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* If ultrasound is just as accurate as fluoroscopy to assess the GT position.
* If ultrasound takes less time than fluoroscopy to assessing the GT position.
Participants will be imaging using ultrasound to assess GT positioning before their standard of care fluoroscopic imaging. conditions: Gastrostomy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 10 type: ESTIMATED name: Ultrasound Imaging measure: Proportion of Ultrasound that Agree with Fluoroscopy with Respect to Identifying the GT Location measure: Sensitivity of ultrasound (US) to determine the visualization of GT leakage measure: Specificity of ultrasound (US) to determine the visualization of GT leakage measure: Duration of ultrasound (US) to complete evaluation of GT position sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: University of North Carolina at Chapel Hill city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Hannah P Mignosa-Martin role: CONTACT phone: 919-843-1670 email: [email protected] name: Desma Jones role: CONTACT phone: 9198439463 email: [email protected] name: William Pryor, MD role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False
<|newrecord|> nctId: NCT06361485 id: 011624 briefTitle: Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain overallStatus: RECRUITING date: 2024-03-25 date: 2027-03-31 date: 2028-04-01 date: 2024-04-11 date: 2024-04-11 name: R3 Stem Cell class: INDUSTRY name: R3 Medical Research briefSummary: This is a Pilot Study that is an open label, prospective, non-controlled study in which the safety and feasibility of Wharton's Jelly (WJ) allograft will be evaluated in 100 participants suffering with low back pain. conditions: Low Back Pain studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, open label, non-controlled Pilot study primaryPurpose: TREATMENT masking: NONE maskingDescription: Open Label count: 100 type: ESTIMATED name: Lumbar Injections with 10cc's of Wharton's Jelly Allograft measure: C-reactive protein measure: Erythrocyte sedimentation rate measure: Alanine transaminase (ALT) measure: Aspartate transaminase (AST) measure: Alkaline phosphatase (ALP) measure: Albumin measure: Creatinine measure: Blood Urea Nitrogen (BUN) measure: 36-Item Short Form Survey (SF-36) measure: Numerical Pain Rating Scale (NPRS) measure: Oswestry disability index (ODI) measure: Roland Morris disability questionnaire (RMQ) measure: The Patient-specific functional scale (PSFS) sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: R3 Anti Aging Scottsdale status: RECRUITING city: Scottsdale state: Arizona zip: 85262 country: United States name: David Greene, MD, PhD, MBA role: CONTACT phone: 480-306-6256 email: [email protected] name: Sabrina Solt, NMD role: PRINCIPAL_INVESTIGATOR lat: 33.50921 lon: -111.89903 facility: R3 Anti Aging Beverly Hills status: RECRUITING city: Beverly Hills state: California zip: 90210 country: United States name: Kathleen Francesca, BA role: CONTACT phone: 424-382-1074 email: [email protected] name: Neville Campbell, MD role: PRINCIPAL_INVESTIGATOR lat: 34.07362 lon: -118.40036 facility: Scheer Medical Wellness status: RECRUITING city: New York state: New York zip: 10036 country: United States name: Alexandre Scheer, MD role: CONTACT phone: 646-762-9499 email: [email protected] name: Alexandre Scheer, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Dr. Duc (Steve) Le, MD status: RECRUITING city: Cleveland state: Texas zip: 77327 country: United States name: Steve Le, MD role: CONTACT phone: 281-593-1500 email: [email protected] name: Steve Le, MD role: PRINCIPAL_INVESTIGATOR lat: 31.67682 lon: -99.25367 hasResults: False
<|newrecord|> nctId: NCT06361472 id: 11695 briefTitle: Contextual Factors-Enriched Standard Care on Mechanical Neck Pain overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-08-31 date: 2025-11-30 date: 2024-04-11 date: 2024-04-15 name: Universidad Nacional de la Matanza class: OTHER briefSummary: The primary purpose of this study will be to determine if a CFs-Enriched Standard Care approach is an effective treatment for mechanical neck pain in terms of reducing pain and improving function. We hypothesize that a 4-week CFs-Enriched Standard Care approach will be superior to Standard Care alone in terms of patient-reported disability and pain, with measurements conducted using the Northwick Park Neck Pain Questionnaire and the Numeric Pain Rating Scale, respectively.
This will be an assessor-blinded, 2-group (1:1) randomized clinical trial aiming to enroll 94 participants with neck pain persisting for more than 4 weeks. Both groups will undergo 4 weeks of standard care twice weekly, following established clinical practice guidelines. In the intervention group, CFs will be enhanced, encompassing the physical, psychological, and social elements inherent in the clinical encounter, based on existing evidence.
The primary outcomes will encompass changes in Pain and Disability after 4 weeks of treatment, with a follow-up reassessment at week 12 post-treatment. Secondary outcomes will include changes in Active Range of Motion, Global Rating of Change, and Satisfaction with treatment. The change between groups after treatment and at the 12-week follow-up will be reported for all outcomes, considering the difference from scores recorded at baseline. conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The ContextualizAR trial is designed as a two-arm, randomized, controlled, and blinded assessor superiority trial conducted at a single center. Patients will be allocated to one of two groups: a CFs+SC group and the SC group. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Due to the nature of the study, blinding of both therapists and patients will not be feasible. However, to uphold the scientific validity of the study, specific descriptors and methodological details, such as terms like "placebo" or "CFs," have been intentionally excluded from the consent disclosure. To prevent any potential bias in participants' perceptions, information regarding the potential involvement of CFs in outcomes will not be provided. Instead, participants will be informed that the study aims to assess changes resulting from standard treatment for MNP. The person in charge of data statistical analysis (FV) and the evaluators who will assess all participants' pre- and post-intervention assessments (MLL and AR) will be blinded to the allocated intervention. whoMasked: OUTCOMES_ASSESSOR count: 94 type: ESTIMATED name: Standard Care name: Contextual Factors measure: Neck Pain Intensity measure: Neck Disability measure: Active Range of Movement measure: Global Rating of Change measure: Satisfaction with treatment measure: Expectations measure: Credibility sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06361459 id: NL83858.058.12 briefTitle: Stop Smoking in Spine Surgery overallStatus: RECRUITING date: 2023-07-06 date: 2026-06-30 date: 2026-12-31 date: 2024-04-11 date: 2024-04-11 name: Leiden University Medical Center class: OTHER name: Medical Center Haaglanden name: Haga Hospital name: Alrijne Hospital name: Spaarne Gasthuis briefSummary: Patients that are subjected to a medium complex surgical intervention in neck (posterior) or lumbar spine (posterior) with instrumentation are motivated to stop smoking. The outcome data of patients that stop and that continue smoking will be compared. A group of non smokers is evaluated as a control group. Particularly clinical outcome is evaluated, as well as radiological outcome. conditions: Smoking Cessation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: three study groups: group that does not smoke, group that smokes and stops, group that smokes and does not stop primaryPurpose: TREATMENT masking: NONE count: 210 type: ESTIMATED name: Stop smoking measure: ODI or NDI measure: VAS leg or arm pain measure: HADS measure: EuroQol measure: perceived recovery measure: radiological evaluation for fusion sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Leiden University Medical Centre status: RECRUITING city: Leiden state: Zuid Holland zip: 2300RC country: Netherlands name: carmen vleggeert-lankamp, MD MSc PhD role: CONTACT phone: +31630925428 email: [email protected] lat: 52.15833 lon: 4.49306 hasResults: False
<|newrecord|> nctId: NCT06361446 id: 023098816 briefTitle: Zonisamide Versus Propranolol in Migraine overallStatus: RECRUITING date: 2024-03-29 date: 2025-03-30 date: 2025-04-20 date: 2024-04-11 date: 2024-04-23 name: Kafrelsheikh University class: OTHER briefSummary: Investigators aim to compare the effect of zonisamide versus propranolol in migraine by assessing the absolute reduction in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency conditions: Migraine studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: We will assess The number of migraine days after three months of treatment, and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: An independent statistician generated a blocked randomization sequence using computer-generated random numbers; participants received either zonisamide and acetaminophen or propranolol and acetaminophen from a specially trained and qualified nurse. We prepared Sequentially numbered opaque sealed envelopes and 600 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 600. Envelopes were attached to the patient's files. Patients were recruited sequentially and were given enrollment numbers starting from 1, which were mentioned in their files. Files with the same number as the patient enrolment number were opened and the patients were assigned to receive drugs A or B. Drug A included zonisamide and acetaminophen, and Drug B included propranolol and acetaminophen. The statistical analysis was performed by an independent statistician who did not know the treatment protocol of groups A or B. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: Zonisamide 50 MG name: Propranolol measure: The change in migraine days per 28 days measure: The total number of migraine days after three months of treatment measure: The percentage of patients who achieved ≥ 50% reduction in the monthly migraine days frequency compared to the baseline frequency. measure: HIT-6 score absolute change in each group after three months of treatment measure: The safety of lacosamide was evaluated by monitoring treatment-emergent adverse events (TEAE) for three months. sex: ALL minimumAge: 10 Years maximumAge: 55 Years stdAges: CHILD stdAges: ADULT facility: Kafr Elsheikh University Hospital status: RECRUITING city: Kafr Ash Shaykh zip: 33511 country: Egypt name: mohamed G. Zeinhom, MD role: CONTACT phone: 2001009606828 email: [email protected] lat: 31.11174 lon: 30.93991 hasResults: False
<|newrecord|> nctId: NCT06361433 id: R5-11 briefTitle: Intracerebral Transplantation of Autologous MSC Combined With Scaffold Product for Chronic Intracerebral Hemorrhage acronym: RAINBOW-Hx overallStatus: RECRUITING date: 2023-12-01 date: 2026-02 date: 2026-02 date: 2024-04-11 date: 2024-04-11 name: Hokkaido University Hospital class: OTHER name: Japan Agency for Medical Research and Development briefSummary: The goal of this clinical trial is to test intracerebral transplantation of stem cell product in patient with chronic intracerebral hemorrhage. The main questions aims to answer are:
* The safety of the product
* The efficacy of the product conditions: Intracerebral Hemorrhage studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: HUFF-01 measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 measure: Change in mRS examination measure: Change in NIHSS examination measure: Change in FIM examination measure: Change in Fugl-Myer examination measure: Change in Barthal index examination measure: Change in FDG-PET examination measure: Change in IMZ-SPECT examination sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hokkaido University Hospital status: RECRUITING city: Sapporo state: Hokkaido zip: 0608638 country: Japan name: Masahito Kawabori role: CONTACT phone: +81117065987 email: [email protected] lat: 43.06667 lon: 141.35 hasResults: False
<|newrecord|> nctId: NCT06361420 id: 2023YF051-01 briefTitle: Driving Pressure-guided Lung Protective Ventilation acronym: DPV overallStatus: RECRUITING date: 2024-01-26 date: 2024-12-30 date: 2025-03-31 date: 2024-04-11 date: 2024-04-11 name: Yong Lin, PhD class: OTHER briefSummary: The study, named as "The Efficacy of Driving Pressure-guided Lung Protective Ventilation in Surgical Repair of Acute Type A Aortic Dissection: an open-label, randomized control clinical trial", aims to investigate whether driving pressure-guided lung protective ventilation can reduce postoperative oxygenation function in patients who have undergone surgical repair of acute type A aortic dissection. The primary outcomes is the incidence of postoperative hypoxemia (a partial pressure of arterial oxygen to inspiratory oxygen fraction ratio less than 300 mm Hg or a peripheral blood oxygen saturation less than 93% at any concentration of inspiratory oxygen) within 7 days after the surgery. conditions: Hypoxemia conditions: Ventilator Lung studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: open, randomised control trial primaryPurpose: PREVENTION masking: NONE count: 43 type: ESTIMATED name: Driving pressure-guided positive end expiratory pressure name: Optimal oxygenation-guided positive end expiratory pressure name: Ventilation strategy name: Management of hypoxemia measure: The incidence of postoperative hypoxemia measure: The trend of perioperative oxygenation function measure: Postoperative pulmonary complications except hypoxemia measure: Early/late death measure: Vasoactive-inotropic score at the end of surgery measure: Postoperative adverse cardiovascular events measure: Length of stay in intensive care unit measure: Ventilation assistance time measure: Postoperative extrapulmonary complications sex: ALL minimumAge: 14 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian medical university union hospital status: RECRUITING city: Fuzhou state: Fujian zip: 350001 country: China name: Yong Lin, MD role: CONTACT phone: 13805064575 email: [email protected] lat: 26.06139 lon: 119.30611 hasResults: False
<|newrecord|> nctId: NCT06361407 id: 2023-A02464-41 briefTitle: Sensory and Cognitive Predictions, and Their Disruptions in Schizophrenia acronym: SensoSchiz overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-30 date: 2028-02-28 date: 2024-04-11 date: 2024-04-11 name: Centre Psychothérapique de Nancy class: OTHER name: Institut National de la Santé Et de la Recherche Médicale, France briefSummary: Disturbances in the sense of self and time could play an important role in the development of psychotic symptoms. Previous work has shown that patients have difficulty preparing to process information on the scale of a second, but are abnormally disturbed by slightly asynchronous information on the millisecond scale. In both cases, the anomalies could explain the patients' unusual experience of time. The hypothesis in neurotypical patients is that small delays or asynchronies asynchronies are treated as irrelevant information and ignored and ignored, whereas in patients suffering from schizophrenia they would disrupt the flow of time. This hypothesis is tested with a new visual illusion. conditions: Schizophrenia conditions: Sensory Processing Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Individuals with schizophrenia will be tested in parallel with neurotypicals primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: The group will be masked at the stage of data analysis. It cannot be masked at the prior stages count: 68 type: ESTIMATED name: Illusion task measure: Effect of a millisecond-level trajectory perturbation measure: Baseline rate of illusion measure: Effect of a rebound (top-down, conscious influence) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06361394 id: CORPFIN0021 briefTitle: The Impacts of Mindfulness on Psychological Wellbeing Among Nursing Students overallStatus: RECRUITING date: 2024-02-20 date: 2024-07-25 date: 2025-08-31 date: 2024-04-11 date: 2024-04-11 name: Chang Gung University of Science and Technology class: OTHER briefSummary: The aims of this study are to develop a mindfulness-based course for nursing students. As well as, to verify the effects on psychological well-being (mindfulness, stress, and anxiety) and nursing professional related competences (empathy, clinical practicum stress, nursing competency) among nursing students. conditions: Students studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The experimental group will enroll in the elective course named "Mindfulness and Happiness," which will consist of 2 hours every week for a continuous period of 18 weeks. The comparison group will not participate in this course. primaryPurpose: TREATMENT masking: NONE count: 240 type: ESTIMATED name: mindfulness course measure: perceived stress at baseline measure: perceived stress at T0 measure: perceived stress at T1 measure: perceived stress at T2 measure: anxiety disorder at baseline measure: anxiety disorder at T0 measure: anxiety disorder at T1 measure: anxiety disorder at T2 measure: mindful attention awareness at baseline measure: mindful attention awareness at T0 measure: mindful attention awareness at T1 measure: mindful attention awareness at T2 measure: empathy at baseline measure: empathy at at T0 measure: empathy at at T1 measure: empathy at at T2 measure: practicum stress at T1 measure: practicum stress at T2 measure: Nursing Competence at T1 measure: Nursing Competence at T2 sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Ya-Chu Hsiao status: RECRUITING city: Taoyuan City state: N/A = Not Applicable zip: 333 03 country: Taiwan name: ya-chu hsiao, EdD role: CONTACT phone: +886939740890 email: [email protected] lat: 24.95233 lon: 121.20193 hasResults: False
<|newrecord|> nctId: NCT06361381 id: 24-01-281 briefTitle: The Combined Effect of TENS and TaVNS on Pressure and Heat Pain Thresholds in Pain-Free Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-12 date: 2024-04-11 date: 2024-04-11 name: University of Hartford class: OTHER briefSummary: Transcutaneous electrical nerve stimulation (TENS) is a non-invasive modality that utilizes electrical currents to modulate pain in populations with acute and chronic pain. TENS has been demonstrated to produce hypoalgesic effects in postoperative pain, fibromyalgia, knee osteoarthritis, and healthy subjects. Transcutaneous auricular vagus nerve stimulation (TaVNS) is a non-invasive modality that modulates the vagus nerve by stimulating its auricular branches. The effects of the combination of TENS and TaVNS on producing an analgesic response have not been studied. Considering that TENS and TaVNS both stimulate similar analgesic pathways but through different means of activation, the investigators can hypothesize that a combination of both methods can produce a more pronounced analgesic response. Therefore, the objective of this study is to assess the hypoalgesic effect of a combination of TENS and TaVNS in pain-free subjects.
The study will be a simple crossover design conducted at the University of Hartford. Subjects will be recruited from the University of Hartford population via oral communication, digital flyers, and posters on campus. Thirty participants will undergo two sessions in a crossover manner with one week in between. During one session, the participants will receive TENS with active TaVNS and the other session will be a placebo procedure (TENS with placebo TaVNS). The order of these sessions will be randomized. Importantly, the pressure pain threshold (PPT) and heat pain threshold (HPT) assessors will be blinded to the treatment category. For active TaVNS, a frequency of 25 Hz will be applied with a pulse duration of 200 µs. For placebo TaVNS, the intensity will be increased to a sensory level and then decreased to 0 mA. High frequency TENS of 100Hz will be applied in both sessions, with a pulse duration of 200 µsec, asymmetrical biphasic square waveform, and intensity of maximal tolerance without pain. TENS and TaVNS will be turned on for 30 minutes after a baseline measurement of outcomes. TENS and TaVNS will then be turned off, but the electrodes will remain on until completion of post-treatment assessment. Pressure pain threshold, heat pain threshold, blood pressure, oxygen saturation and heart rate will be tested 4 times: Once pre-intervention, once during intervention, once immediately after the intervention and once 15 minutes post-intervention. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) name: Placebo Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) name: Transcutaneous Electrical Nerve Stimulation measure: Pressure Pain Threshold measure: Heat Pain Threshold measure: Heart rate measure: Oxygen saturation measure: Blood pressure sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Hartford city: West Hartford state: Connecticut zip: 06117 country: United States lat: 41.76204 lon: -72.74204 hasResults: False
<|newrecord|> nctId: NCT06361368 id: NYCU112174AF briefTitle: Efficacy Assessment of Probiotics in Improving Sleep Indices overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2026-03 date: 2024-04-11 date: 2024-04-11 name: National Yang Ming University class: OTHER name: Bened Biomedical Co., Ltd. briefSummary: To determine whether PS150 (1) reduces insomnia symptoms, (2) improves sleep quality, (3) adjusts autonomic nervous system functioning, (4) reduces the severity of anxiety and depressive symptoms, and (5) adjusts microbiome and endocrine functions. conditions: Insomnia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: PS150 name: Placebo measure: Polysomnography (PSG) measure: Pittsburgh Sleep Quality Index (PSQI) measure: Insomnia Severity Index (ISI) measure: Beck Depression Inventory-Second Edition (BDI-II) measure: Beck Anxiety Inventory (BAI) measure: VAS-Sleep measure: Epworth Sleepiness Scale (ESS) measure: Standford Sleepiness Scale (SSS) measure: Visual Analogue Scale for gastrointestinal symptoms (VAS-GI) measure: Saliva Melatonin measure: Saliva Cortisol measure: Saliva IL-6 measure: Saliva Total Antioxidant Capacity (TAC) measure: Saliva Serotonin measure: Saliva GABA measure: Saliva Orexin measure: Urine 6-sulfatoxymelatonin measure: Urine Norepinephrine measure: Actigraphy measure: Sleep Diary sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Institute of Brain Science National Yang Ming Chiao Tung University city: Taipei zip: 112304 country: Taiwan name: Yu En Kuo, Master role: CONTACT phone: +886 975231262 email: [email protected] lat: 25.04776 lon: 121.53185 hasResults: False
<|newrecord|> nctId: NCT06361355 id: CMAB807-I-002 briefTitle: Study of CMAB807 Post-change in Manufacturing Site and Prolia in Healthy Volunteers overallStatus: RECRUITING date: 2023-11-02 date: 2024-04 date: 2024-06 date: 2024-04-11 date: 2024-04-11 name: Taizhou Mabtech Pharmaceutical Co.,Ltd class: INDUSTRY briefSummary: This is a randomized, double-blinded, parallel-controlled Phase I study of CMAB807 administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of CMAB807 Post-change in Manufacturing Site, versus Prolia #Denosumab# in healthy male subjects after a single dose conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Biological: Post-change CMAB807, Prolia primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 132 type: ESTIMATED name: Post-change CMAB807 name: Prolia measure: Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time measure: Maximum Concentration of Denosumab measure: Time to Maximum Concentration of Denosumab measure: Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 3000 Hours measure: Half-time measure: Clearance Rate measure: Apparent Volume measure: Serum type 1 C-telopeptide (CTX1) measure: anti-drug antibodies(ADA) measure: Neutralization antibodies(Nab) measure: Percentage and Severity of Participants with Adverse Events sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: The Second Hospital of Anhui Medical University status: RECRUITING city: Hefei state: Anhui country: China name: Hu Wei, Doctor role: CONTACT phone: 0551-65997164 email: [email protected] lat: 31.86389 lon: 117.28083 hasResults: False
<|newrecord|> nctId: NCT06361342 id: 23-003633 briefTitle: Smartphones Aggravating Anxiety Symptoms overallStatus: ENROLLING_BY_INVITATION date: 2024-03-08 date: 2025-03 date: 2025-03 date: 2024-04-11 date: 2024-04-11 name: Mayo Clinic class: OTHER briefSummary: The goal of this study is to assess if excessive use of smartphone apps of social media can impact a person's mental health. The study is aimed at improving the usage of smartphones which might help improve the mental health of patients. The goal is not to discourage the use of smartphones but instead to utilize smartphones in a way that they do not impact lives. conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: General decrease in smartphone use name: Avoiding Social Media Apps measure: Change in anxiety measure: Change in depression 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
<|newrecord|> nctId: NCT06361329 id: 20240030C briefTitle: Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in Newly Diagnosed ETP-ALL overallStatus: RECRUITING date: 2024-04 date: 2026-03-31 date: 2027-03-31 date: 2024-04-11 date: 2024-04-29 name: First Affiliated Hospital of Zhejiang University class: OTHER briefSummary: ETP-ALL is a subtype of T-cell acute lymphoblastic leukemia (T-ALL) with poor outcomes and prognosis. Effective induction therapy is crucial in improving the treatment effect. Based on our laboratory research and clinical practice, the venetoclax plus HAG regimen shows promising efficacy in treating ETP-ALL. Therefore, we plan to conduct a prospective, multicenter Phase III clinical study to evaluate the efficacy of the venetoclax plus HAG regimen in treating newly diagnosed ETP-ALL patients. conditions: ETP-ALL studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 81 type: ESTIMATED name: Homoharringtonine name: venetoclax name: Cytarabine name: G-CSF name: Vindesine name: Daunorubicin name: cyclophosphamide name: Dexamethasone name: L-ASP measure: 1-year EFS measure: CR/CRi measure: OS measure: MRD measure: Safety of induction therapy sex: ALL minimumAge: 14 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital, College of Medicine, Zhejiang University status: RECRUITING city: Hangzhou state: Zhejiang zip: 310003 country: China name: Jie Jin, PhD&MD role: CONTACT phone: 13705716779 email: [email protected] lat: 30.29365 lon: 120.16142 hasResults: False
<|newrecord|> nctId: NCT06361316 id: CSPC-DEY-PC-JS01 briefTitle: Irinotecan Liposome Combined With Oxaliplatin and Tegafur as Adjuvant Therapy for Pancreatic Cancer overallStatus: RECRUITING date: 2024-04-08 date: 2025-03-25 date: 2028-07-31 date: 2024-04-11 date: 2024-04-11 name: Kuirong Jiang class: OTHER name: CSPC Ouyi Pharmaceutical Co., Ltd. briefSummary: The purpose of this study is to evaluate the efficacy and safety of irinotecan liposome injection in combined with oxaliplatin plus tegafur (NASOX) for postoperative adjuvant chemotherapy for pancreatic cancer. conditions: Pancreatic Cancer conditions: Adjuvant Therapy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 53 type: ESTIMATED name: Irinotecan liposome injection measure: Disease Free Survival, DFS measure: Adverse events (aes) were determined and graded according to NCI-CTCAE version 5.0, and evaluated by the overall incidence of AE, the incidence of AE grade 3 or above, and the incidence of SAE measure: Overall Survival, OS measure: Quality of life, QOL measure: The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy measure: he results were presented in terms of the proportion of patients who were replaced with 5-FU/LV due to Tegafur intolerance sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: FirstNanjingMU status: RECRUITING city: Nanjing state: Jiangsu zip: 025 country: China name: KuiRong Jiang, archiater role: CONTACT phone: 15312995688 email: [email protected] name: Min Tu, associate doctor role: SUB_INVESTIGATOR lat: 32.06167 lon: 118.77778 hasResults: False
<|newrecord|> nctId: NCT06361303 id: PS230001 id: PS230001 / PSS001 type: OTHER domain: US FDA briefTitle: The Happiest Baby, Inc. SNOO Postmarket Surveillance Study overallStatus: RECRUITING date: 2023-11-29 date: 2025-09 date: 2025-09 date: 2024-04-11 date: 2024-04-11 name: Happiest Baby, Inc. class: INDUSTRY briefSummary: This postmarket surveillance study will evaluate the safety of the SNOO Smart Sleeper Bassinet when used for infants who are at high risk for Sudden Unexpected Infant Death (SUID). This study will survey 1000 caregivers of high-risk infants to examine the frequency of death or serious injury occurring in the SNOO Bassinet. conditions: Infant Death conditions: Serious Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: SNOO Bassinet measure: Serious Injury measure: Infant death measure: Infant age during SNOO use measure: Degree of SNOO use measure: Weaning rationale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Happiest Baby, Inc. status: RECRUITING city: Los Angeles state: California zip: 90064 country: United States name: Christopher Laine, PhD role: CONTACT phone: 310-476-4440 email: [email protected] name: Sarah Chang, MPH role: CONTACT phone: 310-476-4440 email: [email protected] name: Christopher Laine, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False
<|newrecord|> nctId: NCT06361290 id: APHP231703 briefTitle: Diaphyseal Reconstruction of Malignant Tumors in Children acronym: RDTM overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2024-10 date: 2024-04-11 date: 2024-04-11 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Primary malignant bone tumors represent 5% of malignant tumors in children, 90% of which are osteosarcomas or Ewing sarcomas.
The objective of oncological resection is local control of the disease. Excision of the entire tumor should make it possible to maintain good function of the limb, minimizing morbidity, and promoting acceptance by the patient.
Biological reconstructions offer the best long-term functional results. Several possibilities are then available: the Induced Membrane technique, the Vascularized Fibula and Vascularized Fibula associated with an Allograft.
Until today, no reconstruction technique in children has proven its superiority over another and no decision-making algorithm for therapeutic care has been determined based on the importance of the bone resection and the affected segment in diaphyseal tumor reconstruction surgery of the lower limb.
The aim of the present research is to compare the three techniques concerning the consolidation aspect, the reoperation rates, the rates of bone complications, septic, and the functional results by the study of the medical files of approximately 90 patients operated between 1986 and 2017. conditions: Childhood Malignant Tumors of Lower Limbs studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 90 type: ESTIMATED name: Data collection from hospital medical records measure: Duration of bone consolidation period measure: Rate of surgical re-intervention measure: Short- and long-term complication rates measure: Long-term functional results measure: Relationship between radiotherapy and biological reconstruction result sex: ALL maximumAge: 17 Years stdAges: CHILD facility: Hôpital Armand-Trousseau city: Paris zip: 75012 country: France name: Franck Fitoussi, MD-PhD role: CONTACT phone: 679693634 phoneExt: +33 email: [email protected] lat: 48.85341 lon: 2.3488 facility: Hôpital Necker-Enfants Malades city: Paris zip: 75015 country: France name: Edouard Haumont, MD role: CONTACT phone: 486587192 phoneExt: +32 email: [email protected] lat: 48.85341 lon: 2.3488 hasResults: False
<|newrecord|> nctId: NCT06361277 id: JW22104 briefTitle: To Evaluate the Pharmacokinetic Characteristics and Safety in Healthy Volunteers overallStatus: COMPLETED date: 2023-11-03 date: 2023-11-20 date: 2023-11-27 date: 2024-04-11 date: 2024-04-11 name: JW Pharmaceutical class: INDUSTRY briefSummary: The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0202 and C2202 and co-administration of C2205 and JW0201 in healthy volunteers under fasting conditions conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 56 type: ACTUAL name: Reference Drug or Test Drug measure: AUCt measure: Cmax sex: ALL minimumAge: 19 Years maximumAge: 55 Years stdAges: ADULT facility: Clinical Trial Center, Jeonbuk National University Hospital city: Jeonju country: Korea, Republic of lat: 35.82194 lon: 127.14889 hasResults: False
<|newrecord|> nctId: NCT06361264 id: Karanahan briefTitle: Clinical Study of Personalized Chemotherapy for Breast Cancer With Low Doses of Cyclophosphamide overallStatus: RECRUITING date: 2018-11-01 date: 2024-12-01 date: 2025-12-01 date: 2024-04-11 date: 2024-04-11 name: KARANAHAN class: OTHER briefSummary: The goal of this study is to evaluate the safety and clinical efficacy of personalized chemotherapy with low doses of cyclophosphamide administered taking into account the reparative cycle of tumor cells in participants with breast cancer (stage IV or disease progression). The main question it aims to answer is: Does personalized chemotherapy of breast cancer with low doses of cyclophosphamide, taking into account the reparative cycle of tumor cells, lead to a significant reduction in tumor size and improvement in the visual status of controlled tumor foci relative to their initial state? During the preparatory stage, a tumor sample from participant is harvested intraoperatively. The primary culture is obtained from this tumor tissue sample. Repair cycle time is estimated, and the day when tumor cells are synchronized at the cell cycle G2/M phase is identified. The schedule of administering cyclophosphamide and DNAmix complex composite preparation is calculated according to the resulting time points. According to the elaborated regimen, the participant receives 4 intravenous cyclophosphamide injections at the dose of 300 mg/m2 in combination with 4 injections of 1-12 mg of DNAmix administered into prominent tumor nidi and lymph depots. The participant receives from 2 to 6 courses of therapy. The interval between courses is 21 days. conditions: Stage IV Breast Cancer studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Karanahan measure: The size of tumor foci measure: The quality of life score measure: The immunomodulatory effect sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karanahan Llc status: RECRUITING city: Novosibirsk state: Novosibirsk Region zip: 630090 country: Russian Federation name: Anastasia Proskurina role: CONTACT email: [email protected] name: Sergey Sidorov role: PRINCIPAL_INVESTIGATOR lat: 55.0415 lon: 82.9346 hasResults: False
<|newrecord|> nctId: NCT06361251 id: CS5_10 briefTitle: Interventional, Monocentric, Double-blind Randomized Category 2b Study Evaluating the Evaluation of the Tolerance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post -Inflammatory Hyperpigmentation (Pih)) on the Face acronym: CS5_10 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-11 date: 2024-04-17 name: Cryonove Pharma class: INDUSTRY name: Dermatech briefSummary: The goal of this clinical trial is to compare the 2 different prototype of cytoselectivecryotherapy 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 2 prototypes of cyto-selective cryotherapy treatments
* the performance of 2 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 2 prototypes of cyto-selective cryotherapy devices corresponding to a modified CE marked medical device (ref: 822-v1). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double blind (participant and care provider) whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: CRYONOVE (EC14_4osc) name: CRYONOVE (EC05osc) measure: Tolerance measure: Performance (Acquisitions C-cube) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SMU - Photobiology Laboratory, Sefako Makgatho Health Sciences University city: Pretoria country: South Africa lat: -25.74486 lon: 28.18783 hasResults: False
<|newrecord|> nctId: NCT06361238 id: 2023-LCYJ-PY-21 briefTitle: Liraglutide in Preventing Delirium in Diabetic Elderly After Cardiac Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-03-31 date: 2027-03-31 date: 2024-04-11 date: 2024-04-11 name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School class: OTHER briefSummary: This study aims to clarify the preventive effect of perioperative liraglutide application on postoperative delirium in elderly patients with Type 2 diabetes undergoing cardiac surgery. conditions: Delirium, Postoperative studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 260 type: ESTIMATED name: Liraglutide injection name: Placebo injection measure: The incidence of delirium measure: The severity of delirium measure: Cognitive function measure: Anxiety measure: Depression measure: Duration of ICU stay measure: Mechanical ventilation time measure: Duration of hospital stay measure: In-hospital mortality measure: Incidence of adverse events measure: Rate of major cardiovascular adverse events measure: Serum levels of NSE measure: Serum levels of CRP measure: Serum levels of IL-1α measure: Serum levels of TNF-α measure: Serum levels of C3 measure: Serum levels of LDH measure: Serum levels of CK measure: Serum levels of CK-MB measure: Serum levels of AST measure: Serum levels of cTNT measure: Serum levels of BNP measure: Serum levels of C1q measure: Serum levels of IL-1β measure: Serum levels of IL-6 measure: Serum levels of S100β measure: Left Ventricular Posterior Wall Thickness in Diastole (LVPWTd) measure: Left Ventricular End-Diastolic Dimension (LVDd) measure: Left Ventricular End-Systolic Diameter (LVDs) measure: Left Atrial Diameter (LAD) measure: Ejection Fraction (EF) measure: Fractional Shortening (FS) measure: Early Diastolic Velocity/Atrial Diastolic Velocity (E/A) measure: Interventricular Septum Thickness in Diastolic (IVSTd) sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06361225 id: 0075-24-MMC briefTitle: Routine Use of RUSH Protocol in the Intensive Care Unit overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-08-01 date: 2025-08-01 date: 2024-04-11 date: 2024-04-11 name: Meir Medical Center class: OTHER briefSummary: The RUSH protocol has been used for several years for the rapid evaluation of a patient admitted to the emergency room with shock. Traditionally, its use was especially common in trauma victims, but later its use was extended to patients admitted to the emergency room with shock from any reason. The protocol includes rapid assessment with the guideness of ultrasound of heart contraction, assessment for pleural effusions, assessment of intra-abdominal blood (FAST), diagnosis of venous thrombosis (DVT), and rulling out hydronephrosis. It can also add a pupil size assessment and an evaluation of the gallbladder and bile ducts, as well as the size of the bladder. In intensive care, we use this protocol (or part of it) for the evaluation of a patient who is deteriorating in the ICU for an unknown reason . In some patients we use this protocol as a routine part of the physical examination as part of the daily patient evaluation.
We would like to investigate whether the routine use of the RUSH protocol as part of the daily patient evaluation in the general intensive care unit will lead to any change in the patient's management. conditions: RUSH Protocol studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: evaluation with RUSH protocol measure: Change of patient medical therapy measure: Performing unplanned laboratory tests measure: Performing unplanned image tests measure: Performing unplanned invasive procedure sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Meir Medical Center city: Kfar Saba country: Israel lat: 32.175 lon: 34.90694 hasResults: False
<|newrecord|> nctId: NCT06361212 id: BJXH-2022-002 briefTitle: Ethoximod Pharmacokinetics In Healthy Subjects overallStatus: COMPLETED date: 2022-09-01 date: 2022-09-20 date: 2024-01-12 date: 2024-04-11 date: 2024-04-11 name: Longevity Inc. class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Ethoximod in healthy subjects. The main questions it arms to answer are:
1. to evaluate the safety and tolerance of Ethoximod in healthy subjects after single or repeated doses.
2. to assess the pharmacokinetics and pharmacodynamics of Ethoximod in healthy subjects after single or repeated doses.
3. to evaluate of the effect of food on the pharmacokinetics of Ethoximod in healthy subjects Participants will receive test tablets or placebo at the indicated date and collect blood samples. conditions: Psoriasis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 65 type: ACTUAL name: Ethoximod measure: Peak plasma concentration (Cmax) measure: Time to peak plasma concentration (Tmax) measure: The lowest plasma concentration (Cmin) measure: Half-life (t1/2) measure: Number of adverse events and number of participants with adverse events measure: Lymphocyte count measure: Percentage of CD3+CD4+ and CD3+CD8+ T cells sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: The first hospital of Jilin University city: Changchun state: Jilin country: China lat: 43.88 lon: 125.32278 hasResults: False
<|newrecord|> nctId: NCT06361199 id: BJXH-2021-001 briefTitle: Proximod Pharmacokinetics in Healthy Subjects and Patients With Rheumatoid Arthritis overallStatus: COMPLETED date: 2021-12-16 date: 2022-02-16 date: 2023-10-08 date: 2024-04-11 date: 2024-04-19 name: Longevity Inc. class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Proximod in healthy subjects and patients with rheumatoid arthritis. The main questions it arms to answer are:
1. to evaluate the safety and tolerance of Proximod in health subjects after repeated doses.
2. to assess the pharmacokinetics and pharmacodynamics of Proximod in healthy subjects after repeated doses.
3. to evaluate the safety and tolerance of Proximod in patients with rheumatoid arthritis.
4. to evaluate the pharmacokinetics and pharmacodynamics of Proximod in patients with rheumatoid arthritis.
Participants will receive test tablets or placebo at the indicated date and collect blood samples. conditions: Rheumatoid Arthritis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 22 type: ACTUAL name: Proximod name: Placebo measure: Peak plasma concentration (Cmax) measure: Time to peak plasma concentration (Tmax) measure: The lowest plasma concentration (Cmin) measure: Half-life (t1/2) measure: Area under the plasma concentration versus time curve (AUC) measure: Number of adverse events and number of participants with adverse events measure: Lymphocyte count measure: Percentage of CD3+CD4+ and CD3+CD8+T cells measure: ACR20 score in Patients With Rheumatoid Arthritis measure: Disease Activity Score（DAS28-CRP）in Patients With Rheumatoid Arthritis sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The first hospital of Jilin University city: Changchun state: Jilin country: China lat: 43.88 lon: 125.32278 hasResults: False
<|newrecord|> nctId: NCT06361186 id: BJXH-2017-001 briefTitle: Proximod Pharmacokinetics In Healthy Subjects overallStatus: COMPLETED date: 2017-09-14 date: 2017-11-01 date: 2021-06-22 date: 2024-04-11 date: 2024-04-11 name: Longevity Inc. class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Proximod in healthy subjects. The main questions it arms to answer are:
1. to evaluate the safety and tolerance of Proximod in healthy subjects after single or repeated doses.
2. to learn the pharmacodynamics of Proximod in healthy subjects after single or repeated doses.
3. to evaluation of the effect of food on the pharmacokinetics of Proximod in healthy subjects Participants will receive test tablets or placebo at the indicated date and collect blood samples. conditions: Rheumatoid Arthritis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 134 type: ACTUAL name: Proximod name: Placebo measure: Peak plasma concentration (Cmax) measure: Time to peak plasma concentration (Tmax) measure: The lowest plasma concentration (Cmin) measure: Half-life (t1/2) measure: Number of adverse events and number of participants with adverse events measure: Lymphocyte count measure: Percentage of CD3+CD4+ and CD3+CD8+ T cells sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: The first hospital of Jilin University city: Changchun state: Jilin country: China lat: 43.88 lon: 125.32278 hasResults: False
<|newrecord|> nctId: NCT06361173 id: STUDY00004127 briefTitle: Spanish BMT4me Usability & Acceptability overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-05-01 date: 2026-05-01 date: 2024-04-11 date: 2024-04-11 name: Nationwide Children's Hospital class: OTHER name: Columbia University briefSummary: The objective of this project is to trans-create, conduct user testing of a previously developed and piloted mHealth app, and user acceptability with parents of children in the acute phase post-allogeneic hematopoietic stem cell transplant (HSCT). Nationwide Children's Hospital (NCH) will be the primary data collection site and Columbia University Irving Medical Center will be a secondary site. conditions: Bone Marrow Transplant studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED name: BMT4me measure: Assess app usability using the System Usability Scale (SUS) sex: ALL minimumAge: 0 Years maximumAge: 17 Years stdAges: CHILD facility: Columbia University Irving Medical Center city: New York state: New York zip: 10027 country: United States name: Melissa Beauchemin role: CONTACT email: [email protected] lat: 40.71427 lon: -74.00597 facility: Nationwide Children's Hospital city: Columbus state: Ohio zip: 43215 country: United States name: Bianca Franklin, BS role: CONTACT name: Micah Skeens, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False
<|newrecord|> nctId: NCT06361160 id: D23-P037 briefTitle: Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation acronym: HALLUSTIM overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-11 date: 2024-04-11 name: Centre Hospitalier St Anne class: OTHER briefSummary: Approximately 1% of the general population will be affected by schizophrenia over the course of their lives, with life expectancy being reduced by 20 years on average and quality of life being severely diminished in affected individuals. One third of patients suffering from schizophrenia will evolve towards a resistant form of the disease, amongst which many will suffer from auditory-verbal hallucinations (AVH) that current therapeutic approaches struggle to alleviate. Previous work from our team has demonstrated the possibility of robustly inferring the periods of occurrence of AVH from fMRI data, paving the way for the development of a closed-loop neuromodulation system comprised of an electrode array positioned in Broca's area, which would detect AVH in real time, and effector electrodes which would stimulate the temporo-parietal cortex to interrupt them. The aim of this project is to assess the feasibility of this system. To do so, we will first test the ability of transcranial magnetic stimulation of the "continuous theta burst" (cTBS) type, applied at the time of AVH onset, to reduce their duration and intensity, and assess whether this is associated with therapeutic response to the current gold standard rTMS protocol for AVH reduction through neuroplasticity induction. Demonstrating the feasibility of acute suppression of AVH by cortical neurostimulation is an essential element in the feasibility of a closed-loop reactive neuromodulation system.
The research project comprises two phases:
-Phase 1: randomized controlled clinical trial (1 weekly session per patient over 12 weeks: 6 active stimulation sessions and 6 sham sessions) evaluating the phasic effects of rTMS on AVHs as they appear during the sessions.
Phase 2: open-label study offering patients a routine rTMS protocol which has demonstrated its effects on AVH (10 TMS sessions over one workweek - twice daily with 1-hour intervals, MULTIMODHAL study, NCT01373866). conditions: Treatment Resistant Schizophrenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Patients (20) suffering from resistant schizophrenia will be enrolled over a 12-month period and will be randomized in a (1:1) ratio to start with either active or sham Transcranial Magnetic Stimulation (TMS) for the first of their 12 sessions, which will then alternate from one condition to the other for each patient. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Only the person conducting the experiment will know which condition each patient is in. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Active Transcranial Magnetic Stimulation (TMS) name: Sham Transcranial Magnetic Stimulation (TMS) measure: Duration of auditory-verbal hallucinations measure: Clinical scales scores measure: Measure of the duration and/or intensity of HAV (in seconds) during active phasic stimulation sessions compared to sham sessions (phase 1) among TMS responders and non-responders in phase 2 measure: Intensity of auditory-verbal hallucinations sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06361147 id: 3764/2-10-2019 briefTitle: Psychoeducation of Adult Siblings of ASD People (Autism Spectrum Disorder). overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-28 date: 2024-07 date: 2024-10 date: 2024-04-11 date: 2024-04-11 name: Hellenic Mediterranean University class: OTHER briefSummary: The aim of this study is to apply a psychoeducational program in adult siblings of people with ASD as a means to provide knowledge related to the disorder and improving their quality of life.
The psycho-educational program will be implemented in adult siblings of people with ASD and its effectiveness will be assessed.
Participation in this program is expected to contribute in the improvement of the quality of life of the participants, their siblings with ASD and those related to them. No risk is identified. conditions: Autism Spectrum Disorder conditions: Sibling Relations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Interventional groups and Control groups primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 88 type: ACTUAL name: Cygnet program for ASD measure: Psychoeducation effectiveness on siblings of ASD measure: Psychoeducation effectiveness on the knowledge of ASD measure: Psychoeducation effectiveness on siblings relationship measure: Psychoeducation effectiveness on resilience of siblings of ASD measure: Psychoeducation effectiveness on the well-being of siblings of ASD sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hellenic Mediterranean University city: Heraklion state: Crete zip: 82102 country: Greece lat: 35.32787 lon: 25.14341 hasResults: False
<|newrecord|> nctId: NCT06361134 id: 14574941-302,08,01- briefTitle: Efficacy of Supporting SAFE Early Intervention overallStatus: COMPLETED date: 2021-01-15 date: 2022-05-15 date: 2022-11-15 date: 2024-04-11 date: 2024-04-11 name: Gazi University class: OTHER briefSummary: Within the scope of the study, it was planned that risky babies would be treated with the SAFE early intervention approach for 10 weeks after they were discharged from the intensive care unit. Neurodevelopmental Treatment was applied to the control group. Sensory, motor and language development of the babies were evaluated before and after the intervention. conditions: Infant Development conditions: Physiotherapy conditions: Early Intervention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 26 type: ACTUAL name: SAFE Early İntervention name: NDT based therapy measure: Test of Infant Motor Profile measure: Bayley Scales of Infant and Toddler Development, Third Edition, measure: Infant/Toddler Sensory Profile 2 measure: Infant/Toddler HOME Inventory sex: ALL minimumAge: 1 Month maximumAge: 3 Months stdAges: CHILD facility: Erzurum Technical University city: Erzurum country: Turkey lat: 39.90861 lon: 41.27694 hasResults: False
<|newrecord|> nctId: NCT06361121 id: D361 briefTitle: Mid-point Transverse Process to Pleura Block Versus Thoracic Paravertebral Block in Posterolateral Thoracotomy overallStatus: RECRUITING date: 2024-03-01 date: 2025-03 date: 2025-03 date: 2024-04-11 date: 2024-04-11 name: Fayoum University Hospital class: OTHER briefSummary: The ultrasound guided Thoracic paravertebral (TPV) block in the context of posterolateral thoracotomy offers targeted pain relief by anesthetizing the spinal nerves as they emerge from the intervertebral foramina, producing ipsilateral somatosensory, visceral and sympathetic nerve blockade. TPV block involves the injection of local anesthetic (LA) into the wedge-shaped paravertebral space deep to the superior costotransverse ligament (SCTL)
Costach et al introduced the mid-point transverse process to pleura block (MTP) as a modification of conventional paravertebral block by placing the LA posterior to the (SCTL) under ultrasound guidence achieving an effective block without the necessity to approach the pleura and the attendant risks.
In recent studies ,the ultrasound guided MTP block provided an effective analgesia in various surgical procedures including mastectomy , video-assisted thoracic surgeries and cardiac surgeries.
In our study we hypothesized that the mid-point transverse process to pleura (MTP) block can provide an effective analgesia comparable with thoracic paravertebral (TPV) block in adult patients undergoing posterolateral thoracotomy incisions. conditions: Bronchiectasis conditions: Lung Neoplasm conditions: Emphysematous Bleb of Lung studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The patients will be randomized into two groups: MTP block group and TPV block group in a 1:1 ratio using a computer-generated random table. The patient's assigned group information will be elicited from a sealed opaque envelope by the anesthesiologist who will perform the US-guided MTP and TPV block and will not be involved in further data collection or patient care. The patients and both the surgical and anesthesia teams, who are responsible for patient care and data collection are blinded from the group assignments whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: mid-point transverse process to pleura (MTP) block name: Thoracic Paravertebral Block measure: The total postoperative fentanyl consumption measure: Demographic data measure: visual analogue scale score both during rest and with cough measure: intra operative fentanyl consumption measure: Duration of surgery measure: Blood pressure measure: Heart rate measure: Oxygen saturation measure: complications related to the block measure: complications related to IV opioids measure: Hospital length of stay in days measure: Participant satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fayoum University Hospital status: RECRUITING city: Fayoum zip: 63514 country: Egypt name: Mohamed A Hamed, MD role: CONTACT phone: 01010509736 phoneExt: +20 email: [email protected] name: Mohamed A Hamed, MD role: PRINCIPAL_INVESTIGATOR lat: 29.30995 lon: 30.8418 hasResults: False
<|newrecord|> nctId: NCT06361108 id: YJ001-103 briefTitle: Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of YJ001 for Spray Use in Patients With Diabetic Peripheral Neuropathic Pain overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2025-03-20 date: 2025-03-20 date: 2024-04-11 date: 2024-04-11 name: Zhejiang Hanmai Pharmaceutical Technology Co., Ltd. class: INDUSTRY briefSummary: This Phase I, randomized, double-blind and placebo controlled study is to evaluate the safety, tolerability, and PK, and to preliminarily assess the efficacy of topically administered YJ001 in a multiple-ascending dose (MAD) fashion in the patients with DPNP. The study will be conducted at a single study center.
In this study, 2 cohorts (N=24, 12 subjects for each cohort), each cohort will consist of 10 active and 2 placebo, with approximately equal numbers of male and female subjects.
Each subject will be administered a single dose of YJ001 as multiple sprays topically on both feet and below the ankle in the morning on Day 1 and Day 2, and will be administered as twice daily doses once in the morning and the other in the evening (with an interval of 11 to 13 h) from Day 3 through Day 11. conditions: Diabetic Peripheral Neuropathic Pain studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-blinded with regard to the study treatment that subjects receive,without the investigator, the sponsor, or the subjects being aware of wether YJ001 or the placebo is administered. All decisions concerning dose escalation will be made in a blinded manner by the safety review committee.
The Safety Review Committee (SRC), comprised of the Principal Investigator, Medical Monitor, and Sponsor's qualified designee, will convene after completion of each cohort to evaluate available safety, PK, and other relevant data.
The SRC will determine whether to proceed to the next planned dose level, continue with the study and add additional safety evaluations, expand the number of subjects at the current level, reduce the dose, or stop the study. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: YJ001 for Spray Use name: Placebo of YJ001 for Spray Use measure: Safety Assessments - AEs measure: Safety Assessments -Number of Participants With Abnormal Laboratory Values measure: Safety Assessments - Skin Reaction measure: Pharmacokinetics-AUC measure: Pharmacokinetics- Cmax measure: Pharmacokinetics - tmax measure: Pharmacokinetics - tlag measure: Pharmacokinetics - t1/2 measure: Pharmacokinetics - CLr/f,ss measure: Efficacy evaluation indicator measure: Efficacy evaluation indicators - ADSIS measure: Efficacy evaluation indicators - SF-MPQ measure: Efficacy evaluation indicators - VPT sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Trials of Texas,LLC city: Fredericksburg state: Texas zip: 78229 country: United States name: Douglas Scott Denham role: CONTACT phone: 210-949-0122 lat: 30.2752 lon: -98.87198 hasResults: False
<|newrecord|> nctId: NCT06361095 id: R01GABM briefTitle: Confirmatory Efficacy Trial of Attention Bias Modification for Depression overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-03-01 date: 2028-03-01 date: 2024-04-11 date: 2024-04-16 name: University of Texas at Austin class: OTHER name: Arcade Therapeutics briefSummary: The goal of this clinical trial is to compare the efficacy of two related, but different ABM (Attention Biased Modification) treatments for depression in adults with elevated symptoms of depression. The main aims are: