Record
stringlengths 1
197k
|
|---|
<|newrecord|> nctId: NCT06294470 id: 01-2023 briefTitle: Efficacy of Stapled Hemorrhoidopexy for the Treatment of Obstructive Defecation Syndrome overallStatus: COMPLETED date: 2023-05-01 date: 2023-11-30 date: 2023-12-15 date: 2024-03-05 date: 2024-03-05 name: Universidad Central de Venezuela class: OTHER briefSummary: The objective of this study is to assess the efficiency of the procedure for hemorrhoidal prolapse and pexia in alleviating symptoms of defecatory obstruction among patients with grade II to IV mucohemorrhoidal prolapse. conditions: Hemorrhoids conditions: Defecation Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 34 type: ACTUAL name: Ballon expulsion test name: Colonic transit time name: Stapled hemorrhodopexy measure: Postoperative improvement of symptoms of defecatory obstruction measure: Postoperative change of the balloon expulsion test measure: Postoperative change of the colonic transit time sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Domingo Luciani city: Caracas state: Miranda zip: 1073 country: Venezuela lat: 10.48801 lon: -66.87919 hasResults: False
|
<|newrecord|> nctId: NCT06294457 id: CI-2024-480 briefTitle: Effectiveness of Non-invasive Neuromodulation for Intestinal Transit in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-03 date: 2024-06 date: 2024-03-05 date: 2024-03-05 name: Universidad Europea de Madrid class: OTHER briefSummary: Objectives
|
Main objective:
|
Assess the effectiveness of non-invasive neuromodulation treatment (NESA) for the management of constipation in patients without diagnosed pathology in Spain
|
Secondary objectives:
|
Evaluate the improvement in sleep quality Analyze the improvement in blood pressure quality Measure the improvement in cortisol quality Determine if there is an improvement in heart rate conditions: Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: The device will be placed with no current. This type of neuromodulation gives no feeling at all to the patient while administred, so there is no way for the patient to know if the apparatus is connected or not. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Non-Invasive Neuromodulation NESA measure: Quality of life by constipation (CVE-20) measure: Sleep Quality measure: Cardiac Frecuency measure: Arterial pressure sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06294444 id: REC/RCR&AHS/23/0741 briefTitle: Comparison of Constraint Induced Movement Therapy and Mirror Therapy overallStatus: RECRUITING date: 2023-12-01 date: 2024-03-15 date: 2024-03-15 date: 2024-03-05 date: 2024-03-05 name: Riphah International University class: OTHER briefSummary: Hemiplegia in infants and children is a type of Cerebral Palsy that results from damage to the part (hemisphere) of the brain that controls muscle movements. This damage may occur before, during or shortly after birth. The term hemiplegia means that the paralysis is on one vertical half of the body. The aim of this study will be the to know the effect of mCIMT with and without mirror therapy on upper limb function in children with hemiplegic cerebral palsy. A randomized control trial will be conducted at Sheikh Zayed Hospital, RYK through convenience sampling technique on 30 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. Group A will be treated with mCIMT and Group B will be treated with mCIMT and mirror therapy. Outcome measure will be conducted through pain and disability questionnaire after 6 weeks. Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. mCIMT with and without mirror therapy will be applied in patients with hemiplegic cerebral palsy to see the effect on upper limb function. conditions: Hemiplegic Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Control Trial primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Participants will get separate treatment protocol and possible efforts will be put to mask the both groups about their treatment whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Constraint Induced Movement Therapy name: Mirror therapy measure: fine motor skills sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Imran Amjad status: RECRUITING city: Lahore state: Punjab zip: 54000 country: Pakistan name: Muhammad Asif Javed, MS role: CONTACT phone: 923224209422 email: a.javed@riphah.edu.pk name: Imran Amjad, PhD role: CONTACT phone: 923224390125 email: imran.amjad@riphah.edu.pk name: Hurriya Sehar, MS* role: PRINCIPAL_INVESTIGATOR lat: 31.558 lon: 74.35071 facility: Riphah International University status: RECRUITING city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False
|
<|newrecord|> nctId: NCT06294431 id: RADX-P-2406 briefTitle: Radicle Clarity 24: A Study of Health and Wellness Products on Cognitive Function and Related Health Outcomes overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-22 date: 2024-05 date: 2024-07 date: 2024-03-05 date: 2024-04-24 name: Radicle Science class: INDUSTRY briefSummary: A randomized, double-blind, placebo-controlled direct-to-consumer study of health and wellness products on cognitive function and related health outcomes conditions: Cognitive Function studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be stratified based on their gender assigned at birth and health outcome score during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm. primaryPurpose: OTHER masking: DOUBLE maskingDescription: The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 1001 type: ESTIMATED name: Placebo Control Form 1 name: Clarity Active Study Product 1.1 Usage name: Placebo Control Form 2 name: Clarity Active Study Product 2.1 Usage measure: Change in cognitive function measure: Change in fatigue measure: Change in sleep-related impairment measure: Minimal clinical importance difference (MCID) in cognitive function measure: Change in mood (emotional distress-depression) measure: Change in concentration of at-home (direct-to-consumer) specimen assays either saliva, blood or stool sex: ALL minimumAge: 21 Years maximumAge: 105 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Radicle Science, Inc city: Del Mar state: California zip: 92014 country: United States lat: 32.95949 lon: -117.26531 hasResults: False
|
<|newrecord|> nctId: NCT06294418 id: 1-037-23 briefTitle: FCI in Post-operative Low Grade Gliomas overallStatus: RECRUITING date: 2024-02-15 date: 2025-03 date: 2025-03 date: 2024-03-05 date: 2024-03-05 name: NHS Grampian class: OTHER_GOV name: University of Aberdeen briefSummary: The aim of this pilot study is to explore the utility of a new imaging technique, called Field Cycling Imaging (FCI), in postoperative low grade gliomas.
|
The main question it aims to answer is if FCI can differentiate subtypes of low grade gliomas. Participants will have one FCI scan. conditions: Glioma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ESTIMATED name: Field Cycling Imaging (FCI) measure: Differentiation of sub-types of low grade glioma assessed by Field Cycling Imaging (FCI) T1 dispersion profiles sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Aberdeen Royal Infirmary status: RECRUITING city: Aberdeen zip: AB25 2ZD country: United Kingdom name: Arnab K Rana, Dr role: CONTACT phone: +441224438363 email: arnab.rana@abdn.ac.uk lat: 57.14369 lon: -2.09814 hasResults: False
|
<|newrecord|> nctId: NCT06294405 id: 24-0010 briefTitle: Intraocular Lens Implant Registry Study overallStatus: RECRUITING date: 2024-02-21 date: 2029-02-14 date: 2029-02-14 date: 2024-03-05 date: 2024-03-05 name: University Hospital Augsburg class: OTHER briefSummary: The goal of this registry study is to optimize the results with intraocular lens implants used in cataract surgery. conditions: Intraocular Lens Complication conditions: Intraocular Lens Rotation conditions: Intraocular Lens Associated Postoperative Inflammation conditions: Lens Opacities studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 500 type: ESTIMATED name: Intraocular lens Implantation measure: Functional results with different Intraocular lenses measure: Contrast sestivitiy with different Intraocular lenses measure: Anatomical results. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Augsburg status: RECRUITING city: Augsburg country: Germany name: Isabella Baur, MD role: CONTACT lat: 48.37154 lon: 10.89851 hasResults: False
|
<|newrecord|> nctId: NCT06294392 id: 90FA3010 briefTitle: KEEP Connecting Kin acronym: KEEP-CK overallStatus: RECRUITING date: 2024-02-13 date: 2026-04 date: 2026-04 date: 2024-03-05 date: 2024-03-05 name: Oregon Social Learning Center class: OTHER name: Office of Planning, Research & Evaluation briefSummary: The current study provides a unique opportunity to conduct a summative evaluation of the KEEP Connecting Kin (KEEP-CK) program by leveraging extant relationships with Oregon's Child Welfare System (CWS), Self-Sufficiency Program (SSP), and our community partners to address the needs of informal kinship families and the youth in their care. Specifically, a randomized "services-as-usual" (SAU) waitlist control design plus qualitative methods will be used to evaluate the immediate (post-intervention) and sustained (10 month) impacts of the KEEP-CK program on child, adult, and service utilization outcomes, and prevention of entry into the CWS. conditions: Internalizing Behavior conditions: Externalizing Behavior conditions: Child Permanency conditions: Parenting conditions: Parent Stress conditions: Service Utilization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Informal kinship caregivers will be randomly assigned to receive the KEEP-CK program either immediately or after waiting 10 months using a randomized blocked design. Blocking factors include: (a) the length of time that the child has been living in informal kinship care (\<=6 months, 7 months to \<2 years, or \>=2 years); (b) child age (4 to 12 years, or 13+ years); and (c) low (or not low) resource families, defined by an annual household income below (or above) 150% of the federal poverty level. primaryPurpose: PREVENTION masking: NONE count: 192 type: ESTIMATED name: KEEP-CK measure: Mean change in youth well-being (i.e., behavioral and emotional functioning, including child internalizing and externalizing behaviors) measure: Mean change in child permanency (i.e., placement stability and permanency of placements) measure: Mean change in parenting practices and parent/caregiver stress. measure: Mean change in parent/caregiver stress. measure: Mean change in parenting practices. measure: Mean change in parents' use of services from multiple systems (financial, educational, mental health, medical, legal) sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Oregon Center Learning Center status: RECRUITING city: Eugene state: Oregon zip: 97401 country: United States name: Courtenay Padgett role: CONTACT phone: 541-485-2711 email: CourtP@oslc.org lat: 44.05207 lon: -123.08675 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2023-07-11 uploadDate: 2024-02-27T15:36 filename: SAP_000.pdf size: 239212 hasResults: False
|
<|newrecord|> nctId: NCT06294379 id: OUH_SDM briefTitle: Shared Decision Making in Melanoma Patients Receiving Adjuvant Therapy overallStatus: RECRUITING date: 2022-03-01 date: 2024-12-30 date: 2024-12-30 date: 2024-03-05 date: 2024-03-05 name: Odense University Hospital class: OTHER name: University of Copenhagen name: Aarhus University Hospital name: Aalborg University Hospital briefSummary: This study aims to develop test and evaluate a Patient Decision Aid called "The Decision Helper" among melanoma patients eligible for adjuvant treatment.
|
* Is the Decision Helper an acceptable tool for patients and clinicians and is it feasible in clinical practice?
|
* Are there any differences in the levels of decisional regret in the patients who have not used the Decision Helper (pre-implementation) compared to the ones who have (post-implementation? conditions: Malignant Melanoma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED measure: Development of a Patient Decision Aid "The Decision Helper" for melanoma patients receiving adjuvant theory measure: Evaluation of the "The Decision Helper" sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Odense University Hospital status: RECRUITING city: Odense C zip: 5000 country: Denmark name: Lærke Tolstrup role: CONTACT phone: 40295129 email: lctolstrup@mail.dk lat: 55.39594 lon: 10.38831 hasResults: False
|
<|newrecord|> nctId: NCT06294366 id: MenoufiaU2022 briefTitle: Bipolar Transurethral Enucleation Versus Resection in the Treatment of Benign Prostatic Hyperplasia: a Comparative Study overallStatus: RECRUITING date: 2022-06-12 date: 2024-04-12 date: 2024-06-12 date: 2024-03-05 date: 2024-03-05 name: Menoufia University class: OTHER briefSummary: Benign prostatic hyperplasia (BPH) is a common chronic progressive disease resulting in the enlargement of the prostate gland and bladder outlet obstruction in aging men .
|
Because of the increasing aged population and advancements in diagnostic tools, the incidence and importance of BPH have increased . BPH can be treated either with watchful waiting, drug therapy, or surgery being the most effective treatment option for BPH .
|
Transurethral resection of the prostate (TURP) has been recognized as the standard treatment for BPH with morbidity rate varies from 18% and 26% Until now, only open prostatectomy and transurethral Holmium laser enucleation of the prostate (HoLEP) have shown an equal efficacy and durability compared to TURP conditions: Prostatic Hyperplasia conditions: Prostate Enucleation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 52 type: ESTIMATED name: Bipolar Bowa device measure: Assessing and comparing the safety, the surgical efficacy and peri-operative morbidity of bipolar enucleation of the prostate and bipolar transurethral resection of the prostate for the treatment of patients with symptomatizing prostates. sex: MALE minimumAge: 50 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of medicine status: RECRUITING city: Shibīn Al Kawm state: Menoufia zip: 32866 country: Egypt name: Baher M Abdelraouf, MD role: CONTACT phone: +201069973254 email: maar2002002@gmail.com lat: 30.55258 lon: 31.00904 hasResults: False
|
<|newrecord|> nctId: NCT06294353 id: WCTP-ED-B-01 briefTitle: Study of Efficacy and Safety of WELT-ED for Eating Disorder (WCTP-ED-B-01) overallStatus: RECRUITING date: 2023-03-29 date: 2024-06-30 date: 2024-08-30 date: 2024-03-05 date: 2024-03-06 name: WELT corp class: INDUSTRY briefSummary: The purpose of this clinical trial is to evaluate the safety and efficacy of a digital therapeutic device (WELT-ED) based on Cognitive Behavioral Therapy (CBT) for the treatment of eating disorders.
|
The main questions it aims to answer are:
|
* Is WELT-ED as effective as standard treatment in reducing the symptoms of eating disorders?
|
* Is the WELT-ED safe for use in the target population without causing adverse effects?
|
Participants will:
|
* Undergo assessments to determine their baseline health status and severity of eating disorder symptoms.
|
* Use WELT-ED or receive standard treatment as directed for the duration of the study period (8 weeks).
|
* Participate in assessments to monitor changes in their eating disorder symptoms and any potential side effects. conditions: Eating Disorders conditions: Binge Eating conditions: Binge-Eating Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 134 type: ESTIMATED name: WELT-ED (CBT based DTx) name: Standard Treatment measure: Binge Eating Frequency measure: Eating Disorder Examination Questionnaire (EDE-Q) measure: Clinical Impairment Assessment (CIA) measure: Patient health questionnaire-9 (PHQ-9) measure: Generalized anxiety disorder 7-item scale (GAD-7) measure: The EuroQol Visual Analogue Scale (EQ-VAS) measure: Clinical Global Impression of Improvement (CGI-I) measure: Clinical Global Impression of Severity (CGI-S) measure: Adherence (Compliance) to WELT-ED (applicable only to WELT-ED Group) measure: BMI (Body Mass Index) measure: WELT-ED App Usage Satisfaction (applicable only to WELT-ED Group) measure: App-Based Lifestyle and Eating Data (applicable only to WELT-ED Group) measure: Change in Regular Meal Frequency (applicable only to WELT-ED Group) sex: ALL minimumAge: 19 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital status: RECRUITING city: Seoul zip: 03080 country: Korea, Republic of name: soohee Choi role: CONTACT phone: 0215885700 email: soohchoi@snu.ac.kr lat: 37.566 lon: 126.9784 facility: Severance Hospital status: RECRUITING city: Seoul zip: 03722 country: Korea, Republic of name: Young Chul Jung, MD role: CONTACT phone: 82-2-2228-1622 email: eugenejung@yuhs.ac lat: 37.566 lon: 126.9784 hasResults: False
|
<|newrecord|> nctId: NCT06294340 id: 1322-IX/42 briefTitle: Noise, Oxidative Stress and Cardiovascular System acronym: NOXYCARD overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2027-12 date: 2028-12 date: 2024-03-05 date: 2024-03-05 name: University of Belgrade class: OTHER briefSummary: Environmental noise represents a health problem for at least one in five citizens of the European Union. Noise exposure leads to the development of arterial hypertension, myocardial infarction, stroke, and obesity. Given the limited information on noise exposure and noise effects on humans in the Republic of Serbia, the overall objective of NOXYCARD is to collect environmental noise levels data; to identify long-term and short-term noise effects on the cardiovascular system; and to evaluate the levels of blood stress hormones, oxidative stress, and inflammation in individuals with normal body weight and individuals with obesity. conditions: Noise; Adverse Effect conditions: Noise Exposure studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 150 type: ESTIMATED name: Exposure to loud pre-recorded road traffic noise measure: Systolic blood pressure measure: Concentration of stress hormone measure: Diastolic blood pressure measure: Concentration of inflammation parameters sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine, University of Belgrade city: Belgrade state: Beograd zip: 11040 country: Serbia lat: 44.80401 lon: 20.46513 hasResults: False
|
<|newrecord|> nctId: NCT06294327 id: EC23027 briefTitle: RESTART the Prevention of Pressure Ulcers: Comparing the Effectiveness and Cost of a Reactive Static Air Mattress and Alternating Air Pressure Mattress overallStatus: RECRUITING date: 2024-01-22 date: 2025-01-01 date: 2025-04-30 date: 2024-03-05 date: 2024-03-07 name: Vitaz class: OTHER name: University Ghent briefSummary: Pressure ulcers are a global issue and substantial concern for healthcare systems. A review of the literature between January 2000 and December 2012 has revealed that prevalence rate of pressure ulcers in aged care facilities were between 4.1% and 32.2%, and the incidence rates ranged from 1.9% to 59%. Similarly, a systematic review reported that the prevalence of pressure ulcer varied between 0.3% and 46%, and the incidence of pressure ulcer ranged from 0.8% to 34%. Most epidemiological data were obtained from hospitals (38.7%) and institutional long-term care facilities (29.7%).
|
The costs associated with pressure ulcers are considerable. According to the Agency for Healthcare Research \& Quality (2011), the US healthcare system has allocated approximately $ 9.1 - $ 11.6 billion annually for the health care cost of pressure ulcer. In addition to direct treatment-related costs, the development of pressure ulcer also results in litigation and government penalties, and affects hospital performance metrics. A systematic review has reported that the cost for treatment of pressure ulcer was higher than its prevention. That is, the cost per patient per day ranged from € 1.71 to € 470.49 (for treatment) and from € 2.65 to € 87.57 (for prevention) across all settings.
|
This randomized controlled trial will be performed in a general hospital in a random sample of 308 patients (nursing wards geriatric n=3 and orthopedic (n=3)) who are at high risk of developing pressure ulcers. Patients will be included in the study for a period \> 2 hospitalisation days. Skin assessment and risk factor registration will be done on a daily base by the ward nurses. Reliability checks and time measurements will be completed by the researcher. conditions: Pressure Injury conditions: Pressure Ulcer conditions: Decubitus Ulcer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 308 type: ESTIMATED name: Reactive static air support surfaces measure: Incidence of pressure ulcer, category > I measure: Cost of alternating air pressure mattress compared to reactive static air support surfaces measure: Patient comfort sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vitaz (General Hospital) status: RECRUITING city: Sint-Niklaas state: East Flanders zip: 9100 country: Belgium name: Brecht Serraes, PhD role: CONTACT phone: +3237602039 email: Brecht.Serraes@vitaz.be name: Peter Desmet, MD role: CONTACT lat: 51.16509 lon: 4.1437 hasResults: False
|
<|newrecord|> nctId: NCT06294314 id: 1982669-3 briefTitle: Return to Play After ACL Reconstruction With Bone Marrow Aspirate, DBM, and an Internal Brace overallStatus: RECRUITING date: 2024-02-26 date: 2026-08-01 date: 2028-07-01 date: 2024-03-05 date: 2024-03-05 name: Marshall University class: OTHER name: Arthrex, Inc. briefSummary: The Investigators are studying the effect of an ACL reconstruction on return to play by capturing outcome measures and biomechanics information. conditions: Anterior Cruciate Ligament Rupture studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 450 type: ESTIMATED name: Fertilized ACL measure: Return to play measure: Biomechanics testing measure: MRI findings measure: Rerupture sex: ALL minimumAge: 14 Years maximumAge: 26 Years stdAges: CHILD stdAges: ADULT facility: Marshall University status: RECRUITING city: Huntington state: West Virginia zip: 25755 country: United States name: chad d lavender, md role: CONTACT phone: 304-552-6514 email: doclav@gmail.com name: Kara Cipriani, np role: CONTACT phone: 304-541-5316 email: cipriani6@marshall.edu lat: 38.41925 lon: -82.44515 hasResults: False
|
<|newrecord|> nctId: NCT06294301 id: P10-LP005-01 briefTitle: A Study of Single and Multiple Doses of LP-005 in Healthy Adult Participants overallStatus: RECRUITING date: 2023-11-19 date: 2024-04-30 date: 2024-10-30 date: 2024-03-05 date: 2024-03-05 name: Longbio Pharma class: INDUSTRY briefSummary: The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-005 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-005 and Part 2, multiple ascending dose (MAD). conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH) studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 78 type: ESTIMATED name: LP-005 Dose 1 (Single) name: LP-005 Dose 2 (Single) name: LP-005 Dose 3 (Single) name: LP-005 Dose 4 (Single) name: LP-005 Dose 5 (Single) name: LP-005 Dose 6 (Single) name: Placebo (Single) name: LP-005 Dose 7 (Multiple) name: LP-005 Dose 8 (Multiple) name: LP-005 Dose 9 (Multiple) name: Placebo (Multiple) measure: Adverse events measure: Time to peak concentration (Tmax) of LP-005 measure: Maximum concentration (Cmax) of LP-005 measure: Elimination half-life (t1/2) of LP-005 measure: Area under the concentration-time curve (AUC0-t) of LP-005 measure: Apparent clearance rate (CL/F) of LP-005 measure: Assessment of immunogenicity measure: Assessment of complement C5 activity measure: Assessment of complement C3b activity sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Shanghai Public Health Clinical Center status: RECRUITING city: Shanghai state: Shanghai country: China name: Yun Ling role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False
|
<|newrecord|> nctId: NCT06294288 id: P-10-LP003-2022-01 briefTitle: A Study of Single and Multiple Doses of LP-003 in Healthy Adult Participants overallStatus: ACTIVE_NOT_RECRUITING date: 2021-07-01 date: 2023-09-03 date: 2024-03-15 date: 2024-03-05 date: 2024-03-05 name: Longbio Pharma class: INDUSTRY briefSummary: The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-003 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-003 and Part 2, multiple ascending dose (MAD). conditions: Chronic Spontaneous Urticaria studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: LP-003 Dose 1 (Single) name: LP-003 Dose 2 (Single) name: LP-003 Dose 3 (Single) name: LP-003 Dose 4 (Single) name: LP-003 Dose 5 (Single) name: Placebo (Single) name: LP-003 Dose 6 (Multiple) name: LP-003 Dose 7 (Multiple) name: LP-003 Dose 8 (Multiple) name: Placebo (Multiple) measure: Adverse events measure: Time to peak concentration (Tmax) of LP-003 measure: Maximum concentration (Cmax) of LP-003 measure: Elimination half-life (t1/2) of LP-003 measure: Area under the concentration-time curve (AUC0-t) of LP-003 measure: Apparent clearance rate (CL/F) of LP-003 measure: Assessment of immunogenicity measure: Assessment of total immunoglobulin E (IgE) measure: Assessment of free IgE sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Shanghai General Hospital city: Shanghai state: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False
|
<|newrecord|> nctId: NCT06294275 id: P-10-LP001-2022-01 briefTitle: A Study of Single and Multiple Dose Administration of LP-001 in Healthy Subjects overallStatus: ACTIVE_NOT_RECRUITING date: 2022-09-16 date: 2024-01-02 date: 2024-04-06 date: 2024-03-05 date: 2024-03-05 name: Longbio Pharma class: INDUSTRY briefSummary: The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-001 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-001 and Part 2, multiple ascending dose (MAD). conditions: Myelodysplastic Syndrome (MDS) studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 68 type: ESTIMATED name: LP-001 Dose 1 (Single) name: LP-001 Dose 2 (Single) name: LP-001 Dose 3 (Single) name: LP-001 Dose 4 (Single) name: LP-001 Dose 5 (Single) name: LP-001 Dose 6 (Single) name: Placebo (Single) name: LP-001 Dose 7 (Multiple) name: LP-001 Dose 8 (Multiple) name: Placebo (Multiple) measure: Adverse events measure: Time to peak concentration (Tmax) of LP-001 measure: Maximum concentration (Cmax) of LP-001 measure: Elimination half-life (t1/2) of LP-001 measure: Area under the concentration-time curve (AUC0-t) of LP-001 measure: Apparent clearance rate (CL/F) of LP-001 measure: Assessment of immunogenicity measure: Assessment of hemoglobin (Hb) change measure: Assessment of red blood cell (RBC) count change measure: Assessment of reticulocyte (Rtc) count change sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Shanghai Public Health Clinical Center city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False
|
<|newrecord|> nctId: NCT06294262 id: 2023-508230-33-00 briefTitle: Safety, Tolerability, Immunogenicity and Immunological Mechanisms of TETRALITE, a Novel Seasonal Influenza Vaccine acronym: TETRALITE-Ib overallStatus: RECRUITING date: 2024-01-29 date: 2024-09 date: 2025-03 date: 2024-03-05 date: 2024-03-05 name: LiteVax BV class: INDUSTRY name: University Hospital, Ghent name: HarmonyCR, Melle, Belgium briefSummary: The effect of LiteVax Adjuvant supplemented to licensed seasonal influenza vaccine on safety and immunogenicity will be investigated in both younger and older healthy participants. Local and systemic adverse events, and humoral and cellular immune responses will be determined at different time intervals after a single administration. Mode of action of LiteVax Adjuvant will examined by detailed genetic analysis and omics approaches such as transcriptomics, proteomics and metabolomics. conditions: Vaccination Reaction studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 84 type: ESTIMATED name: TETRALITE measure: Characterise local and systemic AEs, and SAEs, pIMDs and AESIs to TETRALITE measure: Characterise clinical hematology and biochemistry to TETRALITE measure: Characterise HI antibody response to the four vaccine strains of TETRALITE in serum measure: Characterise MN antibody response to the four vaccine strains of TETRALITE in serum measure: Characterise mechanisms of action of LiteVax Adjuvant measure: Characterise T-cell responses to TETRALITE in PBMCs measure: Characterise B-cell response to TETRALITE in PBMCs measure: Characterise molecular features of vaccine-induced immunity by RNA sequencing measure: Characterise antibody response to influenza virus antigens other than hemaglutunin of the vaccine strains of TETRALITE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Gent status: RECRUITING city: Ghent zip: 9000 country: Belgium lat: 51.05 lon: 3.71667 hasResults: False
|
<|newrecord|> nctId: NCT06294249 id: 20045125 briefTitle: Pain Severity in Flapless Dental Implant Placement Using Laser overallStatus: COMPLETED date: 2020-01-01 date: 2023-12-01 date: 2023-12-04 date: 2024-03-05 date: 2024-03-26 name: Shiraz University of Medical Sciences class: OTHER name: Shahid Beheshti University of Medical Sciences briefSummary: The goal of this split-mouth randomized clinical trial study was to investigate the effect of using a laser on pain and discomfort following flapless dental implant surgery. It was hypothesized that laser did not have any impact on post-op pain. Therefore, the study aimed to compare pain and discomfort following flapless dental implant surgeries with or without a laser. conditions: Jaw, Edentulous, Partially studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Laser-induced Incision name: Punch Incision name: Implant Placement measure: Pain Severity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: shiraz University of medical sciences city: Shiraz state: Fars country: Iran, Islamic Republic of lat: 29.61031 lon: 52.53113 hasResults: False
|
<|newrecord|> nctId: NCT06294236 id: SC291-102 briefTitle: Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM) overallStatus: RECRUITING date: 2024-04 date: 2027-12 date: 2028-03 date: 2024-03-05 date: 2024-04-01 name: Sana Biotechnology class: INDUSTRY briefSummary: SC291-102 is a Phase 1 study to evaluate SC291 safety and tolerability, preliminary clinical response, cellular kinetics and exploratory assessments for subjects with severe autoimmune diseases. conditions: Lupus Erythematosus conditions: Systemic Lupus Erythematosus conditions: SLE (Systemic Lupus) conditions: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis conditions: Granulomatous Polyangiitis conditions: Microscopic Polyangiitis studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: SC291 measure: Evaluate safety and tolerability of SC291 measure: Evaluate preliminary clinical response to SC291 measure: Evaluate preliminary clinical response to SC291 measure: Evaluate preliminary clinical response to SC291 measure: Evaluate preliminary clinical response to SC291 measure: Evaluate preliminary clinical response to SC291 (LN and ERL Cohorts) measure: Evaluate preliminary clinical response to SC291 (LN Cohort) measure: Evaluate preliminary clinical response to SC291 (ERL Cohort) measure: Evaluate preliminary clinical response to SC291 (AAV Cohort) measure: Evaluate preliminary clinical response to SC291 (AAV Cohort) measure: Evaluate cellular kinetics and persistence of SC291 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Swedish Medical Center status: RECRUITING city: Seattle state: Washington zip: 98122 country: United States name: Richie Satira, RN role: CONTACT phone: 206-386-2000 email: richard.satira@swedish.org name: Danna Caceres-Reyes, RN role: CONTACT phone: 206-386-2000 email: Danna.Caceres-Reyes@swedish.org name: Philip J. Mease, MD, MACR role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False
|
<|newrecord|> nctId: NCT06294223 id: SaglikBilU briefTitle: Upper Extremity and Muscle Oxygenation overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-03-01 date: 2024-03-05 date: 2024-03-18 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: The aim of this study was to measure the acute change in oxygen saturation of skeletal muscle during resistance exercise in the upper extremity using near-infrared spectroscopy. conditions: Near-infrared Spectroscopy conditions: Muscle Oxygenation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Exercise follow up with near-infrared spectroscopy measure: Determination of Blood Pressure measure: Saturation Measurement measure: Muscle Oxygenation Measurement measure: Determination of Heart Rate sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Saglik Bilimleri University status: RECRUITING city: Istanbul zip: 34010 country: Turkey name: Esra Pehlivan, Ass Prof role: CONTACT phone: 05058527913 email: esra.pehlivan@sbu.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False
|
<|newrecord|> nctId: NCT06294210 id: REC202307012 briefTitle: Supporting Secondary School Student Wellbeing Through a Mobile App and Wearable Biofeedback acronym: EWSSS overallStatus: NOT_YET_RECRUITING date: 2024-03-11 date: 2025-06-01 date: 2025-07-01 date: 2024-03-05 date: 2024-03-05 name: Royal College of Surgeons, Ireland class: OTHER briefSummary: This study aims to investigate the effects of an app and wearable device on the wellbeing of secondary school students. The app will offer support for stress management, sleep improvement, and time management. Additionally, it will provide access to educational resources, text-based coaching, and biofeedback monitoring through the wearable device. The device, worn around the wrist, will measure heart rate variability as an indicator of stress response. Throughout the study, students will complete bi-monthly surveys on sleep, stress, and overall wellbeing. To assess the specific impact of each feature, the app features will be released incrementally over the course of a year. The intervention group, comprising students in their last two years of secondary school, will have access to the app and wearable device, while a control group within the same class will not use the system but will complete the same wellness surveys. Coaches on this platform will come from the Centre for Positive Health Sciences MSc in Positive Health Coaching as part of their continued training in coaching. Coaching will be asynchronous so that students can post questions at any time during the day, but coaches will respond within 24 hours, during office hours. It will be made clear that this is not a therapeutic service and will be directed to other resources for these services. Coaches will file an incident report if a risk arises from a message with participants. Participants will be given guidelines for the type of questions they can ask such as asking for advice for setting goals related to their digital habits and sleeping better. The study\'s findings will provide valuable insights into the effectiveness of the app and wearable device in enhancing student wellbeing leading up to their leaving certification exams. conditions: No Disease or Condition is Being Studied conditions: Stress Psychological conditions: Overall Wellness studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A group of students will be using the mobile app and wrist-monitor to support their wellbeing while a control group of students will be followed at the same time who will not be using the app or wearable. The survey wellbeing, stress, and sleep scores will be compared between these groups. primaryPurpose: BASIC_SCIENCE masking: NONE count: 50 type: ESTIMATED name: Mobile app and wrist-worn monitor measure: Wellbeing Survey Results measure: Heart Rate Variability Metrics measure: Routine check-ins measure: App Engagement sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06294197 id: PhD Thesis briefTitle: Examination of the Effects of Pelvic Floor Exercises on Vaginal and Sexual Health in Postmenopausal Women. overallStatus: RECRUITING date: 2024-01-13 date: 2024-07-13 date: 2024-12-13 date: 2024-03-05 date: 2024-03-05 name: Hatice Gulsah Kurne class: OTHER briefSummary: The purpose of this study; To investigate the effects of pelvic floor muscle exercises on vaginal and sexual health in postmenopausal women. Vaginal symptoms such as vaginal dryness, burning and dyspareunia occur in the postmenopausal period. Vaginal symptoms affect sexual function, leading to a decrease in quality of life. In our study, we plan to evaluate vaginal dryness, one of the vaginal symptoms, using Schirmer's Test. Also in our study; Severities of vaginal dryness, burning and dyspareunia will be evaluated with the visual analog scale (VAS), sexual function will be evaluated with the Post-Menopausal Sexuality Questionnaire and Female Sexual Function Scale, vaginal aging will be evaluated with the Daily Effect of Vaginal Aging Scale, and the presence/severity of pelvic floor symptoms will be evaluated with the Pelvic Floor Distress Inventory-20. The cases will be randomized into two groups and pelvic floor exercises will be given to one group. After the exercises are given, vaginal pH and moistness will be evaluated for acute effect. In the other group, vaginal PH and moisture will be measured after 5 minutes. The cases will be followed without any intervention to the control group. After 12 weeks, the same evaluations will be made to both groups and the results will be compared. The data will be compared using appropriate statistical methods (statistical significance value will be taken as p\<0.05) and discussed with the literature. conditions: Sexual Dysfunction conditions: Postmenopausal Symptoms conditions: Pelvic Floor Muscle Weakness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment Randomized Healthy Participants primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Pelvic Floor Exercises measure: Schirmer's Test measure: Visual Analogue Scale (VAS) measure: Female Sexual Function Index (FSFI) measure: Postmenopausal Sexuality Questionnaire (PMSQ) measure: Vaginal Daily Impact of Aging Scale (VDIAS) measure: Disturbing Pelvic Floor Inventory-20 measure: Evaluation of Pelvic Floor Muscle Strength sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Training and Research Hospital status: RECRUITING city: Istanbul state: Fatih zip: 34098 country: Turkey name: Nebahat Uzunay, MD role: CONTACT phone: +905052609436 email: nebahatuzunay@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False
|
<|newrecord|> nctId: NCT06294184 id: Guangzhou PH tDCS in SD briefTitle: tDCS Interventions for Subthreshold Depressive Symptoms in Young Individuals. overallStatus: RECRUITING date: 2023-11-01 date: 2024-11 date: 2024-12 date: 2024-03-05 date: 2024-03-05 name: Guangzhou Psychiatric Hospital class: OTHER_GOV briefSummary: The purpose of this study is to assess the mechanisms of the effect of transcranial direct current stimulation (tDCS) in alleviating subthreshold depressive symptoms in young individuals, and individualized outcome prediction is carried out. conditions: Subthreshold Depression conditions: Young People conditions: Transcranial Direct Current Stimulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: tdcs lDLPFC name: tdcs rVLPFC name: Sham measure: The effect of tDCS in alleviating subthreshold depressive symptoms measure: Neuroaffective mechanisms of tDCS in alleviating subthreshold depressive symptoms measure: To predict the individual effect of tDCS in alleviating subthreshold depressive symptoms sex: ALL minimumAge: 12 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Guangzhou Brain hospital(Guangzhou Huiai Hospital) status: RECRUITING city: Guangzhou state: Guangdong zip: 510370 country: China name: Kangguang Lin, M.D;Ph.D role: CONTACT phone: 86-13560360144 email: klin@gzhmu.edu.cn lat: 23.11667 lon: 113.25 hasResults: False
|
<|newrecord|> nctId: NCT06294171 id: Modified Alveolar Bone Cut briefTitle: Efficacy of Modified Piezosurgery Alveolar Bone Cut With Osseodensification Drills in Expanding Narrow Alveolar Bone overallStatus: COMPLETED date: 2022-11-15 date: 2023-05-01 date: 2023-11-01 date: 2024-03-05 date: 2024-03-05 name: University of Baghdad class: OTHER briefSummary: The aim of the study is to determine the efficacy of modified piezosurgery with osseodensification drills in expanding narrow alveolar bone. conditions: Dental Implant Failed studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 14 type: ACTUAL name: measurement of alveolar ridge width measure: expansion rate measure: expansion rate sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: University of Baghdad College of Dentistry city: Baghdad zip: 10011 country: Iraq lat: 33.34058 lon: 44.40088 hasResults: False
|
<|newrecord|> nctId: NCT06294158 id: LANYARD-ICU-1.1 briefTitle: Light and Noise: Objectively Assessing Environmental Risk Factors for Delirium in the ICU acronym: LANYARD-ICU overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-07 date: 2025-11 date: 2024-03-05 date: 2024-03-05 name: Medical University of Graz class: OTHER briefSummary: Recognition of delirium as a medical entity with relevance to both morbidity and mortality, especially in critically ill patients, is a relatively recent development. However, research into delirium prevention and treatment is now in focus of scientific efforts internationally.
|
Knowledge of intensive care unit (ICU) environment as a potential modifiable risk factor for delirium is insufficient to this date. This study thus seeks to evaluate, whether potentially modifiable environmental factors, such as noise or dazzling, are associated with development of delirium. Knowledge derived from this investigation could change both the process of care provision in intensive care units as well as the design of ICUs in general in the future.
|
This project is planned to be carried out as an observational pilot study at three perioperative ICUs at the University Medical Centre Graz. Adult patients shall be screened for inclusion, if not deeply sedated. Suitable patients shall be included into the study after written informed consent or deferred consent if they can be expected to remain in the ICU for at least another two days, if they are not already in delirium, if the ICU environment is not actively modified for therapeutic reasons and if no treatment limitations are in place. Over a study duration of one year, 250 to 300 patients are expected to be enrolled into the study. Of those, 60 to 120 patients are likely to develop delirium.
|
Baseline data known to be of relevance for outcome prediction in critically ill patients and factors known to predispose for development of delirium during ICU and hospital stay will be collected. Study equipment will be deployed to measure noise levels and illumination repeatedly over the day. Daily assessments for delirium using the Confusion Assessment Method in Intensive Care Units (CAM-ICU) will be performed. Vital status, physiologic parameters and parameters of ongoing treatment will concomitantly be documented on a daily basis.
|
Data on light and noise levels are then to be unified with parameters of physiology and treatment, vital status, and results of daily assessments for delirium. Statistical analysis using methods of descriptive and comparative statistics as well as both unadjusted and adjusted logistic regression analysis will be performed to identify factors significantly associated with the development of delirium (i.e., risk factors). conditions: Delirium conditions: Critical Illness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Brightness measurement name: Sound level measurement measure: Delirium sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Centre Graz, Dept. of Anaesthesiology and Intensive Care Medicine city: Graz state: Styria zip: 8036 country: Austria name: Andrea Berghofer, Mag role: CONTACT phone: +43 316 385 0 phoneExt: 84663 email: anaesthesie-allgemein@medunigraz.at name: Paul Zajic, MD PhD role: PRINCIPAL_INVESTIGATOR name: Philipp G. H. Metnitz, MD PhD role: SUB_INVESTIGATOR name: Andreas Münch, MD role: SUB_INVESTIGATOR name: Andreas Waltensdorfer, MD role: SUB_INVESTIGATOR name: Gabriel Honnef, MD PhD role: SUB_INVESTIGATOR name: Christian Regvar, MD role: SUB_INVESTIGATOR name: Barbara Hallmann, MD role: SUB_INVESTIGATOR name: Martin Rief, MD PhD role: SUB_INVESTIGATOR name: Alexander Pichler, MD role: SUB_INVESTIGATOR name: Michael Eichlseder, MD role: SUB_INVESTIGATOR lat: 47.06667 lon: 15.45 hasResults: False
|
<|newrecord|> nctId: NCT06294145 id: U24AG072699 type: NIH link: https://reporter.nih.gov/quickSearch/U24AG072699 briefTitle: Effects of a Wellbeing Intervention on Inflammation Through Reward and Threat Processes acronym: SAVOR overallStatus: RECRUITING date: 2024-02-07 date: 2025-01-31 date: 2025-01-31 date: 2024-03-05 date: 2024-03-05 name: University of California, Los Angeles class: OTHER name: Network for Emotional Wellbeing name: National Institutes of Health (NIH) briefSummary: This study aims to evaluate how savoring influences reward and threat processes and downstream inflammation. Savoring is designed to enhance positive affect, which may blunt stress responses and reduce downstream inflammation. The investigators aim to examine changes in the brain following the savoring intervention. The investigators are particularly interested in changes in brain activity that are correlated with changes in inflammation-related markers in the blood. In this single-armed pilot trial, the investigators will assess how savoring alters reactivity to rewarding and threatening experiences, and then examine related changes in downstream inflammation. The investigators intend to recruit 20 undergraduate students to complete a 7-week standardized savoring intervention. Participants will complete brain scans, daily diaries, questionnaires, a behavioral task, and blood collection at pre- and post-intervention assessments. conditions: Low Positive Affect studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All 20 participants will be assigned to the same 7-week savoring intervention. primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ESTIMATED name: Savoring Intervention measure: Positive affect measure: Negative affect measure: Depression measure: Anxiety measure: Perceived stress measure: Psychological wellbeing measure: Emotions measure: Reward measure: Savoring strategies measure: Interoception measure: Inflammation measure: Sustained Attention measure: Neural Reward Activity measure: Neural Threat Activity measure: Daily diary sex: ALL minimumAge: 18 Years maximumAge: 22 Years stdAges: ADULT facility: University of California, Los Angeles status: RECRUITING city: Los Angeles state: California zip: 90095 country: United States name: Robin B Blades role: CONTACT phone: 510-520-5780 email: robinblades@gmail.com name: Julienne Bower, PhD role: CONTACT phone: 310-825-3004 email: jbower@g.ucla.edu name: Julienne Bower, PhD role: PRINCIPAL_INVESTIGATOR name: Chloe Boyle, PhD role: SUB_INVESTIGATOR name: Naomi Eisenberger, PhD role: SUB_INVESTIGATOR name: Steve Cole, PhD role: SUB_INVESTIGATOR name: Michelle Craske, PhD role: SUB_INVESTIGATOR name: Aileen Echiverri, PhD role: SUB_INVESTIGATOR name: Robin Blades role: SUB_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False
|
<|newrecord|> nctId: NCT06294132 id: 4016601 briefTitle: Effect of Lumbar Manipulation on Intervertebral Motion, Pain, and Disability overallStatus: RECRUITING date: 2024-02-27 date: 2024-10-21 date: 2024-10-28 date: 2024-03-05 date: 2024-03-08 name: Ithaca College class: OTHER briefSummary: Background / Purpose:
|
There is an ongoing debate regarding the ability of physical therapists to manually sense intervertebral motion. Physical therapists use intervertebral hypomobility as a clinical indicator for spinal manipulation. Also in question is the mechanism of improvement observed after spinal manipulation. Some argue that the improvement is purely neurophysiologic and unrelated to changes in intervertebral motion. This study aimed to determine the diagnostic accuracy of a physical therapist's manual assessment of lumbar intervertebral motion compared to ultrasound imaging and the effect of lumbar manipulation on intervertebral motion, pain, and disability,
|
Methods:
|
Subjects will complete a Numeric Pain Rating Scale (NPR),Oswestry Disability Index (ODI), and a Central Sensitization Inventory before arriving for the study via Qualtrics survey tool. They will be screened for contraindications to manipulation and neurological signs and symptoms. Active forward bending will be quantified by measuring the distance of the subject's fingertips to the floor. Two experienced physical therapists will evaluate the subject's lumbar intervertebral mobility. They will identify the lumbar segment with the least motion or hypomobility. The subjects will be imaged from L1 to S1 with a 5 MHz curvilinear transducer (Edge II MSK ultrasound unit, SonoSite, Inc, Bothell, WA) in the sidlying position with their trunk and hips flexed to end-range. The examiner will save the sagittal image and then place a digital caliper to measure the distance between the spinous processes from the peak of the hyperechoic curvature of the caudal spinous process to the peak of the hyperechoic curvature of the cranial spinous process of each lumbar segment (L5-S1, L4-L5, L3-L2,L2-L1). Subjects will then be randomized to receive a high-velocity low amplitude thrust manipulation or a sham manipulation. The lumbar spine will be reimaged. The ultrasound examiner will be blinded to the manipulation and the caliper measurements. Finally, subjects will be asked for their Global Rating of Change (GROC) and to actively bend forward to remeasure the distance of their fingertips to the floor. One week later, patients will receive an e-mail containing links to repeat the NPR, GROC, and ODI. conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to either receive lumbar manipulation or a sham lumbar manipulation. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Participant: the participants will not know whether they received the lumbar manipulation or sham lumbar manipulation.
|
Care Provider: the care providers (those who perform the lumbar manipulation and sham lumbar manipulation) will not be involved in collecting any outcome data.
|
Investigator: all investigators collecting outcome measures will not know which subjects received the lumbar manipulation or sham lumbar manipulation.
|
Outcome assessor: the outcome assessors will not be involved in collecting data. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Lumbar Manipulation name: Sham Lumbar Manipulation measure: Diagnostic Ultrasound measure: Trunk Flexion Range Of Motion Measurement measure: Oswestry Disability Questionnaire measure: Numeric Pain Rating Scale measure: Global Rating of Change sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Ithaca College status: RECRUITING city: Ithaca state: New York zip: 14850 country: United States name: John Winslow role: CONTACT phone: 607-229-8792 email: jwinslow@ithaca.edu name: Michael Costello role: CONTACT email: mcostello@ithaca.edu lat: 42.44063 lon: -76.49661 hasResults: False
|
<|newrecord|> nctId: NCT06294119 id: MANCAVA id: 2022SLB5MX type: OTHER_GRANT domain: Italian Ministry of Research briefTitle: Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay overallStatus: RECRUITING date: 2024-02-08 date: 2026-02-08 date: 2026-02-08 date: 2024-03-05 date: 2024-03-05 name: IRCCS Policlinico S. Donato class: OTHER briefSummary: MANCAVA sets out fundamental methodologies for characterizing human fundamental physiological system interactions at a whole-body level, particularly focusing on the interplay among cortical brain activity, autonomic function, and cerebrovascular autoregulatory mechanisms. By investigating the complex, time-varying mechanisms underlying the multisystem dynamic interactions, novel methods linking various brain areas and reflex functions to target organs and districts such as heart and circulatory system are proposed with the clinical aim linked to the emerging topic of depression.
|
In this scenario, proper new mathematical tools will allow a significant leap from the current state of the art, paving the way towards a new understanding of leading comorbid contributors to global diseases such as cardiac and cerebrovascular morbidity in mood disorders. In turn, this will provide an integration among physiological and psychological dimensions for a more holistic view on depression.
|
Researchers, professionals, and patients will all benefit from a comprehensive assessment of brain-mind-body interplay, leading to the new extended definition of default mode/mood network, neurovascular-evoked responses to autonomic stimuli, brain-autonomic consequences of emotional responses, and physiological substrates of depressive states. conditions: Cardiac Disease conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 80 type: ESTIMATED name: Major Cardiac surgery measure: Autoregulation index (ARI) measure: number of patients developing depression measure: Baroreflex sensitivity measure: Cortical activity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Policlinico San Donato status: RECRUITING city: San Donato Milanese state: Milan zip: 20097 country: Italy name: Vlasta Bari, PhD role: CONTACT phone: +390252774381 email: vlasta.bari@grupposandonato.it name: Pavandeep Singh role: CONTACT email: pavandeep.singh@grupposandonato.it name: Marco Ranucci, MD role: PRINCIPAL_INVESTIGATOR name: Vlasta Bari, PhD role: SUB_INVESTIGATOR name: Alberto Porta, PhD role: SUB_INVESTIGATOR name: Francesca Gelpi, Ms role: SUB_INVESTIGATOR name: Beatrice Cairo, PhD role: SUB_INVESTIGATOR lat: 45.41047 lon: 9.26838 hasResults: False
|
<|newrecord|> nctId: NCT06294106 id: 24-212 briefTitle: eTMS for Veterans and First Responders With PTSD overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-03-05 date: 2024-03-05 name: Virginia Polytechnic Institute and State University class: OTHER name: Wave Neuroscience briefSummary: A battery of physiological and behavioral data will be collected before and after application of eTMS. Participants will be veterans or first responders diagnosed with PTSD. Study will be a double-blind, sham-controlled, parallel group, randomized clinical trial. conditions: Post Traumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 10 participants will receive eTMS treatment 10 participants will receive sham eTMS treatment primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: eTMS coil will have an 'active' and 'sham' side and the application will look identical to the participant. The technician will not know which side of the coil is which and will additionally be blinded. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS) measure: Adverse Events measure: Report of Symptoms measure: PCL-5 sex: ALL minimumAge: 22 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fralin Biomedical Research Institute city: Roanoke state: Virginia zip: 24016 country: United States name: Jessica Florig, MPH role: CONTACT phone: 540-526-2261 email: jnw@vtc.vt.edu name: Wynn Legon, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.27097 lon: -79.94143 hasResults: False
|
<|newrecord|> nctId: NCT06294093 id: 026/24 briefTitle: Differences Between Long Distance Road Runners and Treadmill Runners in Achilles Tendon Structure overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-02-15 date: 2025-02-15 date: 2024-03-05 date: 2024-03-07 name: University of Haifa class: OTHER name: Zinman College of Physical Education and Sports Sciences briefSummary: this study will investigate the structure of the Achilles tendon and functional tests in road runners compared to treadmill runners. conditions: Achilles Tendon Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED measure: ultrasound tissue characterized measure: Balance test measure: Proprioception test measure: muscle strength test measure: endurance test gastrocnemius muscle sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
|
<|newrecord|> nctId: NCT06294080 id: DfH2023 briefTitle: Effects of Dance and Tai Chi on Balance and Wellbeing on Healthy Adults overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2024-11 date: 2025-01 date: 2024-03-05 date: 2024-03-05 name: University of Wolverhampton class: OTHER briefSummary: The aim of the proposed randomised controlled study is to compare the effects and efficacy between a dance, a Tai Chi and a waiting list control group intervention over an eight-week period on physical functions and mental benefits among non-clinical adults aged between 18 and 59. The study's primary outcome is mental wellbeing and secondary parameters are physical functional and mood. A tertiary outcome will examine how the physical and mental parameters change during the learning and practice phases conditions: General Population studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Random Controlled Trial: Blind primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Data collection carried out by RAs blinded to participants' group allocation Statistician blinded to the group and test parameters whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Dance name: Tai Chi measure: Well-being measure: Leg strength measure: Balance measure: Mood sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: University of Wolverhampton city: Walsall state: West Midlands zip: WS1 3BD country: United Kingdom lat: 52.58528 lon: -1.98396 hasResults: False
|
<|newrecord|> nctId: NCT06294067 id: 43261 briefTitle: A Dose Response Investigation of Docosahexaenoic Acid (DHA) acronym: DRI-DHA overallStatus: RECRUITING date: 2024-03 date: 2025-04 date: 2025-09 date: 2024-03-05 date: 2024-03-27 name: University of Toronto class: OTHER name: Unity Health Toronto briefSummary: Docosahexaenoic acid (DHA) is an omega-3 polyunsaturated fatty acid (n-3 PUFA), commonly consumed from fish, that regulates many critical functions within the body including the brain, eye, and heart. While the metabolic precursor to DHA, alpha-linolenic acid (ALA) is considered nutritionally essential and has a set Dietary Reference Intake (DRI), DHA has not yet been deemed essential and does not have a set DRI. Currently, research suggests an intake range of dietary DHA to be anywhere from 0 to over 500mg/d. The aim of our study is to further investigate a feedback mechanism or accumulation that occurs with eicosapentaenoic acid (EPA) as a result of increased dietary DHA to provide insight for potential Recommended Dietary Intake (RDI) values.
|
Hypothesis: The dietary DHA dose at which blood EPA levels increase is the point at which elongation slows, indicating a significant negative feedback pathway is present.
|
Objectives: 1: To determine the dose-response for DHA to increase blood EPA levels in a mixed vegetarian and vegan population. 2: Investigate the DHA dose and time at dose that increases EPA using natural abundance delta carbon-13 (δ13C) as a tracer. 3: To measure DHA turnover and loss rates. 4: Provide data for exploratory analyses related to PUFA metabolism and the effect of DHA on disease related biomarkers.
|
Method: During an 8-week trial, 72 healthy vegan or vegetarian males and females (18-50 years) will be supplemented with 1 of 6 algal-oil based DHA doses: 0, 100, 200, 400, 800 or 1000 mg/d. Blood will be collected at days 0, 3, 7, 14, 28 and 56 and will be analyzed for changes in blood EPA levels as the primary outcome and plasma δ13C EPA signature as the secondary outcome.
|
Significance: Investigating this negative feedback pathway is of great importance in providing evidence to support n-3 PUFA DRIs. EPA and DHA are ecologically sensitive with their major source coming from unsustainably farmed fish stocks and having a set DRI may help to limit the overconsumption of these nutrients. conditions: Nutrition, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double blinded, randomized, control, dose-response supplementation trial primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: For randomization we will use the Research Electronic Data Capture (REDCap) program. Following successful completion of informed consent, the questionnaire and anthropometric assessment participants will be randomized into groups, of a possible six, using a blocked (Latin squares) randomization. These groups will represent DHA0 (0mg/d), DHA1 (100mg/d), DHA2 (200mg/d), DHA3 (400mg/d), DHA4 (800mg/d), and DHA5 (1000mg/d) groups. The Latin square sequences will be randomly allocated to participants with a similar number of participants allocated to each treatment sequence. The participants will only be randomized once all information is collected, informed consent has been obtained and questionnaires have been filled out following the first study call/zoom meeting. Then following their first study in person visit and post blood sample extraction they will be given their DHA capsules, which have been organized by a lab member not directly involved in the study. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 72 type: ESTIMATED name: docosahexaenoic acid (DHA) name: soybean oil placebo measure: Changes in omega-3 polyunsaturated fatty acid (n-3 PUFA) blood levels measure: Changes in the delta carbon 13 (δ13C) n-3 PUFA signatures measure: Measure of n-3 LC PUFA turnover rates measure: Measure of n-3 LC PUFA half-lives measure: Increased intake of dietary α-Linolenic acid (ALA) and the inhibition of long chained omega-3 polyunsaturated fatty acids (LC n-3 PUFA) synthesis measure: Comparing the potential change in omega-3 long chained polyunsaturated fatty acids (n-3 LC PUFA) levels between male and female participants measure: Comparing the potential change in n-3 LC PUFA δ13C signatures between male and female participants measure: Comparing the potential change in n-3 LC PUFA levels between genetic variations measure: Comparing the potential change in n-3 LC PUFA δ13C signatures between genetic variations measure: Changes in cardiovascular disease (CVD) biomarkers (BMI in kg/m^2) measure: Changes in cardiovascular disease (CVD) biomarkers (Waist circumference in cm/inch) measure: Changes in cardiovascular disease (CVD) biomarkers (blood pressure in mmHg) measure: Changes in cardiovascular disease (CVD) biomarkers (heart rate in beats per minute) measure: Changes in cardiovascular disease (CVD) biomarkers (blood lipid profile changes in mmol/L) measure: Changes in δ13C DHA signature levels to document adherence sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Clinical Nutrition and Risk Factor Modification Centre status: RECRUITING city: Toronto state: Ontario zip: M5C 2T2 country: Canada name: Amy Symington, PhD student role: CONTACT email: dhatrial@unityhealth.to name: John Sievenpiper, MD, PhD, FRCPC role: CONTACT email: john.sievenpiper@alumni.utoronto.ca name: Richard Bazinet, PhD role: SUB_INVESTIGATOR name: John Sievenpiper, MD, PhD, FRCPC role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
|
<|newrecord|> nctId: NCT06294054 id: 2021/0393/HP briefTitle: Bladder Cancer and Neoadjuvant Chemotherapy Efficiency Before Cystectomy acronym: SELECT overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-01 date: 2026-03-31 date: 2026-03-31 date: 2024-03-05 date: 2024-03-06 name: University Hospital, Rouen class: OTHER name: Institut Curie briefSummary: This study will allow the investigators to better assess the efficiency of neoadjuvant chemotherapy before cystectomy by training a predictive model on different patient cohorts with bladder cancer. conditions: Bladder Cancer conditions: Genomic Instability studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 707 type: ESTIMATED name: neoadjuvant chemotherapy with cisplatine measure: Progression-free survival measure: Overall survival sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre de lutte contre le cancer François Baclesse city: Caen country: France lat: 49.18585 lon: -0.35912 facility: Centre de recherche des Cordeliers city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Saint-Louis AP-HP city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Institut Curie Centre de Recherche city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Institut Curie city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Institut Gustave Roussy city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Mines ParisTech city: Paris country: France lat: 48.85341 lon: 2.3488 hasResults: False
|
<|newrecord|> nctId: NCT06294041 id: UEC23/52 briefTitle: INvestigating the Value of Early Sleep Therapy acronym: INVEST overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-06-01 date: 2025-06-01 date: 2024-03-05 date: 2024-03-05 name: University of Strathclyde class: OTHER name: University of Oxford name: University of Glasgow name: NHS Greater Glasgow and Clyde name: NHS Grampian briefSummary: Twenty percent of breast cancer survivors have insomnia, which is defined as persistent trouble falling and/or staying asleep that results in difficulty functioning during the day. Sleep difficulties often begin at cancer diagnosis, become worse during cancer treatment, and continue into cancer survivorship. Insomnia interferes with daily activities and may cause other mental and physical health problems. It also makes it more difficult to cope with cancer treatment and makes recovery more challenging. For these reasons, it is important to address early signs of sleep problems in cancer patients by offering interventions that may prevent the development of insomnia.
|
Sleep Restriction Therapy is one such intervention, which helps improve night-time sleep by stabilising sleep patterns and reducing time spent in bed awake. Sleep Restriction Therapy has been used successfully to treat chronic insomnia in breast cancer survivors who have completed cancer treatment. However, it has never been tested on newly diagnosed breast cancer patients with early signs of sleep disturbance, who are undergoing cancer treatment.
|
This study will address this knowledge gap by randomly assigning newly diagnosed patients with poor sleep to receive either Sleep Restriction Therapy or a sleep hygiene education (SHE) control intervention. The study will assess sleep and mental health before and after both interventions to determine how feasible and acceptable Sleep Restriction Therapy is to patients and to plan for a future, larger study. Throughout, the investigators will work with patients with lived experience of breast cancer and poor sleep to ensure our study is informed by their expertise. conditions: Acute Insomnia (Disorder) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE maskingDescription: Due to the nature of the SRT intervention, the research nurse, patients and most of the study team cannot be blinded to treatment allocation. However, the statistician will be blinded to treatment allocation (i.e., SRT or SHE) until after analysis is complete whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Sleep Restriction Therapy (SRT) name: Sleep Hygiene Education (SHE) measure: Recruitment rates measure: Retention rates measure: Intervention fidelity: Therapist adherence measure: Intervention fidelity: Patient engagement measure: Intervention fidelity: Control group contamination measure: Outcome measure completion measure: Intervention acceptability measure: Improvement in insomnia severity measure: Improvement in mental health [depression] measure: Improvement in mental health [anxiety] measure: Improvement in rest-activity rhythms [fatigue]Fatigue (FACT-F) measure: Improvement in rest-activity rhythms measure: Improvement in sleep [estimates of subjective sleep] measure: Measure of health related quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06294028 id: RC31/21/0338 briefTitle: International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease With Minimally Impaired Ejection Fraction acronym: VIVA overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2029-12-31 date: 2029-12-31 date: 2024-03-05 date: 2024-03-05 name: University Hospital, Toulouse class: OTHER briefSummary: Evidence for the usefulness of the defibrillator in cases of preserved left ventricular ejection fraction and well-tolerated ventricular tachycardia (without cardiocirculatory arrest or syncope) is lacking, as no previous trials have included such patients. Additionally, sudden death in this particular population is low compared to other subgroups of patients with malignant ventricular arrhythmias.
|
On the other hand, numerous recent retrospective data show that ablation of ventricular tachycardia can reduce mortality, and also clearly reduces the number of recurrences in prospective studies.
|
Finally, a very low rate of sudden death was observed in a multicenter European retrospective study that we conducted, including patients with well-tolerated ventricular tachycardia in structural heart disease with minimally impaired ejection fraction and benefiting from ablation without implantation of defibrillator. conditions: Ischemic Heart Disease conditions: Ventricular Tachycardia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 268 type: ESTIMATED name: Adverse events collection name: Quality of life questionnaire EQ-5D-5L name: Medical-economic evaluation measure: Monitoring for the occurrence of at least one serious event during the 36 months of follow-up sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06294015 id: 2023-5009 briefTitle: Efficacy of 20% Autologous Serum Drops in the Treatment of Corneal Epitheliopathy Associated With Antihypertensive Glaucoma Drops. overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2026-04 date: 2024-03-05 date: 2024-03-05 name: Université de Sherbrooke class: OTHER briefSummary: Introduction: Glaucoma is the second leading cause of blindness globally. Most anti-hypertensive drops contain preservatives harmful to the corneal epithelium, with up to 78% of treated patients reporting dry eye symptoms. Autologous serum eye drops (ASED), contains essential growth factors and nutrients which may promote corneal and conjunctival integrity, offering benefits over traditional treatments. This study investigates the efficacy of 20% ASED over placebo in the treatment of corneal epitheliopathies in patients with glaucoma treated with antihypertensive drops.
|
Methods: The present study is a triple-blinded, randomized controlled trial that anticipates to enroll 25 patients (50 eyes) with bilateral corneal epitheliopathy secondary to antihypertensive glaucoma treatments. Patients will receive autologous serum eye drops in one eye and placebo in the contralateral eye for two months, in addition to standard artificial tears treatment.
|
The primary outcome is the comparison of National Eye Institute (NEI) scores between autologous serum drops and placebo-treated eyes at two months. Secondary outcomes include Schirmer's test scores, visual acuity, tear break-up time (TBUT), Ocular Surface Disease Index (OSDI) scores, intraocular pressure, and complication rates.
|
The study aims to analyze the effectiveness of autologous serum eye drops in treating corneal epitheliopathies in glaucoma patients, potentially offering a new therapeutic avenue. conditions: Corneal Epitheliopathy conditions: Glaucoma conditions: Corneal Disease conditions: Dry Eye studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 25 type: ESTIMATED name: 20% ASED + AT name: 0.9% NS + AT measure: National Eye Index Scores measure: Schirmer Test measure: Visual Acuity measure: Tear Break Up Time measure: Ocular Surface Disease Index measure: Intraocular Pressure measure: Complication rates sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06294002 id: 46-06-04/2020-1 briefTitle: Neuromuscular Training & Postural Stability acronym: STABLEFIT overallStatus: COMPLETED date: 2022-02-15 date: 2022-02-20 date: 2022-06-25 date: 2024-03-05 date: 2024-03-06 name: University of Novi Sad class: OTHER briefSummary: Background: Postural stability (PS) is a vital function that helps maintain equilibrium during standing still, locomotion, and any activities requiring high balance performance. Under static and dynamic conditions, PS is a fundamental factor for the quality of movement in everyday activities or sports. PS and adaptive ability are required in sports due to the interactions between the sensory and motor systems, which regulate postural adjustments by processing information from the visual, vestibular, and somatosensory systems, as reported by previous studies. The interest in using different exercises and protocols for improving PS in sports and physiotherapy has grown in the last few decades. Experts have proposed various training modalities to increase neuromuscular stability, balance, postural control, and general stability. Dynamic Neuromuscular Stabilization (DNS) is a complex of correction exercises with a neuromuscular approach based on improving breathing, fundamental movements, and principles of developmental kinesiology. Whole body vibration training (WBV) is a neuromuscular training approach that has recently become very popular among researchers and practitioners in health and sport. It is usually used as an additional method in a conventional training routine. Designing the training program to achieve the optimal benefits for PS in healthy young adults is important in general personal health management. Although different training protocols have improved PS and general stability in everyday activities, there is still considerable debate regarding the optimal exercise modalities within an exercise program. Aim: The purpose of this study is to determine the effects of dynamic neuromuscular stabilisation (DNS), whole-body vibration (WBV), and a combination of DNS and WBV (MIX) training modalities on postural stability (PS) in healthy recreation participants. Method and materials: 180 gender-balanced groups were divided into four groups, MIX, DNS, VIBRO and CONTROL and underwent two months of treatment. The single and double-leg Center of Force (COF) parameters were collected on the Forceplate. conditions: Postural Stability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 180 type: ACTUAL name: Dynamic neuromuscular stabilisation group name: Whole body vibration group name: Dynamic neuromuscular stabilisation with whole body vibration group measure: Double-leg static postural stability sway area measure: Double-leg static postural stability center of force traveled way measure: Double-leg static postural stability medio-lateral displacement measure: Double-leg static postural stability anterior-posterior displacement measure: Single-leg static postural stability sway area measure: Single-leg static postural stability center of force traveled way measure: Single-leg static postural stability anterior-posterior displacement measure: Single-leg static postural stability medio-lateral displacement measure: Sex measure: Date of birth measure: Weight measure: Height measure: Body Mass Index (BMI) measure: Adherence sex: ALL minimumAge: 21 Years maximumAge: 26 Years stdAges: ADULT facility: Faculty of sport and Physical Education, University of Novi Sad city: Novi Sad state: Vojvodina zip: 21000 country: Serbia lat: 45.25167 lon: 19.83694 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-02-19 uploadDate: 2024-02-27T09:25 filename: Prot_000.pdf size: 468513 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-19 uploadDate: 2024-02-27T09:26 filename: ICF_001.pdf size: 167182 hasResults: False
|
<|newrecord|> nctId: NCT06293989 id: Emergency department briefTitle: Efficacy and Safety of Intravenous Diazepam Given at 2 Different Doses Compared to Placebo in Acute Peripheral Vertigo acronym: Vertigo overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-30 date: 2026-03-30 date: 2024-03-05 date: 2024-04-02 name: University of Monastir class: OTHER briefSummary: This is prospective, randomised double-blind study that will be conducted in the emergency department of 3 university hospitals (FB Monastir, Sahloul Sousse, and FH Sousse) to compare the efficacy of two doses of diazepam (Valium®) and placebo for the relief of acute periphery vertigo in the ED conditions: Vertigo, Peripheral studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 1000 type: ESTIMATED name: Diazepam 5mg name: Diazepam 10 mg name: Placebo measure: Visual analogue scale (VAS)-3H measure: the Delta-VAS measure: the time required to reach the resolution of the vertigo crisis measure: Patients satisfaction measure: number of patients with adverse effects sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06293976 id: 4506 briefTitle: Susceptibility for Entrainment: Role of Ventilator Settings on the Occurrence of Reverse Triggering and Its Physiological Consequences - the SEVeRe Study acronym: SEVERE overallStatus: RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2026-03-01 date: 2024-03-05 date: 2024-03-05 name: Unity Health Toronto class: OTHER briefSummary: Background: Reverse triggering (RT) is a frequent phenomenon observed in sedated patients under a mechanical ventilation mode called assist-control ventilation. RT is when the ventilator would trigger the patient's respiratory effort instead of the correct order of the patient's respiratory effort triggering the ventilator. Reverse triggering can have negative consequences (loss of protective lung ventilation, and causing double breaths - with the ventilator giving two consecutive breaths and not allowing the patient to exhale) but also offer some protective effects (avoid diaphragm disuse atrophy). The balance of its negative vs positive effects depends on its frequency and magnitude of its associated respiratory effort. Respiratory entrainment is the most often referred mechanism involving a change in patient's rate of breathing effort from that of patient's intrinsic rate to the rate of mechanical insufflation. The specific ventilatory settings associated with or responsible for RT remains unknown.
|
Aims: To assess in mechanically ventilated critically ill patients the influence of the set respiratory rate (RR) and tidal volume (Vt) on the presence/development of RT and to describe the pattern of respiratory muscle activity during Reverse Triggering (RT).
|
Methods. 30 adult patients (15 in each group), sedated and under assist-controlled ventilation will be included. Ventilator settings will be modified to modulate the frequency and magnitude of reverse triggering. Initially, with the ventilator on a mode called volume control, which means the ventilator controls the amount of air (tidal volume) and the number of breaths the patients gets every minute (respiratory rate \[RR\]). The tidal volume will be set at the current standard clinical practice setting (6 ml/kg of predicted body weight). The presence of an intrinsic respiratory rate will be assessed with an end-expiratory occlusion maneuver. Next, the number of breaths the ventilator gives per minute (RR) will be changed from 6 breaths less to 6 breaths more, in steps of 2 breaths every minute. The protocol will be repeated again changing the amount of air the patients gets (tidal volume) from 4, 5, 7 and 8 ml/kg. Continuous recordings of airway pressure, flow, esophageal pressure, electrical activity of the diaphragm, main accessory muscles and frontal electroencephalography will be obtained during the protocol and baseline clinical and physiological characteristics and outcomes will be recorded. A validated software will be used to detect RT and measure the intensity and timing of each muscle electrical activity and the magnitude of the inspiratory effort during RT. conditions: Respiration, Artificial conditions: Reverse Triggering studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Changes in the ventilator respiratory rate and tidal volume measure: The rate of of reverse triggered breaths occurring after each change in the ventilator respiratory rate and tidal volume. measure: The magnitude of the effort, measured by the drop in the esophageal pressure in cmH2O, associated with the reverse triggered breaths after each change in the ventilator respiratory rate and tidal volume sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Unity Health Toronto - St. Michael's Hospital status: RECRUITING city: Toronto state: Ontario zip: M5B 1T8 country: Canada name: Audery Kim role: CONTACT phone: 416-864-5686 email: audery.kim@unityhealth.to name: Antenor Rodrigues role: SUB_INVESTIGATOR name: Laurent Brochard role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
|
<|newrecord|> nctId: NCT06293963 id: 24-0300a briefTitle: Front-of-package Label Effects in Latine and Limited English Proficiency Populations overallStatus: NOT_YET_RECRUITING date: 2024-03-29 date: 2024-04-15 date: 2024-04-15 date: 2024-03-05 date: 2024-03-18 name: University of North Carolina, Chapel Hill class: OTHER name: Duke University name: Stanford University briefSummary: The goal of this experiment is to examine the effects of 4 types of front-of-package food labels among a sample of Latino adults. The main questions this experiment aims to answer are:
|
What front-of-package label design is most effective in helping Latino and low English proficiency consumers identify healthier and less healthy food products?
|
What front-of-package label design is most effective in helping Latino and low English proficiency consumers choose healthier food products?
|
Additionally, this experiment also aims to answer the following question:
|
Do the benefits of front-of-package label designs differ by English proficiency and parental status?
|
Participants will be randomly assigned to 1 of 4 types of front-of-package label designs and view their assigned label design on 3 sets of products. Each set will display 3 similar products, each high in either 1, 2, or 3 nutrients of concern. For each set, participants will select the product that they believe to be the healthiest, least healthy, and the product that they would most want to consume. Researchers will compare results across label designs. conditions: Diet, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 4000 type: ESTIMATED name: Guideline Daily Amounts label name: Interpretive text-only label name: Interpretive magnifying glass icon label name: Separated interpretive magnifying glass icon label measure: Selection of healthiest product for purchase measure: Correct identification of healthiest product measure: Correct identification of least healthy product measure: Correct identification of products high in nutrients sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: The University of North Carolina at Chapel Hill's Gillings School of Global Public Health city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Marissa G Hall, PhD role: CONTACT phone: 919-445-1310 email: mghall@unc.edu lat: 35.9132 lon: -79.05584 hasResults: False
|
<|newrecord|> nctId: NCT06293950 id: AUTISM briefTitle: Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism overallStatus: RECRUITING date: 2022-03-09 date: 2024-06 date: 2024-12 date: 2024-03-05 date: 2024-03-05 name: University of Jordan class: OTHER briefSummary: Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities. conditions: Autism studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 14 type: ESTIMATED name: WJMSC measure: safety profile lab tests measure: efficacy change in Adult ADHD Self-Report Scale (ASRS) sex: ALL minimumAge: 4 Years maximumAge: 14 Years stdAges: CHILD facility: Cell Therapy Center status: RECRUITING city: Amman zip: 00962 country: Jordan name: Hanan Jafar, PhD role: CONTACT phone: 00962798871087 email: hanan.jafar@gmail.com name: Abdallah Awidi, MD role: CONTACT phone: 0096265355000 phoneExt: 23960 email: abdalla.awidi@gmail.com lat: 31.95522 lon: 35.94503 hasResults: False
|
<|newrecord|> nctId: NCT06293937 id: 24-0300b briefTitle: Impact of Front-of-package Labels on Weight Bias Among Latines overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-04-30 date: 2024-04-30 date: 2024-03-05 date: 2024-04-03 name: University of North Carolina, Chapel Hill class: OTHER name: Duke University name: Stanford University briefSummary: The goal of this experiment is to examine the effects on explicit weight bias of a selection task using 4 different types of front-of-package food labels to select healthy or unhealthy foods among a sample of Latine and low English proficiency adults. The main questions this experiment aims to answer are:
|
* Does the use of different front-of-package label designs in a selection task lead to different effects on explicit weight bias among Latine and low English proficiency consumers?
|
* Does the use of different front-of-package label designs in a selection task lead to different effects on attribution of personal responsibility for body weight among Latine and low English proficiency consumers?
|
Participants will be randomly assigned to 1 of 4 types of front-of-package label designs. They will view 3 sets of products (frozen meals, frozen pizzas, and frozen desserts), shown in random order. For each product set, participants will view 3 products shown in random arrangement, each with participants' randomly assigned label shown on the front of package. After viewing all 3 product types, participants will answer questions about explicit weight bias and attribution of responsibility for body weight. Researchers will compare results across label designs. conditions: Weight Prejudice studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 4000 type: ESTIMATED name: Numerical label name: Interpretive text-only label name: Interpretive magnifying glass icon label name: Separated interpretive magnifying glass icon label measure: Explicit weight bias, mean score measure: Attribution of personal responsibility for body weight, mean score sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: The University of North Carolina at Chapel Hill's Gillings School of Global Public Health city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Aline D'Angelo Campos, MPP role: CONTACT phone: 919-966-3215 email: adangelo-campos@unc.edu lat: 35.9132 lon: -79.05584 hasResults: False
|
<|newrecord|> nctId: NCT06293924 id: The PEFLANA Trial briefTitle: Pericardial Fluid Analysis in Recurrent Pericarditis acronym: PEFLANA overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2029-02 date: 2031-02 date: 2024-03-05 date: 2024-03-05 name: ASST Fatebenefratelli Sacco class: OTHER briefSummary: This clinical trial aims to examine the biochemical and cytological features of pericardial effusion during acute and recurrent pericarditis and to understand the molecular factors responsible for pathogenesis. The primary objective of this study is to identify and validate diagnostic criteria in pericardial fluid analysis that can differentiate patients with acute and recurrent pericarditis from those with only pericardial fluid but no inflammation.
|
This study will enroll patients with acute pericarditis who require pericardiocentesis for either diagnostic or therapeutic purposes. Two control groups will also be included: one consisting of patients who need cardiac surgery with a collection of pericardial fluid, and the other consisting of patients who require pericardiocentesis for non-inflammatory pericardial effusion. The purpose of the study is to compare the cell activation status and cytokines present in pericardial fluid during acute pericarditis with those present during other pericardial pathologies. conditions: Acute Pericarditis conditions: Pericardial Effusion conditions: Pericardial Disease conditions: Pericardial Fluid Exudate conditions: Autoinflammatory Disorders conditions: Autoinflammatory Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 432 type: ESTIMATED name: Pericardiocentesis name: Pericardiotomy name: Cytofluorometry and Gene expression analysis measure: Differences in cell counts among inflammatory and non-inflammatory pericardial effusion. measure: Difference in biochemical parameters among inflammatory and non-inflammatory pericardial effusion measure: Difference of IL-1 expression in pericardial fluid cells among inflammatory and non-inflammatory pericardial effusion measure: Differences of inflammatory cytokine expression in pericardial fluid cells among inflammatory and non-inflammatory pericardial effusion measure: Differences of gene expression in pericardial fluid cells among inflammatory and non-inflammatory pericardial effusion measure: Differences of gene expression in pericardial fluid and blood cells during pericarditis measure: Differences in cytokine and other molecule concentrations between pericardial fluid and blood cells in pericarditis measure: Correlation of inflammatory mediators in pericardial fluid and clinical features during pericarditis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06293911 id: 2024-POSTBIOTICSDOWNSYNDROME briefTitle: Clinical Comparison of a Postbiotic-gel With Placebo Gel for Gingival Inflammation in Patients With Down Syndrome overallStatus: ENROLLING_BY_INVITATION date: 2024-03-15 date: 2025-07-17 date: 2025-07-28 date: 2024-03-05 date: 2024-04-26 name: University of Pavia class: OTHER briefSummary: The aim of the study is to evaluate the efficacy of home treatment with a postbiotic-based gel for the management of periodontal inflammation in patients with Down syndrome.
|
Patients will be enrolled at the S.C. Odontostomatologia dell'Azienda Ospedaliera "Ordine Mauriziano di Torino", Turin, Italy. After the collection of the periodontal clinical indexes (BoP%, PCR%, dental mobility, mMGI, compliance and satisfaction questionnaire), patients will undergo a professional mechanical debridement with ultrasonic instruments and glycine powders.
|
Then, they will be randomly divided into two groups according to the home treatment:
|
* in the Trial group Biorepair Plus Parodontgel Intensive (containing microRepair®, hyaluronic acid, Lactobacillus Ferment and Aloe Barbadensis Leaf Juice Powder) will be used once a day for all the duration of the study
|
* in the Control group, a placebo gel without (active ingredients) will be used once a day for all the duration of the study.
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.