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<|newrecord|> nctId: NCT06282653 id: Endo-ergonomics briefTitle: Postural and Muscle Fatigue Analysis of Endodontic Residents overallStatus: RECRUITING date: 2024-04-30 date: 2025-06-30 date: 2025-11-01 date: 2024-02-28 date: 2024-02-28 name: Universidad Europea de Madrid class: OTHER briefSummary: Musculoskeletal disorders (MSDs) are a significant occupational health problem for dentists and have been linked to a decline in quality of life, often leading to stress-related illnesses and early retirement. Poor posture, poor movement or imbalances in the neck or shoulders can lead to the three most common pain syndromes in dentistry. The objectives of this study were to evaluate the working position adopted during an endodontic procedure and to determine the perception of symptoms of musculoskeletal disorders in first and second year students of the Master in Advanced Endodontics at the European University of Madrid (UEM), using the standardised Nordic Kuorinka questionnaire supplemented by a form with socio-demographic variables. This study has a descriptive cross-sectional observational design and included 10 students selected by convenience sampling. A video camera was used to record the procedures from three different angles for a maximum of 5 minutes. The information was processed using Microsoft Excel spreadsheet software, and the video recordings were assessed using Rodgers' Muscular Fatigue Analysis (RMFA) and Rapid Upper Limb Assessment (RULA). conditions: Musculoskeletal System Disease conditions: Position Sense Disorders conditions: Symptoms and Signs conditions: Postural; Defect conditions: Endodontic Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 10 type: ESTIMATED measure: Symptom Perception sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Universidad Europea de Madrid status: RECRUITING city: Villaviciosa De Odón state: Madrid country: Spain name: Antonio Conde, PhD role: CONTACT lat: 40.35692 lon: -3.90011 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-02-20 uploadDate: 2024-02-20T05:22 filename: Prot_000.pdf size: 96217 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-20 uploadDate: 2024-02-20T05:30 filename: ICF_001.pdf size: 77805 hasResults: False |
<|newrecord|> nctId: NCT06282640 id: 567 briefTitle: Comparıson Of Electromyography Results Before And After Vıtamın D Treatment In Patıents Wıth Carpal Tunnel Syndrome overallStatus: COMPLETED date: 2021-12-30 date: 2022-06-30 date: 2022-08-30 date: 2024-02-28 date: 2024-02-28 name: Dr. Ayşe Güç class: OTHER_GOV name: Kayseri City Hospital briefSummary: Therefore, we aimed to evaluate the effectiveness of vitamin D replacement therapy on pain, electrophysiological parameters, ultrasonographic measurement results and functional status scales in CTS patients with low serum vitamin D levels. conditions: Carpal Tunnel Syndrome conditions: Vitamin D Deficiency studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 87 type: ACTUAL name: Vitamin D measure: electrophysiological scale. measure: monofilament test measure: Boston symptom severity scale sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kayseri City Hospital city: Kayseri country: Turkey lat: 38.73222 lon: 35.48528 hasResults: False |
<|newrecord|> nctId: NCT06282627 id: 10430012010023 briefTitle: The COVID HOME Study: Prospective Cohort Study of Non-hospitalised COVID-19 Patients acronym: COVID-HOME overallStatus: COMPLETED date: 2020-03-20 date: 2022-07-30 date: 2022-08-30 date: 2024-02-28 date: 2024-02-28 name: University Medical Center Groningen class: OTHER name: ZonMw: The Netherlands Organisation for Health Research and Development briefSummary: Background. Guidelines on COVID-19 management are developed as we learn from this pandemic. However, most research has been done on hospitalised patients and the impact of the disease on non-hospitalised and their role in transmission are not yet well understood. |
The COVID HOME study conducts research among COVID-19 patients and their family members who were not hospitalised during acute disease, to guide patient care and inform public health guidelines for infection prevention and control in the community and household. |
Methods. An ongoing prospective longitudinal observational study of COVID-19 outpatients was established in March 2020 at the beginning of the COVID-19 pandemic in the Netherlands. Laboratory confirmed SARS-CoV-2 infected individuals of all ages that did not merit hospitalisation, and their household (HH) members, were enrolled after written informed consent. Enrolled participants were visited at home within 48 hours after initial diagnosis, and then weekly on days 7, 14 and 21 to obtain clinical data, a blood sample for biochemical parameters/cytokines and serological determination; and a nasopharyngeal/throat swab plus urine, stool and sperm or vaginal secretion (if consenting) to test for SARS-CoV-2 by RT-PCR (viral shedding) and for viral culturing. Weekly nasopharyngeal/throat swabs and stool samples, plus a blood sample on days 0 and 21 were also taken from HH members to determine whether and when they became infected. All participants were invited to continue follow-up at 3-, 6-, 12- and 18-months post-infection to assess long-term sequelae and immunological status. conditions: COVID-19 conditions: Post-COVID-19 Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 256 type: ACTUAL name: Observational study measure: SARS-CoV-2 infection measure: Long-term sequelae sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Groningen city: Groningen zip: 9713 GZ country: Netherlands lat: 53.21917 lon: 6.56667 hasResults: False |
<|newrecord|> nctId: NCT06282614 id: MUCO245 id: 2023-A02081-44 type: OTHER domain: ID-RCB briefTitle: Performance and Safety of MUCOGYNE® Ovule as a Moisturizer acronym: MOVHYDA overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2025-01 date: 2024-02-28 date: 2024-02-28 name: Biocodex class: INDUSTRY name: Voisin Consulting Life Science (VCLS) briefSummary: The aim of this post-Market Clinical Follow-up (PMCF) study is to confirm the efficacy and safety of MUCOGYNE® Ovule in the maintainance of natural moisture of the vulvovaginal mucosa and in the compensation for any natural secretions deficiencies, when used in accordance with its approved labeling, in the context of vulvovaginal dryness. conditions: Vaginal Dryness studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, multicenter (France), open label without comparator study primaryPurpose: OTHER masking: NONE count: 50 type: ESTIMATED name: Mucogyne Ovule measure: Assessment of the efficacy of MUCOGYNE® Ovule intra vaginal applications on subjects' vaginal dryness irrespective of the cause over a 35-day period of use measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing vulva irritation measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing vulvo-vaginal discomfort measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing itching measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing pain and/or dyspareunia related to vaginal dryness measure: Assessment of the patient's sexual function measure: Assessment of the patient's satisfaction measure: Assessment of changes in patient's clinical status measure: Assessment by investigator of changes in patient's clinical status measure: Assessment of the safety of MUCOGYNE® Ovule measure: Assessment of the device deficiencies of MUCOGYNE® Ovule measure: Assessment of the usability of MUCOGYNE® Ovule sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: JEAN Christian's medical office city: Nogent-sur-Marne zip: 94130 country: France lat: 48.83333 lon: 2.48333 facility: Dr Ramez GHADRI's medical office city: Orléans zip: 45100 country: France name: Ramez GHADRI, MD role: CONTACT name: Ramez GHADRI, MD role: PRINCIPAL_INVESTIGATOR lat: 47.90289 lon: 1.90389 facility: Dr Raïssa APERANO-MAS's medical office city: Rennes zip: 35000 country: France name: Raïssa APERANO-MAS, MD role: CONTACT name: Raïssa APERANO-MAS, MD role: PRINCIPAL_INVESTIGATOR lat: 48.11198 lon: -1.67429 hasResults: False |
<|newrecord|> nctId: NCT06282601 id: GUIGOU - Defaye 2023 briefTitle: STUDY OF THE EFFECT OF RHYTHMIC AND NON-RHYTHMIC MUSICAL PRIMING ON THE SYNTAX CAPACITY OF PRESBYACOUSTIC OLDER ADULTS acronym: AMORCAGE MUSIC overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-03 date: 2024-03 date: 2024-02-28 date: 2024-02-28 name: Centre Hospitalier Universitaire Dijon class: OTHER briefSummary: Presbyacusis, or age-related hearing loss, is a public health problem, affecting 20% of men and 30% of women over the age of 70 according to the WHO. In the most incapacitating cases, hearing aids are required. Numerous studies have evaluated the benefits of hearing aids, particularly in terms of improved hearing and quality of life. |
However, the specific effect of music on language skills has not yet been studied in hearing-impaired older adults. |
In this context, it was decided to study the effect of musical priming on the syntactic abilities of adults aged 70 or older with presbyacusis. |
This study is based on the hypothesis that music priming with regular music optimizes the syntax language skills of people with presbyacusis, as has already been proven in adults and normal-hearing children. conditions: Presbyacousie studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 27 type: ESTIMATED name: Audiogram name: Musical priming for the syntax test name: Test MMSE name: Barcelona Music Reward Questionnaire measure: linguistic performance test focusing on syntax. sex: ALL minimumAge: 70 Years stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06282588 id: CTO21042GZA briefTitle: Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers acronym: THUNDER overallStatus: RECRUITING date: 2023-12-13 date: 2030-07-31 date: 2030-12-31 date: 2024-02-28 date: 2024-02-28 name: Cancer Research Antwerp class: OTHER name: Bayer name: Veracyte, Inc. briefSummary: This Investigator-initiated, Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER) study will be conducted in subjects with high-risk localized or locally advanced prostate cancer (PCa). The study contains both a randomized Phase 3 treatment intensification study, as well as a treatment de-intensification non-randomized Phase 2 study. The aim of the THUNDER study is to improve the outcome of high-risk PCa by improved risk stratification. Novel radiotracers and a genomic classifier (Decipher) will be used to guide treatment decisions, instead of standard imaging which is limited by lower sensitivity and specificity. |
The hypothesis for the study is that treatment intensification based on a positive PSMA PET/ CT scan or Decipher high score (\> 0.6) improves time to new metastases detected on PSMA PET/ CT in high-risk PCa. In patients who are PSMA PET/ CT negative with a low/ intermediate Decipher score (≤ 0.6), it is hypothesized that treatment de-intensification will improve patient quality of life while maintaining a good oncological outcome. |
The study will be conducted at multiple centers across Europe. Participation in the study will comprise a screening period, where the screening assessments must be completed before subjects are enrolled and randomized (only for Phase 3 subjects). Eligible, consenting subjects will then undergo treatment according to their assigned study phase and treatment group, to occur over up to 96 weeks (24 months) with a post-treatment follow-up period to monitor safety and efficacy. The study will be closed when 96 events have been registered for the primary endpoint, which is expected to be at 7-8 years from the time of randomization of the first subject. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase 2: non randomised, 1 treatment arm, open label Phase 3: randomized 1:1 between two treatment arms, blinded primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Phase 3 trial: blinded Phase 2 trial: open label whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 493 type: ESTIMATED name: Darolutamide name: Darolutamide matched placebo name: Radiotherapy name: Zoladex 3.6Mg Implant name: Zoladex LA name: Decapeptyl sustained release 22.5 mg name: Decapeptyl sustained release 11.25 mg name: Depo-Eligard 45 mg name: Depo-Eligard 22.5 mg name: Depo-Eligard 7.5 mg name: Firmagon 120 MG Injection name: Firmagon 80 MG Injection name: Docetaxel measure: Phase 3: PSMA PET metastasis free survival (ppMFS) measure: Phase 2: quality of life (sexual subdomain) measure: Phase 2: quality of life (hormonal subdomain) measure: Overall survival measure: Prostate-cancer specific survival measure: Biochemical progression-free survival measure: Time to next systemic therapy measure: Frequency and severity of adverse events sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GZA Sint-Augustinus status: RECRUITING city: Wilrijk state: Antwerp zip: 2610 country: Belgium name: Piet Ost, MD, PhD role: CONTACT email: cancertrials@gza.be name: Piet Ost role: PRINCIPAL_INVESTIGATOR lat: 51.16734 lon: 4.39513 facility: OLVZ Aalst status: NOT_YET_RECRUITING city: Aalst zip: 9300 country: Belgium name: Samuel Br role: CONTACT name: Samuel Bral role: PRINCIPAL_INVESTIGATOR lat: 50.93604 lon: 4.0355 facility: AZ Sint-Jan status: NOT_YET_RECRUITING city: Brugge zip: 8000 country: Belgium name: Sabine Meersschout role: CONTACT name: Sabine Meersschout role: PRINCIPAL_INVESTIGATOR lat: 51.20892 lon: 3.22424 facility: Saint Luc status: NOT_YET_RECRUITING city: Bruxelles zip: 1200 country: Belgium name: Ad Vanderm role: CONTACT name: Ad Vandermeulen role: PRINCIPAL_INVESTIGATOR lat: 50.85045 lon: 4.34878 facility: UZA status: NOT_YET_RECRUITING city: Edegem zip: 2600 country: Belgium name: Karen Fransis role: CONTACT name: Karen Fran role: PRINCIPAL_INVESTIGATOR lat: 51.15662 lon: 4.44504 facility: UZ Gent status: NOT_YET_RECRUITING city: Gent zip: 9000 country: Belgium name: Valérie Fonteyne role: CONTACT name: Valérie Fonteyne role: PRINCIPAL_INVESTIGATOR lat: 51.05 lon: 3.71667 facility: AZ Sint-Lucas status: NOT_YET_RECRUITING city: Gent zip: 900 country: Belgium name: Lien Van De Voorde role: CONTACT name: Lien Van De Voor role: PRINCIPAL_INVESTIGATOR lat: 51.05 lon: 3.71667 facility: AZ Groeninge status: NOT_YET_RECRUITING city: Kortrijk zip: 8500 country: Belgium name: Nick Liefhooghe role: CONTACT name: Nick Liefhooghe role: PRINCIPAL_INVESTIGATOR lat: 50.82803 lon: 3.26487 facility: CHU Liège status: NOT_YET_RECRUITING city: Liège zip: 4000 country: Belgium name: Brieuc Suatois role: CONTACT name: Brieuc Sautois role: PRINCIPAL_INVESTIGATOR lat: 50.63373 lon: 5.56749 facility: AZ Delta status: NOT_YET_RECRUITING city: Roeselare zip: 8800 country: Belgium name: Benedikt Engels role: CONTACT name: Benedikt Enge role: PRINCIPAL_INVESTIGATOR lat: 50.94653 lon: 3.12269 facility: VITAZ status: NOT_YET_RECRUITING city: Sint-Niklaas zip: 9100 country: Belgium name: Bart De Troyer role: CONTACT name: Bart De Troyer role: PRINCIPAL_INVESTIGATOR lat: 51.16509 lon: 4.1437 hasResults: False |
<|newrecord|> nctId: NCT06282575 id: JZP598-302 id: 2023-508219-21-00 type: OTHER domain: CTIS briefTitle: Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer overallStatus: RECRUITING date: 2024-04-30 date: 2028-07-01 date: 2029-11-01 date: 2024-02-28 date: 2024-04-08 name: Jazz Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer. conditions: Biliary Tract Cancer conditions: HER2 Gene Mutation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 286 type: ESTIMATED name: Zanidatamab name: Cisplatin name: Gemcitabine name: Pembrolizumab name: Durvalumab measure: Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumors measure: Overall survival (OS) in participants with IHC 3+ tumors measure: Progression Free Survival for all participants measure: OS for all participants measure: Number of participants achieving Confirmed objective response rate (cORR) measure: Duration of response (DOR) measure: Number of Patients reporting Treatment-Emergent Adverse Events (TEAE) measure: Maximum serum concentration of Zanidatamab measure: Number of participants who develop Anti-drug antibodies (ADAs) to Zanidatamab measure: Time to definitive deterioration (TDD) for participants with IHC 3+ tumors in patient-reported Physical Functioning (PF) domain score as measured by the EORTC QLQ-C30 measure: TDD for all participants in patient-reported PF domain score as measured by the EORTC QLQ-C30 measure: TDD for participants with IHC 3+ tumors in patient-reported symptoms scores as measured by the EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain and Pruritis) measure: TDD for all participants in patient-reported symptoms scores as measured by the EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain, and Pruritis) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rocky Mountain Cancer Centers, LLP status: RECRUITING city: Lone Tree state: Colorado zip: 80124 country: United States lat: 39.55171 lon: -104.8863 facility: Norton Cancer Institute - Audubon status: NOT_YET_RECRUITING city: Louisville state: Kentucky zip: 40217 country: United States lat: 38.25424 lon: -85.75941 facility: Minnesota Oncology Hematology, P.A. status: RECRUITING city: Maple Grove state: Minnesota zip: 55369 country: United States lat: 45.07246 lon: -93.45579 facility: SCRI Oncology Partners status: RECRUITING city: Nashville state: Tennessee zip: 37203 country: United States lat: 36.16589 lon: -86.78444 facility: Texas Oncology - DFW status: RECRUITING city: Dallas state: Texas zip: 75246 country: United States lat: 32.78306 lon: -96.80667 facility: Hospital Oncologico, Puerto Rico Medical Center status: RECRUITING city: Rio Piedras zip: 00935 country: Puerto Rico lat: 18.39745 lon: -66.04989 hasResults: False |
<|newrecord|> nctId: NCT06282562 id: NL84223.018.23 briefTitle: FeelFit: High-intensity Interval Training to Improve Self-reported Physical Fitness in Brain Tumor Patients acronym: FeelFit overallStatus: RECRUITING date: 2024-03 date: 2026-08-15 date: 2026-08-15 date: 2024-02-28 date: 2024-03-06 name: Amsterdam UMC, location VUmc class: OTHER briefSummary: The FeelFit study aims to assess the effectiveness of High-Intensity Interval Training (HIIT) in improving self-reported physical fitness in adult brain tumor patients during periods of stable disease, as compared to a waiting-list control group. Furthermore, several secondary and exploratory outcomes will be evaluated. The study is part of the GRIP (GuaRding quality survivorshiP) project, which aims to improve quality of life in brain tumor patients. conditions: Brain Tumor, Primary conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 36 type: ESTIMATED name: High-Intensity Interval Training (HIIT) measure: Self-reported physical fitness measure: Self-reported fitness measure: VO2max measure: Daily physical activity measure: Health-related quality of life questionnaire measure: Perceived functional impairments measure: Self-efficacy measure: Mastery measure: Brain tumor specific quality of life questionnaire measure: Subjective Happiness measure: Subjective cognitive functioning measure: Subjective cognitive failure measure: Fatigue questionnaire measure: Sleep questionnaire measure: Anxiety questionnaire measure: Self-reported depression questionnaire measure: Depression questionnaire measure: Muscle strength measure: Subjective physical fitness measure: Objective neurocognitive functioning measure: Objective neurological functioning measure: Brain imaging (optional) measure: Brain activity (optional) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VU University Medical Centers, location VUmc status: RECRUITING city: Amsterdam zip: 1081 HV country: Netherlands name: Marieke Blom, Msc role: CONTACT phone: +31621522442 email: gripopfitheid@amsterdamumc.nl lat: 52.37403 lon: 4.88969 hasResults: False |
<|newrecord|> nctId: NCT06282549 id: YMC046 briefTitle: Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients With Essential Hypertension overallStatus: RECRUITING date: 2022-06-08 date: 2027-03-31 date: 2027-03-31 date: 2024-02-28 date: 2024-02-28 name: Yuhan Corporation class: INDUSTRY briefSummary: This study is to develop a predictive model for cardiocerebrovascular risk factors in elderly patients with essential hypertension with Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination. conditions: Essential Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1210 type: ESTIMATED name: Telmisartan/Amlodipine/Chlorthalidone(Truset) measure: Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) measure: Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) in patients with asymptomatic target organ damage measure: Mean Systolic Blood Pressure (MSBP)/ Diastolic Blood Pressure (MDBP) measure: Patients Achieving the treatment goal in Mean Systolic Blood Pressure (MSBP) measure: Percentage of patients who terminated the treatment sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Busan Veterans Hospital status: RECRUITING city: Busan zip: 46996 country: Korea, Republic of name: Jonghyun Choi role: CONTACT lat: 35.10278 lon: 129.04028 facility: Daegu Veterans Hospital status: RECRUITING city: Daegu zip: 42835 country: Korea, Republic of name: Sangwook Kang role: CONTACT lat: 35.87028 lon: 128.59111 facility: Gwangju Veterans Hospital status: RECRUITING city: Gwangju zip: 62284 country: Korea, Republic of name: Seowon Choi role: CONTACT lat: 35.15472 lon: 126.91556 facility: Konkuk University Medical Center status: RECRUITING city: Seoul zip: 05030 country: Korea, Republic of name: Chanhee Kwon role: CONTACT lat: 37.566 lon: 126.9784 facility: Veterans Health Service Medical Center status: RECRUITING city: Seoul zip: 05368 country: Korea, Republic of name: Changhoon Lee role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False |
<|newrecord|> nctId: NCT06282536 id: LungMate-018 briefTitle: Neoadjuvant Therapy With Iruplinalkib for Potentially Resectable ALK Positive NSCLC: A Single Arm, Exploratory Trial overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-06 date: 2029-12 date: 2024-02-28 date: 2024-02-28 name: Shanghai Pulmonary Hospital, Shanghai, China class: OTHER briefSummary: Fusion of anaplastic lymphoma kinase (ALK) is an important driving gene for NSCLC, with an incidence rate of 3-7%. In patients with advanced ALK mutation NSCLC, first-line use of ALK inhibitors significantly improves progression free survival. The perioperative research on ALK positive NSCLC was relatively late, and currently most studies mainly focus on early to mid stage ALK positive NSCLC patients. The results of two Phase III clinical trials showed that second-generation ALK targeted drugs, neoadjuvant and/or adjuvant therapy for ALK positive NSCLC, significantly prolonged DFS in patients, including increased pathological response rate, median response duration, and prolonged OS. For ALK positive advanced NSCLC patients who are resistant to second-generation ALK targeted drugs, there is currently limited exploration and there is an urgent need for new exploratory clinical studies.This trial aims to evaluate the effectiveness of Iruplinalkib neoadjuvant therapy for potentially resectable ALK positive non-small cell lung cancer. conditions: Potentially Resectable ALK Positive Non-Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All enrolled patients received Iruplinalkib neoadjuvant therapy. primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Iruplinalkib name: surgery measure: Objective response rate (ORR) measure: Pathologic complete response (PCR) rate measure: Major pathologic response (MPR) rate measure: Overall survival (OS) measure: Event-free survival (EFS) measure: Treatment-related adverse event (TRAE) measure: 5-year overall survival (OS) measure: 1-year event-free survival (EFS) rate measure: Health related quality of life (HRQol) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06282523 id: 2023-1773 id: A171600 type: OTHER domain: UW- Madison id: EDUC/COUNSELING PSYCH type: OTHER domain: UW- Madison id: Protocol Version 12/27/23 type: OTHER domain: UW- Madison briefTitle: Healthy Minds Comparison Study overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-06 date: 2024-06 date: 2024-02-28 date: 2024-04-25 name: University of Wisconsin, Madison class: OTHER briefSummary: The goal of this clinical trial is to understand the difference between two versions of the Healthy Minds application, a digital well-being program. The main question it aims to answer is the differences between versions of the Healthy Minds application and their effects on well-being. |
Participants will complete a four-week well-being program and complete surveys via an app on their phone. Participants can expect to participate in the study for four months. conditions: Depression conditions: Anxiety conditions: Depression/Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 460 type: ESTIMATED name: HMP app name: HMRP web app measure: Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety measure: HMP App Utilization: Days measure: HMP App Utilization: Number of Activities measure: HMP App Utilization: Minutes measure: Change in Healthy Minds Index (HM Index): Awareness measure: Change in Healthy Minds Index (HM Index): Connection measure: Change in Healthy Minds Index (HM Index): Purpose measure: Change in Healthy Minds Index (HM Index): Insight measure: Change in Subjective Happiness Scale measure: Change in Satisfaction with Life Scale (SWLS) measure: Change in Perceived Stress Scale (PSS-10) measure: Change in Flourishing Measure measure: Change in Digital Working Alliance Inventory (DWAI) measure: Change in Experiences Questionnaire (EQ) Decentering Subscale measure: Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale measure: Change in NIH Toolbox Loneliness measure: Change in Wellbeing Growth Mindset measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Wisconsin city: Madison state: Wisconsin zip: 53705 country: United States name: Simon Goldberg, PhD role: CONTACT phone: 608-265-8986 email: sbgoldberg@wisc.edu name: Simon Goldberg, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False |
<|newrecord|> nctId: NCT06282510 id: 23053003 briefTitle: Nasal Antisepsis for C. Auris Prevention overallStatus: RECRUITING date: 2024-01-29 date: 2026-12 date: 2028-12 date: 2024-02-28 date: 2024-02-28 name: Mary K Hayden class: OTHER name: Rush University Medical Center name: RML Specialty Hospital briefSummary: This is a randomized, controlled, open-label trial of effect of 10% povidone iodine intranasal antisepsis on the detection of Candida auris. conditions: Candida Auris Infection conditions: Colonization, Asymptomatic studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Povidone Iodine Topical measure: Detection of C. auris from the anterior nares measure: Detection of C. auris from body sites other than anterior nares measure: Detection of C. auris from environmental surfaces measure: Detection of methicillin-resistant Staphylococcus aureus (MRSA) from body sites other than anterior nares measure: Detection of MRSA from environmental surfaces measure: Non-susceptibility of C. auris to povidone iodine measure: Change in microbiome community sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rush University Medical Center status: RECRUITING city: Chicago state: Illinois zip: 60612 country: United States name: Sarah E Sansom, DO role: CONTACT phone: 312-563-6201 email: sarah_e_sansom@rush.edu name: Mary K Hayden, MD role: CONTACT phone: 312-942-8727 email: mhayden@rush.edu lat: 41.85003 lon: -87.65005 facility: RML Specialty Hospital status: RECRUITING city: Chicago state: Illinois zip: 60624 country: United States name: Nidhi Undevia, MD role: CONTACT phone: 630-286-4000 email: nundevia@rmlspecialtyhospital.org name: Lisa Duffner role: CONTACT phone: 630-286-4000 email: LMikolajewski@rmlspecialtyhospital.org lat: 41.85003 lon: -87.65005 facility: RML Specialty Hospital status: RECRUITING city: Hinsdale state: Illinois zip: 60521 country: United States name: Nidhi Undevia, MD role: CONTACT phone: 630-286-4000 email: nundevia@rmlspecialtyhospital.org name: Lisa Duffner role: CONTACT phone: (630) 286-4000 email: LMikolajewski@rmlspecialtyhospital.org lat: 41.80086 lon: -87.93701 hasResults: False |
<|newrecord|> nctId: NCT06282497 id: ZSCPH-003 briefTitle: Xerostomia-optimised IMRT Versus Standard IMRT in NPC overallStatus: RECRUITING date: 2023-10-23 date: 2026-10-23 date: 2029-10-23 date: 2024-02-28 date: 2024-02-28 name: Zhongshan People's Hospital, Guangdong, China class: OTHER briefSummary: This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in NPC patients conditions: Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 524 type: ESTIMATED name: Optimised neck CTV name: standard neck CTV measure: Regional recurrence free survival measure: Overall survival measure: Local recurrence free survival measure: Distant metastasis-free survival measure: Progression free survival measure: Acute toxicities measure: Late toxicities sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan City People's Hospital status: RECRUITING city: Zhongshan state: Guangdong zip: 528403 country: China name: Gui-qiong Xu, MD role: CONTACT phone: +8613528109888 email: donna_shee@163.com lat: 21.31992 lon: 110.5723 hasResults: False |
<|newrecord|> nctId: NCT06282484 id: KY20232348-C-1 briefTitle: A Study on the Relationship Between Gastric Xanthoma and Gastric Cancer and Precancerous Lesions overallStatus: COMPLETED date: 2022-09-01 date: 2023-06-01 date: 2023-09-29 date: 2024-02-28 date: 2024-02-28 name: Xijing Hospital of Digestive Diseases class: OTHER briefSummary: To explore the effects of gastric xanthoma on gastric cancer and its precancerous lesions, so as to better prevent the occurrence and development of gastric cancer. conditions: Gastric Xanthoma conditions: Helicobacter Pylori Infection conditions: Gastric Cancer conditions: Intestinal Metaplasia conditions: Precancerous Lesions studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 1260 type: ACTUAL measure: corelation between the gastric xanthoma and gastric mucosa diseases sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xijing Hosipital of Digestive Disease city: Xi'an state: Shaanxi zip: 710032 country: China lat: 34.25833 lon: 108.92861 hasResults: False |
<|newrecord|> nctId: NCT06282471 id: MCC-23-20794 id: HM20028614 type: OTHER domain: Virginia Commonwealth University briefTitle: EW and Self-Guided PST in Cancer Survivors and Caregivers overallStatus: RECRUITING date: 2024-02-21 date: 2026-03-31 date: 2026-03-31 date: 2024-02-28 date: 2024-02-29 name: Virginia Commonwealth University class: OTHER briefSummary: To assess the feasibility and acceptability of expressive writing + problem solving therapy (EW+PST) among cancer survivors and informal caregivers conditions: Cancer Survivors conditions: Informal Caregivers studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: Expressive Writing and Problem-Solving Therapy (EW+PST) measure: Consent Rate measure: Study Retention measure: Completed Journal Entries measure: Patient Satisfaction Questionnaire measure: Change in Post Traumatic Growth Inventory (PTGI) Score from 0 to 6 weeks measure: Change in European Organization for the Research and Treatment of Life Questionnaire (EORTC QLQ-30) Score from 0 to 6 weeks measure: Change in Patient Health Questionnaire-8 (PHQ-8) Score from 0 to 6 Weeks measure: Change in Perceived Stress Scale-10 item (PSS-10) Score from 0 to 6 Weeks measure: Change in New General Self-Efficacy Scale (GSES-N) Score from 0 to 6 Weeks measure: Change in Multidimensional Scale of Perceived Social Support (MSPSS) Score from 0 to 6 Weeks measure: Change in Family Environment Scale-Revised (FES-R) Score from 0 to 6 Weeks measure: Change in Cancer Communication Assessment Tool for Patients and Families (CCAT-PF) Score from 0 to 6 Weeks measure: Change in Caregiver Burden Scale (CBS) Score from 0 to 6 Weeks measure: Change in EORTC Quality of Life Core Scale (EORTC QLQ-30) Score from 0 to 6 Weeks sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Virginia Commonwealth University status: RECRUITING city: Richmond state: Virginia zip: 23298 country: United States name: Kendra Rowe role: CONTACT phone: 804-828-1965 email: rowek2@vcu.edu name: Massey CPC Team role: CONTACT phone: 804-828-1965 email: MasseyCPC@vcu.edu name: Susan Hong, MD role: PRINCIPAL_INVESTIGATOR lat: 37.55376 lon: -77.46026 hasResults: False |
<|newrecord|> nctId: NCT06282458 id: V2000101 briefTitle: Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2024-12-20 date: 2025-04-30 date: 2024-02-28 date: 2024-04-24 name: Veru Inc. class: INDUSTRY briefSummary: The primary objective of this study is to assess the effect of enobosarm on total lean mass as measured by DEXA in patients maintained on GLP-1 receptor agonists. conditions: Muscle Loss conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Subjects will be randomized to the three treatment arms (GLP-1 receptor agonist plus either enobosarm 3mg dose group, enobosarm 6mg dose group, or placebo group) in a 1:1:1 fashion. All patients randomized into this study will be medically indicated for use of GLP-1 receptor agonist for weight management. NOTE: First dose of GLP-1 receptor agonist will be Day 1 of this study. |
The primary efficacy endpoint of the study will be the change from baseline in total lean mass at 4 months (112 days). Subjects will continue enobosarm (or matching placebo) monotherapy treatment from Day 112 to Day 196 to assess the effect of enobosarm on total lean mass, total muscle mass, maintenance of weight loss, and rebound fat gain after discontinuation of GLP-1 receptor agonists. A safety follow-up visit will occur approximately 30 days after last dose of study drug. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Double Blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: Enobosarm name: Semaglutide measure: The primary endpoint for the study is the percentage change from baseline in total lean body mass at 112 days. measure: The percent change from baseline in total fat mass sex: ALL minimumAge: 60 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pinnacle Trials city: Anniston state: Alabama zip: 36207 country: United States name: April Bolt role: CONTACT phone: 256-460-6379 email: Abolt@Pinnacletrials.com name: Almena Free role: PRINCIPAL_INVESTIGATOR lat: 33.65983 lon: -85.83163 facility: Cullman Clinical Trials city: Cullman state: Alabama zip: 35055 country: United States name: Cheryl Hargrove role: CONTACT phone: 256-708-2826 email: cheryl@cullmanclinicaltrials.com name: Randall Quinn role: PRINCIPAL_INVESTIGATOR lat: 34.17482 lon: -86.84361 facility: Velocity Clinical Research, CA city: Los Angeles state: California zip: 90057 country: United States name: Jenny Francisco role: CONTACT phone: 213-413-2500 email: JFrancisco@velocityclinical.com name: David Guzman role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: Artemis Institute for Clinical Research city: San Diego state: California zip: 92103 country: United States name: Analicia Murillo role: CONTACT phone: 858-867-3557 email: analicia.murillo@artemis-research.com name: Stacy Layle role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 facility: Universal Axom Clinical Research city: Doral state: Florida zip: 33122 country: United States name: Diana Marinez role: CONTACT phone: 305-677-9267 phoneExt: 24 email: Dmarinez@uaclinical.com name: Luis Martinez role: PRINCIPAL_INVESTIGATOR lat: 25.81954 lon: -80.35533 facility: Altus Research city: Lake Worth state: Florida zip: 33461 country: United States name: Junieth Leyes role: CONTACT phone: 561-641-0404 email: jleyes@altusresearch.com name: Samuel Lederman role: PRINCIPAL_INVESTIGATOR lat: 26.61708 lon: -80.07231 facility: MARC Research Center city: Louisville state: Kentucky zip: 40213 country: United States name: Laken Heitz role: CONTACT phone: 502-214-3925 email: lheitz@lmarc.com name: Harold Bays role: PRINCIPAL_INVESTIGATOR lat: 38.25424 lon: -85.75941 facility: Pennington Biomedical city: Baton Rouge state: Louisiana zip: 70810 country: United States name: Aubrey Windham role: CONTACT phone: 225-763-2618 email: aubrey.windham@pbrc.edu name: Steven Heysmfield role: PRINCIPAL_INVESTIGATOR lat: 30.45075 lon: -91.15455 facility: DelRicht Research - New Orleans city: New Orleans state: Louisiana zip: 70115 country: United States name: Emily Krambeck role: CONTACT phone: 504-336-2667 email: ekrambeck@delricht.com name: Patrick Dennis role: PRINCIPAL_INVESTIGATOR lat: 29.95465 lon: -90.07507 facility: Centennial Medical Group (CMG) city: Elkridge state: Maryland zip: 21075 country: United States name: Tyler Stine role: CONTACT phone: 443-698-8678 email: TSTINE@centennialmedical.com name: Steven Geller role: PRINCIPAL_INVESTIGATOR lat: 39.21261 lon: -76.71358 facility: SKY Integrative Medical Center city: Ridgeland state: Mississippi zip: 39157 country: United States name: Bob Hutchins role: PRINCIPAL_INVESTIGATOR lat: 32.42848 lon: -90.13231 facility: Clinvest Headlands LLC city: Springfield state: Missouri zip: 65807 country: United States name: Kealon Cox role: CONTACT phone: 417-883-7889 email: kealon.cox@clinvest.com name: David True role: PRINCIPAL_INVESTIGATOR lat: 37.21533 lon: -93.29824 facility: Palm Research Center city: Las Vegas state: Nevada zip: 89119 country: United States name: Sasha Sandry role: CONTACT phone: 702-736-5161 email: sasha@palmresearchcenter.com name: Samer Nakhle role: PRINCIPAL_INVESTIGATOR lat: 36.17497 lon: -115.13722 facility: Lillestol Research LLC city: Fargo state: North Dakota zip: 58104 country: United States name: Michael Lillestol role: CONTACT phone: 701-232-7705 email: lillestolmd@lillestolresearch.com name: Michael Lillestol role: PRINCIPAL_INVESTIGATOR lat: 46.87719 lon: -96.7898 hasResults: False |
<|newrecord|> nctId: NCT06282445 id: K2024035 briefTitle: Efficacy and Safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2026-03-31 date: 2024-02-28 date: 2024-02-28 name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: To evaluate the efficacy and safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer. conditions: Colorectal Cancer Metastatic studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Adebrelimab name: Oxaliplatin name: Capecitabine name: Bevacizumab measure: Progression-free survival measure: Organ retention rate measure: Overall survival measure: Disease Control Rate measure: Surgical conversion rate measure: TRAEs sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Fourth Affiliated Hospital Zhejiang University School of Medicine status: RECRUITING city: Jinhua state: Zhejiang zip: 322000 country: China name: Qijia Xuan, MD&Phd role: CONTACT lat: 29.10678 lon: 119.64421 hasResults: False |
<|newrecord|> nctId: NCT06282432 id: RP-L201-0121-LTFU briefTitle: Long-Term Follow-Up (LTFU) for Gene Therapy of Leukocyte Adhesion Deficiency-I (LAD-I) overallStatus: ENROLLING_BY_INVITATION date: 2022-03-09 date: 2037-03 date: 2037-03 date: 2024-02-28 date: 2024-02-28 name: Rocket Pharmaceuticals Inc. class: INDUSTRY briefSummary: This Long-Term Follow-Up (LTFU) for Gene Therapy of Leukocyte Adhesion Deficiency-I (LAD-I) is a continuation of a Phase 1/2 clinical study to evaluate the safety and efficacy of the infusion of autologous hematopoietic stem cells transduced with a lentiviral vector encoding the ITGB2 gene conditions: Leukocyte Adhesion Deficiency studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 9 type: ESTIMATED measure: Hematopoietic stem cell transplant (HSCT) free survival measure: Incidence of hospitalizations measure: Incidence of significant infections measure: Resolution of LAD-I-related skin rash measure: Resolution of LAD-I-related periodontal abnormalities measure: Event free survival measure: Overall Survival measure: Long-term genetic correction in peripheral blood mononuclear cells (PBMCs) measure: Long-term genetic correction in PB CD15+ granulocytes measure: Long-term CD18 neutrophil expression by flow cytometry measure: Long-term CD11 neutrophil expression by flow cytometry measure: Improvement or resolution of LAD-I related neutrophilia measure: Improvement or resolution of LAD-I-related leukocytosis. measure: Incidence of Investigational Product (IP) related serious adverse events (SAEs) measure: Incidence of hematologic malignancy sex: ALL minimumAge: 3 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, Los Angeles (UCLA) city: Los Angeles state: California zip: 90095-1489 country: United States lat: 34.05223 lon: -118.24368 facility: Hospital Infantil Universitario Niño Jesús city: Madrid zip: 28009 country: Spain lat: 40.4165 lon: -3.70256 facility: University College London Great Ormond Street Institute of Child Health (GOSH) city: London zip: WC1N 1EH country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False |
<|newrecord|> nctId: NCT06282419 id: B.30.2.ATA.0.01.00/542 briefTitle: The Effect of Visual and Audio Stimulus Offered to Father-to-be overallStatus: RECRUITING date: 2023-08-21 date: 2024-03-31 date: 2025-12-31 date: 2024-02-28 date: 2024-03-01 name: Ataturk University class: OTHER briefSummary: It was aimed to evaluate the effect of visual and auditory stimuli presented to father candidates on postpartum breastfeeding success of mothers, perception of spousal support and postpartum depression. The study, which was carried out in a randomized controlled experimental design, consists of nulliparous pregnant women and their spouses who came to the relevant health center for prenatal control between May 2023 and May 2024. In the study, 132 pregnant women (Experimental group 1:44, Experimental group 2:44, control group:44) were recruited with a priori power analysis. In the study, women and their spouses were assigned to the experimental and control groups by randomization. For randomization, single-group columns between 1-165 were created in the system using the Random Integer Generator method in the Numbers subheading of the random.org website. Considering the numbers 1, 2 and 3 in the column, nulliparous pregnant women coming to the polyclinic were randomly assigned to these numbers. Which numbers constitute which group was determined by drawing lots at the beginning of the research. In data collection, Introductory Information Form for women, Women's Perceived Spousal Support Scale in Early Postpartum Process, Breastfeeding Self-Efficacy Scale-Short Form, Breastfeeding Adaptation Scale and Edinburgh Postpartum Depression Scale; Introductory Information Form for men, Fathers; Breastfeeding Attitude and Participation Scale and Edinburgh Postpartum Depression Scale (for Men) were used. Data; It was evaluated in the SPSS program. conditions: Ultrasonography Prenatal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a study that evaluates the effects on mothers by involving fathers in the pregnancy follow-up process through the use of mobile ultrasound. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 132 type: ESTIMATED name: USE OF MOBILE ULTRASOUND name: ultrasound image taken from the internet measure: Introductory Information Form (For Women) measure: Spouse Support Scale Perceived by Women During Early Postpartum Period measure: Breastfeeding Self-Efficacy Scale-Short Form measure: Breastfeeding Adaptation Scale measure: Edinburgh Postpartum Depression Scale measure: Introductory Information Form (For Men) measure: Fathers' Breastfeeding Attitude and Participation Scale measure: Edinburgh Postpartum Depression Scale for Men sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Atatürk University status: RECRUITING city: Erzurum country: Turkey name: Merve Çakıl role: CONTACT phone: +905310854245 email: mervecakil92@gmail.com name: Ayla KANBUR role: CONTACT email: aylakanbur28@hotmail.com lat: 39.90861 lon: 41.27694 hasResults: False |
<|newrecord|> nctId: NCT06282406 id: N4532-R id: I0X1RX004532 type: OTHER_GRANT domain: U.S. Department of Veterans Affairs briefTitle: Pupil-Indexed Noninvasive Neuromodulation overallStatus: NOT_YET_RECRUITING date: 2024-06-03 date: 2028-04-03 date: 2028-08-05 date: 2024-02-28 date: 2024-02-28 name: VA Office of Research and Development class: FED briefSummary: Vagus nerve stimulation (VNS) is thought to activate neural pathways that release chemicals which promote plasticity and learning. Previous work has shown that the auricular branch of the vagus nerve innervates landmarks on the external ear. Work from the PI's laboratory has shown that electrical current applied to the external ear modulates physiological indexes of brain states implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms modulated by auricular stimulation to support possible therapeutic effects in the form of motor learning. conditions: Paresis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Subjects will be randomized into one of 5 groups and receive the designated stimulation/sham during a training protocol designed to facilitate motor learning. primaryPurpose: TREATMENT masking: NONE count: 110 type: ESTIMATED name: Transcutaneous Electrical Stimulation name: Sham measure: Force Control Change sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA city: Pittsburgh state: Pennsylvania zip: 15240 country: United States name: Elizabeth B Toth, BA role: CONTACT phone: 412-954-5382 email: elizabeth.toth2@va.gov name: Kimberly A Toland role: CONTACT phone: (412) 215-5084 email: Kimberly.Toland@va.gov name: Michael A. Urbin, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False |
<|newrecord|> nctId: NCT06282393 id: Z-2023072 briefTitle: FibriCheck Data Registry acronym: FDR overallStatus: RECRUITING date: 2024-01-31 date: 2026-02 date: 2026-03 date: 2024-02-28 date: 2024-02-28 name: Qompium NV class: INDUSTRY briefSummary: The goal of this interventional clinical trial is to establish a comprehensive, structured database that includes photoplethysmography (PPG) measurements with simultaneously recorded electrocardiography (ECG) data to evaluate the FibriCheck Algorithm in patients with heart rhythm disorders. conditions: Cardiac Arrhythmia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 150 type: ESTIMATED name: FibriCheck recordings measure: Alignment PPG measurement sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ziekenhuis Oost Limburg status: RECRUITING city: Genk state: Limburg zip: 3600 country: Belgium name: Pieter Vandervoort, MD role: CONTACT phone: 089/325050 email: pieter.vandervoort@zol.be lat: 50.965 lon: 5.50082 hasResults: False |
<|newrecord|> nctId: NCT06282380 id: FDA-AF study briefTitle: Fibricheck Detection cApabilities for Atrial Fibrillation acronym: FDA-AF overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-05 date: 2024-05 date: 2024-02-28 date: 2024-02-28 name: Qompium NV class: INDUSTRY briefSummary: Evaluation of accuracy of the FibriCheck Mobile Application on various smartphone devices, compared to the reference diagnosis. conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 250 type: ESTIMATED name: FibriCheck Mobile Application measure: Accuracy of the FibriCheck Mobile Application measure: Sensitivity of the FibriCheck Mobile Application measure: Specificity of the FibriCheck Mobile Application sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06282367 id: JOSE AGURTO TELLO HOSPITAL briefTitle: Bowel Preparation for Colonoscopy With Oral Lactulose overallStatus: COMPLETED date: 2021-07-01 date: 2023-04-01 date: 2023-04-01 date: 2024-02-28 date: 2024-02-28 name: Josue Aliaga class: OTHER_GOV briefSummary: Background and Aims: The quality of colonoscopy is critically influenced by bowel preparation. Polyethylene glycol (PEG) is considered the gold standard regimen for bowel preparation, however due to the necessity of large volume of patient's tolerance is impaired, especially in the elderly population. Lactulose has been adopted in a few centers as a novel alternative for colonoscopy preparation. This study aimed to investigate the efficacy-safety profile of a lactulose-based bowel preparation in comparison to PEG for colonoscopy. |
Methods: Prospective non-blinded comparative study, developed in two tertiary centers from July 2021 to April 2023. Outpatients undergoing colonoscopy were randomly divided into 2 groups: Group 1 (111 patients): PEG and Group 2 (111 patients): Lactulose. The following clinical outcomes were assessed for each group: degree of bowel clearance using the Boston Score, colorectal polyp detection rate, adenoma detection rate, tolerability and side effects. conditions: Colonoscopy conditions: Colonoscopy Preparation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 222 type: ACTUAL measure: Degree of bowel cleansing using the Boston score measure: adenomas detection rate sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jose Agurto Tello Hospital city: Lima zip: 05001 country: Peru lat: -12.04318 lon: -77.02824 hasResults: False |
<|newrecord|> nctId: NCT06282354 id: NP4035/2023 briefTitle: Telemedicine for Postoperative Follow-up After Oncological Surgeries overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-15 date: 2025-02-15 date: 2024-02-28 date: 2024-02-28 name: Instituto do Cancer do Estado de São Paulo class: OTHER briefSummary: The study will be a prospective, randomized, non-inferiority, open-label study, to be carried out at the Cancer Institute of the State of São Paulo for 6 months and will include patients agreeing to voluntary participation upon signing an informed consent form. conditions: Urologic Cancer conditions: Satisfaction, Patient conditions: Surgery conditions: Postoperative Adhesion studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Type of post-operative appointment measure: Patient satisfaction in the post-operative return measure: unattended arrivals at the institution measure: Postoperative complications measure: Appointment's time measure: Number of exams requested measure: Total cost involved per service measure: Environmental impact sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06282341 id: 23CH132 briefTitle: Fatigue and Recovery: a Comparison Between Trail and Marathon acronym: MARA-TRAIL overallStatus: RECRUITING date: 2023-12-28 date: 2025-08 date: 2025-09 date: 2024-02-28 date: 2024-02-28 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: Road marathon is a famous running race known for hundreds of years. Trail running is an emerging running discipline which count new runners every year. Trail running and road marathon are two running endurance disciplines which differed by variation of elevation and nature of the terrain. While marathon is essentially run on flat roads, trail races are realized on steep paths (mountain, desert...) with an important variation of elevation. Neuromuscular, biomechanical and physiological consequences are different depending on the discipline, especially with a greater eccentric contribution in trail running. In spite of this characteristic, trail runners take part in several races longer than 40 km per year, while road runners participate in one to two marathons per year. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective study on healthy volunteers, comparing the neurophysiological, physiological and biomechanical effects at the end of a marathon compared with an equivalent effort trail in the open air, or simulated on a treadmill, in runners specialising in each of the 2 disciplines primaryPurpose: SCREENING masking: NONE count: 90 type: ESTIMATED name: Race: Simulated marathon name: Race: Simulated trail name: Race: Trail in nature measure: Change in knee extensors maximal isometric torque output measure: Change in plantar flexor maximal isometric torque output measure: Recovery of quadriceps maximal isometric torque output the month after the race measure: Voluntary activation level measure: Force assessed in dynamic measure: Velocity assessed in dynamic measure: Power assessed in dynamic measure: Muscular power and stretch-shortening cycle assessed through squat jumps measure: Muscular power and stretch-shortening cycle assessed through countermovement jump measure: Muscular power and stretch-shortening cycle assessed through drop jump measure: Muscle electrical activity measure: The kinetics of energy cost measure: Racing kinematics measure: Ground reaction force (in Newton) measure: Center of pressure (in Newton) measure: Muscle damage blood markers measure: Resting heart rate variability parameters measure: Effort perception measure: fatigue assessment measure: Muscular pain sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Unités de Myologie et de Médecine du Sport status: RECRUITING city: Saint-Étienne zip: 42055 country: France name: Léonard FEASSON, Phd role: CONTACT phone: 04 77 12 03 83 email: leonard.feasson@chu-st-etienne.fr name: Diana RIMAUD role: CONTACT email: diana.rimaud@chu-st-etienne.fr name: Clément FOSCHIA, Dr role: SUB_INVESTIGATOR name: Pascal EDOUARD, Dr role: SUB_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False |
<|newrecord|> nctId: NCT06282328 id: CET 26-2024 briefTitle: HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting acronym: HIV-HOTE overallStatus: RECRUITING date: 2024-02-14 date: 2025-11-01 date: 2026-03-01 date: 2024-02-28 date: 2024-03-18 name: Castagna Antonella class: OTHER briefSummary: This study aims to evaluate the prevalence of previously undiagnosed HIV infection in the hospital setting (across various medical or surgical departments) among individuals exhibiting at least one HIV indicator condition (HIV-IC) and/or engaging in risky behaviors. |
This is a cross-sectional, single-center study with additional procedures. Data collection will involve clinical and laboratory data from individuals with at least one HIV-IC and/or behavioral risk factor for HIV infection admitted to the San Raffaele Hospital in Milan for any reason. |
The overall study duration is 24 months, with recruitment lasting 20 months. Individuals will be actively recruited from various medical or surgical units of the hospital. After obtaining informed consent, clinical and laboratory information related to the study will be collected, along with specific blood samples. The presence of at least one HIV-IC will be determined using available clinical, radiological, and laboratory parameters during hospitalization. |
Following informed consent, hospitalized individuals will complete a paper questionnaire, aimed at identifying behavioral risk factors for HIV infection. If at least one HIV-IC or behavioral risk factor is present, the person will be eligible for inclusion in the clinical study, and a rapid capillary HIV test will be conducted bedside. |
In case of a positive rapid capillary HIV test result, antigen/antibody testing and Western Blot for HIV confirmation will be performed on venous blood samples on the same day. conditions: Hiv conditions: HIV Infections conditions: AIDS studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 1000 type: ESTIMATED name: HIV test measure: Prevalence of HIV infection measure: Number of HIV-IC measure: Number of Behavioral Risk Factors measure: CD4+ lymphocytes measure: HIV-RNA sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS San Raffaele Scientific Institute status: RECRUITING city: Milan zip: 20127 country: Italy name: Elisabetta Carini role: CONTACT phone: +0039 0226437934 email: carini.elisabetta@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False |
<|newrecord|> nctId: NCT06282315 id: REALISE briefTitle: Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2026-02 date: 2026-06 date: 2024-02-28 date: 2024-02-28 name: Insud Pharma class: INDUSTRY name: Ghana Health Services name: Kenya Medical Research Institute name: Bridges to Development name: Sanger Institute name: Barcelona Institute for Global Health name: European Union name: Swiss Confederation name: Mundo Sano briefSummary: An open-label, randomized by school, two-arm pragmatic trial, will be conducted involving two study sites in Sub-Saharan-Africa (SSA), Ghana and Kenya, to evaluate safety and effectiveness of the newly developed fixed dose combination (FDC) of albendazole (ALB) and ivermectin (IVM) as a single dose to treat Soil-Transmitted Helminths (STH), compared to the standard dose ALB single dose for the treatment and control of STH (REALISE study: Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness). The general objectives are to validate the benefits of FDC through this pragmatic trial in a context of mass drug administration (MDA) programme to evaluate the safety as a primary endpoint and effectiveness profile as a secondary endpoint, in a large population of school-aged children. conditions: Soil-Transmitted Helminths studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Open-label, randomized at the school level, and each eligible participant within a school will receive only one of the study treatments (ALB or IVM). primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This is an open study. Participants and the study investigators assessing drug safety will not be blinded to treatment arms. Only the laboratory-based effectiveness measurement will be performed by blinded operators. whoMasked: OUTCOMES_ASSESSOR count: 20000 type: ESTIMATED name: Pre-screening Phase name: Screenig Phase name: Randomization name: Baseline Effectiveness Cohort name: Day 0 Trial Intervention name: Active Surveillance (study visit Day 1, Day 2 and Day 7) name: Passive Surveillance name: Post-Treatment Effectiveness Evaluation measure: AEs and SAEs record of participants treated with FDC compared to ALB. measure: Reduction in T. trichiura prevalence in participants treated with FDC compared with ALB. measure: Exploratory 1: Reduction in Strongyloides stercoralis seroprevalence in participants treated with FDC compared with ALB. measure: Exploratory 2: Reduction in hookworms and A. lumbricoides prevalence in participants treated with FDC compared with ALB. measure: Exploratory 3: Reduction in A. lumbricoides prevalence in participants treated with FDC compared with ALB. measure: Exploratory 4: Describe the frequency of scabies before and after the intervention in the two treatment arms. measure: Exploratory 5: (i) Genetic diversity within and between T. trichiura populations, relative to the FDC or ALB study participants. measure: Exploratory 5: (ii) Genetic diversity in candidate genes and identification of genes and/or regions in the genome of T. trichiura under selective pressure due to the treatment with FDC and/or ALB; measure: Exploratory 5: (iii) Relative abundance of mixed parasite species within and between populations and in response to treatment in the FDC or ALB study participants. measure: Exploratory 6: (i) Characterization of the microbiome composition at baseline and its implication in MDA effectiveness measure: Exploratory 6: (ii) Determine the Impact of MDA with ALB or FDC on the microbiome composition at population level measure: Exploratory 6: (iii) Measure the Recovery of the baseline microbiome composition at 11 months post-treatment and its role in reinfection with STH. sex: ALL minimumAge: 5 Years maximumAge: 17 Years stdAges: CHILD facility: Ghana Health Service (GHS) city: Accra country: Ghana name: Abraham Oduro, PM role: CONTACT phone: +233 (0) 50 469 8534 email: aroduro@gmail.com name: Joseph Opare, PI role: CONTACT email: kwadwolarbiopare@gmail.com lat: 5.55602 lon: -0.1969 facility: Kenya Medical Research Institution (KEMRI) city: Nairobi zip: 00200 country: Kenya name: Benson Singa, PI role: CONTACT phone: +254-720018880 email: singabo2008@gmail.com/bsinga@kemri.go.ke name: Stella Kepha, PM role: CONTACT email: stellakepha2005@yahoo.com lat: -1.28333 lon: 36.81667 hasResults: False |
<|newrecord|> nctId: NCT06282302 id: 6030/22 briefTitle: Effect of Isometric and Aerobic Physical Exercise on Blood Pressure Levels in Hypertensive Elderly People overallStatus: RECRUITING date: 2024-01-20 date: 2024-03-18 date: 2024-04-30 date: 2024-02-28 date: 2024-02-28 name: Instituto de Cardiologia do Rio Grande do Sul class: OTHER briefSummary: Introduction: Adequate blood pressure control is necessary to reduce the risk of mortality from cardiovascular events. The effects of aerobic exercise on systemic arterial hypertension are already well known, however, to date, there is little evidence regarding the effect of an isometric exercise session for the lower limbs on blood pressure levels, especially when performed in elderly hypertensive individuals. Objective: To verify the effect of an isometric or aerobic exercise protocol for the lower limbs on 24-hour ambulatory blood pressure in elderly hypertensive individuals. conditions: Hypertension,Essential conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The RCT will involve thirty-six elderly volunteers (≥ 60 years of age) with systemic arterial hypertension, aiming to compare two types of physical exercise sessions, isometric wall squats and an aerobic exercise session on an exercise bike, on the 24-hour blood pressure levels. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Group control name: Isometric Exercise name: Aerobic Exercise measure: 24-hour Ambulatory Blood Pressure Monitoring sex: ALL minimumAge: 60 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Cardiology status: RECRUITING city: Porto Alegre state: RS zip: 900.620-000 country: Brazil name: Lidiane P Stochero role: CONTACT phone: 5554981301920 email: lidistochero3@gmail.com lat: -30.03306 lon: -51.23 hasResults: False |
<|newrecord|> nctId: NCT06282289 id: 2023-077 id: 2023-A01798-37 type: OTHER domain: ID RCB briefTitle: Elicitation of Steady-state Audiovisual Responses in 6- and 10-month-old Infants acronym: AV-SSR-I overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-09-21 date: 2025-09-21 date: 2024-02-28 date: 2024-03-06 name: Institut Pasteur class: INDUSTRY name: Institut de l'Audition briefSummary: The goal of this study is to investigate the preferential responses of speech neural systems in infants. |
The main question it aims to answer is to determine whether the oscillatory synchronization capacity is associated with children's language level (i.e. vocabulary). |
Participants will be presented with synthetically modulated stimuli at three frequency scales: 4 Hz, 5 Hz and 30 Hz. conditions: Speech studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 64 type: ESTIMATED name: Magnetoencephalography (MEG) name: Cognition development questionnaire measure: Significance of correlation between the delta (i.e. difference) of synchronization power estimated at 10- and 6-months of age and the delta of vocabulary level measured at 18months of age. measure: The equation for linear regression analysis used to estimate the amount of neuronal synchronization between auditory and visual perception systems according to the Coherence and the Synchrony of AV inputs measure: The equation for linear regression analysis used to estimate the variation in the amount of neuronal synchronization between 4 experimental conditions according to the Coherence and the Synchrony of AV inputs sex: ALL minimumAge: 6 Months maximumAge: 10 Months stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06282276 id: 012922HYMC briefTitle: Anti-fat Attitudes and Weight Stigma Among Orthopedic Surgeons overallStatus: COMPLETED date: 2022-10-01 date: 2023-01-01 date: 2023-01-01 date: 2024-02-28 date: 2024-02-28 name: Hillel Yaffe Medical Center class: OTHER_GOV briefSummary: Evidence shows that anti-fat attitudes and weight stigma are prevalent among healthcare professionals and may affect treatment decisions regarding patients with obesity. The present study aimed to examine the presence of anti-fat attitudes and weight stigma among orthopedic surgeons and their correlation to the therapeutic approach to patients with obesity. In this cross-sectional survey, 150 orthopedic surgeons will complete a web-based questionnaire. the questionnaire is based on Antifat Attitudes Questionnaire (AFA), developed by Crandall in 1994. In addition, the questionnaire will include a questionnaire developed by Bocquier in 200521 to explore weight stigma among physicians. conditions: Weight Stigma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 150 type: ACTUAL name: cross sectional survey measure: anti fat attitudes measure: Weight stigma measure: Therapeutic approach sex: ALL minimumAge: 25 Years maximumAge: 72 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hillel Yaffe Medical Center city: Hadera zip: 38000 country: Israel lat: 32.44192 lon: 34.9039 hasResults: False |
<|newrecord|> nctId: NCT06282263 id: 1292 briefTitle: The Effect of the Awareness Development Program on Suicide Prevention for Oncology Nurses acronym: RCT overallStatus: COMPLETED date: 2023-05-25 date: 2023-11-02 date: 2023-11-02 date: 2024-02-28 date: 2024-02-28 name: Sevda Ozturk class: OTHER briefSummary: The goal of this clinical trial is to investigate the effect of the Awareness Development Programme on Suicide Prevention for Oncology Nurses on the levels of knowledge, stigma and perception of efficacy towards suicide in oncology nurses. The main questions it aims to answer are: |
1. At the end of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology and at the end of the 3-month follow-up, is there a difference between the knowledge levels of nurses about suicide according to the pre-programme and control group? |
2. At the end of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology and at the end of the 3-month follow-up, is there a difference between the perception of efficacy levels of nurses regarding suicide according to the pre-programme and control group. |
3. At the end of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology and at the end of the 3-month follow-up, is there a difference between the stigma levels of nurses towards suicide according to the pre-programme and control group. |
4. Is there a significant relationship between the levels of knowledge about suicide, perception of efficacy regarding suicide, and stigma towards suicide in the pre-test and post-test measurements of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology. |
5. Is there a significant relationship between the levels of knowledge about suicide, perception of efficacy regarding suicide, and stigma towards suicide in the pre-test-follow-up test measurements of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology. |
Participants will participate the Awareness Development Programme on Suicide Prevention for Oncology Nurses. Oncology Nurses are expected to complete the pre-test, post-test and follow-up tests. |
Researchers will compare control group to see if effect of "the Awareness Development Programme on Suicide Prevention" conditions: Suicide Prevention conditions: Nurses studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study was a pre-test, post-test, follow-up design and control group intervention study conducted to examine the effect of "Awareness Development Programme on Suicide Prevention for Oncology Nurses" on oncology nurses' knowledge, stigma and perception of efficacy regarding suicide risk management. primaryPurpose: OTHER masking: NONE count: 86 type: ACTUAL name: "Awareness Development Program on Suicide Prevention for Oncology Nurses" measure: the Literacy of Suicide Scale measure: Efficacy Perception Scale For Suicide Risk Management measure: The Stigma of Suicide Scale sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hacettepe University city: Ankara zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False |
<|newrecord|> nctId: NCT06282250 id: in progress briefTitle: Seeing the Light: Early Intervention in People at Risk for Bipolar Disorder overallStatus: RECRUITING date: 2024-05 date: 2025-06 date: 2025-12 date: 2024-02-28 date: 2024-04-11 name: Geestelijke Gezondheidszorg Eindhoven (GGzE) class: OTHER briefSummary: In the current study, the feasibility, acceptability and effectivity of a new add-on early intervention program for individuals at risk for the development of bipolar disorder is evaluated. This intervention program entails psycho-education, light and lifestyle therapy in combination with Imagery focused Cognitive Therapy (ImCT). The program aims to contribute to early intervention by focusing on subclinical mood swings, anxiety symptoms, circadian rhythm and lifestyle factors such as activity level. We hypothesize a relationship between this early intervention and a significant improvement in mood symptoms, anxiety, subjective and objective sleep factors and lifestyle variables. Also, the feasibility, acceptability and associations with clinical improvement of symptoms will be studied. |
Additionally, in a separate validation study, data will be collected to validate a new instrument for the early detection of those at risk for bipolar disorders. The Semistructured Interview of At Risk Bipolar States (SIBARS) (Fusar-Poli et al., 2022) will be translated and validated in a Dutch sample, in cooperation with its creators, Prof. Dr. P. Fusar-Poli and colleagues. conditions: Bipolar Disorder conditions: Mood Swing conditions: Prodromal Symptoms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Bright light therapy + Psycho-education + Imagery focused Cognitive Therapy name: Blue-light blocking glasses + Psycho-education + Imagery focused Cognitive Therapy name: Psycho-education + Imagery focused Cognitive Therapy measure: Change in depressive symptom scores on the IDS-SR measure: Change in hyperactive symptom scores on the ASRM measure: Change in anxiety symptom scores on the BAI measure: Change in sleep quality subjective rating on 11-point Likert scale measure: Change in activity levels subjective rating on 11-point Likert scale sex: ALL minimumAge: 16 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Geestelijke Gezondheidszorg Eindhoven (GGzE) status: RECRUITING city: Eindhoven state: Noord-Brabant zip: 5626ND country: Netherlands name: Else Treffers, MSc role: CONTACT phone: +31622559192 email: else.treffers@ggze.nl lat: 51.44083 lon: 5.47778 hasResults: False |
<|newrecord|> nctId: NCT06282237 id: 2022.143 briefTitle: Clinical Evaluation, Motor Performance and Quality of Life in Patients Affected by Soft Tissue Sarcomas, Undergoing Surgical Treatment: Observational Study acronym: 1206 overallStatus: RECRUITING date: 2023-07-01 date: 2025-07-01 date: 2026-07-01 date: 2024-02-28 date: 2024-02-28 name: Fondazione Policlinico Universitario Campus Bio-Medico class: OTHER name: Fondazione Don Carlo Gnocchi Onlus briefSummary: The main aim of the study is evaluate quality of life and motor performance of patients with soft tissue sarcomas undergoing surgical treatment and post-operative rehabilitation treatment. |
Primary objectives: |
* Identification of clinical characteristics and motor damage after surgery for soft tissue sarcomas; |
* Impact of perioperative treatments and surgery on the quality of life of patients with soft tissue sarcomas; |
* Impact of post-operative rehabilitation treatment on quality of life and recovery of motor activity The primary endpoint will be the improvement in the Toronto Extremity Salvage Score (TESS) between T1 (post-surgery) and T3 (at the end of rehabilitation treatment). |
Secondary endpoints will be: |
1. the evolution over the various timepoints of the selected rating scales (Toronto Extremity Salvage Score, Musculoskeletal Tumor Society Rating Scale, Numerical Rating Scale, Brief Pain Questionnaire, Douleur Neuropathique en 4 Questions, Leeds Assessment of Neuropathic Symptoms and Signs Scale, European Organization for Research and Treatment of Cancer, Quality-of-Life Questionnaire (QLQ)-C30, Short Form Health Survey 36); |
• The change in walking performance before and after the rehabilitation treatment. conditions: Sarcoma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 13 type: ESTIMATED name: survey measure: Improvement in the Toronto Extremity Salvage Score (TESS) measure: Pain evaluation measure: Motor performance evaluation measure: Evaluation of Quality of Life measure: Pain evaluation measure: Pain evaluation measure: Evaluation of Quality of Life sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Campus Biomedico status: RECRUITING city: Roma zip: 00128 country: Italy name: Sergio Valeri, MD role: CONTACT phone: 06225411626 email: s.valeri@policlinicocampus.it lat: 41.89193 lon: 12.51133 hasResults: False |
<|newrecord|> nctId: NCT06282224 id: XMFHIIT-2023SL066 briefTitle: Application of Augmented Reality Neuronavigation in Transnasal Endoscopic Skull Base Surgery overallStatus: NOT_YET_RECRUITING date: 2024-03-11 date: 2025-01-11 date: 2026-01-11 date: 2024-02-28 date: 2024-02-28 name: The First Affiliated Hospital of Xiamen University class: OTHER briefSummary: "For lesions in the skull base, including meningiomas, chordomas and pituitary tumors, endoscopic surgery has replaced traditional microscopes as the mainstream procedure. Although neurosurgeons can enlarge the surgical area using a neuroendoscope, it does not provide any information on the morphology and location of anatomical structures beneath visible surfaces. Due to the complex anatomical relationships of adjacent structures in the skull base, lesions occurring here are often located deep within anatomy that is difficult to fully expose and remove with endoscopic surgery alone. Especially when dealing with larger tumors that surround major arteries and nerves, limited visibility at surface level can easily damage blood vessels or nerves causing complications such as bleeding during or after surgery, deformities or functional impairments. The purpose of this study is to explore how augmented reality (AR) technology can highlight important anatomical structures in a neuroendoscope's field of view to optimize surgical visibility beyond what is possible with just an endoscope alone. This will make it easier for surgeons to distinguish deeper anatomical structures and reduce intraoperative and postoperative complications associated with endoscopic surgery." conditions: Pituitary Neoplasms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 10 type: ESTIMATED name: Performing endoscopic transnasal skull base surgery with AR-integrated endoscope measure: Postoperative Recovery of Transnasal Surgery measure: Postoperative complication sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06282211 id: CHASE 005 briefTitle: the Efficacy and Safety of Ondansetron Oral Soluble Pellicles overallStatus: RECRUITING date: 2024-02-20 date: 2024-03-01 date: 2024-12-29 date: 2024-02-28 date: 2024-02-28 name: The First Affiliated Hospital of Xinxiang Medical College class: OTHER briefSummary: The name of this prospective study is a multicenter, open-label, randomized controlled clinical study of the efficacy and safety of Ondansetron Oral Soluble Pellicles for the prevention of delayed nausea and vomiting induced by highly emetogenic chemotherapy. conditions: Nausea and Vomiting studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 184 type: ESTIMATED name: Ondansetron Oral Soluble Pellicles measure: Incidence and severity of delayed vomiting in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups measure: Incidence and severity of delayed nauseating in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups measure: Incidence and severity of nausea/vomiting in patients on days 1-4 after chemotherapy in both groups measure: Incidence of adverse events and serious adverse reactions throughout the study period sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Keya Zhi status: RECRUITING city: Weihui state: None Selected zip: 453100 country: China name: Yana Zhang role: CONTACT phone: 15093230340 email: Drzhangyana@hotmail.com lat: 34.79333 lon: 108.93833 hasResults: False |
<|newrecord|> nctId: NCT06282198 id: UCHCEU-13/02/24 briefTitle: Consequences on the Gait Pattern of Patients With Distal Femur Megaprostheses acronym: IMU-DFM overallStatus: RECRUITING date: 2018-02-01 date: 2024-06-01 date: 2024-06-01 date: 2024-02-28 date: 2024-02-28 name: Cardenal Herrera University class: OTHER briefSummary: The primary aim of this study is to compare spatiotemporal gait parameters between participants with distal femur tumor prostheses and healthy individuals without prostheses. conditions: Distal Femoral Musculoskeletal Tumors studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 90 type: ESTIMATED measure: Gait Symmetry index measured in percentage (%) measure: Sagittal range of movement of the knee measured with a goniometer measure: Muscular strength sex: ALL minimumAge: 16 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Universidad CEU Cardenal Herrera status: RECRUITING city: Valencia country: Spain name: JF Lisón, PhD role: CONTACT lat: 39.46975 lon: -0.37739 hasResults: False |
<|newrecord|> nctId: NCT06282185 id: CanisiusWH briefTitle: SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapy acronym: Superman overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-05-01 date: 2024-02-28 date: 2024-02-28 name: Canisius-Wilhelmina Hospital class: OTHER briefSummary: The goal of this single blind placebo-controlled intervention study is to examine the impact of a supervised training program on disease-related quality of life and physical fitness in patient with advanced prostate cancer compared to usual care. The main question\[s\] it aims to answer are: |
* What is the impact of exercise on quality of life |
* What is the impact of exercise on physical fitness |
Participants will have an individual training program with supervised training by physiotherapists. |
Researchers will compare with usual care to see if advice about exercise has significant less effect than an supervised training program. conditions: Prostatic Neoplasms conditions: Metastasis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled trial with an intervention arm and an usual care group primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: In a single blinded (investigators blinded to group allocation) randomized controlled pilot, conducted in the CWZ, 20 patients with advanced prostate cancer will be randomized across: 1) supervised training program for twelve weeks + usual care + advice about exercise, or 2) usual care + advice about exercise. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Physiotherapy measure: change of quality of life assessed with EPIC26 (0-100 points) measure: change of quality of life assessed with EPIC26 (0-100 points) measure: change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale) measure: change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale) measure: change of physical fitness in maximum uptake of oxygen in ml/kg/min measure: change of physical fitness in maximum uptake of oxygen in ml/kg/min measure: change of physical fitness in fat percentage measure: change of physical fitness in fat percentage measure: change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes)) measure: change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes)) sex: MALE minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06282172 id: BTL-785_CTUS1600 briefTitle: Histological Evaluation of BTL-785F Device's Effect on Submental Subcutaneous Adipose Tissue overallStatus: COMPLETED date: 2023-07-25 date: 2023-10-31 date: 2023-12-18 date: 2024-02-28 date: 2024-02-28 name: BTL Industries Ltd. class: INDUSTRY briefSummary: This study aims to evaluate the safety and effectiveness of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of subcutaneous submental fat. conditions: Fat Burn studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 8 type: ACTUAL name: Treatment with BTL-785-7 measure: Investigation of the effect of the BTL-785F device (with BTL-785-7 applicator) on submental subcutaneous fat tissue. measure: Investigation of post-treatment adipocyte apoptosis measure: Incidence of Treatment-related Adverse Events measure: Comfort Evaluation Assessed by Therapy Comfort Questionnaire sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Schweiger Dermatology PC, Research Division city: Hackensack state: New Jersey zip: 07601 country: United States lat: 40.88593 lon: -74.04347 hasResults: False |
<|newrecord|> nctId: NCT06282159 id: DNTH103-MG-201 briefTitle: A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC) acronym: MAGIC overallStatus: RECRUITING date: 2024-02-23 date: 2025-12 date: 2027-12 date: 2024-02-28 date: 2024-04-22 name: Dianthus Therapeutics class: INDUSTRY briefSummary: The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia gravis (gMG). conditions: Myasthenia Gravis, Generalized studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: DNTH103 name: Placebo measure: Incidence, severity, and relationship of TEAEs (including treatment discontinuation due to adverse events [AEs]) [Time Frame: Baseline (Day 1) to Safety Follow-Up Visit (up to Week 40)] measure: Incidence, severity, and relationship of adverse events of special interest (AESI) measure: Number of participants with changes from baseline in ECG parameters measure: Number of participants with changes in clinical laboratory values over time measure: Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) scale score measure: Change from baseline in Quantitative Myasthenia Gravis (QMG) scale score measure: Serum concentrations of DNTH103 measure: Change from baseline in complement total blood test (CH50) measure: Antidrug antibody (ADA) levels against DNTH103 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bradenton Research Center status: RECRUITING city: Bradenton state: Florida zip: 34205 country: United States name: Gloria Carlbert role: CONTACT email: gloriacarlbert@bradentonresearch.com lat: 27.49893 lon: -82.57482 facility: Texas Neurology status: RECRUITING city: Dallas state: Texas zip: 75206 country: United States name: Haley Rucker role: CONTACT email: hrucker@texasneurology.com lat: 32.78306 lon: -96.80667 facility: West Texas Neurology Clinic status: RECRUITING city: Lubbock state: Texas zip: 79414 country: United States name: Christie Long role: CONTACT email: research@westtexasneurologyclinic.com lat: 33.57786 lon: -101.85517 hasResults: False |
<|newrecord|> nctId: NCT06282146 id: 2024P000252 briefTitle: Testing a Transdiagnostic TMS Treatment Target acronym: T5 overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2026-04-01 date: 2024-02-28 date: 2024-02-28 name: Brigham and Women's Hospital class: OTHER briefSummary: The goal of this clinical trial is to test a new brain stimulation treatment target for individuals with depression plus at least one additional psychiatric disorder. The main question is to understand the safety profile of a non-invasive form of brain stimulation called accelerated intermittent theta burst stimulation when it is targeting the posterior parietal cortex. Additional questions focus on whether this stimulation improves symptoms of depression and other psychiatric disorders as well as whether this stimulation changes brain function. conditions: Major Depressive Disorder conditions: Depression conditions: Psychiatric Disorder conditions: Mood Disorders conditions: Mental Disorder conditions: Anxiety Disorders conditions: OCD conditions: PTSD studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 10 type: ESTIMATED name: transcranial magnetic stimulation measure: Tolerability as measured by incidence of side effects on an accelerated TMS sensations and adverse events questionnaire measure: Feasibility as measured by number of the 50 treatments completed measure: Montgomery-Åsberg Depression Rating Scale (MADRS) measure: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision, Level 1 Self-Rated Cross-Cutting Symptom Measure (DSM-5-XC) measure: World Health Organization Disability Assessment Schedule II (WHODAS 2.0) measure: Beck Depression Inventory (BDI) measure: Beck Anxiety Inventory (BAI) measure: Adult Attention Deficit/Hyperactivity Disorder Self-Report Scale (AARS) measure: Clinical Global Impression Scale (CGI) measure: Illness Intrusiveness Rating Scale (IIRS) measure: Perceived Stress Scale (PSS) measure: Positive and Negative Symptom Scale (PANSS) measure: Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) measure: Social Readjustment Rating Scale (SRRS) measure: Yale Brown Obsessive-Compulsive Scale (Y-BOCS) measure: Temperament and Character Inventory, Revised 140-item measure: Emotional Conflict Resolution Test measure: Learning, Multi-Source Interference Task (MSIT) measure: Penn Emotion Recognition Task (ER-40) measure: Death Suicide IAT measure: Young Mania Rating Scale (YMRS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06282133 id: 2024-1862 briefTitle: Behavioural Experiments for Generalized Anxiety in Adolescents - Pilot Study acronym: EC-II-Ado-P overallStatus: RECRUITING date: 2024-02-01 date: 2024-07-01 date: 2025-01-01 date: 2024-02-28 date: 2024-02-28 name: Universite du Quebec en Outaouais class: OTHER briefSummary: Generalized Anxiety Disorder (GAD) is a chronic condition characterized by excessive and uncontrollable worry and anxiety. In adolescents, this condition can seriously impact their development, academic performance, and social relationships. In Canada, 3 to 4% of the population (between 0.9% and 2.7% among adolescents) suffers from GAD at any given time in their lives. These young individuals experience a reduced quality of life and are at risk for numerous medical conditions, as well as additional psychological issues. Research suggests that both pharmacological and psychological approaches are effective in treating GAD in the short term. However, psychological treatments appear to offer the greatest long-term benefits. There are a number of effective psychological treatments for GAD, most of which fall under cognitive-behavioural therapy (CBT) adapted for this age group. |
In the 1990s, a group of Canadian researchers developed a CBT protocol for GAD that included four components. Data from six clinical trials in adults suggest that one of the four components is particularly important for treatment success: exposing oneself to uncertainty rather than avoiding it in daily life. In other words, learning to tolerate and manage uncertainty seems to be the key to reducing worry and anxiety. |
Given this discovery, researchers developed a new treatment that exclusively targets intolerance to uncertainty and then adapted it for adolescents: Behavioural Experiments for Intolerance to Uncertainty in Adolescents (EC-IIA). The aim of the current pilot study is to test the effectiveness of EC-IIA in adolescent individuals. A total of 8 participants with a primary diagnosis of GAD will receive EC-IIA and will be evaluated at 4 different times ranging from pre-treatment to a 6-month follow-up. Conditions will be compared in terms of treatment efficacy and mechanisms. Researchers will also examine predictors of change during the 6 months following treatment. The proposed study will produce data on the effectiveness and mechanisms of a treatment for GAD that is less costly, less complex, and easier to disseminate than currently available treatments. conditions: Generalized Anxiety Disorder conditions: Adolescent - Emotional Problem studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open trial primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: Behavioural Experiments for Intolerance of Uncertainty measure: Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5) measure: Worry and Anxiety Questionnaire (WAQ) measure: Penn State Worry Questionnaire (PSWQ) measure: Beck Anxiety Inventory (BAI) measure: Beck Depression Inventory-II (BDI-II) measure: Intolerance of Uncertainty Scale (IUS) measure: Safety Behaviors Questionnaire (SBQ) measure: Treatment Acceptance and Adherence Scale (TAAS) measure: Working Alliance Inventory (WAI) sex: ALL minimumAge: 14 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Universite du Quebec en Outaouais status: RECRUITING city: Gatineau state: Quebec zip: J8X 3X7 country: Canada name: Sylvain C Lemay, B.A. role: CONTACT phone: +1 819-595-3900 phoneExt: 2501 email: sylvainclaude.lemay@uqo.ca lat: 45.47723 lon: -75.70164 hasResults: False |
<|newrecord|> nctId: NCT06282120 id: CSPC-DNY-BTC briefTitle: Efficacy and Safety of Irinotecan Liposome Injection Combined With 5-FU/LV± Immunotherapy in First-line Gemsitabine + Immunoprogressive Patients With Metastatic Biliary Tract Cancer overallStatus: RECRUITING date: 2024-01-01 date: 2025-01-05 date: 2026-01-01 date: 2024-02-28 date: 2024-02-28 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER name: CSPC Ouyi Pharmaceutical Co., Ltd. briefSummary: The goal of this clinical trial is to test in biliary tract cancer patients . The main questions it aims to answer are: |
* To evaluate the efficacy of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line gemsitabine + immunoprogressive metastatic biliary tract cancer |
* To evaluate the safety of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line gemsitabine + immunoprogressive metastatic biliary tract cancer This study intends to use liposomal irinotecan combined with 5-FU/LV± immunotherapy for second-line treatment of advanced biliary tract cancer that has progressed after gemsitabine + immunotherapy to evaluate the efficacy and safety of this regimen, with a view to providing better treatment options for second-line patients with advanced biliary tract cancer. conditions: Metastatic Biliary Tract Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Irinotecan Hydrochloride Liposome Injection ；Fluorouracil ；Leucovorin；immunotherapy measure: Progression Free Survival measure: Overall Survival measure: Response rates determined by the investigator according to the RECIST(Response Evaluation Criteria in Solid Tumors) v1.1 measure: EORTC-QLQ (European Organization for Research and Treatment of Cancer - Quality of life Questionnaire) C30 (version 3.0) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Cancer Hospital Airport Hospital status: RECRUITING city: Tianjin state: Tianjin zip: 300000 country: China name: Huikai Li, Doctor role: CONTACT phone: 18622228639 email: vianvianvip@163.com name: Xihao Zhang, Master role: CONTACT phone: 15510801035 email: zxh15510801035@163.com lat: 39.14222 lon: 117.17667 hasResults: False |
<|newrecord|> nctId: NCT06282107 id: BiSAAE-RHT briefTitle: Effectiveness and Safety of BiSAAE for Resistant Hypertension. overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2025-06-30 date: 2026-12-31 date: 2024-02-28 date: 2024-02-28 name: First Affiliated Hospital of Chengdu Medical College class: OTHER briefSummary: Hypertension is a common problem, affecting \>1.1 billion people worldwide. Unfortunately, fewer than one in five treated patients with hypertension have their blood pressure (BP) under control. The increasing number of people with uncontrolled BP despite the use of three or more antihypertensive agents at optimal or maximally tolerated doses, with one of those agents preferably being a diuretic has been described as the resistant hypertension (RH). Achieving BP control is essential because patients with hypertension who have uncontrolled BP have significantly higher rates of all-cause, cardiovascular, heart disease and cerebrovascular disease mortality compared to normotensive individuals, whereas mortality risk in patients with well-controlled BP does not differ from that in normotensive individuals. There are a number of potential factors that contribute to the suboptimal control of hypertension, including medication non-adherence and prescribing inertia. This highlights the limitations of purely pharmacological approaches for the effective management of hypertension. In fact, the activation of the renin-angiotensin-aldosterone system (RAAS) and sympatho-adrenomedullary system play a pathogenic role in triggering and sustaining RH. Superselective adrenal arterial embolization (SAAE) is a catheter-based percutaneous transluminal procedure which selectively injects ethanol into adrenal artery to ablate part of the adrenal gland for suppression of excessive aldosterone and catecholamines. Over the last decade, unilateral SAAE has emerged as a potential treatment option for patients with primary aldosteronism. Whether this approach can be extrapolated to patients with RH is unclear. We thus set out to perform a randomized trial to compare the safety and efficacy of bilateral SAAE with antihypertensive medications in treating RH. conditions: Resistant Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 72 type: ESTIMATED name: BiSAAE name: traditional triple antihypertensive treatment measure: Change of 24-h average systolic blood pressure measure: Change of 24-h average systolic blood pressure measure: Change of 24-h average systolic blood pressure measure: Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure measure: Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure measure: Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure measure: Change of home systolic and diastolic pressure measure: Change of home systolic and diastolic pressure measure: Change of home systolic and diastolic pressure measure: Difference in the change of office systolic and diastolic pressure between the intervention and control group measure: Difference in the change of office systolic and diastolic pressure between the intervention and control group measure: Difference in the change of office systolic and diastolic pressure between the intervention and control group measure: Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group measure: Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group measure: Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group measure: Change of plasma aldosterone measure: Change of plasma aldosterone measure: Change of plasma aldosterone measure: Change of plasma cortisol measure: Change of plasma cortisol measure: Change of plasma cortisol measure: Change of plasma renin measured measure: Change of plasma renin measured measure: Change of plasma renin measured measure: Change of liver enzymes measure: Change of liver enzymes measure: Change of liver enzymes measure: Change of kidney function measure: Change of kidney function measure: Change of kidney function measure: Change of fasting blood glucose measure: Change of fasting blood glucose measure: Change of fasting blood glucose measure: Change of lipids profiles measure: Change of lipids profiles measure: Change of lipids profiles measure: Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD) measure: Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD) measure: Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD) measure: Change of 24-h urine microalbumin measure: Change of 24-h urine microalbumin measure: Change of 24-h urine microalbumin measure: Change of 24-h urine creatinine measure: Change of 24-h urine creatinine measure: Change of 24-h urine creatinine measure: Change of echocardiography parameters (LVEF) measure: Change of echocardiography parameters (LVEF) measure: Change of echocardiography parameters (LVEF) measure: Change of carotid intima-media thickness measure: Change of carotid intima-media thickness measure: Change of carotid intima-media thickness sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06282094 id: LUX briefTitle: ViSiGi LUX Bariatric Sizing and Calibration System overallStatus: RECRUITING date: 2024-01-26 date: 2024-03 date: 2024-03 date: 2024-02-28 date: 2024-03-13 name: Boehringer Labs LLC class: INDUSTRY briefSummary: This study investigates the new ViSiGi LUX. conditions: Bariatric Surgery Candidate studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Physician Feedback sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: WellSpan status: RECRUITING city: York state: Pennsylvania zip: 17405 country: United States name: Faiz Shariff role: CONTACT lat: 39.9626 lon: -76.72774 hasResults: False |
<|newrecord|> nctId: NCT06282081 id: ML 45098 briefTitle: Serum Neurofilament Light in Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2027-03-01 date: 2024-02-28 date: 2024-02-28 name: Dent Neuroscience Research Center class: OTHER name: Genentech, Inc., a subsidiary of F. Hoffman-La Roche AG name: Monogram Biosciences (LabCorp Specialty Testing Group) briefSummary: This prospective cohort study is designed to characterize the utility of sNfL as a biomarker in clinical practice. This study also aims to understand how access to sNfL measures affects patient and clinician knowledge of their disease status and capture how this may have the potential to influence clinical decision-making. Level of disability, cognitive changes, fatigue, depression, and quality of life to detect clinical and subclinical worsening will be measured. While there is strong evidence in support of sNfL as a potential biomarker, literature regarding the application of sNfL in a real-world clinical practice setting is lacking. Understanding the utility of this test to clinicians and patients as a biomarker of MS disease activity is essential. Additionally, the optimum sampling frequency in clinical practice should be investigated to further elucidate its practicality. Given recent advances in the treatment of MS, there is increasing need for convenient and accessible measures of treatment efficacy. conditions: Multiple Sclerosis conditions: Relapsing Remitting Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 42 type: ESTIMATED name: Serum Neurofilament Light measure: Evaluate the utility of sNfL levels to aid with clinical decision-making by examining clinicians' understanding of patient's clinical status before sNfL results are received vs. after sNfL results are received measure: Evaluate the utility of sNfL levels to aid with clinical decision-making by examining clinicians' opinion as to how sNfL results could guide clinical practice measure: Describe the optimal sNfL sampling frequency by capturing frequency of unscheduled clinician-ordered sNfL measurements. measure: Describe the optimal sNfL sampling frequency by capturing reason for unscheduled clinician-ordered sNfL measurements. measure: Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale. measure: Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale. measure: Describe patient demographics measure: Describe patient comorbidities measure: Describe patient concomitant medications measure: Describe patient MS medications measure: Describe patient reasons for MS medication changes measure: Describe patient MS relapses including date of relapse measure: Describe patient MS relapses including clinical findings measure: Describe patient MS relapses including radiologic findings measure: Describe patient MS relapses including severity measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. measure: Explore patient attitudes towards sNfL measurements by capturing patients' understanding of their disease before sNfL results are received vs. after sNfL results are received via a structured questionnaire. measure: Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire. measure: Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire. measure: Compare sNfL levels after initiation of a new MS disease-modifying therapy (DMT; when patient is treated with a DMT) vs. prior to MS DMT initiation (when patient is not treated with any DMT) where available. measure: Compare sNfL levels at scheduled sampling time points between patients initiating any new MS DMT vs. patients who do not change MS DMT where available. measure: Compare sNfL levels in patients who have a clinical or radiologic relapse during the study vs. patients who do not. measure: Describe changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available. measure: Describe changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available. measure: Describe changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available. measure: Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available. measure: Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available. measure: Describe changes in sNfL levels with magnetic resonance imaging disease activity where available. measure: Describe changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available. measure: Compare changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available. measure: Compare changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available. measure: Compare changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available. measure: Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available. measure: Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available. measure: Compare changes in sNfL levels with magnetic resonance imaging disease activity where available. measure: Compare changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available. measure: Correlate changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available. measure: Correlate changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available. measure: Correlate changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available. measure: Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available. measure: Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available. measure: Correlate changes in sNfL levels with magnetic resonance imaging disease activity where available. measure: Correlate changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06282068 id: CS2-23178 briefTitle: AI Determine Malignancy of GGO on Chest CT overallStatus: ENROLLING_BY_INVITATION date: 2024-03-01 date: 2026-02-28 date: 2026-02-28 date: 2024-02-28 date: 2024-02-28 name: Chung Shan Medical University class: OTHER briefSummary: Research Objectives To use AI computer-aided detection software to assist physicians in reading CT scans of lung nodules, providing auxiliary diagnostic tools for medical decision-making. The software can mark nodule locations and related information during routine physician reading. This study will obtain prospective consent to use patient CT images for software reading and compare with clinical physician diagnosis, in order to enhance software training and improve recognition of lung lesions for early diagnosis and treatment. |
Study Design Collect CT images of untreated lung nodules 4-30mm in size that are scheduled for surgery. No limits on age, gender, disease type, with image resolution \<2.5mm. AI and clinicians will judge nodule characteristics separately. Surgical resection followed by comparison with pathology reports will evaluate diagnostic accuracy. |
Study Procedures A double-blinded method will be used. AI and physicians will record nodules as likely benign or malignant separately. After surgical resection, the lesions will undergo pathological staging and the diagnostic accuracy of both groups will be compared. |
Expected Results Compare the diagnostic accuracy of AI and clinicians to improve AI training quality, achieve early diagnosis and treatment goals, and provide patients with better medical care quality. |
Monitoring Method AI and clinicians will read separately, adhering to shared decision making without affecting patient access to diagnosis and treatment. |
Keywords: lung nodules, early lung cancer, artificial intelligence, chest CT, minimally invasive surgery, lung image analysis software conditions: Lung Nodules, Early Lung Cancer, Artificial Intelligence, Chest CT, Minimally Invasive Surgery, Lung Image Analysis Software studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: AI computer-aided detection software measure: The accuricy of the diagnostic power. sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chung Shan Medical University Hospital city: Taichung state: South zip: 402 country: Taiwan lat: 24.1469 lon: 120.6839 hasResults: False |
<|newrecord|> nctId: NCT06282055 id: TIMES briefTitle: Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes acronym: TIMES overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-09-01 date: 2026-03-01 date: 2024-02-28 date: 2024-02-28 name: DCB Research AG class: OTHER briefSummary: Standardized longitudinal data collection of diabetes management relevant factors in women with T1D (insulin requirements (insulin pump or smart pen data), glucose variability (CGM data), nutritional information, and menstrual cycle information (cycle tracking app, LH tests, and premenstrual symptoms)) to identify categories of cycle trajectories. conditions: Diabetes Mellitus, Type 1 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: No intervention measure: Identify different trajectories of insulin sensitivity throughout the menstrual cycle measure: Total daily Insulin dose throughout the menstrual cycle measure: Coefficient of glucose variability throughout the menstrual cycle measure: Estimated insulin sensitivity throughout the menstrual cycle measure: Glycaemic profile (mean glucose, time in range, time above range, time below range, coefficient of variability) throughout the menstrual cycle measure: Correlations between insulin sensitivity trajectories and confounders sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06282042 id: EMCAMI briefTitle: Early Transcatheter Mitral Valve Repair After Myocardial Infarction acronym: EMCAMI overallStatus: NOT_YET_RECRUITING date: 2024-06-17 date: 2027-06-16 date: 2028-06-16 date: 2024-02-28 date: 2024-04-24 name: Fundación para la Investigación Biosanitaria del Principado de Asturias class: OTHER name: Meditrial Europe Ltd. briefSummary: To explore the impact of early transcatheter edge-to-edge repair of acute functional mitral regurgitation after myocardial infarction on the combined incidence of death and heart-failure associated hospitalisations at one-year follow-up, and quality of life and LV remodelling at two-year follow-up. conditions: Acute Mitral Regurgitation studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, multicentre, randomised, open-label, comparative effectiveness clinical trial for the treatment of clinically significant functional mitral regurgitation within 60 days after acute myocardial infarction, who are treated per standard of care and who have been determined by the site's local heart team as inappropriate or too high risk for mitral valve surgery. primaryPurpose: TREATMENT masking: NONE count: 250 type: ESTIMATED name: Early transcatheter edge-to-edge mitral valve repair (TEER). name: MitraClip name: Optimal medical treatment measure: All-cause death or Cumulative Heart Failure hospitalizations sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shaare Zedek Medical Center city: Jerusalem state: Jerusalen zip: 9103102 country: Israel name: Mony Shuvy role: CONTACT name: Dr. Mony Shuvy role: PRINCIPAL_INVESTIGATOR lat: 31.76904 lon: 35.21633 facility: Rabin Medical Center city: Petah tikva zip: 4941492 country: Israel name: Leor Perl role: CONTACT name: Dr. Leor Perl role: PRINCIPAL_INVESTIGATOR lat: 32.08707 lon: 34.88747 facility: Sheba Medical Center city: Ramat Gan country: Israel lat: 32.08227 lon: 34.81065 facility: Civil Hospital of Brescia city: Brescia zip: 25123 country: Italy name: Marianna Adamo role: CONTACT name: Dra. Marianna Adamo role: PRINCIPAL_INVESTIGATOR lat: 45.53558 lon: 10.21472 facility: San Raffaele Hospital city: Milano zip: 20132 country: Italy name: Cosmo Godino role: CONTACT name: Dr. Cosmo Godino role: PRINCIPAL_INVESTIGATOR name: Dr. Francesco Maisano role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: Policlínico San Donato city: San Donato Milanese zip: 20097 country: Italy name: Francesco Bedogni role: CONTACT name: Dr. Francesco Bedogni role: PRINCIPAL_INVESTIGATOR lat: 45.41047 lon: 9.26838 facility: Amsterdam University Medical Center city: Amsterdam zip: 1081 HV country: Netherlands name: R. Delewi role: CONTACT name: Dr. R. Delewi role: PRINCIPAL_INVESTIGATOR lat: 52.37403 lon: 4.88969 facility: Amphia Hospital city: Breda zip: 4818 CK country: Netherlands name: B. van der Branden role: CONTACT name: Dr. B. van der Branden role: PRINCIPAL_INVESTIGATOR lat: 51.58656 lon: 4.77596 facility: Catharina Ziekenhuis Hospital city: Eindhoven zip: 5623 EJ country: Netherlands name: P. Tonino role: CONTACT name: Dr. P. Tonino role: PRINCIPAL_INVESTIGATOR lat: 51.44083 lon: 5.47778 facility: Leiden University Medical Center city: Leiden zip: 2333 ZA country: Netherlands name: F. van der Kley role: CONTACT name: Dr. F. van der Kley role: PRINCIPAL_INVESTIGATOR lat: 52.15833 lon: 4.49306 facility: Maastricht University Medical Center city: Maastricht zip: 6229 HX country: Netherlands name: P.A. Vriesendorp role: CONTACT name: Dr. P.A. Vriesendorp role: PRINCIPAL_INVESTIGATOR lat: 50.84833 lon: 5.68889 facility: St. Antonius Hospital city: Nieuwegein zip: 3435 CM country: Netherlands name: L. Timmers role: CONTACT name: Dr. L. Timmers role: PRINCIPAL_INVESTIGATOR lat: 52.02917 lon: 5.08056 facility: Erasmus University Medical Center city: Rotterdam zip: 3015 GD country: Netherlands name: N. van Mieghem role: CONTACT name: Dr. N. van Mieghem role: PRINCIPAL_INVESTIGATOR lat: 51.9225 lon: 4.47917 facility: Isala Hospital city: Zwolle zip: 8025 AB country: Netherlands name: R. Hermanides role: CONTACT name: Dr. R. Hermanides role: PRINCIPAL_INVESTIGATOR lat: 52.5125 lon: 6.09444 facility: Hospital Universitario Marqués de Valdecilla city: Santander state: Cantabria zip: 39008 country: Spain name: Jose María de la Torre, MD, PhD role: CONTACT name: Dr. Jose María de la Torre, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.46472 lon: -3.80444 facility: Hospital Universitario Doctor Negrin city: Las Palmas de Gran Canaria state: Las Palmas zip: 35010 country: Spain name: Pedro Martín, MD, PhD role: CONTACT name: Dr. Pedro Martín, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 28.09973 lon: -15.41343 facility: Hospital Álvaro Cunqueiro city: Vigo state: Pontevedra zip: 36312 country: Spain name: Rodrigo Estévez-Loureiro, MD, PhD role: CONTACT name: Dr. Rodrigo Estévez-Loureiro, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.23282 lon: -8.72264 facility: Hospital General Universitario Dr. Balmis city: Alicante zip: 03010 country: Spain name: Juan M. Ruiz-Nodar, MD, PhD role: CONTACT name: Juan M. Ruiz-Nodar, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 38.34517 lon: -0.48149 facility: Hospital de la Santa Creu i Sant Pau city: Barcelona zip: 08025 country: Spain name: Dabit Arzamendi, MD, PhD role: CONTACT name: Dabit Arzamendi, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Hospital Universitario Vall d'Hebrón city: Barcelona zip: 08035 country: Spain name: Bruno García del Blanco, MD, PhD role: CONTACT name: Dr. Bruno García del Blanco, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Hospital Clínic Barcelona city: Barcelona zip: 08036 country: Spain name: Xavier Freixa Rofastes, MD, PhD role: CONTACT name: Dr. Xavier Freixa Rofastes, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Hospital Universitario Reina Sofía city: Córdoba zip: 14004 country: Spain name: Manuel Pan Álvarez, MD, PhD role: CONTACT name: Dr. Manuel Pan Álvarez, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.89155 lon: -4.77275 facility: Hospital Universitario Ramón y Cajal city: Madrid zip: 28034 country: Spain name: Ángel Sánchez-Recalde, MD, PhD role: CONTACT name: Dr. Ángel Sánchez-Recalde, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Hospital Clínico Universitario San Carlos city: Madrid zip: 28040 country: Spain name: Luis Nombela, MD, PhD role: CONTACT name: Dr. Luis Nombela, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Puerta de Hierro city: Madrid zip: 28222 country: Spain name: María del Trigo, MD, PhD role: CONTACT name: Dra. María del Trigo, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Virgen de la Victoria city: Málaga zip: 29010 country: Spain name: Juan H. Alonso Briales, MD, PhD role: CONTACT name: Dr. Juan H. Alonso Briales, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 36.72016 lon: -4.42034 facility: Hospital Clínico Universitario de Valladolid city: Valladolid zip: 47003 country: Spain name: Ignacio Amat-Santos, MD, PhD role: CONTACT name: Dr. Ignacio Amat-Santos, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.65518 lon: -4.72372 hasResults: False |
<|newrecord|> nctId: NCT06282029 id: I-2720-0018-0003 briefTitle: ACT-group for Stroke Survivors (Pilot Study) overallStatus: RECRUITING date: 2024-02-01 date: 2024-05 date: 2024-05 date: 2024-02-28 date: 2024-02-28 name: Bielefeld University class: OTHER name: Bielefeld Young Researchers' Fund briefSummary: The goal of this clinical pilot trial is to test the feasibility, acceptance and preliminary efficacy of an adapted group psychotherapy manual in stroke survivors with psychological stress. The main questions it aims to answer are: |
* Is the group therapy feasible? |
* Is the group therapy accepted by stroke survivors and therapists? |
* Are there first indications on the efficacy of the group therapy to improve mental health? |
Participants will take part in 8 weekly group therapy sessions of 90 minutes each. conditions: Stroke conditions: Intracerebral Hemorrhage conditions: Depressive Symptoms conditions: Anxiety conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This pilot study includes a pre-/post test of a small intervention sample without control group. primaryPurpose: OTHER masking: NONE count: 12 type: ESTIMATED name: Group Therapy measure: Drop-out rate measure: Session adherence measure: Homework completion measure: Completion of outcome measures measure: Treatment fidelity measure: Group therapy session questionnaire - patients (Zoubek, 2013; Plain German) measure: Group therapy session questionnaire - therapists (Zoubek, 2013; Plain German) measure: Acceptance and Action Questionnaire-Acquired Brain Injury (Sylvester, 2011; Plain German) measure: Depression and Anxiety Stress Scales-21 (Lovibond, 1995; Plain German) measure: Valuing Questionnaire (Smout, 2014; Plain German) measure: Self-as-context scale (Zettle, 2018; Plain German) measure: Patient Health Questionnaire-9 (Kroenke, 2001; Plain German) measure: Generalized Anxiety Disorder-7 (Spitzer, 2006; Plain German) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Neuropsychological Outpatient Clinic status: RECRUITING city: Bielefeld zip: 33607 country: Germany name: Simon Ladwig, PhD role: CONTACT phone: 017664716035 email: simon.ladwig@uni-bielefeld.de lat: 52.03333 lon: 8.53333 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-12 uploadDate: 2024-02-12T06:57 filename: Prot_SAP_000.pdf size: 260777 hasResults: False |
<|newrecord|> nctId: NCT06282016 id: BKR-2024-001 briefTitle: Risk Factors for Neuroendocrine Neoplasms overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-07 date: 2025-07 date: 2024-02-28 date: 2024-03-06 name: Bavarian Cancer Registry class: OTHER_GOV name: Bavarian Association of Statutory Health Insurance Accredited Physicians briefSummary: Recent studies show an increase in neuroendocrine neoplasms, especially for the digestive tract. Previous studies suggest various risk factors that were observed for various tumor sites, e.g. a family history of cancer, tobacco and alcohol consumption as well as metabolic disorders including diabetes and obesity. A risk factor that has been little studied to date is depressive disorders, which could increase the risk of neuroendocrine neoplasms either independently or through associated risk behaviors and/or antidepressant medication. The aim of this study is to identify risk factors for neuroendocrine neoplasms based on a case-control study in order to better understand the increase of neuroendocrine neoplasms in recent decades. The study is based on a record linkage of data from the Bavarian Cancer Registry and data from the Bavarian Association of Statutory Health Insurance Accredited Physicians. While the data from the Bavarian Cancer Registry enables the identification of neuroendocrine neoplasms on the basis of histopathological findings and thus is the basis for selecting cases, the claims data from the Bavarian Association of Statutory Health Insurance Accredited Physicians provides the source population as well data on diagnoses and thus enables the investigation of risk factors. conditions: Neuroendocrine Neoplasm of Lung conditions: Neuroendocrine Neoplasm of Gastrointestinal Tract (Disorder) studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 7200 type: ESTIMATED name: Case-control study (no intervention) measure: Depression/Persistent mood disorder measure: Obesity measure: Metabolic syndrome measure: Previous malignant neoplasm measure: Alcohol buse measure: Diabetes measure: Ulcerative colitis measure: Crohn disease measure: Allergic rhinitis measure: Asthma measure: Area deprivation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06282003 id: 380-59-10106-21-111/148 briefTitle: Protective Anesthesiological Management Procedure Imposes Control on Respiratory Comlications overallStatus: RECRUITING date: 2023-10-10 date: 2024-06-30 date: 2024-09-30 date: 2024-02-28 date: 2024-02-28 name: Masa Kontic class: OTHER_GOV name: Prof.Dinko Tonković, MD, PhD Head of Department of Anesthesiology, Reanimatology and Intensive Care Medicine and Pain Therapy, University Hospital Centre Zagreb name: Assist. Prof. Slavica Sović, MD, PhD Department of Medical Statistics, Epidemiology and Medical Informatics, School of Public Health Andrija Štampar name: Prof. Goran Šimić, MD, PhD Professor of Neuroscience and Anatomy, Chair, Department of Neuroscience, Croatian Institute for Brain Research, University of Zagreb name: Prof. Anamarija Jazbec, Faculty of Forestry and Wood Technology, University of Zagreb name: Marijan Jedvaj, MD Anesthesiologist and ICU physician (Consultant), Head of Department of Anesthesia and IC, General Hospital Zabok briefSummary: Anesthetic effects, surgery, and invasive mechanical intubation can impair respiratory function during general anesthesia. The risk factors for postoperative pulmonary complications (PPCs) include the type of surgery and duration, ventilation-perfusion discrepancy, and the presence of pain. Mitigating PPCs under anesthesia is a goal, but effective strategies are yet to be defined. Conventional ventilation (CV) procedure uses more inspired oxygen during pre-oxygenation and anesthesia maintenance. The protective lung ventilation (PV) procedure, on the other hand, includes high positive end-expiratory pressure, lung recruitment maneuver, oxygen saturation levels above 94%, lower inspired oxygen levels, and continuous positive airway pressure before the tube is removed. In this study, 56 consecutive patients undergoing abdominal surgery were randomly assigned, with 30 in the CV and 23 in the PV group, while 3 were lost during the follow-up. We concluded that the implementation of protective lung ventilation strategies has the potential to reduce the occurrence of PPCs, recommending these strategies be adopted as the standard practice in general anesthesia. conditions: Well-Being, Psychological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A crossover design should be utilized in addition to the randomization procedure to properly address outcome variability. This study was a prospective, single-center, randomized controlled, patient- and evaluator-blinded clinical investigation with a two-arm parallel design to assess the advantage of the protective (optimized) ventilation procedure (PV group of patients) compared to the conventional (standard) method of lung ventilation (CV) during general anesthesia. primaryPurpose: TREATMENT masking: NONE count: 53 type: ESTIMATED name: The procedure of protective lung ventilation measure: Oxygentation sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: General hospital Zabok status: RECRUITING city: Zabok zip: 49210 country: Croatia name: Maša Kontić, Medical Doctor role: CONTACT phone: 00385 98 97 95 648 email: mkontic.konti@gmail.com lat: 46.02944 lon: 15.915 hasResults: False |
<|newrecord|> nctId: NCT06281990 id: BAUN-SBF-PO-01 briefTitle: Education and Information for Bariatric Surgery Patients overallStatus: COMPLETED date: 2022-12-01 date: 2023-11-01 date: 2024-01-05 date: 2024-02-28 date: 2024-02-28 name: Balikesir University class: OTHER name: The Scientific and Technological Research Council of Turkey briefSummary: The study aimed to investigate the effect of pre-admission education given to bariatric surgery (laparoscopic sleeve gastrectomy) patients on preoperative and postoperative anxiety, postoperative pain, and patient vital signs. conditions: Bariatric Surgeries conditions: Education of Patients studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are two groups in the research: control and intervention groups. primaryPurpose: OTHER masking: DOUBLE maskingDescription: The researcher (YY) provided education in the outpatient clinic. The nurses and surgical team members working in the surgical ward were blinded (FÇ in the research group was blinded). whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 68 type: ACTUAL name: Education measure: Data collection form measure: Visual Analog Scale (VAS) measure: State-Trait Anxiety Inventory (STAI) sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pınar Ongün city: Balıkesir zip: 38000 country: Turkey lat: 39.64917 lon: 27.88611 hasResults: False |
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