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The application of radiomics to preoperative ultrasound images could identify BRCA mutated tumors before surgical planning (radiogenomic analysis) and allow a personalized treatment.
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The aim of the study is to validate a predictive model to define the risk of malignancy of adnexal masses that the investigators developed at the Fondazione IRCCS Istituto Nazionale dei Tumori di Milano.
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The model, based on the integration of radiomics and artificial intelligence, uses complex software capable of 'reading' the ultrasound images in a completely automatic way and is able to estimate the risk of malignancy of the mass.
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If the patient decide to participate in the clinical study, the patient will undergo transvaginal ultrasound (eventually supplemented by transabdominal ultrasound in case of large adnexal masses, if the patients are virgo or if the patients will refuse transvaginal approach for any reason). This exam is part of the routine preoperative evaluation for adnexal pathology and therefore the patients don't have to undergo any additional clinical, biochemical or imaging examination, according to national and international guidelines.
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Thereafter, the images stored during the preoperative ultrasound will be exported in anonymous format from the ultrasound system, and sent to the coordinating center (Fondazione IRCCS Istituto Nazionale dei Tumori di Milano). There, images will be submet to radiomic analysis through the application of a dedicated software; that will allow to evaluate the intrinsic characteristics of the tissue according to different parameters (shape, intensity, grade of heterogeneity and many others) of the 'pixels' (gray dots) that constitute the ultrasound image.
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This analysis, once validated, will provide clinicians an additional tool to identify malignant adnexal masses prior to surgery.
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If the final histological diagnosis is of serous epithelial ovarian cancer, through the use of the same radiomics software described above the investigators will try to identify the intrinsic characteristics of the tissue associated with the presence or absence of the BRCA 1 or 2 mutation conditions: Ovarian Cysts conditions: Ovarian Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ACTUAL name: Ultrasound measure: Diagnosis of malignant ovarian tumor sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano city: Milano state: Lombardia zip: 20133 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06342921 id: ADC189-2022-01 briefTitle: ADC189 Tablets on Influenza A Virus Infection/Influenza B Virus Infection acronym: ADC overallStatus: RECRUITING date: 2022-12-07 date: 2024-06-30 date: 2024-06-30 date: 2024-04-02 date: 2024-04-02 name: Jiaxing AnDiCon Biotech Co.,Ltd class: INDUSTRY briefSummary: The goal of this Phase II/III study is to investigate the safty and efficacy of ADC189 tablets in adolescents and adults with influenza A virus infection/influenza B virus infection.
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The main aim to answer:
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* Phase II study is to evaluate the efficacy of ADC189 tablets in the treatment of adult influenza subjects and determine the optimal therapeutic dose by analyzing the time of virus titer turning to negative. All the results will be used to design the Phase III study.
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* Phase III study is to evaluate the efficacy of ADC189 tablets by analyzing the duration of remission of all influenza symptoms in adolescents and adults subjects with influenza.
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Participants will be taken ADC189 teblets/Placebo once, and be observed by 22 days.
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Phase II study has 3 groups: 15 mg ADC189; 45 mg ADC189; and Placebo; Phase III study has 2 groups: 45 mg ADC189; and Placebo. conditions: Safety Issues conditions: Effect of Drug studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 675 type: ESTIMATED name: 15 mg ADC189 name: 45 mg ADC189 name: Placebo measure: the severity of influenza measure: the safety of study drug sex: ALL minimumAge: 12 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Rui Jin Hospital status: RECRUITING city: Shanghai state: Shanghai country: China name: Haili Liu, Dr role: CONTACT phone: +862134188900 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06342908 id: 23-001700 id: NCI-2024-00210 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) briefTitle: A Vaccine (Neoantigen-Targeted ppDC) for the Treatment of H3 G34-mutant Diffuse Hemispheric Glioma overallStatus: NOT_YET_RECRUITING date: 2024-05-08 date: 2027-03-08 date: 2028-01-09 date: 2024-04-02 date: 2024-04-02 name: Jonsson Comprehensive Cancer Center class: OTHER briefSummary: This phase I trial tests the safety and side effects, and best dose of a vaccine (neoantigen-target ppDC) in treating patients with H3 G34-mutant diffuse hemispheric glioma. Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Giving neoantigen-targeted ppDC may be safe, tolerable and/or effective in treating patients with diffuse hemispheric glioma with a H3 G34 mutation. conditions: Diffuse Hemispheric Glioma, H3 G34-Mutant studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Biospecimen Collection name: Dendritic Cell Therapy name: Leukapheresis name: Magnetic Resonance Imaging name: Poly ICLC measure: Incidence of regimen-limiting toxicities measure: Significant increase in gamma-interferon (IFN) gene expression signature measure: Significant clonal T cell expansion measure: Targets of clonal cytotoxic T cell expansion measure: Pro-inflammatory phenotypic changes in immune cell populations measure: Changes in immune cell subset expansion and contraction in T cell and myeloid-derived cell populations measure: Changes of immune cell markers profile in T cell and myeloid-derived cell populations sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: UCLA / Jonsson Comprehensive Cancer Center city: Los Angeles state: California zip: 90095 country: United States name: Sichen C. Li role: CONTACT phone: 310-592-9091 email: [email protected] name: Anthony C. Wang, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False
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<|newrecord|> nctId: NCT06342895 id: 2020_1113 id: 2022-A00103-40 type: OTHER domain: ID-RCB number, ANSM briefTitle: Interpretation and Optimization of Nutrition in the Intensive Care Units acronym: IONIC overallStatus: RECRUITING date: 2024-04-10 date: 2025-04 date: 2025-09 date: 2024-04-02 date: 2024-04-25 name: Dim3 class: INDUSTRY name: Baxter Healthcare Corporation name: University Hospital, Lille briefSummary: Despite recommendations, inadequate nutritional intake in intensive care unit (ICU) patients remains frequent and can lead to complications such as infections, increased length of stay, prolonged weaning from ventilation, increased long-term mortality, and decreased quality of life after intensive care. Studies have shown that patients only receive up to 50-60% of prescribed calories and proteins due to many factors leading to nutritional support interruptions such as ICU procedures, physical therapy, transport for imaging or invasive procedures outside the ICU, and nutrition intolerance.
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Furthermore, this discrepancy between prescribed and delivered nutrition may go largely unnoticed, due to issues concerning inadequate manual or automated monitoring of delivered nutrition. A joint "Call to Action" by ASPEN, the Academy of Nutrition and Dietetics, and the American Society of Health-System Pharmacists stated that parenteral nutrition errors and their contributing factors could be prevented by improving the functionality of in-house Clinical Decision Support Systems and the interfaces between electronic health records (EHRs), automated preparation devices and pharmacy systems.
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Nutrow® is a software package designed to support nutritional management based on the calculation of recommended calorie and protein requirements, real-time calculation and monitoring of calorie and protein prescriptions, real-time calculation and monitoring of calories and protein truly delivered to patients, and information feedback to prescribers. Feedim® is a Medical Device Data System (MDDS), designed by Dim3, which transmits information from enteral feeding pumps to third-party software, such as Nutrow®.
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The aim of the study is to assess whether the joint use of Nutrow-Feedim improves the achievement of nutritional objectives in ICU patients prior to oral intake by reducing the discrepancy between prescribed and delivered calories and protein. conditions: Nutritional Support studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Usual use of standard clinical and biological information related to nutritional support as available through the ICU electronic health record (i.e. without any calculated information on recommended, prescribed, or received calories and protein, only information on prescribed products and volumes as collected by and presented in the ICU EHR) In this arm, participants, investigators, and healthcare professionals will be blinded to real-time enteral feed volumes that will be collected by the Feedim medical device and transmitted to the electronic study case report form. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 144 type: ESTIMATED name: Nutritional support prescription and delivery monitoring feedback name: Usual care measure: Mean total daily calories delivered/prescribed ratio (percent) measure: Mean total daily protein delivered/prescribed ratio (%) measure: Mean total daily calories delivered/recommended ratio (percent) measure: Mean total daily protein delivered/recommended ratio (percent) measure: Nutritional support duration (days) measure: Time to initiation of nutritional support (days) measure: Weight (Kg) measure: Day 28 mortality rate measure: ICU length-of-stay (days) measure: Days on ventilator (days) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Lille status: RECRUITING city: Lille zip: 59037 country: France name: Eric KIPNIS, MD, PhD role: CONTACT phone: +33 (0)3 20 44 59 62 email: [email protected] lat: 50.63297 lon: 3.05858 hasResults: False
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<|newrecord|> nctId: NCT06342882 id: GO 19/833- A briefTitle: Dysphagia Severity and Functional Independence Level overallStatus: COMPLETED date: 2020-01-01 date: 2024-01-01 date: 2024-02-01 date: 2024-04-02 date: 2024-04-02 name: Atılım University class: OTHER briefSummary: Functional independence is the ability of a person to perform daily life activities safely without any restriction, as much as possible. The functional independence depends on physical, social, cognitive and psychological abilities of the person. Therefore, full functional independence requires the harmony of all these parameters.
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Dysphagia can be seen in more than 50% of neurological patients, and it is called neurogenic dysphagia. Muscle weakness, tonus changes, sensory loss and coordination problems occur in these patients. Pain and fatigue are also frequently observe. These patients have problems with fine and gross motor movements, and thereby mobility and transfer activities become difficult. Life-threatening complications such as pulmonary problems, malnutrition and dehydration accompany when patients have dysphagia. Both neurological and dysphagia-related problems negatively affect the physical, psychological, emotional and cognitive functions of patients. Neurological patients with dysphagia may have more serious clinical situations due to more affected vital functions such as pulmonary functions and feeding.
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Dysphagia-induced malnutrition adversely affects many systems, including the musculoskeletal system. In a study conducted in the elderly with dysphagia, atrophy in the total muscle mass and swallowing muscles, and increase in intramuscular adipose tissue were reported as a result of malnutrition. Decreases in the muscle mass may negatively affect the functional independence of patients with dysphagia. Other studies in geriatric population have shown that swallowing function is associated with hand grip strength and quadriceps muscle strength, which are indicators of functional independence in activities of daily living (ADL). These studies also suggest that dysphagia may be associated with functional independence in geriatric group. Therefore, functional independence may also reduce in patients with neurogenic dysphagia. However, there is no study investigating the relationship between dysphagia severity and the functional independence levels in patients with neurological diseases. Therefore, the investigators aimed to investigate the relationship between dysphagia severity and functional independence level in patients with neurological diseases. conditions: Dysphagia conditions: Neurologic Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 30 type: ACTUAL name: dysphagia assessment name: functional independence level measure: dysphagia severity measure: functional independence sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Atılım Uiveristy city: Ankara state: Incek zip: 06830 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06342869 id: 690 briefTitle: Comparison of the Effects of Lidocaine and Articaine Used for Buccal Infiltration and Supplemental Palatinal Infiltration Anesthesia in Teeth With Irreversible Pulpitis overallStatus: COMPLETED date: 2022-04-01 date: 2022-10-01 date: 2022-12-01 date: 2024-04-02 date: 2024-04-02 name: Akdeniz University class: OTHER briefSummary: Objective: The aim of this study was to compare the effects of articaine or lidocaine in buccal infiltration or palatal infiltration in addition to buccal infiltration in maxillary first or second molars with irreversible pulpitis.
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Method: Among the patients who applied to Akdeniz University Faculty of Dentistry Endodontic Clinic for the treatment of maxillary molars with irreversible pulpitis, 80 volunteers who met the criteria were included in the study. Eighty patients were divided into 4 groups (n = 20). 1. group buccal infiltration with 4% articaine containing 1:100,000 epinephrine, 2. group buccal infiltration with 2% lidocaine containing 80,000 epinephrine, 3. group buccal and palatinal infiltration with 4% articaine containing 1:100,000 epinephrine, 4.group buccal and palatinal infiltration with 2% lidocaine containing 80.000 epinephrine. Pain during the endodontic procedure was determined and recorded according to the Heft Parker visual analog scale. conditions: Fist and Second Molars With ırreversible Pulpitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ACTUAL name: Anesthesia measure: Assessment of complementary palatinal anesthesia with VAS sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Akdeniz University city: Antalya zip: 07070 country: Turkey lat: 36.90812 lon: 30.69556 hasResults: False
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<|newrecord|> nctId: NCT06342856 id: idiopathic infertility briefTitle: Evaluation of Treatment With Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile Men With Idiopathic Oligoasthenoteratospermia acronym: infertility overallStatus: RECRUITING date: 2023-06-15 date: 2024-06-01 date: 2024-07-01 date: 2024-04-02 date: 2024-04-02 name: Ain Shams University class: OTHER briefSummary: Evaluation of treatment with Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile men with Idiopathic Oligoasthenoteratospermia conditions: Infertility Unexplained conditions: Oligospermia studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: co enzyme Q10 , L- Carnitine measure: Changes in Semen analysis parameters compared to baseline measure: Serum hormone levels ([FSH], [LH], testosterone, and prolactin) levels compared to baseline and Cost analysis sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ain Shams University status: RECRUITING city: Cairo zip: 002 country: Egypt name: ahmed ma maher, lecturer role: CONTACT phone: 01013340534 email: [email protected] lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06342843 id: SPLAsH id: NL81395.075.22 type: OTHER domain: CCMO briefTitle: Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty (SPLAsH) acronym: SPLAsH overallStatus: RECRUITING date: 2024-02-13 date: 2026-08-30 date: 2026-11-30 date: 2024-04-02 date: 2024-04-02 name: Isala class: OTHER briefSummary: This study will compare postoperative pain, health related quality of life (HRQoL), function, rehabilitation, urinary incontinence, muscle atrophy and component positioning in total hip arthroplasty (THA) using the posterolateral approach (PLA) or the direct superior approach (DSA). In addition, the CT images will be used to validate a new metal artefact reduction technique. conditions: Osteoarthritis, Hip studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: multicenter, prospective, double blinded, randomized controlled intervention study primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 211 type: ESTIMATED name: Total Hip Arthroplasty measure: Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form measure: Numeric Rating Scale (NRS) measure: Short Form-12 (SF-12) measure: Hip disability and Osteoarthritis Outcome Score (HOOS) measure: Euro Quality of Life (EQ-5D) measure: Global Rating of Change scale measure: Timed Up and Go test (TUG test) measure: 40 meter self-paced walk test for hip osteoarthritis measure: Stair climb test measure: Step count application on iPhone measure: Muscle atrophy by using Computer Tomography (CT) scanner measure: Computer Tomography (CT) image with orthopedic metal artefact reduction (O-MAR) measure: Postoperative cup position on Computer Tomography (CT) image measure: Comparing definite cup position with preoperative planned cup position measure: Comparing definite component position with surgeon's perioperative estimation of component position measure: overall image quality measure: image diagnostic confidence measure: metal artifacts on images measure: Incontinence Severity Index (ISI) measure: Urinary Distress Inventory, Short Form (UDI-6) measure: Patient Global Impression of Severity (PGIS) measure: Incontinence Impact Questionnaire Short Form (IIQ-7) measure: Incontinence after Total Hip Arthroplasty sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amphia status: NOT_YET_RECRUITING city: Breda state: Brabant zip: 4818CK country: Netherlands name: Stefan BT Bolder, MD role: CONTACT lat: 51.58656 lon: 4.77596 facility: Medisch Centrum Leeuwarden status: NOT_YET_RECRUITING city: Leeuwarden state: Friesland zip: 8934AD country: Netherlands name: Wierd Zijlstra, MD/PhD role: CONTACT lat: 53.20139 lon: 5.80859 facility: Isala status: RECRUITING city: Zwolle state: Overijssel zip: 8000 GK country: Netherlands name: Diederik de Boer, MSc. role: CONTACT phone: 00316248117 email: [email protected] name: Roelina Munnik, PhD role: CONTACT phone: 00316245375 email: [email protected] name: Harmen Ettema, MD/PhD role: PRINCIPAL_INVESTIGATOR lat: 52.5125 lon: 6.09444 hasResults: False
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<|newrecord|> nctId: NCT06342830 id: End 20-05 P briefTitle: Comparing the Effect of Different Intracanal Dressing on Failed Root Canal Treated Cases on Periapical Healing overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-05 date: 2024-04-02 date: 2024-04-08 name: Ain Shams University class: OTHER briefSummary: The goal of this clinical trial is to compare the effects of different intracanal medication between endodontic retreatment visits in previously failed root canal treatment patients (single root canal anteriors or premolars teeth). The main question it aims to answer are:
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* Is natural and synthetic intracanal Medicament effective in reducing or complete healing of Periapical lesions or not? the researchers will compare the effect of different intracanal dressing including:
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* nanocurcumin gel
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* curcumin gel
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* ciprofloxacin +ibuprofen gel
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* calcium hydroxide Paste as control group in between the endodontic retreatment visits to see if these medicaments work well on periapical lesion healing this outcome measured by Cone beam CT at base and after 6 months follow up periods conditions: Periapical Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: nanocurcumin gel name: Curcumin Gel name: Ciprofloxacin 500 mg +ibuprofen 400mg name: Metapaste [calcium hydroxide paste (control group)] measure: healing of periapical lesion measure: antibacterial effect (CFU) measure: Interappointment Pain sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: faculty of dentistry, Ain shams university city: Cairo zip: 11512 country: Egypt name: Rawda Baghdady role: CONTACT phone: 01142361074 email: [email protected] name: sarah H Fahmy role: CONTACT phone: 01005267999 name: Rawda M Baghdady, PHD student role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2020-09-20 uploadDate: 2024-03-01T05:02 filename: Prot_SAP_000.pdf size: 719008 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2020-09-20 uploadDate: 2024-03-01T05:04 filename: ICF_001.pdf size: 284949 hasResults: False
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<|newrecord|> nctId: NCT06342817 id: UFFS briefTitle: Effects of Meditation on Sleep Quality of Medical Students overallStatus: RECRUITING date: 2023-10-18 date: 2024-06-30 date: 2024-06-30 date: 2024-04-02 date: 2024-04-02 name: Universidade Federal da Fronteira Sul class: OTHER briefSummary: The objective of the study is to evaluate the effect of an 8-week online mindfulness-based meditation program on quality sleep status of undergraduate students medicine in the city of Passo Fundo/RS and Chapecó/SC In addition to sleep quality, secondary outcomes such as mindfulness, symptoms of depression, stress, anxiety and burnout will also be assessed conditions: Sleep Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Those students interested in participating in the study will leave their contact details (telephone and email) to the research coordinator, to whom it will be sent an online questionnaire containing the inclusion and exclusion criteria, and the free consent form through the Google forms platform. Collection instruments will only be made available after fulfilling the inclusion criteria and absence of exclusion criteria and agreement with the consent form. Responders will be randomly randomized 1:1 and subsequently communicated whether they will participate in the intervention group or the control group. primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: Responders will be randomly randomized 1:1 and subsequently communicated whether they will participate in the intervention group or the control group. count: 136 type: ESTIMATED name: online mindfulness based meditation program measure: Change in the quality of sleep of medical students on weeks 5, 9 and 17 by the PSQI and ESE measure: Change in the awareness of medical students on weeks 5, 9 and 17 by the MAAS measure: Change in the depression, anxiety and stress symptoms of medical students on weeks 5, 9 and 17 by the DASS-21 measure: Change in the burnout symptoms of medical students on weeks 5, 9 and 17 by CBI-S sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universidade Federal Da Fronteira Sul status: RECRUITING city: Passo Fundo state: RS zip: 99010200 country: Brazil name: Tiago T Simon, MD role: CONTACT phone: +5554991843384 email: [email protected] lat: -28.26278 lon: -52.40667 hasResults: False
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<|newrecord|> nctId: NCT06342804 id: GIB-01-02-2023 briefTitle: Food Effect on the Bioavailability of 4-MUST, Tablets, 128 mg overallStatus: RECRUITING date: 2024-03-19 date: 2024-12-31 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: Valenta Pharm JSC class: INDUSTRY briefSummary: Primary objective of the study: evaluation of the effect of food intake on the bioavailability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets).
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Additional aim of the study: evaluation of pharmacokinetic parameters, safety and tolerability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets). conditions: Cholecystitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 24 type: ESTIMATED name: 4-MUST, 2 tablets, fasted name: 4-MUST, 2 tablets, after meals measure: Pharmacokinetics - Cmax measure: Pharmacokinetics - tmax measure: Pharmacokinetics - AUC0-t measure: Pharmacokinetics - AUC0-inf measure: Pharmacokinetics - AUC ratio measure: Pharmacokinetics - t1/2 measure: Pharmacokinetics - kel measure: Pharmacokinetics - MRT measure: Pharmacokinetics - Vd measure: Pharmacokinetics - Cmax/AUC0-t measure: Pharmacokinetics - f' measure: Pharmacokinetics - f'' measure: Bioavailability - ratio of Cmax measure: Bioavailability - ratio of AUC0-t measure: Bioavailability - ratio of AUC0-inf measure: Adverse event type measure: Adverse event frequency measure: Adverse event severety measure: Drop-outs associated with adverse events sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Federal Budgetary Institution of Science "North-Western Scientific Center for Hygiene and Public Health" status: RECRUITING city: Saint Petersburg zip: 191036 country: Russian Federation name: Elena S Shalukho, MD role: CONTACT phone: +7 (903) 099 57 86 email: [email protected] lat: 59.93863 lon: 30.31413 hasResults: False
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<|newrecord|> nctId: NCT06342791 id: 004349 briefTitle: Effect of Laser Acupuncture on Menstrual Back Pain overallStatus: RECRUITING date: 2024-02-20 date: 2024-05-20 date: 2024-06-20 date: 2024-04-02 date: 2024-04-02 name: Cairo University class: OTHER briefSummary: effect of laser acupuncture on menstrual back pain conditions: Laser Acupuncture conditions: Low Back Pain conditions: Menstruation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: two groups primaryPurpose: TREATMENT masking: SINGLE maskingDescription: laser acupuncture whoMasked: PARTICIPANT count: 32 type: ESTIMATED name: laser acupuncture measure: back Pain intensity during menstruation measure: pain threshold measure: Ability to perform daily activities measure: back Pain intensity during menstruation measure: pain threshold measure: Ability to perform daily activities sex: FEMALE minimumAge: 20 Years maximumAge: 30 Years stdAges: ADULT facility: Faculty of physical therapy cairo university status: RECRUITING city: Cairo zip: 37617692 country: Egypt name: Mai Ali Galal El sayed role: CONTACT phone: 01152457470 email: [email protected] lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06342778 id: DIP-05-02-2023 briefTitle: Pharmacokinetics and Bioequivalence of Doxylamine+Pyridoxine and Diclectin overallStatus: RECRUITING date: 2024-02-27 date: 2024-12-31 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: Valenta Pharm JSC class: INDUSTRY briefSummary: Comparative study of pharmacokinetics and bioequivalence of the study drug Doxylamine + Pyridoxine, enteric-soluble, film-coated tablets, 10 mg + 10 mg (Valenta Pharm JSC, Russia), and reference drug Diclectin, delayed-release tablets, 10 mg + 10 mg (registration certificate holder - Tzamal Bio-Pharma, Israel, manufacturer - Duchesnay Inc, Canada) in healthy volunteers after meals conditions: Nausea studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 28 type: ESTIMATED name: Doxylamine + Pyridoxine name: Diclectin measure: Pharmacokinetics - Cmax measure: Pharmacokinetics - tmax measure: Pharmacokinetics - AUC0-t measure: Pharmacokinetics - AUC0-inf measure: Pharmacokinetics - AUCextr measure: Pharmacokinetics - t1/2 measure: Pharmacokinetics - kel measure: Pharmacokinetics - MRT measure: Bioequivalence - ratio of Cmax measure: Bioequivalence - ratio of AUC0-t measure: Bioequivalence - ratio of AUC0-inf measure: Adverse event type measure: Adverse event frequency measure: Adverse event severety sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation status: RECRUITING city: Yaroslavl zip: 150000 country: Russian Federation name: Sergey M Noskov, Prof. role: CONTACT phone: +7-4852-242332 email: [email protected] lat: 57.62987 lon: 39.87368 hasResults: False
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<|newrecord|> nctId: NCT06342765 id: SV009 briefTitle: Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment acronym: FixedD3 overallStatus: RECRUITING date: 2022-09-22 date: 2028-05-30 date: 2028-05-30 date: 2024-04-02 date: 2024-04-03 name: SpineVision class: INDUSTRY name: Slb Pharma briefSummary: The goal of this observational study is to confirm the safety and performance of the three (3) Spinevision posterior fixations systems Lumis®, Plus® and Ulis® , in the treatment of patient suffering from thoracolumbar spinal degenerative pathologies, or degenerative disc disease (disease that occurs when the spinal disk break down) associated pathologies.
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Part of their standard of care, participants will be questioned on their back and leg pains, their disability and if they have encountered any adverse effects since the Spinevision posterior fixation system implant surgery. Those data will be collected up to twenty four (24) months after the Spinevision posterior fixation system implant surgery. conditions: Intervertebral Disc Degeneration studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 330 type: ESTIMATED name: Pedicle fixation surgery measure: Incidence of serious and non-serious device- and/or procedure-related adverse events measure: Change of the Oswestry Disability Index (ODI) measure: Fusion success measure: Change of the Oswestry Disability Index (ODI) measure: Change of the back and leg Visual Analogue Score (VAS) measure: Incidence of revision surgery at implant site sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: DOSCEA Pôle Rachis status: RECRUITING city: Bayonne zip: 64100 country: France name: Jean Bernard role: CONTACT email: [email protected] lat: 43.48333 lon: -1.48333 facility: Clinique du dos Bordeaux-Terrefort status: RECRUITING city: Bruges zip: 33520 country: France name: Louis Boissière, Doctor role: CONTACT email: [email protected] lat: 44.87981 lon: -0.61219 facility: Orthéo Neurochirurgie status: RECRUITING city: Saint-Étienne zip: 42199 country: France name: Benjamin Pommier, Doctor role: CONTACT email: [email protected] lat: 45.43389 lon: 4.39 hasResults: False
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<|newrecord|> nctId: NCT06342752 id: 6007 briefTitle: The Role of VOCs, Airway Mucins and Airway Microbiome in Bronchopulmonary Dysplasia acronym: INFANCY overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-09 date: 2027-09 date: 2024-04-02 date: 2024-04-02 name: University Hospital, Antwerp class: OTHER briefSummary: Bronchopulmonary dysplasia (BPD), the most common respiratory complication of extremely preterm birth, significantly impacts healthcare with high morbidity and mortality rates.
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Despite the well-established primordial role of inflammation and oxidative stress in the development of BPD, clinical practice does not incorporate the testing for biomarkers associated with the development of BPD. The diagnosis of BPD based on required respiratory support at 36 weeks PML, stresses the need for an early prediction tool which could identify patients with high levels of these biomarkers. This on its turn, could also improve treatment approaches in clinical practice which are currently mostly supportive or non-specific and do not target underlying pathophysiologic pathways.
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Secondly, mucin expression aim to play a rol in other respiratory diseases, whereas in BPD only the potential role of MUC1 was explored.
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Thirdly, the composition of the airway microbial composition of an infant is assumed to be influenced by different factors. From early on in pregnancy the airway microbiome of the infant is formed, offering a protective role against pathologies. On the other hand, the role of the airway microbiome in the development of BPD remains unclear and needs to be elucidated.
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The threefold aim of this study is as follows:
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I. The development of a non-invasive breath test that allows early detection of bronchopulmonary dysplasia, using the potential of VOCs in exhaled breath as biomarkers for inflammation and oxidative stress.
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II. The exploration of the composition and diversity of the airway microbiome in infants with BPD, their association with exhaled VOCs and the exploration of the placental and vaginal microbiome.
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III. The detection of potential alterations in airway mucin expression in BPD patients.
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Through this comprehensive approach, we seek to gain a deeper understanding of how these mutual associations may contribute to the later development of BPD.
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In total 140 preterm infants, including 70 BPD patients and 70 preterm controls, born below 30 weeks' gestation at the Antwerp University Hospital will be included. conditions: Bronchopulmonary Dysplasia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 140 type: ESTIMATED name: Breath test name: Throat swabs name: Placental samples name: Vaginal swab name: Endotracheal aspirates measure: Exhaled breath Volatile Organic Compounds (VOCs) measure: Airway mucin profiles measure: Airway microbial profiles measure: Placental headspace VOCs measure: Placental microbiome measure: Vaginal microbiome measure: Follow-up structural lung imaging measure: Hypercapnia sex: ALL minimumAge: 0 Days maximumAge: 3 Days stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06342739 id: IEO 1595 briefTitle: Verbal Synchrony, Satisfaction and Decision-making in Face-to-face Consultations overallStatus: RECRUITING date: 2022-03-23 date: 2024-12-31 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: European Institute of Oncology class: OTHER briefSummary: Eligible participants will be: benign thyroid nodules patients, to be involved in a consultation with their endocrinologist and/or surgeon and/or radiologist, in order to discuss treatment options related to benign thyroid nodules. conditions: Thyroid Nodule studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: Evaluation of predictive power of verbal synchrony established between patient and physician during the consultation on patients' satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Gabriella Pravettoni role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06342726 id: 2024/714469 briefTitle: The Effect of Active External Rewarming on Rewarming Rate in Simulated Prehospital Accidental Hypothermia overallStatus: RECRUITING date: 2024-05-28 date: 2024-06-02 date: 2024-06-02 date: 2024-04-02 date: 2024-04-02 name: Haukeland University Hospital class: OTHER briefSummary: In this study, we aim to compare the effect of active external rewarming to passive rewarming in healthy research participants on core temperature.
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The participants will be cooled to a core temperature of 35 degress C, the rewarmed using 2 different scenarios. Scenario 1 will be with passive rewarming, scenario 2 with active rewarming. Shivering will be pharmacologically inhibited using Buspirone and Meperidine. conditions: Accidental Hypothermia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study will use a crossover design on where research participants will undergo repetitions of the same scenario with different interventions in order to serve as their own control. The research participants will be healthy volunteers providing both oral and written consent.
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Before the start of experiment, the research participant will be cooled in an ice cave wearing wet clothing and with 2-3 m/s wind to a core temperature of 35.0 °C using the established protocol for inhibition of shivering. The maximum cooling time will be 2 hours (120 minutes). The order of interventions will be randomized.
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When the research subjects reach the target temperature of 35.0°C or the maximum cooling time of 2 hours, they will be subjected to one of the two scenarios listed below, with a rewarming phase of maximum 60 minutes. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 12 type: ESTIMATED name: PAX Warming Blanket name: Passive insulation measure: Core body temperature sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Haukeland University Hospital status: RECRUITING city: Bergen zip: 5021 country: Norway name: Sigurd Mydske, MD role: CONTACT phone: 90659586 email: [email protected] name: Øyvind Thomassen, MD, PhD role: CONTACT phone: 977 18 721 email: [email protected] lat: 60.39299 lon: 5.32415 hasResults: False
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<|newrecord|> nctId: NCT06342713 id: BGB-45035-101 briefTitle: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 overallStatus: NOT_YET_RECRUITING date: 2024-05-28 date: 2025-04-30 date: 2025-04-30 date: 2024-04-02 date: 2024-04-02 name: BeiGene class: INDUSTRY briefSummary: This study is the first-in-human (FIH) study for BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different dose levels in healthy participants.
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Study details include:
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* The study duration will be up to 16 months.
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* The treatment duration will be up to 14 days.
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* Safety follow-up 30 days after last dose of study drug. conditions: Healthy Participants conditions: Healthy Subjects conditions: Healthy Volunteers conditions: Autoimmune Diseases conditions: Healthy Adult Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The cohorts in Part A, B, and C will be double-blinded, while the food effect study in Part D will be open-label whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 92 type: ESTIMATED name: BGB-45035 name: Placebo measure: Number of Participants Experiencing Adverse Events (AEs) measure: Number of participants with clinically significant changes from baseline in clinical laboratory values measure: Number of participants with clinically significant changes from baseline in vital signs measure: Number of participants with clinically significant changes from baseline in cardiac conduction intervals measure: Area under the plasma concentration time curve from time zero to last quantifiable time(AUClast) measure: Area under the plasma concentration time curve from time zero to infinite time (AUCinf) measure: Area under the plasma concentration time curve from time zero to end of dosing interval (AUCtau) measure: Maximum observed plasma concentration (Cmax) measure: Time to maximum plasma concentration (Tmax) measure: Trough plasma concentration (Ctrough) measure: Half life (t½) measure: Apparent systemic clearance (CL/F) measure: Apparent volume of distribution (Vz/F) measure: Accumulation Ratios sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06342700 id: PKM18138 id: U1111-1299-1906 type: REGISTRY domain: ICTRP briefTitle: A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants overallStatus: RECRUITING date: 2024-03-25 date: 2024-04-29 date: 2024-04-29 date: 2024-04-02 date: 2024-04-11 name: Sanofi class: INDUSTRY briefSummary: This is a cross-over, Phase 1, 4-arm study. The purpose of this study is to measure the relative bioavailability and food effect of crystalline formulation rilzabrutinib and amorphous formulation rilzabrutinib in healthy male and female participants aged 18 to 55 years of age.
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The total study duration per participant is expected to be up to 36 days, including:
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* Screening: up to 4 weeks
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* Treatment periods: once successfully screened, enrolled participants will be randomized to 1 of 4 treatment sequences with 4 single dose treatment periods.
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* Washout: One day washout is planned after each treatment period hence providing 2 days between doses.
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* Safety follow-up: participants will be asked to participate in an end-of-study safety assessment upon discharge from the clinical study unit, ie, on Day 8 of the study. conditions: Autoimmune Disorder conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 28 type: ESTIMATED name: Rilzabrutinib crystalline form name: Rilzabrutinib amorphous form measure: Relative bioavailability as assessed by rilzabrutinib Cmax following administration of the test and reference formulations in the fasted state measure: Relative bioavailability as assessed by rilzabrutinib AUClast following administration of the test and reference formulations in the fasted state measure: Relative bioavailability as assessed by rilzabrutinib AUC following administration of the test and reference formulations in the fasted state measure: Relative bioavailability as assessed by rilzabrutinib Cmax following administration of the test and reference formulations in the fed state measure: Relative bioavailability as assessed by rilzabrutinib AUClast following administration of the test and reference formulations in the fed state measure: Relative bioavailability as assessed by rilzabrutinib AUC following administration of the test and reference formulations in the fed state measure: Food effects as assessed by rilzabrutinib Cmax following administration of the test and reference formulations under the fed versus fasted state measure: Food effects as assessed by rilzabrutinib AUClast following administration of the test and reference formulations under the fed versus fasted state measure: Food effects as assessed by rilzabrutinib AUC following administration of the test and reference formulations under the fed versus fasted state measure: Number of participants with adverse events, treatment-emergent adverse events, serious adverse events and adverse events of special interest sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Nucleus Network Site Number : 8400001 status: RECRUITING city: Saint Paul state: Minnesota zip: 55114 country: United States lat: 44.94441 lon: -93.09327 hasResults: False
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