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<|newrecord|> nctId: NCT06369272 id: mRNA-1273-P919 briefTitle: Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy overallStatus: COMPLETED date: 2023-03-01 date: 2023-10-20 date: 2023-10-20 date: 2024-04-16 date: 2024-04-16 name: ModernaTX, Inc. class: INDUSTRY briefSummary: The primary objectives of this study are:
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In infants of women exposed to SPIKEVAX during pregnancy, to assess:
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* If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of major congenital malformations (MCMs).
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* If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of adverse neonatal and infant outcomes, specifically neonatal encephalopathy, small for gestational age, respiratory distress in the newborn, and incidence of hospitalization due to infections including coronavirus disease 2019 (COVID-19).
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* In women exposed to SPIKEVAX during pregnancy, to assess whether exposure to SPIKEVAX is associated with an increased prevalence of hypertensive disorders \[e.g., pre-eclampsia, eclampsia, and gestational hypertension\] gestational diabetes, and post-partum hemorrhage; and
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* To assess whether exposure to SPIKEVAX during pregnancy is associated with an increased incidence of stillbirth, preterm birth, and medically attended spontaneous abortion. conditions: Maternal Outcomes conditions: Infant Outcomes conditions: Pregnancy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1192 type: ACTUAL measure: Number of MCMs measure: Number of Adverse Neonatal and Infant Outcomes measure: Number of Participants with Hypertensive Disorders measure: Number of Stillbirths, Preterm Births, and Medically Attended Spontaneous Abortions measure: Demographics: Participant Region of Residence measure: Demographics: Age at LMP measure: Demographics: Number of Overweight or Obese Participants measure: Demographics: Duration of Health Plan Enrolment Prior to Pregnancy measure: Demographics: Calendar Date of the Pregnancy Outcome measure: Demographics: Participant Race and Ethnicity measure: Demographics: Participant Socio-economic Status measure: Healthcare Utilization: Number of Office Visits, Emergency Department Visits, and Hospitalizations measure: Healthcare Utilization: Number of Distinct Medications Used sex: FEMALE minimumAge: 13 Years maximumAge: 49 Years stdAges: CHILD stdAges: ADULT facility: Carelon Research city: Newton state: Massachusetts zip: 02458 country: United States lat: 42.33704 lon: -71.20922 hasResults: False
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<|newrecord|> nctId: NCT06369259 id: 2023-0997 id: NCI-2024-03302 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Open-label Phase 2 Study of Avutometinib (RAF/MEK Clamp) in Combination With Defactinib (FAK Inhibitor) and Cetuximab in Patients With Unresectable, Anti-EGFR-Refractory Advanced Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2026-02-01 date: 2028-02-01 date: 2024-04-16 date: 2024-04-16 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To learn if avutometinib in combination with defactinib and cetuximab can help to control unresectable, anti-EGFR-refractory, advanced colorectal cancer. conditions: Advanced Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: Defactinib name: Cetuximab name: Avutometinib measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77807 country: United States name: Christine Parseghian, MD role: CONTACT name: Christine Parseghian, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06369246 id: 2023-0893 id: NCI-2024-03308 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: PRORAD-5 PROstate RADiation in 5 Fractions: Phase Ib Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2025-09-01 date: 2027-09-01 date: 2024-04-16 date: 2024-04-16 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To look at the safety and effectiveness of stereotactic body radiation therapy (SBRT) in treating advanced or high-risk prostate cancer. conditions: Advanced Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: Stereotactic Body Radiation Therapy measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Comron Hassanzadeh, MD role: CONTACT phone: 713-657-9802 email: cjhassanzadeh@mdanderson.org name: Comron Hassanzadeh, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06369233 id: LNC-MS-002 briefTitle: Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery overallStatus: RECRUITING date: 2024-04-01 date: 2025-02-28 date: 2025-02-28 date: 2024-04-16 date: 2024-04-25 name: L&C Bio class: INDUSTRY name: PROMeDis briefSummary: This study is Interventional, Parallel, Double-blinded, Randomized study. Subjects aged 20 to 70 years who had a Lumbar discectomy or laminectomy, MegaShield-SP® and Guardix-SP Plus will be applied. conditions: Herniation, Disc studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: MegaShield®-SP name: Guardix-SP Plus measure: MRI scar score measure: Oswestry Disability Index(ODI) score measure: Visual Analog Scale(VAS) Back & Leg Pain Score sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eunpyeong ST. Mary's Hospital status: RECRUITING city: Seoul zip: 03312 country: Korea, Republic of name: HyungYul Park role: CONTACT phone: 02-2030-4536 email: matrixbest@naver.com name: HyungYul Kim, Professor role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Severance Hospital status: RECRUITING city: Seoul zip: 03722 country: Korea, Republic of name: Siyoung Park role: CONTACT phone: 2228-2194 email: drspine90@yuhs.ac name: Siyoung Park, Professor role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Gangnam Severance Hospital status: RECRUITING city: Seoul zip: 06273 country: Korea, Republic of name: Jiwon Kwon role: CONTACT phone: 2019-3411 email: KWONJJANNG@yuhs.ac name: Jiwon Kwon, Professor role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Bundang Seoul National University Hospital status: RECRUITING city: Seoul zip: 13620 country: Korea, Republic of name: Hojung Kim role: CONTACT phone: 031-787-7202 email: oshjkim@gmail.com name: Hojung Kim, Professor role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06369220 id: LIA-STI-542 briefTitle: A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2024-10-31 date: 2024-10-31 date: 2024-04-16 date: 2024-04-16 name: Hoffmann-La Roche class: INDUSTRY name: Roche Molecular Systems, Inc briefSummary: This study is designed to assess the comparative clinical utility of the point of care cobas® liat CT/NG/MG to current standard practices in the diagnosis and treatment of urogenital infections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG). conditions: Chlamydia Trachomatis Infection conditions: Neisseria Gonorrhoeae Infection conditions: Mycoplasma Genitalium Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 348 type: ESTIMATED name: cobas® liat CT/NG/MG nucleic acid test name: Standard of Care (SOC): Clinician's Standard Practice measure: Percentage of Participants Given Inappropriate Treatments for All Pathogens Combined (CT, NG, and MG) measure: Percentage of Participants Given Inappropriate Treatment for CT Infection measure: Percentage of Participants Given Inappropriate Treatment for NG Infection measure: Percentage of Participants Given Inappropriate Treatment for MG Infection measure: Mean Satisfaction and Confidence Rating Scores of SOC and POC, According to Healthcare Professionals' Responses to the CSDT Questionnaire measure: Mean Satisfaction Rating Scores of SOC and POC, According to Participants' Responses to the PSDT Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06369207 id: 113454 briefTitle: Investigation of the Transmission Pathways of Reflux in Patients With Chronic Venous Evaluation of Reflux Transmission Pathways in Chronic Venous Insufficiency Patients Secondary to Saphenofemoral Reflux overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-12 date: 2024-02-15 date: 2024-09 date: 2024-04-16 date: 2024-04-22 name: Golestan University of Medical sciences class: OTHER briefSummary: Chronic venous insufficiency (CVI) is one of the most common medical problems in adults that occurs secondary to the reflux of blood through incompetent valves of lower extremity veins. The most common involved valve is the valve located at the saphenofemoral junction. Although the pathway of reflux transmission is not the same in all patients, the removal or ablation of the greater saphenous vein (GSV) is considered a standard treatment in these patients. However, in patients whose reflux is transmitted to branches other than GSV, this treatment leads to the unnecessary destruction of a competent segment of GSV in addition to remaining at least some segments of incompetent veins. So, in this study, the investigators intend to investigate the different pathways of reflux transmission in chronic venous insufficiency patients who are candidates for GSV ablation/stripping because of saphenofemoral junction insufficiency. This cross-sectional study will be conducted with a descriptive-analytical approach. . conditions: Venous Insufficiency studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ACTUAL measure: Determination of reflux transmission pathways in CVI patients with SFJ incompetency measure: Anatomic variations of GSV in CVI patients with SFJ incompetency measure: Prevalence of reflux along GSV main trunk in CVI patients with SFJ incompetency measure: Prevalence of reflux along accessory saphenous veins in CVI patients with SFJ incompetency sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pezhman Kharazm, MD city: Gorgan state: Golestan zip: 4917956808 country: Iran, Islamic Republic of lat: 36.8427 lon: 54.44391 hasResults: False
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<|newrecord|> nctId: NCT06369194 id: POWER5 briefTitle: POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-14 date: 2024-04-15 date: 2024-04-15 date: 2024-04-16 date: 2024-04-19 name: Grupo Español de Rehabilitación Multimodal class: OTHER briefSummary: The main objective of this study is to analyze the impact on five years survival of an enhanced recovery program (PRI) after radical surgery for colorectal cancer. As secondaries objectives, we propose to analyze comparing survival distributions between patient groups (ERAS/no ERAS) and the relationship between the ERAS program and early incorporation into oncology therapies (RIOT).
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It is proposed to review the medical records of oncology patients included in POWER 1 (as already foreseen in that study), with the aim of performing a 5-year follow-up.
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To create comparable treatment and control groups, the Propensity Index method will be used. To study each variable, multivariate regression will be used. Kaplan-Meier will be used for survival and the log-rank test for comparisons. Significance will be considered if p \<0.05 (two tails). conditions: Colorectal Surgery conditions: Critical Pathways conditions: Enhanced Recovery After Surgery conditions: Retrospective Studies conditions: Chemotherapy, Adjuvant studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 847 type: ACTUAL name: Colorectal Surgery measure: Overall Survival measure: Disease-free survival measure: Time to disease recurrence measure: Time to return to intended oncologic treatment (RIOT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Virgen de los Lirios de Alcoy city: Alcoy state: Alicante country: Spain lat: 38.70545 lon: -0.47432 facility: Hospital General Universitario de Elche city: Elche state: Alicante country: Spain lat: 38.26218 lon: -0.70107 facility: Hospital Universitario Central de Asturias city: Oviedo state: Asturias country: Spain lat: 43.36029 lon: -5.84476 facility: Hospital de Igualada city: Igualada state: Barcelona country: Spain lat: 41.58098 lon: 1.6172 facility: Hospital de Sant Joan Despí Moisès Broggi city: Sant Joan d'Espi state: Barcelona country: Spain lat: 41.36718 lon: 2.0574 facility: Fundación Hospital del Espíritu Santo city: Santa Coloma De Gramenet state: Barcelona country: Spain lat: 41.45152 lon: 2.2081 facility: Hospital Universitari Mútua Terrassa city: Terrassa state: Barcelona country: Spain lat: 41.56667 lon: 2.01667 facility: Hospital Universitario de Vic city: Vic state: Barcelona country: Spain lat: 41.93012 lon: 2.25486 facility: Hospital General Universitario de Castellón city: Castellon de la Plana state: Castellón country: Spain lat: 39.98567 lon: -0.04935 facility: Hospital Universitario Puerta de Hierro city: Majadahonda state: Madrid country: Spain lat: 40.47353 lon: -3.87182 facility: Hospital Universitario de Móstoles city: Mostoles state: Madrid country: Spain lat: 40.32234 lon: -3.86496 facility: Hospital Universitario Rafael Méndez city: Lorca state: Murcia country: Spain lat: 37.67119 lon: -1.7017 facility: Hospital Costa del Sol city: Marbella state: Málaga country: Spain lat: 36.51543 lon: -4.88583 facility: Hospital Nuestra Señora del Prado city: Talavera de la Reina state: Toledo country: Spain lat: 39.96348 lon: -4.83076 facility: Hospital Universitario Araba city: Alava country: Spain lat: 43.36057 lon: -6.19946 facility: Hospital General Universitario de Alicante city: Alicante country: Spain lat: 38.34517 lon: -0.48149 facility: Hospital Clínic Universitat de Barcelona city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Hospital del Mar city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Hospital Universitario Santa Creu i Sant Pau city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Hospital Universitario Vall d´Hebrón city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Hospital General Universitario de Ciudad Real city: Ciudad Real country: Spain lat: 38.98626 lon: -3.92907 facility: Hospital de Galdakao-Usansolo city: Galdakao country: Spain lat: 43.23333 lon: -2.83333 facility: Hospital Universitario Insular de Gran Canaria city: Las Palmas de Gran Canaria country: Spain lat: 28.09973 lon: -15.41343 facility: Hospital Universitario de Gran Canaria Doctor Negrín city: Las Palmas country: Spain lat: 28.58232 lon: -16.16555 facility: Hospital de La Princesa city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario 12 de Octubre city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Infanta Leonor city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Ramón y Cajal city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario San Carlos city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Complejo Hospitalario de Salamanca city: Salamanca country: Spain lat: 40.96882 lon: -5.66388 facility: Hospital Universitario Donostia city: San Sebastián country: Spain lat: 43.31283 lon: -1.97499 facility: Hospital Universitario Virgen Macarena city: Sevilla country: Spain lat: 37.38283 lon: -5.97317 facility: Consorcio Hospital General Unidersitario de Valencia city: Valencia country: Spain lat: 39.46975 lon: -0.37739 facility: Hospital Clínico Universitario de Valencia city: Valencia country: Spain lat: 39.46975 lon: -0.37739 facility: Hospital Clínico de Valladolid city: Valladolid country: Spain lat: 41.65518 lon: -4.72372 facility: Hospital Universitario Miguel Server city: Zaragoza country: Spain lat: 41.65606 lon: -0.87734 hasResults: False
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<|newrecord|> nctId: NCT06369181 id: NET 2020 briefTitle: Neuroendocrine Transformation in RB1/TP53 Inactivated NSCLC overallStatus: RECRUITING date: 2021-01-01 date: 2027-12-31 date: 2028-12-31 date: 2024-04-16 date: 2024-04-23 name: Fudan University class: OTHER briefSummary: Histology transformation from non-small cell lung cancer (NSCLC) to neuroendocrine carcinomas (NEC), especially from epidermal growth factor receptor (EGFR) mutant lung adenocarcinoma (LADC) to small cell lung cancer (SCLC), is widely recognized as a rare mechanism for NSCLC to confer tyrosine kinase inhibitors (TKIs) resistance. The probability of its occurrence is about 3-14% in NSCLC patients who are resistant to TKI treatment. In addition to EGFR mutations, NSCLC patients carrying ALK/ROS1 mutations and receiving corresponding TKI treatment may also experience NEC transformation(NET).
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In a previous study \[Pubmed ID: 35609408\], the investigators demonstrated that NET also develops in NSCLCs without TKI targets or treatments. This phenomenon could be under-recognized, because re-biopsy was less frequently performed in these patients. The investigators had also shown that p53/Rb inactivation might correlated with NET and should be considered for NET risk prediction. In another retrospective studies, it was found that NSCLC patients with RB1/TP53 dual inactivation mutations had a significantly higher probability of NEC pathological transformation than those without RB1/TP53 inactivation mutations (43 times higher than those without mutations). Therefore, the subgroup of NSCLC patients with tumor suppressor gene RB1/TP53 dual inactivation might have elevated risk for NET.
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In this study, the investigators proposed to prospectively follow up NSCLC patients with dual RB1/TP53 inactivation (approximately 5% of the total NSCLC). Through prospective and systematic collection of baseline pathological information, clinical treatment process, and imaging data, and as much as possible, repeat pathological biopsies will be performed during disease progression. conditions: Neuroendocrine Carcinoma conditions: Non-small Cell Lung Cancer conditions: Histology Transformation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: neuroendocrine transformation rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Zhengfei Zhu, MD role: CONTACT phone: +86 18017312901 email: fuscczzf@163.com lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06369168 id: Kliniken Essen-Mitte briefTitle: Auricular Acupuncture and Hot Flashes During Adjuvant Endocrine Therapy acronym: OhrHit overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2024-11-20 date: 2025-11-20 date: 2024-04-16 date: 2024-04-23 name: Kliniken Essen-Mitte class: OTHER name: Karl and Veronica Carstens Foundation briefSummary: With this clinical trial we investigate whether auricular acupuncture during adjuvant endocrine therapy has an improving effect on hot flashes, which are often perceived as psychologically and physically stressful in self-assessment of women with breast cancer.
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Empirical studies indicate that body acupuncture has positive effects on hot flashes. As auricular acupuncture offers a number of advantages over body acupuncture, a three-armed randomised controlled research design is being used to investigate whether hot flashes caused by endocrine therapy are also reduced by ear acupuncture. Balanced ear acupuncture will be compared with NADA ear acupuncture in terms of efficacy and effectiveness. In addition, the effects of the two forms of therapy on the patients' individual quality of life, fatigue, stress perception and sleep quality will be analysed. conditions: Hot Flashes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 99 type: ESTIMATED name: auricular acupuncture measure: subscale somato-vegetative symptoms of the Menopause Rating Scale (MRS) measure: Menopause Rating Scale (MRS) total score measure: Psychological symptoms and urogenital symptoms subscales of the MRS measure: functional assessment of cancer therapy - breast (FACT-B) measure: perceived stress questionnaire (PSQ) measure: insomnia severity index (ISI) measure: big five inventory (BFI) measure: Expected effect of the respective intervention on a 100mm visual analogue scale measure: intensity and degree of impairment due to hot flashes on a 100mm visual analogue scale measure: adverse events (AEs) sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06369155 id: 24-061 briefTitle: Azenosertib in Uterine Serous Carcinoma: Biomarker Study overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-01-31 date: 2027-01-31 date: 2024-04-16 date: 2024-04-16 name: Joyce Liu, MD class: OTHER name: National Cancer Institute (NCI) name: Zentalis briefSummary: This research study is being done to investigate how Azenosertib affects tumor cells of persistent or recurrent uterine serous carcinoma.
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The name of the study drug involved in this study is:
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-Azenosertib (a type of Wee1 inhibitor) conditions: Uterine Serous Carcinoma conditions: Uterine Carcinoma conditions: Uterine Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Azenosertib measure: Percentage Change in Replication Fork Speed in Overall Response measure: Percentage Change in Replication Fork Speed in 6 Month Progression Free Survival (PFS6) measure: Overall Response Rate (ORR) measure: 6-month Progression-Free Survival (PFS6) measure: Clinical Benefit Rate (CBR) measure: Median Duration of Overall Response (DOR) measure: Median Progression-Free Survival (PFS) measure: Grade 3-5 Treatment-related Toxicity Rate sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02215 country: United States name: Joyce Liu, MD, MPH role: CONTACT phone: 617-632-5269 email: joyce_liu@dfci.harvard.edu name: Joyce Liu, MD, MPH role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Dana-Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States name: Joyce Liu, MD, MPH role: CONTACT phone: 617-632-5269 email: joyce_liu@dfci.harvard.edu name: Joyce Liu, MD, MPH role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06369142 id: GE IDE No. L00123 briefTitle: Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy acronym: ISAR-WAVE overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2027-04-30 date: 2027-07-31 date: 2024-04-16 date: 2024-04-16 name: Deutsches Herzzentrum Muenchen class: OTHER name: Gemeinsamer Bundesaussschuss name: EvidentIQ Germany GmbH name: Monitoring Services GmbH name: Institute of AI and Informatics in Medicine Technical University of Munich briefSummary: The clinical trial is intended to evaluate the efficacy, safety and economic benefit of coronary lithotripsy compared to other additional procedures (cutting or super high pressure balloon angioplasty, ablative procedures) in lesion preparation and interventional treatment of severely calcified coronary stenoses. conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The study participant as well as the follow-up physicians and site personal are blinded. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 666 type: ESTIMATED name: Intravascular lithotripsy (IVL) name: Standard non-IVL methods measure: Combined endpoint of major cardiac and cerebrovascular events measure: Mortality measure: Cardiac mortality measure: Non-fatal myocardial infarction measure: Non-fatal stroke measure: Clinically indicated target vessel revascularization measure: Definite stent thrombosis measure: Clinically indicated non-target vessel revascularization measure: Hospitalization due to acute coronary syndrome measure: Symptoms of coronary heart disease (CHD): physical health status measure: Symptoms of CHD: mental health status measure: Bleeding during index hospitalization or ≤30 days (BARC 3-5) measure: Procedural failure (failed application of study-related additional procedure, final TIMI flow <3, >30% residual stenosis, vessel perforation, stent loss, stent delivery failure) measure: Medical costs (index hospitalization and costs for re-hospitalization due to acute coronary syndrome) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Deutsches Herzzentrum München city: Munich state: Bavaria zip: 80636 country: Germany name: Salvatore Cassese, MD, PHD role: CONTACT phone: 0049891218 phoneExt: 2764 email: cassese@dhm.mhn.de name: Salvatore Cassese, MD, PDH role: PRINCIPAL_INVESTIGATOR lat: 48.13743 lon: 11.57549 hasResults: False
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<|newrecord|> nctId: NCT06369129 id: CEBD-CU-2024-06-16 briefTitle: Accuracy& Orbital Volume Using Patient Specific Titanium Implant Vs Zirconia for Orbital Floor Reconstruction overallStatus: RECRUITING date: 2024-04-06 date: 2025-08 date: 2025-08 date: 2024-04-16 date: 2024-04-17 name: Cairo University class: OTHER briefSummary: Comparative study used to assess if the patient specific zirconia implant will provide better accuracy, intraoperative adaptability, precise orbital volume and soft tissue reaction with more cost effectiveness than the patient specific titanium implants in orbital floor reconstruction after blow out fractures . conditions: Blow-Out Fractures conditions: Orbital Fractures conditions: Orbital Floor Fracture conditions: Orbital Trauma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized clinical trial.
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* Parallel group study.
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* A trial will be carried out in hospital of Oral and Maxillofacial surgery department - Faculty of Oral and Dental Medicine - Cairo University .
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* Equal randomization : participants with equal probabilities for intervention.
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* Positive controlled : Both groups receiving treatment. primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Orbital floor reconstruction with Patient Specific Zirconia Implant name: Orbital floor reconstruction with Patient Specific Titanium Implant measure: Orbital Volume measure: Accuracy of the patient specific implant in the orbital floor reconstruction measure: Cost effectiveness measure: Patient satisfaction sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Cairo University status: RECRUITING city: Cairo zip: 11511 country: Egypt name: OLA A. ELMORSY, PHD role: CONTACT phone: 00201141234877 email: dr.ola.elmorsy@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06369116 id: CLS-017B id: HSTAR012 type: OTHER domain: HSTAR Programme id: WRHI071 type: OTHER domain: Ezintsha briefTitle: Trial of Hepatitis C Self-Testing in the Hands of Untrained Lay Users overallStatus: RECRUITING date: 2023-10-12 date: 2023-11-17 date: 2024-04-22 date: 2024-04-16 date: 2024-04-16 name: bioLytical Laboratories class: INDUSTRY briefSummary: This is a controlled study intended to evaluate the usability, label comprehension and performance of the INSTI® HCV Self Test in the hands of untrained lay users using fingerstick blood, with instructions for use specifically designed for a lay person who has not used any hepatitis C rapid self test prior to the study and to assess "lay" users ability to comprehend key concepts and information provided on the outside of the pouch and in the accompanying Instructions for Use. Comprehension will be assessed without product familiarization (demonstration/training) by a healthcare professional. conditions: Hepatitis C studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Participants are recruited and enrolled to conduct INSTI HCV Self Test and then participate in the usability portion of the study. primaryPurpose: SCREENING masking: SINGLE whoMasked: CARE_PROVIDER count: 1400 type: ESTIMATED name: INSTI HCV Self Test measure: Clinical sensitivity and specificity of INSTI HCV Self Test measure: To assess the usability and label comprehension of the INSTI HCV Self Test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ezintsha, a division of Wits Health Consortium (Pty) Ltd status: RECRUITING city: Parktown zip: 2193 country: South Africa name: Vanessa Tiyamike Msolomba role: CONTACT phone: +27 74 830 9063 email: vmsolomba@ezintsha.org lat: -26.18205 lon: 28.02671 hasResults: False
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<|newrecord|> nctId: NCT06369103 id: FMBSUREC/03032024/Fakhry briefTitle: The Sedative Effects of Dexmedetomidine VS Propofol During Peribulbar Anesthesia in Patients Undergoing Vitrectomy Surgery overallStatus: RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-05-01 date: 2024-04-16 date: 2024-04-16 name: Beni-Suef University class: OTHER briefSummary: The aim of the work to compare the Sedative Effects of Dexmedetomidine and Propofol during peribulbar anesthesia in patients undergoing vitrectomy surgery on hemodynamic, respiratory parameters, recovery profile, analgesic effects, post-operative cognitive function, patients satisfaction and adverse events. conditions: Patient conditions: Satisfaction studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 420 type: ESTIMATED name: Dexmedetomidine name: Propofol measure: Patient satisfaction measure: Visual analogue scale sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beni Suef University Hospital status: RECRUITING city: Banī Suwayf state: Beni Suef zip: 62814 country: Egypt name: Dina M Fakhry, MD role: CONTACT phone: 0201289998680 email: dina_fakhry_91@yahoo.com name: Dina M Fakhry, MD role: CONTACT phone: +201289998680 email: dina_fakhry_91@yahoo.com lat: 29.07441 lon: 31.09785 hasResults: False
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<|newrecord|> nctId: NCT06369090 id: JP/1/2013 briefTitle: Effect of Breast Size on the Electrical Impedance Tomography Measurement overallStatus: COMPLETED date: 2013-11-01 date: 2014-05-31 date: 2014-05-31 date: 2024-04-16 date: 2024-04-16 name: Czech Technical University in Prague class: OTHER briefSummary: Twenty-two healthy female volunteers were monitored using electrical impedance tomogprahy (EIT) in two different situations. First, with electrode belt placed over the breast tissue and second, with the electrode belt under the breast tissue. The EIT measurement was performed with adjunct spirometric measurement. The changes of regional ventilation related to the breast tissue and the size of breast tissue were evaluated. conditions: Effect of Breast Tissue on EIT Lung Monitoring studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Monitoring of 22 subjects, each subject was measured twice with electrode belt in two different positions. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 22 type: ACTUAL name: Electrical impedance tomography (EIT) measure: Regional ventilation changes possibly caused by the breast tissue measure: Female subjects enrollment in EIT studies and clinical applications sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Biomedical Engineering, Czech Technical University in Prague city: Kladno zip: 27201 country: Czechia lat: 50.14734 lon: 14.10285 hasResults: False
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<|newrecord|> nctId: NCT06369077 id: CTGlaucoma1 briefTitle: How Much Does Reduced Dosing of Latanoprost and Dorzolamide-timolol Affect Pressure? overallStatus: RECRUITING date: 2024-04 date: 2024-07 date: 2024-07 date: 2024-04-16 date: 2024-04-17 name: CT Glaucoma Associates class: OTHER briefSummary: IOP effect of half-dose latanoprost dorzolamide-timolol will be compared to full dose. Further comparison will be made timolol-brimonidine-dorzolamide-bimatoprost. Dry eye effects of the different treatments will be assessed. conditions: Glaucoma, Open-Angle conditions: Glaucoma; Drugs studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Subjects will have baseline IOP measurements (7-9 am and 3-5 pm) after using using latanoprost every other day and dorzolamide-timolol every morning. They will then randomly be assigned in phase 2 to either: double the frequency to latanoprost daily and dorzolamide-timolol twice daily; or use every morning compounded timolol-brimonidine-dorzolamide-bimatoprost. IOP measurements will be repeated 3 weeks after using the phase 2 medications. For phase 3, subjects will use the treatment to which they were not assigned in phase 2, and IOP measurements will again be repeated 3 weeks later.
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At each study visit, dry eye signs will be assessed and brief dry eye survey will be administered. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Technician measuring IOP and assessing dry eye is masked regarding phase 2 and phase 3 crossover assignment order. whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: dorzolamide/timolol measure: intraocular pressure measure: dry eye sex: ALL minimumAge: 25 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CT Glaucoma Associates status: RECRUITING city: Norwalk state: Connecticut zip: 06851 country: United States name: Peter E Libre, MD role: CONTACT phone: 203-853-2020 email: pel3@cumc.columbia.edu name: Faria Mahjabin, BA role: CONTACT email: faria.mahjabin@quinnipiac.edu lat: 41.1176 lon: -73.4079 hasResults: False
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<|newrecord|> nctId: NCT06369064 id: 2023A02707-38 briefTitle: Continuous Veno-venous Hemodialysis and Continuous Veno-venous Hemodiafiltration on Urea Reduction Rate in Intensive Care Patient acronym: CompEER overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2026-08-15 date: 2026-08-15 date: 2024-04-16 date: 2024-04-16 name: Centre Hospitalier Universitaire de Nīmes class: OTHER briefSummary: In patients requiring renal replacement therapy (RRT) in the intensive care unit (ICU), continuous techniques are predominantly using due to better hemodynamic tolerance. The most employed techniques in ICU are continuous venovenous hemodiafiltration (CVVHDF) and continuous venovenous hemodialysis (CVVHD).
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To our knowledge, there are no prospective studies comparing the efficiency of these two techniques with the same dose of dialysis (and the same filter).
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In the CompEER study, we aim to compare the efficiency of CVVHD and CVVHDF on urea reduction rate in intensive care patients with acute kidney injury.
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The research hypothesis is that CVVHD citrate technique is as effective as CVVHDF heparin technique for urea reduction and provides prolonged and stable clearance, facilitating antibiotic management during RRT. conditions: Acute Kidney Injury conditions: Continuous Renal Replacement Therapy conditions: Intensive Care Unit studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: CVVHD Dialysis parameters name: CVVHDF Dialysis parameters measure: urea reduction rate (URR) measure: Creatinine clearance at H24 measure: Urea clearance at H24 measure: Urea clearance at H48 measure: ICU Mortality measure: Mortality at Day 28 measure: Organ failure-free days at Day 28 measure: Hypokalemia at Day 28 measure: Hypophosphatemia at Day 28 measure: Hypomagnesemia at Day 28 measure: Hyperkalemia at Day 28 measure: Medical Cost sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Nimes city: Nîmes zip: 30029 country: France name: Claire Roger, MD, PhD role: CONTACT email: claire.roger@chu-nimes.fr name: Claire Roger, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Aurèle Buzancais, MD role: SUB_INVESTIGATOR name: Sylvain Garnier, MD role: SUB_INVESTIGATOR lat: 43.83333 lon: 4.35 hasResults: False
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<|newrecord|> nctId: NCT06369051 id: YSEmploy briefTitle: Supporting Self-employment in Young Adults With Stroke overallStatus: RECRUITING date: 2023-01-01 date: 2025-12-31 date: 2026-12-31 date: 2024-04-16 date: 2024-04-16 name: Chinese University of Hong Kong class: OTHER briefSummary: This project will investigate the effects of an 8-week theory-driven online/hybrid Self-employment Skill Building Intervention on the rate of self-employment, self-efficacy, life satisfaction, and psychosocial outcomes among working-age stroke survivors. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 156 type: ESTIMATED name: Self-employment support intervention measure: Self-employment rate measure: Self-efficacy measure: Life satisfaction measure: Emotional well-being measure: Community reintegration sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Non-government organisations status: RECRUITING city: Hong Kong country: Hong Kong name: Suzanne Lo role: CONTACT phone: 85239434485 email: suzannelo@cuhk.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False
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<|newrecord|> nctId: NCT06369038 id: CUP3222024 briefTitle: Children's Drawing as a Projective Tool to Assess Dental Anxiety overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-12-30 date: 2025-12-30 date: 2024-04-16 date: 2024-04-16 name: Cairo University class: OTHER briefSummary: The aim in this study is to compare the results of anxiety measurement of the child using the CD:H scale with the long-used Face,Legs,Activity,Cry and Consolability scale (FLACC scale) and pulse oximeter reading, to see if the drawing alone can be a reliable tool to predict the child's behaviour before the dental procedure. conditions: Dental Anxiety studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 138 type: ESTIMATED name: observation of level of dental anxiety in children measure: FLAAC behavioral scale sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06369025 id: PreVio briefTitle: Preventing Physical and Emotional Violence by Parents and Teachers in Public Schools in Tanzania (ICC-T/ICC-P_Tanz) acronym: PreVio overallStatus: RECRUITING date: 2024-04-15 date: 2025-02-28 date: 2025-07-30 date: 2024-04-16 date: 2024-04-17 name: Bielefeld University class: OTHER name: Technical University of Munich name: Dar es Salaam University College of Edcuation name: Muhimbili University of Health and Allied Sciences briefSummary: More than 1.7 billion children worldwide experience violence in their upbringing. Prevalence rates are particularly high in Africa. Toxic stress associated with violence impacts the developing brain. This affects behavioral, social, and emotional functioning of children. The present project will test an intervention that simultaneously aims at reducing violence against children at home and at school. Within the project, (1) the feasibility, acceptability, and cost-effectiveness of the Intervention and (2) the initial effectiveness of reducing parental and teacher violence will be tested. To this end, a mixed-methods two-arm school-based pilot cluster-randomized controlled trial (CRCT) in Tanzania will be conducted.
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One unique and novel aspect of this project is to test a school-based intervention approach that targets both teachers and parents. A school-based approach including both teachers and parents has the following key advantages: (1) parents of different social, economic, and educational backgrounds can be motivated to participate and (2) using the existing infrastructure of schools reduces costs and will later improve the scalability of the program. The project is bringing together the global health, development economy, and psychological perspectives to promote our collaboration within the German global health community and with research and policy partners in Tanzania. conditions: Violence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 1840 type: ESTIMATED name: Interaction Competencies with Children measure: Reduction of children's exposure to emotional and physical violence by parents and teachers measure: Reduction of parents' or teachers' use of emotional and physical violence measure: Change of parents' and teachers' attitudes towards emotional and physical violence measure: Improvement of children's mental health measure: Increase of children's quality of life measure: Improvement of school climate measure: Reduction of children's perceived stress measure: Reduction of parents' and teachers' perceived stress measure: Improvement of teachers' decision making measure: Improvement of teachers' self-efficacy sex: ALL minimumAge: 9 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Daressalaam University College of Education status: RECRUITING city: Daressalam country: Tanzania name: Mabula Nkuba, Dr. role: CONTACT name: Eliud Kabelege role: CONTACT lat: -6.82349 lon: 39.26951 hasResults: False
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<|newrecord|> nctId: NCT06369012 id: Rania Gamal briefTitle: Management of Abnormal Uterine Bleeding overallStatus: RECRUITING date: 2024-03-01 date: 2024-09-01 date: 2024-09-30 date: 2024-04-16 date: 2024-04-16 name: Egymedicalpedia class: INDUSTRY briefSummary: Abnormal uterine bleeding "AUB" describes all abnormal forms of menstrual bleeding which may result from several causes including anovulation, problems related to pregnancy, infections, vaginal and cervical abnormalities, uterine pathologies including benign and malignant tumors, coagulopathies, endocrine disorders, trauma, foreign bodies, systemic diseases and iatrogenic causes. AUB may be clinically presented by menorrhagia, metrorrhagia or menometrorrhagia. It's the most common complaint for the reproductive age females and accounts for 33% of female patients referred to gynecologists conditions: Abnormal Uterine Bleeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 130 type: ESTIMATED name: Mefenamic acid 500 mg measure: Bleeding Control sex: FEMALE minimumAge: 15 Years maximumAge: 45 Years stdAges: CHILD stdAges: ADULT facility: Ain Shams University Hospitals status: RECRUITING city: Cairo country: Egypt name: Rania Gamal Anwar, M.D role: CONTACT phone: +201283262383 email: dr.raniagamal2015@yahoo.com lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06368999 id: EEGCOV briefTitle: Neurophysiological and Neuropsychological Evalution in Healthcare Workers acronym: EEGCOV overallStatus: COMPLETED date: 2020-05-27 date: 2020-12-21 date: 2021-01-09 date: 2024-04-16 date: 2024-04-16 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: The goal of this observational study is to compare in participant population the effect of stress condition on cerebral EEG activity Participants will do an 8 minutes EEG registration. Researchers will compare EEG activity of heathcare workers. conditions: Stress Disorders, Post-Traumatic studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: study of brain EEG activity primaryPurpose: SCREENING masking: NONE count: 40 type: ACTUAL name: EEG measure: EEG activity sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico city: Milan zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06368986 id: 222420 briefTitle: A Study to Investigate the Effect of Food on the Bioavailability of a Capsid Inhibitor (CAI) in Male and Female Healthy Participants overallStatus: NOT_YET_RECRUITING date: 2024-04-16 date: 2024-06-12 date: 2024-06-12 date: 2024-04-16 date: 2024-04-16 name: ViiV Healthcare class: INDUSTRY briefSummary: The purpose of this study is to evaluate effect of food (in fasted and fed conditions) on the bioavailability of CAI VH4011499. conditions: HIV Infections studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: VH4011499 measure: Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4011499 measure: Area under the plasma drug concentration - time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-tlast) of VH4011499 measure: Maximum observed plasma drug concentration (Cmax) of VH4011499 measure: Time to maximum observed plasma concentration (Tmax) of VH4011499 measure: Number of participants with AEs (Adverse Events), by severity measure: Number of participants with maximum toxicity grade increase from baseline for liver laboratory parameters measure: Change from baseline in liver panel parameters: total bilirubin and direct bilirubin (micromoles per liter) measure: Change from baseline in liver panel parameters: ALT, ALP and AST (International units per liter) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06368973 id: RC16-4-2023 briefTitle: Mechanical Ventilation-Associated Complications and Co-Morbidities in Children Admitted in Pediatric Intensive Care Unit overallStatus: COMPLETED date: 2021-01-01 date: 2023-12-01 date: 2023-12-31 date: 2024-04-16 date: 2024-04-16 name: Benha University class: OTHER briefSummary: The goal of this study was to identify the prevalence of mechanical ventilation-associated complications and co-morbidities in pediatric patients admitted to the PICU of Benha University Hospital, uncover how often these problems occur, their types, factors linked to them and to compare the epidemiology of MV-associated complications. conditions: Mechanical Ventilation Complication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 315 type: ACTUAL measure: Adverse events associated with mechanical ventilation sex: ALL minimumAge: 1 Month maximumAge: 16 Years stdAges: CHILD facility: Benha University Hospital city: Cairo zip: 13511 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06368960 id: BM201-1001 id: CTR20223162 type: REGISTRY domain: National Medical Products Administration briefTitle: BM201 in Combination With Radiotherapy in Patients With Advanced Solid Tumors acronym: BM201-1001 overallStatus: RECRUITING date: 2022-11-07 date: 2024-12-31 date: 2024-12-31 date: 2024-04-16 date: 2024-04-16 name: InnoBM Pharmaceuticals Co., Ltd. class: INDUSTRY briefSummary: This is a non-randomized，open-label，controlled multi-center Phase Ⅰ study to evaluate tolerability, pharmacokinetics, and preliminary efficacy of BM201 injection in combination with radiotherapy in patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors who have failed standard therapy or are unable to receive standard treatment. conditions: Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Radiotherapy name: BM201 injection measure: DLT and MTD measure: Pharmacokinetic (PK) parameters measure: Number of patients with adverse events (AEs) measure: ORR measure: Peripheral blood cytokine profiling in study participants. measure: The variation in peripheral blood tumor biomarker concentrations. measure: Other exploring outcomes sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing Drum Towel Hospital /The Affiliated Hospital of Nanjing University Medical School status: RECRUITING city: Nanjing state: Jiangsu zip: 210008 country: China name: Juan L GCP Director role: CONTACT phone: 800-555-5555 email: njglyygcp@163.com name: Baorui L Chief Physician role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06368947 id: B.30.2.ATA.0.01.00/172 briefTitle: Therapeutic Play on Pain Tolerance and Emotion Regulation in Children overallStatus: RECRUITING date: 2024-03-29 date: 2024-12-29 date: 2026-12-29 date: 2024-04-16 date: 2024-04-17 name: Ataturk University class: OTHER briefSummary: The research is a randomized controlled experimental study. The population of the research will consist of 10-18 year old children who were diagnosed with acute lymphoblastic leukemia and received chemotherapy, who were admitted to the Children's Hematology Clinic of Adana City Training and Research Hospital between 19.05.2024 and 19.05.2025. Therapeutic play sessions will occur over a 4-week period during chemotherapy treatment. conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 66 type: ESTIMATED name: Therapeutic Play measure: Pain Tolerance Scale for Children with Cancer measure: Emotion Regulation Scale for Children and Adolescents sex: ALL minimumAge: 10 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Ataturk University Nursing of Faculty status: RECRUITING city: Erzurum zip: 25240 country: Turkey name: ARZU SARIALİOĞLU, PHD role: CONTACT phone: 04422315795 email: arzu.celebi@atauni.edu.tr lat: 39.90861 lon: 41.27694 hasResults: False
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<|newrecord|> nctId: NCT06368934 id: KY2024-011 briefTitle: Sub-lobectomy for IDH Wild-type and TERT Promoter Mutant Glioblastoma overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2026-12 date: 2027-06 date: 2024-04-16 date: 2024-04-16 name: Huashan Hospital class: OTHER briefSummary: Glioblastoma is recognized as the most common and aggressive form of primary malignant brain tumor, with treatment options that are limited and prognosis that is extremely poor, showing median progression-free survival of 12 months and median overall survival of less than 18 months. Surgical resection plays a critical role in the treatment, with the extent of resection significantly impacting patient outcomes. Historical approaches to surgical resection have evolved, moving from radical strategies to more conservative ones that aim to preserve normal brain function while removing the tumor as completely as possible. Recent studies have suggested that increasing the extent of surgical resection, particularly along the T2 FLAIR border rather than the traditional T1-enhanced border, can significantly improve patient prognosis. There is, however, a lack of consensus on the optimal surgical approach, and the heterogeneity of tumors presents challenges in standardizing surgical strategies. Extended resection has been shown to prolong survival, and novel intraoperative molecular diagnostics have emerged to improve accuracy in tumor classification and prognosis. Building on these advancements, a multicenter, prospective, randomized controlled trial is proposed to evaluate the efficacy of sub-lobectomy in treating IDH wild-type/TERTp-mutant glioblastoma, aiming to improve evidence levels and establish standardized surgical practices for this devastating disease. conditions: Glioma conditions: Glioblastoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Type of study: randomized parallel controlled, open-label, multicenter clinical trial.
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Interventions: the intervention group was to receive frontal, temporal, parietal, and occipital sub-lobotomies that met anatomical criteria, and the control group was to receive imaging total resection (T1-enhanced borders) that met the Response Assessment in Neuro-Oncology (RANO) criteria.
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Randomization The control group and intervention group were equal in size. Following intraoperative pathological diagnosis, participants were randomly assigned using a centralized randomization system known as the Interactive Web Response System (IWRS). Stratification factors included preoperative age brackets of \[18-65\] and (65-80), gender (male or female), and tumor site in the frontal, temporal, parietal, and occipital lobes. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This study employed a single-blind approach whereby the participants were unaware of the kind of surgical resection they were receiving. whoMasked: PARTICIPANT count: 326 type: ESTIMATED name: sub-lobectomy name: imaging total resection measure: Progression-free Survival measure: Overall Survival measure: Postoperative quality of life measure: Adverse effects measure: Cognitive function measure: Language function measure: Limb muscle strength sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hushan Hospital, Fudan University city: Shanghai state: Shanghai zip: 200040 country: China lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06368921 id: VRT106-C01 briefTitle: A Study of Recombinant Oncolytic Virus M1(VRT106) in Patients With Solid Tumors overallStatus: RECRUITING date: 2024-04 date: 2025-09 date: 2025-12 date: 2024-04-16 date: 2024-04-16 name: Guangzhou Virotech Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: To Evaluate the safety and tolerability of single and multiple intratumoral injections of recombinant oncolytic virus M1 (VRT106) in patients with locally advanced/metastatic solid tumors. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: VRT106 measure: Evaluate the safety and tolerability of escalating doses of intratumoral injection of VRT106. measure: Characterize the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels. measure: Examine the biological distribution characteristics and shedding patterns of intratumoral injection of VRT106. measure: Assess the immunogenicity of intratumoral injection of VRT106. measure: Assess the anti-tumor effect of VRT106, including objective response rate (ORR) as efficacy indicators. measure: Assess the anti-tumor effect of VRT106, including disease control rate (DCR) as efficacy indicators. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center status: RECRUITING city: Guangzhou state: Guangdong country: China name: Hongyun Zhao role: CONTACT email: zhaohy@syscc.org.cn lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06368908 id: 6I/2023/3 briefTitle: Transcutaneous Functional Magnetic Muscle Stimulation in Critically Ill acronym: FMS_ICU overallStatus: RECRUITING date: 2023-12-08 date: 2024-10-30 date: 2024-12-30 date: 2024-04-16 date: 2024-04-16 name: General and Teaching Hospital Celje class: OTHER briefSummary: ICU-Acquired weakness (ICU-AW) is a significant complication of critical illness. ICU-AW is common in patients with sepsis, systemic inflammatory response, and mechanically ventilated. It is estimated that around 50% of patients recovering from the primary illness remain in intensive care with characteristic muscle weakness. This leads to dependence on mechanical ventilation, prolonging costly intensive care hospitalization. The myopathy causes persistent functional impairment, endangering patients long after hospital discharge.
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Magnetic stimulation prevents inactivation atrophy of skeletal muscles, as demonstrated in the mobilized limb of rats. Transcutaneous magnetic stimulation of the quadriceps via the femoral nerve is a safe and painless method even when applied to humans.
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In patients with chronic obstructive pulmonary disease (COPD), quadriceps magnetic stimulation increased spontaneous contraction force compared to the control group and improved quality of life. Patients with COPD tolerate quadriceps magnetic stimulation well, as it does not affect oxidative stress in muscles but does increase the size of slow-twitch muscle fibers.
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In intensive care medicine, magnetic stimulation has been primarily used for diagnostic purposes in assessing diaphragm function, peripheral muscle strength assessment, and transcranial electrical stimulation as a diagnostic tool and therapeutic stimulation of brain cells. With the development of modern transcutaneous magnetic stimulators, the possibility arises for their use in intensive care medicine for therapeutic purposes such as preventing critical illness myopathy.
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To date, no research has been conducted on the use and effectiveness of magnetic stimulation of peripheral muscles in critically ill individuals.
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The aim of the study is to investigate the effect of Functional Muscle Magnetic Stimulation (FMS) on the development of ICU-AW. conditions: Critical Illness Myopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: One of legs is randomised to be stimulated by trans-cutaneous functional magnetic stimulation (Arm 1), the other leg is control (Arm 2) primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Transcutaneous Functional Magnetic Muscle Stimulation measure: Measurement of Thickness of Thigh Muscles measure: Measurement of Thigh Circumference measure: Assessment of Muscle Strength and Communication Ability measure: Body composition measurement by bioimpedance- Extracellular water measure: Body composition measurement by bioimpedance- Intracellular water measure: Body composition measurement by bioimpedance- skeletal muscle mass sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: General Hospital Celje status: RECRUITING city: Celje zip: 300 country: Slovenia lat: 46.23092 lon: 15.26044 hasResults: False
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<|newrecord|> nctId: NCT06368895 id: 2188 briefTitle: Fecal Microbiota Transplantation by Oral Capsules for Hepatic Encephalopathy Treatment overallStatus: RECRUITING date: 2021-04-07 date: 2025-06 date: 2025-06 date: 2024-04-16 date: 2024-04-16 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: This interventional study aims to evaluate the safety and efficacy of oral capsule fecal microbiota transplantation (FMT) for treating hepatic encephalopathy refractory to conventional rifaximin and lactulose therapy in patients with liver cirrhosis. Patients diagnosed with hepatic encephalopathy refractory to rifaximin and lactulose therapy will be randomized into three groups. While continuing conventional therapy, the first group receives FMT via colonoscopy and oral capsule administration, the second group receives only oral capsule administration, and the third group serves as a control, receiving only conventional therapy.
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The aims of the study are:
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To evaluate the efficacy and safety of FMT by oral capsules in cirrhotic patients with hepatic encephalopathy refractory to standard therapy.
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To evaluate changes in the gut microbiota composition and in the intestinal and systemic inflammatory condition occurring after FMT and if they can be associated with clinical improvement.
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To evaluate metabolic modifications occurring after FMT and if they can be associated with clinical improvement. conditions: Hepatic Encephalopathy conditions: Dysbiosis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Fecal microbiota transplantation delivery through colonoscopy name: Fecal microbiota transplantation delivery through oral capsules measure: Evaluation of safety of fecal microbiota transplantation by oral capsules in the treatment of cirrhotic patients with hepatic encephalopathy refractory to conventional therapy measure: Evaluation of efficacy of fecal microbiota transplantation by oral capsules in the treatment of cirrhotic patients with hepatic encephalopathy refractory to conventional therapy measure: Evaluation of changes in the gut microbiota composition following the fecal microbiota transplantation measure: Evaluation of changes in the systemic inflammatory following the fecal microbiota transplantation measure: Evaluation of changes in the intestinal inflammatory following the fecal microbiota transplantation measure: Comparison between protein metabolites concentration (ppm) in serum, urine and feces before and after microbiota transplantation measure: Comparison between lipid metabolites concentration (ppm) in serum, urine and feces before and after microbiota transplantation measure: Comparison between carbohydrates metabolites concentration (ppm) in serum, urine and feces before and after microbiota transplantation sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Agostino Gemelli IRCCS status: RECRUITING city: Rome zip: 00168 country: Italy name: Francesca Ponziani, MD role: CONTACT phone: +390630156018 email: comitato.etico@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06368882 id: Yongping _Chen briefTitle: Efficacy and Safety of Antiviral Therapy With Peg-interferon for Chronic Hepatitis B Complicated With Nonalcoholic Fatty Liver Disease（OCEAN PROJECT） overallStatus: RECRUITING date: 2024-01-01 date: 2028-12-31 date: 2028-12-31 date: 2024-04-16 date: 2024-04-16 name: First Affiliated Hospital of Wenzhou Medical University class: OTHER briefSummary: This is a prospective, multicenter, open-label, non-randomized controlled real-world study to explore the efficacy and safety and to accumulate more evidence-based medical data of an antiviral treatment programme for chronic viral hepatitis B with nonalcoholic fatty liver disease.
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A total of 1500 patients with chronic hepatitis B complicated with nonalcoholic fatty liver disease are divided into test group (1000 patients receiving PEG-IFNα-based antiviral therapy (combined NAs or Peg-IFNα monotherapy) and control group（500 patients receiving NAs monotherapy） according to their treatment intention. Laboratory and medical data from specified follow-up points are collected, and adverse events and drug combinations are recorded detailly.
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The primary efficacy indicator is HBsAg clearance at 48 weeks of treatment, and the secondary indicators included: (1) HBsAg clearance at 96 weeks of treatment, (2) Cumulative HBsAg clearance at week 24、120、144、168、192、216 and 240; (3) The improvement of liver function level(ALT, AST, TBIL, etc.), blood lipid (TC, TG, LDL-C, HDL-C, etc.), fasting blood glucose, insulin resistance index (HOMA-IR), controlled attenuation parameter, body mass index , liver stiffness measurement, liver histological fibrosis, FIB-4 index from baseline; (4)Incidence of liver cirrhosis and hepatocellular carcinoma during follow-up.
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The security assessment includes adverse events, vital signs, and imaging. conditions: Nonalcoholic Fatty Liver Disease conditions: Chronic Hepatitis b studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1500 type: ESTIMATED name: Peg-Interferon α measure: HBsAg clearance measure: HBsAg clearance at 96 weeks measure: Cumulative HBsAg clearance rate measure: Liver Function Tests measure: The incidence of liver cirrhosis and liver cancer sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Ningbo No.2 Hospital status: RECRUITING city: Ningbo country: China name: Hongshan Li role: CONTACT phone: 13738865021 lat: 29.87819 lon: 121.54945 facility: Ruian People's Hospital status: RECRUITING city: Rui'an country: China name: Liang Hong role: CONTACT phone: 13958805550 facility: The Second Affiliated Hospital of Wenzhou Medical University status: RECRUITING city: Wenzhou country: China name: Chenwei Pan role: CONTACT phone: 13587655994 lat: 27.99942 lon: 120.66682 facility: Wenzhou People's Hospital status: RECRUITING city: Wenzhou country: China name: Ran Ding role: CONTACT phone: 18057788513 lat: 27.99942 lon: 120.66682 facility: Yueqing People's Hospital status: RECRUITING city: Yueqing country: China name: Hui Zhao role: CONTACT phone: 13968713322 hasResults: False
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<|newrecord|> nctId: NCT06368869 id: #1/2022 briefTitle: The Effect of Different Types of Resin Cements on the Color Stability of Two Different Types of Ceramic Veneers overallStatus: COMPLETED date: 2023-01-10 date: 2024-01-20 date: 2024-01-20 date: 2024-04-16 date: 2024-04-16 name: amr elshimy class: OTHER briefSummary: Aim of the study was to evaluate the color stability of lithium disilicate ceramic veneers and zirconia reinforced lithium silicate ceramic veneers by using two different types of resin cements including light cured and dual cured cements. conditions: Color; Change Teeth, Posteruptive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 44 type: ACTUAL name: Livento press veneers luted with dual cured resin cement name: Livento press veneers luted with light cured resin cement name: Celtra duo veneers luted with dual cured resin cement name: Celtra duo veneers luted with light cured resin cement measure: Color stability assessment sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Faculty of Dentistry, Alexandria University city: Alexandria country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False
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<|newrecord|> nctId: NCT06368856 id: 20CH024 id: 2020-006105-30 type: EUDRACT_NUMBER briefTitle: Pharmacology of Mupirocin in Nasal Application in Healthy Volunteers: Monocentric Study acronym: MUPIPHARM overallStatus: RECRUITING date: 2024-02-29 date: 2024-11 date: 2025-03 date: 2024-04-16 date: 2024-04-16 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: Mupirocin is an old antibiotic used topically since the 1970s. Initially used in the treatment of skin infections for its antistaphylococcal action, it is now part of the decolonization strategy for Staphylococcus aureus (SA) carriage, in association with chlorhexidine. This decolonization strategy has been recommended in France for preoperative cardiac surgery in nasal SA carriers since 2013 by the French Hospital Hygiene Society, and recommended for cardiac and orthopedic surgery in SA carriers by the World Health Organization (WHO) since 2016. This strategy includes nasal decolonization using mupirocin ointment nasally (2 to 3 applications/day), a daily shower with chlorhexidine soap and + /- mouthwashes all over 5 days, often pre-operatively.
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As a result, mupirocin is now widely used throughout the world, all the more so as, for reasons of ease of organization, many centers use this decolonization procedure universally (i.e. without prior screening for Staphylococcus aureus carriage), thus further increasing the use of this molecule.
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Mupirocin administration methods are very vague, ranging from 2 to 3 applications per day and the application of "a match head", i.e. 50 mg, to 500 mg per nostril.
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Mupirocin is bacteriostatic at low doses, becoming bactericidal at higher concentrations; low concentrations could favor the selection of resistance, so using the most effective dosage seems essential. This lack of precision in administration is linked to an almost complete ignorance of the pharmacokinetics of mupirocin and its metabolite (monic acid) after nasal application.
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It therefore seems essential to conduct a pharmacokinetic study of this molecule, in order to eventually offer patients the regimen with the administration methods offering the best characteristics in terms of dosage and efficacy. conditions: Healthy conditions: Staphylococcus Aureus Infection studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Single-center, randomized, open-label pharmacokinetic study of mupirocin in 40 healthy subjects with 2 randomization :
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* first randomization - single dose part : 50mg or 500mg of mupirocin
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* wash-out: one month
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* second randomization - repeated doses part: 50mg mupirocin twice a day or 50 mg 3 times a day 500mg mupirocin twice a day or 500mg mupirocin 3 times a day primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: Mupirocin (50 mg) name: Mupirocin (500 mg) name: blood samples after Single dose part name: nasal swab after Single dose part name: Collection of urine after Single dose part name: nasal swab during Repeated dose part name: Collection of urine during Repeated dose part name: nasal swab after Repeated dose part measure: plasma concentrations of mupirocin measure: plasma concentrations of mupirocin measure: plasma concentrations of mupirocin measure: intranasal concentrations of mupirocin measure: intranasal concentrations of mupirocin measure: intranasal concentrations of mupirocin measure: intranasal concentrations of mupirocin measure: intranasal concentrations of mupirocin measure: intranasal concentrations of mupirocin measure: presence of Staphylococcus aureus measure: presence of Staphylococcus aureus measure: presence of Staphylococcus aureus measure: presence of Staphylococcus aureus measure: urinary concentrations of monic acid measure: urinary concentrations of monic acid measure: urinary concentrations of monic acid measure: urinary concentrations of monic acid sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de SAINT-ETIENNE status: RECRUITING city: Saint-Étienne country: France name: Kasra AZARNOUSH, MD PhD role: PRINCIPAL_INVESTIGATOR name: Elisabeth BOTELHO-NEVERS, MD PhD role: SUB_INVESTIGATOR name: Anne CARRICAJO, MD role: SUB_INVESTIGATOR name: Philippe BERTHELOT, MD PhD role: SUB_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False
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<|newrecord|> nctId: NCT06368843 id: Ketamine for POST briefTitle: the Impact of Ketamine Gargling on the Incidence of Post Intubation Sore Throat overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-08-15 date: 2024-09-20 date: 2024-04-16 date: 2024-04-16 name: Al-Azhar University class: OTHER briefSummary: Tracheal intubation often causes trauma to the airway mucosa, leading to postoperative sore throat (POST), which has been reported to occur in 21-65% of cases. While considered a minor complication, POST can contribute to postoperative discomfort and patient dissatisfaction. conditions: Postoperative Sore Throat studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Gargle with ketamine measure: Sore throat measure: Cough measure: Hoarseness of voice sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Ministry of Health city: Baghdad state: Thi-Qar zip: 00964 country: Iraq lat: 33.34058 lon: 44.40088 hasResults: False
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<|newrecord|> nctId: NCT06368830 id: 2024-0337 id: A534100 type: OTHER domain: UW Madison id: Protocol Version 3/4/24 type: OTHER domain: UW Madison briefTitle: Oral and Swallowing Function in Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-05 date: 2024-04-16 date: 2024-04-16 name: University of Wisconsin, Madison class: OTHER briefSummary: The purpose of this study is to learn about oral and swallowing function in older adults presenting to the emergency department. The hypothesis is that older adults often have problems with oral and swallowing function and these problems relate to other conditions. Study activities are done during the emergency department visit and include providing saliva samples, completing a bedside water swallow test, completing oral function assessments, completing respiratory function tests, and answering survey questions. conditions: Oropharyngeal Dysphagia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: 3-ounce water swallow test name: Kayser-Jones Brief Oral Health Status Examination (BOHSE) name: Tongue pressure name: Test of Masticating and Swallowing Solids (TOMASS) name: Respiratory function tests measure: Positive oropharyngeal dysphagia screen prevalence measure: Mean brief oral health status examination (BOHSE) score measure: Oral dryness prevalence measure: Decreased tongue pressure prevalence measure: Decreased masticatory function prevalence measure: pH of saliva sample measure: Extensional viscosity of saliva sample measure: Salivary Substance P Concentration measure: Oral microbiome measure: Cell barrier function measure: Protein composition measure: Gene expression measure: Immunofluorescent staining measure: Immune cell trafficking sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06368817 id: ACNS2321 briefTitle: Chemotherapy Followed by Response-Based Reduced Radiation Therapy for Patients With Central Nervous System Germinomas overallStatus: NOT_YET_RECRUITING date: 2024-05-04 date: 2033-11-04 date: 2033-11-04 date: 2024-04-16 date: 2024-04-16 name: Children's Oncology Group class: NETWORK briefSummary: A phase II trial that is attempting to build upon the excellent results of ACNS1123 stratum 2 by reducing the Radiotherapy (RT) dose for patients in a Complete Response (CR) after chemotherapy. The trial will be testing a further reduction in the whole ventricular irradiation (WVI) dose. Additionally, patients with metastatic disease and basal ganglia and thalamic germinoma will be included, and they will be treated with craniospinal irradiation (CSI) or whole brain irradiation (WBI) respectively. conditions: Intracranial Germ Cell Tumor conditions: Childhood Central Nervous System Germinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 240 type: ESTIMATED name: 3-Dimensional Conformal Radiation Therapy name: Carboplatin name: Etoposide name: Intensity-Modulated Radiation Therapy measure: Event-free survival (EFS) measure: Estimate the EFS distribution for eligible and evaluable patients in Stratum 2 measure: To estimate the EFS distribution for eligible and evaluable patients in Stratum 3 measure: Overall Survival (OS) measure: Determine the impact of tumor location, treatment regimen and treatment modalities on the long-term neuroendocrine function for patients with CNS germinomas. measure: Prospectively evaluate processing speed of children and young adults with CNS germinoma through the Children's Oncology Group (COG) Standardized assessment battery. measure: EFS distribution for eligible and evaluable patients in Stratum 4 and Stratum 5. measure: EFS distribution for eligible and evaluable patients in Stratum 6 and Stratum 7. measure: prospectively collect blood, cerebrospinal fluid, and tumor tissue at diagnosis and second-look surgery (if feasible) for future biology studies. measure: Incidence of cerebral vascular events (stroke or transient ischemic attacks) of children and young adults with CNS germinoma through the COG Standardized assessment battery: Patient-reported outcome measures measure: Incidence of cerebral vascular events (stroke or transient ischemic attacks) of children and young adults with CNS germinoma through the COG Standardized assessment battery: Health-reported quality of life sex: ALL minimumAge: 3 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06368804 id: ANTEIPA id: 2022-A01575-38 type: OTHER domain: ID-RCB briefTitle: Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis acronym: ANTEIPA overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-11-01 date: 2028-06-01 date: 2024-04-16 date: 2024-04-18 name: Centre Hospitalier Intercommunal Creteil class: OTHER name: Assistance Publique - Hôpitaux de Paris briefSummary: Chronic airways infection with Pseudomonas aeruginosa (PA) is associated with increased frequency of exacerbations, deterioration in quality of life and increased mortality in adult patients with bronchiectasis. Current guidelines suggest the prescription of an eradication antibiotic treatment for a first episode of PA infection (early PA infection). Several antibiotic regimens may be proposed, ranging from a monotherapy with oral fluoroquinolone (FQ) to an intravenous cotherapy with the addition of inhaled antibiotics that seems to improve the rate of PA eradication. As no study strictly favoured one regimen, current practices are heterogeneous and could certainly benefit from stronger evidence, with both medical and economic impact. conditions: Bronchiectasis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 196 type: ESTIMATED name: Antibiotic monotherapy treatment and follow-up name: Antibiotic bitherapy treatment and follow-up measure: PA-eradication rate measure: Time to first exacerbation measure: 1 year-exacerbation rate measure: Quality-of-life using questionnaires measure: Quality-of-life using questionnaires measure: Treatment burden assessment using questionnaires measure: Quality-of-life using questionnaires measure: Detection of PA at 3-month and 1 year measure: Time to first PA-recurrence measure: Emergence of FQ-resistant strains of (PA or other bacteria) measure: Adverse event (AE) and serious AE at 12 months follow-up measure: Number of premature ending of one of the treatment in study due to any AE measure: Number of premature ending of one of the treatment in study measure: Proportion of non-administered doses of nebulized colistin measure: Cost and incremental cost effectiveness ratio at 1 year measure: Cost and incremental cost effectiveness ratio at 1 year measure: Cost and incremental cost effectiveness ratio at 1 year sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Amiens-Picardie city: Amiens country: France name: Damien BASILLE role: CONTACT lat: 49.9 lon: 2.3 facility: CHU Haut Leveque, Bordeaux city: Bordeaux country: France name: Julie MACEY role: CONTACT lat: 44.84044 lon: -0.5805 facility: CHRU Brest city: Brest country: France name: Francis COUTURAUD role: CONTACT lat: 48.3903 lon: -4.48628 facility: CH Pontoise city: Cergy-Pontoise country: France name: Bruno PHILIPPE role: CONTACT lat: 49.03894 lon: 2.07805 facility: Centre hospitalier intercommunal de Créteil city: Créteil zip: 94010 country: France name: Bernard MAITRE role: CONTACT lat: 48.78333 lon: 2.46667 facility: APHP, Henri Mondor city: Créteil country: France name: Fréderic SCHLEMMER role: CONTACT lat: 48.78333 lon: 2.46667 facility: Hôpital de la Croix Rousse, HCL, Lyon city: Lyon country: France name: Gilles DEVOUASSOUX role: CONTACT lat: 45.74848 lon: 4.84669 facility: CHU Nantes city: Nantes country: France name: François-Xavier BLANC role: CONTACT lat: 47.21725 lon: -1.55336 facility: CHU H. Pasteur, Nice city: Nice country: France name: Sylvie LEROY role: CONTACT lat: 43.70313 lon: 7.26608 facility: APHP, Cochin city: Paris country: France name: Clémence MARTIN role: CONTACT lat: 48.85341 lon: 2.3488 facility: APHP, Saint Louis city: Paris country: France name: Abdellatif TAZI role: CONTACT lat: 48.85341 lon: 2.3488 facility: APHP, Tenon city: Paris country: France name: Nathalie ROZENSTAJ role: CONTACT lat: 48.85341 lon: 2.3488 facility: Hôpital Foch, Suresnes city: Suresnes country: France name: Emilie CATHERINOT role: CONTACT lat: 48.87143 lon: 2.22929 facility: CHU H. Larrey, Toulouse city: Toulouse country: France name: Marlene MURIS-ESPIN role: CONTACT lat: 43.60426 lon: 1.44367 facility: CH Versailles city: Versailles country: France name: Charlotte COLIN role: CONTACT lat: 48.8 lon: 2.13333 facility: CH Villefranche s/Saône city: Villefranche-sur-Saône country: France name: Sonia BLANDIN role: CONTACT lat: 45.98333 lon: 4.71667 hasResults: False
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<|newrecord|> nctId: NCT06368791 id: 30001479 briefTitle: Anti-Stress Intervention Among Physicians Study acronym: ASIP overallStatus: RECRUITING date: 2024-04-15 date: 2024-06-30 date: 2024-10-30 date: 2024-04-16 date: 2024-04-26 name: Charite University, Berlin, Germany class: OTHER briefSummary: Medical practice often comes with high stress. Stress negatively affects our health and well-being and is linked to doctors making mistakes, some of which can be deadly.
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In this study, the effect of two quick stress-relief methods on daily stress levels is estimated. The two anti-stress exercises are designed to easily fit into daily routines:
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1. Box breathing (6 minutes) is known to reduce stress and lower the heart rate. It is used by the military and law enforcement, among others, to manage stress.
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2. Breathing and mindfulness exercise (10 minutes): This guided breathing and mindfulness intervention combines mindful breathing with simple body movements, developed to reduce the perceived level of stress.
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The effectiveness of these interventions is being examined in a series of N-of-1 trials. Each participant can choose between the interventions. After being randomly allocated to an individual sequence of one-week intervention and control phases, the study begins. Participants record their stress levels daily over the four-week study period. The intervention is only performed in the intervention phases. Upon completing the study, the stress levels during the intervention phases are compared to those in the control phases. Each participant will receive an individual analysis based on the collected data. In addition, the investigators will estimate the effects at the population level.
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Three months after the study, a survey will be sent to the participants to check if the benefits have persisted. conditions: Stress, Psychological conditions: Burnout, Psychological conditions: Subjective Stress conditions: Occupational Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 34 type: ESTIMATED name: Box Breathing name: Breathing and Mindfulness Exercise name: Everyday life control measure: Daily perceived stress measure: Daily expectation of perceived stress level on the following day measure: Level of agreement between expected and actually perceived level of stress measure: Compliance with the study protocol: number of participant reported outcomes measure: Compliance with the study protocol: number of performed anti-stress interventions measure: Successful study completion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité - Universitätsmedizin Berlin status: RECRUITING city: Berlin zip: 10117 country: Germany name: Valentin M Vetter, MD role: CONTACT phone: 0049 30 450 566 298 email: valentin.vetter@charite.de lat: 52.52437 lon: 13.41053 hasResults: False
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<|newrecord|> nctId: NCT06368778 id: 166591 briefTitle: Real-Time Biofeedback on Partial Weightbearing Training overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-13 date: 2025-04 date: 2025-04 date: 2024-04-16 date: 2024-04-26 name: University of Utah class: OTHER briefSummary: The purpose of this study is to investigate the effectiveness of a biofeedback device (Loadsol) in training healthy subjects to comply with partial weightbearing, and to compare its outcomes with the standard of care training. Partial weightbearing is an essential component of rehabilitation and recovery for many orthopedic patients, yet it remains challenging for individuals to accurately gauge their weightbearing restrictions without proper guidance and feedback.
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The primary objective of the study is to determine whether the use of the biofeedback device (Loadsol) can reduce the time it takes for healthy subjects to learn and comply with partial weightbearing, compared to traditional training methods. The Loadsol device provides real-time auditory feedback on the individual's weightbearing status, potentially enhancing the learning process and adherence to weightbearing restrictions.
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Secondary objectives of the study include:
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Assessing the compliance of subjects with weightbearing restrictions in both the biofeedback and standard of care training groups, and comparing the results to identify any significant differences in adherence to the prescribed weightbearing limitations.
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Evaluating subject satisfaction with the training methods, as measured through questionnaires and the use of Patient-Reported Outcomes Measurement Information System (PROMIS) tools. This evaluation will help determine if the biofeedback device (Loadsol) leads to higher levels of satisfaction among subjects compared to the standard of care training.
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By examining these objectives, this study aims to provide valuable insights into the potential benefits of using a biofeedback device in partial weightbearing training, and to establish whether its implementation can lead to improved outcomes in learning, compliance, and overall patient satisfaction. conditions: Physical Therapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 105 type: ESTIMATED name: Verbal Advice name: Bathroom Scale name: Loadsol Biofeedback measure: Average peak force (Newtons, (N)) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: University of Utah Orthopaedic Center city: Salt Lake City state: Utah zip: 84108 country: United States lat: 40.76078 lon: -111.89105 hasResults: False
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<|newrecord|> nctId: NCT06368765 id: BL72 briefTitle: Oral Rehydration Solution and Dehydration Recovery overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-11 date: 2024-11 date: 2024-04-16 date: 2024-04-16 name: Abbott Nutrition class: INDUSTRY briefSummary: This is a prospective, randomized, controlled, blinded, crossover, study to evaluate the effects of an oral hydration solution. conditions: Dehydration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Oral Rehydration Solution (ORS) name: Water measure: Plasma Volume measure: Body Mass measure: Hydration Status Urine measure: Blood Biomarker - Plasma Osmolality measure: Blood Biomarker - Plasma Electrolyte Concentration measure: Blood Biomarker - Plasma Glucose Concentration measure: Body Temperature measure: Body Composition measure: Reaction Time measure: Handgrip Strength measure: Urine Volume measure: Hydration Status Saliva measure: Heart Rate measure: Blood Pressure measure: Thirst Sensation Scale measure: Gagge Thermal Scale measure: Urine Color measure: Palatability measure: Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06368752 id: H-22063621 briefTitle: The Role of Endogenous GIP in Glycosis Metabolism During Fasting overallStatus: ENROLLING_BY_INVITATION date: 2023-05-04 date: 2023-12-12 date: 2025-12-31 date: 2024-04-16 date: 2024-04-16 name: Frederikke Koefoed-Hansen class: OTHER briefSummary: This research project aims to investigate the role of endogenous GIP during fasting. With the infusion of a GIP receptor antagonist (GIP\[3-30\]NH2), is it possible to selectively remove the effect of endogenous GIP, and thus describe its effects by comparing it with what happens during a saline infusion. conditions: Obesity studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The trial is a randomized, double-blind, crossover study. We give intravenous infusion of GIP\[3-30\]NH2, and thus describe the effects of GIP by comparing with what happens during a saline infusion (placebo). primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: The infusion is mixed by an external coordinator. Neither the investigator or the participants knows whether is the GIP\[3-30\]NH2 infusion or saline infusion that is being given. Which infusion that is given on each trial day is randomized for each participant. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 12 type: ESTIMATED name: GIP[3-30]NH2 name: Saline measure: Plasma glucagon concentrations measure: Plasma levels of C-peptide measure: Plasma levels of insulin measure: Resting metabolic rate measure: Activity in brown adipose tissue measure: Appetite measure: Blood pressure measure: Puls sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gentofte Hospital city: Hellerup zip: 2900 country: Denmark lat: 55.73204 lon: 12.57093 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-04-10 uploadDate: 2024-04-11T04:12 filename: Prot_SAP_000.pdf size: 120286 hasResults: False
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<|newrecord|> nctId: NCT06368739 id: STUDY00005622 briefTitle: Evaluation of Medicaid Food & Nutrition Support Program for Pregnant Women overallStatus: ACTIVE_NOT_RECRUITING date: 2022-10-17 date: 2024-05-01 date: 2024-08-01 date: 2024-04-16 date: 2024-04-16 name: University of Texas at Austin class: OTHER name: Driscoll Health Plan briefSummary: With funding from the Episcopal Health Foundation, the researchers will conduct a secondary data analysis to evaluate the impact of Driscoll Health Plan's Nurture program for pregnant members using claims data. conditions: Pregnancy Related conditions: Financial Gift conditions: Nutrition, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: From the eligible population, DHP randomly selected a subset of approximately 500 women during the pilot period, from which approximately 200 were in the program, the "exposed group." The women who were covered during the same period but were not selected were not exposed to the program and will compose the "comparison group." primaryPurpose: PREVENTION masking: NONE count: 224 type: ACTUAL name: Nurture program name: Regular benefits measure: Composite outcome 1: Adverse health events during pregnancy measure: Composite outcome 2: Adverse health events at birth and newborn-related measure: Emergency Department visits measure: Cost (outpatient) measure: Cost (inpatient) measure: Cost (pharmacy/medication) measure: Cost (total) measure: Delivery mode (vaginal, C-section) measure: Birthweight sex: FEMALE minimumAge: 30 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Driscoll Health Plan city: Corpus Christi state: Texas zip: 78415 country: United States lat: 27.80058 lon: -97.39638 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-24 uploadDate: 2024-02-12T16:26 filename: Prot_SAP_000.pdf size: 630078 hasResults: False
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<|newrecord|> nctId: NCT06368726 id: SFND04042024 briefTitle: Result of tDCS in ASD Children With Comorbidities Like PANDAS, Rare Genetic Diseases or Autoimmune Disorders acronym: tDCS&ASD overallStatus: ENROLLING_BY_INVITATION date: 2024-04-01 date: 2025-05-01 date: 2025-07-01 date: 2024-04-16 date: 2024-04-16 name: Spanish Foundation for Neurometrics Development class: OTHER name: Fundacion para la Salud Materno Infantil briefSummary: Results of the application of 100 sessions of tDCS for 12 months in children between 6 and 11 years old with autism spectrum disorder with rare diseases, genetic problems or PANDAS conditions: Attention conditions: Visual Perceptual Weakness conditions: Social Behavior conditions: Fluency Disorder conditions: EEG With Periodic Abnormalities studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups of childs: 90 childs receive tDCS treatment and 90 traditional treatments with Risperidone educational training, speech therapy and visual training. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Assessments regarding clinical recovery will be conducted by an assessor blind to treatment allocation. whoMasked: INVESTIGATOR count: 180 type: ESTIMATED name: tDCS or Transcranial Direct Current Stimulation name: Risperidone measure: FFT measure: Power Density Spectrum Changes or PSD measure: ERP MMN changes measure: ERP MMN Changes measure: Attention measure: Social Skills measure: Language measure: Visual Contact sex: ALL minimumAge: 6 Years maximumAge: 11 Years stdAges: CHILD facility: New Remedies Ltd city: Liverpool state: Merseyside zip: L1 0AH country: United Kingdom lat: 53.41058 lon: -2.97794 hasResults: False
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<|newrecord|> nctId: NCT06368713 id: PD-GIEX briefTitle: Exercise Improves Gastrointestinal Function in Peritoneal Dialysis Patients overallStatus: RECRUITING date: 2024-03-01 date: 2025-06-30 date: 2025-12-31 date: 2024-04-16 date: 2024-04-16 name: Sichuan Academy of Medical Sciences class: OTHER briefSummary: This study will investigate the impact of exercise on gastrointestinal function in peritoneal dialysis patients. conditions: Peritoneal Dialysis conditions: Exercise conditions: Gastrointestinal Function conditions: Quality of Life conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 132 type: ESTIMATED name: Exercise measure: Change in GIQLI measure: Change in GSRS measure: Change in PAC-SYM measure: Change in 6-MWT measure: Change in SGA measure: Change in measured Gastrointestinal Hormones sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital,School of Medicine, University of Electronic Science and Technology of China status: RECRUITING city: Chengdu state: Sichuan zip: 610000 country: China name: Jin Chen, Doctor role: CONTACT lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06368700 id: CL-00001 briefTitle: The Hyalex Early Feasibility Study (EFS) overallStatus: RECRUITING date: 2024-04-04 date: 2025-10 date: 2026-10 date: 2024-04-16 date: 2024-04-16 name: Hyalex Orthopaedics, Inc. class: INDUSTRY briefSummary: The Hyalex Early Feasibility Study is a prospective, multicenter, open-label, single-arm, 2-phase early feasibility study to evaluate the safety and technical performance of the HYALEX Knee Cartilage System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment, will be enrolled in the study and undergo implantation of the HYALEX Knee Implant. conditions: Cartilage Injury conditions: Cartilage Damage studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 20 type: ESTIMATED name: Hyalex Knee Cartilage System measure: Freedom from implant rejection and infection. measure: Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) at 12 months. sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital for Special Surgery status: RECRUITING city: New York state: New York zip: 10021 country: United States name: Ava Neijna role: CONTACT phone: 917-260-3677 email: SGResearch@hss.edu name: Morgan Rizy role: CONTACT name: Sabrina Strickland, M.D. role: PRINCIPAL_INVESTIGATOR name: Andreas Gomoll, M.D. role: SUB_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Oregon Health & Science University status: RECRUITING city: Portland state: Oregon zip: 97239 country: United States name: Jessica Ballin role: CONTACT phone: 503-418-9580 email: ballin@ohsu.edu name: Dennis Crawford, M.D. role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 hasResults: False
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<|newrecord|> nctId: NCT06368687 id: 2023-06112-01 briefTitle: TRANPAS - TReating Anorexia Nervosa Plus Autism Spectrum acronym: TRANPAS overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-12-31 date: 2026-12-31 date: 2024-04-16 date: 2024-04-16 name: Göteborg University class: OTHER briefSummary: In a pilot study, we will validate a so-called autism care location in an inpatient ward. The care location will be adapted for patients with anorexia nervosa (AN) and concurrent autism (AN+autism). In order to investigate the effect of a tailored care location for patients with AN + autism, the evaluation will include weight development and changes in nutritional intake, eating disorder and anxiety symptoms. The overall aim is to improve treatment for this specific AN subgroup, that otherwise has a worse prognosis regarding AN recovery. conditions: Anorexia Nervosa conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pilot study. Ten consecutive patients with anorexia nervosa (AN) plus autism will be admitted to the autism care location at an inpatient ward for eating disorders. The planned period of care for each patient is 12 weeks. The patient will be assessed (including weight, height, self-report questionnaires and interviews) before admission, at discharge and 6 months later. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Anorexia nervosa plus autism measure: BMI change between baseline and discharge 12 weeks later measure: Change of level of anxiety between baseline and discharge 12 weeks later measure: Change of Quality of life between baseline and discharge 12 weeks later sex: ALL minimumAge: 25 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06368674 id: 2023-00363 briefTitle: Bridging the Gap: Creating a Continuum of Care overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2026-12-31 date: 2027-02-01 date: 2024-04-16 date: 2024-04-22 name: Göteborg University class: OTHER name: Vastra Gotaland Region name: Narhalsan Reasearch and Development primary care Region Vastra Gotaland name: Sahlgrenska University Hospital, Sweden name: Forte briefSummary: Coordination and integration between care settings is essential for the quality of care of frail older patients. An active follow-up by a case manager (CM) after discharge form an acute geriatric hospital ward has the potential to bridge the gap between hospital, primary and municipality care for frail older people. This study evaluates the effects of an active follow-up by a CM in primary care after discharge from a geriatric ward, with the following research questions: Can an active follow-up by CM for frail older people discharged from an acute geriatric ward, compared to those not receiving active follow up, Maintain/increase independence in activities of daily living, self-rated health and life satisfaction? Increase satisfaction with health care? Reduce health care consumption/be cost-effective? How feasible is the intervention and the study design from the perspective of the caregivers and the older person? This is a clinical controlled study with a process evaluation. Inclusion criteria are 75 years or older, frail and admitted to a geriatric ward.
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This study is relevant since today's highly specialized acute care is poorly adapted to the comprehensive needs of frail older people, and exposes them to avoidable risks such as loss of functional capacities causing unnecessary care needs and decreased wellbeing. Active follow-up by a CM after discharge may be an important way to integrate the care for frail older people, after receiving in-hospital geriatric care. This can improve the quality of care for this vulnerable group, and direct the right health care actions towards those in most need.
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