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2. Characterize the FMD pre or post dialysis and according to the duration of the long (for example between Thursday and Sunday) vs. short (between Tuesday and Thursday) inter-dialytic period.
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3. Evaluate the relationship between endothelial dysfunction according to FMD, aPL positivity and arteriovenous fistula complications in hemodialysis patients.
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4. Evaluate the risk factors associated with endothelial dysfunction according to FMD, and in particular evaluate the impact of antiphospholipid antibodies.
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5. Evaluate the correlation between endothelial dysfunction according to FMD and other markers of endothelial dysfunction (urinary NO and metabolites of urinary NO, PGI2, endothelin, PGH2). conditions: Chronic Renal Failure studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 200 type: ESTIMATED name: Urine sampling name: Blood sampling name: Flow mediated dilatation test measure: Nitric oxide (NO) plasma level measure: Endothelin 1 (ET-1) plasma level measure: E-Selectine plasma level measure: P-Selectine plasma level measure: Intercellular Adhesion Molecule 1 (ICAM-1) plasma level measure: Interleukin 6 (IL-6) plasma level measure: Nitric oxide (NO) urine concentration measure: Endothelin 1 (ET-1) urine concentration measure: Tumour Necrosis Factor alpha (TNF alpha) urine concentration measure: Interleukin 6 (IL-6) urine concentration measure: Flow mediated dilatation test result (%) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brugmann University Hospital status: RECRUITING city: Brussels zip: 1020 country: Belgium name: Maxime Taghavi, MD PhD role: CONTACT email: [email protected] lat: 50.85045 lon: 4.34878 hasResults: False
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<|newrecord|> nctId: NCT06347016 id: AROAPOC3-3004 id: 2023-509301-80 type: EUDRACT_NUMBER briefTitle: Study of Plozasiran in Adults With Severe Hypertriglyceridemia acronym: SHASTA-4 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-07 date: 2026-10 date: 2024-04-04 date: 2024-04-16 name: Arrowhead Pharmaceuticals class: INDUSTRY briefSummary: This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo, and be evaluated for efficacy and safety. After Month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol. conditions: Severe Hypertriglyceridemia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Plozasiran Injection name: Placebo measure: Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo measure: Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo measure: Proportion of Subjects Who Achieve Fasting TG Levels of < 500 mg/dL (<5.65 mmol/L) at Month 10 and Month 12 measure: Adjudicated Abdominal Clinical Event Rate (Including Emergency Room Visits or Hospitalizations for Abdominal Pain Attributed to Hypertriglyceridemia and Events of Documented Pancreatitis) During the Treatment Period Compared to Placebo at Month 12 measure: Proportion of Subjects Who Achieve Fasting TG Levels of <150mg/dL (<1.69 mmol/L) at Month 10 and Month 12 Compared to Placebo measure: Number of Subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo measure: Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment measure: Incidence Rates of Impaired Glucose Tolerance Throughout the Course of Treatment measure: Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment measure: Change from Baseline in Hemoglobin A1c (HbA1c) and Other Glycemic Control Parameters During the Treatment Period Compared to Placebo measure: Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo measure: Change from Baseline in C-Peptide During the Treatment Period Compared to Placebo measure: Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo measure: Change from Baseline in Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) Associated with Worsening Glycemic Control During the Treatment Period Compared to Placebo measure: Initiation of New Medication for Hyperglycemia among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo measure: Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo measure: Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Subjects Receiving Plozasiran Over Time Through Month 12 measure: Titers of Anti-drug Antibodies (ADA) to Plozasiran in Subjects Receiving Plozasiran Over Time Through Month 12 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06347003 id: AROAPOC3-3003 id: 2023-509300-14 type: EUDRACT_NUMBER briefTitle: Phase 3 Study of Plozasiran in Adults With Severe Hypertriglyceridemia acronym: SHASTA-3 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-07 date: 2026-10 date: 2024-04-04 date: 2024-04-04 name: Arrowhead Pharmaceuticals class: INDUSTRY briefSummary: This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo, and be evaluated for efficacy and safety. After month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol. conditions: Severe Hypertriglyceridemia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 405 type: ESTIMATED name: Plozasiran Injection name: Placebo measure: Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo measure: Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo measure: Proportion of Participants Who Achieve Fasting TG Levels of <500 mg/dL (<5.65 mmol/L) at Month 10 and Month 12 Compared to Placebo measure: Adjudicated Abdominal Clinical Event Rate (Including Emergency Room Visits or Hospitalizations for Abdominal Pain Attributed to Hypertriglyceridemia and Events of Documented Pancreatitis) During the Treatment Period Compared to Placebo at Month 12 measure: Proportion of Participants Who Achieve Fasting TG Levels of <150 mg/dL (<1.69 mmol/L) at Month 10 and Month 12 Compared to Placebo measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo measure: Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment measure: Incidence Rates of Impaired Glucose Tolerance Throughout the Course of Treatment measure: Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment measure: Change from Baseline in Hemoglobin A1c (HbA1c) During the Treatment Period Compared to Placebo measure: Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo measure: Change from Baseline in C-peptide During the Treatment Period Compared to Placebo measure: Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo measure: Incidence Rates of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) Associated with Worsening Glycemic Control During the Treatment Period Compared to Placebo measure: Initiation of New Medication for Hyperglycemia Among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo measure: Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo measure: Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12 measure: Titers of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06346990 id: Faculty 2023-2024-2-2 briefTitle: The Effect of Listening to Holy Quran Recital on the Incidence of Delirium Post-CABG overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-14 date: 2025-05-15 date: 2024-04-04 date: 2024-04-05 name: Applied Science Private University class: OTHER briefSummary: This study is planned to check the effect of holy Quran recital on the development of delirium after conronary artery bypass graft surgery (CABG). Different studies have been done before about the effects of non-pharmacological intervention on delirium after CABG, howvere, none was designed specifically to check the effect of Holy Qoyran on this outcome. conditions: Coronary Artery Disease conditions: Coronary Artery Bypass Graft Surgery conditions: Delirium, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are two groups in this study. The intervention group and the control group. For the control group, patients are receiving routine care . For the intervention group, after patients were (1) extubated, (2) hemodynamically stable, and (3) negatively rated on primary CAM-ICU, they receive holy Quran recital for four days. Typically, the second, third, fourth- and fifth-days following CABG. The daily sessions were done at 2 PM and 8 PM for 20 minutes each. We choose these times based on the nurses' recommendations about the minimal interruptions from physician rounds and family visits. The selection of Surah Al-Rahman was based on the widespread belief that it is among the most melodic and calming passages in the Quran, especially when recited by the well-known reciter Qari AbdulBasit. 1,5,40 The listening was done using one-use headphones on an iPad. The intervention was discontinued if the participant developed delirium primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Taking into consideration that this was a RCT, blinding the participants was not possible. However, data collectors and data analyzer were blinded. Directly after the intervention, each day at 3pm and 9 pm, the participants were evaluated for development of delirium by the Research assistant how do not know in which group was the participant allocated, and if the result was positive the intervention was discontinued. whoMasked: OUTCOMES_ASSESSOR count: 264 type: ESTIMATED name: Holy Quran Recital measure: Delirium measure: Length of stay-ICU measure: Length of stay-hospital sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06346977 id: DTO-20231214 briefTitle: Diagnosis of Leptomeningeal Metastasis and the Monitoring of Intrathecal Chemotherapy Efficacy in NSCLC overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-04 date: 2024-04-04 name: Wuhan Union Hospital, China class: OTHER briefSummary: Non-small cell lung cancer (NSCLC), occupying a disquieting position as the second most prevalent and deadliest neoplasm worldwide, afflicts an estimated 30% of its patients with intracranial metastatic spread. Among these, leptomeningeal metastasis (LM) is an exceptionally surreptitious and perilous manifestation, often evading timely and accurate diagnosis. The clinical landscape is further complicated by the presence of patients who, due to various reasons, are unable to undergo lumbar puncture, a procedure crucial for the investigation of LM. Moreover, even when cerebrospinal fluid (CSF) analysis via conventional cytological and immunohistochemical methods is attempted, a definitive diagnosis of LM may remain elusive in a subset of cases.
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Intrathecal chemotherapy, particularly via the administration of pemetrexed, which has demonstrated both notable efficacy and an acceptable safety profile when delivered directly into the cerebrospinal space, constitutes a cornerstone of treatment for NSCLC-LM. Despite its importance, the lack of robust, validated biomarkers to gauge the therapeutic response to such interventions represents a significant knowledge gap. This deficit is compounded by the inherent challenges associated with CSF samples, including their limited availability and the suboptimal sensitivity and high resource demands of current ctDNA assessment techniques.
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To address these pressing diagnostic and monitoring needs in NSCLC-LM management, the investigator proposes a forward-looking, non-interventional clinical study harnessing the power of cutting-edge proteomic technologies. These platforms, characterized by their high throughput, exquisite sensitivity, and minimal sample volume requirements, offer a promising avenue for elucidating the intricacies of chemotherapy response in intrathecal therapy. The study aims to provide valuable insights into improving diagnostic accuracy for LM in NSCLC patients and to establish a more rigorous framework for assessing treatment efficacy in individuals undergoing intrathecal chemotherapy, ultimately contributing to enhanced patient care and personalized therapeutic strategies. conditions: Diagnosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Pemetrexed measure: Progression-free survival (PFS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Union hospital city: Wuhan state: Hubei zip: 430000 country: China lat: 30.58333 lon: 114.26667 hasResults: False
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<|newrecord|> nctId: NCT06346964 id: 2024-341 briefTitle: Self-Care Management in Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2025-04-22 date: 2025-06-30 date: 2024-04-04 date: 2024-04-04 name: Ankara Yildirim Beyazıt University class: OTHER briefSummary: Self-management of chronic diseases requires the ability to manage the symptoms, treatment, and lifestyle changes inherent in living with a chronic disease. Rational drug use by older adults is of particular importance. Mobile applications are being developed to facilitate the compliance of older adults with chronic diseases with medication treatment and to increase their disease self-management skills. The research was planned to strengthen participation in social life through rational drug use and disease self-care management in older adults with chronic diseases. The research will be conducted in a parallel group randomized controlled manner. In the research, a mobile application will be developed for the use of older adults. Older adults will be asked to use the mobile application for at least 6 months, and the scales will be re-administered face to face or online in the 3rd and 6th months of the intervention. conditions: Disease Self Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 72 type: ESTIMATED name: mobile application measure: Participation in social life (Social Inclusion Scale) measure: Participation in social life (Social Inclusion Scale) measure: Participation in social life (Social Inclusion Scale) sex: ALL minimumAge: 60 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Yıldırım Beyazıt University city: Ankara state: Çubuk/Turkey zip: 06760 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06346951 id: LPan briefTitle: Survey on the Current Status of IFD Diagnosis and Treatment by Intensive Care Physicians in Sichuan Province (IFS) acronym: IFS overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-09-30 date: 2024-09-30 date: 2024-04-04 date: 2024-04-04 name: Sichuan Provincial People's Hospital class: OTHER briefSummary: The goal of this survey is to learn about the current status of the diagnosis and treatment of invasive fungal infections among intensive care physicians in Sichuan Province (IFS). Its primary focus lies on answering the following questions: ①awareness and proficiency in diagnosis and treatment; ②the use of antifungal medications; ③the application of microbiological identification and diagnostic methods. We aim to analyze the problems and deficiencies that existed among intensive care physicians in order to provide a basis for the development of targeted training and intervention measures. conditions: Invasive Fungal Infections studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: The survey on the hospital's diagnostic and treatment standards and infrastructure for invasive fungal infections measure: The survey on the awareness of an invasive fungal infection among intensive care physicians sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06346938 id: 2024WHXH001 briefTitle: The Clinical Significance of CT-based Biomarkers in the Classification and Prognosis of Bronchiectasis overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2027-03-26 date: 2027-03-26 date: 2024-04-04 date: 2024-04-04 name: Wuhan Union Hospital, China class: OTHER briefSummary: As the third major chronic airway disease in China, bronchiectasis has a wide range of patients. However, the involved sites, morphological features and airway obstruction of bronchiectasis are varied, and clinical heterogeneity is high, making prognosis and severity difficult to evaluate. CT plays an important role in the diagnosis and classification of ramadasis. Based on this, we analyzed the CT findings of patients with bronchiectasis and followed up patients with bronchiectasis to understand their disease progression and prognosis, so as to further analyze the role of CT biomarkers in the type and prognosis of bronchiectasis diseases. conditions: Bronchiectasis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: Frequency of acute exacerbations of bronchiectasis measure: Deterioration of lung function measure: Severity of dyspnoea measure: Degree of emphysema measure: Mucus plug score 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
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<|newrecord|> nctId: NCT06346925 id: SHR8735-116 briefTitle: Study of the Food Effects of Herombopag Olamine Tablets in Healthy Subjects. overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2024-07 date: 2024-04-04 date: 2024-04-04 name: Jiangsu HengRui Medicine Co., Ltd. class: INDUSTRY briefSummary: This study was designed as a single-center, randomized, open, two-cycle, cross-over trial. It is planned to enroll 18 healthy subjects conditions: Adult Patients With Chronic Primary ITP conditions: Adult Patients With SAA Who do Not Respond Well to Immunosuppressive Therapy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Herombopag Olamine Tablets measure: Cmax measure: AUC0-t measure: AUC0-∞ measure: Tmax measure: t1/2 measure: CL/F measure: V/F measure: Incidence and severity of adverse events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: The Second Hospital of Anhui Medical Uniersity city: Hefei state: Anhui zip: 230601 country: China name: Wei Hu role: PRINCIPAL_INVESTIGATOR lat: 31.86389 lon: 117.28083 hasResults: False
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<|newrecord|> nctId: NCT06346912 id: TXB2023022 briefTitle: CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed / Refractory B-cell ALL and B-cell NHL overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-04-15 date: 2027-04-15 date: 2024-04-04 date: 2024-04-04 name: Zhejiang University class: OTHER name: Shanghai YaKe Biotechnology Ltd. briefSummary: Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for refractory/relapsed B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma. conditions: Acute Lymphoblastic Leukemia,B-Cell conditions: Non-hodgkin Lymphoma,B Cell studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: CD19-BAFF Targeted CAR T-cells measure: Dose-limiting toxicity (DLT) measure: Incidence of treatment-emergent adverse events (TEAEs) measure: Overall response rate ,ORR measure: Duration of remission ,DOR measure: Event-free survival, EFS measure: Overall survival, OS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The first affiliated hospital of medical college of zhejiang university city: Hangzhou state: Zhejiang zip: 310000 country: China name: He Huang, MD role: CONTACT phone: 86-13605714822 email: [email protected] name: Yongxian Hu, MD role: CONTACT phone: +8615957162012 email: [email protected] lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06346899 id: TAK-743-4012 briefTitle: A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in China overallStatus: NOT_YET_RECRUITING date: 2024-08-14 date: 2025-08-13 date: 2025-08-13 date: 2024-04-04 date: 2024-04-04 name: Takeda class: INDUSTRY briefSummary: The Chinese health authority has approved lanadelumab to prevent Hereditary Angioedema (HAE) attacks in persons of 12 years and older. It has also approved icatibant to treat acute HAE attacks in persons 2 years and older.
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One of the main aims of this study is to learn about the number of HAE attacks in 1 month in Chinese persons with HAE during their treatment with lanadelumab. The other main aim is to learn how much time is needed to resolve acute HAE attacks when treated with icatibant. Other aims of this study are to learn more about side effects of lanadelumab and icatibant treatment as well as to collect additional information on the treatment with lanadelumab, such as the dose and how often it needs to be given, reasons for stopping the treatment with lanadelumab and how long it was taken until stopping. Participants will be treated by their doctors according to routine medical practice. Only data already available in the medical records of the participants will be reviewed and collected during this study. conditions: Hereditary Angioedema (HAE) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 130 type: ESTIMATED name: No intervention measure: Monthly Rate of HAE Attacks for Each Lanadelumab-treated Participant During the Lanadelumab Exposure Period measure: Median Time to Complete Attack Resolution for Icatibant Treated Participants measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) During Lanadelumab and Icatibant Exposure Period measure: Dosage of Lanadelumab Among Lanadelumab-treated Participant During the Lanadelumab Exposure Period measure: Frequency Administration of Lanadelumab Among Lanadelumab-treated Participant During the Lanadelumab Exposure Period measure: Number of Participants with Reasons of Discontinuation of Lanadelumab During the Lanadelumab Exposure Period measure: Time to Lanadelumab Discontinuation Among Lanadelumab-treated Participant During the Lanadelumab Exposure Period sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06346886 id: 23-011703 briefTitle: HTN App for HTN Control and Cardiovascular Health Among African-Americans overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-07 date: 2025-07 date: 2024-04-04 date: 2024-04-04 name: Mayo Clinic class: OTHER name: Miami Heart Research Institute Inc. briefSummary: The purpose of this study is to test the hypertension (HTN) app-based intervention to see if it is more effective in improving uncontrolled HTN and HTN self-care among Africian-Americans from baseline to post-intervention (immediate, 3 months and 6 months post-intervention) as compared to the standard of care. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: FAITH! HTN app measure: Absolute Change in Systolic Blood Pressure (BP) measure: HTN Self-Care as reported by H-SCALE(HTN Self-Care Activity Level Effects) measure: Proportion of subjects reaching BP control measure: Change in BP as assessed by home BP cuff measurements measure: CV Health Knowledge as measured by module assessment scores measure: Hypertension (HTN) Knowledge as assessed by 11-item questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States name: Lainey Moen role: CONTACT phone: 507-266-7062 email: [email protected] name: Ashton Krogman role: CONTACT phone: (507) 266-2087 email: [email protected] name: LaPrincess Brewer, M.D., M.P.H. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False
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<|newrecord|> nctId: NCT06346873 id: 23-008090 briefTitle: Demonstrating Efficacy of JOGO for the Treatment of Tremor overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-09 date: 2027-09 date: 2024-04-04 date: 2024-04-04 name: Mayo Clinic class: OTHER briefSummary: This research is being done to determine the effectiveness of a new treatment, called JOGO, for patients with functional tremor (FT). JOGO is a biofeedback device that has been shown to help patients with several conditions, e.g., chronic pain, migraine, and Parkinson's disease (PD)-related tremor. JOGO provides biofeedback by using wireless adhesive stickers, called surface electromyography, to get information about muscle activity. This information is then used to modify symptoms through a series of training sessions with a physical therapist and individual practice. conditions: Functional Neurological Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: JOGO measure: Change in TETRAS scores 1 month measure: Change in TETRAS scores 2 months measure: Change in QUEST scores measure: Tremor prevalence measure: Tremor resolution 1 month measure: Tremor resolution 2 months measure: Change in BDI-II scores measure: Change in BAI scores measure: Change in Intolerance of Uncertainty Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Florida city: Jacksonville state: Florida zip: 32224 country: United States lat: 30.33218 lon: -81.65565 hasResults: False
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<|newrecord|> nctId: NCT06346860 id: 09.2024.241 briefTitle: Comparing Intrathecal Morphine With Modified Thoracoabdominal Nerve Block Through Perichondral Approach in Major Abdominal Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-04 date: 2024-04-19 name: Marmara University class: OTHER briefSummary: Abdominal surgery causes severe postoperative pain due to retraction of the abdominal wall and direct manipulation of visceral organs. It leads to delayed postoperative recovery, increased postoperative morbidity and mortality. Intrathecal morphine, epidural analgesia and patient-controlled intravenous analgesia are used in postoperative pain management of abdominal surgeries. Intrathecal morphine is frequently used in many centers because it provides effective pain control. However; morphine has undesirable effects such as urinary retention, postoperative nausea and vomiting, and respiratory depression. Modified thoracoabdominal nerves block through perichondrial approach is a technique defined by the modification of the thoracoabdominal nerves block through perichondrial approach, in which local anesthetics are delivered only to the underside of the perichondral surface. The primary implication of this study is to compare postoperative pain scores and opioid consumption in patients undergoing major abdominal surgery with intrathecal morphine or modified thoracoabdominal nerves block through perichondrial approach. conditions: Opioid Use conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 56 type: ESTIMATED name: Regional Block Comparison measure: Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device measure: Postoperative pain assessment with Numeric Rating Scale (NRS) measure: Comparison of the frequency of treatment related complications measure: Participant satisfaction sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marmara University School of Medicine city: Istanbul country: Turkey name: Beliz Bilgili role: CONTACT phone: 05362187927 email: [email protected] name: Ayse Deniz Kayir role: CONTACT phone: 05465626316 email: [email protected] lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06346847 id: TAC/231001/AKM/IBS id: IBS-D PAM type: OTHER domain: The Akkermansia Company briefTitle: Study to Assess Effects of Pasteurized Akkermansia Muciniphila vs Placebo in Participants With Diarrhea-predominant IBS acronym: PAM-DIGEST overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-05-01 date: 2024-04-04 date: 2024-04-04 name: A-Mansia Biotech S.A. class: INDUSTRY name: Vedic Lifesciences Pvt. Ltd. briefSummary: The present study is a randomized, double-blind, placebo-controlled, parallel group clinical study that assesses the effect of pasteurized Akkermansia muciniphila on the complaints of subjects with moderate to severe diarrhoea-predominant irritable bowel syndrome (IBS-D). The trial is also evaluating the potential of pAkk on anxiety, low mood and stress of the participants, as well as its safety and tolerability.
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The intervention duration for all the study participants is 12 weeks (intervention phase). Subsequently, the participants will be invited to return to site for an end of study assessment after 21 days of no intervention (post-intervention phase). conditions: Diarrhea-Predominant Irritable Bowel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, Double-blind, Placebo-controlled primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 380 type: ESTIMATED name: Pasteurized Akkermansia muciniphila (pAKK) name: Placebo measure: To assess the impact of Investigational Product relative to placebo on percentage responders in terms of improvement of the IBS-Symptom Severity Scores (SSS) in participants with moderate to severe diarrhea-predominant irritable bowel syndrome. measure: To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the IBS-SSS from baseline at week 8 measure: To assess the impact of the Investigational Product in comparison to placebo on mean change in Generalized Anxiety Disorder (GAD)-7 score measure: To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the GAD-7 from baseline at week 12. measure: To assess the impact of the Investigational Product in comparison to placebo on mean change in Patient Health Questionnaire (PHQ)-9 score measure: To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the PHQ-9 from baseline at week 12. measure: To assess the impact of the Investigational Product in comparison to placebo on mean change in Perceived Stress Scale (PSS) measure: To assess the impact of the Investigational Product in comparison to placebo on mean change in Bristol Stool Form Score (BSFS) measure: To assess the impact of the Investigational Product in comparison to placebo on occurrence of normal BSFS score at the end of the study measure: To assess the impact of the Investigational Product in comparison to placebo on the quality of life as assessed by the mean change in IBS-QOL scores measure: To assess the impact of the Investigational Product in comparison to placebo on mean change in IBS-SSS value measure: To assess the impact of the Investigational Product in comparison to placebo on compliance with the intake of the investigational product measure: To assess the impact of the Investigational Product in comparison to placebo on Safety and tolerance measure: To assess the impact of the Investigational Product in comparison to placebo on the impact of IBS on their quality of life using the IBS-Quality of Life (IBS-QoL) instrument. sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: HCG Hospital city: Ahmedabad state: Gujarat zip: 380006 country: India name: Dr. Manoj Vithalani, MBBS, MD role: CONTACT phone: 9825024355 email: [email protected] name: Dr. Manoj Vithalani, MBBS, MD role: PRINCIPAL_INVESTIGATOR lat: 23.02579 lon: 72.58727 facility: Anand Multispeciality Hospital city: Vadodara state: Gujarat zip: 390016 country: India name: Dr. Himanshu Patel, MBBS, DNB role: CONTACT phone: 8141001672 email: [email protected] name: Dr. Himanshu Patel, MBBS, DNB role: PRINCIPAL_INVESTIGATOR lat: 22.29941 lon: 73.20812 facility: Stress Test Clinic city: Mumbai state: Maharashtra zip: 400059 country: India name: Dr. Ramesh Dargad, MBBS, MD role: CONTACT phone: 9820152828 email: [email protected] name: Dr. Ramesh Dargad, MBBS, MD role: PRINCIPAL_INVESTIGATOR lat: 19.07283 lon: 72.88261 facility: Criticare Asia Multispeciality Hospital & Research Centre city: Mumbai state: Maharashtra zip: 400069 country: India name: Dr. Sanjeev Khanna, MD, MNAMS role: CONTACT phone: 9820055090 email: [email protected] name: Dr. Sanjeev Khanna, MD, MNAMS role: PRINCIPAL_INVESTIGATOR lat: 19.07283 lon: 72.88261 facility: Surya Multispeciality Hospital city: Nashik state: Maharashtra zip: 422003 country: India name: Dr. Gaurav Bachhav, MD, DM role: CONTACT phone: 9867111119 email: [email protected] name: Dr. Gaurav Bachhav, MD, DM role: PRINCIPAL_INVESTIGATOR lat: 19.99727 lon: 73.79096 facility: Astha Clinic city: Nashik state: Maharashtra zip: 422011 country: India name: Dr. Mohit Chaudhary, MBBS, MD role: CONTACT phone: 7744825746 email: [email protected] name: Dr. Mohit Chaudhary, MBBS, MD role: PRINCIPAL_INVESTIGATOR lat: 19.99727 lon: 73.79096 facility: Apollo Hospital city: Navi Mumbai state: Maharashtra zip: 400614 country: India name: Dr. Amey Sonavane, MBBS, DNB role: CONTACT phone: 9619879955 email: [email protected] name: Dr. Amey Sonavane, MBBS, DNB role: PRINCIPAL_INVESTIGATOR lat: 19.03681 lon: 73.01582 facility: Swara Hospital city: Palghar state: Maharashtra zip: 401303 country: India name: Dr. Prashant Walke, MBBS, MD role: CONTACT phone: 9860844434 email: [email protected] name: Dr. Prashant Walke, MBBS, MD role: PRINCIPAL_INVESTIGATOR lat: 19.69693 lon: 72.76543 facility: Gastrohub Hospital city: Pune state: Maharashtra zip: 411027 country: India name: Dr. Mandar Doiphode, MBBS, DNB role: CONTACT phone: 9850077168 email: [email protected] name: Dr. Mandar Doiphode, MBBS, DNB role: PRINCIPAL_INVESTIGATOR lat: 18.51957 lon: 73.85535 facility: Umarji Mother and Child Care Hospital city: Pune state: Maharashtra zip: 411045 country: India name: Dr. Prasad Bhatte, MD DM role: CONTACT phone: 9920039265 email: [email protected] name: Dr. Prasad Bhatte, MD DM role: PRINCIPAL_INVESTIGATOR lat: 18.51957 lon: 73.85535 facility: Lifeline Multispeciality Hospita city: Pune state: Maharashtra zip: 412101 country: India name: Dr. Shrikant Kote, MBBS, MD role: CONTACT phone: 7506360679 email: [email protected] name: Dr. Shrikant Kote, MBBS, MD role: PRINCIPAL_INVESTIGATOR lat: 18.51957 lon: 73.85535 facility: Asian Institute of Medical sciences city: Thāne state: Maharashtra zip: 421203 country: India name: Dr Vineet Chaudhari, MD, DNB role: CONTACT phone: 7337422597 email: [email protected] name: Dr Vineet Chaudhari role: PRINCIPAL_INVESTIGATOR lat: 19.19704 lon: 72.96355 facility: Maharaja Agrasen Superspeciality Hospital city: Jaipur state: Rajasthan zip: 302039 country: India name: Dr. Prabhat K Sharma, MBBS, MD role: CONTACT phone: 9983995050 email: [email protected] name: Dr. Prabhat K Sharma, MBBS, MD role: PRINCIPAL_INVESTIGATOR lat: 26.91962 lon: 75.78781 facility: Samvedna Hospita city: Varanasi state: Uttar Pradesh zip: 221005 country: India name: Dr. Hemant K Gupta, MBBS, MD, DM role: CONTACT phone: 8573888800 email: [email protected] name: Dr. Hemant K Gupta, MBBS, MD, DM role: PRINCIPAL_INVESTIGATOR lat: 25.31668 lon: 83.01041 hasResults: False
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<|newrecord|> nctId: NCT06346834 id: PRO-sIPV-4002 briefTitle: Sequential Vaccination of Poliomyelitis Vaccine (Vero Cells), Inactivated, Sabin Strains From Different Manufacturers overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-08-31 date: 2024-12-30 date: 2024-04-04 date: 2024-04-15 name: Sinovac Biotech Co., Ltd class: INDUSTRY briefSummary: To evaluate the immunogenicity and safety of sequential vaccination with Sinovac sIPV among infants who have received two doses of Biological Products Co., Ltd. sIPV. conditions: Poliomyelitis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: sIPV measure: Geometric Mean Increase (GMI) measure: Geometric Mean Titer (GMT) measure: Seropositivity rate measure: Seroconversion rate measure: Adverse reaction incidence measure: Serious adverse events incidence sex: ALL maximumAge: 12 Months stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06346821 id: WestChinaGBMTTFieldsV1.0 briefTitle: Tumor Treating Fields for Newly Diagnosed Glioblastoma: Two Emulated Trials With Chinese Multi-Hospital Based Real-World Data overallStatus: RECRUITING date: 2023-07-04 date: 2024-04-01 date: 2024-05-01 date: 2024-04-04 date: 2024-04-04 name: Sichuan University class: OTHER briefSummary: The goal of this observational study is to learn about the effectiveness of Optune® (Tumor Treating Fields) in newly diagnosed glioblastoma (GBM) in China. The main question it aims to answer are:
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* The efficacy of Optune® as an concomitant/adjuvant to radiation therapy (RT) and temozolomide (TMZ) alone in the treatment of newly diagnosed GBM patients.
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* The effectiveness of Optune® given concomitantly with RT and TMZ in newly diagnosed GBM patients, compared to RT and TMZ alone.
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Participants will:
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* Receive or not receive TTFields.
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* Concomitantly or adjuvantly receive TTFields. conditions: Glioblastoma Multiforme studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED name: Optune® (Tumor Treating Fields) measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital status: RECRUITING city: Chengdu state: Sichuan zip: 610041 country: China name: Lei Liu, PhD, MD role: CONTACT phone: +8618980606231 email: [email protected] lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06346808 id: PDAC-OV briefTitle: Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With BRPC/LAPC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2027-05-01 date: 2024-04-04 date: 2024-04-04 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 Oncolytic virus Plus Anti-PD1 and Chemotherapy as Preoperative therapy for Patients with Borderline Resectable and Locally Advanced Pancreatic Cancer conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Oncolytic virus Plus Anti-PD1 and Chemotherapy measure: Incidence of Treatment-Related Adverse Events [Safety and Tolerability] measure: R0 resection rate measure: ORR sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital, Sichuan University city: Chengdu state: Sichuan zip: 610000 country: China name: Zhong Wu, MD role: CONTACT lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06346795 id: SelcukC briefTitle: Class II Restorations With High-Filled Flowable Composites overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-01 date: 2025-06-01 date: 2024-04-04 date: 2024-04-25 name: Selcuk University class: OTHER briefSummary: In the study, Class II restorations will be performed with G-aenial Universal Injectable (GC/ Tokyo, Japan), Grandio Flow (VOCO/ Germany), and Clearfil Majesty Flow (Kuraray/ Japan) composites will evaluated. Restorations will be assessed according to modified USPHS criteria in 1st week, 6th months, and 12th months from the placement date. The Chi-square test will used for statistical analysis of the difference between the groups, and the Cochran Q test will used for the significance of the difference between time-dependent changes within each group (p\<0.05). conditions: Dental Caries conditions: Class II Dental Caries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: High-filling flowable dental composite measure: Retention measure: Color match measure: Marginal discoloration measure: Marginal adaptation measure: Secondary caries measure: Surface texture measure: Anatomical form measure: Postoperative sensitivity sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Selcuk University, Faculty of Dentistry, Restorative Dentistry Department city: Konya country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
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<|newrecord|> nctId: NCT06346782 id: IRB00370545 briefTitle: Feasibility and Acceptability of Internet-based Parent-child Interaction Therapy (I-PCIT) in Pediatric Cancer acronym: I-PCIT overallStatus: RECRUITING date: 2024-02-19 date: 2028-08-01 date: 2028-08-01 date: 2024-04-04 date: 2024-04-04 name: Johns Hopkins All Children's Hospital class: OTHER briefSummary: This study is being done to learn whether a telehealth intervention called "Internet-Based Parent Child Interaction Therapy," or I-PCIT," can help parents improve the child's behavior if the child currently or previously went through cancer treatment.
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Parents who choose to be in this study will complete a survey to help researchers figure out if the parent is eligible for the larger study. If a parent is eligible for the larger study and chooses to participate, if so, the participants will be randomly assigned to either receive the I-PCIT intervention now or to be on a waitlist and begin I-PCIT in 5-6 months. The whole study consists of completing I-PCIT sessions with a clinician and completing 3-4 follow-up surveys after the initial screener survey. conditions: Pediatric Cancer conditions: Oncology conditions: Disruptive Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a pilot feasibility trial. We are using a 2:1 (intervention: waitlist control) randomized controlled design. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 300 type: ESTIMATED name: Internet-Based Parent-Child Interaction Therapy measure: I-PCIT Feasibility as assessed by intervention completion measure: I-PCIT Acceptability as assessed by the Treatment Evaluation Inventory Short form sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins All Children's Hospital status: RECRUITING city: Saint Petersburg state: Florida zip: 33701 country: United States name: Melissa Faith, Ph.D. role: CONTACT phone: 727-295-8477 email: [email protected] lat: 27.77086 lon: -82.67927 hasResults: False
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<|newrecord|> nctId: NCT06346769 id: SelcukB briefTitle: Composite Restorations Performed by Placing Polyethylene Fiber overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2024-10-15 date: 2025-04-15 date: 2024-04-04 date: 2024-04-04 name: Selcuk University class: OTHER briefSummary: This study aimed to evaluate the 12-month clinical performance of direct composite restorations by placing polyethylene fibers in different directions in endodontically treated posterior teeth. In this clinical study, Clearfil SE Bond (Kuraray/Japan) adhesive system, G-aenial Universal Injectable (GC/Tokyo, Japan), G-aenial A'chord (GC/Tokyo, Japan) composites, and polyethylene fiber (Ribbond, USA) were used. In the restoration of the teeth included in the study, polyethylene fiber was placed in different directions according to the amount of remaining tooth tissue and cavity preparation. The restorations were divided into three groups according to the direction of fiber placement ('O' shape, mesiodistal I shape, buccolingual I shape) (n=12). Restorations were evaluated according to modified USPHS criteria in 1st week and 6th months from the placement date. The Chi-square test was used for statistical analysis of the difference between the groups, and the Cochran Q test was used for the significance of the difference between time-dependent changes within each group (p\<0.05). conditions: Endodontically Treated Teeth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 68 type: ACTUAL name: Polyethylene Fiber measure: Retention measure: Color match measure: Marginal Discoloration measure: Marginal adaptation measure: Secondary caries measure: Surface texture measure: Anatomical form sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Selcuk University, Faculty of Dentistry, Restorative Dentistry Department city: Konya country: Turkey lat: 37.87135 lon: 32.48464 facility: Selcuk University, Faculty of Dentistry city: Konya country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
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<|newrecord|> nctId: NCT06346756 id: SelcukA briefTitle: Clinical Evaluation of Class II Restorations overallStatus: COMPLETED date: 2023-01-01 date: 2023-07-01 date: 2023-07-15 date: 2024-04-04 date: 2024-04-04 name: Selcuk University class: OTHER briefSummary: This study aims to evaluate the one-year clinical performance of Class II restorations made with high-filling injectable and condensable universal composite resins.
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The study included 62 patients and 147 restorations. It used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), Filtek Ultimate (FU) composites, and the Clearfil SE Bond adhesive system. GCI only in premolar teeth; GCA, TP, and FU have been used to restore premolar and molar teeth. Restorations were evaluated and scored according to modified USPHS criteria at seven days, six months, and one year. Chi-square and Cochran Q tests were used for statistical analysis (p\<0.05). conditions: Dental Caries conditions: Dental Caries Class II studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 62 type: ACTUAL name: Treatment of dental caries. measure: Retention measure: color match measure: marginal adaptation measure: marginal discoloration measure: surface texture measure: anatomical form measure: secondary caries measure: postoperative sensitivity sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Selcuk University, Faculty of Dentistry city: Konya country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
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<|newrecord|> nctId: NCT06346743 id: IRB/2023/1119/SIMS briefTitle: Comparison of Effects of Fenofibrate Adjuvant Therapy Versus Conventional Phototherapy in Neonatal Jaundice. overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2024-08 date: 2024-04-04 date: 2024-04-04 name: Muhammad Zark class: OTHER_GOV briefSummary: Neonatal jaundice has significant importance in neonatal morbidity and mortality world-wide. Though phototherapy has a relentless use in neonatal jaundice, its cumbersome side effects and the physical separation of baby from the mother eventually result as increase in days of hospitalization adding to the mental anguish of the parents. This study is conducted to observe the reduction of serum bilirubin level in neonates treated with Fenofibrate as an adjuvant to phototherapy in treatment of exaggerated physiological hyperbilirubinemia. After informed consent, single dose of Fenofibrate will be given to the group A (intervention group) and Group B (non-intervention) will only be given phototherapy. Then every 24-hourly sample for serum bilirubin will be sent for lab analysis, for 3 days. A randomized control trial is conducted and later on, the data will be analyzed in the SPSS 26. Quantitative variables like age will be presented as mean ± SD. Qualitative variables like gender will be presented as percentage and frequency. Comparison of two groups intervention group and non-intervention group, apply independent sample t-test. P value \< 0.05 will be taken as significant. Limitation of the proposed study includes limited sample size, study population limited to only one hospital and no follow-up in plan. If the role of Fenofibrate is established in the management of exaggerated physiological hyperbilirubinemia in newborns, it will be beneficial to minimize the risk of the complications, rapid regression of hyperbilirubinemia \& shortening the length of hospital stay. conditions: Physiological Neonatal Jaundice conditions: Physiological Hyperbilirubinaemia studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: To compare the effects of Fenofibrate adjuvant to phototherapy with conventional phototherapy for exaggerated neonatal hyperbilirubinemia in the form of bilirubin reduction, duration of phototherapy, hospital stay \& observation of side-effects.
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After informed consent, single dose of Fenofibrate will be given to the group A (intervention group) and Group B (non-intervention) will only be given phototherapy. Then every 24-hourly sample for serum bilirubin will be sent for lab analysis, for 3 days. A randomized control trial is conducted. primaryPurpose: TREATMENT masking: NONE count: 156 type: ESTIMATED name: Fenofibrate name: Phototherapy measure: number of days needed for serum bilirubin to decrease below phototherapy range measure: Hospital length of Stay sex: ALL minimumAge: 24 Hours maximumAge: 14 Days stdAges: CHILD facility: Services Institute of Medical Sciences city: Lahore state: Punjab zip: 54000 country: Pakistan name: Noman Abdullah role: CONTACT phone: +923124100143 email: [email protected] name: Muhammad Zark, MBBS role: PRINCIPAL_INVESTIGATOR lat: 31.558 lon: 74.35071 hasResults: False
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<|newrecord|> nctId: NCT06346730 id: 142-18 briefTitle: The Effect of Virtual Reality Application on Anxiety and Patient Satisfaction During Intrauterine Insemination (IUI) acronym: (IUI) overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-08-30 date: 2024-09-30 date: 2024-04-04 date: 2024-04-09 name: Suleyman Demirel University class: OTHER briefSummary: This study will conduct as a randomized pretest-posttest study to examine the effect of virtual reality glasses (VRG) application during the IUI procedure on anxiety and patient satisfaction. The population of the research will consist of women who were treated with assisted reproductive techniques and underwent IUI at the infertility polyclinic of Ministry of Health Adana City Training and Research Hospital between May and December 2024 and who meet the research criteria. The research sample was calculated as a total of 90 people (at least 45 people in each group) using the power program. Data; Personal Information Form, Visual Assessment Scale (VAS), State Trait Anxiety Inventory (STAI) and Patient's Perception of Nursing Care Scale will be collected from women who agree to participate in the research. Virtual reality glasses will be applied to the intervention group. conditions: Virtual Reality conditions: Anxiety conditions: Patient Satisfaction conditions: Intrauterine Insemination (IUI) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The sample will divide into intervention and control groups primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 90 type: ESTIMATED name: Virtual reality glasses to intervention group measure: State Trait Anxiety Inventory (STAI) measure: Patient's Perception of Nursing Care Scale sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06346717 id: SINOPU-elif 2 briefTitle: Mobile Application Based Care for Total Knee Prosthesis Patients acronym: KneeMobilApp overallStatus: RECRUITING date: 2024-03-27 date: 2025-03-30 date: 2025-03-30 date: 2024-04-04 date: 2024-04-04 name: Sinop University class: OTHER briefSummary: Total knee prosthesis (TKP); It is a surgical treatment used in the management of functional limitations and severe pain occurring on the degenerated joint surface as a result of rheumatoid arthritis, osteoarthritis, posttraumatic arthritis and other nonspecific arthritis. Nursing care is of great importance in the success of TKP surgery. Reducing pain, preventing complications, increasing self-care ability, and improving the quality of life by improving postoperative knee functions are the main goals of postoperative nursing care. In order to achieve these goals, patients and their relatives need to receive training on home care in the post-operative period before discharge. With the increasing use of mobile technologies in daily life and the increasing adoption of e-health, the opportunity for people to improve their self-management skills through e-health is increasing. Mobile Health (m-Health) provides convenience in many areas such as educating the public, warning about potential diseases and disease risks, and communicating with messages, notifications and video when necessary. It also affects the way nursing services are delivered and provides great benefits in the delivery of nursing services. For all these reasons, it was aimed to examine the effect of mobile application-supported care given to patients with total knee prosthesis on functional status and self-care ability. conditions: Knee Prosthesis conditions: Mobile Application studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: "Knee Prosthesis-M" mobile application service measure: Knee Injury and Osteoarthritis Outcome Score = KOOS measure: Exercise of Self-Care Agency=ESCA sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Elif ALTINKAYNAK SARAL status: RECRUITING city: Merkez state: Osmaniye Köyü zip: 5700 country: Turkey name: ELİF ALTINKAYNAK SARAL, PhD role: CONTACT phone: 05436071986 email: [email protected] name: Sonay GÖKTAŞ, PhD role: CONTACT phone: 05324567776 email: [email protected] hasResults: False
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<|newrecord|> nctId: NCT06346704 id: PR5030-66 briefTitle: Prospective Longitudinal Monocentric Study to Evaluate the Syde® Digital Endpoint in Patients With Multiple Sclerosis acronym: NHS-MS-EGYPT overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2026-11-30 date: 2026-11-30 date: 2024-04-04 date: 2024-04-04 name: SYSNAV class: INDUSTRY briefSummary: The study aims to assess the validity of real-world activity monitoring by the Syde® wearable device in subjects with multiple slclerosis. The Syde® collected data will be compared to on-site conventional clinical endpoints for MS pathology (EDSS, FSS and T25FWT). Subjects with multiple sclerosis will be assessed every 6 months for 2 years. conditions: Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Digital HealthTechnology measure: Longitudinal change of 95th centile of stride velocity measure: Correlation of the Syde® variables with the clinical assessments EDSS, FSS and T25FWT sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06346691 id: MTU-EC-IM-0-235/66 briefTitle: Bronchodilator Effect of Oral Doxofylline and Procaterol in Chronic Obstructive Pulmonary Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-16 date: 2024-09-30 date: 2024-12-31 date: 2024-04-04 date: 2024-04-05 name: Thammasat University class: OTHER briefSummary: The goal of this clinical trial is to determine if doxofylline and procaterol are effective in treating patients with stable chronic obstructive pulmonary disease (COPD). It will also assess the safety of both drugs.
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The main questions it aims to answer are:
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* Does doxofylline demonstrate a comparable bronchodilator effect to procaterol in COPD participants?
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* What medical problems do participants experience when taking doxofylline and procaterol?" conditions: COPD studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Crossover randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Doxofylline name: Procaterol measure: Forced expiratory volume in 1 second (FEV1) measure: Forced vital capacity (FVC) measure: Forced expiratory flow at 25-75% of FVC (FEF25-75) measure: modified Medical Research Council (mMRC) score measure: COPD Assessment Test (CAT) sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06346678 id: MTU-EC-IM-0-016/67 briefTitle: Accuracy of Accuhaler Tester, Ellipta Tester and Turbutester in Patients With Chronic Obstructive Pulmonary Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-16 date: 2024-08-31 date: 2024-10-31 date: 2024-04-04 date: 2024-04-04 name: Thammasat University class: OTHER briefSummary: The goal of this observational study is to investigate the accuracy of Accuhaler tester, Ellipta tester and Turbutester in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:
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• Do Accuhaler tester, Ellipta tester, and Turbutester demonstrate comparable accuracy to the In-check DIAL for assessing inspiratory inhalation force in COPD patients? conditions: Chronic Obstructive Pulmonary Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 80 type: ESTIMATED name: Accuhaler tester measure: Accuracy of Accuhaler tester measure: Accuracy of Ellipta tester measure: Accuracy of Turbutester measure: Prevalence of suboptimal peak inspiratory flow rate measure: Prevalence of insufficient peak inspiratory flow rate sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06346665 id: DZIF Tx-Cohort briefTitle: The Transplant Cohort of the German Center for Infection Research overallStatus: RECRUITING date: 2016-01 date: 2025-12 date: 2030-12 date: 2024-04-04 date: 2024-04-23 name: Technical University of Munich class: OTHER name: Hannover Medical School name: University Hospital Heidelberg name: Universität Tübingen name: Klinikum der Universität München name: Max von Pettenkofer-Institut München name: Nierenzentrum Heidelberg name: Helmholtz Centre for Infection Research briefSummary: Medical data and biological samples obtained from transplant patients are collected and managed across Germany with the help of the DZIF Transplant Cohort. The data and samples form the basis of scientific studies which investigate the connections between numerous factors influencing an organ's susceptibility to infection and organ function. conditions: Infections conditions: Transplant Complication conditions: Transplant Failure conditions: Immunosuppression studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED measure: Realisation of studies that focus on the the medical needs of transplant patients, particularly with regard to their susceptibility to infection sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Technische Universität München status: RECRUITING city: München country: Germany name: Daniela Schindle, Dr. role: CONTACT lat: 48.13743 lon: 11.57549 hasResults: False
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<|newrecord|> nctId: NCT06346652 id: REC-UOL-216-03-2024 briefTitle: Effects of Core Strengthening and PNF Pattern on Static Balance and Plantar Pressure in Chronic Stroke Patients overallStatus: RECRUITING date: 2024-03-10 date: 2024-04-22 date: 2024-04-30 date: 2024-04-04 date: 2024-04-04 name: University of Lahore class: OTHER briefSummary: Stroke is a neurological disease characterized by neurological deficits caused by insufficiency of blood supply to brain. Disruption of blood supply to brain can be due to blockage of blood supply (ischemic) or leakage of blood in brain due to rupture of blood vessel (hemorrhagic). 90.5% of global occurrence of stroke was subjected to modifiable risk factors according to Global Burden of Disease study.
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This study aims to compare the effects of core strengthening and proprioceptive neuromuscular facilitation on static standing balance and plantar pressure in chronic stroke patients. conditions: Chronic Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 73 type: ESTIMATED name: Routine Physical Therapy name: Routine Physical Therapy+ PNF and Core Stregthening measure: Static Standing Balance measure: Plantar Pressure sex: ALL minimumAge: 45 Years maximumAge: 60 Years stdAges: ADULT facility: The University of Lahore Teaching Hospital status: RECRUITING city: Lahore zip: 54000 country: Pakistan name: Safa Saleem, MSPTN role: CONTACT phone: 03354028864 email: [email protected] name: Sameed Liaqat, MPhil role: CONTACT phone: 03249004200 email: [email protected] lat: 31.558 lon: 74.35071 hasResults: False
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<|newrecord|> nctId: NCT06346639 id: LithuananianSportsU-17 briefTitle: Effect of a 16-day Hot and Cold Acclimation on Adaptive Responses and Health-related Indicators overallStatus: RECRUITING date: 2024-04-04 date: 2029-04-04 date: 2029-04-04 date: 2024-04-04 date: 2024-04-15 name: Lithuanian Sports University class: OTHER briefSummary: There are no previous studies of the effects of a combination of whole-body immersions in hot and cold baths on adaptive responses and health-related markers. Thus, the primary aim of this project is to determine whether interventions consisting of whole body immersion in hot and cold baths over 16 days develop heat and/or cold adaptation by remodeling thermoregulatory, metabolic, cardiovascular and physiological responses, and the secondary aim is to determine if current cold-hot acclimation has any effects on physical and mental health-related markers. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE maskingDescription: The researchers who will analyze the saliva and venous blood samples will be blinded. count: 31 type: ESTIMATED name: 16-day hot and cold acclimation measure: Change in body mass and body composition (kg) measure: Change in skinfold thickness (mm) measure: Change in body mass index (kg/m^2) measure: Change in body surface area (m^2) measure: Change in substrate oxidation measure: Change in substrate oxidation (g/day) measure: Change in ventilation (l/min) measure: Change in breathing frequency (t/min) measure: Change in resting energy expenditure (kcal/day) measure: Change in metabolic heat production (W) measure: Change in heart rate (bpm) measure: Change in blood pressure (mmHg) measure: Change in mean arterial pressure (mmHg) measure: Change in heart rate variability (ms) measure: Change in heart rate variability (time domain) (ms) measure: Change in heart rate variability (time domain) (Ln) measure: Change in heart rate variability (frequency domain) (ms^2) measure: Change in heart rate variability (frequency domain) (Ln) measure: Change in stroke volume (ml) measure: Change in stroke volume index (ml/m^2) measure: Change in cardiac output index (l/min//m^2) measure: Change in cardiac output index (l/min) measure: Change in contractility index measure: Change in ventricular ejection time (ms) measure: Change in ventricular ejection fraction (percent) measure: Change in end diastolic volume (ml) measure: Change in systemic vascular resistance (dyn.s/cm5.m^2) measure: Change in cardiac work index (kg.m/m^2) measure: Change in early diastolic filling ratio (percent) measure: Change in testosterone concentration (µg/dl) measure: Change in female sex hormones concentration (pg/mL) measure: Change in salivary cortisol concentration (µg/dl) measure: Change in cytokines concentrations (pg/ml) measure: Change in complete blood count (10^9/L) measure: Change in complete blood count (percent) measure: Change in lipid profile (mmol/l) measure: Change in catecholamines concentration (ng/ml) measure: Change in insulin concentration (μIU/ml) measure: Change in glucose tolerance (mmol/l) measure: Change in anxiety and depression (points) measure: Change in plasma metabolites of the kynurenine pathway (μm) measure: Change in body temperature (°C) measure: Change in physiological strain index measure: Change in cold strain index measure: Change in root mean square (RMS) amplitude (mV) measure: Change in pain sensations measure: Change in thermal sensations (points) measure: Change in shivering/sweating (points) measure: Change in thermal comfort (points) measure: Height (m) measure: Change in physical activity (in h) measure: Change in sleep (in h) measure: Change in oxygen saturation (percent) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Lithuanian Sports University status: RECRUITING city: Kaunas zip: LT-44221 country: Lithuania name: Diana Reklaitienė, PhD role: CONTACT lat: 54.90272 lon: 23.90961 hasResults: False
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<|newrecord|> nctId: NCT06346626 id: 2WIN-S2024 briefTitle: To Evaluate the Consistency and Repeatability of Portable Automatic Optometry 2-WINS for Cycloplegic Optometry in Adolescents and Children overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-06-01 date: 2024-04-04 date: 2024-04-04 name: He Eye Hospital class: OTHER briefSummary: Myopia, also known as short-sightedness or near-sightedness, is a prevalent condition that typically emerges during childhood and early adulthood. It occurs when the eye elongates excessively, causing images of distant objects to focus in front of the retina, leading to blurred distance vision. The number of people with myopia is increasing every year, reaching half of the world's population by 2050. The global potential productivity loss due to uncorrected refractive errors was $244 billion in 2015. Due to the strong association between high myopia and pathological changes in the choroid, retina, and sclera, leading to irreversible vision loss, and the fact that correcting the refractive error does not halt the progression of pathology, the prevention of myopia, especially high myopia, has emerged as a crucial international public health concern. In ocular examinations of children under noncycloplegic conditions, the influence of accommodation cannot be disregarded.
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Cycloplegic refraction is widely regarded as the gold standard in epidemiological assessment of refractive errors in pediatric populations. Moreover, due to children's decreased cooperation and unreliable responses, subjective refraction tests are less valued, and objective tests under cycloplegia are preferred. The portable vision screener 2WIN-S is a binocular tool that detects various ocular abnormalities and measures the refraction of both eyes. Along with measuring phorias/tropias in prismatic diopters and objective refraction in the range of -15D to +15D, 2WIN-S also captures additional features.
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This study employed the cycloplegic condition to measurements using 2WIN-S, ARK-1 and subjective testing, we wanted to test the reliability and accuracy of 2WIN-S. conditions: Optometry studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 150 type: ESTIMATED measure: The optometric result (2WIN-S) measure: The optometric result(ARK-1) measure: The optometric result(subjective refraction) measure: The optometric result sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06346613 id: B2024-076R briefTitle: Prevalence and Affecting Factors of Sleep and Circadian Rhythm Disorders in ICU overallStatus: RECRUITING date: 2024-03-07 date: 2025-01-31 date: 2025-12-31 date: 2024-04-04 date: 2024-04-04 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: Most ICU patients experience sleep and circadian disruption (SCD), which causes a profound negative impact on patients, such as prolonged mechanical ventilation, glucose intolerance, and the occurrence of delirium. In order to better promote the alignment of circadian rhythm in ICU patients, this project will explore the prevalence of SCD and a series of influencing factors contributing to SCD in ICU patients, to help construct targeted intervention programs in the future. conditions: Sleep Deprivation conditions: Circadian Rhythm Disorders conditions: Critical Illness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 56 type: ESTIMATED measure: Rhythmicity of melatonin levels. measure: Overnight sleep duration measure: Wake after sleep onset(WASO) measure: Overnight Rapid Eye Movement (REM) proportion measure: Overnight non-rapid eye movement stage 1 (NREM1) proportion measure: Overnight non-rapid eye movement stage 2 (NREM2) proportion measure: Overnight non-rapid eye movement stage 3 (NREM3) proportion measure: Sleep period time ratio (sleep continuity) measure: Subject sleep quality measure: Activity counts sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 180 Fenglin Road status: RECRUITING city: Shanghai zip: 20032 country: China name: Shining Cai, MSc role: CONTACT phone: 86-021-64041990 phoneExt: 2724 email: [email protected] name: Yuxia Zhang, PhD role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06346600 id: SKG0106-LF briefTitle: A Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With nAMD overallStatus: RECRUITING date: 2024-04-02 date: 2031-03 date: 2031-03 date: 2024-04-04 date: 2024-04-04 name: Skyline Therapeutics class: INDUSTRY briefSummary: This is a Prospective, Non-interventional, Multicenter, Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients with Neovascular (Wet) Age-related Macular Degeneration (nAMD). All subject who completed the parent clinical study (NCT06213038 and NCT05986864) will undergo safety and efficacy assessments up to 5 years post study drug injection. conditions: Neovascular (Wet) Age-related Macular Degeneration studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 83 type: ESTIMATED name: SKG0106 measure: Type, severity, and incidence of ocular and systemic adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) measure: Mean change in best corrected visual acuity (BCVA) at each visit from baseline measure: Mean change in macular central subfield thickness (CST) at each visit from baseline measure: Mean change in patient-reported outcome (VFQ-25) scale scores at each visit from baseline sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ophthalmic Consultants of Boston status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States lat: 42.35843 lon: -71.05977 facility: Retina Consultants of Texas status: NOT_YET_RECRUITING city: Katy state: Texas zip: 77494 country: United States lat: 29.78579 lon: -95.8244 facility: Wagner Macula & Retina Center status: NOT_YET_RECRUITING city: Norfolk state: Virginia zip: 23502 country: United States lat: 36.84681 lon: -76.28522 facility: The Second Hospital Of Anhui Medical University status: NOT_YET_RECRUITING city: Hefei state: Anhui country: China lat: 31.86389 lon: 117.28083 facility: Zhejiang Provincial People's Hospital status: NOT_YET_RECRUITING city: Hangzhou state: Zhejiang country: China lat: 30.29365 lon: 120.16142 facility: Eye Hospital, WMU (Zhejiang Eye Hospital) status: NOT_YET_RECRUITING city: Wenzhou state: Zhejiang country: China lat: 27.99942 lon: 120.66682 facility: Beijing Hospital status: NOT_YET_RECRUITING city: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing country: China lat: 39.9075 lon: 116.39723 facility: EYE & ENT Hospital of Fudan University status: RECRUITING city: Shanghai country: China lat: 31.22222 lon: 121.45806 facility: Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine status: NOT_YET_RECRUITING city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06346587 id: VRU751-C001 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-04 date: 2024-04-23 name: [Redacted] hasResults: False
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<|newrecord|> nctId: NCT06346574 id: STUDY-0004282 briefTitle: HEART at Head Start Pilot (Healthy Eating, Activity, Relaxation Trial) acronym: HEART overallStatus: RECRUITING date: 2023-12-14 date: 2024-11 date: 2024-12 date: 2024-04-04 date: 2024-04-04 name: Tufts University class: OTHER name: United States Department of Agriculture (USDA) name: National Head Start Association briefSummary: With funding from the United States Department of Agriculture (USDA), the Tufts University's Friedman School of Nutrition Science and Policy will be implementing a new, health and wellbeing program for Head Start educators at ABCD Head Start Centers in the greater Boston area.
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The purpose of this study is to evaluate the combined impact of a health and wellness program and behavior change guides. The evaluation will focus on ABCD Head Start educators as the study population. Tufts University's Friedman School of Nutrition Science and Policy is responsible for implementing and evaluating this new intervention through surveys and analysis of administrative (health and wellness App) data.
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A paper and pencil survey will be used to gather information on dietary, physical activity, and sleep behaviors. The surveys will also include a module on satisfaction with the health and wellness App and Guides. Survey data will be combined with the administrative data about App utilization. conditions: Dietary Habits conditions: Physical Inactivity conditions: Sleep Hygiene studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Study participants will be educators at Head Start centers where either the intervention is offered at the onset of the study (intervention group) or after six months (comparison condition). primaryPurpose: OTHER masking: NONE count: 200 type: ESTIMATED name: Experimental measure: Use of health and wellness App measure: Engagement with Guide measure: Nutrition behaviors measure: Physical activity behaviors measure: Sleep habits measure: BMI measure: Cholesterol measure: Triglycerides measure: Blood pressure measure: Blood glucose sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tufts University status: RECRUITING city: Boston state: Massachusetts zip: 02111 country: United States name: Katrina Sarson, MS, MEd role: CONTACT phone: 617-636-3737 email: [email protected] name: Sujata Dixit-Joshi, MPH, PhD role: CONTACT phone: 617-636-3737 email: [email protected] name: Christina Economos, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06346561 id: Soh-Med-24-02-10MS briefTitle: The Efficacy of Dexmedetomidine Versus Labetalol In Providing Controlled Hypotension In Dacryocystorhinostomy SurgeryA Comparative Randomized Prospective Study overallStatus: RECRUITING date: 2024-03-30 date: 2024-08-30 date: 2024-08-30 date: 2024-04-04 date: 2024-04-04 name: Sohag University class: OTHER briefSummary: The most important symptoms of nasolacrimal duct obstruction are excessive tearing and mucoid discharge.
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The proposed treatment in this regard is dacryocystorhinostomy (DCR) surgery. Therefore, hemostasis is of great significance in performing DCR surgery. In this regard, the reduction of controlled hypotension and the control of hemodynamic responses of the body to stress effectively reduce the bleeding volume during surgery.
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Hence, there is no enough studies about controlled hypotension in DCR we decided to perform such a comparison between the effect of dexmedetomidine and labetalol in providing controlled hypotension during DCR surgery. conditions: Nasolacrimal Duct Obstruction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Dexmedetomidine name: Labetalol measure: Assess non invasive blood pressure during DCR surgery To compare between the effect of dexmedetomidine and labetalol in providing controlled hypotension. measure: Effectiveness of dexamedetomidine for prolongation of postoperative analgesia. sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Sohag University hospitals status: RECRUITING city: Sohag country: Egypt name: Magdy M Amin, Professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False
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<|newrecord|> nctId: NCT06346548 id: VF-ES-DIG briefTitle: Study on the Chromatic Perception of Digital Systems in Aesthetic Field overallStatus: NOT_YET_RECRUITING date: 2024-09-27 date: 2025-06-15 date: 2025-06-15 date: 2024-04-04 date: 2024-04-04 name: Paolone Gaetano class: OTHER briefSummary: The study under consideration aims to evaluate differences in chromatic perception among three distinct color acquisition methodologies. Specifically, recruited patients will undergo testing with three different color detection systems, including two intraoral photography methodologies and one digital intra oral scanning. All procedures conducted are part of normal clinical practice. conditions: Color Detection of Upper Central Incisors studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 78 type: ESTIMATED name: oral photography measure: Comparison of chromatic values of the upper central incisors sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS San Raffaele city: Milano zip: 20132 country: Italy name: Federico Vannini role: CONTACT phone: +393450764177 email: [email protected] lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06346535 id: 2022-05703-01 briefTitle: PrimeCog: Primary Care Cognitive Testing acronym: PrimeCog overallStatus: RECRUITING date: 2024-04-01 date: 2027-04-01 date: 2029-04-01 date: 2024-04-04 date: 2024-04-23 name: Region Östergötland class: OTHER briefSummary: The PrimeCog study aims to describe the symptomatology and pathophysiology of stress-induced exhaustion disorder (SED) and major depressive disorder (MDD) compared to healthy controls (HC). The participants will be recruited at primary care centers, and samples of blood, saliva, and hair will be collected. Digital questionnaires covering psychosocial variables and screening instruments for the detection of depression, anxiety, etc., along with a digital cognitive test battery, will be performed at home. Subsequently, an MRI of the brain will be performed, and analysis of biomarkers for stress, inflammation, and neurodegeneration will be conducted. These procedures will be repeated after twelve and twenty-four months. The study will investigate differences in the biomarkers, neuroimaging findings, and cognitive abilities between patients with SED, MDD, and controls over time. Associations between the symptom severity of MDD/SED and psychosocial variables, cognition, MRI, and the biomarkers will also be examined. The aim is to provide new diagnostic tools for differentiation between MDD and SED and guide individualized treatment based on underlying pathophysiology and cognitive function. All necessary competences for conducting this extensive study are represented within the research group. The PrimeCog study is unique in its comprehensive design, addressing knowledge gaps, and directly comparing these diagnoses over time in primary care, where patients are typically treated. conditions: Mental Health Issue conditions: Cognitive Symptom conditions: Primary Health Care studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Cognitive Testing measure: Cognitive Test Results regarding attention and processing speed measure: Cognitive Test Results regarding attention and processing speed measure: Cognitive Test Results regarding attention and processing speed measure: Cognitive Test Results regarding attention and processing speed measure: Cognitive Test Results regarding memory measure: Cognitive Test Results regarding memory measure: Cognitive Test Results regarding executive function measure: Cognitive Test Results regarding executive function measure: Cognitive Test Results regarding executive function measure: Cognitive Test Results regarding language measure: Cognitive Test Results regarding language measure: Cognitive Test Results regarding visuospatial capacity measure: MRI features, measured by morphological and quantitative MR sequences of the brain measure: Biochemical Profile in blood regarding inflammation, stress and neurodegeneration measure: Biochemical Profile in saliva regarding inflammation and stress measure: Biochemical Profile in hair regarding exposure to stress sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Region Ostergotland, primary care centrum status: RECRUITING city: Linköping state: Ostergotland country: Sweden name: Hanna Israelsson Larsen, PhD role: CONTACT phone: 0738317008 email: [email protected] name: Anna Segernas, PhD role: CONTACT phone: +46733641430 email: [email protected] name: Hanna Israelsson Larsen, PhD role: PRINCIPAL_INVESTIGATOR name: Anna Segernäs, PhD role: PRINCIPAL_INVESTIGATOR lat: 58.41086 lon: 15.62157 hasResults: False
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<|newrecord|> nctId: NCT06346522 id: FMASU R37/2024 briefTitle: Gabapentin Versus Trospium Chloride for Prevention of a Catheter-related Bladder Discomfort Inside the ICU overallStatus: RECRUITING date: 2024-02-24 date: 2024-07 date: 2024-08 date: 2024-04-04 date: 2024-04-04 name: Ain Shams University class: OTHER briefSummary: Catheter-related bladder discomfort (CRBD) is a frequent complaint after urinary bladder catheterization which is commonly done in the perioperative period. CRBD shows similar symptoms to overactive bladder (OAB); so, drugs used for the management of OAB could influence symptoms of CRBD. Trospium chloride and gabapentin are effective in managing patient with OAB even the resistant cases. We will evaluate and compare the efficacy of both oral trospium and gabapentin on prevention of CRBD in the postoperative period in the ICU in in patients undergoing spinal surgery and requiring intraoperative catheterization of the urinary bladder. conditions: Catheter-related Bladder Discomfort (CRBD) studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A prospective, randomized, comparative, clinical trial study primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Gabapentin (Gaptin ®) 400mg oral capsule once name: Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule measure: The incidence (yes/no) and severity of catheter-related bladder discomfort (CRBD) in 1,2,6,12,24 hours after the study drugs intake measure: Total fentanyl requirements in micrograms (µg) measure: Numerical Pain Rating Scale (NPRS) (0-10) measure: Side effects of the study drugs measure: Ramsay sedation score sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Ain Shams University-Faculty of Medicine status: RECRUITING city: Cairo country: Egypt name: Ahmed M Mohamed, MD role: CONTACT phone: 002 01121318459 email: [email protected] name: Wessam Z Selima, MD role: CONTACT phone: 002 01001958858 email: [email protected] lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06346509 id: PORT-77-101 briefTitle: Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of PORT-77 Administered to Healthy Adult Participants overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-12-23 date: 2024-12-23 date: 2024-04-04 date: 2024-04-04 name: Portal Therapeutics, Inc. class: INDUSTRY briefSummary: A First-in-Human 2-part, randomized, double-blind, placebo-controlled, single ascending dose, multiple ascending dose, and food effect, investigation of the administration of PORT-77 in healthy adult participants. conditions: Healthy Adult Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 108 type: ESTIMATED name: PORT-77 name: Placebo measure: Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of PORT-77 (Part I) measure: Number of incidence and severity of AEs as a measure of safety and tolerability of PORT-77 (Part II) measure: Plasma concentration of a single-dose of PORT-77 (Part I) measure: Plasma concentration of the steady-state of PORT-77 (Part II) measure: Plasma concentration of PORT-77 by effect of a standardized high-fat/high-calorie meal (Part I) measure: Evaluate effects of single doses of PORT-77 on ECG parameters (Part I) measure: Evaluate effects of single doses of PORT-77 on ECG parameters (Part II) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Celerion city: Tempe state: Arizona zip: 85283 country: United States role: CONTACT email: [email protected] name: Mara Baier, DO role: PRINCIPAL_INVESTIGATOR lat: 33.41477 lon: -111.90931 hasResults: False
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<|newrecord|> nctId: NCT06346496 id: H23133 briefTitle: Young People Aged 18-25 With Depression or Anxiety Mood Participate in an LLM-based Digital Dialogue Intervention Study overallStatus: COMPLETED date: 2023-11-20 date: 2023-12-18 date: 2024-01-15 date: 2024-04-04 date: 2024-04-09 name: Institute of Psychology, Chinese Academy of Sciences class: OTHER briefSummary: This study is a 28-day randomized controlled trial (RCT). Residents were randomly assigned to an intervention group or a waiting group according to the order in which they were successfully contacted by the staff, and each user was asked to engage in a total of 28 days of dialog intervention with the Douyin companion bot and complete three psychological questionnaires (on Days 1, 14, and 28); however, the intervention group began to receive the dialog intervention after completing the first questionnaire, and the waiting group began to receive the dialog intervention after completing the third questionnaire. During the first four weeks, the waiting group was treated as a blank control. The two groups of subjects completed the three questionnaires at exactly the same point in time. Each user's depression, anxiety, and positive and negative emotions were measured using the Patient Health Questionnaire (PHQ-9), the Generalized Anxiety Disorder Scale (GAD-7) and the Positive and Negative Affect Schedule (PANAS), respectively. conditions: LLM-based AI Dialogue Bot conditions: Depression conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 657 type: ACTUAL name: Douyin Xinqing AI dialog bot name: Douyin Xinqing AI dialog bot for delayed intervention measure: Depression measure: Anxiety measure: Positive and negative moods sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Institute of Psychology, Chinese Academy of Sciences city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06346483 id: STU00218929 briefTitle: Ureteroscopy With High-powered Holmium:Yag Laser Lithotripsy With and Moses On or Moses Off overallStatus: RECRUITING date: 2023-06-09 date: 2024-06-09 date: 2025-06-09 date: 2024-04-04 date: 2024-04-04 name: Northwestern University class: OTHER name: Ohio State University briefSummary: The purpose of this study is to compare Moses 2.0 pulse modulation technology and the standard high powered Holmium Laser lithotripsy and how it will affect time in the operating room, time using the laser, laser energy, and stone free rates.
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Currently Moses 2.0 laser technology is FDA approved and currently used in practice since 2021. No study to this date has compared Moses 2.0 without pulse modulation laser technology to Moses 2.0 with pulse modulation laser technology.
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The study will be including kidney and ureteral stones (a kidney stone located in the tube between the kidney and the bladder) that are 6mm and greater, but less than 20 mm in size undergoing ureteroscopic treatment. High powered lasers are used for "dusting". Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine. conditions: Kidney Stone conditions: Ureteral Stone studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Dusting measure: Operative time measure: Stone Free Rate measure: Lasing time measure: Total laser energy (kJ) measure: Detection of postoperative strictures sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwestern Medicine status: RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Alyssa McDonald role: CONTACT lat: 41.85003 lon: -87.65005 hasResults: False
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<|newrecord|> nctId: NCT06346470 id: 3430-12 briefTitle: The Effect of Web-Based Breast Self-Examination Education overallStatus: RECRUITING date: 2024-02-19 date: 2024-05-31 date: 2024-05-31 date: 2024-04-04 date: 2024-04-04 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: Breast cancer is the most common type of cancer among women. Reasons such as diagnosing breast cancer at an early stage increases the chances of treatment and survival, and the fact that the masses are largely noticed by the individual themselves, point to the importance of breast self-examination (BSE) . BSE skill is among the nursing skills. When the literature was examined, it was seen that the web-based education method was frequently used for cognitive skills during nursing education, but its use was limited for psychomotor skills training. It was determined that in BSE training, in addition to traditional education, methods such as concept maps and peer-supported education were used, but web-based education methods were not used. It is thought that the study will contribute to the literature in these aspects. conditions: Education conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 88 type: ESTIMATED name: Web-based breast self examination education measure: Skill and Knowledge of BSE measure: Attitude of Web-Based Education measure: Self-Directed Learning Skills sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Florence Nightingale Faculty of Nursing status: RECRUITING city: Istanbul state: Şişli zip: 34381 country: Turkey name: Olga İncesu, PhD role: CONTACT phone: 05334942989 email: [email protected] name: Olga İncesu, PhD role: PRINCIPAL_INVESTIGATOR name: Öykü Kara, Msc role: SUB_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06346457 id: IRTG_P08 briefTitle: Breast Cancer & Antiestrogenic Therapy & Brain overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-01 date: 2026-04-01 date: 2024-04-04 date: 2024-04-04 name: International Research Training Group 2804 class: OTHER name: German Research Foundation name: University Hospital Tuebingen name: Uppsala University briefSummary: The study aims to investigate the effect of anti-estrogenic therapy in breast cancer patients on neural reward processing, psychosexual health, and quality of life, in reproductive vs. menopausal women. The investigators are directly comparing four groups 1) premenopausal women diagnosed with breast cancer receiving anti-estrogenic therapy, 2) postmenopausal women diagnosed with breast cancer with and without previous hormonal replacement therapy, receiving anti-estrogenic therapy, 3) premenopausal healthy women, and 4) postmenopausal healthy women. Furthermore, via assessment and integration of various data including subjective/self-report data via questionnaires and a standardized interview, physiological/endocrine (via blood sample), psychological and neural data (including anatomical scans, Diffusion tensor imaging (DTI), resting state, and a reward processing paradigm), this project will shed light on the connection between the brain, anti-estrogenic therapy, and psychosexual health. conditions: Breast Cancer Female conditions: Healthy Female conditions: Menopause conditions: Anti-estrogenic Therapy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 180 type: ESTIMATED name: Tamoxifen name: Letrozole name: Letrozole + GnRH measure: Correlations between antiestrogen hormone therapy and brain function & structure measure: Correlations between antiestrogen hormone therapy and reward processing in both behavioral and neural aspects measure: Brain Disparities: Contrasting Breast Cancer Patients with Healthy Controls measure: Reward Processing Disparities: Contrasting Breast Cancer Patients with Healthy Controls measure: Brain Disparities: Contrasting Breast Cancer Patients with Healthy Controls measure: Correlation between antiestrogen hormone therapy and psychosexual health measure: Correlation between antiestrogen hormone therapy and quality of life measure: Psychosexual Health Disparities: Contrasting Breast Cancer Patients with Healthy Controls measure: Psychosexual Health Disparities: Contrasting Breast Cancer Patients with Healthy Controls measure: Correlation between antiestrogen hormone therapy and cognitive changes measure: Quality of Life Disparities: Contrasting Breast Cancer Patients with Healthy Controls sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Tuebingen; Department of Psychiatry & Psychotherapy Tuebingen city: Tuebingen state: BW zip: 72076 country: Germany lat: 48.52266 lon: 9.05222 hasResults: False
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<|newrecord|> nctId: NCT06346444 id: 2.780.113 briefTitle: Biomarkers in Rett Syndrome acronym: BIRS overallStatus: RECRUITING date: 2020-08-03 date: 2024-02-20 date: 2024-12-31 date: 2024-04-04 date: 2024-04-04 name: IRCCS Fondazione Stella Maris class: OTHER name: Meyer Children's Hospital IRCCS name: Azienda USL Toscana Nord Ovest name: University of Dublin, Trinity College briefSummary: Rett syndrome (RTT) is an X-linked genetic disorder that causes severe neurological development disorder. In its classic form, it seems to affect almost exclusively females with an incidence of up to one in 10,000 females. Patients affected by Rett Syndrome can present a wide range of symptoms, in different combinations and of varying intensity, such as slowed growth of head circumference, abnormalities in walking and balance, loss of functional use of the hands often replaced by repetitive and stereotyped hand movements like "hand washing", loss of communicative-relational skills including expressive language, epilepsy, breathing abnormalities, and osteo-muscular alterations. In light of the growing potential of clinical therapies, identification and early diagnosis are considered essential. Many disease modification strategies have been achieved through translational research studies and clinical trials that have allowed the recognition of the most effective therapeutic and clinical interventions to date.
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This study arises from the need to advance in the understanding of the pathogenesis of RTT through a multicentric collaboration in order to (a) identify early biomarkers of RTT (b) delve into the alterations of interconnectivity, crucial for understanding the loss of motor functions and language through systematic collection of anamnestic, genetic, and clinical-instrumental data. The aim is to provide a valuable contribution to the study of the clinical phenotype of Rett and the identification of early interventions. conditions: Rett Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Diagnostic test and behavioral measure: Age at diagnosis measure: Mutation in MECP2 measure: Neuroscope alterations measure: Electroencephalogram (EEG) alterations measure: Brain magnetic resonance imaging (MRI) alteration measure: Bone densitometry alterations measure: Thoracic radiographic alterations measure: Lumbosacral spine radiographic alterations measure: Clinical Global Impression (CGI) scale measure: The Rett Syndrome Behavioural Questionnaire (RSBQ) measure: Alterations of neurovisual functions measure: Possibility of applying alternative forms of communication to verbal communication sex: FEMALE minimumAge: 0 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Trinity College Institute of Neuroscience, Lloyd Building, D2 status: RECRUITING city: Dublin country: Ireland name: Daniela Tropea role: CONTACT email: [email protected] lat: 53.33306 lon: -6.24889 facility: Ospedale Versilia Centro di Riferimento status: RECRUITING city: Lido Di Camaiore state: Lucca zip: 55049 country: Italy name: Ilaria Gemo role: CONTACT email: [email protected] lat: 43.90012 lon: 10.2269 facility: IRCCS Fondazione Stella Maris status: RECRUITING city: Calambrone state: Pisa zip: 56128 country: Italy name: Roberta Battini role: CONTACT phone: 050886282 email: [email protected] lat: 43.58333 lon: 10.3 facility: AOU Meyer status: RECRUITING city: Firenze zip: 50139 country: Italy name: Viola Doccini role: CONTACT email: [email protected] lat: 43.77925 lon: 11.24626 hasResults: False
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<|newrecord|> nctId: NCT06346431 id: 20240301 briefTitle: Efficacy of Digital Problem Solving Application in Reduction of Anxiety, Depression and Substance Use Disorder Symptoms acronym: Efficacy overallStatus: NOT_YET_RECRUITING date: 2026-03 date: 2026-11 date: 2026-12 date: 2024-04-04 date: 2024-04-04 name: 7 Generation Games class: INDUSTRY briefSummary: The focus of this study is the impact of usage of a mobile application to support problem-solving therapy on symptoms of anxiety, depression and substance use. conditions: Anxiety conditions: Depressive Symptoms conditions: Substance Use Disorders studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: DSPT - Digital Support for Problem-solving Therapy measure: Generalized Anxiety Disorder Scale-7 measure: Center for Epidemiological Studies Depression Scale measure: Drug Abuse Screening Test measure: Michigan Alcohol Screening Test sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06346418 id: PNRR-MR1-2022-12376622 briefTitle: Maternal Genes and Epimutations: Beckwith-Wiedemann Syndrome & Reproductive Risks overallStatus: RECRUITING date: 2023-05-19 date: 2025-01 date: 2025-05 date: 2024-04-04 date: 2024-04-04 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER name: Istituto Auxologico Italiano name: Università degli Studi della Campania Luigi Vanvitelli name: Federico II University briefSummary: Pathogenic variants in subcortical maternal complex (SCMC) have been identified not only in mothers of Beckwith-Wiedemann syndrome (BWS) babies but also in women with reproductive disturbances such as failed pregnancy attempts and recurrent pregnancy loss. Based on the higher incidence of BWS in children born from Assisted Reproductive Technology (ART), this project aims to investigate incidence and molecular mechanism of pathogenic variants of SCMC in women with reproductive disorders. Study objectives will be (i) assess the incidence of these variants as a cause of differences in reproductive outcomes in the infertile female population and mothers of children with BWS; (ii) identify methylation changes in women with reproductive problems including those with offspring affected by BWS; (iii) determine the molecular causes underlying female infertility and imprinting disorder associated with damaging SCMC gene variants by employing a mouse model. conditions: Beckwith-Wiedemann Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 208 type: ESTIMATED name: WES analysis name: whole-genome methylation analysis measure: MEG Incidence measure: Compare DNA methylation sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: RECRUITING city: Milan zip: 20122 country: Italy name: Edgardo Somigliana, PhD role: CONTACT phone: +390255034303 email: [email protected] lat: 45.46427 lon: 9.18951 facility: Istituto Auxologico Italiano status: RECRUITING city: Milan zip: 20145 country: Italy name: Silvia Russo, Phd role: CONTACT phone: +393493237520 email: [email protected] lat: 45.46427 lon: 9.18951 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2022-12-20 uploadDate: 2024-03-28T05:11 filename: Prot_SAP_000.pdf size: 817568 hasResults: False
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