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Secondary outcomes will include:
* Statistic metric of association between P0.1, ΔP, PMI and ΔPes
* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and PaO2/FiO2 ratio
* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and tidal volume
* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and DTF%
* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and Ex/DTF%
* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and respiratory rate, VAS dyspnea and VAS discomfort.
Participants will undergo the following tasks and treatments:
* Complete written informed consent before enrollment.
* Post-extubation noninvasive ventilation via nose-to-mouth and full-face masks.
* Monitoring of esophageal pressure (in all patients the catheter will be placed before extubation, according to clinical judgment, and its correct position will be verified through a positive pressure occlusion test)
* Continuous recording of airway pressure, flow, and esophageal pressure (Pes), using a dedicated pneumotachograph and pressure transducer.
* Sudden end-inspiratory and end-expiratory occlusion maneuvers, to measure plateau pressure (Pplat) and end-expiratory airway occlusion pressure (ΔPocc), respectively.
* Collection of hemodynamic and arterial blood-gas parameters, performed according to clinical judgment, along with assessments of dyspnea and discomfort using a modified visual analogue scale (VAS).
* Diaphragm ultrasound during occlusion maneuvers, measuring diaphragm displacement, diaphragm thickening fraction (DTF%), and diaphragmatic excursion (Ex) under various conditions. conditions: Respiratory Disease conditions: Artificial Respiration studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: End-inspiratory Maneuvers measure: Statistic metric of association between ΔPocc and ΔPes measure: Statistic metric of association between P0.1, ΔP, PMI and ΔPes measure: Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and PaO2/FiO2 ratio measure: Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and tidal volume measure: Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and DTF% measure: Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and Ex/DTF% measure: Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and respiratory rate, VAS dyspnea and VAS discomfort measure: Reliability of various noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda ospedaliero-universitaria consorziale policlinico di Bari status: RECRUITING city: Bari zip: 70124 country: Italy name: Salvatore Grasso, MD, Professor role: CONTACT email: [email protected] name: Francesco Murgolo, MD role: PRINCIPAL_INVESTIGATOR name: Domenico Luca Grieco, MD role: PRINCIPAL_INVESTIGATOR lat: 41.11148 lon: 16.8554 hasResults: False
<|newrecord|> nctId: NCT06344221 id: 2023-A00954-41 briefTitle: Post-stroke Haptic Feedback Use Deficit: A Comparative and Reliability Study acronym: HapticS overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-07-15 date: 2024-07-15 date: 2024-04-03 date: 2024-04-03 name: Centre Hospitalier St Anne class: OTHER name: Brain & Spine Institute (ICM) name: Centre Hospitalier Régional d'Orléans briefSummary: The aim of this comparative and reliability study is to highlight a deficit in the use of vibrotactile sensory feedback (haptic effect) in the planning and execution of fine manual dexterity movements after stroke. The investigators will include 3 groups of subjects, 1 group of young healthy subjects, 1 of older subjects matched in age and sex to the group of chronic stroke patients. Participants will take part in clinical tests of fine motor skills and sensitivity and will use a device to assess the key components of manual dexterity, to which vibrotactile sensors will be added. If they so wish, participants will be able to take part in a transcranial magnetic stimulation (TMS) study to assess the facilitation of cortical excitability due to the haptic effect. conditions: Stroke conditions: Upper Extremity Paresis conditions: Manual Dexterity conditions: Sensory Integration Dysfunction conditions: Vibration; Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 90 type: ESTIMATED name: Dextrain Manipulandum and haptic feedback device measure: Assessing haptic effect during a dexterity exercise with and without sensory feedback: finger independence measure: Assessing haptic effect during another dexterity exercise with and without sensory feedback: the force control of the index measure: Assessing haptic effect during another dexterity exercise with and without sensory feedback: the rhythm capacity measure: Correlation between clinical assessment and haptic measure measure: Assessment of the feasibility of the haptic measures measure: Assessment of the benefits of the haptic measures measure: Study the test re-test reliability of the haptic device by comparing the haptic effect on dexterity assessed at the beginning and end of the session by the same evaluator measure: Assessment of the impact of age on the dexterity performances (Finger independence, force control of the index and rhythm capacity) measure: Measurement of the manual dexterity facilitation between tactile (haptic device with vibrations on the fingers) and auditory feedback (sounds during the dexterity tasks) measure: Transcranial magnetic stimulation (TMS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06344208 id: IEO 1647 briefTitle: Predicting Toxicity in Elderly Patients With Head and Neck Cancer acronym: PREtoxEL overallStatus: RECRUITING date: 2022-03-15 date: 2024-12-31 date: 2024-12-31 date: 2024-04-03 date: 2024-04-03 name: European Institute of Oncology class: OTHER briefSummary: Predicting toxicity in elderly patients with head and neck cancer:
validating a disease-oriented toxicity predictive tool and integrating it with avail-able screening tools for better outcomes. conditions: Head and Neck Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3 type: ESTIMATED measure: Predicting toxicity in elderly patients with head and neck cancer sex: ALL minimumAge: 70 Years maximumAge: 99 Years stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan state: MI zip: 20141 country: Italy name: maria Cossu Rocca, MD role: CONTACT phone: 00390294372900 email: [email protected] lat: 45.46427 lon: 9.18951 hasResults: False
<|newrecord|> nctId: NCT06344195 id: 2517 briefTitle: Valacyclovir Monotherapy in Pain Management of Acute Periapical Abscesses After Emergency Chamber Opening acronym: Antiviral overallStatus: RECRUITING date: 2024-03-27 date: 2024-04 date: 2024-05 date: 2024-04-03 date: 2024-04-10 name: Dow University of Health Sciences class: OTHER briefSummary: This study is aimed to evaluate the efficacy of valacyclovir in reducing postoperative pain following emergency chamber opening for acute apical abscess .
There will be 82 participants, (41 in each group) Group A will receive Valacyclovir Group B will receive standard treatment i.e. Naproxen Sodium. Pain level will be assessed by using Numeric rating scale for 6 days conditions: Acute Apical Abscess studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 82 type: ESTIMATED name: Valacyclovir 500 mg name: Naproxen Sodium 550mg measure: Changes in pain score using Numeric Rating Scale (NRS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr. Yumna Shaheen Ali status: RECRUITING city: Karachi state: Sindh zip: 75290 country: Pakistan name: Dr. Yumna Shaheen Ali role: CONTACT email: [email protected] lat: 24.8608 lon: 67.0104 hasResults: False
<|newrecord|> nctId: NCT06344182 id: STarkan briefTitle: Reliability, Concurrent Validity and Minimal Detectable Change of the Step Up and Down Test in Patients With Total Knee Arthroplasty overallStatus: COMPLETED date: 2021-02-01 date: 2021-05-15 date: 2021-05-15 date: 2024-04-03 date: 2024-04-03 name: Dokuz Eylul University class: OTHER briefSummary: The aim of the study is to measure the validity and reliability of the StUD test in patients with TKA. Forty-seven patients with primary TKA included in this study. The test-retest reliability of the StUD test was measured with 1-hour interval. Validity was assessed that the 30s Chair Stand Test (30sCS), the Hospital for Special Surgery score (HSS) and Short Form-12 Quality Life Questionnaire (SF-12) were used as comparator instruments. conditions: Total Knee Arthroplasty studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 47 type: ACTUAL name: Step Up and Down Test measure: Step Up and Down Test measure: 30 Seconds Chair Stand Test measure: Hospital for Special Surgery (HSS) Knee Score measure: 12-Item Short-Form Health Survey sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dokuz Eylul University city: Izmir country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False
<|newrecord|> nctId: NCT06344169 id: DTCRD112(2)-I-15 briefTitle: Dinalbuphine Ester (Naldebain) for Pain Management After Cesarean Section overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-03-14 date: 2026-06-14 date: 2024-04-03 date: 2024-04-22 name: Dalin Tzu Chi General Hospital class: OTHER briefSummary: Inadequate postoperative pain management can lead to physical and psychological distress in patients as well as impact surgical wound healing and increase the risk of developing postoperative delirium and cardiopulmonary and thromboembolic events. Severe postoperative pain may also result in the development of chronic post-surgical pain (CPSP), which in turn can lead to prolonged use of opioids and increased health-care costs. A descriptive survey study in 60 postpartum women who received cesarean section suggested that the presence of postoperative pain significantly reduced the willingness of breastfeeding and infant care. The incidence of CPSP after cesarean delivery has been reported to vary from 1% to 18% up to 1 year after operation. Intrathecal morphine (ITM) injection is considered as the standard pain management strategy for post-cesarean pain. However, the overall analgesic effect of ITM is about 8-12h and it is associated with pruritus, nausea/vomiting, urinary retention, constipation, mental status change, and respiratory depression. Therefore, the development of a safe, conveniently operated, and long-lasting analgesic strategy, which serves as background pain control modality up to several days after cesarean section should provide clinically beneficial advantages in the management of acute postoperative pain and prevention of CPSP in postpartum women. Naldebain® is prodrug of nalbuphine, which was approved by the Taiwan FDA in 2017. Naldebain® is rapidly hydrolyzed by tissue of plasma esterase to release nalbuphine. The bioavailability of nalbuphine following intramuscular injection Naldebain® was 85.4%, and it took approximately 6 days for the complete release of Naldebain® into the blood circulation. Therefore, a single parenteral injection of Naldebain® could provide long lasting analgesic effect in several phase II trials. However, Naldebain® has not been tested in the pain control after cesarean section. Therefore, this PI-initiated prospective, randomized, open-label, non-inferiority trial aims to investigate the clinical efficacy of Naldebain® in management of acute postoperative pain in term parturient who receive elective cesarean section to provide analgesic effect that is not inferior to the standard ITM and prevent the development of CPSP. conditions: Postsurgical Pain conditions: Cesarean Section conditions: Chronic Post-surgical Pain studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, open-label, non-inferiority trial primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Sebacoyl Dinalbuphine Ester name: Morphine measure: Intensity of surgical pain after operation as assessed by visual analogue scale measure: Rescue doses of analgesics administered after operation measure: Incidence of chronic post-surgical pain measure: Satisfaction of living after surgery as assessed by the HRQoL short-form (SF)-12 sex: FEMALE minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06344156 id: PDAC-Neoantigen briefTitle: Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy as an Adjuvant Therapy for Pancreatic Cancer overallStatus: RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2027-04-01 date: 2024-04-03 date: 2024-04-03 name: Sichuan University class: OTHER briefSummary: The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in postoperative adjuvant treatment of Pancreatic Cancer conditions: Pancreatic Cancer conditions: Adjuvant Therapy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 43 type: ESTIMATED name: Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy measure: 18-month RFS measure: Incidence of Treatment-Related Adverse Events [Safety and Tolerability] measure: 18-month OS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital, Sichuan University status: RECRUITING city: Chengdu state: Sichuan zip: 610000 country: China name: Zhong Wu, MD role: CONTACT phone: 028-85422851 email: [email protected] name: Zhong Wu role: PRINCIPAL_INVESTIGATOR lat: 30.66667 lon: 104.06667 hasResults: False
<|newrecord|> nctId: NCT06344143 id: 24-324 briefTitle: Detecting Mild Autonomous Cortisol Secretion in Patients With Adrenal Incidentaloma acronym: MACS overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2029-11-01 date: 2030-12-31 date: 2024-04-03 date: 2024-04-26 name: The Cleveland Clinic class: OTHER name: Recordati Rare Diseases briefSummary: The aim of the proposed study is to estimate the incidence of Mild Autonomous Cortisol Secretion (MACS) in patients with Adrenal Incidentaloma (AI) and evaluate the available diagnostic tests to determine the most sensitive and specific combination of tests for assessing MACS from adrenal adenoma for prediction of the phenotype associated with cortisol excess. As well as following the patients for 4 years and see if anything changes. conditions: Mild Autonomous Cortisol Secretion (MACS) studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Various labs and imaging tests measure: Evaluate best diagnostic test(s) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Cleveland Clinic Foundation city: Cleveland state: Ohio zip: 44195 country: United States name: Maya Boyd role: CONTACT phone: 216-444-4919 email: [email protected] name: [email protected] Jenkins role: CONTACT phone: 216-445-4791 email: [email protected] lat: 41.4995 lon: -81.69541 hasResults: False
<|newrecord|> nctId: NCT06344130 id: 10001859 id: 001859-C briefTitle: Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-12-31 date: 2027-12-31 date: 2024-04-03 date: 2024-04-26 name: National Cancer Institute (NCI) class: NIH briefSummary: Background:
Glioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within months or years after treatment, and when they do, they are worse: Overall survival drops to less than 10 months. No standard treatment exists for people whose GBM has returned after radiation therapy.
Objective:
To find a safe schedule for using radiation to treat GBM tumors that returned after initial radiation treatment.
Eligibility:
People aged 18 years and older with grade 4 GBM that returned after initial radiation treatment.
Design:
Participants will be screened. They will have a physical exam with blood tests. A sample of tumor tissue may be collected.
Participants will undergo re-irradiation planning: They will wear a plastic mask over their head during imaging scans. These scans will pinpoint the exact location of the tumor. This spot will be the target of the radiation treatments.
Participants will undergo radiation treatment 4 times per week. Some people will have this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other exams will be repeated at each visit.
Participants will complete questionnaires about their physical and mental health. They will answer these questions before starting radiation treatment; once a week during treatment; and at intervals for up to 3 years after treatment ends.
Participants will have follow-up visits 1 month after treatment and then every 2 months for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or email will continue an additional 2 years. conditions: Astrocytoma conditions: Glioma conditions: Recurrent Glioblastoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: Radiation Therapy measure: MTD of daily re-irradiation in participants with recurrent grade 4 gliomas measure: Progression free survival measure: Overall survival measure: Compliance and feasibility of administering PRO in this participant population measure: Tolerability of treatment by assessing adverse events, cognitive function, physical function, and side effect bother measure: Longitudinally describe and evaluate disease and treatment-related symptom severity and interference with daily activities measure: Meaningful change in disease and treatment-related symptoms by using anchors sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institutes of Health Clinical Center city: Bethesda state: Maryland zip: 20892 country: United States name: National Cancer Institute Referral Office role: CONTACT phone: 888-624-1937 lat: 38.98067 lon: -77.10026 hasResults: False
<|newrecord|> nctId: NCT06344117 id: MF3 UHN (IA) briefTitle: Assessment of Volatile Organic Compounds (VOC) for the Diagnosis of Invasive Aspergillosis (IA) in Lung Transplant Recipients acronym: UHN overallStatus: RECRUITING date: 2023-12-12 date: 2025-07 date: 2025-12 date: 2024-04-03 date: 2024-04-03 name: Owlstone Ltd class: INDUSTRY briefSummary: Prospective observational pilot study to evaluate the utility of breath VOCs to detect invasive aspergillosis in lung transplant recipients that are suspected of invasive fungal disease (IFD). conditions: Invasive Aspergillosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 45 type: ESTIMATED measure: Identifying a statistical relationship between Volatile Organic Compounds detection and the diagnosis of IA by existing International Society for Heart and Lung Transplantation (ISHLT) and MSG/EORTC criteria. measure: Identifying a statistical relationship between the set of VOCs found in exhaled breath and the diagnosis of Aspergillus colonization as defined by ISHLT criteria sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network status: RECRUITING city: Toronto state: Ontario zip: M5G 2N2 country: Canada name: Shahid Husain, MD,MS role: CONTACT phone: (416) 340-3144 email: [email protected] name: Shahid Husain, MD,MS role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
<|newrecord|> nctId: NCT06344104 id: D6970C00008 briefTitle: A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Asian Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension acronym: BaxAsia overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2026-05-20 date: 2026-05-20 date: 2024-04-03 date: 2024-04-03 name: AstraZeneca class: INDUSTRY briefSummary: The purpose of this study is to measure the efficacy and safety of baxdrostat in Asian participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets. conditions: Uncontrolled Hypertension conditions: Resistant Hypertension studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: placebo control primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Baxdrostat name: Placebo measure: Change from baseline in siSBP at Week 12 measure: Change from baseline in siSBP at Week 12 measure: Change from RWD baseline (Week 24) in siSBP at Week 32 measure: Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM measure: Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM measure: Change from baseline in siDBP at Week 12 measure: Achieving siSBP < 140 mmHg at Week 12 measure: Change from baseline in siDBP at Week 12 measure: Achieving siSBP < 140 mmHg at Week 12 measure: Change from baseline in siSBP at Week 12 measure: Change from baseline in siSBP at Week 12 measure: Number of participants with adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site city: Caba zip: C1426 country: Argentina lat: -34.61315 lon: -58.37723 facility: Research Site city: Baotou zip: 014010 country: China lat: 40.65222 lon: 109.82222 facility: Research Site city: Beijing zip: 100029 country: China lat: 39.9075 lon: 116.39723 facility: Research Site city: Beijing zip: 100044 country: China lat: 39.9075 lon: 116.39723 facility: Research Site city: Bengbu zip: 233060 country: China lat: 32.94083 lon: 117.36083 facility: Research Site city: Changde zip: 415003 country: China lat: 29.04638 lon: 111.6783 facility: Research Site city: Changsha zip: 410015 country: China lat: 28.19874 lon: 112.97087 facility: Research Site city: Changsha zip: 430033 country: China lat: 28.19874 lon: 112.97087 facility: Research Site city: Changzhou zip: 272100 country: China lat: 31.77359 lon: 119.95401 facility: Research Site city: Chengdu zip: 610041 country: China lat: 30.66667 lon: 104.06667 facility: Research Site city: Chongqing zip: 400010 country: China lat: 29.56278 lon: 106.55278 facility: Research Site city: Chongqing zip: 400042 country: China lat: 29.56278 lon: 106.55278 facility: Research Site city: Deyang zip: 618000 country: China lat: 31.13019 lon: 104.38198 facility: Research Site city: Guangzhou zip: 510100 country: China lat: 23.11667 lon: 113.25 facility: Research Site city: Ha'er Bin zip: 150001 country: China facility: Research Site city: Hangzhou zip: 310014 country: China lat: 30.29365 lon: 120.16142 facility: Research Site city: Hefei zip: 230601 country: China lat: 31.86389 lon: 117.28083 facility: Research Site city: Heze zip: 274099 country: China lat: 35.23929 lon: 115.47358 facility: Research Site city: Jiujiang zip: 332000 country: China lat: 29.70475 lon: 116.00206 facility: Research Site city: Luoyang zip: 471000 country: China lat: 34.68361 lon: 112.45361 facility: Research Site city: Meihekou zip: 135022 country: China lat: 42.52722 lon: 125.67528 facility: Research Site city: Nanchang zip: 330009 country: China lat: 28.68396 lon: 115.85306 facility: Research Site city: Nanchong zip: 637900 country: China lat: 30.79508 lon: 106.08473 facility: Research Site city: Nanjing zip: 210009 country: China lat: 32.06167 lon: 118.77778 facility: Research Site city: Ningbo zip: 315020 country: China lat: 29.87819 lon: 121.54945 facility: Research Site city: Panjin zip: 124009 country: China lat: 41.121 lon: 122.0739 facility: Research Site city: Puyang zip: 457000 country: China lat: 29.45679 lon: 119.88872 facility: Research Site city: Qiqihar zip: 161000 country: China lat: 47.34088 lon: 123.96045 facility: Research Site city: Sanya zip: 572000 country: China lat: 18.24306 lon: 109.505 facility: Research Site city: Shanghai zip: 200025 country: China lat: 31.22222 lon: 121.45806 facility: Research Site city: Shanghai zip: 200040 country: China lat: 31.22222 lon: 121.45806 facility: Research Site city: Shenyang zip: 110004 country: China lat: 41.79222 lon: 123.43278 facility: Research Site city: Shenyang zip: 110016 country: China lat: 41.79222 lon: 123.43278 facility: Research Site city: Taiyuan zip: 030024 country: China lat: 37.86944 lon: 112.56028 facility: Research Site city: Tianjin zip: 300457 country: China lat: 39.14222 lon: 117.17667 facility: Research Site city: Tianjin country: China lat: 39.14222 lon: 117.17667 facility: Research Site city: Wuhan zip: 430010 country: China lat: 30.58333 lon: 114.26667 facility: Research Site city: Wuhan zip: 430022 country: China lat: 30.58333 lon: 114.26667 facility: Research Site city: Wuhan zip: 430060 country: China lat: 30.58333 lon: 114.26667 facility: Research Site city: Xianyang zip: 712000 country: China lat: 34.33778 lon: 108.70261 facility: Research Site city: Xianyang zip: 750004 country: China lat: 34.33778 lon: 108.70261 facility: Research Site city: Xuzhou zip: 221000 country: China lat: 34.18045 lon: 117.15707 facility: Research Site city: Yangzhou zip: 225001 country: China lat: 32.39722 lon: 119.43583 facility: Research Site city: Yinchuan zip: 750001 country: China lat: 38.46806 lon: 106.27306 facility: Research Site city: Zhengzhou country: China lat: 34.75778 lon: 113.64861 facility: Research Site city: Zigong zip: 643021 country: China lat: 29.34162 lon: 104.77689 facility: Research Site city: Hong Kong zip: 00000 country: Hong Kong lat: 22.27832 lon: 114.17469 facility: Research Site city: Hong Kong zip: 0000 country: Hong Kong lat: 22.27832 lon: 114.17469 facility: Research Site city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 facility: Research Site city: Bangalore zip: 560 092 country: India lat: 12.97194 lon: 77.59369 facility: Research Site city: Belgaum zip: 590016 country: India lat: 15.85212 lon: 74.50447 facility: Research Site city: Kanpur zip: 208002 country: India lat: 26.46523 lon: 80.34975 facility: Research Site city: New Delhi zip: 110002 country: India lat: 28.63576 lon: 77.22445 facility: Research Site city: New Delhi zip: 110060 country: India lat: 28.63576 lon: 77.22445 facility: Research Site city: Surat zip: 395001 country: India lat: 21.19594 lon: 72.83023 facility: Research Site city: Chuo-ku zip: 103-0027 country: Japan lat: 35.57779 lon: 139.71685 facility: Research Site city: Chuo-ku zip: 260-0804 country: Japan lat: 35.57779 lon: 139.71685 facility: Research Site city: Kagoshima-shi zip: 890-8520 country: Japan lat: 31.56667 lon: 130.55 facility: Research Site city: Minato-ku zip: 108-0073 country: Japan lat: 34.2152 lon: 135.1501 facility: Research Site city: Tsukuba-shi zip: 305-0861 country: Japan lat: 36.2 lon: 140.1 facility: Research Site city: Utsunomiya-shi zip: 320-8580 country: Japan lat: 36.56667 lon: 139.88333 facility: Research Site city: Yokohama-shi zip: 234-0054 country: Japan lat: 35.43333 lon: 139.65 facility: Research Site city: Yokohama-shi zip: 236-0004 country: Japan lat: 35.43333 lon: 139.65 facility: Research Site city: Daejeon zip: 35015 country: Korea, Republic of lat: 36.32139 lon: 127.41972 facility: Research Site city: Seoul zip: 02841 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Seoul zip: 03722 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Seoul zip: 04763 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Seoul zip: 05505 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Seoul zip: 13620 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Iloilo City zip: 5000 country: Philippines lat: 10.69694 lon: 122.56444 facility: Research Site city: Quezon City zip: 1112 country: Philippines lat: 14.6488 lon: 121.0509 facility: Research Site city: St Petersburg zip: 197341 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Research Site city: Ankara zip: 06800 country: Turkey lat: 39.91987 lon: 32.85427 facility: Research Site city: Kahramanmaras zip: 46100 country: Turkey lat: 37.5847 lon: 36.92641 facility: Research Site city: Kayseri zip: 38039 country: Turkey lat: 38.73222 lon: 35.48528 facility: Research Site city: Kocaeli zip: 41380 country: Turkey lat: 39.62497 lon: 27.51145 facility: Research Site city: Hanoi zip: 100000 country: Vietnam lat: 21.0245 lon: 105.84117 facility: Research Site city: Ho Chi Minh zip: 700000 country: Vietnam lat: 10.82302 lon: 106.62965 facility: Research Site city: Hochiminh city zip: 700000 country: Vietnam lat: 10.82302 lon: 106.62965 facility: Research Site city: Hochiminh zip: 70000 country: Vietnam hasResults: False
<|newrecord|> nctId: NCT06344091 id: ZYWB-ZM-AHP-A-003 briefTitle: A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-06 date: 2026-09-28 date: 2026-10-12 date: 2024-04-03 date: 2024-04-03 name: Jiangsu HengRui Medicine Co., Ltd. class: INDUSTRY briefSummary: The study is being conducted to evaluate the safety and efficacy of bupivacaine liposome injection for local infiltration analgesia in pediatric orthopedic surgery in the real world. conditions: Local Analgesia Via Infiltration studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A single-arm study of liposomal bupivacaine injection primaryPurpose: PREVENTION masking: NONE count: 232 type: ESTIMATED name: Bupivacaine Liposome Injection measure: The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system measure: The cumulative amount of opioids used in 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration measure: Time to first rescue analgesia of opioid measure: The proportion of patients who did not use rescue analgesia during 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration measure: The proportion of patients using patient-controlled intravenous analgesia (PCIA) measure: Pain intensity score at rest after administration for children aged 6 to 7 years measure: Pain intensity score at rest after administration for children aged 8 years and older measure: Pain intensity score on movement (or cough) after administration for children aged 6 to 7 years measure: Pain intensity score on movement (or cough) after administration for children aged 8 years and older measure: Length of Stay sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: Guangzhou Women and Children's Medical Center city: Guangzhou state: Guangdong zip: 510000 country: China name: Xingrong Song role: CONTACT lat: 23.11667 lon: 113.25 hasResults: False
<|newrecord|> nctId: NCT06344078 id: SIGMA-d briefTitle: Surgical Italian Guide for the Management of Complicated Acute Diverticulitis Emergency Setting (SIGMA-D). A Prospective Observational Multicenter Study on Behalf of the Italian Society of Colorectal Surgery (SICCR). acronym: SIGMA-D overallStatus: RECRUITING date: 2024-01-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-03 date: 2024-04-03 name: Societa Italiana di Chirurgia ColoRettale class: NETWORK briefSummary: This study will include data collected from surgical units performing emergency surgery in Italy during 2024, with a one-year follow-up period for each patient. Data for each center will be prospectively collected through a database filled out by the Italian Society of Colorectal Surgery (SICCR) members who participate to the study. Specific data will include: WSES diverticulitis classification, procedure timing, laparoscopic/converted procedures, rate of performed protection ileostomies or colostomies, rate and timing of Hartmann reversal or stoma closure, procedures with more than two operators, procedures with expert first operator, night or weekend procedures, and patients aged over 80. Postoperative data will focus on complication rates and mortality at one, six, and twelve months. conditions: Acute Diverticulitis conditions: Stoma Colostomy conditions: Stoma Ileostomy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: sigmoid resection and anastomosis / stoma measure: adhesion to guidelines measure: stoma reversal sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda ospedaliera universitaria paolo giaccone status: RECRUITING city: Palermo country: Italy name: francesco ferrara, medicine and surgery role: CONTACT phone: +393343035829 email: [email protected] name: claudio guerci role: CONTACT phone: +393473898094 email: [email protected] lat: 38.13205 lon: 13.33561 hasResults: False
<|newrecord|> nctId: NCT06344065 id: 20220102C briefTitle: Immunogenicity and Safety of Diphtheria, Tetanus, Pertussis (DTaP) Vaccine in 3-month-old Infants overallStatus: RECRUITING date: 2023-12-21 date: 2025-05-25 date: 2028-12-25 date: 2024-04-03 date: 2024-04-03 name: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd class: INDUSTRY briefSummary: The purpose of this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1584 type: ESTIMATED name: Diphtheria, tetanus and acellular pertussis (component) combined vaccine (adsorbed) name: Diphtheria, tetanus and acellular pertussis combined vaccine (adsorbed) name: Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine measure: Immunogenicity results of experimental group and active control group (DTaP) measure: Immunogenicity results of experimental group and active control group (DTaP-IPV//PRP-T) measure: Immunogenicity results of experimental group sex: ALL minimumAge: 3 Months maximumAge: 3 Months stdAges: CHILD facility: Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention status: RECRUITING city: Nanning state: Guangxi zip: 530028 country: China name: Yi Mo role: CONTACT phone: +86-13788686968 email: [email protected] lat: 22.81667 lon: 108.31667 hasResults: False
<|newrecord|> nctId: NCT06344052 id: SP-002-004 briefTitle: To Assess the Safety and Efficacy of SP-002 With Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma overallStatus: RECRUITING date: 2024-04-09 date: 2026-09-30 date: 2029-03-30 date: 2024-04-03 date: 2024-04-10 name: Stamford Pharmaceuticals, Inc. class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the efficacy of using SP-002 in participants with locally advanced Basal cell carcinoma. The main question it aims to answer is what the objective response rate for a basal cell carcinoma tumor is following 1 or 3 cycles of SP-002 treatment given as an add-on to hedgehog pathway inhibitor therapy.
Researchers will compare the objective response rate for treated Basal cell carcinoma tumors between 3 treatment Arms.
* Arm 1 participants will receive daily hedgehog pathway inhibitor, and 3 cycles of SP-002 treatment.
* Arm 2 participants will receive daily hedgehog pathway inhibitor, and 1 cycle of SP-002 treatment.
* Arm 3 participants will receive daily hedgehog pathway inhibitor only. conditions: Basal Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: SP-002 name: Vismodegib measure: Objective response rate measure: Duration of response measure: Progressive free survival measure: Overall survival (OS) measure: Objective Response Rate (ORR) / Complete Response (CR) / Partial Response (PR) measure: Number of subjects discontinuing treatment with SP-002 and/or vismodegib due to toxicity. measure: Number of subjects with delays to SP-002 and/or vismodegib dosing due to toxicity. measure: Incidence and severity of SP-002 and/or vismodegib related AEs. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85006 country: United States lat: 33.44838 lon: -112.07404 facility: Research Site status: NOT_YET_RECRUITING city: Lee's Summit state: Missouri zip: 64064 country: United States lat: 38.91084 lon: -94.38217 facility: Research Site status: RECRUITING city: Cedar Park state: Texas zip: 78613 country: United States lat: 30.5052 lon: -97.82029 facility: Research Site status: NOT_YET_RECRUITING city: Humble state: Texas zip: 77346 country: United States lat: 29.99883 lon: -95.26216 facility: Research Site status: NOT_YET_RECRUITING city: Longview state: Texas zip: 75601 country: United States lat: 32.5007 lon: -94.74049 hasResults: False
<|newrecord|> nctId: NCT06344039 id: Floating hip briefTitle: Epidemiological Study of Floating Hip Injuries in Assiut University Hospitals overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-05 date: 2024-04-03 date: 2024-04-05 name: Assiut University class: OTHER briefSummary: Aim of the study is to describe and study the patterns of floating hip injuries and assess the current management in Assiut University Hospitals Trauma Centre to help reach the best approach to plan treatment for these severe and difficult injuries. conditions: Hip Fractures conditions: Hip Injuries studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED measure: Incidence of floating hip injuries measure: Patterns of injury sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06344026 id: ANPD001-02 briefTitle: Phase 1/2a Study of ANPD001 in Parkinson Disease acronym: ASPIRO overallStatus: ENROLLING_BY_INVITATION date: 2024-01-23 date: 2025-10-30 date: 2030-04-30 date: 2024-04-03 date: 2024-04-19 name: Aspen Neuroscience class: INDUSTRY name: California Institute for Regenerative Medicine (CIRM) briefSummary: This clinical trial is designed to test the safety and tolerability of injecting ANPD001 cells that will mature into dopamine-producing cells into the brain of participants with Parkinson Disease. All participants will have ANPD001 cells manufactured from their own previously collected cells. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open label, dose escalation of bilateral injection of ANPD001 dopaminergic precursor cells to the putamen primaryPurpose: TREATMENT masking: NONE count: 9 type: ESTIMATED name: ANPD001 name: Custom Device measure: Incidence and severity of treatment emergent adverse events (Safety and Tolerability) measure: "ON" time without troublesome dyskinesia measure: Post-injection change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II (Activities of Daily Living - ADL) and Part III (motor score) in the ON state (total score and scores for Parts I-IV) measure: Post-injection change in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score in the practically defined OFF state measure: Post-injection change in the 18F-DOPA uptake in the putamen measure: Incidence and severity of treatment emergent adverse events during long term follow-up (Continued Safety and Tolerability) sex: ALL minimumAge: 50 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Arizona - Banner Health city: Tucson state: Arizona zip: 85724 country: United States lat: 32.22174 lon: -110.92648 facility: Scripps Health city: La Jolla state: California zip: 92037 country: United States lat: 32.84727 lon: -117.2742 facility: University of California, Irvine city: Orange state: California zip: 92868 country: United States lat: 33.78779 lon: -117.85311 facility: University of California, San Francisco city: San Francisco state: California zip: 94143 country: United States lat: 37.77493 lon: -122.41942 facility: Feinstein Institutes city: Manhasset state: New York zip: 11030 country: United States lat: 40.79788 lon: -73.69957 hasResults: False
<|newrecord|> nctId: NCT06344013 id: 29BRC24.0034 - BUNDLE ABCDEF briefTitle: The ABCDEF Bundle in Critical Care: a French National Survey Still a Long Way to go! overallStatus: COMPLETED date: 2022-07-01 date: 2022-07-31 date: 2022-07-31 date: 2024-04-03 date: 2024-04-03 name: University Hospital, Brest class: OTHER briefSummary: The goal of this observational study is to evaluate the knowledge and compliance of French intensive care units with the ABCDEF (A: Assessment, Prevention, Management of Pain, B: Both Spontaneous Awakening Trials and Spontaneous Breathing Trials, C: Choice of Sedation and Analgesia, D: Delirium Assessment, Prevention, and Management, E: Early Mobility and Exercise, F: Family Engagement and Empowerment) bundle. French ICU doctors will be asked to answer a questionnaire available online. conditions: Delirium studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 341 type: ACTUAL measure: knowledge and compliance of French intensive care units with the ABCDEF sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Brest city: Brest zip: 29609 country: France lat: 48.3903 lon: -4.48628 hasResults: False
<|newrecord|> nctId: NCT06344000 id: RICU20240323 briefTitle: Study on Disease Progression and Nutritional Status in Bronchiectasis overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-04-15 date: 2027-04-15 date: 2024-04-03 date: 2024-04-03 name: Wuhan Union Hospital, China class: OTHER briefSummary: Bronchiectasis is a common lung disease. The Bronchiectasis Severity Index (BSI) is a widely used assessment system. The body mass index (BMI) is a commonly used measure of nutritional status, but it has its limitations. To provide a more comprehensive assessment, the investigators also consider other nutrition-related indices such as upper arm circumference, calf circumference, skinfold thickness and grip strength. The investigators will specify the relationship between nutritional status and disease progression by measuring nutrition-related indicators and tracking participants' disease progression. conditions: Bronchiectasis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: inapplicable measure: Frequency of acute exacerbations of bronchiectasis measure: Deterioration of lung function measure: Severity of dyspnoea measure: Bhalla scores on CT of participants' lungs measure: Frequency of hospitalisation measure: Death sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wuhan Union Hospital city: Wuhan state: Hubei zip: 430022 country: China name: Xiaorong Wang role: CONTACT phone: 18627195231 phoneExt: +86 email: [email protected] lat: 30.58333 lon: 114.26667 hasResults: False
<|newrecord|> nctId: NCT06343987 id: 1-10-72-165-23 briefTitle: The FEMA Study: Feasibility of Exercise in Patients With Metastatic Breast Cancer and Adiposity overallStatus: RECRUITING date: 2024-02-19 date: 2024-12 date: 2025-03 date: 2024-04-03 date: 2024-04-09 name: Aarhus University Hospital class: OTHER name: Danish Cancer Society briefSummary: The goal of this clinical trial is to test a physical activity program in patients with metastatic breast cancer and overweight receiving endocrine-based treatment.
The aim of the study is to assess the feasibility and metabolic efficacy of a 12-week physical activity program in this patient group. The hypothesis is that improving metabolic health through physical activity can optimize cancer care.
Participants will randomized 2:1 to either a physical activity program or care as usual. conditions: Metastatic Breast Cancer conditions: Estrogen-receptor-positive Breast Cancer conditions: Adiposity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Continuous inclusion. Randomized 2:1 - intervention group and observational group, respectively. primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: Physical Activity measure: Adherence as assessed by attendance rate measure: Metabolic efficacy assessed by change in metabolic score measure: Perceived satisfaction assessed by qualitative interviews measure: Health-related quality of life as assessed by EORTC-QLQ-30 measure: Cancer coping as assessed by CBI-12 measure: Sleep quality as assessed by PSQI measure: Insomnia as assessed by ISI measure: Change in C-reactive protein measure: Change in leukocytes measure: Change in HbA1c measure: Change in LDL cholesterol measure: Change in HDL cholesterol measure: Change in BMI measure: Fat mass measure: Muscle mass measure: Visceral fat measure: VO2 max measure: Handgrip strength measure: Sit-rising sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Oncology, Aarhus University Hospital status: RECRUITING city: Aarhus N state: Central Denmark Region zip: 8200 country: Denmark name: Signe Borgquist, MD, PhD role: CONTACT phone: + 45 22 62 45 25 email: [email protected] name: May W Nielsen, Bsc.Med. role: CONTACT phone: +45 29 90 66 05 email: [email protected] lat: 56.15674 lon: 10.21076 hasResults: False
<|newrecord|> nctId: NCT06343974 id: 0843 briefTitle: Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-31 date: 2026-05-01 date: 2024-04-03 date: 2024-04-03 name: Turku University Hospital class: OTHER_GOV briefSummary: The goal of this observational study is to compare fetal liver ultrasound radiomics between pregnancies complicated by type 1 diabetes and healthy controls.
The main questions it aims to answer are:
* Are fetal liver ultrasound radiomic features reproducible?
* Does fetal liver ultrasound radiomics differ between pregnancies complicated by type 1 diabetes and healthy controls?
Participants will undergo ultrasound examination to collect ultrasound data for the analyses. conditions: Pregnancy in Diabetic conditions: Diabetes Mellitus, Type 1 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: Fetal liver ultrasound texture measure: Birth weight in grams measure: Birth weight centile measure: Large for gestational age (LGA) measure: Interventricular septum (IVS) width measure: Number of pregnancies with neonatal hypoglycemia measure: Rate of neonatal hypoglycemia treated with oral dextrose gel measure: Rate of neonatal hypoglycemia treated with intravenous (IV) glucose measure: Length of treatment for neonatal hypoglycemia measure: Number of neonates admitted to neonatal intensive care unit (NICU) measure: Length of NICU admission measure: Number of pregnancies with neonatal respiratory complications related to maternal diabetes measure: Number of pregnancies with neonatal hyperbilirubinemia measure: Maternal HbA1c concentration measure: Glucose management indicator (GMI) measure: Time in glycemic range (TIR) measure: Time above glucose range measure: Time below glucose range sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Turku University Hospital city: Turku country: Finland lat: 60.45148 lon: 22.26869 hasResults: False
<|newrecord|> nctId: NCT06343961 id: 2024-76 briefTitle: Intraoperative Application of Fluorescein Sodium Angiography in Vascular Retinopathy overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2025-12 date: 2025-12 date: 2024-04-03 date: 2024-04-03 name: Jie Zhong class: OTHER briefSummary: The study used a new surgical technique: intraoperative fluorescence imaging,In the 1980s, some scholars proposed the concept of intraoperative fluorescein angiography.During vitrectomy, intraoperative fluorescein angiography under 3D microscope can guide the surgeon to observe the non-perfusion area and new blood vessels on the same screen for accurate retinal photocoagulation therapy.Through this technology, the primary retinal disease can be identified in time after the removal of vitreous hemorrhage during surgery, providing effective imaging evidence support for the design of further treatment. conditions: Vascular Retinopathy of Left Eye (Disorder) conditions: Vascular Retinopathy of Right Eye (Disorder) conditions: Diabetic Retinopathy conditions: Retinal Vein Occlusion conditions: Retinal Vasculitis conditions: Vitreous Hemorrhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A total of 80 patients with vitreous hemorrhage diagnosed in Sichuan Provincial People's Hospital from January 2024 to December 2025 were selected. The number of included cases was calculated according to the minimum sample size of 200 patients with vitreous hemorrhage in our hospital, 95% confidence level and 5% confidence interval, and the calculated result was 79. The included cases were equally divided by random number method. 40 patients in the control group were given vitrectomy and other conventional operations such as retinal laser photocoagulation. In contrast group, 40 patients were given vitrectomy combined with intraoperative fluorescein angiography and other conventional operations such as retinal laser photocoagulation. The diagnosis rate of primary disease cause, observation rate of neovascularization and non-perfusion area, visual acuity, visual field, thickness of macular fovea and postoperative complications (ciliary detachment, secondary vitreous hemorrhage, neovascu primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Intraoperative Fluorescein Angiography measure: best corrected visual acuity measure: Central retinal thickness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06343948 id: BL-B01D1-306 briefTitle: A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-05 date: 2026-05 date: 2024-04-03 date: 2024-04-04 name: Sichuan Baili Pharmaceutical Co., Ltd. class: INDUSTRY name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. briefSummary: This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced, recurrent, or metastatic HR+HER2- breast cancer after failure of at least one prior line of chemotherapy. conditions: HR+HER2- Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 382 type: ESTIMATED name: BL-B01D1 name: Eribulin name: Vinorelbine name: Gemcitabine name: Capecitabine measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Duration of Response (DOR) measure: Treatment Emergent Adverse Event (TEAE) measure: Anti-drug antibody (ADA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital Chinese Academy of Medical Sciences city: Beijing state: Beijing country: China name: Binghe Xu role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06343935 id: YY-20394-014 briefTitle: A National Multicenter, Real-world Study of Linperlisib in the Treatment of Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-04-30 date: 2025-04-30 date: 2024-04-03 date: 2024-04-03 name: Shanghai YingLi Pharmaceutical Co. Ltd. class: INDUSTRY briefSummary: This is a national multicenter, randomized controlled, open, dose-optimized Phase IV study. It is expected to enroll approximately 88 patients with relapsed/refractory indolent B-cell lymphoma. The aim is to evaluate the efficacy and safety of linperlisib in the treatment of patients with relapsed/refractory indolent B-cell lymphoma at two doses/modes of administration (clinically recommended dose/mode and optimized dose/mode). conditions: Indolent B-cell Lymphoma studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 88 type: ESTIMATED name: Linperlisib measure: Progression free survival measure: Objective response rate measure: Overall survival measure: Adverse event measure: Serious adverse event sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06343922 id: Sadaf Riphah briefTitle: Oral Motor Facilitation Technique And Traditional Exercises on Children With Cerebral Palsy overallStatus: RECRUITING date: 2023-12-01 date: 2024-04 date: 2024-04 date: 2024-04-03 date: 2024-04-03 name: Riphah International University class: OTHER briefSummary: Cerebral palsy is a motor disorder caused by the damage to the developing brain. Feeding and swallowing difficulties are common in children with cerebral palsy (CP). Poor postural control and oral motor dysfunction results in extended feeding time, frequent coughing, choking and excessive drooling affecting their health and quality of life. The brain damage in CP is permanent that cannot be fixed however different oral motor exercises, oral facial facilitation and oral sensorimotor interventions are widely used for drool reduction and feeding difficulties in children with CP. Spastic cerebral palsy is one of most prevalent type of CP that is characterized by increased tone and stiffness of muscles. This research will be conducted to evaluate the comparative effects of oral motor facilitation technique (OMFT) and traditional oral motor exercises on drooling and feeding skills of children with spastic CP. OMFT is a complete protocol with a combination of techniques to deal with oral motor difficulties This study will be a randomized control trial. A total number of 12 children with Spastic cerebral palsy ( GMFS III-V) both male/female, between age range 3-12 and with feeding difficulties will be included in the study. Children with cerebral palsy and other co morbidities, seizures, risk of aspiration and who are on tube feeding will be excluded. Participants will be randomly allocated to two groups, either Group A (receiving OMFT) or Group B (receiving traditional oral motor exercise). Baseline scores will be recorded by using standardized tools OMAS for oral motor skill during feeding and DIS for drool severity with the consent of authors. Therapeutic sessions will be scheduled 3 days per week and 30 min a day for each group. The effects of interventions on drooling and feeding skills will be assessed after 8 and 16 weeks of sessions. Recorded data of all variables will be analyzed by using statistical package for social sciences (SPSS) for Windows Software, version 21. conditions: Cerebral Palsy (CP) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group 1 will receive exercises by using oral motor facilitation technique protocol three times a week Group 2 will receive traditional oral motor exercises three times per week primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 10 type: ESTIMATED name: oral motor facilitation technique group name: traditional oral motor exercises group measure: Change in Drooling measure: Change in feeding skills sex: ALL minimumAge: 3 Years maximumAge: 10 Years stdAges: CHILD facility: Mobilty Quest status: RECRUITING city: Lahore state: Punjab zip: 54000 country: Pakistan name: Mobility Quest role: CONTACT phone: 03336596656 email: [email protected] name: Nazia Mumtaz, PhD role: PRINCIPAL_INVESTIGATOR name: Sadaf Safdar, BS role: SUB_INVESTIGATOR lat: 31.558 lon: 74.35071 hasResults: False
<|newrecord|> nctId: NCT06343909 id: REC/RCR & AHS/23/0197Ayesha briefTitle: Foot and Hip Abductor Strengthening in Patients With Knee Osteoarthritis. overallStatus: RECRUITING date: 2023-11-23 date: 2024-06-01 date: 2024-06-01 date: 2024-04-03 date: 2024-04-03 name: Riphah International University class: OTHER briefSummary: The study will be Randomized controlled trail, Subject diagnosed with knee osteoarthritis meeting predetermined inclusion and exclusion criteria will be divided into two groups.
Pre assessment will be done using pain, ROM, function, foot arches and knee alignment as subjective measurement through KOOS questionnaire, goniometer, 2D frontal plane projection, Berkemann foot prints using ink and paper ,30s chair stand test, nine step stair climb,40m fast paced walk test,Global rating of change score respectively . One group will be treated with hip abductor strengthening exercise along with conventional exercises and second group will be treated with intrinsic foot muscle strengthening exercise along with conventional exercises. Post treatment values recorded after the session.After data collection from defined study setting,data will be entered and analyzed at Riphah International University,Lahore conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Hip abductor strengthening exercise name: Intrinsic foot muscle strengthening along with conventional exercises measure: Knee Osteoarthritis Outcome Score (KOOS) measure: Berkemann foot prints measure: Frontal plane projection measure: Goniometer measure: 30 seconds chair stand test measure: Overall self-perception by Global Rating of Change Score measure: 9 step stairs climb test. measure: 40-m fast-paced walk test sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: THQ hospital KRK. status: RECRUITING city: Lahore state: Punjab country: Pakistan name: Ayesha Anwar, DPT role: CONTACT phone: 03340003448 email: [email protected] lat: 31.558 lon: 74.35071 hasResults: False
<|newrecord|> nctId: NCT06343896 id: AnkaraCHBilkent-tntaygurt briefTitle: Evaluation of Sedation Depth and Reliability With Integrated Pulmonary Index (IPI) Follow-up in Pediatric Radiological Interventions acronym: IPI overallStatus: RECRUITING date: 2024-04-01 date: 2024-06-15 date: 2024-10-15 date: 2024-04-03 date: 2024-04-05 name: Ankara City Hospital Bilkent class: OTHER briefSummary: In this study, we aimed to investigate the predictability of possible respiratory complications and the effect of the addition of the integrated pulmonary (EPI) score to the evaluation of the patient's respiratory index status in addition to the SPO2 measurement available in standard ASA monitoring in pediatric patients undergoing interventional radiological procedures under sedoanesthesia. conditions: Sedation conditions: BIS conditions: Integrated Pulmonary Index studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 68 type: ESTIMATED name: monitorization reliability measure: EVALUATION OF IPI RELIABILITY IN PEDIATRIC PATIENTS measure: BİS correlation with the IPI measure: pulse oximetry correlation with the IPI measure: noninvasive blood pressure measure: heart rate measure: respiratory rate measure: end tidal carbondioxide measure: apnea and hypoxia conditions that develop in the patient during anesthesia measure: postoperative recovery time measure: intraoperative total dose of medication used measure: postoperative nausea and vomiting sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Ankara City Hospital, Bilkent status: RECRUITING city: Ankara country: Turkey name: tugbanur taygurt role: CONTACT phone: +905322005632 email: [email protected] lat: 39.91987 lon: 32.85427 hasResults: False
<|newrecord|> nctId: NCT06343883 id: 24-353 briefTitle: Investigation of Low-intensity Focused Ultrasound Pressure overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-07 date: 2026-07 date: 2024-04-03 date: 2024-04-03 name: Virginia Polytechnic Institute and State University class: OTHER briefSummary: Investigating the relationship between input pressure of low-intensity focused ultrasound and an evoked potential in both eeg and fMRI. conditions: Somatic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Primary cohort (safety) will be collected prior to full study collection. Primary collection will involve highest pressure application and follow-up safety scans (MRI) to be reviewed by a Neuroradiologist. Once cleared - parallel design will be utilized for eeg and fMRI cohorts. Both cohorts will receive 3 LIFU pressures randomized over 3 study visits. Electrical stimulations will be applied pre and post LIFU administration to induce somatosensory evoked potentials (SEPs). primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: No masking, no sham. All subjects will receive all conditions, all of which are active. count: 25 type: ESTIMATED name: low-intensity focused ultrasound - low pressure name: low-intensity focused ultrasound - medium pressure name: low-intensity focused ultrasound - high pressure measure: Report of Symptoms Questionnaire measure: MRI measure: EEG measure: fMRI sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fralin Biomedical Research Institute at VTC city: Roanoke state: Virginia zip: 24016 country: United States name: Jessica Florig, MPH role: CONTACT phone: 540-526-2261 email: [email protected] name: Wynn Legon, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.27097 lon: -79.94143 hasResults: False
<|newrecord|> nctId: NCT06343870 id: ESTIME briefTitle: Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME) acronym: ESTIME overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2025-01-31 date: 2025-04-30 date: 2024-04-03 date: 2024-04-03 name: University of Sao Paulo General Hospital class: OTHER briefSummary: Estrogen and androgen deficiencies negatively impact the quality of life of women at different stages of life, especially after menopause. New modalities and new therapeutic alternatives have been researched. Parenteral administration of estradiol and testosterone could be effective to treat symptoms secondary to estrogen and androgen deficiencies and minimize these adverse events. This study evaluates the efficiency of subdermal implant-bioabsorbable use in women with menopausal symptoms associated with secondary estrogen and androgen deficiencies in women with natural menopause, premature ovarian failure or surgical menopause due to cervical cancer. Pharmacokinetic, biochemical, metabolic, thromboembolic and hormonal data will be evaluated, as well as the effects on quality of life, menopausal symptoms and sexual function after treatment. conditions: Menopause conditions: Testosterone Deficiency conditions: Estrogen Deficiency studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: testosterone pellet (100 mg) name: Placebo measure: Evaluate hormonal, metabolic thromboembolic and clinical effects on climacteric symptoms measure: Evaluate response in quality of life and sexual function sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06343857 id: CE-AVEC 878/2022/Oss/AOUFe briefTitle: Joint Self-Assessment Forms for Knee, Ankle and Shoulder overallStatus: ACTIVE_NOT_RECRUITING date: 2023-05-01 date: 2024-04-30 date: 2024-04-30 date: 2024-04-03 date: 2024-04-03 name: University Hospital of Ferrara class: OTHER briefSummary: The present study represents the pilot phase of the project aimed at developing anatomical site-specific self-assessment questionnaires (shoulder, knee and ankle) that can advise the subject of the need for an orthopaedic specialist examination.
The pilot phase of the project involves the collection of data from questionnaires in a population of subjects who have requested an orthopaedic consultation for the anatomical site covered by the questionnaire. Each questionnaire consists of questions designed to collect information about the patient's subjective condition.
The data collected from the questionnaires will be used to evaluate the statistical significance (p value) of each question in the questionnaire in relation to the outcome of the orthopaedic specialist visit. Through a multivariate logistic analysis of the answers given by the subject, it will be possible to 'weight' each answer to obtain a final value that gives an indication of an orthopaedic specialist visit. conditions: Osteoarthritis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: self-assessment questionnaire measure: Observation of the distribution of questionnaire responses for each anatomical site. measure: Therapeutic indication of the orthopaedic specialist for each subject participating in the study sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Ortopedico Rizzoli, Clinica Ortopedica e Traumatologica II city: Bologna state: BO country: Italy lat: 44.49381 lon: 11.33875 facility: Unità Operativa di Chirurgia della Spalla I.R.C.C.S. Ospedale Galeazzi-Sant'Ambrogio city: Milan state: MI country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
<|newrecord|> nctId: NCT06343844 id: 49RC23_0070 briefTitle: Disparities in Myocardial Infarction Remodeling According to Gender acronym: REMOVE 2 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2039-09-01 date: 2040-07-01 date: 2024-04-03 date: 2024-04-03 name: University Hospital, Angers class: OTHER_GOV briefSummary: Following myocardial infarction, female individuals demonstrate a poorer prognosis, characterized by elevated rates of mortality and heart failure. A primary hypothesis suggests unfavorable cardiac remodeling in women. This remodeling, defined as alterations in cardiac size and shape post-infarction, necessitates repeated non-invasive imaging for study. conditions: Myocardial Infarction conditions: Ventricular Remodeling studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 1650 type: ESTIMATED name: cardiac imaging to assess left ventricular volumes and function measure: Asses left ventricular remodeling disparities between genders measure: Evaluate the evolution of remodeling at Month 3 measure: Assess remodeling changes between inclusion and Month 12 measure: Assess the prevalence of comorbidities and their impact on the effect on the outcome: post-infarction cardiac remodeling with gender (cardiovascular risk factors, renal function, hepatic functionperipheral artery disease, way of life) measure: Explore prognostic disparities between men and women. measure: Evaluate lifestyle habits up to 10 years: outcome anxiety/depression measure: Evaluate lifestyle habits up to 10 years: outcome diet score measure: Evaluate lifestyle habits up to 10 years: outcome physical activity measure: Assess the risk of remodeling based on specific parameters in female subjects: presence of endometriosis measure: Assess the risk of remodeling based on specific parameters in female subjects: presence of polycystic ovary measure: Assess the risk of remodeling based on specific parameters in female subjects: presence of uterine fibroma measure: Assess the risk of remodeling based on specific parameters in female subjects: presence of hormonal therapy measure: Assess the risk of remodeling based on specific parameters in female subjects: date of first period measure: Assess the risk of remodeling based on specific parameters in female subjects: pregnancy measure: Assess the risk of remodeling based on specific parameters in female subjects: children measure: Assess the risk of remodeling based on specific parameters in female subjects: obstetrical event measure: Assess the risk of remodeling based on specific parameters in female subjects: menopause sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06343831 id: IRB23-1646 briefTitle: Quantitative Assessment of Autologous Fat Transfer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2026-12 date: 2024-04-03 date: 2024-04-03 name: University of Chicago class: OTHER name: National Institutes of Health (NIH) name: University of Houston briefSummary: This is a single-arm, prospective pilot study that will objectively assess outcomes in patients electively undergoing Autologous Fat Transfer (AFT) for breast or chest wall reconstruction. Patients planning to undergo autologous fat transfer for breast or chest wall reconstruction will be enrolled prospectively. Participants will undergo standard photographs (2-D imaging) of their chest wall and torso, including the breasts, and complete a validated questionnaire (BREAST-QTM) to evaluate patient satisfaction, and quality of life, all standard of care. The 3D photographs, Magnetic resonance imaging (MRI), and Ultrasound (US) are routinely used in practice but will be performed for research purposes in this study. All imaging procedures and questionnaires will be obtained at baseline and follow-up visits 3-6. conditions: Autologous Fat Grafting studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients planning to undergo autologous fat transfer for breast or chest wall reconstruction will be enrolled prospectively. Participants will undergo standard photographs (2-D imaging) of their chest wall and torso, including the breasts, and complete a validated questionnaire (BREAST-QTM) to evaluate patient satisfaction, and quality of life, all standard of care. The 3D photographs, MRI, and US are routinely used in practice but will be performed for research purposes in this study. primaryPurpose: OTHER masking: NONE count: 15 type: ESTIMATED name: 2-Dimensional (2-D) Photographs (Visit 1/ Follow up Visit 3-6) name: 3-Dimensional (3-D) Photographs (Visit 1- 6) name: Ultrasound Soft Tissue Assessment (Visit 1/ Follow up Visit 4-6) name: Magnetic Resonance Imaging Volume Assessment (Visit 1/ Follow up Visit 4-6) name: BREAST-QTM questionnaire (Visit 1/ Follow up Visit 4-6) measure: Change from baseline in breast/chest wall following autologous fat grafting, measured by imaging. measure: Change from baseline in quality of life as measured by the BREAST-QTM survey. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06343818 id: NIHR301578 briefTitle: Compassion Project: Developing an Empathy-Based Stress Intervention overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2026-08-01 date: 2027-08-31 date: 2024-04-03 date: 2024-04-03 name: University of Bath class: OTHER name: National Institute for Health Research, United Kingdom name: Oxford Health NHS Foundation Trust name: Central and North West London NHS Foundation Trust briefSummary: Compassion is recognising that someone is suffering and wanting to help them. Compassion fatigue is a reduction in capacity to feel compassion for others. Secondary trauma is the experience of traumatic responses to hearing about someone else's trauma. Burnout is depersonalisation, emotional exhaustion, and feeling less good at one's job. Compassion fatigue, secondary trauma and burnout can all be referred to as empathy-based stress. This is a problem for healthcare staff and their patients.