Split (1)

train · 22k rows

Record stringlengths 1 197k
<\|newrecord\|> nctId: NCT06340191 id: UJAPIlates1 briefTitle: Cueing and Pilates in Low Back Pain acronym: PIlatesuja overallStatus: COMPLETED date: 2023-05-02 date: 2024-02-20 date: 2024-02-26 date: 2024-04-01 date: 2024-04-01 name: University of Jaén class: OTHER briefSummary: The intervention involved two groups participating in supervised Pilates sessions, twice a week for 8 weeks, featuring a mix of mat and props-based exercises. Group 1 received additional cueing training to enhance alignment, muscle engagement, and movement technique, while Group 2 underwent the same Pilates regimen without this cueing component. conditions: Low Back Pain conditions: Pilates Exercise conditions: Pilates, Core Stability conditions: Mind-body Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 67 type: ACTUAL name: Pilates with cueing name: Pilates without cueing measure: Low back pain measure: Pain report measure: Fear of movement measure: Perceived Stress Scale measure: Pain self-efficacy measure: Patient Impression of Change measure: Body Awareness sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Jaen city: Jaen zip: 23071 country: Spain lat: 37.76922 lon: -3.79028 hasResults: False
<\|newrecord\|> nctId: NCT06340178 id: 2024-00246 briefTitle: CT-guided Lung Biopsy Risk Optimization Method acronym: BROM-I overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2027-04-01 date: 2024-04-01 date: 2024-04-01 name: Insel Gruppe AG, University Hospital Bern class: OTHER briefSummary: The purpose of this randomized controlled study is to evaluate the extent to which injection of a small amount of fluid in the pleural cavity at the biopsy site may reduce the risk of pneumothoraces, in addition to patient positioning to allow biopsy in gravity-dependent areas of the lung. conditions: Pneumothorax conditions: Biopsy, Needle conditions: Risk Factors conditions: Radiology, Interventional studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 198 type: ESTIMATED name: Fluid application during ct-guided lung biopsy measure: Number of patients with pneumothorax measure: Number of patients with bleeding measure: Number of patients with chest tube placement measure: Number of patients with air embolism sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10 city: Bern zip: 3010 country: Switzerland lat: 46.94809 lon: 7.44744 hasResults: False
<\|newrecord\|> nctId: NCT06340165 id: 2023-KS-151 briefTitle: A Real-world Efficacy and Safety Study of Amlotinib for HER2-negative Advanced Breast Cancer overallStatus: RECRUITING date: 2024-02-04 date: 2025-06 date: 2025-06 date: 2024-04-01 date: 2024-04-01 name: The First Hospital of Jilin University class: OTHER briefSummary: This study analyses the efficacy and safety of amlotinib as a study drug in the treatment of HER-2 negative advanced breast cancer in the real world, including the number of treatment lines, monotherapy, combination therapy, and different molecular subtypes of breast cancer. Evidence-based medicine evidence for clinicians. Although the clinical application of amlotinib in breast cancer treatment is a supra-indication drug, in view of its high safety and possible good efficacy for advanced breast cancer, some patients have been clinically adopted to try the treatment after communicating with their families. This study provides evidence for the further use of amlotinib in breast cancer treatment by analysing the efficacy and safety of amlotinib in real-world applications. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 153 type: ESTIMATED name: Anlotinib measure: PFS sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Jilin University status: RECRUITING city: Changchun state: Jilin zip: 130021 country: China name: xu sun role: PRINCIPAL_INVESTIGATOR lat: 43.88 lon: 125.32278 hasResults: False
<\|newrecord\|> nctId: NCT06340152 id: 808385 id: U01HG013189-01 type: NIH link: https://reporter.nih.gov/quickSearch/U01HG013189-01 briefTitle: Multi-Omics for Maternal Health After Preeclampsia acronym: MOM-Health overallStatus: RECRUITING date: 2023-12-20 date: 2028-12 date: 2028-12 date: 2024-04-01 date: 2024-04-01 name: University of California, San Diego class: OTHER name: National Human Genome Research Institute (NHGRI) name: Vanderbilt University Medical Center briefSummary: To develop strategies to identify postpartum women at risk for adverse cardiovascular outcomes and provide them with preventative therapies. conditions: Pre-Eclampsia conditions: Pregnancy Induced Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1100 type: ESTIMATED measure: Preeclampsia measure: Gestational hypertension measure: Postpartum hypertension measure: Postpartum cardiovascular disease measure: Other cardiovascular disease sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of California, San Diego status: RECRUITING city: San Diego state: California zip: 92037 country: United States name: Samantha La Belle role: CONTACT phone: 858-249-5985 email: slabelle@health.ucsd.edu name: Louise Laurent, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Marni Jacobs, PhD role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 hasResults: False
<\|newrecord\|> nctId: NCT06340139 id: Riphah/RCRAHS-ISB/REC/01742 briefTitle: Vestibulo-Ocular Reflex for Balance and Stimming in Autism Spectrum Disorder overallStatus: RECRUITING date: 2024-03-20 date: 2024-07-20 date: 2024-08-20 date: 2024-04-01 date: 2024-04-01 name: Riphah International University class: OTHER briefSummary: Autism spectrum disorder is a neurodevelopmental disorder that encompasses a number of disorders specifically affecting social skills, Communication and present with Rapid repetitive behaviors. Autism spectrum disorder also presents with inability of body to process sensory information which can causes symptoms such as balance deficits, sensitivity to certain sounds or an exaggerated reaction to a normal stimulus. Autism spectrum disorder can affect the quality of life of an individual to a severe extent. This disorder due to sensory processing deficits also shows difficulty in motor planning, coordination and execution of tasks which can make performing activities of daily living highly difficult to perform. It is called a developmental disorder because it affects the growth. Milestones are often delayed in individuals with autism. Due to these deficits individual with autism if not provided with therapies at the right age can stay dependent on caretaker for their whole life. Rapid repetitive behaviors also known as self-stimulatory behaviors are a way to compensate with anxiety, difficulty in processing sensory information and are often used to stimulate themselves to feel calm. Though not a diagnostic symptom autism often still presents with vestibular dysfunction which affects the balance. Several individuals with autism have showed abnormal vestibular ocular reflexes; abnormally long latency of saccades. Rehabilitation protocol of Autism often includes symptomatic treatment and several therapy protocols such as physical therapy, occupational therapy, applied behavior analysis therapy and play therapy. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: conventional treatment name: experimental treatment measure: Aberrant behavior checklist measure: Berg Balance Scale (BBS) measure: Repetitive Behavior Scale - Revised measure: Functional Reach Test sex: ALL minimumAge: 13 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: zamam autism Centre status: RECRUITING city: Islamabad country: Pakistan name: Rahim Hussain role: CONTACT lat: 33.72148 lon: 73.04329 hasResults: False
<\|newrecord\|> nctId: NCT06340126 id: REC/RCR & AHS/23/0567 briefTitle: Effects of Active Tissue Release Techniques on Groin Pain in 2nd Trimester of Pregnancy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-09-20 date: 2024-10-05 date: 2024-04-01 date: 2024-04-01 name: Riphah International University class: OTHER briefSummary: The study will focus on the effects of active tissue release techniques on groin pain, hip range of motion, and functional disability in 2nd trimester of pregnancy. This will be a randomized controlled trial conducted on 30 participants from Prime Care Hospital. Pregnant women in the second trimester aged between 25 to 35 years, who have groin or round ligament pain will be included in this study. A sample of 30 will be divided into 2 groups. Group A will undergo treatment of active release techniques for 10 minutes thrice a week with no home plan of home relaxation exercises. In contrast, Group B will combine treatment of active release technology with home relaxation exercises. Treatment will be given for 4 weeks and pain will be assessed before and after the treatment through (NPRS) scale. Functional disability will be measured before and after the treatment through Quebec scale and Force Disability Scale Questionnaire in both groups. conditions: Groin Strain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Active release techniques name: Relaxation exercises measure: Numeric Pain Rating Scale measure: The Quebec questionnaire: measure: Goniometer: To measure range of motion: sex: FEMALE minimumAge: 25 Years maximumAge: 35 Years stdAges: ADULT facility: Prime Care Hospital city: Faisalābad state: Punjab zip: 38000 country: Pakistan name: Ghulam Fatima, PhD* role: CONTACT phone: 03034073057 email: ghulam.fatima@riphah.edu.pk lat: 31.41554 lon: 73.08969 hasResults: False
<\|newrecord\|> nctId: NCT06340113 id: REC/RCR & AHS/23/0108 NASHIA briefTitle: Mulligan and Mckenzie Exercises Alongwith Stabilization Exercises in Patients With Chronic Neck Pain overallStatus: RECRUITING date: 2023-11-20 date: 2024-06-01 date: 2024-06-01 date: 2024-04-01 date: 2024-04-03 name: Riphah International University class: OTHER briefSummary: The goal of this \[type of study: Randomized control trial\] is to \[ compare the effectiveness of Mulligan and McKenzie Exercises along with stabilization exercises on pain, range of motion and disability \] in \[ in patients with chronic neck pain\].The main question it aims to answer is:
* Wether Mulligan is more effective or Mckenzie exercises along with stabilization exercises in the treatment of patients with chronic neck pain Group 1 will recieve Mulligan and stabilization exercises Group 2 will recieve Mckenzie and stabilization exercises conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: MCKENZIE AND STABILIZATION EXERCISES name: MULLIGAN AND STABILIZATION EXERCISES measure: Numeric pain rating scale measure: Neck Disability Index (NDI) measure: Goniometer sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Riphah international university status: RECRUITING city: Lahore state: Punjab zip: 54000 country: Pakistan name: Muhammad Sanaullah, MS role: CONTACT phone: 03224819253 email: muhammad.sanaullah@riphah.edu.pk lat: 31.558 lon: 74.35071 hasResults: False
<\|newrecord\|> nctId: NCT06340100 id: REC/MS-PT/01832 briefTitle: Association of History of Concussion With Vestibular Impairment and Cognitive Function in Sports Athletes overallStatus: RECRUITING date: 2024-03-23 date: 2024-04-23 date: 2024-06-02 date: 2024-04-01 date: 2024-04-01 name: Riphah International University class: OTHER briefSummary: This study investigates the potential relationship between prior concussions and their impact on both vestibular function and cognitive abilities in athletes participating in sports. conditions: Concussion, Mild conditions: Vestibular Impairment conditions: Cognitive Impairment studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 115 type: ESTIMATED name: find association between vestibular impairment , cognitive fiunction with concussin measure: CANTU measure: Sports concussion office assesment tool 6 sex: ALL minimumAge: 18 Years maximumAge: 36 Years stdAges: ADULT facility: HAYATABAD Sports complex status: RECRUITING city: Peshawar state: Khyber Pakhtun Khawan zip: 24730 country: Pakistan name: Nadia Ishtiaq, MSOMPT role: CONTACT phone: +922486977541 email: Nadia.Ishtiaq@riphah.edu.pk name: MAHEEN GUL, MSSPT* role: CONTACT phone: +923319533510 name: Maheen Gul, MS*SPT role: PRINCIPAL_INVESTIGATOR lat: 34.008 lon: 71.57849 hasResults: False
<\|newrecord\|> nctId: NCT06340087 id: 706014-3 briefTitle: Impact Hesperetin in Combination With Sucrose on Blood Glucose Regulation overallStatus: RECRUITING date: 2024-03-31 date: 2024-08-31 date: 2025-03-31 date: 2024-04-01 date: 2024-04-23 name: University of Vienna class: OTHER briefSummary: The aim of this cross-over intervention study is to investigate the influence of hesperetin applied in combination with sucrose in comparison to an equally sweet-tasting sucrose-only solution and an isocaloric sucrose-only solution on markers of energy metabolism conditions: Blood Glucose Fluctuations conditions: Hunger studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: 10% Sucrose name: Sucrose+ Hesperetin name: 7% Sucrose measure: Change in blood glucose concentration measure: Change in appetite score measure: Change in food intake measure: Change in regulating hormones sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Christian Doppler Laboratory for Taste Research status: RECRUITING city: Vienna zip: 1090 country: Austria name: Barbara Lieder, PhD role: CONTACT phone: +431427770611 email: Barbara.Lieder@univie.ac.at lat: 48.20849 lon: 16.37208 hasResults: False
<\|newrecord\|> nctId: NCT06340074 id: STUDY00010282 briefTitle: Helping Educational Leadership Mobilize Evidence acronym: HELM overallStatus: COMPLETED date: 2022-08-28 date: 2023-06-01 date: 2023-06-07 date: 2024-04-01 date: 2024-04-01 name: University of Washington class: OTHER briefSummary: Many universal, evidence-based prevention practices (EBPPs) have been developed to prevent SEB problems, typically in elementary schools, but progress toward widespread implementation has been slow and few efforts have been made to develop and test interventions to enhance EBPP implementation in schools. Schools leaders (e.g., principals) are key to decision making and implementation of EBPPs, and their leadership has been shown to be consistently linked to student outcomes through their intentional efforts to support teacher adoption and use of innovative programs. Helping Educational Leaders Mobilize (HELM) Evidence is a pragmatic, multifaceted, organizationally-focused implementation strategy targeting the implementation leadership and implementation climate of school buildings (through principals) to enhance the adoption and delivery of EBPPs in elementary schools. This pilot study, part of the larger HELM project to adapt and test the strategy based on an existing leadership intervention, Leadership and Organizational Change for Implementation (LOCI), will be implemented in the context of Positive Greetings at the Door (PGD), a universal school-based EBPP previously demonstrated to reduce disruptive behavior and increase academic engagement. conditions: Behavior, Child studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: PARTICIPANT count: 333 type: ACTUAL name: HELM name: Implementation Attention Control (IAC) measure: Proximal Outcome: Strategic Implementation Leadership measure: Proximal Outcome: Strategic Implementation Climate measure: Proximal Outcome: Implementation Citizenship Behavior measure: Proximal Outcome: Implementation Initiative Stability measure: Implementation Outcome: Fidelity and Sustainment - Observed measure: Implementation Outcome: Fidelity and Sustainment - Self Report measure: Implementation Outcome: Reach measure: Implementation Outcome: Facilitators and Barriers to Implementation measure: Implementation Outcome: Implementation Cost measure: Student Educational Outcomes measure: Student Behavioral Outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Washington School Mental Health Assessment, Research, and Training (SMART) Center city: Seattle state: Washington zip: 98115-8160 country: United States lat: 47.60621 lon: -122.33207 hasResults: False
<\|newrecord\|> nctId: NCT06340061 id: Qianyu Wu briefTitle: The Aim of This Study is to Investigate the Correlation Between the Severity of Glaucoma and Corneal Biomechanics as Well as Anterior Chamber Parameters. overallStatus: ACTIVE_NOT_RECRUITING date: 2022-10-20 date: 2024-12-31 date: 2024-12-31 date: 2024-04-01 date: 2024-04-01 name: Henan Provincial People's Hospital class: OTHER briefSummary: The ocular biomechanical differences between the normal control group and primary glaucoma patients, including those treated with conventional medication, laser therapy, and surgery, were compared. Additionally, an investigation was conducted to explore the relationship between anterior chamber parameters, corneal biomechanics, and the severity of glaucoma conditions: Glaucoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Observational study measure: IOP measure: bIOP measure: ACD measure: ACW measure: SSI measure: VF sex: ALL minimumAge: 22 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henan Provincial People's Hospital city: Zhengzhou state: Henan zip: 450003 country: China lat: 34.75778 lon: 113.64861 hasResults: False
<\|newrecord\|> nctId: NCT06340048 id: XC Liu briefTitle: Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure overallStatus: RECRUITING date: 2023-09-05 date: 2024-09-05 date: 2025-03-05 date: 2024-04-01 date: 2024-04-01 name: Help Therapeutics class: INDUSTRY name: TEDA International Cardiovascular Hospital briefSummary: The purpose of this clinical study is to evaluate the feasibility, safety and efficacy of intramyocardial injection of human induce pluripotent stem cell-derived cardiomyocytes (HiCM-188) during coronary artery bypass grafting (CABG) surgery in patients with severe chronic ischemic heart failure. conditions: Heart Failure studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: HiCM-188 therapy measure: The incidence of major Serious Adverse Events (SAE) measure: Grade 4 or above arrhythmias measure: The incidence of tumor measure: Left ventricular geometry as assessed by cardiac magnetic resonance imaging (MRI) measure: Size of myocardial infarction as assessed by MRI measure: Ventricular wall motion as assessed by MRI measure: Left ventricular ejection fraction as assessed by MRI measure: Cardiac Volumes as assessed by MRI measure: Cardiac output (CO) as assessed by MRI measure: 10.End-diastolic myocardial mass as assessed by MRI measure: Left ventricular ejection fraction (LVEF) as assessed by Echocardiography measure: Fractional shortening (FS) as assessed by Echocardiography measure: Left ventricular dimensions as assessed by Echocardiography measure: Cardiac Volumes as assessed by Echocardiography measure: Mitral valve inflow spectrum(E/A) as assessed by Echocardiography measure: Longitudinal strain as assessed by Echocardiography measure: Myocardial viability as assessed by SPECT measure: Myocardial blood flow as assessed by SPECT measure: NT-proBNP Levels measure: 6-minute walking distance measure: New York Heart Association (NYHA) functional classification measure: Changes of Quality of Life (QoL) as assessed by Minnesota Living with Heart Failure Questionnaire (MLHFQ) measure: Changes of Quality of Life(QOL) as assessed by 36-Item Short Form Survey (SF-36) sex: ALL minimumAge: 35 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: TEDA International Cardiovascular Hospital status: RECRUITING city: Tianjin state: Tianjin zip: 300457 country: China name: Xiaocheng Liu role: CONTACT phone: +86-022-65208030 name: Xiaocheng Liu role: PRINCIPAL_INVESTIGATOR lat: 39.14222 lon: 117.17667 hasResults: False
<\|newrecord\|> nctId: NCT06340035 id: 20230901 briefTitle: Percutaneous Peripheral Nerve Stimulation of Gluteus Nerves to Improve Hip Strength and Power overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-01 date: 2024-04 date: 2024-06 date: 2024-04-01 date: 2024-04-01 name: Hospital Clinic of Barcelona class: OTHER briefSummary: The goal of this pilot clinical trial is to evaluate whether the ultrasound-guided percutaneous peripheral nerve stimulation through a needle results in greater gains in strength and power compared to the administration of current through surface electrodes in patients undergoing strength and power assessments. The main questions it aims to answer are:
Does percutaneous stimulation of the superior and inferior gluteal nerves using ultrasound-guided needles enhance strength and power more effectively than transcutaneous stimulation through electrodes?
Is the effectiveness of current delivery significantly different between percutaneous and transcutaneous methods when assessed with a linear encoder in a standarized hip extension exercise?
Participants will:
Be randomized into two groups: one undergoing ultrasound-guided percutaneous stimulation of the gluteal nerves (experimental group) and the other undergoing transcutaneous stimulation through electrodes (control group).
The same stimulation protocol at 10 Hz frequency with the maximum muscle contraction evoked without pain will be performed in both groups. Then, the participants will undergo strength and power assessment before and after therapy administration using a linear encoder in a hip extension exercise.
Researchers will compare the experimental group to the control group to see if the method of current delivery (percutaneous vs. transcutaneous) has a significant impact on the gains in strength and power. This comparison is based on the hypothesis that percutaneous delivery of current, guided by ultrasound, is more effective than simply positioning a surface electrode for transcutaneous stimulation. The evaluation of strength and power will be performed through a linear encoder that measures peak strength and concentric power in each repetition, conducted by a blind operator unaware of the patients' group allocations. conditions: Chronic Pain conditions: Chronic Knee Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This pilot study utilizes a randomized parallel-group design, focusing on procedure feasibility for future clinical trials, in line with extended CONSORT guidelines for pilot studies. Participants, selected through a convenience sampling method due to their chronic knee pain, received pre- and post-treatment evaluations to assess the effect on gluteal muscle function. Post-informed consent, participants were allocated to either TENS or ultrasound-guided percutaneous nerve stimulation via a computer-generated randomization process executed with GraphPad Software (San Diego, CA, USA), ensuring a balanced 1:1 ratio. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: In the study, blinding will be implemented to minimize bias. The evaluating clinician will be blinded to participant group assignments, ensuring assessments are unbiased. Similarly, the data analyst will also be blinded, analyzing data without knowledge of group allocations to maintain impartiality. Data will be handled objectively, with statistical methods applied blindly to compare treatment groups. Despite challenges in completely blinding participants due to the distinct nature of interventions, every effort will be made to minimize potential bias. whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 12 type: ACTUAL name: TENS name: Percutaneous Peripheral Nerve Stimulation measure: Hip Extension Concentric Peak Power (Watts) measure: Hip Extension Concentric Peak Strength (Newtons) measure: Concentric Phase Velocity (m/s) measure: Maximum Strength (1RM in kgs) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Barcelona city: Barcelona zip: 08036 country: Spain lat: 41.38879 lon: 2.15899 hasResults: False
<\|newrecord\|> nctId: NCT06340022 id: 2022-31 briefTitle: Pain and Anxiety Levels of Sleeperone Electronic Anesthesia System in Pediatric Patients overallStatus: COMPLETED date: 2023-03-13 date: 2023-10-02 date: 2023-11-15 date: 2024-04-01 date: 2024-04-01 name: Eskisehir Osmangazi University class: OTHER briefSummary: The conventional method used for dental anesthesia in children is the administration of a local anesthetic solution by injection. Although this process successfully eliminates pain during the procedure, it continues to be a problem for many children in terms of dental anxiety before and during anesthesia administration.
The aim of this study is to compare intraosseous anesthesia with SleeperOne® 5, a computer-assisted local anesthesia system, with conventional local anesthesia techniques in terms of pain and anxiety. conditions: Dental Anxiety conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study was a single-center randomized controlled trial using a split mouth design with a 1:1 split ratio. primaryPurpose: OTHER masking: NONE count: 32 type: ACTUAL name: Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) scale name: Face Image Scale (FIS) scoring system name: Visual Analogue Scale (VAS) name: pulse rate measure: The pulse rate measurements before and after the anesthesia techniques measure: Determine the anxiety level before the procedures measure: The anxiety measurements before and after the anesthesia techniques measure: The pain measurements during the anesthesia techniques sex: ALL minimumAge: 8 Years maximumAge: 12 Years stdAges: CHILD facility: Eskisehir Osmangazi University Faculty of Dentistry, Department of Pediatric Dentistry city: Eskişehir country: Turkey lat: 39.77667 lon: 30.52056 hasResults: False
<\|newrecord\|> nctId: NCT06340009 id: REC/01743 briefTitle: MIME THERAPY vs MOTOR IMAGERY TECHNIQUE in Bell's Palsy overallStatus: RECRUITING date: 2024-03-22 date: 2024-08-22 date: 2024-08-25 date: 2024-04-01 date: 2024-04-01 name: Riphah International University class: OTHER briefSummary: Bell's palsy, characterized by unilateral paralysis/paresis of facial muscles, is a condition with a significant impact on individuals' lives. It was first identified by scientist Sir Charles Bell, and its sudden onset can lead to social, psychological, and emotional distress. Left untreated, Bell's palsy can have long-lasting effects on a patient's quality of life, including loss of facial muscle control, emotional stress, and communication difficulties. Rehabilitation protocols encompass various physical therapy techniques, among which Mime therapy and Motor imagery technique have shown promise. conditions: Bell Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: mime therapy name: motor imagery measure: House-Brackmann Scale (HBS) measure: Facial Disability Index (FDI) measure: Sunnybrook Facial Grading System measure: Synkinesis Assessment Questionnaire (SAQ) sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Muzaffar Hospital status: RECRUITING city: Sargodha country: Pakistan name: Mulazam Imran, MS-NMPT* role: CONTACT lat: 32.08361 lon: 72.67111 hasResults: False
<\|newrecord\|> nctId: NCT06339996 id: KSVGH24-CT1-10 briefTitle: Male Supplements for Sperm Quality and Aging overallStatus: RECRUITING date: 2024-03-26 date: 2024-03-30 date: 2024-09-30 date: 2024-04-01 date: 2024-04-02 name: Kaohsiung Veterans General Hospital. class: OTHER briefSummary: This study investigates the effects of a new supplement on sperm quality in men with poor sperm quality. Fifty patients will receive the supplement for three months, followed by semen analysis and assessment of sperm aging and mitochondrial function. Changes in sexual function and aging symptoms will also be evaluated. conditions: Unrecognized Condition studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Male supplement measure: Semen analysis measure: oxygen consumption of mitochondria measure: mitochondrial function measure: sexual function measure: aging symptoms sex: MALE minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Kaohsiung Veterans General Hospital status: RECRUITING city: Kaohsiung country: Taiwan name: Li-Te Lin role: CONTACT phone: +88673464027 email: litelin1982@gmail.com name: Kuan-Hao Tsui role: CONTACT lat: 22.61626 lon: 120.31333 hasResults: False
<\|newrecord\|> nctId: NCT06339983 id: REC/RCR & AHS/23/0566 briefTitle: Effects of Scar Mobilization Versus Myofascial Cupping Technique on Cesarean Scar overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-09-20 date: 2024-10-05 date: 2024-04-01 date: 2024-04-01 name: Riphah International University class: OTHER briefSummary: Study focuses on comparing the effects of manual scar mobilization and myofascial cupping techniques on the outcomes of pain, physical characteristics, and appearance of cesarean scars. The study aims to contribute valuable insights into tailored interventions for improving cesarean scars. The randomized clinical trial will involve 52 participants, primigravida women aged 20 to 40 with completely healed but painful cesarean scars. Excluding those with previous scar therapy or infectious scars, the participants will be divided into two groups, with Group A receiving manual scar mobilization therapy and Group B receiving myofascial cupping therapy, both administered twice a week for four weeks. Pain assessment will be conducted using a numeric pain rating scale (NPRS), while physical characteristics and appearance will be evaluated using the Manchester Scar Scale for cesarean scars (MSS). The data collected will be analyzed using SPSS version 29. conditions: Cesarean Section; Complications, Wound, Hematoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 52 type: ESTIMATED name: Manual Scar Mobilization Therapy: name: Myofascial Cupping Therapy: measure: Numeric Pain Rating Scale measure: Manchester Scar Scale (MSS) sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Kulsoom Shoukat Medical Complex city: Faisalābad state: Punjab zip: 3800 country: Pakistan name: Ghulam Fatima, PhD* role: CONTACT phone: 03034073057 email: ghulam.fatima@riphah.edu.pk lat: 31.41554 lon: 73.08969 hasResults: False
<\|newrecord\|> nctId: NCT06339970 id: REC/RCR & AHS/23/0199 iram briefTitle: Effects of Slider Versus Tensioners Nerve Gliding in Cervical Radiculopathy. overallStatus: RECRUITING date: 2023-11-23 date: 2024-06-01 date: 2024-06-01 date: 2024-04-01 date: 2024-04-01 name: Riphah International University class: OTHER briefSummary: This study will be a randomized clinical trial in which Slider versus Tensioners Nerve Gliding Technique along with Mulligan Spinal Mobilization will be applied on the individuals with cerviculorediculopathy and changes will be recorded using different methods and tools. Convenient sampling technique will be used to collect the data. The sample size of 40 patients will be recruited. Patients will be randomly allocated into two different groups through sealed envelope method.20 patients will be allocated in each group A will be treated with Slider Nerve Gliding Technique along with Mulligan Spinal Mobilization Technique; Group B will be treated with Tensioners Nerve Gliding Technique along with Mulligan Spinal Mobilization Technique .Numeric Pain Rating Scale (NPRS), Neck Disability Index (NDI) and goniometer will be used as Data collecting tools. After data collection from defined study setting, data will be entered and analyzed. conditions: Cervical Radiculopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 42 type: ESTIMATED name: Slider Nerve Gliding Technique along with Mulligan Spinal Mobilization Technique name: Tensioners Nerve Gliding Technique along with Mulligan Spinal Mobilization Technique measure: Numeric Pain Rating Scale measure: Neck disability index measure: Goniometer sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Sehat Medical Compolex status: RECRUITING city: Lahore state: Punjab zip: 54000 country: Pakistan name: Iram Dalawar, DPT role: CONTACT phone: 03056087141 email: driramdalawar68@gmail.com name: Iram Dalawar role: PRINCIPAL_INVESTIGATOR lat: 31.558 lon: 74.35071 hasResults: False
<\|newrecord\|> nctId: NCT06339957 id: STUDY00006394 briefTitle: Rheumatology Diet Study overallStatus: RECRUITING date: 2024-03-01 date: 2024-07-01 date: 2024-07-01 date: 2024-04-01 date: 2024-04-01 name: University of Central Florida class: OTHER briefSummary: This study aims to collect information on rheumatology patients' dietary habits, autoimmune disease activity, dietary changes, disease symptom improvements, and perceptions on their dietary habits and how it affects their autoimmune disease. The main objective is to see if rheumatology patients change their dietary habits after their diagnosis of an autoimmune disease and if it subjectively improved their disease symptoms. It will also look at rheumatology patients' expectations for their rheumatologist when it comes to dietary advice and what resources they used to choose their new dietary habits. The study also seeks to measure the interest that rheumatology patients have in pursuing dietary changes as a means of controlling the symptoms of their autoimmune disease. It is expected that patients who changed their eating habits to healthier diets such as a Mediterranean diet would report less severe autoimmune disease symptoms. There are limited dietary recommendations for the management of many rheumatological diseases, so this study seeks to assess rheumatology patients' willingness to try dietary modifications, what improvements they had, and why they decide to make these changes in light of limited information. conditions: Diet Habit conditions: Rheumatologic Disease conditions: Autoimmune Diseases conditions: Rheumatoid Arthritis conditions: Psoriatic Arthritis conditions: Ankylosing Spondylitis conditions: Dermatomyositis/Polymyositis conditions: Sjogren's Syndrome conditions: Systemic Lupus Erythematous conditions: Scleroderma conditions: Fibromyalgia studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 500 type: ESTIMATED measure: To determine how diet habits and activity affects autoimmune diseases using the proper statistical tests for the data set such as t-test and ANOVA. measure: To identify if rheumatology patients change their dietary habits after their diagnosis of an autoimmune disease and if it subjectively improved their disease symptoms. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCF Health Clinics status: RECRUITING city: Orlando state: Florida zip: 32827 country: United States lat: 28.53834 lon: -81.37924 hasResults: False
<\|newrecord\|> nctId: NCT06339944 id: REC/RCR& AHS/23/0198RubabTalib briefTitle: Effects of Sensory Motor Training and Kinesthetic Exercises in Knee Osteoarthritis. overallStatus: RECRUITING date: 2023-11-23 date: 2024-06-01 date: 2024-06-01 date: 2024-04-01 date: 2024-04-03 name: Riphah International University class: OTHER briefSummary: In this study i will see the effects of kinesthetic exercises and sensory motor training on pain and range of motion in patients with knee OA. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 34 type: ESTIMATED name: sensory motor training name: kinesthetic exercises measure: VAS measure: goniometer measure: WOMAC questionaire measure: joint position sense test sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: Tariq Hospital status: RECRUITING city: Sheikhupura state: Punjab zip: 39350 country: Pakistan name: Rubab Talib, MS role: CONTACT phone: 03040442101 email: rubabtalib111@gmail.com lat: 31.71306 lon: 73.97833 hasResults: False
<\|newrecord\|> nctId: NCT06339931 id: REC/RCR &AHS/23/0181 briefTitle: Lumber Spine Mobilization and Spinal Traction on Lumber Radiculopathy. overallStatus: RECRUITING date: 2023-11-23 date: 2024-06-01 date: 2024-06-01 date: 2024-04-01 date: 2024-04-01 name: Riphah International University class: OTHER briefSummary: Lumber radiculopathy, also known as sciatica, is a condition that causes pain in the lower back and legs due to irritation or compression of the spinal nerves. group between 20 and 50 years old. This study will explore the effects of lumbar spine mobilization with leg movement and spinal traction with and without belt in patients with pain and functional limitations due to lumbar radiculopathy. A randomized control trial will be conducted at Atta Jaspal Hospital and Trauma Center through convenient sampling technique on 44 patients, which will be allocated through simple random sampling through sealed opaque envelopes into groups A and B. Group A will be treated with SMWLM, conventional electrotherapy, and traction without a belt, and Group B will be treated with SMWL, conventional electrotherapy, and lumbar traction with a belt. A pretreatment baseline will be set for pain, ROM, and disability at the lumbar spine by using the NPRS, inclinometer, and ODI questioner. Follow-up will be conducted after 4 weeks of post-treatment sessions. The intensity of pain, range of motion, and disability index will be evaluated using the NPRS, inclinometer, and ODI questionnaire. The data will be analyzed using SPSS software version 26. The conclusion of the study will be based on either accepting or rejecting the null and alternate hypotheses. conditions: Lumbar Radiculopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 44 type: ESTIMATED name: SMWLM combined Spinal traction with belt name: SMWLM combined spinal traction without belt measure: Numeric pain rating scale measure: Inclinometer measure: Oswestry Disability Index sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Atta Jaspal Hospital and ortho trauma center status: RECRUITING city: Bhalwal state: Punjab zip: 40410 country: Pakistan name: Azka Ijaz, DPT role: CONTACT phone: 03171742917 email: azkijaz786@gmail.com name: Azka Ijaz, DPT role: PRINCIPAL_INVESTIGATOR lat: 32.26576 lon: 72.89809 hasResults: False
<\|newrecord\|> nctId: NCT06339918 id: REC/RCR & AHS/23/0570 briefTitle: Combined Effects of Kegel Exercises and 4-7-8 Breathing Technique in Primary Dysmenorrhea overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-09-20 date: 2024-10-05 date: 2024-04-01 date: 2024-04-03 name: Riphah International University class: OTHER briefSummary: A randomized clinical trial will be conducted at Riphah International University QIE Campus in Lahore, using non-probability convenience sampling with 28 participants. Criteria include women aged 14-26, nulliparous, experiencing primary dysmenorrhea, with normal menstrual cycles and the ability to exercise independently. Group A will receive kegel exercises and 4-7-8 breathing techniques over 8 weeks, while Group B will only receive the breathing technique. Assessments will be done on menstrual cycle days, with follow-ups at weeks 4 and 8 using specific scales. Data will be analyzed using SPSS version 27. conditions: Primary Dysmenorrhea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 28 type: ESTIMATED name: KegelExercise name: 4-7-8 breathing technique measure: Numeric Pain Rating Scale measure: WALIDD Primary Dysmenorrhea Intensity Scale measure: Pain Self-Efficacy Questionnaire (PSEQ) sex: FEMALE minimumAge: 14 Years maximumAge: 26 Years stdAges: CHILD stdAges: ADULT facility: Riphah International University Clinic city: Lahore state: Punjab zip: 54700 country: Pakistan name: Ghulam Fatima role: CONTACT phone: +923034073057 email: ghulam.fatima@riphah.edu.pk lat: 31.558 lon: 74.35071 hasResults: False
<\|newrecord\|> nctId: NCT06339905 id: 10840098-772.02-5564 briefTitle: The Effects of EndoActivator on Postoperative Pain and Root Canal Treatment Success overallStatus: COMPLETED date: 2022-01-01 date: 2022-08-31 date: 2023-08-31 date: 2024-04-01 date: 2024-04-01 name: Istanbul Medipol University Hospital class: OTHER briefSummary: This study evaluates postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using EndoActivator for irrigation activation. conditions: Periapical Periodontitis conditions: Root Canal Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 140 type: ACTUAL name: Sonic Activation with EndoActivator name: Control Needle Irrigation measure: change from baseline postoperative pain at 1 week measure: change from baseline periapical index at 1 year sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Istanbul Medipol University, Faculty of Dentistry city: Istanbul state: Esenler country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06339892 id: 2022-3.11/451 briefTitle: HCMV Breakthrough Infections During Letermovir Prophylaxis acronym: CMVbreak overallStatus: RECRUITING date: 2023-01-09 date: 2025-06 date: 2026-03 date: 2024-04-01 date: 2024-04-01 name: Foundation IRCCS San Matteo Hospital class: OTHER name: Ministero della Salute, Italy briefSummary: The goal of this clinical trial is to compare two strategies to monitor human cytomegalovirus (HCMV) infections in transplanted patients receiving letermovir (LTV) as anti-HCMV prophylaxis.
HCMV infection after transplantation is diagnosed by detection of HCMV DNA in blood. However, due to the peculiar mechanism of action of LTV, most episodes of HCMV DNA detection are caused by release in the blood stream of non-infectious HCMV DNA.
In true episodes of productive infection, HCMV DNA in blood is present inside the virion and therefore is resistant to DNAse digestion. Conversely, when non-infectious free-floating HCMV DNA is released in the bloodstream, it will be degraded after treatment of plasma with DNAse and will not be detectable by real-time PCR assays.
Researchers will compare determination of HCMV DNA in blood with or without previous digestion of non-infectious free-floating DNA with DNAse.
In patients of the Control group HCMV DNA will be tested without DNAse digestion. If HCMV DNA is positive, patients will stop LTV prophylaxis and receive antiviral therapy with another drug.
In patients of the Study group HCMV DNA will be tested after DNAse digestion. Only if HCMV DNA is positive after DNAse digestion, patients will stop LTV prophylaxis and receive antiviral therapy with another drug.
The main aim of the study is to demonstrate that, by avoiding inappropriate antiviral therapy during LTV prophylaxis, transplant patients will suffer of lower antiviral-drug-related toxicity. A monitoring strategy able to identify true episodes of HCMV productive infection during LTV prophylaxis will lead to a lower rate of inappropriate antiviral therapy and drug-related toxicity without an increased risk of HCMV disease. conditions: Cytomegalovirus Infections conditions: Cytomegalovirus Viremia conditions: Hematopoietic Stem Cell Transplantation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 140 type: ESTIMATED name: Determination of HCMV DNA in plasma after DNAse digestion. name: Determination of HCMV DNA in blood or plasma. measure: - Proportion of patients with positive HCMV DNAemia developing antiviral drug-related toxicity. measure: Proportion of patients developing HCMV DNAemia during LTV prophylaxis. measure: Proportion of patients developing HCMV disease within day 100 and between day 100 and 360 from transplant (key secondary endpoint) measure: Proportion of patients stopping LTV prophylaxis and shifting to GCV/VGCV/FOS therapy. measure: Proportion of patients requiring GCV/VGCV/FOS therapy between day 100 and 360. measure: Proportion of patients with persisting HCMV DNAemia. measure: Proportion of patients developing neutropenia between day 100 and 360. measure: Proportion of patients developing HCMV-specific T-cell response at day 100, 180, and 360. measure: Proportion of patients developing LTV-resistant HCMV strains. measure: Cumulative incidence of acute or chronic GvHD. measure: Transplant related mortality (TRM), underlying disease relapse, and 1-year survival. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASST-Spedali Civili status: RECRUITING city: Brescia state: BS country: Italy name: Michele Malagola, MD role: CONTACT lat: 45.53558 lon: 10.21472 facility: Fondazione IRCCS Policlinico San Matteo status: RECRUITING city: Pavia state: PV zip: 27100 country: Italy name: Daniele Lilleri, MD role: CONTACT phone: +39 0382 502420 email: d.lilleri@smatteo.pv.it name: Irene Cassaniti, PhD role: CONTACT phone: +39 0382 502420 email: i.cassaniti@smatteo.pv.it lat: 45.19205 lon: 9.15917 facility: ASST-Ospedale Papa Giovanni XXIII status: NOT_YET_RECRUITING city: Bergamo country: Italy name: Alessandra Algarotti, MD role: CONTACT lat: 45.69601 lon: 9.66721 facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna status: NOT_YET_RECRUITING city: Bologna country: Italy name: Francesca Bonifazi, MD role: CONTACT lat: 44.49381 lon: 11.33875 facility: ASST Grande Ospedale Metropolitano Niguarda status: NOT_YET_RECRUITING city: Milano country: Italy name: Arianna Pani, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" status: NOT_YET_RECRUITING city: Reggio Calabria country: Italy name: Barbara Loteta, MD role: CONTACT lat: 38.11047 lon: 15.66129 facility: AOU Policlinico Umberto I status: NOT_YET_RECRUITING city: Roma country: Italy name: Corrado Girmenia, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Policlinico Universitario Agostino Gemelli status: NOT_YET_RECRUITING city: Roma country: Italy name: Patrizia Chiusolo, MD role: CONTACT lat: 41.89193 lon: 12.51133 hasResults: False
<\|newrecord\|> nctId: NCT06339879 id: IRB-2023-1071 briefTitle: Health Effects of Grain Foods in Adults overallStatus: RECRUITING date: 2024-01-18 date: 2026-06-30 date: 2026-12-31 date: 2024-04-01 date: 2024-04-04 name: Purdue University class: OTHER name: Grain Food Foundation briefSummary: This study will assess the effects of eating whole grain foods versus refined grain foods with different amounts of added sugar. It is hypothesized that a diet including grain products will have beneficial effects on taste hedonics, appetite, food/energy intake, body weight, blood pressure, acute and chronic glycemia and acute and chronic lipemia compared to customary diets controlling for added sugars, saturated fats and sodium. conditions: High Whole Grain and Low Sugar conditions: Medium Whole Grain and Low Sugar conditions: Low Whole Grain and Low Sugar conditions: Low Whole Grain and High Sugar studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel assignment primaryPurpose: BASIC_SCIENCE masking: NONE count: 120 type: ESTIMATED name: High Whole Grain, Low Sugar name: Low Whole Grain, Low Sugar name: High Whole Grain, High Sugar name: Low Whole Grain, High Sugar measure: Glycemia measure: Appetite measure: Taste Hedonics measure: Energy Intake measure: Body Weight measure: Systolic and Diastolic Blood Pressure measure: Lipemia sex: ALL minimumAge: 21 Years maximumAge: 60 Years stdAges: ADULT facility: Purdue University status: RECRUITING city: West Lafayette state: Indiana zip: 17907 country: United States name: Richard D Mattes, PhD role: CONTACT phone: 765-494-0662 email: mattes@purdue.edu name: Richard D Mattes, PhD, RD, MPH role: PRINCIPAL_INVESTIGATOR lat: 40.42587 lon: -86.90807 hasResults: False
<\|newrecord\|> nctId: NCT06339866 id: E16734702 briefTitle: The Effect of Two Different Video Showings on Pain and Anxiety in Children Undergoing Adenotonsillectomy overallStatus: ACTIVE_NOT_RECRUITING date: 2023-06-25 date: 2024-06-25 date: 2024-06-25 date: 2024-04-01 date: 2024-04-02 name: Zonguldak Bulent Ecevit University class: OTHER briefSummary: Purpose of the Research: The purpose of the research is to examine the effect of two different video presentations on pain and anxiety in children undergoing adenotonsillectomy.
Type of Research It is planned as a randomized controlled interventional type study to examine the effects of two different video presentations on pain and anxiety in children undergoing adenotonsillectomy. conditions: Pain After Adenotonsillectomy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The population of the research will be all patients who had adenotonsillectomy surgery between the ages of 6-12 in the Ear Nose and Throat Service of Zonguldak Bülent Ecevit University Hospital, and the sample will be all patients who had adenotonsillectomy surgery between the specified dates and who meet the inclusion criteria. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: PARTICIPANT count: 120 type: ACTUAL name: The Effect of Two Different Video Interventions on Pain and Anxiety in Children with Adenotonsillectomy: A Randomized Controlled Study measure: After the intervention, the mean score of the children in the postoperative animation and cartoon group on the Wong Baker Pain Rating Scale will be lower than those in the control group. measure: After the intervention, the mean score of the Children's Anxiety Scale-Stability score of the children in the postoperative animation and cartoon group will be less than those in the control group. sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Mihriye city: Zonguldak zip: 67600 country: Turkey lat: 41.45139 lon: 31.79305 hasResults: False
<\|newrecord\|> nctId: NCT06339853 id: 1-2023-0023 briefTitle: Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia overallStatus: COMPLETED date: 2023-09-07 date: 2024-02-29 date: 2024-02-29 date: 2024-04-01 date: 2024-04-01 name: Yonsei University class: OTHER briefSummary: The purpose of the study was to examine safety and efficacy of cognitive behavioral therapy (CBT)-based wearable integrated digital therapeutics for insomnia patients conditions: Insomnia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ACTUAL name: WELT-IP with wearable devices (Apple/galaxy watch. Oura ring) measure: Change from baseline to week 9 (post-treatment) of ISI measure: Secondary Outcome - Changes from baseline to week 9 of SE measure: Changes from baseline to week 9 of SOL. measure: Changes from baseline to week 9 of WASO. measure: Changes from baseline to week 9 of PHQ-9. measure: Changes from baseline to week 9 of GAD-7. measure: Changes from baseline to week 9 of compliance. sex: ALL minimumAge: 19 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Psychiatry, Severance Hospital city: Seoul, zip: 120-752 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
<\|newrecord\|> nctId: NCT06339840 id: 2024-036-01 briefTitle: The Impact of Lifestyle Intervention on Weight and Fertility in Obese Males overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2027-03-31 date: 2024-04-01 date: 2024-04-01 name: Third Affiliated Hospital of Zhengzhou University class: OTHER briefSummary: Obesity, defined by WHO standards as having a body mass index (BMI) equal to or greater than 30 kg/m², affects approximately 800 million people worldwide. It is evident that obesity has become a serious public health issue, resulting in significant health burdens.
Previous systematic reviews have indicated an association between obesity and male factor infertility. In populations undergoing assisted reproductive technology (ART), some studies have shown a correlation between increased male BMI and adverse ART outcomes. Furthermore, the negative effects of obesity may also be transmitted to offspring through genetic and epigenetic changes in reproductive cell DNA, increasing their risk of obesity, metabolic diseases, or other chronic conditions.
Currently, there is a lack of data on the impact of weight loss in obese men on fertility, and it is unclear which nutritional pattern in lifestyle interventions can more effectively control weight, improve semen quality, and address related endocrine issues in obese men, thereby improving reproductive treatment outcomes.
Based on previous literature, we hypothesize that lifestyle interventions, particularly strict low-carbohydrate diets combined with lifestyle guidance, may offer greater health benefits for obese men. These benefits include effective weight loss, improvement in semen parameters, reproductive metabolic health, quality of life related to reproductive health, and the impact on reproductive treatment outcomes. This provides a basis for non-pharmacological intervention strategies and methods for the health of obese men. conditions: Obesity conditions: Weight Loss conditions: Male Fertility conditions: Artificial Insemination conditions: IVF-ET studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Based on the design of this clinical trial, blinding is not implement ed for participants and care providers. Blinding is only applied to outcome assessors and investigators. Outcome assessors are clinical staff members who are unaware of the group assignments, and data is collected directly from the medical records system by EDC data entry personnel for management (double-checking). Data analysts will directly extract information and data from the EDC database for statistical analysis. Blinding will be revealed upon completion of result analysis. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 38 type: ESTIMATED name: Low-carbohydrate diet group name: Health Education Group measure: Weight measure: Semen parameter- Sperm concentration measure: Semen parameter- Sperm motility measure: Semen parameter- Sperm morphology measure: Semen parameter- Sperm DNA fragmentation index (DFI) measure: Semen parameter- Sperm progressive motility (PR) measure: Semen parameter- Non-progressive motility (NP) measure: Semen parameter- Immotility (IM) measure: body mass index (BMI) measure: Waist circumference measure: Hip circumference measure: Lean mass measure: Fat mass measure: Abdominal fat measure: Visceral fat measure: Blood pressure measure: Heart rate measure: Lipid profile-triglycerides measure: Lipid profile-LDL measure: Lipid profile-HDL measure: Lipid profile-VLDL measure: Lipid profile-total cholesterol measure: Glucose metabolism-fasting glucose measure: Glucose metabolism-OGTT measure: Glucose metabolism-insulin measure: Glucose metabolism-C-peptide measure: Glucose metabolism-HbA1c measure: Sex hormones measure: Adult background measure: Questionnaire - Adult physical activity measure: Questionnaire - Quality of life measure: Questionnaire - Psychological condition measure: Questionnaire - Sleep measure: Spouse's reproductive outcome - Methods of Fertilization measure: Spouse's reproductive outcome - Time to pregnancy measure: Spouse's reproductive outcome - Length of gestational age measure: Spouse's reproductive outcome - Medication use measure: Spouse's reproductive outcome - Delivery mode measure: Spouse's reproductive outcome - Pregnancy complications measure: Spouse's reproductive outcome - Obstetrics complications measure: Fetal and offspring - Apgar score measure: Fetal and offspring - body weight measure: Fetal and offspring - Neonatal fat mass measure: Fetal and offspring - Birth defects/abnormalities measure: Fetal and offspring - length measure: Fetal and offspring - abdominal circumference measure: Fetal and offspring - crown circumference measure: Fetal and offspring - Glucose metabolism measure: Fetal and offspring - Lipid profile measure: Fetal and offspring - Offspring growth factors and hormones measure: Fetal and offspring - Cognitive development of offspring measure: Labs - Semen epigenetics marks measure: Labs - Adult Epigenetics measure: Labs - Cord blood - epigenetics measure: Labs - Cord tissue measure: Labs - Placenta measure: Labs - Placenta - biopsies measure: Labs - Offspring urine measure: Labs - Offspring feces sex: MALE minimumAge: 22 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06339827 id: 2023-102 briefTitle: ASk Questions in GYnecologic Oncology (ASQ-GYO) acronym: ASQ-GYO overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2026-02 date: 2024-04-01 date: 2024-04-01 name: Ira Winer class: OTHER briefSummary: The goal of this clinical trial is to determine the effectiveness of the ASk Questions in GYnecologic Oncology question prompt list (ASQ-GYO QPL) at improving patient self-efficacy, distress, physician trust, and knowledge compared to usual care during new patient gynecologic oncology visits. Also to determine the acceptability of the ASQ-GYO QPL with new gynecologic oncology patients. conditions: Ovarian Cancer conditions: Endometrial Cancer conditions: Cervical Cancer conditions: Vulvar Cancer conditions: Vaginal Cancer conditions: Gestational Trophoblastic Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 70 type: ESTIMATED name: Administration of the ASk Questions in GYnecologic Oncology (ASQ-GYO) Question Prompt List measure: Change in pre- and post-visit self-efficacy scores and compared by trial group measure: Change in pre- and post-visit National Comprehensive Cancer Network (NCCN) Distress Thermometer scores compared by trial group measure: Change in pre- and post-visit Trust in a Physician scores compared by trial group measure: Knowledge Screen measure: Patient perceptions of the Question Prompt List sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Barbara Ann Karmanos Cancer Institute city: Detroit state: Michigan zip: 48201 country: United States name: Ira Winer, M.D. PhD role: CONTACT phone: 313-576-9194 email: iwiner@med.wayne.edu name: Elizabeth Johns role: CONTACT email: hr3132@wayne.edu name: Susan Eggly, PhD role: SUB_INVESTIGATOR name: Elizabeth Johns, MD MS role: SUB_INVESTIGATOR name: Larrissa Mattei, MD role: SUB_INVESTIGATOR name: Anna Gotschlich, PhD role: SUB_INVESTIGATOR name: Wei Chen, PhD role: SUB_INVESTIGATOR name: Sam Robinson, PhD role: SUB_INVESTIGATOR name: Ira Winer, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 42.33143 lon: -83.04575 hasResults: False
<\|newrecord\|> nctId: NCT06339814 id: 05/23-CE briefTitle: Eye Movement Desensitization and Reprocessing Group Treatment for Caregivers of Pediatric Brain Tumor Patients overallStatus: RECRUITING date: 2023-03-10 date: 2024-10 date: 2024-11-30 date: 2024-04-01 date: 2024-04-01 name: IRCCS Eugenio Medea class: OTHER briefSummary: Caregivers of pediatric brain tumor survivors may develop high levels of psychological distress, mostly depression and anxiety, with effects comparable to those of a traumatic event. Several studies suggest that Eye Movement Desensitization and Reprocessing could be a promising treatment in similar clinical populations (i.e. adults with brain tumor), but it has never been used for caregivers of pediatric brain tumor. The aims of the present study will be to test the feasibility of the Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol for caregivers of pediatric brain tumor survivors in a clinical setting and to evaluate its effectiveness in decreasing the psychological distress in this population. The study will be monocentric, and with two parallel branches: the Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol group, who will receive a 4-session treatment, versus the Treatment as Usual condition, who will receive standard support. Emotional distress will be measured before the treatment, immediately after the end of it, and two months later (follow-up), by means of several clinical scales. Twenty-four subjects will be recruited for each group (caregivers and controls). Statistical analysis will be performed to test the effect of the intervention. If a positive outcome occurs, it could offer preliminary results about the validity of the Eye Movement Desensitization and Reprocessing in treating this population's difficulties. conditions: Caregiver Burden studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will be with two parallel branches, thus conforming to a Randomized Group Treatment Trial: Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol (those who will receive Eye Movement Desensitization and Reprocessing treatment plus the standard support) versus Treatment As Usual condition (those who will receive only standard support). The assessment will be performed at the moment of recruitment (T0), after the intervention for the Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol group and after 1 month for the Treatment As Usual condition (T1), and for both 2 months after T1 (T2). primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 48 type: ESTIMATED name: Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol name: Treatment As Usual measure: Impact of Event Scale-Revised-Total score measure: Impact of Event Scale-Revised-Intrusion score measure: Impact of Event Scale-Revised-Avoidance score measure: Impact of Event Scale-Revised-Hyperarousal score measure: Subjective Units of Distress-Total Score measure: State-Trait Anxiety Inventory-State anxiety score measure: State-Trait Anxiety Inventory-Trait anxiety score measure: Beck Depression Inventory-Total score measure: Parenting Stress Index-Total score measure: Parenting Stress Index-Parental stress score measure: Parenting Stress Index-Dysfunctional interaction score measure: Parenting Stress Index-Hard child score measure: Stress Index for Parents of Adolescents-Total stress score measure: Stress Index for Parents of Adolescents-Life restrictions score measure: Stress Index for Parents of Adolescents-Relationship with spouse/partner score measure: Stress Index for Parents of Adolescents-Social alienation score measure: Stress Index for Parents of Adolescents-Incompetence/guilt score measure: Caregiver Burden Inventory-Time-dependence burden score measure: Caregiver Burden Inventory-Developmental burden score measure: Caregiver Burden Inventory-Physical burden score measure: Caregiver Burden Inventory-Social burden score measure: Caregiver Burden Inventory-Emotional burden score measure: Family Assessment Device 3-Problem Solving score measure: Family Assessment Device 3-Communication score measure: Family Assessment Device 3-Roles score measure: Family Assessment Device 3-Affective Responsiveness score measure: Family Assessment Device 3-Affective Involvement score measure: Family Assessment Device 3-Behavior Control score measure: Family Assessment Device 3-General Functioning score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCSEMedea status: RECRUITING city: Bosisio Parini state: Lecco zip: 23842 country: Italy lat: 45.80075 lon: 9.29 hasResults: False
<\|newrecord\|> nctId: NCT06339801 id: HCJSM-24-193 briefTitle: Role of Mucosal Impedance Measurement for the Diagnosis of Gastroesophageal Reflux Disease overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-08-01 date: 2024-04-01 date: 2024-04-01 name: Hospital de Clinicas José de San Martín class: OTHER briefSummary: Existing current tests for diagnosing GERD are suboptimal because they lack adequate sensitivity or specificity. Upper gastrointestinal endoscopy is highly specific for diagnosing GERD, particularly when erosive esophagitis is present (Los Angeles Classification B, C, or D). Nevertheless, its sensitivity is limited, as this scenario is only present in 30% of cases. Most patients will exhibit normal endoscopic findings, indicating Non-Erosive Reflux Disease (NERD). The 24-hour impedance-pH monitoring (MII) is currently considered the gold standard. However, its main limitation is that it can only measure reflux activity over a 24-hour period, in addition to the discomfort caused by the catheter. 6-8 It is noteworthy that 50% of patients with NERD will have pathological reflux, and the other 50% will have a sensory disorder. The importance of making an accurate diagnosis lies in the treatment, which varies in each case.11 Recently, a minimally invasive device was developed and validated in the USA to assess changes in esophageal mucosal impedance. This serves as a tool for evaluating tissue changes associated with chronic reflux. However, this device has recently undergone improvements. This new technology has not been tested yet for GERD diagnosis. The primary benefit would be the ability to diagnose GERD in symptomatic patients with NERD during the initial endoscopy conducted under sedation.
Objectives
The Main objectives of this study are to:
1. Evaluate the diagnostic performance of mucosal impedance measurement.
2. Investigate the mucosal impedance pattern in patients with and without GERD.
Secondary objectives:
1. Evaluate the correlation between the global mucosal impedance measurement vs the first 3cm measurement
2. Evaluate the best probability score to distinguish between GERD and non-GERD Design Prospective, cross-sectional, and analytical study Study Design and Procedures The study will be conducted in the Gastroenterology Department of the Hospital de Clínicas José de San Martin, University of Buenos Aires, Argentina. Following a 4-week screening period during which a proton pump inhibitor (PPI) washout will be performed, and baseline measurements will be taken, all patients will undergo upper gastrointestinal endoscopy with mucosal impedance measurement and 24-hour impedance/pH monitoring. conditions: Gastroesophageal Reflux studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: MiVu measure: diagnostic performance measure: mucosal impedance pattern measure: Correlations measure: Probability score sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06339788 id: HD-MP-106 briefTitle: Pharmacokinetics of HD-P023 and Co-administration of Teneligliptin and Empagliflozin High in Healthy Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-11 date: 2024-04-01 date: 2024-04-02 name: Handok Inc. class: INDUSTRY briefSummary: The purpose of this study is to compare the pharmacokinetics and safety of HD-P023 and coadministration of Teneligliptin and Empagliflozin in healthy adult volunteers conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: HD-P023 name: Teneligliptin name: Empagliflozin measure: Area under the plasma concentration versus time curve (AUCt) of Teneligliptin and Empagliflozin measure: Peak Plasma Concentration (Cmax) of Teneligliptin and Empagliflozin measure: Area under the plasma concentration versus time curve zero to time infinity (AUC∞) of Teneligliptin and Empagliflozin measure: Ratio of AUCt and AUC∞ (AUCt/AUC∞) of Teneligliptin and Empagliflozin measure: Time to peak drug concentration (Tmax) of Teneligliptin and Empagliflozin measure: Volume of distribution (VZ/F) of Teneligliptin and Empagliflozin measure: Clearance (CL/F) of Teneligliptin and Empagliflozin sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06339775 id: 2024318 briefTitle: Blinatumomab for Relapsed Acute B Lymphoblastic Leukemia After Transplantation overallStatus: RECRUITING date: 2023-09-01 date: 2026-12-31 date: 2027-06-30 date: 2024-04-01 date: 2024-04-01 name: Suping ZHANG class: OTHER briefSummary: B-ALL patients received regular follow-up after allogeneic hematopoietic stem cell transplantation, and in case of recurrence, they were given Blinatumomab.
Anti-treatment was followed by DLI, and the second course was performed 1-2 months after DLI.
Patients with positive MRD were treated with Blinatumomab 28μg×5-15 days, followed by DLI treatment.
(MNC infusion is about 5×10\^7/kg\~1×10\^8/kg). Patients with hematologic recurrence were given Blinatumomab 9μg D1-4,11.66μg d5-7,28μg Starting from d8 （8 to 21 days in total）, followed by DLI treatment (infusion of MNC approximately 5×10\^7/kg\~1×10\^8/kg). Objective To observe and analyze the efficacy and side effects of Blinatumomab followed by donor lymphocyte infusion in patients with relapsed acute B lymphoblastic leukemia after allogeneic hematopoietic stem cell transplantation in our hospital. conditions: Acute B-cell Lymphoblastic Leukemia studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Blinatumomab measure: Overall survival measure: Disease-free survival measure: incidence of cytokine release syndrome （CRS） measure: Incidence of acute/chronic graft-versus-host disease （GVHD） measure: hematological adverse reactions Incidence rate sex: ALL maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Zhengzhou University status: RECRUITING city: Zhenzhou state: Henan zip: 450000 country: China name: Suping ZHANG role: CONTACT phone: +8613523510641 email: zsp198612@163.com name: Zhilei BIAN role: CONTACT phone: 037166862272 lat: 32.28034 lon: 119.16999 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-11-15 uploadDate: 2024-03-27T23:22 filename: Prot_000.pdf size: 167222 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-11-15 uploadDate: 2024-03-19T23:43 filename: ICF_001.pdf size: 140825 hasResults: False
<\|newrecord\|> nctId: NCT06339762 id: 2024/03-19 briefTitle: Self-Compassion Training Given to Relatives of Patients in Palliative Care overallStatus: RECRUITING date: 2024-02-13 date: 2024-03-13 date: 2024-04-13 date: 2024-04-01 date: 2024-04-01 name: Firat University class: OTHER briefSummary: The concept of self-compassion is a concept that has been frequently the subject of research lately and has gained importance along with positive psychology. It is also referred to as self-understanding and self-compassion in the literature. The concept of self-compassion used in our study represents the concept of self-compassion in its original form as used in foreign sources. Compassion is classified according to the source to which it is directed or received. It is suggested that there are three different flows: the feeling of compassion that the individual directs from himself to others, the feeling of compassion he receives from others, and the feeling of compassion that he directs directly to his own self. It means showing oneself the same compassion and understanding one does to others, accepting and being open to one's own pain, and being accepting of oneself without being judgmental. Individuals with self-compassion believe that the difficulties, flaws and shortcomings they experience are normal. At the same time, they are aware that being human has characteristics and that everyone can experience these situations. Individuals may be less compassionate towards themselves than they are towards others. Individuals with self-compassion are as understanding, forgiving and loving towards themselves as they are towards other people. conditions: Self-Compassion Training studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Self-Compassion Training measure: Self-Compassion Scale: measure: Care Burden Scale: sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fırat university status: RECRUITING city: Elazığ state: Center zip: 25240 country: Turkey name: Gülcan Bahçecioğlu Turan role: CONTACT phone: 506 557 60 86 lat: 38.67431 lon: 39.22321 hasResults: False
<\|newrecord\|> nctId: NCT06339749 id: [2024] Ethics Review NO.040 briefTitle: Pregnancy Outcomes in Normotensive VS stage1 Hypertension: a Prospective Observational Study overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2025-06-30 date: 2026-02-27 date: 2024-04-01 date: 2024-04-01 name: FANG HE class: OTHER briefSummary: In 2017, the American College of Cardiology (ACC) and American Heart Association (AHA) guidelines built on evidence that elevated blood pressure increases cardiovascular mortality in the general population, Reclassification of BP; however, these diagnostic definitions do not include pregnant women, and whether newly diagnosed stage 1 hypertension affects pregnancy complications remains unclear. In this study, the combination of maternal factors, MAP and PLGF was used to comprehensively analyze the risk factors of preeclampsia through the "Bayesian rule" developed by the British Fetal Medicine Foundation (FMF). According to the guidelines and consensus, the pregnant women were considered to be at high risk when the calculated risk was higher than 1% of the population. To compare the pregnancy outcomes of women with normal blood pressure in the first trimester and stage 1 hypertension in different risk groups, and to find out whether screening for preeclampsia can be omitted for women with normal blood pressure in the first trimester, while screening for preeclampsia should still be performed for women with stage 1 hypertension as an independent moderate risk factor, and finally to optimize the screening strategy for preeclampsia. conditions: stage1 Hypertension conditions: Preeclampsia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 626 type: ESTIMATED name: blood pressure name: Clinical protocols for preeclampsia risk screening measure: preeclampsia measure: premature delivery measure: fetal intrauterine growth restriction measure: Severe complications of preeclampsia sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: FANG HE city: Guangzhou state: Guangdong zip: 510150 country: China name: Fang He, M.D role: CONTACT phone: +86 13724831279 email: hefangjnu@126.com name: Yafei Wang, Master role: CONTACT phone: +86 18716442633 email: 542114919@qq.com lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06339736 id: 23815 briefTitle: Treatment Outcomes in Patients With Muscular Temporo-mandibular Joint Disorders overallStatus: RECRUITING date: 2022-01-10 date: 2025-01 date: 2025-12 date: 2024-04-01 date: 2024-04-01 name: University of Pisa class: OTHER briefSummary: The aim of the present study was to assess the treatment outcomes in patients affected by M-TMDs in terms of pain scores assessed with pressure pain threshold (PPT). The levels of de-pression, anxiety and the Oral-Health Impact profile were also assessed and compared to healthy controls. Patients with a clinical diagnosis of M-TMDs and a control group of healthy subjects were enrolled. At baseline, OHIP-14, PHQ-9 and GAD-7 were administered. PPT was registered at the level of masseter and temporalis muscles. The patients were then treated with oral splints and physio-kinesiotherapy following a standardized treatment protocol. At 6-months follow-up, PPT was registered, and the questionnaires were re-administered to compare treatment outcomes. conditions: TMD conditions: TMD/Orofacial Pain studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Questionnaires administered to all study participants measure: Evaluation of the impact of muscular pain on oral health measure: Evaluation of the impact of muscular pain on anxiety measure: Evaluation of the impact of muscular pain on depression measure: Changes in muscular pain sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pisa status: RECRUITING city: Pisa zip: 56126 country: Italy name: Rossana Izzetti role: CONTACT phone: +39050993037 email: rossana.izzetti@unipi.it name: Rossana Izzetti role: PRINCIPAL_INVESTIGATOR lat: 43.70853 lon: 10.4036 hasResults: False
<\|newrecord\|> nctId: NCT06339723 id: 2024/03-17 briefTitle: Pecha Kuka Method About Percutaneous Endoscopic Gastrostomy for Caregivers Who Care for Palliative Care Patients overallStatus: RECRUITING date: 2024-02-13 date: 2024-03-13 date: 2024-04-13 date: 2024-04-01 date: 2024-04-01 name: Firat University class: OTHER briefSummary: Palliative care; It was started by Dame Cicely Saunders in the 1960s as a hospice for community-based provision. Today, palliative care is defined as care that begins with the patient's diagnosis, symptom management is carried out effectively, and a comprehensive, supportive, humanistic approach is based on the individual and his family. When the literature was examined, no study was found that evaluated the effectiveness of the training given by the Pecha Kuka method to caregivers caring for palliative care patients about percutaneous endoscopic gastrostomy. In addition, it is thought that the results of this research will shed light on identifying problems related to feeding practices in patients fed with PEG tubes and identifying misinformation and practices of caregivers. Determining the knowledge level and initiatives of caregivers regarding percutaneous endoscopic gastrostomy tube feeding practices will contribute to the development of educational activities and effective strategies. Study results may provide important data regarding improving the quality of care given to patients and caregivers after discharge and controlling complication rates. conditions: Pecha Kuka conditions: Palliative Care studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Pecha Kucha measure: Evaluation Form for Feeding Practices with Percutaneous Endoscopic Gastrostomy Tube: measure: Visual Analog Scale -Anxiety: sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fırat university status: RECRUITING city: Elazığ state: Center zip: 25240 country: Turkey name: Gülcan Bahçecioğlu Turan role: CONTACT phone: 506 557 60 86 lat: 38.67431 lon: 39.22321 hasResults: False
<\|newrecord\|> nctId: NCT06339710 id: U1111-1288-5508 briefTitle: Short Benznidazole Regimen for Chronic Phase Chagas Disease Patients acronym: Benlatino overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-01-30 date: 2026-10-30 date: 2024-04-01 date: 2024-04-01 name: Evandro Chagas Institute of Clinical Research class: OTHER briefSummary: Multicentric study on Chagas disease that seeks to evaluate a new treatment regimen using the drug benznidazole. Currently, existing treatment regimens are long and have frequent side effects, which leads to a high dropout rate among patients. The research proposes testing two shorter benznidazole regimens to see if they are as effective as standard treatment, but with fewer side effects.
The study will have 672 participants and will be carried out in four locations, Bolivia and Colombia. The objective is to analyze the efficacy and safety of new treatment regimens, evaluating the parasitological response in comparison with standard treatment. In addition, an economic assessment will be carried out to analyze direct and indirect costs, including procedures associated with the management of adverse events. conditions: Chronic Chagas Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 672 type: ESTIMATED name: benznidazole 300 mg daily 8 weeks measure: Proportion of participants with sustained negative Polymerase Chain Reaction (PCR) during the 24 months of follow-up after treatment. measure: Incidence of Adverse Events (AE) leading to treatment discontinuation during treatment period measure: Proportion of participants with positive PCR at different time points measure: Incidence and severity of clinically relevant events attributed to Chagas disease measure: To measure the quality of life (QoL) of participants measure: To measure the quality of life (QoL) of participants sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Israel Molina city: Minas Gerais state: Belo Horizonte country: Brazil name: CARLA Renata TREVIA role: CONTACT phone: 21996670525 email: renatasantos@cuidachagas.org name: Monique MG Gurgel, Master role: CONTACT phone: +55 21 997248094 email: moniquegurgel@cuiachagas.org name: Andrea Silvestre De Sousa, PHD role: PRINCIPAL_INVESTIGATOR lat: -8.96667 lon: -72.78333 facility: Carla Renata Ferreira Dos Santos Trevia city: Rio De Janeiro state: RJ zip: 22631390 country: Brazil name: Israel IM Molina, PHD role: CONTACT phone: +34 679337605 email: israel.molina@fiocruz.gov name: Monique MG Gurgel, Master role: CONTACT phone: +55 21 997248094 email: moniquegurgel@uidachagas.gov lat: -22.90278 lon: -43.2075 facility: Carla Renata Ferreira dos Santos Trevia city: Rio de Janeiro state: RJ zip: 22790-790 country: Brazil name: Israel IM Molina, PHd role: CONTACT phone: +34 679 33 76 05 email: israel.molina@fiocruz.gov name: Monique MG Gurgel, Master role: CONTACT phone: +55 21 name: Israel IM Molina, PHD role: PRINCIPAL_INVESTIGATOR name: Ana Gabriela AH Herrera, PHD role: PRINCIPAL_INVESTIGATOR name: Maria Ximena MX Escalante Lazcano, PHD role: PRINCIPAL_INVESTIGATOR name: Mario MO Mario Oliveira role: PRINCIPAL_INVESTIGATOR name: Juan JV Carlos Villar role: PRINCIPAL_INVESTIGATOR lat: -22.90278 lon: -43.2075 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-02-14 uploadDate: 2024-03-19T19:03 filename: Prot_000.pdf size: 1319333 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-02-14 uploadDate: 2024-03-19T18:18 filename: ICF_001.pdf size: 392791 hasResults: False
<\|newrecord\|> nctId: NCT06339697 id: 2022-KY-233 briefTitle: Short-term Effects of Bowel Preparation on Gut Microbiome in Patients Undergoing Endoscopic Colon Polypectomy overallStatus: COMPLETED date: 2022-12-01 date: 2023-06-30 date: 2023-06-30 date: 2024-04-01 date: 2024-04-01 name: Zhang Yanli class: OTHER briefSummary: To investigate the role of different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate) on the composition, evolution and recovery of the gut microbiome of patients with colonic polyps undergoing bowel preparation. conditions: Colon Polyp conditions: Cathartic Colon studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 194 type: ACTUAL name: different types of laxatives (compounded polyethylene glycol electrolyte dispersions and compounded sodium pico-sulfate) measure: gut microbiome-taxonomy measure: gut microbiome-heatmap measure: gut microbiome-Alpha Diversity measure: gut microbiome-Beta Diversity measure: gut microbiome-Functional predictions measure: Age measure: Gender measure: Height measure: Weight measure: BMI measure: Whether the enrollee is a smoker measure: Whether the enrollee is a drinker measure: Evaluation of the effectiveness of intestinal cleansing Evaluation of the effectiveness of intestinal cleansing measure: Gastrointestinal Symptom Score measure: adverse event sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China-Japan Friendship Hospital city: Beijing state: Beijing zip: 100029 country: China lat: 39.9075 lon: 116.39723 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2022-12-01 uploadDate: 2024-03-20T22:22 filename: Prot_SAP_000.pdf size: 135642 hasResults: False
<\|newrecord\|> nctId: NCT06339684 id: 2021 0075257 briefTitle: HPV Immunological Markers of Cervical Persistent Infection and Oncogenesis acronym: HPVImmuno overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-08 date: 2026-03-08 date: 2026-03-08 date: 2024-04-01 date: 2024-04-03 name: Foundation IRCCS San Matteo Hospital class: OTHER briefSummary: The aim of this observational study is to build an immunological assay to quantify an immunoscore system for clinical practice, which could identify HPV lesions with a risk of persistent cervical infection, which represents the main predictive factor of neoplastic evolution. A pattern of host immunological factors and HPV-related parameters, in order to identify an algorithm of risk stratification and tailoring treatment will be identified. Finally, in patients with HPV infection, a virus specific immunity after vaccination will be quantified, in order to highlight those patients who have the most significant risk of infection persistence. conditions: HPV-Related Cervical Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ACTUAL measure: Analysis plan for primary end-point measure: Analysis plan for secondary end-points sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Policlinico San Matteo city: Pavia country: Italy lat: 45.19205 lon: 9.15917 hasResults: False
<\|newrecord\|> nctId: NCT06339671 id: PASSAGE briefTitle: Post-operative Complications and Smoking Habits in Colorectal Surgery acronym: PASSAGE overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-09-25 date: 2025-09-25 date: 2024-04-01 date: 2024-04-09 name: IRCCS Ospedale San Raffaele class: OTHER name: Ospedale San Paolo name: Ospedali Riuniti Marche Nord pesaro briefSummary: PASSAGE is a national multicenter retrospective and prospective observational cohort study in which patients who will undergo colorectal surgery will be enrolled. conditions: Colorectal Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1527 type: ESTIMATED measure: Incidence and severity of postoperative complications surgery in three groups measure: Incidence and severity of postoperative complications surgery in NF (non-smokers) group sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prof. Pierpaolo Sileri city: Milan country: Italy name: Pierpaolo Sileri role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06339658 id: TAD-ICG briefTitle: ICG vs Blue Patent as a Tracer in the Performance of TAD in Patients With cN1 Breast Carcinoma After Neoadjuvant Chemotherapy overallStatus: RECRUITING date: 2021-01-01 date: 2026-01-01 date: 2026-01-01 date: 2024-04-01 date: 2024-04-15 name: Hospital Universitari de Bellvitge class: OTHER briefSummary: To validate the use of ICG as a tracer during TAD in patients with cN1 breast carcinoma after neoadjuvant chemotherapy. conditions: Breast Cancer conditions: Axillary Metastases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 43 type: ESTIMATED name: Targeted axillary dissection (TAD) by ICG name: Targeted axillary dissection (TAD) by Blue patent measure: Detection rate of sentinel lymph node measure: Detection rate of sentinel lymph node measure: Adverse effects sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital de Bellvitge status: RECRUITING city: Hospitalet de Llobregat state: Barcelona zip: 08907 country: Spain name: Amparo Garcia-Tejedor, MDPhD role: CONTACT phone: 0034-660223417 email: agarciat@bellvitgehospital.cat lat: 41.35967 lon: 2.10028 hasResults: False
<\|newrecord\|> nctId: NCT06339645 id: P00003121 briefTitle: Intravesical Platelet-rich Plasma Injection in Patients With Interstitial Cystitis/Bladder-A Retrospective Study overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-22 date: 2024-12-31 date: 2024-04-01 date: 2024-04-01 name: Hualien Tzu Chi General Hospital class: OTHER briefSummary: The correlation of safety and effectiveness between intravesical platelet-rich plasma injection in patients with interstitial cystitis/bladder-A retrospective study to evaluate the correlation of safety and effectiveness between intravesical platelet-rich plasma injection of IC/BPS, with age of at least 20-84 years old in Taiwan of either sex with IC/BPS symptoms and proven of IC by cystoscopic hydrodistention. Patients who meet all eligibility requirements for entry into the study of intravesical PRP injection. conditions: Safety and Effectiveness Between Intravesical Platelet-rich Plasma Injection in Patients With Interstitial Cystitis/Bladder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 658 type: ESTIMATED name: PRP measure: Global response assessment (GRA) sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wan Ru Yu city: Hualien City state: Outside U.S./Taiwan zip: 970 country: Taiwan name: Wan Ru Yu role: CONTACT phone: 0925051013 email: wanzu666@gmail.com lat: 23.97694 lon: 121.60444 hasResults: False
<\|newrecord\|> nctId: NCT06339632 id: AVAP-NG 3363 briefTitle: Effects of Transcutaneous Electrical Phrenic Nerve Stimulation and Transcutaneous Electrical Diaphragmatic Stimulation overallStatus: RECRUITING date: 2024-04-01 date: 2024-12-01 date: 2025-03-01 date: 2024-04-01 date: 2024-04-18 name: Hospital Sirio-Libanes class: OTHER name: Hospital Israelita Albert Einstein briefSummary: Transcutaneous electrical phrenic nerve stimulation (TEPNS) and transcutaneous electrical diaphragm stimulation (TEDS) are modalities that use surface electrodes placed on the patients' skin to generate action potentials and contractions of the muscle fibers of the diaphragm. The primary objective will be to evaluate the efficacy of TEPNS and TEDS in healthy adult individuals. Secondary objectives will be to assess the feasibility, safety, and level of discomfort reported by the individual resulting from the application of TEPNS and TEDS. conditions: Diaphragm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The researchers responsible for assessing diaphragm muscle through ultrasound will perform image recordings and captures during the "TEPNS" and "TEDS" intervention moments. Subsequently, the images will be analyzed by a blinded evaluator for the adopted intervention. The analyses will follow the methods described in the "diaphragm muscle mobility" and "diaphragm muscle thickness and thickening fraction" sections. Study participants will also be instructed not to disclose information regarding their experience and sensations during the intervention period, ensuring study blinding. whoMasked: OUTCOMES_ASSESSOR count: 12 type: ESTIMATED name: Transcutaneous electrical phrenic nerve stimulation (TEPNS) name: Transcutaneous electrical diaphragm stimulation (TEDS) measure: Diaphragm mobility measure: Diaphragm thickness measure: Thickening fraction measure: Evaluation of sensory discomfort measure: Safety of TEPNS and TEDS application sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hospital Sírio Libanês status: RECRUITING city: São Paulo zip: 01308-050 country: Brazil name: Renato F RIGHETTI, PhD role: CONTACT phone: 5511987496664 email: refragar@gmail.com name: Renato F Righetti, PhD role: PRINCIPAL_INVESTIGATOR name: Wellington P Yamaguti, PhD role: SUB_INVESTIGATOR name: Ricardo K Nawa, PhD role: SUB_INVESTIGATOR lat: -23.5475 lon: -46.63611 hasResults: False
<\|newrecord\|> nctId: NCT06339619 id: SYSKY-2023-1262-02 briefTitle: Combination Immunotherapy of Adebrelimab With Apatinib and Tegafur for Immune Rechallenge Therapy in Esophageal Squamous Cell Carcinoma overallStatus: RECRUITING date: 2024-03-11 date: 2026-03-01 date: 2026-09-01 date: 2024-04-01 date: 2024-04-01 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: The goal of this single-arm study is to explore the efficacy and safety of Adebrelimab in combination with Apatinib and Tegafur for the treatment of locally advanced or metastatic esophageal squamous cell carcinoma that has failed first-line standard treatment with PD-1 inhibitors in combination with chemotherapy. conditions: Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Adebrelimab name: Apatinib name: Tegafur measure: Objective response rate (ORR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: ≥Grade 3 AEs sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510030 country: China name: Minghui Wang, Dr. role: CONTACT phone: 13826276828 email: wmingh@mail.sysu.edu.cn name: Minghui Wang, Dr. role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06339606 id: 4316 briefTitle: Pregnancy Repository acronym: PR overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2031-04-30 date: 2024-04-01 date: 2024-04-24 name: Sunnybrook Health Sciences Centre class: OTHER briefSummary: An essential part of clinical research is the availability and accessibility of human biospecimens for the identification of biomarkers, new treatments and measurement of response to therapy. Proteins, RNA and DNA can be extracted and studied as well. This is a critical first step in performing many fundamental molecular biology experiments. A variety of biospecimens are utilized for research including but not limited to normal and malignant tissues, blood, and other body fluids.
In order to obtain high-quality biospecimens, they must be acquired serially, stored according to current standards, and matched with clinical information for maximum value. As such, the investigators would like to create a repository of biospecimens collected from pregnant patients who are seen at Mount Sinai Hospital and other research hospitals in Toronto. Mount Sinai provides personnel and infrastructure to serve the largest (7500 births/year) and highest complex Maternity program in Ontario. Of the 7500 patients a year, at least 2500 are considered high risk pregnancies, where there's a possibility of preeclampsia, placenta accreta and a host of other complications. For this study, biological specimens - blood, cervical and placental samples - will be collected from these high-risk groups in order to better understand the causes of the underlying conditions. conditions: Pregnancy Related conditions: Fetal Growth Retardation conditions: Placental Insufficiency conditions: Preeclampsia conditions: Cervix; Pregnancy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 7000 type: ESTIMATED name: Biospecimen collection measure: Biomarker levels measure: Pathology sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06339593 id: 2023-0391 briefTitle: Regional Monitoring of CF Lung Disease overallStatus: RECRUITING date: 2024-01-05 date: 2028-01 date: 2028-01 date: 2024-04-01 date: 2024-04-01 name: Children's Hospital Medical Center, Cincinnati class: OTHER briefSummary: The main reason for this research study is to learn more about some new tests that are being developing for patients with Cystic Fibrosis (CF) to measure changes in the lungs. In this study, the focus will be to learn how stopping Airway Clearance (ACT) and re-starting ACT can affect these tests. These new tests include using a breathable gas called Xenon (Xe) with MRI (magnetic resonance imaging) to improve the pictures of changes in the lungs. The Xenon (Xe) gas that has been treated to have a larger MRI signal (also called hyperpolarized). The other new test is called LCI (Lung Clearance Index) that can measure how well the lungs are working. The MRI machine used in this study has been approved by the U.S. Food and Drug Administration (FDA) and is commercially available for sale in the USA. Hyperpolarized Xe gas is an FDA-approved, inhaled contrast agent for lung ventilation MRI. The new Xe MRI techniques that are being developed and used for this research study are investigational, meaning these new Xe MRI techniques are not FDA approved, but they are similar to FDA-approved techniques that are used clinically at Cincinnati Children's Hospital Medical Center (CCHMC). Xe gas and the new MRI techniques used in this research study have been used for many years in research, including in many research studies conducted at CCHMC like this one. conditions: Cystic Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Hyperpolarized Xe129 measure: Assessing structural and functional lung abnormalities via Xenon MRI measure: Assessing patients who have self-withdrawn airway clearance treatment to determine ventilation abnormalities. measure: Change in Xenon Ventilation Defect Process (VDP) sex: ALL minimumAge: 12 Years maximumAge: 21 Years stdAges: CHILD stdAges: ADULT facility: Cincinnati Children's Hospital status: RECRUITING city: Cincinnati state: Ohio zip: 45229 country: United States name: Carrie Stevens, BS role: CONTACT phone: 513-636-9973 email: carrie.stevens@cchmc.org lat: 39.12713 lon: -84.51435 hasResults: False
<\|newrecord\|> nctId: NCT06339580 id: 324456 briefTitle: Assessment of Volume-targeted Ventilation in Patients With Neuromuscular Disease acronym: VT-NMD overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2026-04 date: 2024-04-01 date: 2024-04-25 name: Guy's and St Thomas' NHS Foundation Trust class: OTHER briefSummary: Assessment of safety and efficacy of volume-targeted ventilation in patients with neuromuscular disease. conditions: Neuromuscular Diseases studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Volume-targeted non-invasive ventilation measure: Mean overnight transcutaneous carbon dioxide measure: Maximum overnight transcutaneous carbon dioxide measure: Overnight desaturation index measure: Visual analogue scale of sleep comfort measure: Health-related quality of life measure: Adherence to ventilation sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guy's and St. Thomas NHS Foundation Trust city: London zip: SE1 7EH country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Guy's & St Thomas' NHS Foundation Trust city: London zip: SE1 9RT country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
<\|newrecord\|> nctId: NCT06339567 id: 671_Hemo-PCOS briefTitle: Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes: French Cross-sectional Study acronym: Hemo-PCOS overallStatus: RECRUITING date: 2024-02-08 date: 2026-02-07 date: 2029-02-07 date: 2024-04-01 date: 2024-04-01 name: Fondation Hôpital Saint-Joseph class: OTHER briefSummary: Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of women of childbearing age. PCOS can be individualized into several phenotypes, taking into account in particular the presence of hyperandrogenism, insulin resistance and BMI. Hyperandrogenism and insulin resistance appear to be important factors in the development of cardiovascular cardiovascular disease. In addition, patients frequently use anti-androgenic and/or contraceptive treatments contraceptives, such as combined hormonal contraception (CHC), the use of which is associated with an increased cardiovascular and thrombo and venous thrombosis (VTE). A meta-analysis published in 2020 by Gariani et al.
based on three large studies, estimated the risk of VTE in women with PCOS after adjustment for obesity and hormone therapy. This risk was significantly higher compared with women without PCOS (pooled OR 1.89, CI95% 1.60-2.24). No study has looked specifically investigated the risk of VTE according to different PCOS phenotypes. Such data would be very useful in clinical practice, as it would enable monitoring, contraceptive treatment and anti-androgenic anti-androgen treatment according to the PCOS phenotype, while limiting risks. Assessing the differences PCOS phenotypes is limited by the large sample size required. required. VTE is a rare event in women of childbearing age, and the number of PCOS phenotypes is high.
PCOS phenotypes. Intermediate markers of VTE risk are used in these situations. These markers are thrombin generation tests (notably ETP) and their sensitivity to activated protein C (nAPCsr) and thrombomodulin (nTMsr), as well as sex-hormone binding globulin (SHBG). conditions: Polycystic Ovary Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 320 type: ESTIMATED name: Thrombotic profile measure: biological procoagulant profile measure: Insuline resistance and weight measure: comparison of procoagulant profile depending on insulin resistance measure: comparison of procoagulant profile depending on hyperangrogenism measure: comparison of procoagulant profile depending on PCOS phenotype measure: comparison of procoagulant profile depending on AMH Rate measure: comparison of QoL score depending on PCOS phenotype sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Hôpital Paris Saint Joseph status: RECRUITING city: Paris country: France name: Juliette COURTIADE MAHLER role: CONTACT email: jcourtiade@ghpsj.fr name: Hélène Beaussier, pharmaD role: CONTACT email: hbeaussier@ghpsj.fr lat: 48.85341 lon: 2.3488 hasResults: False
<\|newrecord\|> nctId: NCT06339554 id: 4806 briefTitle: Alectinib-induced Endocrine Toxicity acronym: TOSS-ALK overallStatus: COMPLETED date: 2018-10-12 date: 2023-10-30 date: 2023-10-30 date: 2024-04-01 date: 2024-04-01 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The experimental Cohort A (male ALK+ ANSCLC patients receiving alectinib), the control Cohort B (female ALK+ ANSCLC patients receiving alectinib) and control Cohort C (male NON-ALK ANSCLC patients) were prospectively evaluated for full hormone assessment of androgen deficiency, AT 8 weeks after treatment start and in case of reported suspected symptoms. Patients with major sexual dysfunctions were referred to endocrinologist. conditions: NSCLC Stage IV studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 98 type: ACTUAL name: Alectinib 150 MG [Alecensa] measure: Incidence of endocrine toxicity in overall ALK-positive measure: Incidence of symptomatic hypogonadism in male ANSCLC patients sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Gemelli IRCCS city: Rome zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False
<\|newrecord\|> nctId: NCT06339541 id: 029-FPO23 briefTitle: The ACC Preclinical Research Platform for Precision Oncology acronym: ACC Platform overallStatus: RECRUITING date: 2023-06-05 date: 2024-06-01 date: 2024-12-01 date: 2024-04-01 date: 2024-04-01 name: Fondazione del Piemonte per l'Oncologia class: OTHER name: Alleanza Contro il Cancro briefSummary: The ACC Preclinical Research Platform for Precision Oncology is a retrospective and prospective observational study focused on the implementation and validation of the application of PDCM (Patient Derived Cancer Models) generated from tissues or cells of patients with neoplastic disease, as a tool to improve molecular and biological knowledge of tumours and to test the efficacy and sensitivity of pharmacological treatments. conditions: Solid Tumor conditions: Hematologic Neoplasms studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 250 type: ESTIMATED measure: number of PDCM (patient derived cancer models) measure: number of Whole Exome Sequencing (WES) e RNA-seq performed measure: number of PDCM shared within the network sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo status: RECRUITING city: Candiolo state: Turin zip: 10060 country: Italy name: Marco Asioli, BSc role: CONTACT phone: +390119933463 email: marco.asioli@ircc.it name: Enzo Medico, MD role: PRINCIPAL_INVESTIGATOR lat: 44.95858 lon: 7.59812 hasResults: False
<\|newrecord\|> nctId: NCT06339528 id: EK-VPl421012021 briefTitle: Potential of Vojta's Reflex Locomotion as a Pre/Induction Method for Uterine Activity: a Pilot Study overallStatus: COMPLETED date: 2021-06-23 date: 2024-01-01 date: 2024-03-01 date: 2024-04-01 date: 2024-04-08 name: Faculty Hospital Kralovske Vinohrady class: OTHER_GOV briefSummary: The Vojta's method is neurophysiological rehabilitation method used to support and induce reflex responses of locomotor and vegetative system. It uses involuntary motor reaction of the body during pressure stimulation of so-called trigger zones. Pregnancy is currently considered a contraindication for using Vojta's therapy to potential risks of inducing regular uterine activity and risk of delivery. The aim of the study is to evaluate changes in uterine activity and also explore the possibility of using this method as a new approach for pre/induction of delivery. conditions: Induced Vaginal Delivery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A total of 40 pregnant patients between 40+0 to 41+0 weeks of gestational age were randomly selected for this study. Stimulation of trigger zones according to Vojta's therapy was applied to 20 of them by a team of licensed physiotherapists while a control group received a sham stimulation carried out by physicians. Cardiotocographic (CTG) recordings were conducted right before and immediately after stimulation. CTG recordings were subsequently blindly evaluated by 2 independent obstetricians. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Stimulation of trigger zones according to Vojta's therapy was applied to 20 of them by a team of licensed physiotherapists while a control group received a sham stimulation carried out by physicians. Cardiotocographic (CTG) recordings were conducted right before and immediately after stimulation. CTG recordings were subsequently blindly evaluated by 2 independent obstetricians. Patients did not know if clinician have skills to stimulate properly according to the Vojta's Reflex Locomotion. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Vojta's Reflex Locomotion name: Sham stimulation measure: Cardiotocographic (CTG) recordings - measure: subjective perception during stimulation sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Faculty Hospital Kralovske Vinohrady city: Praha zip: 11000 country: Czechia lat: 50.08804 lon: 14.42076 hasResults: False
<\|newrecord\|> nctId: NCT06339515 id: DuzceU-SBF-NYS-02 briefTitle: Teaching School Health Nursing Course With Universal Design Model overallStatus: NOT_YET_RECRUITING date: 2024-03-21 date: 2024-06-06 date: 2025-12-01 date: 2024-04-01 date: 2024-04-01 name: Duzce University class: OTHER briefSummary: The aim of this study is to design, implement and evaluate the School Health Nursing course in the undergraduate nursing program using the universal design model. conditions: Nursing Education studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Universal Design Model for Learning primaryPurpose: OTHER masking: NONE count: 27 type: ESTIMATED name: Universal Design Model measure: Critical Thinking Disposition Scale measure: Communication Skills Scale measure: Healthy Living Awareness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nuriye Yıldırım city: Düzce state: Duzce zip: 81620 country: Turkey name: Atiye Erbaş, PhD role: CONTACT phone: +90380 542 11 41 phoneExt: 3533 email: atiyeerbas@duzce.edu.tr name: PhD role: CONTACT name: Nuriye Yıldırım Şişman, PhD role: SUB_INVESTIGATOR name: Fahriye Hayırsever, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.83889 lon: 31.16389 hasResults: False
<\|newrecord\|> nctId: NCT06339502 id: Duzce-U-merve0002 briefTitle: The Effect of the Use of Jigsaw Technique on Nursing Students' Critical Article Reviews and Students' Opinions overallStatus: NOT_YET_RECRUITING date: 2024-03-22 date: 2024-04-22 date: 2024-05-24 date: 2024-04-01 date: 2024-04-01 name: Duzce University class: OTHER briefSummary: Studies have proven that the Jigsaw learning method, one of the innovative learning methods, is an effective educational learning tool for nursing students. For nursing education to be sufficient to provide students with the modern roles required by the profession, students must actively learn instead of a memorized undergraduate education. -Training programs should enable them to participate in the teaching process. One of these programs is cooperative learning methods. The jigsaw learning technique creates a contemporary learning model by creating a positive learning environment, individualizing students and developing a sense of responsibility. No scientific literature has been found regarding the effect of the Jigsaw learning method on teaching critical article reading skills in nursing research courses in nursing education. It is assumed that the data obtained in this study will contribute to the effect of critical article reading training given using the Jigsaw technique, one of the cooperative learning techniques in nursing education, on students' critical article reviews and opinions about the technique. conditions: Education, Distance conditions: Students, Nursing studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 144 type: ESTIMATED name: Jigsaw Technique measure: Critical Thinking Disposition Scale measure: The Kolb Learning Style Inventory-III measure: Self Directed Learning Skills Scale sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Duzce University city: Duzce zip: 81100 country: Turkey name: Atiye Erbaş, PhD role: CONTACT email: atiyeerbas@duzce.edu.tr lat: 40.83889 lon: 31.16389 facility: Düzce University city: Duzce zip: 81100 country: Turkey lat: 40.83889 lon: 31.16389 hasResults: False
<\|newrecord\|> nctId: NCT06339489 id: 2022DZMEC-PG-34 briefTitle: The Bone Metabolism Characteristics of Premature Ovarian Insufficiency acronym: POI overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-01 date: 2025-02-01 date: 2024-04-01 date: 2024-04-02 name: Shi Yun class: OTHER briefSummary: Explore the bone metabolism characteristics of premature ovarian insufficiency. conditions: Premature Ovarian Insufficiency conditions: Bone Diseases, Metabolic conditions: Bone Mineral Density studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED name: Testing the serum levels of bone metabolic markers measure: tartrate resistant acid phosphatase-5b, TRACP-5b measure: bone specific alkaline phosphatase, BALP measure: bone mineral density, BMD sex: FEMALE minimumAge: 18 Years maximumAge: 39 Years stdAges: ADULT facility: Dongzhimen Hospital, Beijing University of Chinese Medicine city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06339476 id: Dilara ÜLGER ÖZBEK briefTitle: Exploring the Complex Links Between Menstrual Irregularity and Cellular Markers overallStatus: COMPLETED date: 2023-06-01 date: 2024-03-10 date: 2024-03-24 date: 2024-04-01 date: 2024-04-03 name: Cumhuriyet University class: OTHER briefSummary: A cross-sectional study design was employed, involving 56 premenopausal participants with ages ranging from 20 to 49 years. Serum samples were collected during the early follicular phase, and levels of some biochemicals parameters analyzed. conditions: Menstrual Irregularity conditions: Menstrual Cycle Abnormal studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In the overall study population of 56 subjects recruited from, Sivas Cumhuriyet University Faculty of Medicine Research and Practice Hospital, Gynecology and Obstetrics Clinic, divided into two groups: irregular menstrual cycle (n=28) and regular menstrual cycle control group (n=28). While those who met the criteria for menstrual irregularity were included, those with another gynecological disease (PCOS, endometriosis, etc.) and additional diseases (diabetes, insulin resistance, cancer, heart disease, etc.) were excluded from the study. All participants provided written informed consent before participating in the study. Participants were asked to report the average length of their menstrual cycle over the past six months, as well as the consistency of cycle length. Menstrual regularity was assessed by self-report using a standardized questionnaire. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 56 type: ACTUAL name: Serum ADMA, MDA and M30 levels mesurment measure: ADMA, M30 and MDA levels mesurment in the blood serum to compare between patient and control. sex: FEMALE minimumAge: 20 Years maximumAge: 49 Years stdAges: ADULT facility: Sivas Cumhuriyet University Hospital city: Sivas state: Centre zip: 58050 country: Turkey lat: 39.74833 lon: 37.01611 hasResults: False
<\|newrecord\|> nctId: NCT06339463 id: AAAU7985 briefTitle: Self-Distancing for Pediatric Anxiety and OCD overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-01 date: 2024-04-01 name: Columbia University class: OTHER briefSummary: Self-Distancing is a cognitive technique that involves shifting perspective away from first person to promote an adaptive, self-reflective stance in emotionally charged situations. This trial aims to help learn how self-distancing may increase approach during exposure and thereby improve treatment response. To find out if self-distancing works by helping children approach fear inducing stimuli, the study will look at behaviors related to approach as well as symptom severity, before, after and during treatment.
The study hypothesizes that Self-Distancing will produce greater increases in approach behaviors and greater decreases in anxiety severity than in the Classic Exposure. conditions: Anxiety Disorders conditions: Obsessive-Compulsive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Youth will be randomized 10 weekly exposure therapy sessions with or without self-distancing. These conditions will run in parallel. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The rater will be blinded to which condition, self-distancing or classic exposure, child participants receive. whoMasked: OUTCOMES_ASSESSOR count: 35 type: ESTIMATED name: Self-Distancing (EXSD) name: Classic Exposure (EXC) measure: Treatment Engagement and Adherence Ratings (TEARS) measure: Anxiety Disorders Interview Schedule for DSM-5 (ADIS) Clinical Severity Rating (CSR) measure: Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) measure: Screen for Child Anxiety Related Disorders (SCARED)- Parent and Child measure: Obsessive-Compulsive Inventory - Child Version (OCI- CV) measure: Toronto Obsessive Compulsive Scale, Parent version (TOCS) measure: Clinical Global Impression of Severity (CGI-S) Scale measure: Clinical Global Impression of Improvement (CGI-I) Scale sex: ALL minimumAge: 7 Years maximumAge: 17 Years stdAges: CHILD facility: Columbia University Irving Medical Center city: New York state: New York zip: 10019 country: United States name: Sherry Chen role: CONTACT phone: 734-276-0443 email: yc4415@cumc.columbia.edu name: Rebecca Grossman, Ph.D. role: CONTACT phone: 734-276-0443 email: rg3347@cumc.columbia.edu name: Kate Fitzgerald, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
<\|newrecord\|> nctId: NCT06339450 id: ExpoCF briefTitle: Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects acronym: ExpoCF overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-07-01 date: 2027-12-31 date: 2024-04-01 date: 2024-04-01 name: Centre Hospitalier Intercommunal Creteil class: OTHER briefSummary: Cystic fibrosis (CF) is the most common autosomal recessive disease that leads to early mortality in Caucasians and affects around 7500 patients in France. Progression of the disease depends on pulmonary exacerbations defined as acute deterioration of respiratory symptoms which ultimately impair lung function and quality of life. Most frequently caused by lung bacterial infections, exacerbations' effects include increased cough, increased sputum production, increased use of antibiotics, dyspnea and decreased lung function. The phenotypic variability of CF suggests the implication of other contributors especially to the CF airway disease. Beside genetic and epigenetic alterations, environmental factors - e.g tobacco smoke, air pollution, temperature changes, food intake - appear as relevant candidates. A previous review has discussed current knowledge on the effects of air pollution on the course of CF disease. Although scarce, the existing epidemiological andexperimental literature suggests a link between exposure to air pollutants and adverse health effects.Although scarce, the existing epidemiological and experimental literature suggests a link between exposure to air pollutants and adverse health effects. The EU sponsored REMEDIA project (Impact of exposome on the course of lung diseases, Grant agreement ID 874753) contributes to the understanding of the influence of the exposome on chronic obstructive pulmonary disease (COPD) and CF. Objective of work package 3 within the REMEDIA project is the development of a mobile environmental sensor toolbox that is capable to assess the external exposome. The biomarkertoolbox was developed and tested in a proof-of-concept study carried out in healthy volunteers. The next step is to validate the collectionof exhaled breath condensate (EBC) in a real-life study. In this aim, the objective of the present study will be to assess the feasibility of EBC collection in CF patients and healthy individuals conditions: Cystic Fibrosis, Pulmonary conditions: Environmental Exposure conditions: Exhaled Breath Condansate studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 16 type: ESTIMATED name: walk tours measure: Collection of exhaled breath condensate (EBC) for biomarker analysis measure: Collection of exhaled breath condensate (EBC) for biomarker analysis measure: Collection of exhaled breath condensate (EBC) for biomarker analysis measure: Collection of exhaled breath condensate (EBC) for biomarker analysis measure: Collection of exhaled breath condensate (EBC) for biomarker analysis measure: Collection of exhaled breath condensate (EBC) for biomarker analysis measure: Dysfunction or misused, failure, of EBC and sensor device measure: Show correlation of biomarker signal with environmental sensor system in a clinical challenge setting in healthy and CF patients. measure: Describe differences in CF subjects vs. healthy controls measure: Impact of environment exposome on health status and lung function measure: Show correlation of biomarker signal with environmental sensor system in a clinical challenge setting in healthy and CF patients. measure: Describe differences in CF subjects vs. healthy controls sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06339437 id: Adeel3 briefTitle: Enhanced Recovery After Cholecystectomy overallStatus: COMPLETED date: 2023-04-01 date: 2023-10-30 date: 2023-11-01 date: 2024-04-01 date: 2024-04-12 name: Children Hospital and Institute of Child Health, Lahore class: OTHER briefSummary: this study will be conducted involving patients of all genders between the ages of 20 and 60 years who will undergo elective laparoscopic cholecystectomy for uncomplicated symptomatic gallstone disease. The study will be conducted in Department of West Surgical Ward, Mayo Hospital, Lahore, after receiving approval from the hospital's Ethical Committee. Patients having other co-morbid conditions, pregnant patients, and those undergoing laparoscopic cholecystectomy converted to open surgery will be excluded from the study. LFTs and other baseline investigations will be done routinely of every patient. Written informed consent will be obtained from all the patient. Patients will be divided into two groups with 30 patients in each group. Group A will consist of patient in whom ERAS protocol will be implemented and Group B in whom ERAS protocol will not be implemented. conditions: Cholelithiases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: ERAS protocols applied primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: outcomeassessor was not told about group allocation whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: ERAS Protocol measure: PONV measure: Visual Analogue Scale score sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: The Children Hospital city: Lahore state: Punjab zip: 42000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False
<\|newrecord\|> nctId: NCT06339424 id: 202400156A3 briefTitle: Atezolizumab and Bevacizumab With Photon Radiotherapy for Unresectable Hepatocellular Carcinoma acronym: PhotonAB overallStatus: NOT_YET_RECRUITING date: 2024-03-29 date: 2029-03-30 date: 2031-03-30 date: 2024-04-01 date: 2024-04-01 name: Chang Gung Memorial Hospital class: OTHER briefSummary: Atezolizumab (anti-programmed death-ligand 1; anti-PD-L1) in conjunction with bevacizumab (anti-vascular endothelial growth factor; anti-VEGF) has become the established standard first-line systemic treatment for unresectable hepatocellular carcinoma (HCC). Despite an improved objective response rate (ORR) of 27%, the majority of patients face HCC progression and liver failure \[Finn et al., N Engl J Med 2020\]. Developing a new combined treatment strategy to overcome resistance to anti-PD-L1 and anti-VEGF is essential to improve patient outcomes.
Radiation treatment (RT) is highly efficacious in controlling localized solid tumors and has become an integral component of the treatment algorithm for unresectable HCC. Importantly, a recent retrospective cohort described that RT combined with atezolizumab plus bevacizumab was associated with favorable median overall survival of 16.1 months (Manzar et al, Cancers 2022). Our preclinical study (Hsieh et al., Science Immunology 2022) revealed that RT combined with PD-L1/PD-1 blockade induces immunogenic cell death and tumor antigen cross-presentation in antigen-presenting cells, thereby potentiating the systemic antitumor T cell responses in murine tumor models. However, whether the combinatorial therapy with RT, atezolizumab, and bevacizumab can trigger synergistic antitumor effects and systemic immune mobilization has not yet been validated in clinical trials for unresectable HCC.
Both atezolizumab/bevacizumab and X-ray RT are approved treatment methods for unresectable HCC by the U.S. and Taiwan Food and Drug Administration (FDA). The present phase II non-randomized trial aims to prospectively document the therapeutic efficacy, safety, and immunological responses in patients with unresectable HCC treated with atezolizumab/bevacizumab combined with conventional photon radiotherapy. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Atezolizumab name: Bevacizumab name: Photon radiotherapy measure: Progression free survival (PFS) measure: Local control (LC) measure: Time to progression (TTP) measure: Overall Response Rate (ORR) measure: Overall survival (OS) measure: Incidence and severity of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chang Gung Memorial Hospital at Linkou city: Taoyuan City zip: 333 country: Taiwan lat: 24.95233 lon: 121.20193 hasResults: False
<\|newrecord\|> nctId: NCT06339411 id: 202302239A3 briefTitle: Exploring Cerebrolysin in Late Thrombectomy for Stroke: Blood-brain Barrier Biomarkers and Imaging Insights overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2027-07-31 date: 2024-04-01 date: 2024-04-02 name: Chang Gung Memorial Hospital class: OTHER briefSummary: Background:
Stroke is a leading cause of mortality and disability globally, with acute ischemic strokes(AIS) due to Large Vessel Occlusion (LVO) presenting significant treatment challenges. Mechanical thrombectomy (MT) has emerged as an effective intervention for AIS within an 8-hour window from symptom onset. However, the potential to extend this window up to 24 hours for select patients could revolutionize outcomes for those arriving late at comprehensive stroke centers. This study investigates the efficacy and safety of Cerebrolysin as an adjunct therapy to MT in extended time window and improving patient recovery.
Methods:
We conducted a multi-center, prospective, randomized study within the Chang Gung Memorial Hospital system in Taiwan, targeting 100 AIS patients eligible for MT beyond the traditional 8-hour window. Participants were randomized to receive either standard care or Cerebrolysin post-MT, initiated within 24 hours of stroke onset and continued for 14 days. The study assessed neurological, neuropsychological, and biomarker outcomes at multiple time points post-stroke to evaluate the effects of Cerebrolysin on recovery.
Results:

Subsets and Splits

No community queries yet

The top public SQL queries from the community will appear here once available.