adverse events measure: Objective response rate (ORR) measure: PFS6 measure: Overall survival measure: Tumor mutational burden (TMB) measure: Expression of immune checkpoint receptors and ligands measure: Tumor response signatures including for T-cells, interferon and cell cycle measure: T cell receptor (TCR) clonality and diversity measure: Tumor infiltrating T-cell, T-regs, and myeloid cells measure: TCR overlap and clonal expression measure: Peripheral blood mononuclear cell (PBMC) response signatures including for T-cells, interferon and cell cycle measure: TCR clonality by PBMC measure: TCR clonality measure: Trough concentrations in serum and concentrations in cerebrospinal fluid sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06328023 id: REC/MS-PT/01831 briefTitle: Impact of Concussion History on Sleep and Physical Performance in Contact Sports Athletes overallStatus: RECRUITING date: 2024-03-18 date: 2024-04-23 date: 2024-06-02 date: 2024-03-25 date: 2024-03-27 name: Riphah International University class: OTHER briefSummary: This study investigates the correlation between a history of concussions and its effects on both sleep patterns and physical performance among athletes engaged in contact sports. By examining the relationship between concussion history, sleep quality, and athletic performance, this research aims to provide insights into the potential long-term implications of concussions on the well-being and performance of athletes in contact sports conditions: Concussion, Mild conditions: Sleep conditions: Physical Performance studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 115 type: ESTIMATED name: SCOAT 6 to find association measure: Cantu Scale measure: Sport Concussion Office Assessment Tool 6 sex: ALL minimumAge: 18 Years maximumAge: 36 Years stdAges: ADULT facility: HAYATABAD Sports complex status: RECRUITING city: Peshawar state: Khyber Pakhtun Khawan zip: 24730 country: Pakistan name: Nadia Ishtiaq, MSOMPT role: CONTACT phone: 03486977541 email: Nadia.Ishtiaq@riphah.edu.pk name: Muhammad haroon, MSSPT* role: CONTACT phone: 03484644733 email: muhammad-haroon6528@zu.edu.pk name: Muhammad Haroon, MS*SPT role: PRINCIPAL_INVESTIGATOR lat: 34.008 lon: 71.57849 hasResults: False

 nctId: NCT06328010 id: SIDDXAC02 briefTitle: An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care in Medical Centers acronym: SIDDX overallStatus: ENROLLING_BY_INVITATION date: 2024-04-01 date: 2028-12-31 date: 2030-06-30 date: 2024-03-25 date: 2024-04-29 name: Siddhey LLC class: INDUSTRY briefSummary: Collect data on various wound treatments and their related wound healing process, in real life settings.

Analyze the safety and efficacy of wound treatments, including: advanced biological/synthetic grafts and standard of wound care treatments. conditions: Wounds and Injuries conditions: Burns conditions: Mohs Surgery conditions: Diabetic Foot Ulcer Mixed conditions: Venous Leg Ulcer conditions: Non-healing Wound conditions: Trauma Injury conditions: Injury and Wounds conditions: Degloving Injuries studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 5000 type: ESTIMATED name: Advanced Treatment Modalities for wound and injuries measure: Data collection of 5000 patients measure: Different types of wounds/injuries heal rate sex: ALL minimumAge: 21 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Comprehensive Medicine city: Alpine state: California zip: 91901 country: United States lat: 32.83505 lon: -116.76641 facility: West Hills Hospital and Medical Centers Doctors Suites city: West Hills state: California zip: 91307 country: United States lat: 34.19731 lon: -118.64398 hasResults: False

 nctId: NCT06327997 id: BZE2203-A-01 briefTitle: An Exploratory Study by Fast CAR T Cells overallStatus: RECRUITING date: 2024-03-07 date: 2027-03-06 date: 2027-12-31 date: 2024-03-25 date: 2024-03-25 name: Shanghai Cell Therapy Group Co.,Ltd class: INDUSTRY briefSummary: The main goal of this trial is to evaluate the safety and tolerability of CAR T cell therapy for advanced solid tumors with positive mesothelin and MUC1.Patients were screened, peripheral blood mononuclear cells (PBMC) were isolated from eligible patients, and cells were prepared. Pretreatment was performed within 5 days before infusion, and CAR T cells were infused on day 0 (the dose was determined according to the requirements of climbing/expansion). The safety intensive observation period was 28 days after infusion, and the clinical efficacy after infusion was evaluated on days 28-34. The follow-up observation and evaluation were carried out according to the follow-up visit point, and the follow-up period was 1 year. From the second year, the telephone follow-up period was entered. conditions: Solid Tumor studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Fast CAR T cells measure: Dose-limiting toxicity(DLT) measure: Maximum tolerated dose (MTD) measure: Objective response rate (ORR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Peak Plasma Concentration (Cmax) measure: AUC measure: Pharmacodynamics (PD) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Mengchao Cancer Hospital status: RECRUITING city: Shanghai state: Shanghai country: China name: Lou jinxing role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06327984 id: 157354 briefTitle: Barts Sex-CAD Database overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-05 date: 2027-05 date: 2024-03-25 date: 2024-03-25 name: Queen Mary University of London class: OTHER briefSummary: There is a lack of understanding of how Coronary Artery Disease (CAD) - meaning the blocking or furring up of the arteries of the heart - starts and progresses in women. In both men and women, CAD is the most common cause of heart attacks, which occur when the blood supply in the heart is interrupted (these are also known medically as 'acute coronary syndromes').

Before the menopause women appear to be protected from CAD; however, after the menopause that protection is lost. Also, those women who do suffer a heart attack have twice the risk of further heart attacks compared to men despite having the same treatment that works well in men. Biological differences between men and women are probably playing an important role in the way CAD develops. However, due to a lack of research there is currently little understanding of how the female body works in this area.

Inflammation is the body's natural response to injury or infection. Importantly it is also involved in the development of CAD. Hormones such as oestrogen and testosterone are also likely to be contributory factors. We think the differences between the way these hormones and inflammation play a part in CAD in both men and women are important, but the role they play is not yet fully understood.

In this study we wish to measure the 'markers' of inflammation in the blood of patients attending Barts Heart Centre with chest pain. We will also conduct questionnaires with these patients, to understand their hormone status and how parts of their medical history may be a contributory factor. For patients who have previously attended Barts Heart Centre will will contact them to conduct the questionnaire over the telephone only. We will combine this data with the data that is routinely collected during hospital admission. In this way we hope to understand whether inflammation together with hormone status plays an important role in CAD. Our hope is that through this research we will address an under researched area and find new ways of treating women and men with coronary artery disease. conditions: Coronary Artery Disease conditions: Myocardial Infarction conditions: Acute Coronary Syndrome conditions: Atherosclerosis conditions: Inflammation studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 6000 type: ESTIMATED measure: Mortality measure: Re-admission measure: MACE measure: Relationship with specific MI types measure: Relationship with inflammation sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06327971 id: 0000 briefTitle: Enhanced Outcome Prediction in Cutaneous Squamous Cell Carcinoma Using Deep-learning and Computational Histopathology overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-20 date: 2028-10 date: 2028-10 date: 2024-03-25 date: 2024-03-25 name: Queen Mary University of London class: OTHER briefSummary: Evaluate a deep-learning model trained on computational histopathology for predicting outcomes in cutaneous squamous cell carcinoma conditions: Squamous Cell Carcinoma of the Skin studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 300 type: ESTIMATED measure: Metastasis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Barts Health NHS Trust city: London country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06327958 id: protocol Number: 2021/21 briefTitle: THE EFFECTS OF DIRECT AND INDIRECT LARYNGOSCOPY ON CORMACK-LEHANE AND POGO SCORES overallStatus: COMPLETED date: 2021-09-15 date: 2022-06-15 date: 2022-06-30 date: 2024-03-25 date: 2024-03-25 name: Zonguldak Bulent Ecevit University class: OTHER briefSummary: Direct laryngoscopy (DL) is a conventional and highly difficult method that is used in endotracheal intubation (ETI) training. Today, the usage of video-laryngoscopes (VLs) to teach airway management to inexperienced healthcare personnel is a prevalent practice. In ETI training, it is recommended to train students on simulators before allowing them direct access to patients. conditions: Being a 5th Year Student at the Faculty of Medicine conditions: No Previous Laryngoscopy Experience studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 130 type: ACTUAL name: Cormack-Lehane (C&L) name: POGO score measure: The percentage of glottic opening (POGO) scores in the airway management training of medical students. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Zonguldak Bülent Ecevit University city: Zonguldak state: Kozlu zip: 67600 country: Turkey lat: 41.45139 lon: 31.79305 hasResults: False

 nctId: NCT06327945 id: 22-00009 briefTitle: Transplanting Lungs From Uncontrolled Donation After Circulatory Death overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-06-30 date: 2028-06-30 date: 2024-03-25 date: 2024-03-25 name: NYU Langone Health class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The study team developed an uncontrolled donation after circulatory death (uDCD) protocol that preserves lungs for just over 3 hours after death using positive end expiratory pressure (PEEP) and supplemental oxygen. The study will assess lung uDCD program safety by continuous review of operations/clinical records from each case activation and transplantation. Attrition outcomes include rates of initial and continued lung preservation, donation authorization, lung recovery, passing ex-vivo lung perfusion (EVLP) performance testing, and lung transplantation. Planned viability assessments also include macroscopic determination, radiology (X-ray), and fiber optic bronchoscopy before initiating EVLP. We expect \~50% of lungs assessed with EVLP will be transplanted to meet sustainability targets. Safety outcomes include the primary outcome, primary graft dysfunction (PGD) grade III at 72 hours, and secondarily survival one year after transplantation. conditions: Lung Transplantation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 24 type: ESTIMATED name: Lung uDCD Protocol measure: Incidence of Primary Graft Dysfunction (PDG) Grade III measure: Number of Participants who Required Normothermic Extracorporeal Membrane Oxygenation (nECMO) measure: Number of Participants who Required Normothermic Extracorporeal Membrane Oxygenation (nECMO) measure: Incidence of Re-Transplantation measure: Overall Survival measure: Overall Survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06327932 id: HIVEC(PRG) briefTitle: HIVEC in Patients With Non-Muscle-Invasive Bladder Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-31 date: 2028-03-31 date: 2024-03-25 date: 2024-03-25 name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University class: OTHER briefSummary: The purpose of this study is to determine the efficacy and safety of Hyperthermic Intravesical Chemotherapy (HIVEC) with Gemcitabine (GEM) after Transurethral Resection of Bladder Tumors (TURBT) in the treatment of medium or high-risk group Non-Muscle-Invasive Bladder Cancer (NMIBC). conditions: Non-Muscle-Invasive Bladder Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 320 type: ESTIMATED name: TURBT name: HIVEC name: Intravesical Chemotherapy name: Gemcitabine measure: Recurrence rate measure: 1-year recurrence rate measure: Recurrence-free survival (RFS) rate measure: Time to treatment failure measure: Success rate of therapeutic operation measure: Quality of international prostate symptom score measure: Quality of bother of score sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06327919 id: 62885 briefTitle: Effects of Probiotic Supplementation With Weight Reducing Plan in Patients With Food Addiction and Weight Regain After Bariatric Surgery overallStatus: COMPLETED date: 2022-06-01 date: 2023-05-25 date: 2023-09-23 date: 2024-03-25 date: 2024-03-25 name: National Nutrition and Food Technology Institute class: OTHER briefSummary: To study the effects of probiotic supplementation with a weight loss program and cognitive behavioral therapy (CBT) on anthropometric measures, eating behavior, food addiction, and related hormone levels in patients with food addiction and weight regain after bariatric surgery, 50 patients who referred to obesity clinic with weight regain (regaining ≥10% nadir weight) after bariatric surgery (at least 18 months), and food addiction will be randomly allocated to receive a weight loss program and CBT plus either probiotic, or placebo for 12 weeks. At the first and the end of the intervention, anthropometric measurements, eating behavior, food addiction, leptin, serotonin, and oxytocin will be assessed and compared between groups. conditions: Weight Regain After Bariatric Surgery and Food Addiction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ACTUAL name: Probiotic supplement name: Placebo supplement measure: Weight measure: BMI measure: Waist circumference measure: Fat mass measure: Food addiction measure: Eating behavior measure: Leptin measure: Serotonin measure: Oxytocin sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Azita Hekmatdoost city: Tehran state: Middle East zip: 19835 country: Iran, Islamic Republic of lat: 35.69439 lon: 51.42151 facility: National Nutrition and Food Technology Research Institute city: Tehran country: Iran, Islamic Republic of lat: 35.69439 lon: 51.42151 hasResults: False

 nctId: NCT06327906 id: qilu000002 briefTitle: A Prospective Birth Cohort of Infants With Allergy and Neurodevelopmental Disorders in China overallStatus: RECRUITING date: 2023-11-15 date: 2026-11-15 date: 2029-11-15 date: 2024-03-25 date: 2024-03-25 name: Qilu Hospital of Shandong University class: OTHER briefSummary: In this study, a birth cohort was established to demonstrate the causal relationship between allergies and neurodevelopment disorders in infants and young children, and to find out the influencing factors of neurodevelopment disorders in early life. conditions: Child Allergy conditions: Neurodevelopmental Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 6000 type: ESTIMATED measure: ASD measure: ADHD sex: ALL minimumAge: 1 Minute maximumAge: 42 Days stdAges: CHILD facility: Qilu Hospital of Shandong University status: RECRUITING city: Jinan state: Shandong country: China name: zhu mengna role: CONTACT phone: 15211482407 lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06327893 id: AQUATIC_RESCUE briefTitle: Patients Treated by the Danish Emergency Medical Services Following Non-drowning Water Rescues From 2016 to 2023 acronym: RESCUE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-05-01 date: 2024-03-25 date: 2024-03-25 name: Prehospital Center, Region Zealand class: OTHER briefSummary: Since 2015, all Danish prehospital EMS have used the nationwide Prehospital Electronic Medical Record (PEMR). In 2023, the investigators developed the Danish Drowning Formula (DDF), a text-search algorithm designed to search the unstructured text fields in the electronic medical records with comprehensive search criteria to identify all potential water-related incidents. This protocol describes the first study to analyse the prehospital data from a nationwide Danish cohort of patients treated by the EMS from 2016 to 2023 following non-drowning aquatic rescues. conditions: Drowning conditions: Drowning, Near conditions: Submersion conditions: Submersion - Accidental conditions: Submersion or Drowning Due to Being Washed Overboard conditions: Submersion or Drowning Due to Being Thrown Overboard conditions: Submersion or Drowning Due to Ship Sinking, Water Skier Injured conditions: Submersion or Drowning Due to Boat Submerging, Swimmer Injured conditions: Submersion or Drowning Due to Boat Overturning, Swimmer Injured conditions: Submersion or Drowning Due to Boat Submerging, Water Skier Injured conditions: Submersion or Drowning Due to Fall From Gangplank, Swimmer Injured conditions: Submersion or Drowning Due to Ship Sinking, Docker or Stevedore Injured conditions: Submersion or Drowning Due to Fall Overboard, Docker or Stevedore Injured studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3000 type: ESTIMATED name: Submersion or immersion in liquid measure: The annual incidence. measure: The annual incidence rate. measure: The spatial distribution of aquatic rescues on a map of Denmark. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Prehospital Center city: Næstved state: Region Zealand zip: 4700 country: Denmark lat: 55.22992 lon: 11.76092 hasResults: False

 nctId: NCT06327880 id: C4151006 id: 2023-509339-17-00 type: REGISTRY domain: CTIS (EU) briefTitle: A Study to Learn About the Study Medicine Called PF-07054894 in People of Japanese Origin overallStatus: NOT_YET_RECRUITING date: 2024-05-13 date: 2024-07-02 date: 2024-07-02 date: 2024-03-25 date: 2024-04-15 name: Pfizer class: INDUSTRY briefSummary: The purpose of this clinical study is to learn about the safety and effects of the study medicine (PF-07054894) in healthy Japanese participants.

The study is seeking the following participants:

* Male or female Japanese participants aged 18 years or older. The participants should be healthy after going through some medical tests.
* Have a Body Mass Index (BMI) of 16 to 32 kilogram per meter squared; and a total body weight of more than 45 kilograms (100 pounds).
* Are willing and able to follow all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

In research, the participants in clinical studies are assigned by chance to separate groups that are given different treatments. Hence participants will be by chance assigned to receive either PF-07054894 or a harmless treatment that has no medical effect (placebo). Both these will be taken by mouth for 14 days. The total duration of the study is about 11 weeks, with a follow-up via telephone about 6 weeks after first treatment. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 6 type: ESTIMATED name: PF-07054894 or placebo measure: Number of participants with adverse events (AE) or serious adverse events (SAE) measure: Number of participants with clinically meaningful change from baseline in laboratory tests results measure: Number of participants with clinically meaningful change from baseline in vital signs measure: Number of participants with clinically meaningful change from baseline in electrocardiogram (ECG) parameters measure: Maximal plasma concentration (Cmax) measure: Time to Maximum Plasma Concentration (Tmax) measure: Area Under the Plasma Concentration-Time Profile From Time Zero (AUCτ) To End of Dosing Interval (AUCt) measure: Half-life of PF-07054894 measure: Observed Accumulation Ratio (Rac) measure: Observed Accumulation Ratio Based on Cmax (Rac,Cmax) measure: Trough plasma concentrations (Ctrough) measure: Apparent Volume of Distribution (Vz/F) as data permits measure: Apparent Oral Clearance (CL/F) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pfizer Clinical Research Unit - Brussels city: Brussels state: Bruxelles-capitale, Région DE zip: B-1070 country: Belgium lat: 50.85045 lon: 4.34878 hasResults: False

 nctId: NCT06327867 id: drs2402021836 briefTitle: Comparison of Video Laryngoscopy Versus Direct Laryngoscopy for Orotracheal Intubation Among Adults in Emergency Department overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-03-01 date: 2025-05-01 date: 2024-03-25 date: 2024-04-11 name: Patan Academy of Health Sciences class: OTHER briefSummary: This is an open-label, single center, prospective, randomized, comparative, intervention study.

The goal of this study is to compare the success rate of video laryngoscopy vs direct laryngoscopy for first pass oro tracheal intubation. The other question it aims to answer are:

1. To assess the adverse events during video laryngoscopy
2. To assess the adverse events during direct Laryngoscopy
3. To compare the first pass success rate of DL vs VL according to demographic profile (age and sex) conditions: To Compare Success Rate of Video Laryngoscopy vs Direct Laryngoscopy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: An open-label, single center, prospective, randomized, comparative, intervention study. primaryPurpose: TREATMENT masking: NONE count: 126 type: ESTIMATED name: Oro Tracheal Intubation by DL name: Oro Tracheal Intubation by VL measure: First pass success of direct laryngoscopy in oro tracheal intubation measure: First pass success of video laryngoscopy in oro tracheal intubation measure: Complications rates between two methods. measure: Use of alternative methods for ventilation or oxygenation between two methods measure: Better visualization of Cormack-Lehane grading between two methods sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06327854 id: NUOROS (PI: M Briguglio) id: L4175 type: OTHER_GRANT domain: Italian Ministry of Health briefTitle: NUtrition and ORal Health in Orthopaedic Surgery overallStatus: RECRUITING date: 2024-03-18 date: 2024-03-22 date: 2024-12-10 date: 2024-03-25 date: 2024-03-25 name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio class: OTHER briefSummary: This prospective observational study evaluates the relationship between the objective oral health status and the patient reported diet in 64 adult patients undergoing elective major orthopaedic surgery (hip, knee, or spine surgery). conditions: Orthopedic Disorder conditions: Metabolism and Nutrition Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 64 type: ESTIMATED measure: Association between pre-operative oral health and diet sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio status: RECRUITING city: Milan country: Italy name: Elena Cittera role: CONTACT phone: 00390283502224 email: elena.cittera@grupposandonato.it name: Matteo Briguglio role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06327841 id: EK 1117/2022 briefTitle: Plaque Reduction Sesame Oil overallStatus: COMPLETED date: 2022-06-21 date: 2022-08-18 date: 2022-08-18 date: 2024-03-25 date: 2024-03-25 name: Medical University Innsbruck class: OTHER briefSummary: The goal of this clinical trials to learn about potential additives in reducing dental plaque. The main questions it aims to answer is:

• is there a difference in the plaque reducing effect of oil pulling with sesame oil compared to rinsing with distilled water? Participants will rinse with 15 ml of their allocated liquid for 15 min every morning for 8 weeks.

Researchers will compare sesame oil against distilled water to see if there is a difference in the plaque reducing effect. conditions: Dental Plaque conditions: Gingivitis conditions: Oral Microbial Colonization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: sesame oil name: distilled water measure: Rustogi Modified Navy Plaque Index (RMNPI) measure: Gingival Index (GI) measure: microbial analysis measure: Oral Health Impact Profile (OHIP) measure: Interview halitosis, xerostomia sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University city: Innsbruck state: Tyrol zip: 6020 country: Austria lat: 47.26266 lon: 11.39454 hasResults: False

 nctId: NCT06327828 id: 32-663 briefTitle: Methimazole in Graves' Disease - a Randomised Controlled Trial Comparing the Computer-aided Treatment DigiThy Versus Usual Care overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-10-01 date: 2026-10-01 date: 2024-03-25 date: 2024-03-25 name: Medical University of Graz class: OTHER name: Graz University of Technology briefSummary: The goal of this clinical trial is to compare two methods of guiding methimazole therapy in patients with Graves' disease: methimazole dose adjustments based on a new semi-automated computer-guided treatment (based on a mathematical model) or based on the treating physician's decision (i.e. usual care). The main question it aims to answer is whether semi-automated computer-guided treatment is not inferior to usual care in terms of safety, the time it takes to achieve euthyroidism and the methimazole dose required. conditions: Graves Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 52 type: ESTIMATED name: Semi-automated computer-aided treatment (Digital Thyroid, DigiThy) name: Usual care measure: The primary aim is to compare semi-automated computer-guided treatment with usual care in terms of their performance indices measure: Comparison in terms of dosing and penalties measure: Comparison based on free thyroxine (fT4) target range sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Graz city: Graz zip: 8044 country: Austria name: Verena Theiler-Schwetz, MD, PhD role: CONTACT lat: 47.06667 lon: 15.45 hasResults: False

 nctId: NCT06327815 id: D1690L00149 briefTitle: Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM overallStatus: RECRUITING date: 2024-03-27 date: 2025-04-30 date: 2025-04-30 date: 2024-03-25 date: 2024-04-15 name: AstraZeneca class: INDUSTRY briefSummary: Study D1690L00149 is a 24-week, multicentre, randomized, parallel, interventional, non-inferiority, open-label study designed to compare the FDC Regimen of Dapagliflozin/Metformin XR with the Dapagliflozin co-administered with Metformin XR in glycemic lowering control, satisfaction and adherence in Chinese patients with T2DM. conditions: Type 2 Diabetes Mellitus (T2DM) studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 632 type: ESTIMATED name: Xigduo (Dapagliflozin and Metformin hydrochloride extended-release) tablets name: Dapagliflozin tablets and Metformin HCl extended-release tablets measure: Change in HbA1c from baseline measure: Proportion of patients achieved HbA1c less than 7.0% from baseline to week 24. measure: Absolute change in FPG from baseline to week 24. measure: Absolute change in PPG from baseline to week 24. measure: The difference in satisfaction scores between 2 groups measured with the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at week 24. measure: The difference in quality of life between 2 groups measured with Diabetes Quality of Life (DQOL) questionnaire at week 12 and week 24. measure: To evaluate the difference in adherence of FDC versus co-administered dual therapy by Morisky Medication Adherence Scale-8 (MMAS-8) questionnaire in Chinese patients with T2DM. measure: AEs measure: SAE measure: ADRs measure: Temperature measure: Systolic and diastolic BP measure: Pulse rate measure: Respiratory rate measure: Weight measure: Height measure: BMI measure: Number of participants with abnormal ECG readings measure: Proportion of TITR (Time in Tight Target Range) measure: TIR (Time In Range) measure: TBR (Time Below Range) measure: TAR (Time Above Range) measure: MAGE (Mean Amplitude of Glycemic Excursion) measure: SDBG (Standard Deviation of Blood Glucose) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: RECRUITING city: Beijing zip: 100020 country: China lat: 39.9075 lon: 116.39723 facility: Research Site status: NOT_YET_RECRUITING city: Wei Fang zip: 261035 country: China hasResults: False

 nctId: NCT06327802 id: 20240104 briefTitle: Improving the Well-being of Caregivers of Cystic Fibrosis Patients During Physiotherapy Treatment acronym: MucoZar overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2025-07-31 date: 2024-03-25 date: 2024-03-25 name: Pole Sante Grace de Dieu class: OTHER briefSummary: The main objective of the study is to determine the impact of cystic fibrosis affecting a child on the parents' quality of life, their possible anxiety and depressive symptoms, their general fatigue and the feeling of burden in these caregivers. conditions: Cystic Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 360 type: ESTIMATED name: Questionnaire measure: Zarit Burden Interview sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PSLA GDD city: Caen zip: 14000 country: France lat: 49.18585 lon: -0.35912 hasResults: False

 nctId: NCT06327789 id: ZBEU-MS briefTitle: Trunk Control and Disability in Persons With Multiple Sclerosis overallStatus: COMPLETED date: 2021-12-21 date: 2021-12-25 date: 2022-02-21 date: 2024-03-25 date: 2024-03-25 name: Zonguldak Bulent Ecevit University class: OTHER briefSummary: This study aims to investigate the relationship between physical disability and trunk control, balance, and pedobarographic parameters in persons with Relapsing Remitting Multiple Sclerosis (RRMS) who have a low Expanded Disability Status Scale (EDSS) score. Twenty-three RRMS patients with an age range of 18-50 years, EDSS score ≤ 3 were included in this study. The patients' level of disability (EDSS), trunk control )Trunk Impairment Scale - TIS), lower extremity functionality (Timed 25-Foot Walk Test - T25FW), upper extremity functionality (Nine Hole Peg Test- 9HPT), balance (Biodex Balance System) and gait (Zebris® FDM 2) were evaluated. conditions: Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 23 type: ACTUAL measure: Expanded Disability Status Scale (EDSS) measure: Trunk Impairment Scale (TIS) measure: Biodex Balance System (BBS) (MedicalSystems, Shirley, NY, USA) measure: Step Length (cm) measure: Stride Length (cm) measure: Step Width (cm) measure: Cadence (steps/min) measure: Velocity (m/s) measure: Step time (s) measure: Stride time (s) measure: Timed 25-Foot Walk Test (T25FW) measure: Nine-Hole Peg Test (9HPT) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Zonguldak Bülent Ecevit University city: Zonguldak country: Turkey lat: 41.45139 lon: 31.79305 hasResults: False

 nctId: NCT06327776 id: 21/709 briefTitle: New Protein Biomarkers and Technology for Improving Diagnosis and Outcome Prediction in Mild TBI overallStatus: RECRUITING date: 2022-03-04 date: 2025-07-31 date: 2025-12-31 date: 2024-03-25 date: 2024-03-25 name: Hospital Universitario 12 de Octubre class: OTHER briefSummary: Mild traumatic brain injury(mTBI) is a common cause of consultation to the emergency rooms worldwide and is the most common form of traumatic brain injury. Though classified as mild, as many as 40% of patients suffering mTBI do not make complete recoveries or present persistent symptoms. The present study is intended to determine long term outcome of patients suffering mTBI and to establish new prognostic models with the use of serum and saliva based biomarkers. For this purpose this study will not exclude patients regarding their comorbidities. conditions: Mild Traumatic Brain Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Serum and saliva biomarkers measure: Biomarkers diagnostic performance measure: Determination of the potential of the biomarkers in predicting neurological symptoms after TBI measure: Determination of the potential of the biomarkers in predicting neurological outcome assessed by the Extended Glasgow Outcome Score (GOSE) after TBI measure: Determination of the potential of the biomarkers in predicting quality of life assessed by Qolibri-OS after TBI measure: Determination of the potential of the biomarkers in predicting quality of life assessed by EQ-5D-5L after TBI measure: Determination of the potential of the biomarkers in predicting quality of sleep assessed by the Epworth and Pittsburgh Scales sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario 12 de Octubre status: RECRUITING city: Madrid zip: 28041 country: Spain name: Alfonso Lagares, MD, PhD role: CONTACT phone: +34917792389 email: alfonso.lagares@salud.madrid.org lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06327763 id: Ilioinguinal Neurectomy briefTitle: Prophylactic Ilioinguinal Neurectomy During Open Tension-Free Inguinal Hernia Repair overallStatus: COMPLETED date: 2022-01-01 date: 2023-06-01 date: 2023-06-01 date: 2024-03-25 date: 2024-03-25 name: Zagazig University class: OTHER_GOV briefSummary: postoperative chronic inguinal pain is a common postoperative complication after open inguinal hernia repair.

Chronic inguinal pain is a common complication following open inguinal hernia repair. Ilioinguinal nerve entrapment is a common cause of this chronic pain which may adversely affect the patients' life. Ilioinguinal neurectomy seems to be beneficial in preventing such pain, but it carries the risk for numbness and hypoesthesia. conditions: Ilioinguinal Nerve Section conditions: Pain Prevention conditions: Hernioplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 196 type: ACTUAL name: ilioinguinal nerve section measure: detect postoperative pain using short form inguinal pain questionnaire sex: MALE minimumAge: 16 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: yasmine Hegab city: Zagazig zip: 7120730 country: Egypt lat: 30.58768 lon: 31.502 hasResults: False

 nctId: NCT06327750 id: NL83566.018.24 briefTitle: The Microcirculation, Dialysis Modality and Sequestered Salt acronym: MIMOSA overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-12 date: 2027-12 date: 2024-03-25 date: 2024-03-25 name: Amsterdam UMC, location VUmc class: OTHER name: Dutch Kidney Foundation name: Niercentrum aan de Amstel name: B.Braun Avitum AG briefSummary: The aim of this clinical trial is to investigate the effect of 5 different dialysis treatments (combinations of dialysis mode and dialysis fluid sodium content) on the microcirculation (MC) and sequestered sodium content (SSC) in adult prevalent end-stage kidney disease (ESKD) patients treated with hemodialysis (HD) or hemodiafiltration (HDF). The main questions it aims to answer are:

1. What are the effects on the sequestered sodium content and microcirculation after 4 weeks of treatment with the following dialysis modes?

   * HDF with an expected zero diffusive sodium balance (Dialysate sodium concentration (DNa)= Plasma sodium concentration (PNa)) compared to
   * HDF with an expected diffusive sodium efflux (DNa \< PNa, difference 3 mmol/L) compared to
   * HD with an expected zero diffusive sodium balance (DNa = PNa) compared to
   * HD with an expected diffusive sodium efflux (DNa \< PNa, difference 3 mmol/L) compared to
   * Isolated ultrafiltration for 30 minutes followed by HD with an expected zero diffusive sodium balance (DNa = PNa)
2. Are the SSC and MC interrelated in this patient group?

This study is a randomized cross-over trial. Participants will be subjected to the abovementioned dialysis treatment modes in random order. conditions: End-stage Renal Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized cross-over trial primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: Hemodialysis (DNa = PNa) name: Hemodialysis (DNa<PNa) name: Hemodialysis after isolated ultrafiltration (DNa=PNa) name: High volume hemodiafiltration (DNa=PNa) name: High volume hemodiafiltration (DNa<PNa) measure: Skin microcirculation measure: Sequestered salt content (SSC) measure: Intradialytic hypotension measure: Change in intradialytic blood pressure measure: Peridialytic blood pressure measure: Change in CK-MB measure: Change in high sensitivity C-reactive protein (hs-CRP) measure: Change in interleukin-6 receptor (IL-6R) measure: Change in soluble CD163 (sCD163) measure: Change in soluble intercellular adhesion molecule-1 (s-ICAM-1) measure: Change in serum glycosaminoglycans measure: Change in syndecan-1 measure: Change in vascular endothelial growth factor C (VEGF-C) measure: Change in extracellular vesicles (EVs) measure: Change in skin microcirculation measure: Change in sequestered salt content (SSC) measure: modified Dialysis symptom index (mDSI) measure: Thirst distress scale (TDS) measure: EQ Visual analogue scale (EQ VAS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06327737 id: AKDENIZ-KAEK-916 briefTitle: Diabetic Ketoacidosis Diagnosis and Management overallStatus: COMPLETED date: 2020-12-15 date: 2022-11-15 date: 2023-03-15 date: 2024-03-25 date: 2024-03-25 name: Akdeniz University class: OTHER name: Ceren Kahraman briefSummary: This is the first and only study conducted on the use of capnography in children diagnosed with DKA to evaluate the initial clinical grading of DKA, monitor clinical improvement, and predict complications such as brain edema. conditions: Metabolic Acidosis conditions: Diabetic Ketoacidosis conditions: Brain Edema studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 55 type: ACTUAL name: Capnography measure: Correlation between PCO2 and EtCO2 measure: Correlation between Integrated Pulmonary Index and degree of acidosis measure: Prediction of cerebral edema with Integrated Pulmonary Index sex: ALL minimumAge: 15 Days maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Akdeniz University city: Antalya country: Turkey lat: 36.90812 lon: 30.69556 hasResults: False

 nctId: NCT06327724 id: 12434 briefTitle: Belimumab in SLE Synovial Inflammation and Lymph Nodes overallStatus: RECRUITING date: 2023-09-01 date: 2025-01-01 date: 2025-03-01 date: 2024-03-25 date: 2024-03-25 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER name: GlaxoSmithKline briefSummary: Systemic lupus erythematosus (SLE)is an immune-mediated inflammatory disease (IMIDs) of which the cellular and molecular alterations of the immune system driving the diseases still remains largely unknown. Accordingly, it remains difficult to predict the individual patient's response to treatment. Moreover, the patient's response to treatment remains heterogeneous and difficult to predict, despite the development of a variety of novel and powerful drugs (including the so-called biologicals). Therefore, there is a clear need for the identification and validation of cellular and molecular biomarkers which can provide useful clinical information for diagnosis, classification, prognosis and treatment, as well as the development of new therapeutic strategies. Biomarkers can be found and analyzed in different body compartments, of which the peripheral blood and the intra-articular synovial fluid or tissue are most easily accessible. However, previous studies in RA and other IMIDs showed that adaptive immune responses in other tissues such as lymph nodes also play an important role. Investigating other immune compartments of the body such as the lymph nodes could result in new insights. To study the early pathogenesis of inflammatory conditions, in 2008 our department initiated core-needle inguinal lymph node biopsy sampling. Since then more than 100 lymph node biopsy procedures were performed. The procedure is well-tolerated and, other than a small hematoma which does not require therapy in most of the cases, no complications were reported.

In the current study, the effects of belimumab (anti-BAFF) in SLE will be investigated by studying the immune alterations taking place in lymph nodes in comparison to peripheral blood and immune alterations taking place in the end-organ, e.g. the joint (wrist, knee or ankle) by taking synovial biopsies during a needle- or mini-arthroscopy. This procedure has been performed frequently in our department over the last 15 years. In this way immune alterations in the lymph nodes (secondary lymphoid organ), peripheral blood (systemic) and the joint (end organ for the disease) will be assessed and compared. conditions: Systemic Lupus Erythematosus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 15 type: ESTIMATED name: Belimumab measure: Differences in lymph node cellular composition as assessed by advanced flow cytometry measure: Differences in peripheral blood cellular composition as assessed by advanced flow cytometry measure: Differences in synovial tissue cellular composition as assessed by advanced flow cytometry sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC; location Academic Medical Center status: RECRUITING city: Amsterdam zip: 1100DD country: Netherlands name: Sander W Tas, Prof. dr. role: CONTACT phone: +31 20 56 67765 email: secr-reumatologie@amsterdamumc.nl lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06327711 id: BL77 briefTitle: Benefits of Nutritional Ingredients for Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-03 date: 2024-03-25 date: 2024-03-25 name: Abbott Nutrition class: INDUSTRY briefSummary: This is a prospective randomized, double-blinded, parallel design study to evaluate the benefits of long-term consumption of two experimental blends of liquid supplements. conditions: Diabetes type2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2 groups, non-crossover primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 114 type: ESTIMATED name: Control: CHO Blend name: Experimental: CHO Blend plus AN100 measure: Matsuda Index measure: Fasted Glucose measure: Fasted Insulin measure: Body Weight measure: Body Composition Measurements measure: Continuous Glucose Monitoring measure: Glycated Hemoglobin measure: Resting Energy Expenditure (REE) measure: Microbiome - Fecal measure: Microbiome - Saliva measure: Waist Circumference measure: Hip Circumference measure: Conicity Index measure: Blood Pressure measure: Accelerometry Data measure: Diabetes Distress Scale measure: Dietary Intake measure: Blood biomarkers - inflammation measure: Urine biomarkers - inflammation sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06327698 id: AK104-IIT-C-S-0010 briefTitle: Cadonilimab in Combination With Anlotinib in the Treatment of Locally Progressive or Metastatic Melanoma With First-Line Therapy Failure overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2026-05-31 date: 2027-05-31 date: 2024-03-25 date: 2024-03-25 name: Hunan Cancer Hospital class: OTHER briefSummary: This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of cadonilimab (AK104) in combination with anlotinib in the treatment of locally advanced or metastatic melanoma. conditions: Melanoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Cadonilimab name: anlotinib measure: Response Rate measure: Progression-free Survival (PFS) measure: Disease Control Rate (DCR) measure: Safety and tolerability sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06327685 id: MCC-22318 briefTitle: Avapritinib With Decitabine in Patients With SM-AHN overallStatus: RECRUITING date: 2024-03-13 date: 2027-03 date: 2027-03 date: 2024-03-25 date: 2024-04-09 name: H. Lee Moffitt Cancer Center and Research Institute class: OTHER name: Blueprint Medicines Corporation briefSummary: Systemic mastocytosis with an associated hematologic neoplasm (SM-AHN) is a challenging disease to treat. Targeted KIT inhibitors have been approved for this indication based on their ability to control the mastocytosis portion of the disease, but patients frequently experience progression of the concomitant myeloid malignancy (i.e. the AHN). Using a combination approach to treat both aspects of the disease has the potential to provide enhanced disease control; however, overlapping toxicity is a concern. In this study, investigators aim to study the safety and tolerability of combined avapritinib and decitabine for the treatment of SM-AHN. conditions: Systemic Mastocytosis With an Associated Hematologic Neoplasm studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 34 type: ESTIMATED name: Avapritinib name: Decitabine name: Decitabine/Cedazuridine measure: Recommended phase 2 dose (RP2D) measure: Systemic mastocytosis overall response rate (ORR) measure: Overall Responsive Rate measure: Incidence and frequency of AEs and changes in vital signs, ECGs, and laboratory tests sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic - Arizona status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85054 country: United States name: Cecilia Arana Yi, MD role: CONTACT name: Cecilia Arana Yi, MD role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: Stanford University Medical Center status: NOT_YET_RECRUITING city: Palo Alto state: California zip: 94305 country: United States name: Jason Gotlib, MD role: CONTACT name: Jason Gotlib, MD role: PRINCIPAL_INVESTIGATOR lat: 37.44188 lon: -122.14302 facility: Moffitt Cancer Center status: RECRUITING city: Tampa state: Florida zip: 33612 country: United States name: Caroline Wagstaff role: CONTACT phone: 813-745-5197 email: Caroline.Wagstaff@moffitt.org name: Andrew Kuykendall, MD role: PRINCIPAL_INVESTIGATOR name: Onyee Chan role: SUB_INVESTIGATOR name: Rami Komrokji role: SUB_INVESTIGATOR name: Timothy Kubal role: SUB_INVESTIGATOR name: Jeffrey Lancet role: SUB_INVESTIGATOR name: Eric Padron role: SUB_INVESTIGATOR name: David Sallman role: SUB_INVESTIGATOR name: Alison Walker role: SUB_INVESTIGATOR name: Seongseok Yun role: SUB_INVESTIGATOR lat: 27.94752 lon: -82.45843 facility: Dana-Farber Cancer Institute status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Daniel DeAngelo, MD, PhD role: CONTACT name: Daniel DeAngelo, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: University of Michigan status: NOT_YET_RECRUITING city: Ann Arbor state: Michigan zip: 48109 country: United States name: Kristen Pettit, MD role: CONTACT name: Kristen Pettit, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 facility: Memorial Sloan Kettering Cancer Center status: NOT_YET_RECRUITING city: New York state: New York zip: 10065 country: United States name: Raajit Rampal, MD, PhD role: CONTACT name: Raajit Rampal, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: University of Utah Health status: NOT_YET_RECRUITING city: Salt Lake City state: Utah zip: 84132 country: United States name: Tsewang Tashi, MD role: CONTACT name: Tsewang Tashi, MD role: PRINCIPAL_INVESTIGATOR lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06327672 id: 162023 briefTitle: INOCA Spanish National Registry acronym: ESP-INOCA overallStatus: RECRUITING date: 2024-03-24 date: 2025-03 date: 2026-03 date: 2024-03-25 date: 2024-03-28 name: Eva Rumiz González class: OTHER name: Hospital San Carlos, Madrid name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa name: Hospital Universitario Virgen de la Arrixaca name: University Hospital Gregorio Marañón name: Hospital Clínico Universitario de Valladolid name: Hospital Universitario Puerta del Mar name: Hospital Universitari de Bellvitge name: Hospital Universitario La Fe name: Hospital Clínico Universitario de Valencia name: Hospital Universitario La Paz name: Hospital General Universitario de Alicante name: Complejo Hospitalario Universitario de Huelva name: Hospital General Universitario de Castellón name: Hospital de Manises name: Hospital Clinic of Barcelona name: Hospital Miguel Servet name: Hospital Clínico Universitario Lozano Blesa name: Hospital Universitario Donostia name: Hospital General Universitario Elche name: Hospital Universitario Virgen del Rocio name: Hospital de la Ribera name: Hospital de la Santa creu i Sant Pau - Barcelona name: Hospital Virgen de la Salud name: Hospital Universitario San Juan de Alicante name: Hospital Universitario de Torrevieja name: University Hospital of the Nuestra Señora de Candelaria name: Hospital de Basurto name: Hospital Universitario Ramon y Cajal name: Hospital Universitario Fundación Jiménez Díaz name: Puerta de Hierro University Hospital name: Hospital Universitario 12 de Octubre name: University of Salamanca name: Hospital Universitario Marqués de Valdecilla name: Hospital Clinico Universitario de Santiago name: Complexo Hospitalario Universitario de A Coruña briefSummary: Coronary atherosclerosis is the most common cause of ischaemic heart disease. About 40-50% of patients with symptoms and documented ischaemia on non-invasive tests do not show obstructive coronary artery disease on coronary angiography. This cause of ischaemic heart disease called INOCA (Ischemic Non-Obstructive Coronary Artery), far from having a benign prognosis, is associated with an increase in major adverse cardiac events (MACE) as well as increased functional limitation. The current European Society of Cardiology clinical practice guidelines for the management of chronic coronary syndrome establish for the first time a IIa recommendation for the invasive analysis of coronary flow reserve (CFR) and microvascular resistance index (MRI) in symptomatic patients with INOCA. The acetylcholine (Ach) test, based on intracoronary (ic) administration, is established as indication IIb for the assessment of micro or macrovascular vasospasm in patients with suspected vasospastic angina (VSA) (4). A national multicentre registry would allow us to determine the prevalence of INOCA and its different endotypes in our setting. conditions: Non-Obstructive Coronary Atherosclerosis conditions: Ischemia conditions: Coronary Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: Prevalence of INOCA endotypes. measure: Incidence of combined event: death from all causes, acute myocardial infarction, readmission for heart failure and consultation for chest pain in the emergency department. measure: Targeted pharmacological treatment measure: Prognostic markers. measure: INOCA and risk of heart failure with preserved ejection fraction. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario de la Princesa status: RECRUITING city: Madrid country: Spain name: Fernando Rivero Crespo, MD role: CONTACT lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Virgen de Arrixaca status: RECRUITING city: Murcia country: Spain name: Ramón Lopez Palop, MD role: CONTACT lat: 37.98704 lon: -1.13004 facility: Hospital General Universitario de Valencia status: RECRUITING city: Valencia country: Spain name: Eva Rumiz Gonzalez, MD, PhD role: CONTACT phone: +34 626068935 email: evarumizgonzalez@gmail.com lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06327659 id: Thrombectomy by 50 ml syringe briefTitle: Efficacy of Using 50 ml Syringe Manual Thrombectomy Catheter in Primary PCI With Heavy Thrombus Burden overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-01 date: 2025-01-01 date: 2024-03-25 date: 2024-03-26 name: Helwan University class: OTHER briefSummary: In high thrombus burden subgroup of Acute STEMI, manual aspiration thrombectomy was associated with reduced cardiovascular death but increased stroke or transient ischemic attack. The role of aspiration thrombectomy is still a matter of active debate. Manual aspiration suffers from decreasing aspiration force as the syringe fills with fluid and requires the operator to exchange syringes during the procedure to maintain suction. conditions: STEMI - ST Elevation Myocardial Infarction conditions: Thrombosis Cardiac studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 88 type: ESTIMATED name: 30 mL syringe manual thrombectomy catheter name: 50 mL syringe manual thrombectomy catheter measure: TIMI flow grade after PCI measure: MBG after PCI measure: Composite rate of occurrence of MACE measure: Rate of cardiovascular death measure: Rate of recurrent myocardial infarction measure: Rate of stroke measure: Rate of cardiogenic shock measure: Rate of NYHA IV heart failure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Badr University Hospital city: Badr state: Cairo country: Egypt name: Arafa Gomaa, MD role: CONTACT name: Arafa Gomaa, MD role: PRINCIPAL_INVESTIGATOR hasResults: False

 nctId: NCT06327646 id: 66677 briefTitle: Maternal Adherence to MMS in Nepal acronym: NAMASTE MMS overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-07-20 date: 2024-07-20 date: 2024-03-25 date: 2024-03-25 name: Helen Keller International class: OTHER name: Eleanor Crook Foundation briefSummary: Although clinical studies highlight the value of MMS for pregnant and lactating women, implementation research studies are necessary to understand adherence and acceptability to the product and to uncover potential obstacles to implementation in specific contexts. For Nepal, it is crucial to establish whether adherence to MMS supplementation is non-inferior to the existing IFA supplementation for 180 tablets, which has a high (65%) adherence rate. It is also important to investigate how whether providing MMS in bottles (containing a substantial quantity, such as 90 count bottles twice during pregnancy) might impact ANC utilization, particularly in terms of ensuring that pregnant women attend at least eight ANC visits. Furthermore, assessment of MMS acceptability, including pill taste, smell, size, swallowability, side effects, benefits as well as aspects such as product labeling and packaging, among end users in Nepal, is needed to understand acceptability of MMS vs. IFA. Finally, implementation issues within the health system, including the need of trainings for healthcare workers' and, female community health volunteers (FCHVs)' training needs; and government stakeholders' interest and barriers;; community s Social and behavioral change communication needs, and issues around supply chain issues should be well-understood and documented to inform prior to scale-up to support a smooth transition of MMS. Thus, Helen Keller International, in collaboration with Nepal's Ministry of Health and Population (MoHP) and the Eleanor Crook Foundation (ECF), will conduct a set of four mixed-methods studies to generate evidence and insights that inform the development of an MMS supplementation strategy. This trial in one province of Nepal is the first study that will be complemented by one additional quantitative study and two qualitative studies to generate evidence on the topics mentioned. conditions: Supplementation conditions: Pregnancy Related conditions: Postnatal Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 2640 type: ESTIMATED name: Multiple Micronutrient Supplement Blister name: Multiple Micronutrient Supplement Bottle name: Iron Folic Acid Blister measure: 180 days adherence: MMS (2 types) vs. IFA measure: 30, 90, and 225 days adherence measure: 180 adherence: MMS blister vs MMS bottle measure: MMS acceptability measure: Antenatal Care Utilization at 180 days sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06327633 id: ZZ2024 briefTitle: Effects of Olfactory Training on the Brain Function in T2DM Patients With Mild Cognitive Impairment overallStatus: RECRUITING date: 2024-01-01 date: 2024-08-01 date: 2024-08-01 date: 2024-03-25 date: 2024-03-26 name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School class: OTHER briefSummary: This is a pilot, prospective, randomized, open label, parallel, 4-month study to explore and evaluate the therapeutic effects of olfactory training on the cognitive function, olfactory function, and odor-induced brain activation in T2DM patients with mild cognitive impairment (MCI). conditions: Type 2 Diabetes Mellitus conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Olfactory Training measure: Change of olfactory brain activation by fMRI measure: Change of cognitive function measure: Olfactory threshold test measure: Change of metabolism sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University status: RECRUITING city: Nanjing state: Jiangsu zip: 210008 country: China name: Yan Bi, MD, PhD role: CONTACT phone: 86-25-83-105302 email: biyan@nju.edu.cn name: YAN BI, MD, PhD role: PRINCIPAL_INVESTIGATOR name: ZHOU ZHANG, MD, PhD role: SUB_INVESTIGATOR lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06327620 id: A002021015 briefTitle: Treatment Of Oral Lichen Planus overallStatus: RECRUITING date: 2022-01-15 date: 2024-05-20 date: 2024-05-20 date: 2024-03-25 date: 2024-03-25 name: Mansoura University class: OTHER briefSummary: This novel project aims to explore an alternative treatment for oral lichen planus (OLP), a challenging condition with limited therapeutic options. The proposed treatment involves the topical application of Daivobet ointment, a combination of calcipotriol (vitamin D analog) and betamethasone (corticosteroid), which has shown promising results in the treatment of psoriasis Vulgaris.

The study will involve 15 patients aged 30-60 years with clinically confirmed intra-oral erosive lichen planus, some of whom have not responded to current therapies. Participants will apply Daivobet ointment three times daily for four weeks, with clinical assessments conducted at the beginning, and at the end of the second and fourth weeks.

Inclusion criteria require the presence of bilateral oral erosive lichen planus lesions, with clinical and histopathological confirmation based on the World Health Organization's modified definition. Exclusion criteria include histological signs of dysplasia, use of drugs possibly causing lichenoid reactions, recent treatment for OLP, and hypersensitivity to the study drug.

Clinical evaluations will employ a scoring system based on lesion characteristics, including ulceration, erythema, and reticulation, measured with a calibrated grid. Subjective responses will be assessed through discomfort scores on a visual analog scale, and a questionnaire will capture any adverse effects. Digital photographs will document visual changes, and incisional biopsies will be performed to confirm the diagnosis.

The project aims to provide valuable insights into the efficacy and safety of the Daivobet ointment as a potential alternative treatment for oral lichen planus, offering hope for improved outcomes for patients suffering from this challenging condition. conditions: Lichen Planus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 15 type: ESTIMATED name: Daivobet ointment, topical steroids measure: Clinical Improvement of Oral Lichen Planus Lesions measure: Objective Response Score measure: Subjective Response Score sex: ALL minimumAge: 30 Years maximumAge: 60 Years stdAges: ADULT facility: Mansoura University, Faculty of Dentistry status: RECRUITING city: Mansoura state: Dakahlia zip: 35516 country: Egypt name: Mona Montaser role: CONTACT email: mmontaser@mans.edu.eg lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06327607 id: IEO 1952 briefTitle: Psychosexuological Interventions to Support Sexual Function in Breast Cancer Patients overallStatus: RECRUITING date: 2023-06-09 date: 2024-12-31 date: 2024-12-31 date: 2024-03-25 date: 2024-03-25 name: European Institute of Oncology class: OTHER briefSummary: Prospective pilot study on the feasibility and efficacy of a brief psychosexual support intervention in breast cancer patients undergoing hormonal therapies for at least 6 months.

The study is randomized in the two following arms:

Control arm (standard care pathway) Psychosexual intervention arm conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 82 type: ESTIMATED name: Control Group name: Psychosexological intervention measure: Evaluation of differences between two arms in female sexual satisfaction and functionality scores measure: Evaluation of differences between two arms in levels of quality of life measure: Evaluation of differences between two arms in levels of anxiety and depression measure: Evaluation of differences between two arms in levels of sleep quality sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Gabriella Pravettoni role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06327594 id: XTang-0002 briefTitle: Assessment System of Sarcopenia in Lung Cancer Patients overallStatus: RECRUITING date: 2023-11-01 date: 2027-11 date: 2028-11 date: 2024-03-25 date: 2024-03-25 name: West China Hospital class: OTHER briefSummary: 1. To explore the diagnostic value of musculoskeletal cross-modal imaging assessment system of ultrasound combined with abdominal CT/MRI for sarcopenia in patients with lung cancer.
2. To explore the value of musculoskeletal cross-modal imaging assessment system of ultrasound combined with abdominal CT/MRI in evaluating the prognosis and the effect of nutritional support in patients with lung cancer during perioperative period.
3. To explore the value of musculoskeletal cross-modal imaging assessment system of ultrasound combined with abdominal CT/MRI in evaluating the long-term prognosis of patients with lung cancer. conditions: Sarcopenia conditions: Lung Cancer conditions: Ultrasound studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 1500 type: ESTIMATED name: ultrasound scan name: CT/MRI scan measure: Death measure: Perioperative complications sex: ALL minimumAge: 40 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xinyi Tang status: RECRUITING city: Chengdu state: Sichuan country: China name: Xinyi Tang, Dr. role: CONTACT phone: +8615680819215 lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06327581 id: 101005 briefTitle: Combined Microneedling With Either 1% Lactic Acid Solution or Vitamin D3 or Triamcinolone Acetonide in The Treatment of Alopecia Areata overallStatus: RECRUITING date: 2023-12-15 date: 2024-09-23 date: 2024-12-22 date: 2024-03-25 date: 2024-03-25 name: Zagazig University class: OTHER_GOV briefSummary: Alopecia areata (AA) is an immunologically mediated disease characterized by non-scarring hair loss (Madni and Shapiro, 2000). AA is presented by rapid and complete hair loss in one or more round or oval patches, usually on the scalp, beard area, eyebrows, eyelashes, and less commonly, on other hairy areas of the body (Berker et al., 2010 and James et al., 2011) Alopecia areata is a T-cell-mediated autoimmune disease. There is a complicated interplay between loss of immune privilege in the hair follicle, autoimmune-mediated hair follicle damage, and activation of inflammatory pathways that have been argued to explain the development of this disorder, but the exact pathophysiology of AA remains unknown. Hair follicles are infiltrated by autoreactive CD8 and CD4 T lymphocytes, which attack hair follicle-derived autoantigens while sparing the stem compartment (Rajabi et al., 2018).

Alopecia areata can be treated with topical and/or intralesional corticosteroids, which are the treatment of choice. Anthralin, minoxidil, coal tar, and topical immunotherapy are examples of other topical treatments. Systemic immunosuppressants such as cyclosporine, systemic steroids, Janus kinase inhibitors, and methotrexate may be considered in severe resistant cases (lee and lee, 2017).

Intralesional triamcinolone acetonide is preferred in cases of AA , as it is well known as anti-inflammatory and interferes with local immunity of the skin, which helps in the recovery of the disease, but if used in wrong technique or given in a high dose, it might cause all the side effects of corticosteroid, especially skin atrophy (Berker et al., 2010).

Lactic acid is a member of alpha-hydroxy acids. It has been used in the treatment of many skin diseases, like AA and vitiligo. Lactic acid stimulates spontaneous secretion of vascular endothelial growth factor (VEGF) by human reconstructed epidermis. VEGF is an angiogenic cytokine involved in angiogenesis and wound healing and stimulates the growth of hair follicles resulting in recovery of AA. Other studies suggest that lactic acid may act through its irritant effect (Al-Tammimy, 2005).

Vitamin D interacts with the innate and adaptive immune systems in a variety of ways, the majority of which contribute to its downregulation (Nancy and Yehuda, 2009). It has a powerful effect on T and B lymphocytes, influencing their activation responses (Arnson et al., 2007).

All cells of the immune system express 1,25-dihydroxyvitamin D3 receptors (VDRs) and are therefore vulnerable to calcitriol-mediated modulation. Vitamin D3 has the ability to influence the migration and maturation of different dendritic cell subtypes and their production of chemokines and cytokines, giving them an immunoregulatory and tolerogenic role (Illescas-Montes et al., 2019) It has been shown that VDRs are highly expressed in the keratinocytes of human hair follicles and the absence of their expression is associated with reduced hair follicle growth and epidermal differentiation. Reduced VDR expression in the hair follicles of affected areas has also been observed in studies of AA patients' scalp (Çerman et al., 2015).

Microneedling (MN) is a technique that comprises puncturing the skin repeatedly with sterile microneedles (Iriarte et al., 2017). It promotes hair regeneration by triggering stem cells in the hair bulge, which results in the generation of growth factors. It also improves blood circulation to the hair follicles and influences the local immune cells (Chandrashekar et al., 2014). Moreover, combining MN with applied topical drugs facilitates their absorption through the microchannels created within the epidermis (Fertig et al., 2018). conditions: Alopecia Areata studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 44 type: ESTIMATED name: Lactic Acid name: vit D name: Triamcinolone Acetonide name: Saline measure: hair regrowth improvement assessed by 5-point semiquantitative regrowth score (RGS) sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Rana Ehab status: RECRUITING city: Zagazig zip: 44519 country: Egypt name: rana ehab, md role: CONTACT phone: 01000896453 email: ranaehab015@gmail.com lat: 30.58768 lon: 31.502 hasResults: False

 nctId: NCT06327568 id: IEO 1663 briefTitle: Anal Cancer and/or Precancer Screening: Performance Analysis of the BD Onclarity™ HPV Assay on Anal Specimens overallStatus: RECRUITING date: 2022-06-17 date: 2026-06-17 date: 2029-06-17 date: 2024-03-25 date: 2024-03-26 name: European Institute of Oncology class: OTHER briefSummary: Human papillomavirus (HPV) infection has been implicated as a necessary cause for the development of the majority of anogenital neoplasms which represent approximately 95% of anal tumors. Persistent high risk HR-HPV infection promotes progression from intraepithelial lesions high-grade squamous anal tumors (AIN) (H-SIL) to invasive anal tumors.

The diagnosis of AIN is made by cytology or biopsy during routine examinations. To date, no HPV test has been clinically validated for anal specimens and none are available in the molecular diagnostics market for this purpose.

The performance analysis of an HPV Test with simultaneous genotyping on anal samples could implement anal cancer screening without an invasive procedure and with one simple approach. conditions: Anal Intraepithelial Neoplasia 2 conditions: Anal Intraepithelial Neoplasia 1 conditions: Anal Cancer conditions: High-Risk Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Sensitivity and specificity of BD Onclarity HPV assay for HPV detection and genotyping in case/control patients. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Fabio Bottari role: CONTACT name: Cristina Trovato, MD role: SUB_INVESTIGATOR name: Anna Daniela Iacobone, MD role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06327555 id: M2023123 briefTitle: Study on the Effect of Telerehabilitation Using Wearable Devices After ACL Reconstruction overallStatus: RECRUITING date: 2023-09-01 date: 2024-12-31 date: 2025-06-30 date: 2024-03-25 date: 2024-03-25 name: Peking University Third Hospital class: OTHER briefSummary: Trial purpose: To evaluate the safety and effectiveness of using a new remote rehabilitation platform for postoperative rehabilitation in patients with anterior cruciate ligament rupture compared to conventional rehabilitation care through a randomized controlled trial.

Test subjects: This study is a multicenter study that recruited 252 participants from three centers (aged ≥ 18 years) for cruciate ligament rupture reconstruction; Exclude patients who have undergone revision and bilateral surgery, and exclude patients with collateral ligament and posterior cruciate ligament injuries in the knee joint.

Trial plan: The subjects were randomly enrolled and randomly divided into two groups: the remote rehabilitation group and the traditional rehabilitation group, using a mixed block randomization method. The probability of being divided into both groups was 50%. All subjects received routine outpatient diagnosis and treatment, with the same content. The remote rehabilitation group uses software and sensors to provide remote postoperative rehabilitation guidance. The traditional rehabilitation group receives routine rehabilitation diagnosis and treatment, with face-to-face rehabilitation twice a week. All subjects are required to undergo regular follow-up (1 day before surgery, 3 months after surgery, 6 months).

Outcome measures: The main outcome measures were knee isokinetic muscle strength and Lysholm knee joint score . the secondary outcome measures were Y-balance test, Tegner activity scale, health survey summary table (SF-36),The other outcome measures were Anterior Cruciate Ligament Return to Sport After Injury (ACL-RSI) Scale, vas pain score. conditions: Anterior Cruciate Ligament Reconstruction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 252 type: ESTIMATED name: the traditional rehabilitation group name: the remote rehabilitation group measure: the Lysholm Knee Scoring Scale measure: knee Isokinetic strength measure: Y-balance balance test measure: Tegner score measure: the 36-item Short Form Health Survey(SF-36) measure: Anterior Cruciate Ligament Return to Sport After Injury (ACL-RSI) Scale measure: VAS pain score sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: quan Jian Wang status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: quan J Wang, M.D. role: CONTACT phone: 13801076267 email: wjqsportsmed@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06327542 id: 22-37078B id: 1R61MD018333 type: NIH link: https://reporter.nih.gov/quickSearch/1R61MD018333 briefTitle: Group-based Integrative Pain Management in Primary Care Safety Net Clinics acronym: IPMP+ overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-30 date: 2027-04-30 date: 2024-03-25 date: 2024-03-26 name: University of California, San Francisco class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: Socioeconomically disadvantaged populations have a high prevalence of chronic pain, exacerbated by social isolation, intersectional stigma, and disparities in pain assessment and treatment options. Effective interventions using a multilevel, biopsychosocial approach are needed to decrease the unequal burden of pain. The proposed study will test group-based integrative models of pain management in primary care safety net clinics to improve pain care for racially and ethnically diverse low-income patients. conditions: Chronic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: 2x2 factorial trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 360 type: ESTIMATED name: Group Acupuncture name: Integrative Group Medical Visits measure: Change in pain impact measured as a composite score of pain intensity, pain interference, and physical function. measure: Change in Social support and Pain Questionnaire (SPQ) measure: Change in average pain intensity on the 0-10 numeric rating scale measure: Self-reported pain interference will be measured using the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) scale. Total t-scores range from 0 to 100, with higher scores indicating greater levels of pain interference. measure: Change in physical function on the 6-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 6b measure: Change in Internalized Stigma of Chronic Pain (ISCP) survey measure: Change in social isolation on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Social Isolation Short Form 8a measure: Change in pain self efficacy on the Pain Self-Efficacy Questionnaire (PSEQ) measure: Change in pain catastrophizing on the Pain Catastrophizing Scale (PCS) 6-item short form measure: Change in depressive symptoms on the Patient Health Questionnaire (PHQ-9) measure: Change in anxiety on the Generalized Anxiety Disorder survey (GAD-2) measure: Patient belief about treatment efficacy on the Patient Global Impression of Change (PGIC) measure: Change in health-related quality of life on NIH Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale measure: Change in experiences of discrimination in healthcare sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tom Waddell Urban Health Clinic city: San Francisco state: California zip: 94102 country: United States name: Jesse Wennik, NP role: CONTACT lat: 37.77493 lon: -122.41942 hasResults: False

 nctId: NCT06327529 id: 2101814 briefTitle: Zinc and Iron Absorption From Common Beans in Young Adult Women overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-31 date: 2024-12-31 date: 2024-03-25 date: 2024-03-26 name: University of California, Davis class: OTHER briefSummary: Fifteen female study participants will be enrolled in a randomized crossover study to measure fractional and total zinc and iron absorption from four common bean (Phaseolus vulgaris) varieties with varying phytate and polyphenolic contents. Phytate, the storage form of phosphorus in plants, and polyphenols, which contribute to the varied colors of common beans, are natural components of the beans and can reduce zinc and iron bioavailability from these foods. conditions: Zinc Absorption conditions: Iron Absorption studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A four arm multi-tracer non-randomized crossover design primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Study participants will be masked to the type of bean that they will be receiving. whoMasked: PARTICIPANT count: 15 type: ESTIMATED name: SER 118 name: LMP 1001 name: LPA 586 name: KAT B1 measure: Fractional Zinc absorption measure: Fractional Iron absorption measure: Total Zinc absorption measure: Total Iron absorption sex: FEMALE minimumAge: 19 Years maximumAge: 24 Years stdAges: ADULT facility: Department of Nutrition city: Davis state: California zip: 95616 country: United States lat: 38.54491 lon: -121.74052 hasResults: False

 nctId: NCT06327516 id: M2020023 briefTitle: Lysophosphatidylglycerol in Asthma Pathogenesis overallStatus: RECRUITING date: 2015-01-01 date: 2024-12-31 date: 2025-06-30 date: 2024-03-25 date: 2024-03-26 name: Peking University Third Hospital class: OTHER briefSummary: The study aims to investigate the relationship between the small molecule metabolite lysophosphatidylglycerol and asthma clinical features and explore its involvement in asthma pathogenesis. conditions: Asthma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 250 type: ESTIMATED measure: lipidomics sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking university third hospital status: RECRUITING city: Beijing state: None Selected zip: 100191 country: China name: Chun Chang role: CONTACT phone: 15810075362 email: doudou1977bysy@sina.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06327503 id: 36/7-2024 briefTitle: Salivary Signal Molecules for Neural and Vascular Homeostasis in T2DM overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-30 date: 2024-06-30 date: 2024-03-25 date: 2024-03-27 name: University of Belgrade class: OTHER briefSummary: Various signal molecules are detected in blood and tissues of patients with T2DM, that are important for the function of neural tissue in diabetic setting. Among them, specifically important are neuroprotective and neurotrophic growth factors such as nerve growth factor (NGF), glial cells - derived neurotrophic factor (GDNF) and brain-derived neurotrophic factor (BDNF). Furthermore, several other signal molecules are discovered to affect vascular tissues homeostasis in T2DM, including soluble alpha-klotho (s-Klotho), vascular endothelial growth factor (VEGF) and interleukin-6 (IL-6). Most of these molecules are also detected in saliva in various states and diseases of orofacial system, but data about their levels in saliva of T2DM patients are lacking, although neural and vascular diabetic complications are present in orofacial tissues and organs. Also, there is no data about presence and levels of s-Klotho in saliva of healthy or T2DM patients, although it was reported that this molecule exerts protective effect on the salivary glands tissue. Salivary opiorphin is recently discovered pentapeptide, primarily isolated from saliva. It acts as an inhibitor of the enzymes that perform degradation of endogenous antinociceptive molecules enkephalins, affecting nociceptive signal transduction. This may be of special importance since some intraoral complications of T2DM (e.g. burning mouth) may have underlying peripheral neural changes as a pathophysiological mechanism. Against this background, the aim of the study is to detect the presence and levels of mentioned signal molecules in saliva of patients with and without T2DM. conditions: Type 2 Diabetes studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED name: saliva samples collecting measure: NGF levels in saliva measure: GDNF levels in saliva measure: BDNF levels in saliva measure: s-Klotho levels in saliva measure: VEGF levels in saliva measure: IL-6 levels in saliva measure: opiorphin levels in saliva measure: unstimulated saliva flow sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Belgrade School of Dental Medicine city: Belgrade zip: 11000 country: Serbia name: Marija S Milic, DDS Ph.D role: CONTACT phone: +381112646280 phoneExt: 122 email: marija.milic@stomf.bg.ac.rs lat: 44.80401 lon: 20.46513 hasResults: False

 nctId: NCT06327490 id: UF-BRE-012 briefTitle: A Study Evaluating the Feasibility and Compliance of Manual Lymphatic Drainage Comparing Indocyanine-Green (ICG) Guided vs. Traditional Guided in Patients Undergoing Axillary Node Dissection for the Treatment of Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-06 date: 2028-06 date: 2024-03-25 date: 2024-04-22 name: University of Florida class: OTHER briefSummary: Breast cancer is estimated to affect approximately 300,000 women in the US in 2023. Studies demonstrate that 1 in 5 will develop breast cancer related lymphedema secondary to the treatments that they receive. BCRL at this time has no cure, however early detection can prevent the progression to late stage BCRL. At this time a technique of arm massage, manual lymphatic drainage (MLD), is used for treatment. This study investigates a new method of MLD, which is guided by the individual patients' lymphatic anatomy through use of ICG-lymphography. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: ICG-guided manual lymphatic drainage name: Traditional manual lymphatic drainage measure: Subject compliance measure: Relative volume change measure: Bioimpedance measure: Breast cancer related lymphedema symptoms measure: Incidence of progression to late stage breast cancer related lymphedema measure: Health-related quality of life sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Florida city: Gainesville state: Florida zip: 32610 country: United States name: Lisa Spiguel, MD role: PRINCIPAL_INVESTIGATOR lat: 29.65163 lon: -82.32483 hasResults: False

 nctId: NCT06327477 id: NU 23S01 id: NCI-2024-01927 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: STU00220015 id: NU 23S01 type: OTHER domain: Northwestern University id: P30CA060553 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA060553 briefTitle: Proton-Spatially Fractionated Radiotherapy and Standard Radiation Therapy for the Treatment of Newly Diagnosed Retroperitoneal Soft Tissue Sarcoma overallStatus: RECRUITING date: 2024-04-02 date: 2027-07-01 date: 2028-07-01 date: 2024-03-25 date: 2024-04-26 name: Northwestern University class: OTHER name: National Cancer Institute (NCI) briefSummary: This phase I/II trial studies the side effects and best dose of proton-spatially fractionated radiotherapy (P-SFRT) and to see how well it works with standard radiation therapy in treating patients with newly diagnosed retroperitoneal soft tissue sarcoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Standard spatially fractionated radiotherapy (SFRT) refers to how the radiation is delivered to the tumor. SFRT means that different parts of the tumor are receiving different doses of radiation (fractionation) through beams that allow areas of higher and lower (peaks and valleys) of doses of the radiation. This spatial fractionation allows an overall high-dose radiation to be given in the peaks and those areas of the tumor may release cells and substances that may help with killing tumor cells, reducing tumor symptoms and shrinking tumors. Proton therapy is a type of radiation therapy that can overcome some of the barriers of standard SFRT. Protons are tiny radioactive particles that can be controlled in a beam to travel up to the tumor and, compared to the particles used in standard radiotherapy, proton therapy can deliver higher doses to the tumor because smaller doses of radiation are delivered to tissues away from the tumor. This allows radiation therapy dose-escalated (continuously increasing the dose of radiation) treatment to tumors even though the tumor is near radiation sensitive organs like the colon. Giving P-SFRT with standard radiation therapy may work better in treating patients with newly diagnosed retroperitoneal soft tissue sarcoma. conditions: Retroperitoneal Sarcoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Intensity-Modulated Radiation Therapy name: Resection name: Spatially-fractionated Radiation Therapy measure: Recommended phase II dose (Phase I) measure: Pathological complete response (Phase II) measure: Incidence of adverse events (Phase I) measure: Overall response rate (ORR) (Phase II) measure: Progression-free survival (PFS) (Phase II) measure: Overall survival (OS) ( (Phase II) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwestern University status: RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Seth M. Pollack role: CONTACT phone: 312-695-6180 name: Seth M. Pollack, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06327464 id: 23-03228 briefTitle: Exogenous Ketones and Appetite overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-01 date: 2025-04-01 date: 2024-03-25 date: 2024-04-04 name: University of British Columbia class: OTHER briefSummary: People with obesity have different appetitive responses to stimuli compared to people without obesity. For example, people with obesity have a blunted postprandial ghrelin ('hunger' hormone) response, lower glucagon-like peptide 1 (GLP-1) and peptide-YY (PYY; associated with satiety) compared to people without obesity. Given the favorable effects of exogenous ketones on appetite previously observed in healthy adults of normal body weight, it is possible that these supplements can alter appetite hormones in a manner that may closer match that observed in people without obesity. To explore this research question, investigators will conduct a randomized single-blind cross over study to characterize appetite and dietary intake after ingestion of an exogenous ketone supplement within adults with obesity (compared a control condition without exogenous ketones) and compared to adults without obesity. The research team will also explore differences in postprandial energy expenditure and fuel utilization. Twenty-two healthy young- and middle-aged adults will be included (up to n=26 enrolled). In addition to a baseline visit to measure body composition, participants will undergo two 4.5-hour study visits, one of which will include a ketone diol supplement and one will have a placebo. Participants will be given a 1-day run-in diet prior to each study day to support energy balance. On each study day visit, participants will undergo a resting metabolic rate test (indirect calorimetry) followed by a fasting appetite rating and blood sample collection. Participants will then be provided with a standard breakfast meal (one with the ketone supplement and one with placebo). Appetite ratings and blood sample collection will be repeated 60, 120, and 180 minutes after the meal. Indirect calorimetry will be completed after the 30, 90, and 150 minute assessments. After the 180-minute timepoint, participants will be provided with a buffet-like lunch meal with instructions to eat as much or as little as they would like to determine ad libitum dietary intake at a single meal. To assess free-living ad libitum dietary intake, participants will receive 1.5 days of food boxes tailored to their preferences, with uneaten food returned at the end of the 1.5-day period. This study will be the first to assess the impact of exogenous ketones on appetite in obesity and would help inform future weight loss intervention trials. conditions: Appetite conditions: Obesity conditions: Ketones conditions: Appetitive Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 22 type: ESTIMATED name: Exogenous ketones measure: Acylated ghrelin area under the curve (AUC) measure: Peptide-YY(3-36) area under the curve (AUC) measure: Glucagon-like peptide 1 area under the curve (AUC) measure: Insulin area under the curve (AUC) measure: Glucose area under the curve (AUC) measure: Leptin area under the curve (AUC) measure: Hunger rating from visual analog scale measure: Satiety rating from visual analog scale measure: Prospective food consumption rating from visual analog scale measure: Desire to eat rating from visual analog scale measure: Dietary energy intake at a single meal measure: Free-living dietary energy intake measure: Postprandial energy expenditure sex: ALL minimumAge: 19 Years maximumAge: 45 Years stdAges: ADULT facility: University of British Columbia - Okanagan city: Kelowna state: British Columbia zip: V1V1V7 country: Canada name: Sarah Purcell, PhD role: CONTACT phone: 2508079827 email: sarah.purcell@ubc.ca lat: 49.88307 lon: -119.48568 hasResults: False

 nctId: NCT06327451 id: IRB2024-YX-037-01 briefTitle: Evaluate the Efficacy and Safety of Atorvastatin Combined With Temozolomide in the Treatment of Glioblastoma overallStatus: RECRUITING date: 2024-04-01 date: 2026-02-28 date: 2027-02-28 date: 2024-03-25 date: 2024-03-25 name: Tianjin Medical University General Hospital class: OTHER briefSummary: Glioblastoma (GBM) is the primary intracranial malignant tumor with the highest morbidity and mortality, and the 5-year survival rate is less than 10%. The number of primary diagnostic patients and deaths of GBM in China ranks first in the world every year, which seriously threatens people's life and health. At present, the clinical treatment strategy of maximum surgical resection combined with concurrent chemo- and radio-therapy and TTF treatment is still not satisfactory, and the median survival time of GBM patients is only 14.4 months. Statins inhibit cholesterol production with few side effects and are widely used for cholesterol control in patients with hyperlipidemia. In recent years, statins have shown good anti-tumor effect. Our previous study found that statins can block the malignant progression of glioma mediated by EGFR pathway. Therefore, the investigators report a clinical study protocol designed to evaluate the clinical efficacy of a comprehensive treatment strategy of atorvastatin (ATO) combined with temozolomide (TMZ) in primary and recurrent glioblastomas with high EGFR expression.

The investigators designed a multicenter, single-arm, double-blind, phase II clinical trial to evaluate the efficacy and safety of oral ATO combined with TMZ in EGFR-high expressing GBM. After informed consent was signed by the patient or authorized family members, the patients were treated with the current STUPP regimen and ATO (20mg, qn) orally. The patients were regularly followed up for 52 weeks after treatment. The primary endpoint was progression-free survival (PFS), which was defined as the time from the start of GBM surgery to tumor progression (recurrence) or death. The secondary end point was the rate of tumor control, which was defined as the proportion of patients with a complete response, a partial response, or a stable disease that had shrunk or remained stable for a given period of time. Safety will be assessed during the study by monitoring of regular MRI scans, laboratory tests (liver function, lipid profile, blood routine), electrocardiography, vital signs (blood pressure, pulse, temperature), and weight.

The results of this clinical trial will provide key information on whether the oral combination of atorvastatin and temozolomide prolongs PFS in EGFR-high GBM patients with efficacy and safety. conditions: Glioblastoma, IDH-wildtype studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Atorvastatin 20mg measure: progression-free survival measure: Overall survival measure: Tumor control rate measure: Hepatic burden of GBM patients after receiving atorvastatin administration measure: Percentage of participants with treatment-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Tianjin Medical University General Hospital status: RECRUITING city: Tianjin zip: 300052 country: China name: Chunsheng Kang role: CONTACT phone: +8602260817499 email: kang97061@tmu.edu.cn name: Xiaoteng Cui role: CONTACT phone: +8602260817481 email: xiaotengcui@tmu.edu.cn lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06327438 id: REC/211/MTI.PT/2401041 briefTitle: Effect of Complex Decongestive Therapy, Cryotherapy and Kinesio Taping in Patients With Post-mastectomy Lymphedema: A Randomized Control Trial overallStatus: RECRUITING date: 2024-03-16 date: 2024-06-16 date: 2024-07-16 date: 2024-03-25 date: 2024-03-25 name: South Valley University class: OTHER briefSummary: To examine the efficacy of complex decongestive therapy (CDT), cryotherapy and kinesio taping (KT) in patients with post-mastectomy lymphedema conditions: Breast Neoplasms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled study primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Complex decongestive therapy name: Cryotherapy name: Kinesio taping measure: Arm girth measurement is measured by Circumferential measurements measure: Pain severity is measured by VAS measure: The QOL is measured by SF-36 measure: Range of motion (ROM) is measured by UG sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: Ragaee Saeed Mahmoud status: RECRUITING city: Giza state: Faisal country: Egypt name: Ragaee Mahmoud role: CONTACT phone: 00201223611112 email: ragaeesaeedpt10@gmail.com name: Reham Mahmoud role: CONTACT phone: 00201015447798 email: rsm_211pt@yahoo.com lat: 30.00808 lon: 31.21093 facility: Ragaee Saeed Mahmoud status: RECRUITING city: Faisal state: Giza zip: 002 country: Egypt name: Reham Saeed, Doctora role: CONTACT phone: 00201223611112 email: rsm_Pt211@yahoo.com name: Rabab Saeed, Doctora role: CONTACT phone: 00201017855222 email: rababSaeed10@yahoo.com lat: 30.01744 lon: 31.20376 hasResults: False

 nctId: NCT06327425 id: MCG-Tachyarrhythmia briefTitle: MCG for Localization of Tachyarrhythmia's Origin overallStatus: NOT_YET_RECRUITING date: 2024-03-14 date: 2024-12 date: 2025-02 date: 2024-03-25 date: 2024-03-25 name: Qilu Hospital of Shandong University class: OTHER briefSummary: This is an exploratory research aiming to accurately identify the site of origin of tachyarrhythmia using Magnetocardiography (MCG), which will have guiding significance for early diagnosis, the formulation of treatment plans and preoperative positioning for radiofrequency ablation. conditions: Tachyarrhythmia conditions: Atrial Flutter conditions: Paroxysmal Supraventricular Tachycardia conditions: Atrial Tachycardia conditions: Atrial Fibrillation conditions: Premature Ventricular Contraction studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 1000 type: ESTIMATED name: Magnetocardiography measure: Efficacy of MCG to detect the site of origin of Tachyarrhythmia using cardiac electrophysiology as a reference standard. sex: ALL minimumAge: 18 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06327412 id: KayseriCHLYMP01 briefTitle: The Effects of Aerobic Exercise in Patients With Primary Lower Extremity Lymphedema overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-10-01 date: 2024-03-25 date: 2024-03-27 name: Kayseri City Hospital class: OTHER_GOV briefSummary: Our aim in this study is to evaluate the effects of lymphedema on exercise capacity, body composition, functional level and quality of life in lymphedema patients with primary lower extremity involvement. conditions: Primary Lymphedema conditions: Aerobic Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A total of 35 patients with primary stage 2 and 3 lower extremity lymphedema, aged 18-65, who apply to the lymphedema outpatient clinic and meet the criteria of the International Society of Lymphology, will be included. Patients participating in the study will be randomized into 2 groups: aerobic exercise group (Group 1) and home exercise group (Group 2). According to randomization, 18 patients will be included in one group and 17 patients in the other.

Cardiopulmonary exercise test (CPET), 30-second-stand-sit test (30s-CST), 6-minute walk test (6MWT), Lymphedema Circumference and Volume Measurement, Bioimpedance Measurement, Lower Extremity Functional Scale (LEFS), Lymphedema Life Impact Scale ( LLIC), Hospital Depression and Anxiety Scale (HADS), Numerical Rating Scale (NRS) forms will be filled in the cardiopulmonary rehabilitation unit of Kayseri City Hospital in the 0th, 4th and 16th weeks. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 35 type: ESTIMATED name: Aerobic exercise on the treadmill name: Walking between 12-13 RPE (The Borg Rating of Perceived Exertion) according to the Modified Borg Scale measure: 30-second sit-stand test (30-s chair-stand test, 30s-CST) measure: Cardiopulmonary exercise test (CPET) measure: 6-minute walk test (6MWT) measure: Circumference and volume measurement measure: Bioimpedance measurement measure: Lower Extremity Functional Scale (LEFS) measure: Lymphedema Life Impact Scale (LLIC) measure: Hospital Anxiety and Depression Scale (HADS) measure: Numerical Rating Scale (NRS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital city: Kayseri zip: 38080 country: Turkey lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06327399 id: MS-373-2023 briefTitle: Dexmedetomidine Infusion Dose Versus Rapid Bolus Dose Before Tracheal Intubation. overallStatus: RECRUITING date: 2024-01-21 date: 2024-04 date: 2024-05 date: 2024-03-25 date: 2024-03-25 name: Kasr El Aini Hospital class: OTHER briefSummary: Dexmedetomidine bolus dose may provide similar or less hemodynamic changes (less bradycardia and less hypertension) than infusion dose during induction of anaesthesia and tracheal intubation. conditions: Dexmedetomidine conditions: Intubation Complication studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Dexmedetomidine infusion name: Dexmedetomidine bolus name: Atropine Sulfate name: Ephedrine name: Propofol measure: Mean blood pressure upon laryngoscopy measure: Blood pressure & Heart rate measure: Propfol measure: Bradycardia sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Cairo University Hospitals status: RECRUITING city: Giza zip: 11562 country: Egypt name: Maher a Fawzy, MD role: CONTACT phone: 01201730249 email: kasralainirec@kasralainy.edu.eg lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06327386 id: 202434 briefTitle: The Therapeutic Efficacy of 18F-FDG Combined With 18F-FAPI PET/MR in Neoadjuvant Therapy for Gastric Cancer overallStatus: RECRUITING date: 2024-01-01 date: 2026-01-01 date: 2026-01-01 date: 2024-03-25 date: 2024-03-25 name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University class: OTHER briefSummary: Gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer-related deaths. Although surgical treatment can benefit the survival of the vast majority of patients, currently only early gastric cancer patients can be cured directly through endoscopic resection or surgery alone. Neoadjuvant therapy reduces tumor volume and improves tumor response rate through preoperative radiotherapy and chemotherapy, thereby increasing R0 resection rate and improving overall survival, without increasing postoperative complications and mortality. Timely imaging re staging during neoadjuvant therapy can allow patients to enter the surgical stage earlier, thereby reducing their preoperative burden. According to the different stages of neoadjuvant therapy, clinical staging can be divided into baseline stage (cBSstage) and clinical rest stage (cReStage) after neoadjuvant therapy.

At present, the conventional imaging methods for diagnosing cBStage in gastric cancer include CT, endoscopic ultrasonography (EUS), and MRI. The NCCN guidelines recommend CT for cBStage, with a diagnostic accuracy of 77.1% to 88.9%. Similarly, EUS and MRI were also used for cBStage, with accuracy rates of 65.0% to 92.1% and 71.4% to 82.6%, respectively. The application of diffusion-weighted imaging (DWI) has improved the accuracy of MRI diagnosis of cBStage to 93%.

However, due to the destruction of the gastric wall structure by neoadjuvant therapy, accurate imaging re staging is difficult. Currently, accurate tumor regression grading can only be obtained through surgical resection of pathological specimens. For cReT after neoadjuvant therapy, the diagnostic accuracy of EUS is only 63% (T2: 44%, T3: 68%, T4: 90%). Due to the presence of chronic inflammatory reactions, such as tumor cell apoptosis, necrosis, fibrosis, etc., in both the tumor and the critical normal gastric wall after neoadjuvant therapy, imaging cannot accurately identify the level of gastric wall, leading to the current low value of CT for cReT. Meanwhile, due to the fact that the pathological reactions of lymph nodes after neoadjuvant therapy are mainly subacute inflammatory reactions accompanied by scar tissue formation, and not all lymph node volumes that experience these pathological reactions will rapidly decrease, the accuracy of CT diagnosis of cReN is only 44%, while the sensitivity and specificity of EUS diagnosis of cReN are 50% and 56%, respectively.

In addition, positron emission tomography (PET) can reflect the abnormal metabolism, protein synthesis, DNA repair, and cell proliferation of tumors at the molecular level, providing important information in tumor grading diagnosis, prognosis evaluation, treatment decision-making, and efficacy monitoring. The conventional positron tracer 18F-FDG can reflect the glucose metabolism ability of different tissues, while most types of malignant tumors exhibit high metabolism. Therefore, 18F-FDG can be used for the diagnosis, staging, and treatment monitoring of cancer. However, in gastric cancer patients, 18F-FDG has certain limitations, including 1) interference with physiological or inflammatory uptake of the gastric wall; 2) Low uptake of 18F-FDG is present in signet ring cell carcinoma, mucinous adenocarcinoma, or other poorly differentiated cancers with high mucus content; 3) There are cases of false positive FDG after immunotherapy. In the study of SUV changes in the tumor area before and after treatment, it was found that patients with postoperative pathological regression grades 1-5 Δ SUVs are between 0-70%.

Tumor associated fibroblasts are closely related to tumor growth, invasion, and distant metastasis, and their activation requires the involvement of fibroblast activation protein (FAP). Therefore, radiolabeled fibroblast activation protein inhibitor (FAPI) can achieve in vivo FAP targeted tracing and quantification by specifically binding to FAP. Currently, a large number of studies have shown that 18F-FAPI is superior to 18F-FDG in the staging and re staging of gastric cancer. Furthermore, prospective studies have shown a certain relationship between tumor regression grade (TRG) and 18F-FAPI rate of change parameters (SUVmax, SUVavg, SUVR).

Therefore, in the early stage of this study, 18F-FAPI combined with 18F-FDG PET/MRI imaging was used to evaluate the efficacy of neoadjuvant therapy for gastric cancer, preoperative assessment of tumor regression grade after treatment, and re staging to guide the development of further clinical treatment plans. conditions: Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 32 type: ESTIMATED name: 18F-FAPI#18F-FDG measure: Evaluation efficacy of tumor regression level measure: expression of FAP measure: expression of GLUT1 measure: SUV sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400010 country: China name: Xiao Chen, Ph.D role: CONTACT phone: 15922970174 email: xiaochen229@foxmail.com lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06327373 id: Pro00114903 briefTitle: A Feasibility Study of Supplemental Oxygen to Improve Pulmonary Hypertension in People With Intradialytic Hypoxemia acronym: SOPHIE overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-06-30 date: 2025-06-30 date: 2024-03-25 date: 2024-03-25 name: Duke University class: OTHER briefSummary: The purpose of this study is to assess the feasibility of supplemental oxygen delivery during hemodialysis in people with pulmonary hypertension and intradialytic hypoxemia. conditions: Pulmonary Hypertension studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Oxygen name: Room air measure: Change daily hypoxemia burden measure: Change in six minute walk distance measure: Change in Montreal Cognitive Assessment (MoCA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Davita Durham East city: Durham state: North Carolina zip: 27701 country: United States lat: 35.99403 lon: -78.89862 facility: Davita Durham Downtown city: Durham state: North Carolina zip: 27703 country: United States name: Rachel Cooper role: CONTACT phone: 720-261-8901 email: rachel.cooper@davita.com lat: 35.99403 lon: -78.89862 facility: Davita Research Triangle Park city: Durham state: North Carolina zip: 27703 country: United States name: Rachel Cooper role: CONTACT phone: 720-261-8901 email: rachel.cooper@davita.com lat: 35.99403 lon: -78.89862 facility: Davita Durham Regional city: Durham state: North Carolina zip: 27704 country: United States name: Rachel Cooper role: CONTACT phone: 720-261-8901 email: rachel.cooper@davita.com lat: 35.99403 lon: -78.89862 facility: Davita Durham West city: Durham state: North Carolina zip: 27705 country: United States name: Rachel Cooper role: CONTACT phone: 720-261-8901 email: rachel.cooper@davita.com lat: 35.99403 lon: -78.89862 facility: Davita Bull City city: Durham state: North Carolina zip: 27707 country: United States name: Rachel Cooper role: CONTACT phone: 720-261-8901 email: rachel.cooper@davita.com lat: 35.99403 lon: -78.89862 facility: Davita Durham Southpoint city: Durham state: North Carolina zip: 27713 country: United States name: Rachel Cooper role: CONTACT phone: 720-261-8901 email: rachel.cooper@davita.com lat: 35.99403 lon: -78.89862 facility: Davita Hope Valley city: Durham state: North Carolina zip: 27713 country: United States name: Rachel Cooper role: CONTACT phone: 720-261-8901 email: rachel.cooper@davita.com lat: 35.99403 lon: -78.89862 facility: Davita Vance County city: Henderson state: North Carolina zip: 27536 country: United States name: Rachel Cooper role: CONTACT phone: 720-261-8901 email: rachel.cooper@davita.com lat: 36.32959 lon: -78.39916 facility: Davita Kerr Lake city: Henderson state: North Carolina zip: 27537 country: United States name: Rachel Cooper role: CONTACT phone: 720-261-8901 email: rachel.cooper@davita.com lat: 36.32959 lon: -78.39916 facility: Davita Roxboro city: Roxboro state: North Carolina zip: 27573 country: United States name: Rachel Cooper role: CONTACT phone: 720-261-8901 email: rachel.cooper@davita.com lat: 36.39375 lon: -78.98279 hasResults: False

 nctId: NCT06327360 id: FDG_ 88-16 briefTitle: Illness Expectations in Pulmonary Fibrosis acronym: CAMFP overallStatus: ENROLLING_BY_INVITATION date: 2023-10-10 date: 2023-10-10 date: 2025-10-01 date: 2024-03-25 date: 2024-04-05 name: Fondazione Don Carlo Gnocchi Onlus class: OTHER name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico name: FIMARP ONLUS - FEDERAZIONE ITALIANA IPF E MALATTIE POLMONARI RARE briefSummary: This study aims to delve into the constructs of illness beliefs and expectations among patients with Pulmonary Fibrosis, exploring how these beliefs and expectations may influence the treatment journey, including oxygen therapy, non-invasive ventilation therapy, and pharmacological treatments. conditions: Pulmonary Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 130 type: ESTIMATED name: Psychological questionnaires measure: Adherence to Pharmacological Treatment measure: Adherence to Oxygen Therapy measure: Adherence to Non invasive ventilation measure: Illness beliefs measure: Pharmacological treatment Beliefs measure: Illness Expectations measure: Illness Cognitions measure: Socio-demographic variables measure: Clinical and medical data sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano city: Milano zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 facility: Don Gnocchi Foundation city: Milano zip: 20148 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06327347 id: 2020-05_C2H briefTitle: Comparative Study of 2 Multifocal Intraocular Lenses in Heidelberg acronym: C2H overallStatus: RECRUITING date: 2022-07-17 date: 2026-03-31 date: 2026-07-31 date: 2024-03-25 date: 2024-03-25 name: Cristalens Industrie class: INDUSTRY briefSummary: The goal of this clinical trial is to compare the performance of 2 intraocular lenses (IOLs): ARTIS SYMBIOSE (study lenses) vs PANOPTIX (comparator) through binocular Distance Corrected Intermediate Visual Acuity (DCIVA) assessed at 80 cm in photopic conditions at minimum 1-month post-operative by a blinded evaluator.

This main objective will be to show superiority of the ARTIS SYMBIOSE system on the primary endpoint.

The patient population to be included is patient suffering from cataract who requires cataract surgery procedure that meet the inclusion and non-inclusion criteria and provide written informed consent.

Participants will attend a total of 5 study visits: 1 preoperative visit, 1 surgery visit and 3 postoperative visits. conditions: Cataract studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignement primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) assessed at 80 cm in photopic conditions at minimum 1-month post-operative is perforemd by a blinded evaluator. whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: intraocular lens implantation in cataract surgery measure: Binocular Distance Corrected Intermediate Visual Acuity sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC) status: RECRUITING city: Heidelberg country: Germany name: Raquel Willrich Amroussi role: CONTACT phone: +49 6221 56-36849 email: raquel.willrichamroussi@med.uni-heidelberg.de lat: 49.40768 lon: 8.69079 hasResults: False

 nctId: NCT06327334 id: 2023/03 briefTitle: Brain Heart InterActioNs in Cardiac Arrest. Ancillary Study of the HEAVENwARd Trial acronym: BHIANCA overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-05-15 date: 2027-05-15 date: 2024-03-25 date: 2024-03-25 name: CMC Ambroise Paré class: OTHER briefSummary: Despite advances in post-resuscitation care of patients with cardiac arrest (CA), the majority of survivors who are treated after restoration of spontaneous circulation (ROSC) will have sequelae of hypoxic-ischemic brain injury ranging from mild cognitive impairment to a vegetative state. Current recommendations suggest using a multimodal approach to predict poor prognosis, meaning combining markers together. Yet, a substantial proportion of patients do not have a clear prognostic evaluation even when applying the latest ESICM recommendations algorithm published in 2021. It is therefore important to identify new prognostic markers to predict both unfavorable and favorable outcomes. Data regarding the pathophysiological mechanisms of post-anoxic encephalopathy suggest a diffuse anoxo-ischemic injury. However, post-mortem neuropathology data suggest that these lesions do not uniformly affect neuroanatomical structures, with some regions (especially hippocampal and insular) appearing more sensitive to anoxia. Conversely, the brainstem appears less affected by anoxic lesions. Under physiological conditions, there are interactions between the heart and the brain, and between the brain and the heart mainly related to the autonomic nervous system, through interactions between central cortical control structures (especially insular) and brainstem structures (at the level of the bulb) and peripheral structures of the heart. Exploring the pathophysiological mechanisms of heart-brain interactions post-CA could thus help better understand the pathophysiology of anoxo-ischemic encephalopathy, before considering potential therapeutic targets. Furthermore, this heart-brain dysfunction could have prognostic value. Indeed, recent studies in healthy subjects and patients with consciousness disorders suggest that autonomic nervous system activity measured by brain-heart interactions could be a reliable marker of consciousness and cognitive processing. These coupled heart-brain interactions can be evaluated through synchronous electroencephalogram (EEG) and electrocardiogram (ECG) recordings, as there are coupled interactions between the signals of these two organs. The existence of abnormal brain-heart coupling could be associated, on the one hand, with the severity of post-anoxic encephalopathy, and on the other hand, with neurological prognosis in patients with persistent coma post-CA.

This ancillary study of a multicentre prospective cohort "HEAVENwARd study" (NCT06044922) will assess the prevalence and prognostic value of bilateral brain-heart interactions in comatose patients after CA. conditions: Cardiac Arrest studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Bilateral brain-heart interactions measure: Poor neurological outcome evaluated using the CPC score measure: Mortality measure: Post-anoxic encephalopathy severity evaluated by composite prognostic markers combining EEG patterns, somatosensory evoked potentials (SEP) and neuron specific enolase (NSE). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brest University Hospital city: Brest state: Bretagne zip: 29609 country: France name: Pierre BAILLY, MD role: CONTACT email: pierre.bailly@chu-brest.fr name: Pierre BAILLY, MD role: PRINCIPAL_INVESTIGATOR lat: 48.3903 lon: -4.48628 facility: Ambroise Paré - Hartmann Private Hospital Group city: Neuilly-sur-Seine state: Ile-de-France zip: 92200 country: France name: Guillaume GERI, MD, PhD role: CONTACT email: guillaume.geri@clinique-a-pare.fr name: Guillaume GERI, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 48.8846 lon: 2.26965 facility: Cochin Hospital city: Paris state: Ile-de-France zip: 75014 country: France name: Alain CARIOU, MD, PhD role: CONTACT email: alain.cariou@aphp.fr name: Alain CARIOU, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Nantes University Hospital city: Nantes state: Pays De La Loire zip: 44093 country: France name: Jean-Baptiste LASCARROU, MD role: CONTACT email: jeanbaptiste.lascarrou@chu-nantes.fr name: Jean-Baptiste LASCARROU, MD role: PRINCIPAL_INVESTIGATOR lat: 47.21725 lon: -1.55336 facility: Marseille University Hospital city: Marseille state: Provence-Alpes-Côte d'Azur zip: 13005 country: France name: Jeremy BOURENNE, MD role: CONTACT email: jeremy.bourenne@ap-hm.fr name: Jeremy BOURENNE, MD role: PRINCIPAL_INVESTIGATOR lat: 43.29551 lon: 5.38958 hasResults: False

 nctId: NCT06327321 id: 23-PP-08 briefTitle: Vitiligo Treatment by Targeting TYK2 Mediated Responses acronym: ViTYK overallStatus: RECRUITING date: 2024-05-05 date: 2026-05-05 date: 2026-11-05 date: 2024-03-25 date: 2024-04-12 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Vitiligo affects approximately 1 to 2% of the global population and significantly impacts people's quality of life. Achieving the best treatment outcomes for vitiligo involves addressing the autoimmune inflammatory response to stop the depigmentation process and promoting the differentiation of melanocyte stem cells to induce repigmentation. The loss of melanocytes in vitiligo is a result of an autoimmune process. While the IFN gamma pathway plays a crucial role in the adaptive immune response in vitiligo, there is increasing evidence highlighting the importance of the innate immune response. Deucravacitinib, an allosteric TYK2 inhibitor, has shown effectiveness and safety in treating psoriasis. It inhibits the responses of IFN alpha (IFNα), IFN beta (IFNβ), and IL12, and may also have an impact on the Th1 response. The hypothesis is that by targeting the IFN type I response and IL12, deucravacitinib could effectively halt the depigmentation process and facilitate repigmentation of vitiligo lesions. When combined with NB-UVB, the process of repigmentation should be significantly enhanced. The primary objective is to compare the proportion of patients treated with deucravacitinib versus placebo achieving VITIL-IA 50 at week 24.

Interventions Following central randomization, patients will be assigned to receive either deucravacitinib 12mg daily (QD) or a placebo daily (QD) for a duration of 24 weeks. At the end of this period, patients will be re-randomized to receive either deucravacitinib 12mg QD alone or deucravacitinib 12mg QD + twice weekly narrowband UVB treatment twice weekly for an additional 24 weeks.

Throughout the study, there will be a total of six visits conducted: selection, inclusion, Week 12, Week 24, Week 36, and Week 48. In patients who volunteer, a skin biopsy will be performed on both the lesional and peri-lesional areas at baseline, Week 12 and Week 36. Serum and plasma samples will be collected at the screening visit, Week 12, Week 24, Week 36, and Week 48. conditions: Vitiligo, Generalized studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 128 type: ESTIMATED name: Deucravacitinib name: Volunteer without treatment measure: rate of depigmentation measure: number of patient with the T-VASI 50 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Nice - Hôpital de l'Archet status: RECRUITING city: Nice state: Alpes-Maritimes zip: 06200 country: France name: Passeron Thierry, PhD role: CONTACT phone: +33492036488 email: passeron.t@chu-nice.fr name: pradelli Emmanuelle role: CONTACT phone: +33492036488 email: pradelli.e@chu-nice.fr name: Thierry Passeron, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 facility: APHP, Henri Mondor status: NOT_YET_RECRUITING city: Paris state: Creteil country: France name: Khaled EZZEDINE, PhD role: CONTACT email: khaled.ezzedine@aphp.fr name: Khaled EZZEDINE, PhD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: CHU de Bordeaux status: NOT_YET_RECRUITING city: Bordeaux state: Talence zip: 33000 country: France name: Julien Seneschal, PhD role: CONTACT email: julien.seneschal@chu-bordeaux.fr name: Julien Seneschal, PhD role: SUB_INVESTIGATOR lat: 44.84044 lon: -0.5805 facility: CHU de Lille status: NOT_YET_RECRUITING city: Lille country: France name: Laurent MORTIER, PhD role: CONTACT email: Laurent.MORTIER@chu-lille.fr name: Laurent MORTIER, PhD role: SUB_INVESTIGATOR lat: 50.63297 lon: 3.05858 facility: HCL status: NOT_YET_RECRUITING city: Lyon country: France name: Cécile LESORT, PhD role: CONTACT email: cecile.lesort@chu-lyon.fr name: Cécile Lesort, PhD role: SUB_INVESTIGATOR lat: 45.74848 lon: 4.84669 hasResults: False

 nctId: NCT06327308 id: 2023/803 briefTitle: Evaluation of Cirrhotic Cardiomyopathy by Cardiac MRI in Patients Waiting for Liver Transplant. acronym: CARDIOFIBROCIR overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2025-03-31 date: 2027-12-31 date: 2024-03-25 date: 2024-03-27 name: Centre Hospitalier Universitaire de Besancon class: OTHER briefSummary: The aim of this multicenter prospective observational pilot study is to describe the evolution of myocardial fibrosis in cirrhotic patients before and after liver transplantation (LT). Through multimodal analysis of myocardial function and architecture, and analysis of specific markers of inflammation, we aim to explore the following hypotheses: 1) systemic inflammation promotes myocardial fibrosis in cirrhotic patients and could be an early marker of cirrhotic cardiomyopathy; 2) LT allows resolution of myocardial fibrosis by preventing the bacterial translocation that favors the development of deleterious systemic inflammation. conditions: Cirrhosis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: MRI name: Blood sampling measure: Primary outcome measure measure: Prevalence of cirrhotic cardiomyopathy according to 2019 criteria [Izzy M, et al. Hepatology 2020;71:334-45], echocardiographic signs of left ventricular systolic and diastolic dysfunction : measure: Analysis of the association between myocardial extracellular volume (MECV) (explained variable) and plasma 3-HM concentration (explanatory variable). measure: Analysis of the association between myocardial extracellular volume (MECV) and the concentration of markers of inflammation (CRP, procalcitonin, copeptin, IL-6) and proteins modulating the degree of inflammation (LBP, PLTP, CETP). measure: Analysis of the association between the difference in MECV in transplant recipients between visit 2 and visit 3 according to the degree of immunosuppression, measured by mean residual tacrolemia in the 12 months post-LT. measure: Number, type and cumulative incidence of cardiovascular events (heart failure, rhythm disorders, etc.) according to cirrhotic cardiomyopathy status occurring between inclusion and LT. measure: Number, type and cumulative incidence of cardiovascular events (heart failure, rhythm disorders, etc.) occurring between inclusion and LT, according to cirrhotic cardiomyopathy status. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Besancon - Hopital Minjoz city: Besançon zip: 25000 country: France name: Delphine WEIL, MD, PHD role: CONTACT lat: 47.24878 lon: 6.01815 facility: CHU Dijon - Hopital François Mitterrand city: Dijon zip: 21000 country: France name: Marianne LATOURNERIE, MD role: CONTACT lat: 47.31667 lon: 5.01667 facility: CHRU Nancy - Hôpital de Brabois city: Nancy zip: 54000 country: France name: Mouni BENSENANE -OUSSALAH, MD role: CONTACT lat: 48.68439 lon: 6.18496 facility: CHU Strasbourg - Hopital de HautePierre city: Strasbourg zip: 67000 country: France name: Camille BESCH, MD role: CONTACT lat: 48.58392 lon: 7.74553 hasResults: False

 nctId: NCT06327295 id: ATB1651-102 briefTitle: A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-06-30 date: 2026-01-30 date: 2024-03-25 date: 2024-03-25 name: AmtixBio Co., Ltd. class: INDUSTRY briefSummary: The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in participants with mild to moderate onychomycosis conditions: Onychomycosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: ATB1651-102- Cohort 1 name: ATB1651-102- Cohort 2 name: ATB1651-102- Cohort 3 name: ATB1651-102- Cohort 4 name: Placebo measure: To evaluate the complete cure rate with topical ATB1651 3% and ATB1651 5% in participants with mild to moderate onychomycosis. measure: To further evaluate the efficacy of topical ATB1651 3% and topical ATB1651 5% in participants with mild to moderate onychomycosis. measure: To assess and collect the percentage and severity of adverse events (AEs). measure: Maximum plasma concentration (Cmax) measure: Time to maximum plasma concentration (Tmax) measure: Apparent terminal elimination rate constant (λz) measure: Area under curve (AUC) measure: Apparent terminal half-life (t 1/2) measure: Apparent clearance (CL) measure: Apparent terminal volume of distribution (VD) measure: Plasma ATB1651 trough concentrations (Ctrough) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: New Zealand Clinical Research Christchurch city: Christchurch zip: 8011 country: New Zealand name: Corey Sellwood, Dr role: CONTACT phone: +64 800 862 278 name: Corey Sellwood, Dr role: PRINCIPAL_INVESTIGATOR lat: -43.53333 lon: 172.63333 hasResults: False

 nctId: NCT06327282 id: ChinaPLAGHPAIN briefTitle: the Effect of Preoperative Pain Education by Anesthesia Nurses on Postoperative Pain Among Adult Patients Undergoing Abdominal Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-01-01 date: 2025-04-04 date: 2024-03-25 date: 2024-04-16 name: Chinese PLA General Hospital class: OTHER briefSummary: To explore the effects of preoperative pain education on postoperative pain among patients undergoing abdominal surgery. conditions: Postoperative Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 116 type: ESTIMATED name: education on pain and related knowledge measure: Occurrence of pain measure: Mastery of the use of patient-controlled analgesia pump measure: Patient satisfaction with postoperative analgesia measure: Adverse events of patients using analgesic pump were recorded measure: The number of times that the analgesic pump was pressed during each 24h and the amount of analgesic pump remaining at this time were recorded measure: The use of rescue analgesics after surgery measure: The postoperative sleep status of patients was evaluated sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06327269 id: MOHW111-TDU-B-221-114009 briefTitle: Innovative Diagnosis and Therapy in LDLT Patients With High-risk Hepatocellular Carcinoma overallStatus: RECRUITING date: 2021-04-01 date: 2024-12 date: 2026-12 date: 2024-03-25 date: 2024-04-18 name: Chang Gung Memorial Hospital class: OTHER name: Ministry of Health and Welfare, Taiwan briefSummary: The challenge of LDLT to HCC is that tumors with a high risk of recurrence have a high rate of recurrence after liver transplantation, and there is no appropriate treatment to prevent HCC recurrence after transplantation in these patients. Using the advance proton therapy or yttrium 90 as a more aggressive down-staging therapy may contribute to change tumor behavior. It can be used to get a better treatment response and tumor necrosis before LDLT. As a result, it will improve recurrence-free survival and overall survival rate, especially in high-risk groups. In addition, lenvatinib is approved for using in patients with advanced liver cancer because its overall survival rate is not less than sorafenib in clinical trials. A new generation of targeted therapies will be applied to adjuvant therapy after LDLT. conditions: High Risk of Recurrence studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: Lenvatinib 10 mg measure: Recurrence-free survival with adjuvant therapy sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Surgery status: RECRUITING city: Kaohsiung zip: 833 country: Taiwan name: Chih-Che Lin, Ph.D role: CONTACT phone: +88677317123 phoneExt: 8880 email: chihchelin@cgmh.org.tw name: I-Hsuan Chen, Ph.D role: CONTACT phone: +88677317123 phoneExt: 8582 email: ann0401@cgmh.org.tw lat: 22.61626 lon: 120.31333 hasResults: False

 nctId: NCT06327256 id: 1509-0002 id: 2023-509293-29-00 type: REGISTRY domain: CTIS id: U1111-1299-6907 type: REGISTRY domain: WHO International Clinical Trials Registry Platform (ICTRP) briefTitle: A Study in Healthy People to Test How Well Different Doses of BI 3000202 Are Tolerated and How They Affect the Way the Body Handles Midazolam overallStatus: RECRUITING date: 2024-03-28 date: 2024-09-27 date: 2024-09-27 date: 2024-03-25 date: 2024-04-12 name: Boehringer Ingelheim class: INDUSTRY briefSummary: The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) following multiple rising doses of BI 3000202 and to investigate the effect of BI 3000202 on the metabolism of midazolam. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The multiple rising dose part of the trial will be conducted in a parallel group assignment. The effect of midazolam interaction will be assessed sequentially. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The multiple rising dose part of the trial will be blinded to the participants and investigators . The effect of midazolam will be assessed open label. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: BI 3000202 name: Placebo name: Midazolam measure: Percentage of subjects with drug-related adverse events measure: Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 12 hours (AUC0-12) measure: Maximum measured concentration BI 3000202 in plasma (Cmax) measure: Area under the concentration-time curve of BI 3000202 in plasma over a uniform dosing interval τ (AUCτ,ss) at steady state measure: Maximum measured concentration of BI 3000202 in plasma (Cmax,ss) at steady state measure: Time from dosing to the maximum measured concentration of BI 3000202 in plasma (tmax,ss) at steady state measure: Area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) after a single dose measure: Maximum measured concentration of midazolam in plasma (Cmax) after a single dose sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: SGS Life Science Services - Clinical Research status: RECRUITING city: Edegem zip: 2650 country: Belgium name: Boehringer Ingelheim role: CONTACT phone: 080049616 email: belgique@bitrialsupport.com lat: 51.15662 lon: 4.44504 hasResults: False

 nctId: NCT06327243 id: TUMRHS briefTitle: The Effects of Kinesio Taping on Pain, Range of Motion, and Functional Performance in People With Knee Osteoarthritis overallStatus: RECRUITING date: 2024-03-01 date: 2024-04-01 date: 2024-04-30 date: 2024-03-25 date: 2024-03-25 name: Taibah University class: OTHER briefSummary: The goal of this clinical trial is to evaluate the effectiveness of Kinesio Taping in individuals with knee osteoarthritis (KOA). KOA is a common condition that can lead to pain, stiffness, and decreased mobility. The main questions it aims to answer are:

* Does Kinesio Taping reduce pain in individuals with KOA?
* Can Kinesio Taping improve the range of motion and functional performance in those suffering from KOA?

Participants will be asked to:

Attend assessment sessions at the outpatient Physical Therapy clinic at Taibah University.

Undergo Kinesio Taping three times over 12 days. Complete specific physical tests and questionnaires before and after the intervention period to measure their pain and mobility.

Researchers will compare the group that receives Kinesio Taping with the group that receives sham (placebo) taping to see if there are significant differences in pain reduction and improvements in movement and daily function. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In a randomized and single-blinded approach, participants are divided into two groups. One group receives actual Kinesio taping, while the other undergoes a sham procedure, with neither group aware of their specific treatment type to ensure unbiased results. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants will not know if they are receiving the actual Kinesio Taping (KT) treatment or a sham taping. The KT will be applied following the correct standards for the rectus femoris muscle, including appropriate stretching. Conversely, the placebo taping will be applied horizontally across the muscle fibers without any stretching. The therapists applying the tape will know which treatment each participant is allocated to ensure that the application of either the real KT or the placebo taping aligns with the study's protocol. whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Elastic tape ( kinesio tape) name: Sham Taping measure: Pain (Visual analog scale) measure: Knee range of motion measure: Timed up and go test measure: The 50-foot Walk measure: Knee Osteoarthritis Outcome Score (KOOS) sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taibah University status: RECRUITING city: Medina zip: 42353 country: Saudi Arabia name: President of the university role: CONTACT email: tawasul@taibahu.edu.sa name: Marwan MA Aljohani, Phd role: CONTACT email: mmjohani@taibahu.edu.sa lat: 24.46861 lon: 39.61417 hasResults: False

 nctId: NCT06327230 id: SRRSH2023-0627 briefTitle: The Application of Thoracic Epidural Analgesia in Patients With Acute Pancreatitis overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2026-04-30 date: 2024-03-25 date: 2024-03-25 name: Sir Run Run Shaw Hospital class: OTHER briefSummary: Acute pancreatitis (AP) is one of the most common diseases of the digestive system, with its incidence increasing year by year. 15%-25% of patients will develop severe acute pancreatitis (SAP), characterized by necrosis and infection of the pancreas and surrounding tissues, as the investigators as multiple organ dysfunction syndrome (MODS), with a mortality rate as high as 17%. Currently, there is a lack of effective measures in clinical practice to regulate the early inflammation and immune response in acute pancreatitis. Animal experimental studies have confirmed that TEA, by blocking the abdominal sympathetic nerves, increases arterial blood flow and venous capacity, improves pancreatic perfusion insufficiency caused by AP, and alleviates metabolic acidosis. Simultaneously, TEA can suppress the secretion of catecholamines during the stress state of acute pancreatitis, reducing the release of inflammatory mediators and thereby inhibiting the inflammatory response. Our team's earlier animal experiments have further confirmed that TEA improves intestinal inflammation in mice with pancreatitis. This improvement is marked by a significant reduction in the concentrations of inflammatory cytokines such as IL-1β and TNF-α. Additionally, there is an observed alteration in the intestinal microbiota, characterized by an increase in the proportion of beneficial bacteria. Based on these findings, it is speculated that TEA, by reducing catecholamine release and downregulating sympathetic activity, effectively mitigates inflammation and stress responses in patients with pancreatitis. Furthermore, TEA dilates small arteries in blocked segments, thereby improving blood flow and microcirculation within the affected area. Indirectly, TEA increases vagal nerve activity, which in turn slows down the progression of intestinal ischemia, consequently reducing the impact of the "second hit" caused by the translocation of intestinal bacteria and endotoxins into the bloodstream, which exacerbates acute pancreatitis. Despite these promising results, clinical data on the efficacy of TEA in acute pancreatitis remains insufficient. Moreover, the precise mechanisms by which TEA influences the progression and severity of acute pancreatitis are yet to be fully elucidated. In order to further validate the clinical therapeutic effects of TEA and gain a deeper understanding of its mechanisms, the investigators have conducted this clinical study. conditions: Acute Pancreatitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 88 type: ESTIMATED name: Thoracic Epidural Analgesia measure: The change in systemic inflammatory response syndrome (SIRS) and organ dysfunction after inclusion. measure: The change in intra-abdominal pressure (measured via bladder pressure) after treatment. measure: The change in resting pain and movement pain after inclusion. measure: Peripheral blood inflammation and immune markers. measure: intestinal microbiota measure: total ICU treatment time measure: adverse event occurrence rate sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sir Run Run Shaw Hospital city: Hangzhou state: Zhejiang zip: 310016 country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06327217 id: OC-2023-009 briefTitle: Long Term Results After Hip Arthroscopy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-01 date: 2025-03-01 date: 2024-03-25 date: 2024-03-25 name: Reinier Haga Orthopedisch Centrum class: OTHER briefSummary: A common cause of hip joint pain in the young and active population is femoroacetabular impingement (FAI) syndrome. if FAI is left untreated, the changed morphology will have a negative effect on the existing joint and will contribute to the development of osteoarthritis (OA). Hip arthroscopy is the first choice of operative treatment for FAI. While hip arthroscopy improves the patient reported outcome measures (PROMs), the influence of this treatment on the contribution to the development of osteoarthritis after FAI is to the best of our knowledge still unknown. conditions: Femoro Acetabular Impingement studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 451 type: ESTIMATED name: Bilateral hip x-ray name: Questionnaires measure: To evaluate the degree of osteoarthritis 5 to 10 years after a hip arthroscopy in comparison with the non-operative side. measure: To evaluate the change in degree of osteoarthritis at 5 to 10 years after a hip arthroscopy in comparison with preoperative/perioperative. measure: To report incidence of total hip replacement within 5 to 10 years after a hip arthroscopy. measure: To determine the functional outcome of patients and, to determine what factors contribute to a good functional outcome 5/10 years after hip arthroscopy. measure: To determine the inter-rater and intra-rater agreement of the Kellgren and Lawrence OA score. measure: To determine patient satisfaction 5-10 years after hip arthroscopy. sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Reinier Haga Orthopedic Center city: Zoetermeer zip: 2725 NA country: Netherlands lat: 52.0575 lon: 4.49306 hasResults: False

 nctId: NCT06327204 id: Low Level laser 24 briefTitle: Efficacy of Different Low Level Laser Therapy Sessions overallStatus: COMPLETED date: 2023-03-01 date: 2023-10-01 date: 2023-12-01 date: 2024-03-25 date: 2024-03-25 name: October 6 University class: OTHER briefSummary: Myofascial pain dysfunction syndrome is one of the common causes of non-odontogenic pain in the head and neck region. It accounts for 40-60% of the adult population. Different treatment modalities had been reported to release the trigger point within the muscles of mastication in order to reduce pain and allow recovery of the function. conditions: Myofascial Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 90 type: ACTUAL name: 940-nm diode laser / one session name: 940-nm diode laser / two session name: 940-nm diode laser/ three session measure: pain score measure: maximum mouth opening measure: quality of life questioner sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Dentistry, October 6 University city: Cairo zip: 21523 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06327191 id: 23-CRFG-21 id: 23-CRFG-21 type: OTHER domain: Clinical Research Facility Galway (CRFG) study number briefTitle: EMERGE Mothers and Kids overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2025-12 date: 2024-03-25 date: 2024-03-25 name: National University of Ireland, Galway, Ireland class: OTHER briefSummary: The EMERGE Mothers and Kids study is a follow-up to the EMERGE trial of women with GDM (N=535) that aimed to determine the effect of the addition of metformin compared to placebo on insulin initiation rates, maternal weight gain and perinatal morbidity and mortality.

The primary objectives of the EMERGE Mothers and Kids follow up study are:

1. to determine whether treatment with metformin leads to a reduction in maternal disorders of glucose, metabolic syndrome, obesity, hypertension and lipids at up to 6 years post the index pregnancy;
2. to examine the impact of metformin on maternal anxiety, depression, quality of life and breast feeding duration;
3. to examine whether exposure to metformin leads to a reduction in obesity in the offspring at follow up;
4. to determine whether treatment with metformin during pregnancy, in women with GDM, leads to a reduction in adiposity in the offspring at follow up as measured by anthropometric measurements and sum of skinfolds. conditions: Gestational Diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 321 type: ESTIMATED name: No intervention as the study is observational. measure: To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of disorders of glucose metabolism at follow up.. measure: To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of metabolic syndrome. measure: To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces rates of OW and OB at follow up. measure: To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of hypertension. measure: To examine the associations of GDM diagnosis, sum of fasting, 1-hour, and 2-hour glucose z-scores after 75-g load, insulin sensitivity, and lipid levels at 24-32 weeks' gestation with lipid levels 3-6 years postpartum. measure: To determine whether treatment with metformin during pregnancy, in women with GDM, leads to a reduction in adiposity in the offspring at follow up as measured by anthropometric measurements and sum of skinfolds. sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06327178 id: NFEC-2023-520 briefTitle: Abscopal Effects of Stereotactic Body Radiotherapy in Metastatic Clear Renal Cell Carcinoma overallStatus: RECRUITING date: 2023-10-01 date: 2024-01-31 date: 2024-04-30 date: 2024-03-25 date: 2024-03-26 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: Prior research has indicated that stereotactic body radiotherapy (SBRT) can effectively trigger systemic anti-tumor immune response. The goal of this observational study is to learn about abscopal effects of stereotactic body radiotherapy in patients of metastatic clear renal cell carcinoma. The primary objective was to assess the objective response rate (ORR) and complete response (CR) in non-irradiated lesions, and incidence of adverse events (AEs). conditions: Abscopal Effects of Stereotactic Body Radiotherapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 20 type: ESTIMATED measure: Objective Response Rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanfang Hospital, Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong zip: 510515 country: China name: Guozhu Xie role: CONTACT email: xieguozhu@126.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06327165 id: 1-2023-0072 briefTitle: Predictability of ANI (Analgesia Nociception Index) for Spinal Hypotension overallStatus: RECRUITING date: 2024-03-18 date: 2024-12-31 date: 2024-12-31 date: 2024-03-25 date: 2024-03-27 name: Yonsei University class: OTHER briefSummary: Spinal anesthesia is widely accepted as the anesthetic method of choice for Cesarean section. However, the incidence of spinal hypotension is 50-70%, and the decrease in blood pressure is often rapid and severe. Heart rate variability is influenced by various factors such as the sympathetic nervous system, parasympathetic nervous system, temperature regulation, baroreflex, and endocrine regulation, but high frequency heart rate variability above 0.15 Hz very specifically reflects the parasympathetic nervous system. The ANI monitor calculates heart rate variability mediated by changes in the parasympathetic nervous system. This study aims to determine whether ANI monitor can predict hypotension in patients undergoing a caesarean section under spinal anaesthesia while applying the preemptive vasopressor phenylephrine infusion protocol. conditions: Cesarean Section conditions: Spinal Anesthesia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: observation measure: predictive value of ANI monitor for spinal hypotension during cesarean delivery measure: Optimal cutoff value of ANI level for predicting occurrence of hypotension sex: FEMALE minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yonsei University Health system, Severance Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Seung Hyun Kim, Associate Professor role: CONTACT phone: 82-2-2224-1055 email: anesshkim@yuhs.ac lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06327152 id: 2659 briefTitle: Caffeine Use in the Management of Preterm Infants overallStatus: RECRUITING date: 2024-02-22 date: 2026-12-31 date: 2026-12-31 date: 2024-03-25 date: 2024-03-26 name: University of California, Irvine class: OTHER briefSummary: This study aims to assess whether extending the duration of caffeine therapy will help preterm infants achieve full oral feeding faster. conditions: Apnea of Prematurity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomized, double-blinded, placebo-controlled trial of 40 preterm infants born at less than or equal to 32 weeks and 0 days gestation. Infants will be randomized to receive either caffeine or placebo for up to maximum of additional four (4) weeks after meeting clinical criteria to come off caffeine. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Families, nurses, therapists, and doctors will be blinded. Only pharmacy will be unblinded and know which subjects are in each treatment arm. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Caffeine name: Sterile Water Placebo measure: Time to full feeds measure: Time to discharge measure: Post menstrual age (PMA) at time of discharge measure: Number of significant cardiopulmonary events measure: Weight change sex: ALL minimumAge: 1 Day maximumAge: 40 Weeks stdAges: CHILD facility: UC Irvine Medical Center status: RECRUITING city: Orange state: California zip: 92868 country: United States name: Cherry Uy, MD role: CONTACT phone: 714-456-6933 email: ccuy@hs.uci.edu name: Cherry Uy, MD role: PRINCIPAL_INVESTIGATOR name: Ernest Lai, MD role: SUB_INVESTIGATOR name: Muhammad Aslam, MD role: SUB_INVESTIGATOR lat: 33.78779 lon: -117.85311 hasResults: False

 nctId: NCT06327139 id: CTRIAL 23-24 briefTitle: Optimising Patient Experience in Head and Neck Radiotherapy acronym: OPEN overallStatus: RECRUITING date: 2024-01-02 date: 2025-05 date: 2025-07 date: 2024-03-25 date: 2024-03-25 name: Irish Research Radiation Oncology Group class: NETWORK briefSummary: This study is a phase III, randomized, single-centre, multiple arm trial examining the set-up accuracy of three different types of immobilization methods for head and neck cancer patients receiving radical radiation therapy. The methods of immobilization under investigation in this study are two types of open faced head and neck masks compared with the convention closed faced head and neck mask. Patients receiving treatment using an open faced mask will have their intra fraction motion monitored through the use of intra fraction surface guided monitoring. The study aims to determine the set-up accuracy of the three types of immobilization through measuring the magnitude of the translational corrections on the daily cone beam computed tomography (CBCT). To be eligible for the study a patient must be planned to receive a minimum of 30 fractions of head and neck radiation therapy.

Patients distress levels associated with each type of immobilization device will be measured using the psychological measure General Health Questionnaire-12 (GHQ-12) which will be collected at the beginning and end of their course of radiation therapy treatment. conditions: Head and Neck Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a phase III, randomized, single-centre, multiple arm trial of immobilization methods for head and neck cancer patients receiving radical radiation therapy. A faceless three point head and neck mask in conjunction with intra fraction surface guided monitoring, a faceless five point mask in conjunction with intra fraction surface guided monitoring and a conventional closed face five point mask without the use of intra fraction surface guided monitoring are being investigated in this study. The set-up accuracy will be based on the magnitude of the translational corrections measured prior to delivery of each radiation therapy fraction. primaryPurpose: TREATMENT masking: NONE count: 201 type: ESTIMATED name: Conventional 5 point closed face immobilisation mask. name: 5 point open face immobilization mask name: 3 point open face immobilization mask measure: The setup accuracy of each immobilization device will be measured based on the magnitude of the translational corrections measured in millimeters prior to delivery of each radiation therapy fraction. measure: Estimate of distress levels during the first week and during the final week of the participants course of radiation therapy using the psychological measure General Health Questionnaire-12 (GHQ-12). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Luke's Radiation Oncology Network status: RECRUITING city: Dublin zip: D06 HH36 country: Ireland name: Roisin O Maolalai, BSc role: CONTACT phone: 0035314065458 email: Roisin.OMaolalai@slh.ie name: Emma Noone, BSc MA role: CONTACT phone: 003534065467 email: Emma.Noone@slh.ie name: Sinead Brennan, FFR RCSI role: PRINCIPAL_INVESTIGATOR lat: 53.33306 lon: -6.24889 hasResults: False

 nctId: NCT06327126 id: BFHHZS20240001 briefTitle: Efficacy and Safety of Single-session Endoscopic Stone Extraction overallStatus: RECRUITING date: 2024-01-01 date: 2024-05-01 date: 2024-05-01 date: 2024-03-25 date: 2024-04-18 name: Beijing Friendship Hospital class: OTHER briefSummary: This is a retrospective study, including approximately 600 patients with acute cholangitis accompanied with choledocholithiasis, who treated with single-session or two-session endoscopic stone extraction at Beijing friendship hospital. The investigators assessed the outcomes of single-stage and two-stage endoscopic stone extraction. conditions: Choledocholithiasis With Acute Cholangitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 600 type: ESTIMATED name: two-session ERCP name: single-session ERCP measure: Success rate of complete stone removal measure: ERCP-related complication rate measure: Length of stay measure: Hospital expenses sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Friendship Hospital status: RECRUITING city: Beijing state: Beijing zip: 100050 country: China name: Wei Jiang role: CONTACT phone: 18663186116 email: jfw899w@outlook.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06327113 id: IRB#23-001248 briefTitle: Antibiotic Tumescent For Chronic Wounds acronym: TAI overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2027-03-25 date: 2028-03-25 date: 2024-03-25 date: 2024-03-25 name: University of California, Los Angeles class: OTHER briefSummary: Chronic non-healing wounds are becoming an increasingly more common problem. Eligible, consenting patients with chronic leg wounds will either continue to the standard of care or will be randomized to the treatment cohort where antibiotic solution will be injected in the area around the wound. All patients will continue standard wound care as dictated by the wound care clinic. Subjects of both the control and treatment will have approximately 6 study specific visits that may or may not coincide with previously schedule wound care clinic visits. As these specified visits wound size and healing will be documented and patients will complete surveys. The study will conclude for the subject after approximately 6 months. Again, these patients may continue standard wound care but will no longer have study obligations. conditions: Non-healing Wound studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a single center, prospective, comparative interventional, two-arm parallel group, randomized, clinical safety and efficacy trial comparing a group receiving standard wound care with tumescent antibiotic injection (TAI) with a control group receiving standard wound care primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: CeFAZolin Injectable Solution measure: Primary Objective - Assess the rate of occurrence and severity of adverse events and their relationship to TAI measure: Secondary Objective - To evaluate wound size and closure. measure: Secondary Objective - Chronic-wound-related pain measure: Secondary Objective - Rating Quality of life measure: Exploratory Objectives - Assess the number of chronic wound-related complications (increased wound sizes, infections, dermatitis). measure: Exploratory Objectives - Assess the number of clinical signs of infection in participants. measure: Exploratory Objectives - Determine the species of pathogenic bacteria present in wound. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06327100 id: 2023-0934 id: NCI-2024-02551 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Open Label Phase 2 Study of Tasquinimod in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF) overallStatus: NOT_YET_RECRUITING date: 2024-09-30 date: 2029-05-01 date: 2031-05-01 date: 2024-03-25 date: 2024-04-29 name: M.D. Anderson Cancer Center class: OTHER name: Active Biotech AB briefSummary: To learn if tasquinimod either alone or in combination with ruxolitinib can help to control PMF, post-PV MF, or post-ET MF. conditions: Primary Myelofibrosis conditions: Post-polycythemia Vera Myelofibrosis conditions: Post-Essential Thrombocytosis Myelofibrosis studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: Ruxolitinib name: Tasquinimod measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Lucia Masarova, MD role: CONTACT phone: 832-750-4211 email: lmasarova@mdanderson.org name: Lucia Masarova, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06327087 id: 22-00874 briefTitle: Appetite and Dietary Intake Across the Menstrual Cycle overallStatus: RECRUITING date: 2022-06-01 date: 2025-05-31 date: 2025-05-31 date: 2024-03-25 date: 2024-04-04 name: University of British Columbia class: OTHER briefSummary: Lay language summary: Women are younger and menstruating about monthly ("pre-menopausal") often have fluctuations in the food they eat ("dietary intake") across the menstrual cycle. However, relationships between food intake and appetite, metabolism, body composition (i.e., the proportion of muscle and fat), physical activity and premenstrual symptoms have not been reported. This study will measure appetite and food intake in laboratory and usual life settings in healthy pre-menopausal women in two hormonally different parts of the menstrual cycle. Data on ovarian hormones, metabolism, body composition, physical activity and premenstrual symptoms will also be collected to assess their potential relationship with food intake. conditions: Appetitive Behavior conditions: Healthy conditions: Dietary Habits studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 23 type: ESTIMATED name: No intervention measure: Energy intake measure: Hunger area under the curve measure: Satiety area under the curve measure: Prospective food consumption area under the curve measure: Free-living ad libitum energy intake measure: Resting metabolic rate measure: Body composition measure: Estradiol measure: Progesterone measure: Physical activity patterns sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: University of British Columbia - Okanagan status: RECRUITING city: Kelowna state: British Columbia zip: V1V1V7 country: Canada name: Sarah Purcell, PhD role: CONTACT phone: 2508079827 email: sarah.purcell@ubc.ca lat: 49.88307 lon: -119.48568 hasResults: False

 nctId: NCT06327074 id: 21-3063.cc briefTitle: Testing the Engaged Approach to Lung Cancer Screening overallStatus: RECRUITING date: 2024-03-11 date: 2025-12 date: 2026-12 date: 2024-03-25 date: 2024-03-25 name: University of Colorado, Denver class: OTHER name: Bristol-Myers Squibb briefSummary: The goal of this study is to assess feasibility and acceptability of the Engaged Approach to Lung Cancer Screening (EA-LCS) in diverse lung cancer screening (LCS) programs operating in a variety of geographic regions across Colorado and the US. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 40 type: ESTIMATED name: Engaged Approach to Lung Cancer Screening measure: Percentage of the intervention group who would like to continue the EA-LCS framework measure: Percentage of the intervention group who would recommend the EA-LCS framework to other programs measure: Percentage of participants who would describe the framework as workable measure: Evaluate the intervention acceptability by Acceptability of Intervention Measure (AIM) measure: Evaluate the intervention appropriateness by Intervention Appropriateness Measure (IAM) measure: Evaluate the intervention feasibility by Feasibility of Intervention Measure (FIM) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Hospital status: RECRUITING city: Denver state: Colorado zip: 80045 country: United States name: Jamie Studts role: CONTACT email: Jamie.Studts@CUANSCHUTZ.EDU name: Jamie Studts, PhD role: PRINCIPAL_INVESTIGATOR name: Erin Hirsch role: SUB_INVESTIGATOR lat: 39.73915 lon: -104.9847 hasResults: False

 nctId: NCT06327061 id: R01DA058659 type: NIH link: https://reporter.nih.gov/quickSearch/R01DA058659 id: IRB00026607 type: OTHER domain: JHSPH IRB briefTitle: Social Network Overdose Prevention and Education Intervention overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-06-01 date: 2027-12-01 date: 2024-03-25 date: 2024-04-16 name: Johns Hopkins Bloomberg School of Public Health class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: The purpose of this study is to test a social intervention focused on overdose prevention and care. In the investigators prior work, the investigators have shown that people who use opioids (PWUO) can be effective peer educators (PEs). conditions: Drug Overdose studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a standard two-group clinical trial, one group is the experimental, the other the control primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Both groups receive overdose prevention training whoMasked: PARTICIPANT count: 600 type: ESTIMATED name: Network overdose prevention name: Standard of care health education measure: Number of drug overdoses measure: Participant drug use measure: Number of Network member contacts sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins Bloomberg School of Public Health city: Baltimore state: Maryland zip: 21205 country: United States lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06327048 id: School of Nursing briefTitle: Application of Cognitive Training Based on Remind Strategy in Glioma Patients With Cognitive Impairment overallStatus: RECRUITING date: 2024-03-06 date: 2024-11-30 date: 2024-12-01 date: 2024-03-25 date: 2024-03-25 name: YuanYuan Ma class: OTHER briefSummary: The purpose of this study is to form an interdisciplinary team to dynamically evaluate patient cognitive outcomes and develop an individualized cognitive training program for Chinese brain tumor patients conditions: Glioma studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Non-randomized intervention study primaryPurpose: OTHER masking: SINGLE maskingDescription: Blind the evaluator whoMasked: OUTCOMES_ASSESSOR count: 72 type: ESTIMATED name: Individual cognitive rehabilitation training based on Remind strategy was given measure: Montreal Cognitive Assessment(MoCA) measure: The European Organization for Research and Treatment of Cancer core Quality of Life Questionnaire (EORTC QLQ-C30) measure: The EORTC QLQ-Brain Neoplasms 20(EORTC QLQ-BN20) measure: Self-Rating Anxiety Scale(SAS) measure: Self-Rating Depression Scale(SDS) measure: Modified Barthel Index(MBI) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yuanyuanma status: RECRUITING city: Lanzhou state: Gansu country: China name: yuanyuan ma, Bachelor role: CONTACT phone: 15294126094 email: 1657107645@qq.com lat: 36.05701 lon: 103.83987 hasResults: False

 nctId: NCT06327035 id: 2023-A02660-45 briefTitle: Evolution of Walking Abilities in Subacute Stroke Patients Hospitalized in Neurorehabilitation Center acronym: PROWALK overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2025-04-01 date: 2025-04-01 date: 2024-03-25 date: 2024-03-25 name: Clinique Les Trois Soleils class: OTHER name: Le Normandy briefSummary: The goal of this observational study is to describe the evolution of gait recovery during the subacute phase of stroke up to six months after stroke, in patients hospitalized in medical and neurological rehabilitation units. conditions: Stroke conditions: Gait, Hemiplegic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Gait rehabilitation measure: Functional Ambulation Classification measure: Postural Assesment Scale for Stroke Patient measure: Timed Up and Go measure: 10-Meter Walk Test measure: 6Minute-Walk Test measure: Motricity Index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06327022 id: P0038444 briefTitle: Social Media-based Electronic Bibliotherapy for Dementia Caregivers overallStatus: COMPLETED date: 2022-07-01 date: 2023-12-31 date: 2023-12-31 date: 2024-03-25 date: 2024-03-25 name: The Hong Kong Polytechnic University class: OTHER briefSummary: This study aims to assess the efficacy of social media-based electronic bibliotherapy in improving the well-being of informal caregivers of people with dementia compared to a control group. conditions: Mental Health conditions: Quality of Life conditions: Dementia Caregivers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Social media-based electronic bibliotherapy name: Usual care measure: Changes in mental health measure: Changes in health related quality of life measure: Changes in caregiving appraisal measure: Changes in psychological wellbeing sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Hong Kong Polytechnic University city: Kowloon country: Hong Kong lat: 22.31667 lon: 114.18333 hasResults: False

 nctId: NCT06327009 id: fasting ramadan in GN patients briefTitle: Effect of Ramadan Fasting on Kidney Function and Proteinuria in Patients With Glomerulonephritis overallStatus: NOT_YET_RECRUITING date: 2024-03-22 date: 2024-04-22 date: 2024-05-22 date: 2024-03-25 date: 2024-03-25 name: Alexandria University class: OTHER briefSummary: This research aims to assess effects of ramadan fasting on kidney function and proteinuria in patients with glomerulonephritis. conditions: Fasting Ramadan studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: fasting month of ramadan measure: Change in kidney function measure: Change in proteinuria sex: ALL minimumAge: 18 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine, Aexandria University city: Alexandria zip: 21526 country: Egypt name: Mohamed Mamdouh Elsayed, MD role: CONTACT email: dr_mohamedmamdouh87@yahoo.com lat: 31.21564 lon: 29.95527 hasResults: False

 nctId: NCT06326996 id: 23-001185 briefTitle: Thiamine Intervention and Coronary Artery Bypass Grafting acronym: B1&CABG overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-01 date: 2026-05 date: 2024-03-25 date: 2024-04-01 name: University of California, Los Angeles class: OTHER briefSummary: The purpose of this study is to gain a better understanding of the association between brain changes and cognitive deficits in coronary heart disease (CHD) patients undergoing coronary artery bypass grafting (CABG) and whether a low-cost thiamine intervention can be used to reduce post-CABG cognitive issues in CHD subjects. conditions: Coronary Heart Disease conditions: Coronary Artery Bypass Grafting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Post-CABG patients with and without thiamine treatment. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants will be assigned a random number, double-blind randomized, \& longitudinal study design. whoMasked: PARTICIPANT count: 52 type: ESTIMATED name: Thiamine name: Placebo measure: Effects of thiamine treatment intervention on blood lactate levels. measure: Effects of thiamine treatment intervention on blood thiamine levels. measure: Effects of thiamine treatment intervention on blood inflammatory levels. measure: Evaluate cognitive function in CABG patients with thiamine treatment. measure: Evaluate long term effects of thiamine treatment intervention on cognitive function in CABG patients with thiamine treatment. measure: Examine cognition in CABG patients with thiamine treatment. measure: Examine long term effects of thiamine treatment intervention on cognition in CABG patients with thiamine treatment. measure: Cognition assessment in CABG patients after thiamine treatment. measure: Assessment of long term effects of thiamine treatment intervention on cognition in CABG patients after thiamine treatment. measure: Long term effect of thiamine treatment intervention on quality of life. measure: Long term effect of thiamine treatment intervention on daily activities using PASE. measure: Long term effect of thiamine treatment intervention on daily activities using PPA. sex: ALL minimumAge: 60 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCLA city: Los Angeles state: California zip: 90095 country: United States lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06326983 id: IRB-P00047028 briefTitle: Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2026-04-01 date: 2024-03-25 date: 2024-03-25 name: Boston Children's Hospital class: OTHER briefSummary: This is a prospective, randomized, controlled, non-inferiority study of patients undergoing tonsil surgeries at Boston Children's Hospital Waltham. The overall aim is to evaluate the efficacy of an opioid anesthetic plan (morphine, ketorolac, and acetaminophen versus an opioid sparing anesthetic plan (dexmedetomidine, ketorolac and acetaminophen) for perioperative analgesia and recovery time in patients undergoing tonsillectomies and tonsillotomies at Boston Children's Hospital Waltham. Secondary measures include rescue opioids administered in post-anesthesia care unit (PACU), re-operation secondary to bleeding, emergence delirium, post-operative nausea and vomiting, intraoperative hemodynamics, intraoperative vasopressor administration, and length of procedure. conditions: Tonsillitis conditions: Post-operative Nausea and Vomiting (PONV) conditions: Emergence Delirium conditions: Opioid Analgesic Adverse Reaction conditions: Anesthesia conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 58 type: ESTIMATED name: Dexmedetomidine name: Acetaminophen name: Ketorolac name: Morphine measure: Median Pain Scores in the Post-Anesthesia Care Unit measure: Post-operative pain at 12-24 hours measure: Post Operative Anesthesia Unit Length of Stay (hours) measure: Opioid rescue medication administration measure: Emergence Delirium measure: Post-operative nausea and vomiting measure: Procedure length (minutes) measure: Intraoperative Blood pressure (mmHg) measure: Intraoperative Heart rate (beats per second) measure: Vasopressor administration sex: ALL minimumAge: 3 Years maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06326970 id: HenanICE202401 briefTitle: SPECT Fibroblast Activation Protein Imaging in Patients With Cardiac Disease overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-03-22 date: 2024-03-22 name: Henan Institute of Cardiovascular Epidemiology class: OTHER briefSummary: This observational study aims to learn about the preliminary exploration of 99mTc-FAPI imaging in heart diseases and its potential application.

Participant involves patients with myocarditis, pulmonary hypertension, arrhythmia, myocardial infarction, dilated cardiomyopathy, and cardiac tumors, health conditions may also studied as control.

The main questions it aims to answer are 1, radionuclide 99mTc labeled fibroblast-activated protein inhibitors (99mTc-FAPI) imaging in the use of cardiac diseases and its limitations. 2, the performance in subjects with different control of hypertension to evaluate myocardial injury and fibrosis for providing a molecular biological basis for the study of diseases and mechanisms.

Participants will undergo 99mTc-FAPI imaging by Single-photon emission computed tomography (SPECT) and record their cardiac disease characterization and treatment. conditions: Myocardial Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: 99mTc-FAPI SPECT imaging measure: positive uptake sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06326957 id: 334979 V1 15/01/2024 id: NIHR302904 type: OTHER_GRANT domain: National Institute for Health & Care Research (NIHR) id: 24/LO/0142 type: OTHER domain: Research Ethics Committee (REC) briefTitle: Reducing Chronic Breathlessness in Adults by Following a Self-guided, Internet Based Supportive Intervention (SELF-BREATHE) acronym: SELF-BREATHE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-02 date: 2028-07 date: 2024-03-22 date: 2024-03-25 name: King's College Hospital NHS Trust class: OTHER briefSummary: Background:

Some health conditions make breathing difficult and uncomfortable. When this happens every day, it is called chronic breathlessness. Over 3 million people living with heart and lung disease have chronic breathlessness in the UK.

Breathlessness is very difficult for patients themselves and their families, resulting in disability and feelings of fear, distress, and isolation. Due a to lack of supportive breathlessness services many patients frequently attend hospital Accident and Emergency (A\&E) departments seeking help.

Given the on-going challenges faced by the National Health Service (NHS) in the United Kingdom, such as long waiting times, staff shortages, increased demand for services because of the COVID-19 pandemic, there is an urgent need to develop new ways to support those living with chronic breathlessness. One potential solution is to offer support online, as it is estimated that in the UK, 7 out of every 10 people with chronic breathlessness are internet users.

With the help of patients and NIHR funding the research team lead by Dr Charles Reilly, developed an online breathlessness supportive website called SELF-BREATHE. SELF-BREATHE provides information and self-management tools such as breathing exercises, that patients can do at home themselves.

SELF-BREATHE has been tested as part of its development. SELF-BREATHE is acceptable and valued by patients. But what is unknown is whether SELF-BREATHE improves patients' breathlessness and their life? This is the question this research seeks to answer.

Aims

1. To test if using SELF-BREATHE for six-weeks improves patients' breathlessness, their quality of life and whether SELF-BREATHE should be offered within the NHS
2. To see if patients opt to continue to use SELF-BREATHE after six-weeks and what benefits this may have for patients.

Methods

The research team are undertaking a randomised controlled trial. For this, 246 people living with chronic breathlessness will be recruited in to this study. Each person will be randomly chosen by a computer to continue with their usual care or their usual care plus access to SELF-BREATHE. All study participants will complete questionnaires at the start of the study, thereafter at seven and twelve weeks after randomisation.

These questionnaires will ask patients about 1) their breathlessness and its effect on their life and 2) planned and unplanned hospital visits. At the end of the study, we will compare answers to these questionnaires between the two groups at seven and 12 weeks.

This will tell if SELF-BREATHE improved patients' breathlessness and reduced their need for unplanned hospital visits e.g., A\&E attendances due to breathlessness. conditions: Chronic Obstructive Pulmonary Disease conditions: Bronchiectasis conditions: Interstitial Lung Disease conditions: Lung Cancer conditions: Asthma conditions: Dyspnea conditions: Fibrotic Lung Disease conditions: Chronic Lung Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: A statistician blind whoMasked: INVESTIGATOR count: 246 type: ESTIMATED name: SELF-BREATHE measure: Numerical Rating Scale (NRS) Worst Breathlessness sex: ALL minimumAge: 18 Years maximumAge: 110 Years stdAges: ADULT stdAges: OLDER_ADULT facility: King's College Hospital NHS Foundation Trust city: London zip: MK40 4DG country: United Kingdom name: Charles C Reilly role: CONTACT phone: 00442032998062 email: charles.reilly@nhs.net lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06326944 id: MS-527-2023 briefTitle: Fascia Transversalis Versus Transversus Abdominis Plane Block for Children Undergoing Inguinal Hernia Surgery overallStatus: RECRUITING date: 2024-01-18 date: 2024-04 date: 2024-05 date: 2024-03-22 date: 2024-03-22 name: Kasr El Aini Hospital class: OTHER briefSummary: Fascia transversalis block in pediatrics undergoing inguinal surgical repair may be simple technique and may give longer effect in reduction of post-operative pain in comparison to transversus abdominis plane block. conditions: Fascia Transversalis Plane Block studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Ultrasound- guided Fascia Transversalis plane block name: Ultrasound-guided Transversus abdominus plane block name: Fentanyl name: Pethidine name: Acetaminophen measure: Time to First need of analgesia measure: Total Pethidine Consumption measure: Postoperative pain assessment FLACC sex: ALL minimumAge: 1 Year maximumAge: 6 Years stdAges: CHILD facility: Cairo University Hospitals status: RECRUITING city: Giza zip: 11562 country: Egypt name: Maher a Fawzy, MD role: CONTACT phone: 01201730249 email: kasralainirec@kasralainy.edu.eg lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06326931 id: JE001 briefTitle: Thermal Pulsation Versus Warm Compress Treatment for Meibomian Gland Dysfunction overallStatus: COMPLETED date: 2022-06-24 date: 2023-06-22 date: 2023-06-22 date: 2024-03-22 date: 2024-03-22 name: Jacksoneye class: OTHER briefSummary: This study aimed to assess the treatment outcome differences between a single, in-office bilateral treatment with the thermal pulsation system and twice-daily, 10-minute applications of the warm compress mask at home for 8 weeks. conditions: Meibomian Gland Dysfunction studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomized, controlled clinical trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The clinician evaluating MGS score was masked to subject treatment assignment whoMasked: OUTCOMES_ASSESSOR count: 68 type: ACTUAL name: thermal pulsation name: warm compress measure: Change in MGS score for the worse eye measure: Change in MGS score for the worse eye measure: Change in OSDI score measure: Change in OSDI score measure: Incidence of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jacksoneye city: Lake Villa state: Illinois zip: 60046 country: United States lat: 42.41697 lon: -88.07397 hasResults: False

 nctId: NCT06326918 id: RP026 briefTitle: Duodenal Microbiota in Functional Dyspepsia overallStatus: RECRUITING date: 2024-02-12 date: 2024-12-31 date: 2025-06-30 date: 2024-03-22 date: 2024-03-22 name: King Chulalongkorn Memorial Hospital class: OTHER briefSummary: The goal of this observational study is to assess the type of duodenal microbiota and duodenal microbiome in in FD patients compared to control group. The main questions it aims to answer are:

* What are the differences in the type of duodenal microbiota and is there a difference in duodenal microbiome diversity between patients diagnosed with functional dyspepsia (FD) and the control group?
* Are there any significant variations in the composition and diversity of gut microbiota between patients with FD and the control group, considering the method of sample collection (duodenal brushing vs. duodenal biopsy)? conditions: Functional Dyspepsia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED name: Duodenal mucosal brushing name: Duodenal mucosal biopsy measure: Specific microbial genus using mucosal brushing measure: Microbiome diversity using mucosal brushing measure: Specific microbial genus using mucosal biopsy measure: Microbiome diversity using mucosal biopsy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: King Chulalongkorn Memorial Hospital status: RECRUITING city: Bangkok zip: 10330 country: Thailand name: Rapat Pittayanon, MD role: CONTACT phone: +66813132112 email: rapat125@gmail.com name: Chatpol Samuthpongtorn, MD role: CONTACT phone: +66813462108 email: csamuthpongtorn@gmail.com lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06326905 id: IRB00437750 id: K23DK133677-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/K23DK133677-01A1 briefTitle: CAPABLE Transplant overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-09-01 date: 2026-05-01 date: 2024-03-22 date: 2024-03-22 name: Johns Hopkins University class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The purpose of this mixed methods study is to adapt CAPABLE as CAPABLE Transplant to accomplish two things: 1) To resolve barriers to being classified as active on the Kidney Transplant (KT) waitlist and 2) as a surgical prehabilitation intervention targeting the pre-frail/ frail KT waitlist population. It consists of two phases- an open label pilot and a randomized waitlist control trial. conditions: Quality of Life conditions: Depression conditions: End Stage Renal Disease conditions: Disability Physical studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Waitlist Control Trial primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The assessment collector will be blinded as to whether a participant is in the intervention or waitlist group whoMasked: OUTCOMES_ASSESSOR count: 33 type: ESTIMATED name: CAPABLE Transplant- Open Label Pilot name: CAPABLE Transplant- Randomized Control Trial measure: Waitlist-status as assessed by data obtained by the National Kidney Registry measure: Change in self-efficacy as assessed by the Coping Self-Efficacy Instrument measure: Change in self-efficacy as assessed by the Self-Efficacy of Chronic Disease Management Instrument measure: Change in Pain as assessed by the Brief Pain Inventory measure: Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8) measure: Change in Social engagement as assessed by the Lubben Social Network Scale measure: Change in Social engagement as assessed by the Krause-Borawski-Clark Support Interactions Scale measure: Change in Fatigue/Quality of Life as assessed by the Kidney disease Quality of Life Scale measure: Change in Frailty as assessed by the Fried Frailty Phenotype measure: Change in Health Team Communication as assessed by the CollaboRATE Scale Measure measure: Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale measure: Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living measure: Acceptability at endpoint of intervention assessed by survey measure: Feasibility as assessed by qualitative questions measure: Fidelity as assessed by percent completion of intervention items sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins School of Nursing city: Baltimore state: Maryland zip: 21205 country: United States name: Samantha Curriero, MPH role: CONTACT phone: 443-699-1220 lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06326892 id: CHR1-101-2024 briefTitle: Natural Orifice Specimen Extraction in Low Rectal Cancer Surgery acronym: NOSES overallStatus: RECRUITING date: 2023-07-31 date: 2024-04-30 date: 2024-10-15 date: 2024-03-22 date: 2024-03-25 name: Istituto Clinico Humanitas class: OTHER briefSummary: This study aims to compare the postoperative outcomes of low rectal cancer patients who underwent surgery with Natural Orifice Specimen Extraction (NOSE) versus traditional Pfannenstiel extraction. conditions: Rectal Cancer conditions: Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 350 type: ESTIMATED name: Natural Orifice Specimen Extraction (NOSE) name: Traditional specimen extraction measure: Surgical Site Infections (SSI) measure: Opioid rescue measure: Postoperative pain measure: Postoperative ileus measure: Incisional hernia measure: Overall postoperative complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Humanitas Research Hospital status: RECRUITING city: Rozzano state: MI zip: 20089 country: Italy name: Annalisa Maroli, PhD role: CONTACT phone: 02 8224 7776 phoneExt: 0039 email: colorapp@humanitas.it name: Stefano De Zanet, MS role: CONTACT phone: 02 8224 4623 phoneExt: 0039 email: colorapp@humanitas.it lat: 45.38193 lon: 9.1559 hasResults: False

 nctId: NCT06326879 id: 3527 briefTitle: A Comparative Study Between Early Onset Colorectal Cancer and Late Onset Colorectal Cancer Patients acronym: EOrOS overallStatus: RECRUITING date: 2023-11-30 date: 2026-12-31 date: 2027-10-30 date: 2024-03-22 date: 2024-03-25 name: Istituto Clinico Humanitas class: OTHER briefSummary: This study aims to investigate the clinical, socioeconomic, behavioral, genetic, and molecular factors characterizing Early Onset Colorectal Cancer (EOCRC) patients compared with Late Onset Colorectal Cancer (LOCRC) patients conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 340 type: ESTIMATED name: No intervention measure: Incidence rate ratio of colorectal cancer recurrence measure: Correlation between lifestyle and incidence rate of colorectal cancer recurrence measure: Correlation between genetic profile and incidence rate of colorectal cancer recurrence measure: Correlation between molecular profile and incidence rate of colorectal cancer recurrence measure: Correlation between socioeconomic characteristics and incidence rate of colorectal cancer recurrence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Humanitas Research Hospital status: RECRUITING city: Rozzano state: MI zip: 20089 country: Italy name: Annalisa Maroli, PhD role: CONTACT phone: 02 8224 7776 phoneExt: 0039 email: colorapp@humanitas.it name: Stefano De Zanet, MS role: CONTACT phone: 02 8224 4623 phoneExt: 0039 email: colorapp@humanitas.it lat: 45.38193 lon: 9.1559 hasResults: False

 nctId: NCT06326866 id: E-74555795-050.04-941208 briefTitle: Otoacoustic Emissions in Different Blood Types overallStatus: COMPLETED date: 2024-02-07 date: 2024-03-12 date: 2024-03-18 date: 2024-03-22 date: 2024-03-26 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: The objective of this study is to examine whether ABO and Rhesus (Rh) blood group systems have an association with distortion product otoacoustic emission (DPOAE) and transient otoacoustic emission (TEOAE) amplitudes with the hypothesis of blood groups may affect hearing thresholds. conditions: Hearing Loss, Cochlear studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 70 type: ACTUAL name: Otoacoustic emissions (non-invasive) measure: Signal to noise ratios sex: ALL minimumAge: 18 Years maximumAge: 26 Years stdAges: ADULT facility: Eyyup KARA city: İstanbul zip: 34107 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06326853 id: Adipofisi briefTitle: Neuroendocrine Mechanisms in Adiposity: An Integrated Approach to the Characterization of Potential Pharmacological Novel Targets Based on Experimental and Clinical Models overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-03 date: 2026-12 date: 2024-03-22 date: 2024-03-25 name: IRCCS San Raffaele class: OTHER briefSummary: The goal of this observational study is to evaluate, retrospectively and prospectively, the effect of different hormonal and neuropeptide dysfunctions on the body composition of patients suffering from hypothalamic-pituitary pathologies, and to evaluate the potential beneficial effect of surgical and medical treatments with agonists and antagonists of hypothalamic neuropeptides, currently available, on the development and treatment of adiposity and negative cross-talk between adiposity and muscle/bone tissue conditions: Endocrine Disorders conditions: Adiposity conditions: Pituitary Adenoma conditions: Cushing Syndrome conditions: Acromegaly conditions: Hypopituitarism studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 200 type: ESTIMATED measure: Rate of patients with BMI greater than 30 with hypothalamic-pituitary pathologies sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06326840 id: 98107 briefTitle: Clinical Efficacy and Adverse Reactions of Antipsychotic Treatment overallStatus: COMPLETED date: 2010-05-31 date: 2011-06-10 date: 2011-06-10 date: 2024-03-22 date: 2024-03-22 name: Taipei Medical University Hospital class: OTHER name: Taipei Medical University briefSummary: The goal of this clinical trial is to explore the potential of metformin in managing olanzapine-induced metabolic disturbance and hyperprolactinemia in patients with schizophrenia. The main questions it aims to answer are:

1. The effect of metformin on olanzapine-induced metabolic disturbance
2. The effect of metformin on olanzapine-induced hyperprolactinemia

Participants will receive metformin 1500 mg/day for 8 weeks and assessments every 2 weeks. conditions: Metabolic Disturbance conditions: Hyperprolactinemia conditions: Schizophrenia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 42 type: ACTUAL name: Metformin measure: Glucose level measure: prolactin level measure: Insulin level measure: low-density lipoprotein cholesterol (LDL-C) level measure: high-density lipoprotein cholesterol (HDL-C) level measure: cholesterol level measure: triglycerides level measure: leptin level measure: Clinical Global Impression scale sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Taipei Medical University-Wan Fang Hospital city: Taipei zip: 116 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06326827 id: P231127IBSORTHO briefTitle: In'Oss™ (MBCP® Putty) Ortho overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-08 date: 2024-03-22 date: 2024-03-29 name: Advanced Medical Solutions Ltd. class: INDUSTRY briefSummary: Study of the osteoconductive potential of the injectable bone substitute In'Oss™ (MBCP® Putty) in the filling of orthopaedic bone defects to collect Post-Market Clinical Follow-up (PMCF) data for the CE-marked In'Oss™ (MBCP® Putty) device in the orthopaedic trauma surgery conditions: Orthopedic Disorder conditions: Trauma Injury conditions: Extremity Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: In'Oss™ (MBCP® Putty) measure: Successful bone defect reconstruction in the extremities measure: Evaluation of functional mobility restoration in the extremities with PRO measures measure: Evaluation of patient's pain intensity with VAS pain scale measure: Evaluation of safety of In'Oss measure: Evaluation of device usability sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06326814 id: TDU16837 id: U1111-1298-7281 type: REGISTRY domain: ICTRP briefTitle: A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy Adults overallStatus: COMPLETED date: 2021-10-11 date: 2023-05-05 date: 2023-05-05 date: 2024-03-22 date: 2024-03-22 name: Sanofi class: INDUSTRY briefSummary: Primary objective

* The tolerability and safety of SAR443809 Secondary
* The PK parameters of SAR443809
* The PD activity of SAR443809
* The immunogenicity of SAR443809 conditions: Paroxysmal Nocturnal Hemoglobinuria studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 54 type: ACTUAL name: Humanized anti-Factor Bb monoclonal antibody name: Placebo measure: Number of participants with adverse events (AEs)/treatment-emergent adverse events (TEAEs) measure: Incidence of potentially Clinical laboratory abnormalities measure: PK parameters of SAR443809 for IV and SC administrations: Maximum plasma concentration observed (Cmax measure: PK parameters of SAR443809 for IV and SC administrations: First time to reach Cmax (tmax measure: PK parameters of SAR443809 for IV and SC administrations: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to tlast (AUClast) measure: PK parameters of SAR443809 for IV and SC administrations: Area under the plasma concentration versus time curve extrapolated to infinity (AUC0-∞) measure: PK parameters of SAR443809 for IV and SC administrations: Terminal half-life associated with the terminal slope (λz) (t1/2z) measure: PK parameters of SAR443809 for IV and SC administrations: Time corresponding to the last concentration above the limit of quantification (Clast tlast) measure: PK parameters of SAR443809 for IV and SC administrations: total body clearance of a drug from the plasma calculated by dividing dose by AUC (CL) measure: PK parameters of SAR443809 for SC administrations: apparent total body clearance of the SC formulation (CL/F) measure: PK parameters of SAR443809 for IV and SC administrations: volume of distribution at steady-state (Vss) measure: PK parameters of SAR443809 for SC administrations: apparent volume of distribution at steady-state (Vss/F) measure: PK parameters of SAR443809 for SC administrations: absolute bioavailability (F) measure: Complement alternative pathway activity (Wieslab AP and alternative pathway hemolytic activity [AH50]) measure: Complement classical pathway activity (Wieslab CP) measure: Incidence of treatment -emergent Anti-SAR443809 antibodies sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Parexel International Site Number : 8400002 city: Glendale state: California zip: 91206 country: United States lat: 34.14251 lon: -118.25508 facility: Parexel International Site Number : 8400003 city: Baltimore state: Maryland zip: 21255 country: United States lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06326801 id: REC/014220 Muhammad Iqbal briefTitle: Resistive Diaphragmatic Breathing Exercise With Pursed Lips Breathing Exercise in Sub-acute Stroke Patients overallStatus: COMPLETED date: 2023-09-01 date: 2024-01-15 date: 2024-01-18 date: 2024-03-22 date: 2024-03-22 name: Riphah International University class: OTHER briefSummary: To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve pulmonary function in sub-acute ischemic stroke, To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve Trunk Control in sub-acute ischemic stroke, To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve Functional Capacity in sub-acute ischemic stroke conditions: Stroke, Ischemic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 27 type: ACTUAL name: Resistive Diaphragmatic breathing exercise name: Diaphragmatic breathing exercise name: Conventional stroke physiotherapy measure: pulmonary function measure: Trunk Control measure: Functional Capacity sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwest General Hospital, Peshawar; city: Peshawar state: Punjab zip: 44000 country: Pakistan lat: 34.008 lon: 71.57849 hasResults: False

 nctId: NCT06326788 id: 3912 Mehnoor Butt briefTitle: Effects of Moderate Intensity Soleus Push-ups vs Sustained Soleus Push-ups on Lipid Profile Among Young Population overallStatus: RECRUITING date: 2023-10-01 date: 2024-07-28 date: 2024-07-30 date: 2024-03-22 date: 2024-03-22 name: Riphah International University class: OTHER briefSummary: To determine the effects of Short duration moderate intensity soleus push- ups VS Sustained Soleus Push-ups on lipid profile among Young Population. conditions: Health Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 33 type: ESTIMATED name: Short Duration Moderate Intensity Soleus Push-ups name: SUSTAINED SOLEUS PUSH-UPS measure: Change in Lipid Profile measure: Adherence to Exercise Protocol sex: ALL minimumAge: 18 Years maximumAge: 26 Years stdAges: ADULT facility: Riphah Rehabilitation Center status: RECRUITING city: Islamabad zip: 46600 country: Pakistan name: Mehnoor Butt, MSPT role: CONTACT phone: 335 5400831 email: mehnoorarshad1109@gmail.com name: Waqar Ahmed Awan, PHD role: CONTACT phone: 333 5348846 email: waqar.ahmed@riphah.edu.pk lat: 33.72148 lon: 73.04329 hasResults: False

 nctId: NCT06326775 id: KY20240311-KS-02 briefTitle: Research on Precision Pharmaceutical Care for Heart Transplant Recipients overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-12 date: 2026-12 date: 2026-12 date: 2024-03-22 date: 2024-03-22 name: Nanjing First Hospital, Nanjing Medical University class: OTHER name: Wuhan Union Hospital, China name: Changhai Hospital name: Shanghai Zhongshan Hospital briefSummary: Establishing personalized dose prediction and related adverse drug reaction prediction models for immunosuppressive drugs after heart transplantation using multiple methods to construct a precise pharmaceutical service system for heart transplant patients has important research value and clinical significance in improving the safety and effectiveness of medication for patients. conditions: Heart Transplant Patients studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 500 type: ESTIMATED measure: Steady state whole blood trough concentration of tacrolimus sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Pharmacy Department of Nanjing First Hospital city: Nanjing state: Jiangsu zip: 210006 country: China lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06326762 id: younes briefTitle: Gap CO2 in Septic Patient to Predict Cardiomyopathy Septic overallStatus: COMPLETED date: 2023-01-01 date: 2023-10-30 date: 2023-10-30 date: 2024-03-22 date: 2024-03-22 name: Mohammed VI University Hospital class: OTHER briefSummary: the investigators included 98 patients admitted for sepsis and septic shock (68.4% men, 31.6% women) with an average age of 60.42 years ± 15.13, ranging from 21 to 96 years. The average length of hospital stay was 7.53 days. The most noted medical histories were diabetes (38.8%), hypertension (28.6%), and renal insufficiency (17.1%). Regarding laboratory findings: the mean white blood cell count was 15,985.16 cells/mm³, the mean C-reactive protein (CRP) level was 227.69 mg/L, and the mean procalcitonin level was 50.43 µg/L. In terms of blood gas analysis: the mean lactate level was 3.67 mmol/L, and the mean PCO2 gap (DELTAPCO2) was 4.85. All our patients were continuously monitored by pulse wave analysis: the mean cardiac output was 5.69 L/min, and the mean cardiac index was 4.14 L/s/m² All our patients underwent an echocardiogram, which is a routine examination in our department and is performed at the patient's bedside. The average left ventricular ejection fraction (LVEF) was 51.73%, and the average subaortic peak velocity (ITV) was 14.66 cm.

Subsequently. the investigators examined the clinical and paraclinical profile of patients with septic cardiomyopathy. the investigators identified 19 patients with this condition, while 79 patients did not exhibit cardiac involvement. The percentage was significantly higher in the population with cardiac involvement, accounting for 28.3%. Among the patients with cardiac involvement, 76.5% had a PCO2 gap (DELTAPCO2) ≥ 6 mmHg, a significantly reduced cardiac output with an average of 3.3 L/min, and a predominantly low cardiac index, with 64.3% having an index \< 2.2 L/min/m². The mortality rate was significantly increased at 73.7%. conditions: Gap co2 conditions: Cardiac Output, Low conditions: Cardiac Defect studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 98 type: ACTUAL name: comparaison measure: gapCO2 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: younes Oujidi city: Berkane zip: 9999 country: Morocco lat: 34.92 lon: -2.32 hasResults: False

 nctId: NCT06326749 id: 2024/19 briefTitle: Effectiveness of Modified Graded Motor Imagery Training in Stroke Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-11-15 date: 2025-03-15 date: 2024-03-22 date: 2024-03-22 name: Inonu University class: OTHER briefSummary: In the study, movement observation training, Modified Graded Motor Imaging Training, which includes upper extremity functional exercises, and Graded Motor Imaging Training, where the standard protocol is applied, will be used in stroke patients to improve their upper extremity motor functions and daily lives. It is aimed to present it on an evidence-based basis by investigating its effects on Daily Living Activity, quality of life, upper extremity-specific right/left lateralization performance, mental stopwatch performance and motor imagery skills. conditions: Graded Motor Imagery conditions: Stroke conditions: Action Observation Training conditions: Motor Imagery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 21 type: ESTIMATED name: Modified Graded Motor Imagery and Conventional Treatment Group name: Graded Motor Imagery and Conventional Treatment Group name: Conventional Treatment Group measure: Fugl-Meyer Upper Extremity Motor Rating Scale measure: Wolf Motor Function Test (WMFT) measure: Modified Barthel Index measure: Stroke-Specific Quality of Life Scale measure: Lateralization Assessment measure: Mental Chronometry Time measure: Kinesthetic and Visual Imagery Questionnaire (KGIA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inonu University city: Malatya zip: 44280 country: Turkey name: Havva ADLI role: CONTACT phone: 05369831133 email: h.adli@hotmail.com name: Kezban BAYRAMLAR, Prof. Dr. role: SUB_INVESTIGATOR lat: 38.35018 lon: 38.31667 hasResults: False

 nctId: NCT06326736 id: 2024NZKY-014-02 briefTitle: Study of Neoantigen mRNA Vaccines in Patients With Resectable Pancreatic Cancer overallStatus: RECRUITING date: 2024-04 date: 2025-12 date: 2026-12 date: 2024-03-22 date: 2024-03-22 name: Jinling Hospital, China class: OTHER name: Jiangsu Synthgene Biotechnology Co.Ltd. briefSummary: The purpose of this study is to evaluate the safety and efficacy of treating pancreatic cancer with surgery to remove cancerour tissue, followed by camrelizumab and a personalized cancer mRNA vaccines. conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Surgery name: Camrelizumab name: SJ-Neo006 name: Gemcitabine+Abraxane measure: Incidence of Treatment Emergent Adverse Events (TEAEs) measure: Disease control rate (DCR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wang Sizhen status: RECRUITING city: Nanjing state: Jiangsu country: China name: wu qiong role: CONTACT phone: 02580863234 lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06326723 id: SIM0808-101 briefTitle: Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects overallStatus: COMPLETED date: 2023-09-04 date: 2023-12-24 date: 2024-02-05 date: 2024-03-22 date: 2024-03-22 name: Jiangsu Simcere Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: This clinical study is a single-center, randomized, double-blind, placebo-controlled Phase 1 clinical study to assess the PK characteristics and safety and tolerability of single and multiple dose daridorexant in 32 healthy adult Chinese subjects. conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 32 type: ACTUAL name: Daridorexant measure: Pharmacokinetic Endpoints1 measure: Pharmacokinetic Endpoints2 measure: Pharmacokinetic Endpoints3 measure: Pharmacokinetic Endpoints4 measure: Pharmacokinetic Endpoints5 measure: Pharmacokinetic Endpoints6 measure: Pharmacokinetic Endpoints7 measure: Safety Endpoints1 measure: Safety Endpoints2 measure: Safety Endpoints3 measure: Safety Endpoints4 measure: Safety Endpoints5 measure: Safety Endpoints6 measure: Safety Endpoints7 measure: Safety Endpoints8 sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Nanjing Drum Tower hospital city: Nanjing state: Jiangsu zip: 210000 country: China lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06326710 id: P0045122 briefTitle: The 'Outdoor Rehab-Fit' App-based Physical Activity Education Intervention for Frail Older Adults in Hong Kong overallStatus: RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-12-31 date: 2024-03-22 date: 2024-04-09 name: The Hong Kong Polytechnic University class: OTHER briefSummary: In recent years, research teams around the world have developed interventions to educate older adults to use outdoor exercise facilities (OEFs) to improve health outcomes like strength, balance, mobility, PA level, and weight. These interventions employed trainers or therapists to instruct, and monitor exercise training for older adults using the public accessible OEFs. Apart from therapist or trainer-led intervention, an Australian research team developed a mobile application, and social support strategies to help participants to use OEFs to enhance their aerobic and resistance-based PA.

A recent local in-depth qualitative study discovered that OEFs in Hong Kong attracted frailer older adults (i.e., those who recovered from a major illness or who has chronic diseases), and their caregivers to use OEFs to support and maintain their daily PA behavior. Some used OEFs to complement their formal rehabilitation sessions. It appears that OEFs in Hong Kong serves as an important health maintenance space for frailer older adults in the city to "age in place", yet educational training related to OEFs has been lacking over the years. Signage besides the exercise equipment has been the only education material for users over the years.

A mobile app-based physical activity education intervention will be developed for frail old adults in Hong Kong. The intervention has two components: (1) mobile app; and (2) face-to-face group session that teaches the how to use correctly and safely use OEF in public parks to maintain PA habits.

The main objective of this study is to evaluate the feasibility, acceptability, and pilot effectiveness of the 'Outdoor Rehab-Fit' App-based physical activity education intervention. Primary outcomes include recruitment rate, retention rate, attrition rate, attendance, perceived usefulness of the app. Secondary outcomes include exercise self-efficacy, mental well-being, physical activity level.

This study adopts a mixed-method design with quantitative and qualitative method. This study is a pilot randomized controlled trial, running for 4 months evaluating of the effectiveness of the mHealth intervention. 40 frail older adults will be randomized into (i) mHealth group or (ii) control group.

Quantitative analysis will be adopted to investigate the effectiveness of the 'Outdoor Rehab-Fit' App-based physical activity education intervention on the health outcomes of frail older adults. The qualitative component will consist of semi-structure interviews with the frail older adults to understand the acceptability of the intervention. conditions: Physical Inactivity conditions: Frailty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: mHealth name: Health Talk measure: Feasibility outcome: Recruitment rate measure: Feasibility outcome: Intervention completion rate measure: Feasibility outcome: Attrition rate measure: Feasibility outcome: Attendance measure: Acceptability outcome: Perceived Usefulness on Outdoor Rehab-Fit App measure: Acceptability outcome: Participants' views about the barriers and facilitation of the mHealth program measure: Change in Physical activity level (Objective) at 1 month and 3 months measure: Change in Physical activity level (Subjective) at 1 month and 3 months measure: Change in Exercise self-efficacy at 1 month and 3 months measure: Change in Mental well-being at 1 month and 3 months measure: Change in usage of outdoor exercise facilities sex: ALL minimumAge: 55 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Rehabilitation Sciences, The Hong Kong Polytechnic University status: RECRUITING city: Hong Kong country: Hong Kong name: Janet Lok Chun Lee, PhD role: CONTACT email: lcjlee@polyu.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06326697 id: HIK-AZA-2023-01 briefTitle: Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-01 date: 2025-03 date: 2024-03-22 date: 2024-03-22 name: Hikma Pharmaceuticals LLC class: INDUSTRY briefSummary: A Randomized, Single Oral Dose, Open Label, Two Treatment, Crossover study to investigate the bioequivalence of the Test Product Azacitidine 300 mg Film coated tablets relative to Reference Product Onureg® 300 mg Film Coated Tablets in adult patients with AML under fasting conditions conditions: Acute Myeloid Leukaemia studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 32 type: ESTIMATED name: Azacitidine name: Onureg measure: Cmax measure: AUC0-t measure: AUC0-∞ measure: Kel measure: Tmax measure: T1/2el measure: Adverse Events (AEs) measure: Change in clinical safety labs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06326684 id: 88524 briefTitle: Suvorexant and Alcohol overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2027-03-15 date: 2027-03-15 date: 2024-03-22 date: 2024-03-27 name: University of Kentucky class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: This research will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of alcohol in humans. As such, the outcomes will contribute to our understanding of the clinical neurobiology of Alcohol Use Disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on alcohol addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans. conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Alcohol name: Placebo name: Suvorexant name: Suvorexant measure: Reinforcing Effects of Alcohol measure: Craving measure: Mood measure: Alcohol Response measure: Heart rate measure: Blood pressure measure: Breath Alcohol Level measure: Temperature measure: Side Effects measure: Delay Discounting measure: n-back Task measure: Stop-Signal Task Inhibitory Failures measure: Sleep sex: ALL minimumAge: 21 Years maximumAge: 55 Years stdAges: ADULT facility: Psychopharmacology of Addiction Laboratory city: Lexington state: Kentucky zip: 40507 country: United States name: William Walton Stoops role: CONTACT phone: 8592575388 email: william.stoops@uky.edu name: William W Stoops, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.98869 lon: -84.47772 hasResults: False

 nctId: NCT06326671 id: STXA-BE-03 briefTitle: A Trial to Assess the Bioequivalence of Generic Tiotropium Bromide Inhalation Powder and Reference Product in Healthy Adult Participants Under Fasting Conditions (Pilot) overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-28 date: 2024-03 date: 2024-04 date: 2024-03-22 date: 2024-03-29 name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: Primary Objective: To evaluate the pharmacokinetics of Tiotropium Bromide Inhalation Powder (Strength:18 mcg; manufactured by Chia Tai Tianqing Pharmaceutical Group Co. Ltd) and reference products Tiotropium Bromide Inhalation Powder (Spiriva®, Handihaler®, Strength: 18mcg, manufactured by Boehringer Ingelheim Pharmaceuticals, Inc) by oral inhalation of single dose in healthy participants under fasting conditions. conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 39 type: ACTUAL name: Tiotropium Bromide Inhalation Powder name: Spiriva HandiHaler measure: Peak concentration (Cmax) measure: Area under the plasma concentration versus time curve (AUC) 0-t measure: Area under the plasma concentration versus time curve (AUC) 0-∞ measure: The time to maximum plasma concentration (Tmax) measure: The elimination half-life (t1/2) measure: Terminal elimination rate constant (Kel) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Henan (Zhengzhou) Zhonghui Cardiovascular Hospital city: Zhengzhou state: Henan zip: 450003 country: China lat: 34.75778 lon: 113.64861 hasResults: False

 nctId: NCT06326658 id: TCM for Frequent AECOPD briefTitle: Bufei Yishen Prescription on Patients With Frequent AECOPD in Stable Stage overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-05-01 date: 2026-10-31 date: 2024-03-22 date: 2024-03-22 name: Henan University of Traditional Chinese Medicine class: OTHER name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine name: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine briefSummary: To evaluate the clinical efficacy and health economic advantages of Lung Replenishing and Kidney Enhancing Formula for the treatment of patients with frequent acute exacerbations in the stabilized phase. conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 848 type: ESTIMATED name: Bufei Yishen Prescription Granule measure: The number of acute exacerbations measure: The number of AECOPD leading to hospitalization and death measure: Time of onset of the first AECOPD measure: Severity of AECOPD measure: Duration of AECOPD measure: Case fatality rate measure: Lung function measure: Score for clinical signs and symptoms measure: 6-minute walking distance (6MWD) measure: The Chronic Obstructive Pulmonary Patient Self-Assessment Test (CAT) measure: The MOS item short fromhealth survey（SF-36） sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06326645 id: IRB23-891 briefTitle: Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-12-01 date: 2025-12-01 date: 2025-12-01 date: 2024-03-22 date: 2024-03-22 name: Lindsey Russell, MD class: OTHER name: Napo Pharmaceuticals, Inc. briefSummary: The objectives of this study are to evaluate the efficacy and safety of crofelemer treatment in adults affected by Short Bowel Syndrome (SBS) with an ileostomy on parenteral support (PS) in reducing output or PS needs. Crofelemer will be provided as a powder three times daily for 12 weeks and a 4 week follow up. . conditions: Short Bowel Syndrome studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Small exploratory study primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Crofelemer Oral Product measure: Ostomy output reduction measure: Change in average weekly Parenteral Support (PS) volume measure: Change in SBS-QoL (Short bowel syndrome quality of life) measure: Change in GSRS (Gastrointestinal Symptom Rating Scale) measure: Change in intestinal absorption of fluids and macronutrients with consequent reduction of macronutrient requirements in patients with SBS measure: Change in weekly need for parenteral electrolytes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic Main Campus city: Cleveland state: Ohio zip: 44106 country: United States name: Lindsey A Russell, MD role: CONTACT lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06326632 id: RHPT/0022/023 briefTitle: Comparative Effectiveness Study of Constant-Load Versus Graded Aerobic Exercise in Obese Children With Bronchial Asthma overallStatus: COMPLETED date: 2022-10-30 date: 2023-12-07 date: 2023-12-07 date: 2024-03-22 date: 2024-03-22 name: Cairo University class: OTHER briefSummary: This study aimed to compare the effect of constant-load aerobic exercise (CL-AE) and graded aerobic exercise (G-AE) on cardiopulmonary fitness, and functional capacity in a cohort of obese children with bronchial asthma (BA).

A total of 78 children with BA were randomly assigned to the CL-AE group (n = 26, who underwent moderate-intensity aerobic training with the training load maintained at the same level throughout the entire program, besides the respiratory re-training program), the G-AE group (n = 26, received an intensity- and duration-graded aerobic training in addition to the respiratory re-training program), or the control group (n = 29, who only engaged in a respiratory re-training program). Interventions were administered three times/week for 12 successive weeks.

The cardiopulmonary fitness and functional capacity were evaluated in the three groups before and after the completion of the assigned interventions. conditions: Bronchial Asthma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A prospective, three-arm, randomized controlled trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: A single-blind protocol was adopted. The researcher who collected the data was blind to the allocation of treatment whoMasked: OUTCOMES_ASSESSOR count: 78 type: ACTUAL name: Constant-load Aerobic Exercise name: Graded Aerobic exercise name: Respiratory Re-training measure: Peak oxygen uptake measure: Six-minute walk test measure: Dyspnea measure: Fatigue sex: ALL minimumAge: 8 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Ragab K. Elnaggar city: Al Kharj state: Riyadh country: Saudi Arabia lat: 24.15541 lon: 47.33457 hasResults: False

 nctId: NCT06326619 id: SurvSysT briefTitle: Survival Benefit of Primary Tumour Resection Compared to Systemic Therapy Alone in Stage IV Colorectal Cancer Patients acronym: SurvSysT overallStatus: COMPLETED date: 2012-01-01 date: 2020-12-31 date: 2020-12-31 date: 2024-03-22 date: 2024-03-22 name: Medizinische Hochschule Brandenburg Theodor Fontane class: OTHER name: Clinical-Epidemiological Cancer Registry Brandenburg-Berlin briefSummary: About 20-25 percent of all colorectal cancer patients are diagnosed with International Union Against Cancer (UICC) stage IV disease. The benefit of primary tumor resection in the palliative context is therefore of high concern. However, empirical evidence from randomized and observational studies is inconsistent.

The objective of the present study is to compare the survival of palliative stage IV colorectal cancer patients selected for primary tumor resection and systemic treatment (PTR+SYST) to patients with systemic treatment only (SYST). conditions: Colorectal Cancer conditions: Neoadjuvant Systemic Therapy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 480 type: ACTUAL name: Primary tumor resection name: Systemic Therapy measure: Survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06326606 id: 23-MLS101-101 briefTitle: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants overallStatus: RECRUITING date: 2024-03 date: 2024-09 date: 2024-10 date: 2024-03-22 date: 2024-03-22 name: MycoMedica Life Sciences PBC class: INDUSTRY briefSummary: MLS101 is being developed as a low dose psilocybin, that can be administered to treat various neurological and psychiatric conditions.

The purpose of this clinical trial is to assess how safe and tolerated MLS101 is; to see how MLS101 is distributed and cleared by the body (pharmacokinetics); and to assess the psychedelic effects of MLS101 in healthy adult participants. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomized, double-blind, placebo-controlled, single ascending and multiple dose study to assess the safety, tolerability, and pharmacokinetics of MLS101 in healthy participants. The study consists of 2 parts:

Part 1 - Single Ascending Dose (SAD): 24 participants will be enrolled in 3 sequential dose cohorts and will be randomized to receive a single dose of MLS101 or placebo. Additional cohorts (comprising 8 participants in each cohort) may be enrolled to explore more doses.

Part 2: Multiple Dose study, doses and administration regimens are pending the results from Part 1 primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Psilocybin name: Placebo measure: Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs) measure: Occurrence of clinically significant changes in physical examination, vital signs, ECGs, clinical laboratory tests, the Columbia-Suicide Severity Rating Scale (C-SSRS). measure: Pharmacokinetics of MLS101: maximum observed serum concentration (Cmax) measure: Pharmacokinetics of MLS10: area under the plasma concentration-time curve (AUC) measure: Pharmacokinetics of MLS101: time corresponding to the occurrence of Cmax (tmax) measure: Pharmacokinetics of MLS101: apparent terminal elimination half-life (t½) measure: Pharmacokinetics of MLS101: apparent total systemic clearance after oral administration (CL/F) measure: Pharmacokinetics of MLS101: apparent volume of distribution during the terminal phase (Vz/F) measure: Sensorial effects of MLS101 measure: Cognitive function sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CMAX Clinical Research Pty Ltd status: RECRUITING city: Adelaide state: South Australia zip: 5000 country: Australia name: Eloise Spooner role: CONTACT phone: +61 8 7088 7900 email: eloise.spooner@cmax.com.au name: Sepehr Shakib role: PRINCIPAL_INVESTIGATOR lat: -34.92866 lon: 138.59863 hasResults: False

 nctId: NCT06326593 id: P.T.REC/012/005049 briefTitle: Wii Aerobic Training in Inhalation-injury Children Post-thermal Burn overallStatus: RECRUITING date: 2024-02-22 date: 2024-05-25 date: 2024-06-01 date: 2024-03-22 date: 2024-03-22 name: MTI University class: OTHER briefSummary: Inhalation injury is a composite of multiple insults including: supra glottic thermal injury, subglottic airway and alveolar poisoning, and systemic poisoning from absorbed small molecule toxins. These contaminant insults independently affect each of the pulmonary functions as well as having a direct effect on systemic physiology. Further, anatomic characteristics can predispose patients to inhalation injury. For example, an infant will develop airway obstructions much faster than an adult due to reduced airway diameter. Understanding the contributions of each of these pathologies to the patient's disease is critical to managing inhalation injury.

Wii fit aerobic training gives similar results with traditional rehabilitation practices, it causes less energy costs. This suggests that it can be a suitable rehabilitation tool for adult and elderly people with low energy levels. A review showed that video games are safe and feasible in the children with lung complications. Children' balance, aerobic and cognitive functions, quality of life improved and depressive mood decreased. WII aerobic games also make children to communicate better with other family members. conditions: Inhalation Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Wii aerobic training name: conservative chest care measure: Forced vital capacity (FVC) measure: forced expiratory volume in 1 second (FEV1) measure: peak expiratory flow (PEF) measure: Upper and lower chest expansion (2nd intercostal space, xiphoid)]) measure: Functional capacity 6-Minute Walk Test (6-MWT) measure: Timed Up and Go test (TUG) sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: Heba Elfeky status: RECRUITING city: Cairo zip: 6347113 country: Egypt name: ahmed m el fahl, phd role: CONTACT phone: 00201097782441 email: nn_ee_mm_oo@yahoo.com lat: 30.06263 lon: 31.24967 facility: Ahmed Mohamed Ahmed Abdelhady status: RECRUITING city: Cairo country: Egypt name: Ahmed El Fahl, ph.d role: CONTACT lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06326580 id: MS.22.09.2144 briefTitle: Clinical Prediction Model of Obstructive Sleep Apnea at Mansoura University Hospitals overallStatus: COMPLETED date: 2022-10-20 date: 2023-10-20 date: 2024-02-20 date: 2024-03-22 date: 2024-03-22 name: Mansoura University class: OTHER briefSummary: Obstructive sleep apnea syndrome (OSAS)is a sleep breathing disorder manifested by complete apnea or partial hypopnea obstruction of the upper airway, which often remains undiagnosed and untreated (Kuczynski, W., 2019). These episodes, which should be more than 5 per hour and last at least 10 s, can lead to a sleep fragmentation and hypoxia (Huon, L.-K.A., 2017). OSAS predominantly affects 26% of individuals between 30 and 70 years in the U.S (apnea hypopnea index ≥5 events per hour) (Schwartz, M., 2018).

Obstructive sleep apnea it is increasingly recognized as an independent risk factor for cardiac, neurologic, and perioperative morbidities. Yet this disorder remains undiagnosed in a substantial portion of our population. It is imperative for all physicians to remain vigilant in identifying patients with signs and symptoms consistent with OSA (Park, J. G., 2011).

The test of hypothesis is to design a clinical prediction model of obstructive sleep apnea from collected data of the patients having symptoms of obstructive sleep apnea and the results of their sleep study conditions: Osa Syndrome studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 1129 type: ACTUAL measure: The recorded data of all patients which include all their symptoms and comorbidities as well as their use of any regular medications will be collected. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mansoura University city: Mansoura state: Dakhlia zip: 050 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06326567 id: 84032 briefTitle: Comprehensive Connected Cancer Care (C4): Intervention Evaluation overallStatus: RECRUITING date: 2024-02-01 date: 2025-06 date: 2025-06 date: 2024-03-22 date: 2024-03-22 name: Timothy Mullett class: OTHER name: Merck Sharp & Dohme LLC briefSummary: The C4 program aims to provide a multi-level intervention program (Patient Level, Healthcare Team and Healthcare System Level) that improves the coordination of care with supportive/ancillary care providers and community services through the use of patient navigation and a digital needs assessment and a closed-loop referral system and improves patient-centered communication and engagement in care through skills training for the healthcare team and provision of culturally appropriate patient educational tools and resources. The program components incorporate three areas that are critical to improving patient-centered care: coordination of care, patient-centered communication and engagement, and psychosocial care and other supportive services. conditions: Cancer conditions: Health Care Utilization studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 300 type: ESTIMATED name: C4 Program measure: Change in Health Related Quality of Life (FACT-G7) measure: Overall Survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Kentucky status: RECRUITING city: Lexington state: Kentucky zip: 40506 country: United States name: Yvonne Taul, RN role: CONTACT phone: 859-323-2354 email: Yvonne.Taul@uky.edu lat: 37.98869 lon: -84.47772 hasResults: False

 nctId: NCT06326554 id: 22-5933 briefTitle: Single Arm Pilot Trial of Virtual and In-person STEP2 acronym: STEP2 overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-01 date: 2025-01-01 date: 2024-03-22 date: 2024-03-22 name: University Health Network, Toronto class: OTHER briefSummary: The goal of this clinical trial is to assess the feasibility of offering oncology patients a referral to the outpatient palliative care clinic based on virtual symptom screening before oncology clinic appointments, and to qualitatively explore factors patients consider when deciding to accept or defer a visit to this clinic.

Participants will be asked to complete questionnaires assessing quality of life, symptom burden, depression, anxiety, and satisfaction with care at baseline, 2, 4, and 6 months. conditions: Oncology studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single arm intervention primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2) measure: FACIT-PAL 14 measure: FACIT-PAL 14 measure: ESAS-r-CS measure: PHQ-9 measure: FAMCARE-P16 measure: Generalized Anxiety Disorder-7 measure: Patient Global Impression of Change sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06326541 id: okutan briefTitle: The Effect of Listening to the Holy Quran on Vital Signs in Coma Patients overallStatus: COMPLETED date: 2023-01-05 date: 2023-12-10 date: 2023-12-30 date: 2024-03-22 date: 2024-03-22 name: Bitlis Eren University class: OTHER briefSummary: The aim of this study is to examine the effect of the Holy Quran listened to to coma patients on their vital signs.

Does listening to the Holy Quran have a positive effect on the life values of coma patients? conditions: Sequelae of; Complications Surgical and Medical Care studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: single group pretest-posttest primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 72 type: ACTUAL name: music therapy measure: systolic blood pressure- (mmHg) measure: diastolic blood pressure- (mmHg) measure: pulse (number of beats/min) measure: body temperature (degrees Celsius) measure: saturation (%-oxygen saturation) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Bitlis Eren University city: Bitlis zip: 13100 country: Turkey lat: 38.40115 lon: 42.10784 hasResults: False

 nctId: NCT06326528 id: SGLT2 inhibitors briefTitle: SGLT2 Inhibitors and Perioperative Period overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-01 date: 2025-10-01 date: 2024-03-22 date: 2024-03-22 name: Assiut University class: OTHER briefSummary: The expanded use of SGLT2 inhibitors motivates us to assess the role of SGLT2 inhibitors in perioperative period on patients who will undergo cardiac surgery in Assiut University. conditions: Perioperative Complication studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: SGLT2 inhibitor measure: Difference of cardiac function by speckle tracing between patients who will receive SGLT2 and patients who not. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06326515 id: Government College University briefTitle: Cognitive Behavior Therapy for Depression, Stigmatization, Criminogenic Cognition, and Quality of Life Among Patients With Opioid Use Disorder (OUD): A Randomized Control Trial. acronym: CBT with OUD overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2024-07-20 date: 2024-09-10 date: 2024-03-22 date: 2024-03-22 name: Government College University Faisalabad class: OTHER briefSummary: to investigate the impact of cognitive behavior therapy for psychiatric problems among patients with opioid use disorder with relapse condition.

In this randomize control trail (RCT), N=120 patients with relapse condition would be taken. After enrolment patients' eligibility assessment would be completed and then n=60 patients would be allocated to experimental (n=30) and waitlist control (n=30) through random assignment. Patient's age range would be between 20 to 30 years. conditions: Psychoeducation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized control trial design would be used in this study. It would be two arm study and there would be two groups an experimental and wait-list control group. Experimental group will receive intervention and another group would be placed in waitlist. In this research, parallel group design would be used. We will give treatment to all participants in a parallel way. Allocation ratio and framework would be equivalence i.e., treatment group and control group would be equal number of participants primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: psychoeducation name: Stigma Reduction and Relapse Management measure: The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST; Henry-Edwards et al., 2003; Hussain et al., 2022). measure: Criminogenic Cognition Scale (CCS;Tangney, at el, 2012; Jamil & Fatima, 2018): measure: Patient Health Questionnaire (PHQ-9; Robert et al. 1999; Ahmad et al, 2018). measure: Relapse Risk Scale (RRS; Marlatt & Gordon, 1985; Hussain et al., 2016): measure: Perceived Stigma of Addiction Scale measure: Brief Cope Inventory (BCI) measure: World Health Organization Quality-of-Life Scale sex: ALL minimumAge: 20 Years maximumAge: 30 Years stdAges: ADULT facility: Dr Khalid Mahmood city: Faisalābad state: Punjab country: Pakistan lat: 31.41554 lon: 73.08969 hasResults: False

 nctId: NCT06326502 id: 22ETN101-2IND001 briefTitle: A Safety and Efficacy Study of Multiple Tyrosine Kinase Inhibitor Drug (ETN101) in Advanced Hepatocellular Carcinoma overallStatus: RECRUITING date: 2024-02-07 date: 2027-03-07 date: 2027-06-07 date: 2024-03-22 date: 2024-03-27 name: Etnova Therapeutics Corp. class: INDUSTRY briefSummary: ETN101 is a multiple tyrosine kinase inhibitor (mTKI) targeting fms-like tyrosine kinase 3 (FLT3), receptor tyrosine kinase (KIT), vascular endothelial growth factor receptor 2 (VEGFR2), and platelet-derived growth factor receptor beta. Both in vitro and in vivo studies showed that ETN101 treatment/administration inhibited cancer cell survival and proliferation. In animal models, ETN101 had antitumor activity when administered to animals that did not respond to conventional targeted anticancer agents. conditions: Hepatocellular Carcinoma conditions: Advanced Hepatocellular Carcinoma conditions: Liver Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: ETN101 measure: Dose-limiting Toxicity (DLT) sex: ALL minimumAge: 19 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital status: RECRUITING city: Seoul zip: 03080 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Severance Hospital status: RECRUITING city: Seoul zip: 03722 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06326489 id: 105122023-1/05.12.2023 id: ERP-2023-13520 type: OTHER_GRANT domain: Medtronic briefTitle: Evaluating the Efficacy and Quality of Life Impact of Transitioning to Advanced Hybrid Closed-Loop Insulin Pump Therapy in Romanian Children With Type 1 Diabetes Mellitus overallStatus: RECRUITING date: 2024-03-11 date: 2024-08-30 date: 2024-11-30 date: 2024-03-22 date: 2024-03-26 name: ELIAS Emergency University Hospital class: OTHER briefSummary: The proposed study aims to demonstrate the potential benefits of transitioning T1DM children from predictive low glucose suspend insulin pump therapy to advanced hybrid closed-loop insulin pump therapy in Romania. Primary Outcome: Variations in HbA1c between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G).

Secondary Outcomes: changes in insulin requirements, time in range (TIR) levels, time below range (TBR), coefficient of variation (CV), frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization, and PedsQL SF15 questionnaire scores. conditions: Diabetes Mellitus, Type 1 studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study will include 30 children with type 1 diabetes aged seven years and older who use a predictive low glucose suspend insulin pump (740G). Patients eligible for the study will receive a 780G insulin pump for three months. primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Switching to the Medtronic 780G insulin pump measure: Variations in HbA1c measure: changes in insulin requirements measure: changes in time in range (TIR) levels measure: changes in time below range (TBR) measure: changes in coefficient of variation (CV) measure: changes in frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization measure: changes in The Pediatric Quality of Life Inventory™ 4.0 Short Form 15 Generic Core Scales questionnaire scores sex: ALL minimumAge: 7 Years maximumAge: 17 Years stdAges: CHILD facility: Elias University Emergency Hospital status: RECRUITING city: Bucharest state: Sector 1 zip: 011461 country: Romania name: Sorin Ioacara, MD, PhD role: CONTACT phone: 0040213161600 email: drsorin@yahoo.com lat: 44.43225 lon: 26.10626 hasResults: False

 nctId: NCT06326476 id: IRB-300012699 id: 000544067 type: OTHER domain: University of Alabama at Birmingham briefTitle: A Study to Demonstrate the Safety and Efficacy of Siplizumab in the Treatment of Hidradenitis Suppurativa overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2025-09-30 date: 2025-12-31 date: 2024-03-22 date: 2024-03-22 name: University of Alabama at Birmingham class: OTHER name: ITB-Med LLC briefSummary: This study is to investigate the efficacy of siplizumab in the treatment of Hidradenitis Suppurativa. conditions: Hidradenitis Suppurativa studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Siplizumab measure: Change in inflammatory lesion counts measure: Change in Hidradenitis Suppurativa Clinical Response (HiSCR) measure: Change in Hurley Stage measure: Change in Dermatology Life Quality Index (DLQI) scores measure: Improvement in Visual Analogue Scale (VAS) pain scores measure: Change in Lesion Counts sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06326463 id: DIRECT70 id: NCI-2024-03240 type: OTHER domain: NCI Clinical Trial Registration Program briefTitle: CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2030-07-01 date: 2031-07-01 date: 2024-03-22 date: 2024-04-12 name: St. Jude Children's Research Hospital class: OTHER briefSummary: The study participant has one of the following blood cancers: acute myelogenous leukemia (AML)/myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (B-ALL, T-ALL) or Lymphoma. Your cancer has been difficult to treat (refractory) or has come back after treatment (relapse).

Primary Objective

To determine the safety and maximum tolerated dose of intravenous infusions of escalating doses of CD70-CAR T cells in patients (≤21 years) with recurrent/refractory CD70+ hematological malignancies after lymphodepleting chemotherapy.

Secondary Objectives

To evaluate the antileukemic activity of CD70-CAR T cells. We will determine the anti- leukemic activity of the CD70-CAR T cells in the bone marrow and in the treatment of extramedullary disease. conditions: Hematologic Malignancy conditions: ALL, Childhood conditions: AML, Childhood conditions: Lymphoma conditions: MDS studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Fludarabine name: Cyclophosphamide name: CD70-CAR T cell infusion (Autologous) name: Mesna measure: Maximum tolerated dose of CD70-CAR T cells sex: ALL maximumAge: 21 Years stdAges: CHILD stdAges: ADULT facility: St. Jude Children's Research Hospital city: Memphis state: Tennessee zip: 38105 country: United States name: Swati Naik, MD role: CONTACT phone: 866-278-5833 email: referralinfo@stjude.org lat: 35.14953 lon: -90.04898 hasResults: False

 nctId: NCT06326450 id: 74626 briefTitle: Traditional In-Person Vs. Remote AR Clinical Simulation acronym: AR Brazil overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-05-31 date: 2025-05-31 date: 2024-03-22 date: 2024-04-12 name: Stanford University class: OTHER briefSummary: This is a non-inferiority, international, controlled trial that aims to evaluate the progression of physicians and residents through an Advanced Cardiac Life Support (ACLS) clinical simulated scenario. The study's primary objective is to compare the performance outcomes between two groups: participants in the traditional in-person simulation and those immersed in the Augmented Reality (AR) scenario conditions: Educational Problems studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Augmented Reality Headset measure: Progression through the ACLS clinical simulation demonstrated by NTS and TS measure: Demonstration of NTS during ACLS scenario measure: Evaluation of the AR system's usability measure: Exploration of perceptions, attitudes, and opinions of the AR simulation participants sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06326437 id: 1223 briefTitle: Dyadic Intervention for Psychological Distress of Patients With Colorectal Cancer and Their Spouses overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-07-01 date: 2024-03-22 date: 2024-03-22 name: Sun Yat-sen University class: OTHER briefSummary: The overall aim of the study is to evaluate the preliminary effect and feasibility of a dyadic intervention on mutuality, psychological strengths (i.e., illness cognition and dyadic coping), psychological distress, and QoL outcomes of patients with colorectal cancer and spouses. The colorectal cancer couples will be randomly allocated to the intervention group to receive a 6-week dyadic intervention, or to the control group to receive the usual care provided by the clinical team in the hospital. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: 6-week dyadic intervention measure: the Kessler psychological distress scale-10 measure: The Illness Cognition Questionnaire measure: Dyadic Coping Inventory measure: European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 measure: Locke-Wallace Marital Adjustment Scale sex: ALL minimumAge: 20 Years maximumAge: 59 Years stdAges: ADULT facility: The Sixth Affiliated Hospital of Sun Yat-sen University city: Guangzhou state: Guangdong zip: 510000 country: China name: Qian Sun role: CONTACT phone: +86 15616167998 email: sunq68@mail2.sysu.edu.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06326424 id: 2023H0085 briefTitle: Delirium Identification in Older Patients With Alzheimer's and Other Related Dementias In the Emergency Department acronym: DELIRIUM overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2025-03-01 date: 2025-03-01 date: 2024-03-22 date: 2024-03-22 name: Ohio State University class: OTHER briefSummary: Delirium is highly prevalent and very bad for patients with dementia. Delirium is a dangerous medical condition that occurs in 6-38% of older Emergency Department patients and 70% of ICU patients. A person who develops delirium in the ED or hospital has a 12 times higher odds of being newly diagnosed with dementia in the next year compared to a similar patient who does not become delirious. Delirium is especially dangerous for persons living with Alzheimer Disease and Related Dementias (AD/ADRD). Persons living with ADRD have an almost 50% chance of developing delirium in the hospital.

Clinicians are bad at recognizing delirium. A recent systematic review led by the Geriatric Emergency Care Applied Research network (NIH funded) found that current delirium screening tools are at most 64% sensitive, meaning that physicians can identify some phenotypes of delirium well, but cannot easily rule out delirium in acutely ill older patients.

The investigators propose integrating wrist biosensors into the emergency management of older adults with dementia. The investigators will monitor heart rate variability, movement, and electrodermal activity (electrical activity of at the level of the skin) to determine if an array of biosensors more sensitive to delirium than current verbal screening tools. conditions: Delirium conditions: Dementia conditions: Hospital Acquired Condition studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Empatica EmbracePlus measure: Proportion of participants who develop delirium measure: Intervention Acceptability measure: Biosensor data usability measure: Correlation of biosensor array data with clinical delirium sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: The Ohio State University Wexner Medical Center city: Columbus state: Ohio zip: 43210 country: United States lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06326411 id: NST-628-001 briefTitle: A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors acronym: NST-628 overallStatus: RECRUITING date: 2024-03 date: 2028-11 date: 2029-11 date: 2024-03-22 date: 2024-03-27 name: Nested Therapeutics, Inc class: INDUSTRY briefSummary: This is a two-part Phase 1, open label, multi-center, single arm, non-randomized, multiple dose, safety, pharmacokinetic (PK) and preliminary efficacy study of single agent NST-628 in adult patients with MAPK pathway mutated/dependent advanced solid tumors who have exhausted standard treatment options. conditions: Oncology conditions: MEK Mutation conditions: RAF Gene Mutation conditions: Ras (KRAS or NRAS) Gene Mutation conditions: Melanoma conditions: NSCLC conditions: Glioma conditions: Solid Tumor, Adult conditions: MAPK Pathway Gene Mutation studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 230 type: ESTIMATED name: NST-628 measure: Part A and B: Evaluate the safety of NST-628 in patients with advanced solid tumors measure: Part A: Determine the recommended dose for expansion of NST-628 measure: Part B: Evaluate objective tumor response rate measure: Part A: Evaluate objective tumor response rate measure: Part A and B: Evaluate progression free survival (PFS) measure: Part A and B: Evaluate overall survival (OS) measure: Part A and B: Characterize the pharmacokinetics of NST-628 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Scientia Clinical Research, Ltd status: RECRUITING city: Rand state: New South Wales zip: 2031 country: Australia name: Shiena Lemin role: CONTACT phone: +61 2 9382 5800 email: ethics@scientiaclinicalresearch.com.au name: Charlotte Lemech, MD role: PRINCIPAL_INVESTIGATOR lat: -35.60079 lon: 146.62354 facility: Southern Oncology Research Unit status: NOT_YET_RECRUITING city: Adelaide zip: 5042 country: Australia name: Meggan O'Riley role: CONTACT email: Meggan.ORiley@socru.org.au name: Ganessan Kichenadasse, MD role: PRINCIPAL_INVESTIGATOR lat: -34.92866 lon: 138.59863 hasResults: False

 nctId: NCT06326398 id: 3D moulage briefTitle: The Effect of Using 3D Printers and Moulage on Improving Stoma Care overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-01 date: 2024-10-01 date: 2024-03-22 date: 2024-03-25 name: Namik Kemal University class: OTHER name: TÜBİTAK briefSummary: When studies in the literature are examined, there are studies in which various methods are applied to students' stoma care knowledge and skills. Additionally, it is seen that there are studies using moulage or 3D printers as simulation applications in nursing education. However, there is no study on high-reality simulation application using 3D printer and moulage technique together.nIn this research, the effect of the stoma created with a 3D printer in a high-reality simulation on the stoma care knowledge and skills, satisfaction and self-confidence of nursing students will be examined by using the moulage technique. In addition, this application will be compared with nursing students' stoma care practices in the stoma model, which is classified as low-reality simulation. We think that our project will be unique in this field, as it uses current technological methods together in this planned research and is different from similar studies. conditions: Stoma Colostomy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: Stoma Care measure: Knowledge Level Evaluation Form Regarding Stoma Care measure: Stoma Care Skill Grading Key measure: Student Satisfaction and Self-Confidence Scale in Learning sex: ALL minimumAge: 18 Years maximumAge: 22 Years stdAges: ADULT hasResults: False

 nctId: NCT06326385 id: 53244021 briefTitle: Machine Learning Predictive Models for Sepsis Risk in ICU Patients With Intracerebral Hemorrhage overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-05-01 date: 2024-05-30 date: 2024-03-22 date: 2024-03-25 name: Xiangya Hospital of Central South University class: OTHER briefSummary: Patients with intracerebral hemorrhage (ICH) in the intensive care unit (ICU) are at heightened risk of developing sepsis, significantly increasing mortality and healthcare burden. Currently, there is a lack of effective tools for the early prediction of sepsis in ICH patients within the ICU. This study aims to develop a reliable predictive model using machine learning techniques to assist clinicians in the early identification of patients at high risk and to facilitate timely intervention.

The Medical Information Mart for Intensive Care (MIMIC) IV database (version 2.2) is an international online repository for critical care expertise. This database contains patient-related information collected from the ICUs of Beth Israel Deaconess Medical Center between 2008 and 2019. It includes a vast dataset of 299,712 hospital admissions and 73,181 intensive care unit patients.

The eICU Collaborative Research Database (eICU-CRD) comprises data from over 200,000 ICU admissions for 139,367 unique patients across 208 US hospitals between 2014 and 2015, providing a valuable resource for critical care research.

This study aims to establish and validate multiple machine learning models to predict the onset of sepsis in ICU patients with ICH and to identify the model with the optimal predictive performance. conditions: Intracerebral Hemorrhage conditions: Sepsis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1800 type: ESTIMATED name: no intervention measure: Occurrence of sepsis sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Le Zhang city: Changsha state: Hunan zip: 410008 country: China name: Le Zhang role: CONTACT phone: 13973187150 email: zlzdzlzd@csu.edu.cn name: Ye Li role: CONTACT phone: 19967131289 email: 17670516318@163.com lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06326372 id: Delirium briefTitle: The Effect of Intraoperative Hyperoxemia on Postoperative Delirium in Geriatric Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-06-20 date: 2024-07-01 date: 2024-03-22 date: 2024-03-28 name: Tepecik Training and Research Hospital class: OTHER briefSummary: Oxygen therapy is the most common treatment modality for patients with hypoxemia, but target values for normoxemia are not clearly defined. Therefore, iatrogenic hyperoxemia is a very common situation. Even though there are many side effects reported related to hyperoxemia and hyperoxemia is shown to be related to worse outcome than expected; clinicians still observe hyperoxemia frequently.

Oxygen reserve index (ORi™) (Masimo Corp., Irvine, USA) can guide clinicians in detection of hyperoxia. ORi is a parameter which can evaluate partial pressure of oxygen (PaO2) rating from 0 to 1. There are growing evidences in ORi that it might be helpful to reduce hyperoxia in general anesthesia. Continuous ORi monitoring can be used for detecting and preventing hyperoxia. The ability to perform FiO2 titration with ORi may be an appropriate monitoring management to prevent the harmful effects of hyperoxia.In this study, in patients who underwent major abdominal surgery; It was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia. conditions: Hyperoxia conditions: Delirium in Old Age studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: control name: ORi+SpO2 measure: Correlation of FiO2 and ORi value measure: Correlation of ORi and Delirium measure: Correlation of FiO2 and delirium sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Aykut Saritaş city: İ̇zmi̇r zip: 35640 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06326359 id: Soh-Med-24-02-03MD briefTitle: Autologous Stromal Vascular Fraction in Treatment of Male Androgenic Alopecia overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-10 date: 2026-10 date: 2024-03-22 date: 2024-03-22 name: Sohag University class: OTHER briefSummary: Evaluation of Safety and efficacy of autologous stromal vascular fraction derived from denovo versus platelet rich plasma enhanced donner site in treatment of male androgenic alopecia conditions: Androgenic Alopecia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: autologous stromal vascular fraction measure: hair density measure: hair shaft thickness sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06326346 id: AMC2401 briefTitle: GIST Oral Paclitaxel(Liporaxel) overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-03-31 date: 2027-03-31 date: 2024-03-22 date: 2024-03-27 name: Asan Medical Center class: OTHER briefSummary: The purpose of this study is to evaluate safety and efficacy of Liporaxel for patients with GIST who failed on prior standard treatments, including imatinib, sunitinib, and regorafenib, and with low P-glycoprotein expression. conditions: Gastrointestinal Stromal Tumors studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Liporaxel measure: 16 week disease control rate measure: Progression-free survival measure: Overall survival measure: Objective response rate measure: Adverse event assessed by NCI-CTCAE Version 5.0 sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Asan Medical Center, University of Ulsan College of Medicine city: Seoul state: Songpagu zip: 138-736 country: Korea, Republic of name: Min-Hee Ryu, MD, PhD role: CONTACT phone: 82-2-3010-5936 email: miniryu@amc.seoul.kr name: Hyung-Don Kim, MD, PhD role: CONTACT phone: 82-2-3010-0236 email: kimhdmd@amc.seoul.kr lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06326333 id: E.Kurul-E2-24-6176 briefTitle: Combination of Parasternal and Serratus Anterior Plane Block in Coronary Artery Bypass Graft Surgery overallStatus: COMPLETED date: 2024-02-07 date: 2024-03-27 date: 2024-04-18 date: 2024-03-22 date: 2024-04-22 name: Ankara City Hospital Bilkent class: OTHER briefSummary: Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in coronary artery bypass graft (CABG) surgery. If patients with high pain levels cannot breathe effectively, it may lead to atelectasis, cardiac ischemia, and arrhythmias. This prolongs the time it takes for patients to be discharged and increases the frequency of postoperative pulmonary complications and postoperative morbidity.

In addition to intravenous medications, various neuraxial and peripheral nerve blocks can be used in cardiac surgery. In recent years, neuraxial anesthesia has been avoided due to the use of intraoperative high-dose heparin. As an alternative, peripheral nerve blocks have recently gained popularity. Parasternal block (PSB) and serratus anterior plane block (SAPB) are very superficial and easy to reach. Recently, in the literature, the number of cases performed with these blocks under ultrasound guidance and the number of randomized controlled prospective studies have increased.

With this study, it was aimed to observe the analgesic effects on both the sternum and the drain site by applying PSB and SAPB applications simultaneously in the postoperative analgesia of CABG patients. conditions: Parasternal Block conditions: Serratus Anterior Plane Block conditions: Acute Pain conditions: Postoperative Analgesia conditions: Cardiac Surgery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ACTUAL name: Combined parasternal block and serratus anterior plane block measure: Pain Scores measure: Pain Scores measure: Pain Scores measure: Pain Scores measure: Pain Scores measure: Remifentanyl Consumption sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara City Hospital city: Çankaya state: Ankara zip: 06290 country: Turkey lat: 39.9179 lon: 32.86268 hasResults: False

 nctId: NCT06326320 id: E.Kurul-E2-24-6175 briefTitle: Combined SAPB in MICS overallStatus: RECRUITING date: 2024-02-07 date: 2024-05-07 date: 2024-05-17 date: 2024-03-22 date: 2024-03-25 name: Ankara City Hospital Bilkent class: OTHER briefSummary: Minimally invasive cardiac surgery (MICS) has begun to be performed frequently in recent years. Compared to sternotomy, MISC reduces the risk of mediastinitis, leaves a more aesthetic scar, facilitates postoperative rehabilitation, and shortens the hospital stay. MICS requires a thoracic incision in the right 4th or 5th intercostal space. This incision causes intense and long-lasting pain in the postoperative period. Pain is exacerbated by breathing movements, coughing, and respiratory physiotherapy.

Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in any type of cardiothoracic surgery. If patients with high pain levels cannot breathe effectively, it may lead to atelectasis, cardiac ischemia, and arrhythmias. This prolongs the time it takes for patients to be discharged and increases the frequency of postoperative pulmonary complications and postoperative morbidity.

In addition to intravenous medications, various neuraxial and peripheral nerve blocks can be used in cardiac surgery. In recent years, thoracic epidural analgesia has been avoided due to the use of intraoperative high-dose heparin. As an alternative, peripheral nerve blocks have recently gained popularity. SAPB is one of them. SAPB can be applied in three ways. While deep SAPB (DSAPB) is applied under the serratus anterior muscle, superficial SAPB (SSAPB) is applied above the serratus anterior muscle. Combined SAPB (CSAPB) is applied both below and above the serratus anterior muscle. These blocks can be performed with a single injection anywhere between the second and seventh ribs on the lateral chest wall.

In this study, the analgesic effects of ultrasound-guided CSAPB application in patients undergoing MICS will be evaluated. conditions: Serratus Anterior Plane Block conditions: Acute Pain conditions: Postoperative Analgesia conditions: Minimal Invasive Cardiac Surgery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Combined SAPB measure: Pain Scores measure: Pain Scores measure: Pain Scores measure: Pain Scores measure: Pain Scores measure: Remifentanyl Consumption sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara City Hospital status: RECRUITING city: Çankaya state: Ankara zip: 06290 country: Turkey name: Emine N Zengin, MD role: CONTACT phone: +905063370548 email: nilbavullu@gmail.com lat: 39.9179 lon: 32.86268 hasResults: False

 nctId: NCT06326307 id: 247-05-21 briefTitle: Effectiveness of Puppet Modeling Technique on Children Undergoing Stressful Dental Procedures overallStatus: COMPLETED date: 2023-01-01 date: 2023-12-01 date: 2023-12-01 date: 2024-03-22 date: 2024-03-22 name: King Abdulaziz University class: OTHER briefSummary: The goal of this RCT is to compare puppet modeling technique vs tell show and do on children undergoing stressful dental procedures'

* The main question\[s\] it aims to answer are:

  1. To compare the effect of puppet modeling vs tell show and do on the cooperation of children during the administration of local anesthesia.
  2. To compare the effect of puppet modeling vs tell show and do on the anxiety level of children during the administration of local anesthesia.

type of study: clinical trial participant population/health conditions: Healthy

In this randomized crossover clinical trial, study subjects were randomly allocated into two groups:

* Group I : Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD)
* Group II : Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit, 2 weeks later.(TSD-P) conditions: Behavioral Guidance in Pediatric Dentistry studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: * Group I : Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD)
* Group II: Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit, 2 weeks later.(TSD-P) primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Two evaluators, who are blinded to the experimented techniques, watched recorded videos of both groups separately and gave their behavior assessment. whoMasked: OUTCOMES_ASSESSOR count: 41 type: ACTUAL name: Tell Show and Do Guidance name: Puppet Guidance measure: Heart rate measure: Facial Image Scale measure: Vehnam Anxiety Rating Scale measure: Frankl behavior rating scale measure: FLACC Pain scale measure: Venham Scale of Dental behavior sex: ALL minimumAge: 3 Years maximumAge: 8 Years stdAges: CHILD facility: King Abulaziz university dental hospital city: Jeddah state: Makkah zip: 21589 country: Saudi Arabia lat: 21.54238 lon: 39.19797 hasResults: False

 nctId: NCT06326294 id: 727/CNBS/23 briefTitle: Assessment of the Effectiveness of TA Versus LEEP for Cervical Cancer Risk Reduction in WLHIV in Mozambique overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-09 date: 2027-12 date: 2024-03-22 date: 2024-03-22 name: Instituto Nacional de Saúde, Mozambique class: OTHER_GOV name: M.D. Anderson Cancer Center briefSummary: Given that WLWH are more likely to develop persistent HPV infection and CC, effective screening and the management and treatment of pre-cancerous cervical abnormalities is critical to decrease the global burden of cervical cancer. The vast majority of WLWH live in SSA, where resources are more constrained. Therefore, simple, affordable, and effective tools are needed for the prevention of cervical cancer in SSA. In this setting, the best method for treatment of screen-positive WLWH has not been determined. The proposed study will compare the effectiveness of TA vs. LEEP, for treating precursor lesions (CIN 2/3) and HPV infection in WLWH, identify the determinants of treatment failure, and develop a strategy to predict patients in whom treatment is likely to fail so that alternative treatments can be provided. Moreover, local evidence of the optimal method of treatments is necessary to inform health policy and promote adherence. conditions: HIV Infections conditions: HPV Infection conditions: CIN 2/3 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: To compare TA, an ablative cervical treatment modality, and LEEP, an excisional cervical treatment modality, in screen-positive WLWH patients, for eradication of hrHPV and effectiveness of treating biopsy-confirmed CIN 2/3. primaryPurpose: TREATMENT masking: NONE count: 4844 type: ESTIMATED name: Thermal ablation name: LOOP ELECTROSURGICAL EXCISION PROCEDURE measure: Comparison of treatment success rates for biopsy-confirmed CIN 2/3: Thermoablation (TA) vs. Loop Electrosurgical Excision Procedure (LEEP) sex: FEMALE minimumAge: 25 Years maximumAge: 49 Years stdAges: ADULT facility: INSMozambique city: Maputo country: Mozambique lat: -25.96553 lon: 32.58322 hasResults: False

 nctId: NCT06326281 id: ACHBILKENT-ANEST-BK-01 briefTitle: Postoperative Pain Management in Laparoscopic Cholecystectomies overallStatus: COMPLETED date: 2023-07-01 date: 2024-02-22 date: 2024-02-28 date: 2024-03-22 date: 2024-03-22 name: Ankara City Hospital Bilkent class: OTHER briefSummary: This study is to demonstrate the effectiveness of external oblique intercostal plane block, a new block method, in the treatment of postoperative pain occurring after laparoscopic cholecystectomy operations, which are frequently and widely performed today.

It aims to add new applications to multimodal analgesia methods, which provide the greatest contribution to the early recovery process after surgery, and to contribute to the early recovery process by increasing patient satisfaction. conditions: Cholecystitis/Cholelithiasis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Evaluation of postoperative pain in 4 groups in laparoscopic cholecystectomy with control group primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Patients were not told which method would be used The person evaluating the patients did not know which method was applied to which patient. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 100 type: ACTUAL name: external oblique intercostal plane block group name: oblique subcostal TAP block group name: Local anesthetic infiltration group name: control group measure: Visual Analogue Scale Score sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Bılkent City Hospital city: Ankara zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06326268 id: 2023-019 id: 2023-A02133-42 type: OTHER domain: ID-RCB Number briefTitle: Interest of Light Therapy in Hematology - The PHOTO-TREAT Study acronym: PHOTO-TREAT overallStatus: RECRUITING date: 2024-04-17 date: 2025-09-17 date: 2025-09-17 date: 2024-03-22 date: 2024-04-22 name: Institut de cancérologie Strasbourg Europe class: OTHER briefSummary: Chemo-induced mucositis is a common complication in patients treated for hematologic malignancies. They can manifest itself as a simple local irritation with erythema and inflammation but can also progress to erosions and ulcerations of the entire oral mucosa and are also responsible for an increased risk of infection in these immunocompromised patients.

The only therapies currently offered are local care and intravenous analgesics. Studies in pediatric hematology show the effectiveness of prevention and low-dose laser treatment in chemo-induced mucositis, both in terms of reducing the number of mucositis developed but also in terms of reducing the grade of mucositis. This currently results in a recommendation for the use of photobiomodulation by international bodies such as ESMO (European Society for Medical Oncology). conditions: Leukemia, Myeloid, Acute conditions: Lymphoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: Phototherapy system CareMin650TM measure: Evaluate the impact of Photobiomodulation (PBM) therapy in the management of chemo-induced mucositis in terms of prevalence of mucositis measure: Evaluate the impact of PBM in the management of chemo-induced mucositis in terms of reduction in analgesic consumption. measure: Evaluate the impact of PBM in terms of infection by bacterial translocation risk reduction. measure: Evaluate the impact of PBM in terms of reduction of the use of artificial feeding. measure: Evaluate the impact of PBM in terms of reduction of the length of hospital stay. measure: Evaluate the impact of PBM in terms of reduction of the number of transfusions. measure: Evaluate the impact of PBM in terms of pain reduction measure: Evaluate the impact of PBM on patient's satisfaction regarding pain management during hospital stay sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institut de cancérologie Strasbourg Europe status: RECRUITING city: Strasbourg zip: 67033 country: France role: CONTACT phone: (0)3 68 33 95 23 phoneExt: +33 email: promotion-rc@icans.eu name: Anne ZILLIOX, MD role: PRINCIPAL_INVESTIGATOR lat: 48.58392 lon: 7.74553 hasResults: False

 nctId: NCT06326255 id: LYASD briefTitle: Feasibility and Acceptability of Laughter Yoga in Children With Autism Spectrum Disorder and Their Parents overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-10-01 date: 2025-12-31 date: 2024-03-22 date: 2024-03-22 name: The Hong Kong Polytechnic University class: OTHER briefSummary: This is a pilot randomised controlled trial to explore the acceptability and feasibility of laughter yoga about anxiety and depression reduction in children with ASD and parenting stress reduction for their parents. Hypotheses of this study include:

1. Laughter yoga is acceptable to children with ASD and their parents.
2. Laughter yoga is feasible for anxiety and depression reduction in children with ASD and parenting stress reduction in their parents.
3. Participants in the experimental group will have significantly more reduction in depression, anxiety and parental stress than those in the wait-list-control group. conditions: Autism Spectrum Disorder conditions: Parenting Stress conditions: Depression conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 66 type: ESTIMATED name: laughter yoga measure: Response rate measure: Attrition rate measure: Attendance rate measure: Perception on laughter yoga measure: Difficulties in laughter yoga measure: Safety issues measure: Depression measure: Anxiety measure: Parenting Stress measure: Child-parent Relationships sex: ALL minimumAge: 8 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The Hong Kong Polytechnic University city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06326242 id: IEO 1648 briefTitle: What Unmet Need for the Patients?A Focus on the Social Determinants of Health in Phase 1 Clinical Trials overallStatus: RECRUITING date: 2023-03-27 date: 2024-12-31 date: 2024-12-31 date: 2024-03-22 date: 2024-03-22 name: European Institute of Oncology class: OTHER briefSummary: An observational prospective study of patients enrolled and treated with experimental drugs in Phase I studies. conditions: Solid Tumor studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Solid Tumor measure: The geographical accessibility of patients attending the Phase 1 facility of the European Institute of Oncology (IEO). measure: The characterization of enrolled patients involves assessing their participation in clinical trials measure: The characterization of enrolled patients based on therapeutic compliance. measure: The protocol prescriptions in relation to socioeconomic and geographical determinants. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of oncology status: RECRUITING city: Milano zip: 20141 country: Italy name: Teresa Profeta role: CONTACT phone: +390294372561 lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06326229 id: CEIm 3096 briefTitle: Clinical Validation of Musculoskeletal ICF Core Set in Primary Care Physiotherapy overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-01-31 date: 2025-09-26 date: 2024-03-22 date: 2024-04-05 name: University of Valladolid class: OTHER name: Castilla-León Health Service briefSummary: The aim of this observational study is to validate the content of a tailored ICF core set for the management of musculoskeletal conditions in primary care physiotherapy services.

The main question it aims to answer is:

- Are the ICF entities included in the ICF Core Set under evaluation useful from a clinical point of view?

Participants will evaluate the relevance of each ICF entity included in the ICF core set according to their musculoskeletal condition. conditions: Musculoskeletal Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 385 type: ESTIMATED name: ICF entities assessment measure: ICF core set for post-acute musculoskeletal conditions (adapted version for primary care physiotherapy services) measure: Sociodemographic data of the sample sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ólvega Primary Care Physiotherapy service city: Ólvega state: Soria zip: 42110 country: Spain name: Héctor Hernández Lázaro, PhD role: CONTACT phone: +34976645480 phoneExt: 38229 email: hhernandezl@saludcastillayleon.es lat: 41.77901 lon: -1.98391 hasResults: False

 nctId: NCT06326216 id: 19-011292 id: NCI-2023-05221 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 19-011292 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer overallStatus: RECRUITING date: 2020-06-10 date: 2025-07-01 date: 2025-07-01 date: 2024-03-22 date: 2024-03-22 name: Mayo Clinic class: OTHER briefSummary: This study is being done to determine whether levels of prostate cancer derived extracellular vesicles from blood and urine specimens correlate with response to primary local treatment (surgery) in prostate cancer. conditions: Prostate Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Non-Interventional Study measure: Levels of prostate cancer-derived extracellular vesicles (EVs) - radical prostatectomy measure: Levels of prostate cancer-derived extracellular vesicles (EVs) - negative controls measure: Correlation between prostate specific antigen (PSA) levels and prostate cancer-derived EVs measure: Prostate cancer-derived EV levels sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Eugene D. Kwon, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06326203 id: UPECLIN-MB-8 briefTitle: Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb Ischemia overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-07-01 date: 2027-12-31 date: 2024-03-22 date: 2024-04-10 name: UPECLIN HC FM Botucatu Unesp class: OTHER name: Conselho Nacional de Desenvolvimento Científico e Tecnológico briefSummary: Peripheral arterial disease (PAD) can progress to critical limb ischemia (CLI) of the affected lower limb, characterized by pain at rest, ulcerations or gangrene, with a high risk of amputation. In this phase, the best treatment is arterial limb revascularization, but this is not always possible or even effective for promoting pain relief, healing of ulcers or preventing amputations, in addition to the high socioeconomic cost caused by the disease. Recent advances in cell therapy represent a promising supporting alternative for the treatment of PAD in cases where conventional alternatives have run out. Objective: To evaluate the safety and efficacy of cell therapy with expanded autologous mesenchymal stem cells in the treatment of patients with PAD with CLI and chronic arterial ulcers. Methods: An open randomized clinical study will be performed with 2 groups of 20 patients with CLI: in group 1, a fragment of abdominal fat tissue (10g) will be collected to obtain mesenchymal stem cells, which will be expanded and applied using subcutaneous perilesional injection in the affected lower limb, in addition to the application in the form of a personalized curative biological on the wounds. Group 2 will receive conventional treatment with a Hydrogel dressing with essential fatty acids. Periodic clinical evaluations, complementary exams and photographic record will be carried out. The main outcome of effectiveness will be partial or total wound healing. Safety outcomes will be monitored for infections, gangrene, amputations and deaths. Participants will be monitored for 120 days. Major amputation cases will not be included. An independent external evaluator and blind to the groups will evaluate the results. It is an innovative procedure with high impact and financial return for SUS, in view of the high prevalence of the disease and the high socioeconomic impact of the disease when it progresses to limb amputation. conditions: Peripheral Arterial Disease conditions: Leg Ulcer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: CELULAS TRONCO name: CONVENTIONAL DRESSING measure: Major Amputation measure: Ulcer Healing sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06326190 id: EORTC-2334-BTG briefTitle: 177Lu-DOTATATE for Recurrent Meningioma acronym: LUMEN-1 overallStatus: NOT_YET_RECRUITING date: 2024-11-06 date: 2027-04-14 date: 2028-12-22 date: 2024-03-22 date: 2024-03-22 name: European Organisation for Research and Treatment of Cancer - EORTC class: NETWORK name: Novartis briefSummary: Novel treatments are urgently needed for meningiomas progressing after local therapies (surgery, radiotherapy). So far, no effective systemic therapies are known in this situation. The LUMEN-1 trial will investigate in a prospective randomized trial the efficacy of the precision medicine "theranostic" concept of combining diagnostic patient selection using PET-based molecular imaging and target-specific therapeutic intervention using a systemically administered radioligand.

The rationale for the LUMEN-1 trial is based on the following: (a) high somatostatin receptor (SSTR) expression in meningiomas, (b) wide-spread availability of clinically established SSTR-PET imaging, (c) proven efficacy of SSTR-targeting radioligand therapy using \[177Lu\]Lu-DOTATATE in another tumor type (neuroendocrine tumors), and (d) promising experiences with \[177Lu\]Lu-DOTATATE therapy in compassionate use applications and retrospective case series and interim results from one ongoing uncontrolled prospective trial in meningiomas. LUMEN-1 is the first randomized clinical trial to investigate \[177Lu\]Lu-DOTATATE therapy in refractory meningioma and may open new avenues for treatment and research in this area. conditions: Recurrent Meningioma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 135 type: ESTIMATED name: Local standard of Care name: 177Lu-DOTATATE measure: Progression Free Survival (PFS) measure: Overall Survival (OS) measure: Radiological response rate measure: Radiological response rate measure: The magnitude of change in Health-related quality of life (HRQoL) measure: The magnitude of change in Health-related quality of life (HRQoL) measure: The magnitude of change in Health-related quality of life (HRQoL) measure: Neurological function (NANO scale) measure: Toxicity According to CTCAE Version 5.0 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06326177 id: Yeditepe U - Poyraz Tuncer briefTitle: Investigating Association Between Spine, Scapular, Shoulder and Core in Swimmers overallStatus: ENROLLING_BY_INVITATION date: 2024-06-15 date: 2024-07-01 date: 2024-09-01 date: 2024-03-22 date: 2024-03-27 name: Yeditepe University class: OTHER briefSummary: The aim of this observational study is to investigate relationship between cervical, thoracic, lumbar and thoracolumbar spine posture, spine movement, isometric and eccentric shoulder strength, scapular dyskinesis and core muscle endurance in healthy competitive young swimmers in comparison with healthy recreational swimmers. The main question is whether spine posture affects spine movement, shoulder strength, scapular dyskinesia and core endurance. Participants will asked to complete a warm up period, after that spine posture, spine movement, scapular dyskinesia, shoulder strength and core endurance will be assessed by examiner. Researchers will compare competitive swimmer group and recreational swimmer group. Additionally correlation between spine posture, spine movement, scapular dyskinesia, shoulder strength and core muscle endurance will be investigated in competitive swimmer group. Aim of the study is to determine whether posture have any effect upon these parameters. conditions: Postural Kyphosis conditions: Postural Lordosis conditions: Movement, Abnormal conditions: Spine Injury conditions: Cervical Lordosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 44 type: ESTIMATED name: Spine Posture Assessment name: Spine Movement Assessment name: Core Muscle Endurance Assessment name: Scapular Dyskinesia name: Shoulder Strength measure: Spinal Posture measure: Cervical Movement measure: Thoracic Movement measure: Lumbar Movement measure: Thoracolumbar Movement measure: Anterior Core Musculature Assessment measure: Lateral Core Musculature Assessment measure: Posterior Core Musculature Assessment measure: Core Musculature Ratio Assessment measure: Shoulder Strength Assessment measure: Shoulder Strength Ratio Assessment measure: Scapular Dyskinesia sex: ALL minimumAge: 12 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT facility: PT Academy city: Istanbul state: Kadıköy zip: 34744 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06326164 id: sample briefTitle: Effect of Kinesio-taping of Lower Limbs overallStatus: RECRUITING date: 2024-02-15 date: 2024-06-15 date: 2024-07-18 date: 2024-03-22 date: 2024-03-22 name: Kafrelsheikh University class: OTHER briefSummary: The goal of this clinical trail is to test if kinesio-taping on lower limbs has an effect on balance and gait in children with diplegic cerebral palsy. Children in study group will have designed physiotherapy for gait and balance, the control group will have designed physiotherapy in addition to kinesio-taping on both lower limbs. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: kinesio-taping. name: A designed physiotherapy program. measure: Change in gait. measure: Change in balance. sex: ALL minimumAge: 6 Years maximumAge: 10 Years stdAges: CHILD facility: Asmaa Mohamed Khalil Sedeek status: RECRUITING city: Kafr Ash Shaykh country: Egypt name: asmaa M khalil role: CONTACT phone: 01101011588 email: asmaakhalil011010@gmail.com lat: 31.11174 lon: 30.93991 hasResults: False

 nctId: NCT06326151 id: UMAPS-UDATO briefTitle: Interdisciplinary Psychoeducational Intervention Programme for Caregivers of Dependent Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-09-01 date: 2025-12-31 date: 2024-03-22 date: 2024-03-22 name: University of Salamanca class: OTHER briefSummary: Background: Caring for an older dependent adult with cognitive impairment can have negative consequences for the family caregiver. Interdisciplinary interventions are necessary to address their needs jointly and comprehensively. While attempts have been made to improve their situation from different disciplines in isolation, a collaborative approach is required to ensure the best possible outcome.

Methods: A parallel, randomized, controlled clinical trial with two arms will be conducted at the Occupational Therapy Teaching and Care Unit (UDATO) and the Municipal Psychosocial Support Unit for the Elderly (UMAPS), both of which belong to the University of Salamanca and are in agreement with the City Council of Salamanca, Spain. The trial will also be conducted at the University Care Centre of Salamanca (CAUSA). People aged 60 years or older will be recruited as family caregivers of dependent older adults with cognitive impairment in a chronic situation. Participants will be divided into two groups: the intervention group (IG) will carry out an interdisciplinary psychoeducational programme from the perspective of psychology and occupational therapy, and the control group (CG) will carry out a controlled follow-up. Participants will complete 12 sessions over a period of 3 months, followed by three monthly reinforcement sessions after the intervention. At the beginning and end of the intervention, participants will be assessed and socio-demographic data will be collected along with the following scales: the Spanish version of the Caregiver Burden Interview (CBI), the Spanish version of the Center for Epidemiologic Studies-Depression Scale (CES-D), the Psychosocial Support Questionnaire adaptation (PSQ), the General Health Questionnaire (GHQ), the World Health Organization Quality of Life Assessment - AGE (WHOQOL-AGE) and the Bayer-Activities of Daily Living Scale (B-ADL).

Discussion: The objective of this study is to enhance conventional clinical practice for family caregivers of dependent older adults. This will be achieved through an interdisciplinary psychoeducational intervention that aims to reduce overload and depressive symptomatology, increase social support, improve health and perceived quality of life, and enhance understanding of the syndrome/illness. The intervention will also focus on managing difficult situations associated with day-to-day caregiving, managing emotions and associated erroneous beliefs, and promoting self-care. Additionally, the study aims to improve the functionality of the cared-for person. conditions: Dependent Older People conditions: Family Caregiver conditions: Interdisciplinary conditions: Intervention conditions: Occupational Therapy conditions: Psychoeducational conditions: Psychology studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The work of sequencing, randomisation, recruitment and allocation of the trial sample will be carried out by research staff who are not involved in the assessments or interventions of each group, thus avoiding any potential bias in the trial.

Participants will also be blinded and will not know which group they have been allocated to and therefore which intervention they will receive. In order to minimise any contamination between groups, the assessment process will be carried out by external research staff who will perform the measurements and who have been previously trained and educated to avoid subjective bias in the process, as they will be unaware of the intervention group to which they have been assigned, thus masking the blinded assessment by third parties in the clinical trial. In addition, the researchers responsible for the statistical analysis of the trial will be blinded in order to increase the rigour of the trial process and thus the scientific quality. whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Interdisciplinary Psychoeducational Programme name: Health Education Programme measure: Mini Mental State Examination (MMSE) measure: Barthel Index measure: Caregiver Burden Interview measure: Centre for Epidemiological Studies Depression Scale measure: Adaptation of the Psychosocial Support Questionnaire measure: General Health Questionnaire measure: World Health Organization Assessment of Quality of Life - AGE (WHOQOL-AGE) measure: The Bayer-Activities of Daily Living Scale (B-ADL) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eduardo Jose Fernandez Rodriguez city: Salamanca state: Castilla Y Leon zip: 37002 country: Spain name: Eduardo PhD Fernandez, PhD role: CONTACT phone: 923294500 email: edujfr@usal.es lat: 40.96882 lon: -5.66388 hasResults: False

 nctId: NCT06326138 id: 22121 briefTitle: Pharmacokinetics and Pharmacodynamics of Edoxaban Before and After Bariatric Surgery acronym: EXPOSE overallStatus: WITHDRAWN date: 2024-03-11 date: 2024-03-11 date: 2024-03-11 date: 2024-03-22 date: 2024-03-22 name: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval class: OTHER briefSummary: The study will be conducted at a single site in the Canada, Quebec. Participants will be recruited from the bariatric surgery clinic and will be required to be either, waiting for sleeve gastrectomy surgery (n=12, restrictive bariatric surgery, Group 1) or Roux-en-Y gastric bypass (n=12, mixed bariatric surgery, Group 1), or had underwent Roux-en-Y gastric bypass 12 ± 3 months ago (n=12, Group 2).

Participants in Group 1, edoxaban pharmacokinetic and pharmacodynamics will be evaluated before and 48 ± 5 hours after bariatric surgery (sleeve gastrectomy and Roux-en-Y gastric bypass). Participants in Group 2, edoxaban pharmacokinetic and pharmacodynamics will be evaluated only once, at 12 ± 3 months following their Roux-en-Y gastric bypass.

All participants will be received single oral doses of 60 mg edoxaban at each pharmacokinetic and pharmacodynamics evaluation. conditions: Bariatric Surgery Candidate studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group 1: 12 patients waiting for a sleeve gastrectomy surgery and 12 patients waiting for a Roux-en-Y gastric bypass surgery.

Group 2: 12 patients 12 months after Roux-en-Y gastric bypass surgery. primaryPurpose: OTHER masking: NONE count: 0 type: ACTUAL name: Edoxaban Pharmacokinetics and Pharmacodynamics measure: Pharmacokinetics edoxaban parameter measure: Pharmacokinetics edoxaban parameter measure: Pharmacokinetics edoxaban parameter measure: Pharmacokinetics edoxaban parameter measure: Pharmacodynamics edoxaban parameter measure: Pharmacodynamics edoxaban parameter measure: Pharmacodynamics edoxaban parameter sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06326125 id: SherzadSH briefTitle: Pharmacology and Non-pharmacology Approaches in Reducing Children's Pain and Fear During Painful Procedures overallStatus: ENROLLING_BY_INVITATION date: 2023-12-15 date: 2024-04-10 date: 2024-04-10 date: 2024-03-22 date: 2024-03-28 name: Uppsala University class: OTHER briefSummary: This study Will contribute in the knowledge of pediatric nurses during painful procedures such venipuncture conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: TICK-B name: TKTX-Cream name: TICK-B and TKTX-C measure: severity of Pain measure: Fear sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Sherzad Khudeida Suleman city: Duhok state: Erbil zip: 42012 country: Iraq lat: 36.86709 lon: 42.98845 hasResults: False

 nctId: NCT06326112 id: 4588 briefTitle: Role of Active Deresuscitation After Resuscitation: acronym: RADAR-Canada overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-03-31 date: 2025-06-30 date: 2024-03-22 date: 2024-03-22 name: Unity Health Toronto class: OTHER name: Canadian Institutes of Health Research (CIHR) briefSummary: The RADAR-Canada trial is a pilot RCT undertaken to assess the acceptability of, compliance with, and biologic consequences of a deresuscitation protocol designed to expedite the removal of excess interstitial fluid in patients who remain in a positive fluid balance following admission to an intensive care unit (ICU). conditions: Fluid Overload conditions: Critical Illness conditions: Sepsis conditions: ARDS conditions: Trauma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: RADAR-Canada is a parallel group CT in which study participants are randomized in a 1:1 ratio to protocolized deresuscitation or usual care primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Masking of the health care team will not be feasible as they must administer the intervention whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Furosemide Injection name: Metolazone Tablets measure: Efficacy: Mean cumulative fluid balance measure: Compliance with deresuscitation protocol measure: Acceptability of protocol measure: All cause mortality measure: New onset organ dysfunction measure: Organ support-free days measure: Inflammatory and renal biomarkers - change from baseline values sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Unity Health Toronto city: Toronto state: Ontario zip: M5B 1W8 country: Canada name: John C Marshall, MD role: CONTACT phone: 4168645225 email: john.marshall@unityhealth.to lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06326099 id: R34AA030655 type: NIH link: https://reporter.nih.gov/quickSearch/R34AA030655 briefTitle: Brief Binge Eating and Drinking Online Intervention overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-04-30 date: 2024-03-22 date: 2024-03-22 name: University of Southern California class: OTHER briefSummary: This pilot project targets both binge drinking and binge eating behavior in college students through a mobile-based online program that provides students with evidence-based intervention material designed to reduce the incidence of both behaviors and encourage students to seek more formal in-person counseling. conditions: Binge Eating conditions: Binge Drinking studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 300 type: ESTIMATED name: Brief Online Binge Eating and Drinking Intervention measure: Frequency of past 28-day binge drinking measure: Frequency of past 28-day binge eating measure: Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ) measure: Mental Health/Substance Use Disorder Treatment History Inventory sex: ALL minimumAge: 18 Years maximumAge: 24 Years stdAges: ADULT hasResults: False

 nctId: NCT06326086 id: REC.65-080-7-1 briefTitle: Differences in Rate of Decline in CT-defined Skeletal Muscle Mass and Physical Performance in Patients With Advanced Non-small Cell Lung Cancer Receiving Chemotherapy and Targeted Therapy/Immunotherapy, Before and After Treatment. overallStatus: RECRUITING date: 2022-08-01 date: 2024-08-01 date: 2024-08-01 date: 2024-03-22 date: 2024-03-22 name: Prince of Songkla University class: OTHER briefSummary: Lung cancer is a common disease leading to 18 % of cancer deaths worldwide. Despite various improvement in treatment, there still remains low 5-year survival rate of 10-20 % in advanced lung cancer patients. Skeletal muscle mass and physical performance have been shown to effect overall survival and prognosis in lung cancer. This research focuses on effects of different treatment of lung cancer such as chemotherapy, targeted therapy and immunotherapy on skeletal muscle mass and physical performance. conditions: Advanced Lung Cancer conditions: Sarcopenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 240 type: ESTIMATED name: Chemotherapy drug name: Targeted Agent name: Immunotherapy measure: To determine the differences in the rate of decline in CT defined skeletal muscle index at L3 vertebra and physical performance in advanced NSCLC patients receiving chemotherapy and targeted therapy/ immunotherapy, before and after treatment. measure: To determine validity of gender based cut off for CT-defined skeletal muscle index at L3 lumbar vertebra (L3SMI) based on recommendation of JSH/AWGS in Thai population. measure: 2. To determine baseline association between CT-defined skeletal muscle index at L3 lumbar vertebra (L3SMI) and physical performance using SPPB in advanced NSCLC patients. measure: 4. To determine differences in rate decline in skeletal muscle mass using CT-defined skeletal muscle index at L3 lumbar vertebra (L3SMI) in patients receiving first line chemotherapy (CMT) and other line chemotherapy (OCMT). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prince of Songkla University status: RECRUITING city: Hat Yai state: Songkla zip: 90110 country: Thailand lat: 7.00836 lon: 100.47668 hasResults: False

 nctId: NCT06326073 id: OMUKAEK2019/324 briefTitle: Interaction Between Smoking, GCF Periostin, IL17A, IL17E and Non-surgical Periodontal Therapy overallStatus: COMPLETED date: 2019-07-01 date: 2021-02-01 date: 2021-07-01 date: 2024-03-22 date: 2024-03-22 name: Ondokuz Mayıs University class: OTHER briefSummary: It was aimed to evaluate the changes in the levels of Periostin, IL-17A and IL-17E cytokines in the gingival crevicular fluid (GCF) of periodontitis patients which non-surgical (Phase I) periodontal treatment applied to and their interactions with smoking. The study included systemic healthy smokers(SP)(n:11) and non-smokers(P)(n:11) with periodontitis, smokers (SS)(n:11) and non-smokers(S)(n:11) with periodontal healthy individuals Phase I periodontal treatment was applied to the groups with periodontitis. Before treatment (day 0), clinical measurements evaluating periodontal status were recorded and GCF samples were collected. GCF samples were collected from the same tooth regions on the 15th and 30th days after treatment and clinical measurements were repeated. GCF Periostin, IL-17A and IL-17E levels were determined by ELISA method. All data were evaluated statistically. conditions: Periodontitis conditions: Smoking studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study included systemic healthy smokers(SP)(n:11) and non-smokers(P)(n:11) with periodontitis, smokers (SH)(n:11) and non-smokers(H)(n:11) with periodontal healthy individuals primaryPurpose: DIAGNOSTIC masking: NONE count: 44 type: ACTUAL name: Non Surgical Periodontal Treatment measure: Evaluation of Periostin levels measure: Evaluation of IL-17A levels measure: Evaluation of IL-17E levels measure: Interaction Between Smoking and GCF Periostin, IL17A, IL17E levels sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ondokuz Mayıs University Faculty of Dentistry Department of Periodontology city: Samsun zip: 55270 country: Turkey lat: 41.27976 lon: 36.3361 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-16 uploadDate: 2024-03-16T11:54 filename: Prot_SAP_000.pdf size: 206405 hasResults: False

 nctId: NCT06326060 id: NN9541-5015 id: U1111-1291-9210 type: OTHER domain: World Health Organization (WHO) id: jRCT2051230198 type: REGISTRY domain: JRCT briefTitle: A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight overallStatus: RECRUITING date: 2024-03-18 date: 2024-11-25 date: 2025-05-05 date: 2024-03-22 date: 2024-04-18 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study will look at how a new medicine called NNC0519-0130 helps people with excess body weight lose weight. The study will test up to 6 different doses of NNC0519-0130. Participants will take 1-2 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 42 weeks. conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Sponsor staff involved in the clinical trial is masked according to company standard procedures. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 343 type: ESTIMATED name: NNC0519-0130 name: Placebo name: Tirzepatide measure: Relative change in body weight measure: Change in body weight measure: Achievement of greater than equal to (≥) 5% weight reduction measure: Achievement of ≥ 10% weight reduction measure: Achievement of ≥ 15% weight reduction measure: Achievement of ≥ 20% weight reduction measure: Change in body mass index (BMI) measure: Change in waist circumference measure: Change in glycated hemoglobin (HbA1c) measure: Change in fasting plasma glucose (FPG) measure: Change in systolic blood pressure (SBP) measure: Change in high sensitivity C-Reactive protein (hsCRP) measure: Change in total cholesterol measure: Change in high-density lipoprotein (HDL) cholesterol measure: Change in low-density lipoprotein (LDL) cholesterol measure: Change in triglycerides measure: Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score measure: Change in IWQOL-Lite-CT Psychosocial composite score measure: Change in IWQOL-Lite-CT Physical Function score measure: Change in IWQOL-Lite-CT Total score measure: Number of adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centricity Research-Arizona status: WITHDRAWN city: Mesa state: Arizona zip: 85206 country: United States lat: 33.42227 lon: -111.82264 facility: Arkansas Clinical Research status: WITHDRAWN city: Little Rock state: Arkansas zip: 72205 country: United States lat: 34.74648 lon: -92.28959 facility: Unity Health-Searcy Medical Center status: RECRUITING city: Searcy state: Arkansas zip: 72143 country: United States lat: 35.25064 lon: -91.73625 facility: FDRC status: RECRUITING city: Costa Mesa state: California zip: 92627 country: United States lat: 33.64113 lon: -117.91867 facility: Diablo Clinical Research, Inc. status: RECRUITING city: Walnut Creek state: California zip: 94598 country: United States lat: 37.90631 lon: -122.06496 facility: Univ of Colorado at Denver status: WITHDRAWN city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 facility: Nature Coast Clinical Research status: RECRUITING city: Crystal River state: Florida zip: 34429 country: United States lat: 28.90248 lon: -82.5926 facility: Northeast Research Institute status: RECRUITING city: Fleming Island state: Florida zip: 32003 country: United States lat: 30.0933 lon: -81.71898 facility: Jacksonville Ctr For Clin Res status: RECRUITING city: Jacksonville state: Florida zip: 32216 country: United States lat: 30.33218 lon: -81.65565 facility: Cedar-Crosse Research Center status: RECRUITING city: Chicago state: Illinois zip: 60607 country: United States lat: 41.85003 lon: -87.65005 facility: Midwest Inst For Clin Res status: RECRUITING city: Indianapolis state: Indiana zip: 46260 country: United States lat: 39.76838 lon: -86.15804 facility: Velocity Clin. Res Valparaiso status: RECRUITING city: Valparaiso state: Indiana zip: 46383 country: United States lat: 41.47309 lon: -87.06114 facility: L-MARC Research Center status: RECRUITING city: Louisville state: Kentucky zip: 40213 country: United States lat: 38.25424 lon: -85.75941 facility: Centennial Medical Group status: RECRUITING city: Columbia state: Maryland zip: 21045 country: United States lat: 39.24038 lon: -76.83942 facility: StudyMetrix Research LLC status: RECRUITING city: Saint Peters state: Missouri zip: 63303 country: United States lat: 38.80033 lon: -90.62651 facility: NYU Bariatric Surgical Ctr status: NOT_YET_RECRUITING city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 facility: Medication Mgmnt, LLC_Grnsboro status: RECRUITING city: Greensboro state: North Carolina zip: 27405 country: United States lat: 36.07264 lon: -79.79198 facility: PharmQuest Life Sciences LLC status: RECRUITING city: Greensboro state: North Carolina zip: 27408 country: United States lat: 36.07264 lon: -79.79198 facility: Physicians East Endocrinology status: RECRUITING city: Greenville state: North Carolina zip: 27834 country: United States lat: 35.61266 lon: -77.36635 facility: Piedmont Healthcare status: RECRUITING city: Statesville state: North Carolina zip: 28625 country: United States lat: 35.78264 lon: -80.8873 facility: Accellacare Wilmington status: RECRUITING city: Wilmington state: North Carolina zip: 28401 country: United States lat: 34.22573 lon: -77.94471 facility: Remington Davis Inc status: RECRUITING city: Columbus state: Ohio zip: 43215 country: United States lat: 39.96118 lon: -82.99879 facility: Family Practice Center of Wadsworth Inc. status: RECRUITING city: Wadsworth state: Ohio zip: 44281-9236 country: United States lat: 41.02561 lon: -81.72985 facility: Lynn Institute of Norman status: RECRUITING city: Norman state: Oklahoma zip: 73072 country: United States lat: 35.22257 lon: -97.43948 facility: The University of Penn Center status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104-3317 country: United States lat: 39.95233 lon: -75.16379 facility: Preferred Primary Care Physicians_Pittsburgh status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15243 country: United States lat: 40.44062 lon: -79.99589 facility: Velocity Clin Res Providence status: RECRUITING city: East Greenwich state: Rhode Island zip: 02818 country: United States lat: 41.66038 lon: -71.45589 facility: Medical University Of South Carolina status: NOT_YET_RECRUITING city: Charleston state: South Carolina zip: 29425 country: United States lat: 32.77657 lon: -79.93092 facility: Spartanburg Medical Research status: RECRUITING city: Spartanburg state: South Carolina zip: 29303 country: United States lat: 34.94957 lon: -81.93205 facility: Holston Medical Group Pc status: RECRUITING city: Bristol state: Tennessee zip: 37620-7352 country: United States lat: 36.59511 lon: -82.18874 facility: Baylr Sctt White Rs Inst, Endo status: WITHDRAWN city: Dallas state: Texas zip: 75226 country: United States lat: 32.78306 lon: -96.80667 facility: Velocity Clinical Res-Dallas status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States lat: 32.78306 lon: -96.80667 facility: North Texas Endocrine Center status: RECRUITING city: Dallas state: Texas zip: 75231 country: United States lat: 32.78306 lon: -96.80667 facility: UT Southwestern Medical Center - Lingvay status: RECRUITING city: Dallas state: Texas zip: 75390 country: United States lat: 32.78306 lon: -96.80667 facility: DCOL Ctr for Clin Res status: RECRUITING city: Longview state: Texas zip: 75605 country: United States lat: 32.5007 lon: -94.74049 facility: Washington Cntr Weight Mgmt status: RECRUITING city: Arlington state: Virginia zip: 22206 country: United States lat: 38.88101 lon: -77.10428 facility: Health Res of Hampton Roads status: RECRUITING city: Newport News state: Virginia zip: 23606 country: United States lat: 37.08339 lon: -76.46965 facility: TPMG Clinical Research status: RECRUITING city: Newport News state: Virginia zip: 23606 country: United States lat: 37.08339 lon: -76.46965 facility: National Clin Res Inc. status: RECRUITING city: Richmond state: Virginia zip: 23294 country: United States lat: 37.55376 lon: -77.46026 facility: Paratus Clinical status: NOT_YET_RECRUITING city: Blacktown state: New South Wales zip: 2148 country: Australia lat: -33.76667 lon: 150.91667 facility: Northern Beaches Clinical Research status: RECRUITING city: Brookvale state: New South Wales zip: 2100 country: Australia lat: -33.76108 lon: 151.27446 facility: Holdsworth House Clinical Research status: RECRUITING city: Darlinghurst state: New South Wales zip: 2010 country: Australia lat: -33.87939 lon: 151.21925 facility: Novatrials status: RECRUITING city: Kotara state: New South Wales zip: 2289 country: Australia lat: -32.95 lon: 151.68333 facility: Paratus Clinical status: NOT_YET_RECRUITING city: Herston state: Queensland zip: 4006 country: Australia lat: -27.44453 lon: 153.01852 facility: University of Sunshine Coast status: RECRUITING city: Sippy Downs state: Queensland zip: 4556 country: Australia lat: -26.71793 lon: 153.05475 facility: CMAX Clinical Research status: NOT_YET_RECRUITING city: Norwood state: South Australia zip: 5067 country: Australia lat: -34.66667 lon: 149.73333 facility: Emeritus Research Melbourne status: NOT_YET_RECRUITING city: Camberwell state: Victoria zip: 3124 country: Australia lat: -37.84205 lon: 145.0694 facility: Austin Health, Metabolic Disorders Centre status: RECRUITING city: Heidelberg Heights state: Victoria zip: 3081 country: Australia lat: -37.74313 lon: 145.05695 facility: Linear Clinical Research status: WITHDRAWN city: Nedlands state: Western Australia zip: 6009 country: Australia lat: -31.98184 lon: 115.8073 facility: OCROM Clinic status: RECRUITING city: Suita-shi state: Osaka zip: 565-0853 country: Japan lat: 34.76143 lon: 135.51567 facility: ToCROM Clinic status: RECRUITING city: Tokyo zip: 160-0008 country: Japan lat: 35.6895 lon: 139.69171 hasResults: False

 nctId: NCT06326047 id: NN9541-4945 id: U1111-1291-9196 type: OTHER domain: World Health Organization (WHO) id: jRCT2031230704 type: REGISTRY domain: JRCT briefTitle: A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes overallStatus: RECRUITING date: 2024-03-18 date: 2024-11-25 date: 2025-08-26 date: 2024-03-22 date: 2024-04-18 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study will look at how well a new medicine called NNC0519-0130 helps people with type 2 diabetes lower their blood sugar and body weight. The study will test up to 7 different doses of NNC0519-0130. Which treatment participant will get is decided by chance. Participants will take 1-3 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 40 weeks. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Sponsor staff involved in the clinical trial is masked according to company standard procedures. The study will be double-blinded within dose level of once weekly subcutaneously administered NNC0519-0130 and the corresponding volume-matched placebo arms. The active comparator arm with tirzepatide will be open label. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 288 type: ESTIMATED name: NNC0519-0130 name: Placebo name: Trizepatide measure: Change in Glycated haemoglobin (HbA1c) measure: Change in Glycated haemoglobin (HbA1c) measure: Relative change in body weight measure: Change in body weight measure: Change in fasting plasma glucose (FPG) measure: Continuous glucose monitoring (CGM): Change in time in range (TIR) 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL)) measure: Change in waist circumference measure: Change in systolic blood pressure (SBP) measure: Change in high sensitivity C-Reactive Protein (hsCRP) measure: Change in total cholesterol measure: Change in high-density lipoprotein (HDL) cholesterol measure: Change in low-density lipoprotein (LDL) cholesterol measure: Change in triglycerides measure: Number of adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Velocity Clin Res-Chula Vista status: RECRUITING city: Chula Vista state: California zip: 91911 country: United States lat: 32.64005 lon: -117.0842 facility: Valley Research status: NOT_YET_RECRUITING city: Fresno state: California zip: 93720 country: United States lat: 36.74773 lon: -119.77237 facility: Valley Research status: WITHDRAWN city: Fresno state: California zip: 93720 country: United States lat: 36.74773 lon: -119.77237 facility: Velocity Clin Res San Diego status: RECRUITING city: La Mesa state: California zip: 91942 country: United States lat: 32.76783 lon: -117.02308 facility: First Valley Med Grp Lancaster status: RECRUITING city: Lancaster state: California zip: 93534 country: United States lat: 34.69804 lon: -118.13674 facility: Torrance Clin Res Inst, Inc. status: RECRUITING city: Lomita state: California zip: 90717 country: United States lat: 33.79224 lon: -118.31507 facility: Pacific Clinical Studies status: RECRUITING city: Los Alamitos state: California zip: 90720 country: United States lat: 33.80307 lon: -118.07256 facility: Catalina Research Institute, LLC status: RECRUITING city: Montclair state: California zip: 91763 country: United States lat: 34.07751 lon: -117.68978 facility: Med Partners, Inc. status: RECRUITING city: Toluca Lake state: California zip: 91602 country: United States lat: 34.15262 lon: -118.35731 facility: UCLA Health Southbay Endocrine status: NOT_YET_RECRUITING city: Torrance state: California zip: 90505 country: United States lat: 33.83585 lon: -118.34063 facility: University Clin Investigators status: RECRUITING city: Tustin state: California zip: 92780 country: United States lat: 33.74585 lon: -117.82617 facility: University of Colorado Hospital status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 facility: Innovative Research of W Florida Inc. status: RECRUITING city: Clearwater state: Florida zip: 33756 country: United States lat: 27.96585 lon: -82.8001 facility: International Research Associates, LLC_Miami status: RECRUITING city: Miami state: Florida zip: 33183 country: United States lat: 25.77427 lon: -80.19366 facility: Centricity Research status: RECRUITING city: Columbus state: Georgia zip: 31904 country: United States lat: 32.46098 lon: -84.98771 facility: Elite Clinical Trials status: RECRUITING city: Blackfoot state: Idaho zip: 83221 country: United States lat: 43.19047 lon: -112.34498 facility: Methodist Medical_Center of Illinois status: RECRUITING city: Peoria state: Illinois zip: 61636 country: United States lat: 40.69365 lon: -89.58899 facility: MD Medical Research status: RECRUITING city: Oxon Hill state: Maryland zip: 20745 country: United States lat: 38.80345 lon: -76.9897 facility: Endo And Metab Cons status: WITHDRAWN city: Rockville state: Maryland zip: 20852 country: United States lat: 39.084 lon: -77.15276 facility: Clinvest Research status: RECRUITING city: Springfield state: Missouri zip: 65807 country: United States lat: 37.21533 lon: -93.29824 facility: Mercury Str Med Grp, PLLC status: RECRUITING city: Butte state: Montana zip: 59701 country: United States lat: 46.00382 lon: -112.53474 facility: Palm Research Center Inc-Vegas status: RECRUITING city: Las Vegas state: Nevada zip: 89128 country: United States lat: 36.17497 lon: -115.13722 facility: Velocity Clinical Research Binghamton status: RECRUITING city: Binghamton state: New York zip: 13905 country: United States lat: 42.09869 lon: -75.91797 facility: PharmQuest Life Sciences LLC status: RECRUITING city: Greensboro state: North Carolina zip: 27408 country: United States lat: 36.07264 lon: -79.79198 facility: Accellacare Wilmington status: NOT_YET_RECRUITING city: Wilmington state: North Carolina zip: 28401 country: United States lat: 34.22573 lon: -77.94471 facility: Accellacare Wilmington status: RECRUITING city: Wilmington state: North Carolina zip: 28401 country: United States lat: 34.22573 lon: -77.94471 facility: Diab & Endo Assoc of Stark Co status: RECRUITING city: Canton state: Ohio zip: 44718 country: United States lat: 40.79895 lon: -81.37845 facility: Velocity Clin Res_Cincinnati status: RECRUITING city: Cincinnati state: Ohio zip: 45242 country: United States lat: 39.12713 lon: -84.51435 facility: Velocity Clinical Research Springdale status: RECRUITING city: Cincinnati state: Ohio zip: 45246 country: United States lat: 39.12713 lon: -84.51435 facility: Providence Health Partners Ctr status: RECRUITING city: Dayton state: Ohio zip: 45439 country: United States lat: 39.75895 lon: -84.19161 facility: Advanced Med Res Maumee status: RECRUITING city: Maumee state: Ohio zip: 43537 country: United States lat: 41.56283 lon: -83.65382 facility: Tristar Clin Investigations, PC status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19114 country: United States lat: 39.95233 lon: -75.16379 facility: Preferred Primary Care Physicians Inc. status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15243 country: United States lat: 40.44062 lon: -79.99589 facility: Preferred Primary Care Physicians, Inc. status: RECRUITING city: Uniontown state: Pennsylvania zip: 15401 country: United States lat: 39.90008 lon: -79.71643 facility: Velocity Clinical Research Abilene status: RECRUITING city: Abilene state: Texas zip: 79606 country: United States lat: 32.44874 lon: -99.73314 facility: Velocity Clin Res Austin status: RECRUITING city: Austin state: Texas zip: 78759 country: United States lat: 30.26715 lon: -97.74306 facility: Velocity Clinical Res-Dallas status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States lat: 32.78306 lon: -96.80667 facility: Endocrine Associates Houston status: RECRUITING city: Houston state: Texas zip: 77004 country: United States lat: 29.76328 lon: -95.36327 facility: Biopharma Informatic_Houston status: RECRUITING city: Houston state: Texas zip: 77043 country: United States lat: 29.76328 lon: -95.36327 facility: Biopharma Informatic_Houston status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77043 country: United States lat: 29.76328 lon: -95.36327 facility: Consano Clinical Research, LLC status: RECRUITING city: Shavano Park state: Texas zip: 78231 country: United States lat: 29.58495 lon: -98.55252 facility: Burke Internal Medicine & Research status: RECRUITING city: Burke state: Virginia zip: 22015 country: United States lat: 38.79345 lon: -77.27165 facility: TPMG Clinical Research status: RECRUITING city: Newport News state: Virginia zip: 23606 country: United States lat: 37.08339 lon: -76.46965 facility: Macquarie University status: NOT_YET_RECRUITING city: Macquarie Park state: New South Wales zip: 2109 country: Australia lat: -33.7751 lon: 151.11272 facility: Royal North Shore Hospital status: NOT_YET_RECRUITING city: St Leonards state: New South Wales zip: 2065 country: Australia lat: -33.82344 lon: 151.19836 facility: Western Endocrine Blacktown status: NOT_YET_RECRUITING city: Sydney state: New South Wales zip: 2148 country: Australia lat: -33.86785 lon: 151.20732 facility: Western Endocrine Blacktown status: WITHDRAWN city: Sydney state: New South Wales zip: 2148 country: Australia lat: -33.86785 lon: 151.20732 facility: Illawarra Diabetes Service Clinical Trials & Research Unit status: NOT_YET_RECRUITING city: Wollongong state: New South Wales zip: 2500 country: Australia lat: -34.424 lon: 150.89345 facility: University of Sunshine Coast status: NOT_YET_RECRUITING city: Birtinya state: Queensland zip: 4575 country: Australia lat: -26.74322 lon: 153.11913 facility: Eastern Clinical Research Unit Box Hill status: NOT_YET_RECRUITING city: Box Hill state: Victoria zip: 3128 country: Australia lat: -37.81887 lon: 145.12545 facility: Austin Health, Metabolic Disorders Centre status: NOT_YET_RECRUITING city: Heidelberg Heights state: Victoria zip: 3081 country: Australia lat: -37.74313 lon: 145.05695 facility: The Royal Melbourne Hospital status: NOT_YET_RECRUITING city: Parkville state: Victoria zip: 3050 country: Australia lat: -37.78333 lon: 144.95 facility: OCT Research ULC (dba Okanagan Clinical Trials) status: RECRUITING city: Kelowna state: British Columbia zip: V1Y 1Z9 country: Canada lat: 49.88307 lon: -119.48568 facility: OCT Research ULC (dba Okanagan Clinical Trials) status: NOT_YET_RECRUITING city: Kelowna state: British Columbia zip: V1Y 1Z9 country: Canada lat: 49.88307 lon: -119.48568 facility: Cook Street Medical Clinic status: RECRUITING city: Victoria state: British Columbia zip: V8V 4A1 country: Canada lat: 48.43294 lon: -123.3693 facility: G.A. Research Associates Ltd. status: RECRUITING city: Moncton state: New Brunswick zip: E1G 1A7 country: Canada lat: 46.09454 lon: -64.7965 facility: Nova Scotia Hlth Halifax status: NOT_YET_RECRUITING city: Halifax state: Nova Scotia zip: B3H 1V7 country: Canada lat: 44.64533 lon: -63.57239 facility: Wharton Med Clin Trials status: RECRUITING city: Hamilton state: Ontario zip: L8L 5G8 country: Canada lat: 43.25011 lon: -79.84963 facility: Albion Finch Medical Centre status: NOT_YET_RECRUITING city: Toronto state: Ontario zip: M9V 4B4 country: Canada lat: 43.70011 lon: -79.4163 facility: Albion Finch Medical Centre status: RECRUITING city: Toronto state: Ontario zip: M9V 4B4 country: Canada lat: 43.70011 lon: -79.4163 facility: Centricity Research Quebec City status: RECRUITING city: Levis state: Quebec zip: G6W 0M5 country: Canada lat: 46.80326 lon: -71.17793 facility: Recherche GCP Research status: NOT_YET_RECRUITING city: Montreal state: Quebec zip: H1Y 3H5 country: Canada lat: 45.50884 lon: -73.58781 facility: Centricity Research Ville St. Laurent VSL status: WITHDRAWN city: Ville Saint-Laurent state: Quebec zip: H4T 1Z9 country: Canada facility: Diex Recherche Quebec Inc. status: NOT_YET_RECRUITING city: Quebec zip: G1V 4T3 country: Canada lat: 46.81228 lon: -71.21454 facility: Life Care Clinic & Research Centre status: NOT_YET_RECRUITING city: Bangalore state: Karnataka zip: 560092 country: India lat: 12.97194 lon: 77.59369 facility: Amrita Institute Of Medical Sciences & Research Centre status: NOT_YET_RECRUITING city: Kochi state: Kerala zip: 682041 country: India lat: 9.93988 lon: 76.26022 facility: Seth GS Medical College & KEM Hospital status: NOT_YET_RECRUITING city: Mumbai state: Maharashtra zip: 400012 country: India lat: 19.07283 lon: 72.88261 facility: Chellaram Diabetes Institute status: NOT_YET_RECRUITING city: Pune state: Maharashtra zip: 411021 country: India lat: 18.51957 lon: 73.85535 facility: Christian Medical College Hospital, Vellore status: NOT_YET_RECRUITING city: Vellore state: Tamil Nadu zip: 632004 country: India lat: 12.9184 lon: 79.13255 facility: Kumudini Devi Diabetes Research Center, Ramdevrao Hospital status: NOT_YET_RECRUITING city: Hyderabad state: Telangana zip: 500072 country: India lat: 17.38405 lon: 78.45636 facility: MS Ramaiah status: NOT_YET_RECRUITING city: Bengaluru zip: 560054 country: India lat: 12.97194 lon: 77.59369 facility: Tokuyama clinic status: RECRUITING city: Chiba zip: 261-0004 country: Japan lat: 35.6 lon: 140.11667 facility: Soka Sugiura Internal Medicine Clinic status: RECRUITING city: Soka-shi, Saitama zip: 340-0015 country: Japan facility: Soka Sugiura Internal Medicine Clinic status: NOT_YET_RECRUITING city: Soka-shi, Saitama zip: 340-0015 country: Japan facility: Tokyo-Eki Center-building Clinic status: RECRUITING city: Tokyo zip: 103-0027 country: Japan lat: 35.6895 lon: 139.69171 facility: Fukuwa Clinic status: RECRUITING city: Tokyo zip: 104-0031 country: Japan lat: 35.6895 lon: 139.69171 facility: Fukuwa Clinic status: NOT_YET_RECRUITING city: Tokyo zip: 104-0031 country: Japan lat: 35.6895 lon: 139.69171 facility: Seoul National University Bundang Hospital status: NOT_YET_RECRUITING city: Gyeonggi-do zip: 13620 country: Korea, Republic of lat: 37.58944 lon: 126.76917 facility: Nowon Eulji Medical Center, Eulji University status: NOT_YET_RECRUITING city: Seoul zip: 01830 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Korea University Anam Hospital status: NOT_YET_RECRUITING city: Seoul zip: 02841 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Kangbuk Samsung Hospital status: NOT_YET_RECRUITING city: Seoul zip: 03181 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Asan Medical Center status: NOT_YET_RECRUITING city: Seoul zip: 05505 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Josha Research status: WITHDRAWN city: Bloemfontein state: Free State zip: 9301 country: South Africa lat: -29.12107 lon: 26.214 facility: Wits Bara Clinical Trial Site status: WITHDRAWN city: Johannesburg state: Gauteng zip: 2013 country: South Africa lat: -26.20227 lon: 28.04363 facility: Shop#1 Health Emporium status: WITHDRAWN city: Midrand state: Gauteng zip: 1685 country: South Africa lat: -25.98953 lon: 28.12843 facility: Dr Pillay's Rooms status: WITHDRAWN city: Durban state: KwaZulu-Natal zip: 4450 country: South Africa lat: -29.8579 lon: 31.0292 facility: Dr T Padayachee status: WITHDRAWN city: Umkomaas state: KwaZulu-Natal zip: 4170 country: South Africa lat: -30.20674 lon: 30.79776 hasResults: False

 nctId: NCT06326034 id: AAA234 briefTitle: Impact of Dapagliflozin as Add-on Therapy on Glycemic Status and Quality of Life in Type 2 Diabetic Patients overallStatus: COMPLETED date: 2022-05-01 date: 2023-01-01 date: 2023-01-01 date: 2024-03-22 date: 2024-03-22 name: Mohammed Mahmood Mohammed class: OTHER briefSummary: Type 2 Diabetes Mellitus (T2DM) is a syndrome of metabolic dysregulation that needs a multifactorial behavioral and pharmacological treatments to prevent or delay complications, morbidity and mortality. Uncontrolled hyperglycemia can be negatively affecting the patient's physical and psychological status and thus lower the patient's quality of life (QoL) (Verma \& Dadarwal, 2017)(Vanstone et al., 2015)(Gebremedhin et al., 2019). According to American Diabetes Association (ADA), when hyperglycaemia remain uncontrolled (HbA1c ≥1.5% above the glycemic target), a second therapy for T2DM is needed (Davies et al., 2022).

It has been certained by ADA, beside the glucose lowering effect the add-on antidibetic medication should have an impact on weight management to achieve and maintain the optimum glycemic and weight control which are the goals in people without established cardiorenal risks (Vijan et al., 2014((Inzucchi et al., 2012). Although metformin still the first-line pharmacotherapy in most T2DM patients, according to American Diabetes Association (ADA) (Association, 2020) but has little or even weight neutral effect, as well as gliptins (Hermansen \& Mortensen, 2007)(Sazan et al., 2012). Other old antidibetic classes such as thiazolidinediones (TZDs) and sulfonylureas (SUs) inspite of their efficacy in controlling glycemia but their use is associated with weight gain and other adverse effects (Derosa \& Maffioli, 2010)(Najim et al., 2014)(Fonseca, 2003). However, The newest class of antidibetic drugs, sodium-glucose cotransporter 2 inhibitors (SGLT2i), are approved for the treatment of T2DM as add-on or even initial therapy (Tamez-Pérez et al., 2013). This class is act by inducing glycosuria and thus improving glycemic status without affecting insulin level (Merovci et al., 2015). Dapagliflozin is a highly selective inhibitor of SGLT2. It has been well tolerated and its safety and efficacy approved in the clinical trials, mostly on cardio-renal outcomes with additional benefits of weight loss and low risk of hypoglycemia (Heerspink et al., 2020)(Solomon et al., 2022)(Wiviott et al., 2019)(McMurray et al., 2019). To date, no clinical data regarding SGLT2i recorded in Iraqi patients with limited data available on Arabic population. On Qatari, assessment of Dapagliflozin effectiveness revealed a significant improvement in the glycemic status after 6 months when used in combination with standard therapy, a reduction (Al AdAwi et al., 2019). In Saudi Arabia, Dapagliflozin was found to be well-tolerated and effective treatment option for T2DM patients after 6 months (Alguwaihes, 2021). conditions: Diabetic Nephropathy Type 2 studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This interventional randomized clinical study was conducted from May to December 2022, at the National Diabetic Centre for treatment and research/ Mustansiriyah University/ Baghdad/ Iraq. Ethical approval from the diabetic center and college of pharmacy/ Mustansiriyah University, was taken prior to the study initiation. All investigations/ procedures carried out in this study involving human participants were in accordance with the 1975 Declaration of Helsinki and its later amendments. primaryPurpose: TREATMENT masking: NONE count: 40 type: ACTUAL name: Dapagliflozin measure: Quality of Life Assessment tool sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mohammed Mahmood Mahmood city: Baghdad zip: 00964 country: Iraq lat: 33.34058 lon: 44.40088 hasResults: False

 nctId: NCT06326021 id: BJGBYY-IIT-LCYJ-2024-004 briefTitle: Optimised CD33 (FL-33) CAR T Therapy for Refractory/Relapsed Acute Myeloid Leukaemia overallStatus: RECRUITING date: 2024-04-11 date: 2026-06-15 date: 2026-12-30 date: 2024-03-22 date: 2024-04-16 name: Beijing GoBroad Hospital class: OTHER briefSummary: This study is a single-center, open-label, non-randomised, single-arm phaseⅠclinical trial to explore the safety and efficacy of FL-33 CAR T therapy for refractory/relapsed acute myeloid leukaemia. The primary endpoints are incidence and type of dose limiting toxicity within 21 days of CAR T infusion; total number, incidence and severity of adverse events (AE) 30 days after CAR T infusion. The secondary endpoints are total number, incidence and severity of AEs 30 days to 2 years after CAR T infusion; objective response rate (ORR), complete response rate (CR) and complete response with incomplete haematological recovery (CRi) by dose group at 15, 30 and 90 Days after CAR T Infusion; duration of response (DOR), progression-free survival (PFS), overall survival (OS); pharmacokinetic characteristics. The trial will use BOIN12 design to explore the optimal biological dose (OBD) of FL-33 CAR T cells for refractory/relapsed acute myeloid leukaemia. FL-33 CAR T is set at two dose levels: 5\*10\^5 (±20%) CAR-T cells/kg for dose 1 (DL-1) and 1\*10\^6 (±20%) CAR-T cells/kg for dose 2 (DL-2), and after the optimal biological dose (OBD) is determined in the dose exploration phase, the dose expansion phase will expand the trial by 6-12 cases at the OBD, enrolling up to 21-27 cases. Enrolment of more than 21 cases can be reported for analysis and the trial will be stopped when enrolment reaches 27 cases. conditions: Refractory/Relapsed Acute Myeloid Leukaemia studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: autologous FL-33 CAR T therapy name: prior-HSCT donor-derived FL-33 CAR T therapy measure: Dose-limiting toxicity(DLT) measure: Adverse events (AEs) measure: Long-term Adverse events (AEs) measure: Objective Response Rate (ORR) measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: The persistence of FL-33 CAR T cells sex: ALL minimumAge: 1 Year maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: BeijingGoBroadH status: RECRUITING city: Beijing country: China name: Tengyu Wang role: CONTACT phone: 18333186020 email: tengyu.wang@gohealtharo.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06326008 id: BJGBYY-IIT-LCYJ-2023-002 briefTitle: Safety, Tolerability, and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy for r/r B-ALL: a Clinical Trial overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-03-15 date: 2026-06-30 date: 2024-03-22 date: 2024-03-27 name: Beijing GoBroad Hospital class: OTHER briefSummary: This is an investigator-initiated, single-arm, open-label, non-randomised phase I clinical study. The objective of this trial is to evaluate the safety, tolerability and pharmacokinetics of donor-derived CD19 CAR Therapy bridged Allo-HSCT and sequential donor-derived CD22 CAR Therapy for r/r B-ALL and to explore the efficacy of this therapy preliminarily. The primary endpoints are incidence and type of dose-limiting toxicity (DLT) within 28 days (i.e., 43 days after donor-derived CD19 CAR T-cell infusion) after donor-derived CD19 CAR T-cell therapy bridged allogeneic haematopoietic stem cell transplantation; total number, incidence and severity of adverse events from donor-derived CD19 CAR T cell infusion back to 30 days after donor-derived CD22 CAR T cell infusion (i.e., within 120 days of donor-derived CD19 CAR T cell infusion). The secondary endpoints are total number, incidence and severity of adverse events from 120 days to 2 years after donor-derived CD19 CAR T-cell infusion; ORR(CR+CRi) on days 45, 90, 120; duration of response(DOR), event-free survival(EFS), overall survival(OS); pharmacokinetics characteristics. The trial plan to enroll 3\~12 cases in dose escalation phase and 36 cases in dose expansion phase. conditions: B-cell Acute Lymphoblastic Leukemia conditions: Acute Lymphoblastic Leukemia, in Relapse studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy measure: Dose-limiting toxicity (DLT) measure: Adverse events (AEs) measure: Long-term Adverse events (AEs) measure: Objective response rate(ORR) measure: Duration of response (DOR) measure: Event-free survival (EFS) measure: Overall survival (OS) measure: The persistence of CD19/CD22 CAR T cells. measure: The Maximum concentration (Cmax) of CD19/CD22 CAR T cells. measure: The time to maximum plasma concentration (Tmax) of CD19/CD22 CAR T cells. sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06325995 id: Changhai HHHospital briefTitle: Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer overallStatus: RECRUITING date: 2023-10-01 date: 2025-10-01 date: 2030-10-01 date: 2024-03-22 date: 2024-03-22 name: Changhai Hospital class: OTHER briefSummary: The aim of this trial is to compare the safety outcomes of Hypofractionated postprostatectomy radiotherapy (HYPORT) and Conventionally fractionated postprostatectomy radiotherapy(COPORT) in treating patients with localized prostate cancer.

Accumulating evidence has proven the safety and feasibility of HYPORT for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of HYPORT is still on its way.

It is not yet known whether giving HYPORT(57.5-65 Gy in 23-26 daily fractions of 2.5 Gy ) with or COPORT may work better in treating patients with prostate cancer. conditions: Localized Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 428 type: ESTIMATED name: Conventional radiation therapy name: Hypofractionated radiation therapy measure: Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events measure: 5-year progression-free survival (PFS) measure: quality of life (QoL) measure: medical expenses measure: Overall survival (OS) measure: Prostate cancer-specific survival sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Changhai hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200433 country: China name: Huojun Zhang, M.D. role: CONTACT phone: +8613311732399 email: chyyzhj@163.com name: Huojun Zhang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06325982 id: BYFFL-01 briefTitle: Clinical Observation of Drug Retention Enema in Preventing Acute Radiation-induced Rectal Injury overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-12-31 date: 2024-03-22 date: 2024-03-22 name: Fujian Cancer Hospital class: OTHER_GOV briefSummary: The main objective of this study was to evaluate the efficacy and safety of drug retention enema for the prevention of acute radiation rectal injury in the real world. conditions: Radiation Injuries conditions: Rectal Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 200 type: ESTIMATED name: Triethanolamine cream measure: Occurrence time of acute and chronic radiation rectal injury measure: Evaluation of acute and chronic radiation rectal injury measure: Clinical symptom assessment measure: Quality of life assessment assessed by IBDQ sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06325969 id: PCOS Immune briefTitle: PCOS Patients Immune Status Evaluation overallStatus: RECRUITING date: 2024-03-16 date: 2025-12-01 date: 2026-03-08 date: 2024-03-22 date: 2024-03-22 name: Shanghai 10th People's Hospital class: OTHER briefSummary: In this study, the investigators will include PCOS patients and healthy women who meet the trial criteria from the clinical research centers of 3 hospitals, introduce the content of this study to participants, and invite participants to participate. Flow cytometry was used to detect the immune function of peripheral blood samples of PCOS patients, to clarify the immune function characteristics of PCOS patients, and to try to establish an evaluation method of the immune function of PCOS patients. conditions: Polycystic Ovary Syndrom conditions: Metformin conditions: Immune Function studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Detect the immune function of peripheral blood samples measure: The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry. measure: The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry. measure: Homeostasis model assessment of insulin resistance measure: body mass index measure: menstrual frequency measure: fasting glucose measure: fasting insulin measure: Total cholesterol measure: Triglycerides measure: HDL-c measure: LDL-c measure: total testosterone measure: free testosterone measure: Sex hormone-binding globulin measure: Androstenedione measure: Dehydroepiandrosterone sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Department of Endocrinology, Shanghai Tenth People's Hospital status: RECRUITING city: Shanghai zip: 200072 country: China name: Manna Zhang, Doctor role: CONTACT phone: +86-021-66301004 email: mannazhang@126.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06325956 id: Immune status and metformin briefTitle: PCOS Immune Function Predicts Metformin Efficacy overallStatus: RECRUITING date: 2024-03-16 date: 2025-12-01 date: 2026-07-01 date: 2024-03-22 date: 2024-03-22 name: Shanghai 10th People's Hospital class: OTHER briefSummary: In this study, the investigators will include PCOS patients who meet the trial criteria, introduce participants to the content of this study, and invite participants to participate. The immune function of peripheral blood samples of PCOS patients was detected by flow cytometry. Participants were further treated with metformin for 6 months and followed up after the intervention. The objective of this study was to investigate immune markers related to the efficacy of metformin in PCOS patients and to predict the efficacy of metformin in PCOS patients using immune function. conditions: Polycystic Ovary Syndrome conditions: Metformin conditions: Immune Function studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Metformin measure: The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry. measure: The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry. measure: Homeostasis model assessment of insulin resistance measure: body mass index measure: menstrual frequency measure: fasting glucose measure: fasting insulin measure: Total cholesterol measure: Triglycerides measure: HDL-c measure: LDL-c measure: total testosterone measure: free testosterone measure: Sex hormone-binding globulin measure: Androstenedione measure: Dehydroepiandrosterone sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Department of Endocrinology, Shanghai Tenth People's Hospital status: RECRUITING city: Shanghai zip: 200072 country: China name: Manna Zhang, Doctor role: CONTACT phone: 86-21-66301004 email: mannazhang@126.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06325943 id: CIDPRIT briefTitle: Rituximab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy acronym: CIDPRIT overallStatus: COMPLETED date: 2019-04-01 date: 2023-05-30 date: 2023-11-30 date: 2024-03-22 date: 2024-03-26 name: Istituto Clinico Humanitas class: OTHER name: Ospedale Mondino di Pavia name: University of Turin, Italy name: Istituto Neurologico Carlo Besta di Milano name: San Raffaele University Hospital, Italy name: Università di Messina name: Universita degli Studi di Genova name: Istituto Di Ricerche Farmacologiche Mario Negri name: Università di Napoli Federico II briefSummary: Randomized double-blind controlled study of rituximab versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) on chronic treatment with immunoglobulins. The primary objective of the study is to determine whether rituximab treatment is effective in preventing the disease from getting worse after stopping immunoglobulin treatment for six months in patients with CIDP. The secondary objective is to evaluate whether treatment with rituximab can improve the response to therapy compared to placebo in patients treated with immunoglobulins and whether it can allow to delay the mean time of worsening after discontinuation of immunoglobulin therapy.

Exploratory objectives are the correlation between response to rituximab therapy and the clinical form of CIDP and the presence of antibody reactivity against node of Ranvier antigens. Intervention will be Rituximab or placebo, 1 g by intravenous infusion on day 1 and 15 after randomization and concomitant treatment for 6 months with intravenous or subcutaneous immunoglobulin at the same dosage as before randomization. conditions: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a phase 3, multicenter, randomized, placebo-controlled, parallel-group, double-blind study primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 37 type: ACTUAL name: Rituximab name: Placebo measure: Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability measure: Medical Research Council (MRC), range 0-60 with lower values meaning more severe disability measure: Inflammatory Rasch-built Overall Disability Scale (I-RODS), range 0-48 with lower values meaning more severe disability measure: Inflammatory Neuropathy Cause and Treatment (INCAT) scale, , range 0-10 points with higher values meaning more severe disability measure: Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability measure: treatment suspension measure: time to worsening measure: Short Form Health Survey 36 (SF-36), range from 0 to 100, with a higher score defining a more favorable health state measure: motor conduction block in the two most relevant nerves, range 0-100% with lower score defining lesser degree of impairment measure: clinical form measure: response to rituximab in patients with antinerve antibodies sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Clinico Humanitas city: Rozzano country: Italy lat: 45.38193 lon: 9.1559 hasResults: False

 nctId: NCT06325930 id: RIV-HU6-105 briefTitle: A Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-HU6 overallStatus: RECRUITING date: 2024-03-26 date: 2024-05-22 date: 2024-05-22 date: 2024-03-22 date: 2024-04-17 name: Rivus Pharmaceuticals, Inc. class: INDUSTRY briefSummary: This is a single-center, non-randomized, open-label Phase 1 study to characterize the absorption, metabolism, excretion, mass balance, pharmacokinetics (PK), safety and tolerability of HU6 following administration of a single dose of \[14C\]-HU6 in a fed state with a standard meal administered approximately 15 minutes prior to dosing. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: [14C]-HU6 measure: To assess the mass balance sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Pharmaron Clinical Pharmacology Center (CPC) status: RECRUITING city: Baltimore state: Maryland zip: 21201 country: United States name: Kristin Satterfield, MD, PhD role: CONTACT lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06325917 id: 101271-5 briefTitle: Effect of Diabetes Self-management Education and Support on Glycemic Control Among Patients With Type 2 Diabetic acronym: DSMES overallStatus: ACTIVE_NOT_RECRUITING date: 2022-11-01 date: 2024-07-01 date: 2024-07-30 date: 2024-03-22 date: 2024-03-22 name: University of Jordan class: OTHER briefSummary: Introduction: Diabetes mellitus (DM) is one of the chronic diseases that can have an impact on increasing morbidity, disability, and death. Social media has become a valuable resource for people with diabetes in improving self-management skills Applying diabetes self-management education with ongoing support using social media produces behavioral changes, empowerment, and cost-effectiveness.

purpose: the purpose of this study is to examine the effect of self-management education with ongoing support using social media (WhatsApp) on glycemic control among patients with uncontrolled diabetes.

Method: 140 patients with diabetes type 2 attending outpatients' diabetes clinic setting in Aqaba will participate in a two-arm randomized controlled trial study. Self-management education will be applied for all participants, ongoing support using social media (what's app) will be applied to the intervention group, and only usual diabetes care by a diabetes specialist nurse will be applied to the control group. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: two arms parallel randomized controlled primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 140 type: ACTUAL name: what's app ongoing support name: usual care measure: glycemic control measure: diabetes self management behaviors sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Jordan city: Amman zip: 11942 country: Jordan lat: 31.95522 lon: 35.94503 hasResults: False

 nctId: NCT06325904 id: 9138930 briefTitle: Uniportal VATS Versus Chest Tube for Early Empyema overallStatus: COMPLETED date: 2021-03-01 date: 2023-06-01 date: 2023-12-01 date: 2024-03-22 date: 2024-03-25 name: Minia University class: OTHER briefSummary: This randomized controlled study compared uniportal video-assisted thoracoscopic surgery (U-VATS) versus chest tube drainage for initial (first-line) treatment of stage I (exudative) and stage II (fibrinopurulent) empyema in adult patients (\>18 years old). The primary end-point of outcome was the overall success of treatment (no need for re-intervention or death). The main results demonstrated the safety of minimally invasive U-VATS procedure in the initial treatment of early stages of pleural empyema in comparison to traditional chest tube drainage. Initial use of U-VATS was safe and feasible due to postoperative freedom from complex or marked effusion, in addition to significant reduction in the need for additional intervention, postoperative complications, length of hospital stay, and total cost. conditions: Empyema, Pleural studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 70 type: ACTUAL name: Uniportal VATS name: Tube thoracostomy measure: Need for further management measure: Mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Minia University city: Minya zip: 61111 country: Egypt lat: 28.10988 lon: 30.7503 hasResults: False

 nctId: NCT06325891 id: RP025 briefTitle: Microbiota in Gastric Cancer by Gastric Mucosal Brushing overallStatus: RECRUITING date: 2024-02-01 date: 2025-03-31 date: 2025-05-31 date: 2024-03-22 date: 2024-03-22 name: King Chulalongkorn Memorial Hospital class: OTHER briefSummary: Many studies have shown a significant change of diversity and composition in gut microbiota across the gastric carcinogenesis process, particularly in patients with gastric cancer. However, there has been no analysis of gastric microbiota using the mucosal brushing technique, despites its favoring benefit in microbiota study. Therefore, our study aims to evaluate microbiota profile in patients with gastric cancer, compared to those without gastric cancer by using mucosal brush sampling. This will improve current knowledge of the potential role of the microbiome in patient gastric cancer as a future biomarker marker using brushing sampling. conditions: Gastric Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED name: Gastric mucosal brusing name: Gastric mucosal biopsy measure: Microbiome analysis using gastric mucosal brushing measure: Microbiome analysis using gastric mucosal biopsy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: King Chulalongkorn Memorial Hospital status: RECRUITING city: Bangkok zip: 10330 country: Thailand name: Rapat Pittayanon, MD role: CONTACT phone: +66813132112 email: rapat125@gmail.com name: Thanrada Vimonsuntirungsri role: CONTACT phone: +66853356240 email: aa_choc@docchula.com lat: 13.75398 lon: 100.50144 facility: King Chulalongkorn memorial hospital status: RECRUITING city: Bangkok zip: 10330 country: Thailand name: Thanrada Vimonsuntirungsri, MD role: CONTACT phone: +66853356240 email: aa_choc@docchula.com lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06325878 id: NEU2-OSS-2022-001 briefTitle: Genetic Architecture of Chronic Inflammatory Demyelinating Polyradiculoneuropathy acronym: GEARCIDP overallStatus: RECRUITING date: 2022-11-15 date: 2025-12-31 date: 2025-12-31 date: 2024-03-22 date: 2024-03-26 name: Istituto Clinico Humanitas class: OTHER briefSummary: The objective of this study is to characterize the genetic architecture of a large cohort of CIDP patients to evaluate whether specific alleles/haplotypes are implicated in the risk of CIDP, in its clinical and immunological variability, severity, therapeutic response, and association with diabetes and other autoimmune diseases. We will genotype \>700,000 single nucleotide polymorphisms (SNPs) by using the Illumina Global Screening Array (GSA), of approximately 1000 patients with CIDP. About 3500 healthy controls from the Italian population have been already genotyped using GWAS from our genetic department. Alleles/haplotypes will be also compared between patients with typical CIDP and its variants, between CIDP patients with and without specific antibodies, between CIDP patients with and without comorbidities, between CIDP patients with low and high levels of disability and between CIDP patients with and without response to each individual treatment (IVIg, steroids, plasma exchange) conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 3500 type: ESTIMATED name: Genome-wide association study measure: single nucleotide polymorphisms (SNPs) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Clinico Humanitas status: RECRUITING city: Rozzano country: Italy name: Eduardo Nobile Orazio, Prof role: CONTACT email: eduardo.nobile@unimi.it lat: 45.38193 lon: 9.1559 hasResults: False

 nctId: NCT06325865 id: 23C305 briefTitle: Perception of Unpleasant Sensations During Study Procedures in ALS Patients acronym: PESALS overallStatus: RECRUITING date: 2023-04-19 date: 2024-11 date: 2024-12 date: 2024-03-22 date: 2024-03-22 name: Istituto Auxologico Italiano class: OTHER briefSummary: Diagnosis of Amyotrophic Lateral Sclerosis (ALS) is considered a traumatic life event for both the patient and their next-of-kin/carers, due to the lack of treatment. Clinical Trials can offer pioneering treatment to reduce the impact of the disease and improve future treatments worldwide. Research protocols may involve routine diagnostic and/or therapeutic procedures which the patients may be already aware of and, therefore, expecting specific sensations. These could compromise participation or drop-out rate. Despite everything, participation in a clinical trial can guarantee continuity of care also thanks to the execution of these same procedures, through preferential access compared to other patients.

Aim of this study is to investigate the unpleasant sensations perceived by ALS patients during procedures in clinical trials. Analysing what type of pain/discomfort frightens patients during diagnostic and/or therapeutic procedures, including the different methods of administration of the study drug. Provide data to implement effective therapy and offer constant patients support throughout ALS specific and needed procedures. Evaluate if this support could influence adherence rate of ALS patients to conduct clinical trials as required. Provide information for future studies to create an ALS Clinical Trials multiple-retention-factors adherence scale. Create and implement an ALS-specific pain scale accounting for its impact on daily activities, aiding an interdisciplinary approach of pain management. Identify the best pain management strategies and compliance techniques to address ALS, not merely in clinical trials. Provide the best individualized care for ALS patients improving their quality of life and mental state.

This is a descriptive phenomenological study and data will be analyzed according to Sundler's method. Based on the experience of the researchers and the recommendations proposed by Sandelowski, a total of 20 interviews are estimated in order to reach the theoretical saturation per category of reference. Data collection will be carried out through in-depth semi-structured interviews recorded (13 open-ended questions after the execution of the procedures). conditions: Amyotrophic Lateral Sclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 20 type: ESTIMATED name: Interview measure: Prevalence of experience of unpleasant sensations or pain measure: Study procedure that causes unpleasant sensations or pain measure: Duration of unpleasant sensations or pain caused by the study procedure measure: HADS score measure: ALSFRS score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico italiano IRCSS, San Luca Hospital status: RECRUITING city: Milano zip: 20145 country: Italy name: Martina Sodano role: CONTACT phone: +39-02619111 phoneExt: 2937 email: m.sodano@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06325852 id: 22-5772 briefTitle: Directional Bilateral Thalamic Patterned Stimulation (Chronos) overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2027-01-01 date: 2024-03-22 date: 2024-03-25 name: Alfonso Fasano class: OTHER name: Boston Scientific Corporation briefSummary: Population Size and Eligible Patients: The investigators aim to recruit 5 to 10 patients with tremors who have previously undergone Ventral Intermedius Deep Brain Stimulation (VIM-DBS) treatment but have experienced early or late loss of benefits. Additionally, the investigators will enroll ten patients with essential tremor who require VIM-DBS surgery. These individuals will undergo bilateral implantation of Boston Scientific Genus Implantable Pulse Generator (IPG) devices, connected to Boston Scientific Cartesia™ 8-contact Directional Leads.

Study Design: This study comprises two distinct phases. Phase 1 is a cross-sectional investigation designed to identify the optimal algorithm for patterned stimulation in the VIM region . Phase 2 is a prospective clinical trial focusing on the assessment of safety and efficacy of bilateral VIM-DBS in patients with essential tremor.

Objectives: The primary objective in Phase 2 is to evaluate the safety and effectiveness of bilateral VIM-DBS in individuals with essential tremor. In Phase 1, the investigators seek to explore the impact of the Chronos programming software on tremor patients who have experienced early or late loss of benefits. conditions: Essential Tremor studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: DBS programing measure: Tremor Rating Scale (Part A-B) measure: Tremor analysis measure: Tremor Rating Scale (A-C) measure: Tremor analysis (meter per second squared) measure: Gait speed (meter per second) measure: Base of support (meter) measure: Step length (meter) measure: Stride length (meter) measure: Single stance time and double stance time (seconds) measure: Tandem gait measure: Posturography (newtons) measure: Quality of life in Essential Tremor Questionnaire (QUEST) measure: Speech analysis sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Movement Disorders Centre - Toronto Western Hospital city: Toronto state: Ontario zip: M5T 2S8 country: Canada name: Alfonso Fasano, MD, PhD role: CONTACT phone: (416) 603-5800 phoneExt: 5961 email: alfonso.fasano@uhn.ca lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06325839 id: GRU-SBF-ES-01 briefTitle: Effects of HypnoBirthing Training and Oxytocin Massage in Primiparous Pregnants overallStatus: COMPLETED date: 2023-04-01 date: 2023-09-10 date: 2023-09-10 date: 2024-03-22 date: 2024-03-22 name: Giresun University class: OTHER briefSummary: This study was conducted to determine the effects of hypnobirthing training and oxytocin massage on birth and postpartum period in primiparous pregnant women. conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The research is an experimental study with a randomized control group. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Pregnant women included in the study were randomly divided into two groups using the sealed envelope method. whoMasked: PARTICIPANT count: 50 type: ACTUAL name: HypnoBirthing training and oxytocin massage group measure: Wijma Birth Anticipation/Experience Scale A (W-DEQ-A) measure: Wijma Birth Expectancy/Expectation Scale B (W-DEQ-B) measure: Postpartum Breastfeeding Self-Efficacy Scale - Short Form measure: Mother-Infant Attachment Scale (MICS) measure: Birth satisfaction scale short form (BSS-SF) sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Giresun Gynecology and Children's Diseases Hospital city: Giresun state: Center zip: 28200 country: Turkey lat: 40.91698 lon: 38.38741 hasResults: False

 nctId: NCT06325826 id: GES briefTitle: The Study of the Validation of General Evaluation Score (GES) in the Prediction of Hepatocellular Carcinoma Risk Among Patients With Advanced Fibrosis and Cirrhosis Who Achieved Sustained Virological Response for Hepatitis C Virus After Direct Acting Antiviral Drugs overallStatus: ACTIVE_NOT_RECRUITING date: 2022-02-01 date: 2023-06-30 date: 2025-06-30 date: 2024-03-22 date: 2024-03-26 name: Egyptian Liver Hospital class: OTHER briefSummary: This cohort study aims to evaluate the validation of general evaluation score in the prediction of hepatocellular carcinoma risk among patients with advanced fibrosis (F3) and cirrhosis (F4) who achieved sustained virological response for hepatitis c virus after direct acting antiviral drugs and determine the group of these patients who require intensified surveillance. conditions: Hepatocellular Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ACTUAL name: General Evaluation Score (GES) measure: Hepatocellular Carcinoma sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Egyptian Liver Hospital city: Talkha state: Dakahlia zip: 36681 country: Egypt lat: 31.0539 lon: 31.37787 hasResults: False

 nctId: NCT06325813 id: CIN001 - ADHD PreSMART briefTitle: ADHD PreSMA Response Inhibition Therapy overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-06-30 date: 2026-12-31 date: 2024-03-22 date: 2024-03-22 name: Children's Hospital Medical Center, Cincinnati class: OTHER briefSummary: ADHD children have abnormal inhibitory control, meaning they have trouble stopping themselves from doing something they should not do. This ability to control involves an area in the brain called the pre-supplementary motor area (pre-SMA). Scientists have previously shown that the pre-SMA is abnormal in ADHD patients. In this study, we will use Transcranial Magnetic Stimulation (TMS) to stimulate the pre-SMA and determine the effects on measures that are related to inhibitory control. conditions: Attention Deficit Hyperactivity Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Active repetitive TMS name: Sham repetitive TMS measure: TMS-based Short-Interval Intracortical Inhibition (SICI) measure: EEG-based beta activity measure: TMS-based Cortical Silent Period (cSP) measure: EEG-based alpha activity measure: Stop Signal Reaction Time sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06325800 id: 2021401/2023007 id: Grant type: OTHER_GRANT domain: Juan Rodés Grant (JR23/00018) briefTitle: Glycoxidation, Arterial Biomechanics, and Target Organ Damage acronym: GlycOxiTod overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2029-12-31 date: 2024-03-22 date: 2024-04-09 name: Complejo Hospitalario Universitario de Santiago class: OTHER name: Instituto de Investigación Sanitaria de Santiago de Compostela name: Instituto de Salud Carlos III name: University of Santiago de Compostela name: Hospital de Barbanza briefSummary: Vascular target organ damage (TOD), defined as structural or functional deleterious changes in large and small arteries, is related to unfavorable arterial biomechanics, atherosclerosis and arteriosclerosis. Endothelial dysfunction due to unfavorable redox and glycation states on the bases of these phenomena. However, little is known about the role of glycoxidation on arterial biomechanics and TOD in apparently healthy individuals. The main hypothesis is that glycation and glycoxidation status are associated with arterial biomechanical abnormalities and TOD in patients with moderate to high cardiovascular risk. This is an observational, ambispective, and multicenter project that will include non-smoking patients over 18 years, without diabetes mellitus or established cardiovascular disease. Demographic, epidemiological, and clinical-anthropometric variables will be collected, including data from ambulatory blood pressure monitoring. The investigators will measure the serum percentage of glycated hemoglobin, glycated albumin, and fructosamine levels; along with quantification of skin advanced glycation and glycoxidation end productos (AGEs). Plasma concentration, activity, and structure of catalase, glutathione peroxidase, and superoxide dismutase in relation to the patient's glycation and glycoxidation status will be also evaluated. Concurrently, several biomechanical parameters will be assessed in the Common, Internal Carotid Artery, and distal limb arteries using ultrasound exploration. Incipient microvasculature damage will be also evaluated by retinal image. Patients will be followed up for the development of arterial biomechanical abnormalities and TOD, along with cardiovascular events. conditions: Oxidative Stress conditions: Cardiovascular Risk conditions: Target Organ Damage studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 500 type: ESTIMATED measure: Assessment of redox status (1) measure: Assessment of redox status (2) measure: Evaluation of glycation status (1) measure: Evaluation of glycation status (2) measure: Evaluation of glycation status (3) measure: Evaluation of glycation status (4) measure: Assessment of Glycoxidation status (1) measure: Assessment of Glycoxidation status (2) measure: Quantification of arterial targen organ damage (TOD) during the follow-up (1) measure: Quantification of arterial targen organ damage (TOD) during the follow-up (2) measure: Evaluation of cardiovascular disease during the follow-up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Complejo Hospitalario Universitario de Santiago de Compostela status: RECRUITING city: Santiago De Compostela state: A Coruña zip: 15706 country: Spain name: Nestor Vazquez Agra, PhD role: CONTACT phone: 0034981950000 email: nestor.vazquez.agra@sergas.es name: Nestor Vazquez-Agra, PhD role: PRINCIPAL_INVESTIGATOR name: Ana-Teresa Marques-Afonso, MD role: SUB_INVESTIGATOR name: Sofia Barbosa-Gouveia, PhD role: SUB_INVESTIGATOR name: Anton Cruces-Sande, PhD role: SUB_INVESTIGATOR name: Carla Diaz-Louzao, PhD role: SUB_INVESTIGATOR name: Iago Carballo, PhD role: SUB_INVESTIGATOR name: Lucia Barrera-Lopez, MD role: SUB_INVESTIGATOR name: Adela Lama-López, MD role: SUB_INVESTIGATOR name: Lucia Gomez-Suarez, MD role: SUB_INVESTIGATOR name: Ivan Fernandez-Castro, MD role: SUB_INVESTIGATOR name: Clara Casar-Cocheteux, MD role: SUB_INVESTIGATOR name: Alvaro Hermida-Ameijeiras, PhD role: SUB_INVESTIGATOR name: Arturo Gonzalez-Quintela, PhD role: SUB_INVESTIGATOR name: Antonio Pose-Reino, PhD role: SUB_INVESTIGATOR name: Francisco Gude-Sampedro, PhD role: SUB_INVESTIGATOR lat: 42.88052 lon: -8.54569 hasResults: False

 nctId: NCT06325787 id: S2021-211-02 briefTitle: Image-guided Thermal Ablation vs. Lobectomy for Solitary Papillary Thyroid Microcarcinoma overallStatus: COMPLETED date: 2013-05-01 date: 2017-01-31 date: 2024-01-31 date: 2024-03-22 date: 2024-03-25 name: Chinese PLA General Hospital class: OTHER briefSummary: To evaluate the clinical outcomes of image-guided thermal ablation versus thyroid lobectomy for the treatment of papillary thyroid microcarcinoma conditions: Papillary Thyroid Cancer studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1021 type: ACTUAL name: thyroid lobectomy name: image-guided thermal ablation measure: disease progression measure: disease-free survival measure: complications measure: procedure time measure: cost measure: estimated blood loss measure: hospitalization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06325774 id: Changhai HHospital briefTitle: Radical Hypofractionated Radiotherapy for Localized Prostate Cancer overallStatus: RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2031-04-01 date: 2024-03-22 date: 2024-03-22 name: Changhai Hospital class: OTHER briefSummary: The aim of this trial is to study the safety outcomes of hypofractionated radiotherapy in treating patients with localized prostate cancer.

Hypofractionated radiotherapy delivers higher doses of radiotherapy in a shorter time period, may enabling the killing of more tumor cells with fewer side effects.

Accumulating evidence has proven the safety and feasibility of hypofractionated radiotherapy for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of hypofractionated radiotherapy is still on its way. conditions: Localized Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Hypofractionated radiation therapy measure: Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events measure: biochemical progression-free survival (bPFS) measure: local progression-free-survival(LPFS) measure: distant metastasis free survival(DMFS) measure: Overall survival (OS) measure: Quality of life (QoL) sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changhai hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200433 country: China name: Huojun Zhang, M.D. role: CONTACT phone: +8613311732399 email: chyyzhj@163.com name: Huojun Zhang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06325761 id: SY-5007-I-02 briefTitle: A Study to Evaluate the Food Effects on Pharmacokinetics of SY-5007 Tablets in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-01 date: 2024-05-01 date: 2024-03-22 date: 2024-03-22 name: Shouyao Holdings (Beijing) Co. LTD class: OTHER briefSummary: This study is a single-center, randomized, open-label, single-dose, two-period, two-treatment crossover trial aimed at evaluating the pharmacokinetic (PK) profiles and safety of SY-5007 tablets administered orally to healthy subjects in both fasting and fed states in China. conditions: Health Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: SY-5007 name: SY-5007 measure: Cmax for SY-5007 measure: Tmax for SY-5007 measure: AUC0-t for SY-5007 measure: AUC0-∞ for SY-5007 measure: t½ for SY-5007 measure: CL/F for SY-5007 measure: Vz/F for SY-5007 measure: Safety of SY-5007 sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: West China Hospital of Sichuan University city: Chengdu state: Sichuan zip: 610041 country: China name: Li Zheng role: CONTACT phone: 86-28-85423655 email: zhengli@wchscu.cn lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06325748 id: SENTI-202-101 briefTitle: SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults With CD33 and/or FLT3 Blood Cancers Including AML/MDS overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-09 date: 2040-08 date: 2024-03-22 date: 2024-03-22 name: Senti Biosciences class: INDUSTRY briefSummary: This is an open-label study of the safety, biodynamics, and anti-cancer activity of SENTI-202 (an off-the-shelf logic gated CAR NK cell therapy) in patients with CD33 and/or FLT3 expressing blood cancers, including AML and MDS. conditions: AML/MDS conditions: CD33 Expressing Hematological Malignancies conditions: FLT3 Expressing Hematological Malignancies studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: SENTI-202 measure: Safety and tolerability for dose determination of SENTI-202 measure: Anti-cancer activity of SENTI-202 measure: Pharmacokinetic (PK) and pharmacodynamic (PDn) profile of SENTI-202 measure: Host immune response to SENTI-202 sex: ALL minimumAge: 18 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06325735 id: 98 briefTitle: Combined Systemic Inflammatory Indices and Birth Weight overallStatus: COMPLETED date: 2019-12-01 date: 2021-02-01 date: 2024-04-01 date: 2024-03-22 date: 2024-04-18 name: University of Campania "Luigi Vanvitelli" class: OTHER briefSummary: The study aimed to explore the complex relationship between various systemic inflammatory indices and birth weight conditions: Systemic Inflammation Markers conditions: Birth Weight conditions: Combined Systemic Inflammatory Indices studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 199 type: ACTUAL name: None intervention measure: Systemic inflammatory indices and birth weight sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn - city: Napoli state: Italia zip: 80138 country: Italy lat: 40.85216 lon: 14.26811 hasResults: False

 nctId: NCT06325722 id: 10001680 id: 001680-DK briefTitle: Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-07-31 date: 2026-07-31 date: 2024-03-22 date: 2024-04-26 name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) class: NIH briefSummary: Background:

In a previous study, participants were lived at the NIH and randomly received either a low-fat or a low-carbohydrate diet for 2 weeks and then switched to the other diet for 2 more weeks. Participants who received the low-carbohydrate diet first lost more body fat at the end of the study than those who received the low-fat diet first. Researchers want to see if they can repeat that result in a longer weight loss study when participants live at home.

Objective:

To test the effects of diet order in people receiving either a low-fat or low-carbohydrate diet first for 4 weeks and then immediately switched to the other diet for another 4 weeks.

Eligibility:

Adults aged 19 to 50 years with a body mass index of 25 or more.

Design:

Participants will complete the study at their homes, but there will be 3 required visits to the NIH. Participants will drink a special type of water 2 weeks before the baseline NIH visit and collect urine samples at home to measure how many calories they burn. Before the diets begin, participants will visit the NIH for baseline testing when they will have a metabolism test while relaxing in a bed with a plastic hood over their head to collect the air they breathe out. They will have scans to measure their bone density and how much muscle and body fat they have. They will give stool, blood, and urine samples.

Participants will be asked to eat a specific diet for 4 weeks followed by a different diet for 4 weeks. All meals will be delivered to the participants homes. They will eat only the foods delivered.

Participants will weigh themselves daily. They will wear a monitor to track their physical activity and a sensor to measure their glucose levels. They will prick their finger each morning to test a drop of blood for ketones. Participants will meet virtually as a group with the study team weekly. Participants will have two more NIH visits towards the end of each diet period.... conditions: Overweight conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Low-carbohydrate Diet name: Low-fat Diet measure: Change in total fat mass measure: Rate of body weight change from baseline to week 8 measure: Rate of body weight change during low-carbohydrate diet measure: Rate of body weight change during low-fat diet sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: National Institutes of Health Clinical Center city: Bethesda state: Maryland zip: 20892 country: United States name: Kevin Hall, Ph.D. role: CONTACT phone: 301-402-8248 email: kevinh@niddk.nih.gov lat: 38.98067 lon: -77.10026 hasResults: False

 nctId: NCT06325709 id: 10001580 id: 001580-I briefTitle: Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous Disease overallStatus: ENROLLING_BY_INVITATION date: 2024-04-17 date: 2032-12-31 date: 2032-12-31 date: 2024-03-22 date: 2024-04-26 name: National Institute of Allergy and Infectious Diseases (NIAID) class: NIH briefSummary: Background:

Chronic granulomatous disease (CGD) is a rare immune disorder caused by a mutation in the CYBB gene. People with CGD have white blood cells that do not work properly. This places them at risk of developing infections that may be life-threatening. Stem cell transplant can cure CGD but transplanting stem cells donated by other people can have serious complications. In addition, not everyone has a matched donor. Another approach is a type of gene therapy that involves base-editing to correct the mutation in a person s own stem cells. Researchers want to know if the base-edited stem cells can improve the white cells' functioning and result in fewer CGD-related infections.

Objective:

To learn if base-edited stem cells will improve white blood cells' ability to fight against infections in people with CGD.

Eligibility:

Males aged 18 years and older with X-linked CGD.

Design:

This is a non-randomized study. Participants with the specific mutation under study will be screened during the initial phase.

During the development phase, participants will undergo apheresis to collect stem cells for base-editing correction of the mutation.

During the treatment phase, participants will receive the base-edited cells after chemotherapy with busulfan. Participants will remain in the hospital until their immunity recovers.

Follow-up visits will continue for 15 years. conditions: Chronic Granulomatous Disease (CGD) conditions: X-Linked Chronic Granulomatous Disease studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Base-edited hematopoietic stem and progenitor cells name: Busulfan name: Palifermin name: Filgrastim name: Plerixafor measure: To evaluate the safety of base-edited autologous CD34+ cells measure: To evaluate the efficacy of base-edited autologous CD34+ cells measure: Evaluate the efficiency of base-editing. measure: Evaluate the engraftment capability of base-edited hematopoietic stem progenitor cells. measure: Evaluate the efficiency in restoring gp91phox expression. measure: Evaluate efficacy in restoring NADPH oxidase function. measure: Evaluate clinical efficacy measure: Evaluate the stability of gene correction sex: MALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institutes of Health Clinical Center city: Bethesda state: Maryland zip: 20892 country: United States lat: 38.98067 lon: -77.10026 hasResults: False

 nctId: NCT06325696 id: 10001577 id: 001577-E briefTitle: H01 in Adults With Interstitial Lung Disease (The SOLIS Study) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-22 date: 2024-04-26 name: National Institute of Environmental Health Sciences (NIEHS) class: NIH briefSummary: Background:

Interstitial lung disease affects the tissues that aid the transfer of oxygen and carbon dioxide between the air and the bloodstream. The disease can cause fibrosis, a thickening and scarring of lung tissue. Fibrosis often continues getting worse, and most people with this disease die in 3 to 5 years.

Objective:

To test a study drug (hymecromone) in people with interstitial lung disease or lung fibrosis.

Eligibility:

People aged 18 years and older with interstitial lung disease or lung fibrosis.

Design:

Participants will have at least 7 clinic visits over 5 months.

Participants will have screening and baseline visits. They will have blood tests and tests of their heart function. They will give a sputum sample. Other tests will include:

Spirometry: Participants will breathe in and out through a mouthpiece to measure how much air they can hold in their lungs and how hard they can breathe.

Diffusion capacity of lungs for carbon monoxide: Participants will breathe in a gas that contains a small amount of carbon monoxide. Then they will breathe through a mouthpiece. This test measures how well oxygen moves from the air into the blood.

Resting energy expenditure. Participants will lie still for 30 minutes with a clear dome over their head. This test measures the calories their body burns at rest.

6-minute walk test. Participants will walk at their normal pace for 6 minutes. Their vital signs and blood oxygen levels will be checked.

Hymecromone is a tablet taken by mouth. Participants will take 2 tablets every morning and 2 tablets every night for 12 weeks. Tests will be repeated at study visits. conditions: Interstitial Lung Disease conditions: Idiopathic Pulmonary Fibrosis conditions: Lung Diseases, Interstitial studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 37 type: ESTIMATED name: hymecromone measure: To evaluate the efficacy of H01 in reducing serum hyaluronan levels in participants with progressive ILD measure: Evaluate the safety and tolerability of oral H01 in participants with progressive ILD. measure: Evaluate the change in clinical and functional measures in participants with progressive ILD treated with H01. measure: Evaluate biomarkers of fibrosis in participants with progressive ILD treated with H01. measure: Evaluate pharmacokinetic changes from baseline in participants with progressive ILD treated with H01. sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NIEHS Clinical Research Unit (CRU) city: Research Triangle Park state: North Carolina zip: 27709 country: United States name: NIEHS Join A Study Recruitment Group role: CONTACT phone: 855-696-4347 email: myniehs@nih.gov lat: 35.90567 lon: -78.90497 hasResults: False

 nctId: NCT06325683 id: NCI-2024-01995 id: NCI-2024-01995 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: A072201 type: OTHER domain: Alliance for Clinical Trials in Oncology id: A072201 type: OTHER domain: CTEP id: U10CA180821 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180821 briefTitle: Anti-Lag-3 (Relatlinib) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma overallStatus: NOT_YET_RECRUITING date: 2024-06-21 date: 2028-07-15 date: 2028-07-15 date: 2024-03-22 date: 2024-03-22 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II trial compares the safety, side effects and effectiveness of anti-lag-3 (relatlinib) and anti-PD-1 blockade (nivolumab) to standard of care lomustine for the treatment of patients with glioblastoma that has come back after a period of improvement (recurrent). Relatlimab and nivolumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. Lomustine is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Relatlinib and nivolumab may be safe, tolerable, and/or effective compared to standard of care lomustine in treating patients with recurrent glioblastoma. conditions: Recurrent Glioblastoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 178 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Lomustine name: Magnetic Resonance Imaging name: Nivolumab name: Relatlimab name: Surgical Procedure measure: Overall survival (OS) measure: OS rate measure: Progression-free survival (PFS) measure: Radiographic response measure: Incidence of adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06325670 id: 23/50374 briefTitle: Type 2 Diabetes and Binge Eating Disorder (BED) overallStatus: RECRUITING date: 2024-02-23 date: 2024-12 date: 2025-06 date: 2024-03-22 date: 2024-03-22 name: Odense University Hospital class: OTHER name: Jascha Fonden name: Independent Research Fund Denmark briefSummary: The goal of this research project is to improve the treatment of individuals living with both type 2 diabetes (T2D) and Binge Eating Disorder (BED). The research hypothesizes that BED treatment will not only improve BED symptoms but also improve T2D severity and associated cardiovascular risk factors. The research involves a multidisciplinary team, including experts in endocrinology, psychology, and eating disorders.

The main questions it aims to answer are:

* Does treatment for Binge Eating Disorder lead to improvements in BED symptoms?
* Does treatment for Binge Eating Disorder lead to improvements in T2D severity and associated cardiovascular risk factors?

Participants will undergo a comprehensive treatment program targeting both BED and T2D. This program will include psychotherapy sessions focusing on cognitive-behavioral techniques to address binge eating behavior.

Researchers will compare participants' outcomes before and after the treatment program to assess changes in BED symptoms, T2D severity, and associated cardiovascular risk factors. conditions: Diabetes Mellitus, Type 2 conditions: Binge-Eating Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: BED treatment name: Waitlist measure: Number of binge eating episodes measure: Binge Eating Disorder Questionnaire measure: Glucose Sensor Data for Blood Glucose Profile measure: HbA1c measure: Eating Disorder Examination Questionnaire (EDE-Q) measure: Major Depression Inventory (MDI) measure: Problem Areas In Diabetes (PAID20) measure: Lipid profile measure: Body Mass Index (BMI) measure: Blood Pressure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Region Of Southern Denmark Locations status: RECRUITING city: Odense state: Region Of Southern Denmark zip: 5000 country: Denmark name: Pernille Fiil Nybo, Cand.psych. role: CONTACT phone: +45 2042 7108 email: Pernille.Fiil.Nybo@rsyd.dk name: Jakob Linnet, Dr. med., cand.psych. role: CONTACT phone: +45 2913 8045 email: jakob.linnet@rsyd.dk lat: 55.39594 lon: 10.38831 hasResults: False

 nctId: NCT06325657 id: C3671032 briefTitle: A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants acronym: MORISOT overallStatus: RECRUITING date: 2024-03-12 date: 2025-06-11 date: 2025-06-11 date: 2024-03-22 date: 2024-04-11 name: Pfizer class: INDUSTRY briefSummary: The purpose of the study is to learn about the safety and immune activity of the RSVpreF vaccine. It will be studied in infants born to mothers living with HIV. These infants may have higher chances of getting sick or dying due to RSV infection. Respiratory Syncytial Virus (RSV) is a common type of virus (germ) that can cause severe illness (airway diseases), where medical help is needed. Vaccines help your body make antibodies which help fight against diseases. The antibodies are substances your body uses to fight off an infection. The antibodies can be passed to the infant through the placenta of the mother.

The study will look at the safety, tolerability, and immune activity in mothers and their infants.

This study is seeking pregnant women who are:

* Less than or equal to 49 years old and have HIV (Human immunodeficiency virus -
* Receiving standard medical care during the pregnancy
* Do not have syphilis (bacterial sexually transmitted disease), Hepatitis B Virus ((HBV) liver infection), Tuberculosis ((TB) bacterial lung infection).
* Have been on stable (anti-retroviral) HIV treatment for more than or equal to 90 days.
* agree to be present for all study visits, procedures, and blood draws.

Participants will either receive:

* RSVpreF vaccine
* A placebo. A placebo does not have any medicine it but looks just like the study vaccine.

Pregnant participants will be involved in the study from:

* consent during their current pregnancy, and
* for 6 months after delivery of their baby (around 10 months in total). Pregnant participants will have at least 5 planned visits in this study. Infant participants: All eligible babies born to enrolled mothers will be followed up from birth for up to 6 months. Infant participants will have at least 3 study visits, with some site visits allowed to happen via home visits or over the telephone. conditions: Respiratory Syncytial Virus studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: This is a double-blinded, placebo-controlled study whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 330 type: ESTIMATED name: RSVpreF vaccine name: Placebp measure: Maternal Participants Primary Safety - The proportion of participants reporting systemic reactions measure: Maternal Participants Primary Safety - The proportion of participants reporting local reactions measure: Maternal Participants Primary Safety - The proportion of participants reporting Adverse Events (AEs) measure: Maternal Participants Primary Safety - The proportion of participants reporting Adverse Event of Special Interests (AESIs) measure: Maternal Participants Primary Safety - The proportion of participants reporting Serious Adverse Events (SAEs) measure: Infant Participants Primary Safety - The proportion of participants reporting Specific Birth Outcomes measure: Infant Participants Primary Safety - The proportion of participants reporting Adverse Events (AEs) measure: Infant Participants Primary Safety - The proportion of participants reporting SAEs and Newly Diagnosed Chronic Medical Conditions (NDCMCs) measure: Maternal Participants: Secondary Immunogenicity - GMT of NTs for RSV A and RSV B measure: Maternal Participants: Secondary Immunogenicity - GMFR of NTs for RSV A and RSV B sex: ALL minimumAge: 0 Years maximumAge: 49 Years stdAges: CHILD stdAges: ADULT facility: Synergy Biomed Research Institute status: NOT_YET_RECRUITING city: East London state: Eastern CAPE zip: 5241 country: South Africa lat: -33.01529 lon: 27.91162 facility: Josha Research status: NOT_YET_RECRUITING city: Bloemfontein state: FREE State zip: 9301 country: South Africa lat: -29.12107 lon: 26.214 facility: Worthwhile Clinical Trials status: RECRUITING city: Benoni state: Gauteng zip: 1500 country: South Africa lat: -26.18848 lon: 28.32078 facility: REIMED Reiger Park status: NOT_YET_RECRUITING city: Boksburg state: Gauteng zip: 1459 country: South Africa lat: -26.21197 lon: 28.25958 facility: Wits RHI status: NOT_YET_RECRUITING city: Johannesburg state: Gauteng zip: 2001 country: South Africa lat: -26.20227 lon: 28.04363 facility: University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA) status: NOT_YET_RECRUITING city: Johannesburg state: Gauteng zip: 2013 country: South Africa lat: -26.20227 lon: 28.04363 facility: Wits VIDA Nkanyezi Research Unit status: NOT_YET_RECRUITING city: Johannesburg state: Gauteng zip: 2093 country: South Africa lat: -26.20227 lon: 28.04363 facility: Wits VIDA Nkanyezi status: NOT_YET_RECRUITING city: Johannesburg state: Gauteng zip: 2093 country: South Africa lat: -26.20227 lon: 28.04363 facility: Botho Ke Bontle Health Services status: RECRUITING city: Pretoria state: Gauteng zip: 0184 country: South Africa lat: -25.74486 lon: 28.18783 facility: Setshaba Research Centre status: NOT_YET_RECRUITING city: Tshwane state: Gauteng zip: 0152 country: South Africa facility: Qhakaza Mbokodo Research Clinic status: NOT_YET_RECRUITING city: Ladysmith state: Kwazulu-natal zip: 3370 country: South Africa lat: -28.55874 lon: 29.77896 facility: Gole Biomed Research Centre status: RECRUITING city: Polokwane state: Limpopo zip: 0734 country: South Africa lat: -23.90449 lon: 29.46885 facility: MRC Unit on Child And Adolescent Health status: NOT_YET_RECRUITING city: Cape Town state: Western CAPE zip: 7700 country: South Africa lat: -33.92584 lon: 18.42322 hasResults: False

 nctId: NCT06325644 id: 2023H0258 id: CDMRP-PR212399-G type: OTHER_GRANT domain: Departent of Defense briefTitle: Well-Formulated Ketogenic Diet Polycystic Kidney Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2027-04-01 date: 2024-03-22 date: 2024-03-22 name: Ohio State University class: OTHER briefSummary: This is a prospective study to determine ketogenic diet effect on htTKV, GFR, microalbuminuria. This is a single-center study of 20 patients with ADPKD and deemed high risk for progression to ESRD. This determined by combination of features of ADPKD and htTKV as assessed by prior computed tomography (CT) or MRI. Patients will be recruited from the Polycystic Kidney Disease (PKD) Clinic at Ohio State University Wexner Medical Center. Enrolled patients will have MRI for htTKV, urinary studies, blood tests at baseline, 6 months, and 52 weeks. Blood for GFR will be assessed three times over the course of the study including baseline, 6 months, and 1 year. Participants will follow ketogenic diet for 52 weeks. Investigatory diet team will manage the ketogenic diet. conditions: Polycystic Kidney Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ESTIMATED name: Ketogenic Diet name: Ketone/Glucose Monitoring name: CGM/CKM name: Blood Draw name: Body Composition name: Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) . measure: Finger Stick Beta-Hydroxybutyrate measure: Finger Stick Glucose measure: Blood Pressure sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-01-07 uploadDate: 2024-03-19T14:40 filename: Prot_000.pdf size: 409140 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-07 uploadDate: 2024-03-19T14:40 filename: ICF_001.pdf size: 428384 hasResults: False

 nctId: NCT06325631 id: Ankara City Hospital Bilkent briefTitle: Comparative Evaluation of the Results of Facet Joint Injections overallStatus: RECRUITING date: 2023-01-02 date: 2024-03-31 date: 2024-04-30 date: 2024-03-22 date: 2024-03-22 name: Oznur Uzun class: OTHER briefSummary: Low back pain affects 60 to 90% of the total population. It is one of the most common causes of disability in adults. Low back pain can be originated from a wide variety of structures, and the facet joint is one of these structures. It is thought that 21 to 41% of low back pain originates from the facet joint. A wide variety of conservative treatments, including intra-articular injections, are used to treat low back pain originating from the facet joint. However, there is still no consensus on the most effective treatment method. With appropriate patient selection, facet joint injections can provide significant improvements in patients' pain scores. After Goldthwait defined the facet joint concept in 1911, Ghormley defined facet joint syndrome in 1933. The source of pain in 40-50% of patients is the lumbar facet joints. Innervation of the lumbar facet joints is provided by the medial branches of the dorsal roots of the spinal nerves. In 1975, Shealy described the coagulation of the articular nerve support of the spinal facet joints with the radiofrequency method. These methods have been further developed over time. The results of facet joint injections are satisfactory in well-selected patient groups. It has been shown that intra-articular steroid injection to the facet joint is superior to systemic steroid use in patients with low back pain. In this study, it was aimed to methodically compare the facet joint injections applied to patients diagnosed with facet syndrome in the outpatient clinic of the Physical Therapy and Rehabilitation Hospital in terms of patient pain scores, application time, effort spent and patient anxiety. Intra-articular injections will be performed under by fluoroscopy or ultrasound guidance or anatomic location. conditions: Low Back Pain, Mechanical conditions: Facet Syndrome of Lumbar Spine studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Intra-articular injection to lumbar facet joint measure: Visual Analogue Scale sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Ankara Bilkent Şehir Hastanesi status: RECRUITING city: Ankara country: Turkey name: Öznur UZUN, MD role: CONTACT phone: +905052912734 email: soznuruzuns@gmail.com lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06325618 id: 1-10-72-138-23 briefTitle: Lymphedema, Low-grade Inflammation and the Vasculature in Turner Syndrome acronym: TSCOR_V overallStatus: RECRUITING date: 2024-01-08 date: 2027-08 date: 2027-08 date: 2024-03-22 date: 2024-03-22 name: University of Aarhus class: OTHER name: Aarhus University Hospital briefSummary: 100 women with karyotype verified TS, previously examined at 4 study visits during a 19-year period will be asked to participate in a 5th study visit. Healthy age-matched females will be included as controls in a ratio 2:1.

The aim is to examine and quantify the cardiovascular and lymphatic system in women with TS. The investigators will study a possible causal mechanism between the known pathologic phenotype and alterations in these systems to understand, prevent or treat the life-threatening complications in TS. conditions: Turner Syndrome conditions: Cardiovascular Diseases conditions: Lymphedema conditions: Inflammation studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 150 type: ESTIMATED name: No intervention other than obtaining biopsies name: Indocyanine green (ICG) measure: Grade dysfunction of clinical and subclinical lymphedema using Indocyanine Green Lymphography and Magnetic Resonance Lymphangiography. measure: Detecting low-grade inflammation in Turner Syndrome preforming FDG-PET/CT-scans to locate low grade inflammation. measure: Heat maps of the distribution of wall shear stress in the aorta measure: MRI evaluation and description of vascular abnormalities in Turner Syndrome measure: Cardiac MRI to evaluate function measure: Cardiac MRI to evaluate fibrosis of the myocardium measure: Mapping DNA-methylations patterns in multiple tissues measure: Immunologic changes in Turner Syndrome sex: FEMALE minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aarhus University Hospital status: RECRUITING city: Aarhus N zip: 8200 country: Denmark name: Line Balsby, MD role: CONTACT phone: +4520461203 email: libals@clin.au.dk name: Claus Gravholt, MD, Prof. role: CONTACT lat: 56.15674 lon: 10.21076 hasResults: False

 nctId: NCT06325605 id: GRYY-LL-KJ2022-064 briefTitle: Efficacy and Safety of Bifidobacterium Combined With High-frequency Transcranial Magnetic Stimulation in the Treatment of Adolescent Depression overallStatus: COMPLETED date: 2022-03-01 date: 2022-10-31 date: 2022-10-31 date: 2024-03-22 date: 2024-03-22 name: Zhen-Hong Hu class: OTHER briefSummary: A total of 100 patients with adolescent depression who were admitted to our hospital between March 2022 and October 2022 were selected. On the basis of double blinding, these patients were randomly divided into the observation group(n=50) and the control group(n=50) using a random number table. 5S management method was used in the whole process of treatment to improve the hospital environment, increase the work efficiency and reduce the occurrence of cross infection through the effective implementation of the five steps of sort(Seiri), set in order(Seiton), shine (Seiso), standardize(Seiketsu) and sustain(Shitsuke). conditions: Adolescent Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 100 type: ACTUAL name: Bifidobacterium name: High-frequency rTMS name: Escitalopram Oxalate measure: HAMD-24 scores measure: TNF-α measure: IL-1β measure: IL-6 measure: DA measure: 5-HT measure: COR measure: Serum miR-16 measure: Serum miR-195 sex: ALL minimumAge: 13 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Tangshan Workers' Hospital city: Tangshan state: Hebei zip: 063003 country: China lat: 39.63333 lon: 118.18333 hasResults: False

 nctId: NCT06325592 id: REHSIL2023V1.1 briefTitle: Association Between Surgical Timing and Route of Total Hysterectomy After LEEP and Perioperative Risk in Patients With Cervical HSIL overallStatus: COMPLETED date: 2023-10-01 date: 2024-03-01 date: 2024-03-01 date: 2024-03-22 date: 2024-03-22 name: Sichuan Cancer Hospital and Research Institute class: OTHER briefSummary: This study aimed to analyze perioperative information in patients with high-grade squamous intraepithelial lesion (HSIL) undergoing total hysterectomy (TH), offering insights into optimal surgery timing, selecting the operation path, and enhancing surgical operation details. conditions: High-Grade Squamous Intraepithelial Lesions studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 826 type: ACTUAL name: surgical timing and operation path measure: Postoperative fever measure: Postoperative therapeutic use of antibiotics measure: Postoperative complications measure: Postoperative hospitalization days measure: Postoperative hemoglobin measure: Postoperative white blood cell count measure: Postoperative erythrocyte count measure: Postoperative albumin number measure: Postoperative CRP value sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Cancer Hospital and Research Institute city: Chengdu state: Sichuan zip: 610000 country: China lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06325579 id: AA29411356 briefTitle: Immersive Virtual Reality for Dysphagia acronym: IVRys overallStatus: COMPLETED date: 2021-05-24 date: 2023-02-28 date: 2023-03-31 date: 2024-03-22 date: 2024-03-25 name: Sheffield Hallam University class: OTHER briefSummary: People who have suffered a stroke are at high risk of suffering from oropharyngeal dysphagia with long and intensive exercise programmes. Early access to treatment and engaging therapies is very important for recovery. Immersive virtual reality technology presents an innovative treatment that could help patients improve swallowing. The aim of this study is to improve swallowing in stroke patients using two bespoke immersive virtual reality treatment with real-time feedback. The study consisted in a small feasibility study with stroke patients suffering dysphagia (n = 6, aged of 39 to 80 (M=71.17, SD=15.94). Results obtained through interviews with the patients indicated no discomfort reported during the game. All patients reported enjoying the game and feeling engaged and immersive and four out of six patients reported that they would like to use it every day as part of their Speech and Language therapy. The SALT assistant involved in the study stated that the system had the potential to encourage patients to swallow, being more functional than conventional speech therapy. She identified improvements needed for a better functioning of the VR rehabilitation system for Dysphagia. In a future study, wireless headsets will be used, without a laptop, and it will be important to improve the reliability and design of the strain gauge or innovate in the use of a different technology. conditions: Virtual Reality conditions: Dysphagia conditions: Treatment Compliance studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 6 type: ACTUAL name: Immersive Virtual Reality for Dysphagia Treatment measure: Feasibility of the system. Semi-structure Interviews with patients and staffs. Qualitative outcomes. measure: Feasibility of the system. Semi-structure Interviews with patients. Quantitative outcomes. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sheffield Hallam University city: Sheffield state: South Yorkshire zip: S1 2NU country: United Kingdom lat: 53.38297 lon: -1.4659 hasResults: False

 nctId: NCT06325566 id: MSB-DR004 briefTitle: Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain acronym: HyaluronicAcid overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-08 date: 2027-08 date: 2024-03-22 date: 2024-03-22 name: Mesoblast, Ltd. class: INDUSTRY briefSummary: The primary purpose of this study is to evaluate the efficacy of rexlemestrocel-L+HA compared to control in reducing low back pain at 12 months post-treatment and safety of a single injection of rexlemestrocel-L+HA injected into a lumbar intervertebral disc compared to control through 12 months post-treatment. conditions: Degenerative Disc Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: Rexlemestrocel-L + HA mixture name: Saline measure: Mean Change From Baseline in Daily Average Low Back Pain at 12 Months Post-treatment Based on Visual Analog Scale (VAS) Score measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Percentage of 30% VAS Pain Responders at 12 Months Post-treatment measure: Mean Change From Baseline in Quality of Life Measured by Euroqol-5D (EQ-5D) Index Score at 12 Months Post-treatment measure: Percentage of Minimal Pain Responders at 12 Months Post-treatment measure: Mean Change From Baseline in Function as Measured by Oswestry Disability Index (ODI) Questionnaire Score at 12 Months Post-treatment measure: Percentage of Participants With 30% VAS and 10-point ODI Treatment Success at 12 Months Post-treatment measure: Percentage of Participants Who Ceased Opioid Usage at 24 Months Post-treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06325553 id: 022_2566 briefTitle: Incidence of Platelet Refractoriness in Adult Acute Leukemia Patients Receiving Prestorage Filtered Blood and Comparing With Historical Control acronym: PTR overallStatus: RECRUITING date: 2024-03-30 date: 2025-03-30 date: 2026-03-30 date: 2024-03-22 date: 2024-03-22 name: Siriraj Hospital class: OTHER briefSummary: This research project is evaluate the incidence of platelet refractoriness in newly diagnosed acute leukemia patients receiving PFB during induction and first consolidation phase chemotherapy compared to 2 historical control groups which are patients receiving non-leukocyte depleted blood product group and leukocyte depleted blood product group and demonstrate cost-effectiveness of using blood products with filtered process to prevent clinical platelet refractoriness compare with using HLA-matched blood products after platelet refractoriness occurs conditions: Platelet Refractoriness in Adult Acute Leukemia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 252 type: ESTIMATED measure: Descriptive statistics measure: Inferential statistics 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: Phakaporn Chamweha, DR role: CONTACT phone: 06855156615 email: phakaporn.cham@gmail.com lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06325540 id: pulpcapping briefTitle: Clinical Success of Indirect Pulp Capping: 1-Year Follow-Up overallStatus: COMPLETED date: 2023-01-01 date: 2024-02-01 date: 2024-02-15 date: 2024-03-22 date: 2024-03-22 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: The goal of this clinical trial is to compare the clinical success of theracal pt, therabase, and biodentine indirect pulp capping on primary molars with deep dentin caries. Indirect pulp capping was used on the primary molars of the participants with deep dentin caries. It is aimed to compare the success of biodentine, which is considered the gold standard used in capping treatments, and the currently marketed Teracal PT and Therabase materials after 1, 6 months and 1 year, with biodentine and with each other, and find out which material is more successful. conditions: Dentin, Carious conditions: Indirect Pulp Capping studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Indirect pulp capping will be applied to primary molar teeth with deep dentin caries in 3 groups with 3 different materials(biodentine, thermal pt, therabase). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: patients and the researcher who evaluates the follow-up results of the patients will not know which material was used for indirect pulp coating. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 76 type: ACTUAL name: indirect pulp capping with theracal pt name: indirect pulp capping with therabase name: indirect pulp capping with biodentine measure: successful completion of research measure: unseccessful completion of research sex: ALL minimumAge: 5 Years maximumAge: 9 Years stdAges: CHILD facility: Sağlık Bilimleri Üniversitesi city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06325527 id: YuGarden-01 briefTitle: Cognitive Impairment Cohort Study of the Elderly Population in YuGarden overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2031-04-01 date: 2031-06-01 date: 2024-03-22 date: 2024-03-22 name: Ruijin Hospital class: OTHER briefSummary: The goal of this prospective observational research with an 8-year follow-up is to study the cognitive changes in the elderly in YuGarden community, Shanghai, China.

The main questions it aims to answer are:

* incidence of cognitive impairment in community (converting to mild cognitive impairment or Alzheimer's disease)
* to build a predictive model for the progression of cognitive impairment conditions: Alzheimer Disease conditions: Neurodegenerative Diseases conditions: Cognitive Impairment conditions: Mild Cognitive Impairment studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1872 type: ESTIMATED measure: Incidence of cognitive impairment measure: The change of Mini-Mental State Examination (MMSE) measure: The change of Barthel Index for Activities of Daily Living (ADL) measure: The change of blood biomarkers measure: The change of urine biomarkers measure: The change of feces biomarkers measure: The change of gingival crevicular fluid biomarkers measure: The change of electroencephalogram (EEG) measure: The change of speech information measure: The change of structural MRI measure: The change of functional MRI measure: The change of magnetic susceptibility measure: The change of perfusion MR imaging measure: Positron emission tomography (PET) sex: ALL minimumAge: 60 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine city: Shanghai state: Shanghai country: China name: Jinwen Xiao role: CONTACT phone: 13917310784 email: jw_xiao78@163.com name: Gang Wang role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06325514 id: NA2024 briefTitle: Artificial Intelligence Based Program to Classify Oral Cavity Findings Based on Clinical Image Analysis overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-01 date: 2024-09-01 date: 2024-03-22 date: 2024-03-26 name: Cairo University class: OTHER briefSummary: This study aims to develop an AI program that can classify oral findings into Normal/variation of normal or an oral disease by clinical photos analysis, aiding in lowering the percentages of false positive and false negative diagnosis of oral diseases. conditions: Oral Cancer conditions: Oral Lichen Planus conditions: Fordyce Granule conditions: Leukoplakia conditions: Erythroplakia conditions: Leukoedemas, Oral conditions: Lichenoid Reaction studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 241 type: ESTIMATED name: Artificial intelligence based program measure: risk stratification sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06325501 id: AA-2024-1 briefTitle: Misoprostol Versus Oxytocin Infusion On Reducing Blood Loss During Abdominal Myomectomy overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-01 date: 2025-01-01 date: 2024-03-22 date: 2024-03-22 name: Cairo University class: OTHER briefSummary: Uterine leiomyomas, or fibroids, are common benign tumors among women, especially those over 35 years old. They can cause various issues, including heavy menstrual bleeding, anemia, pelvic pain, and pressure symptoms. Surgery is often necessary for symptomatic fibroids, with hysterectomy recommended for women over 40 and myomectomy for those wishing to preserve their uterus. Myomectomy can be performed using different surgical approaches but can be associated with significant morbidity, particularly major blood loss, especially in abdominal myomectomy, where up to 20% of women may require blood transfusion.

Various interventions have been introduced to reduce bleeding during myomectomy, such as tourniquets, bupivacaine plus epinephrine infiltration, vasopressin injection, preoperative GnRH agonist administration, and preoperative ascorbic acid injection. However, these strategies may have complications, be ineffective, expensive, or require extra steps.

Oxytocin, primarily secreted from the pituitary gland, is crucial for uterine contraction during labor and delivery, and is used to prevent postpartum uterine atony and bleeding. However, caution is needed in its use, especially in women with heart disease or hypovolemia.

Misoprostol, a prostaglandin E1 analogue, can reduce bleeding during myomectomy by promoting myometrial contractions and reducing uterine artery blood flow. It can be administered via multiple routes, with rectal administration showing advantages in maintaining high plasma concentrations during surgery. Studies have investigated the effectiveness of single preoperative rectal doses of misoprostol versus preoperative oxytocin in reducing bleeding during abdominal myomectomy. conditions: Myoma;Uterus studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 56 type: ESTIMATED name: Misoprostol 200mcg Tab name: Oxytocin measure: intra-operative blood loss measure: blood transfusion measure: post-operative Hb measure: total surgery time sex: FEMALE minimumAge: 20 Years maximumAge: 48 Years stdAges: ADULT facility: faculty of medicine, Kasr el ainy hospital, Cairo university status: RECRUITING city: Cairo zip: 11562 country: Egypt name: Mohammad A Taymour, MD role: CONTACT phone: 01555761995 email: Mohammadtaymour@gmail.com name: Waleed M Elkhyat role: CONTACT phone: 01005135542 email: Waleed_elkhyat@yahoo.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06325488 id: H-23035668 briefTitle: Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease acronym: FORTIFY overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-01 date: 2025-06-01 date: 2024-03-22 date: 2024-03-22 name: Caroline Michaela Kistorp class: OTHER name: Sanofi briefSummary: The overall objective of this study is to investigate Fabry-associated renal organ involvement by using a novel magnetic resonance imaging (MRI) approach, focusing on changes in renal oxygen levels by blood oxygenation-level dependent (BOLD) imaging. Furthermore, to correlate renal oxygenation to the phenotypic presentation of patients with Fabry-associated nephropathy regarding circulating and imaging-derived biomarkers of kidney inflammation, fibrosis and injury as compared with healthy age- and sex-matched controls.

The study will achieve this by:

1) Using a non-invasive, contrast-free MRI protocol focusing on parameters of oxygenation, inflammation, fibrosis, and injury in the kidney.

2) Using an extensive, in-depth biomarker blood panel to investigate the pathological pathways associated with Fabry disease and Fabry-associated nephropathy. conditions: Fabry Disease conditions: Chronic Kidney Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: Renal hypoxia (Fabry patients according to renal impairment) measure: Renal hypoxia (Fabry patient vs controls) measure: Renal cortical perfusion (Fabry vs. controls) measure: Renal medullar perfusion (Fabry vs. controls) measure: Renal inflammation (Fabry vs. controls) measure: Renal fibrosis (Fabry vs. controls) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet city: Copenhagen zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-07-14 uploadDate: 2023-09-18T03:04 filename: Prot_000.pdf size: 808560 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-01-14 uploadDate: 2024-02-21T07:14 filename: SAP_001.pdf size: 1460496 hasResults: False

 nctId: NCT06325475 id: B.30.2.ATA.0.01.00/530 briefTitle: Comparison of Patients' Postpartum Recovery Using ObsQoR-10 Score in Pregnant Women in Vaginal Delivery With and Without Neuraxial Labor Analgesia overallStatus: RECRUITING date: 2024-03-26 date: 2024-07-26 date: 2024-08-26 date: 2024-03-22 date: 2024-03-22 name: Ataturk University class: OTHER briefSummary: The aim of this study was to compare the postpartum recovery of pregnant women who had vaginal delivery with and without neuraxial labor analgesia using the ObsQoR-10 scoring system. conditions: Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: labor with neuraxial labor analgesia name: labour without noroaxial labor analgesia measure: ObsQoR-10 scores of postpartum patients sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Atatürk University status: RECRUITING city: Erzurum country: Turkey name: Ayşenur Dostbil role: CONTACT phone: +905333677796 email: adostbil@hotmail.com lat: 39.90861 lon: 41.27694 hasResults: False

 nctId: NCT06325462 id: E2232/2023 briefTitle: The Influence of Anesthetic Technique on Cerebral Oxygenation During Spinal Surgery overallStatus: RECRUITING date: 2024-02-10 date: 2024-08 date: 2024-12 date: 2024-03-22 date: 2024-03-22 name: Prince Sultan Military Medical City class: OTHER briefSummary: Postural changes during anesthesia can lead to decreased cerebral blood flow and oxygenation, especially when moving from a supine to a prone position. This is particularly relevant during spinal surgery with controlled hypotension. Cerebral oximetry, monitored in the frontal cortex using an O3 sensor, is a noninvasive and continuous method to investigate the impact of anesthetic techniques on cerebral oxygenation in such scenarios. conditions: Cerebral Oxygenation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 54 type: ESTIMATED name: sensors of regional cerebral oxygen saturation (O3 regional oximeter, Masimo Corp, Irvine, CA) FDA Reg No. 3011353843 measure: regional cerebral oxygen saturation sex: ALL minimumAge: 18 Years maximumAge: 68 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prince Sultan Military Medical City status: RECRUITING city: Riyadh zip: 11159 country: Saudi Arabia name: Muteb AlOtaibi, M.D. role: CONTACT phone: 00966544793370 email: muteb612@gmail.com name: Rashid Al-Otaibi, M.D. role: SUB_INVESTIGATOR name: Osama Shalaan, M.D. role: SUB_INVESTIGATOR name: Muteb Al-Otaibi, M.D. role: SUB_INVESTIGATOR name: Majid Al-Sherif role: SUB_INVESTIGATOR lat: 24.68773 lon: 46.72185 hasResults: False

 nctId: NCT06325449 id: 5323 briefTitle: Correlating Improvement in PCOS Symptoms to the Percentage of Body Weight Lost in Females Also Living With Obesity acronym: FLOWERS-PCOS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-01 date: 2026-01-01 date: 2024-03-22 date: 2024-03-22 name: Ottawa Hospital Research Institute class: OTHER name: LEAF Weight Loss Clinic briefSummary: The goal of this clinical trial is to study the effects of a intensive weight loss program (STREAM) in patients living with PCOS. The main questions the investigators aim to answer are: how much weight will these patients lose over a 24-week program, and what other health markers (ie., insulin sensitivity) will improve and by how much?

Participants will complete a 24-week weight loss program (STREAM). During this program they will:

* weigh themselves
* complete regular bloodwork and
* fill out a Quality of Life questionnaire at regular intervals conditions: Polycystic Ovary Syndrome conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Clinic patients with PCOS will be recruited to participate in a 24-week weight loss program. They will all receive the program. There is no control group. primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: STREAM program measure: Weight loss measure: Change in Endocrine parameters (EP) as measure by blood test measure: Change in insulin sensitivity (IS) as measure by blood test measure: Change in Lipid profile (LP) as measure by blood test measure: Change in liver enzyme profile (LEP) as measure by blood test measure: Change in Menstrual Cyclicity measure: Quality of Life (QoL) Scale sex: FEMALE minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: LEAF Weight Management Clinic city: Ottawa state: Ontario zip: K1J9L3 country: Canada name: Judy Shiau, MD role: CONTACT phone: 613-701-1222 email: dr.shiau@leafwmc.ca name: Julie Laroche role: CONTACT phone: 613-701-1222 email: info@leafwmc.ca lat: 45.41117 lon: -75.69812 hasResults: False

 nctId: NCT06325436 id: scores in variceal bleeding briefTitle: Objective Scores in Variceal Bleeding overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-05-01 date: 2026-01-01 date: 2024-03-22 date: 2024-03-22 name: Assiut University class: OTHER briefSummary: To assess the prognostic performance of the ALBI associated scores (ALBI, PALBI and INR-ALBI score) and new MELD .3 in predicting the short-term outcomes (early re-bleeding and early mortality) of patients with cirrhosis presenting with acute variceal bleeding, comparable to the CTP and MELD and MELD Na scores. conditions: Variceal Hemorrhage studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 85 type: ESTIMATED measure: assess the prognostic performance of the ALBI_associated scores and new MELD .3 in predicting the short-term outcomes of patients with cirrhosis presenting with acute variceal bleeding. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06325423 id: response to NAC in MIBC briefTitle: Predicting Response to Neoadjuvant Chemotherapy in Muscle-invasive Bladder Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-06 date: 2027-06 date: 2024-03-22 date: 2024-03-26 name: Assiut University class: OTHER briefSummary: Bladder cancer (BC) is the 10th most commonly diagnosed cancer worldwide and the second most common cancer among Egyptian males.

The mainstay of treatment of muscle-invasive BC( MIBC) is neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) or bladder preservation(BP) using maximal transurethral resection of the bladder tumor followed by chemoradiation. The rationale to use NAC before RC or BP is to eradicate micro-metastasis and to downstage the primary tumor.

The 5-year cancer-specific survival for responders to NAC is 90%, in contrast to 30-40% for those not obtaining an objective response. Drawbacks of NAC are disappointing delay of surgery in non-responders and the potential toxicity. So, predictors of response to NAC are necessary to identify patients who may achieve pathologic complete response and will benefit from BP, and the others who may not respond to NAC and spare them NAC toxicity and RC delay.

Tumor microenvironment (TME), including neutrophil extracellular traps (NETs), and CD8+ T lymphocytes is a promising predictor of response to NAC in MIBC.

NETs are reticulated DNA structures decorated with various protein substances (e.g., histones, myeloperoxidase, neutrophil elastase).NETs are involved in tumor growth, metastasis, and treatment resistance. Moreover, NETs can inhibit T cell responses, thereby promoting tumor growth.

On the other hand, immune cells that are present in the TME play a major role in slowing down tumor progression. CD8+T lymphocytes play a central role in immune-mediated control of cancer . Also, they have been found to be a prognostic tool for advanced BC. conditions: Muscle-Invasive Bladder Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 50 type: ESTIMATED name: neoadjuvant chemotherapy measure: Evaluation of the expression of NETs and CD8 in paraffin-embedded TUR biopsies measure: - Response to platinum-based chemotherapy in localized MIBC in relation to: NETs expression, CD8 expression, NET/CD8 ratio and baseline clinicopathological features measure: Local recurrence-free survival (RFS) sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06325410 id: #11279-20-11-2023 briefTitle: Prognostic Factors Influencing the Recurrence Rate and Survival of Patients With Colorectal Cancer: a Single Institution Experience overallStatus: COMPLETED date: 2013-01 date: 2022-12 date: 2022-12 date: 2024-03-22 date: 2024-03-22 name: Zagazig University class: OTHER_GOV briefSummary: over the past decade colon cancer has emerged as the second most deadly and the third most common type of cancer in the world with increasing incidence in Egypt due to life style and diet change. some research showed relation between colon cancer recurrence and advanced tumor staging. To investigators knowledge, this is the first time to be done in Zagazig University.

Data was collected from records in a retrospective cohort study conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ACTUAL name: resection of colorectal cancer measure: age measure: sex measure: medical disease measure: previous surgery measure: CEA measure: tumor grade measure: tumor site measure: tumor size measure: surgical margins of resected tumor measure: neoadjuvant therapy measure: adjuvant therapy measure: diet measure: occupation measure: family history measure: type of surgery(laparoscopic or open) measure: soiling by during surgery measure: hand sewen or stappled anastmosis measure: post operative complications measure: site of recurrence measure: type of resected tumor sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zagazig University Hospitals city: Zagazig zip: 44519 country: Egypt lat: 30.58768 lon: 31.502 hasResults: False

 nctId: NCT06325397 id: IIT #88313865 briefTitle: Less Discomfort and Less Pharmacology. Cataract Surgery at Physiologic Intraocular Pressure (IOP) overallStatus: RECRUITING date: 2023-10-23 date: 2024-04 date: 2024-06 date: 2024-03-22 date: 2024-03-22 name: Matthew Rauen class: OTHER briefSummary: To investigate the impact of high vs low Intraocular Pressure (IOP) on the intraoperative experience for the patient and surgeon. Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication conditions: Nuclear Cataract studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 75 type: ESTIMATED name: High Intraocular Pressure (IOP) name: Low Intraocular Pressure (IOP) measure: Medication Rescue measure: Physiologic Responses associated with pain/inflammation: measure: Physiologic Responses associated with pain/inflammation: measure: Surgeon Experience: Assessment on patient cooperation measure: Surgeon Experience: Surgeon intraoperative experience measure: Cost- analysis sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Wolfe Eye Clinic status: RECRUITING city: West Des Moines state: Iowa zip: 50266 country: United States name: Robyn Kohler, RN role: CONTACT phone: 515-223-8685 phoneExt: 2305 email: rkohler@wolfeclinic.com name: Hillery Joiner role: CONTACT phone: 5152238685 phoneExt: 2085 email: hjoiner@wolfeclinic.com name: Matthew Rauen, MD role: PRINCIPAL_INVESTIGATOR lat: 41.57721 lon: -93.71133 hasResults: False

 nctId: NCT06325384 id: IRAS ID:1008701 briefTitle: Real World Evaluation of Lifelight®: A Contactless Vital Signs Monitor for Self-monitoring Blood Pressure and Its Comparison to Standard of Care acronym: VISION-RWE overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-08-31 date: 2025-08-31 date: 2024-03-22 date: 2024-03-22 name: Xim Limited class: INDUSTRY name: Barts & The London NHS Trust name: Mind Over Matter Medtech Ltd name: Health Innovation Wessex briefSummary: A randomised controlled trial for comparison of real-world feasibility and clinical outcomes of two different methods of home blood pressure monitoring Participants aged 18 years or over with diagnosed and treated hypertension (including via lifestyle interventions) that is not controlled (i.e. in-clinic measurement is 140/90 mmHg or greater) will be recruited from hypertension hospital clinics conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 500 type: ESTIMATED name: Lifelight name: Blood Pressure Cuff measure: Blood Pressure Measurement Non Inferiority measure: Adherance to Blood Pressure Measurement sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06325371 id: 0028201 briefTitle: Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2 acronym: DEDICATE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-06-30 date: 2025-06-30 date: 2024-03-22 date: 2024-03-22 name: University of Turin, Italy class: OTHER briefSummary: This is a multicentric voluntary observational study with a retrospective evaluation of prospectively collected data concerning the treatment of visceral aneurysms with flow diversion stent Derivo Peripher and Derivo 2 (DED, Acandis GmbH) Follow-up will include clinical and radiological (CT) evaluation at least 12 months after the intervention.

The enrollment period will be of 54 months (01/01/2020-30/06/2024). Minimum sample size will be of 50 Patients. conditions: Aneurysm Abdominal conditions: Arterial Aneurysm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: Visceral aneurysm stenting measure: Efficacy of the stenting in terms of patency and side branches measure: Efficacy of the stenting in terms of aneurysm thrombosis rate measure: Efficacy of the stenting in terms of aneurysm volume assessment measure: Safety in terms of morbidity measure: Safety in terms of mortality measure: Safety in terms of technical issues sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06325358 id: 0040083/23 briefTitle: the EXPOSITION Study acronym: EXPOSITION overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-30 date: 2024-12-30 date: 2024-03-22 date: 2024-03-22 name: University of Pavia class: OTHER name: National Research Council (Consiglio Nazionale delle Ricerche) name: IRCCS National Neurological Institute "C. Mondino" Foundation briefSummary: This is a cross-sectional study to evaluate the variation of biological biomarkers of oxidative stress and inflammation in response to the external exposome, in people with Multiple Sclerosis (pwMS).The objective is to study the variation of biological biomarkers of oxidative stress and inflammation in response to external exposome in pwMS, controlling for other biomarkers (cytokine, neurofilaments, microbiome), gender, age, anthropometric measurements, vitamin D levels and medical history. Specifically, the variation of microRNAs is defined as the primary outcome, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome. Following the functional exposome approach:(1)Information on a pwMS sample about socio-demographic characteristics and medical history will be collected and specific components of the (2) On the same pwMS sample, the internal exposome variation will be measured. MicroRNA levels and gut and nasal microbiota alpha- and beta-diversity and relative bacterial abundances will be considered as biomarkers of oxidative stress and inflammation. At the same time, cytokines and neurofilament proteins (NfL) will be measured as biomarkers of neurodegeneration and axonal damage. Adults (≥ 18 years) pwMS, with relapsing-remitting course, diagnosis of MS according to 2017 McDonald criteria and residing in Pavia or Milan (Italy) will be included. Potentially eligible pwMS will be screened by a neurologist expert in MS who will verify that all the inclusion criteria will be fulfilled. To validate variation among 7 selected MS diagnostic miRNA, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome, the differential expression (ΔCT) for each miRNA will be considered as the outcome measure. Two hundred eligible pwMS who meet the inclusion criteria and sign the informed consent will be included in the study, to consider 15% dropout at the blood sampling stage. conditions: Multiple Sclerosis, Relapsing-Remitting conditions: Environmental Exposure conditions: Lifestyle Factors studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED measure: microRNAs measure: Air quality measure: Nutritional assessment measure: Neurofilament (NfL) measure: Cytokines measure: the Body Mass Index (BMI) measure: Physical activity measure: Quality of life related to MS measure: Sleep Quality measure: Smoking habits measure: Dietary supplements use measure: Adherence to Mediterranean diet measure: Effect of diet on inflammation measure: waist and height ratio (WHtR) measure: Bioelectrical impedance measure: Microbiome and biological biomarkers of oxidative stress and inflammation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Foundation C. Mondino city: Pavia zip: 27100 country: Italy name: Eleonora Tavazzi role: CONTACT phone: 0382 380403 phoneExt: +39 email: eleonora.tavazzi@mondino.it name: Roberto Bergamaschi role: SUB_INVESTIGATOR name: Eleonora Tavazzi role: PRINCIPAL_INVESTIGATOR name: Hellas Cena role: SUB_INVESTIGATOR name: Rachele de Giuseppe role: SUB_INVESTIGATOR name: Beatrice Maccarini role: SUB_INVESTIGATOR name: Aliki Kalmpourtzidou role: SUB_INVESTIGATOR name: Elena Colombo role: SUB_INVESTIGATOR name: Eleonora Rigoni role: SUB_INVESTIGATOR name: Lara Ahmad role: SUB_INVESTIGATOR name: Monica Bianchi role: SUB_INVESTIGATOR name: Veronica Tosca role: SUB_INVESTIGATOR name: Luciana Gracardi role: SUB_INVESTIGATOR name: Romina Sarchi role: SUB_INVESTIGATOR name: Anna Scarabotto role: SUB_INVESTIGATOR name: Matteo Gastaldi role: SUB_INVESTIGATOR name: Ghanya Al-Naqeb role: SUB_INVESTIGATOR name: Federica Loperfido role: SUB_INVESTIGATOR name: Mulubirhan A. Alemayohu role: SUB_INVESTIGATOR name: Maria Cristina Monti role: SUB_INVESTIGATOR name: Cristina Montomoli role: SUB_INVESTIGATOR name: Danilo Porro role: SUB_INVESTIGATOR name: Gloria Bertoli role: SUB_INVESTIGATOR name: Alessia Lo Dico role: SUB_INVESTIGATOR name: Clarissa Consolandi role: SUB_INVESTIGATOR name: Marco Severgnini role: SUB_INVESTIGATOR name: Francesca Costabile role: SUB_INVESTIGATOR name: Stefano Decesari role: SUB_INVESTIGATOR lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06325345 id: 22-5277 briefTitle: RCT of Gut-directed Hypnotherapy in Ehlers-Danlos Syndromes and Generalized Hypermobility Spectrum Disorders overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-29 date: 2025-04-01 date: 2024-03-22 date: 2024-03-22 name: University Health Network, Toronto class: OTHER briefSummary: This randomized, controlled trial (RCT) will evaluate the effectiveness of gut-directed hypnotherapy for management of Irritable Bowel Syndrome (IBS) in individuals diagnosed with Ehlers-Danlos Syndromes or Generalized Hypermobility Spectrum Disorders (G-HSD). Consenting patients recruited from the Toronto General Hospital GoodHope Ehlers-Danlos Syndrome Clinic will be randomly assigned to one of two groups: (1) standard medical therapy or (2) standard medical therapy plus eight sessions of gut-directed hypnotherapy. The main questions this study will answer are:

1. Is gut-directed hypnotherapy an efficacious treatment for IBS symptoms among individuals with EDS or G-HSD?
2. Does gut-directed hypnotherapy improve other gut symptoms, quality of life, visceral sensitivity, and emotional distress?
3. Is the activity of the parasympathetic nervous system (i.e. the body's "rest and digest" system) associated with IBS symptoms or treatment outcomes among individuals with EDS or G-HSD?

All participants will be asked to meet with a gastroenterologist three times as part of the standard medical therapy. At each physician visit, they will undergo electrocardiogram recording and complete self-report measures of gastrointestinal symptoms, quality of life, visceral sensitivity, and emotional distress. Participants randomized to receive gut-directed hypnotherapy will also eight weekly remotely-delivered sessions of gut-directed hypnotherapy delivered by a trained behavioral therapist in between the first and second physician visit. At each session of gut-directed hypnotherapy, a voluntary, pleasant, and dream-like state of deep relaxation will be induced and suggestions made for greater relaxation, abdominal comfort, and normalization of gut function. The first session will also include 30 minutes of education on the nature of the gut-brain axis and hypnotherapy prior to hypnosis.

Researchers will compare study groups to see if participants who engaged in gut-directed hypnotherapy had greater improvement in IBS symptoms, other gastrointestinal symptoms, quality of life, visceral sensitivity, and emotional distress. Exploratory analyses will examine the relationships among heart rate variability, an index of parasympathetic nervous system activity, and study outcomes. conditions: Ehlers-Danlos Syndrome conditions: Irritable Bowel Syndrome conditions: Hypermobility Syndrome conditions: Gastrointestinal Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 74 type: ESTIMATED name: Gut-directed hypnotherapy name: Standard Medical Therapy measure: IBS Symptom Severity measure: Upper Gastrointestinal Symptoms measure: IBS-related Quality of Life measure: Visceral Sensitivity measure: Emotional Distress measure: Weekly Ratings of GI Health and Medication Use sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Toronto General Hospital city: Toronto state: Ontario zip: M5G 2C4 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06325332 id: RSV00080 briefTitle: BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study) acronym: BEAR overallStatus: RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-03-22 date: 2024-04-08 name: Sanofi Pasteur, a Sanofi Company class: INDUSTRY briefSummary: The primary objectives of the study are: To estimate the effectiveness of nirsevimab against polymerase chain reaction (PCR)-confirmed RSV (1) lower respiratory tract (LRTD) and (2) related medical encounters.

the secondary objectives are:

1. To estimate the effectiveness of nirsevimab against medical encounters with a respiratory related diagnosis.
2. To estimate the effectiveness of nirsevimab against medical encounters with an LRTD diagnosis.
3. To estimate the impact of nirsevimab on PCR-confirmed RSV.
4. To estimate the impact of nirsevimab on medical encounters with an otitis media diagnosis.
5. To estimate the impact of nirsevimab on antibiotic prescription. conditions: Respiratory Syncytial Virus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 33000 type: ESTIMATED name: Nirsevimab measure: Incidence of first episodes of polymerase chain reaction (PCR)-confirmed RSV with an lower respiratory tract disease (LRTD) measure: Number of medical encounters associated with the first episode of PCR-confirmed RSV with a LRTD diagnosis measure: Number of respiratory-related medical encounters measure: Number of respiratory-related medical encounters for LRTD by ICD-10 codes measure: Incidence of PCR-confirmed RSV (first occurrence of season) measure: Number of medical encounters for otitis media by ICD-10 codes measure: Number of antibiotic prescriptions by National Drug Code (NDC) codes sex: ALL minimumAge: 0 Days maximumAge: 12 Months stdAges: CHILD facility: Kaiser Permanente Northern California: Site number 0001 status: RECRUITING city: Oakland state: California zip: 94612 country: United States lat: 37.80437 lon: -122.2708 hasResults: False

 nctId: NCT06325319 id: Ref. No. MA.84/261/02/1/115 briefTitle: Effect of Community Engagement Using M-Mama Champions overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-04 date: 2024-05 date: 2024-03-22 date: 2024-03-22 name: University of Dodoma class: OTHER name: Stephen Kibusi name: James Tumaini Kengia briefSummary: This study aims to determine the effectiveness of community engagement using M-MAMA Champions on awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women in Bahi, Dodoma. This is a community-based, cluster randomized controlled trial (cRCT) study, whereby 120 first and second-trimester pregnant women will be randomized at a ratio of 1:1 to the intervention and control groups. The intervention of sensitizing pregnant women on Obstetric danger signs, birth preparedness, and complication readiness by the empowered M-MAMA Champions to the intervention arm clusters will be done for one month, a two-hour session will be delivered every two weeks, using participatory learning and action model for women groups to test the effectiveness of M-MAMA Champions in improving literacy level of obstetric danger signs, birth preparedness and complication readiness and its practice among pregnant women.

The following is the hypothesis being tested

Null Hypothesis; There is no difference in improvement of awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women when community engagement is done using M-MAMA Champions compared to routine approaches.

Alternative hypothesis; Community engagement using M-MAMA Champions to improve awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women is more effective than routine approaches.

During each 2-hour session, five (5) women will gather up and discuss the obstetric danger signs, birth preparedness, and complication readiness with the assistance of the M-MAMA Champion as a facilitator. An approved brochure on the concerned subject will be used for sensitization. Baseline data will be collected before and after the intervention.

The control arm won't receive any intervention. conditions: Obstetric Complication conditions: Woman's Role studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Community engagement using M-MAMA Champions to improve awareness on obstetric danger signs, bith preparedness and complication readiness among pregnant women measure: Improvement in scores from a semi-structured interviewer-administered questionnaire on awareness of obstetric danger signs among pregnant women. measure: Improvement in scores from a semi-structured interviewer-administered questionnaire of awareness of birth preparedness and complication readiness among pregnant women measure: Improvement in scores from a semi-structured interviewer-administered questionnaire on reported practice of birth preparedness and complication readiness sex: FEMALE minimumAge: 15 Years maximumAge: 49 Years stdAges: CHILD stdAges: ADULT facility: University of Dodoma city: Dodoma zip: 259 country: Tanzania name: Alex P Sanga, MSc. PH role: CONTACT phone: 0762144082 email: sanga.alex@gmail.com name: Stephen Kibusi, PhD role: CONTACT phone: 0712600966 email: skibusi@gmail.com lat: -6.17221 lon: 35.73947 hasResults: False

 nctId: NCT06325306 id: 2023/392 id: B7072023000102 type: OTHER domain: Comité d'Ethique Hospitalo-Facultaire Universitaire de Liège briefTitle: Physical Literacy-Based Intervention for Chronic Disease Management overallStatus: RECRUITING date: 2024-03-04 date: 2024-10-30 date: 2024-10-30 date: 2024-03-22 date: 2024-03-22 name: University of Liege class: OTHER name: Centre Hospitalier Universitaire de Liege briefSummary: The goal of this quasi-experimental study is to evaluate the effectiveness of a physical literacy-based intervention for chronic disease management in adults with chronic diseases participating in adapted physical activity group sessions in Belgium. The main questions it aims to answer are:

* How does incorporating physical literacy elements in adapted physical activity sessions affect participants overall physical literacy levels?
* Can a physical literacy-oriented adapted physical activity program enhance long-term engagement in physical activities and improve health outcomes for chronic disease patients?

Participants will:

* Undergo assessments for physical literacy levels and health outcomes at the beginning, after three months, and at the end of the six-month period.
* Engage, in intervention groups, in adapted physical activity sessions, which may include physical fitness exercises and educational components on physical literacy.

Researchers will compare 3 groups: a control group, a traditional Adapted Physical Activity (APA) group, and a Physical Literacy Oriented APA (APA+PL) group to see if integrating physical literacy components results in improved physical literacy levels, better sustained engagement in physical activities, and enhanced health outcomes. conditions: Chronic Disease conditions: Chronic Disease Management conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 195 type: ESTIMATED name: Traditional APA name: APA+PL measure: Global Physical Literacy Score measure: Physical Activity Behavior and Engagement measure: Motivation and Confidence in Physical Activity measure: Physical Competence measure: Knowledge and Understanding of Physical Activity measure: Environment interactions measure: Meaningful and Purposeful Activities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Sportif du Sart-Tilman status: RECRUITING city: Liège zip: 4000 country: Belgium name: Jean-Pierre Weerts, M.A. role: CONTACT phone: +32 4366 3818 email: jpweerts@uliege.be name: Cédric Lehance, M.A. role: CONTACT phone: +32 477490055 email: clehance@chuliege.be name: Jean-Pierre Weerts, M.A. role: PRINCIPAL_INVESTIGATOR lat: 50.63373 lon: 5.56749 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-02 uploadDate: 2024-03-08T06:13 filename: ICF_000.pdf size: 334181 hasResults: False

 nctId: NCT06325293 id: 2023-01295 id: 207286 type: OTHER_GRANT domain: Swiss National Science Foundation briefTitle: A Trial of Placebo Versus Macrolide for Mycoplasma Pneumoniae Childhood Pneumonia: MYTHIC Study acronym: MYTHIC overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2028-06-30 date: 2028-06-30 date: 2024-03-22 date: 2024-03-22 name: Christoph Berger class: OTHER briefSummary: The goal of this clinical trial is to compare a placebo (a look-alike substance that contains no active drug) with a commonly used antibiotic in children with Mycoplasma pneumoniae (a specific bacterium) induced community-acquired pneumonia. The main question it aims to answer is:

Is antibiotic treatment needed in Mycoplasma pneumoniae (a specific bacterium) induced pneumonia?

Participants will receive either a placebo or a antibiotic treatment and track their symptoms and vital signs until they are healthy.

Researchers will then compare the length of symptoms between the placebo and the antibiotic group. conditions: Community Acquired Pneumonia in Children conditions: Mycoplasma Pneumoniae conditions: Mycoplasma Pneumoniae Pneumonia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomized, double-blind, placebo-controlled, multicenter, non-inferiority trial. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 376 type: ESTIMATED name: Azithromycin Pfizer® name: Placebo measure: Co-primary outcome: days to normalization of all vital signs measure: Co-primary outcome: community-acquired pneumonia(CAP)-related change in patient care status measure: Overall clinical outcome measure: Time (days) to normalization of CAP-related symptoms measure: Quality of Life (QoL) Assessment assessing impact of the child's pneumonia on the family's social and health-related well-being measure: Time (days) to return to daily routine measure: Incidence of Mp-associated extrapulmonary manifestations development in patients assessed by clinical examination and/or parent report measure: Length of hospital stay (LOS) measure: Number of unscheduled medical visits measure: Proportion of patients (re-)treated with antibiotics for any reason measure: Side effects/AEs/serious AE (SAE)s of investigational medicinal product (IMP) measure: Microbiological indicators sex: ALL minimumAge: 3 Years maximumAge: 17 Years stdAges: CHILD facility: Children's Hospital Aarau, Switzerland city: Aarau state: Aargau zip: 5001 country: Switzerland name: Henrik Köhler, Prof. Dr. med. role: CONTACT phone: 0041 62 838 41 41 email: Henrik.Koehler@ksa.ch name: Henrik Köhler, Prof. Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 47.39254 lon: 8.04422 facility: University of Basel Children's Hospital, Switzerland city: Basel state: Basel-Stadt zip: 4056 country: Switzerland name: Julia A Bielicki, PD Dr. Dr. med. role: CONTACT phone: 0041 61 704 12 12 email: julia.bielicki@ukbb.ch name: Julia A Bielicki, PD Dr. Dr. med. role: PRINCIPAL_INVESTIGATOR name: Ulrich Heiniger, Prof. Dr. med. role: SUB_INVESTIGATOR lat: 47.55839 lon: 7.57327 facility: Department of Pediatrics, Cantonal Hospital Graubuenden, Switzerland city: Chur state: Graubünden zip: 7000 country: Switzerland name: Beate Deubzer, Dr. med. role: CONTACT phone: 0041 81 256 61 11 email: beate.deubzer@ksgr.ch name: Beate Deubzer, Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 46.84986 lon: 9.53287 facility: Children's Hospital of Eastern Switzerland St. Gallen city: St. Gallen state: Saint Gallen zip: 9006 country: Switzerland name: Anita Niederer-Loher, Dr. med. role: CONTACT phone: 0041 71 243 71 11 email: anita.niederer@kispisg.ch name: Anita Niederer-Loher, Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 47.42391 lon: 9.37477 facility: Institute of Pediatrics of Southern Switzerland, EOC, Bellinzona, Switzerland city: Bellinzona state: Ticino zip: 6500 country: Switzerland name: Lisa Kottanattu, Dr. med. role: CONTACT phone: 0041 91 811 91 11 email: Lisa.Kottanattu@eoc.ch name: Lisa Kottanattu, Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 46.19278 lon: 9.01703 facility: Department of Pediatrics, Department Mother-Woman-Child, Lausanne University Hospital, Switzerland city: Lausanne state: Vaud zip: 1011 country: Switzerland name: Ludivine Coulon, Dr. med. role: CONTACT phone: 0041 21 314 11 11 email: Ludivine.Coulon@chuv.ch name: Ludivine Coulon, Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 46.516 lon: 6.63282 facility: Department of Pediatrics, Cantonal Hospital Winterthur, Switzerland city: Winterthur state: Zurich zip: 8401 country: Switzerland name: Andreas Jung, Dr. med. role: CONTACT phone: 0041 52 266 41 44 email: andreas.jung@ksw.ch name: Andreas Jung, Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 47.50564 lon: 8.72413 facility: University Children's Hospital Bern, Switzerland city: Bern zip: 3010 country: Switzerland name: Philipp Agyeman, PD Dr. med. role: CONTACT phone: 0041 31 632 21 11 email: Philipp.Agyeman@insel.ch name: Philipp Agyeman, PD Dr. med. role: PRINCIPAL_INVESTIGATOR name: Kristina Keitel, PD Dr. Dr. med. role: SUB_INVESTIGATOR lat: 46.94809 lon: 7.44744 facility: Department of Pediatrics, Fribourg Hospital, Switzerland city: Fribourg zip: 1708 country: Switzerland name: Petra Zimmermann, PD Dr. Dr. med. role: CONTACT phone: 0041 26 306 00 00 email: petra.zimmermann@unifr.ch name: Petra Zimmermann, PD Dr. Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 46.80237 lon: 7.15128 facility: Children's Hospital of Geneva, University Hospitals of Geneva, Switzerland city: Geneva zip: 1205 country: Switzerland name: Noémie Wagner, Dr. med. role: CONTACT phone: 0041 22 372 40 00 email: Noemie.Wagner@hcuge.ch name: Noémie Wagner, Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 46.20222 lon: 6.14569 facility: Children's Hospital of Central Switzerland, Switzerland city: Luzern zip: 6000 country: Switzerland name: Alex Donas, Dr. med. role: CONTACT phone: 0041 41 205 31 66 email: alex.donas@luks.ch name: Alex Donas, Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 47.05048 lon: 8.30635 facility: University Children's Hospital Zurich, Switzerland city: Zurich zip: 8032 country: Switzerland name: Michelle Seiler, PD Dr. med role: CONTACT phone: 0041 44 266 71 11 email: Michelle.Seiler@kispi.uzh.ch name: Michelle Seiler, PD Dr. med role: PRINCIPAL_INVESTIGATOR lat: 47.36667 lon: 8.54999 facility: Department of Pediatrics, Triemli Hospital Zurich, Switzerland city: Zurich zip: 8063 country: Switzerland name: Maren Tomaske, Prof. Dr. med. role: CONTACT phone: 0041 44 416 11 11 email: Maren.Tomaske@stadtspital.ch name: Maren Tomaske, Prof. Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 47.36667 lon: 8.54999 hasResults: False

 nctId: NCT06325280 id: Pro00132542 briefTitle: Exercise MRI to Evaluate Cardiorespiratory Fitness in Children With Heart Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2027-12-31 date: 2024-03-22 date: 2024-03-22 name: University of Alberta class: OTHER briefSummary: There are many barriers to heart-healthy lifestyles in pediatric patients with acquired and congenital heart disease. Investigators want to further understand how participants heart and skeletal muscles work together during exercise and evaluate the impact on cardiac function. To do this, the investigators will use magnetic resonance imaging (MRI) to scan the heart and skeletal muscles during exercises to assess blood flow, oxygenation and function. conditions: Pediatric ALL conditions: Congenital Heart Disease conditions: Heart Transplantation studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Exercise cardiac MRI Assessment name: Cardiopulmonary Exercise Test measure: MRI assessment of cardiac structure at rest measure: MRI assessment of cardiac function at rest measure: Maximal exercise MRI assessment of cardiac structure measure: Cardioplumonary Exercise Test sex: ALL minimumAge: 10 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: University of Alberta city: Edmonton state: Alberta zip: T6G 2B7 country: Canada name: Rae Foshaug role: CONTACT phone: 780-407-7499 email: rae.foshaug@albertahealthservices.ca name: Michael Khoury, MD role: CONTACT phone: 780-492-0103 email: khoury1@ualberta.ca name: Michael Khoury, MD role: PRINCIPAL_INVESTIGATOR lat: 53.55014 lon: -113.46871 hasResults: False

 nctId: NCT06325267 id: PLC briefTitle: Clinical Characteristics of Primary Liver Cancer overallStatus: RECRUITING date: 2010-01-01 date: 2024-08-31 date: 2024-08-31 date: 2024-03-22 date: 2024-03-27 name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School class: OTHER briefSummary: Primary liver cancer (PLC) is the sixth most common malignancy in the world and the third most common cause of malignancy death. In 2020, there were about 905,677 new cases of PLC worldwide, and 830,180 deaths. Despite the availability of a variety of treatments for PLC, the 5-year net survival rate is still only 5% to 30%. How to effectively reduce the disease burden of PLC is a major public health problem that needs to be solved worldwide. The clinical characteristics and prognosis of PLC caused by different pathogenic factors are different. Therefore, it is of great significance to fully identify the risk factors of PLC, be familiar with the clinical characteristics and prognosis of disease development, and understand the relevant monitoring and follow-up strategies for the prevention and treatment of PLC. conditions: Primary Liver Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED measure: Epidemiological characteristics of overall cohort by liver disease etiology measure: Clinical characteristics of overall cohort by liver disease etiology measure: Survival rates of overall cohort and different etiologies measure: Risk factors of prognosis in overall cohort and different etiologies sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing Drum Tower Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210008 country: China name: Jie Li, M.D., Ph.D role: CONTACT phone: 15863787910 email: lijier@nju.edu.cn lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06325254 id: MAFLD briefTitle: Clinical Characteristics of Metabolic Associated Fatty Liver Disease overallStatus: RECRUITING date: 2010-01-01 date: 2024-08-31 date: 2024-08-31 date: 2024-03-22 date: 2024-03-26 name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School class: OTHER briefSummary: Metabolic associated fatty liver disease (MAFLD), which can lead to liver fibrosis, cirrhosis, liver failure and even hepatocellular carcinoma, poses a significant burden on society. With the improvement of living standards and changes in dietary habits, MAFLD patients show a younger and increasing trend, but there is still no specific drug. The clinical features and prognosis of MAFLD may be different with different metabolic disorder phenotypes and treatment measures. Therefore, further systematic study of the clinical characteristics and prognosis of MAFLD patients will be of great significance for the formulation of corresponding clinical prevention and treatment strategies. conditions: Metabolic Associated Fatty Liver Disease conditions: Clinical Features studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3000 type: ESTIMATED measure: Clinical characteristics and follow-up outcomes of MAFLD patients measure: Clinical characteristics and follow-up outcomes of MAFLD patients under different subgroups measure: Baseline clinical characteristics MAFLD patients measure: Risk factors for progression to cirrhosis and hepatocellular carcinoma sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing Drum Tower Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210008 country: China name: Jie Li, M.D.,Ph.D role: CONTACT phone: 15863787910 email: lijier@nju.edu.cn lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06325241 id: 20200048-01H briefTitle: Validating the Use of Frailty Measurements to Predict Care & Quality of Life overallStatus: ACTIVE_NOT_RECRUITING date: 2022-12-12 date: 2025-03-31 date: 2025-03-31 date: 2024-03-22 date: 2024-04-24 name: Ottawa Hospital Research Institute class: OTHER briefSummary: The aim of this research program is to validate frailty measurements as a risk stratification tool to predict deteriorations in patient-reported outcomes, to gain a better understanding of patient preferences for care within varying degrees of frailty, and to assess differences in frailty measurement between patients and their clinicians.

This work will provide a foundation in the development of customized interventions for people with COPD and varying degrees of frailty, with the goal of improving quality of life and optimizing health system service delivery for patients and their care givers. conditions: Chronic Obstructive Pulmonary Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 123 type: ACTUAL name: No intervention measure: Respiratory Health Related Quality of Life measure: Burden of symptoms - COPD Assessment measure: Burden of symptoms - Dyspnea measure: Psycho-social well being - Anxiety measure: Psycho-social well being - Depression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Ottawa Hospital, General Campus city: Ottawa state: Ontario zip: K1J 0J2 country: Canada lat: 45.41117 lon: -75.69812 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2022-09-22 uploadDate: 2022-11-29T13:05 filename: Prot_SAP_000.pdf size: 617838 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form: Verbal consent date: 2022-11-09 uploadDate: 2022-11-29T13:08 filename: ICF_001.pdf size: 317754 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form: English Information Sheet date: 2022-11-09 uploadDate: 2022-11-29T13:11 filename: ICF_002.pdf size: 161773 hasResults: False

 nctId: NCT06325228 id: NKBBN/241/2023 id: SONP/SP/549693/2022 type: OTHER_GRANT domain: Minister of Education and Science briefTitle: Musculoskeletal Injuries, Sports Performance, Sports Specialization, and Quality of Life in Young Athletes overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-01 date: 2025-05-01 date: 2025-09-01 date: 2024-03-22 date: 2024-04-24 name: Medical University of Gdansk class: OTHER name: Ministry of Science and Higher Education, Poland briefSummary: The primary aim of this observational cohort study is to assess sports specialization, sports performance, history of injuries (prevalence, types, areas, duration) and quality of life in young healthy athletes aged 8-16 from Poland. Athlete profiles will be created based on the variables (explained in detailed description) examined. Furthermore, the investigators will perform one-year injury follow-up.

The main questions it aims to answer are:

* Do athletes with a specific profile (lower values in athletic performance tests, low values in quality of life) evaluated at one time point, suffer injury in the future in annual observation?
* Do athletes with high sports specialization will sustain injury in one-year follow-up?
* Does sports specialization have a relationship with sports performance tests, and quality of life?
* Does sport specialisation, training volume, geographical factor relate to injury history?
* Does sports specialisation, injury history differ between sports (individual and team sports)?
* Does value of the specific muscle (lower limb) isometric strength will be associated with the dynamic balance scores in young healthy athletes? conditions: Sport Injury conditions: Healthy conditions: Injury;Sports conditions: Quality of Life studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 373 type: ACTUAL measure: Number of Participants with sports injury after one-year follow-up measure: Type, location, duration, and return to sports in participants with injury at one-year follow up measure: Sports Specialization measure: History of sports-related injuries measure: Health-related quality of life: EQ-5D-Y measure: Y-Balance Test - dynamic balance test measure: Functional Movement Screen (FMS) measure: Hand-Held Dynamometer (HHD) measurement - Isometric Strength of the lower extremities muscle measure: Sport workload (hours per trainings or competition) measure: Peak Height Velocity measure: Sports discipline and position measure: Participants characteristics - Body Mass Index measure: Sports experience sex: ALL minimumAge: 8 Years maximumAge: 16 Years stdAges: CHILD facility: Department of Immunobiology and Environment Microbiology, Medical University of Gdańsk city: Gdańsk zip: 80-211 country: Poland lat: 54.35205 lon: 18.64637 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-01-15 uploadDate: 2024-04-22T03:58 filename: ICF_000.pdf size: 183809 hasResults: False

 nctId: NCT06325215 id: SCaglar briefTitle: The Effect of Hydrocolloid to Prevent Nasal Injuries in Preterm Infants overallStatus: COMPLETED date: 2022-05-05 date: 2022-10-29 date: 2022-11-05 date: 2024-03-22 date: 2024-03-22 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: The aim of this study is to evaluate the effect of using hydrocolloid tapes in preventing pressure injuries on the nose and columella regions caused by non-invasive mechanical ventilation (NIMV) in preterm infants. conditions: Pressure Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Experimantal primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: After providing information about the study to the parents of preterm newborns who met the inclusion criteria, informed consent forms were obtained without disclosing which group their babies would be assigned to. The research outcome measurements were recorded by two nurses working at NICU. Prior to the study, necessary training and information about the form and process were provided to the nurses. The data analysis was conducted by an independent statistician. whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 56 type: ACTUAL name: Hidrocolloid Bant measure: Neonatal Skin Condition Score measure: Pressure İnjury Staging Scale measure: Neonatal Skin Risk Assessment Scale sex: ALL minimumAge: 24 Weeks maximumAge: 37 Weeks stdAges: CHILD facility: Abide-i Hurriyet Cad. Istanbul University-Cerrahpaşa, Florence Nightingale Faculty of Nursing city: Istanbul zip: 34381 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06325202 id: STUDY00020946 id: 1U01DK135126 type: NIH link: https://reporter.nih.gov/quickSearch/1U01DK135126 briefTitle: Closed Loop and Education for Hypoglycemia Awareness Restoration acronym: CLEAR overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-06-30 date: 2027-12-31 date: 2024-03-22 date: 2024-03-26 name: Milton S. Hershey Medical Center class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) name: University of Minnesota name: University of Kentucky name: University of Pennsylvania name: University of California, San Diego name: AdventHealth name: University of Leicester name: University of Sheffield name: University of Melbourne name: Jaeb Center for Health Research briefSummary: The purpose of the CLEAR study is to determine the effect on counterregulatory responses (CRR) of intervening (by attempting to strictly avoid hypoglycemia) to improve awareness of hypoglycemic symptoms among adults with type 1 diabetes (T1D) who have impaired awareness of hypoglycemia (IAH). IAH affects 20-25% of adults with T1D, and rises with increasing duration of T1D. conditions: Diabetes Mellitus, Type 1 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Sequential Multiple Assignment Randomized Trial (SMART) design primaryPurpose: TREATMENT masking: NONE count: 324 type: ESTIMATED name: Omnipod 5 or Medtronic 780G name: My HypoCOMPaSS Education name: HARPdoc Education measure: epinephrine (pg/ml) measure: Towler questionnaire measure: geometric mean of plasma glucagon measure: geometric mean of plasma pancreatic polypeptide measure: geometric mean of plasma free fatty acids measure: glucose infusion rate measure: HbA1c measure: % of time with sensor hypoglycemia <70 mg/dL measure: % of time with sensor hypoglycemia <54 mg/dL measure: number of hypoglycemia events measure: % time with sensor glucose in range measure: sensor glucose coefficient of variation measure: sensor use as the average numbers of days per week measure: glycemia risk index measure: Trail Making Test - Part B measure: Four Choice Reaction Time measure: sleep duration measure: sleep quality measure: 24-hour step count measure: exercise bouts measure: resting heart rate measure: heart rate during exercise measure: heart rate variability measure: Hypo-METRICS questionnaire measure: Hypoglycemic Confidence Scale measure: Hypoglycemia Fear Survey-II measure: Attitudes to Awareness of Hypoglycaemia measure: Type 1 Diabetes Distress Scale measure: Diabetes Self-Management Questionnaire measure: Diabetes Management Experiences Questionnaire measure: PROMIS Sleep Disturbance - Short Form 8a measure: Hospital Anxiety and Depression Scale measure: 12-Item Hypoglycemia Impact Profile measure: EQ-5D-5L measure: device-related adverse events measure: severe hypoglycemic events, self-reported on a CLEAR data collection form measure: diabetic ketoacidosis (DKA) events measure: number of participants with hospitalizations measure: number of participants with emergency room (ER) visits measure: major adverse cardiovascular events (MACE) measure: all-cause mortality sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, San Diego city: La Jolla state: California zip: 92037 country: United States name: Jeremy H Pettus, MD role: CONTACT phone: 858-246-2160 email: jpettus@ucsd.edu name: Jeremy H Pettus, MD role: PRINCIPAL_INVESTIGATOR lat: 32.84727 lon: -117.2742 facility: AdventHealth city: Orlando state: Florida zip: 32804 country: United States name: Keri Whitaker role: CONTACT phone: 407-303-2519 email: keri.whitaker@adventhealth.com name: Richard E Pratley, MD role: PRINCIPAL_INVESTIGATOR name: Anna Casu, MD role: PRINCIPAL_INVESTIGATOR lat: 28.53834 lon: -81.37924 facility: University of Kentucky city: Lexington state: Kentucky zip: 40508 country: United States name: Simon Fisher, MD, PhD role: CONTACT phone: 859-562-0473 email: simon.fisher@uky.edu name: Simon Fisher, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.98869 lon: -84.47772 facility: University of Minnesota city: Minneapolis state: Minnesota zip: 55455 country: United States lat: 44.97997 lon: -93.26384 facility: University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Cornelia (Ginger) Dalton-Bakes role: CONTACT phone: 215-746-2085 email: corneliv@pennmedicine.upenn.edu name: Michael R Rickels, MD, MS role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: University of Melbourne city: Fitzroy state: Victoria zip: 3065 country: Australia name: Katrin Brown role: CONTACT phone: 61 3 9231 2574 email: katie.brown@unimelb.edu.au name: Catriona Sims role: CONTACT phone: 61 3 9231 2574 email: catriona.sims@unimelb.edu.au name: David O'Neal, MD role: PRINCIPAL_INVESTIGATOR lat: -37.79839 lon: 144.97833 facility: University of Leicester city: Leicester zip: LE5 4PW country: United Kingdom name: Andrew Kingsnorth role: CONTACT phone: 44 116-258-4874 email: a.kingsnorth@leicester.ac.uk name: Pratik Choudhary, MBBS role: PRINCIPAL_INVESTIGATOR lat: 52.6386 lon: -1.13169 facility: University of Sheffield city: Sheffield zip: S10 2RX country: United Kingdom name: Simon Heller, MD role: CONTACT phone: 44 114-215-9009 email: s.heller@sheffield.ac.uk name: Simon Heller, MD role: PRINCIPAL_INVESTIGATOR lat: 53.38297 lon: -1.4659 hasResults: False

 nctId: NCT06325189 id: Rec-42336 briefTitle: Effects of Aerobic Interval Training on Fatigue Level and Functional Performance in Post Angioplasty Patients overallStatus: COMPLETED date: 2023-07-20 date: 2023-12-01 date: 2023-12-10 date: 2024-03-22 date: 2024-03-22 name: Riphah International University class: OTHER briefSummary: The goal of this randomized controlled trial is to determine the effects of aerobic interval training on levels of tiredness and functional performance in post-angioplasty patients. The main question it aims to answer is:

Does aerobic interval training reduce fatigue and improve functional performance compared to medication alone in post-angioplasty patients?

Participants will:

Be randomly assigned to either the control group (medication) or the experimental group (medication + aerobic interval training) Perform aerobic interval training for 30 minutes, three times a week, for six weeks (experimental group only) Complete pre and post-intervention assessments using the fatigue severity scale, the 6-minute walk test, and the one minute sit to stand test Researchers will compare the two groups to see if aerobic interval training leads to significant improvements in fatigue levels and functional performance. conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In this parallel-group randomized controlled trial (RCT), post-angioplasty patients will be assigned to either the control group (receiving standard medication) or the experimental group (receiving medication along with aerobic interval training). The study aims to evaluate the impact of aerobic interval training on fatigue levels and functional performance in these patients. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The study was single-blinded, as assessors of the study were kept blind to the intervention group to which the participant was allocated. whoMasked: OUTCOMES_ASSESSOR count: 47 type: ACTUAL name: Aerobic Interval Training measure: Fatigue Severity Scale measure: Six Minute Walk Test measure: 1 minute sit to stand: sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gulab Devi Chest Hospital city: Lahore state: Punjab zip: 54000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06325176 id: REC/RCR & AHS/23/0569 briefTitle: Comparative Effects of Cryotherapy and Infrared Light on Pain, Redness, and Healing of Episiotomy Wound overallStatus: RECRUITING date: 2024-03-20 date: 2024-10-01 date: 2024-10-15 date: 2024-03-22 date: 2024-04-05 name: Riphah International University class: OTHER briefSummary: The study will be a randomized clinical trial and will be conducted in Bahawalpur Victoria Hospital, Bahawalpur. The subjects (n=24) will be divided into two groups. Group A will include 12 postnatal women and for treatment, cryotherapy will be applied for 20 minutes. Group B will include 12 women and receive infrared light, an infrared lamp will be put at a distance of 45 cm from the perineum, and the heat produced with 230 volts for twenty minutes. The participant will be checked after the first five minutes to make sure that she is not being burned. This procedure will be done twice a day for 7 consecutive days. conditions: Episiotomy Wound studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Cryotherapy name: Infrared light therapy measure: Numeric Pain Rating Scale measure: The standardized REEDA scale: sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Bahawalpur Victoria Hospital(BVH) status: RECRUITING city: Bahāwalpur state: Punjab zip: 63100 country: Pakistan name: Ghulam Fatima, PhD* role: CONTACT phone: 03034073057 email: ghulam.fatima@riphah.edu.pk lat: 29.4 lon: 71.68333 hasResults: False

 nctId: NCT06325163 id: MIU-IRB-2223-219 briefTitle: Accuracy of Artificial Intelligence Technology in Detecting Number of Root Canals in Human Mandibular First Molars Obturated and Indicated for Retreatment: Diagnostic Accuracy Experimental Study overallStatus: COMPLETED date: 2023-01-25 date: 2023-10-02 date: 2023-10-10 date: 2024-03-22 date: 2024-03-22 name: Misr International University class: OTHER briefSummary: evaluate the accuracy of new AI technology for detecting root canals in mandibular first molars retreatment cases in comparison to dentist clinical access cavity and CBCT imaging. conditions: Missed Canals studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: DIAGNOSTIC masking: NONE count: 35 type: ACTUAL name: CBCT name: clinical examination under dental operating microscope name: canal detection AI software (diagnocat) measure: Number of canals measure: linear morphological variations in failed cases sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Misr International University city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06325150 id: STUDY00008572 briefTitle: The Impact of Light Exposure on Cognitive Function in Classrooms overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-02-01 date: 2028-02-01 date: 2024-03-22 date: 2024-03-22 name: Michigan State University class: OTHER briefSummary: Humans are constantly exposed to a variety of light types, created naturally or through artificial means. Light exposure captured by the eyes impacts many physiological functions in humans, including but not limited to cognitive output, fatigue levels, and mood regulation. The level of impact on cognitive learning from different types of light on undergraduate adult students remains unclear. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This study will test the effect of light emitting glasses, vs placebo, vs no-glasses to attention in college students. This is a crossover study, where participants will be randomly assigned to one of three groups, and tested in random order. The students will be tested on 2 or 3 different conditions (no glasses, placebo or light emitting glasses). The assignment to each of the groups, and the order of the intervention (+/- glasses) will be randomized.

Note-light emitting glasses are not FDA regulated. Because light emitting glasses can change physiology, this is considered a phase 1 clinical trial. primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: Light emitting glasses measure: Assessment of attention measure: Determine how time of day impacts attention sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Michigan State University city: East Lansing state: Michigan zip: 48824 country: United States name: Hanne M Hoffmann, PhD role: CONTACT phone: 517-353-1415 email: hanne@msu.edu lat: 42.73698 lon: -84.48387 hasResults: False

 nctId: NCT06325137 id: RC 24/2022 briefTitle: Transcriptome Analysis in Idiopathic Nephrotic Syndrome: Steroid Responsiveness overallStatus: RECRUITING date: 2023-03-16 date: 2025-03 date: 2025-03 date: 2024-03-22 date: 2024-03-22 name: IRCCS Burlo Garofolo class: OTHER briefSummary: Idiopathic nephrotic syndrome (INS) affects the glomerular barrier by damaging the podocytes with foot process effacement, leading to a pathological increase of permeability and protein loss. INS classification is based on the clinical response to glucocorticoid (GC) therapy. When GCs treatment fails to induce remission in a four-six weeks course, patients are defined as affected with steroid-resistant nephrotic syndrome (SRNS).

The whole transcriptome sequencing could consent the INS classification at onset, prior to glucocorticoids (GCs) treatment, allowing to reduction of unuseful GCs treatment. RNA sequencing technologies allow an extensive characterization of the transcriptomic profile and permit global changes in gene expression levels between different conditions such as active and remission of the disease.

Of great interest is the research of a molecular biomarker to predict steroid resistance, a predictor that is not yet available. Among the candidate biomarkers, pharmacogenomic determinants are promising, even if available studies are still limited. Among these, some epigenetic factors have been previously suggested. Data obtained in animal models suggests that nucleotide-binding oligomerization domain-like receptors (NOD-like receptor) pyrin domain containing 3 (NLRP3) inflammasome can be deregulated in a wide variety of glomerular diseases, including those causing INS. Another potential marker involved in steroid response is the long noncoding RNA GAS5. Data reported in the literature indicate that abnormal levels of GAS5 in peripheral blood mononuclear cells (PBMCs) may alter steroid effectiveness in autoimmune diseases, such as inflammatory bowel disease.

Preliminary findings show that the study of NLRP3 promoter methylation could be reduced in the blood of SRNS compared with steroid-sensitive nephrotic syndrome (SSNS) patients. Moreover, unpublished encouraging results on the association between Growth Arrest Specific 5 (GAS5) expression and steroid response in INS in PBMCs were obtained in a preliminary study conducted on 8 patients with the first episode of INS. PBMCs were obtained and GAS5 gene expression was evaluated using TaqMan technology. Patients affected with SRNS presented significantly higher levels of GAS5 in comparison with the SSNS group. In PBMCs from SRNS patients, the GAS5 expression could reduce the availability for binding to GCs target genes of the activated GCs receptor and suppresses GC transcriptional activity. conditions: Nephrotic Syndrome studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED name: Transcriptome analyses measure: Between groups differences in molecular signature by whole transcriptome analysis sex: ALL minimumAge: 1 Year maximumAge: 12 Years stdAges: CHILD facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" status: RECRUITING city: Trieste zip: 34137 country: Italy name: Marco Pennesi, MD role: CONTACT phone: +39.040-3785263 email: marco.pennesi@burlo.trieste.it name: Barbara Bonifacio role: CONTACT phone: +39.040.3785.422 email: barbara.bonifacio@burlo.trieste.it lat: 45.64953 lon: 13.77679 hasResults: False

 nctId: NCT06325124 id: REC/01805 MARIA NAWAZ briefTitle: Muscle Energy Technique of Lower Limb Muscles in Forward Head Posture overallStatus: RECRUITING date: 2024-03-26 date: 2025-03-20 date: 2025-04-20 date: 2024-03-22 date: 2024-04-03 name: Riphah International University class: OTHER briefSummary: The aim of this randomized controlled trial is to find the effect of muscle energy technique of muscles involved in lower limb superficial backline (hamstring and Gastro-soleus) on improving craniovertebral angle and cervical proprioception and minimizing pain among patients with forward head posture conditions: Forward Head Posture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 36 type: ESTIMATED name: Muscle energy technique name: Conventional PT measure: Neck disability index (NDI) measure: Numeric Pain Rating Scale NPRS measure: Bubble inclinometer measure: FHP Mobile Application (To measure Craniovertebral angle) measure: Cervical Joint Position Error sex: ALL minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: We Care Physical Therapy Clinic street 13 phase 4A, Ghouri town Islamabad status: RECRUITING city: Islamabad state: Punjab country: Pakistan name: KINZA ANWAR, MS-OMPT role: CONTACT phone: +92-3239735427 email: kinza.anwar@riphah.edu.pk name: MARIA NAWAZ, MS-OMPT* role: CONTACT phone: +92-3435625466 name: MARIA NAWAZ role: SUB_INVESTIGATOR lat: 33.72148 lon: 73.04329 hasResults: False

 nctId: NCT06325111 id: RC 06/2023 briefTitle: Determinants of Glycaemic Control in Children With Type 1 Diabetes overallStatus: RECRUITING date: 2023-05-29 date: 2026-04-30 date: 2026-04-30 date: 2024-03-22 date: 2024-03-22 name: IRCCS Burlo Garofolo class: OTHER briefSummary: Type 1 diabetes (T1D) is a common chronic disease of childhood associated with a significantly increased risk of micro- and macro-vascular complications, including neuropathy, nephropathy and cardiovascular diseases. The risk of development T1D comorbidities is associated with glycaemic control, a complex mechanism involving biological, physiological environmental factors.

While more than 60 genetic variants were already associated with Glycated hemoglobin (HbA1c) in healthy subjects, very few genes have been identified in T1D individuals. Also, hyperglycaemia could be the cause of epigenetic changes at specific target genes, such as DNA methylation, histone modifications and microRNAs, correlated to accelerated development of diabetes-related complications. Most recently, increasing evidence also suggested that human microbiome may play a crucial role in the onset and progression of T1D and dysbiosis of the gut and oral microbiota was reported as a typical feature of hyperglycaemia.

However, potential differences among poorly and good managed T1D subjects have not been still studied. Also, the exact mechanism by long-term hyperglycaemia's acts in T1D remains poorly understood. Therefore, this project will explore an emerging area of research by the study of possible genetic, epigenetic and environmental biomarkers among T1D subjects with different glycaemic control. conditions: Diabetes Mellitus, Type 1 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 800 type: ESTIMATED name: Determinants of T1D glycaemic control measure: Identification of genes involved in T1D glycaemic control measure: Identification of DNA methylation patterns involved in T1D glycaemic control measure: Identification of microRNAs involved in T1D glycaemic control measure: Identification of oral microbiome characteristics associated to T1D glycaemic control sex: ALL minimumAge: 6 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" status: RECRUITING city: Trieste zip: 34137 country: Italy name: Eulalia Catamo, BSc role: CONTACT phone: +39 040.3785470 email: eulalia.catamo@burlo.trieste.it lat: 45.64953 lon: 13.77679 hasResults: False

 nctId: NCT06325098 id: PER-NEPH briefTitle: Implementation of a Diagnostic Workflow for Personalized Diagnosis of Nephrotic Syndrome overallStatus: RECRUITING date: 2022-01-26 date: 2026-01-31 date: 2026-06-30 date: 2024-03-22 date: 2024-03-22 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Nephrotic syndrome (NS) is a clinical picture common to several diseases resulting from damage to podocytes and glomerular filtration barrier. Currently, there is limited consensus regarding the diagnostic pathway and management of the specific etiology. Some patients show complete response to first-line steroid therapy (steroid-sensitive nephrotic syndrome, SSNS), especially in children and young adults. The prognosis of this group is generally favorable. In contrast, patients unresponsive to steroids (steroid-resistant NS, SRNS) frequently undergo immunosuppressive therapies, which are burdened with numerous side effects. Resistance to treatment is associated with a high likelihood of progression to chronic renal disease (CKD) and kidney failure (ESKD). Recent evidence suggests that immunological mechanisms (including permeabilizing factors) are involved in the pathogenesis of post-transplant NS recurrence and SSNS.

Providing patients with NS with a correct diagnosis is the cornerstone of personalized medicine, reducing morbidity and side effects of therapies, ensuring their appropriate prescription, and slowing or preventing progression to ESKD. conditions: Nephrotic Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients with nephrotic syndrome (SSNS, SRNS) primaryPurpose: DIAGNOSTIC masking: NONE count: 150 type: ESTIMATED name: Anti-nephrin antibodies name: u-RPC cultures measure: Role of anti-nephrin antibodies in the pathogenesis of NS measure: Functional role of VUS in the pathogenesis of SRNS measure: Identification of potential predictive biomarkers of renal outcome. measure: Cost-effectiveness analysis sex: ALL minimumAge: 1 Month maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Firenze country: Italy name: Paola Romagnani role: CONTACT lat: 43.77925 lon: 11.24626 hasResults: False

 nctId: NCT06325085 id: Ayesha Saddiqa briefTitle: Compensatory and Restorative Rehabilitation Techniques in Stroke acronym: The overallStatus: RECRUITING date: 2024-04-16 date: 2025-03-20 date: 2025-04-20 date: 2024-03-22 date: 2024-04-22 name: Riphah International University class: OTHER briefSummary: The aim of this randomized controlled trial is to find the combined effects of restorative and compensatory cognitive rehabilitation techniques in mild cognitive impairment after stroke. conditions: Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 36 type: ESTIMATED name: compensatory and restorative rehabilitation techniques name: Traditional cognitive rehabilitation training measure: Montreal cognitive assessment test (Urdu version) measure: Cognitive assessment scale for stroke patients (CASP) measure: Stroke specific quality of life questionnaire (Urdu version) measure: Modified Rankin Scale (MRS) sex: ALL minimumAge: 50 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shafi Hospital Dina status: RECRUITING city: Dina state: Punjab country: Pakistan name: Dr. Aroosa Tariq, MS:NMPT role: CONTACT phone: 03161578156 email: aroosa.tariq@riphah.edu.pk name: Ayesha Saddiqa, MS:NMPT* role: CONTACT phone: 0315-5568417 email: aisha.sadeeqa23@gmail.com name: Dr. Aroosa Tariq, MS:NMPT role: PRINCIPAL_INVESTIGATOR name: Ayesha Saddiqa, MS:NMPT* role: SUB_INVESTIGATOR hasResults: False

 nctId: NCT06325072 id: NIKE briefTitle: Set-up of a Platform for Personalized Diagnosis of Rare Kidney Diseases (NIKE) overallStatus: ACTIVE_NOT_RECRUITING date: 2021-07-09 date: 2023-06-27 date: 2024-06-30 date: 2024-03-22 date: 2024-03-22 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Chronic kidney disease (CKD) is a major health problem, with steadily increasing incidence and prevalence and the threat of a true "epidemic". Converging evidence suggests a high prevalence of genetic etiology in rare kidney diseases and the list of new disease-causing genes is constantly updated. Recent advances in next-generation sequencing (NGS) technologies have prompted a significant improvement in the diagnosis of rare kidney diseases. Notwithstanding this, NGS generates high numbers of information that need to be properly analysed by the joint efforts of geneticists, nephrologists and bioinformatics in order to integrate clinical and genetic information in a personalized manner. In addition, in selected cases, the contribution of researchers proves essential for the development of experimental models of the disease to study and understand the pathogenic features and propose a personalized therapeutic approach. Such an innovative, integrated diagnostic paradigm is currently available in few centers all over the world and cannot be easily translated in daily clinical practice.

The aim of the study is to set-up an integrated diagnostic algorithm to extend the newest personalized diagnostic and treatment strategies for rare kidney diseases to all patients in the Tuscany region, under 40 years of age with kidney disease. This algorithm will be based on a constant cross-talk between participating centers and a dedicated multidisciplinary team. Diagnostic and therapeutic performances will be validated at European level. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients selected based on the inclusion criteria will be evaluated by a multidisciplinary team of experts. All the selected patients will undergo genetic testing by clinical exome sequencing and in silico filtering for a panel of genes described as causing or in association with CKD. Identified variants will be classified according to the American College of Medical Genetics and Genomics (ACMG) guidelines. Reverse phenotyping will be performed according to the results of genetic testing. The results of the diagnostic work-up will be evaluated by a multi-disciplinary team of experts in order to establish conclusive diagnosis. primaryPurpose: DIAGNOSTIC masking: NONE count: 160 type: ESTIMATED name: Conclusive genetic testing name: Genotype-phenotype correlation for personalized diagnosis name: Personalized study of variants of uncertain clinical significance (VUS) through functional studies on 3D organ-on-a-chip measure: Validation of genetic diagnosis measure: Identification of molecular pathways measure: Explore the applicability of gene editing in rare kidney diseases sex: ALL maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Azienda Ospedaliero Universitaria Careggi city: Firenze country: Italy lat: 43.77925 lon: 11.24626 facility: Meyer Children's Hospital IRCCS city: Firenze country: Italy lat: 43.77925 lon: 11.24626 facility: USL Toscana Centro city: Firenze country: Italy lat: 43.77925 lon: 11.24626 facility: Azienda Ospedaliero Universitaria Pisana city: Pisa country: Italy lat: 43.70853 lon: 10.4036 hasResults: False

 nctId: NCT06325059 id: BIO-KIDNEY briefTitle: The Role of Renal Progenitors and Polyploid Tubular Cell Response in Glomerular and Tubular Diseases overallStatus: RECRUITING date: 2023-03-22 date: 2047-03-22 date: 2047-11-30 date: 2024-03-22 date: 2024-03-22 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Renal progenitors are a subset of parietal epithelial cells (PECs) localized at the urinary pole of Bowman's capsule. Experimental models of podocyte damage showed that PECs can potentially regenerate lost podocytes by migrating from Bowman's capsule to the glomerular tuft, acquiring the morphological and functional features of mature podocytes. Podocyte loss and damage, as well as the inability of PECs to replace lost podocytes, lead to glomerular scarring and chronic kidney disease (CKD) progression.

In addition, the investigators of the present study and others have recently demonstrated the existence of a specific subpopulation of tubular cells in the human kidney with a high potential for regeneration and resistance to death, thus acting as tubular progenitors. These cells are involved in tubular response to damage during acute kidney injury (AKI) trough endoreplication (polyploidization).

Kidney biopsy is the cornerstone of diagnosis in many kidney diseases leading to CKD and AKI, allowing unambiguous diagnosis in some cases and presumptive diagnosis of ongoing disease in others. Very recently, super resolution imaging techniques proved to maintain current diagnostic standards while allowing to study morphological features of pathophysiological mechanisms of glomerular and tubular diseases.

The rationale of this project is to study the role of renal progenitors (PECs and tubular progenitors) in the pathogenesis of CKD and AKI trough super resolution imaging applied to human renal biopsies, to the aim of identifying relevant connections with clinical data and markers of damage and/or disease progression. conditions: Nephropathy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients affected by nephropathy primaryPurpose: BASIC_SCIENCE masking: NONE count: 200 type: ESTIMATED name: Study of renal progenitors measure: Evaluation of the role of renal progenitors in the progression of glomerular diseases measure: Evaluation of the role of tubular endoreplication in mechanisms of acute kidney injury (AKI) measure: Evaluation of the role of tubular endoreplication in mechanisms of acute kidney injury (AKI) trough DNA and RNA analysis sex: ALL minimumAge: 1 Month maximumAge: 17 Years stdAges: CHILD facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Firenze country: Italy name: Paola Romagnani role: CONTACT lat: 43.77925 lon: 11.24626 hasResults: False

 nctId: NCT06325046 id: 23-003388 id: NCI-2024-01669 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: GMROR2351 type: OTHER domain: Mayo Clinic Radiation Oncology id: 23-003388 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: Evaluating Changes in Quality of Life After Near Margin-less Adaptive Radiation Therapy Compared to Standard Stereotactic Ablative Body Radiotherapy in Localized Prostate Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-06 date: 2026-06 date: 2024-03-22 date: 2024-04-01 name: Mayo Clinic class: OTHER briefSummary: This clinical trial evaluates changes in quality of life after two treatments with near margin-less adaptive radiation therapy (ART) compared to five treatments with standard stereotactic ablative body radiotherapy (SABR) in patients with prostate cancer that has not spread to other parts of the body (localized). ART is a type of radiation therapy that uses information gathered during the treatment cycle to inform, guide, and alter future radiation treatments with respect to location and dose. It may be able to deliver radiation to the site of disease over a shorter time and with smaller margins (less treatment delivered to nearby healthy tissues). SABR is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Shorter duration near margin-less ART may be just as effective at treating patients with localized prostate cancer but have less quality of life side effects than standard SABR. conditions: Localized Prostate Adenocarcinoma conditions: Stage I Prostate Cancer AJCC v8 conditions: Stage II Prostate Cancer AJCC v8 conditions: Stage III Prostate Cancer AJCC v8 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 144 type: ESTIMATED name: Computed Tomography name: Cone-Beam Computed Tomography name: Image-Guided Adaptive Radiation Therapy name: Magnetic Resonance Imaging name: Stereotactic Ablative Radiotherapy name: Survey Administration measure: Treatment-related, patient-reported early quality of life (QOL) changes measure: Treatment-related, patient-reported late QOL changes measure: Incidence of grade ≥ 2 genitourinary an/or gastrointestinal adverse events measure: Change in International Index of Erectile Function (IIEF) measure: Change in International Prostate Symptom Score (IPSS) measure: Change in financial adverse events - COST-FACIT measure: Fiducial-free treatment measure: Bladder filling measure: Biochemical recurrence measure: Prostate specific antigen (PSA) kinetics measure: Local recurrence measure: Overall survival sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Mark R. Waddle, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06325033 id: 18546 briefTitle: Prospective Validation of the Eleveld Model of Propofol for Procedural Sedation in Adults. overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2025-01 date: 2024-03-22 date: 2024-03-22 name: University Medical Center Groningen class: OTHER briefSummary: The goal of this prospective observational study is to identify effect site concentrations (CET) of propofol using the Eleveld model for different levels of procedural sedation.

The main question it aims to answer is to identify CET propofol using the Eleveld model for different levels of procedural sedation as measured by the modified observer's assessment of alertness and sedation score (MOAAS) and EEG monitoring.

Participants vital signs will be monitored according to the departmental protocol. Sedation will be administered using Target-Controlled Infusion (TCI) of propofol (administered by effect-site TCI using the Eleveld model) and remifentanil (administered by effect site TCI using the Eleveld model). Target controlled infusion of propofol and remifentanil is according to the departmental protocol. The MOAAS score will be noted every 5 minutes or when the target effect site concentration of propofol is altered. Depth of sedation will also be monitored using a non-invasive BIS® monitor. conditions: Deep Sedation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 75 type: ESTIMATED measure: To identify effect-site target concentrations of propofol for the Eleveld model that are associated with moderate to deep sedation levels, MOAAS 3-1 and the associated BIS levels in adult patients. measure: Induction time measure: Recovery time measure: Adverse events sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-11-23 uploadDate: 2024-02-29T03:59 filename: Prot_000.pdf size: 454063 hasResults: False

 nctId: NCT06325020 id: 337367 briefTitle: Objective Risk Assessment in Patients With Possible Anginal Chest Pain Using Leading Technology acronym: ORACLE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-11-01 date: 2025-02-28 date: 2024-03-22 date: 2024-03-22 name: University of Edinburgh class: OTHER briefSummary: The ORACLE study is an observational cohort study designed to explore the feasibility of providing an assessment of chest pain for patients with suspected angina within one working day of referral to specialist services.

The primary objective is to determine the feasibility of delivering an objective assessment of risk for participants who have been referred by their primary care provider to the rapid access chest pain clinic with possible angina in a community setting using point of care and patient facing technologies within one working day of referral.

Participants will complete a digital health questionnaire, at home, that asks about their risk factors for coronary artery disease, past medical history and their symptoms.

Patients will then have a standard 12 lead ECG and perform their own personal ECG. They will then have high sensitivity cardiac troponin measured by point of care high sensitivity cardiac troponin assays as well as a core lab assay.

The results of all of the above will allow patients to be started as low, intermediate or high risk for future cardiovascular events. conditions: Angina, Stable conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: The assessment of patients with possible angina using the ORACLE pathway measure: Proportion of participants in whom a chest pain risk assessment is complete within one working day of referral. measure: Proportion of patients who can have their risk assessment completed in one, two or three or more working days from referral to service until completion of risk assessment. measure: Proportion of valid and interpretable point-of-care troponin tests measure: Proportion of personal electrocardiograms that are interpretable measure: Proportion of participants stratified as low, intermediate, or high risk using objective risk stratification. measure: Proportion of participants with and without a clinical diagnosis of angina stratified as low, intermediate, or high risk and according to triage status. measure: Proportion of participants with unscheduled Emergency Department attendance(s) at 3 months stratified as low, intermediate, or high risk and according to triage status. measure: Proportion of participants with cardiac death or non-fatal myocardial infarction at 3 months stratified as low, intermediate, or high risk and according to triage. measure: Proportion of participants reclassified as low, intermediate, or high risk using standard laboratory assays compared to point-of-care high-sensitivity cardiac troponin assay. measure: Proportion of participants reclassified as low, intermediate, or high risk using standard 12-lead compared to personal 12-lead electrocardiography sex: ALL minimumAge: 30 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06325007 id: 293-2024-HFH briefTitle: Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous overallStatus: RECRUITING date: 2024-04-11 date: 2024-12-15 date: 2024-12-31 date: 2024-03-22 date: 2024-04-15 name: Holy Family Hospital, Nazareth, Israel class: OTHER briefSummary: The goal of this randomized controlled trial is to examine the efficacy of combining castor oil ingestion with extra-amniotic single balloon catheter for cervical ripening on time from induction to delivery in nulliparous women.

The main question it aims to answer are:

Does the addition of the use of castor oil to extra-amniotic single balloon reduce the time until birth? Does the addition of the castor oil affect other perinatal outcomes during childbirth? Are the side effects of the castor tolerated by the mothers? Participants will be randomly divided into 2 groups: the study group will drink a mixture of 60 ml of castor oil mixed with 140 ml of orange juice. Thirty minutes later, an extra-amniotic single balloon catheter will be inserted above the internal cervical os and filled with 60 mL of normal saline. In the control group, a foley catheter will be inserted into cervical canal without ingestion of castor oil. conditions: Induction of Labor Affected Fetus / Newborn studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 142 type: ESTIMATED name: Induction of labor measure: time to delivery measure: balloon expulsion time measure: Bishop score after catheter expulsion measure: Fetal presentation at the delivery measure: Duration of the active phase of labor measure: Duration of second stage measure: Mode of delivery measure: Indications for cesarean or operative vaginal deliveries measure: Intrapartum fever measure: Number of patients that will require use of intrapartum use of antibiotic treatment. measure: Number of Participants with that will develop clinical signs of chorioamnionitis. measure: Number of Participants with that will develop 3rd and 4th degrees perineal lacerations. measure: Number of Participants with develop postpartrum hemorrhage. measure: Number of Participants with need blood transfusion. measure: Side effects related to castor oil use measure: Oxytocin maximal dosage measure: Number of participants with Umbilical Cord prolapse. measure: Apgar score (0 to 10). measure: pH taken from umbilical artery measure: Neonatal birthweight measure: Number of neonates with Neonatal fever ≥ 38 °C measure: The number of neonates that will develop neonatal sepsis. measure: The number of neonates that will require antibiotic treatment. measure: Neonatal complications measure: The number of neonates that will Admit to neonatal intensive care unit (NICU) measure: Length of stay in NICU. measure: neonatal death measure: Maternal hemoglobin level after delivery. measure: Number of participants that will require postpartum hysterectomy. measure: Number of participants that will require postpartum laparotomy. measure: postpartum maternal complications measure: The length of stay from birth to discharge home. measure: Maternal satisfaction from delivery process. sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Holy Family hospital, Nazareth status: NOT_YET_RECRUITING city: Nazareth country: Israel name: Wiaamk Khatib, MD role: CONTACT phone: 0549192433 email: wiaam.khatib.95@gmail.com name: Wiaam Khatib, MD role: PRINCIPAL_INVESTIGATOR lat: 32.69925 lon: 35.30483 facility: Holy Family Hospital status: RECRUITING city: Nazareth country: Israel name: Raed Salim, MD role: CONTACT email: r.salim@hfhosp.org lat: 32.69925 lon: 35.30483 hasResults: False

 nctId: NCT06324994 id: YY-20394-BV-MCL briefTitle: Linperlisib Plus Obinutuzumab and Venetoclax for Relapsed and Refractory Blastoid Variant of Mantle Cell Lymphoma. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2026-12-01 date: 2024-03-22 date: 2024-03-22 name: Dalian Medical University class: OTHER briefSummary: This is a single arm, open label, national multicenter clinical study included patients with relapsed and refractory blastoid variant of mantle cell lymphoma (R/R BV-MCL), aiming to evaluate the efficacy of a chemotherapy free triple therapy of PI3K inhibitor (Linperlisib) combined with anti-CD20 monoclonal antibody (Obinutuzumab) and BCL-2 inhibitor (Venetoclax) in R/R BV-MCL patients. conditions: Mantle Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Linperlisib in combination with Obinutuzumab and Venetoclax measure: Objective Response Rate (ORR) according to the RECIST 1.1 measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Duration of Overall Response (DOR) measure: Adverse event (AE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Hospital Dalian Medical University city: Dalian state: Liaoning zip: 116000 country: China name: Xiuhua Sun, Doctor role: CONTACT phone: +86 17709873631 email: 3038668@vip.sina.com lat: 38.91222 lon: 121.60222 hasResults: False

 nctId: NCT06324981 id: 22-2097 id: 1UG3HL168504 type: NIH link: https://reporter.nih.gov/quickSearch/1UG3HL168504 briefTitle: Using AI Text Messaging to Improve AHA's Life's Essential 8 Health Behaviors overallStatus: RECRUITING date: 2024-02-26 date: 2028-02 date: 2028-06 date: 2024-03-22 date: 2024-03-22 name: University of Colorado, Denver class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The goal of our pragmatic clinical trial is to compare how well three different strategies might do to reduce risk factors for cardiovascular disease in patients experiencing health disparities. The three different strategies are: 1) text messages, 2) interactive chatbot messages, and 3) chatbot messages with proactive pharmacist support. To measure cardiovascular risk factors, the investigators are using the American Heart Association's Life's Essential 8 (LE8) factors-blood glucose, cholesterol, blood pressure, physical activity, body mass index, diet, and smoking.

This study focuses on improving cardiovascular risk factors for individuals facing health disparities, such as ethnic minorities, limited English proficiency, and low-income groups. These groups are more likely to be seriously affected by cardiovascular diseases. Self-management, or an individual's roles in managing their own chronic disease, includes lifestyle changes, medication adherence. Improving patients' self-management has been shown to improve health behaviors, better disease control and improved patient outcomes.

The main question this study aims to answer is if one of the strategies (texting, chatbot, or chatbot with pharmacist support) may improve patient self-management and patient outcomes.

The investigators will enroll up to 2,100 patients from three health systems that serve large populations experiencing health disparities: Denver Health, Salud Family Health Centers, and STRIDE Community Health Center.

The results might help researchers and health care systems find the best ways to involve patients with health disparities to managing their chronic cardiovascular disease. conditions: Cardiovascular Diseases conditions: Lifestyle Factors studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 2100 type: ESTIMATED name: Generic text messages name: Interactive AI chatbot text messaging name: Proactive pharmacist support measure: Change in Life's Essential 8 risk score measure: Blood pressure (Individual Life's Essential 8 components) measure: Total cholesterol (Individual Life's Essential 8 components) measure: Blood sugar (Individual Life's Essential 8 components) measure: Body Mass Index (Individual Life's Essential 8 components) measure: Physical activity (Individual Life's Essential 8 components) measure: Sleep (Individual Life's Essential 8 components) measure: Smoking habits (Individual Life's Essential 8 components) measure: Health diet pattern (Individual Life's Essential 8 components) measure: Self-Efficacy for Managing Chronic Diseases measure: Number of medication refill gaps (Medication adherence) measure: Length of refill gaps (Medication adherence) measure: Clinic events measure: Risk Score for Recurrent Coronary Heart Disease, Framingham Risk Score measure: Risk Score for Coronary Heart Disease (2-year risk) - First Event, Framingham Risk Score measure: Rate of routine clinical visits and/or other procedures associated with the clinical condition measure: Cost sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Denver Health status: RECRUITING city: Denver state: Colorado zip: 80204 country: United States name: Pamela Peterson, MD MPH role: CONTACT email: pamela.peterson@dhha.org lat: 39.73915 lon: -104.9847 facility: Salud Family Health Centers status: NOT_YET_RECRUITING city: Fort Lupton state: Colorado zip: 80621 country: United States name: Emily Kosirog, PharmD role: CONTACT email: ekosirog@saludclinic.org lat: 40.08471 lon: -104.81303 facility: STRIDE Community Health Centers status: NOT_YET_RECRUITING city: Wheat Ridge state: Colorado zip: 80033 country: United States name: Danielle Montoya, PharmD role: CONTACT email: danielle.montoya@stridechc.org lat: 39.7661 lon: -105.07721 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-10-11 uploadDate: 2023-12-04T16:49 filename: Prot_000.pdf size: 325640 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-02-26 uploadDate: 2024-03-04T15:41 filename: SAP_001.pdf size: 235057 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-07 uploadDate: 2024-03-04T16:34 filename: ICF_002.pdf size: 788437 hasResults: False

 nctId: NCT06324968 id: 22-AOIP-01 briefTitle: Ro60 Expression in Macrophages in Sjogren's Disease acronym: RoMioSS overallStatus: RECRUITING date: 2024-02-09 date: 2025-02-09 date: 2026-02-09 date: 2024-03-22 date: 2024-03-22 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Context: The Ro60 protein associates with YRNAs (or RNYs) to form the RoRNP complex, which regulates RNA surveillance and maturation. It is hypothesized that its impairment by nuclear penetration of the anti-Ro60 autoantibodies, would deregulate the anti-inflammatory response in monocytes/macrophages (Mo/Mp) in patients with Sjögren's disease (SD). conditions: Sjogren's Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 20 type: ESTIMATED name: Positive serology for anti-SSA measure: SSA/Ro60 interactions measure: The molecular and functional impact : inflammatory cytokine and chemokine profiles measure: The molecular and functional impact : cell apoptosis/survival and cellular polarization measure: The molecular and functional impact : clinical and biochemical phenotypes of CD14+ monocytes/macrophages sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Nice status: RECRUITING city: Nice state: Alpes-Mritimes zip: 06000 country: France name: Nihal MARTIS, MD, MSc role: CONTACT phone: 4 92035444 phoneExt: +33 email: martis.n@chu-nice.fr lat: 43.70313 lon: 7.26608 hasResults: False

 nctId: NCT06324955 id: IRB-P00042507 briefTitle: Language During Inhalational Induction overallStatus: NOT_YET_RECRUITING date: 2024-03-11 date: 2024-07-01 date: 2025-03-11 date: 2024-03-22 date: 2024-03-22 name: Boston Children's Hospital class: OTHER briefSummary: The aim of this study is to compare the impact of common (standard of care) language vs positive language used by clinicians during inhalational induction of anesthesia on anxiety and negative behaviors in children. This is a prospective randomized parallel group trial. Patients will be randomized 1:1 to the common/standard language group or the positive language group. conditions: Emergence Delirium conditions: Anesthesia; Adverse Effect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 128 type: ESTIMATED name: Standard/common language during induction name: Positive language during induction measure: Induction compliance measure: Length of induction measure: Verbal refusal of mask sex: ALL minimumAge: 5 Years maximumAge: 10 Years stdAges: CHILD facility: Boston Children's Hospital city: Boston state: Massachusetts zip: 02115 country: United States name: John Fiadjoe, MD role: CONTACT email: john.fiadjoe@childrens.harvard.edu name: Rachel Bernier, MPH role: CONTACT phone: 857-218-5348 email: rachel.bernier@childrens.harvard.edu lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06324942 id: REB24-0349 briefTitle: Analgesic Efficacy of Surgeon-administered Transversus Abdominis Plane Blocks for Caesarean Section. overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-12 date: 2024-03-22 date: 2024-03-22 name: University of Calgary class: OTHER briefSummary: The purpose of this research study is to evaluate whether or not adding a Transversus Abdominis Plane Block (TAP block) improves pain control for patients having a cesarean section. A TAP block is a type of nerve block where at the end of the surgery an injection of a long acting local anesthetic is made into the abdominal wall. In studies in patient's having other abdominal surgeries this has reduced the amount of narcotics patients need for pain control. This may also led to patients being more active after surgery and maybe spending less time in hospital. conditions: Cesarean Section Complications conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Surgeon-administered Transversus Abdominis Plane Block 0.25% bupivicaine 0.25 mL/kg measure: Post operative Pain measure: Time to first request for rescue analgesia in hours measure: Post operative Opioid use measure: Time from surgery to discharge from hospital sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Calgary city: Calgary state: Alberta zip: T2N 2T9 country: Canada lat: 51.05011 lon: -114.08529 hasResults: False

 nctId: NCT06324929 id: HSR220448 id: R61AA030581-01 type: NIH link: https://reporter.nih.gov/quickSearch/R61AA030581-01 briefTitle: Optimizing a Digital AEP Risk Intervention With Native Women and Communities Aim 1 acronym: CARRII Native overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-09 date: 2025-03-31 date: 2024-03-22 date: 2024-03-27 name: University of Virginia class: OTHER name: University of Minnesota name: Missouri Breaks Industries Research, Inc. name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: The purpose of this aim of the ovedrall study is to gather information to inform the development of a digital app that can be used on any platform (smartphone, tablet, computer) for Native American women to help them avoid a pregnancy affected by alcohol. conditions: Alcohol Exposed Pregnancy conditions: Unplanned Pregnancies conditions: Alcohol Use, Unspecified conditions: Contraception Use conditions: Sexual Behavior studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Mixed methods research during Aim 1 will include 4 different components. They are:

1. Convene working group of Native American stakeholders.
2. Collect data using a 35-minute survey of demographics, AEP risk, device use, recommendations for recruitment methods, and interest in subsequent trial with 300 Native women respondents, targeting approximately 100-150 per region (rural Great Northern Plains), urban Denver and mountain West, and rural Southwest .
3. Conduct Iterative prototyping of existing and proposed CARRII components with 60 Native women across 10 focus group discussions. Content will be informed by Components 1 and 2, and will be added via modification request
4. Conduct User Testing of existing CARRII and candidate components with Think-Aloud methods among 20 Native women. primaryPurpose: OTHER masking: NONE count: 300 type: ESTIMATED name: Survey measure: Determine the characteristics of and rate of Native women eligible for, and interested in the CARRII intervention. sex: FEMALE minimumAge: 18 Years maximumAge: 44 Years stdAges: ADULT facility: University of Virginia Fontaine Research Park city: Charlottesville state: Virginia zip: 22908 country: United States name: Karen Ingersoll, PhD role: CONTACT phone: 804-651-6929 email: kes7a@uvahealth.org lat: 38.02931 lon: -78.47668 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-24 uploadDate: 2024-03-22T09:41 filename: Prot_SAP_000.pdf size: 558452 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-02 uploadDate: 2024-03-22T09:41 filename: ICF_001.pdf size: 242257 hasResults: False

 nctId: NCT06324916 id: vascularized fibular graft briefTitle: Donor Site Morbidity After Free Vascularized Fibular Graft overallStatus: RECRUITING date: 2024-01-10 date: 2026-01-10 date: 2026-12-30 date: 2024-03-22 date: 2024-03-22 name: Assiut University class: OTHER briefSummary: This study was carried out at Assiut University to Asses the long-term donor site morbidity following free vascularized fibular transfer because there is a limited information regarding the long-term donor morbidity of this type of flap. conditions: Osteosarcoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 20 type: ESTIMATED name: Xray measure: Donor site morbidity in contrast with surgery benifits this will be measured by point evaluation system sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Assiut university status: RECRUITING city: Assiut country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06324903 id: echo cath CHD briefTitle: Role of Echocardiography in Optimization of Cardiac Catheterization in Children With Congenital Heart Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04 date: 2025-10-30 date: 2024-03-22 date: 2024-03-22 name: Assiut University class: OTHER briefSummary: Delineate and evaluate the role of echocardiography in children with congenital heart disease undergoing cardiac catheterization in the pediatric cardiology unit of Assiut university hospitals.

1. To improve diagnostic accuracy by creating a systematic approach for image acquisition and interpretation across different procedural timepoints.
2. To promote consistent hemodynamic evaluations to reliably assess cardiac function and blood flow.
3. To enable optimized procedural planning and intraprocedural guidance via comprehensive delineation of anatomy and pathophysiology.
4. To facilitate standardized longitudinal monitoring after interventions to evaluate outcomes and detect complications. conditions: Echocardiography studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 67 type: ESTIMATED name: echocardiography and percutaneous cardiac catheterization measure: congenital heart defect dimensions in mm, measure: pressure gradient in mmHg across valve measure: cardiac function by measuring fraction shortening (FS) % in percent measure: cardiac function TAPSV in cm/sec sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06324890 id: 20240225 briefTitle: PET-CT Imaging Features of Meibomian Glands overallStatus: RECRUITING date: 2024-01-31 date: 2024-12-31 date: 2024-12-31 date: 2024-03-22 date: 2024-03-22 name: Zhongnan Hospital class: OTHER briefSummary: Analysis the results of Dry eye analysis results and PET-CT imaging comprehensively conditions: MGD-Meibomian Gland Dysfunction conditions: Positron-Emission Tomography conditions: Dry Eye studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED measure: Lacrimal river height measure: Tear break-up time measure: Tear-film lipid layer thickness measure: Meibomian glands two-dimensional digital infrared images sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongnan Hospital of Wuhan University status: RECRUITING city: Wuhan state: Hubei zip: 430071 country: China name: Min Ke, Doctor role: CONTACT phone: +86-18672395959 email: keminyk@163.com lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06324877 id: HREC/24/QCHQ/106030 briefTitle: Ataxia-telangiectasia: Treating Mitochondrial Dysfunction With Nicotinamide Riboside acronym: ATNAD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-10-30 date: 2025-10-30 date: 2024-03-22 date: 2024-04-18 name: The University of Queensland class: OTHER briefSummary: Study design: Single arm open-label clinical trial in ataxia-telangiectasia to test the effects of nicotinamide riboside on ataxia scales, immune function, and neurofilament light chain. Study population: 6-10 patients with Ataxia-Telangiectasia. Dose: Nicotinamide riboside 25 mg/kg/day in 3 equal divided doses.

Primary endpoint: Scales for assessment and rating of ataxia (SARA), and International Cooperative Ataxia Rating Scale (ICARS). Improvement of at least ½ standard deviation in key clinical scales which includes either; a) significant improvement in total combined scores from the SARA and ICARS scales, and /or b) significant improvements any aspects of the SARA and ICARS scales individually, especially pertaining to; Postural and gait improvements, Improved syllable speed and articulation, Improved fine motor skills.

Secondary endpoints: Serum analysis of neurofilament light chain (Nfl), Type 1 Interferon (INFs) epigenetic signature conditions: Ataxia Telangiectasia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 1. Primary objective: Single arm open-label clinical trial in ataxia-telangiectasia to test the effects of nicotinamide riboside on ataxia scales, immune function, and neurofilament light chain.
2. Secondary objectives:

   * Determine to what extent the beneficial effects ongoing of NR on NFl translate to clinical efficacy in patients with A-T.
   * Type 1 Interferon (INFs) epigenetic signature specifically the cGAS-STING pathway. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 10 type: ESTIMATED name: Nicotinamide riboside measure: Scales for assessment and rating of ataxia measure: International Cooperative Ataxia Rating Scale measure: Serum analysis of neurofilament light chain measure: Type 1 Interferon epigenetic signature measure: Quality of Life Measures sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Queensland Children's Hospital city: Brisbane state: Queensland zip: 4101 country: Australia name: David Coman, MBBS FRACP role: CONTACT phone: +610730681111 email: david.coman@health.qld.gov.au lat: -27.46794 lon: 153.02809 hasResults: False

 nctId: NCT06324864 id: 2024-00212 briefTitle: START NOW Adapted: Culturally Adapted Version of START NOW overallStatus: RECRUITING date: 2024-03-13 date: 2026-03 date: 2026-03 date: 2024-03-22 date: 2024-03-22 name: Prof. Christina Stadler class: NETWORK briefSummary: The goal of this clinical trial is to test the effectiveness of the culturally adapted skills-training START NOW in youth migrant populations. The main question it aims to answer is: Is the culturally adapted skills training START NOW more effective than treatment as usual (TAU) in reducing mental health problems in migrants? Participants will be randomly assigned to the intervention group receiving the skills training START NOW Adapted or the control group receiving TAU. Researchers will compare both groups to see if START NOW Adapted is more effective than TAU in reducing mental health problems in migrants. conditions: Depression conditions: Depression/Anxiety conditions: Anxiety conditions: Adolescent conditions: Emotion Recognition conditions: Mental Health conditions: Resilience,Psychological conditions: Refugee Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: START NOW Adapted measure: Change from baseline in symptoms of depression and anxiety at the end of the intervention measure: Change from baseline in symptoms of depression and anxiety at follow-up measure: Change from baseline in self-reported perceived stress at follow-up measure: Change from baseline in self-reported social-ecological resilience at the end of the intervention measure: Change from baseline in self-reported perceived stress at the end of the intervention measure: Change from baseline in self-reported social-ecological resilience at follow-up measure: Change from baseline in facial emotion recognition at the end of the intervention measure: Change from baseline in facial emotion recognition at follow-up sex: ALL minimumAge: 15 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: University Psychiatric Clinics Basel status: RECRUITING city: Basel state: Basel-Stadt zip: 4002 country: Switzerland name: Donja Brunner, PhD role: CONTACT phone: +410613258031 email: donja.brunner@unibas.ch name: Janine Bacher, MSc role: CONTACT phone: +410613258048 email: janine.bacher@upk.ch name: Donja Brunner, PhD role: PRINCIPAL_INVESTIGATOR lat: 47.55839 lon: 7.57327 hasResults: False

 nctId: NCT06324851 id: DROVZOEFFIPREP briefTitle: The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation overallStatus: COMPLETED date: 2023-01-01 date: 2023-08-01 date: 2024-03-01 date: 2024-03-22 date: 2024-04-08 name: University of Palermo class: OTHER name: University of Roma La Sapienza briefSummary: The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Drospirenone/Estetrol or Nomegestrol Acetate/Estradiol or Ethinylestradiol/Dienogest, in rapid preparation of endometrium for hysteroscopic polypectomy. conditions: Endometrial Polyp conditions: Endometrial Diseases studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 150 type: ACTUAL name: Drospirenone / Estetrol name: Nomegestrol Acetate / Estradiol name: Ethinylestradiol / Dienogest measure: Quality of endometrial preparation sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Andrea Etrusco city: Palermo zip: 90123 country: Italy lat: 38.13205 lon: 13.33561 facility: Marco Monti city: Rome zip: 00161 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06324838 id: 248-2021-NQ briefTitle: Extended Mesenteric Resection in Ileocecal Crohn's Disease. acronym: EXCEED overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2028-12 date: 2029-06 date: 2024-03-22 date: 2024-04-04 name: Odense University Hospital class: OTHER briefSummary: The EXCEED project aims to study the role of the mesentery in disease recurrence in Crohn's disease (CD), as evidence suggests that including the mesentery when doing ileocecal resections can significantly reduce recurrence rates. The EXCEED study is a blinded randomised clinical trial with 204 participants having ileocecal Crohn's disease requiring resection. Participants will undergo either "standard" mesocolic sparing resection or extended mesocolic resection to assess its impact on reducing recurrence at the anastomotic site. The primary endpoint is endoscopic recurrence 12 months postoperatively.

Additionally, the study aims to evaluate the efficacy of different surveillance modalities in detecting anastomotic site recurrence. These examinations will be conducted pre- and postoperatively for a cohort of 20 participants.

Through this study, we seek to understand the mesentery's role in Crohn's disease recurrence and identify effective non-invasive methods for postoperative monitoring. conditions: Crohn's Disease of Terminal Ileum studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Blinded multicenter randomized controlled clinical trial (RCT). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: This randomized controlled trial will incorporate blinding procedures, with the understanding that due to the nature of this interventional surgical study, the operating surgeon cannot be blinded. However, rigorous measures will be implemented to ensure blinding of both patients and all other participants involved in patient treatment. The description of the surgery within the patient chart will follow a standardized format, with the exception of the resection details. Where the two treatment methods diverge, a predefined, standardized text referencing the study will be inserted. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 204 type: ESTIMATED name: Standard laparoscopic ileocecal resection name: Extended laparoscopic ileocecal resection measure: Endoscopic recurrence measure: Early endoscopic recurrence measure: Clinical signs of recurrence / morbidity. measure: Difference in disease severity measure: Patient reported outcome 1 measure: Patient reported outcome 2 measure: Reoperations measure: Perioperative complications measure: Cost of treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06324825 id: 2022CR64 briefTitle: Fuzheng Nizeng Formula for Chronic Atrophic Gastritis With Low-grade Intraepithelial Neoplasia, a Multicenter Randomized Controlled Trial overallStatus: RECRUITING date: 2022-10-24 date: 2024-12-31 date: 2024-12-31 date: 2024-03-22 date: 2024-03-22 name: Peking University First Hospital class: OTHER briefSummary: Fuzheng Nizeng Formula (FZNZ) is derived from the classic formula Liujunzi Decoction. Former pilot study found that FZNZ promoted the recovery of gastric atrophy and relieve the relative symptoms. This study is to evaluate its efficacy for chronic atrophic gastritis with low-grade intraepithelial neoplasia, compared with positive control Molduodan granule. conditions: Atrophic Gastritis With Low-grade Intraepithelial Neoplasia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 144 type: ESTIMATED name: Fuzhegn Nizeng Decoction name: Moluodan granules measure: Recovery rate of Low-grade Intraepithelial Neoplasia measure: 7-point Global Overall Symptom Scale measure: Adverse event rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University First Hospital status: RECRUITING city: Beijing state: Beijing zip: 100034 country: China name: Xuezhi Zhang, Doctor role: CONTACT phone: +861083572634 email: zhang.xuezhi@263.net lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06324812 id: SSGJ-611-PED-AD-Ib/II-01 briefTitle: Evaluation of 611 in Chinese Children and Adolescents With Moderate to Severe Atopic Dermatitis overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-08 date: 2024-08 date: 2024-03-22 date: 2024-03-22 name: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. class: INDUSTRY briefSummary: The primary objective of the study was to evaluate the safety and pharmacokinetic of 611 in Chinese children and adolescents with moderate to severe atopic dermatitis. conditions: Dermatitis, Atopic studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 104 type: ESTIMATED name: Recombinant Anti-interleukin-4 Receptor Alpha Monoclonal Antibody Injection (611) measure: Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit. measure: Minimum concentration (Cmin) measure: Number of Participants with Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) measure: Number of Participants with Investigator's Global Assessment (IGA) Score of "0" or "1" and Improvement From Baseline of Greater Than or Equal to (>=) 2 Points measure: Number of Participants with Eczema Area and Severity Index (EASI) - 50 Response (>= 50% Improvement in Score From Baseline) measure: Number of Participants with Eczema Area and Severity Index (EASI) - 90 Response (>= 90% Improvement in Score From Baseline) measure: Number of Participants Who Achieved >=4 Points/ >=3 Points With Improvement From Baseline in Weekly Average of Pruritus Numerical Rating Scale (NRS) Score From Baseline measure: Percentage Change From Baseline in EASI Score measure: Change From Baseline in Percent Body Surface Area (BSA) of AD Involvement measure: Change From Baseline in Weekly Average of Pruritus NRS measure: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) measure: Change From Baseline in Patient Oriented Eczema Measure (POEM) sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06324799 id: 2023/51 briefTitle: The Effect of Position Change Frequency on Hyperbilirubinemia overallStatus: RECRUITING date: 2024-03-14 date: 2024-07-14 date: 2024-11-24 date: 2024-03-22 date: 2024-03-22 name: Tarsus University class: OTHER briefSummary: In our study, the effect of the frequency of position changes on hyperbilirubinemia in babies hospitalized in the Neonatal Intensive Care Unit and receiving phototherapy treatment will be investigated.

This study was planned as a single-center randomized controlled clinical trial to examine the effect of the frequency of position changes on the time it takes for hyperbilirubinemia to subside in babies receiving phototherapy treatment in the Neonatal Intensive Care Unit of Mersin City Training and Research Hospital.

Babies included in the study will be randomly divided into two groups by randomization method. While the babies in the study group will be subjected to position changes (supine, prone, lateral) every 2 hours, the same procedure will be applied to the control group every 6 hours. All newborns included in the study were treated with the Unitest (Blue angel) LED Phototherapy device, which is used as standard in the neonatal intensive care unit, at a distance of 25-40 cm, at a wavelength of 425-475 nm, at 45 watts, at 50/60 Hz. Phototherapy will be applied unidirectionally. During phototherapy, only the perineal area of the babies will be covered with a reduced diaper, and their eyes will be covered with a three-layer, cotton, black eye patch that transmits 99.5% of ultraviolet rays. During phototherapy sessions, the total serum bilirubin level of the patient is checked; Phototherapy will be continued until it falls below the threshold value in the Bhutani nomogram, which is evaluated according to postnatal days and risk factors. The descriptive characteristics of the babies included in the study and their total bilirubin and hematocrit values before the start of phototherapy will be recorded on the form prepared by the researchers. After phototherapy begins, position changes will be made every two hours for babies in the experimental group and every six hours for babies in the control group until the total serum bilirubin value falls below the phototherapy threshold value in the Bhutani nomogram.

Bilirubin levels will be measured and recorded by venous measurement at the sixth hour and the 24th hour, and this process will be continued regularly until the bilirubin value decreases to the normal range. This practice is performed routinely in the clinic and will not be considered specific to the study. conditions: Newborn; Vitality conditions: Hyperbilirubinemia, Neonatal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled clinical trial primaryPurpose: OTHER masking: NONE count: 64 type: ESTIMATED name: phototherapy treatment measure: Bhutani Nomogram measure: bilirubin level measure: hematocrit levels sex: ALL minimumAge: 1 Day maximumAge: 15 Days stdAges: CHILD facility: Tarsus State Hospital status: RECRUITING city: Mersin country: Turkey name: Atiye Karakul, Ass. Prof. role: CONTACT phone: 90(324) 600 00 33 phoneExt: 2231 email: atiyekarakul@gmail.com lat: 36.79526 lon: 34.61792 hasResults: False

 nctId: NCT06324786 id: 2024 IBMT NF briefTitle: Brain Mechanisms of Reducing Polysubstance Use overallStatus: RECRUITING date: 2023-09-01 date: 2026-08-31 date: 2026-08-31 date: 2024-03-22 date: 2024-03-22 name: Arizona State University class: OTHER briefSummary: The proposed study will test whether neurofeedback (NF) could optimize integrative body-mind training (IBMT) practice. conditions: Multiple Drug Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: mindfulness or/and active/sham neurofeedback primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 35 type: ESTIMATED name: IBMT name: NF measure: Intervention effects on brain function using Functional Magnetic Resonance Imaging (fMRI) measure: Intervention effects on brain white matter using fMRI measure: Intervention effects on brain grey matter using fMRI measure: Intervention effects on addiction behavior using substance use questionnaires in PhenX Toolkit sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: YiYuan Tang status: RECRUITING city: Phoenix state: Arizona zip: 85004 country: United States name: YiYuan Tang role: CONTACT phone: 480-790-3577 email: yiyuan@asu.edu lat: 33.44838 lon: -112.07404 hasResults: False

 nctId: NCT06324773 id: 9867 briefTitle: Prevalence of Postpartum Family Planning and Its Association With Spousal Joint Decision-Making in Family Planning overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-20 date: 2024-06-30 date: 2024-03-22 date: 2024-03-22 name: Aga Khan University class: OTHER briefSummary: This community-based cross-sectional study investigates the prevalence of postpartum family planning (PPFP) uptake and its association with joint spousal family planning decision-making among married women in rural Sindh, Pakistan. The study, conducted in Thatta District with a population of approximately 0.98 million people, addresses sociodemographic challenges including high fertility rates, maternal and newborn mortality, and low contemporary contraception use. Targeting married women aged 18-49 who gave birth within the past year, the research utilizes data from the Global Network's Maternal and Newborn Health Registry. Data collection involves a pretested questionnaire administered by trained female data collectors. Statistical analysis includes descriptive statistics and logistic regression using STATA 17. The study aims to fill knowledge gaps regarding factors influencing PPFP uptake, particularly the role of joint decision-making in family planning. Findings could inform targeted interventions to enhance maternal and child health, contribute to existing knowledge, and guide policymakers and healthcare providers in addressing the unmet need for family planning in rural Pakistan. conditions: Postpartum Family Planning studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 510 type: ESTIMATED measure: Prevalence of Postpartum Family Planning Uptake measure: Frequency of spousal joint decision making for uptake of postpartum family planning measure: Comparison between spousal joint decision making is using postpartum family planning method and non-users. sex: ALL minimumAge: 15 Years maximumAge: 49 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06324760 id: LIPOICSPI2018 briefTitle: Alpha-lipoic Acid Combined With B Vitamins Shows Promise for Treating Restless Legs Syndrome overallStatus: COMPLETED date: 2020-03-04 date: 2021-06-02 date: 2021-06-02 date: 2024-03-22 date: 2024-03-22 name: Uriach Consumer Healthcare class: INDUSTRY briefSummary: Investigating Tiobec® 400's efficacy in alleviating Restless Legs Syndrome symptoms sheds light on promising therapeutic avenues. conditions: Restless Legs Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ACTUAL name: Alpha-lipoic acid combined with B vitamins measure: Measure the subjective RLS symptoms of the participants through the IRLSSG rating scale (IRLS) measure: Anthropometric parameters of the patients. measure: Patients' body measurements measure: Measurements of patient anatomy measure: Patients' body characteristics. measure: Measurements of patient anatomy. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Center Teknon city: Barcelona zip: 08017 country: Spain lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06324747 id: 23-046 briefTitle: Soft Tissue Stability in Immediate Implant Placement Using (VST) Versus Conventional Flap in Type II Extraction Sockets overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-23 date: 2024-10-01 date: 2024-12-01 date: 2024-03-22 date: 2024-03-22 name: British University In Egypt class: OTHER briefSummary: This study compare between the vestibular socket therapy (VST) and the traditional mucoperiosteal flap reflection in immediate implant placement in type II extraction socket in the esthetic zone.

The technique of vestibular socket therapy (VST), introduced by Elaskry, enables the placement of implants immediately while simultaneously rehabilitating the entire socket, resulting in excellent esthetic and functional outcomes that meet the expectations of patients. VST involves socket augmentation through a minimally invasive vestibular access incision, eliminating the need for the traditional mucoperiosteal flap reflection, regardless of the extent of socket compromise. conditions: Badly Broken Tooth in a Socket Type II Eligible to be Replaced by Immediate Implant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two equal parallel groups with a 1:1 allocation ratio to receive either vestibular socket therapy (test group) or to be treated with conventional mucoperiosteal flap (control group). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Due to the differences in techniques, the operating surgeon can not be blinded to the procedure whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 16 type: ACTUAL name: Vestibular socket therapy name: conventional full thickness flap measure: Soft Tissue Stability measure: Bone Regeneration measure: Pink Esthetic Score (PES) sex: ALL minimumAge: 21 Years maximumAge: 55 Years stdAges: ADULT facility: The British university in Egypt city: Cairo state: New Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06324734 id: D0817R00082 briefTitle: Assessment of Safety of Olaparib in Chinese Patients With Ovarian Cancer in the Real-World Setting overallStatus: NOT_YET_RECRUITING date: 2024-03-19 date: 2024-07-31 date: 2024-07-31 date: 2024-03-22 date: 2024-03-22 name: AstraZeneca class: INDUSTRY briefSummary: Study D0817R00081 is a retrospective study using NCID database to assess the safety of Olaparib in Chinese patients with ovarian cancer by examining the incidence, seriousness, and severity of all AEs, including but not limiting to AESIs and SAEs, AEs related to Olaparib, and AEs leading to dose reduction, interruption or discontinuation of Olaparib. The first Olaparib prescription date will be set as the index date. The baseline period is from the patient's first ovarian cancer diagnosis recorded in the database to the patient's first treatment with Olaparib (as early as the database start date of January 1, 2013) to the index date for derivation of lines of therapy or one year pre-index date for other baseline variables. Patients will be followed until the patient's last medical record in the database, 30 days after the last dose of Olaparib, death, or June 30, 2023, whichever comes first. All patients who meet the inclusion/exclusion criteria will be enrolled. conditions: Using NCID Database to Assess the Safety of Olaparib in Chinese Patients With Ovarian Cancer by Examining the Incidence, Seriousness, and Severity of All AE studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 3000 type: ESTIMATED measure: The incidence, seriousness, and severity of all AEs measure: The number and proportion of patients according to different baseline demographics and characteristics measure: Overall number and proportion of patients with olaprib combination maintenance therapy in PSR patients measure: Overall number and proportion of patients with olap arib combination maintenance therapy in 1L patients 2) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06324721 id: S68133 briefTitle: Why do Patients Report Lymphedema After Breast Cancer Treatment Without an Objective Measurable Swelling acronym: LymphSens overallStatus: RECRUITING date: 2024-03-26 date: 2027-03 date: 2027-03 date: 2024-03-22 date: 2024-04-26 name: Universitaire Ziekenhuizen KU Leuven class: OTHER name: Universiteit Antwerpen briefSummary: Breast cancer related lymphedema (BCRL) is due to its chronicity and impact an extremely dreaded complication after breast cancer treatment.

The prevalence rate of objective arm and trunk/ breast BCRL is declining due to the major shift into the treatment approach of breast cancer. However, the prevalence rate of subjective arm and trunk/ breast BCRL is much higher than that of objective BCRL. Subjective BCRL is defined as the diagnosis of BCRL based on the patient's sensation of a difference in size at the arm and/or trunk without any objectively measurable swelling.

At this moment, it is not clear how many breast cancer patients experience subjective arm or trunk/breast BCRL and what the underlying mechanisms may be. Therefore, the investigators hypothesize that four mechanisms might be associated with the presence and the severity of subjective arm or trunk/breast BCRL, including sensory processing problems (1. nociceptive and/or 2. neuropathic and/or 3. central) and the presence of disturbed lymphatic transport without clinical manifestation (4. subclinical BCRL).

The investigators will set up a prospective longitudinal study with breast cancer patients to determine the prevalence of subjective and objective arm or trunk/ breast BCRL at 1, 6. and 12 month(s) post-surgery and the transitions between the different types of BCRL and to compare the amount of swelling at arm or trunk/ breast, the presence or severity of subclinical BCRL and peripheral and central sensory processing problems between patients with different types of BCRL. In addition, the present study will be undertaken to determine the contributing factors to the severity of subjective arm or trunk/ breast BCRL within the group of patients with subjective BCRL at different time-points after surgery (at 1, 6. and 12 month(s) post-surgery). conditions: Breast Cancer conditions: Lymphedema conditions: Sensory Processing Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective cohort study primaryPurpose: SCREENING masking: NONE count: 230 type: ESTIMATED name: Oedema measurements and sensory evaluations measure: Presence of self-reported swelling at arm measure: Presence of self-reported swelling at trunk measure: Presence of self-reported swelling at breast measure: Presence of subjective arm lymphedema measure: Presence of subjective trunk lymphedema measure: Presence of subjective breast lymphedema measure: Relative hand volume difference measure: Relative arm volume difference measure: Extra-cellular water ratio by Bioimpedance Analysis measure: Extra-cellular water ratio by Bioimpedance Spectroscopy measure: Presence of objective arm lymphedema measure: Relative percentage of water content (PWC) ratio measure: Skin thickness measure: Presence of objective trunk lymphedema measure: Presence of objective breast lymphedema measure: Dermal rerouting score at arm measure: Dermal rerouting score at trunk measure: Severity of myofascial adhesions measure: Myofascial tissue stiffness measure: Pressure pain thresholds measure: Arm abduction range measure: Presence of neuropathic pain measure: Mechanical detection thresholds measure: Thermal detection and pain thresholds measure: Sensory acuity measure: Dysfunctional inhibitory pain mechanism measure: Enhanced facilitating mechanism measure: Body perception measure: Severity of subjective arm lymphedema measure: Severity of subjective trunk lymphedema measure: Severity of subjective breast lymphedema sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals of Leuven, center for lymphedema status: RECRUITING city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium name: Nele Devoogdt role: CONTACT email: nele.devoogdt@uzleuven.be name: Ceren Gursen role: CONTACT email: ceren.guersen@kuleuven.be lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06324708 id: THA_DXA briefTitle: Analysis of Defined Elements on DXA in Patients Undergoing Hip Arthroplasty acronym: THA_DXA overallStatus: RECRUITING date: 2023-02-07 date: 2024-10-31 date: 2025-10-31 date: 2024-03-22 date: 2024-03-22 name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio class: OTHER briefSummary: The purpose of this study is to investigate the role of two-dimensional FEM models obtained from DXA images in the longitudinal assessment of periprosthetic bone, in subjects undergoing hip arthroplasty. Specifically, the study will focus on the joint analysis of changes in the parameters of bone mineral density (BMD) and Bone Strain Index (BSI) at the level of periprosthetic bone of the proximal femur in patients undergoing hip replacement surgery using DXA, evaluating the densitometric variation of these two parameters over time, starting from an immediately postoperative data and checking the change at 6 months to follow the patient through the postoperative course conditions: Bone Resorption conditions: Arthroplasty Complications studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 69 type: ESTIMATED name: DXA measure: Role of two-dimensional FEM models obtained from DXA images in longitudinal evaluation of periprosthetic bone measure: Role of two-dimensional FEM models of bone resistance to loading measure: Identification of mechanical stress measure: Assesment with PROMs: VAS measure: Assesment with PROMs; HHS measure: Assesment with PROMs: SF12 measure: Assesment with PROMs: HOOS PS sex: ALL minimumAge: 50 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale Galeazzi-Sant'Ambrogio status: RECRUITING city: Milan zip: 20173 country: Italy name: Laura Mangiavini role: CONTACT phone: 0283506790 email: laura.mangiavini@unimi.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06324695 id: 01GY2105 briefTitle: Development and EValuation of an Online Intervention to Reduce Self-Stigma in People With Visible Chronic Skin disEases acronym: DEVISE overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2025-03 date: 2024-03-22 date: 2024-03-22 name: Universitätsklinikum Hamburg-Eppendorf class: OTHER name: German Federal Ministry of Education and Research briefSummary: This project aims to develop and evaluate an online intervention to prevent and/or reduce self-stigma in German patients with visible chronic skin diseases. Evaluation of the intervention with regard to effectiveness and feasibility will follow an open-label randomized controlled design with 550 patients in total. The results of the program are expected to provide new insights and markedly extended knowledge on the mechanisms of self-stigma in chronic skin conditions. The new online intervention can be used in routine care, aiming for better patient care in practice and, ultimately decreased extent of self-stigma, increased quality of life of patients, and decreased rates of depression, anxiety, and suicide ideation. conditions: Psoriasis conditions: Alopecia Areata conditions: Hidradenitis Suppurativa conditions: Vitiligo conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 550 type: ESTIMATED name: HautKompass measure: Changes from baseline to post-intervention and follow-up in self-stigma measure: Changes from baseline to post-intervention and follow-up in generic quality of life measure: Changes from baseline to post-intervention and follow-up in skin-generic quality of life measure: Changes from baseline to post-intervention and follow-up in depression measure: Changes from baseline to post-intervention and follow-up in anxiety measure: Changes from baseline to post-intervention and follow-up in suicidal ideation measure: Feasibility of the HautKompass online program measure: Feasibility of the HautKompass online program - dropouts measure: User satisfaction with the HautKompass online program measure: Acceptability of the HautKompass online program measure: Changes from baseline to post-intervention and follow-up in illness identity measure: Changes from baseline to post-intervention and follow-up in avoidance and acceptance coping measure: Changes from baseline to post-intervention and follow-up in generic body image/ appearance concerns measure: Changes from baseline to post-intervention and follow-up in cutaneous body image measure: Changes from baseline to post-intervention and follow-up in self-compassion measure: Session Feedback sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Deutscher Vitiligo-Bund e.V. city: Adelsdorf zip: 91325 country: Germany name: Georg Pliszewski role: CONTACT phone: 040 23532891 email: mail@vitiligo-bund.de lat: 49.47022 lon: 10.68522 facility: Fachklinik Bad Bentheim, Fachbereich Dermatologie und Allergologie city: Bad Bentheim zip: 48455 country: Germany name: Athanasios Tsianakas, PD Dr.med. role: CONTACT phone: 05922 74-0 email: info@fk-bentheim.de lat: 52.30077 lon: 7.15767 facility: Universitätsklinikum der Ruhr-Universität Bochum (UKRUB), Klinik für Dermatologie, Venerologie und Allergologie city: Bochum zip: 44791 country: Germany name: Falk Bechara, Prof.Dr.med. role: CONTACT phone: 0234 509 6079 email: stephanie.pazia@kklbo.de lat: 51.48165 lon: 7.21648 facility: Universitätsklinikum Hamburg-Eppendorf (UKE), Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP) city: Hamburg zip: 20246 country: Germany name: Matthias Augustin, Prof.Dr.med. role: CONTACT phone: +49 (0) 40 7410 55428 email: m.augustin@uke.de lat: 53.57532 lon: 10.01534 facility: Deutscher Psoriasis Bund e.V. (DPB) city: Hamburg zip: 20359 country: Germany name: Marius Grosser role: CONTACT phone: 040 2233990 email: info@psoriasis-bund.de lat: 53.57532 lon: 10.01534 facility: Hautarztpraxis Dr. Daniela Kasche city: Hamburg zip: 22549 country: Germany name: Daniela Kasche, Dr. med. role: CONTACT phone: 040 866 47 77 00 email: praxis@dr-kasche.de lat: 53.57532 lon: 10.01534 facility: Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Venerologie und Allergologie, Psoriasis-Zentrum-Kiel city: Kiel zip: 24105 country: Germany name: Sascha Gerdes, Prof.Dr.med. role: CONTACT phone: 0431 500 21102 email: ssievers@dermatology.uni-kiel.de lat: 54.32133 lon: 10.13489 facility: Alopecia Areata Deutschland e.V. city: Krefeld zip: 47701 country: Germany name: Claudia Stenders role: CONTACT phone: 02151 786006 email: info@kreisrunderhaarausfall.de lat: 51.33645 lon: 6.55382 facility: Universitätsmedizin der Johannes-Gutenberg-Universität Mainz, Hautklinik und Poliklinik city: Mainz zip: 55131 country: Germany name: Petra Staubach-Renz, Prof.Dr.med. role: CONTACT phone: 06131 175244 phoneExt: 175732 email: petra.staubach@unimedizin-mainz.de lat: 49.98419 lon: 8.2791 facility: Technische Universität München, Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein city: München zip: 80802 country: Germany name: Alexander Zink, PD Dr.med. role: CONTACT phone: 089 4140 3038 email: alexander.zink@tum.de lat: 48.13743 lon: 11.57549 facility: Universitätsklinikum Münster (UKM), Klinik für Hautkrankheiten - Allgemeine Dermatologie und Venerologie city: Münster zip: 48149 country: Germany name: Sonja Ständer, Prof.Dr.med. role: CONTACT phone: 0251 8357458 email: sonja.staender@ukmuenster.de lat: 51.96236 lon: 7.62571 facility: Dermatologische Spezial- und Schwerpunktpraxis Dr. med. Ralph von Kiedrowski city: Selters zip: 56242 country: Germany name: Ralph von Kiedrowski, Dr. med. role: CONTACT phone: 02626 900775 email: dr.vonkiedrowski@cmss-selters.de lat: 50.51681 lon: 8.28953 facility: Privatpraxis Dr. med. Matthias Hoffmann city: Witten zip: 58453 country: Germany name: Matthias Hoffmann, Dr. med. role: CONTACT phone: 02302 56060 email: service@hautarzt-dr-hoffmann.de lat: 51.44362 lon: 7.35258 hasResults: False

 nctId: NCT06324682 id: 825/2022/Oss/AOUFe briefTitle: ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing acronym: TREEBEARD overallStatus: RECRUITING date: 2023-01-01 date: 2033-12-31 date: 2034-12-31 date: 2024-03-22 date: 2024-03-22 name: University Hospital of Ferrara class: OTHER briefSummary: The goal of this observational study is to evaluate the clinical characteristics of patients undergoing permanent cardiac pacing and to compare procedural efficacy and safety of different implantation approaches in the clinical practice of the participating centres. The contribution of non-fluoroscopic anatomical and electrophysiological reconstruction systems to device implantation procedures will also be evaluated.

Participants \[patients over 18 years old with an indication to receive a definitive pacemaker/intracardiac defibrillator implant\] will receive a permanent cardiac pacing implant as requested according to European Society of Cardiology (ESC) guidelines; the investigators will evaluate procedural efficacy and safety of different implantation approaches. conditions: Arrhythmias, Cardiac conditions: Atrioventricular Block conditions: Reduced Systolic Function conditions: Atrial Fibrillation conditions: Bradyarrhythmia conditions: Ventricular Tachycardia conditions: Ventricular Dysfunction conditions: Ventricular Fibrillation conditions: Ventricular Arrythmia conditions: Atrioventricular Nodal Disease conditions: Atrioventricular Conduction Defects conditions: Atrioventricular Block Complete conditions: Atrioventricular Block Incomplete conditions: Atrioventricular Junctional Rhythm conditions: Bundle-Branch Block conditions: Left Bundle-Branch Block conditions: Heart Failure, Systolic conditions: Block;Atrioventricular conditions: Block; Arrhythmic conditions: Block; Mobitz conditions: Block, Heart conditions: Block, Fascicular conditions: Block Branch Bundle Left conditions: Heart Failure，Congestive conditions: Heart Arrhythmia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 8400 type: ESTIMATED name: Cardiac pacing - Conventional RV pacing name: Cardiac pacing - Conduction System Pacing name: Cardiac pacing - Cardiac resynchronization therapy (pacing - CRTP - or defibrillation - CRTD) name: Cardiac pacing - Epicardial pacing name: Cardiac pacing - Leadless pacing measure: 30 days efficacy measure: Rate of hospitalizations for heart failure at 12 months measure: All cause death at 12 months measure: All cause and cardiovascular death at 1, 3, 5, 10 years measure: Onset/worsening of heart failure measure: Onset/worsening of atrial tachyarrhythmias measure: Onset/worsening of ventricular tachyarrhythmias measure: Procedural time measure: Fluoroscopy time measure: Radiation exposure measure: Success rate of CRT in heart failure measure: Cardiac perforation rate measure: Hemothorax rate measure: Pneumothorax rate measure: Pocket hematoma rate measure: Pericardial effusion rate measure: Lead dislocation rate measure: Lead fracture rate measure: Cardiac Implantable Electronic Devices infections rate measure: Reintervention rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliero-Universitaria di Ferrara status: RECRUITING city: Ferrara state: FE zip: 44124 country: Italy name: Matteo Bertini, MD, PhD role: CONTACT phone: +390532236269 email: brtmtt2@unife.it lat: 44.83804 lon: 11.62057 facility: Ospedale San Donato status: RECRUITING city: Arezzo country: Italy name: Pasquale Notarstefano, MD role: CONTACT lat: 43.46276 lon: 11.88068 facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi Bologna status: RECRUITING city: Bologna zip: 40138 country: Italy name: Mauro Biffi, MD role: CONTACT lat: 44.49381 lon: 11.33875 facility: spedale Maggiore di Bologna status: RECRUITING city: Bologna country: Italy name: Valeria Carinci, MD role: CONTACT lat: 44.49381 lon: 11.33875 facility: Ospedale Bernardino Ramazzini status: RECRUITING city: Carpi country: Italy name: Elia De Maria, MD role: CONTACT lat: 44.78237 lon: 10.8777 facility: Ospedale SS Annunziata status: RECRUITING city: Cento country: Italy name: Biagio Sassone, MD role: CONTACT lat: 44.73099 lon: 11.28716 facility: Ospedale Bufalini status: RECRUITING city: Cesena country: Italy name: Paolo Sabbatani, MD role: CONTACT lat: 44.1391 lon: 12.24315 facility: Ospedale San Giuseppe status: RECRUITING city: Empoli country: Italy name: Attilio Del Rosso, MD role: CONTACT lat: 43.71795 lon: 10.94758 facility: Ospedale di Vaio status: RECRUITING city: Fidenza country: Italy name: Paolo Pastori role: CONTACT lat: 44.86694 lon: 10.06039 facility: Azienda Ospedaliero-Universitaria Careggi status: RECRUITING city: Firenze country: Italy name: Giuseppe Ricciardi, MD role: CONTACT lat: 43.77925 lon: 11.24626 facility: Ospedale San Giovanni di Dio status: RECRUITING city: Firenze country: Italy name: Iacopo Bertolozzi, MD role: CONTACT lat: 43.77925 lon: 11.24626 facility: Ospedale Santa Maria Annunziata Bagno a Ripoli status: RECRUITING city: Firenze country: Italy name: Maria Giaccardi, MD role: CONTACT lat: 43.77925 lon: 11.24626 facility: Azienda Ospedaliero-Universitaria "Ospedali Riuniti" status: RECRUITING city: Foggia country: Italy name: Pier Luigi Pellegrino, MD role: CONTACT lat: 41.45845 lon: 15.55188 facility: Ospedale Morgagni-Pierantoni status: RECRUITING city: Forlì country: Italy name: Alberto Bandini, MD role: CONTACT lat: 44.22177 lon: 12.04144 facility: Ospedale Santa Maria della Misericordia Grosseto status: RECRUITING city: Grosseto country: Italy name: Gennaro Miracapillo, MD role: CONTACT lat: 42.76296 lon: 11.10941 facility: Ospedale della Versilia status: RECRUITING city: Lido Di Camaiore country: Italy name: Gianluca Solarino, MD role: CONTACT lat: 43.90012 lon: 10.2269 facility: Ospedali Riuniti di Livorno status: RECRUITING city: Livorno country: Italy name: Federica Lapira, MD role: CONTACT lat: 43.54427 lon: 10.32615 facility: Ospedale San Luca status: RECRUITING city: Lucca country: Italy name: Davide Giorgi, MD role: CONTACT lat: 43.84369 lon: 10.50447 facility: Nuovo ospedale Apuano Massa status: RECRUITING city: Massa country: Italy name: Giuseppe Arena, MD role: CONTACT lat: 44.03541 lon: 10.13927 facility: Azienda Ospedaliero-Universitaria Policlinico di Modena status: RECRUITING city: Modena country: Italy name: Giuseppe Boriani, PhD role: CONTACT lat: 44.64783 lon: 10.92539 facility: Ospedale Sant'Agostino Estense Modena Baggiovara status: RECRUITING city: Modena country: Italy name: Mauro Zennaro, MD role: CONTACT lat: 44.64783 lon: 10.92539 facility: Ospedale Civico, azienda Ospedaliera di Palermo status: RECRUITING city: Palermo country: Italy name: Giuseppe Sgarito, MD role: CONTACT lat: 38.13205 lon: 13.33561 facility: Policlinico Paolo Giaccone status: RECRUITING city: Palermo country: Italy name: Giuseppe Coppola, MD role: CONTACT lat: 38.13205 lon: 13.33561 facility: Azienda Ospedaliero-Universitaria Maggiore status: RECRUITING city: Parma country: Italy name: Francesca Maria Notarangelo, MD role: CONTACT lat: 44.79935 lon: 10.32618 facility: Ospedale Guglielmo da Saliceto Piacenza status: RECRUITING city: Piacenza zip: 29100 country: Italy name: Luca Rossi, MD role: CONTACT lat: 45.05242 lon: 9.69342 facility: Azienda Ospedaliero-Universitaria pisana Cisanello status: RECRUITING city: Pisa country: Italy name: Giulio Zucchelli role: CONTACT lat: 43.70853 lon: 10.4036 facility: Fondazione Toscana Gabriele Monasterio status: RECRUITING city: Pisa country: Italy name: Andrea Rossi, MD role: CONTACT lat: 43.70853 lon: 10.4036 facility: Ospedale Santa Maria delle Croci status: RECRUITING city: Ravenna country: Italy name: Alessandro Dal Monte role: CONTACT lat: 44.41344 lon: 12.20121 facility: ASMN Reggio Emilia status: RECRUITING city: Reggio Emilia country: Italy name: Fabio Quartieri, MD role: CONTACT lat: 44.69825 lon: 10.63125 facility: Ospedale degli Infermi Rimini status: RECRUITING city: Rimini country: Italy name: Davide Saporito, MD role: CONTACT lat: 44.05755 lon: 12.56528 facility: Azienda Ospedaliero-Universitaria Senese status: RECRUITING city: Siena country: Italy name: Amato Santoro, MD role: CONTACT lat: 43.31822 lon: 11.33064 hasResults: False

 nctId: NCT06324669 id: 4765060 briefTitle: The Effect of a Ketone Drink on Blood Glucose Levels in People With Type 2 Diabetes overallStatus: RECRUITING date: 2024-03-16 date: 2025-01-31 date: 2026-01-31 date: 2024-03-22 date: 2024-03-22 name: University of Exeter class: OTHER name: University of British Columbia name: Medical Research Council briefSummary: Ketones are naturally produced by our body and can affect our blood sugar levels. Ketones could be important in the treatment of type 2 diabetes (T2D). The purpose of this research is to determine if a ketone drink can lower blood sugar in people with T2D following a meal. This research will provide new knowledge about the regulation of blood sugar. This may also inform if ketone drinks could be used as a treatment for T2D. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomised cross over trial counterbalanced for trial order primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE maskingDescription: Coded, known only to independent individual whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 15 type: ESTIMATED name: Ketone supplement name: Placebo supplement measure: Rate of endogenous glucose production measure: Total rate of glucose appearance measure: Exogenous glucose rate of appearance measure: Total rate of glucose disappearance measure: Rate of gluconeogenesis measure: Rate of glycogenolysis measure: Beta-cell function measure: Insulin concentration measure: Glucagon concentration measure: GLP-1 concentration measure: GIP concentration measure: Glycerol concentration measure: Free fatty acid concentration measure: Ketone concentration measure: Energy expenditure sex: ALL minimumAge: 41 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sport & Health Sciences University of Exeter status: RECRUITING city: Exeter state: Devon zip: EX1 2LU country: United Kingdom name: Francis B Stephens, PhD role: CONTACT phone: +441392 722157 phoneExt: 2157 email: f.b.stephens@exeter.ac.uk lat: 50.7236 lon: -3.52751 hasResults: False

 nctId: NCT06324656 id: PRP-PNS briefTitle: The Efficacy of Combining Platelet-rich Plasma With Crystallized Phenol in Pilonidal Sinus Disease overallStatus: RECRUITING date: 2023-11-21 date: 2024-04-30 date: 2024-05-30 date: 2024-03-22 date: 2024-03-22 name: Necmi Kadıoğlu Hospital class: OTHER briefSummary: The use of local liquid phenol for pilonidal sinus disease was first introduced by Maurica and Greenwood in 1964. Phenol, also known as carbolic acid, has been proven to be an effective sclerosing agent for treating pilonidal sinus diseas. Its antiseptic and anesthetic qualities make it suitable for application in awake patients under local anesthesia. The treatment of pilonidal sinus diseas in children with crystallized phenol was first published by Ateş et al in 2018. However, the treatment involving only crystallized phenol can require numerous sessions, potentially extending the duration of the treatment. IIn this study, the investigators, investigated whether the application of platelet-rich plasma following crystallized phenol treatment could accelerate the healing process and reach better outcomes. This study evaluates the efficacy of PRP as a treatment modality for pilonidal sinus disease in pediatric patients. conditions: Pilonidal Sinus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: crystallized phenol + platelet rich plasma application name: crystallized phenol measure: Average time to full daily activities measure: VAS scores measure: Healing time measure: Cosmetic score measure: Success rate measure: Recurrence rate measure: Bleeding rate measure: Infection rate measure: Skin burn rate measure: Total complication rate sex: ALL minimumAge: 1 Day maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Mustafa Azizoğlu status: RECRUITING city: Istanbul zip: 34430 country: Turkey name: Mustafa Azizoğlu role: CONTACT phone: +905447448244 email: mdmazizoglu@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06324643 id: Erb's Palsy briefTitle: Sensory Motor Integration Training in Erb's Palsy Childern overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-03-22 date: 2024-03-22 name: Sara Elsayed Ali Abdelnaby Ali class: OTHER briefSummary: The aim of the study is to Study effect of sensory motor integration training on ADL activities in children with Erb's palsy. conditions: Sensory Motor Integration and Erb's studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 35 type: ESTIMATED name: sensory motor integration training measure: Effect of sensory motor integration training on ADL sex: ALL minimumAge: 2 Years maximumAge: 6 Years stdAges: CHILD hasResults: False

 nctId: NCT06324630 id: 24FIM1266996 briefTitle: Implementation of Innovative Food Prescription Programs in Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-06-30 date: 2024-03-22 date: 2024-04-26 name: University at Buffalo class: OTHER briefSummary: In the USA, about 10% of grown-ups have a hard time finding healthy food, like fruits and vegetables. It's even harder for older grown-ups who might be sick and find it tricky to move around, which makes it tough to get healthy food. The investigators are trying to fix this by testing two new ways to help older people (aged 65 and up) get nutritious food. The investigators are getting lots of help and ideas from older adults to make these ways work the best they can.

The study is happening at the Erie County Medical Center (ECMC) in the East Side of Buffalo, NY, where many African Americans live. This place hasn't been treated fairly, so there aren't many places to buy fresh fruits and vegetables in the local stores. On the ECMC campus, there are three clinics that can help people who can't easily get healthy food. Every participant in our study will be put into one of three programs, each lasting 12 weeks, and they will get food every week.

In the "usual care" program, a doctor writes an order, and the participant gets a voucher to buy more fruits and vegetables at a market or store.

In the "delivery of a produce prescription box" program, a box of fruits and vegetables is brought to the participant's home. The participant can pick what they like online or by calling a helper. If they don't pick, they get a regular box.

In the "delivery of a meal kit box" program, the participant gets the ingredients for three meals in a box. The participant can pick three meals they like online or by calling. If the participant doesn't pick, three meals will be chosen for the participant.

For the second and third programs, participants will get messages to remind the participant when to choose their food, when the time to choose is almost up, and when their food is on its way. If a participant can't use messages or the internet, they can call a helper for support. The investigators believe the study will show that these ways can help older adults who have a hard time getting food to eat more fruits and vegetables. The investigators will also find out which way works best compared to the usual way in the Buffalo, NY area. conditions: Food Preferences conditions: Food Habits studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 75 type: ESTIMATED name: Produce Prescription Delivery name: Healthy Meal Kit Delivery name: Produce Prescription Mobile Market measure: Program Redemption measure: Program Usage measure: Program Interest by Consenting to Being Contacted/Voiced Interest to Recruiter measure: Program Enrollment measure: Fruit and Vegetable Consumption measure: Nutrition Security measure: Self-Efficacy to Purchase, Prepare, and Eat Fresh Fruits and Vegetables measure: Barriers to Eating Fruits and Vegetables measure: Health Status and Disease Risk measure: Quality of Life in Older Age sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06324617 id: soh-Med-24-02-06MS briefTitle: Treatment of Failed Carpal Tunnel Syndrome by Dorsal Ulnar Artery Perforator Adipofascial Flap overallStatus: RECRUITING date: 2024-03-01 date: 2025-12-30 date: 2025-12-30 date: 2024-03-22 date: 2024-03-22 name: Sohag University class: OTHER briefSummary: Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the general population. Surgical treatment by open or endoscopic carpal tunnel release (CTR) is the first choice of treatment and has clinical success rates of 75% to 90%.The rate of recurrence after primary median nerve release is 3-19% \[1,2\]. Between 0.3% and 12% of cases require surgical revision \[2,3\]. The risk factors for surgical revision for secondary release are male gender, staged or simultaneous bilateral carpal tunnel release, endoscopic release, smoking and rheumatoid arthritis.

Treatment failures after primary CTR are classified as persistent CTS, recurrent CTS, or new symptoms. Recurrent symptoms are uncommon and are defined by a symptom-free interval after surgery. Persistent symptoms are relatively common, particularly in elderly patients and in patients with concurrent nerve compression or medical conditions that affect nerve function, such as diabetes. Persistent or recurrent CTS principally results from incomplete release of the transverse carpal ligament but may be accompanied by perineural scarring, leading to compression or tethering of the median nerve.

New symptoms may be caused by iatrogenic nerve injury. Surgical treatment of recurrent or persistent CTS after primary CTR usually involves open revision CTR, extended proximally into unscarred tissue, and has also included internal or external neurolysis. Unsatisfactory results following revision CTR are common.

A second compression site, or double-crush syndrome, may clinically present as RCTS or PCTS . Thorough preoperative clinical examination may uncover signs of a second compression site, which can then be confirmed on electroneuromyography (ENMG) of the entire arm.

To improve outcomes of revision CTR, recent studies have emphasized the importance of median nerve coverage by well-vascularized soft tissue to enhance nerve healing, to prevent tethering in surrounding scar tissue, and to optimize nerve gliding in the carpal tunnel. Several local flaps (hypothenar fat pad flap, tenosynovial flap), regional flaps (posterior interosseous artery flap, reverse radial artery fascial flap, flexor digitorum superficialis flap), and free flap techniques have been described, but consensus for specific flap has not been reached. Following potential iatrogenic median nerve injury and reexploration for a painful neuroma incontinuity, flap coverage may also be beneficial.

In 1988, Becker and Gilbert introduced a Fasciocutaneous pedicled flap based on a consistent dorsal perforator of the ulnar artery (absent in 1 % of population) named the dorsal ulnar artery (DUA) flap or simply the Becker flap. The authors described open revision CTR with nerve coverage by a DUA flap in 3 patients with recurrent CTS and reported good results as well as a quick and easy-to-perform dissection with low donor site morbidity and preservation of the radial andulnar artery. Since this introduction, additional studies describing fasciocutaneous DUA flaps have mostly focused on its use for reconstruction of hand or wrist wounds. Despite the original described benefits, additional studies of DUA flaps for the treatment of recurrent or persistent CTS have remained limited. conditions: Failed Carpal Tunnel Syndrome Surgery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Treatment of failed carpal tunnel syndrome by dorsal ulnar artery perforator adipofascial flap measure: Pain visual analogue scale (VAS) measure: Two point discrimination test measure: Tinel sign sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Sohag university Hospital status: RECRUITING city: Sohag country: Egypt name: Magdy M Amin, professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06324604 id: MT-101-101 briefTitle: Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2025-12 date: 2024-03-22 date: 2024-03-22 name: Mozart Therapeutics Australia Pty Ltd class: INDUSTRY briefSummary: First in human study to understand the potential side effects of MTX-101, how long MTX-101 lasts in the human body, and how MTX-101 affects specific human immune cells. conditions: Healthy Volunteers conditions: Celiac Disease conditions: Type 1 Diabetes studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Part A will enroll Healthy Adult Volunteers will be randomized, double-blind, placebo-controlled, single ascending dose (SAD), randomized to MTX-101 or placebo in a 1:1 ratio for the first 2 participants (sentinel dosing) and a 3:1 ratio thereafter. Participants in the multiple ascending dose (MAD) will be randomized in a 3:1 ratio and be dosed on Days 1 and 22 for a total of 2 doses.

Part B of this study plans to enroll at least 24 (up to 40) participants with Celiac Disease or Type 1 Diabetes, randomized in a 1:1 ratio, in a crossover design, dosed with MTX-101 or placebo on Days 1 and 22 for a total of 2 doses primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 96 type: ESTIMATED name: Placebo name: MTX-101 measure: Safety of single, ascending dose levels of MTX-101 measure: Safety of multiple, ascending dose levels of MTX-101 measure: pharmacokinetics (PK) of MTX-101 measure: pharmacokinetics (PK) of MTX-101 measure: pharmacokinetics (PK) of MTX-101 measure: anti-drug antibody (ADA) formation measure: pharmacodynamics (PD) of MTX-101 measure: Receptor occupancy of MTX-101 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nucleus Network Brisbane city: Herston state: Queensland zip: 4006 country: Australia name: Gloria Wong, MD role: CONTACT phone: 1800243733 email: brisbane@nucleusnetwork.com name: Gloria Wong, MD role: PRINCIPAL_INVESTIGATOR lat: -27.44453 lon: 153.01852 hasResults: False

 nctId: NCT06324591 id: RISKCROHNBIOM briefTitle: Observational Prospective Study to Identify Intestinal Microbial Profiles in Newly Diagnosed Crohn's Disease Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2021-02-03 date: 2024-08-31 date: 2024-12-31 date: 2024-03-22 date: 2024-03-22 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Crohn's disease (CD), a chronic inflammatory disease affecting the intestine, is characterised by a relapsing course. In 25% of cases, the onset of this disease occurs in childhood. Relevant studies have provided evidence of a key role of gut microbial communities (the microbiota) in triggering or maintaining active gut inflammation, pointing to gut dysbiosis as the main event disrupting the balance of microbial communities Recent evidence suggests that, in addition to the bacterial component, the commensal fungal component also plays a crucial role in CD.

The purpose of this prospective, longitudinal, study is to characterise the composition of intestinal bacterial and fungal communities in patients 6-18 years newly diagnosed with Crohn Disease in order to identify a possible association of specific faecal microbial profiles with a severe or mild-to-moderate disease course. conditions: Crohn Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ACTUAL name: Collection biological sample and analysis measure: Modifications in alpha and beta diversity of stool microbiome profile in patients with different phases of disease course (at diagnosis, remission and after one year of mantainance therapy) measure: Differences intestinal alpha and beta diversity, microbiome richness and composition between patients at high risk and patients at low risk measure: Indentification of different patterns of intestinal microbiome as a potential biomarker for high and low risk stratification sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Medical University of Graz-Educational center for Paediatric Gastroenterology, Hepatology and Nutrition, Department of Paediatrics and adolescence medicine city: Graz country: Austria lat: 47.06667 lon: 15.45 facility: Ospedale Maggiore-Azienda Usl Di Bologna city: Bologna country: Italy lat: 44.49381 lon: 11.33875 facility: Meyer Children's Hospital IRCCS city: Florence country: Italy lat: 43.77925 lon: 11.24626 hasResults: False

 nctId: NCT06324578 id: RC 25/2023 briefTitle: Prevalence of Pre-clinical Sjögren Disease and Other Immune Disturbances in Subjects With Autoimmune Thyroiditis Disease overallStatus: RECRUITING date: 2023-09-25 date: 2025-12-31 date: 2025-12-31 date: 2024-03-22 date: 2024-03-22 name: IRCCS Burlo Garofolo class: OTHER briefSummary: The main study hypothesis is that Sjögren Disease (SD), usually considered a disorder typical of adult females, may occur not exceptionally in adolescence or even in childhood as a subclinical process. There are several pieces of evidence in favor of this hypothesis, from the incidental detection of asymptomatic SD in pediatric age to biobank-based studies showing that biological signs of SD may precede the disease clinical onset by years or decades. The best scenario to verify this hypothesis could be that of autoimmune thyroiditis, for the following three reasons: 1) subjects with Autoimmune thyroiditis (AT) have a high risk of developing SD (7%); 2) in cases with comorbidity of SD and AT the diagnosis of AT had usually been made before; 3) subjects with AT routinely undergo periodic blood examination and neck ultrasonography (US), which may include Salivary Gland Ultrasound (SGUS) providing contributive data to detect an asymptomatic pre-SD. The knowledge of the real association between AT and pre-SD may impact on several aspects of medicine. conditions: Sjögren conditions: Autoimmune Thyroid Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 150 type: ESTIMATED name: AT Testing measure: Prevalence of pre-SD in pediatric subjects with AT measure: Prevalence of pre-SD in pediatric subjects with AT measure: Prevalence of pre-SD in pediatric subjects with AT sex: ALL minimumAge: 0 Years maximumAge: 17 Years stdAges: CHILD facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" status: RECRUITING city: Trieste zip: 34137 country: Italy name: Alberto Tommasini, MD PhD Prof role: CONTACT phone: +39.040.785.422 email: alberto.tommasini@burlo.trieste.it name: Barbara Bonifacio role: CONTACT phone: +39.040.3785.422 email: barbara.bonifacio@burlo.trieste.it lat: 45.64953 lon: 13.77679 hasResults: False

 nctId: NCT06324565 id: RC 24/2021 briefTitle: Role of Preoperative D-dimer Levels in the Diagnosis of Adnexal Torsion overallStatus: RECRUITING date: 2022-01-13 date: 2024-12-13 date: 2024-12-13 date: 2024-03-22 date: 2024-03-22 name: IRCCS Burlo Garofolo class: OTHER briefSummary: Adnexal torsion is the fifth most common gynecologic emergency. Thirty percent of all cases of adnexal torsion occur in females younger than 20 years. Approximately 5 of 100,000 females aged 1-20 years are affected, with girls older than 10 years at increased risk because of hormonal influences and gonadal growth that result in an increased frequency of physiologic and pathologic masses. The most common clinical symptom of torsion is sudden-onset abdominal pain that is intermittent, non-radiating, and associated with nausea and vomiting in 62% and 67% of cases respectively. Moreover, abdominal tenderness is a clinical sign which is reported in up to 88% of patients with adnexal torsion. None of the following tests are useful in the diagnosis of adnexal torsion: leukocytosis, pyuria, C-reactive protein, and erythrocyte sedimentation rate. Actually, transabdominal ultrasonography is the imaging modality of choice with a sensitivity of 92% and specificity of 96% in detecting adnexal torsion. A second-line imaging tool in the diagnosis of adnexal torsion is magnetic resonance, which may require a sedation in selected cases. Consequently, there are no clinical or imaging criteria sufficient to confirm the preoperative diagnosis of adnexal torsion to date. Therefore, patients with a clinical suspicion for adnexal torsion should undergo emergent diagnostic laparoscopy. conditions: Adnexal Torsion studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 130 type: ESTIMATED name: D-Dimer test measure: Diagnostic accuracy of the D-Dimer sex: FEMALE maximumAge: 17 Years stdAges: CHILD facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" status: RECRUITING city: Trieste zip: 34137 country: Italy name: Alessandro Boscarelli, MD role: CONTACT phone: +393931757607 email: alessandro.boscarelli@burlo.trieste.it lat: 45.64953 lon: 13.77679 hasResults: False

 nctId: NCT06324552 id: RC 16/18 briefTitle: Defects of Keratinocytes Function in Dermatologic Patients overallStatus: RECRUITING date: 2020-10-12 date: 2023-06-03 date: 2024-05-31 date: 2024-03-22 date: 2024-03-22 name: IRCCS Burlo Garofolo class: OTHER briefSummary: NOTCH signaling in the skin exerts a pivotal role in the regulation of normal keratinocytes turnover by mediating the balance between proliferation, differentiation, apoptosis and autophagic flux progression. Two skin diseases are characterized by the presence of gene variants that cause an impairment in NOTCH signaling: hidradenitis suppurativa(HS) and Dowling-Degos disease(DDD). To date, both HS and DDD are orphan diseases still lacking of specific treatments. This project aims at improving the current knowledge on the pathogenesis of HS and DDD, by deepening the understandings on the role played by keratinocytes in these pathologies and also by determining why mutations found in the same pathway cause different diseases. This study aimed to obtain in vitro models, derived directly from patients (from hair follicles) and from keratinocytes (HaCaT) cell cultures, for the study of these skin pathologies and also for the testing of novel innovative therapies such as photobiomodulation therapy. conditions: Hidradenitis Suppurativa studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Evaluation of the impact of candidate variants in hair follicles epithelial cell biology by generating Knock-Out (KO) keratinocyte cell lines (HaCaT) measure: Evaluation of the impact of photobiomodulation (PBM) therapy in hair follicles epithelial cells derived from patients and in HaCaT KO cells, sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" status: RECRUITING city: Trieste zip: 34137 country: Italy name: Paola Maura Tricarico, BSc role: CONTACT phone: +39 0403785111 email: paolamaura.tricarico@burlo.trieste.it lat: 45.64953 lon: 13.77679 hasResults: False

 nctId: NCT06324539 id: PNRR-POC-2022-12376280 briefTitle: Validation of a New Innovative Method for Specific Marker Detection in Celiac Disease overallStatus: RECRUITING date: 2023-10-04 date: 2025-05 date: 2025-05 date: 2024-03-22 date: 2024-03-22 name: IRCCS Burlo Garofolo class: OTHER briefSummary: Celiac disease (CD) is a common auto-immune disorder induced by gluten ingestion in genetically susceptible individuals (HLA-DQ2/DQ8). Gluten induces small-bowel villous atrophy and a specific immune response characterized by the production of CD-autoantibodies against transglutaminase 2 (anti-TG2) and endomysium (EMA). In symptomatic patients with positive-serum antibodies and villous atrophy, the diagnosis of CD is clearcut.

However, 10-30% of patients evaluated for suspected CD show only mild histopathologic changes and fluctuating serologic markers, a condition identified as potential CD. In such cases the diagnosis may remain uncertain.

CD-autoantibodies are produced by intestinal B-cells in the early phases of the disease, before their appearance in the serum and when the duodenal mucosa is still normal. Intestinal CD-antibodies (I-CD-abs) are a marker of CD, have a high sensitivity and specificity for CD and identify those patients with potential CD who are at risk of progression to villous atrophy. I-CD-abs can be detected by double immunofluorescence staining on frozen duodenal sections or by using an endomysial antibody assay in the culture medium of duodenal biopsies (EMAbiopsy).

The diagnostic accuracy of these techniques is comparable as they both have high sensitivity and specificity. However, their implementation in clinical practice is limited because they require both experienced operators and well-equipped laboratories. There is an unmet need: the development of a new simple and effective diagnostic tool that any gastroenterology unit can use in routine diagnostics to ensure a prompt diagnosis in suspected CD patients, who may benefit from a therapy based on gluten-free diet, and to reduce both unnecessary medical investigations and diagnostic delays.

In order to simplify and shorten times for the detection of these intestinal antibodies, the study aims to substitute the EMAbiopsy assay with a supernatant obtained quickly after mechanical lysis of fresh intestinal biopsy specimen. The obtained samples will be tested with rapid (about 15 minutes) immune-chromatographic anti-TG2 assay (Rapid Intestinal anti-TG2 Assay). conditions: Celiac Disease in Children studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 332 type: ESTIMATED name: Diagnostic Test: Rapid Intestinal anti-TG2 Assay name: Diagnostic Test: Rapid Intestinal anti-TG2 Assay measure: Sensitivity of the EMA-biopsy in comparison to the reference standard (serology + histology) for CD diagnosis measure: Specificity of the EMA-biopsy in comparison to the reference standard (serology + histology) for CD diagnosis measure: Sensitivity of the Rapid Intestinal anti-TG2 Assay in comparison to the reference standard (serology + histology) for CD diagnosis measure: Specificity of the Rapid Intestinal anti-TG2 Assay in comparison to the reference standard (serology + histology) for CD diagnosis sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" status: RECRUITING city: Trieste zip: 34137 country: Italy name: Luigina De Leo role: CONTACT phone: +39.040.3785.472 email: luigina.deleo@burlo.trieste.it lat: 45.64953 lon: 13.77679 hasResults: False

 nctId: NCT06324526 id: 070324QL briefTitle: Obesity and Health-related Quality of Life in Patients Receiving Bariatric Surgery in the UK overallStatus: COMPLETED date: 2017-06-01 date: 2022-11-23 date: 2022-11-23 date: 2024-03-22 date: 2024-03-25 name: Imperial College London class: OTHER name: University of Oxford briefSummary: United Kingdom National Bariatric Surgery Registry (NBSR) records between 1st June 2017 and 23rd November 2022 were used to identify people undergoing primary bariatric (weight-loss) surgery. People undergoing primary bariatric (weight-loss) surgery with one baseline and at least one follow-up visit within one year from surgery were included. Statistical models were used to estimate the relationship between quality of life as assessed by a questionnaire and body mass index at baseline and over time. conditions: Quality of Life conditions: Obesity, Morbid conditions: Bariatric Surgery Candidate studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2160 type: ACTUAL measure: EQ-5D (EuroQol Five Dimension) measure: BMI sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Surgery and Cancer, Imperial College London city: London zip: W2 1NY country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06324513 id: Med-CDED briefTitle: Evaluation of the Efficacy and Tolerability of the Mediterranean Diet Pattern in the Exclusion Diet for Patients With Crohn's Disease. overallStatus: RECRUITING date: 2023-07-27 date: 2025-07-27 date: 2025-10-27 date: 2024-03-22 date: 2024-03-22 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: The proposed study aims to assess the efficacy and tolerability of adapting the CDED to the Mediterranean diet pattern, without compromising its key principles, namely the exclusion of ultra-processed foods with potential pro-inflammatory effects on the intestines. The decision to modify the CDED according to the characteristics of the Mediterranean diet pattern and to evaluate the potential of this modified version of the exclusion diet for Crohn's disease in terms of efficacy and tolerability are the main objectives of this study.

These objectives are driven not only by scientific evidence regarding the anti-inflammatory potential and protective role against chronic-degenerative diseases demonstrated by the Mediterranean diet but also to allow for greater adherence to Italian dietary traditions and improve compliance with the dietary regimen.

Furthermore, to date, there are no comprehensive multi-omic investigations integrating dietary data with microbiome, metabolome, and transcriptome profiles that can demonstrate the effect of the CDED at "omic" levels. A very recent study on pediatric patients shows interesting results regarding differential profiles of fecal metabolites after administration of CDE or NEE in different weeks of therapy. conditions: Crohn Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 120 type: ESTIMATED name: Mediterranean Crohn's Disease Exclusion Diet (Med-CDED) name: Crohn's disease exclusion diet (CDED) measure: Clinical response to the first phase of diet measure: Clinical remission rate measure: Adherence rate to the Med-CDED diet and comparison to the original CDED both in pediatric and adult cohort measure: Clinical remission rate in adult patients at the end of phase I of diet measure: Transmural response of the thickness of the intestinal loops both in pediatric and adult cohort measure: Assessment of the reduction or normalization of inflammation markers both in pediatric and adult cohort measure: Assessment of clinical remission rate at the end of Phase II of the Med-CDED diet and comparision with the original CDED both in pediatric and adult cohort measure: Assessment of clinical remission rate at the end of Phase III of the Med-CDED diet and comparision with the original CDED both in pediatric and adult cohort measure: Endoscopic response rate obtained at 6 months both in pediatric and adult cohort measure: Assessment of the modification of the intestinal microbiota composition (trough alpha and beta diversity) at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort measure: Assessment of the metabolome profiles at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort measure: Assessment of the trascriptome profiles at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort measure: Ability to maintain a healthy and balanced diet and patient satisfaction with the treatment both in pediatric and adult cohortreceived sex: ALL minimumAge: 4 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Firenze country: Italy name: Paolo Lionetti role: CONTACT email: paolo.lionetti@meyer.it lat: 43.77925 lon: 11.24626 facility: Ospedali Riuniti Villa Sofia-Cervello status: RECRUITING city: Palermo country: Italy name: Ambrogio Orlando role: CONTACT email: ambrogiorlando@gmail.com lat: 38.13205 lon: 13.33561 facility: Università La Sapienza di Roma status: RECRUITING city: Roma country: Italy name: Salvatore Oliva role: CONTACT email: salvatore.oliva@uniroma1.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06324500 id: ASC-US briefTitle: Prognostic Role of Bowel Ultrasound Scan in Children Affected by Acute Severe Colitis overallStatus: RECRUITING date: 2020-03-02 date: 2025-03-02 date: 2025-05-02 date: 2024-03-22 date: 2024-03-22 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: ASC is a life-threatening medical emergency. The lack of a timely intervention has shown to be associated with a mortality rate higher than 20% in adults, whereas a prompt targeted therapy has displayed a decrease of the aforementioned rate to 1%. Therefore, the identification of predictors of poor outcome trough an objective tool may provide crucial help to individualize the timing of second line treatment initiation. At the state of the art, PUCAI represents the only validated tool to appraise the risk of first-line treatment failure and there is a lack of objective methods with a prognostic value in ASC.

BUS has proven to be a reliable tool in assessing disease activity in children with UC and it has also shown statistically significant correlation with endoscopic features of disease activity. Given the literature suggesting a role for BUS in severe UC and the results from our retrospective study we aim to validate our findings trough a prospective assessment of the potential prognostic role of BUS in ASC. conditions: Acute Severe Colitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: Colonic wall thickness of BUS (bowel ultrasound) parameter to predict the failure of first line treatment measure: Color and power Doppler vascularization of BUS (bowel ultrasound) parameter to predict the failure of first line treatment measure: Mesenteric lymph nodes BUS (bowel ultrasound) parameter measure: evaluation of the prognostic value of the ultrasound parameters sex: ALL minimumAge: 1 Year maximumAge: 17 Years stdAges: CHILD facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence state: Firenze zip: 50139 country: Italy name: Paolo Lionetti role: CONTACT email: paolo.lionetti@meyer.it lat: 43.77925 lon: 11.24626 facility: Ospedale Maggiore status: RECRUITING city: Bologna country: Italy name: Patrizia Alvisi role: CONTACT email: Patrizia.alvisi@ausl.bologna.it lat: 44.49381 lon: 11.33875 facility: IRCCS Materno Infantile Burlo Garofolo status: RECRUITING city: Trieste country: Italy name: Matteo Bramuzzo role: CONTACT email: matteo.bramuzzo@burlo.trieste.it lat: 45.64953 lon: 13.77679 facility: CMED Centro Médico-Quirúrgico de Enfermedades Digestivas status: RECRUITING city: Madrid country: Spain name: Marta Velasco Rodriguez- Belvis role: CONTACT email: martavrb@gmail.com lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06324487 id: E-10840098-772.02-7487 briefTitle: A New Application in Subacromial Impingement Syndrome overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-01 date: 2024-04-01 date: 2024-06-01 date: 2024-03-22 date: 2024-03-22 name: Medipol University class: OTHER briefSummary: Individuals diagnosed with Subacromial Impingement Syndrome by a physical therapist based on MRI results and examination findings will be included in the study. 40 people will be randomly divided into blood flow restrictive exercise (BFRT) and structured exercise program (SEP) groups, 20 people in each group. Participants will receive two evaluations: before starting treatment and immediately after 4 weeks of treatment. Pain, shoulder ROM, shoulder functional level, quality of life, shoulder muscle strength, grip strength, and sleep quality evaluation will be performed. The treatment program will be 5 days a week for a total of 4 weeks. The treatment will be individualized by calculating the appropriate resistance loads for the exercise program. All participants will undergo progressive exercises in sessions conducted by a physiotherapist. conditions: Subacromial Impingement Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Progressive Exercises name: Blood Flow Restriction Therapy measure: Pain İntensity measure: Shoulder ROM measure: Quality of Life Assessment measure: Sleep Quality Assessment measure: Shoulder Functional Level Assessment measure: Shoulder Muscle Strength Assessment measure: Grip Strength Assessment sex: ALL minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medipol University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06324474 id: HA treatment of periodontitis briefTitle: Clinical and Immunological Evaluation of HA in Treatment of Periodontitis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12-12 date: 2024-12-12 date: 2024-03-22 date: 2024-03-22 name: Sana'a University class: OTHER briefSummary: To evaluate the immunological effectiveness of Hyaluronic acid as adjunction treatment to scaling and root planning and scaling and root planning alone.

Comparison between clinical measurement before and after treatment. Evaluate the level of IGF-1 in treated site as immunological marker if periodontal regeneration. conditions: Periodontitis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Hyaluronic acid name: scaling and root planning measure: Changes in Plaque Index measure: Changes in Gingival Index measure: Changes in Papillary Bleeding Index. measure: Periodontal Probing Depth measure: Clinical attachment loss measure: Changes in IGF-1 sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Sana'a university city: Sana'a country: Yemen lat: 15.35472 lon: 44.20667 hasResults: False

 nctId: NCT06324461 id: GLUMINS briefTitle: GLP-1 Receptor Agonist for Reduction of Myocardial Injury After Non-cardiac Surgery acronym: GLUMINS overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2026-12-31 date: 2027-12-31 date: 2024-03-22 date: 2024-03-22 name: The University of Hong Kong class: OTHER briefSummary: This is an investigator initiated, multi-center, open-labelled, superiority randomized controlled trial of 372 patients undergoing elective non-cardiac surgery. Recruited patients will be randomized in a 2:1 ratio to receive single subcutaneous dose of Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RAs) 1 to 4 days prior to surgery or receive routine care.

Semaglutide (Ozempic; Novo Nordisk, Denmark) is chosen as GLP-1 Receptor Agonists investigational drug for this study. Apart from peri-operative routine care, all recruited subjects will undergo physical, respiratory and cardiac assessments including electrocardiography and blood check including cardiac enzymes. Myocardial injury, cardiovascular outcomes and safety will be assessed and evaluated for efficacy and safety of this prophylactic measurement for the reduction of myocardial injury after non-cardiac surgery. conditions: Myocardial Injury studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Open-labelled, superiority randomized controlled trial primaryPurpose: PREVENTION masking: NONE count: 372 type: ESTIMATED name: Semaglutide 0.25mg subcutaneous injection measure: Proportion of patients with MINS measure: Proportion of patients with composite of non-fatal MINS, non-fatal stroke or cardiovascular mortality measure: Proportion of patients with MINS who do not fulfill the 4th universal definition of myocardial infarction measure: Proportion of patients with myocardial infarction according to the 4th universal definition of myocardial infarction measure: Proportion of patients with ischemic stroke measure: Proportion of patients with cardiovascular death measure: Proportion of patients with all-cause mortality measure: Mean days alive and out of hospital measure: Clinically important atrial fibrillation measure: Clinically significant hypoglycaemia measure: Mean peak troponin T concentration measure: Mean area under curve of troponin T concentration measure: Proportion of patients with coronary revascularization measure: Proportion of patients who require readmission for cardiovascular conditions measure: Proportion of patients with non-fatal cardiac arrest measure: Proportion of patients who require hospitalization for heart failure measure: Proportion of patients who develop pulmonary embolism and/or deep vein thrombosis measure: Proportion of patients with International Society on Thrombosis and Haemostasis (ISTH) major bleeding measure: Proportion of patients with bleeding independently associated with mortality following noncardiac surgery (BIMS) measure: Proportion of patients with infection or sepsis measure: Proportion of patients with acute renal failure fulfilling Kidney Disease Improving Global Outcomes (KDIGO) criteria measure: Proportion of patients with acute renal failure requiring dialysis measure: Proportion of patients requiring amputation measure: Mean length of stay measure: Mean length of intensive care unit stay measure: Mean days alive without need for intensive care support sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Queen Mary Hospital city: Hong Kong state: Hong Kong SAR country: China lat: 22.39407 lon: 114.13737 hasResults: False

 nctId: NCT06324448 id: PD-tDCS-RCT briefTitle: Self-administered tDCS for Improving Single- and Dual-task Gait in Patients With PD overallStatus: RECRUITING date: 2024-02-15 date: 2025-02-01 date: 2025-02-28 date: 2024-03-22 date: 2024-03-26 name: Seoul National University Hospital class: OTHER briefSummary: The purpose of this study is to investigate the efficacy and safety of self-administered transcranial direct current stimulation to improve the single- and dual-task gait in patients with Parkinson's disease. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized controlled trial primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Transcranial direct current stimulation measure: Timed-up and go test (sec) measure: Timed-up and go test under dual-task condition (sec) measure: Dual-task effect (%) in Timed-up and go test measure: modified Attention Allocation Index (mAAI) in Timed-up and go test measure: Gait parameters measure: Single-leg stance test measure: Stroop test measure: Trail making test measure: New freezing of gait questionnaire (NFoGQ) measure: Geriatric depression scale (GDS)-short form measure: Timed-up and go test (sec) measure: Timed-up and go test under dual-task condition (sec) measure: Dual-task effect (%) in Timed-up and go test measure: modified Attention Allocation Index (mAAI) in Timed-up and go test measure: Gait parameters measure: Single-leg stance test measure: Stroop test measure: Trail making test measure: New freezing of gait questionnaire (NFoGQ) measure: Geriatric depression scale (GDS)-short form sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital status: RECRUITING city: Seoul zip: 03080 country: Korea, Republic of name: Han Gil Seo, MD role: CONTACT phone: 82-2-2072-1659 email: hgseo80@gmail.com lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06324435 id: 2000037439 id: U54AA027989 type: NIH link: https://reporter.nih.gov/quickSearch/U54AA027989 briefTitle: Apremilast for Alcohol Use Disorder Treatment in Women and Men overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-02-28 date: 2025-02-28 date: 2024-03-22 date: 2024-03-22 name: Yale University class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) name: Office of Research on Women's Health (ORWH) briefSummary: For this protocol, the investigators plan to collect pilot data to evaluate apremilast (60mg/day) in adults with Alcohol Use Disorders (AUD). conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 10 type: ESTIMATED name: Apremilast measure: Alcohol Consumption sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06324422 id: Fatigue & Parkinson's disease briefTitle: Exercise as Treatment of Fatigue in Parkinson´s Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-01 date: 2026-12-01 date: 2024-03-22 date: 2024-03-22 name: University of Aarhus class: OTHER briefSummary: The primary goal of this study is to test whether 12 weeks of high-intensity aerobic exercise can treat fatigue in Parkinsons disease (PD).

The study will be a randomized multi-site controlled trial with follow up. Clinically fatigued persons with PD will be allocated to either 12 weeks of high-intensity aerobic exercise or to a waitlist control group receiving high-intensity resistance exercise after 24 weeks of habitual lifestyle (control period).

It is hypothesized that persons with PD receiving 12 weeks of high-intensity aerobic exercise will show superior effects on perceived fatigue (i.e., clinical relevant reductions) when compared to the PD control group (primary hypothesis), and that these effects are sustained after 12-weeks of follow up (secondary hypothesis). conditions: Parkinson's Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled multi-site trial with follow-up primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 94 type: ESTIMATED name: Aerobic exercise intervention name: Resistance exercise intervention measure: Change in Modified Fatigue Impact Scale measure: Change in Fatigue Severity Scale measure: Change in Parkinson's Fatigue Scale measure: Change in Parkinson's Disease Questionnaire 39 measure: Change in Baecke Habitual Physical Activity Questionnaire measure: Change in Pitchburg Sleep Quality Index measure: Change in Major Depression Inventory measure: Change in European Quality of life - 5 Dimensions measure: Change in Non-motor Symptoms Questionnaire measure: Change in Brief Pain Inventory (Short Form) measure: Change in The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale measure: Change in Six Minute Walk Test measure: Change in Timed Up and Go measure: Change in Six Spot Step Test measure: Change in Symbol Digit Modalities Test measure: Change in Montreal Cognitive Assessment measure: Change in Muscle strength measure: Change in aerobic capacity measure: Change in Physical activity measure: Change in Rochester Fatigue Diary measure: Change in Visual Analog Scale for fatigue, tremor, bradykinesia, rigidity and postural instability sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Exercise Biology, Dep. of Public Health, Aarhus University city: Aarhus state: Midtjylland zip: 8000 country: Denmark name: Cecilie Thrue, PhD student role: CONTACT phone: 004520768102 email: ceth@ph.au.dk name: Cecilie Thrue, PhD student role: PRINCIPAL_INVESTIGATOR lat: 56.15674 lon: 10.21076 hasResults: False

 nctId: NCT06324409 id: H-350 briefTitle: ImmigrantScreen Telephone Reminder Trial in Colorectal Cancer Screening overallStatus: NOT_YET_RECRUITING date: 2024-03-22 date: 2024-12-31 date: 2025-03-30 date: 2024-03-22 date: 2024-03-25 name: Norwegian Institute of Public Health class: OTHER_GOV briefSummary: The goal of this randomized trial is to test the effect of a reminder telephone call in the official native language in the country where the invitee is born, in addition to the reminder letter in Norwegian on participation in the National Colorectal Cancer Screening Program in Pakistani and Somalian immigrants, compared to the reminder letter in Norwegian only.

The main question it aims to answer is:

•Does a reminder telephone call in the language of origin increase participation in colorectal cancer screening in Pakistani and Somalian immigrants in Norway?

Participants in this trial are individuals with Pakistan or Somalia as their country of birth invited to the National Colorectal Cancer Screening Program, who have not participated by mailing a faecal sample to the screening laboratory.

In the intervention group, the participants will be called in the official language in their country of origin, to inform about colorectal cancer screening, in addition to the reminder letter in Norwegian language sent to all non-participants.

Participants in the comparison group will only be sent the reminder letter in Norwegian language.

The researchers will compare differences in the participation rate in the National Colorectal Cancer Screening Program between the intervention and comparison groups. conditions: Cancer Colorectal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There is an intervention group and a comparison group in the study. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 600 type: ESTIMATED name: Reminder telephone call measure: First round screening participation measure: Overall screening participation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06324396 id: STUDY00002974 briefTitle: IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease acronym: IMPROVE-FALD overallStatus: RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-22 date: 2024-03-22 name: Children's Mercy Hospital Kansas City class: OTHER name: Indiana Clinical and Translational Sciences Institute briefSummary: This is a single center, open-label, prospective, investigation to quantify the effects liver congestion and fibrosis has on hepatic drug metabolism and transport in children, adolescents, and young adults with Fontan circulation. conditions: Fontan Circulation studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a single center, open-label, prospective, investigation to quantify the effects of liver congestion and fibrosis has on hepatic statin transport (SA1) and response (SA2) in children, adolescents, and young adults with Fontan circulation. primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg) name: Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years) measure: Sildenafil concentration as measured by area under the curve (AUC) measure: Pravastatin concentration as measured by area under the curve (AUC) sex: ALL minimumAge: 8 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Children's Mercy Hospital status: RECRUITING city: Kansas City state: Missouri zip: 64108 country: United States name: Jonathan Wagner, DO role: CONTACT name: Jonathan Wagner, DO role: PRINCIPAL_INVESTIGATOR lat: 39.09973 lon: -94.57857 hasResults: False

 nctId: NCT06324383 id: 1782599 briefTitle: Enhancing Purpose and Well-Being Through a Volunteering Experience Connecting Veterans With English Language Learners overallStatus: NOT_YET_RECRUITING date: 2024-03-28 date: 2025-03-28 date: 2025-03-28 date: 2024-03-22 date: 2024-03-22 name: University of Michigan class: OTHER briefSummary: The goal of this study is to refine and test a strategy for engaging Veterans with symptoms of depression, anxiety, and/or PTSD as volunteers to help English language learners (ELLs) improve their speaking skills via structured conversations using videoconferencing. conditions: Depression, Anxiety, PTSD studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 80 type: ESTIMATED name: Intervention (videoconferencing) measure: France and Finney "Mattering" measure: (Patient Health Questionnaire) PHQ-8 measure: (Generalized Anxiety Disorder) GAD-7 measure: (Posttraumatic Stress Disorder Checklist) PCL-5 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Clinical Management Research (CCMR), North Campus Research Complex city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-28 uploadDate: 2024-03-12T11:49 filename: ICF_000.pdf size: 166776 hasResults: False

 nctId: NCT06324370 id: FIERC-2022-023 briefTitle: Exploratory Pharmacokinetic Study of Virgin Coconut Oil (VCO) overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-13 date: 2024-06-30 date: 2024-06-30 date: 2024-03-22 date: 2024-03-22 name: Food and Nutrition Research Institute, Philippines class: OTHER_GOV name: Ateneo de Manila University name: De La Salle Medical and Health Sciences Institute briefSummary: This is a balanced, open-label, single- and multiple-dose pharmacokinetic (PK) study of virgin coconut oil (VCO) among healthy Filipino male adults 18-45 years of age in Dasmariñas, Cavite. This study aims to determine the rate and extent of absorption of virgin coconut oil (VCO) administered in healthy male human study participants under fed conditions in single and multiple doses and to monitor the safety and tolerability of virgin coconut oil (VCO) following the standard protocol developed by the De La Salle Medical and Health Sciences Institute (DLSMHSI). conditions: Pharmacological Action studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: This will be a two-sequence (single- and multiple-dose) pharmacokinetic study in healthy Filipino male human participants under fed conditions. primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: This will be an open-label pharmacokinetic study in healthy Filipino male human participants under fed conditions. count: 16 type: ACTUAL name: Virgin Coconut Oil measure: Pharmacokinetics (AUC0-t) measure: Pharmacokinetics (Cmax) measure: Pharmacokinetics (AUC0-inf) measure: Pharmacokinetics (tmax) measure: Pharmacokinetics (Kel) measure: Pharmacokinetics (t1/2) measure: Vital Signs (Systolic and Diastolic Blood Pressure) measure: Vital Signs (Pulse rate) measure: Vital Signs (Body temperature) measure: Vital Signs (Respiratory rate) measure: Safety and Tolerability (Adverse events) measure: Post Study Evaluation (Fasting Blood Sugar Test) measure: Post Study Evaluation (Blood Urea Nitrogen Test) measure: Post Study Evaluation (Creatinine) measure: Post Study Evaluation (Uric Acid) measure: Post Study Evaluation (Serum Glutamic Pyruvic Transaminase Test) measure: Post Study Evaluation (Serum Glutamic-oxaloacetic Transaminase Test) measure: Post Study Evaluation (Alkaline Phosphatase Test) measure: Post Study Evaluation (TPAG- Total Protein, Albumin, Globulin Ratio Test) measure: Post Study Evaluation (Indirect, Direct and Total Bilirubin) measure: Post Study Evaluation (Lipid Profile - High-density lipoprotein, Low-density lipoprotein, Cholesterol and Triglycerides) measure: Post Study Evaluation (Lipase Test) measure: Post Study Evaluation (Amylase Test) measure: Post Study Evaluation (Complete Blood Count with Platelet Count Test) measure: Post Study Evaluation (Complete Urinalysis) measure: Post Study Evaluation (Fecalysis) sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI) city: Taguig state: Metro Manila zip: 1630 country: Philippines lat: 14.52429 lon: 121.07921 hasResults: False

 nctId: NCT06324357 id: 1479-0012 briefTitle: Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib in Combination With Trastuzumab Deruxtecan or With Trastuzumab Emtansine and to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2027-02-22 date: 2028-08-21 date: 2024-03-21 date: 2024-04-24 name: Boehringer Ingelheim class: INDUSTRY briefSummary: This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful. The purpose of this study is to find a suitable dose of zongertinib that people with different types of HER2+ cancer that has spread can tolerate best when taken together with trastuzumab deruxtecan (T-DXd) or with trastuzumab emtansine (T-DM1). Another purpose is to check whether zongertinib in combination with T-DXd or with T-DM1 can make tumours shrink. Zongertinib inhibits HER2. HER2 causes cancer cells to grow.

The study is split into treatment cycles. All study participants are treated with zongertinib in combination with T-DXd or with T-DM1. This study has 2 parts. In Part 1, participants receive increasing doses of zongertinib. In Part 2, participants are put into different groups by chance. Each group receives a different dose of zongertinib. Every participant has an equal chance of being in each group.

During the study, the participants visit the study site regularly. In this study, researchers want to find the highest dose of zongertinib that participants can tolerate when taken together with T-DXd or with T-DM1. To find this out, researchers look at certain severe health problems that a number of participants have. The doctors regularly check the size of the tumour with imaging methods (CT/MRI) during the study. The doctors also regularly check participants' health and take note of any unwanted effects. conditions: Metastatic Breast Cancer conditions: Metastatic Gastric Adenocarcinoma conditions: Gastroesophageal Junction Adenocarcinoma conditions: Esophageal Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 240 type: ESTIMATED name: Zongertinib name: Trastuzumab deruxtecan name: Trastuzumab emtansine measure: Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period measure: Dose optimization (Phase II): Objective response (OR) measure: Dose escalation (Phase Ib): Objective response (OR) measure: Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) during the entire treatment period measure: Dose escalation (Phase Ib): Maximum measured concentration of the analyte in plasma (Cmax) measure: Dose escalation (Phase Ib): Area under the concentration-time curve of the analyte in plasma from 0 to t2 (AUC0-t2) measure: Dose optimization (Phase II): Progression-free survival (PFS) measure: Dose optimization (Phase II): Disease control (DC) measure: Dose optimization (Phase II): Occurrence of treatment-emergent AEs leading to zongertinib (BI 1810631) dose reduction during the on-treatment period measure: Dose optimization (Phase II): Maximum measured concentration of the analyte in plasma (Cmax) measure: Dose escalation (Phase II): Area under the concentration-time curve of the analyte in plasma from 0 to t2 (AUC0-t2) measure: Dose optimization (Phase II): Patient-reported outcome (PRO) - PRO-CTCAE measure: Dose optimization (Phase II): Patient-reported outcome (PRO) - EORTC IL46 measure: Dose optimization (Phase II): Patient-reported outcome (PRO) - EORTC IL19 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06324344 id: H-50753-B briefTitle: Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN) overallStatus: RECRUITING date: 2023-10-02 date: 2025-10-02 date: 2025-10-02 date: 2024-03-21 date: 2024-03-25 name: Baylor College of Medicine class: OTHER name: NeuroMetrix, Inc. briefSummary: The purpose of this pilot study is to examine the acceptability and proof of concept effectiveness of a wireless Transcutaneous Electrical Nerve Stimulation (TENS) technology to address Chemotherapy Induced Peripheral Neuropathy (CIPN). Participants, who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned with ratio of 1:1 into two groups. The patients and clinicians will be blinded for group allocation. One group will utilize TENS high-dose devices (Intervention group, IG); the other group will utilize low-dose TENS devices (Placebo group, PG). The baseline measurements will be performed, and the patients will take the programmed device home for a duration of 8 weeks. Then, the patients will come back after four weeks (4W) and after 8 weeks (8W) for outcome assessment. The primary outcome will be pain. Secondary outcomes include: nerve conduction and velocity, vibration perception threshold, quality of life. Exploratory outcomes include gait assessment (gait speed, stride length, double stance, and gait steadiness), and balance. conditions: Chemotherapy-induced Peripheral Neuropathy conditions: Pain conditions: Neuropathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned into two groups in a 1:1 ratio. One group will utilize high-dose TENS therapy (Intervention group, AG); the other group will utilize low-dose TENS devices (Placebo group, PG).

Both groups will receive their respective devices at the initial visit (Baseline) and will be asked to return in 4 weeks and 8 weeks for follow-up assessment.

Throughout this 8-week period the participants may receive follow-up phone calls assessing their compliance. All subjects will keep their active device after completion of the 8-week study. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Double whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 30 type: ESTIMATED name: High-Dose TENS name: Low-Dose TENS measure: Change in pain level at 8 weeks from baseline measure: Change in vibration perception threshold at 8 weeks from baseline measure: Change in sural nerve conduction velocity and amplitude at 8 weeks from baseline measure: Changes in Quality of Life at 8 weeks from baseline measure: Changes in stride time at 8 weeks from baseline measure: Changes in cadence at 8 weeks from baseline measure: Changes in double-support phase at 8 weeks from baseline measure: Changes in Range of Motion (RoM) at 8 weeks from baseline sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Baylor College of Medicine status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Bijan Najafi, PhD role: CONTACT phone: 713-798-7536 email: bijan.najafi@bcm.edu name: Maria Noun, BS role: CONTACT phone: 713-798-7538 email: maria.noun@bcm.edu lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06324331 id: Decidual sparing & CS niche briefTitle: Effect of Decidual Sparing in cs Niche Formation overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-09-01 date: 2025-12-01 date: 2024-03-21 date: 2024-03-21 name: Assiut University class: OTHER briefSummary: Assessing the impact of endometrial sparing at double-layer uterine closure as a specific surgical technique in CS to reduce the rate of post-cessarian delivery niche develoment conditions: Cesarean Section Complications conditions: Cesarean Section Niche studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SCREENING masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 184 type: ESTIMATED name: Decidual sparing name: Non decidual sparing measure: Impact of decidual sparing on niche formation measure: Impact of uterine closure technique on post CS niche criteria sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06324318 id: R01DA056417 type: NIH link: https://reporter.nih.gov/quickSearch/R01DA056417 id: R01DA056417 type: NIH link: https://reporter.nih.gov/quickSearch/R01DA056417 briefTitle: Parenting in 2 Worlds Multisite Trial acronym: (P2W) overallStatus: RECRUITING date: 2023-09-14 date: 2026-05-31 date: 2027-06-30 date: 2024-03-21 date: 2024-04-22 name: Arizona State University class: OTHER name: Phoenix Indian Center name: Ain Dah Yung Center name: Denver Indian Center Inc name: Native American Community Services of Erie and Niagara Counties name: National Institute on Drug Abuse (NIDA) briefSummary: This research study will test the effectiveness of a culturally grounded parenting intervention called Parenting in 2 Worlds (P2W). This intervention is designed for American Indian / Alaska Native (AI) parents/guardians of adolescents who reside in urban areas. This will be a multi-regional effectiveness trial across four regions: Northeast (Buffalo/Niagara), Midwest (St. Paul/Minneapolis), Mountain (Denver), and Southwest (Phoenix). There are four specific aims. First, this study will test the effectiveness of Parenting in Two Worlds (P2W) as compared to an informational family health intervention, Healthy Families in 2 Worlds (HF2W), in improving parenting and family functioning. Second, this study will test if the relative effectiveness of P2W, compared to HF2W, varies by parent's/guardian's level of socioeconomic vulnerability, experiences of historical loss, or AI cultural identity. Third, this study will examine if P2W can reduce adolescent (ages 12 - 17) risky health behaviors including substance use, depressive symptoms, suicidality, and risky sexual behaviors. Fourth, this study will examine whether positive changes in parenting and family functioning that result from P2W lead to positive changes in adolescent's health behaviors. conditions: Parenting conditions: Mental Health Wellness 1 conditions: Substance Use conditions: Risky Health Behavior studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 1440 type: ESTIMATED name: Parenting in 2 Worlds (P2W) name: Healthy Families in 2 Worlds (HF2W) measure: Change from baseline in family functioning and cohesion measure: Change from baseline in parental involvement measure: Change from baseline in parental supervision measure: Change from baseline in parental monitoring measure: Change from baseline in positive parenting practices measure: Change from baseline in relational warmth measure: Change from baseline in relational hostility measure: Change from baseline in family conflict measure: Change from baseline in parental self-agency measure: Change from baseline in effective discipline measure: Change from baseline in parental communication about sex measure: Change from baseline in child problem behaviors. measure: Change from baseline in decision making about risk behaviors measure: Change from baseline in substance use measure: Change from baseline in risky sexual behaviors measure: Change from baseline in depressive symptoms measure: Change from baseline in suicidality sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Phoenix Indian Center status: RECRUITING city: Phoenix state: Arizona zip: 85012 country: United States name: Jolyana Begay-Kroupa role: CONTACT phone: 602-264-6768 email: jbegay-kroupa@phxindcenter.org lat: 33.44838 lon: -112.07404 facility: Denver Indian Center status: RECRUITING city: Denver state: Colorado zip: 80219 country: United States name: Rick Waters role: CONTACT phone: 303-936-2688 email: rick@denverindiancenter.org lat: 39.73915 lon: -104.9847 facility: Ain Dah Yung Center status: RECRUITING city: Saint Paul state: Minnesota zip: 55104 country: United States name: Amy Arndt role: CONTACT phone: 651-227-4184 email: amy.arndt@adycenter.org lat: 44.94441 lon: -93.09327 facility: Native American Community Services Erie and Niagara Counties status: RECRUITING city: Buffalo state: New York zip: 14207 country: United States name: Michael Martin role: CONTACT phone: 716-299-0914 email: mmartin@nacswny.org lat: 42.88645 lon: -78.87837 hasResults: False

 nctId: NCT06324305 id: SRF drainage techniques in RRD briefTitle: Comparative Study Between Three Different Techniques in Drainage of SRF During PPV in RRD overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12 date: 2025-04 date: 2024-03-21 date: 2024-03-21 name: Ain Shams University class: OTHER briefSummary: The study will investigate and compare the three techniques in drainage of subretinal fluid in patients with macula off RRD: namely using the original break, performing a posterior drainage retinotomy and using PFC with drainage through the original break or peripheral retinotomy regarding the presence of persistent sub-retnal fluid and related intra or postoperative complications conditions: Rhegmatogenous Retinal Detachment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 66 type: ESTIMATED name: Pars plana vitrectomy (PPV) and drainage of subretinal fluid measure: The presence versus absence of sub-macular fluid using each of the three different techniques in pars plana vitrectomy (PPV) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06324292 id: FDASU-RecID112324 briefTitle: Effect Of Digital Smile Design on Quality Of Life In Complete Denture Wearers overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-09-01 date: 2024-09-15 date: 2024-03-21 date: 2024-03-26 name: Ain Shams University class: OTHER briefSummary: The aim of the current study protocol is to compare the effect of two complete dentures made for completely edentulous patients; one digitally constructed using digital smile design (DSD) and another one conventionally constructed on the patient's quality of life and patient's satisfaction.

It is a clinical trial in which two dentures will be made for each patient, one will be digitally constructed using digital smile design (DSD) and the other one using the conventional method with a washout period of 3 weeks. Each patient will receive a questionnaire "Oral Health Impact Profile -19" (OHIP -19) for the edentulous patients to evaluate his satisfaction with the denture. conditions: Complete Edentulism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The participants allocated into two groups; a conventional denture followed by a digital group (CG) and a digital denture followed by a conventional one group (DG). primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: complete denture, CG name: complete denture, DG measure: quality of life assessment sex: ALL minimumAge: 40 Years maximumAge: 55 Years stdAges: ADULT facility: Faculty of Dentistry Ain Shams University city: Cairo zip: 11361 country: Egypt lat: 30.06263 lon: 31.24967 facility: Faculty of Dentistry, Ain Shams University city: Cairo zip: 11361 country: Egypt name: ahmed MA mohamed, Bsc, Msc,MD role: CONTACT phone: 01111191337 phoneExt: 020 email: ahmedmostafa@dent.asu.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06324279 id: 000017585 briefTitle: Cervical Sliding Sign to Predict Outcome of Induction of Labor overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-01 date: 2024-04-01 date: 2024-04-01 date: 2024-03-21 date: 2024-03-21 name: Ain Shams Maternity Hospital class: OTHER briefSummary: Assess the role of transvaginal ultrasound specifically a sign called cervical sliding sign, in the prediction of success of induction of labor.

The prediction of outcome of induction of labor has always been an important topic to all obstetricians. Bishop score is traditionally considered reliable way to predict the outcome of induction of labor by assessing the cervical dilatation, effacement, position, and consistence and assessing the level of the fetal head in the birth canal. Since The bishop score remains a highly subjective method for prediction of outcome of induction of labor, the use of sonographic measurements such as cervical sliding sign can be a better predictor of successful induction of labor.The presence of CSS was defined as the sliding of the anterior cervical lip on the posterior one under gentle pressure of the transvaginal probe.

Patients undergoing induction of labor with misoprostol will be checked for the cervical sliding sign. The mode of delivery, induction to active labor time and active labor to delivery time will be recorded and analysed to assess whether the sliding sign is an independent predictor of success of induction. conditions: Induction of Labor conditions: Transvaginal Ultrasound: Cervical Sliding Sign studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 130 type: ACTUAL name: Transvaginal ultrasound name: Misoprostol 200mcg Tab measure: Mode of delivery measure: Induction to active labor time measure: Active labor to delivery time sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Maternity hospital, ainshams university hospitals city: Cairo zip: 11799 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06324266 id: 2023NZKY-044-02 briefTitle: Study on the Efficacy and Safety of Low-dose CTX as Maintenance Therapy for MM Unsuitable for Transplantation overallStatus: RECRUITING date: 2023-04-16 date: 2025-12-31 date: 2025-12-31 date: 2024-03-21 date: 2024-03-21 name: Jinling Hospital, China class: OTHER briefSummary: The investigators will conduct randomized and controlled clinical studies in order to preliminarily explore the efficacy and safety of low-dose cyclophosphamide and lenalidomide in maintenance therapy for MM that is not suitable for transplantation in the standard-risk group. conditions: Newly Diagnosed Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Cyclophosphamide name: Lenalidomide measure: PFS1 measure: Incidence of Efficacy as assessed by IMWG measure: Incidence of Safety as assessed by CTCAE 4.0 sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jinling Hospital status: RECRUITING city: Nanjing state: Jiangsu country: China name: Zhao Qian role: CONTACT phone: 18251835035 email: 540598707@qq.com lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06324253 id: 1/24 UROL2 briefTitle: Thoracic Epidural Analgesia With Bilateral Erector Spinae Plane Block in Radical Cystectomy Surgery acronym: TEAvsESB overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2024-05-10 date: 2024-06-10 date: 2024-03-21 date: 2024-03-21 name: Menoufia University class: OTHER name: Amal Ismael Abdelrahman Hassan name: Ibrahim Mowafy Gomaa Atawia briefSummary: The aim of this study is to compare between Thoracic Epidural Analgesia (TEA) with ultrasound-guided bilateral erector spinae plane (ESP) block in radical cystectomy surgery for analgesic efficacy and hemodynamic effects conditions: Post Operative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group A: will receive bilateral Erector Spinae Block after induction of anesthesia.

Group B: will receive Thoracic Epidural Block before induction of anesthesia. primaryPurpose: OTHER masking: NONE count: 20 type: ACTUAL name: bilateral Erector spine block,A dose of 30 ml 0.125% Bupivacaine will be injected. name: Thoracic epidural analgesia measure: Time for first rescue analgesia measure: Visual analogue scale score at 1st,2nd,4th,6th,8th,12th and 24 h (where 0 is interpreted as no pain, 1-4 mild pain, 5-6 moderate pain, 7-10 severe pain) measure: the number of rescue analgesics within 24hrs after surgery measure: The heart rate, mean arterial blood pressure measure: Complications like bradycardia or hypotension, intraoperative and postoperative dysrhythmia, nausea and vomiting sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Menoufia university city: Cairo state: Shibin Elkom country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06324240 id: STUDY00004185 id: NCI-2022-01950 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: STUDY00004185 type: OTHER domain: Emory University Hospital/Winship Cancer Institute id: WINSHIP5522-22 type: OTHER domain: Emory University Hospital/Winship Cancer Institute id: P30CA138292 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA138292 id: R44CA257278 type: NIH link: https://reporter.nih.gov/quickSearch/R44CA257278 briefTitle: Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-21 date: 2024-03-28 name: Emory University class: OTHER name: National Cancer Institute (NCI) briefSummary: This phase I trial tests the safety, side effects, and best dose of a personalized vaccine (tumor membrane vesicle or TMV vaccine) by itself and in combination with checkpoint inhibitor (pembrolizumab or ipilimumab) in treating patients with triple negative breast cancer. This vaccine is made by taking a piece of patient's triple negative breast cancer to design a vaccine to stimulate the immune system's memory. Patients are treated with the personalized vaccine immunotherapy with or without monoclonal antibodies, such as pembrolizumab and ipilimumab. This approach may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving personalized TMV vaccine with pembrolizumab or ipilimumab may help the immune system attack cancer better and reduce the risk of this breast cancer coming back or growing. conditions: Anatomic Stage I Breast Cancer AJCC v8 conditions: Anatomic Stage IA Breast Cancer AJCC v8 conditions: Anatomic Stage IB Breast Cancer AJCC v8 conditions: Anatomic Stage II Breast Cancer AJCC v8 conditions: Anatomic Stage IIA Breast Cancer AJCC v8 conditions: Anatomic Stage IIB Breast Cancer AJCC v8 conditions: Anatomic Stage III Breast Cancer AJCC v8 conditions: Anatomic Stage IIIA Breast Cancer AJCC v8 conditions: Anatomic Stage IIIB Breast Cancer AJCC v8 conditions: Anatomic Stage IIIC Breast Cancer AJCC v8 conditions: Anatomic Stage IV Breast Cancer AJCC v8 conditions: Early Stage Triple-Negative Breast Carcinoma conditions: Locally Advanced Triple-Negative Breast Carcinoma conditions: Metastatic Triple-Negative Breast Carcinoma conditions: Prognostic Stage I Breast Cancer AJCC v8 conditions: Prognostic Stage IA Breast Cancer AJCC v8 conditions: Prognostic Stage IB Breast Cancer AJCC v8 conditions: Prognostic Stage II Breast Cancer AJCC v8 conditions: Prognostic Stage IIA Breast Cancer AJCC v8 conditions: Prognostic Stage IIB Breast Cancer AJCC v8 conditions: Prognostic Stage III Breast Cancer AJCC v8 conditions: Prognostic Stage IIIA Breast Cancer AJCC v8 conditions: Prognostic Stage IIIB Breast Cancer AJCC v8 conditions: Prognostic Stage IIIC Breast Cancer AJCC v8 conditions: Prognostic Stage IV Breast Cancer AJCC v8 conditions: Recurrent Breast Carcinoma conditions: Unresectable Triple-Negative Breast Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Ipilimumab name: Pembrolizumab name: Vaccine Therapy measure: Incidence of adverse events (Phase Ia) measure: Dose limiting toxicity (Phase Ia) measure: Immune stimulating activity- T cell activity measure: Immune stimulating activity- Plasma cytokine/chemokines measure: Optimal biologic dose measure: Recommended phase 2 dose (Phase Ib) measure: Disease control rate measure: Overall response rate (ORR) measure: Progression free survival measure: Overall survival measure: PD-L1 expression measure: TIL density measure: BRCA 1/2 mutation status sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Grady Health System city: Atlanta state: Georgia zip: 30303 country: United States lat: 33.749 lon: -84.38798 facility: Emory University Hospital Midtown city: Atlanta state: Georgia zip: 30308 country: United States name: Deborah Omoyege role: CONTACT email: deborah.omoyege@emory.edu name: Keerthi Gogineni, MD, MSHP role: PRINCIPAL_INVESTIGATOR lat: 33.749 lon: -84.38798 facility: Emory University Hospital/Winship Cancer Institute city: Atlanta state: Georgia zip: 30322 country: United States name: Deborah Omoyege role: CONTACT email: deborah.omoyege@emory.edu name: Keerthi Gogineni, MD, MSHP role: PRINCIPAL_INVESTIGATOR lat: 33.749 lon: -84.38798 facility: Emory Saint Joseph's Hospital city: Atlanta state: Georgia zip: 30342 country: United States name: Deborah Omoyege role: CONTACT email: deborah.omoyege@emory.edu name: Keerthi Gogineni, MD, MSHP role: PRINCIPAL_INVESTIGATOR lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06324227 id: 311203003 briefTitle: Effects of Multimodal Music Intervention on Mild Cognitive Impairment Elderly overallStatus: RECRUITING date: 2023-09-17 date: 2024-03-26 date: 2024-05-26 date: 2024-03-21 date: 2024-03-21 name: National Yang Ming University class: OTHER briefSummary: The goal of this clinical trial is to learn about whether music therapy can ameliorate cognitive function, physical fitness and psychology in mild cognitive impairment and mild dementia population. The main questions it aims to answer are:

1. To build a model of multimodal music therapy.
2. To discuss the effect of twelve-week multimodal music therapy in ameliorating community-based elders with MCI and mild dementia. Main outcome variables: cognitive function (Montreal Cognitive Assessment Scale, trail making test, Saint Louis University Mental Status Examination). Secondary outcome variables: physical fitness (muscle strength, muscular endurance, flexibility, balance ability), depression. conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: multimodal music therapy name: no intervention measure: Montreal Cognitive Assessment measure: Saint Louis University Mental Status measure: Trail Making Test measure: 30s chair stand measure: back scratch test measure: sit and reach test measure: 8-foot up-and-go test measure: handgrip measure: Geriatric Depression Scale 15 items sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: NationalYangMingU status: RECRUITING city: Taipei country: Taiwan name: Wei Zu Lo role: CONTACT phone: 02-2823-9753 phoneExt: 66378 email: weitzu@nycu.edu.tw lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06324214 id: 2023-9352 briefTitle: Oral Supplementation During PR Participation in COPD overallStatus: RECRUITING date: 2024-03-11 date: 2025-03-04 date: 2025-05-31 date: 2024-03-21 date: 2024-04-02 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER name: Amazentis SA briefSummary: Chronic obstructive pulmonary disease (COPD) is a very common and chronic lung condition and is a leading cause of morbidity and death. These patients have persistent breathlessness and exercise intolerance, affecting their ability to carry out routine daily tasks. Standard COPD treatments include medicines/puffers as well as participation in a Pulmonary Rehabilitation (PR) program. PR programs are delivered by a diverse team of healthcare experts in exercise and nutrition. It is possible that an emerging nutritional oral supplement could target the muscular dysfunction seen in patients with COPD in part by promoting better working mitochondria, the energy 'engine' of muscle. A series of recently published studies in sedentary adults and in older adults have demonstrated the safety, tolerability, and potential clinical effectiveness of this supplement.

In this regard, the investigators plan to lead a large randomized controlled trial (RCT) to test whether oral supplementation in patients with COPD who are also participating in a standard PR program will improve overall exercise performance. The investigators will also test muscle strength, cognition, body composition, and other clinically important outcomes such as quality of life. Lastly, the investigators will use muscle tissue from a subgroup of volunteers to investigate the effect on muscle/mitochondrial structure/function.

The focus is actually the critical 'first step' before the larger RCT: a pilot and feasibility study on a smaller number of participants with COPD, as an important proof-of-concept that the larger study can, and should, be conducted. conditions: Copd studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 10 type: ESTIMATED name: Urolithin A (Mitopure) name: Placebo measure: Constant Work Rate Exercise Test (CRWET) measure: 6-Minute Walk Test (6MWT) measure: Quadriceps strength measure: Mitochondrial function measure: Muscle histology measure: Tissue microscopy measure: Tissue microscopy measure: Specific protein detection measure: RNA analyses measure: Body composition measure: Body impedance measure: Disease-specific impact on quality of life measure: Burden of disease measure: Cognition measure: Adverse events measure: Differences in dosed missed measure: Blood levels of the intervention sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: McGill University Health Centre status: RECRUITING city: Montréal state: Quebec zip: H4A 3J1 country: Canada name: Bryan A Ross, MD, FRCPC, MSc (Epi, Physiol) role: CONTACT phone: (514) 843-1465 email: bryan.ross@mcgill.ca lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06324201 id: QDOT PAS briefTitle: The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINT Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation. acronym: QDOT PAS overallStatus: RECRUITING date: 2024-02-27 date: 2026-03 date: 2028-03 date: 2024-03-21 date: 2024-03-21 name: Heart Rhythm Clinical and Research Solutions, LLC class: OTHER name: Biosense Webster, Inc. briefSummary: Observational, multi-center, non-randomized, post-market study. This is a nested sub-study of the REAL AF Registry. Consecutive symptomatic drug refractory paroxysmal atrial fibrillation (PAF) patients from the registry will be screened for enrollment to this sub-study per inclusion and exclusion criteria. conditions: Paroxysmal Atrial Fibrillation studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Ablation Procedure measure: Safety of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module measure: Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 12-months. measure: Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 24-months. measure: Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 36-months. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centra Health, Inc.dba Stroobants Cardiovascular Center status: RECRUITING city: Lynchburg state: Virginia zip: 24501 country: United States name: Cindy Baumann role: CONTACT name: Mathhew Sackett role: PRINCIPAL_INVESTIGATOR lat: 37.41375 lon: -79.14225 facility: Mercy Health status: RECRUITING city: Janesville state: Wisconsin zip: 53548 country: United States name: Kaitlyn Phetteplace role: CONTACT name: Imdad Ahmed role: PRINCIPAL_INVESTIGATOR lat: 42.68279 lon: -89.01872 hasResults: False

 nctId: NCT06324188 id: EASThigh-AFNET 11 briefTitle: Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11) overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2030-02 date: 2030-05 date: 2024-03-21 date: 2024-03-21 name: Atrial Fibrillation Network class: OTHER briefSummary: EASThigh-AFNET 11 is an international, prospective, randomized, open, blinded endpoint assessment, multicenter trial (Treatment Strategy trial).

The objective of EASThigh-AFNET 11 is to investigate whether early atrial fibrillation ablation in patients with atrial fibrillation (AF) and a high comorbidity burden (CHA2DS2-VASc ≥4) reduces cardiovascular events (stroke, cardiovascular death, or heart failure events) compared to usual care. conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE maskingDescription: blinded endpoint assessment whoMasked: OUTCOMES_ASSESSOR count: 2312 type: ESTIMATED name: Early atrial fibrillation ablation name: Usual Care measure: Composite of cardiovascular complications related to AF measure: The primary safety outcome is a composite of all-cause death and serious complications of AF therapy. measure: Number of nights spent in hospital measure: Time from randomisation to first occurrence of each of the individual components of the primary outcome measure: All-cause death measure: Serious adverse events related to AF therapy measure: Time from randomisation to first cardiovascular hospitalisation measure: Number of cardiovascular hospitalisations (over-night stay) measure: Changes in left ventricular ejection fraction measure: Changes in quality of life measure: Changes in quality of life measure: Changes in cognitive function measure: Cardiac rhythm status measure: AF pattern measure: Time from randomisation to first clinical recurrence of AF measure: Time from randomisation to first progression of AF sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Several sites city: Multiple Locations country: Australia facility: Several sites city: Multiple Locations country: Canada facility: Several sites city: Multiple Locations country: Germany facility: Several sites city: Multiple Locations country: Netherlands facility: Several sites city: Multiple Locations country: United Kingdom hasResults: False

 nctId: NCT06324175 id: 6353 briefTitle: Spatial Radiogenomics of Ovarian Cancer: Implementation of a Lesion-specific 3D-printed Mould Pipeline in the Clinical Workflow for Image-guided Tissue Multi-sampling of Ovarian Tumours acronym: CO-MOULD overallStatus: RECRUITING date: 2024-02-01 date: 2025-12-31 date: 2026-12-31 date: 2024-03-21 date: 2024-03-21 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The biological spatial and temporal heterogeneity of High Grade Serous Ovarian Carcinoma (HGSOC) severely impacts the effectiveness of therapies and is a determinant of poor outcomes.

Current histological evaluation is made on a single tumour sample from a single disease site per patient thus ignoring molecular heterogeneity at the whole-tumour level, key for understanding and overcoming chemotherapy resistance. Imaging can play a crucial role in the development of personalised treatments by fully capturing the disease's heterogeneity.

Radiomics quantify the image information by capturing complex patterns related to the tissue microstructure. This information can be complemented with clinical data, liquid biopsies, histological markers and genomics ("radiogenomics") potentially leading to a better prediction of treatment response and outcome. However, the extracted quantitative features usually represent the entire tumour, ignoring the spatial context.

On the other hand, radiomics-derived imaging habitats characterize morphologically distinct tumour areas and are more appropriate for monitoring the changes in the tumour microenvironment over the course of therapy. In order to successfully incorporate the habitat-imaging approach to the clinic, histological and biological validation are crucial. However, histological validation of imaging is not a trivial task, due to issues such as unmatched spatial resolution, tissue deformations, lack of landmarks and imprecise cutting. Patient-specific three-dimensional (3D) moulds are an innovative tool for accurate co-registration between imaging and histology. The aim of this study is to optimize and integrate such an automated computational 3D-mould co-registration approach in the clinical work-flow in patients with HGSOC. The validated radiomics-based tumour habitats will also be used to guide tissue sampling to decipher their underlying biology using genomics analysis and explore novel prediction markers. conditions: Ovarian Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 24 type: ESTIMATED measure: Implementation of the 3D printing pipeline in the clinical setting for recurrent HGSOC measure: Biological validation of spatial radiomics in HGSOC sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Advanced Radiology Center status: RECRUITING city: Roma zip: 00168 country: Italy name: Camilla Panico, MD role: CONTACT phone: +390630158637 lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06324162 id: JagiellonianU Gibas-Stanek briefTitle: Does the Pain Experienced During Orthodontic Treatment and Bracket Removal Depend on the Architecture of the Bracket? acronym: Debonding overallStatus: COMPLETED date: 2021-10-01 date: 2023-05-01 date: 2023-05-01 date: 2024-03-21 date: 2024-03-21 name: Piotr Fudalej class: OTHER briefSummary: The present research aimed to thoroughly investigate the impact of bracket architecture on pain perception during active treatment, debonding, and adhesive removal. conditions: Debonding conditions: Orthodontic Brackets studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 100 type: ACTUAL name: bracket removal pliers, LODI measure: Pain during active treatment measure: Pain during brackets removal measure: Pain on adhesive removal sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Jagiellonian University Collegium Medicum city: Kraków zip: 31-008 country: Poland lat: 50.06143 lon: 19.93658 hasResults: False

 nctId: NCT06324149 id: AGE-IT-FRAILTY briefTitle: Age-related Conditions in the Context of Multimorbidity and Frailty: Relative Weight of Frailty in Determining the Course and Outcomes of Different Chronic Diseases and Viceversa acronym: AGE-IT-FRAILTY overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-02-28 date: 2026-04-30 date: 2024-03-21 date: 2024-03-21 name: IRCCS San Raffaele class: OTHER briefSummary: Observational study. Participants of the FRASNET study (9th March 2017, Protocol No. 24/INT/2017) who were evaluated in 2016 and 2017 will be contacted to be re-evaluated with multidimensional visits as part of the present study in order to assess trajectories and biomarkers of frailty and sarcopenia. Moreover, are going to evaluate with the same multidimensional visits patients with mild cognitive impairment and dementia followed up at the Neurologic Unit of the San Raffaele Hospital. conditions: Frailty conditions: Sarcopenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: completion of scales and questionnaires; venous blood sampling; muscle ultrasound; cardiac ultrasound; electrocardiogram; bioelectrical impedance analysis measure: identify new molecular markers of frailty and sarcopenia measure: evaluate the ability of new markers for frailty, sarcopenia, cognitive impairment sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: San Raffaele Hospital city: Milan country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06324136 id: KIDNEY-PNRR briefTitle: Validation, Implementation, and Cost-analysis of a Strategy for Personalized Diagnosis of Rare Kidney Diseases overallStatus: RECRUITING date: 2023-07-06 date: 2026-07-31 date: 2026-12-30 date: 2024-03-21 date: 2024-03-21 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Chronic kidney disease (CKD) affects about 10% of the world population, with high morbidity and mortality. Genetic kidney diseases are increasingly recognized across all age groups and represent over 20% of all the causes of CKD. Accurate diagnosis allows necessary and unnecessary diagnostic procedures to be defined, avoids unnecessary treatments, improves prognosis prediction, identifies other family members for genetic counseling, and defines risks for living donor kidney transplantation. The research group coordinated by the Principal Investigator has recently developed an algorithm for the genetic diagnosis in pediatric and adult patients with CKD. The application of this personalized diagnostic algorithm on a local study led to a global diagnostic yield of 70%, suggesting that this strategy has the potential to substantially improve the diagnostic approach to patients with rare kidney disorders. The aim of this study is to validate and implement these results by extending its application in a multicentric study involving nephrology units that are referral centers for rare kidney diseases at national level. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 300 type: ESTIMATED name: Implementation of the diagnostic algorithm measure: Implementation of a diagnostic algorithm for personalized diagnosis of rare kidney diseases measure: Analysis of the functional role of variant of unknown clinical significance (VUS) measure: Identification of immunological and/or structural factors in genetic and nongenetic forms. measure: Cost-effectiveness of the diagnostic algorithm. sex: ALL minimumAge: 0 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Firenze country: Italy name: Paola Romagnani role: CONTACT lat: 43.77925 lon: 11.24626 facility: Azienda Ospedaliero Universitaria Vanvitelli status: RECRUITING city: Napoli country: Italy name: Miriam Zacchia role: CONTACT lat: 40.85216 lon: 14.26811 facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone status: RECRUITING city: Palermo country: Italy name: Santina Cottone role: CONTACT lat: 38.13205 lon: 13.33561 hasResults: False

 nctId: NCT06324123 id: 23C304 briefTitle: Observational Study Aimed at Evaluating the Trend of Neuropathic Pain acronym: NEURATIL overallStatus: RECRUITING date: 2023-06-09 date: 2024-12-31 date: 2024-12-31 date: 2024-03-21 date: 2024-03-25 name: Istituto Auxologico Italiano class: OTHER briefSummary: The present study aims to evaluate the trend of neuropathic pain in patients treated with Peacetil for a period of two months.

Neuropathic pain will me assessed through the Numeric Rating Scale (NRS) questionnaire score. conditions: Neuropathic Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Peacetil measure: Change in neuropathic pain after two months of treatment with Peacetil measure: Change in neuropathic pain after one month of treatment with Peacetil sex: ALL minimumAge: 18 Years maximumAge: 82 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano status: RECRUITING city: Milan state: Lombardy zip: 20149 country: Italy name: Luca Maderna, MD role: CONTACT phone: 0261911 email: l.maderna@auxologico.it name: Alberto Doretti, MD role: CONTACT phone: 0261911 phoneExt: 2937 email: neurotrial@auxologico.it lat: 45.46427 lon: 9.18951 facility: ASST Fatebenefratelli Sacco status: NOT_YET_RECRUITING city: Milano zip: 20157 country: Italy name: Fabrizio Gervasoni, MD role: CONTACT email: fabrizio.gervasoni@asst-fbf-sacco.it lat: 45.46427 lon: 9.18951 facility: Fondazione Don Carlo Gnocchi ONLUS status: NOT_YET_RECRUITING city: Milano country: Italy name: Angela Comanducci, MD role: CONTACT email: acomanducci@dongnocchi.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06324110 id: RG1124119 id: NCI-2024-01763 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 20250 type: OTHER domain: Fred Hutch/University of Washington Cancer Consortium id: R01CA284032 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA284032 briefTitle: Evaluating the Impact of Centralized Interventions on Lung Cancer Screening Adherence in Community Settings, ACCELL Trial overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2027-06-30 date: 2027-06-30 date: 2024-03-21 date: 2024-04-10 name: Fred Hutchinson Cancer Center class: OTHER name: National Cancer Institute (NCI) briefSummary: This clinical trial tests the impact of lung cancer screening care coordination interventions implemented at the system-level on lung cancer screening adherence in community settings. Lung cancer remains the leading cause of cancer death in the United States. Although lung cancer screening (LCS) with yearly low-dose chest computed tomography has the potential to decrease lung deaths, the use of this screening technique remains low. In addition, studies have shown that adherence to lung cancer screening in clinical settings is far lower that those found in clinical trials. Improved care coordination services that include comprehensive, system-wide tracking of screening outcomes for all LCS participants, results reporting with direct-to-patient information, direct patient and physician communication, and active reviews of non-adherent patients and stepped support interventions may increase patient adherence to LCS. Coordination services at the system-level may decrease barriers and improve adherence to lung cancer screening in community settings. conditions: Lung Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 8658 type: ESTIMATED name: Electronic Health Record Review name: Interview name: Patient Navigation measure: Adherence to appropriate follow-up measure: Characteristics associated with adherence to follow up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fred Hutch/University of Washington Cancer Consortium city: Seattle state: Washington zip: 98109 country: United States name: Tinnie Louie role: CONTACT phone: 206-667-3323 email: tlouie@fredhutch.org name: Matthew Triplette role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06324097 id: 2024-357 briefTitle: Diagnostic Value of Endocytoscopy for Colorectal Lesions overallStatus: RECRUITING date: 2024-04-01 date: 2024-05 date: 2024-05 date: 2024-03-21 date: 2024-04-18 name: Hong Xu class: OTHER briefSummary: Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related death worldwide. Colonoscopy is considered the preferred method of screening for colorectal cancer, and resection of colorectal lesions can significantly reduce the incidence and mortality of colorectal cancer. In order to improve the qualitative and quantitative diagnosis of colorectal lesions, many endoscopic techniques, such as image-enhanced endoscopy (IEE), including narrowband imaging (NBI), magnifying endoscopy, pigment endoscopy, confocal laser endoscopy, and endocytoscopy (EC) are applied clinically. The application of EC is intended to achieve the purpose of real-time histopathological endoscopic diagnosis without biopsy. Several studies have shown that EC is effective in identifying the nature of colorectal lesions and judging the depth of invasion in CRC. Based on the endoscopic diagnosis, the endoscopist can determine the treatment plan for the colorectal lesions. The latest EC is an integrated endoscope with a contact light microscopy system with a maximum magnification of 520 x. EC may demonstrate the atypical of gland structure and cells after staining (EC staining mode, along with the use of the EC-NBI mode. The endoscopic diagnosis of the EC staining mode is based on the EC classification (EC-C), used to predict the histopathological diagnosis of colorectal lesions. A prospective randomized trial showed that the diagnostic accuracy was 94.1% by EC-C. However, the diagnostic value of EC-C depends on the operator and may be influenced by the quality of the staining. Meanwhile, the high-quality staining process is time-consuming and tedious. Therefore, EC-NBI seems to be the first choice for EC diagnosis with the advantages of convenient operation and efficient diagnosis. EC-NBI can display the super-amplified surface microvessels of the lesion and provide pathological prediction according to the vessel classification (EC-V). EC-V achieved 99% diagnostic accuracy for hyperplastic polyps and 88.6% for invasive carcinoma. In EC examination, the investigators usually use EC-NBI and EC staining successively to diagnose colorectal lesions, which is believed to improve the diagnostic performance. However, the diagnostic value of increasing EC-staining after EC-NBI examination for predicting the pathological nature of colorectal lesions is still unclear. Therefore, this retrospective study aimed to evaluate the diagnostic value of two different modalities of cell endoscopy for colorectal lesions and to clarify whether additional EC staining after EC-NBI could improve the diagnostic performance of predicting the pathological diagnosis of colorectal lesions.

In the study, the investigators collect clinical information of colorectal lesions which were diagnosed by endoscopic diagnosis (including EC-NBI and EC-staining) and pathological diagnosis. Then, the investigators calculate the accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and high confidence diagnosis rate of EC-C and EC-V classification, respectively. Inter-and intra-observer agreement in the diagnosis of EC-C and EC-V will be calculated. conditions: Colorectal Neoplasms studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 500 type: ESTIMATED name: endocytoscopy measure: sensitivity measure: specificity measure: accuracy measure: positive predictive value measure: negative predictive value measure: inter-observer agreement measure: intra-observer agreement sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: the Department of Gastroenterology and Endoscopy Center, First Hospital of Jilin University status: RECRUITING city: Changchun state: Jilin zip: 130021 country: China name: Mingqing Liu, Doctor role: CONTACT phone: +8613204300453 email: liumq23@mails.jlu.edu.cn name: Hong Xu, Doctor role: PRINCIPAL_INVESTIGATOR name: Mingqing Liu, Doctor role: SUB_INVESTIGATOR name: Nan Zhang, Doctor role: SUB_INVESTIGATOR lat: 43.88 lon: 125.32278 hasResults: False

 nctId: NCT06324084 id: 05M201 briefTitle: PATHophysiology of OSteoporosis: Role of Hidden Cortisol Excess and Its Predictors in Bone Fragility acronym: PATHOS overallStatus: RECRUITING date: 2023-04-24 date: 2024-10-24 date: 2025-04-24 date: 2024-03-21 date: 2024-03-21 name: Istituto Auxologico Italiano class: OTHER briefSummary: Osteoporosis is a chronic skeletal disease which leads to a decrease in bone strength which increases the risk of fractures.

Clinically overt hypercortisolism leads to hypertension, central obesity, diabetes and osteoporosis. More recently, even the condition of mild and asymptomatic hypercortisolism has been associated with increased prevalence of chronic complications of cortisol excess and mortality. In patients with osteoporosis this form of hypercortisolism may remain occult (hidden hypercortisolism, HidHyCo).

Although asymptomatic, however, this subtle cortisol excess is associated with an increased risk of osteoporosis and fragility fractures.

Moreover, HidHyCo prevalence seems to be increased in osteoporotic patients. The HidHyCo case finding is of utmost importance. However, given the high prevalence of bone fragility and the relatively low diagnostic accuracy of the currently available tests for the HidHyCo detection, a mass screening for HidHyCo is considered unthinkable. As now, no guidelines are available for addressing the HidHyCo screening in osteoporosis.

Therefore, the aims of the present study are the following: i) to assess the HidHyCo prevalence in a sample of osteoporotic patients; ii) to compare the clinical characteristics between osteoporotic/osteopenic patients with HidHyCo and those without HidHyCo in order to determine the clinical characteristics more frequently associated with the HidHyCo presence and to identify those osteoporotic patients worthy of HidHyCo screening; iii) to further investigate bone quality and turnover in HidHyCo patients, to characterize HidHyco patients from a molecular and genetic point of view and to evaluate the pathogenetic mechanisms explaining the negative effects of endogenous cortisol excess on bone health in these patients and the potential role of the genetic background and of the gut microbiome.

The HidHyCo could be present in a not negligible percentage of osteopenic/osteoporotic patients. In these patients, osteoporosis and, if present, other comorbidities can improve by the surgical resection of the adrenal or pituitary adenoma if feasible, or by the use of drugs able to modulate cortisol secretion or glucocorticoid sensitivity. Moreover, the case-finding could be reserved in those patients at higher risk of having HidHyCo, therefore, reducing the costs of a scarcely specific mass screening. conditions: Osteoporosis conditions: Bone Fracture conditions: Cortisol Excess studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 1500 type: ESTIMATED measure: Prevalence of hidden hypercortisolism in osteoporosis measure: Statistical comparison of the clinical and biochemical characteristics of osteoporotic/osteopenic patients with HidHyCo and those without HidHyCo to identify the characteristics predictive of the presence of HidHyCo in osteoporosis measure: Further investigation of bone turnover in HidHyCo patients, as assessed by serum osteocalcin, CrossLaps, bone alkaline phosphatase and amino-terminal propeptide of type 1 procollagen (P1NP) and additional new potential serum markers of bone status. measure: Further investigation of bone quality as assessed by Radiofrequency Echographic Multi Spectrometry (REMS) measure: Characterization of HidHyco patients from a molecular and genetic point of view by the determination of circulating microRNAs, peripheral glucocorticoid activity and the polymorphic variants of the 11ßHSD1, GR and B2AR gene. measure: Assessment of gut microbiome composition by the analysis of fecal samples sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliera Universitaria Policlinico "G. Rodolico-San Marco" status: NOT_YET_RECRUITING city: Catania country: Italy name: Agostino Gaudio, Professor role: CONTACT lat: 37.49223 lon: 15.07041 facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: RECRUITING city: Milan country: Italy name: Cristina Eller-Vainicher, MD role: CONTACT name: Giorgia Grassi, MD role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: Istituto Auxologico Italiano IRCCS status: RECRUITING city: Milan country: Italy name: Elisa Cairoli, MD role: CONTACT name: Carmen Aresta, MD role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: Ospedale "Casa Sollievo della Sofferenza" IRCCS status: RECRUITING city: San Giovanni Rotondo country: Italy name: Alfredo Scillitani, MD role: CONTACT name: Flavia Pugliese, MD role: SUB_INVESTIGATOR lat: 41.70643 lon: 15.7277 facility: Azienda Ospedaliera Universitaria Senese status: NOT_YET_RECRUITING city: Siena country: Italy name: Luigi Gennari, Professor role: CONTACT lat: 43.31822 lon: 11.33064 hasResults: False

 nctId: NCT06324071 id: 2022_TSOD_125 briefTitle: Study to Verify the Efficacy of a Product Containing 125 mg of TetraSOD® for the Treatment of Male Infertility overallStatus: RECRUITING date: 2024-01-08 date: 2025-01 date: 2025-04 date: 2024-03-21 date: 2024-03-22 name: Fitoplancton Marino, S.L. class: INDUSTRY name: Fundacio Clinic Barcelona name: Fertypharm briefSummary: TetraSOD® is a unique marine phytoplankton (Tetraselmis chuii) SOD-rich ingredient that is grown under patent-protected technology exclusively designed by the company Fitoplancton Marino, S.L. (Spain). In a previous pilot trial, the ability of TetraSOD® (dose: 250 mg/day) to improve semen characteristics in idiopathic infertile men after three months of treatment was assessed, revealing significant improvements in almost all of the analyzed parameters. In a further clinical trial close to finish (ClinicalTrials.gov Identifier: NCT04864314) using the same dose, such positive results have been tested again in a higher number of patients, and additional parameters have been included in order to gain insights into the sperm physiological changes that underpin the improvement in semen quality. In this new clinical trial, an intermediate dose (125 mg/day) is going to be tested in an attempt to determine a range of TetraSOD® dosage being clinically active for the treatment of male infertility. conditions: Male Infertility studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 50 type: ESTIMATED name: Sham name: Marine microalgae Tetraselmis chuii with high Superoxide Dismutase (SOD) activity measure: Sperm motility measure: Sperm concentration measure: Sperm oxidative stress measure: DNA integrity measure: sORP by MiOXSYS measure: Adverse effects sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Hospital Clinic status: RECRUITING city: Barcelona zip: 08036 country: Spain name: Juan M Corral role: CONTACT phone: +34 932275545 email: jmcorral@clinic.cat name: Meritxell Jodar role: CONTACT phone: +34 932275510 email: mjodar@clinic.cat name: Marta Guimerà role: SUB_INVESTIGATOR name: Juan M Mayorga-Torres role: SUB_INVESTIGATOR name: Antonio Alcaraz role: SUB_INVESTIGATOR name: Dolors Manau role: SUB_INVESTIGATOR name: Rafael Oliva role: SUB_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06324058 id: Huashan_H briefTitle: Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2025-03-18 date: 2026-03-18 date: 2024-03-21 date: 2024-03-21 name: Huashan Hospital class: OTHER briefSummary: This trial plans to enroll 190 eligible patients and randomize them into two groups with a 1:1 ratio, with 95 patients in each group. The experimental group will receive immediate cryoablation therapy at the resection site after TUR, while the control group will only undergo TUR and receive conventional BCG instillation therapy postoperatively. Both groups of subjects will undergo Re-TURBT or cystoscopy 10-12 weeks after surgery to compare the tumor-free residual rates and adverse events between the two groups. conditions: Bladder Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 190 type: ESTIMATED name: Transurethral cryoablation name: Transurethral resection of bladder tumor name: Bcg Intravesical measure: Tumor residual rate measure: Recurrence measure: Progression sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06324045 id: MRC-01-22-314 briefTitle: Deprescribing Intervention for Patients With Chronic Kidney Disease overallStatus: RECRUITING date: 2024-02-19 date: 2025-08-31 date: 2025-08-31 date: 2024-03-21 date: 2024-03-21 name: Hamad Medical Corporation class: INDUSTRY name: Qatar University name: Winchester District Memorial Hospital briefSummary: Chronic Kidney Disease (CKD) is recognized as a leading health problem globally. It is associated with multiple consequences such as cardiovascular diseases, infections, reduced cognitive function, and higher mortality rates. In Qatar, it is estimated that 13% of the population suffers from CKD. Management of CKD is associated with polypharmacy (the use of multiple medications), which burdens the patients and leads to adverse health and economic outcomes. As documented by previous studies, CKD setting is associated with a high medication burden, which leads to non-adherence, reduced quality of life, and other negative sequelae. These consequences can be minimized or averted by implementing a deprescribing program. Deprescribing is defined as the supervised process of intentionally stopping a medication, altering the dose or introducing a safer alternative to improve a person's clinical and quality of life outcomes. Previous deprescribing initiatives in inpatient and outpatient hospital settings were successfully implemented.

In general, there are limited deprescribing initiatives in CKD settings. There is a need to provide evidence of the impact of deprescribing programs on improving clinical and economic outcomes in this setting. In Qatar, there is no evidence of the effectiveness of implementing deprescribing programs in clinical settings. Therefore, we have built a team of researchers, clinicians, and stakeholders, and initiated a collaboration with deprescribing experts to fit into the Qatar healthcare system. This project aims to initiate a deprescribing multidisciplinary team and to evaluate the impact of providing such services on the clinical and economic outcomes among CKD patients in Qatar using a randomized controlled trial approach. The findings could have a potential positive impact on the professional practice and patient safety represented by health and economic outcomes. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: CKD patients will be screened using medical records. Eligible patients will be approached during their routine visits to FBJ Kidney Center and other ambulatory kidney centers. Due to feasibility and practicality issues, selecting the patients will be consecutive case series as per their availability during the time of the recruitment (nonprobabilistic).

After obtaining informed consent, patients will be randomized into one of the two study arms. Randomization will be stratified by dialysis dependency (dialysis vs. pre-dialysis); randomly permuted balanced block sizes of 4 for dialysis patients and 1 for pre-dialysis will be used. Neither the practitioners nor the patients will be blinded to the patients' allocated groups due to the nature of the intervention. Due to feasibility and practicalities, selecting the patients will be consecutive as per their availability during the time of the recruitment (non-probabilistic). primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 424 type: ESTIMATED name: Deprescribing measure: Percentage of participants with at least one Potentially inappropriate medications (PIMs) measure: Number of Potentially inappropriate medications (PIMs) measure: Pill burden measure: Health-related quality of life (HRQoL) measure: Treatment burden measure: Self-reported adherence measure: Medication Refills adherence measure: Emergency department visits and hospitalizations measure: Unanticipated adverse effects measure: Cost avoidance measure: Cost savings sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hamad Medical Corporation status: RECRUITING city: Doha state: Unlisted (UL) zip: 00000 country: Qatar name: Abdulla Hamad, MD role: CONTACT phone: +97444394804 email: ahamad9@hamad.qa name: Rania Ibrahim, MSc. role: CONTACT phone: +9744394808 email: ribrahim4@hamad.qa name: Abdulla Hamad, MD role: PRINCIPAL_INVESTIGATOR name: Ahmed Awaisu, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Daoud Al-Badriyeh, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Muhammad Abdul Hadi, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Ali Elbeddini, Pharm D role: SUB_INVESTIGATOR name: Rania Ibrahim, MSc. role: SUB_INVESTIGATOR name: Amani Zidan, MSc. role: SUB_INVESTIGATOR name: Kheloud Khaled, Pharm D role: SUB_INVESTIGATOR lat: 25.28545 lon: 51.53096 hasResults: False

 nctId: NCT06324032 id: 021-FPO20 briefTitle: SUNNYDAY: SUbepithelialgastroiNtestiNal Tumors Detection,accuracYDiAgnosis,ElastographY and Contrast-enhanced EUS acronym: SunnyDay021 overallStatus: RECRUITING date: 2020-12-17 date: 2025-06-30 date: 2025-12-31 date: 2024-03-21 date: 2024-03-21 name: Fondazione del Piemonte per l'Oncologia class: OTHER briefSummary: This will be a longitudinal, prospective, observational multicenter study where the role of EUS-E will be examined in differentiating subepithelial gastrointestinal tumors in 138 patients conditions: Subepithelial Gastrointestinal Tumors studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 138 type: ESTIMATED name: EUS Elastography (EUS-E) measure: Evaluation of EUS-E accuracy qualitative measure: Evaluation of EUS-E accuracy quantitative measure: Evaluation of diagnostic accuracy of EUS-biopsy with fine needle biopsy (FNB) measure: Evaluation of gene mutations in EUS-guided specimen measure: Correlation of elastographic and contrastographic characteristics of SETs with the pathological risk stratification. measure: Complication rate (perforations, bleeding) of the procedure sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale Santa Maria della Scaletta status: RECRUITING city: Imola state: Bologna country: Italy name: Pietro Fusaroli, MD role: CONTACT lat: 44.35916 lon: 11.7132 facility: Istituto Clinico Humanitas status: RECRUITING city: Rozzano state: Milano country: Italy name: Silvia Carrara, MD role: CONTACT lat: 45.38193 lon: 9.1559 facility: Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo status: RECRUITING city: Candiolo state: Turin, zip: 10060 country: Italy name: Teresa Staiano, MD role: CONTACT phone: +390119933413 email: teresa.staiano@ircc.it lat: 44.95858 lon: 7.59812 facility: Ospedale Humanitas Mater Domini status: RECRUITING city: Castellanza state: Varese country: Italy name: Benedetto Mangiavillano, MD role: CONTACT lat: 45.61079 lon: 8.89616 facility: AOU Maggiore della Carità status: RECRUITING city: Novara zip: 28100 country: Italy name: Pietro Occhipinti, MD role: CONTACT lat: 45.44694 lon: 8.62118 facility: Istituto Oncologico Veneto status: RECRUITING city: Padova country: Italy name: Alberto Fantin, MD role: CONTACT lat: 45.40797 lon: 11.88586 facility: AOU Città della Salute e della Scienza di Torino, Ospedale Molinette status: RECRUITING city: Turin zip: 10126 country: Italy name: Claudio G. De Angelis, MD role: CONTACT lat: 45.07049 lon: 7.68682 hasResults: False

 nctId: NCT06324019 id: Ethics number E.405221 briefTitle: Gynaecological Examination Gown and Patient Satisfaction overallStatus: COMPLETED date: 2022-02-01 date: 2022-04-30 date: 2022-06-22 date: 2024-03-21 date: 2024-03-21 name: ayşegül muslu class: OTHER briefSummary: The attitude of the health personnel before, during and after the examination and the positive examination experience of the person have a significant impact on ensuring the continuity of the subsequent examination and increasing the quality of the service provided. The use of different clothes in the patient during the examination will ensure that the patient\&#39;s physical privacy is ensured from the moment of application, during diagnosis and treatment, and that the examination experience will be positively affected by preventing the use of additional covers to protect the privacy of all patients during examination and intervention. This will contribute to the maintenance of health by eliminating the intense stress and embarrassment experienced by patients during the examination and ensuring that they regularly attend health checks. In addition, meeting the privacy expectations of the patients will ensure that they are satisfied with the health service they receive, thus increasing the quality of the health service provided.

The attitude of the health personnel before, during and after the examination and the positive examination experience of the person have an important effect on ensuring the continuity of the subsequent examination and increasing the quality of the service provided. With the examination suit, it will be ensured that the patient\&#39;s bodily privacy is ensured from the moment of application, during diagnosis, treatment and care, the use of the same cover to protect the privacy of all patients during examination and intervention will be prevented to prevent infection transmission and the examination experience will be positively affected. Thus, the intense stress and embarrassment experienced by patients during the examination will be eliminated and will contribute to the maintenance of health through regular visits to health checks. In addition, meeting the privacy expectations of patients will ensure that they are satisfied with the health service they receive, thus increasing the quality of the health service provided. In order to ensure patient privacy, to protect and improve women\&#39;s health and to provide convenience in gynecological examination, the gynecological examination garment to be used in the examination can be designed as disposable, perineum and thigh open for the examination to be performed. In order to protect privacy, extra parts can be used to ensure that the open parts remain closed outside the examination process. Properties of the fabric used in the examination garment;

* Grama: 32,07 g/m\^2
* Explosion.: 135,77 kpç
* Detachment: Ȼ: 115NȺ: 120 N
* Air permeability: 1750
* Type of material: Polypropylene

The study was carried out as a post-test control group design from randomised controlled studies. The intervention group of the study was dressed in gynaecological examination clothes, while the control group used the drape given to the patient during the examination, which is a routine practice in the health institution where the study was conducted. conditions: Gynecology conditions: Gynecology/Obstetrics Conditions studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study was carried out as a post-test control group design from randomised controlled studies. The intervention group of the study was dressed in gynaecological examination clothes, while the control group used the drape given to the patient during the examination, which is a routine practice in the health institution where the study was conducted.

Hypotheses of the Study

1. Ho: There is no difference between the perception of privacy in the experimental and control group women.

   H1: There is a difference between the perception of privacy in the experimental group and control group women.
2. Ho: There is no difference between the perception of satisfaction in the experimental group and control group women.

H1: There is a difference between the satisfaction perception of women in the experimental group and the control group. primaryPurpose: OTHER masking: NONE count: 150 type: ACTUAL name: putting on an examination gown measure: Gynaecological examination gown sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: EGE city: İzmir state: Konak country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06324006 id: DCT3934 briefTitle: A Phase 1 Trial of LIB-01 in Healthy Participants. overallStatus: ACTIVE_NOT_RECRUITING date: 2023-08-25 date: 2024-05-30 date: 2024-05-30 date: 2024-03-21 date: 2024-03-27 name: Dicot AB class: INDUSTRY briefSummary: The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetics of LIB-01 in healthy male participants. The main questions it aims to answer are:

* How safe and tolerable is LIB-01 when given once or repeatedly at different dose levels.
* What are the pharmacokinetic characteristics of LIB-01

Participants will receive LIB-01 and be followed up for safety and pharmacokinetics by:

* Adverse events
* ECG
* Blood sampling for laboratory parameters and pharmacokinetic analysis conditions: Erectile Dysfunction studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a Phase I, double-blind, parallel-group, placebo-controlled, randomized first-in-human trial. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 64 type: ACTUAL name: LIB-01 name: Placebo measure: To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following a single oral dose of LIB-01. measure: To evaluate changes in vital signs in healthy male participants, following a single oral dose of LIB-01. measure: To evaluate changes in ECG in healthy male participants, following a single oral dose of LIB-01. measure: To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following multiple oral dosing of LIB-01. measure: To evaluate changes in vital signs in healthy male participants, following a multiple oral dosing of LIB-01. measure: To evaluate changes in ECG in healthy male participants, following multiple oral dosing of LIB-01. measure: To characterise the maximum plasma concentration of LIB-01, following a single oral dose. measure: To characterise the plasma concentration half life of LIB-01, following a single oral dose. measure: To characterise the plasma concentration area under curve of LIB-01, following a single oral dose. measure: To characterise the maximum plasma concentration of LIB-01 following multiple oral dosing. measure: To characterise the plasma concentration half life of LIB-01 following multiple oral dosing. measure: To characterise the plasma concentration half life of LIB-01 following multiple oral dosing. sex: MALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Trial Consultants city: Uppsala zip: 75237 country: Sweden lat: 59.85882 lon: 17.63889 hasResults: False

 nctId: NCT06323993 id: 2021-115 briefTitle: The Effect of Different Window-preparation Approaches on the Clinical Outcomes of Lateral Sinus Floor Elevation overallStatus: COMPLETED date: 2022-03-01 date: 2022-05-01 date: 2023-06-15 date: 2024-03-21 date: 2024-03-21 name: The Dental Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: This study retrospectively evaluated the effect of two different lateral window preparation techniques on peri-implant bone augmentation for patients who underwent lateral sinus floor elevation with simultaneous implant placement using two-dimensional and three-dimensional radiographic results, with special emphasis placed on the stability of the graft material after surgery. conditions: Dental Implantation conditions: Cone-Beam Computed Tomography conditions: Surgical Procedure, Unspecified conditions: Maxillary Sinus Floor Augmentation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 34 type: ACTUAL name: Piezoelectric osteotomy measure: Apical bone height measure: Endo-sinus bone gain measure: Palatal bone height measure: Buccal bone height measure: Augmentation volume measure: Perforation incidence measure: Early implant loss measure: Lateral window length measure: Lateral bone length sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06323980 id: DSM202108 briefTitle: INHANCE Stemless Reverse Shoulder IDE overallStatus: NOT_YET_RECRUITING date: 2024-09-15 date: 2027-11-10 date: 2028-04-10 date: 2024-03-21 date: 2024-04-24 name: DePuy Orthopaedics class: INDUSTRY briefSummary: 2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder. conditions: Arthroplasty conditions: Replacement conditions: Shoulder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2:1 Randomized (Stemless to Stemmed) primaryPurpose: TREATMENT masking: NONE count: 168 type: ESTIMATED name: Reverse Total Shoulder measure: Constant Murley Score (CMS) measure: Removal of any system component measure: Revision of any system component measure: Reoperation of any system component measure: Supplemental Fixation of any system component measure: Radiolucent Lines (Humeral & Glenoid) measure: Migration and Tilt (Humeral & Glenoid) measure: Constant Murley Score (CMS) measure: EQ-5D-5L and EQ-VAS measure: Simple Shoulder Test measure: Single Assessment Numeric Evaluation (SANE) Score measure: Survivorship measure: Complications measure: Constant Murley Score (CMS) measure: EQ-5D-5L and EQ-VAS measure: Simple Shoulder Test measure: Single Assessment Numeric Evaluation (SANE) Score measure: Range of Motion sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hoag Orthopedic Institute city: Irvine state: California zip: 92618 country: United States lat: 33.66946 lon: -117.82311 facility: Atlantis Orthopaedics city: Lake Worth state: Florida zip: 33463 country: United States lat: 26.61708 lon: -80.07231 facility: Boston Sports & Shoulder Center city: Waltham state: Massachusetts zip: 02451 country: United States lat: 42.37649 lon: -71.23561 facility: Trinity Health Grand Rapids city: Grand Rapids state: Michigan zip: 49503 country: United States lat: 42.96336 lon: -85.66809 facility: Missouri Orthopaedic Institute (MOI) city: Columbia state: Missouri zip: 65201 country: United States lat: 38.95171 lon: -92.33407 facility: Lindner Research Center city: Cincinnati state: Ohio zip: 45219 country: United States lat: 39.12713 lon: -84.51435 facility: Cleveland Clinic city: Cleveland state: Ohio zip: 44195 country: United States lat: 41.4995 lon: -81.69541 facility: Slocum Center for Orthpaedics and Sports Medicine city: Eugene state: Oregon zip: 97401 country: United States lat: 44.05207 lon: -123.08675 facility: Rothman Orthopaedics Institute city: Philadelphia state: Pennsylvania zip: 19107 country: United States lat: 39.95233 lon: -75.16379 facility: TOSH- The Orthopedic Specialty Hospital city: Murray state: Utah zip: 84107 country: United States lat: 40.66689 lon: -111.88799 facility: University of Utah city: Salt Lake City state: Utah zip: 84108 country: United States lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06323967 id: 231981 briefTitle: Growing Strong Study of Unconditional Cash Transfers Plus Peer Support for Families With Babies in Homeless Shelters overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-03 date: 2027-03 date: 2024-03-21 date: 2024-03-21 name: Vanderbilt University class: OTHER name: Women in Need (Win) name: The Samuels Group name: New York City Center for Innovation through Data Intelligence (CIDI) briefSummary: The Growing Strong program tests a novel approach to helping families with young children living in homeless shelters, namely offering guaranteed, unconditional cash gifts that families can use as they wish plus voluntary peer support. The assumption behind this approach is that families know best how to allocate resources to meet their own individual needs. While there are a number of Direct Cash Transfer studies taking place around the country, the investigator(s) are unaware of any that have tested the relationship of receiving cash on homelessness among families specifically. To be eligible to participate in the study, families must reside in a homeless shelter and have at least one child under two years of age living with them in shelter. The investigator(s) have tied eligibility to the age of the youngest child in the household because rates of shelter use are highest among this population and because the costs associated with young children increase such families' financial burdens.

A total of 200 families will be enrolled in the study. One hundred families in the active intervention group will receive $1,500 per month ("substantial cash") for 24 months ($18,000 annually) and may also elect to receive peer support services. One hundred families in the active comparison group will receive $50 per month ("nominal cash") for 24 months ($600 annually) and will not have access to the peer support services. A third, passive comparison group will receive usual care within the homeless shelter system in the same metropolitan area (New York City) as participants in both cash gift groups. This group of families will be followed only in administrative records.

The main research questions are: does providing substantial, unconditional cash transfers plus access to voluntary peer support services over 24 months a) reduce the length of time in shelter for families with young children and/or b) improve other aspects of family and child well-being relative to providing nominal cash transfers alone or usual care. conditions: Time to Shelter Exit conditions: Family Well-being conditions: Child Well-being studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel assignment to 1) active treatment and 2) active comparison. A third, passive comparison group will be constructed and followed anonymously via administrative records. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participants will be blind to condition at the baseline assessment but will be unmasked immediately afterwards (they will receive debit cards and learn whether they are eligible for peer support). At baseline, interviewers will likely be aware of study conditions because they will interview respondents at shelters and shelter is associated with condition. At subsequent assessments interviewers will remain blind to study condition to the extent possible, but may well learn the condition from respondents, especially those who complete qualitative interviews. Win staff who provide usual care to both groups will be blind to the study condition. Participants in the passive comparison group will be unaware of the study. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Large unconditional cash transfers plus voluntary peer support. name: Nominal cash transfers name: Passive comparison group measure: Time to shelter exit measure: Housing: Total time in shelter* measure: Housing: Housing Stability measure: Target Child Development: Child Behavior Problems* measure: Target Child Development: Child Prosocial Behavior* measure: Target Child Development: Child Verbal Development measure: Parenting: Chaos in the Home* measure: Parenting: Early Learning Activities with Target Child* measure: Parenting: Target-Child-Focused Expenditure Index measure: Parenting: Household Routines measure: Parenting: Parenting Stress measure: Family Separation: Separation of Parent and Target Child (Cumulative at any time point)* measure: Family Separation: Indicated Investigations, Preventive services, or Child Placement of Target Child by Child Protective Services (No/Yes) measure: Adult Well-Being: Adult Psychological Distress* measure: Adult Well-Being: Adult Alcohol or Drug Abuse measure: Adult Well-Being: Hope measure: Domestic Violence: Adult Domestic Violence* measure: Financial Well-Being: Food Insecurity* measure: Financial Well-Being: Adult Economic Stress measure: Financial Well-Being: Financial Well-Being as Measured by the Consumer Financial Protection Bureau Financial Well-Being Scale measure: Financial Well-Being: Financial Hardship as Measured by the Urban Institute Well-Being and Basic Needs Survey measure: Employment: Income from Employment in Most Recent Period* measure: Employment: Adult Work for Pay measure: Health Care: Family Use of Emergency Medical Care or Hospitalization (Cumulative at any point)* measure: Health Care: Proportion of Target Child Immunizations Recommended by Age by the American Academy of Pediatrics measure: Health Care: Proportion of Well-Child Visits by Target Child Recommended by Age by the American Academy of Pediatrics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Win NYC Shelter System city: New York state: New York zip: 10004 country: United States name: Kirsten Cafarella, B.A. role: CONTACT phone: 646-899-6943 email: kcafarella@winnyc.org name: Marybeth Shinn, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06323954 id: H24110 briefTitle: tVNS During Motor Training in Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-05-31 date: 2026-06-30 date: 2024-03-21 date: 2024-04-01 name: Georgia Institute of Technology class: OTHER name: University of Florida briefSummary: The goal of this study is to learn about the effect of applying transcutaneous vagus nerve stimulation (tVNS) during motor training on motor learning in older adults. The main question it aims to answer is whether applying tVNS after successful motor trials (post-success tVNS) will facilitate the rate of motor learning. Participants will be randomly assigned to tVNS or sham group and receive tVNS or sham, respectively, at the outer ear during finger control training sessions. Finger control performance will be tested before and after the training sessions without outer ear stimulation. conditions: Older Adults studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: tVNS stimulation name: Sham stimulation measure: Rate of error reduction sex: ALL minimumAge: 65 Years maximumAge: 84 Years stdAges: OLDER_ADULT facility: Human Neuromuscular Physiology Lab city: Atlanta state: Georgia zip: 30332 country: United States name: Minoru Shinohara, Ph.D. role: CONTACT phone: 404-894-1030 email: shinohara@gatech.edu name: Minoru Shinohara, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06323941 id: UV0003 briefTitle: Motor Imagery and Isometric Exercises on Pelvic Floor Sensorimotor Condition overallStatus: COMPLETED date: 2023-11-01 date: 2024-03-01 date: 2024-03-14 date: 2024-03-21 date: 2024-03-22 name: University of Valencia class: OTHER briefSummary: Mental practice (both in isolation and also in combination with real practice) has been shown to improve somatosensory and motor variables but so far no study has taken it into the study of women's health. Through the present study the investigators want to offer some interesting data regarding the effectiveness of mental practice combined with physical practice. conditions: Isometric Exercise conditions: Motor Imagery conditions: Women's Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Motor Imagery plus therapeutic exercise name: Therapeutic exercises measure: Skin conductance (for asessing electrodermal activity) measure: Algometry for assessing pressure pain thresholds (Pain sensitivity) measure: maximal pelvic floor muscle strength (measured in grams and with the phenix device) sex: FEMALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Ferran Cuenca Martínez city: Valencia zip: 46017 country: Spain lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06323928 id: 20297A id: 2023-508821-28-00 type: OTHER domain: EU Trial briefTitle: A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments acronym: PROCEED overallStatus: RECRUITING date: 2024-04-01 date: 2025-07-31 date: 2025-09-30 date: 2024-03-21 date: 2024-04-17 name: H. Lundbeck A/S class: INDUSTRY briefSummary: The purpose of this trial is to determine which doses of Lu AG09222 are recommended to help prevent migraines. People who join this trial have already tried 2 to 4 other available medications to prevent their migraines, but these medications have not helped them. conditions: Migraine studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 498 type: ESTIMATED name: Lu AG09222 name: Placebo measure: Change From Baseline in the Number of Monthly Migraine Days (MMDs) measure: Change From Baseline in MMDs measure: Percentage of Participants With ≥50% Reduction From Baseline in MMDs measure: Percentage of Participants With ≥75% Reduction From Baseline in MMDs measure: Change from Baseline in the Number of Monthly Headache Days measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs) measure: Number of Participants with Anti-drug Antibodies (ADA) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Accellacare of Charleston status: RECRUITING city: Mount Pleasant state: South Carolina zip: 29464 country: United States lat: 32.79407 lon: -79.86259 hasResults: False

 nctId: NCT06323915 id: 2020_03_C3M briefTitle: Comparative Study of 3 Multifocal Intraocular Lenses in Murcia acronym: C3M overallStatus: RECRUITING date: 2021-04-20 date: 2025-06-20 date: 2025-09-20 date: 2024-03-21 date: 2024-03-21 name: Cristalens Industrie class: INDUSTRY briefSummary: The goal of this clinical trial is to compare the performance of 3 intraocular lenses (IOLs): FineVision (comparator), ARTIS SYMBIOSE (study lenses), and Tecnis Synergy (comparator) through binocular distance-corrected defocus curve.

This main objective will be to show superiority of the ARTIS SYMBIOSE system through binocular distance-corrected defocus curve.

The patient population to be included is patient suffering from cataract who requires cataract surgery procedure that meet the inclusion and non-inclusion criteria and provide written informed consent.

Participants will attend a total of 5 study visits: 1 preoperative visit, 1 surgery visit and 3 postoperative visits. conditions: Cataract studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 84 type: ESTIMATED name: intraocular lens implantation in cataract surgery measure: defocus curve comparison sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vista Clinic Ircovision Murcia status: RECRUITING city: Murcia zip: 30008 country: Spain name: Juan Zapata role: CONTACT phone: +34 968 27 17 35 email: juanf.zapata.diaz@gmail.com lat: 37.98704 lon: -1.13004 hasResults: False

 nctId: NCT06323902 id: PT-CO39 briefTitle: Autologous Platelet-rich Plasma as a Treatment for Macular Holes overallStatus: COMPLETED date: 2022-10-25 date: 2023-06-08 date: 2024-02-29 date: 2024-03-21 date: 2024-03-21 name: Clinica Oftalmologica Paredes class: OTHER briefSummary: For a series of patients with full-thickness macular hole, an autologous plasma rich in growth factors was developed in the form of a clot and applied to the retinal defect. These patients were followed up for a period of one year, obtaining substantial improvement both anatomically and functionally. conditions: Macular Holes conditions: Macular Hole of Left Eye (Disorder) conditions: Macular Hole of Right Eye (Disorder) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 13 type: ACTUAL name: Pars plana vitrectomy, with or without epiretinal membrane peeling, plus PRGF membrane implantation measure: Macular hole closure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinica Ofalmologica Paredes city: Pasto state: Nariño zip: 520002 country: Colombia lat: 1.21361 lon: -77.28111 hasResults: False

 nctId: NCT06323889 id: LIMITFOOD2 briefTitle: Longitudinal Monitoring During Intermittent Fasting Protocols in Obese Adults acronym: LIMITFOOD2 overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-01 date: 2027-01 date: 2024-03-21 date: 2024-04-19 name: University of Zurich class: OTHER briefSummary: LIMITFOOD2 is a randomized clinical intervention study that investigates the effects of two different intermittent fasting protocols compared to a control group on the health of obese adults. A total of 90 participants will be randomized into three equally sized groups: a modified alternate day fasting, a time-restricted eating and a control group, receiving general weight-loss counseling. conditions: Intermittent Fasting conditions: Obesity conditions: Time Restricted Eating studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: Modified Alternate Day Fasting name: Time-Restricted Eating name: Weight-loss counseling measure: Fat Volume measure: Distribution of fat volume measure: Concentration of Leptin measure: Changes in Insulin Sensitivity measure: Changes in Fasting Lipids measure: Changes in Inflammatory Markers measure: Free triiodothyronine (fT3) measure: Correlation of longitudinally measured parameters measure: Serum Metabolomics measure: Genetic Analysis measure: LDL Particle Size measure: Fecal Microbiome sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Department of Endocrinology, Diabetology and Clinical Nutrition city: Zürich zip: 8091 country: Switzerland lat: 47.36667 lon: 8.54999 hasResults: False

 nctId: NCT06323876 id: HSR301252 id: R01HL171918 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL171918 briefTitle: The Role of Quantitative CT and Radiomic Biomarkers for Precision Medicine in Pulmonary Fibrosis overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-05 date: 2029-05 date: 2024-03-21 date: 2024-03-21 name: University of Virginia class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: This observational study involves obtaining 2 chest CT scans; a historical baseline CT within ±1 year of enrollment into PRECISIONS, and a follow-up CT (either historical or prospective) 12 months ± 180 days after the baseline CT. Many IPF patients will have a CT scan every 12 months for disease monitoring and cancer screening. Participants will have the option to share historical CTs only or they can choose to have a research CT done for the follow-up scan, if a scan for clinical purposes is not available. conditions: Idiopathic Pulmonary Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 160 type: ESTIMATED name: HRCT name: Blood Draw measure: Derivation of DTA in IPF only cases from the PFF-PR and its associations with disease severity and outcomes. measure: Determine whether known IPF-risk genetic variants are associated with DTA score. measure: Identify novel genetic variants that associate with DTA score progression. measure: Determine if DTA or any constituent radiomic features correlate with select plasma proteins. measure: Determine if DTA or any of constituent radiomic features correlate with transcriptomic measure: Determine the best combination of markers (DTA, proteins and transcriptome) for machine learning algorithms for AUC evaluation of ROCs on all 3 cohorts. measure: Determine associations of changes in DTA scores with 12-month changes in FVC and DLCO. measure: Determine associations of changes in DTA scores with drug treatment (i.e., antifibrotics) sex: ALL minimumAge: 40 Years maximumAge: 101 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06323863 id: N°4-RCB/EUDRACT briefTitle: Ultra-high Resolution CT: the End of Stapes Prosthesis Measurement Misestimation overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-12-01 date: 2024-03-21 date: 2024-03-21 name: Central Hospital, Nancy, France class: OTHER briefSummary: Actual CT scanners overestimate stapes piston size, and do not represent a valuable technique for their follow-up, especially in case of complication. Ultra-high resolution has not yet been evaluated in this setting. conditions: Otosclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 20 type: ESTIMATED name: stapedectomy name: ultra high resolution CT measure: length sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Nancy city: Nancy zip: 54000 country: France name: romain gillet, md role: CONTACT phone: 00383851811 email: r.gillet@chru-nancy.fr lat: 48.68439 lon: 6.18496 hasResults: False

 nctId: NCT06323850 id: HM20028878 briefTitle: Improving Access to Community-Based Occupations Via a Rideshare Training Program overallStatus: RECRUITING date: 2024-05-15 date: 2025-02 date: 2025-02 date: 2024-03-21 date: 2024-04-04 name: Virginia Commonwealth University class: OTHER name: Organization for Autism Research briefSummary: Community mobility is critical for living independently and engaging in one's community. It is especially important for people in their early adult years, as this is often a time of transition to employment and living independently. Community mobility can be particularly challenging for adults with Autism Spectrum Disorders (ASD) (henceforth referred to as autistic adults based on the preferred identity-first language of our autistic partners). Some autistic adults are unable to meet the demands of driving. Public transportation is an option for autistic adults; and autistic adults are more likely to use public transportation than their non-autistic counterparts. However, using public transportation may be just as challenging as driving for the autistic population. Rideshare (also called ride-hailing) is a relatively new form of transportation in which passengers get from point A to point B in private vehicles driven by their owners. A digital app, usually accessed on a smartphone, matches passengers and drivers, coordinates routes using a GPS system, and facilitates payment through a linked financial account. Rideshare has the potential to address many of the issues autistic adults have accessing the community. It is faster and more direct than the public train or bus, there is limited social interaction required, and rides can be scheduled at any time. Despite it's potential to increase transportation in autistic adults, there are no evidence-based training programs to support Rideshare use in this population. conditions: Autism studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: A hybrid type-2 effectiveness-implementation randomized wait-list control design . The experimental group will receive the intervention first, while the waitlist group receives no intervention (Phase 1). After the 2-month intervention period, the waitlist group will receive the intervention, while the experimental group participates in a 2-month follow-up (Phase 2). During phase three, the waitlist group will participate in the 2-month follow up. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 12 type: ESTIMATED name: Intervention Phase name: Virtual Training Sessions name: Ride-Along Training Sessions measure: Evaluate the intervention by conducting an effectiveness-implementation waitlist-controlled trial using our Safe Rideshare Program (SRP) , evaluate autistic adults participating in the SRP intervention find the intervention acceptable? measure: Evaluate if the trainers conducting the SRP intervention find the intervention to be appropriate measure: Autistic adults who have participated in the SRP program display greater independence in using Rideshare compared to autistic adults who did not participate in the SRP program (wait-list group) measure: Autistic adults who have participated in the SRP program display greater safety in using Rideshare compared to autistic adults who did not participate in the SRP program (wait-list group)? measure: In the wait-list group, is there a change in community engagement, social participation, and employment from the waitlist phase (no intervention) to the 2-month follow-up period (after the intervention) measure: How do SRP participants use of Rideshare for community, social, and/or employment activities after the intervention sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Virginia Commonwealth University status: RECRUITING city: Richmond state: Virginia zip: 23298 country: United States name: Stacey Reynolds role: CONTACT phone: 410-241-2140 email: reynoldsse3@vcu.edu name: Alissa Brooke role: CONTACT phone: 804-827-0746 email: admolinelli@vcu.edu lat: 37.55376 lon: -77.46026 hasResults: False

 nctId: NCT06323837 id: 20383 briefTitle: Mirtazapine for the Treatment of Methamphetamine Use in Opioid Use Disorder Patients Receiving Medication Assisted Treatment acronym: MIRROM overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-04-01 date: 2024-03-21 date: 2024-03-21 name: Washington State University class: OTHER briefSummary: This project will evaluate the ability of Mirtazapine (MZP), a pharmacologically unique medication with a growing body of evidence to support its efficacy and safety for the treatment of methamphetamine (MA) use among medication for opioid use disorder (MOUD) patients, to significantly decrease MA use and related health-impairing behaviors. MZP has already successfully been used in the treatment of methamphetamine (detailed further below and in the Appendices).

The investigators hypothesize that those assigned to the MZP plus treatment as usual (TAU) MZP+TAU arm will demonstrate significantly increased rates of biochemically verified abstinence from MA and other substances of abuse and experience improvements in health impairing behaviors relative to the placebo (PLO)+TAU arm across the 10-week treatment and follow-up periods. conditions: Stimulant Use Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Mirtazapine name: Placebo measure: Urinanalysis Verified Increased Days of MA Abstinence measure: Actigraphy Verified Improved Sleep Patterns measure: Self Reported Quantity of Adverse Events measure: Urinanalysis Verified Increased Days of Abstinence from Other Substances sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06323824 id: 2000033271 id: CTN-0131 type: OTHER domain: Clinical Trials Network id: 5UG1DA015831-21 type: NIH link: https://reporter.nih.gov/quickSearch/5UG1DA015831-21 briefTitle: Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment. overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-12 date: 2029-05 date: 2024-03-21 date: 2024-03-21 name: Yale University class: OTHER name: National Institutes of Health (NIH) name: National Institute on Drug Abuse (NIDA) name: The Emmes Company, LLC name: University of California, San Francisco name: Boston Medical Center (BMC) name: Hennepin Healthcare Research Institute name: Alameda Health System name: Marshall Health name: Kaiser Permanente briefSummary: The purpose of this clinical trial is to compare the effectiveness of office-based methadone with pharmacy administration and/or dispensing to office-based buprenorphine for the treatment of opioid use disorder. This study will also examine factors influencing the implementation of office-based methadone. conditions: Opioid Use Disorder studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The comparative effectiveness of two strategies to address retention in medication for opioid use disorder (MOUD) treatment will be tested over a 168-day period. Behavioral treatments offered to patients are designed to be similar across the two medication conditions.

Office-based methadone where the clinician prescribes methadone and oral methadone is administered and/or dispensed at a pharmacy. Providers and Randomized Control Trial (RCT) participants will have flexibility to use behavioral and pharmacological services as clinically indicated.

Office-based buprenorphine (BUP) where the clinician prescribes BUP formulations that are dispensed at a pharmacy or administered in the office (e.g., extended-release formulations). Providers and RCT participants will have flexibility to use behavioral and pharmacological services as clinically indicated. primaryPurpose: TREATMENT masking: NONE count: 600 type: ESTIMATED name: Methadone name: Buprenorphine (BUP) measure: Number of days of continuous treatment with study site clinician-prescribed methadone or buprenorphine, as randomized, during the 168 days post-randomization among RCT participants. measure: Number of self-reported days in any FDA-approved formulation of MOUD treatment (e.g., buprenorphine, methadone or naltrexone) during the 168 days post-randomization. measure: Number of self-reported days in formal OUD treatment, according to American Society of Addiction Medicine (ASAM) levels of care 1-4, during the 168 days post-randomization. measure: Number of days prescribed any FDA-approved MOUD formulation during the 168 days post-randomization. measure: Number of days of self-reported non-prescribed opioid use per month. measure: Number of days of self-reported non-prescribed stimulant use per month. measure: Number of days of self-reported non-prescribed benzodiazepine use per month. measure: Urine toxicology measure: Participant satisfaction with MOUD measure: Total number of self-reported overdose events per total number of participant days at risk. measure: Total number of self-reported injection drug use related events per total number of participant days at risk. measure: Pain measured using PEG-3: "Pain average," "interference with Enjoyment of life," and "interference with General activity." measure: Number of self-reported days with acute care utilization (ED or hospitalization) events during the 168 days post-randomization per month. sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06323811 id: COPE CMR briefTitle: Comparison of Free-breathing 3D Quantitative Perfusion in Patients With MINOCA and MINOCA-mimics acronym: COPE-CMR overallStatus: RECRUITING date: 2023-06-15 date: 2025-06-30 date: 2025-12-31 date: 2024-03-21 date: 2024-03-21 name: University of Zurich class: OTHER name: ETH Zurich briefSummary: This clinical study examines patients presenting with acute myocardial infarction and no significant coronary artery disease on coronary angiography (MINOCA) and patients with MINOCA-mimics with advanced CMR.

The present study aims to:

* assess the microvascular function with a novel quantitative 3D myocardial perfusion imaging approach in the acute phase and post-convalescence
* refine the role and diagnostic potential of advanced quantitative CMR imaging
* assess the potential prognostic significance of microvascular dysfunction and epicardial adipose tissue on cardiovascular outcomes

Participants will undergo advanced CMR imaging in the acute setting (within 10 days after event) and post convalescence (after 3 months). conditions: Myocardial Infarction With Non-Obstructive Coronary Artery conditions: Myocarditis Acute conditions: Takotsubo Cardiomyopathy conditions: Spontaneous Coronary Artery Dissection conditions: Non ST Elevation Myocardial Infarction studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 5 groups of patients (MINOCA, myocarditis, Takotsubo cardiomyopathy, SCAD, NSTEMI) will undergo CMR with 3D perfusion in the acute setting (within 10 days after the event) and post convalescence (after 3 months) primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: INVESTIGATOR count: 75 type: ESTIMATED name: CMR measure: Myocardial perfusion reserve index measure: epicardial adipose tissue (EAT) measure: cardiovascular events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Zurich status: RECRUITING city: Zürich zip: 8091 country: Switzerland name: Robert Manka role: CONTACT lat: 47.36667 lon: 8.54999 hasResults: False

 nctId: NCT06323798 id: 2024PI035 briefTitle: Diffusion Weighted MRI Enables Differential Diagnosis Between Pyocele and Mucocele overallStatus: NOT_YET_RECRUITING date: 2024-04-28 date: 2024-07-28 date: 2024-12-28 date: 2024-03-21 date: 2024-03-21 name: Central Hospital, Nancy, France class: OTHER briefSummary: Diffusion MRI should allow for differentation of pus and simple retention in the paranasal sinuses, but this remained to be determined conditions: Pyocele; Sinus studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 20 type: ESTIMATED name: MRI measure: apparent diffusion coefficient sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06323785 id: 2022-D0067 briefTitle: Whole-body Hyperthermia for Depression overallStatus: RECRUITING date: 2024-04-30 date: 2026-03-01 date: 2026-03-01 date: 2024-03-21 date: 2024-04-24 name: University of Zurich class: OTHER briefSummary: The goal of this clinical trial is to test the efficacy of whole-body hyperthermia in major depression. The main question it aims to answer is:

• Does whole-body hyperthermia alleviate symptoms of depression?

Participants will be randomised to sham or active whole-body hyperthermia. The study will last 6 weeks during which five visits will take place. Depression will be measured repeatedly and biological mechanisms will be investigated. conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Active whole-body hyperthermia name: Sham whole-body hyperthermia measure: Hamilton Rating Scale for Depression (HAMD-17; minimum: 0, maximum: 68, higher scores indicate higher depression) measure: Beck Depression Inventory (BDI; minimum: 0, maximum: 63; higher scores indicate higher depression) measure: Medical Outcomes Study 36-item short-form health survey (MOS-SF; minimum: 0, maximum: 100, higher scores indicate better health status) measure: Hamilton Rating Scale for Depression (HAMD-17; minimum: 0, maximum: 68, higher scores indicate higher depression) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Zurich, Institute of Psychology status: RECRUITING city: Zurich zip: 8050 country: Switzerland name: Susanne Fischer, PhD role: CONTACT phone: +41446357460 email: s.fischer@psychologie.uzh.ch lat: 47.36667 lon: 8.54999 hasResults: False

 nctId: NCT06323772 id: RDC-RP-01 briefTitle: Natural History Study in Patients With PDE6A-, PDE6B- and RHO-linked Retinitis Pigmentosa overallStatus: RECRUITING date: 2023-11-17 date: 2027-03 date: 2027-03 date: 2024-03-21 date: 2024-03-21 name: University Hospital Tuebingen class: OTHER briefSummary: The aim of the study is to apply a novel clinical investigation protocol in patients with Phosphodiesterase 6A (PDE6A), PDE6B and Rhodopsin (RHO)-based retinitis pigmentosa. This novel, multimodal clinical examination protocol describes and correlates structural, functional and metabolic aspects during natural disease development.

Test-retest variability of new measurements as well as correlations of the structural, functional, and metabolic changes will be defined to be able to define well-suited readouts for safety and efficacy of future treatment developments before they reach the clinical phase. conditions: Retinitis Pigmentosa studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Optical coherence tomography (OCT) measure: Fundus autofluorescence imaging measure: Wide-field fundus photography measure: Adaptive optics imaging measure: V1 morphology (MRI) measure: Diffusion Tensor Imaging (DTI) measure: flavoprotein fluorescence (FPF) measure: Retinal oxymetry measure: Local dark adapted adaptation curves measure: best corrected visual acuity (BCVA) measure: Static cone perimetry and dark adapted perimetry measure: chromatic pupil campimetry (CPC) measure: electroretinogram (ERG) measure: Virtual reality (VR) functional test sex: ALL minimumAge: 5 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Ophthalmic Research, University Tübingen status: RECRUITING city: Tübingen state: Baden-Württemberg zip: 72076 country: Germany name: Katarina Stingl, Prof role: CONTACT phone: 070712988088 email: katarina.stingl@med.uni-tuebingen.de lat: 48.52266 lon: 9.05222 hasResults: False

 nctId: NCT06323759 id: 2022-14 briefTitle: Perinatal EDucation: Pedagogical Strategy and Facilitators for the PROMotion of BreastFeeding acronym: PED-PROM-BF overallStatus: COMPLETED date: 2023-02-06 date: 2024-03-01 date: 2024-03-01 date: 2024-03-21 date: 2024-03-21 name: Lépine Alexandra class: OTHER briefSummary: Breastfeeding up to 6 months of a child's life, for its benefits to mother and child, has become a global public health goal. However, there is a disparity in the prevalence of breastfeeding (BF) in different regions of the world. According to French perinatal surveys, the rate of BF at birth decreased significantly between 2010 and 2016. Even if that figure remains stable according to the last perinatal survey in 2021, it decreases sharply, to 34.4%, at 2 months.While many plans at the national level advocate for BF, it is rare to see an action plan or an education intervention for women and couples aimed at promoting BF. However, women's needs to educate about BF and the need for professionals to reflect on their practices are highlighted by numerous perinatal surveys. It should be noted that despite the importance given to the promotion of BF found in all National Nutrition and Health Programs, none of them provide pedagogical means or an education program to achieve the objectives set. At present, in France, there is no breastfeeding education program and professionals accompany women by implementing experimental actions without considering the complexity of the promotional dimension (producing a behavioral change) and the educational dimension (understanding the pedagogy of the proposed actions) conditions: Breast Feeding studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: This intervention is based on a pedagogical engineering that proposes a favorable learning environment more adapted than the courses already offered in preparing for parenthood and promoting breastfeeding primaryPurpose: OTHER masking: NONE count: 128 type: ACTUAL name: educational intervention measure: To find out the contribution of educational engineering to the choice and continuation of breastfeeding from the point of view of women until 4 months after the birth of the child. measure: To explain contexts and generative mechanisms of pedagogical design that influence breastfeeding management up to 4 months afther birth. measure: To explain interactions between existing contexts, generative mechanisms and effects on women's breastfeeding management skills. measure: To determine contexts and generative mechanisms of pedagogical design that influence women's knowledge of breastfeeding up to 4 months afther birth. measure: To evaluate the level of satisfaction about the educational intervention among nursing mothers. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Université Sorbonne Paris Nord - Laboratoire d'Educations et Promotion de la Santé - UR 3412 city: Bobigny zip: 93017 country: France lat: 48.9 lon: 2.45 hasResults: False

 nctId: NCT06323746 id: HR-EEG-CSAR briefTitle: Exploring Heart Rate Variability, EEG Pattern, and Corticomuscular Coherence After Cervical Sagittal Alignment Restoration overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-12 date: 2024-03-21 date: 2024-03-21 name: University of Sharjah class: OTHER briefSummary: The goal of this Randomized clinical trial is to learn about how fixing neck curvature and head posture right away affects heart rate, brainwaves, and muscle coordination in college athletes. The main question it aims to answer:

- Whether forward head posture (FHP) may play a crucial role in affecting heart rate variability, brainwaves, and muscle coordination. conditions: Cervical Lordosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Permuted block randomization to ensure an equal number of allocations in each of the two groups (intervention and wait list group). Each random block will be stored in opaque sealed envelopes consecutively numbered with a third researcher. Once each participant officially joins the study the researcher will open the subsequent envelop. whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Denneroll cervical traction orthodontic measure: Cervical Sagittal Alignment Radiographs measure: Cervical Sagittal Alignment Radiographs measure: Heart rate Variability (HRV) physiological parameter measure: Corticomuscular Coherence sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: University of Sharjah city: Sharjah zip: 0000 country: United Arab Emirates name: Ibrahim Mostafa Abuamr, professor role: CONTACT email: iabuamr@sharjah.ac.ae name: Shima Zadeh, Research Assistant role: SUB_INVESTIGATOR name: Ibrahim Mostafa Abuamr, Professor role: PRINCIPAL_INVESTIGATOR lat: 25.33737 lon: 55.41206 hasResults: False

 nctId: NCT06323733 id: 2CAPA briefTitle: Exercise Intervention for Patients With Cancer Cachexia: Effects of a 12-week Program and One-year Follow-up. acronym: 2CAPA overallStatus: ENROLLING_BY_INVITATION date: 2024-01-01 date: 2026-01 date: 2026-01 date: 2024-03-21 date: 2024-03-21 name: Peyrachon Romane class: OTHER briefSummary: The prevalence of cancer with cachexia is rising sharply. More than 80% of digestive cancer patients are affected by cancer cachexia. Cachexia leads to weight loss, and reduces quality of life (QoL), cancer treatment response and survival. Exercise could counteract the deleterious effects of cachexia. The 2CAPA study aims to assess the effectiveness of a 12-week exercise program on various symptoms associated with cancer cachexia, including Health-Related QoL (HRQoL), fatigue, appetite, body composition, physical fitness, and physical activity levels. Additionally, it seeks to examine compliance with the exercise program, identify barriers to regular exercise and determine how compliance influences physical and psychological effects. Furthermore, this study aims to determine the maintenance of physical activity levels and the effects post-program for one year follow-up on cachexia-related symptoms.

Methods: This study will include 31 cancer patients with cachexia. Participants will receive a supervised exercise program lasting 12-weeks with two sessions per week combining endurance and resistance training. Outcomes include HRQoL, fatigue, appetite, anthropometric parameters, physical performances, and physical activity levels at baseline, at the end of the 12-week exercise program, and at 3-, 6- and 12- months post-intervention. conditions: Cachexia-Anorexia Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 31 type: ESTIMATED name: Exercise Intervention measure: Health-Related Quality of Life measure: Body weight measure: Body mass index measure: Lean mass measure: Fat mass measure: Aerobic fitness measure: Muscular strength of the lower limbs measure: Handgrip strength measure: Static balance ability measure: Appetite measure: Cancer-related Fatigue measure: Physical Activity and Sedentary Levels measure: Stages of change for exercise measure: Exercise beliefs measure: Compliance to exercise intervention measure: Reasons for absence measure: Timing of absences measure: Fidelity to session duration measure: Fidelity to session intensity measure: Reasons to modify exercise sessions measure: Incidence of Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SPORMED city: Rennes state: Bretagne zip: 35000 country: France lat: 48.11198 lon: -1.67429 hasResults: False

 nctId: NCT06323720 id: ONZ-2023-0442 briefTitle: Signs of Central Sensitization in Tension-type Headache acronym: CSTTH overallStatus: RECRUITING date: 2024-02-23 date: 2025-07 date: 2025-12 date: 2024-03-21 date: 2024-04-01 name: University Ghent class: OTHER briefSummary: The goal of this observational study is to assess the pain sensitivity in tension-type headache patients. The main question it aims to answer is:

- Are signs of central sensitization present in tension-type headache?

Participants will be asked to fill out baseline questionnaires and they will be assessed during 1 test moment (static and dynamic quantitative sensory testing).

Researchers will compare tension-type headache patients with healthy controls to see if signs of central sensitization are only present in the tension-type headache group. conditions: Tension-Type Headache studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 66 type: ESTIMATED name: Quantitative Sensory Testing measure: Pain sensitivity for heat stimuli measure: Pain sensitivity for cold stimuli measure: Pain sensitivity for electrical stimuli measure: Pain sensitivity for pressure measure: Function of the pain facilitating pathways measure: Function of the pain inhibiting pathways sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ghent University status: RECRUITING city: Ghent state: East-Flanders zip: 9000 country: Belgium name: Jessica Van Oosterwijck, Prof. role: CONTACT lat: 51.05 lon: 3.71667 hasResults: False

 nctId: NCT06323707 id: IMPACT briefTitle: The IMPACT Implementation-Effectiveness Trial acronym: IMPACT overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2027-03-15 date: 2027-03-15 date: 2024-03-21 date: 2024-03-21 name: McMaster University class: OTHER name: Canadian Cancer Society (CCS) name: Hamilton Health Sciences Corporation name: Niagara Health System briefSummary: More Canadians are surviving cancer, however, individuals with cancer live with side effects for years after treatments have ended. The physical and psychosocial benefits of regular physical activity (PA) during and after cancer treatment are well established. However, less than 30% of individuals with cancer meet current PA recommendations and PA levels decline significantly during treatment. PA services within the cancer institution to support well-being during treatment are not available for survivors across Ontario. Strategies are needed within cancer centres to close the gap between the evidence and clinical practice.

What is the purpose? To evaluate the effectiveness of a novel exercise and education strategy for individuals with cancer during treatment.

What are we proposing to do? This project includes two parts. In Part 1 participants will be put into one of three groups. Group 1 (Exercise \& self-management) will include eight sessions of supervised, institution-based exercise and self-management education. Group 2 (self-management only) will include eight virtual self-management education sessions with an exercise professional. Group 3 will receive usual care (i.e., no intervention).

In Part 2 participants who attended less than 75% of their sessions will be asked to complete an interview on the barriers to continuing with the study during cancer treatment.

Why is this work important? Findings from this trial will inform the way PA services are provided within cancer institutions across Ontario. This novel strategy incorporates both institution-based and home-based exercise strategies during treatment and highlights the importance of individuals with cancer taking an active role in managing their condition during treatment. This can prevent future complications and decrease burden on the individual and the healthcare system. Results will inform future decisions on PA implementation strategies for cancer survivors with diverse needs across Ontario. conditions: Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 129 type: ESTIMATED name: Exercise name: Self-management e-module measure: Physical activity level measure: Physical activity level measure: Physical activity level measure: Quality of life measure: Quality of life measure: Quality of life measure: Level of exercise knowledge measure: Level of exercise knowledge measure: Level of exercise knowledge measure: Health status measure: Health status measure: Health status measure: Aerobic capacity measure: Aerobic capacity measure: Aerobic capacity measure: Cardiovascular outcomes - Blood pressure measure: Cardiovascular outcomes - Blood pressure measure: Cardiovascular outcomes - Blood pressure measure: Cardiovascular outcomes - Heart rate measure: Cardiovascular outcomes - Heart rate measure: Cardiovascular outcomes - Heart rate measure: Health care utilization measure: Health care utilization measure: Health care utilization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06323694 id: Attesa chirurgia-1 briefTitle: Quality of Life, Expectations, Thoughts and Fears of Patients on the Waiting List for Spinal Surgery acronym: chirurgia-1 overallStatus: COMPLETED date: 2022-05-15 date: 2024-01-25 date: 2024-02-16 date: 2024-03-21 date: 2024-04-16 name: Istituto Ortopedico Rizzoli class: OTHER name: University of Bologna briefSummary: The objective of this qualitative prospective observational study is to analyze the cognitive aspect, the emotional-behavioral state and the quality of life of patients during their stay on the waiting list for two categories of lumbar spinal surgery: arthrodesis and percutaneous vertebroplasty.

Hypothesis:

Considering the existing evidence that associates some peculiar psychological components (expectations, beliefs, fears, coping strategies) of the patient and the outcome of spinal surgery, as well as the importance that the waiting time for the intervention assumes for recovery post-operative, this study aims to investigate the subjective perception of one's condition and the waiting period prior to the expected spinal surgery.

This is a qualitative prospective observational study, monocentric with variable sample up to the level of saturation. The blind members are the staff who will listen to the recordings of the interviews and prepare the summary table of the same and the statistical researcher who will perform the analyzes.

The selection of the participants will be carried out in such a way as to ensure a heterogeneous sample in terms of age, sex and experience and as representative as possible of the population studied.

The number of participants in qualitative studies is usually determined by intentional sampling, based on the need to understand the full range of possible responses, to obtain the so-called data saturation.

All patients on the waiting lists of the Department of Spinal Surgery, for vertebral arthrodesis or percutaneous vertebroplasty are considered eligible.

The two types of surgery differ both in the surgical procedure and in the duration of the wait before surgery, which is 1-2 months for vertebroplasty and more than one year for spinal arthrodeses which are not of urgency or priority. conditions: Spinal Surgery studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 15 type: ACTUAL name: quality of life measure: Descriptive survey for vertebroplasty patients measure: Descriptive survey for spinal arthrodeses patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Ortopedico Rizzoli city: Bologna zip: 40136 country: Italy lat: 44.49381 lon: 11.33875 hasResults: False

 nctId: NCT06323681 id: Leading Study briefTitle: Pegylated Interferon α in Previously Interferon-treated CHB（Leading Study） overallStatus: RECRUITING date: 2024-02-04 date: 2027-02 date: 2027-08 date: 2024-03-21 date: 2024-03-21 name: Qing XIe class: OTHER briefSummary: Previous clinical practice and exploratory studies suggest that some patients who have not achieved functional cure in the first round of interferon therapy can achieve HBsAg clearance by interferon retreatment (intermittent therapy), which can reduce the occurrence of complications such as liver fibrosis, liver cirrhosis and liver cancer, and its clinical benefit is expected to be higher than that of NAs monotherapy.

This study is aimed to conduct a large-scale, multicenter, prospective study to confirm the benefit of peginterferon-based therapies in these populations. It expected to enroll about 2000 patients with chronic hepatitis B who have received prior interferon therapy and achieved a good response but without function cure, patients receive either interferon-based therapy or NAs monotherapy, according to their wishes and doctors' professional recommendations, with a ratio of 2:1 between the two groups, and all patients treated for 48 weeks. The HBsAg clearance rate before and after treatment, safety, etc. will be analyzed. conditions: Chronic Hepatitis b studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 2016 type: ESTIMATED name: Peginterferon α-2b based treatment group name: NAs monotherapy group measure: Proportion of patients with HBsAg below the lower limit of detection. measure: Decrease of HBV DNA levels at week 48 compared to baseline. measure: Proportion of patients with HBV DNA below the lower limit of detection. measure: Decrease of HBsAg levels at week 48 compared to baseline. measure: Proportion of patients with HBsAg seroconversion. measure: Proportion of patients with HBeAg below the lower limit of detection for patients with baseline HBeAg positive. measure: Proportion of patients with HBeAg seroconversion for patients with baseline HBeAg positive. measure: Serious adverse events. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine status: RECRUITING city: Shanghai state: Shanghai country: China name: Qing Xie, MD, PhD. role: CONTACT phone: 0086-021-64370045 phoneExt: 680403 email: xieqingrjh@163.com name: Honglian Gui, MD,PhD role: CONTACT phone: 0086-021-64370045 phoneExt: 680419 email: lillian_ghl@163.com name: Qing Xie, MD, PhD. role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06323668 id: H-23067693 briefTitle: Cardiac Implantable Electronic Device remOval Versus Full coUrse Medical Treatment acronym: CIEDOUT overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2028-06 date: 2038-01-31 date: 2024-03-21 date: 2024-03-21 name: Rigshospitalet, Denmark class: OTHER briefSummary: The CIEDOUT study is an open label randomized trial in patients with possible cardiac implantable electronic device (CIED) infection.

The hypothesis is that CIED removal + guideline antibiotic therapy is better than 6-weeks antibiotic therapy alone in preventing death or relapse of bacteremia in patients with bacteremia and possible CIED infection (not definite CIED infection).

The objective of this study is to test whether CIED removal + guideline antibiotic therapy is superior to 6-weeks antibiotic therapy alone in prevention of the composite endpoint of death or relapse bacteremia after 6 months of follow-up in patients with CIED and systemic infection but without definite CIED infection. conditions: Cardiac Implantable Electronic Device Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized open label trial primaryPurpose: TREATMENT masking: NONE maskingDescription: None (Open Label) count: 180 type: ESTIMATED name: Cardiac implantable electronic device extraction name: Empirical antibiotic therapy measure: Rate of death or relapse bacteremia measure: Days alive and out-of-hospital measure: Rate of death measure: Rate of readmission for any cause measure: Rate of cardiac implantable electronic device extraction measure: Rate of relapse bacteremia (the same microorganism) measure: Rate of bacteremia (all species) measure: Rate of definite CIED infection sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06323655 id: VP-VEC-162-1201 briefTitle: Evaluation of Next-Day Residual Effects of Tasimelteon Compared With Placebo and Active Control in Healthy Subjects overallStatus: COMPLETED date: 2018-07-19 date: 2018-08-28 date: 2018-08-28 date: 2024-03-21 date: 2024-03-21 name: Vanda Pharmaceuticals class: INDUSTRY briefSummary: The aim of this study is to investigate next-day residual effects of tasimelteon compared with placebo and active control in healthy subjects. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ACTUAL name: Tasimelteon name: Active Control Placebo name: Tasimelteon Placebo name: Active Control measure: Next-day effects on simulated driving performance as measured by changes in Standard Deviation of Lateral Position (SDLP) sex: ALL minimumAge: 21 Years maximumAge: 55 Years stdAges: ADULT facility: Vanda Investigational Site city: Laval state: Quebec country: Canada lat: 45.56995 lon: -73.692 hasResults: False

 nctId: NCT06323642 id: F.1-1/20ERB/SZABMU/941 briefTitle: Role of Probiotics as Adjunct Therapy Along With Standard Care in Decreasing Hospital Stay and Improving Symptoms in Pediatric Patients Admitted With Severe Pneumonia overallStatus: RECRUITING date: 2023-09-01 date: 2024-03-31 date: 2024-03-31 date: 2024-03-21 date: 2024-03-21 name: Shaheed Zulfiqar Ali Bhutto Medical University class: OTHER briefSummary: Probiotics as adjuvant therapy along with standard care can decrease hospital stay and improve symptoms (fever, tachypnea,cough) in pediatric patients admitted with severe pneumonia. conditions: Pneumonia conditions: Probiotics studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized control trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The patients and their parents/attendants will be kept blind to the fact that they are receiving either probiotic or placebo whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: probiotic containing Lactobacillus rhamnosus GG. name: placebo measure: Number of days in hospital measure: Number of days with cough, fever sex: ALL minimumAge: 6 Months maximumAge: 2 Years stdAges: CHILD facility: Pakistan Institute of Medical Sciences status: RECRUITING city: Islamabad state: Punjab zip: 12000 country: Pakistan name: Nighat Haider, FCPS role: CONTACT phone: 03212125768 email: nighathaider@hotmail.com name: rashiqa saadat, MBBS role: PRINCIPAL_INVESTIGATOR lat: 33.72148 lon: 73.04329 hasResults: False

 nctId: NCT06323629 id: STUDY006201 briefTitle: Effects of Recursive Self-feedback on Speech Production in Aphasia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-03 date: 2024-03-21 date: 2024-03-21 name: University of South Florida class: OTHER name: Center for Smart Use of Technologies to Assess Real-world Outcomes briefSummary: The goal of this clinical trial is to test the effects of recursive self-feedback procedures on spontaneous speech production in stroke survivors with impaired speech production (aphasia). The main question it aims to answer is:

• To what extent can stroke survivors with aphasia use their self-feedback alone to improve their spontaneous speech production?

Participants will be engaged in the following activities:

* They will perform language and cognitive tasks.
* Afterwards, they will receive treatments using tablets and headphones at no cost to them.
* The experimental treatments (recursive self-feedback procedures) entails responding to prompts, listening to playbacks of their speech response and attempt to minimize/correct the errors in the next attempt. This process will be repeated multiple times per prompt.
* The experimental treatments are two: an adaptive version that adapts the complexity of the treatment prompt and a non-adaptive version that does not adapt task complexity.
* Researchers will compare the experimental treatments to see if both have similar effects on improving spontaneous speech production. conditions: Aphasia conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Adaptive recursive self-feedback procedure name: Non-adaptive recursive self-feedback procedure measure: Speaking rate measure: Speech initiation latency in milliseconds sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06323616 id: 2023/2343 briefTitle: The Effect of Anesthesia Depth Monitoring on Emergence Delirium in Pediatrics overallStatus: RECRUITING date: 2024-03-25 date: 2024-08-01 date: 2024-09-01 date: 2024-03-21 date: 2024-03-21 name: Istanbul University class: OTHER briefSummary: Some changes in the patient's cognitive state are observed during the recovery period from general anesthesia. This period of behavioral dysregulation has been called emergence agitation (EA) and emergence delirium (ED). ED and EA occur in the early postoperative period (often within the first 30 minutes). The incidence of ED ranges from 10% to 80% in children and is described as a distressing clinical condition by 42% of pediatric anesthesiologists. Self-harm by the child increases the risk of delayed discharge and may increase the cost of medical care.

Sevoflurane is a widely used agent for the induction and maintenance of anesthesia, but its use is associated with the occurrence of ED in the pediatric population. Clinical findings are characterized by hallucinations, struggling, restlessness, crying, and disorientation.

In the literature, the Pediatric Anesthesia Rescue Delirium (PAED) Scale Score is used in the diagnosis of ED and EA. This score consists of 5 criteria (maximum score 20) scored using 0-4 point scales. These criteria; The child needs to make eye contact with the caregiver, the child's movements are purposeful, the child is aware of the environment, the child is restless/angry, the child cannot be consoled. While the sensitivity of ≥10 points for the diagnosis of ED is 64% and the specificity is 86%, the sensitivity of \>12 points for the diagnosis of ED is 100% and the specificity is 94.5%.

Monitoring intraoperative depth of anesthesia in the adult population has been recommended by the American Society of Anesthesiologists (ASA) due to its potential benefits such as faster recovery time and lower drug dosage, as well as prevention of adverse effects such as the incidence of hypotension. The use of anesthesia depth monitors used so far for children is controversial because brain development in children has not yet been completed and the calculation algorithms of these indices are based on adult EEG characteristics.

There are very few studies in the literature on the relationship between anesthesia depth monitoring and EA/ED in children, and further studies are needed. conditions: Anesthesia conditions: Emergence Delirium conditions: Anesthesia Awareness conditions: Behavior Child Problems conditions: Postoperative Delirium conditions: Postoperative Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, Single-Blind, Prospective, Interventional primaryPurpose: SCREENING masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 270 type: ESTIMATED name: MAC adjustment to PSI between 25 and 50 measure: ED/EA incidence measure: mYPAS measure: PSI <25 episode duration measure: PSI >50 episode duration measure: PSI <25 number of episodes measure: PSI >50 number of episodes measure: Suppresyon ratio measure: SEF95R measure: SEF95L measure: Mean blood pressure measure: Heart rate measure: SpO2 measure: Total amount of sevoflurane used measure: Total amount of remifentanil used measure: MAC measure: Waking up time measure: Pupil size measure: Anesthesia duration measure: Surgery duration measure: PHBQ measure: Ped-PADS measure: Time of discharge from hospital sex: ALL minimumAge: 2 Years maximumAge: 8 Years stdAges: CHILD facility: Istanbul University status: RECRUITING city: Istanbul country: Turkey name: Meltem Savran Karadeniz, Assoc. Prof. role: CONTACT phone: 009005334845563 email: mskaradeniz@gmail.com lat: 41.01384 lon: 28.94966 facility: Istanbul University status: RECRUITING city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06323603 id: 3-1 briefTitle: Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic overallStatus: RECRUITING date: 2023-06-30 date: 2024-06 date: 2024-09 date: 2024-03-21 date: 2024-03-25 name: Ricard Marcos class: OTHER name: Finnish Institute of Occupational Health briefSummary: The biomonitoring study aims to evaluate genotoxic damage and other parameters of exposure in different occupational exposed populations that work directly with different plastics. conditions: Occupational Exposure conditions: Genotoxicity conditions: Damage Dna studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 45 type: ESTIMATED name: Micro and nanoplastic measure: Characterization of macro and nanoplastics measure: Genotoxic evaluation by the Micronucleus assay measure: Genotoxic evaluation by the Comet assay measure: Cytokine release measure: Microbiota analysis from feces by MinIOn measure: Analyses of surrogate biomarkers sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Textile industry status: COMPLETED city: Helsinki country: Finland lat: 60.16952 lon: 24.93545 facility: Recycling company status: COMPLETED city: Alicante country: Spain lat: 38.34517 lon: -0.48149 facility: Textile Industry status: COMPLETED city: Alicante country: Spain lat: 38.34517 lon: -0.48149 facility: Control recruitment status: RECRUITING city: Barcelona country: Spain name: Susana Pastor role: CONTACT lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06323590 id: UAB 2372 id: UAB type: OTHER domain: UAB briefTitle: Refining the Role of Mid-induction Bone Marrow Biopsy in Acute Myeloid Leukemia: A Pilot Study overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-05 date: 2028-05 date: 2024-03-21 date: 2024-03-21 name: University of Alabama at Birmingham class: OTHER briefSummary: The purpose of the study is to observe the outcomes of patients with acute myeloid leukemia who do not receive an immediate second round of chemotherapy after undergoing a standard mid-induction bone marrow biopsy. conditions: Acute Myeloid Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: rates of complete remission sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Omer Jamy role: CONTACT phone: 205-934-2721 email: omerjamy@uabmc.edu name: Omer Jamy role: CONTACT phone: 2059342721 email: omerjamy@uabmc.edu name: Omer Jamy role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False

 nctId: NCT06323577 id: TUH rKA vs MA TKA briefTitle: Comparing Efficacy Between Restricted Kinematic Alignment vs Mechanical Alignment in Bilateral TKA overallStatus: RECRUITING date: 2024-03-14 date: 2026-05-31 date: 2026-05-31 date: 2024-03-21 date: 2024-03-21 name: Thammasat University Hospital class: OTHER briefSummary: The goal of this RCT is to investigate efficacy between restricted kinematic alignment and mechanical alignment TKA in simultaneous bilateral TKA patients.

The main question\[s\] it aims to answer are:

* Does rKA have better functional outcomes than MA in simultaneous bilateral TKA patients?
* Does rKA have lower pain score than MA in simultaneous bilateral TKA patients? Participants will undergo simultaneous bilateral TKA and randomized one side will use rKA and the other side will use MA. conditions: Osteoarthritis, Knee conditions: TKA studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Restricted kinematic alignment name: Mechanical alignment measure: Forgotten joint score measure: Modified WOMAC score measure: Range of motion measure: Pain score measure: Hip knee ankle angle measure: Complications measure: Incidence of soft tissue releasing sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thammasat University status: RECRUITING city: Khlong Luang state: Pathum Thani zip: 12120 country: Thailand name: Yot Tanariyakul, M.D. role: CONTACT phone: 663930257 email: y.tanariyakul@gmail.com name: Nattapol Tammachote, M.D. role: PRINCIPAL_INVESTIGATOR lat: 14.06467 lon: 100.64578 hasResults: False

 nctId: NCT06323564 id: 21C223 briefTitle: Exploring Emotional Intelligence and Cognitive Flexibility in Anorexia Nervosa and Parkinson's Disease. acronym: INTELLEGO overallStatus: RECRUITING date: 2023-01-13 date: 2024-08-13 date: 2025-01-13 date: 2024-03-21 date: 2024-03-21 name: Istituto Auxologico Italiano class: OTHER briefSummary: The main aim of this study is to demonstrate how disorders characterized by different types of "inflexibility", cognitive-affective type for Anorexia nervosa and motor one for Parkinson's disease, have an impact on how emotional stimuli are processed and on the transition within emotional states. conditions: Anorexia Nervosa conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Neuropsychological tests in PD name: Self-report questionnaires in PD name: International Affective Picture System (IAPS) name: Neuropsychological tests in AN name: Self-report questionnaires in AN name: Analysis of bio-humoral parameters measure: Change in International Affective Picture System (IAPS) measure: Change in self-report questionnaires - STAI measure: Change in self-report questionnaires - BDI measure: Change in Heart rate variability measure: Change in analysis of bio-humoral parameters sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano status: RECRUITING city: Oggebbio zip: 28824 country: Italy name: Riccardo Cremascoli, MD, PhD role: CONTACT lat: 45.99088 lon: 8.64663 hasResults: False

 nctId: NCT06323551 id: 2023/50 briefTitle: The Effect of Mother's Smell and Breast Milk Smell on Pain overallStatus: RECRUITING date: 2024-03-14 date: 2024-07-14 date: 2024-12-24 date: 2024-03-21 date: 2024-03-25 name: Tarsus University class: OTHER briefSummary: The research was planned as a randomized controlled study to investigate the effect of breast milk smell and mother's smell applied while heel blood was taken to term babies in the Mersin City EAH Neonatal Intensive Care Unit between October and December 2023, on acute pain and crying duration. During the heel prick procedure, which is routinely performed in the neonatal intensive care unit, no pharmacological/non-pharmacological method will be applied to the control group to reduce the baby's pain before, during and after the heel prick. The baby's pain score will be evaluated by the observing nurse according to the NIPS pain scale 5 minutes before, during and 5 minutes after the procedure.

In the study group that will be made to smell the mother's scent; The mother of each baby whose heel blood will be taken will be given a specially made cover made of 100% cotton yarn, sterilized the day before, and the mother will be asked to put the cover on her bare skin (on her bare skin) after the shower and to keep the cover on the mother's chest for one night (8 hours). It will be placed 15 cm away from the baby and smelled 5 minutes before and 5 minutes after the heel prick attempt. The baby's pain score will be evaluated by the observing nurse according to the NIPS pain scale 5 minutes before, during and 5 minutes after the procedure. conditions: Newborn; Vitality conditions: Pain conditions: Crying studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled primaryPurpose: OTHER masking: NONE count: 90 type: ESTIMATED name: Mother's Smell name: Mother's Breast Milk Smell measure: Neonatal Infant Pain Scale measure: criying time sex: ALL minimumAge: 1 Day maximumAge: 15 Days stdAges: CHILD facility: Tarsus State Hospital status: RECRUITING city: Mersin country: Turkey name: Atiye Karakul, Ass. Prof. role: CONTACT phone: 90(324) 600 00 33 phoneExt: 2231 email: atiyekarakul@gmail.com lat: 36.79526 lon: 34.61792 hasResults: False

 nctId: NCT06323538 id: 01 briefTitle: Cohort Study on Plant-based Diets (COPLANT Study) acronym: COPLANT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-03-31 date: 2047-03-31 date: 2024-03-21 date: 2024-03-22 name: German Federal Institute for Risk Assessment class: OTHER name: Max Rubner-Institut name: University of Bonn name: Research Institute for Plant-Based Nutrition name: University of Jena name: University of Regensburg name: Heidelberg University name: University of Vienna briefSummary: The Cohort on Plant-based Diets (COPLANT) study is a multi-centre cohort study that starts baseline recruitment from 2024 to 2027 with approximately 6,000 participants in Germany and Austria. The COPLANT study focuses on vegan (no animal products), vegetarian (no meat and fish, but dairy products and eggs), pescetarian (no meat, but fish) and omnivorous (mixed diet including all possible animal products) diets. The aim of the COPLANT study is to gain new insights on health benefits and risks as well as social, ecological and economic effects of different plant-based diets in comparison to a mixed diet. In addition to a detailed dietary survey using an app adapted to the needs of this study, the baseline examination includes measurements of body composition, bone health, cardiovascular risk factors, diabetes risk, contaminants and lifestyle. For the basic laboratory program, fasting blood, 24-hour urine collection and a stool sample are taken from all study participants. Furthermore, specific aspects of dietary behavior, physical activity and other lifestyle factors are collected via questionnaires. Follow-up studies are planned at intervals of 5, 10 and 20 years after the baseline visit. conditions: Dietary Exposure conditions: Diabetes Mellitus, Type 2 conditions: Cardiovascular Diseases conditions: Bone Loss conditions: Sustainability conditions: Exposure conditions: Obesity conditions: Vitamin Deficiency conditions: Mineral Deficiency studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 6000 type: ESTIMATED measure: Incidence of diabetes type 2 measure: Incidence of cardiovascular diseases measure: Incidence of cancer measure: Vitamin B12 measure: Holo-transcobalamine measure: Homocysteine measure: Methylmalonic acid measure: Vitamin B1 status measure: Vitamin B2 status measure: Vitamin B6 status measure: Vitamin C status measure: Vitamin D status measure: Vitamin E status measure: Iron measure: Ferritin measure: Transferrin measure: Zinc status measure: Selenium status measure: Iodine status measure: Blood pressure measure: Blood lipids measure: Fasting insulin measure: Fasting glucose measure: Glycated hemoglobin (HbA1c) measure: C-peptide measure: Osteocalcin measure: Ostase measure: Parathormone measure: N-terminal propeptide of type I procollagen (PINP) measure: C-terminal telopeptide of type I collagen (CTX) measure: Creatinine measure: Uric acid measure: Cytstatin C measure: Thyroid stimulating hormone (TSH) measure: Free triiodothyronine (fT3) measure: Free thyroxine (fT4) measure: Body fat measure: Skeletal muscle mass measure: Total Body Water measure: Energy intake measure: Nutrient intake measure: Intake of dietary supplements measure: Intake of medication measure: Heavy metals measure: Halogenated, polycyclic aromatic hydrocarbons (dioxins) measure: Mycotoxins measure: Per- and polyfluoroalkyl substances (PFAS) measure: Microbiome sex: ALL minimumAge: 18 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Vienna city: Vienna zip: 1090 country: Austria lat: 48.20849 lon: 16.37208 facility: Max Rubner-Institut city: Karlsruhe state: Baden-Württemberg zip: 76131 country: Germany name: Benedikt Merz, PhD role: CONTACT email: benedikt.merz@mri.bund.de lat: 49.00937 lon: 8.40444 facility: Friedrich-Schiller University city: Jena state: Thuringia zip: 07743 country: Germany name: Christine Dawczynski, PhD role: CONTACT phone: +49 3641 949656 email: christine.dawczynski@uni-jena.de lat: 50.92878 lon: 11.5899 facility: The German Federal Institut for Risk Assessment city: Berlin zip: 10589 country: Germany name: Cornelia Weikert, Prof role: CONTACT phone: +49 30 1841255000 email: Cornelia.Weikert@bfr.bund.de lat: 52.52437 lon: 13.41053 facility: University Bonn city: Bonn country: Germany name: Ute Nöthlings, Prof role: CONTACT email: noethlings@uni-bonn.de lat: 50.73438 lon: 7.09549 facility: Research Institute for Plant-Based Nutrition, Gießen city: Gießen zip: 35444 country: Germany name: Markus Keller, PhD role: CONTACT email: keller@ifpe-giessen.de lat: 50.58727 lon: 8.67554 facility: University Heidelberg city: Heidelberg zip: 69120 country: Germany name: Ina Danquah role: CONTACT email: ina.danquah@uni-heidelberg.de lat: 49.40768 lon: 8.69079 facility: University Regensburg city: Regensburg zip: 93053 country: Germany name: Michael Leitzmann, Prof role: CONTACT email: Michael.Leitzmann@klinik.uni-regensburg.de name: Beate Fischer role: CONTACT email: Beate.Fischer@klinik.uni-regensburg.de lat: 49.01513 lon: 12.10161 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-11-20 uploadDate: 2024-02-23T09:43 filename: Prot_000.pdf size: 1528917 hasResults: False

 nctId: NCT06323525 id: CHN-PLAGH-BT-083 briefTitle: TCR Reserved and Power3 Gene Knock-out Allogeneic CD19-targeting CAR-T Cell Therapy in r/r B Cell Lymphoma overallStatus: RECRUITING date: 2024-04-17 date: 2026-04-25 date: 2027-04-25 date: 2024-03-21 date: 2024-04-18 name: Chinese PLA General Hospital class: OTHER briefSummary: The safety and efficacy of the chimeric antigen receptor (CAR)-T, a CD19-targeting, TRAC and Power3 double genes deleted allogeneic CAR-T cell product, are undergoing rigorous evaluation in non-Hodgkin's lymphoma (NHL) subjects from our ATHENA trial (NCT06014073). Unexpectedly, expansion of the initial residual CD3-positive CAR T from products were measured in patients' peripheral blood (PB) without exception. Accompanying with host immune reconstitution and appearance of the detectable B cells, the CD3-positive allogenic CAR T cells exhibited a compelling amplification advantage over CD3-negative CAR T cells. The amplification of CD3-positive CAR T cell population dynamically suppressed host B cell recovery, and presumably surveilled the recurrence or progression of tumors, but did not induce typical Graft-versus-host-disease (GvHD). Additionally, a series of in vitro experiments illustrated that the HLA-mismatched fratricide between host T cells and TCR-reserved Power3-deleted allogenic CAR T cells was markedly slashed, which in combination with our observed clinical safety date supported the notion that only genomic deletion of Power3 gene in allo-CAR T cells is sufficient to overcome GvHD and host T cell-mediated rejection response.

In the ATHENA-2 study, our design is to preserve the expression of the TCR on T cells from healthy donors while selectively disabling the Power3 gene to prepare ATHENA-2 CAR T cells. This approach harnesses the tonic signaling of CAR T cells, resulting in enhanced persistence and improved response to treatment. The purpose of this study is to evaluate the safety and efficacy of ATHENA-2 in B-cell NHL. conditions: Non-hodgkin Lymphoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: TCR reserved and Power3 gene knock-out allogeneic CD19-targeting CAR-T cell (ATHENA-2 CAR-T) name: Fludarabine name: Cyclophosphamide measure: Phase 1: Incidence of adverse events (AEs) defined as DLT measure: Phase 1: Recommended phase 2 dose (RP2D) measure: Phase 2: 3-month objective response rate (ORR) measure: Phase 2: Complete response (CR) rate measure: Phase 2: Duration of Response (DOR) measure: Phase 2: Overall Survival (OS) measure: Phase 2: Progression Free Survival (PFS) measure: Phase 1 and phase 2: Pharmacokinetics: Level of ATHENA-2 CAR-positive T cells circulating in blood over time measure: Phase 1 and phase 2: Pharmacodynamics: Level of CD19+ cells in peripheral blood measure: Phase 1 and phase 2: Level of serum cytokines in peripheral blood measure: Phase 1: 3-month ORR measure: Phase 1: OS measure: Phase 1: PFS measure: Phase 2: Incidence of AEs measure: Phase 1: Level of donor-specific antibody (DSA) in blood. measure: Phase 1: Level of human anti-mouse antibodies (HAMA) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Biotherapeutic Department of Chinese PLA General Hospital status: RECRUITING city: Beijing state: Beijing zip: 100853 country: China name: Weidong Han, M.D role: CONTACT phone: +86-010-66937463 email: hanwdrsw@sina.com name: Qingming Yang, M.D role: SUB_INVESTIGATOR name: Yang Liu, M.D role: SUB_INVESTIGATOR name: Jinhong Shi, M.S role: SUB_INVESTIGATOR name: Chunmeng Wang, M.S role: SUB_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Biotherapeutic Department of Chinese PLA General Hospital status: RECRUITING city: Beijing country: China name: Weidong Han, Ph.D role: CONTACT phone: +86-010-55499341 email: hanwdrsw@sina.com lat: 39.9075 lon: 116.39723 facility: EdiGene Inc status: RECRUITING city: Beijing country: China name: Zixuan Pang, Ph.D role: CONTACT phone: 010-80733899 email: zxpang@edigene.com lat: 39.9075 lon: 116.39723 facility: School of Life Sciences, Peking University status: RECRUITING city: Beijing country: China name: Wensheng Wei, Ph.D role: CONTACT phone: 010-62757794 email: wswei@pku.edu.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06323512 id: Nanjing briefTitle: Pulmonary Arteyr Denervation for Heart Failure overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-11-01 date: 2025-12-30 date: 2024-03-21 date: 2024-04-24 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: Prolonged pulmonary venous congestion culminates in pulmonary hypertension, defined as a mean pulmonary arterial pressure \> 20 mmHg and pulmonary artery wedge pressure \>15 mmHg at rest, as determined by right heart catheterization. Pulmonary hypertension secondary to heart failure (PH-HF) is further stratified into isolated post-capillary pulmonary hypertension (Ipc-PH, pulmonary vascular resistance (PVR) is ≤2 Woods Unit) and combined pre- and post-capillary pulmonary hypertension (Cpc-PH, PVR \> 2 Woods Unit), the later reflecting additional pulmonary vascular constriction or remodeling in addition to passive PH. While medications tailored for World Health Organization defined Group I pulmonary arterial hypertension are not endorsed for PH-HF according to current guidelines, the coexistence of pulmonary hypertension exacerbates the severity of heart failure. Given the presence of pulmonary arterial vasoconstrictor and heightened sympathetic nervous activity in patients with heart failure, the PADN-5 study has demonstrated the safety and efficacy of pulmonary artery denervation (PADN) for patients with CpcPH, characterized by the improvements in left ventricular ejection fraction, cardiac output, clinical outcome, and reductions in left atrial pressure, pulmonary arterial pressure, and PVR. Our objective is to assess the feasibility, safety, and efficacy of PADN for patients with heart failure independent of left ventricular ejection fraction (HFrEF or HFpEF) without pulmonary hypertension (N=30, 15 with HFrEF and another 15 with HFpEF). conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Pulmonary artery denervation (PADN) measure: Left ventricular ejection fraction measure: Tricuspid annuls peak systolic excursion (TAPSE) measure: 6 minute walk distance changes measure: All-cause death measure: Rehospitalization measure: NT-proBNP measure: Superoxide dismutase (SOD) 3 measure: Plasma noradrenaline measure: All outcomes will be stratified by HFrEF and HFpEF sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06323499 id: UK Essen briefTitle: Outcome of Induced Atypical Atrial Flutter overallStatus: COMPLETED date: 2018-04-01 date: 2021-10-31 date: 2021-10-31 date: 2024-03-21 date: 2024-04-24 name: University Hospital, Essen class: OTHER briefSummary: Background: Atypical atrial flutter (AAF) is an increasingly relevant clinical problem. Despite advancements in mapping and ablation techniques, the general management of these patients remain challenging especially when mapping cannot be performed during ongoing arrhythmia. There are no data whether induction of AAF is a feasible approach in these cases.

Methods: The investigators retrospectively analyzed patients who underwent catheter ablation of AAF and compared procedural results between patients with ongoing tachycardia when starting the procedure and patients with induced AAF.

For this retrospective study, the investigators analyzed patients undergoing ablation of AAF between April 2018 and January 2021 that were identified from the ablation database at the West German Heart and Vascular Center, Essen. All patients were followed up in the outpatient clinic as part of the clinical standard routine or contacted by telephone to assess the occurrence of clinical recurrence of any arrhythmia. In case the documentation was not performed at the institution, relevant documents and ECGs were requested and reviewed.

This single-center cohort study was conducted at the University Hospital Essen, Germany, in accordance with the Declaration of Helsinki and its amendments and was approved by the institutional review board of the University of Essen (number 21-10341-BO). Written informed consent was obtained from all study participants.

The primary study endpoint was to evaluate the outcome of patients with induced AAF in comparison to patients with ongoing AAF when starting the procedure. Furthermore, the investigators analyzed the type of recurrence during follow-up as well as the occurrence and results of repeat ablations at the institution. The investigators also evaluated if the recurrent AAF form was the same or de-novo compared to the AAF during previous procedure. conditions: Tachyarrhythmia conditions: Atypical Atrial Flutter conditions: Induction of Arryhthmia conditions: Clinical Outcome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 76 type: ACTUAL name: Induction of atypical atrial flutter measure: Outcome of patients with induced AAF in comparison to patients with ongoing AAF when starting the procedure. measure: Type of recurrence during follow-up measure: Occurrence and results of repeat ablations at our institution sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Essen city: Essen state: Nordrhein-Westfalen zip: 45147 country: Germany lat: 51.45657 lon: 7.01228 hasResults: False

 nctId: NCT06323486 id: 23-015-B briefTitle: Accelerated Bilateral Sequential Theta Burst Stimulation in Older Adults With Treatment-resistant Depression acronym: CogniTReaD overallStatus: RECRUITING date: 2024-04-01 date: 2026-03-30 date: 2026-03-30 date: 2024-03-21 date: 2024-03-21 name: Ontario Shores Centre for Mental Health Sciences class: OTHER name: Sunnybrook Health Sciences Centre briefSummary: The CogniTReaD study is a pilot clinical trial that will compare the effects of active accelerated bilateral sequential theta burst stimulation (absTBS) and sham or inactive treatment. The goal is to see if absTBS can help older adults with treatment-resistant depression (TRD) by looking at dual-task cost and mood, as well as other cognitive functions, anxiety levels, quality of life, and physical performance, while also checking for any treatment side effects. The study will recruit participants who will receive different study treatments in a specific order. The study will be double-blinded, meaning neither the participants nor the researchers will know who is receiving which treatment. The study will include people who are 50 years old or older and diagnosed with treatment-resistant depression with at least a moderate severity of depression. This study seeks to discover if absTBS can modify a dementia risk marker (i.e., dual-task cost and depression) in older patients with TRD, and to determine the effect size for larger investigations in the future. conditions: Depressive Disorder, Treatment-Resistant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: We will enroll patients who are willing to be randomized to either the accelerated bilateral sequential theta burst stimulation (absTBS)-sham or sham-absTBS treatment sequence arms. In the absTBS-sham sequence, participants shall receive the active absTBS treatment at Week 1, followed by sham treatment at Week 3, while in the sham-absTBS sequence, participants shall receive sham treatment at Week 1, followed by the active absTBS treatment at Week 3. The primary rationale for employing this sequential treatment strategy for both arms in this trial is to ensure that those assigned to the sham-absTBS group do not have to wait for longer periods to begin receiving the active absTBS therapy and to maintain blinding continuity. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: We shall perform a double-blinding system where the participants, study investigators, transcranial magnetic stimulation (TMS) technicians (those who operate and administer TMS procedures), and research assistants (outcome assessors) are masked to the assignment of the enrolled participants. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: active accelerated bilateral sequential theta burst stimulation and sham treatment measure: Change in Dual-task Cost measure: Change in Hamilton Depression Rating Scale 17 (HAMD-17) score measure: Adverse events (AE) measure: Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) score measure: Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) plus modalities score measure: Change in Trail Making A (TMT-A) score measure: Change in Trail Making B (TMT-B) score measure: Change in Digit Symbol Substitution Test (DSST) score measure: Change in Digit Span Forward (DSF) score measure: Change in Digit Span Backward (DSB) score measure: Change in Category Verbal Fluency (CVF) score measure: Change in Montreal Cognitive Assessment (MoCA) score measure: Change in Colour Word Interference Test (CWIT) score measure: Change in Patient Health Questionnaire-9 (PHQ-9) score measure: Change in Geriatric Depression Scale 30 (GDS-30) score measure: Change in Generalized Anxiety Disorder 7 (GAD-7) score measure: Change in Short Form 36 (SF-36) score measure: Change in Alzheimer Disease Cooperative Study - Activities of Daily Living inventory (ADCS-ADL) score measure: Change in Lawton-Brody Instrumental Activities of Daily Living (LB-IADL) score measure: Change in Clinical Global Impression (CGI) score measure: Change in Short Physical Performance Battery (SPPB) score measure: Change in Timed Up & Go (TUG) score sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ontario Shores Centre for Mental Health Sciences status: RECRUITING city: Toronto state: Ontario zip: L1N 5S9 country: Canada name: Amer M. Burhan, MBChB, MSc role: CONTACT phone: 905.430.4055 phoneExt: 4019 email: burhana@ontarioshores.ca name: Adrian I. Espiritu, MD role: CONTACT phone: 905.430.4055 phoneExt: 6271 email: espiritua@ontarioshores.ca lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06323473 id: Maitake001 briefTitle: Maitake for Integrative Cancer Care acronym: Maitake overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-08-01 date: 2025-09-01 date: 2024-03-21 date: 2024-03-21 name: The Canadian College of Naturopathic Medicine class: OTHER briefSummary: Maitake is an edible mushroom that is used for both its nutritional and medicinal properties. Human and animal studies have shown Maitake may help improve immune function; however, its effectiveness in people with cancer is not clear. The investigators aim to measure if Maitake has any immunomodulatory effects when given alongside conventional systemic cancer therapy. conditions: Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Uncontrolled single arm clinical trial primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Black Maitake Prothera measure: Changes in absolute neutrophil count measure: Incidence of febrile neutropenia measure: Change in neutrophil to lymphocyte ratio (NLR) measure: Change in platelet to lymphocyte ratio (PLR) measure: Change in high-sensitivity C-reactive protein (CRP) measure: Changes in Quality of Life measure: Changes in hemoglobin A1c (HbA1c) measure: Incidence of adverse events measure: Incidence of dose reductions or delays in systemic therapy measure: Addition of new medications to combat neutropenia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Centre for Health Innovation city: Ottawa state: Ontario zip: K2P 0M7 country: Canada name: Mark Legacy role: CONTACT phone: 613-792-1222 phoneExt: 1 email: mlegacy@thechi.ca lat: 45.41117 lon: -75.69812 facility: Canadian College of Naturopathic Medicine - Integrative Cancer Centre city: Toronto state: Ontario zip: M2K 1E2 country: Canada name: Daniel Lander role: CONTACT phone: 416-498-1255 phoneExt: 280 email: dlander@ccnm.edu lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06323460 id: OSU-23083 id: NCI-2024-00904 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) briefTitle: Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer overallStatus: RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-21 date: 2024-03-21 name: Ohio State University Comprehensive Cancer Center class: OTHER briefSummary: This phase II trial studies how well using circulating tumor deoxyribonucleic acid (DNA) to guide lower dose radiation therapy works in treating patients with human papillomavirus infection (HPV)-associated oropharyngeal cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Recently, a blood test has been developed to detect the human papillomavirus in the blood and determine how many viral particles are present. Researchers want to compare any good and bad effects of using the lower dose radiation therapy with chemotherapy compared to the usual standard of care dose chemotherapy in patients who clear the human papillomavirus particles from their blood. conditions: Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 conditions: Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 conditions: Oropharyngeal Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Biospecimen Collection name: Carboplatin name: Cisplatin name: Computed Tomography name: External Beam Radiation Therapy name: Paclitaxel name: Positron Emission Tomography name: Questionnaire Administration measure: Positron emission tomography complete response measure: Progression free survival measure: Incidence of adverse events measure: Quality of life (QOL) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio State University Comprehensive Cancer Center status: RECRUITING city: Columbus state: Ohio zip: 43210 country: United States name: Sujith Baliga role: CONTACT phone: 614-293-5066 email: Sujith.baliga@osumc.edu name: Sujith Baliga role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06323447 id: PC002 briefTitle: Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia acronym: PC002 overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2025-04-30 date: 2025-05-28 date: 2024-03-21 date: 2024-03-21 name: Leuko Labs, Inc. class: INDUSTRY briefSummary: Pivotal study to validate the diagnostic performance of PointCheck, the first non invasive device to preliminary detect neutropenia in cancer patients receiving intermediate/high risk antineoplastic therapy. conditions: Diffuse Large B Cell Lymphoma conditions: Multiple Myeloma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 210 type: ESTIMATED name: PointCheck measure: PointCheck Accuracy measure: PointCheck Precision measure: PointCheck Usability measure: PointCheck Errors measure: PointCheck Safety sex: ALL minimumAge: 10 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06323434 id: spice1 briefTitle: Spinal CSF Leaks in Chronic Subdural Hematoma acronym: SPICE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-10 date: 2024-03-21 date: 2024-04-22 name: University of Freiburg class: OTHER briefSummary: Background: Chronic subdural hematoma (cSDH) is a type of intracranial bleeding, predominantly affecting the elderly and males, with an estimated incidence of 8/100.000. The collection of subdural fluid expands slowly, leading eventually to brain tissue compression that results in neurological impairment such as seizures, cognitive decline, and paresis. Most patients need neurosurgical evacuation of the blood to improve and to prevent further, possibly permanent deterioration. Evidently, the cause of such a bleeding must be investigated and if possible treated, or preventive strategies need to be installed if possible. Spinal cerebrospinal fluid (CSF) leaks are a known cause of cSDH but are widely underdiagnosed in this population.

The spinal CSF leak causes CSF loss that leads to intracranial hypotension, expansion of intracerebral veins, and traction to the brain and the surrounding tissues. A cSDH is a severe complication of such a leak and occurs in about 30% of all cases with a predominance among the elderly. It is crucial to identify these patients with a spinal leak as treatment pathways differ essentially from patients without a leak. Some smaller studies indicated a prevalence of spinal CSF leaks among cSDH patients of 30% to 80% depending on selection criteria (age, extend of cSDH). Notably, the entity of the CSF-venous fistula, that has been discovered as recent as 9 years ago, and that by now is accounting for 20-25% of all spinal leaks, has not been considered in previous research on cSDH and spinal CSF leaks.

Currently, there is no prospective data on spinal CSF leaks in patients with cSDH. Establishment of such data is crucial to improve diagnostic and therapeutic algorithms for spinal CSF leaks in patients with cSDH.

Objective: To prospectively assess the prevalence of spinal CSF leaks in patients with cSDH Methods: This is a prospective observational, monocentric study on patients admitted due to cSDH to the Department of Neurosurgery at the Medical Center of the University of Freiburg. Treatment and diagnostic procedures will follow standard protocols. The number of spinal CSF leaks will be assessed to generate the prevalence of spinal CSF leaks in this patient cohort. Furthermore, clinical data, the specific type of the CSF leak, and imaging parameters are assessed systematically to estimate the diagnostic value of these measures. conditions: Chronic Subdural Hematoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 220 type: ESTIMATED measure: evidence of a spinal CSF leak (yes/no) measure: Number of identified CSF leak types: measure: Number of diagnostic procedures performed: measure: Number, and site of interventions needed for cSDH: measure: Color of hematoma evacuated: measure: Age measure: body height measure: body weight measure: Body mass index (BMI) measure: sex measure: Karnofsky Index measure: Anti-platelet therapy intake measure: Anticoagulation intake measure: Blood pressure medication intake measure: Lipid regulation medication intake measure: Hormonal regulation medication intake measure: Immunotherapeutic medication intake measure: other medication intake measure: history of trauma measure: national institutes of health stroke scale (NIHSS) measure: gait disorder measure: Modified Rankin Scale (mRS) measure: Headache-Impact-Test (HIT)-6 measure: current working capacity, measure: complaints measure: headache severity measure: Days within the last month measure: maximum duration being continuously upright measure: severeness of dizziness measure: Severeness of shoulder- and neck pain measure: severeness of nausea measure: severeness of hearing disturbances and tinnitus measure: severeness of cognitive deficits measure: severeness of visual disturbances measure: exhaustion measure: ability to focus and concentrate measure: Patient's Global Impression of Change (PGIC) measure: Self-Administered Comorbidity Questionnaire (SCQ) measure: 5 dimension / 5 levels European Quality of life questionnaire (EQ-5D-5L) Index measure: 5 dimension / 5 levels European Quality of life questionnaire (EQ-5D-5L) visual analogue scale measure: Hematocrit measure: Size of the chronic subdural hematoma measure: Volumetry of the cranial compartments measure: Bern-Score according to Dobrocky et al measure: Spinal longitudinal extradural fluid collection (SLEC) measure: DiverTICula (TIC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Freiburg city: Freiburg state: Baden-Württemberg zip: 79106 country: Germany name: Katharina Wolf, Dr. role: CONTACT phone: +4076127093556 email: katharina.wolf@uniklinik-freiburg.de name: Jürgen Beck, Prof. role: PRINCIPAL_INVESTIGATOR name: Amir El Rahal, Dr. role: SUB_INVESTIGATOR name: Niklas Lützen, Dr. role: SUB_INVESTIGATOR name: Horst Urbach, Prof. role: SUB_INVESTIGATOR name: Mukesch J Shah, Dr. role: SUB_INVESTIGATOR name: Christian Taschner, Prof. role: SUB_INVESTIGATOR name: Marco Reisert, Dr. role: SUB_INVESTIGATOR name: Manou Overstijns role: SUB_INVESTIGATOR name: Katharina Wolf, Dr. role: SUB_INVESTIGATOR name: Florian Volz, Dr. role: SUB_INVESTIGATOR lat: 47.9959 lon: 7.85222 hasResults: False

 nctId: NCT06323421 id: STUDY2023-1359 briefTitle: Targeting Chronic Stress for Reducing Risk Factors for Colorectal Cancer acronym: MindCRC overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2025-04-15 date: 2025-08-31 date: 2024-03-21 date: 2024-03-21 name: University of Illinois at Chicago class: OTHER briefSummary: Many neighborhoods in Chicago experience daily exposure to stressors including economic inopportunity and violent crime in public spaces. There is mounting evidence that chronic psychosocial stress can facilitate carcinogenesis by modulating the gut microbiome and immune system. The proposed research aims to study the practice of mindfulness to mitigate CPS and reduce colorectal cancer risk factors among Black American women at elevated risk. conditions: Mindfulness conditions: Colon Cancer conditions: Females studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: Mindfulness measure: Feasibility measures measure: Acceptability measure: Body mass index measure: Stress measure measure: Fasting glucose measure: Gut microbiota composition measure: Gut inflammation measure: Adiposity measure: Epinephrine measure: Norepinephrine measure: Cortisol measure: Resting heart rate measure: Blood lipids measure: Fasting insulin measure: Hemoglobin A1c measure: Systemic inflammation sex: FEMALE minimumAge: 45 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Illinois at Chicago city: Chicago state: Illinois zip: 60612 country: United States name: Lisa Tussing-Humphreys, PhD role: CONTACT phone: 312-355-5521 email: tussing@uic.edu lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06323408 id: BZKF-AYA_1.0 briefTitle: Integrated Analysis of Therapy Response and Resistence in Embryonal Tumors and Gliomas acronym: BZKF-AYA overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-09 date: 2026-03 date: 2024-03-21 date: 2024-03-21 name: University Hospital Regensburg class: OTHER briefSummary: The treatment of adolescents and young adults (AYA, 15 to 39 years) with malignant intra-axial CNS parenchymal tumors such as IDH-mutated gliomas, medulloblastomas and ependymomas is still not curative in all cases. The tumor biology and clinical needs to diagnose and treat these tumors are comparable across all age groups, so an integrated treatment environment overseen by adult and pediatric neuro-oncology specialists seems promising to leverage synergisms and advance diagnostic and therapeutic development in these tumors. A comprehensive, prospective and integrated biomaterial and imaging-based pipeline for the multi-faceted evaluation of AYAs has not yet been established for AYA patients with brain tumors in Germany. Current diagnostic platforms neglect the integrative processing of data from MRI and FET-PET imaging, radiotherapy plans, tumor tissue, liquid biopsies and clinical data as well as prognostic markers. A prospective AYA pipeline can therefore enable a better understanding of the aforementioned high-risk CNS malignancies and promises clinical advances for AYA patients and the clinical and scientific research landscape. conditions: Glioma, Malignant conditions: Embryonal Tumor conditions: Medulloblastoma conditions: Ependymoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 72 type: ESTIMATED name: Tissue, blood, cerebrospinal-spinal fluid measure: AI processing of MRI fand PET or diagnosis measure: AI processing of MRI and PET for evaluation of response and relapse measure: Quality control analysis in radiotherapy measure: Analysis of response in liquid biopsies measure: Target molecules in tissue and liquid biopsies measure: Evaluation of progression free survival sex: ALL minimumAge: 15 Years maximumAge: 39 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06323395 id: JGL-DED-VIZ-SLB 21 briefTitle: Vizol S Lipid Balance Efficacy and Safety Study in Patients With Dry Eye overallStatus: COMPLETED date: 2022-06-01 date: 2022-12-01 date: 2022-12-01 date: 2024-03-21 date: 2024-03-21 name: Jadran Galenski laboratorij d.d. class: INDUSTRY name: Poseidon CRO briefSummary: The clinical investigation was intended to investigate the efficacy, ocular tolerability and safety of Vizol S Lipid Balance, a new eye drops, emulsion developed by JADRAN - GALENSKI LABORATORIJ d.d., in patients with moderate to severe evaporative DED after a treatment for 30 days. conditions: Dry Eye Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multi-centre, randomised, parallel-group, controlled (placebo), double-blind study primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: As the clinical trial will be conducted in a double-blind way, both investigators and patients will be blind with respect to the treatment administered. For the purpose of individual unblinding of a patient's treatment the investigator will receive a sealed emergency envelope for each patient containing the treatment code (Only in case of medical emergency it is permitted to open the emergency envelope). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 64 type: ACTUAL name: Vizol S LIPID BALANCE eye drops name: ophthalmic saline eye drops measure: Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 3 (day 30) measure: Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 15) measure: percent (%) change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 15) and from Visit 1 (baseline) to Visit 3 (day 30) measure: Mean change in ocular surface staining score (total corneal and total conjunctival staining score) from Visit 1 (baseline) to Visit 3 (day 30) measure: Mean change in OSDI score from Visit 1 (baseline) to Visit 3 (day 30) measure: Mean change in Meibomian gland expression from Visit 1 (baseline) to Visit 3 (day 30) measure: The presence of Adverse Event/ /Serious Adverse Event (AE/ /SAE) throughout the investigation period measure: BCVA measure: Frequency of ocular signs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Special eye hospital - Beogradski oftalmološki centar city: Belgrad zip: 11000 country: Serbia lat: 44.80401 lon: 20.46513 facility: Specialized clinic for eye desease - klinika Veselinović city: Niš zip: 18000 country: Serbia lat: 43.32472 lon: 21.90333 hasResults: False

 nctId: NCT06323382 id: Liver Project 6 briefTitle: Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma overallStatus: RECRUITING date: 2021-01-01 date: 2024-12-30 date: 2024-12-30 date: 2024-03-21 date: 2024-03-21 name: Sun Yat-sen University class: OTHER briefSummary: Atezolizumab + Bevacizumab was superior to sorafenib in overall survival in advanced hepatocellular carcinoma. The programmed cell death protein-1 (PD1) and PDL1 inhibitor, was effective and tolerable in patients with advanced hepatocellular carcinoma. We aimed to describe the efficacy and safety of locoregional therapy combined with Bevacizumab and PD1/L1 inhibitor in patients with advanced hepatocellular carcinoma who can not receive radical therapy. conditions: Advanced Hepatocellular Carcinoma conditions: Anti-PD1/PDL1 Antibody conditions: Bevacizumab studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 240 type: ESTIMATED name: Locoregional therapy name: Bevacizumab name: Atezolizumab name: Tislelizumab name: Toripalimab name: Sintilimab name: Camrelizumab measure: Progression-Free-Survival (PFS) measure: Overall survival (OS) measure: Objective response rate (ORR) measure: Adverse events sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese PLA hospital status: RECRUITING city: Beijing state: Beijing zip: 100853 country: China name: Qunfang Zhou, Md role: CONTACT phone: 8619868000115 email: zhouqun988509@163.com name: MD role: CONTACT phone: 8613910984586 email: duanfeng@vip.sina.com name: Feng Duan, MD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06323369 id: SYSKY-2023-1283-02 briefTitle: Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Clinically Node-negative Head and Neck Squamous Cell Carcinoma overallStatus: RECRUITING date: 2024-03-25 date: 2029-03-25 date: 2029-09-25 date: 2024-03-21 date: 2024-03-21 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: A prospective, randomized, open-label, multicenter Phase 2 trial designed to compare the efficacy and safety of Tislelizumab combined with chemotherapy followed by surgery versus up-front surgery in resectable clinically node-negative head and neck squamous cell carcinoma. conditions: Head and Neck Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 154 type: ESTIMATED name: Tislelizumab（neoadjuvant） name: Cisplatin （neoadjuvant） name: Nab-paclitaxel （neoadjuvant） name: Surgical resection name: Cisplatin（adjuvant） name: Tislelizumab（adjuvant） name: Radiation name: Carboplatin（neoadjuvant） name: Carboplatin（adjuvant） measure: Disease-Free Survival(DFS ) measure: Lymph node positivity rate measure: Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Adverse Events measure: Pathological complete response (pCR) rate measure: Major Pathological Response (MPR) rate measure: lymph node division measure: Event-free Survival (EFS) measure: Overall survival (OS) measure: Disease-Free Survival(DFS ) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Ethics Committee of Sun Yat-sen Memorial Hospital status: RECRUITING city: Guangzhou state: Yuexiu zip: 510120 country: China name: Song Fan, Doctor role: CONTACT phone: 13570536658 phoneExt: +86 email: fansong2@mail.sysu.edu.cn name: Song Fan, Doctor role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06323356 id: TAK-279-PsO-3005 id: jRCT2031230714 type: REGISTRY domain: jRCT briefTitle: A Study of TAK-279 in Adult Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis overallStatus: RECRUITING date: 2024-03-19 date: 2025-06-30 date: 2026-03-27 date: 2024-03-21 date: 2024-04-10 name: Takeda class: INDUSTRY briefSummary: The main aim of this study is to check if TAK-279 improves symptoms of With Generalized Pustular Psoriasis (GPP) or Erythrodermic Psoriasis (EP) and side effect from the study treatment or TAK-279.

All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules.

Participants will be in the study for up to 61 weeks including 52 weeks of study treatment. During the study, participants will visit their study clinic for multiple times. conditions: Generalized Pustular Psoriasis conditions: Erythrodermic Psoriasis studyType: INTERVENTIONAL phases: PHASE3 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: TAK-279 measure: Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 measure: Percentage of Participants Achieving ≥75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16 measure: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 52 measure: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Both Week 16 and Week 52 Visits measure: Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 and Week 52 measure: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) at Week 16 and Week 52 measure: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) at Week 16 and Week 52 Visits measure: Percentage of Participants Achieving PASI-75 at Week 52 measure: Percentage of Participants Achieving PASI-90 at Week 16 and Week 52 measure: Percentage of Participants Achieving PASI-100 at Week 16 and Week 52 measure: Percentage of Participants Achieving PASI-75 at Both the Week 16 and Week 52 Visits measure: Percentage of Participants Achieving PASI-90 at Both the Week 16 and Week 52 Visits measure: Percentage of Participants Achieving a Scalp-specific Physician's Global Assessment (ssPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 and Week 52 measure: Change from baseline in ssPGA at Weeks 16 and 52 measure: Percentage of Participants Achieving a PGA of the Hands and/or Feet of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Weeks 16 and Week 52 measure: Percentage of Participants with a Baseline Dermatology Life Quality Index (DLQI) Score ≥2 who Achieve DLQI Score of 0 or 1 at Week 16 and Week 52 measure: Change from Baseline in DLQI at Week 16 and Week 52 measure: Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 and Week 52 Among Participants with Nail Involvement at Baseline measure: Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 and Week 52 measure: Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a Generalized Pustular Psoriasis Global Assessment (GPPGA) Pustulation Subscore of No Visible Pustules (0) at Week 16 and Week 52 measure: Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a GPPGA of Clear (0) or Almost Clear (1) at Weeks 16 and Week 52 measure: Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a GPPGA of Clear (0) at Week 16 and Week 52 measure: Percentage of Participants with Generalized Pustular Psoriasis Who Achieve ≥75% Improvement from Baseline in Generalized Pustular Psoriasis Area and Severity Index (GPPASI) Score at Week 16 and Week 52 measure: Change from Baseline in Japanese Dermatological Association Severity Index (JDASI) Score at Week 16 and Week 52 for Participants with Generalized Pustular Psoriasis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nagoya City University Hospital status: NOT_YET_RECRUITING city: Nagoya state: Aichi country: Japan lat: 35.18147 lon: 136.90641 facility: Fujita Health University Hospital status: NOT_YET_RECRUITING city: Toyoake state: Aichi country: Japan lat: 35.038 lon: 136.99931 facility: Kimitsu Chuo Hospital status: RECRUITING city: Kisarazu state: Chiba country: Japan lat: 35.38329 lon: 139.93254 facility: Juntendo University Urayasu Hospital status: NOT_YET_RECRUITING city: Urayasu state: Chiba country: Japan lat: 35.67054 lon: 139.88862 facility: Hospital of the University of Occupational and Environmental Health, Japan status: RECRUITING city: Kitakyushu state: Fukuoka country: Japan lat: 33.85181 lon: 130.85034 facility: Isesaki Municipal Hospital status: NOT_YET_RECRUITING city: Isesaki state: Gunma country: Japan lat: 36.31667 lon: 139.2 facility: Kobe University Hospital status: NOT_YET_RECRUITING city: Kobe state: Hyogo country: Japan lat: 34.6913 lon: 135.183 facility: Tokai University Hospital status: NOT_YET_RECRUITING city: Isehara state: Kanagawa country: Japan lat: 35.39932 lon: 139.31019 facility: Mie University Hospital status: NOT_YET_RECRUITING city: Tsu state: Mie country: Japan lat: 34.73333 lon: 136.51667 facility: Kansai Medical University Hospital status: NOT_YET_RECRUITING city: Hirakata state: Osaka country: Japan lat: 34.81352 lon: 135.64914 facility: Saitama Medical University Hospital status: NOT_YET_RECRUITING city: Iruma state: Saitama country: Japan facility: St.Luke's International Hospital status: NOT_YET_RECRUITING city: Chuo City state: Tokyo country: Japan lat: 35.57779 lon: 139.71685 facility: Teikyo University Hospital status: NOT_YET_RECRUITING city: Itabashi-ku state: Tokyo country: Japan lat: 35.74893 lon: 139.71497 facility: The Jikei University Hospital status: NOT_YET_RECRUITING city: Minato-ku state: Tokyo country: Japan lat: 34.2152 lon: 135.1501 facility: Tokyo Medical University Hospital status: NOT_YET_RECRUITING city: Shinjuku-ku state: Tokyo country: Japan lat: 35.2946 lon: 139.57059 facility: Fukuoka University Hospital status: NOT_YET_RECRUITING city: Fukuoka country: Japan lat: 33.6 lon: 130.41667 facility: University Hospital, Kyoto Prefectural University of Medicine status: NOT_YET_RECRUITING city: Kyoto country: Japan lat: 35.02107 lon: 135.75385 facility: Okayama University Hospital status: NOT_YET_RECRUITING city: Okayama country: Japan lat: 34.65 lon: 133.93333 facility: Nippon Life Hospital status: NOT_YET_RECRUITING city: Osaka country: Japan lat: 34.69374 lon: 135.50218 facility: Osaka Metropolitan University Hospital status: NOT_YET_RECRUITING city: Osaka country: Japan lat: 34.69374 lon: 135.50218 hasResults: False

 nctId: NCT06323343 id: 00040976 briefTitle: Mobile Video Education to Improve Patient Clinician Communication During Prenatal Clinic Visits overallStatus: NOT_YET_RECRUITING date: 2024-05-28 date: 2024-10-01 date: 2025-01-31 date: 2024-03-21 date: 2024-03-21 name: Medical College of Wisconsin class: OTHER briefSummary: The goal of this clinical trial is to test an animated video delivered by text message in patients whose pregnancies are complicated with fetal anomalies. The main question it aims to answer is: Does the video intervention prepare parents to talk to the doctors during prenatal appointments?

Participants will be randomized to receive either the video intervention or links to the clinic's webpages. They will complete an enrollment survey before their appointment and a follow up survey after their appointment.

The researchers will compare the video and webpage groups to see which group reports engaging in more of the identified best-practices of communication. conditions: Patient Empowerment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 114 type: ESTIMATED name: Video Intervention name: Webpage links measure: Parents' communication behaviors measure sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06323330 id: I-1623 briefTitle: Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-10-31 date: 2026-11-30 date: 2024-03-21 date: 2024-03-21 name: All India Institute of Medical Sciences, New Delhi class: OTHER name: Institute of Human Behavior and Allied Sciences name: Indian Institute of Technology, New Delhi name: Vardhman Mahavir Medical College And Safdarjung Hospital briefSummary: The goal of this Interventional Study is to develop and test the Indian Adaptation of Melodic Intonation Therapy (MIT) for Indian patients in with post-stroke Non-Fluent Aphasia (PSNFA). The main question\[s\] it aims to answer are: • To develop the MIT Indian Adaptation tool and check its feasibility • To compare the MIT with standard speech rehabilitation in patient with PSNFA. Participants will undergo Speech Rehabilitation according to the developed module and the standard treatment will be given in the comparator arm. The speech recovery at 12 weeks will be compared in both treatment arms. conditions: Stroke Rehabilitation conditions: Aphasia, Broca studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The MIT- Indian Adaptation will be tested and compared with standard speech rehabilitation in post-stroke non-fluent aphasia primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The outcome assessor will be blinded to the intervention whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Speech rehabilitation measure: Western Aphasia Battery Score measure: Western Aphasia Battery Score measure: functional Near Red Spectroscopy measures measure: modified Rankin Score measure: Fugl Meyer Assessment Scores sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06323317 id: UW 21-405 briefTitle: A Prehabilitation Program for Frail Patients Undergoing Cardiac Surgeries/Procedures acronym: PREHAB overallStatus: RECRUITING date: 2023-12-18 date: 2024-12-31 date: 2025-03-31 date: 2024-03-21 date: 2024-03-21 name: The University of Hong Kong class: OTHER briefSummary: The purpose of this study is to develop and evaluate a frailty-specific prehabilitation program for patients awaiting cardiac surgeries/procedures. The program aims to improve functional capacity, frailty level, cardiac-related physical functioning, health-related quality of life (HRQoL), psychological distress, major adverse cardiovascular and cerebral events (MACCE), hospital length of stay, and readmission rates.

Cardiovascular disease is a leading cause of disability and morbidity globally, particularly in older adults. Frailty, a geriatric syndrome commonly seen in cardiac patients, complicates their perioperative care and leads to worse outcomes.

Prehabilitation, which optimizes patients' physiological and functional capacities before surgery, has shown promise in general cardiac patients but requires a more comprehensive approach for frail individuals. This randomized controlled trial will recruit 50 Chinese adults awaiting elective cardiac surgeries/procedures in Hong Kong. Participants will be randomly assigned to either the intervention group, receiving a comprehensive prehabilitation program, or the control group, receiving routine preoperative care. Assessments will be conducted at baseline and at three postoperative time points.

The findings will contribute to our understanding of the impact of frailty on postoperative outcomes and help develop strategies to improve patient care. Ultimately, this study aims to reduce healthcare burdens associated with cardiac disease-related morbidity and disability. conditions: Coronary Artery Bypass Grafting conditions: Heart Valve Replacement conditions: Transcatheter Aortic Valve Implantation conditions: Frailty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The post-intervention data collector (research assistant) will be blinded to the group allocation to avoid performance and detection biases. whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Multi-component exercise programme name: Attention Placebo name: Structured preoperative education name: Nutritional optimization name: Stress management measure: The Short Physical Performance Battery (SPPB) measure: Weakness/ Grip Strength (Fried Phenotype Frailty Assessment) measure: Slowness (Fried Phenotype Frailty Assessment) measure: Low Physical Activity (Fried Phenotype Frailty Assessment) measure: Self-reported Exhaustion (Fried Phenotype Frailty Assessment) measure: Unintentional Weight Loss (Fried Phenotype Frailty Assessment) measure: The Seattle Angina Questionnaire (SAQ) measure: The MacNew Heart Disease Health-Related Quality of Life Questionnaire measure: The Hospital Anxiety and Depression Scale (HADS) measure: Biomarkers-Serum albumin measure: Biomarkers- C-reactive protein measure: Major adverse cardiac and cerebrovascular events (MACCE) measure: Hospital Length of stay measure: Hospital Readmissions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Polly Wai Chi status: RECRUITING city: Hong Kong state: Please Select zip: 00000 country: Hong Kong name: Polly Wai Chi Li, PhD role: CONTACT email: pwcli@hku.hk lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06323304 id: 701/HDDD-DHYD briefTitle: Efficacy and Safety of Auricular Acupressure in Treating Allergic Rhinitis overallStatus: RECRUITING date: 2024-03-13 date: 2024-06 date: 2024-06 date: 2024-03-21 date: 2024-04-04 name: University of Medicine and Pharmacy at Ho Chi Minh City class: OTHER briefSummary: Allergic rhinitis (AR) is a global health problem affecting approximately 10% to 40% of the population worldwide, with an increasing trend. It significantly impacts health and quality of life. Current treatments for AR include allergen avoidance, symptom-relieving medications, anti-inflammatory therapy, and allergen-specific immunotherapy. However, many patients still experience uncontrolled symptoms despite these approaches, either as monotherapy or in combination, along with medication side effects such as drowsiness, dry eyes, nasal mucosal damage, and immunosuppression.

Auricular acupressure therapy (AAT) utilizes ear acupoints by applying pressure with ear seeds. The neurobiological mechanisms of AAT on the human body have gained increasing attention in clinical and experimental studies, involving anti-inflammatory, antioxidant, and immunomodulatory effects. Its efficacy has been recognized, becoming a potential alternative therapy for various conditions such as sleep disorders, obesity, and chronic pain. Previous clinical studies have reported the efficacy and safety of AAT in treating AR. However, the primary outcomes of these studies remain inconsistent and lack specific criteria for evaluating AR treatment efficacy.

This study aims to investigate the efficacy and safety of AAT in treating AR based on the ARIA guideline 2019 treatment efficacy criteria. It will provide a basis for applying AAT as a complementary approach in the multimodal treatment of AR. conditions: Itching conditions: Runny Nose conditions: Sneezing conditions: Nasal Congestion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Triple-blind method (Participant, Investigator, Outcome assessor) Participants will be blinded to their randomization assignment, either to the intervention group or the control group. Sham acupressure therapy will be performed at acupoints that have no therapeutic effect on allergic rhinitis, and the procedures will be similar to auricular pressure therapy. Both groups will be treated with fluticasone propionate nasal spray, which is the standard treatment.

The physician who perform auricular acupressure therapy or sham acupressure therapy will be aware of the intervention assignment for each group, but they will not be involved in data analysis or outcome assessment. The data analysts and outcome assessors will be blinded to the treatment assignment. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Auricular acupressure name: Sham acupressure name: Standard treatment measure: The change of nasal and non nasal symptom scores measure: The change of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score measure: The change of relief medication usage measure: Proportion of intervention-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: University of Medical Center HCMC - Branch no.3 status: RECRUITING city: Ho Chi Minh zip: 700000 country: Vietnam name: Chau Ngoc Le, MD role: CONTACT phone: +84942831722 email: lnchau.ntyhct21@ump.edu.vn name: Minh-Man Pham Bui, MD role: CONTACT phone: +84916080803 email: bpmman@ump.edu.vn lat: 10.82302 lon: 106.62965 hasResults: False

 nctId: NCT06323291 id: MCC-23077 briefTitle: Cancer Coaching and Remote Education for Self-Empowerment (CARES) Study overallStatus: RECRUITING date: 2024-04-01 date: 2026-03 date: 2026-03 date: 2024-03-21 date: 2024-04-12 name: H. Lee Moffitt Cancer Center and Research Institute class: OTHER name: Canopy Cancer Collective briefSummary: This Pilot Study will evaluate a 12-week pilot program that offers digital health coaching for individuals with pancreatic cancer and their caregivers. conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 20 type: ESTIMATED name: Coaching Sessions measure: Recruitment Rate measure: Participant Acceptance of the Digital Health Coaching Program measure: Participant Ease of Usability of the Digital Health Coaching Program measure: Feasibility of Utilizing the Digital Health Coaching Program sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Moffitt Cancer Center status: RECRUITING city: Tampa state: Florida zip: 33612 country: United States name: Emma Hume role: CONTACT phone: 813-745-6426 email: Emma.Hume@moffitt.org name: Kea Turner, MPH, PhD role: PRINCIPAL_INVESTIGATOR name: Pamela Hodul, MD role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 hasResults: False

 nctId: NCT06323278 id: PD&REHAB briefTitle: Effectiveness of Cognitive Stimulation Treatment in Patients With Parkinson's Disease overallStatus: RECRUITING date: 2021-12-21 date: 2026-12 date: 2027-12 date: 2024-03-21 date: 2024-03-21 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: The goal of this observational study is to evaluate the relationship between GBA mutation and cognitive stimulation treatment response in patients with Parkinson's disease. The main questions it aim to answer are: • assess whether the GBA mutation is associated with greater or lesser response to cognitive training treatment compared to a control group of PD patients without genetic mutations. • investigate the effect of cognitive stimulation program on behavioural aspects as secondary consequence induced by the possible improvement of cognitive abilities following treatment.

Participants will be undergo to: - a neuropsychological evaluation describing their cognitive profile; - a genetic investigation and finally included in a cognitive stimulation programs according to regular clinical practice. Researchers will compare PD patients with GBA mutation and patients without genetic mutation to evaluate the effectiveness of cognitive stimulation treatment. conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 68 type: ESTIMATED name: Cognitive training measure: Efficacy of the cognitive training on cognitive function in PD patients with GBA mutation compared to a control group of PD patients without genetic mutations. measure: The effect of cognitive training on behavioural aspects in PD patients. measure: The effect of cognitive training on behavioural aspects in PD patients. measure: The effect of cognitive training on behavioural aspects in PD patients. measure: The effect of cognitive training on behavioural aspects in PD patients. measure: The effect of cognitive training on behavioural aspects in PD patients. measure: The effect of cognitive training on behavioural aspects in PD patients. measure: The effect of cognitive training on behavioural aspects in PD patients. measure: The effect of cognitive training on behavioural aspects in PD patients. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: RECRUITING city: Milan country: Italy name: Fabiana Ruggiero, MSc in Psychology role: CONTACT phone: +390255033621 email: fabiana.ruggiero@policlinico.mi.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06323265 id: ARL-SCLC-001 briefTitle: A Real-world Study of Adebrelimab Combined With Chemotherapy±Chest Radiotherapy in Patients With Extensive Stage Small Cell Lung Cancer overallStatus: RECRUITING date: 2024-03-26 date: 2025-04-01 date: 2026-04-01 date: 2024-03-21 date: 2024-03-27 name: Hebei Medical University Fourth Hospital class: OTHER briefSummary: The purpose of this study is to assess efficacy and safety of patients who receive Adebrelimab combined with chemotherapy±chest radiotherapy as first-line treatment of extensive stage small cell lung cancer in the real world. conditions: Extensive Stage Small Cell Lung Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Adebrelimab + chemotherapy name: ±chest radiotherapy measure: Progression free survival (PFS) measure: Objective response rate (ORR) measure: Disease control rate (DCR) measure: Duration of Overall Response（DoR） measure: Overall survival (OS) measure: Adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jun Wang status: RECRUITING city: Shijiazhuang state: Hebei country: China name: Jun Wang role: CONTACT phone: 13931182128 email: wangjunzr@163.com lat: 38.04139 lon: 114.47861 hasResults: False

 nctId: NCT06323252 id: MastihaOil-HT briefTitle: A Study on the Effects of Mastiha Oil in Adults With Hypertriglyceridemia overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-10-30 date: 2025-10-30 date: 2024-03-21 date: 2024-03-21 name: Harokopio University class: OTHER briefSummary: Mastiha Oil is a 100% natural product of the Mediterranean, extracted from the resin of Mastiha. Its composition is high in bioactive ingredients (such as terpenic acids and polyphenols) which have proven anti-inflammatory, antioxidant, cardioprotective, chemoprotective and antimicrobial properties. The aim of this study is to determine the effect of Mastiha oil in adults with Hypetriglyceridemia. 100 participants will be allocated to two groups, (50 in intervention group and 50 in control group). Mastiha oil will be provided in the form of soft gel capsules to the intervention group, whereas the control group will not consume the capsules. Both groups will receive standard nutritional counselling. The intervention will last 3 months.

The effects of the intervention will be evaluated via clinical and laboratory markers. conditions: Hypertriglyceridemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: MastihaOil name: nutritional counsel measure: Change in blood triglycerides sex: ALL minimumAge: 30 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06323239 id: SBRT/LDRT+PD-1+GP for r/mNPC briefTitle: SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2028-04-01 date: 2024-03-21 date: 2024-03-21 name: Sun Yat-sen University class: OTHER briefSummary: This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients. conditions: Nasopharyngeal Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 148 type: ESTIMATED name: SBRT name: Low-dose Radiotherapy (LDRT) name: Toripalimab name: Gemcitabine name: Cisplatin name: IMRT measure: Progression-free survival measure: Overall Survival measure: Objective Response Rate measure: Disease Control Rate measure: Adverse Events measure: QoL sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06323226 id: 2024-312-1 briefTitle: The Impact of Sepsis on Long-term Outcomes in Critical Ill Children With Sepsis overallStatus: RECRUITING date: 2019-01-01 date: 2025-01-01 date: 2025-06-01 date: 2024-03-21 date: 2024-03-21 name: West China Hospital class: OTHER briefSummary: This study is conducted in critically ill children with sepsis with a five years follow-up. We aim to investigate the impact of sepsis on long-term outcomes including growth, neurodevelopment, survival rate, quality of life. conditions: Sepsis conditions: Children, Only studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: Mortality sex: ALL minimumAge: 0 Years maximumAge: 16 Years stdAges: CHILD facility: West China Hospital of Sichuan University status: RECRUITING city: Chendu state: Sichuan country: China name: Ji Yi, Doctor role: CONTACT hasResults: False

 nctId: NCT06323213 id: SSGJ-610-BA-III-01 briefTitle: Efficacy and Safety Study of 610 in Patients With Severe Asthma overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-06 date: 2026-09 date: 2024-03-21 date: 2024-03-21 name: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. class: INDUSTRY briefSummary: The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma. conditions: Asthma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 480 type: ESTIMATED name: 610 name: Placebo measure: Annualized rate of severe exacerbation events measure: Time to first severe exacerbation event measure: Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit measure: Change from baseline in ACQ score measure: Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ) measure: Change in pre-bronchodilator forced expiratory volume (FEV1) measure: Assessment of adverse events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06323200 id: 202400221B0 briefTitle: Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA acronym: LVA overallStatus: COMPLETED date: 2015-09 date: 2023-03 date: 2023-03 date: 2024-03-21 date: 2024-03-21 name: Chang Gung Memorial Hospital class: OTHER briefSummary: This study aimed to address the impact of lymphedema duration on the quality of lymphatic vessels as well as the outcome after LVA using propensity score matching. conditions: Lymphedema studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 189 type: ACTUAL name: lymphaticovenous anastomosis measure: Volume change after LVA. sex: ALL minimumAge: 20 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06323187 id: 4656 briefTitle: Optimization of Cervical Collections in Pregnancy acronym: OCCP overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-02-28 date: 2031-02-28 date: 2024-03-21 date: 2024-03-21 name: Dr. Sascha Drewlo class: OTHER briefSummary: Fetal cells are not easily obtained from pregnant patients; this curtails testing to assess the health of the fetus and the mother. Currently, the only way of diagnosing fetal genetic or chromosomal abnormalities is by invasive techniques, such as chorionic villous sampling (CVS) and amniocentesis performed at 10 to 13 weeks and after 15 weeks of gestation, respectively. Although small, there is a risk for fetal loss with these procedures. Transcervical cell sampling (TCS), similar to a Pap smear, is a platform that meets the requirements for prenatal genetic testing (genetic testing with fetal cells obtained before birth), as well as diagnosis of maternal pregnancy complication, at a very early stage of pregnancy (as early as 5 weeks) and carries low risk for the mother and the developing fetus.

This study will examine cervical fluid collected using various noninvasive methods for TCS in pregnant women. The number of placental cells will be assessed against similarly obtained samples from nonpregnant women of reproductive age who lack cells derived from a placenta. Participating volunteers will provide written informed consent. Only standard medical procedures and approved devices will be used for collection of cervical fluid, minimizing risk to the participants and their fetuses. No test results or other benefits will be available to the participants. conditions: Cervix; Pregnancy conditions: Inherited Genetic Conditions (Diagnosis) conditions: Preeclampsia conditions: Fetal Growth Retardation studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 2600 type: ESTIMATED name: Cervical Sampling measure: Cellular content measure: Cell-free content sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06323174 id: NN9388-4895 id: 2022-502677-42 type: OTHER domain: European Medical Agency (EMA) id: U1111-1283-0404 type: OTHER domain: World Health Organization (WHO) briefTitle: A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise acronym: REIMAGINE 1 overallStatus: RECRUITING date: 2024-03-19 date: 2025-08-12 date: 2025-11-04 date: 2024-03-21 date: 2024-04-03 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study will look at how much CagriSema helps participants with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: Cagrilintide name: Semaglutide name: Placebo measure: Change in glycated haemoglobin (HbA1c) measure: Relative change in body weight measure: Number of participants who achieve greater than or equal to (>=) 10% body weight reduction measure: Number of participants who achieve >=15% body weight reduction measure: Number of participants who achieve HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol]) measure: Number of participants who achieve HbA1c target values of less than or equal to (<=) 6.5% (<= 48 mmol/mol) measure: Change in Fasting Plasma Glucose (FPG) measure: Number of participants who achieve >=5% body weight reduction measure: Number of participants who achieve >=20% body weight reduction measure: Change in waist circumference measure: Change in systolic blood pressure (SBP) measure: Change in diastolic blood pressure (DBP) measure: Ratio to baseline in high sensitivity C-reactive protein (hsCRP) measure: Ratio to baseline in lipids: Total cholesterol measure: Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol measure: Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol measure: Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol measure: Ratio to baseline in lipids: Triglycerides measure: Ratio to baseline in lipids: Free fatty acids measure: Ratio to baseline in lipids: Non-HDL cholesterol measure: Number of participants who achieve type 2 diabetes (T2D) remission (HbA1c <6.5% and no antidiabetic medication) measure: Ratio to baseline in oral glucose tolerance test (OGTT) based oral glucose disposition index (DIo) measure: Change in experienced level of energy as measured by the SF-36v2 Health Survey Acute (SF-36v2) Vitality score measure: Change in SF-36v2 score: Physical Component Summary score measure: Change in SF-36v2 score: Mental Component Summary score measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score measure: Change in leptin measure: Change in soluble leptin receptor measure: Number of Treatment Emergent Adverse Events (TEAEs) measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose (BG) meter measure: Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Research Institute_Huntington Park status: RECRUITING city: Huntington Park state: California zip: 90255 country: United States lat: 33.98168 lon: -118.22507 facility: Valley Clinical Trials, Inc. status: RECRUITING city: Northridge state: California zip: 91325 country: United States lat: 34.22834 lon: -118.53675 facility: Southern California Dermatology status: RECRUITING city: Santa Ana state: California zip: 92701 country: United States lat: 33.74557 lon: -117.86783 facility: Encore Medical Research LLC status: RECRUITING city: Hollywood state: Florida zip: 33021 country: United States lat: 26.0112 lon: -80.14949 facility: Alliance for Multispec Res status: NOT_YET_RECRUITING city: Newton state: Kansas zip: 67114 country: United States lat: 38.04668 lon: -97.34504 facility: Brigham & Women's Hospital status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: Arcturus Healthcare, PLC status: RECRUITING city: Troy state: Michigan zip: 48098 country: United States lat: 42.60559 lon: -83.14993 facility: Holston Medical Group status: RECRUITING city: Kingsport state: Tennessee zip: 37660 country: United States lat: 36.54843 lon: -82.56182 facility: Velocity Clinical Res-Dallas status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States lat: 32.78306 lon: -96.80667 facility: Northeast Clinical Research of San Antonio status: RECRUITING city: San Antonio state: Texas zip: 78233 country: United States lat: 29.42412 lon: -98.49363 facility: Consano Clinical Research, LLC status: RECRUITING city: Shavano Park state: Texas zip: 78231 country: United States lat: 29.58495 lon: -98.55252 facility: Consano Clinical Research, LLC status: NOT_YET_RECRUITING city: Shavano Park state: Texas zip: 78231 country: United States lat: 29.58495 lon: -98.55252 facility: TPMG Clinical Research status: RECRUITING city: Newport News state: Virginia zip: 23606 country: United States lat: 37.08339 lon: -76.46965 facility: Chinese People's Liberation Army General Hospital status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100853 country: China lat: 39.9075 lon: 116.39723 facility: The Second Affiliated Hospital of Nanjing Medical University_Nanjing status: NOT_YET_RECRUITING city: Nanjing state: Jiangsu zip: 210011 country: China lat: 32.06167 lon: 118.77778 facility: The Affiliated Hospital of Jiangsu University_Zhenjiang status: NOT_YET_RECRUITING city: Zhenjiang state: Jiangsu zip: 212001 country: China lat: 32.21086 lon: 119.45508 facility: Jinan Central Hospital status: NOT_YET_RECRUITING city: Ji'Nan state: Shandong zip: 250000 country: China lat: 36.66833 lon: 116.99722 facility: Belinus Bt. status: NOT_YET_RECRUITING city: Debrecen state: Hajdu-Bihar Varmegye zip: 4025 country: Hungary lat: 47.53333 lon: 21.63333 facility: Borbánya Praxis E.Ü. Kft. status: NOT_YET_RECRUITING city: Nyíregyháza state: Szabolcs-Szatmar Varmegye zip: 4405 country: Hungary lat: 47.95539 lon: 21.71671 facility: Azienda Ospedaliera Papa Giovanni XXIII status: NOT_YET_RECRUITING city: Bergamo zip: 24127 country: Italy lat: 45.69601 lon: 9.66721 facility: Policlinico Mater Domini Università di Catanzaro status: NOT_YET_RECRUITING city: Catanzaro zip: 88100 country: Italy lat: 38.88247 lon: 16.60086 facility: IRCCS Ospedale San Raffaele Milano status: NOT_YET_RECRUITING city: Milano zip: 20132 country: Italy lat: 45.46427 lon: 9.18951 facility: Azienda Ospealiero Universitaria Policlinico Umberto I status: NOT_YET_RECRUITING city: Roma zip: 00161 country: Italy lat: 41.89193 lon: 12.51133 facility: Centrum Medyczne Medyk Sp. z o.o. status: NOT_YET_RECRUITING city: Rzeszow state: Podkarpackie zip: 35-055 country: Poland lat: 50.04132 lon: 21.99901 facility: Renew Clinic Bialystok status: NOT_YET_RECRUITING city: Białystok zip: 15-794 country: Poland lat: 53.13333 lon: 23.16433 facility: Centrum Terapii Wspolczesnej status: NOT_YET_RECRUITING city: Lodz zip: 90-338 country: Poland lat: 51.75 lon: 19.46667 facility: NBR Polska Tomasz Klodawski status: NOT_YET_RECRUITING city: Warszawa zip: 00-710 country: Poland lat: 52.22977 lon: 21.01178 facility: King Abdulaziz Hospital-Al Ahsa-National Guard status: NOT_YET_RECRUITING city: Al Ahsa zip: 36428 country: Saudi Arabia facility: National Guard Hospital - Jeddah status: NOT_YET_RECRUITING city: Jeddah zip: 21423 country: Saudi Arabia lat: 21.54238 lon: 39.19797 facility: King Fahad Medical City status: NOT_YET_RECRUITING city: Riyadh zip: 11525 country: Saudi Arabia lat: 24.68773 lon: 46.72185 facility: King Khaled University Hospital,King Saud Univ. Med. City status: NOT_YET_RECRUITING city: Riyadh zip: 12372 country: Saudi Arabia lat: 24.68773 lon: 46.72185 facility: King Salman Bin Abdulaziz Hospital status: NOT_YET_RECRUITING city: Riyadh zip: 12769 country: Saudi Arabia lat: 24.68773 lon: 46.72185 facility: CHC Zvezdara, Clinical department for endocrinology status: NOT_YET_RECRUITING city: Belgrade zip: 11000 country: Serbia lat: 44.80401 lon: 20.46513 facility: Clinical Hospital Center Bezanijska Kosa status: NOT_YET_RECRUITING city: Belgrade zip: 11080 country: Serbia lat: 44.80401 lon: 20.46513 facility: Clinical Hospital Centre Zemun status: NOT_YET_RECRUITING city: Belgrade zip: 11080 country: Serbia lat: 44.80401 lon: 20.46513 hasResults: False

 nctId: NCT06323161 id: NN9388-7637 id: U1111-1283-0754 type: OTHER domain: World Health Organization (WHO) id: 2022-502679-43 type: OTHER domain: European Medical Agency (EMA) briefTitle: A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Once-daily Basal Insulin With or Without Metformin acronym: REIMAGINE 3 overallStatus: RECRUITING date: 2024-03-26 date: 2025-09-16 date: 2025-11-04 date: 2024-03-21 date: 2024-04-22 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study will look at how much CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participant will get either CagriSema or "dummy" medicine and which treatment they get is decided by chance. Participant will take the study medicine together with their current diabetes medicine (once-daily insulin with or without metformin). For each participant, the study will last for about one year. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 270 type: ESTIMATED name: Cagrilintide name: Semaglutide name: Placebo measure: Change in Glycated Haemoglobin (HbA1c) measure: Relative Change in Body Weight measure: Number of Participants Who Achieve Greater than or Equal to (≥) 10% Body Weight Reduction measure: Number of Participants Who Achieve ≥15% Body Weight Reduction measure: Number of Participants Who Achieve HbA1c Target Values of Less than (<) 7.0% (<53 millimole per mole [mmol/mol]) measure: Number of Participants Who Achieve HbA1c Target Values of Less than or Equal to (≤) 6.5% (≤48 mmol/mol) measure: Change in Fasting Plasma Glucose (FPG) measure: Change in Insulin Dose measure: Number of Participants Who Achieve Insulin Dose Equal to (=) 0 Units measure: Change in 7-point Self-measured Plasma Glucose (SMPG) Profiles: Mean 7-point profile and Mean postprandial increment (over all meals) measure: Number of Participants Who Achieve ≥5% Body Weight Reduction measure: Number of Participants Who Achieve ≥20% Body Weight Reduction measure: Change in Waist Circumference measure: Change in Systolic Blood Pressure (SBP) measure: Change in Diastolic Blood Pressure (DBP) measure: Ratio to Baseline in High Sensitivity C-reactive Protein (hsCRP) measure: Ratio to Baseline in Lipids: Non-high Density Lipoprotein (Non-HDL) Cholesterol measure: Ratio to Baseline in Lipids: Triglycerides measure: Ratio to Baseline in Lipids: Low-Density Lipoprotein (LDL) Cholesterol measure: Ratio to Baseline in Lipids: Very Low-Density Lipoprotein (VLDL) cholesterol measure: Ratio to Baseline in Lipids: HDL Cholesterol measure: Ratio to Baseline in Lipids: Total Cholesterol measure: Ratio to Baseline in Lipids: Free Fatty Acids measure: Change in Short Form-36 Version 2.0 Health Survey (SF-36v2): Vitality score measure: Change in SF-36v2: Physical Component Summary Score measure: Change in SF-36v2: Mental Component Summary Core measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score measure: Change in Leptin measure: Change in Soluble Leptin Receptor measure: Number of Treatment Emergent Adverse Events (TEAEs) measure: Number of Clinically Significant Hypoglycaemic Episodes (level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose Meter) measure: Number of Clinically Significant Hypoglycaemic Episodes (level 3) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Valley Clinical Trials, Inc. status: RECRUITING city: Northridge state: California zip: 91325 country: United States lat: 34.22834 lon: -118.53675 facility: Bioclinical Research Alliance status: RECRUITING city: Miami state: Florida zip: 33155 country: United States lat: 25.77427 lon: -80.19366 facility: Solaris Clinical Research status: RECRUITING city: Meridian state: Idaho zip: 83646 country: United States lat: 43.61211 lon: -116.39151 facility: Iowa Diab & Endo Res Center status: RECRUITING city: West Des Moines state: Iowa zip: 50265 country: United States lat: 41.57721 lon: -93.71133 facility: Alliance for Multispec Res status: RECRUITING city: Newton state: Kansas zip: 67114 country: United States lat: 38.04668 lon: -97.34504 facility: Elite Research Center status: RECRUITING city: Flint state: Michigan zip: 48532 country: United States lat: 43.01253 lon: -83.68746 facility: Palm Research Center Inc. status: RECRUITING city: Las Vegas state: Nevada zip: 89128 country: United States lat: 36.17497 lon: -115.13722 facility: University of North Carolina status: NOT_YET_RECRUITING city: Chapel Hill state: North Carolina zip: 27517 country: United States lat: 35.9132 lon: -79.05584 facility: Clinical Research Associates status: RECRUITING city: Nashville state: Tennessee zip: 37203 country: United States lat: 36.16589 lon: -86.78444 facility: Velocity Clinical Res-Dallas status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States lat: 32.78306 lon: -96.80667 facility: Synergy Groups Medical status: RECRUITING city: Houston state: Texas zip: 77061 country: United States lat: 29.76328 lon: -95.36327 facility: PlanIt Research, PLLC status: RECRUITING city: Houston state: Texas zip: 77079 country: United States lat: 29.76328 lon: -95.36327 facility: Manassas Clinical Research Center status: RECRUITING city: Manassas state: Virginia zip: 20110 country: United States lat: 38.75095 lon: -77.47527 facility: TPMG Clinical Research status: RECRUITING city: Newport News state: Virginia zip: 23606 country: United States lat: 37.08339 lon: -76.46965 facility: Chinese People's Liberation Army General Hospital status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100853 country: China lat: 39.9075 lon: 116.39723 facility: The Second Affiliated Hospital of Nanjing Medical University_Nanjing status: NOT_YET_RECRUITING city: Nanjing state: Jiangsu zip: 210011 country: China lat: 32.06167 lon: 118.77778 facility: The Affiliated Hospital of Jiangsu University_Zhenjiang status: NOT_YET_RECRUITING city: Zhenjiang state: Jiangsu zip: 212001 country: China lat: 32.21086 lon: 119.45508 facility: Jinan Central Hospital status: NOT_YET_RECRUITING city: Ji'nan state: Shandong zip: 250013 country: China lat: 36.66833 lon: 116.99722 facility: Shanghai Pudong New Area People's Hospital status: NOT_YET_RECRUITING city: Shanghai state: Shanghai zip: 201200 country: China lat: 31.22222 lon: 121.45806 facility: Manda Memorial Hospital status: NOT_YET_RECRUITING city: Sapporo-shi, Hokkaido state: Hokkaido, Japan zip: 060-0062 country: Japan lat: 43.06667 lon: 141.35 facility: Tsuruma Kaneshiro Diabetes Clinic status: RECRUITING city: Yamato-shi state: Kanagawa zip: 242-0004 country: Japan facility: Kumanomae Nishimura Internal Medical Clinic status: RECRUITING city: Arakawa-ku, Tokyo zip: 116-0012 country: Japan facility: Akaicho Clinic status: RECRUITING city: Chiba-shi, Chiba zip: 260-0804 country: Japan facility: Futata Tetsuhiro Clinic Meinohama status: RECRUITING city: Fukuoka-shi, Fukuoka zip: 819-0006 country: Japan lat: 33.6 lon: 130.41667 facility: Kunisaki Makoto Clinic status: RECRUITING city: Fukuoka-shi, Fukuoka zip: 819-0168 country: Japan lat: 33.6 lon: 130.41667 facility: Sasaki Hospital Internal Medicine status: RECRUITING city: Hokkaido zip: 062-0007 country: Japan lat: 43.41104 lon: 142.88878 facility: Naka Kinen Clinic status: RECRUITING city: Ibaraki zip: 311-0113 country: Japan lat: 34.81641 lon: 135.56828 facility: H.E.C Science Clinic status: NOT_YET_RECRUITING city: Kanagawa zip: 235-0045 country: Japan lat: 37.58333 lon: 139.91667 facility: Minami Akatsuka Clinic status: RECRUITING city: Mito-shi, Ibaraki zip: 311-4153 country: Japan facility: Tokyo-Eki Center-building Clinic status: RECRUITING city: Tokyo zip: 103-0027 country: Japan lat: 35.6895 lon: 139.69171 facility: Tokyo-Eki Center-building Clinic status: NOT_YET_RECRUITING city: Tokyo zip: 103-0027 country: Japan lat: 35.6895 lon: 139.69171 facility: Fukuwa Clinic status: RECRUITING city: Tokyo zip: 104-0031 country: Japan lat: 35.6895 lon: 139.69171 facility: Kato Clinic of Internal Medicine status: RECRUITING city: Tokyo zip: 125-0054 country: Japan lat: 35.6895 lon: 139.69171 facility: Healthcare centre Zvezdara status: NOT_YET_RECRUITING city: Belgrade state: RS zip: 11050 country: Serbia lat: 44.80401 lon: 20.46513 facility: Healthcare centre Kragujevac status: NOT_YET_RECRUITING city: Kragujevac state: RS zip: 34000 country: Serbia lat: 44.01667 lon: 20.91667 facility: University Clinical Centre Nis status: NOT_YET_RECRUITING city: Nis state: RS zip: 18 000 country: Serbia lat: 43.32472 lon: 21.90333 facility: Healthcare centre Nis status: NOT_YET_RECRUITING city: Nis state: RS zip: 18000 country: Serbia lat: 43.32472 lon: 21.90333 facility: Policlinic for diabetes status: NOT_YET_RECRUITING city: Zajecar zip: 19000 country: Serbia lat: 43.90358 lon: 22.26405 facility: MOMED, s.r.o status: RECRUITING city: Kralovsky Chlmec zip: 077 01 country: Slovakia lat: 48.42336 lon: 21.97944 facility: DIA - KONTROL s.r.o. status: RECRUITING city: Levice zip: 93401 country: Slovakia lat: 48.21563 lon: 18.60705 facility: SIN AZUCAR s.r.o. status: RECRUITING city: Malacky zip: 901 01 country: Slovakia lat: 48.43604 lon: 17.02188 facility: ENRIN, s.r.o. status: RECRUITING city: Rimavska Sobota zip: 979 01 country: Slovakia lat: 48.38284 lon: 20.02239 facility: LUDIA, s.r.o. status: RECRUITING city: Spisska Nova Ves zip: 05201 country: Slovakia lat: 48.94464 lon: 20.56153 facility: Vuyo Clinical Research status: NOT_YET_RECRUITING city: Bloemfontein state: Free State zip: 9323 country: South Africa lat: -29.12107 lon: 26.214 facility: Lenasia Clinical Trial Centre status: NOT_YET_RECRUITING city: Lenasia state: Gauteng zip: 1827 country: South Africa lat: -26.32052 lon: 27.83564 facility: Prinshof Medical Campus status: NOT_YET_RECRUITING city: Pretoria state: Gauteng zip: 0002 country: South Africa lat: -25.74486 lon: 28.18783 facility: Clinical Trial Systems (CTC) status: NOT_YET_RECRUITING city: Pretoria state: Gauteng zip: 0186 country: South Africa lat: -25.74486 lon: 28.18783 facility: Ashmed Medi-Centre status: NOT_YET_RECRUITING city: Cape Town state: Western Cape zip: 7760 country: South Africa lat: -33.92584 lon: 18.42322 hasResults: False

 nctId: NCT06323148 id: ECTOP-1022 briefTitle: Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA Non-small Cell Lung Cancer (ECTOP-1022) overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-31 date: 2029-03-31 date: 2024-03-21 date: 2024-03-21 name: Fudan University class: OTHER briefSummary: This study plans to conduct ctDNA testing on EGFR mutation-positive stage II-IIIA (N1-N2) NSCLC patients after radical surgery (R0 resection). Patients with positive ctDNA testing will receive standard treatment according to clinical guidelines, while patients with negative ctDNA testing will be assessed based on comprehensive clinical and pathological characteristics. After receiving or not receiving standard adjuvant chemotherapy, patients will be randomly assigned in a 1:1 ratio to either the observation follow-up group (experimental group) or the osimertinib adjuvant treatment group (control group). The aim is to explore whether observation follow-up for patients with negative ctDNA after surgery has a prognosis non-inferior to osimertinib treatment, and to investigate the disease-free survival rate of EGFR mutation-positive stage II-IIIA (N1-N2) NSCLC patients with positive ctDNA after surgery receiving osimertinib adjuvant treatment, providing more precise treatment guidance for adjuvant therapy in this specific type of NSCLC patients with EGFR mutation-positive tumors. conditions: Lung Cancer conditions: EGFR Gene Mutation conditions: Minimal Residual Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 226 type: ESTIMATED name: Osimertinib name: No adjuvant therapy measure: The 3-year Disease-Free Survival (DFS) rate between the observation group and the osimertinib treatment group. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06323135 id: 2019-725 briefTitle: Nutrition Assessment in Advanced Cancer Patients overallStatus: COMPLETED date: 2019-09-17 date: 2023-09-11 date: 2023-09-11 date: 2024-03-21 date: 2024-03-21 name: West China Hospital class: OTHER briefSummary: The goal of this retrospective observational study is to evaluate the prognostic value of nutrition assessment tool in advanced cancers. We aim to evaluate the clinical utility of nutrition assessment tool in predicting the clinical outcomes of cancer patients, which would help the clinicians to make tailored decision for this population. conditions: Advanced Cancer conditions: Nutrition Aspect of Cancer conditions: Prognostic Cancer Model studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2115 type: ACTUAL measure: All-cause mortality measure: length of stay in hospital sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital, Sichuan Universit city: Chengdu state: Sichuan zip: 610041 country: China lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06323122 id: Plating Techniques 2023 briefTitle: A Comparative Study Between Three Different Plating Techniques in Management of Mandibular Parasymphyseal Fractures. overallStatus: COMPLETED date: 2021-01-01 date: 2023-10-01 date: 2023-12-01 date: 2024-03-21 date: 2024-03-21 name: October 6 University class: OTHER briefSummary: The main goal in management of mandibular fractures is to restore the pre-injury form and function, with the least disability and shortest recovery period. conditions: Mandibular Fractures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 60 type: ACTUAL name: 2.0 miniplates name: 2.3 high profile miniplates name: 3D miniplates measure: Surgery Time measure: complication measure: fracture stability sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: October 6U city: Cairo zip: 12566 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06323109 id: 2023-1331 id: A196200 type: OTHER domain: UW Madison id: Protocol Version 12/21/23 type: OTHER domain: UW Madison briefTitle: US Imaging for the Assessment of LUTS overallStatus: RECRUITING date: 2023-11-28 date: 2026-01-01 date: 2027-01-01 date: 2024-03-21 date: 2024-03-21 name: University of Wisconsin, Madison class: OTHER name: Wisconsin Partnership Program briefSummary: The purpose of this research is to develop an ultrasound (US) based urodynamics (UDS) evaluation of voiding based on successful magnetic resonance imaging (MRI)-UDS evaluation. Both US and MRI are non-invasive imaging techniques, but US is a more cost-effective and widely available technology. 80 participants will be enrolled and will be on study for up to 2.5 hours (1.5 hour MRI and 1 hour US). conditions: Lower Urinary Tract Symptoms conditions: BPH studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: MRI-UDS; US-UDS; MCUD measure: MRI Urodynamics - Change in Bladder Volume measure: MRI Urodynamics - Change in Urine Velocity measure: MRI Urodynamics - Change in Pressure measure: Bladder outlet obstruction index (BOOI) measure: Bladder contractility index (BOI) measure: International Prostate Symptom Score (IPSS) sex: MALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Wisconsin status: RECRUITING city: Madison state: Wisconsin zip: 53705 country: United States name: Gemma Gliori, MS role: CONTACT email: ggliori@uwhealth.org name: Suzanne Hanson, BS role: CONTACT email: shanson@uwhealth.org name: Alejandro Roldan-Alzate, PhD role: PRINCIPAL_INVESTIGATOR name: Wade Bushman, MD, PhD role: SUB_INVESTIGATOR name: Matt Grimes, MD role: SUB_INVESTIGATOR name: Giuseppe Toia, MD role: SUB_INVESTIGATOR name: Ivan Rosado-Mendez, PhD role: SUB_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06323096 id: AR13067824 briefTitle: Development of Clinical Decision Support System for Severe Patients With Polytrauma overallStatus: RECRUITING date: 2020-12-01 date: 2024-09-01 date: 2024-12-31 date: 2024-03-21 date: 2024-03-21 name: Semey State Medical University class: OTHER name: Ministry of Science and Higher Education of the Republic of Kazakhstan briefSummary: The goal of this observational study is to develop a Clinical Decision Support System for severe patients with polytrauma. The main questions it aims to answer are:

* Is it possible to predict the development of systemic inflammatory response syndrome for the next 24 h after admission?
* Is it possible to predict the development of blood loss \>25% of blood volume for the next 24 h after admission?
* Is it possible to predict the development of acute traumatic coagulopathy for the next 24 h after admission?
* Is it possible to predict the development of pneumonia in polytrauma patients?
* Is it possible to predict the outcome in polytrauma patients?

No intervention is planned for this study. conditions: Polytrauma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 500 type: ESTIMATED measure: Prediction of SIRS measure: Rate of ATC prediction in the 24 h after admission using the developed CDSS. measure: Rate of hemorrage prediction in the 24 h after admission using the developed CDSS. measure: Rate of pneumonia prediction using the developed CDSS. sex: ALL minimumAge: 28 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emergency Hospital status: RECRUITING city: Semey state: Abai zip: 071400 country: Kazakhstan name: Alexander Prokazyuk, MD role: CONTACT phone: +77071891849 email: prokazyuk.md@yandex.ru lat: 50.42675 lon: 80.26669 hasResults: False

 nctId: NCT06323083 id: 006 briefTitle: The Effect of Emotional Freedom Technique on Perceived Stress and General Self-Efficacy in Nursing Students overallStatus: COMPLETED date: 2022-11-07 date: 2022-11-28 date: 2023-06-30 date: 2024-03-21 date: 2024-03-21 name: Selcuk University class: OTHER briefSummary: The study was conducted to determine the effect of Emotional Freedom Technique (EFT) on perceived stress and general self-efficacy in obstetrics and gynecology nursing lesson in undergraduate nursing students with fear of birth.

The samples were applied to undergraduate nursing students satisfying the research criteria in a state university nursing faculty in Konya at November 2022. conditions: Emotion Regulation conditions: Stress conditions: Self Efficacy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study was designed to be randomly controlled. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ACTUAL name: Emotional Freedom Technique measure: General Self-Efficacy Scale measure: Perceived Stress Scale measure: The Subjective Units of Distress Scale sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Selcuk University city: Konya country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06323070 id: HS-2023-0281 briefTitle: Effects of Watermelon or Low-fat Cookie Consumption on Wellness overallStatus: RECRUITING date: 2024-03-01 date: 2025-12 date: 2025-12 date: 2024-03-21 date: 2024-03-22 name: San Diego State University class: OTHER briefSummary: The objective of the proposed research is to determine the effects of fresh watermelon consumption on physiological indicators of wellness regarding sexual, skin and gut health in adults. conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: Low-fat cookies name: Watermelon measure: Change of sexual health questionnaire scores measure: Change of skin hydration scores measure: Change of microbiome diversity measure: Change of depression questionnaire scores sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: School of Exercise and Nutritional Sciences status: RECRUITING city: San Diego state: California zip: 92182 country: United States name: Mee Young Hong, PhD role: CONTACT phone: 619-594-2392 email: mhong2@sdsu.edu lat: 32.71533 lon: -117.15726 hasResults: False

 nctId: NCT06323057 id: Pro2022000444_CLFMT briefTitle: Modulating Reward Learning Using Transcranial Magnetic Stimulation overallStatus: RECRUITING date: 2024-02-14 date: 2025-04-30 date: 2025-04-30 date: 2024-03-21 date: 2024-03-22 name: Rutgers, The State University of New Jersey class: OTHER briefSummary: Our specific aim is to examine the effects of TMS on reward processing during goal-directed behavior. In these experiments the investigators will utilize a scalp-recorded brain oscillation called frontal midline theta that is believed to index the sensitivity of the cingulate cortex to reward feedback. Here the investigators will asked whether this electrophysiological signal can be modulated up or down using TMS while participants engage in decision making tasks, and if so, whether it would affect the encoding of rewards and subsequent choices during task performance. conditions: Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Participants will be blinded to the TMS condition (active or sham) whoMasked: PARTICIPANT count: 28 type: ESTIMATED name: Single pulse TMS to the frontal cortex measure: Event-related Brain Oscillation: Frontal Midline Theta measure: Reward learning sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Rutgers University - Newark status: RECRUITING city: Newark state: New Jersey zip: 07102 country: United States name: Travis E Baker, PhD role: CONTACT phone: 862-250-3351 email: travis.e.baker@rutgers.edu name: Daniel Robles, PhD role: CONTACT phone: 973-353-3509 email: dr1147@newark.rutgers.edu lat: 40.73566 lon: -74.17237 hasResults: False

 nctId: NCT06323044 id: I-3920723 id: NCI-2024-01734 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: I-3920723 type: OTHER domain: Roswell Park Cancer Institute id: R01CA283501 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA283501 briefTitle: MedSupport Intervention to Identify and Address Barriers to Pediatric Medication Adherence overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2029-06-15 date: 2029-06-15 date: 2024-03-21 date: 2024-04-03 name: Roswell Park Cancer Institute class: OTHER briefSummary: This clinical trial identifies and addresses barriers to pediatric medication adherence among families of children with acute lymphoblastic leukemia. Pediatric nonadherence (noncompliance) to medication is a significant public health problem, and rigorous research repeatedly documents that nonadherence increases risk for hospitalization, healthcare cost, disease progression, and death. Pediatric acute lymphoblastic leukemia (ALL) patients who miss 5% of 6-mercaptopurine (6-MP) doses within the 2-year 6-MP regimen have a 2.7-fold risk of cancer that comes back after a period of improvement (relapse). To address these families' needs, researchers have developed MedSupport, a theory-based multilevel intervention with targets at the organizational, healthcare team, and caregiver levels that is designed to address root barriers to medication adherence. This study is being done to better understand families' experiences giving their child oral chemotherapy at home and to help families cope with the day-to-day challenges of giving their child medication. conditions: Acute Lymphoblastic Leukemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ESTIMATED name: Best Practice name: Biospecimen Collection name: Electronic Health Record Review name: Interview name: Medical Device Usage and Evaluation name: Medical Device Usage and Evaluation name: Survey Administration measure: Medication adherence sex: ALL minimumAge: 365 Days stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Roswell Park Cancer Institute city: Buffalo state: New York zip: 14263 country: United States name: Kara M. Kelly role: CONTACT phone: 716-845-2333 email: Kara.Kelly@RoswellPark.org name: Kara M. Kelly role: PRINCIPAL_INVESTIGATOR lat: 42.88645 lon: -78.87837 hasResults: False

 nctId: NCT06323031 id: Blink-DoC briefTitle: Spontaneous Eye Blinking in Disorders of Consciousness acronym: Blink-DoC overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-11 date: 2024-03-21 date: 2024-03-21 name: Fondazione Don Carlo Gnocchi Onlus class: OTHER name: Therapiezentrum Burgau name: University of Liege name: University Hospital Munich name: VITHAS Valencia (Spain) name: Azienda Ospedaliera Universitaria Ferrara name: Ludwig-Maximilians - University of Munich briefSummary: Differential diagnosis between Unresponsive Wakefulness Syndrome (UWS) and Minimally Conscious State (MCS) is complicated due to severe cognitive and/or sensorimotor deficits in these patients. In this study the investigators aimed at exploring the diagnostic and prognostic validity of spontaneous eye blinking parameters (rate, amplitude, duration, variability) in a sample of patients with Disorders of Consciousness (DoC).

This is a multi-center prospective observational study conducted in patients with Severe Acquired Brain Injury (sABI) and DoC admitted to 8 European participating centers, with clinical data collection not deviating from routine practice. The study is non-commercial and will have a maximum total duration of 24 months. conditions: Disorders of Consciousness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 70 type: ESTIMATED measure: Clinical Diagnosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Coma Science Group, GIGA-Consciousness, University of Liege city: Liege zip: 4000 country: Belgium name: Olivia Gosseries, PhD role: CONTACT email: ogosseries@uliege.be name: Olivia Gosseries, PhD role: PRINCIPAL_INVESTIGATOR name: Aurore Thibaut, PhD role: SUB_INVESTIGATOR name: Youssra Mezoudi, M.Sc. role: SUB_INVESTIGATOR lat: 50.63373 lon: 5.56749 facility: Therapiezentrum Burgau city: Burgau zip: 89331 country: Germany name: Andreas Bender, MD role: CONTACT email: a.bender@therapiezentrum-burgau.de name: Andreas Bender, MD role: PRINCIPAL_INVESTIGATOR name: Martin Rosenfelder, PhD role: SUB_INVESTIGATOR lat: 48.43159 lon: 10.40989 facility: Dipartimento di Neurologia, LMU Hospital, LMU Munich city: Munich zip: 81377 country: Germany name: Konstantinos Dimitriadis role: CONTACT email: konstantin.dimitriadis@med.unimuenchen.de name: Konstantinos Dimitriadis role: PRINCIPAL_INVESTIGATOR name: Moritz Schmidbauer role: SUB_INVESTIGATOR name: Julia Zibold role: SUB_INVESTIGATOR lat: 48.13743 lon: 11.57549 facility: Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS city: Sant'Angelo dei Lombardi state: AV zip: 83054 country: Italy name: Anna Estraneo, PhD role: CONTACT phone: 3396418648 phoneExt: 39 email: aestraneo@dongnocchi.it name: Alfonso Magliacano, PhD role: CONTACT phone: 3387389414 phoneExt: 39 email: amagliacano@dongnocchi.it name: Anna Estraneo, MD role: PRINCIPAL_INVESTIGATOR name: Alfonso Magliacano, PhD role: SUB_INVESTIGATOR name: Giovanni Scarano, BS role: SUB_INVESTIGATOR lat: 40.92937 lon: 15.17535 facility: Unità Gravi Cerebrolesioni - Dipartimento Neuroscienze - Azienda Ospedaliera - Universitaria Ferrara city: Ferrara zip: 44124 country: Italy name: Susanna Lavezzi role: CONTACT email: s.lavezzi@ospfe.it name: Susanna Lavezzi role: PRINCIPAL_INVESTIGATOR name: Valentina Bonsangue role: SUB_INVESTIGATOR name: Sofia Straudi role: SUB_INVESTIGATOR lat: 44.83804 lon: 11.62057 facility: IRCCS Fondazione Don Gnocchi ONLUS city: Florence zip: 50143 country: Italy name: Bahia Hakiki, PhD role: CONTACT email: bhakiki@dongnocchi.it name: Bahia Hakiki, PhD role: PRINCIPAL_INVESTIGATOR name: Andrea Mannini, PhD role: SUB_INVESTIGATOR name: Piergiuseppe Liuzzi, PhD role: SUB_INVESTIGATOR lat: 43.77925 lon: 11.24626 facility: IRCCS Santa Maria Nascente Fondazione Don Gnocchi ONLUS city: Milan zip: 20148 country: Italy name: Angela Comanducci, PhD role: CONTACT email: acomanducci@dongnocchi.it name: Angela Comanducci, PhD role: PRINCIPAL_INVESTIGATOR name: Tiziana Atzori role: SUB_INVESTIGATOR name: Chiara-Camilla Derchi role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: Instituto de Rehabilitación Neurológica IRENEA city: Valencia zip: 46007 country: Spain name: Enrique Noé, MD role: CONTACT email: enoe@comv.es name: Enrique Noé, MD role: PRINCIPAL_INVESTIGATOR name: Roberto Llorens, PhD role: SUB_INVESTIGATOR name: Alejandro Galvao, PhD role: SUB_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06323018 id: 384T-26 briefTitle: Effects of Remote Ischaemic Preconditioning in Cemented Hip Arthroplasty. acronym: PRINCIPAL overallStatus: RECRUITING date: 2024-03-20 date: 2026-03 date: 2027-03 date: 2024-03-21 date: 2024-04-04 name: University of Tartu class: OTHER briefSummary: Total joint arthroplasty is one of the best treatment options for end-stage osteoarthritis. Cemented hip arthroplasty is mainly indicated for elderly patients with poor bone quality and multiple comorbidities. Bone cement implantation syndrome is associated with cemented hip arthroplasty and it has been shown to increase cardiovascular and renal complication and brain damage postoperatively. The aim of this project is to elucidate whether remote-ischemic preconditioning (RIPC) has multi-organ protective effect in cemented hip arthroplasty patients. conditions: Osteoarthritis, Hip conditions: Cardiovascular Diseases conditions: Bone Cement Implantation Syndrome conditions: Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Randomization and intervention is done by a dedicated study nurse. Patient, orthopedic surgeon, investigator and outcomes assessor and statistician are all blinded to the study intervention. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Remote Ischemic Preconditioning name: SHAM measure: Myocardial injury measure: Cardiovascular injury measure: Clinical serious complications measure: Carotid-femoral pulse velocity measure: Augmentation index measure: Brain injury measure: Kidney Injury measure: Total antioxidative capacity (TAC) measure: Oxidative stress level (total peroxide levels) measure: Inflammation level measure: Low molecular weight metabolites (uM) sex: ALL minimumAge: 65 Years maximumAge: 90 Years stdAges: OLDER_ADULT facility: University of Tartu status: RECRUITING city: Tartu state: Tartumaa zip: 50406 country: Estonia name: Kaspar Tootsi, MD, PhD role: CONTACT phone: +3727318282 email: kaspar.tootsi@kliinikum.ee lat: 58.38062 lon: 26.72509 hasResults: False

 nctId: NCT06323005 id: 2024-0024 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-03-21 date: 2024-04-18 name: [Redacted] hasResults: False

 nctId: NCT06322992 id: R41CA271962 type: NIH link: https://reporter.nih.gov/quickSearch/R41CA271962 briefTitle: App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic Toxicity in Cancer Patients - Aim 3 overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-05 date: 2025-05 date: 2024-03-21 date: 2024-03-22 name: Daynamica, Inc. class: INDUSTRY name: Masonic Cancer Center, University of Minnesota briefSummary: The goal of this observational study is to develop a mobile app for cancer patients undergoing treatments. In Aim 3, patients will rate the quality of the app using the Mobile App Rating Scale (MARS) and their satisfaction with the three key app features. The outcome of this project will be a final prototype app with 70% of patients indicating an overall MARS score of 4.0 or more and satisfaction with the three features. conditions: Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: APP satisfaction measure: APP rating sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06322979 id: # R-PED-11-23-3074 briefTitle: Premixed Bioceramic Putty as an Apical Plug in Immature Anterior Permanent Teeth overallStatus: RECRUITING date: 2023-11-22 date: 2024-11 date: 2024-12 date: 2024-03-21 date: 2024-03-21 name: Tanta University class: OTHER briefSummary: Following the randomization procedure, children will be divided into 2 groups (25 immature anterior permanent incisors in each group): Group I will be treated with MTA as apical plug while group II will be treated with Premixed Bioceramic Putty as apical plug. After working length determination, instrumentation, and irrigation of the root canals, apical plug will be done. in MTA Group, MTA will be placed into the apical 4 mm of root canals, then a moist cotton pellet will be placed and the access cavity will be restored with glass-ionomer-based restoration. Next day, glass-ionomer-based restoration and the cotton pellet will be removed, then the coronal restoration will be completed with GIC, composite. In the Premixed Bioceramic Putty group, Well-Root™ PT will be placed into the apical 4 mm of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite.

children will be recalled for clinical and radiographical follow-up after 6 and12 months after treatment. conditions: Periapical Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Mineral trioxide aggregate name: Premixed Bioceramic Putty measure: the clinical success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA) measure: the radiographic success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA) measure: Change in the periapical index (PAI) sex: ALL minimumAge: 8 Years maximumAge: 11 Years stdAges: CHILD facility: Tanta University status: RECRUITING city: Tanta state: Gharbia zip: 6624033 country: Egypt name: Shaimaa eldesouky, PhD role: CONTACT phone: 01008994242 email: shiamaaeldesouky@dent.tanta.edu.eg name: mohamed ghaly, PhD role: CONTACT phone: 01098472899 lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06322966 id: STUDY00017745 id: K99ES034442 type: NIH link: https://reporter.nih.gov/quickSearch/K99ES034442 briefTitle: Learning and Living With Wildfire Smoke overallStatus: RECRUITING date: 2023-09-04 date: 2027-05-28 date: 2028-05-26 date: 2024-03-21 date: 2024-03-21 name: University of Washington class: OTHER name: National Institute of Environmental Health Sciences (NIEHS) briefSummary: The proposed intervention in this Youth Participatory Action Research (YPAR) proposal will improve knowledge and awareness of the health impacts of air pollution exposure, will elevate the youth voice, improve youth self-efficacy and lead to behavior changes that would reduce exposure to air pollution in a high school setting. These outcomes will be accomplished through the introduction of a new air quality curriculum, called AirActions, into freshman science classes, and the establishment of an after-school air quality monitoring program.

All students enrolled in freshman Honors Biology (Pueblo East and Montrose High Schools), Intro to Agriculture (The STEAD School) and Environmental Science (Grand Junction High School) will participate in the new air quality curriculum, as it will be built into the existing lesson plans. For the after-school monitoring program, the PI and participating teachers (Letters A and B) will recruit 10 to 15 students at each school to be involved in the Student Research Cohort (SRC). Information on this program and how to apply will be shared with students through their health and science classes, included in the school newsletter, and posted on billboards around the school. Students will be identified within the following inclusion criteria: 1) freshman or sophomores in high school and 2) participation in the AirActions curriculum. New students will be recruited each year to keep a consistent group as students leave and/or graduate. New students will be brought up to speed by carry-over students, and each new year will represent a separate SRC dedicated to a specific goal. conditions: Behavior and Behavior Mechanisms conditions: Health Knowledge, Attitudes, Practice studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 400 type: ESTIMATED name: Air Action Curriculum measure: Number of students, staff, teacher and administrators with higher scores on a Likert-style questionnaire for content knowledge learning objectives. measure: Scores on Likert-style questionnaire to evaluate behavior change around air quality. measure: Change in student exposure to air pollution calculated through measurements of indoor particulate matter and indoor carbon dioxide. sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Washington status: RECRUITING city: Seattle state: Washington zip: 98195 country: United States name: Savannah M D'Evelyn, PhD role: CONTACT phone: 303-501-6656 email: sdevelyn@uw.edu lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06322953 id: RG442-21 briefTitle: Timing to Restart Direct Oral Anticoagulants After Traumatic Intracranial Haemorrhage acronym: RESTARTtlCrH overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-12-31 date: 2028-07-31 date: 2024-03-21 date: 2024-03-22 name: Walton Centre NHS Foundation Trust class: OTHER name: University of Liverpool name: National Institute for Health Research, United Kingdom briefSummary: Older people falling from a standing height is the most common cause of hospital admission for head injury. Up to 1 in 3 patients admitted are taking a tablet medication which thins the blood, known as an oral anticoagulant. This type of medication can increase the likelihood of bleeding in the brain. Many patients are taking oral anticoagulation due to having an irregular heartbeat (called atrial fibrillation) or because of having a previous stroke or blood clots. When a scan shows blood in the brain, oral anticoagulation is nearly always stopped. However, this leaves the question of when it is safe to restart them. The risk of making the bleeding in the brain worse must be balanced against the risk of having a stroke or blood clots. There is no clear evidence on the safest time to restart oral anticoagulation, but most neurosurgeons advise restarting them 1-4 weeks after head injury. The number of people who have a bleed on their brain after a head injury is increasing and further brain bleeding or a stroke can have a serious effect on patients' lives and their on-going healthcare needs. Public and patient groups have highlighted that many patients want to stop taking oral anticoagulation after a bleed but they may be unaware of the vital importance of restarting this medication to prevent strokes and blood clots. The most popular oral anticoagulation prescribed has changed in recent years from warfarin to newer medications called Direct Oral Anti-Coagulants (DOACs).

This trial will recruit 1084 people who are admitted to hospital with a bleed on the brain caused by a head injury who were taking oral anticoagulation before their head injury and have been prescribed a Direct Oral Anti-Coagulant (DOAC) for previously diagnosed medical condition. Patients on other Oral Anti-Coagulants, such as Warfarin may also be able to take part. The main purpose of the trial is to determine when is most beneficial time for people to start or restart a DOAC after their head injury. People will be asked to start the medication either 1 week or 4 weeks after their head injury. They will be then followed closely for 12 weeks and any major bleeding events or a blood clots (thrombotic events) such as a stroke or heart attack will be recorded. The study will also look at the person's overall quality of life, how they recover physically, the number of people who die, the costs of the treatment, and the attitudes of people and their caregivers to starting or restarting a DOAC. conditions: Traumatic Intracranial Haemorrhage studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised Controlled Trial primaryPurpose: TREATMENT masking: NONE count: 1084 type: ESTIMATED name: Direct-Acting Oral Anticoagulants (used as per local standard practice) measure: Proportion of patients with haemorrhagic or thrombotic event within 12 weeks following tICrH. measure: Time to first haemorrhagic or thrombotic event. measure: Time to first haemorrhagic event measure: Time to first thrombotic event measure: Time to death measure: Functional outcome measured using modified Rankin Scale (mRS) measure: Functional outcome measured using Barthel Index measure: Functional outcome measured using extended Glasgow Outcome Scale (GOS-E) measure: Overall Quality of Life measured by EuroQol 5 Dimensions 5 Levels (EQ5D5L) questionnaire measure: Patient/caregiver attitudes to (re)starting OAC measure: Healthcare resource use sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06322940 id: 2024-10463 briefTitle: Effect of Dairy Product Matrices on Insulin Resistance in People With Overweight and Obesity and Prediabetes overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-09-01 date: 2026-12-31 date: 2024-03-21 date: 2024-03-21 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER name: Dairy Farmers of Canada briefSummary: The objective of the study is to determine the effect of dairy product matrices on insulin sensitivity in overweight and obese adults with prediabetes. Females and males (30-65 y) will be recruited from the greater Montreal area. Upon screening, those with prediabetes will complete a 2-wk run-in period in which participants will consume 1 serving/d of regular-fat dairy products (milk, yogurt, or cheese). Adherent participants will be randomized by sex into 1 of 3 groups: ≤1 serving/d of dairy (limited dairy) or 2-3 servings/d of reduced-fat or regular-fat dairy for 12 weeks. Participants will be instructed on how to incorporate foods into their diet to prevent changes in their body weight. The hyperinsulinemic-euglycemic clamp will be used before and after the intervention to document potential changes in insulin sensitivity as the primary outcome. In addition, glycemic variables, body composition, and cardiometabolic risk factors will be assessed as secondary outcomes. Adherence to intervention will be assessed at each visit by food diaries and a record of consumed dairy products. conditions: PreDiabetes conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Three treatment groups primaryPurpose: OTHER masking: DOUBLE maskingDescription: Participant's study group will be coded. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: 250 mL serving size, 3.25% fat content name: 175 g serving size, ≥2% fat content name: 50 g serving size, ≥28% fat content measure: Change in whole-body insulin sensitivity measure: Change in glucose tolerance measure: Change in Matsuda index measure: Change in Insulinogenic index measure: Change in oral disposition index measure: Change in Homeostatic Model Assessment for Insulin Resistance measure: Change in glycated hemoglobin measure: Change in total lean body mass measure: Change in total fat mass measure: Change in visceral fat mass measure: Change in systolic blood pressure measure: Change in diastolic blood pressure measure: Change in lipid profile measure: Change in resting energy expenditure measure: Change in total energy expenditure measure: Change in metabolic equivalent of task measure: Change in total energy intake sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RI-MUHC city: Montréal state: Quebec zip: H4A 3J1 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06322927 id: CFTsp231 id: 24_CPCR_38 type: OTHER domain: ChristieNHS briefTitle: PatIent exPeRiences and prEFerence of trEatment foR Multiple Myeloma acronym: iPREFER overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2024-06-30 date: 2024-09-30 date: 2024-03-21 date: 2024-03-21 name: The Christie NHS Foundation Trust class: OTHER name: CellCentric Ltd. briefSummary: This is a qualitative (interview) study to explore the experiences of people receiving treatment for MM and to understand what matters most to them when making treatment decisions. conditions: Multiple Myeloma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 15 type: ESTIMATED name: Patient Interview measure: Patient Experience and Preference measure: Treatment and Preference Differences sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Christie NHS Foundation Trust city: Manchester state: Greater Manchester zip: M20 4BX country: United Kingdom lat: 53.48095 lon: -2.23743 hasResults: False

 nctId: NCT06322914 id: 029 briefTitle: A Novel Scoring System for Predicting the Success of PCI in Patients With CTO overallStatus: COMPLETED date: 2012-01 date: 2023-11 date: 2023-11 date: 2024-03-21 date: 2024-03-21 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: The investigators conducted a retrospective, single-center observational registry upon which one novel scoring system was formed and evaluated for their accuracy in predicting technical success. The investigators reviewed the clinical and angiographic records of 432 patients with 459 CTO lesions who underwent percutaneous recanalization attempts recruited between January 2012 and November 2023. The investigators aims to develop and validate a novel scoring system for predicting CTO-PCI success. conditions: Chronic Total Occlusion (CTO) studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 493 type: ACTUAL measure: PCI technical success sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210029 country: China lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06322901 id: TDH-2018-7883 briefTitle: The Effect Of Vertical Releasing Incision On Implant Procedures acronym: Vertikal overallStatus: COMPLETED date: 2018-08-05 date: 2020-10-02 date: 2020-10-02 date: 2024-03-21 date: 2024-03-21 name: TC Erciyes University class: OTHER briefSummary: This study evaluated the clinical and biochemical aspects of flap design in dental implant applications regarding implantation success and patient comfort. In this split-mouth randomized controlled clinical trial, a vertical releasing incision was made at the distal end of the crestal incision on the test side, and the control side received a crestal incision alone. Sixty-eight implants were placed in 17 patients. Peri-implant groove fluid was collected on postsurgical days 3, 7, 30, and 90; OPG and RANKL levels were assessed to determine bone formation and resorption around the implants. Cortisol levels were assessed in peri-implant groove fluid at postsurgical days 3, 7, and 14. Visual analog scale (VAS), and swelling measurements were taken postoperatively. Panoramic and periapical X-rays were obtained immediately post-surgery and at 3 months. No significant marginal bone loss difference was observed between the test and control sides at 3 months. The RANKL/OPG ratio, cortisol levels, VAS scores, and swelling scores were higher in the test vs. control sides. Overall, while the use of a vertical incision has advantages, such as increasing the visual field of the surgeon and improving the ease of the operation, this approach should be used only when necessary, given the disadvantages of increased bone resorption mediators in the peri-implant tissue and reduced postoperative patient comfort. conditions: Bone Loss conditions: Flap Design studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 17 type: ACTUAL name: Flap measure: Bone loss measure: OPG/RANKL measure: visual analog scale (VAS) measure: cortisol levels sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erciyes University Faculty of Dentistry city: Melikgazi state: Kayseri zip: 38039 country: Turkey hasResults: False

 nctId: NCT06322888 id: 23-676 briefTitle: Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-09-30 date: 2025-12-31 date: 2024-03-21 date: 2024-03-21 name: Dana-Farber Cancer Institute class: OTHER name: Breast Cancer Research Foundation briefSummary: The goal of this study is to learn more about how exercise might lower the risk of developing breast cancer in women with dense breast tissue by studying changes that occur in breast tissue and blood as a result of participating in an exercise program.

The names of the study groups in this study are:

* Exercise Training Group
* Waitlist Control Group conditions: Breast Cancer conditions: Breast Cancer Female studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 46 type: ESTIMATED name: Exercise Training Program measure: Change in Irisin in Exercise Group measure: Change in Irisin in Control Group measure: Change in Tissue Markers in Exercise Group measure: Change in Tissue Markers in Control Group measure: Change in Biomarkers in Exercise Group - Meso scale measure: Change in Biomarkers in Exercise Group - Mass cytometry measure: Change in Biomarkers in Control Group - Meso Scale measure: Change in Biomarkers in Control Group - Mass cytometry measure: Change in Participant Weight in Exercise Group measure: Change in Participant Weight in Control Group measure: Change in Cardiorespiratory Fitness in Exercise Group measure: Change in Cardiorespiratory Fitness in Control Group measure: 10-Repetition Max Test in Exercise Group measure: 10-Repetition Max Test in Control Group measure: Change in Minutes of Total Exercise for Exercise Group measure: Change in Minutes of Total Exercise for Control Group sex: FEMALE minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02115 country: United States name: Tari King, MD role: CONTACT phone: 617-632-3891 email: tking7@bwh.harvard.edu name: Tari King, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Dana Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States name: Jennifer Ligibel, MD role: CONTACT phone: 617-632-3800 email: Jennifer_Ligibel@dfci.harvard.edu name: Jennifer Ligibel, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06322875 id: SKCCOL002 briefTitle: A Clinical Study to Evaluate the Efficacy and Satisfaction of RHC Serum Combined With RHC(III) Injection overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-07 date: 2024-12 date: 2024-03-21 date: 2024-03-21 name: DeYi Aesthetic Medical Clinic class: OTHER briefSummary: To evaluate the efficacy and safety of recombinant humanized collagen (type III) solution for injection combined with SkinCeuticals recombinant humanized collagen (RHC) serum Participants will be assessed by subjective questionnaire (FACE-Q Satisfaction with skin,Global Aesthetic Improvement Scale, et al) and some medical instruments (VISIA,Ultrascan UC22 et al) conditions: Facial Wrinkles studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Recombinant type III humanized collagen solution for injection name: SkinCeuticals recombinant humanized collagen (RHC) serum name: Regular face cream smear measure: FACE-Q Satisfaction with skin measure: Investigator Global Aesthetic Improvement Scale (I-GAIS) Rates measure: Subject Global Aesthetic Improvement Scale (S-GAIS) Rates measure: Improvement rate assessed by Atlas measure: Change in Cutometer® dual Analysis Score measure: Change in VISIA® Skin Analysis Score measure: FACE-Q Satisfaction with Outcome measure: FACE-Q Satisfaction with skin measure: Change of the thickness and density of subjects' facial dermis measure: Changes from baseline in skin uniformity and spot area ratio measurements collected by VISIA's face image acquisition instrument. sex: FEMALE minimumAge: 30 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06322862 id: H-23042430 briefTitle: Intraoperative Intestinal Perfusion Assessment by Fluorescence Angiography in Emergency Surgery overallStatus: RECRUITING date: 2024-03-05 date: 2026-12-01 date: 2027-02-01 date: 2024-03-21 date: 2024-03-21 name: Rigshospitalet, Denmark class: OTHER briefSummary: This is a prospective, multicentre, non-randomized cohort study using real-time intraoperative visualization of bowel perfusion by indocyanine green (ICG) in all-cause bowel ischemia.

At intraoperative finding of bowel ischemia, the initial intraoperative plan is noted and resection margins marked with a steril pen. A fluorescence angiography will be performed and the surgeon will note whether the suspected ischemic bowel is perfused, whether there is a change in the resection margins in centimeters, and if the intraoperative plan has changed. If resection is indicated and the strategy of choice is an anastomosis, a renewed fluorescence angiography will be performed to assess anastomotic perfusion. conditions: Bowel; Ischemic, Acute studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: Indocyanine green measure: Change of strategy measure: Anastomosis measure: Quantification using q-ICG measure: Stomas measure: Second-look measure: Anastomotic leaks measure: Postoperative medical complications measure: Postoperative surgical complications measure: Mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Organ Surgery and Transplantation status: RECRUITING city: Copenhagen state: Hovedstaden zip: 2100 country: Denmark name: Sermed Ellebæk Nicolae, MD role: CONTACT phone: +4535459666 email: sermed.ellebaek.nicolae@regionh.dk name: Michael P Achiam, MD, DMSc role: CONTACT phone: +45 3545 0441 email: michael.patrick.achiam.01@regionh.dk lat: 55.67594 lon: 12.56553 facility: Department of Surgery, Bispebjerg Hospital status: NOT_YET_RECRUITING city: Bispebjerg country: Denmark name: Peter Bonde, MD role: CONTACT lat: 55.71017 lon: 12.53147 facility: Department of Surgery, Herlev Hospital status: NOT_YET_RECRUITING city: Herlev country: Denmark name: Jakob Burcharth, MD, PhD role: CONTACT lat: 55.72366 lon: 12.43998 facility: Department of Surgery, Nordsjællands Hospital status: NOT_YET_RECRUITING city: Hillerød country: Denmark name: Mai-Britt Tolstrup, MD, PhD role: CONTACT lat: 55.92791 lon: 12.30081 facility: Department of Surgery, Hvidovre Hospital status: NOT_YET_RECRUITING city: Hvidovre country: Denmark name: Morten Laksafoss Lauritsen, MD role: CONTACT lat: 55.65719 lon: 12.47364 hasResults: False

 nctId: NCT06322849 id: STU00220591 briefTitle: Active Elements of Digital Single-session Interventions overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-06 date: 2024-03-21 date: 2024-04-11 name: Northwestern University class: OTHER briefSummary: Depression is a leading cause of disability in young adults. However, access to care is limited due to structural and psychological barriers. Single-session interventions (SSIs) are structured programs designed to maximize the therapeutic output in one interaction between the patient and the provider or a program. Project ABC, a single-session intervention (SSI), has been shown to be effective in reducing depressive symptoms. Project ABC is based on four components-psychoeducation, testimonials, saying is believing exercises, and action planning. However, it is unclear what are the effects of the individual components.

The primary aim of this study is to calculate the main effects of the candidate components-psychoeducation, testimonials + saying is believing exercises, and action planning-on Patient Health Questionnaire-8 (PHQ-8) scores at 8-week follow-up.

The secondary aims of this study are to:

1. calculate the main effects of the candidate components-psychoeducation, testimonials + saying is believing exercises, and action planning-on PHQ-8 scores at immediate post-treatment and 2-week follow-up.
2. calculate the interaction effects, if any, among the candidate components on PHQ-8 scores at immediate post-treatment, 2-week, and 8-week follow-up.
3. calculate the main and interaction effects of the candidate components on measures of hopelessness, autonomy, relatedness, and competence.
4. determine if the effects of the candidate components on PHQ-8 are mediated by measures of autonomy, relatedness, and competence.

Additionally, the exploratory aim of this study is to determine if common factors, like credibility of the intervention and expectations to improve, can lead to symptom change. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Participants will be randomized to one of 8 different conditions (factorial trial), following the Multiphase optimization Strategy (MOST) primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants will be aware that they will be assigned to an intervention designed to help them with depressive symptoms. Participants will be aware that there are other arms of the study to which other participants are randomized, but they will not be aware of what these other arms entail. Additionally, the measures will be self-administered, so there is no scope for evaluator bias. whoMasked: PARTICIPANT count: 880 type: ESTIMATED name: Psychoeducation name: Testimonials and Saying is believing exercises name: Action planning name: Breathing exercise measure: Patient Health Questionnaire-8 measure: Patient Health Questionnaire-8 measure: Beck Hopelessness Scale-4 measure: Balanced measure of Psychological Needs scale measure: Credibility/Expectancy questionnaire measure: Intervention satisfaction star rating at post-intervention sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06322836 id: Protocol ID ABR number 83536 briefTitle: A Feasibility Study for Elective Cardioversion of Atrial Fibrillation at Home acronym: Electra-1 overallStatus: ENROLLING_BY_INVITATION date: 2024-02-07 date: 2024-06-01 date: 2024-06-01 date: 2024-03-21 date: 2024-03-21 name: RAV Brabant MWN class: OTHER name: Jeroen Bosch Ziekenhuis briefSummary: The goal of this pilot, non-controlled, non-randomised, single centre, prospective intervention feasibility study is to assess the feasibility of a home DC-ECV in the treatment of recurrent symptomatic AF performed by APP in 25 patients.

The main question\[s\] it aims to answer are:

Primary objective:

In this prospective intervention feasibility study, in 25 patients the primary endpoint is completion of cardioversion to sinus rhythm. (% of study patients with a recurrence of AF in whom a home cardioversion is performed, i.e. to whom at least one DC shock was administered while the patient was under sedation).

Feasibility endpoints are ; (a) evaluation of enrolment of participants, (b) evaluation and refinement of data and outcome collection procedures, (c) evaluation of logistics, (d) evaluation of the appropriateness of the intervention and research procedures to manage and implement the intervention, and (e) preliminary evaluation of participant responses to the intervention.

Secondary objectives:

Safety endpoint:

Complications immediately during and one hour after cardioversion (e.g. arrhythmias, changes in the electrocardiogram, hypotension related to sedation and/or vasodilation or skin irritation).

A composite of major adverse cardiovascular and cerebrovascular events (MACCE) occurring within 24 hours MACCE occurring during 6 weeks follow-up; any hospitalisation and all-cause mortality during 6 weeks follow-up; number (%) of patients in sinus rhythm at 1 hour in the post-shock observation period; idem at the end of 6 weeks follow-up; inventory of all interventions in the study related to cost-of-care. conditions: Emergency Medical Services conditions: Electric Countershock studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: a pilot, non-controlled, non-randomised, single centre study. The Electra-1 pilot study is a prospective intervention feasibility study. primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Duble current electro cardioversion measure: completion of cardioversion to sinus rhythm measure: Incidence of treatment-emergent adverse events (Safety endpoint a) measure: Incidence of treatment-emergent adverse events (Safety endpoint b) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RAV Brabant MWN city: 's-Hertogenbosch state: Noord Brabant zip: 5212VM country: Netherlands lat: 51.69917 lon: 5.30417 hasResults: False

 nctId: NCT06322823 id: 2010.432 briefTitle: Direct Thawing of Vitrified Human Blastocyst overallStatus: COMPLETED date: 2020-01-01 date: 2022-12-31 date: 2023-12-31 date: 2024-03-21 date: 2024-03-21 name: Chinese University of Hong Kong class: OTHER briefSummary: There are more than million frozen embryo transfers around the world each year; a faster, safer, and cheaper method can save a significant amount of money for patients undergoing IVF treatment worldwide. conditions: IVF studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 116 type: ACTUAL name: direct thawing name: Vitrification measure: blastocysts survival rate measure: ferilization rate measure: pregnancy rate measure: live birth rate sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: David Yiu Leung Chan city: Hong Kong zip: 000000 country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06322810 id: ESP vs. PIFB briefTitle: ESP Versus PIFB for Analgesia in Open Cardiac Surgery: a Randomized Control Trial overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2026-04-01 date: 2024-03-21 date: 2024-03-21 name: Taichung Veterans General Hospital class: OTHER briefSummary: This clinical trial compares analgesia efficiency and recovery outcomes between two different fascial plane block techniques (ESPB vs.PIFB) in cardiac surgery patients participant population/health conditions\].

The main questions it aims to answer are:

* Does ESPB provide superior analgesia than PIFB
* Do patients who receive ESPB have better recovery outcomes conditions: Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Erector spinae plane block (ESPB) name: Pecto-intercostal fascial plane blok (PIFB) measure: 48hr opioid consumption measure: Postoperative static pain scores-Day 1 measure: Postoperative static pain scores-Day 2 measure: Postoperative dynamic pain scores-Day 1 measure: Postoperative dynamic pain scores-Day 2 measure: postoperative incentive spirometry volume (ml)-Day 1 measure: postoperative incentive spirometry volume (ml)-Day 2 measure: postoperative incentive spirometry volume (ml)-Day 3 measure: QoL15 (pre-op) measure: QoL15 (POD3) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taichung Veterans General Hospital city: Taichung zip: 407 country: Taiwan name: Yi-Ting Chang, MD role: CONTACT phone: (+886)4-23592525 phoneExt: 4101 email: taco@vghtc.gov.tw name: Yi-Ting Chang, MD role: PRINCIPAL_INVESTIGATOR lat: 24.1469 lon: 120.6839 hasResults: False

 nctId: NCT06322797 id: rTMSinStroke briefTitle: The Safety&Efficacy of Repetitive Transcranial Magnetic Stimulation for Post-Stroke Upper Extremity Function Improvement overallStatus: RECRUITING date: 2022-07-19 date: 2024-12-31 date: 2024-12-31 date: 2024-03-21 date: 2024-03-21 name: MinYoung Kim, MD, PhD class: OTHER briefSummary: A randomized, controlled, subject and rater-blind, exploratory clinical trial to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation for improvement of upper extremity function after stroke. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 15 type: ESTIMATED name: rTMS name: rTMS name: Sham measure: Change of Fugl-Meyer Assessment measure: Change of Range of motion measure: Change of Berg Balance Scale measure: Change of Motor Assessment Scale measure: Change of Trunk Imbalance Scale measure: Change of Functional Ambulation Category measure: Change of Time up and go measure: Change of Manual muscle Test measure: Change of Action reach arm test measure: Change of Jebsen taylor hand function test measure: Change of Functional Independence Measure measure: Change of Modified Barthel index measure: Change of National Institutes of Health Stroke Scale measure: Change of Korean Mini Mental State Exam measure: Change of Clinical Dementia Rating measure: Change of Global Deterioration Scale measure: Change of Geriatric Depression Scale measure: Change of Brain imaging measure: Change of Electroencephalography measure: Change of Evoked Potential measure: Changes in test results of WBC(/uL), RBC(/uL), , Hct(%), PLT(/uL), Hgb(g/dL) measure: Changes in test results of CRP (mg/dL), glucose (mg/dL), BUN (mg/dL), creatinine (mg/dL), total cholesterol (mg/dL) measure: Changes in test results of AST(IU/L), ALT(IU/L) measure: Change of Motricity index sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Rehabilitation Medicine, CHA Bundang Medical Center status: RECRUITING city: Seongnam zip: 13496 country: Korea, Republic of name: MinYoung Kim, MD,PhD role: CONTACT phone: 82-31-780-2954 phoneExt: 2954 email: parkmijin@chamc.co.kr lat: 37.43861 lon: 127.13778 hasResults: False

 nctId: NCT06322784 id: LiJingjing briefTitle: DF(Oat Bran) Intervention on Inflammation, Intestinal Flora, Disease Activity and Quality of Life in Patients With RA overallStatus: COMPLETED date: 2022-11-01 date: 2022-12-01 date: 2024-02-10 date: 2024-03-21 date: 2024-03-21 name: Shenzhen People's Hospital class: OTHER briefSummary: The goal of this clinical trial is to test in Rheumatoid arthritis. The main question it aims to answer are:

* To verify the effect of dietary fiber supplementation on reducing the level of inflammation;
* To verify the effect of dietary fiber supplementation on improving disease activity and quality of life in patients with rheumatoid arthritis .To verify the effect of dietary fiber supplementation on regulating the production of anti-inflammatory short-chain fatty acid in the gut of patients with rheumatoid arthritis.

The experimental group was supplemented with dietary fiber for 12 weeks, and the control group was fed with the Mediterranean diet. Before and after the intervention, 1 tube of 3ml blood and 1 soybean-sized stool were taken and a questionnaire was made conditions: Rheumatoid Arthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Experimental group=1,Control Group=2, primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Researchers set blinding to reduce implementation bias whoMasked: INVESTIGATOR count: 25 type: ACTUAL name: Oat bran (dietary fiber) measure: Disease activity score measure: Quality of life score measure: Compliance of oat bran measure: Inflammatory indicators :TNF- α measure: Inflammatory indicators:IL-6 measure: Inflammatory indicators :IL-10 measure: Inflammatory indicators: ESR measure: Inflammatory indicators :CRP measure: gut flora measure: Adjustment of anti rheumatic drugs sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jingjing Li city: Shenzhen state: Guangdong zip: 518000 country: China lat: 22.54554 lon: 114.0683 hasResults: False

 nctId: NCT06322771 id: APHP240376 briefTitle: Women's Refusal to Participate in a Randomized Trial Involving First-trimester Screening for Pre-eclampsia: Factors Associated With Refusal and Reasons for Acceptance and Refusal acronym: RANSPRE-refus overallStatus: RECRUITING date: 2024-04-11 date: 2025-03 date: 2025-03 date: 2024-03-21 date: 2024-04-15 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: The main objective is to assess whether there are factors associated with women's refusal to participate in a randomized clinical trial involving first-trimester screening for pre-eclampsia. The secondary objective is to qualitatively evaluate the reasons for acceptance and refusal to participate. conditions: Pregnancy Related studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 830 type: ESTIMATED name: Questionnaire name: Questionnaire measure: Factors associated with women's refusal measure: Number of acceptations measure: Number of refusals measure: Demographic characteristics measure: Questionnaire "acceptance" measure: Questionnaire "refusal" sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Port-Royal Maternity status: RECRUITING city: Paris state: IDF zip: 75014 country: France name: Yoann Athiel, MD role: CONTACT lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06322758 id: APHP230851 briefTitle: Driving Pressure-guided Tidal Volume Ventilation in the Acute Respiratory Distress Syndrome acronym: DRIVENT overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-10-01 date: 2026-12-01 date: 2024-03-21 date: 2024-03-26 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Acute respiratory distress syndrome (ARDS) is associated with high mortality, some of which can be attributed to ventilator-induced lung injury (VILI) when artificial ventilation is not customized to the severity of lung injury. As ARDS is characterized by a decrease in aerated lung volume, reducing tidal volume (VT) from 12 to 6 mL/kg of predicted body weight (PBW) was shown to improve survival more than 20 years ago. Since then, the VT has been normalized to the PBW, meaning to the theoretical lung size (before the disease), rather than tailored to the severity of lung injury, i.e., to the size of aerated lung volume. During ARDS, the aerated lung volume is correlated to the respiratory system compliance (Crs). The driving pressure (ΔP), defined as the difference between the plateau pressure and the positive end expiratory pressure, represents the ratio between the VT and the Crs. Therefore, the ΔP normalizes the VT to a surrogate of the aerated lung available for ventilation of the diseased lung, rather than to the theoretical lung size of the healthy lung, and thus represents more accurately the actual strain applied to the lungs. In a post hoc analysis of 9 randomized controlled trials, Amato et al. found that higher ΔP was a better predictor of mortality than higher VT, with an increased risk of death when the ΔP \> 14 cm H2O. These findings have been confirmed in subsequent meta-analysis and large-scale observational data. In a prospective study including 50 patients, the investigators showed that a ΔPguided ventilation strategy targeting a ΔP between 12 and 14 cm H2O significantly reduced the mechanical power, a surrogate for the risk of VILI, compared to a conventional PBW-guided ventilation. In the present study, the investigators hypothesize that the physiological individualization of ventilation (ΔP-guided VT) may improve the outcome of patients with ARDS compared to traditional anthropometrical adjustment (PBW-guided VT) conditions: Acute Respiratory Distress Syndrome ARDS studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: comparing ΔP-guided VT to traditional PBW-guided VT during mechanical ventilation of patients with ARDS. primaryPurpose: TREATMENT masking: NONE count: 750 type: ESTIMATED name: Tidal volume customization in the acute respiratory distress syndrome measure: Mortality measure: Number of days free from mechanical ventilation measure: Ventilator parameters measure: Arterial blood gases measure: Mortality measure: Number of days alive without ventilation measure: Sequential Organ Failure Assessment score (SOFA) measure: Number of days alive without catecholamine measure: Number of days alive without continuous sedation measure: Number of days alive without neuromuscular blockers measure: Number of prone position sessions measure: Use of rescue procedures: inhaled nitric oxide, almitrine, ECMO, ECCO2R measure: Occurrence of ventilator-associated pneumothorax measure: Time to pressure support ventilation; measure: Duration of weaning unreadiness measure: Duration of weaning measure: The rate of tracheostomy measure: Total duration of mechanical ventilation measure: Length of stay sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06322745 id: 1986 briefTitle: Thulium Beam Coagulation Versus Suture Renorrhaphy for Hemostasis of Tumor Bed in Laparoscopic Partial Nephrectomy overallStatus: RECRUITING date: 2023-06-01 date: 2025-01-01 date: 2025-03-01 date: 2024-03-21 date: 2024-03-21 name: Al-Azhar University class: OTHER briefSummary: To compare the outcome of thulium beam coagulation versus suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy. conditions: Renal Tumor conditions: Renal Malignant Tumor studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized prospective comparative study. Two-arm parallel assignment:

First Arm: involves cases of laparoscopic partial nephrectomy done with suture renorrhaphy only for hemostasis of the tumor bed.

Second Arm: involves cases of laparoscopic partial nephrectomy using thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed. primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Suture renorrhaphy only for hemostasis of the tumor bed in laparoscopic partial nephrectomy name: Thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy measure: Intraoperative Warm Ischemia time (WIT) in minutes (time of renal artery clamping). measure: Suture time and operative time in minutes measure: Intraoperative number of sutures for renorraphy measure: Intraoperative Blood loss measure: Blood transfusion rate measure: Renal function: serum creatinine measure: Renal function: estimated GFR (eGFR) measure: Transforming growth factor beta (TGF-β) urine level measure: Monocyte chemoattractant protein (MCP-1) urine level measure: Hospital stay measure: Post operative pain sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Urology Department, Al-Azhar University Hospitals status: RECRUITING city: Cairo zip: 11511 country: Egypt name: Malakah Mohammed, Secretary role: CONTACT phone: +20225107222 email: urologydepartment@azhar.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06322732 id: APHP191125 briefTitle: Optimization of Routine Obstetric and Neonatal Care in the Management of Severe Perinatal Asphyxia in Term or Near-term Newborns: Analysis of Sub-optimal Care acronym: OptiNeoCare overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-09 date: 2025-09 date: 2024-03-21 date: 2024-04-15 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: The purpose of this study is to identify and analyze suboptimal perinatal (obstetric-pediatric) care in the occurrence and management of severe perinatal asphyxia or death of the newborn at or near term.

Perinatal asphyxia is a serious and often unexpected pathology, requiring urgent multidisciplinary care (obstetric - pediatric - intensive care, etc.) with a high level of technical expertise and care coordination. Because of its rarity and complexity, it may be subject to suboptimal care.

The aim of this study is to provide feedback within the center itself, coupled in 1/3 of cases with a confidential investigation into the search for and understanding of suboptimal care.

Primary endpoint:

Frequency of optimal or non-optimal maternal and neonatal management of hypoxic-ischemic encephalopathy (AIE) or neonatal death related to severe perinatal asphyxia. conditions: Perinatal Asphyxia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 336 type: ESTIMATED measure: sub-optimal perinatal care measure: Frequency of suboptimal care measure: Relationship measure: Outcome measure: Characteristics of suboptimal care measure: Determinantes of suboptimal care measure: Ad-hoc survey sex: ALL maximumAge: 1 Month stdAges: CHILD hasResults: False

 nctId: NCT06322719 id: INVIBLADE briefTitle: Hyperangulated vs Macintosh Blades for Intubation With Videolaryngoscopy in ICU acronym: INVIBLADE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-05-01 date: 2024-05-30 date: 2024-03-21 date: 2024-03-21 name: Hospital Clinico Universitario de Santiago class: OTHER briefSummary: Tracheal intubation in the intensive care unit (ICU) is associated with high incidence of difficult intubation and complications. Videolaryngoscopes (VLs) devices have been proposed to improve airway management, and the use of VLs are recommended as first-line or after a first-attempt failure using direct laryngoscopy in ICU airway management algorithms. Although until relatively few years ago there were doubts about whether videolaryngoscopes had advantages over direct laryngoscopy for endotracheal intubation (ETI) in critically ill patients, two recent studies (DEVICE (1), INTUBATE (2)), and a Cochrane review (3) have confirmed that videolaryn should be used?, and what is the best blade? . There are two types of blades commonly used with videolaryngoscopes: the "Macintosh" blade with a slight curvature, and hyperangulated blades. The "Macintosh" blades have a lower angle of vision, but they have the advantage of being similar to the blades commonly used in direct laryngoscopy, making them easy to use for the person performing the ETI. Hyperangulated blades have a greater angle of vision, improving glottic visualization, especially in patients with an anterior glottis. However, the need to overcome this angulation could potentially hinder the passage of the endotracheal tube to the vocal cords. It is unknown if either blade has any advantage for intubating critically ill patients. conditions: Acute Respiratory Failure conditions: Intubation conditions: Intubation; Difficult or Failed conditions: Videolaryngoscopy conditions: Intubation Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 1036 type: ESTIMATED name: Hyperangulated blade videolaryngoscope name: Macintosh blade videolaryngoscope measure: Difference in the first attempt intubation success rate (percentage) measure: Difference in the overall success rate measure: Number of intubation attempts measure: Modified Cormack-Lehane grade of glottic view measure: Diference in the incidence of "easy intubation" measure: Duration of tracheal intubation measure: Reason for unsuccessful intubation on the first attempt measure: Number of videolaryngoscopy attempts measure: Number of attempts to cannulate the trachea with a bougie or an endotracheal tube measure: Operator-assessed difficulty of intubation measure: Need for additional airway equipment measure: Need to change the device for intubation measure: Complications of tracheal intubation sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Clinical Hospital of Santiago de Compostela city: Santiago de Compostela state: A Coruña zip: 15866 country: Spain lat: 42.88052 lon: -8.54569 facility: Complexo Hospitalario Universitario de A Coruña city: A Coruña country: Spain name: Pablo Rama role: CONTACT email: Pablo.rama.maceiras@sergas.es lat: 43.37135 lon: -8.396 facility: Hospital General de Albacete city: Albacete country: Spain name: Luisa María Charco role: CONTACT lat: 38.99424 lon: -1.85643 facility: Hospital de la Santa Creu i Sant Pau, Barcelona city: Barcelona country: Spain name: Marta Giné role: CONTACT lat: 41.38879 lon: 2.15899 facility: Hospital Universitario de Cáceres city: Cáceres country: Spain name: Jose Ignacio Hermoso role: CONTACT email: nachomartinez@gmail.com lat: 39.47649 lon: -6.37224 facility: Hospital de Denia city: Denia country: Spain name: Marta Carrió role: CONTACT lat: 38.84078 lon: 0.10574 facility: Hospital General Universitario de Eche city: Elche country: Spain name: Ana Pérez role: CONTACT lat: 38.26218 lon: -0.70107 facility: Hospital Universitario de Cabueñes, Gijón city: Gijón country: Spain name: Rosaura María Santamarina role: CONTACT lat: 43.53573 lon: -5.66152 facility: Hospital Virgen de las Nieves, Granada city: Granada country: Spain name: Jose Luis Aguilera role: CONTACT lat: 37.18817 lon: -3.60667 facility: Hospital Universitario de Gran Canaria Doctor Negrín city: Las Palmas De Gran Canaria country: Spain name: Angel Becerra role: CONTACT lat: 28.09973 lon: -15.41343 facility: Complejo Asistencial Universitario de León city: León country: Spain name: Inmaculada Fernández role: CONTACT lat: 42.60003 lon: -5.57032 facility: Hospital Universitario Lucus Augusti, Lugo city: Lugo country: Spain name: María Bermúdez role: CONTACT lat: 43.00992 lon: -7.55602 facility: Hospital Gregorio Marañón, Madrid city: Madrid country: Spain name: Mercedes Power role: CONTACT lat: 40.4165 lon: -3.70256 facility: Hospital Universitario 12 de Octubre, Madrid city: Madrid country: Spain name: Raquel García role: CONTACT lat: 40.4165 lon: -3.70256 facility: Hospital Universitario La Paz, Madrid city: Madrid country: Spain name: Irene Vallejo role: CONTACT lat: 40.4165 lon: -3.70256 facility: Hospital Universitario La Princesa city: Madrid country: Spain name: Fernando Ramasco role: CONTACT lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Puerta de Hierro, Majadahonda city: Majadahonda country: Spain name: Sara Del Valle role: CONTACT lat: 40.47353 lon: -3.87182 facility: Hospital Universitario de Móstoles city: Móstoles country: Spain name: Raquel Fernández role: CONTACT lat: 40.32234 lon: -3.86496 facility: Complexo Hospitalario Universitario de Ourense city: Ourense country: Spain name: María Concepción Alonso role: CONTACT lat: 42.33669 lon: -7.86407 facility: Hospital Universitario Central de Asturias (HUCA), Oviedo city: Oviedo country: Spain name: María Cristina Iglesias role: CONTACT lat: 43.36029 lon: -5.84476 facility: Clínica Universidad de Navarra, Pamplona city: Pamplona country: Spain name: Marc Vives role: CONTACT lat: 42.81687 lon: -1.64323 facility: Complexo Hospitalario Universitario de Pontevedra city: Pontevedra country: Spain name: Marina Varela role: CONTACT lat: 42.431 lon: -8.64435 facility: Hospital Universitario Donostia, San Sebastián city: San Sebastián country: Spain name: Anxo Rubín role: CONTACT lat: 43.31283 lon: -1.97499 facility: Hospital Universitario Marqués de Valdecilla, Santander city: Santander country: Spain name: Mónica Williams role: CONTACT lat: 43.46472 lon: -3.80444 facility: Complejo Asistencial de Segovia city: Segovia country: Spain name: Francisco Javier García role: CONTACT lat: 40.94808 lon: -4.11839 facility: Hospital Clínico Universitario de Valencia city: Valencia country: Spain name: Sara Martínez role: CONTACT lat: 39.46975 lon: -0.37739 facility: Hospital Universitario La Fe de Valencia city: Valencia country: Spain name: Azucena Pajares role: CONTACT lat: 39.46975 lon: -0.37739 facility: Complexo Hospitalario Universitario Álvaro Cunqueiro de Vigo city: Vigo country: Spain name: Inés María Rodríguez Naz role: CONTACT email: inesnaz@gmail.com lat: 42.23282 lon: -8.72264 facility: Hospital Ribera Povisa Vigo city: Vigo country: Spain name: Rafael Cabadas role: CONTACT lat: 42.23282 lon: -8.72264 hasResults: False

 nctId: NCT06322706 id: ABSK021-105 briefTitle: A Clinical Trial to Evaluate a High-Fat Meal and Omeprazole Enteric-coated Tablets on ASBK021 overallStatus: NOT_YET_RECRUITING date: 2024-03-28 date: 2024-12-31 date: 2025-12-31 date: 2024-03-21 date: 2024-03-21 name: Abbisko Therapeutics Co, Ltd class: INDUSTRY briefSummary: Part A: a single-center, randomized, open-label, three-cycle study to evaluate the pharmacokinetic (PK) profile of different doses of ABSK021 Capsules and the effect of a high-fat meal on the pharmacokinetic profile of ABSK021 Capsules in healthy subjects Part B: a single-center, open-label, fixed-sequence study to evaluate the effect of multiple oral doses of Omeprazole Enteric-coated Tablets on the PK profile of ABSK021 Capsules in healthy subjects conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: ABSK021 name: Omeprazole measure: Cmax measure: tmax measure: AUC0-∞ measure: AUClast measure: AE measure: SAE measure: blood pressure measure: respiratory rate measure: ECG QT Interval measure: t1/2 measure: CL/F measure: Vz/F sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06322693 id: 213348 id: 2023-507564-39 type: EUDRACT_NUMBER briefTitle: A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) overallStatus: RECRUITING date: 2016-07-08 date: 2025-08-29 date: 2027-02-19 date: 2024-03-21 date: 2024-03-21 name: GlaxoSmithKline class: INDUSTRY briefSummary: This is a first-in-human study evaluating the anti-T cell immunoglobulin and mucin containing protein-3 (TIM-3) antibody TSR-022. The study will be conducted in 2 parts with Part 1 consisting of dose escalation and Part 2 dose expansion. Part 1 will determine the recommended Phase 2 dose (RP2D) of TSR-022 and Part 2 will evaluate the antitumor activity of TSR-022 in combination with TSR-042 or docetaxel and as monotherapy. conditions: Neoplasms studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: This is a multi-center, open-label, first-in-human Phase 1 study. primaryPurpose: TREATMENT masking: NONE count: 475 type: ESTIMATED name: TSR-022 name: Nivolumab name: TSR-042 name: TSR-033 name: Docetaxel name: Pemetrexed name: Cisplatin name: Carboplatin measure: Part 1 (a): Number of participants achieving dose limiting toxicity (DLTs) measure: Part 1 (b,c,d): Number of participants achieving dose limiting toxicity (DLTs) measure: Part 1 (f,g,h): Number of participants achieving dose limiting toxicity (DLTs) measure: Part 1: Number of participants with adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, treatment emergent adverse events (TEAEs), TEAEs leading to death and immune-related adverse events (irAEs) measure: Part 1: Number of participants with clinically significant changes in laboratory parameters, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) status, physical examination and use of concomitant medications measure: Part 1 (e) and Part 2: Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 measure: Part 1 (a, b, c, d, f, g, h): ORR by RECIST v 1.1 measure: Part 2 (A, B, C, D) : ORR by Immune related RECIST (irRECIST) measure: Part 2: Duration of response (DOR) by RECIST v 1.1 measure: Part 2 (A, B, C, D) : DOR by irRECIST measure: Parts 1 and 2: Disease control rate (DCR) by RECIST v 1.1 measure: Part 2 (A, B, C, D) : DCR by irRECIST measure: Part 2: Progression-free survival (PFS) by RECIST v 1.1 measure: Part 2 (A, B, C, D) : PFS by irRECIST measure: Parts 1 and 2 (A, B, C, D, E, F) : Serum concentration of TSR-022 measure: Part 1d: Serum concentration of TSR-033 measure: Part 1 (c, d, e, f, g ,h): Serum concentration of TSR-042 measure: Part 2 (A, B, C, D, F): Serum concentration of TSR-042 measure: Part 2: Overall survival (OS) measure: Part 1a: Minimum plasma concentration (Cmin) of TSR-022 as monotherapy measure: Part 1b: Cmin of TSR-022 in combination with nivolumab measure: Part 1c: Cmin of TSR-022 in combination with TSR-042 measure: Part 1d: Cmin of TSR-022 in combination with TSR-042 and TSR-033 measure: Part 1a: Area under the concentration × time curve from time 0 to infinity AUC (0-inf) of TSR-022 as monotherapy measure: Part 1b: AUC (0-inf) of TSR-022 in combination with nivolumab measure: Part 1c: AUC (0-inf) of TSR-022 in combination with TSR-042 measure: Part 1d: AUC (0-inf) of TSR-022 in combination with TSR-042 and TSR-033 measure: Part 1a: Area under the concentration time curve from time 0 to last assessment (AUC 0-last) of TSR-022 as monotherapy measure: Part 1b: AUC (0-last) of TSR-022 in combination with nivolumab measure: Part 1c: AUC (0-last) of TSR-022 in combination with TSR-042 measure: Part 1d: AUC (0-last) of TSR-022 in combination with TSR-042 and TSR-033 measure: Part 1a: Terminal half life (t 1/2) of TSR-022 as monotherapy measure: Part 1b: t1/2 of TSR-022 and in combination with nivolumab measure: Part 1c: t1/2 of TSR-022 in combination with TSR-042 measure: Part 1d: t1/2 of TSR-022 in combination with TSR-042 and TSR-033 measure: Part 1a: Area under the concentration × time curve during the dosing interval (AUCtau) of TSR-022 as monotherapy measure: Part 1b: AUCtau of TSR-022 and in combination with nivolumab measure: Part 1c: AUCtau of TSR-022 in combination with TSR-042 measure: Part 1d: AUCtau of TSR-022 in combination with TSR-042 and TSR-033 measure: Part 1: Number of participants with anti-drug antibodies (ADAs) to TSR-022 measure: Part 2 (A, B, C, D, E, F): Number of participants with ADA to anti-TSR-022 measure: Part 1 (c, d, e, f, g ,h): Number of participants with ADA to TSR-042 measure: Part 2 (A, B, C, D, F): Number of Participants with ADA to TSR-042 measure: Part 1d: Number of participants with ADA to TSR-033 measure: Part 2F: Number of participants with AEs, SAEs, AEs leading to discontinuation, TEAEs, TEAEs leading to death measure: Part 2F: Percent change from Baseline in Alpha-fetoprotein (AFP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GSK Investigational Site status: COMPLETED city: Goodyear state: Arizona zip: 85338 country: United States lat: 33.43532 lon: -112.35821 facility: GSK Investigational Site status: COMPLETED city: Scottsdale state: Arizona zip: 85258 country: United States lat: 33.50921 lon: -111.89903 facility: GSK Investigational Site status: COMPLETED city: Tucson state: Arizona zip: 85704 country: United States lat: 32.22174 lon: -110.92648 facility: GSK Investigational Site status: COMPLETED city: Tucson state: Arizona zip: 85711 country: United States lat: 32.22174 lon: -110.92648 facility: GSK Investigational Site status: RECRUITING city: Encinitas state: California zip: 92024 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Edward F McClay role: PRINCIPAL_INVESTIGATOR lat: 33.03699 lon: -117.29198 facility: GSK Investigational Site status: RECRUITING city: Fountain Valley state: California zip: 92708 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Haresh S. Jhangiani role: PRINCIPAL_INVESTIGATOR lat: 33.70918 lon: -117.95367 facility: GSK Investigational Site status: RECRUITING city: Los Angeles state: California zip: 90024 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Antoni Ribas role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: GSK Investigational Site status: RECRUITING city: Los Angeles state: California zip: 90025 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Peter D Boasberg role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: GSK Investigational Site status: RECRUITING city: San Marcos state: California zip: 92069 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Edward F McClay role: PRINCIPAL_INVESTIGATOR lat: 33.14337 lon: -117.16614 facility: GSK Investigational Site status: RECRUITING city: Whittier state: California zip: 90606 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Paul La Porte role: PRINCIPAL_INVESTIGATOR lat: 33.97918 lon: -118.03284 facility: GSK Investigational Site status: RECRUITING city: Aurora state: Colorado zip: 80012 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Allen L. Cohn role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 facility: GSK Investigational Site status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Theresa Medina role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 facility: GSK Investigational Site status: COMPLETED city: Denver state: Colorado zip: 80218 country: United States lat: 39.73915 lon: -104.9847 facility: GSK Investigational Site status: RECRUITING city: Denver state: Colorado zip: 80218 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Gerald Falchook role: PRINCIPAL_INVESTIGATOR lat: 39.73915 lon: -104.9847 facility: GSK Investigational Site status: RECRUITING city: New Haven state: Connecticut zip: 06511 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Patricia M Lorusso role: PRINCIPAL_INVESTIGATOR lat: 41.30815 lon: -72.92816 facility: GSK Investigational Site status: RECRUITING city: Washington state: District of Columbia zip: 20007 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Michael Pishvaian role: PRINCIPAL_INVESTIGATOR lat: 38.89511 lon: -77.03637 facility: GSK Investigational Site status: COMPLETED city: Jacksonville state: Florida zip: 32224 country: United States lat: 30.33218 lon: -81.65565 facility: GSK Investigational Site status: COMPLETED city: Miami Beach state: Florida zip: 33140 country: United States lat: 25.79065 lon: -80.13005 facility: GSK Investigational Site status: RECRUITING city: Sarasota state: Florida zip: 34232 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Judy S Wang role: PRINCIPAL_INVESTIGATOR lat: 27.33643 lon: -82.53065 facility: GSK Investigational Site status: RECRUITING city: Tampa state: Florida zip: 33612 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Zeynep Eroglu role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 facility: GSK Investigational Site status: COMPLETED city: Atlanta state: Georgia zip: 30322 country: United States lat: 33.749 lon: -84.38798 facility: GSK Investigational Site status: COMPLETED city: Augusta state: Georgia zip: 30912 country: United States lat: 33.47097 lon: -81.97484 facility: GSK Investigational Site status: RECRUITING city: Arlington Heights state: Illinois zip: 60005 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Richard S Siegel role: PRINCIPAL_INVESTIGATOR lat: 42.08836 lon: -87.98063 facility: GSK Investigational Site status: RECRUITING city: Chicago state: Illinois zip: 60637 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jason J Luke role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: GSK Investigational Site status: RECRUITING city: Niles state: Illinois zip: 60714 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Richard S Siegel role: PRINCIPAL_INVESTIGATOR lat: 42.01892 lon: -87.80284 facility: GSK Investigational Site status: RECRUITING city: Iowa City state: Iowa zip: 52242-1009 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Mohammed Milhem role: PRINCIPAL_INVESTIGATOR lat: 41.66113 lon: -91.53017 facility: GSK Investigational Site status: COMPLETED city: Wichita state: Kansas zip: 67214 country: United States lat: 37.69224 lon: -97.33754 facility: GSK Investigational Site status: COMPLETED city: Louisville state: Kentucky zip: 40202 country: United States lat: 38.25424 lon: -85.75941 facility: GSK Investigational Site status: RECRUITING city: Pikeville state: Kentucky zip: 41501 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Christopher C. Croot role: PRINCIPAL_INVESTIGATOR lat: 37.47927 lon: -82.51876 facility: GSK Investigational Site status: RECRUITING city: Rockville state: Maryland zip: 20850 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: John M Wallmark role: PRINCIPAL_INVESTIGATOR lat: 39.084 lon: -77.15276 facility: GSK Investigational Site status: RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Keith Flaherty role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: GSK Investigational Site status: COMPLETED city: Detroit state: Michigan zip: 48202 country: United States lat: 42.33143 lon: -83.04575 facility: GSK Investigational Site status: COMPLETED city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 facility: GSK Investigational Site status: COMPLETED city: Hackensack state: New Jersey zip: 07601 country: United States lat: 40.88593 lon: -74.04347 facility: GSK Investigational Site status: RECRUITING city: Bronx state: New York zip: 10461 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Sanjay Goel role: PRINCIPAL_INVESTIGATOR lat: 40.84985 lon: -73.86641 facility: GSK Investigational Site status: RECRUITING city: New York state: New York zip: 10016 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Janice Mehnert role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: GSK Investigational Site status: COMPLETED city: Cincinnati state: Ohio zip: 45242 country: United States lat: 39.12713 lon: -84.51435 facility: GSK Investigational Site status: RECRUITING city: Cleveland state: Ohio zip: 44106 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: David Bajor role: PRINCIPAL_INVESTIGATOR lat: 41.4995 lon: -81.69541 facility: GSK Investigational Site status: RECRUITING city: Toledo state: Ohio zip: 43623 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Rex B Mowat role: PRINCIPAL_INVESTIGATOR lat: 41.66394 lon: -83.55521 facility: GSK Investigational Site status: RECRUITING city: Eugene state: Oregon zip: 97401 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Joseph Fiorillo role: PRINCIPAL_INVESTIGATOR lat: 44.05207 lon: -123.08675 facility: GSK Investigational Site status: COMPLETED city: Portland state: Oregon zip: 97213-2982 country: United States lat: 45.52345 lon: -122.67621 facility: GSK Investigational Site status: COMPLETED city: Bethlehem state: Pennsylvania zip: 18015 country: United States lat: 40.62593 lon: -75.37046 facility: GSK Investigational Site status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15213-2584 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Diwakar Davar role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 facility: GSK Investigational Site status: RECRUITING city: Charleston state: South Carolina zip: 29425 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Theodore G Gourdin role: PRINCIPAL_INVESTIGATOR lat: 32.77657 lon: -79.93092 facility: GSK Investigational Site status: COMPLETED city: Greenville state: South Carolina zip: 29605 country: United States lat: 34.85262 lon: -82.39401 facility: GSK Investigational Site status: RECRUITING city: Nashville state: Tennessee zip: 37203 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jeffrey Roger Infante role: PRINCIPAL_INVESTIGATOR lat: 36.16589 lon: -86.78444 facility: GSK Investigational Site status: COMPLETED city: Austin state: Texas zip: 78705 country: United States lat: 30.26715 lon: -97.74306 facility: GSK Investigational Site status: RECRUITING city: Dallas state: Texas zip: 75246 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Charles L Cowey role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: GSK Investigational Site status: COMPLETED city: Fort Worth state: Texas zip: 76104 country: United States lat: 32.72541 lon: -97.32085 facility: GSK Investigational Site status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Julio Peguero role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 facility: GSK Investigational Site status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Timothy Yap role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 facility: GSK Investigational Site status: RECRUITING city: Longview state: Texas zip: 75601 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Donald Richards role: PRINCIPAL_INVESTIGATOR lat: 32.5007 lon: -94.74049 facility: GSK Investigational Site status: RECRUITING city: McAllen state: Texas zip: 78503-1298 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Habib M. H. Ghaddar role: PRINCIPAL_INVESTIGATOR lat: 26.20341 lon: -98.23001 facility: GSK Investigational Site status: COMPLETED city: San Antonio state: Texas zip: 78229 country: United States lat: 29.42412 lon: -98.49363 facility: GSK Investigational Site status: COMPLETED city: Temple state: Texas zip: 76508 country: United States lat: 31.09823 lon: -97.34278 facility: GSK Investigational Site status: RECRUITING city: Tyler state: Texas zip: 75702 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Donald Richards role: PRINCIPAL_INVESTIGATOR lat: 32.35126 lon: -95.30106 facility: GSK Investigational Site status: RECRUITING city: Weslaco state: Texas zip: 78596 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Habib M. H. Ghaddar role: PRINCIPAL_INVESTIGATOR lat: 26.15952 lon: -97.99084 facility: GSK Investigational Site status: RECRUITING city: Fairfax state: Virginia zip: 8613 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Alexander I. Spira role: PRINCIPAL_INVESTIGATOR lat: 38.84622 lon: -77.30637 facility: GSK Investigational Site status: RECRUITING city: Kennewick state: Washington zip: 99336 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Ying Zhuo role: PRINCIPAL_INVESTIGATOR lat: 46.21125 lon: -119.13723 facility: GSK Investigational Site status: RECRUITING city: Puyallup state: Washington zip: 98373 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Andrea Veatch role: PRINCIPAL_INVESTIGATOR lat: 47.18538 lon: -122.2929 facility: GSK Investigational Site status: RECRUITING city: Tacoma state: Washington zip: 98405 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Andrea Veatch role: PRINCIPAL_INVESTIGATOR lat: 47.25288 lon: -122.44429 facility: GSK Investigational Site status: COMPLETED city: Madison state: Wisconsin zip: 53792 country: United States lat: 43.07305 lon: -89.40123 facility: GSK Investigational Site status: RECRUITING city: Daegu zip: 41931 country: Korea, Republic of name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Sun Hyo Park role: PRINCIPAL_INVESTIGATOR lat: 35.87028 lon: 128.59111 facility: GSK Investigational Site status: RECRUITING city: Seongnam-si, Gyeonggi-do zip: 13620 country: Korea, Republic of name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Yu Jung kim role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site status: RECRUITING city: Seoul zip: 02841 country: Korea, Republic of name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Yoon Ji Choi role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: GSK Investigational Site status: RECRUITING city: Seoul zip: 03722 country: Korea, Republic of name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Hye Ryun Kim role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: GSK Investigational Site status: RECRUITING city: Seoul zip: 06351 country: Korea, Republic of name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Myung-Ju Ahn role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: GSK Investigational Site status: RECRUITING city: Seoul zip: 7061 country: Korea, Republic of name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jin-Soo Kim role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: GSK Investigational Site status: RECRUITING city: Palma de Mallorca state: Islas Baleares zip: 07120 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Aitor Azkárate Martínez role: PRINCIPAL_INVESTIGATOR lat: 39.56939 lon: 2.65024 facility: GSK Investigational Site status: RECRUITING city: Madrid state: Navarra zip: 28027 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Eduardo Castanon Alvarez role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: GSK Investigational Site status: RECRUITING city: Barcelona zip: 08017 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Santiago Viteri Ramírez role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: GSK Investigational Site status: RECRUITING city: Barcelona zip: 08035 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Enriqueta Felip role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: GSK Investigational Site status: RECRUITING city: Barcelona zip: 8028 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Andrés Aguilar Hernández role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: GSK Investigational Site status: RECRUITING city: Girona zip: 17007 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Joaquim Bosch Barrera role: PRINCIPAL_INVESTIGATOR lat: 41.98311 lon: 2.82493 facility: GSK Investigational Site status: RECRUITING city: Jerez de la Frontera zip: 11407 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jesús Corral Jaime role: PRINCIPAL_INVESTIGATOR lat: 36.68645 lon: -6.13606 facility: GSK Investigational Site status: RECRUITING city: L'Hospitalet De Llobregat zip: 08908 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: María Jové Casulleras role: PRINCIPAL_INVESTIGATOR lat: 41.35967 lon: 2.10028 facility: GSK Investigational Site status: RECRUITING city: Las Palmas De Gran Canaria zip: 35016 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Delvys Rodriguez Abreu role: PRINCIPAL_INVESTIGATOR lat: 28.09973 lon: -15.41343 facility: GSK Investigational Site status: RECRUITING city: Madrid zip: 28040 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Victor Moreno Garcia role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: GSK Investigational Site status: RECRUITING city: Madrid zip: 28041 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Luis Paz Ares role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: GSK Investigational Site status: RECRUITING city: Madrid zip: 28046 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Javier De Castro Carpeno role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: GSK Investigational Site status: RECRUITING city: Majadahonda (Madrid) zip: 28222 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Mariano Provencio Pulla role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site status: RECRUITING city: Málaga zip: 29010 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jose Manuel Trigo Pérez role: PRINCIPAL_INVESTIGATOR lat: 36.72016 lon: -4.42034 facility: GSK Investigational Site status: COMPLETED city: Pamplona zip: 31008 country: Spain lat: 42.81687 lon: -1.64323 facility: GSK Investigational Site status: RECRUITING city: Santander zip: 39008 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Marta López-Brea Piqueras role: PRINCIPAL_INVESTIGATOR lat: 43.46472 lon: -3.80444 facility: GSK Investigational Site status: RECRUITING city: Sevilla zip: 41013 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Amparo Sánchez Gastaldo role: PRINCIPAL_INVESTIGATOR lat: 37.38283 lon: -5.97317 facility: GSK Investigational Site status: RECRUITING city: Valencia zip: 46010 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Desamparados Roda Pérez role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 facility: GSK Investigational Site status: RECRUITING city: Valencia zip: 46026 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Oscar Juan Vidal role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06322680 id: ZSPAC-03 briefTitle: Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-06-01 date: 2027-02-01 date: 2024-03-21 date: 2024-03-21 name: Shanghai Zhongshan Hospital class: OTHER name: Huadong Hospital name: RenJi Hospital name: The First People's Hospital of Yunnan name: First Affiliated Hospital Xi'an Jiaotong University name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School briefSummary: Pancreaticoduodenectomy (PD) is the standard treatment for tumors of the pancreatic head, distal bile duct, duodenum, and ampulla of Vater. With advances in surgical experience and instrumentation, the mortality rate of PD has decreased to below 5% in high-volume pancreatic centers. However, the postoperative complication rate remains high at 25%-50%, limiting the development and application of PD.

The main postoperative complications of PD are postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE), post-pancreatectomy hemorrhage (PPH), and biliary leakage (BL). POPF, BL, and the subsequent abdominal infection, PPH, etc. are the main causes of death during hospitalization. Even in large, relatively mature pancreatic centers, the incidence of POPF remains as high as 10%-40%. In recent years, various methods have been used to prevent and treat POPF and BL after PD, such as pancreatic duct stent external drainage and external biliary drainage.

To date, there have been many studies by domestic and foreign scholars on the advantages and disadvantages of biliary and pancreatic duct external drainage versus internal drainage in PD in terms of perioperative POPF incidence, mortality rate, etc., but the research results are not consistent. Overall, pancreatic duct stent external drainage is only recommended for patients with a high risk of pancreatic fistula during PD. Currently, there have been a few relevant studies exploring and verifying the preventive effect of pancreatic duct stent external drainage on pancreatic fistula in patients with high risk of pancreatic fistula. For example, a retrospective study of 98 patients with soft pancreatic parenchyma by Teruyuki Usub et al. found that there was no significant difference between groups with and without pancreatic duct stent in preventing pancreatic fistula. However, due to the low level of evidence, only a few risk factors such as pancreatic texture and pancreatic duct diameter were included, and the risk of POPF was not systematically evaluated. Further clinical exploration and verification are needed. In 2013, Mark P Callery et al. proposed a pancreatic fistula risk score (The fistula risk score, FRS) based on the pancreatic fistula standard defined by the International Pancreatic Fistula Study Group, which included pancreatic texture, pathological type, pancreatic duct diameter, and intraoperative blood loss. This model can be used to systematically and quantitatively evaluate the risk of POPF. Previous studies did not have a clear stratification for patients undergoing pancreatic duct stent external drainage, which may have included too many patients with a low risk of pancreatic fistula, resulting in inaccurate results. Therefore, it is necessary to re-evaluate the effectiveness of pancreatic duct stent external drainage in preventing clinically relevant pancreatic fistula based on stratification of pancreatic fistula risk and disease type. At the same time, pancreatic juice contains a variety of digestive enzymes, of which pancreatic lipase, trypsin, and chymotrypsin all need to be activated by bile to play a role in digesting and decomposing fat and protein. Theoretically, biliary and pancreatic juice diversion may be able to reduce the incidence of pancreatic fistula and its related complications in PD patients.

Thus, the investigators design the present study to evaluate the impact of main pancreatic duct and biliary duct external drainage on postoperative complication, especially POPF. conditions: Pancreaticoduodenectomy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, Multicenter, Controlled, Superiority Trial primaryPurpose: TREATMENT masking: NONE count: 322 type: ESTIMATED name: Main pancreatic duct and biliary duct external drainage name: Main pancreatic duct and biliary duct internal drainage measure: The incidence of clinically relevant postoperative pancreatic fistula (B/C grade fistula) within 90 days after surgery measure: Surgical Complications: Incidence and grading of complications within 90 days after surgery measure: Surgical Complications: Clavien-Dindo classification measure: Surgical Complications: Mortality rate measure: Surgical Complications: reoperation rate measure: Surgical Complications: readmission rate measure: Surgical Complications: rate of digital subtraction angiography for postoperative pancreatic hemorrhage measure: Surgical Complications: Total cost of perioperative treatment measure: Surgical Complications: Length of hospital stay measure: Adjuvant treatment: Proportion of patients with delayed adjuvant treatment (≥12 weeks) due to complications such as pancreatic fistula after surgery measure: Adjuvant treatment: Interval between the start of adjuvant treatment and surgery measure: Long-term survival related to malignant tumors: Overall survival (OS) measure: Long-term survival related to malignant tumors: Disease-free survival (DFS) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Hospital city: Shanghai state: Shanghai zip: 200000 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06322667 id: BAN2401-J081-401 briefTitle: A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab overallStatus: RECRUITING date: 2023-12-22 date: 2027-12-31 date: 2027-12-31 date: 2024-03-21 date: 2024-03-21 name: Eisai Co., Ltd. class: INDUSTRY briefSummary: The primary purpose of this study is to investigate the characteristics of amyloid related imaging abnormalities (ARIA) and investigate the treatment continuation status (e.g., continuation, interruption) after the onset of ARIA in routine clinical practice in participants treated with lecanemab. conditions: Alzheimer's Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 5000 type: ESTIMATED name: No Intervention measure: Number of Participants With Amyloid Related Imaging Abnormality-Oedema/Effusion (ARIA-E) and Amyloid Related Imaging Abnormality-Microhemorrhage and Hemosiderin Deposit, and Cerebellar Microhaemorrhage (ARIA-H) measure: Number of Participants With Interruption or Discontinuation of Lecanemab After Onset of ARIA measure: Number of Participants With Infusion Related Reaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eisai trial site 2 status: RECRUITING city: Hiroshima country: Japan lat: 34.4 lon: 132.45 facility: Eisai trial site 3 status: RECRUITING city: Kyoto country: Japan lat: 35.02107 lon: 135.75385 facility: Eisai trial site 1 status: RECRUITING city: Tokyo country: Japan lat: 35.6895 lon: 139.69171 hasResults: False

 nctId: NCT06322654 id: 2023/ABM/01/00004/P/02 briefTitle: A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA (Spinal Muscular Atrophy) Patients acronym: SMArt overallStatus: RECRUITING date: 2023-12-21 date: 2027-03-31 date: 2027-07 date: 2024-03-21 date: 2024-03-21 name: Wiktor Dega University Orthopedic and Rehabilitation Hospital class: OTHER briefSummary: A head-to-head study comparing the functional value of two models of robotically assisted rehabilitation in patients with SMA. A single-center, randomized, single-blinded, comparative study of Robotically Assisted Verticalization versus Robotically Assisted Locomotion.

The objective of research:

The main goal of the project is to determine the optimal robotically assisted rehabilitation model for people with SMA depending on age and baseline functional status. The study consists of a head-to-head comparison of two rehabilitation models.

1. Research period: 4 years
2. Patients age: 0-21 y.o.
3. Group size: 200 patients (100 patients in each group)
4. Assignment of patients to study groups in a randomised manner conditions: SMA studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are two research groups with 100 patients in each group.

1. Experimental: Robotically Assisted Locomotion
2. Comparison: Robotically Assisted Verticalization primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Patients and their parents will not be blinded by the nature of the therapeutic procedure used after random allocation to the treatment group. Study personnel will be divided into Blinded Team and Unblinded Team to ensure objectivity of the assessment of safety and effectiveness of both strategies. whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Robotically Assisted Locomotion name: Robotically Assisted Verticalization measure: Clinical assessment of patients using Children's Hospital Of Philadelphia Infant Test Of Neuromuscular Disorders, Revised Upper Limb Module, Hammersmith Functional Motor Scale measure: Clinical assessment of patients using Balance test minimum 1 min., Self-walk test of at least 2 meters, 6-minute gait test, Up&Go test, 10 meters gait test, hip range of motion and muscle strength evaluation. measure: Functional assessment of patients using GMFM (Gross Motor Function Measure) scale measure: X-ray or ultrasound scan imaging assessment of the spine, hip joints and bone mineral density measure: Assessment of the quality of life of patients and their caregivers using Pediatric Quality of Life Inventory ver. 4.0 measure: Hospitalization during or between rehabilitations that take place each 6 months measure: Occurence of discomfort during therapy requiring abrupt interruption or significant modification measure: Number of fractures sex: ALL maximumAge: 21 Years stdAges: CHILD stdAges: ADULT facility: Wiktor Dega University Orthopedic and Rehabilitation Hospital status: RECRUITING city: Poznań zip: 61-545 country: Poland name: Marek Jóźwiak role: CONTACT phone: 696052475 phoneExt: +48 email: sma@orsk.pl name: Radosław Rutkowski role: CONTACT phone: 696052475 email: sma@orsk.pl lat: 52.40692 lon: 16.92993 hasResults: False

 nctId: NCT06322641 id: DAS-8092 id: U1111-1303-3089 type: OTHER domain: World Health Organization (WHO) briefTitle: A Study to Understand the Real-world Awareness and Perceptions of Systemic inFLAMmation and rolE of hsCRP as a Biomarker in Patients With AtheroSclerotic CardioVascular Disease and Chronic Kidney Disease Among Nephrologists overallStatus: ENROLLING_BY_INVITATION date: 2024-03-26 date: 2024-04-26 date: 2024-04-26 date: 2024-03-21 date: 2024-04-03 name: Novo Nordisk A/S class: INDUSTRY briefSummary: The purpose of this survey is to collect information for scientific research and to better understand the role of systemic inflammation in identification, treatment and management of patients with Atherosclerotic Cardiovascular Disease (ASCVD) and Chronic Kidney Disease (CKD) conditions: Atherosclerotic Cardiovascular Disease (ASCVD) conditions: Chronic Kidney Disease (CKD) conditions: Systemic Inflammation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 336 type: ESTIMATED name: No treatment given measure: Nephrologists' perceptions towards the role of systemic inflammation in the identification, treatment and management of patients with ASCVD and CKD sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: KJT Group, Inc. city: Rochester state: New York zip: 14623 country: United States lat: 43.15478 lon: -77.61556 hasResults: False

 nctId: NCT06322628 id: VSA006-2001 briefTitle: A Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of VSA006 in Chinese NASH Patients overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2026-07 date: 2024-03-21 date: 2024-03-21 name: Visirna Therapeutics HK Limited class: INDUSTRY briefSummary: Human genetic studies have shown that loss of function (LOF) mutations in HSD17β13 gene have a protective effect on the progression of alcohol-related and non-alcohol-related liver diseases, such as NASH, without significant adverse phenotypes.

VSA006 is a siRNA drug targeting HSD17β13 mRNA in the liver and reduce the protein level of HSD17β13. Based on phase 1 study results in healthy volunteers and NASH/suspected NASH patients, this phase 2 study is designed to evaluate the efficacy, safety, PK profiles and immunogenicity of VSA006 in Chinese NASH patients. conditions: Nash studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: VSA006 name: Placebo measure: Percentage of Participants Achieving ≥ 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH measure: Percentage of Participants Achieving NASH Improvement with no Worsening of Fibrosis measure: Compared with placebo, the percentage change in serum alanine aminotransferase (ALT) measure: Compared with placebo, the change in liver fat fraction from baseline and liver fat percentage change from baseline measure: Compared with placebo, the percentage of participants with a > 30% decrease in liver fat fraction from baseline measure: Compared with placebo, the change and percentage change in noninvasive markers of fibrosis from baseline: FIB-4, NAFLD fibrosis score, and AST/PLT ratio index (APRI) measure: Percentage of Participants Achieving NASH Resolution with no Worsening of Fibrosis measure: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and their correlation with VSA006 measure: Maximum observed concentration (Cmax) of VSA006 measure: Time of maximum concentration of VSA006 (Tmax) measure: Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of VSA006 measure: anti-drug antibodies (ADAs) of VSA006 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06322615 id: MC221001 id: NCI-2024-00538 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-004067 type: OTHER domain: Mayo Clinic Institutional Review Board id: MC221001 type: OTHER domain: Mayo Clinic in Rochester briefTitle: Acupressure for Reducing Anxiety in Patients Undergoing Chemotherapy overallStatus: RECRUITING date: 2023-08-08 date: 2025-12-31 date: 2025-12-31 date: 2024-03-21 date: 2024-04-23 name: Mayo Clinic class: OTHER briefSummary: This clinical trial evaluates whether acupressure is helpful to reduce anxiety related to chemotherapy. Anxiety is experienced by many patients with cancer. Anxiety can be related to chemotherapy and may contribute to other symptoms, such as nausea and poor quality of life. Some patients diagnosed with cancer express interest in non-medicinal ways to manage symptoms. Acupressure is a noninvasive intervention that can be used for many different symptoms. Acupressure is well tolerated with minimal reports of adverse reactions, making it a good choice for patients with cancer. This study may help researchers learn whether acupressure is useful for managing anxiety in patients undergoing chemotherapy. conditions: Hematopoietic and Lymphatic System Neoplasm conditions: Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: Acupressure Therapy name: Educational Intervention name: Electronic Health Record Review name: Questionnaire Administration measure: Number of patients approached about undergoing acupressure intervention (Feasibility) measure: Number of patients interested in the initial acupressure intervention in the chemotherapy unit (Feasibility) measure: Number of patients interested in the home acupressure intervention (Feasibility) measure: Time taken for each nurse-led acupressure intervention in the chemotherapy unit (Feasibility) measure: Patient-reported changes in acute anxiety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Laura S. Rhee, D.O. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06322602 id: 23-009112 id: NCI-2024-01762 type: REGISTRY domain: CTRP (Clinical Trials Reporting Program) briefTitle: Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection in Patients With Brain Tumors overallStatus: RECRUITING date: 2024-02-28 date: 2029-03 date: 2029-03 date: 2024-03-21 date: 2024-03-26 name: Mayo Clinic class: OTHER briefSummary: This observational trial evaluates the use of Ommaya reservoir placed during a biopsy to collect biomarkers longitudinally in patients with brain tumor. A biomarker is a measurable indicator of the severity or presence of the disease state. An Ommaya reservoir is a small device that's implanted under the scalp. It allows the doctor to take samples of cerebrospinal fluid (CSF) in the future without doing a spinal tap. The identification of biomarkers in CSF is rapidly emerging as a promising minimally invasive approach for monitoring tumor growth and response to therapy. In the future, these biomarkers may be used to help determine what treatments could be most effective and how well a tumor has responded to prior therapy. Currently, limited long-term access to CSF has made it difficult for studies to learn if collecting CSF at different points in the treatment process is useful. Having an Ommaya reservoir placed during a biopsy may allow for longitudinal biomarker collection in patients with brain tumor. conditions: Brain Neoplasms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ESTIMATED name: Intracranial Catheter Placement name: Lumbar Puncture name: Biopsy name: Biospecimen Collection name: Computed Tomography measure: Feasibility of Ommaya reservoir placement measure: Utility of Ommaya reservoir sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Terry C. Burns, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06322589 id: CMUH112-REC3-175 briefTitle: Evaluation of Human Efficacy of SOD Like Super Drink overallStatus: RECRUITING date: 2024-03-01 date: 2024-10-31 date: 2024-12-31 date: 2024-03-21 date: 2024-03-21 name: TCI Co., Ltd. class: INDUSTRY briefSummary: To assess the efficacy of SOD like Super Drink on anti-oxidant capacity, immuno regulation and skin for human conditions: Dermatology studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: SOD like Super Drink name: placebo drink measure: the volume of skin wrinkles measure: the roughness of skin texture measure: the change of skin elasticity measure: the change of Total Anti-oxidative Capacity (TAC) of blood measure: the change of Superoxide Dismutase (SOD) of blood measure: the change of Glutathione S-transferase (GST) of blood measure: the change of Glutathione (GSH) of blood measure: the change of Malondialdehyde (MDA) of blood measure: the change of immune-related cytokines of blood measure: the change of skin surface hydration measure: the change of skin Transepidermal Water Loss (TEWL) measure: the change of Skin Melanin Index measure: the change of Skin Erythema Index measure: The change of liver function biomarkers (AST, ALT) of blood measure: The change of renal function biomarkers (creatinine, BUN) of blood measure: The change of self-assessment skin condition and immuno condition sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China Medical University of department of cosmeceutics status: RECRUITING city: Taichung City zip: 406040 country: Taiwan name: Hsiu-Mei Chiang, Ph.D. role: CONTACT phone: +886-04-22053366 phoneExt: 5302 email: hmchiang@mail.cmu.edu.tw name: Ping Lin role: CONTACT phone: +886-02-879778111 email: candice.lin@tci-bio.com lat: 24.1469 lon: 120.6839 hasResults: False

 nctId: NCT06322576 id: IRB00347750 briefTitle: 177Lu-PSMA (177Lu-PNT2002) in PSMA-Positive Adenoid Cystic Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2030-12 date: 2035-12 date: 2024-03-21 date: 2024-03-22 name: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins class: OTHER name: Adenoid Cystic Carcinoma Research Foundation name: Progenics Pharmaceuticals, Inc. briefSummary: This is a single arm trial with one Cohort for people with recurrent or metastatic adenoid cystic carcinoma that cannot be treated with surgery. 10 participants will be enrolled in Cohort 1 at Johns Hopkins and will undergo DCFPyL PET/CT and 177Lu-PSMA dosimetry imaging only (single tracer dose). A feasibility analysis of dosimetry will be performed after meeting the accrual goal of Cohort 1 to determine if the study will proceed into Cohort 2.

If Cohort 2 proceeds, based on the dosimetry analysis, the major requirements of the study are to undergo treatment with 177Lu-PNT2002, have bloodwork, physical exams, and imaging done at study-specific time points, and to answer questionnaires. Patients will be in the study for about two years after enrolling. conditions: Adenoid Cystic Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Cohort 1of this study involves only Dosimetry for (10 patients).

(Cohort 2 may be added based on dosimetry analysis of Cohort 1. Planned Treatment for would be for 20 patients, single arm). primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: 177Lu-PNT2002 measure: Absorbed dose in tumor and normal organs measure: Objective response rate (ORR) by RECIST 1.1 measured in patients treated with 177Lu-PSMA for recurrent and metastatic ACC. measure: Stability of Disease: Proportion of patients with Stable Disease measure: Progression Free Survival measure: Overall Survival measure: Duration of Response measure: Xerostomia questionnaire (XQ) score measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins Hospital city: Baltimore state: Maryland zip: 21287 country: United States lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06322563 id: LTC004-202 briefTitle: Combination of LTC004 and Regorafenib to Treat Patients With Advanced/Metastatic CRC overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-01 date: 2025-03-01 date: 2024-03-21 date: 2024-03-21 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: This is a phase II clinical study to evaluate the safety, tolerability and preliminary antitumor activity of LTC004 in combination with regorafenib in patients with mCRC. A safety introductory trial was conducted to receive LTC004 in combination with regorafenib before starting the formal trial. After completing a 28-day safety assessment, safety will be confirmed before entering the formal trial phase. Further evaluation of the safety and efficacy of LTC004 in combination with regorafenib in the treatment of mCRC conditions: Advanced/Metastatic Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: LTC004+regorafenib measure: Treatment-Emergent Adverse Events-Safety and Tolerability measure: SAE-Safety and Tolerability measure: ORR measure: DCR measure: PFS measure: OS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Medical University Cancer Institute and Hospital city: Tianjin state: Tianjin zip: 300060 country: China lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06322550 id: beingapatient briefTitle: Influence of Role-expectancy on Patient Reported Outcomes Among Patients With Migraine: a Randomized Clinical Trial overallStatus: COMPLETED date: 2019-10-29 date: 2023-02-01 date: 2023-02-01 date: 2024-03-21 date: 2024-03-21 name: Universitätsklinikum Hamburg-Eppendorf class: OTHER briefSummary: This study was preregistered 2019 under https://osf.io/nczhj. Since JAMA requires a registration with ClinicalTrials.gov, we post-register the study here with the identical informations from OSF (see there)

Migraine is frequently associated with motion sickness, vestibular symptoms, and abnormal motion and visual processing. Clinical symptoms and underlying brain mechanisms during self-motion visual stimulation were not yet investigated in this population. Therefore the aim is to investigate the behavioral responses from a visually simulated roller coaster ride of patients with migraine and headache-free controls. In order to verify the effect of response bias, part of the patients with migraine will be informed that the study aims to investigate vestibular disorders instead of headache disorders and that they are invited as healthy controls. conditions: Role-expectancy on Patient Reported Outcomes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Monocenter, randomized, double blind, three-armed clinical trial primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: Double blind whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 366 type: ACTUAL name: cover story measure: self-reported vestibular symptoms measure: differences in motion sickness susceptibility using a standardized motion sickness questionnaire measure: differences in disability level using a standardized motion sickness questionnaire measure: differences in headache days per month measure: differences in headache burden and migraine disability questionnaires sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: UKE city: Hamburg zip: 20246 country: Germany lat: 53.57532 lon: 10.01534 hasResults: False

 nctId: NCT06322537 id: 23-5339 briefTitle: Albumin Utilization in Adult Cardiac Surgical Patients: Retrospective acronym: AlbACS-1R overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2025-11-01 date: 2025-11-01 date: 2024-03-21 date: 2024-03-21 name: University Health Network, Toronto class: OTHER name: Queen's University name: Unity Health Toronto name: McMaster University name: Sunnybrook Health Sciences Centre name: London Health Sciences Centre name: The Ottawa Hospital name: Vancouver General Hospital name: Royal Columbian Hospital name: Nova Scotia Health Authority briefSummary: All heart surgery patients universally require hydration, which is given through a vein in the arm, but practices for treating patients are not universal. There are disagreements about whether crystalloids should be used alone or in combination with albumin. This question has important implications because albumin is an expensive blood product in relatively limited supply, and 20% of its use is by heart surgery patients. The goal of this study is to learn more about how crystalloids and albumin are used during heart surgery, as well as, key patient outcomes. conditions: Cardiovascular Surgical Procedures conditions: Albumin studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 500 type: ESTIMATED measure: Albumin measure: Crystalloid, volume dose and type administered sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Columbian Hospital city: New Westminster state: British Columbia zip: V3L 3W7 country: Canada name: Michael Law, MD FRCPC role: CONTACT name: Ramanjot Kaur, MSc role: CONTACT lat: 49.20678 lon: -122.91092 facility: Vancouver General Hospital city: Vancouver, state: British Columbia zip: V5Z 1M9 country: Canada name: Darren Mullane, MB BCh BAO FRCPC FCAI FJFICM role: CONTACT lat: 49.24966 lon: -123.11934 facility: Nova Scotia Health Authority city: Halifax state: Nova Scotia zip: B3H 3A6 country: Canada name: Pieter de Jager role: CONTACT lat: 44.64533 lon: -63.57239 facility: McMaster University Medical Centre city: Hamilton state: Ontario country: Canada name: Michelle Zeller, MD FRCPC role: CONTACT lat: 43.25011 lon: -79.84963 facility: Kingston Health Sciences Centre city: Kingston state: Ontario zip: K7L 3N6 country: Canada name: Jeannie Callum, MD BA FRCPC role: CONTACT lat: 44.22976 lon: -76.48101 facility: London Health Science Centre city: London state: Ontario zip: N6A 5A5 country: Canada name: Christopher Harle, MD role: CONTACT name: Ziad Solh, MD MSc FRCPC role: CONTACT lat: 42.98339 lon: -81.23304 facility: University of Ottawa Heart Institute city: Ottawa state: Ontario zip: K1Y 4W7 country: Canada name: Diem Tran role: CONTACT name: Bernard McDonald role: CONTACT lat: 45.41117 lon: -75.69812 facility: Sunnybrook Health Sciences Centre city: Toronto state: Ontario zip: M4N 3M5 country: Canada name: Yulia Lin, MD FRCPC role: CONTACT lat: 43.70011 lon: -79.4163 facility: St. Michael's Hospital city: Toronto state: Ontario zip: M5B 1W8 country: Canada name: Katerina Pavenski, MD role: CONTACT lat: 43.70011 lon: -79.4163 facility: Toronto General Hospital - University Health Network city: Toronto state: Ontario zip: M5G 2C4 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06322524 id: FirstShanxiMU_jsk briefTitle: Study on Gamma Sensory Flicker for Insomnia overallStatus: COMPLETED date: 2021-05-01 date: 2022-03-30 date: 2022-12-30 date: 2024-03-21 date: 2024-03-21 name: The First Affiliated Hospital of Shanxi Medical University class: OTHER name: Shanxi Medical University briefSummary: This prospective observational study enrolled adult volunteers for a sleep quality research study through a questionnaire survey distributed via a WeChat two-dimensional code from May 2021 to April 2022. Participants were exposed to flicker stimulation through a light and sound device for a duration of 8 weeks with daily monitoring. conditions: Sleep Quality conditions: Sleep Duration conditions: Sleep Onset Latency studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 37 type: ACTUAL name: Gamma sensory flicker measure: Treatment adherence rate measure: Patient treatment adherence rate measure: Incidence rate of adverse reaction measure: Differences in sleep duration between the first and eighth weeks measure: Differences in sleep onset latencies between the first and eighth weeks measure: Differences in awakening times between the first and eighth weeks measure: pre-sleep efficiency. measure: post-sleep efficiency. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yong Xu city: Taiyuan state: Shanxi zip: 030000 country: China lat: 37.86944 lon: 112.56028 hasResults: False

 nctId: NCT06322511 id: HUS/7626/2023 briefTitle: Dialogical Family Guidance PostDoc Study acronym: DFG II overallStatus: RECRUITING date: 2024-01-02 date: 2027-12-31 date: 2027-12-31 date: 2024-03-21 date: 2024-03-21 name: Tampere University class: OTHER briefSummary: This new family intervention, called Dialogical Family Guidance (DFG) is developed to target family needs especially in families with a child with neurodevelopmental disorders. PhD study showed, that this intervention is functioning with this target group. Participants (families) experienced that they got information, guidance to ordinary life and that the DFG-therapists were listening to them and above all, helping with individual problems and questions. DFG include six meetings and professionals need to attend on a 3-day long education before using this intervention. conditions: Family Dynamics conditions: Family Relations conditions: Family Support studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Families attending the study Group I: receives Dialogical Family Guidance intervention and they fill questionnaires before and after the intervention.

Group II: Families do not receive Dialogical Family Guidance (but belong to the same focus group) primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Families include both parents and children. Parents fill the questionnaires, but all family members attend on the meetings during the intervention (six meetings). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 50 type: ESTIMATED name: Dialogical Family Guidance (DFG) measure: FAFHES measure: DFG-questionnaire measure: SDQ-p questionnaire (Strengths and difficulties regarding the child) sex: ALL minimumAge: 4 Years maximumAge: 13 Years stdAges: CHILD facility: Helsinki university hospital status: RECRUITING city: Helsinki zip: 00029 country: Finland lat: 60.16952 lon: 24.93545 hasResults: False

 nctId: NCT06322498 id: INFLAM.UTERUS-HMO-CTIL briefTitle: Inflammation Markers in Fluid Aspirate From a Scarred Uterine vs. a Normal Uterine Cavity overallStatus: RECRUITING date: 2023-01-18 date: 2024-12 date: 2024-12 date: 2024-03-21 date: 2024-03-21 name: Hadassah Medical Organization class: OTHER briefSummary: A prospective study that will take place in the hydrosonography clinic, comparing patients with an intact uterus to those who had a caesarean section. Eligible patients will preform a transvaginal ultrasound for evaluation of presence of a niche. After fixation of the transcervical catheter, we will flush 2 ml sterile NaCl 0.9% into the uterine cavity and aspirate the fluid. After collecting all samples, the samples will be snap frozen and stored at -80o C, until they undergo an immunological analysis. conditions: Infertility Due to Nonimplantation conditions: Infertility Secondary conditions: Cesarean Section Complications studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: Uterine lavage measure: Inflammatory cell population sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Hadassah Medical Organization status: RECRUITING city: Jerusalem country: Israel name: Hadas Lemberg, PhD role: CONTACT phone: 00 972 2 6777572 email: lhadas@hadassah.org.il name: Chana Adler Lazarovits, MD role: PRINCIPAL_INVESTIGATOR lat: 31.76904 lon: 35.21633 hasResults: False

 nctId: NCT06322485 id: P16.230 briefTitle: Online Self-management in Fibromyalgia overallStatus: COMPLETED date: 2017-01-25 date: 2021-01-26 date: 2021-01-26 date: 2024-03-21 date: 2024-03-21 name: Leiden University class: OTHER name: Fibrocentrum briefSummary: This study has been previously registered with the National Trial Registry (NTR6267) that has been cancelled. The registered trial has been automatically transferred to a new "Landelijk Trial Register", which does not contain all correct information on the current study and where no corrections can be made. Hence, the current study has been registered again with ClinicalTrials.gov.

The goal of this clinical trial is to study the effectiveness of an internet-based self-management intervention in adult patients with fibromyalgia. A randomized controlled trial (RCT) will be performed, in which 70 participants will be randomized to either the self-management intervention or a waitlist control condition (patients in the waitlist condition will receive the intervention after the intervention ends in the intervention group, i.e., after 6 months). The primary effect constitutes of the difference in change in pain coping between patients in the intervention and control condition from baseline to post-intervention. As secondary outcomes, a number of other psychological and physical outcome measures will be assessed (e.g., health-related quality of life, well-being, pain impact on daily life, pain cognitions). Also, cost-effectiveness of the intervention and the quality of the therapeutic relationship will be measured. conditions: Fibromyalgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE maskingDescription: Blinding of participants and practitioners is not possible due to the nature of the study. However, the statistician who creates the randomization schedule and performs statistical analyses is blinded to group allocation. count: 70 type: ACTUAL name: Internet-based self-management intervention measure: Change in pain coping measure: Change in well-being measure: Change in illness cognitions measure: Change in pain coping strategies measure: Change in Illness Perceptions measure: Change in pain measure: Change in pain interference in daily functioning and pain severity, and as exploratory measures support, life control, and affective distress measure: Change in health-related quality of life measure: Change in fibromyalgia impact measure: Change in health-related quality of life measure: Economic evaluation: Five-Level Version of the EQ-5D (EQ-5D-5L) measure: Economic evaluation: iMTA Medical Consumption Questionnaire (iMCQ) measure: Economic evaluation: iMTA Productivity Cost Questionnaire (iPCQ) measure: Patient satisfaction measure: Expected/perceived patient-provider interaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fibrocentrum city: Leiden state: Zuid-Holland zip: 2321 GL country: Netherlands lat: 52.15833 lon: 4.49306 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2022-07-25 uploadDate: 2023-11-27T05:27 filename: SAP_000.pdf size: 109827 hasResults: False

 nctId: NCT06322472 id: 138956 briefTitle: The Relationship Between Phonological Awareness Skills And Home Environment Literacy in Cochlear Implant Users overallStatus: COMPLETED date: 2021-01-10 date: 2021-05-24 date: 2022-02-12 date: 2024-03-21 date: 2024-03-21 name: Uskudar University class: OTHER briefSummary: The aim was to examine the relationship between home literacy of parents whose has children who use cohlear implant and family demographic characteristics and phonological awareness skills of children with cochlear implant. conditions: Cochlear Implants conditions: Child Language conditions: Literacy conditions: Phonological (Speech) Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Descriptive research primaryPurpose: DIAGNOSTIC masking: NONE count: 46 type: ACTUAL name: The Turkish Early Language Development Test (TEDIL) name: The Family Literacy Scale name: The Early Childhood Phonological Sensitivity Scale (PASECP) name: The Early Literacy Home Environment Scale (ELHES) name: Demographic Questionaries measure: The data the Early Childhood Phonological Sensitivity Scale (PASECP) from children with cochlear implants measure: The data Family Literacy Scale from parents measure: The data Early Literacy Home Environment Scale (ELVES) from parents sex: ALL minimumAge: 5 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Uskudar University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06322459 id: Junlong Zhang briefTitle: Effect of Sport Education on Physical Fitness and Learning Attitude Among Junior High School Students overallStatus: RECRUITING date: 2024-02-25 date: 2024-06-29 date: 2024-07-05 date: 2024-03-21 date: 2024-03-21 name: Universiti Putra Malaysia class: OTHER briefSummary: Since the outbreak of COVID-19, students; sports environment and time have been severely compressed, which has had an unprecedented impact on their physical fitness and sports learning attitude. Therefore, it is urgent to adopt an effective teaching mode that aligns with curriculum reform to improve students; physical quality and learning attitude. The Sports Education Model is one of the most popular teaching models in Western developed countries, but the application in China and the related evidence of improving students; physical quality and learning attitude towards sports are relatively scarce. This study compares and analyzes the influence of the Sports Education Model and Traditional Teaching on junior middle school students; physical fitness and learning attitude, aiming to provide theoretical support for improving students; physical fitness and learning attitude and promoting the Sports Education Model in China. Promote the healthy development of junior middle school students. conditions: Physical Fitness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Employing a Cluster randomized controlled experiment design, the experimental and control groups were randomly assigned to two different schools. Students participated in the Sport Education Model (experimental group) and traditional teaching (control group). primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: Sport Education Curriculum name: Normal teaching measure: Cardiovascular fitness test measure: Flexibility test measure: Speed test sex: ALL minimumAge: 13 Years maximumAge: 15 Years stdAges: CHILD facility: The 19th Middle School status: RECRUITING city: Qinhuangdao state: Hebei zip: 066000 country: China name: Junlong Zhang, PHD role: CONTACT phone: 0397698153 email: zhangjunlong2413@gmail.com name: Gege Yao, Master role: CONTACT name: Junlong Zhang role: PRINCIPAL_INVESTIGATOR lat: 39.93167 lon: 119.58833 hasResults: False

 nctId: NCT06322446 id: PI23/00299 briefTitle: Exercise in People With Cystic Fibrosis on CFTR Modulator Therapy acronym: FIQMODE overallStatus: RECRUITING date: 2024-02-27 date: 2025-12-23 date: 2025-12-23 date: 2024-03-21 date: 2024-03-21 name: Universidad Politecnica de Madrid class: OTHER name: Carlos III Health Institute name: Universidad Europea de Madrid name: Hospital Universitario La Paz name: Hospital Universitario Ramon y Cajal name: Hospital Infantil Universitario Niño Jesús, Madrid, Spain briefSummary: Recently, the treatment of Cystic Fibrosis (CF) incorporated new modulators/enhancers of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR). It is thus increasingly important to study the side effects of these drugs, their extrapulmonary effects and possible interaction with other drugs and with exercise. For this purpose, a randomized controlled trial is proposed to determine the effects of a telematic exercise intervention on muscle health, in a group of 48 children and adolescents with CF treated with these new generation CFTR modulators. They will be randomly assigned to two groups (exercise and control group). The effect of the intervention will be analysed measuring the variables of muscle health, cardiorespiratory fitness, lung function, body composition, inflammatory biomarkers and miRNAs. After completion of the intervention program, adherence to exercise and clinical evolution after one year will be analysed. conditions: Cystic Fibrosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Exercise measure: Changes in peripheral muscle strength measure: Changes in inspiratory/expiratory muscle strength (MIP/MEP) (cmH2O) measure: Changes in functional capacity: lower limbs power capacity measure: Changes in functional capacity: walking capacity measure: Change in Cardiorespiratory fitness: maximal oxygen consumption measure: Change in Cardiorespiratory fitness: Ventilatory threshold VT1 measure: Changes in Pulmonary Function: forced vital capacity (FVC) measure: Changes in Pulmonary Function: Forced expiratory volume in the first second (FEV1) measure: Changes in the anthropometric and body composition: Weight measure: Changes in the anthropometric and body composition: Height measure: Changes in the anthropometric and body composition: BMI measure: Changes in body composition: Total fat mass measure: Changes in body composition: FMI measure: Changes in body composition: lean mass kg measure: Changes in body composition: lean mass % measure: Changes in quality of life using the Cystic Fibrosis Questionnaire measure: Changes in plasma levels muscle damage biomarkers measure: Changes in plasma levels of inflammation: hs-CRP measure: Changes in plasma levels of inflammation: Interleukins sex: ALL minimumAge: 6 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT facility: Facultad de Ciencias de la Actividad Física y Deporte - INEF UPM status: RECRUITING city: Madrid zip: 28040 country: Spain name: Marcela González Gross, PhD role: CONTACT phone: +34910677980 email: marcela.gonzalez.gross@upm.es name: Margarita M Pérez-Ruiz, PhD role: PRINCIPAL_INVESTIGATOR name: Marcela González-Gross, PhD role: SUB_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06322433 id: 37C301 briefTitle: Follow up of High Myopic Eyes acronym: FWUPMIOPIA_ E overallStatus: RECRUITING date: 2023-11-01 date: 2024-11-01 date: 2025-11-01 date: 2024-03-21 date: 2024-03-21 name: Istituto Auxologico Italiano class: OTHER briefSummary: In this non-interventional retrospective and prospective observational study, the long-term evolution of clinical and iconographic characteristics of patients with pathological myopia will be considered Changes of some specific clinical, tomographic and angiographic variables evaluated on the baseline and after a minimum of 5 years follow-up will be studied. conditions: Pathologic Myopia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 138 type: ESTIMATED name: no drugs used for this study measure: Proportion of subjects with neovascularization at follow-up visit sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano IRCCS status: RECRUITING city: Milan zip: 20145 country: Italy name: Paolo Milani, MD role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06322420 id: MoodHab briefTitle: Behavioral Activation for Depression and Habitual Rumination acronym: MoodHab overallStatus: RECRUITING date: 2024-02-09 date: 2025-07-01 date: 2026-02-01 date: 2024-03-21 date: 2024-03-21 name: Ragnar Pétur Ólafsson class: OTHER name: The Icelandic Centre for Research briefSummary: Depressive rumination, a negative thinking style characterized by repetitive and passive thoughts about the causes, meanings, and consequences of one's feelings and distress, is often described as being a habitual response tendency that forms a vulnerability to depression. Behavioural Activation (BA) is an effective treatment for depression but little is known of mechanisms of changes during a successful treatment completion and for whom the treatment benefits the most. The main purpose of the study is to investigate whether habit-like mood-reactive rumination will change during Behavioral Activation treatment for current depression and mediates symptom changes in the treatment. Important moderators of change will also be investigated (i.e. history of early life stress and cognitive flexibility). We aim to provide individual BA treatment for up to 130 currently depressed participants in 12 treatment sessions over 11 weeks. Measures are obtained at pre-treatment, during treatment, at post-treatment and at 6 month follow up. conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: Behavioural Activation (BA) measure: Symptom severity measured by the BDI-2 measure: Disorder severity assessed with the DIAMOND diagnostic interview - Major Depressive Disorder measure: Diagnostic status assessed with the DIAMOND diagnostic interview - Major Depressive Episode measure: Symptom severity measured on the PHQ-9 measure: Momentary negative and positive affectivity using items from the PANAS (Positive and Negative Affect Schedule) measure: Diagnostic status assessed with the DIAMOND diagnostic interview at follow -up - Major Depressive Episode measure: Diagnostic status assessed with the DIAMOND diagnostic interview at follow-up- Major Depressive Disorder measure: The Quality of Life Scale (QOLS) measure: Generalized Anxiety Disorder-7 (GAD-7) measure: The Snaith-Hamilton Pleasure Scale (SHAPS) measure: Beck Anxiety Inventory (BAI) measure: The Ruminative Response Scale (RRS) measure: The Pearlin Mastery Scale (PMS) measure: The Environmental Reward Observation Scale (EROS) measure: Behavioral Activation for Depression Scale (BADS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Iceland status: RECRUITING city: Reykjavík zip: 102 country: Iceland name: Ragnar P Ólafsson, PhD role: CONTACT phone: 8622245 phoneExt: 00354 email: ragnarpo@hi.is name: Sigurður Viðar, Cand.Psych role: SUB_INVESTIGATOR name: Nína B Arnardóttir, MS role: SUB_INVESTIGATOR name: Ívar Snorrason, PhD role: SUB_INVESTIGATOR name: Igor Marchetti, PhD role: SUB_INVESTIGATOR lat: 64.13548 lon: -21.89541 hasResults: False

 nctId: NCT06322407 id: KY2023-263-03-02 briefTitle: Ultrasound-guided Stellate Ganglion Block for Treatment of Chronic Migraine in Adult overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2025-12 date: 2024-03-21 date: 2024-03-21 name: Beijing Tiantan Hospital class: OTHER briefSummary: To assess the 6-months effects and safety of stellate ganglion block(SGB) for Chronic Migraine (CM) patients who failure to undergo preventive therapy and are seeking a more suitable non-pharmacological therapy. conditions: Chronic Migraine studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Single (Outcomes Assessor) whoMasked: OUTCOMES_ASSESSOR count: 206 type: ESTIMATED name: Stellate Ganglion Block (SGB) name: standardized drug treatment measure: the change from baseline in mean monthly migraine days measure: Proportion of patients achieved≥50% reduction in monthly migraine days measure: Total effective rate measure: The mean Numeric Rating Scale(NRS) score during headache attack measure: Patients satisfaction (PS) measure: The six item headache impact test (HIT-6) measure: the Migraine Disability Assessment score(MIDAS) measure: The Pittsburgh Sleep Quality Index (PSQI) measure: adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tiantan Hospital city: Beijing state: Beijing zip: 100050 country: China name: Fang Luo, M.D role: CONTACT phone: +86 13611326978 email: 13611326978@163.com name: Lu Liu role: CONTACT phone: +86 18618418228 email: emmaliulu@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06322394 id: BXOS110-Ⅱ-2023-12 briefTitle: BXOS110 Injection in the Treatment of Acute Ischaemic Stroke overallStatus: RECRUITING date: 2024-02-07 date: 2025-03 date: 2025-09 date: 2024-03-21 date: 2024-03-21 name: Biocells (Beijing) Biotech Co.,Ltd class: INDUSTRY briefSummary: The purpose of this study was to evaluate the effectiveness of early administration of BXOS110 for injection in reducing overall disability in patients with acute ischaemic stroke. conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: high-dose BXOS110 name: low-dose BXOS110 name: Placebo measure: Proportion of subjects with mRS score 0-2 on day 90 measure: Proportion of subjects with mRS score 0-1 on day 90 measure: Day 90 mRS Displacement Analysis measure: Proportion of subjects with NIHSS scores ≤1 on day 10 (or at discharge) measure: Proportion of subjects with a ≥4-point reduction in NIHSS score from baseline at day 10 (or at discharge) measure: Proportion of subjects with ≥4 point increase in NIHSS score during hospitalisation measure: Proportion of subjects with Barthel Index Scale (BI) scores ≥95 on day 90 measure: Day 90 European Five Dimensional Health Scale (EQ-5D) Score measure: Mortality due to stroke within 90 days measure: Change in infarct volume from baseline after 24 hours of dosing sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yuebei People's Hospital status: NOT_YET_RECRUITING city: Shaoguan state: Guangdong country: China name: Junbin Chen role: CONTACT phone: 86-13500205898 email: cjbcl0397@163.com lat: 24.8 lon: 113.58333 facility: Harrison International Peace Hospital status: NOT_YET_RECRUITING city: Hengshui state: Hebei country: China name: Yan Wei role: CONTACT phone: 86-18003188568 email: Hayuanwy@163.com lat: 37.73222 lon: 115.70111 facility: The First Hospital of Hebei Medical University status: NOT_YET_RECRUITING city: Shijiazhuang state: Hebei country: China name: Xiaoyun Liu role: CONTACT phone: 86-13191887318 email: a331083909@126.com lat: 38.04139 lon: 114.47861 facility: Daqing Oilfield General Hospital status: NOT_YET_RECRUITING city: Daqing state: Heilongjiang country: China name: Dan Deng role: CONTACT phone: 86-18245977799 email: 707604206@qq.com lat: 46.58333 lon: 125.0 facility: Anyang People's Hospital status: NOT_YET_RECRUITING city: Anyang state: Henan country: China name: Jiangang Zhang role: CONTACT phone: 86-13513722532 email: 709705699@qq.com lat: 36.096 lon: 114.38278 facility: Nanshi Hospital of Nanyang status: NOT_YET_RECRUITING city: Nanyang state: Henan country: China name: Guang Wu role: CONTACT phone: 86-13525687571 email: seizelinni@163.com lat: 32.99472 lon: 112.53278 facility: Nanyang Second General Hospital status: NOT_YET_RECRUITING city: Nanyang state: Henan country: China name: Ming Wang role: CONTACT phone: 86-15139096969 email: 15139096969@163.com lat: 32.99472 lon: 112.53278 facility: The First Affiliated Hospital of Nanyang Medicinal College status: NOT_YET_RECRUITING city: Nanyang state: Henan country: China name: Tao Feng role: CONTACT phone: 86-15638996063 email: 631740898@qq.com lat: 32.99472 lon: 112.53278 facility: MeiHekou Central Hospital status: NOT_YET_RECRUITING city: Meihekou state: Jilin country: China name: Hong Yu role: CONTACT phone: 86-13844564195 email: 2823974848@qq.com lat: 42.52722 lon: 125.67528 facility: Beipiao Central Hospital status: RECRUITING city: Chaoyang state: Liaoning country: China name: Yutong Ma role: CONTACT phone: 86-18642143339 email: myt3339@163.com lat: 41.57028 lon: 120.45861 facility: Ceneral Hospital of Mining Industry Group Fuxin status: NOT_YET_RECRUITING city: Fuxin state: Liaoning country: China name: Yingjie Duan role: CONTACT phone: 86-13470363261 email: 451142359@qq.com lat: 42.01556 lon: 121.65889 facility: The Affiliated Hospital of Shenyang Medical College status: NOT_YET_RECRUITING city: Shenyang state: Liaoning country: China name: Runhui Li role: CONTACT phone: 86-18002477116 email: lirh710717@163.com lat: 41.79222 lon: 123.43278 facility: The First People's Hospital of Shenyang status: NOT_YET_RECRUITING city: Shenyang state: Liaoning country: China name: Tie Sui role: CONTACT phone: 86-13998352587 email: jakeyisui@icloud.com lat: 41.79222 lon: 123.43278 facility: The People's Hospital of Liaoning Province status: NOT_YET_RECRUITING city: Shenyang state: Liaoning country: China name: Qiu He role: CONTACT phone: 86-17702589222 email: qiuhe6392@sina.com lat: 41.79222 lon: 123.43278 facility: Iron Coal General Hospital of Liaoning Health Industry Group status: NOT_YET_RECRUITING city: Tieling state: Liaoning country: China name: Yu Wang role: CONTACT phone: 86-13188417658 email: fffoo@sina.com lat: 42.29306 lon: 123.84139 facility: Keshketengqi Hospital of Traditional Chinese Medicine and Mongolian Medicine status: RECRUITING city: Chifeng state: Neimenggu country: China name: Guozhi Lu role: CONTACT phone: 86-13722169555 email: gz9555@sina.com lat: 42.26833 lon: 118.96361 facility: Xianyang Hospital of Yan'an University status: NOT_YET_RECRUITING city: Xianyang state: Shaanxi country: China name: Wen Liu role: CONTACT phone: 86-18740505535 email: 174461442@qq.com lat: 34.33778 lon: 108.70261 facility: Liaocheng People's Hospital status: NOT_YET_RECRUITING city: Liaocheng state: Shandong country: China name: Cunju Guo role: CONTACT phone: 86-13346256168 email: cunjuguo@163.com lat: 36.45596 lon: 115.97766 facility: Linyi People's Hospital status: NOT_YET_RECRUITING city: Linyi state: Shandong country: China name: Ziran Wang role: CONTACT phone: 86-13954993801 email: wzr0806@163.com lat: 35.06306 lon: 118.34278 facility: Tengzhou Central People's Hospital status: NOT_YET_RECRUITING city: Tengzhou state: Shandong country: China name: Deyang Li role: CONTACT phone: 86-13561190369 email: lideyang0632@163.com lat: 35.08357 lon: 117.19071 facility: Sinopharm Tongmei General Hospital status: NOT_YET_RECRUITING city: Datong state: Shanxi country: China name: Junhai Wang role: CONTACT phone: 86-13753265757 email: wjh1964@sohu.com lat: 40.09361 lon: 113.29139 facility: Linfen Central Hospital status: RECRUITING city: Linfen state: Shanxi country: China name: Hongguo Dai role: CONTACT phone: 86-15935767592 email: daihongguo3199@163.com lat: 36.08889 lon: 111.51889 facility: Linfen People's Hospital status: NOT_YET_RECRUITING city: Linfen state: Shanxi country: China name: Junfang Hao role: CONTACT phone: 86-13835360973 email: haojunfang2012@163.com lat: 36.08889 lon: 111.51889 facility: Beijing Tiantan Hospital , Capital Medical University status: NOT_YET_RECRUITING city: Beijing country: China name: Yongjun Wang role: CONTACT phone: 86-13911172565 email: yongjunwang111@aliyun.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06322381 id: Reinsertion AT VS ZO in IAT briefTitle: Reinsertion Achilles Tendon VS Zadek Osteotomy in Insertional Achilles Tendinopathy overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-04 date: 2024-03-21 date: 2024-03-21 name: Assiut University class: OTHER briefSummary: The aim of this study is to Compare functional outcome and the recovery time of reinsertion of achilles tendon VS zadek osteotomy in insertional achilles tendinopathy. conditions: Insertional Achilles Tendinopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 42 type: ESTIMATED name: Reinsertion achilles tendon name: Zadek osteotomy measure: the time needed to return to normal daily activities (functional outcome) assessed by foot and ankle outcome score. measure: Pain assessed by the visual analogue scale. measure: Rate of complications sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06322368 id: DF002 briefTitle: Myofunctional and Respiratory Intervention on Phonation in Stroke overallStatus: RECRUITING date: 2023-12-01 date: 2024-05-01 date: 2024-07-01 date: 2024-03-21 date: 2024-03-21 name: Universidad de Granada class: OTHER briefSummary: Patients with stroke frequently present phonation difficulties. An intervention combining myofunctional and respiratory training is presented in order to improve phonation outcomes. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Myofunctional and respiratory training program name: Range of motion and thermal and mechanical stimulation exercising measure: Volume during monologue measure: Frequency during monologue measure: Volumen during sustained phonation of /s/ sound measure: Communication effectiveness Index measure: Frequency during sustained phonation of /s/ sound measure: Volumen during sustained phonation of /a/ sound measure: Frequency during sustained phonation of /a/ sound sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Health Sciences status: RECRUITING city: Granada zip: 18016 country: Spain name: Irene Cabrera Martos role: CONTACT email: irenecm@ugr.es role: CONTACT phoneExt: Cabrera Martos email: irenecm@ugr.es name: Irene Cabrera Martos role: PRINCIPAL_INVESTIGATOR lat: 37.18817 lon: -3.60667 hasResults: False

 nctId: NCT06322355 id: ZSUFR01 briefTitle: Comparison of UFR With QFR in Stable Coronary Artery Disease overallStatus: COMPLETED date: 2018-07-01 date: 2023-12-31 date: 2023-12-31 date: 2024-03-21 date: 2024-03-21 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: Quantitative flow reserve (QFR), derived from coronary angiography, has shown high accuracy in detecting significant lesions. Ultrasonic flow ratio (UFR), a new development from IVUS, integrates physiological estimation with intravascular imaging. Although both QFR and UFR are effective, there's no conclusive evidence favoring one over the other. The study aims to compare UFR and QFR's diagnostic performance against the conventional FFR standard in detecting significant coronary lesions. conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 250 type: ACTUAL name: Coronary angiography, Fractional Flow Reserve measurement, Intravascular ultrasound measure: Compare diagnostic performance of QFR with UFR measure: Correlation and agreement between QFR and UFR sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Hospital, Fudan University city: Shanghai zip: 210000 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06322342 id: RVL-102-23 id: 9R44CA261240-04A1 type: NIH link: https://reporter.nih.gov/quickSearch/9R44CA261240-04A1 briefTitle: Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent overallStatus: RECRUITING date: 2024-04 date: 2025-02 date: 2025-03 date: 2024-03-21 date: 2024-04-09 name: Reveal Pharmaceuticals Inc. class: INDUSTRY name: National Cancer Institute (NCI) briefSummary: The Phase 2 trial will assess safety, tolerability, efficacy, imaging pharmacodynamics, and pharmacokinetics of RVP-001, a novel manganese-based MRI contrast agent, at three escalating dose levels when administered as a single IV bolus to subjects with known gadolinium-enhancing central nervous system (CNS) lesions who have recently had a gadolinium-based contrast agent (GBCA)-enhanced MRI of the brain. conditions: Central Nervous System (CNS) Lesions studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: RVP-001 measure: Adverse Events measure: Lesion visualization criteria for RVP-001 enhanced MRI compared to unenhanced MRI measure: Lesion visualization criteria for RVP-001 compared to gadolinium-based contrast agent (GBCA) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yale New Haven Hospital status: NOT_YET_RECRUITING city: New Haven state: Connecticut zip: 06510 country: United States name: Kristin DeFancesco role: CONTACT phone: 203-785-3852 email: kristin.defrancesco@yale.edu name: Amit Mahajan, MD role: PRINCIPAL_INVESTIGATOR lat: 41.30815 lon: -72.92816 facility: Massachusetts General Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Abi Akinniyi role: CONTACT phone: 781-513-0207 email: aakinniyi@mgb.org name: John Chen, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Brigham & Women's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Cora Nicoll role: CONTACT phone: 617-525-3161 email: cnicoll1@bwh.harvard.edu name: Mathew DeSalvo, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Duke University Medical Center status: RECRUITING city: Durham state: North Carolina zip: 27710 country: United States name: Helen Zuleta role: CONTACT phone: 919-613-0226 email: helen.zuleta@duke.edu name: Shruti Raja, M.D. role: PRINCIPAL_INVESTIGATOR lat: 35.99403 lon: -78.89862 hasResults: False

 nctId: NCT06322329 id: K 2023-10103 briefTitle: RealMove (Lung): Assessing Tumour Motion With Dynamic MRI acronym: RealMove(lung) overallStatus: RECRUITING date: 2024-03-15 date: 2026-03-17 date: 2036-03-17 date: 2024-03-21 date: 2024-03-21 name: Region Stockholm class: OTHER_GOV name: Uppsala University Hospital briefSummary: The study aims to develop an improved method to tailor the geometric safety margin when treating with stereotactic body radiotherapy (SBRT), to avoid tumour cells being missed during irradiation and to limit the exposure of normal tissues as much as possible. Dynamic magnetic resonance imaging (MRI) is assumed to represent the tumour motion during the respiratory cycle more realistically, compared to 4-dimensional computed tomography (4D CT), thanks to its high temporal resolution and the possibility to image the motion over a longer period of time. Patients receiving SBRT for a pulmonary target located below the level of the carina are included in the study, and the hypothesis will be tested through a comparison of the tumour amplitude measured with each modality. Furthermore, the predictive value of the image series acquired at treatment planning, for the motion patterns observed at each treatment fraction, will be evaluated through repeated 4D CBCT acquisitions. conditions: Lung Tumor studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Dynamic MRI measure: Difference in amplitude of the tumour motion, as assessed by dynamic MRI and 4D CT, respectively measure: Difference in amplitude of the tumour motion, assessed at different times (using dynamic MRI and 4D CBCT) measure: Difference in the structure of the probability density function, assessed at different times measure: Anxiety during examinations of tumour motion measure: Overall survival measure: Progression-free survival measure: Grade ≥2 toxicity assessed by CTCAE v.5.0 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karolinska University Hospital status: RECRUITING city: Stockholm zip: 17176 country: Sweden name: Eva Onjukka, PhD role: CONTACT phone: +46765696744 email: eva.onjukka@ki.se name: Mattias Hedman, MD/PhD role: CONTACT phone: +46812370000 email: mattias.hedman@regionstockholm.se lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06322316 id: MS-492-2022 briefTitle: Analgesic Efficacy of U/S Retrolaminar Block and Erector Spinae Plane Block in MRM overallStatus: COMPLETED date: 2022-10-01 date: 2023-03-01 date: 2023-04-01 date: 2024-03-21 date: 2024-03-21 name: National Cancer Institute, Egypt class: OTHER briefSummary: Modified radical mastectomy (MRM) is the most commonly performed surgical procedure in breast cancer patients and is usually associated with severe postoperative pain. The peripheral nerve block techniques were suggested to reduce acuter post-mastectomy pain. The study compared the analgesic efficacy of retrolaminar block (RLB) and ESPB in patients undergoing MRM. conditions: Breast Neoplasms conditions: Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: To determine the analgesic effect of ultrasound guided Retrolaminar Block and Erector Spinae Plane Block in patients undergoing modified radical mastectomy regarding the following : 1-Post-operative opioid (morphine) consumption in the 1st 24 hours 2- Postoperative Numeric Pain Rating Scale. 3. Effect on hemodynamics: Mean arterial blood pressure and Heart rate. 4. Intraoperative fentanyl consumption. 5. Duration of analgesic effect primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The patients will be randomly assigned into two equal comparable groups using computer- generated random numbers in opaque closed envelopes, each of which will include 30 patients. Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ACTUAL name: The Ultrasound-guided Retrolaminar Block Group name: The Ultrasound-guided Erector Spinae Plane Block Group measure: the total morphine consumed postoperatively for 24 hours measure: the total intraoperative fentanyl consumption measure: duration of analgesia measure: postoperative nausea and vomiting PONV as side effect of morphine sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National cancer Insititute Cairo university city: Cairo zip: 11796 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06322303 id: C-EXP-194-UGR23 briefTitle: Effect of Cannabidiol (CBD) on Vision and Driving overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-01 date: 2023-09-30 date: 2025-12-31 date: 2024-03-21 date: 2024-03-22 name: Universidad de Granada class: OTHER briefSummary: The use of cannabis with ∆9-tetrahydrocannabinol (THC) content has been shown to have negative effects on vision and driving. The use of other cannabinoids, such as cannabidiol (CBD), which is not attributed with a psychoactive effect, is increasing significantly. This project aims to investigate whether consuming CBD can negatively affect visual function by assessing a wide range of visual parameters and whether these changes may pose a risk for everyday activities such as driving. conditions: Cannabis Use studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Placebo (CBD 0%) name: CBD 15% name: CBD 30% measure: Change in Overall Driving Performance Score (ODPS) after cannabidiol vaporization measure: Change in motion detection sensitivity after cannabidiol vaporization measure: Change in contrast sensitivity after cannabidiol vaporization measure: Change in visual acuity after cannabidiol vaporization measure: Change in fixations after cannabidiol vaporization measure: Driving simulator: standard deviation of the lateral lane position (SDLP) measure: Distance travelled outside the lane measure: Mean speed measure: Angular velocity of the steering wheel sex: ALL minimumAge: 18 Years maximumAge: 43 Years stdAges: ADULT facility: University of Granada city: Granada zip: 18071 country: Spain lat: 37.18817 lon: -3.60667 hasResults: False

 nctId: NCT06322290 id: SEMBAI briefTitle: Epidemiological Study on Invasive Bacterial Diseases overallStatus: RECRUITING date: 2021-12-09 date: 2031-12-30 date: 2032-03-30 date: 2024-03-21 date: 2024-03-21 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Streptococcus pneumoniae (pneumococcus), Neisseria meningitidis (meningococcus), and Haemophilus influenzae (hemophilus) are among the main bacteria responsible for invasive bacterial diseases (MBIs) that result in severe clinical pictures also characterized by a high frequency of serious complications. Surveillance of infections caused by these pathogens and their distribution by serotypes/serogroups is essential to guide public health interventions, assess epidemiologic trends, monitor any secondary cases, estimate the proportion of preventable cases, identify any vaccine failures, and evaluate the impact of vaccine strategies.The present study aims to study the epidemiology of invasive bacterial diseases, characterize the circulating strains also in order to plan treatment and prevention strategies. conditions: Invasive Bacterial Diseases (IBD) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 5000 type: ESTIMATED name: assessment of pathogens in blood specimens measure: Incidence rate of Infective Bacterial Diseases from Streptococcus pneumoniae (pneumococcus) during the study period in pediatric age. measure: Incidence rate of of Infective Bacterial Diseases cases from Neisseria meningitidis during the study period in pediatric age. measure: Incidence rate of Infective Bacterial Diseases cases from Haemophilus influenzae during the study period in pediatric age. measure: Frequency of circulating serogroups/serotypes in Italy for S.pneumoniae, N.meningitidis, H.influenzae. measure: Proportion of these invasive infections (S.pneumoniae, N.meningitidis, H.influenzae) that are preventable by vaccine in Italy measure: Vaccine failure rate for S.pneumoniae, N.meningitidis, and H.influenzae. sex: ALL minimumAge: 1 Day maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale di Adria status: NOT_YET_RECRUITING city: Adria country: Italy lat: 45.05445 lon: 12.05599 facility: Ospedali riuniti di Ancona status: NOT_YET_RECRUITING city: Ancona country: Italy lat: 43.5942 lon: 13.50337 facility: Ospedale di Andria status: NOT_YET_RECRUITING city: Andria country: Italy lat: 41.23117 lon: 16.29797 facility: Ospedale Giovanni XXIII status: NOT_YET_RECRUITING city: Bari country: Italy lat: 41.11148 lon: 16.8554 facility: Policlinico S.Orsola-Malpighi IRCCS status: NOT_YET_RECRUITING city: Bologna country: Italy lat: 44.49381 lon: 11.33875 facility: Fondazione poliambulanza Brescia status: NOT_YET_RECRUITING city: Brescia country: Italy lat: 45.53558 lon: 10.21472 facility: Ospedale Giovanni XXIII status: NOT_YET_RECRUITING city: Brescia country: Italy lat: 45.53558 lon: 10.21472 facility: Ospedale di Campobasso status: NOT_YET_RECRUITING city: Campobasso country: Italy lat: 41.55947 lon: 14.66737 facility: Ospedale Camposampiero status: NOT_YET_RECRUITING city: Camposampiero country: Italy lat: 45.56368 lon: 11.93534 facility: Ospedale di Esine asst Valcamonica status: NOT_YET_RECRUITING city: Esine country: Italy lat: 45.92515 lon: 10.25102 facility: Ospedale di Feltre (AULSS 1 Dolomiti) status: NOT_YET_RECRUITING city: Feltre country: Italy lat: 46.02085 lon: 11.90031 facility: Immunology Laboratory Meyer Children's Hospital IRCCS status: RECRUITING city: Florence country: Italy name: Chiara Azzari, MD role: CONTACT phone: 00390555662542 lat: 43.77925 lon: 11.24626 facility: Ospedale Morgagni status: NOT_YET_RECRUITING city: Forlì country: Italy lat: 44.22177 lon: 12.04144 facility: AO Salvini di Garbagnate status: NOT_YET_RECRUITING city: Garbagnate country: Italy lat: 45.77027 lon: 9.29848 facility: Azienda sanitaria universitaria Giuliano Isontina (ASU GI) status: NOT_YET_RECRUITING city: Gorizia country: Italy lat: 45.94088 lon: 13.62167 facility: Ospedale di Macerata status: NOT_YET_RECRUITING city: Macerata country: Italy lat: 43.29789 lon: 13.45293 facility: Ospedale di Magenta status: NOT_YET_RECRUITING city: Magenta country: Italy lat: 45.46456 lon: 8.88453 facility: Azienda Ospedaliera Policlinico Universitario "G. Martino" status: NOT_YET_RECRUITING city: Messina country: Italy lat: 38.19394 lon: 15.55256 facility: IRCCS San Raffaele status: NOT_YET_RECRUITING city: Milano country: Italy lat: 45.46427 lon: 9.18951 facility: AORN Santobono status: NOT_YET_RECRUITING city: Napoli country: Italy lat: 40.85216 lon: 14.26811 facility: AOU Federico II di Napoli status: NOT_YET_RECRUITING city: Napoli country: Italy lat: 40.85216 lon: 14.26811 facility: Ospedale di Novara status: NOT_YET_RECRUITING city: Novara country: Italy lat: 45.44694 lon: 8.62118 facility: Fondazione I.R.C.C.S. Policlinico San Matteo status: NOT_YET_RECRUITING city: Pavia country: Italy lat: 45.19205 lon: 9.15917 facility: Ospedale spirito santo di Pescara status: NOT_YET_RECRUITING city: Pescara country: Italy lat: 42.4584 lon: 14.20283 facility: Azienda sanitaria Friuli occidentale status: NOT_YET_RECRUITING city: Pordenone country: Italy lat: 45.95689 lon: 12.66051 facility: Ospedale degli infermi status: NOT_YET_RECRUITING city: Rimini country: Italy lat: 44.05755 lon: 12.56528 facility: Ospedale Pediatrico Bambin Gesù IRCCS status: NOT_YET_RECRUITING city: Roma country: Italy lat: 41.89193 lon: 12.51133 facility: Ospedale Sandro Pertini status: NOT_YET_RECRUITING city: Roma country: Italy lat: 41.89193 lon: 12.51133 facility: Ospedale San Leonardo di Salerno status: NOT_YET_RECRUITING city: Salerno country: Italy lat: 40.67545 lon: 14.79328 facility: Ospedale di Saronno status: NOT_YET_RECRUITING city: Saronno country: Italy lat: 45.62513 lon: 9.03517 facility: AOU Sassari status: NOT_YET_RECRUITING city: Sassari country: Italy lat: 40.72586 lon: 8.55552 facility: Ospedale di Scorrano status: NOT_YET_RECRUITING city: Scorrano country: Italy lat: 40.09018 lon: 18.29993 facility: ASP Trapani status: NOT_YET_RECRUITING city: Trapani country: Italy lat: 38.0176 lon: 12.53617 facility: IRCCS Materno Infantile Burlo Garofolo status: NOT_YET_RECRUITING city: Trieste country: Italy lat: 45.64953 lon: 13.77679 facility: Azienda sanitaria universitaria Friuli Centrale (ASU FC) status: NOT_YET_RECRUITING city: Udine country: Italy lat: 46.0693 lon: 13.23715 facility: Azienda ospedaliera universitaria integrata Verona status: NOT_YET_RECRUITING city: Verona country: Italy lat: 45.4299 lon: 10.98444 facility: Ospedale civile di Vibo Valentia status: NOT_YET_RECRUITING city: Vibo Valentia country: Italy lat: 38.67618 lon: 16.10094 facility: Ospedale Maggiore Carlo Alberto Pizzardi status: NOT_YET_RECRUITING city: Bologna state: Ì country: Italy lat: 44.49381 lon: 11.33875 hasResults: False

 nctId: NCT06322277 id: NETVAC briefTitle: Use of Low-cost Molecular Diagnostic Techniques as a New Surveillance Model for Diseases Preventable by Vaccinations. overallStatus: RECRUITING date: 2021-05-04 date: 2025-02-28 date: 2025-03-31 date: 2024-03-21 date: 2024-03-21 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Vaccine-preventable disease (VPD) surveillance should be a priority throughout the world. In Italy, however, there is limited attention to the epidemiology of VPDs, with the consequence that their incidence is largely underestimated. Although notification of vaccine-preventable diseases is mandatory, very often the etiologic agents causing VPDs are not identified the etiological agents causing the major and most severe infectious diseases in childhood. Several reasons underlie the underestimation. For example, not having a good surveillance system does not allow us to organize a sustainable prevention project for example based on on the introduction of new vaccinations. For example the limited use of low-cost high-sensitivity techniques such as real-time PCR, which could, if more widely used, improve pathogen identification with 3 times the sensitivity of standard cultural methods. Therefore, the idea of this multicenter, biological sample study is to take advantage of the regional pediatric network with the goal of improving VPD surveillance and increase awareness of the importance of surveillance of preventable diseases with the vaccine within the pediatric network. conditions: Bacterial Infections studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 1 type: ESTIMATED name: Analysis of biological sample measure: Incidence rate of major VPDs (vaccine-preventable infectious diseases): pertussis, influenza virus, respiratory syncytial virus, S.pneumoniae, N.meningitidis, H.influenzae. measure: Frequency of principal serotype, serogroups of pathogens causative for VPDs. measure: Number of meeting to diffuse the NETVAC results in Tuscany network. sex: ALL minimumAge: 1 Day maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Ospedale San Donato status: RECRUITING city: Arezzo country: Italy name: Marco Martini role: CONTACT email: marco.martini@uslsudest.toscana.it lat: 43.46276 lon: 11.88068 facility: Immunology Laboratory Meyer Children's Hospital, IRCCS status: RECRUITING city: Florence country: Italy name: Chiara Azzari role: CONTACT phone: +390555662542 email: chiara.azzari@unifi.it name: Silvia Ricci role: SUB_INVESTIGATOR lat: 43.77925 lon: 11.24626 facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence country: Italy name: Massimo Resti role: CONTACT email: massimo.resti@meyer.it lat: 43.77925 lon: 11.24626 facility: UO Pediatria Universitaria Ospedale S.Chiara status: RECRUITING city: Pisa country: Italy name: Diego peroni role: CONTACT email: diego.peroni@unipi.it lat: 43.70853 lon: 10.4036 hasResults: False

 nctId: NCT06322264 id: 2023-05435-01 briefTitle: Promoting Children's Participation in Conventional X-ray Examinations overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-12-14 date: 2025-04-04 date: 2024-03-21 date: 2024-04-26 name: Lund University class: OTHER name: Skane University Hospital briefSummary: The goal of this explorative observational study is to map the procedure and child centered approach in the examination for children that undergo conventional X-ray examinations. The main questions aim to answer:

* How many images need to be retaken during conventional X-ray examinations?
* What is the reason why the pictures need to be redone?
* What is the time required for the various examinations?
* What experience of the procedure of the examination is there among those involved?
* Can the physical impact be observed through variation in heart rate in children that undergo conventional X-ray examinations?

Participants will answer questionnaires about the children's participation in the procedure and the variation in heart rate will be measured on the children who undergo the examinations. conditions: Heart Rate Determination conditions: Patient Participation studyType: OBSERVATIONAL observationalModel: FAMILY_BASED timePerspective: CROSS_SECTIONAL count: 220 type: ESTIMATED name: Measurement of variation in heart rate measure: Variation in heart rate sex: ALL minimumAge: 4 Years maximumAge: 12 Years stdAges: CHILD hasResults: False

 nctId: NCT06322251 id: 2023-03399-01 briefTitle: Identification of Interpesonal Violence acronym: ViP overallStatus: RECRUITING date: 2024-04-01 date: 2027-06-30 date: 2028-06-30 date: 2024-03-21 date: 2024-04-29 name: Region Stockholm class: OTHER_GOV name: Linkoeping University name: Karolinska Institutet name: Stockholm University briefSummary: The goal of this study is to increase primary care professional's ability to identify individuals exposed to intimate partner violence (IPV) in primary health care settings.

The main questions it aims to answer are

1. To what extent do the following three interventions contribute to identify potential victims of IPV: (1) the use of a standardized questionnaire that screens exposure to IPV, (2) staff using tailored virtual patients for clinical training on IPV and (3) a combination of interventions 1 and 2?
2. Which intervention do primary care professionals experience as most effective in increasing the ability to identify and respond to victims of IPV?

Participants will be divided to apply one of the three interventions in their health care setting: 1) a standardized questionnaire to patients, 2) virtual patients tailored to health professionals, and 3) a combination of 1 and 2.

Pre-and post-measurement of the health professionals identification of patients exposed to IPV will will be used to explore the effect of the interventions.

Focus group interviews with the participating health professionals will be a qualitative complement. The participants will be asked about what intervention they experience as the most effective in increasing the ability to identify victims of IPV. conditions: Primary Health Care conditions: Interpersonal Violence conditions: Youth conditions: Pregnancy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Baseline measure - Number of patients that are identified fo being exposed to violence.

Intervention:

There are three settings:

1. Primary Care Health Centers
2. Youth Clinics
3. Maternity Clinics

At each type of clinic, the following interventions will be applied:

Identification of domestic violence through

1. Use of Virtual patient
2. use of screening questionnaire
3. a combination of a and b above.

The clinics will randomised to either condition a, b or c. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 200 type: ESTIMATED name: Use of instrument to identify exposure to violence in close relationships measure: Number of identified persons seeking healthcare who have been exposed to violence measure: Number of identified persons seeking healthcae who have been exposed to violence measure: Experiences of health care staff sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Linköping University status: RECRUITING city: Linköping zip: 581 83 country: Sweden name: Mia Barimani, Professor role: CONTACT phone: +46737083163 email: mia.barimani@liu.se name: Wibke Jonas, Ass prof role: CONTACT phone: +46707482518 email: wibke.jonas@ki.se lat: 58.41086 lon: 15.62157 hasResults: False

 nctId: NCT06322238 id: 23-008706 briefTitle: Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice: acronym: PREPARE-Mayo overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-03-21 date: 2024-03-21 name: Mayo Clinic class: OTHER briefSummary: The purpose of this study is to determine whether the implementation of pre-emptive pharmacogenomic (PGx) testing of a panel of clinically relevant PGx markers, to guide the dose and drug selection for 39 commonly prescribed drugs, will result in an overall reduction in the number of clinically relevant drug-genotype associated ADRs which are causally related to the initial drug of inclusion (referred to as 'index drug'). conditions: Pharmacogenomic Drug Interaction conditions: Side Effect of Drug conditions: Ineffective Drug Action conditions: Drug Metabolism, Poor, CYP2D6-Related conditions: Drug Metabolism, Poor, CYP2C19-Related studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 66 type: ESTIMATED name: PGx panel test measure: Adverse Drug Reaction (ADR) measure: PREPARE-MAYO Clinicians' and pharmacists' Questionnaire. measure: Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic city: Rochester state: Minnesota zip: 55902 country: United States name: Elisa Houwink, MD, PhD role: CONTACT phone: 507-319-2037 email: houwink.elisa@mayo.edu name: Mary Johnson role: CONTACT email: johnson.mary15@mayo.edu name: Jessica Wright, PharmD role: SUB_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06322225 id: 2023YFC2507401 briefTitle: Establishment of Big Data Platform and Biobank for Colorectal Tubular Adenoma Lesions overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-21 date: 2024-03-21 name: Sixth Affiliated Hospital, Sun Yat-sen University class: OTHER name: National Key Research and Development Program of China briefSummary: Colorectal tubular adenoma is the most common precancerous lesion of colorectal cancer, and the point is that its precise prevention and treatment can reduce the incidence of colorectal cancer.However, the epidemiological characteristics of colorectal tubular adenoma in China are unclear, the rate of missed diagnosis by colonoscopy is high, and the existing diagnosis and treatment techniques are lack of unified quality control standards,which makes it difficult to diagnose and achieve accurate prevention and control. How to improve the precise prevention and treatment of colorectal tubular adenoma and reduce the incidence of colorectal cancer is a major clinical scientific problem that needs to be solved urgently. For this purpose, this study was conducted in colorectal guided by the needs of accurate prevention and treatment of tubular adenoma lesions,and a multi-center colorectal tubular adenoma data management platform and a high-risk population database covering a full range of data including demographic characteristics, lifestyle factors, clinical information, endoscopic data and pathological images were established, biological sample databases of patients with pathological changes and high-risk populations were established, and data quality control and sample quality control standards were formulated standards-based.

The pathological prediction model and accurate risk assessment system of colorectal tubular adenoma were constructed by the pathological database. conditions: Colorectal Tubular Adenoma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 30000 type: ESTIMATED measure: Clinical information such as demographic characteristics, clinical data, endoscopy and pathological images sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06322212 id: 23-001083 briefTitle: Type 2 Diabetes and Blood Brain Barrier Improvement overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2026-04 date: 2024-03-20 date: 2024-03-20 name: University of California, Los Angeles class: OTHER briefSummary: The majority of T2DM adults show thiamine (vitamin B1) deficiency which may contribute to impaired function. This study will examine patients with T2DM through brain MRI scans, cognition assessments, blood tests, and questionnaires. Our goal is to see if a thiamine treatment (taking vitamin B1 capsules) can improve function. Patients will be asked to come to UCLA two times three months apart and each visit will last about 2.5-3 hours. conditions: Type2diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Compare BBB function, cognition, and mood in T2DM adults with and without Thiamine treatment. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants will be assigned a number to be used instead of their names with double-blind randomization until visits are complete and data is analyzed. whoMasked: PARTICIPANT count: 52 type: ESTIMATED name: Thiamine name: Placebo measure: Assess if BBB function has been repaired. measure: Analyze blood serum S100β levels. measure: Examine cognition in T2DM adults with thiamine treatment. measure: Cognition assessment in T2DM adults after thiamine treatment. measure: Examine depression in T2DM adults with thiamine treatment. measure: Assess anxiety in T2DM adults with thiamine treatment. sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCLA city: Los Angeles state: California zip: 90095 country: United States lat: 34.05223 lon: -118.24368 typeAbbrev: Prot_ICF hasProtocol: True hasSap: False hasIcf: True label: Study Protocol and Informed Consent Form date: 2023-11-17 uploadDate: 2024-03-07T13:21 filename: Prot_ICF_000.pdf size: 309752 hasResults: False

 nctId: NCT06322199 id: 2021-02504 (Project 3) briefTitle: Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy Attempted Suicide Short Intervention Program (ASSIP) on Neuropsychological Correlates and Psychological Process Factors - Project 3 acronym: NePsyAssip HT overallStatus: RECRUITING date: 2022-09-23 date: 2024-12-31 date: 2024-12-31 date: 2024-03-20 date: 2024-03-20 name: University of Bern class: OTHER briefSummary: The present study consists of 3 projects in total. It aims to investigate the (neuro-) psychological patterns from suicidal ideation to suicidal behavior as well as the feasibility and cost-effectiveness of ASSIP flex.

The overall aim of Project 3 is to evaluate the feasibility and cost-effectiveness of ASSIP flex over a 12-month follow-up period in terms of suicide reattempts and suicide correlates in a cohort who is attending ASSIP flex after a suicide attempt. conditions: Suicide, Attempted conditions: Suicidal Ideation conditions: Feasibility conditions: Cost-effectiveness conditions: Process Factors studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: ASSIP (Attempted Suicide Short Intervention Program) flex measure: Suicidal ideation (Baseline, t0) measure: Suicidal ideation and suicidal behavior (Baseline, t0) measure: Suicidal ideation (Follow-up, t1) measure: Suicidal ideation and suicidal behavior (Follow-up, t1) measure: Suicidal ideation (Follow-up, t2) measure: Suicidal ideation and suicidal behavior (Follow-up, t2) measure: Treatment costs of treatments 1 measure: Sociodemographic data measure: Depressive symptoms measure: General sense of self-efficacy measure: Self-Management measure: Health Literacy measure: Loneliness measure: Therapeutic Alliance measure: Adherence and Competence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier universitaire vaudois (CHUV) status: RECRUITING city: Lausanne country: Switzerland lat: 46.516 lon: 6.63282 facility: Center Neuchâtelois de Psychiatrie status: RECRUITING city: Neuchâtel country: Switzerland lat: 46.99179 lon: 6.931 facility: Psychiatric Hospital, University of Zurich (PUKZH) status: RECRUITING city: Zürich country: Switzerland lat: 47.36667 lon: 8.54999 facility: Sanatorium Kilchberg status: RECRUITING city: Zürich country: Switzerland lat: 47.36667 lon: 8.54999 hasResults: False

 nctId: NCT06322186 id: STAYWARM-2 Trial briefTitle: Study to Actively Warm Trauma Patients-2 acronym: STAYWARM-2 overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-03 date: 2024-03-20 date: 2024-03-20 name: Sunnybrook Health Sciences Centre class: OTHER briefSummary: Massively bleeding trauma patients have higher odds of mortality, increased hospital length of stay, and increased need for transfusion if they become hypothermic. Hypothermia is independently associated with mortality in traumatically injured patients due to its negative physiologic effects on hemostasis, cardiorespiratory and renal function.

Current warming strategies increase the logistical difficulty of transferring patients (which is frequent during the initial hours of trauma care) or must be changed at frequent intervals. Prehospital, military, and intraoperative studies have suggested chemical warming blankets as a pragmatic strategy to manage hypothermia. A recent pilot study (manuscript under review) at our institution demonstrated the feasibility of using the Ready-Heat® (TechTrade LLC, Orlando, FL, USA) chemical heating blanket in the initial phases of hospital care in bleeding trauma patients requiring a mass hemorrhage protocol (MHP). These self-warming blankets provide warmth over 8 hours at up to 40 degrees Celsius, carrying the advantage of portability with no continuous electric power requirement. Furthermore, the Ready-Heat blanket may be more effective than current strategies for rewarming patients at high risk of developing hypothermia. STAYWARM-2 will be the first randomized controlled trial performed in-hospital to evaluate a self-warming blanket to address hypothermia in massively bleeding trauma patients within the initial hours of hospital arrival.

This study will help to determine the efficacy and feasibility of using chemical heating blankets for hypothermia in the early hours of hospital care. This has potential to reduce the overall workload of direct care clinicians, freeing them for other patient care duties. Additionally, the intervention may achieve enhanced thermoregulation compared to current strategies, improving patient care and comfort, and avoiding the clinical complications related to hypothermia. Findings from this preliminary study may provide data for a future grant to launch a larger randomized controlled trial in the prehospital/in-hospital trauma setting to optimize the care of patients at risk of developing hypothermia. conditions: Trauma Injury conditions: Hypothermia conditions: Massive Hemorrhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Eligible patients will be randomized 1:1 to receive either the experimental or control arm.

Experimental arm: 2 Ready-Heat 4-panel blankets Control arm: standard of care (use of warmed blankets and forced air warmed blanket \[FAWB\]) primaryPurpose: OTHER masking: SINGLE maskingDescription: Only the statistician will remain blinded during the final analysis. whoMasked: OUTCOMES_ASSESSOR count: 74 type: ESTIMATED name: Ready-Heat Chemical Heating Blankets name: Warmed blankets or FAWB measure: An increase of 1⁰C at eight hours from the time of blanket placement measure: Adherence to the 2 blankets application in the trauma bay in at least 80% of patients. measure: Adherence to body temperature measurements (in degrees Celsius) 80% of each of the phases of initial care up to 8 hours following admission. measure: Adherence to maintain the blankets applied on the patient in 80% of each of the phases of initial care up to 8 hours following admission. measure: Concurrent warming strategies measure: Blood product usage measure: Coagulation parameter 1: platelet count measure: Coagulation parameter 2: INR measure: Coagulation parameter 3: fibrinogen measure: Perfusion parameter 1: pH measure: Perfusion parameter 2: base deficit measure: Perfusion parameter 3: serum lactate measure: Hemoglobin level measure: Blanket placed directly on skin measure: Skin redness and/or burns sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-08-21 uploadDate: 2024-02-21T15:24 filename: Prot_SAP_000.pdf size: 1303584 hasResults: False

 nctId: NCT06322173 id: 2022-13 briefTitle: Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Advanced NGS Sequencing Methods acronym: ARES_NGS overallStatus: RECRUITING date: 2022-06-28 date: 2024-12 date: 2024-12 date: 2024-03-20 date: 2024-03-20 name: IRCCS Sacro Cuore Don Calabria di Negrar class: OTHER briefSummary: This is an experimental study without drug and device, non-profit, on biological samples stored at the Tropica Biobank of the DITM. The aim of the project is to verify the performance of NGS-based assays, which can be used in the field of microbiology. The clinical evaluation investigations of NGS technology will be conducted on an adequate number of clinical blood samples and rectal swabs. The analyzes will be compared with the standard microbiology methods used in the DITM diagnostic routine. conditions: Resistance Bacterial studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: NGS Analysis measure: Microorganism presence (positive/negative) measure: Microorganism identification measure: Identification of Gene mutations that convey resistance to antibiotics (resistant/susceptible) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Sacro Cuore Don Calabria hospital status: RECRUITING city: Negrar state: Verona zip: 37024 country: Italy name: Elena Pomari role: CONTACT phone: +390456013111 email: elena.pomari@sacrocuore.it name: Elena Pomari role: PRINCIPAL_INVESTIGATOR name: Pierantonio Orza role: SUB_INVESTIGATOR name: Francesca Perandin role: SUB_INVESTIGATOR lat: 45.52918 lon: 10.93899 hasResults: False

 nctId: NCT06322160 id: 5714 briefTitle: The Role of tHyroid cAncer Specific Patient Concerns iNventory (PCI-TC) in Enhancing Shared decisiOn Making acronym: HANSOM overallStatus: RECRUITING date: 2023-05-03 date: 2024-12-31 date: 2024-12-31 date: 2024-03-20 date: 2024-03-20 name: Royal Marsden NHS Foundation Trust class: OTHER name: ENTUK briefSummary: Multiple clinical equipoises exist for the management of thyroid cancers. Shared decision-making (SDM) process where patients are supported to consider options, to achieve informed preferences with their clinicians have been recommended to improve patients' satisfaction and their overall quality of life. However, SDM can be difficult to achieve in our standard clinical encounters due to clinician's lack of confidence and time limitation to elicit patient's concerns and preferences. PCI as a decision-making support tool has shown to enhances clinician's awareness of patient's needs and allows for a more effective communication while the consultation time is unaffected. The successful development, testing and implementation of a PCI-TC could improve patient satisfaction, clinical efficiency and ensure that unmet need is appropriately addressed. This study will support the development of PCI-TC to better understand the wide-ranging needs of our patients and to improve the SDM process in the thyroid cancer management pathway. conditions: Thyroid Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 32 type: ESTIMATED name: Interview measure: To explore patients' and clinicians' view and experience of the current decision-making process for low risk differentiated thyroid cancer measure: • To explore clinicians' and patients' user experience of thyroid cancer specific patient concerns inventory (PCI-TC) in thyroid cancer outpatient clinics. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guys & St Thomas status: RECRUITING city: London country: United Kingdom name: Aleix Mr Rovira, PhD role: CONTACT lat: 51.50853 lon: -0.12574 facility: UCLH status: RECRUITING city: London country: United Kingdom name: Francis Mr Vaz, FRCS role: CONTACT lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06322147 id: KYLL-202304-31 briefTitle: Chemotherapy With Cetuximab as Conversion Therapy in RAS/BRAF WT Unresectable Liver Metastasis Right-sided Colon Cancer overallStatus: RECRUITING date: 2023-06-01 date: 2024-12-30 date: 2025-12-30 date: 2024-03-20 date: 2024-03-20 name: Qilu Hospital of Shandong University class: OTHER briefSummary: This study was designed as multi-center, ambispective observational trial to evaluate the efficacy and safety of addition of cetuximab to doublet or triplet chemotherapy as conversion therapy in right-sided BRAF/RAS wild-type CRLM with curative intent. The primary endpoint was radical resection rate (R0). The secondary endpoint was response rate, rate of NED, depth of remission, early tumor shrinkage, progression free survival and safety. conditions: Colon Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 50 type: ESTIMATED name: Doublet or triplet chemotherapy combined with cetuximab measure: R0 resection rate measure: Objective response rate measure: Reported adverse events measure: Progression free survival measure: no evidence of disease measure: depth of response measure: Early Tumor Shrinkage sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Qilu hospital of Shandong University status: RECRUITING city: Jinan state: Shandong zip: 250012 country: China name: xiangling Wang, Dr. role: CONTACT phone: 8653182169841 email: xlwang71@163.com name: Jing Hao role: PRINCIPAL_INVESTIGATOR lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06322134 id: DROWN_SAR briefTitle: Drowning Incidents Treated by the Danish SAR Helicopters acronym: DROWN_SAR overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-20 date: 2024-03-25 name: Prehospital Center, Region Zealand class: OTHER briefSummary: Improving oxygenation and ventilation in drowning patients early in the field is critical and may be lifesaving. This may be achieved by helicopter emergency medical services (HEMS) such as the Danish Air Ambulance, or the Royal Danish Air Force's Search And Rescue (SAR) helicopters. The SAR operates in all weather conditions and is equipped with a hoist system, able to hoist patients from the sea or small ships without helipads. This study aimed to estimate the incidence of drowning missions attended by the Royal Danish Air Force's SAR helicopter and describe patient characteristics and prehospital interventions. conditions: Drowning conditions: Drown conditions: Drowning; Anoxia conditions: Drowning, Near conditions: Drowning and Nonfatal Submersion conditions: Drowning or Immersion of Unknown Intent conditions: Drowning and Submersion, Undetermined Intent conditions: Drowning and Submersion While in Natural Water conditions: Drowning and Submersion Due to Sailboat Sinking conditions: Drowning and Submersion Due to Fall Off Ship studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 120 type: ESTIMATED name: Drowning incident measure: Annual incidence of drowning treated by the Danish SAR helicopters from 2014-2023 measure: Annual incidence rate of drowning treated by the Danish SAR helicopters from 2014-2023 measure: Spatial distribution of drowning patients treated by the Danish SAR helicopters from 2014-2023 measure: Drowning to water rescue ratio sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Prehospital Center city: Næstved state: Region Zealand zip: 4700 country: Denmark lat: 55.22992 lon: 11.76092 hasResults: False

 nctId: NCT06322121 id: NL83653.058.23 briefTitle: Vascular Aspects in Dementia: Part 2 overallStatus: RECRUITING date: 2023-09-04 date: 2026-09 date: 2026-09 date: 2024-03-20 date: 2024-04-11 name: Leiden University Medical Center class: OTHER briefSummary: Cerebral amyloid angiopathy (CAA), a common cerebrovascular small vessel disease (SVD), is a frequently (98%) found co-morbidity at autopsy in patients with Alzheimer's disease (AD). Current in vivo hallmarks of CAA represent changes relatively late in the disease process and leaves CAA in AD often undetected. Recently, it was shown that decreased vascular reactivity (VR) measured with blood oxygen level dependent (BOLD) MRI, after visual stimulus, is an early CAA marker. With BOLD-MRI to detect decreased VR in different stages of AD, it was shown that increasing stages of AD associate with decreasing VR independent of age, classic SVD markers and atrophy. Moreover, VR is associated with cognitive deficits. Therefore, cross-sectional data indicate that decreased VR is an important co-morbidity already in early stages of AD with an independent effect on disease severity. In this respect, the study aim is to determine the natural course of the decrease of VR in both controls and (early stage) AD patients to monitor AD disease progression. This is an essential step to aid in the development and application of effective treatment as it is expected that CAA can cause/worsen AD pathology. conditions: Dementia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: MRI measure: Vascular reactivity - BOLD amplitude measure: Vascular reactivity - time-to-peak measure: Vascular reactivity - time-to-baseline measure: Intracranial hemorrhage measure: Lobar microbleeds measure: Subarachnoidal hemorrhage measure: Superficial siderosis measure: Lacunes measure: Volume of white matter hyperintensities (WMHs) measure: Perivascular spaces in the basal ganglia measure: Perivascular spaces in the centrum semiovale measure: Gray matter volume sex: ALL minimumAge: 50 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Leids Universitair Medisch Centrum status: RECRUITING city: Leiden zip: 2333 ZA country: Netherlands name: Suzanne E van Dijk, drs role: CONTACT email: S.E.van_Dijk.RADI@lumc.nl lat: 52.15833 lon: 4.49306 hasResults: False

 nctId: NCT06322108 id: IMMONC0008 briefTitle: Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2030-04 date: 2030-04 date: 2024-03-20 date: 2024-03-20 name: Immune Oncology Research Institute class: OTHER name: Agenus Inc. briefSummary: The goal of this study is to see if the combination of immunotherapy agents botensilimab and balstilimab is safe and effective in participants with metastatic non-small cell lung cancer (NSCLC) as a first-line treatment. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Botensilimab + Balstilimab measure: 12-Month Progression-Free Survival (PFS) measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Duration of Response (DOR) measure: Time to Next Treatment (TTNT) measure: Overall Survival (OS) Time measure: Frequency, severity, and duration of treatment emergent adverse events (TEAEs) (Safety and tolerability) measure: Health-related quality of life (HRQoL) according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) measure: Health-related quality of life according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC29) measure: Health-related quality of life according to the 5 Level EuroQol 5 Dimension (EQ-5D-5L) questionnaire measure: Correlation between baseline expression of PD-L1 by immunohistochemistry (IHC) and 12-month progression-free survival measure: Correlation between baseline expression of PD-L1 by immunohistochemistry (IHC) and objective response rate measure: Correlation between existence of liver metastases on imaging at baseline and 12-month progression-free survival measure: Correlation between existence of liver metastases on imaging at baseline and objective response rate measure: Level of circulating tumor DNA (ctDNA) at baseline and at different time points after start of treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hematology Center named after prof. R. Yeolyan city: Yerevan zip: 0014 country: Armenia name: Samvel Bardakhchyan, MD, PhD role: CONTACT phone: +374 (010) 283800 email: samvelbardakhchyan@gmail.com name: Amalya Sargsyan, MD role: CONTACT phone: +374 (010) 283800 email: amalyasargsyan@gmail.com lat: 40.18111 lon: 44.51361 hasResults: False

 nctId: NCT06322095 id: GH21C202 briefTitle: A Study of GH21 Combined With Previous Target Therapy or Immunotherapy in Patients With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-03-22 date: 2025-09-30 date: 2025-12-31 date: 2024-03-20 date: 2024-03-20 name: Suzhou Genhouse Bio Co., Ltd. class: OTHER briefSummary: This study is aim to evaluate the preliminary efficacy of GH21 combined with previous target therapy or immunotherapy in patients with advanced solid tumors. conditions: Patient With Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 72 type: ESTIMATED name: GH21+ Previous Target Therapy or Immunotherapy measure: Objective response rate (ORR) measure: Number of participants with adverse events measure: Duration of response (DOR) measure: Duration of response (DCR) measure: Progression-free survival (PFS) measure: Plasma concentration (Cmax) measure: Time to achieve Cmax (Tmax) measure: Area under the plasma concentration-time curve (AUC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital Chinese Academy of Medical Science city: Beijing state: Beijing zip: 100029 country: China name: Ning Li, Doctorate role: CONTACT phone: +86-10-87788495 email: lining@cicams.ac.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06322082 id: 1422024 briefTitle: Pilates Training and Low Intensity Shock Wave Therapy for Post-prostatectomy Stress Incontinence acronym: Incontinence overallStatus: ENROLLING_BY_INVITATION date: 2024-03-20 date: 2024-10-30 date: 2024-12-15 date: 2024-03-20 date: 2024-03-28 name: Khadra Mohamed Ali class: OTHER name: Cairo University briefSummary: 120 Patients with urinary incontinence following radical prostatectomy would be randomly assigned to either 4 groups all receive conventional pelvic floor muscle exercises plus group A receive Pilates exercises and Low Intensity Extracorporeal Shock Wave Therapy, group B receive Low Intensity Extracorporeal Shock Wave Therapy, group C receive Pilates exercises and group D receive conventional pelvic floor muscle exercises. Assessment at baseline, immediately after the intervention, to evaluate the degree of urinary incontinence and quality of life after three months from treatment. conditions: Stress Incontinence, Male studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG) measure: Cystometry measure: Severity index scale measure: body mass index sex: MALE minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: faculty of physical therapy , Cairo university city: Giza country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06322069 id: 202206260077 briefTitle: The Effect and Mechanism of Self-compassion on Reducing Materialism overallStatus: COMPLETED date: 2020-12-14 date: 2021-03-03 date: 2021-03-15 date: 2024-03-20 date: 2024-03-20 name: Beijing Normal University class: OTHER briefSummary: The current study provided an initial investigation of the effect of self-compassion on reducing materialism and explored the basic psychological needs and self-esteem as potential mechanisms. Two studies would be conducted. Study 1 explored the relationships among variables with cross-sectional data, to explore the relationship between self-compassion and materialism, and test the mediating role of basic psychological needs and self-esteem. Study 2 developed a new online self-help self-compassion intervention and conducted a randomized control trial (i.e., intervention group and waitlist group) to further explore the casual effect of self-compassion on materialism, with the mediating effect of basic psychological needs and self-esteem. conditions: Self-Compassion conditions: Group B studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In study 2, we conducted a randomized control trial, and there are two groups: self-compassion intervention group and waitlist group. primaryPurpose: OTHER masking: NONE count: 309 type: ACTUAL name: Self-compassion intervention group measure: Self-compassion measure: Self-Esteem measure: Basic Psychological Needs measure: Materialism sex: ALL minimumAge: 18 Years maximumAge: 63 Years stdAges: ADULT facility: Xianglong Zeng city: Beijing state: Beijing zip: 100875 country: China lat: 39.9075 lon: 116.39723 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-12 uploadDate: 2024-03-12T23:23 filename: Prot_SAP_000.pdf size: 110133 hasResults: False

 nctId: NCT06322056 id: 4-2023-1654 briefTitle: Exploring Approaches With Lower Targets of Blood Pressure and Lipid for Improving Renal Outcome in Advanced Chronic Kidney Disease acronym: EXCELSIOR-CKD overallStatus: NOT_YET_RECRUITING date: 2024-05-13 date: 2029-05-31 date: 2029-08-31 date: 2024-03-20 date: 2024-03-20 name: Yonsei University class: OTHER briefSummary: The purpose of this study is to prevent kidney disease progression in adults with advanced chronic kidney disease (estimated glomerular filtration rate \[eGFR\] between 15-45 mL/min/1.73 m2) using intensive blood pressure control and intensive lipid management with 2X2 factorial design. conditions: Chronic Kidney Diseases conditions: Hypertension conditions: Dyslipidemias studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 642 type: ESTIMATED name: Intensive control of SBP and intensive control of LDL-C name: Intensive control of SBP and standard control of LDL-C name: Standard control of SBP and intensive control of LDL-C name: Standard control of SBP and standard control of LDL-C measure: Renal composite outcome measure: Individual components of renal composite outcome measure: eGFR slopes measure: Cardiovascular composite outcome sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Severance Hospital city: Seoul zip: 03722 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06322043 id: VM-APFB-1023 briefTitle: Evaluation of Safety of Filler Injection in Subcutaneous Tissues overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2025-04 date: 2024-03-20 date: 2024-03-20 name: Volumina Medical S.A. class: INDUSTRY briefSummary: Adipearl is an injectable filler intended to be injected subcutaneously. conditions: Volume Deficiency studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 18 type: ESTIMATED name: Adipearl measure: Safety of Investigational Medical Device sex: ALL minimumAge: 22 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Summit Clinic city: Crans-Montana country: Switzerland name: Summit Clinic role: CONTACT lat: 46.31316 lon: 7.47914 hasResults: False

 nctId: NCT06322030 id: N4281-R id: RX004281 type: OTHER_GRANT domain: VA ORD RR&D id: PRO0120848 type: OTHER domain: IRB Approval briefTitle: Weight Loss and ExeRcise acronym: EMPOWER overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-12-31 date: 2028-03-31 date: 2024-03-20 date: 2024-04-25 name: VA Office of Research and Development class: FED briefSummary: Weight loss interventions for neurologically health individuals have established benefits for improving physical and psychosocial function. The investigators believe that Veterans who have had a stroke would realize similar benefits and that the effects would be enhanced with concurrent exercise training. The investigators will study the effects of a 15-week lifestyle management program to determine if it can effectively improve some of the physical and psychosocial problems common in Veterans who have had a stroke. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The investigators will utilize a 2x2 factorial design to assess for changes in our outcomes over time between treatment groups. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The coordinator will not see group assignment, only a patient number which is entered into a software package. whoMasked: OUTCOMES_ASSESSOR count: 99 type: ESTIMATED name: FOCUS-15 Lifestyle Management Program name: Exercise Training measure: Change in distance walk in 6 minute Walk Test measure: Change in daily step activity measure: Change in score of Stroke Impact Scale (SIS) measure: Change in score of Sheehan Disability Scale (SDS) measure: Change in score of Inventory of Psychosocial Functioning (IPF) measure: Change in blood lipid profile measure: Change in body composition in Dual-energy x-ray absorptiometry sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ralph H. Johnson VA Medical Center, Charleston, SC city: Charleston state: South Carolina zip: 29401-5703 country: United States name: R. Amanda C LaRue, PhD role: CONTACT phone: 843-789-6707 email: Rutha.Larue@va.gov name: Thad Abrams, MD role: CONTACT phone: (319) 338-0581 phoneExt: 7618 email: thad.abrams@va.gov name: Chris M Gregory, PhD role: PRINCIPAL_INVESTIGATOR lat: 32.77657 lon: -79.93092 hasResults: False

 nctId: NCT06322017 id: RC22_0450 briefTitle: Prospective Multicenter Randomized and Controlled Study Evaluating the Benefit of Early Pulmonary Vein Isolation Compared to Usual Treatment in Patients Aged Over 75 Years and Presenting With Atrial Fibrillation acronym: EDearly AF overallStatus: RECRUITING date: 2024-04-09 date: 2028-04-09 date: 2028-04-09 date: 2024-03-20 date: 2024-04-11 name: Nantes University Hospital class: OTHER briefSummary: Therapeutic management of Atrial Fibrillation (AF) is based either on heart rate control or on rhythm control, a strategy which aims to maintain a normal heart rhythm. The benefit in terms of morbidity and mortality of a normal heart rhythm would, however, be largely offset by the frequent side effects of antiarrhythmic drugs which could even lead to an increase in mortality compared to rate control. This increase has particularly been suggested in people aged over 75.

Since the emergence of catheter Pulmonary Vein Isolation (PVI), an effective alternative to antiarrhythmic drugs has become available. This technique makes it possible to isolate the foci triggering AF under local or general anesthesia with greater effectiveness than medications and very low risks. Records in the elderly do not seem to show a reduction in effectiveness or an increase in complications. However, in the absence of a dedicated randomized study, its use is strongly limited in the elderly where rate control (52% of people over 65 years old) and the use of antiarrhythmic drugs are largely favored due to the simplicity of implementation and the low cost of medications.

However, an early rhythm control strategy seems to reduce cardiovascular events in relatively old individuals (average age 70 years). The use of PVI in first line could make it possible to further improve these results.

The objective of the investigator is therefore to carry out the first randomized comparative study proposing to evaluate the impact of early PVI compared to usual treatment in patients aged 75 and over with AF. conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 294 type: ESTIMATED name: Rhythm control by Pulmonary Vein Isolation (PVI) procedure name: Conventional care by antiarrhythmic drugs (flecainide, sotalol, amiodarone) or bradycardic drugs (all betablocker or calcium channel blocker therapy, digoxin) measure: Time before occurrence of the first event among cardiovascular death, hospitalization (all causes) and stroke measure: Number of PVI peri-procedural complications measure: Number of complications measure: Quality of life score measure: Quality of life score measure: Quality of life score measure: Quality of life score measure: Quality of life score measure: Quality of life score measure: Number of documented episodes of AF measure: Number of patients treated by cardiovascular drugs measure: Doses of cardiovascular drugs measure: Autonomy score measure: Autonomy score measure: Autonomy score measure: Autonomy score measure: Autonomy score measure: Autonomy score measure: Autonomy score measure: Autonomy score measure: Autonomy score measure: Autonomy score measure: Autonomy score measure: Autonomy score measure: Body weight measure: Body weight measure: Body weight measure: Body weight measure: Body weight measure: Body weight measure: Numbers of falls measure: Numbers of falls measure: Numbers of falls measure: Numbers of falls measure: Numbers of falls measure: Numbers of falls measure: Physical performance score measure: Physical performance score measure: Evolution of ADL score according to the results of the Integrated Care for Older People (ICOPE) test at inclusion measure: Evolution of IADL score according to the results of the ICOPE test at inclusion measure: Cognitive assessment measure: Cognitive assessment measure: Cognitive assessment measure: Cognitive assessment measure: Cognitive assessment measure: Cognitive assessment sex: ALL minimumAge: 75 Years stdAges: OLDER_ADULT facility: Nantes University Hospital status: RECRUITING city: Nantes state: Loire Atlantique zip: 44093 country: France name: Jean-Baptiste GOURRAUD, MD role: CONTACT phone: 0240165143 email: JeanBaptiste.GOURRAUD@chu-nantes.fr lat: 47.21725 lon: -1.55336 hasResults: False

 nctId: NCT06322004 id: 1718/2022 briefTitle: Video-Interpreting in Prehospital Emergency Medicine - Feasibility Study overallStatus: RECRUITING date: 2023-02-06 date: 2025-02-05 date: 2025-11-01 date: 2024-03-20 date: 2024-03-20 name: Medical University of Vienna class: OTHER briefSummary: 50 responsive patients with language barriers will be included in this study. The prehospital emergency physician will start video-interpreting via a tablet. Feasibility, quality of communication, usability as well as changes in diagnosis and treatment will be gathered and analysed. conditions: Communication Barriers studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Technical Feasibility measure: Usability of video-interpreting measure: Impact on emergency physician's decisions measure: Demographic parameters sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Vienna status: RECRUITING city: Vienna zip: 1090 country: Austria name: Christina Hafner, DDr. role: CONTACT email: christina.hafner@meduniwien.ac.at name: Maike Fink, Dr.med.univ. role: SUB_INVESTIGATOR name: Christina Hafner, DDr. role: PRINCIPAL_INVESTIGATOR lat: 48.20849 lon: 16.37208 hasResults: False

 nctId: NCT06321991 id: S68382 briefTitle: Nodular Shrinking in Dupuytren Disease acronym: Echo overallStatus: RECRUITING date: 2024-02-15 date: 2026-03-01 date: 2026-03-01 date: 2024-03-20 date: 2024-03-22 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: Dupuytren disease (DD) is a common hand disorder with disabling finger contractures that may require surgery to restore function. In the early stages of the disease, the nodules (Tubiana stage 0) are usually painless, but a reason for concern to many patients. Not rarely, lifestyle measures and even risky treatment options as radiotherapy are advised, yet no therapy to prevent disease evolution has a solid proven effect. Furthermore, reliable non-invasive measurement of early stage DD is not validated.

Evidence was found that pharmacotherapy may influence DD evolution, but valuable clinical trials are limited. Case series and non-published explorative follow-up suggested local treatment with antioxidant vitamin E to possibly interfere with an evolution of DD nodules to contracting strands. This study aims to provide evidence on efficiency of this non-invasive treatment option.

Secure measurement of nodule evolution is a clinical challenge. To measure this evolution, ultrasound and MRI scanning are currently being performed. Stage 0 (nodules) is more challenging to quantify. A strict individual follow-up by the treating clinician is needed to standardize measurement of selected (treated) nodules. Therefore, simple ultrasound by the treating clinician may provide an good tool to collect data. This study aims to introduce and validate this non-invasive scan method and provide a prospective double blind investigation of a measurable effect of non-invasive preventive treatment for stage 0 DD to improve clinical outcome. conditions: Dupuytren's Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Simple random allocation will be ensured by the principal investigators' designated staff (study nurse of IORT), who will not be involved in recruiting trial participants, medical care, drug administration or follow-up, through the generation of a random numbers table with computer software program. A randomization list will be prepared by the Sponsor's designated staff, not involved in recruiting Trial participants, medical care, drug administration or follow-up. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: To avoid bias, treatment arms will be blinded to Investigators, Trial staff, participants,.. as follows: vitamin E creme will be packaged and labelled in such a way that the visual appearance, nor the smell and/or touch of the creme can be distinguished from placebo (Vaseline). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Vitamin E-creme (Remederm®) vs Vaseline (Placebo) name: Ultrasound measurement measure: Downsizing of the largest nodule diameter measure: VAS questionnaire on pain measure: VAS questionnaire on satisfaction measure: QUICK Dash for functionality measure: Abe Diathesis scoring measure: Range of motion measure: Recurrence rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Leuven status: RECRUITING city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium name: Ilse Degreef, Prof. Dr. role: CONTACT phone: +3216338843 email: ilse.degreef@uzleuven.be name: Anna Tarasiuk role: CONTACT phone: +3216338818 email: orthopedie.research@uzleuven.be lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06321978 id: MxBFlexUP ESP briefTitle: Mepilex Border Flex Utilization Pilot Spain acronym: MxBFlexUPESP overallStatus: RECRUITING date: 2024-02-16 date: 2024-05-31 date: 2024-05-31 date: 2024-03-20 date: 2024-03-20 name: Molnlycke Health Care AB class: INDUSTRY briefSummary: The aim of this study is to assess and describe the utilization of Mepilex® Border Flex and other foam dressings available in routine clinical practice in the management of patients with chronic wounds, in order to understand the pattern of use and the frequency of dressing changes in wound management. The study will also allow to gain information about the opinion of the HCPs and the patient's experience concerning wound management with foam dressings. This information may help to understand patient's health care optimization in terms of quality and efficiency. conditions: Wound studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 40 type: ESTIMATED name: Mepilex Border Flex measure: Dressing use measure: Wound characteristics measure: Wound management measure: HCP opinion measure: Patient Experience measure: Costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CS Ciudad Expo - Mairena de Aljarafe status: RECRUITING city: Sevilla state: Andalusia zip: 41927 country: Spain name: Andrés Roldán Valenzuela, Nurse role: CONTACT phone: +34609431073 email: andres.roldan.sspa@juntadeandalucia.es name: Andrés Roldán Valenzuela, Nurse role: PRINCIPAL_INVESTIGATOR lat: 37.38283 lon: -5.97317 hasResults: False

 nctId: NCT06321965 id: 69HCL22_0599 briefTitle: Characterization of New Phenotypes of Patients With Spinal Muscular Atrophy Treated With SMN Restoring Therapy acronym: PHENO SMART overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-10-01 date: 2027-10-01 date: 2024-03-20 date: 2024-03-20 name: Hospices Civils de Lyon class: OTHER briefSummary: With the advent of new treatments for ASI, new phenotypes are emerging. The investigators propose to describe these new phenotypes by prospectively following children with ASI of all types treated with TRS and aged under 16 for 2 years.

The investigators also propose to evaluate potential assessment tools to determine whether they are relevant for monitoring this population, either routinely or for future clinical trials. The investigators also aim to collect the total costs associated with ASI in order to propose a first prospective medico-economic study in France. conditions: Spinal Muscular Atrophy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, longitudinal, multicenter, international study primaryPurpose: OTHER masking: NONE count: 60 type: ESTIMATED name: evaluation of muscle function name: First-line cognitive assessment name: second-line cognitive assessment name: Cardiac evaluation name: MRI name: Assessment of activity and muscle fatigue name: Assessment of bulbar function name: Evaluation of body composition and metabolism name: Questionnaires name: Biocollection name: Skinfold measurement measure: Markers of disease progression and description of different phenotypes, at : muscular and functional measure: Markers of disease progression and description of different phenotypes, at : muscular and functional measure: Markers of disease progression and description of different phenotypes, at : muscular and functional measure: Markers of disease progression and description of different phenotypes, at : muscular and functional measure: Markers of disease progression and description of different phenotypes, at : muscular and functional measure: Markers of disease progression and description of different phenotypes, at : Fatigue measure: Markers of disease progression and description of different phenotypes, at : Fatigue measure: Markers of disease progression and description of different phenotypes, at : Fatigue measure: Markers of disease progression and description of different phenotypes, at Orthopaedic level measure: Markers of disease progression and description of different phenotypes, at Orthopaedic level measure: Markers of disease progression and description of different phenotypes, at Orthopaedic level measure: Markers of disease progression and description of different phenotypes, at the cognitive level: Vineland-II measure: Markers of disease progression and description of different phenotypes, at the cognitive level: Bayley-4 measure: Markers of disease progression and description of different phenotypes, at the cognitive level: BRIEF (Behavioral Rating Inventory of Executive Function) measure: Markers of disease progression and description of different phenotypes, at the cognitive level: Conners-3 measure: Markers of disease progression and description of different phenotypes, at the cognitive level: CELF-5 (Language and communication assessment battery) measure: Markers of disease progression and description of different phenotypes, at the cognitive level: EQ (Empathy quotient), AQ (Autism Quotient) measure: Markers of disease progression and description of different phenotypes, at the cognitive level: M-CHAT-R (Modified Checklist for Autism in Toddlers) measure: Markers of disease progression and description of different phenotypes, at the cognitive level: SRS-2 (Social Responsiveness Scale, Second Edition) measure: Markers of disease progression and description of different phenotypes, at the cognitive level: PVSE (Basic visuo-spatial perception) measure: Markers of disease progression and description of different phenotypes, at the brain level measure: Markers of disease progression and description of different phenotypes, at Cardiology level measure: Markers of disease progression and description of different phenotypes, at metabolic level : Anthropometric measurement trends measure: Markers of disease progression and description of different phenotypes, at metabolic level : measure: Markers of disease progression and description of different phenotypes, at metabolic level : fractures measure: Markers of disease progression and description of different phenotypes, at metabolic level : renal ultrasound measure: Markers of disease progression and description of different phenotypes, at metabolic level : Absorptiometry (DXA) measure: Markers of disease progression and description of different phenotypes, at metabolic level: Calorimetry measure: Markers of disease progression and description of different phenotypes, at metabolic level : Impedancemetry measure: Markers of disease progression and description of different phenotypes, at metabolic level : Fibroscan measure: Markers of disease progression and description of different phenotypes, at biological analysis measure: Markers of disease progression and description of different phenotypes, at In terms of quality of life and autonomy measure: Markers of disease progression and description of different phenotypes, at In terms of quality of life and autonomy measure: Markers of disease progression and description of different phenotypes, at respiratory level : Chest/head circumference ratio (PT/PC ratio) (up to 3 years) measure: Markers of disease progression and description of different phenotypes, at respiratory level : Chest/head circumference ratio (PT/PC ratio) measure: Markers of disease progression and description of different phenotypes, at respiratory level : O2 saturation and nocturnal TcPCO2 measure: Markers of disease progression and description of different phenotypes, at respiratory level: Respiratory function tests (≥ 6 years) measure: Markers of disease progression at respiratory level measure: Markers of disease progression and description of different phenotypes, at bulbar level (Evaluation of dysphagia and dysarthria): DDD-pNMD (Diagnostic list for Dysphagia and Dysarthria in pediatric NeuroMuscular Disorders) measure: Markers of disease progression and description of different phenotypes, at bulbar level (Evaluation of dysphagia and dysarthria): NdSSS (Neuromuscular Disease Swallowing Status Scale). measure: Markers of disease progression and description of different phenotypes, at the level of Characteristics at inclusion: age of patient measure: Markers of disease progression and description of different phenotypes, at the level of Characteristics at inclusion : patient gender measure: Markers of disease progression and description of different phenotypes, at the level of Characteristics at inclusion: SMA TYPE measure: Markers of disease progression and description of different phenotypes, at the level of Characteristics at inclusion: number of copy measure: Markers of disease progression and description of different phenotypes, at the level of Characteristics at inclusion: treatment sex: ALL minimumAge: 0 Years maximumAge: 16 Years stdAges: CHILD facility: Pediatric Rehabilitation Service - L'Escale Mother and Child Hospital city: Bron state: Rhone zip: 69500 country: France name: Laure LE GOFF, PI role: CONTACT phone: 04.72.12.95.04 phoneExt: +33 email: laure.le-goff@chu-lyon.fr name: Laure LE GOFF role: PRINCIPAL_INVESTIGATOR lat: 45.73333 lon: 4.91667 facility: CHRU of Brest city: Brest zip: 29609 country: France name: Juliette ROPARS, Dr role: CONTACT phone: 02.98.22.33.89 phoneExt: +33 email: Juliette.ropars@chu-brest.fr name: Juliette ROPARS, Dr role: PRINCIPAL_INVESTIGATOR lat: 48.3903 lon: -4.48628 facility: Pediatric Neurology and Resuscitation Raymond-Poincare Hospital city: Garche zip: 92380 country: France name: Susana QUIJANO-ROY, Pr role: CONTACT phone: 01.47.10.79.16 phoneExt: +33 email: Susana.quijano-roy@aphp.fr name: Susana QUIJANO-ROY, Pr role: PRINCIPAL_INVESTIGATOR lat: 49.39419 lon: 6.19818 facility: Pediatric Neurology Swynghedauw Hospital city: Lille zip: 59037 country: France name: Jean-Baptiste DAVION, Dr role: CONTACT phone: 03.20.44.58.31 phoneExt: +33 email: Jeanbaptiste.davion@chru-lille.fr name: Jean-Baptiste DAVION, Dr role: PRINCIPAL_INVESTIGATOR lat: 50.63297 lon: 3.05858 facility: Marseille University Hospital - Timone Hospital Department of Pediatric Neurology - Specialized Pediatrics and Child Medicine city: Marseille zip: 13005 country: France name: Brigitte CHABROL, Pr role: CONTACT phone: 04.91.38.68.08 phoneExt: +33 email: brigitte.chabrol@ap-hm.fr name: Brigitte CHABROL, Pr role: PRINCIPAL_INVESTIGATOR lat: 43.29551 lon: 5.38958 facility: I-Motion Pediatric Clinical Trial Platform Armand Trousseau Hospital city: Paris zip: 75012 country: France name: Andreea SEFERIAN, Dr role: CONTACT phone: 01.71.73.80.50 phoneExt: +33 email: a.seferian@institut-myologie.org name: Andreea SEFERIAN role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hautepierre Hospital - Mother and Child Hospital city: Strasbourg zip: 67200 country: France name: Vincent LAUGEL, Pr role: CONTACT phone: 03.88.12.77.43 phoneExt: +33 email: vincent.laugel@chru-strasbourg.fr name: Vincent LAUGEL, Pr role: PRINCIPAL_INVESTIGATOR lat: 48.58392 lon: 7.74553 facility: Department of Pediatrics - Neurology and Infectious Diseases Toulouse University Hospital - Children's Hospital city: Toulouse zip: 31059 country: France name: Claude CANCES, Pr role: CONTACT phone: 05.34.55.74.08 phoneExt: +33 email: cances.c@chu-toulouse.fr name: Claude CANCES, Pr role: PRINCIPAL_INVESTIGATOR lat: 43.60426 lon: 1.44367 hasResults: False

 nctId: NCT06321952 id: GTanareesuchoti briefTitle: Comparison of Accuracy and Functional Outcome Between Robotic and Gyroscopic Assisted Surgery in Primary TKA overallStatus: COMPLETED date: 2021-09-17 date: 2023-10-22 date: 2024-02-01 date: 2024-03-20 date: 2024-03-20 name: Mahidol University class: OTHER briefSummary: A randomized controlled trial was conducted with 72 participants who had moderate knee osteoarthritis (Kellgren and Lawrence grade 2-3). The patients were randomly assigned to either the robotic-assisted or gyroscopic-assisted group. Baseline characteristics, including age, body mass index, length of stay, and estimated blood loss, were recorded. The primary outcome measure was the accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months. Secondary outcomes included functional outcomes (KOOS, Oxford knee score, EQ-5D-5L, range of motion) assessed preoperatively and postoperatively at 3 months, as well as at 6 months postoperatively. conditions: Knee Arthropathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 64 type: ACTUAL name: ROSA robotic assist TKA name: iassist TKA measure: accuracy of Robotic Assisted Surgery and Gyroscopic Based Instrument measure: Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument measure: Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument measure: Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument measure: Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Siriraj Hospital city: Bangkok zip: 10700 country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06321939 id: NPCNS 001 briefTitle: Sequencing-based Counting of Plasma Epstein-Barr Virus DNA in Non-metastatic Nasopharyngeal Carcinoma overallStatus: RECRUITING date: 2024-01-11 date: 2026-12-31 date: 2028-12-31 date: 2024-03-20 date: 2024-03-20 name: Hunan Cancer Hospital class: OTHER briefSummary: The investigators aim to explore a new EBV DNA surveillance method with both high sensitivity and specificity in nasopharyngeal carcinoma (NPC) patients. the investigators aim to conduct plasma EBV DNA counting by next generation sequencing (NGS) in non-metastatic NPC patients on their diagnose, after two cycles of induction chemotherapy (IC), and 4-8 weeks after definitive radiotherapy. The investigators aim to explore whether sequencing-based counting is better than PCR analysis in plasma EBV-DNA surveillance, so as to monitoring tumor responses to treatment and for guiding individualized treatment adaptation in the future. conditions: Nasopharyngeal Carcinoma conditions: Herpesvirus 4, Human studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: EBV-DNA next generation sequencing measure: Positivity rate of plasma EpsteineBarr virus (EBV) DNA by next generation sequencing measure: Overall survival measure: Distant metastasis failure-free survival measure: Locoregional failure-free survival measure: Failure-free survival measure: Patient reported quality-of-life score measure: Biomarker analysis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hunan cancer Hospital status: RECRUITING city: Changsha state: Hunan country: China name: Yaqian Han role: CONTACT phone: +8618673176667 email: hanyaqiancs@163.com lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06321926 id: 154/2023 briefTitle: Evaluation of the "ActiveWaiting App" Encouraging Active Exercise-related Use of Waiting Time overallStatus: RECRUITING date: 2024-04-01 date: 2024-06-30 date: 2024-06-30 date: 2024-03-20 date: 2024-04-08 name: Ludwig Boltzmann Institute for Digital Health and Prevention class: OTHER briefSummary: The goal of this study (waitlist control study) is to evaluate the effectiveness of the ActiveWaiting App on increasing physical activity and improving quality of life in physically inactive adults in Austria.

The main questions it aims to answer are:

1. Does the provision of the ActiveWaiting App lead to increased physical activity behaviour, compared to a no-intervention control group?
2. Does the provision of the ActiveWaiting App lead to increased health-related quality of life, compared to a no-intervention control group? Participants will use the ActiveWaiting App over a period of seven days. During this period, they will answer daily questionnaires (3 - 6 questions) in order to gather their actual physical activity behaviour. Before and after the intervention period additional questionnaires on health-related quality of life will be sent to the participants.

Participants in the waitlist control group will have a control period (seven days) before using the app.

Researchers will compare the intervention group with the waitlist control group to see if the ActiveWating App has an effect

* on physical activity behaviour and
* on quality of life. conditions: Physical Inactivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants are assigned to the intervention group or the waitlist control group. The intervention group uses the ActiveWaiting App for a week, the waitlist control group starts with a control period (one week), before using the App for a week. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Outcomes will be selected via lime survey. Allocation to the groups will be concealed. whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: ActiveWaiting App measure: Amount of physical activity in minutes per day measure: EQ VAS / EQ-5D-5L measure: App usage - exercise session length measure: App usage - total duration per session sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: FH Campus Wien status: RECRUITING city: Vienna country: Austria name: Andrea Greisberger, MSc role: CONTACT phone: +4316066877 phoneExt: 4717 email: andrea.greisberger@fh-campuswien.ac.at lat: 48.20849 lon: 16.37208 hasResults: False

 nctId: NCT06321913 id: CIBI343Y002 briefTitle: Study of IBI343 in Subjects With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-12-31 date: 2025-12-31 date: 2024-03-20 date: 2024-03-20 name: Harbin Medical University class: OTHER name: Innovent Biologics (Suzhou) Co. Ltd. briefSummary: The goal of this clinical trial\] is toevaluate the safety, tolerability and efficacy of IBI343 combined with sintilimab in the treatment of subjects with advanced gastric/gastroesophageal junction adenocarcinoma. The main aim is to evaluate the efficacy and safety of IBI343 combination treatment in subjects with advanced gastric/gastroesophageal junction adenocarcinoma.The secondary aim is to evaluate other efficacy endpoints in subjects with IBI343 combination therapy for advanced gastric/gastroesophageal junction adenocarcinoma.The exploratory purpose is to evaluate the correlation between CLDN18.2 expression levels in tumor tissues and the efficacy of IBI343 combination therapy.

Participants will be asked to enroll about 3-12 patients in the safety introduction period.，and about 25 patients are planned to be enrolled in the POC phase. conditions: Advanced Gastric/Gastroesophageal Junction Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: IBI343 combined with IBI308 measure: ORR measure: AE measure: Treatment-Emergent Adverse Event (TEAE) measure: Adverse Event of Special Interest (AESI) measure: Serious Adverse Event (SAE) measure: laboratory examinations measure: physical examinations measure: vital signs measure: PFS measure: Duration of Response (DoR) measure: Disease Control Rate (DCR) measure: Time to Response (TTR) measure: Overall Survival (OS) measure: CLDN18.2 expression level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06321900 id: 09M206 briefTitle: Personalized Risk Prediction of Sudden Cardiac Death acronym: RESPECT overallStatus: RECRUITING date: 2023-06-02 date: 2024-12-15 date: 2025-04-30 date: 2024-03-20 date: 2024-03-20 name: Istituto Auxologico Italiano class: OTHER briefSummary: Sudden cardiac death (SCD) is the final result of cardiac arrest (CA) , defined as an abrupt and unexpected loss of cardiovascular function resulting in circulatory collapse and death. Up to 50% of cardiac deaths in Europe are due to CA. The estimated mortality of CA is approximately 90%, and significant functional and/or cognitive disabilities often persist among those who survive. The advent of the implantable cardioverter-defibrillator (ICD) has revolutionized the prevention of SCD in high-risk patients with reduced left ventricular ejection fraction (LVEF\<35%). However, the algorithm recommended by current guidelines based on LVEF, considered the only parameter to identify high-risk patients, cannot stratify the population and the spectrum of risk with high accuracy. Although the risk of CA is higher among patients with LVEF\<35% and NYHA class\>1, because of the enormity of the population size at risk (i.e., with organic heart disease and LVEF\>35%), most SCD does occur in patients with LVEF\>35%. Additionally, the majority of pts who receive the ICD for primary prevention of SCD will not benefit from the device (in the Sudden Cardiac Death in Heart Failure Trial published in 2005, the rate of appropriate ICD therapy was 21% at five years), and/or will experience some side effects of it. In the Israeli registry of patients who underwent ICD (n= 1729) or cardiac resynchronization therapy (n= 1326), the 12-year cumulative incidence of adverse events was 20% for inappropriate shock, 6% for device-related infection, and 17% for lead failure.

Moreover, recent improvements in drug treatment for HF and myocardial revascularization have further reduced the incidence of SCD in pts with low LVEF. Finally, pts with advanced HF are unlikely to benefit from ICD therapy because of the high rates of non-arrhythmic deaths. Therefore, improved risk stratification approaches to guide the selection of pts for ICD implantation are needed, and only a multiparametric approach may aim to personalize the risk prediction of SCD across the broad spectrum of the phenotypes of HF patients.

The RESPECT project has been designed to personalize the risk of SCD by integrating and interpreting information highly multidisciplinary: clinical and bio-humoral, genetics and electrocardiography, conventional and advanced cardiac imaging, and data science. The investigators hypothesized that machine learning models capable of dealing with non-linearities and complex interactions among predictors, including genetic, clinical, electrocardiographic, bio-humoral, echocardiographic, cardiac magnetic resonance (CMR), and nuclear cardiology data, would have superior accuracy in predicting the occurrence of SCD compared with the currently recommended metrics of NYHA class and LVEF by two-dimensional echocardiography and that the personalized risk prediction of SCD will translate in more cost-effective use of ICDs. In addition, the investigators will use the multiparametric predictive models to develop a cloud-computing app that will allow clinicians to predict the risk of occurrence of SCD based on specific covariate profiles of individual patients. conditions: Sudden Cardiac Death Due to Cardiac Arrhythmia conditions: Cardiomyopathies conditions: Ischemic Heart Disease conditions: Cardiovascular Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1050 type: ESTIMATED name: Personalized risk model measure: Sudden cardiac death sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano IRCCS status: RECRUITING city: Milan zip: 20145 country: Italy name: Luigi Badano, PhD role: CONTACT phone: +390261911 phoneExt: 2319 email: l.badano@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06321887 id: 5155 briefTitle: EffiCacy and sAfEty of Low doSe orAl iRon for Anaemia in IBD acronym: CAESAR overallStatus: RECRUITING date: 2023-10-20 date: 2024-10-01 date: 2025-10-01 date: 2024-03-20 date: 2024-03-20 name: Liverpool University Hospitals NHS Foundation Trust class: OTHER_GOV briefSummary: Iron deficiency anaemia (IDA) is common in inflammatory bowel disease (IBD). However, although iron is commonly prescribed, the amount of elemental iron needed to achieve clinical efficacy, and the optimal method of supplementation, are under debate. This pilot study aims to investigate the efficacy and safety of low dose and standard dose oral iron preparations for the treatment of IDA in patients with IBD. conditions: Inflammatory Bowel Disease conditions: Iron Deficiency Anemia studyType: INTERVENTIONAL phases: PHASE3 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: This is an adaptive, open label study to compare the efficacy and tolerability of 8 weeks of low dose oral iron, in the treatment of iron deficiency anaemia in patients with inflammatory bowel disease (IBD). primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Ferrous fumarate syrup 2.5ml/70mg (22.5mg elemental iron) name: Ferrous fumarate syrup 2.5ml/70mg(45mg elemental iron) name: Ferrous fumarate syrup 2.5ml/70mg (90mg elemental iron) measure: Change in haemoglobin concentration from baseline to week 8. measure: Assessment of iron stores at baseline and week 8 measure: Assessment of faecal calprotectin at baseline and week 8 measure: Assessment of IBD severity. For ulcerative colitis this will be done using simple colitis clinical activity index (SCCAI). Values calculated at week 0 and week 8. measure: Assessment of IBD severity. For Crohn's disease (or IBD-unclassified) the Harvey Bradshaw Index (HBI) will be used. Values calculated at week 0 and week 8. measure: Assessment of quality of life using the IBD-QUK score at baseline and week 8 measure: Assessment of patient global assessment of symptom severity by visual analogue score at baseline and week 8. measure: Assessment of fatigue at baseline and week 8 using IBD-F fatigue score measure: Assessment of possible drug-related side effects: nausea, diarrhoea, mood disturbance, sleep disturbance - will all be assessed at baseline and week 8. measure: Experimental arm 1: Assessment of faecal metabolome composition at baseline and week 8 measure: Experimental arm 2: Assessment of faecal microbiota composition at baseline and week 8 sex: ALL minimumAge: 18 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Liverpool University Foundation NHS Trust status: RECRUITING city: Liverpool country: United Kingdom name: S Subramanian role: CONTACT phone: 01517062000 email: RGT@liverpoolft.nhs.uk name: T Conley role: CONTACT phone: 01517062000 email: RGT@liverpoolft.nhs.uk lat: 53.41058 lon: -2.97794 hasResults: False

 nctId: NCT06321874 id: EPHIRAS briefTitle: Effects of Oxygen After Abdominal Oncological Surgery acronym: EPHIRAS overallStatus: COMPLETED date: 2011-01-01 date: 2011-11-01 date: 2011-11-01 date: 2024-03-20 date: 2024-04-10 name: Jules Bordet Institute class: OTHER briefSummary: The aims of the research is to determine whether a Hyperoxic intermittent stimuli protocol can increase reticulocyte counts, signififying a rise in EPO production, in patients undergoing abdominal surgery conditions: Abdominal Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomization was conducted post-surgery in a 1:1 ratio across groups: Normobaric Oxygen Paradox (NOP) group, and a control (CTR) group. The NOP group received 60% oxygen for two hours on days 1, 3, and 5 post-surgery using a venti-mask. The CTR group did not receive oxygen therapy during the post-operatory period starting from day 1. All patients could receive oxygen during the surgery and the first 24 hours post-surgery (day 0) as needed. The belonging to one group or the other was blinded to the laboratory staff. primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: The belonging to one group or the other was blinded to the laboratory staff. whoMasked: CARE_PROVIDER count: 49 type: ACTUAL name: Oxygen measure: Percentage change in reticulocyte count measure: haematocrit levels mesure measure: haemoglobin levels mesure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Khalife Maher city: Brussels zip: 1000 country: Belgium lat: 50.85045 lon: 4.34878 hasResults: False

 nctId: NCT06321861 id: Caffeine_motivation briefTitle: Motivational, Affective and Performance Effects of Caffeine Supplementation overallStatus: RECRUITING date: 2024-01-19 date: 2024-05-01 date: 2024-05-01 date: 2024-03-20 date: 2024-03-20 name: Jagiellonian University class: OTHER name: The Jerzy Kukuczka Academy of Physical Education in Katowice name: University School of Physical Education, Krakow, Poland briefSummary: The main objective of the study is to evaluate the influence of caffeine intake on participants' energetic arousal, affect, motivation to achieve a training goal, satisfaction with training, and the sense of agency during training. Consequently, participants will engage in three sessions: caffeine, placebo, and no substance (in counterbalanced order). During each session, their affective and motivational states will be assessed, along with the performance of a standardized physical exercise test. The investigators hypothesize that participants who consume caffeine (caffeine condition) will exhibit higher levels of energy and motivation compared to the other two groups. Additionally, they are expected to experience greater optimism and expectancy regarding their training goals and achieve better results in the physical exercise test.

A secondary aim of the study is to examine the impact of genetic variability on motivational and affective states of participants, as well as their performance in the physical exercise test after caffeine. The investigators will assess the CYP1A2 (-163C \> A, rs762551; characterized such as "fast" (AA genotype) and "slow" caffeine metabolizers (C-carriers)) and ADORA2A (1976T \> C; rs5751876; characterized by "high" (TT genotype) or "low" sensitivity to caffeine (C-carriers)). conditions: Caffeine conditions: Affect conditions: Goals studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Each participant will take part in three similar sessions differing by the substance they receive: caffeine (intervention group), placebo, no substance. Sessions will be about one week apart. primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Caffeine name: Placebo name: No substance measure: Energetic arousal pre-test measure: Energetic arousal post-test measure: Optimism measure: Motivation measure: Determination measure: Relative outcome expectancy measure: Success probability measure: Prospective effort measure: Agency measure: Performance in the 1RM test measure: Performance in the bar velocity in the bench press test measure: Performance in the strength-endurance test measure: Performance in the countermovement jump test measure: Satisfaction with the results measure: Retrospective effort measure: Retrospective agency measure: Goal importance measure: Prospective difficulty measure: Expected performance in the 1RM test measure: Expected performance in the bar velocity in the bench press test measure: Expected performance in the strength-endurance test measure: Expected performance in the countermovement jump test measure: Retrospective difficulty measure: Energetic arousal post-training measure: Perceived effect on agency measure: Tense arousal measure: Hedonic tone sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: The Jerzy Kukuczka Academy of Physical Education in Katowice status: RECRUITING city: Katowice country: Poland name: Aleksandra Filip-Stachnik role: CONTACT lat: 50.25841 lon: 19.02754 hasResults: False

 nctId: NCT06321848 id: DUCGM2426 briefTitle: Weaning Ventilator Using Heart, Lung And Diaphragm Ultrasound overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-04 date: 2024-03-20 date: 2024-03-20 name: Hanoi Medical University class: OTHER briefSummary: Postextubation distress is detrimental to the prognosis of critically ill patients with successful spontaneous breathing trial. Failure to wean is known to be connected with heart, lung, and diaphragm problems. The aim of this study was to investigate how a composite model comprising diaphragm, lung, and heart ultrasonography indications could predict the weaning outcome.

Methods: Ultrasonic features of the diaphragm, heart, and lungs are going to be collected along with clinical data about the patients. Either the successful weaning group or the failed weaning group is going to comprised the patients. Multivariate logistic regression analysis is going to be used to identify the variables that may be associated with the likelihood of weaning failure. A multiindicator combination model is going to be developed to increase the predictive accuracy after the possible indicators' accuracy in foretelling the weaning outcome was assessed. conditions: Ventilator Weaning conditions: Ultrasound studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 190 type: ESTIMATED measure: The ventilator weaning outcome measure: The hospital length of stay measure: The ICU length of stay measure: The duration of mechanical ventilation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06321835 id: 16-10/13 briefTitle: The Effect of Different Patient Positions on Endotracheal Tube Cuff Pressure overallStatus: COMPLETED date: 2016-12-09 date: 2018-01-15 date: 2018-06-15 date: 2024-03-20 date: 2024-03-20 name: Ege University class: OTHER briefSummary: Background: The placement of a cuffed endotracheal tube for the administration of general anesthesia is a routine procedure. In the part of the intubation tube located in the trachea, there is a balloon (cuff) to prevent gase leakage, aspiration of secretions and gastric contents into the lungs. Inadequate inflation of cuff may lead to inadequate ventilation, aspiration and associated complications, while excessive inflation may cause complications in ranging from postoperative pharyngeal complaints to tracheal rupture due to increased cuff pressure. This study aimed to determine the effect of different patient positions on the endotracheal cuff pressure in patients undergoing urological procedures.

Methods: This is a prospective study conducted on 200 patients undergoing urological procedures in supine, prone, lateral flank and litotomy positions. After intubation (T0), the cuff pressure was checked with a cuff manometer and adjusted at 25 cmH2O as the baseline and continuously monitored. The cuff pressure was checked again before (T1) and after achieving the final position (T2) and then at 5 (T3), 10 (T4), 15 (T5), 30, 45, 60, 90, 120, 150, 180 minutes after the position, at the end of the procedure (T6) and before extubation (T7). At postoperative 2nd and 12th hours, the patients were interviewed for sore throat, hoarseness and cough. conditions: Endotracheal Tube Cuff Pressure conditions: Patient Positions studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 200 type: ACTUAL name: Endotracheal tube cuff pressure measurement measure: The Effect of Different Patient Positions on Endotracheal Tube Cuff Pressure in Patients Undergoing Urological Procedures: A Prospective Study measure: The Effect of Different Patient Positions on Endotracheal Tube Cuff Pressure in Patients sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06321822 id: EPIEXOME briefTitle: Genetic Diagnosis and Personalized Medicine for Patients With Epilepsy overallStatus: RECRUITING date: 2021-08-02 date: 2025-08-02 date: 2026-12-31 date: 2024-03-20 date: 2024-03-20 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: Background Epilepsy is a common neurological disorder. It affects 50 million people worldwide and has the highest incidence in pediatric age. According to the latest classification of the ILAE (International League against Epilepsy), epilepsies are divided into lesional (symptomatic) and non-lesional/genetic forms. Symptomatic causes of epilepsy may include scarring, tumors, strokes, and brain developmental disorders such as dysplasias. In approximately 30% of epilepsies a genetic cause of epilepsy can be hypothesized. Since the identification of the first epilepsy gene in 1995, over the next 25 years over 500 genes associated with epilepsy have been identified. The importance of many genes and many gene variants identified in many genes is not yet clear and the mutations identified in different genes require confirmation with functional studies and confirmation on larger series of patients. Furthermore, the genetic defect underlying many patients with epilepsy remains unknown to this day, despite a high level of gene sequencing effort.

Molecular studies on these genes have demonstrated how pathogenic variants on these genes determine a protein dysfunction that can cause neuronal hyperexcitability and pathological synchronization of neuronal networks leading to epileptic seizures and brain dysfunction. A notable complication in the field of epilepsy genetics is represented by the fact that the concept of a gene/a disease is valid only in a few cases, as there is a high phenotypic and genotypic heterogeneity so that a gene can present different types of epilepsy even within the same family. This means that there is a complex multigenic and multifactorial genetic substrate for which the impact of a specific genetic variant is conditioned by variants of other genes. This concept is particularly valid for the most common epileptic forms such as idiopathic generalized epilepsies.

The integration of genetic analysis with epileptological characterization in clinical practice is increasingly crucial in defining a clear molecular diagnosis in patients whose disease cause would otherwise remain unknown, and potentially allows avoiding other unnecessary diagnostic investigations. It is therefore expected that this will lead to optimizing clinical management and reducing overall costs over time. The genetic finding can constitute a useful biomarker for defining the outcome of the disease and for guiding clinical decisions such as the best choice of therapy. Despite the advantages, before starting the genetic testing process, patients and their family members should be informed about the ethical issues that may arise from genetic testing, the technical limitations, legal aspects and costs of genetic investigation.

Aim of the study Characterization of patients with epilepsy recruited at the Hospital Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan (Italy) and analysis with exome NGS sequencing of patients with the highest probability of genetic diagnosis with exome (use of a probability score)

Endpoints of study are the following:

1. Identification of the genetic cause of the forms of genetic epilepsies with the highest probability of molecular diagnosis with exome
2. Clinical-instrumental and epileptological characterization according to the ILAE classification of patients with epilepsy followed at the Fondazione IRCCS Ca' Granda Fondazione Ospedale Maggiore Policlinico
3. Correlation of clinical and instrumental parameters (in particular EEG and neuropsychological) of epilepsy recorded on the database with etiology, outcome and response to therapy conditions: Epilepsy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 500 type: ESTIMATED name: Whole exome sequencing (WES) measure: Identification of the genetic cause in patients with clinically probable genetic epilepsy using WES measure: Clinical and epileptological characterization of patients with epilepsy according to ILAE seizure and epilepsy classification measure: Characterization of qualitative Electroencefagraphy (EEG) features of patients with the different epilepsy types measure: Quantitative EEG (qEEG) characterization of patients with the different epilepsy types measure: Characterization of the clinical and instrumental features of patients with specific genetic etiology sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: RECRUITING city: Milano zip: 20122 country: Italy name: Robertino Dilena, MD role: CONTACT phone: +390255032406 email: robertino.dilena@policlinico.mi.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06321809 id: HUTF-FM-DABDCO-01 briefTitle: Intensive Lifestyle Interventions to Overweight and Obese Patients in Primary Care overallStatus: COMPLETED date: 2022-01-25 date: 2022-10-01 date: 2022-12-01 date: 2024-03-20 date: 2024-03-21 name: Duygu Ayhan Baser class: OTHER name: Hacettepe University briefSummary: The goal of this clinical trial is to compare in the effect of different lifestyle interventions in overweight and obese participants. The main questions it aims to answer are:

* effect on anthropometric measurements
* effect on lipid profile
* effect on weight-related quality of life
* observe the differences between interventions The study participants were stratified into three groups: intervention, control-1, and control-2.
* Intervention group: They were given a calorie-restricted diet and exercise plan by a dietician or physiotherapist at their first visit, and were followed up by telephone calls at weeks 2, 4, 6, 8 and 10 over 12 weeks.
* Control-1 group: During the initial medical interview, the participants were given a calorie-restricted diet programme by a dietician and an exercise programme by a physiotherapist; they were followed up over 12 weeks with telephone calls at week 4.
* Control-2 group: The participants were not provided with any programme, and the importance of weight loss was emphasised by the family physicians. Dietary and physical activity advice was given according to the recommendations in the Turkish Endocrine and Metabolism Association 2019 Obesity Diagnosis and Treatment Guide, and was followed up with phone calls at weeks 2, 4, 6, 8 and 10 over a 12-weeks. conditions: Obesity conditions: Life Style conditions: Lifestyle, Sedentary studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 152 type: ACTUAL name: intensive lifestyle measure: primary outcome sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Hacettepe University city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06321796 id: WCG IRB Protocol #20235847 briefTitle: Microbiota Transfer Therapy for Children and Adults With Both Pitt Hopkins Syndrome and Gastrointestinal Disorders overallStatus: RECRUITING date: 2024-02-27 date: 2025-02 date: 2025-05 date: 2024-03-20 date: 2024-03-20 name: Gut-Brain-Axis Therapeutics Inc. class: OTHER name: Pitt Hopkins Research Foundation briefSummary: The investigators propose to investigate Microbiota Transfer Therapy (MTT) for treating patients with Pitt-Hopkins Syndrome (PTHS) and gastrointestinal problems (constipation, bloating, abdominal pain). MTT involves a combination of 10 days of oral vancomycin (an antibiotic to kill pathogenic bacteria), followed by 1 day of bowel cleanse using magnesium citrate, followed by 4 days of high dose MTP-101P with an antacid, followed by 12 weeks of a lower maintenance dose of MTP-101P with an antacid. conditions: Pitt Hopkins Syndrome studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Part 1: Randomized, Double-Blinded, Placebo-Controlled Treatment (14 weeks) Part 2: Open-Label Observation and Cross-over or Treatment Part 3: Follow Up (Group B Only) primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: MTP-101P name: Vancomycin name: Magnesium Citrate name: Antacid name: Placebo MTP-101P name: Placebo Vancomycin measure: Daily Stool Record (DSR) measure: Safety Measures (Adverse Events) measure: Gastrointestinal Symptom Rating Scale (GSRS) measure: Clinical Global Impression - Gastrointestinal (CGI-GI) measure: Clinical Global Impression - Pitt Hopkins (CGI-PTHS) measure: Parent Global Impressions - Pitt Hopkins: Change in Symptoms (PGI-PTHS-2-Change) measure: Gastrointestinal Symptoms common in Pitt Hopkins (GI-PTHS) measure: Revised Face Legs Activity Crying Consolability Pain Questionnaire (FLACC) measure: National Survey on treatment Effectiveness for Autism (NSTEA) - Overall Benefit measure: National Survey on treatment Effectiveness for Autism (NSTEA) - Overall Adverse E sex: ALL minimumAge: 5 Years maximumAge: 55 Years stdAges: CHILD stdAges: ADULT facility: Autism/Asperger's Research Group at Arizona State University status: RECRUITING city: Tempe state: Arizona zip: 85287 country: United States name: James Adams, Phd role: CONTACT phone: 480-818-0741 email: jim.adams@asu.edu name: Jasmine Kirby, MS role: CONTACT phone: 4802343767 email: jkkirby1@gmail.com name: James Adams, PhD role: PRINCIPAL_INVESTIGATOR name: Rosa Krajmalnik-Brown, PhD role: SUB_INVESTIGATOR lat: 33.41477 lon: -111.90931 hasResults: False

 nctId: NCT06321783 id: E-77082166-604.01.02-407303 briefTitle: Relationship Between Cervical Proprioception and Endurance With Hand-eye Coordination and Postural Control overallStatus: RECRUITING date: 2023-03-06 date: 2024-07-12 date: 2024-09-06 date: 2024-03-20 date: 2024-03-20 name: Gazi University class: OTHER briefSummary: The aim of our study is to investigate the relationship between cervical proprioception and cervical muscle endurance with hand-eye coordination and postural control in individuals with forward head posture (FHP) and to compare them with a control group with normal head posture. After the demographic information and physical characteristics of the individuals are recorded, their craniovertebral angles (CVA) will be measured and they will be assigned to Group 1 (forward head posture) or Group 2 (normal head posture). Then, the individuals' cervical proprioception, hand-eye coordination, postural control and cervical muscle endurance values will be measured respectively. Cervical muscle endurance will be evaluated last, taking into account possible muscle fatigue, in order not to affect other measurement results. The recorded values will be compared between groups and the relationship of cervical proprioception and muscle endurance with hand-eye coordination and postural control will be examined. All evaluations will be made by the same researcher. conditions: Forward Head Posture studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 100 type: ESTIMATED name: Assessment measure: Cervical Proprioception measure: Hand-Eye Coordination measure: Postural Stability Test measure: Stability Limit Test measure: Modified Sensory Organization Test measure: Endurance of Cervical Muscles sex: ALL minimumAge: 18 Years maximumAge: 24 Years stdAges: ADULT facility: Gazi University status: RECRUITING city: Ankara state: Çankaya zip: 06490 country: Turkey name: Tuğçe Çoban, MSc role: CONTACT phone: +905454098540 email: fzttugce@yahoo.com lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06321770 id: 075-2022 briefTitle: Oral Supplementation With Active Collagen Peptides and Skin Health Improvement overallStatus: COMPLETED date: 2023-03-15 date: 2023-04-16 date: 2023-05-24 date: 2024-03-20 date: 2024-03-20 name: Gala Servicios Clinicos S.L. class: OTHER briefSummary: The present study aims to investigate the efficacy of daily supplementation with COLLinstant® LMW over a 6-week period in improving visible signs of aging. This in-cludes assessing its impact on skin wrinkle reduction, as well as its potential to en-hance skin elasticity and moisturization. COLLinstant® LMW was administered orally in a single-center, randomized, double-blind, placebo-controlled clinical trial. A sec-ondary objective involves comparing skin improvement, product satisfaction, and monitoring adverse events among middle-aged female volunteers. conditions: Facial Wrinkles conditions: Skin Hydration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, Double-Blind, Placebo-Controlled Study primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Randomized, Double-Blind, Placebo-Controlled Study whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ACTUAL name: Bioactive collagen peptides name: Placebo measure: Skin wrinkling volume (px^3) measure: Skin wrinkling area (px^2) measure: Skin wrinkling depth (px) measure: R0= Skin firmness (mm) measure: R2= gross elasticity (%) of the skin measure: R5= Skin net elasticity (%) measure: R7= Skin elastic recovery (%) measure: R9= Skin fatigue (mm) measure: Skin hydration (AU) measure: Subjective perception of product efficacy measure: Subjective perception of the organoleptic characteristics of the product measure: Opinion on the degree of satisfaction with the product sex: FEMALE minimumAge: 30 Years maximumAge: 60 Years stdAges: ADULT facility: GALA Laboratories city: Don Benito state: Badajoz zip: 06400 country: Spain lat: 38.95627 lon: -5.86162 hasResults: False

 nctId: NCT06321757 id: EPIC30-PARIS briefTitle: PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients acronym: PARIS overallStatus: RECRUITING date: 2024-02-26 date: 2025-09-30 date: 2026-12-30 date: 2024-03-20 date: 2024-04-22 name: Fundación EPIC class: OTHER briefSummary: Post-market, prospective, observational, multicenter, non-intervention study, to demonstrate the effectiveness of drug-coated ballon (DCB)therapy in real-world patients with small native vessel coronary artery disease, and to demonstrate the safety of short dual antiplatelet therapy (7 days) in high-bleeding risk patients with native small vessel coronary artery disease treated with DCB therapy. A percutaneous coronary intervention (PCI) with DCB will be performed in patients with native vessel coronary artery disease based on the criterion of the treating physician. conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 501 type: ESTIMATED name: Percutaneous Coronary Intervention with DCB and DAPT measure: Effectiveness of DCB therapy measure: Cardiac death measure: All-cause mortality measure: Target vessel myocardial infarction measure: New target lesion revascularization (TLR) measure: Target vessel failure (TVF) measure: Major bleeding measure: Minor bleeding measure: 1-year MACE indicende (cardiac mortality, myocardial infarction, and new revascularization of the target lesion) in high-bleeding risk patients treated with a short dual antiplatelet treatment (7 days) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Clinico San Cecilio status: RECRUITING city: Granada zip: 18016 country: Spain lat: 37.18817 lon: -3.60667 facility: Hospital Universitario Juan Ramon Jimenez status: RECRUITING city: Huelva zip: 21005 country: Spain lat: 37.26638 lon: -6.94004 facility: Hospital Universitario de Leon status: RECRUITING city: León zip: 24071 country: Spain lat: 42.60003 lon: -5.57032 facility: Hospital Universitario Y Politecnico La Fe status: RECRUITING city: Valencia zip: 46026 country: Spain lat: 39.46975 lon: -0.37739 facility: Hospital Clinico Universitario de Valladolid status: RECRUITING city: Valladolid zip: 47003 country: Spain lat: 41.65518 lon: -4.72372 hasResults: False

 nctId: NCT06321744 id: 2023/825 briefTitle: Study Evaluating the Feasibility of an Adapted Physical Activity Program During the Hospitalization Phase in Cancer Patients Undergoing Treatment acronym: PREVAPA overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-20 date: 2024-03-20 name: Centre Hospitalier Universitaire de Besancon class: OTHER briefSummary: This is a non-randomized, non-controlled feasibility study which will take place at the Besançon University Hospital in the conventional hospitalization department.

It will be carried out with patients hospitalized in the conventional hospitalization department of the medical oncology department of Besançon University Hospital.

At entry, after presenting the study and obtaining non-opposition from patients, an initial assessment will be carried out before the APA program. This assessment will include an evaluation of physical parameters (measurements of body composition, functional capacities, autonomy in activities of daily living and muscular strength), as well as an evaluation of quality of life relating to health and motivation to practice physical activity.

At the end of the initial assessment, an APA program supervised (individually and in a room) by an APA teacher will be offered to patients. The sessions will be offered daily to patients (maximum 5 times/week). They will last on average 20 minutes each depending on the fatigue, pain and fitness of the patients. The objectives pursued are mainly an improvement in functional independence and mobility. conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 32 type: ESTIMATED name: adapted physical activity program (APA Program) measure: Validate the feasibility of a supervised adapted physical activity (APA) program during the first 7 days of hospitalization in medical oncology for patients with cancer undergoing treatment measure: Describe the evolution of body composition measured by impedancemetry measure: Describe the evolution of physical parameters functional capacities measure: Describe the evolution of autonomy in daily life activities measure: Describe the evolution of muscular strength measure: Describe the evolution of the quality of life measure: Describe the evolution of motivation to practice physical activity measure: Tolerance with the APA program on perception of effort measure: Tolerance with the APA program on pain and fatigue measure: Tolerance with the APA program on fatigue measure: Compliance with the APA program measure: Criteria/reasons for non-participation, non-compliance, discontinuation of the intervention and study withdrawals measure: Patient satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06321731 id: D5980R00096 briefTitle: Real-World Outcomes in COPD Patients Starting Trixeo (Budesonide/Glycopyrronium/Formoterol) in Spain. acronym: ORESTES overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-11-30 date: 2024-11-30 date: 2024-03-20 date: 2024-03-20 name: AstraZeneca class: INDUSTRY briefSummary: The aim of the ORESTES study is to describe the characteristics of the COPD patients initiating Trixeo (BGF -budesonide/glycopyrronium/formoterol) in Spain and to assess their real-world outcomes up to 12 months afterwards.

For that purpose,a descriptive, observational, multi-centre, longitudinal, retrospective cohort study involving \~20 Spanish centres and aiming to include between 500 and 700 patients, has been designed. conditions: Chronic Obstructive Pulmonary Disease (COPD) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 500 type: ESTIMATED measure: Annualized rate of exacerbations after BGF initiation measure: Demographic and clinical profile of patients initiating BGF. measure: Lung Function after BGF initiation measure: Eosinophils count after BGF initiation measure: Persistence to treatment (BGF) measure: Need for rescue medication after BGF initiation measure: Use of oral corticosteroids (OCS) after BGF initiation measure: HCRUs related to COPD after BGF initiation measure: Annualized rate of severe cardiovascular (CV)-related outcomes after initiation of BGF. measure: Mortality (% and time to event) after BGF initiation sex: ALL minimumAge: 40 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06321718 id: 04-2023-200629 briefTitle: Pericapsular Nerve Group Block vs Supra Inguinal Fascia Iliaca Compartment Block overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-03-01 date: 2025-04-01 date: 2024-03-20 date: 2024-03-20 name: Assiut University class: OTHER briefSummary: This study aims to assess the efficacy of PENG block performed with LFCN block in controlling postoperative pain and promoting motor function recovery and to compare its effectiveness with S-FICB. conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 96 Patients will be enrolled. Choice of type of anesthesia will be established according to every individual patient, but spinal anesthesia will be preferred over general anesthesia. The block will be administered under supervision of the supervisor senior staff before induction of anesthesia. 2 groups well be assessed

1. Group (A) will receive PENG + LFCN block
2. The second group (B): S-FICB primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Through website computer program randomization program to distribute cases into two groups using their order number whoMasked: PARTICIPANT count: 96 type: ESTIMATED name: PENG + LFCN block versus S-FICB measure: recording time for "return of full muscle power" measure: • The degree of hip flexion on the operative side measure: • Static and dynamic pain scores. measure: postoperative nausea and vomiting (PONV) scale measure: • The number of rescue analgesia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06321705 id: CS1-004 briefTitle: Safety and Efficacy of Continued CS1 Treatment of Patients With Pulmonary Arterial Hypertension overallStatus: AVAILABLE date: 2024-03-20 date: 2024-03-20 name: Cereno Scientific AB class: INDUSTRY name: Worldwide Clinical Trials name: Abbott briefSummary: CS1-004 will be an extension of the CS1-003 Study. The primary objective of the CS1-004 study is to evaluate long-term safety and tolerability of continued treatment with CS1. conditions: Pulmonary Arterial Hypertension studyType: EXPANDED_ACCESS name: CS1 sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fredrik Frick status: AVAILABLE city: Gothenburg country: Sweden name: Fredrik Frick role: CONTACT phone: +46725479566 email: Fredrik.Frick@cerenoscientific.com lat: 57.70716 lon: 11.96679 hasResults: False

 nctId: NCT06321692 id: IEO 1003 briefTitle: Early Identification of Cardiac Involvement in Patients With Carcinoid: Clinical and Prognostic Implications overallStatus: RECRUITING date: 2019-10-09 date: 2024-12-31 date: 2024-12-31 date: 2024-03-20 date: 2024-03-20 name: European Institute of Oncology class: OTHER briefSummary: This study is for patients with neuroendocrine tumours (NET) with or without carcinoid syndrome followed by NET Unit of European Institute of Oncology.

The objective of the trial is to evaluate biochemical markers of myocardial injury (high-sensitive troponins), haemodyinamic markers (pro-brain natriuretic peptide (BNP), N-terminal (NT)-BNP (NT-proBNP)), and markers of fibrosis (Suppression of Tumorigenicity 2 (ST2) in patients with neuroendocrine tumours (NET) with or without carcinoid syndrome. conditions: Neuroendocrine Tumors studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: Evaluation of blood levels of biomarkers of cardiac damage measure: blood levels of biomarkers of cardiac damage measure: blood levels of biomarkers of hemodynamic impairment measure: blood levels of biomarkers of cardiac fibrosis measure: Correlation between the levels of the biomarkers and the presence/entity of cardiac involvement sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Daniela Cardinale, MD role: CONTACT email: daniela.cardinale@ieo.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06321679 id: IEO 1269 briefTitle: Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer to the Bone acronym: RESPECT overallStatus: RECRUITING date: 2020-07-03 date: 2024-12-31 date: 2027-12-31 date: 2024-03-20 date: 2024-03-20 name: European Institute of Oncology class: OTHER briefSummary: This study is aimed to compare whole body MRI (WB-MRI) with Bone Scintigraphy (BS) and Computerized Tomography (CT) scans in patients receiving treatment for metastatic castration-resistant prostate cancer to the bone.

This is a monocentric, prospective observational study. conditions: Castration-resistant Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Imaging evaluation measure: Time to disease progression in bone metastasis identify by WB-MRI sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IEO Istituto Europeo di Oncologia status: RECRUITING city: Milan zip: 20141 country: Italy name: Giuseppe Petralia role: CONTACT email: giuseppe.petralia@ieo.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06321666 id: IEO 0986 briefTitle: Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone acronym: RESPECT-MI overallStatus: ACTIVE_NOT_RECRUITING date: 2019-09-12 date: 2024-12-31 date: 2024-12-31 date: 2024-03-20 date: 2024-03-20 name: European Institute of Oncology class: OTHER briefSummary: This is a non randomized, single arm study, where each patient will undergo imaging with Computed Tomography (CT) and Whole-body magnetic resonance imaging (WB-MRI) at different timepoint. The primary endpoint is time to progression as documented by CT or WB-MRI. conditions: Metastatic Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 58 type: ACTUAL name: WB-MRI measure: Proportion of disease progression in bone metastasis identified by WB-MRI prior to CT scan sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IEO Istituto Europeo di Oncologia city: Milan zip: 20141 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06321653 id: IEO 0953 briefTitle: Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes acronym: AXILL-ART overallStatus: RECRUITING date: 2019-04-18 date: 2024-12-31 date: 2027-12-31 date: 2024-03-20 date: 2024-03-20 name: European Institute of Oncology class: OTHER briefSummary: In this observational prospective studi patients with invasive breast cancer no more than 5 cm and clinically node negative, scheduled for conservative surgery and Sentinel Node Biopsy (SNB), are enrolled in the protocol if they have 1-2 sentinel lymphnodes (SLNs) with macrometastases. SLN status will be checked on definitive sections. conditions: Arm Lymphedema conditions: Breast Cancer conditions: Radiotherapy Side Effect studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Hypofractionated radiotherapy scheme measure: Percentage of patients with arm lymphedema measure: Evaluation of cute locoregional toxicity at breast and axilla measure: Evaluation of chronic toxicity at breast and axilla measure: Disease free survival measure: Overall survival measure: Quality of life (QoL) in order to evaluate pain, itching and burning at breast or axilla sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Maria Cristina Leonardi role: CONTACT phone: +39 02 94372156 lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06321640 id: IEO 1777 briefTitle: Study for the Multidimensional Analyses of Resistance and Toxicity to Immune- and Targeted-therapies. acronym: POSITive overallStatus: RECRUITING date: 2022-07-08 date: 2024-12-31 date: 2025-12-31 date: 2024-03-20 date: 2024-03-20 name: European Institute of Oncology class: OTHER briefSummary: Novel treatment modalities like targeted therapies and Immune checkpoint inhibitors have revolutionised the therapeutic landscape in oncology and hematology, significantly improving outcomes even in clinical contexts in which little improvement had been observed for decades such as metastatic melanoma, lung cancer, and lymphoproliferative neoplasms such as chronic lymphoid leukemia or Hodgkin lymphoma. However, major issues remain unsolved, given the frequent occurrence of primary or secondary resistance and the still incomplete understanding of the physiopathology of adverse events, which represent a major cause of morbidity and treatment interruption and often remain difficult to treat and diagnose. In this complex landscape, identifying the best treatment option for each patient remains challenging. For both targeted therapies and Immune checkpoint inhibitors, several biomarkers have been reported, but their implementation in clinical practice is still uncommon, and most of the decision-making process remains based on purely clinical considerations or constraints dictated by the regulatory bodies. Obstacles to biomarker-driven decision making are manifold and include insufficient understanding of the underlying biology, lack of strong evidence on their predictive power and limited tumor sampling, which may be circumvented by non-invasive techniques such as liquid biopsies. conditions: Breast Cancer conditions: Lung Cancer conditions: Melanoma conditions: Head and Neck Cancer conditions: Urothelial Carcinoma conditions: Colorectal Cancer conditions: Liver Metastases conditions: Lung Metastases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 265 type: ESTIMATED name: Cohort A: primarily operable disease, candidate to adjuvant name: Cohort B: locally advanced disease name: Cohort C: metastatic disease name: Cohort D: Progressive disease name: Cohort E: Hematological neoplasms name: Cohort F: Toxicity measure: Percentage of patients in each cohort that will obtain a full "core" omic characterization. measure: Percentage of patients with complete clinical data collection over the expected follow-up time and with successful biobanking. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of oncology status: RECRUITING city: Milan country: Italy name: Giuseppe Curigliano role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06321627 id: IEO 1811 briefTitle: Radiosensitivity of HPV-related Tumors: Towards a Genomic Approach acronym: ICARUS overallStatus: RECRUITING date: 2023-04-14 date: 2024-12-31 date: 2024-12-31 date: 2024-03-20 date: 2024-03-20 name: European Institute of Oncology class: OTHER briefSummary: The purpose of this study is therefore to analyze the genomic profiles of prognosis and radiosensitivity of Human Papilloma Virus (HPV) related tumors from different body sites (oropharynx, uterine cervix, and anus), considering them as a unified entity regardless of the site of origin within the body. conditions: HPV-Related Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Radiation therapy as curative treatment measure: Disease free survival measure: Genetic patterns of radiosensitivity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Daniela Alterio, MD role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06321614 id: 2022098 briefTitle: Deep Learning in Classifying Bowel Obstruction Radiographs overallStatus: ACTIVE_NOT_RECRUITING date: 2022-12-31 date: 2024-04-30 date: 2024-12-31 date: 2024-03-20 date: 2024-03-20 name: The First Affiliated Hospital of Soochow University class: OTHER briefSummary: Background: Accurate labeling of obstruction site on upright abdominal radiograph is a challenging task. The lack of ground truth leads to poor performance on supervised learning models. To address this issue, self-supervised learning (SSL) is proposed to classify normal, small bowel obstruction (SBO), and large bowel obstruction (LBO) radiographs using a few confirmed samples.

Methods: A few number of confirmed and a large number of unlabeled radiographs were categorized based on the ground truth. The SSL model was firstly trained on the unlabeled radiographs, and then fine-tuned on the confirmed radiographs. ResNet50 and VGG16 were used for the embedded base encoders, whose weights and parameters were adjusted during training process. Furthermore, it was tested on an independent dataset, compared with supervised learning models and human interpreters. Finally, the t-SNE and Grad-CAM were used to visualize the model's interpretation. conditions: Digestive System Disease conditions: Polyp of Colon conditions: Bowel Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 4500 type: ESTIMATED measure: Diagnostic and classification performance measure: Visualized interpretation of the self-supervised model sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: TheFirst Affiliated Hospital of Soochow University city: Suzhou state: Jiangsu zip: 215006 country: China lat: 31.30408 lon: 120.59538 hasResults: False

 nctId: NCT06321601 id: 20230070 briefTitle: Study to Evaluate Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen, in Children From 6 Years to < 18 Years of Age With AAV overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2030-04-28 date: 2030-04-28 date: 2024-03-20 date: 2024-03-20 name: Amgen class: INDUSTRY briefSummary: The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV. conditions: Vasculitis studyType: INTERVENTIONAL phases: PHASE3 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Avacopan measure: Proportion of Participants Achieving Disease Remission at Week 26 According to the Pediatric Vasculitis Activities Score (PVAS) measure: Proportion of Participants With Sustained Disease Remission at Week 52 According to the PVAS measure: Plasma Concentrations of Avacopan measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) measure: Proportion of Participants Achieving Disease Remission at Week 26 According to the Birmingham Vasculitis Activity Score (BVAS) measure: Proportion of Participants Achieving Disease Remission at Week 52 According to the BVAS measure: Proportion of Participants With PVAS of 0 Over Time Through Week 52 measure: Proportion of Participants With BVAS of 0 Over Time Through Week 52 measure: Change From Baseline Over 52 Weeks in Urinary Albumin-Creatinine Ratio (UACR) measure: Change From Baseline Over 52 Weeks in Estimated Glomerular Filtration Rate (eGFR) measure: Change From Baseline Over 52 Weeks In Physician Global Assessment (PGA) of Disease Activity measure: Change From Baseline Over 52 Weeks in Pediatric Vasculitis Damage Index (PVDI) measure: Number of Glucocorticoid Dosages Administered measure: Proportion of Participants Across the Taste Score Categories of the TASTY Faces Scale measure: Taste and Acceptability Score of Avacopan per TASTY Faces Scale sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06321588 id: GR-2021-12373134 briefTitle: Autoimmune Dementia: Predictors of Neuronal Synaptic Antibodies in Patients With New-ONset Cognitive Impairment acronym: ADONIS overallStatus: RECRUITING date: 2023-05-10 date: 2026-06-30 date: 2026-06-30 date: 2024-03-20 date: 2024-03-25 name: Azienda Usl di Bologna class: OTHER_GOV briefSummary: The goal of this observational study is to investigate the frequency and the possible pathogenic role of neuronal synaptic antibodies (NSAb) in patients with cognitive impairment (CI). The main questions it aims to answer are:

1. the frequency and associated features of NSAb in patients with CI and the usefulness of a clinical score in improving autoimmune dementia (AID) diagnosis;
2. the clinical significance of NSAb in patients with CI not fulfilling the autoimmune encephalitis (AE) criteria and serum NSAb (NSAb-pos-CI);
3. the impact of blood-brain-barrier (BBB) dysfunction on their pathogenicity. conditions: Cognitive Impairment conditions: Dementia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 300 type: ESTIMATED measure: frequency of antibodies against neuronal antigens measure: frequency of antibodies against neuronal antigens measure: creation of a score that predicts the presence of NSAb measure: changes of neurodegeneration biomarkers measure: changes of neurodegeneration biomarkers measure: changes of neuroanatomy measure: changes of neuroanatomy measure: changes of inflammatory biomarkers measure: changes of inflammatory biomarkers measure: changes of brain blood barrier biomarkers measure: changes of brain blood barrier biomarkers sex: ALL minimumAge: 40 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto delle Scienze Neurologiche di Bologna status: RECRUITING city: Bologna zip: 40139 country: Italy name: Maria Pia Giannoccaro, Dr. role: CONTACT phone: 0514966117 email: mariapia.giannoccaro@ausl.bologna.it lat: 44.49381 lon: 11.33875 facility: Istituto Auxologico Italiano IRCCS status: RECRUITING city: Milano zip: 20095 country: Italy name: Federico Verde, Dr. role: CONTACT phone: +3902619112247 email: f.verde@auxologico.it lat: 45.46427 lon: 9.18951 facility: Fondazione IRCCS Istituto Neurologico Carlo Besta status: RECRUITING city: Milano zip: 20133 country: Italy name: Chiara Maria Giulia De Luca, Dr. role: CONTACT phone: +390223942498 email: chiara.deluca@istituto-besta.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06321575 id: AVA-CL-5000 briefTitle: The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial) acronym: GREAT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-11 date: 2026-11 date: 2024-03-20 date: 2024-04-01 name: Avantec Vascular class: INDUSTRY name: Bright Research Partners name: Yale Cardiovascular Research Group briefSummary: The objective of this study is to establish reasonable assurance of safety and effectiveness of the Golazo® Peripheral Atherectomy System when used as indicated in 159 subjects with symptomatic infrainguinal peripheral arterial disease (PAD) in up to 15 investigational sites in the U.S. conditions: Peripheral Arterial Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The investigation is a prospective, multicenter, non-randomized, single-arm, open-label pivotal clinical study. primaryPurpose: TREATMENT masking: NONE count: 159 type: ESTIMATED name: Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS) measure: Freedom from major adverse events (MAE) measure: Technical success measure: Change in % stenosis in target lesion after treatment with Golazo Peripheral AS measure: Procedural Success Rate measure: Clinical Success Rate measure: Rates of all adverse events classified as MAEs measure: Incidence of minor target limb amputation measure: Incidence of myocardial infarction measure: Incidence of target vessel revascularization (TVR) in the target limb measure: Incidence of angiographic procedural distal embolization in the target limb measure: Time to primary patency of the target vessels measure: Time to assisted primary patency of the target vessels measure: Time to secondary patency of the target vessels sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06321562 id: EyeD-010-003 id: 2020-002354-24 type: EUDRACT_NUMBER id: CIV-21-12-038426 type: OTHER domain: EUDAMED briefTitle: Safety and Tolerability of a Timolol Releasing Intraocular Implant in Subjects With Primary Open-angle Glaucoma overallStatus: RECRUITING date: 2023-03-01 date: 2027-07 date: 2027-07 date: 2024-03-20 date: 2024-03-25 name: EyeD Pharma class: INDUSTRY briefSummary: The purpose of this study is to test a new method to deliver an approved medicine called Timolol in the eye of participants with glaucoma and pseudophakia. The main questions it aims to answer are how safe the investigational drug is and how the body tolerates it.

The study will also check:

* how safely the implant is placed in and removed from the eye and how the body responds to the procedure,
* how safe different doses of timolol are and how the body handles taking it,
* the amount of Timolol released in the bloodstream,
* if there is any positive effect on the pressure inside the eye. conditions: Primary Open-angle Glaucoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 18 type: ESTIMATED name: TimoD implant name: Injector system measure: Number and proportion of participants experiencing one or more serious adverse events (SAEs) measure: Number and proportion of participants experiencing one or more treatment-emergent adverse events (TEAEs) overall and by dose group sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU - Service d'Ophtalmologie status: RECRUITING city: Liège zip: 4000 country: Belgium name: Nathalie Collignon, Prof. MD. role: PRINCIPAL_INVESTIGATOR lat: 50.63373 lon: 5.56749 facility: Breyer, Kaymak & Klabe Augenchirurgie status: RECRUITING city: Düsseldorf zip: 40212 country: Germany name: Karsten Klabe, MD. role: PRINCIPAL_INVESTIGATOR lat: 51.22172 lon: 6.77616 facility: Universitäts-Augenklinik Heidelberg status: NOT_YET_RECRUITING city: Heidelberg zip: 69120 country: Germany name: Gerd Auffarth, Prof. MD. role: PRINCIPAL_INVESTIGATOR lat: 49.40768 lon: 8.69079 facility: Universitätsaugenklinik Magdeburg status: RECRUITING city: Magdeburg zip: 39120 country: Germany name: Giulia Reineri, MD. role: PRINCIPAL_INVESTIGATOR lat: 52.12773 lon: 11.62916 facility: Augenklinik Sulzbach status: RECRUITING city: Sulzbach zip: 66280 country: Germany name: Karl Boden, MD. role: PRINCIPAL_INVESTIGATOR lat: 49.29882 lon: 7.05696 facility: Universitäts-Augenklinik Tübingen status: RECRUITING city: Tübingen zip: 72076 country: Germany name: Bogomil Voykov, MD. role: PRINCIPAL_INVESTIGATOR lat: 48.52266 lon: 9.05222 hasResults: False

 nctId: NCT06321549 id: 202201562B0 briefTitle: New Era of DIEP With Minimally Invasive Mastectomy overallStatus: COMPLETED date: 2022-10-03 date: 2023-10-02 date: 2023-10-02 date: 2024-03-20 date: 2024-03-20 name: Chang Gung Memorial Hospital class: OTHER briefSummary: The free deep inferior epigastric artery perforator (DIEP) flap is the gold standard in autologous breast reconstruction. Asian patients often present with a smaller body mass index with relatively insufficient tissue. To restore appropriate symmetry, a larger flap inset ratio must be transferred. Supercharging of the second vein or inclusion of bilateral pedicle is commonly required. Current paradigm shifts in mastectomy has also resulted in more minimally invasive surgeries (MIS) espousing smaller lateral incisions, leading to a significant change in available recipient vessels. This study aimed to demonstrate our experience in changing strategies of DIEP flaps following the evolution of mastectomy techniques.

Between October 2008 and March 2022, retrospective data was gathered for 278 patients who underwent breast reconstruction surgery utilizing DIEP flaps by a single plastic surgeon. These patients were divided into two distinct groups based on their operation dates, with November 2018 marking a pivotal moment when the first MIS was introduced. conditions: Breast Reconstruction conditions: Mastectomy; Lymphedema studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 278 type: ACTUAL name: The reference point of minimally invasive mastectomy procedure conducted measure: Endoscopy mastectomy measure: Robotic mastectomy measure: Incision measure: Usage of SIEV measure: Inclusion of bipedicle measure: Location of recipient artery/vein measure: Recipient artery/vein selection sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Chang Gung Memorial Hospital city: Taoyuan zip: 33305 country: Taiwan lat: 24.95233 lon: 121.20193 hasResults: False

 nctId: NCT06321536 id: STUDY00007230 id: U54CK000601 type: NIH link: https://reporter.nih.gov/quickSearch/U54CK000601 briefTitle: Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy (REACT) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-06 date: 2025-06 date: 2024-03-20 date: 2024-03-20 name: Emory University class: OTHER name: Centers for Disease Control and Prevention briefSummary: REACT is a phase two, open-label, cluster randomized, crossover study of microbiota therapy (MT) to reduce colonization with multi-drug resistant organisms (MDRO). REACT is designed to assess the safety and efficacy of MT administered to subjects colonized with a MDRO. The overarching hypothesis is that MT can reduce MDRO colonization with safety that is comparable to observation. conditions: Multi-Drug Resistant Organism Colonization studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: NONE count: 200 type: ESTIMATED name: Allogeneic Microbiota in Glycerol (9%) (AMG) measure: Difference in number of solicited Adverse Events (AEs) measure: Difference in severity of solicited AEs measure: Difference in number of unsolicited AEs measure: Difference in severity of unsolicited AEs measure: Difference in proportion of participant stool positive cultures for any target MDRO among AMG-treated compared to Observation participants measure: Count of serious AEs (SAEs) measure: Count of AEs of Special Interest (AESIs) measure: Proportion of stool cultures at Day 28 positive for category-specific MDROs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emory University Hospital city: Atlanta state: Georgia zip: 30322 country: United States name: Michael Woodworth, MD role: CONTACT phone: 404-778-1691 lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06321523 id: B3461122 briefTitle: A Study to Learn About the Study Medicine Called Tafamidis 61mg in People Diagnosed With Transthyretin Amyloid Cardiomyopathy (ATTR-CM) overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-19 date: 2025-04-30 date: 2025-04-30 date: 2024-03-20 date: 2024-04-17 name: Pfizer class: INDUSTRY briefSummary: The purpose of this clinical trial is to learn about the effects of the study medicine (called Tafamidis 61milligrams (mg)) for the potential treatment of Transthyretin amyloid cardiomyopathy (ATTR-CM).

This study is seeking participants who were prescribed Tafamidis 61mg after being diagnosed with ATTR-CM and have taken Tafamidis 61mg at least once.

We will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe and effective. conditions: Transthyretin Amyloid Cardiomyopathy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 15 type: ACTUAL name: Tafamidis 61 milligrams measure: Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification measure: Change from baseline in six-minute walk test measure: Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS) measure: Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration measure: Change From Baseline in Troponin I and Troponin T measure: number of participants with Any Heart Block measure: number of participants with Atrioventricular (AV) block measure: Change From Baseline in Left Ventricular Ejection Fraction measure: Change From a Baseline in Diastolic function grades measure: Change from Baseline in Left Ventricular Wall Thickness measure: Change From Baseline in Global Longitudinal Strain scores measure: Frequency of cardiovascular hospitalizations measure: Frequency of death due to any cause sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pfizer city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06321510 id: A7471070 briefTitle: A Study to Learn About Dacomitinib in Patients With Non-small Cell Lung Cancer. overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-15 date: 2025-03-15 date: 2024-03-20 date: 2024-03-22 name: Pfizer class: INDUSTRY briefSummary: The purpose of this study is to learn about dacomitinib for the possible treatment of lung cancer.

This study is seeking participants who:

* have lung cancer that could not be controlled.
* have a type of gene called epidermoid growth factor receptor. A gene is a part of your DNA that has instructions for making things your body needs to work.
* have received dacomitinib for their lung cancer.

All participants in this study had received dacomitinib. Dacomitinib is a tablet that is taken by mouth at home. They continued to take dacomitnib until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective. conditions: Lung Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED measure: Percentage of patients with dacomitinib dosage change and reasons measure: Percentage of patients with dacomitinib treatment discontinuation measure: Real-world overall survival (rwOS) measure: Real-world progression-free survival measure: Real-world best objective response rate (rwORR) measure: real-world intracranial response rate (rwIC-ORR) measure: real-world extracranial response rate (rwEC-ORR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06321497 id: 85711 briefTitle: Extracorporeal Carbon Dioxide Removal Using PrismaLung in Reducing Ventilator Induced Lung Injury overallStatus: RECRUITING date: 2024-02-05 date: 2027-02-28 date: 2028-02-28 date: 2024-03-20 date: 2024-03-20 name: Peninsula Health class: OTHER_GOV name: Monash University name: Baxter Healthcare Corporation briefSummary: Lung protective ventilation with low tidal volumes and low driving pressure are known to reduce mortality in mechanically ventilated patients with acute respiratory failure. This reduction in mortality is known be due to reduction of ventilator induced lung injury that occurs due to high tidal volumes and high driving pressure. When receiving such mechanical ventilation, some patients develop hypercapnia and associated hypercapnic acidosis. Such patients have an increased risk of mortality. While the exact reasons for such increase in mortality is not known, it is recommended to minimise hypercapnia and hypercapnic acidosis during lung protective ventilation. Minimally invasive extracorporeal carbon dioxide removal (ECCO2R) devices are shown to reduce hypercapnia and hypercapnic acidosis. There are several devices that are currently available in the current clinical practice. However, the effect of these devices on reduction in ventilator induced lung injury is not clearly demonstrated. This study aims to assess the use of an ECCO2R device called Prismalung in reducing ventilator induced lung injury. PrismaLung is currently used in our intensive care unit. This assessment is done by measuring interleukins in bronchoalveolar lavage fluid and blood interleukin levels as well as clinical assessment including the reduction of driving pressure. conditions: ARDS, Human studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 15 type: ESTIMATED name: Extracorporeal carbon dioxide removal measure: Reduction in driving airway pressures measure: Reduction in pulmonary inflammation assessed by interleukins in lung sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Frankston Hospital status: RECRUITING city: Frankston state: Victoria zip: 3199 country: Australia name: Ravindranath Tiruvoipati, PhD role: CONTACT phone: 0431279347 email: rtiruvoipati@phcn.vic.gov.au name: Sachin Gupta, FCICM role: CONTACT email: sachingupta@phcn.vic.gov.au lat: -38.14458 lon: 145.12291 hasResults: False

 nctId: NCT06321484 id: 23-493 briefTitle: Intraperitoneal Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cells in Recurrent Ovarian Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-11-30 date: 2031-10-31 date: 2024-03-20 date: 2024-03-20 name: Dana-Farber Cancer Institute class: OTHER name: ImmunityBio, Inc. briefSummary: The goal of this research study is to evaluate the safety and effectiveness of the use of cytokine-induced memory-like (CIML) natural killer (NK) cell therapy combined with IL-15 superagonist (N-803) in recurrent, high grade ovarian cancer (HGOC).

Names of the study therapies involved in this study are:

* CIML NK (cellular therapy)
* N-803 (a novel immune-cell stimulator) conditions: Platinum-resistant Ovarian Cancer conditions: Recurrent Ovary Cancer conditions: Ovarian Cancer conditions: Ovarian Carcinoma conditions: Ovarian Carcinoma, Recurrent studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Cytokine-Induced Memory-like Natural Killer Cells name: IL-15 Superagonist measure: Maximum Tolerated Dose (MTD) (Cohort 1) measure: Dose Limiting Toxicity (DLT) (Cohort 1) measure: Overall Response Rate (ORR) measure: Median Progression Free Survival (PFS) measure: Clinical Benefit Rate (CBR) measure: Duration of Response (DOR) measure: 6 months Progression Free Survival (PFS6) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02215 country: United States name: Rebecca Porter, MD, PhD role: CONTACT phone: 617-632-2334 email: rebecca_porter@dfci.harvard.edu name: Rebecca Porter, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Dana-Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States name: Rebecca Porter, MD, PhD role: CONTACT phone: 617-632-2334 email: Rebecca_Porter@dfci.harvard.edu name: Rebecca Porter, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06321471 id: STUDY00002858 briefTitle: AeviceMD for Pediatric Asthma Management acronym: APAM overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-02 date: 2026-02 date: 2024-03-20 date: 2024-03-20 name: Irina Dralyuk class: OTHER name: AEvice Health Pte Ltd briefSummary: A wearable remote patient monitor (AeviceMD) is to be used to monitor the respiratory health of pediatric asthma patients in this pilot study. Patients prescribed with AeviceMD should be able to gain better control over their disease during home management. Physicians should be able to optimize treatment for these patients using objective data collected from and of these patients outside of the clinic. The AeviceMD should also be used as a remote auscultation device for teleconsultations. conditions: Asthma conditions: Asthma in Children conditions: Pediatric Asthma conditions: Chronic Respiratory Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: AeviceMD measure: To evaluate the effectiveness of implementing home monitoring technology for asthma patients in delivering care to patients and in extension determine, if Aevice Medical Device can improve home management of Asthma for pediatrics patients. measure: To determine if the AeviceMD is effective as a remote auscultation tool for the facilitation of teleconsultations. sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Cedars-Sinai Medical Center city: Los Angeles state: California zip: 90048 country: United States name: Bobby Marker role: CONTACT phone: 310-423-0901 email: Robert.Marker@cshs.org name: Irina Dralyuk, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06321458 id: LightWAY briefTitle: Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity acronym: LightWAY overallStatus: RECRUITING date: 2024-04 date: 2027-12 date: 2048-12 date: 2024-03-20 date: 2024-04-25 name: Carsten Dirksen class: OTHER name: University of Copenhagen name: University of Southern Denmark name: University of Oxford name: University of Bristol name: Copenhagen Trial Unit, Center for Clinical Intervention Research briefSummary: In this trial, the aim is to assess the clinical benefits and harms, as well as cost-effectiveness of an intensive weight loss (IWL) intervention that includes total dietary replacements, behavioural support and weight-loss medication compared with existing weight management programmes within primary care for people with severe and complex obesity. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Due to the nature of the interventions, it will not be possible to blind the participants or the healthcare providers administering the interventions. In all other aspects of the trial, blinding will be employed. Outcome assessors will be blinded to group allocation. Participants will also be requested not to disclose their allocation when outcomes are assessed.

Statisticians and investigators drawing conclusions will be fully blinded. The statistical analyses will be conducted with the intervention groups coded as e.g., 'A' and 'B'. The Steering Committee will write two abstracts while the blinding is intact; one assuming the experimental intervention group is 'A' and the control intervention group is 'B', and one assuming the opposite. After these two abstracts have both obtained consensus, the code will be broken by the data manager. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: Intensive weight loss intervention name: Usual care measure: MetS-Z measure: Weight measure: Short-Form-36, mental component score measure: Gait speed measure: Weight loss (20%) measure: SAE measure: Incident eating disorders measure: Bone mineral density (BMD) assessed by DXA measure: Body composition - waist circumference measure: Body composition - fat percentage measure: Body composition - weight loss (10%) measure: Physical functioning - SENS measure: Physical functioning - SF-36 measure: Physical functioning - sit to stand test measure: Sleep measure: Medications during the intervention period measure: Metabolic health - blood pressure measure: Metabolic health - pulse measure: Metabolic health - Hb1Ac measure: Metabolic health - insulin measure: Metabolic health - HOMA2-IR measure: Metabolic health - lipids measure: Metabolic health - eGFR measure: Metabolic health - hsCRP measure: Metabolic health - Fib4 measure: Metabolic health - proteinuria measure: Metabolic health - TSH measure: Mental health - MDI measure: Mental health - WBIS-M measure: Mental health - EDE-Q measure: Labour market attachment - WPAI measure: Labour market attachment - days of sick leave measure: Genetic profiles' (using comprehensive genetic mapping) association with the metabolic and/or weight loss response to IWL vs usual care measure: Health economy: Within-trial cost-effectiveness analysis - quality of life, index score measure: Health economy: Within-trial cost-effectiveness analysis - quality of life, VAS measure: Health economy: Within-trial cost-effectiveness analysis - costs measure: Health economy: Within-trial cost-effectiveness analysis - QALY measure: Health economy: Model-based cost-effectiveness analysis - QALY measure: Health economy: Model-based cost-effectiveness analysis - healthcare costs measure: Health economy: Model-based cost-effectiveness analysis - cost effectiveness ratios measure: Long-term effects - mortality and major cardiovascular disease (CVD) measure: Long-term effects - prescription patterns measure: Long-term effects - incident cancer measure: Long-term effects - fracture risk measure: Long-term effects - health economic and labour market attachment, employment status measure: Long-term effects - health economic and labour market attachment, salary measure: Long-term effects - health economic and labour market attachment, absence measure: Long-term effects - health economic and labour market attachment, sick leave measure: Long-term effects - health economic and labour market attachment, long-term sick leave sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet status: NOT_YET_RECRUITING city: Frederiksberg zip: 2000 country: Denmark name: Addie J Frederiksen role: CONTACT lat: 55.67938 lon: 12.53463 facility: The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg status: NOT_YET_RECRUITING city: Frederiksberg zip: 2000 country: Denmark name: Sofus C Larsen role: CONTACT lat: 55.67938 lon: 12.53463 facility: Hvidovre kommune: Center for Sundhed og Ældre, Hvidovre Sundhedscenter, Sundhed og Forebyggelse status: NOT_YET_RECRUITING city: Hvidovre zip: 2650 country: Denmark name: Maria Bleiback Clausen role: CONTACT lat: 55.65719 lon: 12.47364 facility: The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre status: RECRUITING city: Hvidovre zip: 2650 country: Denmark name: Carsten Dirksen role: CONTACT lat: 55.65719 lon: 12.47364 facility: Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering status: NOT_YET_RECRUITING city: Søborg zip: 2860 country: Denmark name: Julie Borgen Braget role: CONTACT lat: 56.08481 lon: 12.31803 facility: IHR CRN: Thames Valley and South Midlands status: NOT_YET_RECRUITING city: Oxford country: United Kingdom name: Susan Jebb role: CONTACT lat: 51.75222 lon: -1.25596 hasResults: False

 nctId: NCT06321445 id: ChatGptASAscore briefTitle: The Success of ChatGPT in Providing American Society of Anesthesiologist (ASA) Scores acronym: ASA overallStatus: RECRUITING date: 2024-02-08 date: 2024-04-01 date: 2024-05-01 date: 2024-03-20 date: 2024-03-22 name: Kanuni Sultan Suleyman Training and Research Hospital class: OTHER briefSummary: Patients applied to the anesthesia clinics of Health Science University Istanbul Kanuni Sultan Suleyman Training and Research Hospital and Basaksehir Cam and Sakura City Hospital were included in the study. Evaluation forms which will be filled in every preoperative examinations will be saved in the hospitals systems. Patients datas without indentification informations will be asked to ChatGpt to give anesthesiological risc scores. This scores will be compared with the scores already given by anesthesiologists. conditions: Artificial Intelligence conditions: Preoperative Evaluation studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: providing ASA score measure: The Success of ChatGPT in Providing American Society of Anesthesiologist (ASA) Scores measure: The Success of ChatGPT in clinical decisions sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital status: RECRUITING city: Istanbul zip: 34303 country: Turkey name: Engin ihsan Turan role: CONTACT phone: 05382431114 email: enginihsan@hotmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06321432 id: LightCARE briefTitle: Intensive Weight Loss Intervention Versus Usual Care for Adults With Obesity acronym: LightCARE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-12 date: 2048-12 date: 2024-03-20 date: 2024-04-26 name: Carsten Dirksen class: OTHER name: University of Copenhagen name: University of Southern Denmark name: University of Oxford name: University of Bristol name: Copenhagen Trial Unit, Center for Clinical Intervention Research briefSummary: In this trial, the aim is to assess the clinical benefits and harms, as well as cost-effectiveness of an intensive weight loss (IWL) intervention that includes total dietary replacements, behavioural support and weight-loss medication compared with existing weight management programmes within primary care for people with obesity class I or uncomplicated obesity class II or higher. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Due to the nature of the interventions, it will not be possible to blind the participants or the healthcare providers administering the interventions. In all other aspects of the trial, blinding will be employed. Outcome assessors will be blinded to group allocation. Participants will also be requested not to disclose their allocation when outcomes are assessed.

Statisticians and investigators drawing conclusions will be fully blinded. The statistical analyses will be conducted with the intervention groups coded as e.g., 'A' and 'B'. The Steering Committee ill write two abstracts while the blinding is intact; one assuming the experimental intervention group is 'A' and the control intervention group is 'B', and one assuming the opposite. After these two abstracts have both obtained consensus, the code will be broken by the data manager. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 400 type: ESTIMATED name: Intensive weight loss intervention name: Usual care measure: Weight measure: Weight loss (20%) measure: Short-Form-36, mental component score measure: Gait speed measure: MetS-Z measure: Safety - SAE measure: Safety - eating disorder measure: Safety - bone mineral density (BMD) assessed by DXA measure: Body composition - waist circumference measure: Body composition - fat percentage measure: Body composition - weight loss (10%) measure: Physical functioning - SENS measure: Physical functioning - SF-36 measure: Physical functioning - sit to stand test measure: Physical functioning - quality of life measure: Sleep measure: Medications during the intervention period measure: Metabolic health - blood pressure measure: Metabolic health - pulse measure: Metabolic health - glucose measure: Metabolic health - Hb1Ac measure: Metabolic health - insulin measure: Metabolic health - HOMA2-IR measure: Metabolic health - lipids measure: Metabolic health - eGFR measure: Metabolic health - hsCRP measure: Metabolic health - Fib4 measure: Metabolic health - Proteinuria measure: Metabolic health - TSH measure: Mental health - MDI measure: Mental health - WBIS-M measure: Mental health - EDE-Q measure: Labour market attachment - WPAI measure: Labour market attachment - days of sick leave measure: Genetic profiles' (using comprehensive genetic mapping) association with the metabolic and/or weight loss response to IWL vs usual care measure: Health economy: Within-trial cost-effectiveness analysis - quality of life measure: Health economy: Within-trial cost-effectiveness analysis - costs measure: Health economy: Within-trial cost-effectiveness analysis - QALY measure: Health economy: Model-based cost-effectiveness analysis - QALY measure: Health economy: Model-based cost-effectiveness analysis - healthcare costs measure: Health economy: Model-based cost-effectiveness analysis - cost effectiveness ratios measure: Long-term effects - mortality and major cardiovascular disease (CVD) measure: Long-term effects - prescription patterns measure: Long-term effects - incident cancer measure: Long-term effects - fracture risk measure: Long-term effects - health economic and labour market attachment, employment status measure: Long-term effects - health economic and labour market attachment, salary measure: Long-term effects - health economic and labour market attachment, absence measure: Long-term effects - health economic and labour market attachment, sick leave measure: Long-term effects - health economic and labour market attachment, long-term sick leave sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre city: Copenhagen zip: 2650 country: Denmark name: Carsten Dirksen role: CONTACT lat: 55.67594 lon: 12.56553 facility: Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet city: Frederiksberg zip: 2000 country: Denmark name: Addie J Frederiksen role: CONTACT lat: 55.67938 lon: 12.53463 facility: The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg city: Frederiksberg zip: 2000 country: Denmark name: Sofus C Larsen role: CONTACT lat: 55.67938 lon: 12.53463 facility: Hvidovre kommune: Center for Sundhed og Ældre, Hvidovre Sundhedscenter, Sundhed og Forebyggelse city: Hvidovre zip: 2650 country: Denmark name: Maria Bleiback Clausen role: CONTACT lat: 55.65719 lon: 12.47364 facility: Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering city: Søborg zip: 2860 country: Denmark name: Julie Borgen Braget role: CONTACT lat: 56.08481 lon: 12.31803 facility: NIHR CRN: Thames Valley and South Midlands city: Oxford country: United Kingdom name: Paul Aveyard role: CONTACT lat: 51.75222 lon: -1.25596 hasResults: False

 nctId: NCT06321419 id: atls-vs-standard-care briefTitle: ATLS vs Standard Care Trial overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2029-11 date: 2029-11 date: 2024-03-20 date: 2024-04-25 name: Karolinska Institutet class: OTHER name: The George Institute for Global Health, India briefSummary: Rationale:

Trauma is a massive global health issue. Many training programmes have been developed to help physicians in the initial management of trauma patients. Among these programmes, Advanced Trauma Life Support® (ATLS®) is the most popular, having trained over one million physicians worldwide. Despite its widespread use, there are no controlled trials showing that ATLS® improves patient outcomes. Multiple systematic reviews emphasise the need for such trials.

Aim:

To compare the effects of ATLS® training with standard care on outcomes in adult trauma patients.

Trial Population:

Adult trauma patients presenting to the emergency department of a participating hospital.

Eligibility Criteria:

Hospitals are secondary or tertiary hospitals in India that admit or refer/transfer for admission at least 400 patients with trauma per year. Clusters are one or more units of physicians providing initial trauma care in the emergency department of tertiary hospitals in India. Patients participants are adult trauma patients who presents to the emergency department of participating hospitals and are admitted or transferred for admission.

Ethical Considerations:

The study will use an opt-out consent approach for in-hospital collection of routinely recorded data, in which consent is presumed unless actively declined. Informed consent for non-routinely recorded data including out of hospital follow up will be obtained. Patients who are unconscious or lack a legally authorized representative will be included under a waiver of informed consent. Note that consent here refers to consent to data collection, as it will not be possible for patients to opt out from being subjected to the intervention. This approach is justified because the trial can be considered to involve only minimal risk and the data collection is non-invasive and mostly involve extracting routinely collected data from medical records.

Funding:

Swedish Research Council (reg. no. 2023-03128), Laerdal Foundation (reg. no. 2023-0297).

Special considerations:

This trial is not yet fully funded. The Trial Management Group has decided to proceed with the trial with the expectation that additional funding will be secured. The Joint Trial Steering and Data Monitoring Committee will be informed of the funding status at each meeting. If funding is not secured, the trial will be stopped. This will likely result in an underpowered trial. The justification for this decision is that the intervention is considered standard of care in many countries and the data collection is considered minimal risk. There is therefore a very small risk of harm to patient participants, but a potential direct benefit to those. conditions: Wounds and Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Batched stepped-wedge cluster randomised trial. We will roll out the interventions to 30 clusters over six batches, so there will be five clusters in each batch. The clusters in each batch will be randomised to one of five implementation sequences, with one hospital randomised to each implementation sequence. All clusters will transition through three phases, first a standard care phase, then a one month transition phase during which the training is delivered, and finally an intervention phase, for a total of 13 months. primaryPurpose: TREATMENT masking: NONE count: 4320 type: ESTIMATED name: Advanced Trauma Life Support training measure: All-cause mortality within 30 days of arrival at the emergency department. sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06321406 id: KayseriCHdysphagia briefTitle: Effect of Superficial Neuromuscular Stimulation in Post-stroke Dysphagic Patients. overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-06-15 date: 2024-07-15 date: 2024-03-20 date: 2024-03-27 name: Kayseri City Hospital class: OTHER_GOV briefSummary: Swallowing disorder in stroke patients is a significant cause of morbidity and mortality as it can cause aspiration pneumonia. Electrical stimulation has proven to be effective in post-stroke dysphagic patients.10 patients who have symptoms of post-stroke dysphagia, meet the inclusion criteria and volunteer to participate will be included in the study. Included patients will be randomized into 2 groups. The exercise program will be applied to both groups as a home program for 4 weeks. conditions: Dysphagia conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: NMES (neuromuscular electrical stimulation) name: Exercise measure: Ultrasonographic measurements measure: Functional Oral Intake Scale (FOIS) measure: Swallowing Function Screening Test (EAT-10) measure: GUSS (Gagging Swallowing Screening Test) measure: Modified Mann Swallowing Ability Assessment Test (MMASA) measure: SWAL-QOL (The impact of swallowing disorders on quality of life questionnaire) sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: health sciences university Kayseri medicine faculty city: Kayseri zip: 38080 country: Turkey lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06321393 id: HE662176 briefTitle: Effects of a CSE With ADIM in Chronic Non-specific Low Back Pain With Lumbar Instability Using Telerehabilitation. overallStatus: RECRUITING date: 2024-02-01 date: 2024-10-31 date: 2024-12-31 date: 2024-03-20 date: 2024-04-02 name: Khon Kaen University class: OTHER briefSummary: The goal of this clinical trial is to compare the effectiveness of telerehabilitation-based and clinic-based methods to deliver a Core Stabilization Exercise Program with the Abdominal Drawing-In Maneuver Technique (CSE with ADIM) on pain intensity, functional ability, quality of life, and satisfaction in chronic low back pain patients with lumbar instability.

The main question it aims to answer is: Is there a difference between the effectiveness of telerehabilitation-based and clinic-based CSE with ADIM on pain intensity, functional ability, quality of life, and satisfaction in chronic low back pain patients with lumbar instability?

Participants will perform a 7-week core stabilization exercise with the abdominal drawing-in maneuver technique, consisting of an exercise program for 20-minute sessions with 3 sessions per week. These exercise programs will be provided to the participants via a weekly video call with the main researcher as a telerehabilitation program. At the first session of each week, the researcher will provide supervision via video call with the participant for the exercise program. The participants will perform the exercise by following the video demonstration. After completing weekly training, participants will perform their exercise routine as part of their daily home program.

If there is a comparison group: researchers will compare The control group (clinical-base group) will be provided the 7-week core stabilization exercise with abdominal drawing-in maneuver technique, the same as the experimental group, but control groups received the exercise program at the clinic according to the usual methods. At the first session of each week, an appointment will be set, and then the specific exercise for each week will be delivered and trained by the main researcher at the clinic. After completing weekly training, participants will perform their exercise routine as part of their daily home program to see if there are any differences in pain intensity, functional ability, quality of life, and satisfaction in chronic low back pain patients with lumbar instability between the experimental and control groups. conditions: Chronic Low-back Pain conditions: Lumbar Instability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: 7-week Core stabilization exercise with abdominal drawing-in maneuver technique measure: 11-ponits Numerical Rating Scale (0-10 NRS) measure: Oswestry disability index (ODI) measure: Roland Morris Disability Questionnaire (RMDQ) measure: 36-item Short Form Survey (SF-36) measure: Lumbar joint reposition sense error measure: Satisfaction questionnaire sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Miss Chutimon Kongsa status: RECRUITING city: Maha Sarakham state: Mahasarakham zip: 44000 country: Thailand name: Chutimon Kongsa role: CONTACT phone: +66852736773 email: chutimon.ko@kkumail.com name: Torkamol Hunsawong role: CONTACT phone: 043202399 email: tkmhun@kku.ac.th lat: 16.18483 lon: 103.30067 hasResults: False

 nctId: NCT06321380 id: 38RC23.0381 briefTitle: Working Memory Functioning in Alzheimer's Disease and Vascular Dementia acronym: MEMTRAV-COG overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-09 date: 2025-10 date: 2024-03-20 date: 2024-03-20 name: University Hospital, Grenoble class: OTHER name: University Grenoble Alps name: Université Savoie Mont Blanc name: Centre National de la Recherche Scientifique, France name: Laboratoire de Psychologie et NeuroCognition briefSummary: The aim of the present study is to investigate potential cognitive mechanisms contributing to working memory impairment in Alzheimer's disease and vascular dementia. The investigators consider a new hypothesis suggesting that difficulties in mobilizing maintenance strategies of information could explain this working memory deficit. More specifically, the investigators assume that patient groups will have difficulties in employing both refreshing and elaborative strategies during a working memory task (i.e., complex span task), as compared to a control group. conditions: Alzheimer Disease conditions: Vascular Dementia conditions: Mixed Dementias studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Complex span task name: Clinical neuropsychological assessment name: Clinical neurospychological assessement measure: Memory performance in the Working memory task measure: Processing performance in the Working memory task measure: Reaction time measure: Mini-Mental State Examination (MMSE) measure: Digit span forward WAIS IV (digit number) measure: Digit span forward WAIS IV (standard note) measure: Digit span backward WAIS IV (digit number) measure: Digit span backward WAIS IV (standard note) measure: Stroop Test - denomination part measure: Stroop Test - minor interference part (Time) measure: Stroop Test - minor interference part (errors) measure: Stroop Test - major interference part (time) measure: Stroop Test - major interference part (errors) measure: Trail Making Test - Part A (time) measure: Trail Making Test - Part A (errors) measure: Trail Making Test - Part B (time) measure: Trail Making Test - Part B (errors) measure: Category fluences measure: Memory evaluation (16-item Free and Cued Recall, or GERIA-12) measure: Naming task measure: Behavior rating inventory of executive function measure: Instrumental Activities of Daily Living measure: Activities of Daily Living sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06321367 id: 202401002 id: 82070613 type: OTHER_GRANT domain: the National Natural Sciences Foundation of China id: 82370638 type: OTHER_GRANT domain: the National Natural Sciences Foundation of China id: 2022RC1212 type: OTHER_GRANT domain: the Science and Technology Innovation Program of Hunan Province id: 2023JJ10095 type: OTHER_GRANT domain: he Natural Science Foundation of Hunan Province China briefTitle: Model to Predict Coinfection in Elderly Patients With COVID-19 overallStatus: COMPLETED date: 2022-12-20 date: 2023-06-30 date: 2023-06-30 date: 2024-03-20 date: 2024-03-21 name: Xiangya Hospital of Central South University class: OTHER briefSummary: The goal of this observational study is to learn about the clinical characteristics and construction of a predictive model in elderly COVID-19 patients. The main question it aims to answer is the main clinical characteristics and risk factors of elderly COVID-19 patients. Participants will not be asked to do any other intervening measure. conditions: Covid19 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ACTUAL measure: Coinfection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xiangya Hospital of Central South University city: Changsha state: Hunan zip: 410000 country: China lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06321354 id: KY 2018-066-02-3 briefTitle: Pre-emptive Infiltration of the Scalp With Diprospan Plus Ropivacaine for Pain After Craniotomy in Children overallStatus: RECRUITING date: 2024-03-20 date: 2024-10-18 date: 2024-11-02 date: 2024-03-20 date: 2024-04-02 name: Beijing Tiantan Hospital class: OTHER name: Beijing Children's Hospital briefSummary: At present, pediatric postoperative analgesia has not been fully understood and controlled, particularly craniotomy surgery. On the one hand, professional evaluation of postoperative pain for young children is difficult; on the other hand, the particularity of craniotomy adds (such as consciousness obstacle, sleepiness, et al) disturbance to the pain assessment in children. Although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management, it may be associated with delayed awakening, respiratory depression, hypercarbia and it may interfere with the neurologic examination. For the avoidance of side-effects of systemic opioids, local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was unsatisfactory due to its short pain relief duration, steroid as adjuvant can enhance postoperative analgesia and prolong postoperative analgesia time. As is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles, preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction. Researchers have clarified that the addition of diprospan to local infiltration of analgesia could provide significant analgesic effects and significantly prolong the duration of analgesic effects without obvious complications for various types of surgeries. To date, no studies have evaluated the addition of diprospan to local infiltration for patients receiving craniotomy.

Thus, investigators suppose that pre-emptive scalp infiltration with steroid (Diprospan) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children. conditions: Pain conditions: Postoperative Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 108 type: ESTIMATED name: The diprospan plus ropivacaine group name: The ropivacaine group measure: modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS) measure: modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS) measure: The time to the first rescue analgesic measure: Patient satisfactory scale (PSS) measure: Length of stay (LOS) measure: The occurrence of postoperative nausea and vomiting (PONV) measure: Ramsay Sedation Scale (RSS) measure: The occurrence of respiratory depression measure: Heart rate measure: Mean arterial pressure measure: The total consumption of opioids during the operation measure: The total consumption of anaesthetic during the operation measure: Wound Healing Score measure: Incisional related adverse events measure: The occurrence of the Adverse events (AEs) and serious adverse events (SAEs) sex: ALL minimumAge: 2 Years maximumAge: 12 Years stdAges: CHILD facility: Beijing Children's hospital affiliated to capital medical university status: RECRUITING city: Beijing state: Beijing zip: 100045 country: China name: Ge Ming, M.D role: CONTACT phone: 010-59616408 email: geming88@126.com lat: 39.9075 lon: 116.39723 facility: Beijing Tiantan Hospital status: RECRUITING city: Beijing state: Beijing zip: 100070 country: China name: Luo Fang, M.D role: CONTACT phone: +86 13611326978 email: 13611326978@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06321341 id: BUSP-04-04-2023 briefTitle: Efficacy and Safety of Vespireit, Sustained-release Tablets, in Patients With Autonomic Dysfunction Syndrome Accompanied by Functional Vertigo overallStatus: RECRUITING date: 2024-01-24 date: 2026-12-31 date: 2026-12-31 date: 2024-03-20 date: 2024-03-20 name: Valenta Pharm JSC class: INDUSTRY briefSummary: Study of efficacy and safety of Vespireit, prolonged-release tablets, 15 mg (Valenta Pharm JSC, Russia) in comparison with Arlevert, tablets, 40 mg + 20 mg (Menarini International Operations Luxembourg S.A., Luxembourg) in patients with autonomic dysfunction syndrome accompanied by functional vertigo. conditions: Vertigo conditions: Autonomic Dysfunction studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 160 type: ESTIMATED name: Vespireit name: Arlevert measure: Change in Mean vertigo score (MVS) at Visit 1-3 of the Primary Therapy Period relative to baseline at Visit 1-1 measure: Change in mean MVS score at Visit 1-2 of the Primary Therapy Period relative to baseline at Visit 1-1. measure: Change in mean MVS score at Visits 2-2, 2-3, and 2-4 of the Retreatment Period compared with Visit 2-1. measure: Change in mean MVS score at the visit of completion of study participation compared with the score at Visit 1-1 in patients who completed the study according to the protocol (PP(response)). measure: Percentage of patients with a ≥50% reduction in total DHI score on Visit 1-3 of the Primary Therapy Period relative to Visit 1-1. measure: Percentage of patients with a ≥50% reduction in total DHI score on Visits 2-3 and 2-4 of the Retreatment Period relative to Visit 2-1. measure: Percentage of patients with a ≥25% reduction in total DHI score on Visit 1-3 of the Primary Therapy Period relative to Visit 1-1. measure: Percentage of patients with a ≥25% reduction in total DHI score on Visits 2-3 and 2-4 of the Retreatment Period relative to Visit 2-1. measure: Change in total score on the DHI at Visit 1-3 of the Primary Therapy Period compared with Visit 1-1. measure: Change in total score on the DHI at Visits 2-3 and 2-4 of the Retreatment Period compared with Visit 2-1. measure: Change in total score on the DHI at the study participation completion visit compared to the score at Visit 1-1 in patients who completed the study according to the protocol (PP(response)). measure: Change in digital rating scalescore from Visit 1-1 to Visits 1-2 and 1-3 in the Primary Treatment Period. measure: Change in digital rating scale score from Visit 2-1 to Visits 2-2, 2-3, and 2-4 in the Retreatment Period. measure: Assessment of quality of life in patients with autonomic dysfunction syndrome accompanied by functional vertigo using the EQ-5D questionnaire at Visit 1-3 of the Primary Therapy Period. measure: Assessment of quality of life in patients with autonomic dysfunction syndrome accompanied by functional vertigo using the EQ-5D questionnaire at Visits 2-3 and 2-4 of the Retreatment Period. measure: Change in total score on the Hamilton Anxiety Rating Scale HARS at Visit 1-3 of the Primary Treatment Period compared with Visit 1-1. measure: Change in total score on the Hamilton Anxiety Rating Scale HARS at Visits 2-3 and 2-4 of the Retreatment Period compared with Visit 2-1. measure: Change in VSS-SF total score at Visit 1-3 of the Primary Therapy Period relative to baseline at Visit 1-1. measure: Change in VSS-SF total score at Visits 2- 3 and 2-4 of the Retreatment Period compared with Visit 2-1. measure: Change in VSS-SF total score at the study participation completion visit compared with the score at Visit 1-1 in patients who completed the study according to protocol (PP(response)). measure: Evaluation of therapy efficacy on the CGI-i scale by the patient at Visits 1-2 and 1-3 in the Primary Therapy Period. measure: Evaluation of therapy efficacy on the CGI-i scale by the physician at Visits 1-2 and 1-3 in the Primary Therapy Period. measure: Evaluation of therapy efficacy on the CGI-i scale by the patient at Visits 2-2, 2-3, and 2-4 in the Retreatment Period. measure: Evaluation of the effectiveness of therapy on the CGI-i scale by the physician at Visits 2-2, 2-3, 2-4 in the Re-Treatment Period. measure: Proportion of patients with exacerbation (relapse) of the disease after treatment in the Primary Treatment Period during the entire follow-up period (until the visit of completion of participation in the study) measure: Duration of remission period after treatment in the Primary Therapy Period. Remission means absence of episodes of exacerbations (relapses) measure: Clinically significant abnormalities on physical and/or neurologic examination measure: Adverse events (AEs) measure: Serious adverse events (SAEs) measure: Adverse reactions measure: Рatients with at least one AE measure: Patients discontinued due to AE sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Central Clinic LLC status: RECRUITING city: Bryansk zip: 241050 country: Russian Federation name: Marina A Agafonova, MD, PhD role: CONTACT phone: +7-4832-72-58-28 email: agafonova.marina.sm@mail.ru lat: 53.25209 lon: 34.37167 facility: Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Healthcare of the Russian Federation status: RECRUITING city: Kirov zip: 610027 country: Russian Federation name: Nadezhda S Trushnikova, MD role: CONTACT phone: +7-8332-62-75-68 email: uddefola@mail.ru lat: 58.59665 lon: 49.66007 facility: State Budgetary Institution of Healthcare of the City of Moscow "V.P. Demikhov City Clinical Hospital of the Department of Healthcare of the City of Moscow" status: RECRUITING city: Moscow zip: 109263 country: Russian Federation name: Kamila B Gadjialieva, MD role: CONTACT phone: +7-925-710-00-97 email: demikhovadzm@mail.ru lat: 55.75222 lon: 37.61556 facility: Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of the city of Smolensk" status: RECRUITING city: Smolensk zip: 214025 country: Russian Federation name: Natalia A Belyaeva, MD role: CONTACT phone: +7-4812-24-50-60 email: n.makar1973@mail.ru lat: 54.7818 lon: 32.0401 hasResults: False

 nctId: NCT06321328 id: ChatGpt postoperative ICU briefTitle: Success of ChatGPT in Determining the Need for Postoperative Intensive Care overallStatus: NOT_YET_RECRUITING date: 2024-03-16 date: 2024-04-16 date: 2024-05-01 date: 2024-03-20 date: 2024-03-20 name: Kanuni Sultan Suleyman Training and Research Hospital class: OTHER briefSummary: This is a prospective, observational study to be conducted at Sağlık Bilimleri University Istanbul Kanuni Sultan Süleyman Training and Research Hospital and Başakşehir Çam and Sakura City Hospital. The study aims to record various preoperative and postoperative data of patients who have undergone surgeries, specifically those with ASA scores of III and IV or those indicated to potentially need postoperative intensive care. Data points include patient demographics, type of surgery, ASA score, comorbidities, lab and imaging findings, and both actual and ChatGPT version 4 predicted outcomes regarding postoperative intensive care needs, anesthesia methods, duration of stay in intensive care and the hospital, and 30-day mortality rates. ChatGPT version 4's predictions will be compared with actual outcomes and anesthesiologist decisions. conditions: Artificial Intelligence conditions: Intensive Care Unit conditions: PACU Length of Stay studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 398 type: ESTIMATED measure: Intensive care predictions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: istanbul Kanuni Sultan Süleyman Education and Training Hospital city: Istanbul zip: 34303 country: Turkey name: Yeşim Özay role: CONTACT phone: 0090212 404 15 00 phoneExt: 2144 lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06321315 id: KSUESRAKARATASOKYAY006 briefTitle: The Effect of Case-based Teaching on Midwifery Undergraduate Students overallStatus: RECRUITING date: 2024-03-19 date: 2024-04-30 date: 2024-04-30 date: 2024-03-20 date: 2024-04-05 name: Kahramanmaras Sutcu Imam University class: OTHER briefSummary: Case-based teaching will be applied to second year midwifery undergraduate students. The intervention group (case-based teaching implementation group) and the control group each consist of 35 students. conditions: Midwifery Students studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention group (Case-based instruction group) Control group primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 70 type: ESTIMATED name: Case-based instruction measure: Determination of Critical Thinking Motivation measure: Determination of Critical Thinking Motivation measure: Determining the level of Academic Motivation measure: Determining the level of Academic Motivation measure: Determining the status of access to information measure: Determining the status of access to information measure: Evaluation of satisfaction with the training methods used and the effect of training methods on perceptions of competence during clinical practice measure: Evaluation of satisfaction with the training methods used and the effect of training methods on perceptions of competence during clinical practice sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Kahramanmaras Sutcu Imam University status: RECRUITING city: Kahramanmaraş state: Kahramanmaras zip: 46050 country: Turkey name: Esra KARATAŞ OKYAY, PhD role: CONTACT phone: 05432125225 email: esrakaratas44@hotmail.com name: Pınar KARA, PhD role: CONTACT phone: 0507 957 0859 email: karapinar@hotmail.com lat: 37.5847 lon: 36.92641 hasResults: False

 nctId: NCT06321302 id: 1436-0007 id: 2023-508891-12-00 type: REGISTRY domain: CTIS id: U1111-1299-0915 type: REGISTRY domain: Universal Trial Number briefTitle: A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy overallStatus: NOT_YET_RECRUITING date: 2024-05-08 date: 2026-07-01 date: 2026-11-11 date: 2024-03-20 date: 2024-03-27 name: Boehringer Ingelheim class: INDUSTRY briefSummary: This study is open to adults with diabetic retinopathy. People who have non-proliferative diabetic retinopathy of moderate or high severity can join the study.

The purpose of this study is to find out whether a medicine called BI 764524 helps people with diabetic retinopathy. The study also aims to find a suitable treatment plan for BI 764524. Participants are put into 5 groups by chance. Participants in groups 1, 2, and 3 get BI 764524. Over 1 year, they get a different number of injections of the same dose of BI 764524 injected into 1 eye. During some visits, participants may get a sham control, which is done like an eye injection but without a needle, so that participants will not know how many injections of BI 764524 they received. Participants in group 4 only get a sham control. Participants in group 5 (only in the USA) get aflibercept or sham injections during some visits. Aflibercept is a medicine already used to treat diabetic retinopathy.

Participants are in the study for one and a half years. During this time, they visit the study site at least 16 times. During this time, doctors regularly do eye exams and visual tests to assess the severity of participants' eye condition. After 1 year of treatment, researchers look at the number of participants with eye improvements. To do so, they compare eye damage and certain severe eye problems between the groups of participants. The doctors also regularly check participants' health and take note of any unwanted effects. conditions: Diabetic Retinopathy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 175 type: ESTIMATED name: BI 764524 name: Sham comparator to BI 764524 name: Aflibercept (Eylea®) - US only measure: Occurrence of a ≥2-step improvement compared with baseline in Diabetic Retinopathy Severity Scale (DRSS) level in the study eye at Week 52 measure: Occurrence of vision threatening complications (VTC)s in the study eye between baseline and Week 52 measure: Absolute change from baseline of best corrected visual acuity (BCVA) [early treatment diabetic retinopathy study (ETDRS) letters] in the study eye at Week 52 measure: Absolute change from baseline of central retinal thickness [μm], as assessed by spectral domain optical coherence tomography (SD-OCT), in the study eye at Week 52 measure: Occurrence of a ≥2-step worsening of Diabetic Retinopathy Severity Scale (DRSS) in the study eye between baseline and Week 52 measure: Occurrence of proliferative diabetic retinopathy (PDR) and/or anterior segment neovascularisation (NV) in the study eye between baseline and Week 52 measure: Occurrence of centre-involved diabetic macular edema (CI-DME) in the study eye between baseline and Week 52 measure: Occurrence of drug-related adverse events (AEs) between baseline and end of study (EOS) measure: Occurrence of ocular AEs in the study eye between baseline and EOS measure: Occurrence of ocular AEs of special interest in the study eye between baseline and EOS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06321289 id: CHN-PLAGH-BT-084 briefTitle: Allogeneic TRAC Locus-inserted CD19-targeting STAR T Cell Therapy in r/r B-NHL overallStatus: RECRUITING date: 2024-03-20 date: 2026-03-20 date: 2027-03-20 date: 2024-03-20 date: 2024-03-25 name: Chinese PLA General Hospital class: OTHER briefSummary: The team has developed the synthetic T cell receptor (TCR) and antigen receptor (STAR) T cells which were demonstrated safety in relapsed or refractory (r/r) B-cell non-Hodgkin' s lymphoma (B-NHL) (NCT05631912). Based on this research, allogeneic STAR-T cell products utilized the CRISPR-Cas9 gene editing tool to knock out endogenous receptor α constant (TRAC), human leukocyte antigen (HLA)-A/B, CIITA, and programmed death 1 (PD-1) genes simultaneously in T cells from healthy donors, and integrated the STAR molecule into the TRAC locus using adenovirus associated virus. This strategy can reduce graft-versus-host-disease (GvHD) toxicity and host-versus-graft response, decrease the sensitivity of STAR T cells to immunosuppressive signals, and improve their anti-tumor activity. In this single center, prospective, open-label, single-arm, phase 1/2 study, the safety and efficacy of allogeneic CD19-targeting STAR T cell therapy will be evaluated in patients with r/r B-NHL. conditions: Non-hodgkin Lymphoma,B Cell studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Allogeneic CD19-STAR T cell name: Fludarabine name: Cyclophosphamide measure: Phase 1: Incidence of Adverse Events (AEs) defined as DLT measure: Phase 1: RP2D measure: Phase 2: Best objective Response Rate measure: Phase 2: Overall Survival (OS) measure: Phase 2: Progression Free Survival (PFS) measure: Phase 2: Time to response (TTR) measure: Phase 2: Duration of Response (DOR) measure: Pharmacokinetics: Number and copy number of CD19-STAR T cells (phase 1 and phase 2) measure: Pharmacokinetics: Persistence of CD19-STAR T (phase 1 and phase 2) measure: Pharmacodynamics: Peak level of cytokines in serum (phase 1 and phase 2) measure: Phase 1: Levels of donor-specific anti-HLA antibodies (DSA) in blood. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Biotherapeutic Department of Chinese PLA General Hospital status: RECRUITING city: Beijing state: Beijing zip: 100853 country: China name: Weidong Han, M.D role: CONTACT phone: +86-010-66937463 email: hanwdrsw@sina.com name: Qingming Yang, M.D role: SUB_INVESTIGATOR name: Yang Liu, M.D role: SUB_INVESTIGATOR name: Jinhong Shi, M.S role: SUB_INVESTIGATOR name: Chunmeng Wang, M.S role: SUB_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: School of medicine, Tsinghua University & Changping Laboratory status: RECRUITING city: Beijing country: China name: Xin Lin, Ph.D role: CONTACT phone: +86-010-62796319 email: linxin307@mail.tsinghua.edu.cn name: Xin Lin, Ph.D role: SUB_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06321276 id: AEU-FTR-ID-01 briefTitle: Investigation of the Efficiency of Radial Extracorporeal Shock Wave Therapy at Different Pulses in Carpal Tunnel Syndrome overallStatus: RECRUITING date: 2024-03-18 date: 2024-04-15 date: 2024-06-01 date: 2024-03-20 date: 2024-03-20 name: Ahi Evran University Education and Research Hospital class: OTHER briefSummary: Different parameters have been used in studies investigating the efficacy of extracorporeal shock wave therapy in the treatment of carpal tunnel syndrome. Although extracorporeal shock wave therapy has been shown to have a positive effect on carpal tunnel syndrome, there is no consensus on which pulse rate is more effective. Therefore, in this study, the efficacy of extracorporeal shock wave therapy applied at different pulse rates in the treatment of carpal tunnel syndrome will be examined. conditions: Carpal Tunnel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: three groups with a conventional therapy control group primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Patient whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: extracorporeal shockwave therapy measure: Visual analogue scale (VAS) measure: Boston Carpal Tunnel Syndrome Questionnaire measure: Hand grip strength measurement measure: Electromyoneurography (EMNG) measure: Ultrasonography sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kirsehir Ahi Evran University status: RECRUITING city: Kırşehir zip: 40100 country: Turkey name: ibrahim Doğru, MD role: CONTACT phone: 5353127880 phoneExt: +90 email: www.skillcraft@hotmail.com name: ismail ceylan, PhD role: CONTACT phone: 5364634679 phoneExt: +90 email: fztceylan@gmail.com lat: 39.14583 lon: 34.16389 hasResults: False

 nctId: NCT06321263 id: 798307 briefTitle: Comparison of the Effects of Peripheral Muscle Training and Inspiratory Muscle Training in Geriatric Individuals overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-09-27 date: 2025-03-21 date: 2024-03-20 date: 2024-03-29 name: Biruni University class: OTHER briefSummary: In geriatric individuals, there is a decrease in muscle strength, muscle mass and physical performance with ageing. These physiological changes occurring in geriatric individuals make maintaining the physical activity necessary for a healthy life difficult. Weakness of respiratory muscles in geriatric individuals can increase the prevalence of diseases and disability. It has been shown in the literature that peripheral muscle training and inspiratory muscle training increase exercise capacity similarly. The effectiveness of moderate-intensity peripheral muscle training and inspiratory muscle training in sarcopenic geriatric individuals was compared and found to have similar effects on muscle strength.

Our study aims to compare the effects of inspiratory and peripheral muscle training in addition to aerobic exercise on muscle strength, physical performance, respiratory muscle strength, functional capacity, sarcopenia, and quality of life. conditions: Muscle Strength studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Peripheral Muscle Training and step aerobics training name: Inspiratory Muscle Training and step aerobics training measure: The sociodemographic data form measure: Hand grip strength measure: Maximal inspiratory and expiratory pressures (MIP, MEP) measure: 6-Minute Walk Test (6MWT) measure: The Short Physical Performance Battery (SPPB) measure: Assessment of seniors᾽ quality of life: WHOQOL-OLD questionnaire measure: SARC-F questionnaire measure: Canadian Occupational Performance Measure sex: ALL minimumAge: 65 Years maximumAge: 80 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06321250 id: JY-JM3948-101 briefTitle: A Study of JMKX003948 Tablets in Patients With Renal Cell Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-03-28 date: 2026-05-31 date: 2027-04-30 date: 2024-03-20 date: 2024-03-20 name: Jemincare class: INDUSTRY name: Zhejiang Hangyu Pharmaceutical Co., Ltd briefSummary: This open-label Phase 1 study will evaluate the safety, tolerability, PK characteristics and preliminarily efficacy of JMKX003948 tablets in patients with renal cell carcinoma. conditions: Renal Cell Carcinoma Metastatic studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: JMKX003948 measure: Dose Escalation: Number of participants with dose limiting toxicities (DLTs) measure: Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) measure: Dose Expansion: Objective Response Rate (ORR) measure: maximum plasma concentration (Cmax) measure: maximum plasma concentration (Tmax) measure: Duration of Response (DoR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06321237 id: TJ-IRB202402130 briefTitle: Influence of Ear Vagus Nerve Stimulator on Patients With IBS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-26 date: 2024-06-09 date: 2024-03-20 date: 2024-03-20 name: Huaping Xie class: OTHER briefSummary: Irritable bowel syndrome (IBS) is a very common functional digestive disorder characterized by chronic abdominal pain and altered bowel habits in the absence of biological or structural abnormalities. In the field of IBS, effective drug treatments are very limited, and patients are urgently looking for alternatives, including probiotics, hypnotherapy, osteopathy, dietary changes, and fecal microbiota transplants. In recent years, with the continuous elucidation of vagus nerve mechanisms, IBS patients are increasingly interested in bioelectrical regulation, and these patients are often skeptical of traditional drug treatment and believe that drugs are prone to side effects. For several reasons, vagus nerve stimulation (VNS) may be a promising option for improving IBS symptoms. In this experiment, the portable ear nail stimulator produced by Ruishen Medical can accurately stimulate the ear nail, transdermal stimulation of the ear vagus nerve, and give full play to its therapeutic effect. Therefore, the purpose of this clinical trial is to use ear nail stimulator in patients with IBS to explore whether it has therapeutic effects on patients with IBS. To explore the influence of tVNS therapy on irritable bowel syndrome compared with drug therapy, it is hoped that the use of TVNS therapy can reduce the use of related drugs, or even replace drugs. This study intends to recruit a group of patients with irritable bowel syndrome to use the portable ear nail stimulator, (1) to observe whether the symptoms of irritable bowel syndrome patients are improved; (2) To analyze the changes of intestinal microbes in patients with IBS; (3) Verify whether the level of intestinal inflammation is reduced and discover metabolic markers in the intestine. conditions: Irritable Bowel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Vagus nerve stimulation for 8 weeks name: Vagus nerve stimulation for the first 4 weeks name: Vagus nerve stimulation for the last 4 weeks name: Pseudostimulus measure: Changes in irritable bowel symptoms measure: Changes in the diversity of intestinal flora measure: Changes in the relative abundance of species of intestinal flora measure: Changes in the number of intestinal flora sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-07 uploadDate: 2024-03-11T05:59 filename: Prot_SAP_000.pdf size: 2489139 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-07 uploadDate: 2024-03-11T06:13 filename: ICF_001.pdf size: 273802 hasResults: False

 nctId: NCT06321224 id: 2024/03/08 briefTitle: Effects of Breathing Exercises on Women With Primary Dysmenorhea overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-05 date: 2025-03 date: 2024-03-20 date: 2024-03-20 name: Ankara Yildirim Beyazıt University class: OTHER briefSummary: The aim of this study is to examine the effects of breathing exercises in women with primary dysmenorrhea. conditions: Dysmenorrhea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: Breathing exercises name: Control measure: Menstrual pain intensity measure: Menstrual symptoms measure: Life quality measure: Stress level measure: Sleep quality sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06321211 id: RECAS-0244 briefTitle: Development of a Novel Asian Mediterranean Diet and Its Acceptability in NAFLD acronym: aMed overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-06-30 date: 2024-12-27 date: 2024-03-20 date: 2024-03-20 name: Singapore Institute of Technology class: OTHER name: Singapore Health Services briefSummary: The goal of this pre-intervention study is test the acceptability of Asian version of the Mediterranean diet to NAFLD patients.

The main question\[s\] it aims to answer are:

1. Whether Asian version of the Mediterranean diet that retains the nutritional composition and can be developed by mapping the components of the Mediterranean diet and finding substitute ingredients commonly eaten in Southeast Asia.
2. Whether the 4-week menu cycle of newly developed novel Asian Mediterranean diet is acceptable among Singaporean local population.

Participants will participate in taste test sessions to find out if the Asian Mediterranean diet meals are acceptable to people with NAFLD. conditions: Fatty Liver, Nonalcoholic studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED measure: Sensory Evaluation Test Score NAFLD sex: ALL minimumAge: 21 Years maximumAge: 60 Years stdAges: ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-02 uploadDate: 2024-02-29T00:58 filename: Prot_SAP_000.pdf size: 135277 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form: Consent Form Only date: 2024-03-02 uploadDate: 2024-03-06T09:36 filename: ICF_001.pdf size: 732118 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form: Participant Information Sheet date: 2024-03-02 uploadDate: 2024-03-13T21:38 filename: ICF_002.pdf size: 861264 hasResults: False

 nctId: NCT06321198 id: iMSC-2001 briefTitle: A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD overallStatus: RECRUITING date: 2024-02-10 date: 2027-03-02 date: 2027-03-02 date: 2024-03-20 date: 2024-03-20 name: Anhui Provincial Hospital class: OTHER_GOV briefSummary: A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD conditions: Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD) studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: iMSC measure: Dose-Limiting Toxicity(DLT) measure: Adverse Event(AE),Serious Adverse Event(SAE),Treatment Emergent Adverse Event(TEAE)and Treatment Related Adverse Event(TRAE) measure: Objective Response Rate(ORR) measure: Overall Survival(OS) sex: ALL minimumAge: 4 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Provincial Hospital status: RECRUITING city: Hefei state: Anhui zip: 230036 country: China name: Zhu Xiaoyu, Ph.D role: CONTACT phone: +86 15255456091 email: xiaoyuz@ustc.edu.cn name: Sun Guangyu role: CONTACT phone: +86 13956970687 email: sunguangyu_vip@foxmail.com lat: 31.86389 lon: 117.28083 hasResults: False

 nctId: NCT06321185 id: 2024/177 briefTitle: Laparoscopic Cholecystectomy and Quality of Recovery overallStatus: RECRUITING date: 2024-03-25 date: 2024-08-25 date: 2024-08-25 date: 2024-03-20 date: 2024-03-27 name: Istanbul University class: OTHER briefSummary: This clinical trial aims to compare the Quality of Recovery-15 (QoR-15) scale scores in three groups of patients undergoing laparoscopic cholecystectomy. The first group will be applied subcostal transversus abdominis plane (subcostal TAP) block, the second group will receive local anesthetic infiltration into port sites, and the third group will receive only IV analgesics. conditions: Laparoscopic Cholecystectomy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The patients will be allocated randomly into three groups. Two groups will receive subcostal TAP block or port site local anesthetic infiltration, and the third group will not receive any intervention. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The subcostal TAP block and port-site infiltration will be applied after the patient has general anesthesia, so the patient will not know the allocated group. The healthcare providers who work in the ward and are responsible for the analgesic treatments will be blinded to the patient's group. The outcomes assessor who will question the QoR-15 scale at the 24th hour will also be blinded. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Subcostal TAP block name: Port site local anesthetic infiltration name: No intervention or local anesthetic administration measure: Quality of Recovery-15 (QoR-15) scale measure: Postoperative rescue analgesic requirement measure: Consumption of postoperative opioid analgesics measure: Numerical Rating Scale (NRS) scores measure: Postoperative nausea and vomiting sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul University Istanbul Medical Faculty, Department of Anesthesiology and Reanimation status: RECRUITING city: Istanbul state: Fatih zip: 34093 country: Turkey name: Muserref B Dincer role: CONTACT phone: +905321624712 email: mberildincer@gmail.com name: Ahmet K Koltka role: CONTACT email: koltkak@yahoo.com name: Muserref B Dincer role: PRINCIPAL_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06321172 id: 785 briefTitle: Muscle and Bone Changes After 6 Months of FES Cycling acronym: FES-Bike overallStatus: ACTIVE_NOT_RECRUITING date: 2022-09-09 date: 2024-01-22 date: 2024-04-29 date: 2024-03-20 date: 2024-03-22 name: IRCCS Eugenio Medea class: OTHER name: Politecnico di Milano name: Villa Beretta Rehabilitation Center name: National Research Council briefSummary: The goal of this clinical trial is to assess the effectiveness of FES cycling in terms of changes morpho-functional characteristics of the leg muscles, training performance and bone trophism in 5 subjects with Spinal Cord Injury after 6 months of training. The main question\[s\] it aims to answer are:

* Do the morpho-functional characteristics of the leg muscles improve after 3 and 6 months of training with FES cycling? If any, the morpho-functional improvements are maintained one month after the end of the training?
* Does the quality of the leg bones improve after 3 and 6 months of training with FES cycling?
* Does the training performance improve during the training with FES cycling?
* Do the data referred to the vegetative nervous system change after 3 and 6 months of training with FES cycling? If yes, the changes in the vegetative nervous system are maintained one month after the end of the training?
* Does the intestinal function change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?
* Does the level of spasticity of the lower limbs change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?
* Does the level of pain perceived by pilots change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?
* Does the Psychological General Well-Being of the pilots change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?
* Does the pilots' motivation in carrying out a sporting activity change between T1 (3 months after starting the training) and T2(6 months after starting the training)?

Participants will train for 6 months with FES-cycling twice a week. Each session includes at most 30 minutes of stimulation. conditions: Spinal Cord Injuries studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ACTUAL name: FES Bike measure: Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb measure: Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb measure: Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb measure: Changes in bone quality measure: Changes in data referring to the vegetative nervous system measure: Changes in data referring to the vegetative nervous system measure: Changes in data referring to the vegetative nervous system measure: Changes in the intestinal function measure: Changes in the intestinal function measure: Changes in the intestinal function measure: Changes in the level of spasticity of the lower limbs measure: Changes in the level of spasticity of the lower limbs measure: Changes in the level of spasticity of the lower limbs measure: Changes in the level of pain perceived measure: Changes in the level of pain perceived measure: Changes in the level of pain perceived measure: Changes in the General Well Being of the pilots while training measure: Changes in the General Well Being of the pilots while training measure: Changes in the General Well Being of the pilots while training measure: Pilots' motivation in carrying out a sporting activity measure: Pilots' motivation in carrying out a sporting activity sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Scientific Institute, IRCCS E. Medea city: Bosisio Parini state: Lecco zip: 23842 country: Italy lat: 45.80075 lon: 9.29 hasResults: False

 nctId: NCT06321159 id: Nursing Dep. briefTitle: Investigation of the Effect of Mobile Software Use in Blood Pressure Management of Hypertensive Individuals on Quality of Life and Disease Self-Efficacy overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-11-30 date: 2026-01-30 date: 2024-03-20 date: 2024-03-20 name: Inonu University class: OTHER briefSummary: Hypertension is a prevalent health concern, affecting one in three adults globally, with the potential to lead to fatal complications. However, an alarming proportion of those diagnosed-four out of five individuals-struggle to effectively manage this condition. As such, the effective management of hypertension becomes paramount. A study conducted post-earthquake by a principal investigator and a scholarship recipient revealed that 47.9% of participants received a hypertension diagnosis, and a significant 67.8% ceased active management of the condition. Existing literature suggests a notable decline in the quality of life among individuals unable to manage hypertension effectively. While current research emphasizes the components of nutrition, exercise, and medication adherence in hypertension management, the integration of these components into mobile applications is notably lacking. This project seeks to enhance disease management for users by integrating crucial elements, including blood pressure measurement, into a user-friendly mobile application, thereby providing a distinctive contribution. The proposed application encompasses the recording of vital signs, integration of customized diet and exercise programs tailored for hypertension, and provision of consultancy services for identifying deviations in health status and implementing appropriate interventions. The integration of these components is anticipated to contribute to preventing or minimizing potential complications for the patient. Comprehensive studies incorporating such an approach are rarely encountered in the existing literature, enhancing the originality of this research. The project\&amp;#39;s overarching goal is to enable individuals to manage hypertension even in extraordinary circumstances, such as earthquakes. Consequently, the study will assess how the mobile application influences individuals\&amp;#39; quality of life and disease self-efficacy.

Conducted between April 2024 and January 2026, the project adopts a pre-test post-test control group experimental design in the four most earthquake-affected provinces. It involves 614 individuals diagnosed with hypertension, residing in temporary living space in Malatya, Hatay, Kahramanmaraş, and Adıyaman, with 78, 77, and 74 participants in Malatya, Hatay, and Adıyaman, respectively. Data collection tools include the Personal Identification Information Form, Hypertension Self-Efficacy Scale, SF-36 Quality of Life Scale, and International Physical Activity Scale-Short Form, administered through face-to-face interviews. The mobile application development will be a collaborative effort with two faculty members from the Department of Computer Engineering and expert academicians. For the diet program within the application, eight questions will be used to uncover individuals\&amp;#39; dietary preferences. Calculations based on Body Mass Index, basal metabolic rate, and daily energy requirements will inform the diet program, which will encompass five food groups and their caloric values. Notifications about diet adherence will be sent for each meal. In the exercise program, individuals will measure and record blood pressure and medication intake. Those with a blood pressure of 140/90 mmHg or higher will be included based on expert physician recommendations, with notifications for those exceeding 160/100 mmHg to consult a physician. A personalized exercise program will be created based on the OMRİ-RİS scale, supported by animations. Training videos for blood pressure measurements and medication adherence will be recorded and supervised by local academic nurse practitioners. Data analysis will utilize appropriate statistical tests conducted through computer programs. The project is anticipated to contribute significantly to researcher development, enhance quality of life and disease management, increase productivity, and establish new projects. conditions: Hypertension, Essential Hypertension studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Our study has two groups of 78 participants each. Our study is an experimental study with pretest-posttest control group. primaryPurpose: OTHER masking: SINGLE maskingDescription: Participants will be determined blindly by being assigned by a site. whoMasked: PARTICIPANT count: 614 type: ESTIMATED name: mobile application measure: SF- 36 Life Quality Scale measure: Hypertension Self-Efficacy Scale measure: International Physical Activity Scale-Short Form sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06321146 id: LY2024-029-B briefTitle: Evaluation of EEG Power Spectrum in Patients With Traumatic Coma acronym: EPIC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-04-30 date: 2024-03-20 date: 2024-03-20 name: RenJi Hospital class: OTHER name: Beijing Tiantan Hospital name: Xiangya Hospital of Central South University name: The General Hospital of Eastern Theater Command name: Anhui No.2 Provincial People's Hospital briefSummary: Development of objective, reliable, and convenient assessment methods of disorders of consciousness is crucial. We aim to conduct multicenter prospective observational study and non-invasively collect EEG from patients with traumatic coma to analyze the sequential characteristics of EEG power spectrum, and explore their prognostic value for consciousness recovery. conditions: Coma conditions: Brain Injuries, Traumatic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 210 type: ESTIMATED measure: EEG power spectrum measure: Coma Recovery Scale-Revised (CRS-R) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui No.2 Provincial People's Hospital city: Hefei state: Anhui country: China name: Yongming Zhang, Dr. role: CONTACT lat: 31.86389 lon: 117.28083 facility: Beijing Tiantan Hospital, Capital Medical University city: Beijing state: Beijing country: China name: Guoyi Gao, Dr. role: CONTACT lat: 39.9075 lon: 116.39723 facility: Xiangya Hospital, Central South University city: Changsha state: Hunan country: China name: Jinfang Liu, Dr. role: CONTACT lat: 28.19874 lon: 112.97087 facility: The General Hospital of Eastern Theater Command city: Nanjing state: Jiangsu country: China name: Chiyuan Ma, Dr. role: CONTACT lat: 32.06167 lon: 118.77778 facility: Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University city: Shanghai state: Shanghai zip: 201114 country: China name: Junfeng Feng role: CONTACT phone: +8613611860825 email: fengjfmail@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06321133 id: 5402589 briefTitle: High Flow Nasal Cannula Weaning in Acute Bronchiolitis overallStatus: RECRUITING date: 2024-02-13 date: 2026-12-31 date: 2026-12-31 date: 2024-03-20 date: 2024-03-20 name: Kuopio University Hospital class: OTHER name: Central Finland Hospital District name: Mikkeli Central Hospital name: Siun sote briefSummary: The goal of this clinical study is to compared two different strategies to end high flow nasal cannula treatment in acute bronchiolitis. This study compared the immediate ending of high flow treatment to weaning strategy, in which the flow rate is gradually decreased. The aim is to assess if the immediate ending shortens the hospitalization time and whether it is a safe strategy. conditions: Acute Bronchiolitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: High flow nasal cannula immediate ending name: High flow nasal cannula weaning measure: Hospitalization time from randomization measure: Treatment failures measure: Readmission rate measure: Overall hospitalization time sex: ALL minimumAge: 0 Months maximumAge: 12 Months stdAges: CHILD facility: Siun Sote status: RECRUITING city: Joensuu country: Finland name: Paula Widgren, MD, PhD role: CONTACT phone: 0045813 330 8285 email: paula.widgren@siunsote.fi lat: 62.60118 lon: 29.76316 facility: Central Finland Hospital District status: RECRUITING city: Jyväskylä country: Finland name: Milla Pitkänen, MD role: CONTACT phone: 0035814 2691811 email: milla.pitkanen@hyvaks.fi lat: 62.24147 lon: 25.72088 facility: Kuopio University Hospital status: RECRUITING city: Kuopio country: Finland name: Ilari Kuitunen, MD, PhD role: CONTACT phone: +358447174910 email: ilari.kuitunen@uef.fi name: Marjo Renko, Professor role: CONTACT name: Katri Backman, MD, PhD role: SUB_INVESTIGATOR name: Miika Arvonen, MD, PhD role: SUB_INVESTIGATOR lat: 62.89238 lon: 27.67703 facility: Mikkeli Central Hospital status: RECRUITING city: Mikkeli country: Finland name: Nicole Weisshoff, MD role: CONTACT phone: 0035815 3511 email: nicole.weisshoff@etelasavonha.fi lat: 61.68857 lon: 27.27227 hasResults: False

 nctId: NCT06321120 id: 0749-21-HMO-CTIL briefTitle: Using Chronobiology to Improve Lenvatinib Efficacy overallStatus: RECRUITING date: 2023-03-01 date: 2024-04 date: 2024-06 date: 2024-03-20 date: 2024-03-20 name: Hadassah Medical Organization class: OTHER briefSummary: The goal of this proof-of-concept clinical trial is to assess the efficacy and safety of chronobiology implementation into lenvatinib treatment regimens of thyroid cancer patients, via a mobile application.

Participants will use a mobile application to follow variability-based physician approved drug administration schedules. conditions: Lenvatinib Treatment studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: An open-labeled, prospective, single-center proof-of-concept clinical trial lasting 14 weeks was conducted to investigate the impact of an algorithm-based regimen on enhancing lenvatinib effectiveness. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: variability-based lenvatinib regimen measure: disease progression/ tumor response measure: Adverse effects occurrence sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hadassah Medical Organization status: RECRUITING city: Jerusalem zip: 91120 country: Israel name: Hadas Lemberg, PhD role: CONTACT phone: +97226777572 email: lhadas@hadassah.org.il lat: 31.76904 lon: 35.21633 hasResults: False

 nctId: NCT06321107 id: GenSci094-304 briefTitle: Long-term Follow-up Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference overallStatus: RECRUITING date: 2024-02-29 date: 2025-08-15 date: 2025-10-31 date: 2024-03-20 date: 2024-03-20 name: Changchun GeneScience Pharmaceutical Co., Ltd. class: INDUSTRY name: Sixth Affiliated Hospital, Sun Yat-sen University briefSummary: The purpose of this study is to evaluate the safety of a single injection of GenSci094 during Controlled Ovarian Stimulation up to 1 year old of the infants from previous studies. conditions: Infertility studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 158 type: ESTIMATED measure: Summary of Pregnancy Outcome measure: neonatal birth outcomes measure: Infant development sex: FEMALE minimumAge: 20 Years maximumAge: 39 Years stdAges: ADULT facility: The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06321094 id: VERI-ACS briefTitle: Effect of Vericiguat on Endpoint Events in Acute Coronary Syndrome( ACS）Patients With Ejection Fraction <45% overallStatus: RECRUITING date: 2023-10-01 date: 2025-10-01 date: 2025-12-01 date: 2024-03-20 date: 2024-03-20 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: Investigators evaluate whether differences exsit in acute coronary syndrome（ACS） patients with ejection \<45% between participants who take vericiguat regularly and those who donot. conditions: Acute Coronary Syndrome conditions: Heart Failure With Reduced Ejection Fraction studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Vericiguat measure: a composite of death from cardiovascular causes or first hospitalization for heart failure measure: results of echocardiogram measure: the numerical value of NT-proBNP measure: level of procalcitonin measure: interleukin-6 level measure: life quality score sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu country: China name: Liansheng Wang, Doctor role: CONTACT phone: 85 25 68303830 email: drlswang@njmu.edu.cn lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06321081 id: 2023BJYYEC-428-02 briefTitle: ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC overallStatus: RECRUITING date: 2024-03-01 date: 2026-02-14 date: 2026-08-14 date: 2024-03-20 date: 2024-03-20 name: Beijing Hospital class: OTHER_GOV name: Bethune Charitable Foundation briefSummary: This is a non-profit phase II, open, clinical study of the combination of irinotecan plus cetuximab and envafolimab as a rechallenge regimen, in pre-treated RAS/BRAF wild type metastatic colorectal cancer patients (according to liquid biopsy at baseline). Patients have been treated in front lines with irinotecan and cetuximab and had a clinical benefit (complete or partial response) from both of them, no matter whether they had treated by any PD-1 inhibitor before. conditions: RAS Mutation conditions: Metastatic Colorectal Cancer conditions: MSS studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: irinotecan, cetuximab, envafolimab measure: progression free survival measure: Overal survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Hospital status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Yingying Huang role: CONTACT phone: 86-10-85136715 email: yinghh@hotmail.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06321068 id: BAT-1308-003-CR briefTitle: BAT1308 in Combination With Platinum-containing Chemotherapy is Used for the First-line Treatment of Advanced or Recurrent dMMR Endometrial Cancer overallStatus: RECRUITING date: 2024-04-09 date: 2024-09 date: 2027-10 date: 2024-03-20 date: 2024-04-18 name: Bio-Thera Solutions class: INDUSTRY briefSummary: Phase II study: Safety and preliminary efficacy of BAT1308 combined with platinum-containing chemotherapy;Phase III study: Confirmatory safety and efficacy study of BAT1308 combined with platinum-containing chemotherapy for first-line treatment of advanced or recurrent mismatch repair protein-deficient (dMMR) endometrial carcinoma conditions: Endometrial Cancer studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 140 type: ESTIMATED name: carboplatin name: Paclitaxel name: Recombinant humanized anti-PD-1 monoclonal antibody injection measure: vital signs measure: Physical examination measure: Adverse events measure: Clinical laboratory tests measure: Clinical auxiliary tests measure: Dose-limiting toxicity (DLT) measure: Progression Free Survival measure: Initial efficacy measure: Pharmacokinetic measure: Pharmacokinetic measure: Pharmacokinetic measure: Pharmacokinetic measure: Immunogenicity measure: Immunogenicity sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Cancer Hospital of Chongqing University status: RECRUITING city: Chongqing state: Chongqing country: China name: Qi Zhou role: CONTACT phone: 86-13708384529 email: qizhou9128@163.com lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06321055 id: 22533 briefTitle: An Observational Study to Learn More About Treatment With Regorafenib in People With Advanced Gastrointestinal Stromal Tumors in the United States overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-04-28 date: 2024-04-28 date: 2024-03-20 date: 2024-03-20 name: Bayer class: INDUSTRY briefSummary: This is an observational study in which data already collected from people with advanced gastrointestinal stromal tumors are studied.

In this observational study data are collected from participants who have private insurance or Medicare and who had started regorafenib treatment.

Gastrointestinal stromal tumor (GIST) is a type of cancer that most commonly originates from the stomach or small intestine. Advanced means that the cancer has spread to other parts of the body.

The study drug, regorafenib, is already approved for doctors to prescribe to people with GIST. Regorafenib works by blocking certain proteins that cause the growth of cancer cells. Regorafenib is recommended as the third choice of treatment for patients after imatinib and sunitinib have stopped working or have caused side effects that are too severe to continue the treatment. In addition, it is also the recommended first choice of treatment in people with GIST who had low levels of protein called succinate dehydrogenase (SDH) protein. This condition is called SDHdeficient GIST. However, doctors might sometimes give it in a different order. To better understand the treatment patterns with regorafenib for GIST, more knowledge is needed about its use in the real world.

The participants in this study had started treatment with regorafenib as part of their regular care from their doctors.

The main purpose of this study is to learn more about the use of regorafenib treatment among people with advanced GIST who have private insurance or Medicare in the United States. To do this, researchers will collect information on:

Duration of treatment with regorafenib (also known as duration of therapy)

The length of time it took for participants to switch to another GIST treatment after starting regorafenib (also known as time to next therapy)

The data will come from the participants' information stored in a database, called Merative MarketScan for people in the United States. Data collected will be from April 2002 to September 2023.

Researchers will track the data of people with GIST who started regorafenib and will follow them for at least 28 days.

In this study, only available data are collected. No visits or tests are required as part of this study. conditions: Advanced Gastrointestinal Stromal Tumor studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 136 type: ESTIMATED name: Regorafenib (Stivarga, BAY73-4506) measure: Duration of Therapy (DOT) on regorafenib measure: Time to Next Therapy (TTNT) therapy after regorafenib measure: Number of the guideline-listed medications other than regorafenib measure: Descriptive analysis of baseline demographic measure: Descriptive analysis of clinical characteristics measure: Number of patients with evidence of any metastasis on or after the index date during the follow-up period. measure: Number of patients with evidence of surgery on or after the index date during the follow-up period using Current Procedural Terminology (CPT) codes and International Classification of Disease 9/10 Procedure codes (ICD-PC). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bayer city: Whippany state: New Jersey zip: 07981 country: United States lat: 40.82454 lon: -74.4171 hasResults: False

 nctId: NCT06321042 id: SYMPHO-EM briefTitle: Evaluation of the Clinical Outcomes of the Total Knee ps Prosthesis Implanted With the Use of Inertial Sensors acronym: SYMPHO-EM overallStatus: RECRUITING date: 2023-01-13 date: 2027-01 date: 2027-03 date: 2024-03-20 date: 2024-03-20 name: Istituto Ortopedico Rizzoli class: OTHER briefSummary: evaluate the clinical outcome of the implantation of a specific primary TKA model implanted with the aid of inertial sensors for the execution of bone cuts through the administration of questionnaires for the calculation of clinical-functional scores; conditions: Prosthesis Durability studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Knee arthroplasty measure: Knee Society Score measure: Knee Society Score measure: Knee Society Score measure: Knee Society Score measure: Western Ontario and McMaster Universities Arthritis Index measure: Western Ontario and McMaster Universities Arthritis Index measure: Western Ontario and McMaster Universities Arthritis Index measure: Western Ontario and McMaster Universities Arthritis Index measure: Knee injury and Osteoarthritis Outcome Score measure: Knee injury and Osteoarthritis Outcome Score measure: Knee injury and Osteoarthritis Outcome Score measure: Knee injury and Osteoarthritis Outcome Score measure: 36-Item Short Form Health Survey measure: 36-Item Short Form Health Survey measure: 36-Item Short Form Health Survey measure: 36-Item Short Form Health Survey measure: Forgotten joint score measure: Forgotten joint score measure: Forgotten joint score measure: Forgotten joint score measure: Radiographic evaluation of prosthetic femoral component positioning sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stefano Zaffagnini status: RECRUITING city: Bologna state: Italia country: Italy name: Stefano Zaffagnini, MD role: CONTACT phone: 051 6366075 email: stefano.zaffagnini@unibo.it lat: 44.49381 lon: 11.33875 hasResults: False

 nctId: NCT06321029 id: 4-22-ICTSHD-44 briefTitle: Electronic Diabetes Tune-Up Group (eDTU) for African Americans overallStatus: RECRUITING date: 2023-10-19 date: 2024-12-31 date: 2025-03-31 date: 2024-03-20 date: 2024-03-20 name: Indiana University class: OTHER name: Indiana University Health briefSummary: The primary aims of this study are:

1. To test the acceptability and feasibility of the electronic DTU intervention (eDTU) that has been adapted for cultural relevance and online delivery compared to waitlist control and the in-person DTU (iDTU). The hypothesis is that the adapted intervention will be culturally acceptable (by participant satisfaction scores) and well-subscribed (intervention attendance rates).
2. To test differences in diabetes distress and A1c change scores between intervention (changes in T2 to T4) and waitlist control (change in T1 to T2) by intervention group (eDTU vs. waitlist control; iDTU vs. waitlist control). The hypothesis is that both the eDTU and iDTU groups will show significant improvements in diabetes distress and A1c compared to waitlist control. In order to conserve sample size and budget, participants in each intervention group will serve as their own waitlist control.

Secondary Objective. The secondary aim of the study is to evaluate changes in depressive symptoms, diabetes self-efficacy, and general and diabetes-specific quality of life in intervention (T2-T3 \& T4) compared to waitlist control (T1-T2). An exploratory aim will be to compare changes in eDTU to the iDTU pre/post intervention (T2-T3 \& T4). The hypothesis is that both groups will show comparable improvements in diabetes distress and A1c. conditions: Diabetes Mellitus, Type 2 conditions: Diabetes Complications studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single group waitlist control primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Diabetes Tune-Up Group measure: Diabetes Distress Scale-17 (DDS-17) measure: HbA1c (A1c) measure: Acceptability of intervention (content and delivery modality) measure: Feasibility of intervention and delivery modality measure: Patient Health Questionnaire-9 (PHQ-9) measure: Confidence in Diabetes Self-Care (CDSC) measure: Short Form-12 (SF-12) measure: Diabetes Therapy-Related Quality of Life Questionnaire sex: FEMALE minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Indiana University School of Medicine status: RECRUITING city: Indianapolis state: Indiana zip: 46202 country: United States name: Barb Myers, MS role: CONTACT phone: 317-278-7339 email: bamyers@iu.edu name: Mary de Groot, PhD role: CONTACT phone: 317-278-1965 email: mdegroot@iu.edu name: Mary de Groot, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.76838 lon: -86.15804 hasResults: False

 nctId: NCT06321016 id: 2023111039 briefTitle: POZIKIDS: Exercise and Comprehensive Care to Improve the Quality of Life of Children and Adolescents With Cancer acronym: PoziKids overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-06-30 date: 2026-12-30 date: 2024-03-20 date: 2024-03-20 name: Nere Mendizabal class: OTHER_GOV briefSummary: Objective: To assess the feasibility of a supervised, controlled and personalised physical exercise programme and its potential efficacy in improving functional capacity and quality of life in children and adolescents with cancer.

Design: Hybrid quasi-experimental pilot trial, clinical and phase I implementation.

Methods: The learning collaborative approach based on the Institute for Healthcare Improvement Breakthrough Series Collaborative Model will be followed through quarterly Plan-Do-Study-Act (P-D-S-A) cycles. Participants: For feasibility, at least, 45 patients will be included in 3 successive PDSA cycles of at least 15 patients each, aged 4-18 years diagnosed with any type of cancer. Variables: clinical and socio-demographic, body composition, physical condition and mobility, quality of life, physical activity and implementation. Intervention: Everyone will receive a physical exercise intervention combining strength and aerobic capacity work. Initially it will be carried out in the hospital setting, and later in streaming supervised by a professional. The intervention will be modelled through a formative evaluation process with the collaboration of all the agents involved, experimenting in each cycle with an increasingly adapted version of the exercise programme.

Statistical analysis: Recruitment rates will be calculated, characteristics associated with project participation and adherence to the exercise programme will be identified. Outcome variables will be compared before and after the intervention, identifying those with the greatest validity, reliability and sensitivity to change, which will then be used in phase II and III trials. conditions: Exercise conditions: Childhood Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 45 type: ESTIMATED name: Physical exercise program name: Type of the physical exercise program measure: Quarterly recruitment rates assessed by comparing those who participate with those who do not. measure: Adherence rates assessed by the proportion of sessions completed and adherence to the prescribed exercise protocol measure: Body composition assessed by the Body Mass Index measure: Muscle mass measure: Bone mineral density measure: Physical condition assessed by the 6 min walking test and manual grip test with a dynamometer measure: Muscular strength assessed by manual grip test with a dynamometer measure: General Quality of life assessed by the PedsQL 4.0 questionnaire measure: Specific Quality of life assessed by the PedsQL cancer questionnaire measure: Fatigue assessed by the PedsQL Multidimensional Fatigue Scale Acute Version (PedsQL-MFS) measure: Physical activity level assessed by accelerometers measure: Security assessment measure: Costs associated estimation measure: Implementation barriers and facilitators sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06321003 id: OCT01 briefTitle: SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography acronym: SYMILIS OCT overallStatus: RECRUITING date: 2024-03-13 date: 2027-04-01 date: 2027-04-01 date: 2024-03-20 date: 2024-03-20 name: University of Palermo class: OTHER briefSummary: This clinical trial aims to assess the efficacy of Optical Coherence Tomography (OCT) in the early diagnosis of oral cancer. It focuses on Oral Potentially Malignant Disorders (OPMDs) as precursors to Oral Squamous Cell Carcinoma (OSCC). Despite the availability of oral screening, diagnostic delays persist, underscoring the importance of exploring non-invasive methodologies. The OCT technology provides cross-sectional analysis of biological tissues, enabling a detailed evaluation of ultrastructural oral mucosal features.

The trial aims to compare OCT preliminary evaluation with traditional histology, considered the gold standard in oral lesion diagnosing. It seeks to create a database of pathological OCT data, facilitating the non invasive identification of carcinogenic processes. The goal is to develop a diagnostic algorithm based on OCT, enhancing its ability to detect characteristic patterns such as the keratinized layer, squamous epithelium, basement membrane, and lamina propria in oral tissues affected by OPMDs and OSCC.

Furthermore, the trial aims to implement Artificial Intelligence (AI) in OCT image analysis. The use of machine learning algorithms could contribute to a faster and more accurate assessment of images, aiding in early diagnosis. The trial aims to standardize the comparison between in vivo OCT images and histological analysis, adopting a site-specific approach in biopsies to improve correspondence between data collected by both methods.

In summary, the trial not only evaluates OCT as a diagnostic tool but also aims to integrate AI to develop a standardized approach that enhances the accuracy of oral cancer diagnosis, providing a significant contribution to clinical practice. conditions: Oral Squamous Cell Carcinoma conditions: Oral Potentially Malignant Disorder conditions: Oral Leukoplakia conditions: Proliferative Verrucous Leukoplakia conditions: Oral Lichen Planus conditions: Oral Lichenoid Lesion conditions: Graft-versus-host-disease conditions: Oral Erythroplakia conditions: Actinic Keratoses conditions: Actinic Cheilitis conditions: Oral Cancer conditions: Oral Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: OCT (Optical Coherence Tomography) measure: Phase I: Standardization of Biopsy and OCT Imaging Techniques measure: Phase II: Development of Standardized OCT Patterns, Creation of Comprehensive Image Repository, and Training Algorithms measure: Phase III: Development and Large-Scale Validation of Diagnostic OCT Software sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Palermo status: RECRUITING city: Palermo country: Italy role: CONTACT phone: 091 238 93011 email: pec@cert.unipa.it lat: 38.13205 lon: 13.33561 hasResults: False

 nctId: NCT06320990 id: 0074-24-CB briefTitle: Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection acronym: MCN_Tam overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-11 date: 2027-05 date: 2024-03-20 date: 2024-03-20 name: University of Nebraska class: OTHER briefSummary: This is an open-label pilot study of tamoxifen as chemoprevention in patients with pancreatic MCN who will not undergo immediate resection. Up to 15 subjects will be enrolled and take tamoxifen 20mg by mouth daily for up to 24 weeks. conditions: Pancreatic Cyst conditions: Pancreatic Mucinous Cystic Neoplasm studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 15 type: ESTIMATED name: Tamoxifen 20mg measure: Feasibility, by adherence rate measure: Feasibility, by retention rate measure: Objective response rate (ORR) of pancreatic MCN sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Nebraska Medical Center city: Omaha state: Nebraska zip: 68198 country: United States name: Christina Hoy, DNP role: CONTACT email: choy@nebraskamed.com name: Kelsey Klute, MD role: PRINCIPAL_INVESTIGATOR lat: 41.25626 lon: -95.94043 hasResults: False

 nctId: NCT06320977 id: ESS/FSA-397/23-2 briefTitle: The Influence of Acute Static Stretching on the Ankle Joint-position Sense of Soccer Players overallStatus: COMPLETED date: 2024-02-12 date: 2024-03-13 date: 2024-03-29 date: 2024-03-20 date: 2024-04-09 name: University Fernando Pessoa class: OTHER briefSummary: The aim of this study isto investigate the influence of acute static stretching on the ankle joint position sense of soccer players. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 19 type: ACTUAL name: Static Stretching measure: Absolute angular error measure: Relative angular error measure: Variable angular error sex: MALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Escola Superior de Saúde Fernando Pessoa city: Porto zip: 4200-253 country: Portugal lat: 41.14961 lon: -8.61099 hasResults: False

 nctId: NCT06320964 id: R01HD108252_1 id: R01HD108252 type: NIH link: https://reporter.nih.gov/quickSearch/R01HD108252 briefTitle: The TARANG Intervention acronym: TARANG Pilot overallStatus: COMPLETED date: 2023-07-14 date: 2024-01-21 date: 2024-01-21 date: 2024-03-20 date: 2024-03-20 name: University of California, San Francisco class: OTHER name: Network for Engineering and Economics Research and Management name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) name: Vikalp Sansthan briefSummary: The mixed methods pilot study aims to evaluate the acceptability, feasibility, and implementation challenges of the TARANG intervention in villages in rural/tribal Rajasthan to inform the study design and operational details for a larger cluster-randomized controlled trial. conditions: Feasibility conditions: Acceptability conditions: Family Planning conditions: Unintended Pregnancy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 135 type: ACTUAL name: TARANG measure: Feasibility of the intervention measure: Acceptability measure: Usefulness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vikalp Sansthan city: Udaipur state: Rajasthan country: India lat: 24.58584 lon: 73.71346 hasResults: False

 nctId: NCT06320951 id: 300012681 id: Pending type: OTHER domain: Pending briefTitle: VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine Mono-Phosphate Signaling Pathway acronym: VITAL-IMPACT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-04-30 date: 2029-04-30 date: 2024-03-20 date: 2024-04-10 name: University of Alabama at Birmingham class: OTHER briefSummary: This study investigates the potential of vericiguat, a soluble guanylate cyclase stimulator, to improve cardiometabolic health in obese Black individuals with insulin resistance by directly enhancing cyclic guanosine monophosphate (cGMP) activity. Given that this population has been shown to have lower cGMP activity and the association of lower cGMP activity with increased cardiometabolic disease risk, the proposed study hypothesizes that augmenting cGMP activity in obese individuals will improve insulin sensitivity and energy expenditure. This study is a placebo-controlled randomized trial involving 200 Black obese participants with insulin resistance, assessing the effects of vericiguat on insulin sensitivity, resting, and exercise-induced energy expenditure over 12 weeks. Additionally, it will explore changes in brown adipose tissue and gene expression related to energy metabolism in white adipose tissue, aiming to provide insights into how increasing cGMP activity may improve cardiometabolic health in Black obese individuals. conditions: Cardiovascular Diseases conditions: Insulin Sensitivity/Resistance conditions: Metabolic Disease conditions: Metabolism conditions: Energy Expenditure conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Vericiguat 10 MG name: Placebo name: Insulin Sensitivity Test name: Resting Energy and Exercise Energy Expenditure Assessment name: White Adipose Tissue Biopsy name: MRI-PET Scan for Brown Adipose Tissue Volume Assessment measure: Change in insulin sensitivity after vericiguat in Black obese individuals with insulin resistance. measure: Change in resting energy expenditure (REE) after vericiguat in Black obese individuals with insulin resistance. measure: Change in BAT volume after vericiguat in Black obese individuals with insulin resistance. measure: Change in BAT activity after vericiguat in Black obese individuals with insulin resistance. measure: Change in UCP1 gene expression after vericiguat in Black obese individuals with insulin resistance. measure: Change in exercise energy expenditure (EEE) after vericiguat in Black obese individuals with insulin resistance. measure: Change in glycosylated hemoglobin (HbA1C) after vericiguat in Black obese individuals with insulin resistance. measure: Change in Body Mass Index (BMI) after vericiguat in Black obese individuals with insulin resistance. measure: Change in Total Cholesterol (TC) after vericiguat in Black obese individuals with insulin resistance. measure: Change in low-density lipoprotein-cholesterol (LDL-C) after vericiguat in Black obese individuals with insulin resistance. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States lat: 33.52066 lon: -86.80249 hasResults: False

 nctId: NCT06320938 id: 2024/18 briefTitle: Effectiveness of Neuroscience-based Pain Education in Patients With Chronic Neck Pain overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2024-09-15 date: 2025-03-15 date: 2024-03-20 date: 2024-03-27 name: Turkoglu Dr. Kemal Beyazit State Hospital class: OTHER briefSummary: The effectiveness of neuroscience-based pain education, myofascial induction technique, and home exercise programs will be compared in patients with chronic neck pain. conditions: Cervical Spine Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Neuroscience-Based Pain Education Combined with Home Exercise Program name: Myofascial Induction Techniques Combined with Home Exercise Program name: Home Exercises Group measure: Short Form McGill Pain Questionnaire measure: Algometric Digital Measurement measure: Central Sensitization Inventory measure: Head Posture Evaluation measure: Neck Disability Index measure: Pittsburgh Sleep Quality Index measure: 36-Item Short Form Health Survey Questionnaire measure: Pain Catastrophizing Scale sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Türkoğlu Dr. Kemal Beyazıt State Hospital city: Kahramanmaraş country: Turkey lat: 37.5847 lon: 36.92641 hasResults: False

 nctId: NCT06320925 id: SYK-SM-2022-02 briefTitle: SportsPro: Post-Market Clinical Follow Up Study overallStatus: RECRUITING date: 2023-12-05 date: 2024-06-30 date: 2024-12-01 date: 2024-03-20 date: 2024-03-22 name: Stryker Endoscopy class: INDUSTRY briefSummary: Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice) conditions: Shoulder Injuries conditions: Knee Injuries conditions: Hip Injuries studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 1500 type: ESTIMATED name: Standard of Care Treatment measure: ASES measure: iHOT-12 measure: mHHS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Musculoskeletal-Orthopedic Research and Education Foundation status: RECRUITING city: Phoenix state: Arizona zip: 85023 country: United States name: Wafa Mohsin role: CONTACT email: wafa.mohsin@more-foundation.org name: Michael Amini, MD role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: Steadman Hawkins Clinic Denver status: RECRUITING city: Englewood state: Colorado zip: 80112 country: United States name: Lauren Heylmun role: CONTACT email: LAUREN.HEYLMUN@CUANSCHUTZ.EDU name: James Genuario, MD role: PRINCIPAL_INVESTIGATOR lat: 39.64777 lon: -104.98776 facility: TSAOG Orthopaedics & Spine status: RECRUITING city: San Antonio state: Texas zip: 78258 country: United States name: Amanda Strickland role: CONTACT email: astrickland@brioresearch.org name: Robert Hartzler, MD role: PRINCIPAL_INVESTIGATOR lat: 29.42412 lon: -98.49363 hasResults: False

 nctId: NCT06320912 id: TIPS01 briefTitle: Efficacy and Safety of Intraparenchymal Portal Vein Covered Stents in Treating Portal Hypertension and Its Complications overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2026-06-01 date: 2026-11-01 date: 2024-03-20 date: 2024-03-20 name: Shanghai Shenqi Medical Technology Co., Ltd class: INDUSTRY briefSummary: The objective of this study is to assess the non-inferiority of the intraparenchymal portal vein covered stent in terms of safety and efficacy for managing portal hypertension and its related complications, in comparison to the currently available TIPS Covered Stent System by GORE. conditions: Portal Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 258 type: ESTIMATED name: The intraparenchymal portal vein covered stent name: TIPS Covered Stent System GORE measure: Postoperative Stent Patency Rate measure: Immediate Postoperative Technical Success Rate measure: Incidence of Secondary Interventions at 1 Month, 6 Months, and 12 Months Postoperatively measure: Incidence of Stent Dysfunction at 1 Month, 6 Months, and 12 Months Postoperatively measure: Incidence of Major Adverse Events (MAE) at 1 Month, 6 Months, and 12 Months Postoperatively measure: All-Cause Mortality Rates at 1 Month, 6 Months, and 12 Months Postoperatively measure: Incidence of Grade II or Higher Hepatic Encephalopathy at 1 Month, 6 Months, and 12 Months Postoperatively measure: Incidence of Portal Hypertension Rebleeding Confirmed by Endoscopy or Clinical Investigator at 1 Month, 6 Months, and 12 Months Postoperatively (For Original Bleeding Subjects Only) measure: Incidence of Ultrasound-Confirmed Recurrence of Grade 2 or Higher Ascites due to Portal Hypertension at 1 Month, 6 Months, and 12 Months Postoperatively (For Subjects with Original Ascites Only) measure: Incidence of Adverse Events/Serious Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Southern Medical University Nanfang Hospital city: Guangzhou state: Guangdong country: China name: Jianbo Zhao role: CONTACT lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06320899 id: SpineShape_CH_001 id: BASEC 2023-D0092 type: OTHER domain: Ethics Committee Bern briefTitle: Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2031-08-31 date: 2031-08-31 date: 2024-03-20 date: 2024-03-20 name: SpineSave AG class: INDUSTRY briefSummary: The purpose of this multi-center, randomized, clinical study is to show that the treatment of degenerative lumbar spine with high- or mid-flex rods is not inferior to the treatment with low-flex rods in terms of clinical and safety-related results.

The primary aim is to compare the reduction in back pain after the treatment with high- or mid-flex rods with that after treatment with low-flex rods. Secondary, the functionality after treatment with high- or mid-flex rods will be compared to that after treatment with low-flex rods. conditions: Degenerative Lumbar Spinal Stenosis conditions: Facet Joint Arthrosis conditions: Spondylarthritis conditions: Discopathy conditions: Degenerative Spondylolisthesis conditions: Instability Lumbar Spine studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 126 type: ESTIMATED name: SpineShape System IV straight rod elastic name: SpineShape System IV straight rod medium name: SpineShape System IV straight rod stiff measure: VAS Score lower back pain measure: VAS Score leg pain measure: walking duration measure: medication consumption measure: adverse events measure: segmental mobility index level measure: ability to work/ activity (for retirees) sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06320886 id: Soh-Med-24-02-05MS briefTitle: Role of Ultrasonography in Acute Abdomen in Adults in Correlation to Computed Tomography Scan overallStatus: RECRUITING date: 2024-02-01 date: 2024-10-31 date: 2024-10-31 date: 2024-03-20 date: 2024-03-20 name: Sohag University class: OTHER briefSummary: The study aims to evaluate the role of Ultrasonography in the diagnosis of the cause of acute abdominal pain in 50 adults presenting in the ER at Sohag University Hospital and compares it to the Computed Tomography scan results of the same patients to discover the superiority of both over the other in the diagnosis of different acute abdomen cases. conditions: Acute Abdomen conditions: In Adults studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 50 type: ESTIMATED name: Diagnostic Test measure: Comparison between the role of Ultrasonography and Computed Tomography in Acute Abdomen diagnosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag University Hospital status: RECRUITING city: Sohag country: Egypt name: Magdy M Amin, Proffesor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06320873 id: zselcuk1 briefTitle: The Effect of Respiratory on Sports Performance in Archers overallStatus: COMPLETED date: 2021-07-26 date: 2022-01-01 date: 2022-01-01 date: 2024-03-20 date: 2024-03-20 name: Halic University class: OTHER briefSummary: Purpose: The physical, physiological, and functional characteristics of archers affect target shooting performance. In our study, we aimed to examine the effect of pulmonary functions and respiratory muscle strength on sports performance in archers.

Methods: Our study included 46 (27 female, 19 male) professional archers registered in archery sports clubs. Sociodemographic and physical characteristics were recorded. Pulmonary function test (PFT), respiratory muscle strength, shooting performance test, Moberg-pickup collection test, Nelson hand reaction test, and Fatigue Severity Scale (FSS) were applied to all participants. conditions: Sports Physical Therapy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 46 type: ACTUAL name: archery respiratory parameters measure: FEV1 (liter) measure: FEV1 (%-percentage) measure: FVC (liter) measure: FVC (%-percentage) measure: FEV1/FVC (percentage) measure: Inspiratory muscle test measure: Expiratory muscle test measure: Shooting performance measure: Nelson Hand Reaction Test measure: Moberg-pickup collection test measure: The Fatigue Severity Scale (FSS) sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Halic University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06320860 id: IRB231189 briefTitle: FlexStone Enabled Kidney Stone Retrieval overallStatus: ENROLLING_BY_INVITATION date: 2024-03-08 date: 2024-09-08 date: 2024-09-08 date: 2024-03-20 date: 2024-03-20 name: EndoTheia class: INDUSTRY name: Vanderbilt University Medical Center briefSummary: This study investigates if additional basket control in helpful during retrieval of kidney stones especially those that are difficult to reach for standard baskets. conditions: Kidney Calculi studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 10 type: ESTIMATED name: Kidney Stone Retrieval measure: Successful retrieval of kidney stones sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vanderbilt University Medical Center city: Nashville state: Tennessee zip: 37203 country: United States lat: 36.16589 lon: -86.78444 hasResults: False

 nctId: NCT06320847 id: Predictbloodpressure briefTitle: Predictive Remote Photoplethysmography Algorithm for Blood Pressure Pressure Assessment and Monitoring overallStatus: RECRUITING date: 2024-01-02 date: 2024-12 date: 2024-12 date: 2024-03-20 date: 2024-03-20 name: Singapore General Hospital class: OTHER name: Nervotec Pte. Ltd. briefSummary: Significant advancements in the field of medical technologies have resulted in the rise of contact-free methods of haemodynamic monitoring. Remote photoplethysmography (rPPG) is a videobased, contactless form of monitoring that operates through a camera-enabled device. This innovation interprets minute variations in skin colour due to blood flow which, when analysed with complex signal processing algorithms, generates vital sign readings. Currently, Nervotec's rPPG technology allows for the collection of rPPG waveforms, which enables the measurement of heart rate, heart rate variability, respiration rate and blood oxygen saturation (SpO2) level through signal processing techniques. The plethysmography signals can be used to estimate blood pressure through the creation and training of a predictive model. By examining and extracting key features of a continuous PPG waveform by training an artificial neural network, correlations between these features and BP can be studied. conditions: Remote Photoplethysmography , Blood Pressure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 300 type: ESTIMATED name: rPPG measure: To determine the correlation between remote photoplethysmography (rPPG) and blood pressure variations. measure: To develop a predictive model in using rPPG for determination of blood pressure. measure: To validate this predictive model by comparing blood pressure readings obtained using rPPG with standard procedures such as contact sensors and automated oscillometry. sex: ALL minimumAge: 21 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Singapore General Hospital status: RECRUITING city: Singapore zip: 169608 country: Singapore name: Hairil Rizal Abdullah role: CONTACT phone: 63265428 email: hairil.rizal.abdullah@singhealth.com.sg name: Hairil Rizal Abdullah role: PRINCIPAL_INVESTIGATOR name: Jia Xin Chai role: SUB_INVESTIGATOR lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06320834 id: PTL-1000294 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-03-20 date: 2024-03-20 name: [Redacted] hasResults: False

 nctId: NCT06320821 id: RAKT Version 1.0 briefTitle: RAKT OUTCOME ANALYSIS overallStatus: ENROLLING_BY_INVITATION date: 2021-08-21 date: 2024-05-30 date: 2024-08-30 date: 2024-03-20 date: 2024-03-20 name: Seoul National University Hospital class: OTHER briefSummary: The goal of this observational study is to compare outcomes of robot-assisted kidney transplantation and open kidney transplantation. The main questions are

- comprehensively analyze our early experience of robot-assisted kidney transplant patients and compare the results with those of open kidney transplant patients conditions: Kidney Transplantation conditions: Robotic Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED measure: learning curve measure: renal function sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital city: Seoul zip: 110-744 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06320808 id: STUDY2023_00000449 briefTitle: Evaluating FDA's Proposed Patient Medication Information Handout overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-03 date: 2024-04-30 date: 2025-03-03 date: 2024-03-20 date: 2024-04-24 name: Carnegie Mellon University class: OTHER name: University of Pittsburgh briefSummary: The goal of this study is to assess how useful the proposed one-page FDA-template PMI is to potential users.

The main questions it aims to answer are:

How does the proposed one-page FDA-template PMI compare with the current drug information insert in terms of usefulness and comprehension?

and

How does the proposed one-page FDA-template PMI compare with a revision adding drug benefit information?

Participants will randomized to review one of three patient medication information sheets and then asked questions related to usefulness and comprehension. conditions: Knowledge conditions: Attitude studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to receive either the one-page FDA-template PMI (FDA PMI), a modified template, which added information about drug benefits (Decision Critical PMI), or the existing drug information insert (standard drug information). Participants will complete the same survey questions measuring perceived usefulness and comprehension of the information. primaryPurpose: OTHER masking: SINGLE whoMasked: INVESTIGATOR count: 330 type: ESTIMATED name: FDA template PMI name: Decision Critical PMI name: Standard Information measure: Perceived difficulty or ease in reading information measure: Perceived usefulness of the medication information guide in making a use decision measure: Perceived usefulness of the medication information guide in taking the medication properly measure: Comprehension measure: Strength of Evidence sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Carnegie Mellon University city: Pittsburgh state: Pennsylvania zip: 15213 country: United States lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06320795 id: IT-MF-000031905 briefTitle: Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device acronym: SOUNDI overallStatus: RECRUITING date: 2023-11-22 date: 2024-03-01 date: 2024-05-31 date: 2024-03-20 date: 2024-03-20 name: Biocubica srl class: INDUSTRY briefSummary: This is a pre-marketing, single-centre, prospective clinical trial with the aim of comparison the effectiveness and safety of the SOUNDI medical device compared to polysomnography in detecting parameters for the diagnosis of obstructive sleep apnea (OSA) syndrome in subjects with suspected diagnosis of sleep disorders. conditions: OSA studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: SOUNDI measure: To evaluate the accuracy of the clinical diagnosis of OSA measure: To evaluate the agreement between the Apnea Hypopnea Index (AHI) from the home sleep study with SOUNDI and the home sleep study with polysomnography (PSG) measure: Patient satisfaction sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ambulatorio del Sonno- Istituto Auxologico Italiano IRCCS - Ospedale San Luca status: RECRUITING city: Milan zip: 20149 country: Italy name: Carolina Lombardi, Prof. role: CONTACT name: Carolina Lombardi, Prof. role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-02-15 uploadDate: 2024-03-13T09:06 filename: Prot_000.pdf size: 2928638 hasResults: False

 nctId: NCT06320782 id: 4659262 briefTitle: Effects of Different Dietary Interventions on Abdominal Fat Components and Cardiometabolic Parameters. overallStatus: ENROLLING_BY_INVITATION date: 2021-08-23 date: 2023-12-26 date: 2024-08 date: 2024-03-20 date: 2024-03-20 name: University of Pernambuco class: OTHER name: Universidade Federal de Pernambuco briefSummary: The study aims to evaluate the impact of different dietary interventions on abdominal fat components and cardiometabolic parameters. This is a randomized clinical trial study conducted in overweight adults, selected by voluntary adherence, in an outpatient clinic of a cardiology hospital. The sample was calculated based on data from a study with the Brazilian population, with the sample size calculated as a function of a mean difference (d) in visceral adipose tissue (VAT) after the interventions, standard deviation (s) and a significance level of 5% (z). To correct eventual losses, the number was increased by 20%. Four dietary interventions will be applied in the 6-month period: group with calorie restriction and balanced distribution of macronutrients (group 1); group with calorie restriction and low-carbohydrate diet (group 2); group with calorie restriction and low-fat diet (group 3) and group with collective nutritional guidance (group 4). Patients will be followed up monthly to assess weight loss, analyze adherence to the diet therapy plan, reinforce nutritional guidelines and monitor anthropometric measurements and abdominal adipose tissue. The evaluation of VAT and subcutaneous adipose tissue (SAT) by ultrasonography will be performed at baseline and after 6 months of intervention. The present study is expected to clarify the effects that different dietary interventions produce over 6 months on abdominal fat deposits and cardiometabolic parameters. conditions: Abdominal Obesity conditions: Cardiac Disease conditions: Metabolic Disease conditions: Cardiometabolic Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 4 interventions distributed in a randomized manner among 4 different groups primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The data analysis and interpretation stage will be carried out by the study coordinator, who will not have knowledge about the allocation of participants among the intervention groups whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Calorie restriction and balanced distribution of macronutrients name: Calorie restriction and low-carbohydrate diet name: Calorie restriction and low-fat diet name: Collective nutritional guidance measure: Thickness, measured in centimeters, of visceral adipose tissue measure: Weight loss measured in kilograms measure: Serum levels of fasting glucose measure: Serum levels of Insulin measure: Serum levels Triglycerides measure: Serum levels Lipid profile measure: Serum levels C-reactive protein (hs-CRP) sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Isa Galvao Rodrigues city: Recife state: PE zip: 51021120 country: Brazil lat: -8.05389 lon: -34.88111 hasResults: False

 nctId: NCT06320769 id: 24101994 briefTitle: Role of Rotational Guided Growth in Management of Increased Femoral Anteversion overallStatus: RECRUITING date: 2024-02-20 date: 2026-03-01 date: 2026-03-01 date: 2024-03-20 date: 2024-03-20 name: Ain Shams University class: OTHER briefSummary: Efficacy of guided growth in coronal plane deformity correction and limb length discrepancy has been well-established. Recently, studies have explored the validity of guided growth in correction of rotational deformity through a modified method of application.

This concept has been validated in animal studies, biomechanical studies and two limited human case series through different methods.

This study evaluates the efficacy of rotational guided growth in management of increased femoral anteversion using three different constructs. conditions: Increased Femoral Anteversion studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Plate Technique measure: Gait measure: Limb length discrepancy measure: Angular Deformities sex: ALL minimumAge: 8 Years maximumAge: 16 Years stdAges: CHILD facility: Faculty of Medicine, Ainshams University status: RECRUITING city: Cairo state: El-Waily country: Egypt name: Tarek Hassan Abdelaziz, Professor role: CONTACT phone: +201222421760 email: drtarekibrahim@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06320756 id: 24-WYSA-101 briefTitle: Examining the Feasibility of Wysa in Hindi overallStatus: RECRUITING date: 2024-02-23 date: 2024-05 date: 2024-05-31 date: 2024-03-20 date: 2024-03-20 name: Wysa class: INDUSTRY name: Udaan briefSummary: The principal objective of this study is to investigate the feasibility of including a digital mental health intervention (Wysa in Hindi) within pre-existing usual care to support adolescents and young adults with Type 1 Diabetes (T1D) who have mild and above mental health distress (operationalized as Patient Health Questionnaire-9: 5-14 scores; or Diabetes Distress Scale-17: \>2.0 mean score) with their mental health distress. This will be conducted through an exploratory randomized control study comparing Wysa in Hindi plus usual care with a control arm that just has usual care. The study further explores the effectiveness of the digital mental health intervention using the Patient Health Questionnaire (PHQ-9) and Diabetes Distress Scale (DDS-17). conditions: Mental Health Issue conditions: Diabetes Distress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Control Trial with an intervention arm and a control arm. primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 204 type: ESTIMATED name: Wysa in Hindi name: Individual and group sessions on topics like motivation, coping, wellbeing measure: Feasibility - Recruitment rate (Proportion of participants who completed consent procedures) measure: Feasibility - Retention rate (Proportion of participants who remained enrolled within the study for the entire study duration) measure: Feasibility - Wysa Engagement (Proportion of recruited participants who engaged in at least 1 interaction with the Wysa app) measure: Feasibility - App therapist engagement rate (Proportion of recruited participants who completed at least one therapist session within the Wysa app) measure: Satisfaction with the app which is collected through 3 quantitative questions and 1 free text qualitative question on the app measure: Therapist Satisfaction feedback collected through 3 quantitative questions and 1 free text qualitative question on the app measure: Change in mental health distress as measured by the Patient Health Questionnaire (PHQ-9) measure: Change in mental health distress as measured by the Diabetes Distress Scale (DDS-17) sex: ALL minimumAge: 13 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Udaan status: RECRUITING city: Aurangabad state: Maharashtra zip: 431003 country: India name: Archana Sarda, M.D role: CONTACT phone: 9730792405 email: dr.archana.sarda@gmail.com name: Saumya Sarda, B.A role: CONTACT phone: 8698351351 lat: 19.87757 lon: 75.34226 hasResults: False

 nctId: NCT06320743 id: Low Flow Anaesthesia And NIRS briefTitle: Cerebral and Peripheral Near Infrared Spectroscopy Monitoring in Low and High Flow Anaesthesia in Pediatric overallStatus: RECRUITING date: 2024-03-20 date: 2024-08-19 date: 2024-09-19 date: 2024-03-20 date: 2024-03-21 name: Ankara City Hospital Bilkent class: OTHER briefSummary: To investigate the effects of non-invasive cerebral and peripheral NIRS monitoring and low and high flow sevoflurane anaesthesia on cerebral and peripheral NIRS in paediatric patients. To determine the effects of two different flows on these monitoring techniques and thus to facilitate intraoperative patient monitoring and to predict complications (hypoxia) that may occur. conditions: Child, Only conditions: Inhalation; Vapor conditions: Anesthesia conditions: Cerebral Oxygenation conditions: Cerebral Hypoxia conditions: Peripheral Oxygenation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Cerebral NIRS probe will be attached to the right and left frontotemporal region, and a peripheral NIRS probe will be attached to the inner surface of the forearm and the values will be noted. primaryPurpose: OTHER masking: NONE count: 56 type: ESTIMATED name: NIRS ,Ventilation parameters name: Oxygen concentration measure: Near infrared spectroscopy (NIRS) measure: Ventilation parameters measure: Ventilation parameters measure: Ventilation parameters measure: Ventilation parameters measure: Ventilation parameters measure: Ventilation parameters measure: Ventilation parameters measure: İntraoperative sevoflurane consumption sex: ALL minimumAge: 2 Years maximumAge: 12 Years stdAges: CHILD facility: Ankara Bilkent City Hospital status: RECRUITING city: Ankara state: Çankaya zip: 06800 country: Turkey name: Rabia Bayar role: CONTACT phone: 5393300403 email: rabiabtlbayar@gmail.com lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06320730 id: 2020-0675 briefTitle: Impact of Glycemic Control After Reperfusion on Acute Kidney Injury in Living Donor Liver Transplantation overallStatus: COMPLETED date: 2020-08-25 date: 2020-08-29 date: 2021-03-01 date: 2024-03-20 date: 2024-03-20 name: Asan Medical Center class: OTHER briefSummary: This retrospective cohort study of patients classified by the blood glucose level after reperfusion in liver transplantation repicient. Our object is to investigate whether controlling BG levels within the optimal range during neohepatic phase is associated with a reduction of AKI incidence. Furthermore, severe AKI, chronic kidney disease (CKD), major adverse cardiac event (MACE) and mortality were also investigated. conditions: Acute Kidney Injury conditions: Hyperglycemia conditions: Hypoglycemia conditions: End Stage Liver Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3790 type: ACTUAL name: Observational study, records of blood glucose level after reperfusion measure: incidence of acute kidney injury measure: incidence of severe AKI measure: incidence of chronic kidney disease (CKD) measure: incidence of Major adverse cardiac event (MACE) measure: overall mortality sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jun-Gol Song city: Seoul state: Song-pa Gu zip: 05500 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06320717 id: I-3574823 briefTitle: AI Derived Biomarker to Select Neoadjuvant Treatment for Borderline Resectable Pancreatic Ductal Adenocarcinoma overallStatus: RECRUITING date: 2024-01-02 date: 2026-07-02 date: 2026-07-02 date: 2024-03-20 date: 2024-03-20 name: Roswell Park Cancer Institute class: OTHER briefSummary: To collect samples and information from patients who will be undergoing standard of care neoadjuvant treatment with either FOLFIRINOX or Gemcitabine + Nab-paclitaxel.

The information collected will be used to determine if there are any "biomarkers" in your blood or tumor tissue that, when compared to your response to the neoadjuvant treatment, could be used to choose the best treatment option for future patients with similar biomarkers. conditions: Pancreatic Ductal Adenocarcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: Blood sample measure: Retrospective prediction of pCR in resectable patients measure: Retrospective prediction of pCR in borderline resectable patients measure: Survival status measure: RECIST 1.1 response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Roswell Park Comprehensive Cancer Center status: RECRUITING city: Buffalo state: New York zip: 14263 country: United States lat: 42.88645 lon: -78.87837 hasResults: False

 nctId: NCT06320704 id: 01067485392 briefTitle: Occlusal Balance Effect on Mandibular Bone Density by Using Fractal Analysis in Complete Denture Patients (Split-Mouth Study) overallStatus: RECRUITING date: 2024-03-21 date: 2024-09-21 date: 2024-09-21 date: 2024-03-20 date: 2024-03-20 name: Badr University class: OTHER briefSummary: Although the number of individuals who are edentulous is declining, a sizable fraction still needs a complete denture for their oral rehabilitation.Tooth loss is an issue in public health that determines quality of life since it is linked to socioeconomic, physiological, and psychological aspects. In patients who are completely edentulous, dental implants have been viewed as a favorable choice for rehabilitation. conditions: Bone Density studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 16 type: ESTIMATED name: Digital occlusal adjustment using Occulosense digital device measure: Bone Density measure: Bone Density measure: Bone Density measure: Bone Density sex: MALE minimumAge: 45 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Badr University in Cairo status: RECRUITING city: Cairo state: القاهرة country: Egypt name: Shady Elnaggar role: CONTACT email: shady.mahmoud@buc.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06320691 id: BezmialemVU 1 briefTitle: General vs Spinal Anesthesia for Total Joint Arthroplasty-Anterior Approach: A Single-Institution Observational Study overallStatus: COMPLETED date: 2014-01-10 date: 2017-01-10 date: 2017-05-25 date: 2024-03-20 date: 2024-03-20 name: Bezmialem Vakif University class: OTHER briefSummary: The study compares the effects of various anesthetic techniques on anterior approach total hip arthroplasty results retrospectively conditions: Arthroplasty Complications conditions: Anesthesia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 437 type: ACTUAL name: Total Hip Arthroplasty name: General Anesthesia name: Spinal Anesthesia measure: Mean intraoperative estimated blood loss measure: mean duration of surgery measure: length of hospital stay measure: stem subsidence measure: stem varus/valgus degrees measure: acetabular abduction sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bezmialem Vakif University city: Istanbul zip: 34140 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06320678 id: Aysun Acun 5 briefTitle: Parenteral Drug Administration Training for Nursing Students overallStatus: RECRUITING date: 2024-02-29 date: 2024-03-20 date: 2024-04 date: 2024-03-20 date: 2024-03-20 name: Bilecik Seyh Edebali Universitesi class: OTHER briefSummary: This study aims to evaluate the effect of blended self-directed learning with concept mapping on the level of knowledge regarding parenteral drug administration in nursing students. With out-of-class, online, interactive teaching methods, a memorable learning away from complex structure is aimed. conditions: Nursing Education studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 110 type: ESTIMATED name: Nursing Students Education measure: Students' knowledge level after blended learning method sex: ALL minimumAge: 17 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Bilecik Şeyh Edebali University status: RECRUITING city: Bilecik zip: 11000 country: Turkey name: Aysun Acun, PhD role: CONTACT phone: +905072104506 email: aysun.acun@bilecik.edu.tr lat: 40.14192 lon: 29.97932 hasResults: False

 nctId: NCT06320665 id: 2024PI003 briefTitle: Assessment of Sagittal and Vertical Pattern in Correlation With Third Molar Inclusion : A 3D CBCT Analysis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-30 date: 2025-09-30 date: 2024-03-20 date: 2024-04-24 name: Central Hospital, Nancy, France class: OTHER briefSummary: The objective is to compare the sagittal and vertical skeletal parameters of patients with an impacted third molar.

Patients will be analyzed according to their skeletal characteristics: skeletal class (sagittal direction) and facial skeletal typology (vertical direction).

The inclusion characteristics of third molars will also be analyzed, to see the links between typology and inclusion. The principal hypothesis is no significant difference in third molar inclusion patterns in relation to skeletal divergence. conditions: Impacted Third Molar Tooth studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 80 type: ESTIMATED name: Radiographic measurement measure: Distance between the occlusal plane and the second molar measure: Angle of the third molar sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06320652 id: CUHospital briefTitle: Implementation and Evaluation of Telemedicine in Cardiac Rehabilitation overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2027-08-31 date: 2024-03-20 date: 2024-04-19 name: Copenhagen University Hospital, Hvidovre class: OTHER name: Hvidovre University Hospital briefSummary: The overall aim is to develop and test the effect of a tailored patient and family focused cardiac tele rehabilitation intervention on health literacy by comparing it to standard care. Furthermore, to evaluate health-related quality of life, family support, and how the patients experience the communication and relationship with outpatient clinic nurses. conditions: Cardiac Rehabilitation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: First, all willing patients who are offered cardiac rehabilitation will comprise the control group. Following a period of implementing the adapted co-created cardiac telerehabilitation intervention. Patients in the control group have access to standard care at the cardiac outpatient clinic program comprising standard center-based cardiac rehabilitation. Patients in the intervention group will, in addition to standard care, be offered an individually tailored family-focused cardiac telerehabilitation developed through a co-creative process. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 140 type: ESTIMATED name: Cardiac telerehabilitation (video consultation and home monitoring) measure: Health Literacy Questonnaire measure: The European Quality of life five dimensions questionnaire measure: The Iceland-Family Perceived Support Questionnaire measure: The eHealth Literacy Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06320639 id: UGustaveEiffel briefTitle: DRIVing Simulator and People With NeuroCognitive Disorders acronym: DRIVS-NCD overallStatus: RECRUITING date: 2023-10-03 date: 2026-10-10 date: 2026-10-10 date: 2024-03-20 date: 2024-03-20 name: University Gustave Eiffel class: OTHER name: Hospices Civils de Lyon briefSummary: The ageing of the population is leading to an increasing number of older drivers on the roads. At the same time, the proportion of older people with pathological ageing and neurocognitive disorders (NCD) is increasing. In terms of road safety, this raises the question of whether these drivers should continue to drive or not. People with NCDs may not be aware of the presence, extent and progression of their cognitive impairment and the impact it can have on daily life, including driving.

Despite their loss of autonomy and medical advice, 22% of people with major NCD continue to drive. In addition, the presence of minor NCD also puts people at a higher risk of road accidents.

However, several studies demonstrated that an NCD does not lead to a systematic and immediate impairment of driving ability and abruptly stopping driving leads to health problems, such as the risk of depression and greatly reduces quality of life.

It is therefore relevant to focus research on driving with people with NCD in order to have a reliable indicator of the person's abilities and the impact of their cognitive impairment on driving activity. The proposed study seeks to meet this need by studying the performance of people with NCD on a driving station (mini-simulator) while assessing their ability to evaluate their performance.

To achieve this goal, people with NCDs will perform tasks on a driving simulator. In addition, after each task on the driving simulator, they will answer questions about how they evaluate their own driving. Two assessors will observe the participants' driving and will estimate their driving performance. By comparing the driver's self-assessment with the assessors' assessment, an "awareness score of driving ability" will be calculated to determine whether the driver correctly assessed his or her performance.

Another project already underway aims to collect similar data from people without a diagnosis of NCDs (control group).

The principal objective of the present study is to compare the driving performance in a simulator and the awareness of driving ability of people with NCDs with those of a control group. Secondary objectives are :

1. to measure driving performance in a simulator and awareness of driving abilities (i.e. self-assessment skills) of people with NCDs.
2. to analyse driving performance and awareness of driving abilities according to the diagnosis and severity of the disorder (i.e. minor or major neurocognitive disorders).
3. to establish a methodology to identify a driver at risk of dangerous driving.

It is mainly an exploratory study however some hypotheses can be made :

* The driving performance and awareness of driving skills of people with NCDs are poorer compared to those of older, control individuals.
* Individuals' driving performance and awareness of driving ability are lower in the presence of major NCDs compared to minor NCDs. conditions: Neurocognitive Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 150 type: ESTIMATED measure: Awareness score of driving ability measure: Driving performance variables measured by the driving simulator sex: ALL minimumAge: 50 Years maximumAge: 95 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital des Charpennes status: RECRUITING city: Villeurbanne zip: 69100 country: France name: Marion Giroux, PhD role: CONTACT phone: 0472432372 email: marion.giroux@chu-lyon.fr lat: 45.76667 lon: 4.88333 hasResults: False

 nctId: NCT06320626 id: 22-571 briefTitle: Pharmacokinetic-guided Dosing of Emicizumab acronym: DosEmi overallStatus: RECRUITING date: 2022-09-08 date: 2026-03 date: 2026-08 date: 2024-03-20 date: 2024-03-20 name: Kathelijn Fischer class: OTHER name: Erasmus Medical Center name: Amsterdam University Medical Center name: Leiden University Medical Center name: Radboud University Medical Center name: Maastricht University Medical Center name: University Medical Center Groningen name: HagaZiekenhuis name: Dutch Society of Haemophilia Patients briefSummary: The goal of this multicentre, prospective, open-label, cross-over clinical study is to determine whether individualized PK-guided dosing of emicizumab is non-inferior to conventional dosing of emicizumab in the prevention of bleeding in congenital haemophilia A patients. conditions: Hemophilia A With Inhibitor conditions: Hemophilia A Without Inhibitor conditions: Hemophilia A, Severe conditions: Adolescent conditions: Child conditions: Adult studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: * PK-guided dosing - Intervention group (12M): Subjects with emicizumab concentration of ≥ 40 μg/mL will receive individualized PK-guided dose reduction of emicizumab targeted at a Ctrough of 30μg/mL. The validated population PK model is based on published population PK and PK/PD modelling studies. (9,10,15)
* PK-Guided dosing - Non-intervention group (12M): Subjects with emicizumab concentration of 25-39 μg/mL will continue on their current dose regimen and will be followed according to the same assessment schedule as the Intervention Group. Only subjects with emicizumab plasma concentration \< 25 μg/mL will be adjusted in dosing regimen according to local protocol. These subjects will be followed for selective safety data only. primaryPurpose: TREATMENT masking: NONE count: 95 type: ESTIMATED name: Emicizumab - PK-guided dose reduction name: Emicizumab - Dosis continuation group name: Emicizumab - Dose adjustment group measure: Proportion of patients without treated bleeds measure: Proportion of patients without treated bleeds measure: Proportion of patients without spontaneous joint- or muscle bleeds measure: Annualized bleeding rate (ABR) of treated bleeds, including joint bleeds and sport-induced bleeds measure: To compare cost-effectiveness between conventional dosing and individualized PK-guided dosing of emicizumab measure: To assess the cumulative number of coagulation factor (sc. and/or iv.) of per year. measure: To assess the performance of the population PK model measure: To investigate whether direct joint health remains stable measured by physical examination when switching to lower-dosed emicizumab compared to conventional treatment measure: To investigate whether direct joint health remains stable measured by ultrasound when switching to lower-dosed emicizumab compared to conventional treatment measure: To investigate if indirect joint health, as measured by biomarkers, remains stable when switching to lower doses of emicizumab compared to conventional treatment. measure: To investigate if indirect joint health, as measured by biomarkers, remains stable when switching to lower doses of emicizumab compared to conventional treatment. measure: To investigate whether Health Related Quality of Life (HR-QoL) are similar in patients receiving conventional dosing compared with PK-guided dosing of emicizumab. measure: To investigate whether Health Related Quality of Life (HR-QoL) are similar in patients receiving conventional dosing compared with PK-guided dosing of emicizumab. measure: To investigate whether sports participation are similar in patients receiving conventional dosing compared with PK-guided dosing of emicizumab. measure: To investigate whether thrombin generation parameters can be used as a pharmacodynamic (PD) biomarker for emicizumab treatment efficacy. measure: To assess and monitor pain during emicizumab administration sex: MALE minimumAge: 1 Year stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Radboud University Medical Center status: RECRUITING city: Nijmegen state: Gelderland zip: 6525 GA country: Netherlands name: Saskia Schols, Dr, MD role: CONTACT phone: +310 24 361 8823 email: Saskia.Schols@radboudumc.nl name: Saskia Schols, Dr, MD role: SUB_INVESTIGATOR lat: 51.8425 lon: 5.85278 facility: Maastricht University Medical Center status: RECRUITING city: Maastricht state: Limburg country: Netherlands name: Floor Moenen, Dr, MD role: CONTACT phone: +31433876543 email: floor.moenen@mumc.nl name: Floor Moenen, Dr, MD role: SUB_INVESTIGATOR lat: 50.84833 lon: 5.68889 facility: Amsterdam University Medical Center status: RECRUITING city: Amsterdam state: Noord-Holland zip: 1105 AZ country: Netherlands name: Michiel Coppens, Dr, MD role: CONTACT phone: +31(0)20 566 5964 email: m.coppens@amsterdamumc.nl name: Michiel Coppens, Dr, MD role: SUB_INVESTIGATOR lat: 52.37403 lon: 4.88969 facility: HagaZiekenhuis status: RECRUITING city: Den Haag state: Zuid-Holland zip: 2545 CH country: Netherlands name: Paula Ypma, MD role: CONTACT phone: +310702102620 email: haematologie@hagaziekenhuis.nl name: Paula Ypma, MD role: SUB_INVESTIGATOR lat: 52.07667 lon: 4.29861 facility: Leids Universitair Medisch Centrum status: RECRUITING city: Leiden state: Zuid-Holland zip: 2300 RC country: Netherlands name: Paul den Exter, Dr, MD role: CONTACT phone: +31 (0)71 526 1850 email: p.l.den_exter@lumc.nl name: Paul den Exter, Dr, MD role: SUB_INVESTIGATOR lat: 52.15833 lon: 4.49306 facility: Erasmus University Medical Center status: RECRUITING city: Rotterdam state: Zuid-Holland zip: 3000CA country: Netherlands name: Marjon Cnossen, Dr., MD role: CONTACT phone: +31107040113 email: m.cnossen@erasmusmc.nl name: Marjon Cnossen, Dr. MD role: SUB_INVESTIGATOR lat: 51.9225 lon: 4.47917 facility: University Medical Center Groningen status: RECRUITING city: Groningen zip: 9700 RB country: Netherlands name: Louise Hooimeijer, MD role: CONTACT phone: +310-503612740 email: h.l.hooimeijer@umcg.nl name: Louise Hooimeijer, MD role: SUB_INVESTIGATOR lat: 53.21917 lon: 6.56667 facility: University Medical Center Utrecht status: RECRUITING city: Utrecht country: Netherlands name: Kathelijn Fischer, Dr, MD role: CONTACT phone: +31887558450 email: K.Fischer@umcutrecht.nl name: Konrad van der Zwet, MD role: CONTACT phone: +31650124691 email: dosemi@umcutrecht.nl name: Kathelijn Fischer, Dr, MD role: PRINCIPAL_INVESTIGATOR name: Konrad van der Zwet, MD role: SUB_INVESTIGATOR name: Lize F.D. van Vulpen, Dr, MD role: SUB_INVESTIGATOR name: Roger E.G. Schutgens, Prof, MD role: SUB_INVESTIGATOR name: Paul van der Valk, MD role: SUB_INVESTIGATOR name: Karin P.M. van Galen, Dr, MD role: SUB_INVESTIGATOR name: Nanda Uitslager, Msc role: SUB_INVESTIGATOR lat: 52.09083 lon: 5.12222 hasResults: False

 nctId: NCT06320613 id: KYLL20240117-2 briefTitle: Effect of Implementing Snap-needle Therapy Combined With Ginger Paste During Anesthesia Recovery on the Recovery of Gastrointestinal Function After Gynecologic Laparoscopy overallStatus: RECRUITING date: 2024-03-20 date: 2024-09-20 date: 2024-09-20 date: 2024-03-20 date: 2024-03-20 name: Weifang Medical University class: OTHER name: Weifang People's Hospital briefSummary: The aim of this study was to investigate the effect of implementing snap-needle therapy combined with ginger paste during anesthesia recovery on the recovery of gastrointestinal function after gynecological laparoscopy. conditions: Gastrointestinal Motility conditions: Postoperative Nausea and Vomiting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Acupuncture therapy name: Ginger Acupuncture Point Patch measure: Postoperative nausea and vomiting measure: Postoperative nausea and vomiting measure: Postoperative nausea and vomiting measure: Postoperative nausea and vomiting measure: Postoperative nausea and vomiting measure: Postoperative nausea and vomiting measure: Abdominal distention measure: Abdominal distention measure: Abdominal distention measure: Abdominal distention measure: Abdominal distention measure: Abdominal distention measure: Time to first flatus measure: Postoperative pain response measure: Postoperative pain response measure: Postoperative pain response measure: Postoperative pain response measure: Postoperative pain response measure: Postoperative pain response measure: Consumption of postoperative analgesic measure: Consumption of postoperative rescue antiemetic measure: Time to first defecation sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lin Cheng status: RECRUITING city: Weifang state: Shandong zip: 261000 country: China name: Lin Cheng, B.S role: CONTACT phone: 17667404256 email: 1318216353@qq.com lat: 36.71 lon: 119.10194 hasResults: False

 nctId: NCT06320600 id: PDC briefTitle: Precision Medicine of Diabetes Program in China acronym: PDC overallStatus: RECRUITING date: 2023-07-01 date: 2028-12 date: 2028-12 date: 2024-03-20 date: 2024-03-20 name: Second Xiangya Hospital of Central South University class: OTHER briefSummary: The prevalence of diabetes has been increasing year by year. According to the International Diabetes Federation (IDF) statistics in 2021, the global number of people with diabetes has reached 537 million. The patient population is large and heterogeneous, and precise diagnosis and treatment of diabetes patients have been a focus of attention. The objective of this study is to clarify the current status of precision classification and diagnosis of diabetes patients through retrospective and prospective cohort studies, and to establish a model for precision classification and diagnosis of diabetes, improving the accuracy of diabetes classification and diagnosis; based on big data of precision medicine for diabetes patients and follow-up cohorts, to establish precise diagnostic, therapeutic, and predictive methods for diabetes; and through multi-omics data analysis, to explore the potential pathogenesis of diabetes, explaining the heterogeneity of patients, and guiding individualized treatment for patients. conditions: Diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 120000 type: ESTIMATED name: no intervention measure: The currency analysis of diabetes classification measure: To establish a model for predicting diabetic retinopathy measure: To establish a model for predicting diabetic kidney disease measure: To establish a model for predicting diabetic neuropathy measure: To establish a model for hypoglycemic therapy sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: the Second Xiangya Hospital status: RECRUITING city: Changsha state: Hunan zip: 410010 country: China name: Shuting Yang role: CONTACT phone: 15200863137 email: yang_shting@163.com lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06320587 id: AEŞH-EK1-2023-508 briefTitle: The Effect of Kangaroo Care on Parents' Perceived Parenting Self-Efficacy, Infant Attachment and Newborn Vital Signs overallStatus: RECRUITING date: 2024-02-01 date: 2024-03-30 date: 2024-05-30 date: 2024-03-20 date: 2024-03-20 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: This study was planned to determine the effect of kangaroo care applied by parents of premature newborns in the neonatal intensive care unit on the newborn's vital signs, perceived parenting self-efficacy level and attachment to the baby. conditions: Kangaroo Care conditions: Fathers conditions: Mother-Infant Interaction conditions: Premature Infant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Kangaroo care practice by both mother and father name: Kangaroo care practice only mother measure: Mother-To-Infant Bonding Scale measure: Perceived Mother Parenting Self-Efficacy Scale measure: Postnatal Paternal-Infant Attachment Questionnaire measure: Perceived Father Parenting Self-Efficacy Form measure: Physiological parameters of the premature infant: peak heart rate (BPM) measure: Physiological parameters of the premature infant: oxygen saturation (%) measure: Physiological parameters of the premature infant: body temperature (°C) measure: Physiological parameters of the premature infant:Respiration rate (RPM) sex: ALL minimumAge: 28 Weeks maximumAge: 37 Weeks stdAges: CHILD facility: Ankara Etlik City Hospital status: RECRUITING city: Ankara zip: 06170 country: Turkey name: Gönül Kurt, Assoc.prof. role: CONTACT phone: 90(312)304 phoneExt: 3934 email: gonul.kurt@sbu.edu.tr name: Meryem Büşra Borazan role: CONTACT email: busrabrzn.bb@gmail.com name: Meryem Büşra Borazan role: SUB_INVESTIGATOR name: Gönül Kurt, Assoc.prof. role: PRINCIPAL_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06320574 id: 2023-16880 briefTitle: Nurses' Competence in Gastric Ultrasound acronym: SKILLS-1 overallStatus: NOT_YET_RECRUITING date: 2024-03-14 date: 2024-04-20 date: 2024-08-01 date: 2024-03-20 date: 2024-03-20 name: Radboud University Medical Center class: OTHER briefSummary: The goal of this observational cohort study is to investigate gastric ultrasound skills in surgical nurses. The main question it aims to answer is:

• how much training is required for surgical nurses to obtain competency in performing gastric ultrasound.

Participants will follow a training involving

* theoretical background using e-learning, picture library and lecture
* practical skill development in an interactive hands-on workshop on live models directed by expert gastric ultrasonographer
* and formative assessments during training sessions scanning healthy volunteers by participants and examiners (expert gastric ultrasonographers). conditions: Gastric Content conditions: Healthy Volunteers studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 8 type: ESTIMATED measure: Number of required training sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06320561 id: 23485_StrIMuC12 briefTitle: Muscular Changes in the First 12 Weeks After Stroke. acronym: StrIMuC12 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-01 date: 2027-05 date: 2024-03-20 date: 2024-03-20 name: Vrije Universiteit Brussel class: OTHER name: University Ghent name: Research Foundation Flanders briefSummary: The investigators will use 3D freehand ultrasound to investigate changes in muscle morphology of the paretic m. rectus femoris and m. gastrocnemius medialis during the first 3 months after stroke. Additionally, 2D ultrasound and surface EMG will be synchronized to examine muscle activation and morphological changes resulting from this activation. Clinical tests will be conducted on the same test occasions to objectify lower limb impairment and gait recovery. As such, the investigators will explore the relationship between the muscle specific changes and functional recovery. conditions: Stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Longitudinal prospective cohort study measure: Functional Ambulation Categories (FAC)-score measure: Muscle volume measure: Cross-sectional area (CSA) measure: Physiological cross-sectional area (pCSA) measure: Muscle tickness measure: Fascicle length measure: Muscle length measure: Tendon length measure: Pennation angle measure: Echo Intensity measure: Dynamic muscle morphology measure: Change in cross-sectional area measure: Change in fascicle length measure: Average root mean square (RMS) measure: Peak root mean square (RMS) measure: Muscle strength measure: Spasticity measure: Lower limb motor impairment measure: Spatiotemporal gait parameters measure: Gait quality measure: TWIST-score measure: Knee extension strength measure: Balance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06320548 id: 0724/2018 briefTitle: The Efficacy of Preoperative Low-residue Diet on Postoperative Ileus Following Cesarean Section overallStatus: COMPLETED date: 2018-10-01 date: 2020-11-30 date: 2020-12-02 date: 2024-03-20 date: 2024-03-20 name: University of Roma La Sapienza class: OTHER briefSummary: The aim of the present study was to evaluate the efficacy of preoperative low-residue diet on postoperative ileus in women undergoing elective cesarean section. It is a surgeon-blind, randomized controlled trial enrolling pregnant women at ≥39 weeks of gestation undergoing elective cesarean section. Patients were preoperatively randomized to receive either low-residue diet (arm A) or free diet (arm B) starting from three days before surgery. The primary outcome was the postoperative ileus at 24 hours after surgery. The secondary outcomes were the postoperative pain (assessed through VAS scale), the quality of the surgical field (scored using a 5-point scale, from poor to excellent), postoperative complications, and the length of hospital stay. Perioperative data were collected and compared between groups. conditions: Cesarean Section Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 166 type: ACTUAL name: Low-residue diet name: Free diet measure: Number of participants who have passage of flatus within the first 24 hours after caesarean section. measure: Postoperative pain measure: Postoperative complications measure: Quality of the surgical field sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sapienza University of Rome city: Rome country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06320535 id: VAC096 briefTitle: A Phase 1 Study to Assess an Escalating Dose, Multi-prime Vaccination Schedule of R21/Matrix-M™ overallStatus: RECRUITING date: 2024-04 date: 2026-04 date: 2027-04 date: 2024-03-20 date: 2024-03-20 name: University of Oxford class: OTHER name: Bill and Melinda Gates Foundation name: University Hospitals Bristol and Weston NHS Foundation Trust briefSummary: This is a phase I clinical study that aims to assess the safety and immunogenicity of a novel, escalating dose regimen of R21/Matrix-M™ in healthy, malaria-naïve adults. conditions: Malaria,Falciparum studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 36 type: ESTIMATED name: R21/Matrix M™ (Group 1) name: R21/Matrix M™ (Group 2) name: R21/Matrix M™ (Group 3) name: Fine needle aspiration (FNA) measure: To compare the safety of R21/Matrix-M™ administered in an escalating dose, multi prime vaccination schedule with a standard prime-boost regimen in healthy UK adults measure: To compare the safety of R21/Matrix-M™ administered in an escalating dose, multi prime vaccination schedule with a standard prime-boost regimen in healthy UK adults measure: To compare the humoral immunogenicity of R21/Matrix-M™ administered in an escalating dose, multi-prime vaccination schedule with a standard prime-boost regimen in healthy UK adults measure: To assess the relationship between vaccination schedule and humoral immune response in participants vaccinated with R21/Matrix-M™ administered in escalating dose, multi-prime vaccination schedules compared with a standard prime-boost regimen sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Centre for Clinical Vaccinology and Tropical Meducine, Churchill Hospital, University of Oxford status: RECRUITING city: Oxford state: Oxfordshire zip: OX3 7LE country: United Kingdom name: Volunteer Recruitment Co-ordinator role: CONTACT phone: 01865611386 email: vaccinetrials@ndm.ox.ac.uk lat: 51.75222 lon: -1.25596 facility: University Hospitals Bristol and Weston NHS Foundation Trust status: NOT_YET_RECRUITING city: Bristol zip: BS2 8HW country: United Kingdom name: Rajeka Lazarus, DPhil FCRPath role: CONTACT email: rajeka.lazarus@uhbristol.nhs.uk name: Rajeka Lazarus, DPhil FRCPath role: PRINCIPAL_INVESTIGATOR lat: 51.45523 lon: -2.59665 hasResults: False

 nctId: NCT06320522 id: R82053/RE002 briefTitle: Exogenous Ketosis in a Fed and a Fasted State overallStatus: RECRUITING date: 2023-02-15 date: 2024-05 date: 2024-05 date: 2024-03-20 date: 2024-03-20 name: University of Oxford class: OTHER briefSummary: The kinetics of circulating βHB following ingestion of the ketone monoester are dependent on several variables that determine the balance between appearance into, and disappearance from, the bloodstream. These dynamics have been well characterised in fasted humans but in the real world the ketone monoester is likely to be ingested in a fed state, pertinently within athletic spheres consumption would proceed a substantial high-carbohydrate meal. Within this, it is unclear how metabolism under exogenous ketosis might be affected in a fed versus fasted state.

This four-arm crossover study looks to characterise the relationship between feeding status, βHB pharmacokinetics, and resting metabolism.

As exogenous ketosis is known to reduce circulating glucose levels, this study will also explored if hepatic metabolism - for example, de novo lipogenesis - might consequently be altered, with implications for metabolic disease states such as Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and type II diabetes.

Participants will be asked to consume either the ketone monoester drink or a placebo drink when fasted and when having previously consumed a meal. conditions: Ketosis conditions: Exogenous Ketosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 12 type: ESTIMATED name: Ketone Monoester name: Placebo measure: Plasma β-hydroxybutyrate (βHB) kinetics measure: Plasma glucose kinetics measure: Postprandial de novo lipogenesis (DNL) measure: Plasma biochemistry measure: Very low-density lipoprotein-triglyceride (VLDL-TG) fatty acid composition measure: Breath acetone measure: Urine volume measure: Urine composition measure: Indirect calorimetry measure: Subjective measures of appetite measure: Subjective measures of gastrointestinal distress sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oxford Centre for Diabetes, Endocrinology, and Metabolism (OCDEM) status: RECRUITING city: Oxford state: Oxfordshire zip: OX3 7LE country: United Kingdom name: Leanne Hodson, PhD role: CONTACT phone: 01865 857224 email: leanne.hodson@ocdem.ox.ac.uk name: Leanne Hodson, PhD role: PRINCIPAL_INVESTIGATOR name: Adam Isherwood, MSc role: SUB_INVESTIGATOR lat: 51.75222 lon: -1.25596 hasResults: False

 nctId: NCT06320509 id: 49RC23_0417 briefTitle: Interest of Urinary Oxygen Partial Pressure (PO2u) in Predicting the Onset or Recovery of Acute Renal Failure During Shock States - OXYpi Study acronym: OXYpi overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-07 date: 2024-03-20 date: 2024-03-20 name: University Hospital, Angers class: OTHER_GOV briefSummary: Shock state is defined as an acute, life-threatening, circulatory failure with impaired tissue oxygenation (or tissue hypoxia). The cause of the shock state can be septic, anaphylactic, hypovolemic or cardiogenic. Its management is based on etiological treatment and replacement of organ failures. Acute kidney injury (AKI) may be lead by renal hypoxia. Acute kidney injury is frequent in patients admitted to intensive care unit (ICU) and associated with an increased mortality. Serum creatinine is the reference biological marker in the diagnosis of Acute kidney injury. However, its use is limited by a delayed increase in plasma creatinine level in relation to the causal renal agression, at a time when renal tissue damage may already be established. Thus, the identification of a biological marker making it possible to estimate renal hypoxia continuously during a shock could allow us to identify early a situation at risk of evolving into Acute kidney injury.

The renal medulla is vulnerable to tissue hypoxia with a risk of acute tubular necrosis. As in situ measurement of mPO2 is not possible in current practice in humans, several studies have shown a positive correlation between variations in mPO2/uPO2 and occurence of Acute kidney injury. In humans, studies have shown a significant association between the reduction in uPO2 in cardiac surgeries and the occurrence of postoperative Acute kidney injury. The aim of the study is to describe the association between uPO2 values and the onset of Acute kidney injury and/or the ocurrence of early recovery of renal function after Acute kidney injury. Any patient in shock (group A) or without shock and requiring urinary catheterization as part of treatment (group B) admitted to the Medical-Intensive Care Unit of Angers University Hospital is eligible for inclusion. After inclusion, a continuous uPO2 measuring probe is introduced with the placement of the urinary probe. uPO2 is collected continuously for the first 5 days of admission or until discharge from intensive care or removal of the urinary catheter. uPO2 is also measured by a gasometry on a urine sample on a multi-daily basis. Serum creatinine is collected every 12 hours (twice a day) and diuresis every two hours for 5 days. conditions: Shock Circulatory studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 55 type: ESTIMATED name: Continuous measurement of uPO2 (both groups) measure: A - For patients without acute kidney injury at inclusion, the occurence of acute kidney injury and its severity according to the KDIGO criteria measure: B - For patients with acute kidney injury occurring during the first 3 days following inclusion, early recovery is defined by the return to pre-shock renal function 48 hours from the start of acute kidney injury measure: In patients in group A, assess the association between uPO2 variation and acute kidney injury, defined by KDIGO criteria, in different subgroups (septic shock, sepsis without norepinephrine, non-septic shock). measure: In patients in group A with newly occured acute kidney injury, assess the association between uPO2 variation and recovery of acute kidney injury in different subgroups (septic shock, sepsis without norepinephrine, non-septic shock). measure: In patients in group A, assess the evolution of uPO2 during the first 5 days in patients with and without sepsis measure: Describe the variation of uPO2 according to evolution of Mean Arterial Pressure and cardiac output in the subgroup of patients who received fluid expansion measure: Describe the variation of uPO2 according to evolution of Mean Arterial Pressure and cardiac output in the subgroup of patients who received blood transfusion measure: In patients with need of increasing Mean Arterial Pressure by increase of norepinephrine doses, describe the evolution of uPO2 according to Mean Arterial Pressure evolution. measure: In patients with need of introduction or increase of dobutamine, describe the evolution of uPO2 according to cardiac output or Mean Arterial Pressure evolution. measure: Evaluation the correlation between uPO2 assessed by Oxylite Pro® device and urinary gasometry. measure: In patients without shock, describe the evolution of uPO2 during the first 5 days. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital of Angers city: Angers zip: 49933 country: France name: Nicolas Fage, PhD role: CONTACT lat: 47.46667 lon: -0.55 hasResults: False

 nctId: NCT06320496 id: IRR-FLAVIGNY-2021-2 briefTitle: Evaluation of the Effect of a Physical Activity Recovery Stay overallStatus: RECRUITING date: 2022-03-22 date: 2024-12 date: 2025-03 date: 2024-03-20 date: 2024-04-09 name: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est class: OTHER briefSummary: A WHO study in 2020 revealed that 81% of adolescents (aged 11-17) do not respect the recommendation of one hour of moderate physical activity per day. In the context of disability, many factors impose limits on physical activity. While the pathology itself induces limitations and restrictions (prolonged sitting time, assisted movement, etc.), organizational constraints also apply to both children and parents, who have to divide their time between work, school and therapeutic care, which is sometimes numerous and varied over the course of a single week. These limitations generate stress and fatigue, and prolonged sedentary periods lead children with chronic illnesses, rare diseases or disabilities into a process of physical deconditioning. The accumulation of sedentary time is detrimental to cardiovascular and metabolic health.

To combat this deconditioning, the 2008 National Physical Activity and Sport Plan (PNAPS) sets out the main guidelines for treatment and implementation. The plan explains that "for patients with chronic illnesses, rare diseases or disabilities, the aim is to encourage care and guidance towards Adapted Physical Activity (APA). The attending physician will be able to identify local therapeutic education programs, rehabilitation services and "sport-santé" offers, to improve access for these patients to supervised local programs". In addition, the plan suggests "developing APA programs in healthcare establishments to enable people with chronic illnesses, rare diseases or disabilities to access health education incorporating practical sessions".

In line with this plan, an exercise reconditioning program has been set up at our facility. This three-month stay includes children with a variety of pathologies, but with a common feature of physical deconditioning. conditions: Children With Cerebral Palsy conditions: Children With Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Diagnoform test score measure: KidScreen52 quality-of-life scale score. measure: Impedance measurement measure: Exercise test on ergometer measure: Anamnesis measure: 6-minute walk test measure: Energy expenditure index measure: Gluteal bridge measure: Shirado test measure: Sorensen test measure: Timed Up and Down Stairs (TUDS) test measure: Floor survey test measure: Mini Bestest : Each of the 14 tests is graded from 0 to 2. "0" represents the lowest functional level and "2" the highest functional level. Maximal score : 28. measure: The Canadian Occupational Performance Measure measure: A motivational questionnaire sex: ALL minimumAge: 8 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Institut Régional de Médecine Physique et de Réadaptation status: RECRUITING city: Nancy zip: 54000 country: France name: Jonathan Pierret, PhD role: CONTACT phone: +33 3 82 52 6761 email: jonathan.pierret@ugecam.assurance-maladie.fr lat: 48.68439 lon: 6.18496 hasResults: False

 nctId: NCT06320483 id: BT-01-23 briefTitle: Evaluation of the Effectiveness and Safety of Vibro-acoustic Pulmonary Therapy (VAPT) in Complex Therapy for Acute Respiratory Failure of Mixed Type I-II Stages in Comparison With Percussion Massage in Cardiac Surgical Patients in the Early Postoperative Period overallStatus: RECRUITING date: 2023-09-20 date: 2024-09 date: 2024-09 date: 2024-03-20 date: 2024-03-20 name: Bark Technology LLP class: INDUSTRY briefSummary: The goal of this observational study is to evaluate the effectiveness and safety of vibro-acoustic pulmonary therapy (VAPT) in complex therapy for the acute respiratory failure of mixed type I-II stages in comparison with percussion massage in cardiac surgical patients in the early postoperative period. conditions: Cardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect) studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 310 type: ESTIMATED name: Vibroacoustic device BARK VibroLUNG measure: Partial pressure of oxygen (PaO2) measure: Partial pressure of carbon dioxide (PaCO2) measure: Blood oxygen saturation level (SpO2) on pulse oximeter (peripheral capillary oxygenation) measure: Ratio of peripheral arterial oxygen saturation(SaO2) to the inspired fraction of oxygen FiO2 measure: Ratio of venous saturation (SvO2) to the inspired fraction of oxygen FiO2 measure: ROX Index measure: P/F index (ratio of arterial blood PO2 to oxygen fraction) measure: pH of blood measure: BE (base excess) of blood measure: CBC indicators (hemoglobin) measure: CBC indicators (hematocrit) measure: CBC indicators (platelets) measure: Coagulogram indicators (prothrombin time) measure: Coagulogram indicators (prothrombin index) measure: Coagulogram indicators (international normalized ratio) measure: Coagulogram indicators (fibrinogen) measure: Coagulogram indicators (activated partial thromboplastin time) measure: Number of days spent in the high dependency unit (intensive care ward in the department) measure: Number of days in hospital measure: Number of days of O2 support measure: Proportion of patients with postoperative complications (pneumonia/atelectasis/pulmonary infiltration) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: JSC "National Research Cardiac Surgery Center" status: RECRUITING city: Astana country: Kazakhstan name: Makhabbat Sansyzbaeva role: CONTACT phone: +7(7172)703158 email: cardiacsurgery@heartcenter.kz name: Timur Sayranovich role: PRINCIPAL_INVESTIGATOR lat: 51.1801 lon: 71.44598 facility: State-owned public enterprise with the right of economic management "Atyrau Regional Cardiology Center" status: RECRUITING city: Atyrau country: Kazakhstan name: Marat Konysov role: CONTACT phone: +7(7122)50-69-26 email: cardiocenter@atyraumed.kz name: Zhangeldy Kadirov role: SUB_INVESTIGATOR lat: 47.11667 lon: 51.88333 facility: State-owned public enterprise with the right of economic management "Regional Cardiology Center" status: RECRUITING city: Oral country: Kazakhstan name: Aktilek Umirbaev role: CONTACT phone: + 7701 338 35 04 email: kardio-zko@mail.ru name: Daniyar Arenov role: SUB_INVESTIGATOR lat: 51.23333 lon: 51.36667 facility: State-owned public enterprise with the right of economic management "Pavlodar Regional Cardiology Center" status: RECRUITING city: Pavlodar country: Kazakhstan name: Gulzhanat Dzhakova role: CONTACT phone: +7(7182)39-08-00 email: info@cardiomedical.kz name: Inna Glowacka role: SUB_INVESTIGATOR lat: 52.28333 lon: 76.96667 facility: State-owned public enterprise with the right of economic management "East Kazakhstan Regional Hospital" status: RECRUITING city: Ust-Kamenogorsk country: Kazakhstan name: Erlan Burkutov role: CONTACT phone: +7(7232)25-60-34 email: vko_obl@mail.ru name: Olesya Subbotina role: SUB_INVESTIGATOR lat: 49.97143 lon: 82.60586 hasResults: False

 nctId: NCT06320470 id: HUM00231159a id: VMR2022-03 type: OTHER_GRANT domain: Michigan, State of, Licensing and Regulatory Affairs, Department of 573000 briefTitle: MIVetsCan: Can-Coach Trial (Phase 1) overallStatus: COMPLETED date: 2023-08-07 date: 2023-12-11 date: 2023-12-11 date: 2024-03-20 date: 2024-03-20 name: University of Michigan class: OTHER name: Michigan, State of, Licensing and Regulatory Affairs briefSummary: The goal of the MIVetsCan Can-Coach Trial is to pilot and modify a trial of four coaching sessions to help Veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms. conditions: Chronic Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 22 type: ACTUAL name: Educational Session measure: Patient Global Impression of Change (PGIC) score measure: Average satisfaction level of the cannabis coaching overall assessed from a single survey question on satisfaction. measure: Average helpfulness level of the cannabis coaching assessed from a single survey question on cannabis coaching. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06320457 id: 2024-00095 briefTitle: A Brief Case Management Intervention for People Involuntarily Admitted to a Psychiatric Hospital acronym: CARP overallStatus: NOT_YET_RECRUITING date: 2024-03-21 date: 2024-10-21 date: 2024-10-31 date: 2024-03-20 date: 2024-03-27 name: University of Lausanne Hospitals class: OTHER briefSummary: The goal of this clinical trial is to assess whether a brief case management intervention aimed at promoting personal recovery and reducing the negative effects of coercion among people involuntarily admitted to a psychiatric hospital would be well accepted by them, practically feasible and useful. The main questions it aims to answer are:

* Is the case management intervention acceptable and feasible?
* What are the preliminary effects of the case management intervention on patients' personal recovery and its sub-dimensions, as well as on their level of perceived coercion and their global satisfaction with hospital care?

Participants will be asked to take part in:

* the five sessions of the case management intervention;
* two evaluation sessions (pre and post-intervention);
* a final in-depth semi-structured interview (optional). conditions: Psychiatric Disorder conditions: Involuntary Psychiatric Hospitalization studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 36 type: ESTIMATED name: Brief case management intervention measure: Eligibility rate measure: Participation rate measure: Drop-out rate measure: Intervention dosage measure: Missing data rates measure: Number of unexpected adverse events measure: Participants' acceptance and degree of satisfaction measure: Implementation barriers and facilitating factors measure: Recovery Assessment Scale (RAS) measure: Empowerment Scale measure: Rosenberg Self-Esteem Scale (RSS) measure: The Paradox of Self-Stigma scale (PaSS-24) measure: Beck Hopelessness Scale (BHS) measure: WHOQOL-BREF measure: International Trauma Questionnaire (ITQ) measure: Coercion Ladder (CL) measure: Index of fairness and Index of effectiveness measure: Satisfaction with hospital care measure: Brief INSPIRE scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lausanne University Hospital city: Lausanne state: Canton Of Vaud zip: 1003 country: Switzerland name: Stéphane Morandi role: CONTACT phone: +41 21 3140050 email: stephane.morandi@chuv.ch name: Stéphane Morandi role: PRINCIPAL_INVESTIGATOR lat: 46.516 lon: 6.63282 hasResults: False

 nctId: NCT06320444 id: CRFSJ0297 briefTitle: Non-invasive Spinal, Cortical, and Sensorimotor Biomarkers in Motor Neurone Disease overallStatus: RECRUITING date: 2023-06-15 date: 2024-12-15 date: 2025-07-15 date: 2024-03-20 date: 2024-03-20 name: University of Dublin, Trinity College class: OTHER name: Motor Neurone Disease Association, UK name: Irish Research Council, IE name: Health Research Board, IE name: Research Motor Neurone, IE name: Thierry Latran Foundation, FR name: ALS Association, USA briefSummary: Substantial variability exists in the onset, and rate of degeneration across individuals with Motor Neurone Disease (MND) or Amyotrophic Lateral Sclerosis (ALS). This variability requires biomarkers that accurately classify and reliably track clinical subtypes as the disease progresses. Degeneration occurs in the brain and spinal cord, however, non-invasive diagnosis of spinal cord function remains highly challenging due to its unique alignment in spine. Disruption of complex spinal and cortical circuits that transmit and process neural signals for position sense and movement has not been adequately captured in the neurophysiological profiling of ALS patients. The overarching aim of this study is to reveal and quantify the extent of change in the sensorimotor integration and its potential contribution to network disruption in ALS. conditions: Motor Neuron Disease, Amyotrophic Lateral Sclerosis conditions: Motor Neuron Disease Progressive Spinal Muscle Atrophy conditions: Primary Lateral Sclerosis conditions: Multiple Sclerosis conditions: Postpoliomyelitis Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 240 type: ESTIMATED name: 232 Electrode Electrophysiology (EEG-ECG-EMG-EXG) measure: Biomarker of sensorimotor integration measure: Determination of the feasibility of sensorimotor signatures as reliable biomarkers of ALS measure: Non-invasive recording of the SC functional neuro-electric activity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Academic Unit of Neurology, Trinity College Dublin, The University of Dublin status: RECRUITING city: Dublin state: Leinster zip: Dublin 2 country: Ireland name: Orla Hardiman,, BSc MB BCh BAO MD FRCPI FAAN role: CONTACT phone: +353 1 896 4497 email: hardimao@tcd.ie name: Prabhav Mehra, BE MSc role: CONTACT phone: +3530894781347‬ email: mehrap@tcd.ie lat: 53.33306 lon: -6.24889 hasResults: False

 nctId: NCT06320431 id: ACT-WHEN-001 briefTitle: ACT-GLOBAL THROMBOLYSIS (ACT-WHEN-001) Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632 acronym: ACT-WHEN overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2030-09-30 date: 2030-12-31 date: 2024-03-20 date: 2024-04-25 name: University of Calgary class: OTHER name: The George Institute for Global Health, Australia briefSummary: This domain has a prospective, randomized, controlled, open-label, parallel group with blinded endpoint assessment (PROBE) design. Up to 4,000 patients with presumed acute ischemic stroke (AIS) will be followed for 90 days (or until death, if prior to 90 days). The end of the trial is defined as the date that all participants have completed their Day 90 assessment.

This domain aim is to efficiently, reliably, and simultaneously, determine the comparative effectiveness of intravenous thrombolysis (IVT) using standard-dose intravenous tenecteplase (0.25 mg/kg body weight), vs. low-dose intravenous tenecteplase (0.18 mg/kg body weight) in all patients who present to hospital with acute ischemic stroke and are considered for intravenous thrombolysis. In addition, this domain also seeks to study standard-dose intravenous tenecteplase (0.25 mg/kg body weight), vs. low-dose intravenous tenecteplase (0.18 mg/kg body weight) vs. no TNK upfront with rescue IA TNK if necessary (in those eligible for emergency EVT) and no TNK upfront in those who have taken DOACs during the preceding 24 hours. This domain therefore seeks to generate more robust randomized evidence to guide clinicians in their decisions over the balance of risks and treatment with intravenous thrombolysis with tenecteplase wherever such evidence is currently insufficient.

This domain will currently evaluate four research questions in relation to the use of IVT with tenecteplase:

1. In patients with recent (24 hours) intake of a standard-dose direct oral anticoagulant (DOAC), how should IVT be used? - Use standard-dose (0.25 mg/kg body weight) or low-dose tenecteplase (0.18 mg/kg) or not at all.
2. In patients planned to be treated with endovascular thrombectomy, how should tenecteplase be used? -Treat with IV tenecteplase (standard- or low-dose) or not at all.
3. In any patient receiving IVT, what is the optimal dose of tenecteplase? - use standard-dose (0.25 mg/kg body weight) or low-dose tenecteplase (0.18 mg/kg).
4. To what extent is the treatment effect of standard- vs. low-dose tenecteplase modified by key patient characteristics, such as diabetes, prior antiplatelet therapy, renal failure, or frailty, old age or having a heavy burden of cerebral small vessel disease on brain imaging. conditions: Acute Ischemic Stroke AIS conditions: Stroke Acute conditions: Stroke, Acute, Stroke Ischemic studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomization will be stratified by: (1) planned emergency endovascular thrombectomy (EVT) and (2) known use or history to suggest use of a standard-dose direct oral anticoagulant (DOAC) within the last 24 hours. Randomization will be centralized, secure and concealed, using a web-based server and permuted blocks of varying sizes will be used.

This will result in four pre-defined strata: (i) EVT+ / DOAC+ (ii) EVT+ / DOAC- (iii) EVT- / DOAC+ and (iv) EVT- / DOAC-.

Patients in strata 1, 2 and 3 will be randomized to standard-dose IV tenecteplase (0.25 mg/kg body weight) vs. Low-dose tenecteplase (0.18 mg/kg body weight) or no IV thrombolysis (1:1:1 randomization). Patients in strata 4 will be randomized to standard-dose intravenous (IV) tenecteplase (0.25 mg/kg body weight) vs. Low-dose IV tenecteplase (0.18 mg/kg body weight) only (1:1 randomization).

Emergency EVT is defined as anticipated arterial puncture time in the enrolling hospital ≤ 60 minutes from randomization. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The trial will have allocation concealment and blinded endpoint assessment, but open-label treatment. Given the time sensitive nature of acute stroke treatment, blinding the enrolling personnel to treatment assignment is not practical. Clinical site staff, including the Principal Investigator (PI), sub-investigators, clinic site staff, and the Sponsor will not be blinded to treatment allocated or received. In the event of an emergency the PI will be already unblinded.

The trial will have blinded endpoint assessment on Day 90, with central blinded assessors contacting the participants. whoMasked: OUTCOMES_ASSESSOR count: 4000 type: ESTIMATED name: Tenecteplase measure: A reduction of functional dependence analyzed across the whole distribution of outcomes assessed on the modified Rankin Scale (mRS), measure: 90-day mortality measure: Proportion of participants with a Modified Rankin Scale (mRS) of 0-1 at Day 90. measure: Proportion of participants with a Modified Rankin Scale (mRS) of 0-2 at Day 90. measure: Health-related quality of life, as measured by the EQ-5D-5L at Day 90. measure: The frequencies of Serious Adverse Events (SAEs) from enrollment up to Day 4 measure: Symptomatic intracranial hemorrhage measure: Large parenchymal hemorrhage (PH-2) measure: Ordinal shift of 7 levels of mRS at 90 days measure: Proportion of participants achieving first pass (eTICI 2c or higher) reperfusion (when treated with EVT). measure: Proportion of participants achieving successful recanalization (revised arterial occlusive lesion [rAOL] score of 2b-3) at first angiographic acquisition (when treated with EVT). measure: Ambulatory status at discharge measure: Place of residence at 90 days measure: Imaging assessment (e.g., infarct size and edema volume) measure: Summative total length of hospital stay in the first 90-days after stroke onset sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The George Institute for Global Health city: Sydney state: Barangaroo zip: NSW 2000 country: Australia name: Xiaoying Chen, PHD role: CONTACT email: xchen@georgeinstitute.org.au name: Craig Anderson, MD role: PRINCIPAL_INVESTIGATOR lat: -33.86785 lon: 151.20732 facility: University of Calgary city: Calgary state: Alberta zip: T2N 1N4 country: Canada name: Carol C Kenney, RN role: CONTACT phone: 4039444286 email: ckenney@ucalgary.ca name: Michael D Hill, MD role: CONTACT email: michael.hill@ucalgary.ca name: Michael D Hill, MD role: PRINCIPAL_INVESTIGATOR lat: 51.05011 lon: -114.08529 hasResults: False

 nctId: NCT06320418 id: RHDIRB2020110301REC#196 briefTitle: The Epigenetic Regulatory Role of P-element Induced Wimpy Testis (Piwi) Interacting RNA-823 (piR-823) in Ovarian Cancer Progression overallStatus: ACTIVE_NOT_RECRUITING date: 2022-06-15 date: 2023-12-10 date: 2024-06 date: 2024-03-20 date: 2024-03-20 name: Ain Shams University class: OTHER briefSummary: Ovarian cancer (OC) has one of the highest mortality rates for female malignant tumors, attributed to advanced cancer stages upon diagnosis as well as a high recurrence rate. Piwi-interacting RNA-823 (piR-823) is a single-stranded non-protein coding RNA (ncRNA) star molecule in epigenetics research. Extensive cellular regulatory functions and aberrant expression of piR-823 have been implicated in carcinogenesis. Therefore, the findings of piwi-ncRNA dysregulated-expression in OC Egyptian female patients' cohort could be employed as a potential novel mechanism for OC precision, a step toward ncRNA-precision conditions: Ovarian Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 56 type: ACTUAL measure: Association of piR-823 expression with ovarian cancer progression sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Pharmacy, Ain Shams University, Advanced Biochemistry Research Lab city: Cairo zip: 11566 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06320405 id: STUDY00025940 id: NCI-2024-01397 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: STUDY00025940 type: OTHER domain: OHSU Knight Cancer Institute briefTitle: Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-04-01 date: 2029-04-01 date: 2024-03-20 date: 2024-03-20 name: OHSU Knight Cancer Institute class: OTHER name: Oregon Health and Science University name: Incyte Corporation briefSummary: This phase I/II trial tests the safety, side effects, and effectiveness of axatilimab in combination with retifanlimab and paclitaxel for the treatment of patients with a solid tumor that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Axatilimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Giving axatilimab in combination with retifanlimab and paclitaxel may be safe, tolerable and/or effective in treating patients with advanced or metastatic solid tumors. conditions: Advanced Malignant Solid Neoplasm conditions: Metastatic Malignant Solid Neoplasm conditions: Recurrent Malignant Solid Neoplasm conditions: Refractory Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 38 type: ESTIMATED name: Axatilimab name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Magnetic Resonance Imaging name: Paclitaxel name: Positron Emission Tomography name: Retifanlimab measure: Incidence of dose limiting toxicities (phase Ib) measure: Recommended phase 2 dose of the study drug combination (phase Ib) measure: Clinical benefit rate (phase Ib/II) measure: Incidence of ≥ grade 3 toxicities possibly or definitely related to study drugs measure: Changes in immune cell composition and functionality measure: Change in immune cell population sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OHSU Knight Cancer Institute city: Portland state: Oregon zip: 97239 country: United States name: Shivaani Kummar role: CONTACT phone: 503-494-6594 email: kummar@ohsu.edu name: Shivaani Kummar role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 hasResults: False

 nctId: NCT06320392 id: RHDIRB2020110301 REC#48 briefTitle: Implication of CCR4-NOT Complex Subunit 7 Expression in Natural Killer Cell Resistance in Metastatic Breast Cancer acronym: CCR4-NOT overallStatus: ACTIVE_NOT_RECRUITING date: 2021-07-01 date: 2023-05-01 date: 2024-06-01 date: 2024-03-20 date: 2024-03-20 name: Ain Shams University class: OTHER briefSummary: Being a mechanistic study, this work aims to figure out "the role of the cytoplasmic mRNA deadenylase CNOT7 expressed protein on NK cell resistance in metastatic BC". In other words, to explore, whether, "CNOT7 contributes to metastasis in Egyptian female metastatic BC patient's cohort, through NK cell resistance, or not." conditions: Metastatic Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 90 type: ACTUAL measure: Cytoplasmic mRNA deadenylase CNOT7 protein expression level in metastatic/advanced localized and non-metastatic BC sera using ELISA. measure: CNOT7 tissue expression level in BC tissue samples categorized as metastatic vs non-metastatic tumor alongside with adjacent non-tumor tissue margin using immunohistochemistry. measure: LAIR-1 protein expression level in BC patients peripheral blood samples using ELISA. sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Pharmacy, Ain Shams University, Advanced Biochemistry Research Lab city: Cairo zip: 11566 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06320379 id: RB071522 briefTitle: Zypan Functional Dyspepsia overallStatus: RECRUITING date: 2023-03-15 date: 2024-06-01 date: 2024-12-31 date: 2024-03-20 date: 2024-03-20 name: National University of Natural Medicine class: OTHER briefSummary: The purpose of this study is to determine the effects of a readily available dietary supplement on quality of life and digestion in adults with functional dyspepsia. conditions: Dyspepsia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to take either a placebo or Zypan dietary supplement three times per day for four weeks. primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: Zypan name: Placebo Comparator measure: Protein Assimilation measure: Protein Assimilation measure: Mineral concentrations in blood measure: Mineral concentrations in blood measure: Fat-soluble vitamin concentration in blood measure: Fat-soluble vitamins measure: Leeds Dyspepsia Questionnaire measure: Leeds Dyspepsia Questionnaire measure: Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale measure: Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale measure: Microbiota Relative Abundance and Composition measure: Microbiota Relative Abundance and Composition measure: Blood glucose measure: Blood glucose measure: Urea Nitrogen measure: Urea Nitrogen measure: Creatinine measure: Creatinine measure: Urea Nitrogen to creatinine ratio measure: Urea Nitrogen to creatinine ratio measure: Sodium measure: Sodium measure: Potassium measure: Potassium measure: Chloride measure: Chloride measure: Carbon Dioxide measure: Carbon Dioxide measure: Calcium measure: Calcium measure: Total Protein measure: Total Protein measure: Albumin measure: Albumin measure: Globulin measure: Globulin measure: Albumin to Globulin ratio measure: Albumin to Globulin ratio measure: Bilirubin measure: Bilirubin measure: Alkaline Phosphatase measure: Alkaline Phosphatase measure: aspartate aminotransferase measure: aspartate aminotransferase measure: Alanine aminotransferase measure: Alanine aminotransferase measure: Estimated glomerular filtration rate measure: Estimated glomerular filtration rate measure: White blood cell count measure: White blood cell count measure: Red blood cell count measure: Red blood cell count measure: Hemoglobin measure: Hemoglobin measure: Hematocrit measure: Hematocrit measure: Mean corpuscular volume measure: Mean corpuscular volume measure: Mean corpuscular hemoglobin measure: Mean corpuscular hemoglobin measure: Mean corpuscular hemoglobin concentration measure: Mean corpuscular hemoglobin concentration measure: Erythrocyte distribution width measure: Erythrocyte distribution width measure: Platelet count measure: Platelet count measure: Neutrophils measure: Neutrophils measure: Band Neutrophils measure: Band Neutrophils measure: Absolute band neutrophils measure: Absolute band neutrophils measure: Metamyelocytes measure: Metamyelocytes measure: Absolute Metamyelocytes measure: Absolute Metamyelocytes measure: Myelocytes measure: Myelocytes measure: Absolute Myelocytes measure: Absolute Myelocytes measure: Promyelocytes measure: Promyelocytes measure: Absolute Promyelocytes measure: Absolute Promyelocytes measure: Absolute Neutrophils measure: Absolute Neutrophils measure: Lymphocytes measure: Lymphocytes measure: Reactive Lymphocytes measure: Reactive Lymphocytes measure: Absolute Lymphocytes measure: Absolute Lymphocytes measure: Monocytes measure: Monocytes measure: Absolute monocytes measure: Absolute monocytes measure: Eosinophils measure: Eosinophils measure: Absolute Eosinophils measure: Absolute Eosinophils measure: Basophils measure: Basophils measure: Absolute Basophils measure: Absolute Basophils measure: Blasts measure: Blasts measure: Absolute Blasts measure: Absolute Blasts measure: Nucleated red blood cells measure: Absolute Nucleated red blood cells measure: Absolute Nucleated red blood cells measure: Platelet mean volume measure: Platelet mean volume sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Helfgott Research Institute status: RECRUITING city: Portland state: Oregon zip: 97201 country: United States name: Anders Gundersen, MS role: CONTACT lat: 45.52345 lon: -122.67621 hasResults: False

 nctId: NCT06320366 id: 23-1044 id: K24DA058882 type: NIH link: https://reporter.nih.gov/quickSearch/K24DA058882 briefTitle: Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-05-31 date: 2028-05-31 date: 2024-03-20 date: 2024-03-21 name: University of Colorado, Denver class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: The investigators will evaluate the effects of an accelerated Transcranial Magnetic Stimulation (TMS) protocol of the left dorsolateral prefrontal cortex (DLPFC) for moderate to severe methamphetamine use disorder. This is a randomized parallel group design to assess feasibility and safety, evaluate efficacy (use, craving) and identify magnetic resonance imaging (resting state and cue craving) associated with group/outcomes. conditions: Methamphetamine Use Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Sham vs. real Transcranial Magnetic Stimulation (TMS) primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participant and all study personnel are blinded. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Sham TMS name: Active TMS measure: Tolerability measure: Study emergent adverse events measure: Weeks of continuous abstinence measure: Days of methamphetamine use measure: Methamphetamine craving measure: Methamphetamine craving on visual analog scale measure: MRI cue craving measure: MRI resting state sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Anschutz Medical Campus city: Aurora state: Colorado zip: 80045 country: United States name: Joseph T Sakai, MD role: CONTACT phone: 303-724-7402 email: joseph.sakai@cuanschutz.edu name: Kristen M Raymond, BA role: CONTACT phone: 303-724-3196 email: kristen.raymond@cuanschutz.edu name: Joseph T Sakai, MD role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 hasResults: False

 nctId: NCT06320353 id: CL01860211 briefTitle: Study сomparing the Efficacy and Safety of RPH-075 and Keytruda® in Patients With Unresectable or Metastatic Skin Melanoma overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-27 date: 2024-06 date: 2026-01 date: 2024-03-20 date: 2024-03-20 name: R-Pharm class: INDUSTRY name: Data Management 365 name: Exacte Labs LLC name: Federal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor briefSummary: The goal of this double-blind, randomized study is to establish the equivalence of the efficacy, safety and immunogenicity of the drugs RPH-075 (international nonproprietary name (INN) is pembrolizumab) and Keytruda® (INN is pembrolizumab) when used in patients with unresectable or metastatic skin melanoma first or second line therapy in a monotherapy regimen.

The main task is to evaluate and compare the effectiveness of RPH-075 and Keytruda® drugs when used in patients with unresectable or metastatic skin melanoma as a 1 or 2 line therapy in monotherapy regimen, according to the objective response rate (ORR) parameter for up to 24 weeks of therapy. conditions: Skin Melanoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 266 type: ACTUAL name: RPH-075 name: Keytruda® measure: The objective response rate (ORR) measure: The disease control rate (DCR) measure: The time to response (TTR) measure: The Duration of response (DOR) measure: The Progression-free survival (PFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Federal State Budgetary Institution "National Medical Research Center of Radiology" of the Ministry of Health of the Russian Federation city: Obninsk state: Kaluga Region zip: 249036 country: Russian Federation lat: 55.09681 lon: 36.61006 facility: State Budgetary Healthcare Institution "Clinical Oncological Dispensary No. 1" of the Ministry of Health of the Krasnodar Territory city: Krasnodar state: Krasnodar Territory zip: 350040 country: Russian Federation lat: 45.04484 lon: 38.97603 facility: Regional Budgetary Healthcare Institution "Kursk Oncological Research and Clinical Center named after G.E. Ostroverkhov" city: Kislino state: Kursk Region zip: 305524 country: Russian Federation facility: State Budgetary Healthcare Institution of the city of Moscow "Moscow City Oncological Hospital No. 62 of the Department of Health of the City of Moscow" city: Istra state: Moscow Region zip: 143515 country: Russian Federation lat: 55.91997 lon: 36.86867 facility: The State budgetary healthcare Institution of the Stavropol Territory "Pyatigorsk Interdistrict Oncological Dispensary" city: Pyatigorsk state: Stavropol Territory zip: 357502 country: Russian Federation lat: 44.04861 lon: 43.05944 facility: The State Autonomous Healthcare Institution of the Sverdlovsk region "Sverdlovsk Regional Oncological Dispensary" city: Ekaterinburg state: Sverdlovsk Region zip: 620036 country: Russian Federation lat: 56.8519 lon: 60.6122 facility: State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the Ministry of Health of the Republic of Bashkortostan city: Ufa state: The Republic Of Bashkortostan zip: 450054 country: Russian Federation lat: 54.74306 lon: 55.96779 facility: State Autonomous Healthcare Institution "Republican Clinical Oncological Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z.Segal" city: Kazan state: The Republic Of Tatarstan zip: 420029 country: Russian Federation lat: 55.78874 lon: 49.12214 facility: Budgetary Healthcare Institution of the Udmurt Republic "Sergey Grigoryevich Primushko Republican Clinical Oncological Dispensary of the Ministry of Health of the Udmurt Republic" city: Izhevsk state: Udmurt Republic zip: 426009 country: Russian Federation lat: 56.84976 lon: 53.20448 facility: State Budgetary Healthcare Institution of the Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary" city: Arkhangelsk zip: 163045 country: Russian Federation lat: 64.5401 lon: 40.5433 facility: State Budgetary Healthcare Institution "Regional Oncological Dispensary" city: Irkutsk zip: 664035 country: Russian Federation lat: 52.29778 lon: 104.29639 facility: Regional budgetary healthcare institution "Ivanovo Regional Oncological Dispensary" city: Ivanovo zip: 153040 country: Russian Federation lat: 56.99719 lon: 40.97139 facility: Kaluga Region State Budgetary Healthcare Institution "Kaluga Regional Clinical Oncological Dispensary" city: Kaluga zip: 248007 country: Russian Federation lat: 54.5293 lon: 36.27542 facility: State Budgetary healthcare Institution "Kuzbass Clinical Oncological Dispensary named after M.S. Rappoport" city: Kemerovo zip: 650036 country: Russian Federation lat: 55.33333 lon: 86.08333 facility: Regional State Budgetary Healthcare Institution "Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky" city: Krasnoyarsk zip: 660133 country: Russian Federation lat: 56.01839 lon: 92.86717 facility: State Budgetary Institution of healthcare of the city of Moscow "Moscow Multidisciplinary Clinical Center "Kommunarka" of the Department of Healthcare of the City of Moscow" city: Moscow zip: 108814 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation city: Moscow zip: 115478 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: State Budgetary Healthcare Institution of the city of Moscow "City Clinical Oncological Hospital No. 1 of the Department of Health of the City of Moscow" city: Moscow zip: 117152 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Federal State Autonomous Education Insitution of High Education the First Moscow State Medical University named after I.M. Sechenov of Ministry of Healthcare of Russian Federation (Sechenov University) city: Moscow zip: 119991 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Branch Office of "Hadassah Medical Ltd" city: Moscow zip: 121205 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: "Moscow Center for Rehabilitation Treatment" LLC city: Moscow zip: 121552 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Medsi Group of Companies JSC city: Moscow zip: 123056 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: "Research lab" LLC city: Moscow zip: 127521 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: State Budgetary Healthcare Institution of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Oncological Dispensary" city: Nizhny Novgorod zip: 603126 country: Russian Federation lat: 56.32867 lon: 44.00205 facility: State Budgetary Healthcare Institution of the Novosibirsk region "Novosibirsk Regional Clinical Oncological Dispensary" city: Novosibirsk zip: 630108 country: Russian Federation lat: 55.0415 lon: 82.9346 facility: Budgetary healthcare institution of the Omsk region "Clinical Oncological Dispensary" city: Omsk zip: 644013 country: Russian Federation lat: 54.99244 lon: 73.36859 facility: State Budgetary Healthcare Institution of the Perm Territory "Perm Regional Oncological Dispensary" city: Perm zip: 614066 country: Russian Federation lat: 58.01046 lon: 56.25017 facility: State Budgetary Healthcare Institution Leningrad Regional Clinical Hospital city: Saint Petersburg zip: 188300 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Private healthcare institution "Clinical Hospital "Russian Railways-Medicine" of the city of St. Petersburg" city: Saint Petersburg zip: 195271 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: "Euro Cityclinic" LLC city: Saint Petersburg zip: 197022 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: St. Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary" city: Saint Petersburg zip: 197022 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: State Budgetary Healthcare Institution "Samara Regional Clinical Oncological Dispensary" city: Samara zip: 443031 country: Russian Federation lat: 53.20007 lon: 50.15 facility: State Healthcare Institution "Regional Clinical Oncological Dispensary" city: Saratov zip: 410053 country: Russian Federation lat: 51.54056 lon: 46.00861 facility: Regional State Budgetary Healthcare Institution "Smolensk Regional Oncological Clinical Dispensary" city: Smolensk zip: 214000 country: Russian Federation lat: 54.7818 lon: 32.0401 facility: Siberian State Medical University of the Ministry of Healthcare of Russian Federation city: Tomsk zip: 634050 country: Russian Federation lat: 56.49771 lon: 84.97437 facility: The State Autonomous healthcare Institution of the Tyumen region "Multidisciplinary clinical Medical Center "Medical City" city: Tyumen zip: 625041 country: Russian Federation lat: 57.15222 lon: 65.52722 hasResults: False

 nctId: NCT06320340 id: 07032024 briefTitle: Effectiveness of NMES on Neck Pain overallStatus: COMPLETED date: 2021-03-15 date: 2021-05-15 date: 2021-09-15 date: 2024-03-20 date: 2024-03-20 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: The aim of this randomized-controlled study was to determine the effectiveness of neuromuscular electrical stimulation (NMES) applied simultaneously to exercise on pain, static endurance of cervical deep flexor muscles, fear of movement and disability in chronic neck pain. The participants were randomly assigned to one group which in only five clinical pilates exercises were performed (Group I) or the other group which NMES was applied on lower trapezius and serratus anterior muscles while the same exercises were performing (Group II). conditions: Chronic Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 36 type: ACTUAL name: Exercise name: Electrotherapy measure: Neck disability measure: Neck disability measure: Pain intensity measure: Pain intensity measure: Range of Motion measure: Range of Motion measure: Static endurance of cervical deep flexor muscles measure: Static endurance of cervical deep flexor muscles measure: Fear of the movement measure: Fear of the movement sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: İstanbul Aydın University city: İstanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06320327 id: 80177 briefTitle: Topical CBD's Effects on Soreness and Performance overallStatus: COMPLETED date: 2022-08-23 date: 2023-04-27 date: 2023-04-30 date: 2024-03-20 date: 2024-03-20 name: Joseph Pastina class: OTHER briefSummary: Exercise-induced muscle damage (EIMD) results from unaccustomed exercise and can lead to delayed onset muscle soreness (DOMS). Impairments associated with EIMD and DOMS can result in moderate-to-severe discomfort and hindered performance. Recently, a compound derived from the cannabis plant, cannabidiol (CBD), has been used as a recovery tool for EIMD and DOMS. Despite the rising popularity of CBD products, their effectiveness in mitigating EIMD and DOMS is unknown. Specifically, to the investigators' knowledge, no clinical trials have been completed to assess the effects of topical CBD cream application on soreness, recovery and performance.

Therefore, the purpose of the present study was to investigate the effects of CBD cream on DOMS and performance after an intensive lower-body exercise protocol. Specifically, the study's aims were:

Aim 1: To assess the effect of topical CBD cream administration on muscle soreness following fatiguing exercise.

Hypothesis 1: CBD cream would decrease perceived muscle soreness when compared to a placebo or control (no cream) group.

Aim 2: To assess the effect of topical CBD cream administration on muscular performance following fatiguing exercise.

Hypothesis 2: Recovery of muscular power would be quicker when CBD cream is applied, compared to a placebo or control (no cream) group.

Aim 3: To assess if topical CBD cream has a localized (if any) or systemic effect on muscle soreness.

Hypothesis 3: Improvements in muscle soreness would only be observed in localized muscles around where the CBD cream was applied. conditions: Muscle Soreness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The research participant's and research personnel conducting the testing will be blinded to who is in the CBD and placebo groups throughout the study. Those in Group 3 (the control group) will be aware that they are in the control group, as they will be skipping the steps involving cream application. The protocols for Group 1 and Group 2 will be identical and the respective cream will be made available to the testers and participants in identical containers. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Cannabidiol cream name: Placebo cream measure: Vertical Jump Test measure: Peak Isokinetic Torque Test measure: Pressure-Pain Threshold Test sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Seaton Center Building city: Lexington state: Kentucky zip: 40502 country: United States lat: 37.98869 lon: -84.47772 facility: Multidisciplinary Science Building city: Lexington state: Kentucky zip: 40536 country: United States lat: 37.98869 lon: -84.47772 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-08-04 uploadDate: 2024-03-13T17:59 filename: ICF_000.pdf size: 187622 hasResults: False

 nctId: NCT06320314 id: LRP23021-E serum briefTitle: Efficacy and Tolerability of Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins overallStatus: RECRUITING date: 2024-02-19 date: 2024-05-22 date: 2024-05-22 date: 2024-03-20 date: 2024-03-20 name: Cosmetique Active International class: INDUSTRY briefSummary: The objective of this study is to evaluate the efficacy, cosmetic acceptability and improvement of the stigmatization of the tested product (2039125 03) used bis in die (BID) for 3 months in adult patients suffering from mild to moderate melasma, or mild to moderate acne induced post-inflammatory hyperpigmentation, or solar lentigo. conditions: Hyperpigmentation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 60 type: ESTIMATED name: tested product (2039125 03) measure: IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP) measure: modified Melasma Area and Severity Index (mMASI) for patients with melasma measure: Post-Acne Hyperpigmentation Index (PAHPI) measure: colorimetry measurements sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PhDTrials Center status: RECRUITING city: Lisboa country: Portugal name: Pedro Pinto role: CONTACT phone: +351 216034267 phoneExt: 501 email: geral@phdtrials.com lat: 38.71667 lon: -9.13333 hasResults: False

 nctId: NCT06320301 id: SYSKY-2024-027-01 briefTitle: Adebrelimab and a TKI in Combination With GEMOX in First-line Treatment of Advanced Biliary Tract Cancers (BTC) overallStatus: RECRUITING date: 2024-04-01 date: 2026-02-01 date: 2026-06-01 date: 2024-03-20 date: 2024-03-20 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER name: Suzhou Suncadia Biopharmaceuticals Co., Ltd. briefSummary: Patients with advanced biliary tract malignant tumors who had not received systematic treatment before and could not be cured were selected as the subjects of the study. The primary endpoint of the study was investigator-assessed 6-month progression-free survival (6-month PFS%) based on the RECIST v1.1 criteria, and 43 subjects were planned to be enrolled. Patients eligible for enrollment will receive Adebrelimab and a tyrosine kinase inhibitor (TKI) in combination with gemcitabine and oxaliplatin (GEMOX). conditions: Biliary Tract Cancer conditions: Gemox Chemotherapy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 43 type: ESTIMATED name: Adebrelimab + GEMOX + TKI measure: the effectiveness of first-line treatment with Adebrelimab and a tyrosine kinase inhibitor (TKI) in combination with gemcitabine and oxaliplatin (GEMOX) in patients with advanced BTC measure: To assess the progression-free survival (PFS) measure: To evaluate the time to progression (TTP) measure: To evaluate the disease control rate (DCR), measure: To evaluate the objective response rate (ORR) measure: To evaluate the duration of response (DoR) measure: To evaluate the overall survival (OS). measure: To explore the correlation between biomarkers and the efficacy of the combination regimen. measure: The PFS based on an immunomodified RECIST (imRECIST） measure: The TTP based on an immunomodified RECIST (imRECIST） measure: The ORR based on an immunomodified RECIST (imRECIST） measure: The DCR based on an immunomodified RECIST (imRECIST） measure: The DoR based on an immunomodified RECIST (imRECIST） sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University status: RECRUITING city: Guanzhou state: Guangdong zip: 512000 country: China name: Junkai Ren role: CONTACT phone: 86-18664506517 email: rjk119234@163.com name: Wenbin Li role: CONTACT phone: 86-13602773101 hasResults: False

 nctId: NCT06320288 id: IRR-FLAVIGNY-2023-1 briefTitle: Analysis of Trunk and Center of Mass Control Development During Gait in Children With Cerebral Palsy (VERTEBRAL) acronym: VERTEBRAL overallStatus: RECRUITING date: 2023-09-20 date: 2025-09 date: 2028-09 date: 2024-03-20 date: 2024-03-20 name: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est class: OTHER briefSummary: During the acquisition of posturokinetic abilities such as walking, postural control of the trunk is of paramount importance. Indeed, its development is strongly linked to the overall motor function of children. In cerebral palsy (CP), a term that refers to a set of motor disorders following a perinatal lesion, deficits in axial control are present from early childhood. These deficits are strongly correlated with the functional deficits observed in this population. In particular, during walking, deviations of the trunk (amplitudes, accelerations) are observed in the three planes of space. While recent literature increasingly questions the impact of trunk control deficit on the walking of children with CP, elements are still missing for a holistic understanding of the interaction between locomotor and postural disorders in children with CP. In particular, no study has focused on the deviations of trunk control and the center of mass (which is a global indicator of balance strategies) during the development and maturation of walking in children with CP. Therefore, the primary objective of this cross-sectional observational study will be to characterize the development of trunk control and center of mass during walking in children with CP. conditions: Children With Cerebral Palsy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 270 type: ESTIMATED measure: Trunk and center-of-mass accelerations and acceleration variability measure: Gait Variability Index measure: Trunk Control Measurement Scale score (TCMS) measure: Early Clinical Assessment of Balance score sex: ALL minimumAge: 18 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Institut Régional de Médecine Physique et de Réadaptation status: RECRUITING city: Nancy zip: 54000 country: France name: Jonathan Pierret, PhD role: CONTACT phone: +33 3 82 52 6761 email: jonathan.pierret@ugecam.assurance-maladie.fr lat: 48.68439 lon: 6.18496 hasResults: False

 nctId: NCT06320275 id: self-efficiency briefTitle: Fathers' Breastfeeding Self-efficiency overallStatus: COMPLETED date: 2023-02-01 date: 2023-05-30 date: 2023-07-30 date: 2024-03-20 date: 2024-03-20 name: Cukurova University class: OTHER briefSummary: The purpose of this study was planned to examine the effect of the education given through digital storytelling method on fathers' breastfeeding self-efficacy perception. The research is in a quasi-experimental design with no pretest-posttest control group. conditions: FATHER conditions: BREASTFEEDING studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: INVESTIGATOR count: 80 type: ACTUAL name: Storytelling Intervention measure: Breastfeeding Self-Efficacy Scale for Fathers Short Form sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cukurova University city: Adana state: Balcalı zip: 01 330 country: Turkey lat: 37.00167 lon: 35.32889 facility: Çukurova city: Adana state: Balcalı zip: 01330 country: Turkey lat: 37.00167 lon: 35.32889 facility: Çukurova University city: Adana zip: 01330 country: Turkey lat: 37.00167 lon: 35.32889 hasResults: False

 nctId: NCT06320262 id: NRC/TDF/01/F briefTitle: Evaluation of the Effect of Wet Cupping (Hijama) on Primary Fibromyalgia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2025-04 date: 2024-03-20 date: 2024-03-22 name: Rasmia Elgohary class: OTHER briefSummary: Fibromyalgia has become one of the most prevalent chronic pain conditions that impair quality of life. Wet cupping has gained increasing popularity in treating painful conditions.

This study aims to investigate the effectiveness of wet cupping therapy combined with home-based exercise compared to home-based exercise alone in improving patients diagnosed with primary fibromyalgia syndrome. conditions: Treatment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled drugs primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Wet cupping therapy (WCT) measure: Change from baseline brain MRS measure: Change from baseline Visual Analog Scale (VAS) measure: Change from baseline in the individual components of the Fibromyalgia Impact Questionnaire Revised (FIQR) measure: Change from the baseline sleep disturbance using the Jenkins sleep score (JSS) measure: Change from baseline Fatigue- VAS. measure: Change from baseline of Hospital Anxiety and Depression Scale (HADS) measure: Change from baseline of the Montreal Cognitive Assessment (MoCA) measure: Change from baseline of the Widespread pain index (WPI) measure: Change from baseline hemoglobin measure: patient compliance on exercise as instructed sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06320249 id: WJYY-XZKT-2023-05 briefTitle: Rotation-traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-30 date: 2025-06-30 date: 2024-03-20 date: 2024-03-20 name: Wangjing Hospital, China Academy of Chinese Medical Sciences class: OTHER name: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine name: Affiliated Hospital of Changchun University of Chinese Medicine name: Dongzhimen Hospital, Beijing University of Chinese Medicine briefSummary: The evidence for different frequencies of rotation-traction manipulation treatment in cervical radiculopathy is insufficient. This study determined whether 3 sessions per week of rotation-traction manipulation treatment are superior to 1 session per week for symptomatic outcomes in cervical radiculopathy based on a multicenter randomized controlled trial. conditions: Cervical Radiculopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This study did not implement blinding for the manipulative therapists and participants. However, blinding procedures were employed for the outcome assessors and data analysts, meaning that they remained unaware of the group. whoMasked: OUTCOMES_ASSESSOR count: 216 type: ESTIMATED name: High-frequency rotation-traction manipulation name: Low-frequency rotation-traction manipulation name: Cervical traction measure: The Visual Analog Scale for Pain measure: The Visual Analog Scale for Pain measure: The Visual Analog Scale for Pain measure: The Visual Analog Scale for Pain measure: The Visual Analog Scale for Pain measure: The Visual Analog Scale for Pain measure: The Visual Analog Scale for Numbness measure: The Visual Analog Scale for Numbness measure: The Visual Analog Scale for Numbness measure: The Visual Analog Scale for Numbness measure: The Visual Analog Scale for Numbness measure: The Visual Analog Scale for Numbness measure: The Neck Disability Index measure: The Neck Disability Index measure: The Neck Disability Index measure: The Neck Disability Index measure: The Neck Disability Index measure: The Neck Disability Index measure: The Short Form 12 measure: The Short Form 12 measure: The Short Form 12 measure: The Short Form 12 measure: The Short Form 12 measure: The Short Form 12 measure: The total cost measure: The recurrence rate measure: Expectation of Treatment and Credibility Scale measure: Expectation of Treatment and Credibility Scale measure: Adverse reactions sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wangjing Hospital, China Academy of Chinese Medical Sciences city: Beijing state: Beijing zip: 100102 country: China name: Xu Wei, Ph.D role: CONTACT phone: 13488716557 email: weixu.007@163.com name: Tianxiao Feng, Ph.D role: CONTACT phone: 15733196045 email: fengtianxiao96@163.com name: Xu Wei, Ph.D role: PRINCIPAL_INVESTIGATOR name: Aifeng Liu, Ph.D role: SUB_INVESTIGATOR name: Yanguo Wang, Ph.D role: SUB_INVESTIGATOR name: Zhenhua Li, Ph.D role: SUB_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06320236 id: 4603 briefTitle: Emergency Medicine Pulmonary Embolism Testing Multicentre Study acronym: EMPET overallStatus: RECRUITING date: 2024-01-01 date: 2026-09-30 date: 2027-09-30 date: 2024-03-20 date: 2024-03-20 name: Dr. Kerstin de Wit class: OTHER name: Canadian Institutes of Health Research (CIHR) briefSummary: It is important to diagnose pulmonary embolism in a timely manner to prevent death and long-term disability. More than half a million people (4-5% of emergency department patients) are tested for pulmonary embolism, although positive results are low. Imaging for PE testing exposes patients to radiation, is expensive, adds time to the emergency visit, and can lead to a false positive diagnoses. Existing protocols aimed at reducing unnecessary pulmonary embolism imaging are complex and seldom used by emergency physicians. Too many patients undergo unnecessary pulmonary embolism imaging.

We have created a new tool (called Adjust-Unlikely) which could safely reduce pulmonary embolism imaging in Canada. Our research group composed of researchers, emergency physicians, and patients developed the Adjust-Unlikely clinical decision rule: a rule which has been customized for emergency physicians and emergency patients. Adjust-Unlikely is highly sensitive at the bedside, meaning there are very few false negative results.

Our study aim is to prospectively validate Adjust-Unlikely pulmonary embolism testing in emergency patients with suspected pulmonary embolism. conditions: Pulmonary Embolism conditions: D-dimer conditions: Diagnosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 4000 type: ESTIMATED name: Adjust-Unlikely measure: Venous thrombosis measure: Venous thrombosis measure: Index presentation Adjust-Unlikely testing results sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kingston Health Sciences Centre status: RECRUITING city: Kingston state: Ontario zip: K7L 2V7 country: Canada name: Natasha Clayton, CRA, RA role: CONTACT phone: 4165663590 email: natasha.clayton@queensu.ca name: Kerstin de Wit, MD role: PRINCIPAL_INVESTIGATOR lat: 44.22976 lon: -76.48101 hasResults: False

 nctId: NCT06320223 id: PROMISE PET Registry briefTitle: PROMISE PET Registry on PSMA-PET and Outcome in Prostate Cancer acronym: PROMISE-PET overallStatus: RECRUITING date: 2024-03-05 date: 2034-03-05 date: 2035-03-05 date: 2024-03-20 date: 2024-03-20 name: University Hospital, Essen class: OTHER briefSummary: Background:

PROMISE criteria have been defined for standardized reporting of Prostate-Specific Membrane Antigen (PSMA) PET whole-body stage of prostate cancer. PSMA PET disease extent by PROMISE has been associated with oncologic outcome.

Need:

Improved prognostication across various stages of prostate cancer is needed for management guidance and study design.

Aim:

1. To assess the prognostic value of PSMA PET
2. To compare the prognostic value of PSMA PET with clinical prognostic scores in patients with prostate cancer at various disease stages

Inclusion:

* Adult patients with
* biopsy/histo proven prostate cancer who
* underwent PSMA PET (any type)
* for staging or re-staging at any stage and who
* have at least 3-year overall survival follow-up data available will be included consecutively.

Exclusion:

* Patients with neuroendocrine prostate cancer
* Patients with metastasized or disseminated malignancy other than prostate cancer conditions: Prostate Cancer conditions: PET/CT conditions: Survivorship conditions: PSMA studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10000 type: ESTIMATED measure: Overall survival measure: Metastasis-free survival sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Essen status: RECRUITING city: Essen zip: 45147 country: Germany name: Wolfgang P Fendler, M.D. role: CONTACT phone: +492017232032 email: redcap@ikim.nrw lat: 51.45657 lon: 7.01228 hasResults: False

 nctId: NCT06320210 id: IRB19-1308 briefTitle: Chicago Asthma School-Directed Child-Centered Assessment and Dissemination of Evidence acronym: CASCADE overallStatus: RECRUITING date: 2023-08-31 date: 2025-08-31 date: 2025-12-30 date: 2024-03-20 date: 2024-04-11 name: University of Chicago class: OTHER briefSummary: Research has shown that adherence to evidence-based asthma guidelines leads to improved outcomes, yet critical gaps remain in the implementation of these guidelines, particularly among minority and low-income youth. Schools represent a crucial point of intervention, as demonstrated by school-based asthma programs that have addressed individual components of the guidelines with promising results. This project aims to develop, implement, and evaluate a pragmatic, multi-component asthma program that builds upon existing targeted interventions to fully implement the asthma guidelines and integrate them in school practices to foster sustainability. The investigator seeks to understand whether this type of program will improve asthma outcomes at the child and school level. conditions: Asthma in Children studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 400 type: ESTIMATED name: Multicomponent program measure: Asthma control measure: Missed work days in parents measure: Asthma knowledge - parents measure: Asthma knowledge - child measure: Asthma quality of life - child measure: Caregiver quality of life measure: Asthma impact - parent measure: Missed school days measure: Healthcare utilization measure: Asthma impact - child sex: ALL minimumAge: 4 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Chicago Charter Schools status: RECRUITING city: Chicago state: Illinois zip: 60640 country: United States lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06320197 id: DROWN_INSITU briefTitle: In Situ Simulation Training in Lifeguard Organisations acronym: DROWN_INSITU overallStatus: RECRUITING date: 2018-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-20 date: 2024-03-20 name: Prehospital Center, Region Zealand class: OTHER briefSummary: This retrospective study will analyse a dataset consisting of 919 in situ simulation assessments collected between 2018 and 2023 in a Danish nationwide surf lifeguard organisation. The primary objective is to estimate the pass/fail ratio of in situ simulation assessments. The secondary objective is to analyse risk factors associated with a failed assessment. These results may guide future efforts to improve the Danish surf lifeguard training program. conditions: Drowning conditions: Drowning, Near conditions: Drowning and Nonfatal Submersion conditions: Drowning/Submersion conditions: Drowning and Submersion While in Natural Water studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: In situ simulation assessment measure: Pass/fail ratio of in situ simulation assessments measure: Risk factors associated with a failed assessment sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Prehospital Center status: RECRUITING city: Næstved state: Region Zealand zip: 4700 country: Denmark name: Niklas Breindahl, MD role: CONTACT phone: 004528566410 email: niklas.breindahl@regionh.dk name: Helle Collatz Christensen, MD, PhD role: CONTACT phone: 004521673452 email: helle.collatz.christensen.02@regionh.dk lat: 55.22992 lon: 11.76092 hasResults: False

 nctId: NCT06320184 id: INT 0083/23 briefTitle: AI for Lung Cancer Risk Definition in Computed Tomography Screening Programs overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-30 date: 2024-10-30 date: 2026-04-30 date: 2024-03-20 date: 2024-03-22 name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano class: OTHER name: University of Milano Bicocca briefSummary: Low-dose computed tomography (LDCT) lung cancer (LC) screening can reduce mortality among heavy smokers, but there is a critical need to better identify people at higher risk and to reduce harms related to management of benign nodules. The most promising strategy is to combine novel tools to optimize clinical decisions and increase the benefit of screening.

In this respect, the investigators already demonstrated that the combination of baseline LDCT features with a minimal invasive microRNA blood test was able to more precisely estimate the individual risk of developing LC. The investigators posit that additional immune-related and radiologic features can be integrated with the help of artificial intelligence (AI) to further implement LDCT screening strategies. The project will answer whether the combination of (bio)markers of different origin can predict LC development at baseline and over time, indicate which screen-detected lung nodules are likely to be malignant and ultimately reduce LC and all cause mortality. conditions: Lung Cancer conditions: Blood Biomarkers studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 650 type: ACTUAL name: Artificial Intelligence risk model measure: Aim 1 measure: Aim 2 measure: Aim 3 sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Istituto Nazionale dei Tumori city: Milan zip: 20133 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06320171 id: 240118,2024-481 briefTitle: Efectivity of Non-invasive Neuromodulation in Parasympathic Nervous System and Vascular System overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-04 date: 2024-06 date: 2024-03-20 date: 2024-03-20 name: Universidad Europea de Madrid class: OTHER briefSummary: The study, conducted by the Universidad Europea de Madrid, examines the immediate effects of a single session using NESA microcurrents on various circulatory system variables in healthy subjects. It divides participants into three groups based on session duration (15, 30, 45 minutes), measuring pre and post-intervention changes. The focus is on autonomic nervous system responses, aiming to understand the minimum treatment characteristics needed for significant autonomic changes. Variables studied include systolic and diastolic blood pressure, heart rate, and several ultrasound measurements of the common carotid artery (CSA), including thickness and peak systolic flow velocity. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Non-Invasive neuromodulation measure: Systolic and diastolic Blood Pressure: measure: Heart rate measure: Ultrasonographic variables: Cross-sectional area of the jugular vein measure: Ultrasonographic variables:Cross-sectional area of the common carotid measure: Ultrasonographic variables:Thickness of the common carotid measure: Ultrasonographic variables:Peak systolic velocity. measure: Cortisol measurement sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06320158 id: PNRR-MAD-2022-12376672 briefTitle: Dissecting the Molecular and Cellular Pathophysiology of Sarcopenic Obesity in the Elderly overallStatus: RECRUITING date: 2023-05-22 date: 2024-10-31 date: 2024-12-31 date: 2024-03-20 date: 2024-03-28 name: IRCCS San Raffaele class: OTHER briefSummary: Ageing is characterised by a change in body composition with a parallel decrease in muscle mass and an increase and central redistribution of fat. When drastically exacerbated, these two processes culminate in a condition known as sarcopenic obesity (SO). SO is characterised by the coexistence of obesity and sarcopenia (i.e. reduced muscle mass and function) and is a growing public health problem in the elderly. The health risks of obesity and sarcopenia act synergistically, maximising the risk of disability of OS. The molecular mechanisms underlying OS are largely unknown. Increased fat mass induces chronic systemic inflammation and alters the profiles of adipokines and hormones, promoting the development of sarcopenia. On the other hand, the reduction in muscle tissue (SM) typical of sarcopenia is characterised by an alteration in the metabolic properties of skeletal muscle with an increase in insulin resistance and a reduction in energy expenditure that favours the accumulation and dysfunction of adipose tissue (AT). The cellular alterations that would seem to underlie OS are: altered autophagy, cellular senescence, epigenetic and mitochondrial alterations and maladaptive activation of intra- and intercellular inflammatory circuits (e.g. cytokines, extracellular vesicles, dysfunctional circulating leukocytes). However, the interconnections between these mechanisms are still unclear. The impact of OS can be dramatic on the health and quality of life of those affected. Therefore, the identification of early biomarkers that can recognise overweight and obese individuals at risk of developing SO is of paramount importance. This would shed light on the heterogeneity of an otherwise homogeneous clinical condition, opening new horizons towards the conscious design of more personalised therapeutic strategies, allowing a more rational use of the limited resources available for the growing elderly population.

The study design designed to achieve this aim is a cross-sectional observational study with an additional multicentre procedure lasting two years. conditions: Sarcopenic Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1108 type: ESTIMATED name: clinical evaluation of sarcopenic obesity measure: Identifying new molecular markers in elderly patients with sarcopenic obesity measure: Assessing the ability of new markers (identified in the pre-clinical phase of this project) to predict individual disease trajectories sex: ALL minimumAge: 65 Years maximumAge: 99 Years stdAges: OLDER_ADULT facility: Ospedale San Raffaele status: RECRUITING city: Milan zip: 20132 country: Italy name: Patrizia Rovere Querini, MD, PhD role: CONTACT phone: +390226433065 email: rovere.patrizia@hsr.it name: Rebecca De Lorenzo, MD role: CONTACT phone: +390226433065 email: delorenzo.rebecca@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06320145 id: P.T.REC/012/004045 briefTitle: Effect of Cryotherapy on Primary Dysmenorrhoea overallStatus: COMPLETED date: 2023-03-13 date: 2023-09-13 date: 2023-10-01 date: 2024-03-20 date: 2024-03-20 name: Cairo University class: OTHER briefSummary: Dysmenorrhea is a menstrual disorder defined by the presence of painful cramps of uterine origin that occur during menstruation. It is one of the most common causes of pelvic pain and short-term absenteeism from school or work, among young and adult women.

Cryotherapy, therapeutic cooling, is one of the modalities widely used in sports medicine for a variety of treatment purposes. Physiological and neurological responses of musculoskeletal tissues to cooling have been extensively examined in the literature. conditions: Dysmenorrhea Primary studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Cryotherapy name: core stability exercises measure: Pain assessed by VAS sex: FEMALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Faculty of Physical Therapy,Cairo University city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06320132 id: BLANDISH briefTitle: BLANDISH (Brain, Loss of Function, Aneurism, Disease, Injury, Stroke, Hemorrhage) acronym: BLANDISH overallStatus: RECRUITING date: 2024-03-13 date: 2028-12-31 date: 2029-01-31 date: 2024-03-20 date: 2024-03-20 name: IRCCS Ospedale San Raffaele class: OTHER briefSummary: The goal of this observational study is to train a machine learning system based on data from patients affected by spontaneous Intracranial Hemorrage. The main question it aims to answer is whether there is a correlation between actual clinical pratice, reached outcomes and favorable or unfavorable predictive factors, and anamnesis.

Participants will be treated as per standard clinical practice. conditions: Intracranial Hemorrhages studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 2000 type: ESTIMATED name: Treatment of spontaneous intracranial hemorrhage measure: Mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale San Raffaele status: RECRUITING city: Milano state: MI country: Italy name: Francesca Guzzo, MD role: CONTACT phone: +393470830669 phoneExt: +390226433333 email: guzzo.francesca@hsr.it name: Margherita Tozzi, MD role: CONTACT phone: +393343138755 phoneExt: +390226433333 email: tozzi.margherita@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06320119 id: 2943 briefTitle: Setting a PERSONalized Outcome in ASthma: the PERSONAS Study. A Patient Driven Outcome (PDO) Study acronym: PERSONAS overallStatus: RECRUITING date: 2023-01-01 date: 2025-01-15 date: 2025-09-30 date: 2024-03-20 date: 2024-04-11 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: To optimize the effectiveness of asthma therapy there is a need to identify and address individual patient goals. Considering the self-management discussion as central for the achievement of health outcomes, Healthcare Providers may help patients make specific actions to obtain their desired goals.

The current evidence suggest that Healthcare Professionals need to develop a more patient-centered and partnership-based approach based on the development and review of action plans, including the experiential asthma knowledge of patients and caregivers. From a practical perspective, the specialist (i.e. pulmunologists, allergologists, etc) has clear therapeutic targets to be reached in asthmatic patients: for example, improving the disease control, the spirometric values and asthma control test (ACT) score vs. pre-treatment evaluations represent the standard outcomes to reach (GINA 2019). However, as previously described, patients are more likely to achieve an improved clinical outcome when the treatment is driven by a personalized goal. This builds on the same principle as shared decision making between the physician and patient, recognizing both the personal motivation and the accountability on behalf of the patient (Hoskins et al. 2016).

This study aims to evaluate if the identification of a personalized outcome allows patients to achieve a better control of asthma in terms of asthma control test (ACT) and asthma quality of life questionnaire (AQLQ). In addition, a set of clinical outcomes (i.e. forced expiratory volume in one second - FEV1, use of rescue therapy, night awakeness) will also be assessed. conditions: Bronchial Asthma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 190 type: ESTIMATED name: PDO Group measure: Primary Outcome. The primary outcome of the study is to evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group). measure: Secondary Outcome. To evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group) assessed by the change of ACT from month 3 to month 6. measure: Secondary outcome. To evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group) assessed by the change of AQLQ from baseline to month 3. measure: Secondary outcome. To evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group) assessed by the change of AQLQ from month 3 to month 6. measure: Secondary outcome. To evaluate the impact of the personalized approach on asthma control assessed by the change of lung function (pulmonary functions tests: FEV1, FVC, FEV1/FVC) from baseline to month 3. measure: Secondary outcome. To evaluate the impact of the personalized approach on asthma control assessed by the change of lung function (pulmonary functions tests: FEV1, FVC, FEV1/FVC) from baseline from month 3 to month 6. measure: Secondary outcome. To measure the proportion of patients in the PDO group who achieve their own personal outcome at month 3, assessed by VAS (1-10) to V1. measure: Secondary outcome. To measure the proportion of patients in the PDO group who achieve their own personal outcome at month 6, assessed by a VAS (1-10) as minimal clinically important difference (MCID) of 1.5 points to V1. measure: Secondary outcome. To measure the proportion of patients in the PDO group who maintain/improve their own personal outcome at month 6, assessed by a VAS (1-10) to V2. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASST Papa Giovanni XXIII status: RECRUITING city: Bergamo zip: 24127 country: Italy name: Fabiano Di Marco, Prof. role: CONTACT lat: 45.69601 lon: 9.66721 facility: Azienda ospedaliera Spedali Civili di Brescia status: RECRUITING city: Brescia zip: 25123 country: Italy name: Laura Pini, Prof. role: CONTACT lat: 45.53558 lon: 10.21472 facility: Ospedale San Martino di Genova status: RECRUITING city: Genova zip: 16132 country: Italy name: Fulvio Braido, Prof. role: CONTACT lat: 44.40478 lon: 8.94438 facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano status: RECRUITING city: Milano zip: 20122 country: Italy name: Francesco Blasi, Prof. role: CONTACT phone: +390250320627 email: francesco.blasi@unimi.it lat: 45.46427 lon: 9.18951 facility: ASST Fate Bene e Fratelli Sacco status: RECRUITING city: Milan zip: 20100 country: Italy name: Pierachille Santus role: CONTACT lat: 45.46427 lon: 9.18951 facility: ASST Grande Ospedale Metropolitano Niguarda status: NOT_YET_RECRUITING city: Milan zip: 20100 country: Italy name: Paolo Tarsia, Prof. role: CONTACT lat: 45.46427 lon: 9.18951 facility: ASST Santi Paolo e Carlo status: RECRUITING city: Milan zip: 20100 country: Italy name: Stefano Centanni, Prof. role: CONTACT lat: 45.46427 lon: 9.18951 facility: Policlinico San Matteo status: RECRUITING city: Pavia zip: 27100 country: Italy name: Angelo Corsico, Prof. role: CONTACT lat: 45.19205 lon: 9.15917 facility: Ospedale di Rovigo status: RECRUITING city: Rovigo zip: 45100 country: Italy name: Gianluca Casoni, Dott. role: CONTACT lat: 45.06982 lon: 11.79022 facility: Humanitas Hospital - UO Allergologia status: RECRUITING city: Rozzano zip: 20089 country: Italy name: Enrico Heffler role: CONTACT lat: 45.38193 lon: 9.1559 facility: Humanitas Hospital - UO Pneumologia status: NOT_YET_RECRUITING city: Rozzano zip: 20089 country: Italy name: Stefano Aliberti, Prof. role: CONTACT lat: 45.38193 lon: 9.1559 facility: Istituti Clinici Scientifici Maugeri, IRCCS Tradate status: RECRUITING city: Tradate zip: 21049 country: Italy name: Antonio Spanevello, Prof. role: CONTACT lat: 45.70843 lon: 8.90763 hasResults: False

 nctId: NCT06320106 id: GIP 1021 briefTitle: Assessment of Navigation Abilities in Children With Cerebral Palsy and Their Peers overallStatus: RECRUITING date: 2023-02-07 date: 2025-01-31 date: 2025-01-31 date: 2024-03-20 date: 2024-03-20 name: IRCCS Eugenio Medea class: OTHER briefSummary: Spatial navigation skills are very important in everyday activities and quality of life but spatial navigation abilities are not part of the standard process of assessment and rehabilitation of patients. Furthermore, it is known that children with cerebral palsy have impaired visuo-spatial competences. The main objective of this study is to evaluate and compare the spatial navigation abilities of typically developing children and of children with cerebral palsy using the "StarMaze" application delivered by means of a Head Mounted Display (HMD). The second aim is to investigate the user experience during the session. A similar application was already developed and tested in a virtual reality large scale platform whose size and cost limit the accessibility. Therefore, the assessment (and future training) of navigation abilities with affordable and easy-to-use technology such as HMD open new perspectives. conditions: Cerebral Palsy conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 26 type: ESTIMATED name: Virtual Reality baseline assessment measure: Navigation strategy measure: Learning rate measure: Simulator Sickness Questionnaire measure: System Usability Scale measure: Independent Television Commission-Sense of Presence Inventory measure: Suitability Evaluation Questionnaire - simplified version measure: Short-form of PANAS-Positive Affect and Negative Affect Scales sex: ALL minimumAge: 13 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Scientific Institute, IRCCS E. Medea status: RECRUITING city: Bosisio Parini state: Lecco zip: 23842 country: Italy name: Emilia Biffi, PhD role: CONTACT phone: +39 31877862 email: emilia.biffi@lanostrafamiglia.it name: Emilia Biffi, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.80075 lon: 9.29 hasResults: False

 nctId: NCT06320093 id: INRCA_002_2024 briefTitle: Training Social and Health Care prOfessionals in mUsic-based Therapeutic iNterventions to Support Older People With Dementia acronym: SOUND overallStatus: COMPLETED date: 2023-10-03 date: 2024-02-20 date: 2024-02-20 date: 2024-03-20 date: 2024-03-20 name: Istituto Nazionale di Ricovero e Cura per Anziani class: OTHER name: European Union briefSummary: The study will investigate the effects of an inovative intervention based on the use of music on 45 professionals in the field of dementia, 45 elderly people with dementia. conditions: Dementia conditions: Older People studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 45 type: ACTUAL name: SOUND Intervention measure: Change in mental wellbeing of patients with dementia measure: Change in cognitive status of patients with dementia measure: Change in stress of health care providers sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: INRCA Hospital city: Ancona zip: 60127 country: Italy lat: 43.5942 lon: 13.50337 facility: Sons do Estamine Associacao city: Trofa country: Portugal facility: Associatia Habilitas city: Bucarest country: Romania lat: 44.43225 lon: 26.10626 hasResults: False

 nctId: NCT06320080 id: TQB2223-AK105-Ib-01 briefTitle: Clinical Study of TQB2223 Injection Combined With AK105 Injection in the Treatment of Advanced Hepatocellular Carcinoma. overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2025-10 date: 2024-03-20 date: 2024-03-20 name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: TQB2223 is a recombinant, fully human antibody that binds to lymphocyte activation gene-3 (LAG-3) and blocks the LAG-3/ major histocompatibility complex class II (MHC-II) interaction, thus allowing for increased T-cell proliferation and cytokine production. This is a phase Ib study aimed at evaluating the safety, tolerability, and immunogenicity characteristics of TQB2223 injection combined with AK105 injection in the treatment of advanced hepatocellular carcinoma. conditions: Advanced Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 34 type: ESTIMATED name: TQB2223 injection name: Penpulimab Injection measure: Objective Response Rate (ORR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Disease control rate (DCR) measure: Duration of Response (DOR) measure: Number of patients with adverse events (AEs) and/or serious adverse events (SAEs) measure: Immunogenicity sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Cancer Hospital of Harbin Medical University city: Harbin state: Heilongjiang zip: 150000 country: China name: Zhiwei Li, Doctor role: CONTACT phone: 15004683651 email: lzhw0451@163.com lat: 45.75 lon: 126.65 facility: Hubei Provincial Tumor Hospital city: Wuhan state: Hubei zip: 430079 country: China name: Feng Zhang, Doctor role: CONTACT phone: 13871410719 email: zhangfeng_329@126.com lat: 30.58333 lon: 114.26667 facility: Hunan Provincial Tumor Hospital city: Changsha state: Hunan zip: 410031 country: China name: Shanzhi Gu, Master role: CONTACT phone: 13574865998 email: 105575191@qq.com lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06320067 id: PR12 id: 1006437 type: OTHER domain: IRAS briefTitle: A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer acronym: STAMPEDE2 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2031-04 date: 2034-03 date: 2024-03-20 date: 2024-03-20 name: University College, London class: OTHER name: Cancer Research UK name: Novartis name: Janssen Pharmaceutica NV briefSummary: STAMPEDE2 is a clinical trial comparing three new treatments with standard of care in people with prostate cancer that has spread to other parts of the body and is responsive to hormone therapy. People from all backgrounds and ethnicities are encouraged to take part and multiple hospitals across the UK are involved. University College London is running the trial.

Each comparison within the trial has its own control arm where people get the best standard of care (Arm A) versus a research arm where a new treatment is added to standard of care.

Participants are allocated to an arm by a computerised system with a 50% chance of getting the research treatment.

Comparison S: Arm A versus Arm S (Stereotactic Ablative Body Radiotherapy (SABR)) - Tests whether giving targeted doses of radiotherapy (SABR) to parts of the body where the cancer has spread slows the spread of the cancer and improves survival. 2476 people will be in this comparison.

Comparison P: Arm A versus Arm P (PSMA-Lutetium (177Lu-PSMA-617)) - Tests whether giving a radioactive material (177Lu-PSMA-617) that targets prostate cancer cells slows the spread of the cancer and improves survival. 1756 people will be in this comparison.

Comparison N: Arm A(N) versus Arm N (Niraparib-Abiraterone Acetate+Prednisolone (Nira-AA+P)) - Tests whether giving a new drug (Nira-AA+P) slows the spread of the cancer and improves survival. Only people with certain genetic changes in their tumour sample can take part in Comparison N. 682 people will be in this comparison.

Participants may be able to take part in more than one comparison.

All participants will be followed up with scans and tests to monitor their cancer. Doctors will check for any side effects from the treatments. Treatments will be stopped if side effects are serious, or people no longer wish to take the treatments. conditions: Prostate Cancer Metastatic studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Platform trial testing three research comparisons where patients are randomised either to experimental treatments in Arms S, P and N or their corresponding SoC control Arms A and A(N). primaryPurpose: TREATMENT masking: NONE count: 8000 type: ESTIMATED name: Stereotactic Ablative Body Radiotherapy (SABR) name: 177Lu-PSMA-617 name: Niraparib and Abiraterone Acetate Dual Action Tablet DAT name: Abiraterone Acetate name: Apalutamide name: Androgen Deprivation Therapy (ADT) name: Androgen Receptor Signalling Inhibitor (ARSI) name: Local Radiotherapy name: Prednisolone name: Docetaxel measure: Radiographic Progression-Free-Survival (rPFS) measure: Overall Survival (OS) measure: Failure-Free Survival (FFS) measure: Prostate cancer specific survival (PCSS) measure: Safety through reporting of SAEs measure: Toxicity using CTCAE classification and reporting of all Adverse Events that are ≥ grade 3 or grade 1 and 2 leading to a change in trial treatment measure: Compliance with randomised allocation. Formal definitions for compliance with treatment will be pre-specified in the statistical analysis plan. This is still in development. measure: EQ-5D-5L questionnaire for QoL and cost effectiveness assessment sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06320054 id: PRO00049771 briefTitle: Preventing Obstetric Complications With Dietary Intervention acronym: PLATE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-30 date: 2025-08-31 date: 2024-03-20 date: 2024-03-20 name: Medical College of Wisconsin class: OTHER name: Advancing a Healthier Wisconsin Endowment name: Food for Health, Inc. briefSummary: The goal of this study is to learn whether access to healthy and fresh food, health coaching, and nutrition support intervention can reduce adverse birth outcomes in pregnant women. The main questions it aims to answer are:

* Does access to healthy and fresh food, health coaching and nutrition support reduce the risk of gestational diabetes or preeclampsia and ultimately improve health outcomes for mothers and their newborns?
* Are participants able to successfully utilize the health program? Are participants satisfied and self-equipped to apply the teachings of the program within their lives following their participation in the study? Participants will be randomly assigned to one of two groups.

Participants in the standard of care will be asked to:

* Complete surveys
* Biometric screenings

Participants in the intervention group will be asked to:

* Complete surveys
* Biometric screenings
* Participate in weekly personal health coaching
* Receive and consume provided weekly meals.

Researchers will compare the standard of care to those who receive the intervention to see the impact of the intervention on clinical outcomes including: gestational weight gain, blood pressure, diagnosis of gestational diabetes, diagnosis of gestational hypertension or preeclampsia, and gestational age at birth. conditions: Gestational Diabetes conditions: Gestational Hypertension conditions: High Risk Pregnancy conditions: Preeclampsia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: Maternal Health Management Program measure: Clinical Outcomes measure: Clinical Outcomes measure: Clinical Outcomes measure: Clinical Outcomes measure: Clinical Outcomes measure: Patient Reported Outcomes measure: Patient Reported Outcomes measure: Patient Reported Outcomes measure: Patient Reported Outcomes measure: Patient Reported Outcomes sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06320041 id: KY-2024-028 briefTitle: Efficacy and Safety of Oliceridine for Moderate to Severe Acute Pain After Orthopedic Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-30 date: 2024-12-31 date: 2024-03-20 date: 2024-03-20 name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: The goal of this clinical trial\] is to further explore the effectiveness and safety of oxelidine in the treatment of moderate to severe acute pain after orthopedic surgery. The main question it aims to answer is: Pain management after orthopaedic surgery provides more effective and safe drug options, provides new options for clinical treatment, and provides a scientific basis for clinical practice.

Participants will be asked to pain score in the different time, treatments they'll be given and use optimal drug. Researchers will compare analgesic effect of oxelidine of different dose. conditions: Postoperative Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 162 type: ESTIMATED name: Low dose oxelidine group name: High dose oxelidine group name: Hydromorphone group measure: Pain score at rest 0-72 hours after surgery measure: The total amount of opioid after operation. measure: PCIA as a remedial analgesic press time sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06320028 id: 019782-00001 briefTitle: Altering Default Mode Network Activity With Transcranial Focused Ultrasound to Reduce Depressive Symptoms acronym: DMNtFUS overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-27 date: 2024-01-03 date: 2024-06-03 date: 2024-03-20 date: 2024-03-20 name: University of Arizona class: OTHER name: Openwater briefSummary: Depression is a leading cause of disability worldwide, affecting roughly 21 million adults. Repetitive Negative Thought (RNT) has been identified as a potential maintaining factor in depression, such that those who exhibit higher degrees of RNT endorse greater symptoms. Research also suggests that the Default Mode Network (DMN), responsible for self-referential processing, plays an important role in depression wherein it has been linked to RNT. In depressed individuals, this network appears to be hyper-connected, or "too connected", within itself which, in turn, is thought to promote RNT.

Half of depressed individuals are treatment-resistant, creating a critical need to identify more effective interventions derived from a better mechanistic understanding of the development and maintenance of depression. Non-invasive Transcranial-Focused Ultrasound Stimulation (tFUS) is promising for the treatment of depression. tFUS directs a low-intensity (nonthermal) focused ultrasound beam that passes safely through the skull. Compared to other noninvasive neuromodulation approaches, tFUS can target deeper brain regions with high spatial precision.

The present study is an exploratory non-blinded single treatment study to investigate whether tFUS targeting a major hub of the DMN, the anterior-medial prefrontal cortex, can improve depression symptoms and reduce RNT. Twenty depressed individuals with high RNT (75th percentile) will complete up to eleven ultrasound sessions targeting the anterior medial prefrontal cortex, a hub of the brain's default mode network that has been found to be hyper-connected in depression. MRI scans will be obtained before the first and after the last ultrasound sessions. Based on previous literature, it is predicted that depression interview ratings and self-report symptoms will decrease after the intervention, and also that DMN connectivity will decrease following intervention. conditions: Depressive Disorder, Major conditions: Depression studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All participants will receive the same treatment protocol. primaryPurpose: TREATMENT masking: NONE maskingDescription: There is no masking. count: 20 type: ACTUAL name: Non-Invasive Transcranial Focused Ultrasound measure: Beck Depression Inventory - II (BDI-II) measure: Perseverative Thinking Questionnaire (PTQ) measure: Hamilton Depression Rating Scale (HDRS) measure: Default Mode Network (DMN) Connectivity measure: The Montgomery-Åsberg Depression Rating Scale (MADRS) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of Arizona city: Tucson state: Arizona zip: 85721 country: United States lat: 32.22174 lon: -110.92648 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-01-13 uploadDate: 2024-03-13T20:19 filename: SAP_000.pdf size: 123058 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-12-22 uploadDate: 2024-01-17T15:37 filename: ICF_001.pdf size: 159488 hasResults: False

 nctId: NCT06320015 id: R01CE003632-01-00 id: R01CE003632 type: NIH link: https://reporter.nih.gov/quickSearch/R01CE003632 briefTitle: Emergency Medicine Peer Outreach Worker Engagement for Recovery acronym: EMPOWER overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-01 date: 2025-09 date: 2024-03-20 date: 2024-03-20 name: University of California, Los Angeles class: OTHER name: Rhode Island Hospital name: The Miriam Hospital name: Brown University briefSummary: This is an observational, prospective case-control study evaluating the effects of an emergency department community health worker-peer recovery specialist program (PCHW), the Substance Misuse Assistance Response Team (SMART). Aims of this study are to 1) understand participant experiences working with a SMART PCHW and identify possible mechanisms for successful recovery linkage; 2) Evaluate SMART effectiveness on patient-centered outcomes, building recovery capital, and recovery linkage; 3) Evaluate SMART implementation and effectiveness on patient outcomes over time.

Using a combination of surveys and data linkages to state administrative databases, study investigators will prospectively compare changes in addiction treatment engagement, recovery capital, health related social needs, acute care utilization, and death between people receiving a ED PCHW and those who do not. After consenting to study participation, participants will complete surveys at time of study enrollment and 3 and 6 months after their initial ED visit. Primary outcomes include engagement in addiction treatment, social services engagement, acute care utilization, and mortality will be assessed through linkages to state administrative databases. conditions: Substance Use Disorders conditions: Overdose conditions: Opioid Use Disorder conditions: Alcohol Use Disorder studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Substance Misuse Assistance Response Team (SMART) measure: Treatment engagement measure: Recovery Capital measure: Emergency Department Utilization measure: Repeat Hospitalization measure: Repeat Overdose measure: Mortality measure: Social Services Engagement measure: Housing Services Engagement measure: Employment measure: Incarceration sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06320002 id: 2023P003564 briefTitle: Communication Intervention for Fecal Ostomy Surgery acronym: CI-oSurg overallStatus: RECRUITING date: 2024-03-18 date: 2024-07-31 date: 2024-08-30 date: 2024-03-20 date: 2024-03-28 name: Massachusetts General Hospital class: OTHER briefSummary: In this study the investigators will evaluate the acceptability of a communication intervention for fecal ostomy surgery (CI-oSurg) to address the needs of adults who are undergoing fecal ostomy surgery. The investigators will recruit 24 patients and 4 clinicians (surgical nurses, wound ostomy nurses). At least half of patients are 65 years or older to understand the unique needs of older adults recovering from fecal ostomy surgery that might impact intervention acceptability. Questionnaires will be administered at two time-points for patient participants: upon study start and 4 weeks after exposure to the intervention. conditions: Surgery conditions: Colostomy Stoma conditions: Ileostomy - Stoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 28 type: ESTIMATED name: Communication Intervention for fecal ostomy surgery measure: Intervention Acceptability measure: Intervention Usability measure: Emotional Distress measure: World Health Organization Brief quality of life evaluation measure: Hospital Anxiety and Depression Scale measure: Therapy Evaluation Form measure: Client Satisfaction Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Christy E Cauley, MD role: CONTACT phone: 617-726-8129 email: ccauley@mgb.org lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06319989 id: IRB202301905 briefTitle: The Efficacy of Biplane Versus Single Plane Ultrasound in Facilitating Caudal Epidural Anesthesia in Pediatric Patients. overallStatus: NOT_YET_RECRUITING date: 2024-05-25 date: 2026-03-25 date: 2026-09-30 date: 2024-03-20 date: 2024-04-16 name: University of Florida class: OTHER briefSummary: Ultrasound guidance plays a pivotal role in caudal epidural block in pediatric patients. In comparison to conventional single-plane ultrasound, biplane ultrasound offers the advantage of providing simultaneous transverse and longitudinal imaging. Better visualization under biplane ultrasound is postulated to enhance the efficacy of caudal epidural blocks. This improvement is expected to manifest through higher first puncture success rate, shorter procedure time, and longer time to first postoperative analgesics use. conditions: Educational Problems studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective, randomized, parallel study to assess the efficacy of biplane ultrasound-guided caudal epidural anesthesia in pediatric patients. primaryPurpose: OTHER masking: NONE maskingDescription: The intervention group will receive caudal epidural block under the guidance of biplane ultrasound. The procedures for patients in the control group will be guided by conventional single-plane ultrasound. count: 281 type: ESTIMATED name: Biplane Ultrasound name: Single plane ultrasound measure: First puncture success measure: Number of Needle redirections measure: Duration of epidural measure: Postoperative analgesic use sex: MALE minimumAge: 4 Months maximumAge: 10 Years stdAges: CHILD hasResults: False

 nctId: NCT06319976 id: P.T.REC/012/004883 briefTitle: Effect of Rotator Cuff Training on Hand Grip in Adults overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-10-30 date: 2024-12-30 date: 2024-03-20 date: 2024-03-20 name: Cairo University class: OTHER briefSummary: Purpose of the study:

* To investigate the effect of rotator cuff training on hand grip strength in adults with different body mass index.
* To investigate the effect of rotator cuff training on hand grip static endurance in adults with different body mass index.
* To investigate the effect of rotator cuff training on hand grip dynamic endurance in adults with different body mass index.
* To investigate the effect of rotator cuff training on upper limb function in adults with different body mass index. conditions: Hand Grasp studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: open chain exercises for rotator cuff muscles name: Advices for postural correction measure: Hand grip strength measure: Hand grip static endurance measure: Hand grip dynamic endurance measure: Upper limb function sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06319963 id: Lenti-HPV-07-CT01 briefTitle: A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2026-12 date: 2024-03-20 date: 2024-03-20 name: Theravectys S.A. class: INDUSTRY briefSummary: The goal of this clinical trial is to learn about the safety and efficacy of a potential new treatment called Lenti-HPV-07 in patients with a cancer induced by Human Papilloma Virus (HPV).

The main questions aim to answer are:

* Is Lenti-HPV-07 safe?
* Does Lenti-HPV-07 induce an immune response?

Participants will be assigned to a group based on their cancer type

* either study drug group A: recurrent and/or metastatic cancer
* or study drug group B: newly diagnosed with locally advanced cancer

After they finish the study treatment, they will be followed for up to 1 year. Follow-up visits will occur via clinic visits or phone calls 4 weeks after the last study treatment and then quarterly for up to 1 year. conditions: HPV-Related Cervical Carcinoma conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Phase 1/2a, open label, multicenter, dose-escalation and dose expansion trial to assess the safety, tolerability, and preliminary efficacy of Lenti-HPV-07 to participants with HPV associated oropharyngeal squamous cell cancer or cervical cancer. Three dose strengths will be investigated: a low, midlevel, and high dose. Lenti HPV-07 will be administered as either 2 × intramuscular (IM) injections to participants in arm A (recurrent or metastatic stage, refractory to previous treatments) or as a single IM injection to participants in Arm B (newly diagnosed with locally advanced HPV+ cancer never treated). Eligible participants in Arm B will receive only 1 injection of Lenti-HPV-07 prior to the initiation of their standard of care (SoC) therapy. After 18 participants in either arm have been treated in the escalation phase and have completed the 14 day DLT period, the Safety Review Committee and Sponsor will determine the OBD for use in the dose expansion phase. primaryPurpose: TREATMENT masking: NONE count: 72 type: ESTIMATED name: Two IM injections Lenti-HPV-07 name: One IM injection Lenti-HPV-07 measure: Safety and Tolerability measure: OBD measure: Immunogenicity measure: PD-L1 expression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Florida Cancer Specialists (from Sarah Canon research Institute) city: Orlando state: Florida zip: 32827 country: United States name: Cesar Augusto Perez Batista, MD role: PRINCIPAL_INVESTIGATOR lat: 28.53834 lon: -81.37924 hasResults: False

 nctId: NCT06319950 id: 20240229 briefTitle: High-dose Furmonertinib Versus Osimertinib in Advanced EGFRm NSCLC Patients With Brain Metastases overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-30 date: 2026-12-30 date: 2024-03-20 date: 2024-03-20 name: Taizhou Hospital class: OTHER briefSummary: The investigators were to explore whether high-dose Furmonertinib, compared with osimertinib, could achieve longer survival in patients with EGFR-mutated NSCLC with CNS metastasis. conditions: Lung Cancer, Nonsmall Cell studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 255 type: ESTIMATED name: Furmonertinib name: Osimertinib measure: progression free survival(PFS) measure: objective response rate(ORR) measure: Intracranial objective Response Rate(iORR) measure: Intracranial progression free survival(iPFS) measure: overal survival time(OS) measure: Disease control rate(DCR) measure: Intracranial disease control rate(iDCR) measure: Depth of response (DepOR) measure: Depth of intracranial response(iDepOR) measure: Time to intracranial remission(iTTR) measure: Duration of response(DoR) measure: Duration of intracranial response(iDoR) measure: Rate of improvement in neural function measure: Health-related quality of life measure: Adverse events measure: Dynamic changes of ct-DNA sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06319937 id: OA2023 briefTitle: Muscle Architecture in Knee Osteoarthritis overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2025-09-01 date: 2024-03-20 date: 2024-03-20 name: Hacettepe University class: OTHER briefSummary: Background: The aim of this study was to compare the knee and ankle muscle architecture and plantar pressure distribution differences in knee osteoarthritis (OA) women with healthy women.

Methods: Fifty women with knee OA (Mean age=52.11±4.96 years, mean BMI=30.94±4.23 kg/m2) and fifty healthy women (Mean age= 50.93±3.78 years, mean BMI=29.06±4.82 kg/m2) were included in the study. Ultrasonography was used to evaluate Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Peroneus Longus (PL), Tibialis Anterior (TA), and Medial Gastrocnemius (MG) muscle thickness, pennation angle, fascicle length, and fat thickness. The plantar pressure distribution was evaluated using the Digital Biometry Scanning System and software (DIASU, Italy). conditions: Knee Osteoarthritis conditions: Foot Deformities conditions: Muscle Weakness conditions: Kinesiophobia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: Ultrasound measure: Muscle thickness measure: Pennation angle measure: Fat thickness measure: Stair climbing test measure: Sit-stand test sex: FEMALE minimumAge: 45 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06319924 id: XIMEPEG-RL briefTitle: Fixed Low-dose Simethicone Combined With Macrogol 4000 (PEG) Reduces Colon Bubble Formation in Colonoscopy acronym: XIMEPEG-RL overallStatus: COMPLETED date: 2020-02-01 date: 2021-05-31 date: 2022-09-15 date: 2024-03-20 date: 2024-03-20 name: Hospital St. Joseph, Marseille, France class: OTHER briefSummary: Several randomised studies have shown that the addition of low-dose Simethicone to the bowel preparation was sufficient to reduce the presence of bubbles during colonoscopy. The aim of this study was to evaluate the efficacy and safety of a bowel preparation containing low-dose Simethicone on bubble formation.

Patients and Methods This prospective, real-life, phase 4 study was conducted from February 2020 to May 2021, in five private endoscopy centres, among adult patients undergoing a colonoscopy. Clinical, endoscopic and histological parameters were collected on e-CRF. The primary endpoint was the measurement of bubble formation in the various colon segments. conditions: Colorectal Cancer conditions: Colonoscopy conditions: Bowel Preparation Solution studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 601 type: ACTUAL name: Simethicone combined with Macrogol 4000 (PEG) measure: Assess the quality of the bowel preparation assessed by Bubble scale measure: Assess the quality of the bowel preparation assessed by Boston Bowel Preparation Scale (BBPS) measure: Colonoscope removal time measure: The frequency of adverse events (AEs) measure: volume of bowel preparation ingested measure: Caecal intubation rate sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique des Cèdres, Ramsay Santé, city: Cornebarrieu zip: 31700 country: France lat: 43.64895 lon: 1.32407 facility: Polyclinique Louis Pasteur, city: Essey-les-Nancy zip: 54280 country: France lat: 48.70179 lon: 6.22425 facility: Saint Joseph Hospital city: Marseille zip: 13008 country: France lat: 43.29551 lon: 5.38958 facility: 5. Clinique Ambroise Paré city: Toulouse zip: 31082 country: France lat: 43.60426 lon: 1.44367 facility: Pole Santé des Haberges city: Vesoul zip: 70000 country: France lat: 47.63333 lon: 6.16667 hasResults: False

 nctId: NCT06319911 id: AETOS 2022.04 briefTitle: AETOS Shoulder System overallStatus: RECRUITING date: 2024-03-31 date: 2027-08-30 date: 2030-08-30 date: 2024-03-20 date: 2024-03-20 name: Smith & Nephew, Inc. class: INDUSTRY briefSummary: The goal of this study is to confirm the safety and performance of the AETOS Shoulder System for USA adoption. This is a prospective, open, adaptive, non-comparative, multi-centre investigation enrolling a maximum of 220 subjects in 2 cohorts (anatomic and reverse) at up to 15 sites. No intra-study comparator group will be included, and there will be no randomization conditions: Shoulder Osteoarthritis conditions: Shoulder Arthritis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 220 type: ESTIMATED name: AETOS measure: Implant Survivorship measure: Implant Survivorship at 6 months, 1 year, 3.5 years and 5 years measure: Radiographic Assessment - Glenoid Migration/Subsidence measure: Radiographic Assessment - Glenoid Radiolucency measure: Radiographic Assessment - Humeral Radiolucency measure: Radiographic Assessment - Humeral Migration/Subsidence measure: Radiographic Assessment - Humeral Head Centeredness measure: Radiographic Assessment - Bone Remodeling measure: Radiographic Assessment - Glenohumeral Subluxation measure: Radiographic Assessment - Device Condition: Anatomic measure: Radiographic Assessment - Device Condition: Reverse measure: American Shoulder and Elbow Score (ASES) measure: Constant Murley Score measure: Simple Shoulder Test (SST) measure: Single Assessment Numeric Evaluation (SANE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: California Pacific Orthopedics status: RECRUITING city: San Francisco state: California zip: 94118 country: United States name: Katie Sheehi role: CONTACT phone: 415-668-8010 email: ksheehi@calpacortho.com name: James Kelly, MD role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 facility: Western Orthopaedics status: NOT_YET_RECRUITING city: Denver state: Colorado zip: 80210 country: United States name: Libby Mauter role: CONTACT phone: 303-321-1333 email: lmauter@western-ortho.com name: Armand Hatzidakis role: PRINCIPAL_INVESTIGATOR lat: 39.73915 lon: -104.9847 facility: Hughston Foundation status: NOT_YET_RECRUITING city: Columbus state: Georgia zip: 31909 country: United States name: Cholly Minton role: CONTACT phone: 706-494-3330 email: cminton@hughston.com name: Brent Ponce role: PRINCIPAL_INVESTIGATOR lat: 32.46098 lon: -84.98771 facility: Center for Orthopedics and Neurosurgical Care status: RECRUITING city: Bend state: Oregon zip: 97701 country: United States name: Cody Manriquez role: CONTACT phone: 541-420-0774 email: codymanriquez@gmail.com name: Scott Jacobson, MD role: PRINCIPAL_INVESTIGATOR lat: 44.05817 lon: -121.31531 facility: Rothman Institute status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19107 country: United States name: Brooke Olin role: CONTACT phone: 267-516-9393 name: Matthew Ramsey, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06319898 id: IRB00110787 briefTitle: Relaxing Environment to Lower Anxiety During Onabotulinum Toxin Chemodenervation of the Bladder acronym: RELAX overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2026-02 date: 2024-03-20 date: 2024-03-20 name: Wake Forest University Health Sciences class: OTHER briefSummary: Chemodenervation of the bladder with onabotulinum toxin A is an effective treatment option for patients with refractory urgency urinary incontinence (UUI). It is often performed as an office-based procedure under local anesthesia. Alternatively, it can be performed in the operating room under general anesthesia. The ability to receive intra-detrusor chemodenervation in the office allows patients to avoid the risks associated with general anesthesia and is significantly more cost effective. The procedure, however, is painful and can be anxiety provoking for patients; especially given that patients typically return every six to nine months for repeat injections. Relaxation and distraction techniques are one way to ease patients' anxiety before an office-based procedure. While we do not know exactly how anxiety provoking office bladder chemodenervation is for patients, we do know that anxiety disorders are highly prevalent in women with overactive bladder as a population.

The purpose of this study is to investigate whether women with Urge urinary incontinence (UUI) who receive office intra-detrusor chemodenervation injections performed in a relaxing environment of lavender aromatherapy, calming music, dim lighting, and modest positioning (Relaxing Environment Package) will have decreased anxiety and pain as well as increased post-procedure satisfaction compared to patients who receive chemodenervation in a typical office environment. Also investigate whether exposure to the relaxing environment impacts the well-being of staff involved in these procedures. This study design is a randomized control trial. Women scheduled for office intra-detrusor chemodenervation at Atrium Health women's Care Urogynecology \& Pelvic Surgery - Mercy clinic will be invited to participate. Participants will be randomized to the relaxing environment package or the placebo group after informed consent is obtained and immediately before undergoing intra-detrusor chemodenervation. The participants will complete the pre-procedure visual analog scale (VAS) for anxiety and a VAS for pain at baseline. conditions: Anxiety conditions: Pain conditions: Burnout, Professional studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 84 type: ESTIMATED name: Lavender aromatherapy sticker measure: Mean change in Visual Analog Scale (VAS) Anxiety Scores measure: Visual Analog Scale (VAS) Pain during the chemodenervation procedure measure: Procedure Staff Burnout Scores - Burnout Battery visual analog scale for healthcare worker burnout measure: Patient satisfaction with their procedure experience Scores sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wake Forest University Health Sciences city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Megan Tarr, MD role: CONTACT phone: 704-304-1160 email: megan.tarr@atriumhealth.org lat: 36.09986 lon: -80.24422 hasResults: False

 nctId: NCT06319885 id: SDU project nr. 3110386 id: ID: 158341 type: OTHER_GRANT domain: Trygfonden briefTitle: Text Messaging to Reduce High-risk Alcohol Use Among Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2025-04 date: 2024-03-20 date: 2024-03-20 name: University of Southern Denmark class: OTHER name: Anette Søgaard Nielsen, PhD name: Kjeld Andersen, PhD name: Angelina Mellentin, PhD name: Alexis Kuerbis briefSummary: High-risk drinking is very prevalent among Danes aged 55+. It poses a serious risk to health and independent living, burdening health care systems and family members. Measures to reduce high-risk alcohol use in this growing group at need are urgently needed. A recent small study from the US shows that text messaging reduces high-risk alcohol intake in older adults. The investigators will conduct a pilot study with the same intervention in Denmark, with adaptations to language and culture. The pilot study will investigate among Danish older adults whether text messaging is well-accepted by participants and feasible in terms of reducing 1) high-risk drinking and 2) commonly accompanying problems with daily functioning, social relationships, and mental and physical health. The pilot-trial will include n=60 adults aged 55-80 years who will receive alcohol-related text messages (within a secure app for data protection purposes) over 12 weeks. Assessments will include a baseline assessment and a post-assessment. conditions: Hazardous Alcohol Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants are assigned to either one out of six intervention conditions with different types of text messaging (including one assessment-only control condition). primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Participants are informed in the study material that they are allocated to groups that receive different text messages. They receive no further information on the intervention groups. whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Text messaging measure: High-risk alcohol use (yes/no) measure: WHOQOL-Bref (The World Health Organization Quality of Life Brief Version ) measure: OBSESSIVE-COMPULSIVE DRINKING SCALE (OCDS) measure: Drinker Inventory of Consequences (DrInC-2R) measure: Frequency of alcohol use measure: Amount of alcohol use measure: Heavy drinking days measure: User evaluation (tailor-made) measure: PHQ-9 (Patient Health Questionnaire-9 ) sex: ALL minimumAge: 55 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06319872 id: STUDY00009118 briefTitle: The Effects of Disulfiram (Antabuse®) on Visual Acuity in Patients With Retinal Degeneration overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-15 date: 2025-04-15 date: 2024-03-20 date: 2024-03-20 name: University of Rochester class: OTHER briefSummary: Oral disulfiram (Antabuse®) has been shown to improve image-forming vision in animal models with retinal degeneration due to its ability to decrease Retinoic Acid synthesis and consequently reduce hyperactivity in the inner retina. The investigator will aim to evaluate the impact of oral disulfiram on the vision of patients with retinal degeneration who are being treated with the drug in the management of their concurrent alcohol use disorder. conditions: Alcohol Use Disorder conditions: Retinal Dystrophies conditions: Age-Related Macular Degeneration conditions: Retinitis Pigmentosa conditions: Stargardt Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Oral disulfiram measure: mean change in Best Corrected Visual Acuity (BCVA) score assessed by ETDRS measure: mean change in total contrast sensitivity score using Pelli-Robson charts measure: mean change in light-adapted microperimetry sensitivity assessed using standard MAIA microperimetry equipment measure: mean change in outer retinal thickness assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) measure: mean change in fundus autofluorescence (FAF) measure: number of participants with retinal anatomy changes assessed using fundus photos measure: mean change in visual field perimetry using full-field stimulus test measure: mean change in isopter constriction using Goldmann visual field measure: mean change in size of scotomas using Goldmann visual field measure: mean change in cone and rod latency assessed using Full field electroretinogram (ffERG) measure: mean change in cone and rod amplitude assessed using Full field electroretinogram (ffERG) measure: mean change in cone and rod latency assessed using multifocal electroretinogram (mfERG) measure: mean change in cone and rod amplitude assessed using multifocal electroretinogram (mfERG) measure: mean change in National Eye Institute-Visual Functioning Questionnaire 25 composite score. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Flaum Eye Institute, University of Rochester Medical Center city: Rochester state: New York zip: 14642 country: United States name: Gary Gagarinas role: CONTACT email: gary_gagarinas@urmc.rochestere.edu name: Alex Levin, MD role: PRINCIPAL_INVESTIGATOR lat: 43.15478 lon: -77.61556 hasResults: False

 nctId: NCT06319859 id: N-72-2024 briefTitle: Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2024-10 date: 2024-03-20 date: 2024-03-20 name: Cairo University class: OTHER briefSummary: This study will evaluate the efficacy and safety of intrathecal non-preservative-free morphine and its effect on pain in patients undergoing unilateral inguinal hernia surgeries. conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Morphine name: Placebo measure: Time to first analgesic requirement measure: Nalbuphine consumption measure: Postoperative pain measure: The incidence of other adverse effects sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kasr Alaini hospital city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06319846 id: ZLRK202312 briefTitle: Tirofiban for Patients With intraCranial Artery Stenosis and High-risk Acute Non-disabling Cerebrovascular Events(CHANCE-4） overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-06 date: 2026-06 date: 2024-03-20 date: 2024-03-20 name: Beijing Tiantan Hospital class: OTHER briefSummary: The CHANCE-4 study is a multicenter, double-blind, double-simulation, randomized controlled study. In patients at high-risk for mild ischemic stroke or transient ischemic attack with symptomatic intracranial artery stenosis within 24 hours of onset, we will examine whether treatment with tirofiban for 48 hours reduce the risk of ischemic stroke recurrence within 90 days compared with placebo. conditions: Ischemic Stroke, Acute conditions: TIA conditions: Symptomatic Intracranial Artery Stenosis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 4674 type: ESTIMATED name: Tirofiban name: Tirofiban placebo measure: New ischemic stroke measure: BARC type 3 or type 5 bleeding measure: New ischemic stroke measure: Any new vascular events measure: Proportion of patients with disabling stroke measure: Occurrence and severity of stroke or transient ischemic attack measure: Proportion of patients with aggravated neurological impairment measure: BARC type 3 or type 5 bleeding measure: All bleeding events measure: Death measure: Adverse events or serious adverse events measure: BARC type 2 or type 3 or 5 bleeding sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The 2nd Affiliated Hospital of Harbin Medical University city: Harbin state: Heilongjiang zip: 150086 country: China name: Lihua Wang role: CONTACT phone: 13100881600 email: wanglh211@163.com lat: 45.75 lon: 126.65 facility: People's Hospital of Qihe County city: Dezhou state: Shandong zip: 251199 country: China name: Haitao Li role: CONTACT phone: 13869215737 email: userfiled@126.com lat: 37.45127 lon: 116.31046 facility: Liaocheng People's Hospital（Liaocheng Brain Hospital） city: Liaocheng state: Shandong zip: 252001 country: China name: Xiafeng Yang role: CONTACT phone: 13326356005 email: Cranialnerves@163.com lat: 36.45596 lon: 115.97766 facility: Third People's Hospital of Liaocheng city: Liaocheng state: Shandong zip: 252004 country: China name: Liguo Chang role: CONTACT phone: 17763559299 email: chliguo@163.com lat: 36.45596 lon: 115.97766 facility: Yantai Penglai traditional Chinese medicine hospital city: Yantai state: Shandong zip: 265699 country: China lat: 37.47649 lon: 121.44081 hasResults: False

 nctId: NCT06319833 id: 348CER23 briefTitle: Effects of Brain Breaks on Educational Achievement in School Settings: The Break4Brain Project overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-08 date: 2024-04 date: 2024-07 date: 2024-03-20 date: 2024-03-20 name: University of the Balearic Islands class: OTHER name: Ministry of Science and Innovation name: European Regional Development Fund name: Spanish State Research Agency briefSummary: A total of 600 children between 10 and 12 years of age will be randomized among two experimental conditions: physical activity interacting with a video (n = 300), and sedentary activity (n = 300). The experimental condition will take place in the school settings during the school day through a between-subject design with a total of two measurements, pre, and post-test. Using the latest advances, the transient effects of the experimental conditions on cognitive and academic performance will be measured. The experimental condition was crafted through a qualitative design involving semi-structured interviews with teachers (n = 41) and members of the management team (n = 16), along with questionnaires administered to students (n = 600). To enhance and ensure its sustainability, the same process will be replicated after the intervention. Interviews and questionnaires were meticulously crafted by the RE-AIM framework, and subsequently validated through a rigorous process involving an expert panel (n = 30) utilizing the Delphi methodology. This project has the potential to substantially contribute to the field of acute physical activity and could have a meaningful transference on the educational system. This method might be prescribed as an effective teaching strategy. conditions: Physical Activity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: Physical activity interacting with a video measure: Academic achievement measure: Inhibition-attention and cognitive flexibility measure: Working memory measure: Selective attention measure: Design of active breaks: semi-structured questionnaires measure: Design of active breaks: semi-structured interviews measure: Physical activity patterns measure: Self-report physical activity patterns measure: Self-report sedentary patterns measure: Self-report physical fitness measure: Socioeconomic level measure: Student's behavior measure: Body composition measure: Creativity sex: ALL minimumAge: 10 Years maximumAge: 12 Years stdAges: CHILD facility: University of the Balearic Islands city: Palma state: Balearic Islands zip: 07122 country: Spain lat: 39.56939 lon: 2.65024 hasResults: False

 nctId: NCT06319820 id: 42756493BLC3004 id: 2023-507684-19 type: EUDRACT_NUMBER briefTitle: A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer acronym: MoonRISe-1 overallStatus: RECRUITING date: 2024-04-18 date: 2028-06-28 date: 2028-06-28 date: 2024-03-20 date: 2024-04-25 name: Janssen Research & Development, LLC class: INDUSTRY briefSummary: The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC. conditions: Non-Muscle Invasive Bladder Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 540 type: ESTIMATED name: TAR-210 name: Gemcitabine name: MMC measure: Disease Free Survival (DFS) measure: Time to next Treatment (TTNT) measure: High Grade Recurrence-free Survival (HG RFS) measure: Progression Free Survival (PFS) measure: Rate of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment measure: Number of Participants With Adverse Events (Including Physical Examination, Vital Signs and Laboratory Abnormalities) measure: Overall Survival (OS) measure: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores measure: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores measure: Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-C30 Scores measure: Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-NMIBC24 Scores sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Arkansas Urology status: RECRUITING city: Little Rock state: Arkansas zip: 72211 country: United States lat: 34.74648 lon: -92.28959 facility: Genesis Research LLC status: RECRUITING city: Los Alamitos state: California zip: 90720 country: United States lat: 33.80307 lon: -118.07256 facility: Genesis Research LLC status: RECRUITING city: Sherman Oaks state: California zip: 91411 country: United States lat: 34.15112 lon: -118.44925 facility: MidLantic Urology status: RECRUITING city: Bala-Cynwyd state: Pennsylvania zip: 19004 country: United States lat: 40.00761 lon: -75.23407 facility: Urology Associates status: RECRUITING city: Nashville state: Tennessee zip: 37209 country: United States lat: 36.16589 lon: -86.78444 facility: Urology Austin status: RECRUITING city: Austin state: Texas zip: 78745 country: United States lat: 30.26715 lon: -97.74306 facility: Hadassah University Hospita - Ein Kerem status: RECRUITING city: Jerusalem zip: 9112001 country: Israel lat: 31.76904 lon: 35.21633 hasResults: False

 nctId: NCT06319807 id: IRB00110194 briefTitle: GrowWell - Responsive Bottle Feeding overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2025-02 date: 2024-03-20 date: 2024-03-20 name: Wake Forest University Health Sciences class: OTHER briefSummary: The overall goal of this research is use digital health to augment the clinical encounter with Women, Infants, and Children (WIC) clinicians and prevent rapid infant weight gain among children living in low-income households. Intervening on weight gain during infancy offers an opportunity to influence lifelong obesity risk. Using personalized motivational messages and targeted skills-training resources, the intervention will support parents and caregivers in adopting responsive feeding strategies. Knowledge gained from this project will be used to develop a future, larger grant submission focused on developing healthy feeding and eating habits among mother-infant dyads. conditions: Bottle Feeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Digital Health Intervention name: Safety Control measure: Engagement - average text message completion rate measure: Satisfaction Scores - Acceptability measure: Satisfaction Scores - Frequency measure: Satisfaction Scores - Timing sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wake Forest University Health Sciences city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Melissa C Kay, PhD role: CONTACT phone: 781-249-3062 email: mekay@wakehealth.edu lat: 36.09986 lon: -80.24422 hasResults: False

 nctId: NCT06319794 id: TQR-BTOP-101 briefTitle: Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-20 date: 2024-03-22 name: TORQUR class: INDUSTRY briefSummary: The aim of the study is to evaluate efficacy and safety of bimiralisib gel treatment for treatment of actinic keratosis (AK) on the face and/or scalp and/or back of hands conditions: Actinic Keratosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Bimiralisib name: Bimiralisib measure: Change from baseline in AK lesions as measured by achieving an Investigator Global Assessment (IGA) score of 0 or 1 measure: Proportion of participants with partial or complete clearance of AK lesions at the End of Treatment Visit (Week 2 or 4 depending on treatment arms) measure: Incidence of Treatment-Emergent Adverse Events measure: Incidence of local skin reactions sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Basel / Department of Dermatology city: Basel country: Switzerland name: Alexander Navarini role: CONTACT lat: 47.55839 lon: 7.57327 facility: CHUV centre hospitalier universitaire vaudois / Department of Dermatology and Venereology city: Lausanne country: Switzerland name: Olivier Gaide role: CONTACT lat: 46.516 lon: 6.63282 hasResults: False

 nctId: NCT06319781 id: H-23038433 briefTitle: A Pilot Cohort Study of Risk Factors and Novel Methods of Skin Lesion Assessments in Adults With Atopic Dermatitis, Alopecia Areata, Psoriasis or Vitiligo acronym: Derma-001 overallStatus: RECRUITING date: 2023-12-15 date: 2025-05 date: 2025-05 date: 2024-03-20 date: 2024-03-20 name: Blueskin AS class: INDUSTRY briefSummary: The objective of the study is to explore various clinical and biochemical parameters and their potential associations with disease severity, activity, and prognosis in atopic dermatitis, psoriasis, alopecia areata, and vitiligo. Further, the study aims at validating remote assessments of skin lesions, using smartphone-acquired photos. The study will also assess the feasibility and compliance with weekly remote-assessments and patient-reported data collection over the full study period of one year. The study will observe patients through a period of one year and will provide detailed information concerning the type and dose of medication used, as well as data to evaluate the disease activity with high resolution during this period. The study will involve collection of serum samples for exploratory biomarkers, and punch biopsies. A total of approximately 370 patients, divided into the four disease areas of atopic dermatitis, alopecia areata, psoriasis, and vitiligo, will be enrolled in the study. Using a combination of self-reported and on-site assessments and procedures, the intent is to observe the natural history of patients with select dermatological conditions, investigate tissue characteristics associated with disease activity and symptoms, and evaluate the validity of remote assessment of lesions, and feasibility of weekly self-acquired smart-phone images of skin lesions for remote assessment. conditions: Alopecia Areata conditions: Vitiligo conditions: Atopic Dermatitis conditions: Psoriasis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 370 type: ESTIMATED name: Observational measure: Severity of the disease. measure: Clinical characteristics and disease activity. measure: Tissue profiling and disease activity. measure: Disease activity and biomarkers. measure: Quality of life. measure: Compliance of remote tasks. measure: Quality of smartphone collected photos. measure: Level of agreement between the in-person and remote scoring sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sanos Clinic, Gandrup status: RECRUITING city: Gandrup zip: 9362 country: Denmark name: Cecilie Rovsing, MD role: CONTACT phone: +45 7370 8220 email: info.nordjylland@sanosclinic.com lat: 56.74249 lon: 9.82298 facility: Sanos Clinic, Herlev status: RECRUITING city: Herlev zip: 2730 country: Denmark name: Zarqa Ali, PhD role: CONTACT phone: +45 7370 8200 email: info@sanosclinic.com lat: 55.72366 lon: 12.43998 facility: Sanos Clinic, Vejle status: RECRUITING city: Vejle zip: 7100 country: Denmark name: Randi Kviesgaard Bechmann, MD role: CONTACT phone: +45 7370 8210 email: info.syddanmark@sanosclinic.com lat: 55.70927 lon: 9.5357 hasResults: False

 nctId: NCT06319768 id: soh-med-24-01-04ms briefTitle: Efficacy of Intralesional Injection of Pentoxifylline, Platelet-Rich Plasma, and Combined Pentoxifylline With Platelet-Rich Plasma in Patients With Atrophic Acne Scars overallStatus: RECRUITING date: 2024-01-01 date: 2024-06-15 date: 2024-06-15 date: 2024-03-20 date: 2024-03-20 name: Sohag University class: OTHER briefSummary: Platelet-rich plasma (PRP) is an Acne vulgaris is a common chronic inflammatory skin disorder. It is the eighth most prevalent disease worldwide with a prevalence of 9.4%. Acne scar is one of the most persistent complications of acne, causes marked psychological stress to the patient . The process of acne scar formation can be broadly divided into two stages: increased tissue formation and loss or damage of tissue, corresponding to keloid or hypertrophic scar and atrophic scar, respectively.

The ultimate severity of acne scars is correlated with acne grade and the delay in treatment of active disease. The atrophic scars include three subtypes: icepick or V-shaped, rolling or M-shaped, and boxcar or U-shaped scars. Among atrophic scars, the ice pick type represents 60%-70%; the boxcar type represents 20%-30%; and the rolling type represents 15%-25% (Salameh and Shumaker, 2022). According to the qualitative scarring grading system, a macular acne scar type also exists, which clinically shows erythematous, hyperpigmented, or hypopigmented flat marks.

autologous blood product containing high concentrations of platelets in a small volume of plasma. PRP has been utilized in the treatment of orthopedic, musculoskeletal, and maxillofacial conditions for many years, it has only recently gained popularity in dermatology. PRP contains various growth factors, including platelet-derived growth factor (PDGF), transforming growth factor (TFG), vascular endothelial growth factor (VEGF), and insulin-like growth factor (IGF). These growth factors stimulate tissue remodeling and are associated with enhanced healing through the attraction of macrophages, upregulation of collagen synthesis, and promotion of tissue regeneration. Moreover, platelet-derived growth factor (PDGF) was shown to promote wound healing, angiogenesis, and tissue remodeling. conditions: Atrophic Acne Scar studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 75 type: ESTIMATED name: Pentoxifylline name: platelet rich plasma name: combined pentoxifylline and platelet rich plasma measure: goodman and baron qualitative grading system of postacne scarring sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag university Hospital status: RECRUITING city: Sohag country: Egypt name: Magdy M Amin, professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06319755 id: X23-0230 briefTitle: Characteristics of Intestinal Microbiome Following Pancreatic Surgery overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-08 date: 2025-02 date: 2024-03-20 date: 2024-03-20 name: Royal Prince Alfred Hospital, Sydney, Australia class: OTHER briefSummary: The goal of this observational study is to learn about intestinal microbiome structure and function in individuals who have undergone a pancreatoduodenectomy and compare to healthy matched controls.

The primary objectives of the study are:

1. To explore and describe any differences in the gut microbiota especially Shannon diversity index
2. To conduct functional profiling by exploring and describing any differences in functional metabolites produced in the gut in people having had pancreatoduodenectomy greater than 6 months ago compared to healthy matched controls.

Participants will be asked to complete the following:

* Three-day food, bowel and medication diary (see Protocol appendix 5)
* Gastrointestinal Symptom Rating Scale (see Protocol appendix 6)
* Quality of life questionnaire (see Protocol appendix 7)
* Stool sample test using Microba Insight TradeMark (a small swab is taken from soiled toilet paper, sealed in a room-temperature storage capsule and mailed to the testing laboratory) conditions: Pancreatic Cancer conditions: Microbiota conditions: Pancreatoduodenectomy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 20 type: ESTIMATED measure: Comparison of microbiota profile between post-surgical participants and healthy controls. measure: Compliance with 3-day food dairies measure: Pre-paid return rates measure: Ease of matching measure: Shannon diversity index measure: Gastrointestinal symptoms measure: Protein:fibre ratio of diet sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06319742 id: NSISTRCR_2201 briefTitle: Extracellular Vesicle Surface Markers In Acute Cerebrovascular Syndromes. acronym: ElViS-ACS overallStatus: RECRUITING date: 2022-11-18 date: 2025-12-31 date: 2026-01-31 date: 2024-03-20 date: 2024-04-18 name: Ospedale Civico, Lugano class: OTHER_GOV briefSummary: Clinical implication of eventual blood biomarkers for stroke diagnosis and prognosis would be limited, mainly because clinical evaluation and scales (providing stroke severity) or neuroimaging (providing accurate size of the lesion) are more reliable predictors for clinical outcome prediction. In clinical practice, it would be more useful to find a biomarker, which can help to orientate the physician in conditions in which the clinical picture and imaging provide a limited support.

Transient Ischemic Attacks (TIAs) represent a classical example for which a biomarker would be of interest to confirm and distinguish a brain ischemic process from a stroke mimic. Diagnostic biomarkers of TIA have been investigated, but none of the potential candidates reached enough accuracy for TIA diagnosis. Our group has found that Extracellular Vesicles (EVs) could be useful as biomarkers for detecting brain ischemia in patients with TIA because the EV-surface antigen profile appears to be different in patients with transient symptoms, adjudicated to be very likely caused by brain ischemia, compared to patients whose symptoms were less likely to due to brain ischemia. Our study has raised interest in the scientific community recognizing the promising role of of blood-derived EVs analysis in expanding the possibilities to correctly diagnose and classify TIA and stroke events, discriminate them from TIA or stroke mimics, with important future implications in management and therapy of the patients with acute ischemic cerebrovascular syndrome. the validity of our approach needs to be tested in a larger, prospective, multicenter study. conditions: Stroke, TIA, Stroke-mimics, Stroke Biomarkers studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Extracellular vescicles (EV) analysis measure: TIA differentiation from TIA mimics measure: TIA differentiation from Stroke measure: Stroke etiology sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Neurocenter of Southern Switzerland, Ospedale Civico status: RECRUITING city: Lugano state: Ticino zip: CH-6900 country: Switzerland name: Carlo Cereda, MD role: CONTACT phone: +41 91 811 6691 email: carlo.cereda@eoc.ch name: Carlo Cereda role: PRINCIPAL_INVESTIGATOR name: Giovanni Bianco role: SUB_INVESTIGATOR name: Lucio Barile role: SUB_INVESTIGATOR lat: 46.01008 lon: 8.96004 hasResults: False

 nctId: NCT06319729 id: REC/22-23/0659 briefTitle: A Chinese Herbal Medicine for IBS-C acronym: CDD2105RCT1 overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-08-31 date: 2024-11-30 date: 2024-03-20 date: 2024-03-21 name: Hong Kong Baptist University class: OTHER briefSummary: This double-blind, placebo-controlled randomized pilot clinical trial will test the hypothesis that granules of CDD-2105, a Chinese herbal medicine formula, will have efficacy in alleviating constipation and abdominal pain in individuals with IBS-C. Participants (n=78) will be randomly assigned to the treatment or placebo group in a 1:1 ratio, followed by 4 weeks of intervention and 4 weeks of follow-up. conditions: Constipation-predominant Irritable Bowel Syndrome studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A double-blind, placebo-controlled randomized clinical trial primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: All the study drugs and placebo should be in the same package with the same drug appearance and blinded according to the randomized numbers of the subgroups. The specific blinding method is set as follows: the study drugs and placebo are uniformly packaged and numbered according to the corresponding randomized group results. One copy of the blinding letter in duplicate is sent with the test drug to the project leader of the test center for storage, and the other copy is kept by the pharmacy until the end of the trial. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: CDD-2105 name: Placebo measure: Abdominal Pain Responder Rate measure: Complete Spontaneous Bowel Movement (CSBM) Responder Rate measure: Change in the weekly average self-assessed daily maximum abdominal pain scores (0-10) measure: Change in the number of days of abdominal pain per week measure: Change in the average weekly Complete Spontaneous Bowel Movement (CSBM) frequency measure: Change in the average weekly Spontaneous Bowel Movement (SBM) frequency measure: Change in the score of Irritable Bowel Syndrome-Severity of Symptoms (IBS-SSS) questionnaire measure: Change in the score of Patient Assessment of Constipation-Symptoms (PAC-SYM) measure: Change in the score of Patient Assessment of Constipation Quality of Life (PAC-QoL) questionnaire measure: Safety: number of adverse events measure: Safety: the level of liver function (ALT, AST, AKP, GGT, TBIL, DBIL) and renal function (blood urea nitrogen, creatinine) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06319716 id: 23-01274 briefTitle: Leveraging Videos and Community Health Workers to Address Social Determinants of Health in Immigrants acronym: LINK-IT overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-12-31 date: 2028-06-30 date: 2024-03-20 date: 2024-04-05 name: NYU Langone Health class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The overall goal of this study is to examine the efficacy of the video-based Diabetes Self-Management Education and Support (DSMES) (hereafter VIDEO), or the video-based DSMES+community health worker (CHW) intervention (hereafter VIDEO+CHW), compared with a wait-list control group (hereafter CONTROL) to improve glycemic control among Chinese immigrants with uncontrolled Type 2 diabetes in NYC. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 324 type: ESTIMATED name: Video-Based Diabetes Self-Management Education and Support (DSMES) name: Community Health Worker (CHW) Support measure: Hemoglobin A1c (HbA1c) Levels measure: Hemoglobin A1c (HbA1c) Levels measure: Hemoglobin A1c (HbA1c) Levels measure: Stanford Self-Efficacy for Diabetes Scale Score measure: Stanford Self-Efficacy for Diabetes Scale Score measure: Stanford Self-Efficacy for Diabetes Scale Score measure: Summary of Diabetes Self-Care Activities (SDSCA) Score measure: Summary of Diabetes Self-Care Activities (SDSCA) Score measure: Summary of Diabetes Self-Care Activities (SDSCA) Score measure: Starting the Conversation (STC) Diet Scale Score measure: Starting the Conversation (STC) Diet Scale Score measure: Starting the Conversation (STC) Diet Scale Score measure: International Physical Activity Questionnaire (IPAQ) Short-Version Score measure: International Physical Activity Questionnaire (IPAQ) Short-Version Score measure: International Physical Activity Questionnaire (IPAQ) Short-Version Score sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06319703 id: 22-00634 briefTitle: Implementing an Effective Diabetes Intervention Among Low-Income Immigrants acronym: IDEAL overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-10-31 date: 2028-03-31 date: 2024-03-20 date: 2024-03-20 name: NYU Langone Health class: OTHER name: Agency for Healthcare Research and Quality (AHRQ) briefSummary: The goal of this IDEAL project is to examine the effectiveness and implementation process of the video-based Diabetes Self-Management Education and Support (DSMES) + community health worker (CHW) (hereafter: "IDEAL") intervention compared with a wait-list control group (hereafter: "CONTROL") to improve glycemic control among Chinese immigrants with Type 2 diabetes (T2D) in New York City (NYC). Participants will be randomized with equal allocation to one of the 2 groups. The IDEAL group will receive 1 DSMES brief video/week for 24 weeks delivered via text message. The CHW will assess participants' SDOH barriers to T2D care and link them to available resources in the community. The CONTROL group will continue to receive their usual care and at the end of the study, they will receive DSMES videos. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 270 type: ESTIMATED name: Diabetes Self-Management Education and Support (DSMES) Videos name: Community Health Worker Support (CHW) measure: Change in Hemoglobin A1C (HbA1c) Test Scores measure: Change in Hemoglobin A1C (HbA1c) Test Scores measure: Stanford Self-Efficacy for Diabetes Scale Score measure: Stanford Self-Efficacy for Diabetes Scale Score measure: Stanford Self-Efficacy for Diabetes Scale Score measure: Summary of Diabetes Self-Care Activities (SDSCA) Score measure: Summary of Diabetes Self-Care Activities (SDSCA) Score measure: Summary of Diabetes Self-Care Activities (SDSCA) Score measure: Starting the Conversation (STC) Diet Scale Score measure: Starting the Conversation (STC) Diet Scale Score measure: Starting the Conversation (STC) Diet Scale Score measure: National Cancer Institute Dietary Screener Questionnaire Score measure: National Cancer Institute Dietary Screener Questionnaire Score measure: National Cancer Institute Dietary Screener Questionnaire Score measure: International Physical Activity Questionnaire (IPAQ) Short-Version Score measure: International Physical Activity Questionnaire (IPAQ) Short-Version Score measure: International Physical Activity Questionnaire (IPAQ) Short-Version Score sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06319690 id: REC/RCR&AHS/23/0362 briefTitle: Combined Effects of Lion's Breath Technique With Chest Percussion Therapy in Pneumonia Patients overallStatus: RECRUITING date: 2024-03-01 date: 2024-06-05 date: 2024-06-15 date: 2024-03-20 date: 2024-03-20 name: Riphah International University class: OTHER briefSummary: This study will be randomized controlled trial with non-probability convenient sampling. Sample size will be 90,45 in each group. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure. conditions: Pneumonia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Control Trial (RCT) primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Lion's Breath Technique name: Chest Percussion Therapy measure: George respiratory questionnaire measure: Forced vital capacity (FVC) measure: Borg Dyspnea Scale measure: Forced expiratory volume (FEV1) measure: FEV1/FVC Ratio sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jinnah Hospital status: RECRUITING city: Lahore state: Punjab zip: 42000 country: Pakistan name: Muhammad Ashraf Jamal, MBBS role: CONTACT phone: 03009685981 email: drmajamal@hotmail.com name: Tania Amjad, DPT role: SUB_INVESTIGATOR lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06319677 id: Ivljingjing briefTitle: PK/PD Study of Anti-Infective Drugs in Critically Ill Patients Receiving Extracorporeal Membrane Oxygenation Treatment acronym: ECMO overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2027-05-01 date: 2024-03-20 date: 2024-03-20 name: The Third Xiangya Hospital of Central South University class: OTHER briefSummary: Extracorporeal membrane pulmonary oxygenation (ECMO) may provide partial or complete support for organ replacement in patients with severe cardiopulmonary failure, buying time for further management of the primary disease. However, ECMO may significantly alter the pharmacokinetic and pharmacodynamic profiles of critically ill patients, affecting the safety and efficacy of drug therapy. This prospective observational study aims to investigate the impact of ECMO treatment on the pharmacokinetics and pharmacodynamics of antimicrobial drugs in critically ill adult patients. Investigators intend to establish a Population Pharmacokinetic (POP PK) and Pharmacokinetic/Pharmacodynamic (PK/PD) model by prospectively collecting blood samples from patients and relevant treatment data. The primary objective is to quantitatively characterize the pharmacokinetic profiles of critically ill patients undergoing ECMO support and provide model-based recommendations for drug regimens tailored to critically ill patients. conditions: Critical Illness conditions: Extracorporeal Membrane Oxygenation Complication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: ECMO treatment measure: Blood drug concentration measure: Pharmacokinetic parameter measure: Pharmacokinetic parameter measure: Mortality at 14 and 28 days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xiangya Third Hospital, Central South University city: Changsha state: Hunan country: China name: Jingjing Liu, Doctor role: CONTACT phone: +86 0731-88618170 email: ivljingjing@126.com lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06319664 id: sjnkzzj briefTitle: Clinical Outcomes and Decision-making Choice of Skull Base Approaches for Petroclival Meningiomas overallStatus: COMPLETED date: 2021-05-27 date: 2021-08-10 date: 2021-09-10 date: 2024-03-20 date: 2024-03-20 name: Xiangya Hospital of Central South University class: OTHER briefSummary: Petroclival meningioma (PCM) is a technically challenging lesion. We aimed to analyze the role of various skull base approaches and evaluate the therapeutic outcomes guided by the modified classification. We retrospectively analyzed the clinical characteristics, surgical approaches, outcomes and follow-up data from 179 cases of PCM from January 2011 to December 2020. We modified the previous classification into updated five types with two subtypes: clivus type (CV), petroclival type (PC), petroclivosphenoidal type (PC-S), sphenopetroclival type (S-PC) with two subtypes of S-PC I and S-PC II and central skull base type (CSB). Statistical analysis was performed using IBM SPSS Statistical Package 21.0. The t-test was performed to clinical data comparisons between the two groups and the ANOVA test was used to compare the difference between multiple groups. P \< 0.05 was considered statistically significant. conditions: Skull Base Meningioma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 179 type: ACTUAL name: retrosigmoid approach (RSA) name: subtemporal transtentorial transpetrosal approach (STTA) name: extended pterional transtentorial approach (EPTA) name: pretemporal trancavernous anterior transpetrosal approach (PTCA) name: presigmoid combined supra-infratentorial approach (PCA) name: inoperable measure: QOL were assessed and measured using the Karnofsky Performance Scale (KPS) score sex: ALL minimumAge: 15 Years maximumAge: 73 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Xiangya Hospital, Central South University city: Changsha state: Hunan zip: 410000 country: China lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06319651 id: REC/RCR&AHS/23/0360 briefTitle: Effects of Lower Limb Resistance Band Exercises in Phase 1 Cardiac Rehabilitation overallStatus: RECRUITING date: 2024-03-01 date: 2024-06-05 date: 2024-06-15 date: 2024-03-20 date: 2024-03-27 name: Riphah International University class: OTHER briefSummary: This study will be randomized controlled trial with non-probability purposive sampling. Study conducted among post CABG patients. Sample size will be 56, 28 in each group. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure. conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial (RCT). Pre \& Post data collection primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 56 type: ESTIMATED name: Lower Limb Resistance Band Exercises name: Routine Phase 1 cardiac rehabilitation measure: Functional Independence Measure measure: 6 Minute Walk Test measure: Forced expiratory volume (FEV1) measure: Forced vital capacity (FVC) measure: FEV1/FVC ratio sex: ALL minimumAge: 35 Years maximumAge: 60 Years stdAges: ADULT facility: Rehmatul lil Alameen Institute of cardiology status: RECRUITING city: Lahore state: Punjab zip: 42000 country: Pakistan name: Dr. Fareed Ahmad, MBBS role: CONTACT phone: 04299330101 email: ms.raic@pessi.punjab.gov.pk name: Afifa Shoaib, DPT role: SUB_INVESTIGATOR lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06319638 id: SGB TBI briefTitle: Efficacy of Stellate Ganglion Block in Traumatic Brain Injury Patients overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2024-12 date: 2024-03-20 date: 2024-03-20 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are:

Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.

Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Rehabilitation therapy name: Stellate ganglion block name: Placebo block name: Lidocaine Hydrochloride measure: Penetration-Aspiration Scale measure: Modified Barthel Index measure: Swallowing duration measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06319625 id: SGB PARKINSON briefTitle: Effectiveness of Stellate Ganglion Block in Patients Diagnosed With Parkinson's Disease overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-20 date: 2024-03-20 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:

• Can stellate ganglion block improve the dysphagia and activities of daily living in patients with Parkinson's disease.

Participants will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation therapy name: Stellate ganglion block name: Lidocaine hydrochloride name: Placebo injection measure: Penetration-Aspiration Scale measure: Modified Barthel Index measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06319612 id: SGB OSA DOUBLE BLIND briefTitle: Effectiveness of Stellate Ganglion Block for the Treatment of Obstructive Sleep Apnea overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-20 date: 2024-03-20 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to test the efficacy of stellate ganglion block in Obstructive Sleep Apnea. The main question it aims to answer are:

• Can stellate ganglion block improve Obstructive Sleep Apnea? Patients were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study. conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: routine rehabilitation treatment name: Stellate ganglion block name: Lidocaine Hydrochloride name: Placebo injection measure: Epworth Sleepiness Scale measure: Apnea-Hypopnea Index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06319599 id: SGB GUDU briefTitle: Stellate Ganglion Block in Children With Autistic Disorder overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-20 date: 2024-03-20 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:

Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated. conditions: Autistic Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Routine therapy name: Stellate ganglion block name: Lidocaine hydrochloride name: placebo injection measure: Childhood Autism Rating Scale measure: Children's Communication Checklist measure: Social Interaction Assessment Scale measure: Children's Depression Inventory measure: Childhood Anxiety Sensitivity Index sex: ALL minimumAge: 4 Months maximumAge: 8 Years stdAges: CHILD hasResults: False

 nctId: NCT06319586 id: Soh-Med-24-02-08MS briefTitle: The Radial Forearm Flap In Reconstruction Of Upper Limb Injuries overallStatus: COMPLETED date: 2024-02-07 date: 2024-02-07 date: 2024-02-07 date: 2024-03-20 date: 2024-03-20 name: Sohag University class: OTHER briefSummary: The radial forearm flap is a very useful and versatile flap with a long vascular pedicle and a thin, pliable skin. It's used in reconstruction of the mutilated hand as a reverse pedicled flap. The dominant pedicle is the radial artery, with venous outflow through the dual system of the venae comitantes and cephalic vein. Sensory innervation may be derived from the medial and lateral antebrachial cutaneous nerves. The radial forearm flap offers the advantage of a large area of donor tissue from the involved extremity with the potential for inclusion of bone, nerve, and tendon grafts. Sacrifice of the radial artery has not been associated with significant patient symptoms However, the donor defect can be troublesome, frequently requiring skin grafting directly over the paratenon of the flexor tendons, producing an undesirable donor site appearance conditions: for Upper Limb Soft Tissue Coverage studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ACTUAL name: Radial Forearm Flap measure: Viability of the flap sex: ALL minimumAge: 5 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag University hospitals city: Sohag country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06319573 id: 2305-UNIVF-070-DC briefTitle: The Impact of Personalized Prognostic Counseling on IVF Patient's Experience and Treatment Utilization overallStatus: RECRUITING date: 2024-03-19 date: 2025-08-31 date: 2026-02-28 date: 2024-03-20 date: 2024-04-19 name: Ginefiv class: OTHER name: Univfy Inc. briefSummary: This study will be conducted in two phases. In the first phase, research subjects will be assigned to receive standard counseling. In the second phase, research subjects will receive Univfy counseling. conditions: Infertility studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 366 type: ESTIMATED name: Counseling Supported by Univfy® Report name: Standard Counseling measure: Treatment utilization (conversion) rate in the two groups measure: Patient experience responses measure: Validation of Univfy prediction upon CLBdR measure: Retention Rate measure: Time to Pregnancy measure: Self-reported satisfaction related to psychological support and cost of treatment sex: FEMALE minimumAge: 18 Years maximumAge: 39 Years stdAges: ADULT facility: Ginefiv S.L status: RECRUITING city: Barcelona zip: 08015 country: Spain name: Xinxin Lin Miao role: CONTACT phone: +34930400200 email: x.lin@ginefiv.com name: Xinxin Lin Miao, MD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Ginefiv S.L status: RECRUITING city: Madrid zip: 28018 country: Spain name: Joaquin Llacer role: CONTACT phone: +34900908988 email: j.llacer@ginefiv.com name: Joaquin Llacer, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06319560 id: JEP-2023-866 briefTitle: Hydroxychloroquine in Type 2 Diabetes During Pregnancy overallStatus: RECRUITING date: 2024-01-02 date: 2026-01-01 date: 2027-01-01 date: 2024-03-20 date: 2024-04-19 name: National University of Malaysia class: OTHER briefSummary: The goal of this clinical trial is to compare the use of hydroxychloroquine as an adjunct to the current treatment of pregnant women with Type 2 diabetes mellitus.

The main questions it aims to answer are:

* Does hydroxychloroquine improve the pregnancy outcomes in women with type 2 diabetes during pregnancy?
* Does hydroxychloroquine improve the inflammatory markers in women with type 2 diabetes during pregnancy? Participants will be randomised into the intervention and control group. The control group will be on standard treatment where as the intervention group will receive hydroxychloroquine as an adjunct of standard treatment conditions: Diabetes in Pregnancy conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: Hydroxychloroquine Oral Tablet measure: To compare the serum glycated haemoglobin between the two groups measure: To compare the serum fructosamine between the two groups measure: To compare the serum interleukin-6 between the two groups measure: To compare the serum interleukin-10 between the two groups measure: To compare the serum tumour necrosis factor alpha between the two groups measure: To compare the shearwave elastography of the placenta between the two groups measure: To compare the gestational age at delivery between the two groups measure: Type of labour measure: Mode of delivery measure: Postpartum haemorrhage measure: Third or fourth degree perineal tear measure: Neonatal birth weight at delivery measure: Large for gestational age or macrosomia measure: Shoulder dystocia measure: Appearance, pulse, grimace, activity and respiration score of neonate at 5 minutes measure: Arterial cord pH at birth measure: Number of neonates needing admission into neonatal intensive care unit measure: Height or length of neonates measure: Weight of the neonates measure: Hospital admission sex: FEMALE minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT facility: Antenatal clinic, UKM Medical Centre status: RECRUITING city: Cheras state: Kuala Lumpur zip: 56000 country: Malaysia name: Rahana Abd Rahman role: CONTACT lat: 3.05 lon: 101.76667 hasResults: False

 nctId: NCT06319547 id: Soh-Med-24-02-07MS briefTitle: Comparing Outcome of Thoracocentesis and Pigtail Catheter Drainage in Treatment of Patients With Hepatic Hydrothorax overallStatus: RECRUITING date: 2024-02-20 date: 2025-02 date: 2025-03 date: 2024-03-20 date: 2024-03-20 name: Sohag University class: OTHER briefSummary: Hepatic hydrothorax (HH) is a pleural effusion that develops in a patient with cirrhosis and portal hypertension in the absence of cardiopulmonary disease (Lv et al., 2018). Several factors are known to contribute to the development of effusion; the most accepted mechanism of which is the direct delivery of ascitic fluid from the peritoneal cavity to the pleural cavity by "positive" intra-abdominal pressure and a "negative" intrathoracic pressure of the pleural cavity through microscopic congenital diaphragmatic defects (Han et al., 2022). conditions: Hepatic Hydrothorax studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Thoracocentasis measure: percentage of empyema in patients with hepatic hydrothorax after thoracocentesis sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag University hospitals status: RECRUITING city: Sohag country: Egypt name: Magdy M Amin, Professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06319534 id: SGB-ZHENQIU briefTitle: Stellate Ganglion Block in Bulbar Palsy overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-20 date: 2024-03-20 name: Copka Sonpashan class: OTHER_GOV briefSummary: This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in 3 hospitals in China. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, Functional Oral Intake Scale, Flexible laryngoscope are used to assess swallowing function. conditions: Bulbar Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Comprehensive rehabilitation name: Stellate ganglion block name: Lidocaine Hydrochloride name: placebo injection measure: Penetration-Aspiration Scale measure: Functional Oral Intake Scale measure: Murray secretion severity scale measure: Yale pharyngeal residue severity rating scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06319521 id: SGB-REFLUX briefTitle: Stellate Ganglion Block on Gastroesophageal Reflux Disease overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-20 date: 2024-03-20 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore Clinical Effect of Stellate Ganglion Block on Gastroesophageal Reflux Disease. The main question it aims to answer is:

• Can stellate ganglion block improve gastroesophageal reflux symptoms better on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Stellate Ganglion Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, Self-Evaluation Questionnaire for Gastroesophageal Reflux Disease, to see if the Stellate Ganglion Block can help improve the symptom. conditions: Gastroesophageal Reflux Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation therapy name: Stellate ganglion block name: Lidocaine hydrochloride name: Placebo injection measure: Gastroesophageal Reflux Disease Questionnaire measure: Pressure pain threshold measure: Modified Mayo Clinic Dysphagia-30 questionnaire sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06319508 id: SGB-NT briefTitle: Stellate Ganglion Block in Cerebral Palsy overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-20 date: 2024-03-20 name: Copka Sonpashan class: OTHER_GOV briefSummary: The goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. The main question it aims to answer are:

• Can stellate ganglion block improve the dysphagia of children with cerebral palsy? Participants were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: routine rehabilitation treatment name: Stellate ganglion block name: Lidocaine hydrochloride name: Placebo injection measure: Penetration-Aspiration Scale measure: Swallowing duration measure: Functional Oral Intake Scale sex: ALL minimumAge: 4 Years maximumAge: 7 Years stdAges: CHILD hasResults: False

 nctId: NCT06319495 id: SGB-CSVD briefTitle: Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-20 date: 2024-03-20 name: Copka Sonpashan class: OTHER_GOV briefSummary: This is a prospective study conducted on patients with Cerebral Small Vessel Disease, dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given Stellate Ganglion Block. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index. conditions: Cerebral Small Vessel Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation therapy name: Stellate ganglion block name: Lidocaine Hydrochloride name: placebo injection measure: Penetration-Aspiration Scale measure: Modified Barthel Index measure: Mini-Mental State Examination measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06319482 id: Adherence Study briefTitle: The Adherence of Proactive Sleep Apnea Therapy overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-08-01 date: 2025-08-01 date: 2024-03-20 date: 2024-03-20 name: NovaResp Technologies Inc class: INDUSTRY briefSummary: The goal of this clinical trial is to compare the adherence to Positive Airway Pressure (PAP) therapy for newly diagnosed Obstructive Sleep Apnea (OSA) patients. The main question(s) it aims to answer are:

1. To compare the adherence of proactive therapy and conventional Automatic-PAP (APAP) therapy short-term (3 months) and long-term (12 months) for newly diagnosed OSA patients.
2. To compare health outcomes (AHI, nightly pressure, and patient-reported outcomes) between proactive therapy and conventional APAP therapy. conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 200 type: ESTIMATED name: Proactive CPAP Therapy name: Conventional APAP Therapy measure: Adherence measure: Apnea-Hypopnea Index measure: Pressure measure: Self-assessed sleep outcomes measure: Self-assessed functional outcomes sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06319469 id: FMBSUREC/06122022/Mohamed briefTitle: The Additive Value of Pyridostigmine to Silodosin in Acute Urinary Retention overallStatus: COMPLETED date: 2023-02-01 date: 2024-01-30 date: 2024-01-30 date: 2024-03-20 date: 2024-03-20 name: Beni-Suef University class: OTHER briefSummary: Acute urine retention, AUR, is often considered the most serious consequence of aging men with progressive benign prostatic hyperplasia (BPH). AUR is defined as the sudden and painful inability to void freely. This study aims to evaluate whether pyridostigmine bromide added to silodosin is beneficial in treating acute urine retention caused by BPH. conditions: Prostatic Hyperplasia studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 140 type: ACTUAL name: silodosin 8 mg capsule and the pyridostigmine bromide 60 mg tablet name: silodosin 8 mg capsule measure: International Prostate Symptom Score (IPSS) sex: MALE minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beni-Seuf University Hospital city: Banī Suwayf country: Egypt lat: 29.07441 lon: 31.09785 hasResults: False

 nctId: NCT06319456 id: APG2575CC301 briefTitle: A Global Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL. overallStatus: RECRUITING date: 2024-04 date: 2027-08 date: 2028-08 date: 2024-03-20 date: 2024-04-16 name: Ascentage Pharma Group Inc. class: INDUSTRY briefSummary: This is a global, multicenter, randomized, open-label, Phase III confirmatory study to investigate the efficacy and safety of Lisaftoclax (APG-2575) in combination with Acalabrutinib in patients with newly diagnosed CLL/SLL. conditions: CLL/SLL studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 344 type: ESTIMATED name: Lisaftoclax (APG-2575) name: Acalabrutinib name: Fludarabine name: Cyclophosphamide，CTX name: Rituximab name: Chlorambucil measure: Progress Free Survival (PFS) measure: Objective Response Rate (ORR) measure: Minimal Residual Disease (MRD) negativity rate measure: Safety evaluation based on the adverse event concurrence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Bengbu Medical College status: NOT_YET_RECRUITING city: Bengbu state: Anhui zip: 233004 country: China name: Yinghua Geng, Ph.D. role: CONTACT name: Yinghua Geng, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 32.94083 lon: 117.36083 facility: Guangdong Provincial People's Hospital status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510080 country: China name: Wenyu Li, Ph.D. role: CONTACT name: Wenyu Li, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Nanfang Hospital of Southern Medical University status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510515 country: China name: Xutao Guo, Ph.D. role: CONTACT name: Xutao Guo, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Henan Provincial Cancer Hospital status: RECRUITING city: Zhengzhou state: Henan zip: 450003 country: China name: Keshu Zhou, M.D., Ph.D. role: CONTACT phone: 13674902391 email: drzhouks77@163.com name: Keshu Zhou, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 34.75778 lon: 113.64861 facility: Hematology Hospital of the Chinese Academy of Medical Sciences status: RECRUITING city: Tianjin state: Tianjin zip: 300020 country: China name: Lugui Qiu, M.D., Ph.D. role: CONTACT phone: 022-23909272 email: qiulg@ihcams.ac.cn name: Lugui Qiu, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06319443 id: STUDY00019235 briefTitle: Daily Vinegar Ingestion and 24-Hour Blood Glucose Control overallStatus: RECRUITING date: 2024-03 date: 2024-06 date: 2025-04 date: 2024-03-20 date: 2024-03-20 name: Arizona State University class: OTHER briefSummary: When linking dietary interventions and blood glucose management, much of the existing research - particularly studies exploring the effects of vinegar - has relied on discrete readings from the conventional testing methods: blood samples or glucometers. These methods lack the capacity to provide insights into blood glucose dynamics 24/7.

Recognizing this gap, the current study aims to utilize continuous glucose monitoring to examine the impact of daily vinegar ingestion on glucose variability in adults identified as glucose intolerant. conditions: Glucose Intolerance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This is a 9-day trial. Participants will be fitted with a continuous glucose monitor and follow their typical diet and activity patterns. Participants will be randomized to ingest 2 tablespoons of vinegar twice daily (diluted in water) or a vinegar pill for the first 4 days on the trial. On day 5 of the trial participants will consume the alternate treatment for trial days 5-8. Dietary intake will be recorded daily using a fitness app. Physical activity will be assessed at baseline and on study day 4 and 8. On day 9, participants will return to the test site for device removal. primaryPurpose: OTHER masking: SINGLE maskingDescription: Liquid and pill vinegar will be the treatments. The pill is the 'control' as the level of acetic acid is below the amount needed for an antiglycemic effect (a fact not realized by the participant). whoMasked: PARTICIPANT count: 12 type: ESTIMATED name: Liquid vinegar name: vinegar pill measure: Average glucose measure: Glucose: time in range sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 850 PBC status: RECRUITING city: Phoenix state: Arizona zip: 85004 country: United States name: Carol S Johnston, PhD role: CONTACT phone: 602-965-2539 email: carol.johnston@asu.edu lat: 33.44838 lon: -112.07404 hasResults: False

 nctId: NCT06319430 id: HS26236(H2023:343) briefTitle: Technology in Play for Children With Physical Disabilities: the Dice Model of Play overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-30 date: 2025-05-28 date: 2024-03-20 date: 2024-03-20 name: University of Manitoba class: OTHER name: Rehabilitation Centre for Children, Canada briefSummary: Play is an important activity for children. Almost all children play, but what is play? It is not easy to define play. In the past, people believed that children played to burn their energy. Now, it is known that play is important for children's growth. Some kids with disabilities cannot play. Many experts use play to teach children specific skills. People often forget that play is a child's right. It is important to help all children play. The first step is to define play and find what features are important in helping a child with a disability play.

There are some models of play. But they are not complete. They do not look at play as a whole. Some models are just about playfulness, and some are about playing with others. Having a model that defines play helps researchers and clinicians think about play and the different parts of it. Then, when a child cannot play, experts can fix the part that is not working. Investigators want to introduce a model of play in this project. Investigators want to edit and complete it in three steps. First, Investigators will ask parents and children with disabilities about things that help or do not help them play; then, investigators will give Lego robots to kids that they will build with help and play with them for a few weeks. And at the end, investigators will ask therapists and other experts about our model of play. This model will be edited during the study. conditions: Physical Disability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The primary purpose is validation of.......... primaryPurpose: OTHER masking: NONE count: 10 type: ESTIMATED name: robots name: conventional measure: Test of Playfulness measure: The Child Initiated Pretend Play Assessment (ChIPPA-2) measure: The Pretend Play Enjoyment-Developmental Checklist (PPE-DC) sex: ALL minimumAge: 3 Years maximumAge: 8 Years stdAges: CHILD typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2024-01-22 uploadDate: 2024-03-04T16:47 filename: Prot_SAP_ICF_000.pdf size: 1962440 hasResults: False

 nctId: NCT06319417 id: HT-UCAM briefTitle: Hydroxytyrosol Caramel Treatment on Cardiovascular Risk Patients overallStatus: COMPLETED date: 2022-04-15 date: 2023-03-23 date: 2023-03-23 date: 2024-03-20 date: 2024-03-20 name: Universidad Católica San Antonio de Murcia class: OTHER briefSummary: The goal of this double-blind crossover randomized clinical trial is to evaluate the impact of a phenolic natural compound called hydroxytyrosol (HT) on patients at cardiovascular risk (CVR). The main questions it aims to answer are:

* Evaluating the effect of HT caramels on CVR biomarkers.
* Assessing the impact of HT caramels on cellular phenotype.

Participants will take 4 caramels/day, each containing 15 mg of HT, consuming a daily intake of 60 mg for 28 days. One group will begin with HT caramel consumption for 28 days, while the other group will start with a placebo treatment. Following a 2-week washout period, the treatments will be switched between the groups. Those who initially consumed HT will then switch to the placebo treatment, and vice-versa, each for a duration of 28 days. conditions: Cardiovascular Pathology studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: 28 days of treatment: one group with HT treatment and the other with placebo treatment.

2-weeks washout period. The treatment will be switched between groups for another 28 days: those who initially consumed HT will the switch to the placebo treatment, and vice versa. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Nor participant and care provider knew the treatment given. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 26 type: ACTUAL name: HT treatment name: Placebo treatment measure: Change of cardiovascular biomarkers measure: Change of cellular phenotype of platelets sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Catholic University of Murcia (UCAM) city: Murcia zip: 30107 country: Spain lat: 37.98704 lon: -1.13004 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-03-01 uploadDate: 2024-03-12T10:59 filename: ICF_000.pdf size: 995478 hasResults: False

 nctId: NCT06319404 id: 2022YFC2505700 briefTitle: Immune Function of Colorectal Cancer Lymph Nodes overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-04-01 date: 2024-03-20 date: 2024-03-20 name: Shanxi Province Cancer Hospital class: OTHER name: The Second Affiliated Hospital of Harbin Medical University name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences briefSummary: Lymph nodes are very important immune organs in the human body and play an important role in the physiological and pathological activities of the body, especially in anti-tumor immunity. The role of regional draining lymph nodes in the development of colorectal cancer is still unknown. In this study, the role of lymph nodes in the development of colorectal cancer was investigated through multicenter and multi-omics data. conditions: Colorectal Cancer conditions: Lymph Node studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: To investigate the difference of immune pathway activation in tumor-draining lymph node based on genomics measure: To investigate the relationship between the type and number of immune cells in tumor draining lymph nodes and the activation of immune pathways is based on pathomics measure: The immune function of tumor draining lymph nodes of colorectal cancer patients was previously identified based on radiomics sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06319391 id: JSZ007 briefTitle: Analysis of the Effect of Donor CYP3A5 Gene Polymorphism on Early Tacrolimus Concentration and Postoperative Acute Renal Injury After Liver Transplantation overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-01 date: 2024-05-01 date: 2025-10-01 date: 2024-03-20 date: 2024-03-20 name: Ziqiang Li class: OTHER briefSummary: Tacrolimus is the most commonly used immunosuppressant for preventing and treating rejection after liver transplantation. However, its treatment window is narrow, the pharmacokinetic individual differences are large, routine dose according to body weight, sometimes low dose will cause graft rejection of patients, or high dose will lead to infection and liver and kidney toxicity and other adverse reactions. Moreover, the conventional drug testing can not fully reflect the efficacy of tacrolimus, and there are shortcomings of lag, experience and passivity. FK506 is metabolized primarily by cytochrome P450 member 3A5 in the liver and intestines. CYP3A5\*3 is the most important factor determining the expression level of CYP3A5. This mutation can cause variable shear and produce unstable protein, so that patients carrying CYP3A5\*3/\*3 gene do not express CYP3A5. Acute kidney injury is a common and important complication after liver transplantation. Despite recent advances in organ preservation, surgical techniques, and immunosuppressive protocols, the incidence of AKI after orthotopic liver transplantation remains high. AKI has a significant impact on both short - and long-term prognosis of orthotopic liver transplantation recipients. Studies have shown that orthotopic liver transplantation recipients with AKI have significantly higher mortality rates in hospital, at 28 days and at 1 year after surgery than those without AKI. In this study, the relationship between donor and recipient CYP3A5 gene polymorphism and tacrolimus concentration was investigated, and the effect of donor and recipient CYP3A5 gene polymorphism and tacrolimus concentration on acute kidney injury after liver transplantation was investigated. To provide guidance for individual administration of gene-directed tacrolimus in patients, and provide basis for prevention and reduction of postoperative acute kidney injury in liver transplantation patients. conditions: Complete and Accurate Statistical Data of 60 Patients conditions: CYP3A5*3 Genotypes of 60 Donors and Recipients Were Analyzed Accurately conditions: Postoperative Tacrolimus Concentrations Were Accurately Recorded in 60 Patients conditions: According to the Diagnosis and Grading Criteria of Acute Kidney Injury, the Cases and Grading of Postoperative Acute Kidney Injury in 60 Patients Were Counted conditions: Scientific and Rigorous Statistical Analysis of Data studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 60 type: ESTIMATED name: CYP3A5*1*、CYP3A5*1*3 name: CYP3A5*3*3 measure: Fk506 measure: Scr sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital) city: Jinan state: Shandong zip: 250013 country: China lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06319378 id: CAPSI no 2 date 231024 id: 2023-505532-35-00 type: OTHER domain: CTIS briefTitle: Cancer Related Major Depression Treated With a Single Dose of Psilocybin acronym: CAPSI overallStatus: RECRUITING date: 2024-04-17 date: 2025-12 date: 2025-12 date: 2024-03-20 date: 2024-04-22 name: Section for Affective Disorders; Northern Stockholm Psychiatry class: OTHER name: Uppsala University Hospital name: Region Örebro County name: Vastra Gotaland Region name: Karolinska Institutet briefSummary: The goal of this randomized placebo controlled trial is to compare the antidepressant effect of a single oral dose of psilocybin 25 mg compared to 1 mg in 100 patients with cancer related major depressive disorder. The main question it aims to answer is:

The primary objective of this study is to evaluate the efficacy of a single 25 mg oral dose of psilocybin for major depressive disorder (MDD) compared to an active placebo (psilocybin 1 mg) assessed as the difference between groups in changes in depressive symptoms, in the following Population: 20-80 (inclusive) years old, current depressive episode (according to Patient Health Questionnaire (PHQ-9)

≥10), \>1 month after cancer diagnosis, with at least 12 months of life expectancy, willingness to abstain from other psychotherapeutic or antidepressant treatments during the study (wash out time 5 half-lives). conditions: MDD studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial, active placebo, randomization ratio 2:1 primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: psilocybin 25 mg sod name: psilocybin 1 mg sod measure: MADRS at day 42 measure: MADRS day 8 measure: MADRS-S at all evaluations between Day 0 and Day 42 (Mixed Models for Repeated Measures (MMRM) x1) measure: SDS at Day 42 measure: CGI at Day 8 and Day 42 (analysis of covariance (ANCOVA) x6) measure: EQ-5D-5L at Day 8 and Day 42 (ANCOVA x6) measure: AQOL-6D at Day 42 (ANCOVA x1) measure: MADRS at Day 90 and Day 180 (ANCOVA x2) measure: MADRS-S at all evaluations between Day 43 and Day 180 (MMRM x1) measure: SDS at Day 180 (ANCOVA x3) measure: GAD-7 at Day 180 (ANCOVA x3) measure: HADS at Day 180 (ANCOVA x3) measure: CGI at Day 90 and Day 180 (ANCOVA x6) measure: EQ-5D-5L at Day 90 and Day 180 (ANCOVA x6) measure: AQOL-6D at Day 90 and Day 180 (ANCOVA x2) measure: GAD-7 at Day 42 measure: HADS at Day 42 sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: region Västra Götaland status: RECRUITING city: Göteborg country: Sweden name: Helena Werin Sjögren, MD role: CONTACT email: helena.werin.sjogren@vgregion.se name: Mikael Landén, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 57.70716 lon: 11.96679 facility: Norra Stockholms Psykiatri status: RECRUITING city: Stockholm country: Sweden name: Evana Lopez, MD role: CONTACT email: evana.lopez@ki.se name: Carl-Johan Ekman, PhD role: PRINCIPAL_INVESTIGATOR lat: 59.33258 lon: 18.0649 facility: Psykiatriska Kliniken, Akademiska Sjukhuset status: RECRUITING city: Uppsala country: Sweden name: Evana Lopez role: CONTACT email: evana.lopez@ki.se name: robert Bodén, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 59.85882 lon: 17.63889 facility: Örebro sjukhus status: RECRUITING city: Örebro country: Sweden name: Axel Nordenskjöld, MD PhD role: CONTACT name: Evana Lopez, MD role: CONTACT email: evana.lopez@ki.se name: axel Nordenskjöld, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 59.27412 lon: 15.2066 hasResults: False

 nctId: NCT06319365 id: gurcansolmaz briefTitle: Yoga on Women's Blood Pressure, Sexual Life, And Marital Compliance overallStatus: RECRUITING date: 2023-03-01 date: 2024-03-22 date: 2024-03-22 date: 2024-03-20 date: 2024-03-25 name: University of Yalova class: OTHER briefSummary: Introduction This study will examine the effects of a 12-week yoga program consisting of one-hour sessions three times a week on blood pressure, sexual life and marital adjustment among hypertensive women. Hypertension can adversely affect vascular health and affect marital relationships by contributing to sexual dysfunction.

Method. The study will be a pre-post test randomized controlled study in accordance with CONSORT rules. Personal Information Form, Bloood pressure measurement, Arizona Sexual Experience Scale and Marital Adjustment Test will be used for data collection. conditions: Hypertension conditions: Sexuality studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 70 type: ESTIMATED name: yoga measure: blood presure sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yalova University status: RECRUITING city: Yalova country: Turkey name: GÜRCAN SOLMAZ role: CONTACT email: gurcansolmaz@hotmail.com lat: 40.65501 lon: 29.27693 hasResults: False

 nctId: NCT06319352 id: HUM00243293 briefTitle: Evaluation of Quality-of-Life Improvements Using UroShield Device overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2024-10 date: 2024-10 date: 2024-03-20 date: 2024-04-26 name: University of Michigan class: OTHER name: Nanovibronix briefSummary: The goal of this pilot study is to test key elements of the full study that will follow, including recruitment and retention strategies, intervention delivery, laboratory testing, data collection methods, and adherence to study protocol.

The main questions the investigators aim to answer focus on implementation and practicality:

* Recruitment feasibility and time to recruit
* How well do participants adhere to device protocol?
* How often do device components (i.e., actuators and drivers) have to be replaced?
* How much time is required for data collection and what sources or methods for data collection are used?

Results of this pilot study will inform the investigators as to necessary protocol modifications and overall feasibility for the larger randomized clinical trial to follow. conditions: Quality of Life conditions: Catheter-Associated Urinary Tract Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DEVICE_FEASIBILITY masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 16 type: ESTIMATED name: Active UroShield name: Sham UroShield measure: Recruitment rate measure: Device use adherence measure: Device accountability measure: Efficiency of data collection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06319339 id: 0419-23-FB briefTitle: Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-08 date: 2025-08 date: 2024-03-20 date: 2024-03-20 name: University of Nebraska class: OTHER briefSummary: Purpose: Peripheral artery disease (PAD) is associated with elevated oxidative stress, and oxidative stress has been implicated as the cause of reduced endothelial reactivity in individuals with PAD. Endothelial function is important because the endothelium contributes to the dilation of arteries during exercise, thereby implicating impaired endothelial function as a mechanism contributing to exacerbated exercise-induced ischemia. Therefore, the purpose of this study is to test the hypothesis that acute exogenous diroximel fumarate (Vumerity) intake will improve antioxidant capacity, thereby reducing oxidative stress and improving vascular function and walking capacity in those with PAD. Eligibility: Individuals with PAD will be deemed eligible for this study if they 1) are 50-75 years old and postmenopausal, 2) have a positive history of exercise-limiting claudication (Fontaine II or III), 3) do not have renal impairments, 4) do not have Fontaine stage IV PAD, and 5) are not currently pregnant or nursing. Age-matched controls will be deemed eligible for this study if they 1) are 50-75 years old and postmenopausal, 2) have an ABI greater than 0.9 (no PAD), 3) do not have exercise-limiting diseases or injuries, 4) do not have renal impairments, and 5) are not currently pregnant or nursing. Intervention and Evaluation: During this study, participants will be administered diroximel fumarate or a placebo, and the acute effects of diroximel fumarate on vascular function and walking capacity will be assessed. Vascular function and walking capacity will be assessed with flow-mediated dilation, arterial stiffness, head-up tilt test, blood biomarkers, near-infrared spectroscopy, and a treadmill test. Follow-up: There will be a follow-up visit to assess blood work after diroximel fumarate. conditions: Peripheral Artery Disease conditions: Peripheral Vascular Diseases conditions: Peripheral Arterial Disease conditions: Peripheral Arterial Occlusive Disease studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: There will be a peripheral artery disease (PAD) group and an age-matched healthy control group. Within each of these groups will be a 1:1 randomized, crossover, double-blinded study. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double-blinded study whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: Vumerity name: Placebo measure: Macrovascular Endothelial Function measure: Oxygen Transfer and Utilization measure: Femoral and Popliteal Artery Blood Flow measure: Walking capacity measure: Autonomic Nervous Activity measure: Arterial Stiffness measure: Circulating blood markers of Oxidative Stress and Antioxidants sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Nebraska - Omaha city: Omaha state: Nebraska zip: 68182 country: United States name: Song-Young Park, PhD role: CONTACT phone: 402-554-3374 email: song-youngpark@unomaha.edu lat: 41.25626 lon: -95.94043 hasResults: False

 nctId: NCT06319326 id: Postfeed Intestinal Perfusion briefTitle: Intestinal Perfusion After Feeding in Preterm and Term Infants overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2024-06-30 date: 2024-08-31 date: 2024-03-20 date: 2024-03-20 name: The Hospital for Sick Children class: OTHER name: Xiamen Children's Hospital briefSummary: This is a pilot exploratory observational prospective cohort phase I study. In this study, we will gather preliminary data to evaluate (i) the magnitude of changes in blood flow in the bowel before and after feeding and (ii) the differences between preterm and term infants. conditions: Premature conditions: Necrotizing Enterocolitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Evaluation of intestinal perfusion with color Doppler abdominal ultrasound before and after feeding. measure: Time-averaged mean velocity of the superior mesenteric artery measure: Bowel wall perfusion sex: ALL maximumAge: 4 Weeks stdAges: CHILD facility: Children's Hospital of Fudan University (Xiamen Branch) city: Xiamen state: Fujian zip: 361000 country: China name: Haitao Zhu, MD role: CONTACT phone: +86-592-2529586 email: haitao_zhu@fudan.edu.cn name: Haitao Zhu, MD role: PRINCIPAL_INVESTIGATOR lat: 24.47979 lon: 118.08187 hasResults: False

 nctId: NCT06319313 id: JMT101-013 briefTitle: Efficacy and Safety of JMT101 Combined Wth Docetaxel / HB1801 in Patients With Squamous Cell Non-Small Cell Lung Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-07-01 date: 2027-12-01 date: 2024-03-20 date: 2024-03-20 name: Shanghai JMT-Bio Inc. class: INDUSTRY briefSummary: This study is a phase II/III, randomized, controlled, open-label, multi-center study with safety run-in to evaluate the efficacy and safety of JMT101 combined with docetaxel/ HB1801 in Patients with Squamous cell non-small cell lung cancer （sqNSCLC）. conditions: Squamous Cell Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 534 type: ESTIMATED name: JMT101 name: docetaxel name: HB1801 measure: Overall response rate (ORR) measure: Overall Survival (OS) measure: Incidence and severity of adverse events (AE) and serious adverse events (SAE) measure: Progression-free Survival (PFS) measure: Disease Control Rate (DCR) measure: Duration of response（DOR） measure: JMT101 Concentrations in Plasma measure: Total and Free Docetaxel Concentrations in Plasma sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06319300 id: 20240115023245436 briefTitle: Artificial Intelligence-assisted Insulin System in Type 2 Diabetes in General Wards overallStatus: RECRUITING date: 2024-04-19 date: 2026-03-20 date: 2026-05-20 date: 2024-03-20 date: 2024-04-22 name: Shanghai Zhongshan Hospital class: OTHER name: Shanghai Fifth People's Hospital,Fudan University briefSummary: Our study was a single-blind, randomised, controlled, multicentre study. The study was planned to include 140 patients admitted to the general ward for subcutaneous insulin therapy, who were randomly divided into two groups in the ratio of 1:1, one group with an artificial intelligence assisted insulin dosimetry system to adjust the insulin dose to control their blood glucose, and the other group with a physician instituted insulin dosimetry adjustments to control their blood glucose. The effectiveness and safety of the system was confirmed by comparing the glycaemic control and risk of adverse events between the two groups. conditions: Diabetes Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 140 type: ESTIMATED name: AI-assisted insulin dose adjustment model name: doctor's insulin dose adjustment measure: time in target range (3.9-10.0 mmol/L ) measure: sensor glucose measure: capillary blood sugar measure: hypoglycaemic event measure: hyperglycaemic event measure: insulin dosage measure: satisfaction score of doctors measure: Length of hospitalisation measure: Other/Serious Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Hospital, Fudan University status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Xiaoying Li role: CONTACT phone: +862164041990 email: li.xiaoying@zs-hospital.sh.cn lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06319287 id: PRO-00125 briefTitle: Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU) overallStatus: RECRUITING date: 2024-02-27 date: 2025-04-05 date: 2025-07-12 date: 2024-03-20 date: 2024-04-16 name: Rion Inc. class: INDUSTRY name: Professional Education and Research Institute briefSummary: A Phase 2a Multi-Center, Prospective, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects with Diabetic Foot Ulcers (DFU) conditions: Diabetic Foot Ulcer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multi-center, Open Label, Randomized Controlled Clinical Trial Evaluating the Effect of PEP/TISSEEL in the Treatment of Diabetic Foot Ulcers primaryPurpose: TREATMENT masking: NONE maskingDescription: Open Label count: 40 type: ESTIMATED name: PEP (Purified Exosome Product) / TISSEEL measure: Wound Closure measure: Safety measure: Percent Area Reduction of Wound at 12 Weeks measure: Visual Analogue Scale (VAS) for Pain over 12 weeks measure: Semmes-Weinstein Score measure: Wound-Q Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Professional Education & Research Institute (PERI) status: RECRUITING city: Blue Ash state: Ohio zip: 45242 country: United States name: Charles Zelen, M.D. role: CONTACT phone: 540-344-3668 email: cmzelen@mriedu.com name: Morgan Zelen role: CONTACT phone: 203-671-5915 email: mzelen@periedu.com lat: 39.232 lon: -84.37827 hasResults: False

 nctId: NCT06319274 id: COMBAT-ARF briefTitle: Infusion of Prostacyclin vs Placebo for 72-hours in Mechanically Ventilated Patients With Acute Respiratory Failure acronym: COMBAT-ARF overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-30 date: 2026-12-30 date: 2024-03-20 date: 2024-03-20 name: Pär Johansson class: OTHER briefSummary: The purpose of this clinical trial is to investigate the efficacy and safety of continuous intravenous administration of low dose iloprost versus placebo for 72-hours, in 450 mechanically ventilated patients with infectious respiratory failure. The study hypothesis is that iloprost may be beneficial as an endothelial rescue treatment as it is anticipated to deactivate the endothelium and restore vascular integrity in patients suffering from respiratory failure caused by endothelial breakdown, ultimately improving survival. conditions: Acute Respiratory Failure conditions: Endothelial Dysfunction conditions: Pulmonary Infection studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomization active/placebo (1:1) parallel arms primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) The preparation will be done by an unblinded study nurse independent of the including ICU´s, who will be responsible for preparing the investigational drug to be administered in a blinded fashion. Iloprost is a colorless fluid that is to be diluted in 0.9% saline. The infusion pump containing diluted active drug and placebo will be identical in both looks and behavior. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 450 type: ESTIMATED name: Iloprost name: Isotonic saline measure: 28-day mortality measure: 90-day mortality measure: Vasopressor-free days measure: Renal replacement-free days measure: Mechanical ventilation free days measure: Serious adverse reactions (SARs) measure: Serious adverse events (SAEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dept. of Anaesthesia and Intensive Care, Bispebjerg Hospital city: Copenhagen zip: 2400 country: Denmark name: Niels E Clausen, MD role: CONTACT name: Niels E Clausen, MD role: PRINCIPAL_INVESTIGATOR lat: 55.67594 lon: 12.56553 facility: Dept. of Intensive Care, Copenhagen University Hospital Herlev city: Herlev zip: 2730 country: Denmark name: Peter Soee-Jensen, MD role: CONTACT name: Peter Soee-Jensen, MD role: PRINCIPAL_INVESTIGATOR lat: 55.72366 lon: 12.43998 facility: Dept. of Anaesthesia and Intensive Care, Nordsjaelands Hospital city: Hillerød zip: 3400 country: Denmark name: Morten Bestle, MD role: CONTACT name: Morten Bestle, MD role: PRINCIPAL_INVESTIGATOR lat: 55.92791 lon: 12.30081 facility: Department of Anesthesia and Intensive Care Medicine, Zealand University Hospital city: Køge zip: 4600 country: Denmark name: Lars Peter K Andersen, MD, PhD role: CONTACT name: Lars Peter K Andersen, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.45802 lon: 12.18214 hasResults: False

 nctId: NCT06319261 id: 858623 briefTitle: Efficacy of Guided Biofilm Therapy (GBT) for Treatment of Deep Periodontal Pockets. overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2024-12 date: 2024-03-20 date: 2024-03-20 name: University of Baghdad class: OTHER briefSummary: the aim of the study is to evaluate the efficacy of guided biofilm therapy (GBT) for treatment of deep periodontal pockets.

the objectives are

1- To compare the change in the clinical periodontal parameters and microbiological parameters by using real time PCR for P. gingivalis, Aggregatibacter actinomycetemcomitans and Filifactor alocis among sites treated by GBT and conventional hand instrumentation after a period of 3 months and to assess the level of the selected periodontal pathogens in deep periodontal pockets and to estimate and compare deep periodontal pockets which need surgery after 3 months of non-surgical treatment by GBT and conventional hand instrumentation.

the hypothesis is whether there are no differences in in the clinical and microbiological parameters among sites treated by GBT and conventional hand instrumentation after a period of 3 months or there are differences in in the clinical and microbiological parameters among sites treated by GBT and conventional hand instrumentation after a period of 3 months.

The participants will be selected on a consecutive basis from patients referred to the Department of Periodontics, College of Dentistry, University of Baghdad.

For each patient, each site will be randomly assigned to either treatment protocol:

1. Sites treated with GBT.
2. Sites treated with conventional manual instrumentation only. conditions: Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 25 type: ESTIMATED name: guided biofilm therapy name: root surface debridement measure: Periodontal pocket depth (PPD) measure: Plaque index measure: Bleeding on probing measure: Relative attachment level measure: Changes in the bacterial load sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06319248 id: 24-000121 briefTitle: Use of Midodrine in Septic Shock Patients overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-05-30 date: 2029-07-30 date: 2024-03-20 date: 2024-04-16 name: Mayo Clinic class: OTHER briefSummary: This study is being done to determine if early administration of Midodrine can improve outcomes by maintaining a higher mean blood pressure off of intravenous medications. Researchers want to see if Midodrine can help people with sepsis need fewer vasopressors, which could mean shorter hospital stays, less time with uncomfortable tubes, and a smoother recovery overall. conditions: Sepsis conditions: Low Blood Pressure studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 270 type: ESTIMATED name: Midodrine name: Placebo measure: Time alive and without vasopressor support measure: Total vasopressor requirements measure: Central venous access duration measure: Cumulative fluid balance over the first 48 hours measure: Cumulative fluid balance up to 7 days of ICU stay measure: ICU Length of Stay measure: Hospital Length of Stay measure: ICU, hospital, and organ support-free days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic Minnesota city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06319235 id: DUO2022_01 id: 2022-002412-23 type: EUDRACT_NUMBER briefTitle: Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG® overallStatus: RECRUITING date: 2023-10-27 date: 2025-12-31 date: 2025-12-31 date: 2024-03-19 date: 2024-03-19 name: MB PHARMA s.r.o. class: INDUSTRY briefSummary: DUOFAG® is a phage cocktail containing bacteriophages active against Staphylococcus aureus and Pseudomonas aeruginosa. It is an investigational medicinal product for the treatment of surgical site infections caused by S. aureus and P. aeruginosa.

The primary objective of the study is to demonstrate the safety of DUOFAG® and the clinical and microbiological change within 10 weeks after the start of treatment or until healing. conditions: Surgical Site Infection conditions: Staphylococcus Aureus Infection conditions: Pseudomonas Aeruginosa Infection conditions: Bacterial Infections conditions: Surgical Wound Infection studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 52 type: ESTIMATED name: IMP name: Placebo measure: Primary endpoint - Cohort 1 measure: Primary endpoint - pooled Cohorts 1 & 2 measure: Safety endpoints (assessed in pooled Cohorts 1 & 2) measure: Microbiological endpoints (assessed in pooled Cohort 1 and Cohort 2) measure: Clinical efficacy endpoints sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Anne's University Hospital Brno status: RECRUITING city: Brno state: Czech Republic zip: 602 00 country: Czechia name: Dominik Maduda, MUDr. role: CONTACT phone: +420 543 182 432 email: dominik.maduda@fnusa.cz name: Kateřina Bílá, MUDr. role: CONTACT phone: +420 543 182 451 email: katerina.bila@fnusa.cz lat: 49.19522 lon: 16.60796 hasResults: False

 nctId: NCT06319222 id: 23-007870 briefTitle: Implementation of a Digital Clinic for Alcohol-associated Liver Disease and Alcohol Use Disorder (DALC) acronym: DALC overallStatus: RECRUITING date: 2024-03-12 date: 2024-09 date: 2025-04 date: 2024-03-19 date: 2024-04-01 name: Mayo Clinic class: OTHER name: Ria Health briefSummary: The purpose of this study is to determine whether a multidisciplinary digital clinic will improve health outcomes, reduce costs, increase access, and improve provider satisfaction.

The primary aim of this study is to improve clinical outcomes in patients with ALD through the implementation of a novel digital health platform for personalized multi-disciplinary treatment of patients with ALD and AUD. Secondary aims include improvement in provider and patient-reported outcomes including satisfaction with AUD treatment. conditions: Alcohol Use Disorder conditions: Liver Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: DALC Digital Clinic measure: Median delta MELD-3.0 from baseline to end of study. measure: Sustained alcohol abstinence measure: Reduction of Number of hospitalizations measure: Greater provider satisfaction in DALC arm sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic Arizona status: RECRUITING city: Scottsdale state: Arizona zip: 85259 country: United States name: Blanca C Lizaola-Mayo, MD role: CONTACT phone: 480-342-1094 email: dalc@mayo.edu lat: 33.50921 lon: -111.89903 facility: Mayo Clinic status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Douglas Simonetto, MD role: CONTACT phone: 507-284-1649 email: dalc@mayo.edu name: Camille Kezer, MD role: CONTACT phone: 507-284-2687 email: dalc@mayo.edu lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06319209 id: 2024KY023 briefTitle: Timing of Surgery and the Evolution of Postoperative Outcomes in Breast Cancer Patients Undergoing Surgical Intervention Following Recovery From SARS-CoV-2 Infection overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-01 date: 2023-03-31 date: 2024-03-31 date: 2024-03-19 date: 2024-03-19 name: Fujian Medical University Union Hospital class: OTHER briefSummary: Perioperative SARS-CoV-2 infection significantly increases the risk of postoperative complications and mortality, while also exerting long-lasting impacts on multiple organs and systems. Due to the curtailment or cessation of non-emergency surgeries during the initial phase of the pandemic, there is a lack of evidence regarding the optimal timing and medium- to long-term postoperative outcomes of surgical intervention in breast cancer patients with prior SARS-CoV-2 infection, particularly after vaccination. We aim to investigate whether prior SARS-CoV-2 infection increases the risk of postoperative adverse outcomes in breast cancer patients and determine the optimal timing for surgical intervention during the pandemic, as well as to longitudinally assess the evolution of postoperative adverse outcomes within one year after COVID-19 and identify associated risk factors. conditions: Breast Cancer conditions: COVID-19 conditions: Postoperative Complications studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 392 type: ACTUAL name: Preoperative resolved COVID-19 measure: 30-day postoperative outcomes measure: Postoperative outcomes at the time of the initial tumor assessment after surgery measure: 12-month postoperative outcomes sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Medical University Union Hospital city: Fuzhou state: Fujian country: China lat: 26.06139 lon: 119.30611 hasResults: False

 nctId: NCT06319196 id: Clear Me briefTitle: Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma acronym: ClearMe overallStatus: RECRUITING date: 2024-05-01 date: 2027-02-15 date: 2030-02-15 date: 2024-03-19 date: 2024-04-22 name: University Health Network, Toronto class: OTHER briefSummary: Clear-Me is a biomarker-driven phase II study that tests whether the combination anti- lymphocyte-activation gene-3 (LAG3)/anti-programmed cell death protein 1(PD-1) inhibition Bristol-Myers Squibb (BMS986213) is superior to anti-PD-1 inhibition in patients with detectable circulating tumor deoxyribonucleic acid (ctDNA) following definitive surgery for high risk melanoma. Patients will be allocated to either Arm A or Arm B via the process of randomization. The randomization process will be stratified according to stage (Stage 2A/2B/3A/3B/3C/3D or 4), to ensure absolute balance between stage groups. The investigators are choosing only 1 stratification factor, disease stage, as the investigators consider stage being the most significant prognosticating variable. Each stage represents a biologically distinct entity with varying recurrence rate outcomes. Block randomization will be performed to ensure equal sample sizes in the combination and monotherapy arms. At least 54 patients will be included in the randomized part of the study. The investigators are expecting approximately 20% of the patients to have detectable ctDNA after definite surgery. Therefore, approximately 270 patients are expected to be enrolled and tested for ctDNA in the entire study. conditions: Cutaneous Melanoma conditions: Melanoma Stage IV conditions: Mucosal Melanoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: Opdualag name: Nivolumab measure: Clearance of ctDNA at 12 months after starting adjuvant treatment. ctDNA clearance is defined as no detection of plasma ctDNA measure: Recurrence-free survival (RFS) measure: Number and severity of treatment related adverse events according to CTCAE v5.0. measure: Clearance of ctDNA measure: Measured changes of biomarker ctDNA measure: Methylation patterns of biomarker ctDNA using circulating free methylated DNA immunoprecipitation and sequencing (cfMeDIPseq) assay and correlation with ctDNA total variant allele frequency (VAF) detection. measure: Quality of life assessment using Quality of Life Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UHN- Princess Margaret Cancer Center status: RECRUITING city: Toronto state: Ontario zip: M5G 1Z5 country: Canada name: Anna Spreafico, MD role: CONTACT phone: 416-946-2263 email: anna.spreafico@uhn.ca lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06319183 id: 2023tjdxsy045 briefTitle: The Regulatory Function of Inhaled Asthma Medication Salbutamol on Thermogenesis overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2025-03 date: 2024-03-19 date: 2024-03-19 name: Tongji University class: OTHER briefSummary: In recent years, obesity and its complications have severely threatened human health. Given the limited options for obesity treatment currently available, there is an urgent need to develop new drugs and therapeutic methods to alleviate patient suffering.

Mammalian adipose tissue is primarily divided into energy-storing white fat and energy-consuming brown fat. Physical activity, exposure to cold, and other factors induce the transformation of white fat into energy-consuming brown fat, a process known as adipose tissue browning. The occurrence of adipose tissue browning increases the body's energy expenditure and dissipates it in the form of heat, effectively mitigating the onset of obesity. Therefore, the regulatory mechanism of adipose tissue browning has become an important potential target for obesity treatment.

The main component of asthma medication is the β2 adrenergic receptor agonist, which can act on GPCR receptors on the surface of the tracheal smooth muscle through inhalation, causing bronchial dilation and thereby alleviating asthma symptoms. Preliminary experimental results have shown that pulmonary epithelial cells can secrete protein factors that regulate the browning process of adipose tissue, and the expression of these secretory factors is regulated by the cell surface GPCR receptor signaling pathway. Therefore, our goal is to validate the regulatory effect of the asthma medication salbutamol on adipose tissue browning through inhalation administration in humans, establishing a new function for asthma medication in obesity treatment. conditions: Effect of Asthma Medication Salbutamol on Obesity studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Salbutamol measure: Temperature of Scapular Region sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06319170 id: TV44749-NPC-10205 briefTitle: Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder overallStatus: RECRUITING date: 2024-03-28 date: 2024-12-11 date: 2024-12-11 date: 2024-03-19 date: 2024-04-24 name: Teva Branded Pharmaceutical Products R&D, Inc. class: INDUSTRY briefSummary: The primary objective of the study is to characterize the pharmacokinetics of 3 formulations of olanzapine.

A secondary objective is to evaluate the safety and tolerability of 3 formulations of olanzapine.

Another secondary objective is to characterize the pharmacokinetics of ZYPREXA.

The planned duration of the study for each participant is 19 weeks. conditions: Schizophrenia, Schizoaffective Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 95 type: ESTIMATED name: Olanzapine Extended Release name: Olanzapine measure: Maximum observed plasma drug concentration (Cmax) measure: Area under the plasma drug concentration-time curve (AUC) measure: AUC extrapolated to infinity (AUC0-∞) measure: Number of participants with at least 1 treatment-emergent adverse event (TEAE) measure: Number of participants with at least 1 serious adverse event (SAE) measure: Cmax of ZYPREXA measure: AUC of ZYPREXA measure: Apparent plasma terminal elimination rate constant (λz) of ZYPREXA sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Teva Investigational Site 15727 status: RECRUITING city: Hollywood state: Florida zip: 33024 country: United States lat: 26.0112 lon: -80.14949 facility: Teva Investigational Site 15726 status: RECRUITING city: Marlton state: New Jersey zip: 08053 country: United States lat: 39.89122 lon: -74.92183 hasResults: False

 nctId: NCT06319157 id: SYSKY-2023-1263-02 briefTitle: Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction overallStatus: RECRUITING date: 2024-03 date: 2028-11 date: 2028-11 date: 2024-03-19 date: 2024-03-19 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: For patients refusing implants for breast reconstruction after cancer surgery, autologous tissue flap reconstruction using the latissimus dorsi muscle is an alternative. Conventional surgery leaves a long incision on the back, affecting aesthetics and quality of life. Minimal access techniques result in a smaller, more concealable scar. While previous studies suggest its safety and effectiveness, most are retrospective. To further validate patient satisfaction and short-term outcomes, a prospective, randomized controlled trial comparing minimal access with conventional surgery is planned. The primary endpoint is Breast Q-satisfaction with back score at 6 months. Secondary outcomes include other Breast Q subscales, surgical metrics, and complications. The study aims to enroll 94 patients in total, providing evidence for surgical decision-making in breast cancer reconstruction. conditions: Breast Neoplasms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 94 type: ESTIMATED name: minimal access breast reconstruction with a latissimus dorsi muscle flap name: conventional breast reconstruction with a latissimus dorsi muscle flap measure: Breast Q-satisfaction with back measure: Patient satisfaction measure: Latissimus dorsi acquisition time measure: Intraoperative blood loss measure: Postoperative pain measure: Postoperative complications sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510120 country: China name: Shicheng Su, M.D., Ph.D. role: CONTACT phone: +86 13632394954 email: lnl_trial@126.com name: Erwei Song, M.D., Ph.D. role: CONTACT phone: +86 13719237746 email: lnl_trial@126.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06319144 id: KYLL20240306-1 briefTitle: Effect of Intravenous 5% Dextrose Infusion During Recovery From Anesthesia on the Quality of Early Postoperative Recovery in Patients Undergoing Painless Gastrointestinal Endoscopy overallStatus: RECRUITING date: 2024-03-14 date: 2024-03-14 date: 2024-05-05 date: 2024-03-19 date: 2024-03-19 name: Weifang Medical University class: OTHER briefSummary: The aim of this study was to determine the effect of intravenous infusion of 5% dextrose injection during the recovery period of anesthesia for painless gastroenteroscopy on the patient's blood glucose level, incidence of hypoglycemia and time of awakening from anesthesia, postoperative vertigo, postoperative nausea and vomiting, and quality of recovery in the early postoperative period. conditions: Insulin Resistance conditions: Postoperative Nausea and Vomiting conditions: Quality of Recovery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: 5% glucose name: 0.9% Normal Saline measure: Preoperative blood glucose 30min measure: Postoperative blood glucose 30min measure: Postoperative nausea and vomiting measure: Postoperative nausea and vomiting measure: Postoperative nausea and vomiting measure: Postoperative nausea and vomiting measure: Anesthesia awakening time measure: Dizziness level measure: Dizziness level measure: Dizziness level measure: Quality of postoperative recovery (QoR40) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lin Cheng status: RECRUITING city: Weifang state: Shandong zip: 261041 country: China name: Lin Cheng, B.S role: CONTACT phone: 17667404256 email: 1318216353@qq.com lat: 36.71 lon: 119.10194 hasResults: False

 nctId: NCT06319131 id: Tipharosis briefTitle: Nadroparin Versus TIPS in Cirrhotic Patients With Refractory Asymptomatic PVT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-30 date: 2026-05-30 date: 2024-03-19 date: 2024-03-21 name: Shanghai Zhongshan Hospital class: OTHER name: Shanghai 6th People's Hospital name: ShuGuang Hospital name: Tongji Hospital name: Renmin Hospital of Wuhan University briefSummary: The purpose of this study is to evaluate the comparative effectiveness of nadroparin versus transjugular intrahepatic portosystemic shunt in cirrhotic patients with refractory asymptomatic portal vein thrombosis using a design of a multicenter, randomized controlled trial conditions: Portal Vein Thrombosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: TIPS name: Nadroparin measure: complete recanalization rate of PVT measure: partial recanalization rate of PVT measure: Bleeding rate measure: Mortality sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06319118 id: JD-LK2023091-I01 briefTitle: A Clinical Study of Dihydroergotine Mesylate Extended-release Tablets for the Treatment of Drooling in Parkinson's Disease. overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-01 date: 2024-06-30 date: 2024-12-30 date: 2024-03-19 date: 2024-03-19 name: Second Affiliated Hospital of Soochow University class: OTHER briefSummary: Objective: To evaluate the efficacy and safety of dihydroergotine mesylate extended-release tablets for salivation in Parkinson\&#39;s disease Study content: Using a randomized, double-blind, placebo-controlled study design, 120 patients with Parkinson\&#39;s disease and cognitive impairment were enrolled, and the treatment was followed up for 12 weeks: dihydroergotine mesylate sustained-release tablets + conventional treatment (treatment group patients, 80 cases), placebo + conventional treatment (control group patients, 40 cases), and the main indicators were observed: the improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was observed, and the secondary indicators were observed: the effect of dihydroergotine mesylate sustained-release tablets on the cognitive function of PD patients was observed.

Expected results: The improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was significantly different from that of the placebo control group. The dihydroergotine mesylate sustained-release tablet group had a significant effect on the cognitive function of PD patients. conditions: Salivation in Parkinson's Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Placebo name: dihydroergotine mesylate sustained-release tablets measure: the objective weight of saliva in patients with Parkinson's disease changed from baseline sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Arilliated Hospital of Soochow University city: Suzhou state: Jiangsu zip: 215004 country: China lat: 31.30408 lon: 120.59538 hasResults: False

 nctId: NCT06319105 id: 775736 briefTitle: PathToScale: An Implementation Evaluation overallStatus: RECRUITING date: 2024-03-26 date: 2026-04-01 date: 2026-04-01 date: 2024-03-19 date: 2024-03-29 name: Georgetown University class: OTHER name: AIDS Vaccine Advocacy Coalition name: Centers for Disease Control and Prevention name: Center for the Development of People name: Cooper/Smith name: Elizabeth Glaser Pediatric AIDS Foundation name: Family Health Services name: Healthqual name: Johns Hopkins Research Project, Malawi name: Johns Hopkins Bloomberg School of Public Health name: Kamuzu University of Health Sciences name: Blantyre District Health Office, Malawi name: Lilongwe District Health Office, Malawi name: Lighthouse Trust name: Ministry of Health, Malawi name: National AIDS Commission, Malawi name: Pakachere Institute of Health and Development Communication name: Partners in Hope name: Population Services International name: University of North Carolina name: United States Agency for International Development (USAID) name: United States President's Emergency Plan for AIDS Relief name: Quantitative Engineering Design name: Clinton Health Access Initiative-Malawi briefSummary: The purpose of this study is to evaluate the implementation and clinical outcomes of expanded pre-exposure prophylaxis delivery modalities and service delivery points offering long-acting injectable cabotegravir and oral pre-exposure prophylaxis to high-priority groups through diverse delivery channels. conditions: Oral Pre-exposure Prophylaxis (PrEP) conditions: Long-acting Injectable Cabotegravir for PrEP studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 9900 type: ESTIMATED name: Standard intervention: Offer PrEP choice measure: Pre-exposure prophylaxis uptake by modality measure: Pre-exposure prophylaxis uptake by delivery channel measure: Pre-exposure prophylaxis uptake by population measure: Pre-exposure prophylaxis continuation by modality measure: Pre-exposure prophylaxis continuation by delivery channel measure: Pre-exposure prophylaxis continuation by population measure: Rates of switching between oral and injectable pre-exposure prophylaxis measure: Implementation readiness measure: Pregnancy rates among long-acting injectable cabotegravir for pre-exposure prophylaxis users measure: Pregnancy outcomes among long-acting injectable cabotegravir for pre-exposure prophylaxis users sex: ALL minimumAge: 15 Years maximumAge: 110 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Community Health Science Unit status: RECRUITING city: Lilongwe country: Malawi name: W Ozituosauka role: CONTACT lat: -13.96692 lon: 33.78725 hasResults: False

 nctId: NCT06319092 id: 2023/175 briefTitle: Immersive Virtual Reality Version of the 6 Minute Pegboard and Ring Test overallStatus: COMPLETED date: 2023-06-01 date: 2023-10-01 date: 2023-12-01 date: 2024-03-19 date: 2024-03-19 name: Gaziantep Islam Science and Technology University class: OTHER briefSummary: The 6 Minute Pegboard and Ring Test is a test applicable to the upper extremities. The upper extremity plays an important role in activities of daily living, especially in tasks related to reaching, grasping and holding objects. Various activities of daily living, such as combing hair, brushing teeth and picking up objects, require supported or unsupported upper limb activity. Therefore, evaluation of upper extremity function is important. In addition, it is a simple test, it is also seen as a game, its application is functional, and there is no need for expensive equipment. Its validity and reliability have been demonstrated only for patients with Chronic Obstructive Pulmonary Disease (COPD) and healthy adults. In addition, to the best of our knowledge, the suitability of this test in a virtual environment has not been evaluated in the literature. Therefore, the main aim of this study is to examine the applicability of this test in a virtual environment. conditions: Healthy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 30 type: ACTUAL measure: 6 Minute Pegboard and Ring Test measure: Immersive virtual reality version of the 6 Minute Pegboard and Ring Test measure: Quick Shoulder-Hand Syndromes Questionnaire measure: Assessment of handgrip measure: 9 Hole Peg Test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gaziantep İslamic Science and Technology University city: Gaziantep state: Şahinbey zip: 27000 country: Turkey lat: 37.05944 lon: 37.3825 hasResults: False

 nctId: NCT06319079 id: UCTH 2024 briefTitle: Effect of Consumption of a Milk Product Designed for Lactating Women on Human Milk Composition overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2027-07 date: 2024-03-19 date: 2024-03-19 name: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri class: OTHER briefSummary: Vulnerable populations, who have deficient diets, may produce human milk (HML) that is not adequate in all nutrients and this will have consequences on the growth and development of the child. In 2021 at IDIP, a specific milk product for pregnant and lactating women Super Mil Mamá ( SMM, whole milk powder fortified with multiple vitamins, minerals and DHA ) has been designed and developed as part of a key strategy to incorporate in public policies for the first 1000 days of life. However, the potential benefits of this product have not yet been evaluated at the population level.

The main objective is to evaluate the effect of the consumption of a milk product (SMM) designed for lactating women on the composition of human milk and the nutritional status of iron and DHA in infant red blood cells in a vulnerable population through a randomized, triple-blind, controlled clinical trial.

Specific objectives To compare the concentrations of DHA, Vitamins A, E, and D, Iron, Iodine, Zinc and Calcium in human milk before and after dietary supplementation with SMM.

To compare the concentrations of DHA, Vitamins A, E, D and Zinc in blood and the nutritional status of maternal iron before and after dietary supplementation with SMM.

To analyze the relationship between micronutrients measured in maternal blood and human milk after dietary supplementation with SMM.

To compare the concentrations of micronutrients measured in blood and human milk in women who received SMM and those who received commercial milk (CM) at the end of supplementation.

To compare the iron nutritional status and DHA content in red blood cells of infants of mothers who consumed SMM or LC.

To evaluate the relationship between the concentration of micronutrients in human milk and infant growth during the first six months of life. conditions: Lactating Mothers conditions: Infants studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: The powder milk containers (both SMM and commercial milk) will be packaged by Addvance SA (in the Province of Santa Fe), each of the products will have a label that differentiates them but only the company Addvance SA will know that information. In this project, neither the participating mothers, researchers, and technical staff assigned to the project nor the professional who performs the data analysis knows what product each participant will receive. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Fortified powder milk name: Powder milk measure: breast milk DHA concentration measure: breast milk Vitamin A concentration measure: breast milk Vitamin E concentration measure: breast milk Vitamin D concentration measure: breast milk Zinc concentration measure: breast milk Calcium concentration measure: breast milk Iron concentration measure: breast milk Iodine concentration measure: mother red blood cell DHA concentration measure: mother Vit A concentration measure: mother Vit E concentration measure: mother Vit D concentration measure: mother Zinc concentration measure: mother hemoglobin concentration measure: mother serum ferritin concentration measure: child hemoglobin concentration measure: child serum ferritin concentration measure: child red blood cell DHA concentration sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06319066 id: RGNS65-152 briefTitle: Customized Foot Orthoses With Orthotic Wedges for Plantar Heel Pain overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-11-30 date: 2024-12-31 date: 2024-03-19 date: 2024-03-19 name: Mahidol University class: OTHER briefSummary: The present study will use a randomized controlled trial (RCT) to determine the effectiveness of customized foot orthosis (CFO) for the treatment of patients with PHP. Three treatment groups including the CFO without wedge, the CFO with wedge type 1 (W1), and the CFO with wedge type 2 (W2) will be randomly assigned to each participant by a computer-generated randomization. The opaque-sealed envelopes will be used to allocate the groups of participant. conditions: Foot Orthoses conditions: Fasciitis, Plantar studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: The present study will use a randomized controlled trial (RCT) to determine the effectiveness of CFO for the treatment of patients with PHP. Three treatment groups including the CFO without wedge, the CFO with W1, and the CFO with W2 will be randomly assigned to each participant by a computer-generated randomization. The opaque-sealed envelopes will be used to allocate the groups of participant. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants will be allocated to the control (CFO without wedge) or experimental (CFO with W1 or W2) groups according to the seal-envelop randomization technique. Then, they will be assessed all outcomes for the baseline including pain intensity, foot function, plantar fascia thickness, balance outcomes, and gait parameters by the 2nd physical therapist. And the participants will receive the assigned treatment by the 1st physical therapist. whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: orthotic wedge name: CFO measure: Pain intensity and foot function measure: Plantar Fascia Thickness measure: Gait assessment measure: Balance assessment measure: Low back and Lower-extremity pain measure: Transversus abdominis (TrA) Thickness measure: Subjective assessment measure: Physical assessment sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06319053 id: NL85402.078.23 briefTitle: The Turbine-based Insufflator Safety and Feasibility Study acronym: TBI overallStatus: RECRUITING date: 2024-03-04 date: 2024-09 date: 2024-10 date: 2024-03-19 date: 2024-04-10 name: Erasmus Medical Center class: OTHER name: Politecnico di Milano University name: Health∼Holland, Topsector Life Sciences & Health name: Spatium Medical B.V. name: IDE Group B.V. briefSummary: The turbine-based insufflator for minimal access surgery provides a new technological basis for minimal invasive surgery insufflation. Turbine technology permits highly accurate pressure control, an intra-abdominal volume that is dynamically adapted to ventilation, and oscillometric measurements of abdominal compliance. This first-in-human study aims to evaluate technologic feasibility in terms of pressure stability performance and the safety of the device. conditions: Laparoscopy conditions: Pneumoperitoneum studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: Consecutive patients from who informed consent can be acquired. The number of twelve participants was determined in conjunction with the Ethical Board of Erasmus MC primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 12 type: ESTIMATED name: Turbine-based insufflator measure: Occurrence of (serious) adverse device effects [Safety and feasibility of the device] measure: Observation of insufflation pressure stability by continuously monitoring and recording. measure: Gas volume exchange measure: Estimation of the abdominal compliance measure: Intra-abdominal target pressure in relation to the abdominal compliance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus MC, University Medical Center Rotterdam status: RECRUITING city: Rotterdam state: Zuid Holland zip: 3015 GD country: Netherlands name: J. Vlot, MD, PhD role: CONTACT phone: +31107039568 email: john.vlot@erasmusmc.nl name: A.I. de Jong, MD role: CONTACT phone: +31107037641 email: a.i.dejong@erasmusmc.nl lat: 51.9225 lon: 4.47917 hasResults: False

 nctId: NCT06319040 id: MEDİPOL MEGA 1 briefTitle: The Effect Of Addıtıonal Surgery On Muscle Strength, Proprıoceptıon And Balance In Anterıor Crucıate Lıgament Surgery overallStatus: COMPLETED date: 2018-12-06 date: 2019-03-07 date: 2019-06-07 date: 2024-03-19 date: 2024-03-19 name: Medipol University class: OTHER briefSummary: Meniscal tears and RAMP lesions are frequently seen together with ACL injuries. The aim of this study was to evaluate the effects of meniscus repair and RAMP lesion repair ACL reconstruction surgery in terms of muscle strength, proprioception, and balance. In our study, the clinical outcomes of both anterior cruciate ligament reconstruction (ACLR), medial meniscus repair (MR) and RAMP lesion repair (RR) have been compared with those of isolated ACLR. conditions: Anterior Cruciate Ligament Injuries conditions: Meniscus Lesion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 45 type: ACTUAL name: Muscle strength measurement name: Knee joint proprioception name: Balance name: Fall risk test name: Tegner Activity Level name: Lysholm Knee Scoring Scale measure: muscle strength measurement sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Istanbul Medipol University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06319027 id: EAF223 id: NCI-2023-08557 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAF223 type: OTHER domain: ECOG-ACRIN Cancer Research Group id: EAF223 type: OTHER domain: CTEP id: U10CA180820 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180820 briefTitle: Identifying Findings on Brain Scans That Could Help Make Better Predictions About Brain Cancer Progression, The GABLE Trial overallStatus: NOT_YET_RECRUITING date: 2024-04-12 date: 2027-05-31 date: 2027-05-31 date: 2024-03-19 date: 2024-03-19 name: ECOG-ACRIN Cancer Research Group class: NETWORK briefSummary: This phase II trial studies whether different imaging techniques can provide additional and more accurate information than the usual approach for assessing the activity of tumors in patients with newly diagnosed glioblastoma. The usual approach for this currently is magnetic resonance imaging (MRI). This study is trying to learn more about the meaning of changes in MRI scans after treatment, as while the appearance of some of these changes may reflect progressing tumor, some may be due the treatment. Dynamic susceptibility contrast (DSC)-MRIs, along with positron emission tomography (PET) and/or magnetic resonance (MR) spectroscopy, may help doctors tell which changes are a reflection of the treatment and which changes may be due to progressing tumor. conditions: Glioblastoma, IDH-Wildtype studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging name: Fluciclovine F18 name: Gadolinium-Chelate name: Magnetic Resonance Spectroscopy name: Positron Emission Tomography measure: Overall survival (OS) measure: Event free survival (EFS) measure: True disease progression and pseudo-progression (PsP) measure: Progression-free survival (PFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06319014 id: 23-001568 briefTitle: Physical Activity to Mitigate PreEclampsia Risk acronym: PAMPER overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2026-04-01 date: 2026-10-01 date: 2024-03-19 date: 2024-03-19 name: East Carolina University class: OTHER briefSummary: The purpose of this study is to compare the effects of aerobic (AE), resistance (RE), and combination (AERE) exercise throughout pregnancy on selected maternal and fetal/neonatal physiological variables in women at-risk for preeclampsia. The central hypothesis of this project is that exercise will decrease severity and occurrence of preeclampsia symptoms, thus improving maternal, pregnancy, and birth outcomes.

Aim 1. Determine the influence of different exercise modes during pregnancy at risk of preeclampsia on maternal cardiometabolic health.

Aim 2. Determine the most effective exercise mode in pregnancy at risk of preeclampsia on improving birth and infant health outcomes. conditions: Pre-Eclampsia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pregnant women will be randomized to one of four groups: aerobic exercise, resistance exercise, combination (aerobic + resistance), or control (no exercise). All exercise participants will be prescribed exercise that meets guidelines of the American College of Obstetricians and Gynecologists (ACOG), American College of Sports Medicine (ACSM), and the American Heart Association (AHA); 150 minutes per week, moderate intensity (60-80% aerobic capacity, Rating of Perceived Exertion, rating of perceived exertion (RPE), 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data. primaryPurpose: PREVENTION masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 224 type: ESTIMATED name: Exercise Modes measure: Systolic Blood Pressure (16wks) measure: Systolic Blood Pressure (20wks) measure: Systolic Blood Pressure (24wks) measure: Systolic Blood Pressure (28wks) measure: Systolic Blood Pressure (32wks) measure: Systolic Blood Pressure (36wks) measure: Maternal Cardiometabolic Risk (CMR) Score measure: Symptom Occurrence measure: Placental Efficiency measure: Birth Weight measure: Infant Cardiometabolic Risk (CMR) Score measure: Maternal Heart Rate (16wks) measure: Maternal Heart Rate (20wks) measure: Maternal Heart Rate (24wks) measure: Maternal Heart Rate (28wks) measure: Maternal Heart Rate (32wks) measure: Maternal Heart Rate (36wks) measure: Maternal Blood Pressure (16wks) measure: Maternal Blood Pressure (20wks) measure: Maternal Blood Pressure (24wks) measure: Maternal Blood Pressure (28wks) measure: Maternal Blood Pressure (32wks) measure: Maternal Blood Pressure (36wks) measure: Maternal Body Fat % (16wks) measure: Maternal Body Fat % (20wks) measure: Maternal Body Fat % (24wks) measure: Maternal Body Fat % (28wks) measure: Maternal Body Fat % (32wks) measure: Maternal Body Fat % (36wks) measure: Maternal Circumferences (16wks) measure: Maternal Circumferences (20wks) measure: Maternal Circumferences (24wks) measure: Maternal Circumferences (28wks) measure: Maternal Circumferences (32wks) measure: Maternal Circumferences (36wks) measure: Gestational Weight Gain measure: Delivery Mode measure: Maternal Blood Glucose (16wks) measure: Maternal Blood Glucose (20wks) measure: Maternal Blood Glucose (24wks) measure: Maternal Blood Glucose (28wks) measure: Maternal Blood Glucose (32wks) measure: Maternal Blood Glucose (36wks) measure: Maternal Blood Lipids (16wks) measure: Maternal Blood Lipids (20wks) measure: Maternal Blood Lipids (24wks) measure: Maternal Blood Lipids (28wks) measure: Maternal Blood Lipids (32wks) measure: Maternal Blood Lipids (36wks) measure: Maternal Plasma Inflammatory Markers (16wks) measure: Maternal Plasma Inflammatory Markers (20wks) measure: Maternal Plasma Inflammatory Markers (24wks) measure: Maternal Plasma Inflammatory Markers (28wks) measure: Maternal Plasma Inflammatory Markers (32wks) measure: Maternal Plasma Inflammatory Markers (36wks) measure: -omics Metabolites (16wks) measure: -omics Metabolites (20wks) measure: -omics Metabolites (24wks) measure: -omics Metabolites (28wks) measure: -omics Metabolites (32wks) measure: -omics Metabolites (36wks) measure: Cord Blood and Placental Inflammatory Markers measure: Cord Blood and Placental -omics Metabolites measure: Infant Body Morphometric Measures sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06319001 id: 2688791 briefTitle: Cardiovascular Reactivity to Physical Stress acronym: REACT overallStatus: RECRUITING date: 2024-02-19 date: 2027-01-01 date: 2027-01-01 date: 2024-03-19 date: 2024-03-19 name: Western Norway University of Applied Sciences class: OTHER briefSummary: It is well-accepted that an exaggerated blood pressure (BP) response to physical stress has a prognostic value, indicating a higher cardiovascular risk (e.g., sudden cardiac death, myocardial infarction, future hypertension, and left ventricular hypertrophy). However, there is a limited understanding of the underlying mechanisms and therapuetic strategies modulating this response. Therefore, this pilot project aims to explore whether one session of low-volume high-intensity interval training (low-volume HIIT) or combined intermittent heat and cold bath (sauna+cold bath) can decrease BP responses to physical stress. Furthermore, the secondary goal is to investigate whether one brief session learning about positive stress expectations magnifies the decrease in BP following low-volume HIIT and sauna+ cold bath. conditions: Blood Pressure conditions: Stress, Physiological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Combined randomized controlled trial with two parallel groups primaryPurpose: OTHER masking: NONE count: 58 type: ESTIMATED name: Low-volume high intensity exercise name: Combined intermittent sauna and cold water bath (sauna+cold bath). measure: Blood pressure (unit: mmHg) response to laboratory stressors measure: Resting blood pressure (mmHg). measure: Endothelial function (% dilation) measure: Subjective ratings of expectancies (point score). sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Western Norway University of Applied Sciences status: RECRUITING city: Bergen state: Vestland zip: 5063 country: Norway name: Ann-Katrin Grotle role: CONTACT phone: +4790960580 email: ann-katrin.grotle@hvl.no lat: 60.39299 lon: 5.32415 hasResults: False

 nctId: NCT06318988 id: S67030 briefTitle: Outcomes of Different Treatment Options in Chronic Venous Disease acronym: VOS overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-11-01 date: 2027-05-01 date: 2024-03-19 date: 2024-03-19 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: This study aims to describe conservative and invasive treatments for patients with chronic venous disease (CVD) in Belgium, and their association with clinical and patient-reported outcomes during a follow-up of 24 months. conditions: Chronic Venous Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: Radiofrequency ablation using Closure fast name: Aethoxysclerol name: Daflon name: Compression stocking measure: Change in Chronic Venous Insufficiency QOL questionnaire- 20 (CIVIQ-20) score measure: Intervention as secondary/add-on treatment measure: The change in the Chronic Venous Insufficiency QOL questionnaire-20 score (CIVIQ-20) measure: The change in the clinical part of the Clinical, Etiological, Anatomical and Pathophysiological classification (CEAP classification) measure: The change in the revised Venous Clinical Severity Score (rVCSS) measure: The change in the symptoms, recorded with a questionnaire measure: The change in satisfaction score measure: Adverse Events (AEs). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06318975 id: RAPTOR id: R01AA029074 type: NIH link: https://reporter.nih.gov/quickSearch/R01AA029074 briefTitle: Text-Based Messaging Strategies for Preventing Subsequent Problematic Alcohol Use overallStatus: RECRUITING date: 2023-12-01 date: 2027-12-31 date: 2028-12-31 date: 2024-03-19 date: 2024-03-19 name: University of Virginia class: OTHER name: University of Memphis name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: Binge drinking, and its health/social consequences are substantial public health concerns, with a high prevalence in young adults, especially in the US military. Alcohol consumption in the military is very high and normative, but there is zero tolerance for alcohol-related legal trouble, and Air Force Airmen who experience this (e.g., DUI, sexual assault) typically receive a disciplinary action referred to as an Alcohol Related Incident (ARI).

Brief Alcohol Interventions (BAIs) for alcohol misuse are effective in young adults who report binge drinking. Many BAI studies targeted young adults who drink hazardously; these individuals are typically not interested in abstaining but may try decreasing the amount or change the manner in which they drink in order to reduce harmful consequences. The investigators previously published the results of a BAI group-based intervention that reduced ARIs in over 150,000 Airmen on average by 16%. Since 2010, the BAI has been disseminated to most USAF Airmen in Technical Training. However, it is clear additional research is needed to enhance the efficacy of the intervention and reduce risks associated with problem drinking. One strategy to improve health outcomes is well-timed, tailored, and automated text messages. Building on the researchers' preliminary study where text messages reduced driving after drinking as well as total drinks consumed before driving, text messaging may be highly effective when sent at the precise time that Airmen gain access to alcohol (the first time they are allowed off base), a standard time for all Technical Trainees.

One challenge to conducting alcohol research in the military is the lack of privileged communication. As a result, it is difficult to obtain valid self-reports due to a tendency to deny or minimize use. The investigators recently developed and validated a method for collecting anonymous data over time. This will be the first study in the military, as well as the first large scale, adequately powered trial, where intervention effects will be tracked out to a 6-month follow-up. The study's Specific Aims are to randomize approximately 3000 Airmen to either the current BAI versus the BAI+Text messages timed to occur before, during, and after Airmen have access to alcohol; and to evaluate the efficacy of the intervention at the end of training and 6 months post-training using repeated surveys with unique identifiers allowing researchers to match surveys while maintaining anonymity. conditions: Alcohol Drinking conditions: Binge Drinking conditions: Text Messaging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 3000 type: ESTIMATED name: Brief Alcohol Intervention name: Automated and Tailored Text Messages measure: AUDIT measure: Daily Drinking Questionnaire with NIAAA recommended assessment items sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: JBSA Lackland status: RECRUITING city: San Antonio state: Texas zip: 78236 country: United States name: Tina Boothe, MPH role: CONTACT email: tlb7aq@virginia.edu lat: 29.42412 lon: -98.49363 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-09-25 uploadDate: 2024-02-28T11:41 filename: ICF_000.pdf size: 160063 hasResults: False

 nctId: NCT06318962 id: UMemphis id: SPC-1000007404 GR127268 type: OTHER domain: Department of Defense briefTitle: Examining the Efficacy of a Digital Therapeutic to Prevent Suicidal Behaviors overallStatus: RECRUITING date: 2024-02-07 date: 2027-08-01 date: 2027-08-01 date: 2024-03-19 date: 2024-03-19 name: University of Memphis class: OTHER briefSummary: The primary aim of the project is to test the efficacy of BCBT delivered via a digital platform (i.e., smartphone) to Servicemembers with recent suicidal ideation and/or suicide attempts presenting to primary care clinics. Given existing challenges of scaling empirically-supported treatments/interventions for suicidality with fidelity, this project could lead to markedly expanded access to BCBT, along with improving our understanding about what intervention strategies are most effective and how they can be delivered with meaningful fidelity. Aviva, the digital version of BCBT, was developed for use with patients across the full spectrum of healthcare settings, including primary care. Aviva is not an emergency alert system, rather a digital platform for delivery of the full scope of BCBT treatment components. An open-label single group Phase I clinical trial has demonstrated the safety, tolerability, feasibility, fidelity, and potential efficacy of Aviva, with participants completing modules over 8 weeks, and follow-up assessments at weeks 1, 4, and 8. Subsequent refinements included the addition of technical features that would allow patients to revisit and/or repeat previously completed modules, along with integration of more characters for delivering video vignettes and greater opportunities for skills practice and treatment engagement. These modifications have further enhanced Aviva safety, tolerability, and fidelity, consistent with the original BCBT protocol. Not only is it hypothesized that Aviva will result in significantly larger reductions in severity of suicidal ideation than participants randomized to the control condition, but also that greater app engagement will be negatively correlated with severity of suicidal thinking. Moderators and mediators (i.e. suicidal beliefs, wish to live, impulsive decision-making) of intervention effects will also be examined. The study will be conducted at the primary care clinics at Fort Carson, with a goal of enrolling 720 patients across a two-year timeframe. Participants will be identified using each clinic's existing suicide risk assessment methods, including the PHQ-9 suicide risk item and a score of 1 or higher on the CSSRS Screener (Recent). Participants will be randomly assigned to one of two treatment conditions, Aviva or control (i.e., development of a safety plan consistent with local procedures and policies, along with referral for standard mental health care and suicide risk management in accordance with local policies and procedures). In an effort to address potential performance bias specific to smartphone use, participants in the control condition will download the Suicide Safety Plan app to their smartphones. Those in the Aviva condition will also complete weekly check-ins with Project 2 research clinicians to review treatment adherence, identify and respond to any logistical/operational problems, and respond to any unexpected emergencies and/or participant safety concerns. Participants will have up to five data points: baseline, 3, 6, 9, and 12 months. All data available from all participants and all time points will be included in the analyses, consistent with the intent-to-treat principle. Across our two previous clinical trials and our in-progress RCT, attrition during the first 12 months postbaseline was \&lt;30% and we anticipate similar rates in this trial. conditions: Suicidal Behaviors conditions: Suicide Ideation conditions: Depression/Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 400 type: ESTIMATED name: Aviva measure: Self Injurious Thoughts and Behaviors Interview Revised measure: Beck Scale for Suicide Ideation measure: Beck Hopelessness Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fort Carson status: RECRUITING city: Colorado Springs state: Colorado zip: 80829 country: United States name: Michelle Wine Chief Psychologist, Ph.D. role: CONTACT phone: 719-526-7461 email: michelle.d.wine.civ@health.mil name: Michelle Wine, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 38.83388 lon: -104.82136 hasResults: False

 nctId: NCT06318949 id: 87RI22_0007 (MALAHBAR) briefTitle: Albumin Modifications as Early Biomarkers of Chronic Liver Diseases acronym: MALAHBAR overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2029-06-01 date: 2029-12-01 date: 2024-03-19 date: 2024-03-19 name: University Hospital, Limoges class: OTHER briefSummary: Chronic liver diseases, affecting over 800 million people worldwide, lead to approximately 2 million annual deaths. The need for early, sensitive diagnostic strategies to prevent disease progression and reduce mortality is still unmet. The traditional serum markers lack sensitivity and specificity, leading to the integration of these biomarkers into panel tests with algorithms or imaging measures. Despite their widespread use, these tests have limitations at an individual level, including an inability to predict disease progression or response to treatment. To address these shortcomings, our project proposes utilizing albumin post-translational modifications (PTM) as a predictive biomarker for liver disease progression. The hypothesis is that albumin modifications occur in the early stages of hepatocellular damage and are indicative of future liver diseases. These modifications can be detected through serum albumin isoform determination, albumin isoforms profiles or the albumin's ligand-binding capacities. Innovatively, the study will use the Serum Enhanced Binding (SEB) test, which identifies reduced ligand-binding capacities, and discusses a second patent for determining a typical isoform profile based on the hepatic injury type.

Our preliminary results from animal models and a proof-of-concept studies with patients support this hypotheses. Our previous studies demonstrated also significant differences in albumin isoform profiles in response to different types of hepatic injury and high sensitivity and specificity in the SEB test among cirrhotic patients.

The primary objective of the MALAHBAR project is to evaluate the capacity of albumin PTM to predict liver disease progression over three years in chronic liver disease patients. Secondary objectives include assessing the predictive ability of different albumin isoforms and the SEB test for liver disease progression, evaluating diagnostic performances and confirming characteristic albumin isoform profiles related to specific hepatic injuries. The study could represent a significant advancement in liver disease diagnostics and management, offering new insights into the role of albumin in liver pathology. conditions: Chronic Liver Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective multicentre study of biomarker validation primaryPurpose: DIAGNOSTIC masking: NONE count: 756 type: ESTIMATED name: blood sampling measure: Ability of HSA PTM to predict the evolution of liver damage at 3 year in patients with an advanced chronic liver disease (ACLD) as recently defined in the BAVENO VII recommendations based on FibroScan. measure: ability of post-translational HSA modifications to predict the evolution of liver damage at 3 years based on liver-related events or on the worsening of the disease stage evaluated by the de Child Pugh or MELD score. measure: ability of the different isoforms of HSA to predict the evolution of liver damage at 1 and 2 years provided that data are available in the medical file. measure: ability of SEB test to predict the evolution of liver damage at 3 years (and at 1 and 2 years provided data are available in the medical file). measure: diagnostic performances of the SEB test and of the different isoforms of HSA at each stage of the liver disease. measure: confirm that the isoforms of HAS present in the characteristic patterns (type of isoform and intensity) of the nature of the liver damage. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Angers Univeristy Hospital city: Angers zip: 49100 country: France name: Jerome BOURSIER, MD role: CONTACT email: JeBoursier@chu-angers.fr name: Jerome BOURSIER, MD role: PRINCIPAL_INVESTIGATOR lat: 47.46667 lon: -0.55 facility: Limoges University Hospital city: Limoges zip: 87042 country: France name: Souleiman EL BALKHI, MD role: CONTACT email: Souleiman.ElBalkhi@chu-limoges.fr name: Paul CARRIER, MD role: CONTACT email: Paul.Carrier@chu-limoges.fr name: Paul CARRIER, MD role: PRINCIPAL_INVESTIGATOR lat: 45.83153 lon: 1.25781 facility: Poitiers University Hospital city: Poitiers zip: 86000 country: France name: Valentin ROLLE, MD role: CONTACT email: v.rolle@chu-poitiers.fr name: Valentin ROLLE, MD role: PRINCIPAL_INVESTIGATOR lat: 46.58333 lon: 0.33333 facility: Rennes University Hospital city: Rennes zip: 35000 country: France name: Florent ARTRU, MD role: CONTACT email: florent.artru@chu-rennes.fr name: Florent ARTRU, MD role: PRINCIPAL_INVESTIGATOR lat: 48.11198 lon: -1.67429 facility: Tours University Hospital city: Tours zip: 37170 country: France name: Laure ELKRIEF, MD role: CONTACT email: l.elkrief@chu-tours.fr name: Laure ELKRIEF, MD role: PRINCIPAL_INVESTIGATOR lat: 47.38333 lon: 0.68333 facility: Pointe à Pitre University Hospital city: Pointe-a-Pitre zip: 97159 country: Guadeloupe name: Moana GELU-SIMEON role: CONTACT email: moana.simeon@chu-guadeloupe.fr name: Moana GELU-SIMEON, MD role: PRINCIPAL_INVESTIGATOR lat: 16.24125 lon: -61.53614 hasResults: False

 nctId: NCT06318936 id: 22-677 briefTitle: Respiratory Syncytial Virus (RSV) Burden in Older Adults in Primary Care in The Netherlands acronym: RAPID overallStatus: RECRUITING date: 2022-11-01 date: 2024-05-01 date: 2024-05-01 date: 2024-03-19 date: 2024-03-19 name: UMC Utrecht class: OTHER name: Janssen-Cilag B.V. briefSummary: RSV infection is a leading cause of medical care in older adults, sometimes leading to hospital admission and severe outcomes. Although the majority of RSV infections are managed outside hospitals, little is known on the burden of RSV in older adults in the primary care setting. Accurate estimates of the RSV burden in primary care is particularly relevant since vaccines against RSV infection in older adults will likely become available for the general population soon. The use of high-quality point-of-care (POC) molecular viral diagnostics allows to identify RSV infected older adults and would therefore contribute to fill one of the most important gaps in knowledge facilitating implementation of RSV vaccination of older adults

With this prospective, observational study, we aim to define the disease burden of RSV infection in older adults in the primary care setting. conditions: RSV Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Burden of medically attended RSV infection in the Dutch primary care measure: RSV-related health care consumption and indirect costs in older adults measure: Proportion of medically attended RSV infection amongst all medically attended acute respiratory infections in older adults in the primary care setting measure: Association between disease severity and several clinical and demographic parameters (e.g. age, cardiopulmonary comorbidity, smoking status, chronic immunosuppressive medication use) and RSV burden (by disease severity and healthcare usage) measure: Incidence of RSV-related secondary bacterial pneumonia events and antibiotic use sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Utrecht status: RECRUITING city: Utrecht zip: 3584CX country: Netherlands name: Joanne Wildenbeest, MD, PhD role: CONTACT phone: 0031887563776 email: J.G.Wildenbeest@umcutrecht.nl lat: 52.09083 lon: 5.12222 hasResults: False

 nctId: NCT06318923 id: RC-P00117 briefTitle: Social and Moral Cognition in Multiple Sclerosis acronym: COSMOS overallStatus: RECRUITING date: 2023-12-19 date: 2025-04-30 date: 2025-10-30 date: 2024-03-19 date: 2024-03-20 name: Lille Catholic University class: OTHER briefSummary: Multiple Sclerosis (MS) is a chronic, progressive disease that affects young adults (aged between 20 and 40) and has a major impact on patients' quality of life. Cognitive disorders in MS are common, affecting 40-60% of patients. Among these disorders, the presence of social cognition disorders is common. Within social cognition, the moral judgment has been an object of research in order to understand the determinants of moral decision-making: how and why individuals make moral choices with regard to a set of prescriptions and social norms. Compared to control subjects, MS patients show a decrease in moral permissiveness, as well as an increase in moral relativity and emotional reactivity. Thus, it would seem that MS patients issue more deontological choices (lower moral permissiveness). Given that these patients also exhibit empathy deficits and higher alexithymia, these patterns are surprising. Indeed, in other clinical populations, low empathic abilities and high alexithymia are linked to utilitarian rather than deontological moral judgments.

The objective of this project is to analyze the process of decision-making carried out by patients during moral dilemma situations in comparison with control individuals and verify whether the presence of a positivity bias could explain the more deontological choices made by some patients. Indeed, some work has shown that older individuals make more deontological moral judgments than younger adults. These results are also observed with young individuals when their future temporal perspectives have been experimentally constrained. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 90 type: ESTIMATED name: Socio-demographic questionnaire, moral judgment task, cognitive tests, psychoaffective assessment name: MS questionnaire name: MONTREAL COGNITIVE ASSESSMENT (MoCA) test measure: Moral dilemma judgments measure: Explicit time perspective inventory test measure: Implicit time perspective inventory test measure: Dot Probe Task measure: Level of moral permissibility measure: Level of emotional reactivity measure: Moral relativity level measure: Brief International Cognitive Assessment for Multiple Sclerosis measure: The Beck Depression Inventory measure: State-Trait Anxiety Inventory measure: Toronto Alexithymia Scale (TAS)-20 measure: Empathy quotient-8 (EQ-8) measure: Electrodermal response sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Hôpital Saint-Vincent-de-Paul - Neurologie status: RECRUITING city: Lille country: France name: Béatrice DEGRAEVE role: CONTACT name: Laurent ZIKOS role: SUB_INVESTIGATOR lat: 50.63297 lon: 3.05858 facility: Hôpital Saint-Philibert - Neurologie status: RECRUITING city: Lomme country: France name: Béatrice DEGRAEVE role: CONTACT name: Laurent ZIKOS role: SUB_INVESTIGATOR lat: 50.64358 lon: 2.98715 hasResults: False

 nctId: NCT06318910 id: MU-SRF-RS-27 C/66 briefTitle: Customized Foot Orthoses on Muscle Activity During Standing and Gait in Plantar Heel Pain overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-11-30 date: 2024-12-31 date: 2024-03-19 date: 2024-03-19 name: Mahidol University class: OTHER briefSummary: The present study will use a randomized controlled trial (RCT) to determine the effectiveness of customized foot orthosis (CFO) for the treatment of patients with PHP. Three treatment groups including the CFO without wedge, the CFO with wedge type 1 (W1), and the CFO with wedge type 2 (W2) will be randomly assigned to each participant by a computer-generated randomization. The opaque-sealed envelopes will be used to allocate the groups of participant. conditions: Foot Orthoses conditions: Fasciitis, Plantar studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: The present study will use a randomized controlled trial (RCT) to determine the effectiveness of CFO for the treatment of patients with PHP. Three treatment groups including the CFO without wedge, the CFO with W1, and the CFO with W2 will be randomly assigned to each participant by a computer-generated randomization. The opaque-sealed envelopes will be used to allocate the groups of participant. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants will be allocated to the control (CFO without wedge) or experimental (CFO with W1 or W2) groups according to the seal-envelop randomization technique. Then, they will be assessed all outcomes for the baseline including pain intensity, foot function, lower-extremity muscle activity during gait and standing by the 2nd physical therapist. And the participants will receive the assigned treatment by the 1st physical therapist. whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: orthotic wedge name: CFO measure: Pain intensity and foot function measure: EMG of lower leg muscles measure: Subjective assessment measure: Physical assessment sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06318897 id: 2023-0645 id: NCI-2024-02384 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-09-30 date: 2025-09-30 date: 2027-09-30 date: 2024-03-19 date: 2024-03-19 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To look at the effectiveness of the combination of pembrolizumab, carboplatin, and paclitaxel in participants with stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer. conditions: Stage 1 cT1b-T1cN0M0 conditions: Triple Negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Carboplatin name: Paclitaxel name: Pembrolizumab name: Doxorubicin name: Cyclophosphamide measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Oluchi Oke, MD role: CONTACT phone: 832-729-8362 email: oukaegbu@mdanderson.org name: Oluchi Oke, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06318884 id: SCTB35-X101 briefTitle: A First-in-human Study of SCTB35 in Patients With Relapse/Refractory B-cell Non-Hodgkin Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-10 date: 2027-12 date: 2024-03-19 date: 2024-03-22 name: Sinocelltech Ltd. class: INDUSTRY briefSummary: This is a Phase I clinical study designed to evaluate the safety, tolerability, and pharmacokinetics, and preliminary efficacy of SCTB35 monotherapy, an bispecific antibody, in patients with relapsed and/or refractory B-cell non-Hodgkin lymphoma. conditions: Non-Hodgkin Lymphoma, B-cell studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 76 type: ESTIMATED name: SCTB35 injection measure: Dose-escalation part: dose limited toxicity (DLT) measure: Dose-escalation part: incidence rate of adverse event (AE) measure: Dose-expansion part: objective response rate (ORR) measure: Dose-escalation part: ORR measure: Dose-escalation part: CR rate (CRR) measure: Dose-escalation part: best of overall response (BOR) measure: Dose-escalation part: duration of response (DOR) measure: Dose-escalation part: progression-free survival (PFS) measure: Dose-escalation part: time to response (TTR) measure: Dose-escalation part: overall survival (OS) measure: Dose-escalation part: blood concentrations of SCTB35 measure: Dose-escalation part: anti-drug antibodies of SCTB35 measure: Dose-expansion part: CRR measure: Dose-expansion part: BOR measure: Dose-expansion part: DOR measure: Dose-expansion part: PFS measure: Dose-expansion part: TTR measure: Dose-expansion part: OS measure: Dose-expansion part: AE measure: Dose-expansion part: blood concentrations of SCTB35 measure: Dose-expansion part: anti-drug antibodies of SCTB35 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital city: Beijing state: Beijing zip: 100142 country: China name: Yuqin Song, M.D. role: CONTACT phone: 010-88196118 email: SongYQ_VIP@163.com lat: 39.9075 lon: 116.39723 facility: Henan Cancer Hospital city: Zhengzhou state: Henan country: China name: Keshu Zhou, M.D. role: CONTACT phone: 13674902391 email: dr_zkshu23810@163.com lat: 34.75778 lon: 113.64861 facility: Tianjin Medical University Cancer Institute & Hospital city: Tianjin state: Tianjin zip: 300060 country: China name: Lanfang Li, M.D. role: CONTACT phone: 18622221613 email: lilanfangmeng@163.com lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06318871 id: 23-688 briefTitle: A Phase 0 Pilot Study of Memory-like Natural Killer (NK) Cell Immune Therapy in Combination With N-803 in Patients With Renal Cell Carcinoma or Urothelial Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02-28 date: 2030-02-28 date: 2024-03-19 date: 2024-03-19 name: Dana-Farber Cancer Institute class: OTHER name: Kidney Cancer Association name: ImmunityBio, Inc. briefSummary: The goal of this research study is to establish the safety and then to explore the effectiveness of infusing the combination of cytokine-induced memory-like (CIML) natural killer (NK) cells, a type of immune cell in the blood that is collected and bathed in special proteins to help identify and treat curtained advanced cancers, combined with N-803, a medication that increases the activity of Interleukin-15, which is a cytokine that activates immune cells, in advanced clear cell renal cell carcinoma and urothelial carcinoma.

Names of the study therapies involved in this study are/is:

* CIML NK cell therapy (a NK cell therapy)
* N-803 (a type of recombinant human IL-15 superagonist) conditions: Renal Carcinoma conditions: Renal Cell Carcinoma conditions: Urothelial Carcinoma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: Cytokine Induced Memory-like Natural Killer (CIML NK) Cells name: N-803 measure: Feasibility Failure Rate (FFR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02215 country: United States name: Wenxin Xu, MD role: CONTACT phone: 617-632-6534 email: wenxin_xu1@dfci.harvard.edu name: Wenxin Xu, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Dana-Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States name: Wenxin Xu, MD role: CONTACT phone: 617-632-6534 email: Wenxin_Xu1@dfci.harvard.edu name: Wenxin Xu, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06318858 id: MU-CIRB 2022/313.1411 briefTitle: Daily and Weekly Iron Supplementation in Infants overallStatus: RECRUITING date: 2023-03-15 date: 2024-08-14 date: 2024-10-14 date: 2024-03-19 date: 2024-04-05 name: Mahidol University class: OTHER name: Suranaree University of Technology briefSummary: This study aims to compare the efficacy of daily iron supplementation and weekly iron supplementation in infants aged 6-12 months on the prevalence of anemia, hemoglobin level, and serum ferritin levels. Infants will be enrolled at 6 months and will be randomly assigned to receive either daily or weekly iron supplementation for the first 3 months and will be followed by weekly iron supplementation for another 3 months. conditions: Anemia conditions: Iron Status conditions: Infants conditions: Iron studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: group 1: daily iron syrup supplementation group 2: weekly iron syrup supplementation primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Letter codes were assigned to the iron syrup and the placebo by researchers who have not involved in the study. The codes have been kept until data analysis and report writing are complete. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: Iron supplement measure: Anemia status measure: Iron status measure: Weight measure: Length measure: Dietary intake measure: Head circumference (HC) measure: Hemoglobin typing measure: C-reactive protein (CRP) measure: Alpha-1 acid glycoprotein (AGP) measure: Serum transferrin receptor measure: Serum Retinol Binding Protein (RBP) sex: ALL minimumAge: 6 Months maximumAge: 12 Months stdAges: CHILD facility: Samphran District Hospital status: RECRUITING city: Sam Phran state: Nakhon Pathom zip: 73110 country: Thailand name: Tinnakorn Chuenchom, MD role: CONTACT phone: 6634311021 phoneExt: 105 name: Somchai Janelapwattanakul, MD role: CONTACT phone: 6634352052 phoneExt: 4001 lat: 13.72698 lon: 100.21526 hasResults: False

 nctId: NCT06318845 id: 2302CS-1 briefTitle: Phase 1 Study to Evaluate the Safety and Pharmacokinetic Drug Interaction of DHP2302R1 and DHP2302R2 overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-04 date: 2024-07-19 date: 2024-08-02 date: 2024-03-19 date: 2024-03-19 name: Daehwa Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to investigate the safety and drug interaction of DHP2302R1 and DHP2302R2 when administered alone versus in combination in healthy South Korean adult participants. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: NONE count: 42 type: ACTUAL name: DHP2302R1 name: DHP2302R2 measure: AUClast of DHP2302R1 and DHP2302R2 measure: Cmax of DHP2302R1 and DHP2302R2 measure: Tmax of DHP2302R1 and DHP2302R2 measure: AUC0-48 of DHP2302R1 and DHP2302R2 measure: AUCinf of DHP2302R1 and DHP2302R2 measure: t1/2 of DHP2302R1 and DHP2302R2 measure: CL/F of DHP2302R1 and DHP2302R2 measure: Vz/F of DHP2302R1 and DHP2302R2 sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: H Plus Yangji Hospital city: Seoul state: Gwanak-gu zip: 08779 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06318832 id: 124609 briefTitle: Optimizing a Wellbeing Program for Care-partners of Those With SCI overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-06 date: 2025-06 date: 2024-03-19 date: 2024-03-19 name: Lawson Health Research Institute class: OTHER briefSummary: Spinal cord injuries (SCI) have a devastating effect not only on individuals incurring the life changing event, but also on those who are involved in their care. Family care-partners of those with SCI (fcSCI) may experience significant negative effects including impaired mental health, high levels of burden, poor adjustment to role, decreased quality of life and strain on relationships. Cognitive behaviour therapy (CBT) is an evidence-based treatment strategy that helps individuals recognize and challenge their unhelpful thoughts and behaviours that contribute to their mental health concerns. However, barriers such as availability to specialized care, costs, rural and remote location, or concerns about stigma may limit access to care. Internet delivered CBT (ICBT) has the potential to reach a much wider group of people that may have unequal access to health care.

In a previous feasibility study, the team demonstrated the preliminary effectiveness of a tailored ICBT Wellbeing program for fcSCI. However, our understanding of which components of the program can result in optimal management is limited. The main purpose of this study is to evaluate the effectiveness of different components of the Wellbeing program including: therapist guidance, peer support groups, and booster sessions on symptoms of depression among fcSCI. The team will evaluate which intervention components result in meaningful improvement in symptoms of depression. Through collaborations with SCI community organizations and rehabilitation institutions, participants will be recruited across Canada. The researchers will also develop a model to examine the most cost-effective intervention package from the different components. The Wellbeing for fcSCI program can provide personalized service to individuals while being flexible and easily accessible, improving overall wellbeing and access to health care services. conditions: Internet-Delivered Cognitive Behavioural Therapy conditions: Depression conditions: Anxiety conditions: Spinal Cord Injuries conditions: Caregiver Burnout studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: NONE count: 154 type: ESTIMATED name: ICBT measure: Change in depression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06318819 id: 159-11-19. briefTitle: Plaque Removal Effectiveness of a Flossing Device Compared to the Conventional Flossing in Adults overallStatus: COMPLETED date: 2019-11-01 date: 2020-03-15 date: 2020-05-31 date: 2024-03-19 date: 2024-03-20 name: Maha A. Bahammam class: OTHER name: King Abdulaziz University briefSummary: * Objective: To evaluate the effectiveness in plaque removal of the new device; Dental floss holders and compare the results to the conventional way of flossing.
* Methods: Thirty adult male and female participants participated in this randomized, single-use, single-blind clinical study. Participants were randomly assigned to one of two groups; Group A: Consists of 30 participants in whom Dental Floss Holders (DFH) was constructed to either maxillary or mandibular arch randomly. Group B: Consists of 30 participants in whom conventional flossing (CF) was done to the other arch.

Participants attended the first visit for primary impression taking in order to construct the DFH. In the second visit, participants were examined by a blinded examiner to record their plaque index using O'Leary index. Then, they flossed using DFH and CF according to the group they were assigned to. Participants were monitored to ensure proper coverage of all the areas following precise instructions. They then brushed their teeth for approximately 2 minutes using modified bass technique. Next, plaque index was recorded again using the O'leary index. Time was recorded during flossing of each arch. Finally, participants were given a questionnaire to assess their satisfaction of the device.

* Results: The differences between the groups showed the DFH group with a 62.8% reduction in whole mouth plaque and 63.3% for proximal plaque compared to 52.9% and 50.4% for the CF group, respectively (p = 0.01). The DFH was more time efficient in removing plaque from the marginal regions with an average time of 00:00:37 in comparison to the CF which averaged in 00:02:07 (p \< 0.001). A total of 26 participants (86.7%) preferred using the DFH over the CF.
* Conclusion: With the combination of toothbrushing, the Dental Floss Holders is significantly more effective and time efficient than conventional flossing in removing plaque from tooth surfaces. conditions: Tooth Decay conditions: Cavities of Teeth conditions: Gingivitis conditions: Plaque studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Dental Floss Holders measure: Dental Floss Holders (DFH) measure: Conventional flossing (CF) sex: ALL minimumAge: 20 Years maximumAge: 26 Years stdAges: ADULT facility: King Abdulaziz University city: Jeddah country: Saudi Arabia lat: 21.54238 lon: 39.19797 hasResults: False

 nctId: NCT06318806 id: 2024-3633 briefTitle: Towards Remission and Full Recovery From Obsessive-compulsive Disorder acronym: RCT2023 overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2029-09-30 date: 2029-09-30 date: 2024-03-19 date: 2024-03-19 name: Ciusss de L'Est de l'Île de Montréal class: OTHER name: Canadian Institutes of Health Research (CIHR) briefSummary: Obsessive-compulsive disorder (OCD) is a disabling psychiatric illness that is characterized by distressing obsessional thoughts and time-consuming compulsive rituals. Exposure and Response Prevention (ERP) is a first-line psychological treatment of choice that requires patients to face their fears by being exposed to feared stimuli. This treatment has been shown to reduce symptoms in a significant proportion of patients. However, it is considered a difficult treatment and only a minority reach remission. Residual symptoms typically remain, or reappear after treatment, which is a risk for relapse. Inference-based Cognitive Behavioral Therapy (I-CBT) is a promising evidence-based treatment developed to overcome these limitations. I-CBT has already been found to be as effective as ERP and significantly more acceptable and easier to adhere to. There is also evidence that I-CBT is more effective for subgroups of patients. Consequently, the current research project is focused on improving treatments outcomes for those provide those who have previously unable to reach remission of their symptoms with ERP. Following an initial treatment with ERP, those that have been unable to reach remission, will be randomized to either I-CBT or more ERP. It is expected that I-CBT will be significantly more effective than providing patients with more of the same. In addition, the study aims to predict treatment outcome in order to be able to tell in advance which patients do not respond to ERP. The project is designed to maximize beneficial health outcomes with a stepped-care approach to treatment, but also to work towards a more personalized choice by being able to match patients in advance with the treatment that works best for them conditions: Obsessive-Compulsive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is a single site parallel-group randomized-controlled trial with an active run-in treatment. In the first phase of the trial, participants diagnosed with OCD will receive an active run-in treatment consisting of 18 sessions of ERP. In the second phase, non-remitters will be randomly allocated to another 18 sessions of I-CBT or continued treatment with ERP. Non-remission is operationalized in accordance with validated cut-off points established through international consensus and empirical findings (a score of \>12 on the YBOCS and a CGI-S rating of 3 or higher (mild to extremely ill) after the run-in treatment with ERP). I-CBT and continued ERP will be followed by a 6-month and 12-month follow-up conforming to current thinking on relapse and recovery in OCD. Treatments will be administered by trained therapists on a weekly one-on-one basis via videoconferencing for the duration of one hour. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: Psychological measure: Yale-Brown Obsessive-Compulsive Scale -2 (Y-BOCS-2) measure: Clinical Global Impression Scale (CGI) measure: Vancouver Obsessional Compulsive Inventory (VOCI) measure: Beck Depression Inventory (BDI) measure: Beck Anxiety Inventory (BAI) measure: Inferential Confusion Questionnaire (ICQ) measure: Dysfunctional Reasoning Processes Task (DRPT) measure: Fear of Self Questionnaire (FSQ-20) measure: Obsessive Beliefs Questionnaire (OBQ-20) measure: Brunnsviken Brief Quality of Life Scale (BBQ) measure: Sheehan Disability Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06318793 id: 2024Ao001* briefTitle: Preoperative Inflammatory Markers Predict Postoperative Complications After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Colorectal Carcinomatosis overallStatus: COMPLETED date: 2012-09 date: 2023-07 date: 2023-12 date: 2024-03-19 date: 2024-03-20 name: CHU de Reims class: OTHER briefSummary: A retrospective study of a single-center prospective database of patients who underwent curative CRS-HIPEC for peritoneal carcinomatosis (PC) of colo-rectal cancer (CRC), between September 2012 and July 2023 at Reims Hospital-University was conducted. Inclusion criteria were: patients older than 18 years with a performance status ≤ 2, who underwent complete (no macroscopic residual disease) CRS-HIPEC was performed. Exclusion criteria were the presence of an infectious disease prior to surgery, CRS without HIPEC, incomplete CRS and expressed refusal to participate in the study.

During the month prior to surgery, patients underwent a thorough diagnostic workup, including chest and abdominopelvic computed tomography (CT) scans, complete haematological and biochemical tests, and cytobacteriological analysis of urine. Blood tests included leukocytes, neutrophils, lymphocytes, platelet count, albumin and CRP. Within one week before surgery, patients were examined by both the surgeon and the anaesthetist.

Variables with a normal distribution are presented as mean-SD, while those with a non-normal distribution are presented as median and range. Categorical variables are presented as counts and percentages. Chi-Square or Fisher's exact test was used to compare qualitative variables. Linear regression analysis was used to assess any association between preoperative inflammatory biomarkers and patient comorbidities and disease characteristics. Preoperative levels of inflammatory biomarkers were compared between patients with no postoperative complication (POC) and patients with POC and major POC using the non-parametric Mann-Whitney U test. Optimal cut-off values for significant inflammatory biomarkers were determined using the Youden index. Receiver operating curves (ROC) were calculated to determine the area under the curve (AUC). Univariable and multivariable analyses including cut-off values of significant biomarkers were performed in a binary logistic regression analysis and expressed as odds ratios (OR). All tests were two-tailed and results were considered significant if the p-value was \< 0.05. Statistical analyses were performed using R software (version 4.0.5). conditions: Peritoneal Carcinomatosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 166 type: ACTUAL measure: Concentration of C-reactive protein (CRP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Reims city: Reims zip: 51092 country: France lat: 49.25 lon: 4.03333 hasResults: False

 nctId: NCT06318780 id: PI2023_843_0171 briefTitle: Concordance of Three Imaging Methods by Dynamic CT, Contrast Ultrasound and CT Angiography in the Characterization of Endoleaks in Patients With an Aortic Endoprosthesis acronym: LEAKDYN overallStatus: RECRUITING date: 2024-02-28 date: 2029-02 date: 2031-02 date: 2024-03-19 date: 2024-03-19 name: Centre Hospitalier Universitaire, Amiens class: OTHER briefSummary: Among patients who have undergone EVAR, there is a significant risk of 20-50% endoleak. These endoleaks often require secondary interventions to reduce the risk of expansion or rupture. Currently, three-phase CT angiography and CEUS ultrasound are recommended in the post-operative monitoring of EVAR but these remain limited in characterizing the type and source of endoleak. In this study the investigators will study the interest of d-CTA for a better detection and characterization of endoleaks. conditions: Aortic Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 69 type: ESTIMATED name: three-phase CT angiography name: CEUS ultrasound measure: Endoleak classification using the CT angiography measure: Variation of Endoleak classification between CEUS ultrasound and the CT angiography sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Amiens Picardie status: RECRUITING city: Amiens state: Picardie zip: 80054 country: France name: Thierry REIX, PhD role: CONTACT phone: +33322455929 email: reix.thierry@chu-amiens.fr lat: 49.9 lon: 2.3 hasResults: False

 nctId: NCT06318767 id: PI2023_843_0141 briefTitle: Predictive Value of Systolic Rise Time of the Plantar Arch on the Risk of Major Adverse Limb Events (MALE) and Major Adverse Cardiovascular Events (MACE) in Peripheral Artery Disease (PAD) at Critical Ischaemia Stage acronym: TAMIS overallStatus: RECRUITING date: 2024-03-04 date: 2025-03 date: 2025-09 date: 2024-03-19 date: 2024-03-19 name: Centre Hospitalier Universitaire, Amiens class: OTHER briefSummary: Peripheral artery disease (PAD), vascular disease of atheromatous origin, is a frequent pathology, with a steady and significant increase in prevalence over the last decades. It has various symptoms ranging from mild arterial claudication to critical limb ischemia. The critical ischaemia stage in PAD is defined by rest pain or trophic disorders and is a special situation because of the number of cardiovascular deaths at 1 year (25%), 60% at 5 years and acute ischaemic recurrence at 1 year (25%).

It is a medico-surgical pathology. A haemodynamic marker is needed to monitor patients, as it is predictive of limb progression, cardiovascular events and mortality. The Systolic Rise Time (SRT) of the plantar footpad is a recently described haemodynamic measurement of proven value in the diagnosis of PAD. The aim of this study is to show the prognostic value of the Systolic Rise Time on Major Adverse Limb Events (MALE). conditions: Major Adverse Limb Events conditions: Major Adverse Cardiovascular Events conditions: Peripheral Artery Disease conditions: Critical Limb Ischemia conditions: Hemodynamic Measure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 134 type: ESTIMATED name: hemodynamic measure of the Systolic Time Rise measure: occurrence of limb ischemia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Amiens status: RECRUITING city: Amiens zip: 80480 country: France name: SOUDET Simon, MD role: CONTACT phone: 03 22 88 72 89 email: soudet.simon@chu-amiens.fr lat: 49.9 lon: 2.3 hasResults: False

 nctId: NCT06318754 id: HP-00104241 briefTitle: Large-Bore Mechanic Thrombectomy for the Treatment of Symptomatic Portomesenteric Vein Thrombosis overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-09 date: 2026-06 date: 2024-03-19 date: 2024-03-19 name: University of Maryland, Baltimore class: OTHER name: Inari Medical briefSummary: A single site study evaluating the safety, feasibility, and effectiveness of percutaneous large-bore mechanical thrombectomy using the Inari Triever Aspiration Catheter for the treatment of portomesenteric vein thrombosis (PMVT). conditions: Thrombosis conditions: Thrombectomy conditions: Portal Vein studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10 type: ESTIMATED name: Inari Triever Aspiration Catheter measure: Technical Success measure: Clinical Success measure: Primary Patency measure: Intermediate functional success measure: Secondary Patency measure: Duration of hospitalization measure: Duration of ICU days measure: Blood loss during intervention measure: Transfusion measure: Major and minor complications measure: 30-day mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06318741 id: KayseriCHkinezyofobi briefTitle: Effects of Aerobic Exercise in Obese Patients With Atherosclerotic Cardiovascular Disease overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2024-09 date: 2024-03-19 date: 2024-03-19 name: Kayseri City Hospital class: OTHER_GOV briefSummary: Obesity is classified using body mass index (BMI) (BMI ≥25 overweight, BMI ≥30 obese, BMI ≥40 morbidly obese). Obese patients are Class 1 according to BMI; BMI:30-34.9 and Class 2; BMI: It is classified as 35-39.9. Patients with classes 1 and 2 will be included in the study. Obesity can be accompanied by comorbidities such as atherosclerotic vascular and cardiac pathologies, hyperlipidemia, hypertension, coronary artery disease, diabetes mellitus, so obesity treatment should be managed multidisciplinary. The basic approach to obesity treatment is diet, exercise, medical treatment, treatment of comorbid conditions and surgery. Aerobic exercise therapy, which is one of the conservative approaches in the treatment of obesity, also has an important place in the treatment of cardiovascular diseases associated with obesity. Atherosclerotic cardiovascular disease (AKD) is one of the most important causes of morbidity and mortality worldwide. Negative changes in functional capacity, quality of life and psychosocial situations are observed due to disorders associated with this disease. Physical activity is among the modifiable risk factors in atherosclerotic diseases. However, patients have a fear of movement related to angina-like symptoms, with the thought that the symptoms may recur during exercise. Lack of physical activity due to fear of movement leads to obesity, which in turn leads to aggravation of atherosclerosis and an increase in the incidence of cardiovascular events, which negatively affects individual and psychosocial capacity. Cardiopulmonary exercise test (CPET) is a non-invasive procedure that evaluates the individual's capacity during dynamic exercise and provides diagnostic and prognostic information. CPET is based on the investigation of the respiratory system, cardiovascular system and cellular response to exercise performed under controlled metabolic conditions. It allows holistic evaluation of the response to exercise, including not only the pulmonary and cardiovascular systems but also the musculoskeletal system. Fear of movement or kinesiophobia; It is defined as a state of fear and avoidance of activity and physical movement resulting from the feeling of sensitivity to painful injury and repeated injury. conditions: Obesity conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: aerobic exercise on the treadmill+For both groups, patients will be recommended joint range of motion (ROM), stretching, strengthening, posture and balance and flexibility exercises for all joints. name: Walking at an intensity of 12-13 RPE+For both groups, patients will be recommended ROM, stretching, strengthening, posture and balance and flexibility exercises for all joints. measure: Tampa Kinesiophobia Scale measure: Cardiopulmonary exercise test measure: 6 Minutes Walking Test measure: Body anthropometric measurements measure: Hospital anxiety and depression scale measure: international physical activity score measure: MacNew Heart Disease Health-Related Quality of Life Survey measure: Numerical Rating Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital city: Kayseri zip: 38080 country: Turkey lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06318728 id: CAEE - 70162723.0.0000.8093 briefTitle: Musculotendinous Adaptations in High and Low- Performance Triathletes acronym: MAT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-07-16 date: 2024-10-04 date: 2024-03-19 date: 2024-03-19 name: University of Brasilia class: OTHER briefSummary: This study aims to investigate the musculotendinous adaptations in the Achilles tendon and the muscles composing the triceps surae induced by triathlon training and competitions in high-performance and low-performance athletes. Twenty high-performance triathletes, twenty low-performance triathletes, and twenty physically active and healthy individuals of both genders will be recruited to constitute the research groups. Ultrasonography will be employed as the assessment method for the structures of the Achilles tendon and the muscular architecture of the triceps surae. The quality and portability of ultrasonography, coupled with its real-time information capabilities, make it the appropriate choice for this evaluation. The VISA-A scale (Victorian Institute of Sport Achilles Assessment) will be used to measure pain and function of the Achilles tendon. The reliability of ultrasonography measures will be obtained by evaluating images of individuals using the intraclass correlation coefficient, allowing for the analysis of result reproducibility. Data analysis will involve comparisons among the high-performance, low-performance, and physically active groups, aiming to identify differences in musculotendinous adaptations related to performance and injury predisposition. Structural changes occurring in these structures and their potential association with sports performance and/or injury predisposition will be explored. Overall, this study utilizes a comparative cross-sectional research design, where different groups are assessed regarding musculotendinous adaptations in the Achilles tendon and triceps surae through ultrasound-derived measures. The use of the VISA-A scale and the assessment of measure reliability will provide additional data on pain, function, and result reproducibility. conditions: Athletes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: Morphological Properties: Tendon Length (TL). measure: Evaluation of Achilles Tendon Shape (fusiform or parallel) measure: Echogenicity of the Tendon (homogeneous and heterogeneous areas) measure: Mechanical properties of the Achilles Tendon: Force measure: Mechanical properties of the Achilles Tendon: Stress measure: Mechanical properties of the Achilles Tendon: Strain measure: Material Properties of the Achilles Tendon: Elastic Modulus measure: Muscle Thickness measure: Muscle Properties: Pennation Angle (PA) measure: Muscle Properties: Fascicle Length (FL) measure: Muscle Echogenicity measure: Assessment of Muscle Electrical Activation measure: Muscle Torque Evaluation measure: Evaluation of Muscle and Achilles Tendon Stiffness through 2D Shear Wave Elastography (SWE): measure: Ankle pain and function sex: ALL minimumAge: 17 Years maximumAge: 52 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06318715 id: 23-0009-A briefTitle: Modified Deep Extubation vs. Standard Awake Extubation acronym: mDE overallStatus: RECRUITING date: 2024-04-03 date: 2024-12 date: 2025-03 date: 2024-03-19 date: 2024-04-18 name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital class: OTHER briefSummary: The proposed study is to compare a modified DE technique, which is regularly used for low-risk patients by staff anesthesiologists at our institution, to a standard awake extubation. This modified deep extubation (mDE) occurs while the patient is still anaesthetized but at a lower dose of anaesthetic gas than previously described, and balanced with long acting opioids to attenuate the airway reaction. As previously stated, the literature shows that the risks of DE are equivalent to those of regular AE practice. Our hypothesis is that mDE will shorten the time from the end of the surgery (completion of last stitch) to the moment the patient is ready to leave the OR by at least 5 minutes when compared to standard AE practice. conditions: Extubation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: modified deep extubation (mDE) name: standard awake extubation measure: Time from the end of the surgery to leaving the OR measure: Time from the end of the surgery to extubation measure: Time from the end of the surgery to discharge from PACU measure: oral airway measure: jaw-thrust maneuver measure: hypertension measure: breath holding measure: bag-mask ventilation measure: coughing measure: bucking measure: laryngospasm measure: treat laryngospasm measure: desaturation measure: reintubation measure: Patient's experience measure: BP measure: HR measure: EtCO2 measure: SaO2 measure: Sevorane MAC sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Anesthesia Mount Sinai Hospital status: RECRUITING city: Toronto state: Ontario zip: M5G 1X5 country: Canada name: Naveed Siddiqui, MD role: CONTACT phone: 416-586-4800 phoneExt: 5270 email: naveed.siddiqui@uhn.on.ca name: Naveed Siddiqui, MD role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06318702 id: 2023-KAEK-180 briefTitle: The Effect of Constructivist Learning Model Based Gynecological Cancer Education overallStatus: COMPLETED date: 2023-12-25 date: 2024-01-20 date: 2024-02-20 date: 2024-03-19 date: 2024-03-20 name: Kastamonu University class: OTHER briefSummary: This is a randomised controlled study.The study was conducted to determine the effect of the constructivist education model given to women on gynecological cancer awareness, health Anxiety and spiritual well-being in women . The study population was composed of women living in Kastamonu. Women will be assigned to control and experimental groups. Women in the control group will receive gynecological education from Cancer Early Diagnosis, Screening and Education Centers (KETEM). The other group will receive gynecological cancer education based on the constructivist model.The hypotheses of the study are as follows:

H0: The of constructivist learning model -based health education programme does not have an effect on gynecologic cancer awareness, spiritual well-being and health anxiety.

H1: The of constructivist learning model -based health education programme have an effect on gynecologic cancer awareness, spiritual well-being and health anxiety. conditions: Gynecologic Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 107 type: ACTUAL name: Education measure: gynecologic cancer awareness measure: spiritual well-being measure: health anxiety scores sex: FEMALE minimumAge: 18 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kastamonu University city: Merkez state: Kastamonu zip: 37150 country: Turkey hasResults: False

 nctId: NCT06318689 id: 2023/0211/OB briefTitle: In Situ Exploration of Vascular Function in Vasoplegic Shock Following Cardiac Surgery With Cardiopulmonary Bypass acronym: Vaso-shock overallStatus: RECRUITING date: 2024-02-05 date: 2026-02-05 date: 2026-05-05 date: 2024-03-19 date: 2024-03-19 name: University Hospital, Rouen class: OTHER briefSummary: The goal of this observational study is to assess in situ vascular function, glycocalyx and microcirculation in postoperative vasoplegic shock following cardiac surgery with cardiopulmonary bypass.

The main question is to investigate the relationship between NO-dependent vasomotor reserve and the presence of vasoplegic shock following cardiac surgery with cardiopulmonary bypass.

Participants will have two visits, during which a number of non-invasive examinations will be carried out to study glycocalyx, microcirculation and vascular function. Biological and morphological data will be collected up to 3 months after inclusion, as well as information on treatments administered and outcome.

Researchers will compare a group of patients with vasoplegic shock against a group without vasoplegic shock in order to study possible alterations in function in the vasoplegic shock group. conditions: Cardiac Surgical Procedures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 124 type: ESTIMATED measure: Association between the percentage of brachial artery variation measured by the flow-mediated vasodilation method and the presence of vasoplegic shock at incusion. measure: Association between the percentage of brachial artery variation measured by the flow-mediated vasodilation method and the presence of vasoplegic shock at 48 hours. measure: Pefused boundary region (PBR, µm) obtained from Glycocheck with the presence of vasoplegic shock. measure: Microvascular blood flow (10^3 microns^3 / sec / mm^2) obtained from Glycocheck with the presence of vasoplegic shock measure: Total density (number of 10 micron long vessel segments with diameter of 4 to 25 microns per tissue surface area /mm^2) obtained from Glycocheck with the presence of vasoplegic shock measure: Endothelial function markers (Endothelin-1, pg/mL) with the presence of vasoplegic shock measure: Endothelial function markers (syndecan-1, pg/mL) with the presence of vasoplegic shock measure: Endothelial function markers (interleukin-6, pg/mL) with the presence of vasoplegic shock measure: Endothelial function markers (VCAM-1, pg/mL) with the presence of vasoplegic shock measure: Multivariate analysis explaining the occurrence of vasoplegic shock. measure: Multivariate analysis explaining the occurrence of an altered perfused boundary region (µm). sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rouen University Hospital status: RECRUITING city: Rouen state: Normandie zip: 76000 country: France name: Emmanuel Besnier, MD, PhD role: CONTACT phone: 33232881705 email: emmanuel.besnier@chu-rouen.fr name: Domitille Renard, MD role: CONTACT phone: 33232881705 email: domitille.renard@chu-rouen.fr lat: 49.44313 lon: 1.09932 hasResults: False

 nctId: NCT06318676 id: CA057-1009 briefTitle: A Study to Evaluate the Drug Levels of Mezigdomide in Adult Participants With Renal Impairment overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-03-05 date: 2025-03-05 date: 2024-03-19 date: 2024-03-19 name: Celgene class: INDUSTRY briefSummary: The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment. conditions: Renal Impairment studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Mezigdomide measure: Maximum observed concentration (Cmax) measure: Area under the plasma concentration-time curve (AUC) measure: Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) measure: Number of participants with adverse events (AEs) measure: Number of participants with serious adverse events (SAEs) measure: Number of participants with physical examination findings measure: Number of participants with vital sign abnormalities measure: Number of participants with 12-lead electrocardiogram (ECG) findings measure: Maximum observed concentration (Cmax) measure: Time of maximum observed concentration (Tmax) measure: Area under the plasma concentration-time curve (AUC) sex: ALL minimumAge: 18 Years maximumAge: 82 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PANAX city: Miami Lakes state: Florida zip: 33014 country: United States name: Robert Perry, Site 0002 role: CONTACT phone: 3056984500107 lat: 25.90871 lon: -80.30866 facility: Local Institution - 0003 city: Orlando state: Florida zip: 32808 country: United States name: Site 0003 role: CONTACT lat: 28.53834 lon: -81.37924 facility: Orlando Clinical Research Center OCRC city: Orlando state: Florida zip: 32809 country: United States name: Thomas Marbury, Site 0001 role: CONTACT phone: 407-257-3462 lat: 28.53834 lon: -81.37924 hasResults: False

 nctId: NCT06318663 id: STUDY00007685 briefTitle: Survivor Mom Companion Comparison Study acronym: SMC overallStatus: RECRUITING date: 2023-12-12 date: 2024-12-12 date: 2024-12-12 date: 2024-03-19 date: 2024-03-20 name: State University of New York at Buffalo class: OTHER briefSummary: The overall goal of the SMC is to help reduce posttraumatic stress symptomology for pregnant persons with a history of trauma. conditions: Posttraumatic Stress Symptom studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Survivor Mom Companion measure: Childhood Trauma Questionnaire measure: Primary Care Post Traumatic Stress Disorder Screen for Diagnostic and Statistical Manual of Mental Disorders-5 measure: Adverse Childhood Experiences Questionnaire measure: Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders measure: Dissociative Subtype of Post Traumatic Stress Scale measure: Patient Health Questionnaire-9 measure: State Trait Anger Expression Inventory measure: Symptoms Checklist-90 Revised/Interpersonal Sensitivity Subscale measure: Difficulties in Emotion Regulation Scale Short Form sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Buffalo Prenatal-Perinatal Network status: RECRUITING city: Buffalo state: New York zip: 14203 country: United States name: LuAnne Brown role: CONTACT email: lb@bppn.org lat: 42.88645 lon: -78.87837 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-08-28 uploadDate: 2024-03-15T14:52 filename: Prot_SAP_000.pdf size: 217043 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-08-28 uploadDate: 2024-03-15T14:53 filename: ICF_001.pdf size: 270737 hasResults: False

 nctId: NCT06318650 id: 19124PER6_3_1 briefTitle: Post Extraction Changes After Ridge Preservation Using Allogeneic Dentin Matrix Vs Demineralized Freeze Dried Allograft overallStatus: RECRUITING date: 2024-02-01 date: 2024-06-01 date: 2024-12-01 date: 2024-03-19 date: 2024-03-19 name: Cairo University class: OTHER briefSummary: the aim of this study is to establish if there are clinical, radio-graphical and histomorphometrical differences between using Allogenic Demineralized Dentin matrix versus Demineralized Freeze-Dried Bone Allograft (DFDBA) as a clinical application in alveolar bone regeneration procedures related to implant dentistry, including socket preservation, alveolar ridge augmentation, after tooth extraction in the esthetic zone.Will ridge preservation using Allogeneic Dentin Matrix be more effective than Demineralized Freeze-Dried Bone Allograft in managing the post extraction hard tissue alterations?

The initial therapy consists of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed, adjustment of faulty restoration and polishing. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques. alginate impression will be taken to fabricate an acrylic stent to be used as reference for measurements of width of ridge clinically.

Flapless and atraumatic tooth extraction will be initiated, Then the socket will be filled either with Allogeneic Dentin Matrix or Demineralized freeze-dried bone allograft (DFDBA) up to the crestal level of then bone followed by placement of a collagen membrane to cover the socket. criss-cross horizontal mattress suturing technique

Intervention group: The socket will be filled with Allogeneic Dentin Matrix Control group: The socket will be filled with Demineralized freeze-dried bone allograft (DFDBA).

For both groups, All the subjects will be evaluated at pre-surgical, baseline and 6 months post surgical months for clinical parameters and baseline( immediate post-surgical and 6 months post-surgical . Outcomes: Change in ridge width clinically after 6 months, Change in the radiographic buccal vertical bone level, Change in the radiographic palatal vertical bone level,Change in the radiographic horizontal bone level,Percentage of new vital bone formation,Percentage of residual bone graft and Implant Primary Stability. conditions: Socket Preservation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Randomized Controlled Clinical Trial primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 22 type: ESTIMATED name: Demineralized Dentin Matrix name: Demineralized freeze-dried bone allograft (DFDBA) measure: Change in Ridge width over 6 months measure: Change in the radiographic vertical bone level measure: Change in the radiographic horizontal bone level measure: Percentage of new vital bone formation and residual graft measure: Implant Primary Stability sex: ALL minimumAge: 20 Years maximumAge: 55 Years stdAges: ADULT facility: Faculty of Dentistry Cairo University status: RECRUITING city: Cairo zip: 12613 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06318637 id: CCSSKB005432 briefTitle: A Study to Evaluate the Acceptability and Feasibility of a Bedtime Routine for Neonates overallStatus: NOT_YET_RECRUITING date: 2024-03-21 date: 2024-12-23 date: 2024-12-23 date: 2024-03-19 date: 2024-03-19 name: Johnson & Johnson Consumer Inc. (J&JCI) class: INDUSTRY briefSummary: The purpose of this study is to assess, via caregiver questionnaire, the acceptability and feasibility of implementing a bedtime routine for newborns. conditions: Newborn studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 100 type: ESTIMATED name: Baby Wash/Shampoo name: Daily Activities name: Body Lotion measure: Bedtime Routine Acceptability and Feasibility to Caregivers measure: Bedtime Routine Acceptability and Feasibility to Caregivers measure: Bedtime Routine Acceptability and Feasibility to Caregivers measure: Bedtime Routine Acceptability and Feasibility to Caregivers sex: ALL minimumAge: 2 Weeks stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: SGS North America, Inc. city: Richardson state: Texas zip: 75081 country: United States lat: 32.94818 lon: -96.72972 hasResults: False

 nctId: NCT06318624 id: KHSU-2023/11 briefTitle: Immediate Effects of Ankle MWM and Taping on Gait and Balance in Stroke Patients overallStatus: RECRUITING date: 2024-02-14 date: 2024-09-15 date: 2024-10-11 date: 2024-03-19 date: 2024-03-19 name: Kutahya Health Sciences University class: OTHER briefSummary: Disorders caused by stroke may lead to significant limitations, especially in ankle range of motion, and may cause impairments in walking and balance functions. This limitation in ankle range of motion leads to difficulties in weight transfer, stability, and balance. As a result, there is a decrease in walking performance and an increased risk of falls. Various interventions have been used to improve ankle dorsiflexion passive range of motion, including gastrosoleus muscle stretching, muscle strengthening training, functional electrical stimulation training, proprioceptive control training, taping, manual therapy, different mobilization techniques, and ankle mobilization with motion (MWM).There are limited studies investigating the immediate effects of MWM and taping on gait and balance in stroke patients. This study was planned to investigate the effect of Mulligan's ankle MWM technique and talus stabilization taping on spatiotemporal gait and balance parameters in stroke patients. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: There are 2 different groups in the study. One of them is the intervention group and the other is the sham group. whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Mobilisation with Movement and Taping name: Sham measure: Stride length measure: Stride width measure: Cadance measure: Walking speed measure: The symmetry of the center of pressure changes during walking measure: The maximum force on the feet during walking measure: The distribution of pressure on the feet measure: Balance measure: 10-meter walk test measure: Timed up and go test sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kutahya Health Sciences University status: RECRUITING city: Kütahya zip: 43100 country: Turkey name: Fatıma Yaman, PhD, MD role: CONTACT phone: +905066802926 email: fatimacakir84@hotmail.com name: Berna Kılıç, PT role: SUB_INVESTIGATOR lat: 39.42417 lon: 29.98333 hasResults: False

 nctId: NCT06318611 id: 09.2022.575 briefTitle: Sleep Patterns and Chronotype in Children With and Without Type 1 Diabetes overallStatus: COMPLETED date: 2022-05-01 date: 2023-05-01 date: 2023-05-01 date: 2024-03-19 date: 2024-03-19 name: Koç University class: OTHER name: Marmara University briefSummary: Type 1 diabetes (T1D) is one of the most common chronic childhood diseases. Recent studies have highlighted the strong association between type 1 diabetes and sleep health problems. Sleep problems have been reported to include sleep onset, sleep maintenance, frequent nighttime awakenings, and daytime sleepiness. Studies show that children with T1D sleep significantly less than their peers without diabetes, and that this is associated with poorer glycemic control in type 1 diabetes due to impaired glucose metabolism.

This study aimed to compare sleep health composite dimensions and chronotype in children and adolescents with and without T1D, and to explore the relationship between sleep and glycemic variability in T1D.

The study was designed as a prospective observational case-control study. The estimated sample size is calculated as 168.

The sleep health composite dimensions were measured using actigraphy, sleep diaries, and self- or parental reports. Sleep disturbance will be assessed using the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) Level 2-Sleep Disturbance Scale Short Form, and the Children's Chronotype Questionnaire will be used to determine the chronotype. Sleep/wake patterns were also assessed using sleep diaries. Glycemic variability was assessed using continuous glucose monitoring (CGM) device parameters. conditions: Type1diabetes conditions: Sleep conditions: Chronotype studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 168 type: ACTUAL name: sleep, chronotype measure: Sleep health composite measure: Chronotype measure: Glycemic variability measure: Glycemic control sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Necla İpar city: İstanbul zip: 34010 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06318598 id: 23M202 briefTitle: Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis acronym: DRIVEALS overallStatus: RECRUITING date: 2023-04-11 date: 2026-04-10 date: 2026-04-10 date: 2024-03-19 date: 2024-03-19 name: Istituto Auxologico Italiano class: OTHER name: Azienda Ospedaliera Città della Salute e della Scienza di Torino name: Ospedale San Raffaele briefSummary: The goal of this observational study is to understand the clinical variability in a population of ALS patients using multidimensional biomarkers. The main questions it aims to answer are:

* Which set of biomarkers explain genotypic-phenotypic correlations in ALS?
* Which set of biomarkers can be used to subdivide the ALS population in homogeneous subgroups?

Participants will undergo:

* neurological evaluation
* neurophysiological evaluation
* neuropsychological evaluation
* whole exome sequencing
* biomarker measurement in CSF and plasma conditions: Amyotrophic Lateral Sclerosis conditions: Motor Neuron Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: genetic screening measure: biomarker assessment measure: clinical assessment measure: neuropsychological assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale San Raffaele status: RECRUITING city: Milano state: MI zip: 20132 country: Italy name: Yuri Falzone, MD, PhD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Ospedale San Luca status: RECRUITING city: Milano state: MI zip: 20149 country: Italy name: Alberto Doretti, MD role: CONTACT phone: +0261911 phoneExt: 2937 email: a.doretti@auxologico.it lat: 45.46427 lon: 9.18951 facility: AOU Città della Salute e della Scienza status: RECRUITING city: Torino state: TO zip: 10126 country: Italy name: Adriano Chiò, MD role: CONTACT lat: 45.07049 lon: 7.68682 hasResults: False

 nctId: NCT06318585 id: 23C306 briefTitle: Creation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases acronym: ALS-PHENO overallStatus: RECRUITING date: 2023-04-03 date: 2026-12-31 date: 2026-12-31 date: 2024-03-19 date: 2024-03-19 name: Istituto Auxologico Italiano class: OTHER briefSummary: Study Description: Characterization of Motor Neuron Disease Phenotypes

The goal of this observational study is to understand the clinical presentation of motor neuron disease (MND) in patients attending the Neurology Department of the Istituto Auxologico Italiano. The main questions it aims to answer are:

* What are the specific clinical phenotypes associated with MND?
* How can these phenotypes contribute to a better understanding of the disease's underlying mechanisms and improve prognostic accuracy?

Participants will undergo:

* Clinical evaluation using validated scales
* Neurophysiological and neuroradiological instrumental assessment
* Neuropsychological evaluation
* Collection of biological materials for genetic screening and biomarker assessment, if necessary. conditions: Amyotrophic Lateral Sclerosis conditions: Motor Neuron Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: no. of patients with classic ALS measure: no. of patients with bulbar ALS measure: no. of patients with LMN phenotypes (flail arm, flail leg, PMA) measure: no. of patients with UMN phenotypes (pyramidal ALS, PLS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale San Luca status: RECRUITING city: Milano state: MI zip: 20149 country: Italy name: Alberto Doretti, MD role: CONTACT phone: +0261911 phoneExt: 2937 email: a.doretti@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06318572 id: PR(AG)166/2021 briefTitle: Development of Self-administrable Psychological Intervention Programs Supported by New Technologies as a Treatment for Patients With Functional Digestive Disorders. overallStatus: RECRUITING date: 2023-03-09 date: 2024-12-30 date: 2025-04-30 date: 2024-03-19 date: 2024-03-19 name: Hospital Universitari Vall d'Hebron Research Institute class: OTHER briefSummary: Disorders of gut-brain interaction (DGBI) are produced by disturbances in the interplay between the gut and the central nervous system. Several psychological factors like anxiety, depression and altered coping are over-represented in these disorders. Recent surveys have shown that DGBI affect up to 40 % of the general population.

Psychological interventions like cognitive behavioral therapy and hypnosis have been shown to be beneficial for managing these disorders. However, access to psychological interventions is very limited due to lack of resources to treat these very frequent conditions.

OBJECTIVE: To determine the effects of psychological interventions using specifically developed therapeutic programs based on virtual reality, for telematic use at home, on symptoms severity, comorbidities, visceral sensitivity and intestinal dysbiosis in patients with DGBI.

METHODOLOGY: After development of a program of psycho-education on DGBI using interactive immersion by means of virtual reality (VR) a randomized clinical trial will be developed. Consecutive patients will be randomized 1:1 to active treatment or placebo. In each patient in the active treatment group a session of psychoeducation using specifically developed VR-video leaded by a gastroenterologists, will be followed by telematic weekly group sessions of psycho-education leaded by a psychologist. During the 6 weeks of the treatment period patients will be instructed to perform self-administrable sessions of psychotherapy at home (by means VR). Patients in the placebo group willl take a placebo capsule daily.

OUTCOME MEASURES. In all patients, severity of symptoms (primary outcome), QoL, somatic and psychological comorbidities (using specific questionnaires), visceral sensitivity (by means of a barostat) and microbiota analysis, will be performed before and at the end of the treatment period. Symptom severity will be assess also in follow-up phone calls at 3 and 6 months. conditions: Irritable Bowel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Psychological intervention name: Placebo measure: Severity of abdominal symptoms measure: IBS related Quality of life measure: Stress measure: Anxiety and depression measure: Somatic co-morbidities measure: Rectal sensitivity measure: Analysis of gut microbiota composition sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitari Vall d'Hebron status: RECRUITING city: Barcelona zip: 08035 country: Spain name: Jordi Serra, MD role: CONTACT phone: 34 932746259 email: jordi.serra@vallhebron.cat role: CONTACT email: jordi.serra@vallhebron.cat lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06318559 id: 027-FPO22 briefTitle: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention acronym: RIDERS overallStatus: RECRUITING date: 2022-06-29 date: 2025-12-31 date: 2027-12-31 date: 2024-03-19 date: 2024-03-19 name: Fondazione del Piemonte per l'Oncologia class: OTHER name: San Luigi Gonzaga Hospital briefSummary: This is a prospective randomized multicenter study aimed at comparing 3D AI-AR-RARP vs. no 3D, verifying the impact of this new technology on oncological and functional outcomes after the procedure. conditions: Cancer of Prostate studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomized using an Excel® macro in 2 group: 3D and no3D, stratifying them by age, PSA, cT, PSA density, prostate volume, lesion volume, extracapsular extension (ECE), seminal vesicle invasion (SVI), biopsy ISUP. primaryPurpose: DIAGNOSTIC masking: NONE count: 120 type: ESTIMATED name: 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy measure: Perioperative surgical oncological outcomes measure: Micturition outcomes measure: Sexual function outcomes measure: Oncological outcomes measure: Verify the potential application of AI sex: MALE minimumAge: 40 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo status: RECRUITING city: Candiolo state: Turin zip: 10060 country: Italy name: Enrico Checcucci, MD role: CONTACT phone: +390119933632 email: enrico.checcucci@ircc.it lat: 44.95858 lon: 7.59812 facility: AOU san Luigi Gonzaga status: RECRUITING city: Orbassano state: Turin zip: 10060 country: Italy name: Francesco Porpiglia, MD role: CONTACT lat: 45.00547 lon: 7.53813 hasResults: False

 nctId: NCT06318546 id: FMASU MS59/2024 briefTitle: Dexmedetomidine in Spinal Anesthesia Decreasing Post Spinal Shivering in Caesarean Section overallStatus: NOT_YET_RECRUITING date: 2024-04-03 date: 2024-10 date: 2024-11 date: 2024-03-19 date: 2024-04-01 name: Ain Shams University class: OTHER briefSummary: The investigators will test the effects of intrathecal dexmedetomidine as adjuvant to intrathecal bupivacaine and it's direct effect in decreasing incidence of post spinal shivering in Parturients Undergoing Caesarean section conditions: Post Spinal Shivering studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Dexmedetomidine Injection [Precedex],,, name: Fentanyl measure: Post spinal shivering sex: FEMALE minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06318533 id: 2023-11-01 briefTitle: A Clinical Study of CD19 CAR NK Cells for the Treatment of Relapsed/Refractory B-cell Related Autoimmune Diseases overallStatus: RECRUITING date: 2024-03-13 date: 2025-03-13 date: 2026-03-13 date: 2024-03-19 date: 2024-03-25 name: YANRU WANG class: OTHER name: Rui Therapeutics Co., Ltd briefSummary: A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cells (KN5501) in patients with relapsed/refractory B-cell related autoimmune diseases.15 patients are planned to be enrolled in the dose-escalation trial (6×10\^9 cells, 9×10\^9 cells). The primary objective of the study is to evaluation of the safety and feasibility of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The secondary objective is to evaluate the effectiveness of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The exploratory objective is to evaluate expansion, persistence and ability to deplete CD19 positive B cells of KN5501 in patients with relapsed/refractory B-cell related autoimmune diseases. conditions: Autoimmune Diseases studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: anti-CD19 CAR NK cells measure: Incidence of Dose Limiting Toxicity (DLTs) measure: Treatment Emergent Adverse Events（TEAEs） measure: Disease control rate of subjects measure: Remission rate of subjects sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Hospital of Jiangsu University status: RECRUITING city: Zhenjiang state: Jiangsu zip: 212001 country: China name: Yu Tang role: CONTACT phone: 086-13815153350 email: tangtang@ujs.edu name: Yu Tang, Dr. role: PRINCIPAL_INVESTIGATOR lat: 32.21086 lon: 119.45508 facility: Jiangsu University Affiliated Hospital status: RECRUITING city: Zhenjiang state: Jiangsu zip: 212001 country: China name: Yanru Wang role: CONTACT phone: 0511-85026079 email: tangtang@ujs.edu name: Yu Tang, Doctor role: PRINCIPAL_INVESTIGATOR lat: 32.21086 lon: 119.45508 hasResults: False

 nctId: NCT06318520 id: AFSU-DHF-TOPAL-001 briefTitle: Clinical Success of Stainless Steel Crowns Applied Using Different Cements overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-05-01 date: 2024-03-19 date: 2024-03-20 name: Afyonkarahisar Health Sciences University class: OTHER briefSummary: The main question of the study was to evaluate the one-year clinical success of SSc bonded with two different cement types in MIH teeth with excessive material loss. The researchears will compare the survival rate, effect on gingival health and radiographic success of calcium silicate-based resin-containing cement and resin-modified glass ionomer cement. conditions: Dental Enamel Hypomineralization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Use of Calcium silicate based resin cement and resin modified glass ionomer cement measure: Anatomical Integrity measure: Marginal Compliance measure: Proximal Contact measure: Crown Marginal Location measure: Restoration success measure: Green and Vermillion's Oral Hygiene Index measure: Marginal Fit of the Crown (RADIOLOGICAL) sex: ALL minimumAge: 9 Years maximumAge: 12 Years stdAges: CHILD facility: Afyonkarahisar Health Sciences University city: Afyonkarahisar zip: 03030 country: Turkey name: Burcu GUCYETMEZ TOPAL, Asst.Prof role: CONTACT phone: +90 530 281 35 85 email: dt.burcugucyetmez@hotmail.com name: Esma ATIS, Res.Ass. role: SUB_INVESTIGATOR lat: 38.75667 lon: 30.54333 hasResults: False

 nctId: NCT06318507 id: PBRC 2023-014 briefTitle: The Intestinal Microbiome in Triple Negative Breast Cancer Treated With Immunotherapy acronym: IMPACT overallStatus: RECRUITING date: 2024-03-11 date: 2024-12-31 date: 2025-12-31 date: 2024-03-19 date: 2024-03-19 name: Pennington Biomedical Research Center class: OTHER briefSummary: This study will determine how the intestinal microbiome differs between patients with obesity and early triple-negative breast cancer who achieve a pathologic complete response from preoperative anti-PD-1 immunotherapy (pembrolizumab) versus patients who do not. conditions: Breast Neoplasms studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: Fecal microbial diversity measure: Pathologic Complete Response (pCR) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pennington Biomedical Research Center status: RECRUITING city: Baton Rouge state: Louisiana zip: 70808 country: United States name: Justin Brown, Ph.D. role: CONTACT phone: 225-763-2715 email: justin.brown@pbrc.edu lat: 30.45075 lon: -91.15455 hasResults: False

 nctId: NCT06318494 id: Ankle-optogait briefTitle: Analysis of Jumping in Patients With Ankle Instability (Ankle-optogait) acronym: Ankle-optoga overallStatus: ACTIVE_NOT_RECRUITING date: 2022-04-28 date: 2025-01 date: 2025-07 date: 2024-03-19 date: 2024-03-19 name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio class: OTHER briefSummary: The study is, in accordance with current legislation, definable as a single-center interventional study with evaluations carried out at a single timeframe.

The objective of the study is to compare jumping performance between subjects with ankle instability and healthy volunteer subjects.

In particular, the primary objective is to verify the difference in the monopodalic CMJ value of the diseased limb of subjects with ankle instability compared to the control group at time 0.

The population is made up of patients suffering from ankle instability and a control group of healthy volunteers, divided as follows:

25 subjects GROUP A: Study group: patients suffering from ankle instability

25 subjects GROUP B: control group: healthy voluntary subjects not affected by ankle pathology conditions: Ankle Disease studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 50 type: ESTIMATED name: jumping performance measure: verify the difference in the monopodalic CMJ (countermovement jump test) of the diseased limb of subjects with ankle instability compared to the control group sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Istituto Clinico San Siro city: Milan country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06318481 id: IRB-80/2023 briefTitle: TADCLOT- a Double Blind Randomized Controlled Trial acronym: TADCLOT overallStatus: RECRUITING date: 2024-02-15 date: 2024-11-15 date: 2024-12-15 date: 2024-03-19 date: 2024-03-19 name: National Institute of Cardiovascular Diseases, Pakistan class: OTHER name: PharmEvo Pvt Ltd briefSummary: Compare the safety and efficacy of a twice-daily Clopidogrel regimen vs. Ticagrelor in reducing major adverse events in patients undergoing primary PCI in a double-blind randomized controlled trial. conditions: Stent Thrombosis conditions: Myocardial Infarction, Acute studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Care provider and investigator are same so both are blinded in the trial. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 2200 type: ESTIMATED name: Ticagrelor 90 MG name: Clopidogrel measure: Evaluation of efficacy and safety measure: Secondary endpoint sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institute of Cardiovascular Diseases status: RECRUITING city: Karachi state: SIndh zip: 755000 country: Pakistan name: Abdul Hakeem, MD role: CONTACT phone: 6086953048 email: ahakeem@gmail.com name: Jehangir Shah, MBBS role: CONTACT email: jehangirshah91@gmail.com lat: 24.8608 lon: 67.0104 hasResults: False

 nctId: NCT06318468 id: N202306106 briefTitle: The Effectiveness of Various Teaching Methods to Enhance the Comprehensive Nursing Assessment Skills of New Nurses overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10-31 date: 2024-10-31 date: 2024-03-19 date: 2024-03-19 name: Taipei Medical University WanFang Hospital class: OTHER briefSummary: This study is going to compare different teaching strategies for improving newly recruited nurses' comprehensive nursing assessment skills. conditions: Competence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Nursing health assessment teaching and discussion using humanoid diagrams name: Nursing health assessment teaching and discussion using case study measure: Comprehensive health assessment questionnaire measure: Comprehensive health assessment questionnaire measure: Comprehensive health assessment questionnaire measure: Confidence scale (C-scale) measure: Confidence scale (C-scale) measure: Confidence scale (C-scale) measure: Course satisfaction questionnaire sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei Medical University WanFang Hospital city: Taipei country: Taiwan name: Mei Fen Tang, master role: CONTACT phone: 0970746226 email: 5053@w.tmu.edu.tw lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06318455 id: İstanbul University-Cerrahpaşa briefTitle: The Effect of Breathing Exercise on Sleep and Stress Levels in Women With Breast Cancer Receiving Chemotherapy Treatment overallStatus: RECRUITING date: 2023-11-01 date: 2024-04-30 date: 2024-04-30 date: 2024-03-19 date: 2024-03-19 name: University of Yalova class: OTHER briefSummary: Women receiving chemotherapy have poor sleep quality and high stress levels. With a method such as breathing exercise, which can be applied at any time without side effects, positive improvements in women's sleep and stress levels can be recorded. conditions: Women Receiving Chemotherapy conditions: 18 Years of Age and Above conditions: Women With High Stress Levels conditions: Women With Poor Sleep Quality studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 65 type: ESTIMATED name: Breathing exercise measure: anxiety state scale sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of İstanbul-cerrahpaşa (IUC) status: RECRUITING city: Istanbul country: Turkey name: Gürcan Solmaz, PhD role: CONTACT phone: +90 5556287897 email: gurcansolmaz@hotmail.com name: Gürcan Solmaz role: CONTACT phone: +90 5556287897 email: gurcansolmaz@hotmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06318442 id: 22HH8018 briefTitle: The GAPSID Study - How GLP-1 Analogues Prevent Steroid-Induced Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-04-06 date: 2027-06-01 date: 2027-06-01 date: 2024-03-19 date: 2024-03-19 name: Imperial College London class: OTHER briefSummary: TITLE: How GLP-1 Analogues prevent steroid-induced diabetes (The GAPSID Study)

DESIGN: A double-blind study evaluating how GLP-1 analogues, compared with metformin, prevent hyperglycaemia in response to a 7-day course of dexamethasone (DEX) 6 mg once daily. This is a mechanistic experimental medicine study.

AIMS: To evaluate the mechanisms by which GLP-1 analogues reduce steroid-induced hyperglycaemia compared to metformin.

OUTCOME MEASURES:

* Primary: Glucose tolerance in response to standardised mixed meal test (MMT) lasting for 240 minutes, measured in all participants at baseline and on day 7 DEX.
* Secondary: Indices of insulin resistance (M-value), beta-cell function (acute insulin response to glucose) and disposition, as measured by a combined IV glucose tolerance test and hyperinsulinaemic-euglycaemic clamp, performed at baseline and on day 7 DEX.
* Exploratory: Tissue specific changes in adipose AMPK determined from adipose and muscle biopsies, taken from a subset of approximately 8 individuals in each group.

ELIGIBILITY: People living with pre-diabetes or lifestyle controlled diabetes

STUDY DURATION: This study will take place over 3 weeks for each partcipant. Study procedures include 10 days of baseline continuous glucose monitoring (CGM) followed by 7 days of dexamethasone with GLP-1, metformin or placebo. Participants will attend a follow-up visit 3-5 days after completing the 7-day course of study drug. The study will run over a period of 3 years.

ANTICIPATED IMPACT: Mechanistic evidence for the use of GLP-1 analogues, compared with metformin, in the treatment of steroid-induced diabetes. conditions: Steroid-Induced Diabetes conditions: Steroid Induced Hyperglycemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Semaglutide Oral Product name: Metformin Oral Tablet name: Placebo measure: Difference in Glucose tolerance measure: Difference in insulin secretion measure: Difference in insulin sensitivity measure: Difference in insulin sensitivity measure: Difference in insulin sensitivity measure: Mean glucose and glycaemic variation by continuous glucose monitoring (CGM), using a validated blinded system (Dexcom G7). measure: Changes in fasting gut hormones measure: Changes in fasting gut hormones measure: Changes in fasting gut hormones measure: Changes in fasting lipid profile measure: Changes in post prandial gut hormones measure: Changes in post prandial gut hormones measure: Changes in anthropometrics measure: Changes in anthropometrics measure: Tissue specific changes in AMPK determined from adipose and muscle biopsies sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Imperial College Healthcare NHS Trust city: London country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06318429 id: diabet briefTitle: Evaluation of the Effect of Stretching Exercises Applied to Diabetes Patients on Physiological Parameters and Compliance to Treatment: A Randomized Controlled Study overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-06-30 date: 2024-06-30 date: 2024-03-19 date: 2024-03-19 name: University of Yalova class: OTHER briefSummary: This research will be carried out as a pretest-posttest randomized controlled study to determine the effect of stretching exercises performed 2 days a week for 12 weeks for one hour each session on physiological parameters and treatment compliance in individuals with diabetes. conditions: Individuals With Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: stretching exercise group measure: blood sugar sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of İstanbul-cerrahpaşa (IUC) city: Istanbul country: Turkey name: GÜRCAN Solmaz, PhD role: CONTACT phone: +90 5556287897 email: gurcansolmaz@hotmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06318416 id: HSR230382 briefTitle: Precision Rifampin Trial for Personalized Dosing acronym: P-RIF overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-01-30 date: 2028-01-30 date: 2024-03-19 date: 2024-03-21 name: University of Virginia class: OTHER name: Haydom Lutheran Hospital name: Rutgers University briefSummary: Individual pharmacokinetic variability is an important driver of tuberculosis (TB) treatment failure particularly among undernourished populations, and that suboptimal serum drug concentrations are associated with delayed response to treatment, death, and acquired bacterial drug resistance. Serum drug exposures can be approximated by urine excretion as measured by spectrophotometry, replacing the need for specialized equipment for serum testing. Anti-TB pharmacokinetic variability has also been associated with enteric pathogen burden. The overall hypothesis is that urine spectrophotometry will identify people with below-target rifampin serum concentrations, which can be corrected to target levels after dose adjustment as confirmed by serum mass spectrometry. Therefore, this protocol includes a clinical trial to assess efficacy and safety of rifampin dose adjustment based on urinary excretion levels among adults and children who are being treated for drug-sensitive pulmonary TB at our longstanding collaborative research site in Haydom Lutheran Hospital, Tanzania. conditions: Tuberculosis studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: urine spectrophotometry for rifampin absorbance measure: Rifampin serum area under the concentration time curve for the 24 hour dosing interval measure: Adverse events measure: Time to sputum culture conversion to negative measure: Weight change sex: ALL minimumAge: 3 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06318403 id: 177012 briefTitle: Estradiol Supplementation and Rotator Cuff Repair acronym: ESTRCR overallStatus: NOT_YET_RECRUITING date: 2025-04 date: 2028-03 date: 2028-05 date: 2024-03-19 date: 2024-03-28 name: University of Utah class: OTHER briefSummary: Rotator cuff tears in the shoulder are common, often cause pain and disability, often fail to heal with surgery, and both tears and failure of healing are associated with estradiol deficiency. In this study, women who have gone through menopause will be randomized to either estradiol patches or placebo patches after repair of the rotator cuff. The purpose of this study is to determine whether estradiol patches show promise in improving shoulder pain, strength, and function when given with rotator cuff repair. conditions: Rotator Cuff Tears conditions: Rotator Cuff Injuries conditions: Rotator Cuff Syndrome conditions: Menopause Related Conditions conditions: Menopause studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 58 type: ESTIMATED name: Transdermal estrogen name: Rotator Cuff Repair Surgery measure: American Shoulder and Elbow Surgeons (ASES) Score measure: Simple Shoulder Test (SST) Score measure: Visual Analogue Score (VAS) for pain measure: Magnetic Resonance Imaging (MRI) tendon healing measure: Strength Assessment measure: Range of motion measure: Serum Hormone Measurement measure: Patch Count measure: Averse Event Assessment sex: FEMALE minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06318390 id: 2023-0271 briefTitle: The Impact of KETO5 XOGenius Beverage on Markers of Physiological and Neurocognitive Health overallStatus: RECRUITING date: 2023-08-01 date: 2024-12-31 date: 2025-08-31 date: 2024-03-19 date: 2024-03-19 name: The University of Texas at Arlington class: OTHER briefSummary: The primary objectives of this application are to 1) investigate the effect of increased daily consumption of the Keto5 XOGenius beverage on outcomes associated with elevated risk for various neurocognitive and pathophysiological conditions/diseases. And 2) to investigate the effect of daily consumption of the Keto5 XOGenius beverage on the following variables: waist circumference, body weight, and body mass index (BMI). conditions: Cardiovascular Diseases conditions: Hypertension conditions: Cognitive Decline conditions: Diet, Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: XO Genius measure: Endothelial Function measure: Neurocognitive Function measure: Peripheral blood pressure (systolic, diastolic, mean) measure: Lipid profile (Total-C, LDL-C, VLDL-C, HDL-C, TG) measure: Arterial stiffness sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: UT Arlington - Science and Engineering Innovation and Research Building status: RECRUITING city: Arlington state: Texas zip: 76019 country: United States name: Robert M Brothers, PhD role: CONTACT phone: 817-272-3288 email: matthew.brothers@uta.edu name: Alison Mancera, BS role: CONTACT phone: 8172723288 email: alison.mancera@mavs.uta.edu lat: 32.73569 lon: -97.10807 hasResults: False

 nctId: NCT06318377 id: 2022-0541 briefTitle: Peanuts and Neurocognitive / Cardiovascular Health in Black Individuals overallStatus: RECRUITING date: 2022-09-01 date: 2024-12-31 date: 2025-08-31 date: 2024-03-19 date: 2024-03-19 name: The University of Texas at Arlington class: OTHER briefSummary: The overall research objective of this proposal is to determine the impact of increased daily peanut consumption on indices of neurocognitive and physiological health in BL individuals conditions: Cardiovascular Diseases conditions: Hypertension conditions: Cognitive Decline conditions: Diet, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Individual will be randomly assigned either an experimental or a control condittion primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: Peanut group measure: Endothelial Function measure: Neurocognitive Function measure: Peripheral blood pressure (systolic, diastolic, mean) measure: Lipid profile (Total-C, LDL-C, VLDL-C, HDL-C, TG) measure: Arterial stiffness sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: UT Arlington - Science and Engineering Innovation and Research Building status: RECRUITING city: Arlington state: Texas zip: 76019 country: United States name: Robert M Brothers, PhD role: CONTACT phone: 817-232-3156 email: matthew.brothers@uta.edu name: Alison Mancera role: CONTACT phone: 817-232-3156 email: alison.mancera@mavs.uta.edu lat: 32.73569 lon: -97.10807 hasResults: False

 nctId: NCT06318364 id: TJ-IRB202402016 briefTitle: Postoperative Delirium in the Post-anesthesia Care Unit overallStatus: RECRUITING date: 2024-01-20 date: 2024-12-30 date: 2024-12-30 date: 2024-03-19 date: 2024-03-19 name: Qin Zhang class: OTHER name: National Natural Science Foundation of China briefSummary: This study aims to investigate the incidence of postoperative delirium (POD) in the PACU and analyze its influencing factors, in order to provide theoretical basis for early screening and intervention for high-risk POD population. Blood samples of some study subjects will be collected and analyzed using molecular detection methods to provide a basis and insights into the pathophysiological mechanisms of POD. conditions: Delirium, Postoperative studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3320 type: ESTIMATED name: NO Intervention measure: Postoperative delirium sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Hospital of Harbin Medical University status: RECRUITING city: Harbin state: Heilongjiang zip: 150000 country: China name: Yuting Liu role: CONTACT phone: Hongyan email: qin4298@sina.com name: Yuting Ma role: CONTACT phone: 3680 email: qin4298@sina.com lat: 45.75 lon: 126.65 facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430030 country: China name: Xiao Ran, phd role: CONTACT phone: 15926207366 email: ranxiao1001@tjh.tjmu.edu.cn name: Qin Zhang, phd role: CONTACT phone: 15717154768 email: qzhang8@tjh.tjmu.edu.cn name: Qin Zhang, phd role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06318351 id: TJ-IRB202402015 briefTitle: Transcutaneous Acupoint Electrical Stimulation and Postoperative Delirium Delirium overallStatus: RECRUITING date: 2024-02-01 date: 2024-12-30 date: 2025-08-30 date: 2024-03-19 date: 2024-04-09 name: Qin Zhang class: OTHER name: National Natural Science Foundation of China briefSummary: Investigating postoperative delirium in patients undergoing thoracoscopic lung resection surgery who have received or not received relevant transcutaneous acupoint electrical stimulation treatment preoperatively, observing postoperative recovery quality indicators, evaluating the necessity of treatment, and clarifying the potential mechanisms by which transcutaneous acupoint electrical stimulation may improve postoperative delirium. conditions: Delirium, Postoperative studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 476 type: ESTIMATED name: transcutaneous acupoint electrical stimulation measure: Delirium measure: Recovery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Hospital of Traditional Chinese Medicine status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Jiemin Deng role: CONTACT phone: 2780 email: qin4298@sina.com name: Jiemin Deng role: CONTACT lat: 23.11667 lon: 113.25 facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430030 country: China name: Qin Zhang, phd role: CONTACT phone: 15717154768 email: qzhang8@tjh.tjmu.edu.cn name: Qin Zhang, phd role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06318338 id: UPCC 14523 id: 854756 type: OTHER domain: Penn IRB briefTitle: Virtual Reality to Promote Relaxation Prior to Simulation overallStatus: RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-03-19 date: 2024-03-19 name: Abramson Cancer Center at Penn Medicine class: OTHER briefSummary: The purpose of this study is to assess the feasibility of a pre-simulation virtual reality (VR) platform designed to promote relaxation for cancer patients planned for radiation therapy (RT). conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 25 type: ESTIMATED name: Virtual Reality Program measure: Feasibility of a pre-simulation VR platform prior to radiation measure: Patient feedback on pre-simulation VR program measure: Patient situational anxiety prior to and after use of VR program sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Perelman Center for Advanced Medicine status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Ching Lai role: CONTACT phone: 267-250-9244 email: Ching.Lai@pennmedicine.upenn.edu lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06318325 id: ADINEGEV-2021_102 briefTitle: Growth Process and Development of the Musculoskeletal System in Young Gymnasts overallStatus: RECRUITING date: 2024-01-01 date: 2026-03-15 date: 2026-03-15 date: 2024-03-19 date: 2024-04-16 name: University of Haifa class: OTHER name: The Academic college Levinsky-Wingate at the Wingate Institute, Netanya, Israel briefSummary: assessment of the musculoskeletal system will be performed twice a year, for three years of young gymnasts. conditions: Development, Adolescent studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: examination measure: ultrasound tissue characterized measure: muscle strength test measure: range of motion measure: bone strength measure: Bone Age sex: FEMALE minimumAge: 9 Years maximumAge: 16 Years stdAges: CHILD facility: The Academic college Levinsky-Wingate at the Wingate Institute status: RECRUITING city: Netanya country: Israel lat: 32.33291 lon: 34.85992 hasResults: False

 nctId: NCT06318312 id: HYP_MR_2024 briefTitle: Effects of Hypoxia on Cognitive Performance acronym: HYPCOG overallStatus: NOT_YET_RECRUITING date: 2024-03-27 date: 2024-04-12 date: 2024-05-03 date: 2024-03-19 date: 2024-03-19 name: University of Castilla-La Mancha class: OTHER briefSummary: The goal of this clinical trial is to determine the effects of different hypoxia exposures (FiO2 = 11%, 13%, 15%, and 21%) on cognitive performance in healthy adults. The main questions it aims to answer are:

* What is the best hypoxia exposure to improve reaction time, anticipation, attention and memory tasks?
* Which hypoxia exposure causes the greatest detriments in cognitive function? conditions: Hypoxia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Hypoxia measure: Memory measure: Attention measure: Anticipation measure: Reaction time sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06318299 id: 109227 briefTitle: Effects of Exogenous Ketone Ester Supplementation on 3-hydroxybutyrate Concentrations in Human Cerebrospinal Fluid acronym: KetoBrain overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-19 date: 2024-03-21 name: University of Aarhus class: OTHER name: Aarhus University Hospital briefSummary: It is well established that the brain is capable of consuming ketone bodies, especially during low glucose availability, e.g. fasting. Cerebral metabolism of ketone bodies depends on passage of the blood brain barrier and especially the global blood concentration of ketone bodies.

Ketone bodies can be administered exogenously, and the most commonly used in clinical trials is 3-hydroxybutyrate (3-OHB). 3-OHB is carried by simple diffusion and facilitated diffusion through several monocarboxylic acid transporters (MCTs) across the blood-brain barrier.

To our knowledge, no studies in human adults exist that concurrently measure 3-OHB concentrations in blood and cerebrospinal fluid (CSF) after ingestion or infusion of exogenous ketone supplementation, necessitating further study.

Aims:

* The 3-OHB CSF/blood ratio after oral ingestion of 30 g ketone ester - primary endpoint
* The window of effect: Ketone supplementation 1 h or 2 h before CSF sampling
* If concentration measurements by point-of-care testing are non-inferior to mass spectrometry
* If acute 3-OHB ingestion increases plasma brain-derived neurotrophic factor (BDNF) levels conditions: Ketosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 24 type: ESTIMATED name: Ketone Ester name: Placebo measure: 3-OHB CSF/blood ratio measure: CSF 3-OHB concentrations, POCT measure: CSF 3-OHB concentrations, Mass Spectrometry measure: CSF glucose concentrations measure: Blood 3-OHB concentrations measure: Plasma 3-OHB concentrations measure: Blood glucose concentrations measure: Plasma BDNF concentrations measure: Blood 3-OHB concentrations measure: Plasma 3-OHB concentrations measure: Blood glucose concentrations measure: Plasma BDNF concentrations sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aarhus University Hospital city: Aarhus zip: 8200 country: Denmark name: Simon Kjær Simonsen, MD role: CONTACT phone: +45 28769491 email: simkjr@clin.au.dk name: Mads Vandsted Svart, PhD role: CONTACT phone: +45 28118221 email: mvsv@clin.au.dk lat: 56.15674 lon: 10.21076 hasResults: False

 nctId: NCT06318286 id: MK3475-IIT-60977 briefTitle: Study of Pembrolizumab Plus Chemotherapy With Lenvatinib for Malignant Pleural Mesothelioma acronym: PENINSULA overallStatus: NOT_YET_RECRUITING date: 2024-03-13 date: 2026-04-30 date: 2026-10-30 date: 2024-03-19 date: 2024-03-19 name: Hyogo Medical University class: OTHER name: Merck Sharp & Dohme LLC briefSummary: In this Phase-II study, the investigators will investigate the efficacy and safety of lenvatinib in combination with pembrolizumab and chemotherapy in patients with malignant pleural mesothelioma. conditions: Malignant Pleural Mesothelioma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a single-arm, open-label study to evaluate the efficacy and safety of lenvatinib in combination with pembrolizumab and chemotherapy in patients with malignant pleural mesothelioma. Patients 18 years of age or older will be eligible for enrollment if they had histologically confirmed unresectable malignant pleural mesothelioma. primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Lenvatinib name: Pemetrexed name: Cisplatin/Carboplatin name: Pembrolizumab measure: Tumor shrinkage (response rate) (Physician Judgment by Medical Institution, Modified RECIST [Response Evaluation Criteria in Solid Tumors] criteria) measure: Progression-Free survival (PFS) (Physician Judgment by Medical Institution, Modified RECIST criteria) measure: Overall survival time (OS) measure: Tumor shrinkage (disease control rate) (Physician Judgment by Medical Institution, Modified RECIST criteria) measure: Duration of response (Physician Judgment by Medical Institution, Modified RECIST criteria) measure: Best overall response (Physician Judgment by Medical Institution, Modified RECIST criteria) measure: Incidence of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hyogo Medical University Hospital city: Nishinomiya state: Hyogo zip: 6638501 country: Japan name: Kozo Kuribayashi, MD, PhD role: CONTACT phone: +81-798-45-6596 email: kuririn@hyo-med.ac.jp name: Tetsuya Takagawa, MD, PhD role: CONTACT phone: +81- 798-45-6265 email: takagawa@hyo-med.ac.jp name: Nobukazu Fujimoto, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Keisuke Aoe, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.71562 lon: 135.33199 hasResults: False

 nctId: NCT06318273 id: M24-742 briefTitle: A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer overallStatus: RECRUITING date: 2024-03-08 date: 2027-06-16 date: 2027-06-17 date: 2024-03-19 date: 2024-04-09 name: AbbVie class: INDUSTRY briefSummary: Prostate cancer has the second highest incidence rate and is the fifth leading cause of cancer-related deaths among men worldwide. The purpose of this study is to assess safety, pharmacokinetics, and efficacy of ABBV-969 as a monotherapy.

ABBV-969 is an investigational drug being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). There are parts to this study. Participants will receive ABBV-969 as a single agent at different doses. Approximately 120 adult participants will be enrolled in the study across sites worldwide.

In part 1 (dose escalation), ABBV-969 will be intravenously infused in escalating doses as a monotherapy. In part 2, multiple doses will be selected from Part 1 and mCRPC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. The estimated duration of the study is up to 3 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans. conditions: Metastatic Castration-Resistant Prostate Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: ABBV-969 measure: Percentage of Participants With Adverse Events (AEs) measure: Percentage of Participants Achieving Prostate Specific Antigen (PSA) response measure: Maximum Observed Plasma Concentration (Cmax) of ABBV-969 measure: Time to Maximum Observed Concentration (Tmax) of ABBV-969 measure: Terminal Phase Elimination Half-Life (t1/2) of ABBV-969 measure: Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-969 measure: Antidrug Antibody (ADA) measure: Neutralizing Antibodies (nAbs) measure: Recommended Phase 2 Dose (RP2D) of ABBV-969 (Dose-Escalation Phase) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope /ID# 262059 status: RECRUITING city: Duarte state: California zip: 91010 country: United States lat: 34.13945 lon: -117.97729 facility: Carolina BioOncology Institute /ID# 261602 status: RECRUITING city: Huntersville state: North Carolina zip: 28078 country: United States lat: 35.41069 lon: -80.84285 facility: NEXT Oncology /ID# 261601 status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States lat: 29.42412 lon: -98.49363 hasResults: False

 nctId: NCT06318260 id: 2023-508298-10-00 briefTitle: Haemodynamic Effects of Dobutamine in Patients With Wild-type Transthyretin Amyloid Cardiomyopathy (ATTRwt) acronym: DobATTR overallStatus: RECRUITING date: 2024-04-08 date: 2025-09 date: 2026-03 date: 2024-03-19 date: 2024-04-17 name: Steen Hvitfeldt Poulsen class: OTHER briefSummary: The goal of this clinical trial is to test the effects of the inotropic drug named dobutamine, in patients with wild-type Transthyretin Amyoid Cardiomyopathy (ATTRwt). The main questions it aims to answer are:

* What are the effects of increasing dosages of dobutamine infusion on cardiac output and filling pressures in patients with symptomatic ATTRwt.
* Safety of dobutamine infusion in this patient population.

Participants will be given increasing dosages of dobutamine infusion, and its effect on cardiac output and filling pressures will be assessed non-invasively by echocardiography, and invasively by right heart catheterization, simultaneously. conditions: ATTR Amyloidosis Wild Type studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, single-centre, one arm clinical explorative study, with consecutive enrolment. primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Dobutrex measure: Cardiac output measure: Increase in invasively measured SVI by ≥ 20%. measure: Reduction in mean PAWP and/or mPAP by 10 %. measure: Increase in LVEF and LV-global longitudinal strain (LV-GLS) of absolute 10 %. measure: Correlation between echo- and invasive measured SVI, and CO. measure: Rate of complications (i.e. Systolic blood pressure drop < 90 mmHg, arrhythmias)/symptomatic side effects. sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Department of Cardiology, Aarhus University Hospital status: RECRUITING city: Aarhus zip: 8200 country: Denmark name: Ali Hussein Jaber Mejren, MD role: CONTACT phone: 0045 91 65 18 48 email: alimej@clin.au.dk lat: 56.15674 lon: 10.21076 hasResults: False

 nctId: NCT06318247 id: 2022-134(R) briefTitle: Using Xenograft Combined With Barrier Membrane to Improve the Formation of Deep Periodontal Pockets overallStatus: RECRUITING date: 2023-06-01 date: 2024-12-30 date: 2025-12-30 date: 2024-03-19 date: 2024-03-19 name: The Dental Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: To evaluate the clinical effect of site preservation after third molars extraction by using tooth extraction of third molars with site preservation using bio-oss and bio-guide in preventing the formation of deep periodontal pockets in the distal of second molars. conditions: Periodontal Pocket conditions: Periodontal Bone Loss conditions: Impacted Third Molar Tooth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: site preservation measure: Probing pocket depths (PPD) measure: Distal bone wall defect (DBWD) measure: Clinical attachment lose (CAL) measure: Bleeding on probing (BOP) measure: Pain score measure: Patient satisfaction measure: Gingival index (GI) sex: ALL minimumAge: 26 Years maximumAge: 45 Years stdAges: ADULT facility: Stomatology Hospital, Zhejiang University School of Medicine status: RECRUITING city: Hangzhou state: Zhejiang zip: 310000 country: China name: Jue Shi, Doctor role: CONTACT phone: +86 13757171359 email: dentistsj@zju.edu.cn lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06318234 id: 202435 briefTitle: PET/MR Evaluation of Regression Grading After Neoadjuvant Therapy for Rectal Cancer overallStatus: RECRUITING date: 2024-01-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-19 date: 2024-03-19 name: Xiao Chen class: OTHER briefSummary: This project aims to evaluate the role of 18F-FAPI combined with 18F-FDG PET/MRI imaging in quantitatively and accurately evaluating the grading of rectal cancer after SCRT neoadjuvant therapy in patients with advanced rectal cancer as the research object, with postoperative histopathological analysis as the reference index, and to assess the ability of patients to achieve pCR. A diagnostic model and evaluation system will also be constructed. conditions: Rectal Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 32 type: ESTIMATED name: 18F-FAPI，18F-FDG measure: Evaluation efficacy of tumor regression level measure: expression of FAP measure: expression of GLUT1 measure: SUV sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University status: RECRUITING city: Chongqing country: China name: Xiao Chen, Ph.D role: CONTACT phone: +8615922970174 email: xiaochen229@foxmail.com lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06318221 id: 06156930 briefTitle: Effects of Perioperative Immunonutrition in Patients With Head and Neck Cancer overallStatus: COMPLETED date: 2019-05-01 date: 2021-02-01 date: 2021-02-01 date: 2024-03-19 date: 2024-03-19 name: TC Erciyes University class: OTHER briefSummary: A prospective randomized controlled study compared the effects of perioperative immunonutrition and standard enteral nutrition (EN) on postoperative short-term outcomes of patients with head and neck (HNC).

Five days before surgery and the postoperative day 10, immunonutrition support was given to the intervention group (n=17), and standard EN support was given to the control group (n=17). Body analyses were made, food consumption records were taken, NRS-2002 and quality of life scales were applied, and biochemical parameters were recorded. conditions: Head and Neck Cancer conditions: Nutrition, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients were classified according to tumor location (oral cavity, oropharynx, larynx or hypopharynx) and body weight loss, approximately equally in both groups. Accordingly, patients were randomly assigned (by computer) into either the immunonutrition (intervention group) or standard EN (control group) groups. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 34 type: ACTUAL name: Experimental (Immunonutrition) Group name: Active Comparator Group ( Standard enteral nutrition) measure: Body weight measure: Body weight loss measure: Body mass index measure: Resting metabolic rate measure: Nutrition Risk Screening 2002 measure: The EORTC Core Quality of Life questionnaire-30 (EORTC QLQ-C30) measure: The EORTC Quality of life - Head and Neck Cancer Module (EORTC QLQ-H & N35) measure: Albumin measure: C-reactive protein measure: Prealbumin measure: Length of hospital stay measure: Complication development status sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erciyes University city: Talas state: Kayseri zip: 38280 country: Turkey lat: 38.6908 lon: 35.5538 hasResults: False

 nctId: NCT06318208 id: C-LCI briefTitle: Pulmonary Function in Non-hospitalized Adults and Children After Mild COVID-19 overallStatus: COMPLETED date: 2021-04-20 date: 2022-01-03 date: 2022-01-03 date: 2024-03-19 date: 2024-03-26 name: University of Rostock class: OTHER briefSummary: The study investigates whether patients with mild SARS-CoV-2 infection, who stayed at home during their infection and weren't hospitalized, have any persisting sequelae in pulmonary function.

Therefore, 110 patients, aged 6-60 years, were recruited by telephone 4-12 weeks after laboratory-confirmed positive PCR and invited for a lung function testing. Every patient with abnormalities in pulmonary function was invited to a follow-up 3 months after the first appointment to assess changes in lung function values.

Patients with a pre-existing lung disease and smokers within the last five years were excluded beforehand.

Additionally to lung function testing we did a throat swab at each appointment to analyse via Multiplex PCR whether the patients had any other respiratory infection at the time of the pulmonary function testing. conditions: SARS-CoV-2 Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 110 type: ACTUAL name: lung function testing measure: Pulmonary function measure: Changes in pulmonary function measure: Sociodemographic factors sex: ALL minimumAge: 6 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: Kinder- und Jugendklinik Universitätsmedizin Rostock city: Rostock zip: 18057 country: Germany lat: 54.0887 lon: 12.14049 hasResults: False

 nctId: NCT06318195 id: 2023-06821-01 briefTitle: Condensed Digital Prolonged Exposure for Individuals Treated Within Somatic Trauma Care. acronym: CiPE overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-02 date: 2026-08 date: 2024-03-19 date: 2024-03-19 name: Karolinska Institutet class: OTHER name: Karolinska Universitetssjukhuset briefSummary: The purpose of the study is to investigate the feasibility of implementation aspects, treatment effects and change processes regarding a brief trauma-focused Internet-based CBT treatment, for patients who have been treated in trauma care at Karolinska University Hospital and who exhibit symptoms of psychological consequences of the traumatic event. Another aim is to explore factors (predictors, moderators and mediators) that influence the effect of the treatment, in order to better understand who responds to the treatment. conditions: Post Traumatic Stress Disorder conditions: Acute Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prolonged exposure will be offered in a brief digital format with therapist support for three weeks. Treatment comprises of psychoeducation, rationales, in vivo exposure, imaginal exposure and relapse prevention. primaryPurpose: TREATMENT masking: NONE count: 250 type: ESTIMATED name: Condensed Internet delivered prolonged exposure (CIPE) measure: Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5) measure: Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) measure: Change in psychosocial impairment measured by The Work and Social Adjustment Scale (WSAS), adapted to symptoms of post-traumatic stress. measure: Participants satisfaction with treatment. measure: Adverse events related to treatment. measure: Number of completed treatment modules measure: Number of messages sent and received in the digital platform measure: Number of completed home work assignments by the participant during the treatment period measure: The proportion of participants that conducts the weekly measures and further assessment points measure: The proportion of participants that go through the entire treatment period measure: Number of drop-outs from treatment measure: Rates of inclusion to the study sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karolinska Universitetssjukhuset; Tema Kvinnohälsa och Hälsoprofessioner; Medicinsk Enhet Medicinsk Psykologi; Sektion Beteendemedicin city: Stockholm country: Sweden name: Charlotte Gentili, PhD role: CONTACT phone: +46760482895 email: charlotte.s.gentili@regionstockholm.se name: Mike Kemani, PhD role: CONTACT email: mike.kemani@regionstockholm.se lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06318182 id: NCT-SBF-EK-001 briefTitle: Testicular Self-Examination Awareness in Young Men overallStatus: ACTIVE_NOT_RECRUITING date: 2022-12-09 date: 2023-11-20 date: 2024-07-15 date: 2024-03-19 date: 2024-03-19 name: Hitit University class: OTHER name: Ondokuz Mayıs University briefSummary: This study aims to determine the effect of education based on the health belief model on testicular self-examination awareness and health beliefs in young men.

H0 Hypothesis: Education based on the health belief model has no effect on the awareness of testicular self-examination and health beliefs about testicular self-examination of young men in the experimental and control groups.

H1a Hypothesis: The training based on the health belief model will increase the awareness of young men in the experimental group about testicular self-examination compared to those in the control group.

H1b Hypothesis: The training based on the health belief model will increase the mean scores of the sensitivity subscale of young men in the experimental group compared to those in the control group.

H1c Hypothesis: The training based on the health belief model will increase the mean scores of the benefit subscale of young men in the experimental group compared to those in the control group.

H1d Hypothesis: The training based on the health belief model will increase the mean scores of the seriousness subscale of young men in the experimental group compared to those in the control group.

H1e Hypothesis: The training based on the health belief model will decrease the mean scores of the barriers subscale of young men in the experimental group compared to those in the control group.

H1f Hypothesis: The training based on the health belief model will increase the mean scores of the health motivation subscale of young men in the experimental group compared to those in the control group.

H1g Hypothesis: The training based on the health belief model will increase the mean scores of the self-efficacy subscale of young men in the experimental group compared to those in the control group. conditions: Testicular Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 120 type: ACTUAL name: Education measure: Demographic information and testicular cancer questionnaire measure: Testicular Cancer Knowledge Test measure: Health Beliefs Scale for Testicular Cancer and Testicular Self-Examination measure: For the control group, Testicular Cancer Knowledge Test measure: For the control group, Health Beliefs Scale for Testicular Cancer and Testicular Self-Examination measure: Testicular Cancer Knowledge Test measure: Health Beliefs Scale for Testicular Cancer and Testicular Self-Examination sex: MALE minimumAge: 15 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Hitit University city: Corum zip: 19000 country: Turkey lat: 40.54889 lon: 34.95333 hasResults: False

 nctId: NCT06318169 id: BIO89-100-131 briefTitle: A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis) overallStatus: RECRUITING date: 2024-03-13 date: 2026-12 date: 2029-02 date: 2024-03-19 date: 2024-04-29 name: 89bio, Inc. class: INDUSTRY briefSummary: The study will assess the efficacy and safety of 2 dose regimens of pegozafermin for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH (previously known as nonalcoholic steatohepatitis \[NASH\]). conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1050 type: ESTIMATED name: Pegozafermin name: Placebo measure: Proportion of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of MASH/NASH at Week 52 measure: Proportion of Participants With MASH/NASH Resolution Without Worsening of Fibrosis at Week 52 measure: Change From Baseline in Liver Fat as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 52 measure: Change from Baseline in Alanine Aminotransferase (ALT) at Week 52 and Month 36 measure: Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 89bio Clinical Study Site status: RECRUITING city: Little Rock state: Arkansas zip: 72211-3859 country: United States name: 89bio Clinical Study Site role: CONTACT lat: 34.74648 lon: -92.28959 facility: 89bio Clinical Study Site status: RECRUITING city: Ocala state: Florida zip: 34471 country: United States name: 89bio Clinical Study Site role: CONTACT lat: 29.1872 lon: -82.14009 facility: 89bio Clinical Study Site status: RECRUITING city: Hermitage state: Tennessee zip: 37076 country: United States name: 89bio Clinical Study Site role: CONTACT lat: 36.19617 lon: -86.6225 facility: 89bio Clinical Study Site status: RECRUITING city: Wichita Falls state: Texas zip: 76301 country: United States name: 89bio Clinical Study Site role: CONTACT lat: 33.91371 lon: -98.49339 facility: 89bio Clinical Study Site status: RECRUITING city: Richmond state: Virginia zip: 23226-1925 country: United States name: 89bio Clinical Study Site role: CONTACT lat: 37.55376 lon: -77.46026 hasResults: False

 nctId: NCT06318156 id: ZSLL-KY-2024-056-03 briefTitle: Exploring the Distribution Patterns and Infrared Characteristics of Force-sensitive Acupoints in Different Lumbar Nerve Segments in Patients With LDH Based on "Press Quickly" Theory overallStatus: RECRUITING date: 2022-01-01 date: 2025-01-01 date: 2025-01-01 date: 2024-03-19 date: 2024-03-19 name: Zhou Xingchen class: OTHER briefSummary: Utilizing the "responsive acupoint palpation" technique and infrared thermography, we investigated the distribution patterns of pressure-sensitive acupoints across different lumbar spinal segments in patients with lumbar disc herniation (LDH). Methodology: The Finger TPS tactile pressure measurement system was employed to conduct sensitivity examinations on the acupoints of the L1\~L5 lumbar spine in 80 LDH patients (Group 1) and 80 healthy individuals (Group 2), applying a standardized force of 60N. When a sensation of comfort was elicited, the points were marked on a human cutaneous nerve segment map. We then utilized infrared thermography to collect and compare the temperature differences of the top 10 most frequently responsive acupoint areas in the experimental group against those in the control group. conditions: Lumbar Disc Herniation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: Infrared thermal imaging measure: skin temperature sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University status: RECRUITING city: Hangzhou state: Zhejiang zip: 310053 country: China name: Xingchen Zhou, Dr role: CONTACT phone: +86-18370133761 email: zhouxingchen0210@163.com lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06318143 id: U01HL168084 type: NIH link: https://reporter.nih.gov/quickSearch/U01HL168084 briefTitle: mAnaging siCkle CELl disEase Through incReased AdopTion of hydroxyurEa in Nigeria acronym: ACCELERATE overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2027-08 date: 2028-03 date: 2024-03-19 date: 2024-04-16 name: New York University class: OTHER briefSummary: Large knowledge gaps remain regarding strategies to promote the adoption of hydroxyurea (HU), particularly in sub-Saharan African countries including Nigeria, where more than 75% of annual sickle cell anemia births occur. The vast majority of people with SCD in Africa do not receive evidenced-based health care (e.g., newborn screening, health education, prophylaxis for infection, optimal nutrition and hydration, blood transfusion, transcranial Doppler screening, and HU therapy), despite its effectiveness in reducing SCD-related adverse outcomes and mortality. The use of HU in SSA is \<1% among SCD patients. The investigators' preliminary findings indicate that provider-level barriers are significant and must be addressed to improve HU adoption. To address HU adoption, the investigators will use the NIH-funded study (e.g., Realizing Effectiveness Across Continents with Hydroxyurea (REACH) Clinical Trial (NCT01966731)) that developed an evidence-informed, clinical, practical, and easy-to-follow algorithm to 1) Screen patients for sickle cell disease (SCD), 2) Initiate HU treatment, and 3) Maintain HU dosage over time (SIM) for the improved management of SCD as our intervention. The Nigerian government released guidelines supporting the SIM intervention for HU adoption for improved SCD management, and HU is on the list of essential medicines for Nigeria. The investigators' implementation strategy for improving SCD management in Nigeria uses a practical and replicable evidence-based task-sharing strategy, TAsk-Strengthening Strategy for Hemoglobinopathies (TASSH), adopted from the TAsk-Strengthening Strategy for Hypertension control (TASSH) trials in Ghana and Nigeria containing the essential components of i) Training healthcare workers/providers to be more patient-centered in clinical consultations, ii) Clinical reminders, and iii) Practice facilitation (TCP) known as (TASSH TCP) for SCD management. Using a sequential exploratory mixed-methods study design, the investigators will conduct this study using the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework in four sequential phases to assess the effectiveness of SIM adoption by providers in the context of the TASSH TCP implementation strategy in Nigeria. conditions: Sickle Cell Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 900 type: ESTIMATED name: TASSH measure: Patient numbers - screening measure: Patient numbers - proportion on HU measure: Patient numbers - dosage measure: Mediators sex: ALL minimumAge: 9 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06318130 id: LEAD-LBP briefTitle: Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes acronym: LEAD-LBP overallStatus: RECRUITING date: 2023-01-01 date: 2024-12-31 date: 2025-06-30 date: 2024-03-19 date: 2024-04-05 name: National University Hospital, Singapore class: OTHER briefSummary: This trial seeks to evaluate the performance of the extendable helix, stylet-driven pacing lead (EHL) compared to the fixed helix, lumenless pacing lead (FHL) during left bundle branch pacing (LBBP), with respect to enduring left bundle branch capture on follow-up, incidence of acute lead failure, pacing characteristics including QRS duration, pacing thresholds, R-wave amplitudes and lead impedance, and finally, safety profile during LBBP implantation. These data will guide future lead selection during LBBP implantation in achieving improved procedural success and optimal lead performance. conditions: Pacemaker DDD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A target of 210 participants will be enrolled in this study consisting of two groups and randomised in a 1:1 fashion to either of two groups.

Group 1: Fixed helix, lumenless pacing lead (FHL) Group 2: Extendable helix, stylet driven pacing lead (EHL) primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Subjects will be blinded to the type of pacing lead received. Operators will not be blinded as they will be performing the procedure. Post-procedure, investigators and outcomes assessors will be blinded to the treatment arm during adjudication of outcomes. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 210 type: ESTIMATED name: Fixed helix, lumenless pacing lead. name: Extendable helix, stylet-driven pacing lead. measure: Incidence of loss of left bundle branch capture measure: Incidence of acute lead failure measure: Serial changes in pacing thresholds (V) measure: Serial changes in R-wave amplitude (mV) measure: Serial changes in lead impedance (ohm) measure: Serial changes in QRS duration (ms) measure: Incidence of peri-procedural complications sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National University Heart Centre Singapore status: RECRUITING city: Singapore country: Singapore name: Eugene Tan, MBBS role: CONTACT phone: +6567795555 email: esjtan@nus.edu.sg lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06318117 id: 3398-1 briefTitle: Reason for Prescribing Rice Infant Formula overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-09-30 date: 2025-12-31 date: 2024-03-19 date: 2024-03-25 name: Mead Johnson Nutrition class: INDUSTRY name: BioFortis briefSummary: The main purpose of this study is to describe the pattern of RIF consumption in real life conditions, whatever the reasons of initiation and the chosen formula. The main objective is to study the reasons for prescribing a RIF during the first year of life, as per the pediatrician. Consumption started before 6 months of age, when milk and infantile formulas predominates in the baby's feeding, is of particular interest. conditions: Infant Formula studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 120 type: ESTIMATED name: Rice infant formula measure: Questionnaire - reason for prescribing a RIF during the 1st year of life. measure: Questionnaire - Reason for prescribing a RIF in first 6 months of life measure: Questionnaire - Diet characteristics measure: Growth z-scores body mass index (BMI)-for-age measure: Growth z-score measure: Growth z-score measure: Growth z-score measure: Growth z-score measure: Questionnaire - Evolution of digestive and allergic symptoms measure: Socio-demographic characteristics sex: ALL minimumAge: 6 Months maximumAge: 11 Months stdAges: CHILD facility: Dr Christine REGIMBART - Private Practice city: Bécon-les-Granits state: Becon-les-Granits zip: 49026 country: France name: Christine Regimbart, MD role: CONTACT lat: 47.50134 lon: -0.8 facility: Centre Hospitalier d'Auxerre - Neonatology and pediatric emergency department city: Auxerre zip: 89011 country: France name: Bertrand Soto, MD role: CONTACT lat: 47.8 lon: 3.56667 facility: Centre Hospitalier Universitaire de Nantes - Pediatric emergency department city: Nantes zip: 44093 country: France name: Hugues Piloquet, MD role: CONTACT lat: 47.21725 lon: -1.55336 facility: Hôpital NOVO - Pediatric department city: Pontoise zip: 95300 country: France name: Mariana Englender, MD role: CONTACT lat: 49.05 lon: 2.1 hasResults: False

 nctId: NCT06318104 id: DI/24/310/03/4 briefTitle: Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Tegoprazan vs Esomeprazole overallStatus: NOT_YET_RECRUITING date: 2024-04-19 date: 2024-11-29 date: 2025-02-28 date: 2024-03-19 date: 2024-03-19 name: Hospital General de México Dr. Eduardo Liceaga class: OTHER_GOV briefSummary: In Mexico, quadruple therapy is used to treat Helicobacter pylori (H.P.) at the expense of greater adverse effects, costs, and lower adherence to treatment. According to evidence, a competitive potassium channel blocker (P-CAB) is non-inferior to a proton pump inhibitor (PPI) and can improve the eradication rate of H.P. while maintaining triple therapy antibiotics (amoxicillin-clarithromycin) without increasing adverse effects, fewer drugs and better adherence to treatment. It is proposed to study the effect of a P-CAB in the eradication of H.P. as part of a triple therapy in Mexican patients, assuming that the efficacy and safety of a triple therapy of amoxicillin-clarithromycin-tegoprazan will be superior to amoxicillin-clarithromycin-esomeprazole. conditions: Helicobacter Pylori Infection studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 160 type: ESTIMATED name: Tegoprazan name: Esomeprazole 40mg measure: Response to treatment by determining the eradication rate measure: Compared Treatment-related adverse events measure: Brief Medication Questionnaire measure: Percentage of patients with adherence to treatment measure: Report all Treatment-related adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06318091 id: MS.21.09.1640 briefTitle: Nanofat Versus Platelet Poor Plasma Gel for Infraorbital Rejuvenation overallStatus: COMPLETED date: 2021-06-01 date: 2023-06-01 date: 2023-06-01 date: 2024-03-19 date: 2024-03-19 name: Mansoura University class: OTHER briefSummary: this study was conducted for evaluation of the clinical efficacy, safety, and potential side effects of platelet poor plasma gel versus nonfat injection in infraorbital rejuvenation conditions: Tear Trough Eyelid Deformity studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: platelet poor plasma gel name: nanofat measure: the degree of changes in the skin texture and homogeneity sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Manousra University, Faculty of Medicine city: Mansoura state: Dakahlia zip: 35511 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06318078 id: UG2024001 briefTitle: Buikwe Electronic Community Health Information System Impact Study overallStatus: RECRUITING date: 2023-12-01 date: 2024-04 date: 2024-07 date: 2024-03-19 date: 2024-03-19 name: Malaria Consortium class: OTHER briefSummary: The purpose of the study is to investigate the impact of the eCHIS intervention on key child health outcomes. conditions: Malaria conditions: Diarrhea conditions: Pneumonia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cluster Randomised Control Trial primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 1140 type: ESTIMATED name: eCHIS measure: Out Patient Department attendance (due to malaria, pneumonia and diarrhoea) measure: Hospitalisation (due to malaria, pneumonia and diarrhoea) measure: malaria related mortality in the community and health facilities sex: ALL minimumAge: 3 Months maximumAge: 59 Months stdAges: CHILD facility: Buikwe status: RECRUITING city: Buikwe country: Uganda name: John Baptist Bwanika, MD role: CONTACT name: John Baptist Bwanika, MD role: PRINCIPAL_INVESTIGATOR lat: 0.3375 lon: 33.01056 hasResults: False

 nctId: NCT06318065 id: B-ER111-370 briefTitle: Surgical Resection Outcomes in Patients With Brain Metastasis overallStatus: RECRUITING date: 2010-01-01 date: 2024-06-01 date: 2024-09-01 date: 2024-03-19 date: 2024-03-22 name: National Cheng-Kung University Hospital class: OTHER briefSummary: While many studies have investigated the prognostic factors for patients undergoing surgical resection for primary brain tumors, decision-making for patients with brain metastasis (BM) is more complex because of their higher burden of comorbidities compared to those with primary brain tumors. In addition, although various prognostic indicators have been identified to predict prognosis in several types of cancer, such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), prognostic nutritional index (PNI), and systemic immune-inflammation index (SII), limited studies have yet determined which group of patients would yield beater survival outcome after surgical resection for BM. This study aimed to investigate the impact of patient and perioperative characteristics and prognostic indicators on survival outcome of patients undergoing surgical resection of BM. conditions: Brain Metastases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED measure: survival outcome of patients undergoing surgery for brain metastasis measure: Functional outcome of patients undergoing surgery for brain metastasis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jung-Shun Lee status: RECRUITING city: Tainan state: None Selected zip: 70403 country: Taiwan name: Jung-Shun Lee, M.D. role: CONTACT phone: 886-6-2353535 phoneExt: 5181 email: nslee1218@gmail.com lat: 22.99083 lon: 120.21333 hasResults: False

 nctId: NCT06318052 id: LUM-ABU-CO2-FemTouch-19-01 briefTitle: The Effect Of Fractional CO2 Laser Therapy On Cancer Survivors With Genitourinary Syndrome Of Menopause (GSM) overallStatus: RECRUITING date: 2019-11-01 date: 2024-11 date: 2024-11 date: 2024-03-19 date: 2024-03-20 name: Lumenis Be Ltd. class: INDUSTRY briefSummary: Improvement in cancer therapies has led to an increase in the number of women surviving chemotherapy (and other treatments) and overcoming cancer. This patient population presents specific clinical needs as chemotherapy (and other cancer treatments) treatment side effects can lead to early appearance of menopause symptoms and conventional hormonal treatments are contraindicated for these patients. The use of CO2 laser treatment has been shown to provide relief of Genitourinary Syndrome Of Menopause (GSM) symptoms in women and might provide a significant improvement in the quality of life for cancer survivors. The current study is designed to demonstrate the safety and efficacy of CO2 laser for treatment of GSM symptoms in cancer survivors suffering from GSM symptoms, with limited access to hormonal treatment. conditions: Vaginal Atrophy Patients With GSM studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 68 type: ESTIMATED name: The FemTouch delivery system name: Gynomunal gel treatment measure: To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment measure: To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment measure: To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment. sex: FEMALE minimumAge: 21 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Frauenarztpraxis Heussweg status: RECRUITING city: Hamburg zip: 20255 country: Germany name: Matthias Theden-Scow, Dr role: CONTACT phone: 4210613 phoneExt: 040 email: dr.theden-schow@hamburg.de lat: 53.57532 lon: 10.01534 hasResults: False

 nctId: NCT06318039 id: IRB2022-06554-01 briefTitle: Operation ACL: Rehabilitation After Anterior Cruciate Ligament Reconstruction overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2027-03-01 date: 2027-10-01 date: 2024-03-19 date: 2024-04-08 name: Linnaeus University class: OTHER briefSummary: Scientific Research Question

Overall Purpose:

Regarding rehabilitation after anterior cruciate ligament reconstruction (ACLR), there is a knowledge gap - a lack of evidence. Important questions such as how rehabilitation should be structured, what it should include, and how it should be evaluated are currently not clear. Therefore, the investigators plan to conduct a two-year follow-up randomized controlled trial (RCT) on post-ACLR rehabilitation.

Moreover, detailed information on how/under what circumstances the ACL injury occurred is not satisfactorily described in the literature. Therefore, the investigators are planning a new survey that can identify, explain, and prevent the risk factors causing a person to suffer from an anterior cruciate ligament injury.

Specific Objectives:

How should guidelines for rehabilitation after ACLR be structured, what should they include, and how should they be evaluated to best restore knee function in the patient? Can a detailed and comprehensive survey identify, explain, and prevent the risk factors causing a person to suffer from an ACL injury? conditions: Anterior Cruciate Ligament Reconstruction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Novel program name: Traditional program measure: Isokinetic muscle strength measure: Single-leg hop performance measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) measure: ACL Return to Sport after Injury scale sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Linnaeus University city: Kalmar state: Sverige zip: 39363 country: Sweden lat: 56.66157 lon: 16.36163 hasResults: False

 nctId: NCT06318026 id: R01AA031231 type: NIH link: https://reporter.nih.gov/quickSearch/R01AA031231 id: R01AA031231 type: NIH link: https://reporter.nih.gov/quickSearch/R01AA031231 briefTitle: Systematic Implementation of Patient-centered Care for Alcohol Use Trial: Beyond Referral to Treatment overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2029-02 date: 2029-02 date: 2024-03-19 date: 2024-03-20 name: Kaiser Permanente class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) name: Kaiser Permanente Washington name: University of Washington briefSummary: The Systematic Implementation of Patient-centered Care for Alcohol Use Trial is a pragmatic, cluster-randomized, effectiveness-implementation trial testing two interventions to systematically implement shared decision-making with primary care patients with symptoms due to alcohol use: a primary care intervention and a centralized intervention. An anticipated 30 primary care clinics will be randomized to one of three conditions: usual care or the primary care or centralized interventions. conditions: Alcohol Use Disorder conditions: Unhealthy Alcohol Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: EHR and survey (latter masked) whoMasked: OUTCOMES_ASSESSOR count: 1500 type: ESTIMATED name: Centralized Intervention name: Primary Care Intervention measure: Documentation of alcohol or substance use disorder treatment in the electronic health record (including insurance claims). measure: Continuous measure of change in alcohol use as documented on the AUDIT-C screening questionnaire. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kaiser Permanente Washington city: Seattle state: Washington zip: 98112 country: United States name: Megan Addis role: CONTACT phone: 206-287-2052 email: Megan.J.Addis@kp.org lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06318013 id: 2022-KAEK-15427-04-204-2022101 briefTitle: Perineural and Systemic Dexamethasone Use in Dental Surgeries in Terms of Anesthesia Duration and Postop Complaints overallStatus: RECRUITING date: 2024-03-27 date: 2024-04-15 date: 2024-07-01 date: 2024-03-19 date: 2024-03-29 name: Karamanoğlu Mehmetbey University class: OTHER briefSummary: Participants will be asked to use some medications after the tooth extraction procedure. These drugs can be used in different ways. Investigators plan to monitor the pain, swelling and duration of anesthesia in the body as a result of participants use. conditions: Impacted Third Molar Tooth studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 60 type: ESTIMATED name: vitality test measure: Swelling measure: Duration of anesthesia measure: Pain Score sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Karamanoğlu Mehmetbey University Ahmet Keleşoğlu Faculty of Dentistry status: RECRUITING city: Karaman zip: 70100 country: Turkey name: Faruk Ayhan Başçiftçi, Dr role: CONTACT phone: 338-226-2082 email: dis@kmu.edu.tr name: Sümeyye Çelik Özsoy, Dr role: CONTACT phone: 338-226-2082 email: sumeyyecelik@kmu.edu.tr name: Doğan Ilgaz Kaya, Dr role: PRINCIPAL_INVESTIGATOR lat: 37.18111 lon: 33.215 hasResults: False

 nctId: NCT06318000 id: SN4/20/22 briefTitle: Physical Activity and Sports for People With Visual Impairments overallStatus: COMPLETED date: 2020-03-01 date: 2022-12-31 date: 2022-12-31 date: 2024-03-19 date: 2024-03-20 name: Józef Piłsudski University of Physical Education class: OTHER briefSummary: Purpose of this study was to assess the relationship between the visual impairment degree and the level of children's fundamental motor skills, balance and bilateral coordination. conditions: Blindness conditions: Visual Impairment studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 76 type: ACTUAL name: Balance test, bilateral coordination test, fundamental motor skills test measure: Center of pressure (CoP) path length was measured measure: Surface area of stabilogram was measured measure: Raw and scale score for each item measure: Qualitative performance criteria (points) measure: Body mass in kg measure: Body height in cm sex: ALL minimumAge: 7 Years maximumAge: 17 Years stdAges: CHILD facility: University of Physical Education city: Warsaw zip: 00-968 country: Poland lat: 52.22977 lon: 21.01178 hasResults: False

 nctId: NCT06317987 id: 2068557 id: P50DA054072 type: NIH link: https://reporter.nih.gov/quickSearch/P50DA054072 briefTitle: Addressing Barriers to Care for Substance Use Disorder Pilot Study acronym: ABCSUD Pilot overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-02 date: 2025-04-02 date: 2024-03-19 date: 2024-04-19 name: Kaiser Permanente class: OTHER name: National Institute on Drug Abuse (NIDA) name: Stanford University briefSummary: The Addressing Barriers to Care for Substance Use Disorder Pilot (ABC-SUD Pilot) is a randomized pilot study that will precede a larger trial. The ABC-SUD Pilot is a parallel group, cluster-randomized pilot feasibility trial, with clinicians (care coordinators) as the unit of randomization.

This study will be conducted in a mental health treatment access center within the Washington region of Kaiser Permanente. As part of usual care, patients contact the mental health access center and speak to a "care coordinator" to obtain contact information for potential venues to obtain treatment for substance use disorder.

The experimental intervention, Care Navigation, will be evaluated for its potential to increase the utilization of substance use disorder treatment among patients who contact the mental health treatment access center. The investigators note that Care Navigation will be delivered by study "care navigators", who are distinct from the health system's care coordinators. conditions: Drug Use Disorders conditions: Illicit Drug Use conditions: Alcohol-Related Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Care coordinators will be randomized to two parallel groups: usual care (UC; i.e., the comparator group) and usual care plus care navigation (UC + CN; i.e., the experimental group). All care coordinators will continue offering substance use resources and treatment options to patients as usual. Clinicians randomized to UC + CN will be able to offer and refer patients to a care navigator. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: All study outcomes are extracted from secondary data including electronic health record and healthcare claims databases whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Care Navigation measure: Rate of patient interest in care navigation measure: Feasibility of patient consent procedures measure: SUD treatment - 30 days measure: SUD treatment - 60 days measure: SUD treatment - 90 days measure: SUD treatment visits - 30 days measure: SUD treatment visits - 60 days measure: SUD treatment visits - 90 days measure: Days until SUD treatment utilization from clinical assessment appointment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06317974 id: 2022/210 briefTitle: The Effect of Breastfeeding Education on Breast Milk Perception and Self-Efficacy in the Pregnancy Health Belief Model overallStatus: COMPLETED date: 2022-06-30 date: 2022-12-31 date: 2023-02-15 date: 2024-03-19 date: 2024-03-19 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: Objective: The aim of this study was to evaluate the effect of breastfeeding education based on the Health Belief Model during the antenatal period on couples' perception and self-efficacy regarding breast milk. conditions: Breastfeeding Education studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled, experimental research design in pre-test, post-test design Made with primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 220 type: ACTUAL name: Breastfeeding education based on the Health Belief model measure: Mothers' and fathers' perception of breast milk, assessed using the Adults' Breast Milk Perception Scale. measure: Breastfeeding self-efficacy of mothers evaluated using the Breastfeeding Self-Efficacy Scale-Short Form during Pregnancy measure: Paternal breastfeeding self-efficacy assessed using the Paternal Breastfeeding Self-Efficacy Scale. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul University - Cerrahpasa city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06317961 id: INT200-22 briefTitle: Pilot Study on the Use of iENTER, iCONSENT and iPARTICIPATE E-tools overallStatus: RECRUITING date: 2023-04-05 date: 2025-01-31 date: 2025-01-31 date: 2024-03-19 date: 2024-03-19 name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano class: OTHER name: Vall d'Hebron Institute of Oncology name: The Netherlands Cancer Institute briefSummary: Precision oncology is the future of fighting cancer. Cancer Core Europe (CCE) developed a precision medicine trial, i.e. the Basket of Basket (BoB) study, to provide personalised treatment to a large number of patients by incorporating a molecular profiling platform. The EU-funded CCE_DART project, developed within the CCE Consortium, is aimed at improving efficiency and transform platform trials into data-rich translational research programmes. Within the CCE_DART project working area D "Patient involvement through information and partnership" three interconnected web e-tools were developed aimed at promoting patient information, recruitment, and involvement as well as facilitating adherence to the CCE BoB trial: 1) iENTER: informative web site addressed to potential BoB trial participants, their caregivers, patients' advocates, and the public; 2) iCONSENT: web app for remote management of the informed consent process in the CCE BoB trial.3) iPARTICIPATE: web app allowing remote access to BoB trial patients trial visits calendar, medications list and posology, to upload documents and download reports, messaging between patients and clinical staff. The main objective of this study is to carry out field testing and assess usability of the e-tools iENTER, iCONSENT and iPARTICIPATE. The study is also addressed at collecting patients' suggestions for improvements of the e-tools. conditions: Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: SUS questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Istituto Nazionale dei Tumori status: RECRUITING city: Milano zip: 20133 country: Italy name: Rosalba Miceli, PhD role: CONTACT phone: +39 0223903198 email: rosalba.miceli@istitutotumori.mi.it name: Sara Iadecola role: CONTACT phone: +39 0223903198 email: sara.iadecola@istitutotumori.mi.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06317948 id: IG23150 briefTitle: Improving the Quality of Radiotherapy by Multi-Institution Knowledge-Based Planning Optimization Models (Acronym: MIKAPOCo, Multi-Institutional Knowledge-based Approach in Plan Optimization for the Community) acronym: MIKAPOCo overallStatus: ENROLLING_BY_INVITATION date: 2022-10-28 date: 2022-10-28 date: 2025-10-28 date: 2024-03-19 date: 2024-03-20 name: IRCCS Ospedale San Raffaele class: OTHER briefSummary: Investigators central hypothesis is that it is possible to create libraries of "consistent" Knowledge-Based plan-models derived from large Institutional experiences. These libraries can be used to guide automated RT planning and serve as tools to assist centers for plan quality assurance (QA) and plan prediction.

Quantifying Inter-institute variability of RT planning and building libraries of interchangeable and validated multi-Institutional KB plan prediction models is expected to impact on the quality of planning at the national level. The project has the potential of facilitating the introduction of AI approaches in plan optimization, thus reducing intra and inter-Institute planning variability. Improving plan quality is expected to translate into better outcome after RT in terms of local control and, even more, of side effects and Quality of life. Positive impact is also expected in patient selection for advanced techniques, in plan audit and plan optimization in clinical trials, in technology comparison and cost-benefit analyses as well as in the RT educational field. conditions: Breast Cancer conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: treatment plan comparison measure: model interchangeability sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale San Raffaele city: Milano zip: 20133 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06317935 id: HU-ERG-BK-01 briefTitle: The Effect of Virtual Reality Application on Independence and Hand Functions in Daily Life in Children With CP overallStatus: NOT_YET_RECRUITING date: 2024-04-23 date: 2024-06-29 date: 2024-10-29 date: 2024-03-19 date: 2024-03-19 name: Hacettepe University class: OTHER name: Ankara Bilkent City Hospital briefSummary: The aim of this study is to evaluate the effect of virtual reality applications on the level of independence and upper extremity functionality perceived by children in daily life in children with hemipegic cerebral palsy.

The research is a randomized controlled, cross-over study. The sample group of the research is children diagnosed with hemiplegic cerebral palsy and families who are receiving inpatient treatment in the pediatric service of Ankara City Hospital Physical Therapy and Rehabilitation Hospital.

Two groups, intervention (A) and control (B), will be created from the target research group using the randomization method.

The upper extremity functionality of both research groups before the intervention will be evaluated with the 'Motor Activity Diary for Children' scale and the perceived independence level with the 'Children's Hand Use Experience' scale.

After the initial evaluation is completed, group A, represented as the intervention group, will receive ArmeoSenso virtual reality intervention in the upper extremity hand function laboratory for 3 weeks, 5 days a week, each session for 30 minutes, in addition to traditional occupational therapy and physiotherapy rehabilitation programs. Meanwhile, group B, represented as the control group, will continue the traditional occupational therapy and physiotherapy rehabilitation program. At the end of the third week of the intervention, tests measuring upper extremity functionality and perceived independence level will be repeated.

Measurement tools will be repeated at the beginning of the intervention, at the end of the 3rd week, and at the end of the intervention. conditions: Hemiplegic Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Two groups, intervention (A) and control (B), will be created from the target research group using the randomization method.

Intervention group (A) will receive virtual reality application for 30 minutes, 5 days a week for 3 weeks, in addition to traditional occupational therapy and physiotherapy approaches for the first 3 weeks, and will receive only traditional treatments between 3-6 weeks.

The control group (B) will receive only traditional occupational therapy and physiotherapy approaches for the first 3 weeks, and between 3-6 weeks, they will receive virtual reality application in addition to traditional approaches for 30 minutes, 5 days a week for 3 weeks. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 52 type: ESTIMATED name: ArmeoSenso name: Traditional Rehabilitation measure: The effect of virtual reality applications on perceived independence in daily life in hemiplegic CP. measure: The effect of virtual reality applications on upper extremity functionality in daily life in children with hemiplegic CP. measure: Dosimetry of virtual reality applications sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Ankara Bilkent City Hospital city: Multiple Locations state: Ankara zip: 06000 country: Turkey name: Başak Karadağ, MSc role: CONTACT phone: +905059462128 email: basakhacettepe@hotmail.com name: Berke Aras, Ass. Prof. role: CONTACT phone: +90365851518 email: drberkearas@gmail.com hasResults: False

 nctId: NCT06317922 id: DRYEYE-IVT Project briefTitle: Evaluation of Dry Eye Disease's Signs in Patients Who Were Administered Intravitreal Anti-VEGF Injections acronym: DRYEYE-IVT overallStatus: RECRUITING date: 2024-02-05 date: 2025-05-12 date: 2025-05-12 date: 2024-03-19 date: 2024-03-20 name: Francesco Bandello class: OTHER briefSummary: The goal of this interventional, monocentric, prospective, single-masked, case-control study is to evaluate the efficacy of Thealoz Duo (artificial tear containing trehalose 3 g and hyaluronic acid 0.15 g) in comparison to a saline solution (Hydrabak containing Sodium Chloride 0,9 g, Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate Dodecahydrate), to reduce the signs of ocular discomfort and ocular side effects in patients who have received Intravitreal injections.

The main questions it aims to answer are:

* can ocular instillation of Thealoz Duo solution, 1 week before intravitreal injection, in a fixed dose regimen, prevent ocular surface changes and dry-eye signs?
* can ocular instillation of Thealoz Duo solution, up 3 months after intravitreal injections, in a fixed dose regimen, reduce ocular surface changes, and dry-eye signs with improvement of quality of life and quality of vision?

Each participant will be randomized into each of two arms:

1. TREATMENT ARM: patients who will receive the instillation of Thealoz Duo, 10 ml, 1 drop, 4 times/day;
2. CONTROL ARM: patients who will receive the instillation of saline solution (Hydrabak), 10 ml, 1 drop, 4 times /day;

The decision of inclusion of a control group should minimize the risk of breaking the blinding condition by affecting the consistency and reliability of the outcome's achievement.

In any case, the instillation of saline solution should not alter the ocular surface. conditions: Dry Eye Syndromes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The participants will be randomized in two arms (treatment arm and control arm) in a ratio of 1:1. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: There are two teams:

1. MASKED TEAM: Sub-investigators and study coordinators delegated to perform the following tasks:

   * dispensation to the patient the Investigational medical device (Thealoz Duo) or saline solution (Hydrabak containing Sodium Chloride 0,9 g, Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate Dodecahydrate);
   * accountability of Investigational medical device and saline solution;
   * verify the compliance and therapeutic adherence of the patient;
   * discussion with the patient regarding the respect of the masked condition of the study;
2. UNMASKED TEAMS:

   * informed consent process;
   * to perform the follow-up visit and assessments provided to test the ocular surface. whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Thealoz Duo; name: sham (Hydrabak) measure: Administration of Ocular Surface Disease Index (OSDI) to the patient measure: administration of Visual Analog Scale for Pain to the patient measure: evaluation of matrix metalloproteinase 9 gene expression measure: TearLab Osmolarity measure: Schirmer's test measure: tear film Break Up Time (tBUT) measure: conjunctival hyperemia according to Efron grading scale measure: fluorescein staining sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale San Raffaele _O.U. Ophthalmology status: RECRUITING city: Milan zip: 20123 country: Italy name: Giulia Basile, MPharm role: CONTACT phone: +39 0226433545 email: basile.giulia@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06317909 id: 23-03 DONNER-2 briefTitle: Development of a Novel Non-invasive Inflammometry Following Allergen Challenge in Patients With Mild Allergic Asthma overallStatus: RECRUITING date: 2024-06-01 date: 2025-09 date: 2025-09 date: 2024-03-19 date: 2024-03-19 name: Fraunhofer-Institute of Toxicology and Experimental Medicine class: OTHER briefSummary: The goal of this exploratory method-development study is to to establish and evaluate novel non-invasive methods to monitor airway inflammation induced by allergen challenge (both by instillation during bronchoscopy and by inhalation) in patients with mild allergic asthma.

The investigator wants to further profile and develop the allergen challenge model by investigating the utility of various non-invasive monitoring methods. The hypothesis of the project is that local inflammatory changes in the lung induced by allergen can be captured by gas-enhanced magnetic resonance imaging (MRI) and analysis of exhaled breath.

The validation of cellular outcome measures and non-invasive inflammometry can be used in future clinical trials for proof of concept of novel anti-inflammatory medications.

Participants will undergo

* methacholine challenge
* 2 inhaled allergen challenges
* 2 MRI with hyperpolarized xenon and gadolinium based contrast agent
* 2 bronchoscopies with bronchoalveolar lavage (BAL)
* segmental allergen challenge during the first bronchoscopy
* spirometry
* skin prick test and skin prick dilution tests
* measurement of particles in exhaled air
* nasal filter
* nasal lavage
* sputum induction
* peak flow meter tests
* exhaled NO (nictric oxide)
* blood sampling (in total approx. 190 ml) conditions: Mild Allergic Asthma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 15 type: ESTIMATED name: allergen challenge measure: Exploratory (1. priority) Changes in soluble mediators [i.e. IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, INF-alpha, MMP-9, CXCL1, SP-D, albumin] in Bronchoalveolar lavage (BAL) after segmental allergen challenge measure: Exploratory (1. priority) Changes in soluble mediators [i.e. IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, NF-alpha, MMP-9, CXCL1, SP-D, albumin] in Sputum after inhalative allergen challenge measure: Exploratory (1. priority) Changes in non-invasive exhaled particles [i.e.IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, NF-alpha, MMP-9, CXCL1, SP-D, albumin]after inhalative allergen challenge measure: Exploratory (1. priority) Changes in non-invasive exhaled particles [i.e.IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, NF-alpha, MMP-9, CXCL1, SP-D, albumin]after segmental allergen challenge measure: Exploratory (1. priority) Changes in cell analyzation in BAL [i.e.total cells, neutrophil granulocytes, eosinophil granulocytes, basophil granulocytes, monocytes/macrophages, lymphocytes and dendritic cells] after segmental allergen challenge measure: Exploratory (1. priority) Changes in cell analyzation in Sputum [i.e.total cells, neutrophil granulocytes, eosinophil granulocytes, basophil granulocytes, monocytes/macrophages, lymphocytes and dendritic cells] after inhalative allergen challenge measure: Exploratory (2. priority) Detection of Ribonucleic acid (RNA) in exhaled particles measure: Exploratory (2. priority) Changes in Fractional exhaled nitric oxide (FeNO) after inhalative allergen challenge measure: Exploratory (2. priority) Changes in FeNO after segmental allergen challenge measure: Exploratory (2. priority) Quantification of regional ventilation, perfusion, and diffusion by magnetic resonance imaging (MRI) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fraunhofer Institute for Toxicology and Experimental Medicine status: RECRUITING city: Hannover state: Lower Saxony zip: 30625 country: Germany name: Jens M Hohlfeld role: CONTACT email: jens.hohlfeld@item.fraunhofer.de lat: 52.37052 lon: 9.73322 hasResults: False

 nctId: NCT06317896 id: 2024-KY-048-01 briefTitle: Value of Dynamic Monitoring of Early Recurrence of Hepatocellular Carcinoma After Radical Resection Based on CTCS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-19 date: 2024-03-19 name: Zhujiang Hospital class: OTHER briefSummary: On the basis of previous retrospective studies, the Task Force will further optimize the CTCs longitudinal surveillance model and initially validate the subclonal origin (CTC-DNA) of recurrent/metastatic foci derived from CTCs at the molecular level in hepatocellular carcinoma, prospective clinical trials will be conducted to further validate the predictive value of the CTCS longitudinal monitoring model in predicting postoperative recurrence of hepatocellular carcinoma, and to verify whether it is earlier than imaging to indicate recurrence, to explore the clinical feasibility of CTCs in guiding postoperative adjuvant therapy of liver cancer, and to provide new ideas for early intervention strategy of liver cancer after operation, to establish a set of standardized clinical scheme of auxiliary treatment for patients with liver cancer after operation for accurate and individualized"Early diagnosis and treatment". conditions: Hepatocellular Carcinoma conditions: Circulating Tumor Cell conditions: Recurrence conditions: Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 82 type: ESTIMATED name: circulating tumor cells measure: 2-year recurrence-free survival rate measure: Correlation between CTCs status dynamic changes and relapse measure: Correlation between metastasis，primary tumor and CTCs in blood through NGS and CTC-DNA sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Sixth Affiliated Hospital of South China University of Technology city: Foshan state: Guangdong country: China name: Weichao Liang, Prof. role: CONTACT phone: 13590542927 name: Weichao Liang role: PRINCIPAL_INVESTIGATOR lat: 23.02677 lon: 113.13148 facility: Zhujiang Hospital of Southern Medical University city: Guangzhou state: Guangdong zip: 510220 country: China name: Mingxin Pan, Prof. role: CONTACT phone: +8618928918216 email: pmxwxy@sohu.com name: Zhoubin Feng role: CONTACT phone: 19830551997 email: Fzbin1001@163.com name: Mingxin Pan, Prof. role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Affiliated Cancer Hospital and Institute of Guangzhou Medical University city: Guangzhou state: Guangdong country: China name: Yinbing Wu, Prof. role: CONTACT phone: 18620007296 name: Yinbing Wu role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06317883 id: CORALS briefTitle: Childhood Obesity Risk Assessment Longitudinal Study acronym: CORALS overallStatus: ACTIVE_NOT_RECRUITING date: 2019-05-27 date: 2032-07-14 date: 2032-07-14 date: 2024-03-19 date: 2024-03-19 name: Consorcio Centro de Investigación Biomédica en Red (CIBER) class: OTHER_GOV name: Instituto de Salud Carlos III name: Maimónides Biomedical Research Institute of Córdoba name: Universidad de Córdoba name: Institut Investigacio Sanitaria Pere Virgili name: University Rovira i Virgili name: Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición (CIBEROBN) briefSummary: Childhood obesity is a major public health problem worldwide. Europe has a high prevalence of obesity, which is accentuated in Mediterranean countries. Spain has a high prevalence of both overweight (percentage: 21.5 in boys and 22.2 in girls) and obesity (percentage: 10.6 in boys and 11.8 in girls) in children aged 6-9 years.

From childhood, obesity is associated with an increased risk of diseases such as insulin resistance, type 2 diabetes, hypertension, metabolic syndrome, musculoskeletal problems, sleep disorders and mental health problems. Obesity is a complex, multi-causal problem involving individual risk factors such as behavior and genetics. Behavioral factors include diet, physical activity, sedentary lifestyle, sleep, and others. It is therefore important to study each of the individual risk factors for obesity. There are few large sample studies in European/Spanish children and no longitudinal studies estimating the incidence of obesity in preschool children based on exposure to different risk factors, considering not only the effect of food consumption but also dietary habits and patterns.

The aim of the present study is to identify risk factors for childhood obesity through long-term longitudinal follow-up. conditions: Child Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1508 type: ACTUAL measure: Assessment of dietary intake and habits measure: Assessment of physical activity, sedentary behavior and sleep pattern measure: Early risk factors measure: Body composition: Height measure: Body composition: Weight measure: Body composition: Body mass index measure: Body composition: Waist circumference measure: Psychosocial and neuropsychological behavioral assessment measure: Verbal fluency measure: Muscular strength measure: Cardiorespiratory endurance measure: Association between genetic polymorphisms, metabolomic and metagenomic profiles with the development of obesity. measure: Body composition: Waist height measure: Body composition: Fat mass measure: Body composition: Fat mass index measure: Body composition: Fat-free mass measure: Body composition: Total body water measure: Systolic blood pressure measurement measure: Diastolic blood pressure measurement measure: Heart rate measurement measure: Hematological analysis: Hemoglobine measure: Hematological analysis: Hematocrite measure: Hematological analysis: Erythrocytes measure: Hematological analysis: Mean corpuscular volume measure: Hematological analysis: Mean corpuscular hemoglobin measure: Hematological analysis: Mean corpuscular hemoglobin concentration measure: Hematological analysis: Red cell blood distribution width measure: Hematological analysis: White blood cells measure: Hematological analysis: Neutrophils measure: Hematological analysis: Lymphocytes measure: Hematological analysis: Monocytes measure: Hematological analysis: Eosinophils measure: Hematological analysis: Basophiles measure: Hematological analysis: Platelets measure: Hematological analysis: Mean platelet volume measure: Biochemical analysis: Glucose measure: Biochemical analysis: Bilirubin measure: Biochemical analysis: Creatinine measure: Biochemical analysis: Urate measure: Biochemical analysis: Urea measure: Biochemical analysis: Total protein measure: Biochemical analysis: Aspartate aminotransferase measure: Biochemical analysis: Alanine aminotransferase measure: Biochemical analysis: Gamma-glutamyl transferase measure: Biochemical analysis: Alkaline phosphatase measure: Biochemical analysis: Total cholesterol measure: Biochemical analysis: High density lipoproteins measure: Biochemical analysis: Non-HDL cholesterol measure: Biochemical analysis: Low density lipoproteins measure: Biochemical analysis: Apolipoprotein A1 measure: Biochemical analysis: Apolipoprotein B measure: Biochemical analysis: Calcium measure: Biochemical analysis: Potassium measure: Biochemical analysis: Sodium measure: Biochemical analysis: Phosphorus measure: Biochemical analysis: Iron measure: Biochemical analysis: Magnesium measure: Biochemical analysis: Zinc measure: Biochemical analysis: Insulin measure: Biochemical analysis: Insulin resistance measure: Biochemical analysis: C-reactive protein measure: Biochemical analysis: Tumor necrosis factor alpha measure: Biochemical analysis: Adiponectin measure: Biochemical analysis: Energy measure: Biochemical analysis: Carbohydrates measure: Biochemical analysis: Sugars measure: Biochemical analysis: Fiber measure: Biochemical analysis: Polysaccharides measure: Biochemical analysis: Total fat measure: Biochemical analysis: Saturated fatty acids measure: Biochemical analysis: Monounsaturated fatty acids measure: Biochemical analysis: Polyunsaturated fatty acids measure: Biochemical analysis: Vitamin B1 measure: Biochemical analysis: Vitamin B2 measure: Biochemical analysis: Vitamin B3 measure: Biochemical analysis: Vitamin B6 measure: Biochemical analysis: Vitamin B9 measure: Biochemical analysis: Vitamin B12 measure: Biochemical analysis: Vitamin C measure: Biochemical analysis: Vitamin A measure: Biochemical analysis: Vitamin D measure: Biochemical analysis: Vitamin E measure: Biochemical analysis: Carotenes measure: Biochemical analysis: Retinol measure: Biochemical analysis: Water sex: ALL minimumAge: 3 Years maximumAge: 6 Years stdAges: CHILD facility: University of Santiago de Compostela city: Santiago De Compostela state: La Coruña zip: 15782 country: Spain lat: 42.88052 lon: -8.54569 facility: University of Navarra city: Pamplona state: Navarra zip: 31009 country: Spain lat: 42.81687 lon: -1.64323 facility: Institut Hospital del Mar d'Investigacions Mèdiques city: Barcelona zip: 08003 country: Spain lat: 41.38879 lon: 2.15899 facility: University of Cordoba city: Córdoba zip: 14071 country: Spain lat: 37.89155 lon: -4.77275 facility: Rovira i Virgili University city: Tarragona zip: 43002 country: Spain lat: 41.11667 lon: 1.25 facility: University of Valencia city: Valencia zip: 46010 country: Spain lat: 39.46975 lon: -0.37739 facility: University of Zaragoza city: Zaragoza zip: 50018 country: Spain lat: 41.65606 lon: -0.87734 hasResults: False

 nctId: NCT06317870 id: CHUV_PENGIT briefTitle: Pericapsular Nerve Block Versus Intrathecal Morphine for Analgesia After Primary Hip Arthroplasty acronym: PENGIT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-01-01 date: 2027-05-01 date: 2024-03-19 date: 2024-03-19 name: Centre Hospitalier Universitaire Vaudois class: OTHER briefSummary: The aim of this clinical trial is to compare the analgesic effect of pericapsular nerve block (PENG) with intrathecal morphine in patients scheduled for total hip replacement surgery. The main question to be answered is whether the PENG block is equivalent to intrathecal morphine in reducing postoperative pain.

Participants will be randomised into two groups. Patients assigned to the PENG group will receive spinal anaesthesia with local anaesthetic (isobaric bupivacaine) alone and a PENG block. Patients assigned to the intrathecal morphine (ITM) group will receive spinal anaesthesia with a mixture of local anaesthetic (isobaric bupivacaine) and morphine (100 mcg) and a sham PENG block to ensure patient blinding. conditions: Analgesia conditions: Hip Arthropathy conditions: Post Operative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: single centered, prospective, double blinded non inferiority trial primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: quadruple whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Intrathecal morphine name: Pericapsular nerve group block (PENG) measure: Cumulative postoperative morphine consumption at day 1 measure: Morphine consumption in the recovery room measure: PCA administered morphine consumption at day 2 measure: rest and dynamic pain scores measure: Incidence of postoperative nausea and vomiting measure: Incidence of pruritus measure: Incidence of urinary retention requiring bladder catheterisation measure: Duration of analgesia measure: operated limb quadriceps strength measure: Walking test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital of Lausanne city: Lausanne state: Vaud zip: 1011 country: Switzerland name: Marta Szyszko du Bois d'Aische role: CONTACT phone: +41795564002 email: marta.szyszko@chuv.ch name: Corey Kull role: CONTACT phone: +41795561781 email: corey.kull@chuv.ch lat: 46.516 lon: 6.63282 hasResults: False

 nctId: NCT06317857 id: 14422021443228 briefTitle: Clinical Performance of an Alkasite-based Restorative Material overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-06-30 date: 2025-06-30 date: 2024-03-19 date: 2024-03-19 name: Cairo University class: OTHER briefSummary: The evolution of restorative dental materials and technology has enabled the use of tooth-colored restorative materials in dental restorations, with all dentists hoping for the presence of materials that combine biocompatible qualities and aesthetics . Although resin composite materials' mechanical and aesthetic properties have greatly improved over the past 20 years, research is currently on to find ways to prevent secondary caries from forming beneath and at the margins of restorations. In order to circumvent these problems, there is a growing tendency towards the use of resin-based bioactive and remineralizing restorative materials to strengthen and lengthen the lifespan of bonded dental restorations. conditions: Caries, Dental studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Centio Forte measure: Retention success rate % with modified USPH criteria measure: Marginal adaptation with modified USPH criteria marginal discolouration, recurrent caries, anatomic form and postoperative sensitivity. measure: Postoperative sensitivity sex: ALL minimumAge: 16 Years maximumAge: 55 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06317844 id: BlackHillsHealthPsych id: P20GM103443 type: NIH link: https://reporter.nih.gov/quickSearch/P20GM103443 briefTitle: Examination of Psychological and Physiological Pathways Linking Gratitude and Pain overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-08 date: 2027-05 date: 2024-03-19 date: 2024-03-19 name: Black Hills State University class: OTHER name: National Institute of General Medical Sciences (NIGMS) briefSummary: The goal of this clinical trial is to compare the effects of a brief gratitude intervention on individuals' psychological and physiological responses to acute pain. Furthermore, these associations will be examined in the context of genetic variations associated with both pain and psychological processes. conditions: Acute Pain conditions: Positive Thinking conditions: Emotions studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 300 type: ESTIMATED name: Behavioral Writing Intervention measure: Change in Subjective Pain Ratings from Baseline to 10-minutes Post Cold Pressor Test measure: Differences in Pain Tolerance to Cold Pressor Test measure: Differences in Pain Onset to Cold Pressor Test measure: Differences in Pain-Related Cognition measure: Differences in Autonomic Nervous System Responsivity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06317831 id: 2023.03936.BDANA briefTitle: LetS Get fUnctional! FuNctional Status in pEople With intersTitial Lung Disease acronym: SUNSET overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-12-30 date: 2028-07-30 date: 2024-03-19 date: 2024-03-19 name: Aveiro University class: OTHER name: Fundação para a Ciência e a Tecnologia briefSummary: This study aims to i) To characterize the functional status and explore the determinants of functional status decline of people with IlD ii)To determine the measurement properties of functional status instruments in people with Interstitial lung diseases (ILD) iii) To identify the impact of ILD and the participants' perspectives on functional status through interviews iv) Explore the progression of functional status progression in people with ILD and v) Develop a multidimensional index, incorporating functional status parameters, to predict mortality in people with ILD.

Patients with ILD will be recruited via the pulmonology services at hospitals, namely from Centro Hospitalar de Vila Nova de Gaia/Espinho (CHVNG/E), Centro Hospitalar do Baixo Vouga (CHBV) and Centro Hospitalar de Entre o Douro e Vouga (CHEDV). Sociodemographic, clinical characteristics (i.e., smoking habits, vital signs and symptoms), anthropometric (i.e., height and weight to compute body mass index) and general clinical data (i.e., medication, oxygen therapy, non-invasive ventilation, acute exacerbations, hospitalizations and number of hospital admissions in the last month and year, length of stay), as well as prior and follow-up spirometric measurements and arterial blood gas will be collected from clinical records for patients' characterization. Mortality and rehospitalizations will be explored during the study period. Peripheral muscle strength, functional status, daily physical activity, self-reported symptoms, functional status, impact of the disease and health-related quality of life. Qualitative data from interviews.

The assessments will be conducted at 6 time points: baseline and 1 week after for instrument validation, followed by assessments every 6 months for 2 years.

It is expected that: i) Functional status limitations can be comprehensively identified and measured in individuals with ILD. ii) Some measures are valid and reliable indicators of functional status in individuals with ILD. iii) Different profiles of functional status progression will be identified in individuals with ILD, including stable, slow, and fast decline. iv) A multidimensional index incorporating functional status will improve the accuracy of predicting mortality and outperform the predictive ability of the current GAP Index. conditions: Interstitial Lung Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED measure: Short physical performance battery (SPPB) measure: Six Minute Walk Test (6MWT) measure: The 1-minute sit-to-stand measure: The grocery shelving task measure: The Physical Performance Test (PPT) measure: Handgrip strenght measure: Peripheral muscle strength measure: The Tilburg Frailty Indicator (TFI) measure: The Canadian Occupational Performance Measure (COPM) measure: Symptoms of fatigue measure: Symptoms of fatigue measure: Symptoms of dyspnoea measure: The Pulmonary Functional Status and Dyspnea Questionnaire Modified version (PFSDQ-M) measure: Health-related quality of life (HRQOL) measure: Health-related quality of life (HRQOL) measure: London Chest Activities of Daily Living (LCADL) measure: Daily physical activity measure: Qualitative data: Interviews measure: Number of hospitalizations measure: Acute exacerbations measure: Non-invasive ventilation measure: Oxygen therapy measure: Medication measure: Mortality measure: Weight measure: Height measure: Body mass index measure: Heart rate measure: Respiratory rate measure: Blood pressure measure: Peripheral Oxygen Saturation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Aveiro city: Aveiro zip: 3810-193 country: Portugal lat: 40.64427 lon: -8.64554 hasResults: False

 nctId: NCT06317818 id: TJT2301 briefTitle: Is Local Injection of Mesenchymal Stem Cells After Endoscopic Dilation Safe and Does it Improve the Outcome of Intestinal Stricture in Patients With Crohn's Disease? overallStatus: RECRUITING date: 2023-06-06 date: 2025-08 date: 2025-08 date: 2024-03-19 date: 2024-03-19 name: Centre Hospitalier Universitaire de Liege class: OTHER briefSummary: This is an exploratory phase II study, to evaluate the impact of these Mesenchymal Stem Cells (MSCs) on strictures in Crohn's disease patients with symptomatic intestinal stricture eligible to endoscopic dilatation. The impact of combined treatment by endoscopic dilation and local injection of MSCs will be compared with that of a control group. conditions: Safety Issues conditions: Efficacy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, double-blind, controlled study primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Mesenchymal Stem Cells name: Comparative placebo measure: Assessment of safety of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease. measure: Assessment of efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease by evaluating symptomatic clinical response measure: Assessment of efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease by evaluating endoscopic response measure: Assessment of efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease by evaluating radiological response measure: Evaluation of studying, in addition to biomarkers (CRP and fecal calprotectin), sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Liège status: RECRUITING city: Liège zip: 4000 country: Belgium name: Sophie Vieujean, MD role: CONTACT phone: + 32 4 323 72 56 email: s.vieujean@chuliege.be name: Layla Boutaffala role: CONTACT phone: +32 4 323 38 10 email: lboutaffala@chuliege.be lat: 50.63373 lon: 5.56749 hasResults: False

 nctId: NCT06317805 id: TREV1-10P.401 id: 2023-504351-26-01 type: CTIS briefTitle: Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients acronym: TripleTRE overallStatus: RECRUITING date: 2023-12-06 date: 2027-06 date: 2027-06-30 date: 2024-03-19 date: 2024-03-19 name: AOP Orphan Pharmaceuticals AG class: INDUSTRY name: ANOVA CRO s.r.o. name: PharmaLex Belgium name: Aixial s.r.o. name: GCP-Service International Ltd. & Co. KG briefSummary: TripleTRE investigates the effect of initial triple combination therapy (oral endothelin receptor antagonist (ERA) + oral phosphodiesterase tyüe-5 inhibitor (PDE-5i) + parenteral treprostinil) compared to double oral therapy (oral ERA + oral PDE-5i) in pulmonary arterial hypertension (PAH) patients (group I) with intermediate-high risk or patients with intermediate-low risk with severe hemodynamic impairment at baseline in a prospective, randomized, unblinded setting with scope of increasing evidence for optimization of therapy concepts in PAH.

The effect of initial triple combination therapy vs initial double oral therapy (standard of care (SoC)) will be measured by primary endpoint: (non)response to the assigned treatment. conditions: Pulmonary Arterial Hypertension studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomized, two-arm, open-label, low-interventional, phase IV, multi-centre clinical trial comparing efficacy and safety of initial triple therapy including parenteral treprostinil to initial double oral therapy (background therapy with endothelin receptor antagonist - ERA and phosphodiesterase type-5 inhibitor - PDE-5i) by proportion of patients achieving low risk status according to the simplified four-strata risk-assessment tool from week 24 up to 48 weeks in 110 (55/group) treatment-naïve adult intermediate-high risk or intermediate-low risk patients with severe hemodynamic impairment with pulmonary arterial hypertension (PAH) (group I). primaryPurpose: TREATMENT masking: NONE count: 110 type: ESTIMATED name: Generic treprostinil sodium + Standard of Care (Double Oral) name: Standard of Care - Double Oral measure: Patients achieving (non-)response status to the assigned treatment in terms of achievement of low-risk status measure: Change in hemodynamic parameters by means of right heart catheterization (RHC) - PVR measure: Change in hemodynamic parameters by means of right heart catheterization (RHC) - mPAP measure: Change in hemodynamic parameters by means of right heart catheterization (RHC) - mRAP measure: Change in hemodynamic parameters by means of right heart catheterization (RHC) - CI measure: Change in hemodynamic parameters by means of right heart catheterization (RHC) - CO measure: Change in hemodynamic parameters by means of right heart catheterization (RHC) - RAP measure: Change in right heart structure and function assessed by echocardiography - TAPSE/sPAP measure: Change in right heart structure and function assessed by echocardiography - RVEDA measure: Change in right heart structure and function assessed by echocardiography - RVESA measure: Change in right heart structure and function assessed by echocardiography - RVFAC measure: Change in right heart structure and function assessed by echocardiography - RA measure: Change in right heart structure and function assessed by echocardiography - Pericardial effusion measure: Time to achievement of low-risk status measure: Rate of change of risk status measure: Change in the number of low-risk criteria based on the French PH Network Registry (FPHR) risk assessment tool measure: Change in REVEAL 2.0 risk score measure: Rate of change in WHO-FC measure: Rate of change in 6MWD measure: Rate of change in NT-proBNP/BNP levels measure: Total number of clinical worsening(s) measure: Overall and transplant free survival measure: Rate of change in quality of life - emPHasis-10 measure: Rate of change in quality of life - EQ-5D-5L measure: Safety outcomes: sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ordensklinikum Linz status: RECRUITING city: Linz country: Austria name: Regina Steringer-Mascherbauer role: CONTACT phone: +437327676 phoneExt: 4916 email: regina.steringer-mascherbauer@ordensklinikum.at name: Regina Steringer-Mascherbauer role: PRINCIPAL_INVESTIGATOR lat: 48.30639 lon: 14.28611 facility: Medical University Vienna status: RECRUITING city: Vienna country: Austria name: Irene Lang role: CONTACT phone: +43140400 phoneExt: 4623 email: irene.lang@meduniwien.ac.at name: Irene Lang role: PRINCIPAL_INVESTIGATOR lat: 48.20849 lon: 16.37208 facility: Fakultní Nemocnice Olomouc status: NOT_YET_RECRUITING city: Olomouc country: Czechia name: Jan Přeček role: CONTACT phone: +420588445102 email: jan.precek@fnol.cz name: Jan Přeček role: PRINCIPAL_INVESTIGATOR lat: 49.59552 lon: 17.25175 facility: Všeobecná fakultní nemocnice v Praze status: NOT_YET_RECRUITING city: Praha country: Czechia name: Pavel Jansa role: CONTACT phone: +420224962629 email: pavel.jansa@vfn.cz name: Pavel Jansa role: PRINCIPAL_INVESTIGATOR lat: 50.08804 lon: 14.42076 facility: Hôpital Bicêtre-- Assistance Publique Hopitaux de Paris status: NOT_YET_RECRUITING city: Paris country: France name: Olivier Sitbon role: CONTACT phone: +33145217883 email: olivier.sitbon@abc.aphp.fr name: Olivier Sitbon role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hôpitaux Universitaires de Strasbourg status: NOT_YET_RECRUITING city: Strasbourg country: France name: Marianne Riou role: CONTACT phone: +330369550686 email: marianne.riou@chru-strasbourg.fr name: Marianne Riou role: PRINCIPAL_INVESTIGATOR lat: 48.58392 lon: 7.74553 facility: DRK Kliniken Berlin Westend status: NOT_YET_RECRUITING city: Berlin country: Germany name: Christian Opitz role: CONTACT phone: +493030354815 email: c.opitz@drk-kliniken-berlin.de name: Christian Opitz role: PRINCIPAL_INVESTIGATOR lat: 52.52437 lon: 13.41053 facility: University Hospital Carl Gustav Carus of Technical University Dresden status: NOT_YET_RECRUITING city: Dresden country: Germany name: Michael Halank role: CONTACT phone: +4935145813981 email: michael.halank@uniklinikum-dresden.de name: Michael Halank role: PRINCIPAL_INVESTIGATOR lat: 51.05089 lon: 13.73832 facility: Universitätsmedizin Greifswald status: NOT_YET_RECRUITING city: Greifswald country: Germany name: Ralf Ewert role: CONTACT phone: +4938348680500 email: ewert@uni-greifswald.de name: Ralf Ewert role: PRINCIPAL_INVESTIGATOR lat: 54.09311 lon: 13.38786 facility: Gottsegen National Cardiovascular lnstitute status: NOT_YET_RECRUITING city: Budapest country: Hungary name: Olga Hajnalka Balint role: CONTACT phone: +3612152139 email: titkarsag@kardio.hu name: Olga Hajnalka Balint role: PRINCIPAL_INVESTIGATOR lat: 47.49801 lon: 19.03991 facility: Medical University of Szeged status: NOT_YET_RECRUITING city: Szeged country: Hungary name: Gergely Ágoston role: CONTACT phone: +3662545553 email: agoston.gergely@med.u-szeged.hu name: Gergely Ágoston role: PRINCIPAL_INVESTIGATOR lat: 46.253 lon: 20.14824 facility: Sapienza University of Rome status: RECRUITING city: Rome country: Italy name: Roberto Badagliacca role: CONTACT phone: +39064402727 email: roberto.badagliacca@uniroma1.it name: Roberto Badagliacca role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 facility: John Paul II Hospital Krakow status: NOT_YET_RECRUITING city: Kraków country: Poland name: Grzegorz Kopeć role: CONTACT phone: +48126143399 name: Grzegorz Kopeć role: PRINCIPAL_INVESTIGATOR lat: 50.06143 lon: 19.93658 facility: Fryderyk Chopin Hospital in European Health Centre Otwock status: NOT_YET_RECRUITING city: Otwock country: Poland name: Marcin Kurzyna role: CONTACT phone: +48227103052 email: marcin.kurzyna@ecz-otwock.pl name: Marcin Kurzyna role: PRINCIPAL_INVESTIGATOR lat: 52.10577 lon: 21.26129 facility: Centro Hospitalar Lisboa Norte - Santa Maria University Hospital status: NOT_YET_RECRUITING city: Lisboa country: Portugal name: Rui Miguel Freire Plácido role: CONTACT phone: +351217805306 email: rui.placido@chln.min-saude.pt name: Rui Miguel Freire Plácido role: PRINCIPAL_INVESTIGATOR lat: 38.71667 lon: -9.13333 facility: Emergency Institute for Cardiovascular Diseases Prof. Dr. C.C.Iliescu status: NOT_YET_RECRUITING city: Bucharest country: Romania name: Ioan Mircea Coman role: CONTACT phone: +40213175222 name: Ioan Mircea Coman role: PRINCIPAL_INVESTIGATOR lat: 44.43225 lon: 26.10626 facility: Emergency Clinical County Hospital of Targu Mures status: NOT_YET_RECRUITING city: Târgu-Mureş country: Romania name: Ioan Tilea role: CONTACT phone: +40265215551 email: ioan.tilea@umfst.ro name: Ioan Tilea role: PRINCIPAL_INVESTIGATOR lat: 46.54245 lon: 24.55747 facility: Hospital Clinic of Barcelona status: NOT_YET_RECRUITING city: Barcelona country: Spain name: Isabel Blanco Vich role: CONTACT phone: +34932275779 email: iblanco2@clinic.cat name: Isabel Blanco Vich role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Hospital Ramon y Cajal status: NOT_YET_RECRUITING city: Madrid country: Spain name: Jose Andres Tenes Mayen role: CONTACT phone: +34913368263 email: jtenes@salud.madrid.org name: Jose Andres Tenes Mayen role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06317792 id: 202201719B0 briefTitle: The Efficacy of Online Exergaming-Integrated Physiotherapy for Parkinson's Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-31 date: 2026-06-30 date: 2024-03-19 date: 2024-03-19 name: Chang Gung Memorial Hospital class: OTHER name: National Science and Technology Council briefSummary: To validate the efficiency of online exergaming-based physiotherapy. We will enroll patients with Parkinson's disease in postural instability and gait disturbance motor phenotype in the study and divide them into two groups in a randomized controlled study. conditions: Parkinsonism in Diseases Classified Elsewhere studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be divided into two groups in a randomized controlled study primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: online exergaming-based physiotherapy programs measure: Unified Parkinson's Disease Rating Scale score assessment measure: Tinetti balance and gait score assessment measure: Fall Risk assessment using Berg Balance Scale measure: Depression severity assessment sex: ALL minimumAge: 20 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine city: Kaohsiung zip: 83304 country: Taiwan lat: 22.61626 lon: 120.31333 hasResults: False

 nctId: NCT06317779 id: abdominal laparotomy briefTitle: Evaluation of Laparoscopic Cholecystectomy and Concomitant Paraumbilical Hernia Repair overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-02-01 date: 2027-03-01 date: 2024-03-19 date: 2024-03-19 name: Assiut University class: OTHER briefSummary: Umbilical hernia frequently accompanies cholelithiasis. It is possible to repair these hernias after completing cholecystectomy. conditions: Abdominal Disorder studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED measure: Evaluation of Laparoscopic cholecystectomy and concomitant paraumbilical hernia repair measure: Secondary outcomes measures sex: ALL minimumAge: 10 Years maximumAge: 90 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06317766 id: UC 20-2023 briefTitle: Histological Study of the Effects of a 2910 nm Fiber Laser Technology overallStatus: ENROLLING_BY_INVITATION date: 2024-02-05 date: 2024-04 date: 2024-05 date: 2024-03-19 date: 2024-03-19 name: FA Corporation class: INDUSTRY name: University of Texas Southwestern Medical Center briefSummary: The goal of this interventional clinical study is to conduct a comprehensive evaluation of the 2910 nm fiber laser focusing on its diverse energy settings. 2 subjects will be recruited for this 2 part histology study. The main This study will provide valuable insights into the device\&#39;s capabilities and expand knowledge of its clinical utility. The first part of this study is intended to optimize treatment parameters based on observed effects at the molecular level. The second part will investigate the state of tissue at different timepoints following treatment.

Part 1 Pre-Clinical Study Procedure:

* 1 healthy adult (male or female)
* 18-75 years of age, who are scheduled to undergo an abdominoplasty (where abdominal skin will be excised) will be recruited.
* Informed consent will be obtained by a delegated member of the study staff prior to the day of surgery.
* On the day of the scheduled procedure, the laser device will be applied to the skin that will be removed as part of the surgery. The treatment will be completed after induction and prior to prepping for the surgical procedure.

Part 2 Clinical Study Procedure:

* 1 healthy adult (male or female)
* 18-75 years of age, who are scheduled to undergo an abdominoplasty (where abdominal skin will be excised) will be recruited.
* Informed consent will be obtained by a delegated member of the study staff prior to the day of surgery.
* The study team will utilize the specific setting based off the results of Part 1.
* Subject will be asked to return to the site on days -30, -3, -2, -1 before their procedure.
* At each visit, subjects will receive a single pulse treatment in areas that will be marked by the study team.
* On the day of their procedure, a member of the study team will administer 1 final pulse immediately post-surgery and all 5 timepoints will be harvested for analysis. conditions: Skin Laxity studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 2 type: ESTIMATED name: 2910 nm Fiber Laser Treatment; Pre-Clinical Histology Evaluation name: 2910 nm Fiber Laser Treatment; Part 2 Histology Evaluation measure: TUNEL Staining measure: Mason's Trichrome sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UT Soutwestern Medical Center city: Dallas state: Texas zip: 75390 country: United States lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06317753 id: UMinho1 briefTitle: Can Exercise Rewire the Brain Addiction Circuitry? acronym: REWIRED overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2027-12 date: 2027-12 date: 2024-03-19 date: 2024-03-22 name: University of Minho class: OTHER briefSummary: The aim of the present study is to apply neuroimaging techniques to investigate how physical exercise may influence the addiction circuitry, ultimately reducing alcohol consumption and craving in youth binge drinkers. This proposal will advance knowledge on how exercise may modulate the neurocircuitry of addiction. Uncovering the neurobiological mechanisms underlying the interactive neural effects of exercise and alcohol intake may provide additional scientific insights for the development of preventive and intervention programs for youth BD and AUD. conditions: Physical Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The protocol includes a randomized controlled trial with a follow-up at three months involving three groups of adolescents (18-24 Y) -experimental group 1, will be enrolled in the Aerobic program, experimental group 2 will be involved in the agility program, and an active control group that will be participating in a stretching program. Participants will be randomly assigned to each group. primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: Aerobic Exercise name: Agility-Cognitive Exercise name: Stretching/relaxation measure: Behavioral: alcohol consumption measure: Behavioral: binge episodes measure: Behavioral : drunkenness measure: Psychological (craving levels) measure: Brain structure measure: Brain structural connectivity- FA measure: Brain structural connectivity - MD measure: Brain structural connectivity - AD measure: Brain structural connectivity - RD measure: Brain function measure: Brain function-resting state measure: Monetary Incentive Delay Task (included in the fMRI paradigm) - hits measure: Monetary Incentive Delay Task (included in the fMRI paradigm) - reaction time measure: Maximal oxygen consumption (VO2max) measure: Brain-derived neurotrophic factor (BDNF) measure: Dopamine sex: ALL minimumAge: 18 Years maximumAge: 24 Years stdAges: ADULT hasResults: False

 nctId: NCT06317740 id: 0306369 briefTitle: Green Management Intervention Program For Nurse Managers overallStatus: COMPLETED date: 2023-04-01 date: 2023-12-31 date: 2023-12-31 date: 2024-03-19 date: 2024-03-19 name: Matrouh University class: OTHER briefSummary: Green management is the organization-wide strategy that aims to integrate environmental sustainability development into organizational management procedures for maintaining safety and striving high quality of care. The study aimed to examine the effect of a randomized trial of a green management intervention program on nurse manager outcomes. conditions: Intervention conditions: Knowledge, Attitudes, Practice studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized controlled trial using two-group pretest-posttest designs primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: The study was carried out as a randomized controlled trial using two-group pretest-posttest designs in which the intervention group received an intervention program, in contrast to the comparison group. The study design of the present work followed the CONSORT 2010statement whoMasked: PARTICIPANT count: 200 type: ACTUAL name: green management intervention program measure: Questionnaire to measure nurse managers' knowledge measure: Questionnaires to measure nurse manager outcomes sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Nursing, Matrouh University city: Marsa Matruh zip: 002 country: Egypt lat: 31.3529 lon: 27.23725 hasResults: False

 nctId: NCT06317727 id: IRAS 337105 briefTitle: PULSed Field ablAtion of coloRectal Polyps acronym: PULSAR overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-11 date: 2030-05 date: 2024-03-19 date: 2024-03-19 name: King's College Hospital NHS Trust class: OTHER name: Mirai Medical briefSummary: The goal of this observational study is to learn about the role of electroporation (the use of small electric pulses applied to tissue) in the treatment (ablation) of colorectal polyps. The main questions to answer in this pilot phase of the study are:

1. The safety of pulsed field ablation (PFA) for the removal of colorectal polyps
2. The efficacy and feasibility of PFA in the treatment of colorectal polyps using metrics such as treatment coverage, treatment time, post treatment fibrosis, post treatment recurrence and patient satisfaction conditions: Colon Polyp studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Irreversible Electroporation using EndoVE(Endoscopic Vacuum Electrode) and electrical pulses generated using ePORE(electroporation device) measure: Incidence of Treatment-Emergent Adverse Events measure: Efficacy of pulsed field ablation in the treatment of colorectal polyps measure: Efficacy of pulsed field ablation in the treatment of colorectal polyps measure: Efficacy of pulsed field ablation in the treatment of colorectal polyps measure: Efficacy of pulsed field ablation in the treatment of colorectal polyps measure: Efficacy of pulsed field ablation in the treatment of colorectal polyps measure: Efficacy of pulsed field ablation in the treatment of colorectal polyps measure: Evaluation of Quality of Life following pulsed field ablation treatment of colorectal polyps sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06317714 id: IR-2023/0002 id: 2023-A02233-42 type: OTHER domain: ANSM briefTitle: Long-term Follow-up and Quality of Life of Patients Treated With Anticancer Drugs acronym: THERAPINNOV overallStatus: RECRUITING date: 2024-03-08 date: 2027-03-08 date: 2027-03-08 date: 2024-03-19 date: 2024-03-19 name: Institut Rafael class: OTHER briefSummary: Currently, aspects related to the effects of anticancer treatments and the quality of life of patients and their needs are still poorly documented at the Rafael Institute. Thus this study will meet a dual objective: (1) the establishment of a registry to collect data on the safety and effectiveness of innovative and expensive anticancer drugs when administered in real life and (2) a measurement quantitative quality of life of patients treated with these drugs. conditions: Oncology conditions: Quality of Life conditions: Symptoms and Signs studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: questionnaires measure: overall survival measure: progression free survival measure: incidence of adverse events measure: incidence of serious adverse events measure: Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire Core 30 (QLQ-C30) Score measure: change from baseline in quality of life measured with the EQ5D5L questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute Rafaël status: RECRUITING city: Levallois Perret state: Institut Rafael zip: 92300 country: France name: Alain Toledano role: CONTACT phone: 33 (0)1 47 58 05 96 lat: 48.89389 lon: 2.28864 hasResults: False

 nctId: NCT06317701 id: IRB23-1801 briefTitle: Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation overallStatus: RECRUITING date: 2024-04-04 date: 2028-04 date: 2028-04 date: 2024-03-19 date: 2024-04-09 name: University of Chicago class: OTHER briefSummary: The purpose of this study is to determine if the treatment of Obstructive sleep apnea (OSA) by hypoglossal nerve stimulation (HGNS) will alter glucose metabolism. The study team will also determine if the treatment of Obstructive sleep apnea (OSA) by (hypoglossal nerve stimulation) HGNS will alter predictors of cardiovascular outcomes. conditions: Obstructive Sleep Apnea studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Hypoglossal Nerve Stimulation (HGNS) measure: Glycemic variability measure: Mean systolic BP (daytime and nocturnal) measure: Glycemic variability measure: mean blood glucose levels measure: mean ambulatory glucose excursions measure: time blocks measure: Morning fasting insulin, including calculated insulin resistance (HOMA-IR) measure: Mean norepinephrine levels measure: Morning fasting blood glucose measure: Hemoglobin A1c measure: Insulin levels measure: c-peptide levels measure: fasting lipid profile (triglycerides) measure: heart rate indices by activity monitor measure: sympathetic activity by plasma norepinephrine measure: Morning fasting insulin of c-peptide level measure: fasting lipid profile (HDL- cholesterol) measure: fasting lipid profile ( LDL-cholesterol) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Chicago status: RECRUITING city: Chicago state: Illinois zip: 60637 country: United States name: Phillip LoSavio, MD, MS role: CONTACT phone: 773-702-5189 email: Phillip.Losavio@bsd.uchicago.edu name: Leila Yazdanbakhsh role: CONTACT phone: 773-834-5087 email: leila.yazdanbakhsh@bsd.uchicago.edu name: Phillip LoSavio, MD, MS role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06317688 id: TWU IRB-FY2023-157 briefTitle: Effectiveness of Highly Purified Anhydrous (HPA) Lanolin Versus Extra-Virgin Coconut Oil in Preventing Subacute Lactation Mastitis overallStatus: ENROLLING_BY_INVITATION date: 2023-11-06 date: 2024-08-14 date: 2024-08-14 date: 2024-03-19 date: 2024-03-27 name: Texas Woman's University class: OTHER name: Harris Health System (Houston, Texas) briefSummary: Problem of the Study This study was designed to test the effectiveness of the application of extra-virgin coconut oil versus Highly Purified Anhydrous (HPA) Lanolin in ameliorating nipple pain, cracking and eventually the prevention of subacute lactation mastitis in breastfeeding women. It is theorized that the nipple crack, nipple pain are early warning signs of subacute clinical lactation mastitis. Goal is after application of extra-virgin coconut oil comparative analysis will be done at one week, three weeks, and six weeks. These complications associated with development of subacute mastitis can be addressed early during the first six weeks of lactation. conditions: Lactation Mastitis conditions: Breast Feeding conditions: Staphylococcus Aureus Infection studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Control Trial- Random Assignment-Random Selection primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Extra-Virgin Coconut Oil measure: Measurement of change in pain level (Numeric Pain Rating Scale McCaffery, 1989) measure: Measurement of Development of Nipple Crack (Nipple Tenderness Scale Storr 1988) sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Harris Health System city: Houston state: Texas zip: 77030 country: United States lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06317675 id: ct9873 briefTitle: Osteopathic Manipulative Treatment for Gastro-oesophageal Reflux Disease overallStatus: RECRUITING date: 2024-02-18 date: 2025-12 date: 2026-04 date: 2024-03-19 date: 2024-03-25 name: Studio Osteopatico Busto Arsizio class: OTHER briefSummary: To evaluate the effects of osteopathic manipulative treatment in patients affected by symptoms related to gastro-oesophageal reflux disease (GERD) conditions: Gastro-oesophageal Reflux Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Osteopathic manipulative treatment (OMT) measure: Mean change in GERD-HRQL measure: Adverse effects measure: Exercise adherence measure: Change in drugs use sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CTFO status: RECRUITING city: Saronno state: Varese zip: 21047 country: Italy name: +39 02 96701013 role: CONTACT lat: 45.62513 lon: 9.03517 hasResults: False

 nctId: NCT06317662 id: NCI-2024-01994 id: NCI-2024-01994 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: AALL2321 type: OTHER domain: Children's Oncology Group id: AALL2321 type: OTHER domain: CTEP id: U10CA180886 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180886 briefTitle: Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2027-12-21 date: 2027-12-21 date: 2024-03-19 date: 2024-04-25 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II trial tests the addition of venetoclax and/or blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged \[R\]) or without a KMT2A gene rearrangement (KMT2A-germline \[G\]). Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding venetoclax and/or blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and/or blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL. conditions: Acute Leukemia of Ambiguous Lineage conditions: B Acute Lymphoblastic Leukemia studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 171 type: ESTIMATED name: Asparaginase Erwinia chrysanthemi name: Biospecimen Collection name: Blinatumomab name: Bone Marrow Aspiration name: Calaspargase Pegol name: Computed Tomography name: Cyclophosphamide name: Cytarabine name: Daunorubicin name: Dexamethasone name: Doxorubicin name: Echocardiography name: FDG-Positron Emission Tomography name: Leucovorin name: Lumbar Puncture name: Magnetic Resonance Imaging name: Mercaptopurine name: Methotrexate name: Multigated Acquisition Scan name: Pegaspargase name: Prednisolone name: Prednisone name: Therapeutic Hydrocortisone name: Thioguanine name: Venetoclax name: Vincristine measure: Incidence of dose-limiting toxicities (DLTs) (safety phase) measure: Incidence of DLTs (expansion phase) measure: Minimal residual disease (MRD)-negative remission rate measure: Event free survival (EFS) rates of infants with KMT2A-R acute lymphoblastic leukemia (ALL) measure: 3-year EFS of infants with KMT2A-R ALL measure: Proportion of KMT2A-G patients in Arm C who are able to receive all treatment cycles before maintenance measure: Pharmacokinetics (PK) of venetoclax in infants measure: 3-year EFS of infants with KMT2A-R ALL treated on Arm B measure: 3-year EFS of infants with KMT2A-G ALL treated on Arm C measure: Use of high-throughput sequencing (HTS) for MRD detection in infant ALL compared to centralized flow cytometry measure: PK of calaspargase pegol in infants with ALL measure: Incidence of CD19-negative relapse and myeloid switch relapse with protocol therapy measure: Impact of venetoclax in combination with chemotherapy on T-cell subsets and function measure: Feasibility of T-cell collection and success of T-cell manufacturing for infants with KMT2A-R ALL who receive chimeric antigen receptor T-cell therapy measure: Predictors of response and resistance to venetoclax and overall protocol therapy measure: Impact of subsequent anti-cancer therapy on overall survival sex: ALL maximumAge: 365 Days stdAges: CHILD hasResults: False

 nctId: NCT06317649 id: NCI-2024-01987 id: NCI-2024-01987 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: MM1OA-EA02 type: OTHER domain: ECOG-ACRIN Cancer Research Group id: MM1OA-EA02 type: OTHER domain: CTEP id: U10CA180820 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180820 briefTitle: Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial) overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2025-10-31 date: 2025-10-31 date: 2024-03-19 date: 2024-03-19 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II MyeloMATCH treatment trial compares the usual treatment of azacitidine and venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib in treating older and unfit patients with acute myeloid leukemia and FLT3 mutations. Azacitidine is a drug that is absorbed into DNA and leads to the activation of cancer suppressor genes, which are genes that help control cell growth. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply. This study may help doctors find out if these different approaches are better than the usual approaches. To decide if they are better, the study doctors are looking to see if the study drugs lead to a higher percentage of patients achieving a deeper remission compared to the usual approach. conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 147 type: ESTIMATED name: Azacitidine name: Biospecimen Collection name: Bone Marrow Aspiration name: Bone Marrow Biopsy name: Gilteritinib name: Venetoclax measure: Rate of measured residual disease (MRD) negative complete remission (CR) measure: Overall survival measure: Event-free survival measure: Incidence of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06317636 id: 73487 briefTitle: Propofol-Enhanced Assessment of Ketamine for Chronic Pain and Depression acronym: PEAK overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-01 date: 2025-05 date: 2024-03-19 date: 2024-04-11 name: Stanford University class: OTHER briefSummary: The goal of this clinical trial is to compare ketamine to a placebo when given as a single infusion during sedation in adults with chronic pain and depression. This study aims to:

* Evaluate whether ketamine is more effective than a placebo in treating chronic pain and depression
* Confirm that propofol sedation is a safe way to keep participants blinded to treatment
* Assess patients' comfort with the sedation process to improve future studies
* Explore whether patient expectations affects their pain and depression

Participants will:

* Need to qualify for the study based on stringent medical criteria
* Undergo sedation with propofol
* Randomly receive either a ketamine or a placebo (saline) infusion during sedation
* Complete several study assessments over 5-7 weeks conditions: Chronic Pain conditions: Depression studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: Ketamine name: Normal saline measure: Pain Intensity (past 24 hours) measure: Depression severity measure: Pain Intensity (current) measure: Number and severity of adverse events related to sedation measure: Proportion of participants who accurately recall intra-sedation events measure: Treatment guess measure: Treatment expectancies measure: Pain interference measure: Physical function measure: Number of painful body regions measure: Change in pain medication utilization measure: Pressure pain threshold measure: Enrollment rate measure: Consent fraction measure: Participant Experience Survey sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06317623 id: 0292/21/2023-00590 briefTitle: Urinary Tract Dilations in Prenatal and Postnatal Life overallStatus: RECRUITING date: 2023-01-01 date: 2025-12 date: 2026-06 date: 2024-03-19 date: 2024-03-19 name: SonoClinic class: NETWORK briefSummary: The goals of this study are to use a questionnaire survey to determine the state of awareness of the diagnosis and management of patients with urinary tract dilation across several medical professionals, to predict the severity of the postnatal course and surgical intervention in fetuses with urinary tract dilation detected during pregnancy, and to create a model of prenatal and postnatal care for patients with dilation of the urinary tract for multidisciplinary use. conditions: Urinary Tract Dilatation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Prenatal and postnatal ultrasound examination measure: The goal is the prediction of severe postnatal course and surgical intervention in fetuses with dilatation of the urinary tract according to the UTD classification created in 2014. sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Svetlana Jánošová status: RECRUITING city: Záborské zip: 08253 country: Slovakia name: Svetlana Jánošová role: CONTACT phone: +421908369470 email: svetlana.janosova@gmail.com name: Róbert Dankovčík role: CONTACT phone: +4219051291297 email: dankovcik@gmail.com lat: 48.9451 lon: 21.28977 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-12-19 uploadDate: 2024-02-26T14:43 filename: Prot_000.pdf size: 1211102 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-19 uploadDate: 2024-02-26T14:43 filename: ICF_001.pdf size: 373557 hasResults: False

 nctId: NCT06317610 id: CQGOG0206 briefTitle: Artificial Intelligence Model for Growth Prediction of Ovarian Cancer Organoids overallStatus: RECRUITING date: 2022-01-01 date: 2024-04-30 date: 2024-05-30 date: 2024-03-19 date: 2024-03-19 name: Chongqing University Cancer Hospital class: OTHER briefSummary: The present study aims to collect early bright field image of patient-derived organoids with ovarian cancer. By leveraging artificial intelligence, this study will seek to construct and refine algorithms that able to predict growth of ovarian cancer organoids. conditions: Ovarian Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 100 type: ESTIMATED name: growth prediction of ovarian cancer organoids in the frame of bright field image by leveraging AI measure: AUC of growth prediction performance using deep learning model measure: Accuracy of growth prediction using deep learning model sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Chongqing Cancer Hospital status: RECRUITING city: Chongqing state: Chongqing zip: 400030 country: China name: Dongling Zou, M.D. role: CONTACT phone: 13657690699 email: cqzl_zdl@163.com name: Dongling Zou, M.D. role: PRINCIPAL_INVESTIGATOR lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06317597 id: OSS2024-0311 briefTitle: Efficacy of Short Time Intervals in Split-Dose Bowel Preparation of Oral Sulfate Solution for Colonoscopy overallStatus: ENROLLING_BY_INVITATION date: 2024-03-15 date: 2024-12-01 date: 2024-12-30 date: 2024-03-19 date: 2024-03-19 name: Changhai Hospital class: OTHER name: Peking University People's Hospital name: Internet Hospital of Tianjin Medical University General Hospital name: The Affiliated Suzhou Hospital of Nanjing Medical University name: Tianjin First Central Hospital name: Tianjin Beichen Hospital name: ShangDong Provincial Hospital name: The Affiliated Hospital of Qingdao University name: First People's Hospital of Hangzhou name: The Third People's Hospital of Chengdu name: Ningbo Yinzhou District Second Hospital name: Changshu Affiliated Hospital of Soochow University name: Linyi People's Hospital name: Shanghai East Hospital name: Heilongjiang Province Hospital Nangang Branch name: The Affiliated Jiangyin Hospital of Nantong University name: West China Hospital briefSummary: To evaluate whether oral sulfate solution administered in a short time interval (6-8 hours) between the first and last dose of laxative is not inferior to a long time interval (10-12 hours) in bowel preparation quality. conditions: Colonoscopy: Bowel Preparation studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 448 type: ESTIMATED name: Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution name: Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution measure: Bowel preparation adequate rate measure: Acceptability of bowel preparation by questionnaire survey measure: Incidence of laxative-related adverse events assessed by clinical examinations measure: Colonoscopy completion rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changhai Hospital city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06317584 id: NMRPF3M0042 briefTitle: Empowerment-based Complementary and Alternative Medicine (ECAM) acronym: CAM overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-04 date: 2025-07-31 date: 2024-03-19 date: 2024-03-21 name: Chang Gung University of Science and Technology class: OTHER name: National Science and Technology Council name: Chang Gung Memorial Hospital briefSummary: This phase study will use a randomized trial method to evaluate the performance of the ECAM educational app in the promotion of CAM health literacy and communication among patients with diabetes. conditions: Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized trail method primaryPurpose: HEALTH_SERVICES_RESEARCH masking: QUADRUPLE maskingDescription: The process of keeping the study group assignment hidden after the allocation to participant, care provider, investigator, outcomes assessor whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 86 type: ESTIMATED name: Experimental: Empowerment Application for CAM Health Education name: Written Paper for CAM Health Education measure: Understanding the benefits-risks of complementary therapies (CTs) use scale Alternative Medicine (CAM) use questionnaire measure: Quality of life questionnaire measure: Diabetes Empowerment scale measure: Blood Glucose (GLU) measure: Glycated Hemoglobin(HbA1c) measure: ALanine aminoTransferase，Glutamic Pyruvic Transaminase(ALT/GPT) measure: ASpartate aminoTransferase，Glutamic Oxaloacetic Transaminase (AST/GOT) measure: Blood Urea Nitrogen(BUN) measure: Creatinine(CREA) measure: High Density Lipoprotein(HDL) measure: Total Bilirubin(T.BIL) measure: Serum total cholesterol(TC) measure: Triglyceride (TG) measure: Glomerular filtration rate(GFR) measure: Albumin to Creatinine Ratio (ACR) sex: ALL minimumAge: 20 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHENG GUNG MEMORIAL HOSPITAL, Linkou city: Taoyuan City state: Guishan District zip: 333 country: Taiwan lat: 24.95233 lon: 121.20193 hasResults: False

 nctId: NCT06317571 id: CelalBayarU-SBF-OT-01 briefTitle: Evaluation of The Effect of Fertility Support Education Given to Infertile Couples overallStatus: COMPLETED date: 2021-03-15 date: 2021-12-28 date: 2022-08-10 date: 2024-03-19 date: 2024-03-20 name: Celal Bayar University class: OTHER briefSummary: The aim of the this study was to evaluate the effect of fertility support education given to infertile couples before treatment. conditions: Infertility studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups with intervention group and control group primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 90 type: ACTUAL name: fertility support education measure: Infertility Stress Scale measure: Infertility Self-Efficacy Scale-Short Form measure: Fertility Readiness Scale measure: Fertiqol Quality of Life Scale measure: Blood cortisol level sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi city: Manisa zip: 45060 country: Turkey lat: 38.61202 lon: 27.42647 hasResults: False

 nctId: NCT06317558 id: 22/492-3694 briefTitle: Real-world Clinical Outcomes of NSCLC Patients Receiving Neoadjuvant Immunotherapy acronym: NeoIM-Lung overallStatus: RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2027-12-31 date: 2024-03-19 date: 2024-03-19 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: The goal of this observational study is to evaluate the efficacy and long-term clinical outcomes of different neoadjuvant immunotherapies in NSCLC patients using the real-world data. The main questions it aims to answer are:

* What the best setting for immune checkpoint inhibitors as the neoadjuvant treatment?
* How to determine the subgroups of patients benefit from neoadjuvant immunotherapy? Participants will receive neoadjuvant immunotherapy the study will analyze the real-world data. conditions: NSCLC studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 4000 type: ESTIMATED name: Neoadjuvant immunotherapy name: Other drugs for neoadjuvant treatment measure: Pathological Complete Response (pCR) measure: Disease-free survival(DFS) measure: OS (overall survival) measure: EFS (event-free survival) measure: Major Pathological Response (MPR) measure: Relapse Patterns sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shugeng Gao status: RECRUITING city: Beijing state: Beijing zip: 100020 country: China name: Shugeng Gao, Vice president role: CONTACT phone: 010-87788177 email: gaoshugeng@cicams.ac.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06317545 id: REC/RCR&AH/23/0167/shan ali briefTitle: Effects of Nerchal Exercises on Lateral Epicondylitis. overallStatus: COMPLETED date: 2023-11-01 date: 2024-03-28 date: 2024-03-28 date: 2024-03-19 date: 2024-04-19 name: Riphah International University class: OTHER briefSummary: Painful condition of lateral epicondyle of the humerus characterized by the inflammation of the tendons during loading of the wrist extensor muscles is a common musculoskeletal presentation in men and women between 35 and 54 years of age. The above symptom is associated with a clinical diagnosis of lateral elbow tendinopathy (LET), also known as tennis elbow or lateral epicondylalgia the two effective treatment approaches for lateral epicondylitis are Nirschl exercises and Mulligan taping. This study aims to evaluate the effectiveness of Nirschl exercises with or without Mulligan taping in treating lateral epicondylitis. The study design for this project employs a randomized controlled trial and a sample of individuals with lateral epicondylitis randomly assigned in one of the two groups i.e., Nirschl exercises only and Nirschl exercises with Mulligan taping. Nirschl exercises involve the eccentric strengthening of the wrist extensor muscles and forearm. The participants in both groups will receive Nirschl exercises while the second group will also receive Mulligan taping, which involves the application of tape to the lateral aspect of the elbow to offload stress during movement of the extensor tendons. Different outcome measures including pain intensity, functional disability, grip strength, range of motion will be evaluated using, PRTEE Scale, Visual Analogue Scale (VAS) and Calibrated Jammer hand held dynamometer. Statistical analysis, including independent t-tests or chi-square tests, will be conducted to compare the outcomes between the two groups. The significance level will be set at p \< 0.05. This study will contribute to the evidence base regarding the efficacy of Nirschl exercises and Mulligan taping in managing lateral epicondylitis and will help the clinicians and patients in deciding the best treatment approach for lateral epicondylitis. conditions: Lateral Epicondylitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 56 type: ACTUAL name: Mulligan Taping measure: Pain intensity measure: Grip strength measure: Disability sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: BARKI Advanced Physiotherapy Center city: Multan state: Punjab zip: 60000 country: Pakistan lat: 30.19679 lon: 71.47824 facility: KAIMS Physiotherapy and Rehabilitation Center city: Multan state: Punjab zip: 60000 country: Pakistan lat: 30.19679 lon: 71.47824 hasResults: False

 nctId: NCT06317532 id: P.T.REC/012/004766 briefTitle: Effect of Functional Exercises on Pain and Quality of Life in Females With Primary Dysmenorrhea overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-05-20 date: 2024-05-20 date: 2024-03-19 date: 2024-03-20 name: Cairo University class: OTHER briefSummary: The aim of the study will be to investigate the effect of functional exercises on pain and quality of life in females with primary dysmenorrhea. conditions: Primary Dysmenorrhea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 58 type: ESTIMATED name: Lifestyle modification advice name: Functional exercises measure: Visual analogue scale (VAS) measure: The Menstrual Distress Questionnaire measure: Quality of life enjoyment and satisfaction questionnaire measure: Pressure pain threshold assessment sex: FEMALE minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Cairo University city: Giza country: Egypt name: Manar E. Al-Emary, M.Sc. Stud role: CONTACT phone: +20 128 660 0931 email: manaralemary@gmail.com name: Mai Mohamed Ali, PhD role: CONTACT name: Soheir Mahmoud Elkosery, Prof. role: PRINCIPAL_INVESTIGATOR name: Amr Hazem Abbassy, Assis. Prof. role: PRINCIPAL_INVESTIGATOR lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06317519 id: 09.2020-Oss briefTitle: Verify the Performance in Clinical Practice of the Immersive Virtual Reality Platform GRAIL (Gait Real-time Analysis Interactive Lab) overallStatus: RECRUITING date: 2021-04-12 date: 2026-04-12 date: 2026-04-12 date: 2024-03-19 date: 2024-03-19 name: IRCCS Eugenio Medea class: OTHER briefSummary: Gait pattern difficulties, balance and coordination deficits often characterize patients with congenital and acquired neuromotor disorders and have a significant impact on the quality of life of these subjects. There are various treatments used and in recent years, the advent of advanced technologies in rehabilitation and, in particular, devices based on virtual reality, has opened up new possibilities in rehabilitation. Virtual reality is a promising strategy that incorporates many principles crucial to motor learning, such as high-intensity, repetitive, goal-oriented tasks, enhanced synchronized sensory signals, and active participation. The virtual environment is also suitable for personalized treatment based on the needs of the individual patient.

The GRAIL (Gait Real-time Analysis Interactive Lab) is a device that integrates immersive virtual reality with an instrumented treadmill and a motion capture system, which can be used with both rehabilitation and evaluation goals. To date, there are still few studies of this device in the pediatric field.

The objective of the study is to verify the performance in clinical practice of the immersive virtual reality platform GRAIL and determine any secondary effects by evaluating whether they entail acceptable risks compared to the expected performances following the protocol defined at the IRCCS Medea by Bosisio Parini, in children and adolescents with congenital and acquired neuromotor pathology.

Patients suffering from acquired and congenital brain injuries undergo a combined rehabilitation treatment consisting of 20 sessions with GRAIL and 20 physiotherapy sessions in four weeks. The same subjects undergo evaluations before and at the end of the treatment

The study is prospective and involves the verification of performance through clinical and instrumental evaluations in the population of subjects treated with the GRAIL device at the IRCCS Medea-Bosisio Parini. conditions: Acquired Brain Injury conditions: Cerebral Palsy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Physical Rehabilitation name: Gait Real-time Analysis Interactive Lab measure: 6 minute walking test measure: Gross Motor Function Measure -total score sex: ALL minimumAge: 5 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT facility: Scientific Institute IRCCS Eugenio Medea status: RECRUITING city: Bosisio Parini state: Lecco zip: 23842 country: Italy name: Elena Beretta, MD role: CONTACT phone: 031877851 phoneExt: +39 email: elena.beretta@lanostrafamiglia.it lat: 45.80075 lon: 9.29 hasResults: False

 nctId: NCT06317506 id: RC 43/2022 briefTitle: Methylation Pattern and Pain Sensation in Children With Intellectual Disability overallStatus: COMPLETED date: 2022-05-30 date: 2023-10-10 date: 2023-10-10 date: 2024-03-19 date: 2024-03-19 name: IRCCS Burlo Garofolo class: OTHER briefSummary: Previous literature data indicate that children with intellectual disability (ID) experience more severe pain and more frequently than their cognitively healthy peers, during their daily life. Repeated and chronic pain exposure triggers a vicious circle of hyperalgesia and reduction of the impaired cognitive and adaptive function. Furthermore, these children are unable to rationalize any intervention targeted to contain potentially painful actions.

Epigenetics studies mechanisms responsible for a set of modifications that regulate gene expression without altering the DNA sequence itself. DNA methylation and posttranslational modification of histones are the main epigenetic mechanisms. It is widely accepted that these mechanisms can be engaged by environmental experience, such as early life trauma, pain or addiction leading to the idea of epigenetics as 'a bridge' between genes and environment.

Several epigenetic studies evaluated genes coding proteins involved in recycling of neurotransmitters (SCL6A4), in transmission of painful stimuli (TRPA1) and in response to analgesics (OPRM1). In particular, some studies assessed TRPA1 gene, coding for a cationic channel responsible for the transmission of thermal-painful sensations, and SCL6A4, a serotonin-recycling transmembrane protein presents at inter-synaptic level, have highlighted the importance of methylation in a pathological experience of chronic pain and anxiety disorder in the adult population. Opioid receptor OPRM1 is involved in the endogenous and exogenous opioid-mediated analgesia and a recent work in a group of adolescents treated for idiopathic scoliosis highlights a link between greater pain post-surgery and methylation of this gene. In this context, children with ID are at greater risk of undertreatment both for the difficulty in pain recognition and for the fear of medication-adverse reactions.

The epigenetic study of the aforementioned genes in children with ID associated with an evaluation of painful experiences and clinical history, could help understanding a scenario that it is still complex nowadays before the eyes of parents and caregivers and healthcare workers.The finding of a different methylation pattern in children with ID could in part explain the different pain experience. conditions: Intellectual Disability studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 36 type: ACTUAL measure: Between groups differences in methylation levels sex: ALL minimumAge: 3 Years maximumAge: 17 Years stdAges: CHILD facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" city: Trieste zip: 34137 country: Italy lat: 45.64953 lon: 13.77679 hasResults: False

 nctId: NCT06317493 id: RC 15/2021 briefTitle: Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment overallStatus: RECRUITING date: 2021-01-03 date: 2024-12-31 date: 2024-12-31 date: 2024-03-19 date: 2024-03-22 name: IRCCS Burlo Garofolo class: OTHER briefSummary: The results of the previous study on auditory effort in young children with cochlear implants show that pupils respond to the presence or the absence of the perceived stimuli. The investigators hypothesize that the perceived sounds will elicit increased pupil dilation compared to the non-perceived sounds and that the hearing threshold as measured with pure tone audiometry will correlate to the results in pupillometry test. The investigators hypothesize that the effect will be visible in all testing groups albeit the relative increase of pupil size with age. Hypothesis confirmed, the investigators will develop a standardised procedure for the auditory signal detection using pupillometry. Such a procedure could represent an important bridge between automatic and behavioral hearing tests. With a more precise test of auditory threshold of young children, post-operative monitoring and fitting of cochlear implants or hearing aids, and rehabilitation procedures, could be considerably more targeted and consequentially more efficient. conditions: Hearing Impaired Children studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 180 type: ESTIMATED name: Stimuli measure: Sensitivity index of pupillometry test sex: ALL minimumAge: 4 Months maximumAge: 36 Months stdAges: CHILD facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" status: RECRUITING city: Trieste zip: 34137 country: Italy name: Eva Orzan, MD role: CONTACT phone: +39.040.3785.537 email: eva.orzan@burlo.trieste.it lat: 45.64953 lon: 13.77679 hasResults: False

 nctId: NCT06317480 id: QH_2024 briefTitle: Outcomes Comparison Between Bone Resection and Subperiosteal Dissection for Specific Type of Soft Tissue Sarcoma overallStatus: COMPLETED date: 2000-05-01 date: 2020-05-01 date: 2023-09-01 date: 2024-03-19 date: 2024-03-19 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: the purpose of this study is to assess whether bone resection for thigh soft tissue sarcoma with cortical involvement of the adjacent bone result in better local control and survival compared to sub-periosteal dissection. Investigators also aim to find out the prognostic factors for clinical outcomes in this group of patients. conditions: Soft Tissue Sarcoma conditions: Cortical Contact studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 142 type: ACTUAL name: bone resection name: subperiosteal excision measure: survival measure: recurrence measure: metastasis measure: functional outcomes sex: ALL minimumAge: 8 Years maximumAge: 85 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06317467 id: RC 01/2023 briefTitle: Role of Anti-C1q Autoantibodies in Pregnancy overallStatus: RECRUITING date: 2023-09-13 date: 2026-12 date: 2026-12 date: 2024-03-19 date: 2024-03-19 name: IRCCS Burlo Garofolo class: OTHER briefSummary: Preeclampsia (PE) is a very frequent obstetric complication. C1q, the first recognition molecule of the classical pathway of complement system (C), represents a double-edged molecule in determining pregnancy outcomes. In animal models, C1q deficiency caused the development of a dysfunctional placenta and PE-like symptoms. Conversely, lower levels of C components were detected in the sera of patients with PE due to C consumption and increased deposition of activated C components in the placenta, as well as to the binding to placental apoptotic bodies, syncytiotrophoblast microvesicles (STBM) and debris which are increased in the circulation of patients with PE.

C1q is a hexameric glycoprotein of 460kDa composed by six copies of three polypeptide chains A, B and C, each made by a C-terminal globular head (gC1q) and a N-terminal collagen-like region (CLR). This molecule can be the target of an antibody response. Autoantibodies targeting C1q were first recognized in the serum of Systemic Lupus Erythematosus (SLE) patients. The presence of anti-C1q autoantibodies was also detected in patient affected by autoimmune disease (ie, kidney disorders, vasculitis, thyroiditis). Almost all of these autoimmune disorders are associated with an increased risk of developing PE during pregnancy.

Anti-C1q detection mainly concerns the prediction of the onset of lupus nephritis (LN) in SLE patients. Although anti-C1q autoantibodies do not deplete circulating C1q, their presence in maternal circulation and in placenta may trigger improper C activation and impair C1q activity. In pregnancies complicated by autoimmune affection such as SLE, autoimmune thyroid disorders and Antiphospholipid syndrome (APS) the prevalence of anti-C1q appeared to be higher than in control pregnancies and associated with miscarriage. High levels of anti-C1q have been found in a group of Japanese patients suffering recurrent pregnancy loss (RPL). In a group of anti-C1q positive healthy pregnancies and LN patients was assessed whether C1q autoantigenic behaviour could vary among individuals with or without correlated manifestation. Sera from healthy pregnancies and LN patients were screened for the presence of autoantibodies against the CLR fragment and/or the gC1q: antibodies against gC1q were found in both groups, whereas anti-CLR were only detected in the LN one, suggesting that only the latter may have a pathogenic role. Despite this, the biological functions of anti-C1q remain far from clear conditions: Pre-Eclampsia studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 54 type: ESTIMATED name: Blood sampling name: Blood sampling measure: Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies measure: Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies measure: Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies measure: Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies measure: Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies measure: Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies measure: Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies measure: Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" status: RECRUITING city: Trieste zip: 34137 country: Italy name: Chiara Agostinis, BSc role: CONTACT phone: 040/5588652 email: chiara.agostinis@burlo.trieste.it lat: 45.64953 lon: 13.77679 hasResults: False

 nctId: NCT06317454 id: GR-2019-12369573 briefTitle: Determinants of Metabolic Control in Children With Type 1 Diabetes Mellitus overallStatus: RECRUITING date: 2021-11-11 date: 2024-12-31 date: 2024-12-31 date: 2024-03-19 date: 2024-03-19 name: IRCCS Burlo Garofolo class: OTHER briefSummary: A good metabolic control of type 1 diabetes mellitus (T1DM) is crucial to avoid long-term complications associated with the disease. Although recent evidences suggest that a good metabolic control of T1DM is partly independent of management intensity and could be anticipated since onset, factors that influence glycated haemoglobin (HbA1c) patterns remain poorly understood and are likely to be genetic.

While significant progress has been made in understanding of the genetic contribution to T1DM onset, very few studies have evaluated the role of genetic factors on T1DM metabolic control.

This study aims to create a comprehensive database of genetic and phenotypic data in a cohort of children and young adults with T1DM and to evaluate genetic and environmental factors that might predict trajectories in glycemic control conditions: Diabetes Mellitus, Type 1 studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 800 type: ESTIMATED name: Blood and saliva analysis measure: Identification of environmental factors affecting T1DM metabolic control measure: Identification of genetic factors affecting T1DM metabolic control sex: ALL minimumAge: 6 Years maximumAge: 21 Years stdAges: CHILD stdAges: ADULT facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" status: RECRUITING city: Trieste zip: 34137 country: Italy name: Antonietta Robino role: CONTACT phone: +39.040.3785.470 email: antonietta.robino@burlo.trieste.it name: Silvia Tommasi role: CONTACT phone: +39.040.3785.863 email: silvia.tommasi@burlo.trieste.it lat: 45.64953 lon: 13.77679 hasResults: False

 nctId: NCT06317441 id: NIMCSF137 briefTitle: The Safety and Efficacy of a Probiotic Intervention on SIBO and Related Gastrointestinal Symptoms overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2024-12 date: 2024-03-19 date: 2024-03-19 name: Nimble Science Ltd. class: INDUSTRY name: Lallemand Health Solutions briefSummary: In this study, the goal is to evaluate whether a probiotic formula may reduce symptoms of bloating and abdominal distension in a population suffering from Small Intestinal Bacterial Overgrowth (SIBO) in comparison to a placebo. In addition to the incidence of SIBO, changes to other gastrointestinal symptoms will be assessed. Lastly, the associations between the SIBO status and microbiome from the small and large intestines will be explored using the SIMBA capsule. conditions: Small Intestinal Bacterial Overgrowth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 105 type: ESTIMATED name: Probiotic measure: Change in bloating/distension severity measure: Median bloating-free days measure: Change in median bloating/distension severity measure: Change in abdominal discomfort/pain measure: Changes in gastrointestinal symptoms measure: Changes in stool frequency and consistency measure: Changes in the quality of life measure: Changes in reflux incidence and severity measure: Changes in the severity of IBS symptoms measure: Recovery rate of the probiotic strain measure: Microbiome changes within small intestine, fecal and saliva samples measure: Investigation how the microbiome and SIBO associate with each other though bacterial population analyses. measure: Change in SIBO positivity rate measure: Exploratory metabolomic analysis measure: Exploratory: Quantifying B. subtilis cell proportions measure: Safety outcomes sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Nimble Science city: Calgary state: Alberta zip: T2L 1Y8 country: Canada name: Gwen Duytschaever role: CONTACT phone: 4037032436 email: Gwen@nimblesci.com name: Christopher N Andrews, MD role: PRINCIPAL_INVESTIGATOR lat: 51.05011 lon: -114.08529 facility: Nimble Science city: Calgary state: Alberta zip: T2L 1Y8 country: Canada name: Marsha Burnes role: CONTACT phone: 4037032436 email: Marsha@nimblesci.com name: Christopher N Andrews, MD role: PRINCIPAL_INVESTIGATOR lat: 51.05011 lon: -114.08529 hasResults: False

 nctId: NCT06317428 id: INRCA_001_2024 briefTitle: NT-proBNP Levels During Triple Therapy With Formoterol/Glycopyrrolate/Budesonide in Patients With COPD. acronym: NTproBNP overallStatus: RECRUITING date: 2022-06-28 date: 2025-12-31 date: 2025-12-31 date: 2024-03-19 date: 2024-03-19 name: Istituto Nazionale di Ricovero e Cura per Anziani class: OTHER briefSummary: Observational prospective study to evaluate serum NT-proBNP levels in a population of COPD patients three months after the iniation of triple inhaled formoterol/glycopyrrolate/budesonide therapy. conditions: COPD studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 29 type: ESTIMATED measure: Change in serum NT-pro-BNP levels sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: INRCA Hospital status: RECRUITING city: Ancona country: Italy name: Francesco Spannella role: CONTACT email: f.spannella@inrca.it name: Riccardo Sarzani, MD role: PRINCIPAL_INVESTIGATOR lat: 43.5942 lon: 13.50337 facility: IRCCS INRCA Hospital status: RECRUITING city: Osimo country: Italy name: Erilda Kamberi, MD role: CONTACT email: e.kamberi@inrca.it name: Yuri Rosati role: PRINCIPAL_INVESTIGATOR lat: 43.48539 lon: 13.48222 hasResults: False

 nctId: NCT06317415 id: HuazhongU20240312 briefTitle: Intervention on Non-prescription Antibiotic Use Among the Public overallStatus: COMPLETED date: 2023-04-01 date: 2023-12-31 date: 2024-03-01 date: 2024-03-19 date: 2024-03-20 name: Huazhong University of Science and Technology class: OTHER name: Fuyong People's Hospital, Bao 'an District, Shenzhen City, Guangdong briefSummary: The purpose of this study is to test the effectiveness of health education int led by community health workers for non-prescription antibiotic use among the public. In this two arm cluster randomised trial, In this two-arm cluster randomized controlled trial, 22 communities were randomly allocated in a 1:1 ratio to intervention and control groups. In the intervention group, family doctors will conduct WeChat-based health education on responsible use of antibiotic for the participants. In the control group, only routine public health education will be provided without any involvement in antibiotic use. The primary outcome is the incidence of antibiotic use without prescription in the past month. conditions: Non-Prescription Drug Misuse conditions: Antibiotic Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 1550 type: ACTUAL name: WeChat-based health education on antibiotic use name: Regular public health education measure: Rate of non-prescription antibiotic use among the public sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fuyong People's Hospital city: Shenzhen state: Guangdong zip: 518103 country: China lat: 22.54554 lon: 114.0683 hasResults: False

 nctId: NCT06317402 id: APHP240133 briefTitle: Epidemiology and Management of Malnutrition of Patients Hospitalized at the Pitié-Salpêtrière Hospital: a One-day Survey Combined With Focus Groups (Mixed Methods) acronym: EPIDENUT_PSL overallStatus: RECRUITING date: 2024-03-09 date: 2025-09-09 date: 2025-09-09 date: 2024-03-19 date: 2024-04-09 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: According to the literature, malnutrition affects between 30% and 50% of hospitalized patients. The most recent survey on the prevalence of malnutrition in hospitals in France dates back to 2003, and at the Pitié Salpêtrière Hospital to 2015. Malnutrition is a pathological process that can lead to complications for patients and prolong their length of stay.

Main objective: Evaluate the prevalence of malnutrition in adult patients hospitalized on a given day at Pitié-Salpêtrière Hospital (PSL) according to HAS ( High Authority for Health) criteria for 2019 (if age \<70 years) and 2021 (if age ≥ 70 years). conditions: Malnutrition studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 385 type: ESTIMATED name: malnutrition questionary measure: Prevalence of undernutrition diagnosed according to HAS 2019 and 2021 criteria on a given day in hospitalized PSL patients. measure: Compare the prevalence and the severity of undernutrition in hospitalized PSL patients according to the HAS criteria of 2019 (if age <70 years) and 2021 (if age ≥ 70 years) versus those of 2003 (if age <70 years) and 2007 (if age ≥ 70 years). measure: Evaluate the quality of nutritional management for malnourished patients hospitalized at PSL. Using PMSI coding, assess the value of activities associated with undernutrition in undernourished patients hospitalized at PSL. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Service de nutrition, Hôpital Pitié-Salpêtrière status: RECRUITING city: Paris zip: 75013 country: France name: Pauline Faucher, Dr role: CONTACT phone: 01 42 17 57 71 phoneExt: 33 email: pauline.faucher@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06317389 id: 69HCL23_1237 briefTitle: PACOME (PAtient Cancer Oral MEdication) Cohort of Patients Treated With Oral Anticancer Drugs Benefiting From Oncoral Multidisciplinary Monitoring in Real Life: Predictive Factors and Safety of Treatments acronym: PACOME overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2034-11 date: 2037-01 date: 2024-03-19 date: 2024-03-19 name: Hospices Civils de Lyon class: OTHER briefSummary: With the shift to ambulatory care and the rise of ATCO oral anticancer drugs, a growing number of cancer patients are benefiting from oral treatment in an outpatient setting, which meets their needs and preference over injectable chemotherapy with more autonomy and less time spent in the hospital. However, outside the safe hospital context, the complex pharmacological profile of ATCO exposes patients to iatrogenic drug risks. These medicinal problems or Drug Related Problems DRP linked to ATCO are sources of dosage modifications and lead to sub-therapeutic doses compared to clinical trials and consequently to a reduction, in life actual, dose-intensity and expected response. Furthermore, insufficiently controlled in an ambulatory environment and due to a lack of city-hospital coordination, DRPs lead to an increase in the consumption of care.

Oncoral is the pioneering multidisciplinary city-hospital monitoring of outpatients treated with oral anticancer drugs. Set up in 2014 by the Hospices Civils de Lyon, this educational monitoring is based on a tripartite hospital intervention (oncologist, pharmacist, nurse) and a structured city-hospital link with private health professionals (attending doctor, community pharmacist and freelance nurse). Multidisciplinary interventions are focused on PROs and DRPs and combine an educational approach for the patient based on their needs and potential social vulnerabilities.

The PACOME real-life database will describe the population of ambulatory patients treated by ATCO benefiting from the secure multidisciplinary city-hospital Oncoral pathway with the aim of improving knowledge on this population, on the real-life use of ATCO and on new methods of organizing ambulatory cancer care.

The PACOME database collects sociodemographic, clinical and therapeutic data, and experiences in this population. Patients quality of life and other PROs (symptoms and adverse effects experienced by patients), social determinants, health care consumption, the caregiver-patient relationship, the use of digital technology in health, the organization of care, the city-hospital link (interventions of actors and their temporality).

This base will make it possible to optimize the treatment of patients at the individual and population level and to generate evidence in addition to clinical trials, which are expected by health professionals and decision-makers. With patient data from the secure Oncoral pathway, PACOME brings together the three major and inseparable assets of real-life databases: quality, completeness and meaning of the data. It constitutes a basis for essential academic and private collaborations for studies on data and comparative observational or interventional studies, which will contribute to the animation of the new ecosystem of real-life health data in oncology. conditions: Cancer conditions: Oncology conditions: Oncoral Program studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 3000 type: ESTIMATED name: Questionnaires measure: Relative-Dose-Intensity (RDI) in real life with a prospective follow-up of 6 months within the limit of the duration of treatment with oral anticancer drugs by setting up a data platform for adult patients taking oral anticancer drugs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Groupement Hospitalier Sud - Unité de Pharmacie Clinique Oncologique city: Pierre-Bénite zip: 69495 country: France name: Catherine RIOUFOL, Pr role: CONTACT name: Florence RANCHON, MCU-PH role: SUB_INVESTIGATOR name: Anne-Gaëlle CAFFIN, Dr role: SUB_INVESTIGATOR name: Marie-Anne CERFON, PH role: SUB_INVESTIGATOR lat: 45.7009 lon: 4.82511 hasResults: False

 nctId: NCT06317376 id: REC/014131 Maria Haseen briefTitle: Group-based Cardiac Rehabilitation on Patients With Coronary Artery Bypass Graft Surgery overallStatus: COMPLETED date: 2023-09-01 date: 2024-01-15 date: 2024-01-18 date: 2024-03-19 date: 2024-03-19 name: Riphah International University class: OTHER briefSummary: 1. To determine the effect of Moderate intensity continuous training on Pulmonary function of CABG patients.
2. To determine the effect of MICT on aerobic Capacity of CABG patients. conditions: Post-cardiac Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 54 type: ACTUAL name: MICT with Aerobic exercise on treadmill name: standard hospital protocol measure: Borg rating of perceived exertion scale measure: 6min walk test sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: RMI city: Peshawar country: Pakistan lat: 34.008 lon: 71.57849 hasResults: False

 nctId: NCT06317363 id: REC/RCR&AHS/23/0353 briefTitle: Effects of Acapella VS CHEST Physiotherapy in Post-Operative CABG Patients overallStatus: COMPLETED date: 2023-05-23 date: 2024-01-30 date: 2024-02-15 date: 2024-03-19 date: 2024-03-19 name: Riphah International University class: OTHER briefSummary: Coronary artery bypass grafting (CABG) is a surgical procedure that is performed to improve blood flow to the heart by bypassing blocked or narrowed arteries. CABG is a major surgery that is associated with significant postoperative complications, including pulmonary complications such as atelectasis and pneumonia. Chest physiotherapy is commonly use to prevent and treat these complications, but its effectiveness in post-operative CABG patients is not well established.

The purpose of this study is to evaluate the effects of Acapella device vs chest physiotherapy on pulmonary function, airway clearance and dyspnea in post-operative CABG patients. The group A will receive (baseline treatment aerosol therapy, ACBT, Mobilization, breathing with arm elevation with addition to using Acapella), while the group B will receive base line treatment. aerosol therapy, ACBT, Mobilization, breathing with arm elevation with addition chest physiotherapy percussing for 20 minute The primary outcome measures of the study will be pulmonary function tests, including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and FEV1/FVC, and Modified Borg dyspnea scale . The secondary outcome measures will be the amount of sputum cleared. The study will be conducted over a period of 6 months after approval of synopsis.

The study will be conducted in a tertiary care hospital in Lahore, Pakistan. Patients who have undergone CABG surgery will be screen for eligibility and those who meet the inclusion criteria will be enroll in the study. Patients who have a history of chronic lung disease, smoking, intubated patient or other respiratory conditions will be exclude from the study conditions: CABG studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ACTUAL name: Base Line + ACEPELLA name: Base Line + Manual Chest Physiotherapy measure: Modified Borg Dyspnea Scale measure: FEV1 measure: FVC measure: FEV1/FVC measure: sputum volume measure: body temperature(degree centigrade) measure: pulse rate (beats/minute) measure: respiratory rate( breaths/minute) measure: blood pressure (mmHg) measure: SpO2 (%) measure: SaO2 (%) measure: PaO2 (%) measure: PaCO2 (%) sex: ALL minimumAge: 55 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jinnah Hospital city: Lahore state: Punjab zip: 54600 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06317350 id: GNS-212-E id: 101772 type: OTHER domain: MFDS briefTitle: Clinical Study to Evaluate the Efficacy and Safety of GNS-212-E in Bowel Preparation for Colonoscopy acronym: GNS-212-E overallStatus: RECRUITING date: 2024-03-11 date: 2025-03-31 date: 2025-03-31 date: 2024-03-19 date: 2024-03-20 name: Gunkang Pharmaceuticals, Inc class: INDUSTRY briefSummary: This is a prospective, randomized, single-blind, parallel, active-controlled, and multi-center Phase III clinical trial. conditions: Colonoscopy conditions: Bowel Preparation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 318 type: ESTIMATED name: GNS-212-E1 name: GNS-212-E2 name: GNS-212-ER measure: To evaluate the successful % of bowel preparation before colonoscopy (colon cleanliness) using the HCS (Harefield Cleansing Scale) measure: Overall rate of bowel preparation measure: Overall patient satisfaction and compliance sex: ALL minimumAge: 19 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Byeong Gwan Kim role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06317337 id: Sana Bshir briefTitle: Focused Ultrasound Cavitation Augmented With Aerobic Exercise overallStatus: COMPLETED date: 2022-04-15 date: 2023-04-15 date: 2023-07-15 date: 2024-03-19 date: 2024-03-19 name: Riphah International University class: OTHER briefSummary: This study will determine the combine effects of focused ultrasound cavitation augmented with aerobic exercises. This research could be helpful for the patients who prefer such treatments to make a wise decision that either aerobic exercises in combination with cavitation is the better and much safer treatment option to maintain healthy life. conditions: Central Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 54 type: ACTUAL name: focused ultrasound cavitation augmented with aerobic exercises measure: Borg rating of perceived exertion scale measure: girth measure: 6min walk test sex: FEMALE minimumAge: 25 Years maximumAge: 40 Years stdAges: ADULT facility: Bioflex Aesthetic Clinic city: Peshawar state: KPK country: Pakistan lat: 34.008 lon: 71.57849 hasResults: False

 nctId: NCT06317324 id: bc2023200 briefTitle: Compare the Prognostic Differences Between SBRT and Surgery for NSCLC Patients With Interlobular Fissure Invasion. overallStatus: RECRUITING date: 2023-08-01 date: 2024-08-01 date: 2026-08-01 date: 2024-03-19 date: 2024-03-19 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: The goal of this observational study is to compare the prognostic differences between SBRT and Surgery for NSCLC patients with interlobular fissure invasion. The main questions it aims to answer are:

1. Explore the survival differences.
2. Explore of the lung function changes before and after different treatments. conditions: NSCLC conditions: Radiotherapy conditions: Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Different treatments measure: OS measure: PFS measure: MRFS measure: LRFS measure: VC measure: FVC measure: FEV1 measure: DLCO measure: PFR sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy status: RECRUITING city: Tianjin state: Tianjin zip: 300060 country: China name: Zhao Yan role: CONTACT phone: +86-22-23340123 phoneExt: 5509 email: yanzhaotj@126.com name: Xishan Hao, M.D. role: PRINCIPAL_INVESTIGATOR lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06317311 id: 221968 briefTitle: A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer acronym: RUBY-J overallStatus: NOT_YET_RECRUITING date: 2024-04-16 date: 2026-07-15 date: 2027-08-31 date: 2024-03-19 date: 2024-03-19 name: GlaxoSmithKline class: INDUSTRY briefSummary: The goal of this clinical trial is to understand the effectiveness of dostarlimab and carboplatin-paclitaxel followed by dostarlimab monotherapy in participants with endometrial cancer conditions: Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Dostarlimab name: Carboplatin name: Paclitaxel measure: Durable response rate for 12 months (DRR12) assessed by Blinded independent central review (BICR) measure: DRR12 per RECIST 1.1, assessed by investigator measure: Progression-free survival (PFS) per RECIST 1.1, assessed by BICR and investigator measure: Overall survival (OS) measure: Overall response rate (ORR) per RECIST 1.1 assessed by BICR measure: ORR per RECIST 1.1 assessed by investigator measure: Disease control rate (DCR) per RECIST 1.1 assessed by BICR measure: DCR per RECIST 1.1 assessed by investigator measure: Duration of response (DOR) per RECIST 1.1 assessed by BICR measure: DOR per RECIST 1.1 assessed by investigator measure: Maximum concentration (Cmax) for dostarlimab measure: Minimum concentration (Cmin) for dostarlimab measure: Number of participants with adverse events (AEs), Immune-related adverse events (irAEs), and serious adverse events (SAEs) by severity measure: Number of participants AEs, irAEs, and SAEs leading to dose modifications such as dose delay or study intervention discontinuation measure: Number of participants with AEs leading to death sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GSK Investigational Site city: Aichi zip: 464-8681 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Shiro Suzuki role: PRINCIPAL_INVESTIGATOR lat: 32.51879 lon: 130.62158 facility: GSK Investigational Site city: Chiba zip: 260-8717 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Naotake Tanaka role: PRINCIPAL_INVESTIGATOR lat: 35.6 lon: 140.11667 facility: GSK Investigational Site city: Ehime zip: 791-0280 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Kazuhiro Takehara role: PRINCIPAL_INVESTIGATOR lat: 33.63163 lon: 132.76886 facility: GSK Investigational Site city: Fukuoka zip: 811-1395 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Kazuya Ariyoshi role: PRINCIPAL_INVESTIGATOR lat: 33.6 lon: 130.41667 facility: GSK Investigational Site city: Fukuoka zip: 830-0011 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Shin Nishio role: PRINCIPAL_INVESTIGATOR lat: 33.6 lon: 130.41667 facility: GSK Investigational Site city: Gunma zip: 373-8550 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Kazuto Nakamura role: PRINCIPAL_INVESTIGATOR lat: 36.52592 lon: 138.97142 facility: GSK Investigational Site city: Hokkaido zip: 060-8648 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Hidemichi Watari role: PRINCIPAL_INVESTIGATOR lat: 43.41104 lon: 142.88878 facility: GSK Investigational Site city: Hyogo zip: 673-8558 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Satoshi Yamaguchi role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site city: Ibaraki zip: 305-8576 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Toyomi Sato role: PRINCIPAL_INVESTIGATOR lat: 34.81641 lon: 135.56828 facility: GSK Investigational Site city: Iwate zip: 028-3695 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Tsukasa Baba role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site city: Kanagawa zip: 259-1193 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Takeshi Hirasawa role: PRINCIPAL_INVESTIGATOR lat: 37.58333 lon: 139.91667 facility: GSK Investigational Site city: Okayama zip: 700-8558 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Shoji Nagao role: PRINCIPAL_INVESTIGATOR lat: 34.65 lon: 133.93333 facility: GSK Investigational Site city: Osaka zip: 541-8567 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Shoji Kamiura role: PRINCIPAL_INVESTIGATOR lat: 34.69374 lon: 135.50218 facility: GSK Investigational Site city: Osaka zip: 569-8686 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Satoe Fujiwara role: PRINCIPAL_INVESTIGATOR lat: 34.69374 lon: 135.50218 facility: GSK Investigational Site city: Saitama zip: 350-1298 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Kosei Hasegawa role: PRINCIPAL_INVESTIGATOR lat: 35.90807 lon: 139.65657 facility: GSK Investigational Site city: Shizuoka zip: 411-8777 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Yasuyuki Hirashima role: PRINCIPAL_INVESTIGATOR lat: 34.98333 lon: 138.38333 facility: GSK Investigational Site city: Tochigi zip: 329-0498 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Yuji Takei role: PRINCIPAL_INVESTIGATOR lat: 36.38333 lon: 139.73333 facility: GSK Investigational Site city: Tokyo zip: 104-0045 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Kazuki Sudo role: PRINCIPAL_INVESTIGATOR lat: 35.6895 lon: 139.69171 facility: GSK Investigational Site city: Tokyo zip: 135-8550 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Mayu Yunokawa role: PRINCIPAL_INVESTIGATOR lat: 35.6895 lon: 139.69171 facility: GSK Investigational Site city: Tokyo zip: 160-8582 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Wataru Yamagami role: PRINCIPAL_INVESTIGATOR lat: 35.6895 lon: 139.69171 hasResults: False

 nctId: NCT06317298 id: 2023-013-CH01 IIT-RCC briefTitle: Fruquintinib Plus Everolimus as 2nd Line Therapy of ccRCC Patients Progressed Post IO and TKI Therapy overallStatus: RECRUITING date: 2024-02-21 date: 2025-08-01 date: 2025-12-01 date: 2024-03-19 date: 2024-03-19 name: Peking University First Hospital class: OTHER briefSummary: This study will assess the efficacy and safety profile of fruquintinib in combination with everolimus as second line therapy of clear cell renal cell carcinoma patients who progressed after immunotherapy and tyrosine kinase inhibitor. conditions: Renal Cell Carcinoma, Clear Cell, Somatic studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Fruquintinib and Everolimus measure: MTD (Maximum Tolerated Dose) measure: ORR (Objective Response Rate) measure: PFS (Progression Free Survival) measure: DCR (Decease Control Rate ) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University First Hospital status: RECRUITING city: Beijing country: China name: Zhisong He, MD role: CONTACT phone: +8610-83572418 email: wyj7074@sohu.com name: Kaiwei Yang, MD role: CONTACT phone: 13811501435 email: 13811501435@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06317285 id: 220929 id: 2023-509371-16-00 type: OTHER domain: EU CTR briefTitle: A Study to Evaluate the Efficacy and Safety of GSK3915393 in Participants With Idiopathic Pulmonary Fibrosis (IPF) overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-19 date: 2026-03-19 date: 2024-03-19 date: 2024-03-19 name: GlaxoSmithKline class: INDUSTRY briefSummary: Idiopathic Pulmonary Fibrosis is a chronic lung disease which causes scarring of the lungs and difficulty in breathing. GSK3915393 is a new medicine, which is being tested in participants with IPF for the first time. The study will assess the safety and effectiveness of GSK3915393 in IPF participants. conditions: Idiopathic Pulmonary Fibrosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: This will be a double-blind study with respect to allocation of GSK3915393 or placebo to participants. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: GSK3915393 name: Placebo measure: Absolute Change from Baseline in Forced Vital Capacity (FVC) in milliliters (mL) at Week 26 measure: Absolute Change from Baseline in Forced Vital Capacity (mL) at Weeks 4, 8, 12 and 18 measure: Absolute Change from Baseline in Percent Predicted Forced Vital Capacity (%) at Weeks 4, 8, 12, 18 and 26 measure: Participants Achieving Relative Decline from Baseline in FVC (mL) Less than or Equal to (≤) 5 Percent (%) at Week 26 measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Number of Participants with Clinically Important Findings in Vital Signs measure: Number of Participants with Clinically Important Findings in Electrocardiogram (ECG) measure: Number of Participants with Clinically Important Findings in Haematology measure: Number of Participants with Clinically Important Findings in Hepatobiliary Parameters measure: Number of Participants with Clinically Important Findings in Clinical Chemistry measure: Maximum observed concentration (Cmax) of GSK3915393 in IPF Participants measure: Area under the time-concentration curve (AUC) from Zero (pre-dose) to 4 hours (h) post-dose sample [0-4 h]) of GSK3915393 measure: Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC- inf) of GSK3915393 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06317272 id: RT2016-04-BROTHER Part 1 briefTitle: BReath Hold TecHniquEs for Radiotherapy of Esophageal Carcinoma acronym: BROTHER overallStatus: TERMINATED date: 2021-02-10 date: 2023-09-19 date: 2023-09-19 date: 2024-03-19 date: 2024-03-19 name: University Medical Center Groningen class: OTHER briefSummary: The main objective of the first part of the study is to determine the most optimal method for DIBH (active breathing control vs voluntary coached) and its reproducibility. Based on these findings, one of these methods will be selected for part 2 of this study. conditions: Esophageal Cancer studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The participating patients will undergo weekly (during radiotherapy treatment) 2 CTs in DIBH; one using ABC and one using voluntary coaching (VC). primaryPurpose: TREATMENT masking: NONE count: 1 type: ACTUAL name: DIBH using ABC technique name: DIBH using VC technique measure: Feasibility DIBH measure: Reproducibility DIBH sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UMC Groningen city: Groningen country: Netherlands lat: 53.21917 lon: 6.56667 hasResults: False

 nctId: NCT06317259 id: 809163 briefTitle: Effects of Hypoxic Breathwork overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-11 date: 2024-12 date: 2024-03-19 date: 2024-03-20 name: University of California, San Diego class: OTHER briefSummary: This project will study changes that occur during a short period of intensive daily slow-paced breathing and breath hold practice (i.e., "breathwork"). On the first and last days of the week-long practice, investigators will conduct high-density EEG recordings during breathwork to evaluate spectral power, coherence, and causality dynamics of the brain when it is naïve to breathwork and after adaptation to a breathwork practice. Breath, blood, urine, saliva, stool samples, biometric data, and sleep EEG will be collected before the start of daily breathwork practice and again after 1 week of breathwork practice to examine the effect of breathwork on full body biochemistry, molecular biology, and sleep. Investigators will also use questionnaires to assess the impact of breathwork on stress and sleep quality. conditions: Hypoxic Breathwork With Music and Affirmative Messaging conditions: Hypoxic Breathwork Only conditions: Music and Affirmative Messaging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: We have 3 groups running in parallel (one of each group running in the same week). Group 1 will do breathwork that includes music and positive messaging, group 2 will do breathwork alone with only guided breathing instructions, and group 3 will listen to the music and positive messaging but no breathwork which we call the "meditation" group. primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Subjects will be unaware of the other conditions and will thus not know if they are in a 'control' group or not. All experimenters will know subject group assignments. Subjects will be told of all groups at the end. whoMasked: PARTICIPANT count: 75 type: ESTIMATED name: Hypoxic breathwork plus music and messaging name: Hypoxic breathwork only name: Music and messaging meditation measure: EEG power and/or connectivity differences between groups measure: Group differences in sleep EEG power and/or stage changes from baseline to the intervention period measure: Group differences between physiological changes in proteomics, microbiome, and other factors from baseline following intervention measure: Group differences in mood and stress from before to after the intervention sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06317246 id: ECDSUB briefTitle: Subtypes and Prognostic Factors in Erdheim-Chester Disease overallStatus: RECRUITING date: 2020-09-15 date: 2024-09-15 date: 2024-12-15 date: 2024-03-19 date: 2024-03-19 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Erdheim-Chester Disease (ECD) is a rare form of histiocytosis characterized by the proliferation of blood cells, known as histiocytes, which infiltrate various organs and tissues, often causing irreversible damage. The causes of the pathology are still unknown. Although the disease typically affects adult individuals, cases of pediatric-onset ECD have been described. However, there is a lack of detailed information on the phenotypic characteristics of these patients, and reliable data on response to specific therapies and long-term outcomes are missing. Three patients referred to our reference center for Histiocytosis present a concomitant BRAF-mutated neoplasm. Such an association could be due to the presence of mosaicisms for the BRAF V600E mutation. Mosaicism is a biological event defined as the presence of more than one genetically dissimilar cell population in the same organism and is an increasingly studied field, both in normal and pathological conditions. If proven in ECD as well, this mechanism could contribute to providing answers to the still open questions regarding the development of this disease. conditions: Erdheim-Chester Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 70 type: ESTIMATED name: Investigation of BRAF mosaicism measure: Clinical characteristics of patients with Erdheim-Chester Disease measure: Prognostic factors of patients with Erdheim-Chester Disease sex: ALL minimumAge: 1 Year maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence state: Firenze country: Italy name: Augusto Vaglio role: CONTACT email: augusto.vaglio@meyer.it lat: 43.77925 lon: 11.24626 facility: AOU Parma status: RECRUITING city: Parma country: Italy name: Domenico Corradi role: CONTACT email: domenico.corradi@unipr.it lat: 44.79935 lon: 10.32618 hasResults: False

 nctId: NCT06317233 id: STUDY00007131 briefTitle: Outcomes of a Multidisciplinary Program for the Treatment of Chronic Pelvic Pain overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-10 date: 2024-03-19 date: 2024-03-19 name: Medstar Health Research Institute class: OTHER briefSummary: The goal of this clinical trial is to test the impact of a detailed treatment handbook and follow-up schedule on women seeking care for chronic pelvic pain in a gynecology office-based practice. The main questions it aims to answer are:

* How does the handbook and follow-up impact patient satisfaction?
* How does the handbook and follow-up impact patient pain and quality of life scores? Participants will be randomized to receive the office standard of care, or standard of care plus a printed handbook customized to highlight their diagnosis, treatment plan and follow-up schedule. conditions: Chronic Pelvic Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Chronic Pelvic Pain Treatment Guide measure: Patient Satisfaction measure: Pain Catastrophizing measure: Pelvic Pain sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-01-29 uploadDate: 2024-03-03T20:29 filename: Prot_000.pdf size: 138543 hasResults: False

 nctId: NCT06317220 id: 2024P000152 briefTitle: Vedolizumab for the Treatment of Collagenous Gastritis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-06-01 date: 2028-04-01 date: 2024-03-19 date: 2024-03-19 name: Massachusetts General Hospital class: OTHER name: Takeda name: Dana-Farber Cancer Institute briefSummary: The goal of this clinical trial is to learn about how vedolizumab may affect patients with collagenous gastritis (CG). The main questions it aims to answer are:

* Whether vedolizumab can reduce CG symptoms
* Whether vedolizumab is safe to take for patients with CG

Participants in this study will:

* Receive vedolizumab through an IV ("infusion")
* Complete a survey at each infusion visit
* Have blood collected at each infusion visit
* Undergo an endoscopy with biopsy conditions: Collagenous Gastritis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Vedolizumab measure: Change in symtpoms measure: Response durability measure: Histologic response measure: Incidence of treatment-emergent adverse events (safety) measure: Immunologic response in gastric mucosa measure: Immunologic response in peripheral blood sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States name: Keri Sullivan role: CONTACT phone: 617-724-0195 email: ksullivan79@mgh.harvard.edu name: Jamie DiCarlo role: CONTACT phone: 617-724-9347 email: jdicarlo3@mgh.harvard.edu name: Michael L Dougan, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Lestat Ali, MD role: SUB_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06317207 id: PJ2024-01-44 id: 2019b07030004 type: OTHER_GRANT domain: Anhui Provincial Central Government Guides Local Science and Technology Development Project-Anhui Clinical Research Ce briefTitle: Evaluation of the Safety of Reoperation for Ipsilateral Recurrent Tumors After Nephron-sparing Partial Nephrectomy acronym: LiangAH overallStatus: COMPLETED date: 2013-01-01 date: 2023-12-31 date: 2023-12-31 date: 2024-03-19 date: 2024-03-19 name: The First Affiliated Hospital of Anhui Medical University class: OTHER briefSummary: To evaluate the safety of reoperation in patients with renal tumors who have ipsilateral tumor recurrence after nephron-sparing partial nephrectomy. conditions: Renal Cell Carcinoma conditions: Robotic Surgical Procedures studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 15 type: ACTUAL measure: Operation time measure: Estimated blood loss sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06317194 id: Magnetic Tides briefTitle: A Novel Method of Non-Invasive Brain Stimulation (kTMP) to Enhance Motor Function in Chronic Stroke Patients overallStatus: ENROLLING_BY_INVITATION date: 2024-03-15 date: 2027-06-30 date: 2027-08-30 date: 2024-03-19 date: 2024-03-19 name: Magnetic Tides class: INDUSTRY name: University of California, Berkeley briefSummary: Stroke is a leading cause of disability with many patients suffering chronic motor function impairments that affect their day-to-day activities. The goal of this proposal is to provide a first assessment of the efficacy of an innovative non-invasive brain stimulation system, kTMP, in the treatment of motor impairment following stroke. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 15 type: ESTIMATED name: kTMP name: Sham kTMP measure: Fugl- Meyer Assessment (Upper Extremity) measure: Action Research Arm Test (ARAT) measure: Modified Ashworth Scale (MAS) measure: Trial to Trial Variability (T2TV) measure: Range of Joint Motion (ROM) measure: Grasp to Lift Time measure: Transport Time sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Magnetic Tides city: El Cerrito state: California zip: 94530 country: United States lat: 37.91576 lon: -122.31164 hasResults: False

 nctId: NCT06317181 id: DifLivSPECTRUS briefTitle: Assessment of Liver Diseases Using a Deep-Learning Approach Based on Ultrasound RF-Data acronym: LivSPECTRUS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-06 date: 2025-12 date: 2024-03-19 date: 2024-03-19 name: Technische Universität Dresden class: OTHER name: University Hospital Dresden name: University of Leipzig briefSummary: The goal of this clinical trial is to test the performance of neuronal networks trained on ultrasonic raw Data (=radiofrequency data) for the assessment of liver diseases in patients undergoing a clinical ultrasound examination. The general feasibility is currently evaluated in a retrospective cohort.

The main questions the study aims to answer are:

* Can a neuronal network trained on RF Data perform equally good as elastography in the assessment of diffuse liver diseases?
* Can a neuronal network trained on RF Data perform better than a neuronal network trained on b-mode images in the assessment of diffuse liver diseases?
* Can a neuronal network trained on RF Data distinguish focal pathologies in the liver from healthy tissue?

To answer these questions participants with a clinically indicated fibroscan will undergo:

* a clinical elastography in Case ob suspected diffuse liver disease
* a reliable ground truth (if normal ultrasound is not sufficient e.g. contrast enhanced ultrasound, biopsy, MRI or CT) in case of focal liver diseases, depending on the standard routine of the participating center
* a clinical ultrasound examination during which b-mode images and the corresponding RF-Data sets are captured conditions: Artificial Intelligence conditions: Ultrasonography conditions: Elasticity Imaging Techniques conditions: Liver Diseases conditions: Metastasis to Liver studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Data is collected in a defined group of patients (all patients listed for elastography or for ultrasonic investigation due to a focal lesion in participating departments). Afterwards performances of algorithms are compared based on this group. primaryPurpose: DIAGNOSTIC masking: NONE count: 200 type: ESTIMATED name: Collection of elastography data name: Collection of ultrasonic raw data measure: Performance analysis of the trained model sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-01 uploadDate: 2024-03-15T03:02 filename: Prot_000.pdf size: 271228 hasResults: False

 nctId: NCT06317168 id: SIMPLE-AOBP briefTitle: SIMPLifying Elements of Standardized Automated Office Blood Pressure Measurements (Pilot Study) acronym: SIMPLE-AOBP overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-31 date: 2024-08-31 date: 2024-03-19 date: 2024-03-19 name: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal class: OTHER briefSummary: This study aims to assess whether removing single elements of the standardized office BP measurement procedure will affect the accuracy towards the mean awake ambulatory BP. Four arms are planned in a randomized order: 1) full standardized procedure, 2) standardized procedure but with cuff placed on a sleeve, 3) standardized procedure but arm resting vertically, 4) standardized procedure but with non-validated device.

This is a pilot study to inform on the sample size required to perform adequately powered large scale studies. conditions: Blood Pressure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Mean awake ambulatory BP measurements measure: Difference with mean awake ambulatory systolic BP measure: Difference with mean awake ambulatory diastolic BP sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06317155 id: BournemouthU-AS briefTitle: Occupational Therapy for Children and Young People Who Self-harm: A Qualitative Study overallStatus: NOT_YET_RECRUITING date: 2024-12 date: 2025-09 date: 2025-12 date: 2024-03-19 date: 2024-03-19 name: Bournemouth University class: OTHER name: Dorset HealthCare University NHS Foundation Trust briefSummary: The goal of this qualitative observational study is to explore the experiences of children and their carers, receiving occupational therapy for self-harm and the experiences of health professionals delivering these interventions. The child cohort within the study will have a history of self-harm and have been under the care of Children and Adolescent Mental Health Services.

The main questions it aims to answer are:

* What are the experiences of children and their carers who have received occupational therapy interventions as either a standalone, or adjunct, treatment for self-harm, whilst under the care of Tier 4 CAMHS service.
* What are the experiences of healthcare professionals delivering occupational therapy interventions working within a T4 CAMHS service.
* To understand the participants views on whether occupational therapy interventions are a viable and effective approach to address self-harm amongst young people.

Participants will be asked to complete a questionnaire and take part in a single semi-structured interview. 25% of participants may be asked to take part in a further in depth semi-structured interview. conditions: Self Harm studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Occupational therapy measure: What was the participants experience of receiving or delivering an occupational therapy informed intervention? measure: What was the participants experience of receiving or delivering an occupational therapy informed intervention? measure: Did the participants feel the occupational therapy informed interventions were effective in supporting young people who self-harm or effective in reducing self-harm? measure: Did the participants feel the occupational therapy informed interventions were effective in supporting young people who self-harm or effective in reducing self-harm? sex: ALL minimumAge: 13 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06317142 id: NL84574.068.23 briefTitle: Glucose and Glycogen Dynamics in Prediabetes acronym: GGD overallStatus: RECRUITING date: 2024-02-20 date: 2025-07 date: 2025-07 date: 2024-03-19 date: 2024-04-09 name: Maastricht University Medical Center class: OTHER briefSummary: The goal of this observational study is to investigate changes in nocturnal and postprandial glucose and glycogen metabolism in individuals with impaired fasting glucose and impaired glucose tolerance compared to healthy, non-diabetic, overweight participants (15 per group). In addition, it will be investigated if reducing gluconeogenesis, by using the challenge agent Acipimox, in people with prediabetes can increase glucose tolerance and fat oxidation by increased reliance on hepatic glycogen. The main questions this project aims to answer are:

* whether there are differences in nocturnal glucose/glycogen metabolism in individuals with impaired fasting glucose, impaired glucose tolerance and healthy overweight controls.
* whether there are differences in postprandial glucose/glycogen metabolism in individuals with impaired fasting glucose, impaired glucose tolerance and healthy overweight controls.

Participants will visit the university for a screening visit and a visit with overnight stay for measurements of gluconeogenesis, glycogen, and substrate oxidation. A subgroup will receive \[18F\]-FDG to assess tissue-specific postprandial glucose uptake. Thereafter, 20 prediabetic individuals will follow a 4-day treatment with acipimox to decrease gluconeogenesis, followed by a second overnight visit with similar measurements as mentioned for the first visit. conditions: Pre Diabetes studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 45 type: ESTIMATED name: Acipimox 250 mg Oral Capsule measure: Hepatic and muscle glycogen measured by 13Carbon-Magnetic resonance spectroscopy (13C-MRS) measure: Whole body gluconeogenesis determined by deuterated water measure: Postprandial hepatic and muscle glucose uptake determined by Fluorodeoxyglucose-Positron emission tomography ([18F]-FDG-PET) combined with oral glucose tolerance test (OGTT) measure: Oral glucose tolerance after acipimox treatment measured by OGTT measure: Hepatic glycogen after acipimox treatment measured by 13C-MRS measure: Whole body gluconeogenesis after acipimox treatment determined by deuterated water measure: Hepatic acetylcarnitine as a measure for hepatic gluconeogenesis determined by H-MRS measure: Substrate oxidation (fat and carbohydrate oxidation) determined by indirect calorimetry measure: Dynamic water relaxation measurements with 1H-MRS (surrogate glycogen) measure: Anthropometric measurements measure: Body composition determined by Bodpod sex: ALL minimumAge: 45 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maastricht University status: RECRUITING city: Maastricht state: Limburg zip: 6229ER country: Netherlands name: Kay Roumans, PhD role: CONTACT phone: 433882124 phoneExt: 31 email: k.roumans@maastrichtuniversity.nl lat: 50.84833 lon: 5.68889 hasResults: False

 nctId: NCT06317129 id: CP000005 briefTitle: Clinical Feasibility Study of the BariTon™ System in Obese Patients overallStatus: RECRUITING date: 2024-01-18 date: 2024-10-31 date: 2026-01-31 date: 2024-03-19 date: 2024-03-19 name: BariaTek Medical class: INDUSTRY briefSummary: Safety evaluation of BariaTek Medical gastric restriction and biliodigestive diversion device. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Endoscopic gastric restriction and biliodigestive diversion measure: Safety of the BariTon™ measure: Safety of the BariTon™ measure: Safety of the BariTon™ measure: Safety of the BariTon™ measure: Efficacy of the BariTon™ measure: Efficacy of the BariTon™ measure: Efficacy of the BariTon™ measure: Efficacy of the BariTon™ measure: Efficacy of the BariTon™ measure: Efficacy of the BariTon™ sex: ALL minimumAge: 25 Years maximumAge: 60 Years stdAges: ADULT facility: Republican Specialized Scientific and Practical Medical Center of Surgery named after V. Vakhidov status: RECRUITING city: Tashkent country: Uzbekistan name: Abdurashid Abdukarimov, Dr role: CONTACT lat: 41.26465 lon: 69.21627 hasResults: False

 nctId: NCT06317116 id: 2023/09-14 briefTitle: Examining the Relationship Between Core Muscles and Bladder Issues in Children overallStatus: ENROLLING_BY_INVITATION date: 2023-09-29 date: 2024-09-29 date: 2025-03-01 date: 2024-03-19 date: 2024-03-19 name: Izmir Bakircay University class: OTHER name: Dokuz Eylul University name: Ege University Medical School name: The Scientific and Technological Research Council of Turkey briefSummary: The goal of this observational study is to learn about functional bladder problems in children. The main questions it aims to answer are:

* Does bladder symptoms in children have an effect on core muscles?
* How do core muscles change based on an increase or decrease in these symptoms? conditions: Lower Urinary Tract Symptoms conditions: Skeletal Muscle studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: Dysfunctional Voiding and Incontinence Scoring System (DVAISS) measure: Bladder and Bowel Dysfunction Questionnaire (BBDQ) measure: Childhood Bladder and Bowel Dysfunction Questionnaire (CBBDQ) measure: Bladder Diary measure: Bowel Diary measure: Superficial Electromyography (EMG) measure: Ultrasonography (USG) sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Ege University Hospital Pediatric Urology Outpatient Clinic city: İzmir country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06317103 id: WAY-CTP-WME01-MSM briefTitle: A Clinical Trial to Evaluate the Sensitivity and Specificity of "WAYMED Endo" Compared to the Endoscopists in Classifying Early Gastric Cancer (EGC) Based on the Depth of Invasion in Endoscopic Images overallStatus: COMPLETED date: 2023-08-22 date: 2023-08-22 date: 2023-08-22 date: 2024-03-19 date: 2024-03-19 name: WAYCEN Inc class: INDUSTRY briefSummary: The purpose of this clinical trial is to prove that the prediction capability of 'WAYMED endo' is superior to that of the endoscopists in classifying EGC based on the depth of invasion categories in gastro-endoscopic images.

The computer-aided detection·diagnosis software is an Artificial Intelligence (AI) software used to assist medical specialists in diagnostic decisions by automatically classifying EGC based on the depth of invasion categories in gastro-endoscopic images and displaying the results and possibilities on the User Interface (UI). conditions: Early Gastric Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 653 type: ACTUAL name: WADYMED endo name: Control group (the endoscopists) measure: Clinical Sensitivity in classifying early gastric cancer (EGC) based on the depth of invasion (%) measure: Clinical Specificity in classifying early gastric cancer (EGC) based on the depth of invasion (%) measure: Accuracy in classifying the depth of invasion categories ("Mucosa" or "Submucosa") for early gastric cancer (%) sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yonsei University Gangnam Severance Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06317090 id: S59813-2 briefTitle: Vertical GBR LPRF Block vs. Autogenous Bone With DBBM overallStatus: COMPLETED date: 2018-07-02 date: 2023-03-01 date: 2023-03-01 date: 2024-03-19 date: 2024-03-19 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: split-mouth RCT, 25 months follow up. GBR protocol with LPRF as grafting material in the test group and autogenous bone with DBBM as grafting material in the control group. conditions: Alveolar Bone Resorption studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: split-mouth 2 arm RCT primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: neither the patient, nor the outcome assessor was aware at which side which grafting material was used whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 6 type: ACTUAL name: guided bone regeneration measure: bone volume as measured on CBCT scans measure: Buccal bone thickness around the implants measure: Buccal bone thickness around the implants measure: Cumulative survival rate of the implants measure: rates and types of complications sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Leuven city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06317077 id: I5-R1-C-FA briefTitle: Investigation of the Accordance Between Event Detection of prismaLINE Devices and Polysomnography Using Full Face Masks acronym: EventLAB FF overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-05-15 date: 2025-05-15 date: 2024-03-19 date: 2024-03-19 name: Löwenstein Medical Technology GmbH & Co. KG class: INDUSTRY briefSummary: Sleep-related breathing disorders are highly prevalent and are usually treated with positive airway pressure (PAP) therapy. To determine the quality of therapy, PAP therapy devices measure the frequency of residual breathing events. For this purpose, breathing events of different classes are detected, counted and identified.

This clinical investigation aims to evaluate the performance of prismaLINE devices based on the accuracy of the apnea-hypopnea index (AHI) recorded in the devices. During the PAP titration night, the AHI is similarly detected via polysomnography (PSG) device and a subsequent manual scoring of the recorded PSG data. The validation of the device AHI accuracy refers to the alignment with the manually scored AHI.

Further goals of this clinical investigation are the confirmation of safety of the prismaLINE devices, the confirmation of performance and safety of LM full face masks (full face masks of the manufacturer Löwenstein Medical Technology), as well as the investigation of the influence of LM full face masks on therapy quality.

The most relevant inclusion criteria are diagnosis of a sleep-related breathing disorder and indication for therapy with continuous positive airway pressure (CPAP). Treatment takes place with prismaLINE PAP therapy devices in combination with LM full face masks. conditions: Sleep Apnea Syndromes studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: PAP therapy setting name: exclusive use of Löwenstein Medical full face masks measure: Delta AHI [n/h]= Difference of device AHI (prismaLINE devices of the type WM100TD) and the manual scored AHI of polysomnographic data identified in the Matlab-based SOMNOmat tool measure: N_AE device [n]= number and severity of occurred (predictable) adverse events and (predictable) adverse device effects, counted during study duration measure: Mask fit score= Leakage, pressure points, stable pressure level, comfort determined via questionnaire measure: N_AE mask [n]= number and severity of occurred (predictable) adverse events and (predictable) adverse device effects, counted during study duration measure: Delta AI [n/h]= difference of apnea-indices (obstructive/central/mixed) between the therapy device and the manually evaluated PSG data identified in the Matlab-based tool SOMNOmat measure: Delta HI [n/h]= difference of hypopnea-indices (obstructive/central) between the therapy device and the manually evaluated PSG data identified in the Matlab-based tool SOMNOmat measure: Delta Event_individual [n]= difference of the number (with time, duration, type) of residual breathing events (apneas/hypopneas) device vs. PSG identified in the Matlab-based tool SOMNOmat measure: N_influenced phases [n]= number (with time, duration, type) of phases with significant deviations between the synchronized device and PSG files identified in the Matlab-based tool SOMNOmat measure: Delta AHI_1A [n/h]= difference between apnea indices using scoring rule 1A from AASM manual version 3.0 measure: Delta AHI_1B [n/h]= difference between apnea indices using scoring rule 1B from AASM manual version 3.0 measure: Delta AHI_mean [n/h]= difference between apnea indices using mean of scoring rule 1A and 1B from AASM manual version 3.0 (AHI_1A + AHI_1B)/2 measure: Delta AHI_Routine [n/h]= difference between unmachined apnea indices of device and PSG measure: N_impact factors [n]= number and type of factors that can increase the risk for sleep related breathing disorders like comorbidities and smoking measure: corr_flow-sleep= correlation between flow signal and sleep state measure: corr_marker= correlation between diagnostic sleep apnea syndrom markers with medical history data, biomarkers of the diagnostic night, therapy pressure and sleep stage sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Krankenhaus Bethanien city: Solingen state: NRW zip: 42699 country: Germany name: Marc Treml, Dr. role: CONTACT lat: 51.17343 lon: 7.0845 hasResults: False

 nctId: NCT06317064 id: LMRC-Aprepitant-Pain-01 briefTitle: Diagnostic and Therapeutic Potential of Substance P/ NK1R Receptor in Primary Dysmenorrhea overallStatus: COMPLETED date: 2023-01-15 date: 2023-10-31 date: 2024-01-31 date: 2024-03-19 date: 2024-03-19 name: Lahore Medical Research Center, LLP class: INDUSTRY briefSummary: Dysmenorrhea is characterized as excruciating menstrual cramps of uterine origin and is one of the most prevalent gynecological illnesses. Substance P (SP) and NK1R mediate the symptoms of various pain disorders with chronic and/or neuropathic pain. Objective: To evaluate diagnostic and therapeutic potential of Substance P/ NK1R receptor in primary dysmenorrhea. Study Design: This was a randomized controlled trial which took place at Lahore Medical Research Center from April 2023 to August 2023. Non-probability convenient sampling techniques was used for sampling. A total of 40 female participants was included in the study who met specific criteria for inclusion. The study comprised of three phases, Phase 1 (Before medication), Phase 2 (NSAIDs) and Phase 3(Dexamethasone + Aprepitant). 10 females with no dysmenorrhea participated as controls. The study duration spanned three menstrual cycles. 20 dysmenhorric and 6 controls were analyzed for NK1R levels. Several assessment tools were also used in the study, conditions: Primary Dysmenorrhea studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Group 1: Controls 10 females with no dysmenorrhea participated as controls. Group 2: NSAIDS All 30 participants in this group used NSAIDs (Non-steroidal Anti-Inflammatory Drugs), during their dysmenorrhea period. Same patients from phase 2 (n=30) in next cycle received NK1R antagonist "Dexamethasone (6mg) + Aprepitant (80mg)" for 2 days. primaryPurpose: TREATMENT masking: NONE count: 40 type: ACTUAL name: Ibuprofen and Aprepitant measure: Visual Analogue Scale Score (Pain scale) measure: Mini Nutritional Assessment (MNA) Score measure: DASS-21 (Depression Anxiety Stress Scale) measure: Pictorial Blood Loss Assessment Chart (PBAC) sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Prof. Dr. Riffat Mehboob city: Lahore state: Punjab zip: 54000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06317051 id: OPTIMAR briefTitle: Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART) acronym: OPTIMAR overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-07 date: 2026-12 date: 2024-03-19 date: 2024-03-19 name: Kirby Institute class: OTHER_GOV briefSummary: People with HIV are at a higher risk of cardiovascular diseases (CVD) due to the effects of the virus and its treatment. Integrase strand transfer inhibitors (INSTIs), a common HIV treatment, are associated with increased CVD risk and metabolic issues, such as weight gain and high blood pressure. Sodium-glucose cotransporter 2 (SGLT2) inhibitors, however, have been working well in reducing CVD events and hospitalizations due to heart failure, irrespective of diabetes presence. They also help in reducing weight and blood pressure. Pitavastatin has shown to work in lowering CVD events in people with HIV, but its availability is limited. This benefit is thought to be common to all statins, but this has not yet been confirmed. This study will examine the impact of dapagliflozin vs. placebo on metabolic parameters in people with HIV with high metabolic risk who are on INSTI-based ART. conditions: HIV Infections conditions: Weight Gain studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: Dapagliflozin 10mg Tab name: Pitavastatin 4 Mg Oral Tablet name: Rosuvastatin and Ezetimibe name: Placebo measure: To assess the impact of dapagliflozin vs. placebo on weight reduction measure: To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe on low-density lipoproteins (LDL) concentration measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on body mass index (BMI )- weight and height will be combined to report BMI in kg/m^2 measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on waist (cm) to hip (cm) ratio measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on waist (cm) to height (cm) ratio measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on systolic and diastolic blood pressure (mm Hg) measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on Atherosclerotic cardiovascular disease risk score (ASCVD) - calculation of a person's10-year risk (%) of having a cardiovascular problem. measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on fasting lipids including: Total Cholesterol (mmol/L), LDL (mmol/L), High-Density Lipoproteins (HDL) (mmol/L), Triglycerides (mmol/L) measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on fasting glucose (mmol/L) measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on haemoglobin A1C (%) measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on measures of fatty liver disease: Liver Function Tests - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (U/L), FibroScan (kPa) measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on inflammatory biomarkers (tested centrally on stored research samples) measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on Serious adverse events. measure: To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on fasting lipids including: Total Cholesterol (mmol/L), LDL (mmol/L), High-Density Lipoproteins (HDL) (mmol/L), Triglycerides (mmol/L) measure: To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on Atherosclerotic cardiovascular disease risk score (ASCVD) - calculation of a person's10-year risk (%) of having a cardiovascular problem. measure: To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on inflammatory biomarkers (tested centrally on stored research samples) measure: To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on serious adverse events sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06317038 id: 89814415 briefTitle: To Evaluate the Performance of Total 30 (Lehifilcon A) Contact Lenses in Patients Using Digital Devices for Greater Than 8 Hours Per Day 5 Days Per Week Based on Subjective Reported Data. overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2024-11 date: 2025-01 date: 2024-03-19 date: 2024-03-27 name: Tauber Eye Center class: OTHER name: Alcon Research briefSummary: To evaluate the performance of Total 30® (lehfilcon A) contact lenses in patients using digital devices for greater than 8 hours per day 5 days per week based on subjective reported data. conditions: Eye Strain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open label Observation primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: Total 30 Contact Lens measure: Likert question about comfort satisfaction while wearing Total 30 contact lenses on a typical day (> 13 hours of daily wear) after 1 month of wear and heavy digital device usage (>8 hours daily wear). measure: Likert responses to insertion comfort and overall vision, and heavy digital device use on a typical day after 1 month of wear. measure: Results of subjective ratings of patients using Total 30 lenses and heavy digital device usage with VAS diary questionnaire. measure: Report on total daily wear time and digital device usage. sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06317025 id: SHOUFA2022-2Z-2039 briefTitle: Design and Development of Multi-modal Intelligent Anesthesia Monitoring System overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2025-12 date: 2024-03-19 date: 2024-03-19 name: Beijing Chao Yang Hospital class: OTHER briefSummary: This project integrates the characteristics of electroencephalo-graph（EEG）, cerebral oxygen, blood pressure, heart rate, etc., based on nonlinear theory and neural oscillation, large sample data and machine learning theory, to develop a multi-modal monitoring system suitable for domestic patients, taking into account changes in sedation, analgesia, cerebral hemodynamics and other factors, regardless of patient age and type of general anesthesia drugs. conditions: Anesthesia studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 330 type: ESTIMATED name: Multi-modal Intelligent Anesthesia Monitoring System measure: the depth of anesthesia (too deep or too shallow) measure: EEG characteristics of loss of consciousness induced by different general anesthesia drugs measure: Characteristics of perioperative neurovascular coupling sex: ALL maximumAge: 85 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06317012 id: 0407-03/2022 briefTitle: Computer-Aided Design/Manufacturing for Le Fort I Osteotomy and 3D-customized Titanium Plate in Orthognathic Surgery overallStatus: COMPLETED date: 2022-05-01 date: 2023-05-30 date: 2023-06-30 date: 2024-03-19 date: 2024-03-19 name: Hams Hamed Abdelrahman class: OTHER briefSummary: Background: In orthognathic surgery, virtual planning is gradually taking over in clinical practice. To start with, virtual surgery planning (VSP) is believed to be less time-consuming and less expensive than conventional surgery planning (CSP). Moreover, the improved visualization of craniofacial deformities, such as occlusal canting and asymmetries, is a further advantage. Aim: To assess the result of Le Fort I osteotomy using CAD/CAM and 3Dcustomized titanium plate with virtual planning in orthognathic surgery. Materials and Methods: 8 patients with vertical maxillary excess will be included in the study. Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate will be done for the study group. All patients will be followed clinically and radiographically for one month. conditions: Le Fort; I studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ACTUAL name: Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate measure: Change in pain measure: change in edema measure: Change in post operative osteotomy position sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Alexandria Faculty of Dentistry city: Alexandria country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False

 nctId: NCT06316999 id: 23-012169 briefTitle: Intestinal Ultrasound for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-06 date: 2025-06 date: 2024-03-19 date: 2024-03-19 name: Mayo Clinic class: OTHER briefSummary: Intestinal ultrasound (IUS) has been studied in the evaluation of inflammatory bowel disease (IBD) and is increasingly used as a non-invasive, easy to use, cost-effective tool for point-of-care to assess disease activity and more recently to predict response to treatment. However, there is a paucity of data on the use of IUS specifically for ulcerative colitis (UC) patients with an ileal pouch-anal anastomosis (IPAA). conditions: Ulcerative Colitis conditions: Pouchitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: Intestinal Ultrasound measure: Diagnostic accuracy of intestinal ultrasound (IUS) for pouchitis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States name: Darrell Pardi, MD, MS role: CONTACT phone: 507-284-2511 email: pardi.darrell@mayo.edu lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06316986 id: 2023-A02294-41 briefTitle: Performance of the NGPOD® Device in Verifying the Correct Position in the Stomach of the Naso- or Oro- Gastric Tube in Intensive Care. acronym: NGPOD overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-03-19 date: 2024-03-19 name: Fondation Hôpital Saint-Joseph class: OTHER briefSummary: In the ICU, scientific societies recommend starting enteral nutrition within 48 hours of admission, if oral nutrition is not available, in order to limit undernutrition. In patients who are sedated, have swallowing problems or cannot ensure adequate caloric intake, it is essential to insert a feeding tube, usually a nasogastric or orogastric tube for the first few weeks.

Placement of a naso- or oro-gastric tube in the intensive care unit is a frequent procedure, and considered to be straightforward. It is usually performed blindly, at the patient's bedside, by a nurse or doctor, according to a departmental protocol or the recommendations of learned societies.

Nevertheless, a number of complications have been reported with naso- or oro-gastric tubes, linked in particular to a route outside the digestive tract : malpositioning/coiling of the tube, epistaxis, sinusitis. The most frequent and potentially severe complications are malpositions in the tracheobronchial tree.

Radiographic control is currently considered in France and by certain learned societies to be the reference method for verifying correct positioning of the probe in the stomach (at the prepyloric antral level). However, thoracic radiography has a number of drawbacks : In intensive care risk of accidental displacement of other medical devices,irradiation, difficulty of interpretation, delay in obtaining the image, time-consuming work for qualified personnel.

An alternative technique using the NGPOD device is proposed as a method of checking the correct positioning of the probe in the stomach. This system enables immediate, rapid (15 seconds), simple and automatic testing at the patient's bedside. The device provides a visual indication of the pH detected at the tip of the gastric tube. The test result is given in binary form: Yes (green signal, probe in stomach) / No (red signal, probe incorrectly positioned).

Study hypothesis and prospects: To make an initial estimate of the sensitivity and specificity of the NGPOD system for checking the positioning of the naso- or oro-gastric tube in the stomach, compared with the recognized gold standard, the chest X-ray. conditions: Intensive Care conditions: Nutrition studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: pH indication with NGPOD measure: Ability of the NGPOD device to detect correct positioning of the gastric tube. measure: Probe malpositioning measure: Time to validate correct positioning of gastric tube measure: Evaluation of the "simplicity" of the procedures for using and interpreting the NGPOD system measure: x-ray manipulators time measure: Adverse events occurring during the study period measure: Ability of the NGPOD device to detect correct gastric tube positioning in a subgroup of patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Marie Lannelongue city: Le Plessis-Robinson zip: 92350 country: France name: Audrey IMBERT role: PRINCIPAL_INVESTIGATOR lat: 48.78889 lon: 2.27078 hasResults: False

 nctId: NCT06316973 id: CS-1103-01 id: U01DA053054 type: NIH link: https://reporter.nih.gov/quickSearch/U01DA053054 briefTitle: A Clinical Study to Evaluate the Safety of CS-1103 in Healthy Participants overallStatus: RECRUITING date: 2024-02-07 date: 2024-07 date: 2024-07 date: 2024-03-19 date: 2024-03-19 name: Clear Scientific, Inc. class: INDUSTRY name: National Institute on Drug Abuse (NIDA) briefSummary: The purpose of this Phase 1a study is to evaluate safety, tolerability, and pharmacokinetics (PK) of single, ascending doses of CS-1103, administered by intravenous (IV) infusion in healthy participants. conditions: Substance Use Disorders conditions: Methamphetamine Abuse conditions: Methamphetamine Intoxication studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, Double-Blind, Placebo-Controlled, Single Center Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CS-1103 Following Single, Ascending Intravenous Dose Administration in Healthy Participants primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: CS-1103 name: Sterile Saline measure: Number of participants with treatment-related adverse events (AEs) assessed by physical examinations measure: Number of participants with treatment-related adverse events (AEs) assessed by vital signs measure: Number of participants with treatment-related adverse events (AEs) assessed by electrocardiograms (ECGs) measure: Number of participants with treatment-related adverse events (AEs) assessed by laboratory parameters measure: Time course of CS-1103 blood and urine concentrations sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Dr. Vince Clinical Research status: RECRUITING city: Overland Park state: Kansas zip: 66212 country: United States name: Lori Adriano role: CONTACT phone: 913-333-3000 name: Steven Hull, M.D. role: PRINCIPAL_INVESTIGATOR lat: 38.98223 lon: -94.67079 hasResults: False

 nctId: NCT06316960 id: AVACBFKIT briefTitle: Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation overallStatus: RECRUITING date: 2024-03 date: 2026-03 date: 2027-03 date: 2024-03-19 date: 2024-03-19 name: Children's Hospital of Soochow University class: OTHER briefSummary: The purpose of this study is to evaluate the efficacy and safety of avapritinib in relapsed or refractory pediatric core binding factor acute myeloid leukemia with KIT mutation. conditions: AML, Childhood conditions: Relapse/Recurrence conditions: Refractory AML conditions: Core Binding Factor Acute Myeloid Leukemia conditions: C-KIT Mutation studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Avapritinib name: Azacitidine Injection name: Decitabine Injection name: Idarubicin Hydrochloride name: Cytarabine name: Granulocyte Colony-Stimulating Factor measure: Composite remission rate (CRc) measure: Overall survival measure: Progression-free survival sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: First Affiliated Hospital Of University of Science and Technology of China status: NOT_YET_RECRUITING city: Hefei state: Anhui zip: 230000 country: China name: Chun Li, MD,PhD role: CONTACT phone: +86-13865992676 email: lichun1230@sohu.com lat: 31.86389 lon: 117.28083 facility: The Second Hospital of Anhui Medical University status: NOT_YET_RECRUITING city: Hefei state: Anhui zip: 230000 country: China name: Ninglin Wang, MD role: CONTACT phone: +86-13721113063 email: zwnltt@126.com lat: 31.86389 lon: 117.28083 facility: Guangzhou Women and Children Medical Center status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Hua Jiang, MD, PhD role: CONTACT phone: +86-13533330985 email: jiang_hua18@sina.cn lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Guangxi Medical University status: NOT_YET_RECRUITING city: Nanning state: Guangxi zip: 530000 country: China name: Ning Liao, MD role: CONTACT phone: +86-13978812808 email: ln12808@163.com lat: 22.81667 lon: 108.31667 facility: Kaifeng Children's Hospital status: NOT_YET_RECRUITING city: Kaifeng state: Henan zip: 475000 country: China name: Jixia Luo, MD role: CONTACT phone: +86-13592146539 email: luojixia@163.com lat: 34.7986 lon: 114.30742 facility: The First Affiliated Hospital of Zhengzhou University status: NOT_YET_RECRUITING city: Zhengzhou state: Henan zip: 450052 country: China name: Yufeng Liu, MD,PhD role: CONTACT phone: +86-13673666608 email: lyf6012@126.com lat: 34.75778 lon: 113.64861 facility: Third Xiangya Hospital of Central South University status: NOT_YET_RECRUITING city: Changsha state: Hunan zip: 410000 country: China name: Minghua Yang, MD role: CONTACT phone: +86-13973135843 email: yamahua123@163.com lat: 28.19874 lon: 112.97087 facility: XiangYa Hospital Central South University status: NOT_YET_RECRUITING city: Changsha state: Hunan zip: 410008 country: China name: Liangchun Yang, MD,PhD role: CONTACT phone: +86-13974927514 email: yangliangchung@163.com lat: 28.19874 lon: 112.97087 facility: Children's Hospital of Soochow University status: RECRUITING city: Suzhou state: Jiangsu zip: 215000 country: China name: Shaoyan Hu, MD, PhD role: CONTACT phone: +86-13771835430 email: hsy139@126.com name: Li Gao, MD role: CONTACT phone: +86-15821963190 email: joygaoli@163.com name: Shaoyan Hu, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Peifang Xiao, MD role: PRINCIPAL_INVESTIGATOR name: Li Gao, MD role: SUB_INVESTIGATOR name: Jun Lu, MD role: SUB_INVESTIGATOR name: Jie Li, MD role: SUB_INVESTIGATOR lat: 31.30408 lon: 120.59538 facility: Xuzhou Children's Hospital status: NOT_YET_RECRUITING city: Xuzhou state: Jiangsu zip: 221000 country: China name: Qi An, MD role: CONTACT phone: +86-13814422329 email: anqi1974@sina.com lat: 34.18045 lon: 117.15707 facility: Qilu Hospital of Shandong University status: NOT_YET_RECRUITING city: Jinan state: Shandong zip: 250000 country: China name: Xiuli Ju, MD,PhD role: CONTACT phone: +86-13869192944 email: shellysdcn@hotmail.com lat: 36.66833 lon: 116.99722 facility: Children's Hospital Of Fudan University status: NOT_YET_RECRUITING city: Shanghai state: Shanghai zip: 200000 country: China name: Xiaowen Zhai, MD, PhD role: CONTACT phone: +86-18017590808 email: zhaixiaowendy@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06316947 id: FMCH-2024-32723 briefTitle: Developing and Pilot Testing an Intervention to Reduce Household Shisha Smoke Exposure Within Somali Homes overallStatus: NOT_YET_RECRUITING date: 2025-02-01 date: 2025-10-01 date: 2026-01-01 date: 2024-03-19 date: 2024-03-19 name: University of Minnesota class: OTHER briefSummary: Previous qualitative research among Somali American adults in Minnesota have identified high levels of hookah or shisha (hereafter shisha) use in Somali households. Household shisha use exposes all family members, including children, to secondhand smoke (SHS) that contains toxins that can cause many different acute and chronic disease, including increased levels of several cancers such as lung, bladder, and oral cancers. Despite the high levels of shisha use, gaps in the knowledge of the risks of shisha use and how to mitigate the potential harmful health consequences of shisha use exist among Somali Americans.

This study aims to pilot test the feasibility of a newly developed CHW-delivered intervention to reduce home shisha SHS exposure with n=15 Somali families. Pre-/post-measurements of family members' (1 adult and 1 child) urine or salivary cotinine levels will be obtained along with a brief pre-/post-survey to characterize household tobacco use and the presence of home smoke-free rules. conditions: Shisha studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: a feasibility pilot of the new CHW-delivered intervention to reduce home shisha SHS exposure with n=15 Somali families. primaryPurpose: OTHER masking: NONE count: 15 type: ESTIMATED name: CHW-delivered intervention measure: Recruitment rate measure: Retention rate measure measure: pre-/post- survey completion rates measure: pre-/post- biospecimen completion rates measure: shisha use changes measure: tobacco product use changes measure: smoke-free home rules measure: the cotinine levels of parents and children. sex: ALL minimumAge: 6 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06316934 id: IRB202302181 briefTitle: Lavender Aromatherapy to Decrease Anxiety/Pain Perception During Office Hysteroscopy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-07 date: 2024-08 date: 2024-03-19 date: 2024-04-05 name: University of Florida class: OTHER briefSummary: Office hysteroscopy is an invaluable practice to treat a myriad of gynecological processes. However, a limiting factor is the perceived pain and anxiety. In a randomized pilot study, treatment with lavender aromatherapy will significantly decrease the stress/anxiety levels associated with office hysteroscopy, as measured on a visual analogue scale and the Hospital Anxiety and Depression Scale (HADS) questionnaire when compared to control subjects receiving distilled water placebo. conditions: Anxiety conditions: Pain, Procedural studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The participants will be randomized into two arms - aromatherapy or placebo. The protocol will be the same for the two arms except that the towel held over the mouth will be scented either with lavender essential oil or distilled water. The clinic nurse will prepare the scented towel and hand it to the participant according to the random assignment. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE maskingDescription: Randomization will be performed once the patient agrees to participate and has signed the consent document. A random number generator will be used to designate each arm of the study. Odd numbers will be assigned to the aromatherapy arm while the even numbers will be assigned to the placebo arm. Each assignment will be placed into a sealed opaque numbered enveloped. After the participant has agreed to participate, the clinic nurse will open the envelope to identify the study arm. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Lavandula angustifolia, Aura Cacia name: Placebo measure: Determine the change in pain scores from baseline to immediate post-procedure. measure: Determine change in anxiety scores from baseline to immediate post-procedure. measure: Determine level of satisfaction after the procedure sex: FEMALE minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Florida city: Gainesville state: Florida zip: 32610 country: United States name: Tiffani-Amber Miller, MD role: CONTACT phone: 352-273-7660 email: tiffani12@ufl.edu name: Amira Quevedo, MD role: CONTACT phone: 352-273-7660 email: amiraquevedo@ufl.edu lat: 29.65163 lon: -82.32483 hasResults: False

 nctId: NCT06316921 id: TCHIRB-11003008-E briefTitle: Epidural PCA on Pain Relief After L-spine Surgery overallStatus: COMPLETED date: 2021-06-01 date: 2021-12-31 date: 2021-12-31 date: 2024-03-19 date: 2024-03-19 name: Taipei City Hospital class: OTHER_GOV briefSummary: This study aimed to evaluate the effect of epidural patient-controlled analgesia (PCA) on postoperative pain relief after lumbar spine surgeries. The eligible patients received two types of postoperative pain management: PCA and standard pain treatment. Comparisons between the two groups were made in terms of postoperative pain level. conditions: Pain, Postoperative conditions: Lumbar Spine Degeneration conditions: Analgesia, Patient-Controlled conditions: Epidural Anesthesia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 209 type: ACTUAL name: Epidural patient-controlled analgesia name: Standard postoperative pain management measure: Pain degree measure: The number of morphine injections measure: Length of hospitalization measure: Drainage amount sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei City Hospital city: Taipei country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06316908 id: ERC-2019/A187 briefTitle: Permanent Celiac Plexus Block: Comparison of Pain Score in Unilateral and Bilateral Posterior Percutaneous Approach overallStatus: COMPLETED date: 2020-02-25 date: 2022-07-15 date: 2023-03-15 date: 2024-03-19 date: 2024-03-19 name: Sindh Institute of Urology and Transplantation class: OTHER briefSummary: The goal of this prospective, interventional, non-randomized study was to compare pain score in unilateral and bilateral posterior percutaneous neurolytic celiac plexus block (NCPB) in upper abdominal cancer patients.

The main questions it aimed to answer are:

1. Whether unilateral or bilateral NCPB technique has a better pain relief
2. Was there any difference in terms of complication rates between these two approaches All participants were having upper abdominal cancer whether operated or non-operable cancer were given a unilateral or bilateral neurolytic celiac plexus block.

Pain scores and adverse events at multiple time points post-procedure were recorded. conditions: Abdominal Cancer conditions: Cancer Pain conditions: Cancer of Pancreas studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Unilateral Approach Group: Patients in this group have received a unilateral percutaneous posterior approach for NCPB. The procedure was performed under fluoroscopic guidance.

Bilateral Approach Group: Patients in this group have undergone a bilateral percutaneous posterior approach for NCPB, following the same procedural guidance. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ACTUAL name: Unilateral Neurolytic Celiac Plexus Block with Absolute Alcohol name: Bilateral Neurolytic Celiac Plexus Block with Absolute Alcohol measure: Pain Score using the Visual Analog Scale measure: Change in Mean Arterial Pressure measure: Incidence of Patient-Reported Nausea Feeling measure: Incidence of Vomiting sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sindh Institute of Urology and Transplantation city: Karachi state: Sindh zip: 74200 country: Pakistan lat: 24.8608 lon: 67.0104 hasResults: False

 nctId: NCT06316895 id: S2023-706 briefTitle: The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-04-01 date: 2029-12-31 date: 2024-03-19 date: 2024-03-20 name: Chinese PLA General Hospital class: OTHER briefSummary: 1. To evaluate the clinical outcomes of ultrasound-guided thermal ablation and thyroid surgery for the treatment of papillary thyroid carcinoma;
2. To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of papillary thyroid carcinoma; conditions: Papillary Thyroid Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3772 type: ESTIMATED name: thyroid surgery name: ultrasound-guided thermal ablation measure: rate of disease progression measure: Rate of complications measure: Rate of tumor disappearance sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06316882 id: ROCGAS 01 id: ROGCAS Study type: OTHER domain: ULSNA briefTitle: Opportunistic Gastric Cancer Screening acronym: ROCGAS overallStatus: RECRUITING date: 2023-02-03 date: 2024-07-31 date: 2024-12-31 date: 2024-03-19 date: 2024-03-19 name: Unidade Local De Saúde Do Norte Alentejano class: OTHER name: NOVA Medical School briefSummary: Endoscopic screening of gastric cancer combined with screening colonoscopy conditions: Gastric Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 139 type: ESTIMATED name: Screening endoscopy measure: number of gastric adenocarcinoma measure: number of pre-malignant lesions measure: Costs of screening endoscopy measure: Socio-demographic characteristics of population in screening program sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ULSNA status: RECRUITING city: Portalegre zip: 7300-853 country: Portugal name: Beatriz Mourato, MD role: CONTACT phone: 00351910311213 email: 2091@ulsna.min-saude.pt name: Beatriz Mourato, MD role: PRINCIPAL_INVESTIGATOR name: Guilherme Santos, MD role: PRINCIPAL_INVESTIGATOR name: Sara Morais, MD role: SUB_INVESTIGATOR name: Nuno Pratas, MD role: PRINCIPAL_INVESTIGATOR name: Filipa Taré, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29379 lon: -7.43122 hasResults: False

 nctId: NCT06316869 id: STVi briefTitle: Noninvasive Prediction of Portal Hypertension in Cirrhosis Using Sound Touch Viscoelastography overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-03-31 date: 2025-03-31 date: 2024-03-19 date: 2024-03-19 name: First Affiliated Hospital of Wenzhou Medical University class: OTHER briefSummary: The objective of this observational study is to investigate and validate the utility of the Sound Touch Viscoelastography(STVi) technique in patients with liver cirrhosis for noninvasive prediction of Portal hypertension (PH). The primary research questions it seeks to address are as follows:

* What is the correlation between the liver STVi index and Portal Venous Pressure Gradient (HVPG)?
* Is STVi an available tool to non-invasively predict PH in patients with liver cirrhosis? And the effectiveness and practicality of STVi will be validated.
* To establish a predictive model for Clinically Significant Portal Hypertension (CSPH) utilizing liver STVi index as the primary indicator.

The HVPG is considered as the gold standard in our study and STVi was employed to quantify the STVi index of the liver in patients with liver cirrhosis. Researchers will compare the two patients groups, HVPG≥10 mmHg and HVPG\<10 mmHg, to see the usage of STVi in the noninvasive prediction of PH. conditions: Portal Hypertension conditions: Cirrhosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 216 type: ESTIMATED measure: STVi index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the First Affiliated Hospital the First Affiliated Hospital city: Wenzhou state: Zhejiang zip: 325006 country: China lat: 27.99942 lon: 120.66682 hasResults: False

 nctId: NCT06316856 id: BJGBYY-IIT-LCYJ-2024-002 briefTitle: CD5 Chimeric Antigen Receptor (CAR) T Cells in Subjects With Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-12-31 date: 2026-06-30 date: 2024-03-19 date: 2024-04-09 name: Beijing GoBroad Hospital class: OTHER briefSummary: This is a single-center, open-label, non-randomized, phase 1/2 study of anti-CD5 CAR-T cell therapy in patients with CD5+ relapsed or refractory T-cell malignancies. A bayesian optimal interval (BOIN) 12 design will be used to explore the optimal biological dose (OBD) from starting dose level 1: 1×10\^6 (±20%) to dose level 2: 2×10\^6 (±20%) in three cohorts (autologous, previous-transplant-donor or newly matched donor-derived CD5 CAR T cells). If the manufactured cells are not sufficient to meet the preassigned standard dose criteria, patients will be given infusion at a low dose level of 5×10\^5 (±20%) /kg. The primary objective is to evaluate the safety and tolerability of CD5 CAR T cell therapy in subjects, determine the OBD and recommend phase 2 dose (RP2D) in phase 1, and evaluate the efficacy of CD5 CAR T cell therapy in phase 2. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days, and the incidence and severity of adverse events (AEs) within 30 days after CD5 CAR T-cell infusion in phase 1, the best overall response (BOR) at 3 months (± 1 week) after CD5 CAR T-cell infusion in phase 2. A total number of 54 subjects will be enrolled. conditions: T-Cell Acute Lymphocytic Leukemia conditions: Acute Lymphoblastic Leukemia, in Relapse conditions: Refractory Acute Lymphoblastic Leukemia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: Autologous CD5 CAR T-cells name: Previous stem-cell transplantation (SCT) donor-derived CD5 CAR T-cells name: Newly matched donor-derived CD5 CAR T-cells measure: Phase 1-The incidence and type of dose-limiting toxicity (DLT) measure: Phase 1-The incidence and severity of adverse events (AEs) measure: Phase 2-Antitumor effect measure: Phase 1-Objective response rate (ORR) measure: Phase 1-Pharmacokinetics of CD5 CAR T cells measure: Phase 1-The incidence and severity of adverse events (AEs). measure: Phase 1-Best overall response (BOR) rate. measure: Phase 2-Objective response rate (ORR) measure: Phase 2- The incidence and severity of AEs measure: Phase 2- Progression free survival (PFS) measure: Phase 2- Overall survival (OS). sex: ALL minimumAge: 1 Year maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06316843 id: BHC202 v2.1 briefTitle: Valacyclovir Plus Celecoxib for Post-Acute Sequelae of SARS-CoV-2 acronym: PASC overallStatus: RECRUITING date: 2023-10-15 date: 2024-08 date: 2024-10 date: 2024-03-19 date: 2024-03-20 name: Bateman Horne Center class: OTHER briefSummary: To explore the safety and efficacy of daily doses of celecoxib + valacyclovir in the treatment of patients with prolonged symptoms caused by COVID-19. conditions: Long COVID conditions: PASC Post Acute Sequelae of COVID 19 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Valacyclovir celecoxib dose 1 name: Valacyclovir celecoxib dose 2 name: Placebo measure: Fatigue assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a Instrument sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bateman Horne Center status: RECRUITING city: Salt Lake City state: Utah zip: 84102 country: United States name: Lucinda Bateman, MD role: CONTACT phone: 801-359-7400 email: lbateman@batemanhornecenter.org name: Suzanne D Vernon, PhD role: CONTACT phone: (801) 359-7400 email: sdvernon@batemanhornecenter.org lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06316830 id: STUDY00000075 briefTitle: Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose acronym: Optimal Bup overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-06-30 date: 2027-04-30 date: 2024-03-18 date: 2024-03-18 name: Rhode Island Hospital class: OTHER name: Brown University briefSummary: The investigators aim to test the effectiveness of a high maintenance daily dose of buprenorphine (24 mg) for improving outcomes among patients who used fentanyl compared to the standard daily dose (16 mg).

The main question it aims to answer is: will patients who are randomly assigned to the high 24 mg maintenance dose, as compared to patients randomly assigned to the standard 16 mg maintenance dose, have improved retention in buprenorphine treatment (primary outcome), decreased use of non-prescribed opioids (secondary outcome), decreased opioid cravings (secondary outcome), and decreased risk of fatal and non-fatal opioid overdose (secondary outcome). conditions: Opioid Use Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 250 type: ESTIMATED name: Buprenorphine measure: Treatment Engagement measure: Use of non-prescribed opioids measure: Control of Opioid Cravings measure: Rate of Non-fatal or Fatal Opioid Overdose measure: Use of non-prescribed opioids sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06316817 id: 23-0184-E briefTitle: FloPatch for Prevention of Hypotension After Induction of General Anesthesia acronym: HI-CAP overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-01 date: 2026-03-02 date: 2024-03-18 date: 2024-03-18 name: Mount Sinai Hospital, Canada class: OTHER briefSummary: This study is being conducted to find out if a special device called FloPatch™, which sticks to a persons skin and uses ultrasound to check the blood flow in their neck, can tell if someone going to have low blood pressure after they get put to sleep for surgery. The investigators will be testing this in adults who are having elective non-heart surgery. Basically, the goal is to see if this device can help predict who might have low blood pressure during surgery.

Hypotension is a common side-effect of general anesthesia induction, and is related to adverse outcomes, including significantly increasing risk of one-year mortality. Even short durations of intraoperative hypotension have been associated with acute kidney injury (AKI) and myocardial injury. Myocardial injury after non-cardiac surgery (MINS) is a common postoperative complication associated with adverse cardiovascular outcomes, and intraoperative hypotension is believed to be involved in its development.

In the preoperative setting, a systematic review of 50 studies (2,260 patients) evaluating techniques to assess adult patients with refractory hypotension or signs of organ hypoperfusion found that half of all patients were fluid-responsive, pointing to volume status as a significant risk factor, while also presenting a challenge in distinguishing fluid-responders from non-responders. For surgical patients, preoperative fasting, hypertonic bowel preparations, anesthetic agents, and positive pressure ventilation all contribute to reduced effective circulating blood volume. Optimized fluid therapy remains the cornerstone of treatment of hypovolemia, with excellent effectiveness. Since the liberal use of fluids may result in fluid overload, which is associated with the development of pulmonary edema, wound infection, postoperative ileus, and anastomotic leakage, it is imperative to identify those patients who may benefit from it.

The hypothesis is that the corrected Flow Time (cFT) measured by the FloPatch will help predict hypotension after the induction of general anesthesia. conditions: Hypotension on Induction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 172 type: ESTIMATED name: FloPatch measure: Prognostic ability of preoperative common carotid artery corrected Flow Time (cFT) measurement to predict Post Induction Hypotension(PIH). measure: Passive leg raising (PLR) in predicting Post Induction Hypotension(PIH). measure: Thresholds of common carotid artery corrected Flow Time (cFT) change during Passive Leg Raising (PLR) in predicting Post Induction Hypotension (PIH). measure: Thresholds of common carotid artery corrected Flow Time (cFT) change after Passive Leg Raising(PLR) in predicting Post Induction Hypotension (PIH). measure: Time required to get common carotid artery corrected Flow Time(cFT) data. measure: Common carotid artery corrected Flow Time (cFT) during induction correlation with Post Induction Hypotension(PIH). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mount Sinai Hospital city: Toronto state: Ontario zip: M5G 1X5 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06316804 id: 2022P000580 id: 1K23MH128535-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1K23MH128535-01A1 briefTitle: Mobile Mental Health Stigma Reduction Intervention Among Black Adults overallStatus: RECRUITING date: 2024-03-15 date: 2026-07-31 date: 2027-07-31 date: 2024-03-18 date: 2024-04-12 name: Massachusetts General Hospital class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: Major depressive and anxiety disorders are highly prevalent in the general population and are a leading cause of disability. Black adults have a high burden of depression and anxiety. This study aims to assess a self- administered video-based intervention to reduce mental illness stigma and medical mistrust among Black adults with moderate to severe depression or anxiety. conditions: Anxiety conditions: Depression conditions: Health Knowledge, Attitudes, Practice conditions: Stigmatization conditions: Mobile Phone Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to one of three intervention arms. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE maskingDescription: Random assignment to the 3 arms in a 1:1:1 allocation ratio will be determined centrally by the PI according to a random schedule. There is no practical way to blind the study participants to treatment and accomplish the objectives of the study. However, the study participants will be unaware of the aims of the arm to which they were assigned. Because they will not be blinded to the video exposure, the study participants assigned to one of the video contact arms will be aware that they are being exposed to a video-based contact intervention, and the study participants assigned to the waitlist control arm will be aware that they are being waitlisted. The research coordinator/team member (who will be conducting the outcome assessments) will be blinded to treatment assignment status. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Video Intervention 1 name: Video Intervention 2 name: Video Intervention 3 measure: Treatment Inventory of Costs in Patients with Psychiatric Disorders measure: Release of Information Form measure: Reported and Intended Behavior Scale measure: Internalized Stigma of Mental Illness measure: The Group Based Medical Mistrust Scale measure: Group Help Seeking Questionnaire sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Massachusetts General Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Aderonke Bamgbose Pederson, MD role: CONTACT phone: 617-724-4587 email: apederson@mgh.harvard.edu lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06316791 id: HY001007 briefTitle: Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases overallStatus: RECRUITING date: 2021-12-14 date: 2024-12-13 date: 2025-12-13 date: 2024-03-18 date: 2024-03-18 name: Juventas Cell Therapy Ltd. class: INDUSTRY briefSummary: Exploratory clinical study of CNCT19 anti CD19 cell therapy in the treatment of refractory autoimmune diseases,To evaluate the safety and tolerability of CNCT19 in patients with refractory systemic lupus erythematosus (lupus nephritis, immune thrombocytopenia), refractory ANCA-associated vasculitis, and refractory dermatomyositis on the basis of standard of care. conditions: Lupus Erythematosus, Systemic studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: single dose of CNCT19 measure: Percentage of Subjects Experiencing Treatment-Emergent Adverse Events（TEAE） measure: Overall survival (OS) measure: SELENA-SLEDAI measure: The proportion of subjects who achieved glucocorticoids/immunosuppressant free and subjects who achieved low-dose glucocorticoids application during the main study period measure: To evaluate disease related biomarkers measure: To evaluate disease related biomarkers measure: To evaluate disease related biomarkers measure: To evaluate disease related biomarkers sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Zhengzhou University status: RECRUITING city: Zhengzhou state: Henan country: China name: Yi Zhang, Dr. role: CONTACT name: Shengyun Liu, Dr. role: CONTACT lat: 34.75778 lon: 113.64861 hasResults: False

 nctId: NCT06316778 id: 2023-038 briefTitle: Pelvic Floor Muscle Training for Women With Myotonic Dystrophy overallStatus: ENROLLING_BY_INVITATION date: 2024-03-11 date: 2024-12-01 date: 2024-12-01 date: 2024-03-18 date: 2024-03-28 name: Université de Sherbrooke class: OTHER name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke name: Interdisciplinary research team on neuromuscular diseases (GRIMN) name: CIUSSS Saguenay-Lac-Saint-Jean briefSummary: Myotonic dystrophy type 1 (DM1) is a neuromuscular disease characterized by multisystem manifestations. DM1 can affect the urinary system through the impact of the pelvic floor muscles (PFM). Urinary incontinence can occur in this situation and is often offset with compensatory measures without restoring the PFM function (e.g. sanitary pads). PFM training have already been shown to be effective in reducing or even eliminating urinary incontinence in the general population. However, no study has been the subject of this modality in people with DM1. Having recently shown that it is possible to gain strength with DM1, a strengthening protocol targeting PFM could prove effective in treating urinary incontinence. The objectives of this study are i) to assess the feasibility and acceptability of PFM training and ii) to investigate the effects of PFM training in women with DM1 with adult phenotype. A quasi-experimental study will be conducted with 12 women having a confirmed diagnosis of DM1 with urinary incontinence. Participants will follow a 12-week PFM training program, comprising weekly sessions with an experienced physiotherapist as well as a home exercise program. Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, frequency of urinary incontinence, urogynecological symptoms and their impact on quality of life, morphometry and function of PFM, and the perceived improvement following the treatments. This study has the potential to improve the management of urinary incontinence and support the implementation of pelvic floor rehabilitation services in this population. conditions: Myotonic Dystrophy Type 1 conditions: Urinary Incontinence studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: pre-treatment assessment - intervention (12 weeks) - post-treatment assessment primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Pelvic floor muscle training measure: Percentage of attended treatment sessions measure: Percentage of home exercises performed measure: Retention rate measure: Recruitment rate measure: Intervention Acceptability Questionnaire measure: Change in the frequency of urinary incontinence episodes measure: Change in urinary incontinence symptoms measure: Change in pelvic floor disorder symptoms measure: Change in pelvic floor disorder symptoms related impact on quality of life measure: Change in pelvic floor muscles morphometry measure: Change in pelvic floor muscles function measure: Patient's satisfaction measure: Patient's global impression of change measure: Patient's estimated improvement sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique des maladies neuromusculaires city: Jonquière state: Quebec zip: G7X 7X2 country: Canada lat: 48.41648 lon: -71.24884 hasResults: False

 nctId: NCT06316765 id: 118/10 briefTitle: A Stylet Use May be Beneficial for Elective and Rescue Intubation of Prematurely Born Infants overallStatus: COMPLETED date: 2016-01-01 date: 2022-12-31 date: 2022-12-31 date: 2024-03-18 date: 2024-03-19 name: Charles University, Czech Republic class: OTHER briefSummary: Contrary to recent findings suggesting that stylets offer no advantage in general infant intubations, this study focuses on their potential benefits for premature infants undergoing elective or rescue intubation in the delivery room. The goal is to compare the safety and efficiency of intubations with or without a stylet. conditions: Neonatology studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 70 type: ACTUAL name: Intubation with stylet measure: The primary outcome was defined as successful initial intubation attempt. measure: Secondary outcomes was defined as the duration of intubation courses until successful placement of the endotracheal tube. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06316752 id: 202107158RINB briefTitle: The Natural History of Sialidosis Type I overallStatus: RECRUITING date: 2022-03-15 date: 2024-03-16 date: 2024-12-31 date: 2024-03-18 date: 2024-03-19 name: National Taiwan University Hospital class: OTHER briefSummary: Sialidosis type 1 is an autosomal recessive disorder caused by bialleic NEU1 gene mutations. Patients with sialidosis type I present variable neurological and eye dysfunction and the progression rate is variable. The goal of this protocol is to assess the neurological and ophthalmological status of these patients and characterize the clinical and laboratory abnormalities in order to determine the natural history of the disease. Patients will be followed every 6 month with comprehensive clinical, neurological and ophthalmological examinations combined with neuropsychological, blood, radiological and electrophysiological tests. conditions: Observational Study studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Observational study measure: Scale for the Assessment and Rating of Ataxia (SARA) measure: Unified Myoclonus Rating Scale (UMRS) measure: MRI of the brain measure: Blood test for alpha-N -acetyl neuraminidase activity and neruofilamment light chain measure: Electrophysyiology test on peripheral nerves measure: Opathalmology examinations for cherry-red spots measure: Montreal cognitive assessment score sex: ALL minimumAge: 12 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital status: RECRUITING city: Taipei zip: 100 country: Taiwan name: Chin-Hsien Lin, MD, PhD role: CONTACT phone: 882-23123456 email: chlin@ntu.edu.tw name: Wuh-Liang Hwu, MD, PhD role: CONTACT lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06316739 id: R34DA057166 type: NIH link: https://reporter.nih.gov/quickSearch/R34DA057166 briefTitle: The Ganchero Intervention for Migrant People Who Inject Drugs From Puerto Rico in New York City overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-11 date: 2025-11 date: 2024-03-18 date: 2024-03-18 name: North Jersey AIDS Alliance dba North Jersey Community Research Initiative (NJCRI) class: OTHER name: City University of New York, School of Public Health briefSummary: The goal of this pilot clinical trial is to learn if an intervention that trains Gancheros (people who provide injection services in exchange for drugs or money) to conduct risk-reduction outreach could help lower risk for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and overdose among migrant Puerto Rican people who inject drugs (PWID) in New York City. The main questions it aims to answer are:

* Can the Ganchero intervention be carried out successfully and will Gancheros and their clients like it?
* Could the Ganchero intervention help Puerto Rican PWID who are clients of Gancheros use sterile syringes and carry naloxone (a medication to reverse opioid overdoses) more often?

Gancheros who participate in the trial will be asked to attend a 6-session training on HIV, HCV, and overdose prevention and then to share key prevention messages and supplies (e.g., naloxone, sterile syringes and other injection equipment) with their clients during 4 months of outreach. The intervention will be carried out with Gancheros and their clients in two Bronx neighborhoods, one after the other, so the investigators can see if clients in the neighborhood that received the intervention first have better outcomes than clients in the neighborhood that did not yet receive the intervention. conditions: HIV Infections conditions: HCV conditions: Overdose studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Non-randomized wait-list controlled trial. The intervention will be implemented in 2 neighborhoods (in the Bronx, New York City) sequentially. Outcomes among participants in the immediate intervention neighborhood will be compared to outcomes among participants in the delayed intervention neighborhood. primaryPurpose: PREVENTION masking: NONE count: 70 type: ESTIMATED name: Ganchero intervention measure: sterile syringe use measure: naloxone carriage measure: Feasibility of intervention - Ganchero Engagement measure: Feasibility of intervention - Client Engagement measure: Acceptability of the intervention's training component to Gancheros measure: Acceptability of the intervention's outreach component to Gancheros measure: Acceptability of intervention to Clients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06316726 id: 202100409A3 briefTitle: The Effectiveness of Two Nursing Programs on the Surgery-related Pressure Injury overallStatus: COMPLETED date: 2021-12-15 date: 2023-08-31 date: 2023-08-31 date: 2024-03-18 date: 2024-03-18 name: Chang Gung Memorial Hospital class: OTHER briefSummary: Introduction: This study was to compare the differences in the incidence, grade, and time of surgery-related pressure injuries between the two interventions; and describe the locations of surgery-related pressure injuries between the two interventions.

Methods: This study adopted a true experimental research design with a convenience sampling method from the operating rooms of a teaching hospital in a northern region. The experimental group was randomly assigned by block to receive intervention A (full bed silicone mattress plus other measures), and the control group received intervention B (full bed silicone mattress plus usual care). Measurements include basic personal attributes, risk factors, grade, time, and location of occurrence related to surgery-related pressure injuries. conditions: Pressure Injury conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The experimental group was randomly assigned by block to receive intervention A (full bed silicone mattress plus other measures), and the control group received intervention B (full bed silicone mattress plus usual care). primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 461 type: ACTUAL name: full bed silicone mattress plus other measures measure: the occurrence of surgery-related pressure injuries sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taoyuan Chang Gung Memorial Hospital city: Taoyuan zip: 333 country: Taiwan lat: 24.95233 lon: 121.20193 hasResults: False

 nctId: NCT06316713 id: IRB_00166637 briefTitle: One MORE for Chronic Pain in Latinos overallStatus: RECRUITING date: 2024-04-08 date: 2024-12-31 date: 2024-12-31 date: 2024-03-18 date: 2024-04-17 name: University of Utah class: OTHER briefSummary: This study will be a single-site, two-arm randomized controlled trial conducted among Spanish-speaking chronic pain patients. Chronic pain patients will be randomized by a computer-generated randomization schedule with simple random allocation (1:1) to either One MORE or a wait-list control condition (WLC). One MORE will be delivered individually either in-person or via a HIPAA compliant virtual meeting platform. conditions: Chronic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 34 type: ESTIMATED name: One MORE (Spanish Adaptation) measure: Pain Intensity & Interference measure: Acute Pain measure: Acceptability measure: Pain Catastrophizing measure: Well-Being measure: Depression measure: Anxiety measure: Mindful Reappraisal of Pain Sensations measure: Trait Self-Transcendence measure: Decentering measure: State Self-Transcendence measure: State Anxiety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Utah status: RECRUITING city: Salt Lake City state: Utah zip: 84112 country: United States name: Eric Garland, PhD role: CONTACT phone: 801-581-3826 email: eric.garland@socwk.utah.edu lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06316700 id: AG-02-0124 briefTitle: A Pharmacokinetic Study of a Novel Nutritional Product on Healthy Men and Women overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-07-31 date: 2024-10-01 date: 2024-03-18 date: 2024-03-18 name: Athletic Greens International class: INDUSTRY briefSummary: This study is a randomized, double-blind, placebo-controlled study of N=16 apparently healthy men and women. The purpose of this study is to examine the bioavailability of a health and wellness supplement. conditions: Healthy Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 16 type: ESTIMATED name: Nutritional supplement name: Placebo measure: Plasma concentration of zinc following consumption of study products measure: Plasma concentration of Vitamin C following consumption of study products measure: Plasma concentration of Folate following consumption of study products measure: Plasma concentration of calcium following consumption of study products sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Center for Applied Health Sciences city: Canfield state: Ohio zip: 44046 country: United States lat: 41.02506 lon: -80.76091 hasResults: False

 nctId: NCT06316687 id: prevalence of dental caries briefTitle: Prevalence of Dental Caries in a Group of Egyptian Children overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-09-01 date: 2024-12-01 date: 2024-03-18 date: 2024-03-18 name: Cairo University class: OTHER briefSummary: Prevalence of Dental Caries in a group of Egyptian children and its relation to TV and other screens time and sugar consumption (Observational cross-sectional study) conditions: Prevalence of Dental Caries and Its Relation to Screen Time and Sugar Consumption conditions: Prevalence,Patient studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 296 type: ESTIMATED name: questionnaire for food consumption frequency measure: Prevalence of dental caries measure: Dental neglect Dental neglect Dental neglect measure: Screen time evaluation measure: A sugar consumption evaluation sex: ALL minimumAge: 6 Years maximumAge: 8 Years stdAges: CHILD facility: Cairo University city: Cairo state: Al Manial country: Egypt name: rasha ad el, phd role: CONTACT phone: 00201111511145 lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06316674 id: 03C304 briefTitle: The Malleability of Body Representation in Anorexia Nervosa: the Sixth Finger Illusion acronym: SESTODITO_AN overallStatus: RECRUITING date: 2023-05-01 date: 2024-04-30 date: 2024-04-30 date: 2024-03-18 date: 2024-03-27 name: Istituto Auxologico Italiano class: OTHER name: Heriot-Watt University name: Birkbeck, University of London name: Catholic University of the Sacred Heart briefSummary: Body representation can be explored using behavioural tasks such as motor imagery tasks as well as body illusions.

In both cases, evidence from studies on healthy individuals as well as patients with lesions to the central nervous system show that body representation is not set in stone: how we imagine our bodies is a dynamic and continuously updated process, to reflect changes in our own body as well as the environment.

In anorexia nervosa the representation of the body is very different from that of healthy individuals: the representation is more malleable, and easier to manipulate, while at the same time being more detached from physical constraints. These features of body representation in anorexia nervosa might contribute to the persistence of symptoms and to relapses too. Body representation has clear implications for treatment of anorexia nervosa too.

The study aims at evaluating the presence of differences in the malleability of the body representation, explored through the illusion of the sixth finger, between a group of people with AN and a group of normal weight people, taking into account the biomechanical constraints that characterize the physical and mentally represented body. conditions: Anorexia Nervosa studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED name: sixth finger illusion measure: Sixth finger illusion questionnaire sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Istituto Auxologico italiano IRCSS status: RECRUITING city: Milan country: Italy name: Federico Brusa, Ph.D role: CONTACT email: f.brusa@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06316661 id: 09C921 briefTitle: CMR Assessment of Cardiac Microvascular Dysfunction in Patients With HFpEF acronym: MAPPED overallStatus: RECRUITING date: 2019-03-01 date: 2024-12-30 date: 2024-12-30 date: 2024-03-18 date: 2024-03-18 name: Istituto Auxologico Italiano class: OTHER briefSummary: Heart failure with preserved ejection fraction (HFpEF) causes hospitalizations, premature mortality and high health care costs. This is also due to poor understanding of HFpEF pathogenesis and, thus, lack of specific therapies. Prompted by the recent demonstration that HFpEF clusters different clinical phenotypes, the investigators propose that these phenogroups are driven by distinct myocardial abnormalities. Cardiac Magnetic Resonance (CMR) can help filling this gap in knowledge: on top of providing gold standard measurements for myocardial volume and cellular mass, recent technical advantages mean that this test can assess and quantify left ventricular extracellular volume, fibrosis and microvascular function accurately and non-invasively. In HFpEF patients, the investigators aim at assessing 1) the coronary microvascular function impairment; 2) the myocardial fibrotic burden; - seeking to understand the disease in order to improve care and cardiovascular outcomes for these patients. conditions: Microvascular Coronary Artery Disease conditions: Heart Failure With Reduced Ejection Fraction studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED name: stress perfusion cardiac magnetic resonance name: cardiopulmonary exercise test measure: Peak stress perfusion measure: Extracellular volume sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Auxologico Italiano status: RECRUITING city: Milan zip: 20149 country: Italy name: Camilla Torlasco role: CONTACT phone: +390261911 phoneExt: 2932 email: c.torlasco@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06316648 id: 210366 briefTitle: Whey Intake Blood Glucose, Fasting, Thirst, Nausea and Vomiting Levels of Patients Undergoing Elective Hip Fracture Surgery overallStatus: COMPLETED date: 2021-04-20 date: 2021-04-20 date: 2021-07-20 date: 2024-03-18 date: 2024-03-18 name: TC Erciyes University class: OTHER briefSummary: Whey Intake Blood Glucose, Fasting, Thirst, Nausea, Vomiting Elective Hip Fracture Surgery conditions: Elective Hip Fracture Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multidisciplinary cooperation was performed for the effective and efficient conduct of the study. In determining the patients to administer Whey according to the study's inclusion criteria, an orthopedic and traumatological specialist's support was received, as well as that of an anesthesiologist. On the other hand, the researcher cooperated with a nutritionist in preparing and assessing the Whey content to be administered to the patients. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ACTUAL name: whey intake group name: control group measure: blood glucose measure: Fasting, Thirst measure: Nausea and Vomiting sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erciyes University city: Kayseri̇ state: Talas zip: 38000 country: Turkey lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06316635 id: 2023/209 id: self-funding type: OTHER domain: Erciyes University briefTitle: Microplastics in Otitis Media With Effusion Material overallStatus: RECRUITING date: 2024-03-20 date: 2024-04-20 date: 2024-04-20 date: 2024-03-18 date: 2024-03-27 name: Kerem Kökoğlu class: OTHER briefSummary: Microplastic rate is increasing ib athmosphere. They can be found in lung, kidney, heart, even placenta. Otitis media with effusion (OME) is a clinical condition that is ver common in children. Biofilms are blamed in the pathogenesis of OME. Microplastics can include biofilms. Importance of microplastics for potential pathogens and their toxicity aspects should be enlighted with studies. This study aims to investigate presency of microplastics in middle ear fluid of patients with OME. conditions: Microplastics conditions: Otitis Media With Effusion conditions: Biofilms studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: ventilation tube insertion measure: Microplastic presence sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Erciyes University Medical School status: RECRUITING city: Kayseri zip: 38039 country: Turkey name: KEREM KÖKOĞLU role: CONTACT phone: 535-205-6780 email: dr.kokoglu@gmail.com name: Onat B Taş, M.D. role: CONTACT phone: 90 505-702-2227 email: onat-berkay@hotmail.com name: Mehmet I Şahin, Assoc. Prof, M.D. role: SUB_INVESTIGATOR lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06316622 id: 2021/08/42 briefTitle: Examination of The Relationshıp Between Body Mass Index And The Skin-Epidural Space Distance overallStatus: COMPLETED date: 2021-03-08 date: 2022-10-01 date: 2022-10-01 date: 2024-03-18 date: 2024-03-18 name: Dokuz Eylul University class: OTHER briefSummary: Aim: The aim of the study; to investigate whether there is a relationship between body mass index (BMI), waist circumference, and abdominal subcutaneous adipose tissue and the skin-epidural space distance measured by USG. conditions: Anesthesia Awareness studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: relationship between body mass index and the skin epidural space distance primaryPurpose: OTHER masking: NONE maskingDescription: relationship between body mass index and the skin epidural space distance count: 42 type: ACTUAL name: ultrasound measure: We examined the relationships between body mass index calculated by measuring weight and height, subcutaneous fat tissue in the abdominal region and the skin-epidural space distance in the lumbar region; measured by ultrasound. sex: ALL minimumAge: 21 Years maximumAge: 58 Years stdAges: ADULT facility: Dokuz Eylul Unicersity city: İzmir state: Narlidere zip: 35150 country: Turkey lat: 38.41273 lon: 27.13838 facility: Dokuz Eylul University city: İzmir country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06316609 id: AD2016-2027 briefTitle: Prenatal Exposure to Emerging Contaminants and Children's Atopic Dermatitis acronym: PECCAD overallStatus: ACTIVE_NOT_RECRUITING date: 2016-06 date: 2018-04-30 date: 2027-12-31 date: 2024-03-18 date: 2024-03-18 name: Children's Hospital of Fudan University class: OTHER name: Minhang Maternal and Children Health Care Hospital name: School of Public Health，Fudan University briefSummary: This prospective cohort study aims to investigate the association between prenatal blood levels of Emerging Contaminants and the five-year incidence of atopic dermatitis (AD) in offspring. conditions: Atopic Dermatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 456 type: ACTUAL name: Gestational Exposure to Emerging Contaminants (ECs) measure: atopic dermatitis: Infant atopic dermatitis incidence measure: atopic dermatitis measure: atopic dermatitis measure: atopic dermatitis measure: prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at early pregnancy measure: prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at mid pregnancy measure: prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at late pregnancy measure: prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at first trimester measure: prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at second trimester measure: prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at third trimester measure: Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) in Umbilical cord whole blood measure: Umbilical cord serum Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) measure: prenatal exposure to Organophosphate Flame Retardants (OPFRs) at early pregnancy measure: prenatal exposure to Organophosphate Flame Retardants (OPFRs) at mid pregnancy measure: prenatal exposure to Organophosphate Flame Retardants (OPFRs) at late pregnancy measure: prenatal exposure to Organophosphate Flame Retardants (OPFRs) at first trimester measure: prenatal exposure to Organophosphate Flame Retardants (OPFRs) at second trimester measure: prenatal exposure to Organophosphate Flame Retardants (OPFRs) at third trimester measure: Organophosphate Flame Retardants (OPFRs) in Umbilical cord whole blood measure: Umbilical cord serum Organophosphate Flame Retardants (OPFRs) measure: Infant skin barrier function (Transepidermal Water Loss, TEWL） measure: Infant skin barrier function (Transepidermal Water Loss, TEWL） measure: Infant skin barrier function (Transepidermal Water Loss, TEWL） measure: Infant skin barrier function (Stratum corneum hydration, SCH) measure: Infant skin barrier function (Stratum corneum hydration, SCH) measure: Infant skin barrier function (Stratum corneum hydration, SCH) measure: Infant skin barrier function (sebum content) measure: Infant skin barrier function (sebum content) measure: Infant skin barrier function (sebum content) measure: Infant skin barrier function (skin surface pH) measure: Infant skin barrier function (skin surface pH) measure: Infant skin barrier function (skin surface pH) measure: prenatal exposure to Microplastics at early pregnancy measure: prenatal exposure to Microplastics at mid pregnancy measure: prenatal exposure to Microplastics at late pregnancy measure: prenatal exposure to Microplastics at first trimester measure: prenatal exposure to Microplastics at second trimester measure: prenatal exposure to Microplastics at third trimester measure: Microplastics in Umbilical cord whole blood measure: Umbilical cord serum Microplastics measure: Allergic rhinitis measure: Asthma measure: Infantile hemangioma sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Children Hospital of Fudan University city: Shanghai state: Shanghai zip: 201102 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06316596 id: 2011-KAEK-25 2023/09-16 briefTitle: Brain Oxygenation in Newborns Due to Neuroaksial Methods acronym: oxygenation overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-01 date: 2024-05-01 date: 2024-03-18 date: 2024-03-18 name: Bursa Yüksek İhtisas Education and Research Hospital class: OTHER_GOV briefSummary: Epidural and spinal anesthesia techniques are frequently used all over the world in elective cesarean section operations. To evaluate the effects of epidural and spinal anesthesia techniques applied in cesarean section surgery on neonatal cerebral oxygenation using Near Infrared Spectroscopy (NIRS). conditions: Cesarean Section conditions: Pregnancy Related conditions: Cerebral Hypoxia conditions: Anesthesia, Regional conditions: Oxygen Saturation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The research is a prospective controlled,randomized,double-blind study primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The research is a prospective, randomized, single-blind, parallel group study. In the study, the Quincke needle will be used for spinal anesthesia and the Tuoghy needle will be used for epidural anesthesia. Oxygenation will be evaluated with the help of NIRS probe in the post-cesarean newborns of pregnant women who will undergo elective cesarean section.

Vitals will be monitored throughout the case with electrocardiography (ECG), non-invasive blood pressure monitoring and spO2. The amount of vasopressor agent and hydration required by the mother throughout the case will be recorded. While one anesthesiologist will monitor the anesthesia method and maternal vitals, the other anesthetist will monitor the NIRS monitoring attached to the newborn. whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Spinal Anesthesia name: Epidural Anesthesia measure: Near İnfrared Spectroscopi measure: Maternal mean arterial pressure measure: Newborn vitalty measure: Newborn vitalty sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06316583 id: BJH-001 briefTitle: Clinical Study on Dry Needling for Primary Dysmenorrhea and Its Preliminary Correlation With Acupoints overallStatus: RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2026-12-31 date: 2024-03-18 date: 2024-04-18 name: Beijing Hospital class: OTHER_GOV name: Beijing Municipal Health Commission briefSummary: Primary dysmenorrhea refers to menstrual pain not caused by pelvic organic lesions, commonly seen in young women, significantly affecting patients' quality of life. Dry needling therapy targeting myofascial trigger points for primary dysmenorrhea has been preliminarily applied in clinical settings. However, related research is limited with questionable quality, hindering its widespread clinical application. Furthermore, is there a connection between myofascial trigger points in dry needling and acupuncture acupoints in terms of selection and mechanism of action? Could this be a new interpretation of acupuncture theory? These are important questions that have garnered widespread attention. This study employs a randomized patient-blinded controlled design, enrolling primary dysmenorrhea patients aged 18 to 30 years. They are randomly divided into three groups: the trigger point dry needling group, traditional acupuncture treatment group, and trigger point sham needle (placebo) group. Changes in pain levels, quality of life scores, inflammatory factor levels, and local blood flow before and after treatment among the three groups are observed. The aim is to assess the therapeutic effects of dry needling trigger points and acupuncture treatments on primary dysmenorrhea and explore their potential mechanisms of action. By comparing the differences and similarities between dry needling trigger points and acupuncture treatments in terms of acupoint selection, treatment effects, and potential mechanisms of action, this study seeks to preliminarily explore the feasibility of integrating trigger point theory into the meridian 'acupoint' theory, laying the foundation for a modern interpretation of acupuncture conditions: Trigger Point Pain, Myofascial conditions: Acupuncture conditions: Primary Dysmenorrhea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Using a single-center randomized controlled patient-blind study design, 150 eligible participants are randomly assigned to three groups: a placebo group (sham trigger point needling), a dry-needling trigger points treatment (TrP-DN)group, and a traditional acupuncture group. Compared to the placebo group, this study assesses the effects of TrP-DN and traditional acupuncture on pain and quality of life for primary dysmenorrhea patients, as well as their long-term outcomes. Additionally, the study observes their impact on inflammatory factors and local uterine blood flow, aiming to explore the mechanisms underlying TrP-DN and traditional acupuncture treatments for PD. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: This experiment is a single-blind study where randomization occurs centrally through an online data management system after collecting baseline data from participants. A designated research coordinator manages the randomization process and facilitates communication among research personnel. Due to the nature of the intervention, operators are aware of the group assignments, but evaluators, unaware of these assignments, assess and collect baseline, post-treatment, and follow-up data. Since none of the participants have received any prior acupuncture or trigger point dry needling treatments, using a scalable sham needle on the same trigger points ensures blinding by simulating the effects of actual treatment. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: TrP-DN and Acupuncture measure: mean intensity of pain measure: mean intensity of painscale during period a 100mm horizontal line, with the ends of the line representing the extreme expressions of pain (no pain to maximum pain).The mean intensity of all days with menstrual pain is used for the analysis measure: Short Form Health Survey measure: Global Rating of Change Scale measure: the amount of NSAIDs used measure: the frenquecy of NSAIDs used measure: inflammatory factors measure: local uterine blood flow：Doppler Systolic/Diastolic (S/D) Ratio measure: local uterine blood flow：Pulsatility Index (PI) measure: local uterine blood flow：The Resistance Index (RI) measure: Number of Participants with adverse effects with treatment measure: Assessing Participants Expectations of Outcomes of Complementary and Alternative Medicine Treatments measure: Rate of same points used between dry-needling group and traditional acupuncture group sex: FEMALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Yanxia Sun status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Yanxia Sun role: CONTACT lat: 39.9075 lon: 116.39723 facility: Yanxia Sun status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: LiHua Yang role: CONTACT phone: 8616601298893 name: Yi Ren role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06316570 id: HX-A-2023044 id: SF 2024-2-2045 type: OTHER_GRANT domain: Capital health development research project briefTitle: Ticagrelor With Aspirin Dual Antiplatelet Therapy Combined With Intravenous Thrombolysis for Ischemic Stroke acronym: TAPIS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-01 date: 2026-12-01 date: 2024-03-18 date: 2024-03-19 name: Beijing Tiantan Hospital class: OTHER briefSummary: Early antiplatelet therapy is promising for further improvement of functional prognosis on the basis of intravenous thrombolytic therapy. The primary purpose of this multicenter, randomized, double-blind, placebo-parallel controlled trial is to evaluate the efficacy and safety of the early dual antiplatelet therapy (within 6 hours of onset ) of ticagrelor with aspirin combined with intravenous thrombolysis in improving good functional outcome (mRS score 0-1) at 90 days inpatients with ischemic stroke. conditions: Ischemic Stroke, Acute studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1380 type: ESTIMATED name: Early Dual Antiplatelet Therapy name: Placebo measure: Excellent functional outcome measure: mRS score of 0-2 points measure: Distribution of mRS score measure: Neurologic improvement measure: Quality of life (EQ-5D scale) measure: Activity of daily living (Barthel index ≥95 points) measure: Recurrent ischemic stroke measure: Symptomatic intracranial hemorrhage (ECASS-III) measure: Symptomatic intracranial hemorrhage (ECASS-III) measure: Parenchymal hematoma type 2 (SIST-MOST) measure: Parenchymal hematoma type 2 (SIST-MOST) measure: Bleeding events (GUSTO) measure: Adverse events measure: Severe adverse events sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06316557 id: HX-A-2022063 briefTitle: High-frequency rTMS on the Cerebellar to Improve Post-stroke Cognitive Impairment acronym: HOPE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-07-01 date: 2027-04-01 date: 2024-03-18 date: 2024-03-18 name: Beijing Tiantan Hospital class: OTHER briefSummary: The objective of this clinical trial is to investigate the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) in the cerebellum for individuals with post-stroke cognitive impairment. Participants will undergo rTMS in the cerebellar hemisphere opposite the lesion site, once daily for a total of five days. conditions: Post-stroke Cognitive Impairment conditions: Ischemic Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicenter Randomized Double-Blind Controlled Study primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: rTMS group name: control group measure: The efficacy of rTMS in improving cognitive function of post-stroke cognitive impairment measure: The safety of rTMS in improving cognitive function of post-stroke cognitive impairment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06316544 id: CECMed id: 2021ZD0111000 type: OTHER_GRANT domain: National Science and Technology Major Project briefTitle: China Elderly Comorbidity Medical Database acronym: CECMed overallStatus: RECRUITING date: 2023-03-01 date: 2024-11-30 date: 2024-11-30 date: 2024-03-18 date: 2024-03-19 name: Beijing Friendship Hospital class: OTHER name: Chinese Academy of Medical Sciences, Fuwai Hospital name: The First Affiliated Hospital of Zhengzhou University briefSummary: The objective of this observational cohort study is to provide comprehensive evaluation and early warning for elderly patients with chronic diseases. The main question it aims to answer is: How to explore effective evaluation methods for diseases in elderly patients based on the coexistence of multiple diseases and high individual heterogeneity? How to explore the key indicators and influencing factors of adverse events in elderly patients.. Participants will be followed up at 1, 3, 6, 9, and 12 months to obtain adverse event information. conditions: Coronary Artery Disease conditions: Hypertension conditions: Diabetes Mellitus conditions: Osteoporosis conditions: COPD Chronic Obstructive Pulmonary Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 4100 type: ESTIMATED measure: Pneumonia/pulmonary infection measure: respiratory failure measure: pulmonary encephalopathy measure: acute exacerbation of chronic obstructive pulmonary disease measure: unstable angina pectoris measure: acute myocardial infarction measure: acute hemorrhagic stroke measure: acute ischemic stroke measure: acute heart failure/acute exacerbation of chronic heart failure measure: malignant ventricular arrhythmia measure: sudden death measure: falls measure: fractures measure: gastrointestinal bleeding measure: pulmonary embolism measure: deep vein thrombosis measure: diabetes ketoacidosis measure: diabetes hyperosmolar coma measure: rehospitalization measure: admission to ICU sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Beijing Friendship Hospital status: RECRUITING city: Beijing state: Beijing zip: 100050 country: China name: Bingbing Ke, Dr role: CONTACT phone: 15510286857 email: 1017120710@qq.com name: Hongwei Li, Dr role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06316531 id: BL-M07D1-301 briefTitle: A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-05 date: 2026-05 date: 2024-03-18 date: 2024-03-19 name: Sichuan Baili Pharmaceutical Co., Ltd. class: INDUSTRY name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. briefSummary: This study is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally advanced or metastatic HER2-positive breast cancer who had failed previous treatment with taxanes and trastuzumab. conditions: HER2-positive Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 268 type: ESTIMATED name: BL-M07D1 name: T-DM1 measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Duration of Response (DOR) measure: Treatment Emergent Adverse Event (TEAE) measure: Anti-drug antibody (ADA) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University city: Guangzhou state: Guangdong country: China name: Erwei Song role: CONTACT name: Erwei Song role: PRINCIPAL_INVESTIGATOR name: Herui Yao role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06316518 id: AIBU-HF-YS-01 briefTitle: The Effect of Mindfulness-Based Web-Based Stress Reduction Program Applied to Primigravidas on Perceived Stress Level in Pregnancy, Birth Self-Efficacy and Prenatal Attachment overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-01 date: 2025-05-01 date: 2024-03-18 date: 2024-03-19 name: Ataturk University class: OTHER briefSummary: The aim of this study is to investigate the effect of a mindfulness-based web-based stress reduction program applied to primigravidas on perceived stress level in pregnancy, birth self-efficacy and prenatal attachment. conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups with a supportive care control groups primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 90 type: ESTIMATED name: mindfulness group measure: Pregnancy Stress Assessment Scale (PSAS) measure: Self-Efficacy Scale for Normal Childbirth measure: Prenatal Attachment Inventory (PAI) sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06316505 id: 11/2023-58 briefTitle: Oral Photographs of Patients on Oral Hygiene Motivation overallStatus: COMPLETED date: 2023-12-01 date: 2024-03-01 date: 2024-03-01 date: 2024-03-18 date: 2024-03-21 name: Didem OZKAL EMINOGLU class: OTHER briefSummary: Based on these considerations, this randomized controlled trial aimed to determine the effectiveness of a personalized visual oral health education program in addition to conventional education on oral hygiene by comparing changes in clinical periodontal parameters.

Participants will get conventional oral hygiene education (COHE) with/without visual motivation using self oral photographs of patients.

Researchers will compare Intervention group and control groups on oral hygiene by comparing changes in clinical periodontal parameters. conditions: Periodontal Diseases conditions: Motivation conditions: Hygiene studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 56 type: ACTUAL name: Oral hygiene motivation with individual oral photograps measure: Clinical periodontal parameters / plaque index (PI) measure: Clinical periodontal parameters / gingival index (GI) measure: Clinical periodontal parameters / probing pocket depth (PPD). measure: Clinical periodontal parameters / bleeding on probing (BOP) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Atatürk University city: Erzurum zip: 25240_ country: Turkey lat: 39.90861 lon: 41.27694 hasResults: False

 nctId: NCT06316492 id: 101919039932 briefTitle: A Study Done by a Demonstrator and Two Professors in Public Health and Community Medicine Department in Faculty of Medicine in Assiut and New Valley University to Assess Knowledge, Attitude ,and Practice of Rural Population in a Remote Governorate ( New Valley ) Towards Hepatitis B and C Viruses acronym: rural_remote overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2024-12-01 date: 2026-06-01 date: 2024-03-18 date: 2024-03-18 name: Assiut University class: OTHER briefSummary: This study is a research aiming to identify knowledge , attitude and practice of population in a village in a remote governorate towards viral hepatitis B and C . It involves home visit interviews with population in this village with the use of questionnaire involving questions asked by the researcher that would be orally answered by the participants to be recorded in papers by the researcher. conditions: Hepatitis B conditions: Hepatitis C studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 450 type: ESTIMATED measure: Assess proportion of adequate knowledge , attitude and practice /behaviour towards viral hepatitis B and C in a rural population in New Valley Governorate measure: Assess proportion of high risk groups of viral hepatitis B and C in these population thus behaviours made them candidates for viral hepatitis B and C infection measure: 2- Proportion of health-seeking behaviour of cases ( confirmation of diagnosis, treatment, and follow up ) and proportion of high risk group seeking for screening sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06316479 id: CI-001-23 briefTitle: Safety and Performance of PTMC Dermal Filler overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2024-12 date: 2025-12 date: 2024-03-18 date: 2024-03-18 name: Aqpha Medical B.V. class: INDUSTRY briefSummary: The goal of this clinical trial is to assess the safety and performance of the PTMC Dermal filler for treating moderate to severe nasolabial folds in adult men and women.

The main questions it aims to answer are:

* Does the PTMC dermal filler maintain its performance for a minimum of 6 months?
* Is the treatment considered safe for participants?

Participants will:

* Before treatment, the investigator will assess your medical history, medication usage, and satisfaction with your wrinkles/folds.
* You'll receive one injection of the PTMC Dermal filler during your initial visit.
* For 30 days post-injection, you'll keep a diary to note any reactions like pain, redness, or swelling at the injection site.
* At the 1-month follow-up, you can request a 'touch-up' of the filler, extending your participation in the study.
* Participants will visit the clinic a total of 8 times, including the initial treatment and 7 follow-up visits, spanning up to 18 months.
* Each visit will last approximately 60-90 minutes. The visits will be conducted in person. conditions: Moderate to Severe Nasolabial Fold studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: PTMC Dermal Filler measure: Nasolabial fold severity measure: Safety (Adverse events) measure: Nasolabial fold severity measure: Responder rate measure: Overall aesthetic improvement (by the investigator) measure: Overall aesthetic improvement (by the subject) measure: Subject satisfaction measure: Visual Analog Scale (VAS) for pain measure: Treatment satisfaction measure: Ease of use sex: ALL minimumAge: 18 Years maximumAge: 67 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06316466 id: QYFYWZLL28521 briefTitle: Lipoprotein a is an Independent Risk Factor for Overall Survival in Patients With Pancreatic Cancer: a Propensity Score Matching Analysis overallStatus: RECRUITING date: 2023-06-01 date: 2024-01-30 date: 2024-03-30 date: 2024-03-18 date: 2024-03-18 name: jingxue class: OTHER briefSummary: Background: This study aims to assess the prognostic significance of serum lipoprotein (a) \[Lp (a)\] levels on overall survival (OS) and progression free survival (PFS) in individuals diagnosed with pancreatic cancer through the utilization of propensity score matching (PSM).

Methods: A retrospective analysis was conducted on the clinicopathological data of 364 patients diagnosed with pancreatic cancer at the Affiliated Hospital of Qingdao University from January 2019 to December 2022. The cut-off value for Lp (a) was determined based on one-year survival rates after diagnosis. Patients were then categorized into the high and low Lp (a) groups. We applied PSM analysis to minimize selection bias. The study compared OS and PFS between two groups by Kaplan-Meier method and analyzed differences using the log-rank test. Additionally, univariate and multivariate Cox-regression analyses were performed to identify prognostic factors among patients. conditions: Pancreatic Carcinoma; Lipoprotein a; Overall Survival; Prognosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 360 type: ESTIMATED name: Lp(a) measure: OS measure: PFS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Hospital of Qingdao University status: RECRUITING city: Qingdao state: Shandong country: China name: Jinyue Liu role: CONTACT phone: 17854269227 email: liujinyue99@163.com lat: 36.06488 lon: 120.38042 hasResults: False

 nctId: NCT06316453 id: PARADISE-PK-09-03-2024 briefTitle: Prospective Assessment of Atherosclerotic Cardiovascular Disease (ASCVD) Risk overallStatus: RECRUITING date: 2024-01-01 date: 2024-10 date: 2024-12 date: 2024-03-18 date: 2024-03-29 name: Advanced Education & Research Center class: OTHER name: University of Karachi name: Pakistan Cardiac Society (Heart House) briefSummary: This study aims to conduct a 10-year follow-up to assess ASCVD risk in Pakistan among individuals aged 30 years and above without a known history of ASCVD. The focus will be on evaluating ASCVD risk over this specific 10-year timeframe. The study will also validate risk assessment scores for identifying high-risk individuals and examine the incidence rate of ASCVD events during long-term follow-up. conditions: Atherosclerotic Cardiovascular Diseases (ASCVD) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3513 type: ESTIMATED name: Evaluating ASCVD risk over 10 and 30 year and lifetime measure: 10-year ASCVD risk Categorization measure: 30-year ASCVD risk Categorization measure: Lifetime ASCVD risk evaluation measure: Genetic Risk Assessment of ApoB sex: ALL minimumAge: 30 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Advanced Education Institute and Research Center status: RECRUITING city: Karachi state: Sindh zip: 75270 country: Pakistan name: Shamoon Noushad role: CONTACT phone: 03333549258 lat: 24.8608 lon: 67.0104 hasResults: False

 nctId: NCT06316440 id: noise and postoperative pain briefTitle: Effect of Noise Isolation on the Incidence of Moderate to Severe Postoperative Pain overallStatus: RECRUITING date: 2024-03-12 date: 2024-12 date: 2024-12 date: 2024-03-18 date: 2024-03-28 name: The Second Affiliated Hospital of Chongqing Medical University class: OTHER name: The First Affiliated Hospital of Zhengzhou University name: Shapingba People's Hospital of Chongqing University name: Chongganng General Hospital name: Wuhan University name: Tongji Hospital briefSummary: To investigate the effect of noise isolation during general anesthesia on the incidence of moderate to severe postoperative pain in patients undergoing major abdominal surgery. The aim of this study was to determine whether noise isolation can reduce the Incidence of moderate to severe postoperative pain and analgesic use. conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients were randomly divided into intervention group（noise blocking） and control group（No noise blocking） primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 304 type: ESTIMATED name: Wear noise-cancelling earphones measure: The incidence of moderate to severe postoperative pain measure: Patient controlled analgesia pump analgesic consumption measure: Patient controlled analgesia pump analgesic consumption measure: The incidence of additional analgesic requirements measure: Maximum pain score (NRS score) at 0-48 hours postoperatively measure: The incidence of moderate to severe postoperative pain measure: Accumulative postoperative pain NRS measure: Pain score (NRS score) at 0-6 hours postoperatively measure: Pain score (NRS score) at 6-12 hours postoperatively measure: Pain score (NRS score) at 12-24 hours postoperatively measure: Pain score (NRS score) at 24-48 hours postoperatively sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400010 country: China name: Guangyou Duan, MD role: CONTACT phone: (+86)18323376014 email: duangy@hospital.cqmu.edu.cn lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06316427 id: BJGBYY-IIT-LCYJ-2024-003 briefTitle: Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Acute Lymphoblastic Leukemia/Lymphoma overallStatus: RECRUITING date: 2024-03-22 date: 2026-04-01 date: 2028-03-30 date: 2024-03-18 date: 2024-03-25 name: Beijing GoBroad Hospital class: OTHER briefSummary: This is a single-center, open-label, non-randomized, phase I/II trial. Patients with refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) will receive autologous, prior-HSCT donor-derived or new donor-derived CD7 CAR T cells according to their HSCT history, peripheral blood leukemia burden and at their discretion. The primary objective is to learn about the safety of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase I and to learn about the efficacy of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase II. The primary endpoint is type and incidence of dose limiting toxicity (DLT) within 21 days after CD7 CAR T-cell infusion in phase I and overall response rate (ORR), which includes CR, CRh, CRi, MLFS, aplastic marrow for blood and bone marrow; central nervous system (CNS) remission; CR and PR for lymphomatous extramedullary disease according to National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia at 3 months (± 1 week) post CD7 CAR T-cell infusion in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells in phase II. A total number of 80 subjects will be enrolled. conditions: T-cell Acute Lymphoblastic Leukemia conditions: Acute Lymphoblastic Leukemia, in Relapse conditions: Refractory Acute Lymphoblastic Leukemia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Investigator Initiate Trial primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Autologous CD7 CAR T-cell name: Prior-HSCT donor-derived CD7 CAR T-cell name: New donor-derived CD7 CAR T-cell measure: Dose-Limiting Toxicity (DLT) in phase I measure: Overall Response Rate (ORR) in phase II measure: Overall Response Rate (ORR) in phase I measure: Safety in phase II measure: Progression-Free Survival (PFS) in phase II measure: Duration of Remission (DOR) in phase II measure: Overall Survival (OS) in phase II measure: Levels of CD7 CAR-T Cells in phase II measure: Levels of CAR transgene in phase II measure: Levels of immune cells in phase II measure: Levels of cytokines in phase II sex: ALL minimumAge: 1 Year maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing GoBroad Hospital status: RECRUITING city: Beijing state: Beijing zip: 102206 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06316414 id: 1501/17 briefTitle: Omalizumab in Severe Asthmatics With Food Allergy acronym: OSAFA overallStatus: COMPLETED date: 2018-01-01 date: 2023-03-31 date: 2023-03-31 date: 2024-03-18 date: 2024-03-18 name: Bambino Gesù Hospital and Research Institute class: OTHER briefSummary: A prospective assessment of the impact of Omalizumab in terms of efficacy, safety, and quality of life (FA-QoL) in patients with moderate/severe asthma and history of anaphylaxis to peanut, tree nuts, fish, egg, milk, and/or wheat. Evaluation of the trend of total and specific IgE during Omalizumab treatment. conditions: Food; Allergy, Anaphylactic Shock conditions: Asthma in Children studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 65 type: ACTUAL name: Omalizumab measure: Milligram tolerated food allergen (gms) of raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T1. measure: Proportion of negative OFCs at T1 measure: NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T2. measure: NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T3. measure: Change in number of anaphylactic events measure: Rate of severity of anaphylactic events measure: Asthma Control Test (ACT) measure: Quality of Life score measure: Total IgE measure: Specific IgE for milk, egg, hazelnut, peanut, wheat, and/or fish sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Pediatric Hospital Bambino Gesù IRCCS - Allergy Dpt city: Roma zip: 00145 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06316401 id: 03-2024 briefTitle: Endoscopic Submucosal Dissection of Large Recto-sigmoid Lesions Under Spinal Anesthesia overallStatus: COMPLETED date: 2021-01-01 date: 2023-01-31 date: 2024-03-03 date: 2024-03-18 date: 2024-03-18 name: Azienda USL Modena class: OTHER briefSummary: The investigators collected data on all consecutive patients who underwent ESD for recto-sigmoid laterally spreading tumors (LSTs) \>35 mm under SA between January 2021 and March 2024. The investigators evaluated the technical success and safety of SA in terms of ARAEs, and pain, measured via visual assessment scale (VAS). conditions: Colorectal (Colon or Rectal) Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 20 type: ACTUAL name: ESD of large LSTs under SA measure: Technical success of ESD under SA measure: Safety of ESD under SA measure: Intra- and post-procedural need for additional opioid or other analgesic drug administration measure: ESD- and colonoscopy-related AEs measure: Length of hospital stay measure: Median ESD duration sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mauro Manno city: Carpi state: MO zip: 41012 country: Italy lat: 44.78237 lon: 10.8777 hasResults: False

 nctId: NCT06316388 id: TDME briefTitle: Outcomes After Vitrectomy in Eyes With Tractional Diabetic Macular Edema overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2025-03-10 date: 2025-03-11 date: 2024-03-18 date: 2024-03-18 name: Rehab Azzam class: OTHER briefSummary: 1. assessment the outcomes of vitrectomy on retinal function by mf-ERG (multifocal electroretinogram) and anatomy by OCT (optical coherence tomography) in patients with tractional diabetic macular edema (TDME) .
2. To correlate the postoperative corrected distance visual acuity (CDVA) with the mf-ERG and OCT findings following vitrectomy surgery for TDME. conditions: Diabetic Macular Edema studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 21 type: ESTIMATED name: vitrectomy measure: assessment the outcomes of vitrectomy on retinal function in patients with tractional diabetic macular edema measure: assessment the outcomes of vitrectomy on retinal anatomy in patients with tractional diabetic macular edema measure: correlation CDVA with mf-ERG and OCT finding sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06316375 id: STUMBL blunt chest trauma briefTitle: STUMBL Score as a Risk Stratification Tool for Management of Blunt Chest Trauma Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-31 date: 2026-04-30 date: 2024-03-18 date: 2024-03-27 name: Assiut University class: OTHER briefSummary: The aim of this study is to assess validity of the STUMBL score in EGYPT for complications of blunt chest trauma without multi-trauma and immediate life-threatening injuries and identify patients at risk of in- hospital mortality or ICU admission and predict survival in both Assiut \& Suez Canal University Hospitals. conditions: Blunt Injury of Thorax studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: The primary outcome was to assess the validity of the STUMBL score for all complications of chest blunt trauma, originally defined by the STUMBL authors measure: Secondary outcomes validated the STUMBL score using a composite of early and delayed complications. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06316362 id: SMOF in carbamazepine toxicity briefTitle: Efficacy of SMOF Lipid in the Management of Acute Poisoning With Carbamazepine overallStatus: COMPLETED date: 2022-01-01 date: 2023-02-01 date: 2023-02-28 date: 2024-03-18 date: 2024-03-18 name: Alexandria University class: OTHER briefSummary: The goal of the current study was to evaluate whether SMOF lipid administration could be used as an adjuvant therapy to treat acute, moderate-to-severe carbamazepine poisoning. conditions: Acute Poisoning studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ACTUAL name: SMOF lipid 20% measure: Improvement in Conscious Levels Measured by Glasgow Coma Scale (GCS) measure: Assessment of Intubation Requirement Using GCS and APACHE measure: Length of Intensive Care Unit (ICU) Stay measure: length of hospital stay sex: ALL minimumAge: 18 Years maximumAge: 54 Years stdAges: ADULT facility: Faculty of Medicine city: Alexandria country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False

 nctId: NCT06316349 id: CAAE: 75727323.3.0000.0068 briefTitle: Isolated Resistance Training and Neuromuscular Electrical Stimulation in Patients With Femoral Intra Aortic Balloon Pump. overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2025-01-10 date: 2025-10-01 date: 2024-03-18 date: 2024-03-19 name: University of Sao Paulo General Hospital class: OTHER briefSummary: The objective of this randomized clinical trial is to compare the effects of a standardized exercise program alone versus the same program combined with neuromuscular electrical stimulation in patients undergoing heart failure . The main questions it aims to answer are:

* Assessing the ultrasonographic parameters: echo intensity (echogenicity), cross-sectional area, thickness, and pennation angle of the rectus femoris muscle in both lower limbs.
* Evaluating the strength of the femoral quadriceps muscle
* Evaluating the changes in the chronaxie of the rectus femoris muscle in both lower limbs The protocol will have a total duration of 35 days, with an initial intervention period of 21 days (5 days per week), followed by a 14-day follow-up period. conditions: Heart Failure conditions: Physical Therapy conditions: Neuromuscular Electrical Stimulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Rondomized controlled trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The researcher responsible for conducting the ultrasonographic measurements will be blinded regarding the randomization and allocation groups. whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Isolated Resistance Training Program name: Neuromuscular electrical stimulation measure: To investigate echo intensity of the rectus femoris muscle measure: To investigate cross-sectional area of the rectus femoris muscle measure: To investigate pennation angle of the rectus femoris muscle measure: To investigate changes in quadriceps femoral muscle strength measure: To investigate changes in arterial blood pressure during the protocol measure: To investigate changes in heart rate during the protocol measure: To investigate changes in peripheral oxygen saturation during the protocol measure: To investigate changes in the veno-arterial difference in carbon dioxide partial pressure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo city: Sao Paulo zip: 05403-000 country: Brazil name: Silvia HG Lage, MD,PhD role: SUB_INVESTIGATOR name: Kelly CO Abud, PT,PhD role: SUB_INVESTIGATOR lat: -23.5475 lon: -46.63611 hasResults: False

 nctId: NCT06316336 id: BE24-005 briefTitle: Multiple Dose, Bioequivalence Study of Generic Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets Under Fed Conditions acronym: BE24-005 overallStatus: NOT_YET_RECRUITING date: 2024-06-10 date: 2024-06-22 date: 2024-06-28 date: 2024-03-18 date: 2024-03-18 name: Pharma Nueva class: INDUSTRY briefSummary: Objectives:

To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose after multiple oral dose administration in healthy subjects under fed conditions and To evaluate safety of test and reference formulations

Study Design:

An open label, randomized, two-treatment, two-period, two-sequence, multiple oral dose, crossover bioequivalence study in healthy Thai male volunteers under fed conditions with at least 7 days washout period between last dosing of Period 1 and first dosing of Period 2. conditions: Healthy Vollunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 44 type: ESTIMATED name: Alfuzosin Hydrochloride 10 mg name: Xatral® XL 10 mg measure: Plasma area Under the Curve (AUC(Day 6 and Day 7)) for Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets measure: Peak Plasma Concentration (Cmax) of Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06316323 id: REC/09/2021 (FB/51) briefTitle: The Anticariogenic Effect of Silver Diamine Fluoride and Sodium Fluoride Varnish overallStatus: COMPLETED date: 2023-02-01 date: 2023-09-29 date: 2024-01-26 date: 2024-03-18 date: 2024-03-18 name: Universiti Teknologi Mara class: OTHER briefSummary: Sodium Fluoride (NAF) varnish was considered as the treatment of Early Childhood Caries (ECC). However, the emergence of Silver Diamine Fluoride (SDF) has become more popular to tackle dental caries among children. SDF has silver ions that harbor antibacterial properties that play a crucial role in arresting active, cavitated carious lesions and has fluoride ions that are important in remineralizing enamel and dentin. This randomized control trial aims to compare the effect of SDF and NaF varnish on the salivary pH and density of Streptococcus mutans and Lactobacillus. 49 subjects below 6 years old, attending dental treatment at the Faculty of Dentistry, Universiti Teknologi MARA (UiTM) were recruited and were divided into two groups of treatment: 38% SDF or 5% SDF. Saliva samples of each subject were collected to test for salivary pH and density of S. mutans and Lactobacillus before the treatment and after 3 months of treatment. The salivary pH were tested using a calibrated pH meter. Saliva samples were subjected to microbiological analysis using Colony Forming Unit (CFU) and quantitative Polymerase Chain Reaction (qPCR) technique. The findings of this study will be used to support the use of SDF as an alternative to NaF varnish and to develop a recommendation guideline on the clinical use of SDF in ECC management. conditions: Early Childhood Caries studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: one group received silver diamine fluoride treatment, and another group received sodium fluoride varnish treatment primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Subjects that participated in this study were randomly allocated to two groups; Group A and Group B. Group A subjects were treated with 38% SDF and Group B subjects were treated with 5% NaF varnish. The randomisations of the subjects were done using a sealed envelope. Sequentially numbered, opaque sealed envelopes (SNOSE) method was used for the allocation concealments. This study was conducted in a non-blinded manner, as it was deemed impossible to blind the subjects. The treatment solutions utilized in this study were clearly distinct, with the SDF solution comprising a two-step process, while NaF varnish only required a single step. Additionally, the treatments exhibited different colors and textures. Consequently, the principal investigator had to closely supervise the treatment of each group. Due to the risk of blackish staining associated with SDF, parents and children were not blinded and were informed of the treatment they would receive. whoMasked: OUTCOMES_ASSESSOR count: 49 type: ACTUAL name: Silver diamine fluoride name: Sodium fluoride measure: comparison of salivary pH measure: comparison of salivary counts of Streptococcus mutans measure: comparison of salivary counts of Lactobacillus measure: Detection and comparison of salivary counts of Lactobacillus acidophilus sex: ALL minimumAge: 4 Years maximumAge: 6 Years stdAges: CHILD facility: University Technology MARA city: Sungai Buloh state: Selangor zip: 47000 country: Malaysia lat: 3.2 lon: 101.58333 hasResults: False

 nctId: NCT06316310 id: XSF20240312 briefTitle: Effect of Acupoint Thread Embedding on Obesity overallStatus: RECRUITING date: 2024-03-15 date: 2025-12-31 date: 2026-12-31 date: 2024-03-18 date: 2024-03-19 name: Shanghai Municipal Hospital of Traditional Chinese Medicine class: OTHER briefSummary: The investigators describe a protocol for a randomized controlled trial to find out the effect and safety of acupoint thread embedding on losing weight in obese patients. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: All eligible participants will be randomly assigned into two group at a ratio of 1:1, the Acupoint Thread Embedding group and the Sham Acupoint Thread Embedding group (the control group).

group). primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: acupoint thread embedding measure: Body Mass Index (BMI) measure: Change in body weight measure: Changes in body circumference measure: Body composition analysis measure: Abdominal visceral fat tissue thickness measure: Fasting blood glucose (FPG) measure: Blood lipid profile measure: Impact of Weight on Quality-of-Life Scale (IWQOL-Lite) measure: Well-Being Index (WHO-5) measure: Visual analog scale (VAS) of appetite measure: Hamilton Anxiety Scale (HAMA) measure: Adverse effects sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Shanghai Municipal Hospital of Traditional Chinese Medicine status: RECRUITING city: Shanghai state: Shanghai zip: 200071 country: China name: Shifen Xu, PhD role: CONTACT phone: +8613761931393 email: xu_teacher2006@126.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06316297 id: VBE00001 id: U1111-1295-3154 type: REGISTRY domain: ICTRP briefTitle: Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne overallStatus: RECRUITING date: 2024-04-05 date: 2027-12-22 date: 2027-12-23 date: 2024-03-18 date: 2024-04-26 name: Sanofi Pasteur, a Sanofi Company class: INDUSTRY briefSummary: The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of one or two intramuscular injections of the Acne mRNA vaccine candidate at three dose levels in adult participants aged 18 to 45 years with moderate to severe acne in the US. conditions: Acne studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Sequential and parallel design primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Sponsor study staff involved in early safety data reviews (ESDRs) will be unblinded at the time of the ESDR whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 386 type: ESTIMATED name: Acne mRNA vaccine name: Placebo measure: Number of participants with unsolicited systemic AEs measure: Number of participants with solicited injection site and systemic reactions measure: Number of participants with unsolicited AEs measure: Number of participants with MAAEs measure: Number of patients with SAEs measure: Number of patients with related SAEs, fatal SAEs and AESIs measure: Change in grade from baseline in biological test results measure: Absolute change from baseline in the number of inflammatory acne lesions on face measure: Percentage change from baseline in the number of inflammatory acne lesions on face measure: Absolute change from baseline in the number of non-inflammatory acne lesions on face measure: Percentage change from baseline in the number of non-inflammatory acne lesions on face measure: At least two-grade improvement in IGA scores measure: Assessment of vaccine-antigen-specific serum antibody titers sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: True Blue Clinical Research Site Number : 8400016 status: RECRUITING city: Brandon state: Florida zip: 33511 country: United States lat: 27.9378 lon: -82.28592 facility: Jacksonville Center for Clinical Research Site Number : 8400006 status: RECRUITING city: Jacksonville state: Florida zip: 32216 country: United States lat: 30.33218 lon: -81.65565 facility: DelRicht Research Site Number : 8400013 status: RECRUITING city: New Orleans state: Louisiana zip: 70115 country: United States lat: 29.95465 lon: -90.07507 facility: Metro Boston Clinical Partners Site Number : 8400008 status: RECRUITING city: Brighton state: Massachusetts zip: 02135 country: United States lat: 42.3501 lon: -71.15644 facility: DermResearch Center of New York, Inc Site Number : 8400010 status: RECRUITING city: Stony Brook state: New York zip: 11790 country: United States lat: 40.92565 lon: -73.14094 facility: Lynn Health Science Institute (LHSI) Site Number : 8400004 status: RECRUITING city: Oklahoma City state: Oklahoma zip: 73112 country: United States lat: 35.46756 lon: -97.51643 facility: Dermresearch Site Number : 8400009 status: RECRUITING city: Austin state: Texas zip: 78759 country: United States lat: 30.26715 lon: -97.74306 facility: Center for Clinical Studies, LTD. LLP Site Number : 8400002 status: RECRUITING city: Houston state: Texas zip: 77004 country: United States lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06316284 id: miRNA-CKD briefTitle: miRNA in Chronic Kidney Diseases overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2026-12-31 date: 2024-03-18 date: 2024-03-18 name: Josip Juraj Strossmayer University of Osijek class: OTHER name: University Hospital Center Osijek briefSummary: Oxidative stress and endoplasmic reticulum (ER) stress play a key role in tubular damage in both acute kidney injury and chronic kidney disease (CKD). Oxidative stress in the kidneys promotes renal vascular remodeling and increases preglomerular resistance. These are key elements in hypertension, acute and chronic kidney injury, as well as diabetic nephropathy. Chronic renal hypoxia is highlighted as the final common pathway to end-stage renal disease (ESRD). MicroRNA molecules (miRNA) also play an important role in these processes. MicroRNAs (miRNAs) are regulators of gene expression and play a role in the progression of renal ischemia-reperfusion injury. Although the pathophysiological contribution of microRNAs (miRNAs) to kidney damage has also been highlighted, the effect of miRNAs on kidney damage under conditions of oxidative and ER stress remains understudied. conditions: Chronic Kidney Diseases studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 90 type: ESTIMATED measure: Systemic microvascular function measure: Serum level of antixidant enzymesprotein concentration of SOD, CAT and glutathione-peroxidase measure: Detecton of miRNA of interest measure: Body fluid compartments sex: ALL minimumAge: 18 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine Osijek city: Osijek zip: 31000 country: Croatia lat: 45.55111 lon: 18.69389 hasResults: False

 nctId: NCT06316271 id: PreHT 2024 briefTitle: Endothelial Function in Prehypertension overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2026-12-31 date: 2024-03-18 date: 2024-03-18 name: Josip Juraj Strossmayer University of Osijek class: OTHER name: University Hospital Center Osijek briefSummary: In the frame of this proposal investigators will test the hypothesis that high normal blood pressure (prehypertension; PreHT) induces systemic endothelial dysfunction and endothelial activation in both micro- and macrocirculation, reduces re-endothelialization potential of human endothelial progenitor cells (EPCs) and increases the level of endothelial extracellular vesicles (EVs), which are accompanied by increased oxidative stress level. Furthermore, initial vascular and left ventricle (LV) remodeling contributes to changes in systemic hemodynamics and may be influenced by altered regulatory role of renin-angiotensin system (RAS) and autonomic nervous system (ANS) in PreHT but otherwise healthy individuals. To distinguish high normal blood pressure effect from those considered normal or high, study will be performed in three groups of individuals: prehypertensive (BP 130-139/85-89 mmHg), hypertensive (stage I, BP 140-150/90-100 mmHg), and controls (BP less than or equal to 129/85 mmHg). Altogether, the impairment of normal vascular relaxation mechanisms, endothelial activation as well as vascular and LV remodeling could play crucial role in increased cardiovascular risk and CVDs incidence in PreHT individuals. Moreover, the prognostic significance of assessing endotehlial dysfunction in hypertension (as well as in PreHT) is yet to be established. conditions: Hypertension,Essential studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 90 type: ESTIMATED measure: Systemic microvascular function measure: Systemic macrovascular function measure: Aortic stiffness measure: Left ventricle global longitudinal strain measure: Oxidative stress - 8-iso-prostaglandin F2α (8-iso-PGF2α) measure: Activity of renin-angiotensin system (RAS) measure: Endothelial progenitor cells (EPCs) measure: Endothelial extracellular vesicles (eEVs) measure: Systemic peripheral vascular resistance measure: Autonomic nervous system (ANS) activity measure: Matrix metalloproteinase 9 sex: ALL minimumAge: 18 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine Osijek city: Osijek zip: 31000 country: Croatia lat: 45.55111 lon: 18.69389 hasResults: False

 nctId: NCT06316258 id: 333112 briefTitle: Evaluating a CFT Group for Adults With Acquired Brain Injury overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-30 date: 2025-05-30 date: 2024-03-18 date: 2024-03-18 name: King's College London class: OTHER briefSummary: Emotional difficulties such as anxiety and depression are common after experiencing a brain injury. The compassion focused therapy (or CFT) model proposes the importance of developing skills in being able to self-soothe and be self-compassionate to counteract feelings of distress. Several studies have shown that therapy groups using CFT techniques are helpful, but there has only been one previous study of a CFT group with people with acquired brain injury. This study aims to evaluate a new CFT group for people who have had a brain injury and are currently receiving inpatient neuro-rehabilitation. The group will have six weekly sessions with 4-6 people in each group. The group will be run at the inpatient neuro-rehabilitation unit. As this is a new group that has not been run before, it will be a small study to see whether the group is feasible and acceptable to attendees. The study will evaluate whether the group can be run as planned and how many people attend. The investigators will also interview people who attended the group to find out what they thought of the group.

The study also aims to use four questionnaires measuring emotional distress, well-being, self-compassion and quality of life to measure the effect of the group. Group attendees questionnaire scores from before and after the group will be compared to see if there has been any change due to attending the group.

This project is being completed as part of a Doctorate in Clinical Psychology at King's College London, and will be recruiting patients from an inpatient neurorehabilitation setting. conditions: Acquired Brain Injury Including Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 12 type: ESTIMATED name: Compassion focused therapy group measure: Demand - patients referred and screened for the group measure: Demand - patients recruited measure: Demand - attendance measure: Implementation - patients per group measure: Implementation - group sessions completed measure: Implementation - practice sessions completed measure: Practicality - delivery of intervention measure: Acceptability - end of session ratings scores measure: Acceptability - patient interview feedback measure: Change in emotional distress questionnaire score measure: Change in mental well-being questionnaire score measure: Change in self-compassion questionnaire score measure: Change in quality of life questionnaire score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06316245 id: 2024/178 briefTitle: Functional Capacity and Days Alive Out of Hospital at 30 Days overallStatus: RECRUITING date: 2024-03-19 date: 2024-10-19 date: 2024-12-19 date: 2024-03-18 date: 2024-03-20 name: Istanbul University class: OTHER briefSummary: This prospective observational study aims to compare days alive and out of hospital at 30 days (DAOH-30) in patients with poor or good functional capacity undergoing gastrointestinal surgeries. The investigators are testing the hypothesis that patients with good functional capacity will have longer days alive and out of hospital than those with poor. conditions: Gastrointestinal Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 470 type: ESTIMATED name: DASI questionnaire measure: Days alive and out of hospital at 30 days (DAOH-30) measure: Days alive and out of hospital at 90 days (DAOH-90) measure: Postoperative complications measure: The Postoperative Morbidity Survey (POMS) defined morbidity measure: Mortality measure: Intensive care unit (ICU) stay measure: Length of hospital stay after index surgery measure: Rehospitalization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul University Istanbul Medical Faculty, Department of Anesthesiology and Reanimation status: RECRUITING city: Istanbul state: Fatih zip: 34093 country: Turkey name: Muserref B Dincer role: CONTACT phone: +905321624712 email: mberildincer@gmail.com name: Ahmet K Koltka role: CONTACT email: koltkak@yahoo.com name: Muserref B Dincer role: PRINCIPAL_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06316232 id: DBS-FOG 2023 briefTitle: DBS and Levodopa for Treating Freezing of Gait in Parkinson's Disease overallStatus: RECRUITING date: 2023-10-10 date: 2026-12-31 date: 2026-12-31 date: 2024-03-18 date: 2024-03-18 name: IRCCS Istituto delle Scienze Neurologiche di Bologna class: OTHER name: Azienda Ospedaliera Città della Salute e della Scienza di Torino briefSummary: Freezing of gait (FoG) is a complex symptom of Parkinson's disease (PD) that cause falls and disability in PD patients, heavily affect patients' autonomy and quality of life. Gait disturbances and FoG are difficult to manage as they usually do not complete respond to both dopaminergic treatment and subthalamic nucleus deep brain stimulation (STN-DBS). One therapeutic strategy suggested in literature for improving gait disturbances is to increase the dose of dopaminergic drugs according to the hypothesis of pseudo-ON-freezing. The pseudo-ON-FoG in patients treated with STN-DBS can easily occur as the result of a suboptimal stimulation or the consequence of a post-operative reduction of the dopaminergic therapy. Therefore, it is reasonable hypothesize both the increase of stimulation and levodopa as good therapeutic strategies to improve pseudo-ON-FoG. At present there are no evidence for suppose that one option is better than the other, even though two recent studies on gait analysis reported a positive additive effect of levodopa therapy on gait parameters in patients treated with STN-DBS.

In this study, the investigators aim to objectively evaluating the improvement of FoG in PD patients treated with STN-DBS at different treatment conditions consisting of increased intensity of stimulation or higher dosage of levodopa. conditions: Freezing of Gait conditions: Parkinson Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: In addition to baseline gait assessment performed in a morning session on MED ON/STIM ON condition (after usual levodopa morning dose and usual parameters of stimulation), patients are evaluated in two following morning sessions under different treatment conditions:

1. STIM ON plus: evaluation after the administration of levodopa morning dose and the increase of intensity of stimulation of 0.5 mA bilaterally,
2. MED ON plus: evaluation after the administration of a 2x levodopa morning dose with usual parameters of stimulation. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The count and duration of FoG episodes during the standardize walking protocol is measured on video-assessment by two blind raters. whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: STIM ON plus name: MED ON plus measure: Time spent with FOG during protocol measure: Gait performance measure: MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III measure: Patient global impression of change (PGI-C) measure: Trail Making test A and B measure: Phonemic/Semantic alternate Fluency test sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto delle Scienze Neurologiche di Bologna status: RECRUITING city: Bologna zip: 40139 country: Italy name: Ilaria Cani role: CONTACT phone: 0039 051 4966959 email: ilaria.cani@studio.unibo.it name: Giulia Giannini role: CONTACT phone: 0039 051 4966959 email: giulia.giannini15@unibo.it name: Giovanna Calandra Buonaura, MD, PhD role: SUB_INVESTIGATOR name: Ilaria Cani, MD role: SUB_INVESTIGATOR name: Carlo Alberto Artusi, MD, PhD role: SUB_INVESTIGATOR name: Giulia Giannini, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 44.49381 lon: 11.33875 hasResults: False

 nctId: NCT06316219 id: ZOEPREP briefTitle: The Use of Nomegestrol Acetate/Estradiol in Random Start Rapid Endometrial Preparation overallStatus: COMPLETED date: 2023-01-01 date: 2023-08-01 date: 2024-03-01 date: 2024-03-18 date: 2024-04-08 name: University of Palermo class: OTHER name: University of Roma La Sapienza briefSummary: The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Nomegestrol Acetate/Estradiol, in rapid preparation of endometrium for hysteroscopic polypectomy. conditions: Endometrial Polyp conditions: Endometrial Diseases studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ACTUAL name: Nomegestrol Acetate/Estradiol 2.5mg/1.5mg measure: Quality of endometrial preparation sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Andrea Etrusco city: Palermo zip: 90123 country: Italy lat: 38.13205 lon: 13.33561 facility: Marco Monti city: Rome zip: 00161 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06316206 id: EFFIPREP briefTitle: The Use of Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation overallStatus: COMPLETED date: 2023-01-01 date: 2023-08-01 date: 2024-03-01 date: 2024-03-18 date: 2024-04-22 name: University of Palermo class: OTHER name: University of Roma La Sapienza briefSummary: The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Ethinylestradiol/Dienogest, in rapid preparation of endometrium for hysteroscopic polypectomy. conditions: Endometrial Polyp conditions: Endometrial Diseases studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ACTUAL name: Ethinylestradiol/Dienogest 0.03mg/2mg measure: Quality of endometrial preparation sex: FEMALE minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Andrea Etrusco city: Palermo zip: 90123 country: Italy lat: 38.13205 lon: 13.33561 facility: Marco Monti city: Roma zip: 00161 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06316193 id: DiaPaNeo briefTitle: The Use of the Diary in Neonatal Pathology: a Mixed-method Study for Collecting and Analyzing the Experience of Parents and Health Care Personnel. acronym: DiaPaNeo overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-15 date: 2025-10-15 date: 2024-03-18 date: 2024-03-18 name: IRCCS Ospedale San Raffaele class: OTHER briefSummary: The study is mixed-methods (qualitative + quantitative observational cross-sectional) and the aims are to explore the use of diaries by parents of newborns admitted to Neonatal Pathology and to describe some variables related to their experience during their children's hospitalization, such as: stress level, postpartum depression and perceived support. The diary that will be analyzed is already part of current clinical practice. Study population:

* Parents of premature infants with gestational age less than or equal to 35 weeks and infants with birth weight less than or equal to 2kg admitted to Neonatal Pathology of San Raffaele Hospital.
* Health workers of the O.U. of Neonatal Pathology. conditions: Experience, Life conditions: Stress conditions: Depression, Postpartum conditions: Support, Family studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 15 type: ESTIMATED name: Diary measure: The objective of the qualitative phase is to provide a description of the experience of the parents of infants admitted to Neonatal Pathology and the healthcare personnel who participated in the compilation of the diary. measure: The quantitative phase includes as data collection tools a set of instruments validated in the Italian context and selected in relation to the variables to be measured. The instruments will be administered by one of the appropriately trained nurses. measure: The quantitative phase includes as data collection tools a set of instruments validated in the Italian context and selected in relation to the variables to be measured. Stressor Scale (PSS). measure: The quantitative phase includes as data collection tools a set of instruments validated in the Italian context and selected in relation to the variables to be measured. Edinburgh Postnatal Depression Scale (EPDS). measure: The quantitative phase includes as data collection tools a set of instruments validated in the Italian context and selected in relation to the variables to be measured. The Nurse Parental Support Tool (NPST). sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale San Raffaele city: Milano state: MI zip: 20132 country: Italy name: Roberta Ranzani role: CONTACT phone: +393408896175 email: ranzani.roberta@hsr.it name: Alessia De simone role: CONTACT phone: +393311637516 email: desimone.alessia@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06316180 id: DROVPREP briefTitle: The Use of Drospirenone/Estetrol in Random Start Rapid Endometrial Preparation overallStatus: COMPLETED date: 2023-01-01 date: 2023-08-01 date: 2024-03-01 date: 2024-03-18 date: 2024-04-08 name: University of Palermo class: OTHER name: University of Roma La Sapienza briefSummary: The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of drospirenone/estetrol, in rapid preparation of endometrium for hysteroscopic polypectomy. conditions: Endometrial Polyp conditions: Endometrial Diseases studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ACTUAL name: drospirenone/estetrol 3mg/14.2mg measure: Quality of endometrial preparation sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Andrea Etrusco city: Palermo zip: 90123 country: Italy lat: 38.13205 lon: 13.33561 facility: Marco Monti city: Rome zip: 00161 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06316167 id: Hiatoplasty-2024 briefTitle: Mandatory Hiatoplasty in Sleeve Gastrectomy for Gastro-Esophageal Reflux Disease overallStatus: RECRUITING date: 2024-03-01 date: 2024-07-31 date: 2024-08-31 date: 2024-03-18 date: 2024-03-18 name: Instituto Mexicano del Seguro Social class: OTHER_GOV briefSummary: The goal of this observational study is to learn about incidence of postoperative gastroesophageal reflux disease in mandatory hiatoplasty performed during gastric sleeve surgery.

The main question\[s\] it aims to answer are:

* Incidence of postoperative GERD in patients undergoing gastric sleeve with mandatory hiatoplasty
* Comparison of postoperative complication rates, including GERD

Participants will answer a follow-up questionnaire, about postoperative quality of life conditions: Postgastrectomy Syndromes conditions: Gastroesophageal Reflux studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 275 type: ESTIMATED measure: Number of participants without postoperative GERD measure: Comorbidities in patients undergoing gastric sleeve with hiatoplasty measure: Incidence of postoperative GERD in patients undergoing gastric sleeve with mandatory hiatoplasty measure: Comparison of postoperative complication rates, including GERD measure: Postoperative quality of life analysis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Unidad de Investigación Biomédica 02, Unidad Médica de alta especialidad, Hospital de Especialidades Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara 44329, Mexico status: RECRUITING city: Guadalajara state: Jalisco zip: 44329 country: Mexico name: Alejandro González-Ojeda, MD, PhD role: CONTACT phone: 3331294165 email: avygail5@gmail.com lat: 20.66682 lon: -103.39182 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-10 uploadDate: 2024-03-11T14:29 filename: Prot_000.pdf size: 2544381 hasResults: False

 nctId: NCT06316154 id: 12032024 briefTitle: Presentation of Protoscolexes and Acephalocysts in the Fibrous Capsule Area of the Liver With Echinococcosis acronym: PAFCLE overallStatus: RECRUITING date: 2023-10-22 date: 2024-10-22 date: 2024-12-22 date: 2024-03-18 date: 2024-03-18 name: Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov class: OTHER briefSummary: The objective of the study is to determine the presence of germinal elements of echinococcosis in the liver parenchyma next to and in the thickness of the fibrous capsule of hydatid cysts. conditions: Echinococcosis, Hepatic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Echinococcectomy measure: Presence of viable germinal elements of echinococcosis measure: Recurrence of liver echinococcosis sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Republican specialized scientific and practical medical center of surgery named after academician V.Vakhidov status: RECRUITING city: Tashkent zip: 100115 country: Uzbekistan name: Azam Babadjanov, Professor role: CONTACT phone: +998901751703 email: azam746@mail.ru lat: 41.26465 lon: 69.21627 hasResults: False

 nctId: NCT06316141 id: REC/RCR&AHS/23/0352 briefTitle: Effects of Aquatic vs Land Based Jogging in Overweight overallStatus: COMPLETED date: 2023-05-23 date: 2024-01-30 date: 2024-02-15 date: 2024-03-18 date: 2024-03-18 name: Riphah International University class: OTHER briefSummary: Obesity raises the risk of chronic illnesses in adults, especially heart disease, type II diabetes, and osteoarthritis. One way to combat obesity is by physical activity, and water-based exercise (hydrotherapy) is recognized as an enhancement of the more common on land physical activity. Obesity is associated with several negative health outcomes, including cardiovascular disease (CVD), cardiac enlargement, gallbladder disease, diabetes, several cancers, osteoarthritis, and sleeping disorders .In addition to being a significant predictor of coronary heart disease and heart failure. obesity is indirectly related to cardiovascular health through its association with several other CVD risk factors, including hypertension, high cholesterol, low high-density lipoprotein (HDL) cholesterol, high triglycerides, and diabetes Therefore, obesity is a primary target for interventions to decrease overall cardiovascular risk. It is a randomized clinical trial conducted at the University OF Central Punjab Lahore. Convenience sampling technique will be used .Participants will be recruited through simple random sampling by sealed opaque envelope method into two Groups .Group A and Group B. Group A:Aqua jogging group: This group will perform aqua jogging for 60 minutes consisting of 10 minutes warming up, 40 minutes aqua jogging or land jogging and 10 minutes cooling down. Group B: Land based jogging group: This group will perform land jogging for 60 minutes consisting of 10 minutes warming up, 40 minutes aqua jogging or land jogging and 10 minutes cooling down. Assessment tools for this study will be cooper's 1.5 miles run test for cardiorespiratory endurance and health related quality of life questionnaire for Quality of life. The study will be completed within 10 months after synopsis approval from ethical Committee of RCRS \& AHS .Data will be entered and analysed by SPSS version 25. After assessing the normality of data, it will be decided either parametric or non-parametric test will be use within a group or between two groups. conditions: Overweight studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ACTUAL name: Aqua Jogging name: Land based Jogging measure: Cardiorespiratory Endurance(cooper; s1.5 miles run) measure: Quality of life (health related QOL SF 36 Questionnaire) measure: BMI sex: ALL minimumAge: 20 Years maximumAge: 59 Years stdAges: ADULT facility: University of Central Punjab (sports complex) Lahore. city: Lahore state: Punjab zip: 42000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06316128 id: K26 briefTitle: EmploYEd Antithrombotic Therapies in Patients With Acute Coronary Syndromes HOspitalized in iTalian CCUs acronym: EYESHOT-2 overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-01 date: 2024-03-29 date: 2024-03-29 date: 2024-03-18 date: 2024-03-18 name: Heart Care Foundation class: OTHER briefSummary: This registry has the aim to assess the use of different antithrombotic therapies, including untested drug combinations, routinely used during the hospitalization phase, with their timing, route and dose of administration, in consecutive patients discharged with a diagnosis NSTEMI or STEMI in Italian Cardiac care Units (CCUs) during a four-week study period. conditions: Acute Coronary Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED measure: Antithrombotic therapies measure: Assessment of in-hospital clinical events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale Santo Spirito - Sc Cardiologia city: Casale state: AL zip: 15033 country: Italy lat: 41.21972 lon: 14.00231 facility: Ospedali Riuniti - Sod Cardiologia Ospedaliera E Utic city: Ancona state: AN zip: 60122 country: Italy lat: 43.5942 lon: 13.50337 facility: Irccs Inrca - Uo Cardiologia/Utic/Telecardiologia city: Ancona state: AN zip: 60131 country: Italy lat: 43.5942 lon: 13.50337 facility: Ospedale San Donato - U.O.C Cardiologia city: Arezzo state: AR zip: 52100 country: Italy lat: 43.46276 lon: 11.88068 facility: Ospedale Valdarno S. Maria Della Gruccia - U.O. Malattie Cardiovascolari city: Montevarchi state: AR zip: 52027 country: Italy lat: 43.5252 lon: 11.57238 facility: Aorn San Giuseppe Moscati - U.O. Cardiologia/Utic 'D. Rotiroti' city: Avellino state: AV zip: 83100 country: Italy lat: 40.91494 lon: 14.79103 facility: Ospedale Miulli - U.O.C. Cardiologia - Utic city: Acquaviva Delle Fonti state: BA zip: 70021 country: Italy lat: 40.89704 lon: 16.8433 facility: Ospedale Della Murgia - Fabio Perinei - S.C. Cardiologia-Utic city: Altamura state: BA zip: 70022 country: Italy lat: 40.82664 lon: 16.54952 facility: Ospedale San Paolo - Cardiologia-Utic city: Bari state: BA zip: 70123 country: Italy lat: 41.11148 lon: 16.8554 facility: Aou Policlinico - Uoc Cardiologia Ospedaliera city: Bari state: BA zip: 70124 country: Italy lat: 41.11148 lon: 16.8554 facility: Ospedale Di Venere - U.O.C. Di Cardiologia city: Carbonara Di Bari state: BA zip: 70012 country: Italy lat: 41.06667 lon: 16.86667 facility: Ospedale Bolognini - Cardiologia E Unita' Coronarica city: Seriate state: BG zip: 24068 country: Italy lat: 45.68532 lon: 9.72487 facility: Ospedali Treviglio-Caravaggio - Cardiologia city: Treviglio state: BG zip: 24047 country: Italy lat: 45.52081 lon: 9.59102 facility: Ospedale Degli Infermi - Sc Di Cardiologia city: Ponderano state: BI zip: 13875 country: Italy lat: 45.53846 lon: 8.05592 facility: Presidio Ospedaliero "Santa Maria Del Prato" - U.O.C. Di Cardiologia-Utic city: Feltre state: BL zip: 32032 country: Italy lat: 46.02085 lon: 11.90031 facility: Ospedale Di Bentivoglio - U.O. Cardiologia Pianura city: Bentivoglio state: BO zip: 40010 country: Italy lat: 44.6369 lon: 11.41737 facility: Ospedale Maggiore - U.O.C. Di Cardiologia city: Bologna state: BO zip: 40133 country: Italy lat: 44.49381 lon: 11.33875 facility: Ospedale Policlinico S. Orsola-Malpighi - U.O. Cardiologia-Galie' city: Bologna state: BO zip: 40138 country: Italy lat: 44.49381 lon: 11.33875 facility: Ospedale Perrino - U.O.C. Di Cardiologia city: Brindisi state: BR zip: 72100 country: Italy lat: 40.63215 lon: 17.93607 facility: Asst Spedali Civili - Cardiologia city: Brescia state: BS zip: 25123 country: Italy lat: 45.53558 lon: 10.21472 facility: Asst Franciacorta - Presidio Chiari - Cardiologia/Utic city: Chiari state: BS zip: 25032 country: Italy lat: 45.53763 lon: 9.92699 facility: Ospedale Di Desenzano Del Garda - Divisione Di Cardiologia - U.C.C. city: Desenzano Del Garda state: BS zip: 25015 country: Italy lat: 45.47127 lon: 10.53559 facility: Ospedale Civile 'La Memoria' - U.O. Di Cardiologia city: Gavardo state: BS zip: 25085 country: Italy lat: 45.58939 lon: 10.44257 facility: Istituto Clinico San Rocco - Unita' Operativa Di Cardiologia city: OME state: BS zip: 25050 country: Italy lat: 45.62728 lon: 10.12137 facility: Ospedale Centrale Bolzano - Cardiologia E Prove Funzionali city: Bolzano state: BZ zip: 39100 country: Italy lat: 46.49067 lon: 11.33982 facility: Arnas G. Brotzu - Cardiologia Con Utic city: Cagliari state: CA zip: 09134 country: Italy lat: 39.23054 lon: 9.11917 facility: A.O.U. Cagliari Policlinico Monserrato - Sc Cardiologia Utic Emodinamica city: Monserrato state: CA zip: 09124 country: Italy lat: 39.25642 lon: 9.1444 facility: Ospedale A. Cardarelli - U.O. Cardiologia E Utic city: Campobasso state: CB zip: 86100 country: Italy lat: 41.55947 lon: 14.66737 facility: Presidio Ospedaliero Moscati - U.O.C. Cardiologia-Utic city: Aversa state: CE zip: 81031 country: Italy lat: 40.97259 lon: 14.20745 facility: Azienda Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia D'Emergenza Con Utic city: Caserta state: CE zip: 81100 country: Italy lat: 41.07262 lon: 14.33231 facility: Casa Di Cura San Michele - Uo Cardiologia city: Maddaloni state: CE zip: 81024 country: Italy lat: 41.03578 lon: 14.3823 facility: Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic city: Santa Maria Capua Vetere state: CE zip: 81055 country: Italy lat: 41.08156 lon: 14.25342 facility: Presidio Ospedaliero San Rocco - U.O.C. Cardiologia - Utic city: Sessa Aurunca state: CE zip: 81037 country: Italy lat: 41.23987 lon: 13.92966 facility: Ospedale Policlinico Ss. Annunziata - Uoc Cardiologia-Utic city: Chieti state: CH zip: 66013 country: Italy lat: 42.34827 lon: 14.16494 facility: Azienda Ospedaliera Santa Croce E Carle - Sc Cardiologia city: Cuneo state: CN zip: 12100 country: Italy lat: 44.39071 lon: 7.54828 facility: Ospedale Pietro E Michele Ferrero - Cardiologia E Utic city: Verduno state: CN zip: 12060 country: Italy lat: 44.66614 lon: 7.93074 facility: Ospedale Moriggia Pelascini - Unita' Operativa Di Cardiologia city: Gravedona state: CO zip: 22015 country: Italy lat: 46.14639 lon: 9.30094 facility: Ospedale Maggiore - U.O. Cardiologia E Utic city: Crema state: CR zip: 26013 country: Italy lat: 45.36264 lon: 9.68176 facility: P.O. "Pugliese" - A.O.U. "Renato Dulbecco" - Utic-Emodinamica E Cardiologia Interventistica city: Catanzaro state: CZ zip: 88100 country: Italy lat: 38.88247 lon: 16.60086 facility: Ospedale M. Bufalini - U.O. Di Cardiologia-Utic city: Cesena state: FC zip: 47521 country: Italy lat: 44.1391 lon: 12.24315 facility: Ospedale G.B. Morgagni - L. Pierantoni - U.O. Cardiologia city: Forli' state: FC zip: 47121 country: Italy lat: 44.22177 lon: 12.04144 facility: Arcispedale Sant'Anna - U.O. Cardiologia city: Ferrara state: FE zip: 44124 country: Italy lat: 44.83804 lon: 11.62057 facility: Policlinico Riuniti - S.C. Di Cardiologia Universitaria-Utic city: Foggia state: FG zip: 71100 country: Italy lat: 41.45845 lon: 15.55188 facility: Ospedale Casa Sollievo Della Sofferenza - Cardiologia - Utic - Riabil Cardiologica city: San Giovanni Rotondo state: FG zip: 71013 country: Italy lat: 41.70643 lon: 15.7277 facility: Ospedale Santa Maria Annunziata - Sos Cardiologia Clinica city: Bagno A Ripoli state: FI zip: 50011 country: Italy lat: 43.75115 lon: 11.32252 facility: Ospedale San Giuseppe - Cardiologia city: Empoli state: FI zip: 50053 country: Italy lat: 43.71795 lon: 10.94758 facility: Ospedale Santa Maria Nuova - Cardiologia city: Firenze state: FI zip: 50122 country: Italy lat: 43.77925 lon: 11.24626 facility: Aou Careggi - Interventistica Cardiologica Strutturale city: Firenze state: FI zip: 50134 country: Italy lat: 43.77925 lon: 11.24626 facility: Ospedale Padre Antero Micone - Sc Cardiologia - Utic city: Genova state: GE zip: 16100 country: Italy lat: 44.40478 lon: 8.94438 facility: Ospedale Villa Scassi - Asl 3 Ligure - Sc Cardiologia Utic city: Genova state: GE zip: 16149 country: Italy lat: 44.40478 lon: 8.94438 facility: Ospedale Del Tigullio Polo Lavagna - Sc Cardiologia E Utic city: Lavagna state: GE zip: 16033 country: Italy lat: 44.3062 lon: 9.35383 facility: Presidio Ospedaliero - U.O. Cardiologia city: Sanremo state: IM zip: 18038 country: Italy lat: 43.81725 lon: 7.7772 facility: Ospedale San Leopoldo Mandic - Cardiologia - Ucc city: Merate state: LC zip: 23807 country: Italy lat: 45.68858 lon: 9.4208 facility: Ospedale Vito Fazzi - Uoc Cardiologia-Utic Ed Emodinamica city: Lecce state: LE zip: 73100 country: Italy lat: 40.35481 lon: 18.17244 facility: Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic "E. Vilei" city: Scorrano state: LE zip: 73020 country: Italy lat: 40.09018 lon: 18.29993 facility: Azienda Osp. Cardinale G. Panico - U.O. Cardiologia - Utic city: Tricase state: LE zip: 73039 country: Italy lat: 39.93018 lon: 18.35421 facility: Ospedale Civile Bassa Val Di Cecina - Unita Operativa Di Cardiologia E Utic city: Cecina state: LI zip: 57023 country: Italy lat: 43.30621 lon: 10.51729 facility: Ospedali Riuniti - U.O.C. Cardiologia E Utic city: Livorno state: LI zip: 57124 country: Italy lat: 43.54427 lon: 10.32615 facility: Ospedale Villamarina - Cardiologia E Utic Piombino Elba city: Piombino state: LI zip: 57025 country: Italy lat: 42.92554 lon: 10.52585 facility: Ospedale Maggiore Di Lodi - U.O.C. Cardiologia city: Lodi state: LO zip: 26900 country: Italy lat: 45.30989 lon: 9.50085 facility: Nuovo Ospedale Versilia - Sc Cardiologia city: Camaiore state: LU zip: 55041 country: Italy lat: 43.94265 lon: 10.29754 facility: Ospedale Santa Croce - Uosd Cardiologia E Di Continuita Assist. city: Castelnuovo Di Garfagnana state: LU zip: 55032 country: Italy lat: 44.1126 lon: 10.40518 facility: Ospedale Pio Xi - U.O.C. Di Cardiologia city: Desio state: MB zip: 20832 country: Italy lat: 45.61831 lon: 9.20249 facility: Fondazione Irccs San Gerardo Dei Tintori - Ospedale San Gerardo - U.O.C. Cardiologia city: Monza state: MB zip: 20900 country: Italy lat: 45.58005 lon: 9.27246 facility: Nuovo Ospedale Di Vimercate - S.C. Cardiologia E Utic city: Vimercate state: MB zip: 20871 country: Italy lat: 45.61545 lon: 9.36801 facility: Presidio Osp. Di Civitanova Marche - Sc Cardiologia city: Civitanova Marche state: MC zip: 62012 country: Italy lat: 43.30491 lon: 13.72068 facility: Irccs Centro Neurolesi Bonino Pulejo - P.O. Piemonte - Cardiologia E Utic city: Messina state: ME zip: 98124 country: Italy lat: 38.19394 lon: 15.55256 facility: Humanitas Gavazzeni - U.O. Cardiologia city: Bergamo state: MI zip: 24125 country: Italy lat: 45.69601 lon: 9.66721 facility: Ospedale Di Cernusco Sul Naviglio - U. O. Di Cardiologia E Ucc city: Cernusco Sul Naviglio state: MI zip: 20063 country: Italy lat: 45.52526 lon: 9.33297 facility: Ospedale Edoardo Bassini - Sc Cardiologia-Ucc Asst Nord Milano (Bassini-Ssg) city: Cinisello Balsamo state: MI zip: 20092 country: Italy lat: 45.55823 lon: 9.21495 facility: Asst Ovest Milanese - Po Di Legnano - Cardiologia E Unita' Coronarica city: Legnano state: MI zip: 20025 country: Italy lat: 45.59788 lon: 8.91506 facility: Ospedale Civile Fornaroli - U.O. Cardiologia city: Magenta state: MI zip: 20013 country: Italy lat: 45.46456 lon: 8.88453 facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico - Uoc Malattie Cardiovascolari city: Milano state: MI zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 facility: Centro Cardiologico Monzino Irccs - Terapia Intensiva Cardiologica (Utic) city: Milano state: MI zip: 20138 country: Italy lat: 45.46427 lon: 9.18951 facility: Ospedale San Luca Irccs - Istituto Auxologico - Area Critica Cardiologica city: Milano state: MI zip: 20149 country: Italy lat: 45.46427 lon: 9.18951 facility: ASST SANTI PAOLO E CARLO - PO San Carlo - CARDIOLOGIA-UCC city: Milano state: MI zip: 20153 country: Italy lat: 45.46427 lon: 9.18951 facility: Ospedale L. Sacco - Sc Cardiologia city: Milano state: MI zip: 20157 country: Italy lat: 45.46427 lon: 9.18951 facility: Asst Ospedale Metropolitano Niguarda - Cardiologia 1 - Emodinamica city: Milano state: MI zip: 20162 country: Italy lat: 45.46427 lon: 9.18951 facility: Ospedale Civile - Unita' Operativa Di Cardiologia city: RHO state: MI zip: 20017 country: Italy lat: 45.53245 lon: 9.0402 facility: Istituto Clinico Humanitas - Irccs - Cardiologia Clinica, Interventistica E Ucc city: Rozzano state: MI zip: 20089 country: Italy lat: 45.38193 lon: 9.1559 facility: Irccs Policlinico San Donato - U.O. Cardiologia Con Utic city: San Donato Milanese state: MI zip: 20097 country: Italy lat: 45.41047 lon: 9.26838 facility: Irccs Policlinico Multimedica - Uo Di Cardiologia city: Sesto San Giovanni state: MI zip: 20099 country: Italy lat: 45.53329 lon: 9.22585 facility: Ospedale Madonna Delle Grazie - Ssd Utic city: Matera state: Mount zip: 75100 country: Italy lat: 40.66599 lon: 16.60463 facility: Ospedale Civile Di Baggiovara - U.O. Di Cardiologia city: Modena state: MO zip: 41126 country: Italy lat: 44.64783 lon: 10.92539 facility: Ospedale Di Sassuolo - Cardiologia city: Sassuolo state: MO zip: 41049 country: Italy lat: 44.5432 lon: 10.7848 facility: Ospedale Apuane - U.O. Cardiologia-Utic city: Massa state: MS zip: 54100 country: Italy lat: 44.03541 lon: 10.13927 facility: Ospedale San Francesco - Cardiologia - Utic city: Nuoro state: NU zip: 08100 country: Italy lat: 40.31991 lon: 9.32568 facility: Ospedale Giovanni Paolo Ii - Utic - Cardiologia city: Olbia state: OT zip: 07026 country: Italy lat: 40.92337 lon: 9.49802 facility: Fondazione G. Giglio - U.O. Di Cardiologia city: Cefalu' state: PA zip: 90015 country: Italy lat: 38.03856 lon: 14.02285 facility: Aou Policlinico P. Giaccone - U.O.C. Cardiologia city: Palermo state: PA zip: 90127 country: Italy lat: 38.13205 lon: 13.33561 facility: Arnas P.O. Civico E Benfratelli - Uoc Utic city: Palermo state: PA zip: 90127 country: Italy lat: 38.13205 lon: 13.33561 facility: Ospedale G.F. Ingrassia - Cardiologia - Utic city: Palermo state: PA zip: 90129 country: Italy lat: 38.13205 lon: 13.33561 facility: Maria Eleonora Hospital - Cardiologia city: Palermo state: PA zip: 90135 country: Italy lat: 38.13205 lon: 13.33561 facility: Aor Villa Sofia-Cervello P.O. Cervello - U.O. Cardiologia - Cervello city: Palermo state: PA zip: 90146 country: Italy lat: 38.13205 lon: 13.33561 facility: Aor Villa Sofia-Cervello Po Villa Sofia - Uoc Cardiologia E Utic E Emodinamica -Villa Sofia city: Palermo state: PA zip: 90146 country: Italy lat: 38.13205 lon: 13.33561 facility: Ospedale Civile 'Guglielmo Da Saliceto' - Uoc Cardiologia E Utic city: Piacenza state: PC zip: 29100 country: Italy lat: 45.05242 lon: 9.69342 facility: Ospedale Civile Dello Spirito Santo - Cardiologia Con Utic city: Pescara state: PE zip: 65124 country: Italy lat: 42.4584 lon: 14.20283 facility: Presidio Ospedaliero Citta' Di Castello - U.O. Cardiologia/Utic city: Citta' Di Castello state: PG zip: 06012 country: Italy lat: 43.46556 lon: 12.2375 facility: Nuovo Ospedale San Giovanni Battista - S.C. Cardiologia city: Foligno state: PG zip: 06034 country: Italy lat: 42.95488 lon: 12.70268 facility: Ospedale Gubbio-Gualdo Tadino - U.O. Di Utic E Cardiologia city: Gubbio state: PG zip: 06024 country: Italy lat: 43.34996 lon: 12.57309 facility: Azienda Ospedaliera Di Perugia - S.C. Cardiologia city: Perugia state: PG zip: 06129 country: Italy lat: 43.1122 lon: 12.38878 facility: Ftgm - Stabilimento Di Pisa - Cardiologia E Medicina Cardiovascolare city: Pisa state: PI zip: 56124 country: Italy lat: 43.70853 lon: 10.4036 facility: Ospedale Ss. Cosma E Damiano - Sos Cardiologia city: Pescia state: Point zip: 51017 country: Italy lat: 43.8871 lon: 10.68849 facility: Ospedale San Jacopo - Soc Cardiologia city: Pistoia state: Point zip: 51100 country: Italy lat: 43.93064 lon: 10.92365 facility: Ospedale Santo Stefano - U.O. Cardiologia city: Prato state: PO zip: 59100 country: Italy lat: 43.8805 lon: 11.09699 facility: Ospedale Civile - U.O.C. Cardiologia - Utic city: Fidenza state: PR zip: 43036 country: Italy lat: 44.86694 lon: 10.06039 facility: Azienda Ospedaliera Universitaria Parma - U.O.C. Di Cardiologia city: Parma state: PR zip: 43126 country: Italy lat: 44.79935 lon: 10.32618 facility: Presidio Ospedaliero San Salvatore - Cardiologia E Utic city: Pesaro state: PU zip: 61121 country: Italy lat: 43.90921 lon: 12.9164 facility: Fondazione Irccs Policlinico San Matteo - Uoc Cardiologia 1 city: Pavia state: PV zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 facility: Ospedale Civile - U.O. Di Cardiologia city: Voghera state: PV zip: 27058 country: Italy lat: 44.99151 lon: 9.01175 facility: Aor San Carlo - Ospedale San Carlo - Ssd Terapia Intensiva Cardiologica city: Potenza state: PZ zip: 85100 country: Italy lat: 40.64175 lon: 15.80794 facility: Ospedale Civile - Uo Servizio Cardiologia city: Lugo state: RA zip: 48022 country: Italy lat: 44.42137 lon: 11.91094 facility: Ospedale Civile Santa Maria Delle Croci - Uoc Cardiologia city: Ravenna state: RA zip: 48121 country: Italy lat: 44.41344 lon: 12.20121 facility: Grande Ospedale Metropolitano - Osp Riuniti Bianchi Melacrino - Uoc Cardiologia E Utic city: Reggio Calabria state: RC zip: 89124 country: Italy lat: 38.11047 lon: 15.66129 facility: Ospedale Civile Di Guastalla - Sos Cardiologia E Riabilitazione Card Area Nord city: Guastalla state: RE zip: 42016 country: Italy lat: 44.91172 lon: 10.66186 facility: Po Santa Maria Nuova - Ausl Re Irccs - Soc Cardiologia Ospedaliera city: Reggio Emilia state: RE zip: 42100 country: Italy lat: 44.69825 lon: 10.63125 facility: Ospedale Giovanni Paolo Ii - U.O.C. Cardiologia-Utic city: Ragusa state: RG zip: 97100 country: Italy lat: 36.92574 lon: 14.72443 facility: P.O. San Camillo de Lellis - U.O.C. Cardiologia city: Rieti state: RI zip: 02100 country: Italy lat: 42.40476 lon: 12.85735 facility: Ospedale Dei Castelli - U.O.C. Di Cardiologia E Utic city: Ariccia state: RM zip: 00072 country: Italy lat: 41.72063 lon: 12.6723 facility: European Hospital - U.O.C. Cardiologia Interventistica city: Roma state: RM zip: 00149 country: Italy lat: 41.89193 lon: 12.51133 facility: Ospedale San Camillo - Uoc Cardiologia city: Roma state: RM zip: 00152 country: Italy lat: 41.89193 lon: 12.51133 facility: Ospedale Sandro Pertini - Uoc Cardiologia city: Roma state: RM zip: 00157 country: Italy lat: 41.89193 lon: 12.51133 facility: Aurelia Hospital - U.O.C Cardiologia city: Roma state: RM zip: 00163 country: Italy lat: 41.89193 lon: 12.51133 facility: Policlinico Casilino - U.O.C. Cardiologia city: Roma state: RM zip: 00169 country: Italy lat: 41.89193 lon: 12.51133 facility: Ospedale Madre Giuseppina Vannini - U.O.C. Cardiologia city: Roma state: RM zip: 00177 country: Italy lat: 41.89193 lon: 12.51133 facility: Ospedale Isola Tiberina - Uoc Cardiologia Diagnostica Interventistica-Utic city: Roma state: RM zip: 00188 country: Italy lat: 41.89193 lon: 12.51133 facility: Ospedale Santo Spirito - Uoc Cardiologia city: Roma state: RM zip: 00193 country: Italy lat: 41.89193 lon: 12.51133 facility: Ospedale San Giovanni Evangelista - U.O.C. Di Cardiologia - Utic city: Tivoli state: RM zip: 00019 country: Italy lat: 41.95952 lon: 12.8016 facility: Ospedale Infermi - U.O. Cardiologia city: Rimini state: RN zip: 47900 country: Italy lat: 44.05755 lon: 12.56528 facility: Ospedale S. Maria Incoronata Dell'Olmo - U.O.C. Cardiologia-Utic city: Cava De' Tirreni state: SA zip: 84013 country: Italy lat: 40.69954 lon: 14.70773 facility: Ospedale Maria Ss. Addolorata - U.O. Di Cardiologia Utic city: Eboli state: SA zip: 84025 country: Italy lat: 40.61747 lon: 15.05693 facility: Presidio Ospedaliero Umberto I - Uoc Cardiologia - Utic city: Nocera Inferiore state: SA zip: 84014 country: Italy lat: 40.7454 lon: 14.64542 facility: Presidio Ospedaliero Luigi Curto - Uo Cardiologia-Utic city: Polla state: SA zip: 84035 country: Italy lat: 40.51433 lon: 15.49715 facility: Aou S. Giovanni Di Dio-Ruggi D'Aragona - Ssd Utic city: Salerno state: SA zip: 84131 country: Italy lat: 40.67545 lon: 14.79328 facility: Ospedale San Luca - U.O. Utic - Cardiologia city: Vallo Della Lucania state: SA zip: 84078 country: Italy lat: 40.22786 lon: 15.26635 facility: Ospedale Dell'Alta Val D'Elsa - Uosd Cardiologia-Utic city: Poggibonsi state: SI zip: 53036 country: Italy lat: 43.47064 lon: 11.14804 facility: Aou Senese Ospedale S. Maria Alle Scotte - Cardiologia city: Siena state: SI zip: 53100 country: Italy lat: 43.31822 lon: 11.33064 facility: Ospedale S. Andrea - S.C. Cardiologia city: La Spezia state: SP zip: 19124 country: Italy lat: 44.103 lon: 9.82375 facility: Ospedale E. Muscatello - U.O. Di Cardiologia - Utic city: Augusta state: SR zip: 96011 country: Italy lat: 37.24065 lon: 15.22121 facility: Ospedale G. Di Maria - Cardiologia Utic city: Avola state: SR zip: 96012 country: Italy lat: 36.9084 lon: 15.13937 facility: P.O. Lentini - Uosd Di Cardiologia Con Utic city: Lentini state: SR zip: 96016 country: Italy lat: 37.28556 lon: 14.99737 facility: Ospedale Ss. Annunziata - Cardiologia Clinica Ed Interventistica city: Sassari state: SS zip: 07100 country: Italy lat: 40.72586 lon: 8.55552 facility: Ospedale Nostra Signora Di Bonaria - U.O.C. Cardiologia E Utic city: San Gavino Monreale state: SU zip: 09037 country: Italy lat: 39.55008 lon: 8.79065 facility: Po Ponente - Ospedale Santa Corona - Sc Cardiologia Ponente city: Pietra Ligure state: SV zip: 17027 country: Italy lat: 44.1492 lon: 8.28206 facility: P.O. Levante - Ospedale San Paolo - S.C. Cardiologia Levante city: Savona state: SV zip: 17100 country: Italy lat: 44.30905 lon: 8.47715 facility: Ospedale Di Castellaneta - S.C. Cardiologia city: Castellaneta state: TA zip: 74011 country: Italy lat: 40.62794 lon: 16.9329 facility: Casa Di Cura Villa Verde - Cardiologia city: Taranto state: TA zip: 74100 country: Italy lat: 40.46435 lon: 17.24707 facility: Ospedale Ss. Annunziata - S.C. Cardiologia-Utic city: Taranto state: TA zip: 74100 country: Italy lat: 40.46435 lon: 17.24707 facility: Ospedale Santa Chiara - Divisione Di Cardiologia city: Trento state: TN zip: 38122 country: Italy lat: 46.06787 lon: 11.12108 facility: Ospedale Civico - Sc Cardiologia city: Chivasso state: TO zip: 10034 country: Italy lat: 45.19093 lon: 7.88981 facility: Por Cirie'- Lanzo Presidio Cirie' - S.C. Cardiologia city: Cirié state: TO zip: 10073 country: Italy lat: 45.23486 lon: 7.60125 facility: Ospedale Santa Croce - Cardiologia city: Moncalieri state: TO zip: 10024 country: Italy lat: 44.9994 lon: 7.68236 facility: Aou San Luigi Gonzaga - S.C.D.O. Cardiologia city: Orbassano state: TO zip: 10043 country: Italy lat: 45.00547 lon: 7.53813 facility: Ospedale Degli Infermi - Sc Cardiologia city: Rivoli state: TO zip: 10098 country: Italy lat: 45.07073 lon: 7.51465 facility: Aou Citta' Della Salute E Della Scienza - S.C. Cardiologia U city: Torino state: To zip: 10126 country: Italy lat: 45.07049 lon: 7.68682 facility: Ospedale Mauriziano Umberto I - Sc Cardiologia city: Torino state: TO zip: 10128 country: Italy lat: 45.07049 lon: 7.68682 facility: Ospedale Martini - Cardiologia (Mrt-Mv) city: Torino state: TO zip: 10142 country: Italy lat: 45.07049 lon: 7.68682 facility: Ospedale Maria Vittoria - Cardiologia (Mrt-Mv) city: Torino state: TO zip: 10149 country: Italy lat: 45.07049 lon: 7.68682 facility: Ospedale San Giovanni Bosco - Sc Cardiologia city: Torino state: TO zip: 10154 country: Italy lat: 45.07049 lon: 7.68682 facility: Po S. Antonio Abate Di Trapani - U.O.C. Di Cardiologia, Utic Ed Emodinamica city: Erice state: TP zip: 91016 country: Italy lat: 38.03785 lon: 12.58778 facility: Osp Abele Ajello - U.O.C. Cardiologia Con Utic city: Mazara Del Vallo state: TP zip: 91026 country: Italy lat: 37.65535 lon: 12.58987 facility: Ospedale San Valentino - U.O.C. Cardiologia city: Montebelluna state: TV zip: 31044 country: Italy lat: 45.77504 lon: 12.04904 facility: Ospedale Ca' Foncello - U.O.C. Cardiologia city: Treviso state: TV zip: 31100 country: Italy lat: 45.66673 lon: 12.2416 facility: Pou "Santa Maria Della Misericordia" - S.O.C. Cardiologia city: Udine state: UD zip: 33100 country: Italy lat: 46.0693 lon: 13.23715 facility: Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia city: Saronno state: VA zip: 21047 country: Italy lat: 45.62513 lon: 9.03517 facility: Ospedale San Biagio - Soc Cardiologia Vco city: Domodossola state: VB zip: 28845 country: Italy lat: 46.1165 lon: 8.29313 facility: Ospedale Castelli - Soc Cardiologia Vco city: Verbania state: VB zip: 28922 country: Italy lat: 45.92136 lon: 8.55183 facility: Ospedale Dell'Angelo - U.O.C. Cardiologia city: Mestre state: VE zip: 30171 country: Italy lat: 45.49167 lon: 12.24538 facility: Presidio Ospedaliero Di Mirano - U.O.C. Di Cardiologia city: Mirano state: VE zip: 30035 country: Italy lat: 45.49458 lon: 12.10775 facility: Ospedale Civile - U.O.C. Di Cardiologia city: San Dona' Di Piave state: VE zip: 30027 country: Italy lat: 45.63019 lon: 12.5681 facility: Ospedale Civile - U.O.C. Di Cardiologia city: Arzignano state: VI zip: 36071 country: Italy lat: 45.52027 lon: 11.33446 facility: Ospedale Civile San Bortolo - U.O.C. Cardiologia city: Vicenza state: VI zip: 36100 country: Italy lat: 45.54672 lon: 11.5475 facility: Ospedale G. Fracastoro - U.O.C. Di Cardiologia city: San Bonifacio state: VR zip: 37047 country: Italy lat: 45.39595 lon: 11.27352 facility: Aoui Di Verona - U.O. Cardiologia city: Verona state: VR zip: 37126 country: Italy lat: 45.4299 lon: 10.98444 facility: Ospedale Belcolle - Uosd Utic Polo city: Viterbo state: VT zip: 01100 country: Italy lat: 42.41937 lon: 12.1056 facility: Ospedale Ss. Trinita' - S.C. Di Cardiologia city: Borgomanero zip: 28021 country: Italy lat: 45.69873 lon: 8.4623 facility: Ospedale Civile Di Boscotrecase - Utic Cardiologia city: Boscotrecase zip: 80042 country: Italy lat: 40.77296 lon: 14.46185 facility: Ospedale San Leonardo - U.O. Di Cardiologia-Utic city: Castellammare Di Stabia zip: 80053 country: Italy lat: 40.70211 lon: 14.48685 facility: Ospedale San Giovanni Di Dio - Uo Cardiologia - Utic city: Frattamaggiore zip: 80027 country: Italy lat: 40.9414 lon: 14.27588 facility: Presidio Ospedaliero San Giugliano - U.O. Cardiologia - Utic city: Giugliano in Campania zip: 80014 country: Italy lat: 40.92849 lon: 14.20197 facility: Ospedale Civile - S.C. Cardiologia city: Ivrea zip: 10015 country: Italy lat: 45.46723 lon: 7.87617 facility: Ospedale Anna Rizzoli - Cardiologia-Utic city: Lacco Ameno zip: 80076 country: Italy lat: 40.74901 lon: 13.88718 facility: Aorn Cardarelli - U.O. Cardiologia Con Utic city: Napoli zip: 80131 country: Italy lat: 40.85216 lon: 14.26811 facility: Aorn Ospedale Dei Colli - P.O. Monaldi - Uoc Cardiologia-Utic city: Napoli zip: 80131 country: Italy lat: 40.85216 lon: 14.26811 facility: Ospedale Dei Pellegrini - Uoc Cardiologia-Utic city: Napoli zip: 80134 country: Italy lat: 40.85216 lon: 14.26811 facility: Ospedale Del Mare - U.O. Cardiologia Con Utic-Emodinamica city: Napoli zip: 80147 country: Italy lat: 40.85216 lon: 14.26811 facility: Pres. Ospedaliero S. Maria Della Pieta' - U.O. Cardiologia E Utic city: Nola zip: 80035 country: Italy lat: 40.92606 lon: 14.52816 facility: Aou Maggiore Della Carita' - Scdo Cardiologia Ii city: Novara zip: 28100 country: Italy lat: 45.44694 lon: 8.62118 facility: Ospedale Santa Maria Delle Grazie - U.O. Cardiologia - Utic Con Emodinamica city: Pozzuoli zip: 80078 country: Italy lat: 40.84394 lon: 14.0952 hasResults: False

 nctId: NCT06316115 id: HRRU-KMY-FA-01 briefTitle: Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement overallStatus: RECRUITING date: 2023-12-12 date: 2024-03-10 date: 2024-04-10 date: 2024-03-18 date: 2024-03-18 name: Harran University class: OTHER briefSummary: Diabetic foot ulcer; It is a disease used to describe a series of lower extremity complications that may occur together with infection, ulceration or gangrene in individuals with diabetes and is coded as S91.3 and S91.8 in the International Classification of Diseases (ICD). Sharp debridement, one of the treatments for diabetic foot ulcers, is a short-term application performed with a sharp scalpel or scissors at the patient's bed or in outpatient clinic conditions. It should be performed by a skilled clinician with wound training. To our knowledge, no study has been found in the literature regarding the use of a stress ball as an intervention to prevent pain and anxiety during sharp debridement. In line with this information, this study will examine the effect of stress ball use on the pain and anxiety levels of patients with diabetic foot ulcers during wound debridement. conditions: Diabetic Foot Ulcer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 76 type: ESTIMATED name: In Patıents Wıth Dıabetıc Foot Ulcer, Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement measure: Introductory Information Form measure: Meggit-Wagner classification of diabetic foot measure: Visual Comparison Scale measure: State Anxiety scale (STAI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Harran Universitesi status: RECRUITING city: Şanlıurfa country: Turkey name: Fatma ASLAN role: CONTACT phone: +905427760715 email: fatmaaslan62@gmail.com lat: 37.16708 lon: 38.79392 hasResults: False

 nctId: NCT06316102 id: 22-3282 briefTitle: Promoting Viral Suppression Among Transgender Women Living With HIV in Santo Domingo overallStatus: ACTIVE_NOT_RECRUITING date: 2023-07-14 date: 2025-01-01 date: 2025-01-01 date: 2024-03-18 date: 2024-03-28 name: University of North Carolina, Chapel Hill class: OTHER name: Instituto Dermatológico y Cirugía de Piel (IDCP) name: George Washington University briefSummary: This study includes an adapted multilevel intervention, Abriendo Puertas (Opening Doors), including individual counseling, peer navigation, and community mobilization for transfeminine people living with HIV in the Dominican Republic using an iterative consultation process. Prior to this randomized controlled trial, feasibility and initial effects on HIV care and treatment behaviors were assessed with 30 trans women living with HIV (no control group) and documented positive trends in antiretroviral therapy use (70% to 85%, p=0.03), missed care appointments (35% to 20%, p=0.39) and antiretroviral therapy adherence (86% to 96%, p=0.50). Participants emphasized that trusting intervention staff and being treated with respect in individual sessions allowed them to improve self-esteem. Limited trust and cohesion among trans women, however, inhibited more extensive engagement with peer navigation and community activities. In response, the study team identified two key modifications to strengthen and further tailor the intervention for transfeminine people living with HIV: 1) integrate more gender affirming content, including with providers and 2) focus on building trust among transfeminine people through sequential implementation of individual and then community components. The purpose of the proposed study is to conduct a pilot randomized trial of the Gender-affirming Abriendo Puertas intervention. In Aim 1, the preliminary efficacy of the Gender-affirming Abriendo Puertas intervention on viral suppression among transfeminine people randomized to the intervention compared to those randomized to control will be assessed. The research study will randomly assign transfeminine people living with HIV to the Gender-affirming Abriendo Puertas intervention (n=60) (individual counseling, peer navigation, provider training, and community support building) or control group (n=60). There will be baseline, 6, and 12-month surveys and viral load assessments to assess differences across study arms. In Aim 2, the study team will examine pathways of influence (e.g. decreased stigma, increased cohesion) and experiences with the intervention to identify specific areas for improvement and scale up. Longitudinal qualitative interviews will be conducted at baseline, 6, and 12 months with 20 intervention participants. Together with surveys, the study team will assess how Gender-affirming Abriendo Puertas participation affects pathways between stigma, cohesion, and HIV outcomes. The study team will also elicit experiences and recommendations from providers and intervention staff in focus groups at 6 (n=2) and 12 months (n=2). conditions: HIV studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 121 type: ACTUAL name: Gender Affirming Abriendo Puertas (Opening Doors) (GAP) measure: Viral Suppression (HIV), 6 months measure: Viral Suppression (HIV), 1 year measure: Retention in HIV care, 6 months measure: Retention in HIV care, 1 year measure: Antiretroviral therapy adherence, 6 months measure: Antiretroviral therapy adherence, 1 year measure: Antiretroviral therapy interruption, 6 months measure: Antiretroviral therapy interruption, 1 year measure: Depression, 6 months measure: Depression, 1 year measure: Anxiety, 6 months measure: Anxiety, 1 year measure: Substance use, 6 months measure: Substance use, 1 year measure: Binge drinking, 6 months measure: Binge drinking, 1 year measure: Self-esteem, 6 months measure: Self-esteem, 1 year sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto Dermatológico y Cirugía de Piel (IDCP) city: Santo Domingo country: Dominican Republic lat: 18.50012 lon: -69.98857 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-03-21 uploadDate: 2024-03-22T10:41 filename: SAP_000.pdf size: 86302 hasResults: False

 nctId: NCT06316089 id: K23DA054003 type: NIH link: https://reporter.nih.gov/quickSearch/K23DA054003 briefTitle: An Intervention to Improve HIV Pre-exposure Prophylaxis Initiation, Adherence and Linkage to Care for Recently Incarcerated Men Who Inject Drugs. overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2027-01 date: 2027-06 date: 2024-03-18 date: 2024-03-18 name: Rhode Island Hospital class: OTHER briefSummary: Pre-exposure prophylaxis (PrEP) is effective in preventing HIV infection among people who inject drugs (PWID) yet studies suggest that its use is low among this population which is particularly vulnerable to HIV infection. The criminal justice (CJ) system, at the intersection of increased risk of HIV infection and substance use, presents a unique opportunity to engage PWID in HIV prevention care that incudes PrEP. The study will characterize the facilitators and barriers to PrEP initiation, adherence and linkage to care among male PWID that are experiencing incarceration and develop the "PrEPare-for-Release" intervention to promote PrEP initiation, adherence and linkage to care upon release from incarceration into the community. conditions: Hiv conditions: Substance Use Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: PrEPared for Release measure: PrEP initiation measure: Adherence to PrEP measure: Linkage to PrEP care in the community sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06316076 id: RJMty19-AID001 briefTitle: Safety and Efficacy Study of CD19-CAR-DNT Cells in Autoimmune Diseases overallStatus: RECRUITING date: 2023-10-30 date: 2024-06 date: 2026-06 date: 2024-03-18 date: 2024-03-18 name: RenJi Hospital class: OTHER name: Guangdong Ruishun Biotech Co., Ltd briefSummary: To evaluate the safety and efficacy of CD19-CAR-DNT cells in subjects with relapsed/refractory autoimmune diseases conditions: Systemic Lupus Erythematosus conditions: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis conditions: Idiopathic Inflammatory Myopathies conditions: Systemic Sclerosis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: CD19-CAR-DNT cells measure: DLT measure: MTD measure: Incidence of abnormalities measure: Pharmacokinetics (PK) indicator (Cmax) measure: Pharmacokinetics (PK) indicator (AUC) measure: Pharmacokinetics (PK) indicator (Tmax) measure: Pharmacokinetics (PK) indicator (T1/2) measure: Disease response rate at 6 months measure: Duration of Response sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Rheumatology, Ren Ji Hospital South Campus, School of Medicine, Shanghai JiaoTong University status: RECRUITING city: Shanghai country: China name: Qiong Fu, MD, PhD role: CONTACT phone: 86-13585603288 email: fuqiong@renji.com name: Shuang Ye, MD, PhD role: CONTACT phone: 86-15801706421 email: Yeshuang@renji.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06316063 id: 2023- briefTitle: Hemodynamic Effects of Apnoeic Oxygenation With High-flow Nasal Oxygen in Adults Undergoing Laryngeal Surgery - a Randomised Study acronym: CAPOX overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2026-03-25 date: 2026-03-25 date: 2024-03-18 date: 2024-03-18 name: Region Stockholm class: OTHER_GOV name: Karolinska Institutet briefSummary: During apnoeic oxygenation there is a continuous raise in carbon dioxide with subsequent respiratory acidosis. The hypercapnia and respiratory acidosis have several dose-related effects on both the systemic and the pulmonary circulation and the heart that ultimately, if unrecognised, can result in cardiovascular collapse and fatal arrhythmias. In our knowledge, no studies have investigated the haemodynamic effects of apnoeic oxygenation with HFNO.

The general purpose of this project is to investigate haemodynamic alternations during apnoeic oxygenation with HFNO compared to mechanical ventilation in relatively healthy patients under general anaesthesia during laryngeal surgery. conditions: Laryngeal Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ESTIMATED name: Apnoeic oxygenation with high-flow nasal oxygen name: Mechanical ventilation measure: Significant haemodynamic effects during apnoeic oxygenation with HFNO measure: Alterations in FloTrac derived central haemodynamic parameters measure: Alterations in Electrocardiogram measure: Alterations in arterial carbon dioxide, oxygen and pH measure: Alterations in blood catecholamines and cardiac biomarkers sex: ALL minimumAge: 18 Years maximumAge: 110 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06316050 id: cst briefTitle: Retrovertion Assesment and Study in Elderly Patients With Reverse Total Shoulder Arthroplasty overallStatus: COMPLETED date: 2018-08-01 date: 2021-08-31 date: 2023-06-28 date: 2024-03-18 date: 2024-03-18 name: Consorci Sanitari de Terrassa class: OTHER briefSummary: Determine the optimal degree of retroversion (0-30º) to obtain the best rotational mobility, both internal and external, of the shoulder after implanting a reversed sghoulder arthroplasty (Comprehensive system), and analyze the functional and radiologic results based on humeral retroversion. conditions: Rotator Cuff Tears conditions: Rotator Cuff Tear Arthropathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Open randomized controlled clinical trial. whoMasked: PARTICIPANT count: 60 type: ACTUAL name: humeral retroversion measure: INTERNAL ROTATION measure: INTERNAL ROTATION measure: EXTERNAL ROTATION measure: FORWARD ELEVATION measure: Simple shoulder test measure: Constant test measure: ASES test measure: Glenoid inclination angle measure: glenoid retroversion angle measure: abduction measure: center of rotation measure: lateralizaiton offset sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: JM MORA city: Terrassa state: Barcelona zip: 08227 country: Spain lat: 41.56667 lon: 2.01667 hasResults: False

 nctId: NCT06316037 id: 2024 DUTHEIL ADAPTAWORK_2 briefTitle: Adaptation of Work in a Hospital and Assessment of Feelings of Quality of Life at Work, Teleworking and Face-to-face acronym: ADAPTAWORK_2 overallStatus: COMPLETED date: 2023-09-12 date: 2024-01-20 date: 2024-01-20 date: 2024-03-18 date: 2024-03-18 name: University Hospital, Clermont-Ferrand class: OTHER briefSummary: The ADAPTAWORK_2 study is a follow-up to the first qualitative study, to evaluate the feelings of hospital workers in all occupations about teleworking. This involves measuring the variation between three periods: before the COVID-19 pandemic, during the first lockdown an after the pandemic.

Secondary objectives were: 1) to evaluate wich factors were associated to the feelings towards teleworking, 2) to assess musculo-squeletal disorders among teleworkers and the other participants, 3) to assess psycho-social risks among teleworkers and the oher participants, and 4) to evaluate teleworking costs conditions: Work-Related Stress conditions: Work-Related Condition studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 945 type: ACTUAL measure: Feeling about teleworking measure: Musculo-squeletic pain measure: psychosocial risks measure: purchases sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Clermont-Ferrand city: Clermont-Ferrand country: France lat: 45.77966 lon: 3.08628 hasResults: False

 nctId: NCT06316024 id: IRB2023056 briefTitle: Early Oral Intake of Different Types of Diets Affecting Gastrointestinal Function overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-03-18 date: 2024-03-18 name: Chiayi Christian Hospital class: OTHER briefSummary: The percentage of cesarean deliveries is on the rise, accounting for 30-40% of all deliveries in Taiwan. Following a cesarean delivery, a few doctors in Taiwan still adheres to the progressive eating regimen of "nothing per mouth" for 24 hours or until the patient passes flatus or hears bowel sounds. However, a meta-analysis has shown that early oral intake (6-8 hours) significantly reduces the time required for the restoration of gastrointestinal function and hospital stay compared to delayed oral intake. Furthermore, early oral intake has not shown to increase the likelihood of gastrointestinal complications. While several food types have been adopted for early oral intake, no study has investigated the effect of different food types on clinical outcomes regarding gastrointestinal function and hospital stay for cesarean delivery. Therefore, the objective of this study is to investigate the effect of different food types on clinical outcomes for cesarean delivery through a randomized controlled trial. The subjects of this study are pregnant women who come to Chiayi Christian Hospital to schedule cesarean deliveries. They are randomly assigned to one of four groups: nothing by mouth, water, juice/sports drink, or chewing gum. The relevant clinical outcomes, such as time to first bowel sound or readiness for discharge, are recorded. One-way analysis of variance or Chi-square test is used to compare the differences among the four groups. Our expected results could provide valuable information on the type of food that could be used to improve the recovery of mothers after cesarean delivery and increase the quality of breastfeeding. conditions: Cesarean Section studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: water name: juice/sport drink group name: Chewing gum group measure: first time to bowel sound measure: beginning of breastmilk lactation measure: length of hospital stay measure: time to first drink measure: time to first solid food intake measure: duration of IV hydration measure: IV cannulae removal measure: first ambulation measure: first stool measure: satisfaction VAS (0-100) regarding the early intake sex: FEMALE minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06316011 id: MCG-chestpain briefTitle: MCG for Risk Stratifications of Patients With Chest Pain overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-04-30 date: 2024-08-31 date: 2024-03-18 date: 2024-03-18 name: Qilu Hospital of Shandong University class: OTHER briefSummary: This prospective cohort study is aimed at identification and risk stratification of patients who have symptoms of acute chest pain suspected with acute coronary syndrome （ACS） using Magnetocardiography （MCG）. conditions: Acute Coronary Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3620 type: ESTIMATED name: Magnetocardiography measure: Efficacy of MCG for the detection and risk stratification in patients with chest pain sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06315998 id: MCG-Structural briefTitle: Diagnosis of Structural Heart Disease Using MCG overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2025-04-30 date: 2025-09-30 date: 2024-03-18 date: 2024-03-18 name: Qilu Hospital of Shandong University class: OTHER briefSummary: The purpose of this prospective cohort study is to determine the parameters of cardiac magnetic imaging to identify structural heart disease using use transthoracic echocardiography or cardiac magnetic resonance as reference standard. conditions: Structural Heart Abnormality studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2914 type: ESTIMATED name: Magnetocardiography measure: The efficacy of the MCG in identifying structural heart disease sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06315985 id: GAksoy briefTitle: Classical Turkish Music for Pregnant Women With Preeclampsia overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-09-20 date: 2025-03-20 date: 2024-03-18 date: 2024-03-20 name: Tarsus University class: OTHER briefSummary: Stress and Sleep of Classical Turkish Music in Pregnant Women Diagnosed with Preeclampsia in Clinics The study to be carried out to determine the effect on quality is a randomized controlled experimental research. All patients who comply with the limitations of the study and volunteer will be included in the study. When the studies in the literature are examined, there are a limited number of studies on the effects of music on pregnant women diagnosed with preeclampsia, and no studies have been found on the effects of music on stress and sleep quality in pregnant women with preeclampsia. This research aimed to determine the effect of Classical Turkish Music on stress and sleep quality in pregnant women diagnosed with Preeclampsia in clinics. conditions: Pre-Eclampsia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This was a parallel group, randomized controlled trial conducted in a tertiary hospital in Mersin city center, Turkey. In parallel with the purpose of the study, participants were selected from the pregnant women diagnosed with preeclampsia who were hospitalized at Mersin City Training and Research Hospital.The population of the research is the G\* Power 3.1.9.4 was determined by analysis using. In the analysis, the sample size was taken as a sample size of at least 80%, a medium effect size (0.5) and a two-way type 1 error value of 0.05, since no study similar to the study could be found, and a total of 128 pregnant women were included in the two groups (in each group) to determine the difference between the averages of two independent groups. It was calculated as 64 pregnant women). Considering the drop out rate of 10% during the research, the total number of samples was found to be 142 (experimental group: n=71, control group: n=71) pregnant women. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Participant will be masking. whoMasked: PARTICIPANT count: 142 type: ESTIMATED name: Experimental group: Listenning to the Turkish Classical Music to pregnant women diagnosed with preeclampsia measure: Perceived Stress measure: Sleep Quality sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Gülay Aksoy city: Mersin zip: 33080 country: Turkey name: Gülay Aksoy role: CONTACT phone: +905518627438 email: 220931003@tarsus.edu.tr name: Eylem Toker role: CONTACT email: eylemtoker@tarsus.edu.tr lat: 36.79526 lon: 34.61792 hasResults: False

 nctId: NCT06315972 id: 2022-000054-28 briefTitle: Combining Clemastine and Aerobic Exercise to Treat Cognitive Dysfunction in Schizophrenia by Targeting Myelin Plasticity acronym: OligoTreat overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-11 date: 2028-04 date: 2024-03-18 date: 2024-03-20 name: LMU Klinikum class: OTHER briefSummary: Schizophrenia (SZ) is a broad clinical entity characterized by different subjective symptoms,behavioural signs, and disease course. Research has pointed to numerous biological indicators tentatively associated with neurocognitive dysfunction, brain structural and neurochemical alterations. Cognitive deficits occur as early as the prodromal phase of the illness and significantly determine its outcome. Pathophysiologically, SZ is regarded as a disconnectome disorder in which frontal and temporal brain regions are functionally disconnected, which contributes substantially to the development of cognitive dysfunction.

Impaired connectivity is related to synaptic (microconnectivity) and myelin (macroconnectivity) plasticity. With design-based stereology, a decreased number of oligodendrocytes (OLs) in the CA4 hippocampal subregion as the basis for disturbed myelination and impaired cognition, but also a decrease in the prefrontal cortex were observed. Animal studies demonstrated that clemastine enhances remyelination by increasing the differentiation of oligodendrocyte precursor cells (OPCs) and showed that aerobic exercise increases the rate of remyelination and proliferation of OPCs; this clinically meaningful effect of aerobic exercise is stronger in combination with clemastine. Furthermore, aerobic exercise improves everyday functioning, measured by the Global Assessment of Functioning (GAF) scale, and cognitive dysfunction in SZ and increases hippocampal volume, especially the volume in the hippocampal CA4 subregion. This regional volume change correlates negatively with global and cell-specific polygenic risk scores (PRSs), indicating that OPCs are involved in the genetic risk mechanisms and disturbed plasticity underlying SZ. In patients with multiple sclerosis, 90 days' administration of clemastine fumarate 10.72 mg/day, corresponding to clemastine 8 mg/day, significantly decreased the P100 latency delay of visual evoked potentials (VEPs) as a sign of myelin repair. In a bicentric, randomized, double-blind, controlled phase IIb clinical trial with a 2-arm parallel group design in patients with SZ, the study will compare the effects of aerobic exercise training plus clemastine vs. aerobic exercise training plus placebo over a period of 3 months on 1) everyday functioning and 2) working memory as primary outcomes. conditions: Schizophrenia studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: clemastine (8 mg/day) name: Placebo measure: change in Global Assessment of Functioning measure: change in working memory performance sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06315959 id: ESPCHRONIC2023 briefTitle: Bilateral Erector Spinae Plane Block for Postoperative Chronic Pain After Open Heart Surgery overallStatus: RECRUITING date: 2024-04-01 date: 2025-01-15 date: 2025-03-15 date: 2024-03-18 date: 2024-04-02 name: Ondokuz Mayıs University class: OTHER briefSummary: The aim of this study is to investigate the effect of bilateral erector spinae plane (ESP) block application on postoperative chronic pain in patients undergoing on-pump open-heart surgery. At 3 months post-discharge, patients will be contacted by phone to assess their chronic pain status. Pain intensity and status will be evaluated using the Brief Pain Inventory, and the character of pain will be assessed using the Douleur Neuropathique 4 (DN4) score. Additionally, the patient's anxiety and depression status will be evaluated using the Hospital Anxiety and Depression Scale. conditions: Chronic Pain conditions: Cardiac Surgery conditions: Post Operative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer (Urbaniak and Plous, 2013)'. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Sealed opaque envelopes containing study participation numbers will be used to assign each patient. A researcher not involved in patient follow-up will use the web-based "Research Randomizer" (Urbaniak and Plous 2013) tool to give each participation number to a random group with a 1:1 ratio. A nurse not an active investigator in the study will have each participant choose an envelope containing the study participation number. They will inform the anesthetist administering the block/blocks about which group the patient is in immediately before administration. Researchers, surgeons, and nurses will not be aware of the randomization of groups. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Bilateral ultrasound guided erector spinae plane block name: morphine PCA name: Control group name: morphine PCA measure: Chronic pain status measure: Postoperative opioid consumption in the first 24 Hours measure: Postoperative pain scores measure: The incidences of post-operative nausea and vomiting (PONV) measure: The number of patient requiring rescue analgesic measure: Time to extubation measure: The number of patients with complications measure: Chronic pain status at 6 months. measure: Length of stay in the ICU sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ondokuz Mayis University status: RECRUITING city: Samsun state: Atakum zip: 55139 country: Turkey name: BURHAN DOST role: CONTACT phone: 05327042493 email: burhandost@hotmail.com lat: 41.27976 lon: 36.3361 hasResults: False

 nctId: NCT06315946 id: 17E3241 briefTitle: Efficacy of a Cryogenic Medical Device on Skin Tags Versus a Comparator Product. overallStatus: COMPLETED date: 2018-10-04 date: 2019-01-07 date: 2019-03-11 date: 2024-03-18 date: 2024-03-18 name: Oystershell NV class: INDUSTRY briefSummary: Evaluate the efficacy of the test medical device (Pixie® skin tag) in the treatment of skin tags versus a comparator product (Wortie® skin tag remover). conditions: Skin Tags studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 56 type: ACTUAL name: Pixie® skin tag name: Wortie® Skin Tag Remover measure: Percentage of subjects with successful treatment measure: Number of treatments measure: Visual aspect measure: Macrophotographs on skin tag remission measure: Evaluation of the skin condition measure: Degree of pain measure: Recording of adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: DERMSCAN - PharmScan city: Villeurbanne zip: 69100 country: France lat: 45.76667 lon: 4.88333 hasResults: False

 nctId: NCT06315933 id: S-K1093 briefTitle: Anesthesia Neurodevelopmental Impact in Congenital Scoliosis Children overallStatus: RECRUITING date: 2020-01-13 date: 2025-12 date: 2026-12 date: 2024-03-18 date: 2024-03-18 name: Peking Union Medical College Hospital class: OTHER briefSummary: In the past, a large number of animal studies have suggested that anesthesia exposure has potential neurotoxic effects, resulting in persistent cognitive and behavioral deficits. At present, there is still a lack of sufficient clinical research evidence to prove whether anesthesia exposure has long-term effects on neurodevelopment. The existing clinical research data suggests that a single short-time anesthesia exposure in young children does not affect long-term neurodevelopmental outcomes. Early onset scoliosis, including congenital scoliosis, is a type of scoliosis deformity that occurs before the age of 10. Posterior scoliosis correction surgery is one of the common treatment. There is currently no research indicating the impact of early single or multiple long-duration anesthesia exposure on the neurological development of children with congenital scoliosis. The aim of this study is to determine the long-term effect of general anesthesia exposure on neurocognitive function and behavior in children with congenital scoliosis, in order to provide reference for related clinical work. conditions: General Anesthetics Toxicity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 80 type: ESTIMATED name: General anesthesia measure: full-scale intelligence quotient, FSIQ measure: Verbal Comprehension Index (VCI), Perceptual Reasoning/Organization Index (PRI/POI), Working Memory Index (WMI), Processing Speed Index (PSI) measure: CBCL Total score, CBCL Internalizing score, CBCL Externalizing score measure: SDQ Emotional symptoms, SDQ conduct problems, SDQ hyperactivity, SDQ peer problems, SDQ total difficulties, SDQ prosocial behaviors, SDQ impact factor sex: ALL minimumAge: 6 Years maximumAge: 16 Years stdAges: CHILD facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Lulu Ma, Dr. role: CONTACT phone: 0086-010-13811049619 email: malulu@pumch.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06315920 id: AFMS-MREC 009/2021 briefTitle: Analgesic Effect of Parecoxib Versus Morphine in SCD Patients Presenting to the Emergency Department acronym: PASC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-07-01 date: 2024-03-18 date: 2024-03-18 name: Oman Medical Speciality Board class: OTHER_GOV name: Armed Forces Hospital, Oman briefSummary: Introduction: This study focuses on the treatment of painful crises in Sickle Cell Disease (SCD) patients using Paracoxib, a non-opioid, compared to Morphine. It addresses the need for alternative medications that reduce opioid dependency while providing effective analgesia.

Objectives:

Primary: Evaluate the analgesic effect of Paracoxib versus Morphine in SCD vaso-occlusive crises.

Secondary: Reduce opioid use/dependence, decrease the length of hospital stays, and monitor side effects related to Paracoxib.

Methodology: A double-blinded randomized controlled trial, conducted in a tertiary care emergency department. The study includes adult SCD patients with moderate to severe crises, excluding non-VOC pain, certain medications, and specific medical conditions. The sample size is 226 patients, split equally into two groups.

Intervention: Patients receive either Morphine or Paracoxib, with periodic assessment of vital signs and pain. Additional Morphine is administered if required. Data collection and analysis are meticulously planned.

Expected Outcomes: Improvement in SCD pain management, reduction in opioid usage, and potential benefits in terms of hospital stays and patient satisfaction. conditions: Sickle-Cell Disease With Crisis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The masking process involves the following steps:

Preparation of Medication: A nurse, who is not involved in the direct care or assessment of the patients, will prepare the medications. This nurse is the only individual aware of the specific treatment being administered to each patient. The medications are prepared in a manner that makes them indistinguishable from each other in appearance, labeling, and administration method.

Administration of Medication: The medications are then administered to the patients by healthcare providers who are blinded to the nature of the medication. This ensures that their assessment of the patient's response is not influenced by knowledge of the treatment being given.

Assessment and Data Collection: The assessment of pain relief, side effects, and other relevant clinical outcomes is conducted by healthcare providers who are blinded to the treatment allocation. This minimizes bias in the evaluation of the treatment's efficacy and safety. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 226 type: ESTIMATED name: Parecoxib name: Morphine measure: Pain reduction at 60 mins. measure: Adverse Events/Side Effects measure: The need of rescue pain medications measure: Recurrent visit sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06315907 id: PBRC 2024-012 briefTitle: Development and Validation of a Brief Food Noise Questionnaire overallStatus: ENROLLING_BY_INVITATION date: 2024-04-25 date: 2024-05-24 date: 2024-05-28 date: 2024-03-18 date: 2024-04-26 name: Pennington Biomedical Research Center class: OTHER name: Weight Watchers International briefSummary: The purpose of the research is to develop and test the reliability and validity of a brief questionnaire to measure food noise. conditions: Eating Behavior studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED name: Responses to survey questions measure: Scores on the food noise questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pennington Biomedical Research Center city: Baton Rouge state: Louisiana zip: 70806 country: United States lat: 30.45075 lon: -91.15455 hasResults: False

 nctId: NCT06315894 id: PI-22-191 briefTitle: Supervised Computerized Active Program for People With Post-COVID Syndrome (SuperCAP Study) acronym: SuperCAP overallStatus: RECRUITING date: 2023-10-03 date: 2024-10 date: 2025-09 date: 2024-03-18 date: 2024-03-18 name: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia class: OTHER name: Institut de Recerca de la SIDA IrsiCaixa name: Germans Trias i Pujol Hospital briefSummary: SuperCAP study is a project aimed at designing and implementing an online program for improvement of cognitive, emotional, and functional status in post-COVID condition. conditions: Post-COVID Condition studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: SuperCAP Program measure: Change in Self-reported Cognitive Functioning measure: Change in Performance-based Cognitive Functioning measure: Change in Depression Symptoms measure: Change in Anxiety Symptoms measure: Change in Daily Activities Functioning measure: Change in Physical Activity measure: Change in Quality of Life sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Germans Trias I Pujol Hospital status: RECRUITING city: Badalona state: Barcelona zip: 08916 country: Spain name: Jose A MUñoz-Moreno, MD,PhD role: CONTACT phone: 93 465 7897 email: jmuñoz@lluita.org name: Jose A. Muñoz-Moreno, MD,PhD role: PRINCIPAL_INVESTIGATOR lat: 41.45004 lon: 2.24741 hasResults: False

 nctId: NCT06315881 id: OSU-23116 id: NCI-2024-00666 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: U54CA287392 type: NIH link: https://reporter.nih.gov/quickSearch/U54CA287392 briefTitle: Informing Oral Nicotine Pouch Regulations to Promote Public Health overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-18 date: 2024-03-18 name: Ohio State University Comprehensive Cancer Center class: OTHER name: National Cancer Institute (NCI) briefSummary: This clinical trial evaluates the characteristics of oral nicotine pouches (ONPs) to determine if they are a comparable substitute to cigarette or smokeless tobacco (ST) products. ONPs contain nicotine but no tobacco and are used primarily by adult tobacco uses in the United States (US). ONPs are recognized by the Food and Drug Administration as having lower risk than combustible cigarettes and are approved as a modified risk tobacco product. While ONPs have lower toxic risk than other tobacco products, acute and longer term harm related to their use has not been studied. Information gathered from this study may identify product characteristics of ONPs that improve successful switching from high-risk cigarettes or ST to lower risk ONPs. conditions: Tobacco-Related Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 160 type: ESTIMATED name: Biospecimen Collection name: Cigarette name: Nicotine Oral Pouch name: Nicotine Oral Pouch name: Nicotine Oral Pouch name: Nicotine Oral Pouch name: Smokeless Tobacco name: Survey Administration name: Text Message-Based Navigation Intervention measure: Increased nicotine delivery measure: Liking measure: Craving/withdrawal suppression measure: Rate of switching to ONP measure: Rate of switching to ONPs sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio State University Comprehensive Cancer Center city: Columbus state: Ohio zip: 43210 country: United States name: Brittney L. Keller-Hamilton, PhD, MPH role: CONTACT phone: 614-366-9652 name: Brittney L. Keller-Hamilton, PhD, MPH role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06315868 id: 5590 briefTitle: Breast Cancer Subtype Characterization Through Patient's Derived Organoids. acronym: BCinsightPDO overallStatus: RECRUITING date: 2023-06-15 date: 2026-06-15 date: 2027-06-15 date: 2024-03-18 date: 2024-03-18 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Development of tools to predict patients chemo-sensitivity and identification of corresponding biomarkers is an urgent challenge for BC patients lacking targeted therapies, such as TNBC, or for patients experiencing relapse after adjuvant chemotherapy or targeted therapies.

The refinement of 3D-cultivation techniques, experienced in the last decade, has allowed cultivation of patients-derived cancer cells in organotypic structures, named patient-derived organoids (PDO), which preserve histologic, genomic and transcriptomic features of primary tumors. PDO allow propagation, pharmacological treatment and genetic manipulation of patients-derived cancer cells in a close to physiology setting, thus representing a promising tool in the development of personalized therapies conditions: Breast Cancer conditions: Organoids studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 306 type: ESTIMATED measure: evaluate the histological and molecular conformity (yes/no) between PDO and matched primary and/or recurrent BC sample, in order to develop a live biobank of ER/PR+, HER2+ and TNBC PDO. measure: evaluate the sensitivity of ER/PR+, HER2+ and TNBC PDO to novel therapeutic agents in clinical trials for BC or other cancer types measure: test the sensitivity of PDO to splicing-targeting treatments, either alone or in combination with other therapies measure: test the synergizing effects of agents splicing-targeting treatments to immunotherapies by co-culture experiments with autologous immune cells sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Fondazione Policlinico A. Gemelli status: RECRUITING city: Roma zip: 00168 country: Italy name: alba di leone, MD role: CONTACT phone: 0039 3474980503 email: alba.dileone@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06315855 id: STUDY00006928 briefTitle: Leveraging Telehealth to Improve Oral Health Among Cancer Survivors overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2025-03-25 date: 2025-12-25 date: 2024-03-18 date: 2024-03-18 name: Georgetown University class: OTHER briefSummary: The investigators will conduct a 2-arm 6-month randomized clinical controlled trial to evaluate the effectiveness of an oral Telehealth Intervention (THI) in preventing cancer-related oral complications, improving oral health maintenance and oral health related quality of life, and reducing systemic inflammation compared to Usual Care (UC) among unselected cancer survivors. conditions: Oral Mucositis conditions: Periodontal Diseases conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: Telehealth Intervention (THI) measure: mucositis measure: gingival inflammation and periodontal disease measure: tooth decay measure: oral health related quality of life measure: systemic inflammation measure: overall health related quality of life measure: comorbidities sex: ALL minimumAge: 25 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06315842 id: CSAPG-44 briefTitle: Levels of Diagnostic and Therapeutic Intervention in Hospitalized Patients acronym: NIT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-07 date: 2025-07 date: 2024-03-18 date: 2024-03-18 name: Consorci Sanitari de l'Alt Penedès i Garraf class: OTHER briefSummary: The objective of this clinical trial is to investigate the impact of implementing a tool for adjusting the level of diagnostic and therapeutic intensity in the clinical practice of physicians attending hospitalized patients.

The goal of this clinical trial is to investigate the impact of a tool for adjusting diagnostic and therapeutic intensity in hospitalized patients. The main question it aims to answer is: Is there a difference in patient mortality when using the aforementioned tool? The participating physicians will be grouped into 4 groups (5 physicians each). Each group will progressively (every 3 months) incorporate the use of the aforementioned tool into their usual clinical practice. conditions: Acute Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The participating physicians will be grouped into 4 clusters (5 physicians each). Each cluster will progressively (every 3 months) incorporate the use of a level of diagnostic and therapeutic intensity tool into their usual clinical practice. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Levels of Diagnostic and Therapeutic Intervention tool by Fontecha and col. name: Usual clinical practice measure: In-hospital Patient Mortality at 90 days from hospital discharge measure: In-hospital Patient Mortality at 6 months from hospital discharge measure: In-hospital Patient Mortality at 1 year from hospital discharge measure: Delirium Incidence measure: Pressure Ulcer Incidence measure: Hospital stay measure: Hospital readmission for any reason measure: Hospital readmission for same reason measure: Patients admitted to the Intensive Care Unit (ICU) measure: Calls to the "on-call doctor" measure: Healthcare expenditure measure: Mortality at ICU sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Consorci Sanitari Alt Penedes i Garraf city: Vilafranca Del Penedès state: Barcelona zip: 08720 country: Spain name: Helena Camell role: CONTACT phone: +34 938960025 phoneExt: 46048 email: hcamell@csapg.cat name: Noemí Casaponsa role: CONTACT phone: +34 938960025 phoneExt: 43197 email: recerca@csapg.cat lat: 41.34618 lon: 1.69713 hasResults: False

 nctId: NCT06315829 id: IRB00429753 briefTitle: Artificial Intelligence-based Video Analysis to Detect Infantile Spasms overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-05 date: 2024-03-18 date: 2024-03-18 name: Johns Hopkins University class: OTHER briefSummary: Infantile spasms are a type of seizure linked to developmental issues. Unfortunately, they are often misdiagnosed, causing delays in treatment. The purpose of this study is to develop a computer program that can reliably differentiate infantile spasms from similar, yet benign movements in videos. This computer program will learn from videos taken by parents of study participants. Quickly recognizing and treating infantile spasms is crucial for ensuring the best developmental outcomes. conditions: Infantile Spasms studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Spasm Vision measure: Model Sensitivity (Recall) measure: Model Specificity measure: Model Positive Predictive Value (Precision) measure: Model Negative Predictive Value sex: ALL maximumAge: 2 Years stdAges: CHILD facility: Johns Hopkins Hospital city: Baltimore state: Maryland zip: 21287 country: United States name: Glenn Rivera, MD role: CONTACT phone: 410-955-4259 email: griver14@jh.edu lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06315816 id: DokuzEU-1 briefTitle: Virtual Reality Used During Tooth Extraction and Extirpation Treatment overallStatus: RECRUITING date: 2024-04-01 date: 2024-08-01 date: 2024-09-30 date: 2024-03-18 date: 2024-03-18 name: Murat Bektaş class: OTHER briefSummary: This study carriy out to evaluate the effect of virtual reality glasses used during tooth extraction and extirpation treatment under local anesthesia on anxiety and fear in children aged 7-10 years. conditions: Anxiety and Fear conditions: Tooth Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The population will consist of children between the ages of 7-10 who presented to the pediatric dental clinic of an oral and dental health center Turkey. The sample size of the study was calculated as GPOWER 3.1 statistical analysis software, based on a significance level of 0.05, a power value of 80%, and an effect size of 0.15 (medium effect size). Considering 10% attrition, it will plan to sample a total of 80 children, including 40 in the experimental group and 40 in the control group. Eventually, a total of 120 children, 60 in the experimental group and 60 in the control group,will include in the study to reveal the relationship between the variables more clearly. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The data will be analyzed by a statistician blind to the groups. whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: virtual reality glasses used during tooth extraction and extirpation treatment measure: Anxiety Means measure: Fear Means sex: ALL minimumAge: 7 Years maximumAge: 10 Years stdAges: CHILD facility: Hakkari University status: RECRUITING city: Hakkari state: Merkez country: Turkey name: Dilek Demir Kösem, PhD role: CONTACT phone: +9005534813290 email: dilekdemir624@gmail.com lat: 37.57444 lon: 43.74083 facility: Hakkari University status: RECRUITING city: Hakkari country: Turkey name: Dilek Demir Kösem, PhD role: CONTACT phone: +9005534813290 email: dilekdemir624@gmail.com lat: 37.57444 lon: 43.74083 hasResults: False

 nctId: NCT06315803 id: ChinaPLAGH20230601 briefTitle: Randomized Controlled Clinical Study of Biplanar Ultrasound-guided Puncture of Lumbar Interforamen overallStatus: COMPLETED date: 2023-06-23 date: 2024-02-01 date: 2024-02-01 date: 2024-03-18 date: 2024-03-18 name: Yi Mao class: OTHER name: National Natural Science Foundation of China briefSummary: The goal of this clinical trial is to compare Xplane ultrasound with radiography for guidance of lumbar interforamen puncture in patients with lumbar disc herniation. The main question\[s\] it aims to answer are:

* The feasibility that the Xplane ultrasound assists surgeon in mastering lumbar interforamen puncture faster than radiography.
* The clinical accuracy and safety of the Xplane ultrasound-guidance lumbar interforamen puncture faster.

Participants will undergo lumbar interforamen puncture with guidance of Xplane ultrasound or radiography. If there is a comparison group: Researchers will compare the first success rate, number of punctures, number of radiographies, puncture time and operator confidence score. conditions: Lumbar Disc Herniation conditions: Percutaneous Endoscopic Lumbar Discectomy conditions: Three-dimension Ultrasound conditions: Learning Curves studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE maskingDescription: There are practical differences in operation and blind methods cannot be achieved. count: 76 type: ACTUAL name: Real-time 3D Xplane ultrasound measure: the first success rate measure: number of punctures measure: number of radiographies measure: puncture time measure: operator confidence score measure: operative time measure: incidence of puncture relevant complications measure: satisfaction of patients measure: visual analog scale of pain measure: Oswestry disability index measure: modified Macnab criteria type sex: ALL minimumAge: 16 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese PLA General Hospital city: Beijing state: Beijing zip: 100853 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06315790 id: TN BTX-A Trial briefTitle: Safety and Efficacy of Botulinum Toxin A in Patients With Trigeminal Neuralgia overallStatus: RECRUITING date: 2023-11-01 date: 2025-10-01 date: 2025-10-01 date: 2024-03-18 date: 2024-03-18 name: Henrik Schytz class: OTHER briefSummary: This is a double-blind randomized clinical trial comparing the pain reduction of individuals treated with BTX-A and placebo as well as evaluating possible changes in neuroinflammatory biomarkers. The trial lasts 16 weeks, with a 4-week baseline phase and a 12-week randomization phase. Four visits are planned: 1) Introduction and baseline data collection, 2) Medical evaluation and treatment assignment, 3) Follow-up with biomarker analysis, and 4) Trial conclusion interview. 80 participants will be included and randomized 1:1. conditions: Trigeminal Neuralgia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Botulinum toxin A name: Isotonic saline measure: Proportion of responders in botulunim toxin A and placebo group measure: Biomarkers measure: Tear fluid CGRP measure: 50 % reduction measure: 75 % reduction measure: Prolonged 30 % reduction measure: Change in paroxysms measure: PGI-C measure: PENN Facial Pain Scale-Revised (PENN-FPS-R) measure: Patient's guess measure: Dropouts measure: Side effects measure: Pure paroxysmal pain vs. paroxysms with concomitant pain measure: Idiopathic vs. classical trigeminal neuralgia measure: Patients with severe pain measure: Gender distribution measure: Disease duration sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Danish Headache Center status: RECRUITING city: Glostrup zip: 2600 country: Denmark name: Henrik Schytz, MD role: CONTACT phone: +4528761824 email: henrik.winther.schytz.01@regionh.dkonh.dk name: Henrik Schytz, MD role: PRINCIPAL_INVESTIGATOR lat: 55.6666 lon: 12.40377 hasResults: False

 nctId: NCT06315777 id: FRGS/1/2021/SKK01/UKM/02/1 briefTitle: GREM1, HAS2 and PTGS2 Gene Expression Following the in Vitro Maturation (IVM) overallStatus: RECRUITING date: 2021-07-01 date: 2024-07-01 date: 2024-07-31 date: 2024-03-18 date: 2024-03-18 name: National University of Malaysia class: OTHER briefSummary: Poor ovarian reserve (POR) is an adverse prognostic factor for In-Vitro Fertilization (IVF) success. Numerous established data showed low live birth rates per IVF cycle; 6 to 10%, including the usage of In-Vitro Maturation (IVM). In Malaysia, POR incidence increases mainly from cancer survival, endometriosis, and autoimmune diseases women; therefore, IVM implementation is paramount. In the molecular level, the low competence oocytes showed a low expression of GREM1, HAS2 and PTGS2 in human cumulus cells, thus leading to poor oocyte quality(OQ). Various IVM media had been formulated to enhance the competency and quality of the oocytes to date. Therefore, our study aims to elucidate the GREM1, HAS2 and PTGS2 gene expression as oocyte developmental competency markers among POR women following IVM and tailored to the IVF outcome. conditions: Increased Oocyte Death conditions: in Vitro Maturation conditions: GREM1 Gene Mutation conditions: Cumulus Cell studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ESTIMATED name: cumulus cell oocytes complex (COC) among women with poor ovarian reserve measure: normal ovarian reserve measure: poor ovarian reserve sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Advanced Reproductive Centre status: RECRUITING city: Kuala Lumpur state: Wilayah Persekutuan Kuala Lumpur zip: 56000 country: Malaysia name: Muhammad Azrai AA Abu role: CONTACT phone: +60196410944 email: azraiabu1983@gmail.com lat: 3.1412 lon: 101.68653 hasResults: False

 nctId: NCT06315764 id: Hypertensive patients briefTitle: Effect of the Reflexology on Insomnia Severity Index in Hypertensive Patients overallStatus: COMPLETED date: 2022-01-01 date: 2022-01-30 date: 2023-05-30 date: 2024-03-18 date: 2024-03-18 name: Cairo University class: OTHER briefSummary: In Egypt, there is a dearth of understanding of the benefits of reflexology and aerobic exercise on hypertension patients' quality of life. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group (A):

It consists of twenty female patients suffering from hypertension who underwent medical treatment as well as peddler training three times per week for eight weeks. After four weeks of treatment (post-1) and another four weeks of treatment, the post evaluation was used (post-2).

Group (B):

This group consisted of twenty female patients suffering from hypertension who received the same drugs as group (A) as well as reflexology three times per week for eight weeks primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ACTUAL name: Reflexology measure: Insomnia severity index measure: Short form 36 quality of life questionnaire (SF-36): measure: Blood pressure measurements: sex: FEMALE minimumAge: 35 Years maximumAge: 45 Years stdAges: ADULT facility: Heba Mousa city: Cairo zip: 11517 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06315751 id: NOE-TTS-201 briefTitle: Efficacy and Safety of Gemlapodect in Adults and Adolescents With Tourette Syndrome acronym: Allevia2 overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2026-12-31 date: 2026-12-31 date: 2024-03-18 date: 2024-03-18 name: Noema Pharma AG class: INDUSTRY briefSummary: This study is designed to evaluate the efficacy and safety of gemlapodect (NOE-105) on reducing tics associated with Tourette Syndrome (TS) in adults with TS. Adolescents will be enrolled after a sentinel cohort of adults is complete. conditions: Tourette Syndrome studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 180 type: ESTIMATED name: Gemlapodect name: Placebo measure: Change in tic severity score on the Revised Yale Global Tic Scoring Scale (YGTSS-R) measure: Impact on patient functioning measure: Change in PUTS measure: Safety and Tolerability of gemlapodect measure: Assessment of suicidality and suicidal ideation sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06315738 id: ST266-NEC-201 briefTitle: Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis overallStatus: RECRUITING date: 2024-03-29 date: 2026-12 date: 2027-08 date: 2024-03-18 date: 2024-04-02 name: Noveome Biotherapeutics, formerly Stemnion class: INDUSTRY name: Parexel briefSummary: The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL/kg and 1.0 mL/kg) of once daily (QD) via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC by incidence of treatment emergent adverse events (TEAEs) and SAEs, with a secondary objective to assess preliminary efficacy of the same two dose levels (0.5 mL/kg and 1.0 mL/kg) of QD via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC. conditions: Necrotizing Enterocolitis studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: ST266 measure: Safety and Tolerability endpoint: incidence of adverse events measure: Safety and Tolerability endpoint: incidence of serious adverse events measure: Safety and Tolerability endpoint: Changes in labs and vitals relative to disease progression measure: Efficacy endpoint: Time to pneumatosis resolution measure: Efficacy endpoint: Time to full enteral nutrition assessment measure: Efficacy endpoint: Incidence of abdominal surgical intervention measure: Efficacy endpoint: Change in Neonatal Sequential Organ Failure Assessment (nSOFA) score measure: Exploratory endpoint: All cause mortality measure: Exploratory endpoint: Length of stay in the NICU measure: Exploratory endpoint: Change in weight over time measure: Exploratory endpoint: Change in length over time measure: Exploratory endpoint: Change in head circumference over time measure: Exploratory endpoint: Number of significant apnea events/day over time measure: Exploratory endpoint: Number of significant bradycardia events/day over time measure: Exploratory endpoint: Number of significant temperature instability events/day over time measure: Exploratory endpoint: Time to return to normal bowel sounds measure: Exploratory endpoint: Change in serum C-reactive protein (CRP) measure: Exploratory endpoint: Time to return to normal serum platelet count levels measure: Exploratory endpoint: Incidence of intestinal or colonic strictures measure: Exploratory endpoint: Incidence of sepsis measure: Exploratory endpoint: Incidence of retinopathy measure: Exploratory endpoint: Incidence of bronchopulmonary dysplasia (BPD) measure: Exploratory endpoint: Incidence of pulmonary hypertension (PH) measure: Exploratory endpoint: Incidence of periventricular leukomalacia sex: ALL minimumAge: 2 Weeks maximumAge: 8 Weeks stdAges: CHILD facility: BayCare Health System-St. Joseph's Women's Hospital status: RECRUITING city: Tampa state: Florida zip: 33607 country: United States name: Jenelle Ferry, MD role: CONTACT phone: 813-872-2924 email: jenelle.ferry@baycare.org name: Jenelle Ferry, MD role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 hasResults: False

 nctId: NCT06315725 id: 2024-10504 briefTitle: Effect of Artificial Sweetener (AFS) on Glucose Metabolism in Patients With Type 1 Diabetes (T1D) acronym: AFS_T1D overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-09-01 date: 2027-09-01 date: 2024-03-18 date: 2024-04-16 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER briefSummary: The goal of this randomized crossover study is to test the prediction that consuming carbohydrates will affect insulin release differently depending on whether Non-Nutritive Sweeteners (NNSs) are consumed simultaneously. We aim to determine whether the predicted effects are associated with oral or post-oral sweet taste receptor signaling,. Our study will focus on patients diagnosed with type 1 diabetes (T1D) who are using an artificial pancreas (AP) system, as it allows us to monitor glucose and insulin levels over time.

Participants will drink four different flavored beverages, some with sweet taste blockade and some without, in a counter-balanced order. They will then rate the sweetness of each beverage, and we will collect data from their AP system to monitor insulin and glucose level.

To achieve this, we will conduct a pilot study to assess the effectiveness and best timing of sweet taste blockade in healthy individuals. Insights gained from the pilot study will inform the main study.

Sucralose will be used as the NNS, maltodextrin as the carbohydrate, and Gymnema Sylvestre (GS) as the sweet taste receptor blocker. conditions: Type 1 Diabetes (T1D) conditions: Healthy Subjects studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: OTHER count: 25 type: ESTIMATED name: Sweet taste perception with/without sweet taste blockade measure: Effectiveness and optimal time course of sweet test blockade on sweet taste perception in healthy individuals measure: Mean plasma glucose, basal and bolus insulin changes in individuals with T1D on AP following beverage consumption. measure: Resting Energy Expenditure (REE) and nutrient partitioning changes in individuals with T1D on AP following beverage consumptionT1D on AP following beverage consumption sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06315712 id: 004201 briefTitle: Inspiratory Muscle Training in Burned Adults acronym: Burns overallStatus: COMPLETED date: 2021-01-15 date: 2022-06-16 date: 2023-09-11 date: 2024-03-18 date: 2024-03-18 name: Qassim University class: OTHER name: Cairo University briefSummary: The study outlines burn injury impact, emphasizes need for long-term rehabilitation. Study assesses inspiratory muscle training efficacy in improving respiratory strength, lung function, and exercise capacity in adult burn patients. conditions: Burn Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 52 type: ACTUAL name: inspiratory exercise name: Pulmonary rehabilitation measure: maximal inspiratory pressure measure: maximal inspiratory pressure measure: maximal expiratory pressure measure: maximal expiratory pressure measure: Forced expiratory volume in 1 second measure: Forced expiratory volume in 1 second measure: forced vital capacity measure: forced vital capacity measure: Forced expiratory volume in 1 second/ forced vital capacity ratio measure: Forced expiratory volume in 1 second/ forced vital capacity ratio measure: Functional exercise capacity measure: Functional exercise capacity sex: ALL minimumAge: 20 Years maximumAge: 49 Years stdAges: ADULT facility: Faculty of Physical Therapy, Cairo University city: Giza state: Dokki zip: 11432 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06315699 id: QL000001 id: MR-37-24-002019 type: REGISTRY domain: Chinese Clinical Trial Registry briefTitle: Clemastine Fumarate in the Treatment of Neurodevelopmental Delays in Williams Syndrome overallStatus: RECRUITING date: 2024-03-20 date: 2025-03-02 date: 2025-12-30 date: 2024-03-18 date: 2024-03-18 name: Qilu Hospital of Shandong University class: OTHER briefSummary: This study focuses on therapeutic targets for cognitive, motor, and social impairments in Williams syndrome by reversing brain myelin defects caused by GTF2I. The primary objective of the study was to test and evaluate the initial efficacy and safety of Clomastine fumarate in the treatment of Williams syndrome. conditions: Williams Syndrome conditions: Child conditions: Neurodevelopmental Delay studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: Clemastine Fumarate Tablets name: fructose measure: Anisotropy Score (FA) measure: Radial diffusion rate (RD) measure: Apparent dispersion coefficient（ADC） measure: Magnetization transfer ratio（MTR） measure: SRS Score 2(Social Response Scale2) score measure: Peabody（Motion Estimation Timewarp）score measure: Gesell Development Scale measure: Differential pressure across valves measure: Thyroid hormone value measure: Conners Parent Symptoms Questionnaire Score measure: Vailand-3 scale measure: CSHQ Children's Sleep Habits Questionnaire Score sex: ALL minimumAge: 3 Years maximumAge: 6 Years stdAges: CHILD facility: Qilu Hospital of Shandong University status: RECRUITING city: Tainan state: Shangdong zip: 250012 country: China name: cao aihua role: CONTACT phone: +18560086317 email: xinercah@163.com name: Liu zhiyue role: CONTACT phone: 15665785296 email: mikeydrakon8@gmail.com hasResults: False

 nctId: NCT06315686 id: MA-ENDO-202209 briefTitle: The Dynamic Monitoring of Cerebrospinal Fluid ctDNA overallStatus: RECRUITING date: 2022-09-29 date: 2024-07-31 date: 2024-12-31 date: 2024-03-18 date: 2024-03-18 name: Jiangsu Province Nanjing Brain Hospital class: OTHER briefSummary: Focusing on advanced EGFR mutation in NSCLC patients with leptomeningeal metastasis, vormetinib combined with OMMAYA lateral ventricle chemotherapy (pemetrexed) was used to dynamically monitor ctDNA in cerebrospinal fluid (CSF), analyze the ctDNA gene mutation profile of CSF in different patients, and explore the relationship between ctDNA and efficacy and prognosis. conditions: NSCLC studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: pemetrexed measure: The progression-free survival time（PFS） measure: Incidence of Treatment-Emergent Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing Brain Hospital status: RECRUITING city: Suzhou state: Jiangsu zip: 210029 country: China name: fang S Cun, M.D. role: CONTACT phone: 83728558 phoneExt: 025 email: fang1984@aliyun.com name: fang S cun role: CONTACT phone: 83728558 email: fang1984@aliyun.com lat: 31.30408 lon: 120.59538 hasResults: False

 nctId: NCT06315673 id: STUDY00024562 briefTitle: Digital Assessment of Speech and Fine Motor Control in ALS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-30 date: 2027-03-30 date: 2024-03-18 date: 2024-03-18 name: Milton S. Hershey Medical Center class: OTHER name: BioSensics briefSummary: This is a single-session, case-control study that incorporates digital tools for assessing speech and motor function in motor neuron disease. Patients with motor neuron disease (including amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), and progressive muscular atrophy (PMA)) and age-matched healthy controls will be enrolled. Subjects will complete a speech and handwriting assessment during the study visit on a tablet computer (BioSensics LLC, Newton, MA). We will explore whether these digital biomarkers are sensitive to functional disease severity as reported by the ALS Functional Rating Scale - Revised (ALFRS-R) \[1\]. We will also compare assessment data between the patient and control groups. conditions: Amyotrophic Lateral Sclerosis conditions: Primary Lateral Sclerosis conditions: Progressive Muscular Atrophy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: Digital Speech and Handwriting Assessment measure: Speaking rate during a standardized passage measure: Residual on spiral tracing task measure: ALS Functional Rating Scale- Revised (ALSFRS-R) measure: Forced vital capacity (FVC) measure: Upper motor neuron function measure: Strength testing sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06315660 id: P-2021-627 briefTitle: VR Based Therapy to Treat Anxiety in Dual Diagnosis overallStatus: NOT_YET_RECRUITING date: 2024-11 date: 2026-04 date: 2026-04 date: 2024-03-18 date: 2024-03-18 name: Mental Health Centre Sct. Hans class: OTHER_GOV briefSummary: Dual diagnosis refers to patients with both severe mental illness and substance abuse. Dual diagnosis is therefore a challenging condition to treat, and the group typically represents the most vulnerable individuals in society. Historically, research on dual diagnosis has been underprioritized, and thus, we still do not know enough about how to best assist this vulnerable group.

However, new studies indicate that virtual reality programs can reduce anxiety in patients with psychotic disorders. They achieve this by providing access to a virtual therapist and lifelike environments where patients can challenge their thoughts about the dangers of navigating the world. For both psychotic disorders and substance abuse, we know that anxiety often plays a role in the clinical picture. Therefore, anxiety almost always has an impact on dual diagnosis patients, where it is crucial in maintaining substance abuse and functional impairment. Despite this, anxiety is rarely a focus in existing treatment options, as it is too resource-intensive in addition to an already intensive treatment process.

This study investigates whether the resource barrier can be overcome and whether hospitalized dual diagnosis patients can experience reduced anxiety, fewer relapses, and better outcomes after discharge when their anxiety is treated through partially automated virtual reality therapy. conditions: Dual Diagnosis conditions: Psychosis conditions: Agoraphobia conditions: Social Anxiety Disorder conditions: Substance Use Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is a parallel group, investigator initiated, pragmatic, assessor-blinded, 1:1 randomized, clinical feasibility trial. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: When a participant is randomized to TAU+VR, the senior researcher reveals the allocation to the assigned clinician via secure e-mail. The assigned clinician then schedules the eight therapy sessions with the participant who is thus unblinded to their treatment allocation. If the participant is randomized to TAU, the assigned clinician will inform the participant as soon as possible. The researchers collecting data from the patient and the researchers performing data analysis remain blinded. There are no circumstances wherein unblinding of outcome assessors or data analysists is permissible. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Cognitive Miljeu Therapy name: Virtual Reality based CBT for Anxiety measure: Oxford Agoraphobic Avoidance Scale measure: Client Satisfaction Questionnaire measure: Systems Useability Scale measure: Timeline Followback measure: The Six-item Positive and Negative Symptom Syndrome Scale measure: The Social Functioning Scale measure: The Questionnaire about the Process of Recovery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06315647 id: Difficult CBD cannulation briefTitle: Comparison Between Different Techniques in Difficult CBD Cannulation overallStatus: COMPLETED date: 2019-12-01 date: 2023-01-19 date: 2023-11-20 date: 2024-03-18 date: 2024-03-18 name: Menoufia University class: OTHER briefSummary: This study aims to compare the efficacy and outcomes between double guidewire technique (DGT), trans pancreatic sphincterotomy (TPS) as well as precut and fistulotomy techniques in ERCP in patients defined as having difficult biliary cannulation. conditions: ERCP, Difficult CBD Cannulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: INVESTIGATOR count: 150 type: ACTUAL name: DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation measure: Comparative Study Between Different Interventional Techniques for Difficult Common Bile Duct Cannulation In Endoscopic Retrograde Cholangio-pancreatography sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National liver Institute city: Shibīn Al Kawm state: Menofia zip: 32951 country: Egypt lat: 30.55258 lon: 31.00904 hasResults: False

 nctId: NCT06315634 id: AP210330102 briefTitle: Intrathecal Dexmedetomidine vs Midazolame overallStatus: COMPLETED date: 2021-03-15 date: 2022-03-10 date: 2022-03-10 date: 2024-03-18 date: 2024-03-18 name: National Cancer Institute, Egypt class: OTHER briefSummary: Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries conditions: Postoperative Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 75 type: ACTUAL name: Dexmedetomidine name: Midazolam name: Bupivacain measure: Duration of sensory block measure: Incidence of vomiting occurrence measure: Sedation measure: Change in mean arterial blood pressure measure: Duration of motor block measure: Change in heart rate sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National cancer institute city: Cairo zip: 11796 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06315621 id: 36124 briefTitle: Accuracy of Conventional Impression Versus Intraoral Scanner in Capturing Three Different Nasal Defects overallStatus: COMPLETED date: 2024-02-01 date: 2024-02-20 date: 2024-02-20 date: 2024-03-18 date: 2024-03-18 name: Cairo University class: OTHER briefSummary: For all participants, a conventional facial impression will be done using silicone material then poured and scanned using a desktop scanner which represented the control group (Group 1).

Group 2, involves nasal defects which will be optically scanned using IOS(medit 700 wireless) without facial markers Group 3 involves nasal defects which will be optically scanned using IOS(medit 700 wireless) with facial markers.

STL files of the facial scans and scanned cast obtained from the impression will be exported and saved to be used later for outcome assessment. conditions: Nasal Defect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 15 type: ACTUAL name: Scanning using intraoral scanner with markers name: Scanning using intraoral scanner without markers name: Physical Impression measure: Dimensional accuracy of intraoral scanners sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo University city: Cairo zip: 11865 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06315608 id: MRG24ALS briefTitle: MRG-001 in Patients With Amyotrophic Lateral Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2024-11-01 date: 2024-12-01 date: 2024-03-18 date: 2024-03-18 name: MedRegen LLC class: INDUSTRY briefSummary: The proposed study is an Open-Label, Single-Dose Study to Assess the Safety, and Pharmacodynamics (PD) signals of MRG-001 in Patients with Amyotrophic Lateral Sclerosis (ALS). MRG-001 will be administered subcutaneously 3 times per week for 2 weeks. This cycle will be repeated for 3 months. In total, patients are expected to receive 18 injections over the span of 3 months. conditions: Amyotrophic Lateral Sclerosis conditions: Lou Gehrig Disease conditions: Motor Neuron Disease conditions: Motor Neuron Atrophy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: MRG-001 measure: Assessment of Treatment-Emergent Adverse Events measure: Stem Cell Mobilization measure: Regulatory T-cell Mobilization measure: Change in Disease Progression sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06315595 id: 15-003511 id: NCI-2024-01895 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 15-003511 type: OTHER domain: Mayo Clinic Institutional Review Board id: P30CA015083 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA015083 id: R01EB031790 type: NIH link: https://reporter.nih.gov/quickSearch/R01EB031790 briefTitle: Improvements in Dynamic Contrast-Enhanced MR Angiography and Perfusion overallStatus: RECRUITING date: 2015-09-30 date: 2030-09-30 date: 2030-09-30 date: 2024-03-18 date: 2024-03-19 name: Mayo Clinic class: OTHER name: National Cancer Institute (NCI) name: National Institute for Biomedical Imaging and Bioengineering (NIBIB) briefSummary: This study evaluates contrast-enhanced MR angiography and contrast-enhanced MR perfusion imaging for the visualization of blood vessels and enhancing tissues with better spatial detail and improved temporal fidelity compared to current methods. conditions: Prostate Neoplasm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Non-Interventional Study measure: Improved performance in contrast-enhanced magnetic resonance imaging (MRI) as used for angiography and perfusion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Arizona status: ACTIVE_NOT_RECRUITING city: Scottsdale state: Arizona zip: 85259 country: United States lat: 33.50921 lon: -111.89903 facility: Mayo Clinic in Rochester status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 name: Stephen J. Riederer, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06315582 id: STU00220487 briefTitle: Surgical Approach to Uterine Septum overallStatus: RECRUITING date: 2024-03-11 date: 2025-08-26 date: 2026-02-26 date: 2024-03-18 date: 2024-03-18 name: Northwestern University class: OTHER briefSummary: The objective of this study is to determine if the use of scissors without electrosurgery is superior to bipolar electrosurgery for resection of uterine septum. The investigators will be comparing procedure-level variables such as operative time, complications, and need for additional procedures. conditions: Uterine Septum conditions: Surgical Complication conditions: Septum; Uterus conditions: Treatment Side Effects conditions: Treatment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized single blinded study primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants will be randomized using www.randomizer.org algorithm. They will be assigned to arm in the operating room where they will get that intervention. When they get to Post Anesthesia Care Unit, they will be unblinded. Surgeon will be blinded until patient is in operating room and envelope with randomization is opened. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 40 type: ESTIMATED name: Removal of uterine septum with hysteroscopic scissors without electrosurgery. name: Hysteroscopic septoplasty utilizing bipolar electrosurgery measure: Procedure-level variables: operative time hysteroscopic septoplasty measure: Procedure-level variables: Surgical Cost measure: Procedure-level variables: Fluid deficit measure: Resolution of uterine septum measure: Compare adverse events measure: Comparing patient recovery and satisfaction sex: FEMALE minimumAge: 22 Years maximumAge: 44 Years stdAges: ADULT facility: Northwestern Medicine Prentice Women's Hospital status: RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Milad Madgy, MD role: CONTACT email: mmilad@nm.org lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06315569 id: KY20242030-C-1 briefTitle: A Multicentre Clinical Study on the Correlation Between Exercise and Hyperuricemia overallStatus: RECRUITING date: 2024-01-17 date: 2024-06-01 date: 2024-11-01 date: 2024-03-18 date: 2024-03-18 name: Xijing Hospital class: OTHER name: Air Force 986 Hospital briefSummary: This project is a multi-center clinical study on the correlation between exercise and hyperuricemia. The purpose is to explore the correlation between exercise and hyperuricemia, find out the metabolic rule of uric acid after exercise, and provide scientific evidence and clinical guidance for how to exercise scientifically and reasonably in patients with hyperuricemia. This trial is a multicenter, prospective, randomized controlled clinical trial with 100 participants. Inclusion criteria: 1. Patients with hyperuricemia (fasting uric acid \> 420μmol/L twice on different days); 2. Men aged between 18 and 35; 3. Able to complete baseline fitness test (3000m run time less than 14 minutes); 4. Fully informed consent, signed informed consent exclusion criteria: 1. Heart, liver and kidney insufficiency; 2. Patients with malignant tumor, thyroid disease, systemic lupus erythematosus, myeloma, lipodystrophy, diabetes mellitus; 3. Patients with secondary hyperuricemia caused by medicine or other diseases; 4. People who take uric acid lowering drugs; 5. People with related motor dysfunction or other factors that can easily cause discomfort after exercise 6. Those with mental disorders or communication disorders, and those who do not cooperate during the experiment A total of 100 subjects were included according to the scheduling criteria. SPSS23.0 software was used to generate a random number table, and random numbers were calculated according to 1: The results of the groups were sealed in opaque envelopes, and the envelopes were kept by A third party responsible for randomization. According to the contents of the envelopes, the subjects were divided into group A, which exercised for 24 hours after 3000m exercise, and group B, which exercised for 48 hours after 3000m exercise. During the 48-hour observation period after each exercise, the changes of uric acid after exercise were explored. To provide scientific evidence and clinical guidance for patients with hyperuricemia how to exercise scientifically and rationally.

Patients must meet all inclusion and exclusion criteria to be eligible to participate in the study. After determining patients' eligibility for the study, the researcher should fully explain the nature, purpose, risks and benefits of the study to the subjects before the study, and assure the patients that they have the right to withdraw at any time after agreeing to participate in the study, and the subjects should sign a written informed consent after fully considering and agreeing to participate in the study. The process of obtaining informed consent should be correctly recorded in all case report forms in this study.

Baseline data such as blood uric acid, blood biochemistry, blood routine, urine routine, uric acid and demographic characteristics were collected after the patients were enrolled.

The patients were randomly divided into two groups: Group A and group B: Group A and group B: Group A and group B: Group A and group B: Group A and group B: Group A and group B: Group A and group B: Group A.

Within 48 hours after each 3000m exercise, the subjects' blood uric acid was detected immediately after exercise (within 5 minutes), 1 hour, 2 hours, 3 hours, 12 hours, 24 hours, 36 hours, 48 hours. Blood uric acid, blood biochemistry, blood routine, urine routine, urine uric acid and other information were collected again 24 hours after intervention.

From January 2024 to February 2024, we plan to draft clinical study protocols, investigator manuals, case reports, informed consent forms and other documents, and submit them to the Ethics Committee of the research sponsor for review and approval; February 2024 - March 2024: Complete the training of all researchers and officially start the research; March 2024 - August 2024: Participants were enrolled for the experiment; August 2024 - November 2024: collate and collect data, conduct statistical analysis, and confirm research results conditions: Hyperuricemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: Run 3000 meters measure: Uric acid metabolism in patients with hyperuricemia after exercise sex: MALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Xijing Hospital status: RECRUITING city: Xi'an state: Shanxi zip: 710032 country: China name: XiangLiang Meng role: CONTACT phone: +8613730192056 email: 997815173@qq.com lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06315556 id: 22539 briefTitle: An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK) overallStatus: RECRUITING date: 2024-03-05 date: 2027-03-31 date: 2027-04-30 date: 2024-03-18 date: 2024-04-12 name: Bayer class: INDUSTRY briefSummary: This is an observational study in which only data from babies with retinopathy of prematurity (ROP) who are being treated with aflibercept (Eylea) in prefilled syringe (PFS) using a paediatric dosing device (PDD) are collected and studied.

ROP is a condition that affects the eyes of preterm babies. It occurs when the baby's retina, the part of the eye that senses light, does not develop normally. This may result in vision problems, including blindness, if left untreated. Preterm babies are born before 37 weeks of pregnancy. ROP is more likely to develop in babies who are born before 32 weeks of pregnancy or weigh less than 1.5 kilograms at birth.

Aflibercept is a drug that is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth of blood vessels in the retina.

Aflibercept in PFS given using a PDD is approved for the treatment of babies with ROP. The prefilled syringe will be fitted with an injection needle to give aflibercept. And a PDD is a tool used to give the right amount of aflibercept to children in a safe manner.

Since there are other treatments which are commonly used for babies with ROP, the extent of use of aflibercept given using a PDD is unknown.

The main purpose of this study is to:

* find the number of preterm babies who are treated with aflibercept using a PDD in the UK
* inform whether this number is enough to perform a study to learn about the long-term safety of aflibercept given using a PDD in babies with ROP

An additional purpose of this study is to describe characteristics including age, sex, and race, and signs and symptoms of ROP observed in babies being treated with aflibercept using a PDD.

The data will come from a database called the National Neonatal Research Database. The study will cover the period from March 2024 to March 2025, if the number of babies found is enough to perform the safety study. If not, data will be collected till April 2027.

In this study only available data from preterm babies born during the study period are collected. No visits or tests are required as part of this study. conditions: Retinopathy of Prematurity conditions: Preterm Infants studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED name: Aflibercept (Eylea) measure: Number of participants treated with Eylea PFS+PDD upon completion of 1- or 3-years following market introduction measure: Summary of patient characteristics reported as number of participants with different categories measure: Summary of maternal factors reported as number of participants with different categories measure: Summary of comorbidities reported as number of participants with different categories measure: Summary of clinical condition and resource utilization reported as number of participants with different categories measure: Summary of clinical condition and resource utilization reported as days measure: Summary of outcomes of the premature infants reported as number of participants with different categories measure: Summary of ocular disease and treatment reported as number of participants with different categories sex: ALL maximumAge: 1 Year stdAges: CHILD facility: Many locations status: RECRUITING city: Multiple Locations country: United Kingdom hasResults: False

 nctId: NCT06315543 id: KY20222255-F-1 briefTitle: A Multicentre Clinical Study on the Correlation Between Drinking Water and Hyperuricemia overallStatus: RECRUITING date: 2024-01-15 date: 2024-06-01 date: 2024-11-01 date: 2024-03-18 date: 2024-03-18 name: Xijing Hospital class: OTHER name: Air Force 986 Hospital briefSummary: The name of this study is a multicentre clinical study on the correlation between drinking water and hyperuricemia. The purpose of this study is to clarify the correlation between drinking water and hyperuricemia. To explore the clinical effect of reducing uric acid by drinking water, and provide scientific evidence and clinical guidance for reducing uric acid by drinking water. The study design was a multicenter, prospective, randomized controlled clinical trial with a total of 88 participants. 1. Inclusion criteria: patients with hyperuricemia (fasting uric acid between 420-540μmol/L twice on different days and no drug treatment); Aged 18-65 years; Less than 1500mL of daily water intake recommended by the minimum dietary guidelines (assessed by dietary review combined with water diaries); Fully informed consent. Sign informed consent. 2. Exclusion criteria: patients with heart, liver and renal insufficiency; Patients with malignant tumor, thyroid disease, systemic lupus erythematosus, myeloma, lipodystrophy, polycystic ovary syndrome, diabetes mellitus; Patients with secondary hyperuricemia caused by medicine or other diseases; People who have gastrointestinal discomfort or have a history of gastrointestinal surgery, or other people who are not suitable for drinking more water; Patients with mental disorders or communication disorders, and those who did not cooperate during the experiment. A total of 88 subjects were included according to the exclusion criteria. SPSS26.0 software was used to generate a random number table, and random numbers were calculated according to 1: The results of the groups were sealed in opaque envelopes, and the envelopes were kept by A third party responsible for randomization. The subjects were divided into two groups according to the contents of the envelopes: A constant drinking water observation group (maintaining the original drinking water volume) and B adequate drinking water intervention group (drinking an additional 1650mL of water per day (3 bottles of 550mL bottled water) on the basis of the original drinking water volume). During the 2-week observation period, the effects of constant drinking water and sufficient drinking water on blood uric acid, 24 h uric acid determination, urine osmotic pressure and other indicators were evaluated, and the effectiveness of sufficient drinking water in reducing blood uric acid was determined, and the applicable population was explored.

Observation items and detection time: 1. During the screening period, the following data were collected: age, nationality, place of residence, education, occupation, height, weight, waist circumference, disease history, drug use history, drinking, smoking, normal water intake, urine volume, urine color and uric acid value. 2. Pre-test data: drinking water, urination, diet, psychological investigation, blood uric acid, blood biochemistry, routine blood routine, urine routine, uric acid, urine osmotic pressure, systolic blood pressure, diastolic blood pressure, heart rate, frequency of gout attack, whether to take urico-lowering drugs, whether to take other drugs that affect uric acid. 3. After the test: Fasting blood uric acid was monitored on the 2nd, 4th, 6th, 8th, 10th and 14th day respectively; Urge patients to record water diary and urination diary every day. At the end of the experiment, blood uric acid, blood biochemistry, blood routine, urine routine, urine uric acid, urine osmotic pressure, systolic blood pressure, diastolic blood pressure and heart rate were tested again. Safety assessment indicators: edema, gastrointestinal discomfort, electrolytes, blood pressure, heart rate. conditions: Hyperuricemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 88 type: ESTIMATED name: Drink water measure: Blood uric acid change sex: MALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xijing Hospital status: RECRUITING city: Xi'an state: Shanxi zip: 710032 country: China name: Li Peng role: CONTACT phone: 029-84771794 email: XJYYLLWYH@163.com lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06315530 id: sh12053 briefTitle: Effect of Telitacicept on Antibody Titers in Primary APS Patients overallStatus: RECRUITING date: 2023-01-01 date: 2025-12-31 date: 2026-12-31 date: 2024-03-18 date: 2024-03-18 name: Ruijin Hospital class: OTHER briefSummary: The purpose of this study is to evaluate the regulatory effect of Telitacicept on antibody titers in primary antiphospholipid syndrome patients carrying high-risk antiphospholipid antibody profiles. conditions: Antiphospholipid Syndrome (APS) studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Telitacicept name: SOC measure: The proportion of patients with decreased aPL titer at week 48 of treatment measure: new thrombotic event measure: Effects of Telitacicept on the genotype, phenotype, and functional heterogeneity of T and B cells measure: The incidence and severity of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ruijin Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200025 country: China role: CONTACT phone: 0086-0021-64370045 name: Chengde Yang, Dr role: PRINCIPAL_INVESTIGATOR name: Hui Shi, Dr role: SUB_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06315517 id: AU24 id: 1792-23P type: OTHER_GRANT domain: The Dairy Alliance briefTitle: Double Crossover Casein Type Tolerance Trial overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2024-12 date: 2024-03-18 date: 2024-04-05 name: Auburn University class: OTHER briefSummary: The investigators will recruit 45 fluid milk avoiding adults to participate in a five-week double-blind, double-crossover study in which the physiological responses to increasing doses of lactose-free (A1-rich milk), A2 milk, and lactose-free A2 milk will be explored. conditions: Dairy Intolerance conditions: Healthy Adults studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized controlled, double-blinded, double-crossover trial primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Conventional lactose-free cow's milk name: Nonconventional (A2) cow's milk name: Nonconventional (A2) lactose-free cow's milk measure: Gastrointestinal Distress Scores measure: Breath Hydrogen (ppm) measure: Breath Methane (ppm) measure: Blood Glucose (mg/dl) measure: Stool microbiome composition measure: Stool Beta-casomorphin-7 (BCM-7) measure: Stool intestinal fatty acid binding protein (I-FABP) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Auburn University city: Auburn state: Alabama zip: 36849 country: United States name: Andrew D Frugé, PhD role: CONTACT lat: 32.60986 lon: -85.48078 hasResults: False

 nctId: NCT06315504 id: Nephrotic Syndrome Cohort briefTitle: Circulating Factors in Nephrotic Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2034-04-01 date: 2034-04-01 date: 2024-03-18 date: 2024-03-19 name: Iain Bressendorff class: OTHER briefSummary: A prospective observational study to investigate the treatment-associated changes of circulating factors associated with glomerular diseases among patients with de novo nephrotic syndrome admitted to hospital for a kidney biopsy. conditions: Nephrotic Syndrome conditions: Membranous Nephropathy conditions: Minimal Change Disease conditions: Primary Focal Segmental Glomerulosclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 104 type: ESTIMATED name: Observation measure: levels of anti-nephrin in blood by ELISA measure: changes in auto-antibodies in blood associated with membranous nephropathy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06315491 id: CBX-12-201 briefTitle: A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-04 date: 2026-04 date: 2024-03-18 date: 2024-03-18 name: Cybrexa Therapeutics class: INDUSTRY briefSummary: The purpose of this study is to assess the safety, tolerability, and efficacy of CBX-12 in female subjects with platinum resistant or refractory ovarian cancer at 2 doses; 125 mg/m2 every 21 days or 100 mg/m2 every 21 days. conditions: Platinum-resistant Ovarian Cancer conditions: Refractory Ovarian Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: CBX-12 measure: Percentage of Subjects With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] measure: Incidence of Subjects With Treatment Emergent Adverse Events (TEAEs) measure: Median Duration of Response (DoR) measure: Progression-Free Survival (PFS) measure: Plasma levels of CBX-12 (AUC0-24hr) measure: Plasma levels of CBX-12 (Cmax) measure: Plasma levels of CBX-12 (Tmax) measure: Plasma levels of CBX-12 (T1/2) measure: Plasma levels of Exatecan (AUC0-24hr) measure: Plasma levels of Exatecan (Cmax) measure: Plasma levels of Exatecan (Tmax) measure: Plasma levels of Exatecan (T1/2) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06315478 id: Hybrid regimen for H.pylori briefTitle: Safety and Efficacy of Triple and Quadruple Regimens as First Line Therapy for Management of Helicobacter Pylori Infection in Egyptians overallStatus: COMPLETED date: 2021-02-01 date: 2021-03-16 date: 2021-11-01 date: 2024-03-18 date: 2024-03-18 name: Helwan University class: OTHER briefSummary: Our study aimed to investigate the efficacy and safety of hybrid regimen as a first line therapy for H. pylori eradication compared to triple and quadruple regimens in attempt to overcome antibiotic resistance conditions: H.Pylori Infection studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: Omeprazole 20 MG Oral Tablet name: Amoxicillin 500Mg Tab name: Clarithromycin 500Mg Tab measure: stool antigen retest sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Badr hospital city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06315465 id: AIIMSA00647 briefTitle: Efficacy of MAD as add-on Therapy in Comparison With Standard of Care in Children With ASD overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2026-01-01 date: 2026-01-01 date: 2024-03-18 date: 2024-03-18 name: All India Institute of Medical Sciences, New Delhi class: OTHER briefSummary: In general ketogenic diet is a recognized as an efficient non pharmacological treatment for children with refractory epilepsy. However, in the last decade, it has been tried for many neurological disorders in children including ASD, neurodegenerative disorders.

Studies have shown that KD also helps in improvement of cognition, social skills, language function, and stereotypies. There is a limited number of reports of improvements after KD treatment, was insufficient evidence to attest the practicability of the KD as a treatment for ASD, but it is still a good indicator that this diet is a promising therapeutic option for this disorder. There are no major RCT's, hence raises concerns about the reliability and generalizability of findings. Majority of studies have used combined ketogenic diet therapy rather than single diet therapy and not many studies have compared add-on dietary intervention with standard of care. When compared to classic KD diet Modified Atkin's Diet is less restrictive, more palatable, more feasible and early response can be achieved. In summary, the rationale for conducting this study lies in the importance of add on dietary therapy in form of Modified Atkin's Diet along with standard of care for improvement of behavioral symptoms in children with ASD aged 3-8 years.

This study aims to provide valuable insights that it can improve behavioral symptoms in ASD, early and ultimately improve the developmental outcomes in these children. conditions: Modified Atkins Diet conditions: Autism Spectrum Disorder conditions: Standard of Care studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Open Label Randomized Controlled Trial primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Modified Atkin's Diet with standard of care name: Standard of Care measure: To evaluate the efficacy of add-on Modified Atkin's Diet therapy with standard of care as compared to standard of care alone in children with Autism Spectrum Disorder aged 3-8 years measure: To evaluate the efficacy of add-on Modified Atkin's Diet therapy with standard of care as compared to standard of care alone in children with Autism Spectrum Disorder aged 3-8 years measure: To compare the change in the cognitive ability as measured by Developmental Quotient(DQ)in children receiving Modified Atkin's Diet with standard of care vs standard of care alone in children with Autism Spectrum disorder aged 3-8 years. measure: To compare the change in the cognitive ability as measured by Social Quotient(SQ)in children receiving Modified Atkin's Diet with standard of care vs standard of care alone in children with Autism Spectrum disorder aged 3-8 years. measure: To compare the change in the cognitive ability as measured by Intelligence Quotient(IQ)in children receiving Modified Atkin's Diet with standard of care vs standard of care alone in children with Autism Spectrum disorder aged 3-8 years. measure: To compare the quantitative reduction in behavioral problems using Child Behavior Checklist (CBCL) in children receiving Modified Atkin's Diet with standard of care vs standard of care alone in children with Autism Spectrum Disorder aged 3-8 years. measure: To compare the change in sleep related problems using Children's Sleep Habit Questionnaire (CSHQ)children receiving Modified Atkin's Diet with standard of care vs standard of care alone in children with Autism Spectrum Disorder age measure: To compare the resting state fMRI findings in a subset of patients in the two arms measure: To assess the compliance in children with Autism Spectrum Disorder receiving add-on Modified Atkin's Diet with standard of care measure: To assess the adverse effect profile in children with Autism Spectrum Disorder receiving add-on Modified Atkin's Diet with standard of care sex: ALL minimumAge: 3 Years maximumAge: 8 Years stdAges: CHILD hasResults: False

 nctId: NCT06315452 id: PremaVitaD briefTitle: FREQUENCY OF VITAMIN D DEFICIENCY IN PREMATURE NEWBORN BORN BEFORE 32 WEEKS AND/OR WITH A BIRTH WEIGHT UNDER 1500g acronym: PremaVitaD overallStatus: ACTIVE_NOT_RECRUITING date: 2022-02-01 date: 2024-02-01 date: 2024-06-01 date: 2024-03-18 date: 2024-03-18 name: Fondation Hôpital Saint-Joseph class: OTHER briefSummary: Vitamin D plays an important role in phosphocalcic metabolism and bone homeostasis in newborns. Premature newborns are at risk of vitamin D deficiency and may require supplementation. In this context, the French Society of Pediatrics (Société Française de Pédiatrie) recommends systematic vitamin D testing at 1 month.

The aim of this study was to determine the frequency of vitamin D deficiency in premature newborns. conditions: Vitamin D Deficiency studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 110 type: ACTUAL measure: Vitamine D deficiency frequency measure: vitamine D deficiency and maternal or feotal caracteristics measure: vitamine D deficiency and premature newborn comorbidities measure: effect of supplementation sex: ALL minimumAge: 1 Day maximumAge: 6 Months stdAges: CHILD facility: Hôpital Saint Joseph city: Paris zip: 75014 country: France lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06315439 id: Multi-RELAMI briefTitle: Digital Confocal Microscopy for Real-time Diagnosis of Pancreatic Solid Lesion acronym: Multi-RELAMI overallStatus: COMPLETED date: 2023-01-01 date: 2023-11-30 date: 2023-11-30 date: 2024-03-18 date: 2024-03-18 name: Campus Bio-Medico University class: OTHER briefSummary: Endoscopic ultrasound-guided (EUS) tissue acquisition is the current standard of care for the diagnosis of pancreatic solid lesions but it is burdened by a non-negligible risk of non-diagnostic or inconclusive results.

Ex-vivo fluorescence confocal laser microscopy (FCM) with MAVIG VivaScope® 2500M-G4 could allow real time assessment of adequacy and diagnosis of the sample. conditions: Pancreas Adenocarcinoma conditions: Endoscopic Ultrasound conditions: Digital Pathology studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 78 type: ACTUAL name: Endoscopic ultrasound fine needle biopsy measure: Diagnostic accuracy sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Campus Bio Medico city: Rome state: Roma zip: 00191 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06315426 id: GR1802-011 briefTitle: A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis(SAR). overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-10 date: 2024-12 date: 2024-03-18 date: 2024-03-21 name: Genrix (Shanghai) Biopharmaceutical Co., Ltd. class: INDUSTRY briefSummary: Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease. conditions: Allergic Rhinitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: GR1802 injection name: Placebo measure: Change from Baseline in rTNSS( reflective total nasal symptom scores) measure: Change from Baseline in rTOSS( reflective total ocular symptom scores) measure: Change from Baseline in rTNSS measure: Mean change from baseline in iTNSS(instantaneous total nasal symptom scores) measure: Mean change from baseline in iTOSS(instantaneous total ocular symptom scores) measure: Change from baseline in VAS(Visual Analog Scale) score measure: Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores measure: Adverse events (AEs) measure: Immunogenicity characteristics sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06315413 id: Composite plug vs d-PTFE briefTitle: Composite Plug vs d-PTFE Membrane in Socket Preservation overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-08-01 date: 2025-12-01 date: 2024-03-18 date: 2024-03-18 name: Cairo University class: OTHER briefSummary: The aim of the current study is to compare the effect socket sealing with flowable resin composite compared to dense polytetrafluoroethylene membrane after filling the extraction site with xenograft particles in terms of soft and hard tissue changes, procedural time, post operative pain, patients' satisfaction, and cost effectiveness. conditions: Alveolar Bone Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Socket preservation using xenograft and composite plug name: Socket preservation using xenograft and intentionally exposed d-PTFE measure: Change in horizontal bone dimension measure: Change in Vertical bone dimension measure: Keratinized tissue thickness measure: Procedural time measure: Post-operative pain measure: Patient Satisfaction measure: Incidence of complications sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of oral and dental medicine, Cairo university city: Cairo zip: 4240310 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06315400 id: ING-07-2023 briefTitle: Efficacy and Safety of Ingavirin®, Capsules, 60 mg, in Children With Influenza and Other Acute Respiratory Viral Infections overallStatus: RECRUITING date: 2023-12-19 date: 2025-12-31 date: 2025-12-31 date: 2024-03-18 date: 2024-04-01 name: Valenta Pharm JSC class: INDUSTRY briefSummary: The study is planned to evaluate the therapeutic efficacy and safety of Ingavirin®, capsules, 60 mg, in the treatment of influenza or other acute respiratory infections in children from 13 to 17 years compared with placebo. conditions: Influenza, Human conditions: Acute Respiratory Infection conditions: Common Cold studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Ingavirin® name: Placebo measure: Percentage of patients with normalization of body temperature at Visit 3 (Day 3) measure: Timeframe for normalization of body temperature from the start of treatment, measured in hours measure: Time of cough disappearance from the moment of treatment initiation measure: Percentage of patients with absence of catarrhal syndrome measure: Percentage of patients with absence of intoxication syndrome measure: Average body temperature on days 1, 2, 3, 4 and 5 from the start of therapy measure: Percentage of patients with complications of influenza/acute respiratory infection that developed between days 1-6 and days 1-21 from the start of study drug administration measure: Percentage of patients with severe complications of influenza/acute respiratory infection that developed between days 1-6 and days 1-21 from the start of study drug administration measure: Assessment of vital signs: blood pressure measure: Assessment of vital signs: heart rate measure: Assessment of vital signs: respiratory rate measure: Assessment of vital signs: body temperature measure: Evaluation of concomitant therapy measure: Laboratory evaluation: leukocyte formula measure: Laboratory evaluation: hemoglobin measure: Laboratory evaluation: leukocyte count measure: Laboratory evaluation: platelet count measure: Laboratory evaluation: red blood cell count measure: Laboratory evaluation: hematocrit measure: Laboratory evaluation: erythrocyte sedimentation rate measure: Laboratory evaluation: blood glucose measure: Laboratory evaluation: total protein measure: Laboratory evaluation: total bilirubin measure: Laboratory evaluation: AST measure: Laboratory evaluation: ALT measure: Laboratory evaluation: creatinine measure: Laboratory evaluation: urea measure: Laboratory evaluation: triglycerides measure: Laboratory evaluation: urinalysis measure: Frequency of adverse events (AEs) and serious adverse events (SAEs) measure: Percentage of patients who discontinued study due to AE/SAE sex: ALL minimumAge: 13 Years maximumAge: 17 Years stdAges: CHILD facility: GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation status: RECRUITING city: Rostov-na-Donu country: Russian Federation name: Tatiana V Zolotova, Prof. role: CONTACT phone: +7-928-1049101 email: tvzolotova1953@yandex.ru lat: 47.23135 lon: 39.72328 facility: GBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation status: RECRUITING city: Tomsk country: Russian Federation name: Yulia G Samoilova, MD, PhD role: CONTACT phone: +7-3822530127 email: samoilova_y@inbox.ru lat: 56.49771 lon: 84.97437 facility: GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation status: RECRUITING city: Yaroslavl zip: 150000 country: Russian Federation name: Ivan G Sitnikov, Prof. role: CONTACT phone: +7-4852-736769 email: sitnikov@ysmu.ru lat: 57.62987 lon: 39.87368 hasResults: False

 nctId: NCT06315387 id: GIB-01-01-2023 briefTitle: Safety, Tolerability and Pharmacokinetics of 4-MUST, Tablets, 128 mg (Valenta Pharm JSC) During Single and Multiple Oral Administration in Healthy Volunteers overallStatus: RECRUITING date: 2023-12-04 date: 2024-12-31 date: 2024-12-31 date: 2024-03-18 date: 2024-03-18 name: Valenta Pharm JSC class: INDUSTRY briefSummary: Study of safety, tolerability and pharmacokinetic parameters of different doses of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers conditions: Cholecystitis studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 42 type: ESTIMATED name: 4-MUST, 1 tablet name: 4-MUST, 2 tablets name: 4-MUST, 3 tablets measure: Pharmacokinetics - Cmax measure: Pharmacokinetics - tmax measure: Pharmacokinetics - AUC0-t measure: Pharmacokinetics - AUC0-inf measure: Pharmacokinetics - AUCextr measure: Pharmacokinetics - t1/2 measure: Pharmacokinetics - kel measure: Pharmacokinetics - MRT measure: Pharmacokinetics - Vd measure: Pharmacokinetics - CL measure: Pharmacokinetics - number of terminal timepoints measure: Adverse event type measure: Adverse event frequency measure: Adverse event severety measure: Drop-outs associated with adverse events sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Limited Liability Company "Medical Center Eco-Safety" status: RECRUITING city: St. Petersburg zip: 19119 country: Russian Federation name: Vasiliy Vasilyuk, MD,PhD, Prof. role: CONTACT phone: +7 (812) 500-52-03 phoneExt: 5001 email: vasilyuk_vb@ecosafety.ru lat: 59.93863 lon: 30.31413 hasResults: False

 nctId: NCT06315374 id: FJUH112267 briefTitle: 3D-Printed Aerosolized Medication Delivery Assist Device in Patients With Chronic Respiratory Diseases overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-07-31 date: 2024-07-31 date: 2024-03-18 date: 2024-03-19 name: Fu Jen Catholic University class: OTHER briefSummary: The purpose of this study is to investigate the auxiliary benefits of three-dimensional printed activating assistive devices for soft-mist inhaler on patients' utilization habit. conditions: Chronic Pulmonary Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 60 type: ESTIMATED name: Use soft mist inhaler name: Use soft mist inhaler with a 3D assistive device measure: satisfaction survey sex: ALL minimumAge: 45 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fu Jen Catholic University Hospital, Fu Jen Catholic University city: New Taipei City zip: 24352 country: Taiwan name: Ke-Yun Chao, PhD role: CONTACT phone: +886-905-301-879 email: ck_qq@hotmail.com name: Ke-Yun Chao, PhD role: PRINCIPAL_INVESTIGATOR lat: 25.01111 lon: 121.44583 hasResults: False

 nctId: NCT06315361 id: 2445 briefTitle: DIAbetes and NAFLD acronym: DIANA overallStatus: ACTIVE_NOT_RECRUITING date: 2019-05-20 date: 2035-12-31 date: 2035-12-31 date: 2024-03-18 date: 2024-03-18 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Non-alcoholic hepatic steatosis (NAFLD) is characterised by the excessive accumulation of triglycerides in the liver and is often associated, in the absence of significant alcohol consumption, with insulin resistance and metabolic syndrome with which it shares the most frequent clinical manifestations (hypertension, dyslipidaemia, visceral adiposity, glucose intolerance). Due to the pandemic spread of obesity and diabetes and by virtue of better control of viral hepatitis, NAFLD is the most common cause of liver damage in Western countries with a prevalence of around 20-30% of the general population.

The clinical impact of NAFLD in diabetes is considerable and represents a real driver of the major clinical outcomes that impact on the health of the individual, consequently creating a real 'burden of disease' especially in those populations considered to be at higher risk of disease severity.

Individuals with diabetes are, in fact, those at greatest risk of developing the clinical sequelae of NAFLD and often do not receive adequate hepatological support and a correct hepatic pathology. In fact, it has been documented in the literature that the presence of diabetes increases the severity of liver damage, bringing the risk of NASH up to 80% and increasing the risk of significant fibrosis to 30-40% of subjects with hepatic steatosis as well as representing an independent predictor for significant fibrosis. Lastly, the increased risk of hepatocarcinoma in subjects with diabetes and NAFLD should not be overlooked, as documented by our group and confirmed in a large Italian case series.

In subjects with diabetes, moreover, the presence of NAFLD is not only associated with worse glycaemic control, but also with micro- and macro-vascular complications as well as nephrological and neuropathic complications and increased mortality.

Therefore, the possibility of applying the non-invasive fibrosis scores currently available for NAFLD on a large scale, in a population at high risk of progressive liver disease, would make it possible to characterise (a) the true epidemiology of significant fibrosis (F3 or higher); (b) allow primary prevention actions to be carried out by optimising the use of resources or by identifying subjects at greater risk of damage progression; (c) understand, in cases with a long history of disease the true prevalence of clinical outcomes; (d) understand the epidemiology of comorbidities and polypharmacy as a function of significant fibrosis. conditions: NAFLD conditions: Diabetes conditions: NASH conditions: Fibrosis, Liver conditions: Cirrhosis, Liver conditions: Liver Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 600 type: ESTIMATED measure: Prevalence of significant fibrosis by non invasive tests measure: Identification of MALO (major liver outcomes) measure: Identification of MACE sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UOSD Diabetologia, Catholic University of Rome, Fondazione Policlinico Gemelli IRCCS city: Roma state: Rome/lazio/italy zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06315348 id: URI_116301123 briefTitle: Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment acronym: Piezo_Ortho overallStatus: RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-03-18 date: 2024-03-21 name: Universidad Complutense de Madrid class: OTHER name: Osteology Foundation briefSummary: Research Question

While the reduction in treatment times and the patient satisfaction after periodontally accelerated osteogenic orthodontics (PAOO) are well sustained in the scientific literature, there is still controversy regarding if grafting leads to i) change of the periodontal phenotype and ii) greater stability of post-orthodontic treatment outcomes, highlighting the need of controlled clinical trials.

Aims of the Project

The aim of this randomized clinical trial (RCT) is to compare piezocision-assisted orthodontics, concomitant to soft tissue grafting (volume-stable collagen matrix), with piezocision-assisted orthodontics, concomitant to bone grafting with a xenograft and a native collagen membrane, in orthodontic non-growing patients. The primary aim will be to determine the impact of this surgical protocol on the hard and soft tissue changes occurring on the buccal aspect of the dentition. Secondary objectives will include the assessment of the comparative impact on treatment duration, rate of tooth movements, presence of root resorption, periodontal parameters, bone level changes and patient-reported outcome measures (PROMs) between the two groups. conditions: Dental Malocclusion conditions: Maxillary Deficiency studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Comparative 2-arm parallel double-blinded randomized controlled clinical trial primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Blinded parties will not be aware of the type augmentation used during the intervention. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: flapless alveolar decortication with augmentation measure: Soft tissue contour changes pre- and post- orthodontic therapy measure: Plaque index (PlI) measure: Bleeding on probbing (BoP) measure: Probing depth (PD) measure: External apical root resorption (EARR) measure: Orthodontic tooth movement measure: Percentage of residual pockets (PD>4 mm). measure: Soft tissue thickness by PIROP ultrasound scanner measure: Gingival microvasculature measure: PROMs measure: Adverse events (AEs) sex: ALL minimumAge: 16 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Odontology, University Complutense Madrid status: RECRUITING city: Madrid zip: 28040 country: Spain name: Eduardo Montero, Prof role: CONTACT phone: +34 91 3941901 email: eduardomonterosolis@ucm.es name: Conchita Martin, Prof role: CONTACT phone: +34 91 3941901 email: mariacom@ucm.es lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06315335 id: UP0118 briefTitle: A Study to Assess the Safety and Pharmacokinetics of a Single Dose of UCB9741 in Healthy Caucasian and Japanese Participants overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-07-29 date: 2025-07-29 date: 2024-03-18 date: 2024-04-16 name: UCB Biopharma SRL class: INDUSTRY briefSummary: The purpose of the study is investigate the safety, tolerability and pharmacokinetic of UCB9741 after 2 dose strengths administered subcutaneous as a single-dose in healthy Caucasian and Japanese participants. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: UCB9741 name: Placebo measure: Occurrence of TEAEs measure: Occurrence of treatment-emergent SAEs measure: Cmax measure: AUC0-t measure: AUCinf sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06315322 id: EP0224 id: 2023-508095-11-00 type: REGISTRY domain: EU Trial Number id: U1111-1303-1174 type: OTHER domain: Universal Trial Number briefTitle: A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2029-02-28 date: 2029-02-28 date: 2024-03-18 date: 2024-03-18 name: UCB Biopharma SRL class: INDUSTRY briefSummary: The purpose of the study is to investigate the long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy. conditions: Childhood Absence Epilepsy conditions: Juvenile Absence Epilepsy studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Brivaracetam Film-coated tablet name: Brivaracetam oral solution measure: Incidence of treatment-emergent adverse events (TEAEs) during the study measure: Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of investigational medicinal product (IMP) during the study measure: Incidence of serious adverse events (SAEs) during the study measure: Incidence of IMP related TEAEs during the study sex: ALL minimumAge: 2 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06315309 id: IRB-300012281 (UAB 23146) briefTitle: Trial of 2 Step ATG for Acute GVHD Prevention Post Myeloablative Allogeneic Stem Cell Transplant overallStatus: NOT_YET_RECRUITING date: 2024-06-29 date: 2025-10-29 date: 2027-02 date: 2024-03-18 date: 2024-04-03 name: University of Alabama at Birmingham class: OTHER briefSummary: The purpose of this study is to test whether the combination of the drugs called tacrolimus (Tac), methotrexate (MTX) and new dosing strategy of another drug called (rabbit Anti-thymocyte Globulin \[ATG\]) will help prevent the development and/or improve severity of acute and/or chronic GVHD. conditions: GVHD,Acute conditions: Acute Leukemia conditions: Myelodysplastic Syndromes conditions: Myeloproliferative Disorders studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 29 type: ESTIMATED name: ATG Combined with Tacrolimus and Mini Methotrexate measure: To estimate the therapeutic success of 2-step ATG dosing platform in patients undergoing reduced intensity allogeneic transplantation for treatment of hematologic malignances sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Zaid S Al Kadhimi, MD role: PRINCIPAL_INVESTIGATOR name: Manuel Espinoza-Gutarra, MD role: SUB_INVESTIGATOR name: Omer Jamy, MD role: SUB_INVESTIGATOR name: Donna Salzman, MD role: SUB_INVESTIGATOR name: Razan Mohty, MD role: SUB_INVESTIGATOR name: Lauren Shea, MD role: SUB_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False

 nctId: NCT06315296 id: iRISID-2023-1985 briefTitle: An Interactive Time-Restricted Diet Intervention (txt4fasting) for Reducing Neurocognitive Decline and Improving Survival in Patients With Brain Metastases From Breast or Lung Cancer overallStatus: RECRUITING date: 2023-12-13 date: 2028-06-30 date: 2028-12 date: 2024-03-18 date: 2024-03-18 name: Thomas Jefferson University class: OTHER briefSummary: This clinical trial tests the effectiveness of an interactive time-restricted diet intervention (txt4fasting) in reducing neurocognitive decline and improving survival outcomes after stereotactic radiosurgery in patients with breast or lung cancer that has spread to the brain (brain metastases). Lung cancer and breast cancer are the two most frequent causes of brain metastases. The diagnosis of brain metastases is associated with poorer survival and tumor-induced and treatment-related side effects. Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. Patients who receive stereotactic radiosurgery for brain metastases may experience less neurocognitive side effects than with other types of brain radiation, but may still be at risk for their brain metastases growing, spreading, or getting worse. Patients with obesity and diabetes have been shown to have worse survival and increased radiation-related side effects. Evidence demonstrates that simply changing meal timing can have a positive impact on multiple health outcomes. Time-restricted eating, or prolonged nighttime fasting, has been proven to have positive effects on heart disease risk reduction, weight control management and chemotherapy side effect reduction. Txt4fasting may be effective in decreasing neurocognitive decline and improving survival outcomes in patients undergoing stereotactic radiosurgery for brain metastases from breast or lung cancer. conditions: Anatomic Stage IV Breast Cancer AJCC v8 conditions: Metastatic Breast Carcinoma conditions: Metastatic Lung Carcinoma conditions: Metastatic Malignant Neoplasm in the Brain conditions: Stage IV Lung Cancer AJCC v8 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: Behavioral Dietary Intervention name: Text Message-Based Navigation Intervention name: Internet-Based Intervention name: Dietary Counseling and Surveillance name: Stereotactic Radiosurgery name: Biospecimen Collection name: Magnetic Resonance Imaging name: Neurocognitive Assessment name: Questionnaire Administration name: Interview name: Internet-Based Intervention name: Stereotactic Radiosurgery name: Text Message-Based Navigation Intervention name: Biospecimen Collection name: Magnetic Resonance Imaging name: Neurocognitive Assessment name: Questionnaire Administration name: Interview measure: Accrual rate measure: Attrition rate measure: Time-restricted eating (TRE) compliance rate measure: Incidence of adverse effects (AEs) measure: Patient satisfaction measure: Neurocognitive function decline measure: Neurocognitive function decline measure: Neurocognitive function decline measure: Neurocognitive function decline measure: Intracranial progression free survival (PFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sidney Kimmel Cancer Center at Thomas Jefferson University status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19107 country: United States name: Nicole Simone role: CONTACT phone: 215-955-6702 email: Nicole.Simone@jefferson.edu lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06315283 id: TV44749-BA-10196 id: 2023-505664-11-00 type: REGISTRY domain: CTIS briefTitle: An Open-Label Trial to Assess the Comparative Bioavailability of TV-44749 to Oral Olanzapine in Participants With Schizophrenia overallStatus: RECRUITING date: 2024-03-20 date: 2025-04-15 date: 2025-04-15 date: 2024-03-18 date: 2024-04-22 name: Teva Branded Pharmaceutical Products R&D, Inc. class: INDUSTRY briefSummary: The primary objective of the study is to evaluate the comparative bioavailability of TV-44749 administered subcutaneous (sc) to oral olanzapine (ZYPREXA®) at steady state in participants with schizophrenia.

A secondary objective of this trial is to evaluate the safety and tolerability of multiple doses of TV-44749 administered sc in participants with schizophrenia.

Another secondary objective of this trial is to compare additional pharmacokinetic parameters of TV-44749 administered sc with oral olanzapine (ZYPREXA®) at steady state in participants with schizophrenia.

The total duration of participation in the trial for each participant is planned to be approximately 21 weeks. conditions: Schizophrenia studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 116 type: ESTIMATED name: TV-44749 name: Oral olanzapine measure: Area under the curve (AUC) of TV-44749 measure: AUC of oral olanzapine measure: Number of participants with at least one treatment-emergent adverse event during treatment with TV-44749 measure: Number of participants with at least one treatment-emergent serious adverse event during treatment with TV-44749 measure: Number of participants with at least one injection site adverse event during treatment with TV-44749 measure: Maximum observed plasma drug concentration at steady state (Cmax,ss) of TV-44749 measure: Minimum observed plasma drug concentration at steady state (Cmin,ss) of TV-44749 measure: Cmax,ss of oral olanzapine measure: Cmin,ss of oral olanzapine sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Teva Investigational Site 15739 status: RECRUITING city: Los Alamitos state: California zip: 90720 country: United States lat: 33.80307 lon: -118.07256 facility: Teva Investigational Site 15740 status: RECRUITING city: Torrance state: California zip: 90504 country: United States lat: 33.83585 lon: -118.34063 facility: Teva Investigational Site 15738 status: RECRUITING city: Hollywood state: Florida zip: 33024 country: United States lat: 26.0112 lon: -80.14949 facility: Teva Investigational Site 15741 status: RECRUITING city: Atlanta state: Georgia zip: 30308 country: United States lat: 33.749 lon: -84.38798 facility: Teva Investigational Site 15742 status: RECRUITING city: Decatur state: Georgia zip: 30030 country: United States lat: 33.77483 lon: -84.29631 facility: Teva Investigational Site 15737 status: RECRUITING city: Marlton state: New Jersey zip: 08053 country: United States lat: 39.89122 lon: -74.92183 hasResults: False

 nctId: NCT06315270 id: 24K040-001 briefTitle: To Explore the Feasibility of Dynamic Changes of TCR Diversity in Peripheral Blood in Monitoring Recurrence and Evaluating Prognosis of Epithelial Ovarian Cancer overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2029-03-20 date: 2029-03-20 date: 2024-03-18 date: 2024-04-01 name: The First Hospital of Jilin University class: OTHER briefSummary: This project proposes to elucidate the functional impact of T cells in cancer progression and treatment through a comprehensive TCR profiling study and a longitudinal cohort study in patients with advanced epithelial ovarian cancer. Our findings aim to provide clinical insights for monitoring treatment response in a non-invasive way and demonstrate the association of TCR diversity with clinical outcomes and the potential role of TCR profiling in cancer prognosis. conditions: Epithelial Ovarian Cancer conditions: Stage III Ovarian Cancer conditions: Stage IV Ovarian Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Analysis of TCR genealogy data sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06315257 id: J23105sIRB id: IRB00388854 type: OTHER domain: Johns Hopkins briefTitle: A Clinical Trial to Assess PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-08 date: 2027-03 date: 2024-03-18 date: 2024-03-18 name: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins class: OTHER name: National Institutes of Health (NIH) briefSummary: A Feasibility Trial of PVX7 vaccine in advanced cervical cancer patients who have completed primary definitive therapy. conditions: Cervical Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: PVX7 measure: Safety of PVX7 as assessed by adverse events measure: Feasibility of PVX7 measure: Cellular Immune Response measure: Immune Response measure: Presence of circulating HPV DNA sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06315244 id: 2558 briefTitle: Perforating Cutaneous Nerve Injection Efficacy in Chronic Coccydynia: A Randomized, Double-Blind Study overallStatus: RECRUITING date: 2024-04-01 date: 2024-07-01 date: 2024-10-01 date: 2024-03-18 date: 2024-03-18 name: Sisli Hamidiye Etfal Training and Research Hospital class: OTHER briefSummary: Interventions targeting the perforating cutaneous nerve are relatively new to the literature, with a safe side-effect profile but lacking high-quality studies. Their effectiveness remains at the level of case presentations. According to the hypothesis expressed in these publications, coccydynia might be an overlooked cause due to the compression of the perforating cutaneous nerve where it pierces the sacrotuberous ligament and becomes superficial. Ultimately, it is hypothesized that injection of dextrose into this ligament and the sensory area of this nerve will resolve these symptoms due to nerve entrapment, similar to other entrapment neuropathies treated with 5% dextrose, like carpal tunnel syndrome. conditions: Coccyx Disorder conditions: Coccyx Injury studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: US Guided Perineural Injection and Neuroprolotherapy measure: Effectiveness of Perforating Cutaneous Nerve Injection measure: Change in Pressure Pain Threshold measure: Change in Quality of Life sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Sisli Hamidiye Etfal Training and Research Hospital status: RECRUITING city: Istanbul zip: 34371 country: Turkey name: Enes Efe Is, MD role: CONTACT phone: +902123735000 email: enefeis@gmail.com name: Enes Efe Is, MD role: PRINCIPAL_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06315231 id: SIM0308-02-Y-2-201 briefTitle: Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2024-12-31 date: 2025-05-30 date: 2024-03-18 date: 2024-03-18 name: Simcere Pharmaceutical Co., Ltd class: OTHER briefSummary: This is a multicenter, randomized, double-blind, placebo-controlled, exploratory Phase II clinical trial.

The goal of this clinical trial is to assess the safety and efficacy of edaravone dexborneol sublingual tablets for post-stroke cognitive impairment in patients with acute ischemic stroke.

Participants will be required to receive 12 weeks treatment of edaravone dexborneol sublingual tablets or placebo during this study. The safety and efficacy endpoints will be compared in the patients with edaravone dexborneol sublingual tablets or placebo. conditions: Post-stroke Cognitive Impairment studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Edaravone dexborneol sublingual tablet name: Placebo measure: Adverse Events measure: Number of discontinuation/withdrawal patients measure: The changes of the Vascular Dementia Assessment Scale-cognitive subscale (VaDAS-Cog) scores. measure: The incidence of Post Stroke Cognitive Impairment（PSCI ）in each group measure: The changes of Mini-Mental State Examination (MMSE) score measure: The changes of Montreal Cognitive Assessment (MoCA) scale measure: The changes of MoCA subscales measure: Modified Rankin Scale (mRS) scores measure: The changes of National Institutes of Health Stroke Scale sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of USTC Anhui Provincial Hospital city: Hefei state: Anhui country: China name: Jiong Shi, Doctor role: CONTACT email: Jshi2022@ustc.edu.cn lat: 31.86389 lon: 117.28083 facility: The First Hospital of Jilin University city: Changchun state: Jilin country: China name: Li Sun role: CONTACT email: sunli99@jlu.edu.cn lat: 43.88 lon: 125.32278 facility: The First People's Hospital of Huzhou city: Huzhou state: Zhejiang country: China name: Ru Sun, Doctor role: CONTACT email: sunjin2010@tom.com lat: 30.8703 lon: 120.0933 hasResults: False

 nctId: NCT06315218 id: Pro2023000968 briefTitle: Examining the Health Effects of iTHRIVE 365 Among Black Same Gender Loving Men overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-04 date: 2028-04 date: 2024-03-18 date: 2024-03-21 name: Rutgers, The State University of New Jersey class: OTHER name: Positive Impact Health Centers name: George Washington University name: Carnegie Mellon University name: Emory University name: Columbia University name: Arizona State University name: THRIVE Social Services Inc briefSummary: This research study aims to test the effectiveness, reach, and maintenance over time of the iTHRIVE 365 intervention for Black same gender loving men (SGLM) living with HIV. iTHRIVE 365 is a SGLM community-developed multicomponent mHealth intervention that aims to: 1) Support daily health promotion via HIV and psychological health education and health maintenance reminders; 2) Foster positive social connections among SGLM via online moderated forums, interpersonal chats, and community calendars; 3) Connect clients to SGLM-affirming healthcare, including HIV treatment and mental healthcare; 4) Provide resources for housing, transportation, and other economic empowerment. conditions: Sexual and Gender Minorities conditions: Social Stigma conditions: Medication Adherence conditions: Depressive Symptoms conditions: Anxiety Symptoms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 350 type: ESTIMATED name: iTHRIVE 365 HIV care intervention measure: Antiretroviral (ART) Medication Use measure: ART adherence-Long Lag Assessments measure: Daily Diary Substance Use measure: Substance Use-Long Lag Assessments measure: Depressive Symptoms measure: Depressive Symptoms-Long Lag measure: Anxiety Symptoms measure: Anxiety Symptoms-Long Lag measure: Emotion Regulation Emotion Regulation measure: Emotion Regulation-Long Lag Assessments measure: COPE measure: COPE-Long Lag Assessments sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06315205 id: ROV-LEBE-2023-01 id: 2023-503948-13 type: EUDRACT_NUMBER briefTitle: Evaluation of the Pharmacokinetics, Safety, and Tolerability of IM Letrozole LEBE in Healthy Post-menopausal Women acronym: LEILA-1 overallStatus: RECRUITING date: 2023-07-26 date: 2025-01 date: 2025-01 date: 2024-03-18 date: 2024-03-19 name: Rovi Pharmaceuticals Laboratories class: INDUSTRY briefSummary: This is a Phase I, open label, sequential, single ascending dose (SAD) study to evaluate the pharmacokinetic (PK), safety, and tolerability of Letrozole LEBE in healthy post-menopausal women. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: Letrozole LEBE 75 mg name: Letrozole LEBE 150 mg name: Letrozole LEBE 225 mg measure: λz measure: Cmax measure: Clast measure: tmax measure: tlag measure: t1/2 measure: AUC∞ measure: AUClast measure: E1 measure: SE1 measure: E2 measure: λz measure: Cav measure: Cmin, ss measure: Cmax,ss measure: tmax measure: t1/2 measure: AUCτ sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Investigational Site number CZ-01 status: RECRUITING city: Praha country: Czechia lat: 50.08804 lon: 14.42076 hasResults: False

 nctId: NCT06315192 id: CIV-22-10-041006 briefTitle: Stroke Alarm Efficacy Trial acronym: StrokeAlarmEFF overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2026-06-30 date: 2024-03-18 date: 2024-03-18 name: Region Skane class: OTHER briefSummary: The aim of this study is to test the efficacy of the CE-marked wearable system Stroke Alarm to identify the onset of a stroke with unilateral arm motor deficit within 3 hours of onset.

This is a multicenter, prospective observational single-arm trial with a registry-based propensity matched control population.

A total of 500 patients will be included in the trial. An interim analysis will determine if the stroke onset frequency is sufficient to determine the main outcome. Should the number of stroke events differ from what is expected at interim analysis, study enrollment will continue to increase cohort size.

Patients who meet the criteria for participation will, after signing consent, be included and receive the Stroke Alarm bracelets that are used for 3 months. Study data will be collected as baseline at inclusion, at follow-up 3 months after inclusion and by using national Swedish registry data after completion of the study.

Patients with elevated stroke risk according assessed by presence of specific criteria associated with elevated risk caused by:

1. recent TIA, OR
2. recent stroke without persisting arm motor deficit, OR
3. atrial fibrillation A control population matched for age, sex, NIHSS score and health care region will be identified in the Swedish national stroke registry, Riksstroke, and used for comparison.

The combined efficacy goal is at least 60% sensitivity for Stroke Alarm b of stroke with unilateral arm motor deficit within 3 hours of onset (with a 95% confidence interval above 30%) and a specificity of at least 80% using a clinical stroke diagnosis as gold standard. conditions: Stroke Acute conditions: Atrial Fibrillation conditions: TIA studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a multicenter, prospective observational single-arm trial with a registry-based propensity matched control population. primaryPurpose: DIAGNOSTIC masking: NONE count: 500 type: ESTIMATED name: Stroke Alarm measure: Time from onset of stroke with unilateral arm motor deficit until alarm by the device. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Skane University hospital city: Lund zip: 22185 country: Sweden name: Johan Wasselius, MD, PhD role: CONTACT phone: 800-555-5555 phoneExt: +46-46173082 email: johan.wasselius@gmail.com name: Magnus Esbjörnsson, MD role: PRINCIPAL_INVESTIGATOR lat: 55.70584 lon: 13.19321 hasResults: False

 nctId: NCT06315179 id: STUDY00004616 briefTitle: Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation (STRIDE) acronym: STRIDE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-01 date: 2030-01 date: 2024-03-18 date: 2024-03-19 name: Seattle Children's Hospital class: OTHER name: Allen Institute briefSummary: This is a prospective observational study collecting long-term clinical data and samples for research in pediatric inflammatory bowel disease (IBD) patients with gut inflammation and a control cohort of pediatric patients with disorders of the brain-gut interactions (DBGI) with no detectable gut inflammation. conditions: Inflammatory Bowel Diseases conditions: Crohn Disease conditions: Ulcerative Colitis conditions: Indeterminate Colitis conditions: Functional Abdominal Pain Syndrome conditions: Functional Bowel Disorder conditions: Esophageal Diseases conditions: Gastroduodenal Disorder conditions: Bowel Dysfunction conditions: Gallbladder Diseases conditions: Sphincter of Oddi Dysfunction conditions: Anorectal Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Esophagogastroduodenoscopy (EGD) with biopsy name: Colonoscopy w/ biopsy measure: Bio-repository sample collection for spatial transcriptomics measure: Paris Classification of Crohn's Disease measure: Montreal Classification of Crohn's disease measure: Paris Classification of Ulcerative Colitis/Indeterminate Colitis measure: Montreal Classification of Ulcerative Colitis/Indeterminate Colitis measure: Disorder of Gut-Brain Interaction classification measure: Physician's Global Assessment (PGA) sex: ALL minimumAge: 6 Years maximumAge: 21 Years stdAges: CHILD stdAges: ADULT facility: Seattle Children's Hospital city: Seattle state: Washington zip: 98105 country: United States name: Mason E Nuding role: CONTACT phone: 206-987-0055 email: mason.nuding@seattlechildrens.org name: Clinical Research Coordinator role: CONTACT phone: 206-987-2521 email: giresearch@seattlechidlrens.org name: Hengqi Zheng, MD role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06315166 id: CIP-PLG_CLINICAL-22-04 briefTitle: Study on Using Radiofrequency to Treat Moderate to Severe Acne overallStatus: RECRUITING date: 2024-04-10 date: 2025-09 date: 2025-12 date: 2024-03-18 date: 2024-04-11 name: Pollogen class: INDUSTRY name: Lumenis Be Ltd. briefSummary: Evaluation of the safety and efficacy of fractional radiofrequency for the treatment of moderate to severe acne vulgaris. conditions: Moderate to Severe Acne Vulgaris studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: triLift/Legend Pro+ Fractional RF System measure: Evaluate the Efficacy of Fractional RF for the Treatment of Moderate to Severe Acne Vulgaris measure: Overall Improvement of Acne measure: Subjective Satisfaction with the Treatment Results sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Cosmedic Dermatology (CosmedicDerm) status: RECRUITING city: Grosse Pointe state: Michigan zip: 48230 country: United States name: Shauna Ryder Diggs, MD role: CONTACT phone: 313-882-5777 email: hello@drshaunadiggs.com name: Jamila Ammary role: CONTACT phone: +1-313-882-5777 email: hello@drshaunadiggs.com name: Shauna Ryder Diggs, MD role: PRINCIPAL_INVESTIGATOR lat: 42.38615 lon: -82.91186 hasResults: False

 nctId: NCT06315153 id: KS2023077-1 briefTitle: Comprehensive Assessment of Atherosclerotic Ischemic Stroke Risk and Development of a Prediction Model acronym: CAIS-pre overallStatus: ACTIVE_NOT_RECRUITING date: 2022-01-03 date: 2024-04-01 date: 2026-04-01 date: 2024-03-18 date: 2024-03-18 name: Xuanwu Hospital, Beijing class: OTHER name: The First Hospital of Jilin University briefSummary: This observational study was designed for the assessment of plaque vulnerability in patients with carotid atherosclerotic stenosis and the development of predictive models for the occurrence and recurrence of atherosclerotic ischemic stroke.

The objectives of the study were as follows: first, to integrate the degree of carotid stenosis and plaque characteristics assessed by vascular ultrasound for a comprehensive assessment of plaque vulnerability; second, to develop an assessment tool for the risk of future ischemic stroke in patients with asymptomatic carotid stenosis by combining vascular risk factors, serologic markers, carotid ultrasound characteristics, and contrast-enhanced ultrasonographic parameters; and third, to incorporate vascular ultrasound parameters into existing predictive models of ischemic stroke recurrence risk to develop a risk assessment tool for atherosclerotic ischemic stroke.

The main questions it aims to answer are:

* How to screen high-risk patients and those eligible for revascularization from asymptomatic carotid stenosis patients for primary prevention of stroke.
* How to improve the prediction accuracy of atherosclerotic ischemic stroke based on existing prediction models for secondary prevention of stroke. conditions: Carotid Stenosis conditions: Ischemic Stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 500 type: ESTIMATED measure: The occurrence of ischemic stroke measure: The recurrence of ischemic stroke sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The first hospital of Jilin university city: Changchun state: Jilin zip: 130021 country: China lat: 43.88 lon: 125.32278 facility: Xuanwu Hospital, Capital Medical University city: Beijing zip: 100053 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06315140 id: 22-00248 id: 1R01ES033545-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01ES033545-01 id: 5R01ES033545-02 type: NIH link: https://reporter.nih.gov/quickSearch/5R01ES033545-02 briefTitle: Assessing and Addressing Community Exposures to Environmental Contaminants overallStatus: RECRUITING date: 2023-02-16 date: 2027-04 date: 2027-04 date: 2024-03-18 date: 2024-03-18 name: NYU Langone Health class: OTHER name: National Institute of Environmental Health Sciences (NIEHS) briefSummary: The purpose of this study is to build on our equitable, eight-year Tribal-academic partnership with the Ramapough Nation of northern NJ to advance tradition-centered farming practices and management strategies supporting sustainable food systems to relieve local food insecurity and nutritional deficiency, prevent disease and promote health. Furthermore, assessing the extent of environmental contamination, individual toxicant burdens and micronutrient levels and health disorders in Ramapough Tribal members of both sexes as outlined in the following:

* Collect in-person/online survey information on demographics, health and food intake, nutrition, food security, and psychosocial stressors, and perform core anthropometric measurements (i.e., height, weight, body mass index, body circumference and blood pressure) at enrollment on Tribal members to inform health promotion strategies and community actions.
* Determine individual-level contaminant burdens and micronutrient concentrations (e.g., iron, calcium, folate, vitamins) in urine and blood from surveyed (sub-aim 1a) Ramapough Turtle Clan volunteers.
* Test soil, plants and surface water where Turtle Clan residents live, recreate and attend church in Ringwood, NJ using a community-based, citizen scientist approach. conditions: Environmental Exposure studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: Proportion of individuals with heavy metal contaminants in home water samples measure: Proportion of individuals with heavy metal and metalloid contaminations in blood biospecimens measure: Proportion of individuals with heavy metal and metalloid contaminations in urine biospecimens measure: Proportion of individuals with insufficient blood serum micronutrient levels measure: Proportion of individuals with health disorders sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health status: RECRUITING city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06315127 id: 23-0119-A briefTitle: The CanDo (Canadian Donor Milk) Trial overallStatus: RECRUITING date: 2023-11-28 date: 2024-11-28 date: 2025-03-31 date: 2024-03-18 date: 2024-03-18 name: Mount Sinai Hospital, Canada class: OTHER name: Mitacs briefSummary: The goal of this clinical trial is to learn about the impact of donor milk vs formula supplementation on human milk feeding and the health outcomes of infants who require supplementation in well-baby units. It aims to explore whether supplementation with donor milk vs formula for infants during the initial hospital stay in a well-baby unit will increase both the exclusivity and duration of breastfeeding at 4 months. The Investigators will also explore whether the type of supplementation will positively affect measures of newborns' health, growth, behavior, feeding efficacy, and parental stress. Each participating infant born to a diabetic mother OR born small for his/her gestational age (\<2500 grams) is assigned at random to 2 groups. The groups are: 1) Donor milk: all babies in this group will receive pasteurized donor milk from a trusted milk bank. 2) Formula: all babies in this group will receive formula as a standard of care. conditions: Small for Gestational Age at Delivery conditions: Gestational Diabetes conditions: type1diabetes conditions: Type2diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 112 type: ESTIMATED name: Human donor milk name: Formula measure: Donor milk supplementation and exclusive breastfeeding rate at 4 months measure: Exploring donor milk supplementation and exclusive or any breastfeeding rate at 1, 2, and 3 months measure: Exploring donor milk supplementation and breastfeeding self-efficacy scores at 1, 2, 3 and 4 months measure: Exploring donor milk supplementation and glucose concentrations during hospital stay measure: Exploring donor milk supplementation and percent weight loss during hospital stay measure: Exploring donor milk supplementation and the length of hospital stay measure: Exploring donor milk supplementation and weight measurements measure: Exploring donor milk supplementation and length measurements measure: Exploring donor milk supplementation and head circumference measurements measure: Exploratory outcome: exploring donor milk supplementation and infant temperament scores measure: Exploratory outcome: exploring donor milk supplementation and parent's anxiety measure: Exploratory outcome: exploring donor milk supplementation and parent's depression measure: Exploratory outcome: exploring donor milk supplementation and maternal cortisol concentrations sex: ALL maximumAge: 2 Hours stdAges: CHILD facility: Labour and Delivery at Mount Sinai Hospital status: RECRUITING city: Toronto state: Ontario zip: M5G 1X5 country: Canada name: Kim Dart, RN role: CONTACT phone: 4165864800 phoneExt: 6825 email: kim.dart@sinaihealth.ca lat: 43.70011 lon: -79.4163 facility: Maternal Fetal Medicine and Placenta clinics status: RECRUITING city: Toronto state: Ontario zip: M5G 1Z5 country: Canada name: Natasha Milligan role: CONTACT phone: 4165864800 phoneExt: 6419 email: natasha.milligan@sinaihealth.ca lat: 43.70011 lon: -79.4163 facility: Placenta Clinic status: RECRUITING city: Toronto state: Ontario zip: M5G 1Z5 country: Canada name: Jennifer Vaughan role: CONTACT email: jennifer.vaughan@sinaihealth.ca lat: 43.70011 lon: -79.4163 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-09-11 uploadDate: 2024-03-13T17:34 filename: Prot_000.pdf size: 425804 hasResults: False

 nctId: NCT06315114 id: p-2023-15049 id: H-23064491 type: OTHER domain: Regional Committee of Health Research Ethics (VEK) briefTitle: A Transdiagnostic Mentalization-based Intervention for Parents With Mental Disorders acronym: LIGHTHOUSE overallStatus: RECRUITING date: 2024-03-11 date: 2028-04-01 date: 2028-04-01 date: 2024-03-18 date: 2024-03-18 name: Mental Health Services in the Capital Region, Denmark class: OTHER name: University of Copenhagen briefSummary: The aim of this randomised clinical trial is to evaluate the short and longterm effects of a transdiagnostic mentalization-based intervention (Lighthouse MBT Parenting Program) compared to care as usal (CAU) for parents with a mental disorder in adult mental health service. conditions: Mental Disorder conditions: Behavior Disorders conditions: Diagnosis, Psychiatric conditions: Diagnosis Dual conditions: Severe Mental Disorder conditions: Mental Illness conditions: Psychiatric Disorder conditions: Psychiatric Disease conditions: Psychiatric Illness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 170 type: ESTIMATED name: Lighthouse MBT Parenting Program (LPP) name: Care as usual (CAU) measure: Parenting stress assessed with Parenting Stress Index - Short Form (PSI-4-SF) measure: Psychological adjustment in children assessed with the Strenght and Difficulties Questionnaire - Extended version (SDQ) measure: Quality of life in parents assessed with the World Health Organization Questionnaire of Life - BREF (WHOQL-BREF) measure: Family functioning assessed with the McMaster Family Assessment Device - General Functioning Scale (FAD-GF). measure: Childhood adversity in children assessed with the Adverse Child Experciences Questionnaire (ACE) extended version developed by the Center for Youth Wellness (CYW) measure: Parenting competence assessed with the Parenting Sense of Competence (PSOC) measure: Psychiatric symptom severity in parents assessed with the Brief Symptom Inventory (BSI) measure: Health related quality of life and functioning in parents assessed with the European Quality of life - 5 Dimensions (EQ-5D) measure: Parental mentalizing assessed with the Parental Reflective Functioning Questionnaire (PRFQ) measure: Mind-mindedness assessed with the Representational Mind-Mindedness (MM) interview measure: Epistemic trust assessed with the Epistemic Trust, Mistrust, and Credulity Ques-tionnaire (ETMCQ) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Psychotherapeutic Centre Stolpegaard status: RECRUITING city: Gentofte state: Capital Region zip: 2820 country: Denmark name: Emilie Hestbaek role: CONTACT phone: +4528302849 email: emilie.hestbaek.jacobsen@regionh.dk lat: 55.74903 lon: 12.54601 facility: Psychotherapeutic Centre Stolpegård status: RECRUITING city: Gentofte zip: 2820 country: Denmark name: Emilie Hestbaek, Msc in Psyc role: CONTACT phone: +4528302849 email: emilie.hestbaek.jacobsen@regionh.dk name: Sebastian Simonsen, Doctor role: CONTACT email: sebastian.simonsen@regionh.dk lat: 55.74903 lon: 12.54601 hasResults: False

 nctId: NCT06315101 id: K-2023-092 briefTitle: Effectiveness and Safety of Lenvatinib Combined With Chinese Herbal Medicine for Patients With Unresectable Hepatocellular Carcinoma: A Real-world Study in China overallStatus: COMPLETED date: 2023-09-01 date: 2023-12-31 date: 2023-12-31 date: 2024-03-18 date: 2024-03-18 name: Guangzhou University of Chinese Medicine class: OTHER briefSummary: This study aims to assess the effectiveness and safety of lenvatinib plus Chinese Herbal Medicine (CHM) for patients with uHCC in China. conditions: Unresectable Hepatocellular Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 142 type: ACTUAL name: Chinese Herbal Medicine measure: Efficacy outcomes measure: Survival analysis measure: Survival analysis measure: Adverse Events assessment sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the First Affiliated Hospital of Guangzhou University of Chinese Medicine city: Guangzhou state: Guangdong zip: 510407 country: China lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06315088 id: 69HCL24_0144 briefTitle: Food Biodiversity and Human Health acronym: BIOQUALIM overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2025-03-01 date: 2025-03-01 date: 2024-03-18 date: 2024-03-18 name: Hospices Civils de Lyon class: OTHER briefSummary: In Western countries, one of the major nutritional challenges requires reducing the proportion of animal proteins and increasing the proportion of vegetable proteins in the daily plate. Added to this nutritional challenge is an environmental challenge, with plant proteins being much less expensive to produce. However, plant proteins are mainly provided by cereals and legumes, a large diversity of which is necessary to cover the recommended daily intake of amino acids. However, given the collapse of cultivated biodiversity (loss of 75% in 100 years, FAO), the diversity of the supply is very reduced.

Furthermore, for several years, public health studies have indicated a chronic deficit in micronutrients (minerals/trace elements, vitamins, antioxidants) as well as fiber in the diet of the French population. This comes in particular from the impoverishment of the nutritional quality of the fruits/vegetables/cereals/legumes consumed. In general, diet plays a major role in the primary prevention of chronic diseases (cardiovascular, diabetes, cancer) including periodontal disease. Thus, a diet low in sugars, saturated fats and rich in fiber would reduce the appearance of periodontal disease by strengthening salivary capacity. However, certain pathogenic periodontal bacteria (such as Porphyromonas gingivalis) can migrate (blood, digestive or respiratory routes) to reach other organs and represent a risk factor for other chronic diseases. Thus, the prevention of periodontal diseases through diet control would also contribute to the prevention of other chronic diseases.

The benefit of plant-based diets to reduce the risk of cancer is now established. In addition, certain cereals such as spelled have superior nutritional qualities to common wheat, notably their protein content and they also contain higher quantities of certain bioactive compounds with anti-cancer properties (such as phytosterols).

Furthermore, the potential impact of the oral microbiota on chronic diseases is now being studied: in healthy adults, a dysbiotic periodontal microbiota may be likely to lead to systemic para-inflammation. It has also been shown that a dietary change (Mediterranean diet) could lead to a reduction in pathogenic bacteria in the oral microbiota (including P. gingivalis). However, the link between the introduction of cereals into the diet and the evolution of cancer risk factor bacteria in the oral microbiota has never been demonstrated.

This pilot clinical study plans to focus on the oral microbiota, with the aim of objectivizing a possible link between a modification of the diet by the introduction of cereals (einkorn type) and the evolution of certain bacteria of this microbiota. , notably P. gingivalis (but also T. forsythia, S. anginosus, A. actinomycetemcomitans, T. denticola and F. nucleatum), considered as cancer risk factors and thus observe an improvement in health status oral and general. conditions: Oral Microbiota conditions: Periodontal Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 10 type: ESTIMATED name: Einkorn Diet name: Intermediate oral microbiota name: Periodontal health status name: General health status measure: Total periodontal bacteria count measure: Intermediate periodontal bacteria count measure: Periodontal health analysis:plaque index measure: Periodontal health analysis: gingival index measure: Periodontal health analysis : pocket depth and loss of clinical attachment measure: Periodontal health analysis : interdental inflammation measure: Periodontal health analysis : salivary pH measure: General health analysis : body mass index measure: General health analysis : measurement of abdominal circumference measure: General health analysis : blood pressure measure: General health analysis : MOS SF-36 quality of life questionnaire measure: General health analysis : eating habits sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Maison des professionnels city: Lyon zip: 69000 country: France name: Bourgeois Denis, MD,PhD role: CONTACT phone: 04 27 85 40 00 email: denis.bourgeois@chu-lyon.fr lat: 45.74848 lon: 4.84669 hasResults: False

 nctId: NCT06315075 id: 657876 briefTitle: Dialectical Behavior Therapy for Adolescents With Self-harm and Suicidal Behavior- an Open Trial overallStatus: RECRUITING date: 2024-01-15 date: 2025-12-31 date: 2029-12-31 date: 2024-03-18 date: 2024-03-18 name: Haukeland University Hospital class: OTHER briefSummary: The goal of this pre-post-follow-up study is to examine how well the treatment Dialectical behavior therapy for adolescents (DBT-A) with a duration of 20 weeks for adolescents with self-harm and suicidal behavior works in routine clinical practice. The main questions it aims to answer are:

* to investigate how well DBT-A works after treatment and at 3-month follow-up, measured by episodes of self-harm, suicide attempts, depressive symptoms and quality of life, drop-out from treatment and number of possible participants who decline DBT-A.
* to investigate how well DBT-A works at 12 months follow-up
* to investigate whether pre-treatment factors can predict who will benefit from treatment conditions: Self-harm conditions: Suicidal Ideation conditions: Suicide and Self-harm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single group, uncontrolled, pre-post-one year follow-up study primaryPurpose: TREATMENT masking: NONE maskingDescription: An independent evaluator will assess participants at post treatment and one year follow-up. Due to the single group design, the assessor will be aware that participants have received the intervention, but will not be involved in recruitment and treatment. count: 140 type: ESTIMATED name: Dialectical behavior therapy for adolescents (DBT-A) measure: Lifetime Parasuicide Count Interview measure: Number of participants in need of emergency department visits caused by suicidal behavior measure: Depressive symptom score measured by Short Mood and Feelings questionnaire (SMFQ) measure: Health related quality of life measured by SCREENing for and Promotion of Health Related Quality of Life in Children an Adolescents (Kidscreen 10) measure: Barriers to Treatment Participation Scale (BTPS) score measure: Perceived benefit of skills training in DBT-A measured by a study specific questionnaire. sex: ALL minimumAge: 13 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Dept. of child and adolescent psychiatry, Haukeland University Hospital status: RECRUITING city: Bergen zip: 5021 country: Norway name: Gro Janne H. Wergeland, MD, PhD role: CONTACT phone: +47 48176828 email: gneh@helse-bergen.no name: Anne Mari Syversen, Psychol role: CONTACT phone: +4755975000 email: anne.mari.syversen@helse-bergen.no lat: 60.39299 lon: 5.32415 hasResults: False

 nctId: NCT06315062 id: CEC-UNIBE-07-2023 briefTitle: Efficacy of Rezum® in Reducing Prostate Volume overallStatus: COMPLETED date: 2020-01-01 date: 2022-12-31 date: 2023-12-31 date: 2024-03-18 date: 2024-03-18 name: Urología Costa Rica class: OTHER briefSummary: This study aimed to assess the efficacy of Rezum® water vapor therapy in reducing prostate volume in patients aged 40 years or older with Benign Prostate Hyperplasia (BPH) at UNIBE Hospital in Costa Rica. A retrospective analysis will be conducted on 289 patient records, focusing on prostate volume, International Prostate Symptom Score (IPSS), and urinary flow rate. Statistical analyses included two-sample mean comparisons, effect size estimation, and linear regression. conditions: Benign Hyperplasia of Prostate studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 289 type: ACTUAL measure: Prostate volume measure: International Prostate Symptome Score measure: Urinary flow rate sex: MALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital UNIBE city: San José zip: 11301 country: Costa Rica lat: 9.93333 lon: -84.08333 hasResults: False

 nctId: NCT06315049 id: 2023-ENFPOD-2621979 briefTitle: Music Therapy to Reduce Anxiety in Community-Dwelling Individuals With Severe Mental Illness overallStatus: COMPLETED date: 2023-06-26 date: 2023-07-31 date: 2023-07-31 date: 2024-03-18 date: 2024-03-18 name: Universitat Politècnica de València class: OTHER name: University of Valencia briefSummary: This study aims to measure the effectiveness of the Music Therapy nursing intervention in reducing anxiety in outpatients diagnosed with severe mental illness (SMI) (bipolar disorder and schizophrenia). The intervention was structured over five weeks (ten 1-hour sessions, twice weekly). Objective measures (blood pressure, heart rate, and respiratory rate) and subjective measures (anxiety response and the subjective perception of relaxation) were taken before and after every session. conditions: Severe Mental Disorder conditions: Schizophrenia conditions: Bipolar Disorder conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 14 type: ACTUAL name: Music therapy measure: IDARE test measure: SBP measure: DBP measure: HR measure: RR sex: ALL minimumAge: 35 Years maximumAge: 50 Years stdAges: ADULT facility: Universitat Politècnica de València city: Valencia zip: 46022 country: Spain lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06315036 id: 32/2021 briefTitle: Effects of Developmental Gymnastics on Preschoolers' Motor Skills acronym: GymKids overallStatus: COMPLETED date: 2021-09-05 date: 2021-09-10 date: 2022-05-10 date: 2024-03-18 date: 2024-03-18 name: University of Novi Sad class: OTHER briefSummary: Background: During childhood, physical activity (PA) is considered indispensable for developing motor skills through movement in the early stages of human development. Being active helps individuals develop fine and gross motor skills (GMS) by promoting an active lifestyle. Notably, this phase, characterized by regular PA and attaining motor competence, is associated with many health-related benefits. Early motor intervention programs have garnered attention for their positive influence on children's motor skills, as evidenced by various studies. A spectrum of more specialized methods is available alongside these general approaches, including programs designed to augment the time dedicated to general PA within school environments. Previous research has demonstrated the efficacy of incorporating experimental exercise interventions, grounded in enjoyable activities and game drills, into the curriculum, significantly improving children's basic motor skills. Many research articles have explored the impact of developmental gymnastics (DG) on children's fitness, indicating that gymnastics training can produce numerous beneficial outcomes for children's physical fitness.

Method and Materials: Three hundred preschool children were assigned to either a gender-balanced group participating in a DG exercise program (EG; n=99) or a control group (CG; n=121). While individuals in the CG followed three structured extracurricular physical activities per week in kindergarten, the EG participants received 60 minutes of the DG exercise program two days a week. The Test of Gross Motor Development-2 (TGMD-2) was used to assess GMS.

Aim: The study aimed to determine if participation in a structured DG program could improve GMS among preschool children compared to those in a group that attended extracurricular physical activities in a kindergarten. conditions: Motor Activity conditions: Child Development conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 300 type: ACTUAL name: Developmental gymnastics measure: Test of gross motor development (tgmd-2): Locomotor Skills - Run measure: Test of gross motor development (tgmd-2): Locomotor skills - Gallop measure: Test of gross motor development (tgmd-2): Locomotor skills - Hop measure: Test of gross motor development (tgmd-2): Locomotor skills - Leap measure: Test of gross motor development (tgmd-2): Locomotor skills - Horizontal jump measure: Test of gross motor development (tgmd-2): Locomotor skills - skip measure: Test of gross motor development (tgmd-2): Locomotor skills - slide measure: Test of gross motor development (tgmd-2): Object control skill- two-hand strike measure: Test of gross motor development (tgmd-2): Object control skill- stationary bounce measure: Test of gross motor development (tgmd-2): Object control skill- catch measure: Test of gross motor development (tgmd-2): Object control skill- kick measure: Test of gross motor development (tgmd-2): Object control skill- overhand throw measure: Test of gross motor development (tgmd-2): Object control skill- underhand roll measure: Sex measure: Date of birth measure: Weight measure: Height measure: Body Mass Index (BMI) measure: Adherence sex: ALL minimumAge: 4 Years maximumAge: 7 Years stdAges: CHILD facility: Faculty of sport and Physical Education, University of Novi Sad city: Novi Sad state: Vojvodina zip: 21000 country: Serbia lat: 45.25167 lon: 19.83694 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-07 uploadDate: 2024-03-13T15:29 filename: Prot_000.pdf size: 1944925 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2020-06-10 uploadDate: 2024-03-13T15:30 filename: ICF_001.pdf size: 147616 hasResults: False

 nctId: NCT06315023 id: CP-0029 briefTitle: The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry) acronym: PTAB1 overallStatus: ENROLLING_BY_INVITATION date: 2023-10-06 date: 2028-06-07 date: 2032-06-07 date: 2024-03-18 date: 2024-03-26 name: Endologix class: INDUSTRY name: Fivos name: Massachusetts General Hospital name: Society for Vascular Surgery Patient Safety Organization briefSummary: The purpose of this post-market surveillance study will be to evaluate the real-world use of the DETOUR System in treated patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis \> 70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. conditions: Peripheral Arterial Disease conditions: Symptomatic Femoropopliteal Lesions studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 450 type: ESTIMATED name: DETOUR System measure: Freedom from CD-TLR measure: Freedom from MAE sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Medical Center city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06315010 id: MedOPP662 id: CA127-1061 type: OTHER domain: Bristol-Myers Squibb GmbH & Co id: 2023-508112-35 type: EUDRACT_NUMBER briefTitle: REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis acronym: REPOSE overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2027-03 date: 2028-04 date: 2024-03-18 date: 2024-03-18 name: MedSIR class: OTHER name: Medical University of Vienna briefSummary: REPOSE is a phase II clinical trial exploring the safety and efficacy of repotrectinib in patients with non-small cell lung cancer (NSCLC) characterized by the presence of brain metastasis (BM) and whose tumors have mutated ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) gene. conditions: NSCLC conditions: Brain Metastases conditions: ROS1 Gene Rearrangement studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Repotrectinib measure: Intracranial Objective Response Rate (IC-ORR) measure: Clinical Benefit Rate (CBR) for intracranial (IC) lesions measure: Disease Control Rate (DCR) for IC lesions measure: Time to Response (TTR) for IC lesions measure: Duration of Response (DoR) for IC lesions measure: Objective Response Rate for extracranial (EC) and overall lesions (EC-ORR) measure: CBR for EC and overall lesions measure: DCR for EC and overall lesions measure: TTR for EC and overall lesions measure: DoR for EC and overall lesions measure: Best percentage of change in tumor burden measure: Progression-Free Survival (PFS) measure: Overall Survival (OS) measure: Neurologic function measure: Quality of life (QoL) with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) measure: QoL with the brain cancer specific questionnaire (QLQ-C20). measure: Safety and tolerability measure: Exploratory endpoint: Genetic studies using blood samples to investigate the potential association with clinical outcomes measure: Exploratory endpoint: ROS1 gene expression analysis using baseline tissue samples to investigate the potential association with clinical outcomes measure: Exploratory endpoint: Analysis of medical imaging to identify potential biomarkers associated with clinical outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06314997 id: 2013.34 briefTitle: Dynamic Changes in Circulating Tumour Cells Protein Expression acronym: Liquid-DRER2 overallStatus: RECRUITING date: 2019-01-14 date: 2024-12-17 date: 2027-12-18 date: 2024-03-18 date: 2024-03-18 name: Matteo's Friends class: OTHER briefSummary: This multicenter study, randomized, controlled of blood-based biomarker-driven targhet therapy. Patients were selectedm( at Hospital San Giovanni and Celio in Rome) according to CTCs results ( CTCs-guided managment performed at University Magna Graecia) or managed by the treating clinician according to standard pathological criteria (standard management). The participants were assigned to trial groups with the use of block randomization stratified according to the enrolling center location metropolitan) and tumor stage (T3 or T4). conditions: Recurrence Free Survival studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 150 type: ESTIMATED name: panitumumab (EGFR inhibitors) measure: The primary efficacy end point was recurrence- free survival at 12 months. sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Natalia Malara status: RECRUITING city: Germaneto zip: 88100 country: Italy lat: 38.88496 lon: 16.57673 hasResults: False

 nctId: NCT06314984 id: A10040521 briefTitle: Jet Injectors Versus Conventional Anesthetic Technique in Children overallStatus: COMPLETED date: 2021-07-21 date: 2022-11-15 date: 2023-03-21 date: 2024-03-18 date: 2024-03-18 name: Mansoura University class: OTHER briefSummary: This clinical study was conducted to compare the needleless Comfort-in jet injector device and the conventional needle technique in terms of

1. Pain level during the administration of local anesthesia in children.
2. Their effectiveness during pulpotomy procedures in primary molars.

Whether comfort-in jet injector device will achieve sufficient anesthesia for the procedures undertaken during pulpotomy or not when compared to the conventional technique and the pain levels of both techniques during the anesthesia step. conditions: Anesthesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 76 type: ACTUAL name: Group I A (Conventional needle syringe) name: Group I B (Conventional needle syringe) name: Group II A (Comfort-in Jet Injector) name: Group II B (Comfort-in Jet Injector) measure: Pain level during the administration of local anesthesia by Wong-Baker faces pain rating scale measure: Pain levels during pulpotomy procedures steps by Wong-Baker faces pain rating scale measure: Pain level during administration of local anesthesia in children by FLACC scale. measure: Pain levels during pulpotomy procedures steps by FLACC scale. sex: ALL minimumAge: 4 Years maximumAge: 7 Years stdAges: CHILD facility: Faculty of Dentistry, Mansoura University. city: Mansoura state: Dakahlia zip: 35516 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06314971 id: 23228/T1CR briefTitle: Predicting Local and Distant Recurrence in T1 Colorectal Cancer acronym: T1CR overallStatus: RECRUITING date: 2023-03-15 date: 2025-03-15 date: 2025-03-15 date: 2024-03-18 date: 2024-03-18 name: City of Hope Medical Center class: OTHER briefSummary: Tumor recurrence significantly affects survival rates following the local resection of submucosal colorectal cancers (T1 CRC). Despite this, there are currently no reliable biomarkers established to predict recurrence in T1 CRC.

This study seeks to improve the prediction of recurrence-free survival in individuals who have survived T1 CRC. conditions: Colorectal Cancer conditions: Colorectal Neoplasms conditions: Colorectal Adenocarcinoma conditions: Colorectal Cancer Stage I conditions: Colorectal Neoplasms Malignant conditions: Colorectal Cancer Recurrent studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED name: Tw1CE measure: Recurrence-free Survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope Medical Center status: RECRUITING city: Duarte state: California zip: 91010 country: United States name: Ajay Goel, PhD role: CONTACT phone: 626-218-3452 email: AJGOEL@COH.ORG name: Takayuki Noma, MD role: PRINCIPAL_INVESTIGATOR name: Alessandro Mannucci role: SUB_INVESTIGATOR name: Ajay Goel, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.13945 lon: -117.97729 facility: Tokushima University status: RECRUITING city: Tokushima country: Japan name: Mitsuo Shimada, PhD role: CONTACT email: mitsuo.shimada@tokushima-u.ac.jp name: Katsuki Miyazaki role: SUB_INVESTIGATOR name: Takayuki Noma, MD role: SUB_INVESTIGATOR name: Yuma Wada, PhD role: SUB_INVESTIGATOR name: Mistuo Shimada, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.06667 lon: 134.56667 facility: Barcelona University status: RECRUITING city: Barcelona country: Spain name: Maria Pellise role: CONTACT email: mpellise@clinic.cat name: Karmele Saez de Gordoa role: SUB_INVESTIGATOR name: María Daca role: SUB_INVESTIGATOR name: Francesc Balaguer role: PRINCIPAL_INVESTIGATOR name: Maria Pellise role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06314958 id: 23228/CENSURE briefTitle: Stage II/III Colorectal Cancer Recurrence acronym: CENSURE overallStatus: RECRUITING date: 2023-03-15 date: 2025-03-15 date: 2025-03-15 date: 2024-03-18 date: 2024-03-18 name: City of Hope Medical Center class: OTHER briefSummary: This study will develop an assay to predict disease recurrence in patients with stage II/III CRC after receiving adjuvant chemotherapy, using genome-wide DNA methylation. conditions: Colorectal Cancer conditions: Colorectal Adenocarcinoma conditions: Colorectal Cancer Stage II conditions: Colorectal Cancer Stage III conditions: Colorectal Cancer Recurrent studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: CENSURE measure: Recurrence-Free Survival measure: Overall Survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope Medical Center status: RECRUITING city: Monrovia state: California zip: 91016 country: United States name: Ajay Goel, PhD role: CONTACT phone: 626-218-3452 email: AJGOEL@COH.ORG name: Caiming Xu, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Ajay Goel, PhD role: PRINCIPAL_INVESTIGATOR name: Alessandro Mannucci, MD role: SUB_INVESTIGATOR lat: 34.14806 lon: -117.99895 facility: Second Affiliated Hospital of Dalian Medical University status: RECRUITING city: Dalian country: China name: Man Li role: CONTACT email: man_li@dmu.edu.cn name: Man Li role: PRINCIPAL_INVESTIGATOR lat: 38.91222 lon: 121.60222 facility: Barcelona University status: RECRUITING city: Barcelona country: Spain name: Francesc Balaguer, MD, PhD role: CONTACT email: fprunes@clinic.cat name: Francesc Balaguer, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: La Paz University Hospital status: RECRUITING city: Madrid country: Spain name: Marta Mendiola role: CONTACT email: marta.mendiola@salud.madrid.org name: Marta Mendiola role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06314945 id: #11280-4\12-2023 briefTitle: Diagnostic Value of Recto-perineal Ultrasound in Perianal Fistula overallStatus: COMPLETED date: 2023-09-01 date: 2024-03-01 date: 2024-03-01 date: 2024-03-18 date: 2024-03-18 name: Zagazig University class: OTHER_GOV briefSummary: Perianal fistula is a common anal problem. It needs only surgery. MRI is the best preoperative diagnostic tool, but it is demanding as it is expensive, time consuming and needs an experienced radiologist. So, we tried to find an alternative diagnostic tool which is cheaper, time saving and accurate and comparing its preoperative reports with intraoperative findings.

study was held in surgery department in Zagazig University Hospitals from September 2023 to March 2024. It included 93 patients with perianal fistula who were diagnosed clinically and radiological by trans recto-perineal ultrasound and comparing pre-operative ultrasound findings with intra-operative surgical findings. conditions: Perianal Fistula studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 93 type: ACTUAL measure: age measure: sex measure: body mass index measure: history of abscess drainage measure: Internal opening measure: fistula branches measure: type fistulous tract measure: abscess cavity measure: other anal disease measure: external openings measure: anal discharge sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zagazig University Hospitals city: Zagazig zip: 44519 country: Egypt lat: 30.58768 lon: 31.502 hasResults: False

 nctId: NCT06314932 id: spe123.23 briefTitle: Role of Ultra-processed Foods in Modulating the Effect of Mediterranean Diet acronym: PROMENADE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2025-06 date: 2024-03-18 date: 2024-03-18 name: University of Milan class: OTHER name: University of Florence name: University of Teramo briefSummary: Mediterranean diet is worldwide promoted as one of the healthiest and most sustainable dietary patterns. One of the main pillars of Mediterranean diet is the abundant consumption of plant-based ingredients typically consumed as raw or minimally processed. However, even in the Mediterranean countries, these fresh foods are increasingly replaced by ultra-processed foods (UPF). Epidemiological evidence suggests that consumption of UPF may be detrimental to human health, but there is only one clinical trial on this topic which is largely debated in the scientific community due to limitations related to the short duration of the trial and the composition of dietary interventions.

The present study aims at exploring whether the inclusion of UPF within a Mediterranean-based dietary pattern can impact on cardiometabolic markers, gut microbiota and other health markers in a dietary intervention performed in Italian subjects. For this purpose, 50 clinically healthy subjects will be recruited for a 7-month randomized, open, cross-over dietary trial. Eligible participants will be randomly assigned to consume a 3-month Mediterranean diet high in UPF (intervention group) or a low-UPF Mediterranean diet (control group), spaced by a 1-month wash-out period. The two diets will have the same composition in terms of food groups. However, in the high-UPF Mediterranean diet group, 5 servings/day of UPF, as defined by the NOVA system, will be consumed (e.g., flavored yogurt, breakfast cereals with added sugar, processed meat). In the control group, these foods will be replaced by products from the same food group, but not UPF (e.g., plain yogurt, breakfast cereals with no added sugar, unprocessed meat). The inflammatory potential of pairs of food products, both UPF and non UPF, will be evaluated using an in vitro cell model testing the modulation of inflammatory markers. Before and after each intervention blood, urine and fecal samples will be collected. The primary endpoint is change in low-density lipoprotein (LDL) cholesterol levels from baseline. Among the other markers, blood pressure and anthropometric parameters will be measured; biochemical parameters, adipokines, inflammatory and oxidative stress markers, fecal microbiota composition and short chain fatty acids (SCFAs) will be analyzed. Adherence to the study, dietary intake and food waste production will be evaluated through specific food diaries, useful also for estimating the metabolic food waste. conditions: Overweight studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: MD high in UPF name: MD low in UPF measure: Low-density lipoprotein (LDL) cholesterol levels measure: Total cholesterol levels measure: High-density lipoprotein (HDL) cholesterol levels measure: Triglycerides levels measure: Fasting blood glucose levels measure: Insulin levels measure: Aspartate aminotransferase (AST) levels measure: Alanine aminotransferase (ALT) levels measure: Gamma-glutamyl transferase (GGT) levels measure: Folates levels measure: Vitamin B12 levels measure: Urea levels measure: Creatinine levels measure: Body weight measure: Body mass index (BMI) measure: Fat mass measure: Concentration of ghrelin in plasma measure: Concentration of leptin in plasma measure: Concentration of adiponectin in plasma measure: Concentration of resistin in plasma measure: Concentration of visfatin in plasma measure: Concentration of interleukin (IL)-4 in plasma measure: Concentration of interleukin (IL)-6 in plasma measure: Concentration of interleukin (IL)-10 in plasma measure: Concentration of Protein C-reactive (PCR) in plasma measure: Concentration of interferon gamma (IFN-γ) in plasma measure: Concentration of tumor necrosis factor -alpha (TNF-α) in plasma measure: DNA damage expressed as number of DNA strand breaks induced by hydrogen peroxide (H2O2) measure: Concentration of F2-isoprostanes in urine measure: Gut microbiota composition and function changes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Florence city: Florence zip: 54141 country: Italy name: Monica Dinu role: CONTACT phone: +39 349 3465184 email: monica.dinu@unifi.it lat: 43.77925 lon: 11.24626 facility: University of Milan city: Milan zip: 20133 country: Italy name: Daniela Martini role: CONTACT phone: +39 02503 16727 email: daniela.martini@unimi.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06314919 id: BR-PEC-OS-401 briefTitle: A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib overallStatus: RECRUITING date: 2024-03-15 date: 2026-03 date: 2026-03 date: 2024-03-18 date: 2024-04-23 name: Boryung Pharmaceutical Co., Ltd class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of fixed-Dose combination of Pitavastatin/Ezetimibe under the real-world condition conditions: Primary Hypercholesterolemia conditions: Mixed Dyslipidemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 8606 type: ESTIMATED measure: Rate of reaching the target LDL Cholesterol level sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ewha Womans University Seoul Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Wook-Bum Pyun, M.D., Ph.D. role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06314906 id: SHLU-2024001 briefTitle: Electroacupuncture Plus Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer overallStatus: RECRUITING date: 2024-03-07 date: 2027-01-31 date: 2027-03-31 date: 2024-03-18 date: 2024-03-21 name: Feixue Song class: OTHER briefSummary: This study explores the effectiveness of combining electroacupuncture with olanzapine-containing four-drug antiemetic therapy to mitigate chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer. The research aims to assess the adjunctive benefits of electroacupuncture in enhancing the antiemetic effects of conventional medication, particularly in the context of highly emetogenic chemotherapy regimens. By investigating the synergistic potential of these modalities, the study seeks to provide insights into optimizing supportive care strategies for patients with breast cancer undergoing intensive chemotherapy treatment. conditions: Electroacupuncture conditions: Olanzapine-contained Four-drug Antiemetic conditions: Nausea and Vomiting studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 370 type: ESTIMATED name: Electroacupuncture name: Antiemetic Therapy name: Sham electroacupuncture name: Antiemetic Therapy measure: Proportion of Patients Free from Nausea Throughout Treatment sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Second Hospital of Lanzhou University status: RECRUITING city: Lanzhou state: Gansu zip: 730000 country: China name: Feixue Song, Dr role: CONTACT phone: 13639336037 email: 13639336037@139.com lat: 36.05701 lon: 103.83987 hasResults: False

 nctId: NCT06314893 id: LMCII2022-001 briefTitle: Establishing a Correlation Between HRM and UGI MM Studies acronym: MMvsMANO overallStatus: RECRUITING date: 2022-08-24 date: 2025-07 date: 2025-07 date: 2024-03-18 date: 2024-03-18 name: Lexington Health Incorporated class: OTHER briefSummary: A retrospective and prospective cohort, quantitative data collection with the goal of comparing preoperative High Resolution Manometry(HRM) results to Upper Gastrointestinal Marshmallow(UGI MM) results, in patients undergoing preoperative esophageal motility assessments. The aim of this study is to establish a correlation between HRM and UGI MM in order to create a clinically supported gold standard measurement for preoperative esophageal motility assessment. conditions: Esophageal Motility Disorders studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: Determining the correlation between HRM and UGI MM assessments among preoperative candidates will provide an evidenced based evaluation strategy for establishing procedural candidacy and predicting postoperative outcomes. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lexington Health Incorporated status: RECRUITING city: West Columbia state: South Carolina zip: 29169 country: United States name: Kimberly Pressley role: CONTACT phone: 803-935-8794 email: kmpressley@lexhealth.org name: Marc Antonetti, MD role: PRINCIPAL_INVESTIGATOR name: Lori Norris, APRN role: SUB_INVESTIGATOR name: Brandi O'Neal, RN,MSN role: SUB_INVESTIGATOR lat: 33.99349 lon: -81.07398 hasResults: False

 nctId: NCT06314880 id: 2022112701 briefTitle: Safety, Tolerability, and Immunogenicity of Recombinant Meningococcal Group B Vaccine (E.Coli) overallStatus: RECRUITING date: 2023-07-22 date: 2024-12-30 date: 2024-12-30 date: 2024-03-18 date: 2024-04-03 name: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd class: INDUSTRY briefSummary: The research objective is to evaluate the safety and tolerability of the recombinant Group B meningococcal vaccine (E. coli) and explore its preliminary immunogenicity. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose) name: Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose) name: Placebo control measure: The incidence rate of all AEs within 0-30 days after each dose of vaccination measure: The incidence rate of solicited AEs within 30 minutes after each dose of vaccination measure: The incidence rate of solicited AEs within 0-14 days after each dose of vaccination measure: The incidence rate of unsolicited AEs within 0-30 days after each dose of vaccination measure: The incidence rate of grade 3 and higher AEs within 0-30 days after each dose of vaccination sex: ALL minimumAge: 3 Months maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention status: RECRUITING city: Nanning state: Guangxi zip: 530028 country: China name: Lirong Huang role: CONTACT phone: +86-13978620932 lat: 22.81667 lon: 108.31667 hasResults: False

 nctId: NCT06314867 id: 20220231 briefTitle: Clinical Study on Lot-to-lot Consistency and Immune Persistence of Three Commercial Batches of PPSV23 overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-30 date: 2024-12-30 date: 2028-06-30 date: 2024-03-18 date: 2024-04-04 name: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd class: INDUSTRY briefSummary: The research objective is to evaluate lot-to-lot consistency and immune persistence of three commercial batches of 23 valent pneumococcal polysaccharide vaccine. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 990 type: ACTUAL name: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 1) name: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2) name: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3) measure: Geometric mean concentration (GMC) levels sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: Sichuan Center for Disease Control and Prevention city: Chengdu state: Sichuan zip: 610041 country: China lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06314854 id: P202300046 briefTitle: The Effect of Running Water Sound Listened to Patients During Hemodialysis overallStatus: RECRUITING date: 2023-12-15 date: 2024-03-15 date: 2024-03-15 date: 2024-03-18 date: 2024-03-18 name: Kırklareli University class: OTHER briefSummary: It is known that being in nature and the visual perception of nature positively affects an individual's mood and self-confidence (Bratman et al., 2012). Studies have reported that natural sounds have a positive effect in situations such as pain, anxiety, and stress (Arai et al., 2008; Thoma et al., 2018). This finding means that listening to natural sounds may be a simple and easily accessible intervention that can positively impact key human stress systems.

Although many non-pharmacological methods are used in the literature to reduce the invasive pain and anxiety experienced by hemodialysis (HD) patients during cannulation, the most popular recently; However, we aimed to determine the effect of the sound of running water, which we have not yet encountered in dialysis patients, on invasive pain and anxiety experienced during fistula access. conditions: Hemodialysis Patients studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE maskingDescription: he forms were collected by dialysis unit nurses who did not know the groups the patients were assigned to. Information and training on how to collect the forms were provided to the nurses by the secondco-author. The current study was therefore performed asan assessor-blinded randomized controlled trial whoMasked: OUTCOMES_ASSESSOR count: 74 type: ESTIMATED name: Running water sound measure: Pain Assessment measure: State and Trait Anxiety Assessment sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aas status: RECRUITING city: Kırklareli state: Center zip: 39000 country: Turkey name: Samet Sayilan role: CONTACT phone: 05079404528 email: sametsayilan@hotmail.com lat: 41.73508 lon: 27.22521 hasResults: False

 nctId: NCT06314841 id: LBG-AUVA briefTitle: Polytrauma and Resuscitation Impact on Innate Immunity acronym: PRIME overallStatus: TERMINATED date: 2017-06-01 date: 2022-01-01 date: 2022-01-01 date: 2024-03-18 date: 2024-03-18 name: Ludwig Boltzmann Gesellschaft class: OTHER name: AUVA briefSummary: Major trauma can lead to a dysregulated response to secondary infection. Severe injuries are accompanied by pro- and antiinflammatory changes that affect both adaptive and innate immunity. In this study we aim to assess cellular immuno-competence early during treatment in an attempt to identify signs of immuno-suppression. conditions: Wounds and Injuries studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 62 type: ACTUAL measure: Immunocompetence measure: Changes in cellular immuno-status measure: Release of extracellular vesicles and associated content measure: Platelet-leukocyte aggregates measure: Immunocompetence clusters sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Trauma Center Vienna, Meidling city: Vienna zip: 1120 country: Austria lat: 48.20849 lon: 16.37208 facility: Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, AUVA Trauma Research Center city: Vienna zip: 1200 country: Austria lat: 48.20849 lon: 16.37208 facility: Trauma Center Vienna, Lorenz Böhler city: Vienna zip: 1200 country: Austria lat: 48.20849 lon: 16.37208 hasResults: False

 nctId: NCT06314828 id: RJMty19-B-NHL002 briefTitle: A Tolerability, Safety and Efficacy Study of RJMty19 in Subjects With Relapsed or Refractory B-NHL overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2025-05-20 date: 2027-05-20 date: 2024-03-18 date: 2024-03-18 name: Guangdong Ruishun Biotech Co., Ltd class: INDUSTRY name: Ruijin Hospital name: Southern Medical University, China name: Beijing GoBroad Hospital briefSummary: This is a Phase 1, open-label, single-arm study to evaluate tolerability, safety and efficacy of RJMty19 in adult subjects with r/r B-NHL. conditions: B-cell Non-Hodgkin's Lymphoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: RJMty19 (CD19-CAR-DNT cells) measure: Dose-Limiting Toxicity (DLT) measure: Maximum Tolerated Dose (MTD) measure: Incidence of abnormalities measure: Pharmacokinetics (PK) indicator (Cmax) measure: Pharmacokinetics (PK) indicator (AUC) measure: Pharmacokinetics (PK) indicator (Tmax) measure: Pharmacokinetics (PK) indicator (T1/2) measure: Overall Response Rate measure: Disease Control Rate measure: Duration of Response measure: Progression Free Survival measure: Overall Survival measure: Overall Response Rate at 3 months sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06314815 id: Shouldice hospital briefTitle: Ilioinguinal-iliohypogastric Nerve Block Prior to Shouldice Inguinal Hernia Repair acronym: NBSS overallStatus: COMPLETED date: 2023-01-11 date: 2024-03-10 date: 2024-03-15 date: 2024-03-18 date: 2024-03-21 name: Shouldice Hospital class: OTHER briefSummary: The introduction of ilioinguinal-iliohypogastric nerve blocks into the preoperative care regimen at Shouldice Hospital for inguinal hernia repair marks a significant shift in pain management strategies. While Shouldice Hospital has traditionally not employed this technique, recent literature highlighting its potential benefits has prompted its trial within their patient population.

Research in this area, although limited, suggests promising outcomes. Studies such as those by Beaussier et al. (2005) and Nehra et al. (1995) have demonstrated decreased postoperative pain and opioid use, as well as increased mobility associated with the use of ilioinguinal-iliohypogastric nerve blocks. However, concerns such as orthostatic hypotension and rebound pain have also been noted, indicating the need for careful consideration and monitoring of potential adverse effects.

More recent studies, particularly those focusing on the Lichtenstein repair, have further supported the potential benefits of ilioinguinal-iliohypogastric nerve blocks. Kacmaz and Bolat (2020) found improved patient satisfaction, reduced opioid consumption, and shorter hospital stays associated with nerve block techniques. Additionally, the use of adjuncts such as dexamethasone has shown promise in reducing rebound pain and opioid requirements postoperatively.

The purpose of evaluating the use of ilioinguinal-iliohypogastric nerve blocks at Shouldice Hospital is multifaceted. Not only does it aim to enhance patient care and satisfaction by improving pain management strategies, but it also provides valuable insights for anesthetists and surgeons regarding the utility and efficacy of this technique within the context of inguinal hernia repair. Furthermore, the trial may facilitate the refinement of current practices, potentially leading to standardized protocols that optimize patient outcomes while minimizing adverse effects.

In summary, the introduction of ilioinguinal-iliohypogastric nerve blocks at Shouldice Hospital represents a proactive approach toward enhancing perioperative care for inguinal hernia patients. By leveraging emerging evidence and adapting to evolving clinical practices, the hospital stands to benefit from improved patient outcomes and potentially contribute to the advancement of pain management strategies in hernia surgery. conditions: Inguinal Hernia conditions: Pain, Postoperative studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 50 type: ACTUAL measure: Compare pain and pain medication use between patients receiving an ilioinguinal-iliohypogastric nerve block prior to hernia surgery with those who do not. measure: Evaluate the impact of the ilioinguinal-iliohypogastric nerve block on patients with pain conditions, mental health conditions, and substance use histories. measure: Determine sample size for future prospective trial. sex: ALL minimumAge: 16 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Shouldice hospital city: Thornhill state: Ontario zip: L3T 4A3 country: Canada hasResults: False

 nctId: NCT06314802 id: LCSR briefTitle: Learning Curve of the Shouldice Procedure acronym: LCSR overallStatus: RECRUITING date: 2024-03-11 date: 2024-05-11 date: 2024-06-10 date: 2024-03-18 date: 2024-03-18 name: Shouldice Hospital class: OTHER briefSummary: Hernia repair surgery is common, especially the Shouldice repair for primary inguinal hernias, which is considered a top-notch nonmesh technique. However, outcomes can vary, possibly due to differences in surgical skill and experience. Many surgeons are trained more in mesh repairs like the Lichtenstein technique, rather than nonmesh repairs like Shouldice.

Understanding a surgeon's learning curve-how many surgeries they need to do to become proficient-is crucial. Yet, there's not much research on this for the Shouldice repair. This project aims to fill that gap and improve surgeon education.

The study's goal is to find out how the learning curve affects Shouldice repair for primary inguinal hernias. They'll look at how operative time changes over a surgeon's first 300 repairs compared to their 900-1000th. They'll also check for complications and recurrence rates.

The study objectives are:

1. Explore the learning curve and factors affecting Shouldice repair.
2. Compare operative times between a surgeon's early and later surgeries.
3. Look at complications during the learning curve.
4. Determine how long training takes at Shouldice Hospital and the surgeons' previous experience.
5. Review recurrence rates between the first 300 and 900-1000 surgeries.

This research aims to give surgeons and the hernia community valuable insights into improving surgical techniques and patient outcomes. conditions: Groin Hernia conditions: Shouldice Procedure studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 1600 type: ESTIMATED name: no intervention measure: Operating time I measure: Operating time II measure: Operating time III sex: ALL minimumAge: 16 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Shouldice hospital status: RECRUITING city: Thornhill state: Ontario zip: L3T 4A3 country: Canada name: Christoph Paasch role: CONTACT phone: 9058891125 email: cpaasch@shouldice.com name: Marguerite Mainprize role: CONTACT phone: 9058891125 email: mmainprize@shouldice.com hasResults: False

 nctId: NCT06314789 id: G1201 briefTitle: The Use of Lung Ultrasonography in the Delivery Room in Neonates acronym: LUSIN overallStatus: ENROLLING_BY_INVITATION date: 2024-03-01 date: 2025-03-01 date: 2025-03-01 date: 2024-03-18 date: 2024-03-18 name: Kırıkkale University class: OTHER briefSummary: Lung ultrasonography has become frequently used in neonatal intensive care units because it is a diagnostic, useful, harmless, radiation-free, bedside, reproducible and practical method. (1, 2) In our clinic, lung ultrasonography imaging is performed in infants hospitalized with respiratory distress.

Lung ultrasonography is widely used especially in conditions that mainly cause respiratory distress such as respiratory distress syndrome (RDS), pneumonia, neonatal transient tachypnea (NTRT), congenital pneumonia, meconium aspiration syndrome and pneumothorax. (1, 2) The reliability and specificity of AUS imaging especially in the diagnosis of NTRT have been proven in many studies.

AUS imaging has become an objective value by scoring today. Images will be obtained using the linear probe of the device to be used for lung ultrasound and transferred to a cell phone, both lungs will be evaluated as three areas on the right and left (anterior upper, anterior lower and lateral) and scored separately. Anteriorly, the region between the anterior axillary line and the parasternal line is divided into two by the line passing through the nipple. Above is considered as the upper anterior region and below as the lower anterior region. The area in the middle of the anterior and posterior axillary line is evaluated as the lateral region. Each area is scored from 0 to 3 points. If A lines are present, 0 points are given, if there are more than 3 B lines in an area, 1 point is given, if B lines are very dense and there are no A lines, it is considered as white lung and 2 points are given. If there is a consolidation image on AUS, 3 points were given. The maximum total score was 18 (8,9) (Figure 1).

In this study, both AUS imaging and scoring will be performed in the delivery room within the first 30 minutes and AUS score evaluation will be performed at postnatal 2nd, 6th and 24th hours in the intensive care unit for inpatients and in the maternal ward for maternal patients. The hypothesis of this study is that newborns with high AUS scores will have high rates of respiratory morbidities and respiratory support in the neonatal unit. The primary aim of the study was to determine the role and importance of AUS scores measured in the delivery room in predicting respiratory morbidities of infants. The secondary aim was to investigate the value of the course of AUS scores at postnatal 2, 6 and 24 hours in predicting the respiratory prognosis of the newborn infant. conditions: Suspected Damage to Fetus From Other Disease in the Mother, Affecting Management of Mother, With Delivery conditions: Patient Death or Serious Disability Associated With A Haemolytic Reaction Due to the Administration of ABO-Incompatible Blood or Blood Products studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 112 type: ESTIMATED name: doing lung ultrasonography measure: LUS in delivery room measure: LUS in NICU or room sex: ALL minimumAge: 1 Minute maximumAge: 1 Month stdAges: CHILD facility: Kirikkale University city: Kirikkale country: Turkey lat: 39.84528 lon: 33.50639 hasResults: False

 nctId: NCT06314776 id: NEURO24 briefTitle: Whole-Body Vibration Therapy in the Gait of Children With Cerebral Palsy overallStatus: RECRUITING date: 2024-03-11 date: 2024-06-01 date: 2024-06-30 date: 2024-03-18 date: 2024-03-18 name: Universidad de Almeria class: OTHER briefSummary: Observation of the effect of vibration therapy on the gait of children with cerebral palsy and the analysis of their functional evolution conditions: Cerebral Palsy conditions: Neurologic Disorder conditions: Gait Disorders in Children conditions: Hemiplegia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 10 type: ESTIMATED name: Usual physiotherapy without Whole-Body Vibration name: Pre-Usual physiotherapy name: Post-Usual physiotherapy measure: Test Time Up and Go measure: Timed 10-Meter Walk Test measure: Gross Motor Function Measure sex: ALL minimumAge: 2 Years maximumAge: 11 Years stdAges: CHILD facility: María del Mar Sánchez-Joya status: RECRUITING city: Almería zip: 04120 country: Spain name: María del Mar Sánchez-Joya, PhD role: CONTACT name: Pilar Pérez Guillén role: SUB_INVESTIGATOR lat: 36.83814 lon: -2.45974 hasResults: False

 nctId: NCT06314763 id: ROSIE briefTitle: Rivaroxaban Sotorasib Interaction Study acronym: ROSIE overallStatus: RECRUITING date: 2023-11-09 date: 2024-11 date: 2024-11 date: 2024-03-18 date: 2024-03-18 name: Radboud University Medical Center class: OTHER name: Amgen briefSummary: Venous thromboembolic Events (VTEs) are common in lung cancer patients with an incidence of \>15%, requiring anticoagulant treatment or prophylaxis. Although direct acting oral anticoagulants (DOACs) are the agents of first choice due to ease and patient friendliness, these drugs are often avoided in cancer patients due to suspected pharmacokinetic drug-drug interactions with oncolytic drugs. Sotorasib is the first KRASG12C inhibitor that has been approved by the US \[FDA\] and EU \[EMA\] for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC. Sotorasib has a potential to cause CYP3A-mediated drug-drug interactions due to induction of CYP3A and inhibition of P-GP. Rivaroxaban is the most frequently prescribed DOAC in the Netherlands. As rivaroxaban is a substrate for this enzyme and efflux pump, sotorasib may increase or decrease the exposure to rivaroxaban and, thus, impact its benefit-to-risk ratio. To enable safe combination of sotorasib and rivaroxaban, it is pivotal to investigate the magnitude of the pharmacokinetic interaction between these drugs. conditions: Drug Drug Interaction Study studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: An open label single-sequence pharmacokinetic drug-drug interaction study. primaryPurpose: OTHER masking: NONE count: 22 type: ESTIMATED name: Rivaroxaban 20mg name: Sotorasib 960mg measure: The pharmacokinetics (AUC) of single dose rivaroxaban in presence and absence of 960 mg sotorasib at pharmacokinetic steady-state. measure: The pharmacokinetics (Cmax) of single dose rivaroxaban in presence and absence of 960 mg sotorasib at pharmacokinetic steady-state. measure: The pharmacokinetics (AUC) of sotorasib in healthy volunteers. measure: The pharmacokinetics (Cmax) of sotorasib in healthy volunteers. measure: Number of participants with treatment-related adverse events as assessed by CTCAE v6.0 measure: Pharmacokinetic variability in AUC of rivaroxaban. measure: Pharmacokinetic variability in Cmax of rivaroxaban. measure: Pharmacokinetic variability in AUC of sotorasib. measure: Pharmacokinetic variability in Cmax of sotorasib. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Radboud university medical centre status: RECRUITING city: Nijmegen country: Netherlands name: Rob ter Heine role: CONTACT email: R.terHeine@radboudumc.nl name: Rob ter Heine role: PRINCIPAL_INVESTIGATOR lat: 51.8425 lon: 5.85278 hasResults: False

 nctId: NCT06314750 id: 2023ZSLYEC-680 briefTitle: Deep Learning Based MRI Radiomics in Predicting the Clinical Risk of Locally Advanced Rectal Cancer overallStatus: ACTIVE_NOT_RECRUITING date: 2010-01-01 date: 2023-09-30 date: 2027-09-30 date: 2024-03-18 date: 2024-03-18 name: Sixth Affiliated Hospital, Sun Yat-sen University class: OTHER briefSummary: Neoadjuvant therapy is the standard diagnosis and treatment strategy for locally advanced rectal cancer defined by MRI in order to achieve tumor regression, thus affecting the selection of surgical strategy and circumferential margin, improving the safety of operation and the prognosis of patients. This study focused on the related clinical factors such as tumor regression before and after neoadjuvant therapy, combined with preoperative high-dimensional features such as radiomics, to predict the related factors of tumor regression of locally advanced rectal cancer, and validate it with multicenter. In order to develop an accurate model that can be applied to the real world and stratify the risk of locally advanced rectal cancer patients before treatment. conditions: Locally Advanced Rectal Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 186 type: ACTUAL measure: OS sex: ALL minimumAge: 20 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06314737 id: 2021ZSLYEC-192 briefTitle: Assessment of Efficacy of Neoadjuvant Therapy in Locally Advanced Rectal Cancer overallStatus: COMPLETED date: 2010-10-02 date: 2018-12-06 date: 2024-01-01 date: 2024-03-18 date: 2024-03-18 name: Sixth Affiliated Hospital, Sun Yat-sen University class: OTHER briefSummary: This study analyzed the efficacy differences between neoadjuvant therapy and direct surgical treatment in patients with locally advanced rectal cancer in the real world. The aim was to evaluate the impact of neoadjuvant therapy on overall survival, disease-free survival, and local recurrence-free survival in patients with locally advanced rectal cancer, explore the population benefiting most from neoadjuvant therapy, and provide evidence-based medicine for the benefits of neoadjuvant therapy in patients with colorectal cancer in the real world. conditions: Locally Advanced Rectal Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3515 type: ACTUAL measure: Overall Survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06314724 id: PRO-VZV-4006 briefTitle: Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Children Aged 12~15 Months in the Philippines overallStatus: ENROLLING_BY_INVITATION date: 2024-03-01 date: 2024-05-15 date: 2024-06-15 date: 2024-03-18 date: 2024-03-18 name: Sinovac (Dalian) Vaccine Technology Co., Ltd. class: INDUSTRY briefSummary: This is a Phase Ⅲ, randomized, double-blind, active-controlled study to assess the immunogenicity and safety of the varicella vaccine,Live (hereinafter referred to as "varicella vaccine")manufactured by Sinovac (Dalian) Vaccine Technology Co., LTD.(hereinafter referred to as "Sinovac"). conditions: Varicella studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 642 type: ESTIMATED name: Varicella Vaccine name: Varivax measure: Seroresponse rate of varicella-zoster virus (VZV) antibody measure: Geometric mean concentrations (GMCs) of VZV antibody measure: GMC of VZV antibody measure: seropositive rate measure: Geometric mean fold rise (GMFR) from before vaccination of VZV antibody measure: Incidence of adverse reactions within 0~42 days after vaccination measure: Incidence of adverse reactions within 0~14 days after vaccination measure: Incidence of serious adverse events (SAE) within 0~42 days after vaccination sex: ALL minimumAge: 12 Months maximumAge: 15 Months stdAges: CHILD facility: San Juan de Dios Educational Foundation, lnc. city: Pasay zip: 1300 country: Philippines lat: 14.53748 lon: 121.00144 facility: Cardinal Santos Medical Center city: San Juan City zip: 1502 country: Philippines lat: 14.6 lon: 121.0333 hasResults: False

 nctId: NCT06314711 id: Ex Vivo US for OPC briefTitle: Ex Vivo 3D-ultrasound for Oropharyngeal Cancer overallStatus: COMPLETED date: 2021-10-01 date: 2024-02-01 date: 2024-02-01 date: 2024-03-18 date: 2024-03-18 name: Rigshospitalet, Denmark class: OTHER briefSummary: Patients with biopsy-verified oropharyngeal squamous cell carcinoma or Human Papillomavirus (HPV)-positive unknown primary treated with transoral robotic surgery are included. Immediately post-operatively, freshly resected specimens are examined with ex vivo 3D ultrasound (US).

Ex vivo 3D US will be used to match US slices of the specimen with corresponding histopathology slices. The US slices will be reviewed by a panel of head and neck surgeons blinded to histopathology.

The primary aim is to explore perioperative ex vivo 3D US for oropharyngeal tumor detection, delineation from normal tissue, tumor size and volume, and margin assessment. conditions: Oropharyngeal Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ACTUAL name: Ultrasound measure: Fresh ex vivo US Tumor detection (blinded to histopathology) measure: Margin assessment (blinded to histopathology) measure: Fresh ex vivo US tumor volume (blinded to histopathology) measure: Fresh ex vivo US margin distance (blinded to histopathology) measure: Fresh ex vivo tumor visible on specimen mecrophoto (blinded to histopathology) measure: Fresh ex vivo US tumor volume (unblinded to histopathology) measure: Formalin-fixed ex vivo US tumor volume (unblinded to histopathology) measure: Fresh ex vivo US margin distance (unblinded to histopathology) measure: Formalin-fixed ex vivo US margin distance (unblinded to histopathology) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dept. of Otorhinolaryngology, Head & Neck Surg, Rigshospitalet city: Copenhagen zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06314698 id: IIT-2024-0011 briefTitle: Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2027-04-30 date: 2024-03-18 date: 2024-03-18 name: RenJi Hospital class: OTHER name: Shanghai JMT-Bio Inc. briefSummary: The purpose of this study is to determine if narlumosbart is non-inferior to denosumab in the treatment of bone diseases from multiple myeloma (MM). conditions: Multiple Myeloma conditions: Bone Diseases studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 478 type: ESTIMATED name: Narlumosbart name: Denosumab measure: Percent change from baseline in urinary N-terminal telopeptide of type 1 collagen corrected for urinary creatinine (uNTx/uCr) at week 13 measure: The proportion of subjects with a change in uNTx/uCr greater than 65% from baseline to week 13 measure: Time to first on-study skeletal related event measure: Percentage of participants with an on-study SRE at different time points measure: Time to first and subsequent on-study SRE measure: Percent changes of serum bone alkaline phosphatase (BALP) and serum C-terminal telopeptide of type 1 collagen (sCTX-I) measure: Overall Survival measure: Incidence and type of adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06314685 id: 2020040C-2 briefTitle: Immunogenicity and Safety of MCV4 in Volunteers Aged 6 Months-5 Years overallStatus: ACTIVE_NOT_RECRUITING date: 2021-12-10 date: 2024-08-30 date: 2024-08-30 date: 2024-03-18 date: 2024-04-03 name: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd class: INDUSTRY briefSummary: The purpose of this study is to evaluate the immunogenicity and safety of Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old. conditions: Healthy Population studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 2450 type: ACTUAL name: Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine name: Group A and C Meningococcal Polysaccharide Vaccine name: Group ACYW135 Meningococcal Polysaccharide Vaccine measure: Antibody positive conversion rate sex: ALL minimumAge: 6 Months maximumAge: 5 Years stdAges: CHILD facility: Hunan Center for Disease Control and Prevention city: Changsha state: Hunan zip: 410005 country: China lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06314672 id: OSU-22318 id: NCI-2023-02217 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: U01CA274999 type: NIH link: https://reporter.nih.gov/quickSearch/U01CA274999 briefTitle: Outreach Project to Connect Underrepresented Populations to Clinical Trials at Ohio State University, CUSP2CT Project Trial overallStatus: RECRUITING date: 2023-08-22 date: 2024-12-31 date: 2025-12-31 date: 2024-03-18 date: 2024-03-18 name: Ohio State University Comprehensive Cancer Center class: OTHER name: National Cancer Institute (NCI) briefSummary: This clinical trial tests the impact of the The Ohio State University Connecting Underrepresented Populations to Clinical Trials (CUSP2CT) project on clinical trial referrals and enrollment in racial/ethnic minorities. Progress in cancer prevention, detection and treatment can only be made by identifying and validating new and improved methods, compounds and modalities in clinical trials. Unfortunately, participation in clinical trials is not equal across all racial and ethnic groups, limiting progress against cancer in all population groups and further widening the disparity gap. To change this picture, concerted effort needs to be directed both at the communities at risk for being left out of trials and the systems that cause the disparities at all levels involved in accrual to clinical trials. The CUSP2CT project may have the potential to increase referral and accrual of racial/ethnic minorities to prevention/control and treatment trials. conditions: Hematopoietic and Lymphoid System Neoplasm conditions: Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 208 type: ESTIMATED name: Accrual name: Discussion name: Educational Activity name: Interview name: Review name: Survey Administration measure: Change in referral to clinical trials (CTs) (short-term outcomes) measure: Change in accrual of minorities to CTs (short-term outcomes) measure: CT accrual and retention due to patient navigation (short-term outcomes) measure: Identification of program gaps in trial accrual (long-term outcomes) measure: Uptake of program in other clinics (long-germ outcomes) measure: Probability of trial enrollment and retention sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio State University Comprehensive Cancer Center status: RECRUITING city: Columbus state: Ohio zip: 43210 country: United States name: Electra D. Paskett, PhD role: CONTACT phone: 614-293-3917 email: electra.paskett@osumc.edu name: Electra D. Paskett, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06314659 id: 2020020C briefTitle: Immunogenicity and Safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in Volunteers Aged 3-5 Months overallStatus: ACTIVE_NOT_RECRUITING date: 2021-09-17 date: 2024-12-30 date: 2024-12-30 date: 2024-03-18 date: 2024-04-03 name: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd class: INDUSTRY briefSummary: The purpose of this study is to evaluate the immunogenicity and safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 to 5 months old. conditions: Healthy Population studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 630 type: ACTUAL name: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Zhifei Lvzhu) name: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Walvax) name: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Olymvax) measure: Analysis of antibody positivity conversion rate of serogroup A measure: Analysis of antibody positivity conversion rate of serogroup C sex: ALL minimumAge: 3 Months maximumAge: 5 Months stdAges: CHILD facility: Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention city: Nanning state: Guangxi zip: 530028 country: China lat: 22.81667 lon: 108.31667 hasResults: False

 nctId: NCT06314646 id: 3747 briefTitle: Transanal Transection and Single-stapled Anastomosis (TTSS) in Rectal Cancer Patients acronym: TTSS-REC overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2027-05-31 date: 2027-12-31 date: 2024-03-18 date: 2024-03-20 name: Istituto Clinico Humanitas class: OTHER briefSummary: The Transanal Transection and Single-Stapled anastomosis (TTSS) technique may be a valid alternative to traditional double-stapled anastomosis for low rectal cancer surgery. This study aims to compare the postoperative and functional outcomes of patients receiving TTSS and traditional double-stapled anastomosis. conditions: Rectal Cancer conditions: Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 472 type: ESTIMATED name: Transanal Transection and Single-Stapled anastomosis (TTSS) name: Double-stapled Total Mesorectal Excision (TME) measure: Rate of anastomotic leak measure: Rate of postoperative complications measure: Postoperative Recovery Profile (PRP) score measure: Proportion of patients fit for stoma closure measure: Healthcare costs measure: Low Anterior Resection Syndrome (LARS) score measure: Low Anterior Resection Syndrome (LARS) score measure: Low Anterior Resection Syndrome (LARS) score measure: Cancer recurrence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06314633 id: ICO-2023-13 briefTitle: Socioeconomic Determinants of the Chemical Exposome and Its Genotoxic Effects in Children acronym: PESTIFOL overallStatus: RECRUITING date: 2024-01-29 date: 2026-01 date: 2026-06 date: 2024-03-18 date: 2024-03-21 name: Institut Cancerologie de l'Ouest class: OTHER name: ANSES briefSummary: PESTIFOL will include children over 8 and under 12 years old of different socioeconomic positions (SEP), mostly living in the region of Pays de la Loire. This approach should enable us to assess the impact of the SEP, and therefore social inequalities, on chemical expositions and DNA damage, and to characterize which (classes/mixture of) pollutants are major source of DNA damage. The study will also address potential effects associated with geographical location on the exposome and its biological consequences. conditions: Healthy Volunteer Children studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Hair collection and parents questionnaires primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 140 type: ESTIMATED name: Hair cut name: Socio-economic questionnaires measure: Describe DNA damage measure: Describe DNA damage measure: Describe socio-economic characteristics. measure: Describe socio-economic characteristics. measure: Characterize chemical exposome variations measure: Characterize chemical exposome variations measure: Characterize socio-economic indicators measure: Characterize socio-economic indicators, geographical area, seasons measure: Characterize socio-economic indicators, geographical area, seasons measure: Characterize socio-economic indicators, geographical area, seasons measure: Describe DNA damage measure: Describe DNA damage sex: ALL minimumAge: 8 Years maximumAge: 12 Years stdAges: CHILD facility: Institut de Cancérologie de l'ouest status: RECRUITING city: Saint-Herblain zip: 44800 country: France name: Marie ROBERT, MD role: CONTACT email: Marie.Robert@ico.unicancer.fr name: Pierre VIDI, PhD role: CONTACT email: Pierre.Vidi@ico.unicancer.fr name: Marie ROBERT, MD role: PRINCIPAL_INVESTIGATOR name: PIERRE VIDI, PhD role: SUB_INVESTIGATOR name: Martine BELLANGER, PhD role: SUB_INVESTIGATOR lat: 47.21765 lon: -1.64841 hasResults: False

 nctId: NCT06314620 id: FF-2024-043 briefTitle: Normal Saline Flushing With And Without Heparin Lock In Maintaining Small Bore Intercostal Chest Catheter (ICC) Patency acronym: SENSHIP overallStatus: RECRUITING date: 2024-03-15 date: 2027-03-01 date: 2027-06-01 date: 2024-03-18 date: 2024-03-26 name: National University of Malaysia class: OTHER briefSummary: Pleural diseases are among the most common clinical problems encountered in healthcare settings in Malaysia and even worldwide. Most patients presented in a hospital setting with pleural diseases will need pleural aspirations or thoracentesis and chest drains for a variety of reasons. Healthcare providers will often be exposed to patients requiring pleural drainage hence it is important to be aware of safe techniques and procedures of insertion and also maintaining the pleural drainage systems to yield beneficial results.

Most often, smaller catheters were deemed to be less effective in view of slower drainage rates and associated with high risk of blockage. However presently , in tertiary hospital settings small bore intercostal chest catheters (SBICC) have become an alternative to large bore intercostal catheters (LBICC). SBICC has been found to be equally effective, less painful and easily tolerated by patients. Hence, proper maintenance of SBICC should be undertaken to reduce rates of occlusion and to yield most benefits from the pleural aspirations procedures.

British Thoracic Society in their latest guidelines recommends the use of small bore intercostal chest drain as the first choice in draining pleural effusions.

The success of draining pleural effusions with a SBICC has shown variable rates of success among different studies conducted. Most common issues faced are drain blockage and drain dislodgement.

There is limited data comparing the use of normal saline flushing versus fibrinolytic drug lock in maintaining patency of small bore intercostal chest drains in draining pleural effusions. This has lead us in conducting this research to compare the rates of partial or complete occlusions among normal saline flush with and without heparin saline lock in maintaining the patency of small bore intercostal chest catheter among patients with pleural diseases in Hospital Canselor Tuanku Muhriz, UKM requiring chest drains insertion. conditions: Pleural Effusion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: Heparin saline lock name: Without heparin saline lock measure: To compare the rate (in percentage) of occlusions of intercostal chest catheter in participants underwent normal saline flushing with and without heparin lock measure: To determine the onset of intercostal chest catheter occlusions (in hours) measure: To determine the change of hemoglobin (in g/dL) post ICC insertion measure: To determine the change of platelet (in 10 9/L) post ICC insertion measure: To determine the adverse effects of heparin saline lock measure: To assess the number of fenestrations occluded (in numbers from 0-5) with fibrin or blood clots sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: National University of Malaysia status: RECRUITING city: Kuala Lumpur state: Wilayah Persekutuan zip: 53300 country: Malaysia name: Mohamed Faisal Abdul Hamid role: CONTACT phone: 0391455555 phoneExt: 6082 email: faisal.hamid@ppukm.ukm.edu.my lat: 3.1412 lon: 101.68653 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2024-02-17 uploadDate: 2024-03-13T04:03 filename: Prot_SAP_ICF_000.pdf size: 521443 hasResults: False

 nctId: NCT06314607 id: APHP220498 briefTitle: Genetic and Molecular Characterization of Nervous System Lesions acronym: ONCONEUROTEK 2 overallStatus: RECRUITING date: 2024-03-26 date: 2034-03 date: 2034-03 date: 2024-03-18 date: 2024-04-29 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Primary and secondary brain tumors, the leading cause of death from cancer before the age of 35, represent a complex and heterogeneous group of pathologies with a generally poor prognosis. Knowledge of these tumors has made enormous strides thanks to access to biological samples, leading to a much more robust, reliable and precise histo-pronostic classification, but also, increasingly, to the identification of theranostic targets.

Despite these advances, there is a real need to refine diagnostic and prognostic classification, identify the biological mechanisms involved in the formation and progression of these pathologies, develop new targeted strategies, and devise minimally invasive follow-up methods (liquid biopsies).

In addition, certain non-tumoral brain lesions (e.g. malformations) can be similarly classified according to their molecular and mutational profile.

This project aims to make a decisive contribution to these objectives. conditions: Brain Tumor conditions: Brain Lesion (General) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 10000 type: ESTIMATED name: Prospective Biological Collection name: Retrospective Biological Collection measure: Study the clinical markers with the evolution of brain lesions. measure: Study the biological markers with the evolution of brain lesions. measure: Study the anatomopathological markers with the evolution of brain lesions. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Service de Neurochirurgie - Hôpital de la Pitié Salpêtrière status: RECRUITING city: Paris zip: 75013 country: France name: Bertand Mathon, Dr role: CONTACT phone: 01 84 82 73 63 phoneExt: +33 email: bertrand.mathon@aphp.fr lat: 48.85341 lon: 2.3488 facility: Service de Neurologie 2 -Hôpital de la Pitié Salpêtrière status: RECRUITING city: Paris zip: 75013 country: France name: Marc Sanson, Prof role: CONTACT phone: 01 42 16 03 91 phoneExt: +33 email: marc.sanson@aphp.fr lat: 48.85341 lon: 2.3488 facility: Service de Radiothérapie - Hôpital de la Pittié Salpêtrière status: NOT_YET_RECRUITING city: Paris zip: 75013 country: France name: Julian Jacob, Dr role: CONTACT phone: 01 84 82 74 90 phoneExt: +33 email: julian.jacob@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06314594 id: 2024KY920 briefTitle: the Individualized Stepwise Treatment Mode of Adolescent Idiopathic Scoliosis overallStatus: RECRUITING date: 2023-12-20 date: 2025-12-01 date: 2026-12-01 date: 2024-03-18 date: 2024-03-18 name: Hangzhou Medical College class: OTHER briefSummary: Based on the risk factors affecting adolescent scoliosis found in the previous social survey, this project adopts the paradigm based on transfer learning and semi-supervised learning, and uses mathematical methods such as multiple learning methods and Transformer image classification algorithms to develop and verify the early warning model and stepped treatment model of adolescent scoliosis, and conducts cost-effect analysis. conditions: Adolescent Scoliosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: Conventional treatment name: intervention treatment measure: Number of Cobb angles measure: Accuracy of new screening modalities measure: Hamilton Depression Volume sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College. status: RECRUITING city: Hangzhou state: Zhejiang zip: 311000 country: China name: Xinyun Dr LI, Doctor role: CONTACT phone: 8618069783240 email: lxyjasmine2010@163.com lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06314581 id: 673_BPPV-Teaching briefTitle: Effect of a Multifaceted Educational Intervention on the Implementation of Evidence-based Practices for Benign Paroxysmal Positional Vertigo in an Emergency Department acronym: BPPV-Teaching overallStatus: RECRUITING date: 2023-05-01 date: 2024-05-01 date: 2024-12-01 date: 2024-03-18 date: 2024-03-18 name: Fondation Hôpital Saint-Joseph class: OTHER briefSummary: Acute vertigo accounts for around 4% of emergency room visits. Triggered episodic vestibular syndrome is the most commonly encountered symptomatic context. BPPV (Benign Paroxysmal Positional Vertigo) is the main cause, representing 40-50% of the vertigo cases assessed in emergency departments. It results from the migration of calcium carbonate particles (otoliths), from the sticky membrane of the utricle and saccule of the inner ear, to one of the 3 semicircular canals (SCC), posterior, horizontal or lateral, and anterior. It occurs idiopathically with head movement, through degeneration, or following head trauma. The otolith impulse causes the endolymph to move, temporarily and aberrantly displacing the cup of the affected canal, resulting in the transmission of erroneous information to the vestibular nuclei. This leads to the sudden onset of vertigo and eye deviation, resulting in transient nystagmus. The location of the displaced otoliths determines the variant of BPPV: BPPV of the posterior semicircular canal is the most common (around 65% of BPPVs), followed by BPPV of the horizontal canal, while BPPV of the anterior canal is rare, as it resolves spontaneously and rapidly. Although a benign condition, BPPV leads 9 times out of 10 to a medical consultation, interruption of daily activities, or sick leave. Untreated, it will usually recur, and can impact on patients' quality of life. conditions: Benign Paroxysmal Positional Vertigo studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 185 type: ESTIMATED measure: accurate BPPV diagnostics measure: therapeutic maneuvers performed measure: Satisfaction of clinicians who received the educational interventio sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Groupe Hospitalier Paris Saint-Joseph status: RECRUITING city: Paris zip: 75014 country: France name: Camille GERLIER, MD role: CONTACT phone: +331441228023 email: cgerlier@ghpsj.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06314568 id: 6350 briefTitle: Radiochemotherapy and Interventional Radiotherapy in Vaginal Cancer acronym: TRIDENT overallStatus: RECRUITING date: 2024-03-15 date: 2026-03-31 date: 2028-12-31 date: 2024-03-18 date: 2024-04-04 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Prospective observational multicenter study, aimed at evaluating the effectiveness on local control and cancer-specific survival of radiochemotherapy followed by interventional radiotherapy in patients affected by vaginal cancer conditions: Vaginal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 278 type: ESTIMATED name: Radiochemotherapy plus interventional radiotherapy measure: Local Control measure: Cancer specific overall survival measure: Toxicities measure: Overall survivall measure: Disease free survivall measure: Metastasis free survival measure: Changes in quality of life over time sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS status: RECRUITING city: Roma zip: 00168 country: Italy name: VALENTINA LANCELLOTTA role: CONTACT phone: +390630155701 email: valentina.lancellotta@policlinicogemelli.it name: VALENTINA LANCELLOTTA role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06314555 id: CEROG2023 briefTitle: Impact of the sFlt-1/PlGF Ratio on Medical Decision-making and on Maternal and Neonatal Outcomes in Women Suspected of Preeclampsia overallStatus: COMPLETED date: 2019-10-01 date: 2021-01-27 date: 2021-01-27 date: 2024-03-18 date: 2024-03-18 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: Previous studies demonstrated that Placental Growth Factor (PIGF) and Vascular Endothelial Growth Factor (VEGF) produced by trophoblast cells decreases during Preeclampsia, whereas soluble fms-like tyrosine kinase-1 (sFlt-1), an antiangiogenic factor, increases. The ratio sFlt-1/PlGF has a higher positive predictive value than the isolated measurement. A ratio under 38 exclude risk of imminent preeclampsia and allows to outpatient follow-up with a negative predictive value of 99.3%. A ratio equal or higher than 38 permits to direct high-risk patients towards hospitalization with a positive predictive value of 36.7% of preeclampsia at 4 weeks. These findings suggest that the ratio can be used to select more appropriately women needing hospitalization for suspected preeclampsia. conditions: Preeclampsia Possible studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 314 type: ACTUAL name: Blood sample name: Vascular-renal sample measure: Doctor's medical care decisions on Hospitalization measure: Intensive monitoring measure: Corticosteroid administration for lung maturation measure: Birth induction sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Saint Etienne city: St Etienne zip: 42100 country: France lat: 45.43389 lon: 4.39 hasResults: False

 nctId: NCT06314542 id: REC-001 briefTitle: Quantitative Evaluation of the Impact of Relaxing Eligibility Criteria for Lung Cancer Based on Real-world Data overallStatus: RECRUITING date: 2013-01-01 date: 2025-12-31 date: 2026-06-30 date: 2024-03-18 date: 2024-03-18 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER name: AstraZeneca briefSummary: Eligibility criteria for cancer drug trials are generally too stringent, leading to key issues such as low enrolment rates and lack of population diversity. In order to evaluate the REC of NSCLC drug trials, this study will use deep learning methods to construct a structured real-world database of NSCLC across dimensions, and quantitatively assess the independent contribution of changes in each eligibility criterion to patient numbers, clinical efficacy and safety. conditions: Lung Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 50000 type: ESTIMATED name: relaxing eligibility criteria measure: Scale of eligibility criteria sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital, Chinese Academy of Medical Sciences status: RECRUITING city: Beijing country: China name: Ning Li role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06314529 id: 2022-LTF-BHC001 briefTitle: Long-term Follow-up Study of BHC001 for TDT overallStatus: RECRUITING date: 2022-12-14 date: 2036-12-10 date: 2037-05-10 date: 2024-03-18 date: 2024-03-18 name: Bioray Laboratories class: INDUSTRY name: The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army name: Xiangya Hospital of Central South University briefSummary: Observe long-term safety risk and long-term efficacy after intravenous infusion of BHC001 in TDT subjects. conditions: Thalassemia, Beta studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 6 type: ESTIMATED name: Assessments measure: Incidence of hematologic malignancies measure: Frequency, grade, and relationship of SAEs sex: ALL minimumAge: 5 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army status: RECRUITING city: Nanning state: Guangxi zip: 530021 country: China name: Xinhua Zhang, PhD role: CONTACT lat: 22.81667 lon: 108.31667 facility: Xiangya Hospital of Central South University status: RECRUITING city: Changsha state: Hunan zip: 510510 country: China name: Bin Fu, PhD role: CONTACT lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06314516 id: CRP17122 briefTitle: Influence of Nutrition and Sarcopenia on Esophageal Cancer Outcomes acronym: INSPECT overallStatus: COMPLETED date: 2017-12-27 date: 2024-02-28 date: 2024-02-28 date: 2024-03-18 date: 2024-03-18 name: Benaroya Research Institute class: OTHER name: Imperial College London briefSummary: Prospective multicenter longitudinal (observational) study recruiting from tertiary centers for the surgical management of esophageal cancer; Virginia Mason Medical Center (Seattle, USA) and St Mary's Hospital (Imperial College, London, UK). This is intended to be a pilot study. conditions: Esophageal Cancer conditions: Sarcopenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1717 type: ACTUAL measure: Longitudinal variation in body composition measure: Patient and disease-specific factors sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Virginia Mason Medical Center city: Seattle state: Washington zip: 98101 country: United States lat: 47.60621 lon: -122.33207 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2019-12-10 uploadDate: 2024-03-11T13:52 filename: Prot_000.pdf size: 1135477 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2019-01-15 uploadDate: 2024-03-11T13:53 filename: ICF_001.pdf size: 135983 hasResults: False

 nctId: NCT06314503 id: 23-075_CORDIAL_FIH id: NL83843.000.23 type: OTHER domain: CCMO (Centrale Commissie Mensgebonden Onderzoek) briefTitle: First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients acronym: CORDIAL overallStatus: RECRUITING date: 2024-01-22 date: 2024-12-31 date: 2024-12-31 date: 2024-03-18 date: 2024-03-18 name: UMC Utrecht class: OTHER name: European Commission, Horizon 2020 name: Dutch Kidney Foundation name: Health Holland name: Nanodialysis Ltd name: Università degli studi di Modena e Reggio Emilia (UNIMORE) name: Servicio Madrileno De Salud (SERMAS) name: PPI Healthcare Consulting Ltd briefSummary: The goal of this first-in-human clinical trial is to examine the safety and efficacy of treatment with a new peritoneal dialysis (PD) device called WEAKID (WEarable Artificial KIDney for peritoneal dialysis). This device, unlike conventional PD, allows for continuous flow of dialysate inside the abdominal cavity combined with continuous regeneration of spent dialysate thanks to sorbents that remove toxins from the fluid.

The study will include PD patients of 18 years or older with a well-functioning peritoneal catheter and no history of a PD-related infection for at least eight weeks prior to enrolment.

The main purpose of this study is to assess the (short-term) safety of the WEAKID system in a limited number (n=12) of patients and sessions.

Participants will undergo six treatment sessions (of four or eight hours) in total over a period of two weeks, either with or without a sorbent chamber.

Participants will be asked to collect urine and dialysate the week before the first treatment and during the treatment days. In addition, blood samples will be collected before and during the treatment weeks in order to compare the effects of conventional PD with that of WEAKID treatment. A peritoneal equilibrium test will also be done before and after the treatment weeks to test the function of the lining of the abdomen (the peritoneal membrane). conditions: Renal Insufficiency, Chronic conditions: Kidney Failure, Chronic conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study has a first-in-human, prospective, open-label, non-randomized, three-center, single-arm design. primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: WEAKID measure: Serious adverse device effects (SADEs) and device deficiencies (DDs) measure: Critical changes in blood pressure measure: Critical changes in heart rate measure: Critical changes in body temperature measure: Critical changes in oxygen saturation measure: Critical changes in plasma potassium measure: Critical changes in plasma calcium measure: Critical changes in plasma bicarbonate measure: Critical changes in intra-abdominal dialysate volume measure: Critical changes in intra-abdominal pressure measure: Adverse events (AEs) and device deficiencies (DDs) measure: Number of WEAKID treatments measure: Duration of WEAKID treatments measure: Dialysate flow rates during WEAKID treatment measure: Evolution of blood pressure measure: Evolution of heart rate measure: Evolution of body temperature measure: Evolution of oxygen saturation measure: Ultrafiltration volume measure: Peak glucose concentration in the device effluent measure: Ultrafiltration efficiency measure: Removal of urea by the WEAKID system measure: Removal of creatinine by the WEAKID system measure: Removal of phosphate by the WEAKID system measure: Removal of potassium by the WEAKID system measure: Removal of uric acid by the WEAKID system measure: Removal of beta-2 microglobulin by the WEAKID system measure: Removal of vitamin B12 by the WEAKID system measure: Mass transfer area coefficient of urea measure: Mass transfer area coefficient of creatinine measure: Mass transfer area coefficient of phosphate measure: Mass transfer area coefficient of potassium measure: Mass transfer area coefficient of uric acid measure: Mass transfer area coefficient of beta-2 microglobulin measure: Mass transfer area coefficient of vitamin B12 measure: Plasma clearance of urea measure: Plasma clearance of creatinine measure: Plasma clearance of phosphate measure: Plasma clearance of potassium measure: Plasma clearance of uric acid measure: Plasma clearance of beta-2 microglobulin measure: Plasma clearance of vitamin B12 measure: The plasma reduction ratio of the protein-bound uremic toxin p-cresyl sulfate measure: The plasma reduction ratio of the protein-bound uremic toxin p-cresyl glucuronide measure: The plasma reduction ratio of the protein-bound uremic toxin indole acetic acid measure: The plasma reduction ratio of the protein-bound uremic toxin kynurenine measure: The plasma reduction ratio of the protein-bound uremic toxin kynurenic acid measure: The plasma reduction ratio of the protein-bound uremic toxin hippuric acid measure: The release of base measure: Evolution of plasma levels of urea measure: Evolution of plasma levels of creatinine measure: Evolution of plasma levels of uric acid measure: Evolution of plasma levels of beta-2 microglobulin measure: Evolution of plasma levels of phosphate measure: Evolution of plasma levels of potassium measure: Evolution of plasma levels of bicarbonate measure: Evolution of plasma levels of lactate measure: Evolution of plasma levels of sodium measure: Evolution of plasma levels of chloride measure: Evolution of plasma levels of calcium measure: Evolution of plasma levels of magnesium measure: Evolution of plasma levels of glucose measure: Evolution of plasma levels of lactate dehydrogenase measure: Evolution of plasma levels of vitamin B12 measure: Evolution of plasma levels of albumin measure: Evolution of plasma leucocyte count measure: Evolution of plasma thrombocyte count measure: Evolution of plasma levels of C-reactive protein (CRP) measure: Evolution of plasma levels of bilirubin measure: Evolution of plasma levels of aspartate transaminase (ASAT) measure: Evolution of plasma levels of alanine aminotransferase (ALAT) measure: Evolution of sodium levels in dialysate effluent measure: Evolution of chloride levels in dialysate effluent measure: Evolution of calcium levels in dialysate effluent measure: Evolution of magnesium levels in dialysate effluent measure: Evolution of bicarbonate levels in dialysate effluent measure: Evolution of lactate levels in dialysate effluent measure: Evolution of pH of dialysate effluent measure: Total number of device deficiencies and adverse device effects measure: Evolution of delta intraperitoneal pressure during WEAKID treatment measure: Patient tolerance (abdominal discomfort) measure: Evolution of uremic symptoms measure: Usability measure: Baseline characteristics measure: Peritoneal equilibrium tests sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Università degli studi di Modena e Reggio Emilia (UNIMORE) status: NOT_YET_RECRUITING city: Modena zip: 41121 country: Italy name: Gabriele Donati, Prof., MD, PhD role: CONTACT phone: +39-0594225331 email: gabriele.donati@unimore.it name: Giulia Ligabue, MSc, PhD role: CONTACT phone: +39-0594224175 email: giulia.ligabue@unimore.it lat: 44.64783 lon: 10.92539 facility: University Medical Center Utrecht (UMCU) status: RECRUITING city: Utrecht zip: 3584 CX country: Netherlands name: Karin GF Gerritsen, MD, PhD role: CONTACT phone: +31-887557375 email: k.g.f.gerritsen@umcutrecht.nl name: Dian P Bolhuis, MSc role: CONTACT phone: +31-887557375 email: d.p.bolhuis-3@umcutrecht.nl lat: 52.09083 lon: 5.12222 facility: Hospital Universario La Paz (SERMAS) status: NOT_YET_RECRUITING city: Madrid zip: 28029 country: Spain name: Gloria del Peso Gilsanz, MD, PhD role: CONTACT phone: +34-913585339 email: gloria.delpeso@salud.madrid.org name: Maria A Bajo Rubio, MD, PhD role: CONTACT phone: +34-913585339 email: mauxiliadora.bajo@salud.madrid.org lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06314490 id: ASOSCN2A briefTitle: Personalized Antisense Oligonucleotide Therapy for Rare Pediatric Genetic Disease: SCN2A overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-16 date: 2026-02-16 date: 2026-02-16 date: 2024-03-18 date: 2024-03-18 name: University of California, San Diego class: OTHER name: California Institute for Regenerative Medicine (CIRM) name: n-Lorem Foundation briefSummary: This research project entails delivery of a personalized antisense oligonucleotide (ASO) drug designed for a single pediatric participant with SCN2A associated developmental epileptic encephalopathy conditions: Genetic Disease studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1 type: ACTUAL name: nL-SCN2A-002 measure: Seizure frequency measure: Motor function as measured by Dyskinetic Cerebral Palsy Functional Impact Scale measure: Motor function as measured by the motor skills domain of Vineland Adaptive Behavior Scales measure: Motor function as measured by the motor skills domain of Bayley Scales of Infant and Toddler Development measure: Gastrointestinal assessment as measured by the Bristol Stool Chart measure: Neurodevelopmental Function as measured by Aberrant Behavior Checklist measure: Neurodevelopmental Function as measured by Observer-Reported Communication Ability Measure measure: Neurodevelopmental Function as measured by the Vineland Adaptive Behavior Scales measure: Neurodevelopmental Function as measured by the Bayley Scales of Infant and Toddler Development sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Rady Children's Hospital city: San Diego state: California zip: 92123 country: United States lat: 32.71533 lon: -117.15726 hasResults: False

 nctId: NCT06314477 id: HCB/2022/1204 briefTitle: Effect of CPAP Treatment in Patients With Severe Uncontrolled Asthma: The ASTHMA-SLEEP Trial overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-12 date: 2026-12 date: 2024-03-18 date: 2024-03-18 name: Hospital Clinic of Barcelona class: OTHER briefSummary: The aim of the study is to evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and obstructive sleep apnea (OSA) conditions: Obstructive Sleep Apnea conditions: Asthma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 138 type: ESTIMATED name: CPAP treatment name: Hygienic and dietary advice measure: Asthma control questionnaire measure: Asthma control test measure: Lung function- forced expiratory volume in the first second (FEV1) in spirometry measure: Lung function-forced vital capacity (FVC) in spriometry measure: Prevalence of OSA in severe uncontrolled asthma measure: Inflammatory profile measure: Quality of life (Abbreviated Asthma Quality of life Questionnaire- mini-AQLQ questionnaire) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06314464 id: C2023.055 briefTitle: Portable Mixed Reality-based Platform for Assessment of Progress in Multisensory Rehabilitation Strategies Post-TBI acronym: Praxis overallStatus: ENROLLING_BY_INVITATION date: 2024-02-12 date: 2025-04-30 date: 2025-09-30 date: 2024-03-18 date: 2024-03-18 name: BlueHalo class: INDUSTRY name: Brooke Army Medical Center name: University of Pittsburgh briefSummary: The goal of this comparative pilot study is to provide evidence that Praxis, a portable testbed with low-cost wearable sensors and a mixed reality environment, can deliver effective multisensory rehabilitation exercises with military face-validity in a military service member (SM) population after mild Traumatic Brain Injury (mTBI).

The main questions this comparative pilot study aims to answer are:

* Can the Praxis testbed provide feasible/acceptable 4-week multisensory rehabilitation for SMs with post-acute mTBI?
* Can Praxis detect and influence measurable changes in readiness performance during mTBI recovery?

Fifteen SMs with post-acute mTBI from the Center for the Intrepid's Special Operations Performance and Recovery (SPaR) Program will participate in the multisensory vestibular rehabilitation regimen. These SMs will go through 4 weeks of multisensory vestibular rehabilitation including:

* gaze stabilization
* dual-task balance training
* spatial navigation
* agility training

Data from another fifteen SMs, who will not go through the multisensory rehabilitation regimen and will receive supervised cardiovascular exercise, will be used as the control group.

Researchers will compare the Praxis and Control group to determine if the Praxis group shows improvement over the control group with respect to the military-relevant behavioral performance outcomes and patient-reported symptom scores after the end of the rehabilitation. conditions: Brain Concussion conditions: Vestibular Disorder conditions: Cognition Disorder conditions: Mild Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 30 type: ESTIMATED name: Praxis name: Supervised cardiovascular exercise measure: Perceived usability of the Praxis system measured by the System Usability Scale (SUS) measure: Change in Dizziness Handicap Inventory (DHI) score measure: Change in Pittsburgh Sleep Quality Index (PSQI) score measure: Change in Generalized Anxiety Disorder scale (GAD-7) score measure: Change in Post-Traumatic Stress Disorder Check List - Military Version (PCL-M) score measure: Change in Vestibular Activities Avoidance Instrument-9 (VAAI-9) score measure: Change in Headache Impact Test-6 (HIT-6) score measure: Change in Santa Barbara Sense of Direction Scale (SBSOD) score measure: Change in time required to perform 300-yard shuttle run (single- and dual-task) measure: Change in perceived fogginess measure: Change in time required to perform 5-10-5 shuttle run measure: Change in score for 4-Item Hybrid Assessment of Mobility for mTBI (HAM-4-mTBI) measure: Change in time required to perform POrtable WARrior Test Of Tactical AgiLity (POWAR-TOTAL) (single- and dual-task) measure: Change in Vestibular/Ocular Motor Screening (VOMS) total symptom score measure: Compliance with 20-minute daily dose of gaze stability exercises sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Brooke Army Medical Center city: Fort Sam Houston state: Texas zip: 78234 country: United States lat: 29.45746 lon: -98.4472 hasResults: False

 nctId: NCT06314451 id: HAS.22.11.035 briefTitle: Cross-condition Validation of the Steroid PRO overallStatus: RECRUITING date: 2022-06-01 date: 2024-05-31 date: 2024-05-31 date: 2024-03-18 date: 2024-03-20 name: University of the West of England class: OTHER name: Johns Hopkins University name: University of Pittsburgh briefSummary: Testing a questionnaire about treatment with steroids for skin, lung or gastric conditions conditions: Inflammatory Disease conditions: Immune System Disorder conditions: Gastrointestinal Diseases conditions: Dermatologic Disease conditions: Respiratory Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED name: Cognitive Interview measure: Steroid PRO sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of the West of England status: RECRUITING city: Bristol zip: BS2 8HW country: United Kingdom name: Joanna C Robson role: CONTACT phone: 01173427417 email: Jo.Robson@uwe.ac.uk lat: 51.45523 lon: -2.59665 hasResults: False

 nctId: NCT06314438 id: STUDY00017189 id: UL1TR002319 type: NIH link: https://reporter.nih.gov/quickSearch/UL1TR002319 briefTitle: Culturally-Responsive Curriculum for Caregivers With Children at Autism Likelihood overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-15 date: 2024-03-15 date: 2024-03-15 date: 2024-03-18 date: 2024-03-18 name: University of Washington class: OTHER name: National Center for Advancing Translational Sciences (NCATS) briefSummary: The goal of this clinical trial is to examine how helpful and relevant the Family Care Project workbook is for families from culturally and linguistically diverse backgrounds who have a young child at autism likelihood. The main questions this trial aims to answer are:

* Is the Family Care Project workbook useful for families?
* Is the Family Care Project workbook easy to use?
* Can the Family Care Project be implemented by non-profit workers who do not have health backgrounds?

Participants will complete surveys that elicit their feedback on their use of the workbook. conditions: Autism conditions: Development Delay studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 41 type: ACTUAL name: Family Care Project measure: Staff Training Feedback Survey of Implementation Properties (self-report) measure: Staff Competence in Assisting Families with Children at-autism Likelihood Survey (self-report) measure: The Maternal Self-Efficacy Scale Questionnaire measure: Caregiver Knowledge and Use of Behaviors that Support Children at autism-likelihood Survey measure: Current Services Utilized by Families to Support Children at autism-likelihood Survey measure: Family Care Project Feedback Survey of Implementation Properties sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mother Africa city: Kent state: Washington zip: 98032 country: United States lat: 47.38093 lon: -122.23484 hasResults: False

 nctId: NCT06314425 id: IRB_20240714 briefTitle: Zirconia Implants: Practice-based Evidence acronym: SDS overallStatus: RECRUITING date: 2024-04-28 date: 2024-05 date: 2025-12 date: 2024-03-18 date: 2024-04-16 name: Swiss Dental Solutions class: INDUSTRY name: VISTA Institute for Therapeutic Innovations briefSummary: This study is a prospective case series clinical study to examine the effectiveness of Ceramic dental implants manufactured by Swiss Dental Solutions (SDS). Participants with an indication from the dentist for teeth extraction and replacement are invited to participate in this study. Participating in this study will involve the use of dental implants manufactured by Swiss Dental Solutions (SDS zirconia dental implants), submission of the case data, including pre-operative information, intra-operative details, and post-operative follow-up data, to the study site and its collaborating partners.

The SDS zirconia dental implants used in this research are FDA cleared devices that are available for dental treatments. conditions: Dental Implants conditions: Ceramic Implant studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Immediate dental implants placements on fresh sockets after tooth extraction measure: Cumulative Survival Rate (CSR) measure: Marginal Bone Loss (MBL) measure: Pink Esthetic Score (PES) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brighton Periodontal & Implant Dental Group status: RECRUITING city: Woodland Hills state: California zip: 91367 country: United States name: Homayoun Zadeh, PhD, DDS role: CONTACT phone: 818-703-7733 email: homazadeh@gmail.com name: Etyene Schnurr, PhD, DDM role: CONTACT phone: 0797213110 email: etyene.schnurr@swiss-biohealth.com lat: 34.16834 lon: -118.60592 hasResults: False

 nctId: NCT06314412 id: 24C211 briefTitle: Transcutaneous Posterior Tibial Nerve Stimulation in Patients With Multiple Sclerosis Related Urge Incontinence acronym: SANS-REHAB overallStatus: RECRUITING date: 2023-02-13 date: 2025-04 date: 2025-07 date: 2024-03-18 date: 2024-03-18 name: Istituto Auxologico Italiano class: OTHER briefSummary: Recently, several studies have investigated the safety and efficacy of the Stoller afferent nerve stimulation (SANS) treatment in Multiple Sclerosis (MS) patients. However, because of the differences among the published protocols (percutaneous versus transcutaneous stimulation, stimulation site, total number of sessions), and the absence of data on the duration of the effect, this treatment is not yet currently included in the rehabilitation programs. The present study aims at evaluating the efficacy of a protocol of SANS in the short- and medium-term follow-up.

The efficacy of the proposed stimulation protocol on the physiological parameters of bladder function will be also investigated. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Stoller's Afferent Nerve Stimulation (SANS) measure: Measure of variation of incontinence. measure: Measure of variation of urinary urgency sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano status: RECRUITING city: Milan zip: 20122 country: Italy name: Laura Perucca, MD role: CONTACT phone: +3902619116247 email: l.perucca@auxologico.it name: Nicole Bompani, MD role: CONTACT phone: +3902619116151 email: n.bompani@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06314399 id: 2023-18 id: DVO005 2555-CV1837 type: OTHER domain: Universidad del Rosario Research Ethics Committee briefTitle: Predictive Factors Associated to Bile Cultures and Antibiogram Resistance in Patients With Laparoscopic Cholecystectomy acronym: BACILO overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12 date: 2026-06 date: 2024-03-18 date: 2024-03-18 name: Hospital Universitario Mayor Méderi class: OTHER name: Universidad del Rosario briefSummary: The BACILO study was designed with the objective of having robust data on local epidemiological bacterial colonisation information on bile cultures with patients taken to laparoscopic cholecystectomy in our institution to find which predictive factors are associated with culture positivity and antibiotic resistance patterns. Secondary endpoints include evaluating demographical, clinical and surgical variables and establishing comparison between both positive and negative bile cultures and between antibiotic sensitive and resistant microorganism strain isolations. conditions: Biliary Infection conditions: Antibiotic Resistant Strain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 703 type: ESTIMATED name: Bile culture and phenotypic antibiogram resistance test measure: Bile culture positivity measure: Phenotypical antibiogram resistance measure: Microbial characteristics measure: Bile culture and antibiotic resistance relationship measure: Demographical and clinical characteristics measure: Surgical characteristics and outcomes measure: Determination of predictive factors (age, diabetes mellitus, choledocholithiasis / ERCP, C-reactive protein, cholecystitis and Tokyo guidelines severity of cholecystitis) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06314386 id: 23.139.01 id: R01NR020866 type: NIH link: https://reporter.nih.gov/quickSearch/R01NR020866 briefTitle: Systems Analysis and Improvement Approach to Prevent TB acronym: SAIA-TB overallStatus: NOT_YET_RECRUITING date: 2025-01-06 date: 2028-02-29 date: 2029-02-28 date: 2024-03-18 date: 2024-03-18 name: Boston College class: OTHER name: National Institutes of Health (NIH) name: Boston University name: University of Washington name: Medical Research Council, South Africa name: National Institute of Nursing Research (NINR) briefSummary: This randomized trial uses the evidence-based Systems Analysis and Improvement Approach (SAIA) adapted for tuberculosis (SAIA-TB) to assess the comprehensive tuberculosis (TB) care cascade across 16 clinics in rural Eastern Cape, South Africa to improve patient outcomes. The aims of this study are to:

* Evaluate the effectiveness of SAIA-TB use in clinics on TB cascade outcomes for TB patients and with high-risk contacts
* Determine the drivers of SAIA-TB implementation success or failure across clinics

The investigators hypothesize that SAIA-TB implementation will lead to a 20% increase in each of: TB screening, TB preventive treatment initiation, and TB disease treatment initiation during the 18-month intervention period. conditions: Tuberculosis conditions: TPT conditions: TB - Tuberculosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Stepped Wedge Crossover Cluster primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 19560 type: ESTIMATED name: Systems Analysis and Improvement Approach for TB (SAIA-TB) measure: TB Screening measure: Linkage to care for TB disease treatment measure: TB Evaluation measure: TB Diagnosis measure: Successful TB Prevention Treatment (TPT) Outcome measure: Successful TB Outcome sex: ALL minimumAge: 0 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Addo Clinic city: Addo country: South Africa lat: -33.54833 lon: 25.6899 facility: Lukhanyiso Clinic city: Addo country: South Africa lat: -33.54833 lon: 25.6899 facility: Kwa-Nonqubela Clinic city: Alexandria country: South Africa facility: Marselle Clinic city: Boesmansriviermond country: South Africa lat: -33.6863 lon: 26.65604 facility: Masakhane Clinic city: Hankey country: South Africa lat: -33.83308 lon: 24.88359 facility: Humansdorp Clinic city: Humansdorp country: South Africa lat: -34.02903 lon: 24.76912 facility: Pellsrus Clinic city: Jeffrey's Bay country: South Africa lat: -34.05031 lon: 24.90762 facility: Joubertina CHC city: Joubertina country: South Africa lat: -33.82547 lon: 23.85618 facility: Louterwater Clinic city: Joubertina country: South Africa lat: -33.82547 lon: 23.85618 facility: Twee Riviere Clinic city: Joubertina country: South Africa lat: -33.82547 lon: 23.85618 facility: Kareedouw Clinic city: Kareedouw country: South Africa lat: -33.9528 lon: 24.29053 facility: Kenton On Sea Clinic city: Kenton on Sea country: South Africa lat: -33.68421 lon: 26.67036 facility: Kirkwood Clinic city: Kirkwood country: South Africa lat: -33.39829 lon: 25.44279 facility: Moses Mabida Clinic city: Kirkwood country: South Africa lat: -33.39829 lon: 25.44279 facility: Imizamo Yetho Clinic city: Patensie country: South Africa lat: -33.76007 lon: 24.81383 facility: Nkwenkwezi Clinic city: Port Alfred country: South Africa lat: -33.58601 lon: 26.88329 hasResults: False

 nctId: NCT06314373 id: HSK39775-101/201 briefTitle: A Study for HSK39775 in Participants With Solid Tumors overallStatus: RECRUITING date: 2024-03-07 date: 2028-02-01 date: 2028-09-01 date: 2024-03-18 date: 2024-03-18 name: Xizang Haisco Pharmaceutical Co., Ltd class: INDUSTRY briefSummary: This research is designed to determine if HSK39775 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors. conditions: Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 243 type: ESTIMATED name: HSK39775 Monotherapy measure: AE/SAE measure: DLT measure: MTD/MAD measure: Maximum Plasma Concentration [Cmax] measure: Area Under Curve[AUC] measure: Time to maximum observed concentration [Tmax] measure: Elimination half-life [t1/2] measure: Overall Response Rate (ORR) per RECIST V1.1 measure: Progression Free Survival measure: Time To Response measure: Disease Control Rate measure: Best percentage change in target lesion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fundan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06314360 id: BAP_PFS briefTitle: Comparison of Foot Posture, Plantar Pressure, and Postural Balance in Patellofemoral Pain Patients and Healthy Subjects overallStatus: ENROLLING_BY_INVITATION date: 2024-03 date: 2024-06 date: 2024-10 date: 2024-03-18 date: 2024-03-18 name: Hacettepe University class: OTHER briefSummary: Patellofemoral pain syndrome (PFS) is a musculoskeletal problem characterized by pain felt in the front of the knee or behind the patella, commonly affecting individuals in adolescence or young adulthood, especially those engaged in sports such as cycling and running. It is one of the most encountered knee injuries and can have a poor prognosis. The intensity of knee pain increases during functional activities such as stair climbing, squatting, running, and jumping due to the increased patellofemoral joint reaction force.

A disturbance in postural stability is observed in individuals with PFS due to pain during functional activities. Studies examining changes in foot posture, plantar pressure, and postural balance in individuals with PFS are quite limited and controversial. Moreover, research that simultaneously investigates these parameters and interprets the results is scarce. Some studies have utilized detailed technical systems such as medical imaging or motion analysis, while practical methods incorporating foot posture and plantar pressure analyses are available and easy to use in clinical settings.

There is a lack of literature on the easy assessment and interpretation of plantar pressure, postural balance, and functional activities in individuals with PFS. Within the scope of this project, the plan is to assess plantar pressure, postural balance, and functional activities in individuals with PFS. The aim is to quickly interpret the biomechanical changes occurring in these individuals and guide rehabilitation programs based on the obtained data.

The use of practical and fast assessment methods in planning treatments for PFS is crucial for early rehabilitation planning. Practical methods such as foot posture, plantar pressure, and postural balance assessments, which can be used in clinical settings, may provide benefits in shaping rehabilitation goals related to lower extremity alignment in individuals with PFS. The objective of this study is to compare the foot posture, plantar pressure, and postural stability of individuals with PFS with healthy individuals. Additionally, the investigators aim to investigate the relationship between foot posture, plantar pressure parameters, postural balance, and functional level in individuals with PFS. Through these objectives, it will be possible to identify potential parameters that could be effective in rehabilitation processes and contribute to determining treatment programs by revealing biomechanical changes in individuals with PFS. conditions: Patellofemoral Pain Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: No intervention. measure: Plantar Pressure measure: Postural Stability measure: Foot posture measure: Functionality measure: Pain Assessment measure: Limb dominance sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Hacettepe University city: Ankara state: Ankara/Sıhhıye zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06314347 id: gibtuipekkirmaci briefTitle: Reference Value of Figure of 8 Walk Test overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-30 date: 2024-11-30 date: 2024-03-18 date: 2024-03-18 name: Gaziantep Islam Science and Technology University class: OTHER briefSummary: The aim of the study is to determine the reference values of the Figure 8 Walking Test in healthy adults. conditions: Healthy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 1000 type: ESTIMATED name: Figure of 8 walk test measure: Figure of 8 walk test measure: Age measure: gender measure: height measure: weight sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06314334 id: SHCA-NKT-202301 briefTitle: Screening Study of Combined Sequential Chemotherapy and Radiation Therapy for Early-stage NK/T-cell Lymphoma overallStatus: RECRUITING date: 2023-03-04 date: 2026-12-30 date: 2028-12-30 date: 2024-03-18 date: 2024-03-18 name: Fudan University class: OTHER briefSummary: Extranodal NK/T-cell lymphoma, nasal type (NKTCL) is a common malignant tumor in East Asian populations, often starting in the nasal cavity and spreading to other organs. Associated with EBV infection, NKTCL is aggressive. Early-stage patients typically receive chemo and radiotherapy, with promising outcomes. Recent studies show the potential of immune checkpoint inhibitors in NKTCL treatment. However, optimal treatment sequencing and efficacy remain unclear. This study aims to compare three strategies: (A) Pegaspargase with Sintilimab and radiotherapy; (B) chemo then radiotherapy (PGemOx); (C) sandwich chemoradiotherapy (GELAD). The goal is to identify the best treatment based on 24-month progression-free survival. conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants were stratified according to the NRI prognostic index obtained from the baseline assessment (NRI \<2, NRI ≥2) and randomly assigned to three groups receiving different experimental treatments.

Group A (synchronous treatment group) received 4 cycles of Sintilimab combined with pegaspargase therapy. Concurrently, they received radiotherapy treatment. Group B (sequential treatment group) received 4 cycles of the PGEMOX regimen chemotherapy with sequential radiotherapy.

Group C (sandwiched radiotherapy group) received 2 cycles of the GELAD regimen chemotherapy initially, followed by radiotherapy and another two cycles GELAD chemotherapy. primaryPurpose: TREATMENT masking: NONE count: 210 type: ESTIMATED name: Sintilimab+Pegaspargase name: P-GemOx name: GELAD name: IMRT measure: PFS24 measure: ORR measure: OS measure: EFS measure: TRAE sex: ALL 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: Rong Tao, MD role: CONTACT phone: 8621-64175590 email: rtao@shca.org.cn name: Chuanxu Liu, MD role: CONTACT phone: 8621-64175590 email: liuchuanxu@shca.org.cn name: Rong Tao, MD role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06314321 id: 2021-K151-01 briefTitle: The Effect of Baduanjin on Shoulder Function in Maintenance Hemodialysis Patients overallStatus: COMPLETED date: 2022-01-01 date: 2023-06-30 date: 2024-02-20 date: 2024-03-18 date: 2024-03-29 name: Affiliated Hospital of Nantong University class: OTHER briefSummary: The aim of this study is to examine the effect of 18-month Baduanjin exercise on shoulder joint function in maintenance hemodialysis (MHD) patients. 60 MHD patients aged 18-75 will included in this study and randomly divided into two groups (intervention group and control group). The intervention group will be led by a professional person and underwent Baduanjin exercise three times a week before hemodialysis. The control group maintained routine treatment and daily activities. conditions: Hemodialysis Complication conditions: Shoulder Joint Disorder conditions: CKD-MBD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: Baduanjin exercise measure: Shoulder joint function score measure: Shoulder joint internal rotation function measure: Muscle strength measurement measure: Area of biceps brachii muscle measure: Changes in the Short Form-36 (SF-36) and European Quality of Life Five Dimension（EQ-5D-5L） measure: Changes in the Hospital Anxiety and Depression Scale （HADS） sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Hospital of Nantong University city: Nantong state: Jiangsu zip: 226000 country: China lat: 32.03028 lon: 120.87472 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2021-11-30 uploadDate: 2024-03-12T09:17 filename: Prot_SAP_000.pdf size: 148387 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2021-11-30 uploadDate: 2024-03-12T09:19 filename: ICF_001.pdf size: 165056 hasResults: False

 nctId: NCT06314308 id: AAAU8161 id: 5P30AG064198-05 type: NIH link: https://reporter.nih.gov/quickSearch/5P30AG064198-05 briefTitle: Community Health Worker Assisted Task Specific and Cognitive Therapy at Home With Exposure After Stroke acronym: CATCHES overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-05 date: 2025-05 date: 2024-03-18 date: 2024-03-26 name: Columbia University class: OTHER name: National Institute on Aging (NIA) briefSummary: CATCHES is a novel intervention for preliminary testing, integrating Task Specific Therapy at home guided by Community Health Workers (CHW) under supervision of a licensed Physical Therapist (PT) guided by telehealth based Cognitive Behavioral Therapy (CBT) to reduce task specific fears through repetitive exposure and adaptive behavioral activation strategies and facilitate engagement in physical activity.

1. To integrate and establish feasibility of CATCHES intervention. Hypothesis: A multidisciplinary team providing home based TST with exposure therapy tailored to an underserved urban setting will inform a patient-centered behavioral intervention to reduce fear of falling (FOF) among post-acute stroke patients returning home. Feasibility outcomes will include recruitment, retention, and fidelity of implementation.
2. Test effects of the intervention on hypothesized treatment mechanism of fear of falling. Hypothesis: Therapy will reduce task specific fear of falling Primary outcome will be change in Activities-specific Balance Confidence Scale.
3. Explore physical activity measures subjectively and objectively. Exploratory outcomes include pre and post Timed Up and Go test, patient reported outcome surveys and activity as measured by wearable devices. conditions: Stroke, Acute Ischemic studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 30 type: ESTIMATED name: CATCHES measure: Percentage of intervention completers to demonstrate feasibility measure: Change in Activities-specific Balance Confidence Scale Score measure: Timed Up and Go Test Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Neurological Institute of New York, Columbia University city: New York state: New York zip: 10032 country: United States name: Carmen Castillo role: CONTACT phone: 212-305-7755 email: cec34@cumc.columbia.edu name: Imama Naqvi, MD role: CONTACT email: ian2108@cumc.columbia.edu name: Imama A. Naqvi, MD role: PRINCIPAL_INVESTIGATOR name: Lori Quinn, PhD role: SUB_INVESTIGATOR name: Olajide A Williams, MD, MS role: SUB_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06314295 id: BeijingH-WF briefTitle: Automated Echocardiographic Detection of Coronary Artery Disease Using Artificial Intelligence Methods overallStatus: NOT_YET_RECRUITING date: 2024-03-11 date: 2026-03-11 date: 2026-04-11 date: 2024-03-18 date: 2024-03-18 name: Beijing Hospital class: OTHER_GOV briefSummary: The incidence rate and mortality of coronary artery disease are increasing year by year. Exploring non-invasive, accurate, and widely applicable methods to screen and diagnosis is of great significance. New ultrasound techniques, such as non-invasive myocardial work, have been proven to be superior to traditional ultrasound techniques in screening and diagnosis. However, diagnostic analysis based on ultrasound video images is time-consuming and subjective. The progress of artificial intelligence technology in fully automated quantitative evaluation of video images provides the possibility for computer-aided design screening and diagnosis. At present, the application of artificial intelligence in computer-aided design is a cutting-edge issue in the field of cardiovascular disease research. The application of artificial intelligence technology in the construction of computer-aided diagnostic models based on ultrasound video images is still in its early stages. conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 1500 type: ESTIMATED measure: Different coronary angiography results sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06314282 id: D3461R00072 briefTitle: INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use acronym: INTERSTELLAR overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2027-08-31 date: 2027-08-31 date: 2024-03-18 date: 2024-03-18 name: AstraZeneca class: INDUSTRY briefSummary: INTERSTELLAR study will generate critical prospective real-world evidence on the benefits of adding Anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients. The study will use clinical assessments that are relevant for SLE-treating physicians in routine clinical practice, as well as introduce a specific measure for skin manifestations to affirm the potency of anifrolumab in treating SLE-related skin manifestations. The study will use standardized objectives, inclusion/exclusion criteria and outcome measures across all countries participating in this study including GCC (Qatar, KSA), Mexico, CAMCAR (Costa Rica, Panama, Dominican Republic), Colombia, Argentina, Taiwan, and Egypt, and any other countries that may be included in the study, in order to facilitate a comparison and analysis across all countries included in this study. conditions: Systemic Lupus Erythematosus (SLE) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: PGA measure: SLEDAI-2K measure: CLASI measure: FACIT-Fatigue measure: LupusQoL measure: EQ-5D-5L sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06314269 id: 246810121416 briefTitle: Incidence of Perioperative Cerebrovascular Stroke in Assuit University Hospitals , Hospital Based Study overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-31 date: 2025-09-30 date: 2024-03-18 date: 2024-03-20 name: Assiut University class: OTHER briefSummary: Stroke is the most common cause of disability in elderly people (over 65years of age) and the third most common cause of death in the world . The World Health Organization estimates that one in six people globally will suffer from stroke in their lifetime.

Perioperative stroke is the most unwanted complication for patients, as well as for surgeons and anesthesiologists . The reported risk of perioperative stroke varies with the type of surgery. Its incidence is generally not high (approximate 0.1-1.9%) in non-cardiac, non-neurologic, and non-major surgery However, it may occur in up to 10% of patients undergoing high-risk cardiac or brain surgery . Patients with perioperative stroke are less likely to have a good functional outcome and have an eight-fold higher mortality compared with those without perioperative stroke conditions: Perioperative Complication studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 1 type: ESTIMATED measure: 1- To determine incidence and prevalence of perioperative cerebrvosacular stroke in General surgery, cardiothorasic surgery and vascular surgery departments , Assuit university hospitalis , Egypt. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06314256 id: 2023/218 briefTitle: Clinical Evaluation of Hyaluronic Acid and Platelet Rich Fibrin Injection Efficacy in Interdental Papilla Reconstruction overallStatus: RECRUITING date: 2024-04-10 date: 2024-10-10 date: 2024-11-10 date: 2024-03-18 date: 2024-03-18 name: Altinbas University class: OTHER briefSummary: The goal of this clinical trial is to evaluate and compare the efficacy of injectable platelet rich fibrin (i-PRF) and hyaluronic acid (HA) in reconstruction of interdental papilla loss. The main questions it aims to answer are:

* How compareable are above mentioned two interventions (i-PRF\&HA) in reconstruction of interdental papilla loss?
* Which treatment option is better accepted by patients? Which treatment option would patients be more satisfied with? Participants with multiple interdental papilla loss will be treated with both i-PRF and HA in split-mouth design. Researchers will compare two treatment options to see if black triangles caused by interdental papilla loss closes and if yes, for how long do they last. conditions: Interdental Papilla Loss studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A type of study used frequently in oral research: the mouth is divided into two or more subunits. Active and control (comparison) treatments are applied to the subunits (e.g., to the left and right sides). primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participant will be masked which side of her/his mouth treated with either i-PRF or HA. whoMasked: PARTICIPANT count: 15 type: ESTIMATED name: Injection name: Injection measure: Reduction in Black Triangle Area measure: Reduction in Black Triangle Height measure: Reduction in Black Triangle Width measure: Volume Gain of Interdental Papilla measure: Patient Satisfaction Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Altinbas University status: RECRUITING city: Istanbul country: Turkey name: Baris Impram role: CONTACT phone: +905343148500 email: barisimpram@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06314243 id: RHDIRB2020110301 REC #241 briefTitle: The Impact of Pumpkin Seed Oil Supplementation on Hemodialysis Patients overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-08 date: 2025-05 date: 2024-03-18 date: 2024-03-18 name: Ain Shams University class: OTHER briefSummary: The goal of this clinical trial is to investigate the effects of Pumpkin Seed Oil (PSO) supplementation on systemic inflammation, oxidative stress, and lipid profile in hemodialysis patients.

The main question it aims to answer is:

• Does PSO have a promising effect on systemic inflammation, oxidative stress, and lipid profile in hemodialysis patients?

Patients on regular hemodialysis who take PSO supplementation will be compared to those who don't to see if PSO supplementation improves their systemic inflammation, oxidative stress, and lipid profile. conditions: Hemodialysis Patients studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Design: Prospective, randomized, Open label - controlled clinical trial.

Patients: A total of 56 patients on regular hemodialysis (HD) will be enrolled in the study. These patients will be randomly allocated into two equal groups:

* Group 1 (PSO group): consists of 28 patients who will receive one capsule containing 1010 mg PSO once daily for 12 weeks, " Ronkin®, KMT PHARMA, Egypt. "
* Group 2 (Control group): consists of 28 patients who will not receive the intervention. primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: Pumpkin Seed Oil " Ronkin®, KMT PHARMA, Egypt. " measure: To evaluate the effect of PSO supplementation on oxidative stress in hemodialysis patients. measure: To evaluate the effect of PSO supplementation on the systemic inflammation in hemodialysis patients. measure: To evaluate the effect of PSO supplementation on the lipid profile in hemodialysis patients. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06314230 id: AUSCAD briefTitle: Australian Genomics Of Chronic Allograft Dysfunction Study acronym: AUSCAD overallStatus: RECRUITING date: 2012-04-26 date: 2040-01-01 date: 2040-01-01 date: 2024-03-15 date: 2024-04-10 name: Western Sydney Local Health District class: OTHER briefSummary: The goal of the Australian Genomics of Chronic Allograft Dysfunction (AUSCAD) study is a single centre (Westmead Hospital), prospective, observational study, which enrols patients at time of kidney (or kidney-transplant) transplant and tracks the post transplant course. The AUSCAD study aims to generate new knowledge and improve outcomes following kidney transplantation. The primary aim is to determine whether important outcomes (including chronic rejection and graft loss) are correlated with patterns of allograft reactivity, gene expression and susceptibility profiles. conditions: Kidney Transplant Rejection conditions: Kidney Transplant; Complications studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Graft failure measure: Allograft rejection measure: Gene profile measure: Death measure: Major infectious adverse outcomes measure: Major malignancy related adverse outcomes measure: Major cardiovascular adverse outcomes measure: Chronic allograft dysfunction measure: BK virus associated nephropathy measure: Albuminuria measure: Surrogate end-points measure: Delayed graft function (DGF) measure: Death censored graft loss (DCGL) measure: Treatment resistant rejection sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Westmead Hospital status: RECRUITING city: Westmead state: New South Wales zip: 2145 country: Australia name: Jennifer SY Li, MBBS, FRACP role: CONTACT email: jennifer.li@health.nsw.gov.au lat: -33.80383 lon: 150.98768 facility: Westmead Institute for Medical Research status: RECRUITING city: Westmead state: New South Wales zip: 2145 country: Australia name: Philip J O'Connell, MBBS, FRACP role: CONTACT email: philip.oconnell@sydney.edu.au lat: -33.80383 lon: 150.98768 hasResults: False

 nctId: NCT06314217 id: CL-00002 id: 202330714 type: REGISTRY domain: MOH ISRAEL briefTitle: Everads Injector in Suprachoroidal Administration of TA Suspension, for Treatment of Patients With DME overallStatus: RECRUITING date: 2024-02-18 date: 2024-12-30 date: 2025-03-30 date: 2024-03-15 date: 2024-03-15 name: Everads Therapy class: INDUSTRY briefSummary: This is an open-label pilot device study. The aim of the study is to evaluate the safety and performance of Everads Injector following single injection of suspension approved for ocular use into the suprachoroidal space.

The study population is patients diagnosed with diabetic macular edema (DME) that were previously treated. 10 adult subjects are expected to be enrolled based on the inclusion-exclusion criteria.

The study will involve 6 visits during a period of 6 weeks conditions: Diabetic Macular Edema studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Everads Injector: For targeted suprachoroidal delivery of therapy primaryPurpose: OTHER masking: NONE count: 10 type: ESTIMATED name: Everads Injector measure: Frequency of treatment-emergent adverse events measure: Frequency of adverse device effects measure: Confirmation of TA delivery into the suprachoroidal space measure: Change from baseline in central macular thickness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rambam MC status: RECRUITING city: Haifa country: Israel name: Meital Abecassis role: CONTACT phone: 047772668 name: Yoreh Barak, MD role: PRINCIPAL_INVESTIGATOR lat: 32.81841 lon: 34.9885 hasResults: False

 nctId: NCT06314204 id: 2015-A01222-47 briefTitle: Impact of Cannabis Consumption on the Course, Modalities of Hospitalization and the Short-term Prognosis of Inpatients Suffering From Psychotic Symptoms acronym: canhope overallStatus: RECRUITING date: 2016-09-20 date: 2025-09-06 date: 2026-09-06 date: 2024-03-15 date: 2024-03-15 name: Centre hospitalier de Ville-Evrard, France class: OTHER briefSummary: Few studies have evaluated, in patients with symptomatology the impact of cannabis use on the duration of hospitalization and on short- and medium-term developments. The objective of this study will be to assess the impact of cannabis on the duration, the hospitalization and the short- and medium-term evolution of patients with psychotic symptoms and cannabis use. We hypothesize that these patients (in comparison with patients with psychotic symptomatology and not using cannabis) would be hospitalized more long, exposed to a higher risk of resistance to the usual therapeutics, would have a lack of therapeutic alliance and insight, relapses and hospitalizations more frequent, more marked negative symptoms and lower quality remission. They would also be more prone to impulsive and aggressive behaviour. conditions: Psychotic; Disorder, Cannabis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: PANSS: Positive and Negative Syndrom Scale measure: PANSS: Positive and Negative Syndrom Scale measure: PANSS: Positive and Negative Syndrom Scale measure: PANSS: Positive and Negative Syndrom Scale measure: MCQ-SF :Marijuana Craving Questionnaire- Short Form measure: MCQ-SF :Marijuana Craving Questionnaire- Short Form) measure: MCQ-SF :Marijuana Craving Questionnaire- Short Form) measure: MCQ-SF :Marijuana Craving Questionnaire- Short Form) measure: CGI: Clinical Global Impression measure: CGI: Clinical Global Impression measure: CGI: Clinical Global Impression measure: CGI: Clinical Global Impression measure: MADRS: Montgomery Åsberg Depression Rating Scale measure: MADRS: Montgomery Åsberg Depression Rating Scale measure: MADRS: Montgomery Åsberg Depression Rating Scale measure: MADRS: Montgomery Åsberg Depression Rating Scale measure: PDS: Psychotic Depression Scale measure: PDS: Psychotic Depression Scale measure: PDS: Psychotic Depression Scale measure: PDS: Psychotic Depression Scale measure: YMRS: Young Mania Rating Scale measure: YMRS: Young Mania Rating Scale measure: YMRS: Young Mania Rating Scale measure: YMRS: Young Mania Rating Scale measure: CDS: Self-Consciousness Revised Scale measure: CTQ: Childhood Trauma Questionnaire measure: BFI: Big Five Inventory sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: unité de recherche clinique de l'E.P.S de Ville Evrard status: RECRUITING city: Neuilly Sur Marne zip: 93332 country: France name: Rusheenthira THAVASEELAN, Msc role: CONTACT phone: 0143093232 email: r.thavaseelan@epsve.fr lat: 48.85373 lon: 2.54903 hasResults: False

 nctId: NCT06314191 id: 23-AOIP-02 briefTitle: Adipose Tissue and Symptomatic Gonarthrosis acronym: TAGS overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-04-15 date: 2025-09-15 date: 2024-03-15 date: 2024-03-15 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: 1. Prevalence of osteoarthritis in France Osteoarthritis (OA) is a very common disease, affecting almost 15% of the population. It is responsible for a significant socio-economic cost in connection with the chronic and disabling pain it causes . Gonarthrosis is the most frequently encountered arthritic localization . In a large 2010 meta-analysis, the main risk factors for developing knee OA were shown to be obesity, previous knee trauma, hand OA, female gender and advanced age. Smoking appeared to have a moderate protective effect . The risk of developing gonarthrosis in obese patients is 2.6 times higher than in the general population. Hypercholesterolemia itself is a risk factor for osteoarthritis, as are increased plasma levels of specific fatty acids and lipoproteins Inflammatory mechanism in osteoarthritis. Studies have shown that plasma levels of C-reactive protein, can be used to estimate individual susceptibility to developing osteoarthritis over a lifetime . In osteoarthritis patients, plasma concentrations of TNF-α, IL-6 and IL-1 are abnormally high, which appears to contribute to cartilage loss in these subjects .

3. Inflammatory mechanism in obesity. Obesity induces systemic and local joint mechanical stresses that increase the risk of developing gonarthrosis in obese or overweight individuals . Beyond the simple mechanical aspect, a body of evidence supports the assertion that obesity is responsible for a systemic inflammatory state, deleterious to joints. 1) Obesity is associated with radiographic and symptomatic osteoarthritis in non-weight-bearing joints, such as the hand In overweight and obese adults, plasma levels of tumor necrosis factor alpha (TNF-α) and interleukin-6 (IL-6) are significantly increased .

3)Weight loss in obese subjects with osteoarthritis alleviates joint symptoms through reduced mechanical stress but also through reduced production and response of inflammatory products .

4. Common inflammatory mechanisms between adipose tissue and obesity. The relationship between adipose tissue and inflammation is complex given the different types of adipose tissue and the action of cells derived from it. Adipose tissue is an active endocrine organ composed of mature and developing adipocytes, as well as fibroblasts, endothelial cells and a wide range of immune cells, namely adipose tissue macrophages, neutrophils, eosinophils, mast cells, T cells and B cells. Adipose tissue is recognized as an endocrine organ that secretes a large number of inflammatory mediators, including cytokines (IL-1, IL-6, IL-8, TNF-α) and adipokines (leptin, adiponectin, resistin, visfatin). Communication between adipocytes and immune cells maintains tissue homeostasis. Obesity, however, can upset this balance.

Lipid metabolism and joint disorders have been shown to be linked . A high-fat diet may contribute to the development of osteoarthritis .

White and brown adipose tissue appear to play a complementary role in the development of osteoarthritis. Increased white adipose tissue in obesity is thought to create a systemic environment of increased inflammation through the release of pro-inflammatory cytokines and adipokines such as leptin and visfatin, all of which have been associated with osteoarthritis . Locally, white adipocytes in infra patellar adipose tissue are architecturally different in patients without gonarthrosis compared with those with knee osteoarthritis. This difference suggests that adipocyte gene expression is directly influenced by inflammation . In obese individuals, there is elevated IL-6 production in brown adipose tissue . Furthermore, it would appear that brown adipose tissue, unlike white, down-regulates the inflammatory profile of macrophages . conditions: Gonarthrosis conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ESTIMATED name: blood sampling name: knee radiography measure: lipolytic activity measure: lipolysis measurement sex: ALL minimumAge: 30 Years maximumAge: 55 Years stdAges: ADULT facility: Nice University Hospital city: Nice zip: 06000 country: France name: Christian Roux role: CONTACT phone: 0492039220 email: roux.c2@chu-nice.fr name: Isa Costantini role: CONTACT phone: 0492039220 email: constantini.i@chu-nice.fr name: Christian Roux role: PRINCIPAL_INVESTIGATOR name: Antonio Iannelli role: SUB_INVESTIGATOR lat: 43.70313 lon: 7.26608 hasResults: False

 nctId: NCT06314178 id: p-2024-15469 briefTitle: Assessing Demographic Biases in Deep Learning Model for Fetal Growth Estimation in Clinical Practice. Patients Eligible for Inclusion Are Women With a Gestational Age Between 24-42 Weeks Undergoing a Third-trimester Growth Scan. The Image Data From the Scan Are Used to Calculate Fetal Weight. overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-07-30 date: 2024-07-30 date: 2024-03-15 date: 2024-03-15 name: Copenhagen Academy for Medical Education and Simulation class: OTHER briefSummary: The goal of this observational study is to compare a new artificial intelligence (AI) feedback tool with the traditional method for estimating fetal weight during ultrasound scans on pregnant women between 24-42 weeks of gestation. The study aims to investigate the presence of demographic bias in the AI model. The demographic factors examined in the study include Body Mass Index (BMI), the number of births, fetal age, mother\&#39;s age, fetal sex, and the presence of preeclampsia. Moreover, the study will compare the accuracy of the AI model and the Hadlock model, a fetal growth formula, in estimating fetal weight. Participants will have their ultrasound scans pseudonymized and securely stored on password-protected removable drives, ensuring their identity and privacy are maintained. Afterward, the ultrasound data will be sent to the Technical University of Denmark (DTU), where the AI model will analyze the images to estimate fetal weight. conditions: Pregnancy Complications studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: Demographic biases measure: Comparing the accuracy of the Hadlock formula and the AI model sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06314165 id: PamukkaleU-SBE-RND-01 briefTitle: Evaluation of the Effect of Music Medicine Application on Menstrual Symptoms overallStatus: RECRUITING date: 2024-03-10 date: 2025-02 date: 2025-02 date: 2024-03-15 date: 2024-03-21 name: Pamukkale University class: OTHER briefSummary: In this study, the "Music Medicine Application" method was chosen in line with the literature and guidelines and it is aimed to determine whether it is effective in reducing the symptoms experienced by female students with "Music Medicine Application" during the menstrual period. conditions: Menstruation; Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups: comparative experiment and control primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Participants included in the study will not know which group they are in. In this way, the study will be carried out in a single-blind manner. whoMasked: PARTICIPANT count: 62 type: ESTIMATED name: music medicine practice measure: menstruation symptom scale measure: Visual Analogue Scale sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Pamukkale University Faculty of Health Sciences status: RECRUITING city: Denizli zip: 20180 country: Turkey name: Rabia Nur Doğan role: CONTACT phone: +905528400797 email: rabianur_1997@hotmail.com lat: 37.77417 lon: 29.0875 hasResults: False

 nctId: NCT06314152 id: 2023032 briefTitle: 3-point With 1-point Mesh Fixation in TAPP for Inguinal Hernia overallStatus: RECRUITING date: 2023-01-01 date: 2024-10-10 date: 2024-10-10 date: 2024-03-15 date: 2024-03-20 name: Nanchong Central Hospital class: OTHER_GOV name: Guang'an People's Hospital name: Pengan County People's Hospital name: People's Hospital of Yilong County name: Nanbu Hospital of County Chinese Medicine name: Langzhong People's Hospital name: Langzhong Traditional Chinese Medicine Hospital briefSummary: This study was designed to compare the outcome of 3 point with 1 point lightweight mesh fixation in TAPP surgery for patients with inguinal hernia. The main outcome include seroma, chronic pain, recurrence, et al. conditions: Inguinal Hernia conditions: Chronic Pain conditions: Seroma conditions: Recurrent conditions: Infections conditions: Hematoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 337 type: ESTIMATED name: Lightweight mesh fixation in 3 points or 1 point measure: Rate of recurrence measure: Rate of postoperative pain measure: Rate of postoperative complications sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yunhong Tian status: RECRUITING city: Nanchong state: Sichuan zip: 637000 country: China name: Yunhong Tian, PHD role: CONTACT phone: 13508087719 email: drtianyunhong@126.com lat: 30.79508 lon: 106.08473 hasResults: False

 nctId: NCT06314139 id: YanmingXu001 briefTitle: Tolerability and Efficacy of Continuous Theta-burst Stimulation for Essential Tremor: A Randomized Study. overallStatus: COMPLETED date: 2022-09-01 date: 2023-04-06 date: 2023-06-01 date: 2024-03-15 date: 2024-03-15 name: West China Hospital class: OTHER briefSummary: Essential tremor (ET) is one of the most common movement disorders in adults. The prevalence rate among the elderly over 65 years old is about 4.6%. Tremor usually worsens with age, leading to disability and loss of independence, which has an adverse impact on the quality of life of patients. However, the traditional first-line treatment drugs are neither effective enough nor completely safe for ET patients. Although surgical procedures such as deep brain stimulation (DBS) and thalamotomy can be used to better control unilateral limb tremor, many patients are reluctant to choose surgical treatment because it's invasive. Therefore, there is an urgent need to develop new drugs or non-invasive therapies as a better treatment option for ET.

The pathology of the disease is not yet clear, it is generally believed that genetic, aging and environmental factors are related to ET. Hyperactivity of cerebellar function and changes of cerebello-thalamo- cortical (CTC) pathways are currently considered to be the most important pathophysiological mechanisms of ET. Therefore, the cerebellum and cortex may be the best targets for the treatment of tremor.

Continuous theta burst stimulation (cTBS) is one of the non-invasive electrophysiological techniques characterized by plexus stimulation, which is similar to low-frequency repetitive transcranial magnetic stimulation (rTMS) but closer to the physiological state of neural activity, and may inhibit the excitability of the stimulated cortex. The stimulation duration is greatly shortened, which is simpler and easier than the low-frequency rTMS of 20-30 minutes. In addition, functional near infrared spectroscopy (fNIRS) is a new non-invasive functional neuroimaging technique. It mainly uses the difference characteristics of oxyhemoglobin and deoxyhemoglobin in brain tissue for near-infrared light absorption at different wavelengths of 600-900nm. The efficacy, safety, and mechanisms involved in non-invasive stimulation therapy for ET patients are still unclear. There are few studies on the treatment of ET with cTBS, and the sample size is small (the largest sample includes only 23 ET patients). Additionally, there was a lack of exploration on the therapeutic mechanism of cTBS for ET patients. Therefore, the investigators conducted a double-blind, randomized, sham-controlled clinical trial to evaluate the safety and efficacy of cTBS in the treatment of ET patients over both cerebellar and cortical area. conditions: Essential Tremor conditions: Continuous Theta Burst Stimulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: continuous theta-burst stimulation (cTBS) measure: Tremor assessment using Fahn-Tolosa-Marin (FTM) tremor-rating scales measure: Clinical global impression-improvement (CGI-I) rating scores measure: Electrophysiological evaluation of cortical excitability and inhibition measured by TMS. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Neurology, West China Hospital, Sichuan University, 37 Guo Xue Xiang, Chengdu, Sichuan Province 610041, P.R. China. city: Chengdu state: Sichuan Sheng zip: 610041 country: China lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06314126 id: ENDO-DCI briefTitle: Evaluation of D-Chiro-Inositol Treatment in Women With Endometriosis acronym: ENDO-DCI overallStatus: RECRUITING date: 2024-01-01 date: 2025-01 date: 2025-04 date: 2024-03-15 date: 2024-03-15 name: University of Palermo class: OTHER briefSummary: To date, the treatment for endometriosis is represented by the surgical removal of the lesions. Nonetheless, in the years following surgery, the lesions can recur, often due to excessive estrogen production. To balance estrogen, progestin- or estrogen-progestin-based medications are generally prescribed. On the other hand, progestins and estrogen-progestins act as contraceptives, preventing the onset of a pregnancy. At the same time, these can have side effects that can affect up to 30% of patients. For these and other reasons, some women refuse therapy with progestins or estrogen-progestins, preferring to resort to no treatment.

Considering the need to research effective molecules in the prevention of relapses that can maintain fertility and avoid unwanted effects, the research focuses on natural molecules, well tolerated by the body.

D-Chiro-Inositol (DCI) is a polyol normally present in human cell membranes, where, from a metabolic point of view, it acts as a second messenger of insulin, while from a hormonal point of view, it exerts an on the biosynthesis of androgens. This effect on steroidogenesis can be attributed to more than one mechanism. In the ovary, DCI stimulates direct testosterone production. Furthermore, it stimulates the accumulation of testosterone by reducing the activity of the aromatase enzyme, responsible for the conversion of androgens into estrogens. Considering the responsiveness of endometriosis to estrogens, and that these constitute a risk factor for recurrences following surgical removal, the use of DCI could be interesting from a clinical point of view.

The study plans to verify whether D-Chiro-Inositol dietary supplementation can be effective in reducing systemic estrogen levels in women with endometriosis, thus also reducing the risk of relapses and associated symptoms. conditions: Endometriosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized placebo-controlled trial primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participants and investigators will be masked to the treatment allocation. Treatment pills and placebo pills will be the same in shape, taste, color, and size. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 32 type: ESTIMATED name: D-Chiro-Inositol name: Placebo measure: Estradiol measure: Pelvic pain sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: "Paolo Giaccone" Hospital status: RECRUITING city: Palermo zip: 90127 country: Italy name: Antonio Simone Laganà, M.D., Ph.D. role: CONTACT name: Pietro Serra, M.D. role: SUB_INVESTIGATOR name: Giuseppe Mascellino, M.D. role: SUB_INVESTIGATOR name: Andrea Etrusco, M.D. role: SUB_INVESTIGATOR lat: 38.13205 lon: 13.33561 hasResults: False

 nctId: NCT06314113 id: EGCG-HPV briefTitle: Evaluation of Oral EGCG Treatment for L-SIL Associated With HPV Infection acronym: EGCG-HPV overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-09-01 date: 2024-03-15 date: 2024-03-15 name: University of Palermo class: OTHER briefSummary: The study aims to evaluate the effectiveness of the synergy of oral Epigallocatechin Gallate as a treatment for Low-grade Cervical Lesions (L-SIL) associated with Human Papilloma Virus (HPV) infection. conditions: Low-Grade Intraepithelial Neoplasia of Cervix studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED name: Epigallocatechin Gallate measure: Persistence sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: "Paolo Giaccone" Hospital status: RECRUITING city: Palermo zip: 90127 country: Italy name: Antonio Simone Laganà, M.D., Ph.D. role: CONTACT phone: +39 3296279579 email: antoniosimone.lagana@unipa.it name: Giuseppe Mascellino, M.D. role: SUB_INVESTIGATOR name: Pietro Serra, M.D. role: SUB_INVESTIGATOR name: Andrea Etrusco, M.D. role: SUB_INVESTIGATOR lat: 38.13205 lon: 13.33561 hasResults: False

 nctId: NCT06314100 id: IP-2020-02-4027-EB briefTitle: The Effect of Aerosol Formed From Tobacco Heating Systems on the Microbiome of Supragingival Dental Biofilm overallStatus: COMPLETED date: 2021-10-01 date: 2023-10-25 date: 2023-10-25 date: 2024-03-15 date: 2024-03-15 name: University of Rijeka class: OTHER name: Croatian Science Foundation briefSummary: Dental caries is a multifactorial disease primarily caused by supragingival dental biofilm. Its progression is influenced by many environmental factors, which include smoking. Tobacco heating systems (THS) are a novel tobacco product whose effect on the microbiome of the supragingival dental biofilm has not yet been investigated.

The aim of the proposed research is to determine and compare the composition of the microbiomes of the supragingival dental biofilm of THS smokers, cigarette smokers, and nonsmokers using the Next Generation Sequencing method and to assess and compare the risk of new caries lesion formation between the test groups using the Cariogram method.

The results of this research will provide insight into changes in the microbiome of the supragingival dental biofilm resulting from exposure to aerosols from tobacco combustion and tobacco heating. conditions: Dental Caries studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 60 type: ACTUAL name: Tobacco heating systems name: cigarette smoking name: non smoking measure: diversity of bacterial species measure: abundance of bacterial species measure: caries risk sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of dental medicine, University of Rijeka city: Rijeka country: Croatia lat: 45.32674 lon: 14.44239 hasResults: False

 nctId: NCT06314087 id: Neoantigen Radiotherapy briefTitle: iTAPVR Study - Phase II Randomized Study overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-08 date: 2026-08 date: 2024-03-15 date: 2024-03-15 name: The University of Hong Kong-Shenzhen Hospital class: OTHER briefSummary: In this study, the investigators provide an individualized tumor neoantigen peptide vaccine in combination with radiotherapy to patients with advanced malignant solid tumors. The investigators observe the post-treatment tumor burden status, the immune response induced by immune preparations, and the prolongation of patient survival time, aiming to evaluate the effectiveness and safety of the individualized tumor neoantigen peptide vaccine in combination with radiotherapy conditions: Advanced Tumors studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE maskingDescription: Randomized count: 154 type: ESTIMATED name: Placebo + conventional treatment including radiotherapy name: Radiation: Radiation Therapy；Biological: Personalized tumor peptide vaccine measure: Progression free survival sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06314074 id: 2023-101143-BO-ff briefTitle: 2.5 Versus 5 Minutes Trial overallStatus: RECRUITING date: 2024-03-12 date: 2025-03 date: 2025-04 date: 2024-03-15 date: 2024-04-01 name: Universitätsklinikum Hamburg-Eppendorf class: OTHER briefSummary: This is a randomized trial investigating the effect of oscillometric blood pressure monitoring at 2.5-minute intervals - compared to 5-minute intervals - on intraoperative hypotension. Specifically, the investigators will test the primary hypothesis that oscillometric blood pressure monitoring at 2.5-minute intervals - compared to 5-minute intervals - reduces the time-weighted average mean arterial pressure below 65 mmHg in patients having non-cardiac surgery. conditions: Hypotension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 264 type: ESTIMATED name: Oscillometric blood pressure monitoring at 2.5-minute intervals name: Oscillometric blood pressure monitoring at 5-minute intervals measure: Time-weighted average mean arterial pressure <65 mmHg measure: Episodes of a mean arterial pressure <50 mmHg measure: Norepinephrine dose sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf status: RECRUITING city: Hamburg zip: 20246 country: Germany name: Karim Kouz, Dr role: CONTACT phone: +49 40 7410 52415 email: k.kouz@uke.de lat: 53.57532 lon: 10.01534 hasResults: False

 nctId: NCT06314061 id: WARD-glucose RCT v.2.2 briefTitle: The Effect of Continuous Glucose Monitoring in Surgical Patients With Diabetes. acronym: WARD-glucose overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-07-01 date: 2026-01-01 date: 2024-03-15 date: 2024-03-15 name: Christian S. Meyhoff class: OTHER name: Rigshospitalet, Denmark name: Steno Diabetes Center Copenhagen name: Zealand University Hospital briefSummary: The goal of this randomised controlled trial to investigate the effect of continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in surgical patients with diabetes in patients.

The main question it aims to answer is:

• Can the use of the CGM device Dexcom G7 with real-time alerts on dysglycaemia increase the time in range for glucose levels as compared with standard monitoring with point-of-care blood glucose in surgical patients with diabetes?

Participants will be asked to wear a CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital. For patients in the intervention group, deviations of glucose levels will provide the nursing staff with alerts. All patients will receive standard care of their diabetes. The CGM device will be worn for up to 10 days or until discharge. conditions: Diabetes Mellitus conditions: Dysglycemia conditions: Perioperative Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel, 2-group randomised trial blinded for participants primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants will not be alerted of dysglycaemia by the Dexcom G7 application, which will be muted. Thus, the alerts on deviating glucose levels will only be given to the care provider (the nursing staff at the ward) whoMasked: PARTICIPANT count: 200 type: ESTIMATED name: Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7) measure: Time in range (TIR) of CGM glucose levels measure: Duration of hypoglycaemia measure: Duration of hyperglycaemia measure: Number of hypoglycaemia events measure: Number of hyperglycaemia events measure: Complications measure: Serious adverse events measure: Serious adverse Device-related events measure: Adverse events measure: Length of stay measure: Readmission measure: ICU admission measure: Days alive and out of hospital measure: Patient experience measure: Staff experience sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet city: Copenhagen state: The Capital Region Of Denmark zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 facility: Department of Anaesthesiology and Intensive Care, Bispebjerg Hospital city: Copenhagen state: The Capital Region Of Denmark zip: 2400 country: Denmark lat: 55.67594 lon: 12.56553 facility: Zealand University Hospital city: Køge zip: 4600 country: Denmark name: Annelotte Philipsen, MD, PhD role: CONTACT email: annph@regionsjaelland.dk lat: 55.45802 lon: 12.18214 hasResults: False

 nctId: NCT06314048 id: 74212 briefTitle: 4T Sustainability Program overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-01 date: 2026-01 date: 2024-03-15 date: 2024-04-15 name: Stanford University class: OTHER briefSummary: The goal of the 4T program is to implement proven methods and emerging diabetes technology into clinical practice to sustain tight glucose control from the onset of type 1 diabetes (T1D) and optimize patient-reported and psychosocial outcomes. The investigators will expand the 4T (Teamwork, Targets, Technology, and Tight Control) program to all patients seen at Stanford Pediatric Diabetes Endocrinology as the standard of care. Disseminating the 4T program as the standard of care will optimize the benefits of diabetes technology by lowering HbA1c, improving PROs, and reducing disparities. conditions: Type1diabetes studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 1. Implement the 4T program as standard of care at Stanford Diabetes clinics, including Continuous Glucose Monitoring (CGM) and Remote Patient Monitoring (RPM) within the first 30 days after T1D diagnosis to reduce the rise in HbA1c trajectory observed 4-12 months post-diagnosis.
2. Continue refining automated decision-support tools that use CGM data to support setting personalized goals and identify the need for insulin dose adjustments between quarterly endocrinology standard of care visits. Continue to evaluate the use of the Timely Interventions for Diabetes Excellence (TIDE) tool to analyze and prioritize the CGM data of participants requiring review.
3. Continue the systematic screening for patient-reported outcomes, both assessment of PROs and delivery of care linked to screening as a core component of the 4T program. primaryPurpose: OTHER masking: NONE count: 5000 type: ESTIMATED name: CGM and RPM measure: HbA1c trajectory observed 4-12 months post-diagnosis measure: Diabetes distress measured at baseline and 12 months post-diagnosis. sex: ALL minimumAge: 6 Months maximumAge: 21 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06314035 id: CIC2023003 briefTitle: Decision Support on End-of-life Care Planning in Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2024-12-31 date: 2025-01-31 date: 2024-03-15 date: 2024-03-18 name: National Taipei University of Nursing and Health Sciences class: OTHER name: Chinese University of Hong Kong briefSummary: This study aims to test the effects of a patient decision aid (PDA) on planning for end-of-life (EOL) care among older adults with COPD. The main questions it aims to answer are:

1. Does a PDA improve the process of a person to make decisions on EOL care?
2. Does a PDA improve the readiness of a person to join advance care planning (ACP) communication?
3. Does a person make an advance directive after using a PDA?

Participants in this study will:

1. Be randomly assigned to one of two groups.
2. In the experimental group, participants will receive two 60-minute interactive consultations over four weeks, using a PDA to help clarify values and preferences for future medical care. A guidebook summarising these future care options will be provided.
3. In the control group, participants will receive two 60-minute sessions on lifestyle modification and self-care management over four weeks using a guidebook with coaching. A guidebook summarising general health information will be provided.

Researchers will compare the intervention group to the control group to see if the PDA is better at improving the decision-making process on EOL care, the readiness of a person to join ACP communication and the chance to make an advance directive. conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE maskingDescription: Participants will be blinded to their group assignment. The personnel administering the interventions will not be blinded whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: COPD Patient Decision Aid name: General Health Coaching Intervention measure: Patients' decisional conflict regarding EOL care measure: Patients' confidence level regarding three ACP actions - namely, appointing a surrogate and discussing EOL care with a surrogate and medical doctors. measure: Patients' readiness for ACP measure: Participant's completion of an Advance Directive (AD) measure: Participants' understanding of the PDA measure: Participant's subjective clarity of content, comfort during reading and viewing, and the usefulness of the information of the PDA. measure: Semi-structured Interviews sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06314022 id: 22-PI113 briefTitle: A Mobile Application to Improve the Quality of Colonoscopy in Colorectal Cancer Screening Program (PrepColon APP) acronym: PREPCOLON overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2025-12-30 date: 2025-12-30 date: 2024-03-15 date: 2024-03-18 name: Hospital del Río Hortega class: OTHER briefSummary: Colonoscopy is the gold standard for the diagnosis and resection of preneoplastic lesions, allowing the prevention of colon cancer. A colonoscopy is more efficient with proper preparation of the colon, as it allows for a higher rate of adenoma detection and cecal intubation. In routine practice, up to 30% of colonoscopies are poorly prepared and 11% of patients do not show up for their appointment. Adenomas not visualized in the initial colonoscopy due to poor preparation reached 68% and the rate of undetected cancers was 66.7%. A proper colon cleanse is conditioned by different factors; among them, failure to comply with the diet and take laxatives poses 5 times the risk of having a deficient colon preparation. The purpose of our study is the design and implementation of an app that facilitates the preparation of colonoscopy and evaluates its impact on compliance with diet and laxative intake. conditions: Colorectal Cancer conditions: Premalignant Colon Lesions studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Each subject will be randomized into two groups according to the instructions given to perform the preparation of the colon prior to colonoscopy: group A: perform the preparation with the written instructions delivered in the consultation and group B: they will be given the instructions in writing and will also be indicated how to install the APP. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Patients who agree to participate in the study are randomized by a 1:1 block computer program (an attempt will be made to balance the groups according to the type of laxative) into two groups: group A: control group, which receives the standard information given in writing, and group B: APP group, which receives the standard information together with the mobile application individually adapted to the scheduled colonoscopy appointment and the type of laxative.

Patients scheduled for a screening colonoscopy will be contacted by telephone, those who agree to participate will be scheduled with the nurse, after giving their consent they are randomized. Group B will indicate how to download the APP and its management. The endoscopist performing the examination is blind for randomization and will assess colon cleansing according to the Boston Bowel Scale (Lai EJ. et al Gastroinest Endosc 2009). whoMasked: INVESTIGATOR count: 470 type: ESTIMATED name: Mobile application for colonoscopy preparation instructions measure: Compliance with the diet and intake of laxatives with the use of a mobile application measure: Evaluate the quality of colon cleansing with mobile application as an experimental factor measure: Assessment of the usability of the APP measure: Compliance with the laxative intake with the use of the mobile application measure: Assessment of the difficulty of the preparation instructions measure: Evaluate colonoscopy quality indicators: measure: Evaluate attendance at the scheduled colonoscopy appointment measure: Evaluate colonoscopy quality indicators sex: ALL minimumAge: 50 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Rio Hortega city: Valladolid zip: 47012 country: Spain lat: 41.65518 lon: -4.72372 hasResults: False

 nctId: NCT06314009 id: EH23-302 briefTitle: Beyond MARS: Magnetic Resonance Study: A Novel Assessment of Placental Perfusion During Pregnancy overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-12 date: 2026-12 date: 2024-03-15 date: 2024-03-15 name: NorthShore University HealthSystem class: OTHER briefSummary: The purpose of this study is to evaluate the flow of oxygen and blood necessary for nutrient transfer across the placenta during the second and third trimesters in pregnancy in women who are obese before pregnancy compared to women who have an average weight before pregnancy. This study will evaluate blood flow across the placenta by functional Magnetic Resonance Imaging (fMRI) using arterial spin labeling (ASL). The investigators hypothesize that there will be differences in placental oxygenation and blood flow among women with obesity as compared to those with normal weight. Participants will be asked to complete Magnetic Resonance Imaging scans (MRIs), the first in the second trimester at 20-24 weeks and the second in the third trimester at 30-34 weeks. conditions: Placenta Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: functional Magnetic Resonance Imaging (fMRI) measure: Inter - rater reliability of assessing placental blood flow by arterial spin labeling (ASL) measure: Mean placental perfusion in second and third trimester measure: Mean R2* relaxation rates in second and third trimester measure: Perinatal outcomes including hypertensive disorders of pregnancy, gestational diabetes, preterm birth, small for gestational age, NICU admission, and stillbirth. sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06313996 id: CA082-011 id: 2023-507477-18 type: EUDRACT_NUMBER briefTitle: A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-03-29 date: 2031-10-16 date: 2031-10-16 date: 2024-03-15 date: 2024-03-15 name: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company class: INDUSTRY name: Celgene Corporation briefSummary: The purpose of this study is to evaluate the efficacy and safety of Liso-cel compared to standard of care in adults with Relapsed or Refractory Follicular Lymphoma. conditions: Relapsed or Refractory Follicular Lymphoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Cyclophosphamide name: Doxorubicin name: Vincristine name: Rituximab name: Prednisone name: Bendamustine name: Lenalidomide name: Fludarabine name: Liso-cel measure: Progression-free survival (PFS) measure: Complete response (CR) measure: Overall survival (OS) measure: Overall response (OR) measure: Duration of response (DOR) measure: Event-free survival (EFS) measure: Time to next anti-cancer therapy (TTNLT) measure: PFS rate measure: EFS rate measure: OS rate measure: Progression-free survival on the next line of treatment (PFS-2) measure: Number of participants with adverse events (AEs) measure: Number of participants with adverse event of special interest (AESIs) measure: Number of participants with serious adverse events (SAEs) measure: Number of participants with laboratory abnormalities measure: Frequency and length of hospitalizations measure: Number of participants with intensive care unit (ICU) inpatient days measure: Number of participants with non-ICU inpatient days measure: Mean change from baseline in key health-related quality of life (HRQoL) domains. measure: Time to meaningful improvement/deterioration in key HRQoL domains. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06313983 id: HM022BC3C01 briefTitle: A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer overallStatus: RECRUITING date: 2022-01-08 date: 2025-12 date: 2026-06 date: 2024-03-15 date: 2024-03-15 name: Tianjin Hemay Pharmaceutical Co., Ltd class: INDUSTRY briefSummary: The purpose of this study is to evaluate the effectiveness of Hemay022 combined with AI (exemestane or letrozole) in the treatment of ER+/HER2+ advanced breast cancer patients based on the progression-free survival (PFS) assessed by the independent review committee (IRC). The second purpose of this study is to evaluate the pharmacokinetics and efficacy of Hemay022 in combination with AI, and the safety of Hemay022 in combination with AI.

The trial plans to recruit 339 subjects, who will be randomly divided into two cohorts (the experimental group is hemay022 combined with AI, and the control group is lapatinib combined with capecitabine). During the treatment period, imaging examinations and anti-tumor efficacy evaluations will be performed regularly until the subject develop disease progression or starts receiving other treatments or dies or refuses to come to the hospital for follow-up or the trial is terminated, etc. conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 339 type: ESTIMATED name: Hemay022+AI name: Lapatinib+Capecitabine measure: Median progression-free survival（mPFS）based on IRC assessment according to RECIST v1.1 measure: Overall Survival (OS) of the two group according to RECIST v1.1 measure: Objective response rate ( ORR, partial response rate+ complete response rate) according to RECIST v1.1 measure: Clinical benefit rate (CBR) according to RECIST v1.1 measure: Duration of Response (DOR) according to RECIST v1.1 measure: Time to Response (TTR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital status: RECRUITING city: Beijing country: China name: Huiping Li role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06313970 id: QLMA-PC-IIT-001 briefTitle: First-line Regimen With QL1706 Plus Chemo ± Bev in PDAC Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-15 date: 2026-04-15 date: 2024-03-15 date: 2024-03-15 name: Fudan University class: OTHER briefSummary: This is a multicenter, open-label, exploratory study to evaluate the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine with or without bevacizumab as first-line treatment in patients with unresectable locally advanced or metastatic pancreatic cancer conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: QL1706 name: Nab-paclitaxel name: Gemcitabine name: Bevacizumab measure: Objective response rate (ORR) measure: Disease control rate (DCR) measure: Duration of Response (DoR) measure: Time to response(TTR) measure: Progression-free survival (PFS) measure: Overall survival（OS） measure: Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06313957 id: LB2302-0001 briefTitle: A Study of LUCAR-20SP in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma overallStatus: RECRUITING date: 2024-03 date: 2026-09 date: 2028-09 date: 2024-03-15 date: 2024-03-15 name: Peking University Cancer Hospital & Institute class: OTHER briefSummary: This is a prospective, single-arm, open-label, exploratory clinical study of LUCAR-20SP in adult subjects with relapsed/refractory B-cell non-Hodgkin lymphoma. conditions: Relapsed/Refractory B-cell Non-Hodgkin Lymphoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: LUCAR-20SP cells measure: Dose-limiting toxicity (DLT) rate measure: Incidence, severity, and type of treatment-emergent adverse events (TEAEs) measure: Recommended Phase 2 Dose (RP2D) regimen finding measure: Pharmacokinetics in peripheral blood measure: Pharmacokinetics in bone marrow measure: Objective Response Rate (ORR) after administration measure: Time to Response (TTR) after administration measure: Duration of Remission (DoR) after administration measure: Progression-free Survival (PFS) after administration measure: Overall Survival (OS) after administration measure: Incidence of anti-LUCAR-20SP antibody sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Cancer Hospital & Institute status: RECRUITING city: Beijing state: Beijing zip: 100142 country: China name: Yuqin Song role: CONTACT phone: 13683398726 email: songyq22622@163.com name: Yan Xie role: CONTACT phone: 13671376201 email: xieyan9@263.net name: Yuqin Song role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06313944 id: GE-R-A-TPS briefTitle: German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation acronym: GE-R-A-TPS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-10-01 date: 2026-10-01 date: 2024-03-15 date: 2024-03-15 name: Heinrich-Heine University, Duesseldorf class: OTHER name: Storz Medical AG briefSummary: This study will primarily investigate the safety and secondarily the effect and applicability of Transcranial Pulse Wave Stimulation (TPS) for the treatment of Alzheimer's disease in the context of a PMCF study (Post-Market Clinical Follow-up). The multicenter, prospective data collection should help to optimize the stimulation protocol, as well as to record frequent to occasional adverse effects of the product and cognitive, affective and subjective scores. conditions: Alzheimer Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Registry measure: Number of (Serious) Adverse Events measure: Number of adverse device effects measure: ADAS measure: Mini Mental State Examination (MMSE) baseline and follow- up measure: BDI-II measure: Clinical Dementia Rating Sum of Boxes Score (CDR-SB) measure: Alzheimer's Disease Cooperative Study/ Activities of Daily Living Scale (ADCS-ADL) measure: Numeric Rating Scale (NRS) for the main symptom sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06313931 id: UTI-IIDI-074-2023 briefTitle: Effects of Cognitive-motor Training on Cognition, Depression and Daily Functioning in Patients With Mild Cognitive Impairment (MCI) overallStatus: COMPLETED date: 2023-07-03 date: 2023-09-14 date: 2023-09-14 date: 2024-03-15 date: 2024-03-15 name: Universidad de Zaragoza class: OTHER briefSummary: This randomized controlled trial evaluated the effectiveness of an immersive virtual reality (IVR) application (focused on a daily activity) to train cognitive functions and its impact on depression and the ability to perform activities of daily living (ADL) in patients with mild cognitive impairment (MCI). With a dose of two sessions per week during six weeks, the study showed significant improvements in cognitive functions and reduction in depression, with notable effects in the experimental group. This underscores the potential of IVR as a valuable tool in the management of MCI. conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 26 type: ACTUAL name: cognitive training via immersive virtual reality name: cognitive training via paper and pencil name: motor stimulation measure: Spanish version of the Montreal Cognitive Assessment (MoCA-S) measure: Short Geriatric Depression Scale (SGDS-S) measure: Instrumental Activities of Daily Living Scale (IADL-S) sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: University of Zaragoza city: Teruel zip: 44003 country: Spain lat: 40.3456 lon: -1.10646 hasResults: False

 nctId: NCT06313918 id: REK nr. 428096 briefTitle: Exercise Therapy in Mental Disorders-study overallStatus: RECRUITING date: 2023-09-27 date: 2026-09-26 date: 2026-09-26 date: 2024-03-15 date: 2024-03-15 name: Haukeland University Hospital class: OTHER briefSummary: The study will compare standard high-intensity training with brief high-intensity training in people with schizophrenia-spectrum or bipolar disorder. The overall aim is to determine which of the two is superior in a long-term perspective. conditions: Schizophrenia and Related Disorders conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Open label, two-arm, parallel group, randomised trial, to compare standard and short HIT during 26 weeks of supervised exercise. The group will receive comprehensive follow-up to be able to carry out the 26 weeks exercise intervention program. Outcome measures will be taken at; baseline (T0), 4 weeks (T1), 12 weeks (T2), 26 weeks (T3), and 52 weeks (T4) post randomisation. primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: High intensity training (HIT) measure: Adherence measure: Change of the Simplified Negative and Positive Symptoms Interview (SNAPSI) score measure: Change of the Calgary Depression Scale in Schizophrenia score measure: Change of the Clinical Global Impression (CGI) score measure: Change of the Global Assessment of Funtioning (GAF) score measure: Change of quality of life (QOL10) score measure: Change of the International Physical Activity Questionaire (IPAQ) score measure: Change of the Brief Assessment of Cognition in Schizophrenia (BACS) score measure: Change of the Behavioural Regulation in Exercise Questionaire (BREQ) score measure: Change of the Difficulties in Emotion Regulation (DERS) score measure: Change in heart rate (beats per minute) measure: Change of maximal oxygene extraction (VO2max) measure: Change of level of inflammatory markers in blood measure: Change of body weight (kilograms) measure: Change of hip- and waist circumference (centimetres) measure: Change of serum glucose (mmol/L) measure: Change of serum cholesterols (mmol/L) measure: Change of serum triglyceride (mmol/L) measure: Change of gene expression measure: Change of methylation of DNA measure: Change of the Young Mania Rating Scale (YMRS) score sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Haukeland University Hospital status: RECRUITING city: Bergen zip: 5020 country: Norway name: Erik Johnsen, MD, PhD role: CONTACT phone: +47 55958400 email: erik.johnsen@helse-bergen.no name: Rune A Kroken, MD, PhD role: CONTACT phone: +47 55958400 email: rune.andreas.kroken@helse-bergen.no lat: 60.39299 lon: 5.32415 hasResults: False

 nctId: NCT06313905 id: DRYLESS1 id: CHU La Rabta type: OTHER domain: La Rabta hospital briefTitle: EVADRY® in the Treatment of Xerostomia in Sjögren's Syndrome acronym: DRYLESS overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2025-12-31 date: 2024-03-15 date: 2024-03-15 name: University Tunis El Manar class: OTHER briefSummary: Xerostomia is a common and very bothersome manifestation that impairs the quality of life in Sjogren's syndrome. Symptomatic therapeutic alternatives for this syndrome are limited in Tunisia. We resort to bromhexine off-label with low efficacy. The aim of this work is to demonstrate the superiority of a treatment based on dietary supplements (EVADRY) vs placebo in the treatment of xerostomia. This is a double-blind randomized clinical trial with 2 arms: an EVADRY arm (n=90) and a placebo arm (n=90). The primary outcome measure is a 35% increase in salivary flow after 3 months. Secondary outcome measures were based on the Oral Health Impact Profile questionnaire, Xerostomia Inventory, the HAD depression scale, and the buccal Schirmer test. conditions: Sjogren's Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: double-blind randomized study primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: EVADRY name: Placebo measure: salivary flow rate (SFR) measure: Xerostomia Inventory in French version measure: Oral Health-related quality of life (OHIP-14) questionnaire measure: Hospital anxiety and depression (HAD) scale measure: Buccal Schirmer test sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06313892 id: PA24HD-2-05 briefTitle: The Effect of Home Based Tel-Exercise on Dialysis Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-15 date: 2024-06 date: 2024-06 date: 2024-03-15 date: 2024-04-22 name: Pardis Specialized Wellness Institute class: OTHER briefSummary: The objective of the trial is to assess key areas of uncertainty regarding the use of synchronous home-based tele exercise in future practice and research, including issues relating to feasibility, safety and potential for efficacy. conditions: End Stage Renal Disease conditions: Hemodialysis Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly allocate to intervention group or control group and will be examined in the same way. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: A research project collaborator who is not informed about grouping of participants will obtain outcome measurements of the functional test. Outcome adjudicators, and data analysts will be kept blinded to the allocation. Moreover, all investigators, staff, and participants will be kept masked to outcome measurements and trial results. whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Home based Exercise measure: Recruitment rate measure: Retention rates measure: Adherence rate measure: Rate of changes of daily physical activity level measure: Rate of changes of Frailty level measure: Rate of changes of physical function level sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Khorshid Dialysis Center city: Isfahan country: Iran, Islamic Republic of lat: 32.65246 lon: 51.67462 facility: Pardis specialized wellness institute city: Isfahan country: Iran, Islamic Republic of lat: 32.65246 lon: 51.67462 hasResults: False

 nctId: NCT06313879 id: PamukkaleU-SBE-SA-01 briefTitle: The Effect of Education Given to Parents of Children With Ventriculoperitoneal Shunt on Their Anxiety and Self-efficacy overallStatus: RECRUITING date: 2024-03-10 date: 2025-02 date: 2025-02 date: 2024-03-15 date: 2024-03-15 name: Pamukkale University class: OTHER briefSummary: This study aims to evaluate the effect of tele-education given to parents of children with ventriculoperitoneal shunt on their anxiety and self-efficacy. conditions: Hydrocephalus in Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups: comparative experiment and control primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: online education measure: State and Trait Anxiety Scale measure: General Self-Efficacy Scale sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Pamukkale University Hospital status: RECRUITING city: Denizli zip: 20180 country: Turkey name: Sevinç Aka role: CONTACT phone: +905057323842 email: sevincakaa@gmail.com lat: 37.77417 lon: 29.0875 hasResults: False

 nctId: NCT06313866 id: 2024ZL368 briefTitle: the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in PSCI overallStatus: RECRUITING date: 2023-12-20 date: 2024-12-01 date: 2025-02-01 date: 2024-03-15 date: 2024-03-15 name: Hangzhou Medical College class: OTHER briefSummary: The patients with cognitive impairment after stroke were divided into control group, electroacupuncture group, olfactory therapy group, and electroacupuncture combined with olfactory therapy group, with 35 people in each group. After the end of the treatment, the clinical efficacy was evaluated. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: control name: Electronuchal acupuncture group treatment name: Smell therapy group treatment name: Electronuchal acupuncture combined with smell and inhalation therapy group treatment measure: MMSE measure: MoCA measure: MBI measure: TCD measure: Near-infrared functional imaging of the brain measure: Magnetic resonance scanning sex: ALL maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College. status: RECRUITING city: Hangzhou state: Zhejiang zip: 311000 country: China name: Xinyun Dr LI, Doctor role: CONTACT phone: 8618069783240 email: lxyjasmine2010@163.com lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06313853 id: STUDY00007068 briefTitle: Enhancing Triadic Communication About Cognition for Older Adults With Alzheimer's Disease or Related Dementias Facing a Cancer Management Decision acronym: COACH-Cog overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2027-03 date: 2027-09 date: 2024-03-15 date: 2024-03-15 name: University of Rochester class: OTHER name: National Institute on Aging (NIA) briefSummary: Building upon prior work, the investigator team developed a communication intervention for older adults with ADRD who are considering a decision about cancer management (adapted intervention: COACH-Cog). The investigators hypothesize that for patients with dual diagnoses of ADRD and cancer, COACH-Cog will increase autonomy support of care partners and patients in the decision-making process, leading to greater acknowledgement and support of cognitive concerns and cognitive-related goals, thereby improving goal concordant care. The investigators are conducting a pilot randomized controlled trial (RCT; cluster randomized by physician) including approximately 45 oncology clinicians and 130 patient/care partner dyads evaluating the effect of COACH-Cog on care partner and patient autonomy support, care partner well-being, goal-concordance, and communication. conditions: Cancer conditions: Dementia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cluster-randomized primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 305 type: ESTIMATED name: COACH-Cog measure: Care Partner: Health Care Climate Questionnaire (HCCQ) measure: Montgomery Borgatta Caregiving Burden Scale measure: World Health Organization Quality of Life Brief Version (WHOQOL-BREF) measure: Care Partner PROMIS Depression measure: Care partner PROMIS Anxiety measure: Care partner: Patient-Centered Communication in Cancer Care (PCC-Ca) measure: Care partner: Health Care Climate Questionnaire - Age (HCCQ-Age) measure: Care partner: Qualitative assessment of goal concordance measure: Care partner: Decision Regret Scale measure: Patient: Patient-Centered Communication in Cancer Care (PCC-Ca) measure: Patient: Health Care Climate Questionnaire (HCCQ) measure: Patient: Health Care Climate Questionnaire - Age (HCCQ-Age) measure: Patient Decision Regret Scale measure: Physician Decision Regret Scale sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: University of Rochester Wilmot Cancer Institute city: Rochester state: New York zip: 14620 country: United States name: Allison Magnuson, DO, MS role: CONTACT email: Allison_magnuson@urmc.rochester.edu name: Jessica Bauer role: CONTACT email: JessicaC_Bauer@URMC.Rochester.edu lat: 43.15478 lon: -77.61556 hasResults: False

 nctId: NCT06313840 id: CIP3125 briefTitle: Central Sleep Apnea Prevalence and Impact on Cognitive Function in Patients With Heart Failure With Reduced or Mildly Reduced Left Ventricular Ejection Fraction acronym: COG01 overallStatus: RECRUITING date: 2023-08-21 date: 2024-09-30 date: 2024-11-30 date: 2024-03-15 date: 2024-03-15 name: Zoll Medical Corporation class: INDUSTRY briefSummary: Study to assess the prevalence of central sleep apnea in patients with heart failure with reduced or mildly reduced left ventricular ejection fraction (LVEF \<50%) followed by case-control study to assess the link between central sleep apnea and cognitive function conditions: Heart Failure conditions: Central Sleep Apnea studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Prevalence of CSA in tested HFrEF/HFmrEF patients measure: Difference in cognitive function scores between the HFrEF/HFmrEF CSA and no SDB groups using the CANTAB assessment. sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Przychodnia na Teczowej status: RECRUITING city: Wrocław country: Poland name: Anna Basinska role: CONTACT name: Ewa Jankowska role: PRINCIPAL_INVESTIGATOR lat: 51.1 lon: 17.03333 facility: Szpital Uniwersytecki we Wrocławiu status: RECRUITING city: Wrocław country: Poland name: Anna Basinska role: CONTACT name: Ewa Jankowska role: PRINCIPAL_INVESTIGATOR lat: 51.1 lon: 17.03333 hasResults: False

 nctId: NCT06313827 id: UV-INV_3165929 briefTitle: e-Health Program to Prevent Exacerbations in the Cystic Fibrosis Population overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-01 date: 2025-06 date: 2024-03-15 date: 2024-03-15 name: University of Valencia class: OTHER name: Asociación de Fibrosis Quística - Comunidad Valenciana briefSummary: The goal of this clinical trial is to analyse the impact of a telematic assessment and monitoring protocol in people with cystic fibrosis, in order to identify exacerbations early, thus preventing loss of lung function and maintaining quality of life.

Participants will be assigned to one of 3 study groups:

Control group (CG-1): will receive their usual physiotherapy treatment; Treatment group (TG-2): will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment; Treatment and follow-up group (TGF-3): will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment, plus telematic control of exacerbations with feedback from the physiotherapist. conditions: Cystic Fibrosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Participants will be randomly assigned to one of three study groups by the person conducting the intervention.

All participants receive usual physiotherapy treatment, and both intervention groups receive monitoring and follow-up of their clinical situation.

The evaluators are unaware of the assignment at all times. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Exercise plus Monitoring Group (TG-2) name: Exercise plus monitoring and follow-up group (TGF-3) name: Exercise Group (CG-1) measure: Clinical exacerbation measure: Dyspnea measure: Spirometric function measure: Oxigenation measure: Functional capacity measure: Quality of life (QoL) measure: Motivation to engage in physical activity sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Universitat de Valencia city: Valencia zip: 46010 country: Spain name: Francisco Martinez Arnau, PhD role: CONTACT name: Anna Arnal Gomez, PhD role: SUB_INVESTIGATOR name: Sara Cortes Amador, PhD role: PRINCIPAL_INVESTIGATOR name: Francisco Martínez Arnau, PhD role: SUB_INVESTIGATOR name: Carlos Gomez Chinesta, PT role: SUB_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06313814 id: DE RKEB/IKEB 5622-2020 briefTitle: The Effect of Ginger on Functional Dyspepsia Symptoms and Body Fat Content Among Patients With Functional Dyspepsia overallStatus: ENROLLING_BY_INVITATION date: 2023-06-01 date: 2025-01 date: 2025-12 date: 2024-03-15 date: 2024-04-12 name: University of Debrecen class: OTHER briefSummary: The goal of this clinical trial is to assess ginger's effect on patients with functional dyspepsia.

The main question\[s\] it aims to answer are:

1. Does ginger intake improve functional dyspepsia symptoms?
2. Does ginger intake decrease the body fat content among patients with functional dyspepsia? Dyspepsia patients will be asked to take 540 mg of ginger capsule twice a day. Researchers will assess if there is an improvement in the symptoms of the disease and the fat content. \[ to see if gingers effect. conditions: Functional Dyspepsia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 62 type: ESTIMATED name: Swanson ginger capsule measure: Functional Dyspepsia Symptom Severity measure: Body Fat Content Analysis measure: Improvement in Quality of Life sex: ALL minimumAge: 18 Years maximumAge: 72 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Debrecen city: Debrecen zip: 4032 country: Hungary lat: 47.53333 lon: 21.63333 hasResults: False

 nctId: NCT06313801 id: DPNCD-2309 briefTitle: Comparing the Safety and Efficacy of First-line Polychemotherapy and Polychemotherapy in Combination With PIPAC Sessions overallStatus: RECRUITING date: 2023-01-19 date: 2026-01-19 date: 2026-01-19 date: 2024-03-15 date: 2024-03-15 name: Nizhny Novgorod Regional Clinical Oncology Center class: OTHER_GOV briefSummary: After the initial diagnostic laparoscopy the Control group patients undergo 6 courses of polychemotherapy according to the FLOT scheme; the examination is carried out every 3 courses (after the 3rd and the 6th courses) with the control diagnostic laparoscopy after 6 courses of polychemotherapy. In the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, the dynamic observation or cytoreductive surgery is considered (optionally); in case of the incomplete response the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy or the optimal palliative care options depending on the clinical situation is considered.

After the initial diagnostic laparoscopy the Study group patients undergo courses of polychemotherapy according to the scheme FLOT (the 1st, the 3rd, the 5th courses) and mFLOT (the 2nd , the 4th, the 6th courses) in the amount of 6 (six, 3+3); the examination is carried out every 3 courses (after the 3rd and the 6th courses) with dPIPAC sessions using docetaxel (thus excluding it from the system administration) in the 2nd , the 4th, the 6th courses of polychemotherapy. Control diagnostic laparoscopy is not performed in the group No 2, its function is performed by the revision at the PIPAC session of the 6th course of polychemotherapy, which corresponds to the time interval of the Control group. In the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, the dynamic observation or cytoreductive surgery is considered (optionally); in case of the incomplete response the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy or the optimal palliative care options depending on the clinical situation is considered. conditions: Gastric Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In the control group, after diagnostic laparoscopy, 6 courses of PCT FLOT are carried out, examination every 3 courses with the performance of control diagnostic laparoscopy after 6 courses of PCT. In the study group, after diagnostic laparoscopy, FLOT PCT courses (1st, 3rd, 5th courses), mFLOT (2nd, 4th, 6th courses) are conducted, examination every 3 courses with dPIPAC sessions with docetaxel (excluding it from systemic administration) on the 2nd, 4th, 6th courses of PCT. In group 2, the function of control laparoscopy is performed by revision at the dPIPAC session of the 6th course of PCT. In both groups, with complete regression of foci along the peritoneum and Cy- in peritoneal lavage - dynamic observation or cytoreductive surgery, with incomplete response - dynamic observation before progression, with progression - the 2nd line of CT or optimal palliative care options. primaryPurpose: TREATMENT masking: NONE count: 106 type: ESTIMATED name: Docetaxel name: Oxaliplatin name: Calcium folinate name: Fluorouracil name: Diagnostic laparoscopy name: dPIPAC ( The description of the standard diagnostic laparoscopy procedure and the session of PIPAC (dPIPAC)). measure: The progression-free survival. measure: Complications from polychemotherapy. measure: The overall survival. measure: The completeness of the planned therapy. measure: Percentage of patient conversions to Су- and PCI- rate. measure: Surgical complications of operated patients measure: Аssessment of the quality of life sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary" status: RECRUITING city: Nizhny Novgorod zip: 603126 country: Russian Federation name: Sergey Klimin role: CONTACT phone: +79875403280 email: kliminsergey7@gmail.com lat: 56.32867 lon: 44.00205 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-01-17 uploadDate: 2024-03-10T15:27 filename: Prot_SAP_000.pdf size: 393857 hasResults: False

 nctId: NCT06313788 id: EC007-2324 briefTitle: Applying a Small Procedure Prior to Injection/Vaccination Reduces Pain Experiences in Child Patients overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2026-01-01 date: 2026-01-01 date: 2024-03-15 date: 2024-03-15 name: Lingnan University class: OTHER briefSummary: Pain is common among children. Given that children are not as mature and independent in assessing or treating their pain as adults, they are a relatively vulnerable group in terms of pain management and are in need of additional attention. However, there is still insufficient recognition and treatment of pain in children. Taken the procedure of injection/vaccination in children as an example, child patients usually wait for their turn to take the injection from the nurse/doctor, during which anxiety and fear of pain develop. As children are less able to manage their pain than adults, the fear they develop during the waiting time, together with the pain they actually felt after the treatment, can bring negative experiences to them. In this proposed project, the investigators aim to apply a minor procedure prior to a treatment that induces pain (e.g., injection / vaccination) to help managing pediatric pain. conditions: Pediatric Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE maskingDescription: One group of the participants will be told that they are involved in a marketing survey and will be given a band-aid as a token of appreciation for their participation. This constitutes the mere possession group. whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Possession of a customized placebo analgesic band-aid prior to vaccination or injection measure: Pain intensity Rating (rating how much pain participants feel) measure: Pain intensity Measurement (measure how much pain participants feel) measure: Pain Threshold (record the first-time participants feel the pain) measure: Pain unpleasantness (rating how unpleasant participants feel about the pain) measure: Mood (rating the positive and negative emotions of the participants) measure: State-anxiety (Rating the participants' current anxiety level) measure: Fear of pain Rating measure: Magical thinking Rating measure: Pain Self-Efficacy measure: Self-efficacy to tackle pain measure: Expectation of Pain Severity sex: ALL minimumAge: 6 Years maximumAge: 11 Years stdAges: CHILD hasResults: False

 nctId: NCT06313775 id: SPS005 briefTitle: Comparison of Spinal Anesthesia and Spermatic Cord Block for Bilateral Orchiectomy overallStatus: ENROLLING_BY_INVITATION date: 2024-06-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-15 date: 2024-03-15 name: Sanpasitthiprasong Hospital class: OTHER_GOV briefSummary: The goal of this randomized controlled trial is to compare intraoperative pain score, Morphine consumption during 6 and 12 hour after surgery, and postoperative complications between SA and SCB groups in metastatic prostate cancer patient. The main question it aims to answer are:

• Is there a difference in the level of pain during bilateral orchiectomy between spinal anesthesia and spermatic cord block?

Participants will undergo bilateral orchidectomy. They will be randomly assigned to two groups: the group receiving spinal anesthesia and the group receiving spermatic cord block If there is a comparison group: Researchers will compare intraoperative pain score, Morphine consumption during 6 and 12 hour after surgery, and postoperative complications in both groups of patients. conditions: Orchiectomy conditions: Spermatic Cord Block conditions: Spinal Anesthesia conditions: Pain Score conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Simple random sampling primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 18 type: ESTIMATED name: bilateral orchiectomy measure: intraoperative pain score measure: post-operative pain score measure: morphine consumption measure: post-operative complications sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sanpasitthiprasong hospital city: Ubon Ratchathani zip: 33000 country: Thailand lat: 15.23844 lon: 104.84866 hasResults: False

 nctId: NCT06313762 id: Codi CEIm: 21/132-P briefTitle: Use of Virtual Reality in the Reduction of Pain After the Administration of Vaccines Among Children in Primary Care Centers. overallStatus: COMPLETED date: 2022-01-18 date: 2024-01-24 date: 2024-02-08 date: 2024-03-15 date: 2024-03-15 name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina class: OTHER briefSummary: The objective of this randomized, multicenter, open-label, parallel, controlled clinical trial is to evaluate pain reduction during the administration of two vaccines in children aged 3 and 6 years through virtual reality.

The main question\[s\] it aims to answer are:

1. To evaluate the reduction in pain during the administration of two vaccines in children aged 3 and 6 years.
2. To evaluate the reduction in anxiety during and after the administration of two vaccines in children aged 3 and 6 years.
3. Improve the satisfaction of parents or legal guardians after the administration of two vaccines in children aged 3 and 6 years.
4. Evaluate the Safety of the use of virtual reality glasses in children aged 3 and 6 years during the administration of vaccines.

The study population will include children aged 3 and 6 years who are included in the patient registry and are being seen in a primary care center of the Catalan Institute of Health in Central Catalonia.

The clinical trial has two assigned groups: a control group and an intervention group.

The intervention group will use the Pico G2 VR goggles (Pico Interactive Inc) during the administration of the two vaccines, together with an Android AOYODKG tablet, which will be connected to the goggles as a controller.

The control group participants will receive traditional distractors, such as being held by the parent or guardian who accompanies them to the appointment, receiving stickers at the end of the appointment, or receiving rewards that the parent or guardian has prepared from home.

International Registered Report Identifier (IRRID): PRR1-10.2196/35910 conditions: Pain conditions: Pediatrics conditions: Vaccination conditions: Virtual Reality studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The intervention group will use the Pico G2 VR goggles (Pico Interactive Inc) during the administration of the two vaccines, together with an Android AOYODKG tablet, which will be connected to the goggles as a controller.

The control group participants will receive traditional distractors, such as being held by the parent or guardian who accompanies them to the appointment, receiving stickers at the end of the appointment, or receiving rewards that the parent or guardian has prepared from home. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 300 type: ACTUAL name: Pico G2 Virtual Reality Glasses (Pico Interactive Inc), together with an Android AOYODKG tablet name: Traditional Distractors name: Triple Viral + Varicella Vaccine at 3 years of age name: Hepatitis A + Diphtheria-Tetanus-Pertussis Vaccine at 6 years of age. measure: Evaluation of pain perception during the administration of two vaccines in children aged 3 and 6 years, through the Wong-Baker Pain Scale. measure: Evaluation of anxiety during the administration of two vaccines in children aged 3 and 6 years, through heart rate and the Children's Fear Scale. measure: Degree of satisfaction of parents/legal guardians of minors after the administration of two vaccines, using the CSAT scale. measure: Number of patients who experienced adverse effects during the administration of vaccines and who used virtual reality glasses, through the registration of the effects presented. sex: ALL minimumAge: 3 Years maximumAge: 6 Years stdAges: CHILD facility: Catalan Institute of Health. Territorial Management of Central Catalonia. city: Manresa state: Barcelona zip: 08260 country: Spain lat: 41.72815 lon: 1.82399 hasResults: False

 nctId: NCT06313749 id: MMS-US-1 briefTitle: Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2025-12 date: 2024-03-15 date: 2024-03-15 name: Sanoculis Ltd class: INDUSTRY briefSummary: The goal of this clinical trial is to show non-inferiority of the MIMS® device/procedure with Mitomycin-C, in terms of its surgical success rate, compared to trabeculectomy with Mitomycin-C in subjects diagnosed with primary open angle glaucoma, whose intraocular pressure is not controlled despite polypharmacy.

Eligible screened participants will undergo the MIMS® procedure and will be followed for a period of 12 months in this single-arm study. Investigators will compare the results of this study to the surgical success rate of traditional trabeculectomy with Mitomycin-C. conditions: Primary Open Angle Glaucoma conditions: Open Angle Glaucoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE maskingDescription: This clinical study is observer masked only when measuring intraocular pressure (using Goldmann Applanation Tonometry). Intraocular pressure measurements will be determined using the 2-person method to reduce bias. Observer 1 (masked to real time reading) will look through the slit lamp and turn the Goldmann Tonometer dial, and Observer 2 will read and record the intraocular pressure readings. Observer 1 will be unable to see the readings with the use of a masking card. count: 129 type: ESTIMATED name: Minimally Invasive Micro Sclerostomy Device measure: Surgical success rate of the MIMS® device/procedure at 12 months after surgery measure: Exploratory Effectiveness Endpoint 1 measure: Exploratory Effectiveness Endpoint 2 measure: Exploratory Effectiveness Endpoint 3 measure: Exploratory Effectiveness Endpoint 4 measure: Safety Outcome 1 measure: Safety Outcome 2 measure: Safety Outcome 3 sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06313736 id: STU00220591_shortening id: 2T32MH115882-06A1 type: NIH link: https://reporter.nih.gov/quickSearch/2T32MH115882-06A1 briefTitle: What SSI Duration is Most Effective? An Online Experiment With American Adults overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-20 date: 2024-05 date: 2024-05 date: 2024-03-15 date: 2024-04-11 name: Northwestern University class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: In a previous study (https://osf.io/qdznc), the research team found that an 8-minute version of a single-session intervention for loneliness was more effective than a 23-minute version of it. The present work aims to further explore the relationship between intervention duration and effectiveness.

In this online trial, participants will be randomized to a 15-minute single-session depression intervention called the Action Brings Change (ABC) Program, a 10-minute version of it, a 6-minute version of it, or a 2-minute version of it. The main analysis will evaluate how change in depressive symptoms over eight weeks differs across conditions. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be assigned to one of four different conditions. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants will be aware that they will be assigned to an intervention designed to help them with depressive symptoms. They will know that the study compares multiple interventions but will not know to which arm they have been assigned. Additionally, the measures will be self-administered, so there is no scope for evaluator bias. There will be no interaction between participants and investigators. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 1100 type: ESTIMATED name: Action Brings Change Project (15-minute adult version) name: Action Brings Change Project (10-minute adult version) name: Action Brings Change Project (6-minute adult version) name: Action Brings Change Project (2-minute adult version) measure: Change in Patient Health Questionnaire-8 at 8 weeks (PHQ-8; Kroenke et al., 2009) measure: Change in Beck Hopelessness Scale at 8 weeks (BHS-4; Perczel Forintos et al., 2013) measure: Change in Beck Hopelessness Scale - 4-item at post-intervention measure: Change in UCLA Loneliness Scale 3-item version at 8-week follow-up (ULS-3; Hughes et al., 2004) measure: Presence of an "Aha! moment" at post-intervention measure: Presence of an "Aha! moment" at 8 weeks post-intervention measure: Significance of the "Aha! moment" at immediately post-intervention measure: Significance of the "Aha! moment" at 8 weeks post-intervention measure: Change in Frequency of actions and thoughts scale at post-test at 8 weeks post-intervention (FATS; Terides et al., 2016) measure: Expected improvement at post-intervention (from the Credibility / Expectancy Questionnaire; Devilly, 2004) measure: Self-reported improvement at 8-weeks post-intervention (adapted from the Credibility/ Expectancy Questionnaire; Devilly, 2004) measure: Intervention satisfaction star rating at post-intervention measure: Intervention satisfaction star rating at 8 week follow-up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwestern University Medical Social Sciences city: Chicago state: Illinois zip: 60611 country: United States lat: 41.85003 lon: -87.65005 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-17 uploadDate: 2024-03-17T16:12 filename: Prot_SAP_000.pdf size: 81821 hasResults: False

 nctId: NCT06313723 id: SBÜ-AYDINKARTAL-030 briefTitle: The Effect of Mother's Anxiety, Fear and Prenatal Connection in the Prenatal Education Given to Pregnant Women Via Podcast During the Non-stress Test overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-30 date: 2024-10-31 date: 2024-03-15 date: 2024-03-15 name: YASEMİN AYDIN KARTAL class: OTHER briefSummary: This study was planned to determine the effect of prenatal education given via podcast to nulliparous pregnant women who applied to the Non-Stress Test Polyclinic of the University of Health Sciences, Istanbul Bagcilar Training and Research Hospital, on maternal anxiety, fear and fetal attachment. The research, planned in a randomized controlled quasi-experimental design, will be carried out with nulliparous pregnant women (n:104) who apply to the Non-Stress Test polyclinic of the University of Health Sciences Istanbul Bağcılar Training and Research Hospital. Pregnant women who voluntarily participate in the research will be divided into intervention (n: 52) and control (n: 52) groups according to the computer-assisted simple random sampling technique. The intervention group, nulliparous pregnant women, will listen to 3 podcasts of 5-6 minutes. Pregnant women in the control group will be given a booklet on the pregnancy and birth process from the Ministry of Health as part of routine care. "Personal Information Form", "State-Trait Anxiety Inventory", "Wijma Birth Expectation/Experience Scale Version A" and "Prenatal Attachment Inventory" will be applied to all pregnant women included in the study. conditions: Prenatal Education studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled single-blind quasi-experimental study primaryPurpose: OTHER masking: SINGLE maskingDescription: Single (Participant) Which of the participants is the control or intervention group will be selected by randomization. whoMasked: PARTICIPANT count: 104 type: ESTIMATED name: Prenatal education management delivered via podcast measure: Introductory Information Form measure: State-Trait Anxiety Inventory(D-SKE) measure: Wijma Birth Expectation/Experience Scale Version A (W-DEQ A) measure: Prenatal Attachment Inventory (PBI) measure: State-Trait Anxiety Inventory(D-SKE) measure: Wijma Birth Expectation/Experience Scale Version A (W-DEQ A) measure: Prenatal Attachment Inventory (PBI) sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: University of Health Sciences city: Istanbul zip: 34668 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06313710 id: Y (2024) 058 briefTitle: Head Down Position for Successful Recanalization of Anterior Circulation Large Vessel Occlusion (HOPES4) overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2026-12-01 date: 2026-12-01 date: 2024-03-15 date: 2024-04-19 name: General Hospital of Shenyang Military Region class: OTHER briefSummary: This is a prospective, randomized, open label, blinded-end point, single-center study, aiming to investigate the effect of head down position in anterior circulation large vessel occlusion patients with successful recanalization after endovascular treatment. conditions: Ischemic Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: head down position measure: Changes in National Institute of Health stroke scale (NIHSS) measure: proportion of excellent functional outcome measure: proportion of favorable functional outcome measure: ordinal distribution of modified Rankin Score (mRS) measure: early neurological improvement (ENI) measure: changes in infarct volume measure: changes in cerebral edema measure: Changes in National Institute of Health stroke scale (NIHSS) measure: new stroke or other vascular event(s) measure: proportion of sympomatic intracranial hemorrhage measure: proportion of intraparenchymal hemorrhage (PH) measure: percentage of severe adverse events measure: all-cause mortality measure: changes in dynamic cerebral autoregulation (dCA) measure: changes in cortical oxygen saturation measure: changes in serum biomarkers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Neurology, General Hospital of Northern Theater Command city: Shenyang zip: 110016 country: China name: Hui-Sheng Chen, Ph.D. role: CONTACT phone: +86 13352452086 email: chszh@aliyun.com lat: 41.79222 lon: 123.43278 hasResults: False

 nctId: NCT06313697 id: GR2102-001 briefTitle: A Study to Evaluate the Safety, Immunogenicity, and Pharmacokinetics of GR2102 in Healthy Adult overallStatus: NOT_YET_RECRUITING date: 2024-03-24 date: 2025-01-06 date: 2025-12-06 date: 2024-03-15 date: 2024-03-15 name: Genrix (Shanghai) Biopharmaceutical Co., Ltd. class: INDUSTRY briefSummary: the goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2102 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2102 injection or placebo administration, with each Subjects will be enrolled in only one of these groups。 conditions: Respiratory Syncytial Virus Infections studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 132 type: ESTIMATED name: GR2102 injection name: placebo measure: Adverse events measure: Maximum Observed Serum Concentration measure: Terminal Elimination Half Life measure: anti-respiratory syncytial virus neutralizing antibodies titer levels sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: The First Affiliated Hospital of Shandong First Medical University city: Jinan state: Shandong zip: 250102 country: China name: linlin song, MD role: CONTACT phone: 18853169334 email: qylcsyllwyh@163.com lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06313684 id: Fondecyt 1230787 briefTitle: Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure acronym: COCREATIONHF overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-09 date: 2027-03 date: 2024-03-15 date: 2024-03-26 name: Universidad de La Frontera class: OTHER name: University of Chile briefSummary: CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone. conditions: Heart Failure NYHA Class II conditions: Heart Failure NYHA Class III studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 152 type: ESTIMATED name: Comprehensive Initial Assessment name: Continuous evaluation name: Interval Exercise name: Psychosocial support name: Diet management name: Resistance exercise name: Continuous exercise name: Initial Assessment measure: Cardiorespiratory fitness measure: Functional capacity measure: Health Related Quality of Life measure: Program adherence and completion measure: Concentration of Pro-B-type Natriuretic Peptide measure: Functioning measure: Mortality and Hospital admission measure: Upper-body muscle strength measure: Lower-body muscle strength measure: Cost sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Complejo Hospitalario San José city: Santiago country: Chile name: Manuel Galvez role: CONTACT lat: -33.45694 lon: -70.64827 facility: Hospital Clínico Universidad de Chile city: Santiago country: Chile name: Karen Rouliez role: CONTACT lat: -33.45694 lon: -70.64827 facility: Hospital San Borja Arriarán city: Santiago country: Chile name: Gonzalo Latin role: CONTACT lat: -33.45694 lon: -70.64827 facility: Universidad de La Frontera city: Temuco country: Chile name: Francisca Contreras role: CONTACT lat: -38.73965 lon: -72.59842 hasResults: False

 nctId: NCT06313671 id: Perfusion Index - FR study briefTitle: Plethysmographic Perfusion Index and Fluid Responsiveness acronym: PPI-FR overallStatus: RECRUITING date: 2024-02-10 date: 2024-09 date: 2024-09 date: 2024-03-15 date: 2024-03-15 name: Avicenna Military Hospital class: OTHER briefSummary: The objective of this study is to assess the reliability of the perfusion index to predict fluid responsiveness in patients with acute circulatory failure in intensive care. conditions: Fluid Responsiveness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Perfusion index measure: Reliability and accuracy of the perfusion index to discriminate fluid-responsiveness. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Avicenna Military Hospital status: RECRUITING city: Marrakesh state: Marrakesh Tensift El Haouz zip: 40000 country: Morocco name: Younes Aissaoui, MD role: CONTACT phone: +21266140333 email: younes.aissaoui@live.fr name: Chaimae Abouelkemhe, MD role: CONTACT phone: +212694830675 email: chaimaeabouelkemhe@gmail.com lat: 31.63416 lon: -7.99994 hasResults: False

 nctId: NCT06313658 id: Total BPBI briefTitle: Enhancing Functional Hand Recovery Through Nerve Reconstruction in Total Brachial Plexus Birth Injury overallStatus: RECRUITING date: 2024-03-15 date: 2025-03-15 date: 2025-03-15 date: 2024-03-15 date: 2024-03-15 name: Assiut University class: OTHER briefSummary: Interpreting the published outcomes of hand function in total BPBI is confounded by a lack of clear documentation regarding detailed surgical findings and management strategies. Investigators have followed a well-defined protocol for surgical reconstruction with the primary objective being reinnervation of the lower trunk using the best available root. In this paper, Investigators outline the details of the strategy and provide a comprehensive analysis of the nerve reconstruction techniques and the resulting functional outcomes. conditions: Brachial Plexus Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED name: Total brachial plexus exploration and reconstruction measure: Active Movement Scale (AMS) measure: Al-Qattan pronation/Supination score measure: Raimondi hand score sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Assiut University Hospitals status: RECRUITING city: Assiut zip: 71526 country: Egypt name: Yousif T El-Gammal, MD role: CONTACT phone: 5023797500 email: yousif.elgammal@med.aun.edu.eg lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06313645 id: B83C22004880006 briefTitle: Vascular Senescence and Atherosclerotic Plaque Vulnerability acronym: VICTORIA overallStatus: RECRUITING date: 2023-07-01 date: 2025-07-01 date: 2025-12-31 date: 2024-03-15 date: 2024-03-19 name: Niguarda Hospital class: OTHER name: Istituto di Fisiologia Clinica CNR briefSummary: Chronological aging significantly contributes to structural and functional alterations in the vasculature, making it a major risk factor for atherosclerotic disease and its acute thrombotic events. DNA damage, including telomeric, non-telomeric, and mitochondrial damage, is recognized as a key initiator of vascular aging and atherogenesis. There is abundant evidence indicating the presence of oxidative DNA lesions, telomere erosion, and mitochondrial DNA damage in both experimental and human plaques, as well as in the peripheral cells of atherosclerotic patients.

It is increasingly evident that genomic instability activates signaling pathways that lead to a multitude of pathophysiological cellular and molecular changes. These changes promote inflammation, apoptosis, autophagy, and ultimately, cellular senescence, accompanied by the "senescence-associated secretory phenotype" (SASP). However, the precise mechanisms linking the DNA damage response (DDR) to senescence, SASP in vascular cells, and the pathogenesis of atherosclerosis and vulnerable atheroma are yet to be fully understood. Additional research is needed to delineate the underlying mechanisms through which mitochondrial dysfunction influences telomere length and vice versa, and how their interaction contributes to the vascular aging process. Progress in this area has the potential to uncover therapeutic targets and novel, more precise diagnostic, and prognostic indicators.

The objectives of the VICTORIA study are to examine the levels of aging-related non-coding RNA deregulation (specifically lncRNA TERRA and mitomiR) and peripheral markers of cell aging (including telomere length and mitochondrial DNA content) across the various spectra of angina pectoris (stable angina, unstable angina, NSTEMI, and STEMI). Additionally, the study aims to determine whether these markers are correlated with vulnerable plaque characteristics and major adverse cardiovascular events. conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Several biomarkers measure: Telomere length measure: Mitochondrial DNA copy number (mtDNAcn) measure: MitomiR measure: Long non-coding (lnc) RNA TERRA measure: pro-oxidant cytokines sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASST GOM Niguarda status: RECRUITING city: Milano state: Lombardia zip: 20162 country: Italy name: Jonica Campolo, MSc role: CONTACT phone: +39026444 phoneExt: 5578 email: jonica.campolo@ospedaleniguarda.it name: Emanuela Piccaluga, MD role: CONTACT phone: +39026444 phoneExt: 2308 email: emanuela.piccaluga@ospedaleniguarda.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06313632 id: STUDY-23-01105 briefTitle: Erector Spinae Plane Block With Bupivacaine for Medical Thoracoscopy overallStatus: RECRUITING date: 2024-03-13 date: 2025-03 date: 2025-03 date: 2024-03-15 date: 2024-03-20 name: Icahn School of Medicine at Mount Sinai class: OTHER briefSummary: PlAcebo versus erector spINae pLane block for mEdical ThoracoScopy Study (PAINLESS). This is a prospective triple-blind, randomized controlled trial that evaluates the efficacy of erector spinae plane block (ESPB) with Bupivacaine in reducing pain after medical thoracoscopy (MT) in addition to monitored anesthesia care vs monitored anesthesia care alone. conditions: Pleural Disease conditions: Postoperative Pain studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Triple blind study whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Bupivacaine injection name: Placebo name: Monitored Anesthesia Care measure: Visual Analog Scale (VAS) for Pain measure: Change in the Numerical Rating Scale measure: Type of Analgesic use measure: Number of Analgesic use measure: Dosage of Analgesic use measure: Quality of Recovery-15 (QoR-15) Survey Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mount Sinai West Hospital status: RECRUITING city: New York state: New York zip: 10019 country: United States name: Udit Chaddha, MBBS role: CONTACT phone: 212-824-8546 email: udit.chaddha@mssm.edu name: Udit Chaddha role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06313619 id: BSMMU/20236831 briefTitle: Decreasing Irrational Antimicrobial Use in Bangladesh: A Digital Intervention Program overallStatus: RECRUITING date: 2023-10-23 date: 2024-03-31 date: 2024-03-31 date: 2024-03-15 date: 2024-03-15 name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh class: OTHER briefSummary: The misuse, irrational, or overuse of antibiotics, antibiotic/antimicrobial resistance (AMR) is a global threat to human health. Even though the awareness of the potential threat from AMR is widespread, studies and monitoring programs describing the present situation are lacking. The presence of a 'pluralistic' health system and a large informal sector involving unqualified drug dispenser/providers/practitioners in Bangladesh is a matter of grave concern for the rising antimicrobial resistance situation in the country. An estimated 63% of antibiotic prescriptions are from unqualified providers. Besides, misconception about antibiotics is very common in Bangladesh. Meanwhile, the use of antibiotics in animal food production with insufficient veterinary supervision for therapeutic purposes which poses the risk of antimicrobial resistance transmission in the food chain. Without adherence to national regulations, unnecessary and inappropriate prescriptions become common practice, particularly in rural areas. Domestic drug industries contribute to easily accessible and affordable drugs. To tackle this problem, prescriptions and sales of antibiotics need to be regulated and integrated in a national HMIS. Awareness programs for antibiotic providers that promote understanding of antibiotics and antibiotic resistance through tailored interventions may be helpful in changing current antibiotic sales practices. Therefore, this study will attempt to identify the underlying causes of irrational anti-microbial usage in Bangladesh, which were grouped into four interlinked areas - lack of awareness among patients/ consumers (demand side), perverse incentives and lack of knowledge among providers (supply side), poorly regulated pharmaceutical marketing and retail sales (regulatory side) and lack of data and research evidence to support awareness raising and policymaking (enabler).

A before-after designed quasi experimental study will be conducted in urban areas. Data will be collected in both qualitative and quantitative methods. Multi-cluster sampling method will be used to select study locations. Pharmacists or drug sellers and patients aged more than 18 years and located within selected intervention areas will be our target population. A baseline survey will be conducted among the pharmacy volunteers to evaluate their knowledge, perception, and practice of rational use of anti-microbials prior to any intervention. Additionally, a household survey will be conducted among community members applying systematic random sampling where one adult from every selected household will be approached maintaining gender equality. After collecting the baseline data, intervention will be given to the community people through awareness building campaign and distributing leaflets and posters on rational use of anti-microbials. After three months, a follow-up survey will be conducted among the same participants with the same questionnaire. For quantitative portion of the study, all the medicine shops in the selected study areas will be included in the study sample alongside a total of anticipated 6240 community dwellers. For qualitative part, the sample will be selected purposively until data saturation and a total of 20 experts will be interviewed. Two sets of questionnaires for pharmacy volunteers and the community dwellers will be prepared based on literature review that will include health literacy questions regarding anti-microbial use. The questionnaire for the follow-up data collection will include some additional questions regarding acceptability, adoption, feasibility, and cost of the intervention.

The study is expected to bring light upon a comprehensive understanding of the current level of knowledge, perception and practice of irrational use of anti-microbials among target population. Furthermore, a digital intervention design will be produced to reduce irrational use of anti-microbials after considering its effectiveness. The wide range of the study findings will aid in assessing the acceptability, adoption, feasibility and cost of the intervention to make recommendations on sustainability and scaling up of the intervention programs. conditions: Resistance Bacterial conditions: Increased Drug Resistance conditions: Drug Resistance, Microbial studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 39 type: ESTIMATED name: SmartAMR measure: Irrational usage of anti-microbials measure: Acceptance rate measure: Completion rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medicine Shop status: RECRUITING city: Dhaka zip: 1212 country: Bangladesh name: Abid Hasan Khan, MPH role: CONTACT phone: +8801308634347 email: ahkriaz.ju@gmail.com lat: 23.7104 lon: 90.40744 hasResults: False

 nctId: NCT06313606 id: 2047436 briefTitle: Sparking Gut Bacteria Production of Bioactive Xenolipids in Situ overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-31 date: 2024-05-31 date: 2024-03-15 date: 2024-03-26 name: University of California, Davis class: OTHER briefSummary: Long-chain cyclopropane fatty acids (CpFAs) are microbially-derived lipids (fats), some of which can be found in select foods and appear to be produced naturally in the gut from dietary fatty acid precursors. Some of these lipids appear to have signaling properties in the body's tissues, i.e., to help regulate cardiometabolic health. Thus, increasing the bioavailability of CpFAs in humans may have utility to improve management of blood sugar and blood lipids, or to mitigate or prevent non-alcoholic fatty liver disease (NAFLD). This study is a proof-of-principle experiment in 10 subjects, to feed dietary fats thought to enhance upper gut CpFA production. The latter will be monitored through post-meal blood and urine CpFA concentration measurements, as well as concentration in the stool. conditions: Dietary Fat Metabolism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ESTIMATED name: Dietary fat positive control name: Dietary fat negative control measure: Cyclopropane fatty acid metabolite concentrations in blood, urine, and stool sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of California, Davis School of Medicine city: Sacramento state: California zip: 95817 country: United States name: Sean H. Adams, PhD role: CONTACT phone: 916-734-4868 email: shadams@ucdavis.edu lat: 38.58157 lon: -121.4944 hasResults: False

 nctId: NCT06313593 id: INCB160058-101 briefTitle: A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms overallStatus: NOT_YET_RECRUITING date: 2024-06-14 date: 2027-06-06 date: 2027-09-04 date: 2024-03-15 date: 2024-03-15 name: Incyte Corporation class: INDUSTRY briefSummary: This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms. conditions: Myeloproliferative Neoplasms studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 66 type: ESTIMATED name: INCB160058 measure: Number of participants with Dose Limiting Toxicities (DLTs) measure: Number of participants with Treatment-emergent Adverse Events (TEAEs) measure: Number of participants with TEAEs leading to dose modification or discontinuation measure: INCB160058 pharmacokinetic (PK) in Plasma measure: Response using the revised IWG-MRT and ELN response criteria for MF measure: Percentage of participants achieving spleen volume reduction as defined in the protocol measure: Percentage of participants achieving ≥ 50% reduction from baseline of total symptom score (TSS) measure: Participants with MF with symptomatic anemia: Anemia Response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06313580 id: 22-1055 briefTitle: Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile overallStatus: RECRUITING date: 2023-01-01 date: 2024-12 date: 2025-06 date: 2024-03-15 date: 2024-03-20 name: University of Alabama, Tuscaloosa class: OTHER name: McCormick Science Institute briefSummary: Among food products receiving attention for prebiotic functionality, spices represent a flavorful vehicle for cultivating a healthy gut microbiota. As the required doses of spice-derived polyphenols to elicit prebiotic and systemic metabolic effects are not well-characterized, additional research is warranted. Thus, the investigators propose to use a food-first synbiotic (prebiotic + probiotic) approach to examine alterations in the gut microbiota pre- and post-intervention/placebo and their relationship with systemic cardiometabolic effects mediated by short chain fatty acids (SCFA) and gut-derived metabolites. conditions: Cardiometabolic Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: In a single blind crossover design, participants are randomized to 4 weeks of yogurt intake twice daily with or without added spices with a two-week washout period between study arms. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The study coordinator and participants are unblinded due to the nature of the study design and intervention; however, the PI will remain blinded. whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Yogurt with added Spices name: Yogurt without added Spices measure: Concentration of fecal short chain fatty acids including acetate, proprionate, and butyrate measure: Concentration of serum leptin measure: Concentration of serum ghrelin (pg/mL) measure: Concentration of serum peptide tyrosine tyrosine (PYY) sex: FEMALE minimumAge: 50 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Alabama status: RECRUITING city: Tuscaloosa state: Alabama zip: 35487 country: United States name: Kristi M. Crowe-White, PhD, RD role: CONTACT phone: 205-348-6173 email: kcrowe@ches.ua.edu lat: 33.20984 lon: -87.56917 hasResults: False

 nctId: NCT06313567 id: Meca-GC briefTitle: Metronomic Capecitabine in Stage III Gastric Cancer overallStatus: RECRUITING date: 2024-03-10 date: 2029-03-10 date: 2029-03-10 date: 2024-03-15 date: 2024-03-15 name: Fudan University class: OTHER briefSummary: The purpose of this study is to find out whether treatment with metronomic capecitabine will improve the survival of gastric cancer patients with stage III who had received standard treatment. conditions: Gastric Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 722 type: ESTIMATED name: Metronomic capecitabine name: Observation measure: Disease-free survival measure: Overall survival measure: Side effects sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200000 country: China name: Dazhi Xu, MD,PHD role: CONTACT phone: 021-64175590 email: xudzh@shca.org.cn lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06313554 id: HMPL-012-SH-ICC101 briefTitle: Surufatinib Combined With Toripalimab and HAIC in the Treatment of Inoperable or Metastatic Intrahepatic Cholangiocarcinoma overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2024-05-20 date: 2027-05-20 date: 2024-03-15 date: 2024-03-15 name: Fudan University class: OTHER briefSummary: This study is a single-arm, open-arm, single-center clinical study to explore the efficacy and safety of HAIC in combination with Surufatinib and Toripalimab in patients with inoperable or metastatic intrahepatic cholangiocarcinoma.

The study was divided into three stages: screening period, treatment period and follow-up period. During the treatment period, the tumor status was evaluated by imaging every 6 weeks (±7 days), and the efficacy was changed to every 8 weeks (±7 days) after 12 weeks until the disease progressed (RECIST 1.1) or death (during the treatment of the patient) or toxicity became intolerable. The tumor treatment status and survival status after the disease progression were recorded. Safety outcome measures included AE, changes in laboratory test values, vital signs and electrocardiogram changes. conditions: Intrahepatic Cholangiocarcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 63 type: ESTIMATED name: Surufatinib、Toripalimab、Gemcitabine、Oxaliplatin measure: ORR objective response rate measure: Progression-Free Survival(PFS) measure: OS overall survival measure: DCR disease control rate measure: Adverse events as assessed by NCI CTCAE v5.0 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06313541 id: 2024-Lung-LDRT/SBRT briefTitle: Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2025-06-30 date: 2025-12-31 date: 2024-03-15 date: 2024-03-15 name: Fudan University class: OTHER briefSummary: This study is a multicenter, randomized controlled clinical trial to explore the preliminary efficacy and safety of treatment response adapted hybrid radiotherapy (LDRT and SBRT) in the first-line treatment of immunotherapy combined with chemotherapy for advanced driver-gene negative NSCLC, and to provide new ideas for the comprehensive treatment of advanced NSCLC conditions: NSCLC Stage IV studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 146 type: ESTIMATED name: SBRT or LDRT name: PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy measure: Progression Free Survival measure: Overall Survival measure: Objective response rate measure: Progression free survival 2 measure: Treatment-related adverse event sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06313528 id: 18726 id: J1I-MC-GZBW type: OTHER domain: Eli Lilly and Company briefTitle: A Study to Measure Calorie Consumption and Usage in Participants With Obesity Using LY3437943 overallStatus: RECRUITING date: 2024-03-20 date: 2025-07 date: 2025-07 date: 2024-03-15 date: 2024-04-19 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of the study is to look at the effect of the study drug compared to placebo on calorie intake, energy metabolism, and appetite. The study will last up to 6 months and may include up to 20 visits. conditions: Obesity studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Sponsor-blind whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 74 type: ESTIMATED name: LY3437943 name: Placebo measure: Change from Baseline in Total Calorie Intake at Lunch and Dinner (Combined) measure: Change from Baseline in Sleep Metabolic Rate (SMR) measure: Change from Baseline in SMR measure: Change from Baseline in 24-hour Energy Expenditure (EE) measure: Change from Baseline in 24-hour EE measure: Change from Baseline in Total Calorie Intake at Lunch measure: Change from Baseline in Total Calorie Intake at Dinner measure: Change from Baseline in Fasting Appetite Visual Analog Score (VAS) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: AdventHealth Orlando status: RECRUITING city: Orlando state: Florida zip: 32804 country: United States role: CONTACT phone: 407-303-7100 name: Steven Smith role: PRINCIPAL_INVESTIGATOR lat: 28.53834 lon: -81.37924 facility: Pennington Biomedical Research Center status: RECRUITING city: Baton Rouge state: Louisiana zip: 70808 country: United States role: CONTACT phone: 225-763-3000 name: Eric Ravussin role: PRINCIPAL_INVESTIGATOR lat: 30.45075 lon: -91.15455 facility: Columbia University Medical Center status: RECRUITING city: New York state: New York zip: 10032 country: United States role: CONTACT phone: 212-305-9949 name: Michael Rosenbaum role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06313515 id: STUDY00019529 briefTitle: Transcutaneous Spinal Cord Stimulation Combined With Arm Bike for Cardiovascular Recovery in SCI overallStatus: RECRUITING date: 2024-04-01 date: 2026-02-01 date: 2027-02-01 date: 2024-03-15 date: 2024-03-19 name: University of Washington class: OTHER briefSummary: Spinal cord injury (SCI) can make it hard for the body to self-regulate some of its automatic functions like blood pressure, breathing, and heart rate. This can also make it hard for those living with SCI to exercise or complete their usual daily activities. The goal of this randomized trial is to test combinatory therapy of moderate arm-crank exercise paired with non-invasive transcutaneous spinal cord stimulation (tSCS) for cardiovascular recovery in adults aged 21-65 following chronic motor-complete spinal cord injury (SCI) at or above the thoracic sixth spinal segment (≥T6).

The main questions the study aims to answer are:

* Conduct tSCS mapping to determine the most effective location and stimulation intensity for BP control in individuals with motor-complete SCI ≥ T6.
* Evaluate the effects 8 weeks of targeted tSCS paired with arm-crank exercise compared to sham stimulation with exercise on improving cardiovascular function in individuals with motor-complete SCI ≥T6.
* Evaluate the dosage-response of 8 weeks vs. 16 weeks of targeted tSCS paired with arm-crank exercise on cardiovascular function in individuals with motor-complete SCI ≥T6.
* Explore the mechanisms involved in cardiovascular recovery with long-term tSCS paired with arm-crank exercise.

Participants will:

* Receive either transcutaneous spinal cord stimulation or "sham" spinal cord stimulation while exercising on an arm-crank bicycle in the first 8 weeks.
* Come in for approximately 60 visits over a 6-month period. This includes 2, 8-week periods where the investigators will ask participants to come in 3x per week for spinal cord stimulation and exercise.
* During assessment visits the researchers will perform a variety of exams including a neurologic, cardiovascular, pulmonary, physical, and autonomic exam, and will ask questions about quality of life and functioning.

Researchers will compare those who receive tSCS and do moderate arm-crank exercise to those who receive a sham stimulation and do moderate arm-crank exercise to see if tSCS is effective at improving cardiovascular and autonomic functioning in those with SCI. conditions: Spinal Cord Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized, single-blind, sham-controlled trial with two arms (tSCS paired with arm-crank exercise compared to sham stimulation with exercise). Participants will be randomized into either the intervention or sham stimulation arm. Those in the sham arm only will initially receive sham stimulation, but then cross over to receive the active treatment arm, such that by the end all participants will have been exposed to the tSCS. tSCS participants will not receive sham stimulation. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 16 type: ESTIMATED name: Transcutaneous Spinal Cord Stimulation name: Arm-crank bike exercise name: Sham Stimulation measure: Change in systolic Blood Pressure (BP) from baseline. measure: Change in systolic Blood Pressure during a sit-up test or head-up tilt test. measure: Heart rate variability recorded by electrocardiogram (ECG). measure: Peak oxygen uptake (VO2peak) measure: Autonomic dysfunction following Spinal Cord Injury (ADFSCI) measure measure: International Standards for Neurological Classification of Spinal Cord Injury measure: International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI) measure: Blood Pressure variability measure: Change from baseline- Graded Redefined Assessment of Strength, Sensation, and Prehension version 2 measure: Change from baseline- Capabilities of Upper Extremity Test measure: International Spinal Cord Injury Pain Basic Dataset version 2.0 measure: International Spinal Cord Injury Lower Urinary Tract Function Dataset measure: International Spinal Cord Injury Bowel Function Dataset sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Washington status: RECRUITING city: Seattle state: Washington zip: 98195 country: United States name: Soshi Samejima, DPT, PhD role: CONTACT lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06313502 id: 274271 briefTitle: High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2028-04 date: 2024-03-15 date: 2024-03-15 name: University of Arkansas class: OTHER name: University of Iowa briefSummary: The purpose of this research is to evaluate whether HDAA in combination with a single dose of 100 mg/m2 IV melphalan followed by autologous stem cell transplantation (ASCT) is safe and effective for subjects with relapsed refractory multiple myeloma. The proposed melphalan dose is 50% of the current standard myeloablative dose (200 mg/m2). Based on our preclinical data, the investigator hypothesize that the combination of reduced dose melphalan with IV HDAA will have high efficacy and tolerability

Primary Objective To determine tumor response using International Myeloma Working Group (IMWG) criteria (see Appendix B).

Secondary Objectives

Objectives:

1. Determine the safety and tolerability of HDAA in combination with reduced dose melphalan conditioning and autologous stem cell transplantation (ASCT) in relapsed refractory multiple myeloma subjects.
2. Determine the rate of Minimal Residual Disease (MRD) negativity at time point of response assessment using 8 color flow cytometry on BM sample. Functional imaging, such as positron emission tomography (PET) scan and magnetic resonance imaging (MRI), will also be performed to assess the disease status.
3. Categorize and quantify adverse events compared to historical control.
4. Determine quality of life parameters using standardized health-related quality of life measures
5. Determine oxidative stress parameters in plasma during treatment. conditions: Plasma Cell Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: 75gm HDAA name: 100gm HDAA name: 125gm HDAA measure: Tumor Response measured by IMWG criteria measure: Safety and Tolerability of HDAA with reduced dose melphalan measured using number and severity of AEs measure: Rate of Minimal Residual Disease (MRD) negativity using 8 color flow cytometry measure: Determine quality of life parameter using QLQ-C30 measure: Determine quality of life parameter using EQ-5D-5L sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06313489 id: 282151 briefTitle: Rupture of Thumb's Long Extensor Tendon After Fracture of the Distal Radius, Study of Muscle and Tendon Pathology overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-01 date: 2023-12-31 date: 2024-06-30 date: 2024-03-15 date: 2024-03-15 name: Sahlgrenska University Hospital, Sweden class: OTHER briefSummary: Fractures of the wrist (fractures of the distal radius) are one of the most common fractures with almost 60 000 injuries per year in Sweden. One known complication following these fractures is that the long extensor tendon of the thumb ruptures (extensor pollicis longus tendon, EPL tendon). This leads to disability to stretch the thumb in order to grip bigger objects. Earlier studies show that the tendon ruptures in about 3-5% of all wrist fractures. These ruptures occur some weeks to months after the fracture.

There are different theories about the cause of the rupture. One theory is that the fracture creates a bleeding in the tight area that the tendon lies, leading to high pressure and therefore low blood supply to the tendon. Another theory is that the tendon comes in contact with some sharp bonny fragments in this area that injures the tendon when it moves.

Such tendon ruptures need almost always some type of surgical intervention in order to reconstruct the function of the thumb. A common problem is that the quality of the tendon is insufficient for just suturing it. Another problem is that the muscle becomes stiff after the rupture. However, there is no objective method to determine how stiff the muscle is.

The most common treatment option is the transfer of one of the two extensor tendons of the index finger to the thumb, a so-called extensor indicis proprius to extensor pollicis longus transfer. The motivation behind this operation is that the muscle of EPL is so stiff that cannot be used to lift the thumb. However, there is no consensus about the time period after which the EPL muscle can be used to reconstruct the function of thumb.

The study aims to investigate the microscopical changes in the muscle and tendon of EPL after such a rupture. Better knowledge of these factors could lead to better understanding of the treatment options.

The investigators plan to include in the study all patients that would get operated for an EPL tendon rupture after a fracture of the distal radius at the institution the study is conducted. After oral and written information to the patient and written consent the investigators will take some samples from the ruptured tendon and muscle for microscopical analysis. conditions: Distal Radius Fractures conditions: Tendon Injury - Hand conditions: Pathology studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 13 type: ACTUAL name: Biopsy of EPL tendon and muscle during the operation measure: Histopathological analysis of the EPL muscle measure: Histopathological analysis of the EPL tendon sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sahlgrenska University Hospital city: Gothenburg state: Västra Götaland zip: 43180 country: Sweden lat: 57.70716 lon: 11.96679 hasResults: False

 nctId: NCT06313476 id: SYSKY-2024-030-01 briefTitle: AMH Predicts Postchemotherapy Menopause in Premenopausal Breast Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-04-30 date: 2026-04-30 date: 2024-03-15 date: 2024-03-15 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: To determine the accuracy of AMH postchemotherapy in predicting permanent menopause after chemotherapy in breast cancer patients who did not use OFS before menopause conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 153 type: ESTIMATED measure: Anti-Mullerian Hormone measure: Estradiol measure: Follicle Stimulating Hormone measure: Menstruation sex: FEMALE minimumAge: 40 Years maximumAge: 59 Years stdAges: ADULT hasResults: False

 nctId: NCT06313463 id: SYSKY-2023-1282-02 briefTitle: Study Of Capecitabine Combined With Camrelizumab For Non-pCR TNBC With TLS After Neoadjuvant Chemoterapy overallStatus: RECRUITING date: 2024-03 date: 2031-09 date: 2035-12 date: 2024-03-15 date: 2024-03-15 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: This study aims to evaluate the efficacy and safety of camrelizumab in combination with capecitabine compared to placebo in combination with capecitabine as adjuvant therapy for patients with triple-negative breast cancer (TNBC) who have not achieved pathological complete response (pCR) after neoadjuvant chemotherapy and have tertiary lymphoid structures (TLS) in the tumor tissue. The primary endpoint of this study is disease-free survival (DFS) to assess the long-term effectiveness of the treatment. Secondary endpoints include invasive disease- free survival (IDFS), overall survival (OS), distant recurrence-free interval (DRFI), as well as safety and patient-reported outcomes. These endpoints will comprehensively evaluate the effectiveness of the treatment and the overall survival status of the patients.

The study anticipates a total sample size of 375 patients, who will be randomly assigned to either the experimental group or the control group. The experimental group will receive 8 cycles of adjuvant therapy of capecitabine and camrelizumab. The control group will receive 8 cycles of adjuvant therapy with capecitabine and placebo. This study aims to investigate whether non-pcr breast cancer patients with TLS in tumors can benefit from the adjuvant immunotherapy. conditions: Breast Neoplasms studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 375 type: ESTIMATED name: Carrellizumab + Capecitabine name: Placebo + Capecitabine measure: Disease-Free Survival measure: Invasive Disease-Free Survival measure: Overall Survival measure: Distant Recurrence-Free Interval measure: Patient-reported outcomes-Proportion of patients in each group experiencing clinically meaningful deterioration measure: Patient-reported outcomes-EORTC QLQ-C30 scores after treatment measure: Patient-reported outcomes-EORTC QLQ-C30 scores changes sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510120 country: China name: Shicheng Su, M.D., Ph.D. role: CONTACT phone: +86 13632394954 email: lnl_trial@126.com name: Erwei Song, M.D., Ph.D. role: CONTACT phone: +86 13719237746 email: lnl_trial@126.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06313450 id: B2023-110-X02 briefTitle: De-escalated Radiotherapy for Primary Tumor After Neoadjuvant Therapy With Toripalimab Plus Chemotherapy for Nasopharyngeal Carcinoma overallStatus: RECRUITING date: 2024-03-04 date: 2026-02-01 date: 2028-02-01 date: 2024-03-15 date: 2024-03-19 name: Sun Yat-sen University class: OTHER briefSummary: In the IMRT era, patients with stage II-III (AJCC8th) nasopharyngeal carcinoma achieve high local control. However, survivors are increasingly experiencing late radiation-induced toxicities. A previous study found that reducing the radiation dose to the primary site to 60Gy for patients who achieved partial or complete response to induction chemotherapy resulted in a lower rate of late toxicities and an inferior local control rate. The investigators aim to reduce the radiation dose to the primary site for patients after immunochemotherapy, given the potential of neoadjuvant chemotherapy and immunotherapy to increase response rates and long-term survival. The protocol includes participants with stage II-III (AJCC8th), except T2N0M0, to receive three courses of neoadjuvant gemcitabine plus cisplatin and Toripalimab. If the primary tumour regresses by over 75%, de-escalated radiotherapy with 60Gy will be administered, and participants will receive two cycles of cisplatin and three cycles of Toripalimab during the radiotherapy course. Otherwise, participants will receive conventional radiotherapy and concurrent chemotherapy with cisplatin for two cycles as usual. The aim of this study is to investigate the 3-year local control rate and toxicities of de-escalated radiotherapy. conditions: Nasopharyngeal Carcinoma conditions: Radiotherapy; Complications conditions: IMMUNOTHERAPY studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 112 type: ESTIMATED name: de-escalated radiotherapy name: conventional radiotherapy measure: local recurrence rate(LRR) measure: primary tumor volume regression≥75% rate measure: 3-year overall survival measure: acute and late radiation-induced toxicities measure: complete response rate of primary tumor sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen University Cancer Center status: RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Puyun Ouyang role: CONTACT phone: +8602087342926 email: ouyangpy@sysucc.org.cn name: Fangyun Xie role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06313437 id: 24-021 briefTitle: Revumenib in Combination With 7+3 + Midostaurin in AML overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-03-02 date: 2027-03-02 date: 2024-03-15 date: 2024-03-21 name: Maximilian Stahl, MD class: OTHER name: Syndax Pharmaceuticals briefSummary: This research is being conducted to determine a safe and effective dose of revumenib that can be given in combination with standard induction (initial therapy to induce a remission) + FLT3 targeted therapy (midostaurin) and a single cycle of post-remission therapy + FLT3 targeted therapy (midostaurin) to participants with newly diagnosed Nucleophosmin (NPM1) and FMS-like tyrosine kinase 3 (FLT3) mutated Acute Myeloid Leukemia (AML).

The names of the study drugs involved in this study are:

* Revumenib (SNDX-5613) (a type of menin inhibitor)
* Midostaurin (a type of multi-kinase including FLT3 inhibitor)
* Cytarabine (a type of antineoplastic agent)
* Daunorubicin (a type of antineoplastic agent) conditions: Acute Myeloid Leukemia conditions: AML, Adult conditions: AML With Gene Mutations conditions: AML conditions: Leukemia studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: Revumenib name: Midostaurin name: Cytarabine name: Daunorubicin measure: Number of Participants Experiencing Dose Limiting Toxicity (DLT) measure: Maximum Tolerated Dose (MTD) measure: Recommended phase II dose (RP2D) measure: Complete Remission (CR) rate with induction chemotherapy measure: Complete Remission (CR) rate with consolidation chemotherapy measure: Flow Measurable Residual Disease Negative (MRD-) rate with induction chemotherapy measure: Flow Measurable Residual Disease Negative (MRD-) rate with consolidation chemotherapy measure: Molecular Measurable Residual Disease Negative (MRD-) rate with induction chemotherapy measure: Molecular Measurable Residual Disease Negative (MRD-) rate with consolidation chemotherapy measure: Relapse-Free Survival at 1 year (RFS1) measure: Overall Survival at 1 year (OS1) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02215 country: United States lat: 42.35843 lon: -71.05977 facility: Dana-Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06313424 id: 9029 briefTitle: Arthroscopic Treatment of Meniscal Lesions on Healthy Meniscus in Children and Adolescents acronym: ATML overallStatus: RECRUITING date: 2023-08-29 date: 2024-04 date: 2024-04-29 date: 2024-03-15 date: 2024-03-15 name: University Hospital, Strasbourg, France class: OTHER briefSummary: Meniscal lesions are common in pediatrics and mainly affect adolescents. These lesions can jeopardize the functional prognosis of the knee in the short, medium or long term if they are not well managed.

More precisely, it is a question of determining whether arthroscopic repair of isolated meniscal lesions in children gives good results and what factors influence them, with the aim of improving the care of children suffering from meniscal lesions.

The treatment of meniscal lesions comes down to either conservative or restorative treatment or non-conservative treatment by meniscectomy. For most authors, the treatment of meniscal lesions must remain restorative through meniscal suture, leaving no room for meniscectomy. The open approach has given way to the arthroscopic approach which, according to the literature, is the gold standard. Meniscal lesions are varied and therefore there are numerous therapeutic procedures. Therapeutic indications are precise but the results of the treatments remain differently assessed depending on the studies; studies evaluating the results of treatment in the pediatric population are few in number.

Based on this observation, the present study aims to describe the results of repairs of meniscal lesions in pediatric traumatology. conditions: Knee Injuries studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 120 type: ESTIMATED measure: description of the results of repairs of meniscal lesions in pediatric traumatology sex: ALL minimumAge: 1 Year maximumAge: 17 Years stdAges: CHILD facility: Service de Chirurgie Pédiatrique - CHU de Strasbourg - France status: RECRUITING city: Strasbourg zip: 67091 country: France name: Philippe GICQUEL, MD, PhD role: CONTACT phone: 33 3 88 12 82 65 email: Philippe.Gicquel@chru-strasbourg.fr name: Philippe GICQUEL, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Saïd Nahl Oumar GANAME, MD role: PRINCIPAL_INVESTIGATOR lat: 48.58392 lon: 7.74553 hasResults: False

 nctId: NCT06313411 id: 8778 briefTitle: How do I Perform a Laparoscopic Removal of a Pelvic Retroperitoneal Schwannoma acronym: PRS overallStatus: RECRUITING date: 2022-11-23 date: 2024-04 date: 2024-04 date: 2024-03-15 date: 2024-03-15 name: University Hospital, Strasbourg, France class: OTHER briefSummary: Schwannomas are mainly benign tumors, which develop mainly in the skull or in the cervical region. Retroperitoneal location is rare, since it represents between 0.5 and 5% of scwhanomas. The malignant retroperitoneal form is, however, more common than in other locations.

Retroperitoneal schwannoma is often discovered during the exploration of unexplained lumbo-pelvic pain, or in the face of compression of nearby organs. Abdominopelvic CT and magnetic resonance imaging are essential to characterize the mass and verify its extension. The precise diagnosis is based on the pathological examination of the part, and complete surgical excision is the standard treatment.

Acquiring the surgical techniques and skills necessary to carry out these types of procedures is essential to providing optimal patient care. conditions: Endometriosis Pelvic studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 1 type: ESTIMATED measure: laparoscopic removal of a retroperitoneal pelvic schwannoma sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Service de Gynécologie Obstétrique - CHU de Strasbourg - France status: RECRUITING city: Strasbourg zip: 67091 country: France name: Emilie FALLER, MD role: CONTACT phone: 33 3 88 12 63 87 email: emilie.faller@chru-strasbourg.fr name: Alexandre PIFFER, MD role: CONTACT phone: 33 6 71 47 38 61 email: Alexandre.piffer@yahoo.fr name: Emilie FALLER, MD role: PRINCIPAL_INVESTIGATOR name: Alexandre PIFFER, MD role: SUB_INVESTIGATOR lat: 48.58392 lon: 7.74553 hasResults: False

 nctId: NCT06313398 id: 10001883 id: 001883-H briefTitle: Determination of Red Cell Survival in Sickle Cell Disease and Other Hemoglobinopathies Using Biotin Labeling overallStatus: RECRUITING date: 2024-05-01 date: 2029-05-01 date: 2029-06-15 date: 2024-03-15 date: 2024-04-26 name: National Heart, Lung, and Blood Institute (NHLBI) class: NIH name: Children's National Research Institute briefSummary: Background:

Sickle cell disease (SCD) is an inherited disorder of the blood. SCD causes red blood cells (RBCs) to die early. This can lead to a shortage of healthy cells. SCD and other blood disorders can be managed with drugs or cured with a bone marrow transplant. Researchers want to know how long RBCs survive in people with SCD and other blood disorders before and after treatment compared to those who had a bone marrow transplant.

Objective:

To learn how long RBCs survive in the body in people with SCD and other blood disorders compared to those whose disease was cured with a bone marrow transplant.

Eligibility:

People aged 18 years or older with SCD or another inherited blood disorder. People whose SCD or blood disorder was cured with a bone marrow transplant are also needed.

Design:

Participants will be screened. They will have a physical exam with blood and urine tests.

Participants will have about 7 tablespoons of blood drawn. In the lab, this blood will be mixed with a vitamin called biotin. Biotin sticks to the outside of RBCs. This process is called "biotin labeling of RBCs." The next day, the participant s own biotin-labeled RBCs will be returned to their bloodstream.

Participants will return regularly to have smaller blood samples (about 2 teaspoons) drawn. These samples will be tested to detect the percentage of cells that have biotin labels. These visits may be every 2 weeks, 4 weeks, or some other interval. Participants will continue this schedule for up to 20 weeks or until biotin can no longer be detected.... conditions: Sickle Cell Disease conditions: Thalassemia conditions: Hemoglobinopathy studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 100 type: ESTIMATED name: Biotin-labeled red blood cells measure: To determine and compare red blood cell survival, by virtue of the mean number of days of detectable biotin-labeled RBCs, in participants with SCD and/or other hemoglobinopathies. measure: Validate the association of RBC survival with known markers of increased survival. sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institutes of Health Clinical Center status: RECRUITING city: Bethesda state: Maryland zip: 20892 country: United States name: NIH Clinical Center Office of Patient Recruitment (OPR) role: CONTACT phone: 800-411-1222 phoneExt: TTY dial 711 email: ccopr@nih.gov lat: 38.98067 lon: -77.10026 hasResults: False

 nctId: NCT06313385 id: 22-10-1180 briefTitle: Investigating the Impact of Indocyanine Green Titration on Fluorescent Intensity in Free Flap : An Exploration of Alternative Indicators overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-01 date: 2024-03-29 date: 2024-03-29 date: 2024-03-15 date: 2024-03-15 name: Indonesia University class: OTHER briefSummary: This study is a randomized clinical trials that aim to determine the effect of Indocyanine Green (ICG) titration dose on the intensity degree of ICG fluorescence imaging results. In addition, this study will also determine the relationship of other indicators such as flap surface temperature, transcutaneous pressure of carbon dioxide (TcPCO2), transcutaneous pressure of oxygen (TcPCO2), HIF - 1 alpha expression, and flap histopathology morphology to the intensity degree of ICG fluorescence imaging results with titrated doses. conditions: Free Flap conditions: Indocyanine Green conditions: Microsurgery conditions: Temperature Change, Body studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The population were divided into three equal groups of indocyanine green concentration : 5 milligram per milliliter (mg/mL), 2,5 mg/mL, and 0,5 mg/mL primaryPurpose: DIAGNOSTIC masking: QUADRUPLE maskingDescription: The participants didn't know about indocyanine green (ICG) drug groups as well as the concentration that they received. The ICG was added into the syringe by research assistant without any label near the end of operation time. The ICG injection to the patient was performed by anesthesiologist who didn't know about the concentration at all. Outcome assessor didn't know about the given concentration. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 63 type: ESTIMATED name: Indocyanine Green Fluorescence (ICG) name: Temperature name: Transcutaneous oxygen and carbon dioxide pressure name: Histopathology name: Hypoxia inducible factor-1 (HIF-1) alpha measure: The Effect of Indocyanine Green Fluorescence Intensity to evaluate free flap perfusion measure: The ICG fluorescence intensity in different titration dose with flap surface Temperature measure: Correlation between ICG fluorescence intensity in different titration dose with transcutaneous carbon dioxide and oxygen pressure measure: Correlation between ICG fluorescence intensity concentration in different titration dose with flap neutrophile count measure: Correlation between ICG fluorescence intensity concentration in different titration dose with flap necrosis volume measure: Correlation between ICG fluorescence intensity concentration in different titration dose with vascular flap proliferation of the tissue measure: Correlation between ICG fluorescence intensity in different titration dose with HIF-1 Alpha sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Cipto Mangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia city: Jakarta Pusat state: Jakarta zip: 10430 country: Indonesia lat: -6.1818 lon: 106.8223 hasResults: False

 nctId: NCT06313372 id: CA2085 briefTitle: Interpreting Respiratory Oscillometry in Adult Asthma and COPD: a Delphi Study overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-11 date: 2025-01 date: 2024-03-15 date: 2024-03-18 name: Scius Healthcare Solutions Pty Ltd class: INDUSTRY name: Chiesi Australia briefSummary: This is an international Delphi study to consolidate expert consensus on the use of respiratory oscillometry in the management of adult patients with asthma or chronic obstructive pulmonary disease (COPD).

The primary objective of the Delphi study is to aid the interpretation of respiratory oscillometry in clinical practice amongst adult patients with asthma or COPD. This will be achieved by obtaining expert consensus on:

* Which parameters are used in clinical practice for impulse oscillometry (IOS) and for forced oscillation technique (FOT) devices.
* What cut-offs can be used for each parameter to guide clinical practice in the management of adult patients with asthma and COPD.

This study is based on the Delphi methodology. The Delphi study will comprise of four rounds, one brainstorming round, to formulate the consensus survey, and three rounds to attempt to obtain consensus.

In each round a questionnaire comprising of statements and questions regarding respiratory oscillometry will be sent to participants in the Delphi study electronically using SurveyLet, an online survey platform. Participants will respond anonymously to the survey questions, indicating their level of agreement or disagreement with each statement or question. Participants will be given 4 weeks to complete each round of the Delphi study.

Questions and statements will be repeated in subsequent rounds until the predefined level of consensus is met or the maximum number of rounds is achieved (limited to a maximum of 3 rounds). Aggregated results for each statement or question, including distribution of results and consensus status, will be provided to participants after each round to facilitate informed decisions in subsequent rounds. conditions: Asthma conditions: Chronic Obstructive Pulmonary Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 50 type: ESTIMATED name: Respiratory oscillometry measure: Identification of which respiratory oscillometry parameters (resistance, [R5, R20, R5-R20], reactance [X5, delta X5] or reactance area [AX]) are used to guide clinical management of asthma or COPD as determined by expert consensus using a ranking scale. measure: Identification of cut-off values used for respiratory oscillometry parameters (R5, X5, AX, R5-R20) to define an abnormal test result as determined by expert consensus using a 6-point categorical scale (Agree strongly to Disagree strongly) measure: Identification of cut-off values used for respiratory oscillometry parameters (R5, X5, and AX) to define a bronchodilator response as determined by expert consensus using a 6-point categorical scale (Agree strongly to Disagree strongly) measure: Identification of cut-off values used for oscillometry parameters (R5, X5, AX, R5-R20) to define a significant clinical change between visits as determined by expert consensus using a 6-point categorical scale (Agree strongly to Disagree strongly) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06313359 id: FY2024-125 briefTitle: Fall Risk and Quality of Life: in Individuals With Cancer Treatment Related Peripheral Neuropathy. overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2025-03-30 date: 2025-06 date: 2024-03-15 date: 2024-03-15 name: Texas Woman's University class: OTHER briefSummary: The purpose of this research is to examine the impact of peripheral neuropathy on fall risk and quality of life in people who had cancer. Specifically, we are interested to find out if you have any difficulty with thinking, feeling, balancing, or moving around that will contribute to risk for falls or quality of life. We are also interested to see if you have any difficulty with doing two activities at the same time, such as walking and texting. conditions: Peripheral Neuropathy Due to Chemotherapy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED measure: Fall risk measure: Quality of life- in cancer patients measure: Trail Making Test (TMT) Parts A & B measure: Single Task- Working Memory measure: Single Task- Visual Attention Cognitive Task measure: Protective Sensation measure: Grip Strength measure: LE strength assessment- HHD measure: Dynamic Balance measure: Single Task- Gait Speed measure: Dual Task- Working Memory & Gait Speed - Composite measure measure: Dual Task- Visual Attention Cognitive Task & Gait Speed - Composite measure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06313346 id: 2023.200 briefTitle: Effect of a Probiotic on Microbiota Associated With the Immune System and Inflammation. acronym: FLORABIOTIC overallStatus: RECRUITING date: 2024-01-08 date: 2024-04-30 date: 2024-06-15 date: 2024-03-15 date: 2024-03-15 name: Clinica Universidad de Navarra, Universidad de Navarra class: OTHER briefSummary: The goal of this randomized clinical trial is to learn about the effect of consuming a probiotic on the microbiota associated with immune health and inflammation in healthy women and men after 6 weeks of intervention.

The main questions to answer are:

1. To study changes in the intestinal microbiota associated with immune health and inflammation related to probiotic intake.
2. To evaluate changes in salivary cortisol after ingestion of the probiotic.
3. To compile the number and intensity of catarrhal episodes suffered by the participants along the study.

For this purpose, a randomized, double blind parallel study has been designed.

Target sample size is 60 subjects.

Participants will be allocated in two groups for 6 weeks:

* Experimental group (n=30): daily consumption of one probiotic capsule.
* Placebo group (n=30): daily consumption of one placebo capsule. conditions: Probiotic conditions: Microbiota studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised, double blinded, parallel intervention primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: The products (experimental and placebo), will be produced by an external producer, who will save the codes. None of the researchers involved in the study development or analyses will know the association until the end of the study. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Probiotic name: Placebo measure: Fecal microbiota measure: Salivary cortisol measure: Body weight measure: Height measure: Body mass index measure: Body fat percentage measure: Body muscle mass measure: Body lean mass measure: Body water mass measure: Body bone mass measure: The incidence of catarrhal episodes measure: The gravity of catarrhal episodes measure: Gastrointestinal symptoms measure: Dietary intake measure: Physical activity measure: Adherence to capsule consumption sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre for Nutrition Research status: RECRUITING city: Pamplona state: Navarre zip: 31008 country: Spain name: Fermin Milagro, PhD role: CONTACT phone: 948425600 phoneExt: 806553 email: fmilagro@unav.es lat: 42.81687 lon: -1.64323 hasResults: False

 nctId: NCT06313333 id: SID01 briefTitle: National Register of Moderate and Severe Adult Atopic Dermatitis acronym: ATOPYREG overallStatus: RECRUITING date: 2020-06-15 date: 2024-12-31 date: 2030-06-15 date: 2024-03-15 date: 2024-03-15 name: Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse class: OTHER briefSummary: Collect clinical history and treatment data of AD in adulthood; conditions: Atopic Dermatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1500 type: ESTIMATED measure: Epidemiological data measure: Identification of factors for specific treatment measure: clinical and therapeutic data measure: characterization of diagnostic criteria measure: Assessment of possible conditioning factors sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASST Spedali Civili di Brescia status: RECRUITING city: Brescia zip: 25123 country: Italy name: Piergiacomo MD Calzavara Pinton role: CONTACT phone: 0303995305 email: piergiacomo.calzavarapinton@unibs.it lat: 45.53558 lon: 10.21472 hasResults: False

 nctId: NCT06313320 id: OAIC1344-23 briefTitle: Intraoperative Electroencephalographic Biomarkers of Postoperative Pain overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-06 date: 2024-03-15 date: 2024-03-15 name: University of Chile class: OTHER briefSummary: The goal of this study is to explore whether specific intraoperative EEG signals (brain waves or neuronal electrical activity) are associated with the severity of acute postoperative pain. conditions: Pain Postoperative conditions: Nociceptive Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED measure: Maximum Pain in PACU measure: Opioid Consumption in PACU measure: Maximum Pain at 24h measure: Presence of surgical related pain at day 7 measure: Presence of surgical related pain at day 30 sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hospital Clinico de la Universidad de Chile city: Santiago state: RM zip: 7563215 country: Chile name: Rodrigo Gutierrez, MD, PhD role: CONTACT phone: +56995993665 email: rodrgutierrez@uchile.cl lat: -33.45694 lon: -70.64827 facility: Centro de Investigacion Clinica Avanzada city: Santiago country: Chile lat: -33.45694 lon: -70.64827 hasResults: False

 nctId: NCT06313307 id: famotidine and melasma briefTitle: The Efficacy in Treatment of Facial Melasma Combined With Thulium 1927-nm Fractional Laser and Topical H2R Antagonist overallStatus: COMPLETED date: 2023-04-01 date: 2023-11-25 date: 2023-11-25 date: 2024-03-15 date: 2024-03-15 name: Second Affiliated Hospital of Xi'an Jiaotong University class: OTHER briefSummary: Melasma is a hyperpigmentary disorder of the skin especially of the face. Compared with normal skin, histologic features of melasma include the enhanced activity of melanocytes, higher solar elastosis in upper dermis, basement membrane disruption which promotes melanocytes and melanin into the dermis, increased vascularization, and an increased number of mast cells.

1927nm fractional laser was approved to treat melasma with no major side effects, however,hyperpigmentation and recurrence occasionally happened after laser therapy. Mast cells may paly a key role in the refractory melasma and hyperpigmentation. We hypothesized that laser treatment may stimulate the activation of pre-existing mast cell in melasma skin and promote mast cell proliferation and degranulation to release mediators such as histamine (HA). HA has been demonstrated to increase the melanin content and tyrosinase activity of melanocytes and induce melanogenesis and morphological changes by activating cAMP-PKA pathway through H2 receptors on melanocytes5. H2R antagonist(H2RA) can suppress pigmentation by reducing the increase of activated melanocytes by UVB irradiation.

In the present study, the investigators speculated that H2RA can enhance the efficacy of laser treatment of melasma and block the histamine-mediated melanogenesis and dendricity to prevent postoperative hyperpigmentation. The investigators combined 1927nm fractional laser with topical famotidine for melasma as a new therapeutic strategy to treat melasma.The investigators performed a split-face, single-blinded study to evaluate the efficacy and safety of 1927nm fractional laser with topical famotidine for the treatment of facial melasma. conditions: Melasma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 16 type: ACTUAL name: topical H2R antagonist name: Thulium 1927-nm Fractional Laser measure: Modified Melasma Area Severity Score（mMASI） measure: melanin index（MI） measure: erythema index(EI) measure: Melasma Quality of Life Index(MELASQoL) sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: The second affiliated hospital of Xi'an Jiaotong University city: Xi'an state: Shaanxi zip: 710000 country: China lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06313294 id: 230929002 briefTitle: Postoperative Follow-up Via Text Messages Automated Versus Telephone in Patients With Continuous Regional Anesthesia acronym: txt-RA overallStatus: NOT_YET_RECRUITING date: 2024-04-04 date: 2024-09-30 date: 2024-12-31 date: 2024-03-15 date: 2024-03-29 name: Pontificia Universidad Catolica de Chile class: OTHER briefSummary: Monitoring performed by a trained operator has proven to be useful and valued by patients after the use of continuous regional anesthesia. A health professional calls each patient to gather information about their recovery. However, this direct communication strategy requires time and resources, especially if many patients are involved.

A modern and convenient approach involves the use of immediate communication technology for follow-up after a procedure. They may contain specific questions that patients can easily answer from their mobile devices.

Automated text messages could be associated with greater convenience and ease for patients with response rates at least like the traditional method. Phone calls, on the other hand, may be less scalable and require more human resources.

The objective of the project is to evaluate the feasibility of monitoring through automated electronic messaging by evaluating its usability using a validated scale in Spanish. response rate on the first day and adherence rate compared to that of the traditional method. Secondarily, adherence and differences in satisfaction will be compared. conditions: Anesthesia conditions: Regional Anesthesia conditions: Nerve Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will are assigned to one of two groups in parallel for the duration of the study primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: The research patients will be blind to the proposed intervention. whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Tracking application app name: Telephone interview measure: Usability level of the tracking application measure: Patient satisfaction with Perception of Quality in Anesthesia measure: Patient adherence sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pontificia Universidad Catolica de Chile city: Santiago state: Metropolitana zip: 450881 country: Chile name: Victor Contreras, MSN role: CONTACT phone: 223549217 email: vecontre@uc.cl name: Erick Strange, MD role: PRINCIPAL_INVESTIGATOR lat: -33.45694 lon: -70.64827 hasResults: False

 nctId: NCT06313281 id: E-18-3331 briefTitle: Effectiveness of Preoperative Antiseptic Preparation in Transnasal Skull Base Surgery overallStatus: COMPLETED date: 2019-02-01 date: 2021-09-30 date: 2021-09-30 date: 2024-03-15 date: 2024-03-20 name: King Saud University class: OTHER briefSummary: Objective: Transnasal skull-base surgery is a complex and invasive procedure that involves the use of preoperative antiseptic preparations. However, evidence supporting their use in preventing postoperative infectious complications is limited. The aim of this study is to assess the efficacy of preoperative antiseptic techniques in reducing postoperative infectious complications within 30 days of surgery.

Methods: A multicenter, prospective, randomized, single-blind, three-arm trial was conducted from February 2019 to October 2021. Participants were randomized to either of three antiseptic preparation techniques: external 0.9%NaCl nasal preparation, external 0.05% chlorhexidine gluconate, or intranasal irrigation with 80 mg of gentamicin added to 1000 ml of 0.9%NaCl plus external nasal preparation with chlorhexidine gluconate 0.05%. A total of 130 adults with skull-base pathologies were randomized, 12 were excluded before randomization for failure to meet inclusion criteria (n=9) or refusal to participate (n=3). The investigators excluded patients with evidence of infection adjacent to the surgical site, allergies to preparation methods, those who underwent craniotomy during the same admission, and pediatric patients. conditions: Meningitis and Sinusitis in Transnasal Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 142 type: ACTUAL name: Preoperative Antiseptic preparation prior to transnasal skull base surgery measure: the difference in the incidence of postoperative infections within 30 days of surgery between the three interventional groups sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: King Saud University city: Riyadh zip: 12394 country: Saudi Arabia lat: 24.68773 lon: 46.72185 hasResults: False

 nctId: NCT06313268 id: LT-02-20 briefTitle: Safety of Effivia®, a Bevacizumab Biosimilar overallStatus: RECRUITING date: 2022-04-21 date: 2024-02-20 date: 2024-06-30 date: 2024-03-15 date: 2024-03-15 name: Laboratorios Liomont class: INDUSTRY name: Servicios Especializados en Ensayos Clínicos, S.C. briefSummary: This is a post-marketing observational study aimed to evaluated the safety profile of Effivia®, a biosimilar of bevacizumab, in mexican patients with different types of cancer. conditions: Metastatic Colorectal Cancer conditions: Metastatic Cervical Cancer conditions: Non Squamous Non Small Cell Lung Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 95 type: ESTIMATED name: Bevacizumab Biosimilar MB02 measure: Adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UMAE Hospital de Especialidades No. 1 status: RECRUITING city: León state: Guanajuato zip: 37320 country: Mexico name: David Suárez García, M.D. role: CONTACT phone: +524777174000 name: David Suárez García, M.D. role: PRINCIPAL_INVESTIGATOR lat: 21.12908 lon: -101.67374 facility: Hospital de Gineco-Obstetricia No. 3 status: RECRUITING city: Azcapotzalco state: Mexico City zip: 02990 country: Mexico name: Eliseo Neftalí de la Cruz Escobar, M.D. role: CONTACT phone: +525557821088 name: Eliseo Neftalí de la Cruz Escobar, M.D. role: PRINCIPAL_INVESTIGATOR lat: 19.48698 lon: -99.18594 facility: Hospital de Oncología, UMAE Centro Médico Nacional Siglo XXI status: RECRUITING city: Cuauhtémoc state: Mexico City zip: 06720 country: Mexico name: Alberto Alfonso Pimentel Rentería, M.D. role: CONTACT phone: +525556276900 name: Alberto Alfonso Pimentel Rentería, M.D. role: PRINCIPAL_INVESTIGATOR lat: 19.44506 lon: -99.14612 facility: Instituto Nacional de Cancerología status: RECRUITING city: Tlalpan state: Mexico City zip: 14080 country: Mexico name: David Francisco Cantú de León, M.D., Ph.D. role: CONTACT phone: +525556280400 name: David Francisco Cantú de León, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 19.29513 lon: -99.16206 facility: Hospital de Oncología IMSS Puebla status: RECRUITING city: Puebla zip: 07200 country: Mexico name: José Gustavo Núñez Cerrillo, M.D. role: CONTACT phone: +522222230690 name: José Gustavo Núñez Cerrillo, M.D. role: PRINCIPAL_INVESTIGATOR lat: 19.03793 lon: -98.20346 hasResults: False

 nctId: NCT06313255 id: KYLL-202301-008-1 briefTitle: A Retrospective Observational Study on the Effects of Prebiotics on HBsAg Clearance overallStatus: RECRUITING date: 2023-05-09 date: 2025-12-31 date: 2025-12-31 date: 2024-03-15 date: 2024-03-15 name: Qilu Hospital of Shandong University class: OTHER briefSummary: The goal of this retrospective observational study is to find out the effects of prebiotics on HBV clearance. The main question it aims to answer is:

Are the prebiotics have an effect in promoting HBV clearance? The participants will observe the HBV clearance rate in chronic hepatitis B patients receive prebiotics in addition to the routine antiviral therapy.

Researchers will compare the HBV clearance rate in chronic hepatitis B patients receive prebiotics and antiviral therapy with those receiving solely antiviral therapy. conditions: Chronic Hepatitis B studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 40 type: ESTIMATED name: PegIFNα2b name: PegIFNα2b+prebiotics name: Nucleoside analog name: Nucleoside analog+prebiotics measure: HBsAg clearance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Qilu Hospital of Shandong University status: RECRUITING city: Jinan state: Shandong zip: 250012 country: China name: Yu-Chen Fan role: CONTACT phone: 0086+053182169596 email: fanyuchen@sdu.edu.cn name: Yu-Chen Fan role: PRINCIPAL_INVESTIGATOR lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06313242 id: 202403 briefTitle: Different Bowel Preparations in Magnetically Controlled Capsule Endoscopy overallStatus: RECRUITING date: 2024-03-14 date: 2025-02 date: 2025-06 date: 2024-03-15 date: 2024-03-19 name: Qilu Hospital of Shandong University class: OTHER briefSummary: The study aimed to compare the effects of bowel preparation methods of a normal diet for 1 day, a low residue diet for 1 day, and laxative bowel cleaning on the image quality of magnetically controlled capsule endoscopy, and to assess the rate of completion of the examination, small intestine transit time, lesion detection, patient tolerance, and safety of the three regimens. conditions: Magnetically Controlled Capsule Endoscopy conditions: Bowel Preparation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 375 type: ESTIMATED name: Polyethylene Glycol Electrolytes Powder (II) name: Low residue diet name: Normal diet measure: Image quality of small intestine measure: Rate of completion of inspections measure: Small intestine transit time measure: Lesion detection rate measure: Patient tolerance measure: Rate of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Qilu Hospital of Shandong University status: RECRUITING city: Jinan country: China name: Feixue Chen role: CONTACT phone: +8618560086108 email: chenfeixue@email.sdu.edu.cn lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06313229 id: KFSIRB200-195 briefTitle: Simultaneous Implant Placement With Vertical and Horizontal Bone Augmentation overallStatus: RECRUITING date: 2024-03-13 date: 2025-03-25 date: 2025-03-31 date: 2024-03-15 date: 2024-04-16 name: Kafrelsheikh University class: OTHER briefSummary: The purpose of this study was to report the clinical and radiographical outcomes of using autogenous cortical bone plates combined with sticky allogenic bone graft for augmenting maxillary anterior atrophic combined horizontal and vertical ridge defects with simultaneous versus staged implant placement. conditions: Alveolar Bone Loss conditions: Dental Implant Failed studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: single-center, prospective, single-blinded, randomized parallel two-arm controlled clinical trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The present clinical trial was single-blinded one as the evaluator and the statistician were both blinded. While both the implantologist or the participant were not blinded as the interventions were dissimilar. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: implant placement 6 months after ridge augmentation name: implant placement Simultaneously with ridge augmentation measure: Stability Quotient of Implants (SQI) measure: Horizontal bone dimensions (HBDs) measure: Peri-implant Bone Density (PBD) sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: faculty of dentistry, kafrelsheikh University status: RECRUITING city: Kafr Ash Shaykh state: Kafrelsheikh zip: 214312 country: Egypt name: Walid elamrousy, PhD role: CONTACT phone: +201091444946 email: perioking1@gmail.com name: Dalia Rasheed Issa, PhD role: CONTACT email: dalia_rasheed@hotmail.com lat: 31.11174 lon: 30.93991 hasResults: False

 nctId: NCT06313216 id: KFSIRB200-187 briefTitle: Treatment of Peri-implant Bone Dehiscence Using Autogenous Tooth Plate overallStatus: RECRUITING date: 2024-03-15 date: 2025-03-30 date: 2025-04-15 date: 2024-03-15 date: 2024-04-09 name: Kafrelsheikh University class: OTHER briefSummary: The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous demineralized tooth graft. with autogenous demineralized tooth plate and compared this approach to autogenous demineralized tooth graft.

The present study included 63 patients, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation with Duo-Teck membrane, while group II patients underwent the same procedure, but the dehisced bone defect was grafted by autogenous demineralized tooth graft. finally group III was grafted by combination of autogenous demineralized tooth graft. with autogenous demineralized tooth plate. conditions: Implant Complication conditions: Peri-Implantitis conditions: Periodontal Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The present study included 63 participants, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation with duoteck membrane, while group II was grafted by autogenous demineralized tooth graft, but group III was grafted with autogenous demineralized tooth graft with autogenous demineralized tooth plate Clinically, pink aesthetic score (PES), midfacial mucosal alterations (MFMA), stability quotient of dental implants (SQDI) were observed at baseline, six and twelve months after implantation. Moreover, baseline, 6- and 12-months alterations of radiographic horizontal buccolingual ridge width (HBLRW), facial marginal bone level (FMBL), peri-implant Density of bone (PIDB) and peri-implant vertical bone defect depth (PIVBDD) changes were assessed using cone beam computed tomography (CBCT). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: neither participant nor the outcome assessor know the group distribution whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 63 type: ESTIMATED name: duoteck membrane name: autogenous demineralized tooth graft name: autogenous demineralized tooth graft and plate measure: Stability Quotient of dental implant (SQDI) measure: pink esthetic score (PES) measure: facial marginal bone level (FMBL) sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: faculty of dentistry, kafrelsheikh University status: RECRUITING city: Kafr Ash Shaykh state: Kafrelsheikh zip: 214312 country: Egypt name: Walid elamrousy, PhD role: CONTACT phone: +201091444946 email: perioking1@gmail.com name: Dalia Rasheed Issa, PhD role: CONTACT email: dalia_rasheed@hotmail.com lat: 31.11174 lon: 30.93991 hasResults: False

 nctId: NCT06313203 id: 'TOMCAT' SMR-4066 briefTitle: HAI-Floxuridine, or SIRT, Combined With Gemox For Patients With Intra-Hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT) acronym: TOMCAT overallStatus: RECRUITING date: 2024-02-13 date: 2031-01 date: 2034-01 date: 2024-03-15 date: 2024-03-15 name: Oslo University Hospital class: OTHER briefSummary: Patients with intrahepatic cholangiocarcinoma (IHC) have relatively aggressive tumors, and the prognosis for most of these patients is dismal. Surgery is the only option that can offer potential cure, but only an estimated 20-25 % are amenable to resection. Down-staging conventional chemotherapy has a relatively low response rate (\< 50 %). Patients will be included into the respective treatment arms based on their tumour characteristics and disease stage, but also based on their ability/preferences, as HAI-FUDR/DEX requires going to Oslo every fortnight for the duration of the treatment and SIRT has some limitations regarding tumour distribution.

Data from the MSKCC has suggested a clinically relevant benefit from adding intrahepatic chemotherapy to systemic therapy. HAI-FUDR/DEX is not approved in Norway and can only be evaluated in a protocolized trial. Given the risk of distant disease progression with IHC, the addition of conventional systemic chemotherapy makes good clinical sense, and data from MSKCC supports this approach. SIRT is another modality also applied trans-arterially and directly into the tumour. This treatment is approved in Norway and available in Bergen and in Oslo. It is far less cumbersome to deliver and maintain than HAI-FUDR/DEX. The efficacy and safety of the two treatment groups, HAI-FUDR/DEX and SIRT, will be compared in a parallel cohort (non-randomized) design conditions: Intrahepatic Cholangiocarcinoma conditions: Chemotherapy Effect studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 800 type: ESTIMATED name: Floxuridine name: Selective Internal Radiation Therapy (SIRT) measure: Overall Survival (OS) at 3 years measure: Tumor response measure: Quality of Life by using EORTC QLQ-C30 measure: Quality of Life by using EQ-5D-5L measure: Assess the resection rate following downstaging measure: Assess complications, toxicity and side effects in treatment groups measure: Assess circulating cell-free (ctDNA) before and after treatment and correlate with treatment outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oslo University Hospital status: RECRUITING city: Oslo zip: 0424 country: Norway name: Anne H Longva, MD role: CONTACT phone: 90797458 phoneExt: +47 email: anlong@ous-hf.no name: Kristoffer Lassen, MD PhD role: CONTACT phone: 47616906 phoneExt: +47 email: krlass@ous-hf.no lat: 59.91273 lon: 10.74609 hasResults: False

 nctId: NCT06313190 id: SL-B2024-061 briefTitle: Combination of SBRT and Immunotherapy in Small Hepatocellular Carcinoma (HSBRT2402) acronym: HSBRT2402 overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2028-04-30 date: 2030-04-30 date: 2024-03-15 date: 2024-03-15 name: Sun Yat-sen University class: OTHER name: Fifth Affiliated Hospital, Sun Yat-Sen University name: Ningbo Medical Center Lihuili Eastern Hospital briefSummary: For inoperable small hepatocellular carcinoma (HCC), stereotactic body radiotherapy (SBRT) is an effective and safe local treatment. Despite satisfactory local control rate, the incidence of recurrence out the field remains substantial, with 2-year PFS of 31.9% to 60.9%. Therefore, a more effective treatment mode is urgently needed. Immune checkpoint inhibitors targeting PD-1/PD-L1 have shown substantial clinical benefits in advanced HCC as well as resected high-risk HCC. Recently, the combination of immunotherapy with SBRT has shown promising activity in HCC, but its utility in small HCC is unclear. The aim of this study was to investigate the efficacy and safety of SBRT followed by sintilimab (an anti-PD-1 antibody) in patients with recurrent or residual small HCC. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 140 type: ESTIMATED name: Stereotactic body radiotherapy name: Sintilimab measure: Progression-free survival (PFS) rate measure: Overall survival measure: Local control rate (DCR) measure: Treatment-related adverse events measure: Correlation between serum cytokines and overall survival and immune-related adverse events measure: Correlation between ctDNA and overall survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center city: Guangzhou state: Guangdong zip: 510060 country: China name: Mian Xi, MD role: CONTACT phone: +862087343385 email: ximian@sysucc.org.cn name: Mian Xi, MD role: PRINCIPAL_INVESTIGATOR name: Qi Zeng, MD role: SUB_INVESTIGATOR name: Yi Lu, MD role: SUB_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06313177 id: Soh-Med-24-03-03MS briefTitle: Syndesmotic Screw in Neutral Position Versus Maximum Ankle Dorsiflexion in Ankle Fractures; Comparative Study. overallStatus: RECRUITING date: 2024-03-10 date: 2025-03-10 date: 2025-03-10 date: 2024-03-15 date: 2024-03-15 name: Sohag University class: OTHER briefSummary: Ankle fracture is one of the most common orthopedic injuries. Approximately, 20% of surgically treated ankle fractures are associated with syndesmotic instability.According to the mechanism of the injury the syndesmotic disruption should be considered in Danis-Weber C-type fractures. However, such injuries were also frequently seen in Danis-Weber B-type fractures. Failure to detect and repair syndesmotic injuries early may result in poor clinical outcomes and complications affecting ankle function, such as long-term residual pain, post traumatic arthritis, and ankle impingement syndromes. Therefore, aggressive treatment is important when facing syndesmotic instability .

The distal tibiofibular syndesmosis is important for stability of the ankle mortise and thus for weight transmission and walking. Syndesmotic injuries are most commonly associated with fibular fractures, but they can also occur in isolation or with damage to the lateral ankle ligament after traumatic supination. The need for syndesmotic fixation of the distal tibiofibular joint has been controversia. fracture does not correlate reliably with the extent of the interosseous membrane tears identified on MRI of ankle fractures, and thus estimation of the integrity of the interosseous membrane and subsequent need for trans-syndesmotic fixation cannot be based solely on the level of the fibular fracture. An intraoperative syndesmotic stress test can establish the presence or absence of syndesmotic instability, evaluating the integrity of the syndesmosis by grasping the stabilised fibula with a hook or clamp and pulling it laterally. If more than 3 or 4 mm of lateral displacement occurs, syndesmotic fixation is necessary.

Most authors recommend surgical placement of a trans-fixation screw after anatomical reduction of the syndesmosis if a disruption is diagnosed to avoid complications.The main aims of treatment for dislocation of the distal tibiofibular syndesmosis are to restore the original anatomy and normal function and to recreate the stability of the ankle joint. The syndesmosis is traditionally fixed with a metallic screw, which is a method that has been used for decades and demonstrates good to excellent outcomes.

Some surgeons prefer Fixation of syndesmosis with screw in maximum ankle dorsiflexion and others prefer fixation in neutral position of ankle.in this study we are going to compare between these two conditions: Syndesmotic Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: syndesmosis fixation with screws measure: pain with AOFAS score sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag university Hospital status: RECRUITING city: Sohag country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06313164 id: SW009 briefTitle: The Impact of Oral Glutathione on Oxidative Damage and Glycated Hemoglobin (HbA1c) Levels in Type 2 Diabetes Patients overallStatus: COMPLETED date: 2023-06-20 date: 2024-01-30 date: 2024-02-29 date: 2024-03-15 date: 2024-03-15 name: S.LAB (SOLOWAYS) class: OTHER name: Center of New Medical Technologies briefSummary: This trial aims to assess the effectiveness of L-glutathione, supplemented with bioavailability boosters (tannin, low molecular weight chitosan, and polyethylene glycol), on improving antioxidant levels and glycemic control in patients with type 2 diabetes (T2D). The study is designed as a randomized, double-blind, placebo-controlled trial intending to enroll 240 T2D patients. The primary objective is to measure changes from baseline to 180 days in several key biomarkers, including endogenous reduced glutathione (GSH), oxidized glutathione (GSSG), 8-hydroxydeoxyguanosine (8-OHdG), and glycated hemoglobin (HbA1c), along with other metabolic parameters.

Hypothesis: The anticipated outcome is a significant increase in GSH levels and a decrease in markers of oxidative damage among participants receiving L-glutathione compared to those in the placebo group, potentially indicating improved antioxidant defenses and some effects on glycemic regulation in T2D patients. This trial aims to fill gaps in current research regarding the role of L-glutathione supplementation in managing oxidative stress and metabolic control in diabetes. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 217 type: ACTUAL name: enhanced glutathione name: placebo comparator measure: Reduced glutathione (GSH) levels in erythrocyte hemolysate change in patients with type 2 diabetes mellitus measure: Oxidized Glutathione (GSSG) Levels Change in Patients with Type 2 Diabetes Mellitus measure: 8-Oxoguanine (8-OHdG) Levels Change in Patients with Type 2 Diabetes Mellitus measure: Glycated Hemoglobin Concentration (HbA1c) Change in Patients with Type 2 Diabetes Mellitus measure: Fasting Glucose (FPG) Levels Change in Patients with Type 2 Diabetes Mellitus measure: Postprandial Glucose (PPG) Levels Change in Patients with Type 2 Diabetes Mellitus measure: Fasting Insulin (FPI) Levels Change in Patients with Type 2 Diabetes Mellitus measure: Postprandial Insulin (PPI) Levels Change in Patients with Type 2 Diabetes Mellitus sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center of New Medical Technologies city: Novosibirsk state: Novosibisk Region zip: 630090 country: Russian Federation lat: 55.0415 lon: 82.9346 hasResults: False

 nctId: NCT06313151 id: Soh-Med-24-02-02MD briefTitle: The 2019 EULAR/ACR Classification Criteria as Predictor of Organ Damage in Systemic Lupus Erythematosus Patients overallStatus: RECRUITING date: 2024-03-10 date: 2026-01-15 date: 2026-03-15 date: 2024-03-15 date: 2024-03-15 name: Sohag University class: OTHER briefSummary: The goal of this observational study is to investigate if the 2019 EULAR/ACR classification criteria can be used to assess organ damage in patients with systemic lupus erythematosus (SLE) and as predictor for prognosis . conditions: SLE, and Organ Damage Index studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED measure: prediction organ damage in SLE by using 2019 EULAR/ACR classification criteria. sex: ALL minimumAge: 16 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: Sohag University status: RECRUITING city: Sohag zip: 82511 country: Egypt name: alyaa A mohamed role: CONTACT phone: 01007218644 email: aliaa.abdelhameed@med.sohag.edu.eg name: mahmoud S allam role: CONTACT phone: 01091103331 email: m.sobhy.allam@gmail.com lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06313138 id: NantongJS briefTitle: Effectiveness of Health Literacy Enhancement Program Among Older Persons With Physical Multimorbidity overallStatus: COMPLETED date: 2023-07-15 date: 2023-12-25 date: 2024-01-30 date: 2024-03-15 date: 2024-03-15 name: Nantong University class: OTHER name: Chiang Mai University briefSummary: The study aims to examine the effectiveness of individual and family health literacy enhancement program among older persons with physical multimorbidity.

Specific objectives are:

1. To compare self-management, treatment burden, and symptom burden of older persons with physical multimorbidity between before and after receiving the individual and family health literacy enhancement program.
2. To compare self-management, treatment burden, and symptom burden of older persons with physical multimorbidity between those receiving the individual and family health literacy enhancement program and those receiving usual care.

Participants in the control group will receive usual care by physician and nurses during the experimental period. The usual care consists of physical examination, regular treatment protocol, patient education and telephone follow-up by community nurses.

Participants in the interventional group will receive the program which is a group-based intervention developed by the researcher based on the Individual and Family Self-Management Theory (IFSMT) (self-management skills) and the principle of Medagogy (PITS model: Pathophysiology, Indications, Treatments, Specifies) to improve patients' and their families' understanding of disease-related information and self-management skills consisting of goal setting and action plan, self-monitoring, solving problems and decision-making, and emotional control.The program will be divided into 8 sessions. Each session will be lasted for 2 hours with 1 intermittent break (10 minutes), and it will be held twice a week, and the last session will be held 1 week after the 7th session. Therefore, it will last for 5 weeks in total. conditions: Multiple Chronic Conditions；Diabetes；Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 140 type: ACTUAL name: The Individual and Family Enhancement Program measure: Self-management measure: Treatment burden measure: Symptom burden measure: Health literacy sex: ALL minimumAge: 60 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nantong University city: Nantong state: Jiang Su zip: 226001 country: China lat: 32.03028 lon: 120.87472 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-11-17 uploadDate: 2024-03-08T04:09 filename: ICF_000.pdf size: 3095464 hasResults: False

 nctId: NCT06313125 id: E-77082166-302.08.01-796166 briefTitle: Comparison of Exercise Effects in Individuals With Flatfoot overallStatus: RECRUITING date: 2024-04-21 date: 2024-05-31 date: 2024-08-31 date: 2024-03-15 date: 2024-03-15 name: Mustafa Kemal University class: OTHER briefSummary: Flexible flatfoot deformity, also known as flexible pes planus, is a common pathological condition characterized by decreased medial longitudinal arch height, eversion of the calcaneus and abduction of the forefoot, especially during loading. Conservative treatments are generally considered as the first step in treatment. In conservative treatments, exercise methods are one of the most frequently used interventions. It has been reported that exercise can improve functional outcomes such as navicular drop, plantar pressure distribution, foot posture, balance, and muscle strength in adults with flexible flatfoot. Although it is known that intrinsic muscle strengthening exercises are a frequently used intervention method in foot pathologies, there is a deficiency in the literature regarding studies investigating the effect of the combination of the most basic foot intrinsic muscle strengthening exercises with different exercise interventions on targeted clinical gains. However, the effect of three-dimensional foot-ankle exercise on flat feet is unknown. Additionally, there are a limited number of studies in the literature investigating the effects of hip abductor and external rotator muscle strength training on foot posture in individuals with flat feet. The aim of this thesis study, planned in the light of this information, is to determine the effects of three-dimensional foot-ankle extension exercises and hip abductor-external rotator muscle strengthening exercise primarily on navicular drop and MLA height in individuals with flexible flat feet; Secondly, it is to examine and compare the effects of static foot posture, hip abductor/external rotator, ankle circumference and intrinsic muscle strength on the functional performance of the lower extremity (endurance, dynamic balance and single leg forward jumping performance). To our knowledge, this study will be the first randomized controlled study to examine and compare the effects of two different exercise interventions that exercise the proximal and distal regions in flatfoot rehabilitation, and the results obtained will contribute to the development of better exercise and treatment programs in this population. In individuals with flat feet, when hip abductor/external rotator strengthening exercises or 3D foot-ankle extension exercises in the PNF pattern are added to short-foot exercise, MLA structure, muscle strength and lower extremity function will be improved more, and when these exercises are combined with short-foot exercise, they are comparable to intrinsic muscle strengthening exercises alone. The investigators hypothesized that it would produce superior clinical results. conditions: Flat Foot [Pes Planus] (Acquired), Unspecified Foot studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There will be three groups in the study. Short-foot exercise for the control group; short-foot and 3-dimensional foot-ankle exercise for the foot-ankle group; short-foot and clam exercise will be applied for the hip group. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The evaluator researcher and participants will be blinded to group allocation. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: 3-dimensional foot-ankle extension exercises name: Clam exercise name: Short-foot exercise measure: Medial longitudinal arch height-Navicular Drop Test measure: Static foot posture-Foot Posture Index-6 measure: Foot structure-Photopodometric analysis measure: Recording demographic and clinical information on the evaluation form sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Gazi University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation status: RECRUITING city: Ankara state: Çankaya zip: 06540 country: Turkey name: Dilek Ha Esen, PhD. c. role: CONTACT phone: +90533 815 23 71 email: dilekhandeesen@gmail.com name: Nihan Kafa, Prof. role: CONTACT email: fztnihankafa@gmail.com lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06313112 id: JCDC/BHR/23/036 briefTitle: Impact of Food Insecurity on Utilization of Maternal Healthcare Services and Birth Outcomes in Slums in Pune, India overallStatus: RECRUITING date: 2023-09-25 date: 2025-02 date: 2025-02 date: 2024-03-15 date: 2024-03-15 name: Hirabai Cowasji Jehangir Medical Research Institute class: OTHER briefSummary: The goal of this observational study is to assess household food insecurity among slum-dwelling women in India and to explore if household food insecurity is associated with utilization of maternal healthcare services, birth outcomes and infant growth.

The main questions it aims to answer are:

* Is the utilization of maternal healthcare services antenatally, during delivery, and postnatally associated with household food insecurity among slum-dwelling women in Pine, India?
* Is household food insecurity associated with birth outcomes and infant growth in these women?

Participants will be asked:

* For information related to socio-demographic characteristics, healthcare services utilization, food insecurity experience, dietary intake, and infant feeding indicators using a questionnaire.
* Anthropometric measurements of the participant, her husband and her infant/s will be collected.
* Two focused group discussions (FGDs) will also be conducted to gain insight into the perceptions of these women with respect to the utilization of maternal healthcare services. One FGD will be conducted for women who availed all the healthcare services and the other for those who did not adequately avail of the antenatal and postnatal services. conditions: Prenatal Care conditions: Food Insecurity conditions: Pregnancy Outcome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED name: Observational study measure: Percentage of women who availed at least three Antenatal Care (ANC) visits measure: Percentage of women who had contact with ASHA worker during pregnancy measure: Percentage of women who consumed at least 100 Iron Folic Acid tablets measure: Percentage of women who consumed deworming tablets at least once during pregnancy measure: Percentage of women who underwent delivery preparedness measure: Percentage of women with knowledge of key danger signs during pregnancy measure: Percentage of women who delivered at institution measure: Percentage of women who stayed at a facility for at least 24 hours post-delivery measure: Percentage of women who received post-natal care within a week of delivery measure: Association of demographic characteristics and household food insecurity scores with the indicators of utilization of healthcare services measure: Correlation of indicators of utilization of healthcare services with birth outcomes measure: Correlation of indicators of utilization of healthcare services with infant growth sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Hirabai Cowasji Jehangir Medical Research Institute status: RECRUITING city: Pune state: Maharashtra zip: 411001 country: India name: Anuradha V. Khadilkar, MBBS,MD role: CONTACT phone: 9850244305 email: anuradhavkhadilkar@gmail.com name: Rubina M. Mandlik, Ph.D. role: CONTACT phone: 9922959588 email: rubymandlik@hotmail.com lat: 18.51957 lon: 73.85535 hasResults: False

 nctId: NCT06313099 id: SakaryaAppliedSciencesUPNSC briefTitle: Parameters of the General Health Status of Prison Officers overallStatus: COMPLETED date: 2021-01-01 date: 2021-02-15 date: 2021-03-02 date: 2024-03-15 date: 2024-03-15 name: Pakize Nurgul Sen class: OTHER briefSummary: Introduction The working conditions of prison officers are very stressful. Today, it is known that stress affects the health status of individuals in many ways. In this study, it was aimed to evaluate the musculoskeletal system problems, fatigue severity, depression levels, and quality of life of prison officers and to examine the relationship between these parameters and the socio-demographic characteristics of the participants.

Method The study included a total of 141 volunteers. The musculoskeletal problems of the participants were evaluated with the Cornell Musculoskeletal Disorders Questionnaire, fatigue levels were evaluated with the Fatigue Severity Scale, depression levels were evaluated with the Beck Depression Inventory, and quality of life was evaluated with the Nottingham Health Profile. conditions: Musculoskeletal Pain conditions: Fatigue conditions: Depression conditions: Quality of Life studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 141 type: ACTUAL name: Survey measure: Cornell Musculoskeletal Disorders Questionnaire measure: Fatigue Severity Scale measure: Sleep Quality: Virtual Analog Scala: VAS measure: Beck Depression Inventory measure: Nottingham Health Profile sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Muğla E Type Closed Prison city: Muğla state: Menteşe zip: 48000 country: Turkey lat: 37.21807 lon: 28.3665 hasResults: False

 nctId: NCT06313086 id: SYSA1501-009 id: CTR20240245 type: REGISTRY domain: NMPA briefTitle: DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2028-02 date: 2024-03-15 date: 2024-03-15 name: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. class: INDUSTRY briefSummary: A Clinical Study to Evaluate the Efficacy and Safety of DP303c versus trastuzumab emtansine in patients with HER2-positive Advanced Breast Cancer conditions: HER2-positive Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: TREATMENT masking: NONE count: 442 type: ESTIMATED name: DP303c name: trastuzumab emtansine measure: Progression-free survival (PFS) by BIRC measure: Progression-free survival (PFS) by investigator measure: Overall Survival (OS) measure: Objective response rate (ORR) measure: Duration of response (DoR) measure: Incidence and severity of adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06313073 id: CHFL-BC-01 briefTitle: Neoadjuvant Radiotherapy for Breast Cancer overallStatus: RECRUITING date: 2024-04-01 date: 2026-02-15 date: 2026-02-15 date: 2024-03-15 date: 2024-03-15 name: Changhai Hospital class: OTHER briefSummary: The goal of this clinical trial is to compare the effects of neoadjuvant radiotherapy and adjuvant radiotherapy in patients with breast cancer.

The main questions it aims to answer are:

* The clinical effect of neoadjuvant radiotherapy for breast cancer was determined according to the postoperative specimens.
* Evaluate the acute and late toxicity of preoperative radiotherapy Participants will be randomly divided into two groups: the neoadjuvant radiotherapy group and the adjuvant radiotherapy group. conditions: Neoadjuvant Radiotherapy conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Neoadjuvant radiotherapy name: adjuvant radiotherapy measure: pCR measure: RCB sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changhai hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200433 country: China name: Huojun Zhang, M.D. role: CONTACT phone: +8613311732399 email: chyyzhj@163.com name: Huojun Zhang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06313060 id: 010 briefTitle: Efficacy of Carbonated Beverages in the Resolution of Alimentary Esophageal Impaction overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-01-01 date: 2027-01-01 date: 2024-03-15 date: 2024-03-15 name: Hospital del Río Hortega class: OTHER briefSummary: Objectives: To evaluate the efficacy of the administration of carbonated beverages in the resolution of dietary esophageal impaction, and to identify subgroups in which their effectiveness may be different: patients with/without esophageal diseases, with/without a history of impaction.

Methods: A clinical trial was conducted randomizing consecutive patients with a clinical diagnosis of dietary esophageal impaction to receive 200cc of carbonated drink or not at all, excluding patients with a previous diagnosis of non-esophageal stenosis that could not be overcome with a gastroscope and suspected impaction by non-alimentary foreign bodies, spines or bones. Subsequently, an endoscopic evaluation will be carried out in all cases, checking the presence or absence of a foreign body and removing it if necessary, as well as assessing and recording the possible underlying esophageal pathology.

A telephone follow-up will be carried out after 7 days, recording possible adverse events. conditions: Esophagus Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized clinical trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 354 type: ESTIMATED name: Coca-cola measure: Efficacy of carbonated beverage for disimpaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06313047 id: Doxorubacin in HCC briefTitle: Pharmacogenetic of Doxorubicin in HCC. overallStatus: COMPLETED date: 2021-01-01 date: 2023-12-15 date: 2023-12-30 date: 2024-03-15 date: 2024-03-28 name: Rehab Werida class: OTHER name: King Saud Bin Abdulaziz University for Health Sciences name: King Abdullah Bin Abdulaziz University Hospital briefSummary: The study included 81 HCC patients, both male and female. Prior to being assessed for eligibility, each recruited patient with HCC received a comprehensive review of their medical history, physical status, and laboratory results. Every research participant take part in the experiment and provided written informed consent. conditions: Hepatocellular Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 81 type: ACTUAL name: Doxorubicin measure: GSTP1 measure: CYP2B6 sex: ALL minimumAge: 20 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: King Abdullah bin Abdulaziz University Hospital city: Riyadh country: Saudi Arabia lat: 24.68773 lon: 46.72185 hasResults: False

 nctId: NCT06313034 id: GU-SBF-OPA-02 briefTitle: The Effect of Breastfeeding Training Given to Mothers With Vaginal Birth by Motivational Interview Technique overallStatus: RECRUITING date: 2023-05-01 date: 2024-03-15 date: 2024-03-15 date: 2024-03-15 date: 2024-03-15 name: Gümüşhane Universıty class: OTHER name: Karadeniz Technical University briefSummary: This study aimed to determine the effect of breastfeeding education given to mothers who gave birth vaginally using motivational interviewing technique on breastfeeding motivation, self-efficacy and attachment. The study will be conducted as a single-blind, randomized controlled trial. conditions: Breastfeeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The sample of the research will consist of mothers who gave primary vaginal birth (40 experimental group and 40 control group) primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: While it is known by the researcher whether the mothers are in the experimental or control group, it is not known by the mother. whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Breastfeeding education based on motivational interviewing technique measure: Mother Introductory Information Form measure: Primipara Breastfeeding Motivation Scale measure: Breastfeeding Self-Efficacy Scale Short Form measure: Mother-Baby Attachment Scale sex: FEMALE minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gümüşhane University status: RECRUITING city: Gümüşhane country: Turkey name: ÖZGE PALANCI AY role: CONTACT lat: 40.46001 lon: 39.47176 hasResults: False

 nctId: NCT06313021 id: 2023.12.03 briefTitle: Turkish Version of the Brief Assessment of Cognitive Impairment in Individuals With Stroke Scale overallStatus: RECRUITING date: 2024-01-15 date: 2024-04-15 date: 2024-05-15 date: 2024-03-15 date: 2024-03-15 name: Ataturk University class: OTHER briefSummary: Cognitive processing involves many interrelated cognitive domains, such as performing daily tasks, attention, language, and memory. 70% of individuals with stroke experience cognitive problems. Due to cognitive problems, individuals with stroke have difficulty processing and planning information. This situation negatively affects daily living activities and returning to work. Cognitive disorders that occur after stroke negatively affect the functional independence of individuals. At the same time, individuals with stroke have difficulty structuring and organizing information. The individual may not be able to pay sufficient attention during the activity in terms of planning, automatic attention and adaptation to the stages required by the job.

Cognitive evaluation should include cognition, orientation, and higher cortical functions because the cognitive process is a very complex process. Assessment methods frequently used in cognitive evaluation of stroke patients; Scales and tests such as Simple Mental Test, Mini Mental State Test, Montreal Cognitive Assessment Scale, Wechsler Memory and Intelligence Test are used. General problems with these evaluations; Some of them have a long application period, some of them have problems in perception of the patients, and some of them have a low power to distinguish the cognitive problems of the patients. When the Brief Assessment of Cognitive Impairment Scale, a newly introduced scale in the literature, is examined; It attracts attention because the items are very simple for patients to perceive, combine cognitive tests and cognitive questionnaires, have a short application period, and have not shown a ceiling or floor effect in previous studies. For all these reasons, this study was planned to conduct the Turkish validity and reliability study of the Brief Assessment of Cognitive Impairment Scale. conditions: Stroke conditions: Cognition studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED name: Reliability and Validity Study measure: Brief Assessment of Cognitive Impairment Scale measure: Mini Mental State Test measure: Sociodemographic Assessment sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ataturk University status: RECRUITING city: Erzurum country: Turkey name: Birol Önal, Dr. role: CONTACT phone: +904422311233 email: birol.onal@atauni.edu.tr lat: 39.90861 lon: 41.27694 hasResults: False

 nctId: NCT06313008 id: EMBA-VILDA-Response trial. briefTitle: Empagliflozin Versus Vildagliptin in CAD Patients With T2DM overallStatus: RECRUITING date: 2023-08-10 date: 2024-06-01 date: 2024-06-10 date: 2024-03-15 date: 2024-04-16 name: Damanhour University class: OTHER name: Tanta University briefSummary: We compared the cardioprotective effects of empagliflozin, an SGLT2 inhibitor, with those of vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, focusing on various inflammatory biomarkers lipid profile, and cardiac function, in patients with type 2 diabetes mellitus (T2DM). conditions: Coronary Artery Disease conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This was a prospective, randomized, double-dummy, blinded-endpoint, parallel-group trial that enrolled 120 CAD patients with T2DM. The patients were randomized 1: 1 for 6 months administration of empagliflozin or vildagliptin. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Empagliflozin 10 MG name: Vildagliptin 50 MG measure: LVEF % measure: Sortilin (ng/ml) measure: LDL (mg/dl) measure: hsCRP (mg/L) measure: HbA1c % measure: FBG (mg/dl) sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rehab Hussein Werida status: RECRUITING city: Damanhūr state: Elbehairah zip: 31527 country: Egypt name: Naglaa Khedr, Prof. role: CONTACT email: naglaa.khedr@pharm.tanta.edu.eg name: Lamiaa Khedr, Ass.Prof. role: CONTACT email: lamiaa_khedr@yahoo.com lat: 31.03408 lon: 30.46823 hasResults: False

 nctId: NCT06312995 id: T3DDY02 briefTitle: Investigation of a Medical Device for the Immobilisation of Radius and Ulna Fractures in Paediatric Patients acronym: T3DDY02 overallStatus: RECRUITING date: 2022-03-14 date: 2025-02-14 date: 2025-06-14 date: 2024-03-15 date: 2024-03-15 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Single-centre, randomised, controlled, non-profit study on a custom-made medical device for immobilisation of radius and ulna fracture in paediatric patients.

The aim of the study is to evaluate the benefits in terms of comfort, safety and efficacy resulting from the use of a customised 3D-printed wrist immobilisation device in children aged between 7 and 13 with a fracture of the distal metaphysis of radius or ulna of the 'green stick' type, compared to a control group treated with traditional immobilisation devices. The patients will be randomised between use of customised 3D- printed wrist immobilisisation device and plaster. conditions: Fractures, Bone studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: T3DDY01 name: PLASTER measure: Fracture Healing measure: Adverse event measure: Comfort of use of devices measure: Presence of skin lesions or other manifestations of intolerance to the device measure: Pain evaluation measure: Acceptance of the device measure: Structural analysis of devices measure: Usability for design purposes of the controlate sex: ALL minimumAge: 7 Years maximumAge: 13 Years stdAges: CHILD facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence zip: 50139 country: Italy name: Alessandro Zanardi, MD role: CONTACT phone: 055 5662908 email: alessadro.zanardi@meyer.it lat: 43.77925 lon: 11.24626 hasResults: False

 nctId: NCT06312982 id: BFH-niCRT-04 briefTitle: A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer: From a Multicenter Phase II Cohort to a Phase III Randomized Controlled Study overallStatus: RECRUITING date: 2024-02-20 date: 2026-12 date: 2026-12 date: 2024-03-15 date: 2024-03-15 name: Beijing Friendship Hospital class: OTHER name: Beijing Chao Yang Hospital name: Peking University Cancer Hospital & Institute name: CHINA-JAPEN FRIENDSHIP HOSPITAL name: Peking Union Medical College Hospital name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences name: Fudan University name: Changhai Hospital name: RenJi Hospital name: Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine name: Shandong Provincial Hospital name: Zhongnan Hospital of Wuhan University & Second Clinical Hospital of Wuhan University name: The First Affiliated Hospital of Zhengzhou University name: West China School of Medicine and West China Hospital, Sichuan University name: Sichuan Academy of Medical Sciences name: The Sixth Affiliated Hospital, Sun Yat-sen University name: The First Hospital of Jilin University name: First Hospital of China Medical University name: Army Medical Center of PLA name: The First Affiliated Hospital of Anhui Medical University briefSummary: The goal of this clinical trial is to compare the efficacy and safety of neoadjuvant chemoradiotherapy combined with tirelizumab compared with neoadjuvant chemoradiotherapy alone for neoadjuvant therapy in patients with locally advanced rectal cancer.

The main questions it aims to answer are:

To evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with tirelizumab compared with neoadjuvant chemoradiotherapy alone for neoadjuvant therapy in patients with locally advanced rectal cancer To assess rectal or anal retention as well as quality of life. Participants will receive a long course of NCRT (50 Gy / 25f, capecitabine 850-1000 mg / m2, BID, PO, D1-D5, QW) within the first 5 weeks. In regard to tumor immunotherapy, enrolled patients will receive tislelizumab (200 mg, iv) on the first day at week 2,5, and 8 after initiation of radiotherapy. Thereafter, patients will be treated with two 14-day cycles of the CAPOX（Q 3 w; D1 oxaliplatin, 130mg/m2,iv.gtt; D1-D14, capecitabine, 850-1000mg / m2, BID, PO）regimen. Two CAOPX regimens were treated one week apart. conditions: Locally Advanced Rectal Carcinoma studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 375 type: ESTIMATED name: Tislelizumab measure: CR measure: AE rate measure: NAR score measure: ORR measure: OPR measure: immune-related adverse event rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Friendship Hospital, Capital Medical University status: RECRUITING city: Beijing state: Beijing zip: 100050 country: China name: Yao Hongwei, M.D role: CONTACT phone: 86 13611015609 email: yaohongwei@ccmu.edu.cn lat: 39.9075 lon: 116.39723 facility: Beijing Friendship Hospital status: RECRUITING city: Beijing state: Beijing zip: 100050 country: China name: Zhongtao Zhang,, MD role: CONTACT phone: +86-13801060364 email: zhangzht@ccmu.edu.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06312969 id: 2022.301 briefTitle: Technological Gaming in Cancer Survivors (WINNERS) acronym: WINNERS overallStatus: RECRUITING date: 2023-02-23 date: 2024-09 date: 2025-02 date: 2024-03-15 date: 2024-03-15 name: Antonio Pérez Martínez class: OTHER name: Hospital Ruber Internacional name: Universidad Rey Juan Carlos briefSummary: HYPOTHESIS

1. Neurocognitive deficits in cancer survivors are underestimated. They represent a very limiting long-term side effect in this group of patients.
2. An individualized, planned and limited intervention using technological gaming can improve neurocognitive function in these pediatric patients by taking advantage of the plasticity of the central nervous system (CNS) in the pediatric age.
3. Changes can be demonstrated not only at the cognitive level, but also at the structural and functional level using neuroimaging techniques after our intervention.
4. In addition to the aforementioned benefits, this therapeutic tool can improve some clinical-analytical markers used in the follow-up of cancer survivors, such as immunological markers like lymphocyte populations and inflammatory cytokines.
5. The neurocognitive effects of this therapy are not only produced at the time of the intervention, but remain until months after the intervention.
6. The positive impact of the treatment is not only observed in the patients, but also in the psychological and emotional state of the family members.

VARIABLES

1. Clinically relevant improvement with moderate or large effect size in the following parameters as measured by neuropsychological tests.
2. Statistically significant changes in neuroimaging tests.
3. Statistically significant changes in immune and inflammatory biomarkers before and after treatment.

STUDY DESIGN In this clinical trial, randomized versus control group, unblinded, the aim is to demonstrate the neuropsychological, structural and functional benefit of an intervention using video games in child cancer survivors.

POPULATION OF THE STUDY The target population participating in the study will include patients of either sex aged 8-17 years who completed cancer treatment 1-5 years ago. They must have received treatment with neurotoxic potential: intrathecal/intraventricular chemotherapy, high-dose chemotherapy with crossing of the blood-brain barrier, CNS radiotherapy or hematopoietic stem cell transplantation (HSCT). conditions: Survivors of Childhood Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized versus control group clinical trial. primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: Video game based training measure: SDMT Test measure: Change in SDMT Test measure: Change in SDMT Test measure: "DIGITOS" Test measure: Change in "DIGITOS" Test measure: Change in "DIGITOS" Test measure: "TONI-4" test measure: Change in "TONI-4" test measure: Change in "TONI-4" test measure: "ROCF" test measure: Change in "ROCF" test measure: Change in "ROCF" test measure: "TFV" test measure: Change in "TFV" test measure: Change in "TFV" test measure: "STROOP" test measure: Change in "STROOP" test measure: Change in "STROOP" test measure: "TAVECI" test measure: Change in "TAVECI" test measure: Change in "TAVECI" test measure: "CPT3" measure: Change in "CPT3" measure: Change in "CPT3" measure: "BRIEF" survey measure: Change in "BRIEF" survey measure: Change in "BRIEF" survey measure: "BASC" survey measure: Change in "BASC" survey measure: Change in "BASC" survey measure: Statistically significant changes in neuroimaging tests measure: Statistically significant changes in neuroimaging tests measure: Immune and inflammatory biomarkers measure: Statistically significant changes in immune and inflammatory biomarkers measure: Statistically significant changes in immune and inflammatory biomarkers measure: Prevalence measure: Perception of the family measured by satisfaction survey sex: ALL minimumAge: 8 Years maximumAge: 17 Years stdAges: CHILD facility: Hospital La Paz status: RECRUITING city: Madrid zip: 28046 country: Spain name: Carlos Gonzalez-Perez, MD role: CONTACT phone: 0034917277223 email: carlos.gonzalez2@salud.madrid.org name: Antonio Perez-Martinez, PhD, MD role: PRINCIPAL_INVESTIGATOR name: Carlos R Gonzalez-Perez, MD role: SUB_INVESTIGATOR name: Eduardo Fernandez, PhD role: SUB_INVESTIGATOR name: Elena Moran role: SUB_INVESTIGATOR name: Juan Alvarez role: SUB_INVESTIGATOR name: Norberto Malpica role: SUB_INVESTIGATOR name: Diego Plaza, MD role: SUB_INVESTIGATOR name: Mario Alonso role: SUB_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06312956 id: 21C403 briefTitle: Multidimensional Evaluation of Patients' Affected by Obstructive Apnea Syndrome (OSAS) Before and After Ventilotherapy acronym: MULTI-OSAS overallStatus: RECRUITING date: 2024-02-29 date: 2025-06 date: 2026-02 date: 2024-03-15 date: 2024-03-15 name: Istituto Auxologico Italiano class: OTHER briefSummary: This observational study aims to evaluate multiple dimensions of health in patients with Obstructive Sleep Apnea Syndrome (OSAS), before and after three weeks of ventilotherapy.

Specifically, the study aims to identify pre- vs post-treatment differences in the following domains:

* cognitive performance
* blood expression of biomarkers related to neurodegeneration
* psychosocial wellbeing

Thus, patients will complete the following evaluations before (T0) and after (T1) ventilotherapy:

* neuropsychological standard assessment
* blood sampling
* psychosocial self-reported questionnaires conditions: Obstructive Sleep Apnea conditions: Sleep Disorder conditions: Well-Being, Psychological conditions: Cognitive Impairment conditions: Cognitive Change conditions: Neurologic Signs studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 65 type: ESTIMATED name: Continuous Positive Airway Pressure Ventilotherapy measure: Overall cognitive functioning measure: Selective attention measure: Memory and learning measure: Visuo-spatial abilities measure: Inhibition measure: Planning measure: Decision making measure: biomarkers of neurodegeneration measure: psychosocial wellbeing and satisfaction measure: Quality of life (perceived psycho-physical and socio-economic wellbeing and satisfaction) sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: IRCCS Istituto Auxologico Italiano status: RECRUITING city: Piancavallo state: VCO zip: 28824 country: Italy name: Sofia Tagini, PhD role: CONTACT phone: 00393339915288 email: s.tagini@auxologico.it hasResults: False

 nctId: NCT06312943 id: APHP180414 id: 2022-A02170-43 type: OTHER domain: France : Ministry of Health briefTitle: "Translating Articular Biomarkers Into Diagnoses" acronym: ARTBioSes overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-09 date: 2024-03-15 date: 2024-03-15 name: Assistance Publique - Hôpitaux de Paris class: OTHER name: Institut National de la Santé Et de la Recherche Médicale, France briefSummary: Early diagnosis is a key factor in the prevention and management of rheumatic diseases. Rheumatic diseases are classically diagnosed based on criteria combining clinical, biological and radiological features. However, in up to 20% of the cases, diagnoses remain unstated and underlying rheumatic diseases unclassified, which might lead to delayed specific treatment and unfavourable clinical outcomes. In addition, conventional methods could lack sensitivity and specificity for early diagnosis. Biological samples are attractive targets for the early detection of articular damage because they allow for collection of multiple levels of information from the clinic and the laboratory\]. Biological samples most frequently collected from patients with rheumatic diseases are synovial fluid by joint aspiration, blood by venous puncture and tissue specimen by surgery. The investigators hypothesize that in challenging situations, novel biomarkers detected from synovial fluid or articular tissues using both conventional (e.g. histology, immunodetection, PCR) and innovative (e.g. Raman spectroscopy, nanospectroscopy) laboratory tests may help refining diagnosis and better classifying patients with rheumatic diseases. conditions: Inflammatory and Non-inflammatory Bone and Joint Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Collection of joint fluid or tissue sample measure: Tissues and biofluid spectra using surface-enhanced Raman spectroscopy measure: Protein expression using immunodetection techniques and RNA expression using PCR measure: Tissues and biofluid spectra using surface-enhanced Raman spectroscopy measure: Protein expression using immunodetection techniques and RNA expression using PCR sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Service de Médecine Physique et de Réadaptation, Hôpital Cochin city: Paris state: IDF zip: 75014 country: France name: Christelle Nguyen, MD, PhD role: CONTACT phone: 00 33 1 58 41 29 45 email: christelle.nguyen2@aphp.fr name: MD, PhD role: CONTACT name: François Rannou, MD, PhD role: SUB_INVESTIGATOR name: Didier Borderie, MD, PhD role: SUB_INVESTIGATOR lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06312930 id: HSEARS20220816001-03 briefTitle: Transcranial Pulse Stimulation on Motor Cortex overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-08-20 date: 2024-08-20 date: 2024-03-15 date: 2024-03-18 name: The Hong Kong Polytechnic University class: OTHER briefSummary: Transcranial pulse stimulation (TPS) is a newly developed non-invasive brain stimulation (NIBS) technique from Austria \& Germany with highly promising applicability in neuropsychiatric disorders. Clinical trials have shown a beneficial effect of TPS in patients with Alzheimer's disease and depression. However, the mechanism of action of TPS treatment is unknown. There is a lack of controlled studies with sufficient sample size to draw reliable conclusions on the modulatory effect of TPS. The primary motor cortex is a common target when investigating the neuromodulation effect of NIBS techniques. Here, a randomized, cross-over, double-blind, sham-controlled clinical trial is proposed to probe the effects of TPS over the primary motor cortex on modulating motor response and motor behavior. conditions: Healthy Adults studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Transcranial pulse stimulation measure: Change in movement time in nine-hole peg test after TPS measure: Change in reaction time in Deary-Liewald reaction time task after TPS measure: The influence of motor excitability measured by resting motor threshold (RMT) on post-TPS task performance measured by nine-hole peg test and Deary-Liewald reaction time task sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Georg Kranz, PhD city: Hong Kong country: Hong Kong name: Georg Kranz, PhD role: CONTACT phone: 27664838 email: georg.kranz@polyu.edu.hk name: Georg S. Kranz, PhD role: PRINCIPAL_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06312917 id: 2023PHB183 briefTitle: Effect of Physical Activity Intervention on Overweight and Obese Patients With Endometrial Cancer overallStatus: COMPLETED date: 2023-06-01 date: 2023-12-30 date: 2024-02-01 date: 2024-03-15 date: 2024-03-15 name: Peking University People's Hospital class: OTHER briefSummary: This study evaluated the clinical outcome of exercise management on patients with endometrial cancer treated with fertility preservation, including the effect of complete response rate, complete response time, recurrence rate, recurrence time, etc., and physical composition, to evaluate the effectiveness of physical activity on weight management. conditions: Endometrium Cancer conditions: Physical Activity conditions: Weight Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 72 type: ACTUAL name: Physical activity measure: Body weight measure: BMI measure: physical activity level measure: serum total cholesterol measure: Waist Hip Ratio measure: triglyceride sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Peking University People's Hospital city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06312904 id: 2023-GSP-QN-7 briefTitle: Paravertebral Block for Postoperative Analgesia in Children Undergoing Lateral Incision Cardiac Surgery With CBP overallStatus: NOT_YET_RECRUITING date: 2024-03-11 date: 2024-11-30 date: 2024-12-30 date: 2024-03-15 date: 2024-03-15 name: Chinese Academy of Medical Sciences, Fuwai Hospital class: OTHER briefSummary: This study aims to compare the effect of paravertebral block and local infiltration anesthesia on postoperative analgesia in children undergoing lateral incision cardiac surgery with cardiopulmonary bypass. The researchers hope to investigate whether children who undergo paravertebral block experience less postoperative pain, have fewer postoperative complications, and recover more quickly. conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: paravertebral block name: Local infiltration anesthesia measure: opioid consumption during the first 24h after surgery measure: FPS-R scale recorded at 6, 12, 18 and 24h postoperatively measure: The rate of opioid treatment for remedial analgesia between groups measure: Length of postoperative mechanical ventilation measure: Length of ICU/hospital stay measure: The incidence of respiratory depression measure: The rate of postoperative nausea and vomiting (PONV) during the 24h postoperatively sex: ALL minimumAge: 6 Years maximumAge: 14 Years stdAges: CHILD typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2024-02-26 uploadDate: 2024-03-08T09:29 filename: Prot_SAP_ICF_000.pdf size: 294106 hasResults: False

 nctId: NCT06312891 id: VOHRLTIAM briefTitle: Value of Heart Rate Lowering Therapy in Acute Myocarditis overallStatus: RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-06-01 date: 2024-03-15 date: 2024-03-15 name: Assiut University class: OTHER briefSummary: To study the value of heart rate lowering therapy "pharmacological rest" on the short term in cases of myocarditis without LV dysfunction. conditions: Myocarditis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Ivabradine measure: Value of Heart Rate Lowering Therapy in Acute Myocarditis sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Heart Hospital status: RECRUITING city: Assiut country: Egypt name: sara mahmoud, master role: CONTACT phone: 01016862195 email: saramahmoud199783@gmail.com lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06312878 id: IRBN052024/CHUSTE briefTitle: CT Features of Interrupted Inferior Vena Cava With Azygous Continuation overallStatus: RECRUITING date: 2024-03-01 date: 2024-03-31 date: 2024-03-31 date: 2024-03-15 date: 2024-03-15 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: Inferior vena cava (IVC) is the largest vein is the body, draining blood from the abdomen, pelvis and lower extremities. IVC anomalies can be congenital or acquired.

The origins of these anomalies are not entirely clear, and their incidence is uncertain.

Imaging plays a pivotal role in diagnosis to prevent misinterpretation. CT scan is a quick, available, and suitable imaging modality in emergency setting.

The aim of this retrospective monocentric study was of describe CT features of interrupted suprarenal inferior vena cava with azygous continuation. conditions: Anatomical Variant of the Inferior Vena Cava studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 10 type: ESTIMATED name: Describe the anatomy of the IVC in the case of an anatomical variant measure: Describe CT features of interrupted suprarenal inferior vena cava with azygous continuation measure: Describe CT features of interrupted suprarenal inferior vena cava with azygous continuation measure: Describe association with polysplenic syndrome measure: Describe association with polysplenic syndrome measure: Describe association with polysplenic syndrome measure: Describe association with polysplenic syndrome measure: Describe association with polysplenic syndrome measure: Describe association with polysplenic syndrome measure: Describe circumstances of discovering the interrupted IVC measure: Describe circumstances of discovering the interrupted IVC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Saint-Etienne status: RECRUITING city: Saint-Priest-en-Jarez zip: 42270 country: France name: Sylvain Grange, MD role: CONTACT phone: (0)477829066 phoneExt: +33 email: grangesylvain@hotmail.fr name: Sylvain Grange, MD role: PRINCIPAL_INVESTIGATOR name: Rémi Grange, MD role: SUB_INVESTIGATOR lat: 45.47501 lon: 4.37614 hasResults: False

 nctId: NCT06312865 id: IXTEGYPT briefTitle: Intermittent Exotropia in Egyptian Population overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-07 date: 2025-11 date: 2024-03-15 date: 2024-03-15 name: Assiut University class: OTHER briefSummary: Strabismus is one of the most frequent ocular problems among developmentally normal children. The prevalence of strabismus varies among different regions, ranging from 0.06% in Japan to 5.65% in China. Exotropia is reported to be the most prevalent type of deviation in many of these studies. About 48-92% of the exotropic patients have intermittent exotropia (IXT). Jenkins reported that the prevalence of exodeviation was higher in countries near the Equator. Its prevalence is also higher in subequatorial Africa, the Middle East, and East Asia (where there is plenty of sunshine) in comparison to the USA and Central Europe. Intermittent exotropia is a disorder of binocular eye movement control, where one eye intermittently turns outward. The outward deviation is greatest and likely occurs at far distances viewing, when the oculomotor convergence effort is weakest, and occurs frequently when the patient is under stress, tired, ill, or in particular test situations. X(T) can also occur at near as convergence insufficiency. conditions: Exotropia studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 600 type: ESTIMATED name: Ophthalmic exam measure: The difference in demographic criteria in Egyptian population sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06312852 id: Antenatal steroids & clotting briefTitle: Impact of Antenatal Steroids on Coagulation. overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04 date: 2025-05 date: 2024-03-15 date: 2024-03-15 name: Assiut University class: OTHER briefSummary: Aim of the research :

1- Detection of the presence or absence of any effect of antenatal corticosteroid administration on coagulopathy, fibrinolysis, and other haematological markers. conditions: Corticosteroids Adverse Reaction studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 45 type: ESTIMATED measure: Antenatal corticosteroids impact on Coagulopathy measure: Follow up for cases on corticosteroid therapy sex: FEMALE minimumAge: 15 Years maximumAge: 45 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06312839 id: IRBN032024/CHUSTE briefTitle: Preoperative Arterial Embolization Before Oncologic Esophagectomy as a Technique for Ischemic Gastric Conditioning overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2025-12 date: 2024-03-15 date: 2024-03-15 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: This retrospective monocentric comparative study aims to assess the efficacy of preoperative ischemic conditioning, in preventing anastomotic leakage in esophageal cancer surgery. Two groups were included : a surgery-alone group (control group) and a PreopAE group (study group) treated with an embolization procedure before esophagectomy. Collected data included patient characteristics, embolization procedure details, surgical outcomes, and postoperative complications.

The primary outcome was the efficacy of preoperative ischemic conditioning in preventing anastomotic leakage, assessed through CT scans. Secondary outcomes included analyzing safety of ischemic gastric conditioning, hypertrophy of the gastroepiploic artery in embolized patients and comparing hospital stay length and postoperative mortality. conditions: Esophageal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED name: Collecting data from the medical record measure: Measurement of the effectiveness of preoperative ischaemic conditioning in reducing anastomotic leakage in patients undergoing oesophagectomy. measure: Measurement of the effectiveness of preoperative ischaemic conditioning in reducing anastomotic leakage in patients undergoing oesophagectomy. measure: Measurement of the effectiveness of preoperative ischaemic conditioning in reducing anastomotic leakage in patients undergoing oesophagectomy. measure: Safety of ischemic gastric conditioning measure: Hypertrophy of the gastroepiploic artery measure: Comparing hospital stay length measure: Comparing postoperative mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Saint-Etienne city: Saint-Priest-en-Jarez zip: 42270 country: France name: Rémi Grange, MD role: CONTACT name: Sylvain Grange, MD role: SUB_INVESTIGATOR name: Rémi Grange, MD role: PRINCIPAL_INVESTIGATOR name: Zoé Sahut, resident role: SUB_INVESTIGATOR lat: 45.47501 lon: 4.37614 hasResults: False

 nctId: NCT06312826 id: KCT0007417 id: 2022-0661 type: OTHER domain: Asan Medical Center Institutional Review Board briefTitle: Abbreviated MRI Using Gadoxetic Acid Versus Ultrasonography for Surveillance of Early-stage HCC in Patients at High Risk overallStatus: RECRUITING date: 2022-08-26 date: 2024-12 date: 2027-12 date: 2024-03-15 date: 2024-03-15 name: So Yeon Kim class: OTHER briefSummary: Hepatocellular carcinoma (HCC) is the third most frequent cause of cancer-related deaths worldwide. The incidence of HCC has been rapidly rising worldwide over the last two decades. In order to improve survival with curative treatment, regular surveillance to detect early-stage HCC is recommended for at-risk populations. Although ultrasonography (US) has been endorsed as the primary surveillance tool for HCC, a recent meta-analysis found that US has a sensitivity of 47% for detecting early-stage HCC, and its sensitivity for detecting early-stage HCC has been questioned. Many recent studies have explored the potential of alternative surveillance tools for HCC other than US, particularly for high-risk patients. Although complete gadoxetic acid-enhanced magnetic resonance imaging (MRI) demonstrated excellent performance, its high cost and long examination time can hamper its widespread adoption. Abbreviated MRI (AMRI) including hepatobiliary-phase imaging is a promising option to detect potential indicators of HCC, maintaining the benefits of highly sensitive imaging while reducing the examination time by omitting dynamic contrast-enhanced imaging. Because US is the current primary surveillance tool for HCC, this new surveillance tool must be compared with US in a prospective randomized comparative design.

Thus, the hypothesis to be proved in this study is as follows: AMRI with gadoxetic acid will show a significantly higher detection rate compared to US for the detection of early-stage HCC in patients with cirrhosis and at high risk of developing HCC, defined as an estimated annual HCC risk of higher than 5%. We will also analyze whether the false-referral rate of AMRI with gadoxetic acid is not compromised by its high detection rate. conditions: Liver Cirrhosis conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 806 type: ESTIMATED name: Abdominal US name: AMRI measure: Detection rate of patients with early stage HCC measure: Detection rate of patients with very early stage HCC measure: False referral rate of patients with early stage HCC measure: False referral rate of patients with very early stage HCC sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Asan Medical Center status: RECRUITING city: Seoul state: Songpa-gu zip: 05505 country: Korea, Republic of name: So Yeon Kim, MD, PhD role: CONTACT phone: 82-2-3010-7166 email: sykim.radiology@gmail.com name: Hyo Jung Park, MD, PhD role: CONTACT phone: 82-2-3010-7166 email: happyeahj@gmail.com name: Jonggi Choi, MD, PhD role: SUB_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Asan Medical Center status: RECRUITING city: Seoul state: Songpa-gu zip: 05505 country: Korea, Republic of name: So Yeon Kim, MD, PhD role: CONTACT phone: 82-2-3010-6575 email: sykim.radiology@gmail.com name: Hyo Jung Park, MD, PhD role: CONTACT phone: 82-2-3010-6575 email: happyeahj@gmail.com name: Jonggi Choi, MD, PhD role: SUB_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06312813 id: 2023-296 briefTitle: Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea overallStatus: RECRUITING date: 2024-02-27 date: 2028-12 date: 2028-12 date: 2024-03-15 date: 2024-03-15 name: Wright State University class: OTHER briefSummary: Rosacea is a common skin condition associated with easy blushing and red face; many patients with rosacea react to sunlight with increased redness. The purpose of this study is to determine if the use of a topical medication will help reduce sunlight induced redness and irritation in patients with rosacea. conditions: Rosacea studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: Imipramine name: Amitriptyline name: Vehicle measure: Ultraviolet B induced erythema change with 4% imipramine measure: Ultraviolet B induced erythema change with 4% imipramine measure: Ultraviolet B induced erythema change with 4% imipramine measure: Ultraviolet B induced erythema change with 4% imipramine measure: Ultraviolet B induced erythema change with 4% amitriptyline measure: Ultraviolet B induced erythema change with 4% amitriptyline measure: Ultraviolet B induced erythema change with 4% amitriptyline measure: Ultraviolet B induced erythema change with 4% amitriptyline measure: Tolerability of 4% imipramine on facial skin measure: Tolerability of 4% imipramine on facial skin measure: Tolerability of 4% imipramine on facial skin measure: Tolerability of 4% imipramine on facial skin measure: Tolerability of 4% amitriptyline on facial skin measure: Tolerability of 4% amitriptyline on facial skin measure: Tolerability of 4% amitriptyline on facial skin measure: Tolerability of 4% amitriptyline on facial skin sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wright State Physicians status: RECRUITING city: Fairborn state: Ohio zip: 45324 country: United States name: Pharmacology Translational Unit role: CONTACT phone: 937-245-7500 email: pturesearch@wrightstatephysicians.org name: Travers role: PRINCIPAL_INVESTIGATOR lat: 39.82089 lon: -84.01938 hasResults: False

 nctId: NCT06312800 id: LeWitt02 briefTitle: Acamprosate and Methazolamide for Essential Tremor overallStatus: WITHDRAWN date: 2016-03 date: 2017-06 date: 2017-12 date: 2024-03-15 date: 2024-03-15 name: Henry Ford Health System class: OTHER briefSummary: This is an investigator initiated study is designed to evaluate the anti-tremor benefits of two marketed medications, methazolamide and acamprosate in subjects with a diagnosis of essential tremor (ET). conditions: Essential Tremor studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 0 type: ACTUAL name: Acamprosate name: Placebo name: Methazolamide measure: Fahn-Marin-Tolosa rating scale (FMTRS) Part A sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henry Ford West Bloomfield Hospital city: West Bloomfield state: Michigan zip: 48322 country: United States lat: 42.56891 lon: -83.38356 hasResults: False

 nctId: NCT06312787 id: VX23-118-002 briefTitle: A Study to Evaluate the Relative Bioavailability and Food Effect of a VX-118 Tablet Formulation overallStatus: RECRUITING date: 2024-04-02 date: 2024-05 date: 2024-05 date: 2024-03-15 date: 2024-04-11 name: Vertex Pharmaceuticals Incorporated class: INDUSTRY briefSummary: The purpose of this study is to evaluate the relative bioavailability, effect of food on the pharmacokinetic parameters, and safety and tolerability, of a tablet formulation of VX-118 in healthy participants. conditions: Cystic Fibrosis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: VX-118 measure: Maximum Observed Plasma Concentration (Cmax) of VX-118 measure: Area Under the Concentration Versus Time Curve (AUC) of VX-118 measure: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Celerion - Lincoln status: RECRUITING city: Lincoln state: Nebraska zip: 68502 country: United States lat: 40.8 lon: -96.66696 hasResults: False

 nctId: NCT06312774 id: IRAS 333853 briefTitle: Feasibility of Proteomics in Chronic Lung Disease With Sarcopenia overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2025-11-07 date: 2027-01-04 date: 2024-03-15 date: 2024-03-15 name: University College, London class: OTHER briefSummary: Sarcopenia, the loss of muscle mass and strength with ageing, is a prevalent condition in older adults, particularly those with chronic lung diseases like COPD and interstitial lung disease. The condition exacerbates the decline in physical ability, leading to decreased mobility, impaired quality of life, and increased disability. Sarcopenia's prevalence varies across populations, estimated to affect up to 10% of adults over 60 worldwide, with higher rates reported in studies employing consensus definitions of sarcopenia. The prevalence is even higher in patients with chronic lung diseases, reaching up to 26.6%. Sarcopenia's impact on health-related quality of life has been widely investigated. The condition is associated with various comorbidities, including chronic heart failure, obesity, diabetes, and chronic kidney disease, all negatively impacting the quality of life.

The proposed study's primary aim is to assess the feasibility of the FACS (finding, assessing, confirming, severity) approach in determining sarcopenia's prevalence in the chronic lung disease population. FACS includes screening, strength measurements, and bioelectrical impedance analysis (BIA) to confirm sarcopenia.

The study will also explore potential mechanisms associated with sarcopenia in this population, using proteome and single-cell transcriptome profiles. These multi-omics approaches provide a comprehensive view of the cellular and molecular changes underlying sarcopenia.In particular, the study will evaluate patient acceptance, time efficiency of each test, and recruitment effectiveness. The outcomes will guide the design and execution of subsequent, larger studies and provide preliminary data for power calculation for the full-scale study. conditions: Sarcopenia conditions: Chronic Lung Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 49 type: ESTIMATED name: This is observational study measure: Sarcopenia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06312761 id: Oral T-12 briefTitle: Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17 acronym: OralT12 overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-15 date: 2024-03-15 name: University of Washington class: OTHER name: Washington State University briefSummary: This study will be performed in normal men whose endogenous testosterone production has been temporarily suppressed by the administration of a single dose of 120 mg of the oral GnRH antagonist Relugolix, which is approved for the treatment of prostate cancer, and can suppress endogenous testosterone biosynthesis for 48-72 hours after a single dose. conditions: Hypogonadism, Male studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 10 type: ESTIMATED name: Relugolix 120Mg Tab name: Curcumin name: Testosterone Undecanoate 237 MG Oral Capsule measure: average serum testosterone after dosing on day 2 measure: average serum testosterone after dosing on day 3 measure: Maximum concentration measure: time to maximum concentration measure: area-under-the curve measure: elimination phase half-life sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06312748 id: 138675 briefTitle: Novel Approaches for Improving Vascular Function in Veterans With HFpEF overallStatus: RECRUITING date: 2021-05-19 date: 2028-09-30 date: 2030-09-30 date: 2024-03-15 date: 2024-03-21 name: D. Walter Wray class: OTHER name: US Department of Veterans Affairs briefSummary: This project will evaluate the impact of L-Citrulline, tetrahydrobiopterin (BH4), and atorvastatin administration on physical capacity and vascular function in Veterans with heart failure with preserved ejection fraction (HFpEF). conditions: HFpEF - Heart Failure With Preserved Ejection Fraction conditions: Inflammation studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: A block randomization method will be used to randomize participants into equal groups and will be handled by investigational pharmacist. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: L-Citrulline name: Placebo for L-Citrulline name: BH4 name: Placebo for BH4 name: Atorvastatin name: Placebo for Atorvastatin measure: Flow-mediated dilation (FMD) measure: Passive Limb Movement (PLM) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: George E. Whalen VA Medical Center status: RECRUITING city: Salt Lake City state: Utah zip: 84128 country: United States name: Walter Wray role: CONTACT phone: 858-205-3078 email: walter.wray@hsc.utah.edu lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06312735 id: 230405 briefTitle: VR for Patients With Chronic Pain (Wait & Work) overallStatus: RECRUITING date: 2023-10-01 date: 2024-03-31 date: 2024-09-30 date: 2024-03-15 date: 2024-03-18 name: University of Twente class: OTHER briefSummary: This cluster-RCT evaluates the effect of therapeutic virtual reality (VR) on patients with chronic musculoskeletal pain (CMP) who are on a waiting list to receive pain treatment. The used VR application, Reducept, offers pain education and pain management techniques. This home-based, stand-alone, immersive VR intervention was used daily for four weeks in the intervention group. The control group received standard care (no treatment). Primary outcome measure for this study was health-related quality of life, secondary outcome measures included various pain-related variables (e.g. pain self-efficacy and acceptance. Outcome variables will be measured after four weeks and follow-up after six months. conditions: Chronic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: VR (Reducept) measure: Change in quality of life measured using the short-form 12 (SF-12) measure: Change in pain intensity measured using the numeric pain rating scale (NPRS) measure: Change in pain catastrophizing measured using the pain catastrophizing scale (PCS) measure: Change in pain self-efficacy measured using the pain self-efficacy questionnaire (PSEQ) measure: Change in pain acceptance measured using the chronic pain acceptance questionnaire (CPAQ-8) measure: Change in feelings of anxiety and depression measured using the hospital anxiety and depression scale (HADS) measure: Change in quality of care measured using the client satisfaction questionnaire (CSQ-8) measure: Change in medication use measured using an open-ended question sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Revalidatie Friesland status: RECRUITING city: Emmeloord state: Friesland zip: 8303BX country: Netherlands name: Heleen Reinders-Messelink, PhD role: CONTACT lat: 52.71083 lon: 5.74861 facility: Deventer Ziekenhuis status: RECRUITING city: Deventer state: Overijssel zip: 7416SE country: Netherlands name: Leonie Oolbekkink, MSc role: CONTACT lat: 52.255 lon: 6.16389 facility: Roessingh rehabilitation center status: RECRUITING city: Enschede state: Overijssel zip: 7522AH country: Netherlands name: Marjolein Stegeman, MSc role: CONTACT lat: 52.21833 lon: 6.89583 facility: Nocepta status: RECRUITING city: Hengelo state: Overijssel zip: 7555DL country: Netherlands name: Nelson Oliveira, MSc role: CONTACT lat: 52.26583 lon: 6.79306 hasResults: False

 nctId: NCT06312722 id: PR1309 briefTitle: Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study acronym: PEAK overallStatus: RECRUITING date: 2024-02-07 date: 2031-02-07 date: 2031-02-07 date: 2024-03-15 date: 2024-03-15 name: Urotronic Inc. class: INDUSTRY briefSummary: The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System. conditions: Benign Prostatic Hyperplasia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, single-arm, multi-center, post market clinical trial primaryPurpose: TREATMENT masking: NONE count: 92 type: ESTIMATED name: Optilume® BPH Catheter System measure: The primary efficacy endpoint is the average IPSS improvement from baseline to 12 months. measure: Semen Sub-Study Safety Secondary Endpoint sex: MALE minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Urotronic, INC status: RECRUITING city: Plymouth state: Minnesota zip: 55441 country: United States name: Jill Moland role: CONTACT email: jmoland@laborie.com name: Brandon Shuler role: CONTACT email: bshuler@laborie.com lat: 45.01052 lon: -93.45551 hasResults: False

 nctId: NCT06312709 id: STUDY00021288 id: K23HL159240 type: NIH link: https://reporter.nih.gov/quickSearch/K23HL159240 briefTitle: teleABLE to Reduce Post-Stroke Sedentary Behavior overallStatus: RECRUITING date: 2024-04-04 date: 2026-01-31 date: 2026-07-31 date: 2024-03-15 date: 2024-04-10 name: University of Minnesota class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The goal of this clinical trial to test whether a remotely delivered behavioral activation-based intervention called "teleABLE" works better than a health education intervention for (1) reducing sitting time and (2) improving health-related quality among adults who were diagnosed with stroke within the past 12 months.

Participants in this study will:

* Complete questionnaires at Weeks 1, 8, and 24
* Wear an activPAL monitor at Weeks 1, 8, and 24
* Participate in the teleABLE intervention (12 sessions) or the health education intervention (6 sessions)
* Complete an interview at Week 24 conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 92 type: ESTIMATED name: teleABLE (telehealth-delivered Activating Behavior for Lasting Engagement) name: Health Education measure: Between-group difference in change scores on health-related quality of life measure: Between-group difference in change in sedentary behavior measure: Between-group difference in change in sedentary behavior measure: Between-group difference in change scores on health-related quality of life measure: Between-group difference in change in step count measure: Between-group difference in change in step count measure: Between-group difference in change in total activity retention measure: Between-group difference in change in total activity retention sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: School of Kinesiology, University of Minnesota status: RECRUITING city: Minneapolis state: Minnesota zip: 55455 country: United States name: Karli Jahnke, MOT, OTR/L role: CONTACT phone: 612-626-4046 email: dwell@umn.edu lat: 44.97997 lon: -93.26384 hasResults: False

 nctId: NCT06312696 id: SMT briefTitle: Normalizing Cervical Intersegmental Kinematics With Spinal Manipulative Therapy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-04-01 date: 2027-04-01 date: 2024-03-15 date: 2024-03-15 name: University of Minnesota class: OTHER briefSummary: The broad long-term objective is to develop an objective biomarker for spinal health based on aberrant or abnormal movement patterns during functional activities to better target spinal manipulation therapy (SMT) and other conservative treatments. The central hypotheses are a) that aberrant spinal motions and their location (area and level) are indicative of underlying spinal dysfunction, and b) that quantified 3D cervical spine intersegmental and global motion patterns during functional tasks can be used as a biomarker for subsequent clinical studies aimed at normalizing cervical kinematics.

Specific Aim: Determine the extent to which SMT can modulate, or normalize, intersegmental motion in patients with neck pain. Rationale: SMT is a force-based biomechanical event whose hypothesized mechanism of action relies on moving the segment into the para-physiological zone, resulting in normalization of spinal kinematic function. Hypothesis: Severity of abnormal or aberrant motion, identified in those with NP, will improve following SMT. Approach: Participants with chronic mechanical neck pain will be recruited and randomized into one of three groups: 1) No Treatment, 2) Light Massage (pseudo- sham), and 3) Spinal Manipulative Therapy. Using a repeated measures study design, metrics of quality of spinal motion will be compared before and after the prescribed intervention. conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants with chronic mechanical neck pain will be recruited and randomized into one of three groups: 1) No Treatment, 2) Light Massage (pseudo- sham), and 3) Spinal Manipulative Therapy. Using a repeated measures study design, metrics of quality of spinal motion will be compared before and after the prescribed intervention. primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: SMT name: Light Massage measure: Intersegmental and Global Range of Motion measure: Neck pain intensity measure: Neck disability measure: physical function measure: depression measure: sleep disturbance measure: Pain interference measure: Fear of pain assessment measure: Overall function assessment sex: ALL minimumAge: 18 Years maximumAge: 39 Years stdAges: ADULT hasResults: False

 nctId: NCT06312683 id: 23-2111 briefTitle: Rifaximin for the Secondary Prevention of Recurrent Pouchitis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-03-15 date: 2024-03-18 name: University of North Carolina, Chapel Hill class: OTHER name: Bausch Health Americas, Inc. briefSummary: Although many people will develop recurrent pouchitis (inflammation of the ileal pouch-anal anastomosis or J-pouch after colectomy for ulcerative colitis) after an initial episode of pouchitis, there are currently no effective treatments to prevent recurrent pouchitis. The goal of this study is to evaluate the potential for rifaximin, an antibiotic, to prevent recurrent pouchitis after treatment for an initial episode of pouchitis. In this study, all patients will be given daily rifaximin for one year after being treated for an initial episode of pouchitis. This study will examine whether people are willing to take rifaximin for one year with the goal of preventing recurrent pouchitis. Additionally, this study will examine whether patients experience any unexpected side effects of rifaximin therapy. The information gained through this study will potentially be helpful in improving the ability to prevent recurrent pouchitis in patients who have a colectomy for ulcerative colitis. conditions: Pouchitis studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 8 type: ESTIMATED name: Rifaximin 550 MG Oral Tablet [XIFAXAN] measure: Percentage of Participants Who Develop Recurrent Pouchitis sex: ALL minimumAge: 18 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of North Carolina city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Mikki Sandridge role: CONTACT phone: 919-843-3873 email: mikki_sandridge@med.unc.edu name: Edward Barnes, MD, MPH role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06312670 id: CASE2823 briefTitle: Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2026-03-01 date: 2026-03-01 date: 2024-03-15 date: 2024-04-02 name: Pedro Barata, MD, MSc class: OTHER name: ESSA Pharma Inc. briefSummary: The purpose of this study is to study the effects of EPI-7386 in combination with Enzalutamide on participants diagnosed with prostate cancer. The main goals of this study are to evaluate the antitumor activity of EPI-7386 in combination with enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC), and to evaluate the pharmacokinetics (PK) of EPI-7386 when dosed in combination with enzalutamide. Participants will will take the study drug, EPI-7360, twice a day by mouth and enzalutamide once a day by mouth, alongside clinic visits every two weeks. conditions: Metastatic Hormone-sensitive Prostate Cancer (mHSPC) conditions: Prostate Cancer conditions: Prostate Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Phase 2, single-arm study composed of 2 stages: in the first stage, 13 subjects diagnosed with mHSPC will be enrolled and treated with EPI-7386 in combination with enzalutamide. If there are 8 or less subjects with a biochemical response at 6 months, then the trial will be suspended. Otherwise, 22 additional subjects will be enrolled and treated. primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: EPI-7386 name: Enzalutamide name: Androgen Deprivation Therapy (ADT) measure: Biochemical response rate measure: PSA progesterone-free survival (PFS) measure: Radiographic PFS (rPFS) measure: ORR (confirmed) measure: AUC0-24 measure: Maximum concentration (Cmax) measure: Predose Plasma Concentration measure: Time to reach Cmax (Tmax) measure: Terminal elimination half-life measure: Volume of distribution at steady state after extravascular administration measure: Clearance after extravascular administration measure: Treatment-emergent adverse events measure: Rate of abnormalities in clinical laboratory parameters measure: Rate of abnormalities in vital sign measurements measure: Rate of bnormalities in electrocardiograms (ECGs) measure: Changes in Eastern Cooperative Oncology Group (ECOG) performance status sex: MALE minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals Cleveland Medical Center Seidman Cancer Center, Case Comprehensive Cancer Center city: Cleveland state: Ohio zip: 44106 country: United States name: Pedro Barata, MD, MSc role: CONTACT phone: 216-262-1214 email: Pedro.Barata@UHhospitals.org lat: 41.4995 lon: -81.69541 facility: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center city: Cleveland state: Ohio zip: 44195 country: United States name: Christopher Wee, MD role: CONTACT phone: 866-223-8100 email: TaussigResearch@ccf.org lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06312657 id: 81971 briefTitle: Behavioral Effects of Drugs Inpatient 44 Neurobehavioral Mechanisms of Opioid Choice acronym: BED(In)(44) overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-03-28 date: 2026-03-28 date: 2024-03-15 date: 2024-04-17 name: Joshua A. Lile, Ph.D. class: OTHER briefSummary: The objective of this protocol is to use probabilistic choice tasks, reinforcement learning modeling and fMRI to determine the neurobehavioral mechanisms of decision-making in individuals with opioid use disorder and physical opioid dependence. conditions: Opioid Use Disorder studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 18 type: ESTIMATED name: Drug Cue name: Money name: Withdrawal measure: Task choices sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06312644 id: D9289C00007 briefTitle: Study of Ultomiris® (Ravulizumab) Safety in Pregnancy overallStatus: NOT_YET_RECRUITING date: 2024-03-29 date: 2033-10-21 date: 2033-10-21 date: 2024-03-15 date: 2024-03-15 name: Alexion Pharmaceuticals, Inc. class: INDUSTRY briefSummary: The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of selected fetal/neonatal/infant outcomes in utero, at birth, and through 1 year of age after exposure in utero or via breastmilk. conditions: Ultomiris-exposed Pregnant/ Postpartum conditions: Pregnancy conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH) conditions: Atypical Hemolytic Uremic Syndrome (aHUS) conditions: Generalized Myasthenia Gravis (gMG) conditions: Neuromyelitis Optica Spectrum Disorder (NMOSD) studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 300 type: ESTIMATED name: Ultomiris measure: Number of Pregnancy Complications measure: Number of Maternal Complications measure: Fetal/Infant Outcomes sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06312631 id: RC31/21/0342 briefTitle: Home Grip Assistance Glove on the Use of the Upper Limb and Compliance Factors in Brain-injured Adults acronym: ECO-HAND-AVC overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-15 date: 2024-03-15 name: University Hospital, Toulouse class: OTHER briefSummary: On a functional level, performing the actions of daily life requires coordinated activity of the muscles of the upper limbs. The quality of motor recovery and/or technical assistance aimed at compensating for the movement deficit of the paretic upper limb (MSP) determines the possibilities of using the upper limb (MS) in activities of daily life.

Interventions in the chronic phase of stroke aim to return home. The integration of the paretic upper limb into daily life activities is a major issue regarding the prognosis of recovery of use of the upper limb. Independence in daily life becomes an ultimate goal to take charge of.

Our study focuses on a new technical aid device, standard orthosis type, expanding the range of gripping gloves: the SaeboGlove in everyday environments. These MS orthoses help improve the use and function of the MSP in post-stroke adults as well as their independence and participation in society. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 100 type: ESTIMATED name: Putting on the gripping glove name: ULPA questionnaire name: Motor Activity Log (MAL) Questionnaire name: Fugl-Meyer Assessment Upper Extremity (FMA-UE) questionnaire name: Score Action Arm Research Test name: EuroQol five-level (EQ-5D-5L) questionnaire name: Quebec User Evaluation of Satisfaction with Assistive Technology name: Psychosocial Impact of Assistive Devices Scale (PIADS) name: Goal Attainment Scale (GAS) name: installation and collection of accelerometers measure: Evaluation of the effectiveness of the gripping glove measure: Evaluation of the performance of an activity in the real context of the patient measure: Evaluation of factual spontaneous use of the upper limb in daily life measure: Evaluation of the perceived performance of the use of the paretic upper limb measure: Assessment of the quality of voluntary motor skills of the upper limb measure: Assessment of gripping abilities measure: Quality of life assessment measure: Evaluation of satisfaction and tolerance measure: Evaluation of the psycho-social impact sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Claire VILLEPINTE city: Toulouse state: CHU De Toulouse zip: 31059 country: France name: Claire VILLEPINTE role: CONTACT phone: 5 67 77 17 24 phoneExt: +33 email: villepinte.c@chu-toulouse.fr name: Audrey TOMASIK role: CONTACT phone: 561778597 phoneExt: +33 email: tomasik.a@chu-toulouse.fr lat: 43.60426 lon: 1.44367 hasResults: False

 nctId: NCT06312618 id: FMASU MD292/2023 briefTitle: Propofol Versus Dexmedetomidine Effect on Prevention Emergence Agitation overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-09-15 date: 2024-10-15 date: 2024-03-15 date: 2024-03-15 name: Ain Shams University class: OTHER briefSummary: The goal of this clinical trial is to compare Propofol versus Dexmedetomidine in children undergoing squint surgery. The main question it aims to answer is:

• Which drug is more effective in preventing the appearance of Emergence Agitation in children after sevoflurane anesthesia in squint surgery, propofol or dexmedetomidine?

Emergence agitation (EA) is a period of restlessness, agitation, inconsolable crying, disorientation, delusions, and hallucinations with impaired cognition and memory that commonly occurs in children undergoing ophthalmic surgery especially after Short acting volatile agents such as sevoflurane. conditions: Emergence Agitation studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 30 type: ESTIMATED name: Propofol name: Dexmedetomidine measure: the overall incidence of postoperative Emergence Agitation measure: Vital signs change. measure: Vital signs change. measure: Vital signs change. measure: Proportion of patients with adverse events in the PACU measure: Proportion of patients with Post Operative Nausea and Vomiting (PONV) sex: ALL minimumAge: 3 Years maximumAge: 7 Years stdAges: CHILD hasResults: False

 nctId: NCT06312605 id: 230620 briefTitle: The Adjunctive Role of Vitamin C on Pigment Recurrence (Randomized Clinical and Histological Trial) overallStatus: RECRUITING date: 2023-08-01 date: 2024-08 date: 2024-08 date: 2024-03-15 date: 2024-03-15 name: Ain Shams University class: OTHER briefSummary: The goal of this clinical trial is to determine the role of vitamin C on recurrence of gingival pigment after patients who are healthy and esthetically concerned with it received surgical removal of this pigment. The main question\[s\] it aims to answer are:

* Pigment recurrence after one year.
* Patient satisfaction and histological response of tissues.

Participants will be asked to come on regular follow up visits one group will receive vitamin C injection other will be asked to apply topical vitamin C on a specific regimen.

Researcher will compare the groups who received injectable vitamin C with those who topically applied it to see the effect of each. conditions: Gingival Pigmentation studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: All participants receive surgical depigmentation then either vitamin C is applied following 2 regimens primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Coding of the groups whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Injectable applied vitamin C name: Topical applied Vitamin C name: Surgical depigmentation only measure: Pigmentation scores measure: Assessment of pigment surface area (SA) measure: Assessment of pigment intensity in terms of mean darkness value (MDV) measure: Patient satisfaction measure: Histological response sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Faculty AinShams University status: RECRUITING city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06312592 id: FWA00015367 briefTitle: GBV Prevention, Mitigation, and Response in Colombia overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-11 date: 2025-03-30 date: 2025-09-01 date: 2024-03-15 date: 2024-04-19 name: Washington University School of Medicine class: OTHER name: Universidad de Los Andes briefSummary: As of August 2021, Colombia hosts the vast majority of Venezuelan refugees and migrants (UNHCR, 2022). For vulnerable refugees and migrants in Colombia, and especially for women, gender-based violence (GBV) is present during transit and continues in their new homes where xenophobia, lack of accessible and adequate services, lack of safe economic opportunities, and lack of information on access to services, further increase risk. Lack of livelihood opportunities also affect vulnerable refugees and migrants, especially women, with barriers to employment including lack of information; precarious working conditions with lower payments and longer working days with increasing risks of labor exploitation; xenophobia and discrimination; limited access to formal labor markets; lack of access to financial services, among others. To address these issues, the investigators are conducting a pilot randomized-controlled trial (RCT) of HIAS' Entrepreneurship School with Gender Lens (ESGL), a methodology that targets GBV survivors and women at-risk to help them develop business ideas, access needed support for the prevention of and response to GBV, exploitation and trafficking, and improve participants' overall self-reliance. The pilot RCT will be conducted within three cities in Colombia; approximately 80 eligible participants will be enrolled in each city and randomized to a treatment or control arm. Survey questionnaires will be administered to participants at baseline, eight months following baseline (endline), and 3-4 months after endline. Outcomes of interest include household self-reliance, mental health, empowerment, decision-making, and GBV risk and knowledge. conditions: Refugee Self-reliance conditions: Mental Health Issue conditions: Empowerment conditions: Gender Based Violence Knowledge and Perceived Risk conditions: Decision Making studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 253 type: ACTUAL name: Entrepreneurship School with Gender Lens measure: Self-Reliance Index measure: Patient Health Questionnaire (PHQ-9) measure: Brief Scale of Resilient Strategies measure: Multidimensional Women's Empowerment Index measure: GBV perceived risk sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Los Andes University city: Bogotá country: Colombia lat: 4.60971 lon: -74.08175 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-27 uploadDate: 2024-03-08T15:46 filename: ICF_000.pdf size: 255505 hasResults: False

 nctId: NCT06312579 id: E4897-P briefTitle: At-Home Exercise Study for Veterans With Healed Diabetic Foot Ulcers overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2026-03-31 date: 2026-03-31 date: 2024-03-15 date: 2024-03-15 name: VA Office of Research and Development class: FED briefSummary: Foot ulcers and amputations are a common and feared complication for people with diabetes. People with a diabetic foot ulcer have a higher risk of dying within five years than people with diabetes without an ulcer. At least one in four people with a new diabetic foot ulcer will die within five years, largely due to cardiovascular causes. The reasons for this increased mortality involve decreased mobility.

People with a recently healed diabetic foot ulcer are considered "in remission" as opposed to "cured" because the underlying medical problems which led to their ulcer are still present. Once in remission, the current standard of care is to slowly increase ambulation. The problem is that people rarely return to the recommended level of mobility. The ability to safely maintain mobility with aging is critical.

This pilot study is a small clinical trial to test the feasibility and acceptability of a home-based exercise regimen. The investigators will also assess if this home-based exercise regimen can increase mobility and function without increasing diabetic foot ulcer recurrence by improving lower extremity strength, lower extremity tissue perfusion and glycemic control. conditions: Diabetic Foot Ulcer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a single center, randomized, outcome assessor blinded, parallel group clinical trial comparing a 12-week exercise regimen to standard of care. primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 25 type: ESTIMATED name: 12-week home based exercise name: 12-week standard of care measure: Gait speed measure: Feasibility- Recruitment measure: Physical Activity measure: Acceptability- Usage Rating Profile-Intervention measure: Muscular strength measure: Perfusion measure: Glycemic control measure: Mobility measure: Acceptability measure: Adherence to the exercise regimen measure: Feasibility- Retention measure: Community mobility sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD city: Baltimore state: Maryland zip: 21201 country: United States name: Frederick M Ivey, PhD role: CONTACT phone: 410-605-7000 phoneExt: 56510 email: Frederick.Ivey@va.gov name: Mary-Claire Roghmann, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06312566 id: EP0231 briefTitle: A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Japanese Male Study Participants overallStatus: RECRUITING date: 2024-03-25 date: 2024-10-25 date: 2024-10-25 date: 2024-03-15 date: 2024-04-24 name: UCB Biopharma SRL class: INDUSTRY briefSummary: The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV dry syrup after multiple oral doses in healthy male Japanese participants. conditions: Healthy Study Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 96 type: ESTIMATED name: brivaracetam (BRV) tablet name: brivaracetam (BRV) dry syrup measure: Maximum plasma concentration at steady state [Cmax(ss)] after multiple doses of brivaracetam measure: Area under the curve during a dosing interval at steady state [AUC(tau)] after multiple doses of brivaracetam measure: Percentage of study participants with treatment-emergent adverse events (TEAEs) measure: Percentage of study participants with serious treatment-emergent adverse events (serious TEAEs) measure: Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation sex: MALE minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Ep0231 001 status: RECRUITING city: Sumida- Ku state: Tokyo country: Japan hasResults: False

 nctId: NCT06312553 id: IRB-300012515 id: P50MD017338 type: NIH link: https://reporter.nih.gov/quickSearch/P50MD017338 briefTitle: Remotely Delivered Mindfulness-Based Diabetes Education overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-03-31 date: 2026-06-30 date: 2024-03-15 date: 2024-03-18 name: University of Alabama at Birmingham class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: Diabetes distress is common affecting over one-third of people with type 2 diabetes, negatively impacting self-management and outcomes, and disproportionately affecting low-income individuals. The proposed project will conduct a pilot randomized controlled trial comparing remotely delivered Mindfulness-Based Diabetes Education plus remote patient monitoring of blood glucose to standard Diabetes Self-Management Education in rural Black adults with type 2 diabetes and elevated diabetes distress who receive care within federally qualified health centers to assess feasibility and acceptability. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Remotely delivered Mindfulness-Based Diabetes Education with remote patient monitoring name: Standard Diabetes Self Management Education measure: Feasibility: percentage of screened participants who are eligible measure: Feasibility: percentage of eligible participants who enroll measure: Feasibility: ability to randomize participants to study arms measure: Feasibility: distribution of participants by demographics measure: Feasibility: percentage of sessions attended measure: Feasibility: participant adherence to study tasks include home mindfulness practices, self-monitoring activities. measure: Feasibility: barriers to participation in intervention sessions or completing study activities at home measure: Feasibility: reasons for dropping out measure: Feasibility: overall study retention measure: Acceptability sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06312540 id: PERSONA id: 15397/2018 type: OTHER_GRANT domain: Tuscany Region - Bando FAS briefTitle: PERSonalized rObotic NeurorehAbilitation for Stroke Survivors acronym: PERSONA overallStatus: RECRUITING date: 2020-09-02 date: 2024-04-01 date: 2024-09-01 date: 2024-03-15 date: 2024-03-15 name: Azienda Ospedaliero, Universitaria Pisana class: OTHER name: Fondazione Don Carlo Gnocchi Onlus name: Scuola Superiore Sant'Anna di Pisa briefSummary: The aim is to carry out a first clinical study, to expand existing knowledge about the neurophysiological mechanisms underlying post-stroke recovery. The information acquired during this phase will be used as building blocks to develop customized protocols. Understanding the mechanisms underlying stroke-induced motor deficits and motor recovery is mandatory to improve clinicians; ability to guide the repair of the affected neural structures. The motor system comprises a network of cortical and subcortical areas interacting via excitatory and inhibitory circuits, thereby governing motor behaviour. Stroke lesions cause neural dysfunction both at the lesion site and in remote brain regions. Abnormal interactions among cortical regions within the motor network contribute to the motor impairment after stroke. Longitudinal analysis of neural activity and connectivity can help to understand the pathophysiology mechanisms underlying functional impairment and recovery after stroke. Analysis of the data will try to extract biomarkers of plasticity and recovery that will be used to design customized therapeutic interventions. conditions: Stroke Acute studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Brain activity measure: Functional evaluation measure: Clinical scale measure: Spasticity assessment sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AOUPisana status: RECRUITING city: Pisa state: Pi zip: 56124 country: Italy name: Stefania Dalise, Medical role: CONTACT phone: 001 050 994282 email: stefania.dalise@ao-pisa.toscana.it name: Stefania Dalise, Medical role: SUB_INVESTIGATOR lat: 43.70853 lon: 10.4036 hasResults: False

 nctId: NCT06312527 id: TUH Mepiform TKA briefTitle: Mepiform in Simultaneous Bilateral TKA overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-07 date: 2024-05-31 date: 2024-05-31 date: 2024-03-15 date: 2024-03-15 name: Thammasat University Hospital class: OTHER briefSummary: The goal of this RCT is comparing efficacy of silicone dressing in scar preventing after simultaneous bilateral total knee arthroplasty.

The main question\[s\] it aims to answer are:

* Does silicone dressing can prevent scar formation after total knee arthroplasty?
* Does silicone dressing have similar functional outcomes and complications after total knee arthroplasty? Participants will apply silicone dressing after wound healed and apply for 10 weeks. Researchers will compare to the other side that is no intervention. conditions: Scar Prevention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Silicone dressing measure: Vancouver Scar Scale measure: Range of motion measure: Forgotten joint score measure: modified WOMAC score measure: Scar pain measure: Scar itching measure: Complications sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thammasat University city: Khlong luang state: Pathum Thani zip: 12120 country: Thailand lat: 14.06467 lon: 100.64578 hasResults: False

 nctId: NCT06312514 id: STUDY00008615 id: R01NR021170 type: NIH link: https://reporter.nih.gov/quickSearch/R01NR021170 briefTitle: Lafiya HIV-status Neutral Study - Protocol overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2028-08-29 date: 2028-08-29 date: 2024-03-15 date: 2024-03-15 name: University of Rochester class: OTHER name: National Institute of Nursing Research (NINR) name: University of Ghana name: Yale University briefSummary: The primary objective of this study is to adapt and evaluate the feasibility of "Lafiya," which means "Wellness" in Hausa, a multilevel intersectional stigma \& discrimination (ISD) and HIV testing intervention, to a status-neutral intervention to increase HIV testing, PrEP, and ART Uptake (HPART) among young gay, bisexual, and other men who have sex with men in Ghanaian slums. Specific objectives include, Assessing intersectional stigma and options for HPART implementation, Adapting Lafiya to a status-neutral intervention to address intersectional stigma and increase HPART uptake among YGBMSM, Test acceptance, feasibility, appropriateness, and preliminary efficacy of Lafiya to address intersectional stigma and increase HIVST uptake. conditions: HIV Prevention and Care studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: intervention and waitlist control groups primaryPurpose: PREVENTION masking: NONE maskingDescription: None (Open Label) count: 1193 type: ESTIMATED name: LAFIYA measure: Change in HIV testing. measure: Change in PrEP Adherence. measure: Change in ART Adherence measure: Change in Treatment Self-Efficacy. measure: Percentage change in HIV stigmatizing attitudes. measure: Percentage change in reported sexual behavior stigma. measure: Percentage change in gender nonconformity stigma measure: Percentage change in PrEP-related stigma measure: Neighborhood stigma measure: Mean change in the Basic Needs Satisfaction measure: Percentage of participants that reported healthcare climate stigma. measure: Percentage of participants that reported Brief Resilience measure: Changes in Healthcare facility Intersectional stigma and discrimination. sex: MALE minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: University of Ghana city: Accra country: Ghana lat: 5.55602 lon: -0.1969 hasResults: False

 nctId: NCT06312501 id: 2021-0020 TELESAT briefTitle: Remote Patient Monitoring for Patients With Heart Failure in France acronym: TELESAT overallStatus: COMPLETED date: 2018-08-01 date: 2021-12-31 date: 2022-12-31 date: 2024-03-15 date: 2024-03-15 name: Satelia class: INDUSTRY briefSummary: The goal of this multicenter observational longitudinal cohort study is to evaluate the ability of a Remote Patient Monitoring (RPM) program to prevent cardiac decompensation by detecting weak signals of decompensation early in patients with chronic heart failure in France.

The main question it aims to answer is whether an RPM solution can provide the improvement in overall patient survival

Participants will answer to questionnaires provided by the RPM solution for the follow-up of their condition.

Researchers will compare the following cohorts to see if RPM can improve their condition:

* Cohort 1: using RPM for follow-ups.
* Cohort 2: conventional care and not using any devices and solutions for the follow-ups. conditions: Heart Failure conditions: Patient Empowerment conditions: Cardiac Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 20000 type: ACTUAL name: Satelia®Cardio name: Conventional care measure: Number of All Causes Deaths measure: Number of unplanned heart failure Hospitalization measure: Number of All Causes Deaths in elderly patients measure: Number of unplanned hospitalization for heart failure in elderly patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NP Medical city: Bordeaux zip: 33000 country: France lat: 44.84044 lon: -0.5805 hasResults: False

 nctId: NCT06312488 id: 4097 briefTitle: Point of Care Evaluation of Fibrinolysis in Sepsis acronym: POCEFIS overallStatus: RECRUITING date: 2024-01-22 date: 2025-03-31 date: 2025-08-31 date: 2024-03-15 date: 2024-03-15 name: Policlinico Hospital class: OTHER briefSummary: Impaired fibrinolysis in septic patients is associated with worse outcome. The present study investigates fibrinolysis shutdown in septic patients, defined as prolonged ClotPro® TPA lysis time at 30 minutes. The TPA lysis time reference range is established in a cohort of healthy volunteers. conditions: Fibrinolytic Defect conditions: Sepsis conditions: Critical Illness studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: Clot Pro measure: Prevalence of impaired fibrinolysis measure: Correlation between impaired fibrinolysis and changes in coagulation standard tests measure: Correlation between impaired fibrinolysis and inflammation markers measure: Correlation between impaired fibrinolysis and multiorgan failure measure: Correlation between impaired fibrinolysis and ICU lenght of stay measure: Correlation between impaired fibrinolysis and ICU mortality measure: Trend of fibrinolysis in the first ICU week with repeated ClotPro® tests sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: RECRUITING city: Milan state: MI zip: 20100 country: Italy name: Mauro Panigada, MD role: CONTACT phone: 02 5503 3258 email: mauro.panigada@policlinico.mi.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06312475 id: KN057-A-301 briefTitle: Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B With Inhibitors overallStatus: RECRUITING date: 2024-01-09 date: 2025-10-15 date: 2025-12-15 date: 2024-03-15 date: 2024-03-15 name: Suzhou Alphamab Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to show that KN057 can prevent bleeds in patients with haemophilia A or B with inhibitors and is safe to use. Successfully screened participants will be randomly assigned to KN057 Prophylaxis (Arm 1) versus No Prophylaxis (Arm 2) at a ratio of 2:1. Participants in KN057 Prophylaxis will receive KN057 prophylaxis for 52 weeks upon enrollment. Participants in No Prophylaxis will first receive on-demand treatment for 26 weeks, then switch to KN057 prophylaxis for 26 weeks.The trial period is 59 weeks, including a 3-week screening period, a 26-week main trial, a 26-week extension period, and a 4-week follow-up period after the last administration. conditions: Hemophilia A With Inhibitor conditions: Hemophilia B With Inhibitor studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 51 type: ESTIMATED name: KN057 measure: Annualized bleeding rate (ABR) calculated based on treated spontaneous and traumatic bleeding episodes in Arm 1 and Arm 2. measure: ABR calculated based on bleeding episodes, treated spontaneous bleeding episodes, treated joint bleeding episodes, and treated target joint bleeding respectively in Arm 1 and Arm 2. measure: ABR calculated based on bleeding episodes and treated bleeding episodes respectively in Arm 2. measure: ABR calculated based on bleeding episodes, treated bleeding episodes, treated spontaneous bleeding episodes, treated joint bleeding episodes, and treated target joint bleeding respectively in Arm 1. measure: Change from baseline in Hemophilia Joint Health Score (HJHS) scores in Arm 1 and Arm 2. measure: Change in HJHS scores from baseline in Arm 1 and from the 26th week in Arm 2. measure: Change from baseline in EuroQol 5 Dimensions 5 Level (EQ-5D-5L) in Arm 1 and Arm 2. measure: Change in EQ-5D-5L from baseline in Arm 1 and from the 26th week in Arm 2. measure: Incidence of TEAE, TEAE related to the experimental drug and SAE. measure: Incidence of thromboembolic events, TMA and DIC. measure: Incidence of hypersensitivity type reactions. measure: Incidence of injection site reactions. measure: Incidence of clinically significant laboratory value abnormalities. measure: Number of participants with clinically significant changes from baseline in physical exam. measure: Number of participants with clinically significant changes from baseline in electrocardiograms. measure: Number of participants with clinically significant changes from baseline in vital signs. measure: KN057 plasma trough concentration. measure: Levels of Free TFPI. measure: Levels of prothrombin fragment 1+2 (PF1+2). measure: Incidence of anti-KN057 antibody (ADA) and neutralizing antibody (Nab). sex: MALE minimumAge: 12 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences status: RECRUITING city: Tianjin state: Tianjin zip: 300020 country: China name: Renchi Yang, Doctor role: CONTACT lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06312462 id: PembaMoH briefTitle: Health Education Model Led by Community Health Volunteers. overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2025-02 date: 2025-05 date: 2024-03-15 date: 2024-03-15 name: Pemba Ministry of Health Zanzibar class: OTHER briefSummary: The goal of this intervention study is to investigate the level of knowledge, attitudes, and behaviors of students on schistosomiasis in Pemba Island. It aims to test the effectiveness of establishing a widely applicable Community Health Volunteers model in the Zanzibar region and explore the feasibility of promoting this model in other areas of Africa. This study also aims to provide valuable insights and references for global schistosomiasis prevention and control efforts. conditions: Schistosomiasis conditions: Health Education studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This model evaluates the effectiveness of schistosomiasis health education led by community health volunteers by training the volunteers on Pemba Island and having them conduct health education for local students. It also discusses the feasibility of promoting this model in Africa. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 400 type: ESTIMATED name: health education measure: change in infection rate measure: Change in Knowledge Level measure: Attitudes Changes measure: Behaviors Changes measure: Student satisfaction survey sex: ALL minimumAge: 7 Years maximumAge: 15 Years stdAges: CHILD facility: Neglected tropical diseases in Pemba city: Pemba state: CharkChark zip: P.O.BOX 98 country: Tanzania hasResults: False

 nctId: NCT06312449 id: 2211110001 briefTitle: Effect of Peanut Balls Used of the Second Stage of Labor, Pushing Perceptions, Fatigue and Birth Outcomes overallStatus: COMPLETED date: 2023-03-01 date: 2023-09-20 date: 2023-09-23 date: 2024-03-15 date: 2024-03-15 name: Tung Yu-Ching class: OTHER name: Chang Gung Memorial Hospital briefSummary: This study aims to explore the use of peanut balls during the second stage of labor. It compares three different positions: traditional lithotomy position, lateral position, and lateral position with peanut ball in terms of women's perceived pushing effort experiences, fatigue, and birth outcomes. conditions: Other studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 162 type: ACTUAL name: The side-lying position with the peanut ball during the second stage of labor. name: During the second stage, the patient is placed in a lateral position measure: The duration of the second stage of labor of women who use side-lying with peanut balls. measure: The pushing time of women in the second stage of labor who use side-lying with peanut balls. measure: lateral position with peanut ball in terms of women's perceived pushing effort experiences. measure: Parturients using the side-lying position with a peanut ball for experience levels of fatigue. sex: FEMALE minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yu-Ching Tung city: Taoyuan City country: Taiwan lat: 24.95233 lon: 121.20193 hasResults: False

 nctId: NCT06312436 id: AT-REBOA briefTitle: The AT-REBOA Target Trial acronym: AT-REBOA overallStatus: ACTIVE_NOT_RECRUITING date: 2019-01-01 date: 2023-10-01 date: 2024-03 date: 2024-03-15 date: 2024-03-15 name: Medical University of Graz class: OTHER briefSummary: Temporary aortic occlusion can limit haemorrhage, can help to maintain perfusion to the heart and brain, and may be associated with improved survival. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) potentially provides a relatively quick means of achieving this temporary control.

In the past years, studies have tried to evaluate the benefit for this method with conflicting results. The previous UK-REBOA trial has not found any benefit in the intervention group and has even hinted at possible harm caused by the intervention. A major limitation of this study is the low number of interventions performed in participating trauma centres and the associated potentially insufficient experience with REBOA.

The aim of this study is to evaluate the effectiveness of REBOA in a setting with already experienced providers. conditions: Hemorrhage conditions: Shock, Traumatic conditions: Cardiac Arrest Due to Trauma conditions: Polytrauma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 44 type: ACTUAL name: Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) measure: 30-day in-hospital mortality measure: 3-hour mortality measure: 6-hour mortality measure: 24-hour mortality measure: 90-day mortality measure: Intensive Care Unit length of stay measure: Hospital length of stay measure: Blood product use measure: Use of whole body computed tomography measure: damage control procedure performed measure: Time to damage control procedure measure: Rate of complications measure: Cause of death sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Centre Graz city: Graz state: Styria zip: 8036 country: Austria lat: 47.06667 lon: 15.45 facility: Center for Medical Data Science city: Vienna zip: 1090 country: Austria lat: 48.20849 lon: 16.37208 hasResults: False

 nctId: NCT06312423 id: ECDA000/02 briefTitle: Safety and Pharmacokinetics of IMT504, an Immunomodulator and Tissue Repair Inducer acronym: ECDA000/02 overallStatus: RECRUITING date: 2024-02-23 date: 2024-08-30 date: 2024-12-30 date: 2024-03-15 date: 2024-03-15 name: Ministry of Public Health of the Province of La Rioja class: OTHER_GOV name: Immunalgia Therapeutics S.A. briefSummary: Phase 1 open-label dose-escalation study to evaluate the safety and pharmacokinetics of IMT504 Phosphorothioate Oligonucleotide, an immunomodulator and tissue repair inducer, in healthy volunteers. conditions: Immune System studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: A total of 12 healthy adult volunteers of both sexes will be included, who will be progressively incorporated into 3 groups of 4 volunteers each. All volunteers will be evaluated at a research site authorized by the Regulatory Authority (ANMAT) to conduct phase 1 studies. primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Oligonucleotides, Phosphorothioate measure: Safety: Local and systemic reaction after administration of each dose of the investigational drug measure: Safety: Serious adverse event measure: Safety: Variations in the Laboratory results measure: Pharmacokinetics: IMT504 level in Serum measure: Pharmacokinetics: IMT504 level in Serum measure: Pharmacokinetics: IMT504 level in Serum measure: Pharmacokinetics: IMT504 level in Serum measure: Pharmacokinetics: IMT504 level in Serum measure: Pharmacodynamics: Interleukin - 35 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CENTRO DE INVESTIGACIÓN PARA ESTUDIOS DE FARMACOLOGÍA CLÍNICA DE FASE1 EN POBLACIÓN ADULTA y DE BIOEQUIVALENCIA. Sanatorio Nuestra Señora del Pilar status: RECRUITING city: Buenos Aires zip: 1702 country: Argentina name: Eduardo Pirotzky, Doctor role: CONTACT phone: 541144696700 email: epirotzky@yahoo.com lat: -34.61315 lon: -58.37723 hasResults: False

 nctId: NCT06312410 id: H-23067714 briefTitle: The VIA Family 2.0 - a Family Based Intervention for Families With Parental Mental Illness overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2027-12-31 date: 2028-12-31 date: 2024-03-15 date: 2024-03-15 name: Mental Health Services in the Capital Region, Denmark class: OTHER name: Aalborg Psychiatric Hospital name: TrygFonden, Denmark name: Novo Nordisk A/S name: Lundbeck Foundation name: Liljeborgfonden name: Ebbefos Fonden name: KV Fonden briefSummary: VIA Family 2.0 - a Family Based Intervention for families with parental mental illness

Background: Children born to parents with mental illness have consistently been shown to have increased risks for a range of negative life outcomes including increased frequencies of mental disorders, somatic disorders, poorer cognitive functioning, social, emotional and behavioral problems and lower quality of life. Further these children are often overlooked by both society and mental health services, although they represent a potential for prevention and early intervention.

A collaboration between researchers and clinicians from two regions, the Capital Region and the North Region Denmark has been established as the Research Center for Family Based Interventions. The research center is an umbrella for a series of research activities, all focusing on children and adolescents in families with parental mental illness.

Method: A large randomized, controlled trial (RCT) for families with parental mental illness will be conducted in order to evaluate the effect of a two-year multidisciplinary, holistic team intervention (the VIA Family 2.0 team intervention) against treatment as usual (TAU). Inclusion criteria will be biological children 0-17 of parents with any mental disorder treated in the secondary sector at any time of their life and receiving treatment in primary or secondary sector within the previous three years. A total of 870 children or approx. 600 families will be included from two sites. Primary outcomes will be changes in child well being, parental stress, family functioning and quality of the home environment, .

Time plan: The RCT will start including families from March 1st, 2024 to Dec 2025 (or later if needed). All families will be assessed at baseline and at end of treatment, i.e. after 24 months and after 36 months. Baseline data will inform the intervention team about each family's needs, problems, and motivation. TAU will be similar in the two regions, which means three family meetings and option for children to participate in peer groups.

Challenges: final funding is being applied for. Recruitment of families can be challenging but we have decades of experience in conducting research in the field. Since both the target group, their potential problems and the intervention is complex, primary outcome is difficult to determine. conditions: Child conditions: Parents conditions: Mental Disorder conditions: Child of Impaired Parents conditions: Preventive Health Services studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1452 type: ESTIMATED name: VIA Family 2.0 measure: Change in Strengths and Difficulties Questionnaire (SDQ) measure: Change in Bayley-4 Bayley Scales Test for Infant and Toddler Development measure: Change in Family Assessment Device - General Function Scale (FAD-GF) measure: Change in Parental Stress Scale (PSS) measure: Change in Home Observation for Measurement of the Environment (HOME) measure: Change in Parenting and Family Adjustment Scales (PAFAS) measure: Change in Children's Global Assessment Scale (CGAS) measure: Change in Perceived Stress Scale (PSS) measure: Client Satisfaction Scale (CSQ) measure: Change in Vineland Adaptive Behavior Scales-Second Edition (Vineland-II) measure: Change in children's quality of life (KIDSCREEN-27) measure: Change in Ages and Stages Questionnaire:SE-2 (ASQ-SE) measure: Change in Daily Life Stressor Scale (DLSS) measure: Change in Child and Youth Resilience Measure (CYRM-R) measure: Alarm Distress Baby Scale (ADBB) measure: Change in Personal and Social Performance Scale (PSP) measure: Change in Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) measure: Change in Global Assessment of Function - Symptoms (GAF-S) measure: Change in Kessler Psychological Distress Scale, K10 measure: Change in General Self-Efficacy Scale (GSE) measure: Change in Social Provision Scale-short form (SPS) measure: Change in Quality-adjusted life year (EQ-5D) measure: Change in Self-Stigma of Mental Illness Scale - short form (SSMIS-SF) measure: Change in The Questionnaire about the Process of Recovery (QPR) sex: ALL minimumAge: 0 Years maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06312397 id: MU-HF-BVD-01 briefTitle: The Effect on Back Pain and Fatigue Level of Acupressure overallStatus: RECRUITING date: 2024-03-04 date: 2024-07-30 date: 2024-08-30 date: 2024-03-15 date: 2024-03-15 name: Mersin University class: OTHER briefSummary: This research was conducted with the aim of determining the effect of acupressure on the level of back pain and fatigue after coronary angiography. conditions: Coronary Angiography studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Three groups ( acupressure group, sham acupressure group and control group) primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Patients in the acupressure and sham acupressure groups were blinded as to which groups they were in. whoMasked: PARTICIPANT count: 120 type: ESTIMATED name: Acupressure name: Sham acupressure measure: Visual Analog Scale for Pain measure: Visual Analog Scale for Fatigue sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Birgül VURAL DOĞRU status: RECRUITING city: Mersin zip: 33110 country: Turkey name: Birgül VURAL DOĞRU, Associate Professor role: CONTACT phone: 03243610001 email: bvuraldogru@gmail.com lat: 36.79526 lon: 34.61792 hasResults: False

 nctId: NCT06312384 id: A04080622 briefTitle: The Influence of 3D Surgical Template on the Contour of Bone Augmentation, in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation overallStatus: ACTIVE_NOT_RECRUITING date: 2022-07-01 date: 2024-05 date: 2024-06 date: 2024-03-15 date: 2024-03-15 name: Mansoura University class: OTHER briefSummary: Evaluate the impact of using 3D surgical template with guided bone regeneration technique on the contour of bone augmentation in patients with horizontal labial ridge defect and simultaneous implantation. conditions: Bone Deformity studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group 1 \[Control group\]:

The defected site will be grafted with sticky bone (particulate bone substitute mixed with injectable platelet-rich fibrin (i-PRF)) and will be covered with collagen membrane will be applied \[conventional GTR\].

Group 2 \[Study group\]:

The defected site will be grafted with sticky bone (particulate bone substitute mixed with injectable platelet-rich fibrin (i-PRF)) and will be covered with collagen membrane will be applied, in this group 3D surgical template will be applied. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: each patient will be couded and only the princeiple investigator is the only person how know the type of intervantion whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: 3D Surgical Template on the Contour of Bone Augmentation, in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation name: conventional guided bone regeneration,in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation measure: Change in Radiographic assessment for all patients underwent Cone beam computed tomography (CBCT) scans sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Dentistry-Mansoura University city: Mansoura zip: 35516 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06312371 id: Feeding Hesitancy briefTitle: Intermittent Oro-esophageal Tube on Feeding Hesitancy in Stroke Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-15 date: 2024-03-15 name: Muhammad class: OTHER briefSummary: The aim of this clinical trial is to compare Feeding Hesitancy of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Feeding Hesitancy of the two groups. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding measure: Swallowing Quality of Life questionnaire sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06312358 id: IRB00408654 briefTitle: Expanding the Infant Achievements Intervention Through Community Partnerships overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06-30 date: 2024-07 date: 2024-03-15 date: 2024-03-15 name: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. class: OTHER name: Johns Hopkins University briefSummary: The goal of the research study is to increase teachers' implementation of evidence-based practices in Early Head Start classrooms through the delivery of a professional development (PD) training intervention. The main questions that the study aims to answer are:

1. Does teacher participation in a PD intervention improve the use of evidence-based practices from pre- to posttest?
2. To what extent is the PD intervention feasible to implement in an established child care program?
3. To what extent is the PD program acceptable to teachers?

Participants will attend PD workshops and participate in content-related job-embedded coaching sessions during the implementation of the study. conditions: Child Development conditions: Infant Development conditions: Developmental Delay conditions: Language Development studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All participants will be assigned to the study intervention consisting of (1) a professional development workshop and (2) weekly job-embedded coaching sessions. primaryPurpose: PREVENTION masking: NONE count: 15 type: ESTIMATED name: Building Capacity for Infant Achievements in Child Care measure: Classroom Quality (as assessed by scores on the TPITOS) sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06312345 id: 2024.3.10-2024.5.1 briefTitle: Ciprofol Versus Propofol for Anesthesia Induction in Cardiac Surgery: A Randomized Double-blind Controlled Clinical Trial overallStatus: RECRUITING date: 2024-03-11 date: 2024-05-01 date: 2024-05-10 date: 2024-03-15 date: 2024-03-15 name: Le Yu class: OTHER briefSummary: Ciprofol, a novel intravenous general anesthetic with a chemical structure akin to propofol, boasts significantly enhanced potency. It offers a rapid onset, reduced incidence of injection pain, and minor impact on the cardiovascular system. However, clinical research regarding ciprofol's use for anesthesia induction in cardiac surgery remains limited. conditions: Anesthesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Drug: ciprofol injection measure: Mean arterial pressure measure: Mean arterial pressure measure: Mean arterial pressure measure: Mean arterial pressure measure: Heart beats measure: Heart beats measure: Heart beats measure: Heart beats measure: Oxygenation index measure: Oxygenation index measure: Injection pain sex: ALL minimumAge: 55 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai East Hospital of Tongji University status: RECRUITING city: Shanghai state: Shanghai zip: 200120 country: China name: Le Yu, MM role: CONTACT phone: 19921875120 email: 907084943@qq.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06312332 id: HUM00220089 id: 1R01HL163438-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R01HL163438-01A1 briefTitle: Michigan Emergency Department Improvement Collaborative (MEDIC) Alert; Pulmonary Embolism (PE) overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-01 date: 2026-08 date: 2026-08 date: 2024-03-15 date: 2024-04-26 name: University of Michigan class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: This study is a quality improvement project to evaluate health care management of pulmonary embolism (PE) patients. The researchers are testing an intervention to determine if it prevents unnecessary hospital admissions. conditions: Pulmonary Embolism studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: cluster-randomized stepped-wedge design with two or more sites assigned at each of four steps primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 14 type: ESTIMATED name: Pulmonary Embolism (PE) Care in Emergency Department (ED) measure: Change in proportion of patients discharged home from Emergency Department (ED) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Michigan Emergency Department Improvement Collaborative partners city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06312319 id: DF0001 briefTitle: Home-based Respiratory Training on Swallowing in Stroke overallStatus: RECRUITING date: 2023-08-20 date: 2024-03-20 date: 2024-06-20 date: 2024-03-15 date: 2024-03-18 name: Universidad de Granada class: OTHER briefSummary: The aim of this study is to evaluate the effects of a home-based respiratory muscle training on swallowing function in patients with chronic stroke. The patients will be included in a experimental or a control group. The patients in the experimental group will receive a home-based respiratory training using respiratory devices added to standard treatment, while the participants in the control group will only receive the standard treatment. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Respiratory training name: Orofacial exercises measure: Gugging Swallowing screen measure: Swallowing quality of life questionnaire measure: cough peak flow measure: Forced vital capacity measure: Forced expiratory volumen in the first second measure: FEV1/FVC ratio measure: Respiratory Pressure Meter sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Health Sciences status: RECRUITING city: Granada zip: 18016 country: Spain name: Irene Cabrera Martos role: CONTACT email: irenecm@ugr.es lat: 37.18817 lon: -3.60667 hasResults: False

 nctId: NCT06312306 id: TDCS vs pilates in stroke briefTitle: Transcranial Direct Current Stimulation vs Pilates Core Training in Stroke overallStatus: RECRUITING date: 2024-02-25 date: 2024-08 date: 2024-09 date: 2024-03-15 date: 2024-03-26 name: Cairo University class: OTHER briefSummary: The goal of this clinical trial is to compare the effects of transcranial direct current stimulation and pilates based core stability training on gait and balance in stroke patients. The main question\[s\] it aims to answer are:

* is there an effect of transcranial direct current stimulation and pilates based core training on gait and balance
* Is there a significant effect of tDCS over Pilates-based core training

Participants will be assigned to three groups:

* Group 1: will receive 18 sessions(3 sessions/week 20 minutes each) of anodal tDCS in addition to conventional physical therapy exercises
* Group 2: Will receive 18 Pilates exercise sessions over a period of 6 weeks (3 sessions / week) in addition to conventional physical therapy exercises.
* Group 3: Will receive conventional physiotherapy program

Researchers will compare the transcranial direct current stimulation group with the pilates exercise group to see if one of them is superior to the other on balance and gait. conditions: Stroke conditions: Cerebrovascular Accident studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: transcranial direct current stimulation name: Pilates based core training name: conventional physiotherapy program measure: Gait kinematics measure: The Biodex Balance System measure: Stroke Impact Scale (SIS) sex: ALL minimumAge: 50 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of physical therpay cairo university status: RECRUITING city: Dokki state: Giza zip: 12613 country: Egypt name: Amal Abdel-Baky, Professor role: CONTACT phone: +202 37617691 email: p.grad@pt.cu.edu.eg lat: 30.03823 lon: 31.2113 hasResults: False

 nctId: NCT06312293 id: STUDYAP0004 briefTitle: Comparison of Effectiveness In-ear and Behind-ear Vagus Nerve Stimulation overallStatus: COMPLETED date: 2023-09-15 date: 2023-12-01 date: 2023-12-30 date: 2024-03-15 date: 2024-03-15 name: Bahçeşehir University class: OTHER briefSummary: The use of vagus nerve stimulation (VSS), one of the examples of neuromodulation therapies, continues to increase in the medical field. Basically, invasive (iVSS) and transcutaneous VSS (tVSS) can be performed. tVSS is more preferred because of its advantages such as easy application, not requiring surgical procedure and having fewer side effects. VSS has long been an approved treatment modality in the treatment of epilepsy and refractory depression. tVSS can be administered from the auricular-auricular or posterior ear region. The vagus nerve (VS) belongs to the parasympathetic branch of the autonomic nervous system and has an effect on vital functions. There are also studies in the literature showing that VS stimulation reduces inflammation. In addition to this effect, the vagus nerve may also show analgesic activity through pain-related pathways. Due to its anti-inflammatory and analgesic effects, VSS has become a new treatment method in diseases in which various inflammatory processes are shown in the etiology such as inflammatory bowel diseases, musculoskeletal system diseases and central nervous system diseases. conditions: Vagus Nerve Stimulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 76 type: ACTUAL name: Transcutaneous Vagus Nerve Stimulation measure: Heart Rate Variability sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Igdir University city: Igdir state: Central zip: 76000 country: Turkey lat: 39.92371 lon: 44.045 hasResults: False

 nctId: NCT06312280 id: CE342/2023 briefTitle: Evaluation of Body Composition in Pediatric Patients With Overweight or Obesity acronym: OBIASITY overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-01 date: 2024-11-30 date: 2024-03-15 date: 2024-03-19 name: Azienda Ospedaliero Universitaria Maggiore della Carita class: OTHER briefSummary: In recent decades, the prevalence of obesity and overweight has dramatically increased globally, representing a serious problem for society and for the health system of many countries, estimating an impact of 2-8% on global health spending. Obesity and overweight represent a problem not only for adults but also for children and adolescents: the latest data from the WHO estimate that about 340 million children and adolescents between 5 and 19 years are overweight or obese, data that increase drastically since 1975 from 4% of boys to 18% in 2016. (World Health Organization (WHO). The reduction and prevention of overweight and obesity in childhood is one of the main missions of public health at the global level, both for short-term and long-term implications. Recently, the importance of bioprothesiometric analysis (BIA) in the clinical routine has been evaluated, as it allows an estimation of body composition that would not otherwise be provided by the growth curves and the calculation of the Body Mass Index (BMI). In this study the investigators want to evaluate, in addition to the classic clinical parameters, the body composition of patients evaluated by means of an impedance balance (named TANITA MC780 MA P). With this study the investigators aim to investigate possible clinical and body composition changes in children and adolescents suffering from overweight and obesity with the ultimate aim of reducing cardio-metabolic risk factors related to it.

The objective of the study is the assessment of body composition, as an indicator of accuracy of lean mass, but especially of fat mass, of pediatric patients who are overweight and obesity in order to carry out a more complete evaluation of the clinical-metabolic condition for the prevention of cardiovascular risk.

The secondary objective is to assess the dietary compliance of the patients being studied and the possible correlation with the body composition. conditions: Pediatric Obesity studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 70 type: ESTIMATED name: Mediterranean diet measure: Change in Body composition measure: Dietary compliance with questionnaires measure: Correlation between change in body composition (primary outcome) and dietary compliance (secondary outcome) sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: SCDU Pediatria, AOU Maggiore della Carità city: Novara zip: 28100 country: Italy name: Simonetta Bellone, MD role: CONTACT phone: +39-0321-660693 email: simonetta.bellone@med.uniupo.it lat: 45.44694 lon: 8.62118 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-10-23 uploadDate: 2024-03-13T05:14 filename: Prot_SAP_000.pdf size: 348071 hasResults: False

 nctId: NCT06312267 id: 1840655 briefTitle: Reducing Wound Infections Using Bioelectric Wound Dressings acronym: JumpStart overallStatus: RECRUITING date: 2024-03-04 date: 2024-12-01 date: 2025-03-01 date: 2024-03-15 date: 2024-03-15 name: AdventHealth class: OTHER briefSummary: The purpose of this study is to compare the outcomes of using Bioelectric wound dressing on the pre-operative wound site and post operatively and compared it outcomes to the standard of care chlorhexidine skin preparation. conditions: Surgical Site Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Total of 20 patients will be identified and divided in two groups (control and experimental group). 10 of the patients undergo surgery using current ERAS protocol standard of care skin cleaning preparation. The other 10 patients skin prep will be substituted with the Bioelectrical dressing preoperatively and post-operative. primaryPurpose: PREVENTION masking: NONE count: 20 type: ESTIMATED name: Bioelectric dressing measure: Quantitative bacterial count sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AdventHealth Celebration status: RECRUITING city: Kissimmee state: Florida zip: 34747 country: United States name: Petronio Martins, MHA role: CONTACT phone: 321-299-6655 email: Petronio.martins@AdventHealth.com name: Diana Paredes, BSN role: CONTACT phone: 407-535-1984 email: Diana.Paredes@AdventHealth.com lat: 28.30468 lon: -81.41667 hasResults: False

 nctId: NCT06312254 id: N-20230071 briefTitle: Pharmacological Modulation of Peripheral Nerve Excitability overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2025-08 date: 2024-03-15 date: 2024-03-15 name: Aalborg University class: OTHER briefSummary: The present project is a human experimental study. The aim is to assess the pharmacologically modulated excitability of peripheral sensory nerves with a human experimental model.

The study measures the excitability of peripheral sensory nerves before and after application of different topical drugs (lidocaine (5%), phenytoin (10%),mepyramine (2%) and placebo). conditions: Peripheral Neuropathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: Participant and investigator/project involved personal is blinded to which cream is applied. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: Topical lidocaine 5% name: Topical Phenytoin 10% name: Topical Mepyramine 2% name: Topical Placebo measure: Change in PTT-value sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Neuroplasticity and Pain city: Aalborg country: Denmark lat: 57.048 lon: 9.9187 hasResults: False

 nctId: NCT06312241 id: MCT-Silver BeWell briefTitle: Metacognitive Training-Silver BeWell in Older Adults overallStatus: RECRUITING date: 2024-02-21 date: 2025-08 date: 2025-12 date: 2024-03-15 date: 2024-03-15 name: Universitätsklinikum Hamburg-Eppendorf class: OTHER briefSummary: The present study seeks to examine the feasibility, acceptance and efficacy of Metacognitive Training-Silver (MCT-Silver) BeWell among older adults (ages 60 years and older) delivered in a community setting (e.g., social-psychiatric community center, nursing homes, etc.). conditions: Depressive Symptoms conditions: Well-Being, Psychological studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Metacognitive Training-Silver BeWell measure: Number of sessions attended measure: Participants' appraisal of the training measure: Negative effects questionnaire (NEQ) measure: Depression (Beck Depression Inventory - II) measure: Dysfunctional beliefs (18-item Dysfunctional Attitudes Scale) measure: Mental Well-Being (Warwick-Edinburgh Mental Well-being Scale) measure: Resilience (Resilience Scale) measure: Rumination (Ruminative Responses Scale) measure: Loneliness (UCLA Loneliness scale) measure: Self-rated health (EQ5D5L Visual Analog Scale ) measure: Session-specific effects sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Hamburg-Eppendorf status: RECRUITING city: Hamburg zip: 20246 country: Germany name: Brooke Viertel, PhD role: CONTACT phone: 040 7410 24014 email: b.viertel@uke.de lat: 53.57532 lon: 10.01534 hasResults: False

 nctId: NCT06312228 id: 2023/05 briefTitle: The Effect of the Helper Skin Tap Technique and Buzzy® During Vaccination overallStatus: COMPLETED date: 2023-05-01 date: 2023-10-02 date: 2023-10-02 date: 2024-03-15 date: 2024-03-15 name: Tarsus University class: OTHER briefSummary: Aim: This randomised controlled experimental study was conducted to determine the effect of Helfer Skin Tap Technique and Buzzy® application on the pain level during measles-mumps-rubella-mumps (MMR) vaccine injection in 4-year-old children.Method: The study was a randomised controlled experimental study. The sample of the study consisted of 96 children (buzzy: 32, helfer skin tap: 32, control: 32) who underwent MMR vaccination at Bakırköy Family Health Centre No. 9 between May 2023 and October 2023. Data Collection Form, Wong-Baker pain scale, Fear scale and Buzzy® device were used as data collection tools. Buzzy® and Helfer skin tap technique were applied to the children in the intervention group before and after the vaccine injection, while routine vaccine injection was applied to the children in the control group. Children's pain and fear responses were evaluated by the nurse and parents before and after vaccine injection, and physiological parameters were evaluated by the nurse before and after vaccine injection. conditions: Child, Only studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: PARTICIPANT count: 96 type: ACTUAL name: Helfer Skin Tap name: Buzzy measure: Child Information Form measure: Wong-Baker Scale (Pain Facial Expression Scale) measure: Child Fear Scale sex: ALL minimumAge: 4 Years maximumAge: 4 Years stdAges: CHILD facility: Tarsus University city: Mersin zip: 33400 country: Turkey lat: 36.79526 lon: 34.61792 hasResults: False

 nctId: NCT06312215 id: 1763831 briefTitle: Effect Of Open And Closed System Peripheral Catheters Used In Pediatric Services overallStatus: COMPLETED date: 2023-05-26 date: 2023-10-02 date: 2023-10-02 date: 2024-03-15 date: 2024-03-15 name: Tarsus University class: OTHER briefSummary: The study was conducted as a randomized controlled experimental research to examine the effects of open and closed system peripheral catheters on the success of insertion, duration of stay, and development of complications in children aged 1-18 years in pediatric services. The population of the study consisted of children admitted to the Pediatric Services of the Istanbul Faculty of Medicine, and the sample included a total of N=80 children who met the sample criteria and underwent catheter insertion between May 2023 and October 2023. The sample was divided into two groups: closed system peripheral venous catheter group (n=40) and open system peripheral venous catheter group (n=40). The data of the study were collected using a Data Collection Form, Peripheral Venous Catheter Monitoring Form, Visual Infusion Phlebitis Detection Scale, and Pediatric Peripheral Intravenous Infiltration Scale conditions: Child, Only conditions: Catheter Infection conditions: Catheter Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ACTUAL name: Closed-system catheter measure: Patient Identification Form measure: Daily Monitoring Form measure: Visual Infusion Phlebitis Assessment Scale, Staging Key - Peripheral IV'sVIPAS measure: Pediatric peripheral intravenous infiltration assessment tool sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Tarsus University city: Mersin zip: 33400 country: Turkey lat: 36.79526 lon: 34.61792 hasResults: False

 nctId: NCT06312202 id: DROWN_HARBOUR briefTitle: Drowning Incidents in Danish Harbours acronym: DROWN_HARBOR overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-15 date: 2024-03-25 name: Prehospital Center, Region Zealand class: OTHER briefSummary: A recent study reported significantly increased mortality from drowning-related out-of-hospital cardiac arrest in Danish harbours compared to other public places (e.g., public pools, coastlines, and lakes). Accurate and reliable data are necessary before establishing specific educational, preventative, rescue, or treatment strategies to reduce the number of drowning incidents in Danish harbours and improve survival. Therefore, it is essential to characterise drowning incidents in Danish harbours and analyse risk factors associated with fatal drowning. conditions: Drowning conditions: Drown conditions: Drowning; Anoxia conditions: Drowning, Near conditions: Drowning; Asphyxia conditions: Drowning and Nonfatal Submersion conditions: Drowning or Immersion of Unknown Intent conditions: Drowning and Submersion, Undetermined Intent conditions: Drowning and Submersion While in Natural Water conditions: Drowning and Submersion Due to Sailboat Sinking conditions: Drowning and Submersion Due to Fall Off Ship studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: Drowning measure: Yearly incidence of drowning incidents measure: Fatal to non-fatal drowning ratio measure: Assess risk factors associated with 30-day mortality sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Prehospital Center city: Næstved state: Region Zealand zip: 4700 country: Denmark lat: 55.22992 lon: 11.76092 hasResults: False

 nctId: NCT06312189 id: NBI-98854-HD3022 briefTitle: Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea Associated With Huntington Disease in Canada overallStatus: ENROLLING_BY_INVITATION date: 2024-03 date: 2026-03 date: 2026-03 date: 2024-03-15 date: 2024-03-15 name: Neurocrine Biosciences class: INDUSTRY briefSummary: This study will evaluate long-term safety and tolerability of valbenazine in participants with chorea associated with Huntington Disease (HD) who participated in Study NBI-98854-HD3006 (NCT04400331) in Canada. conditions: Chorea, Huntington studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 7 type: ESTIMATED name: Valbenazine measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Neurocrine Clinical Site city: Vancouver state: British Columbia zip: V6T 2B5 country: Canada lat: 49.24966 lon: -123.11934 facility: Neurocrine Clinical Site city: Ottawa state: Ontario zip: K1Y 4E9 country: Canada lat: 45.41117 lon: -75.69812 facility: Neurocrine Clinical Site city: Toronto state: Ontario zip: MK2 1E1 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06312176 id: 2870-010 id: MK-2870-010 type: OTHER domain: Merck id: 2023-504918-29 type: REGISTRY domain: EU CT id: U1111-1289-8119 type: OTHER domain: UTN briefTitle: A Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010) overallStatus: RECRUITING date: 2024-04-13 date: 2027-07-11 date: 2031-04-12 date: 2024-03-15 date: 2024-04-05 name: Merck Sharp & Dohme LLC class: INDUSTRY briefSummary: The purpose of this study is to compare MK-2870 as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer.

The primary hypotheses are that MK-2870 as a single agent and MK-2870 plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants. conditions: Breast Neoplasms studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1200 type: ESTIMATED name: MK-2870 name: Pembrolizumab name: Paclitaxel name: Nab-paclitaxel name: Capecitabine name: Liposomal doxorubicin measure: Progression-Free Survival (PFS) (MK-2870 versus treatment of physician's choice [TPC]; MK-2870 + pembrolizumab versus TPC) measure: Overall Survival (OS) measure: Progression-Free Survival (PFS) (MK-2870 + pembrolizumab versus MK-2870) measure: Objective Response Rate (ORR) measure: Duration of Response (DOR) measure: Change from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) measure: Change from baseline in physical functioning score, on the EORTC QLQ-C30 measure: Change from baseline in emotional functioning score, on the EORTC QLQ-C30 measure: Change from baseline in fatigue score, on the EORTC QLQ-C30 measure: Change from baseline in diarrhea score, on the EORTC QLQ-C30 measure: Time to first Deterioration (TTD) in global health status/quality of life scores, on the EORTC QLQ-C30 measure: TTD in physical functioning score, on the EORTC QLQ-C30 measure: TTD in emotional functioning score, on the EORTC QLQ-C30 measure: TTD in fatigue score, on the EORTC QLQ-C30 measure: TTD in diarrhea score, on the EORTC QLQ-C30 measure: Number of participants who experience one or more adverse events (AEs) measure: Number of participants who discontinue study treatment due to an AE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rambam Health Care Campus-Oncology Division ( Site 1452) status: RECRUITING city: Haifa zip: 3109601 country: Israel name: Study Coordinator role: CONTACT phone: 972-4-777-6700 lat: 32.81841 lon: 34.9885 hasResults: False

 nctId: NCT06312163 id: EHRD1001 briefTitle: Validation of Innovative Scheimpflug Topography Derived RGP Contact Lens Designs In Optometry Network acronym: VISION overallStatus: COMPLETED date: 2022-06-06 date: 2023-12-15 date: 2023-12-15 date: 2024-03-15 date: 2024-03-15 name: Moorfields Eye Hospital NHS Foundation Trust class: OTHER briefSummary: The goal of this Prospective, single-site, cohort study is to validate rigid gas permeable corneal contact lens (RGP) designs for keratoconus derived from combining the data from corneal topography scans and contact lenses ordered in patients with keratoconus (KC) attending a UK tertiary NHS Hospital contact lens clinic. The main questions it aims to answer are:

* Does a Scheimpflug topography derived RGP contact lens design for keratoconus have the equivalent overall contact lens fit as the patients' own lens?
* Is the number of trial lenses required to fit a patient is reduced compared to standard practice?
* Is the time taken to fit a contact lens is reduced compared to standard practice?
* Is there user acceptance of the new lens?
* Are the Axial ege lift (AEL) changes clinically significant?

There will be 3 work packages

WP1: For each participant data collection will take place over two visits.

• Visit 1: Pentacam topography scans and optimal 'virtual' lens selection will take place. • • Visit 2: Participants are fitted with 4 contact lenses (i) the optimal lens design as specified by the virtual fitting module, (ii) a contact lens with a clinically significant step flatter AEL (iii) a contact lens steeper in axial edge lift (AEL) (iv) the participant's own contact lens.

Each CL fit will be assessed with slit lamp photography according to the standardised method proposed by Wolffsohn et al. (2013), Anterior segment OCT MS39) (CSO Hansom Instruments, UK) and best-corrected visual acuity with each lens design using high-contrast logMAR .

WP2. Participants will attend one appointment where a traditional lens fit, and a lens fitted using the topography guided 'virtual' module will be undertaken (with the fitting method selected for each eye randomised). For each fitting method the total fitting time will be measured and the total number of trial contact lenses used. Patients will be invited to complete a questionnaire that probes their satisfaction of this process.

WP3. Clinicians not involved in the study will be invited to examine a demo version of the virtual fitting module and complete the validated system usability scale tool. conditions: Keratoconus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ACTUAL name: The contact lens to be investigated in this study (Scheimpflug topography derived corneal RGP contact lens design). A CE (UKCA) marked class 2 medical devices. measure: Rigid gas permeable contact lens fit measure: The changes in contact lens fit from increased and decreased Axial Edge lift measure: Best corrected Visual Acuity measure: Clinician Usability Assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Moorfields Eye Hospital NHS Foundation Trust city: London zip: EC1V 2PD country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06312150 id: BETA 3 2019 briefTitle: Role of Tumoral Biomarker B3 Adrenergic Receptor in Paediatric Solid Tumours overallStatus: RECRUITING date: 2019-12-17 date: 2025-09 date: 2025-12 date: 2024-03-15 date: 2024-03-18 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Childhood cancers are the third leading cause of death among children between the ages of 1 and 4, and the second leading cause of death among children aged 5-14 years. Biologically, it has been demonstrated that tumour aggressiveness and invasive capacity are caused by genetic modifications and cellular microenvironmental factors in a sequential and multifactorial process. The search for genetic alterations, proteins, or entire intracellular signalling pathways involved in the process of carcinogenesis and metastatisation is always evolving in order to identify new prognostic factors or potential therapeutic targets. In recent years, β-adrenergic receptors (β-ARs) have been associated with tumour progression.

This is a multicentre biological samples study which main aim is to evaluate the β3 receptor expression in the peripheral blood of patients with solid tumours compared to a healthy control group. The biological samples collected during the study are: peripheral blood sample, bone marrow aspirate and fresh or fresh paraffin biopsy tumour. conditions: Tumor studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 60 type: ESTIMATED name: Analysis of peripheral blood (control group) name: Analysis of biological sample (Substudy-solid neoplasms) name: Analysis of biological sample (substudy-leukaemia patients) measure: Evaluation of β3 receptor expression in the peripheral blood, bone marrow and bioptic samples of patients with solid tumours compared to a healthy control group measure: Assessment of oxidative stress in peripheral blood samples from enrolled patients measure: Evaluation of the role of the β3 receptor in apoptosis resistance (substudy) sex: ALL minimumAge: 1 Day maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale San Donato di Arezzo status: NOT_YET_RECRUITING city: Arezzo country: Italy name: Carlo Milandri role: CONTACT email: carlo.milandri@uslsudest.toscana.it lat: 43.46276 lon: 11.88068 facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence country: Italy name: Annalisa Tondo role: CONTACT phone: 0555662489 email: annalisa.tondo@meyer.it lat: 43.77925 lon: 11.24626 facility: Azienda Ospedaliera Pisana status: ACTIVE_NOT_RECRUITING city: Pisa country: Italy lat: 43.70853 lon: 10.4036 hasResults: False

 nctId: NCT06312137 id: 2870-019 id: 2023-508012-35 type: REGISTRY domain: EU CT id: MK-2870-019 type: OTHER domain: Merck Id briefTitle: A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019) overallStatus: RECRUITING date: 2024-04-03 date: 2034-02-21 date: 2034-10-23 date: 2024-03-15 date: 2024-04-25 name: Merck Sharp & Dohme LLC class: INDUSTRY briefSummary: This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR). conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a multi site study primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 780 type: ESTIMATED name: Sacituzumab tirumotecan name: Pembrolizumab name: Cisplatin name: Pemetrexed name: Gemcitabine name: Carboplatin name: Paclitaxel measure: Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR) measure: Overall Survival (OS) measure: Distant metastasis-free survival (DMFS) as assessed by investigator measure: Disease-Free Survival (DFS) as assessed by investigator measure: Lung Cancer Specific Survival (LCSS) measure: Number of Participants Who Experience at least One Adverse Event (AE) measure: Number of Participants Who Discontinue Study Intervention Due to AEs measure: Change from Baseline in Global Health Status/Quality of Life (QoL) score (Quality of Life Questionnaire (QLQ)-C30 Items 29 and 30) measure: Change from Baseline in Physical Functioning Score (QLQ-C30 Items 1 to 5) measure: Change from Baseline in Role Functioning Score (QLQ-C30 Items 6 and 7) measure: Change from Baseline in Dyspnea scores (QLQ-C30 Item 8) measure: Change from Baseline in Coughing scores (QLQ-LC24 Items 31 and 52) measure: Change from Baseline in Chest pain scores (QLQ-LC24 Item 40) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mid Florida Hematology and Oncology Center ( Site 0018) status: RECRUITING city: Orange City state: Florida zip: 32763 country: United States name: Study Coordinator role: CONTACT phone: 407-353-1915 lat: 28.94888 lon: -81.29867 facility: Rambam Health Care Campus-Oncology Division ( Site 2203) status: RECRUITING city: Haifa zip: 3109601 country: Israel name: Study Coordinator role: CONTACT phone: 04-777-6700 lat: 32.81841 lon: 34.9885 facility: Shaare Zedek Medical Center ( Site 2206) status: RECRUITING city: Jerusalem zip: 9103102 country: Israel name: Study Coordinator role: CONTACT phone: +972587040620 lat: 31.76904 lon: 35.21633 facility: Rabin Medical Center ( Site 2204) status: RECRUITING city: Petah Tikva zip: 4941 492 country: Israel name: Study Coordinator role: CONTACT phone: + 9729378101 lat: 32.08707 lon: 34.88747 facility: National Cheng Kung University Hospital-Clinical Trial Center ( Site 1102) status: RECRUITING city: Tainan zip: 704 country: Taiwan name: Study Coordinator role: CONTACT phone: 886-912777918 lat: 22.99083 lon: 120.21333 hasResults: False

 nctId: NCT06312124 id: 24-006 briefTitle: A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer overallStatus: RECRUITING date: 2024-03-08 date: 2028-03-08 date: 2028-03-08 date: 2024-03-15 date: 2024-03-15 name: Memorial Sloan Kettering Cancer Center class: OTHER briefSummary: The purpose of this study is to find out how many participants are interested in a surgical preventive procedure after watching an educational video. Before and after watching the video, participants will complete questionnaires in the clinic. conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: NONE count: 400 type: ESTIMATED name: Educational Module name: Salpingectomy measure: Rate of Opportunistic Salpingectomy/OS after completion of educational module sex: FEMALE minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins University (Data Collection Only) status: NOT_YET_RECRUITING city: Baltimore state: Maryland zip: 21287 country: United States name: Rebecca Stone, MD role: CONTACT phone: 410-955-8240 lat: 39.29038 lon: -76.61219 facility: Dana Farber Cancer Institute (Data Collection Only) status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Michelle Davis, MD role: CONTACT phone: 617-732-8840 lat: 42.35843 lon: -71.05977 facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) status: RECRUITING city: Basking Ridge state: New Jersey zip: 07920 country: United States name: Kara Long Roche, MD role: CONTACT phone: 646-608-3787 lat: 40.70621 lon: -74.54932 facility: Memorial Sloan Kettering Monmouth (Limited protocol activities) status: RECRUITING city: Middletown state: New Jersey zip: 07748 country: United States name: Kara Long Roche, MD role: CONTACT phone: 646-608-3787 lat: 40.39652 lon: -74.09211 facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities) status: RECRUITING city: Montvale state: New Jersey zip: 07645 country: United States name: Kara Long Roche, MD role: CONTACT phone: 646-608-3787 lat: 41.04676 lon: -74.02292 facility: Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) status: RECRUITING city: Commack state: New York zip: 11725 country: United States name: Kara Long Roche, MD role: CONTACT phone: 646-608-3787 lat: 40.84288 lon: -73.29289 facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities) status: RECRUITING city: Harrison state: New York zip: 10604 country: United States name: Kara Long Roche, MD role: CONTACT phone: 646-608-3787 lat: 40.96899 lon: -73.71263 facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities) status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Kara Long Roche, MD role: CONTACT phone: 646-608-3787 lat: 40.71427 lon: -74.00597 facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities) status: RECRUITING city: Uniondale state: New York zip: 11553 country: United States name: Kara Long Roche, MD role: CONTACT phone: 646-608-3787 lat: 40.70038 lon: -73.59291 facility: MD Anderson Cancer Center (Data Collection Only) status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Karen Lu, MD role: CONTACT phone: 713-745-8902 lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06312111 id: 62/2021 briefTitle: Physical Activity and Various Aspects of Quality of Life in Patients With Pulmonary Arterial Hypertension (Ph-PAH) acronym: PhA-PAH overallStatus: COMPLETED date: 2021-04-22 date: 2021-07-15 date: 2022-07-17 date: 2024-03-15 date: 2024-03-15 name: Centre of Postgraduate Medical Education class: OTHER briefSummary: Evaluate whether education, a simple doctor's recommendation to increase physical activity in inactive patients, and self-monitoring of physical activity using a pedometer were effective and beneficial for patients with pulmonary arterial hypertension (PAH) conditions: Pulmonary Arterial Hypertension conditions: Physical Inactivity studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 48 type: ACTUAL name: recommendation to increase physical activity measure: Number of steps per day measure: Change in 6-minute walk distance measure: Change in quality of life (SF-36) measure: Change in the hospital anxiety and depression scale (HADS) measure: Change in the acceptance of illness (AIS) measure: Change in N-Terminal Pro-B-Type Natriuretic Peptide level (NT-proBNP) measure: Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWD measure: Compliance with counting steps sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, European Health Centre, Otwock, Centre of Postgraduate Medical Education city: Otwock state: Borowa 14/18 zip: 05-400 country: Poland lat: 52.10577 lon: 21.26129 hasResults: False

 nctId: NCT06312098 id: KC21RISI0576 briefTitle: Perioperative Factors and Living Donor Liver Transplantation overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-07-01 date: 2024-03-15 date: 2024-03-18 name: Min Suk Chae class: OTHER briefSummary: Liver transplant surgery is one of the treatments provided to patients suffering from end-stage liver disease, and has a successful treatment prognosis. However, it is clear that patient management before, during, and after surgery is a difficult task for medical staff due to the complex clinical and pathological problems of end-stage liver disease. Moreover, the complex surgical technique of the liver transplant surgery itself and the severe hemodynamic fluctuations and multi-organ dysfunction that patients experience during the surgery have been shown to have a tremendous impact on the patient's prognosis after surgery.

A study on which clinical, laboratory, and hemodynamic factors experienced by patients during the perioperative period, including before, during, and after surgery, affect the survival rate of patients and transplanted organs. will definitely be helpful in the treatment of patients suffering from end-stage liver disease. conditions: Liver Transplant Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 533 type: ESTIMATED name: remote ischemic preconditioning (RIPC) measure: Incidence of postreperfusion syndrome sex: ALL minimumAge: 19 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06312085 id: EF_5301_V1.0_CIP briefTitle: A Study to Assess the Clinical Success of Root Canal Treatment Using Novel Obturation Material. overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2026-12 date: 2024-03-15 date: 2024-03-15 name: Lumendo AG class: INDUSTRY name: Avania briefSummary: The goal of this study is prospective, single-arm, non-randomized controlled trial to test the effectiveness, safety and performance of a novel dental obturation material. The main question sit answers is

1. To test the effectiveness of the Endofill device for root canal obturation up to 12-month follow-up period.
2. To test the performance of the Endofill device evaluated with periapical radiographs immediately on completion of procedure.

The participants requiring root canal treatment will be treated with obturated using Endofill material and post-treatment follow-up vistis will be conducted for 1 year. This is a single-arm study with no comparison groups. conditions: Endodontic Treatment studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 63 type: ESTIMATED name: Endofill measure: Effectiveness of root canal treatment using Endofill measure: Safety of root canal treatment using endofill sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medipol University city: Istanbul country: Turkey name: Tan Firat Eyuboglu role: CONTACT phone: +905304636059 email: tfeyuboglu@yahoo.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06312072 id: 23-019 briefTitle: Understanding Risk Factors for Progressive Chronic Kidney Disease in Malawi overallStatus: RECRUITING date: 2024-02-14 date: 2025-12 date: 2025-12 date: 2024-03-15 date: 2024-03-15 name: Liverpool School of Tropical Medicine class: OTHER name: Wellcome Trust name: Malawi Epidemiology and Intervention Research Unit name: London School of Hygiene and Tropical Medicine name: University of Glasgow name: Malawi-Liverpool-Wellcome Trust Clinical Research Programme briefSummary: Worldwide, the number of people living with long-term health conditions, including chronic kidney disease (CKD), is increasing. CKD is usually asymptomatic in early stages but can progress to advanced disease, including kidney failure, causing significant morbidity and mortality.

In low-income countries of sub-Saharan Africa, including Malawi, treatments for kidney failure are not yet widely available and are prohibitively expensive . It is therefore vital to:

(a) Prevent development of CKD in the first place (b) Detect CKD earlier so that more cost-effective treatments can be given to slow progression.

There is little evidence on factors that drive CKD progression in Malawi, or on interventions that may be cost-effective for improving detection and slowing disease progression in this setting. This PhD will address these knowledge gaps, through the following aims:

1) Determine the mortality associated with CKD, and the risk factors driving its development and progression in Malawian adults 2) Investigate the impacts of different models for integrating screening and prevention strategies for CKD and its risk factors into health services for other long-term conditions in low- and middle-income countries 3) With patients, carers, healthcare workers and policy makers, evaluate the feasibility and acceptability of different potential models for integrating CKD screening and prevention strategies into health services for high-risk patient groups in Malawi conditions: Chronic Kidney Diseases conditions: Non-Communicable Chronic Diseases conditions: Non-communicable Disease conditions: Kidney Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1100 type: ESTIMATED name: No intervention; observational study measure: Aim 1, objective 3 primary outcome measure measure: Aim 1, objective 2 primary outome measure measure: Aim 1, objective 1 primary outcome measure: measure: Aim 1, objective 3 secondary outcome measure 1: measure: Aim 1, objective 3 secondary outcome measure 2: measure: Aim 1, objective 3 secondary outcome measure 3: measure: Aim 1, objective 3 secondary outcome measure 4: measure: Aim 1, objective 3 secondary outcome measure 5: measure: Aim 1, objective 3 secondary outcome measure 6: measure: Aim 1, objective 2 secondary outcome measure: measure: Aim 1, objective 1 secondary outcome measure: sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Malawi Epidemiology and Intervention Research Unit status: RECRUITING city: Chilumba state: Karonga zip: P.O. Box 46 country: Malawi name: Laurence Tembo role: CONTACT phone: +265 888 348 705 email: charlotte.snead@lstmed.ac.uk name: Mia Crampin, MB ChB msC role: CONTACT email: mia.crampin@lshtm.ac.uk name: Charlotte Snead, BA BMBCh role: PRINCIPAL_INVESTIGATOR name: Henry Mwandumba role: SUB_INVESTIGATOR name: Alison Price, BVSc DPhil role: SUB_INVESTIGATOR name: Felix Limbani, PhD MPH BSc role: SUB_INVESTIGATOR name: Dominic Taylor, MD MBChB role: SUB_INVESTIGATOR name: Chimota Phiri role: SUB_INVESTIGATOR name: Charles Munthali role: SUB_INVESTIGATOR name: Mia Crampin, MBChB MSc role: SUB_INVESTIGATOR lat: -11.1 lon: 33.68333 hasResults: False

 nctId: NCT06312059 id: KNC-GMS-002 briefTitle: Goat or Cow Milk Based Infant Formula GMS overallStatus: RECRUITING date: 2023-12-14 date: 2024-08-15 date: 2024-08-15 date: 2024-03-15 date: 2024-03-15 name: Kendal Nutricare Ltd class: INDUSTRY name: ObvioHealth briefSummary: This study is a non-inferiority, decentralized, randomized, double-blind, controlled clinical trial evaluating the growth, tolerance, and safety of a goat's-milk test infant formula (Test Formula 1; TF1) and a cow's-milk test infant formula (Test Formula 2; TF2), each compared to a cow's-milk infant formula commercially available in the United States (Control Formula; CF). conditions: Growth studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: QUADRUPLE maskingDescription: RP Over stickered TP in blank packaging. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 264 type: ESTIMATED name: "Similac® Advance Infant Formula Powder name: "Kendamil Cow milk test product name: "Kendamil goat milk test product measure: Growth as compared against WHO growth charts measure: Safety measure: Tolerability- Monitoring of stool consistency measure: Tolerability - fussiness measure: Mean Daily Recumbent Length Gain measure: Mean Daily Head Circumference Gain sex: ALL maximumAge: 14 Days stdAges: CHILD facility: ObvioHealth USA, Inc. status: RECRUITING city: New York state: New York zip: 10001 country: United States name: Parth Shah role: CONTACT phone: 513-571-5377 email: parth.shah@obviohealth.com lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06312046 id: 2018 374-31 briefTitle: Motor-cognitive Performance in People With Multiple Sclerosis acronym: HiBalance-MS overallStatus: RECRUITING date: 2024-02-26 date: 2025-12-31 date: 2027-08-31 date: 2024-03-15 date: 2024-03-15 name: Karolinska Institutet class: OTHER name: Karolinska University Hospital briefSummary: Having a neurological disease such as multiple sclerosis (MS) leads to difficulties in balance and gait with or without concurrent performance of cognitive tasks, hindering activity performance and influencing the possibilities for an independent lifestyle.

The investigators have adapted a previously developed balance training program to a highly challenging program specifically directed to MS (HiBalance-MS). This program was recently tested and found feasible in a pilot study. The investigators will now perform a randomized controlled trial in people with MS, in order to determine the effects of the program. The hypothesis is that progressively challenging balance exercise programs that are specific to the balance control domains affected by MS will be effective to improve balance control, walking, motor-cognitive performance, activity performance and health related quality of life. conditions: Multiple Sclerosis conditions: Postural Balance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigator and Outcome assessor will not participate in the provided training program. Care provider will not perform the analyses. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: HiBalance-MS measure: Mini Balance Evaluation Systems test. measure: 10-Meter Walk Test, maximum speed. measure: 10-Meter Walk Test, self-selected speed. measure: 2-Minute Walk Test, self-selected speed. measure: Gait speed during simultaneous dual task performance. measure: Stride length during dual task gait performance. measure: Step time during dual task gait performance. measure: Response errors in dual task cognitive performance measure: Reaction time in dual task cognitive performance measure: Six-Spot Step Test. measure: Completion time in the Trail Making Test. measure: Number of errors in the Trail Making Test. measure: Immediate and delayed recall in the Ray Auditory Verbal Learning Test. measure: Cognitive processing speed in the Symbol Digit Modalities Test. measure: Cognitive function - composite measure of three cognitive tests. measure: Physical activity level. measure: Physical activity level, self-reported. measure: Physical exercise habits, self-reported. measure: The generic Walk-12 questionnaire. measure: Falls Efficacy Scale - International. measure: Assesment of anxiety with the Hospital Anxiety and Depression Scale. measure: Assesment of depression with the Hospital Anxiety and Depression Scale. measure: Modified Fatigue Impact Scale. measure: Occupational Gap Questionnaire. measure: Acceptance of Chronic Health Condition scale. measure: Multiple Sclerosis Impact Scale - physical impact. measure: Multiple Sclerosis Impact Scale - psychological impact. measure: Euroqol-5 Dimensions-5 Level (EuroQoL-5D-5L). measure: Euroqol Visual Analogue Scale (EQ VAS). measure: World Health Organization Disability Assessment Schedule, version 2.0. (WHODAS 2.0) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karolinska Institutet status: RECRUITING city: Stockholm zip: 17177 country: Sweden name: Sverker Johansson, Ph.D role: CONTACT phone: +46702861260 email: sverker.johansson@ki.se name: Andreas Wallin, Ph.D role: CONTACT phone: +46735137604 email: andreas.wallin@ki.se lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06312033 id: MRTG_P01 briefTitle: Estradiol's Effect on Brain Volume and Connectivity overallStatus: COMPLETED date: 2018-08-01 date: 2019-07-31 date: 2021-12-31 date: 2024-03-15 date: 2024-03-15 name: International Research Training Group 2804 class: OTHER name: University Hospital Tübingen name: German Research Foundation name: Werner Reichardt Centrum für Integrative Neurowissenschaften (CIN) briefSummary: Ovarian hormones are not only modulators of cognitive function, emotion regulation and mental health, but also seem to affect brain plasticity and functional connectivity, During the menstrual cycle, women experience cyclic fluctuation of the ovarian hormone estradiol, which is closely associated with neuroplasticity/changes in brain structure in regions with high estradiol receptor density, such as the amygdala, hippocampus/parahippocampus, anterior cingulate cortex (ACC), striatum, and prefrontal cortex (PFC). Further functional connectivity between these areas seems to be associated with hormonal changes dependent on the menstrual cycle phase. But next to estradiol, also other hormones like progesterone fluctuate across the menstrual cycle. In the past, effects of ovarian hormone levels were often investigated in combination. However, one way to disentangle the impact of estradiol from that of other hormones on neuroplasticity, emotion regulation and mood states, can be the experimental increase of estradiol via estradiol administration. In this double-blinded within-subject study, women were administered either estradiol valerate or placebo during the early follicular phase (thus when ovarian hormone concentrations are low) before undergoing neuroimaging.

Parts of the study are already described in Rehbein et al., 2021 and 2022. conditions: Emotion Regulation conditions: Estradiol studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The intervention assessed the effect of estradiol administration on stress reactivity using a double blind randomized within -between placebo-controled design with repeated measures. primaryPurpose: OTHER masking: TRIPLE maskingDescription: Neither participant or investigator knew the timepoint of drug or placebo administration. Pills were prepared by independent members of the university hospital. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 32 type: ACTUAL name: Estradiol Valerate name: Placebo measure: Impact of E2 concentration on brain structure measure: Impact of E2 concentration and state emotion regulation on brain structure measure: Impact of E2 concentration and emotion regulation traits on brain structure measure: Impact of E2 concentration on resting state functional connectivity measure: Impact of E2 concentration and state emotion regulation on connectivity measure: Impact of E2 concentration and emotion regulation traits on functional connectivity measure: Impact of E2 concentration and associated structural brain changes on connectivity measure: Impact of E2 concentration and self-esteem on brain structure measure: Impact of E2 concentration and self-esteem on functional connectivity measure: Impact of E2 concentration and subjective mood on brain structure measure: Impact of E2 concentration and state anxiety on brain structure measure: Impact of E2 concentration and subjective mood on functional connectivity measure: Impact of E2 concentration and state anxiety on functional connectivity measure: Impact of E2 administration on E2 concentrations measure: Impact of E2 administration on E2-progesterone ratio measure: Impact of E2 administration on testosterone and progesterone concentration sex: FEMALE minimumAge: 19 Years maximumAge: 35 Years stdAges: ADULT facility: University of Tuebingen; Department of Psychiatry & Psychotherapy city: Tuebingen state: BW zip: 72076 country: Germany lat: 48.52266 lon: 9.05222 hasResults: False

 nctId: NCT06312020 id: HZNP-HZN-1116-201 briefTitle: A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-09-03 date: 2026-11-26 date: 2024-03-15 date: 2024-03-15 name: Horizon Therapeutics Ireland DAC class: INDUSTRY briefSummary: The purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren's syndrome (SS). conditions: Sjogren's Syndrome studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 262 type: ESTIMATED name: HZN-1116 name: Placebo measure: Change from baseline in European Alliance of Associations for Rheumatology (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) (Population #1) measure: Change from baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) (Population #2) measure: Change from baseline in ESSDAI (Population #1) measure: Proportion of Participants achieving ESSDAI [5] response (Population #1) measure: Change from baseline in ESSPRI pain domain score (Population #1) measure: Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) pain domain score (Population #1) measure: Change from baseline in ESSPRI fatigue domain score (Population #1) measure: Change from baseline in DASPRI fatigue domain score (Population #1) measure: Change from baseline in ESSPRI dryness domain score (Population #1) measure: Change from baseline in DASSPRI dryness domain score (Population #1) measure: Change from baseline in tender joint count (TJC) (Population #1) measure: Change from baseline in swollen joint count (SJC) (Population #1) measure: Change from baseline in 36-item Short Form Survey (SF-36) physical component score (PCS) (Population #1) measure: Change from baseline in 36-item Short Form Survey (SF-36) mental component score (MCS) (Population #1) measure: Change from baseline in patient-reported outcomes measurement information system (PROMIS)-Fatigue SF-10a (Population #1) measure: Change from baseline in DASPRI (Population #2) measure: Proportion of Participants achieving ESSPRI [1.5] response (Population #2) measure: Change from baseline in ESSPRI pain domain (Population #2) measure: Change from baseline in ESSPRI fatigue domain (Population #2) measure: Change from baseline in ESSPRI dryness domain (Population #2) measure: Change from baseline in SF-36 PCS Score (Population #2) measure: Change from baseline in 36-item Short Form Survey (SF-36) mental component score MCS (Population #2) measure: Change from baseline in PROMIS-Fatigue SF-10a (Population #2) measure: Serum concentration of HZN-1116 starting at Week 1 through study completion (Population #1 and #2) measure: Proportion of Participants who develop anti drug antibodies (ADA) over time (Population #1 and #2) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06312007 id: UH23030202 briefTitle: Semi-seated Holding Position to Reduce Stress Responses in in the Neonatal Intensive Care Unit overallStatus: COMPLETED date: 2023-07-01 date: 2023-11-01 date: 2023-12-01 date: 2024-03-15 date: 2024-03-15 name: Hasanuddin University class: OTHER briefSummary: This study to compare half semi seated position and side lying position with cortisol level on the neonate's stress respon conditions: Semi Seated Position conditions: Side Lying Position studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention semi seated position Control side lying position primaryPurpose: OTHER masking: NONE count: 45 type: ACTUAL name: Semi seated position name: side lying position measure: Kortisol level measure: Oxytocin level sex: ALL minimumAge: 32 Weeks maximumAge: 42 Weeks stdAges: CHILD facility: Hasanuddin University city: Makassar state: South Sulawesi country: Indonesia lat: -5.14861 lon: 119.43194 hasResults: False

 nctId: NCT06311994 id: GumushaneUni briefTitle: Applicability and Efficiency of Virtual Reality Intervention in Knee Surgery Patients overallStatus: RECRUITING date: 2024-02-01 date: 2024-05-01 date: 2025-04-01 date: 2024-03-15 date: 2024-03-15 name: Gümüşhane Universıty class: OTHER briefSummary: The stress experienced by patients in hospital environments can lead to a range of issues, from clinical decision-making to discharge. Although stress levels can contribute to new problems, individual characteristics also play a significant role in clinical recovery. Knee surgery is a commonly performed procedure in our country that provides patients with an effective solution to joint-related issues. However, stress experienced by patients who undergo surgery can have negative consequences, from managing problems during their hospital stay to their overall quality of life. The search for effective stress management methods is ongoing and has gained momentum with the development of new technological products. Virtual reality (VR) applications are a novel approach in the literature for managing various issues. Research is being conducted in different areas of our country using this approach. The aim of this project is to evaluate the feasibility, acceptability, and effectiveness of different environment perceptions using virtual reality glasses on postoperative mobilization and well-being in individuals undergoing knee surgery for the first time. The project sample is a randomized controlled trial consisting of 30 patients who will undergo orthopedic surgery for the first time at the Gümüşhane State Hospital orthopedic clinic and meet the acceptance criteria. In the intervention group, patients will view relaxing virtual environment images with VR glasses after surgery. Following the relaxation session, participants will be presented with content to exercise in the virtual environment. Patients will be instructed to perform breathing exercises set in forest and underwater scenes to aid relaxation. The effectiveness of the intervention will be assessed using the Tampa Kinesiophobia Scale and Patient Mobility Scale. A satisfaction scale with a linear format will be used to evaluate the acceptability of the intervention. In addition, a data collection form, developed by the researcher, will be used to gather information on participant characteristics. The obtained data will be analyzed using t-tests, analysis of variance, correlation, and regression tests. Currently, there is a growing number of studies that explore the relationship between technology and health. This project aims to investigate the impact of virtual reality glasses on symptom management. If the results are positive, this method could be used as a solution for various situations where individuals experience symptoms. The goal is to develop a usable product for postoperative mobilization based on the research findings. conditions: Virtual Reality conditions: Symptom Management conditions: Surgery conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Virtual reality measure: Pain measure measure: Stress measure: Mobilization measure: Mobility sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gumushane University status: RECRUITING city: Gumushane zip: 28010 country: Turkey name: Aydanur Aydin role: CONTACT phone: 0905321730688 email: aydanuraydin_88@hotmail.com lat: 40.46001 lon: 39.47176 hasResults: False

 nctId: NCT06311981 id: SPHIC-TR-THLC2023-08 briefTitle: Carbon Ion Radiotherapy for Locally Advanced Lung Cancer in Elderly Patients overallStatus: RECRUITING date: 2024-04-01 date: 2025-06-17 date: 2026-06-17 date: 2024-03-15 date: 2024-03-15 name: Jian Chen class: OTHER briefSummary: To observe the effect and toxicity of carbon ion radiotherapy on local advanced non-small cell lung cancer over 75 years old patients. Systemic therapy could be targeted therapy, chemotherapy or immunotherapy. conditions: Non-small Cell Lung Cancer conditions: Older People conditions: Carbon Ion Radiotherapy conditions: Radiotherapy Side Effect studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 29 type: ESTIMATED name: carbon ion radiotherapy name: targeted therapy name: single regimen chemotherapy in sequence with radiotherapy measure: Disease progression-free survival rate measure: Incidence of Treatment-induced Adverse Events measure: Local control rate measure: Cause-specific survival rate measure: Overall survival rate sex: ALL minimumAge: 75 Years stdAges: OLDER_ADULT facility: Shanghai Proton and Heavy Ion Center status: RECRUITING city: Shanghai state: Shanghai zip: 201513 country: China name: Jing Li role: CONTACT phone: 86-21-38296678 email: jing.li@sphic.org.cn name: Kun Liu role: CONTACT phone: 86-21-38296678 email: kun.liu@sphic.org.cn name: Jian Chen, MD role: PRINCIPAL_INVESTIGATOR name: Jingfang Mao, PHD role: PRINCIPAL_INVESTIGATOR name: Kai-liang Wu, PHD role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06311968 id: SPHIC-TR-THLC2023-07 briefTitle: The Clinical Study of Post-operative Proton Radiotherapy for Thymus Tumor overallStatus: RECRUITING date: 2024-04-01 date: 2027-02-28 date: 2027-02-28 date: 2024-03-15 date: 2024-03-15 name: Jian Chen class: OTHER briefSummary: To observe the efficacy and toxicities of post-operative (R0/R1) proton radiotherapy for locally advanced primary thymus epithelial malignancies. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was overall survival and cause-specific survival. conditions: Thymus Epithelial Tumor conditions: Proton Radiotherapy conditions: Radiation Toxicity studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 55 type: ESTIMATED name: Proton radiotherapy name: combined platinum based chemotherapy measure: Disease progression-free survival rate measure: Incidence of Treatment-induced Adverse Events measure: Overall survival rate measure: Cause-specific survival rate sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Proton and Heavy Ion Center status: RECRUITING city: Shanghai state: Shanghai zip: 201513 country: China name: Jing Li role: CONTACT phone: 86-21-38296678 email: jing.li@sphic.org.cn name: Kun Liu role: CONTACT phone: 86-21-38296678 email: kun.liu@sphic.org.cn name: Jian Chen, MD role: PRINCIPAL_INVESTIGATOR name: Jingfang Mao, PHD role: PRINCIPAL_INVESTIGATOR name: Kai-liang Wu, PHD role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06311955 id: SPHIC-TR-THLC2023-06 briefTitle: Clinical Study of Postoperative Carbon Ion Radiotherapy for Thymus Tumor With Residual Tumor overallStatus: RECRUITING date: 2024-04-01 date: 2028-02-28 date: 2029-02-28 date: 2024-03-15 date: 2024-03-15 name: Jian Chen class: OTHER briefSummary: To observe the efficacy and toxicities of heavy ion radiation therapy for locally advanced or advanced primary thymic epithelial malignant tumor received R2 resection. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was local relapse-free survival, overall survival and cause-specific survival. conditions: Thymic Epithelial Tumor conditions: Radiotherapy Side Effect conditions: Carbon Ion Radiotheray conditions: Heavy Ion Radiotherapy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Carbon ion radiotherapy name: combined with platinum-based regimen measure: Disease progression-free survival rate measure: Incidence of Treatment-induced Adverse Events measure: Local-progression free survival rate measure: Overall survival rate measure: Cause-specific survival rate sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Proton and Heavy Ion Center status: RECRUITING city: Shanghai state: Shanghai zip: 201513 country: China name: Jing Li role: CONTACT phone: 86-21-38296678 email: jing.li@sphic.org.cn name: Kun Liu role: CONTACT phone: 86-21-38296678 email: kun.liu@sphic.org.cn name: Jian Chen, MD role: PRINCIPAL_INVESTIGATOR name: Jingfang Mao, PHD role: PRINCIPAL_INVESTIGATOR name: Kai-liang Wu, PHD role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06311942 id: Precision AT-02 briefTitle: Triple vs. Dual Adjuvant Therapy Following Liver Resection for HCC. overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-12-31 date: 2028-12-31 date: 2024-03-15 date: 2024-03-15 name: Chen Xiaoping class: OTHER briefSummary: Vessels that encapsulate tumor clusters (VETC) is an invasive metastatic factor in HCC independent of the epithelial mesenchyme transition (EMT), and VETC-positive patients have a higher rate of postoperative recurrence. What can be done to improve the surgical prognosis of this group of patients needs to be continuously explored. conditions: HCC studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: HAIC plus PD-1 inhibitors plus lenvatinib name: PD-1 inhibitors plus lenvatinib measure: DFS measure: OS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06311929 id: Precision AT-01 briefTitle: Precision Adjuvant Therapy After Surgery for Hepatocellular Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-12-31 date: 2028-12-31 date: 2024-03-15 date: 2024-03-15 name: Chen Xiaoping class: OTHER briefSummary: Vessels that encapsulate tumor clusters (VETC) is an invasive metastatic factor in HCC independent of the epithelial mesenchyme transition (EMT), and VETC-positive patients have a higher rate of postoperative recurrence. How to improve the prognosis of this group of patients is an urgent issue to be addressed. conditions: HCC studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: PD-1 monoclonal antibody and lenvatinib name: PD-1 monoclonal antibody measure: Disease-free survival measure: Overall survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06311916 id: Neoadj-Net briefTitle: Efficacy and Safety of Neoadjuvant Therapy in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-12-31 date: 2028-12-31 date: 2024-03-15 date: 2024-03-15 name: Chen Xiaoping class: OTHER briefSummary: Primary liver cancer is one of the most common malignant tumors in the world, and more than 90% of primary liver cancers are pathologically characterized as hepatocellular carcinoma (HCC). The intermediate stage (BCLC-B) HCC is highly heterogeneous, and there is no consensus on the treatment of this stage of the tumor in Western and Eastern countries. New tools are urgently needed to guide the choice of treatment options for patients with this stage of the tumor in order to reduce the risk of postoperative recurrence and the overall survival rate. conditions: HCC studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 312 type: ESTIMATED name: HAIC + Tirelizumab +lenvatinib +liver resection name: liver resection measure: Disease-free survival measure: Safety Assessment sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06311903 id: 36264PR430/11/23 briefTitle: Norepinephrine in Preperiod of Hypotensive Resuscitation in Hemorrhagic Shock overallStatus: RECRUITING date: 2023-12-01 date: 2024-04-01 date: 2024-04-01 date: 2024-03-15 date: 2024-03-15 name: Tanta University class: OTHER briefSummary: The aim of this work was to investigate the effects of low dose of norepinephrine in preperiod of hypotensive resuscitation in hemorrhagic shock. conditions: Norepinephrine conditions: Hemorrhagic Shock conditions: Hypotensive Resuscitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 200 type: ESTIMATED name: Low dose of Norepinephrine (NE) name: High dose of Norepinephrine (NE) measure: 24 hours mortality measure: 28 day mortality measure: Incidence of acute kidney injury measure: Length of hospital stay measure: Length of intensive care unit stay sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tanta University status: RECRUITING city: Tanta state: El-Gharbia zip: 31527 country: Egypt name: Rabab M Mohamed, MD role: CONTACT phone: 00201069122935 email: rabmoh_30@outlook.com name: Atia G Anwar, MD role: PRINCIPAL_INVESTIGATOR name: Ahmed A Eid, MD role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06311890 id: 2023XLA141-2 briefTitle: Study to Evaluate the Efficacy, Safety and Tolerability of Photodynamic Therapy(PDT) With Chlorin-e6 in Treating Moderate to Severe Acne overallStatus: RECRUITING date: 2024-02-01 date: 2026-09-30 date: 2026-09-30 date: 2024-03-15 date: 2024-03-15 name: Xiyuan Hospital of China Academy of Chinese Medical Sciences class: OTHER briefSummary: This study aims to evaluate the clinical efficacy, safety and tolerability of a photodynamic therapy(PDT) based on a new photosensitizer, Chlorin-e6, in the treatment of moderate to severe acne. The hypothesis is that the therapy has good efficacy, safety and tolerability. conditions: Acne conditions: Photodynamic Therapy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 46 type: ESTIMATED name: N-chlorin e6 triglumine name: acne removal surgery measure: Change in Global Acne Grading System (GAGS) Relative to Baseline measure: Change in Inflammatory&non-inflammatory Lesion Counts Relative to Baseline measure: Change in Acne-specific Quality of Life Assessment Instrument（Qol-Acne）Relative to Baseline measure: Change in Numerical Rating Scale(NRS) Relative to Baseline measure: Number of participants with abnormalities of Hematological Parameters and Urine Parameters Relative to Baseline measure: Change in Adverse Reaction Management Form(AR-MF) Relative to Baseline sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Xiyuan Hospital of China Academy of Chinese Medical Sciences Organization status: RECRUITING city: Beijing zip: 100091 country: China name: Huiyan Chi, doctor role: CONTACT phone: 13811626953 email: chihuiyan@163.com name: Yisheng Zhang, doctor role: CONTACT phone: 15652386117 email: llleera@126.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06311877 id: 6795 briefTitle: Effects of Flavor Modification for Management of Radiation Induced Dysgeusia overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-02-14 date: 2025-02-14 date: 2024-03-15 date: 2024-03-15 name: University of South Florida class: OTHER briefSummary: Intervention for dysgeusia in head and neck cancer patients undergoing radiation therapy. This research proposal aims to investigate potential benefits of mBerry in improving quality of life and nutritional outcome in head and neck cancer patients' post-radiation therapy. Our hypothesis is that cancer patients undergoing radiation therapy will benefit from use of miracle berry in treatment of dysgeusia. conditions: Dysgeusia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: mBerry name: No intervention measure: 5-Point Hedonic Rating Scale measure: Chemotherapy-induced Taste Alteration Scale (CITAS) measure: M.D. Anderson Dysphagia Inventory (MDADI) measure: Functional Oral Intake Scale (FOIS) measure: Patients weight measurement sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06311864 id: PROxy240215 briefTitle: Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia With Daridorexant in Canada overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-09-15 date: 2024-09-15 date: 2024-03-15 date: 2024-03-15 name: PeriPharm class: OTHER name: Idorsia Pharmaceuticals Ltd. briefSummary: The purpose of this observational study is to evaluate the impact of daridorexant on quality of life, work productivity and insomnia symptoms in Canadian adults suffering from insomnia. conditions: Insomnia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Daridorexant 50 mg measure: Change from Baseline in Quality of Life measure: Change from Baseline in Work Productivity Loss measure: Change from Baseline in the Severity of Insomnia Symptoms sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PROxy Network, an initiative of PeriPharm inc. city: Montreal state: Quebec zip: H2Y 2H4 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06311851 id: PNCC140201 briefTitle: Transarterial Chemoembolization (TACE) Plus Bevacizumab for Liver Metastases overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-12-01 date: 2024-03-15 date: 2024-04-01 name: Pardis Noor Medical Imaging and Cancer Center class: OTHER briefSummary: Trans arterial chemoembolization (TACE) has emerged as a treatment option for chemotherapy-refractory diseases in Liver metastases. By delivering chemotherapy agents directly to the tumor site, TACE can maximize local drug concentrations and reduce systemic adverse reactions. Bevacizumab is a monoclonal antibody that functions as an angiogenesis inhibitor. It works by slowing the growth of new blood vessels by inhibiting vascular endothelial growth factor A (VEGF-A). The application of Bevacizumab during TACE has not been reported. In this study, we will evaluate the the overall survival (OS)、efficacy, and safety of the application of Bevacizumab during TACE in patients with Liver Metastases by designing an open, single-arm phase II clinical study. conditions: Cancer conditions: Metastatic Cancer conditions: Liver Metastases studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Bevacizumab measure: Overall Survival Rate measure: Objective response rate measure: Adverse event sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06311838 id: 2023H0244 briefTitle: Building Social and Structural Connections for the Prevention of Opioid Use Disorder Among Youth Experiencing Homelessness overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-12 date: 2029-12 date: 2024-03-15 date: 2024-04-09 name: Ohio State University class: OTHER briefSummary: Homelessness severely affects health and well-being and is particularly negative for youth. Between 70-95% of youth experiencing homelessness (YEH) report problem substance use and 66-89% have a mental health disorder. Youth appear to be at greater risk for living on the streets or being homeless than adults and are more vulnerable to long term consequences of homelessness. Multiple social determinants of health (SDOH) are uniquely associated with homelessness, driving substance use and adverse mental health consequences. However, limited research has identified pragmatic interventions that have a long-term ameliorating impact on the complex, multi-symptomatic issues among these youth. This study overcomes prior gaps in research through testing a multi-component comprehensive prevention intervention targeting SDOH that may affect biopsychosocial health indicators and longer-term health outcomes. In partnership with a drop-in center for YEH, youth between the ages of 14 to 24 years, will be engaged and randomly assigned to conditions using a dismantling design so that essential intervention components can be efficiently identified. In particular, youth (N = 300) will be randomly assigned to a) Motivational Interviewing/Community Reinforcement Approach + Services as Usual (MI/CRA + SAU, n = 80), b) Strengths-Based Outreach and Advocacy + Services As Usual (SBOA + SAU, n = 80), c) MI/CRA + SBOA + SAU (n = 80) or d) SAU (n=60) through the drop-in center. In order to assess the longer-term prevention effects on substance use, mental health and other outcomes, all youth will be assessed at baseline and at 3, 6, 12, 18 and 24-months post-baseline. The primary goal of this study is to establish the impact of a comprehensive intervention embedded within a system that serves YEH, a community drop-in center, on youth's opioid misuse and disorder, other substance misuse and disorders, mental health diagnoses, and other targeted outcomes. This study will offer unique information on the physiological and psychological stress pathways underlying change for specific subgroups of youth along with cost estimates to inform future implementation efforts in drop-in centers around the country. conditions: Opioid Use Disorder conditions: Dual Diagnosis conditions: Housing Problems conditions: Mental Disorder in Adolescence conditions: Risk Behavior conditions: Homelessness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Using a dismantling, randomized controlled design, researchers will examine the singular and combined impact of Motivational Interviewing/Community Reinforcement Approach (MI/CRA) and Strengths-Based Outreach and Advocacy (SBOA) on substance use, mental health and other outcomes (e.g., housing stability, education, employment) with Youth Experiencing Homelessness (YEH) recruited from a local drop-in center. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Assessors will be blind to intervention condition. whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Motivational Interviewing/Community Reinforcement Approach (MI/CRA) name: Strengths-Based Outreach and Advocacy (SBOA ) name: Services as Usual (SAU) measure: Form 90 Substance Use interview measure: Shortened Inventory of Problems - Alcohol and Drugs (SIP-AD) measure: Presence of drugs of abuse measure: Beck Depression Inventory II (BDI-II) measure: Beck Anxiety Inventory (BAI) measure: Short Form-12 sex: ALL minimumAge: 14 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT facility: Star House city: Columbus state: Ohio zip: 43201 country: United States name: Natasha Slesnick, PhD role: CONTACT phone: 614-247-8469 email: slesnick.5@osu.edu lat: 39.96118 lon: -82.99879 facility: Ohio State University city: Columbus state: Ohio zip: 43210 country: United States name: Jodi Ford, PhD role: CONTACT phone: 614-292-6862 email: ford.553@osu.edu name: Natasha Slesnick, PhD role: CONTACT phone: (614) 247-8469 email: slesnick.5@osu.edu name: Jodi Ford, PhD role: PRINCIPAL_INVESTIGATOR name: Natasha Slesnick, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06311825 id: IstanbulUCDH briefTitle: The Effect of Horticultural Therapy on Loneliness and Life Satisfaction in Elderly Adults Living in Nursing Home overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-07-31 date: 2024-10-31 date: 2024-03-15 date: 2024-03-15 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: Loneliness in elderly individuals increases with age and negatively affects individuals by decreasing life satisfaction. In recent years, horticultural therapy is a type of therapy that has developed and is added routine care of elderly individuals living in nursing homes. Social interaction, life satisfaction, feelings of success and responsibility and increase while loneliness and depression levels decrease through human-nature interaction in horticultural therapy.

In our country, no study has been found on the effects of horticultural therapy on physical or mental health in elderly individuals. This research will be conducted as a randomized control group study to examine the effects of horticultural therapy on loneliness and life satisfaction in elderly individuals living in nursing homes. conditions: Horticultural Therapy conditions: Loneliness conditions: Satisfaction, Personal conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two parallel groups randomized control study primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 54 type: ESTIMATED name: Horticultural Therapy measure: Loneliness Scale for Elderly measure: Life Satisfaction Scale sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul University - Cerrahpasa (IUC) city: Istanbul state: Şişli country: Turkey name: Hülya Bilgin, PhD role: CONTACT phone: 2122244986 phoneExt: 90 email: hulya.bilgin@iuc.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06311812 id: CREC 2023.683 briefTitle: Retrospective Review on Uterovaginal Anomalies overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2025-02-14 date: 2025-02-14 date: 2024-03-15 date: 2024-03-15 name: Chinese University of Hong Kong class: OTHER briefSummary: Review of surgical outcomes of patient who have undergone surgery for uterovaginal anomalies. Case notes of patients would be reviewed and data would be gathered for statistical analysis. conditions: Abnormalities Uterine conditions: Vaginal Abnormality studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED measure: Incidence of re-stenosis measure: Incidence of re-operation measure: Number of patients with normal menstruation after operation measure: Number of patients with sexual intercourse after operation measure: Number of patients with post-operative infection measure: Number of patients with pregnancy after operation measure: Background demographics affecting post-operative outcomes for patients with uterovaginal anomalies measure: Number of participants with Pre-operative factors affecting post-operative outcomes sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06311799 id: 2024-0102 briefTitle: Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy acronym: FIMPreg overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2025-06-30 date: 2024-03-15 date: 2024-03-15 name: Geisinger Clinic class: OTHER name: Family Health Council of Central Pennsylvania (FHCCP) name: American Heart Association briefSummary: This study is being done to find out if online references to a food management program for Women, Infants, and Children (WIC) made by doctors will get more people to enroll in WIC. Women aged 18 or older who get healthcare at Geisinger, are pregnant, and have one or more heart-related health risks (high blood pressure, diabetes, or obesity) will be asked to join this study. These women need to consent to join this study. There are four groups in this study. Group 1 will get usual care with details about WIC from their doctor. Group 2 will be sent to WIC by their doctor. Group 3 will get details about WIC from their doctor and a dietitian will talk to them about heart-healthy diets and food management. Group 4 will be sent to WIC by their doctor and a dietitian will talk to them about heart-healthy diets and food management. This study will last about 18 months and will have 200 total subjects joining at about 50 per month. Each subject will be in the study for about 6 months. Subjects will be asked to complete surveys at the start and end of the study. Some subjects will also be asked about their experience in the study team after they are done. conditions: Cardiovascular Diseases conditions: Obesity, Maternal conditions: Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: WIC Referral name: RDN Referral measure: Difference in WIC enrollment measure: WIC retention measure: WIC adherence measure: Prenatal clinic visit adherence. measure: RDN visit adherence sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06311786 id: 257HV107 briefTitle: A Study to Look at How a Single Oral Dose of Carbon-14-Labelled [14C] BIIB091 Moves Through and is Processed by the Body in Healthy Male Participants acronym: Mass Balance overallStatus: NOT_YET_RECRUITING date: 2024-04-09 date: 2024-05-13 date: 2024-05-13 date: 2024-03-15 date: 2024-03-15 name: Biogen class: INDUSTRY briefSummary: The main goal of this study is to learn how \[14C\]-BIIB091 moves through and is processed by the body and to look at how much of BIIB091's metabolites (what is produced when BIIB091 is broken down by the body) appears in the blood, urine, and stool in healthy male participants. The study will also help researchers learn more about the safety of BIIB091 in healthy male participants. conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: [14C]-BIIB091 measure: Amount of BIIB091 Excreted per Sampling Interval in Urine (Aeu) measure: Amount of BIIB091 Excreted per Sampling Interval in Feces (Aef) measure: Cumulative Amount of BIIB091 Excreted per Sampling Interval in Urine (Cum Aeu) measure: Cumulative Amount of BIIB091 Excreted per Sampling Interval in Feces (Cum Aef) measure: Percentage of BIIB091 Excreted per Sampling Interval in Urine (%Feu) measure: Percentage of BIIB091 Excreted per Sampling Interval in Feces (%Fef) measure: Cumulative Percentage of BIIB091 Excreted in Urine (Cum %Feu) measure: Cumulative Percentage of BIIB091 Excreted in Feces (Cum %Fef) measure: Maximum Observed Concentration (Cmax) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood measure: Time to Reach Maximum Observed Concentration (Tmax) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood measure: Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood measure: Terminal Half-Life (t1/2) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood measure: Apparent Clearance (CL/F) of BIIB091 in Plasma measure: Apparent Volume of Distribution (Vz/F) of BIIB091 in Plasma measure: Quantitative Profile of [14C]-BIIB091 Metabolites in Plasma measure: Quantitative Profile of [14C]-BIIB091 Metabolites in Urine measure: Quantitative Profile of [14C]-BIIB091 Metabolites in Feces measure: Cmax of Plasma Metabolite 23 (M23) measure: Tmax of Plasma M23 measure: AUClast of Plasma M23 measure: AUCinf of Plasma M23 measure: t1/2 of Plasma M23 measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters measure: Number of Participants With Clinically Significant Vital Sign Abnormalities measure: Number of Participants With Clinically Significant Physical Examination Abnormalities measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities as Assessed by 12-Lead ECG Measurements measure: Number of Participants With Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06311773 id: Protocol # 24-01 briefTitle: Pivotal Trial of the Boomerang Catheter for pDVA overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-01-15 date: 2029-01-15 date: 2024-03-15 date: 2024-03-15 name: Aveera Medical, Inc. class: INDUSTRY briefSummary: The purpose of this study is to establish the safety and effectiveness of the Boomerang Catheter for percutaneous Deep Venous Arterialization (pDVA) to treat no-option Chronic Limb-Threatening Ischemia. conditions: Chronic Limb-Threatening Ischemia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Boomerang Catheter measure: Amputation Free Survival (AFS) measure: Technical success measure: Procedural success measure: Limb salvage measure: Primary patency measure: Primary assisted patency measure: Secondary patency measure: Target wound healing measure: Complete wound healing sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06311760 id: D7700C00001 briefTitle: A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 In Healthy Participants overallStatus: RECRUITING date: 2024-04-09 date: 2024-09-24 date: 2024-09-24 date: 2024-03-15 date: 2024-04-18 name: AstraZeneca class: INDUSTRY briefSummary: This study will assess the safety, tolerability and pharmacokinetics (PK) of AZD0292 following intravenous (IV) administration of single ascending doses to healthy adult participants. conditions: Healthy Participants Study studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 24 type: ESTIMATED name: AZD0292 name: Placebo measure: Number of Participants with Adverse Events measure: Number of Participants with Adverse Events of Special Interest (AESI) measure: Maximum Observed Drug Concentration (Cmax) measure: Area Under Concentration-Curve from Time Zero to the Last Quantifiable Concentration (AUClast) measure: Area Under Concentration-Time Curve from Time Zero to Infinity (AUCinfinity) measure: Number of Participants with Positive Anti-drug Antibodies (ADAs) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Research Site status: RECRUITING city: Baltimore state: Maryland zip: 21225 country: United States lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06311747 id: 24-1T/45 briefTitle: The Effect of Oculomotor Exercises in the Warm-up on Forehand and Backhand Stroke Performance in Tennis Players overallStatus: RECRUITING date: 2024-01-15 date: 2024-07 date: 2024-09 date: 2024-03-15 date: 2024-03-20 name: Ege University class: OTHER briefSummary: 30 tennis players aged 12-18, will be included in the study. After their normal warm-up, the participants will make 30 forehand and 30 backhand strokes. Forehand and backhand stroke accuracy rate will be calculated. After a week, additional oculo-motor exercises will be included in the warm-up and the forehand and backhand stroke accuracy rate will be calculated again. The hypothesis that there will be an improvement in forehand and backhand stroke accuracy after oculo-motor exercises will be tested. conditions: Supportive Care studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: Oculo-motor exercises measure: Forehand and backhand stroke accuracy sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Ege University Sports Medicine Clinic status: RECRUITING city: İzmir state: Bornova zip: 35100 country: Turkey name: Cim CINAR role: CONTACT phone: 905375213611 email: cimcinar95@gmail.com lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06311734 id: LW231-I-01 briefTitle: A Study of LW231 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection overallStatus: ACTIVE_NOT_RECRUITING date: 2021-11-01 date: 2024-04-01 date: 2024-05-01 date: 2024-03-15 date: 2024-03-15 name: Shanghai Longwood Biopharmaceuticals Co., Ltd. class: INDUSTRY briefSummary: To Evaluate the Tolerability and Pharmacokinetics of LW231 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects . conditions: Chronic Hepatitis B studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: LW231 tablets name: Placebo measure: Number of Participants With Adverse Events (AEs) measure: Maximum Plasma Concentration (Cmax) of LW231 measure: Time to Cmax (Tmax) of LW231 measure: Area Under the Curve From Time 0 to the Last Measurable Concentration (AUClast) of LW231 measure: Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of LW231 measure: Half-life (t1/2) of LW231 sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: The First Hospital of Jilin University city: Changchun state: Jilin country: China lat: 43.88 lon: 125.32278 hasResults: False

 nctId: NCT06311721 id: 20210033 id: 2023-508336-57 type: EUDRACT_NUMBER briefTitle: A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-19 date: 2027-10-22 date: 2027-10-22 date: 2024-03-15 date: 2024-04-02 name: Amgen class: INDUSTRY briefSummary: The primary objective of this study is to compare the efficacy of ABP 234 with the pembrolizumab reference product (Keytruda®). conditions: Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 927 type: ESTIMATED name: ABP 234 name: Pembrolizumab (US) name: Pembrolizumab (EU) measure: Objective response (OR) measure: Area under the serum concentration-time curve (AUC) from time 0 to 21 days (AUC21d) of ABP 234 measure: AUC at steady state between Week 16 and Week 19 (AUCtau_ss) of ABP 234 measure: OR measure: OR measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Maximum observed serum concentration following the first dose (Cmax_dose1) of ABP 234 measure: Cmax_dose1 of pembrolizumab (US) measure: Cmax_dose1 of pembrolizumab (EU) measure: Time to maximum concentration following the first dose (tmax_dose1) of ABP 234 measure: Tmax_dose1 of pembrolizumab (US) measure: Tmax_dose1 of pembrolizumab (EU) measure: Maximum observed serum concentration (Cmax) at steady state (Cmax_ss) of ABP 234 measure: Cmax_ss of pembrolizumab (US) measure: Cmax_ss of of pembrolizumab (EU) measure: Time to maximum concentration at steady state (tmax_ss) of ABP 234 measure: Tmax_ss of pembrolizumab (US) measure: Tmax_ss of pembrolizumab (EU) measure: Trough serum concentrations at pre-dose of week 4 (Ctrough_w4) of ABP 234 measure: Ctrough_w4 of pembrolizumab (US) measure: Ctrough_w4 of pembrolizumab (EU) measure: Trough serum concentrations at steady state (Ctrough_ss) at pre-dose of ABP 234 measure: Ctrough_ss at pre-dose of pembrolizumab (US) measure: Ctrough_ss at pre-dose of pembrolizumab (EU) measure: AUC21d of pembrolizumab (US) measure: AUC21d of pembrolizumab (EU) measure: AUCtau_ss of pembrolizumab (US) measure: AUCtau_ss pembrolizumab (EU) measure: Number of participants who experience a Treatment-emergent adverse event measure: Number of participants who experience a Treatment-emergent serious adverse event measure: Number of participants who experience a Treatment-emergent adverse event of interest measure: Number of participants who experience anti-drug antibodies (ADA) sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06311708 id: TN-401-0011 briefTitle: Non-interventional Study of Seroprevalence of Pre-existing Antibodies Against Adenovirus-associated Virus Vector (AAV9) and the Progression of Disease in Patients With Plakophilin 2 (PKP2)-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) acronym: RIDGE overallStatus: RECRUITING date: 2023-01-31 date: 2030-03-29 date: 2030-07-11 date: 2024-03-15 date: 2024-03-15 name: Tenaya Therapeutics class: INDUSTRY name: University of California, San Francisco name: Brigham and Women's Hospital name: New York University name: University of Colorado, Denver name: Johns Hopkins University name: The Cleveland Clinic name: Mayo Clinic name: Medical University of South Carolina name: Hopital Louis Pradel name: Istituti Clinici Scientifici Maugeri SpA name: The Queen Elizabeth Hospital name: St George's University Hospitals NHS Foundation Trust name: Royal Brompton & Harefield NHS Foundation Trust name: Barts & The London NHS Trust briefSummary: This is a multicenter, non-interventional study to observe the natural progression of the disease and to study the prevalence of pre-existing antibodies to AAV9 used for gene therapy in a population of patients with PKP2 gene-associated ARVC. Participation from all patients is encouraged regardless of interest in or eligibility for gene therapy. conditions: Arrhythmogenic Right Ventricular Cardiomyopathy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 200 type: ESTIMATED measure: Investigate the seroprevalence of pre-existing antibodies to AAV9 in patients with PKP2-associated ARVC measure: To characterize the burden of illness in patients with pathogenic or likely pathogenic PKP2 mutations measure: To characterize arrhythmic risk in patients with pathogenic or likely pathogenic PKP2 mutations measure: To evaluate functional status and Quality of Life (QoL) in patients with pathogenic or likely pathogenic PKP2 mutations measure: To evaluate heart function as assessed by imaging in patients with pathogenic or likely pathogenic PKP2 mutations measure: • To monitor biomarkers associated with disease progression and inflammation in patients with pathogenic or likely pathogenic PKP2 mutations measure: To evaluate genetics associated with PKP2-associated ARVC measure: To evaluate the effect of other cardiac mutations or other genetic variants that might affect the penetrance and/or expressivity of PKP2 mutations in patients with pathogenic or likely pathogenic PKP2 mutations measure: To evaluate health care utilization in patients with pathogenic or likely pathogenic PKP2 mutations sex: ALL minimumAge: 14 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of California San Francisco status: RECRUITING city: San Francisco state: California zip: 94143 country: United States name: Vasanth Vedantham, MD, PhD role: CONTACT lat: 37.77493 lon: -122.41942 facility: University of Colorado, Denver status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Matthew Taylor, MD, PhD role: CONTACT lat: 39.72943 lon: -104.83192 facility: John Hopkins University School of Medicine status: RECRUITING city: Baltimore state: Maryland zip: 21287 country: United States name: Hugh G Calkins, MD role: CONTACT lat: 39.29038 lon: -76.61219 facility: Brigham and Women's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Neal Lakdawala, MD role: CONTACT lat: 42.35843 lon: -71.05977 facility: Mayo Clinic status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: John Giudicessi, MD PhD role: CONTACT lat: 44.02163 lon: -92.4699 facility: New York University status: RECRUITING city: New York state: New York zip: 10016 country: United States name: Larry Chinitz, MD role: CONTACT lat: 40.71427 lon: -74.00597 facility: Cleveland Clinic status: RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States name: Wai Hong Wilson Tang, MD role: CONTACT lat: 41.4995 lon: -81.69541 facility: Medical University of South Carolina status: RECRUITING city: Charleston state: South Carolina zip: 29425 country: United States name: Daniel Judge, MD role: CONTACT lat: 32.77657 lon: -79.93092 facility: Hopital Louis Pradel status: RECRUITING city: Bron country: France name: Philippe Chevalier, MD, PhD role: CONTACT lat: 45.73333 lon: 4.91667 facility: Istituti Clinici Scientifici Maugeri SpA status: RECRUITING city: Pavia country: Italy name: Silvia Priori, MD, PhD role: CONTACT lat: 45.19205 lon: 9.15917 facility: The Queen Elizabeth Hospital status: RECRUITING city: Glasgow zip: G514TF country: United Kingdom name: Caroline Coats, MD role: CONTACT lat: 55.86515 lon: -4.25763 facility: Barts & The London Health NHS Trust status: RECRUITING city: London zip: E1 1BB country: United Kingdom name: Perry Elliott, MD role: CONTACT lat: 51.50853 lon: -0.12574 facility: St. George's University Hospitals NHS Foundation Trust status: RECRUITING city: London zip: SW17 0QT country: United Kingdom name: Elijah Behr, MD role: CONTACT lat: 51.50853 lon: -0.12574 facility: Royal Brompton & Harefield NHS Foundation Trust status: RECRUITING city: London zip: SW3 6NP country: United Kingdom name: Antonio Pantazis, MD role: CONTACT lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06311695 id: IEO 960 briefTitle: Contrast-Enhanced Spectral Mammography (CESM) acronym: CESM overallStatus: ACTIVE_NOT_RECRUITING date: 2012-01-01 date: 2022-02-28 date: 2024-12-31 date: 2024-03-15 date: 2024-03-15 name: European Institute of Oncology class: OTHER briefSummary: The study's objective is to compare the diagnostic accuracy of the contrast-enhanced mammography (CEM) , considering as reference the classification obtained with Vacuum Assisted Breast Biopsy (VABB). conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 325 type: ACTUAL name: Contrast Enhanced Mammography measure: Evaluation of negative predictive value (NPV) of the CEM measure: Evaluation of sensitivity of CEM measure: Evaluation of specificity of CEM measure: Positive Predictive Value (PPV) of CEM sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Breast Imaging Division, Radiology Department, IEO European Institute of Oncology IRCCS city: Milan zip: 20141 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06311682 id: LP0162-1336 id: U1111-1285-6559 type: OTHER domain: World Health Organization (WHO) id: 2023-503630-44 type: OTHER domain: European Medicines Agency (EMA) briefTitle: A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis acronym: TRAPEDS 2 overallStatus: NOT_YET_RECRUITING date: 2024-05-24 date: 2026-03-26 date: 2028-04-28 date: 2024-03-15 date: 2024-03-15 name: LEO Pharma class: INDUSTRY briefSummary: The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections \[SC\]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis and its symptoms, as well as general health status and quality of life. The trial will last for up to 4 years. There will be visits every 2 weeks for the first year and every 6 weeks thereafter. Some of the visits will be conducted by phone.

The study involves two different age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. This trial compares tralokinumab +TCS to placebo + TCS for children with moderate-to-severe AD and evaluates tralokinumab + TCS for infants with moderate-to-severe AD. Infants will not receive placebo. All subjects will go through a screening process, which is the first part of the trial and will last up to 4 weeks. During this period, it will be checked if the child or infant meets the criteria to participate in the trial.

The children will be randomly assigned to receive tralokinumab + TCS or placebo + TCS for the initial 16 weeks, with the treatment being double-blinded. During the first 16 weeks, children will have a 2 out of 3 chance of getting tralokinumab and a 1 out of 3 chance of getting placebo. Thereafter, all subjects will receive tralokinumab + TCS. The infants will receive tralokinumab + TCS as open-label treatment for the entire treatment period, meaning that the participants will know they are receiving tralokinumab. After stopping treatment, all participants will enter a 4-week safety follow-up period. conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study design is parallel for children and a single group for infants. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: For subjects aged 2 to \<12 years at screening, the trial is double-blind to ensure an objective evaluation of efficacy and safety of the Investigational Medicinal Product (IMP). The subject, the subject's caregiver(s), and the investigator involved in the clinical evaluation and monitoring of the subjects will not be aware of the treatment from baseline to Week 16. However, the site staff that responsible for administering tralokinumab will be aware of the treatment allocation as tralokinumab is visibly different from placebo and has a higher viscosity, requiring more pressure to depress the plunger during injections. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 195 type: ESTIMATED name: Tralokinumab + TCS name: Placebo + TCS measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening. measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening. measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening. measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening. measure: Having at least 50% reduction in EASI score in subjects aged 2 to <12 years at screening. measure: Having at least 50% reduction in EASI score in subjects aged 6 month to <2 years at screening. measure: Percent change in EASI in subjects aged 2 to <12 years at screening. measure: Percent change in EASI in subjects aged 6 month to <2 years at screening. measure: Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 2 to <12 years at screening. measure: Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 6 month to <2 years at screening. measure: Percent change in affected BSA in subjects aged 2 to <12 years at screening. measure: Percent change in affected BSA in subjects aged 6 month to <2 years at screening. measure: Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening. measure: Reduction in Child Worst Itch numeric rating score (NRS) (weekly average) ≥4 for subjects aged 6 to <12 years at screening. measure: Reduction in Scratch Observer-Reported Outcome (ObsRO) (weekly average) ≥4 for subjects aged 2 to <6 years at screening. measure: Reduction in Scratch Observer-Reported Outcome (ObsRO) (weekly average) ≥4 for subjects aged 6 months to <2 years years at screening. measure: Reduction of ≥4 in Child Worst Itch NRS (weekly average) for subjects aged 6 to <12 years at screening or Scratch ObsRO (weekly average) for subjects aged 2 to <6 years at screening. measure: Percent change in Patient-Oriented Eczema Measure (POEM) in subjects aged 2 to <12 years at screening. measure: Percent change in Patient-Oriented Eczema Measure (POEM) in subjects aged 6 month to <2 years at screening. measure: Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 2 to <12 years at screening. measure: Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 6 month to <2 years at screening. measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening. measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening. measure: Change in Child Worst Itch NRS (weekly average) for subjects aged 6 to <12 years at screening. measure: Change in Scratch Observer-Reported Outcome (ObsRO) (weekly average) in subjects aged 2 to <6 years at screening. measure: Change in Scratch Observer-Reported Outcome (ObsRO) (weekly average) in subjects aged 6 month to <2 years at screening. measure: Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥6 for subjects aged 4 to <12 years at screening. measure: Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening. measure: Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening. measure: Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 2 to <12 years at screening. measure: Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 6 month to <2 years at screening. measure: Rescue treatment use (yes/no) in subjects aged 2 to <12 years at screening. measure: Rescue treatment use (yes/no) in subjects aged 6 month to <2 years at screening. measure: Number of TCS free days in subjects aged 2 to <12 years at screening. measure: Number of TCS free days in subjects aged 6 month to <2 years at screening. measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening. measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening. measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening. measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening. measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. measure: Percent change in EASI in subjects aged 2 to <12 years at screening. measure: Percent change in EASI in subjects aged 6 month to <2 years at screening. measure: Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 2 to <12 years at screening. measure: Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 6 month to <2 years at screening. measure: Percent change in affected body surface area (BSA) in subjects aged 2 to <12 years at screening. measure: Percent change in affected body surface area (BSA) in subjects aged 6 month to <2 years at screening. measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening. measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening. measure: Percent change in Children's Dermatology Life Quality Index (CDLQI) in subjects aged 4 to <12 years at screening. measure: Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥6 for subjects aged 4 to <12 years at screening. measure: Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 2 to <12 years at screening. measure: Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 6 month to <2 years at screening. measure: Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening. measure: Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening. measure: Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 2 to <12 years at screening. measure: Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 6 month to <2 years at screening. measure: Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening. measure: Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening. measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening. measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening. measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening. measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening. measure: Percent change in EASI in subjects aged 2 to <12 years at screening. measure: Percent change in EASI in subjects aged 6 month to <2 years at screening. measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening. measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening. measure: Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening. measure: Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening. measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening. measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening. measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening. measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening. measure: Percent change in EASI in subjects aged 2 to <12 years at screening. measure: Percent change in EASI in subjects aged 6 month to <2 years at screening. measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening. measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening. measure: Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening. measure: Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening. measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening. measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening. measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening. measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening. measure: Percent change in EASI in subjects aged 2 to <12 years at screening. measure: Percent change in EASI in subjects aged 6 month to <2 years at screening. measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening. measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening. measure: Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening. measure: Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening. sex: ALL minimumAge: 6 Months maximumAge: 11 Years stdAges: CHILD hasResults: False

 nctId: NCT06311669 id: 29409010104798 briefTitle: Comparative Study Between Isolated Iliac Vein Stenting Versus Concomitant Iliac Vein Stenting With Pelvic Vein Embolization in Patients With Pelvic Venous Insufficiency Secondary to Nonthrombotic Iliac Vein Lesions overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-01 date: 2025-03 date: 2025-03 date: 2024-03-15 date: 2024-03-15 name: Ain Shams University class: OTHER briefSummary: The aim of the study is to compare between Isolated Iliac vein stenting vs Concomitant Iliac vein stenting with pelvic vein embolization in patients with Pelvic Venous Insufficiency secondary to Nonthrombotic iliac vein lesions conditions: Nonthrombotic Iliac Vein Lesions conditions: Pelvic Congestive Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: iliac vein stenting name: pelvic vein embolization measure: Clinical improvement of pain and pelvic symptoms according to the Pelvic Venous Clinical Severity Score (PVCSS) sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Ainshams University city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06311656 id: 18840 id: J5C-MC-FOAA type: OTHER domain: DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company briefTitle: A Study to Evaluate Safety, Tolerability of LY4100511 (DC-853) in Healthy Asian and Non-Asian Participants overallStatus: NOT_YET_RECRUITING date: 2024-03-12 date: 2024-05-30 date: 2024-05-30 date: 2024-03-15 date: 2024-03-15 name: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company class: INDUSTRY name: Eli Lilly and Company briefSummary: The main purpose of this study is to assess the safety and tolerability of LY4100511 (DC-853) after single and multiple dose administrations in healthy asian participants and non-Asian participants. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: LY4100511 (DC-853) name: Placebo measure: Number of participants with one or more Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4100511 (DC-853) measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4100511 (DC-853) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Altasciences Clinical Los Angeles, Inc city: Cypress state: California zip: 90630 country: United States lat: 33.81696 lon: -118.03729 hasResults: False

 nctId: NCT06311643 id: 35 briefTitle: Ameliorative Potential of Relaxing Back Massage on Puerperial Women's Hormones and Infant Weight overallStatus: COMPLETED date: 2023-03-02 date: 2023-09-01 date: 2024-03-01 date: 2024-03-15 date: 2024-03-15 name: Kafrelsheikh University class: OTHER briefSummary: Effect of massage on hormone levels in puerperal women conditions: Does Postpartum Massage Affect Leptin, Prolactin and Growth Hormone studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Puerperal woman aged from 25 to 30 years within 4 hours of normal delivery primaryPurpose: HEALTH_SERVICES_RESEARCH masking: QUADRUPLE maskingDescription: the assessor and statistician remained blinded throughout the assessment period, unaware of the group assignments. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ACTUAL name: Postpartum back massage in study group measure: Leptin and prolactin levels increase sex: FEMALE minimumAge: 25 Years maximumAge: 30 Years stdAges: ADULT facility: Kafrelshiekh university city: Kafrelshiekh zip: 6850001 country: Egypt hasResults: False

 nctId: NCT06311630 id: 65/23/IEC/JMMC&RI briefTitle: Comparative Study of Analgesic Effect of Ultrasound Guided PENG Block vs FEMORAL BLOCK in Hip Fracture overallStatus: RECRUITING date: 2023-05-20 date: 2025-01-20 date: 2025-03-20 date: 2024-03-15 date: 2024-03-15 name: Jubilee Mission Medical College and Research Institute class: OTHER briefSummary: To study the analgesic effect of ultrasound guided PENG Block vs Femoral nerve block in patients with Hip fracture presenting to Emergency department conditions: Hip Fracture studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 70 type: ESTIMATED measure: Comparative Study of Analgesic Effect of Ultrasound Guided PENG Block With FEMORAL NERVE BLOCK in Patients With Hip Fracture as assessed by NRS pain scoring scale by patient measure: Time taken for each technique measure: Time taken for adequate analgesia measure: Incidence of complications measure: To note if rescue analgesic is required sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jubilee mission medical College and research centre status: RECRUITING city: Thrissur state: Kerala zip: 680005 country: India name: Jogi Varghese, MBBS role: CONTACT phone: 9947004222 email: jogi1907@gmail.com lat: 10.51667 lon: 76.21667 hasResults: False

 nctId: NCT06311617 id: 231592 briefTitle: Retinal Vascular Changes During Pregnancy overallStatus: RECRUITING date: 2024-02-01 date: 2027-01 date: 2027-01 date: 2024-03-15 date: 2024-03-15 name: Vanderbilt University Medical Center class: OTHER briefSummary: The goal of this study is to better understand how the back part of the eye-called the retina and the choroid-changes during pregnancy. Specialized photos of the eye will be taken at three different timepoints: early in pregnancy (first or second trimester), late in pregnancy (third trimester), and after delivery. This imaging is non-invasive and does not require contact with the surface of the eye. The photos taken will allow assessment of specific parameters, like blood flow and the health of specialized cells that support vision. Understanding how the eyes change during pregnancy may help guide how retina specialists understanding of retinal disease during pregnancy and better inform pregnancy outcomes. conditions: Pregnancy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 90 type: ESTIMATED name: Fundus photography and optical coherence tomography measure: Imaging Biomarkers: Choroid measure: Imaging Biomarkers: Vessel density measure: Imaging Biomarkers: Foveal avascular zone (FAZ) measure: Fetal Health: delivery measure: Fetal Health sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vanderbilt University Medical Center status: RECRUITING city: Nashville state: Tennessee zip: 37232 country: United States name: Avni Finn, MD, MBA role: CONTACT phone: 615-936-1639 lat: 36.16589 lon: -86.78444 hasResults: False

 nctId: NCT06311604 id: 38RC22.0272 briefTitle: Evaluation of the Safety of Inhaled Sedation With Isoflurane in Head Trauma Patients acronym: IsoSAFE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-12-01 date: 2024-03-15 date: 2024-03-15 name: University Hospital, Grenoble class: OTHER briefSummary: Intensive care management of patient with severe traumatic brain injury (TBI) includes deep and prolonged sedation with intravenous hypnotics (propofol, midazolam, ketamine) in combination with opioids to prevent and/or treat episodes of intracranial hypertension. However, some patients may develop tachyphylaxis with a gradual increase of administered intravenous hypnotics and opioids to maintain the same level of sedation. This situation leads to a failure in controlling intracranial pressure (ICP) and/or to the risk of adverse effects due to high-dose sedatives: haemodynamic instability, prolonged mechanical ventilation, neuromyopathy, delirium, withdrawal syndrome.

Halogenated agents (Isoflurane, Sevoflurane) are a class of hypnotics routinely used in the operating room. However, doses used in surgical patients (\> 1 Minimal Alveolar Concentration, MAC) are not suitable in neuro-intensive care unit (ICU) patients at risk of intracranial hypertension because of the cerebral vasodilator effects of halogenated agents at this dosage, hence the risk of high ICP and compromised cerebral perfusion pressure.

The use of halogenated agents has been recently possible in the ICU through dedicated medical devices (Sedaconda ACD, Mirus). Recommended dosage are lower in the ICU, i.e. 0.3-0.7 MAC, because of their association with intravenous hypnotics and the absence of surgical stimuli. Several clinical studies in general ICUs showed improved sedation quality, reduced duration of mechanical ventilation, faster arousal and shorter extubation time, and lower costs in halogenated group compared with control group receiving midazolam or propofol. At low doses, the effects on ICP and intracerebral haemodynamics of halogenated agents are minor according to the available literature. In addition, beneficial effects were found on cerebral ischaemic volume in animal models treated with halogenated agents. However, there is a need to explore the benefit-risk ratio of the use of halogenated agents in the severe TBI population.

The investigator hypothesise that 0.7 MAC Isoflurane can be administered in this population without deleterious effect on ICP. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, open-label, single-centre, interventional dose escalation study primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Isoflurane measure: To assess the safety of sedation with 0.7 MAC of inhaled isoflurane in cranial trauma patients in terms of intracranial pressure. measure: To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma. measure: To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma. measure: To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma. measure: To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma. measure: To assess the extra-neurological effects of inhaled isoflurane sedation in head trauma patients measure: To assess the extra-neurological effects of inhaled isoflurane sedation in head trauma patients measure: To assess the extra-neurological effects of inhaled isoflurane sedation in head trauma patients measure: To assess the savings in intravenous hypnotics associated with isoflurane inhalation sedation in head trauma patients measure: To assess the feasibility of inhaled sedation with isoflurane in patients with head trauma measure: To assess the neurological outcome at D28 after inhaled sedation in head trauma patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Grenoble city: Grenoble state: Choisir Une Région zip: 38043 country: France name: barthélémy H Grenoble, MD role: CONTACT phone: +33476766879 email: bbertrand4@chu-grenoble.fr name: Anais ADOLLE role: CONTACT phone: +33476766879 email: aadolle@chu-grenoble.fr lat: 45.16667 lon: 5.71667 hasResults: False

 nctId: NCT06311591 id: STUDY00000716 Part B id: 1P50MH129701 type: NIH link: https://reporter.nih.gov/quickSearch/1P50MH129701 briefTitle: Efficacy, Effectiveness, and Implementation of Jaspr Health in Emergency Department- Part B acronym: Jaspr-PartB overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-04-01 date: 2027-04-01 date: 2024-03-15 date: 2024-03-28 name: University of Massachusetts, Worcester class: OTHER name: Ohio State University name: University of Colorado, Denver name: Evidence-Based Practice Institute, Seattle, WA name: National Institute of Mental Health (NIMH) name: Worcester Polytechnic Institute briefSummary: This Study will evaluate the implementation of a multi-component suicide prevention technology (Jaspr Health) that facilitates delivery of suicided-related evidence-based practices (EBPs) while replacing wasted waiting time with productive time in the Emergency Departments (EDs). The EBPs satisfy several key performance elements for systems adopting Zero Suicide.

A Complementary Randomized Controlled Trial and Real-World Study for Efficacy, Effectiveness, and Implementation Study Design (CREID) will be used conditions: Suicidal Ideation conditions: Suicide Attempt conditions: Self Harm studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 27908 type: ESTIMATED name: Jaspr App measure: Suicide composite, binary measure: Evidence-Based Practice (EBP) delivery measure: Patient reach measure: Fidelity measure: Exposure, Time measure: Costs measure: Clinician acceptability measure: Patient acceptability measure: Feasibility of Jaspr in ED measure: Usability (clinician) measure: System workflow impact, door to behavioral health evaluation measure: System workflow impact, total length of stay measure: System workflow impact, 28 day revisit measure: System workflow impact, clinician perception sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCHealth University of Colorado Hospital city: Aurora state: Colorado zip: 80045 country: United States name: Marian Betz, MD role: CONTACT email: marian.betz@cuanschutz.edu lat: 39.72943 lon: -104.83192 facility: UCHealth Memorial Hospital Central city: Colorado Springs state: Colorado zip: 80909 country: United States name: Marian Betz, MD role: CONTACT email: marian.betz@cuanschutz.edu lat: 38.83388 lon: -104.82136 facility: Ohio State East Hospital city: Columbus state: Ohio zip: 43210 country: United States name: Michael S Lyons, MD role: CONTACT email: michael.lyons@osumc.edu lat: 39.96118 lon: -82.99879 facility: The Ohio State University Wexner Medical Center city: Columbus state: Ohio zip: 43210 country: United States name: Michael S Lyons, MD role: CONTACT email: michael.lyons@osumc.edu lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06311578 id: 87704916LUC1001 id: 2023-506495-27-00 type: REGISTRY domain: EUCT number briefTitle: A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors overallStatus: RECRUITING date: 2024-04-10 date: 2028-11-08 date: 2033-11-30 date: 2024-03-15 date: 2024-04-25 name: Johnson & Johnson Enterprise Innovation Inc. class: INDUSTRY briefSummary: The purpose of this study is to determine the safety, feasibility, recommended dose(s) and regimen(s) of JNJ-87704916 as monotherapy and in combination with cetrelimab. conditions: Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 66 type: ESTIMATED name: JNJ-87704916 name: Cetrelimab measure: Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) measure: Number of Participants with Adverse Events (AEs) by Severity measure: Parts 1 and 2: Percentage of Participants With Objective Response (OR) measure: Parts 1 and 2: Percentage of Participants With Disease Control (DC) measure: Parts 1 and 2: Duration of Response (DOR) measure: Part 2: Progression Free Survival (PFS) measure: Part 2: Overall Survival (OS) measure: Parts 1 and 2: Number of JNJ-87704916 Genome Copies per Milliliter measure: Parts 1 and 2: Payload Concentrations of JNJ-87704916 measure: Parts 1 and 2: Number of Participants with JNJ-87704916 Antibodies sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center status: RECRUITING city: Houston state: Texas zip: 77030 country: United States lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06311565 id: SBU-ISTANBUL-0001 briefTitle: Effects of Education After Colorectal Cancer Screening overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-10-30 date: 2024-12-30 date: 2024-03-15 date: 2024-03-15 name: Istanbul Saglik Bilimleri University class: OTHER briefSummary: The aim of this study is to examine the effect of the education given to individuals undergoing colorectal cancer screening on their attitudes, beliefs and healthy lifestyle behaviors.

This study was planned to be conducted as a prospective randomized controlled study in a family health center in Istanbul. The universe of the research; The sample of individuals registered to the family health center will consist of a total of 70 individuals who meet the inclusion criteria for the study.

Patient Diagnosis Form, Colorectal Cancer Screening Attitude Belief Scale, Healthy Lifestyle Behavior Scale II will be used to collect data. Data will be collected at the first encounter, 1 month later, 3 months later, pre-test and post-test. In the research, individuals will be divided into two groups: intervention (n = 35) and control (n = 35). Training will be provided to the intervention group. conditions: Healthy Lifestyle conditions: Education studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled ( experimental and control group) primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 70 type: ESTIMATED name: Education measure: Colorectal cancer screening attitude belief scale measure: Healthy lifestyle behaviors scale II sex: ALL minimumAge: 50 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hilal KARTAL city: Istanbul state: Beylikdüzü country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06311552 id: 0856 briefTitle: Optimising CMR Scan Acquisitions for Novel Equipment/Sequences in Clinical Cardiovascular Populations. acronym: OPTMISE-HFpEF overallStatus: COMPLETED date: 2022-01-31 date: 2023-11-30 date: 2023-11-30 date: 2024-03-15 date: 2024-03-15 name: University of Leicester class: OTHER briefSummary: The purpose of this study is to develop robust protocols for the optimisation of novel hardware, software and exercise equipment in the magnetic resonance imaging (MRI) environment in various cohorts with cardiovascular disease (CVD) with the first study focusing on those with established heart failure with preserved ejection fraction (HFpEF) or those at risk of or with pre-HFpEF. conditions: Heart Failure With Preserved Ejection Fraction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 30 type: ACTUAL name: Participants will undergo a comprehensive CMR scan on either a 1.5- or 3-Tesla scanner measure: To develop CMR scanning protocols which acquire the highest quality images during incremental exercise using a stepper ergometer (Ergospect Cardio-stepper). measure: To determine the reproducibility of the exercise CMR protocols in a test-retest reproducibility sub-study measure: To determine the optimal scan acquisition protocol for Magnetic Resonance Spectroscopy (MRS) both H+ and 31P using the phosphorous coil in each patient group. measure: To determine the reproducibility of the MRS protocols in a test-retest reproducibility sub-study sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Glenfield Hospital city: Leicester country: United Kingdom lat: 52.6386 lon: -1.13169 hasResults: False

 nctId: NCT06311539 id: IstanbulBUFC4 briefTitle: The Effect of Circadian Rhythm on Physical Performance in Healthy Male Individuals overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-01 date: 2024-10-01 date: 2024-03-15 date: 2024-03-15 name: Istanbul Bilgi University class: OTHER briefSummary: Little is known about optimizing the timing of exercise periods to maximize the health benefits of exercise. Furthermore, exercise is a potent modulator of skeletal muscle metabolism and it is clear that skeletal muscle has a robust circadian profile. Circadian rhythms can be observed in behavior, physiology, and metabolism. Various studies show that exercise changes the rhythm of the clock machines in skeletal muscle. Studies examining the relationship between exercise, especially strength training, and circadian rhythm are quite limited in the literature. Although some studies have shown that force peaks in the afternoon/evening hours, regardless of muscle group and contraction speed, there are no studies on how much this time interval varies from person to person and chronotype.

The aim of this study is to investigate to what extent strength training given at appropriate times for morning, evening and intermediate chronotypes creates changes in performance in healthy adult male individuals. conditions: Chronotype conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Study primaryPurpose: SCREENING masking: SINGLE maskingDescription: The evaluator who will perform isokinetic assessments and vertical jump measurements will be blinded to the participants' chronotype. whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Theraband Strengthening Exercise Program measure: Isokinetic strength test measure: Vertical jump test sex: MALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT hasResults: False

 nctId: NCT06311526 id: 24C303 briefTitle: Mechanism of Action of Focal Extracorporeal Shock Waves as a Treatment of Upper Limb Stroke Spasticity: a Pilot Study acronym: SASHA overallStatus: RECRUITING date: 2023-05-30 date: 2025-04-30 date: 2025-04-30 date: 2024-03-15 date: 2024-03-15 name: Istituto Auxologico Italiano class: OTHER briefSummary: Spasticity, common after a stroke, aggravates the patient's motor impairment causing pain and limitation in daily activities such as eating, dressing and walking.

There are different spasticity treatments, such as botulinum neurotoxin, in the first place. Among the emerging therapies is focal extracorporeal shock wave therapy, consisting of a sequence of sonic (mechanical) impulses with high peak pressure.

Systematic reviews highlighted that shock waves effectively improve lower and upper limb spasticity. Moreover, the shock waves therapeutic effect can last up to 12 weeks from the last treatment session.

When used to treat stroke spasticity, the shock waves' mechanism of action is poorly detailed.

On the one side, shock waves could change the physical properties of the muscular tissue (e.g. viscosity, rigidity).

On the other, the shock waves produce a robust mechanical stimulation that massively activates muscle and skin mechanoreceptors (e.g. muscle spindles). This activation would modulate, in turn, the spinal (and supra-spinal) circuits involved in spasticity.

To our knowledge, no study investigated the shock waves mechanism of action in stroke upper limb spasticity.

Research question: do shock waves exert their therapeutic effect on spasticity by changing the muscle's physical properties or by indirectly modulating the excitability of spinal circuits?

Specific aims: To investigate the mechanism of action of shock wave therapy as a treatment of upper limb spasticity after a stroke.

Two major hypotheses will be contrasted: shock waves reduce hypertonia 1) by changing the muscle's physical features or 2) by changing the motoneurons excitability and the excitability of the stretch reflex spinal circuits.

Shock wave therapy is expected to improve spasticity, thus improving the following clinical tests: the Modified Ashworth Scale (an ordinal score of spasticity) and the Functional Assessment for Upper Limb (FAST-UL, an ordinal score of upper limb dexterity).

This clinical improvement is expected to be associated with changes in spastic muscle echotexture assessed with ultrasounds, such as an improvement in the Heckmatt scale (an ordinal score of muscle echotexture in spasticity).

Clinical improvement is also expected to be associated with an improvement in the following neurophysiological parameters: a reduction of the H/Mmax ratio (an index of hyperexcitability of the monosynaptic stretch reflex circuit), a decrease in amplitude of the F waves (a neurophysiological signal reflecting the excitability of single/restricted motoneurones) and an increase of the homosynaptic depression (also known as post-activation depression, reflecting the excitability of the transmission between the Ia fibres and motoneurones).

Understanding the shock wave mechanism of action will lead to a better clinical application of this spasticity treatment.

If the shock waves exert their therapeutic effect by changing the muscle's physical properties, they could be more appropriate for patients with muscle fibrosis on ultrasounds.

On the contrary, if the shock waves work on spasticity by indirectly acting on the nervous system's excitability, then a neurophysiology study could be used to preliminary identify the muscle groups with the most significant neurophysiological alterations, which could be the muscles benefitting the most from this treatment. conditions: Stroke conditions: Hemiparesis conditions: Hemiplegia conditions: Spasticity as Sequela of Stroke conditions: Upper Limb Hypertonia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 12 type: ESTIMATED name: Extracorporeal Shockwave Therapy measure: M wave and H reflex recruitment curve measure: H reflex post-activation depression measure: F waves measure: T reflex measure: Upper limb dexterity measures measure: Ultrasound arm and forearm assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Auxologico Italiano status: RECRUITING city: Milano state: MI zip: 20122 country: Italy name: Antonio Caronni, MD, PhD role: CONTACT phone: 02 619111 email: a.caronni@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06311513 id: 2023-1017 id: 1177535 type: OTHER_GRANT domain: Arthritis Foundation briefTitle: Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-12 date: 2028-12 date: 2024-03-15 date: 2024-03-15 name: Hospital for Special Surgery, New York class: OTHER name: Emory University name: Arthritis Foundation briefSummary: The goal of this pilot randomized clinical trial is to look into the efficacy of concentrated bone marrow aspirate (cBMA) in improving post traumatic osteoarthritis (PTOA) symptoms in patients undergoing revision anterior cruciate ligament reconstruction surgery. The main questions it aims to answer are whether clinical outcomes, such as pain, are improved in patients who get cBMA with surgery, if there is a change in circulating markers of inflammation and what part of the cellular and molecular composition of cBMA may explain its effects. conditions: Anterior Cruciate Ligament Injuries conditions: Post-Traumatic Osteoarthritis of Knee conditions: Bone Marrow Aspirate Concentrate conditions: ACL Injury studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a single-blinded randomized controlled trial. Participants will be allocated to either:

1. Investigational arm (Revision ACLR + cBMA)
2. Control arm (Revision ACLR + Sham Incision) primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Concentrated Bone Marrow Aspirate Injection name: Sham Incision name: Revision Anterior Cruciate Ligament Reconstruction measure: Change from baseline in patient reported knee pain measure: Expression of local inflammatory biomarkers measure: Concentration of circulating inflammatory biomarkers measure: Change from baseline in cartilage morphology measure: Change from baseline in articular cartilage relative proteoglycan content and collagen fibril organization sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Emory Orthopaedics & Spine Center city: Atlanta state: Georgia zip: 30097 country: United States lat: 33.749 lon: -84.38798 facility: Hospital for Special Surgery city: New York state: New York zip: 10021 country: United States name: Daniel de la Huerta, MD role: CONTACT phone: 212-606-1000 phoneExt: 2603159 email: delahuertamezad@hss.edu name: Miguel Otero, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06311500 id: STUDY00151143 briefTitle: Sleep Health Enhancement in Midlife Adults overallStatus: RECRUITING date: 2024-02-13 date: 2025-06-30 date: 2025-06-30 date: 2024-03-15 date: 2024-03-15 name: University of Kansas Medical Center class: OTHER briefSummary: Despite the strong links between sleep and AD, a sleep health enhancement has yet to be targeted in mid-life adults (45-64 years old) to delay or prevent AD. An intervention aimed at enhancing sleep health is a critical opportunity for primary prevention to potentially delay the onset of AD. The objective of the proposed study is to develop and assess the feasibility, acceptability, and treatment effect of a comprehensive sleep health intervention (SHI) on improving sleep health in mid-life adults conditions: Sleep Health conditions: Midlife Adults studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Sleep health enhancement intervention measure: 6-item Acceptability Scale measure: Qualitative interview measure: Ru-SATED Composite score measure: Sleep Self-Efficacy Scale measure: Pittsburgh Sleep Quality Index measure: Epworth Sleepiness Scale measure: Dysfunctional Beliefs About Sleep (DBAS-10) consists of 10 statements reflecting beliefs and attitudes about sleep. Each statement is rated from 1 = strongly disagree to 10 = strongly agree measure: Positive Affect and Negative Affect Schedule measure: Continuous Performance Test measure: Stroop Test measure: Cognitive Failures Questionnaire measure: Actigraphy sex: ALL minimumAge: 45 Years maximumAge: 64 Years stdAges: ADULT facility: University of Kansas Medical Center status: RECRUITING city: Kansas City state: Kansas zip: 66160 country: United States lat: 39.11417 lon: -94.62746 hasResults: False

 nctId: NCT06311487 id: 23-1388 id: 1R56DK136601-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R56DK136601-01 briefTitle: Time and Nutrient-Dependent Effects of Aerobic Exercise on Metabolism in Adults (TANDEM Study) acronym: TANDEM overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-08 date: 2025-08 date: 2024-03-15 date: 2024-03-29 name: University of Colorado, Denver class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: This study plans to learn more about metabolic responses to aerobic exercise at different times of the day (morning or evening) under fasting versus fed conditions. conditions: Overweight and Obesity conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: Fasted-AM name: Fed-AM name: Fasted-PM name: Fed-PM measure: Exercise Energy Expenditure (kcals) measure: Substrate Oxidation (Respiratory Quotient) sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Colorado Anschutz Medical Campus city: Aurora state: Colorado zip: 80045 country: United States name: Justin Lorentzen, BHS role: CONTACT phone: 303-724-3685 email: justin.lorentzen@cuanschutz.edu name: Shelby Panter, MS role: CONTACT phone: 303-724-3202 email: shelby.panter@cuanschutz.edu name: Seth Creasy, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 hasResults: False

 nctId: NCT06311474 id: W81XWH-22-1-0250 briefTitle: Remote Assessment and Intervention for Behavior Problems in Kids With TSC acronym: RAINBOW overallStatus: RECRUITING date: 2022-08-01 date: 2025-04-30 date: 2025-07-31 date: 2024-03-15 date: 2024-03-15 name: University of California, Los Angeles class: OTHER briefSummary: The RAINBOW study is a fully remote study focused on understanding and treating behavior problems in young children with tuberous sclerosis complex (TSC). The first goal is to enroll a group of 100 children with TSC between the ages of 3 and 6 years old, with and without problem behaviors, to learn about how best to measure behavioral challenges in TSC and how common these behaviors are during this age period. All families will get feedback from the clinical assessments collected. Eligible children who are experiencing behavior problems will be invited to enroll in a pilot clinical trial of internet-based Parent-Child Interaction Therapy (or PCIT), which is meant to help parents better manage their children's challenging behaviors. Adaptations to PCIT are incorporated to suit the needs of TSC children and families. Some participants will be randomly selected to receive the intervention immediately and others after a 6-month delay, but all families will receive the same intervention. Intervention sessions occur on a weekly basis for up to 20 weeks. Follow-up assessments, which include play interactions, parent interviews, and questionnaires occur about 3 and 6 months after the first visit. The delayed treatment group has an extra brief assessment about 12 months from the initial visit. This study will increase what is known about the types of behavior problems that come up during preschool age in TSC and how best to help children and families with TSC who are experiencing these problems. conditions: Tuberous Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The clinical trial portion of this study uses a waitlist control design with random assignment to group. Randomization is stratified by age (3-4 years old, 5-6 years old). primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcome assessments will be performed by assessors who are blind to group status. Investigators will be kept blind to study outcomes until data collection for the primary outcome is complete. whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Parent-Child Interaction Therapy (PCIT) measure: Eyberg Child Behavior Inventory (ECBI) measure: Behavior Assessment Scale for Children-3rd Edition (BASC-3) measure: Vineland Adaptive Behavior Scales-3rd Edition (Vineland-3) measure: Parenting Stress Index-4th Edition-Short Form (PSI-4-SF) measure: Dyadic Parent-Child Interaction Coding System (DPICS) measure: Therapy Attitude Index (TAI) measure: Telehealth Usability Questionnaire (TUQ) measure: Aberrant Behavior Checklist (ABC) sex: ALL minimumAge: 3 Years maximumAge: 6 Years stdAges: CHILD facility: University of California, Los Angeles status: RECRUITING city: Los Angeles state: California zip: 90095 country: United States name: Viviana Rodriguez role: CONTACT phone: 424-326-3118 email: vivianarodriguez@mednet.ucla.edu name: Nicole McDonald role: CONTACT phone: 310-825-3251 email: nmcdonald@mednet.ucla.edu name: Nicole McDonald, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06311461 id: 22-001111 briefTitle: Effects of Acupuncture on Symptoms of Stable Angina acronym: EASE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2027-06-30 date: 2024-03-15 date: 2024-03-15 name: University of California, Los Angeles class: OTHER name: University of Illinois at Chicago briefSummary: The goal of this clinical trial is to determine if a standardized 12-point acupuncture protocol will reduce pain in participants with stable angina.

This study addresses the critical need to reduce persistent pain for angina. The investigators long-term goal is symptom management for diverse women and men with angina, targeting additional angina burden borne of social disadvantage

Participants will be randomized to a 10-acupuncture session protocol, two treatments per week for five weeks, or an attention control group. Participants will view designated, non-pain related Technology, Entertainment, Design Talks equal to the time spent receiving acupuncture (\~7.5-10 hrs.).

The investigators will test the efficacy of acupuncture for stable angina/chest pain syndrome to reduce pain and symptoms, improve health-related quality of life, reduce healthcare utilization and and improve patient related health outcomes. conditions: Angina, Stable studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 112 type: ESTIMATED name: Acupuncture name: Attention control measure: Pain Now measure: Worst Pain measure: Least Pain measure: Acute Coronary Syndrome like symptoms (ACS Symptom Checklist) measure: Anginal Pain (Seattle Angina Questionnaire-7) measure: Number of Angina Attacks (From American Heart Association Angina Log) measure: Symptom Triggers (From American Heart Association Angina Log) measure: Pain from Angina Attack (From American Heart Association Angina Log) measure: Length of Angina Attack (American Heart Association Angina Log) measure: Self-treatment for Symptoms (From American Heart Association Angina Log) measure: Functional Status Related to Angina (Seattle Angina Questionnaire-7) measure: General Functional Status (PROMIS 29v.2) measure: Quality of Life (Seattle Angina Questionnaire-7) measure: Use of Nitrates and Analgesics (AHA Angina log) measure: Patient Reported Outcomes (Patient Reported Outcomes Measurement Information System-29v.2 measure: Healthcare Utilization measure: Ischemia on Electrocardiogram (ECG) sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06311448 id: 10094 briefTitle: Personalized Targeted Immunomodulation in COVID-19 ARDS acronym: COMODULATE overallStatus: COMPLETED date: 2020-03-02 date: 2022-02-01 date: 2022-02-01 date: 2024-03-15 date: 2024-03-15 name: Erasmus Medical Center class: OTHER name: Amsterdam UMC name: Leiden University Medical Center name: St. Antonius Hospital briefSummary: Rationale: In COVID19 single-targeted immunomodulation, mostly via an IL-6 receptor blocker, was used by a one-size fits all non-targeted approach. In future pandemics the same might occur. However, for individual patients, this might not yield optimal treatment.

Objectives: This project aims to identify a way to individualize and target immunomodulation, using COVID19 as a testcase for the future.

* Identify immunological pathways which are associated with outcome in C-ARDS.
* Test whether an individualized biomarker-based approach has an effect on outcome and costs when using single-target immunomodulation in C-ARDS(Tocilizumab, Anakinra, etc.).
* Explore whether other immunological pathways were present in patients with C-ARDS which could have been intervened with medication which is already available and has been described in ARDS or similar diseases.

Study type: Retrospective observational multicenter study in the Netherlands.

Study population: Adult patients (≥ 18 years) hospitalized and admitted to the ICU with COVID-19 and acute respiratory distress syndrome (ARDS) (i.e., receiving invasive mechanical ventilation) will be included.

Intervention (if applicable): Not applicable (retrospective study design).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Given the retrospective nature of the study, no burden, risks or benefits for the patient are associated with participation. The target population of this study is specific to hospitalized patients with COVID-19. conditions: COVID-19 Acute Respiratory Distress Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 164 type: ACTUAL name: Single target immunomodulation name: Standard of care measure: Mortality up to day 90 measure: Change in SOFA score measure: Ventilator free days measure: Change in biomarker values measure: Costs of immmunomodulation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus Medical Centre city: Rotterdam state: Zuid-Holland zip: 3015 GD country: Netherlands lat: 51.9225 lon: 4.47917 hasResults: False

 nctId: NCT06311435 id: FBB-RNA-004 briefTitle: Utilizing Novel Blood RNA Biomarkers as a Diagnostic Tool in the Identification of Long COVID-19 overallStatus: RECRUITING date: 2024-03-15 date: 2026-03-15 date: 2026-03-15 date: 2024-03-15 date: 2024-03-15 name: MaxWell Clinic, PLC class: INDUSTRY briefSummary: The primary objective of this study is to determine, in unblinded samples, whether artificial intelligence can classify specific blood RNA from patients with long COVID together and separately from apparently healthy normals and other medical conditions which share signs and symptoms of long COVID. conditions: Long COVID studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be placed into one of eleven possible cohorts based on their presenting complaints. primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: Patients will be assigned a random number from the electronic health record. The only information shared with the sponsor will be Pt ID number, age, gender and state of residence. whoMasked: PARTICIPANT count: 3000 type: ESTIMATED name: RNA Biomarker Blood Test measure: Artificial Intelligence Identified number of RNA Biomarkers for Long COVID measure: Artificial Intelligence Identified number of RNA Biomarkers for specific Long COVID subgroups sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The MaxWell Clinic status: RECRUITING city: Brentwood state: Tennessee zip: 37027 country: United States name: Justin Davis role: CONTACT phone: 615-370-0091 email: Justin@maxwellclinic.com name: Cale T Queen, PhD role: CONTACT phone: 16153700091 email: cale@maxwellclinic.com name: David H Haase, MD role: PRINCIPAL_INVESTIGATOR lat: 36.03312 lon: -86.78278 facility: The MaxWell Clinic status: RECRUITING city: Brentwood state: Tennessee zip: 37027 country: United States name: Justin Davis role: CONTACT phone: 615-370-0091 email: justin@maxwellclinic.com name: Cale T Queen, PhD. role: CONTACT phone: 6153700091 email: cale@maxwellclinic.com name: David H Haase, MD role: PRINCIPAL_INVESTIGATOR lat: 36.03312 lon: -86.78278 hasResults: False

 nctId: NCT06311422 id: CAD/CAM-endocrown briefTitle: A 3-Year Clinical Evaluation Of Endocrown Restorations With Two Different Materials overallStatus: ACTIVE_NOT_RECRUITING date: 2020-03-15 date: 2023-03-15 date: 2028-09-15 date: 2024-03-15 date: 2024-03-19 name: Hacettepe University class: OTHER briefSummary: The clinical performance of two different materials in endodontically treated teeth produced with CAD/CAM system will be evaluated and compared. After obtaining a signed informed consert form from all the patients, all restorations will be placed by a single clinician. All endocrown restorations will be produced using the same CAD/CAM system. 52 restorations will be fabricated using Lava Ultimate (LU, 3M Espe, Seefeld, Germany) blocks and 38 restorations will be fabricated using Celtra Duo (CD, Dentsply Sirona, York, PA, USA) blocks. All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after baseline, 6,12,36, 48, 60 months. Descriptive statistics will be performed using Chi-square and Fisher exact test. conditions: Endodontically Treated Teeth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 74 type: ACTUAL name: resin nanoceramic block name: zirconia-reinforced lithium silicate measure: Clinical performance of two materials sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hacettepe University Faculty of Dentistry city: Ankara zip: 06060 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06311409 id: SMFS2019 briefTitle: Validation Study of the Speedy Meyer Fall Scale for Determining the Fall Risk of the Paediatric Patient overallStatus: RECRUITING date: 2020-01-29 date: 2024-03 date: 2024-04 date: 2024-03-15 date: 2024-03-15 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Fall prevention is an essential element in ensuring safe care for paediatric patients. The first step in building a risk reduction programme is the adoption of an assessment tool to identify those most at risk at an early stage. From October 2014 to date, a study has been conducted for the linguistic-cultural validation of the Humpty Dumpty Fall Scale (HDFS) in the Italian context, through a multicentre survey with the help of the Clinical Risk Management Group of the Region of Tuscany.

The objective of this study is the validation of the new Humpty Dumpty Fall Scale defined as Speedy Meyer-Fall Scale (SMFS) by assessing the comprehension and validity of the scale and items via Content Validity Index (SCVI and ICVI) estimation of inter-item reliability (Crombach's alpha), inter-rater reliability (Cohen's K), sensitivity, specificity, PPV, NPV and ROC curve. conditions: Fall Prevention studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 332 type: ESTIMATED measure: validation of the SMFS t measure: identification of patients high risk of falls sex: ALL minimumAge: 1 Year maximumAge: 16 Years stdAges: CHILD facility: AUSL Toscana Sud Est status: NOT_YET_RECRUITING city: Arezzo zip: 51100 country: Italy lat: 43.46276 lon: 11.88068 facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence country: Italy name: Daniele Ciofi role: CONTACT email: daniele.ciofi@meyer.it lat: 43.77925 lon: 11.24626 facility: Fondazione Gabriele monasterio - Ospedale Pediatrico Apuano Massa status: NOT_YET_RECRUITING city: Massa country: Italy lat: 44.03541 lon: 10.13927 hasResults: False

 nctId: NCT06311396 id: REVEAL briefTitle: Development of a Neuronal Microscope overallStatus: RECRUITING date: 2021-01-01 date: 2024-01-01 date: 2025-01-01 date: 2024-03-15 date: 2024-03-15 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and is a leading cause of cancer-related death worldwide. The prognosis of HCC remains poor, with a 5-year survival rate of 18%. Risk factors for HCC include viral infection, autoimmune hepatitis, chronic alcohol use or metabolic fatty liver disease, obesity, and diabetes mellitus. conditions: Hepatic Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 30 type: ESTIMATED name: genetic model measure: Isolation of epithelial cells measure: Omics studies and functional morphological studies sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica status: RECRUITING city: Milan state: Milano zip: 20122 country: Italy name: Luca Vittorio Carlo Valenti role: CONTACT phone: 02 5503 6595 phoneExt: 56595 email: luca.valenti@policlinico.mi.it lat: 45.46427 lon: 9.18951 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2020-12-09 uploadDate: 2024-03-08T10:03 filename: Prot_SAP_000.pdf size: 2182994 hasResults: False

 nctId: NCT06311383 id: CLEE011ADE03 briefTitle: A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Ribociclib + AI/FUL, or With Endocrine Therapy or Chemotherapy as First Line Treatment acronym: RIBANNA overallStatus: ACTIVE_NOT_RECRUITING date: 2017-10-09 date: 2025-02-16 date: 2025-02-16 date: 2024-03-15 date: 2024-04-05 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: This is a non-interventional observational study conducted in Germany to evaluate the real-world effectiveness, tolerability, safety, and quality of life in patients with locally advanced/metastatic HR+/HER2- breast cancer treated with one of the following 1st line treatments: Ribociclib + AI/FUL, or endocrine monotherapy, or chemotherapy conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2610 type: ACTUAL name: First-line Ribociclib + endocrine therapy name: First-line endocrine therapy name: First-line chemtherapy measure: Progression-free survival (PFS) measure: Cox proportional hazard regression for progression free survival in 1st line therapy measure: Propensity Score matching for progression free survival in 1st line therapy measure: Sequential progression-free survival (PFS_S) measure: Conditional progression-free survival measure: Time to treatment failure (TTF) measure: Time to first chemotherapy measure: Time to next treatment / therapy (TTNT) after 1st line treatment measure: Overall survival (OS) measure: Dose reduction measure: Dose interruption measure: Discontinuations measure: Adherence - MMAS-8 questionnaire measure: Number of participants with mutations measure: Quality of life for specific cohorts and treatment lines - EORTC QLQ-C30 measure: Quality of life for specific cohorts and treatment lines - EORTC QLQ-B23 measure: Quality of life for specific cohorts and treatment lines - HADS-D sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Novartis Investigative Site city: Freudenstadt state: Baden Wuerttemberg zip: 72250 country: Germany lat: 48.46695 lon: 8.41371 facility: Novartis Investigative Site city: Karlsruhe state: Baden Wuerttemberg zip: 76199 country: Germany lat: 49.00937 lon: 8.40444 facility: Novartis Investigative Site city: Mannheim state: Baden Wuerttemberg zip: 68165 country: Germany lat: 49.4891 lon: 8.46694 facility: Novartis Investigative Site city: Nuertingen state: Baden Wuerttemberg zip: 72622 country: Germany facility: Novartis Investigative Site city: Reutlingen state: Baden Wuerttemberg zip: 72764 country: Germany lat: 48.49144 lon: 9.20427 facility: Novartis Investigative Site city: Winnenden state: Baden Wuerttemberg zip: 71364 country: Germany lat: 48.87563 lon: 9.39819 facility: Novartis Investigative Site city: Ostfildern state: Baden Württemberg zip: 73760 country: Germany lat: 48.72704 lon: 9.24954 facility: Novartis Investigative Site city: Baden-Baden state: Baden-Wuerttemberg zip: 76532 country: Germany lat: 48.7606 lon: 8.23975 facility: Novartis Investigative Site city: Mutlangen state: Baden-Wuerttemberg zip: 73557 country: Germany lat: 48.82588 lon: 9.79714 facility: Novartis Investigative Site city: Rottweil state: Baden-Wuerttemberg zip: 78628 country: Germany lat: 48.16783 lon: 8.62719 facility: Novartis Investigative Site city: Schwaebisch state: Baden-Wuerttemberg zip: 74523 country: Germany facility: Novartis Investigative Site city: Sigmaringen state: Baden-Wuerttemberg zip: 72488 country: Germany lat: 48.08829 lon: 9.23033 facility: Novartis Investigative Site city: Augsburg state: Bavaria zip: 86152 country: Germany lat: 48.37154 lon: 10.89851 facility: Novartis Investigative Site city: Bamberg state: Bavaria zip: 96052 country: Germany lat: 49.89873 lon: 10.90067 facility: Novartis Investigative Site city: Muenchen state: Bavaria zip: 80639 country: Germany lat: 51.60698 lon: 13.31243 facility: Novartis Investigative Site city: Altoetting state: Bayern zip: 84503 country: Germany facility: Novartis Investigative Site city: Amberg state: Bayern zip: 92224 country: Germany lat: 49.44287 lon: 11.86267 facility: Novartis Investigative Site city: Ansbach state: Bayern zip: 91522 country: Germany lat: 49.30481 lon: 10.5931 facility: Novartis Investigative Site city: Aschaffenburg state: Bayern zip: 63739 country: Germany lat: 49.97704 lon: 9.15214 facility: Novartis Investigative Site city: Bayreuth state: Bayern zip: 95445 country: Germany lat: 49.94782 lon: 11.57893 facility: Novartis Investigative Site city: Ebersberg state: Bayern zip: 85560 country: Germany lat: 48.0771 lon: 11.97063 facility: Novartis Investigative Site city: Landshut state: Bayern zip: 84036 country: Germany lat: 48.52961 lon: 12.16179 facility: Novartis Investigative Site city: Muenchen state: Bayern zip: 81241 country: Germany lat: 51.60698 lon: 13.31243 facility: Novartis Investigative Site city: Muenchen state: Bayern zip: 81925 country: Germany lat: 51.60698 lon: 13.31243 facility: Novartis Investigative Site city: Nuernberg state: Bayern zip: 90409 country: Germany lat: 49.45421 lon: 11.07752 facility: Novartis Investigative Site city: Regensburg state: Bayern zip: 93053 country: Germany lat: 49.01513 lon: 12.10161 facility: Novartis Investigative Site city: Rosenheim state: Bayern zip: 83022 country: Germany lat: 47.85637 lon: 12.12247 facility: Novartis Investigative Site city: Straubing state: Bayern zip: 94315 country: Germany lat: 48.88126 lon: 12.57385 facility: Novartis Investigative Site city: Wuerzburg state: Bayern zip: 97070 country: Germany lat: 49.79391 lon: 9.95121 facility: Novartis Investigative Site city: Mannheim state: Beden Wuerttenberg zip: 68167 country: Germany lat: 49.4891 lon: 8.46694 facility: Novartis Investigative Site city: Brandenburg A D Havel state: Brandenburg zip: 14770 country: Germany facility: Novartis Investigative Site city: Doberlug Kirchhain state: Brandenburg zip: 03253 country: Germany lat: 51.62578 lon: 13.56232 facility: Novartis Investigative Site city: Fuerstenwalde state: Brandenburg zip: 15517 country: Germany facility: Novartis Investigative Site city: Ludwigsfelde state: Brandenburg zip: 14974 country: Germany lat: 52.30322 lon: 13.25405 facility: Novartis Investigative Site city: Neu-Brandenburg state: Brandenburg zip: 17036 country: Germany facility: Novartis Investigative Site city: Spremberg state: Brandenburg zip: 03130 country: Germany lat: 51.56971 lon: 14.37355 facility: Novartis Investigative Site city: Bremerhaven state: Bremen zip: 27576 country: Germany lat: 53.55021 lon: 8.57673 facility: Novartis Investigative Site city: Bayern state: Donauworth zip: 86609 country: Germany lat: 47.795 lon: 12.53381 facility: Novartis Investigative Site city: Baden-Württemberg state: Heidenheim a.d.B zip: 89522 country: Germany facility: Novartis Investigative Site city: Bad Homburg state: Hessen zip: 61352 country: Germany lat: 50.22683 lon: 8.61816 facility: Novartis Investigative Site city: Bad Nauheim state: Hessen zip: 61231 country: Germany lat: 50.36463 lon: 8.73859 facility: Novartis Investigative Site city: Darmstadt state: Hessen zip: 64283 country: Germany lat: 49.87167 lon: 8.65027 facility: Novartis Investigative Site city: Erbach state: Hessen zip: 64711 country: Germany lat: 49.66148 lon: 8.99402 facility: Novartis Investigative Site city: Langen state: Hessen zip: 63225 country: Germany lat: 49.98955 lon: 8.66852 facility: Novartis Investigative Site city: Lich state: Hessen zip: 35423 country: Germany lat: 50.52085 lon: 8.81567 facility: Novartis Investigative Site city: Marburg state: Hessen zip: 35043 country: Germany lat: 50.80904 lon: 8.77069 facility: Novartis Investigative Site city: Arnsberg Huesten state: Hochsauerland zip: 59759 country: Germany facility: Novartis Investigative Site city: Twistringen state: Lower Saxony zip: 27239 country: Germany lat: 52.79926 lon: 8.64163 facility: Novartis Investigative Site city: Rostock state: Mecklenburg Vorpommern zip: 18057 country: Germany lat: 54.0887 lon: 12.14049 facility: Novartis Investigative Site city: Schwerin state: Mecklenburg Vorpommern zip: 19059 country: Germany lat: 53.62937 lon: 11.41316 facility: Novartis Investigative Site city: Stralsund state: Mecklenburg Vorpommern zip: 18435 country: Germany lat: 54.30911 lon: 13.0818 facility: Novartis Investigative Site city: Braunschweig state: Niedersachsen zip: 38100 country: Germany lat: 52.26594 lon: 10.52673 facility: Novartis Investigative Site city: Buchholz state: Niedersachsen zip: 21244 country: Germany lat: 53.00884 lon: 9.56287 facility: Novartis Investigative Site city: Damme state: Niedersachsen zip: 49401 country: Germany lat: 52.52157 lon: 8.19793 facility: Novartis Investigative Site city: Georgsmarienhuette state: Niedersachsen zip: 49124 country: Germany facility: Novartis Investigative Site city: Hameln state: Niedersachsen zip: 31785 country: Germany lat: 52.10397 lon: 9.35623 facility: Novartis Investigative Site city: Hannover state: Niedersachsen zip: 30171 country: Germany lat: 52.37052 lon: 9.73322 facility: Novartis Investigative Site city: Lingen state: Niedersachsen zip: 49808 country: Germany lat: 52.52143 lon: 7.31845 facility: Novartis Investigative Site city: Osnabrueck state: Niedersachsen zip: 49076 country: Germany facility: Novartis Investigative Site city: Quedlinburg state: Niedersachsen zip: 06484 country: Germany lat: 51.78843 lon: 11.15006 facility: Novartis Investigative Site city: Westerstede state: Niedersachsen zip: 26655 country: Germany lat: 53.25682 lon: 7.92737 facility: Novartis Investigative Site city: Wolfenbuettel state: Niedersachsen zip: 38304 country: Germany facility: Novartis Investigative Site city: Bergisch Gladbach state: Nordrhein Westfalen zip: 51465 country: Germany lat: 50.9856 lon: 7.13298 facility: Novartis Investigative Site city: Bielefeld state: Nordrhein Westfalen zip: 33611 country: Germany lat: 52.03333 lon: 8.53333 facility: Novartis Investigative Site city: Bielefeld state: Nordrhein Westfalen zip: 33615 country: Germany lat: 52.03333 lon: 8.53333 facility: Novartis Investigative Site city: Bonn state: Nordrhein Westfalen zip: 53113 country: Germany lat: 50.73438 lon: 7.09549 facility: Novartis Investigative Site city: Bonn state: Nordrhein Westfalen zip: 53177 country: Germany lat: 50.73438 lon: 7.09549 facility: Novartis Investigative Site city: Dortmund state: Nordrhein Westfalen zip: 44137 country: Germany lat: 51.51494 lon: 7.466 facility: Novartis Investigative Site city: Duesseldorf state: Nordrhein Westfalen zip: 40325 country: Germany lat: 51.22172 lon: 6.77616 facility: Novartis Investigative Site city: Duesseldorf state: Nordrhein Westfalen zip: 40625 country: Germany lat: 51.22172 lon: 6.77616 facility: Novartis Investigative Site city: Gelsenkirchen state: Nordrhein Westfalen zip: 45879 country: Germany lat: 51.50508 lon: 7.09655 facility: Novartis Investigative Site city: Herdecke state: Nordrhein Westfalen zip: 58313 country: Germany lat: 51.39999 lon: 7.43584 facility: Novartis Investigative Site city: Hilden state: Nordrhein Westfalen zip: 40724 country: Germany lat: 51.16818 lon: 6.93093 facility: Novartis Investigative Site city: Krefeld state: Nordrhein Westfalen zip: 47805 country: Germany lat: 51.33645 lon: 6.55382 facility: Novartis Investigative Site city: Lemgo state: Nordrhein Westfalen zip: 32657 country: Germany lat: 52.02786 lon: 8.89901 facility: Novartis Investigative Site city: Neuss state: Nordrhein Westfalen zip: 41464 country: Germany lat: 51.19807 lon: 6.68504 facility: Novartis Investigative Site city: Olpe state: Nordrhein Westfalen zip: 57462 country: Germany lat: 51.02899 lon: 7.85139 facility: Novartis Investigative Site city: Paderborn state: Nordrhein Westfalen zip: 33098 country: Germany lat: 51.71905 lon: 8.75439 facility: Novartis Investigative Site city: Siegen state: Nordrhein Westfalen zip: 57072 country: Germany lat: 50.87481 lon: 8.02431 facility: Novartis Investigative Site city: Wesel state: Nordrhein Westfalen zip: 46483 country: Germany lat: 51.6669 lon: 6.62037 facility: Novartis Investigative Site city: Wesel state: Nordrhein Westfalen zip: 46485 country: Germany lat: 51.6669 lon: 6.62037 facility: Novartis Investigative Site city: Witten state: Nordrhein Westfalen zip: 58455 country: Germany lat: 51.44362 lon: 7.35258 facility: Novartis Investigative Site city: Koeln state: Nordrhein Westphalen zip: 50179 country: Germany lat: 50.93333 lon: 6.95 facility: Novartis Investigative Site city: Bochum state: Nordrhein-Westfalen zip: 44787 country: Germany lat: 51.48165 lon: 7.21648 facility: Novartis Investigative Site city: Dortmund state: Nordrhein-Westfalen zip: 44309 country: Germany lat: 51.51494 lon: 7.466 facility: Novartis Investigative Site city: Herne state: Nordrhein-Westfalen zip: 44649 country: Germany lat: 51.5388 lon: 7.22572 facility: Novartis Investigative Site city: Remscheid state: Nordrhein-Westfalen zip: 42853 country: Germany lat: 51.17983 lon: 7.1925 facility: Novartis Investigative Site city: Troisdorf state: Nordrhein-Westfalen zip: 53840 country: Germany lat: 50.80901 lon: 7.14968 facility: Novartis Investigative Site city: Velbert state: North Rhine-Westphalia zip: 42551 country: Germany lat: 51.33537 lon: 7.04348 facility: Novartis Investigative Site city: Hagen state: Northrhine Westfalia zip: 58095 country: Germany lat: 51.36081 lon: 7.47168 facility: Novartis Investigative Site city: Remscheid Innen state: Northrhine Westfalia zip: 42859 country: Germany facility: Novartis Investigative Site city: Eggenfelde state: Passau zip: 84307 country: Germany facility: Novartis Investigative Site city: Mayen state: Rheinland Pfalz zip: 56727 country: Germany lat: 50.32797 lon: 7.22277 facility: Novartis Investigative Site city: Simmern state: Rheinland Pfalz zip: 55469 country: Germany lat: 49.98198 lon: 7.52351 facility: Novartis Investigative Site city: Neustadt state: Rheinland-Pfalz zip: 67434 country: Germany lat: 49.35009 lon: 8.13886 facility: Novartis Investigative Site city: Magdeburg state: Sachsen Anhalt zip: 39108 country: Germany lat: 52.12773 lon: 11.62916 facility: Novartis Investigative Site city: Magdeburg state: Sachsen Anhalt zip: 39130 country: Germany lat: 52.12773 lon: 11.62916 facility: Novartis Investigative Site city: Dresden state: Sachsen zip: 01127 country: Germany lat: 51.05089 lon: 13.73832 facility: Novartis Investigative Site city: Dresden state: Sachsen zip: 01307 country: Germany lat: 51.05089 lon: 13.73832 facility: Novartis Investigative Site city: Leipzig state: Sachsen zip: 04103 country: Germany lat: 51.33962 lon: 12.37129 facility: Novartis Investigative Site city: Pirna state: Sachsen zip: 01796 country: Germany lat: 50.95843 lon: 13.93702 facility: Novartis Investigative Site city: Rodewisch state: Sachsen zip: 08228 country: Germany lat: 50.53083 lon: 12.41329 facility: Novartis Investigative Site city: Scheibenberg state: Sachsen zip: 09481 country: Germany lat: 50.54023 lon: 12.91215 facility: Novartis Investigative Site city: Schkeuditz state: Sachsen zip: 04435 country: Germany lat: 51.39678 lon: 12.22141 facility: Novartis Investigative Site city: Zittau state: Sachsen zip: 02763 country: Germany lat: 50.89772 lon: 14.80764 facility: Novartis Investigative Site city: Zxickau state: Sachsen zip: 08060 country: Germany facility: Novartis Investigative Site city: Flensburg state: Schleswig Flensburg zip: 24939 country: Germany lat: 54.78431 lon: 9.43961 facility: Novartis Investigative Site city: Luebeck state: Schleswig-Holstein zip: 23563 country: Germany lat: 53.86893 lon: 10.68729 facility: Novartis Investigative Site city: Apolda state: Thueringen zip: 99510 country: Germany lat: 51.02624 lon: 11.51638 facility: Novartis Investigative Site city: Eisenach state: Thueringen zip: 99817 country: Germany lat: 50.9807 lon: 10.31522 facility: Novartis Investigative Site city: Erfurt state: Thueringen zip: 99084 country: Germany lat: 50.9787 lon: 11.03283 facility: Novartis Investigative Site city: Meinigen state: Thueringen zip: 98617 country: Germany facility: Novartis Investigative Site city: Suhl state: Thueringen zip: 98527 country: Germany lat: 50.60911 lon: 10.69401 facility: Novartis Investigative Site city: Altoetting zip: 84503 country: Germany facility: Novartis Investigative Site city: Augsburg zip: 86150 country: Germany lat: 48.37154 lon: 10.89851 facility: Novartis Investigative Site city: Augsburg zip: 86179 country: Germany lat: 48.37154 lon: 10.89851 facility: Novartis Investigative Site city: Bad Liebenwerda zip: 04924 country: Germany lat: 51.51826 lon: 13.39459 facility: Novartis Investigative Site city: Bamberg zip: 96049 country: Germany lat: 49.89873 lon: 10.90067 facility: Novartis Investigative Site city: Bayreuth zip: 95445 country: Germany lat: 49.94782 lon: 11.57893 facility: Novartis Investigative Site city: Berlin zip: 10117 country: Germany lat: 52.52437 lon: 13.41053 facility: Novartis Investigative Site city: Berlin zip: 10317 country: Germany lat: 52.52437 lon: 13.41053 facility: Novartis Investigative Site city: Berlin zip: 10715 country: Germany lat: 52.52437 lon: 13.41053 facility: Novartis Investigative Site city: Berlin zip: 12487 country: Germany lat: 52.52437 lon: 13.41053 facility: Novartis Investigative Site city: Berlin zip: 13187 country: Germany lat: 52.52437 lon: 13.41053 facility: Novartis Investigative Site city: Berlin zip: 13353 country: Germany lat: 52.52437 lon: 13.41053 facility: Novartis Investigative Site city: Berlin zip: 13581 country: Germany lat: 52.52437 lon: 13.41053 facility: Novartis Investigative Site city: Berlin zip: 14169 country: Germany lat: 52.52437 lon: 13.41053 facility: Novartis Investigative Site city: Berlin zip: 14197 country: Germany lat: 52.52437 lon: 13.41053 facility: Novartis Investigative Site city: Bochum zip: 44791 country: Germany lat: 51.48165 lon: 7.21648 facility: Novartis Investigative Site city: Boeblingen zip: 71032 country: Germany facility: Novartis Investigative Site city: Bonn zip: 53111 country: Germany lat: 50.73438 lon: 7.09549 facility: Novartis Investigative Site city: Bonn zip: 53113 country: Germany lat: 50.73438 lon: 7.09549 facility: Novartis Investigative Site city: Bottrop zip: 46236 country: Germany lat: 51.52392 lon: 6.9285 facility: Novartis Investigative Site city: Brandenburg zip: 14770 country: Germany lat: 52.41667 lon: 12.55 facility: Novartis Investigative Site city: Bremen zip: 28205 country: Germany lat: 53.07516 lon: 8.80777 facility: Novartis Investigative Site city: Bremen zip: 28209 country: Germany lat: 53.07516 lon: 8.80777 facility: Novartis Investigative Site city: Bremen zip: 28239 country: Germany lat: 53.07516 lon: 8.80777 facility: Novartis Investigative Site city: Bremerhaven zip: 27574 country: Germany lat: 53.55021 lon: 8.57673 facility: Novartis Investigative Site city: Celle zip: 29223 country: Germany lat: 52.62264 lon: 10.08047 facility: Novartis Investigative Site city: Chemnitz zip: 09113 country: Germany lat: 50.8357 lon: 12.92922 facility: Novartis Investigative Site city: Chemnitz zip: 09117 country: Germany lat: 50.8357 lon: 12.92922 facility: Novartis Investigative Site city: Cottbus zip: 03048 country: Germany lat: 51.75769 lon: 14.32888 facility: Novartis Investigative Site city: Dessau Rosslau zip: 06847 country: Germany facility: Novartis Investigative Site city: Dresden zip: 01307 country: Germany lat: 51.05089 lon: 13.73832 facility: Novartis Investigative Site city: Erfurt zip: 99084 country: Germany lat: 50.9787 lon: 11.03283 facility: Novartis Investigative Site city: Erlangen zip: 91054 country: Germany lat: 49.59099 lon: 11.00783 facility: Novartis Investigative Site city: Essen zip: 45147 country: Germany lat: 51.45657 lon: 7.01228 facility: Novartis Investigative Site city: Esslingen zip: 73730 country: Germany lat: 48.73961 lon: 9.30473 facility: Novartis Investigative Site city: Eutin zip: 23701 country: Germany lat: 54.14054 lon: 10.60751 facility: Novartis Investigative Site city: Frankfurt zip: 60398 country: Germany lat: 50.11552 lon: 8.68417 facility: Novartis Investigative Site city: Frankfurt zip: 60431 country: Germany lat: 50.11552 lon: 8.68417 facility: Novartis Investigative Site city: Frankfurt zip: 65929 country: Germany lat: 50.11552 lon: 8.68417 facility: Novartis Investigative Site city: Freiburg zip: 79106 country: Germany lat: 47.9959 lon: 7.85222 facility: Novartis Investigative Site city: Friedberg zip: 86316 country: Germany lat: 48.35693 lon: 10.98461 facility: Novartis Investigative Site city: Friedrichshafen zip: 88045 country: Germany lat: 47.65689 lon: 9.47554 facility: Novartis Investigative Site city: Gera zip: 07548 country: Germany lat: 50.88029 lon: 12.08187 facility: Novartis Investigative Site city: Goch zip: 47574 country: Germany lat: 51.67873 lon: 6.15895 facility: Novartis Investigative Site city: Goettingen zip: 37073 country: Germany facility: Novartis Investigative Site city: Goettingen zip: 37075 country: Germany facility: Novartis Investigative Site city: Goslar zip: 38642 country: Germany lat: 51.90425 lon: 10.42766 facility: Novartis Investigative Site city: Greifswald zip: 17475 country: Germany lat: 54.09311 lon: 13.38786 facility: Novartis Investigative Site city: Gummersbach zip: 51643 country: Germany lat: 51.02608 lon: 7.56473 facility: Novartis Investigative Site city: Halberstadt zip: 38820 country: Germany lat: 51.89562 lon: 11.05622 facility: Novartis Investigative Site city: Halle zip: 06110 country: Germany lat: 51.48159 lon: 11.97948 facility: Novartis Investigative Site city: Hamburg zip: 20259 country: Germany lat: 53.57532 lon: 10.01534 facility: Novartis Investigative Site city: Hamburg zip: 20357 country: Germany lat: 53.57532 lon: 10.01534 facility: Novartis Investigative Site city: Hamburg zip: 22081 country: Germany lat: 53.57532 lon: 10.01534 facility: Novartis Investigative Site city: Hamburg zip: 22087 country: Germany lat: 53.57532 lon: 10.01534 facility: Novartis Investigative Site city: Hamburg zip: 22291 country: Germany lat: 53.57532 lon: 10.01534 facility: Novartis Investigative Site city: Hamburg zip: 22457 country: Germany lat: 53.57532 lon: 10.01534 facility: Novartis Investigative Site city: Hameln zip: 31785 country: Germany lat: 52.10397 lon: 9.35623 facility: Novartis Investigative Site city: Hanau zip: 63450 country: Germany lat: 50.13423 lon: 8.91418 facility: Novartis Investigative Site city: Hannover zip: 30161 country: Germany lat: 52.37052 lon: 9.73322 facility: Novartis Investigative Site city: Hannover zip: 30177 country: Germany lat: 52.37052 lon: 9.73322 facility: Novartis Investigative Site city: Hannover zip: 30625 country: Germany lat: 52.37052 lon: 9.73322 facility: Novartis Investigative Site city: Hildesheim zip: 31134 country: Germany lat: 52.15077 lon: 9.95112 facility: Novartis Investigative Site city: Hof zip: 95028 country: Germany lat: 50.31297 lon: 11.91261 facility: Novartis Investigative Site city: Homburg zip: 66421 country: Germany lat: 49.32637 lon: 7.33867 facility: Novartis Investigative Site city: Ilsede zip: 31241 country: Germany lat: 52.2634 lon: 10.19922 facility: Novartis Investigative Site city: Jena zip: 07740 country: Germany lat: 50.92878 lon: 11.5899 facility: Novartis Investigative Site city: Kaiserslautern zip: 67655 country: Germany lat: 49.443 lon: 7.77161 facility: Novartis Investigative Site city: Karlsruhe zip: 76133 country: Germany lat: 49.00937 lon: 8.40444 facility: Novartis Investigative Site city: Karlsruhe zip: 76135 country: Germany lat: 49.00937 lon: 8.40444 facility: Novartis Investigative Site city: Kassel zip: 34119 country: Germany lat: 51.31667 lon: 9.5 facility: Novartis Investigative Site city: Kempten zip: 87439 country: Germany lat: 47.72674 lon: 10.31389 facility: Novartis Investigative Site city: Kiel zip: 24105 country: Germany lat: 54.32133 lon: 10.13489 facility: Novartis Investigative Site city: Koblenz zip: 56068 country: Germany lat: 50.35357 lon: 7.57883 facility: Novartis Investigative Site city: Koeln zip: 50671 country: Germany lat: 50.93333 lon: 6.95 facility: Novartis Investigative Site city: Koeln zip: 50935 country: Germany lat: 50.93333 lon: 6.95 facility: Novartis Investigative Site city: Koeln zip: 50937 country: Germany lat: 50.93333 lon: 6.95 facility: Novartis Investigative Site city: Koeln zip: 51067 country: Germany lat: 50.93333 lon: 6.95 facility: Novartis Investigative Site city: Kronach zip: 96317 country: Germany lat: 50.23963 lon: 11.33308 facility: Novartis Investigative Site city: Krumbach zip: 86381 country: Germany lat: 48.24182 lon: 10.3632 facility: Novartis Investigative Site city: Kulmbach zip: 95326 country: Germany lat: 50.10068 lon: 11.45032 facility: Novartis Investigative Site city: Lebach zip: 66822 country: Germany lat: 49.41122 lon: 6.90988 facility: Novartis Investigative Site city: Leipzig zip: 04129 country: Germany lat: 51.33962 lon: 12.37129 facility: Novartis Investigative Site city: Leipzig zip: 04277 country: Germany lat: 51.33962 lon: 12.37129 facility: Novartis Investigative Site city: Loerrach zip: 79539 country: Germany lat: 47.61497 lon: 7.66457 facility: Novartis Investigative Site city: Lohsa/Weißkollm zip: 02999 country: Germany facility: Novartis Investigative Site city: Luebeck zip: 23538 country: Germany lat: 53.86893 lon: 10.68729 facility: Novartis Investigative Site city: Mainz zip: 55131 country: Germany lat: 49.98419 lon: 8.2791 facility: Novartis Investigative Site city: Mannheim zip: 68161 country: Germany lat: 49.4891 lon: 8.46694 facility: Novartis Investigative Site city: Mannheim zip: 68165 country: Germany lat: 49.4891 lon: 8.46694 facility: Novartis Investigative Site city: Marburg zip: 35037 country: Germany lat: 50.80904 lon: 8.77069 facility: Novartis Investigative Site city: Marktredwitz zip: 95615 country: Germany lat: 50.00443 lon: 12.08593 facility: Novartis Investigative Site city: Memmingen zip: 87700 country: Germany lat: 47.98372 lon: 10.18527 facility: Novartis Investigative Site city: Minden zip: 32429 country: Germany lat: 52.28953 lon: 8.91455 facility: Novartis Investigative Site city: Moenchengladbach zip: 41061 country: Germany lat: 51.18539 lon: 6.44172 facility: Novartis Investigative Site city: Moers zip: 47441 country: Germany lat: 51.45342 lon: 6.6326 facility: Novartis Investigative Site city: Muehlhausen zip: 99974 country: Germany facility: Novartis Investigative Site city: Muenster zip: 48145 country: Germany lat: 51.96236 lon: 7.62571 facility: Novartis Investigative Site city: Naunhof zip: 04683 country: Germany lat: 51.2777 lon: 12.58827 facility: Novartis Investigative Site city: Neuruppin zip: 16816 country: Germany lat: 52.92815 lon: 12.80311 facility: Novartis Investigative Site city: Neuss zip: 41462 country: Germany lat: 51.19807 lon: 6.68504 facility: Novartis Investigative Site city: Neustadt/Sachsen zip: 01844 country: Germany facility: Novartis Investigative Site city: Nordhausen zip: 99734 country: Germany lat: 51.5018 lon: 10.7957 facility: Novartis Investigative Site city: Nuernberg zip: 90419 country: Germany lat: 49.45421 lon: 11.07752 facility: Novartis Investigative Site city: Nuernberg zip: 90449 country: Germany lat: 49.45421 lon: 11.07752 facility: Novartis Investigative Site city: Offenbach zip: 63069 country: Germany lat: 50.10061 lon: 8.76647 facility: Novartis Investigative Site city: Offenburg zip: 77654 country: Germany lat: 48.47377 lon: 7.94495 facility: Novartis Investigative Site city: Oldenburg zip: 26121 country: Germany lat: 53.14118 lon: 8.21467 facility: Novartis Investigative Site city: Osnabrueck zip: 49076 country: Germany facility: Novartis Investigative Site city: Passau zip: 94036 country: Germany lat: 48.5665 lon: 13.43122 facility: Novartis Investigative Site city: Pforzheim zip: 75175 country: Germany lat: 48.88436 lon: 8.69892 facility: Novartis Investigative Site city: Plauen-Kauschwitz zip: 08525 country: Germany facility: Novartis Investigative Site city: Potsdam zip: 14467 country: Germany lat: 52.39886 lon: 13.06566 facility: Novartis Investigative Site city: Ravensburg zip: 88214 country: Germany lat: 47.78198 lon: 9.61062 facility: Novartis Investigative Site city: Regensburg zip: 93053 country: Germany lat: 49.01513 lon: 12.10161 facility: Novartis Investigative Site city: Rheine zip: 48431 country: Germany lat: 52.28509 lon: 7.44055 facility: Novartis Investigative Site city: Rodgau zip: 63110 country: Germany lat: 50.02627 lon: 8.88588 facility: Novartis Investigative Site city: Rostock zip: 18057 country: Germany lat: 54.0887 lon: 12.14049 facility: Novartis Investigative Site city: Rostock zip: 18059 country: Germany lat: 54.0887 lon: 12.14049 facility: Novartis Investigative Site city: Rotenburg zip: 27356 country: Germany lat: 53.11125 lon: 9.41082 facility: Novartis Investigative Site city: Ruesselsheim zip: 65428 country: Germany facility: Novartis Investigative Site city: Saarbruecken zip: 66113 country: Germany lat: 49.23262 lon: 7.0098 facility: Novartis Investigative Site city: Saarlouis zip: 66740 country: Germany lat: 49.31366 lon: 6.75154 facility: Novartis Investigative Site city: Salzgitter zip: 38226 country: Germany lat: 52.15256 lon: 10.33144 facility: Novartis Investigative Site city: Schorndorf zip: 73614 country: Germany lat: 48.80537 lon: 9.52721 facility: Novartis Investigative Site city: Schweinfurt zip: 97422 country: Germany lat: 50.04937 lon: 10.22175 facility: Novartis Investigative Site city: Schwerte zip: 58239 country: Germany lat: 51.44387 lon: 7.5675 facility: Novartis Investigative Site city: Schwäbisch-Hall zip: 74523 country: Germany lat: 49.11127 lon: 9.73908 facility: Novartis Investigative Site city: Soest zip: 59494 country: Germany lat: 51.57558 lon: 8.10619 facility: Novartis Investigative Site city: Stade zip: 21680 country: Germany lat: 53.59337 lon: 9.47629 facility: Novartis Investigative Site city: Stendal zip: 39576 country: Germany lat: 52.6069 lon: 11.85867 facility: Novartis Investigative Site city: Stolberg zip: 52222 country: Germany lat: 50.77368 lon: 6.22595 facility: Novartis Investigative Site city: Stuttgart zip: 70174 country: Germany lat: 48.78232 lon: 9.17702 facility: Novartis Investigative Site city: Stuttgart zip: 70199 country: Germany lat: 48.78232 lon: 9.17702 facility: Novartis Investigative Site city: Suhl zip: 98527 country: Germany lat: 50.60911 lon: 10.69401 facility: Novartis Investigative Site city: Torgau zip: 04860 country: Germany lat: 51.56016 lon: 12.99617 facility: Novartis Investigative Site city: Trier zip: 54290 country: Germany lat: 49.75565 lon: 6.63935 facility: Novartis Investigative Site city: Tuebingen zip: 72076 country: Germany lat: 48.52266 lon: 9.05222 facility: Novartis Investigative Site city: Ulm zip: 89073 country: Germany lat: 48.39841 lon: 9.99155 facility: Novartis Investigative Site city: Ulm zip: 89081 country: Germany lat: 48.39841 lon: 9.99155 facility: Novartis Investigative Site city: Vechta zip: 49377 country: Germany lat: 52.72632 lon: 8.28598 facility: Novartis Investigative Site city: Voelklingen zip: 66333 country: Germany facility: Novartis Investigative Site city: Weiden zip: 92637 country: Germany lat: 49.67682 lon: 12.15613 facility: Novartis Investigative Site city: Weinheim zip: 69469 country: Germany lat: 49.54887 lon: 8.66697 facility: Novartis Investigative Site city: Wetzlar zip: 35578 country: Germany lat: 50.56109 lon: 8.50495 facility: Novartis Investigative Site city: Wiesbaden zip: 65189 country: Germany lat: 50.08258 lon: 8.24932 facility: Novartis Investigative Site city: Wiesbaden zip: 65191 country: Germany lat: 50.08258 lon: 8.24932 facility: Novartis Investigative Site city: Wilhelmshaven zip: 26389 country: Germany lat: 53.52998 lon: 8.11253 facility: Novartis Investigative Site city: Wolfsburg zip: 38440 country: Germany lat: 52.42452 lon: 10.7815 facility: Novartis Investigative Site city: Worms zip: 67550 country: Germany lat: 49.63278 lon: 8.35916 facility: Novartis Investigative Site city: Wuerselen zip: 52146 country: Germany facility: Novartis Investigative Site city: Wuerzburg zip: 97080 country: Germany lat: 49.79391 lon: 9.95121 hasResults: False

 nctId: NCT06311370 id: 2023-0100 briefTitle: Acceptability, Feasibility, and Development of an AI Driven, Multi-sensor, Non-invasive Digital Mental Health Platform in Children With ADHD and Emotional Symptoms overallStatus: COMPLETED date: 2023-08-09 date: 2024-02-05 date: 2024-02-05 date: 2024-03-15 date: 2024-03-15 name: MaxisHealth class: INDUSTRY briefSummary: This is an observational study collecting data using a wearable to measure the biometric features in youth with Attention deficit hyperactivity disorder(ADHD) and Autism. conditions: ADHD conditions: Autism studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10 type: ACTUAL name: Observation measure: Emotion dysregulation sex: ALL minimumAge: 4 Years maximumAge: 7 Years stdAges: CHILD facility: The League School city: Brooklyn state: New York zip: 11203 country: United States lat: 40.6501 lon: -73.94958 hasResults: False

 nctId: NCT06311357 id: 100/2566 briefTitle: Percent Weight Change in the Medical Supplement Group of Early Breast Cancer overallStatus: RECRUITING date: 2023-07-12 date: 2024-04-26 date: 2024-04-30 date: 2024-03-15 date: 2024-03-15 name: Rajavithi Hospital class: OTHER_GOV briefSummary: The goal of this RCT is to compare percent weight change in early breast cancer who takes medical supplement or not, during treatment with chemotherapy (standard AC regimen).

The main question is

• the change of weight (%) before and after complete treatment of breast cancer therapy.

Participants will be randomized into 2 group

* intervention group - receive medical supplement daily during chemotherapy treatment.
* control group - Nutritional advise during chemotherapy treatment. conditions: Early Stage Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Ensure measure: Percent weight change measure: EORTC QLQ-C30 measure: Patient interpretation of the Patient-Generated Subjective Global Assessment measure: EORTC QLQ-BR23 sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rajavithi hospital status: RECRUITING city: Ratchathewi state: Bangkok zip: 10400 country: Thailand name: Meitinarth Juntong role: CONTACT phone: +66654415447 email: juntong.mei@gmail.com lat: 13.759 lon: 100.53358 hasResults: False

 nctId: NCT06311344 id: 2021-06 briefTitle: Filling Key Research Gaps With Clinical Implications in Mansonellosis and Schistosomiasis: a Network Approach overallStatus: RECRUITING date: 2021-04-14 date: 2024-03-31 date: 2024-03-31 date: 2024-03-15 date: 2024-03-15 name: IRCCS Sacro Cuore Don Calabria di Negrar class: OTHER briefSummary: This is an experimental, multicenter, non-profit study promoted by the Department of Infectious and Tropical Diseases of the IRCCS (Istituto di Ricerca e Cura a carattere scientifico) Sacro Cuore Don Calabria of Negrar which aims to evaluate the presence of endosymbiont Wolbachia in circulating microfilariae obtained from biological samples of individuals infected with M .perstans and the presence of infection with hybrid Schistosoma species in the population of Schistosoma eggs isolated from biological samples of patients with active schistosomiasis. conditions: Schistosoma Mansoni studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 200 type: ESTIMATED name: Molecular biology analyses measure: Number of M. perstans microfilariae measure: Percentage of M. perstans microfilariae measure: Number of Schistosoma eggs measure: Percentage of Schistosoma eggs measure: Number of samples positive for Wolbachia measure: Percentage of samples positive for Wolbachia measure: Number of samples positive for Schistosoma hybrid species measure: Percentage of samples positive for Schistosoma hybrid species measure: Identification of hybrid species of Schistosoma spp. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Sacro Cuore Don Calabria hospital status: RECRUITING city: Negrar state: Verona zip: 37024 country: Italy name: Elena Pomari role: CONTACT phone: +390456013111 email: elena.pomari@sacrocuore.it name: Elena Pomari role: PRINCIPAL_INVESTIGATOR name: Francesca Tamarozzi role: SUB_INVESTIGATOR name: Bonnie Webster role: SUB_INVESTIGATOR lat: 45.52918 lon: 10.93899 hasResults: False

 nctId: NCT06311331 id: restor3d-007 briefTitle: Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2031-05 date: 2031-05 date: 2024-03-15 date: 2024-03-15 name: Restor3D class: INDUSTRY briefSummary: This is a Humanitarian Device Exemption (HDE) approved device. The purpose of this study is to evaluate the continued safety and probable benefit of the restor3d Total Talus Replacement device in commercial use. conditions: Avascular Necrosis of the Talus conditions: Talar Osteochondral Defect of Ankle conditions: Talar Dysfunction studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Total Talus Replacement (TTR) measure: Proportion of participants who pass a composite of safety and probable benefit outcomes measure: Change in perceived pain from baseline measure: Change in Foot and Ankle Outcome Score (FAOS) Composite score from baseline measure: Change in Foot and Ankle Outcome Score (FAOS) pain subscale score from baseline measure: Change in Foot and Ankle Outcome Score (FAOS) other symptoms subscale score from baseline measure: Change in Foot and Ankle Outcome Score (FAOS) activities of daily living (ADL) subscale score from baseline measure: Change in Foot and Ankle Outcome Score (FAOS) sports/recreation subscale score from baseline measure: Change in Foot and Ankle Outcome Score (FAOS) quality of life (QOL) subscale score from baseline measure: Change in ankle range of motion (ROM) from baseline measure: Proportion of procedure-related Serious Adverse Events measure: Proportion of Adverse Events sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06311318 id: Department of surgery MED CMU briefTitle: Post-operative Lower Eyelid Massage for Prevention of the Lower Eyelid Scare Contracture After Subciliary Approach acronym: RCT overallStatus: COMPLETED date: 2016-11-01 date: 2019-11-30 date: 2020-09-30 date: 2024-03-15 date: 2024-03-15 name: Chiang Mai University class: OTHER briefSummary: Patients were randomly allocated to the lower eyelid massage (experimental) or standard care (control) groups. The massage group received post-operative instructions. Data on demographics, injury profiles, lower eyelid scar contracture (graded by GLESCO criteria), eyelid malpositioning, comfort scores, and complications were gathered over a 6-month follow-up. conditions: Zygomatic and Lefort II Fractures conditions: Infraorbital Rim Fixation conditions: Subciliary Approach Repair studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized controlled trial enrolled patients with traumatic facial fractures slated for subciliary approach repair. Patients were randomly allocated to the lower eyelid massage (experimental) or standard care (control) groups. The massage group received post-operative instructions. Data on demographics, injury profiles, lower eyelid scar contracture (graded by GLESCO criteria), eyelid malpositioning, comfort scores, and complications were gathered over a 6-month follow-up. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Patients were randomly assigned, using concealed block of four randomization, to either the experimental group receiving lower eyelid massage or the control group receiving standard care. While the authors, acting as massage trainers, were unblinded, an independent plastic surgeon, serving as the assessor, remained blinded to the study interventions. whoMasked: OUTCOMES_ASSESSOR count: 59 type: ACTUAL name: lower eyelid massage measure: Grading of Lower Eyelid Scar Contracture (GLESCO) measure: Grading of lower eyelid malpositioning measure: Comfort scores sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06311305 id: Soh-med-24-03-07MS briefTitle: Does Early Laparoscopic Cholecystectomy After ERCP Reduce the Risk of Complications overallStatus: RECRUITING date: 2024-03-01 date: 2024-08-01 date: 2024-08-20 date: 2024-03-15 date: 2024-03-15 name: Sohag University class: OTHER briefSummary: Gallstones have been recognised since antiquity and have been found during autopsies of Egyptian mummies. Following the first successful open cholecystectomy in 1882, it was Eric Muhe, a German surgeon, who performed the first laparoscopic cholecystectomy (Lapara, the flank; and skopein, to examine) in 1985.

The common mechanism of gallstone formation includes cholesterol hypersecretion, alteration in intestinal bile salt, cholesterol absorption and gall bladder hypokinesia, which leads to bile cholesterol supersaturation and nucleation.

Incidence of CBD stones in cases of cholelithiasis is around 3.4%-15%.2 Choledocholithiasis can either be primary or secondary. Secondary Choledocholithiasis being more common occurs due to stones originating in gallbladder and then migrating through cystic duct to CBD. Primary bile duct stones originate from within bile ducts and are more common in Asian populations. These stones are associated with biliary stasis and bacteria. conditions: Cholelithiases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: we aim to assess if the early laparoscopic cholecystectomy after ERCP can reduce the risks or complications primaryPurpose: TREATMENT masking: NONE maskingDescription: NONE (open label single group) count: 30 type: ESTIMATED name: Early Laparoscopic cholecystectomy measure: bile leakage measure: operative time measure: intraoperative bleeding measure: sepsis sex: ALL minimumAge: 15 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag University status: RECRUITING city: Sohag zip: 82511 country: Egypt name: Abdulla M Ahmed, master role: CONTACT phone: 01006546957 phoneExt: 002 email: abdallah_mohamed_ex@med.sohag.edu.eg name: Abdulla M Ahmed, master role: PRINCIPAL_INVESTIGATOR lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06311292 id: STUDY22090138 briefTitle: Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis overallStatus: RECRUITING date: 2024-04 date: 2024-12 date: 2025-06 date: 2024-03-15 date: 2024-04-15 name: Daniel J. Weiner class: OTHER briefSummary: This is a small pilot study with the goal of identifying a superior sputum collection method in Cystic Fibrosis patients unable to produce a sputum.

Participants will use the Volara System during clinic visit in an attempt to produce sputum. conditions: Cystic Fibrosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE maskingDescription: No parties will be prevented from having knowledge of the Volara System use. count: 20 type: ESTIMATED name: Volara System measure: Sufficient sputum quantity for a pellet sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UPMC Presbyterian Hospital status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15213 country: United States name: Elizabeth Hartigan, MPH, RN role: CONTACT phone: 412-692-7060 email: elizabeth.hartigan@chp.edu name: Jamie Adams, BS, RRT role: CONTACT email: adamsjm2@upmc.edu name: Daniel Weiner, MD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06311279 id: Soh-Med-24-03-01MD briefTitle: End to End Versus Side to End Anastomosis After Anterior Resection of Cancer Rectum overallStatus: RECRUITING date: 2024-03-05 date: 2025-01-01 date: 2025-03-20 date: 2024-03-15 date: 2024-03-15 name: Sohag University class: OTHER briefSummary: Comparison between end to end and side to end anastomosis after anterior resection of cancer rectum and compare the outcomes of both surgical techniques. The main outcomes were bowel functional outcomes and QoL. Bowel functional outcomes mainly included three indexes: stool frequency, urgency, incomplete defecation, and incontinence. The secondary outcomes were surgical outcomes including operative time, postoperative hospital stay, postoperative complications, reoperation, and mortality. conditions: Rectum Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Comparison between end to end and side to end anastomosis after anterior resection of cancer rectum and compare the outcomes of both surgical techniques. The main outcomes were bowel functional outcomes and QoL. Bowel functional outcomes mainly included three indexes: stool frequency, urgency, incomplete defecation, and incontinence. The secondary outcomes were surgical outcomes including operative time, postoperative hospital stay, postoperative complications, reoperation, and mortality primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: randomized comparative clinical trial whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Anterior resection of Rectal cancer measure: Operative time measure: Anastomotic leakage measure: hospital stay measure: Mortality measure: Anastomotic leak amount sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag university status: RECRUITING city: Sohag zip: 82511 country: Egypt name: Nabil A Al-Ameer, MD role: CONTACT phone: 1118416290 email: Nabil.abdelnaser@med.sohag.edu.eg name: Ahmed G Hassanein, MD role: CONTACT phone: 1552538300 phoneExt: 0020 email: ethics@med.sohag.edu.eg lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06311266 id: 34-424 ex 21/22 briefTitle: Robotic Endoscopic Neurosurgical Interventions acronym: RENI overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-03 date: 2025-10 date: 2024-03-15 date: 2024-03-15 name: Medical University of Graz class: OTHER briefSummary: Endoscopic operations have become increasingly important in the field of neurosurgery over the past decade and require a high degree of precision. Current methods for setting the planned trajectory only offer limited precision due to the manual control, which can lead to complications.

The EndoGuide robot is a modular positioning device for controlling endoscopic instruments, which can use radiological data from neuronavigation to align the trajectory in real time with an accuracy of \<0.1mm.

The previous model of the robot is currently approved for interventional radiology and positioning of electrodes and catheters in the field of neurosurgery and is now to be tested in endoscopic neurosurgery.

The investigators therefore expect not only an increase in the accuracy of endoscopic interventions, but also a reduction in morbidity. conditions: Robot for Endoscopic Neurosurgical Interventions studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: prospective, randomized, single center cohort trial primaryPurpose: DEVICE_FEASIBILITY masking: SINGLE maskingDescription: Due to the surgical workflow (using the robotic guided device or not) the performing surgical team will not be blinded to the allocated group. However, investigators will be blinded to the allocation of the patients. whoMasked: PARTICIPANT count: 19 type: ESTIMATED name: Robotic endoscopic neurosurgical intervention measure: Target Error (TE) measure: Adverse Effect sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06311253 id: 2024-LACTOFERRINPREGNANT briefTitle: Non-surgical Periodontal Treatment With Adjunctive Use of Lactoferrin Contained in Toothpaste and Mouthwash overallStatus: ENROLLING_BY_INVITATION date: 2024-03-20 date: 2024-11 date: 2024-11 date: 2024-03-15 date: 2024-04-26 name: University of Pavia class: OTHER briefSummary: The aim of the study is to assess the effect of lactoferrin in LBC complex can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients. conditions: Periodontal Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Emoform Glic Toothpaste name: Emoform Glic Mouthwash measure: Change in Recession (R) measure: Change in Plaque Index (Silness and Loe, 1964) measure: Change in Bleeding on Probing (BoP) measure: Change in Probing Pocket Depth (PPD) measure: Change in modified Marginal Gingival Index (mMGI) measure: Change in Papillary Marginal Gingival Index (PMGI) measure: Change in Plaque Control Record (PCR%) measure: Change in Clinical Attachment Loss (CAL) sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia city: Pavia state: Lombardy zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06311240 id: 02-24-108-003 briefTitle: Chronic Pain in Patients in Hemodialysis acronym: DolERC overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-09 date: 2024-03-15 date: 2024-03-15 name: Cardenal Herrera University class: OTHER name: Consorci Sanitari de Terrassa briefSummary: Pain is one of the most common symptoms among patients with End Stage Renal Disease (ESRD), and often goes unrecognized or inadequately managed in hemodialysis patients. More than 50% of patients undergoing hemodialysis suffer from pain, with 75% of them being treated ineffectively due to healthcare professionals\&amp;#39; lack of awareness of this symptom. Therefore, pain management in this population is a complex and challenging task for healthcare providers. The most prevalent pain syndromes in hemodialysis patients include musculoskeletal disorders, metabolic neuropathies, in addition to typical intradialytic pain.

The aim of this study is to assess the presence and characteristics of chronic pain in patients with ESRD undergoing hemodialysis to determine whether it is relevant to include the management of chronic pain in the holistic treatment (physical activity, nutrition, and psychological support) already being implemented in various studies for these patients. conditions: Chronic Pain conditions: Chronic Kidney Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Stress level assessed by the salivary cortisol test measure: Stress level assessed by the perceived stress scale (PSS) measure: Self- efficacy assessed by questionnaire measure: Quality of sleep assessed by Pittsburgh Sleep Quality Index measure: The impact of headaches on life assessed by Headache Impact Test-6 measure: Anxiety and depression assessed by Hospital anxiety and depression scale (HADS) measure: Aspects of catastrophic cognitions about pain-rumination, magnification, and helplessness assessed by The Pain Catastrophizing Scale (PCS) measure: Chronic pain assessd by Chronic Pain Grade Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Consorci Sanitari de Terrassa city: Terrassa state: Barcelona zip: 08227 country: Spain name: Vicent Esteve-Simó, PhD role: CONTACT phone: 00 34 937310007 email: vesteve@cst.cat lat: 41.56667 lon: 2.01667 facility: Universidad Cardenal Herrera-CEU, CEU Universities city: Alfara del Patriarca state: Valencia zip: 46115 country: Spain name: Eva Segura Orti, PhD role: CONTACT phone: 0034961369000 phoneExt: 64439 email: ESEGURA@UCHCEU.ES lat: 39.55 lon: -0.38333 hasResults: False

 nctId: NCT06311227 id: NCI-2024-01904 id: NCI-2024-01904 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 10637 type: OTHER domain: National Cancer Institute LAO id: 10637 type: OTHER domain: CTEP briefTitle: Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2025-07-01 date: 2025-07-01 date: 2024-03-15 date: 2024-03-15 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II trial tests how well venetoclax works in treating patients with hairy cell leukemia that has come back after a period of improvement (relapsed). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. conditions: Recurrent Hairy Cell Leukemia conditions: Recurrent Hairy Cell Leukemia Variant studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Biospecimen Collection name: Bone Marrow Aspiration name: Bone Marrow Biopsy name: Computed Tomography name: Magnetic Resonance Imaging name: Venetoclax measure: Objective response rate measure: Complete remission (CR) rate measure: Minimal residual disease (MRD)-negative CR rate measure: MRD negativilty measure: Incidence of adverse events measure: Complete response duration measure: MRD-negative survival measure: TP53 mutations and other mutations measure: Whole exome sequencing of relapsed HCL/HCLv samples sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06311214 id: NCI-2024-01903 id: NCI-2024-01903 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 10397 type: OTHER domain: University of Texas MD Anderson Cancer Center LAO id: 10397 type: OTHER domain: CTEP id: UM1CA186688 type: NIH link: https://reporter.nih.gov/quickSearch/UM1CA186688 briefTitle: Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The ADC MATCH Screening and Treatment Trial) overallStatus: NOT_YET_RECRUITING date: 2024-06-21 date: 2024-10-31 date: 2024-10-31 date: 2024-03-15 date: 2024-03-15 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II ADC MATCH screening and multi-sub-study treatment trial is evaluating whether biomarker-directed treatment with one of three antibody-drug conjugates (ADCs) (sacituzumab govitecan, enfortumab vedotin, and trastuzumab deruxtecan) works in treating patients with solid tumor cancers that have high expression of the Trop-2, nectin-4, or HER2 proteins and that may have spread from where they first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced) or to other places in the body (metastatic). Precision medicine is a form of medicine that uses information about a person's genes, proteins, and environment to prevent, diagnose, or treat disease in a way that is tailored to the patient. ADCs such as sacituzumab govitecan, enfortumab vedotin, and trastuzumab deruxtecan are monoclonal antibodies attached to biologically active drugs and are a form of targeted therapy. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a drug called govitecan. Sacituzumab attaches to a protein called Trop-2 on the surface of tumor cells and delivers govitecan to kill them. Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of tumor cells. Enfortumab attaches to a protein called nectin-4 on tumor cells in a targeted way and delivers vedotin to kill them. Trastuzumab deruxtecan is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Personalized treatment with sacituzumab govitecan, enfortumab vedotin, or trastuzumab deruxtecan may be an effective treatment option for patients with advanced or metastatic solid tumors that screen positive for high expression of Trop-2, nectin-4, or HER2, respectively. conditions: Advanced Malignant Solid Neoplasm conditions: Metastatic Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 500 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Echocardiography name: Electronic Health Record Review name: Enfortumab Vedotin name: Immunohistochemistry Staining Method name: Magnetic Resonance Imaging name: Multigated Acquisition Scan name: Sacituzumab Govitecan name: Trastuzumab Deruxtecan measure: Frequency of high protein expression in patients with high ribonucleic acid (RNA) expression of each antibody-drug conjugate target (screening protocol) measure: Objective response rate (treatment cohorts) measure: Frequency that patients with high RNA and immunohistochemistry target expression receive cohort treatment on study (screening protocol) measure: Progression free survival (treatment cohorts) measure: Overall survival (treatment cohorts) measure: Time to progression (treatment cohorts) measure: Incidence of adverse events (treatment cohorts) measure: RNA expression of targets of interest (TOIs) (treatment cohorts) measure: Temporal tumor heterogeneity (treatment cohorts) measure: Potential predictive biomarkers and other molecular features (treatment cohorts) measure: Pharmacodynamic changes in the tumor and microenvironment (treatment cohorts) measure: Mechanisms of acquired resistance (treatment cohorts) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06311201 id: P.T.REC/012/004256 briefTitle: Effect of Pilates Exercises on Diastasis Recti Abdominis in Postpartum Women overallStatus: COMPLETED date: 2023-09-26 date: 2024-01-26 date: 2024-01-26 date: 2024-03-15 date: 2024-03-19 name: Cairo University class: OTHER briefSummary: The purpose of the study was to investigate the effect of Pilates exercises on diastasis recti abdominis in postpartum women. conditions: Diastasis Recti studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 50 type: ACTUAL name: Abdominal belt name: Pilates exercises measure: Measurement of separation between the two-rectus abdominis muscles above the umbilicus at rest measure: Measurement of separation between the two-rectus abdominis muscles above the umbilicus during contraction measure: Measurement of separation between the two-rectus abdominis muscles at level of the umbilicus at rest measure: Measurement of separation between the two-rectus abdominis muscles at level of the umbilicus during contraction measure: Measurement of separation between the two-rectus abdominis muscles below the umbilicus at rest measure: Measurement of separation between the two-rectus abdominis muscles below the umbilicus during contraction measure: Assessment of trunk flexion strength measure: Assessment of static trunk flexion endurance measure: Assessment of functional status sex: FEMALE minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Cairo University city: Giza country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06311188 id: HUM00240243 id: 1R21MD016940-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R21MD016940-01A1 briefTitle: Exploring PTSD Symptoms, Barriers and Facilitators to Mindfulness overallStatus: NOT_YET_RECRUITING date: 2024-04-14 date: 2024-11-30 date: 2025-01-31 date: 2024-03-15 date: 2024-03-25 name: University of Michigan class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The purpose of this study is to investigate justice-involved Black/African American female adolescents' (JI BAFAs; N=35) self-reported outcomes: stress, posttraumatic stress disorder (PTSD), recidivism, etc., as well as their parents/caregivers' (P/Cs; N=35) stress and pre- and post- intervention results along with their views of an adapted intervention. conditions: Stress conditions: Trauma conditions: PTSD conditions: HPA studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single arm trial primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: ITR Healing intervention measure: PTSD Screen measure: PTSD Checklist measure: Stress Psychosocial measure: Stress Physiological measure: Parent/Caregiver-Child Relationship measure: Five Facet Mindfulness Questionnaire (FFMQ) measure: Recidivism measure: Personal Agency measure: Racial Identity measure: Parenting Stress measure: MoCA screen measure: CESD - Depression screen sex: ALL minimumAge: 14 Years maximumAge: 90 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06311175 id: H20-0114 briefTitle: Diet Tracking Prescriptions for Weight Loss overallStatus: RECRUITING date: 2024-04-30 date: 2024-05-31 date: 2024-09-01 date: 2024-03-15 date: 2024-04-25 name: University of Connecticut class: OTHER briefSummary: Lifestyle interventions are effective at producing modest weight loss. One of the strongest predictors of weight loss is food tracking, which involves logging all food and beverage consumed each day in an effort to stay within a daily calorie goal. Standard lifestyle interventions prescribe daily food tracking for the length of the program which can range from 3-24 months. This can be a taxing prescription that is not feasible to do long term for many people. The purpose of this pilot feasibility randomized trial is to test the feasibility of 3 tracking prescriptions during an 8 week digital weight loss intervention: 1) tracking daily, 2) tracking two weeks on and one week off, 3) tracking every other week. Feasibility is defined as tracking prescription compliance, burden, acceptability, and perceived efficacy, and tracking self-efficacy. Diet tracking will be evaluated one month after the intervention ends so that groups can be compared on diet tracking maintenance. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to one of three intervention groups in parallel for the duration of the study primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 108 type: ESTIMATED name: Dietary Tracking Prescription measure: Compliance with diet tracking prescription measure: Persistence with diet tracking prescription measure: Burden of tracking prescription measure: Acceptability of tracking prescription measure: Perceived efficacy of tracking prescription measure: Self-efficacy of diet tracking measure: Diet Tracking One Month Post-Intervention sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Connecticut status: RECRUITING city: Storrs state: Connecticut zip: 06269 country: United States name: Sherry Pagoto, PhD role: CONTACT phone: 860-486-2313 email: sherry.pagoto@uconn.edu name: Sherry Pagoto, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.80843 lon: -72.24952 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-09-14 uploadDate: 2024-01-03T11:42 filename: Prot_000.pdf size: 518051 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-09-14 uploadDate: 2024-03-12T13:35 filename: ICF_001.pdf size: 296855 hasResults: False

 nctId: NCT06311162 id: 2023-01615 briefTitle: Early Life Intervention in Pediatrics Supported by E-health - SMOKE acronym: ELIPSE-II overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2027-08-31 date: 2028-07-31 date: 2024-03-15 date: 2024-03-20 name: Insel Gruppe AG, University Hospital Bern class: OTHER name: University of Bern briefSummary: Unrestricted parental smoking habits are lifestyle risk behaviors associated with chronic, systemic inflammation, which promotes the pathogenesis of non-communicable diseases (NCDs). Exposure to secondhand tobacco smoke in early life contributes to the development of specific NCDs in children, i.e. asthma. Early preventive measures to improve lifestyle behavior in parents are therefore of utmost importance. The aim of ELIPSE-II is to assess whether an eHealth application intervention for parents is feasible and efficacious in lowering levels of urinary cotinine as a measure of second-hand smoke exposure in their children . conditions: Smoking Reduction conditions: Asthma in Children conditions: Wheezing conditions: Non-Communicable Disease conditions: Life Style conditions: Behavior, Smoking studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single-blind randomized controlled parallel-group clinical trial primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: The study team members who are conducting assessments on the participants remain blinded to the treatment allocation. whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 160 type: ESTIMATED name: Life-Style app name: Sham Comparator measure: Change from baseline in urinary levels of cotinine in children measure: Change from baseline in urinary levels of cotinine in children measure: Change from baseline in protective measures taken by parents to protect children from second-hand smoke exposure measure: Acceptance and usability of the app (parent reported outcome) measure: Acceptance of the app measure: Usability of the app measure: Number of episodes of airway disease in children measure: Frequency of inhalant medications or antibiotics required for airway disease in children measure: Amount of inhalant medications or antibiotics required for airway disease in children measure: Number of episodes of severe airway disease in children requiring hospitalization measure: Change from baseline in parental smoking intensity (number of cigarettes smoked per day) sex: ALL maximumAge: 5 Years stdAges: CHILD facility: Department of Paediatrics, Inselspital, Bern University Hospital city: Bern zip: 3010 country: Switzerland name: Julian Jakob, MD role: CONTACT phone: +41 31 632 12 93 email: julian.jakob@insel.ch name: Matthias V. Kopp, Prof, MD role: CONTACT phone: +41 31 66 4 13 51 email: matthias.kopp@insel.ch name: Julian Jakob, MD role: SUB_INVESTIGATOR name: Andrea Wyssen, PhD role: SUB_INVESTIGATOR lat: 46.94809 lon: 7.44744 hasResults: False

 nctId: NCT06311149 id: 479/2023/Oss/AOUFe briefTitle: Multicenter Evaluation of Patients Using LATITUDE Monitoring System acronym: Multitude overallStatus: RECRUITING date: 2023-12-01 date: 2043-12-31 date: 2043-12-31 date: 2024-03-15 date: 2024-03-15 name: University Hospital of Ferrara class: OTHER briefSummary: The Multitude is a registry of patients who receive commercially available CIEDs that remotely communicate through the LATITUDE monitoring system and transfer data to a central database.

The registry is designed to constitute a shared environment for the collection, management, analysis and reporting of clinical and diagnostic data, adopted by a network of European scientifically-motivated physicians who use rhythm management diagnostic and therapeutic solutions from Boston Scientific in their clinical practice.

The Multitude study will facilitate the sharing of scientific proposals within a large network of researchers, and it will allow researchers to record the experience with medical devices throughout the device and patient lifecycle. conditions: Cardiovascular Diseases conditions: Arrhythmias, Cardiac conditions: Heart Failure conditions: Sudden Cardiac Death studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20000 type: ESTIMATED measure: Mortality measure: Hospitalization measure: Device therapy measure: Device-related complications sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliero-Universitaria di Ferrara status: RECRUITING city: Ferrara zip: 44124 country: Italy name: Matteo Bertini, MD, PhD role: CONTACT email: brtmtt2@unife.it lat: 44.83804 lon: 11.62057 facility: Policlinico Federico II status: RECRUITING city: Napoli country: Italy name: Antonio Rapacciuolo role: CONTACT email: antonio.rapacciuolo@unina.it lat: 40.85216 lon: 14.26811 hasResults: False

 nctId: NCT06311136 id: PEAK briefTitle: Effectiveness of an Ecological Momentary Emotion Regulation Intervention overallStatus: RECRUITING date: 2024-01-12 date: 2024-12 date: 2024-12 date: 2024-03-15 date: 2024-03-18 name: Heidelberg University class: OTHER briefSummary: This two-armed randomized controlled trial aims to investigate the effectiveness of an emotion regulation intervention in individuals with and without depressive disorders. The study encompasses participants diagnosed with mild to moderate major depression or persistent depressive disorder and healthy controls without a current depressive disorder.

Participants will be randomly assigned to either the intervention group, receiving a valence-specific emotion regulation intervention in daily life, or a monitoring-only control group. The valence-specific intervention supports the implementation of different emotion regulation strategies based on whether a person is experiencing mainly positive or negative emotions. In contrast, participants in the control group will solely monitor their positive and negative emotions and the strategies used to regulate them.

Outcome measures include emotion regulation ability, self-efficacy, and strategy use, depressive symptoms, positive and negative affect, and emotion beliefs (controllability, usefulness).

A second aim of the study is to compare beliefs about positive emotions and strategies to regulate them between individuals with and without current depressive disorders. Furthermore, the investigators aim to examine why individuals might choose unfavorable emotion regulation strategies even when feeling good. Therefore, another research question is, how emotion beliefs might explain emotion regulation strategy choice. conditions: Depressive Disorder, Major conditions: Persistent Depressive Disorder conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial with an Intervention Group and a Control Group without an intervention. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: During the treatment phase, both the intervention and monitoring-only control groups use a diary called "Positive Everyday Affect Knowledge". Participants are informed that the diary entries may include instructions for implementing specific emotion regulation strategies in their daily activities. However, this component of the procedure is not characterized explicitly as an intervention. This methodological consideration ensures that differences observed between the groups can be attributed to the intervention itself, rather than to differences in participants' expectations.

Clinical interviews will be conducted blindly. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Valence-Specific Ecological Momentary Intervention measure: Emotion Regulation Ability (Positive, Negative Emotions) measure: Emotion Regulation Self-Efficacy for Positive and Negative Emotions measure: Emotion Regulation Strategy Use in Positive and Negative Emotional Contexts measure: Depressive Symptoms measure: Positive and Negative Affect measure: Emotion Beliefs (Controllability, Usefulness) about Positive and Negative Emotions measure: Well-being measure: Life Satisfaction measure: Emotion Beliefs about Positive Emotions (Delay Happiness, Living in the Moment) measure: Emotion Beliefs about Positive Emotions (Fear of Happiness) measure: Negative Emotional Contrast Avoidance measure: Emotion Regulation Strategy Use measure: Self-Esteem measure: Locus of Control measure: Controllability Beliefs about Emotions measure: Anxiety Symptoms sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Heidelberg University status: RECRUITING city: Heidelberg zip: 69117 country: Germany name: Ilka Mueller, M.Sc. role: CONTACT phone: +496221/547362 email: ilka.mueller@psychologie.uni-heidelberg.de name: Luise Pruessner, M.Sc. role: CONTACT phone: +496221/547282 email: luise.pruessner@psychologie.uni-heidelberg.de lat: 49.40768 lon: 8.69079 hasResults: False

 nctId: NCT06311123 id: ISR IM047-059 briefTitle: Understanding Ozanimod's MOA Via Mass Cytometry in Ulcerative Colitis overallStatus: RECRUITING date: 2023-10-06 date: 2026-09-30 date: 2026-09-30 date: 2024-03-15 date: 2024-03-15 name: University of California, San Diego class: OTHER briefSummary: The goal of this observational study is to learn about the mechanism of action of ozanimod in patients with ulcerative colitis (UC). The main questions it aims to answer are:

1. Prospectively assess the effects of ozanimod on the cellular composition of intestinal lamina propria and blood by deep immunophenotyping (CyTOF) of immune cell subsets prior and after the drug's administration.
2. Determine whether changes in cell subsets observed via mass cytometry correlate with with clinical or histologic parameters of disease activity.

Colonic biopsies and peripheral blood samples will be collected from patients with UC before and after the onset of ozanimod.

Researchers will compare intestinal and peripheral leukocytes before and after the drug's administration. conditions: Ulcerative Colitis conditions: Ulcerative Colitis Chronic Moderate studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10 type: ESTIMATED measure: difference in leukocyte subsets sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California San Diego status: RECRUITING city: San Diego state: California zip: 92093-006 country: United States name: Jesus Rivera-Nieves, MD role: CONTACT phone: 858-534-5495 email: jriveran@ucsd.edu lat: 32.71533 lon: -117.15726 hasResults: False

 nctId: NCT06311110 id: #BC-11326 AM04 briefTitle: Impaired Toilet Training, LUTS and Bowel Dysfunction in Children With DCD overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-30 date: 2024-02-08 date: 2024-06-30 date: 2024-03-15 date: 2024-03-15 name: University Hospital, Ghent class: OTHER briefSummary: This cross-sectional case-control study aimed to determine whether there is a significant difference in the prevalence of impaired toilet training, LUTS, and functional bowel problems among children diagnosed with DCD and typically developing children (TDC). conditions: Developmental Coordination Disorder conditions: Lower Urinary Tract Symptoms conditions: Bowel Dysfunction studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 84 type: ESTIMATED name: Vancouver symptom score for dysfunctional elimination symptoms Questionnaire name: Developmental Coordination Disorder Questionnaire name: Questionnaire concerning impaired toilettraining and comorbities measure: Impaired toilet training measure: Daytime incontinence measure: Enuresis measure: Fecal incontinence measure: Toilet training difficulties measure: General bladder and bowel dysfunction sex: ALL minimumAge: 5 Years maximumAge: 8 Years stdAges: CHILD facility: Ghent University Hospital/Ghent University city: Ghent state: East Flanders zip: 9000 country: Belgium lat: 51.05 lon: 3.71667 hasResults: False

 nctId: NCT06311097 id: M402 briefTitle: Dairy Products to Your Gut and Brain acronym: YourGutBrain overallStatus: RECRUITING date: 2024-04-08 date: 2025-09 date: 2025-09 date: 2024-03-15 date: 2024-04-15 name: University of Copenhagen class: OTHER name: University of Aarhus name: APC Microbiome Ireland briefSummary: The goal of this intervention study is to compare the effects of fermented dairy and non-fermented dairy on bowel habits and cognitive performance in healthy women with defecations every other day or less. Furthermore, the study aims to explore underlying mechanisms linking the gut and the brain.

In addition, a sub-study will be conducted to explore differences in gut and brain measures between women with daily (reference group) and few (intervention group) weekly bowel movements, respectively, and to explore associations between measures of gut- and brain function. conditions: Healthy conditions: Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Two 4-week intervention periods separated by a washout period of at least 4 weeks.

The crossover intervention will include 60 participants. Another 40 participants will only complete the first (baseline) visit. primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: Fermented dairy name: Non-fermented dairy measure: Difference in change from baseline in defecation frequency between the interventions measure: Difference in change from baseline in cognitive performance between the interventions measure: Difference in change from baseline in phase-amplitude coupling between gastric slow-wave activity and cortical alpha activity between the interventions measure: Difference in change from baseline in whole gut transit time between the interventions measure: Difference in change from baseline in stool consistency between the interventions measure: Difference in change from baseline in stool moisture between the interventions measure: Difference in change from baseline in fecal abundance of Lactobacillus acidophilus between the interventions measure: Difference in change from baseline in self-reported gastrointestinal symptoms between the interventions measure: Difference in change from baseline in gut microbiota between the interventions measure: Difference in change from baseline in fecal pH between the interventions measure: Difference in change from baseline in breath hydrogen and methane levels between the interventions measure: Difference in change from baseline in biomarkers of colonic fermentation between the interventions measure: Difference in change from baseline in fecal short-chain fatty acids (SCFAs) between the interventions measure: Difference in change from baseline in fecal zonulin levels between the interventions measure: Difference in change from baseline in plasma levels of lipopolysaccharide-binding protein (LBP) between the interventions measure: Difference in change from baseline in gut metabolome between the interventions measure: Difference in change from baseline in urine metabolome between the interventions measure: Difference in change from baseline in plasma metabolome between the interventions measure: Difference in change from baseline in inflammatory biomarkers between the interventions measure: Difference in change from baseline in plasma levels of cortisol between the interventions measure: Difference in change from baseline in biomarkers of glucose and lipid metabolism between the interventions measure: Difference in change from baseline in appetite hormones between the interventions measure: Difference in change from baseline in plasma level of Brain Derived Neurotrophic Factor (BDNF) between the interventions measure: Difference in change from baseline in self-reported stress and mood between the interventions measure: Difference in change from baseline in self-reported sleeping patterns between the interventions measure: Difference in change from baseline in resting-state cortical connectivity between the interventions measure: Difference in change from baseline in event-related potentials evoked by a cognitive task between the interventions measure: Difference in change from baseline in quality of life between the interventions measure: Difference in change from baseline in habitual diet between the interventions sex: FEMALE minimumAge: 45 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Copenhagen, Department of Nutrition, Exercise and Sports status: RECRUITING city: Copenhagen country: Denmark name: Henrik M Roager, PhD role: CONTACT email: hero@nexs.ku.dk name: Anke Karabanov, PhD role: SUB_INVESTIGATOR lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06311084 id: 310211 briefTitle: IMAGINATOR 2.0: Co-design and Early Evaluation of a Novel Blended Digital Intervention Targeting Self-harm in Young People acronym: IMAG2 overallStatus: COMPLETED date: 2022-11-25 date: 2023-11-09 date: 2024-01-23 date: 2024-03-15 date: 2024-04-04 name: Imperial College London class: OTHER name: National Institute for Health Research, United Kingdom briefSummary: This study aims to investigate acceptability and feasibility of a new version of the Imaginator intervention, Imaginator 2.0, targeting self-harm behaviour in young people aged 12-25 under mental health services in the UK.

Following an initial proof-of-concept study of Imaginator (Di Simplicio et al., 2020), we co-designed a new version of the app that supports consolidation and practice of the techniques learnt in therapy, and adapted the protocol to be extended to younger adolescents.

Imaginator 2.0 uses 'functional imagery training', training in individuals to develop and use functional (that is, helpful) mental images to support an alternative behaviour instead of self-harm. Mental imagery is the process of picturing something in the mind, and mental images have strong emotional and motivational characteristics. Functional Imagery Training (FIT) within Imaginator helps young people imagine adaptive behaviours as an alternative to self-harm when dealing with distressing emotions. conditions: Self Injurious Behavior conditions: Adolescent Behavior Problem conditions: Child Behavior Problem conditions: Mental Health Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open ended feasibility and acceptability of novel blended digital psychological intervention primaryPurpose: TREATMENT masking: NONE count: 27 type: ACTUAL name: Imaginator 2.0 measure: Attrition measure: Treatment adherence measure: Scores on User Experience Questionnaire measure: Number of self harm episodes over 3 months measure: Craving Experiences Questionnaire measure: Difficulties in Emotion Regulation Scale measure: Depression, Anxiety, Stress Scale sex: ALL minimumAge: 12 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: West London NHS Trust city: London country: United Kingdom lat: 51.50853 lon: -0.12574 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-04-04 uploadDate: 2024-02-16T12:11 filename: Prot_000.pdf size: 1958833 hasResults: False

 nctId: NCT06311071 id: IR.SUMS.MED.REC.1401.200 briefTitle: The Predictive Value of Coronary Artery Calcium Score overallStatus: COMPLETED date: 2022-01-01 date: 2023-05-01 date: 2023-09-01 date: 2024-03-15 date: 2024-03-22 name: Shiraz University of Medical Sciences class: OTHER briefSummary: In this analytical prospective study 498 patients over 40 years with any cardiovascular symptoms and without pre-established coronary artery disease ( CAD) were enrolled. Patients underwent CT scans to measure coronary artery calcium score (CACS), and total calcium scores were recorded. Then, conventional coronary angiography was performed for all the participants as the gold standard for diagnosing CAD (defined as at least one stenotic coronary artery with ≥ 50%). Framingham risk score (FRS) was also estimated for all the patients conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 498 type: ACTUAL name: calcium score name: Invasive coronary angiography measure: coronary artery disease measure: coronary calcium score measure: cardiovascular risk score sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Javad Kojuri city: Shiraz state: Fars zip: 7134814336 country: Iran, Islamic Republic of lat: 29.61031 lon: 52.53113 hasResults: False

 nctId: NCT06311058 id: PRO00032531 briefTitle: Protein Supplementation After ACL Surgery overallStatus: RECRUITING date: 2024-02-16 date: 2026-12-01 date: 2027-12-01 date: 2024-03-15 date: 2024-04-02 name: The Methodist Hospital Research Institute class: OTHER briefSummary: The purpose of the study is to assess the longitudinal post-operative care effects of protein supplementation on muscle atrophy in the post-operative period following ACL reconstruction. The main outcome will be muscle size/mass as measured using dual energy x-ray absorptiometry (DEXA) scanning. The primary objective is to assess for any beneficial impact of protein supplementation, with implications of standardizing a recommended protocol for protein supplementation after ACL reconstruction.

Secondary outcomes will be to evaluate the survey data from the KOOS JR and Tampa Scale surveys, as well as functional measures recorded during physical therapy. conditions: ACL Reconstruction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Subjects are randomized to 1 of 3 intervention groups primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE maskingDescription: This is a double-blinded randomized controlled trial. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 102 type: ESTIMATED name: Whey protein isolate name: Protein + BAA name: Placebo measure: Muscle mass measure: Patient Reported Outcomes measure: Patient Reported Outcomes sex: ALL minimumAge: 16 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Houston Methodist status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Haley Goble, MHA role: CONTACT phone: 713-441-3930 email: hmgoble@houstonmethodist.org name: Robert A Jack, MD role: SUB_INVESTIGATOR name: Patrick C McCulloch, MD role: PRINCIPAL_INVESTIGATOR name: David M Lintner, MD role: SUB_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06311045 id: 23-01469 briefTitle: Obstructive Sleep Apnea (OSA) and Sex-Specific Responses to N-acetylcysteine (NAC) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-06 date: 2028-12 date: 2024-03-15 date: 2024-03-15 name: NYU Langone Health class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: This is a randomized controlled trial (RCT) of 4 weeks of study supplement N-acetylcysteine (NAC) versus placebo in persons with significant obstructive sleep apnea (OSA) who are receiving positive airway pressure therapy (PAP), the standard of care therapy. The purpose of the study is to determine if NAC is associated with sex-specific changes in overnight oxidative stress, inflammation, as well as endothelial dysfunction in persons with OSA. conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 206 type: ESTIMATED name: N-acetylcysteine (NAC) name: Placebo name: Positive Airway Pressure (PAP) Therapy measure: Percent Change in Overnight Levels of Glutathione (GSH) measure: Mean Change in Pre- to Post-Sleep GSH Levels measure: Mean Change in Pre- to Post-Sleep GSH Levels measure: Ratio of GSH to oxidized GSH (GSSG) (GSH:GSSG) measure: Ratio of GSH to oxidized GSH (GSSG) (GSH:GSSG) measure: 8-Isoprostane Level measure: 8-Isoprostane Level measure: Plasma Nitrate Level measure: Plasma Nitrate Level measure: Plasma Nitrite Level measure: Plasma Nitrite Level measure: Organic Nitrite Level measure: Organic Nitrite Level measure: Interleukin 6 (IL-6) Level measure: Interleukin 6 (IL-6) Level measure: Tumor Necrosis Factor-alpha (TNFα) Receptor-1 (TNFα-R1) Level measure: Tumor Necrosis Factor-alpha (TNFα) Receptor-1 (TNFα-R1) Level measure: Tumor Necrosis Factor-alpha (TNFα) Receptor-2 (TNFα-R2) Level measure: Tumor Necrosis Factor-alpha (TNFα) Receptor-2 (TNFα-R2) Level measure: Reactive Hyperemia Index (RHI) Score measure: Reactive Hyperemia Index (RHI) Score measure: Epworth Sleepiness Scale (ESS) Score measure: Epworth Sleepiness Scale (ESS) Score measure: Insomnia Severity Index (ISI) Score measure: Insomnia Severity Index (ISI) Score measure: Fatigue Severity Scale (FSS) Score measure: Fatigue Severity Scale (FSS) Score measure: Pittsburgh Sleep Quality Index (PSQI) Score measure: Pittsburgh Sleep Quality Index (PSQI) Score sex: ALL minimumAge: 55 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06311032 id: 22-01227 briefTitle: Clinician Decision Making Regarding Surveillance for Low-risk Intraductal Papillary Mucinous Neoplasms of The Pancreas overallStatus: COMPLETED date: 2023-03-29 date: 2023-06-28 date: 2023-07-28 date: 2024-03-15 date: 2024-03-15 name: NYU Langone Health class: OTHER briefSummary: The main objective of this study is to determine how physicians make decisions regarding surveillance of Intraductal Papillary Mucinous Neoplasm's (IPMN) of the pancreas. conditions: Surgery Risk Assessment studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 72 type: ACTUAL measure: Number of Decisions to Stop Surveillance Imaging measure: Number of Decisions to Continue Surveillance Imaging sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06311019 id: 791572 briefTitle: The Effects of CGM and Connected Pen in T2DM Treated With Multiple Daily Insulin Injections acronym: Dia2tech overallStatus: RECRUITING date: 2024-02-27 date: 2025-09-01 date: 2026-06-01 date: 2024-03-15 date: 2024-03-15 name: Klavs Würgler Hansen class: OTHER name: Steno Diabetes Center Aarhus, Denmark briefSummary: The aim of the study is to evaluate the effect of a combination of 12 months treatment with CGM (Freestyle Libre 2) with hypo and hyper alert in combination with a smart pen for bolus insulin (NOVOpen6) on HbA1c and time in range (TIR) in T2DM patients with baseline HbA1c \>53 mmol/mol (7. 0%, eAG 8,6 mmol/l) as compared with standard care. conditions: Type 2 Diabetes Treated With Insulin studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 104 type: ESTIMATED name: Continuous glucose monitoring and use of connected insulinpen for bolus insulin measure: Change in Haemoglobin A1c measure: Change Time in range measure: Change in Time above range measure: Change in Time below range measure: Mean glucose measure: Standard deviation measure: Change in CV measure: Change in Time with rapid glucose change measure: Change in ARRC measure: Fraction of patients with increased number of bolus insulin per day measure: Fingerprick glucose measurement measure: Glucose views on mobile phone measure: Use of Novopen 6 memory function measure: WHO-5 measure: Diabetes Distress Scale measure: Revised short form of hypoglycaemia Fear Survey measure: eHealth literacy questionnaire (eHLQ), measure: The Glucose Monitoring Satisfaction Questionnaire measure: Diabetes Treatment Satisfaction Questionnaire (DTSQ) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Steno Diabetes Center Aarhus status: NOT_YET_RECRUITING city: Aarhus zip: 8000 country: Denmark name: Katrine B Gørlitz, MD role: CONTACT phone: +45 24210787 email: KAGOER@rm.dk name: Søren Gregersen, Professor role: CONTACT phone: +45 30134245 email: soeren.gregersen@aarhus.rm.dk lat: 56.15674 lon: 10.21076 facility: Regional Hospital Silkeborg, Central Jutland Hospital status: RECRUITING city: Silkeborg zip: 8600 country: Denmark name: Katrine B Gørlitz, MD role: CONTACT phone: +45 24210787 email: KAGOER@rm.dk name: Klavs W Hansen, Professor role: CONTACT phone: +45 78417847 email: klavhans@rm.dk lat: 56.1697 lon: 9.54508 hasResults: False

 nctId: NCT06311006 id: K170103J id: 2019-A02579-48 type: OTHER domain: ANSM briefTitle: Safety Registry of a Fecal Microbiota Transplant Cohort acronym: COSMIC-FMT overallStatus: RECRUITING date: 2021-01-04 date: 2029-01-04 date: 2029-01-04 date: 2024-03-15 date: 2024-03-15 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Clostridium difficile infection (CDI) is a major cause of infectious diarrhea and the most important cause of nosocomial diarrhea. Recurrent forms are a major problem with this infection. The use of fecal microbiota transplantation (FMT), FMT appears in the most recent European and North American recommendations.

There is no cohort or multicenter registry in France prospectively collecting FMTs, the methods used, their efficacy and side effects. Likewise, there is no prospective collection focused on the cohort of stool donors. A large national cohort of patients who have undergone FMT as part of routine care as well as donors, is essential for evaluating the safety of FMT. conditions: Clostridium Difficile Infections studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 305 type: ESTIMATED measure: Proportion of hospitalizations attributable to FMT measure: Proportion of Clostridium difficile relapses measure: Proportion of relapse measure: Proportion of reinfections measure: Efficacy of FMT in CDI (defined as free from relapse) at 10 weeks and 3 years according to clinical characteristics of donors measure: Efficacy of FMT in CDI (defined as free from relapse) at 10 weeks and 3 years according to clinical characteristics of patients measure: Efficacy of FMT in CDI (defined as free from relapse) at 10 weeks and 3 years according to the method of preparation and administration of fecal preparation measure: Evolution of transit (i.e. number of stools per day and their consistency) and mean BMI in patients Correlation between the evolution of transit and the BMI of the donor and the patient. measure: Patient status (absence of recurrence or relapse or re-infection) according to the composition of the microbiota (by sequencing or metabolomic method or culture) of the donors. measure: Composition of the patient's microbiota before FMT and at week 10 and composition of the donor's microbiota (by sequencing or metabolomic method or culture) of the raw stool and the preparation to be administered to the patient. measure: adverse event rate measure: Metabolomic, immunological analysis (phenotype of peripheral blood immune cells) of the donor and the patient before and after FMT (at W10). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gastroenterology Department of Saint Antoine Hospital status: RECRUITING city: Paris zip: 75012 country: France name: Harry SOKOL, MD, PhD role: CONTACT phone: 0033 1 49 28 31 62 phoneExt: +33 email: harry.sokol@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06310993 id: STH22549 briefTitle: Exercise to Boost Immunity in Advanced Cancer acronym: BICEP overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-03-01 date: 2026-03-01 date: 2024-03-15 date: 2024-03-15 name: Sheffield Teaching Hospitals NHS Foundation Trust class: OTHER name: University of Sheffield name: Sheffield Hallam University briefSummary: The trial is a prospective feasibility trial conducted in Sheffield. Recruitment will include twenty patients receiving first line palliative immunotherapy for advanced, unresectable or metastatic mesothelioma and patients receiving first line systemic anti-cancer treatment for pancreatic cancer. Patients will attend the AWRC for a supervised exercise session once a week to include aerobic exercise along with an unsupervised weekly exercise session for 3 months. Blood samples will be collected at baseline and then monthly for 3 months, pre and post the supervised exercise session. Cytokine, myokine and immune cell concentration will be analysed using cytokine bead-based multiplex immune assays and RNA-seq to full profile changes in gene and protein expression conditions: Mesothelioma; Lung conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Exercise measure: Primary Outcome Measure measure: Secondary outcome 1 measure: Secondary Outcome 2 measure: Secondary Outcome 3 measure: Secondary Outcome 4 measure: Secondary Outcome 5 measure: Secondary Outcome 6 measure: Secondary Outcome 7 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Research Centre at Weston Park Hospital city: Sheffield state: England zip: S1O 2SJ country: United Kingdom lat: 53.38297 lon: -1.4659 facility: Sheffield Hallam University city: Sheffield state: South Yorkshire zip: S10 2BP country: United Kingdom lat: 53.38297 lon: -1.4659 hasResults: False

 nctId: NCT06310980 id: SMARTPEN briefTitle: Pilot Study to Verify Effect of Smartpen Coordinated With Glucose Sensor. acronym: SMARTPEN overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-07-01 date: 2025-04-01 date: 2024-03-15 date: 2024-03-15 name: Giulio Frontino class: OTHER briefSummary: The Aim of this interventional study in to assess the effect of the use of a smartpen connected by an APP to continuous glucose sensors in a cohort of diabetic adolescents in not good metabolic control.

Primary endpoint: time in range Secondary endpoints: other glucometrics, Hba1c, treatment satisfaction. conditions: Diabetes Mellitus, Type 1 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 34 type: ESTIMATED name: smartpen measure: Time in range measure: time below range measure: time above range measure: coefficient of variation (CV) measure: HbA1c measure: ITSRQ measure: DIDS sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06310967 id: IG3018-23-02-01 briefTitle: A Dose Escalation Study of IG3018 in Subjects With Hyperuricemia With or Without Chronic Kidney Disease overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-06 date: 2025-06 date: 2024-03-15 date: 2024-03-15 name: Intelligem Therapeutics Australia Pty Ltd. class: INDUSTRY briefSummary: This is a phase I/II clinical study to evaluate the safety, tolerability, PK, and efficacy of IG3018 tablet in hyperuricemia (HUA) subjects with or without CKD. conditions: Hyperuricemia conditions: Hypouricemia, Renal studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Part 1 is a randomized, double-blind, placebo-controlled study where the doses of the study drug are escalated in a predesigned manner in 3 cohorts.

Initiation Dose shall be at 0.25 g tablets (Cohort A) and doses are escalated to 0.5 g (Cohort B) and then to 1.0 g (Cohort C) in a planned manner. Each cohort will have 10 eligible patients. Randomization will be performed in Part 1 and as per the randomization code, 8 subjects will receive the active study drug (IG3018) and 2 shall receive placebo in each dose cohort. A total of 30 subjects are planned to be enrolled.

Part 2 is an open-label proof of concept study involving hyperuricemia subjects with advanced predialysis CKD (Stage 3A, Stage 3B and Stage 4), and treated with two doses \[0.5 g BID IG3018 (Cohort D) and 1.0 g BID IG3018 (Cohort E)\] . At least 5 to 8 hyperuricemia subjects with advanced CKD will be enrolled in each dose and will receive the determined study dose of IG3018 twice daily (BID) for 4 weeks. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Part 1 is a randomized, double-blind, placebo-controlled study. For each dose cohort in Part 1, the Sponsor, subjects and other personnel involved with the conduct of the study will be blinded to the study products.

Part 2 is an open-label proof of concept study. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 46 type: ESTIMATED name: IG3018 name: Placebo matching IG3018 measure: Safety Assessments (Part 1 and Part 2) measure: The proportions of change from baseline in serum uric acid to normal level (≤ 0.36 mmol/L) (Part 1 and Part 2) measure: The proportions of change from baseline in serum uric acid to ≤ 0.30 mmol/L and ≤ 0.24 mmol/L respectively (Part 1 and Part 2) measure: The actual change of serum uric acid (Part 1 and Part 2) measure: The percentage change of serum uric acid (Part 1 and Part 2) measure: Gouty Attacks (Part 1 and Part 2) measure: Urinary Albumin/Creatinine Ration (U-ACR) (Part 2 only) measure: Ae of IG3018 (Part 1 only) measure: Cmax of IG3018 (Part 1 only) measure: Tmax of IG3018 (Part 1 only) measure: T1/2 of IG3018 (Part 1 only) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06310954 id: 2022-KY-012 briefTitle: Ketogenic Diet in Pediatric Intractable Epilepsy overallStatus: RECRUITING date: 2022-08-11 date: 2024-04-30 date: 2024-04-30 date: 2024-03-15 date: 2024-03-15 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: This study aims to evaluate the efficacy of a ketogenic diet in treating pediatric intractable epilepsy and to explore its relationship with changes in inflammatory markers. The investigators plan to recruit 59 participants with intractable epilepsy, 39 of whom will receive a combination of ketogenic diet and conventional antiepileptic drugs, while 20 will receive only conventional drugs. The study will assess the impact of the ketogenic diet on epilepsy control and inflammatory markers, hoping to discover new treatment strategies. conditions: Epilepsy in Children conditions: Epilepsy Intractable studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 59 type: ESTIMATED name: Early ketogenic diet combined with conventional pharmacotherapy. name: Common diet combined with conventional pharmacotherapy measure: Epilepsy Control Response Rate measure: Inflammatory Marker Levels sex: ALL minimumAge: 6 Months maximumAge: 12 Years stdAges: CHILD facility: Sun Yat Sen Memorial Hospital， Sun Yat Sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Dongfang Li role: CONTACT phone: +8615521284993 email: ldf201310@163.com name: Dongfang Li role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06310941 id: ABSENTA id: Pending type: OTHER domain: Ceim HCSC (ERB of Hospital Clinico San Carlos)) briefTitle: Mechanical Insufflation-exsufflation and Hypertonic Saline in Nosocomial Bacterial Respiratory Tract Infection acronym: ABSENTA overallStatus: NOT_YET_RECRUITING date: 2024-12-01 date: 2026-10-30 date: 2026-12-30 date: 2024-03-15 date: 2024-03-15 name: Hospital San Carlos, Madrid class: OTHER briefSummary: Randomized open label clinical trial to evaluate IEM and HS as concomitant therapy for respiratory tract infection in patients under artificial ventilation in the ICU.

Lung infection is a serious complication that may occur during hospital stay and may need artificial respiration or even develop during artificial ventilation for other causes.

Current specific treatment consists of intravenous antibiotics. The current study evaluated whether aspiration and drainage of infected sputum helps curing this severe complication and whether nebulized HS has additional benefits, like eradicating bacteria or reducing inflammation. conditions: Nosocomial Infection conditions: Nosocomial Pneumonia conditions: Tracheobronchitis conditions: Mechanical Ventilation Complication conditions: Endotracheal Intubation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized, open label primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Mechanical insufflation-exsufflation name: Standard of Care name: Hypertonic saline with hyaluronic acid measure: Median SOFA score increase >2 points on day 4 measure: Median respiratory support-free days increase at day 28 measure: Percentage of subjects surviving/dying day 28 measure: Subjects with bacterial eradication in respiratory samples at day 4 after randomization measure: Subjects with bacterial eradication in respiratory samples at end of systemic antibiotic therapy measure: Median Length of ICU stay measure: Median antibiotic-free days at 28 days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06310928 id: SBU-201001077-2022 briefTitle: The Effect of Thermal Blanket After Peripheral Artery Surgery overallStatus: RECRUITING date: 2022-05-20 date: 2024-03 date: 2024-03 date: 2024-03-15 date: 2024-03-15 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: Peripheral arterial disease is one of the most common clinical conditions associated with cardiovascular morbidity and increased mortality, requiring exercise, antiaggregant and surgical revascularization therapy. As in peripheral arterial surgery, postoperative hypothermia is common in patients who have undergone surgical intervention and the duration of surgery is longer than 30 minutes due to the low temperature of the surgical environment or the suppression of the thermoregulation center by anesthetics and sedatives. With hypothermia, heat loss increases,peripheral vasoconstriction with activation of the sympathetic system, impaired perfusion at the surgical wound site, hypoxemia, coagulopathy, bleeding, postoperative pain, deterioration of thermal comfort, deterioration of patient comfort and prolonged hospital stay are reported. Many heating methods are used to achieve and maintain normal body temperature in the postoperative period, to prevent complications caused by hypothermia.Aluminum-coated thermal blankets are especially preferred. In this way, heat preservation, peripheral vasodilation and perfusion with the effect of temperature, reduction of muscle spasm with increased endorphin release, less pain, and increased comfort of the patient are provided. The thermal blanket is an easy-to-apply material that does not require any tools or electricity for its effectiveness and can come into direct contact with the patient's skin. It provides thermal insulation with its ability to reflect thermal radiation. Peripheral vasodilation and decreased peripheral vascular resistance have been observed with thermal therapy provided by thermal blankets. It is known that thermal blanket methods are used to warm patients in practice. However, the lack of a literature study on the regional effect of these applications on the patient has been noticed. For this purpose, in this study, the regional efficacy of thermal blankets on the patient was evaluated in order to reduce the narrowed arterial lumen and increased peripheral vascular resistance in peripheral arterial diseases and to prevent the vasoconstrictive effect of hypothermia on peripheral vessels. It was predicted that these blankets would maintain heat, increase tissue perfusion with peripheral vasodilation effect, facilitate circulation, reduce pain and facilitate mobilization.In line with this aim, the objectives are;

* To increase peripheral tissue perfusion and decrease neurovascular damage by using thermal blankets for heating after peripheral arterial surgery.
* To reduce the degree of surgical wound site and ischemic pain by using thermal blankets for warming after peripheral arterial surgery.
* To increase the patient's postoperative mobility and mobilization by using thermal blankets in peripheral artery postoperative warming.
* To contribute to the control of pain, neurovascular follow-up and reduction of damage and mobilization, which are the main nursing goals after surgery.
* To increase the comfort of the patient by utilizing the heat insulation and flexible effect of thermal blankets, thus providing an easy-to-apply, effective care in terms of nursing and increasing the quality of health care service.

Research Design This study is a randomized controlled trial to determine the effect of a thermal blanket applied to the area after peripheral arterial surgery on the patient's circulation, pain and mobilization. conditions: Peripheral Arterial Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a single center randomized controlled clinical trial.The sample consisted of a total of 60 patients who would undergo interventional peripheral arterial surgery, met the study criteria and agreed to participate in this study. They will be divided into two groups as 30 experimental group and 30 control group by randomization method. primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Thermal Blanket measure: The Effect of Thermal Blanket Applied to the Area After Peripheral Artery Surgery on Circulation measure: The Effect of Thermal Blanket Applied to the Area After Peripheral Artery Surgery on Pain measure: The Effect of Thermal Blanket Applied to the Area After Peripheral Artery Surgery on Mobilization sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sağlık Bilimleri University status: RECRUITING city: Istanbul state: Uskudar zip: 34674 country: Turkey name: BIRGUL AYDOGAN, RN role: CONTACT phone: +905336337651 email: 201001077@ogrenci.sbu.edu.tr name: SONAY GÖKTAŞ, PROF.DR. role: CONTACT phone: +905324567776 email: sonay.goktas@sbu.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06310915 id: CROC202310 briefTitle: Oral Chemotherapeutic Drugs Were Analyzed in Patients With Driver Gene Negative Locally Advanced/Advanced Non-small Cell Lung Cancer With PS Score 2 A Prospective, Single-arm, Multicenter, Observational Study on the Efficacy and Safety of Radiochemotherapy Combined With PD-1 Inhibitor overallStatus: RECRUITING date: 2023-03-17 date: 2025-03 date: 2025-05 date: 2024-03-15 date: 2024-03-15 name: Guangzhou Institute of Respiratory Disease class: OTHER briefSummary: Oral chemotherapeutic drugs were analyzed in patients with driver gene negative locally advanced/advanced non-small cell lung cancer with PS score 2 A prospective, single-arm, multicenter, observational study on the efficacy and safety of radiochemotherapy combined with PD-1 inhibitor. conditions: Non-small Cell Lung Cancer Stage IIIB/IV studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Navelbine oral,Pembrolizumab measure: Progression-free survival time sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Guangzhou Medical University status: RECRUITING city: Guangdong state: Guangzhou zip: 510000 country: China name: zhou chegnzhi, doctor role: CONTACT phone: 13560351186 email: doctorzcz@163.com hasResults: False

 nctId: NCT06310902 id: 2024KY022 briefTitle: Single-cell Sequencing Analysis of Resectable/Borderline Resectable Pancreatic Cancer Patients overallStatus: RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2026-09-01 date: 2024-03-15 date: 2024-03-15 name: Fujian Medical University Union Hospital class: OTHER briefSummary: Preoperative neoadjuvant chemotherapy is widely used in treating patients with borderline resectable pancreatic cancer (BRPC). However, there are limitations in this field. Treatment strategies and definitions for BRPC patients differ, and the efficacy and prognosis of neoadjuvant chemotherapy vary greatly.This study aims to utilize single-cell sequencing technology to investigate in-depth the composition and interactions of the tumor microenvironment in patients from the surgical-only group and the preoperative neoadjuvant chemotherapy group. conditions: Pancreatic Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Single-cell Sequencing Analysis measure: Bioinformatics analysis of single-cell sequencing results sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Medical University Union Hospital status: RECRUITING city: Fuzhou state: Fujian zip: 350001 country: China name: Yu Pan, M.D role: CONTACT phone: +86 18900316399 email: yupan199002@163.com lat: 26.06139 lon: 119.30611 hasResults: False

 nctId: NCT06310889 id: EPIC-Baseline-Survey briefTitle: Evaluation of Palliative Care Co-treatment by Attending Physicians and Nurses: an Online Survey as Part of the Project acronym: EPIC-BS overallStatus: WITHDRAWN date: 2024-04-01 date: 2024-06-30 date: 2024-06-30 date: 2024-03-15 date: 2024-03-18 name: Charite University, Berlin, Germany class: OTHER name: European Commission name: National and Kapodistrian University of Athens name: King's College Hospital NHS Trust briefSummary: The subject of the study is an online survey of doctors and nurses who provide (intensive) medical care to patients. conditions: Palliative Medicine studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 0 type: ACTUAL measure: Barriers 1 measure: Barriers 2 measure: Measures 1 measure: Measures 2 measure: Resources 1 measure: Resources 2 sex: ALL minimumAge: 18 Years maximumAge: 67 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06310876 id: M24-852 briefTitle: A Thorough QT Study of ABBV-CLS-7262 in Healthy Subjects overallStatus: RECRUITING date: 2024-03-14 date: 2024-06 date: 2024-07 date: 2024-03-15 date: 2024-03-29 name: Calico Life Sciences LLC class: INDUSTRY name: AbbVie briefSummary: This is a randomized, blinded, placebo and active-controlled, 4-period, crossover design thorough QT/QTc (TQT) study to evaluate the effect of ABBV-CLS-7262 on cardiac repolarization in healthy adult subjects. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 72 type: ESTIMATED name: ABBV-CLS-7262 name: ABBV-CLS-7262 name: Placebo name: Moxifloxacin 400mg measure: To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects measure: To evaluate the effects of ABBV-CLS-7262 on change in electrocardiogram (ECG) parameters measure: To evaluate the sensitivity of QTc measurement using moxifloxacin measure: To evaluate the effect of ABBV-CLS-7262 on T-wave morphology sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: AbbVie Clinical Pharmacology Research Unit (ACPRU) status: RECRUITING city: Grayslake state: Illinois zip: 60030 country: United States lat: 42.34447 lon: -88.04175 hasResults: False

 nctId: NCT06310863 id: EXOCOBIO-NASAL-01 briefTitle: Pivotal Study to Evaluate the Efficacy and Safety of Injection With LASBEAU Strong in Correction of Nasolabial Folds overallStatus: COMPLETED date: 2019-10-07 date: 2020-11-24 date: 2020-11-24 date: 2024-03-15 date: 2024-03-15 name: Asan Medical Center class: OTHER briefSummary: Background: Nonsurgical injectable treatments have become popular for aesthetic purposes. In recent years, cross-linked hyaluronic acid (HA) fillers containing lidocaine have been used to correct the nasolabial folds.

Aim: The aim of this study was to demonstrate the efficacy and safety of a new HA filler (LASBEAU Strong) (24 mg/mL) compared with a conventional HA filler (Restylane Lyft) for the restoration of nasolabial folds.

Patients/methods: A total of 72 subjects were enrolled and randomized to receive injections of the new HA filler (test group) or the conventional HA filler (control group) on the left or right side of the face. The mean value difference in the Wrinkle Severity Rating Scale (WSRS) scores at week 24 evaluated primary efficacy. The WSRS and the Global Aesthetic Improvement Scale (GAIS) at weeks 8, 16, 24, and 48 evaluated secondary efficacy. Adverse events, laboratory tests, and a check of vital signs at every visit assessed safety. conditions: Dermal Fillers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, Matched pairs, Active controlled primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 72 type: ACTUAL name: LASBEAU Strong or Restylane Lyft injection as hyaluronic acid fillers measure: Differences in the mean value of the Wrinkle Severity Rating Scale (WSRS) between the test group and the control group measure: The mean value differences in the WSRS scores between the test group and the control group measure: Differences in GAIS mean values between test and control groups measure: Percentage of subjects with WSRS score improvement of at least 1 point sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Asan mediccal center city: Seoul state: Songpa-gu zip: 05505 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06310850 id: KEAH-238 briefTitle: The Effect of Preprocedural Subanesthetic Ketamine on Pain and Anxiety overallStatus: COMPLETED date: 2013-06-01 date: 2023-01-01 date: 2023-06-01 date: 2024-03-15 date: 2024-03-15 name: Ankara Ataturk Sanatorium Training and Research Hospital class: OTHER_GOV briefSummary: The thoracic epidural catheterization (TEC) can be both uncomfortable and fearful for patients when done awake with the thought that the procedure may be painful. The aim of this study was to assess the effect of subanesthetic intravenous ketamine administration on pain and anxiety during the TEC procedure. conditions: Epidural Catheterization conditions: Thoracic conditions: Procedural Pain studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study was designed as a randomized, prospective study primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ACTUAL name: Ketamine name: Placebo measure: Visual analog scale (VAS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Atatürk Sanatorium Training and Research Hospital city: Ankara state: Keçiören zip: 06290 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06310837 id: 2023KYPJ300 briefTitle: Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis overallStatus: NOT_YET_RECRUITING date: 2024-03-27 date: 2024-08-27 date: 2025-06-30 date: 2024-03-15 date: 2024-03-15 name: Zhongshan Ophthalmic Center, Sun Yat-sen University class: OTHER name: The Eye Hospital of Wenzhou Medical University name: The First Affiliated Hospital of Soochow University name: Shandong Eye Hospital briefSummary: This is a multi-center, prospective, randomized controlled non-inferior clinical study. A total of 120 subjects with non-infectious intermediate, posterior, or panuveitis were enrolled in Zhongshan Ophthalmic Center and three other centers. They were randomly assigned to the experimental group and the control group according to ( 1 : 1 ). We hypothesized that adalimumab biosimilars combined with immunosuppressive agents in the treatment of non-infectious uveitis is not inferior to glucocorticoids combined with immunosuppressive agents, and there are no additional adverse events and safety issues. conditions: Uveitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Adalimumab Biosimilars Injection name: Corticosteroid name: Immunosuppressive Agents measure: Change of ETDRS letter count for BCVA at week 24 from baseline measure: Proportion of patients with weight gain at week 24 from baseline measure: Time of treatment failures measure: Number of treatment failures measure: Change of Visual Functioning Questionnaire- 25 (VFQ-25) composite score from baseline measure: Change of anterior chamber inflammation at week 24 from baseline measure: Change of vitreous opacity at week 24 from baseline measure: Change of the retinal and choroidal inflammation at week 24 from baseline measure: Change of the thickness of retina and choroid in macular area at week 24 from baseline measure: Occurrence of skin abnormalities at the end of study measure: Occurrence of hypertension at the end of study measure: Occurrence of hyperglycemia at the end of study measure: Occurrence of active tuberculosis infection at the end of study sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Ophthalmic Center city: Guangzhou state: Guangdong zip: 510060 country: China name: Wei Chi role: CONTACT phone: 13710616456 email: chiwei@mail.sysu.edu.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06310824 id: MAB-22-101 briefTitle: Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia® overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-07 date: 2025-07 date: 2024-03-15 date: 2024-03-18 name: Xentria, Inc. class: INDUSTRY briefSummary: A Randomized, Double-blind, Controlled, Parallel-group, Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia® conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 225 type: ESTIMATED name: MAB-22 name: EU-Prolia® name: US-Prolia® measure: Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-∞) measure: Maximum observed serum concentration (Cmax) measure: Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last) measure: Area under the concentration-time curve measure: Area under the concentration-time curve sex: MALE minimumAge: 25 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06310811 id: BHCT-RD06-04-01 briefTitle: Anti-CD19 CAR-T Cell Therapy in Participants With Moderate to Severe Active Systemic Lupus Erythematosus overallStatus: RECRUITING date: 2024-03-07 date: 2025-03-01 date: 2027-03-01 date: 2024-03-15 date: 2024-03-15 name: Wuhan Union Hospital, China class: OTHER briefSummary: This is an open, Phase I, investigator-initiated study (IIT) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with moderate or severe active SLE.

This study will explore the safety of escalating doses of RD06-04 by presetting two dose levels (DL), with 3 to 6 patients enrolled in each dose level. After safety conclusions are reached in each group, the investigator can select the corresponding dose group to expand cases based on treatment response, but the total number of cases will not exceed 12.

This study will enroll patients in a 3+3 design with two DLS: 1×105 CAR+T cells /kg for DL1 and 5×105 CAR+T cells /kg for DL2.

Dose increment Refer to the 3+3 dose increment principle. Three subjects are expected to be enrolled in each dose group.

1. Dose increment should start from the minimum dose, and it is not possible to conduct an incremental study of 2 or more dose groups at the same time.
2. If 1 case of DLT occurs in each dose group, the dose level will be extended to 6 subjects. If 6 subjects at this dose level ≥2 subjects develop DLT, the dose level exceeds the MTD. The previous lower dose level will be extended to 6 subjects, and if 6 subjects have already been enrolled in the previous lower dose level, and only ≤1 of these 6 subjects develop DLT, this lower dose level will be considered MTD.
3. If DLT occurred in ≥2 subjects in the highest dose group, the researcher could select a dose between the high dose group and the medium dose group according to the specific situation and perform MTD evaluation.
4. If the dose increase to the highest dose group still does not reach DLT, researchers can explore the safety and efficacy of higher doses according to specific circumstances.

Case expansion:

After the completion of DLT evaluation in all dose groups, the investigators could select the corresponding dose group of extended cases according to the treatment response, but the total number of cases should not exceed 12 (extended cases were not evaluated by DLT). conditions: Safety conditions: Effective studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All patients will be treated with RD06-04 cell injections in a single group primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: RD06-04 Cells injection measure: Incidence of dose-limiting toxicity (DLT) measure: The incidence of treatment-based adverse events (TEAEs) and the incidence of serious adverse events (SAEs). sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wuhan Union status: RECRUITING city: Wuhan state: Hubei zip: 430000 country: China name: Heng Mei, Chief physician role: CONTACT phone: 13886160811 email: hmei@hust.edu.cn lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06310798 id: Dnr. 2020-04603 briefTitle: Inter-organizational Health Planning for Older Adults: Public Dental Care and Municipal Care acronym: GAPA overallStatus: NOT_YET_RECRUITING date: 2025-03-01 date: 2025-05-15 date: 2026-03-01 date: 2024-03-15 date: 2024-03-15 name: Vastra Gotaland Region class: OTHER_GOV name: Göteborg University name: Gothia Forum - Center for Clinical Trial name: Chalmers University of Technology briefSummary: Patient participation is key for healthy ageing and essential in health planning and decision-making. Oral health is an important but sometimes neglected part of general health and there is little research on health planning in ordinary home settings where older adults, dental and nursing staff participate. It has been concluded that shared tools, such as common documentation, and working in teams enables person-centered care in ordinary home settings. Therefore, this protocol outlines the design of a randomized controlled trial (RCT) measuring and comparing effect of two models of team based oral health planning with a common tool (digital platform) in ordinary home care settings in Sweden. The overall aim of this project is to evaluate a person-centered inter-professional and inter-organizational model for oral health planning supported by a digital platform to enable healthy ageing.

Following ethics approval, a study design was developed guided by the seven action-steps of the knowledge to action framework. In the sixth action-step, older adults within the existing dental care remuneration program in Sweden will serve as a base for the RCT. From there older adults,dental hygienists (DH) and nursing assistants (NA) will be randomized into test and control groups. The test group (n= 12 DH and 12 NA) will participate in a two-day course, where a three-step person-centered oral health model will be taught. Control group will be 12 DH within dental care remuneration program conducting business as usual (with unknown number of NA, due to present guidelines). In total 360 older adults/patients will be asked to participate. Test group and control group will respectively have 180 patients each, as such, each team (DH + NA) have 15 patients. Primary outcomes include diverse oral health aspects - the Revised Oral Assessment Guide and the Geriatric Oral Health Assessment Index. Secondary outcomes include a retrospective record review, a health economic evaluation, Person Centered care Assessment Tool and Oral Hygiene Ability Index. Additionally, qualitative studies from theoretical perspectives of change and learning based on interviews with key stakeholders will be conducted in both test and control group. conditions: Oral Health conditions: Oral Health Related Quality of Life conditions: Participation conditions: Participation, Patient conditions: Health Planning studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In pairs, DHs within public dental care organization in the West of Sweden will be randomized into test and control groups. Due to geographical concerns, NAs within the same municipal as the test control DHs will be asked to participate. As such, the test-group will consist of 12 DHs and 12 NAs. They will form teams in pairs, and each team will collaborate with 15 older adults each in home settings, who participate in the oral assessments and health planning. The control group will consist of 12 DHs which will perform oral assessments according to dental care remuneration programme - business as usual. It is not mandatory but recommended for NAs to participate in the oral assessments, therefore the number of participating NAs within control group is unknown. In total 360 oral assessments and health planning will be performed within the RCT. primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 360 type: ESTIMATED name: Inter-professional team test measure: Revised oral assessment guide measure: Revised oral assessment guide measure: Revised oral assessment guide measure: Geriatric oral health assessment index measure: Geriatric oral health assessment index measure: Geriatric oral health assessment index measure: Sure of myself; understanding information; risk-benefit ration; encouragement-test measure: Person centered care assessment tool measure: Person centered care assessment tool measure: Retrospective review of records within municipal health care measure: Participants experiences of oral health planning in ordinary home settings measure: Oral hygiene ability index (OHAI) measure: Oral hygiene ability index (OHAI) measure: Health related quality of life instrument measure: Health related quality of life instrument measure: Health related quality of life instrument sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Folktandvården Västra Götaland city: Göteborg state: Västra Götalandsregionen zip: 42139 country: Sweden name: Jessica Persson Kylén, PhD role: CONTACT phone: +46769472654 email: jessica.persson-kylen@hv.se name: Eva-Karin Bergström, PhD role: CONTACT phone: +46733261110 email: eva-karin.bergstrom@vgregion.se name: Åsa Leonhardt, PhD role: PRINCIPAL_INVESTIGATOR lat: 57.70716 lon: 11.96679 hasResults: False

 nctId: NCT06310785 id: TJ-IRB20231191 briefTitle: Esketamine Anesthesia in Thoracic Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-31 date: 2024-08-31 date: 2024-03-15 date: 2024-03-15 name: Hui Xu class: OTHER briefSummary: Esketamine group was induced with esketamine 0.5 mg/kg, propofol 2 mg/kg, and rocuronium bromide 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and esketamine 0.5 mg/kg/h. Anesthesia induction in the opioid group Sufentanil 0.5 ug/kg, propofol 2 mg/kg, rocuronium bromide 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and remifentanil 1 ug/kg/h. conditions: General Anesthesia conditions: Thoracic Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Neither the patients who participated in the trial nor the analysis of the results of the study were aware of the experimental group whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Esketamine name: Sufentanil measure: Dynamic compliance of the ventilator-side lung during 30 minutes of one-lung ventilation during operation measure: Lung compliance during double lung ventilation during operation measure: Compliance of the ventilator-side lung during one-lung ventilation during operation measure: Blood pressure measure: Heart rate measure: Blood gas analysis results measure: Serum inflammatory factor levels measure: cognitive function measure: Postoperative nausea and vomiting measure: Depression and anxiety measure: Postoperative pain sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06310772 id: NSF 2304297 briefTitle: Assessing Comorbidities in Epilepsy Using Eye Movement Recordings acronym: ACER overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-01 date: 2025-03-01 date: 2024-03-15 date: 2024-03-15 name: Eysz, Inc. class: INDUSTRY name: Wake Forest University Health Sciences name: Children's Hospital of Orange County name: University of Colorado, Denver briefSummary: This study wants to make it easier to find kids with a type of epilepsy called childhood absence epilepsy (CAE) who might have problems with ongoing seizures and thinking. Right now, doctors use tests that can be expensive and take a long time. Eysz is developing a system that looks at how kids move their eyes which might help find CAE more quickly and accurately. This study will compare Eysz with the usual tests to see if it can predict seizures and thinking problems in kids with CAE. The goal is to find these problems earlier and help kids do better in school and life. conditions: Childhood Absence Epilepsy conditions: Absence Seizures conditions: Epilepsy Comorbidities studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: Eye Movements to Diagnose CAE measure: Eye Movements to Diagnose Attention challenges sex: ALL minimumAge: 4 Years maximumAge: 12 Years stdAges: CHILD facility: Children's Hospital Orange County city: Orange state: California zip: 92868 country: United States lat: 33.78779 lon: -117.85311 facility: Wake Forest Baptist Health city: Winston-Salem state: North Carolina zip: 27157 country: United States lat: 36.09986 lon: -80.24422 hasResults: False

 nctId: NCT06310759 id: R21088B briefTitle: Prospective Validation Study of High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer acronym: UROSCOUT-1 overallStatus: RECRUITING date: 2024-01-08 date: 2026-12-31 date: 2029-12-31 date: 2024-03-15 date: 2024-03-15 name: Tampere University Hospital class: OTHER name: Tampere University briefSummary: Urothelial cancers of the bladder and upper urinary tract account for over 200,000 deaths and 600,000 diagnoses annually worldwide. The most common presenting symptom is hematuria (blood in urine), triggering a cascade of tests, including an invasive examination of the bladder using a flexible scope (cystoscopy). Millions of cystoscopies are performed every year worldwide for patients presenting with hematuria, but only 10% result in a cancer diagnosis. The UROSCOUT-1 trial is a prospective multicenter observational study that explores the potential of urine tumor DNA (utDNA) testing to replace a significant portion of cystoscopies in the diagnostic setting for hematuria or other reasons to rule out urothelial cancer. The goal is to enhance patient quality of life, reduce healthcare costs, and address increased workloads in urology centers. Sample collection will be conducted by mail, and the samples will be analyzed in a blinded manner, without knowledge of which patients are diagnosed with cancer. Random subsampling will be applied to cancer-negative patients to achieve an approximate 1:1 ratio between cancer-positive and -negative patients. conditions: Urothelial Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED measure: Sensitivity and specificity of urine tumor DNA (utDNA) test for urothelial cancer detection measure: Sensitivity and specificity of cystoscopy for urothelial cancer detection measure: Sensitivity and specificity of urine cytology for urothelial cancer detection measure: Time to diagnosis of urothelial cancer in patients with a positive utDNA test but negative cystoscopy measure: Adverse event rate for cystoscopy measure: Technical success rate of utDNA test measure: Estimate of diagnostic cystoscopies avoided measure: Specificity of high-stringency utDNA threshold measure: Characteristics of urothelial cancers that were not detected by the utDNA test measure: Concordance between utDNA and urine cytology results sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vancouver Prostate Centre status: NOT_YET_RECRUITING city: Vancouver state: British Columbia country: Canada name: Peter Black role: CONTACT name: Peter Black role: PRINCIPAL_INVESTIGATOR lat: 49.24966 lon: -123.11934 facility: Helsinki University Hospital status: NOT_YET_RECRUITING city: Helsinki country: Finland name: Riikka Järvinen role: CONTACT name: Tuomas Jalanko role: CONTACT lat: 60.16952 lon: 24.93545 facility: Tampere University Hospital and Tampere University status: RECRUITING city: Tampere country: Finland name: Jussi Nikkola role: CONTACT name: Thea Veitonmäki role: CONTACT name: Jussi Nikkola role: PRINCIPAL_INVESTIGATOR name: Matti Annala role: PRINCIPAL_INVESTIGATOR lat: 61.49911 lon: 23.78712 facility: Turku University Hospital status: NOT_YET_RECRUITING city: Turku country: Finland name: Peter Boström role: CONTACT name: Otto Ettala role: CONTACT lat: 60.45148 lon: 22.26869 hasResults: False

 nctId: NCT06310746 id: HLX6018-FIH101 briefTitle: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Phase I Clinical Study to Assess the Safety, Pharmacokinetics, and Immunogenicity of HLX6018 in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-12-30 date: 2026-12-30 date: 2024-03-15 date: 2024-04-04 name: Shanghai Henlius Biotech class: INDUSTRY briefSummary: The purpose of this study is to investigate the safety, PK, and immunogenicity of a single intravenous administration of HLX6018 in healthy subjects, based on the preliminary efficacy and safety established through in vitro and in vivo experiments.

This is a randomized, double-blind, placebo-controlled study with single dose escalation design to assess the safety, PK, and immunogenicity of HLX6018 in healthy subjects. It is planned to enroll 8-10 subjects in each of seven dose groups (0.25 mg/kg, 1.0 mg/kg, 4.0 mg/kg, 12 mg/kg, 25 mg/kg, 50 mg/kg, and 70 mg/kg). This is the first-in-human study of the investigational product. conditions: IPF studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 66 type: ESTIMATED name: GARP/TGF-β1 monoclonal antibody name: Placebo measure: The number of subjects experiencing adverse events (AEs) and serious adverse events (SAEs) measure: AUC0-inf measure: Cmax measure: Tmax measure: T1/2 measure: CL measure: λz sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06310733 id: REC 66-517-1-1 briefTitle: The Effects of Probiotics, Lactobacillus GG, in the Treatment of Abdominal Pain in Children With Functional Abdominal Pain Disorders overallStatus: RECRUITING date: 2024-03-21 date: 2025-12-31 date: 2026-02-20 date: 2024-03-15 date: 2024-03-18 name: Prince of Songkla University class: OTHER briefSummary: Recurrent or chronic abdominal pain is one of the common gastrointestinal problems in children. While most children do not have organic origins (so called functional abdominal pain disorders; FAPDs), the symptoms can nevertheless be severe enough to impair the patient's quality of life, growth, and development. To help rule out organic disorders and diagnose this condition, some individuals underwent multiple invasive and costly studies.

Generally, the diagnosis of FAPDs is based on clinical symptoms and criteria, it can be divided into irritable bowel syndrome (IBS), abdominal migraine, functional abdominal pain (FAP) and functional dyspepsia (FD). Approximately 14% of children globally, between the ages of 4 and 18, experience functional abdominal pain issues8. In Thailand, the prevalence of FAPDs among adolescents (mean age of 16 years) was 5.3%, functional dyspepsia and irritable bowel syndrome were found to be the most prevalent subtypes.

The pathogenesis of FAPDs is believed to result from disruptions in the microbiota-gut-brain axis, which may happen early in life or throughout. Hence, several studies, specifically in western countries, reported the role of probiotics, specifically Lactobacillus rhamnosus GG (LGG), in modulating abdominal symptoms in children with FAPDs.

It is widely known that the diversity of gut microbiota depends on multiple factors including ethnicity, mode of delivery, dietary and environmental factors. However, the studies on the use of probiotics in pediatric patients with FAPDs have been mainly conducted in western countries. Since there are limited studies on the effectiveness of probiotics in Asian children with FAPDs, the investigators aim to evaluate the effects of probiotics, LGG, in the treatment of children who suffered from FAPDs.

The secondary objectives are to measure daily pain score in children with and without FAPDs, to evaluate and compare the diversity of fecal microbiota in children with FAPDs and those without FAPDs, and to compare the diversity of fecal microbiota between children with FAPDs who took probiotics and those who did not. conditions: Functional Abdominal Pain Syndrome studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: LGG name: Placebo measure: The response rate of 4 week-probiotics (LGG) on the severity of abdominal pain (number of episodes or the intensity of pain), compared to the conventional treatment, in children who suffered from FAPDs measure: The response rate of 4 week-probiotics (LGG) on the severity of abdominal pain (number of episodes or the intensity of pain), compared to the conventional treatment, in children who suffered from FAPDs measure: The response rate of 4 week-probiotics (LGG) on the severity of abdominal pain (number of episodes or the intensity of pain), compared to the conventional treatment, in children who suffered from FAPDs measure: To measure daily pain score in children with and without FAPDs measure: To measure daily pain score in children with and without FAPDs measure: To measure daily pain score in children with and without FAPDs measure: To compare the diversity of fecal microbiota in children with FAPDs who took probiotics and those who did not sex: ALL minimumAge: 6 Years maximumAge: 15 Years stdAges: CHILD facility: Atchariya Chanpong status: RECRUITING city: Songkhla country: Thailand name: Atchariya Chanpong, M.D, Ph.D. role: CONTACT phone: +6674451250 email: atchariya.c@psu.ac.th lat: 7.19882 lon: 100.5951 hasResults: False

 nctId: NCT06310720 id: 23-10026618 briefTitle: Postpartum Video Education in High Risk Populations overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-15 date: 2024-03-15 name: Weill Medical College of Cornell University class: OTHER briefSummary: This is a prospective, single-center, randomized control study to determine if video education at the time of postpartum discharge improves patient knowledge on the warning signs for the top three causes of severe maternal morbidity (infection, hemorrhage, and blood pressure disorders) in the first seven days following delivery for self-identified, Black, Latinx, other with two or more self-identified races, Medicaid, and/or uninsured postpartum individuals. Participants will be randomized to written discharge education + video education (intervention) vs standard discharge education (control). They will complete a baseline questionnaire and a post-discharge education questionnaire during their postpartum stay to assess for knowledge improvement. The investigators hypothesize that video education will improve patient's knowledge of severe maternal morbidity warning signs. conditions: Postpartum Hemorrhage conditions: Postpartum Depression conditions: Postpartum Sepsis conditions: Postpartum Preeclampsia conditions: Patient Empowerment conditions: Patient Education conditions: Postpartum Care studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 150 type: ESTIMATED name: Video Education measure: Change in baseline and post-education questionnaire score measure: Change in post-education and post-discharge questionnaire score measure: Number of participants who attended 6 week postpartum visit measure: Healthcare utilization: Number of clinic visits measure: Healthcare utilization: Number of phone calls measure: Healthcare utilization: Number of urgent care/emergency room visits measure: Mean difference in patient satisfaction rating sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alexandra Cohen Hospital for Women and Newborns city: New York state: New York zip: 10065 country: United States name: Heather Lipkind, MD, MSce role: CONTACT phone: 212-746-3045 email: hlipkind@weill.cornell.edu name: Heather Lipkind, MD, MSce role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06310707 id: EU RCT: ePatch vs 24h Holter id: 2022-A02338-35 type: OTHER domain: ANSM, French competent authority id: EA4/071/23 type: OTHER domain: German Ethics Committee_Charité Universitätsmedizin Berlin briefTitle: Arrhythmia Identification in Syncope Patients: ePatch® Versus 24h Holter overallStatus: RECRUITING date: 2023-11-09 date: 2025-04 date: 2025-08 date: 2024-03-15 date: 2024-03-15 name: Philips Clinical & Medical Affairs Global class: INDUSTRY briefSummary: This study is a Multi-center, prospective, randomized, unblinded, two-arm study to assess if 7-days of cardiac monitoring using the ePatch Holter results in identification of more clinically actionable arrythmia for patients with symptoms of syncope than standard 24 hour Holter monitoring. conditions: Arrythmia conditions: Syncope studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multi-center, prospective, randomized, unblinded, two-arm study, to include approximately 128 subjects treated with the ePatch Extended Wear Holter (worn for 7 days) and approximately 128 subjects treated with a Standard Wear Holter (worn for 24 hours). Randomization will be balanced for gender. primaryPurpose: DIAGNOSTIC masking: NONE count: 128 type: ESTIMATED name: ePatch ® Extended Wear Holter (EWH) measure: Diagnostic yield (frequency) of clinically actionable arrythmia measure: Number of Atrial Fibrillation (AF) diagnoses > 30 seconds measure: Occurrence of symptomatic events measure: Number of Clinically actionable arrhythmia measure: Patient Quality of Life as measured by EQ-5D-5L measure: Patient Quality of Life as measured by Patient Experience Survey measure: Cost related to cardiac monitoring measure: Time Holter is worn/ removed sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospices Civils de Lyon - Hôpital Cardiologique Louis Pradel status: RECRUITING city: Bron zip: 69677 Cedex country: France name: Philippe Chevalier, MD PhD role: CONTACT phone: +33.472.357.027 email: philippe.chevalier@chu-lyon.fr name: Philippe Chevalier, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 45.73333 lon: 4.91667 facility: Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin Franklin status: NOT_YET_RECRUITING city: Berlin zip: D-12203 country: Germany name: Tharusan Thevathasan, MD role: CONTACT phone: +49 1577 4407864 email: tharusan.thevathasan@dhzc-charite.de name: Tharusan Thevathasan, MD role: PRINCIPAL_INVESTIGATOR lat: 52.52437 lon: 13.41053 hasResults: False

 nctId: NCT06310694 id: EGE-HEM-SL-01 briefTitle: Additional Circular Dressing Material overallStatus: COMPLETED date: 2023-04-27 date: 2023-09-30 date: 2023-12-30 date: 2024-03-15 date: 2024-03-15 name: Ege University class: OTHER briefSummary: The study was conducted to determine the effect of fixing peripheral intravenous catheter (PIVC) with additional circular dressing material on the duration of PIVC stay and complications related to peripheral intravenous catheterization. In our study, a comparison was made of PIVCs applied to patients in the control (fixation of PIVC with a sterile transparent dressing) and intervention (fixation of PIVC with a sterile transparent dressing and application of an elastane circular dressing on it) groups in a public hospital in Turkey. All-cause PIVC failure was significantly higher in the intervention group (70.2%) compared to the control group (45.5%). It has been determined that fixing the PIVC with additional circular dressing material prolongs the duration of PIVC stay at the site. conditions: Nurse's Role studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In our study, a comparison was made of PIVCs applied to patients in the control (fixation of PIVC with a sterile transparent dressing) and intervention (fixation of PIVC with a sterile transparent dressing and application of an elastane circular dressing on it) groups. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 91 type: ACTUAL name: intervention group (Elastane circular dressing on sterile transparent dressing) measure: Skin Penetration Difficulty Rating Scale measure: Visual Infusion Phlebitis Diagnostic Scale measure: Infiltration Rating Scale measure: Data Collection Form for the Patient Who Had a Peripheral Intravenous Catheter sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Şeyma Turan city: Turgutlu state: Manisa zip: 45400 country: Turkey lat: 38.49533 lon: 27.6997 hasResults: False

 nctId: NCT06310681 id: ETH2223-2528 briefTitle: Pilot Testing of a Co-adapted Group Programme for Parents/Carers of Children With Complex Neurodisability acronym: ENCOMPASS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-10 date: 2024-12 date: 2024-03-15 date: 2024-03-15 name: City, University of London class: OTHER briefSummary: The goal of this pilot feasibility study is to test a co-adapted community-based group programme ("Encompass") with parents/carers of children with complex neurodisability under 5 years of age in East London in the UK.

The main questions it aims to answer are:

* Is it feasible and acceptable to carry out this newly co-adapted programme with two groups of parents/carers of children with complex neurodisability under the age of 5?
* Is it feasible to carry out an evaluation of the above programme, which could then inform a protocol for larger scale evaluation?

The main activities for the parent/carer participants will include:

* Attending ten "Encompass" parent/carer groups
* Filling in questionnaires at the start and end of the groups
* Attending an interview with the researcher to discuss their experiences

The groups will be facilitated by a healthcare professional and a parent with lived experience. They will also be interviewed about their experiences after the groups have been completed. conditions: Complex Neurodevelopmental Disorder conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 28 type: ESTIMATED name: "Encompass" group programme measure: Group Attendance measure: Recruitment - percentage of eligible participants who consent to take part measure: Follow-up response rate-self-complete outcomes questionnaire(s) measure: Fidelity - delivery on items described in the Fidelity Checklist measure: Family Empowerment Scale (FES) measure: Power Ladder Question (PLQ) measure: Parent Patient Activation Measure (P-PAM) measure: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) measure: Parent/carer Quality of Life - EuroQoL-5D-5-level (EQ-5D-5L) measure: Parent/carer Needs and Goals measure: Childhood Cost Calculator (C3) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Barts Health NHS Trust, Children's Occupational Therapy, Mile End Hospital city: London zip: E1 4EH country: United Kingdom name: Frances Badenhorst role: CONTACT lat: 51.50853 lon: -0.12574 facility: East London NHS Foundation Trust, Specialist Children's and Young People's Services city: London zip: E15 4PT country: United Kingdom name: Melissa Homer role: CONTACT lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06310668 id: CBT IN substance use disorder briefTitle: Has CBT an Effect on Emotional Intelligence in Patients With Substance Use Disorder? overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-09 date: 2024-10 date: 2024-03-15 date: 2024-03-15 name: Egyptian Medical Syndicate class: OTHER briefSummary: Aim of the study: In this study, the change in emotional intelligence will be assessed before and after group CBT sessions in male patients with substance use disorder in the inpatient department of the addiction unit at Mansoura University Hospital. conditions: Substance Use Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized clinical trial primaryPurpose: TREATMENT masking: NONE count: 84 type: ESTIMATED name: group cognitive behavioral therapy sessions measure: emotional intelligence sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06310655 id: 202403078 briefTitle: Online Proton Adaptive Radiotherapy acronym: PARTy overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-05-15 date: 2025-08-31 date: 2024-03-15 date: 2024-04-11 name: Washington University School of Medicine class: OTHER briefSummary: This is a pilot study evaluating the feasibility of daily online adaptive planning for patients undergoing proton radiation therapy.

Patients undergoing proton radiation therapy normally undergo extensive pre-planning for their treatment. However, accounting for uncertainties in treatment delivery remains a challenge for a variety of reasons, such as differences in patient anatomy from pre-planning to the day of treatment. Online adaptive planning is a process consisting of generating the original pre-plan on the patient on a treatment day, assessing the pre-plan's coverage and safety, and if changes are needed, the plan is changed in order to optimize the treatment while the patient is still on the treatment table. This study is assessing the feasibility and safety of this approach in order to gather data for a larger trial. conditions: Solid Tumor studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All patients will receive 5 fractions of proton radiotherapy for their cancer. At the time of each fraction, the initial pre-plan will be compared to the newly generated adapted plan, and the optimal treatment will be administered. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Proton SBRT measure: Feasibility of online proton adaptive radiotherapy measure: Safety of online proton adaptive radiotherapy as measured by the amount of grade 2 and higher radiation-related toxicities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Washington University School of Medicine city: Saint Louis state: Missouri zip: 63110 country: United States name: Allen Mo, M.D., Ph.D. role: CONTACT phone: 314-717-2320 email: amo@wustl.edu name: Allen Mo, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR name: Hyun Kim, M.D. role: SUB_INVESTIGATOR name: Stephanie Perkins, M.D. role: SUB_INVESTIGATOR name: Joshua Schiff, M.D. role: SUB_INVESTIGATOR name: Weiren Liu, M.D. role: SUB_INVESTIGATOR name: Hailei Zhang, Ph.D. role: SUB_INVESTIGATOR name: Yi Huang, M.S. role: SUB_INVESTIGATOR name: Robbie Beckert role: SUB_INVESTIGATOR name: Eric Laugeman, M.S. role: SUB_INVESTIGATOR name: Farideh Pak, Ph.D. role: SUB_INVESTIGATOR name: Mike Watts, M.S. role: SUB_INVESTIGATOR name: Xiandong Zhao, Ph.D. role: SUB_INVESTIGATOR name: Tianyu Zhao, Ph.D. role: SUB_INVESTIGATOR lat: 38.62727 lon: -90.19789 hasResults: False

 nctId: NCT06310642 id: 2020-217 briefTitle: Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness acronym: PAMS overallStatus: COMPLETED date: 2021-05-20 date: 2023-03-13 date: 2023-03-13 date: 2024-03-15 date: 2024-03-15 name: CHRISTUS Health class: OTHER briefSummary: A field-based trial was conducted to determine if oral prochlorperazine demonstrates efficacy in the prophylactic treatment of AMS, and/or decreases the incidence of the symptoms of acute mountain sickness including headache, GI symptoms, fatigue and dizziness based on data collected in the Lake Louise AMS score. conditions: AMS conditions: Acute Mountain Sickness studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Enrolled a cohort of consenting, healthy subjects aged \>17 years. Thirty subjects enrolled in the study. 15 subjects received prochlorperazine. 15 subjects received placebo. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Patients were blinded in this study. whoMasked: PARTICIPANT count: 30 type: ACTUAL name: Immediate descent from altitude. name: Diphenhydramine name: Prochlorperazine 10 mg measure: Mean Lake Louise Acute Mountain Sickness Score (LLAMS) was utilized to compare symptoms of acute mountain sickness between the prochlorperazine and placebo groups measure: Subjects meeting Lake Louise Acute Mountain Sickness Score (LLAMS) criteria for acute mountain sickness between the prochlorperazine and placebo groups sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHRISTUS Health-Texas A&M Spohn Emergency Medicine Residency city: Corpus Christi state: Texas zip: 78405 country: United States lat: 27.80058 lon: -97.39638 hasResults: False

 nctId: NCT06310629 id: CMUH112-REC3-163 briefTitle: Oxygenation Efficacy of "Intrinseque Health" Non-Rebreathing Mask ("IHNRM") overallStatus: RECRUITING date: 2024-02-22 date: 2025-02-21 date: 2025-05-21 date: 2024-03-15 date: 2024-03-15 name: China Medical University Hospital class: OTHER briefSummary: Based on early bench-testing data and subsequent clinical case studies in the U.S., "Intrinseque Health" non-rebreathing mask (IHNRM) has delivered virtual elimination of air entrainment and preferential delivery of all available oxygen first into the alveolar spaces by sequential opening of valves in its controller manifold, even at oxygen flow as low as 10 LPM, patient can attain high alveolar oxygen concentration of 75% or more-far higher than attainable with face mask or nasal cannula.

Numerous intubated patients emerging from the operating room require intensive critical care specialist supervision in order to transition to the regular care. This would enable higher patient turnover and more efficient utilization of hospital resources, if patient can be transited to the regular care earlier by using a device that supports high oxygenation. This will enable a faster, safe and smooth extubation in critical care, and earlier discharge from intensive care ward.

This study is anticipated to take only around 2.5 hour per patient to complete. Patients meeting the inclusion and exclusion criteria of this study are placed on IHNRM and monitored until steady state of SpO2 of 95% or higher on 7-10 LPM has been maintained for at least 2 hours, when they can be discharged from the post-anesthesia care unit (PACU) to the regular care ward.

The study is the parallel design study. 60 patients will be randomly selected to use the IHNRM, and 30 subjects will be placed on HFNC. Blood oxygen concentration (SpO2), respiratory rate, end tidal CO2 concentration (EtCO2), and vital sign will be recorded in the study. The endpoint of the study is to compare the effect after using between "IHNRM" and HFNC. conditions: Respiratory Disease conditions: Respiratory Distress Syndrome conditions: Respiratory Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 90 type: ESTIMATED name: High Flow Nasal Cannula name: "Intrinseque Health" Non-Rebreathing Mask ("IHNRM") measure: Time to reach SpO2 Criteria in Run-in measure: The percentage of subjects to reach SpO2 Criteria in maintenance sex: ALL minimumAge: 3 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Internal Medicine, China Medical Univdersity Hospital status: RECRUITING city: Taichung country: Taiwan name: Chih-Chihng Yen, MD, PhD role: CONTACT phone: 886-4-22052121 phoneExt: 3483 email: d5210@mail.cmuh.org.tw name: Chih-Ching Yen, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 24.1469 lon: 120.6839 hasResults: False

 nctId: NCT06310616 id: 219888 briefTitle: A Study to Investigate the Potential Drug-Drug Interaction Between VH4524184 and Oral Contraceptive (Loestrin) in Healthy Adult Female Participants overallStatus: RECRUITING date: 2024-03-06 date: 2024-05-28 date: 2024-05-28 date: 2024-03-15 date: 2024-03-15 name: ViiV Healthcare class: INDUSTRY briefSummary: This study aims to assess any impact of VH4524184 on the pharmacokinetic (PK) profile of an ethinyl estradiol (EE) and norethindrone acetate (NEA) containing oral contraceptive (OC) administered to healthy adult female participants. conditions: HIV Infections studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: VH4524184 name: Loestrin measure: Area under the concentration-time curve (AUC) from time zero (pre-dose) to the end of the dosing interval at steady state (AUC0-Tau, ss) of EE and NEA without coadministration with VH4524184 measure: AUC0-Tau, ss of EE and NEA with coadministration with VH4524184 measure: Maximum plasma concentration (Cmax) for EE and NEA without coadministration with VH4524184 measure: Cmax for EE and NEA with coadministration with VH4524184 measure: Number of participants with adverse events (AEs) and severity of AEs measure: Number of participants with AEs leading to discontinuation of study intervention measure: Change from baseline of liver panel laboratory parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ASP) (International units per liter) measure: Change from baseline of liver panel laboratory parameters: Total bilirubin, Direct bilirubin (Micromoles per liter [umol/L]) measure: Change from baseline of liver panel laboratory parameters: International normalized ratio (INR) (Ratio) measure: Number of participants with maximum toxicity grade increase from baseline of liver panel laboratory parameters: ALT, AST, alkaline phosphatase, total bilirubin, Direct bilirubin, and INR measure: Maximum plasma concentration at steady state (Cmax,ss) for VH4524184 measure: Time to maximum concentration at steady state (Tmax, ss) during dosing interval for VH4524184 measure: Area under the concentration-time curve from time zero(pre-dose) to the end of the dosing interval at steady state (AUC0-Tau, ss) for VH4524184 measure: Trough concentration prior to the next dose (Ctrough) for VH4524184 sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: GSK Investigational Site status: RECRUITING city: San Antonio state: Texas zip: 78209 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Chinonye Chika Ogbonnaya-Odor role: PRINCIPAL_INVESTIGATOR lat: 29.42412 lon: -98.49363 hasResults: False

 nctId: NCT06310603 id: IRB-23-42 briefTitle: Determinants and Outcomes of High vs. Low Ultra-processed Feeding overallStatus: RECRUITING date: 2023-08-09 date: 2024-05-15 date: 2025-08-09 date: 2024-03-15 date: 2024-03-15 name: Oklahoma State University class: OTHER briefSummary: The goal of this clinical trial is to learn about, test, and compare health outcomes of high vs. low-processed feeding. The main question\[s\] it aims to answer are:

• Does consuming a diet rich in unprocessed food improve various health outcomes? Participants will either be instructed to consume a diet rich in unprocessed food for 6 months, or consume their typical diet for 6 months. At various points in the study there will be metabolic health data collected.

If there is a comparison group: Researchers will compare the low-processed group to the typical diet group to see if there are improvements in metabolic health. conditions: Healthy Nutrition studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Low-Processed Food Diet measure: Body Weight measure: Body Composition measure: Fat Mass Percentage measure: Fat-Free Mass Percentage measure: Triglyceride Levels measure: Glucose Levels measure: Cholesterol Levels measure: HDL measure: LDL measure: Alanine transaminase (ALT) measure: Aspartate transaminase (AST) measure: Energy Intake measure: Energy Expenditure measure: Gut Microbiome Collection sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Laboratory for Applied Nutrition and Exercise Science (LANES) status: RECRUITING city: Stillwater state: Oklahoma zip: 74075 country: United States name: Sam Emerson, PhD role: CONTACT email: sam.emerson@okstate.edu name: Tyler Godsey, B.S. role: CONTACT phone: 405-744-7708 email: tylgods@okstate.edu name: Sam Emerson, PhD role: PRINCIPAL_INVESTIGATOR lat: 36.11561 lon: -97.05837 hasResults: False

 nctId: NCT06310590 id: NRT6003-HCC-2022 id: CTR20230515 type: OTHER domain: Center for Drug Evaluation, NMPA briefTitle: Safety and Efficacy of NRT6003 in Patients With Unresectable Hepatocellular Carcinoma overallStatus: RECRUITING date: 2023-08-08 date: 2025-10-31 date: 2025-10-31 date: 2024-03-15 date: 2024-03-15 name: Chengdu New Radiomedicine Technology Co. LTD. class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the safety and efficacy of NRT6003 Injection in patients with unresectable HCC. conditions: Unresectable Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: NRT6003 Injection measure: Adverse events/ Severe adverse events measure: Localized Objective response rates (ORR) measure: Hepatic time to progression (hTTP) measure: Duration of response (DOR) measure: Disease control rate (DCR) measure: Time to progression (TTP) measure: Progression Free Survival (PFS) measure: Concentration of Alpha fetoprotein (AFP) measure: Quality of life (QoL) measure: Yttrium-90 distribution measure: Resection rate of liver target lesions measure: Radioactivity of Yttrium-90 for 9 participants, assessed by liquid scintillation counter sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Provincial Hospital status: RECRUITING city: Hefei state: Anhui country: China name: Lianxin Liu role: CONTACT name: Lianxin Liu role: PRINCIPAL_INVESTIGATOR lat: 31.86389 lon: 117.28083 facility: Fujian Provincial Cancer Hospital status: RECRUITING city: Fuzhou state: Fujian country: China name: Hailan Lin role: CONTACT name: Hailan Lin role: PRINCIPAL_INVESTIGATOR lat: 26.06139 lon: 119.30611 facility: The First Affiliated Hospital of Xiamen University status: RECRUITING city: Xiamen state: Fujian country: China name: Jinxiong Huang role: CONTACT name: Jinxiong Huang role: PRINCIPAL_INVESTIGATOR lat: 24.47979 lon: 118.08187 facility: The First Affiliated Hospital of Jinan University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Hao Xu role: CONTACT name: Hao Xu role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Henan Cancer Hospital status: RECRUITING city: Zhengzhou state: Henan country: China name: Hailiang Li role: CONTACT name: Hui Yang role: CONTACT name: Hailiang Li role: PRINCIPAL_INVESTIGATOR name: Hui Yang role: PRINCIPAL_INVESTIGATOR lat: 34.75778 lon: 113.64861 facility: Hunan Provincial People's Hospital status: RECRUITING city: Changsha state: Hunan country: China name: Hua Xiang role: CONTACT name: Hua Xiang role: PRINCIPAL_INVESTIGATOR lat: 28.19874 lon: 112.97087 facility: Zhongda Hospital, Southeast University status: RECRUITING city: Nanjing state: Jiangsu zip: 210009 country: China name: Gaojun Teng, MD role: CONTACT phone: +8602583272084 email: zdyyjgb@163.com name: Gaojun Teng, MD role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 facility: The First Hospital of China Medical University status: RECRUITING city: Shenyang state: Liaoning country: China name: Haibo Shao role: CONTACT name: Haibo Shao role: PRINCIPAL_INVESTIGATOR lat: 41.79222 lon: 123.43278 facility: West China Hospital, Sichuan University status: RECRUITING city: Chengdu state: Sichuan country: China name: Hong Wu role: CONTACT name: Hong Wu role: PRINCIPAL_INVESTIGATOR lat: 30.66667 lon: 104.06667 facility: The Affiliated Hospital of Southwest Medical University status: RECRUITING city: Luzhou state: Sichuan country: China name: Yue Chen role: CONTACT name: Yue Chen role: PRINCIPAL_INVESTIGATOR facility: Zhejiang Cancer Hospital status: RECRUITING city: Hangzhou state: Zhejiang zip: 310022 country: China name: Guoliang Shao role: CONTACT name: Guoliang Shao role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 facility: The First Affiliated Hospital, Zhejiang University School of Medicine status: RECRUITING city: Hangzhou state: Zhejiang country: China name: Tingbo Liang role: CONTACT name: Tingbo Liang role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 facility: The First Affiliated Hospital of Wenzhou Medical University status: RECRUITING city: Wenzhou state: Zhejiang country: China name: Chang Yu role: CONTACT name: Chang Yu role: PRINCIPAL_INVESTIGATOR lat: 27.99942 lon: 120.66682 facility: The Southwest Hospital of Army Medical University status: RECRUITING city: Chongqing country: China name: Leida Zhang role: CONTACT name: Leida Zhang role: PRINCIPAL_INVESTIGATOR lat: 29.56278 lon: 106.55278 facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai country: China name: Wentao Li role: CONTACT name: Wentao Li role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: The First Affiliated Hospital of Naval Medical University status: RECRUITING city: Shanghai country: China name: Changjing Zuo role: CONTACT name: Changjing Zuo role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: The Third Affiliated Hospital of Naval Medical University status: RECRUITING city: Shanghai country: China name: Hui Liu role: CONTACT name: Hui Liu role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: Zhongshan Hospital, Fudan University status: RECRUITING city: Shanghai country: China name: Zhiping Yan role: CONTACT name: Hongcheng Shi role: CONTACT name: Zhiping Yan role: PRINCIPAL_INVESTIGATOR name: Hongcheng Shi role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: Tianjin Medical University Cancer Insititute & Hospital status: RECRUITING city: Tianjin country: China name: Wei Lu role: CONTACT name: Wei Lu role: PRINCIPAL_INVESTIGATOR lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06310577 id: EH23-343 briefTitle: Evaluation of Leak-Free Bronchoscope Adapter to Limit Ventilated Air Volume Loss During Bronchoscopy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-11 date: 2026-11 date: 2024-03-15 date: 2024-03-15 name: NorthShore University HealthSystem class: OTHER briefSummary: The purpose of this research is to evaluate the ability of a new bronchoscope adapter called "leak-free adapter" to limit the amount of air leaking out to the operating room (OR) from the ventilator in intubated patients who undergo bronchoscopy. conditions: Pulmonary Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Self-controlled primaryPurpose: TREATMENT masking: NONE count: 44 type: ESTIMATED name: Leak-free bronchoscope adapter measure: Number of participants able to undergo bronchoscopic evaluation using the "leak-free adapter" measure: Heart rate (bpm) measure: Blood pressure (mmHg) measure: Oxygenation as measured by SpO2 measure: Assessment of adverse events measure: Evaluation of bronchoscope adapter tidal volume loss efficacy measure: Evaluation of bronchoscope adapter aerosolization efficacy measure: Peak airway pressure (cmH2O) measure: Dynamic compliance (mL/CmH2O) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06310564 id: 2023-18 briefTitle: Low and Intermediate Risk oliGometastatic coloREctal cancEr patieNts Treated With Stereotactic ABlative Radiotherapy acronym: GREENLaIT-SABR overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2031-04 date: 2031-04 date: 2024-03-15 date: 2024-03-15 name: IRCCS Sacro Cuore Don Calabria di Negrar class: OTHER briefSummary: This is an experimental study without drug or device, randomized, open-label, non-profit, sponsored by the IRCCS Sacro Cuore Don Calabria Hospital in Negrar, which will take place at the Department of Advanced Oncological Radiotherapy and 18 other Italian centers.

The reason for this research study is to evaluate whether stereotactic radiotherapy treatment (SABR), in addition to the systemic chemotherapy treatment foreseen by clinical practice for low-intermediate risk oligometastatic colorectal cancer, is able to:

* delay possible local recurrence and/or distant polymetastatic progression
* improve disease-free survival
* reduce side effects in the short and long term

thus inducing an improvement in the quality of life of patients suffering from this type of pathology.

Therefore, as part of this randomized study, before starting first or second line systemic therapy for his tumor, the patient will be randomized to one of the following treatment arms:

* Experimental arm: ablative stereotactic radiotherapy on all sites of oligometastatic disease (from 1 to 3 sites, performed at most within the second cycle of systemic therapy)
* Control arm: no ablative stereotactic radiotherapy to sites of oligometastatic disease

The procedure that is intended to be tested in the experimental arm is a stereotactic radiotherapy treatment on oligometastases (up to a maximum of 3 sites), with ablative dosage (effective biological dose \>100 Gy), performed before the start of systemic therapy of I or II line (at most within the second cycle of the same).

It is hoped that the addition of this type of radiotherapy will increase the potential clinical benefit of the treatment in the context of colorectal cancer. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 204 type: ESTIMATED name: SABR measure: Progression-free survival (PFS). measure: Time to the polymetastatic conversion (tPMC) measure: Local control (LC): the time between randomization to the date of radiological development of local progression after SABR. measure: Overall survival (OS) measure: Time to start of the next systemic treatment line (NEST) measure: Number of adverse events as assessed by CTCAE v4.0 measure: Number of acute side-effects measure: Number of Late side-effects measure: questionnaire QLQ-C30 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Sacro Cuore Don Calabria di Negrar city: Negrar state: Verona zip: 37024 country: Italy name: Luca Nicosia, Doctor role: CONTACT phone: +39(0)456014800 email: luca.nicosia@sacrocuore.it lat: 45.52918 lon: 10.93899 hasResults: False

 nctId: NCT06310551 id: 218804 briefTitle: First Time in Human Study of Long Acting VH4524184 Formulations overallStatus: NOT_YET_RECRUITING date: 2024-03-14 date: 2025-02-13 date: 2026-11-27 date: 2024-03-15 date: 2024-03-15 name: ViiV Healthcare class: INDUSTRY name: GlaxoSmithKline briefSummary: The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection. conditions: HIV Infections studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 72 type: ESTIMATED name: Oral VH4524184 name: VH4524184 Formulation A SC name: Placebo Formulation A SC name: rHuPH20 name: VH4524184 Formulation B SC name: Placebo Formulation B SC name: VH4524184 Formulation C SC name: Placebo Formulation C SC name: VH4524184 Formulation A IM name: Placebo Formulation A IM measure: Percentage of participants reporting AEs and related AEs measure: Percentage of participants with AEs by severity measure: Percentage of participants discontinuing the treatment due to AEs measure: Liver panel laboratory parameters (Alanine aminotransferase [ALT], Aspartate aminotransferase [AST] and alkaline phosphatase) change from baseline after the administration of LAI VH4524184 measure: Liver panel laboratory parameters (total bilirubin) change from baseline after the administration of LAI VH4524184 measure: Liver panel laboratory parameters (International normalized ratio) change from baseline after the administration of LAI VH4524184 measure: Maximum toxicity grade increase from baseline in liver panel laboratory parameters (ALT, AST and alkaline phosphatase) measure: Maximum toxicity grade increase from baseline in liver panel laboratory parameters (total bilirubin) measure: Maximum toxicity grade increase from baseline in liver panel laboratory parameters (International normalized ratio) measure: Percentage of participants reporting injection site reaction (ISR) AEs measure: Duration of injection site reaction AEs measure: Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinity time (AUC[0-inf]) of Long-Acting Injectable (LAI) VH4524184 following single dose administration measure: Area under the plasma drug concentration-time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-t]) of LAI VH4524184 following multiple dose administration measure: Maximum observed plasma drug concentration (Cmax) of LAI VH4524184 following single dose administration measure: Cmax of LAI VH4524184 following multiple dose administration measure: Time to maximum observed plasma drug concentration (Tmax) of LAI VH4524184 following single dose administration measure: Tmax of LAI VH4524184 following multiple dose administration measure: Apparent terminal half-life (t1/2) of LAI VH4524184 following single dose administration measure: t1/2 of LAI VH4524184 following multiple dose administration measure: Percentage of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: GSK Investigational Site city: Lenexa state: Kansas zip: 66219 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Patrick Yao role: PRINCIPAL_INVESTIGATOR lat: 38.95362 lon: -94.73357 facility: GSK Investigational Site city: San Antonio state: Texas zip: 78209 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Chinonye Chika Ogbonnaya-Odor role: PRINCIPAL_INVESTIGATOR lat: 29.42412 lon: -98.49363 hasResults: False

 nctId: NCT06310538 id: 2024BZYLL0110 briefTitle: Clinical Study on the Treatment of Breast Hyperplasia With Kou Sha Therapy Based on Real World overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-05 date: 2024-05 date: 2024-03-15 date: 2024-03-15 name: Hongguo Rong class: OTHER briefSummary: In this study, epidemiological prospective real-world cohort study design was adopted. The Third Affiliated Hospital of Beijing University of Chinese Medicine and the First Hospital of Handan City, Hebei Province were selected. From the same time appointed before the study, all breast hyperplasia participants who met the admission criteria choosing Kou Sha therapy or routine treatment of western medicine were selected in the sample hospitals.The first 30 participants were included in the planned Kou Sha therapy group while the first 30 participants were included in the control group.Taking the change of the total score of breast pain (McGill Pain Questionnaire Short Form score+breast pain score) as the main curative effect index, and taking McGill pain questionnaire score, breast color ultrasound score, palpation lump score, quality of life, anxiety and depression symptoms, sleep and so on as the secondary curative effect indexes to observe the clinical effect of the method of Kou Sha therapy on breast hyperplasia. The research period is from March 2024 to May 2024. conditions: Breast Hyperplasia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: kou sha name: Hongjin Xiaojie Capsules measure: Breast pain score measure: Short Form McGill Pain Inquiry Scale (SF-MPQ) measure: Breast color ultrasound score measure: Palpation lump score measure: Depression symptoms measure: Anxiety symptoms measure: The quality of life rating scale (QOL) sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06310525 id: DROWN_DDF2 briefTitle: Using Machine Learning to Optimise the Danish Drowning Formula acronym: DROWN_DDF2 overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-15 date: 2024-03-25 name: Prehospital Center, Region Zealand class: OTHER briefSummary: The Danish Drowning Formula (DDF) was designed to search the unstructured text fields in the Danish nationwide Prehospital Electronic Medical Record on unrestricted terms with comprehensive search criteria to identify all potential water-related incidents and achieve a high sensitivity. This was important as drowning is a rare occurrence, but it resulted in a low Positive Predictive Value for detecting drowning incidents specifically. This study aims to augment the positive predictive value of the DDF and reduce the temporal demands associated with manual validation. conditions: Drowning conditions: Drowning and Submersion While in Bath-Tub conditions: Drowning and Submersion While in Natural Water conditions: Drowning and Submersion While in Swimming-Pool conditions: Drowning and Submersion Due to Fall Off Ship conditions: Drowning and Nonfatal Submersion conditions: Drowning, Near conditions: Drowning; Asphyxia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1500 type: ESTIMATED name: Drowning incident measure: Sensitivity of the machine learning algorithm as a drowning identification tool measure: Specificity of the machine learning algorithm as a drowning identification tool measure: PPV of the machine learning algorithm measure: NPV of the machine learning algorithm sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Prehospital Center city: Næstved state: Region Zealand zip: 4700 country: Denmark lat: 55.22992 lon: 11.76092 hasResults: False

 nctId: NCT06310512 id: ANZHEN HOSPITOL-LY-04 briefTitle: Efficacy of Pharmacist Interventions Through the "Medication Therapy Management Pathway in Hypertensive Patients" acronym: PharmMTMH overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2026-06-30 date: 2024-03-15 date: 2024-03-15 name: Beijing Anzhen Hospital class: OTHER briefSummary: The goal of this Randomized Controlled Trial is to carry out in adult patients with primary hypertension whose blood pressure control is not up to standard. The main question it aims to answer are:

To explore the effect of pharmacists' implementation of "the medication therapy management pathway in hypertensive patients"on the patients with hypertension.

Participants will receive structured drug treatment management at the first diagnosis. During on-site follow-up in the first, third and sixth months, as well as telephone follow-up in the second week, second and fourth months, patients will be evaluated, corresponding information will be collected and possible interventions will be taken.

Researchers will compare the non intervention group to see if patients' blood pressure will also be reduced without intervention. conditions: Hypertension conditions: Medication Therapy Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 420 type: ESTIMATED name: Structured drug therapy management measure: systolic blood pressure measure: diastolic blood pressure measure: Change from baseline in mean sitting systolic blood pressure at 3 months measure: Change from baseline in number of medication-related problems (MRP) at 6 months measure: Average number of medication-related problems (MRP) resolved after 6 months measure: The compliance rate of blood pressure after 6 months measure: Effective rate of blood pressure lowering after 6 months measure: Time to BP Attainment in Intervention and Non-Intervention Groups measure: Changes from baseline in adherence scores at 6 months,the General Medication Compliance Scale (GMAS) was used. measure: Economic indicators，mainly including the cost of implementing intervention measures and the impact of intervention measures on patient diagnosis and treatment costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Anzhen Hospital city: Beijing state: Beijing zip: 100029 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06310499 id: DROWN_COD briefTitle: Primary or Secondary Drowning acronym: DROWN_COD overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-15 date: 2024-03-15 name: Prehospital Center, Region Zealand class: OTHER briefSummary: According to WHO's rules, any death certificate must state the underlying cause of death and contributory causes of death may also be stated.

Differentiating between primary and secondary drowning is difficult, as information preceding the drowning incident is rarely available. Yet, knowing the most frequent causes of secondary drowning may provide useful information to healthcare professionals working in prehospital Emergency Medical Services, as this may affect prehospital treatment. conditions: Drowning conditions: Drowning; Anoxia conditions: Drowning, Near conditions: Drowning in Swimming Pool conditions: Drowning; Asphyxia conditions: Drowning/Diving/SCUBA Accident conditions: Drowning or Immersion of Unknown Intent conditions: Drowning and Submersion, Undetermined Intent conditions: Drowning and Submersion While in Bath-Tub conditions: Drowning and Submersion While in Natural Water conditions: Drowning and Submersion Due to Sailboat Sinking conditions: Drowning and Submersion Due to Fall Off Ship conditions: Drowning and Submersion While in Swimming-Pool studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 700 type: ESTIMATED name: Drowning measure: Autopsy rate measure: Primary fatal drowning rate measure: Secondary fatal drowning rate sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Prehospital Center city: Næstved state: Region Zealand zip: 4700 country: Denmark lat: 55.22992 lon: 11.76092 hasResults: False

 nctId: NCT06310486 id: DROWN_CALL briefTitle: The Emergency Call on Drowning acronym: DROWN_CALL overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-15 date: 2024-03-15 name: Prehospital Center, Region Zealand class: OTHER briefSummary: This study aims to 1) describe patient-, setting-, and dispatcher-related characteristics in drowning-related emergency calls to the Emergency Medical Dispatch Centre (1-1-2 emergency phone) and 2) factors associated with 30-day survival. The investigators will separately analyse drowning-related out-of-hospital cardiac arrest (OHCA) and drowning-related non-OHCA. If feasible, the investigators will qualitatively analyse the calls to identify and describe potential barriers for an optimal handling strategy. conditions: Drowning conditions: Drowning; Anoxia conditions: Drowning, Near conditions: Drowning; Asphyxia conditions: Drowning and Nonfatal Submersion conditions: Drowning or Immersion of Unknown Intent conditions: Drowning and Submersion, Undetermined Intent conditions: Drowning and Submersion While in Bath-Tub conditions: Drowning and Submersion While in Natural Water conditions: Drowning and Submersion Due to Sailboat Sinking conditions: Drowning and Submersion Due to Fall Off Ship conditions: Drowning and Submersion While in Swimming-Pool studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1500 type: ESTIMATED name: Drowning-related OHCA name: Drowning-related non-OHCA measure: Patient-related characteristics influencing the 30-day survival measure: Setting-related characteristics influencing the 30-day survival measure: Caller-related characteristics influencing the 30-day survival measure: Dispatcher-related characteristics influencing the 30-day survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Prehospital Center city: Næstved state: Region Zealand zip: 4700 country: Denmark lat: 55.22992 lon: 11.76092 hasResults: False

 nctId: NCT06310473 id: NFEC-2023-582 briefTitle: Neoadjuvant Cadonilimab Plus Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer Trial overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2028-03 date: 2024-03-15 date: 2024-03-15 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: For locally advanced esophagogastric junction and gastric cancer, neoadjuvant chemotherapy can downstage T and N stage,treated distant micrometastases early , and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced esophagogastric junction and gastric cancer could be a novel therapy to increase response rate and reduce recurrence rate.Cadonilimab, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of cadonilimab Plus Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer. conditions: Gastric Cancer conditions: Esophagogastric Junction Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Cadonilimab name: Oxaliplatin name: Capecitabine measure: Pathologic complete remission rate (pCR) measure: Major pathologic response，MPR measure: R0 resection rate measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: 3-year disease-free survival rate of 3year (DFS) measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanfang Hospital, Southern Medical University city: Guangzhou state: Guangdong zip: 510-515 country: China name: Guoxin Li, M.D., Ph.D. role: CONTACT phone: +86-138-0277-1450 email: gzliguoxin@163.com name: Guoxin Li, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR name: Liying Zhao, M.D., Ph.D. role: SUB_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06310460 id: PCP briefTitle: Evaluation of "PreCut-Papillectomy" in Difficult Biliary Cannulation overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2025-02-28 date: 2024-03-15 date: 2024-03-15 name: Kliniken Ludwigsburg-Bietigheim gGmbH class: OTHER briefSummary: To evaluate the effectiveness and sefety of papillectomy to enable bile duct access during endoscopic retrograde cholangiography in patients with difficult biliary cannulation. conditions: Cholangiopancreatography, Endoscopic Retrograde studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Papillectomy measure: Rate of treatment success measure: Adverse event rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06310447 id: IstanbulBUFC2 briefTitle: Determination of Ecological Awareness and Attitudes Levels of Undergraduate Physiotherapy Students in Istanbul overallStatus: COMPLETED date: 2024-03-18 date: 2024-04-01 date: 2024-04-03 date: 2024-03-15 date: 2024-04-04 name: Istanbul Bilgi University class: OTHER briefSummary: The natural environment, which is the living environment of all living things; Technological advances and industrialization activities are being affected more and more negatively every day. Increasing energy demand and resource consumption due to population growth lead to negative consequences on ecological balance, such as environmental pollution, climate change and loss of natural environments. Health services have also increased resource use with the advancement of technology and caused negative effects on the environment. Health services have been slow to understand their impact on the environment. The aim of the study is to determine the environmental awareness and environmental attitude levels of physiotherapy and rehabilitation department students, to popularize the field of "Environmental Physiotherapy" and to enable the training of physiotherapist candidates with high environmental awareness. conditions: Ecological and Environmental Concepts studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 151 type: ACTUAL measure: Ecological Footprint Awareness Scale measure: Environmental Awareness Scale measure: Environmental Attitude Scale measure: Participant Information Form sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Istanbul Bilgi University city: Istanbul zip: 34440 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06310434 id: PI23/00409 briefTitle: Analysis of COMPASsion and Humanisation of Adolescents Facing the End-of-life Processes. acronym: COMPAS overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-12 date: 2026-12 date: 2024-03-15 date: 2024-03-19 name: Instituto de Salud Carlos III class: OTHER_GOV briefSummary: The investigators want to work on compassion, understood as the recognition of the suffering of others that motivates us to try to alleviate it. The goal of this Multicenter project, with a mixed sequential transformative methodology, is to analyze the impact of a participatory process of awareness and reflection on compassion, in the face of end-of-life processes, in adolescents aged 12-23 years in 6 Spanish provinces, and to understand how the participatory process can transform and improve their compassion.

As the adolescents must be the protagonists of change, the study will be conducted with students enrolled in one public secondary school and in one degree in a public University, that belongs to the same "health area" in each province. The investigators also include families' and teachers' knowledge of the context because it can support the interventions of change proposals.

Compassion will be assessed using the Compassion for the Lives of Others Scale (COOLS), comprising 26 items. Similarly, adolescents' attitudes toward death are another important concept and will be explored through the Death Anxiety Scale (DAS), which has 15 questions. Both scales will be distributed to the adolescents, requesting their permission anonymously.

After the survey, a second phase will start with a Participatory Action Research (PAR) with different activities. The objective is to generate awareness of the need to improve it, allowing the participants to design the interventions, based on evidence-based proposals (cinema forum, colloquiums with testimonies of volunteers accompanying palliative patients, organization of Death Cafe, artistic and literary activities, generation of grief groups, etc.).

At the end of the project, the investigators will evaluate the adolescent compassion level and create discussion groups again to understand the impact of the interventions.

With this project, the investigators will empower new generations of people to encourage, facilitate, support, and celebrate mutual care and family and community development in end-of-life processes. The translation and implications of the results for clinical practice will contribute to reducing inequalities in health research in a vulnerable group of special interest, especially when treatments can do nothing for their survival but with interventions such as those in this study, the investigators can ensure quality and dignity of life as long as there is life. conditions: Compassion conditions: Death Anxiety conditions: Adolescent Behavior studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1852 type: ESTIMATED name: questionnaire name: Discussion group name: Reflective diary measure: Describe and improve the level of compassion of high school and university students. measure: Describe and improve the attitude towards death of high school and university students. sex: ALL minimumAge: 12 Years maximumAge: 23 Years stdAges: CHILD stdAges: ADULT facility: Instituto Murciano de Investigación Biosanitaria city: Murcia state: MU zip: 30120 country: Spain name: Eva Abad-Corpa, PhD role: CONTACT email: eva.abad@um.es name: Miriam Espinosa-Sánchez, MhD role: CONTACT email: miriam.espinosa1@um.es lat: 37.98704 lon: -1.13004 hasResults: False

 nctId: NCT06310421 id: Screening_SMA briefTitle: Spinal Muscular Atrophy Neonatal Screening Program overallStatus: RECRUITING date: 2023-10-16 date: 2026-05-31 date: 2026-05-31 date: 2024-03-15 date: 2024-03-18 name: IRCCS Burlo Garofolo class: OTHER briefSummary: Spinal muscular atrophy (SMA) is a group of disorders caused by the degeneration of the motor neuron cells of the anterior horn of the spinal cord and, in some subtypes, of the bulbar motor neurons. Almost all cases are genetically determined. Most SMAs are autosomal recessive diseases, caused by homozygous deletions of the survival motor neuron (SMN) gene located on the long arm of chromosome 5. The estimated incidence of recessive childhood and juvenile SMA linked to deletion of the SMN gene is 1 in 6000 to 10000 live births, with a carrier frequency of 1 in 35 in the general population, making it a major genetic cause of infant mortality. Up to 95-97% of all childhood cases are due to homozygous deletions of the survival motor neuron 1 (SMN1) gene, or telomeric SMN, located on chromosome 5q11.2-13.3. The remaining 3-5% of cases are due to small mutations in SMN1 (rather than complete deletions).

Until a few years ago, the prognosis of type 1 SMA was poor. In the absence of therapies, the only measures were supportive (ventilation, nutrition) and the prospect, especially in the early forms, was to accompany them towards an early end of life. There are currently three treatment options available: nusinersen, risdiplam, and gene therapy with onasemnogene abeparvovec. The three options were found to be equally effective in reducing the symptoms of the disease, making it possible to reach or safeguard fundamental stages in a child's neuromotor development, starting from the ability to remain seated. At this moment, gene therapy is probably the preferred choice. To date, in Italy, there are approximately 100 patients undergoing gene therapy.

To ensure maximum benefit for affected patients, it is essential that the therapy is administered as soon as possible. Literature shows how the administration of gene therapy in pre-symptomatic subjects made it possible to achieve a better neurological outcome compared to symptomatic patients. From this perspective, the inclusion of spinal muscular atrophy in neonatal screening is of fundamental relevance. conditions: Spinal Muscular Atrophy studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: PROSPECTIVE count: 11500 type: ESTIMATED name: Screening SMA test measure: Rate of newborn screened sex: ALL minimumAge: 48 Hours maximumAge: 72 Hours stdAges: CHILD facility: SC Pediatria Gorizia - Monfalcone status: RECRUITING city: Monfalcone state: Gorizia country: Italy name: Danica Dragovic, MD role: CONTACT phone: +39 0481 487252 email: danica.dragovic@asugi.sanita.fvg.it lat: 45.80463 lon: 13.53292 facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" status: RECRUITING city: Trieste zip: 34137 country: Italy name: Sheila Ulivi, MSc role: CONTACT phone: +36.040 3785 226 email: sheila.ulivi@burlo.trieste.it name: Luca Ronfani, PhD MD role: CONTACT phone: +39.040.3785.297 email: luca.ronfani@burlo.trieste.it lat: 45.64953 lon: 13.77679 hasResults: False

 nctId: NCT06310408 id: 0214022024 briefTitle: Comparison Between Nasal Mask vs Nasal Prong on Pain Response in Neonate overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-06-01 date: 2024-06-01 date: 2024-03-15 date: 2024-03-15 name: Indonesia University class: OTHER briefSummary: to determine the comparison of nasal masks and nasal prongs on the pain response of neonate conditions: Nasal Mask conditions: Nasal Prong studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1 group give nasal mask

1 group give nasal prong primaryPurpose: PREVENTION masking: NONE count: 44 type: ESTIMATED name: nasal mask name: nasal prong measure: pain response sex: ALL minimumAge: 26 Weeks maximumAge: 44 Weeks stdAges: CHILD hasResults: False

 nctId: NCT06310395 id: AMI_H.MAR briefTitle: Analysis of the Acute Mesenteric Ischemia in a Single Institution Over 10 Years acronym: AMI_HMAR overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2024-07-15 date: 2024-10-15 date: 2024-03-15 date: 2024-03-15 name: Hospital del Mar class: OTHER briefSummary: Acute mesenteric ischemia (AMI) is a notorious disease with a high mortality, the diagnostic and management is truly multidisciplinary, and the aim of this study is to analyse the results of the patients admited with an AMI in Hospital de Mar. conditions: Acute Mesenteric Ischemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED measure: Mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06310382 id: GH55-CRS001 briefTitle: A Phase I/II Clinical Study to Evaluate The Safety, PK, PD of GH55 in Patients With MAPK Mutant Advanced Solid Tumors overallStatus: RECRUITING date: 2022-12-07 date: 2025-05-26 date: 2025-08-04 date: 2024-03-15 date: 2024-03-18 name: Suzhou Genhouse Bio Co., Ltd. class: OTHER name: Shanghai East Hospital name: Shandong Tumor Hospital briefSummary: This is a multi-center, open-label, dose escalation phase I and dose expansion phase II study aimed to evaluate the safety, tolerability, PK and PD profiles as well as to observe the efficacy of GH55 in patients with MAPK mutant advanced solid tumors.

This study is divided into two parts, namely the dose escalation phase I study and the dose expansion phase II study. conditions: Advanced Solid Tumors With MAPK Signal Pathway Mutant studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 110 type: ESTIMATED name: GH55 measure: Number of participants with dose limiting toxicities measure: Number of participants with adverse events measure: Objective response rate (ORR) measure: Progression-free survival (PFS) measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Number of participants with adverse events measure: Plasma concentration (Cmax) measure: Time to achieve Cmax (Tmax) measure: Area under the plasma concentration-time curve (AUC) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai East Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200120 country: China name: JIN LI, DOCTORATE role: CONTACT phone: 021-38804518 email: lijin@csco.org.cn lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06310369 id: EORTC 2335-GUCG briefTitle: Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer overallStatus: NOT_YET_RECRUITING date: 2025-03-01 date: 2025-10-01 date: 2030-03-01 date: 2024-03-15 date: 2024-03-15 name: European Organisation for Research and Treatment of Cancer - EORTC class: NETWORK briefSummary: We aim to investigate a possible role for radiotherapy in good prognosis bladder cancer patients has been identified as a possible alternative to cystectomy, especially for patients non-eligible for surgery but has yet to be fully explored. conditions: Bladder Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: radiation therapy measure: Proportion of patients with a CR at 6 months post-radiotherapy measure: Progression-free survival measure: overall survival sex: MALE minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06310356 id: CORDELIA briefTitle: Continuous Glucose Monitoring for Women With Gestational Diabetes acronym: CORDELIA overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-09 date: 2027-02 date: 2024-03-15 date: 2024-03-18 name: Universitaire Ziekenhuizen KU Leuven class: OTHER name: University Hospital, Antwerp name: General Hospital Groeninge name: Onze Lieve Vrouw Hospital name: AZ Delta name: Ziekenhuis Netwerk Antwerpen (ZNA) name: Vitaz name: Centre Hospitalier Universitaire de Liege name: Erasme University Hospital name: Université Catholique de Louvain name: Centre Hospitalier Mouscron name: University Hospital, Ghent name: AZ Turnhout name: AZ Sint-Lucas Gent name: AZ St- Jan Brugge name: AZ St Maarten Mechelen name: Imelda Hospital, Bonheiden briefSummary: There are a few ongoing large randomized controlled trials (RCT's) on continuous glucose monitoring (CGM) in women with gestational diabetes (GDM) powered for pregnancy outcomes. However, none of these studies included women diagnosed with early GDM. The CORDELIA trial is a Belgian open-label multi-centric RCT with 17 centers in women with GDM (including both early and late GDM). Women will be randomized 1/1 to either treatment with CGM (intervention group, Freestyle Libre 3) or continue with self-monitoring of blood glucose (SMBG) with glucometer in line with normal routine (control arm). The study ends at the postpartum oral glucose tolerance test (OGTT 6-24 weeks postpartum) to screen for glucose intolerance. conditions: Gestational Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 386 type: ESTIMATED name: Freestyle Libre 3 name: Glucometer measure: a composite of pregnancy outcomes measure: time in glucose range overnight between 70-95mg/dl measure: time in glucose range during the day between 70-95mg/dl measure: time in glucose range overnight between 63-140mg/dl measure: time in glucoserange during the day between 63-140mg/dl measure: time in glucose range during the day between 54-95mg/dl measure: time in glucose range overnight between 54-95mg/dl measure: time in glucose range overnight between 63-120mg/dl measure: time in glucose range during the day between 63-120mg/dl measure: hypoglycemia <54mg/dl measure: hypoglycemia <50mg/dl measure: hypoglycemia <63mg/dl measure: hypoglycemia <70mg/dl measure: standard deviation measure: Coefficient of Variance measure: mean amplitude of glycemic excursions measure: glucose time overnight >100mg/dl measure: glucose postprandial time >120mg/dl measure: glucose postprandial time >140mg/dl measure: glucose time >180mg/dl measure: mean HbA1c measure: Glucose management indicator measure: timing of start insulin treatment measure: mean insulin dose measure: mean gestational weight gain measure: rate of postpartum hemorrhage measure: rate of macrosomia measure: rate of baby >4.5Kg measure: rate of Small-for-gestational age infant measure: rate of cesarean section measure: rate of instrumental delivery measure: rate of perineal inury measure: rate of labor inductions measure: rate of preeclamspia measure: rate of gestational hypertension measure: rate of fetal malformation measure: rate of miscarriage measure: rate of polycythemia measure: rate of neonatal hypoglycemia measure: Treatment satisfaction measure: Quality of life based on Short Form (SF-36) score measure: dietary intake measure: Physical activity measure: fear for hypoglycaemia measure: fear for hyperglycaemia measure: symptoms of depression measure: symptoms of anxiety measure: user-friendliness of CGM measure: user-friendliness of CGM compared to oral glucose tolerance test (OGTT) measure: duration of breastfeeding measure: rate of hypercholesterolemia measure: night glucose time in range between 70-180mg/dl measure: day glucose time in range between 70-180mg/dl measure: day glucose time in range <70mg/dl measure: night glucose time in range <70mg/dl measure: night glucose time in range >180mg/dl measure: day glucose time in range >180mg/dl sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OLV Aalst-Asse city: Aalst state: Oost-Vlaanderen zip: 9300 country: Belgium name: Inge Van Pottelbergh, MD PhD role: CONTACT lat: 50.93604 lon: 4.0355 facility: UZA city: Antwerp country: Belgium name: Niels Bochanen role: CONTACT lat: 51.21989 lon: 4.40346 facility: ZNA Antwerpen city: Antwerp country: Belgium name: Astrid Morrens, MD role: CONTACT lat: 51.21989 lon: 4.40346 facility: Imelda Bonheiden city: Bonheiden zip: 2820 country: Belgium name: Da Hae Lee, MD role: CONTACT lat: 51.02261 lon: 4.54714 facility: AZ St Jan Brugge city: Brugge zip: 8000 country: Belgium name: Sara Vandewalle role: CONTACT lat: 51.20892 lon: 3.22424 facility: Erasme city: Brussel country: Belgium name: Tiphaine Carton role: CONTACT lat: 50.85045 lon: 4.34878 facility: UCL city: Brussel country: Belgium name: Fabian Lurquin role: CONTACT lat: 50.85045 lon: 4.34878 facility: UZ Gent city: Gent zip: 9000 country: Belgium name: Joke Marlier, MD role: CONTACT lat: 51.05 lon: 3.71667 facility: AZ St Lucas Gent city: Gent country: Belgium name: Inge Van Boxelaer role: CONTACT lat: 51.05 lon: 3.71667 facility: AZ Groeninge Kortrijk city: Kortrijk zip: 8510 country: Belgium name: Ellen Heyns, MD role: CONTACT lat: 50.82803 lon: 3.26487 facility: UZ Leuven city: Leuven country: Belgium name: Katrien Benhalima, MD PhD role: CONTACT email: katrien.benhalima@uzleuven.be lat: 50.87959 lon: 4.70093 facility: CHU de Liège city: Liège country: Belgium name: JC Philips role: CONTACT lat: 50.63373 lon: 5.56749 facility: AZ St Maarten Mechelen city: Mechelen country: Belgium name: Kathleen Bollaerts role: CONTACT lat: 51.02574 lon: 4.47762 facility: Centre Hospitalier Mouscron city: Mouscron country: Belgium name: Philippe Oriot role: CONTACT lat: 50.74497 lon: 3.20639 facility: AZ Delta Roeselare city: Roeselare country: Belgium name: Xavier-Philippe Aers role: CONTACT lat: 50.94653 lon: 3.12269 facility: Vitaz city: Sint-Niklaas country: Belgium name: Peter Coremans role: CONTACT lat: 51.16509 lon: 4.1437 facility: AZ Turnhout city: Turnhout country: Belgium name: Joke Cuypers, MD role: CONTACT lat: 51.32254 lon: 4.94471 hasResults: False

 nctId: NCT06310343 id: 304993 briefTitle: ADAs to Alemtuzumab overallStatus: ACTIVE_NOT_RECRUITING date: 2022-04-25 date: 2025-11-30 date: 2025-11-30 date: 2024-03-15 date: 2024-03-15 name: Queen Mary University of London class: OTHER briefSummary: The main aim is to quantify the changes in alemtuzumab antibody-anti-alemtuzumab over a 24 months period conditions: Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 15 type: ACTUAL name: Alemtuzumab measure: To quantify the longitudinal changes in alemtuzumab ADAs measure: 1. Relative occurrence of infusion-related reactions based on high alemtuzumab ADA levels prior to course 2. measure: 2. Relative change in lymphocyte counts after the second infusion of alemtuzumab in ADA positive patients to assess the health economic impact of infusion-related reactions. measure: 3. Relative change in relapses or EDSS score based on alemtuzumab ADA levels to assess the health economic impact of disease activity. measure: 4. Relative change in relapses or EDSS score based on alemtuzumab ADA levels measure: 5. Relative change in T2 lesion number or Gd-enhancing lesions, and serum NfL based on alemtuzumab ADA levels to assess the health economic impact of disease activity. sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Barts Health NHS Trust city: London state: Second Floor Neurophys Dept country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06310330 id: 2019/1059 briefTitle: TRUST-ACE - Anticancer-treatment Cardiotoxicity Identification by Echocardiography acronym: TRUST-ACE overallStatus: RECRUITING date: 2024-03-08 date: 2026-12-31 date: 2026-12-31 date: 2024-03-15 date: 2024-03-20 name: Norwegian University of Science and Technology class: OTHER name: St. Olavs Hospital briefSummary: TRUST-ACE will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomised design in follow-up of breast-cancer patients with respect to identification of cancer treatment related cardiac dysfunction (CTRCD).

Secondly, the study will evaluate whether novel tools used to improve standardization of recordings as well as automated measurements of central measurements, e.g. ejection fraction (EF) and global longitudinal strain (GLS) can improve the precision of echocardiography in daily clinical practice. conditions: Breast Neoplasm Malignant Primary studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomization 1:1 to two different modes of follow-up primaryPurpose: DIAGNOSTIC masking: NONE maskingDescription: No masking count: 250 type: ESTIMATED name: Comprehensive echocardiographic follow-up name: Simplified echocardiographic follow-up measure: Proportion of patients correctly classified with cancer therapy related cardiac dysfunction (CTRCD) measure: Proportion of patients misclassified as having/not having cancer therapy related cardiac dysfunction (CTRCD) measure: Risk classification measure: Risk classification measure: Test-retest variability, systolic left ventricular size and function measure: Test-retest variability, systolic left ventricular size and function measure: Test-retest variability, diastolic left ventricular size and function measure: Test-retest variability, diastolic left ventricular size and function measure: Test-retest variability, right ventricular size and function measure: Test-retest variability, right ventricular size and function measure: Time consumption measure: Time consumption sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Olavs hospital status: RECRUITING city: Trondheim zip: 7491 country: Norway name: Rune Wiseth, MD, PhD role: CONTACT phone: 92247845 phoneExt: 47 email: rune.wiseth@stolav.no lat: 63.43049 lon: 10.39506 hasResults: False

 nctId: NCT06310317 id: CNR-IRIB-PRO-2024-003 briefTitle: Applied Behavior Analysis With Technologies overallStatus: RECRUITING date: 2023-09-01 date: 2025-01-31 date: 2025-01-31 date: 2024-03-15 date: 2024-03-15 name: Istituto per la Ricerca e l'Innovazione Biomedica class: OTHER briefSummary: Applied Behavior Analysis (ABA) is a therapeutic approach for autism that is based on the principles of behavioral theory, learning, and positive reinforcement. Current research shows that early and intensive ABA intervention is effective in reducing dysfunctional behaviors and promoting learning and enactment of socially appropriate behaviors.

In this context, new approaches that attempt to integrate advanced technologies can play a key role. This experimental protocol aims to test whether the use of advanced technologies, such as tablets, as part of an intervention for a group of children with autism spectrum disorder (ASD) is more effective than the traditional approach implemented in a control group of children with ASD. The experimental protocol is aimed at enhancing cognitive skills, increasing new skills and acquiring functional/adaptive behaviors. conditions: Autism conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Applied Behavior Analysis protocol name: Traditional intervention measure: Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) sex: ALL minimumAge: 5 Years maximumAge: 12 Years stdAges: CHILD facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) status: RECRUITING city: Messina zip: 98164 country: Italy name: Flavia Marino role: CONTACT phone: +393395798263 email: flavia.marino@irib.cnr.it name: Maria Valeria Maiorana role: CONTACT phone: +393285856656 email: mariavaleria.maiorana@irib.cnr.it name: Flavia Marino role: PRINCIPAL_INVESTIGATOR name: Giovanni Pioggia role: SUB_INVESTIGATOR name: Paola Chilà role: SUB_INVESTIGATOR name: Roberta Minutoli role: SUB_INVESTIGATOR name: Noemi Vetrano role: SUB_INVESTIGATOR name: Chiara Failla role: SUB_INVESTIGATOR name: Germana Doria role: SUB_INVESTIGATOR name: Ileana Scarcella role: SUB_INVESTIGATOR name: Cinzia Grasso role: SUB_INVESTIGATOR name: Mariaelena Franchina role: SUB_INVESTIGATOR lat: 38.19394 lon: 15.55256 hasResults: False

 nctId: NCT06310304 id: INCB18424-153 briefTitle: A Study to Evaluate the Relative Bioavailability of Ruxolitinib Extended Release (XR) Tablets Compared With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants. overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-26 date: 2024-04-16 date: 2024-05-15 date: 2024-03-15 date: 2024-04-10 name: Incyte Corporation class: INDUSTRY briefSummary: This study is conducted to determine the Relative Bioavailability of Ruxolitinib XR Tablets Compared With Ruxolitinib IR Tablets Administered Orally in Healthy Participants. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 24 type: ACTUAL name: Ruxolitinib IR name: Ruxolitinib XR measure: INCB018424 pharmacokinetic (PK) in Plasma measure: Number of participants with Treatment Emergent Adverse Events (TEAEs) measure: Additional INCB018424 pharmacokinetic (PK) in Plasma sex: ALL minimumAge: 19 Years maximumAge: 55 Years stdAges: ADULT facility: Celerion, Inc city: Lincoln state: Nebraska zip: 68502 country: United States lat: 40.8 lon: -96.66696 hasResults: False

 nctId: NCT06310291 id: GLU001 briefTitle: VTP-1000 in Adults With Celiac Disease overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-08 date: 2025-08 date: 2024-03-15 date: 2024-03-15 name: Barinthus Biotherapeutics class: INDUSTRY briefSummary: GLU001 is a first-in-human clinical trial to assess the safety and tolerability of VTP-1000 for adults with celiac disease. This trial will assess VTP-1000 at various dose levels compared to placebo in a single ascending dose (SAD) and multiple ascending dose (MAD) format. Participants will be followed for a short period of time to assess the impact of VTP-1000 on their immune system (Adverse events, reactions in the blood, and physical exam differences). Participants enrolled in the MAD portion of the trial will undergo a gluten challenge to assess the impact exposure to gluten has on participants after administration of VTP-1000. conditions: Celiac Disease studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The Single Ascending Dose part of the trial contains a placebo controlled randomized 4+2 design, where four participants will receive active IMP and two placebo. The Multiple Ascending Dose is a standard sequential design primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: VTP-1000 name: Matched Placebo measure: Treatment Emergent Adverse Events, Serious Adverse Events and Adverse Events of Special Interest (AESIs) measure: Changes from baseline and clinically significant abnormalities in standard Clinical Chemistry laboratory safety parameters measure: Changes from baseline and clinically significant abnormalities in standard Coagulation laboratory safety parameters measure: Changes from baseline and clinically significant abnormalities in standard hematology laboratory safety parameters measure: Changes from baseline and clinically significant abnormalities in standard urinalysis laboratory safety parameters measure: Changes from baseline and clinically significant abnormalities 12-lead electrocardiogram (ECG) parameters measure: Changes from baseline and clinically significant abnormalities in vital signs measure: Number of participants with changes from baseline in anti-tissue transglutaminase (anti-tTG) immunoglobulin A (IgA) antibodies measure: Changes in physical examination findings measure: PART A SAD:Maximum concentration in plasma (Cmax) rapamycin component measure: PART A SAD: Time corresponding to Cmax (Tmax) of rapamycin component measure: AUC from time 0 to last quantifiable concentration (AUC0-t) of rapamycin component measure: AUC extrapolated to infinity (AUC0-∞)of rapamycin component measure: Half-life of rapamycin component measure: Clearance of rapamycin component measure: Volume of distribution of rapamycin component measure: Part B MAD:Maximum concentration in plasma (Cmax) rapamycin component measure: Part B MAD:Time corresponding to Cmax (Tmax) of rapamycin component measure: Part B MAD:AUC from time 0 to last quantifiable concentration (AUC0-t) of rapamycin component measure: Part B MAD:AUC extrapolated to infinity (AUC0-∞)of rapamycin component measure: Part B MAD: Half-life of rapamycin component measure: Part B MAD: Clearance of rapamycin component measure: Gluten Antigen-specific T Cell Responses - Enzyme linked immunospot (ELISpot) measure: Gluten Antigen-specific T Cell Responses - Intracellular cytokine staining (ICS) measure: T cell receptor (TCR) sequencing measure: Serum Cytokine Concentrations measure: Cytokine Whole Blood Stimulation sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06310278 id: 1030312 briefTitle: Ossiview Normative Mobility Data Collection Protocol overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-31 date: 2024-10-31 date: 2024-03-15 date: 2024-03-15 name: Audioptics Medical Incorporated class: INDUSTRY briefSummary: The goal of this observational study is to learn about the sound-induced vibration level of certain structures in the middle ear in the normal-hearing population. The targeted structures are part of a chain of structures responsible for conducting sound within the auditory system and so their ability to vibrate normally in response to sound is relevant to the diagnosis of conductive hearing loss.

The main questions the study aims to answer are:

* What are the mean and variance of the normal sound-induced vibration level at two anatomical locations, the umbo of the malleus and the tip of the incus?
* Are there any significant differences in these vibrational responses associated with sex or age?

Participants will have their ossicular mobility measured with an investigational medical device that sends light into the middle ear and measures the motion-induced phase shift on light reflected from the target structures when a sound stimulus is presented. Standard hearing tests including audiometry and tympanometry will also be performed to confirm the normal hearing status of participants. conditions: Conductive Hearing Loss, Middle Ear studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Ossicular mobility measurement measure: Umbo mobility measure: Incus mobility measure: Dependence on age and sex sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06310265 id: TABED 1-24-21 briefTitle: Our Anesthesia Experiment Applied to Child Earthquake Victims in the February 6, 2023 Earthquake overallStatus: RECRUITING date: 2024-03-12 date: 2024-04-05 date: 2024-04-22 date: 2024-03-15 date: 2024-04-19 name: Ankara City Hospital Bilkent class: OTHER briefSummary: The study aimed to investigate anesthesia management of pediatric patients in the Ankara Bilkent City Hospital during the earthquake disaster of February 6. conditions: Earthquake conditions: Crush Injury conditions: Anesthesia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED name: Retrospective observational study measure: The anesthesia management under pediatric earthquake victims sex: ALL minimumAge: 30 Days maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Ankara Bilkent City Hospital status: RECRUITING city: Ankara zip: 06800 country: Turkey name: Sengul Ozmert role: CONTACT phone: +905323861201 email: sengulozmert@yahoo.com.tr lat: 39.91987 lon: 32.85427 facility: Ankara Bilkent City Hospital,Department Of Anesthesiology and Reanimation status: RECRUITING city: Ankara state: Çankaya zip: 06800 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06310252 id: PRO_010-2023 briefTitle: Safety and Efficacy of an Intrastromal Transform Corneal Allograft (TCA) for Presbyopia Correction - Long Term Follow-up overallStatus: RECRUITING date: 2024-02-13 date: 2024-06 date: 2024-09 date: 2024-03-15 date: 2024-03-15 name: Allotex, Inc. class: INDUSTRY briefSummary: The objective of this clinical study is to evaluate the long term safety and effectiveness of intrastromal implantation of the Allotex TransForm corneal allograft (TCA) for providing near vision in presbyopic subjects.

A maximum of 101 eyes of qualified and consented subjects will undergo long term follow-up after instrastromal implantation of the TCA for presbyopia. conditions: Presbyopia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 101 type: ESTIMATED name: Opthalmic assessments measure: An exploratory data collection project with no primary safety or effectiveness endpoints. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Gemini - Oční klinika Zlín status: RECRUITING city: Zlín zip: 760 01 country: Czechia name: Stodůlka role: CONTACT phone: +420 577 202 202 email: info@gemini.cz lat: 49.22645 lon: 17.67065 facility: Wellington Eye Clinic status: NOT_YET_RECRUITING city: Dublin zip: D18 T8P3 country: Ireland lat: 53.33306 lon: -6.24889 facility: Medipol University status: RECRUITING city: Istanbul zip: 34214 country: Turkey name: Tanriverdi role: CONTACT phone: +904447044 email: international@medipol.com.tr lat: 41.01384 lon: 28.94966 facility: Centre For Sight status: NOT_YET_RECRUITING city: East Grinstead zip: RH149 4RH country: United Kingdom lat: 51.12382 lon: -0.0061 hasResults: False

 nctId: NCT06310239 id: WRNMMC-2023-0434 id: 67407 type: OTHER_GRANT domain: PRORP briefTitle: Microbiome Population Adaptation Study acronym: OLIMPAS overallStatus: RECRUITING date: 2023-12-01 date: 2027-11-30 date: 2029-11-30 date: 2024-03-15 date: 2024-03-15 name: Walter Reed National Military Medical Center class: FED briefSummary: The investigators will accomplish our research aims by collecting cutaneous microbiome samples from 50 persons that have undergone the Osseointegration (OI) surgery at eight timepoints, prospectively. The investigators will also collect control samples to correct for turnovers in species compositions that may naturally occur and to compare the residual limb microbiome to the sound contralateral limb. The investigators will sequence the bacterial community using universal bacterial primers. Using these sequences, The investigators will borrow from ecological theory and calculate the alpha and beta diversity. The alpha diversity will determine the species and abundance of each species that are present, while the beata diversity will allow us to compare how species assemblages and frequencies change between time points. Then, the investigators will take a phylogenetic modeling approach to determine if particular species assemblages correlate with rates of wound healing. The investigators will construct phylogenies from the sequences at the different time points and "paint" the rate of wound healing along the phylogeny (e.g., improved, stagnated, worsened). Using Akaike and Bayesian information criterion, the investigators can determine which phylogenetic model best explains the patterns the investigators see across patients. Lastly, the investigators will quantify soft tissue stability and health and correlate this with the homeostasis of the microbial community. Specifically, the investigators will determine if redundant soft tissue leads to altered microbial communities that can impact the rate of wound healing. Finally, the investigators will further stratify these data to compare microbial communities between the sexes, upper versus lower limbs, and proximal versus distal amputations. This work will allow us to better treat infections after OI surgery and can shed light on wound healing process so that the investigators can better treat limb loss patients and the military community as a whole. conditions: Amputation With Osseointegration studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Collection of biologic samples and data measure: Determine if OI surgery causes changes in the microbiome community using phylogenies measure: Determine if changes in the microbiome community predicts wound healing using phylogenetic comparative methods measure: Quantify soft tissue health using a modified Holger Score (0 = healthy soft issue and 6 = unhealthy soft tissue) to phylogenetically correlate this with microbiome homeostasis. measure: Floral profiles measure: Floral colonization measure: Clinical guidelines measure: Surgical site questionnaire measure: Post-OI hygiene guidelines measure: Soft tissue stability guidelines measure: Holger score validation sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Orhopaedic Surgery Service, Walter Reed National Military Medical Center, status: RECRUITING city: Bethesda state: Maryland zip: 20889 country: United States name: Angelica M Melendez-Munoz role: CONTACT phone: 202-549-3229 email: angelica.m.melendez-munoz.ctr@health.mil name: Toby L Perkins role: CONTACT phone: 240-308-0548 email: toby.l.perkins.ctr@health.mil name: Ean R Saberski, MD role: PRINCIPAL_INVESTIGATOR lat: 38.98067 lon: -77.10026 hasResults: False

 nctId: NCT06310226 id: 23-000347 briefTitle: Phenotyping Response to Spinal Cord Stimulation in Chronic Low Back Pain overallStatus: RECRUITING date: 2024-04-01 date: 2025-03-01 date: 2025-03-01 date: 2024-03-15 date: 2024-03-15 name: University of California, Los Angeles class: OTHER briefSummary: Chronic low back pain (CLBP) is a debilitating condition and costly to treat. Long-term drug treatment often fails due to habituation, breakthrough of pain, or adverse effects of drug treatment. Opioid use to manage this pain has contributed to the opioid epidemic. Spinal cord stimulators have emerged as a promising treatment and reduces reliance on drugs. However, response to spinal cord stimulation (SCS) is unpredictable. It is difficult to predict which patients will respond positively to SCS because the physiological mechanism for treatment responsiveness is unclear. Therefore, the aim of this study is to investigate how spinal cord stimulators affect functional measures in patients with CLBP, including functional MRI, neurophysiology, gait analysis, and questionnaires. The results of this study can lead to the widespread adoption of spinal cord stimulators as a safe and effective therapy for CLBP, reducing the reliance on opioids and mitigating the opioid epidemic's impact. conditions: Chronic Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ESTIMATED name: Epidural electrical spinal cord stimulator measure: Detection of brain connectivity using functional MRI measure: Detection of brain waves using electroencephalography (EEG) measure: Neurological gait kinematics assessment measure: Neurophysiological functional assessment using somatosensory evoked potential (SSEP) measure: Neurophysiological functional assessment using pain-related evoked potential (PREP) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, Los Angeles status: RECRUITING city: Los Angeles state: California zip: 90095 country: United States name: Chau role: CONTACT lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06310213 id: 17368 briefTitle: Non-Invasive Pressure Monitor for Neonates & Infants at Risk of Developing Hydrocephalus overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-06-01 date: 2028-07-01 date: 2024-03-15 date: 2024-03-15 name: Indiana University class: OTHER briefSummary: The goal of this clinical trial is to test a modified smart soft contact lens in neonates and infants at risk of developing hydrocephalus. The main questions it aims to answer are:

* Can the device distinguish between intracranial pressure variations in neonates and infants diagnosed with hydrocephalus and those without
* Can the device compare pressure dynamics between pre- and post-operative periods in neonates and infants who undergo surgical treatments Participants will undergo standard of care evaluations for hydrocephalus (anterior fontanelle assessment and head circumference measurement) and wear the device during standard of care evaluation; pre- and post- ventricular reservoir taps, as applicable; and/or pre- and post-operatively, as applicable. conditions: Hydrocephalus in Infants studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Aim 1: Comparison of neonates and infants with hydrocephalus and without Aim 2: Using smart soft contact lens (SSCL) for pre- and post-operative measurements on neonates and/or infants managed operatively (shunt placement) Aim 3: Direct validation by comparing SSCL to external ventricular drain (EVD) intracranial pressure (ICP) monitoring Aim 4: Using SSCL for pre- and post- reservoir tap measurements on neonates and/or infants managed operatively (reservoir placement) Aim 1: 10 patients per arm, two arms Aim 2: 5-10 patients, one arm Aim 3: 5-10 patients, one arm Aim 4: 5-10 patients, one arm primaryPurpose: SCREENING masking: NONE count: 25 type: ESTIMATED name: Non-Invasive Pressure Monitor measure: Efficacy of modified smart soft contact lens evaluation of external intracranial pressure sex: ALL minimumAge: 0 Months maximumAge: 12 Months stdAges: CHILD facility: Riley Hospital for Children city: Indianapolis state: Indiana zip: 46202 country: United States name: Jignesh Talior, MD role: CONTACT phone: 317-944-6201 lat: 39.76838 lon: -86.15804 hasResults: False

 nctId: NCT06310200 id: IRB-2023-398 briefTitle: Sphenopalatine Ganglion Block and Cold Induced Headaches overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-07-01 date: 2024-03-15 date: 2024-03-15 name: Wright State University class: OTHER briefSummary: The primary objective of this study is to determine if a sphenopalatine ganglion (SPG) block, performed through intranasal atomization of 4% lidocaine, is able to prevent cold induced cephalgia ("Brain Freeze"). Secondary objectives will be to determine the degree of decreased pain/duration of brain freeze after sphenopalatine ganglion block conditions: Cold Induced Headache conditions: Brain Freeze conditions: Cold Induced Cephalgia conditions: Headache studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: All besides PI whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Lidocaine Topical 4% Topical Solution name: Bitrex name: normal saline measure: Does sphenopalatine ganglion (SPG) block prevent cold induced cephalgia measure: Degree of pain measure: Duration of brain freeze measure: Time to onset of headache sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06310187 id: STUDY00023967 id: U54DA058271-01 type: NIH link: https://reporter.nih.gov/quickSearch/U54DA058271-01 briefTitle: Little Cigar Oxidants overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2029-08 date: 2029-08 date: 2024-03-15 date: 2024-03-15 name: Milton S. Hershey Medical Center class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: Determine the effects of little cigars on human exposure to tobacco smoke oxidants. In a balanced randomized cross-over study design in cigarette smokers, subjects will be assigned to 6 exposure groups. These include a high oxidant unflavored little cigar exposure condition, a low oxidant unflavored little cigar exposure condition, a high oxidant flavored exposure condition, a low oxidant flavored exposure little cigar exposure condition, their usual cigarette, and a control condition (unlit little cigar). Following the smoking of each product, exhaled breath condensate samples will be collected at baseline, 30, 60, 90, 120 and 150 minutes. Samples will be analyzed for levels of oxidant markers including hydrogen peroxide, 8-isoprostanes, and C-reactive protein, as well as nicotine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) and N'-nitrosonornicotine (NNN). conditions: Tobacco Use conditions: Oxidative Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Williams Design for Cross over-trials with a 6-period 6-treatment cross-over design in 36 healthy daily cigarette smokers. primaryPurpose: BASIC_SCIENCE masking: NONE count: 50 type: ESTIMATED name: High Oxidant Unflavored Little Cigar - Group A name: Low Oxidant Unflavored Little Cigar - Group B name: High Oxidant Flavored Little Cigar - Group C name: Low Oxidant Flavored Little Cigar - Group D name: Usual Cigarette - Group E name: Unlit Little Cigar - Group F measure: Hydrogen Peroxide Concentration in Exhaled Breath Condensate measure: Hydrogen Peroxide Concentration in Exhaled Breath Condensate measure: Hydrogen Peroxide Concentration in Exhaled Breath Condensate measure: Hydrogen Peroxide Concentration in Exhaled Breath Condensate measure: 8-isoprostanes Concentration in Exhaled Breath Condensate measure: 8-isoprostanes Concentration in Exhaled Breath Condensate measure: 8-isoprostanes Concentration in Exhaled Breath Condensate measure: 8-isoprostanes Concentration in Exhaled Breath Condensate measure: C-reactive Protein Concentration in Exhaled Breath Condensate measure: C-reactive Protein Concentration in Exhaled Breath Condensate measure: C-reactive Protein Concentration in Exhaled Breath Condensate measure: C-reactive Protein Concentration in Exhaled Breath Condensate measure: Nicotine Concentration in Exhaled Breath Condensate measure: Nicotine Concentration in Exhaled Breath Condensate measure: Nicotine Concentration in Exhaled Breath Condensate measure: Nicotine Concentration in Exhaled Breath Condensate measure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate measure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate measure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate measure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate measure: N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate measure: N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate measure: N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate measure: N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06310174 id: IRB00362883 briefTitle: Study Examining the Effect of a Novel Cannulation Knife on User Satisfaction and Common Central Venous Catheter Insertion Complications acronym: SCAD overallStatus: RECRUITING date: 2023-12-22 date: 2026-03 date: 2027-05 date: 2024-03-15 date: 2024-03-15 name: Johns Hopkins University class: OTHER briefSummary: The purpose of this study is to assess user satisfaction and the frequency of common central venous catheter insertion complications when using a novel cannulation knife. conditions: Central Venous Catheter Exit Site Infection studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 144 type: ESTIMATED measure: User satisfaction with the new cannulation knife for CVC insertion. measure: Frequency of skin incision revisions. measure: Frequency of procedures being aborted and restarted. measure: Frequency of reverting to use of the scalpel normally used to make the incision. measure: Presence of a clean, dry dressing. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins Hospital status: RECRUITING city: Baltimore state: Maryland zip: 21287 country: United States name: Lisa Fornaresio, PhD role: CONTACT phone: 443-927-3984 email: lisa.fornaresio@jhmi.edu name: Zyriah Robinson role: CONTACT phone: 443.927.3983 email: zyriah.robinson@jhmi.edu name: James Gammie, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06310161 id: 855161 briefTitle: Light Therapy in End Stage Kidney Disease overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2024-12-01 date: 2025-03-01 date: 2024-03-15 date: 2024-04-23 name: University of Pennsylvania class: OTHER briefSummary: The goal of this clinical trial is to test light therapy in patients with end stage kidney disease who are receiving hemodialysis. The main aim is to determine if light therapy decreases fatigue severity. Participants will receive light therapy using special glasses for one hour during the dialysis sessions for four weeks of treatment. conditions: End Stage Renal Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Bright light name: Dim Light measure: Fatigue Severity Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06310148 id: UW 24-019 briefTitle: Evaluation of the Chronic Disease Co-Care Pilot Scheme overallStatus: RECRUITING date: 2024-01-18 date: 2025-07-01 date: 2026-12-31 date: 2024-03-15 date: 2024-03-22 name: The University of Hong Kong class: OTHER name: Health and Medical Research Fund name: Primary Healthcare Office, Hong Kong briefSummary: The Chronic Disease Co-Care (CDCC) Pilot Scheme is initiated for early screening and management of people with hypertension (HT), pre-diabetes mellitus (pre-DM) and diabetes mellitus (DM) in Hong Kong. This study will evaluate the quality of care, feasibility, acceptability, effectiveness and cost-effectiveness of the Scheme.

This is a 12-month cohort study among the District Health Centre (DHC) or DHC Express, healthcare providers, CDCC participants and a comparison group of 1,886 non-participants. All the person-in charge, 2 family doctors and 1 of each allied health provider from each DHC/DHC Express will be administered with the questionnaires on quality of care and costing. All CDCC participants will be included in subject characteristics, among which a convenience sample of 548 will complete a telephone survey on experience, enablement and satisfaction of the CDCC Pilot Scheme. The health outcomes of 1,886 CDCC participants and 1,886 non-participants will be compared for evaluation of effectiveness and cost-effectiveness.

Participant characteristics, enablement, compliance to the standards of care, and costing of CDCC Pilot Scheme will be summarized using descriptive statistics. Differences in the proportion of patients meeting treatment targeted for HT, pre-DM and DM after 12 months will be compared by chi-squared test and logistic regressions. The incremental cost-effectiveness ratio will be evaluated by comparing with the World Health Organization (WHO) threshold. This study will inform future healthcare planning and policy for manpower and resource allocation. conditions: Diabetes Mellitus, Type 2 conditions: Hypertension conditions: Chronic Disease conditions: Disease Management conditions: Primary Healthcare studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 3772 type: ESTIMATED name: The Chronic Disease Co-Care (CDCC) Pilot Scheme measure: Characteristics of the Chronic Disease Co-Care (CDCC) participants measure: Healthcare providers' adherence to care standards on the evaluation framework by the quality of care questionnaire measure: Enablement of CDCC participants by the Chinese Patient Enablement Instrument measure: Effectiveness of the CDCC Pilot Scheme on disease control for pre-diabetes mellitus (pre-DM) and DM in percent of Glycated Hemoglobin (HbA1c) and hypertension (HT) in millimeter of mercury of systolic blood pressure (SBP)/diastolic blood pressure (DBP) measure: The additional costs for delivering the CDCC Pilot Scheme by the costing questionnaire measure: The cost-effectiveness for delivering the CDCC Pilot Scheme on the incremental cost-effectiveness ratio measure: Experience and satisfaction of CDCC participants by the experience and enablement questionnaire measure: Number of attendance to doctor consultation on times in comparison groups measure: Rate of diagnosis of HT and/or DM on dichotomous yes/no response in comparison groups measure: Changes in mean HbA1c/FPG in percent between two groups measure: Changes in mean SBP and DBP in millimeter of mercury between two groups measure: Changes in mean of HbA1c in percent between two groups measure: Changes in BMI in kilogram per square metre between two groups measure: Changes in the rate of smoking cessation and rate of alcohol abstinence between two groups by the Health Risk Factor Assessment measure: The predicted 10-year cardiovascular disease (CVD) risk between two groups measure: Amount of direct medical costs between two groups sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jockey Club Building for Interdisciplinary Research 5 Sassoon Road, Pok Fu Lam, HONG KONG status: RECRUITING city: Hong Kong country: Hong Kong name: Eric Yuk Fai Wan role: CONTACT phone: 852 28315057 phoneExt: 852 28147475 email: yfwan@hku.hk lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06310135 id: STUDY-23-00816 briefTitle: Filtered Eyewear to Prevent Light-induced Melatonin Suppression - Aim 1 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-03-15 date: 2024-03-15 name: Icahn School of Medicine at Mount Sinai class: OTHER briefSummary: The aim of this study is to determine the relative effectiveness of monocular and binocular light exposures, with and without selective blue-blocking filtering, on nocturnal melatonin suppression, subjective sleepiness, and visual performance of night shift workers. conditions: Sleep Quality studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Filtered Eyewear name: Unfiltered Eyewear name: No Filters measure: Melatonin Levels measure: Karolinska Sleepiness scale to measure Subjective Sleepiness measure: Numerical Verification Task (NVT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Light and Health Research Center city: Menands state: New York zip: 12204 country: United States name: Barbara Plitnick, RN role: CONTACT phone: 518-242-4603 email: barbara.plitnick@mountsinai.org name: Mariana Figueiro role: PRINCIPAL_INVESTIGATOR lat: 42.69202 lon: -73.72456 hasResults: False

 nctId: NCT06310122 id: ESWT on planter fascitis briefTitle: Effect of Extracorporeal Shockwave Therapy on Gait Parameters in Patients With Planter Fascitis overallStatus: NOT_YET_RECRUITING date: 2024-03-12 date: 2024-09-01 date: 2025-03-30 date: 2024-03-15 date: 2024-03-15 name: Cairo University class: OTHER briefSummary: The purpose of this study is :

* to determine the effect of extracorporeal shockwave on pain intensity in patients with plantar fasciitis.
* to determine the effect of extracorporeal shockwave on foot function in patients with plantar fasciitis.
* to determine the effect of extracorporeal shockwave on gait parameters in patients with plantar fasciitis conditions: Plantar Fascitis conditions: Extracorporeal Shockwave Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups : group (A) , group (B) One of them will receive traditional treatment ( ultra sound , exercises) Other one will recieve extracorporeal shockwave therapy and traditional treatment also primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 52 type: ESTIMATED name: Extracorporeal shockwave therapy name: ultrasound measure: Stride length mean distance measured by (meter) measure: stride time mean time measured by (second) measure: speed mean distance/ time measured by (meter/second) measure: cadence mean number of steps /times. measure: pain intensity level. measure: Foot function sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06310109 id: 2358_OPBG 2020 briefTitle: Effect of Pediatric Intensive Care Unit Diaries on PICS-p acronym: PICS-p overallStatus: RECRUITING date: 2021-07-14 date: 2024-05-31 date: 2024-10-31 date: 2024-03-15 date: 2024-03-15 name: Bambino Gesù Children's Hospital IRCCS class: OTHER name: Ministry of Health, Italy briefSummary: When children become very sick and need to stay in a Pediatric Intensive Care Unit (PICU), it can have a big impact on their recovery and their family's well-being. Sometimes kids and their families feel worried or sad even after they leave the hospital. This can have an impact on the quality of their life after hospital discharge.

To help understand and improve these experiences, the investigators want to study the "PICU diaries." These are journals that families and hospital staff can write in during the child's time in the hospital. Parents, other visitors and healthcare professionals can share thoughts, experiences, and even drawings or photos related to the child's admission. The content is a narrative account of what happens during the child's hospital stay, for the family to take home at PICU discharge.

The investigators believe that writing in these diaries might help children and their families feel better after leaving the hospital. It might help kids feel less worried or sad, and it might also help their parents or caregivers feel better too.

The study will include children who have been in the PICU and their families. Some families will receive these special diaries to use during their time in the hospital, while others won't. We'll then see how everyone feels after they leave the hospital and compare the two groups to see if the diaries make a difference.

The investigators hope that by understanding how these diaries can help, healthcare professionals can make hospital experiences better for everyone involved. conditions: Post Intensive Care Syndrome conditions: Narrative Medicine conditions: Post Traumatic Stress Disorder conditions: Anxiety conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 110 type: ESTIMATED name: PICU diary measure: Parent's Post Traumatic Stress Disease (PTSD) measure: Parent's Anxiety measure: Child's Strengths and difficulties measure: Child's Post Traumatic Stress Disease (PTSD) measure: Child's Anxiety measure: Child's Depression measure: Satisfaction with PICU care measure: Patient's Quality of Life sex: ALL maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: Bambino Gesù Children's Hospital IRCCS status: RECRUITING city: Rome zip: 00165 country: Italy name: Orsola Gawronski, PhD role: CONTACT lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06310096 id: E-59394181-604.01-79277 briefTitle: Role of Thoracolumbar Fascia Stretching on Pain Parameters With Non-Specific Chronic Low Back Pain overallStatus: RECRUITING date: 2024-01-01 date: 2024-03-11 date: 2024-03-11 date: 2024-03-15 date: 2024-03-15 name: Atılım University class: OTHER name: Kirsehir Ahi Evran Universitesi briefSummary: Role of Thoracolumbar Fascia Stretching on Pain Parameters with Non-Specific Chronic Low Back Pain conditions: Pain conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: TLF fascial stretching exercise name: conventional physiotherapy program. measure: Pain threshold measure: Temporal summation measure: NRS(Numerical rating scales) measure: Pain Sensitivity Scale (PSS) measure: Brief Pain Inventory (BPI) sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Atılım University status: RECRUITING city: Ankara country: Turkey name: Naime Uluğ, PhD. role: CONTACT phone: +905365434409 email: naime.ulug@atilim.edu.tr lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06310083 id: SMR for Turbinate Hypertrophy briefTitle: Endoscopic Submucosal Resection Turbinoplasty VS Turbinectomy overallStatus: COMPLETED date: 2023-02-01 date: 2024-01-31 date: 2024-01-31 date: 2024-03-15 date: 2024-03-15 name: Ahmed Nabil Selim class: OTHER briefSummary: The aim of our study is to compare endoscopic submucosal resection Turbinoplasty and partial inferior turbinectomy regarding clinical and radiological evaluation and its possible complications in the treatment of Chronic inferior turbinate hypertrophy. conditions: Turbinate; Hypertrophy Mucous Membrane studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A total of 40 patients were enrolled in the study. The patients were randomly classified into two groups, with 20 in each group.

Group A (study group): who applied for Endoscopic submucosal resection Turbinoplasty.

Group B (control group): Who applied for partial inferior turbinectomy. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The surgeons performed the nasal surgery and evaluating postoperative measurable outcomes was blinded about cases who were subjected to Endoscopic submucosal resection Turbinoplasty whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Submucosal Resection Turbinoplasty Versus Partial Inferior Turbinectomy measure: Nasal Obstruction measure: Nasal Discharge measure: Crustations measure: intra operative blood loss measure: Duration of operation (Minutes ) measure: Hyposmia measure: Size Of Anterior part of Turbinate measure: Size Of Posterior part of Turbinate measure: Space of Anterior nasal Cavity measure: Space of posterior nasal Cavity sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Al-Azhar University Hospital of Assiut city: Assiut zip: 17511 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06310070 id: IRB-23-1965 briefTitle: 3D Printed Personalized Ostomy Appliance acronym: 3DPPOA overallStatus: NOT_YET_RECRUITING date: 2025-03-05 date: 2025-03-05 date: 2025-06-05 date: 2024-03-13 date: 2024-03-21 name: Carilion Clinic class: OTHER name: Virginia Polytechnic Institute and State University briefSummary: The goal of this clinical trial is to learn about the effectiveness of using a 3D scan for a personal ostomy appliance. The main question it aims to answer is:

• Whether or not a 3D scan of a stoma reduces leakages and improves patient quality of life in regard to using a personalized ostomy appliance.

Participants will

* Spend 2 weeks with their standard of care ostomy appliance
* Spend 2 weeks with their personalized ostomy appliance made from a 3D scan
* Participate in daily surveys and weekly quality of life surveys conducted over the phone conditions: 3D Printing conditions: Ostomy conditions: Leakage studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 30 type: ESTIMATED name: 3D Printed Personalized Ostomy Appliance measure: Incidence of Leaks measure: Number of appliances measure: Overall patient satisfaction sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06310057 id: 4139 briefTitle: Tofacitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Dose Escalation Study overallStatus: COMPLETED date: 2022-01-01 date: 2024-03-01 date: 2024-03-01 date: 2024-03-13 date: 2024-03-13 name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh class: OTHER name: Incepta Pharmaceuticals Ltd briefSummary: The goal of this clinical trial is to assess the efficacy of tofacitinib in refractory axial spodyloarthritis (ax-SpA) with dose escalation from 10mg to 15mg. Patients will start on 10mg and then divided into 2 groups (10 and 15) at 3rd month according to major improvement criteria.

The main question\[s\] it aims to answer are:

* Efficacy and safety of tofacitinib in different doses
* If escalation of tofacitinib is justified if clinical criteria is not fulfilled at 10mg conditions: Axial Spondyloarthritis studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Dose escalation study, all the patients will recieve 10mg tofacitinib at the beginning. Then at 3rd month, one group will continue at 10mg, if they fulfill the ASDAS major improvement criteria and other group will escalate to 15mg. primaryPurpose: TREATMENT masking: NONE count: 92 type: ACTUAL name: Tofacitinib measure: To assess the ASDAS CRP major improvement criteria in refractory ax-SpA patients with dose escalation from 10mg to 15mg measure: Clinicodemographic characteristics of Ax-SpA, ASDAS CRP outcome rates, quality of life, adverse effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bangabandhu Sheikh Mujib Medical University city: Dhaka zip: 1000 country: Bangladesh lat: 23.7104 lon: 90.40744 hasResults: False

 nctId: NCT06310044 id: Commiphora Myrrh briefTitle: Effect of Commiphora Myrrh Solution as a Root Canal Irrigant on Post Operative Pain and Bacterial Load Reduction in Necrotic Tooth overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-01-01 date: 2025-01-01 date: 2024-03-13 date: 2024-03-13 name: Cairo University class: OTHER briefSummary: Clinically compare the post-operative pain , incidences post-operative swelling , post-operative number of analgesic tablets taken by patient and amount of bacterial load reduction after using 50% Commiphora Myrrh Chemomechanical preparation , versus 2.5% NaOCl,in asymptomatic necrotic mandibular premolar treated in single visit. conditions: Necrotic Pulp studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: Root canal irrigant Commiphora Myrrh 50% measure: Post-operative pain measure: incidence of Post-operative swelling measure: Amount of intracanal Bacterial CFUs/ml measure: Number of analgesic Counting Tablets taken by the patient after endodontic treatment sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06310031 id: CL-00545 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-03-13 date: 2024-03-13 name: [Redacted] hasResults: False

 nctId: NCT06310018 id: 2023A070902 briefTitle: Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE acronym: SONIC-PE overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2025-06-30 date: 2025-12-31 date: 2024-03-13 date: 2024-03-15 name: Brigham and Women's Hospital class: OTHER name: Boston Scientific Corporation briefSummary: SONIC-PE is a multicenter, prospective, single-arm study of 10 patients with bilateral PE treated with ultrasound-facilitated, catheter-directed lower-dose fibrinolysis (total dose 8 mg tPA given as 2 mg/hour/catheter over 2 hours) followed by 50 patients (total dose 6 mg tPA given as 3 mg/hour/catheter given over 1 hour) with the EKOS+™ system to determine its impact on the change in RV-to-LV diameter, refined Modified Miller Score, and distal pulmonary vascular blood volume as well as to assess International Society on Thrombosis and Haemostasis (ISTH) major bleeding. conditions: Pulmonary Embolism conditions: Right Ventricular Dysfunction conditions: Right Ventricular Failure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: multicenter, prospective, single-arm study primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Ultrasound-facilitated, catheter-directed lower-dose fibrinolysis measure: Change in RV-to-LV diameter ratio as measured by chest CT from baseline to 48 ± 6 hours measure: Frequency of ISTH major bleeding at 72 hours measure: Change in chest CT-measured blood volume in the distal pulmonary vasculature from baseline to 48 ± 6 hours measure: Change in refined Modified Miller Score as measured by chest CT from baseline to 48 ± 6 hours as measured by chest CT from baseline to 48 ± 6 hours sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06310005 id: 1466-0003 briefTitle: A Study in Healthy Japanese Men to Test How Well Different Doses of BI 3006337 Are Tolerated overallStatus: RECRUITING date: 2024-04-01 date: 2024-10-18 date: 2024-10-18 date: 2024-03-13 date: 2024-04-09 name: Boehringer Ingelheim class: INDUSTRY briefSummary: The main objectives of this trial are to investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BI 3006337 in healthy male subjects following s.c. administration of single rising doses and multiple doses over 6 weeks. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Trial consists of a single-rising dose (SRD) and multiple dose (MD) part. In SRD part, the groups will be dosed consecutively in ascending order. The decision proceeding to MD part will be based upon safety and tolerability of all the preceding dose groups in SRD part. Within each dose group, patients will be randomized to either BI 3006337 or placebo. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The trial is designed single-blind. The treatments administered (BI 3006337 or placebo) will be blinded to subjects but will be known to the investigators (outcome assessors). whoMasked: PARTICIPANT count: 36 type: ESTIMATED name: BI 3006337 name: Placebo measure: SRD + MD part: Percentage of patients with any treatment-emergent adverse event assessed as drug-related by the investigator measure: SRD part: Area under the concentration-time curve of BI 3006337 in serum over the time interval from 0 extrapolated to infinity (AUC0-inf) measure: SRD part: Maximum measured concentration of BI 3006337 in serum (Cmax) measure: MD part: Area under the concentration-time curve of BI 3006337 in serum over the dosing interval tau at steady state (AUCtau, ss) after the last dose in Week 6 measure: MD part: Maximum measured concentration of BI 3006337 in serum at steady state (Cmax, ss) after the last dose in Week 6 sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Clinical Research Hospital Tokyo status: RECRUITING city: Tokyo, Shinjuku-ku zip: 160-0004 country: Japan name: Boehringer Ingelheim role: CONTACT phone: 0120201230 email: nippon@bitrialsupport.com hasResults: False

 nctId: NCT06309992 id: 1404-0056 id: 2023-505303-23-00 type: REGISTRY domain: CTIS id: U1111-1299-9925 type: REGISTRY domain: WHO registry briefTitle: A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight overallStatus: RECRUITING date: 2024-03-13 date: 2026-02-16 date: 2026-03-09 date: 2024-03-13 date: 2024-04-16 name: Boehringer Ingelheim class: INDUSTRY briefSummary: This study is open to adults who are at least 18 years old and have

* presumed or confirmed NASH together with overweight or obesity and
* a body mass index (BMI) of 30 kg/m² or more, or
* a BMI of 27 kg/m² and at least one weight-related health problem.

People with a history of other chronic liver diseases cannot take part in this study.

The purpose of this study is to find out whether a medicine called survodutide helps people living with obesity or overweight and a confirmed or presumed liver disease called nonalcoholic steatohepatitis (NASH) to have less liver fat and to lose weight. Participants are put into 2 groups randomly, which means by chance. 1 group gets different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week for about 1 year. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.

Participants are in the study for about 1 year and 3 months. During this time, it is planned that participants visit the study site up to 13 times and receive 3 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At 3 of the visits, the participants' liver is measured using different imaging methods. The results are compared between the groups to see whether the treatment works. conditions: Obesity conditions: Non-Alcoholic SteatoHepatitis (NASH) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: Survodutide name: Placebo measure: Relative reduction in liver fat content of at least 30% from baseline to Week 48 (yes/no) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) measure: Relative change (%) in body weight from baseline to Week 48 measure: Absolute change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF measure: Relative change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF measure: Reduction from baseline to Week 48 in Iron corrected T1 (cT1) levels of ≥80 ms (yes/no) measure: Absolute change from baseline to Week 48 in alanine amino transferase (ALT) levels measure: Relative change from baseline to Week 48 in alanine amino transferase (ALT) levels measure: Absolute change from baseline to Week 48 in waist circumference [cm] measure: Relative change from baseline to Week 48 in waist circumference [cm] measure: Absolute change from baseline to Week 48 in Homeostasis Model Assessment -Insulin Resistance (HOMA-IR) (Fasting Plasma Insulin (FPI) [mlU/L] · Fasting Plasma Glucose (FPG) [mmol/L]/22.5) measure: Absolute change from baseline to Week 48 in liver stiffness assessed by magnetic resonance elastography (MRE) measure: Relative change from baseline to Week 48 in liver stiffness assessed by magnetic resonance elastography (MRE) measure: Absolute change in liver volume [mL] from baseline to Week 48 measured using MRI measure: Relative change in liver volume [mL] from baseline to Week 48 measured using MRI sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Panax Clinical Research status: RECRUITING city: Miami Lakes state: Florida zip: 33014 country: United States name: Boehringer Ingelheim role: CONTACT phone: 833-602-2368 email: unitedstates@bitrialsupport.com lat: 25.90871 lon: -80.30866 facility: Verus Clinical Research Corporation status: RECRUITING city: Miami state: Florida zip: 33135 country: United States name: Boehringer Ingelheim role: CONTACT phone: 833-602-2368 email: unitedstates@bitrialsupport.com lat: 25.77427 lon: -80.19366 facility: Louisiana Research Center, LLC status: RECRUITING city: Shreveport state: Louisiana zip: 71105 country: United States name: Boehringer Ingelheim role: CONTACT phone: 833-602-2368 email: unitedstates@bitrialsupport.com lat: 32.52515 lon: -93.75018 hasResults: False

 nctId: NCT06309979 id: 111-903 briefTitle: A Study to Assess Growth in Children With Idiopathic Short Stature overallStatus: RECRUITING date: 2024-03-25 date: 2040-12-31 date: 2040-12-31 date: 2024-03-13 date: 2024-03-13 name: BioMarin Pharmaceutical class: INDUSTRY briefSummary: Study 111-903 will generate baseline growth data in children with ISS by collecting growth measurements and other variables of interest. conditions: Idiopathic Short Stature studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 600 type: ESTIMATED measure: Change in annualized growth velocity (AGV) measure: Change in Height Z-score measure: Change in Standing Height measure: Change in BMI measure: Change in BMI Z-score measure: Frequency of event rates of medical events of interest measure: Frequency of Serious Medical Events measure: Association between specific variants and growth velocity measure: Association between other health outcomes directly related to short stature sex: ALL minimumAge: 3 Years maximumAge: 16 Years stdAges: CHILD facility: Children's National Health System status: RECRUITING city: Washington state: District of Columbia zip: 20010 country: United States lat: 38.89511 lon: -77.03637 hasResults: False

 nctId: NCT06309966 id: BHV7000-303 id: 2023-808811-21-00 type: REGISTRY domain: EU CTR briefTitle: Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy acronym: RISE 3 overallStatus: RECRUITING date: 2024-04 date: 2025-08 date: 2025-09 date: 2024-03-13 date: 2024-04-25 name: Biohaven Therapeutics Ltd. class: INDUSTRY briefSummary: The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy. conditions: Focal Epilepsy studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 390 type: ESTIMATED name: BHV-7000 name: BHV-7000 name: Placebo measure: Change from Baseline in 28-day average seizure frequency during Weeks 8 to 16 of Treatment sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dm Healthworks status: NOT_YET_RECRUITING city: Kissimmee state: Florida zip: 34741 country: United States name: Deeba Ahmad role: CONTACT phone: 407-716-1563 email: drdm22@gmail.com lat: 28.30468 lon: -81.41667 facility: Y&L Advance Health Care, Inc d/b/a Elite Clinical Research status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33144 country: United States name: Yalexis Lorenzo role: CONTACT phone: 305-262-3396 email: ylorenzo@eliteclinicalresearch.com lat: 25.77427 lon: -80.19366 facility: Research Institute of Orlando status: NOT_YET_RECRUITING city: Orlando state: Florida zip: 32806 country: United States name: Michelle Clevenger role: CONTACT phone: 407-652-6011 email: Michelle@researchinstituteoforlando.com lat: 28.53834 lon: -81.37924 facility: Comprehensive Neurology Clinic status: NOT_YET_RECRUITING city: Orlando state: Florida zip: 32825 country: United States name: Elliuz Leal role: CONTACT phone: 407-208-0708 email: elealcrc@gmail.com lat: 28.53834 lon: -81.37924 facility: Knight Neurology status: RECRUITING city: Rockledge state: Florida zip: 32955 country: United States name: Joseph Hilde role: CONTACT phone: 855-564-4484 email: jhilde01@knightneurology.com lat: 28.35084 lon: -80.72533 facility: PENS status: RECRUITING city: Tampa state: Florida zip: 33609 country: United States name: Susan Ngo role: CONTACT phone: 813-873-7367 email: sngo@pensresearch.org lat: 27.94752 lon: -82.45843 facility: University Medical Center New Orleans status: NOT_YET_RECRUITING city: New Orleans state: Louisiana zip: 70112 country: United States name: Heather Scuderi role: CONTACT phone: 504-702-4624 email: heather.scuderi@lcmchealth.org lat: 29.95465 lon: -90.07507 facility: DelRicht Research status: NOT_YET_RECRUITING city: New Orleans state: Louisiana zip: 70119 country: United States name: Reggie Mister role: CONTACT phone: 504-336-2667 email: rmister@delricht.com lat: 29.95465 lon: -90.07507 facility: UNC-Chapel Hill status: NOT_YET_RECRUITING city: Chapel Hill state: North Carolina zip: 27514 country: United States name: Monica Coudurier role: CONTACT phone: 919-966-6727 email: m_coudurier@unc.edu lat: 35.9132 lon: -79.05584 facility: Cincinatti Children's Hospital status: NOT_YET_RECRUITING city: Cincinnati state: Ohio zip: 45229 country: United States name: Nikki Kamos role: CONTACT phone: 513-803-4552 email: nichole.kamos@cchmc.org lat: 39.12713 lon: -84.51435 facility: MUSC status: NOT_YET_RECRUITING city: Charleston state: South Carolina zip: 29425 country: United States name: Robin Bulgarino role: CONTACT phone: 843-792-1115 email: bulgarino@musc.edu lat: 32.77657 lon: -79.93092 facility: WR-ClinSearch status: NOT_YET_RECRUITING city: Chattanooga state: Tennessee zip: 37421 country: United States name: Jessica Benvenuto role: CONTACT phone: 423-698-4584 email: jbenvenuto@wakeresearch.com lat: 35.04563 lon: -85.30968 facility: ANESC Research status: NOT_YET_RECRUITING city: El Paso state: Texas zip: 79912 country: United States name: Shruti Konda role: CONTACT phone: 915-974-2200 phoneExt: 3 email: shrutik@anesc.net lat: 31.75872 lon: -106.48693 facility: UTHealth Houston status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Maria Poblete role: CONTACT phone: 713-500-7201 email: Maria.Poblete@uth.tmc.edu lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06309953 id: 937 briefTitle: A Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease overallStatus: RECRUITING date: 2024-02-28 date: 2024-06-28 date: 2024-06-28 date: 2024-03-13 date: 2024-03-15 name: Bausch & Lomb Incorporated class: INDUSTRY briefSummary: An Open-Label, Multicenter, Phase 4 Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease conditions: Dry Eye studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Miebo measure: Mean change from baseline (CFB) in dry eye symptom severity at Visit 3 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Site 205 status: NOT_YET_RECRUITING city: Petaluma state: California zip: 94954 country: United States lat: 38.23242 lon: -122.63665 facility: Site 203 status: RECRUITING city: Pittsburg state: Kansas zip: 66762 country: United States lat: 37.41088 lon: -94.70496 facility: Site 204 status: NOT_YET_RECRUITING city: Stillwater state: Minnesota zip: 55082 country: United States lat: 45.05636 lon: -92.80604 facility: Site 202 status: RECRUITING city: Kansas City state: Missouri zip: 64154 country: United States lat: 39.09973 lon: -94.57857 facility: Site 201 status: NOT_YET_RECRUITING city: Brecksville state: Ohio zip: 44141 country: United States lat: 41.31978 lon: -81.62679 hasResults: False

 nctId: NCT06309940 id: Basal ganglionic haemorrhage briefTitle: Prognostic Factors for Surgical Management of Large Hypertensive Basal Ganglionic Haemorrhage overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-04 date: 2024-03-13 date: 2024-03-13 name: Assiut University class: OTHER briefSummary: The aim of this study is to present current and comprehensive recommendations for surgical treatment of this hematoma and to determine the factors that may improve the survival rate conditions: Basal Ganglionic Hemorrhage studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 25 type: ESTIMATED name: Prognostic factors of surgical evacuation of basal ganglionic haemorrhage measure: Prognostic factors of surgical evacuation of basal ganglionic haemorrhage sex: ALL minimumAge: 15 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06309927 id: 0025-24-ASF briefTitle: Operative Hysteroscopy Versus Suction Curettage for Surgical Termination of Early Pregnancy Loss (Miscarriage) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2025-12 date: 2024-03-13 date: 2024-03-13 name: Assaf-Harofeh Medical Center class: OTHER_GOV briefSummary: Non-blinded prospective randomized study. 100 women diagnosed with early pregnancy loss up to 10 gestational weeks who opted for surgical management (after being offered the options of conservative management and medical treatment) will be recruited.

Qualifying patients will sign an informed consent form and will be randomly assigned to the two arms of the study:

1. Surgical uterine evacuation by the traditional ultrasound-guided suction curettage (control group)
2. Surgical uterine evacuation by operative hysteroscopy using a tissue removal device (study group).

The surgical procedure will be determined randomly by computer generated allocation.

All surgical procedures will be performed under general anesthesia in an outpatient surgical suite. The operative time, operative blood loss and intraoperative complications will be recorded by the research team.

Following the surgical procedure, the patients will be monitored and discharged home as per our department's day-surgery protocol. Immediate post-operative complications will be recorded until discharge.

One week after the procedure, a telephone interview will be conducted to assess any procedure-related complications.

A diagnostic hysteroscopy without anesthesia will be scheduled 6 weeks postoperatively to assess for retained products of conception and for intrauterine adhesions. The diagnostic hysteroscopy will be performed by a practitioner who will be blinded to the type of surgery performed.

6 months after the procedure, a telephone questionnaire will be conducted to assess for subsequent pregnancies. conditions: Early Pregnancy Loss conditions: Intrauterine Adhesion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Operative hysteroscopy (by tissue removal device) name: Suction curettage measure: Operative complications measure: Intrauterine adhesions measure: Subsequent fertility measure: Conversion from operative hysteroscopy to suction curettage sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Shamir Medical Center city: Be'er Ya'aqov zip: 70200 country: Israel name: Noam Smorgick, MD role: CONTACT email: nsmorgik@shamir.gov.il lat: 31.93864 lon: 34.83749 hasResults: False

 nctId: NCT06309914 id: Pro00074459 briefTitle: The Effects of Mirtoselect®, Virtiva®, and Enovita® on Cognitive Performance and Mood States overallStatus: RECRUITING date: 2024-02-21 date: 2024-03-15 date: 2024-05-06 date: 2024-03-13 date: 2024-03-13 name: Applied Science & Performance Institute class: INDUSTRY briefSummary: This is a randomized, double-blind, placebo-controlled, 4-week intervention clinical study assessing the efficacy of Mirtoselect®, Virtiva® Plus, and Enovita® on cognitive performance and mood states, and the occurrence of adverse events in response to daily supplementation. The desired sample size for this study is 64 subjects. To account for potential dropouts, we aim to enroll up to 20% over the desired sample size. Therefore, this study will enroll up to 76 healthy men and women (25-55 years of age). Subjects will be randomly divided into four study groups: Placebo, Virtiva® ginkgo biloba extract, Mirtoselect® bilberry extract, or Enovita® grape seed extract. Blocked randomization will be deployed in which subjects are divided into blocks of 4 subjects and each subject within a block is randomly assigned to one of the four study groups. conditions: Mental Processes conditions: Cognitive Change conditions: Mood Change studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: Placebo name: Enovita Grape Seed Extract name: Mirtoselect Bilberry Extract name: Virtiva Plus Ginko Biloba Extract measure: Change in Visual Memory measure: Change in Verbal Memory measure: Change in Finger Tapping Test (FTT) Results measure: Change in Symbol Digit Coding (SDC) Test Results measure: Change in Stroop Test Results measure: Change in Shifting Attention Test Results measure: Change in Continuous Performance Test Results measure: Change in Abbreviated Profile of Mood States (POMS) Score sex: ALL minimumAge: 25 Years maximumAge: 55 Years stdAges: ADULT facility: Applied Science and Performance Institute status: RECRUITING city: Tampa state: Florida zip: 33607 country: United States name: Jacob Wilson, PhD role: CONTACT phone: 813-673-8888 email: jwilson@theaspi.com name: Justine Davis, MS role: CONTACT phone: 813-673-8888 email: jdavis@theaspi.com lat: 27.94752 lon: -82.45843 hasResults: False

 nctId: NCT06309901 id: ankaraYBU2019-199 briefTitle: Facial Distortion Model and Instrument Assisted Soft Tissue Mobilization Techniques overallStatus: COMPLETED date: 2019-06-30 date: 2021-12-01 date: 2022-05-31 date: 2024-03-13 date: 2024-03-13 name: Ankara Yildirim Beyazıt University class: OTHER briefSummary: To compare the effects of facial distortion model and equipment assisted soft tissue mobilization techniques on the treatment process, which are among the applications in the rehabilitation process after meniscus repair. conditions: Meniscus Injury studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 33 type: ACTUAL name: Exercise name: Fascial Distortion Model name: Instrument Assisted Soft Tissue Mobilisation measure: Visual Analog Scale measure: environmental measurement measure: Power Track Manuel Muscle Tester measure: sit and reach test measure: Goniometric measurement measure: The Western Ontario Meniscal Evaluation Tool (WOMET ) measure: Lysholm Knee Score sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Yıldırım Beyazıt University Yenimahalle Training and Research Hospital city: Ankara zip: 06010 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06309888 id: 2023-18 briefTitle: Magnetic Resonance Imaging of Cognitive Deficits in the Brain of Individuals With Spinal Cord Injury acronym: SCI_Cog overallStatus: RECRUITING date: 2024-02-01 date: 2026-12 date: 2026-12 date: 2024-03-13 date: 2024-03-13 name: Swiss Paraplegic Research, Nottwil class: NETWORK briefSummary: In the case of spinal cord injury, rehabilitation is particularly focused on motor skills. Non-motor impairments such as thinking difficulties did not receive a lot of attention to date.

In this research project, the investigators want to find out how thinking difficulties become noticeable in the brain with spinal cord injury.

Participation procedure: Participants who take part will be asked to come to an examination once. The duration of the examination is between 2 and 2.5 hours (including around 55 minutes in the magnetic resonance imaging scanner, including preparation and follow-up). conditions: Spinal Cord Injury studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: Brain activity measure: Behavioral performance measure: Behavioral performance measure: Behavioral performance measure: Behavioral performance measure: Behavioral performance measure: Brain morphometry measure: Level of life satisfaction measure: Level of anxiety measure: Level of pain measure: Quality of sleep measure: Level of attention and awareness measure: Motor symptom severity measure: Demographics sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Swiss Paraplegic Research status: RECRUITING city: Nottwil state: Lucerne zip: 6207 country: Switzerland name: Jothini Sritharan, MSc role: CONTACT phone: +41419396557 email: jothini.sritharan@paraplegie.ch name: Jothini Sritharan, MSc role: SUB_INVESTIGATOR lat: 47.13472 lon: 8.13772 hasResults: False

 nctId: NCT06309875 id: ENF- 25-2018 briefTitle: Effect of the PLAN CUIDARTE on the Caregiving Competence of People With Heart Failure acronym: PLANCUIDARTE overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-06-25 date: 2024-11-12 date: 2024-03-13 date: 2024-03-13 name: Universidad de la Sabana class: OTHER name: Universidad de Caldas briefSummary: According to the World Health Organization (WHO), by 2021 cardiovascular diseases (CVD) will be a public health problem, among them heart failure (HF), since this is a chronic disease, patients should be competent in their care. Despite the above, according to research conducted in Colombia, 59.7% of people with chronic noncommunicable diseases (NCDs) have a level of care competence considered not optimal; patients report not having sufficient knowledge of the disease or experience feelings of lack of tools for the management of symptoms and the challenges of post-hospitalization.

The objective of the research is to determine the effect of the PLAN CUIDARTE on the caregiving competence of people with HF

Methodology: Pre-posttest randomized clinical trial, with blinding of the participants, where the intervention "PLAN CUIDARTE" is applied and the initial and subsequent caregiving competence is evaluated in the comparison group and in the intervention group for pretest - posttest and between-group comparisons. conditions: Heart Failure conditions: Caregiver Burden conditions: Discharge Plan conditions: Care Transitions conditions: Nursing studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A pre-post test Randomized Clinical Trial (RCT) is proposed with a comparison group, with blinding of the participants with blinding of the participants, with application of a pilot test beforehand. pilot test.

The intervention group is established as the group that receives the PLAN CUIDARTE (intervention described later) and as a comparison group the one receiving the conventional discharge plan (described later) primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 84 type: ESTIMATED name: PLAN CUIDARTE name: Conventional care measure: Care Competence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universidad de Caldas city: Manizales state: Caldas zip: 170004. country: Colombia name: Claudia Marcela Vallejo, Mag role: CONTACT phone: +573163614224 email: marcela.vallejo@ucaldas.edu.co lat: 5.06889 lon: -75.51738 hasResults: False

 nctId: NCT06309862 id: 5993 briefTitle: Immune Checkpoint Inhibitor Therapy for Cancer and Risk of Myocarditis or Cardiomyopathy overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2025-09-30 date: 2025-12-31 date: 2024-03-13 date: 2024-03-13 name: Sunnybrook Health Sciences Centre class: OTHER briefSummary: Patients undergoing dual treatment with Immune checkpoint inhibitors (ICI) for various cancers, e.g. melanoma, are at increased risk of developing myocarditis and cardiomyopathy. Currently, only limited data on serial myocardial tissue changes during treatment and whether they predict outcomes are available. Cardiac MRI (CMR) is the reference standard for non-invasive myocardial volumes/function analysis and uniquely characterizes myocardial tissue. Therefore, it may help detect myocardial tissue changes during treatment and help early treatment and prevent adverse cardiac outcomes. conditions: Cardio-Oncology conditions: Cardiomyopathy Due to Drug studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 15 type: ESTIMATED measure: Define changes in CMR tissue and blood biomarkers during ICI treatment. measure: Investigate associations between CMR imaging biomarkers and CMR-defined left ventricular ejection fraction. measure: Investigate associations between serum biomarkers and CMR-defined left ventricular ejection fraction. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06309849 id: Jerash University briefTitle: Efficacy of Physical Therapy Intervention in Cervical Angina Patients at Jerash University Office Employees, "Randomized Clinical Trail". overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-05-20 date: 2024-06-01 date: 2024-03-13 date: 2024-04-08 name: South Valley University class: OTHER briefSummary: Cervicogenic angina (CA) is defined as paroxysmal angina- like pain that originates from the disorders of the cervical spine or other neck structures. Because CA mimics typical cardiac angina, symptoms in the elderly with cervical spondylosis are more frequently misdiagnosed Nakajima H, 2006. Patients with CA may have suffered symptoms for longer periods of time and seen several clinicians due to conflicting cardiac exams. Clinicians and patients are unaware that CA symptoms are stemming from cervical spine disorders. However, the mechanism of pain occurrence in patients with CA remains unclear. conditions: Cervical Radiculopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Control Trail (RCT) will be used in the study. Participants will be dived into experimental group and control group. Each group will includes 30 participants. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: includes 30 participants. whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Manual physiotherapy intervention( cervical traction, suboccipital release, muscle energy technique) measure: 1-Hart Rate (HR) (bpm) using Electro Cardiac Graphic (ECG). 2- Blood pressure (mm Hg) using Sphygmomanometer. measure: 3- Range of Motion (ROM) (in degrees) of the cervical spine using Electro-Goniometer. 4- the pain using Visual Analogue Scale (VAS) from (0-10) sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06309836 id: SID03 briefTitle: Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma acronym: REGISTRO-BCC overallStatus: RECRUITING date: 2021-06-23 date: 2024-06-23 date: 2024-06-23 date: 2024-03-13 date: 2024-03-13 name: Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse class: OTHER briefSummary: Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma. conditions: Basal Cell Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 250 type: ESTIMATED measure: clinical evolution, treatment and prognosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Irccs Fondazione Policlinico Gemelli status: RECRUITING city: Roma state: ITA zip: 00168 country: Italy name: peris MD Peris role: CONTACT phone: 0630154211 email: ketty.peris@unicatt.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06309823 id: 1000080330 briefTitle: A Single-patient Clinical Trial of MAS825 in a Patient With XIAP Deficiency overallStatus: COMPLETED date: 2023-02-08 date: 2024-01-17 date: 2024-01-17 date: 2024-03-13 date: 2024-03-13 name: The Hospital for Sick Children class: OTHER briefSummary: MAS825 is a bi-specific IgG1 monoclonal antibody that simultaneously targets IL-1 beta and IL-18, thereby neutralizing both cytokines that are thought to be integral to the pathogenesis of XLP-2. Clinical trials are currently examining its efficacy in other diseases associated with elevations of these cytokines, including NLRC4-associated disease and hidradenitis suppurativa. This study proposes to assess the effectiveness of MAS825 in a single patient with XLP-2, who has previously demonstrated response to blockade of IL-1 beta and IL-18. Given the lack of alternative pharmaceutical options for XLP-2, this represents the only known medication option that avoids the toxicity associated with high-dose corticosteroids and the morbidity associated with hematopoietic stem cell transplantation. conditions: X-linked Lymphoproliferative Syndrome Type 2 (XLP-2) studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1 type: ACTUAL name: MAS825 measure: Impact of MAS825 on Physician Global Assessment Score measure: Impact of MAS825 on Physician Severity Assessment of Disease Signs and Symptoms measure: Patient/Parent Global Assessment of Disease Activity sex: MALE minimumAge: 13 Years maximumAge: 14 Years stdAges: CHILD facility: The Hospital for Sick Children city: Toronto state: Ontario zip: M5G1X8 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06309810 id: 2022-35 briefTitle: Stereotactic Radiosurgery (SRS) in Malignant Spasticity and Hypertonia overallStatus: RECRUITING date: 2023-03-06 date: 2025-08 date: 2025-08 date: 2024-03-13 date: 2024-03-13 name: IRCCS Sacro Cuore Don Calabria di Negrar class: OTHER briefSummary: This is a pilot, experimental, monocentric study. The main objective of the study is to evaluate whether stereotactic radiotherapy is able to reduce symptomatic spasticity from a clinical point of view, and therefore induce an improvement in posture and quality of life in patients with malignant spasticity.

The study foresees the enrollment of about 10 patients, in a period of 24 months. The radiotherapy treatment will be delivered in a single session with an image-guided stereotaxic technique, and a prescription dose between 45 and 60 Gy; subsequently the patients will be followed up for one year. conditions: Spasticity/Paresis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Radiotherapy measure: MAS measure: Acute and late toxicity (CTCAE) measure: Quality of life (SF-12) measure: Quality of nursing (VAS) measure: Radiological characteristics and treatment-related changes of the spinal roots sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Sacro Cuore Don Calabria di Negrar status: RECRUITING city: Negrar state: Verona zip: 37024 country: Italy name: Luca Nicosia, Doctor role: CONTACT phone: +39(0)456014800 email: luca.nicosia@sacrocuore.it lat: 45.52918 lon: 10.93899 hasResults: False

 nctId: NCT06309797 id: OSATAGUN2 briefTitle: Effects of Interdental Brush Dipped in 0.2% Hyaluronic Acid Gel on Periodontitis overallStatus: COMPLETED date: 2023-05-02 date: 2024-01-26 date: 2024-02-05 date: 2024-03-13 date: 2024-03-13 name: Özlem SARAÇ ATAGÜN class: OTHER briefSummary: This study aimed to compare the effects of using an interdental brush dipped in 0.2% HA gel with those of using a regular interdental brush on clinical periodontal parameters following SRP among patients with periodontitis. conditions: Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: single-center, single-blinded, randomized controlled trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The investigator carrying out the measurements was not aware of which patients were assigned to the test group. whoMasked: INVESTIGATOR count: 60 type: ACTUAL name: Interdental brush+HA name: Interdental brush measure: Gingival index (GI) measure: Plaque index (PI) measure: Papillary bleeding index (PBI) measure: Pocket depth (PD) measure: Clinical attachment loss (CAL) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi city: Ankara zip: 06010 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06309784 id: RD 2595 id: NIHR II-LA-1116-20004 type: OTHER_GRANT domain: NIHR briefTitle: Development of a Drill Guidance System to Aid Intra-operative Surgical Drilling overallStatus: RECRUITING date: 2024-03-19 date: 2024-07-31 date: 2024-10-31 date: 2024-03-13 date: 2024-04-10 name: Royal United Hospitals Bath NHS Foundation Trust class: OTHER name: University of Bath name: Great Western Hospitals NHS Foundation Trust briefSummary: The Investigators have developed a camera based drill guidance system to improve the accuracy of surgical drilling. The aim of the study is to assess:

Accuracy in vivo Safety Acceptability of use amongst surgeons and theatre staff conditions: Orthopaedic Surgery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Participants undergoing orthopaedic Surgery primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Drill Guidance System (DGS) measure: Accuracy of placement of a screw or K wire in scaphoid bones measure: Accuracy of placement of a screw or K wire in other bones measure: Length of material part of the procedure measure: Number of fluoroscopy (perioperative X-ray) images performed measure: Number of patients with treatment related adverse events as assessed by CTCAE v4.0 measure: Immediate acceptability to surgeons and theatre staff measure: Initial acceptability to surgeons and theatre staff measure: Overall acceptability to surgeons and theatre staff sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal United hospitals NHS Foundation Trust status: RECRUITING city: Bath country: United Kingdom name: Jane Carter, BSc role: CONTACT phone: 01225821095 email: jane.carter14@nhs.net lat: 51.3751 lon: -2.36172 facility: Great Western Hospital MHS foundation Trust status: RECRUITING city: Swindon country: United Kingdom name: Adam Smith, FRCS role: CONTACT phone: 07533793889 email: adam.smith@doctors.org.uk lat: 51.55797 lon: -1.78116 hasResults: False

 nctId: NCT06309771 id: PROMESS - QOL briefTitle: Preventive Remediation for Optimal MEdical StudentS (PROMESS) acronym: PROMESS overallStatus: ENROLLING_BY_INVITATION date: 2023-11-11 date: 2024-09-30 date: 2024-09-30 date: 2024-03-13 date: 2024-03-13 name: Research on Healthcare Performance Lab U1290 class: OTHER briefSummary: Medical students are under a great deal of competitive pressure throughout their training. During their studies, medical students experience high levels of stress, sleep disorders and excessive physical inactivity. These feelings and behaviours are expected to significantly degrade their quality of life, health and performance.

The PROMESS project aims to increase students' quality of life and ultimately improve their medical performance. The project aims to improve students' ability to take care of themselves from a short and long term perspective.

Encouraging physical activity, reducing sedentary behaviors, reducing stress, fatigue and sleep troubles during their curriculum can promote a healthier lifestyle and reduce the risk of chronic health conditions in the future.

The study seeks to quantify the impact of a complex intervention based on 3 modules (stress, sleep, physical activity) on the quality of life and academic performance of 2nd cycle medical students. This study will also have a clear insight on the influence of the complex intervention on changes in stress, sleep, physical activity and sedentary behavior markers. conditions: Health Behavior conditions: Health-Related Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled clinical trial. Randomization into two groups: INTERVENTION group and CONTROL group. The INTERVENTION group will have the opportunity to follow a preventive remediation program based on 3 modules: stress management, sleep improvement and fatigue reduction, and sedentary behaviors reduction and physical activity promotion. The order of following the 3 modules will be randomized. The CONTROL group will not receive any intervention. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Assessors of pre and posttest measures will be blinded to the group allocation. whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Stress management, sleep improvement and fatigue reduction, sedentary behaviors reduction and physical activity promotion. measure: Quality of life. Change from pre-intervention in a composite score obtained at the Brief Quality Of Life questionnaire at the post-interventional measure at Week 27. measure: Academic self-efficacy. Change from the pre-intervention in score obtained at the Academic self-efficacy questionnaire at the post-interventional measure at Week 27. measure: Wu self efficacy questionnaire. Change from pre-intervention in score obtained at the adapted Wu self efficacy questionnaire at the post-interventional measure at Week 27. measure: Academic performances. Scores and ranks obtained at all the official exams during the 2023-2024 academic year. measure: VAS - quality of life. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of Quality Of Life measure: VAS - self-confidence. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of self-confidence. measure: VAS - self-efficacy. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of self-efficacy. measure: VAS - resources. Evolution of the score obtained at the 100-mm Visual Analogue Scale assessing the perceived level of resources. measure: VAS - work-life balances. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the work-life balances. measure: VAS - stressors quantity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived quantity of stressors. measure: VAS - stress quality: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the emotional valence associated with the stress level. measure: VAS - stress coping. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the management of stressful situations. measure: VAS - stress quantity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of stress. measure: VAS - sleep quality. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) characterizing the sleep quality. measure: VAS - sleep quantity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the quantity of sleep. measure: VAS - sleep fatigue. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of fatigue. measure: VAS - physical fitness. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of physical fitness. measure: VAS - physical activity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the level of physical activity. measure: VAS - sedentary behaviors. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of sedentary behaviors. measure: Perceived level of stress. Change from pre-intervention in score obtained at the Perceived Stress Scale (PSS) at the post-interventional measure at Week 27. measure: Coping strategies.Change from pre-intervention in scores obtained at the Brief Cope Inventory (BCI) at the post-interventional measure at Week 27. measure: Quantity of stressors. Score obtained at the Holmes and Rahe Questionnaire Inventory during the pre-intervention. measure: Big-5. Scores obtained at the Big-5 questionnaire. measure: Perceived level of sleep troubles. Change from pre-intervention in score obtained at the Pittsburgh Sleep Questionnaire Inventory (PSQI) at the post-interventional measure at Week 27. measure: Epworth Sleepiness scale. Change from the pre-intervention in score obtained at the Epworth Sleepiness scale at the post-interventional measure at Week 27. measure: Multidimensional Fatigue. Change from the pre-intervention in score obtained at the Multidimensional Fatigue Inventory (MFI) at the post-interventional measure at Week 27. measure: Reduced composite scale of morningness. Score obtained at the reduced composite scale of morningness (RCSMS). measure: Perceived level of physical activity. Change from the pre-intervention in score obtained at the Global Physical Activity Questionnaire (GPAQ) at the post-interventional measure at Week 27. measure: Perceived level of sedentary. Change from the pre-intervention in score obtained at the Rapid Physical Activity Questionnaire (RPAQ) at the post-interventional measure at Week 27. measure: Heart rate variability (HRV) marker. Change from pre-intervention in cardiac coherence at the post-interventional measure at Week 27. measure: Heart rate variability (HRV) marker. Change from pre-intervention in the SDNN score in at the post-interventional measure at Week 27. measure: Heart rate variability (HRV) marker. Change from pre-intervention in the RMSSD score in at the post-interventional measure at Week 27. measure: Heart rate variability (HRV) marker. Change from pre-intervention in the pnn50% score in at the post-interventional measure at Week 27. measure: Heart rate variability (HRV) markers.Change from pre-intervention in the Low frequency / High frequency ratio (LF/HF) ratio in at the post-interventional measure at Week 27. measure: Actimetry records. Change from pre-intervention in Time in Bed at the post-interventional measure at Week 27. measure: Actimetry records. Change from pre-intervention in Total Sleep duration at the post-interventional measure at Week 27. measure: Actimetry records. Change from pre-intervention in Sleep efficiency at the post-interventional measure at Week 27. measure: Actimetry records. Change from pre-intervention in Sleep Onset Latency at the post-interventional measure at Week 27. measure: Actimetry records. Change from pre-intervention in Wake after Sleep Onset at the post-interventional measure at Week 27. measure: Actimetry records. Change from pre-intervention in Number of Awakenings at the post-interventional measure at Week 27. measure: Actimetry records. Change from pre-intervention in Mid-sleep point at the post-interventional measure at Week 27. measure: Actimetry records. Change from pre-intervention in Bedtime at the post-interventional measure at Week 27. measure: Actimetry records. Change from pre-intervention in Sleep Onset time at the post-interventional measure at Week 27. measure: Actimetry records. Change from pre-intervention in Sleep Inertia at the post-interventional measure at Week 27. measure: Actimetry records. Change from pre-intervention in Wake-up time at the post-interventional measure at Week 27. measure: Actimetry records. Change from pre-intervention in Sleep regularity index at the post-interventional measure at Week 27. measure: Actimetry records. Change from pre-intervention in Total activity at the post-interventional measure at Week 27. measure: Actimetry records. Change from pre-intervention in Moderate-to-vigorous Physical Activity (MVPA) at the post-interventional measure at Week 27. measure: Actimetry records. Change from pre-intervention in light physical activity at the post-interventional measure at Week 27. measure: Actimetry records. Change from pre-intervention in Steps count at the post-interventional measure at Week 27. measure: Actimetry records. Change from pre-intervention in energy expenditure at the post-interventional measure at Week 27. measure: Actimetry records. Change from pre-intervention in sedentary breaks at the post-interventional measure at Week 27. measure: Actimetry records. Change from pre-intervention in Sedentary time at the post-interventional measure at Week 27. measure: Actimetry records. Change from pre-intervention in prolonged sedentary bouts at the post-interventional measure at Week 27. measure: Actimetry records. Change from pre-intervention in vector of the dynamic body acceleration (VeDBA) at the post-interventional measure at Week 27. measure: Physical fitness markers - Strength. Change from pre-intervention in the force developed during a maximal isometric contraction of the quadriceps at the post-interventional measure at Week 27. measure: Physical fitness markers - Power. Change from pre-intervention in height of jump at the post-interventional measure at Week 27. measure: Physical fitness markers - Power. Change from pre-intervention in time of flight at the post-interventional measure at Week 27. measure: Physical fitness markers - Power. Change from pre-intervention in relative power at the post-interventional measure at Week 27. measure: Physical fitness markers - Endurance. Change from pre-intervention in speed through the endurance test at the post-interventional measure at Week 27. measure: Physical fitness markers - Endurance. Change from pre-intervention in VO2max through the endurance test at the post-interventional measure at Week 27. measure: Physical fitness markers - Endurance. Change from pre-intervention in heart rate during the endurance test at the post-interventional measure at Week 27. measure: Body composition markers. Change from the pre-intervention in Body Mass Index (BMI) at the post-interventional measure at Week 27. measure: Body composition markers. Change from the pre-intervention in fat mass at the post-interventional measure at Week 27. measure: Body composition markers. Change from the pre-intervention in Skeletal muscle mass at the post-interventional measure at Week 27. measure: Body composition markers.Change from the pre-intervention in total body hydration at the post-interventional measure at Week 27. measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the stress module. measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the sedentary behaviors and physical activity module. measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the sleep module. measure: Question recommendation. Answer to the question "Would you recommend a friend to participate at the PROMESS project?" asked during the post-intervention. measure: Question Habits change. Answer to the question "Do you think that your participation at the PROMESS project has modified your health behaviors/actions?" asked during the post-intervention. measure: Question Habits change. Answer to the question ""For which behaviors do you think you have modified your habits/actions?" asked during the post-intervention. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RESHAPE city: Lyon zip: 69008 country: France lat: 45.74848 lon: 4.84669 hasResults: False

 nctId: NCT06309758 id: 115022 briefTitle: BreinZorg: Feasibility Study Into an Online Lifestyle Platform for MCI and SCD overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-15 date: 2025-04-15 date: 2024-03-13 date: 2024-04-10 name: Radboud University Medical Center class: OTHER briefSummary: Dementia is the most common disease in older individuals and this century's biggest healthcare challenge. Many patients who visit the memory clinic with memory complaints do not have dementia but instead are diagnosed with mild cognitive impairment (MCI) or subjective cognitive decline (SCD). MCI or SCD may be a pre-dementia stage. Many patients with MCI or SCD often leave their consultation with unanswered questions, and unsure what they, themselves can do to reduce dementia risk. Patients with MCI and SCD have a heightened risk of developing dementia. Therefore, this group would possibly benefit most from preventive strategies. Around 40% of dementia cases is attributable to modifiable factors. Thus, managing a healthy lifestyle may reduce dementia risk.

To answer the information request many patients have when leaving the memory clinic and to fill the knowledge gap an online tool has been developed.

The goal of this mixed-method feasibility study is to investigate the usability, feasibility, patient experience, and effectiveness of the personalized, multi-domain online website in older adults with MCI or SCD.

The main questions it aims to answer are:

* Is the new website being used by the target population?
* How does the target population experience the use of the website?
* What is the effect of using the website?

Participants will have access to the website and are free to use the website in any way they want. conditions: Mild Cognitive Impairment conditions: Cognitive Decline studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: mixed-method study with a single-arm pre-post design with a duration of 3 months and extended follow-up after 6 months. primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: Breinzorg measure: Acceptability of the new online website following the theoretical framework of acceptability measure: Adoption / Uptake of the new online website. Website usage data. measure: Demand of the new online website. Website usage data. measure: Practicality of the new online website. measure: Feeling of trust in yourself and your own abilities. measure: Feeling of control about own life and future. measure: Motivation to change lifestyle for reduction of dementia risk. measure: Awareness about dementia risk reduction measure: Change in alcohol consumption measure: Change in smoking behaviour measure: Change in physical exercise. measure: Change in Diet. measure: Change in Sleep behaviour measure: Change in cognitive activities. measure: Change in Stress levels measure: Change in Mental health Quality of Life sex: ALL minimumAge: 61 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06309745 id: THERATEST briefTitle: THERApy De-escalation for TESTicular Cancer acronym: THERATEST overallStatus: RECRUITING date: 2024-01-25 date: 2027-05 date: 2027-12 date: 2024-03-13 date: 2024-03-13 name: Queen Mary University of London class: OTHER briefSummary: THERATEST is looking to collect data from 30 patients actively receiving de-escalation treatments or other standard of care treatments in two UK hospitals. THERATEST is a feasibility study to determine whether patients are willing to be recruited, the impact of de-escalation treatments on patients' cancers and quality of life, whether we should proceed with these treatments in a larger study, and if so how the study should be conducted. A feasibility study prepares the ground for a larger study and improves the chances of the subsequent study producing valuable evidence, and helps to avoid wasting precious resources on larger trials that are unlikely to be informative. We hope that information from THERATEST will bridge the current knowledge gap and allow clinicians to design bigger trials to actively compare the different treatment strategies. conditions: Seminoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: retroperitoneal lymph node dissection name: Carboplatin AUC10 measure: FEASIBILITY of recruitment and retention measure: QUALITY OF LIFE assessed by difference in HRQOL scores measure: QUALITY OF LIFE assessed by difference in differences in sexual drive, function, and overall satisfaction measure: Progression free SURVIVAL measure: OVERALL SURVIVAL measure: SAFETY and complication of all treatments sex: MALE minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Barts and London Hospital NHS Trust status: RECRUITING city: London country: United Kingdom name: THERATEST Study coordinator role: CONTACT lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06309732 id: 4491 id: 2006-001963-52 type: EUDRACT_NUMBER id: TE 2006-09 type: OTHER domain: Barts and the London NHS Trust briefTitle: GAMEC-II, Risk-adapted Protocol for Relapsed Germ Cell Tumours (GCT) acronym: GAMEC-II overallStatus: COMPLETED date: 2006-07 date: 2013-06 date: 2014-01 date: 2024-03-13 date: 2024-03-13 name: Queen Mary University of London class: OTHER briefSummary: St Bartholomew's hospital completed a study using the regimen GAMEC (PEG-filgrastim, actinomycin-D, methotrexate, etoposide, cisplatin). The results of this study showed that 50% of patients with relapsed testicular cancer could be cured using this treatment. These results are very encouraging and compare very favourably to other treatment protocols. In reviewing this study, it became clear that of the 5 cycles of treatment which were proposed, the first 3 seemed to matter and the last 2 did not appear important. In addition there was a group of patients who appeared to do particularly well namely patients under the age of 35 and those who had a normal LDH (lactate dehydrogenase). LDH is a blood test which monitors cancer activity. Selecting patients which fill both these criteria, this trial aims to see whether the investigators can maintain the good results the investigators have seen but using only 3 cycles of treatment. This will therefore shorten the treatment from 10 weeks to 6 weeks, thus reducing the side effects. conditions: Testicular Neoplasms studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 36 type: ACTUAL name: Pegfilgrastim name: Dactinomycin name: Methotrexate name: Etoposide name: Cisplatin name: Epirubicin measure: Response rate to GAMEC-S or GAMEC-A measure: Relapse-free survival measure: Overall survival sex: MALE minimumAge: 16 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Barts and the London NHS Trust city: London zip: EC1A 7BE country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06309719 id: 339479 briefTitle: Hyaluronic Acid and Polynucleotides for Supra-bony Defects overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-09 date: 2025-11 date: 2024-03-13 date: 2024-03-13 name: Queen Mary University of London class: OTHER name: Geistlich Pharma AG briefSummary: The goal of this pilot study is to describe the early wound healing molecular events and the vascularization pattern associated with the treatment of supra-bony defects with access flap alone or in association with a combined formulation of hyaluronic acid and polydeoxyribonucleotides gel. conditions: Periodontal Diseases conditions: Wound Heal conditions: Periodontal Inflammation conditions: Periodontal Pocket conditions: Periodontal Attachment Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Periodontal Access Flap (AF) + Combined Formulation of Hyaluronic acid and Polydeoxyribonucleotides (PNHA) name: Periodontal Access Flap (AF) measure: Early wound healing molecular events through GCF measure: Early gingival tissue vascularization pattern when supra-bony defects are treated with AF, in association or not with PNHA measure: Periodontal parameters and periodontal inflamed surface area (PISA) on the teeth involved in the surgery measure: Probing pocket depth (PPD) measure: Gingival recession (REC) measure: Clinical attachment level (CAL) measure: Suppuration measure: Gingival phenotype measure: Keratinized tissue (KT) measure: Full mouth plaque score (FMPS) measure: Full mouth bleeding score (FMBS) measure: Early Healing Index (EHI) measure: Gingival morphometric changes measure: Oral impact on daily performance (OIDP) measure: Dentine/root sensitivity measure: Food impaction measure: Patient perception about therapy measure: Global ratings of Periodontal Health and Quality of Life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Barts Health NHS Trust Dental Hospital city: London zip: E1 1BB country: United Kingdom name: Vandana Luthra role: CONTACT phone: +44(0)207 882 6348 email: BHNT.Clinicaloralresearchcentre@nhs.net name: Elena Calciolari, DDS, MS, PhD role: CONTACT email: e.calciolari@qmul.ac.uk lat: 51.50853 lon: -0.12574 facility: Centre for Oral Clinical Research (COCR) city: London zip: E1 2AD country: United Kingdom name: Vandana Luthra role: CONTACT phone: +44(0)207 882 6348 email: BHNT.Clinicaloralresearchcentre@nhs.net name: Elena Calciolari, DDS, MS, PhD role: CONTACT email: e.calciolari@qmul.ac.uk lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06309706 id: JXHU briefTitle: A Retrospective Cone Beam Computed Tomography Study of The Lateral Wall Bony Window overallStatus: COMPLETED date: 2019-09-01 date: 2020-01-01 date: 2020-12-31 date: 2024-03-13 date: 2024-03-13 name: The Dental Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: Three experienced observers were asked to screen all the CBCT images from the Stomatology Hospital,Zhejiang University School of Medicine, between September 1, 2019 and December 31, 2019, and counted 1000 maxillary sinus CBCT images that met the criteria. Later, 1000 CBCT images were further measured and analyzed, and indicators such as maxillary sinus buccal wall thickness, morphology, whether there is blood vessel or not, whether there is bone septa or not were counted. The variation rules and related factors were summarized by SPSS analysis. conditions: Lateral Wall Thickness studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 1000 type: ACTUAL name: No intervention measure: Lateral wall thickness sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06309693 id: IRB-300011310 briefTitle: Postoperative Pain Management Following Robotic Assisted Sacrocolpopexy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-10 date: 2025-10 date: 2024-03-13 date: 2024-04-05 name: University of Alabama at Birmingham class: OTHER briefSummary: In the effort to reduce postoperative opioid use, there has been increasing interest in developing multimodal pain regimens to better manage postoperative pain while minimizing opioid use and their subsequent side effects that can be detrimental to the healing process. Standard of care approaches to better manage postoperative pain include the Enhanced Recovery After Surgery (ERAS) protocol and the use of peripheral and truncal nerve blocks. Truncal nerve blocks are widely used as an additional modality to provide longer lasting postoperative analgesia and have been adopted as part of the standard of care. The goal of this clinical trial is to compare the effects of ERAS alone versus the quadratus lumborum (QL) nerve block on the postoperative pain experience for women with pelvic organ prolapse undergoing robotic assisted sacrocolpopexy. Subjects will be randomized to the ERAS protocol or the QL block. The main questions the study aims to answer are: 1) does the QL block decrease patient reported pain scores postoperatively; and 2) does the QL block decrease the amount of opioid pain medications in the immediate postoperative period? The primary outcome measure will be median patient reported pain score in the post-anesthesia care unit (PACU) following surgery. conditions: Pelvic Organ Prolapse conditions: Post Operative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will be a randomized control trial in which patients undergoing robotic-assisted sacrocolpopexy with concurrent robotic assisted hysterectomy or robotic assisted sacrocolpopexy after previous hysterectomy will be randomized to one of two standard of care approaches for postoperative pain management: the enhanced recovery after surgery (ERAS) protocol and the quadratus lumborum truncal nerve block. Subjects will undergo one of two standard of care approaches to postoperative pain management and be asked about their pain postoperatively. primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: Quadratus Lumborum (QL) Block name: Enhanced Recovery After Surgical (ERAS) Protocol measure: Median postoperative patient reported pain score in post-anesthesia recovery unit (PACU) measure: Maximum postoperative patient reported pain score in PACU measure: Total oral morphine equivalents (OME) required in PACU Total oral morphine equivalents (OME) required in post-anesthesia recovery unit measure: Rates of postoperative nausea and vomiting (PONV) in PACU measure: Rates of overnight admission measure: Total time spent in PACU measure: Rates of initial active voiding trial failures sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06309680 id: 280992 briefTitle: Accuracy of Metagenomic Blood Sampling to Identify Pathogen in Infective Endocarditis Patients acronym: AMetIP overallStatus: RECRUITING date: 2023-04-24 date: 2025-07-31 date: 2025-07-31 date: 2024-03-13 date: 2024-03-13 name: Queen Mary University of London class: OTHER name: Barts & The London NHS Trust name: Quadram Institute Bioscience briefSummary: Infective Endocarditis is an infection, usually a bacterium, which attacks the heart and can cause valves to leak and produces a bacterial mass which can break off from the valves and block the blood supply to important organs.

We are very keen to improve the treatment of this disease and we are measuring the impact of the treatments that we give to patients so that we have a very clear idea of which treatments work best and also which treatments are less successful.

A key part of the treatment is the accurate determination of the causative organism which allows appropriate targeted antibiotic and antifungal medication to be administered.

Accurate antibiotic regimes require detection of the causative organism and its sensitivities to each antibiotic. Antibiotic choice is then based on effectiveness, toxicity, ease of use and national guidelines. The current best technique for identifying bacteria is blood culture where organisms are identified by growing them from blood samples. However, this takes up to 5 days from sampling, resulting in delays to the correct diagnosis. Until this time, treatment requires the use of generic, more toxic antibiotic regimes.

New techniques are emerging to identify causative organisms from blood. Metagenomics allows the sequencing of bacterial DNA allowing precise identification of the infecting organism. conditions: Infective Endocarditis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: diagnostic accuracy of CMg in blood measure: to evaluate the results of Nanopore CMg in identifying the causative organism in patients with BCNIE measure: 1. Optimal timing of blood sampling measure: 3. Metagenomic Techniques sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St Bartholomew's Hospital. West Smithfield status: RECRUITING city: London zip: EC1A 7BE country: United Kingdom name: Innocent M Bvekerwa role: CONTACT phone: 07852209005 email: i.bvekerwa@nhs.net name: Simon Woldman role: CONTACT email: simon.woldman@nhs.net lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06309667 id: SL-MG12-P1 briefTitle: A Study to Assess Safety, Pharmacokinetics and Pharmacodynamics of PG-102(MG12) in Healthy Volunteers overallStatus: RECRUITING date: 2023-10-17 date: 2024-06-26 date: 2024-06-26 date: 2024-03-13 date: 2024-03-13 name: ProGen. Co., Ltd. class: OTHER briefSummary: This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, combined single (Part A) multiple (Part B) ascending dose, phase 1 study to investigate the safety, tolerability and pharmacokinetic and pharmacodynamics following subcutaneous injections of PG-102(MG12) in healthy adult participants.

This study will be conducted in 2 Parts (Part A and B), with up to 5 cohorts in each part (Part A; Cohorts A1 to A5 and Part B; Cohorts B1 to B5). conditions: Healthy conditions: Overweight studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: PG-102(MG12) name: Placebo measure: Number of participants with treatment-emergent adverse events (TEAEs) for Part A measure: Number of participants with treatment-emergent adverse events (TEAEs) for Part B measure: Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part A measure: Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part B measure: Number of participants with clinically significant abnormalities in vital signs for Part A measure: Number of participants with clinically significant abnormalities in vital signs for Part B measure: Number of participants with clinically significant abnormalities in 12-lead ECGs for Part A measure: Number of participants with clinically significant abnormalities in 12-lead ECGs for Part B measure: Maximum plasma concentration (Cmax) for Part A measure: Maximum plasma concentration (Cmax) for Part B measure: Time to maximum plasma concentration (tmax) for Part A measure: Time to maximum plasma concentration (tmax) for Part B measure: Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part A measure: Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part B measure: Terminal half-life (t1/2) for Part A measure: Terminal half-life (t1/2) for Part B measure: Apparent total clearance (CL/F) for Part A measure: Apparent total clearance (CL/F) for Part B sex: ALL minimumAge: 19 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Catholic University Seoul St.Mary Hospital, status: RECRUITING city: Seocho state: Seoul zip: 06591 country: Korea, Republic of name: Kyunghwa Son, Ph.D role: CONTACT phone: 02-6098-2818 email: bd@progen.co.kr lat: 37.49056 lon: 127.02 hasResults: False

 nctId: NCT06309654 id: PNU briefTitle: Home-Based Circuit Training in Overweight/Obese Older Adult Patients With Knee Osteoarthritis and Type 2 Diabetes overallStatus: COMPLETED date: 2021-09-13 date: 2023-09-13 date: 2023-12-29 date: 2024-03-13 date: 2024-03-13 name: Princess Nourah Bint Abdulrahman University class: OTHER briefSummary: Background: Obesity and type 2 diabetes mellitus (T2DM) are considered two of the most prevalent metabolic diseases linked to the onset of knee pain caused by osteoarthritis. Regular exercise has been documented as a principal component of a prevention, management, and treatment strategy for knee osteoarthritis (KOA) patients. However, evidence-based exercise protocols for individuals with comorbidities such as obesity, T2DM, and KOA are scarce. Thus, the present pragmatic randomized controlled trial aimed to investigate the effectiveness of a 12-week home-based circuit training (HBCT) protocol on various indicators related to KOA and cardiometabolic health among overweight/obese older adult patients with KOA and T2DM during the COVID-19 lockdown. Methods: Seventy overweight or obese patients with KOA and T2DM (62.2 ± 6.1 years; 56% female) were randomly assigned to the intervention group (n = 35, HBCT) or the no-exercise control group (n = 35, CON). HBCT performed a progressive protocol (seven exercises; 15-30 repetitions per exercise, 1 min passive rest between exercises; 2-4 rounds per session; 20-60 min total session duration). The knee injury and osteoarthritis symptoms, cardiovascular and metabolic risk factors, cardiorespiratory fitness, and renal function were assessed at baseline and following the 12-week intervention. Results: HBCT significantly improved HBCT improved the vast majority of outcomes related to cardiometabolic health and knee osteoarthritis symptoms compared to CON (p\<0.05). No significant differences were detected in total bilirubin, sodium, urea, resting heart rate, or KOOS-sport between HBCT and CON. Conclusion: These findings suggest that an injury-free HBCT program may improve several cardiometabolic health- and KOA-related indices in overweight/obese patients with T2DM and KOA. Such results may encourage clinicians and practitioners to adopt real-world exercise training approaches when prescribing physical exercise to patients characterized by impaired metabolic and musculoskeletal health. conditions: Aerobic Exercise conditions: Strength Training conditions: Glycemic Control conditions: Blood Pressure conditions: Oxidative Stress conditions: Metabolic Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Seventy overweight or obese patients with KOA and T2DM (62.2 ± 6.1 years; 56% female) were randomly assigned to the intervention group (n = 35, HBCT) or the no-exercise control group (n = 35, CON). HBCT performed a progressive protocol (seven exercises; 15-30 repetitions per exercise, 1 min passive rest between exercises; 2-4 rounds per session; 20-60 min total session duration). The knee injury and osteoarthritis symptoms, cardiovascular and metabolic risk factors, cardiorespiratory fitness, and renal function were assessed at baseline and following the 12-week intervention. primaryPurpose: TREATMENT masking: NONE count: 70 type: ACTUAL name: 12-week home-based circuit training (HBCT) name: Standard of care (CONT) measure: Blood pressure measure: The A1C test measure: blood oxygen levels measure: cardiorespiratory fitness measure: interleukin 6 (IL-6) measure: Superoxide dismutases (SOD) sex: ALL minimumAge: 55 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Princess Nourah bint Abdulrahman University city: Riyadh zip: 11671 country: Saudi Arabia lat: 24.68773 lon: 46.72185 hasResults: False

 nctId: NCT06309641 id: MetHb 001 briefTitle: Methemoglobinemia Following Intravenous Iron Treatment overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-12 date: 2025-12 date: 2024-03-13 date: 2024-03-19 name: Claudia Seiler class: OTHER briefSummary: Methemoglobinemia as a side effect of treatment with intravenous iron has not previously been described. This study aims to assess methemoglobin levels in patients with anemia following treatment with intravenous iron, administered as ferric carboxymaltose or ferric derisomaltose. conditions: Methemoglobinemia conditions: Anemia conditions: Iron Deficiencies conditions: Side Effect studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Blood sample after treatment name: Case reports measure: Difference in methemoglobin after ferric derisomaltose measure: Difference in methemoglobin after ferric carboxymaltose measure: Difference in methemoglobin depending on drug dosage measure: Difference in methemoglobin depending on age measure: Difference in methemoglobin depending on sex measure: Difference in methemoglobin depending on hemoglobin level before treatment measure: Difference in methemoglobin depending on blood levels of ferritin, transferrin or iron. measure: Association between difference in methemoglobin and venous lactate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center of Clinical Research Dalarna city: Falun zip: 79182 country: Sweden name: Claudia Seiler, MD role: CONTACT phone: +46 70 2896416 email: claudia.seiler@regiondalarna.se lat: 60.60357 lon: 15.62597 hasResults: False

 nctId: NCT06309628 id: PGX-006 briefTitle: Analysis of Volatile Organic Compounds in the Breath of Lung Transplant Rejection Patients Using Infrared Spectroscopy overallStatus: ENROLLING_BY_INVITATION date: 2023-09-21 date: 2024-07-31 date: 2024-12-31 date: 2024-03-13 date: 2024-03-13 name: Paragonix Technologies class: INDUSTRY name: Picomole Inc briefSummary: This study will sample and analyze volatile organic compounds (VOCs) from participants considered to be at risk for developing rejection following lung transplant by using infrared spectroscopy. conditions: Lung Transplant Rejection studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED name: Breathe sample measure: Volatile Organic Compound profile sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duke University city: Durham state: North Carolina zip: 27710 country: United States lat: 35.99403 lon: -78.89862 hasResults: False

 nctId: NCT06309615 id: PDX-001_2 briefTitle: Decision Impact Study of PreciseDx Breast acronym: PDxBRUTILITY overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-05-30 date: 2029-05-30 date: 2024-03-13 date: 2024-03-13 name: Precise Dx, Inc. class: INDUSTRY name: The Cleveland Clinic briefSummary: The investigator's developed a digital LDT to predict invasive breast cancer (IBC) recurrence within 6 years by combining histologic features extracted from an H\&E image of the patients IBC with clinical data including the patients age, tumor size, stage and number of positive lymph nodes. The development of an artificial-intelligent (AI)-grade provides not only an objective, quantitative advancement of classical breast cancer grading but also improves upon the accuracy and utility of clinical risk. The investigator's sought to understand how such a PreciseDx Breast would be used in clinical practice post-surgical resection for women with early-stage IBC. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Standard of Care measure: Decision Impact Study of PreciseDx Breast on treating Oncologist measure: Decision Impact Study of PreciseDx Breast on Diagnostic Pathologist measure: Decision Impact on long term outcomes sex: FEMALE minimumAge: 23 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06309602 id: 22-0465 briefTitle: Investigation of a Free Water Protocol overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2028-01-01 date: 2028-01-01 date: 2024-03-13 date: 2024-03-13 name: Poudre Valley Health System class: OTHER briefSummary: Hypothesis: Use of a Free Water Protocol (FWP) will improve patient satisfaction scores (Dysphagia Handicap Index), will not increase the risk of aspiration pneumonia/pneumonitis, and will result in improved oral hygiene (as assessed by the Oral Assessment Guide). Aim: To demonstrate that improvement in patient satisfaction and quality of life scores outweighs the potential risks of aspiration of plain water in an acute care setting; to qualitatively assess the implementation of a Free Water Protocol from the viewpoints of the patient and family/caregivers; to quantify changes in oral hygiene practices for individuals on the Free Water Protocol. conditions: Oropharyngeal Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 136 type: ESTIMATED name: Free Water Protocol name: Control / Standard Care measure: Dysphagia Handicap Index measure: Oral Assessment Guide measure: Qualitative data measure: Adverse events: Aspiration pneumonia/pneumonitis measure: Liquid intake sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Center of the Rockies city: Loveland state: Colorado zip: 80538 country: United States name: Emily Main, MS, CCC-SLP role: CONTACT phone: 970-624-4369 email: emily.main@uchealth.org name: Brian Daily, MD role: SUB_INVESTIGATOR name: Cordelie Witt, MD role: SUB_INVESTIGATOR name: Lucie Uncapher, MD role: SUB_INVESTIGATOR name: Brandon Petrun, MD role: SUB_INVESTIGATOR lat: 40.39776 lon: -105.07498 hasResults: False

 nctId: NCT06309589 id: YIHM briefTitle: The Effectiveness of Combining Ursodeoxycholic Acid With Vitamin D in Treating Patients With Primary Biliary Cholangitis overallStatus: COMPLETED date: 2021-05-01 date: 2023-09-30 date: 2023-12-31 date: 2024-03-13 date: 2024-03-13 name: Yilihamu·Abilitifu class: OTHER briefSummary: The goal of this clinical trial is to compare in the effectiveness of combining ursodeoxycholic acid and vitamin D in treating patients with primary biliary cholangitis. conditions: Primary Biliary Cholangitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: Vitamin D measure: UDCA response: Paris I criteria measure: UDCA response: Barcelona criteria sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: People's Hospital of Xinjiang Uygur Autonomous Region city: Urumqi state: Xinjiang zip: 830001 country: China lat: 43.80096 lon: 87.60046 hasResults: False

 nctId: NCT06309576 id: PBRC 2023-069 briefTitle: Experimental Approach to Test Predictions of Body Weight Regulation Models acronym: DIP overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-11 date: 2025-02 date: 2024-03-13 date: 2024-03-13 name: Pennington Biomedical Research Center class: OTHER name: Tulane University briefSummary: The regulation of human body weight and fatness is not fully understood. Although some models of regulation have been proposed (set point, dual-intervention point, others), no studies have been designed to test their predictions. In this pilot and feasibility study, the investigators will implement an experimental approach to test the predictions of models of body weight regulation in humans. Men and women with either underweight or obesity will be exposed to a 2-day fasting followed by a 2-day ad-libitum refeeding. During the entire fasting-refeeding period, energy intake and expenditure will be accurately measured within metabolic chambers. The investigators will therefore determine the compensatory responses to fasting elicited to prevent weight loss. The results will serve to design and power future studies to better understand body weight regulation. conditions: Obesity conditions: Underweight studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 12 type: ESTIMATED name: Fasting-refeeding cycle measure: Compensatory response measure: Timing of the compensatory response measure: Protein balance measure: Carbohydrate balance measure: Lipid balance measure: Overall appetite measure: Food preference measure: Physical activity measure: Sleeping metabolic rate measure: Leptin measure: Appetite-regulating hormones measure: Metabolites measure: Gonadotrophic axis measure: Thyroid axis measure: Hypothalamic-pituitary-adrenal axis sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06309563 id: 31J301 briefTitle: Metabolic Effects of a Diet Replaced With Essential Amino Acids acronym: AMINOB overallStatus: RECRUITING date: 2023-08-30 date: 2025-12-31 date: 2025-12-31 date: 2024-03-13 date: 2024-03-15 name: Istituto Auxologico Italiano class: OTHER briefSummary: The effectiveness of low-protein diets supplemented with essential aminoacid (EAA) formulas in genetic disorders of amino acid (AA) catabolism, such as maple syrup urine disease (MSUD), is widely recognized (Blackburn PR et al. 2017). The main aim of the present study is to evaluate a difference in the effectiveness of a multidisciplinary rehabilitation program in patients with high degree of obesity with and without supplementation of this new formula of amino acids (essential + tricarboxylic acids - EAA-AC). For this reason, patients of both sexes, aged between 45 and 65, suffering from high-grade obesity will be recruited in Piancavallo. The enrolled patients divided, randomly, into two groups will be given: EAA-AC group a low-calorie and low-protein diet integrated with 4 sachets of EAA-AC supplement per day; the control group will follow a low-calorie and low-protein diet only with placebo. The parameters considered, after two weeks of treatment, will be: weight loss; the maintenance/recovery of muscle mass assessed through changes in body composition and functional tests (Hand grip, 6MWT or TUG) but also through the analysis of mitochondrial function in PBMC and circulating levels of mtDNA; the improvement of the glucose picture and the lipid profile.

1 month after discharge, patients will carry out an outpatient check-up to evaluate the maintenance of muscle mass using impedance testing. conditions: Obesity Morbid conditions: Weight Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Aminoacid supplementation name: Placebo measure: Muscle mass measure: 6 minute walking test (6MWT) sex: ALL minimumAge: 45 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano, Site Piancavallo status: RECRUITING city: Oggebbio state: Verbania zip: 28921 country: Italy name: Amelia Brunani, MD role: CONTACT phone: 390323514232 email: brunani@auxologico.it lat: 45.99088 lon: 8.64663 hasResults: False

 nctId: NCT06309550 id: 09W002 briefTitle: Provocative Tests for HFpEF acronym: TEST-PEF overallStatus: RECRUITING date: 2023-03-10 date: 2028-03 date: 2028-03 date: 2024-03-13 date: 2024-03-13 name: Istituto Auxologico Italiano class: OTHER briefSummary: Diagnosing heart failure with preserved ejection fraction (HFpEF) in patients complaining exertional breathlessness can be challenging: diagnostic algorithms and scores have low sensitivity, and ageing-associated comorbidities can complicate the interpretation of symptoms. Thus, exercise right heart catheterization (RHC) or invasive cardiopulmonary exercise test (iCPET) have been advocated as gold-standard methods for HFpEF diagnosis. However, exercise RHC and iCPET are still not widely standardized methods, with results mainly coming from US cohorts (that may differ from Italian cohorts), and other provocative tests (e.g. non-invasive CPET, passive leg raising) may offer complementary diagnostic information. conditions: Heart Failure With Preserved Ejection Fraction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: exercise test measure: Mortality measure: Hospitalization for heart failure measure: Atrial fibrillation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale San Luca IRCCS Istituto Auxologico Italiano status: RECRUITING city: Milan zip: 20149 country: Italy name: Sergio Caravita, MD, PhD role: CONTACT phone: +39 02 61911 2930 email: s.caravita@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06309537 id: 09C830 briefTitle: Chemoreflex Sensitivity in HFpEF acronym: CHEMO-HFpEF overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2029-12 date: 2029-12 date: 2024-03-13 date: 2024-03-13 name: Istituto Auxologico Italiano class: OTHER briefSummary: Patients with heart failure and a preserved left ventricular ejection fraction (HFpEF) almost invariably complain of exertional breathlessness. Abnormal cardiac hemodynamics with pulmonary congestion are believed to trigger dyspnea in this patients. However, some patients may complain of exertional breathlessness which seems to be out of proportion as compared with hemodynamic abnormalities.

Chemoreflex sensitivity accounts for the ventilatory responses to a variety of chemical stimuli, including carbon dioxide produced by the organism during exercise. Chemoreflex sensitivity can be augmented in heart failure with reduced left ventricular ejection fraction, and an increased chemoreflex sensitivity has been linked to symptoms, neurohumoral activation, breathing disturbances, and adverse prognosis.

However, the clinical correlates and implications of chemoreflex sensitivity in HFpEF have not been accurately studied.

We aim to characterize chemoreflex sensitivity in patients with a diagnosis of HFpEF, and to correlate chemoreflex sensitivity with clinical and hemodynamic characteristics. conditions: Heart Failure With Preserved Ejection Fraction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: chemoreflex evaluation measure: difference in chemoreflex sensitivity between HFpEF and healthy controls sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale San Luca IRCCS Istituto Auxologico Italiano city: Milan zip: 20149 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06309524 id: 09C332 briefTitle: Assessing the Right Heart Remodeling After Transcatheter Tricuspid Edge-to-edge Repair acronym: HERITAGE overallStatus: RECRUITING date: 2023-02-15 date: 2025-01-01 date: 2025-01-01 date: 2024-03-13 date: 2024-03-13 name: Istituto Auxologico Italiano class: OTHER briefSummary: In the recent years, secondary tricuspid regurgitation (STR) has gained interest due to its high prevalence and impact on outcomes. Transcatheter tricuspid valve replacement or repair represents novel and less invasive alternatives to surgery and has shown early promising results. Treatment options mimic surgical techniques such as leaflet approximation, direct annuloplasty, and heterotopic caval valve implantation, as well as not yet commercially available transcatheter TV replacement systems using orthotopic valve implantation. (5) Among leaflet approximation techniques, the Tricuspid transcatheter edge-to-edge repair (T-TEER) using the TriClip™ (Abbott Vascular, Santa Clara, CA, USA) or leaflet approximation with the PASCAL systems (Edwards Lifesciences, Irvine, CA, USA) are approved in Europe for minimally invasive TV repair.The purposes of the present study are: i. to use 3DE and CCT to evaluate the effect of T-TEER on the geometry and function of the right heart chambers in patients with STR; ii. to identify the predictors of procedural success potentially related to features of both right chambers geometry and TR jet; iii. to compare the accuracy of 3DE assessment of the right ventricle, the right atrium, and the tricuspid annulus, with the same parameters obtained by CCT, in the setting of T-TEER; and iv. to assess patients' outcome. conditions: Tricuspid Regurgitation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 17 type: ESTIMATED name: Tricuspid transcatheter edge-to-edge repair measure: Inverse remodeling of right heart chambers measure: Heart failure hospitalization measure: Death sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano status: RECRUITING city: Milan state: Lombardia zip: 20149 country: Italy name: Michele Tomaselli role: CONTACT phone: +3902619112992 email: michetomaselli@gmail.com lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06309511 id: 09C218 briefTitle: Subendocardial Viability Ratio in Hypertension acronym: SEVR-HT overallStatus: RECRUITING date: 2022-10-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-13 date: 2024-03-13 name: Istituto Auxologico Italiano class: OTHER briefSummary: The aim of the research is to evaluate the Subendocardial Viability Ratio (SEVR) in hypertensive patients, using non-invasive arterial tonometry, and to establish the influencing factors and the possibility of predicting cardiovascular morbidity and mortality in arterial hypertension.

The SEVR will be evaluated on all patients belonging to the Arterial Hypertension Centers undergoing non-invasive arterial tonometry.

The SEVR is calculated on the morphology of the central pressure wave as the ratio between the DPTI (diastolic pressure-time index), i.e. the area between the carotid pressure curve and the ventricular pressure curve during the diastolic phase, and the SPTI ( systolic pressure-time index), i.e. the area under the carotid pressure curve during the systolic phase.

The SEVR will be correlated with the anthropometric and pathology variables which will be collected in an appropriate database. conditions: Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED name: Arterial tonometry measure: Buckberg index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro di Prevenzione e Cura dell'Ipertensione Arteriosa "Alessandro Filippi" status: RECRUITING city: Mascalucia state: Catania country: Italy name: Antonino Di Guardo, MD role: CONTACT email: ninodiguardo58@gmail.com name: Massimo Catanuso, MD role: CONTACT email: catanusomassimo@hotmail.it lat: 37.57465 lon: 15.04964 facility: Unità Operativa Semplice Dipartimentale Ipertensione Arteriosa "Anna Maria Pirrelli", Università degli Studi di Bari "Aldo Moro". Policlinico Consorziale di Bari status: RECRUITING city: Bari country: Italy name: Pietro Nazzaro, MD role: CONTACT email: pietro.nazzaro@uniba.it name: Sebastiano Cicco, MD role: CONTACT email: sebastiano.cicco@uniba.it lat: 41.11148 lon: 16.8554 facility: Istituto Auxologico Italiano IRCCS status: RECRUITING city: Milano zip: 20145 country: Italy name: Paolo Salvi, MD role: CONTACT phone: +390261911 phoneExt: 2968 email: p.salvi@auxologico.it lat: 45.46427 lon: 9.18951 facility: Medicina II Cardiovascolare, AUSL-IRCCS di Reggio Emilia status: RECRUITING city: Reggio Emilia country: Italy name: Angelo Ghirarduzzi, MD role: CONTACT email: ghirarduzzi.angelo@ausl.re.it name: Chiara Grasselli, MD role: CONTACT email: chiara.grasselli@ausl.re.it lat: 44.69825 lon: 10.63125 facility: Dipartimento di Scienze Mediche, Chirurgiche e della Salute, Università degli studi di Trieste status: RECRUITING city: Trieste country: Italy name: Andrea Grillo, MD role: CONTACT email: andr.grillo@gmail.com name: Bruno Fabris, MD role: CONTACT email: b.fabris@fmc.units.it lat: 45.64953 lon: 13.77679 hasResults: False

 nctId: NCT06309498 id: 05C307 briefTitle: Residual Adrenal Function in Addison's Disease acronym: ADD-RES overallStatus: RECRUITING date: 2023-01-01 date: 2024-10-30 date: 2024-12-31 date: 2024-03-13 date: 2024-03-13 name: Istituto Auxologico Italiano class: OTHER briefSummary: The main aim of this study is to assess the role of 11-deoxycortisol as surrogate marker of Residual adrenal function.

11-deoxycortisol levels will be assessed in all recruited patients conditions: Adrenal Insufficiency studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: blood test measure: prevalence of RAF measure: prevalence of adrenal crisis sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano status: RECRUITING city: Milan zip: 20135 country: Italy name: Valentina Morelli role: CONTACT phone: 02619112547 email: v.morelli@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06309485 id: WGI0301-P2G-01 briefTitle: Phase 2 Study of WGI-0301 in Combination With Sorafenib for Advanced HCC overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-08 date: 2026-12 date: 2024-03-13 date: 2024-03-13 name: Zhejiang Haichang Biotech Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to determine the MTD of WGI-0301 in combination with Sorafenib for advanced Hepatocellular Carcinoma (HCC) and assess its safety and efficacy in adults with advanced unresectable HCC who have previously received PD-1 / PD-L1 immune checkpoint inhibitors. conditions: Advanced Hepatocellular Carcinoma (HCC) studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: WGI-0301 at MTD/RP2D dose IV infusion, QW name: WGI-0301 at MTD/RP2D -1 dose IV infusion, QW name: Sorafenib 400 mg PO, BID continuously name: Sorafenib 400 mg PO, BID measure: Efficacy of WGI-0301 in combination with Sorafenib based on ORR per RECIST 1.1. measure: Safety of each dose group. measure: Tolerability of each dose group. measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on ORR. measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on DCR. measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on DoR. measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on PFS. measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on TTP per RECIST 1.1. measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on OS. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06309472 id: NIHR302528 briefTitle: Trial of Mirtazapine for Depression in IBD acronym: MDIBD overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-02 date: 2026-06 date: 2024-03-13 date: 2024-03-13 name: King's College London class: OTHER name: King's College Hospital NHS Trust name: Imperial College London name: London North West Healthcare NHS Trust name: Imperial College Healthcare NHS Trust name: Guy's and St Thomas' NHS Foundation Trust briefSummary: This study will test whether it is feasible to conduct a clinical trial of mirtazapine (an antidepressant tablet) in patients who have both depression and inflammatory bowel disease (IBD). The study design is a randomised controlled trial (a study in which people are allocated by chance to receive different interventions). The trial will compare mirtazapine against a placebo (dummy) tablet in 76 patients with both depression and IBD.

The investigators will recruit outpatients aged 18 or over with a diagnosis of any IBD attending gastroenterology clinics. Either in person or remotely, patients will complete a brief screening questionnaire for depression. Those scoring positive for depression will be invited for a 15-minute interview for clinical depression. Those with clinical depression will be invited to take part. Participants will be randomly allocated by a computer to take either 1) mirtazapine tablet once at night for 12 weeks; or 2) placebo (dummy) tablet once at night for 12 weeks. The study is 'blinded', meaning neither patients nor the study team will know which medication they are taking. Throughout, participants will be able to access other treatments for depression, such as talking therapies.

The investigators will measure how many people join the study; how many remain in the trial; how many complete treatment; how many tablets people take; and assess overall acceptability of the trial. Participants will complete brief questionnaires to measure their mental health and IBD symptoms after 4 weeks, 8 weeks, 12 weeks and 16 weeks. Participants will also provide blood samples and faecal samples to measure inflammation.

If successful, this trial will support an application for a larger version of the study. conditions: Major Depressive Disorder conditions: Inflammatory Bowel Diseases studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Mirtazapine and placebo manufactured to appear identical through over-encapsulation whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: Mirtazapine name: Placebo measure: Recruitment feasibility measure: Trial adherence measure: Treatment adherence measure: Study procedures acceptability and compliance measure: Overall acceptability measure: Quick Inventory for Depressive Symptomatology-16 Questionnaire measure: Patient Health Questionnaire-9 questionnaire measure: Generalised Anxiety Disorder-7 questionnaire measure: Inflammatory Bowel Disease Control questionnaire measure: Inflammatory Bowel Disease Fatigue Assessment Scale measure: Chalder Fatigue Scale measure: Maudsley 3-item Visual Analogue Scale measure: Pittsburgh Sleep Quality Index measure: 9-item Avoidant Restrictive Food Intake Disorder Screen measure: Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) Questionnaire measure: Inflammatory Bowel Disease Resource Use Questionnaire (IBD-RUQ) items on employment and healthcare contacts measure: Birmingham Irritable Bowel Syndrome Symptoms Questionnaire measure: Harvey Bradshaw Index (Crohn's disease patients only) measure: Simple Clinical Colitis Activity Index (ulcerative colitis patients only) measure: Dietary Screener Questionnaire measure: Concentration of faecal calprotectin measure: Concentration of serum high-sensitivity C-reactive protein measure: Concentration of serum interleukin-23 measure: Concentration of serum interleukin-22 measure: Concentration of serum granulocyte-macrophage colony-stimulating factor measure: Concentration of serum interleukin-5 measure: Concentration of serum interleukin-13 measure: Concentration of serum interleukin-17A measure: Concentration of serum tumor necrosis factor alpha measure: Concentration of serum interferon-gamma sex: ALL minimumAge: 18 Years maximumAge: 125 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06309459 id: IRB 2023/04-34 briefTitle: Carbonic Anhydrase IX Enzyme in Triple Negative Breast Carcinoma overallStatus: COMPLETED date: 2018-08-01 date: 2023-05-01 date: 2023-05-01 date: 2024-03-13 date: 2024-03-13 name: Kahramanmaras Sutcu Imam University class: OTHER briefSummary: Triple-negative breast carcinoma is characterized by the absence of estrogen receptors, progesterone receptors, and HER2/neu receptors. Carbonic anhydrase IX (CA IX) is a tumor-associated cell surface glycoprotein that is involved in adaptation to hypoxia-induced acidosis and plays a role in cancer progression. This study aimed to investigate CA IX expression in TNBC and its relationship with treatment effect. conditions: Triple Negative Breast Cancer conditions: Carbonic Anhydrase IX studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 40 type: ACTUAL name: Carbonic anhydrase staining levels measure: Poor prognostic factors in patients with TNBC measure: The treatment success with inhibiting the CA IX enzyme levels' effectiveness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kahramanmaraş Sütçü İmam University city: Kahramanmaraş zip: 46000 country: Turkey lat: 37.5847 lon: 36.92641 hasResults: False

 nctId: NCT06309446 id: 381001BS briefTitle: Assessment of Wound Healing, Cooling Efficacy and Local Tolerability of a Wound Care Hydrogel overallStatus: COMPLETED date: 2020-01-14 date: 2020-02-19 date: 2020-07-02 date: 2024-03-13 date: 2024-03-13 name: Oystershell NV class: INDUSTRY name: Bioskin GmbH briefSummary: Test the wound healing properties of the product as well as the cooling effect and tolerability of a wound care gel. conditions: Wound studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 33 type: ACTUAL name: Zoralan Wound measure: Wound healing efficacy (clinical) measure: Wound healing efficacy (global) measure: Cooling properties measure: Local tolerability (clinical) measure: Local tolerability (global) measure: Signs of infection measure: Time until 100% healing measure: Time until 75% healing measure: Presence of crusts measure: Questionnaire on product performance measure: Cosmetic outcome/acceptance measure: Photographic documentation of the wound - visual of the wound to support previous outcomes. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bioskin GmbH city: Hamburg zip: 20095 country: Germany lat: 53.57532 lon: 10.01534 hasResults: False

 nctId: NCT06309433 id: DXA-TKA briefTitle: Assessment of Periprosthetic Bone Mineral Density in Patients Undergoing Total Knee Prosthesis of Different Design acronym: DXA-TKA overallStatus: RECRUITING date: 2023-08-30 date: 2027-12 date: 2028-04 date: 2024-03-13 date: 2024-03-13 name: Istituto Ortopedico Rizzoli class: OTHER briefSummary: compare changes in BMD via DXA at the level of the femoral and tibial periprosthetic bone between two groups of patients undergoing cemented TKA of different design (posterior stabilization vs posterior cruciate preservation) with proms at a 2-year follow-up. conditions: Periprosthetic Osteolysis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: dual energy x-ray absorptiometry measure: Periprosthetic bone mineral density measurement measure: Periprosthetic bone mineral density measurement measure: Periprosthetic bone mineral density measurement measure: Periprosthetic bone mineral density measurement measure: Knee Society Score measure: Knee Society Score measure: Knee Society Score measure: Knee Society Score measure: Western Ontario and McMaster Universities Arthritis Index measure: Western Ontario and McMaster Universities Arthritis Index measure: Western Ontario and McMaster Universities Arthritis Index measure: Western Ontario and McMaster Universities Arthritis Index measure: Knee injury and Osteoarthritis Outcome Score measure: Knee injury and Osteoarthritis Outcome Score measure: Knee injury and Osteoarthritis Outcome Score measure: Knee injury and Osteoarthritis Outcome Score measure: 36-Item Short Form Health Survey measure: 36-Item Short Form Health Survey measure: 36-Item Short Form Health Survey measure: 36-Item Short Form Health Survey sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stefano Zaffagnini status: RECRUITING city: Bologna state: Italia country: Italy name: Stefano Zaffagnini, MD role: CONTACT phone: 051 6366075 email: stefano.zaffagnini@unibo.it lat: 44.49381 lon: 11.33875 facility: Istituto ortoepdico rizzoli status: RECRUITING city: Bologna zip: 40136 country: Italy name: Stefano Zaffagnini, Prof. role: CONTACT phone: 00390516366111 email: stefano.zaffagnini@unibo.it lat: 44.49381 lon: 11.33875 hasResults: False

 nctId: NCT06309420 id: 19E0566 briefTitle: Clinical Trial to Evaluate Efficacy and Safety of a Cryogenic Medical Device for Treatment of Common and Plantar Warts overallStatus: COMPLETED date: 2019-11-07 date: 2020-08-10 date: 2020-08-10 date: 2024-03-13 date: 2024-03-13 name: Oystershell NV class: INDUSTRY briefSummary: The present study was set-up to evaluate clinical efficacy of Pixie CO2 versus a comparator product (Wortie®) for the treatment of common and plantar warts. conditions: Warts studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Investigator-blinded, Randomized,Tested product versus comparator (benchmark product), In parallel groups, With multiple applications, Single centre. primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 54 type: ACTUAL name: Cryogenic treatment of warts (Pixie CO2) name: Cryogenic treatment of warts (Wortie®) measure: Percentage of subjects with clinical wart remission measure: Number of treatments measure: Efficacy of the freezing process (Surface Area) measure: Diameter of the wart measure: Roughness of the wart measure: Thickness of the wart (For common warts only) measure: Presence of small dark spot (For plantar warts only) measure: Healing process of the wart measure: Local & general tolerance sex: ALL minimumAge: 4 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Dermscan Poland city: Gdansk zip: 80-288 country: Poland lat: 54.35205 lon: 18.64637 hasResults: False

 nctId: NCT06309407 id: STUDY00024903 briefTitle: Dosimeter Location in Pain Physicians overallStatus: COMPLETED date: 2022-09-23 date: 2023-04-21 date: 2023-04-21 date: 2024-03-13 date: 2024-03-13 name: Oregon Health and Science University class: OTHER briefSummary: The primary objective is to determine if there is a significant difference in radiation readings between dosimeters worn on the chest versus the hand of interventional pain management physicians and elucidate which dosimeter had higher readings.

The secondary objective is to track incidences of physician glove breaches in both groups to assess if wearing hand dosimeters is associated with an increased risk of this event. conditions: RAD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants were randomized to wear either chest dosimeters only or chest and hand dosimeters for the duration of the study in order to measure differences in radiation readings by each dosimeter location. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 10 type: ACTUAL name: Hand Dosimeters name: Standard Practice measure: Radiation Readings measure: Number of Glove Breach Events sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oregon Health & Science University city: Portland state: Oregon zip: 97239 country: United States lat: 45.52345 lon: -122.67621 hasResults: False

 nctId: NCT06309394 id: INCB99280-102 briefTitle: A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-06-03 date: 2024-06-03 date: 2024-03-13 date: 2024-03-13 name: Incyte Corporation class: INDUSTRY briefSummary: This study is being conducted to assess the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of \[14C\]INCB099280 in Healthy Male Participants. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 7 type: ESTIMATED name: INCB099280 measure: Total recovery of radioactivity from urine and feces. measure: Percentage of total radioactive dose in Plasma, Urinary and Fecal Excretion measure: Pharmacokinetic (PK) in Plasma measure: PK for whole blood and plasma total radioactivity measure: Number of participants with Treatment Emergent Adverse Events (TEAEs) sex: MALE minimumAge: 35 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06309381 id: CEIm2.23 briefTitle: Influence of Sensory Block Duration on Rebound Pain After Outpatient Foot Surgery Under Popliteal Sciatic Nerve Block. overallStatus: RECRUITING date: 2023-02-08 date: 2024-10 date: 2024-10 date: 2024-03-13 date: 2024-03-13 name: Hospital Universitario Doctor Peset class: OTHER briefSummary: Rebound pain after surgeries under peripheral nerve block is defined as the appearance of severe acute postoperative pain after regression of the sensory block. The incidence of this condition can reach up to 40-50% in patients undergoing ambulatory surgeries. Rebound pain represents a clinically significant issue that may outweigh the benefits of regional anaesthesia. This is particularly significant for painful outpatient surgeries, where inadequately managed pain can result in distress, potentially affecting patient satisfaction and recovery. It may also lead to unplanned utilization of healthcare resources or readmissions.

Orthopaedic foot surgery is a prevalent outpatient surgery, potentially painful, where rebound may be a difficult challenge. However, to date, prospective studies focusing specifically on rebound pain in outpatient foot surgery are limited. Identifying conditions associated with rebound pain or at-risk patients could facilitate the development of preventive and treatment strategies, thereby enhancing pain management or relief. Younger age, female sex and bone surgery are non-modifiable factors associated with severe rebound pain. Perioperative intravenous dexamethasone has been identified as a modifiable independent risk factor associated with a reduced incidence of rebound pain. Regarding anaesthetic factors, the duration of the peripheral block has been proposed as a potentially modifiable factor influencing rebound pain; however, current evidence does not support this hypothesis.

The goal of this prospective observational study is to evaluate the incidence of rebound pain specifically in outpatient orthopaedic foot surgery involving bone under popliteal sciatic nerve block and to assess the possible association between sensory block duration and the incidence of rebound pain. conditions: Rebound Pain conditions: Sciatic Nerve Block conditions: Foot Surgery conditions: Outpatient Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Incidence of rebound pain. measure: Sensory block duration of the sciatic nerve block. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Av. de Gaspar Aguilar, 90 status: RECRUITING city: Valencia zip: 46017 country: Spain name: Javier Barrio, MD, PhD role: CONTACT phone: 0034646819882 email: jbarrio.ma@gmail.com name: Javier Barrio, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06309368 id: 003875 briefTitle: Ostomy Primary Closure With 0.1% Betaine/0.1% Polyhexanide Wound Irrigation Compared to Pursestring Closure overallStatus: RECRUITING date: 2024-03-14 date: 2024-12 date: 2025-12 date: 2024-03-13 date: 2024-03-25 name: University of Nevada, Las Vegas class: OTHER briefSummary: The goal of this clinical trial is to compare two types of closure in patients with ostomies that are ready for closure. The main questions it aims to answer are:

1. Surgical site infection rates
2. Patient quality of life
3. Time to wound healing

Participants will undergo either complete ostomy wound closure after washing out the wound with Prontosan, or their ostomy wound will be closed using the Pursestring method, where the wound will be left partially open and allowed to heal from the inside out. Researchers will compare these two groups' outcomes (questions to be answered) as listed above. conditions: Surgical Site Infection conditions: Wound Surgical conditions: Colorectal Disorders studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to one of the two treatment groups. primaryPurpose: TREATMENT masking: NONE maskingDescription: No masking. This is a non-blinded randomized controlled trial count: 84 type: ESTIMATED name: Primary Ostomy Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation name: Pursestring Closure measure: Surgical Site Infection Rates measure: Acceptability of wound and scar healing by patient measure: Acceptability of wound and scar healing by patient measure: Acceptability of wound and scar healing by patient measure: Acceptability of wound and scar healing by patient measure: Wound healing sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center status: RECRUITING city: Las Vegas state: Nevada zip: 89102 country: United States name: Abigail W Cheng, MD role: CONTACT phone: 916-695-4159 email: abigail.cheng@unlv.edu name: Lance Horner, MD role: CONTACT phone: 7755445456 email: lance.horner@unlv.edu name: Ovunc Bardakcioglu, MD role: PRINCIPAL_INVESTIGATOR name: Lance Horner, MD role: PRINCIPAL_INVESTIGATOR name: Abigail W Cheng, MD role: SUB_INVESTIGATOR name: Henry Krasner, BS role: SUB_INVESTIGATOR name: Kavita Batra, PhD role: SUB_INVESTIGATOR lat: 36.17497 lon: -115.13722 hasResults: False

 nctId: NCT06309355 id: YR001-A03 briefTitle: Topical YR001 Ointment in Adult With Mild to Moderate Atopic Dermatitis overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-01 date: 2025-06 date: 2024-03-13 date: 2024-03-18 name: Hangzhou Yirui Pharmaceutical Technology Co., Ltd class: INDUSTRY briefSummary: This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in adult patients with mild to moderate atopic dermatitis conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 36 type: ESTIMATED name: YR001 ointment name: Placebo measure: The primary endpoint will be safety. Specifically, the primary endpoint will be the incidence of treatment-related AEs (TRAEs) through Day 50. measure: all treatment-emergents AEs measure: Efficacy of YR001 Ointment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: DelRicht Research city: Baton Rouge state: Louisiana zip: 70809 country: United States name: Ira H Thorla, Doctor role: CONTACT lat: 30.45075 lon: -91.15455 hasResults: False

 nctId: NCT06309342 id: VGRFOU-278257 briefTitle: Prevention of Lifestyle-related Disorders Based on Functional Examinations acronym: PREVFUNKTION overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-12 date: 2026-12 date: 2024-03-13 date: 2024-03-13 name: Lena Bornhoft class: OTHER name: Vastra Gotaland Region name: Göteborg University briefSummary: The goal of this randomised controlled trial is to examine the effects of functional examinations and feedback/support on healthy 40-year-olds. The main questions it aims to answer are: • Does feedback and motivational interviewing after testing physical function motivate inactive middle-aged people to increase their physical activity level? • Does the intervention lead to health benefits over time - less pain, better function, higher health-related quality of life, fewer risk factors for lifestyle-related illness? Participants will: • undergo medical and functional health examinations, • their physical activity level will be measured, • receive feedback and advice based on both parts of the examinations, • receive a functional profile, • be supported in goalsetting for lifestyle changes. Researchers will compare with a control group who, after the examinations, receive feedback only from the medical examination to see if participants become more physically active, achieve better function, become more motivated to make lifestyle changes, reduce risk factors for lifestyle-related illness, achieve health benefits and better health-related quality of life. conditions: Lifestyle-related Condition studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Initial examinations and data collection are made before randomisation. Randomisation then leads to the two groups of participants receiving different amounts of feedback and support. Follow-up examinations and data collection are made after one year in both groups. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Investigators performing the health and function examinations will not be informed about the group to which the participant is allocated. All examinations are performed identically for participants from both groups. whoMasked: INVESTIGATOR count: 250 type: ESTIMATED name: PREVFUNKTION name: Control measure: Change in objectively measured physical activity measure: Change in objectively measured sedentary behaviour measure: Change in cardiovascular fitness measure: Change in motivation level measure: Proportion achieved goals measure: Change in fitness level measure: Change in strength upper extremity measure: Change in strength lower extremity measure: Change in strength trunk muscles measure: Change in balance measure: Change in mobility measure: Change in posture measure: Change in weight measures measure: Change in pain measure: Change in physical activity measure: Change in handgrip strength measure: Change in biceps strength measure: Change in leg strength measure: Change in calf strength measure: Change in ventral trunk strength measure: Change in dorsal trunk strength measure: Change in lower trunk strength measure: Change in static balance - 1 measure: Change in static balance - 2 measure: Change in static balance - 3 measure: Change in dynamic balance measure: Change in mobility - 1 measure: Change in mobility - 2 measure: Change in mobility - 3 measure: Change in hypermobility score measure: Change in neck mobility measure: Change in foot pronation measure: Change in habitual stance measure: Change in health-related quality of life assessed with EQ5D index measure: Change in health-related quality of life assessed with EQ5D VAS measure: Change in self-reported physical activity assessed with Swedish questionnaire measure: Change in self-reported physical activity assessed with Saltin Grimby Physical Activity Level Scale (SGPALS) measure: Change in self-reported sedentary time measure: Change in risk for chronic pain and sickness absence assessed with Örebro Musculoskeletal Pain Screening Questionnaire measure: Change in number of pain locations measure: Change in proportion smokers measure: Change in proportion acceptable level blood glucose measure: Change in proportion acceptable level serum cholesterol measure: Change in proportion acceptable level triglycerides measure: Change in proportion acceptable blood pressure measure: Change in proportion normal body mass index (BMI) measure: Change in proportion acceptable waist circumference measure: Change in stress symptoms assessed with Stress and Crisis Inventory-93 measure: Change in depression and anxiety symptoms assessed with Hospital Anxiety and Depression Scale measure: Correlation between self-assessed and objectively measured fitness measure: Correlation between self-assessed and objectively measured fitness - 2 measure: Correlation between self-assessed and objectively measured strength upper extremity measure: Correlation between self-assessed and objectively measured strength lower extremity measure: Correlation between self-assessed and objectively measured balance measure: Correlation between self-assessed and objectively measured physical activity measure: Correlation between self-assessed and objectively measured physical activity - 2 sex: ALL minimumAge: 39 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06309329 id: 1770023-2 briefTitle: Strength at Home - Parents RCT overallStatus: ENROLLING_BY_INVITATION date: 2024-03-30 date: 2029-05 date: 2029-05 date: 2024-03-13 date: 2024-04-24 name: VISN 17 Center of Excellence class: FED name: United States Department of Defense name: University of Texas at Austin briefSummary: The goal of this clinical trial is to compare the effect of the Strength at Home Parents intervention to treatment as usual in veterans enrolled for care at VA facilities in VISN 17 on parenting stress and parenting behaviors. The participant population will have elevated PTSD symptoms and parent-child functioning difficulties with an index child between the ages of 3-12. The main question\[s\]it aims to answer are: • Does Strength at Home Parents improve parenting stress and parenting behaviors in comparison to a no-treatment control condition? • Are gains maintained over time and is there a gender difference in efficacy? Participants will complete 4 online assessments, and if randomized to the intervention group they will complete an 8 week tele-health group program. If randomized to the control group participants will receive a link to the VA parenting resources website and any referrals they would like to have. Researchers will compare Strength at Home Parents to VA treatment as usual see if the group intervention improves parenting stress and behaviors above and beyond the existing resources. conditions: Parent-Child Relations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Strength at Home Parents name: VA treatment as usual measure: Parenting Stress Index total score measure: Parenting Stress Index total score measure: Parenting Stress Index total score measure: Laxness subscale on the Parenting Scale measure: Laxness subscale on the Parenting Scale measure: Laxness subscale on the Parenting Scale measure: Over reactivity subscale on the Parenting scale measure: Over reactivity subscale on the Parenting scale measure: Over reactivity subscale on the Parenting scale measure: PTSD Symptom Checklist score measure: PTSD Symptom Checklist score measure: PTSD Symptom Checklist score measure: Quick Inventory of Depressive Symptoms measure: Quick Inventory of Depressive Symptoms measure: Quick Inventory of Depressive Symptoms measure: Total Family Problems Score measure: Total Family Problems Score measure: Total Family Problems Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Central Texas Veterans Healthcare System city: Temple state: Texas zip: 76504 country: United States lat: 31.09823 lon: -97.34278 hasResults: False

 nctId: NCT06309316 id: Grace-PCC briefTitle: The Impact of Person Centred Care (PCC) in Grave's Disease overallStatus: RECRUITING date: 2024-03-25 date: 2027-09-30 date: 2028-12-30 date: 2024-03-13 date: 2024-04-26 name: Vastra Gotaland Region class: OTHER_GOV briefSummary: Mental fatigue (MF) is prevalent after Graves' disease (GD), which is the most common form of hyperthyroidism. We have reported that 38% of patients, compared to 11% of control subjects, suffer from MF more than 1 year after successfully reversing of their hyperthyroidism and that MF is an entity of its own, separated from MF combined with anxiety or depression. The brain pathophysiology is unknown and there is no medical treatment, which requires patients to simply adapt to the situation. In the new national guideline for hyperthyroidism (Jan 2023), rehabilitation is recommended, but currently rarely offered to these patients. The problem is significant for patients, as illustrated by frequent media appeals. In this project, we hypothesise that person-centred care (PCC), which promotes positive coping strategies and increases self-efficacy by engaging patients as partners in their own care, improves MF, reduces sick leave, and lowers the recurrence rate of GD. In two work packages (WP), we will:

WP1 Evaluate the effect of PCC eHealth intervention (telephone and digital platform) as an add-on to usual care vs usual care alone in a randomized controlled trial (RCT) of 220 patients on self-efficacy, days of sick-leave (composite score as primary outcome), MF, recurrence rate of disease, coping strategies, perceived stress, quality of life (QoL) and personality.

WP2 Investigate the cost-effectiveness of the intervention

Patients with GD have impaired long-term QoL. PCC could improve long-term outcomes of this autoimmune disease and may apply to other patient groups. This is in line with the societal aim to reduce mental illness. conditions: Graves Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 220 type: ESTIMATED name: Person-centred care (PCC) measure: Composite score of changes measure: General Self-Efficacy Scale (GSE) measure: General Self-Efficacy Scale (GSE) measure: General Self-Efficacy Scale (GSE) measure: General Self-Efficacy Scale (GSE) measure: Days of sick-leave measure: Days of sick-leave measure: Days of sick-leave measure: Days of sick-leave measure: Mental fatigue score measure: Mental fatigue score measure: Mental fatigue score measure: Mental fatigue score measure: Coping Orientations to Problems Experienced (Brief cope) measure: Coping Orientations to Problems Experienced (Brief cope) measure: Coping Orientations to Problems Experienced (Brief cope) measure: Coping Orientations to Problems Experienced (Brief cope) measure: Perceived Stress Scale (PSS-14) measure: Perceived Stress Scale (PSS-14) measure: Perceived Stress Scale (PSS-14) measure: Perceived Stress Scale (PSS-14) measure: Personality Assessment Guardian NEO-FFI-3 measure: Personality Assessment Guardian NEO-FFI-3 measure: Personality Assessment Guardian NEO-FFI-3 measure: Personality Assessment Guardian NEO-FFI-3 measure: Comprehensive psychopathological rating questionnaire (CPRS) measure: Comprehensive psychopathological rating questionnaire (CPRS) measure: Comprehensive psychopathological rating questionnaire (CPRS) measure: Comprehensive psychopathological rating questionnaire (CPRS) measure: Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39) measure: Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39) measure: Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39) measure: Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39) measure: Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). measure: Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). measure: Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). measure: Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). measure: EuroQol- health questionnaire (EQ-5D) measure: EuroQol- health questionnaire (EQ-5D) measure: EuroQol- health questionnaire (EQ-5D) measure: EuroQol- health questionnaire (EQ-5D) measure: Frenchay Activities Index (FAI) measure: Frenchay Activities Index (FAI) measure: Frenchay Activities Index (FAI) measure: Frenchay Activities Index (FAI) measure: Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI) measure: Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI) measure: Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI) measure: Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI) measure: Levels of thyroid autoantibodies measure: Levels of thyroid autoantibodies measure: Levels of thyroid autoantibodies measure: Levels of thyroid autoantibodies measure: Levels of thyroid hormones measure: Levels of thyroid hormones measure: Levels of thyroid hormones measure: Levels of thyroid hormones measure: Clinical Activity Score (CAS) measure: Clinical Activity Score (CAS) measure: Clinical Activity Score (CAS) measure: Clinical Activity Score (CAS) measure: Severity score measure: Severity score measure: Severity score measure: Severity score measure: Saltin-Grimby Physical Activity Scale (SGPAS) measure: Saltin-Grimby Physical Activity Scale (SGPAS) measure: Saltin-Grimby Physical Activity Scale (SGPAS) measure: Saltin-Grimby Physical Activity Scale (SGPAS) measure: Composite score of changes sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Agneta Lindo status: RECRUITING city: Göteborg zip: 413 45 country: Sweden name: Agneta Lindo role: CONTACT phone: +4676-6185481 email: agneta.lindo@vgregion.se name: Helena Filipsson Nyström role: PRINCIPAL_INVESTIGATOR lat: 57.70716 lon: 11.96679 hasResults: False

 nctId: NCT06309303 id: RC 12/20 briefTitle: Kawasaki Disease During the COVID-19 Epidemic acronym: KAWACOVID overallStatus: COMPLETED date: 2020-07-01 date: 2023-12-31 date: 2023-12-31 date: 2024-03-13 date: 2024-03-13 name: IRCCS Burlo Garofolo class: OTHER briefSummary: Northern Italy is the second region hit by the SARS-COV2 infection worldwide. Data on COVID-19 clinical presentation in children is still scarce, but fewer rate of infection and milder disease seem typical of this age group. In the last three weeks it has been reported an abnormal number of critically ill patients with clinical characteristics consistent with Kawasaki Shock Syndrome (KSS). The common manifestations are: "middle aged" children (6-9 y/o) with a history of persistent high spiking fever in the last days, abdominal pain, diarrhea, skin rash and rapidly deteriorating clinical condition with the onset of shock, without clear signs of dehydration. Other less common features are arthralgia, cough, meningism, conjunctivitis and reddened, cracked lips. Labworks usually show high inflammatory markers, low lymphocyte counts, low sodium, and high troponin levels. Echocardiography have been consistent with myocarditis in the majority of patient instead of classical coronary artery abnormalities. Patients have been diagnosed as Kawasaki disease (typical or incomplete) and treated accordingly with IntraVenous ImmunoGlobulin (IVIG) and/or steroids. One patient refractory to such treatments responded successfully to intravenous Anakinra. All the patients reported a family history consistent with COVID-19, serology and naso-pharyngeal swabs were inconsistently positive. To date we are aware of at least 10 such cases. KSS is a rare and dreadful complication, with an estimated prevalence of 5% of patients with Kawasaki Disease (KD). Given the extreme rarity of this condition, the occurrence of so many cases in the last weeks points to a possible causative agent. As our hospitals are in high endemic area, SARS-COV2 seems the most obvious, although testing for such infection in patients returned conflicting results. It is not clear, at this moment, if this clinical entity is a proper KD triggered by SARS-COV2, or a systemic vasculitis with similar features of KD, secondary to SARS-COV2 infection. The aim of this nationwide study is to better define this clinical entity. conditions: Kawasaki Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 25 type: ACTUAL name: Clinical evaluation measure: Number of subjects with Kawasaki Disease and concomitant SARS-COV-2 infection measure: Number of subjects with Kawasaki Disease without concomitant SARS-COV-2 infection sex: ALL minimumAge: 1 Month maximumAge: 18 Months stdAges: CHILD facility: IRCCS Burlo Garofolo city: Trieste zip: 34137 country: Italy lat: 45.64953 lon: 13.77679 hasResults: False

 nctId: NCT06309290 id: FAPESP-UFRO briefTitle: Prehabilitation With Resistance-exercise Training for Breast Cancer Neoadjuvant Therapy acronym: PRE-RET overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08 date: 2025-01 date: 2024-03-13 date: 2024-03-15 name: Universidad de La Frontera class: OTHER briefSummary: Breast cancer stands as the foremost cause of cancer-related deaths among women worldwide, with the highest incidence of any cancer type. The choice of therapeutic interventions hinges upon factors like cancer stage, cell subtype, and tumor size. Consequently, individuals with more aggressive tumors, such as HER+2 and Triple Negative, or larger tumors often undergo neoadjuvant chemotherapy before breast surgery. However, these anticancer treatments come with side effects like cancer-related fatigue, reduced functional capacity, and changes in body composition, notably skeletal muscle atrophy. Skeletal muscle loss correlates with heightened mortality rates, cardiotoxicity, and diminished quality of life, underscoring the need for early therapeutic interventions. One such promising strategy is prehabilitation, which involves resistance-exercise training aimed at bolstering skeletal muscle mass from the outset of the disease, even preceding breast surgery. Resistance-exercise training has shown favorable effects on women undergoing adjuvant therapy or survivors of breast cancer, however, its molecular and clinical effects in women with breast cancer undergoing neoadjuvant therapy are unknown. conditions: Prehabilitation conditions: Breast Cancer conditions: Postmenopause conditions: Resistance Training studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Prehabilitation with resistance-exercise training name: Usual care program measure: Change in skeletal muscle mass (measured via Computed tomography (CT) scan) measure: Change in arms and legs strength (measured via 1-Repetition Maximum (1RM) testing) measure: Change in hand grip strength (measured via JAMAR handheld dynamometer) measure: Change in physical performance measured via Short physical performance battery measure: Change in points quality of life measured via questionnaire European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) measure: Change in points Brief fatigue inventory (BFI) measure: Change in microgram per milliliter (µg/ml) of Human Insulin via ELISA measure: Change in pathological complete response rate measure: Change quantification proteins sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fundación Arturo López Pérez city: Santiago country: Chile lat: -33.45694 lon: -70.64827 facility: Department of Rehabilitation Sciences, Faculty of Medicine, Universidad de La Frontera. Temuco, Chile city: Temuco country: Chile lat: -38.73965 lon: -72.59842 hasResults: False

 nctId: NCT06309277 id: GLG-100X briefTitle: A Clinical Study to Evaluate of Single and Multiple Oral Doses of GM-1020 in Patients With MDD overallStatus: RECRUITING date: 2024-02-01 date: 2024-07 date: 2024-07 date: 2024-03-13 date: 2024-04-04 name: Gilgamesh Pharmaceuticals class: INDUSTRY briefSummary: The aim of this Phase 2a study in patients with MDD is to assess safety and tolerability and preliminary antidepressant efficacy. conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: GM-1020 measure: Incidence of treatment emergent adverse events measure: Montgomery-Åsberg Depression Rating Scale (MADRS) Change from baseline to 72 hours sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MAC Clinical Research status: RECRUITING city: Manchester country: United Kingdom name: Gregory role: CONTACT lat: 53.48095 lon: -2.23743 hasResults: False

 nctId: NCT06309264 id: C5059-R id: I01RX005059 type: NIH link: https://reporter.nih.gov/quickSearch/I01RX005059 briefTitle: Comparing Hearing Aid Fitting Methods in Blast-exposed Veterans acronym: SBA overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-03-31 date: 2028-03-31 date: 2024-03-13 date: 2024-03-13 name: VA Office of Research and Development class: FED name: University of California, San Diego name: NADI Inc. briefSummary: Since 2000, at least 250,000 U.S. Service members have experienced a blast-related mild traumatic brain injury. A retrospective analysis of over 100,000 post-9/11 Veterans shows that blast injury more than doubles the risk of a diagnosed auditory problem. Many blast-exposed Veterans experience "functional hearing difficulties" (FHDs): problems in challenging listening environments despite clinically normal hearing as measured by the pure-tone audiogram. VA audiologists have begun using low-gain hearing aids to treat FHDs, but there are no concrete guidelines for this application given standard procedures rely on the pure-tone audiogram. This study proposes a data-driven approach called speech-based audiometry (SBA), which optimizes hearing aid gains from a patient's responses to speech stimuli in aided conditions. This trial will assess the behavioral (speech recognition in noise, subjective listening difficulty) and neurophysiological (functional neuroimaging during a speech recognition task) benefits of low-gain hearing aids programmed conventionally or with SBA among blast-exposed Veterans with FHDs. conditions: Auditory Diseases, Central studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: This study is a 2x2 randomized trial. Each subject receives a low-gain hearing aid. The randomized factors are:

1. Fitting method. Half of the subjects have their hearing aids programmed using conventional methods based on the pure-tone audiogram. The remainder have their hearing aids programmed using the gain profile selected from speech-based audiometry.
2. Daily hearing aid use. Half of the subjects will be assigned to use their hearing aids routinely in daily life for a six-week acclimatization period. The remaining half will be followed for the same six-week period but will use their hearing aids only to complete pre-post (mQuickSIN, fMRI) and weekly (DIN) laboratory assessments for speech recognition in noise. The daily use group will complete the same assessments.

The factors are fully crossed such that there are four groups in the experiment. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Factor 1 is single blind: Participants will not know which procedure is used to program their hearing aid, but the investigator/outcomes assessor will. Factor 2 is unblinded: Participants will know whether they are assigned to the daily hearing aid use group. whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Phonak Lumina P90 measure: Change in Modified Quick Speech-in-Noise Test (mQuickSIN) Score at 6 weeks measure: Abbreviated Profile of Hearing Aid Benefit (APHAB) measure: Change in Digits in Noise Test (DIN) Score at Weekly Intervals from Baseline to 6 weeks measure: Change in fMRI Activation at 6 weeks sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: VA Loma Linda Healthcare System, Loma Linda, CA city: Loma Linda state: California zip: 92357-1000 country: United States name: Maria I Rodriguez role: CONTACT phone: 909-583-6050 email: maria.Rodriguez9@va.gov name: Ernest M Alva role: CONTACT phone: (909) 825-7084 phoneExt: 1500 email: ernest.alva@va.gov name: Jonathan Venezia, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.04835 lon: -117.26115 facility: VA Greater Los Angeles Healthcare System, Sepulveda, CA city: Sepulveda state: California zip: 91343 country: United States name: Delia Karahalios, AuD role: CONTACT phone: 818-891-7711 phoneExt: 32752 email: delia.karahalios@va.gov name: Jamie Spector, AuD role: CONTACT phone: 8188917711 phoneExt: 7062 email: jamie.spector@va.gov lat: 34.16167 lon: -118.28285 facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA city: West Los Angeles state: California zip: 90073-1003 country: United States name: Delia Karahalios, AuD role: CONTACT phone: 818-891-7711 phoneExt: 32752 email: delia.karahalios@va.gov name: Guneet Missan, AuD role: CONTACT phone: 3104783711 phoneExt: 40613 email: guneet.missan@va.gov lat: 34.0464 lon: -118.44813 hasResults: False

 nctId: NCT06309251 id: KetoSTrENgTH briefTitle: Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients overallStatus: RECRUITING date: 2022-03-01 date: 2025-05-31 date: 2026-05-31 date: 2024-03-13 date: 2024-03-13 name: Danone Nutricia SpA Società Benefit class: INDUSTRY briefSummary: The goal of this observational study is to learn about the clinical and nutritional effectiveness of ketogenic diet (KD) in pediatric patients with genetic, neurological or metabolic conditions requiring KD.

The main question\[s\] it aims to answer are:

* does KD support adequate growth?
* does KD improve clinical symptoms?
* how does KD impact quality of life? Participants will be followed up as per clinical practice conditions: Drug Resistant Epilepsy conditions: Autism Spectrum Disorder conditions: Chronic Migraine conditions: Brain Tumor, Pediatric studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: ketogenic diet (as per clinical practice) measure: Nutritional adequacy measure: Nutritional adequacy measure: % of responders to KD measure: Health related quality of life improvement through parent questionnaire sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: ASST Fatebenefratelli Sacco (PO "V. Buzzi") status: RECRUITING city: Milan state: MI zip: 20154 country: Italy name: Sara Olivotto, MD role: CONTACT email: sara.olivotto@asst-fbf-sacco.it name: Roberto Previtali, MD role: CONTACT email: roberto.previtali@unimi.it lat: 45.46427 lon: 9.18951 facility: Fondazione "Istituto Neurologico Nazionale C. Mondino" status: RECRUITING city: Pavia state: PV zip: 27100 country: Italy name: Valentina De Giorgis, MD role: CONTACT email: valentina.degiorgis@mondino.it name: Carlo Alberto Quaranta, MD role: CONTACT email: carloalberto.quaranta01@universitadipavia.it lat: 45.19205 lon: 9.15917 facility: Ospedale Pediatrico Bambino Gesù status: RECRUITING city: Roma state: RM zip: 00165 country: Italy name: Antonella Diamanti, MD role: CONTACT email: antonella.diamanti@opbg.net lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06309238 id: LightBAR briefTitle: Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial acronym: LightBAR overallStatus: RECRUITING date: 2024-04 date: 2027-12 date: 2048-12 date: 2024-03-13 date: 2024-04-25 name: Carsten Dirksen class: OTHER name: University of Copenhagen name: University of Southern Denmark name: University of Oxford name: University of Bristol name: Copenhagen Trial Unit, Center for Clinical Intervention Research briefSummary: With this trial, the aim is to assess the benefits and harms of a non-surgical intensive weight loss intervention that includes total dietary replacements, behavioural support and weight-loss medication compared with bariatric surgery for people with severe and complex obesity. The interpretation of the results will help inform future care pathways for people with obesity in whom bariatric surgery is currently the only available effective treatment option. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Due to the nature of the interventions, it will not be possible to blind the participants or the healthcare providers administering the interventions.

Blinded outcome assessment will be employed for the primary outcome and anywhere else possible. When assessing clinical outcomes, the participants will be asked not to disclose their assigned intervention group to the outcome assessor. Further, they will be provided with a plain white t-shirt, or similar, to wear during clinical assessments to cover the presence of surgical scars.

Statisticians and investigators drawing conclusions will be fully blinded. We will conduct the statistical analyses with the intervention groups coded as e.g., 'A' and 'B'. We will write two abstracts while the blinding is intact; one assuming the experimental intervention group is 'A' and the control intervention group is 'B', and one assuming the opposite. After these two abstracts have both obtained consensus, the code will be broken by the data manager. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 500 type: ESTIMATED name: Intensive weight loss intervention name: Bariatric surgery measure: MetS-Z measure: Weight measure: Gait speed measure: Short-Form-36, mental component score measure: SAE measure: Proportion of participants with at least one adverse events (AE) of special interest. Each of the AE will also be assessed individually exploratorily. measure: Cardiometabolic health - metabolic syndrome measure: Cardiometabolic health - blood pressure measure: Cardiometabolic health - pulse measure: Cardiometabolic health - glucose measure: Cardiometabolic health - Hb1Ac measure: Cardiometabolic health - insulin measure: Cardiometabolic health - HOMA2-IR measure: Cardiometabolic health - lipids measure: Cardiometabolic health - eGFR measure: Cardiometabolic health - hsCRP measure: Cardiometabolic health - Fib-4 measure: Cardiometabolic health - proteinuria measure: Cardiometabolic health - TSH measure: Weight and body composition - weight loss measure: Weight and body composition - waist circumference measure: Weight and body composition - body fat and lean body mass measure: Physical functioning - sedentary and active measure: Physical functioning - sit to stand test measure: Medication use measure: Micronutrient status, assessed as proportion of participants with deficiency measure: Bone mineral density (BMD) assessed by DXA measure: Sleep - ESS measure: Sleep - sleep and wake time measure: Sleep - sleep movement measure: Health-related quality of life and mental health - EQ-5D-5L, index score measure: Health-related quality of life and mental health - EQ-5D-5L, VAS measure: Health-related quality of life and mental health - SF-36 measure: Health-related quality of life and mental health - EDE-Q measure: Health-related quality of life and mental health - WBIS-M measure: Health-related quality of life and mental health - MDI measure: Labour market attachment - WPAI measure: Labour market attachment - days of sick leave measure: Continuous glucose monitoring - hypoglycaemic range measure: Continuous glucose monitoring - hypoglycaemic events measure: Continuous glucose monitoring - glucose variability measure: Continuous glucose monitoring - hypoglycaemic symptoms measure: Pending additional funding: Genetic profiles' (using comprehensive genetic mapping) association with the metabolic and/or weight loss response to IWL vs bariatric surgery measure: Health economy: Within-trial cost-effectiveness analysis - quality of life measure: Health economy: Within-trial cost-effectiveness analysis - costs measure: Health economy: Within-trial cost-effectiveness analysis - QALY measure: Health economy: Model-based cost-effectiveness analysis - QALY measure: Health economy: Model-based cost-effectiveness analysis - healthcare costs measure: Health economy: Model-based cost-effectiveness analysis - cost effectiveness ratios measure: Long-term effects - mortality and major cardiovascular disease (CVD) measure: Long-term effects - prescription patterns measure: Long-term effect - incident cancer measure: Long-term effect - surgical procedures measure: Long-term effect - fracture risk measure: Long-term effect - health economic and labour market attachment, employment status measure: Long-term effect - health economic and labour market attachment, salary measure: Long-term effect - health economic and labour market attachment, absence measure: Long-term effect - health economic and labour market attachment, sick leave measure: Long-term effect - health economic and labour market attachment, long-term sick leave sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Steno Diabetes Center Aarhus, Aarhus Universitets Hospital status: NOT_YET_RECRUITING city: Aarhus zip: 8200 country: Denmark name: Jens Bruun role: CONTACT lat: 56.15674 lon: 10.21076 facility: The Department of Medicine and Department of Surgery, University Hospital of South West Jutland status: NOT_YET_RECRUITING city: Esbjerg zip: 6700 country: Denmark name: Claus Borg Juhl role: CONTACT lat: 55.47028 lon: 8.45187 facility: The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre status: RECRUITING city: Hvidovre zip: 2650 country: Denmark name: Kirstine N Bojsen-Møller role: CONTACT lat: 55.65719 lon: 12.47364 facility: The Department of Medicine and the Department of Surgery, Zealand University Hospital Køge status: NOT_YET_RECRUITING city: Køge zip: 4600 country: Denmark name: Merethe Hansen role: CONTACT lat: 55.45802 lon: 12.18214 facility: Department of Surgery, Viborg Regional Hospital status: NOT_YET_RECRUITING city: Viborg zip: 8800 country: Denmark name: Peter Rask role: CONTACT lat: 56.45319 lon: 9.40201 facility: Southmead Hospital, North Bristol NHS Trust status: NOT_YET_RECRUITING city: Bristol zip: BS10 5NB country: United Kingdom name: Dimitri Pournaras role: CONTACT lat: 51.45523 lon: -2.59665 facility: Southampton General Hospital, University Hospital Southampton NHS Foundation Trust status: NOT_YET_RECRUITING city: Southampton zip: SO16 6YD country: United Kingdom name: James Byrne role: CONTACT lat: 50.90395 lon: -1.40428 facility: Musgrove Park Hospital, Somerset Foundation NHS Trust status: NOT_YET_RECRUITING city: Taunton zip: TA1 5DA country: United Kingdom name: Richard Welbourn role: CONTACT lat: 51.01494 lon: -3.10293 hasResults: False

 nctId: NCT06309225 id: BMDA-2301 briefTitle: Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly acronym: (DACHOC-E) overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2026-03-01 date: 2026-06-01 date: 2024-03-13 date: 2024-03-13 name: Omar Mahmoud class: OTHER briefSummary: Previous studies of this type of head and necl cancer have shown high rates of cancer control but result in many short and long term side effects when treated with high dose radiation and chemotherapy. Recently, investigators have noticed similar high rates of cancer control in small numbers of patients who receive less intensive treatments using lower doses of radiation, smaller radiation fields with chemotherapy. It is expected that the side effects of treatment with lower doses of radiation would be less.

For this reason this study is looking at a different regimen of reducing the intensity of the treatment.

The purpose of this study is to compare any good and bad effects of using lower dose smaller fields radiation therapy and chemotherapy with published outcomes. This study will allow the researchers to know whether these different approaches are better, the same, or worse than the usual approach. To be better, the study approach should result in the same survival rate of the usual approach (about 85 out of 100 patients alive and free of cancer at 2 years) but with less long-term side effects. conditions: Oropharynx Cancer conditions: Frailty studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Modified dose and fields intensity modulated radiotherapy measure: Two-year progression free survival measure: Benefit and Tolerance of Treatment measure: Acute Toxicity measure: Late toxicity measure: Failure pattern sex: ALL minimumAge: 65 Years maximumAge: 99 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06309212 id: 2023-20/687 briefTitle: Assessing the Impact of COVID-19 on HMPV Incidence and Severity Among Adults overallStatus: COMPLETED date: 2023-12-15 date: 2023-12-30 date: 2024-01-30 date: 2024-03-13 date: 2024-03-13 name: Acibadem University class: OTHER briefSummary: Human metapneumovirus (HMPV) is primarily recognized as a childhood pathogen, but its impact on adults remains largely underestimated. This study investigates the prevalence, clinical characteristics, and post-COVID-19 trends of HMPV infection among adults in Istanbul, Turkey. conditions: The Prevalance of HMPV After COVID-19 Pandemic conditions: The Importance of Accurate Diagnosis for HPMV studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2197 type: ACTUAL name: Observation measure: Prevalence of HMPV infection in adults pre- and post-COVID-19 pandemic measure: Comparison of HMPV with other respiratory viruses in adults sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Acibadem University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06309199 id: 0855/66 briefTitle: Prevalence of FGIDs and Probiotics Study acronym: PROOF overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-02 date: 2026-02 date: 2024-03-13 date: 2024-03-13 name: Chulalongkorn University class: OTHER briefSummary: This is a study to evaluate the prevalence of FGIDs in infants using the Thai version of Rome IV diagnostic questionnaire for functional gastrointestinal disorders in infants and evaluate the efficacy of Limosilactobacillus reuteri DSM 17938 to prevent FGIDs in infants. conditions: Functional Gastrointestinal Disorders conditions: Infant Conditions studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention group received probiotics Control group received sunflower and MCT oil primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: These 2 groups was assigned using computer generate with block of 4 and ratio 1:1.

The intervention and placebo were prepare in the same container with the same color, odor and blinded to investigators, participants and guardians. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 512 type: ESTIMATED name: Biogaia name: Placebo measure: The prevalence of functional gastrointestinal disorders in the treatment group measure: The prevalence of functional gastrointestinal disorders in the placebo group measure: Nutrition associated with functional gastrointestinal disorders in infants measure: Gut microbial profiles associated with functional gastrointestinal disorder in infants measure: The sleep quality assessed by Brief Infant Sleep Revise Questionnaire of BISQR measure: Stool metabolomic substances (i.e microbial conjugation of secondary bile acid, aminoacid) and the stool metabolites alteration measure: Fluid intake associated with functional gastrointestinal disorders in infants measure: Stress associated with functional gastrointestinal disorders in infants measure: Antibiotics associated with functional gastrointestinal disorders in infants measure: Economic status associated with functional gastrointestinal disorders in infants measure: Education of caregiver associated with functional gastrointestinal disorders in infants sex: ALL minimumAge: 3 Days maximumAge: 1 Year stdAges: CHILD hasResults: False

 nctId: NCT06309186 id: RC 30/2023 briefTitle: Empowerment and Burnout of Midwives at the End of Health Emergency From COVID-19 overallStatus: RECRUITING date: 2023-01-09 date: 2024-12-31 date: 2024-12-31 date: 2024-03-13 date: 2024-03-18 name: IRCCS Burlo Garofolo class: OTHER briefSummary: As the fifth wave of COVID-19 comes to an end and the pandemic's countermeasures expire, there is a need to assess the impact of the pandemic on health care providers, especially midwives, as the professionals deputed to promote and protect women's holistic health, in all phases, physiological and otherwise, of the life cycle. The midwife considers the person as a whole, in which the mind-body-culture components interact profoundly. Prevention and containment measures have impacted on midwifery clinical and nursing practices with the mandatory continuous use of personal protective equipments (PPE) and social distancing to protect the patient and the practitioner, effectively hindering the intimacy of the woman-midwife relationship. The impact assessment focuses on two dimensions: learning, investigated as perceived empowerment, and perceived malaise, investigated as burnout. Empowerment has a positive connotation, which can offset burnout, a syndrome that affects the physical, psychological and emotional health of midwives and can have significant negative implications on midwife turnover, patient safety and outcomes, and the efficiency of healthcare organisations. conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 64 type: ESTIMATED name: Evaluation of midwifes' burnout measure: Evaluation of empowerment of midwives measure: Number of midwives affected by burnout sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" status: RECRUITING city: Trieste zip: 34137 country: Italy name: Martina Debelli role: CONTACT email: martina.debelli@burlo.trieste.it lat: 45.64953 lon: 13.77679 hasResults: False

 nctId: NCT06309173 id: 0000-00000; ko23Hemkens briefTitle: Development of Digital Biomarkers in Multiple Sclerosis: Validation Study 2 acronym: DreaMS_VS2 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-12 date: 2026-12 date: 2024-03-13 date: 2024-03-20 name: University Hospital, Basel, Switzerland class: OTHER briefSummary: Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS). Diagnosis is established by clinical assessment of persons with MS (PwMS), in combination with imaging and body fluid assessments. Treatment decisions in MS are mainly based on periodic monitoring of disease activity and progression through clinical and imaging assessments.

The predictive and prognostic value of currently used assessments to individualize treatment decisions is still very limited. Emerging digital measures have the potential to provide granular health status measurements that would allow monitoring MS disease activity and progression continuously and remotely, in real-world settings, with minimal disruption of patients' life.

Using the investigators' self developed dreaMS software program the investigators previously identified digital biomarkers (DB) that hold promise to provide detailed and accurate assessments of MS-related health status and disease progression to complement traditional clinical, imaging, or body fluid assessments.

This international, observational study aims to evaluate and validate the generalizability of these DB across different languages and cultural settings to provide DB that are helpful for patient care, research, and regulatory decisions. Beyond this, the processes and data structures created for this study are intended to establish a collaborative research platform for subsequent studies, including pragmatic trials, promoting new long-term international academic collaborations. conditions: Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED measure: Correlation of the digital features with the respective measurements of the clinical reference tests measure: The ability of measurements of the changes in the digital biomarkers over the two-year follow-up to predict worsening in the clinical reference test over the same period expressed as binary variables measure: The ability of the digital biomarker to detect worsening in other relevant reference test results creating converging evidence measure: The ability of the digital biomarker to detect worsening in standard assessments used for treatment of PwMS (clinical, imaging, body fluids) measure: The ability of the digital biomarker to detect change of Patient Reported Outcomes measure: The ability of the digital biomarker to detect occurrence of clinical and other meaningful events (relapses, PIRA, serious adverse events, hospitalizations, working capacity) measure: The relationship of the digital biomarkers with imaging and body fluid markers measure: The relationship of the digital biomarkers with Patient Reported Outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06309160 id: R324A230008 briefTitle: COMPASS Across Settings (CAST) for Improving Transition Outcomes for Students With ASD acronym: CAST overallStatus: RECRUITING date: 2023-12-01 date: 2027-07 date: 2027-07 date: 2024-03-13 date: 2024-03-13 name: Ball State University class: OTHER name: University of Toledo name: Indiana University briefSummary: Purpose: The purpose of this project is to develop and test the COMPASS \[Collaborative Model for Competence and Success\] Across Settings (CAST) intervention to enhance the goal setting and attainment skills of autistic youth. Despite federal education law mandating transition services as part of the Individualized Education Program (IEP) for ensuring good outcomes for students with disabilities, current educational practices have been unable to demonstrate that autistic students experience positive postsecondary outcomes. There are existing, evidence-based interventions aimed at supporting positive outcomes for these students. However, these interventions have not systematically provided coaching support to the caregivers, students, and employment specialists. To address these issues, CAST will integrate three evidence-based interventions for supporting student transitions while providing this critical coaching support. By doing so, CAST aims to align the priorities and goals of interventions across home, school, and community settings to better support positive postsecondary outcomes for autistic students. conditions: Autism conditions: Autism Spectrum Disorder conditions: Autistic Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pre-post; randomized control primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Independent observer evaluating goal attainment outcomes whoMasked: OUTCOMES_ASSESSOR count: 297 type: ESTIMATED name: COMPASS Across Settings (CAST) measure: Goal Attainment of IEP progress (Ruble et al., 2012; 2018). measure: Attainment of Postsecondary Goals (Ruble et al., 2019) measure: Fidelity Assessment of Initial CAST consultation (Ruble et al., 2018) measure: Fidelity Assessment of CAST Coaching (Ruble et al., 2018) measure: Organizational Connectedness measure: Transition Plan Quality (Ruble et al., 2019) sex: ALL minimumAge: 16 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ball State University status: RECRUITING city: Muncie state: Indiana zip: 47306 country: United States name: Lisa Ruble, PhD role: CONTACT phone: 765-285-5702 email: laruble@bsu.edu lat: 40.19338 lon: -85.38636 hasResults: False

 nctId: NCT06309147 id: ALX-923-107 briefTitle: A Study to Assess the Safety of BMS-984923 Compared to Placebo, in People With Parkinson's overallStatus: RECRUITING date: 2024-03-15 date: 2025-02-15 date: 2025-07-15 date: 2024-03-13 date: 2024-03-18 name: Allyx Therapeutics class: INDUSTRY name: Michael J. Fox Foundation for Parkinson's Research briefSummary: A Phase 1, randomized, double-blind, placebo-controlled study of BMS-984923 administered orally twice daily (BID) for 28 days in participants with Parkinson's disease. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double blind, parallel, 3-arm, placebo controlled primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Matching placebo whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 18 type: ESTIMATED name: BMS-9894923 measure: Incidence of treatment-emergent adverse events (TEAEs) measure: Area under the curve for the first 24 hours of dosing (AUC24h) and at steady state as determined by pharmacokinetic modeling measure: To evaluate changes in α-synuclein measure: Change from baseline dopamine transporter measure: Assess changes in motor function sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duke Clinical Research Institute status: RECRUITING city: Durham state: North Carolina zip: 27701 country: United States name: Alexis Schuettke role: CONTACT phone: 919-668-2842 email: alexis.schuettke@duke.edu lat: 35.99403 lon: -78.89862 hasResults: False

 nctId: NCT06309134 id: R34AA030662 type: NIH link: https://reporter.nih.gov/quickSearch/R34AA030662 briefTitle: The Healthy Families Bright Futures Program overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2025-07 date: 2026-08 date: 2024-03-13 date: 2024-03-13 name: University of Colorado, Colorado Springs class: OTHER name: University of Nebraska Lincoln briefSummary: The goal of this clinical trial is to learn about an online group program (Healthy Families Bright Futures program) for LGBTQ+ teens and their caregivers. The main question\[s\] it aims to answer are: • is this program acceptable, appropriate, and feasible for LGBTQ+ youth and their caregivers • does the program affect teen (alcohol use, dating violence, alcohol use refusal self-efficacy, healthy communication self-efficacy) and caregiver (accepting behaviors, parenting self-efficacy, parenting behaviors) outcomes associated with risk for dating violence and alcohol use among LGBTQ+ teens. Participants will participate in a one-hour weekly online group for seven weeks with separate groups for teens and caregivers. conditions: Alcohol Drinking conditions: Violence in Adolescence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned by algorithm to either complete the program or to waitlist. Allocation to conditions will be 50/50. Randomization will occur at the dyad level. primaryPurpose: PREVENTION masking: NONE count: 160 type: ESTIMATED name: Healthy Families Bright Futures Program measure: Measure of Adolescent Relationships and Harassment and Abuse - Victimization measure: Measure of Adolescent Relationships and Harassment and Abuse - Perpetration measure: Monitoring the future alcohol use intentions measure: Monitoring the future alcohol use items measure: Drinking Refusal Self-Efficacy Questionnaire- Shortened adolescent version measure: Conflict Tactics Scale- 2 (SGM Specific IPV Perpetration) measure: Conflict Tactics Scale- 2 (SGM Specific IPV Victimization) measure: Program acceptability, appropriateness, and feasibility ratings (drawn from Weiner) measure: PHQ-8 (modified for adolescents) measure: LGBTQ+ teen perceived drinking norms measure: LGBTQ+ teen perceived dating violence norms measure: Sexual communication self-efficacy scale measure: Communication skills test (modified to assess self-efficacy) measure: Short Internalized Homonegativity Scale. measure: Self-Efficacy for Parenting Adolescents Scale measure: Parental Monitoring Short Scale measure: Parent Adolescent Communication Scale measure: Alabama Parenting Questionnaire- Short form measure: Social and Emotional Competencies Questionnaire measure: LGBTQ+ Microaggressions and Microaffirmations in Families sex: ALL minimumAge: 15 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: University of Colorado Colorado Springs city: Colorado Springs state: Colorado zip: 80918-3733 country: United States name: Heather Littleton, PhD role: CONTACT phone: 719-255-3108 email: hlittlet@uccs.edu name: Heather Littleton, PhD role: PRINCIPAL_INVESTIGATOR lat: 38.83388 lon: -104.82136 hasResults: False

 nctId: NCT06309121 id: PIC-11-24 briefTitle: Effects of the Postbiotic Blend ABB C3 on Adiposity and Glucose Metabolism in Children and Adolescents acronym: PostOb overallStatus: RECRUITING date: 2024-04-10 date: 2025-01-31 date: 2025-04-30 date: 2024-03-13 date: 2024-04-22 name: Fundació Sant Joan de Déu class: OTHER briefSummary: This study investigates the effects of a postbiotic combination called ABB C3 on reducing body fat and improving metabolic health in children and teenagers. The study consists of a 3-month trial with half participants taking ABB C3 and the other half a placebo, monitoring body composition and blood markers. Afterward, participants can continue with ABB C3 for an additional 3 months. The goal is to determine if ABB C3 is a safe and effective way to help young people improve their health by reducing body fat. conditions: Obesity, Childhood conditions: Obesity, Adolescent studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized double-blind placebo-controlled study with a treatment group and an active control parallel group. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Postbiotic ABB C3 name: Placebo name: Follow-up Postbiotic ABB C3 (Optional) measure: Incidence of Adverse Events measure: Change in adiposity (% fat body mass) measure: Change in blood glycated hemoglobin (HbA1c) levels measure: Change in adiposity (% fat body mass) measure: Change in blood glycated hemoglobin (HbA1c) levels measure: Change in BMI z-score measure: Change in body composition measure: Change in insulin sensitivity measure: Change in lipid profile (triglycerides, cholesterol) measure: Change in blood pressure measure: Change in Beck Depression Inventory-II (BDI-2) measure: Change in Beck Anxiety Inventory-II (BAI-2) measure: Change in gut microbial abundance and diversity measure: Change in plasma metabolite concentrations sex: ALL minimumAge: 8 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Hospital Sant Joan de Déu status: RECRUITING city: Barcelona zip: 08950 country: Spain name: Marta Ramon Krauel, MD PhD role: CONTACT phone: (+34) 932804000 phoneExt: 71263 email: marta.ramon@sjd.es name: Carles Lerin, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06309108 id: 2022/68-04 id: İUC type: OTHER domain: İUC briefTitle: Bariatric Surgery and Patient Education overallStatus: COMPLETED date: 2022-01-02 date: 2022-05-02 date: 2023-07-18 date: 2024-03-13 date: 2024-03-13 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: Obesity is a disease that poses a health risk and is increasing worldwide. Bariatric surgery is the most effective method used in the treatment of obesity. Preoperative health education for bariatric surgery patients is important to support surgery. There is not enough nursing research in the literature regarding training patients with two different materials before bariatric surgery. The purpose of the randomized controlled experimental study designed in light of this information was to determine the effect of education given to patients with two different materials before bariatric surgery on early complications. The rates of the study were determined by randomizing trial I, trial II, and control treatment in 66 rooms that met the interval and study screening criteria offered between May 2022 and June 2023 in the general surgery service of a university hospital. Data from the research; was collected with the Veria Total Form, Autar Risk Assessment Scale, Apfel Risk Score, Visual Comparison Scale-VAS (Visual Analog Scale-VAS), Training Satisfaction Survey, and Complication Monitoring Form. In the first face-to-face meeting in the experimental groups, we were given training by the researcher with the removable Training Booklet I and Training Booklet II and were monitored until discharge. No control group training was given. conditions: Bariatric Surgery Candidate conditions: Education conditions: Patient Education studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In our study, patients who would undergo bariatric surgery were selected randomly. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 66 type: ACTUAL name: Education Booklet name: Augmented Reality Group measure: Veria Total Form for sociodemographic features measure: Autar Risk Assessment Scale for DVT measure: Apfel Risk Score for nausea and vomiting measure: Visual Analog Scale-VAS for pain measure: Training Satisfaction Survey measure: Complication Monitoring Form to determine whether complications develop sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: İstanbul University- Cerrahpasa Instutite Graduate Studies city: İstanbul state: Avcılar zip: 34320 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06309095 id: AFSU_AhmetDemirhanUygun_001 briefTitle: Investigation of the Effect of Low Torque and Speed on Post-Operative Pain After Root Canal Treatment overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-03-15 date: 2024-04-15 date: 2024-03-13 date: 2024-03-13 name: Afyonkarahisar Health Sciences University class: OTHER briefSummary: Root canal preparation is one of the most important stages in root canal treatment. Nowadays, the use of Nickel-Titanium(Ni-Ti) rotary instrument systems for root canal expansion is becoming very popular. The force required to rotate the Ni-Ti file is defined as the torque force and is considered a parameter for the stress produced within the canal. Ni-Ti rotary instruments can be used with a wide speed scale between 150 rpm (rotary per minute) and 40,000 rpm in conventional endodontic engines.

Low torque and speed values mean low pressure applied by the instruments in the root canal. With low forces and vibrations, motor noise is generally negligible, and the instruments can easily shape most root canals in a reasonable amount of time and with minimal mechanical stress (in medium-easy canals). The use of lower torque values has been shown to reduce cyclic fatigue of Ni-Ti rotary tools. With reduced cyclic fatigue, the risk of instrument breakage in complex root canal morphologies is minimized and complications that may occur during root canal treatment are reduced. However, with low torque and speed values, cutting efficiency decreases and the process time increases as the instrument advances in the canal and during possible treatment. Decreasing cutting efficiency may also result in the operator applying force to move through the canal. With the applied force, the friction resistance within the canal increases and the heat produced increases. For this reason, it is thought that the risk of post-operative pain may increase during or after the procedure.

The aim of this study is to investigate the incidence of post-operative pain and procedure time using the visual analog scale (VAS) among groups where low torque and speed values were applied during the use of the Ni-Ti rotary instrument system. conditions: Dental Pulp Necrosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: use of VDW Silver Endodontic motor measure: Visual analog scale measure: Preparation time sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Afyonkarahisar Health Science University city: Afyonkarahisar zip: 03030 country: Turkey name: Ahmet D Uygun, Assoc. Prof. role: CONTACT phone: +905057513705 email: ademirhan100@hotmail.com name: Betül Karaağaç, R.A. role: CONTACT phone: +905347934602 email: karaagacbetull@gmail.com lat: 38.75667 lon: 30.54333 hasResults: False

 nctId: NCT06309082 id: DFU briefTitle: Assessing Diabetic Foot Ulcer Microcirculation With High-frequency Contrast Enhanced Ultrasound overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-12 date: 2026-12 date: 2024-03-13 date: 2024-03-13 name: First Affiliated Hospital of Wenzhou Medical University class: OTHER briefSummary: The objective of this observational study is to investigate and validate the utility of high-frame-rate ultrasound imaging technology for dynamic observation of the blood perfusion process at the site of ulcer wounds in real-time, focusing on patients with Diabetic Foot Ulcers (DFU). The primary research questions it seeks to address are as follows:

* What are the dynamic characteristics of vascular dynamics at the site of ulcer wounds in patients with DFU under high-frame-rate ultrasound imaging?
* Is High-Frequency Contrast-Enhanced Ultrasound (H-CEUS) technology feasible for effectively visualizing the microcirculation of ulcer wounds in patients with DFU? Participants will Undergo high-frame-rate ultrasound imaging for real-time observation of blood perfusion dynamics at the site of ulcer wounds.

Researchers will compare ulcerated sites with normal sites to see whether the use of High-Frequency Contrast-Enhanced Ultrasound (H-CEUS) has any discernible impact on the visualization of microcirculation in ulcer wounds. conditions: Diabetes Mellitus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: H-CEUS score sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: the First Affiliated Hospital the First Affiliated Hospital city: Wenzhou state: Zhejiang zip: 325006 country: China name: Shihao Xu role: CONTACT phone: 13857766918 email: dcxshvip@wmu.edu.cn name: Shihao Xu role: PRINCIPAL_INVESTIGATOR lat: 27.99942 lon: 120.66682 hasResults: False

 nctId: NCT06309069 id: LOCAL/2024/TP-01 id: IRB 24.01.01 type: OTHER domain: CHU de Nîmes briefTitle: Calcified Cerebral Embolism: a Descriptive Study in a Large Single Center Cohort acronym: CCE Cohorte overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-04 date: 2024-04 date: 2024-03-13 date: 2024-03-13 name: Centre Hospitalier Universitaire de Nīmes class: OTHER briefSummary: Calcified cerebral embolism (CCE) is a relatively rare but underdiagnosed cause of infarction. CCE diagnosis is made by CT. Radiological characteristics of CCE have been reported in small case series. The aim of this study was to describe clinical and radiological characteristics of CCE in a large number of patients, and to compare patients with different radiological CCE characteristics. conditions: Calcified Cerebral Embolism studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 79 type: ESTIMATED name: None, purely observational study measure: Calcified aortic brachiocephalic measure: cardiovascular risk measure: history of stroke measure: Population measure: Population measure: history of surgical/endovascular cardiovascular intervention measure: NIHSS measure: calcified aortic arch measure: calcified carotid measure: atherosclerotic plaques measure: calcified aortic valves measure: calcified mitral valves measure: CCE diameter measure: density measure: involved cerebral artery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Nîmes city: Nîmes zip: 30029 country: France name: Teodora PARVU role: CONTACT phone: +33466685008 email: teodora.parvu@chu-nimes.fr lat: 43.83333 lon: 4.35 hasResults: False

 nctId: NCT06309056 id: MP-05-2024-3903 briefTitle: Neuromuscular Electrical Stimulation for Children With Dysphagia overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-03 date: 2024-03-13 date: 2024-03-13 name: Sir Mortimer B. Davis - Jewish General Hospital class: OTHER briefSummary: This study aims to measure if using neuromuscular electrical stimulation (NMES) effectively improves swallowing, drooling (if applicable), feeding ability, physical growth and quality of life in children with severe dysphagia. This pilot study is for children aged over 18 months old with dysphagia. It aims to investigate a new approach to help children improve their swallowing function. Some published studies have shown that electrical stimulation to muscles involved in swallowing may help children with dysphagia.

In this pilot study, NMES will be used. This procedure delivers electrical stimulation to make participants' muscles contract. Electrodes are placed on the skin, over the muscles that help with swallowing, and an electric current is delivered through wires which are connected to a small machine. The current is controlled through a small, handheld device. NMES will be applied to muscles involved in eating, drinking and swallowing. NMES will be applied to the participant alongside their regular treatment. No medications or treatments will be added, modified or discontinued as part of this study.

The overall duration of the study per participant will last a total of nine months. For the first three months, the participant will receive the NMES twice a week. There will be no interventions or follow-up appointments scheduled for the following 6 months. Then, there will be a final follow-up meeting 9 months following the start of the intervention to evaluate for lasting changes. conditions: Dysphagia studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients being followed at the Lethbridge-Layton-Mackay Rehabilitation Centre Salivation Management Clinic and the Dysphagia and Feeding Disturbance Clinic who meet inclusion criteria will be recruited. If caregivers/participants consent to the study, they will be enrolled in the intervention arm. Any potentially eligible participant who declines to participate in the study will be recruited as a control group. These participants will complete the questionnaires at the same timepoints as the interventional group and data from the medical charts will be included in the study. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: VitalStim measure: Feeding Intake - Functional Oral Intake Scale measure: Penetration and Aspiration Scale measure: Quality of Life - Pediatric Quality of Life Inventory 4.0 Generic Core Scale for Toddlers, Young Children, Children 8-12 years old OR Teenagers. measure: Body Mass Index (kg/m^2) sex: ALL minimumAge: 18 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06309043 id: HLX05-001 briefTitle: A Randomized, Single Intravenous Dose, Parallel Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX05 Vs. Erbitux® (Cetuximab) in Healthy Adult Male Chinese Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04-12 date: 2025-06-01 date: 2025-12-31 date: 2024-03-13 date: 2024-03-13 name: Shanghai Henlius Biotech class: INDUSTRY briefSummary: This is a randomized, single intravenous dose, parallel study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX05 vs. Erbitux® (US-, EU-, and CN-sourced) in healthy adult male Chinese subjects. This study is divided into two parts. conditions: EGFR Overexpression studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 268 type: ESTIMATED name: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection measure: AUC0-inf measure: Cmax measure: Tmax measure: CL measure: λz sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06309030 id: ZRJY2023-QM21 briefTitle: Clinical Study on the Deep Remission of Rheumatoid Arthritis With Kidney Deficiency and Excessive Cold Syndrome by Bushen Quhan Zhiwang Decoction overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2026-08-01 date: 2024-03-13 date: 2024-03-13 name: Liu Longxiao class: OTHER briefSummary: The investigators conduct this randomized controlled clinical trial to evaluate the efficacy and safety of the Bushen Quhan Zhiwang decoction in patients with RA with kidney deficiency and excessive cold syndrome who have not achieved deep remission and remained at a low level of disease activity despite the use of conventional synthetic disease-modifying antirheumatic drugs. conditions: Rheumatoid Arthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 72 type: ESTIMATED name: Bushen quhan zhiwang decoction name: Bushen quhan zhiwang decoction placebo measure: disease activity score derivative for 28 joints (DAS28) measure: patient reported outcomes（PRO） measure: visual analogue scale for pain measure: withdrawl mechanical threshold measure: erythrocyte sedimentation Rate（ESR） measure: C-reactive protein（CRP） measure: TCM symptom score sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06309017 id: 23-01243 briefTitle: Pre-operative Nutrition for Elective Resection Surgery in Inflammatory Bowel Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2024-12 date: 2025-04 date: 2024-03-13 date: 2024-03-13 name: NYU Langone Health class: OTHER briefSummary: This study aims to determine if improved risk stratification tools and interventions to mitigate malnutrition reduce postoperative risk in patients undergoing elective or emergent resection surgery for inflammatory bowel disease (IBD), and if adding immune modulation nutrition improves surgical outcomes. The primary objective is to assess whether preoperative malnutrition screening and intervention minimize postoperative complications. The secondary objective is to evaluate whether immune modulation nutrition in the peri-operative period decreases length of stay and major complications. conditions: Inflammatory Bowel Diseases studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Nutrition specialist name: Ensure Surgery Immunonutrition shakes measure: Length of hospital stay measure: Proportion of patients who experienced postoperative major complications measure: Proportion of patients who participated in a nutritional intervention program before surgery measure: Proportion of patients who participated in a nutritional intervention program after surgery measure: Number of nutritional shakes completed measure: Percentage of nutritional shakes completed overall measure: Percentage of nutritional shakes completed pre-surgery measure: Percentage of nutritional shakes completed post-surgery measure: Proportion of patients who experienced any postoperative complications measure: Proportion of patients with 30 day readmission sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06309004 id: 2023-00741a briefTitle: Development of an Online ACT Intervention for Disorders of Gut-Brain Interaction acronym: iACTforDGBI overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-01 date: 2024-08-31 date: 2024-03-13 date: 2024-03-13 name: Örebro University, Sweden class: OTHER briefSummary: The goal of this clinical trial is to develop and test the iACTforDGBI intervention in a sample of Swedish individuals with DGBI (Disorders of Gut-Brain Interaction).

The first substudy of this project (Substudy 1) aims to answer the following question: How can the design of iACTforDGBI be tailored to meet the specific needs of individuals with DGBI and clinically meaningful symptoms of anxiety and depression?

Participants (individuals with symptoms compatible with a DGBI and anxiety and/or depression, and healthcare professionals working in DGBI) will be asked to: a) Evaluate a preliminary version of the iACTforDGBI intervention, consisting of self-guided online sessions. b) Participate in online focus-group interviews and provide information on their views of a preliminary version of the iACTforDGBi intervention conditions: Clinically Meaningful Symptoms Levels of Symptoms of DGBI and Depression and/or Anxiety studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Focus group interviews sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06308991 id: IDU-SBF-SD-01 briefTitle: Effect of Touch Methods in Preterm Infants During Endotracheal Aspiration overallStatus: COMPLETED date: 2022-07-01 date: 2023-06-01 date: 2023-06-01 date: 2024-03-13 date: 2024-03-13 name: Izmir Democracy University class: OTHER briefSummary: The purpose of this study was to determine the effect of gentle human touch (GHT) and Yakson methods during endotracheal suctioning on pain, comfort and physiologic parameters response in preterm infants. conditions: Endotracheal Aspiration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The order of the 2 different touching methods and routine care practices to be applied to the infants in the research group was determined by randomized method and 3 groups were created. Considering the order of application in each group, it was decided which touch method and routine care would be applied to the infants. Both touch techniques and routine care practices were applied once to each infant.

Group 1: Yakson touch, Routine care, Gentle HumanTouch Group 2: Routine care, Gentle HumanTouch, Yakson touch Group 3: Gentle HumanTouch, Yakson touch, Routine care primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Yakson touch name: Gentle Human Touch name: Routine care measure: Neonatal Pain Agitation and Sedation Scale (N-PASS) measure: Change in Oxygen saturation measure: Change in Heart rate measure: COMFORTneo Scale sex: ALL minimumAge: 26 Weeks maximumAge: 36 Weeks stdAges: CHILD facility: Izmir Democracy University city: Karabağlar state: Izmir zip: 35140 country: Turkey lat: 38.37396 lon: 27.1352 hasResults: False

 nctId: NCT06308978 id: FT819-102 briefTitle: FT819 in Moderate to Severe Active Systemic Lupus Erythematosus overallStatus: RECRUITING date: 2024-02-24 date: 2027-09-30 date: 2042-09-30 date: 2024-03-13 date: 2024-03-13 name: Fate Therapeutics class: INDUSTRY briefSummary: This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following conditioning chemotherapy in participants with moderate to severe active systemic lupus erythematosus (SLE). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819. conditions: Systemic Lupus Erythematosus studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: FT819 name: Fludarabine name: Cyclophosphamide name: Bendamustine measure: Number of participants with treatment-emergent adverse events (TEAEs) measure: Number of participants with serious TEAEs measure: Number of participants with adverse events of special interest (AESI) measure: Number of participants with TEAEs by severity measure: Number of participants with dose-limiting toxicities (DLTs) measure: Recommend Phase 2 dose (RP2D) of FT819 measure: Percentage of participants achieving definition of remission in SLE (DORIS) complete remission over time measure: Percentage of participants achieving DORIS clinical remission over time measure: Percentage of participants achieving lupus low disease activity state (LLDS) over time measure: Change in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) over time measure: Change in Physician Global Assessment (PGA) over time measure: Change in Functional Assessment of Chronic Illness Therapy (FACIT) over time measure: Change in estimated glomerular filtration rate (eGFR) over time measure: Change in urine creatinine over time measure: Change in urine protein over time measure: Change in protein to creatinine ratio over time measure: Concomitant lupus therapies prior to and following study intervention measure: Plasma concentration of FT819 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Minnesota Medical School status: RECRUITING city: Minneapolis state: Minnesota zip: 55455 country: United States lat: 44.97997 lon: -93.26384 facility: University of Nebraska Medical Center status: RECRUITING city: Omaha state: Nebraska zip: 68198 country: United States lat: 41.25626 lon: -95.94043 hasResults: False

 nctId: NCT06308965 id: Z-2023088 briefTitle: Does Vessel-sparing Surgery in Anterior Approach Total Hip Arthroplasty Change Clinical Outcome? acronym: USP overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2027-03 date: 2024-03-13 date: 2024-03-13 name: Ziekenhuis Oost-Limburg class: OTHER briefSummary: During direct anterior approach (DAA) for total hip arthroplasty (THA), ligation of the lateral femoral circumflex artery and vessel is always conducted. However, this standardized procedure may jeopardize blood muscle perfusion and cause tenderness in the tensor fascia lata muscle. The investigators want to investigate whether blood vessel-sparing surgery is feasible, reproducible, and would alter outcomes following DAA THA.

The surgical technique of the vessel-sparing procedure will be described and investigated in a prospective blinded RCT. The investigators hypothesize that the vessel-sparing technique is feasible in 60% of the patients. If these vessels were not sacrificed, the investigators expect the incidence of TFL tendinopathy to be lower. conditions: Tensor Fasciae Latae Syndrome conditions: Arthroplasty Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: This is a monocentric prospective randomized blinded clinical trial during a period of minimal 3 years or until 150% of sample size is included (100 patients). primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participants will be blinded and randomized into two cohorts. The selection and randomization protocol is as follows: participants eligible for the study are requested to participate and informed by the study nurse. If the patient agreed to participate, informed consent is obtained, and the patient is included in the study. At that time, the study nurse uses a mobile randomization application (Random, Dublin, Ireland) to allocate them either to the 'standard' (sacrificing the vessels) or 'vessel sparing' DAA.

Weighted randomization (1:2) is applied to compensate for a dropout of patients planned for vessel sparing surgery, but in whom the vessels were damaged unintendedly. In case a bilateral procedure will be performed, each side is randomized individually.

Surgery will be performed by the surgeon. Data collection before and after surgery is collected by personal assistant who is unaware of group assignment. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: Vessel technique measure: a) Incidence of TFL tendinopathy measure: b-1) Patient-reported outcome 1: modified Harris Hip Score (HHS) measure: b-2) Patient-reported outcome 2: Hip And Groin Outcome Score (HAGOS) measure: b-3) Patient-reported outcome 3: Forgotten Joint Score measure: b-4) Patient-reported outcome 4: Hip disability and Osteoarthritis Outcome Score (HOOS). measure: c) Component placement (x-rays) measure: Vessel sparing succesfull sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ziekenhuis Oost-Limburg city: Genk state: Limburg zip: 3600 country: Belgium name: Frans-Jozef Vandeputte, M.D. role: CONTACT lat: 50.965 lon: 5.50082 hasResults: False

 nctId: NCT06308952 id: 2024SL0006 briefTitle: Effectiveness of Atorvastatin in Preventing Cerebrovascular Events After Flow Diverter Implantation overallStatus: NOT_YET_RECRUITING date: 2024-03-05 date: 2027-03-31 date: 2027-07-31 date: 2024-03-13 date: 2024-03-13 name: Zhujiang Hospital class: OTHER briefSummary: In recent years, with the development of medical technology and materials and instruments, flow diverter (FD) has gradually become the most important treatment method for the treatment of intracranial aneurysms (IA). It is a revolutionary treatment method, which has changed the concept of endovascular treatment of IA, and turned the previous endovascular embolization to the reconstruction of the parent artery.

At present, FD has been used in more than 250,000 cases worldwide, and the overall 1-year complete occlusion rate of aneurysms can reach 75%-85.5%. However, although the current imaging prognosis of FD is encouraging, the perioperative complications of FD are as high as 12.9%, including ischemic complications, SAH, and parenchymal hemorrhage in 7.3%, 2.0%, and 2.0%, respectively. The postoperative mortality was 1.5%, of which 1.3% were caused by delayed aneurysm rupture, distal parenchymal hemorrhage and PED-related nerve compression symptoms. In addition, an in-stent stenosis of more than 50% within one year has been reported in 10.2 to 15.0% of patients. However, in addition to conventional dual antibody therapy, there is no relevant guideline recommendation or clinical evidence on how to prevent complications after FD implantation in IA patients.

Atorvastatin is widely used in the primary and secondary prevention of cardiovascular and cerebrovascular diseases. Its main effect is to improve the incidence of cardiovascular and cerebrovascular events by reducing blood lipids. Although the mechanism of clinical benefit of lipid-lowering by atorvastatin is not completely clear, a large number of clinical evidence has shown that atorvastatin can also reverse atherosclerosis, stabilize plate, reduce inflammation, reverse vascular endothelial dysfunction and reduce microthrombosis. It can reduce the incidence of cardiovascular and cerebrovascular events in patients with coronary heart disease and internal carotid artery stenosis after stent implantation in different degrees.

However, there is no high-quality clinical evidence for the use of atorvastatin in intracranial aneurysm stent implantation. Previous retrospective studies have shown that atorvastatin is the only protective factor for in-stent restenosis after flow diverter implantation in intracranial aneurysms. In a retrospective observational study involving 273 patients empirically treated with atorvastatin for unruptured IA in our center, the median follow-up period was 7.6 months. The incidence of cerebrovascular events was 3.27%, and the incidence of more than 50% in-stent stenosis was 8.4%, which was significantly lower than the incidence of related events reported at home and abroad.

Therefore, this study planned to conduct a randomized controlled clinical trial to confirm the efficacy and safety of oral atorvastatin in the prevention of cerebrovascular adverse events after stent implantation in patients with unruptured intracranial aneurysms, and to provide objective evidence for the treatment decision of patients with unruptured intracranial aneurysms to prevent cerebrovascular adverse events after flow diverter implantation. conditions: Efficacy Endpoint: no New Cerebrovascular Adverse Events Within 1 Year conditions: Safety Endpoint: no New Moderate or Serious Adverse Events Within 1 Year conditions: All-cause Mortality Events (Within 1 Year) conditions: Incident Ischemic Stroke Events (Within 1 Year) conditions: New Hemorrhagic Stroke Events (Within 1 Year) conditions: New Stent Thrombosis Events (Within 1 Year) conditions: New Symptomatic Stenosis Events (Within 1 Year) conditions: Occurrence of In-stent Stenosis 12th ±1 Month Annual Angiographic Follow-up conditions: Degree of In-stent Stenosis (as Measured by WASID Method) at the 12th ±1 Month Annual Angiographic Follow-up conditions: Target Aneurysm Embolization Rate at 12±1 Month Annual Angiographic Follow-up (Raymond and OKM Classification) studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The subject numbers and corresponding medication numbers are permanently identified and unique for each successfully randomized patient. If any patients who have been successfully randomized do not receive the trial medication or cannot be reassigned to others, their medication and medication numbers will be invalidated by the medication administrator. To ensure blinding during the trial execution, unblinded personnel responsible for administering and configuring the trial drug must sign a confidentiality agreement. Investigators, other blinded investigators, subjects, and sponsors will not have access to any information regarding group assignment or related documents pertaining to the trial drug. primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: The subject numbers and corresponding medication numbers are permanently identified and unique for each successfully randomized patient. If any patients who have been successfully randomized do not receive the trial medication or cannot be reassigned to others, their medication and medication numbers will be invalidated by the medication administrator. To ensure blinding during the trial execution, unblinded personnel responsible for administering and configuring the trial drug must sign a confidentiality agreement. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 386 type: ESTIMATED name: Atorvastatin 20mg measure: Efficacy endpoint: no new cerebrovascular adverse events within 1 year measure: Safety endpoint: no new moderate or serious adverse events within 1 year sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06308939 id: IRB-2024-198 briefTitle: Eribulin Combined With Sintilimab as First-line Treatment for Unresectable Locally Advanced or Metastatic HER2-negative Breast Cancer:A Multicenter, Single-arm,Phase II Clinical Trial overallStatus: NOT_YET_RECRUITING date: 2024-03-08 date: 2025-12-31 date: 2026-08-31 date: 2024-03-13 date: 2024-03-13 name: Zhejiang Cancer Hospital class: OTHER briefSummary: This is a multicenter, single-arm,Phase II clinical trial to explore the efficacy and safety of Eribulin combined with Sintilimab in the first-line treatment of unresectable locally advanced or metastatic HER2-negative breast cancer. conditions: Metastatic Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 81 type: ESTIMATED name: Eribulin name: Sintilimab measure: Objective Response Rate (ORR) measure: Progression-Free Survival (PFS) measure: Clinical Benefit Rate (CBR) measure: Duration of Overall Response(DoR) measure: Time to response (TTR) measure: Overall survival (OS) measure: adverse event(AE) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: zhejiangCH city: Hangzhou state: Zhejiang zip: 310000 country: China name: Ying Xi Shao, doctor role: CONTACT phone: 15824113524 email: 15824113524@163.com name: Jia Xiao Wang, doctor role: CONTACT name: Jia Xiao Wang, doctor role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06308926 id: MRG23ARDS briefTitle: MRG-001 as an Immunoregulatory and Regenerative Therapy for ARDS Patients acronym: SUMMIT overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-02-01 date: 2026-07-01 date: 2024-03-13 date: 2024-03-13 name: MedRegen LLC class: INDUSTRY name: Vanderbilt University Medical Center briefSummary: This is a phase IIa, dose-ranging, proof-of-concept study of MRG-001 in patients with ARDS.

The aim is to determine the safety and preliminary efficacy of MRG-001 across two dose ranges. conditions: Acute Respiratory Distress Syndrome conditions: Respiratory Failure conditions: Respiratory Distress Syndrome conditions: Respiratory Tract Diseases conditions: Cytokine Storm studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: MRG-001 (Low-dose) name: MRG-001 (High-dose) name: Placebo measure: Hemopoietic stem cell mobilization measure: Organ Failure measure: Pharmacokinetics measure: Pharmacokinetics measure: Pharmacodynamics measure: Cytokine Changes measure: Respiratory-Free Days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06308913 id: 2023-1722 id: UW23121 type: OTHER domain: UWCCC id: A534260 type: OTHER domain: UW Madison id: Protocol Version 2/15/2024 type: OTHER domain: UW Madison id: P50DE026787 type: NIH link: https://reporter.nih.gov/quickSearch/P50DE026787 id: P50CA278595-07 type: NIH link: https://reporter.nih.gov/quickSearch/P50CA278595-07 briefTitle: Pembrolizumab, INCB081776, and Radiation Therapy for Head and Neck Squamous Cell Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-08 date: 2026-08 date: 2024-03-13 date: 2024-04-24 name: University of Wisconsin, Madison class: OTHER name: National Institute of Dental and Craniofacial Research (NIDCR) name: National Cancer Institute (NCI) briefSummary: This study is evaluating INCB081776 when given in combination with the checkpoint inhibitor pembrolizumab and palliative radiation therapy in patients with metastatic or recurrent metastatic or recurrent head and neck squamous cell carcinoma (HNSCC). 12 participants will be enrolled and can expect to be on study for up to 12 months. conditions: Head and Neck Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: INCB081776 name: Pembrolizumab name: Palliative RT measure: Incidence of Adverse Events (AEs) measure: Duration of Adverse Events measure: Severity of Adverse Events measure: Overall response rate (ORR) measure: Disease control rate (DCR) measure: Duration of response (DoR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UW Carbone Cancer Center city: Madison state: Wisconsin zip: 53792 country: United States lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06308900 id: CL_SIMULATION_01 briefTitle: Non-technical Skills of Clinical Simulation in Physiotherapy Students overallStatus: RECRUITING date: 2024-02-26 date: 2024-03-31 date: 2024-04-30 date: 2024-03-13 date: 2024-03-15 name: University of Valencia class: OTHER briefSummary: Clinical simulation has gained great importance in recent times in health sciences. Since it is a pedagogical strategy that is being used more and more in health degrees and is very useful for the acquisition of both technical and non-technical skills.

However, if we focus on physiotherapy, the use of clinical simulation is a very new field and therefore requires great research. The investigators still do not have the consistency or experience as in other health branches such as medicine or nursing, in which they have been using simulators for years for the learning of all their students.

For all this, and for the situation of need generated in recent years, in which internships in hospitals and clinical centers were completely abolished, the need for our research is justified, which will allow the acquisition of non-technical skills among novice students. in physiotherapy, without the need for contact with real patients. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 100 type: ESTIMATED name: Clinical simulation measure: Ottawa Scale sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: David Hernández-Guillén status: RECRUITING city: Valencia zip: 46010 country: Spain name: David Hernández-Guillén, PT, PhD role: CONTACT phone: +34644217578 phoneExt: 51232 email: david.hernandez@uv.es lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06308887 id: 01 briefTitle: Comparison of Ultrasound-Guided Perimeniscal Steroid and 5% Dextrose Injections in Knee Osteoarthritis overallStatus: COMPLETED date: 2023-10-02 date: 2024-02-02 date: 2024-03-02 date: 2024-03-13 date: 2024-03-13 name: Kastamonu University class: OTHER briefSummary: Introduction: The primary goal of treating knee osteoarthritis is to reduce pain and improve the patient's quality of life. Medial meniscal extrusion is a condition that is linked to pain and disability in knee osteoarthritis and can be identified through ultrasound. For patients with medial meniscal extrusion, perimeniscal corticosteroid injection has been shown to be a helpful addition to primary treatment for moderate to severe pain relief. Dextrose prolotherapy has also been found to provide periarticular benefits for knee osteoarthritis. This study aims to compare the effectiveness of ultrasound-guided perimeniscal corticosteroid and perimeniscal dextrose injections in patients with osteoarthritis, medial knee pain, and medial meniscal extrusion.

Method: Patients with medial knee pain and meniscal extrusion were randomly divided into two groups using the double-block randomization method. Group 1 included 15 patients who were administered an ultrasound-guided perimeniscal steroid injection, while Group 2 included 16 patients who were administered an ultrasound-guided perimeniscal dextrose injection. The patients' pain levels were evaluated using the Visual Analog Pain Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) before and one week, one month, and three months after the injection. conditions: Gonarthrosis conditions: Meniscus; Degeneration conditions: Pain, Chronic studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 31 type: ACTUAL name: Triamcinolone Hexacetonide name: Dextrose 5% in water measure: Visual Analogue Scale measure: Western Ontario and McMaster University Osteoarthritis Index sex: ALL minimumAge: 40 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gamze Gül Güleç city: Kastamonu zip: 37150 country: Turkey lat: 41.37805 lon: 33.77528 hasResults: False

 nctId: NCT06308874 id: JH-222-101 briefTitle: Phase 1 Study to Investigate Safety, Tolerability, PK/PD of J2H-1702 in Healthy Females overallStatus: COMPLETED date: 2023-01-02 date: 2023-02-17 date: 2023-02-17 date: 2024-03-13 date: 2024-03-13 name: J2H Biotech class: INDUSTRY briefSummary: - Objectives: Primary objective_To evaluate the safety and tolerability after single oral administration of the investigational product (IP), J2H-1702 in healthy female subjects. Secondary objective_To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) characteristics after single oral administration of the IP, J2H-1702 in healthy female subjects. conditions: Non-alcoholic Steatohepatitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 16 type: ACTUAL name: Amg dose administration group name: Amg dose administration group- Placebo name: Bmg dose administration group name: Bmg dose administration group- Placebo measure: Cmax measure: Emax sex: FEMALE minimumAge: 19 Years maximumAge: 45 Years stdAges: ADULT facility: J2H Biotech city: Suwon state: Gyeonggi-do zip: 16684 country: Korea, Republic of lat: 37.29111 lon: 127.00889 hasResults: False

 nctId: NCT06308861 id: JH-201-101 briefTitle: Phase 1 Study to Investigate Safety, Tolerability, PK/PK of J2H-1702 in Healthy Males overallStatus: COMPLETED date: 2020-08-12 date: 2021-06-25 date: 2021-07-13 date: 2024-03-13 date: 2024-03-13 name: J2H Biotech class: INDUSTRY briefSummary: 1. Research Purpose: To evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic properties of J2H-1702 (a candidate for treatment of non-alcoholic steatohepatitis) in healthy men.
2. Design: A dose block-randomized, double-blind, placebo controlled, single- and multiple dosing, dose-escalation phase 1 clinical trial conditions: Non-alcoholic Steatohepatitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ACTUAL name: Single administration Amg dose Group name: Single administration Bmg dose Group name: Single administration Cmg dose Group name: Single administration Dmg dose Group name: Single administration Emg dose Group name: Single administration Amg dose Group-Placebo name: Single administration Bmg dose Group-Placebo name: Single administration Cmg dose Group-Placebo name: Single administration Dmg dose Group-Placebo name: Single administration Emg dose Group-Placebo name: Multiple administration Amg dose group name: Multiple administration Bmg dose group name: Multiple administration Cmg dose group name: Multiple administration Dmg dose group name: Multiple administration Emg dose group name: Multiple administration Amg dose group - Placebo name: Multiple administration Bmg dose group - Placebo name: Multiple administration Cmg dose group - Placebo name: Multiple administration Dmg dose group - Placebo name: Multiple administration Emg dose group - Placebo measure: Cmax measure: Emax sex: MALE minimumAge: 19 Years maximumAge: 45 Years stdAges: ADULT facility: J2H Biotech city: Suwon state: Gyeonggi-do zip: 16684 country: Korea, Republic of lat: 37.29111 lon: 127.00889 hasResults: False

 nctId: NCT06308848 id: PR-22077 briefTitle: Microbiota Directed Food for Children With Severe Acute Malnutrition overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-10-31 date: 2026-12-31 date: 2024-03-13 date: 2024-03-13 name: International Centre for Diarrhoeal Disease Research, Bangladesh class: OTHER name: Washington University School of Medicine briefSummary: Severe acute malnutrition (SAM) refers to a condition characterized by a significant deficit in weight-for-length measurements in children aged 6 to 59 months. It is a crucial public health concern with detrimental effects on child growth, development, and overall well-being. Addressing SAM is crucial to prevent its progression to other childhood morbidity and mortality and to ensure healthy child development. To meet the nutritional requirement of SAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use therapeutic food. The investigators propose this proof-of-concept trial to establish evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with SAM in comparison to the standard RUTF. conditions: Severe Acute Malnutrition studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial (Proof of concept study) primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 256 type: ESTIMATED name: Microbiota-Directed Food name: Ready-to-Use Therapeutic Food measure: Mean change in Weight-for-Length Z-score (WLZ) measure: Gut microbial community repair measure: Improvement in the levels of plasma protein biomarkers of healthy growth measure: Mean change in Weight-for-Age Z-score (WAZ) measure: Mean change in Length-for-Age Z-score (LAZ) measure: Mean change in body composition (% body fat mass and % fat-free mass) sex: ALL minimumAge: 6 Months maximumAge: 24 Months stdAges: CHILD facility: Kurigram Study site city: Kurigram country: Bangladesh name: Md Hasan Hafizur Rahman, MPH, MBBS role: CONTACT phone: 01813333444 email: hasan.hafizur@icddrb.org hasResults: False

 nctId: NCT06308835 id: APHP231652 briefTitle: Prevalence and Risk Factor of Post-intensive Care Syndrome in Neuro-ICU acronym: STRESSréa overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-08 date: 2025-08 date: 2024-03-13 date: 2024-03-18 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Post-intensive care syndrome (PICS) is the set of disabling symptoms that can appear or worsen following a stay in intensive care. These symptoms are physical, cognitive, or psychiatric. The onset and persistence of these symptoms have a major impact on patients' quality of life, their autonomy, and their social and professional reintegration. patients with neurological diseases are frequently excluded from studies due to difficulties for the non-specialist resuscitator to perform the neurological examination and assess whether the symptoms of RPS are secondary to brain damage or complications inherent in resuscitation.The aim of this study is to evaluate the incidence and characteristics of PICS in patients with neurological diseases, at ICU discharge and 3 months after, and to identify the risk factors for developing it. conditions: Post Intensive Care Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: questionnaires measure: Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a physical symptom measure: Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a cognitive symptom measure: Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a psychological symptom measure: Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a psychological symptom. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GH Pitié Salpêtrière city: Paris zip: 75013 country: France name: Clémence Marois, MD, MSc role: CONTACT phone: 0142161858 phoneExt: 33 email: clemence.marois@aphp.fr lat: 48.85341 lon: 2.3488 facility: CH Saint Anne city: Paris zip: 75014 country: France name: Camille Legouy, MD role: CONTACT phone: 0145656200 phoneExt: 33 email: c.legouy@ghu-paris.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06308822 id: NCI-2024-01151 id: NCI-2024-01151 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAY131-K1 type: OTHER domain: ECOG-ACRIN Cancer Research Group id: EAY131-K1 type: OTHER domain: CTEP id: U10CA180820 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180820 briefTitle: Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Amplifications (MATCH-Subprotocol K1) overallStatus: ACTIVE_NOT_RECRUITING date: 2018-06-19 date: 2024-06-30 date: 2024-06-30 date: 2024-03-13 date: 2024-03-13 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II MATCH treatment trial tests how well JNJ-42756493 (erdafitinib) works in treating patients with tumors that have more copies of the FGFR gene than is normal (amplification). Erdafitinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal FGFR protein that signals cancer cells to multiply. conditions: Advanced Lymphoma conditions: Advanced Malignant Solid Neoplasm conditions: Refractory Lymphoma conditions: Refractory Malignant Solid Neoplasm conditions: Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Erdafitinib name: Magnetic Resonance Imaging measure: Objective response rate measure: Overall survival measure: Progression free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ECOG-ACRIN Cancer Research Group city: Philadelphia state: Pennsylvania zip: 19103 country: United States lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06308809 id: Shuzhen Ma briefTitle: Effect of PNF Training as an Intervention for Functional Ankle Instability in College Student overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-05-30 date: 2024-06-20 date: 2024-03-13 date: 2024-03-15 name: Ma Shuzhen class: OTHER briefSummary: The lower limb stability test was carried out by MicroSwing 6.0 gravity center moving trajectory tester made in Germany. conditions: Adolescent Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Single (Participant)

- Page 2 of 5 \[DRAFT\] -In order to avoid mutual interference between the experimental group and the control group, a blinding method needs to be used in the study. In this study, a single blind experiment will be conducted to blind the participating athletes.

During the sample grouping process, participating athletes will not know the specific grouping situation. whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: PNF training measure: CAIT score measure: Lower limb stability test measure: Star offset balance test measure: Muscle strength test sex: MALE minimumAge: 18 Years maximumAge: 23 Years stdAges: ADULT hasResults: False

 nctId: NCT06308796 id: RADIOCARIES2023 briefTitle: Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy acronym: RADIOCARIES overallStatus: RECRUITING date: 2023-04-01 date: 2026-01-31 date: 2026-03-31 date: 2024-03-13 date: 2024-03-15 name: University of Milan class: OTHER briefSummary: One of the long-term side effects of head and neck radiotherapy (RT) is radiation-induced tooth decay. Hyposalivation, associated with radiation therapy, further increases caries susceptibility and caries progression, due to the lack of salivary protective effects and of tooth minerals useful for remineralization processes, especially calcium phosphate (CaP). Dental extractions that could be required in case of severe tooth decay expose the patient to the risk of osteoradionecrosis of the jaws (i.e. the necrosis of the bone tissue following a local trauma, including surgical trauma). This protocol aims at verifying the effectiveness of CaP mousse in the prevention of carious lesions, added to topical fluoride. A randomized controlled clinical trial will be performed comparing CaP + fluoride treatment versus no treatment in head and neck cancer patients, who received radiotherapy. The hypothesis is that CaP, which is lacking in the mouth of these patients due to hyposalivation, can combine with fluoride to promote remineralization, reducing the risk of carious lesions. conditions: Caries,Dental conditions: Head and Neck Cancer conditions: Radiotherapy; Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: Application of CaP dental mousse measure: Number of new cavitated caries per each patient (incidence of caries) measure: Number of extracted teeth per patient (incidence of extracted teeth) measure: Number of patients with a diagnosis of osteoradionecrosis (incidence of osteoradionecrosis) measure: Number of dental surfaces with caries or filling, and missed teeth measure: Rate of dentinal hypersensitivity per patient measure: Rate of dental surface with plaque per patient measure: Rate of bleeding gingival sites per patient sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Univeristy of Milan status: RECRUITING city: Milan zip: 20142 country: Italy name: Elena M Varoni, PhD role: CONTACT phone: +3950319017 email: elena.varoni@unimi.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06308783 id: UFranciscoVitoriaRPGBREATH23 briefTitle: Diaphragmatic Breathing and Global Postural Reeducation on Stress and Sleep Quality in University Students acronym: RPGBREATH23 overallStatus: NOT_YET_RECRUITING date: 2024-05-05 date: 2024-07-17 date: 2024-07-18 date: 2024-03-13 date: 2024-03-13 name: Universidad Francisco de Vitoria class: OTHER briefSummary: Introduction: Nowadays, the reduction of perceived stress and the improvement of sleep quality are considered fundamental aspects in the quality of life of both healthy subjects and patients with disease. Stress has become a pandemic in recent years due to the socio-labor demands faced by society. On the other hand, it has a direct relationship with the quality of sleep, its influence being bidirectional. In this regard, several tools have been reported for the management of these conditions. These include strategies such as yoga, mindfulness, diaphragmatic breathing (DR) or Pilates. On the other hand, other proposals such as global postural reeducation (GPR) lack evidence in the management of these conditions.

Objectives: Compare the effects of a diaphragmatic breathing self-management program with global postural reeducation on stress and sleep quality in university students.

Method: The study will be carried out with physiotherapy students of the University Francisco de Vitoria. The participants will be randomly divided into three groups: GPR group, DR group and control group. Perceived stress (Perceived Stress Scale - PSS14) and reported sleep quality (Pittsburgh Sleep Quality Index - PSQI) will be measured three times throughout the study: pre-intervention, 3 weeks after the start of the intervention and post-intervention. The intervention will last 6 weeks, during which time all participants will be required to complete the 5 Grade Scale (5GS) each morning. The GPR group will perform; Frog to the ground posture, while the DR group will follow a set breathing protocol at a 4/6 rhythm. Both GPR and DR will be performed 10 minutes before going to sleep.

Ethical considerations:

The principles of the 1964 Declaration of Helsinki will be followed. The proposed interventions are non-invasive, based on the combination of mild physical activity tools, body awareness and relaxation techniques.

The dependent variables to be measured are based on clinimetric aspects, without any harm to the participants.

Subjects will be asked to participate on a voluntary basis and may withdraw from the study at any time. conditions: Stress conditions: Sleep Disturbance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: One group receives Diaphragmatic Breathing, one group receives Global Postural Reeducation, and the other group receives no intervention. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 33 type: ESTIMATED name: Diaphragmatic Breathing name: Global Postural Reeducation measure: Stress measure: Sleep Quality measure: Sleep Quality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06308770 id: AC21137 briefTitle: Fatigue in Lupus Intervention Programmes (FLIP) acronym: FLIP overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04 date: 2027-04 date: 2024-03-13 date: 2024-03-13 name: University of Edinburgh class: OTHER name: Accord Clinical Research briefSummary: Systemic Lupus Erythematosus (SLE) is an autoimmune rheumatic disease. Patients report that fatigue has a significant impact on their quality of life but is often not discussed in healthcare settings. Fatigue is more prevalent in SLE than other Rheumatic diseases. Management across the NHS is very variable ranging from a booklet to one to one appointments or, less often, a group intervention. Previous studies in other Rheumatic diseases have shown that a group cognitive behavioural approach can be effective in helping patients manage their fatigue. The COVID-19 pandemic changed the way healthcare is delivered in the NHS . Healthcare professionals had to find alternate solutions e.g. Virtual appointments.

Our study aims to establish whether a virtual group Fatigue Management Programme and a fatigue booklet (Versus Arthritis and Lupus UK) is more effective at reducing the impact of fatigue in SLE participants than the fatigue booklet alone.

The investigators will also compare a shortened 4-week to the standard 7-week programme to lessen the time commitment for participants and potentially reduce waiting times.The investigators will measure the effectiveness of the interventions through the use of Patient Reported Outcome Measures (PROMs) at several intervals whilst the participant is enrolled in the study.The pilot study will run in a single site in Edinburgh. The investigators aim to find a manageable, cost effective solution for the NHS and patients to address this frequently unmet need. conditions: Systemic Lupus Erythematosus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The pilot study for the FLIP trial is a single centre three arm, randomised controlled trial (RCT) comparing the effectiveness of a virtual group fatigue management intervention with standard care in SLE participants. Participants will self-enrol via a secure database and then be randomised electronically to one of the three interventions;

1. Standard care (SC) - Lupus UK and Versus Arthritis Booklets
2. SC and 4 week Fatigue management Programme (FMP)
3. SC and 7 week FMP Results will be measured by comparing Patient Reported Outcome measures (PROMs) submitted before and after the intervention and, at 6 and 12 months. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The statistician who analyses the results will be blind to the intervention to which the participant was randomised. whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Standard Care name: 4 week FMP name: 7 week FMP measure: Modified Fatigue Impact Score (MFIS) measure: Lupus quality of life questionnaire (LupusQoL) measure: Pittsburgh Sleep quality Inventory ( PSQI) measure: Visual Analog scale of fatigue impact (FI-VAS) measure: Participant Health Questionnaire (PHQ4) measure: Self-Efficacy for Managing Chronic Diseases 6-item Scale measure: Quick Systemic Lupus Erythematosus Activity Questionnaire (Q-SLAQ) measure: Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06308757 id: 495/2021/Sper/AOUBo briefTitle: Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis acronym: KETONASH overallStatus: RECRUITING date: 2021-09-29 date: 2024-11-24 date: 2026-12-12 date: 2024-03-13 date: 2024-03-15 name: University of Bologna class: OTHER briefSummary: The purpose of the KETONASH study is to evaluate, in patients with metabolic-associated fatty liver disease (MAFLD) with non-alcoholic steatohepatitis (NASH) and significant liver fibrosis, the effect of a very low-calorie ketogenic diet (VLCKD) compared to that of a standard low-calorie diet (standard Mediterranean LCD - in accordance with the European Association for the Study of the Liver/European Society for Clinical Nutrition and Metabolism guidelines on MAFLD/NAFLD). conditions: NASH conditions: NAFLD conditions: Obesity conditions: Liver Fibrosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicentric, Prospective, Open, Randomized, Controlled, and Interventional, with no medicinal use primaryPurpose: TREATMENT masking: NONE maskingDescription: Two-arms, 2: 1 randomization stratified by type 2 diabetes mellitus and gender count: 42 type: ESTIMATED name: Very-low-calorie ketogenic diet (VLCKD) with meal replacements name: Mediterranean low-calorie diet (LCD) measure: Change of at least one grade of liver fibrosis measure: Change of histological features of NASH measure: Histological NIH NASH CRN Score measure: Histological FLIP/SAF changes measure: Biochemical test changes 1 measure: Biochemical test changes 2 measure: Biochemical test changes 3 measure: Biochemical test changes 4 measure: Biochemical test changes 5 measure: Biochemical test changes 6 measure: Biochemical test changes 7 measure: Biochemical test changes 8 measure: Biochemical test changes 9 measure: Biochemical test changes 10 measure: Biochemical test changes 11 measure: Biochemical test changes 12 measure: Biochemical test changes 13 measure: Fibrosis-4 test (FIB-4 ) variation measure: NAFLD Fibrosis Score (NFS) change measure: FAST (FibroScan-AST) score variation measure: Fatty Liver Index (FLI) modification measure: Changes in LSM measure: Variation of steatosis by CAP measure: Body Mass Index (BMI) improvement measure: Side effects evaluation for VLCKD therapy by VAS (Visual Analogue Scale) measure: Compliance to VLCKD evaluated by VAS (Visual Analogue Scale) measure: Variation of steatosis by ultrasound assessment measure: Questionnaires 1 measure: Questionnaires 2 measure: Questionnaires 3 measure: Questionnaires 4 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna status: RECRUITING city: Bologna zip: 40138 country: Italy name: Federico Ravaioli role: CONTACT phone: +393333176759 email: f.ravaioli@unibo.it name: Sofia Penazza role: CONTACT phone: 0512142477 email: sofia.penazza2@unibo.it name: Federico Ravaioli, MD, PhD role: SUB_INVESTIGATOR name: Maria Letizia Petroni, Professor role: SUB_INVESTIGATOR name: Fabio Piscaglia, Professor role: PRINCIPAL_INVESTIGATOR name: Silvia Ferri, MD role: SUB_INVESTIGATOR name: Simona Leoni, MD role: SUB_INVESTIGATOR lat: 44.49381 lon: 11.33875 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-11-23 uploadDate: 2024-02-19T03:31 filename: Prot_SAP_000.pdf size: 368757 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-14 uploadDate: 2024-02-19T03:32 filename: ICF_001.pdf size: 47308 hasResults: False

 nctId: NCT06308744 id: 2021-5212-4387 briefTitle: A Large Multi-site Study on Self-administered Mindfulness overallStatus: COMPLETED date: 2022-03-23 date: 2022-06-30 date: 2022-06-30 date: 2024-03-13 date: 2024-03-15 name: Swansea University class: OTHER name: Université Grenoble-Alpes name: University of Utah name: Seeburg University name: Ludwig-Maximilians - University of Munich name: University of Houston name: Loyola Marymount University name: Ashland University name: The College at Brockport name: Medical University of South Carolina name: Australian National University name: The University of Queensland name: University of North Florida name: University of Wuerzburg name: Iowa State University name: Goldsmiths, University of London name: Pennsylvania Western University name: University of Konstanz name: Springfield College name: Glendale Community College name: St. Olaf College name: University of Limerick name: Northumbria University name: Wittenberg University Ohio name: University of Edinburgh name: University of California, Merced name: University of Southern Indiana name: Pace University name: Toronto Metropolitan University name: Wayne State University name: Memorial University of Newfoundland name: University College, London name: DigiPen Institute of Technology Redmond name: University of Canberra name: University of Northern Iowa name: Idaho State University name: Behavioural Science Institute name: Radboud University Medical Center name: Eastern Oregon University name: Charles University, Czech Republic name: University of Milano Bicocca name: Spiessens Coaching Solutions Ltd briefSummary: The use of self-administered mindfulness interventions has increased in recent years. The effectiveness of these interventions on regulating stress/emotions, however, is debated. In the present multi-site study (Nsites = x, Nparticipants = x), the investigators aimed to investigate the effectiveness of four single, brief stand-alone mindfulness exercises in a population unfamiliar with mindfulness meditation. The investigators tested these four interventions in comparison to non-mindful active control conditions using an adaptive Bayesian design. The investigators found \[evidence for the efficacy of x exercises/no evidence for the efficacy of x exercises\] with an estimated mean effect size of \[xx/xx\]. This means that... or The investigators recommend that... \[recommendation will be provided\]. conditions: Body Scan Meditation conditions: Loving-Kindness Meditation conditions: Mindful Breathing Meditation conditions: Mindful Walking Meditation conditions: Control Condition studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The current multi-site project followed the route of a parallel randomized controlled trial. Each participant was randomly allocated to either an experimental condition corresponding to a 15-minute audio listening of one of four different mindfulness exercises (i.e., mindful walking, mindful breathing, body scan and loving kindness meditation) or to a control condition (i.e., listening to a 15-minute audio story excerpt). Participants who were assigned to the control group randomly listened to an excerpt of one of the three stories that the investigators selected for the present study. primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Participants were not aware of the experimental condition in which they were randomly allocated. Data collection was performed blind to the experimental conditions, but data analysis was not performed blind. However, given that all analyses were pre-registered, it is unlikely that the lack of blinding in data analysis introduced bias. whoMasked: PARTICIPANT count: 2239 type: ACTUAL name: Body-scan meditation name: Mindful Breathing meditation name: Loving Kindness meditation name: Mindful Walking name: Listening of a story measure: Stress measure: Emotion dimensions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Swansea University city: Swansea state: Wales, UK zip: SA2 8PP country: United Kingdom lat: 51.62079 lon: -3.94323 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2022-03-22 uploadDate: 2024-03-05T01:50 filename: Prot_SAP_000.pdf size: 606904 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2021-11-05 uploadDate: 2024-03-05T01:51 filename: ICF_001.pdf size: 240389 hasResults: False

 nctId: NCT06308731 id: 23-26 briefTitle: Exercise-Induced Rates of Fat Oxidation With and Without Ingestion of a Caffeine-Based Energy Drink acronym: EDX overallStatus: RECRUITING date: 2024-01-19 date: 2024-07-01 date: 2024-07-01 date: 2024-03-13 date: 2024-03-13 name: Lindenwood University class: OTHER briefSummary: The purpose of this study is to evaluate acute changes in rates of fat oxidation during exercise with and without the ingestion of a caffeine-based energy drink. conditions: Substrate Oxidation conditions: Energy Expenditure conditions: Reaction Time conditions: Cognition conditions: Exercise Performance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Double-blind, placebo controlled, crossover design primaryPurpose: OTHER masking: DOUBLE maskingDescription: All energy drink supplements are provided in identical, unlabeled cans, using a randomization code. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 15 type: ESTIMATED name: Caffeine-Based Energy Drink name: Placebo measure: Impact of a caffeine-based energy drink ingestion on fat oxidation rates during exercise. measure: Impact of a caffeine-based energy drink ingestion on energy expenditure rates during exercise. measure: Impact of a caffeine-based energy drink ingestion on carbohydrate oxidation during exercise measure: Impact of a caffeine-based energy drink ingestion on plasma glycerol concentration measure: Impact of a caffeine-based energy drink ingestion on plasma free fatty acid concentration measure: Impact of a caffeine-based energy drink ingestion on ratings of perceived exertion measure: Impact of a caffeine-based energy drink ingestion on exercise performance measure: Impact of a caffeine-based energy drink ingestion on reaction time measure: Impact of a caffeine-based energy drink ingestion on trail making test performance measure: Impact of a caffeine-based energy drink ingestion on Cognition measure: Impact of a caffeine-based energy drink ingestion on adverse events measure: Impact of a caffeine-based energy drink ingestion on heart rate measure: Impact of a caffeine-based energy drink ingestion on blood pressure sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Exercise and Performance Nutrition Laboratory status: RECRUITING city: Saint Charles state: Missouri zip: 63301 country: United States name: Anthony M Hagele, MS role: CONTACT phone: 636-949-4785 email: ahagele@lindenwood.edu name: Joesi M Krieger, MS role: CONTACT phone: 636-949-4785 email: jkrieger@lindenwood.edu name: Chad M Kerksick, PhD role: PRINCIPAL_INVESTIGATOR lat: 38.78394 lon: -90.48123 hasResults: False

 nctId: NCT06308718 id: FBX-101-LTFU briefTitle: Long-term Follow-up Study to Evaluate Safety and Efficacy of FBX-101 in Krabbe Patients overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2029-12 date: 2029-12 date: 2024-03-13 date: 2024-04-26 name: Forge Biologics, Inc class: INDUSTRY briefSummary: This is an observational study that will enroll any patients with Krabbe disease that have participated in prior interventional clinical trials involving the administration of FBX-101. conditions: Krabbe Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: FBX-101 measure: Long Term safety as assessed by incidence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) that are attributed to FBX-101 measure: Efficacy as assessed by change of gross motor function measured longitudinally by Peabody Developmental Motor Scale (PDMS-2) measure: Efficacy as assessed by change of gross motor function measured longitudinally by Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) measure: Efficacy as assessed by change of gross motor function measured longitudinally by Gross Motor Function Measure 88 (GMFM-88) measure: Efficacy as assessed by change of fine motor function measured longitudinally by Mullen Scales of Early Learning (MSEL) measure: Efficacy as assessed by change of fine motor function measured longitudinally by Beery VMI Sixth Edition (VMI) measure: Efficacy as assessed by change of fine motor function measured longitudinally by Bayley Scales of Infant Development (Bayley-III) measure: Efficacy as assessed by change of fine motor function measured longitudinally by Vineland Adaptive Behavior Scale (Vineland 3) measure: Efficacy as assessed by change of cognitive function measured longitudinally by Mullen Scales of Early Learning (MSEL) measure: Efficacy as assessed by change of cognitive function measured longitudinally by the Differential Ability Scale II (DAS-II) measure: Efficacy as assessed by change of cognitive function measured longitudinally by Bayley Scales of Infant Development (Bayley-III) measure: Efficacy as assessed by change of adaptive behaviour function measured longitudinally by Vineland Adaptive Behavior Scale (Vineland 3). measure: Efficacy as assessed by change of language function measured longitudinally by Mullen Scales of Early Learning (MSEL). measure: Efficacy as assessed by change of language function measured longitudinally by Clinical Evaluation of Language Fundamentals Fifth Edition (CELF-5) measure: Efficacy as assessed by change of language function measured longitudinally by Bayley Scales of Infant Development (Bayley-III) measure: Efficacy as assessed by change of language function measured longitudinally by Vineland Adaptive Behavior Scale (Vineland 3). measure: Efficacy as assessed by change of quality of life measured longitudinally by the Pediatric Quality of Life (PedsQL) Generic Core Scales with Family Impact Module and Multidimensional Fatigue Scale measure: Efficacy as assessed by change of developmental milestones such as language and motor skills as measured longitudinally by an specific Developmental Milestones questionnaire measure: Efficacy as assessed by change of hearing function measured longitudinally by Auditory Brainstem Responses (ABRs) measure: Efficacy as assessed by change of hearing function measured longitudinally by Behavior Audiometry (BAUD) measure: Efficacy as assessed by change of peripheral nerve conduction velocity measured longitudinally by Nerve Conduction Velocity (NCV) assessments measure: Efficacy as assessed by change of Fractional Anisotropy (FA) as measured longitudinally by brain Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) measure: Efficacy as assessed by change of visual function as measured longitudinally by visual evoked potentials (VEP) measure: Efficacy as assessed by change of visual function as measured longitudinally by visual acuity measure: Efficacy as assessed by change of whole blood donor chimerism measure: Efficacy as assessed by change of psychosine in whole blood and plasma measure: Efficacy as assessed by change of Galactosylceramidase (GALC) levels in plasma and Cerebrospinal Fluid (CSF) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06308705 id: 2022-19 briefTitle: The SsRI/NIE Recombinant Antigen ELISA for the Follow up of Patients Infected by Strongyloides Stercoralis overallStatus: COMPLETED date: 2023-06-06 date: 2023-10-18 date: 2023-10-18 date: 2024-03-13 date: 2024-03-13 name: IRCCS Sacro Cuore Don Calabria di Negrar class: OTHER briefSummary: This is a single-center interventional study with an IVD medical device.

The main objective of this study is to evaluate the ELISA SsIR/NIE test for the post-treatment follow-up of patients suffering from strongyloidosis, using well-characterized sera from a previous study.

All sera available in the Tropica biobank and coming from the Strong Treat study, for which serum samples collected at baseline and at 12-month follow-up are available, will be eligible for the study.

The test The InBios Strongy Detect TM IgG ELISA detects specific IgG antibodies against recombinant Strongyloides NIE and SsIR antigens in serum. It consists of an enzymatically amplified sandwich immunoassay. Positive and negative control samples are provided in the kit. The test will be performed and interpreted according to the manufacturer's instructions. The results are expressed as OD and nOD. Clinical interpretation of the results will be performed by receiver operating characteristic (ROC) curve analysis generated using data from confirmed positive and confirmed negative samples.

The laboratory technicians will receive from the PI of the study a list of pseudo-anonymized sera to be tested with SsIR/NIE ELISA, they will check their availability and proceed with the test according to the Manufacturer's instructions. Laboratory personnel performing and reading the tests will be blinded to the results of any previously performed tests (and the classification of the sample in the Strong Treat study). A single run will be performed for each sample, unless the test needs to be repeated due to any technical problem. Both baseline and follow-up sera will be tested. The resulting OD and nOD will be reported in an Excel file by the laboratory technicians performing the tests. conditions: Strongyloides Stercoralis Infection studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 38 type: ACTUAL name: InBios Strongy Detect TM IgG ELISA measure: Result of the SsIR/NIE ELISA measure: Seroconversion sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Sacro Cuore Don Calabria hospital city: Negrar state: Verona zip: 37024 country: Italy lat: 45.52918 lon: 10.93899 hasResults: False

 nctId: NCT06308692 id: 2022-11 briefTitle: Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Real Time PCR-ARES PCR Methods overallStatus: RECRUITING date: 2022-06-28 date: 2024-12 date: 2024-12 date: 2024-03-13 date: 2024-03-13 name: IRCCS Sacro Cuore Don Calabria di Negrar class: OTHER briefSummary: Experimental study without drug and device, on pseudo-anonymized samples archived at the Tropica Biobank.

The objective is to evaluate the performance for the identification of microorganisms in blood samples and rectal swabs of real time PCR assays for the targets: KPC, VIM, IMP, NDM, Acinetobacter OXA, Oxa48, MCR.

The evaluations will be carried out taking into consideration the data obtained from the diagnostic routine at the DITM. conditions: Drug Resistant Bacterial Infection studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: ARES PCR measure: PCR results measure: Gene mutations sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Sacro Cuore Don Calabria hospital status: RECRUITING city: Negrar state: Verona zip: 37024 country: Italy name: Elena Pomari role: CONTACT phone: +390456013111 email: elena.pomari@sacrocuore.it name: Elena Pomari role: PRINCIPAL_INVESTIGATOR name: Pierantonio Orza role: SUB_INVESTIGATOR name: Francesca Perandin role: SUB_INVESTIGATOR lat: 45.52918 lon: 10.93899 hasResults: False

 nctId: NCT06308679 id: BE 001-24 briefTitle: A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers Under Fasting Conditions overallStatus: NOT_YET_RECRUITING date: 2024-05-28 date: 2024-05-31 date: 2024-06-07 date: 2024-03-13 date: 2024-03-13 name: Pharma Nueva class: INDUSTRY briefSummary: Objectives:

Primary:

to evaluate the bioequivalence of two formulations of Empagliflozin tablets, test formulation and reference innovator formulation, after a single oral dose administration in healthy Thai subjects under fasting conditions

Secondary:

To examine the pharmacokinetics and safety of test and reference formulations

Study Design:

A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers under Fasting Conditions conditions: Healthy Vollunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 28 type: ESTIMATED name: Empagliflozin 10 mg tablets name: JARDIANCE® measure: Plasma area Under the Curve (AUC(0-48hr)) for Empagliflozin measure: Peak Plasma Concentration (Cmax) of Empagliflozin sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06308666 id: 46091 briefTitle: Performance of DAILIES TOTAL1 Daily Disposable Contact Lenses in Habitual Soft Lens Wearers Who Report Substantial Digital Device Use acronym: FOX overallStatus: RECRUITING date: 2024-03-18 date: 2024-07-18 date: 2024-07-18 date: 2024-03-13 date: 2024-03-22 name: University of Waterloo class: OTHER name: Alcon Research briefSummary: The purpose of this study is to evaluate the performance of DAILIES TOTAL1 daily disposable contact lenses with regards to subjective symptoms (comfort, dryness, vision) in lens wearers who use identify themselves as substantial digital device users (at least eight hours of digital device use per day). conditions: Myopia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Delefilcon A contact lenses measure: Subjective Rating of Comfort After 8 Hours or More of Digital Device Use measure: Subjective Rating of Dryness After 8 Hours or More of Digital Device Use measure: Subjective Rating of Clarity of Vision After 8 Hours or More of Digital Device Use sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Centre for Ocular Research & Education status: RECRUITING city: Waterloo state: Ontario zip: N2L 3G1 country: Canada name: Jill Woods, McOptom role: CONTACT phone: 519-888-4567 phoneExt: 36743 email: jwoods@uwaterloo.ca name: Lyndon Jones, PhD, FCoptom role: PRINCIPAL_INVESTIGATOR lat: 43.4668 lon: -80.51639 hasResults: False

 nctId: NCT06308653 id: PSIL301 briefTitle: Psilocybin for Major Depressive Disorder (MDD) acronym: uAspire overallStatus: RECRUITING date: 2024-03-05 date: 2025-04 date: 2026-04 date: 2024-03-13 date: 2024-03-26 name: Usona Institute class: OTHER briefSummary: Approximately 240 eligible adult participants (≥18 years old) who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria for Major Depressive Disorder (MDD) will be enrolled. Participants will be randomly assigned to receive a single oral dose of Psilocybin 25 mg, Psilocybin 5 mg, or inactive placebo.

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Psilocybin 25 mg versus placebo in adults with MDD, as assessed by the difference between groups in change in depressive symptoms from Baseline to Day 43 post-dose, and to characterize the durability of initial treatment effect and subsequent response to optional Psilocybin 25 mg re-administration(s) during the 1-year Follow-up Period. conditions: Depressive Disorder, Major studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to receive Psilocybin 25 mg, Psilocybin 5 mg, or inactive placebo under double-blind conditions. After the initial 6-week Double-blind Period, all participants will proceed into a 1-year Follow-up Period. During this 1-year Follow-up Period, eligible participants who meet pre-determined criteria may be offered open-label Psilocybin 25 mg in the context of a "Set and Setting" (SaS) Protocol. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The following roles will be blinded to the treatment group assignment in the Double-blind Period during the trial: Participant, Investigator, Site Personnel, Facilitators, Efficacy Raters (including Site Raters, Participant Raters, and Central Raters), Contract Research Organization (CRO) Staff, and Sponsor.

All roles other than the Sponsor, CRO, and Ethics Committees will also be blinded to the randomization ratio and Patient Health Questionnaire-9 (PHQ-9) score for re-administration eligibility.

The Central MADRS Rater will also be blinded to all aspects of the protocol and trial visit for each participant.

Blinded trial site personnel will complete administration of the IP.

Full blinding of trial personnel, Sponsor, and participants will be maintained until database lock at the conclusion of the trial. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 240 type: ESTIMATED name: Psilocybin 25 mg name: Inactive Placebo name: Psilocybin 5 mg name: Psychosocial Support measure: Change in central rater Montgomery-Asberg Depression Rating Scale (MADRS) total score from Baseline to Trial Day 43 measure: Change in central rater Clinical Global Impression-Severity (CGI-S) total score from Baseline to Trial Day 43 measure: Change in on-site rater administered Sheehan Disability Scale (SDS) score from Baseline to post-dose Day 43 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mountain View Clinical Research status: RECRUITING city: Denver state: Colorado zip: 80209 country: United States name: Brian Johnson role: CONTACT phone: 720-941-9363 phoneExt: 703 email: Brian@mtnresearch.com name: David Weiss, MD role: PRINCIPAL_INVESTIGATOR lat: 39.73915 lon: -104.9847 facility: Innovative Clinical Research, Inc. status: RECRUITING city: Lauderhill state: Florida zip: 33319 country: United States name: Shelbie Bobrow role: CONTACT phone: 954-769-1397 email: sbobrow@segaltrials.com name: Louis Sotolongo role: CONTACT phone: 954-769-1397 email: lsotolongo@segaltrials.com name: Rishi Kakar, MD role: PRINCIPAL_INVESTIGATOR lat: 26.14036 lon: -80.21338 facility: Cedar Clinical Research status: RECRUITING city: Draper state: Utah zip: 84020 country: United States name: Jane Bjorklund role: CONTACT phone: 801-369-4219 email: jane.bjorklund@numinus.com name: Reid Robison, MD role: PRINCIPAL_INVESTIGATOR lat: 40.52467 lon: -111.86382 facility: Cedar Clinical Research, Inc. status: RECRUITING city: Murray state: Utah zip: 84107 country: United States name: Jane Bjorklund role: CONTACT phone: 801-369-4219 email: jane.bjorklund@numinus.com name: Paul Thielking, MD role: PRINCIPAL_INVESTIGATOR lat: 40.66689 lon: -111.88799 hasResults: False

 nctId: NCT06308640 id: ORTH 11-23 2097 briefTitle: Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-10 date: 2026-01-10 date: 2026-01-10 date: 2024-03-13 date: 2024-03-13 name: Tanta University class: OTHER briefSummary: The goal of this clinical trial is to to evaluate and compare the skeletal and dental changes of bone supported Fast Back and bone supported modified Leaf Spring Self-Activated Expander in bilateral distalization of maxillary molars using CBCT in Egyptian people. The main question it aims to answer are: • If bone supported Fast Back and bone supported modified Leaf Spring Self-Activated Expander will be effective in bilateral distalization of maxillary molars

The patients will be selected according to the following criteria:

1. Patient with full permanent dentition.
2. Good oral hygiene.
3. None of the patients had received any orthodontic treatment.
4. Class II molar relationship.
5. Minimal or no crowding in the mandibular arch.
6. Non-extraction treatment plan with molar distalization.
7. Low angle cases.
8. No medical problems or active periodontal disease.

Researchers will compare between bone supported Fast Back appliance and bone supported modified Leaf Spring Self-Activated and see if they will be effective in maxillary molars distalization. conditions: Class II Malocclusion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The purpose of this study is to evaluate and compare the treatment effects of two bone supported protocols for bilateral distalization of maxillary molars in patients exhibiting class II pattern using Fast Back appliance and modified Leaf Spring Self-Activated Expander primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ACTUAL name: Insertion of the device intraorally measure: 3D Dental and skeletal Cephalometric Measurements measure: 2D Dental and skeletal Cephalometric Measurements sex: ALL minimumAge: 14 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Faculty of Dentistry city: Tanta state: Gharbia zip: 6620010 country: Egypt lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06308627 id: K2022-03-074 briefTitle: A One-year Trajectory of Depression Status Changes in Elderly Patients With MCI and SD: a Longitudinal Cohort Study overallStatus: RECRUITING date: 2023-06-01 date: 2024-07-01 date: 2024-07-01 date: 2024-03-13 date: 2024-03-13 name: Fujian Medical University class: OTHER briefSummary: The purpose of this study is to investigate the one-year trajectory of changes in depression status in elderly patients with mild cognitive impairment and subthreshold depression, and to explore relevant risk factors for predicting changes in depression status. This one-year prospective longitudinal follow-up study involved 400 (expected) subjects who met the diagnostic criteria for mild cognitive impairment combined with subthreshold depression in the elderly, and their depressive status was assessed using the Geriatric Depression Scale (GDS). Follow up monitoring of depression status at 6 and 12 months. Obtain factors related to changes in depressive status (such as age, gender, education level, cognitive function, anxiety level, sleep status, social support, psychological resilience, social network, etc.). By studying the longitudinal trajectory of depression status in elderly patients with mild cognitive impairment and subthreshold depression, a multi state Markov model with time and state discreteness is constructed, namely: State 1 (normal); State 2 (subliminal depression); State 3 (mild depression); State 4 (moderate depression); State 5 (severe depression). Deeply explore and analyze the impact of certain factors and indicators on the transition between states, and estimate the probability of transition between states. conditions: Mild Cognitive Impairment conditions: Subthreshold Depression conditions: Older Adults studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: Depressive state measure: General information of patients measure: Cognitive measure: Cognitive measure: Activity of Daily Living measure: Anxiety measure: Social Function measure: Social Function measure: Sleep Quality measure: Resilience sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian provincial hospital status: RECRUITING city: Fuzhou state: Fujian zip: 350000 country: China name: Hong Li role: CONTACT phone: 18120826271 email: leehong99@126.com lat: 26.06139 lon: 119.30611 hasResults: False

 nctId: NCT06308614 id: MIT-Do001-C206 briefTitle: Estetrol for the Treatment of Female Sexual Arousal Disorder in Postmenopausal Women overallStatus: RECRUITING date: 2024-01-29 date: 2024-12 date: 2024-12 date: 2024-03-13 date: 2024-03-13 name: Estetra class: INDUSTRY briefSummary: The goal of this clinical trial is investigating estetrol (E4) in women after menopause, suffering from sexual arousal disorder. The main question it aims to answer is: is 20 mg estetrol monohydrate effective in the treatment of sexual arousal disorder in women after their menopause. Participants will visit the clinic 7 times and complete a daily diary while receiving estetrol or placebo for 12 weeks. Placebo is a pill that looks the same as estetrol but has no active ingredient. Researchers will compare estetrol and placebo to see if estetrol has an effect on the sexual arousal of the participants. conditions: Sexual Dysfunction, Physiological studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: 20 mg estetrol monohydrate name: Placebo measure: Change from Baseline to Week 12 in feeling concerned by difficulties with sexual arousal, assessed by FSDS-DAO Item 14. measure: Change from Baseline to Week 12 in the Sexual Function Questionnaire 28 (SFQ-28) Arousal-Sensation Domain (Questions 6 to 9). measure: Change from Baseline to Week 12 in arousal and lubrication assessed by Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction (SexFS) measures (PROMISSexFS Questionnaire). measure: Change from Baseline to Week 12 in sexual function assessed by FSDS-DAO - total score. measure: Change from Baseline to Week 12 in sexual function assessed by Percentage of Satisfying Sexual Events (SSE) - captured in arousal electronic diary (ediary). measure: Change from Baseline to Week 12 in sexual function assessed by SFQ-28 - total score. measure: Change from Baseline to Week 12 in sexual function assessed by PROMIS-SexFS. measure: Patient Global Impression of Change (PGIC) at Week 12. measure: Change from Baseline to Week 12 in severity of sexual arousal disorder as assessed by Patient Global Impression of Severity (PGIS). measure: Frequency of treatment emergent adverse events (TEAEs) (including treatment-emergent serious adverse events [TESAEs]). measure: Blood pressure (systolic and diastolic) at each measured time point. measure: Respiratory rate at each measured time point. measure: Heart rate at each measured time point. sex: FEMALE minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Estetra Study Site status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85032 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 33.44838 lon: -112.07404 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Tucson state: Arizona zip: 85715 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 32.22174 lon: -110.92648 facility: Estetra Study Site status: NOT_YET_RECRUITING city: San Diego state: California zip: 92111 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 32.71533 lon: -117.15726 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Jacksonville state: Florida zip: 32256 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 30.33218 lon: -81.65565 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33173 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 25.77427 lon: -80.19366 facility: Estetra Study Site status: NOT_YET_RECRUITING city: New Port Richey state: Florida zip: 34652 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 28.24418 lon: -82.71927 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Orlando state: Florida zip: 32801 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 28.53834 lon: -81.37924 facility: Estetra Study Site status: RECRUITING city: West Palm Beach state: Florida zip: 33409 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 26.71534 lon: -80.05337 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Sandy Springs state: Georgia zip: 30328 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 33.92427 lon: -84.37854 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Omaha state: Nebraska zip: 68114 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 41.25626 lon: -95.94043 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Las Vegas state: Nevada zip: 89109 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 36.17497 lon: -115.13722 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Albuquerque state: New Mexico zip: 87102 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 35.08449 lon: -106.65114 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Englewood state: Ohio zip: 45322 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 39.87756 lon: -84.30217 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Memphis state: Tennessee zip: 38119 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 35.14953 lon: -90.04898 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Memphis state: Tennessee zip: 38120 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 35.14953 lon: -90.04898 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77061 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 29.76328 lon: -95.36327 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77074 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06308601 id: 23-12.1T/60 briefTitle: The Effect of Laughter Yoga on Loneliness, Anger and Salivary Cortisol Levels in Visually Impaired Individuals overallStatus: ENROLLING_BY_INVITATION date: 2024-05-16 date: 2024-06-04 date: 2024-06-27 date: 2024-03-13 date: 2024-03-13 name: Ege University class: OTHER briefSummary: Purpose: This project aimed to examine the effects of laughter yoga, which is accepted as an international nursing initiative, on loneliness, anger and salivary cortisol levels in visually impaired individuals. When the national and international literature was examined, no project was found that measured the results of laughter yoga as an intervention for visually impaired individuals. For this reason, planning an original project in this field aims to contribute to the literature. Thanks to the evidence obtained, laughter yoga, an innovative approach, can be disseminated in institutions and organizations serving visually impaired individuals as an evidence-based practice that can improve the social skills of individuals.

Scope and Target Audience: The project will be carried out with visually impaired individuals receiving services in the Disabled Persons Department within the Atatürk Provincial Public Library located in Konak district of Izmir. In this section, services are provided to 250 members who actively use the library and to visually impaired people from all over Turkey.

Method and Expected Result: The project was planned in a randomized controlled, pre-test post-test, single-blind follow-up consultancy design. With this initiative, a social rehabilitation environment will be provided for visually impaired individuals by taking an approach based on respect, understanding and awareness. Laughter yoga is expected to reduce the level of anger and loneliness in visually impaired individuals. At the same time, laughter yoga is expected to reduce cortisol levels, which are known to increase when faced with stress factors, and increase serotonin, which is associated with happiness and vitality, and endorphine, known as the body's natural painkiller. With laughter yoga sessions, a social environment will be created where visually impaired individuals will have an active and independent experience. Thanks to the expected evidence, laughter yoga can be popularized both in visually impaired individuals and in individuals with other disabilities. Within the scope of protecting and improving health, laughter yoga can be planned to be carried out as a routine nursing practice in disabled centers. Thus, by creating an environment where visually impaired individuals and nurses come together, a more accessible health service will be provided to individuals with special needs. conditions: Nursing Caries conditions: Laughter conditions: Visual Impairment conditions: Loneliness conditions: Anger studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Research Population: The population of this research is the visually impaired individuals who received service from the Disabled Department within the Ataturk Provincial Public Library in Konak district of Izmir province between 2023-2024.

Research Sample: In the research, "G. Using the "Power-3.1.9.7" program, the sample size of the study was calculated at a 95% confidence level before the data collection phase. The standardized effect size was found to be 0.90 when calculated based on the mean and standard deviation values of previous studies. As a result, the minimum number of samples was calculated as 28 for each group with a 95% confidence level, 0.05 alpha value, 0.90 intervention effect size and 95% theoretical power. It is aimed to reach 56 people in total. Considering that there will be a 20% case loss in experimental studies in the literature (Pan, et al., 2019), the number of samples was determined as 60 (30 interventions; 30 controls). primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Statistical evaluation of the research results will be made by an expert other than the researcher. whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Laughter yoga measure: salivary cortisol test measure: UCLA(University of California, Los Angeles) Loneliness Scale measure: Trait Anger Scale sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Ege University city: Bornova state: İ̇zmi̇r zip: 35030 country: Turkey lat: 38.47921 lon: 27.2399 hasResults: False

 nctId: NCT06308588 id: 2024-0054 id: NCI-2024-02121 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-09-30 date: 2027-05-01 date: 2029-05 date: 2024-03-13 date: 2024-04-29 name: M.D. Anderson Cancer Center class: OTHER name: Novartis Pharmaceuticals briefSummary: To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL. conditions: Philadelphia Chromosome-Positive conditions: Acute Lymphoblastic Leukemia studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Blinatumomab name: Asciminib measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Nicholas Short, MD role: CONTACT phone: 713-563-4485 email: nshort@mdanderson.org name: Nicholas Short, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06308575 id: 2023-0771 id: NCI-2024-02155 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: A Phase II Study of Rivoceranib for Patients With Recurrent or Metastatic Olfactory Neuroblastoma overallStatus: NOT_YET_RECRUITING date: 2024-09-30 date: 2026-11-30 date: 2028-11-30 date: 2024-03-13 date: 2024-03-13 name: M.D. Anderson Cancer Center class: OTHER name: Elevar Therapeutics briefSummary: To learn if rivoceranib can help to control olfactory neuroblastoma. The safety of this drug in participants with olfactory neuroblastoma will also be studied. conditions: Metastatic Olfactory Neuroblastoma conditions: Recurrent Olfactory Neuroblastoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: Rivoceranib measure: Safety and Adverse Events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Luana Guimaraes De Sousa, MD role: CONTACT phone: 832-728-7849 email: lgsousa@mdanderson.org name: Luana Guimaraes De Sousa, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06308562 id: 23-010717 briefTitle: Fuzzy Wale Compression Stockinet to Promote Healing Following Transtibial Amputation for Peripheral Arterial Disease overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-08 date: 2024-08 date: 2024-03-13 date: 2024-04-04 name: Mayo Clinic class: OTHER briefSummary: The objective of this study is to determine if using Fuzzy Wale compression stockinett can assist in reducing the healing time and decrease costs in trastibial amputation patients as compared to standard of care treatment compression stocking. conditions: Peripheral Arterial Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: Fuzzy Wale Compression Stockinet measure: Surgical site infection measure: Wound dehiscence measure: Days on negative pressure wound therapy measure: Pain control measure: Time to prosthetic fitting measure: Length of hospital stay sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States name: Vascular Research Team role: CONTACT phone: 507-538-7425 name: Matthew Melin, M.D. role: CONTACT phone: (507) 266-6717 email: Melin.Matthew@mayo.edu name: Matthew Melin, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06308549 id: 2023.0714 briefTitle: MyDiaMate For Remission Of Diabetes Distress In Type 1 Diabetes (MyREMEDY) acronym: MyREMEDY overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-07 date: 2025-07 date: 2024-03-13 date: 2024-03-13 name: Maartje de Wit class: OTHER name: Juvenile Diabetes Research Foundation name: King's College London name: University of Malaga name: Forschungsinstitut der Diabetes Akademie Mergentheim briefSummary: In the MyREMEDY study the investigators research whether the MyDiaMate self-help application is effective in strengthening the mental health of adults with type 1 diabetes in comparison with care as usual. The MyREMEDY study takes place in four countries: The Netherlands, United Kingdom, Spain, and Germany. conditions: Type 1 Diabetes conditions: Diabetes Distress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 660 type: ESTIMATED name: MyDiaMate measure: Diabetes Distress measure: Emotional well-being measure: Psychological self-efficacy in relation to diabetes measure: Social Engagement measure: Fatigue measure: HbA1c measure: Time in/above/below range measure: Events of ketoacidosis/severe hypoglycaemia measure: MyDiaMate usage data sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Forschungsinstitut Diabetes-Akademie Bad Mergentheim city: Bad Mergentheim state: Baden-Württemberg zip: 97980 country: Germany name: Dominic Ehrmann role: CONTACT phone: +4979319613839 email: info@fidam.de name: Dominc Ehrmann role: PRINCIPAL_INVESTIGATOR name: Gina Lehmann role: SUB_INVESTIGATOR name: Norbert Hermanns role: PRINCIPAL_INVESTIGATOR lat: 49.4925 lon: 9.77361 facility: Amsterdam UMC city: Amsterdam state: Noord-Holland zip: 1081HV country: Netherlands name: Theresa Mohr, MSc role: CONTACT phone: +31205669111 email: myremedy@amsterdamumc.nl name: Maartje de Wit, Dr. role: PRINCIPAL_INVESTIGATOR name: Theresa Mohr, MSc. role: SUB_INVESTIGATOR lat: 52.37403 lon: 4.88969 facility: Universidad de Málaga city: Málaga zip: 29071 country: Spain name: Maria Teresa Anarte role: CONTACT phone: +34952131313 email: info@uma.es name: Maria Teresa Anarte role: PRINCIPAL_INVESTIGATOR lat: 36.72016 lon: -4.42034 facility: King's College London city: London zip: WC2R 2LS country: United Kingdom name: Kirsty Winkley, Dr. role: CONTACT phone: +4402078365454 email: MyREMEDY@kcl.ac.uk name: Kirsty Winkly, Dr. role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06308536 id: KY-2023-045 briefTitle: Application of Concentrated Growth Factors in Alveolar Ridge Preservation overallStatus: RECRUITING date: 2023-05-09 date: 2024-10-01 date: 2025-04-01 date: 2024-03-13 date: 2024-03-13 name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: To explore the role of CGF in the regeneration or preservation of soft and hard tissues during tooth extraction site preservation surgery. conditions: Alveolar Ridge Preservation conditions: Concentrated Growth Factor studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: bone powder + collagen membrane name: bone powder + collagen membrane + CGF membrane name: bone powder mixed wih CGF gel + collagen membrane + CGF membrane name: bone powder + CGF membrane measure: the width of keratinized gingiva measure: the horizontal width (from buccal to lingual at the alveolar top ) of gingiva measure: the horizontal bone resorption of alveolar crest measure: the vertical bone resorption of alveolar crest measure: the average gray value of alveolar bone measure: Landry wound healing index measure: reduction in membrane exposure area measure: pain score sex: ALL minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: The Fourth Affiliated Hospital Zhejiang University School of Medicine status: RECRUITING city: Yiwu state: Zhejiang Procince zip: 310000 country: China name: Genying Zhuang, Master role: CONTACT phone: 13758195143 email: 20918620@zju.edu.cn lat: 29.31506 lon: 120.07676 hasResults: False

 nctId: NCT06308523 id: AP303-PK-02 briefTitle: A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in Healthy Chinese Participants overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-06-10 date: 2024-06-30 date: 2024-03-13 date: 2024-03-13 name: Alebund Pharmaceuticals class: INDUSTRY briefSummary: The study will be a single center, double-blind, randomized, placebo-controlled, multiple-ascending-dose study to evaluate the safety, tolerability, PK and PD of AP303 following 2-week oral administration to healthy Chinese participants. conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 18 type: ESTIMATED name: AP303 150 μg name: Placebo 150 μg name: AP303 300 μg name: Placebo 300 μg measure: Cmax measure: Tmax measure: AUC0-24h measure: AUC0-last measure: AUC0-inf measure: AUC0-t measure: t1/2 measure: CL/F measure: V/F measure: Cav measure: Ctrough measure: Rac measure: Incidence and severity of adverse events measure: Incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation and urinalysis test results measure: Effect of AP303 on ECG parameters measure: Effect of AP303 on ECG parameters measure: Effect of AP303 on ECG parameters measure: Effect of AP303 on ECG parameters measure: Effect of AP303 on ECG parameters measure: Effect of AP303 on ECG parameters measure: Vital signs measure: Effect of AP303 on physical examination result measure: body weight measure: Fasting glucose measure: Fasting lipid profile measure: Serum creatinine measure: eGFR sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06308510 id: MEC-2024tba briefTitle: Detection of Aneuploidy in Cell Free DNA to Improve the Sensitivity of Diagnostic Peritoneal Lavage in Gastric Cancer overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-07 date: 2028-07 date: 2024-03-13 date: 2024-03-13 name: Erasmus Medical Center class: OTHER briefSummary: Aneuploidy may be used as a more sensitive diagnostic tool to detect peritoneal metastasis compared to conventional cytology and imaging techniques. Our aim is to establish whether aneuploidy as detected in cfDNA (as a measure for ctDNA) in PLF of patients with GC may hold value as an additional staging and tumor evaluation method in GC patients. conditions: Gastric Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 63 type: ESTIMATED name: collection additional peritoneal lavage fluid measure: Sensitivity mFast-SeqS measure: DFS measure: Concordance detection rates peritoneal dissemination sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus MC city: Rotterdam zip: 3015GD country: Netherlands name: Jessie Huizer, Drs role: CONTACT phone: +31107034523 email: t.j.huizer@erasmusmc.nl name: Niels Guchelaar role: CONTACT email: n.guchelaar@erasmusmc.nl lat: 51.9225 lon: 4.47917 hasResults: False

 nctId: NCT06308497 id: 2024-Q10PREGNANT briefTitle: Adjunctive Periodontal Treatment With Coenzyme Q10 in Association With Probiotics for Pregnant Women overallStatus: ENROLLING_BY_INVITATION date: 2024-03-10 date: 2024-10-15 date: 2024-10-20 date: 2024-03-13 date: 2024-04-26 name: University of Pavia class: OTHER briefSummary: The aim of the study is to assess if probiotic supplementation can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients. conditions: Periodontal Diseases conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-arm parallel design primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Products will be concealed. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Probiotic Treatment name: Standard Treatment measure: Change in Plaque Index measure: Change in Recession (R) measure: Change in Clinical Attachment Loss (CAL) measure: Change in Bleeding on Probing (BoP) measure: Change in Probing Pocket Depth (PPD) measure: Change in API - Approximal Plaque Index measure: Change in Plaque Control Record (PCR%) measure: Change in Papillary Marginal Gingival Index (PMGI) measure: Change in modified Marginal Gingival Index (mMGI) sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia city: Pavia state: Lombardy zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06308484 id: TRR265 C02 FP2 briefTitle: Neuromodulation and Mindfulness Patients With AUD overallStatus: RECRUITING date: 2024-03-20 date: 2027-06-30 date: 2027-06-30 date: 2024-03-13 date: 2024-03-13 name: Charite University, Berlin, Germany class: OTHER name: Medical School Berlin briefSummary: Our primary objective is to integrate tVNS and mindfulness meditation within a structured mindfulness-based relapse prevention (MBRP) program for detoxified alcohol-dependent patients (AD). We aim to determine whether neuromodulation can enhance mindfulness-based relapse prevention compared to mindfulness practice alone. In this context, we will investigate potential changes in the interaction of top-down control and cue reactivity, as well as assess the severity of AUD. Measurements of drinking behavior, cravings, and abstinence rates will be conducted up to three months post-treatment. Our second objective is to examine the causal role of frontal midline theta oscillations (FMΘ) in MBRP and cognitive control. To achieve this, we will first establish closed-loop amplitude-modulated transcranial alternating current stimulation (CLAM-tACS) to selectively modulate FMΘ oscillations during MBRP meditation exercises in AUD patients (2). conditions: Alcohol Dependence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 140 type: ESTIMATED name: Transcutaneous vagus nerve stimulation name: Closed-loop AM-tACS measure: Cognitive Control measure: Interoception measure: Cue-Reactivity measure: Heartrate measure: Heartrate Variability measure: Mindfulness measure: Alcohol consumption measure: Dependence Severity (Alcohol Dependence Scale) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité - Berlin University of Medicine status: RECRUITING city: Berlin zip: 10117 country: Germany name: Rosenthal role: CONTACT phone: 0049 30 450 517040 lat: 52.52437 lon: 13.41053 hasResults: False

 nctId: NCT06308471 id: ege üniversitesi briefTitle: Effect of Baby Massage on Oral Motor Skills of Premature Babies overallStatus: COMPLETED date: 2021-09-01 date: 2023-05-01 date: 2023-05-01 date: 2024-03-13 date: 2024-03-13 name: Ege University class: OTHER briefSummary: This experimental research was conducted in a single-blind, block randomized controlled design type.

The primary purpose of the study is to examine the effect of premature baby massage on oral motor coordination skills. The secondary aim is to evaluate the consistency of use of The Oral Feeding clinical scale in premature babies in Turkey.

As a result of the power analysis, baby massage was applied to the intervention group (n = 20) and oral stimulation with the Fucile protocol was applied to the control group (n = 20).

Comparative results were evaluated statistically. conditions: Infant, Premature studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Baby massage was applied to the intervention group (20) of the study, and oral stimulation was applied with the Fucile protocol to the control group (20). primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Professional nurses who evaluate nutrition do not know which group they belong to in the study.

They do not know which group the premature babies are in due to their age. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Baby massage was applied to the intervention group (n=20) of the study name: Oral stimulation measure: time for first oral feeding measure: time for full oral feeding measure: discharge time sex: ALL minimumAge: 1 Day maximumAge: 28 Days stdAges: CHILD facility: Ege University city: Izmir state: Bornova zip: 35040 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06308458 id: P.T.REC/012/003966 briefTitle: Breather Exerciser Trainer on Diaphragmatic Mobility And Thickness overallStatus: COMPLETED date: 2023-03-30 date: 2024-01-01 date: 2024-03-01 date: 2024-03-13 date: 2024-03-13 name: Adly A Adam class: OTHER briefSummary: The purpose of this study is to the effect of the breather exerciser trainer on diaphragmatic mobility and thickness in elderly. conditions: Aging Well studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective pre/ posttreatment, randomized controlled study primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double masking (Investigator, Outcomes assessor whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Breather Exerciser Trainer name: Conventional Breathing Exercise measure: Diaphragmatic thickness in millimeters measure: Diaphragmatic mobility in centimeters measure: Functional Capacity measure: Geriatric Quality of life Questionnaire measure: Geriatric Quality of Life sex: ALL minimumAge: 65 Years maximumAge: 75 Years stdAges: OLDER_ADULT facility: Faculty of Physical Therapy city: Giza country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06308445 id: RC31/23/0388 briefTitle: Safety Study for the Use of Rapamycin in Children With Familial Adenomatous Polyposis acronym: RAPA-4-PAF overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2029-08 date: 2029-08 date: 2024-03-13 date: 2024-03-13 name: University Hospital, Toulouse class: OTHER briefSummary: The hypothesize of this research is that rapamycin is effective and well-tolerated in teenagers with familial adenomatous polyposis (FAP). Rapamycin could be effective in blocking the formation of adenomas and/or their evolution by decreasing their size and number. Researchers aim to assess the safety profile of rapamycin in FAP adolescents using a 2 low dose regimen. conditions: Familial Adenomatous Polyposis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Rapamycin measure: Evaluation of the safety profile of two doses of rapamycin in adolescents with Familial Adenomatous Polyposis. measure: Evaluation of the effect of rapamycin on the number of polyps, on the entire colon and by segments (rectum, left colon, transverse colon and right colon) in adolescents suffering from Familial Adenomatous Polyposis measure: Evaluation of the effect of rapamycin on the size of polyps, on the entire colon and by segments (rectum, left colon, transverse colon and right colon) in adolescents suffering from Familial Adenomatous Polyposis. measure: Evaluation of the effect of rapamycin on the size of the largest polyp in each segment (rectum, left colon, transverse colon and right colon) in adolescents with Familial Adenomatous Polyposis sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: CHU Bordeaux Hôpital Pellegrin city: Bordeaux zip: 33076 country: France name: Raphael Enaud, Dr role: CONTACT phone: +33 5 56 79 98 24 email: raphael.enaud@chu-bordeaux.fr name: Raphaël ENAUD, MD role: PRINCIPAL_INVESTIGATOR lat: 44.84044 lon: -0.5805 facility: CHU Montpellier Hôpital Arnaud de Villeneuve city: Montpellier zip: 34295 country: France name: Laura Kollen, Dr role: CONTACT phone: +33 4 67 33 67 33 email: l-kollen@chu-montpellier.fr name: Laura KOLLEN, MD role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 facility: APHP Hôpital Robert Debré city: Paris zip: 75019 country: France name: Jérôme VIALA, Pr role: CONTACT phone: +33 1 40 03 36 83 email: jerome.viala@aphp.fr name: Jérôme VIALA role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: CHU Toulouse Hôpital des Enfants city: Toulouse zip: 31300 country: France name: Emmanuel Mas, Pr role: CONTACT phone: +33 5 34 55 84 45 email: mas.e@chu-toulouse.fr name: Emmanuel MAS, MD role: PRINCIPAL_INVESTIGATOR lat: 43.60426 lon: 1.44367 hasResults: False

 nctId: NCT06308432 id: UCAMCFE-00036 briefTitle: Sweat Rate Measurement With a Sensor (Wearable) in Different Climatic Conditions With Road Cyclists. acronym: CYSU overallStatus: RECRUITING date: 2024-02-19 date: 2024-04-12 date: 2024-05-20 date: 2024-03-13 date: 2024-03-13 name: Universidad Católica San Antonio de Murcia class: OTHER briefSummary: Controlled, double-blind, crossover clinical trial with six parallel arms depending on the combination of temperature and humidity (22º and 40% humidity, 35º 40% humidity and 35º and 65% humidity), with two differents intensity, to investigate and validate the physiological use of a sensor in recreational road cyclists. conditions: Sweat studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: SINGLE whoMasked: INVESTIGATOR count: 12 type: ESTIMATED name: Low intensity name: Low temperature name: Low Humidity name: High intensity name: High temperature name: High humidity measure: Sweat measure: Microcapillary Blood measure: Heart Rate measure: Fatigue measure: Temperature on the forehead measure: Temperature in the ear measure: Sleep efficiency measure: Karolinska drowsiness scale sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Catholic University of Murcia status: RECRUITING city: Murcia zip: 30107 country: Spain name: Fco Javier López Román role: CONTACT phone: 968278523 email: jlroman@ucam.edu lat: 37.98704 lon: -1.13004 hasResults: False

 nctId: NCT06308419 id: 2023-0900 id: NCI-2024-01751 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcomas With TSC2 or TSC1 Loss-of-function Mutations or Deletions overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2029-02-01 date: 2031-02-01 date: 2024-03-13 date: 2024-03-15 name: M.D. Anderson Cancer Center class: OTHER name: Aadi Bioscience briefSummary: To find a recommended dose of gemcitabine and nab-sirolimus that can be given in combination to participants with advanced leiomyosarcomas or soft-tissue sarcomas. conditions: Leiomyosarcoma conditions: Soft-tissue Sarcomas studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Gemcitabine name: Nab-Sirolimus measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Elise Nassif, MD role: CONTACT phone: 281-460-0607 email: efnassif@mdanderson.org name: Gracy Zacharian, BSN,MSN,RN role: CONTACT phone: (713) 792-2669 email: gzachari@mdanderson.org name: Elise Nassif, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06308406 id: HRS-1167-201-Bev briefTitle: A Phase Ib/II Clinical Study of HRS-1167 in Combination With Bevacizumab in Patients With Recurrent Ovarian Cancer overallStatus: RECRUITING date: 2024-03-15 date: 2025-10 date: 2025-10 date: 2024-03-13 date: 2024-04-11 name: Jiangsu HengRui Medicine Co., Ltd. class: INDUSTRY briefSummary: This study is a multicenter, open-label Phase Ib/II clinical trial to observe and evaluate the safety, tolerability and pharmacokinetics of HRS-1167 in combination with bevacizumab in patients with recurrent ovarian cancer mechanical characterization and preliminary evaluation of the efficacy of HRS-1167 in combination with bevacizumab in patients with recurrent ovarian cancer. conditions: Recurrent Ovarian Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: Bevacizumab； HRS-1167 measure: The number of subjects with dose-limiting toxicity (DLT) measure: Determination of Recommended Phase II dose (RP2D) measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Duration of Response (DoR) measure: Progression free Survival (PFS) measure: Overall Survival (OS) measure: Time To Response(TTR) sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital of University of Science and Technology of China status: NOT_YET_RECRUITING city: Hefei state: Anhui zip: 230002 country: China name: Ying Zhou role: PRINCIPAL_INVESTIGATOR lat: 31.86389 lon: 117.28083 facility: Cancer Hospital Chinese Academy of Medical Sciences status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100021 country: China name: Lingying Wu role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Beijing Cancer Hospital status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100142 country: China name: Hong Zheng role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Chongqing University Cancer Hospital status: NOT_YET_RECRUITING city: Chongqing state: Chongqing zip: 400000 country: China name: Yu Huang role: PRINCIPAL_INVESTIGATOR lat: 29.56278 lon: 106.55278 facility: The First Affiliated Hospital of Chongqing Medical University status: NOT_YET_RECRUITING city: Chongqing state: Chongqing zip: 400016 country: China name: Junying Tang role: PRINCIPAL_INVESTIGATOR lat: 29.56278 lon: 106.55278 facility: Guangxi Medical University Affiliated Tumor Hospital status: NOT_YET_RECRUITING city: Nanning state: Guangxi zip: 530022 country: China name: He Wang role: PRINCIPAL_INVESTIGATOR lat: 22.81667 lon: 108.31667 facility: The Fourth Hospital of Hebei Medical University status: NOT_YET_RECRUITING city: Shijiazhuang state: Hebei zip: 050001 country: China name: Hui Zhang role: PRINCIPAL_INVESTIGATOR lat: 38.04139 lon: 114.47861 facility: Harbin Medical University Cancer Hospital status: NOT_YET_RECRUITING city: Harbin state: Heilongjiang zip: 150001 country: China name: Ge Lou role: PRINCIPAL_INVESTIGATOR lat: 45.75 lon: 126.65 facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology status: NOT_YET_RECRUITING city: Wuhan state: Hubei zip: 430030 country: China name: Qinglei Gao role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 facility: Hunan Cancer Hospital status: RECRUITING city: Changsha state: Hunan zip: 410013 country: China name: Jing Wang role: PRINCIPAL_INVESTIGATOR lat: 28.19874 lon: 112.97087 facility: Liaoning Cancer Hospital status: NOT_YET_RECRUITING city: Shenyang state: Liaoning zip: 110042 country: China name: Danbo Wang role: PRINCIPAL_INVESTIGATOR lat: 41.79222 lon: 123.43278 facility: Qilu Hospital of Shandong University status: NOT_YET_RECRUITING city: Jinan state: Shandong zip: 250000 country: China name: Hualei Bu role: PRINCIPAL_INVESTIGATOR lat: 36.66833 lon: 116.99722 facility: Shandong First Medical University Affiliated Cancer Hospital status: NOT_YET_RECRUITING city: Jinan state: Shangdong zip: 250117 country: China name: Liang Chen role: PRINCIPAL_INVESTIGATOR lat: 36.66833 lon: 116.99722 facility: Shanxi Provincial Cancer Hospital status: NOT_YET_RECRUITING city: Taiyuan state: Shanxi zip: 030006 country: China name: Hongwei Zhao role: PRINCIPAL_INVESTIGATOR lat: 37.86944 lon: 112.56028 facility: Sichuan Cancer Hospital status: NOT_YET_RECRUITING city: Chengdu state: Sichuan zip: 610042 country: China name: Guonan Zhang role: PRINCIPAL_INVESTIGATOR lat: 30.66667 lon: 104.06667 facility: Tianjin Cancer Hospital status: NOT_YET_RECRUITING city: Tianjin state: Tianjin zip: 300000 country: China name: Ke Wang role: PRINCIPAL_INVESTIGATOR lat: 39.14222 lon: 117.17667 facility: Yunnan Cancer Hospital status: NOT_YET_RECRUITING city: Kunming state: Yunnan zip: 650118 country: China name: Hongying Yang role: PRINCIPAL_INVESTIGATOR lat: 25.03889 lon: 102.71833 facility: Zhejiang Cancer Hospital status: NOT_YET_RECRUITING city: Hangzhou state: Zhejiang zip: 310005 country: China name: Tao Zhu role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06308393 id: RSP61418 briefTitle: Randomized, Double-blind, Placebo-controlled Study of RSS0393 Ointment in Healthy and Psoriatic Subjects overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-08 date: 2024-10 date: 2024-03-13 date: 2024-03-13 name: Jiangsu HengRui Medicine Co., Ltd. class: INDUSTRY briefSummary: Randomized, double-blind, placebo-controlled study of RSS0393 ointment in healthy and psoriatic subjects conditions: Healthy conditions: Psoriatic Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 88 type: ESTIMATED name: RSS0393 ointment；Placebo measure: The percent of Local skin tolerance was assessed as moderate or higher（Single dose in healthy subjects） measure: The percent of Local skin tolerance was assessed as moderate or higher （Multiple dose in healthy subjects） measure: Measurement of blood examination（Multiple dose in patients ） measure: Measurement of urine examination（Multiple dose in patients ） measure: Measurement of Blood Chemistry examination（Multiple dose in patients ） measure: Measurement of coagulation function examination（Multiple dose in patients ） measure: AUC0-t （Single dose in healthy subjects） measure: AUC0-∞（Single dose in healthy subjects） measure: Tmax（Single dose in healthy subjects） measure: Cmax（Single dose in healthy subjects） measure: t1/2（Single dose in healthy subjects） measure: CL/F（Single dose in healthy subjects） measure: Vz/F（Single dose in healthy subjects） measure: AUC0-t （Multiple dose in healthy subjects） measure: AUC0-∞（Multiple dose in healthy subjects） measure: Tmax（Multiple dose in healthy subjects） measure: Cmax（Multiple dose in healthy subjects） measure: t1/2（Multiple dose in healthy subjects） measure: CL/F（Multiple dose in healthy subjects） measure: Vz/F（Multiple dose in healthy subjects） measure: Absolute change in PASI score relative to baseline（Multiple dose in patients ） measure: The percentage change in PASI score relative to baseline（（Multiple dose in patients ） measure: The percentage of PASI50、PASI75、PASI90、PASI100（Multiple dose in patients ） measure: The percentage of subjects' achieving PGA score of 0 or 1 and which improvement ≥ 2 from baseline （Multiple dose in patients ） measure: The percentage of subjects' inPGA score improvement ≥ 2 from baseline（Multiple dose in patients ） measure: Absolute change in BSA score relative to baseline（Multiple dose in patients ） measure: The percentage change in BSA score relative to baseline（Multiple dose in patients ） measure: Pharmacokinetics (PK) : Concentrations of RSS0393（Multiple dose in patients ） measure: Pharmacokinetics (PK) : The major metabolites of RSS0393（Multiple dose in patients ） sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06308380 id: UCV/2022-2023/158 briefTitle: Effectiveness of Rehabilitation Protocol in Patients With Shortened Posterior Leg Muscles acronym: EREPSOLM overallStatus: RECRUITING date: 2024-03-10 date: 2024-07-01 date: 2025-03-10 date: 2024-03-13 date: 2024-04-23 name: Fundación Universidad Católica de Valencia San Vicente Mártir class: OTHER briefSummary: The goal of this clinical study is to develop a specialized rehabilitation exercise protocol designed for patients diagnosed with foot pathologies and calf muscle shortening, regardless of their choice to undergo minimally invasive ultrasound-guided surgery. The primary focus is to assess disparities in outcomes, particularly in the recovery of ankle mobility degrees. Additionally, for patients opting for minimally invasive ultrasound-guided surgery, the study aims to evaluate the resumption of both sporting activities and daily routines using the aforementioned specific rehabilitation protocol.

The primary questions this study aims to answer are:

* How does the proposed rehabilitation protocol impact ankle mobility recovery for patients with foot pathologies and calf muscle shortening?
* What are the differences observed in the return to sporting activities and daily life among patients undergoing minimally invasive ultrasound-guided surgery, following the prescribed protocol?

Participants enrolled in this study will be engaged in:

Undertaking the specified rehabilitation exercises tailored for foot pathologies and calf muscle shortening.

Those opting for minimally invasive ultrasound-guided surgery will follow the same rehabilitation protocol post-surgery to assess its impact on their return to normal activities.

If there exists a comparison group:

Researchers will compare participants who undergo minimally invasive ultrasound-guided surgery against those who choose other treatment options to discern any differential effects on ankle mobility recovery and resumption of activities. conditions: Equinus Deformity of Foot conditions: Gastrocnemius Equinus conditions: Contracture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Specific protocol of rehabilitation exercise name: Short gastrocnemius surgery. measure: Gait Analysis measure: Baropodometric examination measure: Passive ankle mobility measure: Short Form Health Survey 36 score measure: Foot Function Index measure: American Orthopedic Foot and Ankle Score measure: Halasi score measure: Olerud and Molander ankle score. measure: Visual Analogue Scale sex: ALL minimumAge: 20 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Podologia Avançada status: RECRUITING city: Granollers state: Barcelona zip: 08401 country: Spain name: Lluis Castillo-Sanchez, Dr role: CONTACT phone: 610143173 email: info@podologiaavanzadabcn.com name: Lluis Castillo, Dr role: SUB_INVESTIGATOR name: Cristina Razzano role: PRINCIPAL_INVESTIGATOR name: Simone Moroni role: SUB_INVESTIGATOR lat: 41.60797 lon: 2.28773 facility: Clinica Mayral foot center status: RECRUITING city: Barcelona state: Barcelon zip: 08029 country: Spain name: Jordi Mayral role: CONTACT phone: (+34) 93 339 78 41 email: barcelona@clinicamayral.com name: Jordi Mayral role: SUB_INVESTIGATOR name: Cristina Razzano role: PRINCIPAL_INVESTIGATOR name: Simone Moroni role: SUB_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Clinicas UCV status: RECRUITING city: Valencia state: València zip: 46001 country: Spain name: Pablo Vera-Ivars, Dr. role: CONTACT phone: 963 92 06 24 email: clinicas.ucv@ucv.es name: Cristina Mico-Salcedo role: CONTACT phone: 963 92 06 24 email: clinicas.ucv@ucv.es name: Javier Ferrer-Torregrosa, Dr role: PRINCIPAL_INVESTIGATOR name: Juan Vicente-Mampel, Dr. role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06308367 id: XWTEBS briefTitle: The Therapeutic Effect of Betaine in Syringomyelia overallStatus: RECRUITING date: 2024-03 date: 2027-03 date: 2028-03 date: 2024-03-13 date: 2024-03-13 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: Purpose: This clinical trial aims to evaluate the indications, therapeutic effects and side effects of betaine in refractory syringomyelia.

Primary outcome measure: The primary endpoint is the change of ASIA at week 12. The clinical efficacy is defined as ASIA increase ≥ 1 at week 12, as compared with that before betaine usage. conditions: Syringomyelia studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Betaine name: Placebo measure: ASIA Score measure: syringomyelia remission measure: Electrophysiology results measure: Visual Analog Scale (VAS) measure: Klekamp and Sammi syringomyelia scale measure: modified Japanese Orthopaedic Association Scores (mJOA) measure: xuanwu syringomyelia scale measure: Incidence of complications sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fengzeng Jian status: RECRUITING city: Beijing state: Beijing zip: 100053 country: China name: Yuan Chenghua role: CONTACT email: yuanchenghua@ccmu.edu.cn name: Jian Fengzeng role: CONTACT email: jianfengzeng@xwh.ccmu.edu.cn name: jian guan, dr role: SUB_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06308354 id: CRC dataset briefTitle: Colorectal Cancer Dataset in Xijing Hospital From 2011 overallStatus: RECRUITING date: 2011-01-01 date: 2048-01-01 date: 2048-01-01 date: 2024-03-13 date: 2024-03-13 name: Xijing Hospital class: OTHER briefSummary: To compare the differences of clinical pathological, treatment and prognosis in the guided subgroups in colorectal cancer, the investigator enrolled all the colorectal cancer patients who underwent surgery and were hospitalized in the Xijing hospital. conditions: Prognostic Cancer Model conditions: Chemotherapy conditions: Nutrition Related Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40000 type: ESTIMATED measure: overall survival measure: DFS sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fourth Military Medical University status: RECRUITING city: Xi'an state: Shaanxi country: China name: Jipeng Li role: CONTACT phone: +86-029-84771533 lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06308341 id: REC/RCR&AHS/23/0295 briefTitle: Combined Effects of Virtual Reality and Motor Imagery Techniques With Routine Physical Therapy in Post Stroke Patients overallStatus: RECRUITING date: 2024-02-25 date: 2024-05-19 date: 2024-05-28 date: 2024-03-13 date: 2024-03-13 name: Riphah International University class: OTHER briefSummary: Stroke a devastating neurological condition, causing severe neurological challenges such as balance issues, motor function and cognitive deficits among survivors and can cause disability and death. The use of Virtual Reality and Motor Imagery in rehabilitation of neurologic disorders is on the rise. In stroke patients, VR and MI combination has not been studied. This study aims to investigate the combined effects of Virtual Reality and Motor Imagery Techniques with Routine Physical Therapy in patients with post stroke patients. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: Virtual Reality technique + Motor Imagery technique + Routine Physical Therapy name: Virtual Reality + Routine Physical Therapy name: Motor Imagery +Routine Physical Therapy measure: Berg Balance Scale measure: Fugal-Meyer Scale measure: Barthel Index sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Riphah International University status: RECRUITING city: Lahore state: Punjab zip: 54660 country: Pakistan name: Muhammad Kashif, PhD-PT role: CONTACT phone: 03333125303 email: Kashif.shaffi@gmail.com lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06308328 id: NFEC-2024-090 briefTitle: A Real-world Observational Study of a Mucosal Contouring Method for Radiation-induced Oropharyngeal Mucositis overallStatus: RECRUITING date: 2024-04-01 date: 2026-11-30 date: 2027-01-31 date: 2024-03-13 date: 2024-03-13 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: The performance of the predictive models for the occurrence and severity of oropharyngeal mucositis established using either oral cavity contouring method or mucosa surface contouring method was unsatisfactory in nasopharyngeal carcinoma (NPC). Whereas the predictive model of a mucosal contouring method based on swallowing-induced breakthrough pain exhibited better overall performance in locally advanced NPC. Therefore, the investigators aimed to conduct a prospective, multicenter, real-world observational study to further assess the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC. conditions: Radiation-induced Oropharyngeal Mucositis conditions: Swallowing-induced Breakthrough Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 718 type: ESTIMATED measure: The AUC of the predictive model measure: The accuracy of the predictive model measure: The sensitivity of the predictive model measure: The specificity of the predictive model measure: The positive predictive value of the predictive model measure: The negative predictive value of the predictive model measure: The F1 score of the predictive model measure: The important predictors of severe oropharyngeal mucositis in the predictive model sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Cancer Hospital & Institute of Guangzhou Medical University status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong country: China name: Ronghui Zheng role: CONTACT lat: 23.11667 lon: 113.25 facility: Nanfang hospital, Southern medical university status: RECRUITING city: Guangzhou state: Guangdong country: China name: Jian Guan, Ph.D. role: CONTACT phone: 86+13632102247 email: guanjian5461@163.com lat: 23.11667 lon: 113.25 facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong country: China name: Yimin Liu role: CONTACT lat: 23.11667 lon: 113.25 facility: Sun Yat-sen University Cancer Center status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong country: China name: Linglong Tang role: CONTACT lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital, Sun Yat-sen University status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong country: China name: Yong Bao role: CONTACT lat: 23.11667 lon: 113.25 facility: Yuebei People's Hospital status: NOT_YET_RECRUITING city: Shaoguan state: Guangdong country: China name: Suming Pan role: CONTACT lat: 24.8 lon: 113.58333 facility: Peking University Shenzhen Hospital status: NOT_YET_RECRUITING city: Shenzhen state: Guangdong country: China name: Min Chen role: CONTACT lat: 22.54554 lon: 114.0683 facility: The Fifth Affiliated Hospital, Sun Yat-sen University status: NOT_YET_RECRUITING city: Zhuhai state: Guangdong country: China name: Siyang Wang role: CONTACT lat: 22.27694 lon: 113.56778 facility: Fudan University Shanghai Cancer Center status: NOT_YET_RECRUITING city: Shanghai state: Shanghai country: China name: Xueguan lv role: CONTACT lat: 31.22222 lon: 121.45806 facility: Sichuan Cancer Hospital status: NOT_YET_RECRUITING city: Chendu state: Sichuan country: China name: Wenjun Liao role: CONTACT hasResults: False

 nctId: NCT06308315 id: REC/RCR&AHS/23/0297 briefTitle: Effects of Rhythmic Balance Auditory Vision Training And Strength Training With Autism Spectrum Disorder. overallStatus: RECRUITING date: 2024-02-25 date: 2024-05-01 date: 2024-05-15 date: 2024-03-13 date: 2024-03-13 name: Riphah International University class: OTHER briefSummary: Autism, a complex neurodevelopmental disorder that is marked by limited interests, and challenges in communication and social interactions and problem includes difficulties in understanding and responding to social cues, repetitive behaviors, intense focus on specific interests, and challenges with verbal and nonverbal communication. Rhythmic Balance Auditory Vision Training (RBAVT) a therapeutic approach which helps in improving coordination and balance in individuals with various neurological conditions. Strength training enhance physical health and muscle development. Thus, the purpose of this study is to compare the effects of rhythmic balance auditory vision training and strength training on motor function and cognition in children with autism spectrum disorder. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient would be allocated. whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: Rhythmic balance visual auditory exercise + Routine physical therapy name: Strength Training + Routine Physical Therapy measure: Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) measure: Wisconsin Card Sorting Test (WCST) sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Riphah International University status: RECRUITING city: Lahore state: Punjab zip: 54660 country: Pakistan name: Muhammad Kashif, PhD-PT role: CONTACT phone: 03333125303 email: Kashif.shaffi@riphah.edu.pk lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06308302 id: REC/RCR&AHS/23/0355 briefTitle: Comparative Effects of IMT Vs EMT Along With AIT in COPD Patients overallStatus: COMPLETED date: 2023-05-23 date: 2024-01-30 date: 2024-02-15 date: 2024-03-13 date: 2024-03-13 name: Riphah International University class: OTHER briefSummary: Chronic Obstructive Pulmonary Disease (COPD) is the 3rd leading cause of mortality and 7th leading cause of ill-health worldwide. It is characterized by persistent and progressive air flow resistance with expiratory flow more compromised as compared to inspiratory flow leading to CO2 retention and prominent hyperinflation of lungs. The overall effects of COPD on the patient's entire body include pulmonary, followed by extra-pulmonary manifestations in which musculoskeletal derangements are more pronounced and interfere with daily activities, further deteriorating the patient's health. Restricted air flow leads to an increase in shortness of breath on slight exertion and early fatigue or exhaustion of respiratory muscles due to over work. Literature from the past describes how COPD care has advanced and emphasizes the value of pulmonary rehabilitation in addition to medicinal management to treat decadence. Many studies show that Inspiratory muscle training has positive effect on ABG's, some PFT's and diaphragmatic function. Endurance and strength training improve patient activity of daily living and dyspnea.

This study intricate the collation of Respiratory Muscle Training and Aerobic Interval Training on functional performance, exertional dyspnea and fatigue level in patients diagnosed with COPD. A randomized controlled trial will be integrated with the sample size of 53 patients which is calculated through epi-tool. Age of selected Patients will fall between 30-55 years and will be randomly assigned into 2 groups. Group A (Experimental group A) will get Inspiratory breather training along-with Aerobic Interval Training, Group B (Experimental group B) will get Expiratory muscle training along-with Aerobic Interval Training (Same Protocol). Data will be gathered from Pulmonology wards and OPD of selected hospital. Clinical Assessment will be incorporated through Karnofsky performance scale, Fatigue Severity Scale, MmRC Dyspnea scale, Digital Spirometer, and 6MWT. Pre-intervention assessment measures and Post-intervention measures will be noted and results will be compared. Study Duration will be of 06 months after approval of synopsis. Data analysis will be done through SPSS.

Key words: Aerobic Interval training (AIT), The Breather Device (BD), 6-min walk test (6MWT), Fatigue severity scale (FSS), Modified Medical Research Council dyspnea scale (mMRC), Chronic Obstructive Pulmonary Disease (COPD). conditions: COPD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 53 type: ACTUAL name: Group A (Inspiratory Muscles Training + Aerobic Interval Training) name: Group B (Expiratory Muscles Training +Aerobic Interval Training) measure: Modified Medical Research Council (mMRC) Dyspnea Scale measure: 6 Minute Walk Test measure: Karnofsky Performance Scale (KPS) measure: Fatigue Severity Scale (FSS) measure: FEV1 measure: FVC measure: FEV1/FVC sex: ALL minimumAge: 30 Years maximumAge: 55 Years stdAges: ADULT facility: Al-Zahra Rehabilitation Center, Gulab Devi Teaching Hospital city: Lahore state: Punjab zip: 42000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06308289 id: REC/RCR&AHS/23/0361 briefTitle: Combined Effects of Global Posture Re-education and Active Cycle of Breathing Technique in COPD overallStatus: RECRUITING date: 2024-03-03 date: 2024-06-05 date: 2024-06-15 date: 2024-03-13 date: 2024-03-13 name: Riphah International University class: OTHER briefSummary: The randomized controlled trial will involve 30 participants, with Group A receiving GPRM and ACBT, while Group B follows the conventional COPD model that includes ACBT only.Assessments of heart rate, physical fitness, and quality of life will contribute to a nuanced understanding of joint function, informing future COPD treatment paradigms. conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Global Posture Re-education name: Active Cycle of Breathing Technique measure: SF- 36 Questionnaire measure: FEV1/FVC ratio measure: 6-minute walk test measure: Photogrammetry measure: Forced expiratory volume (FEV1) measure: Forced vital capacity (FVC) sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Social Security Hospital status: RECRUITING city: Gujranwala state: Punjab zip: 52200 country: Pakistan name: Akhtar Hunjra, Phd role: CONTACT phone: 03041049249 email: ms.sshgw@pessi.punjab.gov.pk name: Komal Munir, DPT role: SUB_INVESTIGATOR lat: 32.15567 lon: 74.18705 hasResults: False

 nctId: NCT06308276 id: REC/RCR&AHS/23/0363 briefTitle: Effects of Aerobic Versus Resistance Training in Post Percutaneous Coronary Intervention Obese Patients overallStatus: RECRUITING date: 2024-03-01 date: 2024-06-05 date: 2024-06-15 date: 2024-03-13 date: 2024-03-13 name: Riphah International University class: OTHER briefSummary: The randomized clinical trial (RCT) endeavors to enroll 50 participants, divided equally into aerobic exercise and resistance exercise groups. The study employs rigorous tools such as blood pressure measurement, SF-36 questionnaire, and the Six-Minute Walk Test (6MWT) to assess VO2max. conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Clinical Trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Aerobic Training name: Resistance Training measure: Blood Pressure measure: Six Minute Walk Test measure: SF 36 Questionnaire sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: Sialkot Medical and Physiotherapy Center status: RECRUITING city: Sialkot state: Punjab zip: 51310 country: Pakistan name: Fasih Ahmed Rehmani, MS-OMPT role: CONTACT phone: 03348005240 email: Fasih12190@gmail.com name: Teenat Fatima, DPT role: SUB_INVESTIGATOR lat: 32.49268 lon: 74.53134 hasResults: False

 nctId: NCT06308263 id: MS201924_0003 id: 2022-502940-10-00 type: OTHER domain: EU trial number briefTitle: M1774 Human Mass Balance Study (DDRIVER Solid Tumors 303) overallStatus: RECRUITING date: 2024-03-25 date: 2025-11-26 date: 2025-11-26 date: 2024-03-13 date: 2024-04-26 name: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany class: INDUSTRY briefSummary: This is a single sequence 2-period open label study in participants with advanced solid tumors. The purpose of Period 1 of this study is to assess the mass balance to determine drug-related entities present in circulation and excreta and provide a comprehensive understanding of biotransformation pathways and clearance mechanisms in participants with advanced solid tumors. Thereafter, participants may enter an optional extension phase (Period 2) where participants will receive M1774 until disease progression or other criteria for study intervention discontinuation are met. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: M1774 [14C]M1774 microtracer name: M1774 measure: Period 1: Percent Urinary Recovery (feurine) Of Total Radioactivity (TRA) Over the Entire Period Of Collection measure: Period 1: Percent Fecal Recovery (fefeces) Of TRA Over the Entire Period Of Collection measure: Period 1: Percent Total Recovery in Urine and Feces (fetotal) Of TRA Over the Entire Period of Collection measure: Period 1: Maximum Observed Plasma Concentration (Cmax) Of M1774 measure: Period 1: Time to Reach Maximum Plasma Concentration (Tmax) Of M1774 measure: Period 1: Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) Of M1774 measure: Period 1: Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero Extrapolated to Infinity (AUC0-inf) Of M1774 measure: Period 1: Apparent Terminal Half-Life (t1/2) Of M1774 measure: Period 1: Apparent Total Body Clearance (CL/F) Of M1774 measure: Period 1: Apparent Volume of Distribution (Vz/F) Of M1774 measure: Period 1: Maximum Observed Concentration (Cmax) of TRA in Plasma and Whole Blood measure: Period 1: Time to Reach Maximum Concentration (tmax) of TRA in Plasma and Whole blood measure: Period 1: Area Under Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) of TRA in Plasma and Whole Blood measure: Period 1: Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of TRA in Plasma and Whole Blood measure: Period 1: Apparent Terminal Half-Life (t1/2) of TRA in Plasma and Whole Blood measure: Period 1,2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Treatment-Related AEs, Abnormal Laboratory Parameters, abnormal Vital Signs and abnormal 12-Lead Electrocardiogram (ECG) Findings sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pharmaceutical Research Associates Magyarország Kutatás - Fejlesztési Kft., Klinikai Farmakológiai Vizsgálóhely status: RECRUITING city: Budapest country: Hungary lat: 47.49801 lon: 19.03991 facility: Észak Pesti Centrum Kórház-Honvédkórház, Onkológiai Osztály status: NOT_YET_RECRUITING city: Budapest country: Hungary lat: 47.49801 lon: 19.03991 hasResults: False

 nctId: NCT06308250 id: REC/RCR&AHS/23/0294 briefTitle: Comparative Effects of Mime Therapy and Action Observation Therapy in Bell's Palsy overallStatus: RECRUITING date: 2024-02-25 date: 2024-05-01 date: 2024-05-15 date: 2024-03-13 date: 2024-03-13 name: Riphah International University class: OTHER briefSummary: The aim of this study is to determine comparative effects of mime therapy and action observation therapy on facial symmetry and quality of life in Bell's palsy. Bell's palsy is characterized as an abrupt paralysis of the peripheral facial nerve, typically without a known cause. Mime Therapy is a performing technique that helps patients regain the ability to use their face muscles. Action observation therapy is novel rehabilitation approach exploiting this mirror mechanism. conditions: Bell Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated. whoMasked: OUTCOMES_ASSESSOR count: 62 type: ESTIMATED name: MIME THERAPY name: ACTION OBSERVATION THERAPY measure: Sunny Brook Facial Grading System measure: Facial Disability Index sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Riphah International University status: RECRUITING city: Lahore state: Punjab zip: 54660 country: Pakistan name: Muhammad Kashif, PhD-PT role: CONTACT phone: 03333125303 email: kashif.shaffi@riphah.edu.pk lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06308237 id: REC/RCR&AHS/23/0293 briefTitle: Effects of Resisted Versus Balance Exercises on Cognitive And Motor Function In Patients With Mild Cognitive Impairment overallStatus: RECRUITING date: 2024-02-25 date: 2024-06-20 date: 2024-06-25 date: 2024-03-13 date: 2024-03-13 name: Riphah International University class: OTHER briefSummary: Mild cognitive impairment affects older adults and it includes memory and attentions deficits, and problem-solving difficulties in activities of daily living. Resisted exercises is considered a viable strategy to improve balance and motor function in older population. Balance exercises comprises proprioceptive, visual and motor learning to a larger degree and has positive effects on memory and spatial cognition and improves balance and motor function. This study aims to determine the effects of resisted and balance exercises on cognition and motor function in patients with mild cognitive impairment. conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated. whoMasked: OUTCOMES_ASSESSOR count: 66 type: ESTIMATED name: RESISTED EXERCISES name: BALANCE EXERCISES measure: MoCA (Montreal Cognitive Assessment ) measure: Mini-Balance Evaluation Systems Test (BESTest). measure: Timed UP and GO Test (TUG) : measure: Computerized battery test (CBT) sex: ALL minimumAge: 60 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Riphah International University status: RECRUITING city: Lahore state: Punjab zip: 54660 country: Pakistan name: Muhammad Kashif, PhD-PT role: CONTACT phone: 03333125303 email: kashif.shaffi@gmail.com lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06308224 id: REC/RCR&AHS/23/0290 briefTitle: Comparison of Modified-Otago and Tai Chi Exercises in Patients With Stroke overallStatus: RECRUITING date: 2024-02-25 date: 2024-05-01 date: 2024-05-24 date: 2024-03-13 date: 2024-03-13 name: Riphah International University class: OTHER briefSummary: The study aims to determine the comparative effects of Modified-Otago and Tai Chi Exercises on Balance and Motor Function in Patients with Stroke. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The study would be single-blinded as the assessor of the study would be kept blind of the treatment groups to which the patient would be allocated. whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: Modified-Otago Exercises name: Tai-Chi Exercises measure: Berg Balance Scale (BBS) measure: Timed Up and Go (TUG) measure: Motor Assessment Scale (MAS) sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Riphah International University status: RECRUITING city: Lahore state: Punjab zip: 54660 country: Pakistan name: Muhammad Kashif, PhD-PT role: CONTACT phone: 03333125303 name: Muhammad Kashif, PhD-PT role: CONTACT phone: 03333125303 email: kahif.shaffi@riphah.edu.pk lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06308211 id: REC/RCR&AHS/23/0289 briefTitle: Comparative Effects of Motor Imagery and Mirror Therapy Versus Motor Relearning Program in Subacute Stroke Patients overallStatus: RECRUITING date: 2024-02-25 date: 2024-05-01 date: 2024-05-15 date: 2024-03-13 date: 2024-03-13 name: Riphah International University class: OTHER briefSummary: Use of motor imagery, mirror therapy and motor relearning program in rehabilitation of people with stroke is on rise and these are unique and emerging techniques. Motor imagery is a mental rehearsal through visualization while mirror therapy creates a reflection of non-effected limb by using a mirror. Moreover, motor relearning is task-oriented approach, benefacial for balance and motor funCtion in patients with stroke that emphasizes on relearning.The aim of the study is to determine the comparative effects of motor imagery and mirror therapy versus motor relearning program in addition to routine physical therapy on balance, motor function and activities of daily living in subacute stroke patients. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient would be allocated. whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: MOTOR IMAGERY+MIRROR THERAPY+ROUTINE PHYSICAL THERAPY name: MOTOR RELEARNING PROGRAM+ROUTINE PHYSICAL THERAPY measure: Berg balance scale (BBS) measure: FUGL-MEYER ASSESMENT (FMA) measure: FUNCTIONAL INDEPENDENCE MEASURE (FIM) sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Muhammad Kashif status: RECRUITING city: Lahore state: Punjab zip: 54660 country: Pakistan name: Muhammad Kashif, Phd role: CONTACT phone: 03333125303 email: kashif.shaffi@gmail.com lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06308198 id: M24-008 briefTitle: A Study to Evaluate AGN-151586 Intramuscular Injections in Adult Participants for Treatment of Glabellar Lines overallStatus: RECRUITING date: 2024-03-29 date: 2025-03-22 date: 2025-03-22 date: 2024-03-13 date: 2024-04-29 name: AbbVie class: INDUSTRY briefSummary: Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate the safety and efficacy of AGN-151586 compared to placebo in adult participants.

AGN-151586 is an investigational product being developed for the treatment of GL. In the first period, participants are randomly assigned to receive AGN-151586 or placebo. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. In the second period, all participants who meet retreatment criteria will receive open-label AGN-151586. Around 160 participants will be enrolled in the study at approximately 14 sites in China, Taiwan, and Japan.

Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Eligible participants may then receive AGN-151586 injections on Day 43 and will be followed for up to 6 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care due to multiple study visits. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. conditions: Glabellar Lines studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 160 type: ESTIMATED name: AGN-151586 name: Placebo measure: Percentage of Participants with a >= 2-Grade Improvement from Baseline on the Facial Wrinkle Scale with Asian (FWS-A) Guide According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown measure: Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Participant Assessment of GL Severity at Maximum Frown measure: Number of Participants with Adverse Events (AEs) measure: Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Participant Assessment of GL Severity at Maximum Frown measure: Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Investigator Assessment of GL Severity at Maximum Frown measure: Percentage of Participants Achieving Mostly satisfied or Very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-Up Version Item 5 (overall satisfaction) for GL measure: Percentage of Participants Achieving Mostly satisfied or Very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-Up Version Item 4 (natural look) for GL measure: Percentage of Participants Achieving Mostly satisfied or Very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-Up Version Item 5 (overall satisfaction) for GL Over Time measure: Double-Blind Period: Time to the First >= 1-Grade Improvement from Baseline on the FWS-A According to Participant Assessment of GL Severity at Maximum Frown measure: Double-Blind Period: Time to the First >= 1-Grade Improvement from Baseline on the FWS-A According to Investigator Assessment of GL Severity at Maximum Frown measure: Double-Blind Period: Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Participant Assessment of GL Severity at Maximum Frown Over Time measure: Double-Blind Period: Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Investigator Assessment of GL Severity at Maximum Frown Over Time measure: Double-Blind Period: Time to Loss of None or Mild FWS-A According to Participant Assessment of FWS-A at Maximum Frown measure: Double-Blind Period: Time to Loss of None or Mild FWS-A According to Investigator Assessment of FWS-A at Maximum Frown measure: Percentage of Participants Achieving None or Mild on the FWS-A According to Participant Assessment Using FWS-A at Maximum Frown Over Time measure: Percentage of Participants Achieving None or Mild on the FWS-A According to Investigator Assessment Using FWS-A at Maximum Frown Over Time measure: Percentage of Participants with a >= 1-Grade Improvement from Baseline on FWS-A According to Participant Assessment of GL Severity at Maximum Frown measure: Percentage of Participants with a >= 1-Grade Improvement from Baseline on FWS-A According to Investigator Assessment of GL Severity at Maximum Frown measure: Percentage of Participants with a >= 20-Point Improvement from Baseline in 11-Item Facial Line Outcomes (FLO-11) Total Scores (transformed) for GL measure: Percentage of Participants with a >= 4-Point Improvement from Baseline in 11-Item FLO-11 Item 10 (look angry) for GL measure: Percentage of Participants with a >= 4-Point Improvement from Baseline in 11-Item FLO-11 Item 5 (look less attractive) for GL measure: Percentage of Partcipatns who Achieve Patient-Reported Global Assessment of Change in GL Based on the Global Assessment of Change in Glabellar Lines (GAC-GL) Over Time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Hospital /ID# 256084 status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China lat: 39.9075 lon: 116.39723 facility: Dermatology Hospital of Southern Medical University /ID# 256172 status: RECRUITING city: Guangzhou state: Guangdong zip: 510091 country: China lat: 23.11667 lon: 113.25 facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 255871 status: RECRUITING city: Wuhan state: Hubei zip: 430022 country: China lat: 30.58333 lon: 114.26667 facility: Zhongda Hospital Southeast University /ID# 255937 status: RECRUITING city: Nanjing state: Jiangsu zip: 210009 country: China lat: 32.06167 lon: 118.77778 facility: Xianyang Hospital of Yan'an University /ID# 256774 status: RECRUITING city: Xianyang state: Shaanxi zip: 712000 country: China lat: 34.33778 lon: 108.70261 facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 260669 status: RECRUITING city: Kaohsiung zip: 807 country: Taiwan lat: 22.61626 lon: 120.31333 hasResults: False

 nctId: NCT06308185 id: EPINEO briefTitle: Neonatal Seizures: Semiology, Etiology, Therapy and Prognosis Correlations overallStatus: ACTIVE_NOT_RECRUITING date: 2021-06-01 date: 2023-12-31 date: 2024-07-01 date: 2024-03-13 date: 2024-03-13 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: Epileptic seizures in newborns (often called "neonatal convulsions") represent the most frequent neurological problem in newborns (1-3/1000 newborns). The type of seizure and their etiology is very varied and therefore the therapeutic protocol also requires adaptations with a personalization of the therapeutic approach according to the characteristics of the case according to principles of precision medicine in particular for forms of neonatal epilepsy compared to epileptic seizures acute symptomatic. In recent years it has been highlighted that the clinical characterization and instrumental characterization, in particular electroencephalographic, of epileptic seizures represents an important biomarker that allows the choice of therapy to be oriented appropriately. In the literature there is a lack of single-center studies that relate the type of crisis according to the new ILAE 2017 classification (Fisher 2017) and its proposal for neonatal adaptation (Pressler 2021) with the etiology, type of therapy and outcome neurological after a few years.

The primary aim of the study is to evaluate the correlation between the type of seizure determined according to the ILAE classification (clinical variables), the EEG findings of the epileptic seizures and the specific etiology of the epileptic seizures.

The secondary aim is to evaluate the correlation between seizure type and etiology with effective therapy, length of hospitalization and neurobehavioral development outcome. The study design is a retrospective observational on the population of neonates managed at our center in the last decade. conditions: Neonatal Seizure conditions: Epilepsy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 140 type: ACTUAL name: observational study measure: Seizure Type and etiology correlation measure: EEG and etiology correlation measure: Etiology and and effective drug correlation measure: Etiology and neurobehavioral outcome correlation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico city: Milan zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06308172 id: CSI/2021 briefTitle: Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial overallStatus: RECRUITING date: 2021-12-01 date: 2024-12-01 date: 2026-12-01 date: 2024-03-13 date: 2024-03-13 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: The objective of this randomized monocentric study is to assess potential variations in the incidence and severity of isthmocele morbidity among women undergoing cesarean section with either single or double-layer closure of the hysterotomy. Our primary outcome aims to investigate whether there is a reduction in the median duration of intermenstrual spotting in patients belonging to the two respective closure groups conditions: Cesarean Section; Dehiscence conditions: Uterine Bleeding conditions: Uterus; Scar conditions: Uterus Abnormal conditions: Cesarean Section Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE maskingDescription: Patients are recruited and randomly assigned to either the "single-layer" or "double-layer" arm of the study. The randomization process occurs on the day of the cesarean section. Following randomization, patients are informed about their assigned group, and the cesarean section procedure is then carried out. count: 150 type: ESTIMATED name: Hysterotomy closure measure: Intermenstrual bleeding reduction (days) measure: Intra-operatory time measure: Blood loss measure: Analgesics measure: Post-operatory recovery time measure: Time to full patient mobilization measure: Isthmocele sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Cà Granda IRCCS Ospedale Maggiore Policlinico di Milano status: RECRUITING city: Milan state: Mi zip: 20122 country: Italy name: Giuseppe Perugino, MD role: CONTACT phone: 3383030553 email: giuseppe.perugino@policlinico.mi.it name: Floriana Carbone, MD role: SUB_INVESTIGATOR name: Ottavio Cassardo, MD role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06308159 id: LT02-101 briefTitle: An Open-label Study of a Gene Therapy Product in Beta-Thalassemia overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-04-01 date: 2027-04-01 date: 2024-03-13 date: 2024-03-13 name: Lantu Biopharma class: INDUSTRY briefSummary: This is an interventional study to evaluate the safety and efficacy of autologous Hematopoietic Stem Cells (HSCs) transduced with lentiviral vector encoding functional hemoglobin subunit beta (HBB) gene in patients with transfusion-dependent beta-thalassemia. conditions: Beta-Thalassemia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 3 type: ESTIMATED name: Vebeglogene autotemcel measure: Time and duration of the subject's hemoglobin (Hb)≥9.0 g/dL without receiving red blood cell infusion measure: The prevalence and severity of adverse events (AEs) and serious adverse events (SAEs) measure: The reduction of red blood cells (RBCs) transfusion requirement after product infusion compared to previous transfusion records measure: Number of days required to achieve successful neutrophil and platelet engraftment measure: Vector copy number (VCN) in peripheral blood over time sex: ALL minimumAge: 12 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06308146 id: S21-1249496 briefTitle: Effect of Bacillus Subtilis ATCC 122264 Supplementation on Gas Symptoms and Quality of Life in Participants With Functional Bloating overallStatus: COMPLETED date: 2022-04-21 date: 2022-10-11 date: 2022-10-11 date: 2024-03-13 date: 2024-03-15 name: Kerry Group P.L.C class: INDUSTRY name: Nutrasource Pharmaceutical and Nutraceutical Services, Inc. briefSummary: A randomized, double blind, placebo-controlled, 2-arm parallel study to evaluate the efficacy of Bacillus subtillis in providing relief and improving quality of life in participants suffering from functional abdominal bloating/distension when administered for a period of 8 weeks. conditions: Functional Bloating studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned in a 1:1 ratio to receive either the probiotic or placebo. Study products (i.e., TP and placebo) will be dispensed by the site as per the randomization scheme at the study visits. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: To minimize bias, the sponsor representatives involved in the study, the investigator, the participants, and any healthcare professionals or site personnel involved in participant management or outcome assessment remained blinded to interventional assignments whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ACTUAL name: Bacillus subtilis ATCC 122264 name: Placebo measure: Effect on intestinal gas symptoms and quality of life measure: Effect on intestinal gas symptoms and quality of life sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Apex Trials city: Guelph state: Ontario zip: N1G 0B4 country: Canada lat: 43.54594 lon: -80.25599 hasResults: False

 nctId: NCT06308133 id: CD34+CE_2023 briefTitle: Biological Variables Affecting CD34+ Peripheral Cells Collection Efficiency acronym: CD34+CE_2023 overallStatus: COMPLETED date: 2023-09-01 date: 2023-12-01 date: 2023-12-31 date: 2024-03-13 date: 2024-03-13 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: All procedures performed during the study will comply with current clinical practice, international and national guidelines. Main object of the study is the PBSC apheresis procedure performed by using the continuous mononuclear cells collection (cMNC) system with Spectra Optia (Terumo BCT), specifically the biological and clinical factors affecting the procedure efficiency. conditions: Optimize PBSC Harvest Through Automated Buffy Coat studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 113 type: ACTUAL name: apheresis procedure measure: measured by statistical correlation measure: Correlation of clinical sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica city: Milan state: Milano zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-07-10 uploadDate: 2024-03-06T12:44 filename: Prot_SAP_000.pdf size: 378344 hasResults: False

 nctId: NCT06308120 id: ISI-IONCN-002 briefTitle: A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB acronym: ARTICULAtE overallStatus: RECRUITING date: 2024-03-20 date: 2026-06-30 date: 2026-09-30 date: 2024-03-13 date: 2024-04-03 name: Intuitive Surgical class: INDUSTRY name: Intuitive Surgical-Fosun Medical Technology (Shanghai) Co., Ltd briefSummary: Multi-center randomized controlled study designed to compare the diagnostic yield of ION™ Endoluminal System with electromagnetic navigation bronchoscopy in patients undergoing transbronchial sampling procedure of peripheral pulmonary nodules. conditions: Pulmonary Nodule, Solitary conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Stratified, randomized controlled trial with parallel group assignment primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: Pathologist reviewing biopsy results will be blinded whoMasked: OUTCOMES_ASSESSOR count: 354 type: ESTIMATED name: Ion Endoluminal System name: superDimension Navigation System and Accessories measure: Diagnostic Yield measure: Sensitivity for malignancy of biopsy obtained samples measure: Incidence of pneumothorax that requires chest tube placement and/or re-hospitalization or extended hospitalization measure: Incidence of intraoperative severe airway bleeding sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital status: RECRUITING city: Shanghai state: Shanghai country: China name: Jiyuan Sun, M.D. role: CONTACT name: Jiyuan Sun, M.D. role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: Zhongshan Hospital status: NOT_YET_RECRUITING city: Shanghai state: Shanghai country: China name: Yuanlin Song, M.D. role: CONTACT name: Yuanlin Song, M.D. role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: West China Hospital status: NOT_YET_RECRUITING city: Chengdu state: Sichuan country: China name: Dan Liu role: CONTACT name: Dan Liu, M.D. role: PRINCIPAL_INVESTIGATOR lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06308107 id: IRB00433127 briefTitle: Safety and Feasibility of Hyperkalemic Cardioplegia With Diazoxide in Cardiac Surgery (CPG-DZX) Trial overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-30 date: 2028-04-30 date: 2024-03-13 date: 2024-03-13 name: Johns Hopkins University class: OTHER briefSummary: This study aims to confirm the safety and efficacy of diazoxide as an additive to hyperkalemic cardioplegia in patients undergoing cardiac surgery with cardiopulmonary bypass. The investigators hypothesize that diazoxide combined with hyperkalemic cardioplegia provides superior myocardial protection and reduced myocardial stunning compared with standard cardioplegia alone. Thirty patients will receive treatment. Safety will be assessed by comparing mean arterial blood pressure measurements, glucose levels and incidence of adverse events between the two groups. Efficacy will be assessed by comparing right and left ventricular function in pre-operative vs post-operative transesophageal echocardiograms, need for mechanical circulatory support, ease of separation from bypass and Vasoactive Inotrope Score (VIS) between the two groups. The information gained could pave the way for the use of Katp (Potassium-atp) channel openers to prevent stunning, improve patient outcomes, and reduce health care costs related to myocardial stunning that requires inotropic and mechanical support following cardiac surgery. conditions: Myocardial Stunning studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 30 type: ESTIMATED name: IV Diazoxide measure: Safety as assessed by mean change in blood pressure measure: Safety as assessed by change in blood glucose levels measure: Safety as assessed by incidence of adverse events measure: Efficacy as assessed by change in ejection fraction measure: Efficacy as assessed by use of mechanical circulatory support measure: Efficacy as assessed by change in Vasoactive Inotropic Score (VIS) measure: Efficacy as assessed by time to separate from Cardiopulmonary Bypass (CPB) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins Hospital city: Baltimore state: Maryland zip: 21287 country: United States lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06308094 id: IRB00429859 briefTitle: 320-detector Computed Tomography to Assess Myocardial Extracellular Volume Fraction in Patients With Atrial Fibrillation Before AF Ablation. overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-04-01 date: 2025-04-01 date: 2024-03-13 date: 2024-04-26 name: Johns Hopkins University class: OTHER briefSummary: This study explores the relationship between myocardial fibrosis and patient outcomes in Atrial Fibrillation (AF), specifically after catheter ablation. It aims to use Cardiac CT, an accessible tool, to measure left ventricular extracellular volume (ECV) as an indicator of fibrosis. The study will assess if higher ECV levels correlate with increased risks of AF recurrence, hospitalization, and poor cardiac function recovery. Positive findings could make ECV a key factor in deciding AF treatment strategies. conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE maskingDescription: Two independent blinded trained readers will detect, interpret and quantify interstitial fibrosis using CT images, to ascertain intra- and inter-observer variability. The readers will determine the region of interest (ROI), myocardial and blood pool attenuation values in the pre-contrast and 5 minutes delayed acquisition. count: 100 type: ESTIMATED name: CT measure: Recurrence of Atrial Fibrillation measure: Occurrence of ER visits, hospitalizations for cardiovascular causes measure: Change in Ejection Fraction measure: Quality of Life as assessed by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06308081 id: UPCC 13023 id: 849052 type: OTHER domain: University of Pennsylvania briefTitle: Social Media Anti-Vaping Messages to Reduce ENDS Use Among Sexual and Gender Minority Teens acronym: SMART overallStatus: RECRUITING date: 2024-02-21 date: 2025-05-31 date: 2025-12-31 date: 2024-03-13 date: 2024-04-12 name: Abramson Cancer Center at Penn Medicine class: OTHER name: University of Florida briefSummary: The investigators long-term goal is to reduce tobacco use and tobacco-related health disparities among SGM populations. The objective of Project SMART (Social Media Anti-Vaping Messages to Reduce ENDS Use Among Sexual and Gender Minority Teens) is to evaluate the effectiveness of an sexual gender minority (SGM) -tailored social media intervention to prevent vaping initiation among SGM youth ages 13-20 years. The investigators central hypothesis is that SGM-tailored anti-vaping social media messages will be more effective than existing non-tailored messages to prevent vaping initiation among SGM youth. The scientific premise for this work is based on principles of cultural tailoring in health communication for vulnerable populations, the Health Equity Promotion Model, and the Message Impact Framework. The investigators are developing and evaluating a social media intervention because SGM youth have a high rate of social media use and are more likely to go online for health information than non-SGM youth. Social media, moreover, are increasingly used for health promotion to address health disparities and well-being of SGM populations. The investigators will conduct rapid-cycle feedback with stakeholders including SGM organization leaders to provide input on the message design, testing, and intervention implementation to ensure feasibility and acceptability of the intervention. conditions: Vaping conditions: Adolescent Behavior conditions: Communication Research studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to 1 of 2 conditions: SGM-tailored anti-vaping messages versus non-tailored messages. Block randomization will achieve balance across the two conditions based on age group, gender identity, sexual orientation, race, ethnicity, and prior use. Both conditions will receive repeated exposure of messages within their assigned condition daily for 4, up to a total of 24 messages over the course of the study. Messages will be delivered using texting to participants mobile phones. We will record participants' self-reported engagement to the messages at the follow-up survey (after measuring the study outcomes). Participants will be asked to complete a baseline survey comprising vaping susceptibility and characteristics, surveys at 1-, 2-, 3-, and 4-weeks follow-up to measure vaping susceptibility. primaryPurpose: PREVENTION masking: NONE count: 1500 type: ESTIMATED name: Tailored measure: Susceptibility to vaping measure: Vaping initiation sex: ALL minimumAge: 13 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT facility: University of Pennsylvania status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Elaine Hanby, MA role: CONTACT phone: 215-573-5140 email: elaine.hanby@asc.upenn.edu name: Jenine Pilla, MPH role: CONTACT email: Jenine.Pilla@asc.upenn.edu name: Andy Tan, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06308068 id: BE24-002 briefTitle: Bioequivalence Study of Diacerein 50 mg Capsule in Healthy Thai Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-07-30 date: 2024-08-03 date: 2024-08-18 date: 2024-03-13 date: 2024-03-13 name: International Bio service class: NETWORK briefSummary: To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fed conditions conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Diacerein 50 mg Capsule measure: Bioequivalence based on Cmax period measure: Bioequivalence based on AUC parameters sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06308055 id: 2022-R01 briefTitle: Abiomed Impella RT-DAQ - Observational Study overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-03-13 date: 2024-03-13 name: Abiomed Inc. class: INDUSTRY briefSummary: Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition conditions: Cardiogenic Shock studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 125 type: ESTIMATED name: Data Acquisition measure: Collection of hemodynamic parameters (Cardiac Output in l/min) measure: Collection of hemodynamic parameters (Blood Pressure in mmHg, Pulmonary Artery Pressure in mmHg, Central Venous Pressure in mmHg, Pulmonary Capillary Wedge Pressure in mmHg) measure: Collection of hemodynamic parameters (Mixed Venous Saturation in %) measure: Collection of hemodynamic parameters (Pulmonary Vascular Resistance in In dynes/sec/cm-5 ) measure: Rate of Patient Survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06308042 id: 2024/5558 briefTitle: Remote Evaluation in Patients With Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-03-11 date: 2024-06-24 date: 2024-06-29 date: 2024-03-13 date: 2024-03-13 name: Inonu University class: OTHER briefSummary: This study aimed to demonstrate the remote reliability of the 30-second sit-to-stand test in patients with multiple sclerosis. conditions: Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 10 type: ESTIMATED name: 30 second sit and stand test measure: 30 second sit and stand test sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06308029 id: Edge003203 id: T001122N type: OTHER_GRANT domain: Research Foundations Flanders id: s68058 type: OTHER domain: UZ/KU Leuven ID briefTitle: Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment acronym: PECAN overallStatus: RECRUITING date: 2024-04-12 date: 2027-03-20 date: 2028-03-20 date: 2024-03-13 date: 2024-04-15 name: Universiteit Antwerpen class: OTHER name: Universitaire Ziekenhuizen KU Leuven name: University Ghent name: KU Leuven name: University Hospital, Antwerp briefSummary: The scientific goals of the project are:

1. The primary scientific objective of the study is to determine the effectiveness of an eHealth self-management support program for persistent pain after breast cancer treatment compared to:

   * usual care (i.e. superiority of the eHealth self-management support program) and
   * a comprehensive pain rehabilitation program delivered face-to-face in a physical therapy setting (i.e. non-inferiority of the eHealth self-management support program)

   on pain-related disability (measured with the Pain Disability Index).
2. The secondary scientific objectives of this study entails to examine if the eHealth self-management support program has a relative benefit for other biopsychosocial factors, including:

   * Other dimensions of pain
   * Health-related quality of life
   * Physical functioning, including physical activity levels
   * Psychosocial functioning, including self-efficacy, stress, anxiety, depression, coping style (key secondary outcome) and fear of cancer recurrence
   * Participation in society, including return to work
   * Healthcare-related costs for the patient and society
3. The tertiary scientific objectives of this study are

   * to identify moderators of treatment effect, including behavioural determinants (e.g. self-efficacy, motivation, coping style), in order to identify breast cancer survivors who would benefit the most of the eHealth self-management support program and to allow more stratified and efficient pain management care and more targeted allocation of budgets.
   * To examine the implementation process, mechanisms of impact and contextual factors. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pragmatic randomized, multi-centric, three-arm controlled trial primaryPurpose: TREATMENT masking: NONE count: 270 type: ESTIMATED name: eHealth self-management support program name: Face-to-face rehabilitation program measure: Pain-related disability measure: Pain related disability measure: Pain severity measure: Severity of neuropathic Pain measure: Medication use measure: Pain location measure: Knowledge of neurophysiology of pain measure: Physical Activity pattern measure: Physical functioning measure: Fatigue measure: Sleep disturbance measure: Pain Beliefs measure: Pain-related worrying measure: Vigilance to bodily sensations measure: Depression measure: Anxiety measure: Determinants for physical activity measure: Participation measure: Well-being measure: Social Support measure: Return to work rate measure: Medical costs of medical consumption measure: Indirect costs related to disease outside health care measure: Health-related quality of life measure: Patient Global Impression of Change sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universiteit Antwerpen status: RECRUITING city: Antwerpen country: Belgium name: An De Groef, PhD role: CONTACT email: an.degroef@uantwerpen.be name: Lore Dams, PhD role: CONTACT email: lore.dams@uantwerpen.be lat: 51.21989 lon: 4.40346 facility: KU Leuven status: RECRUITING city: Leuven country: Belgium name: Nele Devoogdt, PhD role: CONTACT email: nele.devoogdt@kuleuven.be name: An De Groef, PhD role: CONTACT email: an.degroef@kuleuven.be lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06308016 id: 25/IRE/23 briefTitle: Study of the Risk of Pharyngocutaneous Fistula in a Population of Patients Undergoing Total Laryngectomy and Creation of a Score for Pre-operative Risk Stratification. overallStatus: RECRUITING date: 2023-12-01 date: 2024-12-01 date: 2024-12-01 date: 2024-03-13 date: 2024-03-13 name: Regina Elena Cancer Institute class: OTHER briefSummary: Multicenter retrospective study of a cohort of patients affected by laryngeal carcinoma and subjected to total laryngectomy surgery at the centers participating in the reference period and responding to inclusion criteria. conditions: Laryngeal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 500 type: ESTIMATED measure: Identification of risk factors measure: Stratify patients sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: "Regina Elena" National Cancer Institute status: RECRUITING city: Rome zip: 00144 country: Italy name: Raul Pellini, MD role: CONTACT phone: ND email: raul.pellini@ifo.it name: Francesco Mazzola, Doctor role: CONTACT phone: 06 5266 4485 email: francesco.mazzola@ifo.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06308003 id: PTA CONF briefTitle: Effect of Surgical Approach on Postoperative Bleeding in Patien Arthroplasty overallStatus: RECRUITING date: 2023-02-13 date: 2025-04 date: 2025-09 date: 2024-03-13 date: 2024-03-13 name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio class: OTHER briefSummary: The study is, in accordance with current legislation, definable as monocentric Prospective Observational.

The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.

adult patients who will undergo surgery of hip arthroplasty.

Patients will undergo:

Preoperative T0: clinical visit/medical history, completion of the VAS questionnaire, Blood sampling to assess hemoglobin values Operative T1: hip arthroplasty surgery using one of the surgical approaches routinely used within our Institute T2 - Postoperative at 1 day from T1: VAS questionnaire, evaluation of any Adverse events T3 - Postoperative at 3 days from T1: blood loss based on the values of hemoglobin (Hb), assessment of any adverse events, and VAS questionnaire T4- Post operative at 45 days +/- 10 days from T1: evaluation of any events adverse, follow-up visit. conditions: Hip Arthropathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Anterior hip arthroplasty measure: The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Clinico San Siro status: RECRUITING city: Milan country: Italy name: Elena Cittera role: CONTACT phone: 0283502224 email: elena.cittera@grupposandonato.it name: Alberto Ventura role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06307990 id: 05M202 briefTitle: Understanding, Diagnosis and Monitoring of Thyroid Hormone Action Defects acronym: ADAM-THAD overallStatus: RECRUITING date: 2023-01-01 date: 2024-12-31 date: 2025-04-30 date: 2024-03-13 date: 2024-03-13 name: Istituto Auxologico Italiano class: OTHER name: ASST Fatebenefratelli Sacco name: Federico II University briefSummary: The goal of this observational study is to learn about the neurological and cardiological phenotype of patients with resistance to thyroid hormone (RTH) syndromes beta and alpha (RTHß and RTHa) due to dominant negative variants in the genes encoding the thyroid hormone receptors alpha (THRA) and beta (THRB).

The main question\[s\] it aims to answer are:

* Define frequency and improve early diagnosis for RTH syndromes
* Developing tools to accelerate diagnosis of RTH syndromes
* Development and validation of monitoring tools

Participants, recruited at neonatal screening or from cohorts of patients with unexplained specific neuro-cognitive or cardiovascular phenotypes will be submitted to biochemical and genetic investigations. In addition pluripotent stem cells will be generated from peripheral blood cells of RTHs patients and studied in vitro to understand the molecular mechanisms underlying neurological and cardiovascular consequences. In vitro and clinical data, will be correlated to identify biomarkers for monitoring treatment. conditions: Resistance, Thyroid Hormone studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: NGS sequencing name: serological tests measure: to define the frequency and improve early diagnosis for RTH syndromes. measure: to demonstrate that zebrafish zygotes are useful for screening of the pathogenicity of new TR mutations measure: Direct differentiation of THRA mutant patients-derived human induced pluripotent stem cells (hiPSCs) to neural progenitors (hiPSc-CNeu) and cardiomyocyte (hiPSC-CMs) measure: To identify TH-target genes involved in determining stemness, proliferation potential and differentiation of hiPSC measure: to define the prevalence of RTH syndromes in specific cohorts of patients with unexplained phenotypes measure: Generation of a comprehensive RTH database sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano IRCCS status: RECRUITING city: Milan zip: 20145 country: Italy name: Irene Campi, MD, PhD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Department of Endocrine & Metabolic Diseases, San Luca Hospital status: RECRUITING city: Milan country: Italy name: Luca Persani, Prof role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06307977 id: R01DA059272 type: NIH link: https://reporter.nih.gov/quickSearch/R01DA059272 briefTitle: Couples Motivational Interviewing to Reduce Drug Use and HIV Risk in Vulnerable Male Couples acronym: CHP overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2028-01 date: 2029-02 date: 2024-03-13 date: 2024-04-08 name: Hunter College of City University of New York class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: This study utilizes a randomized controlled trial design to evaluate the efficacy of couples motivational interviewing (MI) to reduce the frequency and severity of illicit drug use and frequency of HIV transmission risk behavior (TRB). Participants are randomized to one of two conditions: couples MI or standard couples HIV testing and counseling (CHTC). conditions: Substance Use conditions: HIV Infections studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: This study utilizes a randomized controlled trial design to evaluate the efficacy of couples motivational interviewing (MI) to reduce the frequency and severity of illicit drug use and frequency of HIV transmission risk behavior (TRB). Participants are randomized to one of two conditions: couples MI or standard couples HIV testing and counseling (CHTC). primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 360 type: ESTIMATED name: Couples Health Project measure: Drug use Frequency measure: Urine assay for drug use measure: CAS with casual partners measure: Bacterial sexually transmitted infections measure: Binge Drinking measure: PrEP Uptake sex: MALE minimumAge: 18 Years maximumAge: 34 Years stdAges: ADULT facility: Wayne State University city: Detroit state: Michigan zip: 48201 country: United States name: Angulique Outlaw, PHD role: CONTACT email: aoutlaw@med.wayne.edu lat: 42.33143 lon: -83.04575 facility: Hunter College city: New York state: New York zip: 10018 country: United States lat: 40.71427 lon: -74.00597 facility: University of Virginia city: Charlottesville state: Virginia zip: 22904 country: United States name: Karen Ingersoll role: CONTACT email: kes7a@virginia.edu lat: 38.02931 lon: -78.47668 hasResults: False

 nctId: NCT06307964 id: 69HCL23_1137 id: ID-RCB type: OTHER domain: 2024-A00480-47 briefTitle: Intra-Hepatic Microbiota in Alcoholic Hepatitis acronym: HepMAH overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-01 date: 2026-07 date: 2024-03-13 date: 2024-03-13 name: Hospices Civils de Lyon class: OTHER briefSummary: Alcoholic hepatitis (AH) is a serious complication of alcoholic liver disease (ALD). The histological presentation of AH is characterized by neutrophilic lobular inflammation, macrovesicular steatosis, hepatocyte ballooning and necrosis and the presence of Mallory bodies. In cases of severe HA, defined by a modified Maddrey score of 32 or above, mortality at 1 month is estimated at between 10 and 50%. The only treatment to reduce early mortality is corticosteroid therapy. However, only 60% of patients respond to corticosteroids, and no benefit has been demonstrated on late mortality. Identifying new therapeutic targets is therefore a major challenge in this disease.

Numerous pre-clinical studies and human data suggest the involvement of the intestinal microbiota in the pathogenesis of AH. Translocation of viable bacteria and microbial products from the digestive tract to the liver contributes to local and systemic inflammation, hepatocyte death and fibrogenesis. However, the intrahepatic microbial environment has never been characterized in HA.

The study hypothesis is that the intrahepatic microbiota is modulated by bacterial translocation and is associated with clinical outcomes.

The aim of this study is to determine the composition of the intrahepatic (obtained from transjugular liver biopsy), blood and fecal microbiota in patients with suspected severe AH from a monocentric prospective cohort in the Hepatology Department at Croix-Rousse Hospital (Lyon). Fifty consecutive patients with clinical suspicion of AH and indication for transjugular liver biopsy will be included. About thirty-five patients are expected in the confirmed AH group, and 15 in the group "alcoholic liver disease with no AH", based on data from the literature. The composition of the various microbiota will be determined by sequencing the 16S rRNA gene, and the results will be correlated with clinical data (corticosteroid sensitivity, overall survival, transplant-free survival, MELD score in particular) and histological data.

This exploratory study will enable to analyze the intra-hepatic microbiota, and to study its link with intra-hepatic inflammation and the clinical course of patients with AH. The data generated by HepMAH will thus help identify potential new therapeutic targets linked to the gut microbiota, and provide a scientific basis for the development of therapeutic interventions targeting the microbiota in HA. conditions: Cirrhosis conditions: Alcoholic Liver Disease conditions: Alcoholic Hepatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Biological sampling measure: Microbiota composition sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06307951 id: JCDC/BHR/24/012 briefTitle: Exploration of Infant and Young Child Feeding Practices and Their Determinants overallStatus: RECRUITING date: 2023-04-25 date: 2025-11-30 date: 2025-11-30 date: 2024-03-13 date: 2024-03-13 name: Hirabai Cowasji Jehangir Medical Research Institute class: OTHER briefSummary: The goal of this observational study is to assess infant and young child-feeding practices among women living in urban areas and slums in Pune and rural areas around Pune, India, and to investigate the reasons for the adopted infant and young child-feeding practices in Slum-dwelling women aged 18 to 49 years who have an infant/s less than 24 months of age.

The main question it aims to answer are:

* Are infant and young child-feeding practices among women living in urban areas and slums appropriate?
* What the reasons for the adopted infant and young child-feeding practices in Slum-dwelling women Participants will be measured for their height and weight, interviewed for Socio-demographic characteristics, birth history of the infant, infant feeding indicators and will be involved in focused group discussions and in-depth interviews to gain understanding into their adopted appropriate and inappropriate feeding practices. conditions: Infant studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 510 type: ESTIMATED name: No intervention measure: Infant and young child-feeding practices among women living in urban areas and slums in Pune and rural areas around Pune, India will have been assessed measure: Reasons for the adopted infant and young child-feeding practices will have been investigated sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Hirabai Cowasji Jehangir Medical Research Institute status: RECRUITING city: Pune state: Maharashtra zip: 411001 country: India name: Anuradha V. Khadilkar, MBBS,MD role: CONTACT phone: 9850244305 email: anuradhavkhadilkar@gmail.com name: Rubina M. Mandlik, Ph.D. role: CONTACT phone: 9922959588 email: rubymandlik@hotmail.com lat: 18.51957 lon: 73.85535 hasResults: False

 nctId: NCT06307938 id: 619020 briefTitle: Circulating Tumor DNA in Patients Summoned for Colonoscopy; - a Liquid Biopsy for Detection, Characterization, Individualized Treatment and Follow-up of Colorectal Cancer acronym: CoLiQ overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2027-12 date: 2027-12 date: 2024-03-13 date: 2024-03-13 name: Helse Nord-Trøndelag HF class: OTHER name: Norwegian University of Science and Technology briefSummary: CoLiQ is an observational study designed to evaluate the clinical usefulness of circulating tumor DNA (ctDNA) markers found in blood, as a liquid biopsy for diagnosis, prognosis and follow-up of colorectal cancer. The main questions it aims to answer are: 1) Can a panel of ctDNA markers identify CRC patients among the other patients summoned for colonoscopy? and 2) Does the type, number and level of ctDNA markers vary with the subtype and clinical course of CRC? Participants will be asked to answer a questionnaire and give a blood sample at inclusion. In addition, patients with CRC will be asked to give an extra test tube at their routine treatment and follow-up blood sampling. conditions: Colorectal Cancer conditions: Colorectal Adenoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED name: liquid biopsy measure: Colorectal cancer measure: Colorectal adenoma measure: Inflammatory bowel disease measure: Recurrence measure: Death measure: Treatment response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06307925 id: HC010-001 briefTitle: A Phase I Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of HC010 in Patients With Advanced Solid Tumors overallStatus: RECRUITING date: 2024-03-27 date: 2025-12-31 date: 2025-12-31 date: 2024-03-13 date: 2024-04-10 name: HC Biopharma Inc. class: INDUSTRY briefSummary: This clinical trial is a multicenter, open, single-arm, non-randomized, dose-escalation and dose-expansion, phase I clinical study in patients with advanced recurrent or metastatic solid tumors.The goal of this study is to evaluate the safety and tolerability of HC010 monotherapy in patients with advanced solid tumors. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 122 type: ESTIMATED name: HC010 measure: Incidence of dose-limiting toxicity measure: Adverse events measure: serious adverse events measure: Maximum Tolerated Dose measure: Recommended Dose for Phase II Clinical Studies measure: pharmacokinetics:Cmax measure: Objective response rate measure: duration of response measure: progression-free survival measure: overall survival measure: Disease control rate measure: pharmacokinetics:AUC0-last measure: pharmacokinetics:tmax measure: pharmacokinetics:Vd sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center status: RECRUITING city: Guangzhou state: Guangdong country: China name: Li Zhang, MD role: CONTACT phone: +86 139 0228 2893 email: zhangli@sysucc.org.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06307912 id: 202301 briefTitle: Physiotherapists' Placebo or Nocebo Communication Regarding VR overallStatus: COMPLETED date: 2023-11-01 date: 2023-12-01 date: 2023-12-01 date: 2024-03-13 date: 2024-03-13 name: HAN University of Applied Sciences class: OTHER briefSummary: Rationale: Chronic musculoskeletal pain (CMP) is a common and disabling condition. Physiotherapy is the most frequently administered nonpharmacological treatment option for patients with CMP and recently virtual reality (VR) was introduced in physiotherapy care as a novel treatment modality. Proper communication about physiotherapy treatment (modalities) is important to improve treatment outcomes, by applying placebo effects enhancing communication and avoiding nocebo effects enhancing communication. However, yet is still unknown to what extent this applies to communication of physiotherapists about VR in healthy participants.

Objective: To determine the effect of physiotherapists' placebo or nocebo therapeutic communication about VR, on treatment credibility and expectation in healthy participants.

Study design: Web-based randomized controlled trial.

Study population: 126 participants

Intervention: The placebo intervention group will be shown an educational video about VR, containing placebo effects enhancing verbal language. The nocebo intervention group will be shown an educational video about VR, containing nocebo effects enhancing verbal language.

Primary study parameters: The primary study parameters are treatment credibility and treatment expectation. Treatment credibility and treatment expectations will be measured using the Dutch credibility and expectancy questionnaire (CEQ). conditions: Communication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 126 type: ACTUAL name: Video placebo communication name: Video nocebo communication measure: Change in treatment expectancy measured using the Credibility and Expectancy Questionnaire (CEQ) measure: Change in treatment credibility measured using the Credibility and Expectancy Questionnaire (CEQ) measure: Change in openness to VR measured using a single question sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: HAN University of Applied Sciences city: Nijmegen state: Overijssel zip: 6525EN country: Netherlands lat: 51.8425 lon: 5.85278 hasResults: False

 nctId: NCT06307899 id: E-77082166-302.08.01-639069 briefTitle: Immediate Effects of Different Stretching Methods for Pectoralis Minor Muscle overallStatus: RECRUITING date: 2023-09-11 date: 2024-07-03 date: 2024-09-04 date: 2024-03-13 date: 2024-03-13 name: Gazi University class: OTHER briefSummary: The aim of our study is to compare the effects of different stretching methods for the pectoralis minor (PM) muscle on scapula position, PM muscle length and scapular muscle activation in individuals with shoulder protraction. Unilateral corner stretching, manual stretching and proprioceptive neuromuscular facilitation (PNF) stretching methods will be applied randomly, 2 days apart, to volunteer individuals who agree to participate in our study. Three different stretching methods (unilateral corner stretching, manual stretching and PNF stretching) will be applied to individuals randomly, 48 hours apart, and PM length, PM index, scapula upward rotation and EMG values will be recorded by a blind evaluator before and after the stretching application. conditions: Rounded Shoulder Posture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 25 type: ESTIMATED name: Unilateral Corner Stretch name: Manual Stretching name: PNF Stretching measure: Pectoralis Minor Length measure: Pectoralis Minor Length measure: Pectoralis Minor Index measure: Pectoralis Minor Index measure: Scapula Upward Rotation Measurement measure: Scapula Upward Rotation Measurement measure: EMG Analysis measure: EMG Analysis sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Gazi University status: RECRUITING city: Ankara state: Çankaya zip: 06490 country: Turkey name: Tuğçe Çoban, MSc role: CONTACT phone: +905454098540 email: fzttugce@yahoo.com lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06307886 id: GaziosmanpasaTREHSs briefTitle: Comparison of Five-year Survival and Disease-free Survival in Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With and Without Uterine Manipulator overallStatus: RECRUITING date: 2023-09-01 date: 2024-09-01 date: 2028-09-01 date: 2024-03-13 date: 2024-03-13 name: Gaziosmanpasa Research and Education Hospital class: OTHER_GOV briefSummary: Comparison of five-year survival and disease-free survival in patients diagnosed with endometrium cancer who underwent total laparoscopic hysterectomy with and without a uterine manipulator conditions: Endometrial Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 108 type: ESTIMATED name: Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With manipulator name: lPatients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy without uterine manipulator measure: five year survival in patients diagnosed with endometrial cancer measure: disease-free survival in patients diagnosed with endometrial cancer sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gaziosmanpasa Training and research hospital status: RECRUITING city: Istanbul country: Turkey name: Süleyman Salman, Professor role: CONTACT phone: +905059345470 email: sleymansalman@gmail.com name: Havva Betül Bacak, Specialist role: CONTACT phone: +905333610088 email: hbbacak90@gmail.com name: Fatma Ketenci Gencer, Associate Professor role: SUB_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06307873 id: GaziosmanpasaTREH. briefTitle: Comparison of the Effects of Sacrospinous Fixation and V-notes Lateral Suspension Operations overallStatus: RECRUITING date: 2023-09-01 date: 2024-09-01 date: 2025-09-01 date: 2024-03-13 date: 2024-03-13 name: Gaziosmanpasa Research and Education Hospital class: OTHER_GOV briefSummary: Comparison of the effects of sacrospinous fixation and v-notes lateral suspension operations on anatomical recovery, effectiveness and quality of life in a training and research hospital gynecology and obstetrics clinic. conditions: Genital Prolapse, Unspecified studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: pre and post operative POP-Q results name: pre and post operative PİSQ-12 results measure: Pre and post operative assessment of POP-Q measurements measure: Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual sex: FEMALE minimumAge: 35 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gaziosmanpasa Training and Research Hospital status: RECRUITING city: Istanbul country: Turkey name: Süleyman Salman, Professor role: CONTACT phone: +905059345470 email: sleymansalman@gmail.com name: Havva Betül Bacak, Specialist role: CONTACT phone: +905333610088 email: hbbacak90@gmail.com name: Fatma Ketenci Gencer, Associate Professor role: SUB_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06307860 id: 15270977512@163.com briefTitle: Comparison of Different Ablation Surgeries on Left Atrial Reverse Remodeling in Patients With Atrial Fibrillation overallStatus: RECRUITING date: 2022-06-01 date: 2024-06-30 date: 2025-03-01 date: 2024-03-13 date: 2024-03-15 name: Yun Wan class: OTHER briefSummary: The goal of this Ambispective cohort Study is to compare in patients with paroxysmal atrial fibrillation undergo pulse field ablation and radiofrequency ablation, respectively. The main question it aims to answer are:Comparison of the therapeutic effects of pulse field ablation and traditional thermal ablation on patients with paroxysmal atrial fibrillation and postoperative left atrial reverse remodeling.Participants will Perform pulse field ablation or radiofrequency ablation according to different groups, and cooperate to complete outpatient follow-up 6 months after surgery. conditions: Atrial Fibrillation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 120 type: ESTIMATED name: pulsed field ablation name: radiofrequency ablation measure: Recurrence rate of atrial arrhythmias measure: Left atrial end diastolic diameter measure: p wave dispersion measure: Pulmonary vein stenosis rate measure: Postoperative complications sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ganzhou People's Hospital status: RECRUITING city: Ganzhou state: Jiangxi zip: 341000 country: China name: Wan Yun, Bachelor role: CONTACT phone: 15270977512 email: 15270977512@163.com name: Luo Jun, doctor role: CONTACT phone: 13970107015 email: luojun1966@163.com hasResults: False

 nctId: NCT06307847 id: SP-HA-003 briefTitle: Pivotal Study to Evaluate Efficacy and Safety of SP5M001 Inj. as Compared to Synovian Inj. in Patients With Mild to Moderate Knee Osteoarthritis overallStatus: COMPLETED date: 2021-04-14 date: 2022-10-25 date: 2022-10-25 date: 2024-03-13 date: 2024-03-13 name: Shin Poong Pharmaceutical Co. Ltd. class: INDUSTRY briefSummary: This is a randomized, double-blind, multicenter, non-inferiority, pivotal clinical trial to assess the efficacy and safety of the novel hexamethylenediamine (HMDA) cross-linked hyaluronate intra-articular injection (SP5M001) compared with an active comparator, the 1,4-butanediol diglycidyl ether (BDDE) cross-linked hyaluronate (Synovian) in patients with knee osteoarthritis. conditions: Osteoarthritis Thumb studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 223 type: ACTUAL name: SP5M001 inj name: Synovian inj measure: Change in [Weight-Bearing Pain (WBP)-100mm-visual analogue scale (VAS)] at Week 12 from baseline (visit 2) measure: Changes in the following at each visit : Weight Bearing pain(WBP) (Weeks 2, 6, 24, and 36) from baseline (Visit 2) measure: Changes in the following at each visit : Rest pain (RP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) measure: Changes in the following at each visit : Night pain (NP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) measure: Changes in the following at each visit : Motion pain (MP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) measure: Changes in the following at each visit : Patient Global Assessment(PGA) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) measure: Changes in the following at each visit : Investigator Global Assessment (IGA) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) measure: Changes in the following at each visit : Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total score and individual score evaluation (Pain, function, stiffness) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) measure: Physical assessments at each post-administration visit: Swelling (Weeks 2, 6, 12, 24, and 36) measure: Physical assessments at each post-administration visit: joint-line tenderness on pressure (Weeks 2, 6, 12, 24, and 36) measure: Physical assessments at each post-administration visit: range of motion (Weeks 2, 6, 12, 24, and 36) measure: Proportion of participants who took rescue medication at each post-administration visit and dose of rescue medication (Weeks 2, 6, 12, 24, and 36) measure: Post-administration response rate A. Proportion at which WBP decreases by at least 20 mm or improves by at least 40% from baseline at the time of evaluation (B section-Description) measure: The incidence rate of Pre-treatment AEs measure: The incidence rate of Solicited Local AEs measure: The incidence rate of treatment-emergent adverse event (TEAE) measure: The incidence rate of Serious TEAEs measure: The incidence rate of Serious TEAEs leading to Drug withdrawn measure: The incidence rate of Serious TEAEs leading to Death measure: The incidence rate of abnormal CS at Post-Treatment on Laboratory measure: The incidence rate of abnormal CS at Post-Treatment on Electrocardiogram measure: The incidence rate of abnormal on Physical Examination sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yeungnam University Medical Center city: Daegu country: Korea, Republic of lat: 35.87028 lon: 128.59111 facility: Cheonam National University Hwasun Hospital city: Hwasun country: Korea, Republic of lat: 35.06125 lon: 126.98746 facility: Gachon University Gil Medical Center city: Incheon country: Korea, Republic of lat: 37.45646 lon: 126.70515 facility: Jeonbuk National University Hospital city: Jeonju country: Korea, Republic of lat: 35.82194 lon: 127.14889 facility: Chungnam National University Hospital city: Sejong country: Korea, Republic of lat: 36.59245 lon: 127.29223 facility: Seoul National University Bundang Hospital city: Seongnam-si country: Korea, Republic of lat: 37.43861 lon: 127.13778 facility: Asan Medical Center city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Chung-ang University Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Kyung Hee University Hospital at Gangdong city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Kyunghee University Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Samsung Medical Center city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Seoul National University Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Soon Chun Hyang University Hospital Seoul city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: The Catholic University of Korea, Seoul St. Mary's Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06307834 id: 26760 id: 24POST1194772 type: OTHER_GRANT domain: American Heart Association (AHA) briefTitle: Restoring Grasp Ability in Stroke Survivors Through MI-Based Training overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-06-30 date: 2025-12-31 date: 2024-03-13 date: 2024-03-13 name: North Carolina State University class: OTHER briefSummary: Stroke is a leading cause of disability. Most stroke survivors face challenge in using their arm and hand to carry out daily task, such as grasping or holding objects. This issue makes it tough for nearly 65% of stroke survivors to return to work and take care of themselves. The cause of their disability is changes in their brain's activity patterns of the motor cortex area. Traditional therapy does not directly alter these brain changes, which makes it less effective. As a way to help stroke survivors, people are looking into ways to train the brain directly. A method they found is motor imagery, which involves mental practicing of a task. Studies suggest that this type of training can potentially alter the brain's patterns, which can be seen through EEG. An EEG shows a fixed pattern during movement, called SMR (sensory motor rhythm). Studies have found that people can learn to control this SMR through mental practice of a task. The SMR changes in a similar way during both movement and motor imagery. Therefore, mental practice of hand tasks can lead to improvement in actual hand movements. It has already been shown that stroke survivors can open their hands more easily after receiving SMR training. Along with that, they also have trouble to hold and release objects. SMR training may be able to address these issues by changing brain patterns. But it is not clear yet if SMR training can improve all three stages of grasping (open, close, release), and to what extent it can enhance overall hand function.

This study plans to include 20 adults who have experienced a stroke and have ongoing problems with moving their hands. Half of these participants will take part in a training in which they will learn to control their SMR for three distinct hand tasks (open, close, and release). The first session will be followed by eight training sessions. To guide users toward specific changes in EEG activity, we will provide visual feedback in training. As soon as an appropriate EEG change is made, a hand exoskeleton will help them open and close their hand. The other group of 10 patients will have traditional therapy. They will do 9 sessions of hand exercises. During and after the training, we will test both groups to see how well their hand function improved. The result will help us determine which training method is better for stroke survivors. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Neurofeedback - based therapy name: Standard hand exercise therapy measure: Change of Box & Block test (BBT) measure: Change of Action Research Arm Test (ARAT) measure: Change of Wolf Motor Function Test (WMFT) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hand Rehabilitation Lab city: Raleigh state: North Carolina zip: 27695 country: United States name: Rinku Roy, PhD role: CONTACT phone: 212-731-4114 email: rroy2@ncsu.edu name: Derek G Kamper, PhD role: CONTACT phone: 9195154411 email: dgkamper@ncsu.edu lat: 35.7721 lon: -78.63861 hasResults: False

 nctId: NCT06307821 id: WK2024002 briefTitle: the Role of Probiotic in Protein Metabolism overallStatus: RECRUITING date: 2024-03-25 date: 2024-06-25 date: 2024-07-30 date: 2024-03-13 date: 2024-04-09 name: Wecare Probiotics Co., Ltd. class: INDUSTRY briefSummary: This study investigates the functional effects of probiotics on athletes by administering Weizmannella coagulans BC99 for six weeks. It aims to assess the probiotic's influence on skeletal muscle content, athletic performance, and protein digestion and metabolism. This is achieved by monitoring changes in digestive enzymes, amino acids, body composition, and hormone levels. The research seeks to offer a theoretical foundation for optimizing athletes' training and nutrition strategies and suggests the potential of probiotics in enhancing nutrient absorption and utilization, particularly in individuals with compromised digestive capabilities. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Double（Participant,Investigator） whoMasked: PARTICIPANT count: 70 type: ESTIMATED name: Probiotic measure: Digestibility and absorption of dietary protein sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Henan University of Science and Technology status: RECRUITING city: Luoyang state: Henan zip: 471000 country: China name: Ying Wu, Dr. role: CONTACT phone: +86 18639283502 email: wuying2000@126.com lat: 34.68361 lon: 112.45361 hasResults: False

 nctId: NCT06307808 id: Vitamin briefTitle: Viral Immunity in Solid Organ Transplant Recipients: Monitoring Of The Response To Hepatitis B Booster Vaccination acronym: VITAMIN overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-09-30 date: 2025-10-01 date: 2024-03-13 date: 2024-03-13 name: University Hospital, Grenoble class: OTHER name: National Agency for Research on AIDS and Viral Hepatitis (ANRS) briefSummary: Solid Organ Transplantation (SOT) is made possible by the use of a lifelong immunosuppressive treatment. This treatment limits the response of the immune system, enabling long-term survival of the transplanted organ, but also leading to weaker anti-infectious responses.

In this study, we will compare the response to a booster Hepatitis B vaccination (HBV) in SOT patients, either after kidney or liver transplantation. We will also compare the immune response depending on the immunosuppressive treatment.

In order to provide a detailed picture of the immune response, we will investigate the usual serological response (anti-HBs antibodies), but also the cellular memory (both T and B) using ELISpot assays and flow-cytometry, over a 6 months period following booster vaccination. conditions: HBV conditions: Kidney Transplantation conditions: Liver Transplantation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 66 type: ESTIMATED name: Tacrolimus name: Belatacept measure: Titer of anti-HBs ELISA antibody measure: Number of anti-HBs memory B cells sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Grenoble University Hospital city: Grenoble state: Aura zip: 38043 country: France name: Pr Thomas Jouve role: PRINCIPAL_INVESTIGATOR lat: 45.16667 lon: 5.71667 hasResults: False

 nctId: NCT06307795 id: ANS014004-I-US-01 briefTitle: A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-10 date: 2024-03-13 date: 2024-03-13 name: Avistone Biotechnology Co., Ltd. class: INDUSTRY briefSummary: This is a Phase 1, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary anti-tumor activity of ANS014004 as a single agent in participants with locally advanced or metastatic solid tumors. conditions: Locally Advanced or Metastatic Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 63 type: ESTIMATED name: ANS014004 measure: Incidence of Adverse Events (AEs) measure: Incidence of Serious Adverse Events (SAEs) measure: Incidence of dose-limiting toxicities (DLT) as defined in the protocol measure: Incidence of baseline laboratory finding, ECG and vital signs changes measure: Proportion of patients with radiological response (ORR) measure: Objective Response Rate (ORR) measure: Duration of Response (DoR) measure: Disease Control Rate (DCR) measure: Progression free Survival (PFS) measure: Overall Survival (OS) measure: Pharmacokinetics of ANS014004: Plasma PK concentrations measure: Pharmacokinetics of ANS014004: Area under the concentration time curve (AUC) measure: Pharmacokinetics of ANS014004: Maximum plasma concentration of the study drug (C-max) measure: Pharmacokinetics of ANS014004: Time to maximum plasma concentration of the study drug (T-max) measure: Pharmacokinetics of ANS014004: Clearance measure: Pharmacokinetics of ANS014004: Half-life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sarah Cannon Research Institute city: Denver state: Colorado zip: 80218 country: United States name: MD role: CONTACT lat: 39.73915 lon: -104.9847 facility: Advent Health city: Orlando state: Florida zip: 32804 country: United States lat: 28.53834 lon: -81.37924 facility: The University of Texas - MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States lat: 29.76328 lon: -95.36327 facility: NEXT Oncology, Virginia city: Fairfax state: Virginia zip: 22031 country: United States lat: 38.84622 lon: -77.30637 facility: Univ. of Washington Medical Center city: Seattle state: Washington zip: 98109-1024 country: United States lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06307782 id: 12833 briefTitle: The Effect of Oral Whey Consumption on Insulin Resistance, Cortisol, Crp, Albumin Level and Healing Quality Before Total Hip Arthroplasty acronym: WHEY THA overallStatus: ACTIVE_NOT_RECRUITING date: 2023-06-25 date: 2024-12-30 date: 2024-12-30 date: 2024-03-13 date: 2024-03-13 name: TC Erciyes University class: OTHER briefSummary: Purpose: It was planned to determine the effect of oral whey given before total hip arthroplasty (THA) on postoperative insulin resistance, cortisol, CRP((C reactive protein), albumin level and healing quality.

Design: It was planned as Randomized Controlled. Method: Research: The study is planned to include individuals aged 50-70, who are planned for THA in the orthopedics and traumatology clinic of a public hospital, who have undergone spinal anesthesia, who have BMI \<40 and ASA (American Society of Anesthesiologists)1,2,3. Individuals with endocrine or renal disorders or allergies to whey will be excluded from the study. It was planned to include at least 60 patients in the study (30 in the intervention group, 30 in the control group). It is planned to use the Patient Introduction Information Form, Physiological Measurements Chart (vital findings (blood pressure, pulse, respiratory SpO2 (pulse oximetry) value), blood glucose, cortisol, CRP and albumin value and insulin resistance) and postoperative recovery quality scale in data collection. The intervention group will be given 600 ml of oral whey 6 hours before the surgery, and the control group will be allowed to drink 600 ml of drinking water 6 hours before the surgery. 3ml of blood will be taken for blood glucose, CRP, cortisol, albumin and insulin resistance values 24 hours before the surgery, just before entering the surgery and 24 hours after the surgery. The first part of the healing quality scale is planned to be evaluated immediately before the surgery, and the second part 24 hours after the surgery.

Conclusion: When the literature was scanned, it was seen that the number of studies examining the effect of oral whey on metabolic and endocrine values in orthopedic patients was very limited and academic studies were needed. In this context, examining the effect of whey intake given before THA on the patient's blood glucose, CRP, albumin, cortisol, insulin resistance and healing quality is an original research that will contribute to the field. conditions: Crp conditions: Insulin Resistance conditions: Cortisol; Hypersecretion conditions: Albus; Lichen conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomize control trials primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: randomize clinical study whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: whey protein intake before surgery name: Water before surgery measure: Rate of C Reactive Protein measure: Rate of insulin resistance measure: Rate of albumen measure: Rate of cortisol measure: Healing Quality sex: ALL minimumAge: 50 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: HÜMEYRA city: Nevşehir state: Nevşehi̇r zip: 50000 country: Turkey lat: 38.625 lon: 34.71222 hasResults: False

 nctId: NCT06307769 id: 2024.02.42 briefTitle: Ten-meter Walking Test With Obstacle in Geriatric Individuals. overallStatus: RECRUITING date: 2024-03-05 date: 2024-05-15 date: 2024-05-25 date: 2024-03-13 date: 2024-03-13 name: Ataturk University class: OTHER briefSummary: Balance and fall problems are one of the most common geriatric syndromes in the elderly. Falls are one of the leading factors causing mortality in the elderly. One-third of individuals aged sixty-five and over fall once or more every year. When the causes of death in elderly individuals are examined; Accidents come in fifth place, and 2/3 of these accidents occur due to falls. The frequency of falls increases with age in 22% of individuals between the ages of 65-69. This rate is stated as 31% between the ages of seventy-five and seventy-nine, and 40% between the ages of 80-84.

Geriatric individuals may be at risk of falling in different situations, often inside and outside the home. Falls generally occur more frequently in indoor areas such as bathrooms, kitchens and bedrooms. In these areas, falls caused by potentially dangerous factors such as slippery floors, carpet edges, and high thresholds are more common. A frequent fall occurs when jumping over an obstacle. Factors such as poor balance, vision problems or reduced muscle strength when overcoming obstacles can increase the risk of falling in this situation. The ability of geriatric individuals to overcome obstacles during daily activities is an important factor determining quality of life. Climbing stairs or crossing high thresholds is an important part of daily living activities and poses a risk of falling. Therefore, determining the stair height threshold and assessing obstacle crossing skills should be considered effective measures. When the literature is examined, clinicians generally prefer simpler functional tests because assessments involving disabilities take a long time to be administered, involve some equipment, and also require training to perform the assessment. In the literature, there is currently a version of the functional tests that is applied only by adding obstacles to the timed get up and go test. Thanks to this test, the ability of geriatric individuals to overcome obstacles can be evaluated and people can be trained with this test. For this reason, we wanted to determine the suitability of the 10-meter walking test, which is frequently used in geriatric individuals, when applied with the addition of an obstacle. conditions: Geriatric conditions: Balance studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: Ten Meter Walk Test measure: Berg Balance Scale measure: Functional Reach Test measure: Timed up and go test sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ataturk University status: RECRUITING city: Erzurum country: Turkey name: Birol Önal, Dr. role: CONTACT phone: +904422311233 email: birol.onal@atauni.edu.tr lat: 39.90861 lon: 41.27694 hasResults: False

 nctId: NCT06307756 id: SayıNo:521 briefTitle: The Effect of Music on Maternal Stress and Milk Amount overallStatus: RECRUITING date: 2023-11-15 date: 2024-04-15 date: 2024-06-15 date: 2024-03-13 date: 2024-03-13 name: Adiyaman University class: OTHER briefSummary: Premature babies who have to deal with life-threatening situations have to spend the first days of their lives in intensive care units. Mothers who plan to return home with their babies during the postpartum period may experience stress due to their children being monitored in intensive care. It is stated that mothers of babies in the neonatal intensive care unit experience stress and anxiety due to reasons such as being separated from their babies, the baby's illness, the baby's sensitive body structure, the baby's appearance and behavior, and the baby's dependence on devices. This stress experienced by mothers of premature babies can prevent mothers from providing enough milk to feed their babies. Mothers whose babies are in the neonatal intensive care unit cannot have adequate contact with their babies and cannot breastfeed; It causes insomnia, stress and anxiety, and the hormonal axis is disrupted, negatively affecting the amount of breast milk. In order to support the healing process of preterm babies, it is important to increase the amount of milk produced by mothers and increase the rate at which babies can receive breast milk. Music improves endothelial function by dilating the vessels; It has been reported that it reduces mental stress by increasing the release of nitrite oxide and endorphins and causes many physiological reactions such as a decrease in blood pressure and pulse. This study will examine the effect of music played to mothers with premature babies on maternal anxiety and the amount of breast milk. conditions: Amount of Breast Milk conditions: Maternal Anxiety Level studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: Music group measure: amount of breast milk measured at the same time every day measure: State Anxiety Inventory sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Sağlık Bilimleri Üniversitesi Gazi Yaşargil Eğitim ve Araştırma Hastanesi status: RECRUITING city: Diyarbakır country: Turkey name: Özlem Sıdıka Kartal role: CONTACT phone: +90 05534452828 email: ozlem.kartal.002.@gmail.com lat: 37.91363 lon: 40.21721 hasResults: False

 nctId: NCT06307743 id: RAPID-SAVE briefTitle: Rapid Local Ischemic Postconditioning in Acute Ischemic Stroke acronym: RAPID-SAVE overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-06-15 date: 2025-09-15 date: 2024-03-13 date: 2024-03-13 name: Shanghai Jiao Tong University Affiliated Sixth People's Hospital class: OTHER name: Zhangzhou Municipal Hospital of Fujian Province name: Shanghai East Hospital name: First People's Hospital of Hangzhou name: RenJi Hospital briefSummary: The objective of this clinical trial is to determine whether rapid local ischemic postconditioning (RL-IPostC) is effective in preventing brain edema and safe in acute ischemic stroke (AIS) patients treated with mechanical thrombectomy. In this trial, researchers will block antegrade cerebral blood flow temporarily by the way of balloon inflation/deflation in AIS patients immediately after revascularization. It makes the ischemic reperfusion brain tissue have a capacity of adaptation through intermittent blood flow restoration. Researchers will evaluate the protective role and safety of different duration of balloon inflation/deflation. The optimal postconditioning intervention dose will be determined for further confirmative investigation. conditions: Acute Ischemic Stroke conditions: Mechanical Thrombectomy conditions: Ischemic Postconditioning conditions: Brain Edema studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 135 type: ESTIMATED name: rapid local ischemic postconditioning measure: Number of Participants without clinically meaningful cerebral swelling, significant increase in infarct volume from baseline and intervention-related serious adverse events. measure: Rate of participants without clinically meaningful cerebral swelling measure: Rate of participants with significant increase in infarct volume from baseline or intervention-related serious adverse events. measure: Change in volume of cerebrospinal fluid (∆CSF72) at 72 hours measure: Change of net water uptake (∆NWU24) at 24 hours measure: Change of net water uptake (∆NWU72) at 72 hours measure: Midline shift at 24 hours measure: Midline shift at 72 hours measure: Change of NIHSS at 24 hours measure: Early therapeutic response to treatment measure: Good outcome at 90 days measure: Excellent outcome at 90 days sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06307730 id: CHSD_0033_GERIATRIE briefTitle: Application of the Recommendations of the SPLIF (French Society of Infectious Pathology) in a Geriatric Population on the Duration of Treatment for Bacterial Pneumonia overallStatus: COMPLETED date: 2023-01-02 date: 2023-04-30 date: 2023-04-30 date: 2024-03-13 date: 2024-03-13 name: Centre Hospitalier de Saint-Denis class: OTHER briefSummary: Pneumopathy is the leading cause of death from infectious disease in the elderly. Prior to 2021, the recommended duration of antibiotic therapy for pneumonia, in adults, was 7 days.

Two theses have shown that these recommendations were poorly applied in geriatric services. Indeed, the duration of treatment exceeded 7 days, and less than 30% of antibiotic antibiotic treatments were re-evaluated at 72 hours.

In 2021, the SPLIF ( published new recommendations reducing this duration to 5 days in the event of clinical improvement observed on the 3rd day of treatment. These new recommendations are based on studies, in which the average age of participants was 65 years. However, the average age of patients in geriatric short-stay departments is 84.7 years.

In addition, the geriatric population is characterized by immunosenescence, pulmonary vulnerability and undernutrition, raising questions about the validity of these recommendations in the geriatric population.

The investigators offer a monocentric, retrospective, observational study of the geriatric hospital Casanova to assess the application of SPLIF recommendations in the geriatric population. conditions: Pneumonia, Bacterial conditions: Pneumopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 35 type: ACTUAL measure: Sex measure: Age measure: Weight measure: Phone Number measure: Origins measure: Autonomy in daily life's score before hospitalisation measure: Charlson's morbidity score sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hopitalier de Saint-Denis city: Saint-Denis state: Seine Saint Denis zip: 93200 country: France lat: 48.93326 lon: 2.36666 hasResults: False

 nctId: NCT06307717 id: PLAGH-DA-002 briefTitle: Effects of Volatile Anaesthetics on Incidence of Postoperative Depression and Anxiety in Elderly Patients overallStatus: COMPLETED date: 2020-04-01 date: 2021-10-31 date: 2022-04-30 date: 2024-03-13 date: 2024-04-10 name: Chinese PLA General Hospital class: OTHER name: Beijing Tsinghua Changgeng Hospital name: Peking University First Hospital name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School name: Xiangya Hospital of Central South University name: Beijing Anzhen Hospital name: Central South University name: Peking University People's Hospital name: Zhejiang University name: Fudan University name: Sun Yat-sen University name: Wuhan Union Hospital, China name: China-Japan Friendship Hospital name: The Affiliated Hospital Of Guizhou Medical University name: First Affiliated Hospital of Xinjiang Medical University name: First Affiliated Hospital of Guangxi Medical University name: Taihe Hospital briefSummary: This study is a retrospective analysis of a large-scale multicentre prospective cohort study that investigates the impact of volatile anaesthetics on the incidence of postoperative depression and anxiety among elderly patients. conditions: Cohort Studies studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 8000 type: ACTUAL name: volatile anaesthetic (sevoflurane, isoflurane, desflurane) measure: Depression measure: Anxiety sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Chinese PLA General Hospital city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06307704 id: LUSPEEPORRPC briefTitle: Lung US for PEEP Optimization in Robotic Radical Prostatectomy or Cystectomy Patients overallStatus: RECRUITING date: 2024-03 date: 2024-09 date: 2024-09 date: 2024-03-13 date: 2024-03-15 name: Nazmy Edward Seif class: OTHER briefSummary: There is an increasing trend in the use of robotic-assisted radical prostatectomy or cystectomy (RARPC).

Preventing lung atelectasis without inducing overdistention of the lung is challenging. Many studies tried to optimize PEEP titration by using methods such as dead space fraction guided and static pulmonary compliance directed techniques, or by using electrical impedance tomography. However, the use of these methods is limited by inaccuracy and the need for sophisticated devices.

Bedside Lung ultrasound is fast, easy and economic technique that is gaining interest in the operating room. Ultrasound-guided PEEP titration has been used in bariatric surgeries (different position and usually shorter procedure time) and proved effective in improving oxygenation, compliance and reducing the incidence of postoperative pulmonary atelectasis and hypoxia without causing hemodynamic instability.

The aim of this study is to evaluate the effectiveness of intraoperative individualized lung ultrasound-guided stepwise PEEP optimization in patients undergoing RARPC on oxygenation, intraoperative and early postoperative pulmonary complications. conditions: Prostate Cancer conditions: Urinary Bladder Cancer conditions: Surgery conditions: Positive End Expiratory Pressure conditions: Lung Ultrasound studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 88 type: ESTIMATED name: Lung Ultrasound - guided Stepwise PEEP name: Standard Ventilation Protocol measure: Post-operative lung consolidation sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo University Hospitals status: RECRUITING city: Cairo country: Egypt name: Mustafa E Mohamed, MD role: CONTACT phone: 01140806330 phoneExt: +2 email: mustafaemam931@gmail.com name: Nazmy S Mikhael, MD role: CONTACT phone: 01227400808 phoneExt: +2 email: nazmy.edwar.seif@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06307691 id: 11423 briefTitle: Clinical and Radiographic Evaluation of Immediate Implant Placement Using Osseodensification Versus Traditional Drilling Protocol overallStatus: RECRUITING date: 2024-03-06 date: 2025-12-20 date: 2026-12-20 date: 2024-03-13 date: 2024-03-19 name: Cairo University class: OTHER briefSummary: For the purpose of the study, patients will be divided into two groups, i.e., Group A and Group B. In Group (A), 14 immediate implants will be placed using traditional drilling technique, while in Group (B), 14 immediate implants will be placed using OD drilling technique Osseodensification is a system for implant osteotomy preparation, it compresses the cancellous bone around the revolving drills. It largely improves low bone volume by physically increasing the interlocking between the bone and the implant surface. The Densah burs enhances bone density while generating the least amount of heat.

Traditional oversized drilling is the regular manufacturer recommended technique of drilling. It functions by cutting the bone during osteotomy preparation by sharp fluted drills. The undersizing of the preparation allows the implant to partially compact the bone during insertion.

The objective of the current study is to compare between osseodensification drilling protocol versus traditional undersized drilling protocol in immediate implant placement in anterior maxillary region in terms of implant stability. conditions: Implant Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: patients will be randomly selected into either group using computer generated randomization using (www.randomizer.org). The randomized numbers will be allocated to each site in each patient and will be placed in opaque, sealed and sequentially numbered envelopes. patients will be randomly allocated to test and control groups using randomization schedule.

Masking/blinding:

* Participants will be blinded
* Blinding of the operator will be blinded
* The outcome assessor will be blinded
* The biostatistician will be blinded whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 26 type: ESTIMATED name: Conventional drilling name: Osseodensification drilling measure: Implant stability quotient (ISQ) measure: Crestal bone level sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Dentistry Cairo University status: RECRUITING city: Cairo country: Egypt name: Omar M Ibrahim, master role: CONTACT phone: 01000953710 phoneExt: 002 email: omar_ibrahim@dentistry.cu.edu.eg name: Omnia K Tawfik, PhD role: CONTACT phone: 01006002618 email: omnia.tawfik@dentistry.cu.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06307678 id: AtaturkU-DHF-MS-01 briefTitle: Effect of Calcium Silicate Based Root Canal Medicament on Inflammatory Mediators overallStatus: COMPLETED date: 2023-07-07 date: 2023-12-10 date: 2023-12-10 date: 2024-03-13 date: 2024-03-13 name: Ataturk University class: OTHER briefSummary: Calcium hydroxide is generally preferred in endodontics as an intracanal medicament because of its antimicrobial and biological effects. However, the antimicrobial effect of calcium hydroxide is limited.

The aim of this study was to investigate the effects of calcium silicate-based root canal medicament on the release of RANKL/OPG, TNF-α, PGE-2 and TGF-β1 in root canal treated teeth with periapical lesions. conditions: Periapical; Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: two groups: group 1 calcium hydroxide based medicament (control group) group 2: calcium silicate based medicament primaryPurpose: TREATMENT masking: SINGLE maskingDescription: outcome assessments have performed by a investigator who was blinded to groups. whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Calcium Hydroxide name: Calcium Silicate measure: preoperative and postoperative levels of RANKL/OPG ratio measure: preoperative and postoperative levels of prostaglandinE2 (PGE2) ratio measure: preoperative and postoperative levels of TNF alpha ratio measure: preoperative and postoperative levels of TGF beta ratio measure: dependent variables (sex, age, teeth number, smoking habit) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ataturk University city: Erzurum zip: 25240 country: Turkey lat: 39.90861 lon: 41.27694 hasResults: False

 nctId: NCT06307665 id: D6934C00001 briefTitle: Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma acronym: ACADIA overallStatus: NOT_YET_RECRUITING date: 2024-05-08 date: 2027-10-13 date: 2027-10-13 date: 2024-03-13 date: 2024-04-09 name: AstraZeneca class: INDUSTRY name: Parexel briefSummary: The purpose of this study is to compare the budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI) administered as needed on severe asthma exacerbations in adolescent participants aged 12 to \< 18 years with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year. conditions: Asthma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 440 type: ESTIMATED name: BDA MDI name: AS MDI measure: Annualized rate of severe asthma exacerbations (AAER) measure: Time to first (TTF) severe asthma exacerbation measure: Annualized total systemic corticosteroids (SCS) exposure for treatment of asthma measure: Number of participants with adverse events (AEs) and severe adverse events (SAEs) measure: Maximum Observed Concentration (Cmax) measure: Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) measure: Area under plasma concentration-time curve from time 0 to infinity (AUCinf) measure: Time to reach maximum concentration following drug administration (Tmax) measure: Time to reach maximum concentration following drug administration (Tlast) measure: Terminal elimination half-life (t½λz) measure: Terminal elimination rate constant (λz) measure: Apparent total body clearance (CL/F) measure: Apparent volume of distribution based on the terminal phase (Vz/F) sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: Research Site city: White Marsh state: Maryland zip: 21162 country: United States lat: 39.38372 lon: -76.43218 hasResults: False

 nctId: NCT06307652 id: D6402C00012 briefTitle: Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function acronym: BalanceD-HF overallStatus: NOT_YET_RECRUITING date: 2024-04-12 date: 2027-06-11 date: 2027-06-11 date: 2024-03-13 date: 2024-03-13 name: AstraZeneca class: INDUSTRY briefSummary: This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events. conditions: Heart Failure and Impaired Kidney Function studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 4800 type: ESTIMATED name: balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg name: balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg name: dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozin measure: Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation measure: Total occurrences (first and recurrent) of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation measure: Total occurrences (first and recurrent) of HF hospitalisations measure: Time to CV death measure: The hierarchical composite endpoint of death from any cause, total HF events, and change from baseline in KCCQ total symptom score to 24-week post-randomisation measure: Time to death from any cause sex: ALL minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site city: Alexander City state: Alabama zip: 35010 country: United States lat: 32.94401 lon: -85.95385 facility: Research Site city: Fairhope state: Alabama zip: 36532 country: United States lat: 30.52297 lon: -87.90333 facility: Research Site city: Little Rock state: Arkansas zip: 72205 country: United States lat: 34.74648 lon: -92.28959 facility: Research Site city: Los Angeles state: California zip: 90089 country: United States lat: 34.05223 lon: -118.24368 facility: Research Site city: Newport Beach state: California zip: 92663 country: United States lat: 33.61891 lon: -117.92895 facility: Research Site city: San Diego state: California zip: 92123 country: United States lat: 32.71533 lon: -117.15726 facility: Research Site city: Santa Ana state: California zip: 92704 country: United States lat: 33.74557 lon: -117.86783 facility: Research Site city: Thousand Oaks state: California zip: 91360 country: United States lat: 34.17056 lon: -118.83759 facility: Research Site city: Altamonte Springs state: Florida zip: 32701 country: United States lat: 28.66111 lon: -81.36562 facility: Research Site city: Clearwater state: Florida zip: 33756 country: United States lat: 27.96585 lon: -82.8001 facility: Research Site city: Jacksonville state: Florida zip: 32209 country: United States lat: 30.33218 lon: -81.65565 facility: Research Site city: Miami state: Florida zip: 33133 country: United States lat: 25.77427 lon: -80.19366 facility: Research Site city: Saint Augustine state: Florida zip: 32086 country: United States lat: 29.89469 lon: -81.31452 facility: Research Site city: Atlanta state: Georgia zip: 30303 country: United States lat: 33.749 lon: -84.38798 facility: Research Site city: Tucker state: Georgia zip: 30084 country: United States lat: 33.85455 lon: -84.21714 facility: Research Site city: Chicago state: Illinois zip: 60637 country: United States lat: 41.85003 lon: -87.65005 facility: Research Site city: Hazel Crest state: Illinois zip: 60429 country: United States lat: 41.5717 lon: -87.69449 facility: Research Site city: Hammond state: Indiana zip: 46324 country: United States lat: 41.58337 lon: -87.50004 facility: Research Site city: Munster state: Indiana zip: 46321 country: United States lat: 41.56448 lon: -87.51254 facility: Research Site city: Richmond state: Indiana zip: 47374 country: United States lat: 39.82894 lon: -84.89024 facility: Research Site city: Wichita state: Kansas zip: 67218 country: United States lat: 37.69224 lon: -97.33754 facility: Research Site city: Wichita state: Kansas zip: 67226 country: United States lat: 37.69224 lon: -97.33754 facility: Research Site city: Louisville state: Kentucky zip: 40202 country: United States lat: 38.25424 lon: -85.75941 facility: Research Site city: Alexandria state: Louisiana zip: 71301 country: United States lat: 31.31129 lon: -92.44514 facility: Research Site city: Shreveport state: Louisiana zip: 71105 country: United States lat: 32.52515 lon: -93.75018 facility: Research Site city: Augusta state: Maine zip: 04330 country: United States lat: 44.31062 lon: -69.77949 facility: Research Site city: Dearborn state: Michigan zip: 48126 country: United States lat: 42.32226 lon: -83.17631 facility: Research Site city: Flint state: Michigan zip: 48504 country: United States lat: 43.01253 lon: -83.68746 facility: Research Site city: Saint Paul state: Minnesota zip: 55102 country: United States lat: 44.94441 lon: -93.09327 facility: Research Site city: Kansas City state: Missouri zip: 64128 country: United States lat: 39.09973 lon: -94.57857 facility: Research Site city: Lincoln state: Nebraska zip: 68506 country: United States lat: 40.8 lon: -96.66696 facility: Research Site city: Somerset state: New Jersey zip: 08873 country: United States lat: 40.4976 lon: -74.48849 facility: Research Site city: Bronx state: New York zip: 10455 country: United States lat: 40.84985 lon: -73.86641 facility: Research Site city: Buffalo state: New York zip: 14215 country: United States lat: 42.88645 lon: -78.87837 facility: Research Site city: Chapel Hill state: North Carolina zip: 27517 country: United States lat: 35.9132 lon: -79.05584 facility: Research Site city: Greensboro state: North Carolina zip: 27405 country: United States lat: 36.07264 lon: -79.79198 facility: Research Site city: Cincinnati state: Ohio zip: 45267 country: United States lat: 39.12713 lon: -84.51435 facility: Research Site city: Maumee state: Ohio zip: 43537 country: United States lat: 41.56283 lon: -83.65382 facility: Research Site city: Abington state: Pennsylvania zip: 19001 country: United States lat: 40.12067 lon: -75.11795 facility: Research Site city: Camp Hill state: Pennsylvania zip: 17011 country: United States lat: 40.23981 lon: -76.91997 facility: Research Site city: Hershey state: Pennsylvania zip: 17033 country: United States lat: 40.28592 lon: -76.65025 facility: Research Site city: Horsham state: Pennsylvania zip: 19044 country: United States lat: 40.17844 lon: -75.12851 facility: Research Site city: Providence state: Rhode Island zip: 02908 country: United States lat: 41.82399 lon: -71.41283 facility: Research Site city: Rapid City state: South Dakota zip: 57701 country: United States lat: 44.08054 lon: -103.23101 facility: Research Site city: Jackson state: Tennessee zip: 38301 country: United States lat: 35.61452 lon: -88.81395 facility: Research Site city: Knoxville state: Tennessee zip: 37916 country: United States lat: 35.96064 lon: -83.92074 facility: Research Site city: Memphis state: Tennessee zip: 38128 country: United States lat: 35.14953 lon: -90.04898 facility: Research Site city: Nashville state: Tennessee zip: 37212 country: United States lat: 36.16589 lon: -86.78444 facility: Research Site city: Tullahoma state: Tennessee zip: 37388 country: United States lat: 35.36202 lon: -86.20943 facility: Research Site city: Cypress state: Texas zip: 77429 country: United States lat: 29.96911 lon: -95.69717 facility: Research Site city: El Paso state: Texas zip: 79905 country: United States lat: 31.75872 lon: -106.48693 facility: Research Site city: Houston state: Texas zip: 77025 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site city: Houston state: Texas zip: 77090 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site city: Katy state: Texas zip: 77493 country: United States lat: 29.78579 lon: -95.8244 facility: Research Site city: Odessa state: Texas zip: 79761 country: United States lat: 31.84568 lon: -102.36764 facility: Research Site city: Sherman state: Texas zip: 75092 country: United States lat: 33.63566 lon: -96.60888 facility: Research Site city: Falls Church state: Virginia zip: 22042 country: United States lat: 38.88233 lon: -77.17109 facility: Research Site city: Newport News state: Virginia zip: 23606 country: United States lat: 37.08339 lon: -76.46965 facility: Research Site city: Buenos Aires zip: 1425DES country: Argentina lat: -34.61315 lon: -58.37723 facility: Research Site city: Buenos Aires zip: C1056ABJ country: Argentina lat: -34.61315 lon: -58.37723 facility: Research Site city: Buenos Aires zip: C1180AAX country: Argentina lat: -34.61315 lon: -58.37723 facility: Research Site city: Buenos Aires zip: C1430EGF country: Argentina lat: -34.61315 lon: -58.37723 facility: Research Site city: Caba zip: C1425AGC country: Argentina lat: -34.61315 lon: 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lat: -26.82414 lon: -65.2226 facility: Research Site city: San Miguel de Tucuman zip: T4000ICL country: Argentina lat: -26.82414 lon: -65.2226 facility: Research Site city: Santa Fe zip: S3000FWO country: Argentina lat: -31.63333 lon: -60.7 facility: Research Site city: Chermside zip: 4032 country: Australia lat: -27.38472 lon: 153.03062 facility: Research Site city: Geelong zip: 3220 country: Australia lat: -38.14711 lon: 144.36069 facility: Research Site city: Braunau am Inn zip: 5280 country: Austria lat: 48.25628 lon: 13.04343 facility: Research Site city: Graz zip: 8036 country: Austria lat: 47.06667 lon: 15.45 facility: Research Site city: Linz zip: 4020 country: Austria lat: 48.30639 lon: 14.28611 facility: Research Site city: Saint Stefan/Stainz zip: 8511 country: Austria facility: Research Site city: Salzburg zip: 5020 country: Austria lat: 47.79941 lon: 13.04399 facility: Research Site city: St. Pölten zip: 3100 country: Austria lat: 48.2 lon: 15.63333 facility: Research Site city: Wien zip: 1090 country: Austria lat: 48.20849 lon: 16.37208 facility: Research Site city: Wien zip: 1100 country: Austria lat: 48.20849 lon: 16.37208 facility: Research Site city: Wien zip: 1160 country: Austria lat: 48.20849 lon: 16.37208 facility: Research Site city: New Westminster state: British Columbia zip: V3L 3W4 country: Canada lat: 49.20678 lon: -122.91092 facility: Research Site city: North Vancouver state: British Columbia zip: V7M 2H4 country: Canada lat: 49.31636 lon: -123.06934 facility: Research Site city: Vancouver state: British Columbia zip: V6Z 1Y6 country: Canada lat: 49.24966 lon: -123.11934 facility: Research Site city: Winnipeg state: Manitoba zip: R2H 2A6 country: Canada lat: 49.8844 lon: -97.14704 facility: Research Site city: Sydney state: Nova Scotia zip: B1P 1P3 country: Canada lat: 46.13511 lon: -60.1831 facility: Research Site city: Cambridge state: Ontario zip: N1R 6V6 country: Canada lat: 43.3601 lon: -80.31269 facility: Research Site city: London state: Ontario zip: N6A 5A5 country: Canada lat: 42.98339 lon: -81.23304 facility: Research Site city: Newmarket state: Ontario zip: L3Y 2P6 country: Canada lat: 44.05011 lon: -79.46631 facility: Research Site city: North York state: Ontario zip: M6B 3H7 country: Canada lat: 43.76681 lon: -79.4163 facility: Research Site city: Oshawa state: Ontario zip: L1J 2K1 country: Canada lat: 43.90012 lon: -78.84957 facility: Research Site city: Ottawa state: Ontario zip: K1Y 4W7 country: Canada lat: 45.41117 lon: -75.69812 facility: Research Site city: Peterborough state: Ontario zip: K9J 0B2 country: Canada lat: 44.30012 lon: -78.31623 facility: Research Site city: Toronto state: Ontario zip: M6G 1M2 country: Canada lat: 43.70011 lon: -79.4163 facility: Research Site city: Waterloo state: Ontario zip: N2T 0C1 country: Canada lat: 43.4668 lon: -80.51639 facility: Research Site city: Chicoutimi state: Quebec zip: G7H 7K9 country: Canada lat: 48.41963 lon: -71.06369 facility: Research Site city: Greenfield Park state: Quebec zip: J4V 2H1 country: Canada lat: 45.48649 lon: -73.46223 facility: Research Site city: Montreal state: Quebec zip: H3G 1A4 country: Canada lat: 45.50884 lon: -73.58781 facility: Research Site city: Montreal state: Quebec zip: H4J 1C5 country: Canada lat: 45.50884 lon: -73.58781 facility: Research Site city: St Jean sur Richelieu state: Quebec zip: J3A 1J2 country: Canada lat: 45.30713 lon: -73.26259 facility: Research Site city: Trois-Rivières state: Quebec zip: G9A 4P3 country: Canada lat: 46.34515 lon: -72.5477 facility: Research Site city: Antofagasta country: Chile lat: -23.65236 lon: -70.3954 facility: Research Site city: Santiago zip: 7500587 country: Chile lat: -33.45694 lon: -70.64827 facility: Research Site city: Santiago zip: 8330044 country: Chile lat: -33.45694 lon: -70.64827 facility: Research Site city: Temuco zip: 4781156 country: Chile lat: -38.73965 lon: -72.59842 facility: Research Site city: Temuco zip: 4810345 country: Chile lat: -38.73965 lon: -72.59842 facility: Research Site city: Valdivia zip: 5110683 country: Chile lat: -39.81422 lon: -73.24589 facility: Research Site city: Victoria zip: 4720097 country: Chile lat: -38.23291 lon: -72.33292 facility: Research Site city: Beijing zip: 100029 country: China lat: 39.9075 lon: 116.39723 facility: Research Site city: Beijing zip: 100730 country: China lat: 39.9075 lon: 116.39723 facility: Research Site city: Changsha zip: 430033 country: China lat: 28.19874 lon: 112.97087 facility: Research Site city: Chengdu zip: 610041 country: China lat: 30.66667 lon: 104.06667 facility: Research Site city: Hangzhou zip: 310014 country: China lat: 30.29365 lon: 120.16142 facility: Research Site city: Lanzhou zip: 730030 country: China lat: 36.05701 lon: 103.83987 facility: Research Site city: Nanjing zip: 210029 country: China lat: 32.06167 lon: 118.77778 facility: Research Site city: Wuhan zip: 430022 country: China lat: 30.58333 lon: 114.26667 facility: Research Site city: Xian zip: 710061 country: China lat: 34.25833 lon: 108.92861 facility: Research Site city: Barranquilla zip: 80007 country: Colombia lat: 10.96854 lon: -74.78132 facility: Research Site city: Bogotá country: Colombia lat: 4.60971 lon: -74.08175 facility: Research Site city: Cali zip: 760036 country: Colombia lat: 3.43722 lon: -76.5225 facility: Research Site city: Brno zip: 60200 country: Czechia lat: 49.19522 lon: 16.60796 facility: Research Site city: Brno zip: 639 00 country: Czechia lat: 49.19522 lon: 16.60796 facility: Research Site city: Broumov zip: 55001 country: Czechia lat: 50.58566 lon: 16.33181 facility: Research Site city: Ceska Lipa zip: 470 77 country: Czechia lat: 50.68551 lon: 14.53764 facility: Research Site city: Jaromer zip: 551 01 country: Czechia lat: 50.3562 lon: 15.92136 facility: Research Site city: Louny zip: 440 01 country: Czechia lat: 50.35699 lon: 13.79667 facility: Research Site city: Plzen - Bory zip: 305 99 country: Czechia lat: 49.74747 lon: 13.37759 facility: Research Site city: Plzen zip: 31001 country: Czechia lat: 49.74747 lon: 13.37759 facility: Research Site city: Praha 2 zip: 120 00 country: Czechia lat: 50.08804 lon: 14.42076 facility: Research Site city: Prerov zip: 75152 country: Czechia lat: 49.45511 lon: 17.4509 facility: Research Site city: Slany zip: 274 01 country: Czechia lat: 50.23046 lon: 14.08693 facility: Research Site city: Svitavy zip: 568 25 country: Czechia lat: 49.75594 lon: 16.46829 facility: Research Site city: Ustí nad Labem zip: 40011 country: Czechia lat: 50.6607 lon: 14.03227 facility: Research Site city: Zlin zip: 760 01 country: Czechia lat: 49.22645 lon: 17.67065 facility: Research Site city: Helsinki zip: 00290 country: Finland lat: 60.16952 lon: 24.93545 facility: Research Site city: Jyväskylä zip: 40620 country: Finland lat: 62.24147 lon: 25.72088 facility: Research Site city: Tampere zip: 33520 country: Finland lat: 61.49911 lon: 23.78712 facility: Research Site city: Turku zip: 20520 country: Finland lat: 60.45148 lon: 22.26869 facility: Research Site city: Beziers zip: 34500 country: France lat: 43.34122 lon: 3.21402 facility: Research Site city: Bron zip: 69667 country: France lat: 45.73333 lon: 4.91667 facility: Research Site city: Caen Cedex 9 zip: 14033 country: France lat: 49.18585 lon: -0.35912 facility: Research Site city: Creteil zip: 94010 country: France lat: 48.78333 lon: 2.46667 facility: Research Site city: Dijon zip: 21079 country: France lat: 47.31667 lon: 5.01667 facility: Research Site city: La Tronche zip: 38043 country: France lat: 45.20429 lon: 5.73645 facility: Research Site city: Le Coudray zip: 28630 country: France lat: 48.42115 lon: 1.50057 facility: Research Site city: Limoges zip: 87000 country: France lat: 45.83153 lon: 1.25781 facility: Research Site city: Montauban zip: 82017 country: France lat: 44.01667 lon: 1.35 facility: Research Site city: Montpellier Cedex zip: 34295 country: France lat: 43.61092 lon: 3.87723 facility: Research Site city: Nantes cedex 1 zip: 44093 country: France lat: 47.21725 lon: -1.55336 facility: Research Site city: Orleans zip: 45100 country: France lat: 47.90289 lon: 1.90389 facility: Research Site city: Paris zip: 75010 country: France lat: 48.85341 lon: 2.3488 facility: Research Site city: Paris zip: 75015 country: France lat: 48.85341 lon: 2.3488 facility: Research Site city: Poitiers zip: 86021 country: France lat: 46.58333 lon: 0.33333 facility: Research Site city: Reims zip: 51092 country: France lat: 49.25 lon: 4.03333 facility: Research Site city: Rennes Cedex 9 zip: 35033 country: France lat: 48.11198 lon: -1.67429 facility: Research Site city: Toulon zip: 83100 country: France lat: 43.12442 lon: 5.92836 facility: Research Site city: Toulouse zip: 31059 country: France lat: 43.60426 lon: 1.44367 facility: Research Site city: TOURS Cedex 9 zip: 37044 country: France lat: 47.38333 lon: 0.68333 facility: Research Site city: Valenciennes zip: 59300 country: France lat: 50.35 lon: 3.53333 facility: Research Site city: Bad Nauheim zip: 61231 country: Germany lat: 50.36463 lon: 8.73859 facility: Research Site city: Bechhofen zip: 66894 country: Germany lat: 49.35 lon: 7.4 facility: Research Site city: Bernau bei Berlin zip: 16321 country: Germany lat: 52.67982 lon: 13.58708 facility: Research Site city: Chemnitz zip: 9113 country: Germany lat: 50.8357 lon: 12.92922 facility: Research Site city: Coburg zip: 96450 country: Germany lat: 50.25937 lon: 10.96384 facility: Research Site city: Dresden zip: 1307 country: Germany lat: 51.05089 lon: 13.73832 facility: Research Site city: Elsterwerda zip: 04910 country: Germany lat: 51.46043 lon: 13.52001 facility: Research Site city: Frankfurt zip: 60590 country: Germany lat: 50.11552 lon: 8.68417 facility: Research Site city: Freiburg zip: 79106 country: Germany lat: 47.9959 lon: 7.85222 facility: Research Site city: Hagen zip: 58135 country: Germany lat: 51.36081 lon: 7.47168 facility: Research Site city: Hamburg zip: 20246 country: Germany lat: 53.57532 lon: 10.01534 facility: Research Site city: Hamburg zip: 22457 country: Germany lat: 53.57532 lon: 10.01534 facility: Research Site city: Kaiserslautern zip: 67655 country: Germany lat: 49.443 lon: 7.77161 facility: Research Site city: Köln zip: 50733 country: Germany lat: 50.93333 lon: 6.95 facility: Research Site city: Langen zip: 63225 country: Germany lat: 49.98955 lon: 8.66852 facility: Research Site city: Leipzig zip: 04103 country: Germany lat: 51.33962 lon: 12.37129 facility: Research Site city: Leverkusen zip: 51375 country: Germany lat: 51.0303 lon: 6.98432 facility: Research Site city: Mainz zip: 55131 country: Germany lat: 49.98419 lon: 8.2791 facility: Research Site city: Mönchengladbach zip: 41063 country: Germany lat: 51.18539 lon: 6.44172 facility: Research Site city: Papenburg zip: 26871 country: Germany lat: 53.07738 lon: 7.40444 facility: Research Site city: Regensburg zip: 93053 country: Germany lat: 49.01513 lon: 12.10161 facility: Research Site city: Remscheid zip: 42859 country: Germany lat: 51.17983 lon: 7.1925 facility: Research Site city: Rostock zip: 18059 country: Germany lat: 54.0887 lon: 12.14049 facility: Research Site city: Völklingen zip: 66333 country: Germany lat: 49.25162 lon: 6.85873 facility: Research Site city: Wermsdorf zip: 04779 country: Germany lat: 51.28333 lon: 12.95 facility: Research Site city: Witten zip: 58455 country: Germany lat: 51.44362 lon: 7.35258 facility: Research Site city: Athens zip: 11521 country: Greece lat: 37.97945 lon: 23.71622 facility: Research Site city: Athens zip: 11526 country: Greece lat: 37.97945 lon: 23.71622 facility: Research Site city: Athens zip: 11527 country: Greece lat: 37.97945 lon: 23.71622 facility: Research Site city: Athens zip: 12462 country: Greece lat: 37.97945 lon: 23.71622 facility: Research Site city: Athens zip: 14233 country: Greece lat: 37.97945 lon: 23.71622 facility: Research Site city: Athens zip: 15123 country: Greece lat: 37.97945 lon: 23.71622 facility: Research Site city: Dragana zip: 68100 country: Greece facility: Research Site city: Heraklio zip: 71110 country: Greece facility: Research Site city: Thessaloniki zip: 54636 country: Greece lat: 40.64361 lon: 22.93086 facility: Research Site city: Thessaloniki zip: 54642 country: Greece lat: 40.64361 lon: 22.93086 facility: Research Site city: Budapest zip: 1122 country: Hungary lat: 47.49801 lon: 19.03991 facility: Research Site city: Afula zip: 1834111 country: Israel lat: 32.60907 lon: 35.2892 facility: Research Site city: Ashkelon zip: 78278 country: Israel lat: 31.66926 lon: 34.57149 facility: Research Site city: Be'er Ya'akov zip: 70300 country: Israel facility: Research Site city: Beer Sheva zip: 8410101 country: Israel lat: 31.25181 lon: 34.7913 facility: Research Site city: Haifa zip: 3109601 country: Israel lat: 32.81841 lon: 34.9885 facility: Research Site city: Jerusalem zip: 00000 country: Israel lat: 31.76904 lon: 35.21633 facility: Research Site city: Kfar-Saba zip: 4428164 country: Israel lat: 32.175 lon: 34.90694 facility: Research Site city: Nahariya zip: 22100 country: Israel lat: 33.00892 lon: 35.09814 facility: Research Site city: Petah Tikva zip: 49372 country: Israel lat: 32.08707 lon: 34.88747 facility: Research Site city: Tiberias zip: 15208 country: Israel lat: 32.79221 lon: 35.53124 facility: Research Site city: Acquaviva delle Fonti zip: 70021 country: Italy lat: 40.89704 lon: 16.8433 facility: Research Site city: Bari zip: 70124 country: Italy lat: 41.11148 lon: 16.8554 facility: Research Site city: Bergamo zip: 24127 country: Italy lat: 45.69601 lon: 9.66721 facility: Research Site city: Brescia zip: 25100 country: Italy lat: 45.53558 lon: 10.21472 facility: Research Site city: Catanzaro zip: 88100 country: Italy lat: 38.88247 lon: 16.60086 facility: Research Site city: Cona zip: 44124 country: Italy lat: 44.80583 lon: 11.7069 facility: Research Site city: Cortona zip: 52044 country: Italy lat: 43.27467 lon: 11.98533 facility: Research Site city: Firenze zip: 50134 country: Italy lat: 43.77925 lon: 11.24626 facility: Research Site city: Milan zip: 20138 country: Italy lat: 45.46427 lon: 9.18951 facility: Research Site city: Novara zip: 28100 country: Italy lat: 45.44694 lon: 8.62118 facility: Research Site city: Pavia zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 facility: Research Site city: San Giovanni Rotondo zip: 71013 country: Italy lat: 41.70643 lon: 15.7277 facility: Research Site city: Fujisawa-shi zip: 251-8550 country: Japan lat: 35.34926 lon: 139.47666 facility: Research Site city: Fukutsu-shi zip: 811-3298 country: Japan lat: 33.783 lon: 130.49114 facility: Research Site city: Hakusan-shi zip: 924-8588 country: Japan facility: Research Site city: Himeji zip: 670-8560 country: Japan lat: 34.81667 lon: 134.7 facility: Research Site city: Iwakuni-shi zip: 740-8510 country: Japan lat: 34.16297 lon: 132.22 facility: Research Site city: Kawaguchi zip: 333-0842 country: Japan lat: 35.80521 lon: 139.71072 facility: Research Site city: Kobe-shi zip: 654-0155 country: Japan lat: 34.6913 lon: 135.183 facility: Research Site city: Matsumoto-shi zip: 390-8621 country: Japan lat: 36.23333 lon: 137.96667 facility: Research Site city: Moriyama-shi zip: 524-8524 country: Japan lat: 35.06667 lon: 135.98333 facility: Research Site city: Oita-shi zip: 870-8511 country: Japan lat: 33.23333 lon: 131.6 facility: Research Site city: Osaka-shi zip: 540-0006 country: Japan lat: 34.69374 lon: 135.50218 facility: Research Site city: Sagamihara-shi zip: 252-5188 country: Japan lat: 35.54899 lon: 139.26064 facility: Research Site city: Saitama shi zip: 336 8522 country: Japan lat: 35.90807 lon: 139.65657 facility: Research Site city: Sakai-shi zip: 599-8247 country: Japan lat: 34.58333 lon: 135.46667 facility: Research Site city: Sakata City zip: 998-8501 country: Japan lat: 38.91667 lon: 139.855 facility: Research Site city: Toshima-ku zip: 171-0014 country: Japan facility: Research Site city: Ueda-shi zip: 386-8610 country: Japan lat: 36.40265 lon: 138.28161 facility: Research Site city: Uji-shi zip: 611-0041 country: Japan lat: 34.89044 lon: 135.80325 facility: Research Site city: Uwajima-shi zip: 798-8510 country: Japan lat: 33.22375 lon: 132.56001 facility: Research Site city: Yokohama-shi zip: 221-0855 country: Japan lat: 35.43333 lon: 139.65 facility: Research Site city: Busan zip: 49241 country: Korea, Republic of lat: 35.10278 lon: 129.04028 facility: Research Site city: Seongnam-si zip: 13620 country: Korea, Republic of lat: 37.43861 lon: 127.13778 facility: Research Site city: Seoul zip: 03722 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Wonju-si zip: 26426 country: Korea, Republic of facility: Research Site city: Kajang zip: 43000 country: Malaysia lat: 2.99424 lon: 101.78875 facility: Research Site city: Kota Kinabalu zip: 88300 country: Malaysia lat: 5.9749 lon: 116.0724 facility: Research Site city: Kota Samarahan zip: 94300 country: Malaysia facility: Research Site city: Kuala Lumpur zip: 50400 country: Malaysia lat: 3.1412 lon: 101.68653 facility: Research Site city: Kuala Terengganu zip: 20400 country: Malaysia lat: 5.3302 lon: 103.1408 facility: Research Site city: Kuantan zip: 25200 country: Malaysia lat: 3.8077 lon: 103.326 facility: Research Site city: Sungai Buloh zip: 47000 country: Malaysia lat: 3.2 lon: 101.58333 facility: Research Site city: Aguascalientes zip: 20230 country: Mexico lat: 21.88234 lon: -102.28259 facility: Research Site city: Cuauhtémoc zip: 06700 country: Mexico lat: 19.44506 lon: -99.14612 facility: Research Site city: Culiacán zip: 80200 country: Mexico lat: 24.79032 lon: -107.38782 facility: Research Site city: Guadalajara zip: 44670 country: Mexico lat: 20.66682 lon: -103.39182 facility: Research Site city: Mazatlán zip: 82110 country: Mexico lat: 23.2329 lon: -106.4062 facility: Research Site city: Metepec zip: 52170 country: Mexico lat: 19.25934 lon: -99.60175 facility: Research Site city: Mexico City zip: 03310 country: Mexico lat: 19.42847 lon: -99.12766 facility: Research Site city: Mexico City zip: 07300 country: Mexico lat: 19.42847 lon: -99.12766 facility: Research Site city: Mexico zip: 14080 country: Mexico lat: 19.42847 lon: -99.12766 facility: Research Site city: Monterey zip: 64060 country: Mexico facility: Research Site city: Morelia zip: 58260 country: Mexico lat: 19.70078 lon: -101.18443 facility: Research Site city: México zip: 11650 country: Mexico lat: 19.42847 lon: -99.12766 facility: Research Site city: Querétaro zip: 76000 country: Mexico facility: Research Site city: San Luis Potosí zip: 78250 country: Mexico lat: 22.14982 lon: -100.97916 facility: Research Site city: Tijuana zip: 22014 country: Mexico lat: 32.5027 lon: -117.00371 facility: Research Site city: Veracruz zip: 91910 country: Mexico lat: 19.18095 lon: -96.1429 facility: Research Site city: Xalapa zip: 91193 country: Mexico lat: 19.53124 lon: -96.91589 facility: Research Site city: Arnhem zip: 6815 AD country: Netherlands lat: 51.98 lon: 5.91111 facility: Research Site city: Emmen zip: 7824 AA country: Netherlands lat: 52.77917 lon: 6.90694 facility: Research Site city: Goes zip: 4462 RA country: Netherlands lat: 51.50417 lon: 3.88889 facility: Research Site city: Groningen zip: 9728 NT country: Netherlands lat: 53.21917 lon: 6.56667 facility: Research Site city: Hardenberg zip: 7772 SE country: Netherlands lat: 52.57583 lon: 6.61944 facility: Research Site city: Bellavista zip: CALLAO 2 country: Peru lat: -7.05614 lon: -76.5911 facility: Research Site city: Lima zip: 15024 country: Peru lat: -12.04318 lon: -77.02824 facility: Research Site city: Lima zip: 15046 country: Peru lat: -12.04318 lon: -77.02824 facility: Research Site city: Lima zip: 15072 country: Peru lat: -12.04318 lon: -77.02824 facility: Research Site city: Lima zip: 15088 country: Peru lat: -12.04318 lon: -77.02824 facility: Research Site city: Lima zip: 15131 country: Peru lat: -12.04318 lon: -77.02824 facility: Research Site city: Lima zip: L18 country: Peru lat: -12.04318 lon: -77.02824 facility: Research Site city: Lima zip: LIMA 11 country: Peru lat: -12.04318 lon: -77.02824 facility: Research Site city: Lima zip: LIMA 27 country: Peru lat: -12.04318 lon: -77.02824 facility: Research Site city: Lima zip: LIMA 41 country: Peru lat: -12.04318 lon: -77.02824 facility: Research Site city: Piura zip: 20001 country: Peru lat: -5.19449 lon: -80.63282 facility: Research Site city: Angeles City zip: 2009 country: Philippines lat: 15.15 lon: 120.58333 facility: Research Site city: Davao City zip: 8000 country: Philippines lat: 7.07306 lon: 125.61278 facility: Research Site city: Davao City zip: PH-8000 country: Philippines lat: 7.07306 lon: 125.61278 facility: Research Site city: Iloilo City zip: 5000 country: Philippines lat: 10.69694 lon: 122.56444 facility: Research Site city: Las Pinas City zip: PH-1704 country: Philippines facility: Research Site city: Mabalacat zip: 2023 country: Philippines lat: 15.22303 lon: 120.57117 facility: Research Site city: Manadaluyong City zip: 1552 country: Philippines facility: Research Site city: Manila zip: 1008 country: Philippines lat: 14.6042 lon: 120.9822 facility: Research Site city: Marikina zip: 1800 country: Philippines facility: Research Site city: Pasig City zip: 1605 country: Philippines lat: 14.58691 lon: 121.0614 facility: Research Site city: Quezon City zip: 1101 country: Philippines lat: 14.6488 lon: 121.0509 facility: Research Site city: Quezon City zip: 1112 country: Philippines lat: 14.6488 lon: 121.0509 facility: Research Site city: Taguig City zip: 1634 country: Philippines facility: Research Site city: West San Juan City zip: 1502 country: Philippines facility: Research Site city: Biała Podlaska zip: 21-500 country: Poland lat: 52.03238 lon: 23.11652 facility: Research Site city: Białystok zip: 15-481 country: Poland lat: 53.13333 lon: 23.16433 facility: Research Site city: Bielsko-Biała zip: 43-316 country: Poland lat: 49.82245 lon: 19.04686 facility: Research Site city: Bydgoszcz zip: 85-605 country: Poland lat: 53.1235 lon: 18.00762 facility: Research Site city: Bydgoszcz zip: 85-794 country: Poland lat: 53.1235 lon: 18.00762 facility: Research Site city: Chrzanów zip: 32-500 country: Poland lat: 50.13546 lon: 19.40203 facility: Research Site city: Gdynia zip: 81-157 country: Poland lat: 54.51889 lon: 18.53188 facility: Research Site city: Kazimierza Wielka zip: 28-500 country: Poland lat: 50.26564 lon: 20.49358 facility: Research Site city: Kraków zip: 30-082 country: Poland lat: 50.06143 lon: 19.93658 facility: Research Site city: Kraków zip: 30-688 country: Poland lat: 50.06143 lon: 19.93658 facility: Research Site city: Kraków zip: 31-513 country: Poland lat: 50.06143 lon: 19.93658 facility: Research Site city: Kędzierzyn-Koźle zip: 47-200 country: Poland lat: 50.34984 lon: 18.22606 facility: Research Site city: Lublin zip: 20-044 country: Poland lat: 51.25 lon: 22.56667 facility: Research Site city: Lublin zip: 20-857 country: Poland lat: 51.25 lon: 22.56667 facility: Research Site city: Olsztyn zip: 10-010 country: Poland lat: 53.77995 lon: 20.49416 facility: Research Site city: Piekary Śląskie zip: 41-940 country: Poland lat: 50.38017 lon: 18.92653 facility: Research Site city: Poznań zip: 61- 848 country: Poland lat: 52.40692 lon: 16.92993 facility: Research Site city: Rzeszow zip: 35-055 country: Poland lat: 50.04132 lon: 21.99901 facility: Research Site city: Rzeszów zip: 35-205 country: Poland lat: 50.04132 lon: 21.99901 facility: Research Site city: Szczecin zip: 71-526 country: Poland lat: 53.42894 lon: 14.55302 facility: Research Site city: Tarnów zip: 33-100 country: Poland lat: 50.01381 lon: 20.98698 facility: Research Site city: Toruń zip: 87-100 country: Poland lat: 53.01375 lon: 18.59814 facility: Research Site city: Tychy zip: 43-100 country: Poland lat: 50.13717 lon: 18.96641 facility: Research Site city: Warszawa zip: 00-416 country: Poland lat: 52.22977 lon: 21.01178 facility: Research Site city: Warszawa zip: 04-501 country: Poland lat: 52.22977 lon: 21.01178 facility: Research Site city: Zabrze zip: 41-800 country: Poland lat: 50.32492 lon: 18.78576 facility: Research Site city: Łódź zip: 90-549 country: Poland lat: 51.75 lon: 19.46667 facility: Research Site city: Łódź zip: 91-053 country: Poland lat: 51.75 lon: 19.46667 facility: Research Site city: Łódź zip: 93-513 country: Poland lat: 51.75 lon: 19.46667 facility: Research Site city: Łódź zip: 94-046 country: Poland lat: 51.75 lon: 19.46667 facility: Research Site city: Bucharest zip: 014461 country: Romania lat: 44.43225 lon: 26.10626 facility: Research Site city: Bucharest zip: 040883 country: Romania lat: 44.43225 lon: 26.10626 facility: Research Site city: Bucuresti zip: 022328 country: Romania lat: 44.42802 lon: 26.09665 facility: Research Site city: Cluj-Napoca zip: 400437 country: Romania lat: 46.76667 lon: 23.6 facility: Research Site city: Iasi zip: 700503 country: Romania lat: 47.16667 lon: 27.6 facility: Research Site city: Targu Mures zip: 540099 country: Romania lat: 46.54245 lon: 24.55747 facility: Research Site city: Targu Mures zip: 540136 country: Romania lat: 46.54245 lon: 24.55747 facility: Research Site city: Timisoara zip: 300595 country: Romania lat: 45.75372 lon: 21.22571 facility: Research Site city: Timișoara zip: 300310 country: Romania lat: 45.75372 lon: 21.22571 facility: Research Site city: Bratislava zip: 831 01 country: Slovakia lat: 48.14816 lon: 17.10674 facility: Research Site city: Brezno zip: 977 01 country: Slovakia lat: 48.80431 lon: 19.63631 facility: Research Site city: Kosice zip: 04022 country: Slovakia lat: 48.71395 lon: 21.25808 facility: Research Site city: Martin zip: 036 01 country: Slovakia lat: 49.06651 lon: 18.92399 facility: Research Site city: Myjava zip: 90701 country: Slovakia lat: 48.75876 lon: 17.56866 facility: Research Site city: Nitra zip: 949 01 country: Slovakia lat: 48.30763 lon: 18.08453 facility: Research Site city: Nove Zamky zip: 940 01 country: Slovakia lat: 47.98544 lon: 18.16195 facility: Research Site city: Považská Bystrica zip: 017 01 country: Slovakia lat: 49.12153 lon: 18.42169 facility: Research Site city: Presov zip: 080 01 country: Slovakia lat: 48.99839 lon: 21.23393 facility: Research Site city: Prešov zip: 080 01 country: Slovakia lat: 48.99839 lon: 21.23393 facility: Research Site city: Rimavska Sobota zip: 979 01 country: Slovakia lat: 48.38284 lon: 20.02239 facility: Research Site city: Svidník zip: 08901 country: Slovakia lat: 49.30819 lon: 21.5703 facility: Research Site city: A Coruña zip: 15006 country: Spain lat: 43.37135 lon: -8.396 facility: Research Site city: Barcelona zip: 08025 country: Spain lat: 41.38879 lon: 2.15899 facility: Research Site city: Barcelona zip: 08035 country: Spain lat: 41.38879 lon: 2.15899 facility: Research Site city: Barcelona zip: 08036 country: Spain lat: 41.38879 lon: 2.15899 facility: Research Site city: Lugo zip: 27004 country: Spain lat: 43.00992 lon: -7.55602 facility: Research Site city: Madrid zip: 28007 country: Spain lat: 40.4165 lon: -3.70256 facility: Research Site city: Madrid zip: 28027 country: Spain lat: 40.4165 lon: -3.70256 facility: Research Site city: Majadahonda zip: 28222 country: Spain lat: 40.47353 lon: -3.87182 facility: Research Site city: Sevilla zip: 41009 country: Spain lat: 37.38283 lon: -5.97317 facility: Research Site city: Sevilla zip: 41014 country: Spain lat: 37.38283 lon: -5.97317 facility: Research Site city: Alingsås zip: 441 83 country: Sweden lat: 57.93033 lon: 12.53345 facility: Research Site city: Göteborg zip: 413 46 country: Sweden lat: 57.70716 lon: 11.96679 facility: Research Site city: Helsingborg zip: 252 23 country: Sweden lat: 56.04673 lon: 12.69437 facility: Research Site city: Jönköping zip: 551 85 country: Sweden lat: 57.78145 lon: 14.15618 facility: Research Site city: Karlstad zip: 651 85 country: Sweden lat: 59.3793 lon: 13.50357 facility: Research Site city: Lund zip: 22242 country: Sweden lat: 55.70584 lon: 13.19321 facility: Research Site city: Stockholm zip: 118 83 country: Sweden lat: 59.33258 lon: 18.0649 facility: Research Site city: Stockholm zip: 171 64 country: Sweden lat: 59.33258 lon: 18.0649 facility: Research Site city: Uppsala zip: 75185 country: Sweden lat: 59.85882 lon: 17.63889 facility: Research Site city: Västerås zip: 723 35 country: Sweden lat: 59.61617 lon: 16.55276 facility: Research Site city: Changhua zip: 500 country: Taiwan lat: 24.07327 lon: 120.56276 facility: Research Site city: Kaohsiung zip: 80756 country: Taiwan lat: 22.61626 lon: 120.31333 facility: Research Site city: Kaohsiung zip: 81362 country: Taiwan lat: 22.61626 lon: 120.31333 facility: Research Site city: New Taipei City zip: 25160 country: Taiwan lat: 25.01111 lon: 121.44583 facility: Research Site city: New Taipei zip: 220 country: Taiwan lat: 25.01111 lon: 121.44583 facility: Research Site city: New Taipei zip: 231 country: Taiwan lat: 25.01111 lon: 121.44583 facility: Research Site city: Taichung zip: 40447 country: Taiwan lat: 24.1469 lon: 120.6839 facility: Research Site city: Taichung zip: 433 country: Taiwan lat: 24.1469 lon: 120.6839 facility: Research Site city: Taipei City zip: 110 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taipei zip: 0116 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taipei zip: 10002 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taipei zip: 10449 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taipei zip: 11101 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taipei zip: 11217 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taipei zip: TAIWAN country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taoyuan zip: 333 country: Taiwan lat: 24.95233 lon: 121.20193 facility: Research Site city: Yilan zip: 260 country: Taiwan lat: 24.757 lon: 121.753 facility: Research Site city: Yung Kang City zip: 71044 country: Taiwan facility: Research Site city: Bangkok zip: 10330 country: Thailand lat: 13.75398 lon: 100.50144 facility: Research Site city: Bangkok zip: 10400 country: Thailand lat: 13.75398 lon: 100.50144 facility: Research Site city: Chiang Mai zip: 50200 country: Thailand lat: 18.79038 lon: 98.98468 facility: Research Site city: Hat Yai zip: 90110 country: Thailand lat: 7.00836 lon: 100.47668 facility: Research Site city: Khon Kaen zip: 40002 country: Thailand lat: 16.44671 lon: 102.833 facility: Research Site city: Naimuang zip: 30000 country: Thailand facility: Research Site city: Pathumthani zip: 12120 country: Thailand lat: 14.01346 lon: 100.53049 facility: Research Site city: Adana zip: 01060 country: Turkey lat: 37.00167 lon: 35.32889 facility: Research Site city: Ankara zip: 06 country: Turkey lat: 39.91987 lon: 32.85427 facility: Research Site city: Antalya zip: 07059 country: Turkey lat: 36.90812 lon: 30.69556 facility: Research Site city: Antalya zip: 07100 country: Turkey lat: 36.90812 lon: 30.69556 facility: Research Site city: Dinar zip: 03400 country: Turkey lat: 38.065 lon: 30.16557 facility: Research Site city: Eskisehir zip: 26480 country: Turkey lat: 39.77667 lon: 30.52056 facility: Research Site city: Istanbul zip: 34668 country: Turkey lat: 41.01384 lon: 28.94966 facility: Research Site city: Izmir zip: 35340 country: Turkey lat: 38.41273 lon: 27.13838 facility: Research Site city: Kocaeli zip: 41380 country: Turkey lat: 39.62497 lon: 27.51145 facility: Research Site city: Kütahya zip: 43100 country: Turkey lat: 39.42417 lon: 29.98333 facility: Research Site city: Merkez zip: 78200 country: Turkey facility: Research Site city: Mugla zip: 48000 country: Turkey lat: 37.21807 lon: 28.3665 facility: Research Site city: Sivas zip: 58140 country: Turkey lat: 39.74833 lon: 37.01611 facility: Research Site city: Airdrie zip: ML6 0JS country: United Kingdom lat: 55.86602 lon: -3.98025 facility: Research Site city: Barnet zip: EN5 3DJ country: United Kingdom lat: 51.65 lon: -0.2 facility: Research Site city: Cambridge zip: CB2 0AY country: United Kingdom lat: 52.2 lon: 0.11667 facility: Research Site city: Chertsey zip: KT16 0PZ country: United Kingdom lat: 51.38812 lon: -0.50782 facility: Research Site city: Clydebank zip: G81 4DY country: United Kingdom lat: 55.90137 lon: -4.4057 facility: Research Site city: Exeter zip: EX2 5DW country: United Kingdom lat: 50.7236 lon: -3.52751 facility: Research Site city: Harefield zip: UB9 6JH country: United Kingdom lat: 51.60333 lon: -0.48546 facility: Research Site city: Hastings zip: TN37 7RD country: United Kingdom lat: 50.85519 lon: 0.57292 facility: Research Site city: High Wycombe zip: HP11 2TT country: United Kingdom lat: 51.62907 lon: -0.74934 facility: Research Site city: King's Lynn zip: PE30 4ET country: United Kingdom lat: 52.75172 lon: 0.39516 facility: Research Site city: Lincoln zip: LN2 5QY country: United Kingdom lat: 53.22683 lon: -0.53792 facility: Research Site city: London zip: EC1A 7BE country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site city: London zip: SE5 9RS country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site city: Middlesborough zip: TS4 3BW country: United Kingdom lat: 54.57623 lon: -1.23483 facility: Research Site city: Portsmouth zip: PO6 3LY country: United Kingdom lat: 50.79899 lon: -1.09125 facility: Research Site city: Sheffield zip: S5 7AU country: United Kingdom lat: 53.38297 lon: -1.4659 facility: Research Site city: Sunderland zip: SR4 7TP country: United Kingdom lat: 54.90465 lon: -1.38222 facility: Research Site city: Wakefield zip: WF1 4DG country: United Kingdom lat: 53.68331 lon: -1.49768 facility: Research Site city: Da Nang zip: 550000 country: Vietnam lat: 16.06778 lon: 108.22083 facility: Research Site city: Hai Phong zip: 180000 country: Vietnam lat: 20.86481 lon: 106.68345 facility: Research Site city: Hanoi zip: 100000 country: Vietnam lat: 21.0245 lon: 105.84117 facility: Research Site city: Ho Chi Minh zip: 700000 country: Vietnam lat: 10.82302 lon: 106.62965 facility: Research Site city: Hochiminh city zip: 700000 country: Vietnam lat: 10.82302 lon: 106.62965 hasResults: False

 nctId: NCT06307639 id: MYMSwifee briefTitle: Seminal Levels of PGK2 and ACRV1 as Predictors of Micro-TESE Results in NOA overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-10-01 date: 2026-04-01 date: 2024-03-13 date: 2024-03-13 name: Assiut University class: OTHER briefSummary: * Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE).
* Correlate seminal levels of PGK2 and ACRV1 with sperm retrieval results and histopathology analysis of testicular biopsy samples. conditions: Male Infertility Due to Azoospermia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 64 type: ESTIMATED name: Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE). measure: Know more about the functional role of PGK2 and ACRV1 in the process of spermatogenesis. measure: Detect if PGK2 and/or AVRV1 level can used as predictor for spermatogenesis in infertile men with non-obstructive azoospermia undergoing Testicular Sperm Extraction. sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06307626 id: ARGX-113-2309 id: 2023-509198-22-00 type: CTIS briefTitle: A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease. overallStatus: RECRUITING date: 2024-03-28 date: 2026-02 date: 2027-10 date: 2024-03-13 date: 2024-04-04 name: argenx class: INDUSTRY briefSummary: This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC.

After an up to 28-day screening period, eligible participants will be randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively. Study drug will be administered subcutaneously during the 24-week double-blinded treatment period (DBTP). At the end of the DBTP (week 24), proptosis responders will enter a follow-up observational period (52 weeks) to assess the safety, tolerability, and durability of efgartigimod PH20 SC treatment while off therapy. Proptosis nonresponders and participants who have proptosis relapse during the 52-week follow-up observational period will receive open-label treatment with efgartigimod PH20 SC for up to 24 weeks. conditions: Thyroid Eye Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 108 type: ESTIMATED name: Efgartigimod PH20 SC name: Placebo PH20 SC measure: Percentage of participants who were proptosis responders measure: Change in proptosis measurement in the study eye from baseline measure: Change in the total Graves' Orbitopathy Quality of Life (GO-QoL) score from baseline measure: Percentage of participants with a resolution of diplopia (responders) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Advanced Research status: RECRUITING city: Boynton Beach state: Florida zip: 33437 country: United States name: Sirtaz S. Sibia, MD role: CONTACT phone: 857-350-4834 email: clinicaltrials@argenx.com lat: 26.52535 lon: -80.06643 hasResults: False

 nctId: NCT06307613 id: ARGX-113-2301 id: 2023-509197-35-00 type: CTIS briefTitle: A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease overallStatus: RECRUITING date: 2024-03-27 date: 2026-02 date: 2027-10 date: 2024-03-13 date: 2024-04-04 name: argenx class: INDUSTRY briefSummary: This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC.

After an up to 28-day screening period, eligible participants will be randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively. Study drug will be administered subcutaneously during the 24-week double-blinded treatment period (DBTP). At the end of the DBTP (week 24), proptosis responders will enter a follow-up observational period (52 weeks) to assess the safety, tolerability, and durability of efgartigimod PH20 SC treatment while off therapy. Proptosis nonresponders and participants who have proptosis relapse during the 52-week follow-up observational period will receive open-label treatment with efgartigimod PH20 SC for up to 24 weeks. conditions: Thyroid Eye Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 108 type: ESTIMATED name: Efgartigimod PH20 SC name: Placebo PH20 SC measure: Percentage of participants who were proptosis responders measure: Change in proptosis measurement in the study eye from baseline measure: Change in the total Graves' Orbitopathy Quality of Life (GO-QoL) score from baseline measure: Percentage of participants with a resolution of diplopia (responders) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Advanced Clinical Research status: RECRUITING city: Coral Springs state: Florida zip: 33067 country: United States name: Shailesh Gupta, MD role: CONTACT phone: 857-350-4834 email: clinicaltrials@argenx.com lat: 26.27119 lon: -80.2706 hasResults: False

 nctId: NCT06307600 id: BHCT-RD06-03 briefTitle: The Safety and Efficacy of RD06-03 CART Cell Injection in Patients With R/R Acute B-lymphoblastic Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-03-15 date: 2027-04-01 date: 2024-03-13 date: 2024-03-13 name: Anhui Provincial Hospital class: OTHER_GOV briefSummary: This study is designed to explore the safety and efficacy for patients with relapsed and/or refractory B-cell lymphoblastic leukemia. conditions: B Lymphoblastic Leukemia/Lymphoma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 9 type: ESTIMATED name: RD06-03 cell injection measure: Dose-limiting toxicity sex: ALL minimumAge: 3 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Provincial Hospital city: Hefei state: Anhui zip: 230036 country: China lat: 31.86389 lon: 117.28083 hasResults: False

 nctId: NCT06307587 id: 2023/2355 briefTitle: Vastus Intermedius Dry Needling for Knee Stiffness Resulted From Surgically Managed Femoral Fractures With Open Reduction & Internal Fixation. overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-03-01 date: 2027-03-12 date: 2024-03-13 date: 2024-03-13 name: Al-Razi Hospital class: OTHER_GOV briefSummary: Orthopedic traumatic injuries are considered a major health epidemic, challenged by high morbidity, mortality, and socioeconomic burden. The management of traumatic orthopedic injuries is challenging and complex, with high resources utilization. Particularly, the prevalence of femoral fractures in Kuwait is 8.8%, being one of the most prevalent injuries. Open reduction and internal fixation (ORIF) is a common surgical procedure for the management of femoral fractures demonstrating successful outcome for allowing minimally invasive percutaneous plate osteosynthesis, early union of 93% to 100%, and low infection rate of only 0% to 2%. Yet, one of the major complications post ORIF is knee stiffness and reduced function, which brings many inconveniences to patients' daily lives, lead to disability, and could seriously threaten the functional activities of patients. The incidence of knee stiffness requiring surgical intervention is 14.5%. Particularly, the potential loss of knee flexion is 30 to 40 degrees, 13% of the patients failed to reach 90 degrees of knee flexion, and only 48% of patients reached \>120 degrees of flexion. Ultimately, knee stiffness in flexion forms a major issue in distal femoral fractures. Various reasons could explain such complication including intrinsic adhesions, fibrosis and shortening of the vastus intermedius muscle.

There are various surgical procedures which could be used to manage knee stiffness. However, there is no consensus regarding the ideal approach and strategy with many postoperative complications including deep sepsis, quadricep tendon rupture, skin dehiscence and infection, delayed wound healing, patella fracture, lateral femoral condyle fracture and extension lag. In contrast, dry needling (DN) is a minimal invasive intervention for the management of musculoskeletal dysfunction, and it could be used to reduce the adhesion and fibrosis between the vastus intermedius and the femoral bone. However, there is limited research investigating the effect of DN on the vastus intermedius muscle after ORIF of the femoral fractures. The effectiveness of DN was explored for the management of various musculoskeletal conditions, and a systematic review addressing DN in the lower quarter concluded that DN is an effective procedure (Morihisa et a,., 2016). In ACL reconstruction, DN for the vastus medialis improved ROM at short-term and improved function at both short and long term. DN has been proposed as a useful addition to the rehabilitation of ACL reconstructed in reducing pain intensity, increasing knee flexion range, and modifying the mechanical properties of the quadriceps muscle during the late-stage of rehabilitation. DN has also altered the passive mechanical properties of the quadriceps muscle where decrement and resistance of the vastus medialis were significantly reduced. It is hypothesized that releasing the adhesions and fibrosis of the vastus intermedius could play an important role in managing knee stiffness post ORIF of the distal femur fractures. Therefore, the aim of this project is to identify the incidence rate and risk factors of knee stiffness resulted from surgically managed femoral fractures with open reduction and internal fixation in Kuwait, and to investigate the effect of DN on the vastus intermedius muscle in improving knee joint range of motion and function after ORIF of the distal femur using single blind randomized controlled trial (RCT). conditions: Femur Fracture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: dry needling measure: knee flexion range of motion sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06307574 id: STUDY00002804 briefTitle: bpMedManage: Digital Technology to Support Adherence to Hypertension Medications overallStatus: RECRUITING date: 2024-02-29 date: 2025-05 date: 2025-12 date: 2024-03-13 date: 2024-04-01 name: University of Arizona class: OTHER name: University of Illinois at Urbana-Champaign briefSummary: The purpose of the bpMedManage study is to rigorously test the efficacy of a smartphone technology to help improve high blood pressure medication adherence among older adults with mild cognitive impairment (MCI) in a 16-week randomized controlled trial. A total of 100 older adults will be recruited. There will be two treatment arms, bpMedManage-S and bpMedManage-P with 50 participants in each arm. Participants randomized into the bpMEDManage-S intervention arm will use a smartphone application with medication reminders plus receive education with standardized information on hypertension and antihypertensive medications on the education portal. Participants in the bpMedManage-P group will use a smartphone to receive education with standardized information on hypertension and antihypertensive medications on an education portal. Both groups will complete baseline assessments followed by 4 weeks of medication adherence monitoring. At the end of the adherence monitoring period, participants will be randomized into one of the two treatment arms. Immediate outcomes on primary and secondary measures will be assessed 4 weeks after beginning of the intervention. Follow-up outcomes will be assessed 12 weeks after the beginning of the intervention. conditions: Aging conditions: Mild Cognitive Impairment conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be screened and randomly assigned to either the bpMedManage-S or bpMedManage-P group primaryPurpose: OTHER masking: SINGLE maskingDescription: All primary and secondary outcome assessments following the intervention, Week 4, are blinded. One of the supplementary outcome measures following the intervention at Week 12, requires the assessor to know the group assignment. This outcome pertains to their experience in the intervention. The follow-up outcome assessments at Week 12 will be administered by an unblinded assessor. whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: bpMedManage measure: Change in medication adherence measured by the Medication Event Monitoring System (MEMS® Cap) measure: Change in self-reported medication adherence measured by the Medication Adherence Report Scale-5 (MARS-5© Professor Rob Horne) measure: Change in Systolic and/or Diastolic blood pressure, as measured by taking blood pressure readings measure: Change in hypertension knowledge measured by the Hypertension Knowledge-Level Scale measure: System Usability measured by the System Usability Scale measure: Opinion Interview sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Arizona status: RECRUITING city: Tucson state: Arizona zip: 85721 country: United States name: Kathleen Insel, PhD role: CONTACT phone: 520-626-6220 email: insel@arizona.edu lat: 32.22174 lon: -110.92648 facility: University of Illinois, Urbana-Champaign status: NOT_YET_RECRUITING city: Champaign state: Illinois zip: 61820 country: United States name: Raksha Mudar, PhD role: CONTACT phone: 217-333-4718 email: raksha@illinois.edu lat: 40.11642 lon: -88.24338 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-02-21 uploadDate: 2024-02-21T16:53 filename: Prot_000.pdf size: 560648 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-11-04 uploadDate: 2024-03-08T14:33 filename: ICF_001.pdf size: 563829 hasResults: False

 nctId: NCT06307561 id: GGurzoglu briefTitle: The Effect of Dystonia Severity on Participation in Daily Living Activities and Caregivers in Children of Cerebral Palsy With Secondary Dystonia overallStatus: COMPLETED date: 2021-01-01 date: 2024-01-01 date: 2024-01-01 date: 2024-03-13 date: 2024-03-13 name: Acıbadem Atunizade Hospital class: OTHER briefSummary: Dystonia is the most common movement disorder in the pediatric population after spasticity. It can affect normal motor development and cause significant motor retardation. The presence of dystonia may affect motor function, pain, and ease of care in CP. Additionally, it can cause serious difficulties in daily living activities and social participation and long-term joint deformity. The increase in the severity of dystonia in CP children with secondary dystonia may affect the quality of life, activity and participation of the children, as well as the caregiver. The importance of caregivers is an undeniable fact, especially in these patient groups. This study aims to investigate the burden of dystonia severity on the participation in daily living activities and caregivers of children with CP with secondary dystonia. conditions: Secondary Dystonia conditions: Cerebral Palsy, Mixed studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 20 type: ACTUAL measure: The Barry-Albright Dystonia Scale (BADS) measure: The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) measure: The Care and Comfort Hypertonicity Questionnaire (CCHQ) sex: ALL minimumAge: 3 Years maximumAge: 15 Years stdAges: CHILD facility: Acıbadem Altunizade Hospital city: Istanbul state: Altunizade zip: 34662 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06307548 id: I-3670923 id: NCI-2024-01256 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: I-3670923 type: OTHER domain: Roswell Park Cancer Institute id: UL1TR001412 type: NIH link: https://reporter.nih.gov/quickSearch/UL1TR001412 briefTitle: Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-06-01 date: 2027-06-01 date: 2024-03-13 date: 2024-04-24 name: Roswell Park Cancer Institute class: OTHER name: National Center for Advancing Translational Sciences (NCATS) briefSummary: This phase I/II trial studies the side effects and how well fluorescence image guided surgery followed by intraoperative photodynamic therapy for improving local tumor control in patients with colorectal cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has come back after a period of improvement (recurrent). Fluorescence image guided surgery uses a drug named aminolevulinic acid hydrochloride. Aminolevulinic acid hydrochloride is a photosensitizing agent, meaning that is activated by light and, is converted to another drug in cancer cells more than in normal cells. The converted drug emits fluorescence red light when activated with low power blue light. It is used to assist the surgeon to see cancer cells and small cancerous tissue that may have been missed during routine surgery. In addition to emitting fluorescence light, the converted drug in the cancer cells and tissue can be activated with red laser light to kill cancer cells. This procedure is called photodynamic therapy (PDT). Performing fluorescence image guided surgery followed by intraoperative photodynamic therapy after the surgical removal of the colorectal tumor before the surgical site will be closed may be effective and improve outcomes in patients with locally advanced or recurrent colorectal cancer. conditions: Locally Advanced Colorectal Carcinoma conditions: Recurrent Colorectal Carcinoma conditions: Stage III Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: Aminolevulinic Acid name: Biospecimen Collection name: Computed Tomography name: Fluorescence-Guided Surgery name: Magnetic Resonance Imaging name: Photodynamic Therapy name: Surgical Procedure measure: Accuracy of the fluorescence imaging (Phase I) measure: Incidence of adverse events (Phase I) measure: Evidence of disease (Phase II) measure: Changes in carcinoembryonic antigen (CEA) and circulating tumor deoxyribonucleic acid (ctDNA) (Phase II) measure: Changes in CEA and ctDNA (Phase I) measure: Rate of recurrence (Phase I) measure: Rate of local recurrence (Phase II) measure: Disease free survival (Phase II) measure: Correlation between disease free survival and changes in levels of CEA (Phase II) measure: Correlation between disease free survival and changes in levels of ctDNA (Phase II) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Roswell Park Cancer Institute city: Buffalo state: New York zip: 14263 country: United States name: Anthony S. Dakwar role: CONTACT phone: 716-845-5807 email: Anthony.Dakwar@RoswellPark.org name: Anthony S. Dakwar role: PRINCIPAL_INVESTIGATOR lat: 42.88645 lon: -78.87837 hasResults: False

 nctId: NCT06307535 id: 23-376 briefTitle: A Study of Meaning-Centered Psychotherapy for Caregivers to People With Cancer overallStatus: RECRUITING date: 2024-02-29 date: 2029-03-01 date: 2029-03-01 date: 2024-03-13 date: 2024-04-11 name: Memorial Sloan Kettering Cancer Center class: OTHER briefSummary: Participants will complete 1 set of questionnaires about 2 weeks before beginning their Meaning-Centered Psychotherapy for Caregivers/MCP-C or standard Supportive Psychotherapy for Caregivers/SP-C sessions. These questionnaires will ask about participants' sense of meaning and purpose in life, spiritual well-being, depression and/or anxiety, and social support. Participants will then be assigned to receive either MCP-C or SP-C for 7 sessions. Participants will complete additional sets of questionnaires about 2 weeks, 6 months, and 12 months after their last session of MCP-C or SP-C. It will take between 35 and 50 minutes to complete each set of questionnaires.

After participants complete the MCP-C or SP-C sessions and all 4 sets of questionnaires, their participation in this study will end. If participants decide not to complete all 7 sessions, they may still choose to complete the questionnaires.

Participants may remain in the study and continue to receive all 7 sessions of MCP-C or SP-C even if their loved one passes away. conditions: Caregiver Burden conditions: Caregiver Burnout conditions: Caregiver Stress Syndrome studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 200 type: ESTIMATED name: Meaning-Centered Psychotherapy for Caregivers name: Supportive Psychotherapy for Caregivers measure: Number of participants with improved primary outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami (Data Collection AND Data Analysis) status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33136 country: United States name: Wendy Lichtenthal, PhD role: CONTACT phone: 305-243-8983 lat: 25.77427 lon: -80.19366 facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) status: RECRUITING city: Basking Ridge state: New Jersey zip: 07920 country: United States name: Allison Applebaum, PhD role: CONTACT phone: 646-888-0034 lat: 40.70621 lon: -74.54932 facility: Memorial Sloan Kettering Monmouth (Limited protocol activities) status: RECRUITING city: Middletown state: New Jersey zip: 07748 country: United States name: Allison Applebaum, PhD role: CONTACT phone: 646-888-0034 lat: 40.39652 lon: -74.09211 facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities) status: RECRUITING city: Montvale state: New Jersey zip: 07645 country: United States name: Allison Applebaum, PhD role: CONTACT phone: 646-888-0034 lat: 41.04676 lon: -74.02292 facility: Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) status: RECRUITING city: Commack state: New York zip: 11725 country: United States name: Allison Applebaum, PhD role: CONTACT phone: 646-888-0034 lat: 40.84288 lon: -73.29289 facility: Memorial Sloan Kettering Westchester (Consent only) status: RECRUITING city: Harrison state: New York zip: 10604 country: United States name: Allison Applebaum, PhD role: CONTACT phone: 646-888-0034 lat: 40.96899 lon: -73.71263 facility: Memorial Sloan Kettering Cancer Center status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Allison Applebaum, PhD role: CONTACT phone: 646-888-0034 lat: 40.71427 lon: -74.00597 facility: Memorial Sloan Kettering Nassau (Limited Protocol Activites) status: RECRUITING city: Rockville Centre state: New York zip: 11553 country: United States name: Allison Applebaum, PhD role: CONTACT phone: 646-888-0034 lat: 40.65871 lon: -73.64124 hasResults: False

 nctId: NCT06307522 id: MRG24ALC briefTitle: MRG-001 in Patients With Alcoholic Hepatitis overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-09-01 date: 2026-12-01 date: 2024-03-13 date: 2024-03-13 name: MedRegen LLC class: INDUSTRY briefSummary: The goal of this study is to test MRG-001 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of MRG-001 in patients with severe alcoholic hepatitis (AH). conditions: Alcoholic Hepatitis conditions: Acute Alcoholic Hepatitis studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: MRG-001 measure: Assessment of Treatment-Emergent Adverse Events measure: Pharmacokinetic Response measure: Pharmacodynamic Response sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06307509 id: GN23AN097 briefTitle: Adiposity and Immunometabolism in Sepsis acronym: AIMS overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-04-30 date: 2025-07-31 date: 2024-03-13 date: 2024-03-13 name: NHS Greater Glasgow and Clyde class: OTHER name: University of Glasgow briefSummary: Obesity has been shown to increase adverse outcomes in some critically ill patients e.g. those with COVID-19. For patients with sepsis this association is less clear cut but there is evidence that body fat distribution, resulting from impaired subcutaneous adipose tissue function, is associated with adverse clinical outcomes in critical care. The investigators aim to study subcutaneous adipose tissue function in lean and obese sepsis patients in critical care and compare that to healthy controls.

First, the study will investigate differences in adipose tissue function (inflammation and mitochondrial function) related to obesity. Second, the investigators will examine whether lean critically ill patients with sepsis have enhanced adipose tissue inflammation and mitochondrial dysfunction compared to lean controls and whether this is further exacerbated by obesity.

Patients will be either undergoing emergency abdominal surgery, or will have been admitted to a critical care unit with a diagnosis of sepsis.

The investigators will collect blood and adipose tissue biopsies from the patients, and these will be analysed for markers of inflammation and of mitochondrial function.

The aim is to better understand the relationship between obesity, inflammation, mitochondrial dysfunction and sepsis. The investigators hope that this may improve the understanding of the pathophysiology of sepsis and allow more targeted interventions for patients based on differences in their baseline metabolic state. conditions: Obesity conditions: Sepsis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Diagnosis of sepsis measure: Difference in adipocyte cytokine secretion between patients with sepsis, and patients without sepsis, and between SAT and VAT samples measure: Differences in adipocyte size measure: Differences in mitochondrial morphology measure: Differences in adipocyte pro-inflammatory gene expression measure: Differences in adipocyte mitochondrial number measure: Differences in adipocyte mitochondrial viability measure: Differences in SVF cytokine secretion measure: Differences in capacity of pre-adipocytes to differentiate into mature adipocytes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Critical Care Medicine, Queen Elizabeth University Hospital city: Glasgow zip: G51 4TF country: United Kingdom lat: 55.86515 lon: -4.25763 hasResults: False

 nctId: NCT06307496 id: Pro00133913 briefTitle: VIDeOS for Smoking Cessation overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-04 date: 2025-07 date: 2024-03-12 date: 2024-03-12 name: Medical University of South Carolina class: OTHER name: Alliance NCORP Research Base Cancer Control Program briefSummary: The purpose of the current study is to pilot the efficacy, feasibility, and acceptability of an evidence-based smoking cessation intervention adapted for cancer patients and delivered via video. Investigators aim to assess if this intervention is considered acceptable by participants, feasible to implement, and effective at increasing knowledge about smoking cessation before conducting a fully powered clinical trial. conditions: Cancer conditions: Smoking Cessation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: Smoking cessation intervention name: Informational intervention measure: Acceptability measure: Feasibility measure: Retention Rates measure: Changes in knowledge about quitting smoking measure: Changes in smoking behaviors sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06307483 id: 20240108 briefTitle: Dose-effect Relationship of Tai Chi on Health Promotion in Different Age Groups overallStatus: COMPLETED date: 2023-08-25 date: 2023-11-25 date: 2023-11-25 date: 2024-03-12 date: 2024-03-26 name: Beijing Sport University class: OTHER briefSummary: The purpose of this study is to investigate the physical and mental health status of middle-aged and elderly people of different ages and practicing Tai chi for different periods of time, so as to provide a strong theoretical basis and practical guidance for delaying age-related aging and preventing and treating the occurrence and development of chronic diseases. conditions: Sleep Disorder conditions: Cardiovascular Diseases conditions: Hypertension conditions: Cognitive Impairment conditions: Metabolic Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 499 type: ACTUAL name: Taichi group name: Exercise group measure: Pittsburgh Sleep Quality Index measure: Heart rate variability (HRV) measure: Flow-mediated dilation (FMD) measure: Cardiac Output (CO) measure: Intima-Media Thickness (IMT) measure: The Berg Balance Scale（BBS） measure: The 30-s Chair Stand Test measure: Lower limb muscle strength test measure: Body Fat Percentage measure: Finger-Ring Test measure: Hand Grip Strength measure: Upper and Lower Body Flexibility measure: The SARC-F scale measure: Shape Trail Test (STT) measure: 1-back Task more-odd shifting Task Stroop Task measure: Timed Up and Go measure: Close-eyed stepping in place measure: Single-leg stance with eyes closed measure: Ankle-Brachial Index (ABI) measure: Short-Physical Performance Battery (SPPB) measure: Hospital Anxiety and Depression Scale (HADS) measure: Blood pressure variability (BPV) measure: HUR Labs Balance Software Suite measure: E/A ratio measure: Star Excursion Balance Test apparatus（SEBT） measure: Montreal Cognitive Assessment(MoCA) measure: Brachial-ankle pulse wave velocity (BaPWV) sex: ALL minimumAge: 20 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Sport University city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06307470 id: 276879 briefTitle: Nurse-led Mind-body Intervention on Sexual Health for Breast Cancer Survivors overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05-30 date: 2024-05-30 date: 2024-03-12 date: 2024-03-20 name: University of Arkansas class: OTHER name: Intimate Pathways Center for Sexual Health briefSummary: The goal of this clinical trial is to test the efficacy of a nurse-led psychoeducational sexual health intervention for young women breast cancer survivors. The main questions it aims to answer are:

1. What is the feasibility of this intervention in an online, private setting?
2. What is the effect of this intervention on reducing menopausal symptoms, improving sexual functioning, and enhancing body image?

Participants will participate in a nurse-led psychoeducational intervention for 8 sessions lasting approximately an hour each over the course of 8 - 10 weeks. Each participant will complete survey items at the beginning, end, and six-weeks after the last session. Participants will be compensated up to $150 in gift cards as a thank-you for their time. conditions: Women's Health: Neoplasm of Breast conditions: Menopause, Premature conditions: Body Image conditions: Sexual Dysfunction conditions: Cancer, Breast studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 42 type: ESTIMATED name: EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience) measure: Vulvovaginal Symptoms Questionnaire (VSQ) measure: Body Image Scale measure: Female Sexual Functioning Index sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06307457 id: A5481188 briefTitle: A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark. overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-06 date: 2024-08-31 date: 2024-08-31 date: 2024-03-12 date: 2024-03-27 name: Pfizer class: INDUSTRY briefSummary: The purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer. The study will consider participants who:

* have advanced or metastatic breast cancer that is spread to other parts of the body.
* have HR+/HER2- (hormone receptor positive\* / human epidermal growth factor receptor 2 negative\*\*) breast cancer types.

  * Hormone receptor positive (HR+): are cells that have a group of proteins that bind to a specific hormone. For example, some breast cancer cells have receptors for the hormones estrogen or progesterone.

These cells are hormone receptor positive, and they need estrogen or progesterone to grow. This can affect how the cancer is treated. Knowing if the cancer is hormone receptor positive may help plan treatment.

* Human epidermal growth factor receptor 2 negative (HER2-): cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2 negative may grow more slowly and are less likely to recur (come back) or spread to other parts of the body than cancer cells that have a large amount of HER2 on their surface. Checking to see if a cancer is HER2 negative may help plan treatment.

  * have started treatment in the period between January 2017 and December 2021.

The study will describe the treatment effect for different patient groups in terms of age and comorbidities. Comorbidity is the condition of having two or more diseases at the same time. The data is collected by the Danish Breast Cancer Group in the period between 2017 to 2023. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 580 type: ESTIMATED name: Palbociclib in combination with AI measure: Progression-free Survival (PFS) of all mBC patients receiving palbociclib in combination with AI as first-line treatment measure: Overall Survival (OS) of all mBC patients receiving palbociclib in combination with AI as first-line treatment measure: Age distribution in the full data set of mBC patients receiving palbociclib + AI as first-line treatment measure: PFS in mBC patients below 65 years of age receiving palbociclib + AI as first-line treatment measure: PFS in mBC patients between 65-74 years of age receiving palbociclib + AI as first-line treatment measure: PFS in mBC patients 75+ years of age receiving palbociclib + AI as first-line treatment measure: OS in mBC patients below 65 years of age receiving palbociclib + AI as first-line treatment measure: OS in mBC patients between 65-74 years of age receiving palbociclib + AI as first-line treatment measure: OS in mBC patients 75+ years of age receiving palbociclib + AI as first-line treatment measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into Charlson Comorbidity Index (CCI) point score of 0 measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 1 measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 2 measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 3 or higher (3+) measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 0 measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 1 measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 2 measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into CCI point score of 3 or higher (3+) measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment no comorbidity measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment one comorbidity measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment with two or more comorbidities measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment no comorbidity measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment one comorbidity measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment with two or more comorbidities measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Cardiac disease measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Vascular disease measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Metabolic disease measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Psychiatric disease measure: PFS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Blood and lymphatic system measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Cardiac disease measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Vascular disease measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Metabolic disease measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Psychiatric disease measure: OS in the full dataset of mBC patients receiving palbociclib + AI as first-line treatment split into type of comorbidity: Blood and lymphatic system sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Copenhagen University Hospital, Rigshospitalet city: Copenhagen zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06307444 id: stellate block and ESP block briefTitle: Ultrasound-Guided Erectro Spinae Plane Block Versus Stellate Ganglion Block for Patients With Upper Limb Acute Herpes Zoster Pain. overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-10-01 date: 2024-11-01 date: 2024-03-12 date: 2024-03-12 name: Tanta University class: OTHER briefSummary: Herpes zoster (HZ) is a painful, eruptive, viral condition results from reactivation of the latent varicella zoster virus after the primary infection. The selection of an effective analgesic method in the acute phase of herpes zoster can decrease the incidence of postherpetic neuralgia by reducing neural sensitization. The stellate ganglion is present in 80% of the general population and is composed of the inferior cervical ganglion and the first thoracic ganglion fusion. It lies anterior to the neck of the first rib and extends to the inferior aspect of the transverse process of C7. The erector spinae plane (ESP) block has been reported to provide diffuse and effective analgesia in the cervical, thoracic, and lumbar regions. conditions: Acute Herpes Zoster Pain Managment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 93 type: ESTIMATED name: Ultrasound-Guided Stellate Ganglion Block name: T2 T3 (High Thorathic) ESP Block measure: reduction of a numeric rating scale (NRS) pain score sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06307431 id: V940-004 id: 2023-505177-32 type: OTHER domain: EU CT briefTitle: A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004) overallStatus: RECRUITING date: 2024-04-10 date: 2028-01-08 date: 2032-06-08 date: 2024-03-12 date: 2024-04-29 name: Merck Sharp & Dohme LLC class: INDUSTRY name: ModernaTX, Inc. briefSummary: The primary objective of the study is to compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator. The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS. conditions: Renal Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 272 type: ESTIMATED name: V940 name: Pembrolizumab name: Placebo measure: Disease-Free Survival (DFS) measure: Overall Survival (OS) measure: Distant Metastasis-free survival (DMFS) measure: Percentage of Participants Who Experience an Adverse Event (AE) measure: Percentage of Participants Who Discontinue Study Treatment Due to an AE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yale-New Haven Hospital-Yale Cancer Center ( Site 0102) status: RECRUITING city: New Haven state: Connecticut zip: 06510 country: United States name: Study Coordinator role: CONTACT phone: 203-785-5720 lat: 41.30815 lon: -72.92816 facility: Macquarie University-MQ Health Clinical Trials Unit ( Site 1502) status: RECRUITING city: Macquarie University state: New South Wales zip: 2109 country: Australia name: Study Coordinator role: CONTACT phone: +61 2 9812 3526 facility: CHU de Quebec - Université Laval - Hotel Dieu de Quebec ( Site 0008) status: RECRUITING city: Québec state: Quebec zip: G1R 2J6 country: Canada name: Study Coordinator role: CONTACT phone: 4185254444 lat: 46.81228 lon: -71.21454 facility: FALP-UIDO ( Site 1202) status: RECRUITING city: Santiago state: Region M. De Santiago zip: 7500921 country: Chile name: Study Coordinator role: CONTACT phone: 56224457254 lat: -33.45694 lon: -70.64827 facility: ONCOCENTRO APYS-ACEREY ( Site 1200) status: RECRUITING city: Viña del Mar state: Valparaiso zip: 2520598 country: Chile name: Study Coordinator role: CONTACT phone: +56992369820 lat: -33.02457 lon: -71.55183 hasResults: False

 nctId: NCT06307418 id: Carer eSupport RCT briefTitle: Internet-based Support for Informal Caregivers of Patients With Head and Neck Cancer - Carer eSupport overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-10-31 date: 2025-10-31 date: 2024-03-12 date: 2024-04-01 name: Uppsala University class: OTHER name: The Swedish Research Council name: Swedish Cancer Society name: Umeå University name: Region Örebro County name: Sahlgrenska University Hospital, Sweden name: University Hospital, Umeå name: Uppsala University Hospital briefSummary: The aim of this randomized controlled trial is to investigate the effects of internet-based support (Carer eSupport) on preparedness for caregiving in informal caregivers of patients with head and neck cancer. The main question\[s\] it aims to answer are:

* What are the effects of internet-based support on informal caregivers preparedness for caregiving?
* What are the effects of internet-based support on informal caregivers burden and wellbeing?

Informal caregivers who are randomized to Carer eSupport will have access to Carer eSupport for 18 weeks and they will be asked to complete questionnaires (outcome measures) at:

* baseline (before randomization)
* 18 weeks (post-intervention) and at
* 3 months after the intervention is completed (long term follow-up).

Informal caregivers in the intervention group will be compared to informal caregivers who receive standard care support regarding preparedness for caregiving, caregiver burden and wellbeing. conditions: Head and Neck Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Informal caregivers of patients with Head and neck cancer will be randomized to internet-based support or to support as usual. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 110 type: ESTIMATED name: Carer eSupport measure: The self-reported questionnaire Preparedness for caregiving scale measure: The self-reported questionnaire Caregiver Burden Scale measure: The self-reported questionnaire Depression Anxiety Stress Scale-21 (DASS21) measure: The self-reported health-related quality of life questionnaire RAND-36 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Örebro University Hospital city: Örebro state: Blekinge Län zip: 70185 country: Sweden lat: 59.27412 lon: 15.2066 facility: Uppsala university hospital city: Uppsala state: Uppsala Län zip: 75105 country: Sweden lat: 59.85882 lon: 17.63889 facility: Norrland University Hospital city: Umeå state: Västerbottens Län zip: 90737 country: Sweden lat: 63.82842 lon: 20.25972 facility: Sahlgrenska university hospital city: Göteborg state: Västra Götaland zip: 41345 country: Sweden lat: 57.70716 lon: 11.96679 hasResults: False

 nctId: NCT06307405 id: WJP2023 briefTitle: The Value of mNGS in Diagnosis of Pulmonary Infection overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-04-20 date: 2025-09-30 date: 2024-03-12 date: 2024-03-12 name: Yunfeng Hou class: OTHER briefSummary: Retrospective analysis of clinical data from 50 hospital-admitted patients with suspected pulmonary infection (as judged by clinical manifestations and imaging findings) was performed on study participants who had collected two different samples of alveolar lavage fluid (BALF) and sputum and underwent metagenomic next generation sequencing (mNGS) and routine pathogen detection, respectively. The positive rate of pathogen detection and the consistency of pathogen detection results of the two detection methods were compared to evaluate the clinical manifestation and role of mNGS in pathogen diagnosis. conditions: Pulmonary Infection studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED name: next generation sequencing measure: Etiological detection rates of two detection techniques measure: Consistency of detection results of two detection techniques sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06307392 id: RC22_0393 briefTitle: Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation (BETA Trial) acronym: BETA overallStatus: RECRUITING date: 2024-03-26 date: 2027-03-26 date: 2027-03-31 date: 2024-03-12 date: 2024-04-05 name: Nantes University Hospital class: OTHER briefSummary: Emergency intubation is routinely performed in the prehospital setting. Airway management in the prehospital setting has substantial challenges, such as hostile environment or lack of technical support in case of first attempt intubation failure, and inherent risk of complications, such as hypoxemia, aspiration or oesophageal intubation. This risk is higher when several attempts are needed to succeed endotracheal intubation. Thus, a successful first attempt intubation is highly desirable to avoid adverse intubation-related events. Noteworthy, prehospital emergency intubation is associated with a lower rate of first attempt intubation success when compared to emergency intubation in the emergency department (ED). Research is needed to overcome the specific challenges of airway management in the prehospital setting, and to improve the safety and efficiency of prehospital emergency intubation. Literature reports that the use of assistive devices such as bougie may increase the rate of first-attempt intubation success in the ED. To date, no randomized trial has ever studied this device in the prehospital setting. Thus, the aim of the BETA trial is to compare first attempt intubation success facilitated by the bougie versus the endotracheal tube alone in the prehospital setting. conditions: Acute Respiratory Failure Requiring Intubation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 710 type: ESTIMATED name: First intubation attempt with endotracheal tube plus bougie name: First intubation attempt with endotracheal tube alone measure: Number of first pass success during prehospital emergency intubation measure: Occurrence of hypoxia measure: Occurrence of bradycardia measure: Occurrence of cardiac arrest measure: Occurrence of death measure: Occurrence of pulmonary aspirations measure: Occurrence of severe cardiovascular collapse measure: Time between blade introduction to the confirmation of a correct tube placement measure: Change in SpO2 (pulsed oxygen saturation) from the time of induction to lowest SpO2 up to 2 minutes after confirmation of correct tube placement measure: Occurrence of change in SpO2 of more than 3% from the time of induction to 2 minutes after confirmation of correct tube placement measure: Cormack-Lehane grade of glottic view at first intubation attempt measure: Number of laryngoscopies attempts to achieve correct endotracheal tube placement measure: Number of patients for whom the placement of an endotracheal tube was not possible in the pre-hospital setting measure: Difficulty perceived by the operator on first intubation attempt measure: Occurrence of injuries measure: Occurrence of complications measure: Change of SpO2/FiO2 ratio (pulsed oxygen saturation / fraction of inspired oxygen) between the time of confirmation of correct tube placement and the minimum ratio sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nantes University Hospital status: RECRUITING city: Nantes state: Loire Atlantique zip: 44093 country: France name: Quentin Le Bastard, MD role: CONTACT phone: 0240087839 email: quentin.lebastard@chu-nantes.fr name: Quentin Le Bastard, MD role: PRINCIPAL_INVESTIGATOR lat: 47.21725 lon: -1.55336 hasResults: False

 nctId: NCT06307379 id: EC 23022 briefTitle: Patient Reported Outcome and Experience Measures for Bronchoscopic Procedures acronym: BRONCHOPROEM overallStatus: RECRUITING date: 2024-02-13 date: 2025-12-30 date: 2025-12-30 date: 2024-03-12 date: 2024-03-12 name: Vitaz class: OTHER briefSummary: 'Patient-reported outcomes' (PROMS) and 'patient-reported experiences' (PREMS) are increasingly important parameters in evaluating and adjusting clinical procedures and strategies in healthcare.

Validated disease-specific PROMS related to bronchoscopic procedures are not available and examples in the medical literature are very scarce. conditions: Bronchial Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: no intervention measure: Procedure-related dyspnea scale (VAS) measure: Procedure-related pain scale (VAS) measure: Procedure related cough scale (VAS) measure: General patient satisfaction measure: Procedure-related complications: measure: Sedation-related complications measure: Diagnostic yield sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VITAZ status: RECRUITING city: Sint-Niklaas country: Belgium name: Jonas Yserbyt role: CONTACT email: jonas.yserbyt@vitaz.be lat: 51.16509 lon: 4.1437 hasResults: False

 nctId: NCT06307366 id: ErasmusMC10365 briefTitle: Perceptions and Experiences of (Family Members of) People With Mental Illness About the Chance for Mental Illness in (Future) Children, and Needs for Care and Research acronym: PANDAcc overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-12 date: 2024-03-12 name: Erasmus Medical Center class: OTHER briefSummary: Despite consistent evidence that mental illness runs in families, intergenerational transmission of risk of mental illness is rarely considered in clinical practice. Neither preventive programs for children of parents with mental illness are usually implemented in care, nor supportive programs for parenting. Furthermore, parents with mental illness are not always aware of how their disorder may impact the well-being of their children. To date, the needs for counseling, care and research in parents with mental illness and family members of people with mental illness are unclear. Therefore, this prospective qualitative interview study aims to gain insights into the perceptions and experiences of (future) parents with mental illness, partners and family members of people with mental illness about risk for and resilience against mental illness in (future) children, as well as their needs for counseling, care and research. conditions: Mental Illness studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 10 type: ESTIMATED name: No intervention will be used measure: Themes around the topics (related to perceptions and experiences) explored. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus Medical Center city: Rotterdam state: Zuid-Holland zip: 3000CB country: Netherlands name: Lisanne AE van Houtum, PhD role: CONTACT phone: +31107037005 email: l.vanhoutum@erasmusmc.nl name: Hilmar H Bijma, MD, PhD role: CONTACT phone: +31107036109 email: h.bijma@erasmusmc.nl name: Hilmar H Bijma, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Neeltje EM van Haren, PhD role: SUB_INVESTIGATOR name: Lisanne AE van Houtum, PhD role: SUB_INVESTIGATOR name: Eline MP Poels, MD, PhD role: SUB_INVESTIGATOR lat: 51.9225 lon: 4.47917 hasResults: False

 nctId: NCT06307353 id: Soh_Med_23_12_05MS briefTitle: Trends of Contraception Methods in Urban Medical Center in el_Balyana overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-10-01 date: 2025-03-01 date: 2024-03-12 date: 2024-03-12 name: Sohag University class: OTHER briefSummary: family planning is avital primary Health care intervention that saves lives of mothers and infants empowers women and support their choices regarding their health public life and additional education .In addition family planning is considered as a short term intervention to limit population growth and manage overpopulation problems.Globally the contraception prevalance rate an indicator for family planning programs continue to face challenges in developing countries. conditions: Contraception studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 385 type: ESTIMATED name: trends of contraception methods measure: number of married women in child bearing period attending the El_Balyana Medical Center using contraception methods . sex: FEMALE minimumAge: 15 Years maximumAge: 49 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06307340 id: 22-01058 briefTitle: Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-10 date: 2024-03-12 date: 2024-04-04 name: NYU Langone Health class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: During this 36-month R34 trial, eight study phases are proposed to adapt an evidence-based post traumatic stress disorder (PTSD) intervention (STAIR-NT) and layer it into a methadone maintenance treatment (MMT) program (START Treatment and Recovery centers) in New York City for use among individuals engaged in stimulant-opioid polysubstance use. The study aims to adapt STAIR-NT to a massed treatment schedule. Once an adapted protocol is complete, it will be tested for feasibility, acceptability, and short-term polysubstance and PTSD symptomology outcomes in a pilot randomized control trial (RCT) of 80 participants. Participants who screen eligible and consent will be randomized 1:1 to the adapted STAIR-NT intervention or treatment as usual (TAU) using randomization blocks of two and two and four via a computer-generated randomization sequence. Participants assigned to the intervention will receive the adapted massed delivery of STAIR-NT by trained counselors. conditions: Polysubstance Abuse conditions: Posttraumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: The data analyst is blinded to participant arm. whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT) name: Treatment as Usual measure: Proportion of Eligible Participants measure: Proportion of Eligible Participants who Enroll measure: Number of Intervention Sessions Completed measure: Clinician-Rated Feasibility of Intervention Measure (FIM) Score measure: Clinician-Rated Feasibility of Acceptability of Intervention Measure (AIM) Score measure: Number of Days of Co-Use of Cocaine and Illicit Opioids measure: Number of Substances Used based on ASI Self-Report measure: Number of Substances Used based on Urine Drug Screen measure: Number of Substances Used based on Chart Abstraction of Toxicology Results measure: PTSD Checklist for DSM-5 (PCL-5) Score measure: Negative Mood Regulation Scale Score measure: Inventory of Interpersonal Problems Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Florida State University city: Tallahassee state: Florida zip: 32306 country: United States name: Tanya Renn, PhD role: PRINCIPAL_INVESTIGATOR lat: 30.43826 lon: -84.28073 facility: START Treatment and Recovery Centers city: Brooklyn state: New York zip: 11238 country: United States name: Ana Ventuneac role: PRINCIPAL_INVESTIGATOR lat: 40.6501 lon: -73.94958 facility: NYU Langone Health city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06307327 id: NFEC-2024-098 briefTitle: Comparative Study of New Classification and Traditional Classification of Radioactive Oropharyngeal Mucositis overallStatus: RECRUITING date: 2024-03 date: 2025-12 date: 2026-12 date: 2024-03-12 date: 2024-03-26 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: Radiation oropharyngeal mucositis is one of the most painful side effects of radiotherapy in patients with head and neck tumors. However, the traditional radioactive oropharyngeal mucositis grading system has the problem of poor evaluation consistency. To solve this problem, we innovatively classify radiation oropharyngeal mucositis into four types according to the four-stage histopathological changes of acute radiation injury: (1) congestive; (2) Scattered erosion type; (3) Fusion erosion type; (4) Ulcer type. We intend to conduct a multicenter observational cohort study to compare the consistency of different physicians in the assessment of radiation oropharyngeal mucositis with new and traditional classifications, and to explore changes in blood markers of different types of oropharyngeal mucositis using clinical residual blood samples. conditions: Head and Neck Cancer conditions: Radiation-Induced Mucositis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 894 type: ESTIMATED measure: Evaluation consistency sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Southern medical university status: RECRUITING city: Guangzhou state: Guangdong zip: 510515 country: China name: Jian Guan, M.D role: CONTACT phone: 86+13632102247 email: guanjian5461@163.com lat: 23.11667 lon: 113.25 facility: Huizhou Central People's Hospital status: NOT_YET_RECRUITING city: Huizhou state: Guangdong zip: 516000 country: China name: Yunming Tian role: CONTACT lat: 23.11147 lon: 114.41523 facility: Jieyang people's hospital status: NOT_YET_RECRUITING city: Jieyang state: Guangdong zip: 522000 country: China name: Peibao Lai role: CONTACT phone: 86+15975196057 email: boa71@139.com lat: 23.5418 lon: 116.36581 facility: Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou status: NOT_YET_RECRUITING city: Meizhou state: Guangdong zip: 514000 country: China name: Jianda Sun role: CONTACT lat: 24.2886 lon: 116.11767 hasResults: False

 nctId: NCT06307314 id: NFEC-2024-093 briefTitle: Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis overallStatus: RECRUITING date: 2024-02-01 date: 2026-12-01 date: 2026-12-31 date: 2024-03-12 date: 2024-03-12 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: Head and neck squamous cell carcinoma (SCC) is the sixth most common cancer worldwide, with more than 700,000 new cases and more than 350,000 deaths each year. At present, radiotherapy is an important measure to control the recurrence of head and neck tumors, but almost all patients with head and neck squamous cell carcinoma will have acute inflammatory reactions such as radiotherapy-induced oral mucositis (RIOM) after radiotherapy, which seriously affects the quality of life and radiotherapy efficacy of patients. Serum amyloid A1 (SAA1) is an acute phase protein associated with inflammation. Our previous basic research found that serum SAA1 expression levels can be used as biomarkers to assess the dose received by the receptor in the early stages of radiation damage. At the same time, we confirmed that the serum level of SAA1 in patients with nasopharyngeal carcinoma increased after radiotherapy. Therefore, we intend to conduct a prospective, multicenter, observational study to further explore the predictive power of plasma SAA1 levels for radiotherapy-induced oral mucositis, with a view to early screening and prevention of RIOM patients. conditions: Nasopharyngeal Carcinoma conditions: Head and Neck Cancer conditions: Radiotherapy-induced Oral Mucositis conditions: Biomarker studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: Different grades radiotherapy-induced oral mucositis measure: Start and duration of radiotherapy-induced oral mucositis measure: Side effects of radiotherapy measure: Tumor response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanfang hospital, Southern medical university status: RECRUITING city: Guangzhou state: Guangdong zip: 510515 country: China name: Jian Guan, Ph.D. role: CONTACT lat: 23.11667 lon: 113.25 facility: Fujian Provinical Hospital status: NOT_YET_RECRUITING city: Fuzhou country: China name: Yongmei Dai role: CONTACT lat: 26.06139 lon: 119.30611 facility: Huizhou Central People's Hospital status: NOT_YET_RECRUITING city: Huizhou country: China name: Yunming Tian role: CONTACT lat: 23.11147 lon: 114.41523 facility: Jieyang People's Hospital status: NOT_YET_RECRUITING city: Jieyang country: China name: Peibao Lai role: CONTACT lat: 23.5418 lon: 116.36581 facility: Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou status: NOT_YET_RECRUITING city: Meizhou country: China name: Jianda Sun role: CONTACT lat: 24.2886 lon: 116.11767 hasResults: False

 nctId: NCT06307301 id: PRO00031998 briefTitle: Study in ALS With Abatacept & IL-2 overallStatus: ACTIVE_NOT_RECRUITING date: 2021-10-28 date: 2024-10-17 date: 2024-10-17 date: 2024-03-12 date: 2024-04-16 name: The Methodist Hospital Research Institute class: OTHER briefSummary: In Amyotrophic Lateral Sclerosis (ALS), the reduction of regulatory T-lymphocyte (Treg) numbers and suppressive function correlates with rapid disease progression. The investigator completed a phase 1 study of infusions of expanded autologous Tregs in combination with subcutaneous IL-2 injections in ALS patients, which showed enhancement of Treg numbers and suppressive function in vivo. The enhanced Treg suppressive function correlated strongly with slowing and stabilization of disease progression. Drugs that enhance endogenous Treg numbers and suppressive function may also stabilize disease in ALS. This phase 1 study aims to determine whether the combination therapy of subcutaneous IL-2 and abatacept (Orencia®) is safe and well-tolerated in 6 patients with ALS, and whether the therapy enhances Treg numbers and suppressive function in vivo. conditions: Amyotrophic Lateral Sclerosis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ACTUAL name: Abatacept Injection [Orencia] and Proleukin (aldesleukin) measure: To evaluate adverse events and laboratory abnormalities to assess the safety and tolerability of abatacept followed by Interleukin 2 (IL-2) administration in ALS patients measure: Change in Regulatory T cells (Tregs) numbers in the blood from baseline measure: Change in Regulatory T cells (Tregs) suppressive function in the blood from baseline measure: Changes in the level of cytokines secreted by PBMCs from baseline measure: Changes in Appel Amyotrophic Lateral Sclerosis rating scale ( AALS) slope measure: Changes in Amyotrophic Lateral Sclerosis functional rating scale-revised (ALSFRS-R) slope measure: Changes in forced vital capacity (FVC) and maximum inspiratory pressure (MIP) scores measure: Changes in maximum inspiratory pressure (MIP) scores sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Houston Methodist Research Institute city: Houston state: Texas zip: 77030 country: United States lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06307288 id: 20240301-2 briefTitle: Efficacy and Safety of Tranilast Combined With Minocycline in the Treatment of Rosacea overallStatus: ENROLLING_BY_INVITATION date: 2023-10-16 date: 2024-06-01 date: 2024-06-01 date: 2024-03-12 date: 2024-03-12 name: Second Affiliated Hospital of Xi'an Jiaotong University class: OTHER briefSummary: Rosacea is a chronic inflammatory skin disease with a complex pathogenesis involving multiple factors. Currently, the treatment of rosacea remains highly challenging. Mast cells, as key participants in the pathogenesis of rosacea, have been shown to alleviate rosacea symptoms with some topical, oral, and injectable mast cell stabilizers in recent years. Tranilast stabilizes mast cells and basophils by acting on their cell membranes and preventing their degranulation. Tranilast has been used in the treatment of various skin disease, such as hypertrophic scars and atopic dermatitis. Minocycline is a first-line treatment for rosacea, and low-dose minocycline treatment (50mg/day) is believed to have anti-inflammatory effects without antibacterial effects, thus minimizing the dysbiosis and bacterial resistance caused by antibiotic use. Therefore, this study aims to investigate the effectiveness and safety of combining mast cell stabilizer tranilast with low-dose minocycline treatment for rosacea, providing new treatment options and insights for rosacea patients. conditions: Rosacea studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: minocycline name: tranilast measure: lesion counts measure: Clinician's Erythema Assessment score measure: Global Flushing Severity Scale score measure: Global Acne Grading System score measure: patient satisfaction evaluation measure: melanin index measure: erythema index measure: transepidermal water loss measure: Dermatology Life Quality Index score sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: The Second Affiliated Hospital of Xi'an Jiaotong Universi city: Xi'an state: Shaanxi zip: 710000 country: China lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06307275 id: 5170221 briefTitle: Intermittent Fasting on Body Fat and Quality of Life overallStatus: RECRUITING date: 2024-03-11 date: 2024-12-31 date: 2024-12-31 date: 2024-03-12 date: 2024-04-12 name: Loma Linda University class: OTHER briefSummary: The purpose of this investigator-initiated study to check the feasibility that intermittent fasting has on body fat loss and quality of life. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 70 type: ESTIMATED name: Fasting name: non fasting measure: Body fat percentage measure: Visceral fat sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Loma Linda University status: RECRUITING city: Loma Linda state: California zip: 92350 country: United States name: Gurinder Bains, PhD role: CONTACT phone: 909-558-4000 phoneExt: 87274 email: gbains@llu.edu lat: 34.04835 lon: -117.26115 hasResults: False

 nctId: NCT06307262 id: EuroTR Registry briefTitle: European Registry of Transcatheter Repair for Tricuspid Regurgitation acronym: EuroTR overallStatus: RECRUITING date: 2023-10-23 date: 2030-12-31 date: 2030-12-31 date: 2024-03-12 date: 2024-03-15 name: LMU Klinikum class: OTHER briefSummary: To investigate clinical and survival outcomes following transcatheter tricuspid valve repair or replacement. conditions: Tricuspid Regurgitation conditions: Valvular Heart Disease conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 3000 type: ESTIMATED name: T-TEER measure: All-cause mortality measure: Technical success measure: Procedural Safety measure: Heart Failure Biomarker measure: Dyspnea on exertion measure: Functional capacity measure: Right ventricular size measure: Right ventricular function measure: Tricuspid regurgitation reduction measure: Tricuspid valve stenosis measure: Pulmonary hypertension measure: Right heart congestion measure: Hospitalization for heart failure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: LMU Klinikum status: RECRUITING city: Munich state: Bavaria zip: 81377 country: Germany name: Jörg Hausleiter, Prof. Dr. role: CONTACT phone: +49 89 4400 72360 email: Joerg.Hausleiter@med.uni-muenchen.de name: Lukas Stolz, Dr. role: CONTACT email: Lukas.Stolz@med.uni-muenchen.de lat: 48.13743 lon: 11.57549 hasResults: False

 nctId: NCT06307249 id: LU_HH_Cancer_Precision Therapy briefTitle: Precision Therapy for Solid Tumors: Synergistic CDK4/6 Inhibition and Anti-VEGF Targeting LncRNA acronym: PTST_PALBEVA overallStatus: RECRUITING date: 2023-02-15 date: 2025-12 date: 2027-12 date: 2024-03-12 date: 2024-03-12 name: Lebanese University class: OTHER name: Haykel Hospital briefSummary: Solid tumors pose significant challenges in current therapeutic approaches. Targeted therapy has emerged as a promising avenue, aiming to enhance treatment efficacy while minimizing adverse effects. This clinical trial focuses on an innovative combination of two targeted inhibitors, Palbociclib and Bevacizumab, for their potential synergistic effects in addressing these challenging malignancies. Moreover, this study incorporates a molecular approach by considering Long Non-Coding RNAs (LncRNAs) as biomarkers. Initiating with a focus on colorectal cancer, the study aims to expand its scope to other solid tumors, including lung, breast, ovarian and other cancers. Palbociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, disrupts the cell cycle progression, particularly in cancer cells with specific molecular characteristics. Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, targets angiogenesis-a critical process for tumor growth and metastasis. The rationale behind combining these agents lies in their complementary mechanisms of action, potentially leading to enhanced antitumor effects. LncRNAs have shown promise in predicting treatment response and prognosis in various cancers, providing an additional layer of precision to the treatment strategy. By elucidating the molecular basis through LncRNA analysis, the trial aims to tailor the treatment to the specific molecular profile of each patient, ultimately striving for better outcomes and improved survival rates. This novel combination therapy, coupled with a personalized biomarker-driven approach, represents a cutting-edge strategy in the pursuit of more effective and individualized treatment for solid tumors. conditions: Cancer conditions: Solid Tumor conditions: Colorectal Cancer conditions: Breast Cancer conditions: Ovarian Cancer conditions: Lung Cancer conditions: Targeted Therapy conditions: Chemotherapy conditions: Immunotherapy conditions: Precision Therapy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: SNP name: Palbociclib 125mg name: Bevacizumab measure: Assessment of Cancer Progression measure: Identification of Potential Biomarkers measure: Evaluation of Treatment Response to Palbociclib and Bevacizumab Combination Therapy measure: Survival Rates measure: Adverse Events measure: Assessment of Immune Checkpoint Expression (e.g., PD-1 and CTLA-4) measure: Measurement of Angiogenic Factors (e.g., VEGF) measure: Measurement of Tumor Proliferation Markers (e.g., Ki67, P16) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Haykel Hospital status: RECRUITING city: Tripoli state: North Lebanon zip: 961 country: Lebanon name: David Wehbe, MD role: CONTACT email: Wehbehdavid@hotmail.com name: Malak Naboulsi, PharmD role: CONTACT email: malak.naboulsi@gmail.com lat: 34.43667 lon: 35.84972 facility: Lebanese University status: RECRUITING city: Tripoli state: North Lebanon zip: 961 country: Lebanon name: Neham Makdissy, Professor role: CONTACT phone: 71210250 phoneExt: +961 email: nehman.makdissy@ul.edu.lb name: Samar Hamoui, PhD role: SUB_INVESTIGATOR name: Fida Ayoubi, PhD role: SUB_INVESTIGATOR name: Nouha Ibrahim, PhD role: SUB_INVESTIGATOR name: Nadine Ghotme, PhD role: SUB_INVESTIGATOR name: Elisa Makdessi, PhD Student role: SUB_INVESTIGATOR lat: 34.43667 lon: 35.84972 hasResults: False

 nctId: NCT06307236 id: E-41997688-050.99-105442 briefTitle: Dysmenorrhea of Emotional Freedom Techniques (EFT) and Its Effect on Perceived Stress Level overallStatus: ENROLLING_BY_INVITATION date: 2023-12-15 date: 2024-04-15 date: 2024-04-15 date: 2024-03-12 date: 2024-03-12 name: Kutahya Health Sciences University class: OTHER briefSummary: The aim of the study is to determine the effect of EFT application on the level of dysmenorrhea and stress perception in women with dysmenorrhea. For this purpose, EFT will be applied to women with dysmenorrhea with high stress perception assigned to the experimental and control groups, and their stress perceptions and dysmenorrhea levels will be re-evaluated after the application. Perceived Stress Scale (PSS) and Visual Analog Scale (VAS) will be used in the research. conditions: Dysmenorrhea Primary conditions: Stress conditions: Emotional Freedom studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Study primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Single Blinded whoMasked: PARTICIPANT count: 56 type: ESTIMATED name: Emotional Freedom Techniques measure: EFT application measure: Control sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Kütahya Health Science University city: Kütahya zip: 43000 country: Turkey lat: 39.42417 lon: 29.98333 hasResults: False

 nctId: NCT06307223 id: 20240301 briefTitle: Efficacy and Safety of 30% Supramolecular Salicylic Acid Combined With Supramolecular Active Zinc in the Treatment of Malassezia Folliculitis overallStatus: COMPLETED date: 2022-06-07 date: 2023-09-20 date: 2023-09-20 date: 2024-03-12 date: 2024-03-12 name: Second Affiliated Hospital of Xi'an Jiaotong University class: OTHER briefSummary: Malassezia folliculitis is a common dermatological disorder. While antifungal agents generally demonstrate efficacy in application, the prevalence of recurrence and drug resistance remains a common occurrence. Supramolecular salicylic acid represents a novel class of superficial chemical peel agents, exhibiting keratolytic, anti-inflammatory, and bacteriostatic properties. Zinc pyrithione has broad spectrum antibacterial, antifungal, and anti-inflammatory effects. In the present study, investigators evaluated the clinical efficacy of topical application of supramolecular salicylic acid in combination with zinc pyrithione for the treatment and prevention of Malassezia folliculitis recurrence. All data are recorded and compared after the end of the experiment. The enrolled patients received daily application of topical supramolecular active zinc anti-dandruff lotion, in conjunction with weekly application of 30% supramolecular salicylic acid, for a duration of 8 weeks. Lesion counts, Malassezia detection, clinical symptom scores, patient satisfaction, and side effects were recorded at each visit till the week 12. conditions: Malassezia Folliculitis studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 21 type: ACTUAL name: 30% supramolecular salicylic acid name: supramolecular active zinc measure: lesion counts measure: The reduction rate of lesion counts measure: Clinical efficacy measure: Clinical symptoms scores sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Xi'an Jiaotong University city: Xi'an state: Shaanxi zip: 710000 country: China lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06307210 id: coreset_2020_2022 briefTitle: Is Inpatient Rehabilitation Effective for Very Old Patients? overallStatus: COMPLETED date: 2020-01-01 date: 2022-12-31 date: 2023-01-01 date: 2024-03-12 date: 2024-03-12 name: Klinik Valens class: OTHER briefSummary: The goal of this retrospective longitudinal observational study is to compare the effects of physical and mental performance as well as quality of life in patients with neurological and musculoskeletal disorders.

The main question it aims to answer is: Do very old patients benefit in a similar way from inpatient rehabilitation like younger patients? Data from about 2000 patients will be retrospectively analyzed. Functional Independence Measurement (FIM), Timed Up and Go Test (TUG), EuroQol 5 Dimensions (EQ-5D) and Patient Reported Outcomes Measurement Information System (PROMIS) were recorded on admission and discharge.

Researchers will compare the age group 75 to 84 and 85 to 99 to see if physical and mental performance as well as quality of life will improve. conditions: Activity, Motor conditions: Elderly Patients conditions: Musculoskeletal Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2270 type: ACTUAL name: inpatient rehabilitation measure: FIM measure: TUG measure: EQ-5D (Quality of life) measure: PROMIS sex: ALL minimumAge: 75 Years maximumAge: 100 Years stdAges: OLDER_ADULT facility: Klinik Valens city: Valens state: Saint Gallen zip: CH-7317 country: Switzerland lat: 46.96658 lon: 9.47705 hasResults: False

 nctId: NCT06307197 id: INRCA_008_2023 briefTitle: HAAL: HeAlthy Ageing Eco-system for peopLe With Dementia acronym: HAAL overallStatus: RECRUITING date: 2023-10-02 date: 2024-04-15 date: 2024-04-15 date: 2024-03-12 date: 2024-03-12 name: Istituto Nazionale di Ricovero e Cura per Anziani class: OTHER briefSummary: HAAL project aims to test several technological devices in order to improve the quality of life of older people with dementia and their informal and formal caregiver. conditions: Dementia conditions: Devices conditions: Artificial Intelligence conditions: Older People conditions: Caregiver Burden studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 10 type: ESTIMATED name: HAAL platform measure: Care load of caregivers sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: IRCCS INRCA Hospital status: RECRUITING city: Ancona country: Italy name: Elvira Maranesi role: CONTACT email: e.maranesi@inrca.it name: Roberta Bevilacqua role: PRINCIPAL_INVESTIGATOR lat: 43.5942 lon: 13.50337 hasResults: False

 nctId: NCT06307184 id: 2301-LIS-007-AN briefTitle: Assessing the Convenience of Natural Proliferative Phase Frozen Embryo Transfer overallStatus: RECRUITING date: 2024-02-23 date: 2024-10 date: 2025-07 date: 2024-03-12 date: 2024-03-12 name: Instituto Valenciano de Infertilidade de Lisboa class: NETWORK name: Gedeon Richter Ltd. briefSummary: This study will assess the convenience of the natural proliferative phase frozen embryo transfer (NPP-FET) in terms of number of number of appointments needed before cycle scheduling. conditions: Frozen Embryo Transfer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 530 type: ESTIMATED name: Natural proliferative phase frozen embryo transfer measure: Number of appointments needed before cycle scheduling measure: Cycle duration until embryo transfer (days) measure: Proportion of patients with low progesterone values on the day of embryo transfer measure: Human corionic gonadotropin (hCG) positive rate measure: Miscarriage rate measure: Ongoing pregnancy rate measure: Live birth rate measure: Serum Relaxin-2 levels measure: Serum Luteinizing Hormone (LH) levels sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Instituto Valenciano de Infertilidade status: RECRUITING city: Lisboa country: Portugal name: Samuel Santos-Ribeiro, MD PhD role: CONTACT lat: 38.71667 lon: -9.13333 hasResults: False

 nctId: NCT06307171 id: 2023-11 briefTitle: Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers acronym: LeishmARPs overallStatus: RECRUITING date: 2023-05-22 date: 2026-11 date: 2026-11 date: 2024-03-12 date: 2024-03-12 name: IRCCS Sacro Cuore Don Calabria di Negrar class: OTHER briefSummary: This is an exploratory experimental multicentre study on archived serum samples and on prospectively collected serum samples and blood samples.

General objectives of the study are: to identify specific biomarkers in order to develop more accurate serological tests for the screening of Leishmania infections that does not present cross-reaction with other infectious diseases; to unveil the Antigen Recognition Patterns (ARPs) of Leishmania infection in humans; to verify whether the ARPs and the new biomarkers are common to different Leishmania infantum strains isolated in Italy as well as in other part of the World and to different strains of L. donovani isolated in Sudan as well as in other part of the World and discard any possible cross reaction with other infectious diseases such as Chagas, TB, leprosy or malaria. conditions: Leishmaniasis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 170 type: ESTIMATED name: In-house Western blot, specific for Leishmania measure: Biomarkers from Leishmania spp measure: ARPs in different Leishmania infantum and L. donovani strains measure: Cross reaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Sacro Cuore Don Calabria hospital status: RECRUITING city: Negrar state: Verona zip: 37024 country: Italy name: Silvia Longoni role: CONTACT phone: +390456013111 email: silvia.longoni@sacrocuore.it name: Silvia Longoni role: PRINCIPAL_INVESTIGATOR lat: 45.52918 lon: 10.93899 hasResults: False

 nctId: NCT06307158 id: CT2024-ZJU-OBS1 briefTitle: Influence of Intraoperative Blood Salvage and Autotransfusion on Tumor Recurrence After Deceased Donor Liver Transplantation overallStatus: COMPLETED date: 2015-01-01 date: 2020-12-31 date: 2021-12-31 date: 2024-03-12 date: 2024-03-12 name: Zhejiang University class: OTHER name: Shulan (Hangzhou) Hospital briefSummary: The practice of intraoperative blood salvage and autotransfusion (IBSA) during deceased donor liver transplantation (DDLT) for hepatocellular carcinoma (HCC) can potentially reduce the need for allogeneic blood transfusion. However, implementing IBSA remains debatable due to concerns about its possible detrimental effects on oncologic recurrence. Hence, a nationwide multi-center study was conducted to investigate further the association between IBSA and post-transplant HCC recurrence, including a stratified subgroup analysis. conditions: Liver Transplant; Complications studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 998 type: ACTUAL measure: Postoperative recurrence of liver cancer sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06307145 id: K-NHIS-HIP briefTitle: Korea Hip Replacement Surgery Registry overallStatus: COMPLETED date: 2003-01-01 date: 2020-12-31 date: 2020-12-31 date: 2024-03-12 date: 2024-03-12 name: Samsung Medical Center class: OTHER briefSummary: This cohort study obtained data from the Korean National Health Insurance Service (K-NHIS) database. For the hip replacement registry, we included all adult patients older than 19 who received total or hemiarthroplasty surgery between January 1, 2003, and December 31, 2019. Using this registry, we compared efficacy and safety by type of head or liner. conditions: Hip Replacement Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 124556 type: ACTUAL measure: Cancer sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06307132 id: SAHoWMU-CR2024-03-106 briefTitle: Drug Metabolism, Excretion, and Human Body Composition of Aximus Capsules overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-31 date: 2024-06-30 date: 2024-08-31 date: 2024-03-12 date: 2024-03-12 name: Second Affiliated Hospital of Wenzhou Medical University class: OTHER briefSummary: This project will be based on the bioequivalence test of Aximus capsules, measuring the body composition indicators of healthy subjects before and after medication, and collecting urine samples from subjects at different time periods after medication, measuring urine drug concentration, calculating urine excretion, analyzing the individualized differences in metabolism and excretion of Aximus capsules under different health states of human components, and providing guidance for clinical precision medication. conditions: Bioequivalence Trial studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 26 type: ESTIMATED name: Aximus capsules（test） name: Aximus capsules（reference） measure: Excretion volume sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: The Second Affiliated Hospital of WMU Phase l Clinical Trial Unit /Center Of Bioequivalence Study city: Wenzhou country: China lat: 27.99942 lon: 120.66682 hasResults: False

 nctId: NCT06307119 id: 2020-01 briefTitle: Model of Human Occupation-Based Intervention on Premenstrual Syndrome Symptoms overallStatus: COMPLETED date: 2023-03-01 date: 2024-03-01 date: 2024-03-02 date: 2024-03-12 date: 2024-03-12 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: This study was conducted to examine the effect of two different occupational therapy interventions on premenstrual syndrome symptoms in university students. This study was designed according to the CONSORT statement, which provides a standard method for randomised controlled trial (RCT) design. The study was approved by the Local Ethics Committee. Written informed consent was obtained from all participants before the study. conditions: Premenstrual Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 95 type: ACTUAL name: Occupational Therapy and Relaxation Group name: Relaxation Group measure: Occupational Self-Assessment measure: The Model of Human Occupation Screening Tool (MOHOST) measure: Premenstrual Symptom Screening Tool sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Health Sciences Turkey city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06307106 id: #40\14-Jan-2024 briefTitle: Various Strategies to Reduce Acute Post Hemorrhoidectomy Pain: A Comparative Study overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-14 date: 2024-07-14 date: 2024-07-14 date: 2024-03-12 date: 2024-03-12 name: Zagazig University class: OTHER_GOV briefSummary: Since post hemorrhoidectomy pain is a severe and common post operative symptom so there is a need to find a suitable method for reducing this pain, up to our knowledge, this the first study in ZUH to compare between ketrolac, light Marcaine, corticosteroids and diclofenac sodium injection at surgical site for relieve of post operative pain. This is a randomizes comparative prospective clinical trial. conditions: Acute Post Operative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 120 type: ACTUAL name: ketorolac and light marcaine name: light marcaine name: Corticosteroids injection name: Diclofenac Sodium Gel measure: age measure: sex measure: number of hemorrhoids measure: degree of hemorroids measure: post operative pain measure: ambulation measure: return to work measure: patient satisfaction sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Zagazig University Hospitals city: Zagazig zip: 44519 country: Egypt lat: 30.58768 lon: 31.502 hasResults: False

 nctId: NCT06307093 id: CL01860198 briefTitle: Study Comparing the Pharmacokinetics, Safety, and Efficacy of RPH-075 and Keytruda® in Patients With Malignant Neoplasms overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-01 date: 2023-12-11 date: 2025-07 date: 2024-03-12 date: 2024-03-12 name: R-Pharm class: INDUSTRY name: Data Management 365 name: Exacte Labs LLC name: Federal State Budgetary Institution "NMIC of Hematology" of the Ministry of Health of the Russian Federation name: Federal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor briefSummary: The goal of this double-blind, randomized study is to establish the equivalence of pharmacokinetic properties, as well as the comparability of safety, immunogenicity and pharmacodynamics of the drug RPH-075 (international nonproprietary name (INN) is pembrolizumab) in comparison with the drug Keytruda® (INN is pembrolizumab) after a single intravenous injection to patients with malignant neoplasms as a first or second line therapy in a monotherapy regimen.

The main main tasks are:

* To evaluate and compare the pharmacokinetic properties of RPH-075 and Keytruda® after a single intravenous administration of pembrolizumab to patients with malignant neoplasms;
* To evaluate the safety profile of the drug RPH-075 in comparison with the drug Keytruda® when used in patients with malignant neoplasms when used as a 1st or 2nd line therapy in a monotherapy regimen.

This study will also include a comparative assessment of immunogenicity, pharmacodynamic parameters and a pilot evaluation of RPH-075 efficacy. conditions: Skin Melanoma conditions: Squamous Non-small-cell Lung Cancer conditions: Head and Neck Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 90 type: ACTUAL name: RPH-075 name: Keytruda® measure: Area under the curve "concentration-time" (AUC(0-504)) of pembrolizumab measure: Incidence of Adverse Reactions (ARs) measure: Maximum Plasma Concentration (Cmax) of pembrolizumab measure: Maximum serum concentration of pembrolizumab at steady state (Сmax ss) measure: Minimal serum concentration of pembrolizumab at steady state (Сmin ss) measure: Area under the curve "concentration-time" of pembrolizumab at steady state (AUCtau ss) measure: Incidence of Treatment-Emergent Adverse Events (AEs) measure: Incidence of Immune-mediated adverse reactions (imARs) measure: Incidence of Treatment-Emergent AEs with grade 3 or more measure: Incidence of Treatment-Emergent ARs with grade 3 or more measure: Incidence of imARs with grade 3 or more measure: Incidence of serious adverse events (SAEs) measure: Incidence of serious adverse reactions (SARs) measure: The proportion of patients (%) who required therapy discontinuation due to AR development measure: The proportion of patients (%) who developed binding antibodies and neutralizing antibodies to pembrolizumab sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: State Budgetary Healthcare Institution of the city of Moscow "Moscow City Oncological Hospital No. 62 of the Department of Health of the City of Moscow" city: Istra state: Moscow Region zip: 143423 country: Russian Federation lat: 55.91997 lon: 36.86867 facility: "New Clinic" LLC city: Pyatigorsk state: Stavropol Territory zip: 357500 country: Russian Federation lat: 44.04861 lon: 43.05944 facility: Regional State Budgetary Healthcare Institution "Altai Regional Oncological Dispensary" city: Barnaul state: The Altai Republic zip: 656045 country: Russian Federation lat: 53.36056 lon: 83.76361 facility: Autonomous Institution of the Chuvash Republic "Republican Clinical Oncological Dispensary" of the Ministry of Health of the Chuvash Republic city: Cheboksary state: The Chuvash Republic zip: 428020 country: Russian Federation lat: 56.13222 lon: 47.25194 facility: State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the Ministry of Health of the Republic of Bashkortostan city: Ufa state: The Republic Of Bashkortostan zip: 450054 country: Russian Federation lat: 54.74306 lon: 55.96779 facility: State Budgetary Healthcare Institution of the Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary" city: Arkhangelsk zip: 163045 country: Russian Federation lat: 64.5401 lon: 40.5433 facility: Regional budgetary healthcare institution "Ivanovo Regional Oncological Dispensary" city: Ivanovo zip: 153040 country: Russian Federation lat: 56.99719 lon: 40.97139 facility: State Budgetary healthcare Institution "Kuzbass Clinical Oncological Dispensary named after M.S. Rappoport" city: Kemerovo zip: 650036 country: Russian Federation lat: 55.33333 lon: 86.08333 facility: State Budgetary Healthcare Institution of the city of Moscow "City Clinical Oncological Hospital No. 1 of the Department of Health of the City of Moscow" city: Moscow zip: 105005 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: State Budgetary Institution of Healthcare of the city of Moscow "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Department of Healthcare of the City of Moscow" city: Moscow zip: 111123 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation city: Moscow zip: 115478 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Federal State Budgetary Scientific Institution "Russian Scientific Center of Surgery named after Academician B.V. Petrovsky" city: Moscow zip: 119435 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University) city: Moscow zip: 119991 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Medsi Group of Companies JSC city: Moscow zip: 123056 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: "Research lab" LLC city: Moscow zip: 127521 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: State Budgetary Healthcare Institution of the Perm Territory "Perm Regional Oncological Dispensary" city: Perm zip: 614066 country: Russian Federation lat: 58.01046 lon: 56.25017 facility: State Budgetary Healthcare Institution Leningrad Regional Clinical Hospital city: Saint Petersburg zip: 188300 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Private healthcare institution "Clinical Hospital "Russian Railways-Medicine" of the city of St. Petersburg" city: Saint Petersburg zip: 195271 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: "Av Medical Group" LLC city: Saint Petersburg zip: 196006 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: St. Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary" city: Saint Petersburg zip: 197022 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Federal State Budgetary Institution "N.N. Petrov National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation city: Saint Petersburg zip: 197758 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: State Budgetary Healthcare Institution "Samara Regional Clinical Oncological Dispensary" city: Samara zip: 443031 country: Russian Federation lat: 53.20007 lon: 50.15 facility: The State Autonomous healthcare Institution of the Tyumen region "Multidisciplinary clinical Medical Center "Medical City" city: Tyumen zip: 625041 country: Russian Federation lat: 57.15222 lon: 65.52722 hasResults: False

 nctId: NCT06307080 id: IIT2023-064 briefTitle: Clinical Study of Multi-mode Thermal Ablation for the Treatment of Pancreatic Cancer With Liver Metastasis overallStatus: RECRUITING date: 2023-10-08 date: 2024-12-31 date: 2024-12-31 date: 2024-03-12 date: 2024-03-12 name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine class: OTHER briefSummary: 1. Clinical evaluation of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies.
2. Construction of a combined treatment system of multimodal ablation therapy combined with immunotherapy and chemotherapy.
3. Transformation and clinical application of multimodal ablation system for pancreatic cancer with hepatic metastatic malignancies. conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Multi-mode thermal ablation device name: Intravenous anti-PD-1 and chemotherapy measure: Safety and efficacy assessment measure: Survival benefit measure: The application of medical-mechanical combination therapy mode sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai General Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200040 country: China name: Jiang Long, MD role: CONTACT phone: +86 18017317460 email: jiang.long@shgh.cn lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06307067 id: URINDO briefTitle: Improving Care for Uncomplicated URinary Tract Infection-associated Symptoms in Primary Healthcare Settings in INDOnesia acronym: URINDO overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2024-11-04 date: 2025-06-01 date: 2024-03-12 date: 2024-03-12 name: Erasmus Medical Center class: OTHER name: Saiful Anwar Hospital name: Brawijaya University, Malang, Indonesia name: Diponegoro University/Diponegoro National Hospital, Semarang, Indonesia name: Bali Mandara Hospital, Denpasar, Bali, Indonesia briefSummary: In the present study, we aim to analyze the impact of the introduction of a urinary dipstick test for patients presenting with uncomplicated UTI-associated symptoms on antibiotic prescription in primary health care in Indonesia. In addition, the knowledge of HCW regarding antibiotics and prudent use of antibiotics in the community setting will be investigated.

Specific aims of the study:

1. To analyze the quality of antibiotic prescriptions for uncomplicated UTI in the primary health care settings in Indonesia, before introduction of urinary dipstick testing compared to after introduction of urinary dipstick testing.
2. To analyze the knowledge level of healthcare workers on uncomplicated UTI and prudent antibiotic use in primary health care settings in Indonesia. conditions: Urinary Tract Infections studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Urine dipstick measure: appropriateness of prescriptions for uncomplicated UTI-associated symptoms in the primary health care settings in Indonesia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus Medical Center city: Rotterdam state: Zuid-Holland zip: 3015 GD country: Netherlands lat: 51.9225 lon: 4.47917 hasResults: False

 nctId: NCT06307054 id: SHSY-CAR-NK-AML01 briefTitle: CLL-1 CAR-NK Cells for Relapsed/Refractory AML overallStatus: RECRUITING date: 2024-03-15 date: 2026-03-15 date: 2027-03-15 date: 2024-03-12 date: 2024-03-12 name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine class: OTHER briefSummary: This study is a single-arm, open-label, dose-escalation clinical trial aimed at exploring the safety, tolerability, and pharmacokinetic characteristics of the CLL-1 CAR NK cells, as well as providing preliminary observations on its efficacy in subjects with relapsed/refractory acute myeloid leukemia. conditions: Relapsed Adult AML conditions: Refractory AML studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: anti-CLL-1 CAR NK cells measure: AE measure: DLT measure: Peak Plasma Concentration (Cmax) measure: PD measure: Complete response measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Number of participants with treatment-related AEs as assessed by CTCAE v5.0 sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai General Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200080 country: China name: Xianmin Song, MD role: CONTACT phone: +86 21 63240090 phoneExt: 3175 email: shongxm@139.com name: Xianmin Song, MD role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06307041 id: OSATAGUN briefTitle: Effects of 0.2% Hyaluronic Acid Gel-Impregnated Dental Flosses on Clinical Gingival Parameters overallStatus: COMPLETED date: 2023-04-03 date: 2023-07-07 date: 2023-08-11 date: 2024-03-12 date: 2024-03-12 name: Özlem SARAÇ ATAGÜN class: OTHER briefSummary: This study aimed to evaluate the effects of 0.2% HA-impregnated dental flosses on the clinical periodontal parameters of patients with gingivitis. conditions: Gingivitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: single-center, single-blinded, split-mouth, randomized clinical trial primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The investigator who performed the measurements was blinded to which side of patients was the test group whoMasked: INVESTIGATOR count: 30 type: ACTUAL name: Dental floss+Gengigel name: Dental Floss measure: Clinical Periodontal Parameter-Gingival Index (GI) measure: Clinical Periodontal Parameter-Papillary Bleeding Index (PBI) measure: Clinical Periodontal Parameter-Plaque Index(PI) sex: ALL minimumAge: 18 Years maximumAge: 47 Years stdAges: ADULT facility: Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi city: Ankara zip: 06010 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06307028 id: Pro2023002116 id: K01DA050496 type: NIH link: https://reporter.nih.gov/quickSearch/K01DA050496 briefTitle: Sistas Informing Sistas on Topics About AIDS and Prevention (SISTA-P) acronym: SISTA-P overallStatus: RECRUITING date: 2024-01-08 date: 2024-07-01 date: 2024-08-31 date: 2024-03-12 date: 2024-03-12 name: Rutgers, The State University of New Jersey class: OTHER name: National Institutes of Health (NIH) name: National Institute on Drug Abuse (NIDA) briefSummary: In this project, the investigators will provide a new HIV prevention training and empowerment sessions to Black women in Washington D.C. who are at high risk for getting HIV. This training is tailored to the experience of Black women and seeks to reduce the high HIV transmission rates in the Black community. conditions: Health Behavior, Risky conditions: Health Knowledge, Attitudes, Practice conditions: Health-Related Behavior studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 30 type: ESTIMATED name: SISTA-P Intervention measure: Feasibility of the Intervention Scale measure: Acceptability of the Intervention Scale measure: Appropriateness of the Intervention Scale measure: Recruitment measure: Intervention Fidelity- participant characteristics measure: Intervention Fidelity measure: Acceptability of the intervention delivery measure: Participant Enrollment measure: Participant Retention measure: Feasibility of delivering 6 sessions in 6 weeks measure: Visual confirmation of self-reported PrEP uptake measure: Post-Intervention Follow-up sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Women's Collective status: ACTIVE_NOT_RECRUITING city: Washington state: District of Columbia zip: 20002 country: United States lat: 38.89511 lon: -77.03637 facility: Rutgers University status: RECRUITING city: New Brunswick state: New Jersey zip: 08854 country: United States name: Shawnika Hull, PhD role: CONTACT phone: 520-661-3300 email: shawnika.hull@rutgers.edu name: Shawnika Hull, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.48622 lon: -74.45182 hasResults: False

 nctId: NCT06307015 id: 2023/ETH02441 briefTitle: De-escalation of Radiation Dose in HPV-associated OPC Utilising FMISO PET (DE-RADIATE) acronym: DE-RADIATE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-12 date: 2031-12 date: 2024-03-12 date: 2024-03-12 name: Royal North Shore Hospital class: OTHER briefSummary: The goal of this prospective clinical trial is to determine if HPV-associated oropharyngeal squamous cell carcinoma that is non-hypoxic on FMISO PET can be successfully treated with a lower dose of radiation therapy.

The main questions it aims to answer are:

1. What is the pathologic complete response rate in patients selected for radiation dose de-escalation and neck dissection?
2. What is the correlation between MRI and FMISO PET assessment of hypoxia before and during RT?
3. What are the acute and late toxicities in patients selected for radiation dose de-escalation?
4. What are the quality of life scores in patients selected for radiation dose de-escalation?
5. What are the local, regional and distant failure rates of patients selected for radiation dose de-escalation?

Patients with cT1-2N1-2b (AJCC 7th edition) oropharyngeal tumours will undergo surgical resection of the primary tumour. Following this, they will be allocated to standard radiation therapy (70Gy with concurrent cisplatin chemotherapy) or de-escalation radiation therapy (30Gy with concurrent cisplatin chemotherapy) based on the results of FMISO PET. Patients with non-hypoxic tumours at baseline OR after two weeks of radiation therapy will be allocated to the de-escalated group. 3-4 months after completion of radiation therapy, all patients in the de-escalated group will undergo mandatory neck dissection to assess pathologic response.

Researchers will assess the pathologic response rate after surgery in the de-escalation group. They will also compare the outcomes (oncological outcomes and quality of life) between the group receiving the standard treatment (70Gy) and the group receiving de-escalated radiation therapy (30Gy). conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: De-escalation name: Standard of care measure: Pathologic complete response measure: Correlation between MRI and FMISO PET assessment of hypoxia measure: Quality of Life of patients undergoing de-escalation radiation therapy measure: Quality of Life of patients undergoing de-escalation radiation therapy measure: Local control measure: Regional control measure: Distant metastases measure: Acute toxicities measure: Late toxicities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northern Sydney Cancer Centre, Royal North Shore Hospital city: Saint Leonards state: New South Wales zip: 2065 country: Australia name: Carol Kwong role: CONTACT phone: 9463 1300 email: carolyn.kwong@health.nsw.gov.au name: Anna Lawless role: PRINCIPAL_INVESTIGATOR name: Sarah Bergamin role: PRINCIPAL_INVESTIGATOR lat: -33.82344 lon: 151.19836 hasResults: False

 nctId: NCT06307002 id: CAS_EB_2024 briefTitle: Evaluating What's My Method? in Barbados overallStatus: RECRUITING date: 2024-03-11 date: 2024-06-15 date: 2024-07-30 date: 2024-03-12 date: 2024-03-15 name: Quinnipiac University class: OTHER name: Barbados Family Planning Association briefSummary: The purpose of this study is to measure the impact of the What's My Method game on participants' sense of agency, education, and empowerment around contraceptive decision-making. Patients receiving standard of care contraceptive counseling will be compared to those who play the game in addition to counseling. conditions: Contraception Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a 2 arm randomized controlled trial comparing standard of care (SOC) counseling alone to What's My Method? (WMM) gameplay in addition to SOC. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 70 type: ESTIMATED name: Playing a contraception education videogame measure: Contraceptive Self-Efficacy (CSE) score measure: Method Adoption measure: Qualitative feedback on game intervention sex: FEMALE minimumAge: 18 Years maximumAge: 48 Years stdAges: ADULT facility: Barbados Family Planning Association status: RECRUITING city: Bridgetown state: Saint Michaels zip: BB11085 country: Barbados name: Anderson Langdon, MA role: CONTACT phone: 2462336750 email: anderson@bfpaonline.com name: Tiffany Jordan, MD role: CONTACT phone: 2468324827 email: tiffany@bfpaonline.com name: Tiffany Jordan, MD role: SUB_INVESTIGATOR lat: 13.10731 lon: -59.62021 hasResults: False

 nctId: NCT06306989 id: Zhengzhou University briefTitle: Observational Clinical Study of Letermovir for Preventing CMV Infection After Allo-HSCT overallStatus: RECRUITING date: 2023-01-01 date: 2024-09-01 date: 2025-12-01 date: 2024-03-12 date: 2024-03-12 name: Cao Weijie class: OTHER briefSummary: The goal of this observational study is to get a series of clinical data related to the prevention of CMV infection after allo-HSCT with letemovir. The main question it aims to answer are:

* Efficacy and safety of letemovir for the prevention of CMV infection after allo-HSCT.
* Optimal initiation of letemovir to prevent CMV infection. Participants will be categorized into high-risk and intermediate-risk groups based on risk factors for CMV infection.Initiate letemovir prophylaxis on day +1 in high-risk patients and on days +7 to +14 in non-high-risk patients.(240 mg, qd in patients with concomitant cyclosporine; 480 mg, qd in patients with concomitant tacrolimus) to +100 days. For patients with comorbid GVHD who require intensive immunosuppression, consider extending the regimen to +200 days.Treatments they will be given and use bullets. conditions: Letemovir for the Prevention of CMV Infection After Allo-HSCT studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Letermovir measure: Prevalence of CMV viremia and CMV disease within 100 days after allogeneic hematopoietic stem cell transplantation. measure: +30-day CMV viremia, CMV disease; +30-day overall survival, non-relapse mortality; +30-day relapse rate; +30-day aGVHD incidence. measure: +100-day overall survival, non-relapse mortality; + 100-day relapse rate; + 100-day aGVHD incidence. measure: +180-day CMV viremia, CMV disease; +30-day overall survival, non-relapse mortality; +180-day relapse rate; +180-day aGVHD incidence. sex: ALL minimumAge: 14 Years maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Cao, Weijie status: RECRUITING city: Zhengzhou state: Henan zip: 450000 country: China name: Weijie W Cao, doctor of medicine role: CONTACT phone: +8618937390269 email: 2549509184@qq.com name: Mengyang M Zhu, Postgraduate medical students role: CONTACT phone: +8615093360671 phoneExt: 0371-66913114 email: Caoweijie2003@126.com lat: 34.75778 lon: 113.64861 hasResults: False

 nctId: NCT06306976 id: 2066031 briefTitle: Shear-Wave Elastography acronym: ELASTOGRAPHY overallStatus: ENROLLING_BY_INVITATION date: 2024-03 date: 2024-07 date: 2025-08 date: 2024-03-12 date: 2024-03-13 name: Prisma Health-Upstate class: OTHER briefSummary: Prospective cohort study of patients with midline ventral incisional hernia with a range of hernia morphology who plan to undergo open retromuscular VHR.

Study groups: Study groups are selected across a range of morphology and based on factors known or suspected to affect the ability to achieve fascial closure.

Control groups: The study plans to enlist 5 volunteers with no incisional hernia or prior laparotomy to establish internal baseline SWE values and interrater reliability. The study will also plan to recruit 5 patients undergoing primary laparotomy in order to correlate SWE findings with closure tension. conditions: Ventral Incisional Hernia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Specific Aim 1:

Determine the elasticity of abdominal wall muscles (rectus abdominis, external oblique, internal oblique, and transversus abdominis) through shear wave elastography in patients with midline incisional hernias of varying complexity and morphology.

Specific Aim 2:

Correlate shear wave elastography measurements of the abdominal wall with the extent of MFR required to achieve fascial closure.

Specific Aim 3:

Correlate SWE-determined elasticity of abdominal wall to intraoperative assessment of tension required to achieve fascial closure. primaryPurpose: OTHER masking: NONE count: 70 type: ESTIMATED name: Elective Midline Laparotomy name: Imaging: Ultrasound name: Tensiometry measure: Determine Elasticity of Abdominal Wall Muscles (Specific Aim 1) measure: Correlate Elastography measurements with MFR (Specific Aim 2) measure: Correlate SWE Assessment to Tensiometer (Specific Aim 3) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prisma Health city: Greenville state: South Carolina zip: 29615 country: United States lat: 34.85262 lon: -82.39401 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-06-01 uploadDate: 2024-03-11T16:32 filename: Prot_000.pdf size: 301771 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2023-07-12 uploadDate: 2024-03-11T16:33 filename: SAP_001.pdf size: 170975 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-07-12 uploadDate: 2024-03-11T16:33 filename: ICF_002.pdf size: 179351 hasResults: False

 nctId: NCT06306963 id: 23-004669 briefTitle: Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias acronym: GAVE overallStatus: RECRUITING date: 2024-03-22 date: 2026-03-01 date: 2026-09-01 date: 2024-03-12 date: 2024-04-26 name: Mayo Clinic class: OTHER briefSummary: The researchers are trying to find out more about Gastric Antral Vascular Ectasia (GAVE). This is a condition that affects the blood vessels in the stomach, leading to their enlargement and possible bleeding. It can also cause symptoms such as abdominal pain and nausea. By participating in this study, you will help us learn how often these symptoms occur and how they relate to stomach functioning. conditions: Gastric Antral Vascular Ectasia conditions: Cirrhosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Gastric Emptying measure: Abridged Bowel Disease Questionnaire measure: Nepean Dyspepsia Index measure: Leuven Postprandial Distress Scale measure: Gastric Emptying Half Time (T 1/2) of Solids measure: Gastric Emptying Half Time (T 1/2) of liquids sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Taylor N Hines role: CONTACT phone: 507-538-9959 email: hines.taylor@mayo.edu name: Anjali Rajagopal, MBBS role: CONTACT phone: 507-266-8779 email: Rajagopal.Anjali@mayo.edu name: Xiao Jing Wang, MD role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06306950 id: PMK-00098 briefTitle: Prioritization of Cerebral Deoxygenation in Severe Traumatic Brain Injury and Mortality Benefit. overallStatus: COMPLETED date: 2021-04-01 date: 2024-02-28 date: 2024-02-28 date: 2024-03-12 date: 2024-03-15 name: Phramongkutklao College of Medicine and Hospital class: OTHER briefSummary: Severe traumatic brain injury with a decrease in cerebral oximetry is associated with multiple impaired systemic microcirculations, more morbidities, and a higher mortality rate. When using the brain as an index organ, interventions to improve brain oxygen delivery may have systemic benefits for these patients. conditions: Cerebral Hypoxia conditions: Severe Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In a prospective study, 80 patients were randomized to either application of near-infrared reflectance spectroscopy (NIRS) monitoring with active display or attempt to make an intervention to keep regional cortical cerebral oxygen saturation (rSO2) ≥ 55% by increased cardiac output, mean arterial pressure, and adjusting the ventilator to hypoventilation (PaCO2 40-45 mmHg) (exclude in radiographic brain herniation) (intervention, n = 40), compared with usual care (n = 40). Clinical outcomes were assessed by a blind observer. Data collection comprised of patients' demographic data, intervention process, and outcomes of treatment assessed by modified Rankin scale (mRS) followed up at 1 year. primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Upon arrival in the emergency department, the randomization envelope was opened, and patients were assigned into either active treatment (intervention) or usual care (control) groups with cerebral oximetry monitoring using NIRS bilaterally (Root; Prime Medical Corporation, MASIMO, USA). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 80 type: ACTUAL name: Near infrared spectroscopy neuromonitor to prevent cerebral desaturation measure: modified Rankin scale (mRS) followed up at 1 year sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Phramongkutklao College of Medicine and Hospital city: Bangkok zip: 10400 country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06306937 id: A24020822 briefTitle: Serum Levels of Vitamin D and IL8 in Patients With Periodontitis overallStatus: COMPLETED date: 2022-09-01 date: 2023-09-30 date: 2023-09-30 date: 2024-03-12 date: 2024-03-12 name: Mansoura University class: OTHER briefSummary: We evaluated vitamin D and IL8 levels in the serum of patients with periodontitis as well as the healthy controls to correlate their levels with the degree of periodontitis. conditions: Periodontal Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 98 type: ACTUAL name: Evalution of serum levels of vitamin D and IL8 measure: Serum Levels of 25(OH)vitamin D measure: Serum Levels of IL8 measure: Plaque Index (Pl) measure: Clinical Attachment Loss (CAL) measure: Probing Pocket Depth (PPD) sex: ALL minimumAge: 21 Years maximumAge: 55 Years stdAges: ADULT facility: Mansoura University, Faculty of Dentistry city: Mansoura state: Dakahlia zip: 35516 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06306924 id: LCCC2303 briefTitle: UNC Metastatic Cancer Radiation Therapy Registry overallStatus: RECRUITING date: 2024-04-21 date: 2033-05 date: 2033-05 date: 2024-03-12 date: 2024-04-26 name: UNC Lineberger Comprehensive Cancer Center class: OTHER briefSummary: The purpose of this registry is to collect clinical data from participants attending UNC Hospitals who present with metastatic cancer and are evaluated to receive radiation therapy as part of their standard of care treatment. The goal of this study is to provide a foundation for studies designed to identify projects across the translational continuum related to metastatic cancer and radiation therapy treatment. The relevant clinical data will be linked to patient-reported outcomes (PROs) thus allowing for a unique and robust dataset. Ultimately, this registry will provide current and future studies with the ability to analyze the correlation of radiation therapy regimens with metastatic cancer outcomes. conditions: Cancer conditions: Metastatic Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: Radiation therapy measure: Clinical Data measure: Patient reported outcomes (PRO) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill status: RECRUITING city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Shivani Sud, MS role: CONTACT phone: 919-918-5924 email: sshivani.sud@unchealth.unc.edu name: Shivani Sud, MD role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06306911 id: BB-BAM briefTitle: Bioavailability of Aronia Melanocarpa overallStatus: RECRUITING date: 2024-03 date: 2024-07 date: 2024-07 date: 2024-03-12 date: 2024-03-12 name: Maastricht University Medical Center class: OTHER name: BioActor briefSummary: The main objective of this study is to study the bioavailability and kinetics of acute Aronia Melanocarpa supplementation in healthy young (18-35 years) and older adults (55-75 years) adults. During the test day, participants will ingest a drink consisting of Aronia Melanocarpa extract (AME). The bioavailability and kinetics of AME will be assessed via frequent blood sampling, urine collection, and faecal sampling, in which AME and metabolite profiles will be quantified. conditions: Bioavailability conditions: Kinetics studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 16 type: ESTIMATED name: Aronia Melanocarpa extract measure: Aronia metabolites in blood measure: Aronia metabolites in urine measure: Aronia metabolites in feces measure: length - baseline characteristics measure: weight - baseline characteristics measure: blood pressure (systolic and diastolic) - baseline characteristics sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maastricht University status: RECRUITING city: Maastricht country: Netherlands name: Sanne Ahles, Msc role: CONTACT email: s.ahles@maastrichtuniversity.nl name: Jogchum Plat, Prof role: CONTACT lat: 50.84833 lon: 5.68889 hasResults: False

 nctId: NCT06306898 id: IAV-2024-01 briefTitle: Intra-Arrest-Ventilation in Human Cadavers overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2024-10-31 date: 2024-12-31 date: 2024-03-12 date: 2024-03-19 name: Gerrit Jansen class: OTHER name: Ruhr University of Bochum name: Bielefeld University briefSummary: The study investigates the influence of non-synchronized bag-device-ventilation and intermittent positive pressure ventilation (IPPV), as recommended in the current resuscitation guidelines of the European Resuscitation Concil (tidal Volume (Vt) = 5-6 mL/kg body weight, respiratory rate = 10 min-1) and Chest Compression Synchronized Ventilation (pInsp = 40 mbar; respiratory rate = chest compression rate) with regard to achieving a sufficient tidal volume and the tightness of various supraglottic airway devices (laryngeal mask, i-Gel-laryngeal mask, laryngeal tube) and endotracheal intubation. conditions: Cardiac Arrest studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized crossover design primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Endotracheal Intubation name: Laryngeal tube name: Laryngeal mask name: I-Gel-Laryngeal Mask measure: Expiratory Volume with different Airway Devices in IPPV measure: Ventilation Pressure with different Airway devices in CCSV sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06306885 id: CLF23/03 briefTitle: Effects of Early Sleep After Action Observation and Motor Imagery After Metacarpal Fracture Surgery overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-09-01 date: 2025-05-01 date: 2024-03-12 date: 2024-03-12 name: Istituto Clinico Humanitas class: OTHER briefSummary: The study aimed to investigate the effects of early sleep after action observation and motor imagery (AOMI) training sessions on manual dexterity in patients with hand immobilization after surgical fixation for metacarpals and phalanges fractures.

Fifty-one patients with hand immobilization for surgical fixation of IV or V metacarpals or first phalanges fractures will be randomized into AOMI-sleep (n=17), AOMI-control (n=17), and Control (n=17) group. AOMI-sleep and AOMI-control groups will perform an AOMI-training before sleeping or in the morning respectively, while Control group will be asked to observe landscape video-clips. Participants will be assessed for manual dexterity, hand range of motion, hand disability and quality of life at baseline before and after the training and at 1 month after the training end. conditions: Hand Injuries conditions: Action Observation conditions: Motor Imagery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 51 type: ESTIMATED name: Action observation plus motor imagery followed by sleep name: Action observation plus motor imagery name: Control measure: Changes in Purdue Pegboard Test measure: Changes in kinematic indexes during Nine Hole Peg Test measure: Changes in Visual Analogue Scale measure: Changes in Quick-DASH measure: Changes in EQ5D measure: Changes in Total Active Motion measure: Hand-grip strength sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06306872 id: ABSK-011-102 briefTitle: A Clinical Trial to Evaluate the Relative Bioavailability of New and Old ABSK-011 Capsules overallStatus: RECRUITING date: 2024-02-23 date: 2024-12-31 date: 2024-12-31 date: 2024-03-12 date: 2024-03-12 name: Abbisko Therapeutics Co, Ltd class: INDUSTRY briefSummary: The main objective of which is to evaluate the relative bioavailability and PK characteristics of new and old ABSK-011 capsules in a single oral dose conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will be randomly assigned 1:1 to arms A (Sequence A) or arms B (Sequence B) to receive a single dose of ABSK-011 orally in two separate doses, spaced at least 4 days apart. Among them, subjects in sequence A will be given ABSK-011 220 mg (100 mg capsule \*2 and 20 mg capsule \*1) and ABSK-011 200 mg (100 mg capsule \*2) on an empty stomach in the morning of the first day of cycle 1 (C1D1) and the first day of cycle 2 (C2D1), respectively. Subjects in sequence B will be given ABSK-011 new formulation 200 mg (100 mg capsule \*2) and ABSK-011 old formulation 220 mg (100 mg capsule \*2 and 20 mg capsule \*1) on an empty stomach in the morning of Cycle 1 day (C1D1) and cycle 2 day (C2D1), respectively. primaryPurpose: OTHER masking: NONE count: 73 type: ESTIMATED name: Sequence A ABSK-011 name: Sequence B ABSK-011 measure: Cmax measure: AUC measure: tmax measure: AEs measure: SAEs SAEs measure: t1/2 measure: Vz/F measure: CL/F CL/F sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Affiliated Hospital of Jiangnan University status: RECRUITING city: Wuxi state: Jiangsu zip: 214062 country: China name: Yiqing Zhao role: CONTACT phone: 13358100007 email: 13358100007@126.com lat: 31.56887 lon: 120.28857 hasResults: False

 nctId: NCT06306859 id: SIKIDI 2024 briefTitle: Development of Health Monitoring System on Patient's Well Being in Dialysis Context acronym: SIKIDI overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-10-31 date: 2024-12-31 date: 2024-03-12 date: 2024-03-12 name: Universitas Muhammadiyah Yogyakarta class: OTHER name: Ministry of Education Culture, Research and Technology briefSummary: One of the goals in the Sustainable Development Goals (SDGs) is the availability of a healthy and prosperous life for all ages. This goal mentions health priorities i.e. non-communicable diseases. Chronic kidney failure (CRF) is one of the non-communicable diseases that is the main cause of death and disability both in the world and in Indonesia. The prevalence of CRF in Indonesia is 0.5% with 83.2% of patients being of productive age and the highest number of CRF patients in North Kalimantan, Southeast Sulawesi, DKI Jakarta and Yogyakarta. Monitoring and evaluation of patients with CRF is currently mostly carried out conventionally not using health technology that is integrated with hospital information systems. This study aims to design and provide a health information system for patients with CRF, hereinafter referred to as SIKIDI, which integrates mobile-health applications used independently by patients with existing information systems in hospitals. conditions: Quality of Life conditions: Self Efficacy conditions: Chronic Kidney Diseases conditions: M-health studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The intervention group will be given access to m-health to monitor and education provision for about four weeks primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The sample will be divided based on the schedule of hemodialysis. Intervention group will be chosen from Monday-Thursday. whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Using m-health for monitoring and education provision name: Standard care measure: Quality of Life that will be measured using KDQOL before and after intervention measure: Self-efficacy that will be measured using CKD SE before and after sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RS PKU Muhammadiyah Bantul city: Bantul state: Yogy zip: 55183 country: Indonesia name: Indra Prasetyantori, Master role: CONTACT lat: -7.88806 lon: 110.32889 hasResults: False

 nctId: NCT06306846 id: 11235794 briefTitle: Neoadjuvant SBRT in Localized Advanced HNSCC overallStatus: RECRUITING date: 2023-10-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-12 date: 2024-03-12 name: Jiang Feng class: OTHER briefSummary: The response rate of HNSCC to immune checkpoint blockade was not satisfied. Improving the mPR rate of neoadjuvant immunotherapy through the combination with other treatment methods is an important way to further improve the prognosis of such patients. This study aims to explore the efficacy and safety of PD-1 monoclonal antibody with neoadjvant SBRT and chemotherapy. The triple mode not only can Increase the effectiveness of neoadjuvant therapy，meanwhile，the in situ tumor vaccine inoculation effect generated by enhancing the release of specific antigens after tumor radiotherapy with PD-1 monoclonal antibody achieves a sustained anti-tumor immune effect throughout the body， reducing postoperative adjuvant radiotherapy and chemotherapy. The triple mode has important exploratory value in achieving high quality and long-term survival for patients, and may provides a more efficient mode for locally advanced HNSCC. conditions: Head and Neck Squamous Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 81 type: ESTIMATED name: SBRT+immunochemotherpy name: Immunochemotherapy name: cetuximab+immunochemotharpy measure: major pathology response (MPR) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Cancer Hospital status: RECRUITING city: Hangzhou state: Zhejiang zip: 310022 country: China name: Feng Jiang, MD role: CONTACT phone: 0086-571-88128202 email: jiangfeng@zjcc.org.cn lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06306833 id: CLBP-sEMG-14022024 briefTitle: The Surface EMG Biofeedback as an Alternative Therapy to Reduce Chronic Low Back Pain overallStatus: RECRUITING date: 2023-10-01 date: 2024-05 date: 2024-12 date: 2024-03-12 date: 2024-03-12 name: Amaila Fazal [afazal] class: OTHER name: University of Karachi briefSummary: The prevalence of chronic low back pain (CLBP) among the Pakistani population is reported to be as high as 78% leading towards different physiological and psychosocial alterations with the worst cases suffering from disabilities. CLBP is a multifactorial phenomenon in which age, gender, comorbidities, lifestyle conditions, profession, working hours, and different stressors play their roles in its causation. However, different therapeutic techniques have been determined to reduce CLBP. Thus, this study aimed to assess the effectiveness of the biofeedback surface EMG (sEMG) technique in reducing chronic low back pain among sufferers in the long run. conditions: Chronic Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 200 type: ESTIMATED name: Surface Electromyography (sEMG) Biofeedback measure: Pain Intensity and interference measure: Lower back pain related Disability measure: Quality of Life with chronic low back pain measure: Pain and Disability-related Anxiety measure: Substance P measure: Cortisol measure: Beta Endorphins sex: ALL minimumAge: 25 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Psychophysiology Lab, University of Karachi status: RECRUITING city: Karachi state: Sindh zip: 75270 country: Pakistan name: Shamoon Naushad, PhD role: CONTACT phone: 03333549258 lat: 24.8608 lon: 67.0104 hasResults: False

 nctId: NCT06306820 id: 36264MS257/7/2023 briefTitle: Ultrasound Guided Recruitment Manauvere Versus Individualized Positive End Expiratory Pressure in Pediatric Patients Undergoing Laparoscopic Abdominal Surgery overallStatus: RECRUITING date: 2024-03-12 date: 2024-08-01 date: 2024-08-01 date: 2024-03-12 date: 2024-03-13 name: Tanta University class: OTHER briefSummary: The aim of this prospective randomized controlled study is to compare the effect of US-guided Recruitment Manauvere (RM) versus individualized positive end-expiratory pressure (PEEP) on oxygenation and preventing respiratory complications in pediatric patients undergoing laparoscopic abdominal surgeries. conditions: Ultrasound Guided Recruitment Manauvere conditions: End Expiratory Pressure conditions: Pediatric Patients conditions: Laparoscopic Abdominal Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: Fixed PEEP name: Ultrasound-guided lung recruitment name: Individualized PEEP measure: Intraoperative oxygenation measure: Lung ultrasound scores measure: Mean arterial blood pressure (MAP) measure: Heart rate measure: Postoperative pulmonary complication sex: ALL minimumAge: 3 Years maximumAge: 8 Years stdAges: CHILD facility: Tanta University status: RECRUITING city: Tanta state: El-Gharbia zip: 31527 country: Egypt name: Reham M Rezk, MBBCH role: CONTACT phone: 00201013193723 email: rehamrezk95@gmail.com name: Soher M Soliman, MD role: SUB_INVESTIGATOR name: Shaimaa F Abdelkader, MD role: SUB_INVESTIGATOR name: Shaimaa E Shaban, MD role: SUB_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06306807 id: AtlasUmkaya02 briefTitle: Investigation of the Effectiveness of Proprioceptive Neuromuscular Facilitation Techniques in Text Neck Syndrome overallStatus: COMPLETED date: 2023-12-31 date: 2024-03-14 date: 2024-03-15 date: 2024-03-12 date: 2024-03-15 name: Atlas University class: OTHER briefSummary: Smartphones and tablets are increasingly widespread mobile technological devices used for many purposes such as communication, transportation, entertainment, education and security. Increasing use of mobile technology leads to various symptoms such as insomnia, difficulty concentrating and anxiety, especially musculoskeletal problems. "Text neck" is a musculoskeletal problem seen in individuals who use smartphones and tablets for a long time due to increased head and neck flexion posture. It causes neck, back, shoulder, and head pain, insomnia, tingling and numbness in the hands. Implementation of exercise programs for both preventive and therapeutic purposes is one of the main goals in this picture dominated by posture and pain problems. Proprioceptive neuromuscular facilitation (PNF) treatment technique; In the 1940s by H. Kabat and M. Knott, PNF was expressed as a means of facilitating neuromuscular responses by stimulation of proprioceptors. It is stated that it increases joint stabilization, strength, normal range of motion, endurance and circulation and is effective in improving coordination. Although PNF techniques have been used for different spinal problems, there is no study investigating PNF techniques in text neck syndrome. The study was aimed to compare the effect of a method including muscle relaxation in the anterior elevation direction and repetition techniques in the posterior depression direction from PNF neck patterns on pain intensity, neck normal range of motion, neck muscle endurance, posture and functionality in individuals with text neck syndrome with another method including ergonomic adjustments and simple cervical exercises recommended in the literature to be included in standard treatment. conditions: Neck Muscle Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 38 type: ACTUAL name: Exercise program including active cervical range of motion, strengthening, and posture correction exercises and ergonomic modifications name: PNF exercise program measure: Pain intensity measure: Cervical range of motion measure: Neck flexor-extensor muscle endurance test measure: Posture measure: Disability sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Istanbul Atlas University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06306794 id: 2011-KAEK-25 2023/12-26 briefTitle: Reducing Pain Levels and Increasing Comfort of Premature Infants During Aspiration overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-03-12 date: 2024-03-12 name: Nurgül Tekin class: OTHER briefSummary: The aim of this study was to investigate the effect of using amigurumi octopus on the pain and comfort of the newborn in premature infants undergoing endotracheal aspiration.

It is a randomized controlled quasi-experimental design. The study will be conducted in the neonatal intensive care unit of Health Sciences University Bursa High Specialization Training and Research Hospital. The population of the study will consist of preterm hospitalized in the neonatal intensive care unit during the period of the conducted study. In the calculation of the sample size, the power level is 80% and the significance level is 5%. It was determined by the statistical expert that the number of babies that should be included for each group is 26 and the total number of babies required for the whole study is 52 when the effect size is determined as 0.8 for the investigation of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable. Based on aforementioned information, the study sample was determined as 80 preterm infants in which 40 for experimental groups and 40 for control groups. Block randomization method will be applied for the randomization of the groups.

PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used as a case report form for the collection of the study data. All the patients included in the study will be intervened by the nurse having a neonatal nursing experience by paying attention to aseptic conditions in accordance with the routine aspiration criteria of the unit. Standardization will be ensured by intervening in all patients with the same application by the same nurse.

During the endotracheal aspiration procedure, the octopus will be given to experimental group 10 minutes before the procedure. Babies will be allowed to touch the octopus for 10 minutes during and after the procedure. Physiologic parameters of the infants before, during and after the procedure will be reported and recorded by camera. According to the video recordings, PIPP-R and PICS scale evaluations of the infants will be made by two research nurses other than the main researcher conducting the study. The routine aspiration application steps of the unit will be applied to the control group without any intervention. conditions: Pain conditions: Premature Baby 26 to 32 Weeks conditions: Premature Baby 33 to 36 Weeks conditions: Aspiration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In the calculation of the sample size, the power level is 80% and the significance level is 5%. It was determined by the statistical expert that the number of babies that should be included for each group is 26 and the total number of babies required for the whole study is 52 when the effect size is determined as 0.8 for the investigation of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable. Based on aforementioned information, the study sample was determined as 80 preterm infants in which 40 for experimental groups and 40 for control groups. Block randomization method will be applied for the randomization of the groups. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: crochet octopus measure: pain in the during endotracheal aspiration measure: comfort in the during endotracheal aspiration sex: ALL minimumAge: 1 Day maximumAge: 5 Days stdAges: CHILD hasResults: False

 nctId: NCT06306781 id: HI-IM-002 briefTitle: A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of HCL001 Cell Injection (Homologous Allogeneic Hepatocytes) in Patients With Decompensated Cirrhosis overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2026-07-30 date: 2026-12-30 date: 2024-03-12 date: 2024-03-12 name: RenJi Hospital class: OTHER briefSummary: This study protocol is designed to evaluate the clinical efficacy, safety, and tolerability of HCL001 cell injection in the treatment of decompensated cirrhosis. The aim is to provide stronger evidence for the clinical application of HCL001 cell injection in the treatment of decompensated cirrhosis, thereby attempting to improve patients' survival and quality of life to meet the clinical needs for treating decompensated liver cirrhosis. conditions: Decompensated Cirrhosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: HCL001 cell (homologous allogeneic hepatocytes) injection measure: Types and incidence of treatment-related adverse events. measure: Dose-Limiting Toxicity (DLT) measure: Maximum Tolerated Dose (MTD) measure: Child-Pugh grading. measure: Number of participants with abnormal laboratory tests results measure: The percentage of participants with improved liver conditions (including changes in portal vein diam sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06306768 id: STU00219979 briefTitle: Remote Therapeutic Monitoring Exercise Tracking overallStatus: RECRUITING date: 2024-04-01 date: 2028-03 date: 2028-03 date: 2024-03-12 date: 2024-04-16 name: Shirley Ryan AbilityLab class: OTHER briefSummary: The purpose of this study is to examine physical activity and exercise behaviors in people with Parkinson's Disease and Multiple Sclerosis over the course of 1-year using a cloud-based remote monitoring platform. conditions: Parkinson Disease conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 200 type: ESTIMATED name: Activity Monitoring measure: Physical Activity Metric 1 measure: Physical Activity Metric 2 measure: Exercise Self Efficacy measure: Quality of Life from PROMIS 10-b measure: Quality of Life from PROMIS-29 sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shirley Ryan AbilityLab status: RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Hannah Redd, DPT role: CONTACT email: hredd@sralab.org name: Kristen Hohl, DPT role: CONTACT email: khohl@sralab.org lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06306755 id: 2021YFC2500405 briefTitle: Effectiveness of Risk-based Sequential Screening for Esophageal and Gastric Cancer acronym: ERSS-EGC overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-12 date: 2034-12 date: 2024-03-12 date: 2024-04-16 name: Peking University Cancer Hospital & Institute class: OTHER briefSummary: To evaluate the feasibility, applicability, effectiveness, and health-economic value of the risk-based sequential screening modality for esophageal and gastric cancers, the investigators aim to initiate a community-based randomized controlled trial in Xun County, Henan Province, which is a high-risk region of upper gastrointestinal cancer (UGIC) in northern China.

A total of 258 target villages from all the 11 communities (townships and streets) in Xun County will be randomly selected and assigned to the sequential screening group and the universal screening group at a ratio of 2:1 and the total sample size will be 21,000.

In the sequential screening group, participants in the top 50% risk level (i.e., stratified as the high-risk subgroup) will be offered a standard upper gastrointestinal endoscopic screening. In contrast, all participants in the universal screening group will receive the endoscopic examination. The surveillance strategy for participants with screening-detected premalignant lesions in the sequential screening group will be tailored based on individualized risk assessment using endoscopic characteristics, pathological diagnosis, and biomarkers. Surveillance for participants in the universal screening group will adhere to current guidelines for UGIC screening and clinical treatment.

Detection rates of upper gastrointestinal malignant lesions, early-stage malignant lesions and premalignant lesions, and health-economic indicators such as the unit cost per detected malignant lesions will be compared between the two groups. conditions: Esophageal Cancer conditions: Gastric Cancer conditions: Precision Screening conditions: Sequential Screening conditions: Risk Stratification studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 21000 type: ESTIMATED name: Risk Assessment and Individualized Surveillance name: Universal screening measure: Detection rate of upper gastrointestinal (esophageal/gastric) malignant lesions measure: Rate of early-stage upper gastrointestinal (esophageal/gastric) malignant lesions measure: Detection rate of upper gastrointestinal (esophageal/gastric) premalignant lesions measure: Response rate of endoscopic examination measure: Total screening costs measure: Unit cost per detected upper gastrointestinal (esophageal/gastric) malignant lesions measure: Unit cost per detected early-stage upper gastrointestinal (esophageal/gastric) malignant lesions measure: Unit cost per detected upper gastrointestinal (esophageal/gastric) premalignant lesions measure: Satisfaction with the risk-based sequential screening modality measure: Rate of timely treatment measure: UGIC-specific mortality measure: All-cause mortality measure: Quality of life Scale Score sex: ALL minimumAge: 50 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of genetics, Peking University Cancer Hospital & Institute city: Beijing state: Beijing zip: 100142 country: China name: Zhonghu He role: CONTACT email: zhonghuhe@bjcancer.org name: Zhonghu He, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06306742 id: ct9874 briefTitle: Open-label Placebo in Manual Therapy overallStatus: RECRUITING date: 2024-02-26 date: 2025-12 date: 2026-06 date: 2024-03-12 date: 2024-03-12 name: Studio Osteopatico Busto Arsizio class: OTHER briefSummary: to investigate the effects of placebo in patients affected by low-back pain. conditions: Low Back Pain, Recurrent studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Open-label placebo name: Osteopathic manipulative treatment measure: Change in Numeric Rating Scale measure: Adverse effects measure: Change in measures of Von Frey filaments measure: Changes in algometer measurements sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CTFO status: RECRUITING city: Saronno state: Varese zip: 21047 country: Italy name: CFTO role: CONTACT phone: +39 02 96701013 email: cfto@aimoedu.it lat: 45.62513 lon: 9.03517 hasResults: False

 nctId: NCT06306729 id: 316308 briefTitle: Computational Assessment of Bioprosthetic Aortic Valve Function overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2026-04-01 date: 2024-03-12 date: 2024-03-12 name: Royal Brompton & Harefield NHS Foundation Trust class: OTHER name: Edwards Lifesciences name: Imperial College London briefSummary: Bioprosthetic valves are usually made of biological tissue that are mounted to a frame and are designed to function similarly to a healthy natural valve. Edwards Magna Ease and Intuity Elite bioprosthetic valves have similar leaflets and mounting designs. However, the valves are implanted in the patient in different ways (one is stitched to the wall of the left ventricular outflow tract, and the other is held in place by the radial force of the valve skirt). The study aims to understand in more detail how the different valves interact with the left ventricular outflow tract and aortic root. conditions: CFD conditions: Valve Heart Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Computed Tomography, Magnetic Resonance Imaging measure: blood flow velocities measure: Time average wall shear stress (TAWSS) measure: Patient's satisfaction measure: Evidence of major adverse cardiac and cerebrovascular events (MACCE) measure: Mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06306716 id: LEO.2021.10 briefTitle: Single Center Clinical Study on New Negative Pressure Wound Therapy Dressing in the Management of Chronic & Acute Wounds overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2025-04-30 date: 2025-04-30 date: 2024-03-12 date: 2024-03-12 name: Smith & Nephew, Inc. class: INDUSTRY briefSummary: The purpose of the study is to evaluate the clinical performance of a new Negative Pressure Wound Therapy dressing in the management of chronic and acute wounds. conditions: Chronic Wounds conditions: Acute Wounds studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 23 type: ESTIMATED name: RENASYS Film with AIRLOCK Technology measure: Wound Healing Status measure: Percentage Reduction in Wound Volume from Baseline to Week 3 measure: Percentage Reduction in Wound Area from Baseline to Week 3 measure: Percentage Reduction in Wound depth from Baseline to Week 3 measure: Percentage Area of Wound Bed Covered with Granulation Tissue measure: Peri-wound Pain Scores at Dressing Removal sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lawson Health Research Institute city: London state: Ontario zip: N6C 2R5 country: Canada name: Teresa Novic role: CONTACT email: teresa.novick@lhsc.on.ca name: Adam Power role: PRINCIPAL_INVESTIGATOR lat: 42.98339 lon: -81.23304 hasResults: False

 nctId: NCT06306703 id: PhD Thesis of Duygu Sultan Oge briefTitle: Comparison of Teaching Methods of Pelvic Floor Muscle Contraction in Women overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-06-15 date: 2024-08-30 date: 2024-03-12 date: 2024-03-12 name: Duygu Sultan Oge class: OTHER briefSummary: The aim of our study; To evaluate the effectiveness of different teaching methods on correct pelvic floor muscle contraction in women who have not received pelvic floor muscle training (PFMT) before. Women who come to the gynecology and obstetrics clinic for examination and volunteer for the study will be randomized with a computer-aided randomization program and divided into 3 groups. First of all, the pelvic floor muscles will be evaluated by ultrasonographic method and perineometer. The first group will be taught pelvic floor muscle contraction with verbal explanation, the second group will be taught with digital vaginal palpation, and the third group will be taught pelvic floor muscle contraction with the help of a perineometer. After the training, the same evaluations will be made again. The number of individuals to be included in the study will be determined by power analysis. As a result of this study, it will be decided which method can be used to teach pelvic floor muscle contraction to women accurately and effectively in clinics. The results of our study will guide clinicians in their preferences for using different teaching methods. conditions: Pelvic Floor Muscle Weakness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: prospective randomized primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: healthcare provider performing USG evaluation person doing statistical analysis whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: group1, group2, group 3 measure: ASSESSMENT OF THE PELVIC FLOOR USING ULTRASONOGRAPHY (USG) measure: Pelvic Floor Muscle Strength and Endurance: measure: pelvic floor power, minimum and maximum muscle contraction values measure: DETAILED STORIES OF THE PATIENTS measure: Pelvic Floor Health Knowledge Test: measure: Global Pelvic Floor Disorder Questionnaire(GPFDQ) measure: Visual Analog Scale (VAS) assessment for pelvic pain measure: Determining the severity of incontinence measure: Sensory Evaluation measure: Pelvic Floor Reflex Evaluation: measure: Evaluation of Mistakes Made During Pelvic Floor Muscle Contraction measure: Pelvic organ prolapse evaluation sex: FEMALE minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06306690 id: 6401 briefTitle: Biomarkers in Retinitis Pigmentosa acronym: RPMARKER overallStatus: RECRUITING date: 2024-02-01 date: 2025-04 date: 2025-04 date: 2024-03-12 date: 2024-03-12 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The objective of this study is to discover biomarkers that demonstrate a correlation between the severity of retinitis pigmentosa (RP) and the thickness of the retinal pigment epithelium (RPE). These biomarkers will serve as prognostic indicators for various kinds of retinitis pigmentosa. The objective of this study is to find biomarkers that establish a correlation between the severity of retinitis pigmentosa and the thickness of the retinal pigment epithelium (RPE), which can serve as a prognostic indicator for Retinitis Pigmentosa. conditions: Retinitis Pigmentosa studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 35 type: ESTIMATED name: OCT, OCT angiography, flicker ERG and Ultra Wide Field retinography and autofluorescence. measure: Retinal pigment epithelium changes in Retinitis Pigmentosa. measure: Retinitis Pigmentosa biomarkers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maria Cristina Savastano status: RECRUITING city: Roma zip: 00198 country: Italy name: Maria C Savastano role: CONTACT phone: 3200609905 email: mariacristina.savastano@gmail.com lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06306677 id: SH9H-2023-T369-1 briefTitle: Accuracy of an AI-clinical Knowledge-based Hybrid System for Detecting Periodontitis in OPG Images overallStatus: RECRUITING date: 2024-03-12 date: 2024-08-01 date: 2024-12-31 date: 2024-03-12 date: 2024-03-13 name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University class: OTHER name: ShanghaiTech University name: University of Roma La Sapienza name: The University of Hong Kong briefSummary: Periodontitis is highly prevalent and rarely detected and treated in the earlier stages of the disease. Orthopantomography (OPG) is the most frequently taken dental radiograph around the world, and its systematic screening may contribute to early detection of periodontitis and access to the needed level of care. The investigators' recent study initially developed an AI-clinical knowledge-based system for automatic periodontitis diagnosis and indicated good performance for differentiating stage II-IV periodontitis. This cross-sectional diagnostic study aims to compare the diagnostic accuracy of this AI-clinical knowledge-based hybrid system (Index test) with human experts (reference test) for differentiating stage II-IV periodontitis using the OPG images obtained from different 4 centers around the world. conditions: Periodontitis conditions: Periodontal Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 1200 type: ESTIMATED name: AI-clincial-based hybrid system for radiographic image analysis measure: Sensitivity measure measure: Specificity measure measure: The area under the receiver operating characteristic curve (AUC) measure measure: Diagnostic accuracy measure: Assessment time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Perio-Implant Innovation Center status: RECRUITING city: Shanghai state: Shanghai zip: 201206 country: China name: Yuan Li role: CONTACT phone: 13916337473 email: ly9919@hotmail.com lat: 31.22222 lon: 121.45806 facility: Prince Philip Dental Hospital status: RECRUITING city: Hong Kong country: Hong Kong name: George Pelekos role: CONTACT email: george74@hku.hk lat: 22.27832 lon: 114.17469 facility: La Sapienza Dental School status: RECRUITING city: Roma country: Italy name: Lorenzo Marini role: CONTACT email: lorenzo.marini@uniroma1.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06306664 id: PT.REC/012/004881 briefTitle: Effect of Two Different Modes of Polarized Polychromatic Non-coherent Light Therapy on Jumper's Knee overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2025-11-29 date: 2025-12-01 date: 2024-03-12 date: 2024-03-12 name: Cairo University class: OTHER briefSummary: The purposes of this study are:

1. To examine the combined effects of Yellow CPPNLT and conventional treatment on pain intensity, pain pressure threshold, functional disability, and muscle strength in athletic jumper knee.
2. To examine the combined effects of Green CPPNLT and conventional treatment on pain intensity, pain pressure threshold, functional disability, and muscle strength in athletic jumper knee.

3 3- To compare between the effects of Yellow CPPNLT and Green CPPNLT on pain intensity, pain pressure threshold, functional disability, and muscle strength in athletic jumper knee. conditions: Jumper's Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: double whoMasked: PARTICIPANT count: 60 type: ACTUAL name: Bioptron name: Placebo Comparator measure: Pain (Visual analogue scale). measure: pain intensity (Pressure algometry) measure: Disability questionnaire (Victorian institute of sport assessment-patella). measure: Muscle strength (Hand held dynamometer) measure: Muscle strength and endurance ( Biodex-Isokinetic Dynamometer) sex: ALL minimumAge: 15 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Physical Therapy city: Giza state: Dokki zip: 12612 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06306651 id: FMASU MD283/2023 briefTitle: High Flow Nasal Cannula and Conventional Oxygen Therapy in the Postoperative Management of Patients With Mild to Moderate Obstructive Sleep Apnea overallStatus: RECRUITING date: 2024-03-16 date: 2025-03-01 date: 2025-03-01 date: 2024-03-12 date: 2024-03-19 name: Ain Shams University class: OTHER briefSummary: This study aims to compare the effectiveness of conventional oxygen therapy oxygen and high-flow nasal cannula therapy on oxygen saturation (SpO2), measuring number of SpO2 drop \>4% of base line oxygen saturation (o2 desaturation index), length of the ICU stay, and the need of use supplemental continuous positive airway pressure (CPAP) support in any of the study groups in the postoperative ICU setting. conditions: High Flow Nasal Cannula conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: High flow nasal cannula therapy group name: Conventional oxygen therapy group measure: Oxygen desaturation index measure: The length of Intensive care unit stay measure: The incidence of ventilatory support sex: ALL minimumAge: 21 Years maximumAge: 40 Years stdAges: ADULT facility: Ain Shams University status: RECRUITING city: Cairo zip: 11591 country: Egypt name: Omar M Mohamed, Master role: CONTACT phone: 00201063190923 email: omarmedhat0100565@med.asu.edu.eg name: Bahaa A Ali, MD role: SUB_INVESTIGATOR name: Adel M Alansary, MD role: SUB_INVESTIGATOR name: Nora M Mahmoud, MD role: SUB_INVESTIGATOR name: Mohamed M Abdallah, MD role: SUB_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06306638 id: I-3901323 id: NCI-2024-01239 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: I-3901323 type: OTHER domain: Roswell Park Cancer Institute briefTitle: Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2029-04-01 date: 2029-04-01 date: 2024-03-12 date: 2024-03-12 name: Roswell Park Cancer Institute class: OTHER briefSummary: This phase I/II trial studies the side effects of interstitial photodynamic therapy following palliative radiotherapy and how well it works in treating patients with inoperable malignant central airway obstruction. Patients who have advanced stage cancer tumors in the lung can often have the breathing passages to the lung partially or completely blocked. These tumors could be due to lung cancer or other cancers (e.g., renal, breast, kidney, etc.) that spread to the lung. This blockage puts the patient at a higher risk for respiratory failure, post-obstructive pneumonia, and prolonged hospitalizations. Treatment for these patients may include bronchoscopic intervention (such as mechanical removal, stenting, laser cauterization, or ballooning), radiation therapy with and without chemotherapy. While palliative x-ray radiotherapy may help in shrinking the tumor, high dose curative radiotherapy that can ablate (a localized, nonsurgical destruction) the tumor also has high risk to cause significant toxicity, including bleeding, abnormal connections or passageways between organs or vessels and abnormal scar tissue that can also produce airway obstruction. Photodynamic therapy (PDT) is another possible treatment that can provide local control of the tumor. PDT consists of injecting a light sensitive drug (photosensitizer, PS) into the vein, waiting for the PS to accumulate in the tumor, and then activating it with a red laser light. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving interstitial photodynamic therapy following palliative radiotherapy may improve tumor response and survival without the serious side effects that are associated with the typical high dose curative x-ray radiotherapy alone in patients with malignant central airway obstruction. conditions: Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 39 type: ESTIMATED name: Biospecimen Collection name: Computed Tomography name: Endobronchial Ultrasound Bronchoscopy name: Interstitial Photodynamic Therapy name: Palliative Radiation Therapy name: Physical Performance Testing name: Questionnaire Administration name: Verteporfin measure: Incidence of >= grade 3 adverse events (Phase I) measure: Overall tumor response (Phase II) measure: Overall tumor response (Phase I) measure: Quality of life (Phase I and II) measure: Functional lung capacity (Phase I and II) measure: Change in the therapeutic laser light transmission (Phase I and II) measure: Association between immune markers and tumor response (Phase I and II) measure: Progression free survival (Phase I and II) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Roswell Park Cancer Institute city: Buffalo state: New York zip: 14263 country: United States name: Nathaniel Ivanick role: CONTACT phone: 716-845-5873 email: Nathaniel.Ivanick@RoswellPark.org name: Nathaniel Ivanick role: PRINCIPAL_INVESTIGATOR lat: 42.88645 lon: -78.87837 hasResults: False

 nctId: NCT06306625 id: 69HCL21_0001 id: 2023-A01315-40 type: OTHER domain: ID-RCB briefTitle: REmote COnditioning in Out-of-Hospital Cardiac Arrest acronym: RECO-OHCA overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-04 date: 2026-08-15 date: 2024-03-12 date: 2024-03-13 name: Hospices Civils de Lyon class: OTHER briefSummary: Out-of-Hospital Cardiac Arrest remains a major public health problem, resulting in high mortality largely related to multiple organ failure and poor neurological outcomes due to brain anoxia. The pathophysiology of organ dysfunction after resuscitated out-of-hospital cardiac arrest involves ischemia-reperfusion processes. Remote ischemic conditioning is a therapeutic strategy used to protect organs against the detrimental effects of ischemia-reperfusion injury.

The objective of the present trial is to determine whether remote ischemic conditioning performed early after out-of-hospital cardiac arrest can decrease mortality, or multiple organ failure and/or severe neurological failure. conditions: Out-Of-Hospital Cardiac Arrest studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 220 type: ESTIMATED name: Remote ischemic conditioning name: No remote ischemic conditioning measure: All cause of death measure: Multiple organ failure measure: Severe neurological failure measure: Sepsis-related Organ Failure Assessment (SOFA) score measure: Sepsis-related Organ Failure Assessment (SOFA) score measure: Sepsis-related Organ Failure Assessment (SOFA) score measure: Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score measure: Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score measure: Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score measure: Sepsis-related Organ Failure Assessment (SOFA) sub-scores for each organ dysfunction measure: Sepsis-related Organ Failure Assessment (SOFA) sub-scores for each organ dysfunction measure: Sepsis-related Organ Failure Assessment (SOFA) sub-scores for each organ dysfunction measure: Mean Sepsis-related Organ Failure Assessment (SOFA) score measure: Mean Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score measure: Variations of the Sepsis-related Organ Failure Assessment (SOFA) score (delta-SOFA) measure: Variations of the Sepsis-related Organ Failure Assessment (SOFA) score (delta-SOFA) after exclusion of the neurological sub-score measure: Serum level of neuron-specific enolase (NSE) measure: Cerebral Performance Categories (CPC) scale measure: All-cause mortality sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Louis Pradel city: Bron zip: 69500 country: France name: Thomas BOCHATON role: CONTACT phone: 04 72 35 75 41 phoneExt: +33 email: thomas.bochaton@chu-lyon.fr name: Thomas BOCHATON role: PRINCIPAL_INVESTIGATOR lat: 45.73333 lon: 4.91667 facility: Hôpital Gabriel Montpied, CHU de Clermont Ferrand city: Clermont-Ferrand zip: 63000 country: France name: François THOUY role: CONTACT phone: 04 73 75 07 50 phoneExt: +33 email: fthouy@chu-clermontferrand.fr name: François THOUY role: PRINCIPAL_INVESTIGATOR lat: 45.77966 lon: 3.08628 facility: Centre Jean Perrin, Clermont-Ferrand city: Clermont-Ferrand zip: 69300 country: France name: Alexandre LAUTRETTE role: CONTACT phone: 04 73 27 80 80 phoneExt: +33 email: alautrette@chu-clermontferrand.fr name: Alexandre LAUTRETTE role: PRINCIPAL_INVESTIGATOR lat: 45.77966 lon: 3.08628 facility: Hôpital F Mitterrand, CHU de Dijon city: Dijon zip: 21079 country: France name: Jean-Pierre QUENOT role: CONTACT phone: 03 80 29 37 51 phoneExt: +33 email: jean-pierre.quenot@chu-dijon.fr name: Jean-Pierre QUENOT role: PRINCIPAL_INVESTIGATOR lat: 47.31667 lon: 5.01667 facility: Hôpital Albert Michallon, CHU de Grenoble city: La Tronche zip: 38700 country: France name: Carole SCHWEBEL role: CONTACT phone: 04 76 76 87 79 phoneExt: +33 email: cschwebel@chu-grenoble.fr name: Carole SCHWEBEL role: PRINCIPAL_INVESTIGATOR lat: 45.20429 lon: 5.73645 facility: Hôpital Edouard Herriot city: Lyon zip: 69003 country: France name: Marie-Line HARLAY role: CONTACT phone: 04 72 11 28 62 phoneExt: +33 email: marie-line.harlay@chu-lyon.fr name: Laurent ARGAUD role: CONTACT phone: 04 72 11 28 62 phoneExt: +33 email: laurent.argaud@chu-lyon.fr name: Marie-Line HARLAY role: PRINCIPAL_INVESTIGATOR name: Laurent ARGAUD role: SUB_INVESTIGATOR name: Martin COUR role: SUB_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Hôpital Saint-Joseph Saint-Luc city: Lyon zip: 69007 country: France name: Emmanuel VIVIER role: CONTACT phone: 04 78 61 82 09 phoneExt: +33 email: evivier@ch-stjosephstluc-lyon.fr name: Emmanuel VIVIER role: PRINCIPAL_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Hôpital de la Timone, CHU de Marseille city: Marseille zip: 13385 country: France name: Marc GAINNIER role: CONTACT phone: 04 91 38 85 50 phoneExt: +33 email: marc.gainnier@ap-hm.fr name: Marc GAINNIER role: PRINCIPAL_INVESTIGATOR lat: 43.29551 lon: 5.38958 facility: Hôpital lapeyronie, CHU de Montpellier city: Montpellier zip: 34295 country: France name: Kada KLOUCHE role: CONTACT phone: 04 67 33 77 36 phoneExt: +33 email: k-klouche@chu-montpellier.fr name: Kada KLOUCHE role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 facility: Hôpital Universitaire Carémeau city: Nîmes zip: 30029 country: France name: Claire ROGER role: CONTACT phone: 04 66 68 33 31 phoneExt: +33 email: claire.roger@chu-nimes.fr name: Claire ROGER role: PRINCIPAL_INVESTIGATOR lat: 43.83333 lon: 4.35 facility: Hôpital Lyon-Sud city: Pierre-Bénite zip: 69310 country: France name: Auguste DARGENT role: CONTACT phone: 04 78 86 21 18 phoneExt: +33 email: auguste.dargent@chu-lyon.fr name: Auguste DARGENT role: PRINCIPAL_INVESTIGATOR lat: 45.7009 lon: 4.82511 facility: Hôpital Nord, CHU de St Etienne city: Saint-Priest-en-Jarez zip: 42270 country: France name: Guillaume THIERY role: CONTACT phone: 04 77 12 78 62 phoneExt: +33 email: guillaume.thiery@chu-st-etienne.fr name: Guillaume THIERY role: PRINCIPAL_INVESTIGATOR lat: 45.47501 lon: 4.37614 facility: Hôpital Nord-Ouest city: Villefranche-sur-Saône zip: 69655 country: France name: Julien ILLINGER role: CONTACT phone: 04 74 09 29 31 phoneExt: +33 email: jillinger@hno.fr name: Julien ILLINGER role: PRINCIPAL_INVESTIGATOR lat: 45.98333 lon: 4.71667 hasResults: False

 nctId: NCT06306612 id: IIT-2023-0165 briefTitle: CytoREductive prostAtectomy for Poly-metastatic Hormone sensiTIVE Prostate Cancer acronym: CREATIVE overallStatus: RECRUITING date: 2024-03-21 date: 2028-12-31 date: 2028-12-31 date: 2024-03-12 date: 2024-04-10 name: RenJi Hospital class: OTHER briefSummary: The goal of this clinical trial is to compare systemic therapy combined with cytoreductive prostatectomy with standard of care (SOC) in de novo poly-metastatic hormone sensitive prostate cancer (de novo pmHSPC). The main questions it aims to answer are:

1. To explore the clinical benefit and safety of systemic therapy combined with cytoreductive prostatectomy for patients with de novo pmHSPC.
2. To explore the characteristics of the subgroup of patients who could benefit more from the above treatment.
3. To explore the relationship between stage efficacy and clinical prognosis.
4. To explore the correlation between molecular imaging such as PSMA-PET/CT and its changes with treatment efficacy.

Participants will undergo systemic therapy combined with cytoreductive prostatectomy.

Researchers will compare systemic therapy combined with cytoreductive prostatectomy with SOC to see the pros and cons of the two strategies. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 192 type: ESTIMATED name: Systemic Chemohormonal Therapy name: Systemic Hormonal Therapy name: Cytoreductive Prostatectomy name: Postoperative Adjuvant Radiotherapy measure: Castration resistant-free survival measure: Overall Survival measure: PSA response measure: Symptomatic skeletal event measure: Pain progression measure: Deterioration of disease-related somatic symptoms sex: MALE minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine status: RECRUITING city: Shanghai state: Shanghai zip: 200127 country: China name: Liang Dong, Dr. role: CONTACT phone: +86-13601613536 email: drdongliang@126.com name: Yinjie Zhu, Dr. role: PRINCIPAL_INVESTIGATOR name: Liang Dong, Dr. role: PRINCIPAL_INVESTIGATOR name: Ruohua Chen, Dr. role: SUB_INVESTIGATOR name: Xinxing Du, Dr. role: SUB_INVESTIGATOR name: Yanhao Dong, Dr. role: SUB_INVESTIGATOR name: Hanjing Zhu role: SUB_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06306599 id: Thyroid AI US operator exp briefTitle: Ultrasound Operator Influence on Diagnostics With AI for Thyroid Nodules - Clinial Trial overallStatus: COMPLETED date: 2023-09-01 date: 2023-11-04 date: 2023-11-04 date: 2024-03-12 date: 2024-03-12 name: Rigshospitalet, Denmark class: OTHER briefSummary: This is a prospective clinical study aiming to test how the experience of the ultrasound operator influences the performance of AI-based (artificial intelligence-based) diagnostics when analysing thyroid nodules on ultrasound scans. The investigators set up an experiment with five stations, each with a patient with a thyroid nodule and an ultrasound machine with the deep learning based system S-Detect for Thyroid installed. 20 study participants where recruited: 8 medical students of novice ultrasound skill, 3 junior ENT (ear-nose-throat) registrars of intermediate ultrasound skill, and 9 senior ENT registrars experienced in ultrasound. The participants scanned all the patients and recorded their analyses of the nodules using the EUTIRADS (European thyroid imagining reporting and data system) system in three different ways: a analysis of their own, S-Detect's analysis, and an analysis combining the two previous.

The hypothesis was that the AI system would perform equally well when between the participant groups. In addition, it was expected that the experienced participants would perform better than the students without AI help, and that the doctors would gain little from AI input, but that the students would have their performance improved by AI input. conditions: Thyroid Nodule studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 20 participants scan five patients over the course of fours hour and collect their diagnostics analyses on paper forms. primaryPurpose: DIAGNOSTIC masking: NONE count: 20 type: ACTUAL name: S-Detect for Thyroid measure: Accuracy of S-Detect diagnosis measure: Accuracy of biopsy recommendation measure: Nodule classification agreement measure: Accuracy of EUTIRADS scores measure: Nodule measurement measure: OSAUS score sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet city: Copenhagen zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06306586 id: 639031 briefTitle: A Digital Treatment for Adolescents With Eating Disorders overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2026-01-01 date: 2026-01-01 date: 2024-03-12 date: 2024-04-03 name: Haukeland University Hospital class: OTHER name: Helse Fonna briefSummary: The goal of this feasibility study is to evaluate the feasibility and preliminary clinical outcomes of a personalized digital treatment for adolescents with eating disorders. The main objectives are to:

i) Evaluate whether a personalized digital treatment for adolescents with eating disorders are feasible in a child and adolescent psychiatric outpatient clinic.

ii) Evaluate who benefits from a personalized digital treatment for adolescents with eating disorders (what works for whom?) iii) Evaluate the cost-benefit of a personalized digital treatment for adolescents with eating disorders.

Participants will be enrolled in a 10-week digital treatment including weekly therapist contact. They will be asked to complete self-report questionnaires at pre-, during, post- and 3- and 6-months follow-up. conditions: Eating Disorders studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Digital Treatment for Adolescents With Eating Disorders measure: The Credibility and Expectancy Scale (CEQ-1) measure: Adherence measure: Module evaluations measure: Client Satisfaction Questionnaire (CSQ-3) measure: Recruitment measure: Eating disorder symptoms measure: The Clinical Impairment Assessment Questionnaire (CIA) measure: The KIDSCREEN (KIDSCREEN-10) measure: The Patient Health Questionnaire (PHQ-2) measure: Generalized Anxiety Disorder scale (GAD-2) measure: School attendance measure: Tme with friends measure: Difficulties with Emotion Regulation Scale (DERS-18) measure: EuroQoL 5D-5L (EQ-5D-5L) measure: The Rosenberg Self-Esteem Scale (RSES) measure: The readiness to change questionnaire (RTCQ-6) measure: Qualitative interviews sex: ALL minimumAge: 16 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06306573 id: CL1019613 briefTitle: CardioMEMS HF System Real-World Evidence Post-Approval Study overallStatus: ENROLLING_BY_INVITATION date: 2022-12-15 date: 2027-12-31 date: 2028-12-31 date: 2024-03-12 date: 2024-03-12 name: Abbott Medical Devices class: INDUSTRY briefSummary: The purpose of this post-approval study (PAS) is to evaluate the long-term safety and effectiveness of the CardioMEMS™ HF System using real-world evidence (RWE) methods. conditions: Heart Failure NYHA Class II conditions: Heart Failure NYHA Class III studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2500 type: ESTIMATED name: CardioMEMS HF System measure: Two-Year Survival in the Primary Cohort (NYHA Class II subjects) measure: Two-Year Survival in the Full Cohort (NYHA Class II and Class III subjects) measure: 3-Year Survival measure: HF Hospitalization Rate measure: Pulmonary Artery (PA) Pressures Measured by the CardioMEMS PA Sensor measure: Subject Compliance Rates with Weekly Pulmonary Artery (PA) Pressure Uploads measure: Number of Subjects with Heart Failure (HF) Prescription Medication Fills measure: Proportion of Subjects with Heart Failure (HF) Prescription Medication Fills sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Abbott Medical city: Atlanta state: Georgia zip: 30313 country: United States lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06306560 id: MA-SCLC-II-018 briefTitle: A Study of Adebrelimab Combined With Famitinib and Chemotherapy in the Treatment of ES-SCLC. overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2027-03-15 date: 2027-04-15 date: 2024-03-12 date: 2024-03-12 name: Harbin Medical University class: OTHER briefSummary: This is a single arm, multi-center, phase II trial to evaluate the efficacy, and safety of adebrelimab combined with famitinib and chemotherapy for the treatment of first-line extensive stage small cell lung cancer. conditions: Extensive-stage Small-cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: adebrelimab name: famitinib name: chemotherapy measure: 6-month progression-free survival measure: 12-month progression-free survival measure: Objective Response Rate measure: Disease control rate measure: Overall Survival measure: AEs measure: QoL measure: Progression-Free-Survival sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06306547 id: IIM001 briefTitle: Clinical Study Cohort of Idiopathic Inflammatory Myositis overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2034-04-01 date: 2034-04-01 date: 2024-03-12 date: 2024-03-12 name: RenJi Hospital class: OTHER briefSummary: Idiopathic inflammatory myositis (IIM), also known as myositis, are a heterogeneous group of diseases characterized by chronic inflammation of striated muscles and skin, with different clinical manifestations, treatment responses, and prognosis. This project will build a clinical follow-up cohort for idiopathic inflammatory myositis (IIM) centered on Renji Hospital, Shanghai Jiao Tong University School of Medicine, to promote the clinical and pathogenesis of this group of diseases. conditions: Idiopathic Inflammatory Myopathies studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1000 type: ESTIMATED name: no interventions were involved measure: High Resolution Computed Tomography of Chest measure: Cutaneous Disease Area and Severity Index measure: Forced vital capacity measure: Manual Muscle Testing measure: Forced expiratory volume in one second measure: Serum creatine kinase sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06306534 id: AIS-001 id: CIV-22-05-039592 type: OTHER_GRANT domain: Blackrock Neurotech briefTitle: Auditory Intranerve Stimulation Study acronym: AIS overallStatus: RECRUITING date: 2023-05-15 date: 2024-10-15 date: 2024-11-15 date: 2024-03-12 date: 2024-03-12 name: Hannover Medical School class: OTHER briefSummary: This feasibility clinical investigation is designed to answer the question of whether auditory brainstem responses can be safely elicited by acute electrical stimulation within the human auditory nerve. conditions: Auditory; Nerve studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ESTIMATED name: Auditory Nerve Acute (ANA) Electrode Array measure: Elicit a typical eABR Wave V with at least 0.2 µV in amplitude and a latency of the peak around 5 ms measure: Collection of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hannover Medical School status: RECRUITING city: Hannover zip: 30625 country: Germany name: Karl-Heinz Dyballa role: CONTACT email: dyballa.karl-heinz@mh-hannover.de lat: 52.37052 lon: 9.73322 hasResults: False

 nctId: NCT06306521 id: 20235517 briefTitle: An Adaptive Clinical Trial of BeginNGS Newborn Screening for Hundreds of Genetic Diseases by Genome Sequencing acronym: BeginNGS overallStatus: RECRUITING date: 2024-02-29 date: 2029-02 date: 2029-02 date: 2024-03-12 date: 2024-03-12 name: Rady Pediatric Genomics & Systems Medicine Institute class: OTHER briefSummary: The goal of this clinical trial is to test a new method for newborn screening using whole genome sequencing, called BeginNGS. Parents will be approached to provide informed consent to enroll their newborns in prenatal, postnatal, and outpatient settings. The main questions this study aims to answer are:

What is the utility of BeginNGS as compared to state newborn screening? What is the acceptability and feasibility of BeginNGS as compared to state newborn screening? What is the cost effectiveness of BeginNGS as compared to state newborn screening?

Enrolled newborns will have a blood sample taken and will receive the BeginNGS test. Newborns will have also had the state newborn screening test. conditions: Genetic Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 10000 type: ESTIMATED name: BeginNGS Test measure: Comparison of the clinical utility of BeginNGS and standard of care (state NBS), defined by the proportion of enrollees likely to benefit (likely to have an improved outcome) from an indicated therapeutic intervention measure: Utility secondary outcome 1 measure: Utility secondary outcome 2 measure: Utility secondary outcome 3 measure: Utility secondary outcome 4 measure: Utility secondary outcome 5 measure: Utility secondary outcome 6 measure: Utility secondary outcome 7 measure: Utility secondary outcome 8 measure: Utility secondary outcome 9 measure: Utility secondary outcome 10 measure: Acceptability outcome 1 measure: Acceptability outcome 2 measure: Acceptability outcome 3 measure: Acceptability outcome 4 measure: Feasibility (ability of the study to be undertaken as designed) outcome 1 measure: Feasibility (ability of the study to be undertaken as designed) outcome 2 measure: Feasibility (ability of the study to be undertaken as designed) outcome 3 measure: Feasibility (ability of the study to be undertaken as designed) outcome 4 measure: Feasibility (ability of the study to be undertaken as designed) outcome 5 measure: Cost effectiveness outcome 1 measure: Cost effectiveness outcome 2 measure: Cost effectiveness outcome 3 measure: Cost effectiveness outcome 4 measure: Accuracy outcome 1 measure: Accuracy outcome 2 measure: Utility secondary outcome 11 measure: Feasibility outcome 6 measure: Feasibility outcome 7 measure: Utility secondary outcome 12 sex: ALL minimumAge: 1 Day maximumAge: 28 Days stdAges: CHILD facility: Rady Children's Hospital San Diego status: RECRUITING city: San Diego state: California zip: 92123 country: United States name: Lauren Olsen, MSN role: CONTACT phone: 858-576-1700 phoneExt: 228456 email: lolsen1@rchsd.org lat: 32.71533 lon: -117.15726 hasResults: False

 nctId: NCT06306508 id: HUvbayraktaroglu briefTitle: Effect of Parental Attitude on Functional and Physical Level of Children With Cystic Fibrosis overallStatus: RECRUITING date: 2024-02-16 date: 2025-02-16 date: 2025-02-16 date: 2024-03-12 date: 2024-03-12 name: Halic University class: OTHER briefSummary: Some parents may be more protective of children with CF due to concerns about worsening of the disease due to infection, which can affect their functional level. The goal of this observational study is to learn about the family's protective approach to the functioning and disease course of children with cystic fibrosis (CF) to determine whether there are possible negative effects. There will be an alternative viewpoint offered to clinicians regarding the management of CF with outputs of this study. conditions: Cystic Fibrosis conditions: Cystic Fibrosis in Children studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED measure: Modified shuttle walk test (MST) measure: Forced expiratory volume at one second (FEV1) measure: Forced vital capacity (FVC) measure: Forced expiratory volume at one second / Forced vital capacity rate (FEV1/FVC) measure: Peak expiratory flow (PEF) measure: Maximum inspiratory pressure (MIP) measure: Maximum expiratory pressure (MEP) measure: Physical Activity Questionnaire for Children (PAQ-C) measure: Munich physical fitness test (MFT) measure: Quadriceps strength measure: Handgrip strength measure: Cystic Fibrosis Questionnaire Revised (CFQ-R) measure: Parental Attitude Scale (PAS) measure: Parent Attitude Scale measure: Perceived Social Support Scale (PSS) measure: Breathlessness Beliefs Questionnaire (BBQ) sex: ALL minimumAge: 7 Years maximumAge: 17 Years stdAges: CHILD facility: Haliç University status: RECRUITING city: Istanbul state: Eyup zip: 34060 country: Turkey name: Vildan Bayraktaroglu, PT, MSc role: CONTACT phone: (0212) 924 24 44 email: vildanbayraktaroglu@halic.edu.tr name: Seda Saka, PT, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06306495 id: 26.01.2022/17 briefTitle: Insomnia, Physical Activity Level and Stress Level acronym: PA overallStatus: COMPLETED date: 2022-03-27 date: 2023-08-12 date: 2024-01-29 date: 2024-03-12 date: 2024-03-12 name: Halic University class: OTHER briefSummary: Insomnia is a common, acute, intermittent, or chronic complaint of unwanted sleep difficulties characterized by sleep disturbance. Important risk factors leading to insomnia: advanced age, poor health, work stress, shift work, loss of a loved one, divorce, domestic violence, excessive anxiety, repressed personality, perfectionism, neuroticism, alcohol and substance abuse, excessive caffeine intake, excessive smoking, low socio-economic status and low physical activity level. Research shows that college students face more sleep problems than the general public. Factors that disrupt the sleep hygiene of university students; Students' excessive use of computers during lecture and exam periods, exposure to lights and screens for long periods of time, and environmental changes. The aim of this study is to determine the prevalence of insomnia in healthy individuals after the start of face-to-face education in university students after the pandemic period and to determine the physical activity associated with insomnia in this population group. Examining levels and other behavioral factors. The research was conducted on students studying at Istanbul Rumeli University, Haliç University and Yalova University between March 2022 and August 2022. It will be held online via Google Forms with students between the ages of 18-25. Study data will be collected with the International Physical Activity Survey, Demographic Data Form, Sleep Hygiene Index, Distress Tolerance Scale, and Pittsburgh Sleep Quality Index. An application will be made to obtain approval from the Haliç University Non-Interventional Clinical Research Ethics Committee. Informed consent will be obtained from people participating in the research. Statistical analysis of the data will be done with IBM SPSS 23.0 software. conditions: Sleep Initiation and Maintenance Disorders studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 473 type: ACTUAL name: International Physical Activity Survey measure: Prevalence of insomnia in university students measure: The effect of insomnia on physical activity level measure: The effect of insomnia on stress levels in university students measure: Effects of sleep hygiene on insomnia in university students sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Halic University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06306482 id: SBA 23/390 briefTitle: Determination of Posture in Patients With Restrictive and Obstructive Lung Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-07 date: 2025-03-07 date: 2026-03-07 date: 2024-03-12 date: 2024-03-12 name: Hacettepe University class: OTHER briefSummary: The aim of this study is to determine posture and posture related factors in patients with restrictive and obstructive lung disease. conditions: Lung Diseases, Obstructive conditions: Lung Diseases conditions: Postural; Defect studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 90 type: ESTIMATED measure: Evaluation of horizontal alignment of the head anterior view measure: Evaluation of horizontal alignment of the trunk anterior view measure: Evaluation of horizontal alignment of the head lateral view measure: Evaluation of vertical alignment of the head lateral view measure: Evaluation of horizontal alignment of the trunk lateral view measure: Evaluation of vertical alignment of the trunk lateral view measure: Evaluation of horizontal asymmetry trunk in posterior view measure: Evaluation of scapulae measure: Posture measure: Functional exercise capacity measure: Respiratory Muscle Strength measure: Lung function measure: Dyspnea measure: Peripheral muscle strength measure: Lower extremity capacity measure: Energy expenditure measure: Balance and Fall risk measure: Tightness of muscle measure: Severity of disease for patients with COPD measure: Severity of disease for patients with bronchiectasis measure: Diffusion capacity for patients with diffuse parenchymal lung diseases measure: Symptoms for patients with COPD sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aynur Demirel city: Ankara zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 facility: Hacettepe University city: Ankara zip: 06100 country: Turkey name: Aynur Demirel role: CONTACT phone: +905545295057 phoneExt: 178 email: aynur.demirel@hacettepe.edu.tr name: hidaye yamikan role: CONTACT phone: +905349898724 email: hidaye.yamikan@hacettepe.edu.tr name: hidaye yamikan role: SUB_INVESTIGATOR name: irem seleoglu role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06306469 id: PHRI-2022-1001 briefTitle: Changes in Microbiota in Healthy Subjects Before and After Meditation Practices in a Controlled Environment overallStatus: COMPLETED date: 2022-07-02 date: 2022-07-09 date: 2024-01-11 date: 2024-03-12 date: 2024-03-12 name: Pranic Healing Research Institute class: OTHER briefSummary: The goal of the study is to evaluate the Changes in Microbiota Markers in Healthy Subjects Before, During and After Meditation Practices in a Controlled Environment.

This study provides a unique opportunity to test the hypotheses that (1) Arhatic Yoga practices will affect both oral and gut microbiome; (2) the oral and gut microbiome will shift dynamically in a short period; and (3) the overall shift resulting from the changes in the gut microbiome members will be associated with known benefits to health and well-being. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 27 type: ACTUAL name: Meditation practice measure: Assessing the changes in gut and oral microbiome profile of the participants during retreat sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pranic Healing Research Institute city: Lyndhurst state: New Jersey zip: 07071 country: United States lat: 40.81204 lon: -74.12431 hasResults: False

 nctId: NCT06306456 id: GH21C201 briefTitle: A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC overallStatus: RECRUITING date: 2024-02-06 date: 2025-12-31 date: 2026-12-31 date: 2024-03-12 date: 2024-03-12 name: Suzhou Genhouse Bio Co., Ltd. class: OTHER briefSummary: This study, including phase Ib , phase IIa and phase IIb, aims to evaluate the safety, tolerability, PK profile, efficacy and to determine the RP2D of GH21 capsules combined with Osimertinib mesylate tablets in NSCLC patients with EGFR mutations. conditions: Non-Small Cell Lung Cancer With EGFR Mutation studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 94 type: ESTIMATED name: GH21+Osimertinib measure: Number of participants with dose limiting toxicities measure: Number of participants with adverse events measure: Progression-free survival (PFS) measure: Objective response rate (ORR) measure: Duration of response (DOR) measure: Duration of response (DCR) measure: Overall survival (OS) measure: Progression-free survival (PFS) measure: Number of participants with adverse events measure: Plasma concentration (Cmax) measure: Time to achieve Cmax (Tmax) measure: Area under the plasma concentration-time curve (AUC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Pulmonary Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200433 country: China name: Caicun Zhou, Doctorate role: CONTACT phone: 021-65115006 email: caicunzhoudr@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06306443 id: 20235453 briefTitle: Buprenorphine for Individuals in Jail overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-12-31 date: 2028-12-31 date: 2024-03-12 date: 2024-03-12 name: Friends Research Institute, Inc. class: OTHER briefSummary: This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (SL-B) in a large metropolitan jail. An open-label design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to either XR-B (n=120) or SL-B (n=120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and a final long-term follow-up at 12-months. conditions: Opioid Use Disorder studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: open label randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 240 type: ESTIMATED name: extended-release buprenorphine (XR-B) measure: urine toxicology measure: days of opioid use measure: time to opioid relapse measure: retention in buprenorphine treatment measure: urine toxicology for other illicit substance use measure: days of illicit substance use measure: overdose events measure: PROMIS Patient-Reported Outcomes Measurement Information System - physical health measure: PROMIS Patient-Reported Outcomes Measurement Information System - mental health measure: HIV risk behaviors (Risk Assessment Battery, RAB) - sex risk score measure: HIV risk behaviors (Risk Assessment Battery, RAB) needle use or sharing score measure: criminal activity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Friends Research Institute city: Baltimore state: Maryland zip: 21201 country: United States lat: 39.29038 lon: -76.61219 facility: Baltimore Central Booking & Intake Center city: Baltimore state: Maryland zip: 21202 country: United States name: Michael Gordon, DPA role: CONTACT phone: 410-837-3977 phoneExt: 251 email: mgordon@friendsresearch.org name: Thomas R Blue, PhD role: CONTACT phone: 4108373977 email: tblue@friendsresearch.org lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06306430 id: uLAM TB FIA briefTitle: Detection of Lipoarabinomannan in Urine Evaluation of the STANDARDTMF TBLAMFIA and Its Impact on the Initial TB Diagnosis acronym: uLAMTBFIA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2025-10 date: 2024-03-12 date: 2024-03-12 name: Ospedale San Raffaele class: OTHER briefSummary: Evaluation of the performance of an in vitro test, the STANDARDTM F TB LAM Ag FIA (SD BIOSENSOR, INC.) for the early diagnosis of tuberculosis (TB) infection. This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of tuberculosis infection. The test will be used according to the instructions for use (IFU). conditions: Tuberculosis conditions: Diagnoses Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 550 type: ESTIMATED name: STANDARDTM F TB LAM FIA measure: Evaluate the diagnostic performance of a new test based on the detection of lipoarabinomannan (LAM) antigen in human urine using immunoassay measure: Exploratory Objectives Evaluate if the test can be used as marker of treatment response (only for PTB subjects) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emerging Bacterial Pathogens Unit city: Milan zip: 20132 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06306417 id: PKUTH TCM briefTitle: A Randomized Controlled Trial of Acupuncture for Insulin Resistance in Patients With Polycystic Ovary Syndrome overallStatus: RECRUITING date: 2023-09-28 date: 2025-04-30 date: 2025-08-30 date: 2024-03-12 date: 2024-03-12 name: Peking University Third Hospital class: OTHER briefSummary: To determine the efficacy and safety of 2 different treatment modalities: 1) acupuncture plus lifestyle management (treatment group), 2) placebo plus lifestyle management (control group) in the treatment of insulin resistance in PCOS patients. conditions: Polycystic Ovary Syndrome (PCOS) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 144 type: ESTIMATED name: lifestyle intervention name: acupuncture name: Sham acupuncture measure: HOMA-IR measure: Hirsutism(FG score >4）, acne and early alopecia measure: AUC insulin measure: Follicle stimulating hormone (FSH) measure: luteinizing hormone (LH) measure: Progestin (P) measure: Estrogen (E2) measure: Prolactin (PRL) measure: Androgen(T) measure: Anti-mullerian hormone (AMH) measure: Sex hormone-binding globulin (SHBG) measure: Free testosterone index (FAI) measure: total cholesterol measure: triglycerides measure: high density lipoprotein (HDL) measure: low density lipoprotein (LDL) measure: Bile acidomics measure: Metagenomics and 16S rDNA sequencing analysis measure: short form-36 (SF36) measure: Self-Rating Anxiety Scale (SAS) measure: Self-Rating Depress Scale (SDS) measure: polycystic ovary syndrome questionnaire, PCOSQ measure: BMI measure: Fat% measure: waist to hip ratio(WHR) measure: glycosylated hemoglobin level measure: ovarian size measure: number of follicles measure: uterine size measure: endometrial thickness sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Peking University third hospital status: RECRUITING city: Beijing country: China name: Haolin Zhang, PHD role: CONTACT phone: +8615611963539 email: zoe@bjmu.edu.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06306404 id: NL86165.100.24 briefTitle: Improving Sleep and Mood in the Peri-menopause overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2028-06-01 date: 2028-06-01 date: 2024-03-12 date: 2024-03-12 name: VU University of Amsterdam class: OTHER name: ZonMw: The Netherlands Organisation for Health Research and Development name: Netherlands Brain Foundation name: Purplexus briefSummary: The perimenopause is known as a vulnerable period for some women, with noticeable somatic and psychological issues. Aside from climacteric symptoms, insomnia and depression are common. About half of women during the peri-menopausal period experience sleep problems like problems falling asleep, awakening during the night and being unable to return to sleep. This is often attributed to vasomotor symptoms, but this is not the only reason of poor sleep (Joffe et al., 2010). Also, the peri-menopausal period is a critical time for the occurrence of new onset and recurrent depressions (Cohen et al., 2006). It has been suggested that fluctuations in estradiol may increase the risk for depression by altering neuronal functions in the brain. But there are also indications that the risk for depression increases by indirect effects, such as the increase in insomnia. Poor sleep has increasingly been recognized as the key modifiable factor affecting mental issues like depression (Van Someren, 2021). While antidepressants and psychotherapies continue to be the treatments of choice for depression, and Cognitive Behavioral Therapy for sleep (CBTi) for insomnia, preclinical and clinical data support the benefits of estrogen-based therapies to improve mood, sleep and other menopause-related symptoms (Gordon et al. 2018). Transdermal estradiol patches, which provide a stable release of estradiol and lead to more stable blood levels, have been suggested to have a positive effect on sleep (Joffe et al., 2020) and depressive symptoms (Gordon et al., 2018) in randomized controlled trials. However, it is currently unclear if the relation between improvement in mood and estradiol patches is mediated by improvement in sleep problems, and if the effect of estradiol patches on sleep problems is more effective during peri-menopause than the current evidence-based sleep interventions of CBTi, preferably in combination with Circadian Rhythm Support (CRS). The aim of the study is to pinpoint the determinants of complaints about sleep and mood and how they respond to Menopausal Hormone Treatment (MHT) with and without the addition of a guided eHealth sleep intervention that combines CBTi + CRS.

Measurements will be conducted at baseline (T0), 2 months (T1) and 4 months (T3), with questionnaires, sleep measurements (EEG sleepband and actigraph) and skin conductance (to measure hot flushes). Participants will be recruited via www.slaapregister.nl and via OLVG outpatient clinic population of peri-menopausal women seeking help for climacteric complaints (like hot flushes, feeling bloated, increase in weight), including sleep problems. The participants are adults between 40-55 years old, with an Insomnia Severity Index score ≥10 and Climacteric Green Scale score ≥ 13.They have the self-considered capability to complete online questionnaires and diaries in Dutch.

The intervention will be MHT (estradiol transdermal patches 50 mcg (Systen), in combination with 200 mg progesterone (Utrogestan tablets for 2 weeks, adjusted to the menstrual cycle to prevent endometrium carcinoma according to the international MHT guidelines), with and without the addition of a guided eHealth sleep intervention that combines CBTi + CRS. conditions: Menopause conditions: Insomnia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 222 type: ESTIMATED name: Estrogens and Progestogens name: Cognitive behavioral therapy for insomnia (CBTi), and circadian rhythm therapy measure: The primary outcome variable is the difference between the groups in the within-subject change in insomnia severity at T1 (2 months) and T2 (4 months) relative to T0 (baseline). sex: FEMALE minimumAge: 40 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06306391 id: IMIMFCTL/NLX_1 briefTitle: Pharmacokinetics of Intravenous and Intranasal Formulations of Naloxone in Healthy Volunteers. overallStatus: RECRUITING date: 2024-03-05 date: 2024-09 date: 2024-09 date: 2024-03-12 date: 2024-03-15 name: Parc de Salut Mar class: OTHER name: Food and Drug Administration (FDA) briefSummary: This is a phase I interventional clinical trial and the aim will be to characterize the PK and PD of two formulations of naloxone (intranasal and intravenous) in healthy subjects, which will be used to verify/validate nasal-CNS-PBPK (Physiologically Based Pharmacokinetic) model predictions following intranasal dosing. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: Intravenous naloxone name: Intranasal naloxone measure: Effects of naloxone on heart rate (HR). measure: Effects of naloxone on systolic and diastolic blood pressure (BP). measure: Effects of naloxone on plasma cortisol at visit 1 and visit 4. measure: Adverse effects. sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: IMIM (Hospital del Mar Medical Research Institute) status: RECRUITING city: Barcelona zip: 08003 country: Spain name: Rafael De la Torre Fornell, PharmD, PhD role: CONTACT phone: 00343160780 phoneExt: 1780 email: rtorre@imim.es lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06306378 id: XJTU1AF2023LSK-481 briefTitle: The Relationship Between Social Memory Disorders and Sleep Spindles in Children With Autism Spectrum Disorder overallStatus: RECRUITING date: 2023-12-04 date: 2024-03-30 date: 2024-04-30 date: 2024-03-12 date: 2024-03-12 name: First Affiliated Hospital Xi'an Jiaotong University class: OTHER name: Xi'an TCM Hospital of Encephalopathy briefSummary: Research background and project basis

Autism spectrum disorder (ASD) is a lifelong neurodevelopmental disorder characterized by social disorders and repetitive stereotypical behavior. Social memory impairment is a significant feature of ASD patients, and the specific pathogenesis of social memory impairment in ASD patients is currently unclear, and there are no objective indicators to measure social memory levels. Sleep spindle wave is a special brain wave in sleep that is closely related to memory consolidation. However, no one has yet studied the impact of sleep spindles on social memory.

Research purpose

Exploring the correlation between sleep spindles and social memory in the population, providing reference for the auxiliary diagnosis of social memory disorders in children with ASD. conditions: Autism Spectrum Disorder studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 60 type: ESTIMATED name: social memory levels and spindle levels measure: Recognition accuracy measure: Response delay time measure: Sleep spindle density measure: Sleep spindle average duration measure: Sleep spindle amplitude measure: Sleep spindle frequency sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: First Afflicated Hospital Xian Jiaotong University status: RECRUITING city: Xi'an state: Shaanxi zip: 710061 country: China name: Yan Li, MD., PhD. role: CONTACT phone: 13720418610 email: liyanxjtu@xjtu.edu.cn name: Dongqi Cui, PhD. role: CONTACT phone: 18501059233 email: 18501059233@163.com lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06306365 id: PI-DOC003-WBOA briefTitle: Effects of Modern Board Games on Well Being in Older Adults acronym: JUMEMO3e+ overallStatus: RECRUITING date: 2024-02-07 date: 2024-06-28 date: 2024-06-28 date: 2024-03-12 date: 2024-03-12 name: European University Miguel de Cervantes class: OTHER name: Centro Doctor Villacián, Valladolid, Spain briefSummary: The aim of the study is to assess the effects of an intervention using modern board game-based learning in a sample of older individuals. The evaluation will focus on determining if there is a change in executive functions, social participation, and participants' perception of well-being. conditions: Executive Functions studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A quasi-experimental methodology will be employed, involving both a control group and an experimental group. Randomized control trial. primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: No masking. count: 35 type: ESTIMATED name: Modern board game-based learning measure: Examination for Mental Disorders of the Elderly measure: Trail Making Test to evaluate Executive Functions measure: Assessment of quality of life in older adults and people with disabilities measure: Psychometric development and practical use sex: ALL minimumAge: 65 Years maximumAge: 120 Years stdAges: OLDER_ADULT facility: European University Miguel of Cervante status: RECRUITING city: Valladolid zip: 47012 country: Spain name: Azael J. Herrero, PhD role: CONTACT phone: +34983001000 email: jaherrero@uemc.es name: Raquel Martínez-Sinovas, PhD role: CONTACT phone: +34983001000 email: rmsinovas@uemc.es lat: 41.65518 lon: -4.72372 hasResults: False

 nctId: NCT06306352 id: 1070 id: NL82999.091.22 type: OTHER domain: CCMO briefTitle: Vibrotactile Feedback in Exoskeletons overallStatus: COMPLETED date: 2023-03-06 date: 2023-06-21 date: 2023-06-21 date: 2024-03-12 date: 2024-03-12 name: Sint Maartenskliniek class: OTHER name: ABLE Human Motion S.L. name: Netherlands Organisation for Scientific Research briefSummary: This study aims to investigate the impact of providing discrete vibrotactile feedback related to weight shift and step initiation on exoskeleton use in individuals with motor-complete SCI. conditions: Spinal Cord Injuries studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 7 type: ACTUAL name: Vibrotactile feedback measure: Walking distance covered measure: Reach path ratio measure: Reach time measure: User experience questionnaire measure: Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology (D-QUEST) - only including the eight items related to user satisfaction with the assistive device measure: Dutch System Usability Scale (D-SUS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sint Maartenskliniek city: Nijmegen country: Netherlands lat: 51.8425 lon: 5.85278 hasResults: False

 nctId: NCT06306339 id: hzVSF_v13-0015 briefTitle: A Study to Assess the Efficacy and Safety of Burfiralimab (hzVSF-v13) and DMRD (Disease-modifying Antirheumatic Drug) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-05 date: 2025-07 date: 2024-03-12 date: 2024-03-12 name: ImmuneMed, Inc. class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the efficacy and safety of intravenous infusions of burfiralimab (hzVSF-v13) when added to Disease-Modifying Antirheumatic Drug (DMARD) treatment as Standard of Care (SOC) in participants with moderate to severe Rheumatoid Arthritis (RA). conditions: Moderate to Severe Rheumatoid Arthritis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Burfiralimab name: SOC (Standard of care) name: Placebo measure: Proportion of participants achieving clinical response according to the ACR 20 criteria at Week 12 measure: Clinical response at Week 12, assessed as the attainment of an LDA (Low Disease Activity) state defined measure: Clinical response at Week 12, assessed as remission defined measure: Improvement of physical function at Week 12 measure: Pain relief at Week 12 assessed by the (mean) change from Baseline measure: Health-related quality of life at Week 12, assessed as the change from Baseline sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Urtrecht city: Utrecht state: GA country: Netherlands lat: 52.09083 lon: 5.12222 hasResults: False

 nctId: NCT06306326 id: pkussfatgrafting briefTitle: 3D Facial Scanning for Evaluating Autologous Fat Grafting in Craniofacial Deformities overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2028-12-01 date: 2029-03-01 date: 2024-03-12 date: 2024-04-18 name: Peking University class: OTHER briefSummary: Treatment of craniofacial deformities is a significant topic in oral and maxillofacial surgery, and autologous fat grafting has become one of the main methods for treating facial concave deformities. However, the instability of its treatment effect has always been a bottleneck in this field, mainly due to the uncertain absorption rate of transplanted fat. This project aims to use advanced the 3dMD face system (3dMD) (3dMD Inc, Atlanta, Ga) technology to precisely measure the facial volume changes before and after autologous fat grafting to address this issue. By performing autologous fat grafting surgery on 100 patients with craniofacial deformities that meet the research criteria, 3dMD technology will be used for facial three-dimensional scanning preoperatively, immediately postoperatively, and at six months postoperatively to obtain facial volume data. Then, through precise data analysis, we will calculate the fat absorption rate and study the effects of individual factors on treatment outcomes through correlation regression analysis. conditions: Adipocytes conditions: Autografts conditions: Imaging, Three-Dimensional / Methods studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: 3dMD technology measure: Fat Retention Rate measure: Patient Satisfaction sex: ALL minimumAge: 3 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06306313 id: ReoGo briefTitle: Effects of Robot-Assisted Rehabilitation on Upper Extremity Functions in Chronic Stroke overallStatus: RECRUITING date: 2024-03-07 date: 2024-05-07 date: 2024-05-14 date: 2024-03-12 date: 2024-04-05 name: Pamukkale University class: OTHER briefSummary: The most common problem caused by stroke is motor activity limitation that reduces muscle movement and mobility. But stroke can also lead to sensory and cognitive impairment. Additionally, the ability to independently carry out activities of daily living and participate in social and community life is greatly reduced. Up to 85% of stroke patients experience hemiparesis immediately after stroke, while 55% to 75% of survivors continue to experience reduced quality of life with motor impairments.

It requires long-term physical rehabilitation to achieve functional recovery in the upper extremity, maximum independence and the highest possible quality of life. Different methods can be used to achieve these results, but there is no clear evidence yet as to which treatment method gives the best results. Scientific evidence shows that a multifactorial approach and high-intensity treatment accelerates the motor recovery of the upper extremities in stroke rehabilitation. Passive and active upper extremity movements appear to increase motor recovery due to their effects on somatosensory input, motor planning, soft tissue properties and spasticity.

In recent years, robotic devices have emerged that have been proven to improve the motor performance of the upper extremity in chronic stroke patients. There are also studies showing that robotic device-assisted upper extremity therapy can contribute to the development of sensorimotor skills in plegic patients. However, in the current literature, there is still a need for randomized controlled studies in this field. The aim of this study is to investigate the effects of robot-assisted therapy on upper extremity functions and daily living activities in the rehabilitation of chronic stroke patients. After the demographic data of the cases in both groups are obtained, evaluations will be made before the study. Then, the study group will receive conventional physiotherapy in a single session of 45 minutes a day, 3 days a week for 4 weeks, and in addition robot-assisted therapy with the ReoGo Upper Extremity Exoskeleton Robot in a single session of 60 minutes a day, 5 days a week for 4 weeks. The control group will receive only conventional physiotherapy in a single session of 45 minutes a day, 3 days a week for 4 weeks. The initial evaluations will be repeated after the end of the treatment period. conditions: Stroke conditions: Upper Extremity Paresis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 24 type: ESTIMATED name: ReoGo name: Conventional Physiotherapy measure: Fugl Meyer Upper Extremity Evaluation Scale measure: Functional Independence Scale sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pamukkale University status: RECRUITING city: Denizli country: Turkey name: Fatih Tekin, Prof. role: CONTACT phone: +90258 296 4264 email: fzt.ftekin@hotmail.com lat: 37.77417 lon: 29.0875 hasResults: False

 nctId: NCT06306300 id: 445957/2020-4 briefTitle: Safety and Efficacy of Decentralized HCV Treatment vs Standard-of-Care in Rio de Janeiro (Brazil) acronym: HCVPCL05/20 overallStatus: RECRUITING date: 2022-07-04 date: 2025-12-31 date: 2025-12-31 date: 2024-03-12 date: 2024-03-25 name: Oswaldo Cruz Foundation class: OTHER name: Conselho Nacional de Desenvolvimento Científico e Tecnológico briefSummary: Up to 650,000 people in Brazil are living with chronic hepatitis c virus (HCV) infection. Hepatitis C is a silent disease, and up to 20% of cases can progress to liver cirrhosis and its complications. Rapid tests for diagnosis of HCV infection and non-invasive methods for detecting liver cirrhosis are available in the Brazilian Public Health System. Additionally, safe and highly effective drugs (direct-acting antivirals, DAAs) have been delivered for free for hepatitis C treatment by the Brazilian Unified Health System (Sistema Único de Saúde, SUS) since 2015. Sustained virological response (SVR) rates with DAAs in studies conducted in Brazil and Latin America were higher than 90%. Despite the availability of rapid tests for early diagnosis and effective drugs, the HCV continuum of care remains deficient in Brazil. It is estimated that only 10% of individuals known to have hepatitis C achieve HCV cure (SVR). This is explained by multiple barriers from diagnosis to treatment access, such as low rates of population screening (HCVST are not available in Brazil) and few available slots in tertiary centers for hepatitis C treatment by specialists. International studies have described that SVR rates by simplified hepatitis C treatment performed by non-specialists in the Primary Care System were similar to those treated in tertiary centers by specialists (standard-of-care). However, the optimal strategy for managing hepatitis C within the Brazilian-SUS remains unclear.This project aims to evaluate the improve of the HCV continuum of care by a implementation of a test-and-treat strategy in the Primary Care System in Brazil. The project consists of two parallel studies (and a sub-study).

The project consists of two parallel studies (and a sub-study). Study I is a population-based cross-sectional screening study using rapid tests to determine the prevalence of HCV infection in people attending a Basic Health Care Unit. The sub-study associated with Study I is a cross-sectional study to assess the usability of a self-test for the detection of HCV antibodies in oral fluid (participants included in Study I). Study II is a phase IV open-label randomized clinical trial to evaluate the non-inferiority of simplified and decentralized hepatitis C treatment ("Simplified-and-Decentralized (SD) HCV treatment"; experimental arm) compared to specialist reference treatment ("Standard-of-Care (SC) HCV treatment"; control arm) within the SUS. conditions: Hepatitis C studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Study I is a population-based cross-sectional screening study (n=30,000 individuals) to determine the prevalence of HCV infection in people attending a Basic Health Care Unit. The sub-study associated with Study I is a cross-sectional study to assess the usability of a self-test for the detection of HCV antibodies in oral fluid (n=1,500 participants included in Study I). Study II is a phase IV open-label randomized clinical trial (1:1) to evaluate the non-inferiority of simplified and decentralized hepatitis C treatment ("Simplified-and-Decentralized (SD) HCV treatment"; experimental arm) compared to specialist reference treatment ("Standard-of-Care (SC) HCV treatment"; control arm) within the SUS. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 30000 type: ESTIMATED name: Specialist - Epclusa 400Mg-100Mg Tablet name: Non- specialist - Epclusa 400Mg-100Mg Tablet measure: Prevalence of HCV infection measure: The effectiveness of the HCV treatment with test results. measure: Usability of the result of a self-test HCV measure: Proportion between positive and negative measure: Participants with fibrosis/cirrhosis measure: Participants who denied the treatment measure: cost per detected participant measure: Unscheduled visits during treatment measure: Improvement of liver fibrosis stage measure: Quality of life data measure: Cost of treatment for participant measure: Adherence to treatment measure: Participant´s Ability to use the test measure: Participant preference for types of tests measure: Participant understanding to interpret his result measure: Test Performance measure: Test Accuracy sex: ALL minimumAge: 18 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Evandro Chagas National Institute of Infectious Diseases status: RECRUITING city: Rio de Janeiro state: Rio De Janeiro/RJ zip: 21040-360 country: Brazil name: Hugo Perazzo, PhD role: CONTACT phone: +5521 3865-9587 email: hugo.perazzo@ini.fiocruz.br lat: -22.90278 lon: -43.2075 facility: Hugo Perazzo status: RECRUITING city: Rio De Janeiro country: Brazil name: Hugo Perazzo, PhD role: CONTACT phone: +552138659587 email: hugo.perazzo@ini.fiocruz.br lat: -22.90278 lon: -43.2075 hasResults: False

 nctId: NCT06306287 id: DA053660 briefTitle: Adolescent Screening and Personalized Intervention Resource for Enhancement of Behavioral Health and Substance Use acronym: ASPIRE overallStatus: RECRUITING date: 2024-02-15 date: 2024-11-30 date: 2025-04-30 date: 2024-03-12 date: 2024-04-22 name: Oregon Research Institute class: OTHER briefSummary: Only a small fraction of youth who are beginning to experience behavioral health problems and use alcohol or illicit drugs receive needed treatment services due to the lack of accessible, effective early intervention resources. The goal of this clinical trial is to compare a personalized brief web-based early intervention, eHealth Personalized Approach for Change Efficacy (ePACE), in which youth are offered choices regarding intervention content and desired level of engagement, to a "fixed", non-tailored brief intervention, eHealth Fixed Approach for Change Efficacy (eFACE) for adolescents with mild/moderate substance use and common co-occurring problems. Both ePACE and eFACE include a multi-problem screener that guides youths through a set of key integrated behavior change and counseling modules providing a cohesive focus on these four problem domains: drug abuse, interpersonal relations, negative emotions and stress. The main questions the trial aims to answer are:

* Are substance use and co-occurring problem outcomes for ePACE and eFACE are superior to those for a waitlist comparison group (WC)
* Are outcomes for ePACE are superior to those for eFACE
* Are the direct effects of ePACE and eFACE (i.e., the improvements in substance use and co-occurring problem outcomes) associated with improvements in areas of functioning and new skills that are hypothesized to produce change -- that is, are the improvements shown in the ePACE and eFACE groups due to the mechanisms by which change is hypothesized to occur Participants in ePACE and eFACE will complete a baseline assessment prior to engaging in the intervention to which they are assigned and will complete post-intervention assessments 3 months and 6 months later. Participants in the WC group will complete three assessments: at baseline, 3-months, and 6-months. conditions: Substance Use conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Youth (n=120) will be randomly assigned to one of three conditions (40 youths per condition): ePACE, eFACE, or waitlist comparison (WC) condition. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The investigators and the assessors will not have access to the conditions to which participants are assigned until all data are collected. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: ePACE Personalized Intervention name: eFACE Fixed Intervention measure: Adolescent Substance Use from baseline to 3 months measure: Adolescent Substance Use from baseline to 6 months measure: Youth Report of Internalizing Problems from baseline to 3 months measure: Youth Report of Internalizing Problems Change from baseline to 6-months measure: Youth Report of Externalizing Problems from baseline to 3-months measure: Youth Report of Externalizing Problems from baseline to 6-months measure: Parent Report of Internalizing Problems from baseline to 3-months measure: Parent Report Internalizing Problems from baseline to 6-months measure: Parent Report Externalizing Problems from baseline to 3-months measure: Parent Report Externalizing Problems from baseline to 6-months measure: Problem-Solving Inventory from baseline to 3-months measure: Problem-Solving Inventory from baseline to 6-months measure: Child Global Assessment Scale (CGAS) from baseline to 3-months measure: Child Global Assessment Scale (CGAS) from baseline to 6-months measure: Peer Encouragement and Influence from baseline to 3 months measure: Peer Encouragement and Influence from baseline to 6 months measure: Emotion Regulation from baseline to 3 months measure: Emotion Regulation - baseline to 6 months measure: Change in Urine assay - baseline to 3 months measure: Change in Urine assay - 3 months to 6 months sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Oregon Research Institute status: RECRUITING city: Albuquerque state: New Mexico zip: 87109 country: United States name: Holly B Waldron, PhD role: CONTACT phone: 541-915-6196 email: hwaldron@ori.org name: Aleah A Montano, MA role: CONTACT phone: 5054538984 phoneExt: Waldron email: hollybarrettwaldron@gmail.com name: Holly B Waldron, PhD role: PRINCIPAL_INVESTIGATOR name: Ken C Winters, PhD role: PRINCIPAL_INVESTIGATOR name: Timothy J Ozechowski, PhD role: SUB_INVESTIGATOR name: Hyman Hops, PhD role: SUB_INVESTIGATOR lat: 35.08449 lon: -106.65114 hasResults: False

 nctId: NCT06306274 id: TACLE trial briefTitle: Topical Tacrolimus for Breast Cancer-related Lymphedema overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-11-30 date: 2025-11-30 date: 2024-03-12 date: 2024-03-12 name: Odense University Hospital class: OTHER briefSummary: The goal of this clinical trial is to investigate the effect of tacrolimus ointment in women with stage I or II breast cancer-related lymphedema. The main question it aims to answer are:

* How tacrolimus affects breast cancer related lymphedema regarding subjective and objective measures (e.g. arm volume, lymphedema index, lymphatic function, and quality of life).
* If maintenance treatment is effective. Participants will be treated with either active drug or placebo once daily for six months followed by a six month maintenance periode with treatment twice weekly. Assessments will be performed at baseline, three, six, nine and 12 months. conditions: Lymphedema studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Tacrolimus name: Placebo measure: Lymphedema volume sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Odense University Hospital city: Odense zip: 5000 country: Denmark name: Frederik Gulmark Hansen role: CONTACT phone: +4521734450 email: frederik.c.gulmark.hansen@rsyd.dk lat: 55.39594 lon: 10.38831 facility: Zealand University Hospital city: Roskilde zip: 4000 country: Denmark name: Michael Rose role: CONTACT lat: 55.64152 lon: 12.08035 facility: Lillebaelt Hospital city: Vejle zip: 4000 country: Denmark lat: 55.70927 lon: 9.5357 hasResults: False

 nctId: NCT06306261 id: TIMAEUS briefTitle: Controlling the Mental Health for a Better Response to Treatment in Patients With Ulcerative Colitis acronym: TIMAEUS overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-08 date: 2025-03-15 date: 2024-03-12 date: 2024-03-12 name: IRCCS San Raffaele class: OTHER briefSummary: The project aims to implement the Internet Of Thing (IoT) platform of the San Raffaele Hospital (OSR) with data from stress conditions perceived by the patient through the synergistic collaboration between patients, gastroenterologists and psychologists. conditions: Ulcerative Colitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: questionnaire measure: to evaluate mental stress/health as an impacting factor on UC progression sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Irccs Ospedale San Raffaele city: Milano zip: 20132 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06306248 id: PNRR-MAD-2022-12375716 briefTitle: Immune Activation, Neural Plasticity and Depression overallStatus: RECRUITING date: 2023-03-03 date: 2025-03-03 date: 2025-05-09 date: 2024-03-12 date: 2024-03-12 name: IRCCS San Raffaele class: OTHER briefSummary: Major depressive disorder (MDD) is a chronic, recurring and potentially life-threatening illness that affects up to 10% of the population across the globe.Increasing evidence indicates a clear link between immune dysfunction and MDD.Moreover, an activation of inflammatory pathways is associated to a lack of clinical response to antidepressants. Thus, the regulation of inflammation represents a potential approach to modulate the link between the living environment and antidepressant outcome. Light therapy combined with sleep deprivation hastens recovery, with benefits that can be perceived by patients during the first week of treatment. Alteration of the sleep-wake cycle and of sleep structure are core symptoms of MDD.The aims of the present project are (i) to show that neural plasticity and the environmental context are moderating factors of the therapeutic outcome of immune modulation and (ii) to exploit their interplay to set up novel and effective therapeutic strategies for MDD.This is a observational prospective study with non-invasive add-on procedures (Magnetic Resonance without contrast). In this study, 60 patients with a depressive episode in course of MDD and treated with a chronobiological intervention including total sleep deprivation (TSD) + light therapy (LT), as performed in clinical practice, will be studied. All participants enrolled in the study will receive Treatment As Usual (TAU), i.e., pharmacotherapy, chronobiological intervention plus clinical management. Drug prescription will be performed during the clinical management sessions.The study will have a total duration of 24 months. Each subject will participate in the study for 6 months, will undergo Magnetic Resonance Imaging (MRI) and clinical evaluation at baseline, after one week of chronobiological treatment and at 6 months follow-up. conditions: Mood Disorders conditions: Major Depressive Disorder conditions: Sleep Deprivation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Total sleep deprivation measure: BENEFICIAL EFFECT OF total sleep deprivation in inflamed vs non inflamed patients. measure: Neurobiological markers of prediction and progression of antidepressant treatment sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale San Raffaele status: RECRUITING city: Milan state: Mi zip: 20132 country: Italy name: Sara SP Poletti, phd role: CONTACT phone: 390226433156 email: poletti.sara@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06306235 id: 20.84-reva20.06 briefTitle: Are Non-participants of Conventional Centre-based Cardiac Rehabilitation Willing to Participate in Cardiac Telerehabilitation? overallStatus: COMPLETED date: 2020-10-12 date: 2021-07-31 date: 2021-07-31 date: 2024-03-12 date: 2024-03-12 name: Jessa Hospital class: OTHER briefSummary: Patients who are eligible for cardiac rehabilitation but do not want to participate will be offered to participate in an interview (part A of the study) or a tablet questionnaire (part B of the study).

Goal is to identify main barriers for conventional rehabilitation as well as to assess willingness to participate in cardiac telerehabilitation, main barriers and willingness-to-pay for cardiac telerehabilitation. conditions: Cardiac Rehabilitation studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 60 type: ACTUAL name: Questionnaire measure: Willingness to participate in telerehabilitation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Jessa Hospital city: Hasselt state: Limburg zip: 3500 country: Belgium lat: 50.93106 lon: 5.33781 hasResults: False

 nctId: NCT06306222 id: GR-2021-12375430 briefTitle: Thulium Fiber Laser vs. Holmium:YAG Laser for the Ureteroscopic Treatment of Patients With Urinary Stone Disease overallStatus: RECRUITING date: 2023-11-23 date: 2025-11-23 date: 2026-02-23 date: 2024-03-12 date: 2024-03-12 name: IRCCS San Raffaele class: OTHER briefSummary: This is a randomized controlled trial which aims to compare the efficacy and safety of Thulium fiber laser (TFL) and holmium:yttrium-aluminum-garnet (Ho:YAG) laser ablation during the treatment of upper urinary tract stone disease with flexible ureteroscopy, demonstrating clinical superiority of TFL. conditions: Kidney Stone conditions: Ureteral Stone studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 120 type: ESTIMATED name: Laser lithotripsy measure: Lithotripsy speed measure: Stone free rate sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale San Raffaele status: RECRUITING city: Milan country: Italy name: Alessia D'Arma role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06306209 id: DeFLAME briefTitle: Inflammatory Control of Antidepressant Efficacy: a Pharmaco-epigenetic Approach overallStatus: RECRUITING date: 2021-05-18 date: 2024-11-30 date: 2025-01-14 date: 2024-03-12 date: 2024-03-12 name: IRCCS San Raffaele class: OTHER briefSummary: Major depressive disorder (MDD) is a chronic, recurring and potentially life-threatening illness that affects up to 10% of the population across the globe.It posits that the increase in serotonin levels induced by Selective Serotonin Reuptake Inhibitors (SSRIs) does not affect mood per se, but enhances brain plasticity and thus amplifies the influence of the environment on the individual. Thus, SSRI treatment has not a univocal effect but, in a favorable environment, it would lead to a reduction of symptoms while in a stressful environment might lead to a worse prognosis.Such innovative view opens new perspectives on how to improve SSRI efficacy by controlling the environment. However, often it is not possible to act on the quality of the living environment because of constraints due to patient's personal history and unchangeable life circumstances. In these cases, the pharmacological modulation of the factors underlying the link between living environment and SSRI efficacy represents a novel and desirable strategy to improve treatment outcome even in patients living in adverse conditions, which are very common in depressed patients. Inflammatory levels are markedly affected by the socioeconomic status and thus by the quality of the living environment. The hypothesis of the present project is that inflammation mediates the influence of the environment on SSRI outcome.Therefore, the control of inflammatory levels is a promising strategy to improve treatment efficacy and overcome the limited SSRI efficacy, especially when administered in patients living in adverse conditions. A further hypothesis is that the influence of the environment on inflammation, in turn affecting SSRI efficacy, occurs through epigenetic modifications. Therefore, the project aims at developing a pharmaco-epigenetic approach as effective treatment for MDD. In addition, through neuroimaging investigations, it will provide important information about functional and structural brain modifications associated to SSRI efficacy in patients.

Both males and females will be considered because MDD is twice as common in women than men, suggesting that different mechanisms may underlie the psychopathology in the two sexes. conditions: Mood Disorders conditions: Major Depressive Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Treatment as usual (TAU), i.e., pharmacotherapy plus clinical management measure: The potential role of inflammation as the causal link between the quality of the environment and SSRI efficacy measure: interaction between early stress and recent stress on the response to treatment and the role of inflammation measure: identification of neurobiological predictors of response to treatment measure: identification of neurobiological predictors of response to treatment measure: identification of neurobiological predictors of response to treatment measure: epigenetic changes in cytokine regulating genes which could mediate the effect of stress on response to treatment. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale San Raffaele status: RECRUITING city: Milan state: Mi zip: 20132 country: Italy name: Sara sp Poletti, phd role: CONTACT phone: +390226433156 email: poletti.sara@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06306196 id: IVI Hecolin S001 briefTitle: Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adults and in Children overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-01 date: 2026-01 date: 2024-03-12 date: 2024-03-12 name: International Vaccine Institute class: OTHER name: Xiamen Innovax Biotech Co., Ltd name: Bill and Melinda Gates Foundation briefSummary: The primary goal of this clinical trial is to demonstrate non-inferiority of 30 µg of Hecolin® in healthy children, compared to healthy adults as measured by seroresponse rates (SR) of anti-HEV IgG titers, 4 weeks after 3 doses (0, 1 and 6 months) and to assess and descriptively compare safety profile data intra and inter age Strata. As secondary objectives, Geometric Mean Concentration (GMC) of anti-HEV IgG ELISA will be evaluated 4 weeks after 3 doses (0, 1 and 6 months) and 4 weeks after 2 doses (0- and 6-months dose) in healthy children. SR and GMC will also be evaluated 24 weeks after 3 doses and 2 doses. The immune response will be compared among adult participants between HIV positive and HIV negative individuals and between virally suppressed and virally unsuppressed HIV positive individuals conditions: Hepatitis E Virus Infection studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Single whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 860 type: ESTIMATED name: Hecolin® Recombinant Hepatitis E Vaccine name: Isotonic Sodium Chloride injection measure: Seroresponse rate measure: Proportion of immediate adverse events measure: Proportion of solicited local and systemic adverse events measure: Proportion of unsolicited adverse events measure: Proportion of SAEs, MAAEs and AESIs measure: GMC of anti-HEV IgG measure: SR measure: GMC of anti-HEV IgG measure: SR and GMC of anti-HEV IgG measure: SR measure: GMC of anti-HEV IgG measure: SR measure: GMC of anti-HEV IgG measure: SR measure: GMC of anti-HEV IgG measure: SR measure: GMC of anti-HEV IgG measure: SR and GMC of anti-HEV IgG measure: SR and GMC of anti-HEV IgG measure: Safety in all participants as per gender distribution and serostatus sex: ALL minimumAge: 2 Years maximumAge: 45 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06306183 id: 2024-2829 briefTitle: Effect of Vitamin C on Pain Reduction After an Emergency Department Visit acronym: Vicamed overallStatus: NOT_YET_RECRUITING date: 2024-11 date: 2026-11 date: 2028-03 date: 2024-03-12 date: 2024-03-12 name: Hopital du Sacre-Coeur de Montreal class: OTHER name: Hopital de l'Enfant-Jesus name: The Ottawa Hospital briefSummary: Emergency department (ED) clinicians often prescribe anti-inflammatory drugs (NSAIDs) to manage acute musculoskeletal (MSK) pain (e.g.: fracture, sprain, back pain). However, even short-term NSAIDs use can have significant gastrointestinal, cardiovascular, MSK and renal adverse effects. For this reason, some patients cannot take or tolerate NSAIDs. Recent evidence has shown that vitamin C has some analgesic and anti-inflammatory properties particularly in postoperative context and prevent specific types of chronic pain. Furthermore, vitamin C is safe and associated with very few adverse events. The primary objective of this study is to determine whether vitamin C can reduce pain intensity during a seven-day period following an ED visit for acute MSK pain.

The investigators propose to compare two groups of patients, one receiving 900 mg of vitamin C to another receiving a placebo, twice a day for seven days. Both groups will consume acetaminophen slow release 650 mg two pills every eight hours regularly. Naproxen 500 mg (NSAID) will be used as a rescue medication if the patient's pain is not relieved. Participants will be ≥18 years of age, treated in ED for acute MSK pain present for less than 48 hours with pain intensity at triage of ≥ 4 on a 0-10 numeric rating scale, and discharged by an ED clinician with an NSAIDs prescription without opioids. The level of pain intensity during a seven-day period will be assessed daily using an electronic or paper diary, as well as pain relief, pain medication consumption, and adverse events. Three months after the injury, participants will also be contacted to assess the presence of chronic pain. The investigators hypothesized that vitamin C will reduce pain intensity and chronic pain development at three months.

This research could provide a safe alternative to patients who are unable to take NSAIDs. It may also contribute to the reduction of the burden associated with chronic pain development. conditions: Pain, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-blind randomized placebo-controlled trial primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 546 type: ESTIMATED name: Acetaminophen and Vitamin C with Naproxen rescue name: Acetaminophen and Placebo with Naproxen rescue measure: Daily pain intensity measure: NSAIDs consumption measure: Pain relief measure: New analgesic prescriptions measure: Adverse events measure: Quality of life improvement at seven days measure: Quantity of Healthcare visits measure: Prevalence of chronic pain measure: Prevalence of complex regional pain syndromes for limb fractures measure: Quality of life improvement at 90 days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hopital du Sacre-Coeur de Montreal city: Montreal state: Quebec zip: H4J 1C5 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06306170 id: GYN-ART briefTitle: Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART) acronym: GYN-ART overallStatus: RECRUITING date: 2024-02-15 date: 2027-02-15 date: 2029-02-15 date: 2024-03-12 date: 2024-03-12 name: IRCCS San Raffaele class: OTHER briefSummary: This is an observational mono-institutional study. Patients with gynecologic tumors treated with advanced radiotherapy- Image Guided Radiotherapy (IGRT), Intensity Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT)- will be included and toxicity and outcomes analyzed. conditions: Gynecologic Cancer conditions: Radiotherapy Side Effect conditions: Radiotherapy; Complications conditions: Survivorship conditions: Progression, Disease conditions: Progression, Clinical studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: Image Guided Radiotherapy measure: Local Relapse Free Survival measure: Regional Relapse Free Survival measure: Distant Metastases Free Survival measure: Disease Free Survival measure: Overall Survival measure: Cancer Specific Survival measure: Acute toxicity measure: Late toxicity measure: Predictive factors for disease progression and death measure: Radiomic predictive factors for disease progression and death sex: FEMALE minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: San Raffaele Scientific Institute status: RECRUITING city: Milan state: MI zip: 20132 country: Italy name: Andrei Fodor, M.D. role: CONTACT phone: +390226437634 email: fodor.andrei@hsr.it name: Nadia G Di Muzio, Prof role: CONTACT phone: +390226437643 email: dimuzio.nadia@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06306157 id: 2023-0667 briefTitle: Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome acronym: LDN-CRPS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-07 date: 2026-10 date: 2024-03-12 date: 2024-03-12 name: Hospital for Special Surgery, New York class: OTHER briefSummary: Complex Regional Pain Syndrome (CRPS) is a rare and often debilitating chronic pain condition whereby individuals may experience extreme sensitivity, discoloration, and swelling of the affected area -- along with numerous other painful symptoms. There are currently a limited number of treatment options available to those suffering with the condition, with various treatments including nerve blocks, neuropathic medications, and desensitization physical therapy modules. There is budding interesting in the role naltrexone, an opiate antagonist, may play in the pain management of CRPS when prescribed in very low doses. This study aims to collect preliminary data on pain scores, symptom severity, and side-effects in patients with Complex Regional Pain Syndrome randomized to receive low dose naltrexone or placebo capsules. Enrollment of 40 patients total will occur over two years from study start to study end. Each patient will be randomized to receive placebo capsules or active low dose naltrexone capsules, with both the patient and treating clinician blind to the randomization. Each patient will be actively enrolled in the study for six months and will take the medication daily at the instructed dose for the respective duration of time. Following the initial visit and study enrollment, the investigators are asking each patient to return for three (3) in-person follow-up office visits. These office visits will occur 1 month after the patient starts the medication, 3 months afterwards, and 6 months afterwards. The final 6-month office visit will mark the conclusion of the patient's active participation in the study. conditions: Complex Regional Pain Syndrome conditions: Chronic Pain conditions: Causalgia conditions: Complex Regional Pain Syndrome Type I conditions: Complex Regional Pain Syndrome Type II studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a feasibility, randomized, placebo-controlled interventional drug study. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: A quadruple blinded study where the patient, research team, treating clinician, and outcomes assessor are unaware of the randomization results until after study conclusion. The research pharmacy will not be blinded and will be responsible for preparing the medication and securely handing it off to the research assistant according to the pre-approved dispensation plan. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Low dose naltrexone name: Placebo sugar capsules measure: Number of study patients enrolled measure: Number of study patients randomized measure: Number of study patients who received the study medication measure: Incidence of side effects/adverse events measure: Average NRS pain measure: CRPS symptom severity measure: PROMIS-10 score measure: S-LANSS score measure: Blinding assessment measure: Enrollment rate measure: Study medication compliance measure: Reasons for study medication non-compliance measure: Drop-out rate measure: Reasons for drop-out sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital for Special Surgery city: New York state: New York zip: 10021 country: United States name: Marlena Komatz role: CONTACT phone: 646-714-2901 email: komatzm@hss.edu lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06306144 id: 69HCL23_0691 briefTitle: Early-phase Telecare Programs for Minor Stroke acronym: COGaDOM overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-07-01 date: 2027-07-01 date: 2024-03-12 date: 2024-04-18 name: Hospices Civils de Lyon class: OTHER briefSummary: Minor strokes (few acute neurological symptoms ; NIHSS score \<5), represent almost 65% of cerebrovascular ischemic events. The increasing incidence of stroke in people under 65, together with advances in diagnostic and revascularization techniques, mean that post-stroke life expectancy is now in the order of decades. Most patients with minor stroke are rapidly discharged from hospital, with follow-up focused on secondary prevention and they are offered little or no rehabilitation.

However, up to 70% of patients with minor stroke experience difficulties resuming their social or professional activities, which can lead to social and economic disruption (delayed/compromised return to work) and an increased risk of depression. While some care recommendations exist for this population, in France there is no consensus nor identified care pathway for follow-up assessment or management of these patients. Furthermore, existing services are unevenly distributed across the country, and research into the effectiveness of rehabilitation is still scarce, leading to uncertainty as to which interventions should be prioritized to decrease difficulties related to cognitive impairment.

Since there are currently no rehabilitation proposals in France for patients with mild cognitive impairment after mild stroke, in this trial the investigaror will investigate the effectiveness of two six-week telerehabilitation programs each consisting of a weekly session supervised by a therapist and a self-rehabilitation session. The aim of this multicenter randomized controlled trial is the evaluate the relevance and feasibility of early identification of patients eligible for a cognition-focused management proposal and the efficacy of two telecare programs, (a) psychoeducation and (b) computerized cognitive rehabilitation. conditions: Minor Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 80 type: ESTIMATED name: Psychoeducation name: Computerised Cognitive Stimulation name: Usual Care measure: The primary objective of this study is to demonstrate the benefits of early management following a minor stroke on participation at 6 months post-stroke. measure: to evaluate the effects on quality of life of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) measure: to evaluate the effects on cognitive complaint of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) measure: to evaluate the effects on cognitive function of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) measure: to evaluate the effects on mood and anxiety of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) measure: to evaluate the effects on fatigue of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) measure: to evaluate the effects on participation of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) measure: to evaluate the effects on health status of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) measure: to evaluate the effects on health status of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Bordeaux city: Bordeaux zip: 33000 country: France name: GLIZE Bertrand role: CONTACT phone: 05 56 79 56 79 email: bertrand.glize@chu-bordeaux.fr lat: 44.84044 lon: -0.5805 facility: CHU Lille city: Lille zip: 59037 country: France name: ALLART Etienne, Dr role: CONTACT phone: 03 20 44 48 71 email: etienne.allart@chu-lille.fr lat: 50.63297 lon: 3.05858 facility: Hôpital Henry Gabrielle city: Saint-Genis-Laval zip: 69230 country: France name: PUGNIET Virginie role: CONTACT phone: 04.78.86.50.64 email: virginie.pugniet@chu-lyon.fr lat: 45.69558 lon: 4.7934 hasResults: False

 nctId: NCT06306131 id: IG-23-002 id: 1R43HD107861-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R43HD107861-01A1 briefTitle: Phase II Study of Ovulation in Obese Women overallStatus: RECRUITING date: 2023-12-10 date: 2024-12-01 date: 2025-01-31 date: 2024-03-12 date: 2024-03-12 name: InnovaGyn, Inc. class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: The goal of this clinical trial is to compare the delay in ovulation between placebo to levonorgestrel plus meloxicam in obese women with normal menses. The main questions it aims to answer are:

1. Ovulation will be delayed by ≥7 days following the first dose of levonorgestrel plus meloxicam compared to ovulation within 3 days following the first dose of placebo.
2. There will be no difference in unscheduled vaginal bleeding or adverse events between the two treatments \[placebo versus levonorgestrel plus meloxicam\].

Participants will:

* undergo two treatment cycles the 1st uses placebo and the 2nd is levonorgestrel plus meloxicam,
* maintain daily diary logs for adverse events, unscheduled bleeding, and onset, cessation, and amount of menstrual bleeding,
* collect daily first morning voided urine from menstrual day 9 to 24,
* undergo transvaginal ultrasound for ovarian follicle development on menstrual days 9, 11,13 and 14.
* allow a blood sample to be drawn on days with ultrasound scans.
* Take 1st placebo and levonorgestrel plus meloxicam under observation when dominant ovarian follicle is 17 ±1.0 millimeters (mm) in diameter and 2nd dose 48 hours later.

Researchers will compare the placebo cycle to levonorgestrel plus meloxicam to see if ovulation is delayed, there is unscheduled vaginal bleeding, menstrual onset is delayed or there is an abnormal amount or duration of menses, there is any difference in treatment emergent side effects and any change in vital signs conditions: Pregnancy Prevention studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Placebo controlled in first cycle with levonorgestrel plus meloxicam in second menstrual cycle. primaryPurpose: OTHER masking: SINGLE maskingDescription: The intervention will be masked to the laboratory preforming the analysis of the urinary metabolites. The statistician, clinicians, coordinators and participants will be aware of the medication being studied. whoMasked: OUTCOMES_ASSESSOR count: 22 type: ESTIMATED name: Levonorgestrel 0.15 milligram name: Meloxicam 15 milligram name: calcium carbonate 750 milligram measure: Interval from first dose to evidence of ovulation. measure: Change in blood pressure measure: Change in Pulse measure: Unscheduled endometrial bleeding and changes in interval, amount and duration of menstrual bleeding. sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Carolina Women's Research and Wellness Center status: RECRUITING city: Raleigh state: North Carolina zip: 27713 country: United States name: Andrea S. Lukes, MD role: CONTACT phone: 919-251-9223 email: andrealukes@cwrwc.com name: Janet F. Davis role: CONTACT phone: 9192519223 email: janet@cwrwc.com name: Andrea S. Lukes, MD role: PRINCIPAL_INVESTIGATOR lat: 35.7721 lon: -78.63861 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-04-17 uploadDate: 2023-10-16T10:12 filename: ICF_000.pdf size: 336680 hasResults: False

 nctId: NCT06306118 id: 35-046 ex 22/23 briefTitle: Autoguide Positioning Device for Multiple Stereotactic Biopsies acronym: AMB overallStatus: RECRUITING date: 2024-04-15 date: 2025-02 date: 2025-10 date: 2024-03-12 date: 2024-03-12 name: Medical University of Graz class: OTHER briefSummary: The purpose of this clinical study should be that, in the context of planned resections of glial brain tumors, pieces of tissue (biopsies) are removed from the tumor at several specific locations before the actual tumor resection takes place.

The aim of these biopsies in advance to the actual tumor resection will be to receive tumor tissue samples not altered in such a way that it is no longer adequate for further treatment. If not adequate, a so-called "undergrading" could occur, which means that the biological structure of the tumor is misjudged and further therapy does not achieve the desired effect in the patient.

On the one hand, certain tumor regions can drift due to a "brain shift" which leads to inaccurate tissue removal, and on the other hand samples are not altered by pressure or bleeding.

To carry out these biopsies, a robot positioning device (AutoGuide®) will be used that has already been approved and tested for this type of intervention. The use of the AutoGuide® is intended to ensure that the tumor sample is taken with the greatest possible precision. conditions: Multiple Stereotactic Tumor Biopsies During a Brain Tumor Resection studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: Multiple stereotactic Tumor Biopsies during a Brain Tumor Resection measure: Biopsy Results sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Graz status: RECRUITING city: Graz state: Styria zip: 8036 country: Austria name: Stefan Wolfsberger, Prof. role: CONTACT phone: +43031638583102 email: stefan.wolfsberger@medunigraz.at lat: 47.06667 lon: 15.45 hasResults: False

 nctId: NCT06306105 id: 23-118-B briefTitle: Assessment of Anti-aging Efficacy of Marine Collagen Peptides overallStatus: RECRUITING date: 2024-03-04 date: 2024-10-31 date: 2024-12-01 date: 2024-03-12 date: 2024-03-19 name: TCI Co., Ltd. class: INDUSTRY briefSummary: To assess the anti-aging efficacy of Marine Collagen Peptides on skin, hair and finger nails for human conditions: Skin Condition conditions: Hair Fragility conditions: Nails, Ingrown studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Marine Collagen Peptides name: placebo drink measure: The change of skin hydation measure: The change of skin wrinkles measure: The change of skin elasticity measure: The change of skin collagen density measure: The change of hair diameters measure: The change of hair loss amount measure: The change of hair roots diameters measure: The change of hair density measure: The change of hair follicle strength measure: The change of thumbs nail color measure: The change of nails appearence measure: The change of nails growth measure: The degree of nails fragility measure: The change of self-assessment skin, hair, and nails condition sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chia Nan University of Pharmacy & Science status: RECRUITING city: Pingtung zip: 928 country: Taiwan name: Chia-Hua Liang role: CONTACT phone: +886-06-2664911 phoneExt: 2441 email: tinna_ling@mail.cnu.edu.tw name: Ping Lin role: CONTACT phone: +886-02-879778111 email: candice.lin@tci-bio.com lat: 22.67135 lon: 120.48814 hasResults: False

 nctId: NCT06306092 id: 2023-02885-01 briefTitle: Promoting Teenage Sleep for Improved Mental Health and School Performance acronym: TeenSleep overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2028-06 date: 2030-06 date: 2024-03-12 date: 2024-03-12 name: Kristianstad University class: OTHER name: Karolinska Institutet name: Örebro University, Sweden name: Academic Primary Health Care Centre, Region Stockholm briefSummary: The overall aim of this project is to evaluate the effectiveness of two school-based programs that have the potential to promote adolescent sleep and prevent future depressive symptoms. The programs will be offered to students aged 13-19 at Swedish high schools and upper secondary schools at the classroom level. The students will be compared to teaching as usual (control group). conditions: Mental Health Issue conditions: Insomnia conditions: Depression conditions: Anxiety conditions: Daytime Sleepiness conditions: Wellness, Psychological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 3000 type: ESTIMATED name: Sleep on Schedule name: Technology restriction measure: Change in sleep duration, hours and minutes measure: Change in Hospital Anxiety and Depression Scale scores measure: Change in Adolescent Sleep Hygiene Scale scores measure: Change in Insomnia Severity Index score measure: Change in EuroQol Visual Analog Scale (EQ VAS) score measure: Change in CHU9D Child Health Utility 9D (CHU9D) scores measure: Change in Sleep knowledge measure: Change in electronic media use measure: Change in sleep habits measure: Change in meta-cognitions measure: Change in motivation sex: ALL minimumAge: 13 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-23 uploadDate: 2024-03-07T03:17 filename: Prot_SAP_000.pdf size: 264890 hasResults: False

 nctId: NCT06306079 id: KKUMC id: Abdullah Al Assiri type: OTHER domain: King Khalid University Medical City id: Prof Pip Logan type: OTHER domain: Professor of Rehabilitation Research, University of Nottingham, UK. id: Professor Ana Valdes type: OTHER domain: Professor of Molecular & Genetic Epidemiology, University of Nottingham, UK. id: Dr. Benjamin Smith type: OTHER domain: Doctor of Physiotherapy, Division of Rehabilitation and Ageing, University of Nottingham. UK. briefTitle: Using Gait Modification to Treat Knee Osteoarthritis in Saudi Arabia: Possibilities and Acceptability. overallStatus: COMPLETED date: 2022-04-13 date: 2022-10-15 date: 2022-12-30 date: 2024-03-12 date: 2024-03-12 name: King Khalid University class: OTHER name: University of Nottingham briefSummary: A variety of biomechanical gait modification interventions can elevate knee loading and improve knee symptoms in knee osteoarthritis patients. However, there was a lack of acceptability and adherence regarding modification interventions without any explanation.

Thus, this study investigates the feasibility and acceptability of foot insoles as a gait modification tool among Saudi Arabian knee osteoarthritis patients and physiotherapists.

This study aims to answer the following:

* Which gait modification intervention is most likely to be implemented in Saudi Arabia (SA) clinical practice, taking context, patients' clinical and research evidence into consideration?
* In Saudi Arabia, can this proposed foot-insole intervention be implemented? Is there sufficient experience among physiotherapists regarding gait modification to deliver it, and will patients engage with it? How can KOA rehabilitation outcomes be evaluated in the future?

The participants will be conducted over three phases:

1. The patients' interview and therapists' focus group discussion will be used to examine KOA patients' and clinicians' perspectives on enabling and accepting gait modifications in phase 1.
2. The feasibility study will explore how a small number of KOA patients tolerate gait modifications and consider the most relevant outcome measures, such as pain and function, in phase (2).
3. A small group of knee osteoarthritis patients and their physiotherapists who participated in phase (2) will be asked to participate in a descriptive survey in phase (3). To examine the acceptability and feasibility of the study intervention in phase (2). conditions: Osteoarthritis, Knee conditions: Pain conditions: Biomechanical Lesion studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A gait modification (Lateral wedge insole) program will be conducted over 4 to 6 weeks in the physiotherapy gym or adjusted treadmill and outside the clinic during the day (at least 8 hours per day).

* During the session, the researcher will observe participants inside the clinic and ensure that the modified gait application is applied, and outside the clinic will be followed by telephone.
* Participants will walk on the gym floor or an adjusted treadmill for at least 15 to 20 minutes during each session. Participants will be instructed to use the mirror for feedback and achieve the target modified gait procedure. However, it will be emphasised gait modification procedures exhibited at baseline pain and function, and then at the end of the trial, it will focus on subjects' acceptability. primaryPurpose: OTHER masking: NONE count: 17 type: ACTUAL name: Lateral Wedge insole measure: Pain level measure: Western Ontario and McMaster Universities Arthritis Index-total measure: Likert scale measure: Likert scale sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: King Faisal Specialist Hospital & Research Centre city: Jeddah state: Western country: Saudi Arabia lat: 21.54238 lon: 39.19797 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-01-04 uploadDate: 2024-03-07T05:51 filename: Prot_000.pdf size: 234397 hasResults: False

 nctId: NCT06306066 id: 2015/962-31 briefTitle: Coronary Thermo-dilution Derived Flow-indices in Chronic Coronary Syndrome overallStatus: COMPLETED date: 2015-09-02 date: 2021-06-07 date: 2022-12-28 date: 2024-03-12 date: 2024-03-12 name: Karolinska Institutet class: OTHER name: Abbott briefSummary: Patients scheduled for elective coronary angiography due to chronic coronary syndrome are recruited at admission to hospital before the coronary anatomy is known. Immediately after coronary angiography measures thermo-dilution derived flow indices are obtained in the left left anterior descending artery (LAD). The patients are followed through telephone-calls and medical records at 1 and 2 years after inclusion and at completion of the study. The hypothesis is that elevated index of microcirculatory resistance (IMR),(\>25) is associated with all-cause death, myocardial infarction (MI) and hospitalization due to congestive heart failure (CHF).

The primary analysis is the relationship between IMR and the composite outcome all-cause death, MI and hospitalization due to CHF. conditions: Coronary Artery Disease conditions: Microvascular Angina conditions: Coronary Microvascular Dysfunction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 505 type: ACTUAL measure: Rate of all-cause mortality, MI and/or hospitalization due to CHF measure: Rate of all-cause mortality measure: Rate of hospitalization due to CHF. measure: Rate of all-cause mortality and/or MI measure: Rate of MI measure: Rate of stroke measure: Rate of ischemic stroke measure: Rate of unscheduled revascularization sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Danderyd University Hospital and Karolinska Institutet Danderyds University Hospital (KI DS) city: Stockholm zip: 182 88 country: Sweden lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06306053 id: 2022/ST/217 briefTitle: A New Treatment for Chronic Pain Combining Neuromodulation, Computer Assisted Training and Telemonitoring acronym: TechNoPain overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-01-31 date: 2026-04-30 date: 2024-03-12 date: 2024-03-12 name: ASST Santi Paolo e Carlo class: OTHER name: University of Milan name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico name: Istituto Europeo di Oncologia briefSummary: Chronic pain (CP) is a leading cause of medical disability, healthcare expenditure, and reduced psychological well-being. Given the limited mobility, travel burden, and cost, access to care can be problematic for patients suffering from this disease, driving the recent shift toward care through telehealth programs. Given the complex interrelationship of physical and psychosocial aspects related to chronic pain, in this project the investigators propose to validate and investigate the effectiveness of new integrated health interventions by combining the technique of transcranial direct current stimulation (tDCS), complementary therapies and telemonitoring. The investigators hypothesize that this novel combined approach will provide a more effective strategy to overcome the classic barriers of pharmacological treatments and access to healthcare due to lack of mobility. To do this, the investigators will rely on a previously developed integrated platform that enables effective delivery of non-pharmacological interventions and outcome assessment. Many patients do not benefit from pharmacological and invasive treatments, leading to the development of alternative therapeutic options such as non-invasive brain stimulation (e.g. tDCS) and complementary interventions to improve physical and psychological well-being. These complementary interventions reduced pain intensity and psychological distress by improving individuals' ability to manage and cope with their pain. However, due to the multiple co-occurring factors associated with chronic pain, a multidisciplinary and integrated treatment approach is challenging. Technology ecosystems can be a reliable tool to achieve such a diverse personalized approach and evaluate their results. In a previous project, the investigators developed PainRE-Life, a dynamic and integrated technology ecosystem to enable continuity of care for CP patients, including personalized applications, training tools and telemonitoring tools for outcome assessment. conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 126 type: ESTIMATED name: tDCS+EuleriaLab name: tDCS name: EuleriaLab measure: Visual Analogue Scale (VAS) measure: 12-item Short Form Survey (SF12) measure: Hospital Anxiety and Depression scale (HADS) measure: Brief Pain Inventory (BPI) measure: Pain Catastrophizing Scale (PCS) measure: Shared Decision-Making Questionnaire 9-Item (SDM-Q-9) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASST-Santi Paolo e Carlo Hospital city: Milan country: Italy name: Alberto Priori, PhD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico city: Milan country: Italy name: Fabiana Ruggiero, PsYD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Istituto Europeo di Oncologia city: Milan country: Italy name: Gabriella Pravettoni, PhD role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06306040 id: Analgesia effect as on EA briefTitle: Effect of Intravenous Nalbuphine and Magnesium Sulfate on Emergence Agitation in Pediatric overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2024-11-03 date: 2025-01-30 date: 2024-03-12 date: 2024-03-12 name: Assiut University class: OTHER briefSummary: • Primary outcome: Measure The incidence of EA in children undergoing to hypospadias repair under general anesthesia is considered using Pediatric Anesthesia Emergence Delirium (PAED) scales.

• Secondary outcome:

* Therefore, we designed a prospective, randomized, double-blind, single center study to investigate whether nalbuphine and/or magnesium sulphate can prevent EA after hypospadias repair in children under general anesthesia. In addition, the characteristics of anesthesia recovery and the incidence of adverse effects will also be evaluated in this study. Post-operative extubating time, interaction time, open eye time and emergence time. incidence of post-operative vomiting (PONV), laryngospasm, breath-holding, coughing, oxygen desaturation, and cardiac arrhythmias.
* Face, Legs, Activity, Cry and Consola Bility (FLACC) scale is used to determine post-operative pain score
* Parental satisfaction scores conditions: Emergence Delirium studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: * Group C (Control group n=35 ): 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery
* Group M (Magnesium sulfate group n=35 ): 30 mg/kg Magnesium sulphate diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery
* Group N (Nalbuphine group n=35 ): 0.1 mg/kg nalbuphine diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery primaryPurpose: PREVENTION masking: SINGLE maskingDescription: * Group C (Control group n=35 ): 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery
* Group M (Magnesium sulfate group n=35 ): 30 mg/kg Magnesium sulphate diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery
* Group N (Nalbuphine group n=35 ): 0.1 mg/kg nalbuphine diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery whoMasked: PARTICIPANT count: 105 type: ESTIMATED name: Nalbuphine Versus Magnesium Sulfate measure: compare between analgesia effect on pediatric patient sex: MALE minimumAge: 3 Years maximumAge: 7 Years stdAges: CHILD hasResults: False

 nctId: NCT06306027 id: 2023/024 briefTitle: The Impact of Web-Based Education on Self-Care Power, Self-Efficacy, and Quality of Life in Knee Arthroplasty Patients. overallStatus: RECRUITING date: 2024-03-01 date: 2024-07 date: 2024-12 date: 2024-03-12 date: 2024-03-12 name: KTO Karatay University class: OTHER briefSummary: The knee joint, which we use actively every day, is the largest joint in our body that bears the weight, allowing various movements such as walking, running, squatting, and standing. It involves the largest load-bearing structures in the body, including bones, cartilage, surrounding muscles, and ligaments, facilitating the mobilization of the joint. Due to constant use, the knee joint is susceptible to injuries and wear. Total knee arthroplasty (TKA) surgery involves replacing a degenerated joint surface, often due to conditions like osteoarthritis or rheumatoid arthritis, with a metal or polyethylene prosthesis. TKA, a widely used and highly successful surgical intervention in recent years, reduces pain, enhances functional range of motion, and improves independence and quality of life. Severe pain following TKA surgery restricts the movement of the knee joint and daily life activities, leading to the patient's inadequacy in self-care. Patients undergoing TKA surgery often face a lack of information after discharge. This lack of knowledge, coupled with uncertainty about the disease, limits the patient's self-efficacy. As the self-care power diminishes for patients struggling with daily life activities, their self-efficacy is negatively affected. The continuity of education becomes crucial since the verbal and written instructions given after surgery may not be sustained, causing a gradual decline in an individual's self-efficacy. As seen in the literature, studies have shown that postoperative pain, swelling, joint stiffness, fear, and movement limitations negatively impact the quality of life for patients undergoing TKA. Consequently, the self-care capacity, self-efficacy levels, and quality of life for individuals who have undergone TKA are adversely affected, as indicated in the literature.Ensuring continuity of care at home is crucial not only during the early postoperative period in the clinic but also after discharge. The nurse plays a significant role as an educator/advisor after discharge. The nurse provides counseling to patients discharged after Total Knee Arthroplasty (TKA) on pain management, disease progression, rehabilitation process, exercises, and considerations during daily activities (such as walking, bathing, toileting). Additionally, the nurse offers guidance on late-stage complications that may arise at home due to surgery and situations requiring hospitalization. While web-based educational interventions have been conducted for various patient groups, a web-based education program specifically for TKA surgery has not been identified. Having web-based post-TKA patient education allows continuous monitoring, assesses attendance and effectiveness remotely, and enables individuals to convey requests and questions to researchers through live support, ultimately enhancing the effectiveness of education. This approach is believed to prevent complications, reduce patient care costs and readmissions, increase patients' self-sufficiency in self-care, and consequently elevate their self-efficacy levels and quality of life. Close monitoring of postoperative patients is expected to improve their quality of life and self-care abilities, leading to increased satisfaction with healthcare services. conditions: Knee Arthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Web-based education measure: Personal Information Form measure: Self-Care Power Scale measure: Self-Efficacy - Competence Scale measure: Short Form 36 Quality of Life Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Konya City Hospital status: RECRUITING city: Konya zip: 42020 country: Turkey name: Esra Nur BOZTAŞ, MScN role: CONTACT phone: 05312958337 email: esranurboztas44@gmail.com lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06306014 id: 69HCL22_980 id: 2023-506232-32-00 type: OTHER domain: EU CT Number briefTitle: Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients acronym: LIVEDIFF overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-01-01 date: 2027-01-01 date: 2024-03-12 date: 2024-03-12 name: Hospices Civils de Lyon class: OTHER name: Exeliom Biosciences briefSummary: Clostridioides difficile infection (CDI) is the leading cause of nosocomial diarrhea in Europe, with over 120,000 cases and almost 3,700 deaths per year. This infection is characterized by a high risk of recurrence after cure, ranging from almost 20% after a first episode to over 60% after 2 recurrences, or in the case of specific risk factors.

Currently, first-line treatment of CDI is based on oral antibiotics such as fidaxomicin or vancomycin. These antibiotic treatments, which are effective in 89% and 86% of first-episode cases respectively, do not correct the microbiological imbalance underlying the onset of CDI and may, on the contrary, encourage recurrence by contributing to the maintenance of a deleterious change in the microbiota (dysbiosis) through the elimination of bacteria other than C. difficile, due to their spectrum of activity. In a number of patients, this ecological imbalance can no longer be restored after antibiotic treatment, leading to multiple recurrences of CDI.

In this context, fecal microbiota transplantation (FMT) has been validated for over 10 years for the prevention of recurrence in multi-recurrent CDI. The principle of FMT is based on the use of a pharmaceutical preparation made from the stool of a healthy donor, administered within the digestive tract of a patient for therapeutic purposes.

Currently, in the case of multiple recurrences, it is the recommended first-line treatment (from 2 recurrences) and the most effective, with a clinical efficacy preventing recurrence of CDI in 69% to 89% of cases at 8 weeks post-treatment, with a good safety profile.

Among the microbial factors promoting CDI, the loss of the bacterial species Faecalibacterium prausnitzii constitutes a specific therapeutic target. F. prausnitzii is a commensal bacterium of the human gut, making up nearly 5% of the fecal microbiota, and has been shown to be associated with an individual's state of health. A drop in its relative abundance is associated with an increased risk of numerous diseases, such as Crohn's disease and colorectal cancer. In CDI, F prausnitzii is greatly diminished. Moreover, low abundance of F. prausnitzii is predictive of C. difficile recurrence. Its abundance in stools is increased after FMT and is also predictive of response to treatment. From a pathophysiological point of view, one of the preventive effects of F. prausnitzii on recurrence would be mediated by its ability to hydrolyze the bile acids involved in the germination of C. difficile spores.

The aim of this Phase I/II trial is to assess the efficacy and safety of oral administration of EXL01, a single isolated unmodified strain of F. prausnitzii, in preventing CDI recurrence in high-risk patients at W8. The study will be conducted in 2 parts. The phase I (Part A) is planned to include 6 patients. The phase II (Part B) will include 50 patients in two arms (25 patients respectively in the placebo and EXL01 arm). conditions: Clostridioides Difficile Infection conditions: Recurrent Infection studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Part A = Single Arm open label. Part B = Randomised, placebo-controlled, double-blind. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Part A: None (Open-label). Part B: Double-blind. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 56 type: ESTIMATED name: EXL01 name: EXL01 name: Placebo measure: Incidence of Treatment-Emergent Adverse Events measure: Evaluation of the efficacy of EXL01 in preventing recurrence of C. difficile infection in patients at high risk of recurrence measure: Evaluation of the efficacy of EXL01 in preventing recurrence of C. difficile infection in patients at high risk of recurrence measure: Evaluation of the safety and tolerability profile of oral EXL01 measure: Number of stools per day over the past 24 hours measure: Stool consistency, as assessed by the Bristol scale, over the past 24 hours measure: Abdominal discomfort assessed by a validated irritable bowel syndrome scale measure: Number of stools per day over the past 24 hours measure: Stool consistency, as assessed by the Bristol scale, over the past 24 hours measure: Abdominal discomfort assessed by a validated irritable bowel syndrome scale measure: Assessment of patient quality of life during treatment and follow-up measure: Assessment of recurrence of C. difficile infection measure: Evaluation of the presence of EXL01 in the fecal microbiota measure: Assessment of EXL01 persistence in the intestinal microbiota measure: 16S rRNA sequencing or shotgun measure: 16S rRNA sequencing or shotgun measure: Assessment of the persistence of toxigenic C. difficile in the stool of patients in clinical remission during the study. measure: Assessment of the persistence of toxigenic C. difficile in the stool of patients in clinical remission during the study. measure: Assessment of recurrences of C. difficile infection requiring hospitalization measure: Assessment of recurrences of C. difficile infection requiring hospitalization measure: Assessment of recurrences of C. difficile infection requiring surgery measure: Assessment of recurrences of C. difficile infection requiring surgery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Service d'hépato-gastroentérologie - CHU Estaing city: Clermont-Ferrand zip: 63003 country: France name: Julien SCANZI, MD role: CONTACT phone: 04 73 75 02 35 email: jscanzi@chu-clermontferrand.fr name: Julien SCANZI, MD role: PRINCIPAL_INVESTIGATOR lat: 45.77966 lon: 3.08628 facility: Service d'Hépato-gastroentérologie Hôpital de la Croix Rousse city: Lyon zip: 69004 country: France name: Nicolas BENECH, MD role: CONTACT phone: 04 26 10 94 35 phoneExt: +33 email: nicolas.benech@chu-lyon.fr name: Fanny JOUBERT role: CONTACT phone: 04 26 73 27 27 phoneExt: +33 email: Fanny.joubert@chu-lyon.fr name: Nicolas BENECH, MD role: PRINCIPAL_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Service d'hépato-gastroentérologie - Hôpital Saint Antoine (APHP) city: Paris zip: 75012 country: France name: Paul MCLELLAN, MD role: CONTACT phone: 01 49 28 20 00 phoneExt: +33 email: Paul.mclellan@aphp.fr name: Paul MCLELLAN, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Service d'infectiologie - Hôpital Nord / CHU Saint Etienne city: Saint-Étienne zip: 42100 country: France name: Elisabeth BOTHELO-NEVERS, Pr role: CONTACT phone: 04 77 12 77 89 phoneExt: +33 email: elisabeth.botelho-nevers@chu-st-etienne.fr name: Elisabeth BOTHELO-NEVERS, Pr role: PRINCIPAL_INVESTIGATOR lat: 45.43389 lon: 4.39 facility: Service de médecine interne - Pôle des maladies de l'appareil digestif - CHU de Toulouse city: Toulouse zip: 31059 country: France name: Laurent ALRIC, Pr role: CONTACT phone: 05 61 32 37 54 email: Alric.l@chu-toulouse.fr name: Laurent ALRIC, Pr role: PRINCIPAL_INVESTIGATOR lat: 43.60426 lon: 1.44367 facility: Service de Maladies Infectieuses - CH de Valence city: Valence zip: 26000 country: France name: Julien SAISON, MD role: CONTACT phone: 04 75 62 57 32 phoneExt: +33 email: jsaison@ch-valence.fr name: Julien SAISON, MD role: PRINCIPAL_INVESTIGATOR lat: 44.93333 lon: 4.9 hasResults: False

 nctId: NCT06306001 id: IIRP-2023-1820/F1 briefTitle: Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-03-14 date: 2027-02 date: 2024-03-12 date: 2024-03-12 name: Post Graduate Institute of Medical Education and Research, Chandigarh class: OTHER briefSummary: Preterm infants (born at less than 37 weeks of pregnancy) sometimes develop a serious blood infection leading to low blood pressure, which does not respond to saline or to the standard medicines for increasing blood pressure, such as dopamine and epinephrine. The goal of this research study is to compare the effect of giving an injectable medicine called Methylene blue (MB) versus not giving MB to such preterm infants who are unresponsive to standard treatment. The main questions that this study aims to answer is:

1. Whether MB treatment reduces death to any cause as compared to no MB treatment.
2. Whether treatment with MB reduces the time to achieve normal blood pressure
3. Whether treatment with MB reduces the time to stoppage of all blood pressure medications, steroids and normal saline.
4. Whether treatment with MB improves heart function as measured by echocardiography at 24 and 48 hours. conditions: Neonatal Sepsis conditions: Shock, Septic studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Subjects will be randomly allocated to an intervention arm and a placebo arm. The 2 arms of the trial will run concurrently. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The random allocation will be concealed using serially numbered opaque sealed envelopes. After opening the envelope, a research nurse will administer a bolus of the study drug or placebo behind a screen, shielded from other staff. The infusion will be drawn up in an opaque syringe by the research nurse and infused through an intravenous tubing covered completely with aluminum foil. The research nurses will not be masked to the study drug. The parents of the subject, the regular staff nurses and doctors working in the unit and the project coordinator will be masked. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 130 type: ESTIMATED name: Methylene Blue name: Placebo measure: All-cause mortality within 7 days after randomization measure: Time taken to achieve therapeutic end-points within 7 days after randomization measure: Time taken to stop all inotrope/vasopressor treatment within 7 days after randomisation measure: Echocardiographic fractional shortening at 24 hour after randomization measure: Left ventricular end-diastolic diameter (LVEDD) by echocardiography at 24 hour after randomization measure: Left ventricular end-systolic diameter (LVESD) by echocardiography at 24 hour after randomization measure: Aortic diameter by echocardiography at 24 hour after randomization measure: Velocity time integral (LVI) by echocardiography at 24 hours after randomization measure: Echocardiographic fractional shortening at 48 hour after randomization measure: Left ventricular end-diastolic diameter (LVEDD) on echocardiography at 48 hour after randomization measure: Left ventricular end-systolic diameter (LVESD) by echocardiography at 48 hour after randomization measure: Aortic diameter by echocardiography at 48 hour after randomization measure: Velocity time integral (LVI) by echocardiography at 48 hours after randomization measure: Time taken to stop vasopressor treatment measure: Mortality during hospital stay measure: Serious adverse effects measure: Septic shock-related mortality sex: ALL minimumAge: 0 Days maximumAge: 28 Days stdAges: CHILD facility: Post Graduate Institute of Medical Education and Research (PGIMER) city: Chandigarh zip: 160012 country: India lat: 30.73629 lon: 76.7884 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-22 uploadDate: 2024-03-01T05:10 filename: Prot_SAP_000.pdf size: 210368 hasResults: False

 nctId: NCT06305988 id: LYG2023021 briefTitle: Neuroregulatory Effect and Mechanism of tDCS on Medial Prefrontal Cortex in ASD overallStatus: RECRUITING date: 2023-08-01 date: 2024-07-31 date: 2024-07-31 date: 2024-03-12 date: 2024-03-15 name: Jian-Jun Ou class: OTHER briefSummary: In this proposed study, a transcranial direct current stimulator is used to intervene in the medial prefrontal cortex of children with autism, and the efficacy of this intervention method is evaluated, as well as the internal mechanism of Autism Spectrum Disorders' intervention is discussed. conditions: ASD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Transcranial direct current stimulation measure: Autism assessment assessment index measure: EEG physiological detection index measure: Social Communication Changes index measure: Stereotyped behavior index measure: Sensory index measure: Abnormal behavior indicator measure: Sleep index measure: Plasma Metabolite Levels Assessment measure: Safety evaluation SAFTEE indicator sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Department of Psychiatry, Xiangya Second Hospital, Central South University status: RECRUITING city: Changsha state: Hunan zip: 410000 country: China name: Jianjun Ou, doctor role: CONTACT phone: 17775861486 email: oujianjun@csu.edu.cn lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06305975 id: STUDY00003169 briefTitle: Blunt Fascial vs. Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery acronym: BluntFascial overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03-01 date: 2025-03-01 date: 2024-03-12 date: 2024-03-12 name: Cedars-Sinai Medical Center class: OTHER briefSummary: This study aims to investigate the effect of two peritoneal entry techniques on intraoperative and post-operative outcomes among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon. Patients will be randomized to either blunt fascial or veress needle peritoneal entry. Insufflation times, failed entries, complications and post-operative pain scores will be collected.

The investigators hypothesize that the blunt entry technique will be associated with shorter insufflation times and similar intraoperative and postoperative outcomes compared with the veress needle entry technique.

Primary Objective: To evaluate the insufflation times and success upon peritoneal entry according to peritoneal entry technique.

Secondary Objectives: To evaluate the surgical outcomes and patients pain scores according to peritoneal entry technique. conditions: Laparoscopic Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Blunt fascial abdominal entry name: Veress needle abdominal entry measure: Insufflation time measure: Success upon peritoneal entry measure: Intraoperative complications measure: Postoperative complications measure: Patients pain scores measure: Analgesics use measure: Length of hospital stay sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06305962 id: 177Lu-RAD204.2023.0001 briefTitle: 177Lu-anti-PD-L1 sdAb in Metastatic Non-small Cell Lung Cancer overallStatus: RECRUITING date: 2024-03 date: 2025-07 date: 2025-10 date: 2024-03-12 date: 2024-03-26 name: Radiopharm Theranostics, Ltd class: INDUSTRY briefSummary: This is a first-in-human, open-label study consisting of a Screening Period, an Imaging Period, and a Treatment Period in eligible non-small lung cancer patients who are positive for the biomarker PDL-1. The Screening period lasts up to 4 weeks. The Phase 0 (Imaging Period) is used to determine if patient's tumor(s) are still positive for the biomarker, as well as radiation dosimetry with low dose 177Lu-RAD204im (for a period of up to 2 weeks following the first injection of 177Lu-RAD204im), to assess the safety of the drug. Following the 2 week safety assessment, the subject is eligible to enter Phase I (Treatment Period) with gradual dose increases of 177Lu-RAD204tr. The Treatment Period lasts up to 3 cycles every 6 weeks, with additional extension to a maximum study dose interval of 12 weeks to be approved on a case-by-case basis in discussion with study Sponsor. During the Treatment Period, subjects will be assessed for both safety and treatment response using conventional images and clinical laboratory tests. conditions: PDL1 Gene Mutation conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 23 type: ESTIMATED name: 177Lu-RAD204 measure: Time Activity Curves (TACs) measure: Radiation dosimetry of Lu177-RAD204im measure: Pharmacokinetics of 177Lu-RAD204im measure: Biokinetics of 177Lu-RAD204im measure: Safety and tolerability of 177Lu-RAD204tr measure: Recommended dose(s) of 177Lu-RAD204tr for future exploration measure: Safety and tolerability of a single dose of 177Lu-RAD204im measure: Recommended dose(s) of 177Lu-RAD204im for future exploration measure: Preliminary antitumor activity of 177Lu-RAD204tr measure: Radiation dosimetry of 177Lu-RAD204tr measure: Level of agreement between 177Lu-RAD204im and standard of care imaging measure: Effect of 177Lu-RAD204im and 177Lu-RAD204tr on tumor markers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Princess Alexandra Hospital status: RECRUITING city: Woolloongabba state: Queensland zip: 4102 country: Australia name: Kenneth O'Byrne, MD role: CONTACT phone: +610449091958 email: kenneth.obyrne@health.qld.gov.au lat: -27.48855 lon: 153.03655 facility: Hollywood Private Hospital status: RECRUITING city: Nedlands state: Western Australia zip: 6009 country: Australia name: Joe Cardaci, MD role: CONTACT phone: 0893862844 email: jcardaci@dni.com.au lat: -31.98184 lon: 115.8073 hasResults: False

 nctId: NCT06305949 id: XC23DDDS0098 briefTitle: Clinical Trial on the Safety and Efficacy of Optimized Transcranial Direct Current Stimulation for the Swallowing Function in Patients With Post-Stroke Dysphagia overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-07-31 date: 2025-12-31 date: 2024-03-12 date: 2024-03-12 name: NEUROPHET class: INDUSTRY name: Bucheon St. Mary's Hospital name: Saint Vincent's Hospital, Korea name: National Traffic Injury Rehabilitation Hospital name: Pusan National University Yangsan Hospital briefSummary: The goal of this clinical trial is to evaluate whether the application of optimized transcranial direct current stimulation is more effective compared to sham stimulation for temporary improvement of swallowing function in patients with post-stroke dysphagia. conditions: Deglutition Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Personalized transcranial Direct Current Stimulation measure: Functional Oral Intake Scale (FOIS) measure: Penetration-aspiration Scale (PAS) measure: Functional Oral Intake Scale (FOIS) measure: Penetration-aspiration Scale (PAS) measure: Videofluoroscopic Dysphagia Scale (VDS) measure: Korean Mann Assessment of Swallowing Ability (K-MASA) measure: Speech Mechanism Screening Test (SMST) measure: Urimal Test of Articulation and Phonology (U-TAP) measure: modified Rankin Scale (mRS) measure: Gugging Swallowing Screen measure: Eating Assessment Tool-10 (EAT-10) measure: Iowa Oral Performance Instrument (IOPI) measure: Motor-Evoked Potential (MEP) measure: Grade, Roughness, Breathiness, Asthenia and Strain scale(GRBAS scale) measure: Respiratory muscle strength measure: Peak cough flow sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06305936 id: PLATE H-23042292 briefTitle: Feasibility Study: Plant Based Diet to Patients With Rheumatoid Arthritis acronym: PLATE overallStatus: RECRUITING date: 2024-02-15 date: 2024-07-31 date: 2024-12-31 date: 2024-03-12 date: 2024-03-15 name: Bispebjerg Hospital class: OTHER name: Glostrup University Hospital, Copenhagen briefSummary: In this feasibility study, our primary goal is to assess the practicality of implementing a plant-based food diet intervention for individuals with rheumatoid arthritis (RA). The intervention consists of three key components: 1) Educational materials (videos), 2) Participation in a cooking workshop introducing plant-based meals, complete with recipes, and 3) Daily delivery of plant-based dinner meals over a four-week period. This comprehensive investigation covers the testing of recruitment procedures, randomization, intervention elements, outcome assessments, and participant retention.

Adopting a daily plant-based diet involves introducing several new plant-based foods and making adjustments to the existing diets of patients with RA. Consequently, the feasibility study will also aim to explore the acceptability of the intervention and whether a full-scale RCT is practically possible. conditions: Rheumatoid Arthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised feasibility study of an intervention group, receiving 100% plant-based diet and a control group primaryPurpose: OTHER masking: DOUBLE maskingDescription: Not possible to blind participants and study staff delivering the intervention to allocation status, whereas all outcome data is planned to be collected by blinded outcome assessors. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Intervention with 100% plant-based diet measure: Evaluation of Feasibility and Intervention Fidelity in Implementing a Plant-Based Food Diet Intervention - Evaluating the feasibilty of included objectively measured outcomes and self-administered questionnaires measure: Evaluation of Study Acceptance measure: Recruitment measure: Retention measure: Intervention adherence measure: Disease Activity Score (DAS28) measure: Fatigue: Bristol Rheumatoid Arthritis Fatigue (BRAF MDQ) measure: Pain (VAS) measure: Sleep measure: Anxiety/depression measure: Physical function measure: Impact of rheumatoid arthritis (RA) measure: The EuroQuality of Life (EQ-5D) measure: Height measure: Weight measure: Waist- and hip circumference measure: Disease activity measure: Body composition measure: Quantification of tender and swollen joints measure: C-reactive Protein (CRP) measure: Hemoglobin measure: Leukocytes measure: Thrombocytes measure: Hemoglobin (HbA1c) measure: D-vitamin measure: Low-density lipoprotein (LDL) measure: High-density lipoprotein (HDL) measure: Triglyceride measure: Total cholesterol sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Clinical Research and Prevention, BispebjergH status: ACTIVE_NOT_RECRUITING city: Frederiksberg zip: DK 2000 country: Denmark lat: 55.67938 lon: 12.53463 facility: The Department of Rheumatology and Spine Diseases, Copenhagen Center for Arthritis Research (COPECARE), Rigshospitalet, Glostrup status: RECRUITING city: Glostrup zip: 2600 country: Denmark name: Tanja Thomsen, Ph.D. role: CONTACT phone: +4538163107 email: tanja.thomsen@regionh.dkdkTanja.thomsen@regionh.dk name: Kamille Torp, Ph.D. role: CONTACT phone: +4538163113 email: kamille.almer.bernsdorf.torp@regionh.dk name: Bente Appel Esbensen, Ph.D. role: SUB_INVESTIGATOR lat: 55.6666 lon: 12.40377 hasResults: False

 nctId: NCT06305923 id: RNN/275/21/KE id: 503/3-066-02/503-31-001 type: OTHER_GRANT domain: Medical University of Lodz briefTitle: The Efficacy of a Cosmetic Preparation Containing Sheep Colostrum on Mature Skin acronym: COLMATSKIN overallStatus: COMPLETED date: 2022-03-01 date: 2022-06-30 date: 2022-07-31 date: 2024-03-12 date: 2024-03-12 name: Medical University of Lodz class: OTHER briefSummary: The goal of this clinical trial is to learn about colostrum as a cosmetic in mature skin. . The aim of the study was to examine the effect of a cosmetic preparation containing sheep colostrum on skin with signs of aging in mature women Participants will be given the creams and asked to apply one -two doses in the evening after nighttime facial cleaning. They were also asked to use sunscreens during the day. During the first visit and after eight weeks of everyday use of the tested cream, the skin parameters will be measured three times on both cheeks, and the results were averaged.

Participants will be enrolled to the colostrum cream or base cream groups and will not be informed which group they belonged to. conditions: Skin Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 52 type: ACTUAL name: colostrum cream name: placebo cream measure: hydration measure: transepidermal water loss measure: erythema and melanin content measure: sebum measure: firmness of the skin measure: firmness of the skin sex: FEMALE minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Lodz city: Lodz zip: 90-419 country: Poland lat: 51.75 lon: 19.46667 hasResults: False

 nctId: NCT06305910 id: CMN-DMGVac-01 briefTitle: CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMG/DIPG in Children and Young Adults overallStatus: RECRUITING date: 2024-03-15 date: 2025-09-15 date: 2027-01-15 date: 2024-03-12 date: 2024-03-12 name: OX2 Therapeutics class: INDUSTRY briefSummary: This is a single center Phase I study of a new adjuvant CD200 activation receptor ligand, CD200AR-L, in combination with imiquimod and GBM6-AD vaccine to treat malignant glioma in children and young adults.

The primary objective of this study is to determine the maximum tolerated dose (MTD) of CD200AR-L when given with a fixed dose of GBM6-AD vaccine, imiquimod, and a single dose of radiation for patients with recurrent High Grade Glioma (HGG) or following standard of care therapy radiation therapy for newly diagnosed Newly Diagnosed Diffuse Midline Glioma/Diffuse Intrinsic Pontine Glioma (DIPG/DMG). conditions: Diffuse Midline Glioma, H3 K27M-Mutant conditions: Recurrent High Grade Glioma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: 3+3 design primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Treatment with CD200AR-L measure: Maximum Tolerated Dose (MTD) of CD200AR-L measure: Incidence of serious adverse events (SAEs) measure: Time to progression (TTP) by 24 months measure: Progression free survival (PFS) by 24 months measure: Overall survival (OS) by 24 months sex: ALL minimumAge: 2 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Children's Minnesota status: RECRUITING city: Minneapolis state: Minnesota zip: 55404 country: United States name: Anne Bendel, MD role: CONTACT phone: 612-813-5940 email: anne.bendel@childrensmn.org lat: 44.97997 lon: -93.26384 hasResults: False

 nctId: NCT06305897 id: CS5_10B briefTitle: Evaluation of the Tolerance (Main Objective) and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post-inflammatory Hyperpigmentation) on the Face acronym: CS5_10B overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-03-12 date: 2024-04-17 name: Cryonove Pharma class: INDUSTRY briefSummary: The goal of this clinical trial is to compare the 3 different prototype of cyto-selective cryotherapy devices (name of the devices : CRYONOVE) use in brown spots on the face of subject from different ethnicities. The main questions it aims to answer are:

* the tolerance of 3 prototypes of cyto-selective cryotherapy treatments
* the performance of 3 prototypes of cyto-selective cryotherapy treatments

Participants will be treated for each spots with a definied prototype during 6 treatment visits.

Researchers will compare the tolerance and performance of the 3 prototypes. conditions: Lentigo conditions: Solar Lentigo conditions: Post Inflammatory Hyperpigmentation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Proof of concept study concerning 3 prototypes of cyto-selective cryotherapy devices corresponding to a modified CE marked medical device (ref: 822-v1). primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 45 type: ESTIMATED name: CRYONOVE (EC14_4osc) name: CRYONOVE (EC+05_1osc) name: CRYONOVE (EC+05_2osc) measure: Tolerance measure: Performance sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06305884 id: OSU-21287 id: NCI-2023-03077 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) briefTitle: Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-12 date: 2024-03-12 name: Ohio State University Comprehensive Cancer Center class: OTHER briefSummary: This clinical trial studies how well new adhesive-based sensors that stick to the skin (transcutaneous) work in detecting cancer-related long-term arm swelling (lymphedema). For many patients, lymphedema s painful, unsightly, and weakening. The early signs of lymphedema are hard to see, and sometimes it is only diagnosed by hospital equipment at larger centers. Treating lymphedema early is usually more successful than trying to treat in later stages. The adhesive-based sensors used in this study work by using techniques called photoplethysmography (PPG) and bioimpedance (BI). PPG is an optical technique that can be used to detect blood volume changes in tissue. BI evaluates how tissue responds to an externally applied electrical current. This study may assist researchers in distinguishing participants with lymphedema in comparison to participants without lymphedema, and develop a way for patients to check for lymphedema at home. conditions: Hematopoietic and Lymphoid System Neoplasm conditions: Lymphedema conditions: Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 70 type: ESTIMATED name: Bioelectric Impedance Analysis name: Exercise name: Photoplethysmography name: Questionnaire Administration measure: Unique signature describing photoplethysmography and bioimpedance at rest and during activity measure: Patient reported outcomes measure: Tolerability of sensors measure: Likely classification for lymphedema sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio State University Comprehensive Cancer Center city: Columbus state: Ohio zip: 43210 country: United States name: Carlo M. Contreras, MD role: CONTACT phone: 614-293-3465 email: Carlo.Contreras@osumc.edu name: Carlo M. Contreras, MD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06305871 id: 2023-NHLHCRF-YYPPLC-ZR-09 briefTitle: Clinical Study of Ultrasound-guided Radiofrequency Ablation in the Treatment of Refractory Hyperthyroidism overallStatus: ACTIVE_NOT_RECRUITING date: 2023-08-01 date: 2025-07-31 date: 2025-07-31 date: 2024-03-12 date: 2024-03-12 name: Zhang Bo class: OTHER briefSummary: Hyperthyroidism is an endocrine disease with a high incidence rate, and some patients are difficult to effectively control the condition after long-term drug treatment, and the disease recurs, forming refractory hyperthyroidism. The search for a new safe, effective and minimally invasive treatment has become a research hotspot. Ultrasound-guided radiofrequency ablation is a hot spot in clinical research due to its advantages of low trauma, high safety, precise inactivation of lesions, and multiple ablation. However, there is no unified standard for the number and scope of ablation in the treatment of refractory hyperthyroidism by radiofrequency ablation, and there is a lack of data on the effectiveness and safety of the treatment with large samples and long-term effects. Therefore, how to establish a standardized treatment strategy and appropriate plan for ablation of refractory hyperthyroidism based on clinical practice is an urgent problem to be solved. The purpose of this study was to prospectively include refractory hyperthyroidism for ultrasound-guided radiofrequency ablation, and to evaluate the efficacy and safety of hyperthyroidism ablation by comparing the changes in symptoms and signs, serology, and imaging of patients before and after ablation. The relevant factors affecting the efficacy of ablation were analyzed and the most appropriate ablation scope was determined. Radiofrequency ablation was retrospectively compared with traditional surgery and 131I treatment, and the near- and medium-term treatment effects, incidence of adverse reactions and complications, as well as the economic benefits and sociopsychological differences of the three treatment methods were compared.

The expected outcome of this study is to establish a research cohort of hyperthyroidism ablation based on a large sample population, and to establish the most appropriate and effective regimen for radiofrequency ablation of refractory hyperthyroidism compared with traditional surgery and 131I treatment with safety and near- and medium-term efficacy. The Department of Ultrasound Medicine of China-Japan Friendship Hospital has accumulated rich experience in the ablation treatment of benign and malignant thyroid nodules and hyperthyroidism, and has completed more than 200 cases of thyroid ablation in the past two years. Under the leadership of Professor Zhang Bo, the research team of this project has conducted a number of clinical studies on the ultrasound diagnosis and treatment of thyroid diseases, presided over and participated in more than 20 national, provincial and university-level scientific research courses, and the first author or corresponding author wrote more than 70 articles in related fields, which laid a solid research foundation for the conduct of this study. conditions: Hyperthyroidism/Thyrotoxicosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Ablation therapy measure: Discontinuation rate measure: Recurrence rate sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China-Japan friendship hospital city: Beijing state: Beijing zip: 100000 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06305858 id: UKA - PFJ briefTitle: Partial Versus Total Knee Replacement in Bicompartmental Gonarthrosis (Medial and Patellofemoral): Prospective Functional Assessment Study overallStatus: RECRUITING date: 2022-03-01 date: 2025-09 date: 2025-12 date: 2024-03-12 date: 2024-03-12 name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio class: OTHER briefSummary: The study is, in accordance with current legislation, definable as a prospective single-center interventional randomized study.

The aim of the study is to evaluate the post-operative recovery of the group A patient undergoing the partial knee replacement surgical procedure compared to the group B patient undergoing the total knee replacement surgical procedure through clinical/functional scores.

The primary outcome is evaluate the difference in score of the KSS questionnaire, at 1 month after surgery, completed by the patient of group A compared to the patient of group B.

The population consists of 48 adult patients with gonarthrosis divided into two groups:

24 patients Group A experimental group: partial denture surgical procedure

24 patients Group B control group: total denture surgical procedure with patellar resurfacing conditions: Knee Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 48 type: ESTIMATED name: Prosthetic Surgical Procedure measure: Assess the difference in score of the KSS (Knee Society Score) questionnaire, completed by the patient in group A compared to the patient in group B sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Clinico San Siro status: RECRUITING city: Milan country: Italy name: Elena Cittera role: CONTACT phone: 0283502224 email: elena.cittera@grupposandonato.it name: Andrea Parente role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06305845 id: 152012023 briefTitle: Digital Crowns Versus Prefabricated Crowns on Primary Teeth overallStatus: ACTIVE_NOT_RECRUITING date: 2023-06-01 date: 2023-09-20 date: 2024-09 date: 2024-03-12 date: 2024-03-12 name: National Research Centre, Egypt class: OTHER briefSummary: Badly decayed primary molars will be treated by performing the pulp therapy technique indicated, then the patients will be randomized into two groups to receive the restorative intervention. For the intervention group, teeth will be prepared to receive the digital crown after intraoral scanning while for the control group, teeth will be prepared to receive the prefabricated zirconia crowns. Teeth will be followed up clinically for 1 year, at 1, 6 and 12 months. conditions: Dental Caries in Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a randomized clinical trial with two parallel arms primaryPurpose: TREATMENT masking: SINGLE maskingDescription: participants will not be informed of which crown they will receive whoMasked: PARTICIPANT count: 58 type: ESTIMATED name: Digital crowns measure: Patient and parent satisfaction measure: Crown retention measure: Gingival inflammation measure: Color match sex: ALL minimumAge: 4 Years maximumAge: 10 Years stdAges: CHILD facility: National Research Centre city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06305832 id: IUNU-PC-120 briefTitle: Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer overallStatus: RECRUITING date: 2023-09-07 date: 2028-03 date: 2028-03 date: 2024-03-12 date: 2024-03-12 name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School class: OTHER briefSummary: To evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy(ADT) and standard salvage radiation therapy(SRT) or SRT combination with ADT in prostate cancer patients with biochemical recurrence of prostate-specific antigen(PSA) persistence after radical prostatectomy(RP). conditions: Prostate Cancer conditions: Biochemical Recurrence studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 102 type: ESTIMATED name: Rezvilutamide name: Androgen deprivation therapy (ADT) name: SRT measure: 3-year biochemical progression-free survival measure: progression-free survival (PFS) measure: metastasis-free survival (MFS) measure: percentage of undetectable PSA measure: ctDNA-positive rate measure: ctDNA clearance rate measure: Adverse Events sex: MALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University status: RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Shun Zhang role: CONTACT phone: 15050589789 phoneExt: 15050589789 email: explorershun@126.com lat: 32.06167 lon: 118.77778 facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School status: RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Hongqian Guo, Phd role: CONTACT phone: 13605171690 email: dr.ghq@nju.edu.cn name: Shun Zhang role: CONTACT name: Hongqian Guo role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06305819 id: 2023057 briefTitle: Effectiveness of a Self-management Program After Traumatic Injury acronym: SEMPO overallStatus: RECRUITING date: 2024-01-01 date: 2030-12-31 date: 2030-12-31 date: 2024-03-12 date: 2024-04-12 name: Oslo University Hospital class: OTHER name: South-Eastern Norway Regional Health Authority name: Sunnaas Rehabilitation Hospital name: University of Oslo briefSummary: Traumatic injuries, defined as a physical injury with sudden onset, are a leading cause to disability and impaired health. Persons who sustain a traumatic injury often report problems in daily life activities and reduced quality of life, which may limit participation in work/studies, leisure activities and family life. Consequently, complex rehabilitation and support is recommended in National Trauma guidelines due to the often long-lasting physical and psychological sequela of the injury.

The main goal of this study is to determine the effectiveness of a self-management support program delivered to persons with a moderate or severe traumatic injury in the sub-acute phase of recovery (i.e. 3-4 months after injury). The self-management program aims to enhance patients' self-efficacy by building skills and self-management strategies to cope with injury-related consequences. The program has a group-based format and consists of eight sessions comprising psychoeducation, skill mastery and sharing of experiences. The participants who will be included in the study must be between 18 and 70 years, be residing in the southeast region of Norway, be admitted to Oslo University hospital or transferred from local hospital within 72 hours after injury, have at least a two-day hospital stay, and be able to read and understand Norwegian language. Participants will be randomly assigned to either intervention or control group. A group of patients will also be able to self-select if they want to receive the self-management support program or be in the control group. The latter is an explorative part of the study to evaluate the influence of patients' treatment-preferences on the study outcomes. Participants in the control group will receive treatment as usual. conditions: Trauma Injury conditions: Trauma, Multiple conditions: Polytrauma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 220 type: ESTIMATED name: self-management support program name: Control group measure: Trauma Coping Self-Efficacy measure: Rivermead Post-Concussion Symptom Questionnaire measure: Fatigue Severity Scale measure: Insomnia Severity Index measure: Brief Pain Inventory -short form measure: International Physical Activity Questionnaire measure: Cognitive Failures Questionnaire measure: Patient Health Questionnaire-9 measure: Generalised Anxiety Disorder-7 measure: Impact of Event Scale - Revised measure: Return to work measure: Resilience Scale for Adults measure: EuroQol five-dimensional questionnaire measure: Target Outcomes measure: Patient Global Impression of Change measure: Intervention acceptability and satisfaction measure: Intervention satisfaction measure: WHO Disability Assessment Scale measure: Glasgow Outcome Scale - Extended measure: Communication with physicians measure: Health Literacy Questionnaire measure: Received health care services sex: ALL minimumAge: 18 Years maximumAge: 72 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oslo University Hospital status: RECRUITING city: Oslo country: Norway name: Mari Storli Rasmussen, PhD role: CONTACT phone: +4799797575 email: masras@ous-hf.no name: Solveig L. Hauger, PhD role: CONTACT phone: +4791310358 email: solveig.hauger@gmail.com lat: 59.91273 lon: 10.74609 hasResults: False

 nctId: NCT06305806 id: Pro00112597_B id: OTA-21-015G type: OTHER domain: NIH Grant to RTI; RTI subcontracting with DCRI briefTitle: RECOVER-AUTONOMIC: Platform Protocol, Appendix B (Ivabradine) overallStatus: ENROLLING_BY_INVITATION date: 2024-03-11 date: 2025-12 date: 2026-03 date: 2024-03-12 date: 2024-04-09 name: Kanecia Obie Zimmerman class: OTHER briefSummary: This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.

This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs. conditions: Long COVID conditions: Long Covid19 conditions: Long Covid-19 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In each Appendix trial, each participant will be assigned with equal probability to one of the factorial combinations based on two factors: (1) a study intervention/control and (2) non-pharmacologic intervention/control if the participant is eligible for the study intervention. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Double blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 180 type: ESTIMATED name: Ivabradine name: Ivabradine Placebo name: Coordinated Care name: Usual Care measure: Change in Orthostatic Hypotension Questionnaire (OHQ)/Orthostatic Intolerance Questionnaire (OIQ) Composite Score measure: Change in Composite Autonomic Symptoms Score 31 (COMPASS-31) measure: Change in Malmo POTS Symptom Score measure: Change in Active Stand Test measure: Change in blood pressure (BP) measure: Change in heart rate (HR) measure: Change in 6-min Walk Test measure: Change in PROMIS-29 + 2 Questionnaire measure: Change in step count as measured by a wearable device measure: Change in heart rate as measured by a wearable device measure: Proportion of participants who experience individual SAEs measure: Proportion who experience any one or more SAEs measure: Incidence of SAEs leading to discontinuation measure: Incidence of Events of Special Interest (ESIs) measure: Changes in Autonomic Function Testing measure: Change in Vanderbilt Orthostatic Symptoms Score (VOSS) measure: Change in PASC Symptom Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: All sites listed under NCT06305780 city: Durham state: North Carolina zip: 27710 country: United States lat: 35.99403 lon: -78.89862 hasResults: False

 nctId: NCT06305793 id: Pro00112597_A id: OTA-21-015G type: OTHER domain: NIH Grant to RTI; RTI subcontracting with DCRI briefTitle: RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG) overallStatus: ENROLLING_BY_INVITATION date: 2024-03-11 date: 2025-12 date: 2026-03 date: 2024-03-12 date: 2024-04-08 name: Kanecia Obie Zimmerman class: OTHER briefSummary: This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.