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<|newrecord|> nctId: NCT06375304 id: MP-37-2024-10384 briefTitle: The Antiretroviral Speed Access Program Switch (ASAP-Switch) Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-06-01 date: 2027-05-01 date: 2024-04-19 date: 2024-04-19 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER briefSummary: This project builds on our experience with the ASAP Study (McGill University Health Centre research ethics board: MP-37-2020-4911). The goal of this study is to better understand the experience of migrant people with Human Immunodeficiency Virus (HIV) of having their treatment switched to Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). In other words, the investigators want to evaluate how feasible and acceptable this switch is, and how participants will take B/F/TAF (fidelity) and remain on it. The investigators also want to know more about migrant people with HIV's experience of care; namely, how often they see their HIV specialist or other healthcare professionals, and their healthcare coverage (the type of insurance that they have). conditions: HIV Infections studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: B/F/TAF measure: Feasibility of the switch measure: Acceptability measure: acceptability of the regimen measure: Acceptability of the intervention measure: Fidelity measure: ART initiation (HIV care cascade milestones) measure: Viral suppression (HIV care cascade milestones) measure: Retention in HIV care (HIV care cascade milestones) measure: consultations at the study site (Nature of clinical pathways) measure: consultations at other care centres or organizations (Nature of clinical pathways) measure: healthcare coverage sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Institute of the McGill University Health Centre city: Montréal state: Quebec zip: H4A3T2 country: Canada name: Bertrand Lebouché, MD, PhD role: CONTACT phone: +1-514-843-2090 email: [email protected] name: Ashkan Baradaran, MD, MSc role: CONTACT phone: +1 514-863-4468 email: [email protected] lat: 45.50884 lon: -73.58781 hasResults: False |
<|newrecord|> nctId: NCT06375291 id: MersinTRHpregcts briefTitle: Pregnancy-Related Carpal Tunnel Syndrome Treatment overallStatus: COMPLETED date: 2021-01-01 date: 2023-12-31 date: 2024-03-31 date: 2024-04-19 date: 2024-04-22 name: Mersin Training and Research Hospital class: OTHER_GOV briefSummary: The current retrospective study aimed to compare the effectiveness of local steroid injection plus splinting with that of local steroid injection or splinting alone. To assess the primary outcome, The Boston Carpal Tunnel Symptom Severity Scale was used. The secondary aim was the efficacy of the treatment on the patient's function severity and depression assessed by The Boston Carpal Tunnel Symptom Function Scale Edinburgh Depression Scale. conditions: Carpal Tunnel Syndrome Pregnancy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 45 type: ACTUAL name: splint /steroid injection/both measure: Symptom severity measure: function severity measure: pregnancy and postpartum depression sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Suna Aşkın Turan city: Mersin state: Yenişehir zip: 33020 country: Turkey lat: 36.79526 lon: 34.61792 hasResults: False |
<|newrecord|> nctId: NCT06375278 id: DC019586 id: 5R44DC019586 type: NIH link: https://reporter.nih.gov/quickSearch/5R44DC019586 briefTitle: Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-31 date: 2026-03-31 date: 2024-04-19 date: 2024-04-19 name: Restorear Devices LLC class: INDUSTRY name: University of Miami name: National Institute on Deafness and Other Communication Disorders (NIDCD) briefSummary: The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are: |
1. Is mild therapeutic hypothermia safe for use during cochlear implantation? |
2. Is mild therapeutic hypothermia effective at preserving residual hearing after cochlear implantation? |
Participants will receive mild therapeutic hypothermia therapy during cochlear implant surgery. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy). conditions: Cochlear Implants conditions: Cochlear Implantation conditions: Hearing Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Intra-Ear Canal Cooling Catheter name: Intra-Ear Canal Cooling Catheter (Sham) measure: Cochlear Implant (CI) Device Performance Following Hypothermia Treatment measure: Residual Hearing measure: Electrophysiological Impedance measure: Electrically Evoked Compound Action Potential (ECAP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami city: Miami state: Florida zip: 33136 country: United States lat: 25.77427 lon: -80.19366 hasResults: False |
<|newrecord|> nctId: NCT06375265 id: 2024P000780-1 briefTitle: Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients acronym: SLEEP-BOOST overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2026-05-31 date: 2026-08-31 date: 2024-04-19 date: 2024-04-19 name: Massachusetts General Hospital class: OTHER briefSummary: The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested cognitive behavioral therapy for insomnia (CBT-I) mobile application paired with a wearable device (wrist actigraphy). conditions: Insomnia conditions: Postoperative Delirium conditions: Delayed Neurocognitive Recovery conditions: Postoperative Neurocognitive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) name: Sleep Health Education measure: Adherence measure: Insomnia Severity measure: Sleep Diary Completion measure: Homework Completion measure: Utility measure: Satisfaction with intervention measure: Cognition measure: Pain severity measure: Mood measure: Anxiety measure: Function measure: Postoperative Delirium Incidence measure: Postoperative Delirium Severity measure: Delayed Neurocognitive Recovery measure: Postoperative Neurocognitive Disorders (NCD) measure: Sleep Efficiency measure: Circadian Rest-Activity Rhythms sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States lat: 42.35843 lon: -71.05977 hasResults: False |
<|newrecord|> nctId: NCT06375252 id: sbughfyaseminozkan1985 briefTitle: Evaluation of Central Jugular Vein Catheter Lumen Holder Design and Ergonomic Use acronym: CJVClumen overallStatus: NOT_YET_RECRUITING date: 2024-04-19 date: 2024-05-16 date: 2024-05-30 date: 2024-04-19 date: 2024-04-19 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: The aim of this study was to evaluate the design and ergonomic use of central jugular vein catheter lumen holder. conditions: Central Venous Catheterization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 40 type: ESTIMATED name: Central Jugular Vein Catheter Lumen Holder Apparatus measure: demographic information measure: comfort effect sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375239 id: RTx-VRAI-NHS01 briefTitle: Observational Study to Assess Endpoint Operational Feasibility & Measurement Properties in Retinitis Pigmentosa Patients overallStatus: RECRUITING date: 2024-04-05 date: 2026-04-30 date: 2026-04-30 date: 2024-04-19 date: 2024-04-19 name: Ray Therapeutics, Inc. class: INDUSTRY name: The Vision Research and Assessment Institute (VRAI) briefSummary: RayTx established The Vision Research and Assessment Institute (VRAI) with the express purpose of serving as a testing facility for efficacy endpoints for patients with Low Vision. The mission of the VRAI is to enable the highest quality, standardized efficacy testing of patients with visual impairment to be performed by expert clinicians in an optimized environment. The proposed assessments or testing modalities to be evaluated in this non-interventional study are published in some capacity, and some of these publications already include patients with severe-to-profound vision loss from retinitis pigmentosa and other inherited retinal diseases. conditions: Retinitis Pigmentosa studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Operational feasibility of testing severe to profound vision impaired patients with RP on a battery of visual assessments measure: To quantify patient-based measurement properties of each test modality (for the purposes of endpoint qualification) measure: To quantify assessor-based measurement properties of each test modality (for the purposes of endpoint qualification) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vision Research and Assessment Institute status: RECRUITING city: Irvine state: California zip: 92612 country: United States name: Shawn Yu, OD role: CONTACT phone: 949-264-3793 email: [email protected] lat: 33.66946 lon: -117.82311 hasResults: False |
<|newrecord|> nctId: NCT06375226 id: 2023.17 id: 2023.0871 type: OTHER domain: METC Amsterdam UMC briefTitle: Autism and Attachment. An Explorative Study of Attachment Styles in Autistic Adults. acronym: ASDA overallStatus: RECRUITING date: 2024-03-01 date: 2025-04-01 date: 2025-04-01 date: 2024-04-19 date: 2024-04-23 name: Parnassia Groep class: OTHER briefSummary: The present study examines the relationship between attachment and autism spectrum disorder (ASD) in adults. conditions: Autism Spectrum Disorder studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: The Social Responsiveness Scale - Adult version (SRS-A) measure: The Attachment Styles Questionnaire (ASQ) measure: Experiences in Close Relationships - Revised questionnaire (ECR-r) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ParnassiaGroep Antes status: RECRUITING city: Rotterdam state: Zuid-Holland zip: 3083 AK country: Netherlands name: Stephanie Bohnen, MSc role: CONTACT phone: +31653386139 email: [email protected] name: Richard Vuijk, Dr. role: CONTACT phone: +31883585428 email: [email protected] lat: 51.9225 lon: 4.47917 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-10-19 uploadDate: 2024-03-29T08:28 filename: Prot_SAP_000.pdf size: 287252 hasResults: False |
<|newrecord|> nctId: NCT06375213 id: 425/66 briefTitle: Investigating Neurocognitive Disorders Epidemiology acronym: INDE overallStatus: RECRUITING date: 2023-08-24 date: 2035-08-24 date: 2035-08-24 date: 2024-04-19 date: 2024-04-22 name: King Chulalongkorn Memorial Hospital class: OTHER name: Health Systems Research Institute,Thailand briefSummary: This is a prospective cohort study with the main purpose of predicting progression neurocognitive disorders in Thai population. The main predictor variables to be evaluated are plasma phosphorylated tau (p-tau) level and cognitive test scores, which will be combined using statistical/computational modeling. Additionally, it seeks to evaluate biomarkers for diagnosing disease pathologies, understand their correlation with clinical outcomes, and explore the socioeconomic impact of neurocognitive disorders. The study invites both participants for biospecimen collection, structured interviews, and cognitive examinations and schedules follow-up visits annually or biennially. conditions: Dementia conditions: Cognitive Decline conditions: Alzheimer Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 990 type: ESTIMATED name: Plasma tau phosphorylated at Thr217 name: Neurocognitive examination measure: Progression to dementia measure: Changes in Sum of Boxes of the Clinical Dementia Rating Scale measure: Changes in the Montreal Cognitive Assessment measure: Changes in the Montreal Cognitive Assessment - Memory Index Score measure: Changes in the Mini Mental State Examination measure: Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Visual Reproduction Scaled Score measure: Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Logical Memory Scaled Score measure: Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Verbal Paired Associates Scaled Score measure: Biological diagnosis of Alzheimer's disease measure: Biological staging of Alzheimer's disease measure: Quantitative amyloid PET uptake. measure: Quantitative tau PET uptake in various cortical regions. measure: Future diagnosis of Alzheimer's disease dementia. measure: Quality of life (WHOQOL-BREF) measure: Quality of life (EQ-5D-5L) measure: Number of modifiable risk factors sex: ALL minimumAge: 35 Years stdAges: ADULT stdAges: OLDER_ADULT facility: King Chulalongkorn Memorial Hospital status: RECRUITING city: Pathum Wan state: Bangkok zip: 10330 country: Thailand name: Adipa Chongsuksantikul, D.Eng. role: CONTACT phone: +66 (0)84 1134443 email: [email protected] lat: 13.73649 lon: 100.5239 hasResults: False |
<|newrecord|> nctId: NCT06375200 id: ONZ-2024-0066 briefTitle: Healthcare for Men With Suicidal Thoughts: Needs Assessment acronym: KUJK2NEEDS overallStatus: RECRUITING date: 2024-04-25 date: 2024-07-01 date: 2024-10-10 date: 2024-04-19 date: 2024-04-29 name: University Ghent class: OTHER briefSummary: The aim of the current project is twofold, namely |
1. To gain insight into needs related to help-seeking among men with (previous) suicidal thoughts (STUDY 1). More specifically, this study examines help-seeking behaviour, possible barriers to seeking help and needs with regard to existing tools and health care among men who had suicidal thoughts. In other words, is there a difference in help-seeking behaviour between men and women with suicidal thoughts in the past and what factors contribute to this difference? More specifically: |
1. To what extent do men with suicidal thoughts in the past recognize their need for help, compared to women with suicidal thoughts in the past? |
2. What barriers and needs do men with suicidal thoughts in the past experience towards seeking help, compared to women with suicidal thoughts in the past? |
3. What barriers and needs do men with suicidal thoughts in the past experience to remain engaged in help, compared to women with suicidal thoughts in the past? |
2. To map out needs of healthcare providers in working with men with suicidal thoughts and/or behaviour (STUDY 2). More specifically, how do healthcare providers experience working with men who are feeling suicidal and what are their experienced barriers and needs. Two main research questions were formulated: |
1. How do health care providers experience working with men (in comparison to women or people of other genders) who are feeling suicidal? |
2. What needs and barriers do health care providers experience when working with men (in comparison to women or people of other genders) who are feeling suicidal? conditions: Suicide Prevention conditions: Help-Seeking Behavior conditions: Men studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 586 type: ESTIMATED measure: STUDY 1: Help-seeking behavior measure: STUDY 1: Experienced need measure: STUDY 1: Emotional Openness measure: STUDY 1: Barriers measure: STUDY 1: Self-reliance measure: STUDY 1: Stigma measure: STUDY 1: needs of individuals with suicidal ideation measure: STUDY 2: needs of healthcare providers measure: STUDY 1: Socio-demographic characteristics measure: STUDY 1: Suicidality measure: STUDY 2: socio-demographic variables measure: STUDY 2: Professional experience with men with suicidal thoughts sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Flemish Centre of Expertise in Suicide Prevention, Ghent University status: RECRUITING city: Ghent zip: 9000 country: Belgium name: Eva De Jaegere, MSc role: CONTACT phone: +3293320775 email: [email protected] lat: 51.05 lon: 3.71667 hasResults: False |
<|newrecord|> nctId: NCT06375187 id: GC203 TIL-ST-Ⅰ briefTitle: Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL) for the Treatment of Advanced Malignant Solid Tumors acronym: KUNLUN-001 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-11-01 date: 2027-05-01 date: 2024-04-19 date: 2024-04-23 name: Shanghai Juncell Therapeutics class: INDUSTRY briefSummary: A clinical trial to assess the safety and efficacy of engineered Tumor Infiltrating Lymphocytes (TIL) for the treatment of Advanced Malignant Solid Tumors conditions: Solid Tumor conditions: Gynecologic Cancer conditions: Breast Cancer conditions: Gastrointestinal Cancer conditions: Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Engineering Tumor Infiltrating Lymphocytes measure: Maximal Tolerance Dose measure: Dose Limiting Toxicity measure: Adverse Events measure: Objective Response Rate measure: Duration of Response measure: Disease Control Rate measure: Progression-Free Survival measure: Overall Survival measure: Quality of Life Assessment sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375174 id: NSISTRCR_2202 briefTitle: PRECISE (PERFUSION IMAGING TO IDENTIFY POSTERIOR CIRCULATION CANDIDATES FOR THROMBECTOMY) acronym: SWISS-PRECISE overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-09 date: 2026-02-28 date: 2026-02-28 date: 2024-04-19 date: 2024-04-19 name: Dr. med. Carlo Cereda class: OTHER_GOV briefSummary: We hypothesize that patients with a favorable Critical Area Perfusion Score (CAPS≤3) on cerebral perfusion imaging will have a favorable response to revascularization by thrombectomy and that patients with a CAPS\>3 will not conditions: Posterior Circulation Acute Ischemic Stroke Due to Large Vessel Occlusion of the Vertebral or Basilar Artery Needing Endovascular Thrombectomy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Thrombectomy measure: mRS score sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Neurocenter of Southern Switzerland, Ospedale Civico city: Lugano state: Ticino zip: CH-6900 country: Switzerland lat: 46.01008 lon: 8.96004 hasResults: False |
<|newrecord|> nctId: NCT06375161 id: CD19-CN-A6 briefTitle: Anti-CD19-CAR-T Cells in Relapsed/Refractory B-cell Tumor Patients. overallStatus: RECRUITING date: 2023-12-11 date: 2025-12-10 date: 2039-12-10 date: 2024-04-19 date: 2024-04-19 name: Shanghai Tongji Hospital, Tongji University School of Medicine class: OTHER briefSummary: This study is a single-center, open-label, single-dose clinical trial of anti-CD19-CAR-T cell therapy in relapsed/refractory B-cell tumor patients after Qinglin pre-treatment. |
In this study phase, a traditional "3+3" trial design is employed for dose escalation. conditions: B Cell Malignancies studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: anti-CD19-CAR-T cells measure: Incidence of dose-limiting toxicity sex: ALL minimumAge: 18 Weeks maximumAge: 70 Weeks stdAges: CHILD facility: Shanghai Tongji Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200333 country: China name: Aibin Liang role: CONTACT phone: +8618601670600 email: [email protected] name: Ping LI role: CONTACT phone: +86 135 6418 1131 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06375148 id: Yan2024-0052 briefTitle: A Questionnaire Survey on Cognition of Enteral Nutrition Implementation in Patients Requiring Mechanical Ventilation in Prone Position overallStatus: ENROLLING_BY_INVITATION date: 2024-03-20 date: 2024-05-30 date: 2024-06-30 date: 2024-04-19 date: 2024-04-19 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: Prone ventilation is an important treatment for respiratory failure with intractable hypoxia, and the Corona Virus Disease 2019(COVID-19 ) outbreak has further elevated the status of prone ventilation. Early enteral nutrition (EN) is also recognised as an important measure to improve the prognosis of critically ill patients. However, the administration of enteral nutrition during prone position is still quite controversial. In this paper, we analysed the tolerance and safety of enteral nutrition in the prone position by reviewing studies before and after the COVID-19 outbreak. Key strategies to improve the tolerability of enteral nutrition in the prone position are also summarised and discussed. conditions: Enteral Nutrition conditions: Prone Position studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED name: Enteral nutrition measure: A questionnaire survey on cognition of enteral nutrition implementation in patients requiring mechanical ventilation in prone position sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Zhejiang University School of Medicine city: Zhenjiang country: China lat: 32.21086 lon: 119.45508 hasResults: False |
<|newrecord|> nctId: NCT06375135 id: R1MD017205 briefTitle: mHealth + e-Navigator Stepped Care on ART Adherence in Latino MSM acronym: Project STEP overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-03-31 date: 2027-03-31 date: 2024-04-19 date: 2024-04-19 name: Florida International University class: OTHER name: Ann & Robert H Lurie Children's Hospital of Chicago name: Care Resource Community Health Centers briefSummary: The goal of this study is to evaluate the efficacy of stepped care strategies to improve ART adherence among adult Latino MSM with HIV using a sequential, multiple assignment, randomized trial (SMART). The trial will compare a stepped care strategy of delivering TXTXT ("Treatment Text") first and stepping up to remote patient navigation for non-responders vs. a stepped care strategy of delivering TXTXT + e-Navigation first and stepping up to EMA-supported e-Navigation for non-responders. Both TXTXT and the foundations of the e-Navigation interventions are CDC evidence-based interventions (EBI). We propose to use a SMART design which explicitly allows building, testing, and optimizing stepped care strategies without compromising rigor or randomization. We propose three specific aims: |
Aim 1. Compare the immediate (6-month) and sustained (9- and 12-month) efficacy of two static (non-stepped) treatment regimens (TXTXT alone vs. TXTXT + e-Navigation) on ART adherence and viral suppression among Latino MSM with HIV. Hypothesis 1a. TXTXT + e-Navigation will be more efficacious than TXTXT alone. Aim 2. Compare the immediate (6-month) and sustained (9- and 12-month) efficacy of two stepped care strategies (TXTXT with added e-Navigation for non-responders vs. TXTXT + e-Navigation with added EMA support for non-responders) on ART adherence and viral suppression among Latino MSM with HIV. Hypothesis 2a: TXTXT + e-Navigation with added EMA support for non-responders at the 3-month follow-up will be more efficacious than TXTXT with added e-Navigation for non-responders at the 3-month follow-up. Aim 3. Identify baseline and time-varying moderators on the association between stepped care strategy and ART adherence and viral suppression among Latino MSM with HIV. Hypotheses 3a-c: TXTXT with added e-Navigation for non-responders will be less efficacious than TXTXT + e-Navigation with added EMA support for non-responders for individuals who are: (a) older at baseline, or report (b) substance use, or (c) symptoms of depression between baseline and the 3-month follow-up. conditions: ART Adherence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: We will enroll 250 adults Latino MSM with HIV with suboptimal ART adherence and randomize (1:1) into two arms: TXTXT (n=125) or TXTXT + e-Navigation (n=125). Those in Arm 1 who continue to have suboptimal adherence (\<90% pills taken) at 3-months will be re-randomized (1:1) to continue TXTXT or add e-Navigation; those in Arm 2 who have suboptimal adherence will be re-randomized (1:1) to continue TXTXT + e-Navigation or add EMA support. At 6-months, the intervention arms will cease to receive any intervention components and be followed for an additional 6-months. primaryPurpose: TREATMENT masking: NONE count: 250 type: ESTIMATED name: TXTXT name: e-Navigation name: Ecological Momentary Assessment (EMA) supported e-Navigation. measure: ART adherence measure: HIV viral load sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Care Resource Community Health Centers, Inc., d/b/a CARE RESOURCE city: Miami state: Florida zip: 331370000 country: United States name: Sheryl J Zayas, MD role: CONTACT phone: 305-576-1234 email: [email protected] name: Sheryl J Zayas, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 hasResults: False |
<|newrecord|> nctId: NCT06375122 id: 10001951 id: 001951-C briefTitle: Natural History Study of Kaposi Sarcoma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2034-12-31 date: 2036-12-31 date: 2024-04-19 date: 2024-04-26 name: National Cancer Institute (NCI) class: NIH briefSummary: Background: |
Kaposi sarcoma (KS) is a type of tumor caused by the Kaposi sarcoma herpesvirus. KS usually affects the skin, but lesions can also appear in the lymph nodes, lungs and digestive tract. KS is most common in people with compromised immunity, but it also appears in otherwise healthy people. Researchers want to understand more about how KS develops, why it may recur, and how it affects the immune system and organs. |
Objective: |
To learn more about the natural history of KS. |
Eligibility: |
People aged 18 years and older with KS. |
Design: |
Participants will be screened. They will have a physical exam with blood tests. They will have an imaging scan. They may need a new biopsy: Tissue samples may be cut from their tumor. Their ability to perform normal activities will be assessed. |
Participants will visit the clinic to have their KS evaluated. In addition to the imaging scans and other tests performed during screening, procedures may include: |
Eye exam. |
Ultrasound exam of the heart (electrocardiogram). |
Collection of saliva and urine samples. |
Biopsies of the skin or lymph nodes. |
Swabs of the anus and cervix. |
Photographs of skin lesions. |
Removal of fluid samples from the space around the lungs, intestine, or heart. |
The evaluation visit will be repeated 5 more times over 18 months and then yearly for up to 10 years. |
Participants will follow their standard treatment for KS during the study. conditions: Kaposi Sarcoma conditions: HIV studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED measure: To characterize the natural history of KS, including presentation, manifestation, and proportion of participants with KS with remission and recurrence by epidemiologic subtype measure: To evaluate differences in rates of KS recurrence by HIV status and CD4 T cell count measure: To evaluate the emergence of KSHV-associated inflammatory syndromes in the natural history of KS sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institutes of Health Clinical Center city: Bethesda state: Maryland zip: 20892 country: United States name: National Cancer Institute Referral Office role: CONTACT phone: 888-624-1937 email: [email protected] lat: 38.98067 lon: -77.10026 hasResults: False |
<|newrecord|> nctId: NCT06375109 id: BJXK-2023-KY-53 id: NeoSCLC-001 type: OTHER domain: Beijing Chest Hospital, Capital Medical University briefTitle: PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage SCLC acronym: NeoSCLC-001 overallStatus: NOT_YET_RECRUITING date: 2024-04-16 date: 2027-04-15 date: 2029-04-15 date: 2024-04-19 date: 2024-04-19 name: Beijing Chest Hospital, Capital Medical University class: OTHER briefSummary: This is an open-label, non-randomized, controlled, single-center, phase II study to compare the efficacy and safety of neoadjuvant PD-L1/PD-1 inhibitor + chemotherapy (carboplatin/cisplatin + etoposide) with chemotherapy (carboplatin/cisplatin + etoposide) alone followed by radical surgery and adjuvant treatment as perioperative therapy in patients with limited-stage SCLC. conditions: Limited-stage Small-cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Tislelizumab name: Carboplatin injection name: Cisplatin injection name: Etoposide injection measure: Pathologic Complete Response (pCR) Rate measure: Major Pathologic Response (MPR) Rate measure: Event-Free Survival (EFS) measure: Overall Survival (OS) measure: Objective response rate (ORR) measure: Safety: frequency of severe adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375096 id: Graves' disease briefTitle: Bone Mineral Density in Children With Graves' Disease overallStatus: NOT_YET_RECRUITING date: 2024-06-25 date: 2025-06-25 date: 2025-06-25 date: 2024-04-19 date: 2024-04-19 name: Assiut University class: OTHER briefSummary: to evaluate bone mineral density in children with graves' disease conditions: Bone Density, Low conditions: Bone Mineral Density in Children With Graves' Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: evaluate bone mineral density measure: bone mineral density sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06375083 id: 23-1231 briefTitle: Computerized Cognitive Behavioral Therapies for Suicide Prevention and Depression overallStatus: RECRUITING date: 2024-03-20 date: 2024-12-30 date: 2024-12-30 date: 2024-04-19 date: 2024-04-19 name: VA Eastern Colorado Health Care System class: FED briefSummary: This study plans to learn more about the use of one of two self-guided online cognitive behavioral therapy courses. One is focused on symptoms of depression and one is focused on history of suicidal thoughts and behaviors. conditions: Suicide conditions: Depression studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Cognitive Behavioral Therapy for Suicide Prevention (cCBT-SP) and Cognitive Behavioral Therapy for Depression (cCBT-D) primaryPurpose: TREATMENT masking: NONE count: 472 type: ESTIMATED name: Cognitive Behavioral Therapy measure: Client Satisfaction Questionnaire measure: Internet Evaluation and Utility Questionnaire measure: Internet Impact and Effectiveness Questionnaire measure: Narrative Evaluation of Intervention Interview measure: Recruitment Rate measure: Completion of intervention measure: Beck Scale for Suicide Ideation measure: Patient Health Questionnaire-9 measure: Posttraumatic Stress Disorder Checklist-5 measure: Generalized Anxiety Disorder-7 measure: Computerized Adaptive Testing - Suicide Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eastern Colorado Health Care System status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Lisa A Brenner, PhD role: CONTACT phone: 720-723-6488 email: [email protected] name: Kelly A Stearns-Yoder, MA role: CONTACT phone: 720-723-6477 email: [email protected] lat: 39.72943 lon: -104.83192 hasResults: False |
<|newrecord|> nctId: NCT06375070 id: RMeng1 briefTitle: Anticoagulants for PFO Patients overallStatus: COMPLETED date: 2016-08 date: 2022-08 date: 2022-08 date: 2024-04-19 date: 2024-04-19 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: Patients who underwent both bubble transcranial Doppler (bubble-TCD) and transoesophageal echocardiography (TEE) at our institution were consecutively enrolled in this real-world case-control study from August 2016 through August 2023. The patients were categorized into three groups based on the degree of the shunt observed: mild (3-9 bubbles), moderate (10-30bubbles), and severe (more than 30 bubbles). In cases with mild-shunt (small-size) PFO, post-procedural anticoagulation or PFO closure was administered. Subsequent to the interventions, the follow-up encompassed the recording of migraine remission, recurrent neurological incidents, instances of major bleeding, and mortality. conditions: Patent Foramen Ovale studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 277 type: ACTUAL name: PFO closure name: anticoagulant measure: whether occur recurrent stroke or migraine relief sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375057 id: asiamkfv49wurfpylld2m6g7cr4kz6 briefTitle: Relationship Between Acute Phase Markers and Post-operative Pain in Laparoscopic Cholecystectomy: An Observational Study overallStatus: RECRUITING date: 2023-03-03 date: 2024-02-26 date: 2025-12-31 date: 2024-04-19 date: 2024-04-19 name: University of Roma La Sapienza class: OTHER briefSummary: Many patients undergoing laparoscopic cholecystectomy are prone to developing acute and chronic post-operative pain. |
The aim of the study is to show a possible correlation between pain and acute phase proteins in order to: |
* predict the severity of pain; |
* select most suitable pain relief therapy for the patient. conditions: Post Operative Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 54 type: ESTIMATED name: laparoscopic cholecystectomy measure: Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Laparoscopic Cholecystectomy measure: Relationship Between Post-operative Pain and D-dimer in Laparoscopic Cholecystectomy measure: Relationship Between Post-operative Pain and Fibrinogen in Laparoscopic Cholecystectomy measure: Relationship Between Post-operative Pain and white blood cell count in Laparoscopic Cholecystectomy measure: Relationship Between Post-operative Pain and Neutrophil to Lymphocyte Ratio (NLR) in Laparoscopic Cholecystectomy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Augusto Lauro status: RECRUITING city: Roma zip: 000186 country: Italy name: Augusto Lauro role: CONTACT phone: +39 388 8663 879 email: [email protected] lat: 41.89193 lon: 12.51133 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-03-03 uploadDate: 2024-04-16T07:17 filename: Prot_SAP_000.pdf size: 179155 hasResults: False |
<|newrecord|> nctId: NCT06375044 id: SIM0500-101 briefTitle: Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2026-06-30 date: 2028-12-30 date: 2024-04-19 date: 2024-04-19 name: Jiangsu Simcere Pharmaceutical Co., Ltd. class: INDUSTRY name: Shanghai Xianxiang Medical Technology Co., Ltd. briefSummary: This is an open-label, multicenter phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0500 in adult participants with Relapsed or Refractory Multiple Myeloma(RRMM). The trial is consisted of two parts, Part 1 (dose escalation) and Part 2 (dose optimization). In both parts, SIM0500 will be administered until disease progression, intolerable toxicity, withdraw of consent or end of trial. conditions: Relapsed or Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: SIM0500 measure: Dose-limiting toxicity (DLT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences city: Tianjin state: Tianjin zip: 300000 country: China name: Yan Xu role: CONTACT email: [email protected] lat: 39.14222 lon: 117.17667 hasResults: False |
<|newrecord|> nctId: NCT06375031 id: HR011408-103 briefTitle: Comparison of HR011408 and NovoRapid® in Subjects With Diabetics overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07-01 date: 2024-07-15 date: 2024-04-19 date: 2024-04-19 name: Jiangsu HengRui Medicine Co., Ltd. class: INDUSTRY briefSummary: The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in Subjects with Diabetics. conditions: Diabetes studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study was designed as a multi-center, randomized, double-blind, three-cycle crossover, positive drug control (NovoRapid ®) To compare the pharmacokinetics, pharmacodynamics, safety, and tolerability of a single injection of HR011408 or NovoRapid ® before or after a standard meal test in patients with type 1 or type 2 diabetes. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: HR011408 injection; HR011408 injection Placebo name: NovoRapid®; HR011408 injection Placebo name: HR011408 injection Placebo; HR011408 injection measure: Area under the serum concentration-time curve of insulin aspart measure: Area under the serum concentration-time curve of insulin aspart measure: Plasma glucose concentration measure: Number of subjects with adverse events and severity of adverse events sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: The Second Hospital of Anhui Medical University city: Hefei state: Anhui zip: 230601 country: China name: 230601 Pan, Doctor role: CONTACT phone: 0551-65997421 email: [email protected] name: Wei Hu, Doctor role: CONTACT phone: 0551-65997421 email: [email protected] lat: 31.86389 lon: 117.28083 hasResults: False |
<|newrecord|> nctId: NCT06375018 id: OST1_011 briefTitle: Effect of the Diaphragm Stretching Technique on Nonspecific Low Back Pain overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-19 date: 2024-04-19 name: Escola Superior de Tecnologia da Saúde do Porto class: OTHER briefSummary: This study aims to analyze the efficacy of diaphragm stretching technique on symptomatology in young adults with nonspecific low back pain. conditions: Nonspecific Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Placebo Technique name: Diaphragm Stretching measure: Change in level of inspiratory capacity immediately after intervention measure: Change in the level of disability derived from low back pain immediately after the intervention measure: Change in the level of functionality of the lumbar spine immediately after the intervention sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Escola Superior de Saúde do Porto city: Porto zip: 4200-072 country: Portugal lat: 41.14961 lon: -8.61099 hasResults: False |
<|newrecord|> nctId: NCT06375005 id: 2024-0381 briefTitle: Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-08-01 date: 2026-12-31 date: 2024-04-19 date: 2024-04-19 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: This study is a prospective, open-label, randomized, controlled, multi-center clinical trial. The aim of this study is to investigate the efficacy and safety of Telitacicept in adults with early diffuse cutaneous systemic sclerosis (dcSSc), with Mycophenolate Mofetil (MMF) administered as a background treatment. conditions: Diffuse Cutaneous Systemic Sclerosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 38 type: ESTIMATED name: Telitacicept name: Mycophenolate Mofetil measure: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 48 measure: Percentage of Participants With Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 measure: Percentage of Participants Who Improved in Modified Rodnan Skin Score (mRSS) by ≥20%, ≥40%, ≥60% From Baseline to Week 24 and Week 48 measure: American College of Rheumatology Composite Response Index for Systemic Sclerosis (ACR-CRISS) and Revised ACR-CRISS at Week 24 and 48 measure: Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted at Week 24 and Week 48 measure: Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Percent Predicted (Corrected For Hemoglobin) at Week 24 and Week 48 measure: Change From Baseline in Patient's Global Assessment at Week 24 and Week 48 measure: Change From Baseline in Physician's Global Assessment at Week 24 and Week 48 measure: Change From Baseline in Short Form-36 (SF-36) Questionnaire at Week 24 and Week 48 measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24 and Week 48 measure: Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI) at Week 24 and Week 48 measure: Change From Baseline in Tender Joint Counts at Week 24 and Week 48 measure: Change From Baseline in Swollen Joint Counts at Week 24 and Week 48 measure: Change From Baseline in Digital Ulcer Counts at Week 24 and Week 48 sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Hospital of Yangzhou University city: Yangzhou state: Jiangsu zip: 225009 country: China lat: 32.39722 lon: 119.43583 facility: Huashan Hospital of Fudan University city: Shanghai state: Shanghai zip: 200433 country: China lat: 31.22222 lon: 121.45806 facility: Hangzhou First People's Hospital city: Hangzhou state: Zhejiang zip: 310006 country: China lat: 30.29365 lon: 120.16142 facility: Sir Run Run Shaw Hospital, Zhejiang University School Of Medicine city: Hangzhou state: Zhejiang zip: 310016 country: China lat: 30.29365 lon: 120.16142 facility: The Second Affiliated Hospital of Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310016 country: China name: Jing Xue, PhD role: CONTACT phone: 86-13858121751 email: [email protected] lat: 30.29365 lon: 120.16142 facility: Changxing People's Hospital city: Huzhou state: Zhejiang zip: 313100 country: China lat: 30.8703 lon: 120.0933 facility: The First Hospital of Jiaxing city: Jiaxing state: Zhejiang zip: 314000 country: China lat: 30.7522 lon: 120.75 facility: Ningbo First Hospital city: Ningbo state: Zhejiang zip: 315000 country: China lat: 29.87819 lon: 121.54945 facility: The First Affiliated Hospital of Wenzhou Medical University city: Wenzhou state: Zhejiang zip: 325000 country: China lat: 27.99942 lon: 120.66682 hasResults: False |
<|newrecord|> nctId: NCT06374992 id: Pro00114569 briefTitle: Family Involvement Hospital Ethnography overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2024-08 date: 2024-04-19 date: 2024-04-19 name: Duke University class: OTHER briefSummary: The goal of this observational study is to learn about the role of family members in caring for hospitalized older adults with cognitive impairment. The main questions it aims to answer are: |
1. What features of the healthcare system facilitate or hinder family involvement in care from the perspective of patients, families, and healthcare workers? |
2. How do hospital leaders understand the facilitators and barriers to family involvement? |
Data collection will occur via semi-structure interviews, direct observation, and artifact analysis. conditions: Dementia studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED measure: Faciltators and Barriers to Family Involvement in Care of Hospitalized Older Adults with Cognitive Impairment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06374979 id: 2024-0047 briefTitle: Efficacy and Safety of Ixekizumab in Patients With Refractory Guttate Psoriasis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2025-06 date: 2024-04-19 date: 2024-04-19 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: The goal of this clinical trial is to analyse efficacy and safety of ixekizumab in participants with refractory guttate psoriasis. The main question it aims to answer is: |
What percentage of participants achieved more than 90% reduction from baseline in Psoriasis Area Index （PASI 90） after 12 weeks of ixekizumab treatment? Participants will receive a 12-week treatment of ixekizumab, with follow-up visits every 2 weeks during the treatment period. Keep a diary of their symptoms and Psoriasis Area Index. conditions: Guttate Psoriasis studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Ixekizumab measure: PASI 90 response measure: PGA 0/1 response measure: PASI 100 response measure: Relapse sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06374966 id: 2024-0246 briefTitle: Real-world Study of Efficacy and Safety of Zonisamide in add-on Therapy for Patients With Focal Epilepsy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-09 date: 2025-12 date: 2024-04-19 date: 2024-04-19 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER name: Hangzhou Children's Hospital name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine name: Jinhua Second Hospital name: Ningbo Medical Center Lihuili Hospital name: Ningbo Women & Children's Hospital name: Yuyao People's Hospital name: Huzhou Third People's Hospital name: The Second Affiliated Hospital of Jiaxing University name: Lishui Country People's Hospital briefSummary: Patients were first observed for a 4-week baseline period, which required no medication adjustments and a seizure frequency of greater than or equal to 2 times per 4-week . After the baseline observation period, if the patients met the criteria for enrolment and there were no contraindications, zonisamide was added as an additional therapeutic drug.Clinical data were collected before the initiation of treatment, at 1 month, 3 months and 6 months after taking zonisamide respectively, with regular review of blood tests and urinary ultrasound, and imaging and electrophysiological examinations according to the clinical needs of the patient's actual condition. conditions: Epilepsies, Partial studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Zonisamide measure: Effective rate at 6 months of treatment measure: Effective rate at 3 months of treatment measure: Total time to treatment failure measure: Incidence of side effects sex: ALL minimumAge: 2 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hangzhou Children's Hospital city: Hangzhou state: Zhejiang zip: 310005 country: China name: Zhanli Liu, doctorate role: CONTACT phone: 15968194368 email: [email protected] lat: 30.29365 lon: 120.16142 facility: The Second Affiliated Hospital of Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310009 country: China name: Shuang Wang, doctorate role: CONTACT phone: 13588817561 email: [email protected] lat: 30.29365 lon: 120.16142 facility: Huzhou Third People's Hospital city: Huzhou state: Zhejiang zip: 313002 country: China name: Changguo Zhang, doctorate role: CONTACT phone: 15957288075 email: [email protected] lat: 30.8703 lon: 120.0933 facility: Jiaxing Second hospital city: Jiaxing state: Zhejiang zip: 314099 country: China name: Xiaoxiang Yu, doctorate role: CONTACT phone: 13567340650 email: [email protected] lat: 30.7522 lon: 120.75 facility: Jinhua Second hospital city: Jinhua state: Zhejiang zip: 321016 country: China name: Suhong Ye, doctorate role: CONTACT phone: 13757990511 email: [email protected] lat: 29.10678 lon: 119.64421 facility: The Fourth Affilicated Hospital of Zhejiang University School of Medicine city: Jinhua state: Zhejiang zip: 322099 country: China name: Jiajia Fang, doctorate role: CONTACT phone: 15215880868 email: [email protected] lat: 29.10678 lon: 119.64421 facility: Lishui People's Hospital city: Lishui state: Zhejiang zip: 323050 country: China name: Likang Lan, doctorate role: CONTACT phone: 18957090351 email: [email protected] lat: 28.46042 lon: 119.91029 facility: Ningbo Women And Children's Hospital city: Ningbo state: Zhejiang zip: 315012 country: China name: Minghai Huang, doctorate role: CONTACT phone: 13605742462 email: [email protected] lat: 29.87819 lon: 121.54945 facility: Ningbo Medical center Lihuili hospital city: Ningbo state: Zhejiang zip: 315048 country: China name: Xiaoqin Fan, doctorate role: CONTACT phone: 13685739576 email: [email protected] lat: 29.87819 lon: 121.54945 facility: Yuyao People's hospital city: Yuyao state: Zhejiang zip: 315499 country: China lat: 30.05 lon: 121.14944 hasResults: False |
<|newrecord|> nctId: NCT06374953 id: 2024-0182 briefTitle: A Novel Viscoelastic Test Based on Ultrasonic Guided Wave for Identifying Hyperfibrinolysis Rapidly overallStatus: RECRUITING date: 2024-03-26 date: 2024-09-30 date: 2024-09-30 date: 2024-04-19 date: 2024-04-19 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: This study compares the results of the existing fibrinolysis monitoring technology to the Ultrasound-based viscoelastic hemostasis analysis, a new method, using small amount of extra blood obtained during routine blood draws in surgery patients. conditions: Hyperfibrinolysis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 140 type: ESTIMATED name: Ultrasound-based viscoelastic hemostasis analysis measure: Comparison of the novel viscoelastic hemostasis analysis results to TEG-LY30 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Zhejiang University anesthesiology department status: RECRUITING city: Hangzhou state: Zhejiang zip: 310009 country: China name: Fengjiang ZHANG role: CONTACT phone: +8613858007629 email: [email protected] lat: 30.29365 lon: 120.16142 hasResults: False |
<|newrecord|> nctId: NCT06374940 id: Lütfi Kırdar City Hospital briefTitle: Surgical Outcomes of Conventional Hysterectomy or Manipulator-assisted Abdominal Hysterectomy overallStatus: ENROLLING_BY_INVITATION date: 2024-04-17 date: 2024-05-17 date: 2024-05-18 date: 2024-04-19 date: 2024-04-19 name: Dr. Lutfi Kirdar Kartal Training and Research Hospital class: OTHER_GOV briefSummary: Objective: The comparison of surgical outcomes conventional hysterectomy and manipulator-assisted hysterectomy |
Study design: Prospective randomized controlled trial. Allocation to either group occurred via computer-generated random numbers. Sequentially numbered, opaque envelopes were prepared according to randomization. The patients were unaware of whether they would undergo a conventional hysterectomy or manipulator-assisted abdominal hysterectomy for their surgical procedure. The research coordinator unveiled group assignments upon individual patient recruitment by opening the corresponding envelope. |
Study population: Inclusion criteria were patients aged 40-70 years who underwent hysterectomy for benign gynecological indications. |
Primary outcomes: (1) Operation Time. |
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