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<\|newrecord\|> nctId: NCT06356051 id: Gbuyukyilmaz briefTitle: Cardiovascular Disease Risk in Children With Type 1 Diabetes Mellitus overallStatus: COMPLETED date: 2023-01-01 date: 2023-06-01 date: 2023-09-01 date: 2024-04-10 date: 2024-04-10 name: Ankara City Hospital Bilkent class: OTHER briefSummary: Epicardial fat thickness, carotid intima-media thickness, and augmentation index from arterial stiffness indicators are increased in children with T1DM compared to the healthy control group. These results support the idea that children with T1DM present significant changes in important subclinical indicators for the development of cardiovascular disease. conditions: Type 1 Diabetes studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 202 type: ACTUAL name: Echocardiography measure: Epicardial fat thickness measure: carotid intima-media thickness measure: arterial stiffness parameters such as pulse wave velocity, augmentation index sex: ALL minimumAge: 8 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Ankara Bilkent City Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-01-04 uploadDate: 2024-03-30T05:04 filename: Prot_SAP_000.pdf size: 347934 hasResults: False
<\|newrecord\|> nctId: NCT06356038 id: Prot. n. 76 SA/2022 briefTitle: Phrenic Nerve Infiltration: Pulmonary Expansion and Pain Control overallStatus: ACTIVE_NOT_RECRUITING date: 2022-03-09 date: 2025-01-02 date: 2025-01-02 date: 2024-04-10 date: 2024-04-10 name: Azienda Ospedaliera "Sant'Andrea" class: OTHER briefSummary: Between January 2021-2023, 65 consecutive patients at risk for PAL (defined in accordance to "2019 Society of Thoracic Surgery score-criteria of PAL") underwent lung resection (lobectomy or sublobar resection) for malignancy. 5 patients were lost. The remaining have been assigned with a 1:2 randomization into: group A (22 patients), received intra-operative phrenic nerve infiltration with Ropivacaine 10 mg/ml in the peri-neurotic fat on the pericardium and group B (38 patients), did not receive infiltration. Data on hemidiaphragm elevation, air leaks, pain at 24 and 72 hours post-surgery, shoulder pain, length of hospital stay, length of chest tube permanence, were retrospectively collected and compared.The aim of the study is to investigate the effect of intra-operative phrenic nerve infiltration with long acting anesthetic in patients at high risk for PAL, improving pulmonary expansion after surgery, and reducing air leaks, while controlling post-operative pain. conditions: Prolonged Air Leak conditions: Post-operative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 66 type: ACTUAL name: intra-operative phrenic nerve infiltration measure: rate of pulmonary expansion due by phrenic nerve intra-operative local anaesthetic infiltration measure: rate of post-operative pain control after intra-operative phrenic nerve infiltration with local anaesthetic sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliera "Sant'Andrea" city: Roma country: Italy lat: 41.89193 lon: 12.51133 hasResults: False
<\|newrecord\|> nctId: NCT06356025 id: 52082 id: 2024-512546-42 type: EUDRACT_NUMBER briefTitle: Botulinum Toxin Injection in the UES for R-CPD acronym: BOTUS R-CPD overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-07 date: 2027-07 date: 2024-04-10 date: 2024-04-10 name: AZ Delta class: OTHER name: KU Leuven briefSummary: The aim of this study is to assess the effect of botulinum toxin injection into the upper esophageal sphincter in a double blind, placebo controlled study. Investigators want to assess the effect on symptoms short term (1-20 weeks after BT injection), and long term (48 weeks after BT injection).
This is a prospective double-blind randomized placebo-controlled study. Questionnaires assessing symptoms will be filled out on several occasions. At 20 weeks, a reassessment of symptoms will be done, without unblinding patients or investigator. Failures (to BT or placebo, defined as no clinical improvement or improvement less than 50%) will get the chance to receive a second procedure with active treatment (BT) in open label. conditions: Retrograde Cricopharyngeus Dysfunction studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: botulinum toxin type A name: Sodium Chloride 0.9% Inj measure: Change of at least 50% of 'inability to belch' using the symptom questionnaire at week 12. measure: Change in associated gastrointestinal symptoms: abdominal bloating/discomfort measure: Change in associated gastrointestinal symptoms: abdominal/chest pain measure: Change in associated gastrointestinal symptoms: flatulence measure: Change in associated gastrointestinal symptoms: gurgling noises from the chest/lower neck measure: Change of at least 50% of 'inability to belch' during long term follow-up at week 20, and at 48 weeks. measure: Overall treatment effect (OTE) measure: Overall symptom severity (OSS) measure: EuroQol-5D (EQ-5D) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06356012 id: 71163523.1.0000.5437 briefTitle: Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated With Imiquimod overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2026-12-31 date: 2028-12-31 date: 2024-04-10 date: 2024-04-10 name: Barretos Cancer Hospital class: OTHER name: Fundação de Amparo à Pesquisa do Estado de São Paulo name: Farmoquimica S.A. name: Hospital de Cancer de Barretos - Fundacao Pio XII briefSummary: The goal of this clinical trial is to identify the immunophenotypic profile of the local immune response, the cervicovaginal microenvironment and the microbiological profile of women with CIN 3 treated with imiquimod. Participants will be divided in 3 groups: CIN 3 who will use 16 doses of imiquimod in the uterine cervix, applied twice a week and will be treated with LEEP procedure; 2) patients with CIN 3 who will undergo standard treatment with LEEP procedure; 3) patients with negative cytology and HPV (human papillomavirus) test. Blood and cervicovaginal lavage collections will be performed at different times, for comparisons between cellular response profiles to imiquimod during treatment and baseline levels in healthy patients. conditions: HSIL, High-Grade Squamous Intraepithelial Lesions conditions: Vaginal Microbiome conditions: Biomarkers studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 96 type: ESTIMATED name: Imiquimod name: Loop Electrosurgical Excision Procedure measure: Number of participants with histological regression of High-grade squamous intraepithelial lesion (HSIL) measure: Identification of immune response in vaginal and plasma collection measure: Correlation between vaginal microbiome and immunological response sex: FEMALE minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06355999 id: 2007p000646-F briefTitle: Levari Exp.20: 2D - Partial Feedback overallStatus: COMPLETED date: 2021-05-01 date: 2021-06-01 date: 2021-06-01 date: 2024-04-10 date: 2024-04-10 name: Brigham and Women's Hospital class: OTHER briefSummary: Suppose that observers are trying to classify a spot on the skin as normal or abnormal and suppose that the two attributes that are important are the color and shape of the spot. The investigators have found that perceptual decisions of this short are shaped by the prevalence of the target abnormality and by the feedback that observers (Os) receive. If abnormal spots are rare (low prevalence), Os will tend to become more conservative about calling spots abnormal. In this experiment, Os see items defined by color and shape. They are looking for one combination (bumpy green). Bumpy green targets can be common (50% prevalence) or rare (10%). Os in one group will get feedback about their responses based on color. The other group will receive feedback based on shape. The investigators will look for effects of prevalence and of the type of feedback. The goal is to better understand perceptual decisions in settings like clinical evaluation of skin lesions. conditions: Form Perception conditions: Color Perception conditions: Decision Making studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups, each receiving different feedback primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Observers are naive as to the purpose of the experiment until after participation whoMasked: PARTICIPANT count: 55 type: ACTUAL name: Feedback measure: Participant naming of visual stimuli sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Visual Attention Lab / Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02215 country: United States lat: 42.35843 lon: -71.05977 hasResults: False
<\|newrecord\|> nctId: NCT06355986 id: 39039039AFL4016 briefTitle: Computerized Decision Support to Prevent Stroke in Atrial Fibrillation acronym: AF-ALERT3 overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-07-30 date: 2026-07-30 date: 2024-04-10 date: 2024-04-10 name: Brigham and Women's Hospital class: OTHER name: Janssen, LP briefSummary: Atrial fibrillation (AF) is the most preventable cause of stroke. However, despite widely available risk stratification tools, numerous options for oral anticoagulation, and evidence-based practice guidelines, anticoagulation for stroke prevention in AF is consistently under-prescribed. In a pair of observational cohort analyses within the Mass General Brigham (MGB) health system, prescription of anticoagulation for stroke prevention in AF was less frequent in ambulatory clinic patients than in those who were hospitalized at the time of assessment (46.9% vs. 57.2%). Two single academic medical center randomized controlled trials demonstrated success for increasing adherence to guideline recommendations for stroke prevention in AF. To address the feasibility and impact of a computerized decision support (CDS) strategy in the non-tertiary care, community medical center setting, this study will involve a multicenter, cluster-randomized controlled trial of a more sophisticated CDS focused not only on implementation stroke prevention but also on bleeding risk assessment and management. conditions: Atrial Fibrillation conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2500-patient U.S. multicenter, community-based Quality Improvement Initiative in the form of a cluster-randomized controlled trial. primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Assignment to a particular cluster (ALERT or NO ALERT) will be masked to the patient participant, investigator, and outcomes assessor. Since the intervention is a computer alert to the provider of record, he/she will be aware of whether or not a notification is provided. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 2500 type: ESTIMATED name: Alert-based computerized decision support measure: Frequency of prescription of anticoagulation at 90 days in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention at the time of study enrollment measure: Frequency of major bleeding at 6 months from enrollment. measure: Frequency of failure to prescribe anticoagulation because of perceived risk of bleeding in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation at the time of study enrollment and are assigned to the alert group measure: Frequency of a composite of major adverse cardiovascular events, defined as cerebrovascular accident, systemic embolism, any MI, symptomatic VTE, or all-cause mortality at 6 months from enrollment measure: Frequency of referral for left atrial appendage occlusion among patients with high bleeding risk at 6 months will be reported measure: Frequency of clinically relevant nonmajor bleeding is defined as overt bleeding not meeting the criteria for major bleeding at 6 months. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Elizabeth Health city: Edgewood state: Kentucky zip: 41017 country: United States name: Benjamin Peterson, MD role: CONTACT phone: 617-987-1046 email: benjamin.peterson@stelizabeth.com lat: 39.01867 lon: -84.58189 facility: Mass General Brigham city: Boston state: Massachusetts zip: 02115 country: United States name: Gregory Piazza, MD, MS role: CONTACT phone: 781-956-5525 email: gregorypiazza@hotmail.com lat: 42.35843 lon: -71.05977 hasResults: False
<\|newrecord\|> nctId: NCT06355973 id: 2024-01-061 briefTitle: A Pilot Study for Efficacy of Cognitive and Physical Training in Patients With Mild Cognitive Impairment overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12-31 date: 2024-12-31 date: 2024-04-10 date: 2024-04-10 name: MinYoung Kim, MD, PhD class: OTHER briefSummary: This is to find out the effectiveness of cognitive and physical function training for patients with mild cognitive impairment.
It is for the prevention and treatment of dementia in the future. randomized, Pilot Study. conditions: Patients With Mild Cognitive Impairment (MCI) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Using tablets and workbooks cognitive function. name: self-programming of physical function training. measure: Montreal Cognitive Assessment (MoCA) measure: Korean-Mini Mental Status Examination (K-MMSE) measure: Clinical Dementia Rating (CDR) measure: Clinical Global Impressions of Change (CGIC) measure: Instrumental Activities of Daily Living (I-ADL) measure: Berg Balance Scale (BBS) measure: Geriatric Quality of Life-Dementia (GQOL-D) measure: Geriatric Depression Scale (GDSd) measure: Global Deterioration Scale (GDS) measure: Electroencephalography sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06355960 id: 2024-853 briefTitle: Effect of Dexmedetomidine on Oxygenation and Lung Mechanics overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-05-01 date: 2024-04-10 date: 2024-04-10 name: Cairo University class: OTHER briefSummary: Dexmedetomidine is a selective α -2 agonist widely used in anesthesia for its sympatholytic, sedative and analgesic effects . Favorable respiratory effects in animals , and in selected human patient groups have been reported when using this agent .we investigated the effects of different doses of dexmedetomidine infusion on oxygenation conditions: Drug Use conditions: Dexmedetomidine studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 176 type: ESTIMATED name: GROUP Dexmedetomidine name: GROUP B name: GROUP C measure: Oxygenation by the end study measure: Intraoperative dynamic lung compliance measure: Intraoperative static lung compliance measure: Physiological dead space sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo university city: Cairo zip: 11562 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06355947 id: 103-7445B briefTitle: Cycling and Treadmill With Dual Task for Parkinson's Disease Improvement overallStatus: COMPLETED date: 2015-12-07 date: 2017-09-11 date: 2018-07-31 date: 2024-04-10 date: 2024-04-10 name: Chang Gung University class: OTHER briefSummary: Motor impairment in lower extremities is common in individuals with Parkinson disease (PD). Development sensitive test for early motor deviations is important. Conventional walking test cannot induce the PD related motor impairments, such as freezing of gait. Therefore, finding a safe substitute test to induce PD related motor impairments is important.
Studies showed that working memory related dual task walking was a sensitive test for PD. However, the optimal cognitive test needs to be clarified. Studies also showed that the neuromuscular control mechanism of leg movements during cycling were similar to those during walking. Therefore, dual task cycling test is potential to be a safe and sensitive testing model.
Studies showed that exercise could improve cognitive function and induce brain plasticity. Dual task exercise training was shown to be more effective than single task exercise training for older people to prevent fall. Whether the added cognitive task could improve to detriment brain plasticity in PD should be investigated. Transcranial magnetic stimulation can evaluate the motor cortex plasticity on-invasively and can evaluate the exercise induced brain plasticity.
The purpose of this three-year project is to develop PD-sensitive. The purposes of the first year are to translate the dual task walking test to dual task cycling test, and to establish the reliability of the dual task cycling test.
The purposes of the second year are to compare the motor cortex plasticity induced by single task cycling versus dual task cycling and to compare the difference response between PD and healthy control people.
The purpose of the third year is to evaluate the effect of 8 week long term cycling training or treadmill training of individuals with PD on motor cortex plasticity, dual task performance, and ambulation ability. conditions: Parkinson Disease(PD) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ACTUAL name: Cognitive cycling training name: Cognitive treadmill training measure: Walking Speed measure: Step Length measure: Step Time measure: Power Spectral Density (PSD) measure: Task Accuracy measure: Reaction Time measure: Balance Performance measure: Double Support Time measure: Single Support Time measure: Swing Time measure: Stance Time measure: Cadence measure: Heart rate sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chang Gung University city: Taoyuan zip: 333 country: Taiwan lat: 24.95233 lon: 121.20193 hasResults: False
<\|newrecord\|> nctId: NCT06355934 id: D8450R00004 briefTitle: OverTTuRe: Characteristics, Treatment Patterns and Outcomes of Patients With ATTR Amyloidosis acronym: OverTTuRe overallStatus: RECRUITING date: 2023-08-21 date: 2026-09-30 date: 2026-09-30 date: 2024-04-10 date: 2024-04-29 name: AstraZeneca class: INDUSTRY briefSummary: The overall aim of this observational study is to generate real-world evidence on the pre- and post-diagnosis disease journeys, including baseline characteristics, treatment patterns and selected clinical, economic, and humanistic outcomes (for example Health Related Quality of Life (HRQoL), Neuropathy impairment score, activities of daily living (ADL) assessments) in patients with ATTR amyloidosis, and to better understand how the disease is presented. conditions: ATTR Amyloidosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 55000 type: ESTIMATED name: no intervention measure: Health Care Resource Utilization (HCRU) - Outpatient visits measure: Health Care Resource Utilization (HCRU) - Outpatient visits by specialty measure: Health Care Resource Utilization (HCRU) - Emergency department visits measure: Health Care Resource Utilization (HCRU) - Hospitalizations, length of stay measure: Health Care Resource Utilization (HCRU) - Hospitalizations measure: Health Care Resource Utilization (HCRU) - Health care cost measure: Cardiac transplant measure: All cause mortality measure: Liver transplant measure: Heart Failure Hospitalization measure: New ATTR amyloidosis clinical manifestation measure: Hospitalization (any cause) measure: Neuropathy Impairment Score (NIS) measure: Neuropathy Impairment Score Lower Limbs (NIS-LL) measure: Neuropathy Impairment Score +7 (NIS+7) measure: Neuropathy Impairment Score modified +7 (mNIS+7) measure: Neuropathy symptoms and change (NCS) score measure: PND (Polyneuropathy Disability) measure: Other relevant clinical measurement of ATTR amyloidosis functional status measure: Norfolk Quality of Life - Diabetic Neuropathy (Norfolk QoL-DN) Score measure: Health Care Resource Utilization (HCRU) - Outpatient visits measure: Health Care Resource Utilization (HCRU) - Outpatient visits by specialty measure: Health Care Resource Utilization (HCRU) - Emergency department visits measure: Health Care Resource Utilization (HCRU) - Hospitalizations, length of stay measure: Health Care Resource Utilization (HCRU) - Hospitalizations measure: Health Care Resource Utilization (HCRU) - Health care cost sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: COMPLETED city: Eden Prairie state: Minnesota zip: 55344 country: United States lat: 44.85469 lon: -93.47079 facility: Research Site status: RECRUITING city: Horsens country: Denmark lat: 55.86066 lon: 9.85034 facility: Research Site status: COMPLETED city: Tokyo country: Japan lat: 35.6895 lon: 139.69171 facility: Research Site status: RECRUITING city: London country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
<\|newrecord\|> nctId: NCT06355921 id: RFAdesmoid briefTitle: A Prospective Clinical Study on the Safety and Efficacy of Radiofrequency Ablation for the Treatment of Patients With Desmoid Tumors acronym: RFAdesmoid overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-02-01 date: 2028-05-01 date: 2024-04-10 date: 2024-04-10 name: Blokhin's Russian Cancer Research Center class: OTHER briefSummary: This is a prospective study on the safety and effectiveness of radiofrequency ablation in patients with desmoid tumors.
In the study group, all patients after radiofrequency ablation of the tumor after 1 month will be evaluated using MRI and CT studies and, if solid components of the tumor are detected, repeated surgical treatment is performed followed by active monitoring after 1 month.
In the absence of a solid component, the effect is estimated by the volume of the necrotic process and monitored in dynamics every 3 months. conditions: Desmoid Tumor conditions: Desmoid Fibromatosis conditions: Desmoid studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: radiofrequency ablation measure: Comparison of safety assessment. measure: Overall Response Rate measure: Duration of responce measure: Comparison of tumor necrosis based on MRI/CT sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation (N.N. Blokhin NMRCO) city: Moscow state: MO zip: 115522 country: Russian Federation name: Artem Galustov role: CONTACT phone: 9169117818 email: artem115583@mail.ru name: Aslan Valiev, PhD role: PRINCIPAL_INVESTIGATOR name: Denis Sofronov, PhD role: SUB_INVESTIGATOR lat: 55.75222 lon: 37.61556 hasResults: False
<\|newrecord\|> nctId: NCT06355908 id: TT002 briefTitle: IL13Rα2 CAR-T for Patients With r/r Glioma acronym: ENHANCING overallStatus: RECRUITING date: 2024-03-21 date: 2026-05-01 date: 2027-05-01 date: 2024-04-10 date: 2024-04-10 name: Yang Zhang class: OTHER name: TCRCure Biopharma Ltd. briefSummary: This is a dose exploration clinical trial to assess the safety and feasibility of the IL13Ra2-targeted CAR-T in glioma. conditions: Glioma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: IL13Rα2 CAR-T measure: Safety of IL13Rα2 CAR-T measure: Overall Response Rate (ORR) measure: Duration of Response (DOR) measure: Progression Free Survival (PFS) measure: Overall Survival (OS) measure: Overall Survival (OS) at 6 months (OS6) measure: Overall Survival (OS) at 12 months (OS12) measure: The levels of IL13Rα2 CAR-T cell and IL13Rα2 CAR in the CSF and peripheral blood measure: The levels of cytokines in the CSF and peripheral blood measure: The Exploratory Indicators sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tiantan Hospital status: RECRUITING city: Beijing country: China name: Yang Zhang, MD, phD role: CONTACT phone: +861059976516 email: zhangyang8025@yeah.net lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06355895 id: HCC 23-104 briefTitle: Liver Volume Variation Effect on SBRT Planning and Delivery for Upper Abdominal Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-10 date: 2024-04-10 name: University of Pittsburgh class: OTHER name: American College of Radiation Oncology briefSummary: Standard planning constraints for liver SBRT incorporate strict dose-volume limits for normal liver parenchyma to minimize the risk of radiation-induced liver disease. The presence of diurnal and fasting/fed variations in liver volume therefore carry substantial potential for introducing errors into estimates of dose-volume distribution within normal liver tissue, as well as affecting day-to-day setup fidelity and organ alignment for treatment. This prospective study will examine how diurnal and fast-fed variations in liver volume affect treatment planning for abdominal SBRT. conditions: Upper Abdominal Malignancies studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 17 type: ESTIMATED name: Standardized high-carbohydrate meal measure: Diurnal Difference in Liver Volumes measure: Difference in total liver volume measure: Percentage diurnal difference in liver mean dose at V5 Gy measure: Percentage diurnal difference in liver mean dose at V15Gy measure: Difference in liver mean dose at V15 Gy measure: Difference in liver dose at V15 Gy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UPMC Hillman Cancer Center city: Pittsburgh state: Pennsylvania zip: 15232 country: United States name: Samantha Demko role: CONTACT name: Brieanna Marino role: CONTACT name: Susannah Ellsworth, MD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False
<\|newrecord\|> nctId: NCT06355882 id: LCOSDental briefTitle: Patients With Low Cardiac Output Syndrome Undergoing Local Dental Anesthesia overallStatus: RECRUITING date: 2023-08-08 date: 2024-12-01 date: 2024-12-01 date: 2024-04-10 date: 2024-04-22 name: University of Sao Paulo General Hospital class: OTHER name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. briefSummary: Patients with low cardiac output syndrome requiring surgical and periodontal dental treatment will be selected to undergo the dental procedure using local dental anesthetic: 2% lidocaine with epinephrine and 2% lidocaine without vasoconstrictor. Cardiovascular events and the safety of using two cartridges (3.6 mL) will be evaluated. They will be evaluated by Holter monitoring in the period of 1 hour before, during and 1 hour after the procedure and blood pressure correction will be performed conditions: Low Cardiac Output Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 29 type: ESTIMATED name: Anesthetic infiltration measure: Amount ventricular and supraventricular arrhythmia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto do Coração HCFMUSP status: RECRUITING city: São Paulo zip: 05403000 country: Brazil name: Itamara LI Neves, PhD role: CONTACT phone: 1126615229 email: itamara@incor.usp.br name: Mariana DC Dias role: CONTACT phone: 19996614440 email: mariana2497@gmail.com name: Itamara LI Neves, PhD role: PRINCIPAL_INVESTIGATOR lat: -23.5475 lon: -46.63611 hasResults: False
<\|newrecord\|> nctId: NCT06355869 id: s65337 briefTitle: Repeatability of Gait Deviations in Children With Cerebral Palsy overallStatus: COMPLETED date: 2021-08-17 date: 2023-05-31 date: 2023-05-31 date: 2024-04-10 date: 2024-04-15 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: Three-dimensional gait analysis (3DGA) is the 'gold standard' for measurement and description of gait. Gait variability can arise from intrinsic and extrinsic factors and may vary between walking conditions. This study aimed to define the inter-trial (intrinsic) and inter-session (extrinsic) repeatability in gait analysis data of children with CP who were walking in four conditions, namely barefoot or with ankle-foot orthosis, and overground or treadmill. conditions: Spastic Cerebral Palsy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 10 type: ACTUAL name: repeated 3D gait-analysis measure: The standard error of measurement (SEM) of the continuous kinematic gait waveforms measure: The intra-class correlation (ICC) of the gait indices measure: The standard error of measurement (SEM) of the continuous kinetic gait waveforms measure: The standard error of measurement (SEM) of the gait indices sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: UZ Leuven city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium lat: 50.87959 lon: 4.70093 hasResults: False
<\|newrecord\|> nctId: NCT06355856 id: ACH-PNT-04(01/22) briefTitle: Efficacy/ Safety of DNN.22.17.036 in Male Patients With Pattern Hair Loss acronym: CAPELLI overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2025-05 date: 2024-04-10 date: 2024-04-10 name: Ache Laboratorios Farmaceuticos S.A. class: INDUSTRY briefSummary: Evaluation of the efficacy and safety of DNN.22.17.036 versus 10573048700 in the treatment of male pattern hair loss. conditions: Alopecia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 196 type: ESTIMATED name: DNN.22.17.036 name: 10573048700 measure: Percentage variation of hairs in the hair loss phase sex: MALE minimumAge: 25 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06355843 id: SXY briefTitle: Clinical Applications of Integrated PET/MR and PET/CT in the Diagnosis and Treatment of Prostate Cancer. overallStatus: SUSPENDED date: 2022-04-28 date: 2023-09-30 date: 2027-03-31 date: 2024-04-09 date: 2024-04-09 name: The First Affiliated Hospital of Anhui Medical University class: OTHER name: National Natural Science Foundation of China briefSummary: The goal of this study type: observational study (prospective study) is to study prostate cancer occurrence and recurrence, to specifically identify and localize tumor foci at the molecular level at an early stage, to evaluate the prognosis of patients, and to accurately stage not only intermediate- and high-risk prostate cancer patients with a primary diagnosis, but also detect recurrent foci in patients with biochemical recurrence, to restage those who have developed metastases, to assess tumor load, and to ultimately assist in determining the personalized treatment plans. The main question it aims to answer is whether 68Ga-PSMA PET/CT (PET/MR) examination is beneficial for assessing the
* Accurate staging of patients with intermediate- and high-risk prostate cancer at first diagnosis;
* Detecting recurrent lesions in patients with recurrent tumors for re-staging;
* Assessment of tumor load;
* Assessment of patient prognosis. Participants will sign an informed consent form, undergo 68Ga-PSMA PET/CT (PET/MR) before surgery or biopsy, and have regular follow-up after obtaining pathological results of surgical resection or puncture biopsy, 6 weeks after surgery or biopsy, and then every 3 months; the follow-up will include: blood PSA, whole-body bone imaging, etc. conditions: Prostate Cancer conditions: Pet-ct studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: 68Ga-PSMA measure: Measuring the value of 68Ga-PSMA PET/MRI in the diagnosis and staging of primary prostate cancer and comparing it with mp-MRI and PET/CT measure: Exploring whether 68Ga-PSMA PET/MRI can be used as a method for diagnostic efficacy sex: MALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First affiliated hospital of anhui university city: Hefei state: Anhui zip: 230032 country: China lat: 31.86389 lon: 117.28083 hasResults: False
<\|newrecord\|> nctId: NCT06355830 id: RETimaging4iAMD briefTitle: Intermediate Age-related Macular Degeneration - Multimodal Analysis and Longitudinal Study acronym: Imaging4iAMD overallStatus: RECRUITING date: 2019-01-02 date: 2025-06 date: 2026-06 date: 2024-04-09 date: 2024-04-09 name: Universidade Nova de Lisboa class: OTHER name: iNOVA4Health, NOVA Medical School\|Faculdade de Ciências Médicas, NMS\|FCM, UNL name: Centro Hospitalar de Lisboa Central EPE, Lisboa, Portugal name: Centro Hospitalar Universitário de São João, Porto, Portugal briefSummary: Study: observational prospective clinical study. Study population: Subjects over 55 years old with drusen secondary to intermediate AMD.
Recruitment: at the Medical Retinal Consultation from the Ophthalmology Department of CHULC.
Primary outcome: Identifying imaging predictors of iAMD progression. conditions: Age-Related Macular Degeneration studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Orthoptic assessment (Outcome measure) measure: Change in incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) from baseline measure: Change in Drusen morphology from baseline measure: Change in Subfoveal drusen area from baseline measure: Change in other drusen area from baseline measure: Change in Drusen reflectivity from baseline measure: Change in other Drusen homogeneity from baseline measure: Change in ellipsoid zone disruption from baseline measure: Change in Drusen homogeneity from baseline measure: Change in hyperreflective foci from baseline measure: Change in hyperreflective foci location (within 500-μm disc area) from baseline measure: Change in hyperreflective foci association to drusen from baseline measure: Progression to Moderate Vision Loss measure: Geographic Atrophy (GA) Growth Rate measure: Progression to Advanced AMD according to international classification/grading system sex: ALL minimumAge: 55 Years maximumAge: 95 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ophthalmology Service, Centro Hospitalar de Lisboa Central EPE status: RECRUITING city: Lisbon zip: 1150-199 country: Portugal name: Rita Flores, MD role: CONTACT phone: 00351218841000 phoneExt: 21355 email: ritamariaflores@gmail.com lat: 38.71667 lon: -9.13333 hasResults: False
<\|newrecord\|> nctId: NCT06355817 id: HS25941 briefTitle: Distraction Techniques in Periocular Anesthesia: Tapping vs Vibration overallStatus: COMPLETED date: 2023-09-21 date: 2024-03-19 date: 2024-03-19 date: 2024-04-09 date: 2024-04-22 name: University of Manitoba class: OTHER name: Winnipeg Regional Health Authority briefSummary: To compare the efficacy of topical tapping vs vibration in lowering pain scores for periocular anesthesia injections. conditions: Anesthetics, Local conditions: Blepharoplasty conditions: Age-Related Ptosis conditions: Adult conditions: Humans conditions: Lidocaine conditions: Ophthalmologic Surgical Procedure conditions: Vibration conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Each patient will receive both interventions and serve as their own comparator. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The participant and surgeon was not made aware of which intervention the participant would receive first until the time of the procedure. Randomization was made at the time of the procedure. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 80 type: ACTUAL name: Vibration name: Tapping measure: Pain Reduction in Tapping vs Vibration distraction techniques in peri-ocular local anesthesia measure: Difference in Pain Reduction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Misericordia Health Centre city: Winnipeg state: Manitoba zip: R3C 1A2 country: Canada lat: 49.8844 lon: -97.14704 hasResults: False
<\|newrecord\|> nctId: NCT06355804 id: STUDY2023-1565 briefTitle: Lifestyle Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2025-04-22 date: 2025-04-22 date: 2024-04-09 date: 2024-04-09 name: University of Illinois at Chicago class: OTHER briefSummary: The overall objective of the current study is to determine the efficacy of a 16-week remotely delivered lifestyle behavioral intervention compared with a control condition (i.e., waitlist control) in persons newly diagnosed with MS (disease duration ≤ 2 years).
Specific Aim 1: To evaluate the changes in self-report and device-measured physical activity after the 16-week remotely delivered physical activity behavior change intervention compared with a control condition (i.e., waitlist control) in persons who have diagnosed with MS within the past two years. The investigators hypothesize that the 16-week behavior change intervention will yield greater improvements in physical activity levels than the control condition immediately after the intervention.
Specific Aim 2: To investigate the efficacy of the 16-week, remotely delivered physical activity behavior change intervention compared with the control condition for improvements in fatigue, depression, anxiety, and QoL in persons newly diagnosed with MS. The investigators hypothesize that there will be beneficial effects on the symptoms and QoL outcomes immediately after the physical activity intervention compared with minimal changes in the control condition. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: Physical activity condition name: Waitlist condition measure: Physical Activity Behavior measure: Physical Activity Behavior measure: Physical Activity Level (Light physical activity) measure: Physical Activity Level (Moderate-to-vigorous physical activity) measure: Physical Activity Level (Daily step count) measure: Health-related quality of Life measure: Health-related Quality of Life measure: Fatigue Severity measure: Depressive Symptoms measure: Anxiety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06355791 id: PDPROJ-4-TP-001-23 briefTitle: The Stability Study acronym: STABILITY overallStatus: ENROLLING_BY_INVITATION date: 2024-04-15 date: 2025-04-30 date: 2025-09-30 date: 2024-04-09 date: 2024-04-09 name: Spinal Simplicity LLC class: INDUSTRY briefSummary: The studied indication is degenerative conditions of the lumbar spine resulting in back pain with lower extremity symptoms and neurogenic claudication.
The purpose of this study is to evaluate the effectiveness and safety of instrumented posterior arthrodesis using the Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft material in patients with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication. conditions: Lumbar Spinal Stenosis conditions: Spondylolisthesis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 150 type: ESTIMATED name: Minuteman G5 measure: NRS Back and Leg measure: ODI measure: PROMIS 29 2.0 measure: 12 Month Fusion Assessment sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kansas University Medical Center city: Kansas City state: Kansas zip: 66160 country: United States lat: 39.11417 lon: -94.62746 hasResults: False
<\|newrecord\|> nctId: NCT06355778 id: HUM00234185 id: 1R01DA056415 type: NIH link: https://reporter.nih.gov/quickSearch/1R01DA056415 briefTitle: Adversity, Brain and Opioid Use Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-04 date: 2028-04 date: 2024-04-09 date: 2024-04-09 name: University of Michigan class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: The way people process and remember information may be related to adverse childhood experiences and Opioid Use Disorder symptoms. The purpose of this project is to examine brain function and performance during learning and memory tasks in adults. The study will compare measures of learning and memory across three groups of participants: those with an Opioid Use Disorder (OUD) that take buprenorphine for opioid replacement therapy, adults without an Opioid Use Disorder taking buprenorphine, and healthy adults that do not have an Opioid Use Disorder and are not taking buprenorphine. conditions: Opioid Use Disorder conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 315 type: ESTIMATED name: Magnetic Resonance Imaging (MRI) name: Computer Tasks measure: Differences in Blood Oxygen Level Dependent (BOLD) signal in the hippocampus measure: Differences in Hippocampal (Hpc) volume measure: Differences in hippocampal circuit connectivity measure: Differences in performance measure: Differences in performance measure: Differences in threat reactivity measured via skin conductance response (SCR) measure: Differences in threat reactivity measured via skin conductance response (SCR) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Mariya Churina role: CONTACT email: AdversityBrainOUD@med.umich.edu name: Elizabeth Duval, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False
<\|newrecord\|> nctId: NCT06355765 id: CITIZ_001 briefTitle: Citicoline & Antioxidants in Glaucoma overallStatus: COMPLETED date: 2022-01-10 date: 2022-12-10 date: 2022-12-10 date: 2024-04-09 date: 2024-04-17 name: University of Naples class: OTHER briefSummary: To evaluate the long-term effects of oral citicoline, vitamins A, B, C and E, and blackcurrant therapy in patients with primary open-angle glaucoma (POAG) using optical coherence tomography (OCT), OCT angiography (OCTA) and microperimetry parameters. conditions: Glaucoma, Open-Angle studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ACTUAL name: Citicoline blackcurrant supplement measure: Evaluation of Ganglionar cells complex (GCC) measure: Evaluation of Retinal nerve fiber layer (RNFL) sex: ALL minimumAge: 30 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Naples Federico II city: NAples zip: 80131 country: Italy lat: 40.85216 lon: 14.26811 hasResults: False
<\|newrecord\|> nctId: NCT06355752 id: 0018-N-23 briefTitle: Biomarkers of Pain and Stress Perception and Dry Needling Technique Application overallStatus: RECRUITING date: 2024-04-12 date: 2024-07-15 date: 2024-07-15 date: 2024-04-09 date: 2024-04-16 name: University of Alcala class: OTHER briefSummary: The use of the dry needling technique has become widespread in recent years for the treatment of musculoskeletal pain. Although dry needling has been shown to be effective in the treatment of shoulder pain, elbow pain, headache, etc., we do not yet have a clear understanding of the mechanisms of action that justify its beneficial effects.
In this study, we propose to analyse the biochemical markers of pain generated by the application of a dry needling technique on the lumbar musculature in patients with mechanical lumbar pain of non-specific origin.
The aim of this study will be to evaluate the effects of dry needling technique on the plasmatic concentration of biochemical markers.Furthermore, the test subjects will be randomly distributed into two groups.
An experimental group where the subjects will receive a real dry needling technique.
Another group will be treated with a sham technique. conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Dry needling of lumbar iliocostalis muscle name: Sham dry needling lumbar iliocostalis muscle measure: Extracting Blood Samples and Obtaining Serum/Plasma sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro Investigación Fisioterapia y Dolor status: RECRUITING city: Alcalá De Henares state: Madrid zip: 28805 country: Spain name: Patricia Martinez-Merinero, PhD role: CONTACT phone: 683378391 email: info@institutofisioterapiaydolor.es name: Laura Cabellos role: CONTACT phone: 683378391 email: clinica.fisio@fgua.es lat: 40.48205 lon: -3.35996 hasResults: False
<\|newrecord\|> nctId: NCT06355739 id: BIC-19GG, BIC-2019,BIC-2219 briefTitle: CD19-targeted CAR T Cell Autotransfusion for the Treatment of Recurrent/Refractory B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma in Children With CD19+ overallStatus: RECRUITING date: 2024-02-01 date: 2026-12-01 date: 2027-01-15 date: 2024-04-09 date: 2024-04-09 name: Zhu Xiaofan class: OTHER briefSummary: To evaluate the safety and efficacy of BIC-19GG, BIC-2019, BIC-2219 in the treatment of relapsed/refractory B acute lymphoblastic leukemia/lymphoblastic lymphoma in children conditions: B Lymphocytic Leukemia conditions: B Lymphoblastic Lymphoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: CAR T cell injection measure: Overall survival and event-free survival measure: Overall remission rate measure: Adverse events sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences status: RECRUITING city: Tianjin state: Tianjin zip: 300020 country: China name: Xiaofan Zhu, MD role: CONTACT phone: 86-21-23909001 email: xfzhu@ihcams.ac.cn name: Jingliao Zhang, MD role: SUB_INVESTIGATOR lat: 39.14222 lon: 117.17667 facility: InstituteHBDH status: NOT_YET_RECRUITING city: Tianjin state: Tianjin zip: 300020 country: China name: Zhu Xiaofan role: CONTACT phone: 86-21-23909001 email: xfzhu@ihcams.ac.cn name: Guo Ye role: PRINCIPAL_INVESTIGATOR name: Yang Wenyu role: PRINCIPAL_INVESTIGATOR name: Chen Xiaojuan role: PRINCIPAL_INVESTIGATOR name: Chen Yumei role: PRINCIPAL_INVESTIGATOR name: Ruan Min role: PRINCIPAL_INVESTIGATOR lat: 39.14222 lon: 117.17667 hasResults: False
<\|newrecord\|> nctId: NCT06355726 id: ILBS-Alcoholic Hepatitis-03 briefTitle: Efficacy of Plasma Exchange Therapy vs Standard Medical Therapy in Severe Alcoholic Hepatitis With High Discriminant Function overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-02-28 date: 2025-02-28 date: 2024-04-09 date: 2024-04-09 name: Institute of Liver and Biliary Sciences, India class: OTHER briefSummary: Alcoholic hepatitis, the most florid form of alcoholic liver disease, has a very high short-term mortality of up to 50% and no specific therapies are available other than steroids. Steroids also only show a limited utility in improving the short-term survival and boast no evidence of any long-term benefits. Additionally, only a small proportion of patients with alcoholic hepatitis are eligible to receive steroids. Thus, a large number of patients are either not eligible or do not respond to steroids and this group outnumbers those who do respond to steroids, leaving us without any specific therapeutic options for a majority of these individuals.\[1\] Even liver transplantation is not feasible in most cases due to the presence of sepsis or recent alcohol consumption and many ethical and logistic issues are involved despite the documented safety and survival benefits of early liver transplantation in patients with severe alcoholic hepatitis (SAH) not responding to medical management.\[2,8\] Therefore, newer, more effective, and nontransplant therapeutic options for managing severe alcoholic hepatitis are needed. TPE is expected to be an effective and well-tolerated bridge therapy in patients with severe alcoholic hepatitis of moderate severity not improving on SMT and without immediate prospects for liver transplantation. conditions: Alcoholic Hepatitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Plasma Exchange name: Standard Medical Treatment measure: Liver transplant free survival at 28 days, 90 days and 180 days. measure: Change in total bilirubin and INR as measured by Discriminant Functions measure: Number of patients with change in Model for End Stage Liver Disease (MELD) measure: Number of patients with change in CTP measure: Number of patients with change in LSM,SSM measure: Mortality in both groups measure: clinical improvement in the form of jaundice as measured by total bilirubin measure: clinical improvement in the form of hepatic encephalopathy as measured by west haven criteria measure: clinical improvement in the form of ascites as measured by ICA criteria. measure: Frequency of decompensation events on follow up period measure: Adverse events during plasma exchange sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Institute of Liver & Biliary Sciences (ILBS) city: New Delhi state: Delhi zip: 110070 country: India lat: 28.63576 lon: 77.22445 hasResults: False
<\|newrecord\|> nctId: NCT06355713 id: 69HCL23_0899 id: 2023-A02010-45 type: OTHER domain: ID-RCB briefTitle: Improvement of Symptoms After Removal of the Essure® Contraceptive Implant acronym: ABLES overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2031-08-01 date: 2036-06-01 date: 2024-04-09 date: 2024-04-09 name: Hospices Civils de Lyon class: OTHER briefSummary: ESSURE® is an implantable medical device for definitive and irreversible sterilization indicated for adult women of childbearing age. These implants are inserted into the fallopian tubes by hysteroscopy. Marketed in 2002, ESSURE® contraceptive implants were withdrawn from the French market in 2017 (and worldwide in 2017 and 2018) following the observation in certain patients of polymorphic and non-specific gynecological and extra-gynecological symptoms. Studies with small numbers and short-term follow-up have shown a significant improvement in these symptoms after implant explantation. This constitutes a real public health problem since according to the report of the EPI-PHARE Scientific Interest Group, 198,000 French women have these implants and only 30,000 of them, or 15%, have been explanted, knowing that explantation of ESSURE® implants is recommended only in symptomatic patients. A large number of these patients, presenting symptoms, have not yet been treated for an explant.
The physiopathological mechanism(s) is (are) not yet determined but several arguments are in favor of a dissemination of metallic elements contained in these implants whose accumulation could lead to inflammatory and/or allergic and/or autoimmune phenomena.
Carrying out a prospective study with long-term longitudinal follow-up appears essential to precisely assess the degree of improvement in the symptoms and quality of life of these patients, determine the most appropriate surgical techniques, and understand the pathophysiological mechanisms that may result in the implementation of specific treatments and relevant markers. From a surgical point of view, there is a real risk of fracture of implants whatever the type of intervention performed: study the biomechanical properties of implants with a view to characterizing their behavior to mechanical rupture but also their thermal resistance in an objective manner seems essential to limit the risk of fracture and help to inform the patient about the surgical technique proposed for explantation. From a biological point of view, the dosage of the metallic elements constituting ESSURE® implants and potentially toxic ones could make it possible to objectify the release of these metallic elements in the body. Analysis of pro-inflammatory cytokines, micro-RNAs (miRNA), quantitative analysis of inflammatory pathway messenger ribonucleic acid (mRNAs) (NanoString technology) and analysis of neuroinflammation by functional imaging should make it possible to explore potential pathophysiological mechanisms. This study responds to a significant request from patient associations. conditions: Implant Complication conditions: Contraceptive Device; Complications studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 444 type: ESTIMATED name: Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examination name: blood sample name: urine collection name: Collection of a lock of hair name: questionnaire measure: Percentage of patients with improvement in symptoms Percentage of patients with improvement in symptoms measure: Percentage of patients with improvement in symptoms measure: Short Form 12 (SF-12) score measure: Fibromyalgia Impact Questionnaire (FIQ) score measure: Hospital Anxiety and Depression scale (HADS) score measure: Multidimensional Fatigue Inventory (MFI)-20 score measure: Visual analog scale (VAS) score measure: Questionnaire Douleur St-Antoine (QDSA) score measure: Female Sexual Function Index (FSFI) score measure: Higham questionnaires measure: visual analog scale (VAS) score measure: Duration of the procedure measure: Complications measure: characterization of the mechanical behavior of the implant measure: determination of the associated mechanical stress levels determination of the associated mechanical stress levels measure: quantification of the factors influencing these levels of mechanical stress measure: thermal resistance measure: risk of degradation measure: Concentrations of titanium constituting the Essure® implant measure: Concentrations of nickel constituting the Essure® implant measure: Concentrations of chromium constituting the Essure® implant measure: Concentrations of tin constituting the Essure® implant measure: Concentrations of platinum constituting the Essure® implant measure: Concentrations of iridium constituting the Essure® implant measure: Concentrations of molybdenum constituting the Essure® implant measure: Concentrations of manganese constituting the Essure® implant measure: Concentrations of tungsten constituting the Essure® implant measure: Concentrations of silver constituting the Essure® implant measure: Concentrations of iron constituting the Essure® implant measure: concentration of pro-inflammatory cytokines measure: expression profile of miRNAs measure: activated T lymphocyte profile measure: analysis of inflammatory pathway mRNAs measure: Percentage of detection of Human Leukocyte Antigen measure: Functional brain functions sex: FEMALE minimumAge: 35 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Angers city: Angers zip: 49933 country: France name: Guillaume Legendre, PU,PH role: CONTACT phone: 0241354635 phoneExt: +33 email: guillaume.legendre@chu-angers.fr name: Guillaume Legendre, PU,PH role: PRINCIPAL_INVESTIGATOR lat: 47.46667 lon: -0.55 facility: Hôpital Femme Mère Enfant (Hospices Civils de Lyon) city: Bron zip: 69677 country: France name: Gautier Chene, PU,PH role: CONTACT phone: 0472355870 phoneExt: +33 email: gautier.chene@chu-lyon.fr name: Gautier Chene, PU,PH role: PRINCIPAL_INVESTIGATOR lat: 45.73333 lon: 4.91667 facility: Hôpital Bicêtre city: Le Kremlin-Bicêtre zip: 94275 country: France name: Perrine CAPMAS, PU,PH role: CONTACT phone: 0145217714 phoneExt: +33 email: perrine.capmas@aphp.fr name: Perrine CAPMAS, PU,PH role: PRINCIPAL_INVESTIGATOR lat: 48.81471 lon: 2.36073 facility: Hôpital Jeanne de Flandres city: Lille zip: 59037 country: France name: Victoire Delporte, PU,PH role: CONTACT phone: 0320446641 phoneExt: +33 email: victoire.delporte@chu-lille.fr name: Victoire Delporte, PU,PH role: PRINCIPAL_INVESTIGATOR lat: 50.63297 lon: 3.05858 facility: Hôpital de La Conception city: Marseille zip: 13005 country: France name: Aubert Agostini, PU,PH role: CONTACT phone: 0491383702 phoneExt: +33 email: Aubert.AGOSTINI@ap-hm.fr name: Aubert Agostini, PU,PH role: PRINCIPAL_INVESTIGATOR lat: 43.29551 lon: 5.38958 facility: Institut Mère Enfant Alix de Champagne, CHU Reims city: Reims zip: 51092 country: France name: Olivier Graesslin, PU,PH role: CONTACT phone: 0326783517 phoneExt: +33 email: ograesslin@chu-reims.fr name: Olivier Graesslin, PU,PH role: PRINCIPAL_INVESTIGATOR lat: 49.25 lon: 4.03333 facility: CHU de Rouen city: Rouen zip: 76000 country: France name: Patrice Crochet, PU,PH role: CONTACT phone: 0232881054 phoneExt: +33 email: patrice.crochet@chu-rouen.fr name: Patrice Crochet, PU,PH role: PRINCIPAL_INVESTIGATOR lat: 49.44313 lon: 1.09932 facility: Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg city: Strasbourg zip: 67200 country: France name: Thomas Boisrame, PU,PH role: CONTACT phone: 0388127458 phoneExt: +33 email: thomas.boisrame@chru-strasbourg.fr name: Thomas Boisrame, PU,PH role: PRINCIPAL_INVESTIGATOR lat: 48.58392 lon: 7.74553 facility: Hôpital Paule de Viguier, CHU de Toulouse city: Toulouse zip: 31059 country: France name: Yann Tanguy Le Gac, PU,PH role: CONTACT phone: 0567771105 phoneExt: +33 email: tanguylegac.y@chu-toulouse.fr name: Yann Tanguy Le Gac, PU,PH role: PRINCIPAL_INVESTIGATOR lat: 43.60426 lon: 1.44367 facility: Hôpital André Mignot, Centre Hospitalier de Versailles city: Versailles zip: 78157 country: France name: Pierre Panel, PU,PH role: CONTACT phone: 0139638936 phoneExt: +33 email: ppanel@ch-versailles.fr name: Pierre Panel, PU,PH role: PRINCIPAL_INVESTIGATOR lat: 48.8 lon: 2.13333 hasResults: False
<\|newrecord\|> nctId: NCT06355700 id: 5476 briefTitle: Hepatocellular Carcinoma Liver Organoids acronym: HELIO overallStatus: RECRUITING date: 2023-06-15 date: 2025-03 date: 2025-03 date: 2024-04-09 date: 2024-04-09 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The goal of this interventional study is to create hepatocellular carcinoma organoids from liver bioptic samples of individuals with hepatocellular carcinoma. The main questions it aims to answer are:
* the feasibility of hepatocellular carcinoma organoids integrated with host gut microbiota and peripheral blood mononuclear cells
* the molecular pattern of the organoid tumor microenvironment
* the in vitro therapeutic response of hepatocellular carcinoma organoids conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 10 type: ESTIMATED name: Liver biopsy measure: Success rate of hepatocellular carcinoma organoids integrated with host gut microbiota and peripheral blood mononuclear cells measure: Analysis of hepatocellular carcinoma organoid transcriptome distribution within a reference set from The Cancer Genome Atlas measure: Evaluation of the concordance of somatic genetic mutations between the organoid and the original tumor measure: Correlation between gut microbiota community profiling and growth rate of hepatocellular carcinoma organoids measure: Treatment response evaluation in vitro sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Agostino Gemelli IRCCS status: RECRUITING city: Roma zip: 00168 country: Italy name: Francesca Ponziani, MD role: CONTACT phone: +390630156018 email: comitato.etico@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False
<\|newrecord\|> nctId: NCT06355687 id: FMASU MD304/2023 briefTitle: Melatonin in Obese Patients in Laparoscopic Cholecystectomy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-09 date: 2024-04-09 name: Ain Shams University class: OTHER briefSummary: Opioid free anesthesia (OFA) means a technique in which no intraoperative opioid is administered through any route. Perioperative pain management in an obese patient is challenging. The incidence of respiratory depression is higher in obese patients and is exaggerated with opioids, so the investigators are searching for a drug that has analgesic effect without any effect on respiratory function. In this study, the investigators will add melatonin to OFA in obese patients undergoing laparoscopic cholecystectomy. conditions: Anesthesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 60 type: ESTIMATED name: Melatonin name: Vitamin Supplement measure: Postoperative Pain. measure: Postoperative Pain. measure: Analgesics usage. measure: Postoperative nausea and vomiting. measure: Recovery time. measure: Number of participants with hemodynamic instability. measure: Number of participants with hemodynamic instability. sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06355674 id: HRÜ/23.21.12 briefTitle: Adolescent Mother and Breastfeeding Education overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-09-15 date: 2024-10-15 date: 2024-04-09 date: 2024-04-09 name: Adiyaman University class: OTHER briefSummary: In low-income and developing countries, 30% of adolescents marry before the age of 18, and 14% marry before the age of 15. Additionally, adolescents between the ages of 15 and 19 are often coerced into marriage or sexual relationships with partners older than themselves. 10% of adolescents under the age of 15 in the world are forced to have sexual intercourse and as a result, unwanted teenage pregnancies occur. In high-income countries like Latin America, there is a high prevalence of adolescent non-marital pregnancies. When considering the fertility, health, and social outcomes of adolescence, it emerges as a significant issue. Adolescent motherhood carries numerous adverse effects from both demographic and social perspectives.
In pregnancies occurring during adolescence, both maternal and infant mortality rates are two to three times higher compared to pregnancies at later ages. Many infant and child deaths occur due to preventable causes. Breastfeeding is a significant factor in reducing infant and child mortality. Since infants born to adolescent mothers are at higher risk of death and illness, breastfeeding these infants becomes even more important. However, one of the significant challenges adolescent mothers face during the postpartum period is initiating and maintaining lactation. Research has shown that maternal age plays a significant role in initiating and sustaining breastfeeding, with a strong positive correlation between maternal age and duration of breastfeeding. This study was designed as a randomized controlled trial to examine the effect of breastfeeding education provided to adolescent mothers on maternal breastfeeding self-efficacy, mother-infant attachment, and infant anthropometric measurements. conditions: Adolescent Mother studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 80 type: ESTIMATED name: Breastfeeding education provided with Lactation Simulation Model measure: Postnatal Breastfeeding Self-Efficacy Scale-Short Form measure: Maternal-Infant Attachment Scale sex: FEMALE minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06355661 id: HP/231102/PA/URTI briefTitle: A Study for Assessing the Efficacy and Safety ParActin® in Individuals With Upper Respiratory Tract Infections overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-05-15 date: 2024-06-01 date: 2024-04-09 date: 2024-04-09 name: Vedic Lifesciences Pvt. Ltd. class: INDUSTRY briefSummary: The present study is a randomized, double-blind, placebo-controlled, comparative study. 176 individuals will be screened, and considering a screening failure rate of 15 percent approximately 150 will be randomized in a ratio of 1:1 to receive either IP or placebo and will be assigned a unique randomization code. Each group will have at least 60 completed participants after accounting for a dropout/withdrawal rate of 20percent. The intervention duration for all the study participants is 7 days conditions: Upper Respiratory Tract Infections studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Double-blind, Randomized, Placebo-Controlled primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: ParActin®: 300 mg + MCC: 100 mg (± 10%) per Capsule name: MCC: 400 mg (± 10%) per Capsule measure: To evaluate the effect of investigational products on participant's severity of common cold like symptoms measure: To evaluate the effect of investigational products on Time (in days) taken to resolution of common cold like symptoms measure: To evaluate the effect of investigational products on Percentage of participants with unresolved common cold symptoms measure: To evaluate the effect of investigational products on Percentage of population with minimal important difference of ≥ 10.3 as per change in Wisconsin Upper Respiratory Symptom Survey-21 total score. (daily score will be analysed in study) measure: To evaluate the effect of investigational products on Number of days taken to be afebrile (temp < 100 oF/< 37.7 ºC) in the population with fever (temp ≥100oF or ≥37.7 ºC ) at baseline- as assessed by 10-point visual analogue scale. measure: To evaluate the effect of investigational products on Percentage population with fever during the study. measure: To evaluate the effect of investigational products on Quality of life as assessed by Wisconsin Upper Respiratory Symptom Survey Quality of Life sex: ALL minimumAge: 16 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Biswas health care & Diagnostic Centre city: Nainital state: Uttaranchal country: India name: Dr Bijay Biswas, MBBS,MD role: CONTACT phone: 919760010003 email: biswasclinic058@gmail.com lat: 29.39743 lon: 79.44686 hasResults: False
<\|newrecord\|> nctId: NCT06355648 id: IRAS 337181 briefTitle: Advanced Clinical Practitioners in the ED overallStatus: NOT_YET_RECRUITING date: 2024-05-03 date: 2024-10-01 date: 2025-03-01 date: 2024-04-09 date: 2024-04-09 name: King's College London class: OTHER briefSummary: No patient data is involved in the study. This study is designed to understand better how Emergency Care Advanced Clinical Practitioners (EC-ACPs) work in emergency departments (EDs). The main research question is:
1) What is the EC-ACP's perception of assimilation into emergency care teams, what tensions are created due to the role, and what system adaptations are required to facilitate integration?
With secondary aims :
1. What are the common organisational factors that affect the implementation of the EC-ACP workforce, and what recommendations can be made to improve Trust-wide implementation?
2. How are EC-ACPs deployed in two contrasting emergency departments, what differences can be identified in their Work-As-Done (WAD), and how does this compare to the Work-As-Imagined (WAI) of the role?
Participants will all be staff members who work in the hospital. Patient data is not being collected or processed. This is a mixed-method study using two approaches to collect data:
1. Observation of the EC-ACPs at work - noting how they interact with colleagues and how they are deployed in the ED.
2. Interviews with various staff who work with the EC-ACPs clinically or in various managerial or director roles.
Background
In the UK, a health care role has been developed called Advanced Clinical Practitioners (ACPs). ACPs work in various clinical settings, but this study focuses on those in Emergency Care. While non-medical practitioners have worked in Emergency Departments (EDs) for over 20 years, the ACP role is relatively new. Most ACPs in ED are from a nursing or paramedical background, but they can also be from other allied health professions like physiotherapy. After the base qualification, ACPs undertake a three-year master\'s degree with clinical portfolios. Once qualified, the goal is to create clinicians who work alongside doctors, seeing, treating, and discharging patients. Unlike previous practitioner roles, EC-ACPs treat the whole spectrum of ED patients, from minor injuries and illnesses to the sickest patients needing the highest level of care.
These roles were heavily supported by local and political desires to create blended workforces to meet increasing patient demands. The problem with implementing ACP roles is that initially, little consultation was held with stakeholders in EDs. This has resulted in various trade-offs. For example, trainee doctors often feel displaced by trainee ACPs seeking to learn the same or similar skills.
Previous research on advanced roles in ED has focused on direct clinical comparisons between doctors and practitioners. Researchers have investigated which professional (doctors vs. nurse practitioners) triages patients quickest or who is more accurate at interpreting X-rays. There are several problems with these approaches. The first is that they can create a professional rivalry. The second problem is that these approaches oversimplify what is a more complex system of care. conditions: Healthy Volunteers studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Narrative data measure: Narrative data sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06355635 id: JohannesGUVA briefTitle: Application and Monitoring of Vasoactive and Inotrope Drugs acronym: Vasin overallStatus: RECRUITING date: 2024-04-04 date: 2024-06-01 date: 2024-11-01 date: 2024-04-09 date: 2024-04-09 name: Johannes Gutenberg University Mainz class: OTHER briefSummary: The investigators aimed to establish current practice of application and monitoring of vasoactive and inotrope Drugs in non-cardiac surgery patients. conditions: Hemodynamic Instability studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Choice and Monitoring measure: current practice of correct application and monitoring of vasoactive and inotrope Drugs sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Anaesthesiology; status: RECRUITING city: Mainz state: Rhineland-Palatinate zip: D55131 country: Germany name: Marc Kriege, MD role: CONTACT phone: 00496131170 email: MaKriege@uni-mainz.de lat: 49.98419 lon: 8.2791 hasResults: False
<\|newrecord\|> nctId: NCT06355622 id: 3717 briefTitle: Prevalence and Characterization of Pain in RASopathies acronym: 3717 overallStatus: RECRUITING date: 2021-01-27 date: 2024-01-30 date: 2024-06-30 date: 2024-04-09 date: 2024-04-09 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: RASopathies are a group of syndromes caused by variants in genes belonging to the RAS/MAPK pathway. Pain is a neglected topic in RASopathies but it is frequently complained by affected individuals. conditions: RASopathy conditions: Costello Syndrome conditions: Cardio-Facio-Cutaneous Syndrome conditions: Noonan Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 150 type: ESTIMATED name: Characterization of pain measure: Prevalence of pain in verbal patients with RASopathies measure: Prevalence of Pain in no-communitating patients with RASopathies measure: Characterization of pain in RASopathies sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Woman and Child Health and Public Health, Fondazione Policlinico A. Gemelli, IRCCS status: RECRUITING city: Roma zip: 00168 country: Italy name: Chiara Leoni, MD, PhD role: CONTACT phone: 0039063381344 email: chiara.leoni@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False
<\|newrecord\|> nctId: NCT06355609 id: DZ2023EI004-RW briefTitle: Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR Mutant Advanced NSCLC-RW acronym: WUKONG-32-RW overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-12-30 date: 2027-12-30 date: 2024-04-09 date: 2024-04-09 name: Hunan Province Tumor Hospital class: OTHER briefSummary: This is a phase II, open-label, single-arm, single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with EGFR-sensitive mutations and co-mutations in locally advanced or metastatic treatment-naive non-small cell lung cancer. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: sunvozertinib in combination with Anlotinib measure: Progression-free survival (PFS) measure: Objective Response Rate (ORR) measure: Overall survival (OS) measure: Duration of Response (DoR) measure: Adverse events (AEs) according to CTCAE 5.0 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hunan Cancer Hospital city: Changsha state: Hunan zip: 410013 country: China lat: 28.19874 lon: 112.97087 hasResults: False
<\|newrecord\|> nctId: NCT06355596 id: 20IC6361 briefTitle: Development and Validation of a Virtual Teaching Method for Minimally Invasive Surgery Skills overallStatus: COMPLETED date: 2022-03-11 date: 2022-04-08 date: 2022-04-08 date: 2024-04-09 date: 2024-04-09 name: Imperial College London class: OTHER briefSummary: The goal of this observational study is to develop and evaluate a virtual teaching method for minimally invasive surgery (MIS) skills among novice learners, using widely available technology and incorporating objective assessments of proficiency. The main questions it aims to answer are:
Can MIS skills be effectively taught to novice learners through a virtual platform using widely available technology? How do virtual and face-to-face (F2F) teaching methods compare in terms of effectiveness, measured by performance in MIS tasks and cognitive workload parameters?
Participants in this study will:
Be randomly allocated to either F2F or virtual teaching groups. Undergo training and evaluation using validated laparoscopic assessments, namely the McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) peg transfer task and the European Academy laparoscopic 'Suturing Training and Testing' (SUTT) assessment.
Have their performance and cognitive workload parameters (SURG-TLX score, heart rate, and pupil metrics) evaluated during the tasks. conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Participants are randomly allocated to either face-to-face or virtual teaching groups primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ACTUAL name: Virtual teaching measure: McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) peg transfer task score measure: European Academy laparoscopic 'Suturing Training and Testing' (SUTT) assessment score measure: SURG-TLX score measure: Heart rate measure: Pupil metrics sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St Mary's Hospital city: London zip: W2 1NY country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
<\|newrecord\|> nctId: NCT06355583 id: C/42/2022 id: 2022-003617-10 type: EUDRACT_NUMBER briefTitle: Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial acronym: MAST overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-02-01 date: 2027-05-01 date: 2024-04-09 date: 2024-04-09 name: Imperial College London class: OTHER briefSummary: The goal of this clinical trial is to test the ability to restore gut microbiota to healthier levels in patients with blood cancers scheduled to have stem cell transplant.
The main questions it aims to answer are:
* Tolerability and acceptability of intestinal microbiota transplantation (IMT) versus placebo (as assessed via patient perspective questionnaires
* Changes in gut microbiome diversity across all timepoints
* Markers of general health, infective/microbiological and haematological outcomes including, days of fever, admission to intensive care unit, survival, non-relapsed mortality, and incidence of graft-versus-host disease across all time points measured.
Participants will be asked at their routine follow up visits to,
* Provide stool, urine and blood samples at the scheduled study visits
* Complete questionnaires at selected visits
* Swallow either Placebo or IMT capsules once at the second study visit which will occur 2 weeks prior to the stem cell transplant (+/-3 days)
Researchers will compare IMT capsules and Placebo to investigate the change in gut microbiota diversity. conditions: Acute Lymphoblastic Leukaemia conditions: Acute Leukemia of Ambiguous Lineage conditions: Chronic Myeloid Leukemia conditions: Chronic Myelomonocytic Leukemia conditions: Myelodysplastic Syndrome conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: EBX-102 name: Placebo measure: Change in gut microbiota diversity using Inverse Simpsons Index measure: Gut Microbiome Diversity - Alpha diversity measure: Alpha Diversity - Chao1 Index measure: Alpha Diversity - Shannon Index measure: Alpha Diversity - Faiths Phylogenetic Diversity (Faiths PD) measure: Beta Diversity - Aitchison Distance measure: Gut Microbiome Taxonomic Composition measure: Markers of general health - ITU Admission measure: Quality of life EQ-5D-5L measure: Quality of Life EORTC-QLQ-C30 measure: Infective Haematological Outcomes - Fever Occurrence measure: Infective Haematological Outcomes - Fever CTCAE Grade measure: Infective Haematological Outcomes - Infection measure: Infective Haematological Outcomes - Multi drug Resistant Bacterial Colonisation (MDROs) measure: Infective Haematological Outcomes - Antibiotic Use measure: Markers of General Health - Severity of Mucositis measure: Markers of General Health -Occurrence of Severe Acute Kidney Injury (AKI) measure: Markers of General Health - Occurrence of Severe liver dysfunction measure: Markers of general health - Use of Parenteral Nutrition measure: Neutrophil and platelet engraftment data measure: Recovery of T-cell Chimaerisms, measure: Haematological Outcomes - Non-relapsed mortality measure: Haematological Outcomes - Occurrence Graft vs Host Disease measure: Haematological Outcomes - Severity of graft vs Host Disease measure: Overall Survival measure: Graft-versus disease-free relapse-free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals Birmingham NHS Foundation Trust city: Birmingham state: England zip: B15 2WB country: United Kingdom name: Senior Haematology Research Sister role: CONTACT phone: 01213714351 email: HaematologyCancerResearch@uhb.nhs.uk name: Francesca Kinsella role: PRINCIPAL_INVESTIGATOR lat: 52.48142 lon: -1.89983 facility: Leeds Teaching Hospital NHS Trust city: Leeds state: England zip: LS9 7TF country: United Kingdom name: Principal Investigator role: CONTACT phone: 01132068561 email: anjum.khan@nhs.net lat: 53.79648 lon: -1.54785 facility: University College London Hospitals NHS Trust city: London state: England zip: NW1 2BU country: United Kingdom name: BMT Trials role: CONTACT email: uclh.bmttrials@nhs.net name: Panagiotis Kottaridis role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Kings College NHS Foundation Trust city: London state: England zip: SE5 9RS country: United Kingdom name: Principal Investigator role: CONTACT email: p.krishnamurthy@nhs.net name: Pramila Krishnamurthy role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Imperial College Healthcare NHS Trust city: London state: England zip: W12 0NN country: United Kingdom name: Senior Research Operations Manager role: CONTACT phone: 02037048452 email: Eleni.Vourvou@nhs.net lat: 51.50853 lon: -0.12574 facility: Royal Mardsen Hostpital city: London zip: SW3 6JJ country: United Kingdom name: Haemato-Oncology Department role: CONTACT phone: 0208915 6187 email: Emma.Nicholson@rmh.nhs.uk name: Emma Nicholson role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 hasResults: False
<\|newrecord\|> nctId: NCT06355570 id: 331314 id: RFPR2324_29 type: OTHER_GRANT domain: Imperial Health Charity id: 24/YH/0011 type: OTHER domain: UK Health Research Authority (Research Ethics Committee) briefTitle: Delirium After Cardiac Surgery in Intensive Care Units acronym: DaCsi-ICU overallStatus: RECRUITING date: 2024-03-20 date: 2024-12-31 date: 2025-03-20 date: 2024-04-09 date: 2024-04-11 name: Imperial College Healthcare NHS Trust class: OTHER briefSummary: STUDY SUMMARY
STUDY DESIGN The study will be conducted over twelve months in the Cardiac Intensive Care Unit (ICU) at Hammersmith Hospital, Imperial College Healthcare NHS Trust (ICHT). This study is a mixed methods research design that includes the collection of data through qualitative interviews, quality-of-life questionnaires and patients' medical records.
AIMS
* Determine the incidence of ICU delirium in ICHT following cardiac surgery
* Explore the compliance of outcome measures that diagnose ICU delirium
* Implement a family-focused sensory stimulation programme in the ICU
* Evaluate its useability and potential impact on patients, families and ICU staff
STUDY POPULATION 30 study participants (12 patients, 12 family members/friends and 6 ICU nurses)
ELIGIBILITY Study eligibility criteria are specific for each care group (patients, family members/friends and ICU nurses).
DURATION 12 months at Hammersmith Hospital, ICHT conditions: Intensive Care Unit Delirium conditions: Cardiac Surgery conditions: Post Operative Delirium studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 12-patient participants will be submitted to the study intervention. primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ESTIMATED name: Personal Pictures name: Family Videos name: Family Videos - Intervention as required measure: Feasibility of implementing the study intervention measure: Practicalities of introducing the study intervention measure: Acceptability of implementing the study intervention measure: Short-term delirium outcomes post-ICU discharge sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Imperial College Healthcare NHS Trust status: RECRUITING city: London zip: W12 0HS country: United Kingdom name: Maria Reguenga, BSN role: CONTACT phone: +442033131703 email: maria.reguenga@nhs.net name: Sanooj Soni, PhD role: CONTACT phone: 07714329708 email: sanooj.soni@nhs.net lat: 51.50853 lon: -0.12574 hasResults: False
<\|newrecord\|> nctId: NCT06355557 id: DSRB 2023/00640 briefTitle: Human vs Machine: a RCT Comparing Traditional In-person Instruction, AI Versus VR for Learning Basic CCE overallStatus: RECRUITING date: 2024-04-04 date: 2024-12-31 date: 2025-01 date: 2024-04-09 date: 2024-04-09 name: Tan Tock Seng Hospital class: OTHER briefSummary: The aim of the study is to investigate if hands-on training for basic CCE with virtual reality simulators or guided by artificial intelligence is non-inferior to training by an experienced instructor. conditions: Ultrasound studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 3-arm prospective randomised controlled trial. primaryPurpose: OTHER masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 66 type: ESTIMATED name: AI enabled ultrasound system for self-directed learning name: Simulator for self-directed learning name: traditional with human instructors measure: Improvement in image acquisition and structure identification at the end of 3 months. sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tan Tock Seng Hospital status: RECRUITING city: Singapore zip: 319581 country: Singapore name: Yie H Lau role: CONTACT phone: 6563577771 email: yie_hui_lau@ttsh.com.sg name: Yie H Lau role: PRINCIPAL_INVESTIGATOR lat: 1.28967 lon: 103.85007 hasResults: False

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