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<\|newrecord\|> nctId: NCT06355076 id: CSZ03 briefTitle: New Urethral Reconstruction in Robot-assisted Laparoscopic Radical Resection overallStatus: RECRUITING date: 2023-02-05 date: 2026-06 date: 2026-06 date: 2024-04-09 date: 2024-04-09 name: Qilu Hospital of Shandong University class: OTHER briefSummary: The purpose of this clinical trial is to compare new reconstruction and anastomosis in robot-assisted radical laparoscopic resection It will also understand the possibility of exploring new reconstruction in completely solving patients' postoperative urinary incontinence The main questions it aims to answer are:
Is there a significant improvement in urinary control in patients with new reconstruction compared with patients with anastomosis? The researchers compared the new reconstruction with anastomosis in robot-assisted laparoscopic radical resection to see if the new reconstruction improved urinary incontinence after operation.
Participants will:
The intervention group adopted the new reconstruction proposed by our team; End-to-end anastomosis was performed in non-intervention group. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The experimental group received a new urethral reconstruction technique, which involves suturing the levator ani muscle with the lateral striated muscle of the urethra, the dorsal median ridge (MDR), and the Di's fascia together for continuous suturing before performing bladder urethral anastomosis. After the reconstruction is completed, the end to end anastomosis of the bladder urethra is performed primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Patients in the experimental or control group, as well as their family members, are unaware whoMasked: PARTICIPANT count: 94 type: ESTIMATED name: New urethral reconstruction measure: Recovery of urinary incontinence measure: complication measure: PSA measure: recurrence sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Qilu hospital status: RECRUITING city: Jinan state: Shandong zip: 276600 country: China name: shouzhen chen role: CONTACT phone: 18560089085 email: 201900412102@mail.sdu.edu.cn lat: 36.66833 lon: 116.99722 hasResults: False
<\|newrecord\|> nctId: NCT06355063 id: NP-PCF-037 briefTitle: CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-08-31 date: 2025-10-31 date: 2024-04-09 date: 2024-04-09 name: Pulse Biosciences, Inc. class: INDUSTRY briefSummary: This feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more extensive surgical ablation set in conjunction with concomitant cardiac surgical procedure. conditions: Atrial Fibrillation conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study is a prospective, multicenter, single arm, non-randomized, feasibility study. primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: CellFX® nsPFA™ Cardiac Surgery System measure: Rate of acute major adverse events (MAEs) measure: Number of Participants with acute electrical isolation of the bilateral pulmonary veins and left atrial free wall. measure: Proportion of Participants with one or more SAEs measure: Number of Participants with Long-Term Technical Success sex: ALL minimumAge: 22 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Academic Medical Center city: Amsterdam country: Netherlands lat: 52.37403 lon: 4.88969 facility: Maastricht University Medical Center city: Maastricht country: Netherlands lat: 50.84833 lon: 5.68889 facility: St. Antonius Hospital city: Nieuwegein country: Netherlands lat: 52.02917 lon: 5.08056 hasResults: False
<\|newrecord\|> nctId: NCT06355050 id: UKJ-ultraHART briefTitle: Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer acronym: ultraHART overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2026-09-30 date: 2031-09-30 date: 2024-04-09 date: 2024-04-09 name: Jena University Hospital class: OTHER name: University Hospital Schleswig-Holstein name: Klinikum Stuttgart briefSummary: In this prospective, multi-center cohort study, the tolerability and quality of life during ultrahypofractionated radiotherapy (RT) of early stage prostate cancer is surveyed at several institutions in Germany. Radiotherapy is delivered with by an online-adaptive RT device (Varian Ethos), which is able to correct daily variations in anatomy and to adjust the irradiation plan accordingly. A digital patient questionnaire is used to asses quality of life longitudinally. Quality of life (QoL) and toxicity profiles will be correlated with planning parameters and compared to retrospective cohorts of patients who underwent normofractionated RT or moderately hypofractionated RT, respectively. conditions: Prostate Cancer conditions: Adaptive Radiotherapy conditions: Quality of Life studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Toxicity (CTCAE v5.0) measure: Quality of Life (EPIC 26) measure: Planning parameters measure: Dose constraints measure: Conformity indices measure: Quality of adaptive planning measure: PSA-value measure: Overall survival measure: Recurrence free survival sex: MALE minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Radiotherapy and Radiation Oncology, Jena University Hospital city: Jena country: Germany name: Klaus Pietschmann, MD role: CONTACT email: klaus.pietschmann@med.uni-jena.de name: Georg Wurschi, MD role: PRINCIPAL_INVESTIGATOR lat: 50.92878 lon: 11.5899 hasResults: False
<\|newrecord\|> nctId: NCT06355037 id: B2024.1.30 briefTitle: Dasatinib Combined With Quercetin to Reverse Chemo Resistance in Triple Negative Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-12-31 date: 2025-01-31 date: 2024-04-09 date: 2024-04-09 name: Fudan University class: OTHER briefSummary: This is a Phase II, open-label, single-arm study evaluating the efficacy and safety of combined treatment of dasatinib, quercetin with chemotherapy in mTNBC (triple negative breast cancer) patients who progressed during previous chemotherapy. conditions: Triple-negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Quercetin name: Dasatinib name: Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Progression Free Survival (PFS) measure: Safety and treatment-related AEs measure: Biomarker analysis1 measure: Biomarker analysis2 sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06355024 id: A2024.1.30 briefTitle: Inosine Reverse Chemo Resistance in Triple Negative Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-12-31 date: 2025-01-31 date: 2024-04-09 date: 2024-04-09 name: Fudan University class: OTHER briefSummary: This is a Phase II, open-label, single-arm study evaluating the efficacy and safety of combined treatment of Inosine with chemotherapy in mTNBC (triple negative breast cancer) patients who progressed during previous chemotherapy. conditions: Triple-negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Inosine name: Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Progression Free Survival (PFS) measure: Biomarker analysis1 measure: Safety and treatment-related AEs sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06355011 id: 7016194 briefTitle: Total Elbow Replacement in England: Analysis of National Joint Registry and Hospital Episode Statistics Data overallStatus: COMPLETED date: 2024-03-01 date: 2024-04-02 date: 2024-04-02 date: 2024-04-09 date: 2024-04-09 name: University of Manchester class: OTHER name: The National Joint Registry name: The Royal College of Surgeons of England name: John Charnley Trust name: University of Bristol briefSummary: The goal of this observational registry study is to provide detailed descriptions of the patients who are receiving primary total elbow replacement surgery in England. The main questions it aims to answer are:
* Who are receiving primary total elbow replacement surgery?
* Where and by whom is the total elbow replacement surgery is being performed?
* What the current surgical practices for total elbow replacement?
Pseudonymous data from the National Joint Registry NJR of all patients with total elbow replacement will be used. conditions: Total Elbow Replacement studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3891 type: ACTUAL name: Total Elbow Replacement measure: The incidence of total elbow replacement (TER) in England measure: Serious adverse events or re-admissions measure: Duration of elective wait measure: Post-operative duration of stay measure: Surgeon volume measure: Hospital volume measure: Patient characteristics (Age) measure: Body mass index measure: Hand dominance measure: American Society of Anaesthesiologists (ASA) grade measure: Indication for total elbow replacement measure: Socioeconomic status measure: Ethnicity measure: Co-morbidities measure: Charlson Comorbidity Index measure: Implant classification measure: Fixation type measure: Implant type measure: If radial head replacement was used measure: Grade of primary surgeon measure: Funding measure: Elective admission type sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester Academic Health Science Centre city: Manchester zip: M13 9PT country: United Kingdom lat: 53.48095 lon: -2.23743 hasResults: False
<\|newrecord\|> nctId: NCT06354998 id: mRNA-1273-P401 briefTitle: A Study of an Investigational mRNA-1273.815 COVID-19 Vaccine in Previously Vaccinated Adults overallStatus: RECRUITING date: 2024-04-08 date: 2024-06-01 date: 2024-06-01 date: 2024-04-09 date: 2024-04-22 name: ModernaTX, Inc. class: INDUSTRY briefSummary: To evaluate immune responses of an Investigational mRNA-1273.815 vaccine against the Omicron subvariant strain (XBB.1.5) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). conditions: SARS-CoV-2 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Investigational mRNA-1273.815 name: Licensed Spikevax Vaccine measure: Geometric Mean of Neutralizing Antibodies (nAbs) Against SARS-CoV-2-specific Strain at Day 15 measure: Number of Participants with Serious Adverse Events (SAEs), Adverse Events (AEs) of Special Interest (AESIs), and AEs Leading to Withdrawal From the Study measure: Seroresponse Rate of nAb Against the SARS-CoV-2-specific Strain at Day 15 measure: Geometric Mean Ratio of nAb Against the SARS-CoV-2-specific Strain for Investigational mRNA-1273.815 Over the Licensed Spikevax Vaccine at Day 15 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Paratus Canberra status: RECRUITING city: Canberra state: Australian Capital Territory zip: 2617 country: Australia lat: -35.28346 lon: 149.12807 facility: Holdsworth House status: RECRUITING city: Darlinghurst state: New South Wales zip: 2010 country: Australia lat: -33.87939 lon: 151.21925 facility: Paratus Brisbane status: RECRUITING city: Brisbane state: Queensland zip: 2617 country: Australia lat: -27.46794 lon: 153.02809 facility: USC Morayfield status: NOT_YET_RECRUITING city: Morayfield state: Queensland zip: 4506 country: Australia lat: -27.10876 lon: 152.94907 facility: University of the Sunshine Coast, South Bank status: RECRUITING city: South Brisbane state: Queensland zip: 4101 country: Australia lat: -27.48034 lon: 153.02049 facility: Emeritus Melbourne status: RECRUITING city: Camberwell state: Victoria zip: 3124 country: Australia lat: -37.84205 lon: 145.0694 facility: AusTrials Sunshine Hospital status: RECRUITING city: Melbourne state: Victoria zip: 3021 country: Australia lat: -37.814 lon: 144.96332 hasResults: False
<\|newrecord\|> nctId: NCT06354985 id: 23-5996 id: MODEX2023 type: OTHER domain: Clinical Trial Protocol Number id: FRN:183960 type: OTHER_GRANT domain: CIHR id: CTO Project ID: 4701 type: OTHER domain: Clinical Trials Ontario briefTitle: Modafinil and Exercise for Post Stroke Fatigue acronym: MODEX overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2027-09 date: 2027-09 date: 2024-04-09 date: 2024-04-09 name: University Health Network, Toronto class: OTHER briefSummary: A stroke happens when blood flow to the brain is stopped and the brain gets damaged. At least half of people with a stroke have fatigue months and even years later. A lot of people report fatigue as one of the worst symptoms post stroke that can affect daily activities and the length and quality of life. Though all the reasons for fatigue after stroke and how to best treat it are not fully understood, the investigators think that fatigue results from the stroke changing the brain, reducing physical fitness, and decreasing muscle strength. A stroke can also affect sleep and mood, which can impact how people feel too. It is also not known why women experience more fatigue than men after a stroke.
Some studies have tested a drug called Modafinil for post stroke fatigue, while other studies have tested exercise for it. Yet, there is unclear evidence for either treatment, so this study has two main aims:
1. Test if Exercise Program One is better than Exercise Program Two
2. Test if Modafinil is better than a Sugar Pill
As another aim, the investigators will also look at if combining Modafinil with exercise has any benefits.
This study will take place at 6 Canadian research sites to give a good representation of people after a stroke. Each person will be tested on fatigue, mood, fitness, thinking skills, sleep, and usual activity levels.
Participants will be assigned at random (like flipping a coin) to 1 of 4 groups:
1. Sugar Pill plus Exercise Program One
2. Sugar Pill plus Exercise Program Two
3. Modafinil plus Exercise Program One
4. Modafinil plus Exercise Program Two
The treatment will last 8 weeks. The Modafinil or Sugar Pill will be taken once a day. The exercise will be delivered virtually by a trained therapist over computer to people at home 3 times a week. Change in fatigue, quality of life, and other outcomes will be measured over 6 months.
The investigators will assess the results to identify the best treatment for post stroke fatigue and hope to be able to find a treatment that will help reduce fatigue and improve quality of life after a stroke. conditions: Stroke conditions: Fatigue conditions: Modafinil conditions: Exercise studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: All members of the research team and the participants will be blinded to medication group allocation, but cannot be blinded to exercise group allocation. Evaluators and the study statistician will be blinded to the exercise group allocation. The study statistician and the rest of the Data Safety Monitoring Board will have access to the medication assignment if needed (e.g. adverse drug reaction). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 224 type: ESTIMATED name: Modafinil 200mg name: Placebo name: Exercise Program One name: Exercise Program Two measure: Severity of Fatigue Symptoms measure: Severity of Fatigue Symptoms measure: Impact on Quality of Life measure: Walking Recovery measure: Leg Strength and Coordination measure: 3-Day Physical Activity Assessment measure: Mood and Anxiety measure: Attention measure: Cognition measure: Health Resource Utilization measure: Quality Adjusted Life Years sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06354972 id: SASP Turin briefTitle: Impact of SASP in the GCF on the Outcomes of Periodontal Regeneration overallStatus: COMPLETED date: 2022-01-02 date: 2022-11-02 date: 2024-01-02 date: 2024-04-09 date: 2024-04-09 name: University of Turin, Italy class: OTHER briefSummary: Objectives: To test the impact of clinical inflammation and molecular expression profile (senescence-associated secretory phenotype; SASP) in the gingival crevicular fluid (GCF) on the outcomes of minimally-invasive periodontal regeneration in intra-bony defects.
Methods: Sites associated with intrabony defects ≥ 3 mm requiring periodontal regeneration through minimally-invasive surgical technique were included. Pre-operatively, GCF was sampled for inflammatory biomarker analysis related to SASP \[interleukin (IL)-1β, IL-6 and IL-12; matrix-metalloproteinases (MMP)-8 and -9\]. Correlation analyses and logistic regression models were performed to assess the impact of predictors on clinical and radiographic outcomes. conditions: Periodontal Diseases studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 40 type: ACTUAL name: Minimally invasive surgical procedure measure: Clinical attachment level change measure: Achievement of composite outcome measure measure: Radiographic bone level change measure: Probing pocket depth change sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CIR Dental School city: Turin zip: 10126 country: Italy lat: 45.07049 lon: 7.68682 hasResults: False
<\|newrecord\|> nctId: NCT06354959 id: 1030020 briefTitle: Prehab for Lung and Esophageal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-01 date: 2027-01-01 date: 2024-04-09 date: 2024-04-09 name: Nova Scotia Health Authority class: OTHER name: Dalhousie University briefSummary: Research indicates that individuals diagnosed with lung or esophageal cancer who enter treatment with higher functional capacities, improved body composition, and better nutrition status tend to experience better outcomes and a higher quality of life. The primary objective of a prehabilitation health coaching program is to enhance the overall health and well-being of patients before they undergo major surgery.This personalized 8-week program encompasses elements such as nutrition, smoking cessation, sleep hygiene, and movement, equipping participants with the knowledge and tools needed to adopt healthier lifestyles. conditions: Neoplasm of Lung conditions: Neoplasms conditions: Exercise conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 25 type: ESTIMATED name: Prehabilitation measure: Feasibility- Recruitment measure: Feasibility- Participant fidelity measure: Feasibility - Safety measure: Feasibility - Retention/Attrition measure: Feasibility - Participant Experience measure: Feasibility- Attendance measure: Functional Assessment of Cancer Therapy - Lung OR Esophageal (FACT-L/ FACT- E) measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) measure: 5x chair stand measure: Stair climb test measure: Grip strength measure: Resting Heart rate measure: Resting blood pressure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Victoria General Hospital city: Halifax state: Nova Scotia country: Canada name: Jodi Langley role: CONTACT email: jodi.langley@dal.ca lat: 44.64533 lon: -63.57239 hasResults: False
<\|newrecord\|> nctId: NCT06354946 id: SCORE 4C briefTitle: External Validation of Simplified 4C Mortality Score by Deleting CRP acronym: 4Cs overallStatus: COMPLETED date: 2020-01-01 date: 2022-11-30 date: 2022-12-30 date: 2024-04-09 date: 2024-04-09 name: University of Monastir class: OTHER briefSummary: The (Coronavirus Clinical Characterisation Consortoum) 4C mortality score is an accessible risk stratification score developed by the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC) based on eight different parameters: age, sex, number of comorbidities, respiratory rate, peripheral oxygen saturation, level of consciousness (Glasgow Coma Scale), urea or blood urea nitrogen (BUN) level, and C reactive protein (CRP). It was derived and internally validated on a large, diverse cohort within the United Kingdom but requires external validity to confirm its generalizability. A recent validation study demonstrated that the score could be simplified by deleting CRP item which is favorable to its widespread use. we aim to validate a modified 4C score. conditions: COVID-19 Pandemic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1500 type: ACTUAL measure: The primary outcome was all-cause in-hospital mortality rate The primary outcome was all-cause in-hospital mortality rate measure: Number of patients admitted to the ICU sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: EPS Fattouma Bourguiba University hospital city: Monastir zip: 5020 country: Tunisia lat: 35.77799 lon: 10.82617 hasResults: False
<\|newrecord\|> nctId: NCT06354933 id: DemeNSS (3785) briefTitle: Neurological Soft Signs in Neurodegenerative Dementias acronym: DemeNSS overallStatus: COMPLETED date: 2022-04-01 date: 2023-11-30 date: 2024-02-01 date: 2024-04-09 date: 2024-04-15 name: University of Milano Bicocca class: OTHER briefSummary: The goal of this observational study is to investigate the prevalence of Neurological Soft Signs (NSS) in various categories of dementia patients compared to matched controls. The main questions it aims to answer are:
* Does the prevalence of NSS significantly differ among patients with neurodegenerative dementias compared to controls?
* Are NSS associated with neuropsychiatric alterations in dementia patients?
* Do NSS correlate with cognitive screening tools?
* Do NSS increase over time in patients with neurodegenerative dementias?
Participants will undergo assessments including:
* Evaluation of NSS using the Heidelberg scale
* Neuropsychiatric assessments
* Cognitive screening using the Mini-Mental State Examination (MMSE) and Frontal Assessment Battery (FAB)
Researchers will compare dementia groups (Alzheimer's disease, Frontotemporal dementia, Corticobasal syndrome and Lewy body dementia) to controls to determine differences in NSS prevalence. Additionally, associations between NSS and neuropsychiatric symptoms, as well as cognitive performance, will be explored. conditions: Alzheimer Disease conditions: Dementia With Lewy Bodies conditions: Frontotemporal Dementia conditions: Corticobasal Degeneration studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 186 type: ACTUAL name: Neurological Soft Signs measure: Difference in NSS measure: Association between NSS and Neuropsychiatric Inventory (NPI) scores measure: Correlation between NSS scores and cognitive function assessed by Mini-Mental State Examination (MMSE) measure: Correlation between NSS scores and cognitive function assessed by Frontal Assessment Battery (FAB) measure: Longitudinal changes in NSS scores sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS San Gerardo dei Tintori city: Monza state: Lombardia zip: 20900 country: Italy lat: 45.58005 lon: 9.27246 hasResults: False
<\|newrecord\|> nctId: NCT06354920 id: HUM00247781 id: R18HS028963 type: AHRQ link: https://reporter.nih.gov/quickSearch/R18HS028963 briefTitle: M-Well Bonding Bundle to Improve Patient-Physician Relationships overallStatus: RECRUITING date: 2024-04-08 date: 2026-06 date: 2026-06 date: 2024-04-09 date: 2024-04-10 name: University of Michigan class: OTHER name: Agency for Healthcare Research and Quality (AHRQ) briefSummary: The goal of this clinical trial is to learn more about the interaction between a patient in the hospital and their treating doctor. A good relationship between patients and their doctors can help improve patient care. Doctors will be asked to use strategies to improve their interactions with patients in the hospital. The main questions it aims to answer are:
* Will using the intervention strategies improve doctors' empathy towards their patients?
* Will using the intervention strategies lead to improved scores in patient views of doctors' empathy?
There will be 2 study arms. One group of doctors will be asked to use the intervention strategies. The other group of doctors will provide care as they would normally.
Researchers will compare the doctors in the intervention arm to those in the control arm.
Doctors are the primary subjects for this study. The doctors in both study arms will be asked to do the following:
1. Allow study staff to observe the interaction between them and their patients.
2. Complete a brief survey at the end of their 2-week work rotation.
Doctors who are in the intervention arm will be asked to use suggested strategies when visiting with patients in the hospital.
Patients are secondary subjects for this study. Patients of participating doctors may be asked to do the following:
1. Allow study staff to observe the interaction between them and their doctors.
2. Complete a brief survey after meeting with their doctor. conditions: Physician-Patient Relations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Quasi-experimental randomized controlled trial primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 3624 type: ESTIMATED name: Bonding Bundle measure: Jefferson Scale of Empathy (JSE) measure: Jefferson Scale of Patient's Perceptions of Physician Empathy (JSPPPE) measure: Communication Assessment Tool measure: Frequency of use of intervention methods measure: Perceived duration of interaction measure: Wake Forest Physician Trust Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan status: RECRUITING city: Ann Arbor state: Michigan zip: 48109 country: United States name: Sanjay Saint, MD, MPH role: CONTACT phone: 734-615-8341 email: Saint@umich.edu name: Karen Fowler, MPH role: CONTACT phone: 734-845-3611 email: Karen.Fowler@va.gov name: Sanjay Saint, MD, MPH role: PRINCIPAL_INVESTIGATOR name: Christopher Smith, MD role: SUB_INVESTIGATOR lat: 42.27756 lon: -83.74088 facility: VA Ann Arbor Healthcare System status: NOT_YET_RECRUITING city: Ann Arbor state: Michigan zip: 48109 country: United States name: Nathan Houchens, MD role: CONTACT phone: 734-845-5922 email: nathanho@med.umich.edu name: Karen Fowler, MPH role: CONTACT phone: 734-845-3611 email: Karen.Fowler@va.gov name: Nathan Houchens, MD role: PRINCIPAL_INVESTIGATOR name: Sanjay Saint, MD, MPH role: SUB_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False
<\|newrecord\|> nctId: NCT06354907 id: HUM00150780 briefTitle: Improving Mental Health in School-age Children Through the Kids' Empowerment Program (KEP) acronym: KEP overallStatus: ACTIVE_NOT_RECRUITING date: 2022-10-03 date: 2024-10-02 date: 2024-10-02 date: 2024-04-09 date: 2024-04-12 name: University of Michigan class: OTHER briefSummary: Depression and anxiety are major challenges to American children's optimal mental health, with already high rates exacerbated by the Covid-19 pandemic. Yet help is beyond reach for many children who do not have access to care for reasons including a severely depleted cadre of professionally trained service providers, fear of stigma that goes along with a diagnosis, low access to clinics, and lack of insurance. Without help their problems will likely accelerate and become more deleterious to their development as adolescents and young adults. The current study aims to address the lack of care by providing a program in school classrooms that will reduce children's symptoms of depression and anxiety, as well as enhance their emotion regulation and coping skills. The mental health and adjustment of two groups of children are compared and evaluated at twelve week intervals in this clinical trial - those who first participate in the Kids' Empowerment Program (KEP) and a comparison group that participates in the program after the second evaluation. Once proven to be successful, the ultimate goal of the project is to disseminate the program throughout the State of Michigan and beyond, thereby providing children with tools that will empower them to be successful in managing emotional challenges throughout their life. conditions: Child Mental Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups of children and their parent will be compared and evaluated twice (twelve weeks apart). The first group (approximately half of the sample) will participate in the Kids' Empowerment Program in their classroom and their parent will complete assessments online. The second group will complete both assessments and then receive the program in their classroom after the 12 week interval. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: To minimize the possibility of a breach in confidentiality, each child's and parent's information is protected with a code number that will be associated with all of their study materials instead of their name. All identifying information is stored in a separate locked cabinet in the office of Dr. Graham-Bermann. All other study materials (without names) will be kept in a locked cabinet in the research laboratory of Dr. Graham-Bermann to maintain privacy. whoMasked: PARTICIPANT count: 120 type: ESTIMATED name: The Kids' Empowerment Program measure: Revised Children's Anxiety and Depression Scale measure: Strengths and Difficulties Questionnaire measure: Cognitive Emotion Regulation Questionnaire measure: EPOCH Questionnaire sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 hasResults: False
<\|newrecord\|> nctId: NCT06354894 id: MACOXS id: 133/2020/U type: REGISTRY domain: MACOXS briefTitle: Percutaneous Pinning Versus Plate and Screws for Surgical Fixation of Proximal Humeral Fractures overallStatus: RECRUITING date: 2020-11-01 date: 2024-11-01 date: 2024-11-01 date: 2024-04-09 date: 2024-04-09 name: University of Turin, Italy class: OTHER briefSummary: The aim of this multicenter nonrandomised study is to prospectively compare the clinical and radiographic results of two different techniques of surgical fixation of proximal humeral fractures: percutaneous pinning versus plate and screws. conditions: Proximal Humeral Fractures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Proximal humeral fracture fixation measure: Oxford Shoulder Score (OSS) measure: Quick Disabilities of the arm, shoulder and hand (DASH) score measure: Subjective Shoulder Value (SSV) measure: Radiographic outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: San Luigi Gonzaga Hospital status: RECRUITING city: Orbassano state: Turin zip: 10043 country: Italy name: Enrico Bellato, MD role: CONTACT phone: +393406429207 email: enrico.bellato@unito.it lat: 45.00547 lon: 7.53813 hasResults: False
<\|newrecord\|> nctId: NCT06354881 id: 0967 id: TM61008S3 type: OTHER_GRANT domain: British Heart Foundation briefTitle: The Relationship Between Controlling Risk Factors and Cerebral Haemodynamics in Lacunar Stroke acronym: LACUNAR_CA overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03 date: 2026-03 date: 2024-04-09 date: 2024-04-09 name: University of Leicester class: OTHER name: British Heart Foundation name: University Hospitals, Leicester briefSummary: The goal of this observational study is to look at differences in brain blood flow before and after management of risk factors such as high blood pressure and diabetes in patients with lacunar stroke. Participants will be asked to undergo a simple brain blood flow assessment at their initial appointment, whereby they will be asked to sit and stand twice. The patients will then be asked for a follow-up assessment 4 weeks after, identical to the first. This will allow us to look at any changes in brain blood flow from before management of risk factors and 4 weeks after management of risk factors. conditions: Lacunar Stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 75 type: ESTIMATED name: Transcranial Doppler Ultrasonography (TCD) during sit-stand manoeuvres measure: Cerebral blood velocity measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes. measure: Arterial blood pressure measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes. measure: Heart rate measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes. measure: End-tidal carbon dioxide measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes. measure: Compare cerebral haemodynamics in lacunar stroke patients with older patients experiencing advanced chronic cerebrovascular disease with lacunar stroke syndromes, whose risk-factors are already managed.(CA). measure: Compare cerebral haemodynamics in lacunar stroke patients with older patients experiencing advanced chronic cerebrovascular disease with lacunar stroke syndromes, whose risk-factors are already managed. (VMR). measure: Compare cerebral haemodynamics in lacunar stroke patients with older patients experiencing advanced chronic cerebrovascular disease with lacunar stroke syndromes, whose risk-factors are already managed.(ARI). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals of Leicester NHS Trust city: Leicester state: Leicestershire zip: LE1 5WW country: United Kingdom name: Amit Mistri role: CONTACT email: amit.mistri@uhl-tr.nhs.uk lat: 52.6386 lon: -1.13169 hasResults: False
<\|newrecord\|> nctId: NCT06354868 id: NNBioEP004 briefTitle: A Study to Assess utiLity of BIoEP as an Early Prognostic Indicator for Predicting Anti-Seizure Medication (ASM) Efficacy acronym: ECLIPSE overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-12 date: 2027-06 date: 2024-04-09 date: 2024-04-12 name: Neuronostics Ltd class: INDUSTRY name: Cornwall Partnership NHS Foundation Trust briefSummary: This multisite prospective clinical study is to investigate the relationship between seizure type and frequency with the BioEP result during ASM titration in newly diagnosed patients with epilepsy, and to assess the utility of BioEP as an early prognostic indicator of ASM efficacy conditions: Epilepsy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 158 type: ESTIMATED measure: The relationship between BioEP and seizure frequency. measure: Association between the 12-month change from baseline in BioEP result and the patients reported global impression of change sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06354855 id: NEU-FTR-FE-04 briefTitle: "Which Type of Exercise is More Effective in Chronic Constipation? overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-15 date: 2024-10 date: 2024-12 date: 2024-04-09 date: 2024-04-09 name: Necmettin Erbakan University class: OTHER briefSummary: In this study, it will be investigated whether a daily 30-minute walk or abdominal breathing exercise is more effective on chronic constipation. conditions: Chronic Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups with a conventional therapy control group primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The assignment of people to groups will be done by a statistician, apart from the research using a computer program. Randomization will be determined by entering the total number of cases through the program whose URL address is https://www.randomizer.org. whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Group is doing breathing exercises while watching videos name: Medium pace walking group measure: Visual Analog Scale (VAS) measure: Constipation Severity Scale (CSS) measure: Chronic Constipation Quality of Life Scale sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Nezahat Keleşoğlu Health Sciences Necmettin Erbakan University city: Konya state: Meram zip: 42000 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
<\|newrecord\|> nctId: NCT06354842 id: 12345678 briefTitle: Measurement of Sweat Sodium Concentration in Patients With Chronic Kidney Disease overallStatus: COMPLETED date: 2018-10-05 date: 2020-12-11 date: 2020-12-11 date: 2024-04-09 date: 2024-04-09 name: Medical University of Vienna class: OTHER briefSummary: It has been shown that excretion of sodium and water through the skin in the form of sweat represents a regulatory mechanism of electrolyte- and fluid balance. Since patients with chronic kidney disease (CKD) exhibit increased skin sodium content, we investigated the feasibility of sweat testing as a novel experimental tool to a more complete assessment of fluid- and sodium homeostasis.
In this cross-sectional feasibility study, we applied pilocarpine iontophoresis to induce sweat testing in 58 patients across various stages of CKD including patients after kidney transplantation as well as a healthy control cohort (n=6) to investigate possible effects of CKD and transplantation status on sweat rate and sodium concentration. Due to non-linear relationships, we modeled our data using polynomial regression.
Decline of kidney function showed a significant association with lower sweat rates: adj R²= 0.2278, F(2, 61) = 10.29, p = 0.000141. Sweat sodium concentrations were increased in moderate CKD, however this effect was lost in end stage renal disease: adj R² = 0.3701, F(4, 59) = 10.26, p = 2.261e-06. We observed higher sweat weight in males compared to females.
Diagnostic sweat analysis represents an innovative and promising noninvasive option for more thorough investigation of sodium- and fluid homeostasis in CKD patients. Lower sweat rates and higher sweat sodium concentrations represent a unique feature of CKD patients with potential therapeutic implications. conditions: Chronic Kidney Diseases studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 64 type: ACTUAL name: pilocarpine iontopheresis measure: Sweat sodium concentration sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Vienna city: Vienna zip: 1090 country: Austria lat: 48.20849 lon: 16.37208 hasResults: False
<\|newrecord\|> nctId: NCT06354829 id: MEDICALBUM briefTitle: Medical Images Collection Research acronym: MEDICALBUM overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2049-04 date: 2049-04 date: 2024-04-09 date: 2024-04-09 name: Mario Negri Institute for Pharmacological Research class: OTHER name: Papa Giovanni XXIII Hospital briefSummary: This is a not-for-profit project for the collection, archiving and reuse of magnetic resonance imaging, computed tomography and ultrasound images, and related demographic and clinical data, for research purposes only. conditions: Kidney Diseases conditions: Brain Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Medical imaging procedures measure: Creation of a medical images collection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Center for Rare Disease Aldo e Cele Daccò city: Ranica state: BG zip: 24020 country: Italy name: Anna Caroli, PhD role: CONTACT phone: +3903545351 email: anna.caroli@marionegri.it lat: 45.72328 lon: 9.71335 hasResults: False
<\|newrecord\|> nctId: NCT06354816 id: V 2.0, 07Feb2024 briefTitle: VENLID: The Application of a 10%-Lidocaine Spray Prior to the Insertion of a Peripheral Intra-venous Catheter in Female Adults acronym: VENLID overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-05 date: 2024-05 date: 2024-04-09 date: 2024-04-09 name: Krankenhaus Barmherzige Schwestern Linz class: OTHER briefSummary: Volunteers are invited to undergo 4 insertions of a peripheral intra-venous 18-gauge catheter (PIVC); 2 insertions at the the start of the study on the plantar side of the hand/vessel at the dorsum manus, 2 insertions after 2-10 hours into the forearm/cubita with and without application of a 10-% lidocaine spray (5 hubs of xylocaine 10%-pump spray; AstraZeneca BV, Zoetermeer, The Netherlands) prior to the insertion of the PIVC. conditions: Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: prospective, randomized, double-blind, controlled trial primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Xylocaine 10% pump spray name: Saline solution isotonic 0.9% NaCl measure: To demonstrate a reduction of pain caused by PIVC rated by Numerical Rating Scale (NRS), after application of a 10% lidocaine spray- Separately measured for the plantar side of the hand/vessel at the dorsum manus, and for the forearm/cubita measure: To measure pain caused by PIVC rated by NRS in the dominant vs. non-dominant arm measure: To measure pain caused by PIVC rated by NRS at the plantar side of the hand/vessel at the dorsum manus vs. at the forearm/cubita measure: To measure the correlation between pain caused by PIVC rated by NRS and the anticipated pain rated by NRS measure: To measure the correlation between pain caused by PIVC rated by NRS and the anticipated difficulty by the operator to insert the PIVC measure: To measure pain rated by NRS depending on success measure: To describe success rates and compare it measure: To measure the correlation between PCS and pain caused by PIVC rated by NRS sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06354803 id: KafrelsheikhU 30 briefTitle: Effect of Pezzi Ball on Balance in Pregnant Women overallStatus: COMPLETED date: 2023-03-02 date: 2024-02-02 date: 2024-03-03 date: 2024-04-09 date: 2024-04-09 name: Kafrelsheikh University class: OTHER briefSummary: The effect of kinaesthetic training on performance and postural stability during pregnancy and 2 weeks postpartum conditions: Postural Stability studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 45 participants with gestational age below 28 weeks primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE maskingDescription: The drawing procedure was conducted by a researcher without disclosure to the participants, ensuring unbiased allocation. Moreover, both the assessor and statistician remained blinded throughout the assessment period, unaware of the group assignments. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ACTUAL name: proprioceptive training measure: change of postural stability sex: FEMALE minimumAge: 25 Years maximumAge: 30 Years stdAges: ADULT facility: Faculty of physical therapy kafrelshiekh university city: Kafr Ash Shaykh state: Kafrelshiekh zip: 6850001 country: Egypt lat: 31.11174 lon: 30.93991 hasResults: False
<\|newrecord\|> nctId: NCT06354790 id: NatHis LAMA2 briefTitle: Natural History Study of Children With LAMA2-related Dystrophies acronym: LAMA2 overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2027-06-14 date: 2027-12-31 date: 2024-04-09 date: 2024-04-09 name: Institut de Myologie, France class: OTHER name: Association Française contre les Myopathies (AFM), Paris briefSummary: The goal of this natural history study is to characterize the disease course, characteristics in paediatric population of LAMA2-RD (related dystrophies) patients.
The aim of the study is to establish a well-described cohort of patients in France with LAMA2-RD for prospective follow-up and recruitment for future clinical trials.
Participants will be follow up during a two years period regarding exhaustive aspects of the pathology:
* Muscular function
* Respiratory function
* Cognitive phenotyping
* Quality of life
* Growth parameters
* Biomarkers conditions: Merosin Deficient Congenital Muscular Dystrophy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Motor evaluations name: Cognitive assessment name: Pulmonary function test name: Cardiac evaluation name: Quality of life name: Spine X Ray name: Muscular MRI name: Biomarkers collection and analysis measure: Change in Motor function Measurement (MFM32) score measure: Change in Motor Milestone Checklist measure: Change in Revised Upper Limb Module (RULM) score measure: Change in grip strength measured by dynamometer tool measure: Change in pinch strength measured by dynamometer tool measure: Change in arm flexion/extension strength measured by dynamometer tool measure: Change in 6 Minutes Walking Test measure: Change in 4 Stairs Climbing Test (4SCT) measure: Change in 10m Walking Test measure: Change in Rise from Floor Test measure: Change in patient's Forced Vital Capacity (FVC) results measure: Change in patient's Peak Cough Flow (PCF) results measure: Change in patient's Maximum Expiratory Pressure (MEP) results measure: Change in patient's Maximal Inspiratory Pressure (MIP) results measure: Change in patient's Sniff Nasal Inspiratory Pressure (SNIP) results measure: Change in patient's muscle fat replacement measured by Magnetic Nuclear Resonance measure: Change in patient's cross-sectional area of the residual muscle measured by MNR measure: Change in Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV) results measure: Change in Wechsler Intelligence Scale for Children-V (WISC-V) results measure: Change in PedsQL questionnaire results measure: Change in CGI-S questionnaire results measure: Change in CGI-I questionnaire results measure: Change in Faces pain rating scale results measure: Change in Fatigue Severity Scale results measure: Change in ACTIVLIM questionnaire results measure: Change in Egen Klassifikation Scale Version 2 (EK2) results measure: Change in Caregiver burden questionnaire (LMDIS) results sex: ALL minimumAge: 2 Years maximumAge: 15 Years stdAges: CHILD facility: Centre de Référence GNMH, Pédiatrie Hôpital Raymond-Poincaré city: Garches country: France name: Isabelle BOSSARD role: CONTACT name: Marta GOMEZ, MD role: PRINCIPAL_INVESTIGATOR lat: 48.84226 lon: 2.18232 facility: Service de MPR pédiatrique L'Escale - HCL city: Lyon country: France name: Manel SAIDI role: CONTACT name: Carole VUILLEROT, MD role: PRINCIPAL_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Département de neuropédiatrie Pôle Femme Mère Enfant CHU de Montpellier - Hôpital Gui de Chauliac city: Montpellier country: France name: Léa THEVENET role: CONTACT name: Ulrike WALTHER-LOUVIER, MD role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 facility: Plateforme d'essais cliniques pédiatriques iMotion city: Paris country: France name: Dominique DUCHENE role: CONTACT name: Andreea SEFERIAN, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 hasResults: False
<\|newrecord\|> nctId: NCT06354777 id: EVERCOOL AF briefTitle: REView of ProcEdural FactoRs and Outcomes After Atrial Fibrillation Ablation With Active Esophageal COOLing: A Sub-Study of the REAL AF Registry acronym: EVERCOOL AF overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-11-30 date: 2024-12-30 date: 2024-04-09 date: 2024-04-09 name: Heart Rhythm Clinical and Research Solutions, LLC class: OTHER name: Attune Medical briefSummary: This is a multi-center sub-study examining the effectiveness of active esophageal cooling on subjects undergoing left atrial ablation for symptomatic Paroxysmal Atrial Fibrillation or Persistent Atrial Fibrillation. conditions: Atrial Fibrillation studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 312 type: ESTIMATED name: Ablation Procedure measure: To measure procedural efficacy after atrial fibrillation ablation in patients treated with active esophageal cooling. measure: To measure procedural efficacy after atrial fibrillation ablation in patients treated with active esophageal cooling. measure: To measure long term safety after atrial fibrillation in patients treated with active esophageal cooling. measure: Patient reported outcomes in patients treated with active esophageal cooling. measure: Physician reported outcome post procedure with active esophageal cooling. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06354764 id: 8780-UC1 briefTitle: Propensity to Hospitalize Patients From the ED in European Centers. acronym: eCREAM-UC1 overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-09 date: 2026-09 date: 2024-04-09 date: 2024-04-11 name: Mario Negri Institute for Pharmacological Research class: OTHER name: Astir S.r.l. name: Centre Hospitalier Universitaire Vaudois name: Orobix Life S.r.l. name: Fondazione Bruno Kessler briefSummary: The peer-to-peer comparison means center-to-center comparison, which requires adjusting for possible differences among centers to be fair and convincing. The first step to reach this goal is to develop a predictive model that accurately estimates each patient's probability of being admitted, starting from clinical conditions and boundary variables. Such a model would make it possible to calculate, for each ED, the expected hospitalization rate; that is, the hospitalization rate that would have been observed if the ED had behaved like the average of the EDs that provided the data to build the model itself. Comparing the observed hospitalization rate in the single ED with the expected rate derived from the model provides a rigorous method of comparing the department with the average performance, taking into account the characteristics of the patients treated and the conditions under which the ED operated. In other words, the predictive model represents the benchmark against which each ED is evaluated. conditions: Emergency Medicine studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 162000 type: ESTIMATED name: no intervention measure: Create two separate databases measure: Multivariable models measure: Adjusted comparison sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06354751 id: 327236 briefTitle: Maternity Care Experiences of Asylum-seeking and Refugee Women in Scotland acronym: MACAWS overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-04-20 date: 2025-07-01 date: 2024-04-09 date: 2024-04-09 name: University of Aberdeen class: OTHER briefSummary: The International Organisation of Migration reports that over half (52.4%) of international migrants in Europe are women. Evidence suggests that women with immigrant backgrounds often struggle to access healthcare across the world. Among migrant women, asylum-seeking and refugee women face higher risks of poor pregnancy and birth outcomes, including babies with low birth weight, physical and/or mental health problems or death related to pregnancy and/or childbirth. Previous studies have focused on immigrant women's experiences of care during pregnancy and birth and did not differentiate between asylum seekers, refugees, and economic migrants. This can make it difficult to compare studies accurately. This PhD study focuses on asylum-seeking and refugee women, using the definitions provided by the United Nations. Asylum-seeking women refer to women who seek protection in a country other than their own and are waiting for a decision on their status. Asylum seekers become refugees once their application has been processed and accepted.
A scoping review was conducted to understand the experiences of asylum-seeking and refugee women accessing maternity care in the UK, with a focus on Scotland. The review found that all studies that focused on the experiences of asylum-seeking and refugee women accessing maternity care were mainly based in England. The review identified the presence of specialist migrant services in maternity settings in Scotland and across the UK, but there was no information on their implementation or impact on women's outcomes. Additionally, there is limited evidence in the UK on the perceptions of healthcare professionals providing care to asylum-seeking and refugee women.
This PhD aims to close this gap in research by exploring this area more deeply in Scotland through mixed-methods studies of surveys with asylum-seeking and refugee women and interviews with maternity care leaders, policymakers, maternity healthcare professionals, and asylum-seeking and refugee women. conditions: Refugee conditions: Asylum-seeking Women conditions: Maternity studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 300 type: ESTIMATED measure: Exploring and understanding asylum-seeking and refugee women's experiences of maternity care in Scotland. measure: Evidence of healthcare professionals' experiences of providing maternity care for asylum-seeking and refugee women in Scotland. measure: Identification of the successful components of specialist migrant maternity services in Scotland. measure: Identification of gaps between care pathways and practice (implementation gap) and how this affects the quality of maternity care and women's experiences of maternity services measure: Information for policymakers on approaches needed to improve maternity care for refugee and asylum-seeking women at local and national levels. sex: FEMALE minimumAge: 16 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06354738 id: S66928 briefTitle: Improving Endometrial Cancer Assessment by Combining Genomic Profiling and Surgical Assessment acronym: EUGENIE overallStatus: RECRUITING date: 2023-01-16 date: 2028-11-01 date: 2028-11-01 date: 2024-04-09 date: 2024-04-17 name: University Hospital, Gasthuisberg class: OTHER name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS name: University Medical Centre Maribor briefSummary: EUGENIE is a prospective multicentre interventional study, focused on improving endometrial cancer (EC) assessment by combining the new technique of genomic profiling with surgical extra uterine disease assessment. The investigators aim to correlate EC stage to each of the molecular subgroups of disease and thereby guide surgical treatment and staging of EC by determining the association between molecular classification and disease stage and evaluating if and how disease stage in each of the molecular subgroups associates with prognosis. conditions: Endometrial Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1000 type: ESTIMATED name: total hysterectomy with bilateral salpingo-oophorectomy, lymph node staging and comprehensive peritoneal staging measure: Endometrial cancer stage measure: Molecular type of endometrial cancer measure: Overall survival measure: Time to recurrence sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Gasthuisberg, Katholieke Universiteit Leuven status: RECRUITING city: Leuven zip: 3000 country: Belgium name: Ayaka Wakatsuki role: CONTACT phone: +32 16 34 41 69 email: ayaka.wakatsuki@uzleuven.be name: Frédéric Amant, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 50.87959 lon: 4.70093 hasResults: False
<\|newrecord\|> nctId: NCT06354725 id: 2vs4 briefTitle: Effect of Weekly Plyometric Training Frequency on Youth Female Basketball Players: A Comparison of Two vs. Four Sessions overallStatus: COMPLETED date: 2023-11-01 date: 2024-01-20 date: 2024-02-20 date: 2024-04-09 date: 2024-04-09 name: Bruno Figueira class: OTHER name: Vytautas Magnus University briefSummary: Players were randomly assigned to a two-times-a-week (2PLYO, n = 15) or four-times-a-week (4PLYO, n = 15) PT (Plyometric Training) group. Both groups performed the same weekly total volume of jumps during PT in addition to regular basketball training and competition. The 2PLYO group performed 240 jumps over two sessions (120 jumps per session), and the 4PLYO group performed 240 jumps over four sessions (60 jumps per session). After the eight-week intervention, all players underwent a one-week detraining period with no PT training while basketball training and competitions continued. Testing was performed at baseline (pre-test), after intervention (post-test), and after the detraining period. Players were assessed for lower body power using jump tests (countermovement jump \[CMJ\], drop-jump \[DJ\] from a 20-cm box, and horizontal jump \[HJ\]; change of direction ability using a planned agility test; and speed using a 20-m sprint and a 5-m split. conditions: Physical Performance studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: INVESTIGATOR count: 30 type: ACTUAL name: Plyometric measure: Horizontal jump measure: CMJ measure: Drop Jump measure: Drop jump (RSI) measure: Linear sprint-5m measure: Linear sprint-20m measure: Change of direction sex: FEMALE minimumAge: 14 Years maximumAge: 16 Years stdAges: CHILD facility: Vytutas Magnus University city: Kaunas country: Lithuania lat: 54.90272 lon: 23.90961 hasResults: False
<\|newrecord\|> nctId: NCT06354712 id: 2024-45 briefTitle: Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients. overallStatus: RECRUITING date: 2024-04-04 date: 2025-03-01 date: 2025-03-01 date: 2024-04-09 date: 2024-04-09 name: Mansoura University class: OTHER briefSummary: A prospective, randomized, controlled, parallel clinical trial will be conducted at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to assess the efficacy of N-acetylcysteine in the prevention of radiotherapy induced oral mucositis in Head and Neck cancer patients. conditions: Oral Mucositis (Ulcerative) Due to Radiation studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: N-Acetyl-Cysteine with Institutional standard care name: Institutional standard care measure: Incidence of oral mucositis with grade ≥ 2 assessed weekly by World Health Organization scale for Oral Mucositis. measure: Time to develop oral mucositis with grade ≥ 2. measure: Duration of oral mucositis with grade ≥ 2. measure: Pain assessed by Visual Analog Scale (VAS). measure: Functional oral intake scale measure: Patient's quality of life assessed by Functional Assessment of Cancer Therapy in Head and Neck Cancer (FACT-H&N) version 4 sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Oncology and Nuclear Medicine of Mansoura University Hospital status: RECRUITING city: Mansoura country: Egypt name: Rasha Abd-Ellatif, Professor role: CONTACT lat: 31.03637 lon: 31.38069 hasResults: False
<\|newrecord\|> nctId: NCT06354699 id: RGS0000003993 briefTitle: A Longitudinal Study Looking at the Prevalence, Risk Factors & Consequences of Persistent Post-surgical Pain in Children acronym: POPSICLE overallStatus: RECRUITING date: 2023-06-26 date: 2028-06 date: 2028-07 date: 2024-04-09 date: 2024-04-09 name: Telethon Kids Institute class: OTHER briefSummary: The purpose of this study is to investigate the prevalence, risk factors and consequences of chronic post-surgical pain in children aged 0-16 years through a number of questionnaires completed at various timepoints, from before surgery up to 1 year post surgery. conditions: Chronic Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 5000 type: ESTIMATED measure: The prevalence of chronic post-surgical pain after 10- 12 months. measure: Identifying potential risk factors for chronic post-surgical pain sex: ALL maximumAge: 16 Years stdAges: CHILD facility: Telethon Kids Institute status: RECRUITING city: Perth state: Western Australia country: Australia name: Natalie P Jowett role: CONTACT phone: 08 6456 4809 email: Natalie.Jowett@telethonkids.org.au name: Lliana Slevin role: CONTACT phone: 08 64564806 email: Lliana.slevin@telethonkids.org.au name: Britta von Ungern-Sternberg, Professor role: PRINCIPAL_INVESTIGATOR name: David Sommerfield, Associate role: PRINCIPAL_INVESTIGATOR lat: -31.95224 lon: 115.8614 hasResults: False
<\|newrecord\|> nctId: NCT06354686 id: STUDY00004245 briefTitle: Characterizing the Scalp Tolerability of TMS overallStatus: RECRUITING date: 2024-02-12 date: 2026-05 date: 2027-05 date: 2024-04-09 date: 2024-04-09 name: Florida State University class: OTHER briefSummary: The primary objective is to characterize the tolerability of TMS by scalp location (over parietal, motor, modified Beam F3 prefrontal, THREE-D prefrontal, orbitofrontal, and medial prefrontal) and stimulation parameters (single pulse, 10 Hz, theta burst). The secondary objective is to evaluate the knee as a surrogate location to safely trial tolerability of novel TMS parameters. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: TMS Tolerability measure: Tolerability of TMS - Scalp Location measure: Tolerability of TMS - Stimulation parameters (single pulse, 10 Hz, theta burst). measure: Tolerability of TMS (Knee Location) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Florida State University status: RECRUITING city: Tallahassee state: Florida zip: 32306 country: United States name: Isabelle Taylor, MA role: CONTACT phone: 850-645-8882 email: imtaylor@fsu.edu lat: 30.43826 lon: -84.28073 hasResults: False
<\|newrecord\|> nctId: NCT06354673 id: 278/1-April-2024 briefTitle: Stellate Ganglion Block Combined With Dexmedetomidine or Subanesthetic Ketamine Infusion for Treatment of Neurostorm. overallStatus: ENROLLING_BY_INVITATION date: 2024-04-04 date: 2024-09-04 date: 2024-10-04 date: 2024-04-09 date: 2024-04-10 name: Zagazig University class: OTHER_GOV briefSummary: Neurostorming is a sudden and exaggerated stress response as a result of damage to the brain. With appropriate treatment and time, there is hope for individuals to overcome storming, regain consciousness, and work towards successfully recovering from brain injury. Most treatments for neurostorming involve the use of medications only such as dexmedetomidine, opioids, gabapentin and propofol to address secondary complications like high blood pressure and fever. These medications focus on slowing the body's stress response or relaxing the body. Stellate ganglion block (SGB) is a promising therapy for paroxysmal sympathetic hyperactivity (PSH), overcoming the limitations of systemic medications and may serve to recalibrate aberrant autonomic states. Ketamine is a potent dissociative agent which has sedative, analgesic and anesthetic properties beside its sympathomimetic effect. Its combination with stellate ganglion block is to oppose its sympathomimetic effect. Dexmedetomidine has analgesic and sedative effect which inhibits the sympathetic nerve activity through its action on the α2 receptor in the spinal cord. Hypothesis: Null hypothesis: There is no difference between the effects of stellate ganglion block combined with dexmedetomidine or subanesthetic ketamine infusion for treatment of neurostorm after traumatic brain injury in critically ill patients.Alternative hypothesis: There is a difference between the effects of stellate ganglion block combined with dexmedetomidine or subanesthetic ketamine infusion for treatment of neurostorm after traumatic brain injury in critically ill patients.which has sedative, analgesic and anesthetic properties beside its sympathomimetic effect. Aim of the work is achievement of effective treatment for the neurostorm after traumatic brain injury in critically ill patients with better outcomes and decrease intensive care unit (ICU) stay. conditions: Paroxysmal Sympathetic Hyperactivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 205 type: ESTIMATED name: Stellate ganglion block name: Dexmedetomidine name: Ketamine measure: To compare the time of remission of neurostorm symptoms measure: To assess effect of stellate ganglion block combined with either dexmedetomidine or subanesthetic ketamine infusion on changes in glascow coma scale score. measure: ▪ To measure the duration of intensive care unit (ICU) stay. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zagazig university city: Zagazig country: Egypt lat: 30.58768 lon: 31.502 hasResults: False
<\|newrecord\|> nctId: NCT06354660 id: 18804 id: J1I-MC-GZBY type: OTHER domain: Eli Lilly and Company briefTitle: Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-06 date: 2026-07 date: 2024-04-09 date: 2024-04-19 name: Eli Lilly and Company class: INDUSTRY briefSummary: The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and inadequate glycemic control. The study will last about 11 months and may include up to 11 visits. conditions: Diabetes Type 2 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 480 type: ESTIMATED name: Retatrutide name: Placebo measure: Change from Baseline in Hemoglobin A1c (HbA1c) (%) measure: Percentage of Participants Who Achieve HbA1c < 7.0% measure: Percentage of Participants Who Achieve HbA1c ≤ 6.5% measure: Percentage of Participants Who Achieve HbA1c < 5.7% measure: Change from Baseline in Fasting Serum Glucose measure: Percent Change from Baseline in Body Weight measure: Change from Baseline in Body Weight measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 5% measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 10% measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 15% measure: Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction measure: Percent Change from Baseline in Triglycerides measure: Percent Change from Baseline in Non- High-Density Lipoprotein (HDL) Cholesterol measure: Change from Baseline in Systolic Blood Pressure (SBP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Scottsdale Clinical Trials city: Scottsdale state: Arizona zip: 85260 country: United States name: Ernest Lee role: PRINCIPAL_INVESTIGATOR lat: 33.50921 lon: -111.89903 facility: Tucson Clinical Research Institute city: Tucson state: Arizona zip: 85712 country: United States name: Girish Karamchandani role: PRINCIPAL_INVESTIGATOR lat: 32.22174 lon: -110.92648 facility: San Fernando Valley Health Institute city: Canoga Park state: California zip: 91304 country: United States name: Jeffrey London role: PRINCIPAL_INVESTIGATOR lat: 34.20112 lon: -118.59814 facility: Ark Clinical Research city: Long Beach state: California zip: 90815 country: United States name: Martha Navarro role: PRINCIPAL_INVESTIGATOR lat: 33.76696 lon: -118.18923 facility: Northeast Research Institute (NERI) city: Fleming Island state: Florida zip: 32003 country: United States name: Senan Sultan role: PRINCIPAL_INVESTIGATOR lat: 30.0933 lon: -81.71898 facility: Ezy Medical Research city: Miami state: Florida zip: 33175 country: United States name: Manuel Fernandez role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: Clinical Research of Central Florida city: Winter Haven state: Florida zip: 33880 country: United States name: Eduardo Torres role: PRINCIPAL_INVESTIGATOR lat: 28.02224 lon: -81.73286 facility: Trinity Research Centers city: Marietta state: Georgia zip: 30064 country: United States name: Jean Philippe role: PRINCIPAL_INVESTIGATOR lat: 33.9526 lon: -84.54993 facility: Cotton O'Neil Clinical Research Center - Central Office city: Topeka state: Kansas zip: 66606 country: United States name: Michael Cox role: PRINCIPAL_INVESTIGATOR lat: 39.04833 lon: -95.67804 facility: NECCR PrimaCare Research city: Fall River state: Massachusetts zip: 02721 country: United States name: Ehab Sorial role: PRINCIPAL_INVESTIGATOR lat: 41.70149 lon: -71.15505 facility: Clinical Research Professionals city: Chesterfield state: Missouri zip: 63005 country: United States name: Timothy Jennings role: PRINCIPAL_INVESTIGATOR lat: 38.66311 lon: -90.57707 facility: Boeson Research MSO city: Missoula state: Montana zip: 59804 country: United States name: Aubrey Remmers role: PRINCIPAL_INVESTIGATOR lat: 46.87215 lon: -113.994 facility: NJ MedCare & NJ Heart city: Linden state: New Jersey zip: 07036 country: United States name: Preet Randhawa role: PRINCIPAL_INVESTIGATOR lat: 40.62205 lon: -74.24459 facility: Accellacare - Wilmington - 1917 Tradd Court city: Wilmington state: North Carolina zip: 28401 country: United States name: John Parker role: PRINCIPAL_INVESTIGATOR lat: 34.22573 lon: -77.94471 facility: Providence Health Partners-Center for Clinical Research city: Dayton state: Ohio zip: 45439 country: United States name: Joni Koren role: PRINCIPAL_INVESTIGATOR lat: 39.75895 lon: -84.19161 facility: Clinical Research of Philadelphia city: Philadelphia state: Pennsylvania zip: 19114 country: United States name: Donna Gavarone role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: Preferred Primary Care Physicians city: Uniontown state: Pennsylvania zip: 15401 country: United States name: Richard Cook II role: PRINCIPAL_INVESTIGATOR lat: 39.90008 lon: -79.71643 facility: Delricht Research - Tobias Gadson Boulevard - Charleston city: Charleston state: South Carolina zip: 29407 country: United States name: Edward Newton role: PRINCIPAL_INVESTIGATOR lat: 32.77657 lon: -79.93092 facility: Lifedoc Research - Lenox Park Drive city: Memphis state: Tennessee zip: 38115 country: United States name: Pedro Velasquez-Mieyer role: PRINCIPAL_INVESTIGATOR lat: 35.14953 lon: -90.04898 facility: Clinical Research Associates Inc city: Nashville state: Tennessee zip: 37203 country: United States name: Stephan Sharp role: PRINCIPAL_INVESTIGATOR lat: 36.16589 lon: -86.78444 facility: Dallas Diabetes Research Center city: Dallas state: Texas zip: 75230 country: United States name: Dan Lender role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: Prime Revival Research Institute city: Flower Mound state: Texas zip: 75028 country: United States name: WASIM HAQUE role: PRINCIPAL_INVESTIGATOR lat: 33.01457 lon: -97.09696 facility: Valley Institute of Research - Fort Worth city: Fort Worth state: Texas zip: 76164 country: United States name: alex guevara role: PRINCIPAL_INVESTIGATOR lat: 32.72541 lon: -97.32085 facility: Texas Valley Clinical Research city: Weslaco state: Texas zip: 78596 country: United States name: Eduardo Luna role: PRINCIPAL_INVESTIGATOR lat: 26.15952 lon: -97.99084 facility: Manassas Clinical Research Center city: Manassas state: Virginia zip: 20110 country: United States name: Nabil Andrawis role: PRINCIPAL_INVESTIGATOR lat: 38.75095 lon: -77.47527 facility: MultiCare Rockwood Cheney Clinic city: Cheney state: Washington zip: 99004 country: United States name: Jonathan Staben role: PRINCIPAL_INVESTIGATOR lat: 47.48739 lon: -117.57576 facility: Eastside Research Associates city: Redmond state: Washington zip: 98052 country: United States name: Chad Crystal role: PRINCIPAL_INVESTIGATOR lat: 47.67399 lon: -122.12151 facility: All India Institute of Medical Sciences city: Raipur state: Chhattisgarh zip: 492099 country: India name: Amritava Ghosh role: PRINCIPAL_INVESTIGATOR lat: 21.23333 lon: 81.63333 facility: Gujarat Endocrin Pvt Ltd city: Ahmedabad state: Gujarat zip: 380052 country: India name: parag Shah role: PRINCIPAL_INVESTIGATOR lat: 23.02579 lon: 72.58727 facility: Nirmal Hospital city: Surat state: Gujarat zip: 395002 country: India name: Piyush Desai role: PRINCIPAL_INVESTIGATOR lat: 21.19594 lon: 72.83023 facility: Victoria Hospital, Bangalore Medical College And Research Institute city: Bangalore state: Karnataka zip: 560002 country: India name: Sivaranjani Holigi role: PRINCIPAL_INVESTIGATOR lat: 12.97194 lon: 77.59369 facility: Government Medical College - Kozhikode city: Kozhikode state: Kerala zip: 673008 country: India name: Chandni R role: PRINCIPAL_INVESTIGATOR lat: 11.24802 lon: 75.7804 facility: S C B Medical College and Hospital city: Cuttack state: Odisha zip: 753001 country: India name: Jayanta Panda role: PRINCIPAL_INVESTIGATOR lat: 20.46497 lon: 85.87927 facility: Eternal Heart Care Center and Research Institute city: Jaipur state: Rajasthan zip: 302020 country: India name: Jugal Gupta role: PRINCIPAL_INVESTIGATOR lat: 26.91962 lon: 75.78781 facility: Brij Medical Centre Private Limited city: Kanpur state: Uttar Pradesh zip: 208020 country: India name: brij mohan role: PRINCIPAL_INVESTIGATOR lat: 26.46523 lon: 80.34975 facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran city: Mexico City state: Distrito Federal zip: 14080 country: Mexico name: Emma Chávez Manzanera role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 facility: Grupo Ollin Care city: Pachuca state: Hidalgo zip: 42000 country: Mexico name: Eduardo Zambrano Ruiz role: PRINCIPAL_INVESTIGATOR lat: 20.11697 lon: -98.73329 facility: Instituto Jalisciense de Investigacion en Diabetes y Obesidad city: Guadalajara state: Jalisco zip: 04460 country: Mexico name: Guillermo Gonzalez Galvez role: PRINCIPAL_INVESTIGATOR lat: 20.66682 lon: -103.39182 facility: Unidad biomedica avanzada monterrey city: Monterrey state: Nuevo León zip: 64460 country: Mexico name: Raymundo Garcia Reza role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Clínica García Flores SC city: Monterrey state: Nuevo León zip: 64610 country: Mexico name: Pedro Garcia role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Centro de investigación y control metabólico city: Monterrey state: Nuevo León zip: 66465 country: Mexico name: Ramiro Banda Elizondo role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Medical Care and Research SA de CV city: Merida state: Yucatán zip: 97070 country: Mexico name: Carlos Medina role: PRINCIPAL_INVESTIGATOR lat: 20.97537 lon: -89.61696 facility: EME RED Hospitalaria city: Mérida state: Yucatán zip: 97000 country: Mexico name: Hugo Laviada Molina role: PRINCIPAL_INVESTIGATOR lat: 20.97537 lon: -89.61696 facility: Arké SMO S.A de C.V city: Veracruz zip: 91910 country: Mexico name: Luis Aguilar Espinoza role: PRINCIPAL_INVESTIGATOR lat: 19.18095 lon: -96.1429 facility: Dorado Medical Complex city: Dorado zip: 00646 country: Puerto Rico name: Luis Pagan-Cardona role: PRINCIPAL_INVESTIGATOR lat: 18.45883 lon: -66.26767 facility: Ponce Medical School Foundation Inc. city: Ponce zip: 00716 country: Puerto Rico name: Elizabeth Barranco Santana role: PRINCIPAL_INVESTIGATOR lat: 18.01108 lon: -66.61406 hasResults: False
<\|newrecord\|> nctId: NCT06354647 id: HM20028419 briefTitle: Zirconia-based Primary Anterior Crowns With Retention Grooves Versus Without Retention Grooves overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2027-06-01 date: 2024-04-09 date: 2024-04-09 name: Virginia Commonwealth University class: OTHER briefSummary: The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary anterior teeth. The two different materials of crowns are esthetic crowns with retentive grooves and without retentive crowns. These crowns are placed on the teeth to restore function, esthetics and prevent further caries and infection. conditions: Dental Caries conditions: Tooth Decay studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 75 type: ESTIMATED name: Zirconia-based primary anterior crowns with retention grooves name: Zirconia-based primary anterior crowns without retention grooves measure: Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through clinical outcomes measure: Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through radiographic outcomes measure: Parental satisfaction measure: Child satisfaction measure: Oral health impact during early childhood sex: ALL minimumAge: 2 Years maximumAge: 6 Years stdAges: CHILD facility: Virginia Commonwealth University city: Richmond state: Virginia zip: 23298 country: United States name: Jayakumar Jayaraman, BDS, MDS, FDSRCS, MS, PhD role: CONTACT phone: (804) 828-9095 email: jayaramanj@vcu.edu name: Alpna Khatri role: CONTACT phone: (571) 302-6719 email: khatria4@vcu.edu lat: 37.55376 lon: -77.46026 hasResults: False
<\|newrecord\|> nctId: NCT06354634 id: HM20028439 briefTitle: Resin Polymer (NuSmile BioFlx) Compared to Stainless Steel Crowns (3M ESPE) for Restoration of Primary Molar Teeth overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-07 date: 2027-07 date: 2024-04-09 date: 2024-04-09 name: Virginia Commonwealth University class: OTHER briefSummary: The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary molar teeth. The two different materials of crowns are resin polymer and stainless steel crowns. These crowns are placed on the teeth to restore function and prevent further caries and infection. conditions: Dental Caries conditions: Tooth Decay studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Each participant will receive both interventions. primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Resin polymer (NuSmile Bioflx) crown name: Stainless steel crown measure: The success of Bioflx crown in primary molars in comparisons with stainless steel molars through clinical assessments measure: The success of Bioflx crown in primary molars in comparisons with stainless steel molars through radiographic assessments measure: Parental satisfaction measure: Child satisfaction sex: ALL minimumAge: 3 Years maximumAge: 7 Years stdAges: CHILD facility: Virginia Commonwealth University city: Richmond state: Virginia zip: 23298 country: United States name: Jayakumar Jayaraman role: CONTACT phone: 804-828-2362 email: jayaramanj@vcu.edu lat: 37.55376 lon: -77.46026 hasResults: False
<\|newrecord\|> nctId: NCT06354621 id: D/185/FIMS briefTitle: Impact of Vitamin D Supplementation on Fetomaternal Outcomes in LTBI Pregnant Females acronym: RCT overallStatus: COMPLETED date: 2023-09-01 date: 2024-02-28 date: 2024-03-20 date: 2024-04-09 date: 2024-04-09 name: University of the Punjab class: OTHER briefSummary: The goal of this randomized controlled trial is to see the effect of vitamin D supplementation on fetomaternal outcomes in pregnant females with Latent Tuberculosis infection
The main question\[s\] it aims to answer are:
If Vitamin D supplementation has any impact on maternal outcomes. If Vitamin D supplementation has any impact on fetal outcomes. conditions: Maternal and Child Health studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 99 type: ACTUAL name: Vitamin-D supplementation measure: Pre-Eclampsia (Maternal Outcome) measure: Gestational Diabetes Mellitus (Maternal Outcome) measure: C/Section delivery (Maternal Outcomes) measure: Low Birth Weight (Foetal Outcome) measure: Pre-Term delivery (Foetal Outcome) measure: Apgar Score (Foetal Outcome) measure: Improvement in maternal vitamin-D levels sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: University of the Punjab city: Lahore state: Punjab zip: 54600 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False
<\|newrecord\|> nctId: NCT06354608 id: duygudemirr briefTitle: The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children overallStatus: RECRUITING date: 2023-10-25 date: 2024-04-01 date: 2024-04-30 date: 2024-04-09 date: 2024-04-09 name: University of Yalova class: OTHER briefSummary: The study is conducted based on a randomized controlled experimental design to determine the effect of an audio book and local vibration on intramuscular injection in pediatric emergency unit patients aged 4-6 years on pain and fear. conditions: Procedural Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is an experimental, parallel-group (intervention-control), randomized controlled design primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 120 type: ESTIMATED name: Audio Book Group name: Local Vibration Group measure: Comparison of the pain score values of the groups Pain assesed by Wong-Baker FACES measure: Comparison of the fear score values of the groups measure: Comparison of the fear score values of the groups sex: ALL minimumAge: 4 Years maximumAge: 6 Years stdAges: CHILD facility: University of Yalova status: RECRUITING city: Yalova country: Turkey name: Duygu Demir, PhD role: CONTACT phone: +905053662358 email: duygu.emir@yalova.edu.tr lat: 40.65501 lon: 29.27693 hasResults: False
<\|newrecord\|> nctId: NCT06354595 id: XiamenU1 briefTitle: Feasibility Study of Multidimensional Rehabilitation in the Metaverse overallStatus: RECRUITING date: 2024-03-01 date: 2024-04-30 date: 2024-05-01 date: 2024-04-09 date: 2024-04-09 name: Qu Shen class: OTHER name: The First Affiliated Hospital of Xiamen University briefSummary: The investigators evaluated and optimized the Metaverse multi-dimensional rehabilitation platform based on the use of the Metaverse multi-dimensional rehabilitation platform by colorectal cancer survivors and their families, and finally launched the Metaverse multi-dimensional rehabilitation platform. conditions: Colorectal Neoplasms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 10 type: ESTIMATED name: Multidimensional Rehabilitation in the Metaverse measure: Post-Study System Usability Questionnaire (PSSUQ) Third Edition measure: System Usability Scale (SUS) measure: Semi-structured interview sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yuru Hu status: RECRUITING city: Xiamen state: Fujian zip: 361005 country: China name: Yuru HU role: CONTACT phone: 18189530895 email: 15903017593@163.com lat: 24.47979 lon: 118.08187 hasResults: False
<\|newrecord\|> nctId: NCT06354582 id: 2024-085-01 briefTitle: Effect of Intravenous Vitamin C on Intrapartum Maternal Fever After Epidural Labor Analgesia acronym: EIVCIMFAELA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2025-02 date: 2024-04-09 date: 2024-04-09 name: Kunyue Li class: OTHER name: Third Affiliated Hospital of Zhengzhou University briefSummary: This study aims to explore the effect of intravenous vitamin C infusion on intrapartum fever after epidural labor analgesia, to reduce the impact of intrapartum fever on maternal and infant, improve maternal and infant outcomes, and provide a reference for clinical preventive medication. conditions: Obstetric Labor Complications conditions: Fever studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parturients are randomly assigned to either vitamin C(1,2,3) or control. The vitamin C group received 1 g, 2g, and 3g of vitamin C intravenously respectively and the control group received normal saline, administered after the induction of epidural labor anesthesia. There will be 100 cases in each group. The infusion speed will be set at 5ml/min. primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 400 type: ESTIMATED name: Vitamin C Injection name: Normal saline measure: Intrapartum fever or not measure: The temperature of parturients measure: The duration of intrapartum fever measure: Complete blood count indicators measure: Visual analogue scale(VAS) measure: Amount of total analgesics measure: Side effects on mothers measure: the duration of total labor measure: Incidence of rupture of membranes measure: Delivery characteristics 2 measure: Record the weight of the baby. measure: Record the gender of the baby. measure: Apgar score measure: the incidence of fetal distress measure: Record the infant ward administration. sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06354569 id: 2022.232 briefTitle: Risk Factors and Risk Grading Prediction of Perioperative Respiratory Adverse Events in Children overallStatus: RECRUITING date: 2024-12-31 date: 2024-12-31 date: 2024-12-31 date: 2024-04-09 date: 2024-04-09 name: Sichuan Provincial People's Hospital class: OTHER briefSummary: to explore the risk factors of perioperative respiratory adverse events in children, and to establish a risk prediction model of perioperative respiratory adverse events in children conditions: Perioperative Respiratory Adverse Events studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 600 type: ESTIMATED measure: The occurrence of perioperative respiratory adverse events sex: ALL minimumAge: 1 Month maximumAge: 12 Years stdAges: CHILD facility: Sichuan provincial Peopel'Hospital status: RECRUITING city: Chengdu state: Sichuan country: China name: Yanyu Liu role: CONTACT phone: +8613438348895 email: 43197113@qq.com name: Ting Xu role: CONTACT phone: +8317708130267 lat: 30.66667 lon: 104.06667 hasResults: False
<\|newrecord\|> nctId: NCT06354556 id: HRS-1893-102 briefTitle: Effect of Verapamil Tablets on the Pharmacokinetic of HRS-1893 Tablets in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05-05 date: 2024-05-30 date: 2024-04-09 date: 2024-04-09 name: Shandong Suncadia Medicine Co., Ltd. class: INDUSTRY briefSummary: The purpose of this phase Ⅰ study is to evaluate the effect of oral verapamil tablets on the pharmacokinetics of HRS-1893 in healthy subjects. conditions: Obstructive Hypertrophic Cardiomyopathy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single center, open, single arm, fixed sequence primaryPurpose: TREATMENT masking: NONE count: 14 type: ESTIMATED name: HRS-1893 tablet name: Verapamil tablet measure: Maximum observed serum concentration (Cmax) for HRS-1893 after Single dose measure: Area under the plasma concentration versus time curve from time zero to last measurable timepoint (AUC0-t) for HRS-1893 after single dose measure: Area under the plasma concentration versus time curve from time zero extrapolated to infinity (AUC0-inf) for HRS-1893 after single dose measure: Time to maximum observed serum concentration (Tmax) for HRS-1893 after single dose measure: Elimination half-life (T1/2) for HRS-1893 after single dose measure: Apparent oral clearance (CL/F) for HRS-1893 after single dose measure: Apparent volume of distribution (Vz/F) for HRS-1893 after single dose measure: Accumulated amount of excretion (Ae) for HRS-1893 after single dose measure: Urinary excretion fraction（fe）for HRS-1893 after single dose measure: Renal clearance（CLr）for HRS-1893 after single dose measure: Number of subjects with adverse events and the severity of adverse events sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06354543 id: CA01-TK-ARTHRO briefTitle: Arthroplasty Cements Outcomes - A Post-market Follow-up overallStatus: RECRUITING date: 2020-12-16 date: 2035-12 date: 2045-12 date: 2024-04-09 date: 2024-04-09 name: Teknimed class: INDUSTRY briefSummary: A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all Teknimed Arthroplasty range of products: CEMFIX® and GENTAFIX® bone cements families and CEMSTOP® cement restrictor, and all their private labels.
Teknimed bone cements and cement restrictor are legacy products, some marketed for more than 20 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting.
The study is a retrospective and prospective global, single arm, non-controlled, multicentric, ambispective observational study. Patients will be followed as per local standard medical care of the site. conditions: Arthroplasty studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1050 type: ESTIMATED name: Cemented joint arthroplasty measure: Survival rate measure: Superficial and/or deep postoperative infection rate. measure: Pain Level measure: Patients' satisfaction measure: Restoration of function measure: Evaluation of function and radiological outcomes measure: Complications rate measure: Antalgic consumption measure: Restoration of function measure: Restoration of function measure: Adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique du Vivarais status: RECRUITING city: Aubenas state: Auvergne-rhône-alpes zip: 07200 country: France name: Michel MILAIRE, MD role: CONTACT email: michel.milaire@yahoo.com name: Michel MILAIRE, MD role: PRINCIPAL_INVESTIGATOR lat: 44.62006 lon: 4.38994 facility: Clinique du Val d'Ouest status: RECRUITING city: Ecully state: Auvergne-rhône-alpes zip: 69130 country: France name: Benoît GIRAUD, MD role: CONTACT email: b.giraud@chirortho-valdouest.fr name: Benoît GIRAUD, MD role: PRINCIPAL_INVESTIGATOR lat: 45.77726 lon: 4.77481 facility: Cabinet de consultation status: RECRUITING city: Evreux state: Eure zip: 27000 country: France name: Edouard DECRETTE, MD role: CONTACT email: decrette.edouard@gmail.com name: Edouard DECRETTE, MD role: PRINCIPAL_INVESTIGATOR lat: 49.02414 lon: 1.15082 facility: Clinique du Dr Henri Guillard status: RECRUITING city: Coutances state: Normandie zip: 50200 country: France name: Olivier COSSART, MD role: CONTACT email: o.cossart@hotmail.fr name: Olivier COSSART, MD role: PRINCIPAL_INVESTIGATOR lat: 49.05 lon: -1.43333 facility: Clinique de l'Atlantique status: RECRUITING city: Puilboreau state: Nouvelle-aquitaine zip: 17138 country: France name: Cédric BOUQUET, MD role: CONTACT email: docteurbouquet@gmail.com name: Cédric BOUQUET, MD role: PRINCIPAL_INVESTIGATOR lat: 46.1862 lon: -1.11797 facility: Hôpital Européen Marseille status: RECRUITING city: Marseille state: Provence-alpes-cote D'azur zip: 13003 country: France name: Maxime MUNIER, MD role: CONTACT email: dr.maxime.munier@gmail.com name: Maxime MUNIER, MD role: PRINCIPAL_INVESTIGATOR lat: 43.29551 lon: 5.38958 facility: Ospedale Santissima Annunziata status: RECRUITING city: Cento state: Emilie-Romagne zip: 44042 country: Italy name: Luca CASTAGNINI, MD role: CONTACT email: luca.castagnini@ausl.fe.it name: Luca CASTAGNINI, MD role: PRINCIPAL_INVESTIGATOR lat: 44.73099 lon: 11.28716 facility: Instituto Ortopedico Rizzoli status: RECRUITING city: Bologna state: Émilie-Romagne zip: 40136 country: Italy name: Stefano ZAFFAGNINI, MD role: CONTACT email: stefano.zaffagnini@unibo.it name: Stefano ZAFFAGNINI, MD role: PRINCIPAL_INVESTIGATOR lat: 44.49381 lon: 11.33875 hasResults: False
<\|newrecord\|> nctId: NCT06354530 id: 2023 (315) briefTitle: A Study of Neoadjuvant Therapy for the Treatment of Patients With Locally Advanced Esophageal Squamous Cell Carcinoma overallStatus: RECRUITING date: 2024-03-08 date: 2025-12-31 date: 2026-12-31 date: 2024-04-09 date: 2024-04-09 name: Army Medical Center of PLA class: OTHER_GOV briefSummary: The goal of this interventional study is to compare the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma. The main question it aims to answer is: To evaluate the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma and to explore the optimal preoperative neoadjuvant treatment regimen for esophageal squamous cell carcinoma. conditions: Neoadjuvant Therapy conditions: Esophageal Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 266 type: ESTIMATED name: anlotinib name: Thoracic radiotherapy measure: Pathological complete response (pCR), Major pathological response (MPR) measure: Major pathological response (MPR) measure: Objective response rate (ORR) measure: 3-year disease free survival measure: R0 excision rate measure: 3-year overall survival sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Army Medical Center of PLA status: RECRUITING city: Chongqing state: None Selected country: China name: Mengxia Li role: CONTACT phone: +86-18580408265 email: mengxia.li@outlook.com name: Xiao Yang role: CONTACT phone: +86-19923257675 email: yangxiao625@outlook.com lat: 29.56278 lon: 106.55278 hasResults: False

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