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<|newrecord|> nctId: NCT06372795 id: KY2023635 briefTitle: Resistance Swallowing Training in Patients With Tracheotomy overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-12-31 date: 2024-04-18 date: 2024-04-18 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: The goal of this clinical trial is to learn investigate the effect of instrument-assisted early progressive resistance swallowing training on swallowing related muscle strength in critically ill patients. It will also learn about the safety of swallowing training. The main questions it aims to answer are: |
* Does instrument-assisted early progressive resistance swallowing training increase the swallowing related muscle strength in critically ill patients? |
* What medical problems do participants have when taking swallowing training? |
Researchers will compare instrument-assisted early progressive resistance swallowing training to pure effortful swallowing to see if instrument-assisted early progressive resistance swallowing training works to increase muscle strength. |
Participants will: |
-Take instrument-assisted early progressive resistance swallowing training or pure effortful swallowing every day for 2 weeks and take muscle strength test every week. conditions: Swallowing Training on Muscle Strength studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 66 type: ESTIMATED name: pure effortful swallowing name: progressive resistance swallowing training measure: Forced swallowing tongue pressure sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06372782 id: 43CH2305 briefTitle: Comparing Pain, Safety and Effectiveness of Restylane Skinboosters Vital Lido and Vital Without Lido in Dorsal Hand overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2024-08 date: 2024-04-18 date: 2024-04-18 name: Galderma R&D class: INDUSTRY briefSummary: This is a randomized, multi-center, split-hand, subject-blinded study comparing pain, safety and effectiveness of Restylane Skinboosters Vital Lidocaine and Restylane Vital without lidocaine for improving appearance of the dorsal hands in Chinese subjects. conditions: Skin Aging of Dorsal Hands studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 90 type: ESTIMATED name: Restylane Skinboosters Vital Lidocaine name: Restylane Vital measure: The within-subject difference in VAS score (Restylane Skinboosters Vital Lidocaine- Restylane Vital) at end of injection (T0). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Galderma Research Site 01 city: Shanghai state: Shanghai country: China name: Principle Investigator role: CONTACT lat: 31.22222 lon: 121.45806 facility: Galderma Research Site 02 city: Hangzhou state: Zhejiang country: China name: Principle Investigator role: CONTACT lat: 30.29365 lon: 120.16142 facility: Galderma Research Site 03 city: Hangzhou state: Zhejiang country: China lat: 30.29365 lon: 120.16142 hasResults: False |
<|newrecord|> nctId: NCT06372769 id: 20240304 briefTitle: Myoelectric Activity and Mandibular Movement for the Diagnosis of Temporomandibular Disorder overallStatus: COMPLETED date: 2022-02-01 date: 2022-07-15 date: 2023-02-10 date: 2024-04-18 date: 2024-04-18 name: Stomatological Hospital Affiliated with Fujian Medical University class: OTHER briefSummary: This study aimed to provide normal reference values of surface electromyography (sEMG) and mandibular kinematics in Chinese young adults, compare the sex differences and assess the diagnosis value of these indices. conditions: Temporomandibular Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 120 type: ACTUAL name: electromyograph and kinesiograph measure: Surface electromyography (μV) measure: Mandibular kinematics (mm, mm/s) sex: ALL minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: The Affiliated Stomatological Hospital of Fujian Medical University city: Fuzhou state: Fujian zip: 350002 country: China lat: 26.06139 lon: 119.30611 hasResults: False |
<|newrecord|> nctId: NCT06372756 id: 102122 briefTitle: Deep Learning Reconstruction Algorithms in Dual Low-dose CTA overallStatus: RECRUITING date: 2023-06-01 date: 2025-12 date: 2026-03 date: 2024-04-18 date: 2024-04-18 name: Hao Tang class: OTHER briefSummary: The goal of this observational study is to evaluate the impact of deep learning image reconstruction on the image quality and diagnostic performance of double low-dose CTA. The main question it aims to answer is to explore the feasibility of deep learning image reconstruction in double low-dose CTA. conditions: Deep Learning studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1200 type: ESTIMATED name: Deep learning image reconstruction measure: The specificity and sensitivity calculated through the optimal cutoff value of the receiver operating characteristic curve. measure: The signal-to-noise ratio calculated from image CT values and noise sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430000 country: China name: Youfa M Tang role: CONTACT phone: +8613554101223 email: [email protected] lat: 30.58333 lon: 114.26667 hasResults: False |
<|newrecord|> nctId: NCT06372743 id: Alex Hospital briefTitle: Nurse-led Physician-supported Care for Patients With Chronic Kidney Disease and Multimorbidity acronym: INTEGREATCKD overallStatus: RECRUITING date: 2023-11-01 date: 2025-05-31 date: 2026-12-31 date: 2024-04-18 date: 2024-04-18 name: Alexandra Hospital class: OTHER name: National University Hospital, Singapore briefSummary: Chronic kidney disease (CKD) is a prevalent chronic disease and is often intertwined with the management of cardiovascular disease and the optimization of metabolic risk factors. In light of steeply rising rates of end-stage kidney disease (ESKD) and increased healthcare resource utilization by CKD patients, the investigators propose that the role of nurses could be expanded to support the care of CKD patients in the community. |
A total of 220 patients will be randomized (1:1) to the intervention or control groups (usual care). The intervention entails enrolment into a nurse-led, physician-supported programme (INTEGREAT-CKD), comprising outpatient consultations and community-based ambulatory monitoring and counselling primarily driven by CKD-trained advanced practice nurses (APNs) and healthcare professionals conducted over 6 months. Patient-reported outcomes like health-related quality of life (HRQOL), as measured by EQ-5D and KDQOL, CKD self-management score and CKD health literacy will be assessed at baseline and after 6 months. The primary outcome is CKD self-management. Other secondary outcomes to be assessed and tracked including achievement of clinical targets relevant to slowing down CKD progression, attainment of CKD best practice guidelines as specified in the KDIGO CKD Evaluation and Management guidelines 2020. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a dual-centre two-arm, open-label randomized controlled trial (RCT). Patients are randomized with a one-to-one allocation into two parallel groups. primaryPurpose: TREATMENT masking: NONE count: 220 type: ESTIMATED name: INTEGREAT-CKD Intervention measure: Chronic Kidney Disease Self-Management (CKD-SM) Questionnaire measure: Secondary outcome sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wei Zhen Hong status: RECRUITING city: Singapore zip: 119228 country: Singapore name: Wei Zhen Hong role: CONTACT phone: 97330789 email: [email protected] name: Priyanka Khatri, MBBS role: SUB_INVESTIGATOR lat: 1.28967 lon: 103.85007 hasResults: False |
<|newrecord|> nctId: NCT06372730 id: 29BRC23.0161 id: 2023-A01566-39 type: OTHER domain: IDRCB briefTitle: Residual Pulmonary Vascular Obstruction Index Computed With Ventilation/Perfusion SPECT/CT Imaging to Predict the Risk of Venous Thromboembolism Recurrence in Patients With Pulmonary Embolism (PRONOSPECT) acronym: PRONOSPECT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-10 date: 2029-01 date: 2024-04-18 date: 2024-04-18 name: University Hospital, Brest class: OTHER briefSummary: Major risk after pulmonary embolism (PE) is recurrence, fatal in 10% of patients. Patients with PE can be stratified in 3 groups according to the risk of recurrence : very low risk, high risk or Intermediate risk. Little is known about this last group. |
Anticoagulation is efficient to prevent recurrence but is currently not recommended for patient with an intermediate risk of recurrence. |
Identifying risk factors of recurrent PE remains a major issue to identify sub-groups of patients who would require lifelong anticoagulation. |
In 30-40% of cases, PE patients develop residual pulmonary vascular obstruction (RPVO), which has been found to be associated with an increased recurrence risk. This last observation was mostly reported in patients with unprovoked PE (patients with high risk of recurrence) and RPVO was measured using conventional planar lung scan. |
In patients with an intermediate risk of recurrence, the impact of RPVO has been much less studied. In addition, the definition of RPVO was variable according to studies and correlation between RPVO burden and recurrence risk has not been clearly demonstrated. This might be explained by the inherent limitation of RPVO quantification using conventional planar imaging, which is only based on a visual estimation on 2-dimensional images. |
Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT) is a new method of scintigraphic image acquisition that offers the advantage of 3-dimensional imaging, enabling more accurate and reproducible quantification of RPVO. |
The main hypothesis of this study is that in patients with PE at intermediate risk of recurrence, RPVO computed with V/Q SPECT/CT imaging may be an important predictor of recurrence. conditions: Pulmonary Embolism conditions: Venous Thromboembolism studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Cohort study primaryPurpose: PREVENTION masking: NONE count: 665 type: ESTIMATED name: Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT) measure: Symptomatic recurrent venous thromboembolism (VTE), including objectively confirmed nonfatal symptomatic PE or proximal deep vein thrombosis or fatal PE during a 24-month follow-up after inclusion in the study measure: Adjudicated symptomatic objectively confirmed recurrent VTE during the follow-up period. measure: Percentage of patients with RPVO (as defined by a perfusion defect > 5%) on V/Q SPECT/CT imaging at inclusion in the study. measure: Different cut-offs of pulmonary vascular obstruction index will be evaluated to predict the risk of VTE recurrence at 2 years, by generating ROC curves measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: age measure: The following score will be computed : HERDOO2 (Hyperpigmentation, Edema, Redness, D-Dimer, Obesity, Old) measure: Potential predictors of RPVO including : demographics measure: Symptomatic recurrent VTE during a 3 Months follow-up period in patients with suspicion of PE recurrence who has been left untreated based on a negative V/Q SPECT/CT scan measure: Dyspnea index will be assessed using mMRC scale (Modified Medical Research Council) measure: Quality of life (QoL) will be assessed using PEmb-Qol (Pulmonary Embolism Quality of Life) measure: Number of Participants with chronic thromboembolic pulmonary hypertension (CTEPH). measure: Mortality of all causes. measure: Percentage of patients with RPVO (> 5%) on V/Q SPECT/CT imaging using Technegas and Krypton. measure: The following score will be computed : PADIS-PE score. measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: gender measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: obesity measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: D-Dimer measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: inherited or acquired thrombophilia measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: residual vein thrombosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Amiens city: Amiens zip: 80054 country: France name: Marie-Antoinette SEVESTRE, Pr role: CONTACT phone: +33322087306 email: [email protected] lat: 49.9 lon: 2.3 facility: CHU Angers city: Angers zip: 49933 country: France name: Jeanne HERSANT, Pr role: CONTACT phone: +33661392285 email: [email protected] lat: 47.46667 lon: -0.55 facility: CHU Brest city: Brest zip: 29609 country: France name: Pierre-Yves LE ROUX, Pr role: CONTACT phone: +33298223327 email: [email protected] name: Francis COUTURAUD, Pr role: PRINCIPAL_INVESTIGATOR lat: 48.3903 lon: -4.48628 facility: Hôpital Louis MourierAP-HP city: Colombes zip: 92700 country: France name: Isabelle MAHE, Pr role: CONTACT phone: +33147606490 email: [email protected] lat: 48.91882 lon: 2.25404 facility: CHD Vendée - La Roche sur Yon city: La Roche-sur-Yon zip: 85925 country: France name: Jean-Manuel KUBINA, Dr role: CONTACT phone: +33251446301 email: [email protected] lat: 46.66667 lon: -1.43333 facility: Kremlin-Bicêtre AP-HP city: Le Kremlin-Bicêtre zip: 94270 country: France name: David MONTANI, Pr role: CONTACT phone: +33145217976 email: [email protected] lat: 48.81471 lon: 2.36073 facility: CH Les Sables d'Olonne city: Les Sables-d'Olonne zip: 85340 country: France name: Nicolas BREBION role: CONTACT phone: +33251218824 email: [email protected] lat: 46.5 lon: -1.78333 facility: Hegp Ap-Hp city: Paris zip: 75015 country: France lat: 48.85341 lon: 2.3488 facility: CH Quimper city: Quimper zip: 29000 country: France name: Charles ORIONE, Dr role: CONTACT phone: +33298526096 email: [email protected] lat: 48.0 lon: -4.1 facility: CHU St-Etienne city: Saint-Étienne zip: 42055 country: France name: Laurent BERTOLETTI, Pr role: CONTACT phone: +33477127770 email: [email protected] lat: 45.43389 lon: 4.39 facility: CHIC Toulon city: Toulon zip: 83056 country: France name: Jean-Noël POGGI, Dr role: CONTACT phone: +33494145787 email: [email protected] lat: 43.12442 lon: 5.92836 facility: HIA Toulon city: Toulon zip: 83800 country: France name: Antoine-Raphaël BRONSTEIN, Dr role: CONTACT phone: +33483162553 email: [email protected] lat: 43.12442 lon: 5.92836 facility: CHU Toulouse city: Toulouse zip: 31059 country: France name: Alessandra BURA-RIVIERE, Pr role: CONTACT phone: +33561322438 email: [email protected] lat: 43.60426 lon: 1.44367 hasResults: False |
<|newrecord|> nctId: NCT06372717 id: AP30CP01 briefTitle: A Study to Investigate APL-4098 Alone and/or in Combination With Azacitidine in R/R AML and High-Risk MDS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-03-01 date: 2027-04-01 date: 2024-04-18 date: 2024-04-18 name: Apollo Therapeutics Ltd class: INDUSTRY briefSummary: This is an open-label, Phase 1/2 study to determine the safety, tolerability, and efficacy of APL-4098 alone and/or in combination with azacitidine for the treatment of relapsed or refractory (R/R) acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)/AML and MDS-excess blasts (EB). Participants with the MDS-EB subtype will be eligible for the Phase 1 part of the study only. conditions: Acute Myeloid Leukemia Refractory conditions: Myelodysplastic Syndrome Acute Myeloid Leukemia conditions: Myelodysplastic Syndrome With Excess Blasts conditions: Acute Myeloid Leukemia, in Relapse studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 112 type: ESTIMATED name: APL-4098 name: Azacitidine and APL-4098 measure: Incidence of Treatment Emergent Adverse Events [Safety] (Phase 1) measure: Incidence of Dose Limiting Toxicities [Tolerability] (Phase 1) measure: Estimate the Maximum Tolerated Dose (MTD) of APL-4098 alone and/or in combination with azacitidine (Phase 1) measure: Determine Recommended Phase 2 Dose (RP2D) levels of APL-4098 alone and/or in combination with azacitidine (Phase 1) measure: Assess the Pharmacokinetics of APL-4098 alone and/or in combination with azacitidine (Phase 1) measure: Assess the Pharmacokinetics of APL-4098 alone and/or in combination with azacitidine (Phase 1) measure: Assess the Pharmacokinetics of APL-4098 alone and/or in combination with azacitidine (Phase 1) measure: Assess efficacy of APL-4098 alone and/or in combination with azacitidine (Phase 2) measure: Assess response to disease with APL-4098 alone and/or in combination with azacitidine (Phase 1) measure: Duration of response with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2) measure: Time to response with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2) measure: Event Free Survival with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2) measure: Overall Survival with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2) measure: Incidence of Treatment Emergent Adverse Events [Further Safety] (Phase 2) measure: Incidence of Adverse Events leading to discontinuation of APL-4098 [Further Tolerability] (Phase 2) measure: Further assess the PK of APL-4098 alone and/or in combination with azacitidine (Phase 2) measure: Further assess the PK of APL-4098 alone and/or in combination with azacitidine (Phase 2) measure: Further assess the PK of APL-4098 alone and/or in combination with azacitidine (Phase 2) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06372704 id: 2024/72 briefTitle: Is the HIFEM Procedure an Effective Treatment for Men With Post-prostatectomy Incontinence? acronym: HIFEM for PPI overallStatus: COMPLETED date: 2024-02-01 date: 2024-04-01 date: 2024-04-05 date: 2024-04-18 date: 2024-04-24 name: Kirsehir Ahi Evran Universitesi class: OTHER briefSummary: Urinary incontinence after radical prostatectomy surgery is a common condition that negatively affects daily life. Patients often experience discomfort due to urine leakage and the resulting need to use pads daily. This study aimed to evaluate the efficacy and safety of high-intensity focused electromagnetic technology used therapeutically in patients with urinary incontinence after radical prostatectomy. conditions: Prostate Cancer conditions: Incontinence conditions: Pelvic Floor Muscle Weakness studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 27 type: ACTUAL name: HIFEM measure: This study demonstrated the safe and effective use of HIFEM technology to prevent PPI by strengthening the pelvic floor muscles in a variety of patients. sex: MALE minimumAge: 63 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: İbrahim Üntan city: Kirşehi̇r country: Turkey lat: 39.14583 lon: 34.16389 hasResults: False |
<|newrecord|> nctId: NCT06372691 id: PoplitealApproach SciaticBlock briefTitle: How Do We Ultrasound-Guided Popliteal Approach Sciatic Nerve Block? overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-01 date: 2024-09-01 date: 2024-04-18 date: 2024-04-18 name: Ankara City Hospital Bilkent class: OTHER briefSummary: The aim of this prospective, randomized, observer-blind study to compare subparaneural approach injection with interneural approach injection in popliteal sciatic nerve blocks. conditions: Adult conditions: Regional Anesthesia Morbidity conditions: Anesthesia Injection Site studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 809 type: ESTIMATED name: Subparaneural Injection (Grup S), Block name: Interneural Injection (Grup I), Block measure: Onset Time measure: Block Execution Times measure: Need for Multiple Injections Owing to Insufficient Anesthesia measure: Additional Rescue Analgesic measure: Adverse Effects to Anesthesia measure: Hemodynamic Effects Of The Block measure: Effects Of The Block On Heart Rate measure: Effects Of The Block On Peripheral Pulse Oximetry measure: Regression Time Of Sensory and Motor Block measure: Total Block Times sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06372678 id: CM326-102102 briefTitle: Study of CM326 in Participants With Chronic Rhinosinusitis With Nasal Polyposis overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2026-06-30 date: 2026-06-30 date: 2024-04-18 date: 2024-04-18 name: Keymed Biosciences Co.Ltd class: INDUSTRY briefSummary: This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM326, and to observe the Pharmacokinetics, Pharmacodynamics and immumogenicity of CM326 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). conditions: Chronic Rhinosinusitis With Nasal Polyps 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: CM326 name: Placebo measure: Changes from baseline of nasal polyp score (NPS) in eosinophilic chronic rhinosinusitis with nasal polyps (CRSwNP) at week 24. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tongren Hospital, CMU city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06372665 id: CDB-IV-JE-025202301 briefTitle: Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization overallStatus: RECRUITING date: 2024-01-01 date: 2025-03-31 date: 2025-06-30 date: 2024-04-18 date: 2024-04-18 name: Liaoning Chengda Biotechnology CO., LTD class: INDUSTRY briefSummary: This is a single-arm, non-randomized, open-label post-marketing safety observation study. The purpose of this study is to investigate the safety of JEV-I given with primary immunization in a large amount of healthy children aged 8 months and older. conditions: Japanese Encephalitis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 28547 type: ESTIMATED measure: Number of Participants Reporting Solicited Local and Systemic Adverse Events, and Unsolicited Adverse Events sex: ALL minimumAge: 8 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT 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 email: [email protected] name: Zhiguo Wang, Master role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 hasResults: False |
<|newrecord|> nctId: NCT06372652 id: TE-8214-001 briefTitle: A Phase 1 Study of TE-8214 Solution in Healthy Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2024-10-10 date: 2024-12-26 date: 2024-04-18 date: 2024-04-19 name: Immunwork, Inc. class: INDUSTRY briefSummary: This is a Phase 1, first-in-human, randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, and PK of TE-8214 in healthy volunteers. The study will assess single ascending doses (SAD) of TE-8214. conditions: Acromegaly studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 32 type: ESTIMATED name: TE-8214 - SAD name: Placebo measure: Safety and tolerability of TE-8214 by the incidence of treatment-emergent adverse events (TEAEs) measure: Safety and tolerability of TE-8214 by the incidence of treatment-related adverse events measure: Safety and tolerability of TE-8214 by the incidence of injection site reactions (ISRs) measure: Safety and tolerability of TE-8214 by the incidence of clinically significant laboratory findings measure: Safety and tolerability of TE-8214 by the changes in physical examination findings measure: Safety and tolerability of TE-8214 by the changes in ECG findings measure: PK Parameters: Maximum observed concentration (Cmax) measure: PK Parameters: Time to maximum observed concentration (Tmax) measure: PK Parameters: Area under the concentration-time curve (AUC) from time zero to the last measurable concentration (AUC 0-last) sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: CMAX Clinical Research city: Adelaide state: South Australia zip: 5000 country: Australia name: Jessica Gehlert, Dr role: CONTACT lat: -34.92866 lon: 138.59863 hasResults: False |
<|newrecord|> nctId: NCT06372639 id: TAU-PTSD-TMS briefTitle: Characterization and Modulation of Traumatic Memories in PTSD Patients Using TMS overallStatus: RECRUITING date: 2022-02-23 date: 2024-11-24 date: 2024-11-24 date: 2024-04-18 date: 2024-04-18 name: Tel Aviv University class: OTHER briefSummary: Characterization and modulation of traumatic memories in PTSD patients using TMS. conditions: Post Traumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Trans-Cranial Magnetic Stimulation measure: CAPS-5 score measure: Neurological measures of functional connectivity measure: Intrusive memories sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tel Aviv University status: RECRUITING city: Tel Aviv zip: 69978 country: Israel name: Yair Bar-Haim, PhD role: PRINCIPAL_INVESTIGATOR lat: 32.08088 lon: 34.78057 hasResults: False |
<|newrecord|> nctId: NCT06372626 id: ZG005-004 briefTitle: Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma. overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-07 date: 2026-08 date: 2024-04-18 date: 2024-04-18 name: Suzhou Zelgen Biopharmaceuticals Co.,Ltd class: INDUSTRY briefSummary: The trial is divided into two parts. PART 1 is a dose escalation study of the ZG005 combined with Etoposide and Cisplatin, primarily assessing the tolerability and safety of this combined treatment. PART 2 is a dose expansion study, further evaluating the preliminary efficacy and safety of this combined treatment. conditions: Neuroendocrine Carcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 93 type: ESTIMATED name: ZG005 name: Etoposide name: Cisplatin name: Placebo measure: Dose Limiting Toxicity (DLT) measure: Objective Response Rate (ORR) measure: Adverse Event (AE) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese PLA General Hospital city: Beijing state: Beijing zip: 100853 country: China name: Jianming Xu role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06372613 id: LRG&UC briefTitle: Association Between LRG and Endoscopic Remission in Ulcerative Colitis overallStatus: RECRUITING date: 2024-02-25 date: 2024-12-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-18 name: Showa Inan General Hospital class: OTHER briefSummary: We attempt to clarify the serum leucine-rich α 2-glycoprotein (LRG) level which predicts endoscopic remission in ulcerative colitis patients in this study. Colonoscopy with histology is performed when endoscopic remission will be predicted based on serum LRG values, irrespective of symptoms. Serum LRG levels were analyzed by an enzyme-linked immunosorbent assay. conditions: Ulcerative Colitis in Remission studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Endoscopic remission of UC sex: ALL minimumAge: 20 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Showa Inan General Hospital status: RECRUITING city: Komagane country: Japan name: Akira Horiuchi role: CONTACT lat: 35.71657 lon: 137.93745 hasResults: False |
<|newrecord|> nctId: NCT06372600 id: 2023-181 briefTitle: Effect of Extracorporeal Shock Wave Combined With Autologous Platelet-rich Plasma Injection on Rotator Cuff Calcific Tendinitis overallStatus: NOT_YET_RECRUITING date: 2025-06-01 date: 2025-12-31 date: 2026-02-20 date: 2024-04-18 date: 2024-04-18 name: Xiali Xue class: OTHER briefSummary: The purpose of this study is to explore the effect of extracorporeal shock wave combined with autologous platelet-rich plasma injection on the rehabilitation of rotator cuff calcific tendinitis, to provide new treatment methods and evidence for the rehabilitation of rotator cuff calcific tendinitis, and to reduce patients; pain and return to normal life as soon as possible. conditions: Rotator Cuff Tendinitis conditions: Rotator Cuff Tendinosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Extracorporeal shock wave therapy device name: Platelet-rich plasma measure: Visual Analogue Scale,VAS measure: American Shoulder and Elbow Surgeon's Form,ASES measure: the university of California at Los Angeles shoulder rating scale, UCLA measure: The location and size of the calcifications were examined by ultrasound sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06372587 id: 5502 briefTitle: Next-Generation alzheImer'S Therapeutics acronym: ENERGISE overallStatus: RECRUITING date: 2023-12-19 date: 2024-12-30 date: 2027-02-28 date: 2024-04-18 date: 2024-04-18 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Is this the right time to use next-generation approaches in Alzheimer's disease (AD)? In recent years, several large clinical trials testing treatments for AD have failed, putting the entire field on a reset. AD drug trials have almost exclusively sought to use antibodies targeted toward misfolded amyloid and tau proteins. Of note, although these approaches have failed, they were designed to cover both familial and sporadic forms of AD. On the other hand, the failure in developing new effective drugs is attributed to, but not limited to, the highly heterogeneous nature of AD with multiple underlying hypotheses and multifactorial pathology. The idea underlying this project is based on the assumption that learning and memory disorders can arise when the connections between neurons do not change appropriately in response to experience. Thus, by intervening on the core mechanisms of the cellular correlate of learning and memory, i.e., synaptic plasticity, the investigators expect to preserve some of the essential brain functions in AD. By overcoming the limits of traditional AD therapeutic approaches, the investigators will use genetically encoded engineered proteins (GEEPs), which the investigators developed and tested in vitro and in murine models, to control their activity in living human neurons boosting synaptic plasticity. Indeed, outstanding and relevant progress in understanding synaptic physiology empowers the possibility to prevent or limit brain disease like never before. The investigators designed GEEPs to address some of the leading causes of synaptic plasticity failures documented in AD. Thus, GEEPs will be tested in human induced pluripotent stem cells (hiPSCs)-derived living neurons obtained from reprogrammed peripheral tissues of participants with Alzheimer's diseases. hiPSCs will be obtained from fibroblast-derived from a skin biopsy of participants with AD and controls performed in local anesthesia using a 4 mm punch. The findings will provide the first preclinical study on the effect of genetically engineered proteins to control essential pathways implicated in synaptic plasticity on AD-related cognitive decline. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 14 type: ESTIMATED name: genetically encoded engineered proteins measure: To use genetically encoded engineered proteins to obtain an inducible control of their activity in living human neurons preventing dendritic spines loss measure: To leverage genetically encoded engineered proteins to prevent alterations in the morphology of dendritic spines in living human neurons measure: To use genetically encoded engineered proteins to obtain an inducible control of their activity in living human neurons promoting functional synaptic plasticity measure: To use genetically encoded engineered proteins to obtain evaluate neuronal excitability in living human neurons sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS status: RECRUITING city: Roma zip: 00168 country: Italy name: CRISTIAN RIPOLI role: CONTACT phone: +390630154966 email: [email protected] name: CRISTIAN RIPOLI role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False |
<|newrecord|> nctId: NCT06372574 id: GO44669 briefTitle: A Study of RO7617991 in Patients With Locally Advanced or Metastatic MAGE-A4-Positive Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2028-02-01 date: 2028-02-01 date: 2024-04-18 date: 2024-04-18 name: Genentech, Inc. class: INDUSTRY briefSummary: This study will evaluate the safety, tolerability, and pharmacokinetics of RO7617991, and will make a preliminary assessment of the anti-tumor activity of RO7617991 in human leukocyte antigen (HLA)-A\*02 eligible patients with locally advanced or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive solid tumors. conditions: Refractory Cancer conditions: Recurrent Cancer conditions: Solid Tumor, Adult studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 210 type: ESTIMATED name: RO7617991 name: Tocilizumab measure: Incidence and Severity of Adverse Events measure: Number of Participants with Abnormal Values in Targeted Vital Signs measure: Number of Participants with Abnormal Values in Clinical Laboratory Test Parameters measure: Serum Concentration of RO7617991 at Specific Timepoints measure: Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1 measure: Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1 measure: Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1 measure: Overall Survival (OS) measure: Prevalence of Anti-Drug Antibodies (ADAs) to RO7617991 at Baseline and Incidence of ADAs to RO7617991 During the Study sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06372561 id: Melatonin- vital pulp therapy briefTitle: Comparative Evaluation of Melatonin Versus MTA on Vital Pulp Therapy in Young Permanent First Molars: An in Vivo Study overallStatus: RECRUITING date: 2023-05-20 date: 2024-05-20 date: 2024-06-20 date: 2024-04-18 date: 2024-04-18 name: Suez Canal University class: OTHER briefSummary: The process of dental caries is dynamic and can be either reversible or irreversible depending on the balance between protective and pathologic factors in the oral cavity. Untreated dental caries causes pulpal injury, inflammation, and necrosis. Melatonin plays an essential role in the regulation of bone growth. The actions that melatonin exerts on odontoblasts may be similar to its action on osteoblasts. conditions: Dental Caries in Children conditions: Vital Pulp Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 45 type: ESTIMATED name: Mineral trioxide aggregate (dressing material) name: Melatonin (dressing material) measure: Clinically assessment (Modified visual analogue scale) measure: Clinically assessment (Millar's index) measure: Clinically assessment (presence or abscence) measure: Radiographic assessment (using Image J software program) measure: Radiographic assessment (using Image J software program) measure: Radiographic assessment (using Image J software program) measure: Radiographic assessment (using Image J software program) measure: Radiographic assessment (using Image J software program) sex: ALL minimumAge: 6 Years maximumAge: 8 Years stdAges: CHILD facility: Faculty of Medicine, Suez canal university status: RECRUITING city: Ismailia zip: 41522 country: Egypt name: Ismail Dahshan, PHD role: CONTACT phone: 01012715799 email: [email protected] lat: 30.60427 lon: 32.27225 hasResults: False |
<|newrecord|> nctId: NCT06372548 id: NEADS0004 briefTitle: Rehabilitation Training Games for Children With Amblyopia overallStatus: RECRUITING date: 2023-03-01 date: 2024-06-01 date: 2024-08-01 date: 2024-04-18 date: 2024-04-18 name: Zhu Dian class: OTHER briefSummary: A gamification product was developed to guide children with amblyopia to develop rehabilitation training habits by combining cognitive evaluation theory and occlusion therapy. A randomized controlled trial was conducted to examine the ease of use, acceptability and treatment compliance of the game. conditions: Amblyopia conditions: Amblyopia Occlusion conditions: Child Behavior conditions: Adherence, Treatment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 34 type: ESTIMATED name: Find You! Cure My Animal Friends name: DuoBao Vision Training System measure: 8-Item Morisky Medication Adherence Scale (MMAS-8): measure: User Experience Questionnaire (UEQ) sex: ALL minimumAge: 7 Years maximumAge: 10 Years stdAges: CHILD facility: Shanghai Jiao Tong University status: RECRUITING city: Shanghai state: Shanghai zip: 200240 country: China name: Zhao Liu role: CONTACT phone: +8618901626266 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06372535 id: FujianUTCM-1 briefTitle: Effects of Tai Chi Chuan With Different Doses on Cognitive Function in Elderly Patients With Mild Cognitive Impairment overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-15 date: 2025-09-30 date: 2024-04-18 date: 2024-04-18 name: Lidian Chen class: OTHER name: Peking University Third Hospital briefSummary: To determine the impact of Tai Chi Chuan with different exercise volume on cognitive function in elderly patients with mild cognitive impairment. conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 540 type: ESTIMATED name: Tai Chi Chuan （dose 1） name: Tai Chi Chuan （dose 2） name: Tai Chi Chuan （dose 3） name: Tai Chi Chuan （dose 4） name: Tai Chi Chuan （dose 5） name: Tai Chi Chuan （dose 6） name: Tai Chi Chuan （dose 7） name: Tai Chi Chuan （dose 8） name: Tai Chi Chuan （dose 9） measure: Montreal Cognitive Assessment measure: Montreal Cognitive Assessment measure: Wechsler Memory Scale measure: Digital Symbol test measure: Trial Making Test part B measure: Stroop color word test measure: Boston naming test measure: Rey-Osterrieth complex graphics test measure: Rey Auditory Verbal Learning Test measure: Blood glucose metabolism index measure: Blood lipid metabolism index measure: Functional Magnetic Resonance Imaging measure: Electroencephalogram measure: Heart rate variability measure: Gut microflora measure: Sleep Quality measure: General health sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06372522 id: RMB-0517-23 briefTitle: Oxytocin in Multiparous Women overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2027-04 date: 2024-04-18 date: 2024-04-18 name: Rambam Health Care Campus class: OTHER briefSummary: This is a randomized controlled trial investigating whether continuous oxytocin infusion in multiparous women shortens time to delivery, without altering maternal or neonatal outcomes, in augmented deliveries, compared to intermittent infusion. conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 166 type: ESTIMATED name: Pitocin Injectable Product measure: The rate of women delivering within 24 hours. measure: Length of latent and active phases of labor. measure: The rate of instrumental and caesarean deliveries. measure: chorioamnionitis measure: obstetric anal sphincter injuries (OASIS) measure: hyponatremia measure: post-partum hemorrhage (PPH) measure: neonatal outcome - 1 and 5-minute Apgar score measure: umbilical artery pH measure: NICU admission measure: Women's satisfaction. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06372509 id: L2-070 briefTitle: A Proteomic Analysis for Understanding the Link Between Migraine and Cardiovascular Disease acronym: PMCD overallStatus: RECRUITING date: 2024-04-03 date: 2025-10-30 date: 2025-10-30 date: 2024-04-18 date: 2024-04-18 name: Centro Cardiologico Monzino class: OTHER name: IRCCS Policlinico S. Donato briefSummary: This is a multicenter, prospective observational study. Will be collecting data from 90 consecutive patients (aged 25- 60 years ) with and without migraine admitted at our Hospital. Primary aim of the study will be to assess the correlation between migraine and proteomic profiling of plasma and their possible correlation with known cardio and cerebrovascular disease and CV risk factors. conditions: Coronary Artery Disease conditions: Migraine conditions: Cardiovascular Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 90 type: ESTIMATED measure: Correlation between migraine and proteomic profiling of plasma sex: ALL minimumAge: 25 Years maximumAge: 60 Years stdAges: ADULT facility: Centro Cardiologico Monzino status: RECRUITING city: Milano state: Milan zip: 20131 country: Italy name: Daniela Trabattoni, MD role: CONTACT phone: 0258002780 email: [email protected] lat: 45.46427 lon: 9.18951 hasResults: False |
<|newrecord|> nctId: NCT06372496 id: 219912 briefTitle: Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma overallStatus: NOT_YET_RECRUITING date: 2024-04-16 date: 2026-03-11 date: 2026-03-11 date: 2024-04-18 date: 2024-04-18 name: GlaxoSmithKline class: INDUSTRY briefSummary: The goal of this study is to assess and compare the effectiveness of fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) with inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA) in adult participants with uncontrolled asthma conditions: Asthma studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1136 type: ESTIMATED name: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate name: Inhaled corticosteroids/long-acting beta-2 agonists measure: Change from baseline in trough forced expiratory volume in 1 second (FEV1) measure: Number of participants achieving ≥0.5 point improvement from baseline for the Asthma Control Questionnaire-7 (ACQ-7) after 24 weeks of treatment measure: Number of participants achieving the composite endpoint at Week in participants after 52 weeks of treatment measure: Change from baseline in trough forced expiratory volume in 1 second (FEV1) after 52 weeks of treatment measure: Number of participants achieving ≥0.5 point improvement from baseline for the ACQ-7 after 52 weeks of treatment measure: Number of participants achieving ≥0.5 point improvement from baseline for the Asthma Control Questionnaire-6 (ACQ-6) after 24 and 52 weeks of treatment measure: Number of participants achieving ≥0.5 point improvement from baseline for the ACQ-5 after 24 and 52 weeks of treatment measure: Change from baseline in the ACQ-7 total score after 24 and 52 weeks of treatment measure: Change from baseline in the ACQ-5 total score after 24 and 52 weeks of treatment measure: Change from baseline in the ACQ-6 total score after 24 and 52 weeks of treatment measure: Change from baseline in the Asthma Control Test (ACT) score after 24 and 52 weeks of treatment measure: Number of participants achieving the composite endpoint among those on budesonide/formoterol prior to randomization measure: Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) total scores after 24 and 52 weeks of treatment measure: Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) domain scores after 24 and 52 weeks of treatment measure: Change from baseline in the four domains of the asthma-specific adaptation of the Work Productivity and Activity Impairment Questionnaire (WPAI:Asthma) after 24 and 52 weeks of treatment measure: Change from baseline in trough forced expiratory volume in 1 second (FEV1) among participants on budesonide/formoterol prior to randomization measure: Number of participants achieving ≥0.5 points improvement from baseline for ACQ-7 among participants on budesonide/formoterol prior to randomization measure: Change from baseline in the ACQ-7 total score among participants on budesonide/formoterol prior to randomization measure: Change from baseline in trough forced expiratory volume in 1 second (FEV1) for participants with no treatment prior to randomization. measure: Number of participants achieving ≥0.5 points improvement from baseline for ACQ-7 for participants with no treatment prior to randomization. measure: Change from baseline in the ACQ-7 total score for participants with no treatment prior to randomization. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GSK Investigational Site city: Little Rock state: Arkansas zip: 72205 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Karl V Sitz role: PRINCIPAL_INVESTIGATOR lat: 34.74648 lon: -92.28959 facility: GSK Investigational Site city: Newport Beach state: California zip: 92663 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Ryan Mitchell Klein role: PRINCIPAL_INVESTIGATOR lat: 33.61891 lon: -117.92895 facility: GSK Investigational Site city: Miami state: Florida zip: 33135 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Enrique Villa role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: GSK Investigational Site city: Miami state: Florida zip: 33173 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Ileana C. Rodicio role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: GSK Investigational Site city: Miami state: Florida zip: 33173 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Jaime Landman role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: GSK Investigational Site city: Orlando state: Florida zip: 32819 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Marvin Heuer role: PRINCIPAL_INVESTIGATOR lat: 28.53834 lon: -81.37924 facility: GSK Investigational Site city: Port Charlotte state: Florida zip: 33952 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Joseph Ravid role: PRINCIPAL_INVESTIGATOR lat: 26.97617 lon: -82.09064 facility: GSK Investigational Site city: Tallahassee state: Florida zip: 32308 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Ronald H. Saff role: PRINCIPAL_INVESTIGATOR lat: 30.43826 lon: -84.28073 facility: GSK Investigational Site city: Columbus state: Georgia zip: 31904 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Robert R Chrzanowski role: PRINCIPAL_INVESTIGATOR lat: 32.46098 lon: -84.98771 facility: GSK Investigational Site city: Normal state: Illinois zip: 61761 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Dareen Siri role: PRINCIPAL_INVESTIGATOR lat: 40.5142 lon: -88.99063 facility: GSK Investigational Site city: Bangor state: Maine zip: 04401 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Paul Alan Shapero role: PRINCIPAL_INVESTIGATOR lat: 44.80118 lon: -68.77781 facility: GSK Investigational Site city: Columbia state: Maryland zip: 21044 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: David Nyanjom role: PRINCIPAL_INVESTIGATOR lat: 39.24038 lon: -76.83942 facility: GSK Investigational Site city: Brick state: New Jersey zip: 08724 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Bruce DeCotiis role: PRINCIPAL_INVESTIGATOR lat: 40.05928 lon: -74.13708 facility: GSK Investigational Site city: Linwood state: New Jersey zip: 08221 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Allen Silvey role: PRINCIPAL_INVESTIGATOR lat: 39.33984 lon: -74.57516 facility: GSK Investigational Site city: New Windsor state: New York zip: 12553 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Sashi Makam role: PRINCIPAL_INVESTIGATOR lat: 41.47676 lon: -74.02375 facility: GSK Investigational Site city: Asheville state: North Carolina zip: 28801 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: David Cypcar role: PRINCIPAL_INVESTIGATOR lat: 35.60095 lon: -82.55402 facility: GSK Investigational Site city: Charlotte state: North Carolina zip: 28273 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Emeka M Eziri role: PRINCIPAL_INVESTIGATOR lat: 35.22709 lon: -80.84313 facility: GSK Investigational Site city: Greenville state: North Carolina zip: 27834 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Bryan Dunn role: PRINCIPAL_INVESTIGATOR lat: 35.61266 lon: -77.36635 facility: GSK Investigational Site city: Raleigh state: North Carolina zip: 27607 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Craig F LaForce role: PRINCIPAL_INVESTIGATOR lat: 35.7721 lon: -78.63861 facility: GSK Investigational Site city: Winston-Salem state: North Carolina zip: 27104 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Wendy C Moore role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 facility: GSK Investigational Site city: Cincinnati state: Ohio zip: 45231 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: David I Bernstein role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 facility: GSK Investigational Site city: Philadelphia state: Pennsylvania zip: 19107 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Sadia Benzaquen role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: GSK Investigational Site city: Philadelphia state: Pennsylvania zip: 19140 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Kartik Shenoy role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: GSK Investigational Site city: Pittsburgh state: Pennsylvania zip: 15241 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Michael J. Palumbo role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 facility: GSK Investigational Site city: Rock Hill state: South Carolina zip: 29732 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Michael Denenberg role: PRINCIPAL_INVESTIGATOR lat: 34.92487 lon: -81.02508 facility: GSK Investigational Site city: Spartanburg state: South Carolina zip: 29303 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Farhan Siddiqui role: PRINCIPAL_INVESTIGATOR lat: 34.94957 lon: -81.93205 facility: GSK Investigational Site city: Dallas state: Texas zip: 75246 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Mark W Millard role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: GSK Investigational Site city: Kerrville state: Texas zip: 78028 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Dale E Mohar role: PRINCIPAL_INVESTIGATOR lat: 30.04743 lon: -99.14032 facility: GSK Investigational Site city: Waco state: Texas zip: 76712 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Niran J. Amar role: PRINCIPAL_INVESTIGATOR lat: 31.54933 lon: -97.14667 facility: GSK Investigational Site city: Ciudad Autónoma de Buenos Aires state: Buenos Aires zip: C1192AAW country: Argentina name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Ana Maria Stok role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: GSK Investigational Site city: Florencio Varela state: Buenos Aires zip: 1888 country: Argentina name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Andrea Cintia Medina role: PRINCIPAL_INVESTIGATOR lat: -34.82722 lon: -58.39556 facility: GSK Investigational Site city: Mar del Plata state: Buenos Aires zip: 7600 country: Argentina name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Luis Wehbe role: PRINCIPAL_INVESTIGATOR lat: -38.00228 lon: -57.55754 facility: GSK Investigational Site city: Cordoba state: Córdova zip: X5003DCE country: Argentina name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Victor Hugo Cambursano role: PRINCIPAL_INVESTIGATOR lat: -31.4135 lon: -64.18105 facility: GSK Investigational Site city: Rosario state: Santa Fe zip: 2000 country: Argentina name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Adriana M. Marcipar role: PRINCIPAL_INVESTIGATOR lat: -32.94682 lon: -60.63932 facility: GSK Investigational Site city: Rosario state: Santa Fe zip: S2000DBS country: Argentina name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Ledit R F Ardusso role: PRINCIPAL_INVESTIGATOR lat: -32.94682 lon: -60.63932 facility: GSK Investigational Site city: Ciudad Autonoma de Buenos Aires zip: C1425BEN country: Argentina name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Anahi Yanez role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: GSK Investigational Site city: Mendoza zip: 5500 country: Argentina name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Pablo Saez Scherbovsky role: PRINCIPAL_INVESTIGATOR lat: -32.89084 lon: -68.82717 facility: GSK Investigational Site city: Rosario zip: 2000 country: Argentina name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Gabriel Gattolin role: PRINCIPAL_INVESTIGATOR lat: -32.94682 lon: -60.63932 facility: GSK Investigational Site city: Bruce state: Australian Capital Territory zip: 2617 country: Australia name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Amber Leah role: PRINCIPAL_INVESTIGATOR lat: -32.46667 lon: 138.2 facility: GSK Investigational Site city: Blacktown state: New South Wales zip: 2148 country: Australia name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Rahul Mohan role: PRINCIPAL_INVESTIGATOR lat: -33.76667 lon: 150.91667 facility: GSK Investigational Site city: Campbelltown state: New South Wales zip: 2560 country: Australia name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Belinda Cochrane role: PRINCIPAL_INVESTIGATOR lat: -34.06667 lon: 150.81667 facility: GSK Investigational Site city: Coffs Harbour state: New South Wales zip: 2450 country: Australia name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Olga O Voloshyna role: PRINCIPAL_INVESTIGATOR lat: -30.29626 lon: 153.11351 facility: GSK Investigational Site city: Kanwal state: New South Wales zip: 2259 country: Australia name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Dominic Douglas role: PRINCIPAL_INVESTIGATOR lat: -33.253 lon: 151.4911 facility: GSK Investigational Site city: Brisbane state: Queensland zip: 4006 country: Australia name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Esmond Leong role: PRINCIPAL_INVESTIGATOR lat: -27.46794 lon: 153.02809 facility: GSK Investigational Site city: Spearwood state: Western Australia zip: 6163 country: Australia name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Peter R Bremner role: PRINCIPAL_INVESTIGATOR lat: -32.10534 lon: 115.77797 facility: GSK Investigational Site city: Brampton state: Ontario zip: L6T 0G1 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Naresh K. Aggarwal role: PRINCIPAL_INVESTIGATOR lat: 43.68341 lon: -79.76633 facility: GSK Investigational Site city: Windsor state: Ontario zip: N8X 1T3 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Syed Anees role: PRINCIPAL_INVESTIGATOR lat: 42.30008 lon: -83.01654 facility: GSK Investigational Site city: Trois-Rivieres state: Quebec zip: G9A 4P3 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Patrice Gauthier role: PRINCIPAL_INVESTIGATOR lat: 46.34515 lon: -72.5477 facility: GSK Investigational Site city: Saskatoon state: Saskatchewan zip: S7N OW8 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Erika Dianne Penz role: PRINCIPAL_INVESTIGATOR lat: 52.13238 lon: -106.66892 facility: GSK Investigational Site city: Fukuoka zip: 802-0083 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Shinichi Osaki role: PRINCIPAL_INVESTIGATOR lat: 33.6 lon: 130.41667 facility: GSK Investigational Site city: Fukuoka zip: 816-0813 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Yuji Kawarada role: PRINCIPAL_INVESTIGATOR lat: 33.6 lon: 130.41667 facility: GSK Investigational Site city: Gifu zip: 509-6134 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Hiroyuki Ohbayashi role: PRINCIPAL_INVESTIGATOR lat: 35.42291 lon: 136.76039 facility: GSK Investigational Site city: Hiroshima zip: 730-0853 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Yoshinori Haruta role: PRINCIPAL_INVESTIGATOR lat: 34.4 lon: 132.45 facility: GSK Investigational Site city: Hyogo zip: 651-0053 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Hiroki Kawabata role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site city: Kagawa zip: 761-8073 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Tadashi Kamei role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site city: Miyazaki zip: 880-2112 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Rei Fujiki role: PRINCIPAL_INVESTIGATOR lat: 31.91667 lon: 131.41667 facility: GSK Investigational Site city: Miyazaki zip: 889-4304 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Kenjiro Nagai role: PRINCIPAL_INVESTIGATOR lat: 31.91667 lon: 131.41667 facility: GSK Investigational Site city: Niigata zip: 950-0088 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Yuki Nishiyama role: PRINCIPAL_INVESTIGATOR lat: 37.88637 lon: 139.00589 facility: GSK Investigational Site city: Tokyo zip: 105-0001 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Akira Mizoo role: PRINCIPAL_INVESTIGATOR lat: 35.6895 lon: 139.69171 facility: GSK Investigational Site city: Tokyo zip: 157-0066 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Akiyoshi Sasamoto role: PRINCIPAL_INVESTIGATOR lat: 35.6895 lon: 139.69171 facility: GSK Investigational Site city: Tokyo zip: 160-0017 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Takahiro Yokoyama role: PRINCIPAL_INVESTIGATOR lat: 35.6895 lon: 139.69171 facility: GSK Investigational Site city: Daegu zip: 41404 country: Korea, Republic of name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Han-Ki Park role: PRINCIPAL_INVESTIGATOR lat: 35.87028 lon: 128.59111 facility: GSK Investigational Site city: Seoul zip: 02841 country: Korea, Republic of name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Byung-Keun Kim role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: GSK Investigational Site city: Seoul zip: 03080 country: Korea, Republic of name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Hye-Ryun Kang role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: GSK Investigational Site city: Seoul zip: 07061 country: Korea, Republic of name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Min-Suk Yang role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: GSK Investigational Site city: Seoul zip: 133-792 country: Korea, Republic of name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Sang-Heon Kim role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: GSK Investigational Site city: Kaohsiung zip: 807 country: Taiwan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Chau-Chyun Sheu role: PRINCIPAL_INVESTIGATOR lat: 22.61626 lon: 120.31333 facility: GSK Investigational Site city: Taichung zip: 40447 country: Taiwan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Chia-Hung Chen role: PRINCIPAL_INVESTIGATOR lat: 24.1469 lon: 120.6839 facility: GSK Investigational Site city: Taichung zip: 407219 country: Taiwan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Pin-Kuei Fu role: PRINCIPAL_INVESTIGATOR lat: 24.1469 lon: 120.6839 hasResults: False |
<|newrecord|> nctId: NCT06372483 id: VMX-C001-03 id: 2023-507059-32-00 type: CTIS briefTitle: Single Dose Trial of VMX-C001 in Healthy Subjects With and Without FXa Direct Oral Anticoagulant overallStatus: RECRUITING date: 2024-02-21 date: 2024-09 date: 2024-09 date: 2024-04-18 date: 2024-04-18 name: VarmX B.V. class: INDUSTRY briefSummary: A single centre, double-blind, randomized, placebo-controlled single dose study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VMX-C001, conducted in two parts: |
Part 1: Single dose of VMX-C001 or placebo in healthy volunteers. |
Part 2: Single dose of VMX-C001 or placebo in combination with a selected factor 10a (FXa) direct oral anticoagulant (DOAC) in healthy older subjects. conditions: Coagulation Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Placebo controlled, single dose. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: VMX-C001 name: Placebo name: Rivaroxaban 20 mg Oral Tablet name: Apixaban 5 mg Oral Tablet name: Edoxaban 60 mg Oral Tablet measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 1) measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 2) measure: PK of VMX-C001 in plasma - Cmax measure: PK of VMX-C001 in plasma - tmax measure: PK of VMX-C001 in plasma - t1/2 measure: PK of VMX-C001 in plasma - AUC0-last measure: PK of VMX-C001 in plasma - AUC0-inf measure: PK of VMX-C001 in plasma - Lambda z measure: PK of VMX-C001 in plasma - CL measure: PK of VMX-C001 in plasma - Vz measure: DOAC plasma concentrations (Part 2) measure: Change in Prothrombin time (PT) following dosing with VMX-C001 measure: Change in activated partial thromboplastin time (aPTT) following dosing with VMX-C001 measure: Change in D-dimer following dosing with VMX-C001 measure: Change in prothrombin fragments F1 and 2 following dosing with VMX-C001 measure: Change in thrombin generation, measured by lag time, following dosing with VMX-C001 measure: Change in thrombin generation, measured by endogenous thrombin potential, following dosing with VMX-C001 measure: Change in thrombin generation, measured by peak height, following dosing with VMX-C001 measure: Change in thrombin generation, measured by time to peak, following dosing with VMX-C001 measure: Change in thrombin generation, measured by velocity index, following dosing with VMX-C001 measure: Change in thrombin generation, measured by time to tail, following dosing with VMX-C001 measure: Change in diluted prothrombin time (dPT) following dosing with VMX-C001 measure: Change in diluted Russell Viper Venom time (dRVVT) following dosing with VMX-C001 measure: Change in real time activated clotting time (ACT) following dosing with VMX-C001 measure: Antibodies against VMX-C001 in plasma measure: Antibodies against human coagulation FX in plasma sex: ALL minimumAge: 18 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ICON status: RECRUITING city: Groningen zip: 9728 NZ country: Netherlands name: Salah Hadi, MD role: CONTACT phone: +31 50 8505 798 email: [email protected] lat: 53.21917 lon: 6.56667 hasResults: False |
<|newrecord|> nctId: NCT06372470 id: CLM-HTN-005 briefTitle: Personalised Dose Optimisation of Zestril Supported by the Digital Blood Pressure Diary in a Primary Care Environment in England: Pragmatic Observational Pilot Study for Remote Hypertension Treatment acronym: OptiZest overallStatus: RECRUITING date: 2024-04-15 date: 2024-08-31 date: 2024-08-31 date: 2024-04-18 date: 2024-04-23 name: Closed Loop Medicine class: INDUSTRY name: Pharmanovia briefSummary: A pragmatic observational proof-of-concept study which aims to determine the feasibility of a remote titration clinic, assisted by home blood pressure monitoring and digital solutions, and assess its impact on real-world outcomes. By incorporating home blood pressure monitoring, the study seeks to offer a promising solution for personalised drug titration and self-management, potentially enhancing patient outcomes while optimising Zestril utilisation conditions: Uncomplicated Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Zestril measure: Achieving target Home Blood Pressure measure: Reduction in systolic blood pressure (SBP) measure: Reduction in diastolic blood pressure (DBP) measure: The time to achieve BP Control (BPC) measure: Patient daily adherence to prescribed medication measure: Adherence to collecting data using the electronic BP diary measure: Patients' thoughts and feelings about BP/treatment measure: Discontinuation of Zestril due to unwanted side effects measure: Number and type of spontaneously reported unwanted side effects measure: User experience and feasibility of the blood pressure digital diary sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Norwich Health Centre status: RECRUITING city: Norwich country: United Kingdom name: Serge Engamba, MD role: CONTACT phone: 01603987074 email: [email protected] name: Marc Buckingham role: CONTACT email: [email protected] lat: 52.62783 lon: 1.29834 hasResults: False |
<|newrecord|> nctId: NCT06372457 id: CV027-1107 briefTitle: COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) acronym: COLLIGO-HCM overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-01 date: 2025-03-01 date: 2025-06-15 date: 2024-04-18 date: 2024-04-18 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: COLLIGO-HCM is a global observational study that will conduct observational research of hypertrophic cardiomyopathy (HCM) treatment in real-world clinical practice. conditions: Hypertrophic Cardiomyopathy (HCM) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 500 type: ESTIMATED name: Approved Hypertrophic Cardiomyopathy drug treatments name: Mavacamten measure: Participant age at Hypertrophic Cardiomyopathy (HCM) diagnosis measure: Participant age at mavacamten treatment initiation measure: Participant sex measure: Participant race/ethnicity measure: Participant insurance coverage measure: Participant employment status measure: Participant educational level measure: Date of Hypertrophic Cardiomyopathy (HCM) diagnosis measure: Participant body mass index (BMI) at Hypertrophic Cardiomyopathy (HCM) diagnosis measure: Hypertrophic Cardiomyopathy (HCM) subtype at diagnosis measure: Participant echocardiogram (ECHO) parameters at Hypertrophic Cardiomyopathy (HCM) diagnosis measure: Participant New York Heart Association (NYHA) class measure: Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis measure: Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis measure: Participant height measure: Participant weight measure: Participant blood pressure measure: Participant heart rate measure: Participant Hypertrophic Cardiomyopathy (HCM) symptoms measure: European participant CYP2C19 genotype measure: Participant family history of Hypertrophic Cardiomyopathy (HCM) measure: Participant family history of obstructive Hypertrophic Cardiomyopathy o(HCM) measure: Participant family history of sudden cardiac death (SCD) measure: Participant smoking status measure: Participant alcohol use measure: Participant recreational drug use measure: Participant involvement in a Hypertrophy Cardiomyopathy (HCM) randomized clinical trial (RCT) measure: Participant cardiovascular (CV) and CV-related comorbidities measure: Participant non-cardiovascular (CV)-related comorbidities measure: Participant electrocardiogram (ECG) rhythm results measure: Participant cardiac magnetic resonance imaging (MRI) results measure: Participant N-terminal pro-B-type natriuretic peptide (NT-proBNP) results measure: Participant cardiac troponin results measure: Participant cardiopulmonary exercise test (CPET) results measure: Participant cardiac monitoring results measure: Participant exercise test results measure: Participant blood creatine levels measure: Participant cardiovascular (CV) events measure: Type of procedures received by participants measure: Cardiovascular treatments prescribed to participants measure: Date of mavacamten prescription measure: Date of mavacamten treatment initiation measure: Date of mavacamten dosage change measure: Reason for mavacamten dosage change measure: Occurrence of mavacamten stable dose (a period of 6-months with the same dose) measure: Dates of follow-up after mavacamten treatment initiation measure: Date of mavacamten treatment interuption or discontinuation measure: Reason for mavacamten treatment interuption or discontinuation measure: Supportive care provided to participants measure: Heath care resource utilization (HCRU) measure: Hypertrophic Cardiomyopathy (HCM) symptom improvement post mavacamten treatment initiation measure: Participant obstructive Hypertrophic Cardiomyopathy (oHCM) symptoms measure: Participant family history of Hypertrophic Cardiomyopathy (HCM) or obstructive Hypertrophic Cardiomyopathy (oHCM) measure: Participant family history of sudden cardiac death (SCD) measure: Cardiovascular (CV) and CV-related comorbidities measure: Non-cardiovascular (non-CV) comorbidities measure: Participant electrocardiogram (ECG) rhythm results measure: Participant echocardiogram (ECHO) results measure: Participant cardiac MRI results measure: Participant NT-proBNP results measure: Participant cardiac tropin results measure: Participant cardiopulmonary exercise test (CPET) results measure: Participant cardiac monitoring results measure: Participant exercise test results measure: Hypertrophic Cardiomyopathy (HCM) subtype measure: Participant symptoms at Hypertrophic Cardiomyopathy (HCM) measure: Participant New York Heart Association (NYHA) class measure: Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis measure: Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IQVIA city: Durham state: North Carolina zip: 27703 country: United States lat: 35.99403 lon: -78.89862 hasResults: False |
<|newrecord|> nctId: NCT06372444 id: 995725 briefTitle: Mechanisms of Acute Kidney Injury in Severe Infections acronym: PET-AKI overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-03 date: 2026-06-30 date: 2024-04-18 date: 2024-04-19 name: Uppsala University Hospital class: OTHER briefSummary: Renal perfusion and neutrophil-mediated inflammation will be assessed in the kidney in sepsis patients with acute kidney injury using positron emission tomography. For marked water will be used for renal perfusion and a newly developed PET tracer molecule (11C-GW457427) with specific binding to neutrophil elastase which provides a measure of the amount of infiltrating neutrophils in the renal parenchyma for inflammation. The study is performed in a PET-CT camera where anatomical imaging takes place at the same time as the PET examinations. conditions: Sepsis conditions: AKI - Acute Kidney Injury conditions: Positron Emission Tomography (PET) studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 15 type: ESTIMATED name: Positron emission tomography (PET) measure: Renal perfusion in patients with sepsis and acute kidney injury (AKI) measured by 15O-labeled water in dynamic positron emission tomography (PET) measure: Presence of neutrophil elastase in the kidneys in patients with sepsis and acute kidney injury (AKI) by 11C-GW457427 measured with dynamic positron emission tomography (PET) sex: ALL minimumAge: 30 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06372431 id: D1843R00360 briefTitle: PRospectIve ObseRvatIonal mulTicenter Study of Patients With Arterial hYpertension and CKD in the Population of Russia acronym: PRIORITY-CKD overallStatus: NOT_YET_RECRUITING date: 2024-04-24 date: 2025-10-31 date: 2025-10-31 date: 2024-04-18 date: 2024-04-18 name: AstraZeneca class: INDUSTRY briefSummary: This study is a multi-centre, non-interventional, observational, prospective study with retrospective analysis. The main purpose of the study is to describe the rate of CKD diagnosis in patients with AH and CKD markers. This study will include 10 000 adult outpatients with arterial hypertension, who have one or more Chronic Kidney Disease laboratory markers (without recorded CKD diagnosis prior to enrolment) and have no diabetes mellitus or chronic heart failure, who are monitored and treated by cardiologists or internal medicine specialists in approximately 50 outpatient sites in about 20 regions in Russia. |
This observational study does not provide for any diagnostic and therapeutic procedures other than those used in routine practice. conditions: Arterial Hypertension, Chronic Kidney Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 10000 type: ESTIMATED measure: To describe the rate of CKD diagnosis in patients with AH and CKD markers. measure: To describe demographic and clinical characteristics of patients with AH and CKD markers measure: To describe clinical characteristics of patients with AH and diagnosed CKD during this study (on Visit 1 or Visit 2) and profile of routine therapy before and after CKD diagnosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06372418 id: KEMRI/SERU/CGMR-C/238/4326 briefTitle: Providing Breastfeeding Support After Discharge From Hospital to Improve Growth and Development of Malnourished Infants acronym: IBAMI-2 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-02 date: 2027-02 date: 2024-04-18 date: 2024-04-18 name: University of Oxford class: OTHER briefSummary: The current guidelines used to manage malnutrition among infants aged below 6 months (u6m) recommend that infants admitted to hospital with malnutrition be supported to reestablish exclusive breastfeeding before discharge. Studies have shown that reestablishing exclusive breastfeeding among infants being treated for acute malnutrition is possible. However, follow-up of the infants after discharge has revealed poor growth raising questions about what happens to infant feeding practices after discharge and whether providing breastfeeding support to mothers after discharge would help improve the recovery and growth of their infants. |
Providing a package of home-based care with breastfeeding support to mothers of infants u6m recovering from acute malnutrition has the potential to improve the retention of exclusive breastfeeding and lead to enhanced infant growth and survival. To date, no such post-discharge package of care is available in Kenya or other lower and meddle income countries (LMICs). The aim of this study is to apply participatory, qualitative and quantitative approaches to develop and evaluate the impact of a post-discharge package of care on the growth and development of acutely ill malnourished infants after discharge from hospital. conditions: Malnutrition, Infant conditions: Breastfeeding, Exclusive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Control Trial: |
Participants will be randomized to either receive Breastfeeding support intervention (BFSI) or standard of care. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Fieldworkers collecting endpoint data at 6 months of age will be blinded to group allocation to avoid any bias subject to knowledge of group allocation. whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: Breastfeeding peer support intervention name: Standard Care measure: Weight gain measure: Morbidity measure: Mortality sex: ALL minimumAge: 4 Weeks maximumAge: 12 Weeks stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06372405 id: PSP-501/D125/79/00000 briefTitle: Instructed Cognitive Reappraisal in Reducing Affective, Behavioral and Psychophysiological Symptoms of Misophonia overallStatus: RECRUITING date: 2024-03-18 date: 2024-12 date: 2025-09-30 date: 2024-04-18 date: 2024-04-18 name: University of Warsaw, Poland class: OTHER name: Duke University briefSummary: Misophonia is a disorder causing intense reactions to specific sounds, disrupting daily life. Current treatments lack evidence-based support. The goal of this study is to explore the effectiveness of cognitive reappraisal (CR) in reducing misophonic responses. The study involves 100 participants assigned to either a 4-week CR program or Autogenic Training. Emotional regulation, symptoms of anxiety and depression, quality of life, and more will be assessed using various questionnaire-based measures; perseverations with a task-based test (Wisconsin Card Sorting Test); the presence of psychiatric and personality disorders using face-to-face interviews (The Mini-International Neuropsychiatric Interview (M.I.N.I.) and "Structured Clinical Interview for DSM-5® Personality Disorders" (SCID-5-PD) conditions: Misophonia Treatment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 108 type: ESTIMATED name: Cognitive reappraisal name: Schultz Autogenic Training measure: Change in misophonia symptoms measured by S-Five - Externalizing subscale measure: Change in misophonia symptoms measured by S-Five - Internalizing subscale measure: Change in misophonia symptoms measured by S-Five - Threat subscale measure: Change in misophonia symptoms measured by S-Five - Impact subscale measure: CHange in misophonia symptoms measured by S-Five - Outburst subscale measure: Change of aversiveness rating (valence/pleasure) on the Manikin Scales. measure: Change of arousal rating on the Manikin Scales. measure: Change in Galvanic Skin Response measure: Change in average HR during the trigger presentation measure: Diagnosis of personality disorders as a predictor of worse treatment outcome. measure: Working Alliance Inventory will be related to better treatment outcomes. measure: Meeting criteria for psychiatric disorders - measure: Hearing test - standard and high frequency pure-tone audiometry sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Faculty of Psychology, University of Warsaw status: RECRUITING city: Warsaw state: Masovian Voivodeship zip: 00-183 country: Poland name: Marta Siepsiak, PhD role: CONTACT phone: 0048661152533 email: [email protected] name: Marta Siepsiak, PhD role: PRINCIPAL_INVESTIGATOR lat: 52.22977 lon: 21.01178 hasResults: False |
<|newrecord|> nctId: NCT06372392 id: 1.0 briefTitle: Universal Fixed Meal Boluses Usage in Patients With Medtronic Minimed 780G Pumps overallStatus: RECRUITING date: 2023-10-10 date: 2024-06-10 date: 2024-12-01 date: 2024-04-18 date: 2024-04-18 name: Tartu University Hospital class: OTHER name: Estonia Research Council briefSummary: Cross-over study of 20 pediatric patients (age 7-19) randomized to the group receiving universal fixed meal boluses coefficients (300/TDD for breakfast and 400/TDD other meal) or to the group with individualized coefficients for the period of 14 days with consecutive analysis of the results from Carelink Raport. conditions: Type1diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: Universal meal coefficient utilization measure: Time in range (TIR) measure: TBR measure: TAR measure: auto-corrections % measure: coefficient of variability sex: ALL minimumAge: 7 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: TartuUH status: RECRUITING city: Tartu state: Tartumaa zip: 50406 country: Estonia name: Aleksandr Peet role: CONTACT phone: 5532256 email: [email protected] lat: 58.38062 lon: 26.72509 hasResults: False |
<|newrecord|> nctId: NCT06372379 id: 8780_UC2 briefTitle: Development of a Multipurpose Dashboard to Monitor the Situation of Emergency Departments acronym: eCREAM-UC2 overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-01 date: 2027-09 date: 2024-04-18 date: 2024-04-18 name: Mario Negri Institute for Pharmacological Research class: OTHER name: Astir S.r.l. name: Orobix Life S.r.l. name: Fondazione Bruno Kessler briefSummary: An emergency department (ED) is a healthcare service that provides the first clinical assessment and treatment to patients with various acute conditions. These departments, however, are often overwhelmed by the large volume of patients. As a consequence, ED crowding has become a global concern and has been correlated to reduced timeliness and effectiveness of care and increased patient mortality. Concerning input, 20% to 30% of patients are brought to the ED by ambulance; the remaining are self-presenting for the vast majority. Notably, non-urgent conditions characterize a high proportion of all ED visits worldwide, and almost all of these visits involve self-presenting patients. Increasing the awareness of these patients about the mandate of EDs and the real-time situation of the neighboring emergency departments has the potential to reduce the self-presentation of patients with minor, non-urgent conditions. Such patient empowerment can be achieved through a dashboard. Concerning throughput, working in the ED requires emergency physicians and nurses to treat many patients at once while maintaining situational awareness of the surroundings. This is especially true for the head of the department, but it also holds for all physicians. It can be crucial, for example, for physicians to know if there is a bottleneck in the flow of the entire patient care process, such as a particularly high average waiting time for radiology reporting or cardiologic consultation. The availability of this information allows countermeasures to be put in place to regain efficiency. All this can be achieved through dedicated dashboards automatically fed from various information system. In addition, appropriate dashboards also enable health policymakers to monitor specific epidemiological phenomena, such as the emergence of certain infectious diseases, in a timely manner. conditions: Emergency Medicine studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 162000 type: ESTIMATED name: no intervention measure: Daschboards sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06372366 id: Dental caries and vit.difiency briefTitle: Relationship Between Vitamins Deficiency and Caries Experience Among a Group of Egyptian Children overallStatus: NOT_YET_RECRUITING date: 2024-07-15 date: 2024-10-15 date: 2025-12-15 date: 2024-04-18 date: 2024-04-19 name: Cairo University class: OTHER briefSummary: Dental caries is a worldwide condition characterized by localized destruction of dental hard tissue by acidic by-products from bacterial fermentation of dietary carbohydrates . Dental caries is considered to be the single most common chronic childhood disease, and its prevalence is thought to have increased recently. conditions: Dental Caries conditions: Vitamin Deficiency studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 2 type: ESTIMATED measure: Caries prevalence sex: ALL minimumAge: 3 Years maximumAge: 5 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06372353 id: 777 briefTitle: The Effect Of Baduanjin Exercises In Patients With Idiopathic Pulmonary Fibrosis overallStatus: COMPLETED date: 2022-06-01 date: 2023-05-24 date: 2023-06-06 date: 2024-04-18 date: 2024-04-18 name: Marmara University class: OTHER briefSummary: Introduction and Objectives:IPF, characterized by shortness of breath and progressive deterioration in lung function.Baduanjin (BJ) is a mindbody health exercise that combines physical exercise with psychological properties to maximize both physical and mental health.The aim of the study is to investigate the effectiveness of these exercises in patients with IPF and to present an alternative in terms of the applicability of BJ exercises as a new treatment method |
Methods: 28 volunteers were invited to the study.These patients were randomly divided into 2 groups.The subjects in the exercise group were given 24 sessions of supervised online BJ exercise training, 3 days a week, for 8 weeks. The patients included in the control group did not receive any training during the 8 week period conditions: Pulmonary Fibrosis, Idiopathic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 28 type: ACTUAL name: Baduanjin Exercise measure: Functional capacity measure: Pulmonary Function Tests measure: Pulmonary Function Tests measure: Pulmonary Function Tests measure: Pulmonary Function Tests measure: Respiratory muscle strength measure: Respiratory muscle strength measure: St. George's Respiratory Questionnaire sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: İstanbul University - Cerrahpaşa city: Istanbul state: Fatih country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06372340 id: 2023BJYYEC-217-01 briefTitle: Intelligent Diagnosis and Treatment System for Pelvic Floor Dysfunction in Elderly Women overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-08-31 date: 2025-12-31 date: 2024-04-18 date: 2024-04-18 name: Beijing Hospital class: OTHER_GOV briefSummary: The aim of this study is to propose an intelligent diagnosis and treatment system for for pelvic floor dysfunction in elderly women. The main question it aims to answer: 1) How can the investigators find out early if older women have different pelvic floor muscle functions? 2）How can the investigators give personalized treatment plans based on differences in pelvic floor function? Participants will be assigned different training programs by the system. The investigators will compare the treatment effects and costs of older women with pelvic floor dysfunction using and not using the system. All the participants will be offered examinations for pelvic floor function and different treatments. All examinations and treatments are non-invasive. conditions: Pelvic Organ Prolapse conditions: Urinary Incontinence conditions: Diagnosis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The participants will be allocated to experimental group(EG) or the control group(CG). Subjects in the experimental group (EG) will receive personalized pelvic floor muscle training guidance provided by the system, whereas subjects in the control group(CG) will exercise according to the handbook or oral guidance. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Assessments regarding pelvic floor muscle strength will be conducted by an assessor blind to treatment allocation. The assessor will go through a profound assessment training program. Due to the nature of the intervention neither participants nor care providers can be blinded to allocation, but are strongly inculcated not to disclose the allocation status of the participant at the follow up assessments. An employee outside the research team will feed data into the computer in separate datasets so that the researchers can analyse data without having access to information about the allocation. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Personalized pelvic floor rehabilitation program generated by the intelligent diagnosis and treatment system. name: Standard pelvic floor muscle training(PFMT) program measure: Modified Oxford Scale (MOS) measure: Surface Electromyography Data measure: The score of Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) measure: The score of the Pelvic Floor Distress Inventory (PFDI-20) measure: Subjective staging used Pelvic Organ Prolapse Quantification (POP-Q) System sex: FEMALE minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06372327 id: 73468 briefTitle: Move Often eVery Day 2.0 acronym: MOVD overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-07 date: 2024-04-18 date: 2024-04-19 name: Stanford University class: OTHER briefSummary: The purpose of this study is to assess a novel, widely-accessible intervention to both promote active breaks from work and improve cognitive and psychological performances at work in motivationally-accessible bouts. This will be done by interrupting prolonged sitting with 1-4 short (1-4 minutes), moderate-to-vigorous physical activity (MVPA) bouts with no equipment, and simple video-based instructions. The short bouts will be referred to as "exercise snacks." In this proposed exercise snacks intervention, investigators explicitly target a population with sedentary jobs due to the generalizability. conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: This will be a 2 (Exercise snack number) x 2 (Exercise snack length) factorial design. primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: Daily Exercise Snacks measure: Number of self-reported exercise snack breaks at work at week 7 measure: Number of self-reported exercise snack breaks at work at week 18 measure: Number of self-reported exercise snack breaks at work at week 30 during follow-up measure: Liking of exercise snacks sex: FEMALE minimumAge: 30 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University School of Medicine city: Stanford state: California zip: 94305-7240 country: United States lat: 37.42411 lon: -122.16608 hasResults: False |
<|newrecord|> nctId: NCT06372314 id: 1000081221 briefTitle: Isoleucine, Leucine, Valine and Tryptophan Requirements in TPN Fed Neonates overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2027-12 date: 2027-12 date: 2024-04-18 date: 2024-04-18 name: The Hospital for Sick Children class: OTHER briefSummary: This project will be conducted in 2 hospitals in Brazil to assess the requirements for four essential amino acids in TPN fed neonates. Using the Carbon Oxidation method (indicator amino oxidation and direct amino acid oxidation method), the investigators will determine the requirement of each of the 4 amino acids. |
The investigators will determine the requirement for Isoleucine, Leucine, Valine and Tryptophan. The investigators will recruit 18- 20 babies per amino acid study. Breath and urine samples will be collected to determine the oxidation of the indicator amino acid. The response of the indicator amino acid to changes in intake of the test amino acid (isoleucine, leucine, valine and tryptophan) will be analyzed by bi-phase linear mixed effect model to determine the breakpoint or mean requirement for each amino acid. It is hypothesized that the requirement for isoleucine, leucine, valine and tryptophan will be at least 50% lower than what is currently available in commercial solutions used for TPN feeding of neonates. conditions: Stable Neonates Receiving Total Parenteral Nutrition (TPN) studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 80 type: ESTIMATED name: Total parenteral nutrition (TPN): this is total nutrition provided by central vein. measure: Amino acid oxidation using a labelled amino acid. sex: ALL minimumAge: 1 Day maximumAge: 28 Days stdAges: CHILD facility: Hospital de Caridade Dr. Astrogildo de Azevedo, and University Hospital of Santa Maria, Santa Maria, Brazil city: Santa Maria country: Brazil name: Ivo Dr Prola, MD, PhD role: CONTACT phone: 6477815786 email: [email protected] name: Beatriz Dr Porto, MD role: CONTACT phone: 6475002171 email: [email protected] lat: -29.68417 lon: -53.80694 hasResults: False |
<|newrecord|> nctId: NCT06372301 id: 1-10-72-179-23 briefTitle: Dobutamine Stress Echocardiography in LF/LG Aortic Stenosis and Wild-type Transthyretin Amyloid Cardiomyopathy acronym: DobAttrAS overallStatus: RECRUITING date: 2024-04-02 date: 2025-11-01 date: 2026-04-01 date: 2024-04-18 date: 2024-04-18 name: Steen Hvitfeldt Poulsen class: OTHER briefSummary: The goal of this prospective clinical study is improve the diagnosis of Low-flow low-gradient aortic stenosis (LF/LG AS), in patients with co-existing wild-type transthyretin cardiac amyloidosis (ATTRwt). The main question it aims to answer is whether the classic dobutamine-stress echocardiography can be used to determine AS severity in patients with ATTRwt and LF/LG AS This question will be tried to answer by comparing dobutamine stress echocardiography, with the invasively measured aortic valve area (which is considered as the gold standard). |
In addition we aim to assess the degree of myocardial fibrosis and amyloid infiltration, assessed by light microscopy and cardiac magnetic resonance (CMRI) and evaluation of myocyte mitochondrial function by high resolution respirometry and their relation to AS severity and hemodynamic response to dobutamine. conditions: Transthyretin Amyloid Cardiomyopathy conditions: Aortic Stenosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 24 type: ESTIMATED name: Dobutamine stress echocardiography measure: The correlation between echocardiography derived projected aortic valve area (AVAproj) and invasively assessed AVAproj under dobutamine infusion. measure: Correlation between echocardiography derived AVA and invasively assessed AVA at rest and at different dobutamine infusion levels. measure: Increase of SVI, LV ejection fraction and LV-global longitudinal strain of 10 % during maximal dobutamine stimulation. measure: Correlation between echo- and invasive measured SVI. measure: Degree of myocardial fibrosis, amyloid infiltration and mitochondrial dysfunction and its relation to AS severity and hemodynamic response to dobutamine measure: Reduction of mean pulmonary artery wedge pressure and/or mean pulmonary artery pressure by 10 %. measure: Complication rate and symptomatic side effects during dobutamine challenge 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: [email protected] lat: 56.15674 lon: 10.21076 hasResults: False |
<|newrecord|> nctId: NCT06372288 id: 22-1754 briefTitle: Theta Burst TMS for Treatment of Methamphetamine Use Disorder overallStatus: RECRUITING date: 2023-12-20 date: 2024-12 date: 2025-12 date: 2024-04-18 date: 2024-04-26 name: Carilion Clinic class: OTHER name: Virginia Polytechnic Institute and State University briefSummary: This study is using Transcranial Magnetic Stimulation (TMS) to determine if interventional psychiatry treatment can help with the treatment of Methamphetamine Use Disorder. Individuals with Methamphetamine Use Disorder will receive 5 consecutive TMS treatment sessions based off of randomization. Participants will be randomized to one of two groups. TMS treatment arm or sham-TMS arm. conditions: Methamphetamine Abuse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to either receive 5 transcranial magnetic stimulations or 5 sham transcranial magnetic stimulation (no therapeutic levels of stimulation) sessions. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: One study personnel not involved in participant interventions will be unblinded and will randomize participants and confirm the set up of the device for the session prior to the blinded study personnel interacting with the participant. Both the participant and the blinded study personnel will not know which group the participant will be part of throughout the study sessions. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Transcranial Magnetic Stimulation name: Sham Transcranial Magnetic Stimulation measure: Stimulant Craving Questionnaire (STCQ) measure: Urine Drug Screen (UDS) measure: Generalized Anxiety Disorder-7 (GAD-7) measure: Patient Health Questionnaire-9 (PHQ-9) measure: Quality - Life Enjoyment Scale - Questionnaire (Q-LES-Q) measure: Hamilton Anxiety Scale (HAM-A) measure: Montgomery Asberg Depression Rating Scale (MADRS) measure: Clinical Global Impression - Severity (CGI-S) measure: Clinical Global Impression - Improvement (CGI-I) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Carilion Clinic status: RECRUITING city: Roanoke state: Virginia zip: 24014 country: United States name: Sooraj John, M.D. role: CONTACT name: Maryann Hollen, B.S. role: CONTACT phone: 540-566-8081 lat: 37.27097 lon: -79.94143 hasResults: False |
<|newrecord|> nctId: NCT06372275 id: 0000 briefTitle: Investigating Two Prototype Mobile App Interventions to Increase Physical Activity overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-08-31 date: 2024-08-31 date: 2024-04-17 date: 2024-04-17 name: Mississippi State University class: OTHER name: Association for contextual behavioral science briefSummary: This randomized control trial aims to investigate whether writing about personal values helps enhance motivation to engage in physical activity, relative to general self-reflective writing. This study will help to (1) assess whether values clarification leads to increased motivation to engage in physical activity, greater stability in motivation, and improvements in engagement in physical activity and valued action, relative to engaging in self-reflection, (2) determine if the impact of values clarification on these outcomes vary depending on context (e.g., positive/negative affect, psychological inflexibility, stressful events), (3) explore whether values clarification procedures that employ distinct relational frames (hierarchical, conditional, distinction, and deictic) differentially impact motivation to engage in physical activity, and daily engagement in physical activity, and (4) explore whether the impact of values clarification vary depending on baseline self-compassion and/or intrinsic/extrinsic motivation. conditions: Health-Related Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Values Clarification Mobile Application name: Self-Reflection Mobile Application measure: International Physical Activity Questionnaire (IPAQ) - Total physical activity measure: Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) - Total score measure: Amotivation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) measure: External Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) measure: Introjected Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) measure: Identified Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) measure: Integrated Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) measure: Intrinsic Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Questionnaire v1.2 measure: Global Mental Health - Subscale of the PROMIS Global Health Questionnaire v1.2 (Patient-Reported Outcomes Measurement Information System) measure: Global Physical Health - Subscale of the PROMIS Global Health Questionnaire v1.2 (Patient-Reported Outcomes Measurement Information System) measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Satisfaction with Social Roles and Activities 8a measure: Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24) measure: Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24) measure: Lack of Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24) measure: Values Clarity Questionnaire (VCQ) measure: Self-Compassion Scale Short Form (SCS-SF) measure: Random responding question measure: Credibility & Expectancy Questionnaire (CEQ) measure: System Usability Scale (SUS) measure: Treatment Evaluation Inventory-Short Form (TEI-SF) measure: Exercise ecological momentary assessment (EMA) questions measure: Multidimensional Psychological Flexibility Inventory - Short Form 24-item version adapted for ecological momentary assessment (MPFI-24 validated for EMA) measure: Momentary Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version adapted for ecological momentary assessment (MPFI-24 validated for EMA) measure: Momentary Lack of Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version adapted for ecological momentary assessment (MPFI-24 validated for EMA) measure: Emotion ratings measure: Current Motivation to Exercise measure: Previous Day Stress Level sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mindfulness and Acceptance Processes Lab city: Starkville state: Mississippi zip: 39759 country: United States lat: 33.45049 lon: -88.81961 hasResults: False |
<|newrecord|> nctId: NCT06372262 id: Rowers2022 briefTitle: Effect of 2000-meter Rowing Test on Parameters of Intestinal Integrity in Elite Rowers During Competitive Phase acronym: Rowers overallStatus: COMPLETED date: 2022-06-01 date: 2022-06-30 date: 2022-06-30 date: 2024-04-17 date: 2024-04-17 name: Poznan University of Physical Education class: OTHER briefSummary: The study aimed to check the 2000m ergometer test on markers of gut permeability in the competitive phase of rowers. 18 members of the Polish rowing team took part in the study. conditions: Endothelial Dysfunction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 18 type: ACTUAL name: ergometer test measure: I-FABP (intestinal fatty acid binding protein)to measure epithelial wall injury measure: zonulin to measure tight junction leakage measure: LBP (lipopolysaccharide binding protein) to measure endotoxin measure: LPS (lipopolysaccharide) to measure endotoxin measure: Lactic acid to measure fatigue after the race measure: energy measure: fiber intake measure: protein measure: carbohydrate measure: body mass measure: Body composition - water measure: Body composition - fat measure: Lean body mass sex: MALE minimumAge: 18 Years maximumAge: 23 Years stdAges: ADULT facility: Poznan University of Physical Education city: Poznań country: Poland lat: 52.40692 lon: 16.92993 hasResults: False |
<|newrecord|> nctId: NCT06372249 id: 22-249 id: 2U54MD012388-06 type: NIH link: https://reporter.nih.gov/quickSearch/2U54MD012388-06 briefTitle: A Clinical Trial of Soluble Fiber for Asthma overallStatus: RECRUITING date: 2024-04-02 date: 2027-04 date: 2027-04 date: 2024-04-17 date: 2024-04-17 name: Phoenix Children's Hospital class: OTHER name: Northern Arizona University name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: Randomized controlled trial of soluble fiber (NOVELOSETM 3490). Participants will complete an ASA 24 dietary recall questionnaire to access their fiber intake. If eligible for the study, participants will be supplemented to their target fiber dosage with either soluble fiber (NOVELOSETM 3490) or placebo. Collection of blood serum, fecal samples, and nasal wash will aid in analyzing the microbes present in one's gut and how fiber and diet may impact it. Thus, allowing researchers to better understand the pathways that may connect diet and asthma and if it is possible to improve asthma by altering one's diet. conditions: Asthma in Children studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 105 type: ESTIMATED name: NOVELOSETM 3490 measure: Alpha diversity. measure: Asthma control. measure: Gut microbiome composition. measure: Nasal inflammatory response. measure: Quantification of circulating short chain fatty acids. sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: Phoenix Children's status: RECRUITING city: Phoenix state: Arizona zip: 85016 country: United States name: Destiny Ogbeama role: CONTACT lat: 33.44838 lon: -112.07404 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-17 uploadDate: 2024-04-02T16:19 filename: Prot_SAP_000.pdf size: 285020 hasResults: False |
<|newrecord|> nctId: NCT06372236 id: PG-001-025 briefTitle: UTAA06 Injection for Treatment of Advanced Malignant Solid Tumors overallStatus: RECRUITING date: 2023-12-01 date: 2024-12-01 date: 2026-12-01 date: 2024-04-17 date: 2024-04-17 name: Peking University class: OTHER briefSummary: This is a single-arm, open, early-stage clinical study. The main purpose of this study is to explore the maximum tolerated dose (MTD), the optimal phase II recommended dose, safety, initial anti-tumor activity, cytopharmacokinetics, immunogenicity, biomarkers and other characteristics of drug therapy in patients with advanced malignant solid tumors. Eligible subjects were transfused with UTAA06 injection after pretreatment, and their blood was collected before and after infusion for evaluation of cytopharmacokinetics, safety, immunogenicity and biomarkers. In this study, tumor evaluation was mainly performed using RECISTv1.1. In addition to the baseline period, the therapeutic efficacy was evaluated at the frequency of Q3m during 4w, 2m, 3m, and 6-24m after cell infusion. Tumor evaluation was performed until disease progression (PD), new anti-tumor therapy, death, intolerable toxicity, investigator's decision, or patient's voluntary withdrawal. Whichever comes first. conditions: Conditions or Focus of Study: B7-H3 Positive Relapsed/Advanced Malignant Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: UTAA06 injection primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: UTAA06 injection for treatment of advanced malignant solid tumors measure: MTD measure: To evaluate the preliminary antitumor activity of UTAA06 injection in patients with advanced malignant solid tumors measure: To evaluate the number of participants with treatment-related adverse events of UTAA06 injection in patients with advanced malignant solidtumors. measure: To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors. measure: To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors. measure: To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors. measure: To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors. measure: To evaluate the pharmacokinetic (PK) characteristics of UTAA06 injection in patients with advanced malignant solid tumors. measure: To evaluate the pharmacokinetic (PK) characteristics of UTAA06 injection in patients with advanced malignant solid tumors. measure: To evaluate the immunogenicity of UTAA06 injection in patients with advanced malignant solid tumors. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PersonGen Anke Cellular Therapeutice Co.,Ltd status: RECRUITING city: Hefei state: Anhui zip: 230088 country: China name: Huimin Meng, Doctor role: CONTACT phone: +86-18015580390 email: [email protected] lat: 31.86389 lon: 117.28083 hasResults: False |
<|newrecord|> nctId: NCT06372223 id: SPH5030-102 briefTitle: A Food Effect Study of SPH5030 Tablets. overallStatus: COMPLETED date: 2024-03-04 date: 2024-03-25 date: 2024-03-25 date: 2024-04-17 date: 2024-04-17 name: Shanghai Pharmaceuticals Holding Co., Ltd class: INDUSTRY briefSummary: The purpose of this study is to evaluate the food effect of SPH5030 tablets in healthy Chinese adult subjects. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 16 type: ACTUAL name: SPH5030 name: SPH5030 measure: Peak Plasma Concentration (Cmax) measure: Peak time（Tmax） measure: Area under the plasma concentration versus time curve (AUC) measure: Incidence of Treatment-Emergent Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: West China Second Hospital ,Sichuan University city: Chengdu country: China lat: 30.66667 lon: 104.06667 hasResults: False |
<|newrecord|> nctId: NCT06372210 id: 031-201-00521 briefTitle: A Trial to Assess a Wearable Patch's Functioning to Detect Medication Ingestion overallStatus: COMPLETED date: 2023-06-26 date: 2023-07-19 date: 2023-07-19 date: 2024-04-17 date: 2024-04-17 name: Otsuka Pharmaceutical Development & Commercialization, Inc. class: INDUSTRY briefSummary: The primary purpose of the study is to evaluate the positive detection accuracy (PDA) and detection latency measures of the D-Tect patch. conditions: Mental Disorder conditions: Schizophrenia conditions: Major Depressive Disorder conditions: Bipolar I Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 54 type: ACTUAL name: Placebo IEM tablet name: Abilify MyCite® name: D-Tect Patch measure: Cohort 1: Positive Detection Accuracy (PDA) of D-Tect Patch measure: Cohort 1 and 2: Patch Detection Latency Period measure: Cohort 1 and 2: Ingestion Data Transfer Latency Period measure: Cohort 1 and 2: Total Detection Latency Period measure: Number of Participants With Adverse Events (AEs) Graded By Severity, Device-related AEs, Serious AEs (SAEs), AEs Leading to Trial Discontinuation, and Unanticipated Adverse device Effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research site city: Garden Grove state: California zip: 92845 country: United States lat: 33.77391 lon: -117.94145 hasResults: False |
<|newrecord|> nctId: NCT06372197 id: LIGPATD briefTitle: Low-Income Group Psilocybin Assisted Therapy for Depression acronym: LIGPATD overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2024-08 date: 2024-10 date: 2024-04-17 date: 2024-04-17 name: Matthew Hicks class: OTHER briefSummary: Due to psilocybin-assisted therapy's success in previous research, growing cultural awareness and use of psilocybin and other psychedelics, the Oregon Psilocybin Services Act passed by ballot measure in 2020 and began offering services in 2023. While the program has had many successes, a significant problem it faces is affordability and no research to date has investigated the therapy in a low-income population. |
Psychedelic research in recent decades has used the model of two therapists to one client to demonstrate an abundance of caution and safety to regulators, but no evidence has demonstrated this model to be safer or more effective than one with less practitioner oversight. This feasibility study would be the first investigation of Oregon Psilocybin Services as a model of care and among the first few to use a group therapy model. This study aims to test the feasibility of the model by assessing recruitment, retention, acceptability and safety of the treatment. In addition to an appropriate medical screening and intake the following questionnaire data will be collected: the Adverse Childhood Events (ACE) questionnaire, Credibility/Expectancy Questionnaire (CEQ), PROMIS-29, Altered States of Consciousness (11-ASC) rating scale, and a survey and structured interview. |
Participants will consist of adults in Oregon with an income at or below 200% of the federal poverty level. Inclusion criteria will include DSM-5 diagnosis of major depression. Participants will be individually screened by a study investigator and placed into groups of five to six participants. Treatment will consist of two group preparation sessions, two psilocybin sessions, and two group integration sessions. An additional follow-up visit to collect further data will take place three months after conclusion of the treatment. |
The proposed study will provide valuable information for designing future clinical trials investigating the efficacy, mechanisms, and cost-effectiveness of psilocybin-assisted group therapy for depression in low-income populations. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Psilocybin measure: Recruitment Feasibility measure: Retention Feasibility measure: Acceptability measure: Preliminary Safety and Tolerability: incidence and severity of adverse events measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29) measure: Altered State of Consciousness rating scale (11-ASC) sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06372184 id: WMT-AR-RCT briefTitle: Washed Microbiota Transplantation for Allergic Rhinitis overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2029-06-01 date: 2029-10-01 date: 2024-04-17 date: 2024-04-17 name: The Second Hospital of Nanjing Medical University class: OTHER briefSummary: Allergic rhinitis (AR) is characterized by sneezing, nasal congestion, nasal itching and nasal leakage and is caused by immunoglobulin E (IgE)-mediated reactions to inhaled allergens. Increasing evidence showed that gut microbiota could influence the development of AR, and we found that washed microbiota transplantation (WMT) could improve nasal symptoms in clinical practice. This clinical trial aims to evaluate the efficacy and safety of WMT for AR. conditions: Rhinitis, Allergic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 32 type: ESTIMATED name: Washed Microbiota Transplantation name: Placebo measure: Changes in the reflective total nasal symptom score (rTNSS) measure: Changes in the combined symptoms and medication score (CSMS) measure: Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score measure: Changes in the single reflective nasal symptoms score measure: Specific IgE measure: Inflammatory factors measure: Flow cytometric analysis of lymphocyte clusters measure: The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 measure: Changes in the Modified Lund-Kennedy endoscopic score measure: The changes in composition and metabolites of gut microbiota and nasal microbiota sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210011 country: China name: Faming Zhang, MD,PhD role: CONTACT phone: 086-25-58509883 email: [email protected] lat: 32.06167 lon: 118.77778 hasResults: False |
<|newrecord|> nctId: NCT06372171 id: NYCU112182AEF briefTitle: Effects of Liposomal Encapsulation on Vitamin C Absorption and Metabolism overallStatus: RECRUITING date: 2024-04 date: 2024-09 date: 2024-12 date: 2024-04-17 date: 2024-04-17 name: National Yang Ming University class: OTHER briefSummary: Vitamin C is an important antioxidant in the human body and plays many important roles. It is currently known that vitamin C has the functions of treating scurvy, assisting in collagen synthesis, whitening, and increasing immunity. Smokers, patients with cardiovascular disease, and patients with diabetes may have higher requirements for vitamins due to higher oxidative stress in the body. Liposome coating is a technology commonly used in food processing and medicine to protect active substances, increase absorption or slow release. Currently, vitamin C is commonly available on the market as an additive nutritional supplement in the form of powder packets, tablets, etc. The disadvantages are that vitamin C is relatively unstable, easily destroyed by gastric acid, and maintains blood concentration for a short time. Taking liposome microbial C has been Found to have the potential to increase bioavailability in the human body, it is expected that vitamin C coated with lecithin is relatively stable and can be stabilized in the small intestine without being damaged by gastric acid, while reducing the risk of gastrointestinal discomfort caused by the acidity of vitamin C. According to the revised seventh edition of the Reference Intake of Dietary Nutrients for Chinese People, the upper daily intake of vitamin C (tolerable upper intake levels, UL) for people aged 19 to 70 is 2,000 mg. According to literature, the absorption rate of vitamin C when consuming 30-180 mg per day is about 70-90%; when the daily intake exceeds 1000 mg, the absorption rate will drop to less than 50%. The dose of vitamin C used in this study is more than 1500 mg. The purpose is to explore whether the sustained-release characteristics of liposome coating technology can improve the absorption rate and achieve better bioavailability when consuming high-dose vitamin C powder. It is expected that through the egg The liposome vitamin C powder made of phospholipids increases its maintenance time in the blood, thereby increasing the supplementary effect of vitamin C powder and serving as another supplement option for vitamin C. conditions: Nutrition, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: Satge 1 name: Stage 2 measure: General examination 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: [email protected] lat: 25.04776 lon: 121.53185 hasResults: False |
<|newrecord|> nctId: NCT06372158 id: NYCU112181AE briefTitle: Effects of Liposomal Encapsulation on Calcium Powder Absorption and Metabolism overallStatus: RECRUITING date: 2024-04-08 date: 2024-12 date: 2024-12 date: 2024-04-17 date: 2024-04-17 name: National Yang Ming University class: OTHER briefSummary: Compared with traditional calcium supplements, liposome calcium can increase the bioavailability of calcium and reduce the waste caused by gastric acid destruction of calcium. This allows calcium to be released slowly in the intestines, reducing the risk of indigestion or other side effects caused by excessive intake at one time. Liposomal calcium can be taken orally directly. It does not need to be dissolved in water before taking like other calcium supplements, making it more convenient to use. Based on the above advantages, liposomal calcium is a relatively safe and easy-to-absorb calcium supplement, suitable for long-term use, and can meet the body's demand for calcium. According to the recommendations of the World Health Organization, the daily calcium intake for adults should be 1000-1300 mg. In Taiwan, the seventh edition of the revised reference intake of dietary nutrients for Chinese people recommends that the daily intake for adults should be 1,000 mg. The calcium dose used in this study was 500 mg. The purpose was to explore whether the sustained-release characteristics of liposome coating technology can improve the absorption rate after consuming calcium powder and achieve better bioavailability. It is expected that microlipids made by lecithin can Lipid calcium powder increases its maintenance time in the blood, thereby increasing the supplementary effect of calcium, and is an alternative to calcium supplements. conditions: Osteoporosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: Stage 1 name: Stage 2 measure: General examination 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: [email protected] lat: 25.04776 lon: 121.53185 facility: National Yang Ming Chiao Tung University status: RECRUITING city: Taipei zip: 112 country: Taiwan name: ChienYu Huang, Bachelor role: CONTACT phone: +886-955-879163 email: [email protected] lat: 25.04776 lon: 121.53185 hasResults: False |
<|newrecord|> nctId: NCT06372145 id: LTS17043 id: 2023-503631-18 type: REGISTRY domain: CTIS id: U1111-1287-6797 type: REGISTRY domain: ICTRP briefTitle: A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis. overallStatus: RECRUITING date: 2024-04-25 date: 2029-04-30 date: 2029-04-30 date: 2024-04-17 date: 2024-04-17 name: Sanofi class: INDUSTRY briefSummary: This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 \[EFC16033\], GEMINI 2 \[EFC16034\], HERCULES \[EFC16645\], or PERSEUS \[EFC16035\]). |
SUBSTUDY: ToleDYNAMIC substudy conditions: Relapsing Multiple Sclerosis conditions: Secondary Progressive Multiple Sclerosis conditions: Progressive Relapsing Multiple Sclerosis studyType: INTERVENTIONAL phases: PHASE3 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 2500 type: ESTIMATED name: Tolebrutinib name: Placebo name: Teriflunomide measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs leading to permanent study intervention discontinuation measure: Number of Participants with Potentially clinically significant abnormalities (PCSAs) measure: Time to onset of 6-month confirmed disability worsening (CDW for RMS) or confirmed disability progression (CDP for PPMS and NRSPMS) for participants from pivotal studies measure: Annualized Relapse Rate (ARR) for RMS only measure: Number of new and/or enlarging T2-hyperintense lesions per year measure: Change from baseline in total volume of T2-hyperintense lesions measure: ToleDYNAMIC substudy Change from baseline in biomarkers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Investigational Site Number : 0560005 status: RECRUITING city: Brugge zip: 8000 country: Belgium lat: 51.20892 lon: 3.22424 hasResults: False |
<|newrecord|> nctId: NCT06372132 id: NL85305.068.23 briefTitle: G-POEM vs PEG-J in Gastroparesis Patients overallStatus: RECRUITING date: 2024-03-14 date: 2027-01 date: 2028-01-01 date: 2024-04-17 date: 2024-04-17 name: Maastricht University Medical Center class: OTHER briefSummary: Study design: A randomized non-blinded controlled clinical trial with two study arms (G-POEM and PEG-J). Treatment success is measured using the GCSI at baseline before intervention and six months after intervention with a possible cross-over after six months of follow-up. |
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