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## Study to Assess PK, Safety and Tolerability Early in Healthy Subjects - NCT ID: NCT06388772 - Study ID: HJG-CZQH-QHRD106 - Status: COMPLETED - Start Date: 2021-07-05 - Completion Date: 2023-01-06 - Lead Sponsor: Changzhou Qianhong Bio-pharma Co., Ltd. ### Study Description The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of QHRD106 early in Chinese healthy subjects with single doses. ### Conditions - Acute Ischemic Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - QHRD106 Injection - placebo ### Outcomes Primary Outcomes - Safety as assessed by incidence, severity, and causality of adverse events - Plasma measurements of QHRD106 Secondary Outcomes ### Location - Facility: Nanjing Drum Tower Hospital, Nanjing, Jiangsu, 210008, China @@
## TQ05105 Tablet for Myelofibrosis Treatment in Ruxolitinib-Resistant or Intolerant Patients - NCT ID: NCT06388759 - Study ID: TQ05105-Ib-03 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-08-01 - Completion Date: 2024-12 - Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ### Study Description This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy of TQ05105 Tablets in patients with intermediate-risk and high-risk myelofibrosis. ### Conditions - Myelofibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - TQ05105 Tablets ### Outcomes Primary Outcomes - Spleen volume reduction (SVR35)≥35% from baseline Secondary Outcomes - Optimum effective rate - Onset time of splenic response - Duration of maintenance of spleen response (DoMSR) ≥35% reduction - Myeloproliferative neoplasm- Symptom Assessment Form- Total Symptom Score (MPN-SAF TSS) : ≥ 50% Reduction from Baseline - The total symptom score of MPN-SAF TSS decreased compared with baseline - Progression-free survival (PFS) - Leukemia free survival (LFS) - Overall Survival (OS) - Incidence of adverse events (AEs) - Severity of AEs ### Location - Facility: Anhui Provincial Hospital, Hefei, Anhui, 230001, China @@
## Arresting Carious Lesions With Minimal Intervention Techniques - NCT ID: NCT06388746 - Study ID: NKUA - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-12 - Lead Sponsor: National and Kapodistrian University of Athens ### Study Description A single-blinded randomized clinical trial with a split-mouth design that will assess the 12-month clinical and radiographic success of two minimally invasive treatment techniques, one using a chemo-mechanical caries removal agent and one using a caries arresting agent, for the treatment of deep caries in primary molars. ### Conditions - Caries,Dental ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - BRIX3000® - Riva Star Aqua, SDI Limited, Australia ### Outcomes Primary Outcomes - clinical success - radiographic success Secondary Outcomes - Longevity and the quality of the final restoration - Patient's acceptance ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma - NCT ID: NCT06388733 - Study ID: IVY P3-24-021 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2028-03 - Lead Sponsor: Ivy Brain Tumor Center ### Study Description The goal of this Phase 3 clinical trial is to compare the efficacy of niraparib versus temozolomide (TMZ) in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma multiforme (GBM). The main questions it aims to answer are:Does niraparib improve progression-free survival (PFS) compared to TMZ?Does niraparib improve overall survival (OS) compared to TMZ?Participants will be randomly assigned to one of two treatment arms: niraparib or TMZ.* study drug (Niraparib) or* comparator drug (Temozolomide - which is the standard approved treatment for MGMT unmethylated glioblastoma).The study medication will be taken daily while receiving standard of care radiation therapy (RT) for 6-7 weeks.Participants may continue to take the niraparib or TMZ adjuvantly as long as the cancer does not get worse or completion of 6 cycles of treatment (TMZ). A total of 450 participants will be enrolled in the study.Participants' tasks will include:* Complete study visits as scheduled* Complete a diary to record study medication ### Conditions - Glioblastoma - GBM - Brain Neoplasms, Adult, Malignant - Brain Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Niraparib - Temozolomide ### Outcomes Primary Outcomes - Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) - Overall survival Secondary Outcomes - Overall response rate - Compare symptoms, function, and Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-C30-item Core module (EORTC QLQ-C30) (Scores on a scale) - Compare symptoms, function, and Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-BN20-item Core module (EORTC QLQ-BN20) (Scores on a scale) - Changes from baseline in neurocognitive function assessed by Hopkins Verbal Learning Test - Changes from baseline in neurocognitive function assessed by Controlled Oral Word Association - Changes from baseline in neurocognitive function assessed by Trail Making Test Parts A and B - Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) - Number of treatment discontinuations, dose interruptions, and dose reductions due to AEs, SAEs, or AESIs, changes in Karnofsky performance status, changes in clinical laboratory results, and vital sign measurements - Frequency and severity of symptomatic AEs based on PRO-CTCAE ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy - NCT ID: NCT06388720 - Study ID: NCC2024-0026 - Status: RECRUITING - Start Date: 2024-04-30 - Completion Date: 2027-12-31 - Lead Sponsor: National Cancer Center, Korea ### Study Description The aim of this study is to evaluate the effectiveness and safety of mitomycin-c and gemcitabine sequential instillation in BCG unresponsive high risk non-muscle invasive bladder cancer patients. ### Conditions - Bladder Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml ### Outcomes Primary Outcomes - Recurrent free survival in sequential treatment group. Secondary Outcomes - Progression free survival in sequential treatment group. - Cystectomy free survival in sequential treatment group. - cancer specific survival in sequential treatment group. - Overall survival in sequential treatment group. - Safety of sequential treatment. ### Location - Facility: National Cancer Center, Goyang-si, N/A, N/A, Korea, Republic of @@
## A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy - NCT ID: NCT06388707 - Study ID: NF-2022-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2025-12-31 - Lead Sponsor: NaviFUS Corporation ### Study Description This will be a prospective, open-label, single-arm, multi-center, pilot study to evaluate the safety, tolerability, and preliminary efficacy of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy (DR-TLE). ### Conditions - Drug Resistant Epilepsy - Epilepsy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - NaviFUS System ### Outcomes Primary Outcomes - Adverse events (AEs) Secondary Outcomes - Change from baseline in seizure frequency - Change from baseline in electroencephalography (EEG) epileptiform discharges - Days of seizure-free - Changes from baseline in Beck Anxiety Inventory (BAI) - Changes from baseline in Beck Depression Inventory (BDI-II) - Changes from baseline in Personal Impact of Epilepsy Scale (PIES) ### Location - Facility: Stanford University School of Medicine, Palo Alto, California, 94305, United States @@
## Pharmacist Management of Attention Deficit Hyperactivity Disorder Medication Refill Requests - NCT ID: NCT06388694 - Study ID: RDO KPNC 24-056 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-02 - Completion Date: 2024-07-31 - Lead Sponsor: Kaiser Permanente ### Study Description This cluster randomized trial will compare pharmacist management of secure message requests for refills of attention deficit hyperactivity medications with primary care physician management regarding quality of care, timeliness of service, and parent care experience. ### Conditions - Attention-deficit Hyperactivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Pharmacist Care - Primary Care Physician Care ### Outcomes Primary Outcomes - Percentage of participants appropriately referred for a follow-up weight check Secondary Outcomes - Timeliness of care - Parent perception of effectiveness of care ### Location - Facility: Kaiser Permanente Northern California, Oakland, California, 94612, United States @@
## Stress Ball Use in Patients Undergoing Coronary Angiography - NCT ID: NCT06388681 - Study ID: HMKU-KMY-SA-02 - Status: RECRUITING - Start Date: 2024-04-24 - Completion Date: 2024-06-26 - Lead Sponsor: Mustafa Kemal University ### Study Description One of the nonpharmacologic interventions included in the NIC-Nursing Interventions Classification is the use of stress balls. Stress balls are one of the cognitive distraction methods used especially in reducing pain and increasing the comfort level of patients. On the other hand, there are studies showing that stress balls have a positive effect not only on pain but also on vital signs, anxiety and comfort level of the patient. ### Conditions - Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - The Effect of Stress Ball Use on Immobilization Comfort, Pain Level and Vital Signs in Patients Undergoing Coronary Angiography ### Outcomes Primary Outcomes - Patient Identifying Information Form - Immobilization Comfort Scale Secondary Outcomes ### Location - Facility: Hatay Mustafa Kemal University, Hatay, N/A, N/A, Turkey @@
## Lipid Testing After Myocardial Infarction at the Montreal Heart Institute - NCT ID: NCT06388668 - Study ID: ICM 2025-3428 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-09 - Lead Sponsor: Montreal Heart Institute ### Study Description Because treatment decisions are usually based on a single measurement of the lipid panel at the time of an admission for an MI, the overarching objective of this project is to evaluate whether the measurement of LDL, non-HDL, and apoB values are reliable through all the duration of the hospitalization.It will be a single-center, prospective, observational study will be conducted, including consecutive patients hospitalized for myocardial infarction at the Montreal Heart Institute.Every patient at the Cardiac Care Unit will undergo non-fasting lipid panel testing at day 0 of their admission for Myocardial Infarction during the study period. Patients who consent to participate will have a 2nd non-fasting lipid panel drawn at day 2 of their admission.Thereafter, the levels of the different lipid values from the panel will be compared between day 0, day 2, and 4-6 weeks after discharge. ### Conditions - Dyslipidemias - Lipid Testing - Myocardial Infarction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Lipid panel ### Outcomes Primary Outcomes - Variation in LDL Secondary Outcomes - Variation in non-HDL and apoB - Evaluation of intensification threshold ### Location - Facility: Montreal Heart Institute, Montréal, Quebec, H1T 1C8, Canada @@
## The Effect of the Mobile EEG-Neurofeedback in Healthy Child and Adolescent - NCT ID: NCT06388655 - Study ID: MDCR-19-007 - Status: COMPLETED - Start Date: 2019-06-10 - Completion Date: 2022-06-30 - Lead Sponsor: Daegu Catholic University Medical Center ### Study Description The objective of this study was to ascertain the therapeutic impact of mobile neurofeedback (MNF) in neurotypical children when compared to sham MNF. Clinical assessments were conducted both before and after the MNF intervention, and the effectiveness of the intervention was to be validated through these evaluations. ### Conditions - Internet Addiction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - mobile neurofeedback - sham mobile neurofeedback ### Outcomes Primary Outcomes - Comparisons of the means of children's self-scale variables Secondary Outcomes - Comparisons of the means of parents' self-scale variables : Beck Depression Inventory-II (BDI-II) - Comparisons of the means of parents' self-scale variables : Beck Anxiety Inventory (BAI) - Comparisons of the means of children's K-WISC-IV(Korean Wechsler Intelligence Scale for Children-IV) - Comparisons of the means of children's Stroop - Comparisons of the means of children's ATA(Advanced Test of Attention) - Comparisons of the means of children's CCTT(Children's Color Trails Test) ### Location - Facility: Daegu Catholic University Medical Center, Daegu, Nam-gu, 42471, Korea, Republic of @@
## Pharmacokinetics of Afamelanotide in EPP Patients - NCT ID: NCT06388642 - Study ID: CUV052 - Status: RECRUITING - Start Date: 2024-03-07 - Completion Date: 2024-10-01 - Lead Sponsor: Clinuvel Europe Limited ### Study Description The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients. ### Conditions - Erythropoietic Protoporphyria ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Afamelanotide 16mg implant ### Outcomes Primary Outcomes - Cmax (maximum Plasma Concentration) - AUC(0-t) (area under the curve from administration to last observed concentration at time t) Secondary Outcomes - AUC(0-∞) (area under the curve extrapolated to infinite time) ### Location - Facility: Erasmus Medical Center, Rotterdam, N/A, N/A, Netherlands @@
## Epicardial Access Study With Rook - NCT ID: NCT06388629 - Study ID: M064-066 Rev 00 - Status: RECRUITING - Start Date: 2023-12-17 - Completion Date: 2024-05 - Lead Sponsor: Circa Scientific, Inc. ### Study Description The goal of this clinical trial is to test how how effective the Circa Scientific Rook® Epicardial Access Kit is at gaining guidewire access to the outside surface of the heart (epicardium). In addition the safety of the device will be compared to the available data for alternative methods of epicardial access.Participants will receive treatment with the subject device during the course of a typical epicardial electrophysiology procedure. ### Conditions - Arrythmia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Rook Epicardial Access Kit ### Outcomes Primary Outcomes - Successful Epicardial Access Secondary Outcomes - Speed of Access - Rate of Use Errors ### Location - Facility: Na Homolce Hospital, Prague, N/A, 15030, Czechia @@
## Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone - NCT ID: NCT06388616 - Study ID: D6402C00013 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-02 - Completion Date: 2024-11-15 - Lead Sponsor: AstraZeneca ### Study Description This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of balcinrenone in patients with mild and moderate hepatic impairment in comparison to a matched healthy control group. ### Conditions - Hepatic Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Balcinrenone ### Outcomes Primary Outcomes - Area under plasma concentration-time curve from time zero to the last measurable concentration (AUClast) - Area under plasma concentration-time curve from zero to infinity (AUCinf) - Maximum observed plasma concentration (Cmax) Secondary Outcomes - AEs and SAEs up to the follow-up telephone call (Day 10 [± 3 days]) - Number of participants with abnormal Vital signs, abnormal ECGs, and abnormal physical examination findings - Number of participants with abnormal laboratory tests results ### Location - Facility: Research Site, Hialeah, Florida, 33014, United States @@
## RCT on Bioactive Glass S53P4 in Diabetic Foot Osteomyelitis in the Forefoot (DFORCT) - NCT ID: NCT06388603 - Study ID: DFORCT012023 - Status: RECRUITING - Start Date: 2024-03-21 - Completion Date: 2026-12-30 - Lead Sponsor: ASST Ovest Milanese ### Study Description The Study will be a prospective multicenter randomized trial, focused on the management of acute and chronic Osteomilytis in Diabetic Foot patients. The aim of this Study will be to compare the effectiveness and safety of S53P4 bioactive glass, medical device class III used as per its CE mark indication and Instruction For Use, in the surgical management of OM in the forefoot performed as per local surgical standard of care, in the same indications in a group of Diabetic Foot patients admitted in highly specialized dedicated centers.Participants will randomized into two groups:* Patients in Group A will be treated with surgical removal of the affected bone, debridement of infected soft tissues and systemic antibiotic therapy targeted on the sampling on the bone during the surgical procedure, with or without use of bone substitutes (with the only exception of Bioactive glasses) according to the judgement of the operator as per normal practice.* Patients in Group B will be debrided as well and the infected bone will be debrided without eliminating completely the structure of the bone, but instead preserving the cortex, while all the soft bone visibly infected will be removed and then replaced with Bioactive glass, as per IFU, (S53P4 - Bonalive® granules and putty, Bonalive Biomaterials Ltd. Finland) and then closed for primary intention whenever possible. ### Conditions - Osteomyelitis - Foot ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bioactive Glass - Standard of Care ### Outcomes Primary Outcomes - healing rate Secondary Outcomes - Duration of antibiotic therapy - Rate of recurrences - Number of re-interventions because of the same lesion - Timing of re-interventions because of the same lesion - Proportion of patients undergoing amputations - Patients' Quality of Life - Patients' Quality of Life - Time back to walk - Characteristics of surgery - Length of surgery ### Location - Facility: ASUGI Azienda Sanitaria Universitaria Giuliano Isontina - Ospedale Monfalcone, Monfalcone, Gorizia, 34074, Italy @@
## Acupuncture for Chronic Pelvic Pain - NCT ID: NCT06388590 - Study ID: MOMMC.2024.0029 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: David Moss ### Study Description The objective of this study is to determine if alternative pain management strategies, namely acupuncture, may help reduce intensity of female pelvic pain compared to other pain control modalities. This research study will focus specifically on the Dragon's protocol of acupuncture which will seek to alleviate chronic non-endometriosis pelvic pain for women both with and without a history of sexual assault.This study may support evidence for an inexpensive alternative means of treatment for patients with or without traumatic sexual history and chronic pelvic pain. ### Conditions - Pelvic Pain - Acupuncture - Gynecology ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Dragons - Standard of Care ### Outcomes Primary Outcomes - Defense and Veterans Pain Rating Scale (DVPRS) - Defense and Veterans Pain Rating Scale (DVPRS) - Defense and Veterans Pain Rating Scale (DVPRS) - Defense and Veterans Pain Rating Scale (DVPRS) - Defense and Veterans Pain Rating Scale (DVPRS) - Defense and Veterans Pain Rating Scale (DVPRS) - Female Genitourinary Pain Index (GUPI) - Female Genitourinary Pain Index (GUPI) - Female Genitourinary Pain Index (GUPI) - Female Genitourinary Pain Index (GUPI) - Female Genitourinary Pain Index (GUPI) - Female Genitourinary Pain Index (GUPI) Secondary Outcomes - PTSD Checklist for DSM-5 (PCL-5) - PTSD Checklist for DSM-5 (PCL-5) - PTSD Checklist for DSM-5 (PCL-5) - PTSD Checklist for DSM-5 (PCL-5) - PTSD Checklist for DSM-5 (PCL-5) - PTSD Checklist for DSM-5 (PCL-5) ### Location - Facility: Mike O'Callaghan Military Medical Center, Nellis Air Force Base, Nevada, 89191, United States @@
## The Effect of the Training Programme Based on the Health Promotion Model Given to Parents - NCT ID: NCT06388577 - Study ID: MEU-HEM-SY-189 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-13 - Completion Date: 2024-09-13 - Lead Sponsor: Mersin University ### Study Description This randomised controlled study evaluates the effect of a training programme based on the Health Promotion Model developed for parents of children diagnosed with epilepsy on parents' level of knowledge about epilepsy, parents' general self-efficacy level, parents' health promoting and protective behaviours and the number of hospital admissions of their children. The hypothesis of this study is that education has an effect on these. ### Conditions - Parents - Epilepsy in Children - Disease Management ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Education ### Outcomes Primary Outcomes - Parents' level of knowledge about epilepsy evaluated using the Form for the Evaluation of Parents' Level of Knowledge about Epilepsy - Self-efficacy evaluated using the General Self-Efficacy Scale - Health Promoting and Protective Behaviors evaluated using the Health Promoting and Protective Behaviors Scale Secondary Outcomes - Number of Hospital Admissions for Children evaluated using the Evaluation Form for the Number of Hospital Admissions ### Location - Facility: Turkey, Mersin University, Mersin, N/A, N/A, Turkey @@
## A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease - NCT ID: NCT06388564 - Study ID: INCA34176-254 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-08 - Completion Date: 2028-09-05 - Lead Sponsor: Incyte Corporation ### Study Description This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD. ### Conditions - Chronic Graft-versus-host-disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Axatilimab - Ruxolitinib - Corticosteroids ### Outcomes Primary Outcomes - Objective Response Rate Secondary Outcomes - Number of participants with Treatment-emergent Adverse Events (TEAEs) - Duration of Response - Proportion of participants with a ≥ 7-point improvement in modified Lee symptom scale (mLSS) score - Best overall response in the first 6 months - OR at 12 months, defined as CR or PR at 12 months (C14D1) in the absence of new systemic therapy for cGVHD. - Proportion of participants who remain corticosteroid-free - Organ-specific response in the first 6 cycles and on study, based on the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD. - Failure-free Survival (FFS) - Axatilimab pharmacokinetic (PK) in Plasma - Ruxolitinib PK in Plasma ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Phase 1, SAD Study to Evaluate the Safety and Tolerability of LY03017 - NCT ID: NCT06388551 - Study ID: LY03017/CT-CHN-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-10 - Completion Date: 2025-03-30 - Lead Sponsor: Luye Pharma Group Ltd. ### Study Description This is a phase 1，randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and pharmacokinetics of oral LPM526000133 Fumarate Capsules (LY03017) in healthy adult subjects. ### Conditions - Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis - Hallucinations and Delusions Associated With Parkinson Disease Psychosis - Negative Symptoms of Schizophrenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - LY03017 - LY03017-Placebo ### Outcomes Primary Outcomes - Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) Secondary Outcomes - Maximum observed concentration (Cmax) of LPM526000133 in plasma - Time to maximum observed concentration (Tmax) of LPM526000133 in plasma - The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM526000133 in plasma - Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of LPM526000133 in plasma - Apparent terminal elimination half-life (t1/2) of LPM526000133 in plasma ### Location - Facility: Shanghai Mental Health Center, Shanghai, N/A, N/A, China @@
## The COLD2B Multicenter, Two-arm Prospective Cohort Study - NCT ID: NCT06388538 - Study ID: Carlo Bergamini - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-06-01 - Lead Sponsor: Azienda Sanitaria di Firenze ### Study Description Since it is still debated whether 2b acute diverticulitis (AD), according to the World Society of Emergency Surgery (WSES) classification, should be initially treated surgically or conservatively, we launched the COLD2B study to compare the clinical results of both therapeutic regimens in a multi-institutional cohort of prospectively enrolled patients.The primary aim of the COLD2B (Conservative vs surgical (either Open or Laparoscopic) approach in the emergency management of acute Diverticulitis WSES 2B) study is to develop a model able to predict the length of hospitalization, comparing the management of WSES 2b AD in the emergency setting (conservative versus surgical approach) (primary endpoint of the first arm of the study).Moreover, the two groups will be compared regarding mortality and morbidity (secondary end-point).The second arm of the study will consider the population undergoing surgery, develop a model able to predict the length of hospitalization, and compare the open vs laparoscopic approach (primary end-point), and mortality, morbidity, and surgical outcome indices (secondary end-point). ### Conditions - Acute Diverticulitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Conservative treatment (non-operative treatment) - Surgical treatment (operative treatment) ### Outcomes Primary Outcomes - Length of hospital stay in the overall population Secondary Outcomes - Morbidity rate for both arms - Mortality rate for both arms - Surgical complications rate ### Location - Facility: Dipartimento di Medicina di Precisione e Rigenerativa e Area Jonica (DiMePRe-J), Universita' di Bari, Bari, N/A, N/A, Italy @@
## Post-ERCP Cholecystectomy. How ERCP and ERCP-related Variables Effect the Outcomes? - NCT ID: NCT06388525 - Study ID: PostERCPLC - Status: COMPLETED - Start Date: 2016-01-01 - Completion Date: 2020-01-01 - Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital ### Study Description In this retrospective study, we aimed to detect of effects of ERCP on outcomes of Laparoscopic Cholecystectomy. Patients underwent elective cholecystectomy surgery with a diagnosis of symptomatic cholelithiasis were identified and divided into two main groups regarding to have a ERCP procedure prior to surgery or not. To eliminate possible differences in baseline characteristics, patients in ERCP and non-ERCP groups were propensity score-matched 1:1 using nearest-neighbor matching without replacement based on age, sex and ASA score. Following propensity score matching (PSM), the ERCP and non-ERCP groups were first compared to detect effects of the ERCP procedure itself. After comparison of two main groups, subgroup analyzes performed for the ERCP group to detect effect of ERCP-related variables (indication for ERCP procedure, time between last ERCP procedure and surgery, number of preoperative ERCPs, stone extractions, and biliary stent use) ### Conditions - Endoscopic Retrograde Cholangiopancreatography - ERCP-Laparoscopic Cholecystectomy Interval - Number of Preoperative ERCPs - Stone Extraction Status in ERCP Procedures - Biliary Stents - Mechanical Lithotripsy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Endoscopic Retrograde Cholangiopancreatography ### Outcomes Primary Outcomes - Conversion to open - Subtotal Cholecystectomy - Postoperative Complications - Adhesion levels - Operative time - Length of hospital stay Secondary Outcomes ### Location - Facility: Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, N/A, N/A, Turkey @@
## iMRI Prone Positioning Frame Design Feasibility Study - NCT ID: NCT06388512 - Study ID: STUDY00160044 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: University of Kansas Medical Center ### Study Description The goal of this study is to learn if the prototype adjustable prone positioning frame is a feasible design for use during neurosurgical procedures which utilize intraoperative magnetic resonance imaging (iMRI). The main questions it aims to answer are:* Is the prototype prone positioning device design feasible for use during neurosurgical procedures which utilize intraoperative MRI?* Does use of the prototype device place the patient at increased risk of complications compared to the standard positioning pads? Researchers will place patients in the prone position on the prototype device during neurosurgical procedures that utilize intraoperative MRI and observe for any problems with the positioning device or complications attributable to the positioning device. ### Conditions - Epilepsy - Pulmonary Embolism ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - prototype prone positioning device ### Outcomes Primary Outcomes - Number of devices that meet functional requirements - Number of devices that are damaged during use Secondary Outcomes - Number of patients with skin complications - Number of patients with thromboembolic complications ### Location - Facility: University of Kansas Medical Center, Kansas City, Kansas, 66160, United States @@
## A Physiotherapy-led Disease-agnostic Telerehabilitation Programme for People With Chronic Health Conditions - NCT ID: NCT06388499 - Study ID: GOIPG/2022/1854 - Status: RECRUITING - Start Date: 2024-04-16 - Completion Date: 2024-07-31 - Lead Sponsor: University of Limerick ### Study Description This protocol outlines a planned mixed methods feasibility trial which will be conducted to examine the feasibility and acceptability of a physiotherapy-led exercise-based telerehabilitation programme for groups of people with mixed chronic health conditions. ### Conditions - Chronic Conditions, Multiple ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - TECC (Telerehabilitation and Exercise for Chronic Conditions) ### Outcomes Primary Outcomes - Recruitment rate assessed by number of participants recruited during recruitment period. - Retention rate assessed by the proportion of enrolled participants who complete post-intervention assessments. - Adherence rate assessed by the attendance at synchronous group exercise sessions - Satisfaction with the intervention as assessed by the Client-Satisfaction Questionnaire 8 (CSQ-8) - Satisfaction with individual intervention components assessed by Numerical Rating Scales (NRS) - Adverse events assessed via self-report questionnaire - Intervention acceptability as assessed by qualitative feedback from participants via focus groups Secondary Outcomes - Physical function assessed by the 30-second chair stand test (30CST). - Quality of life assessed by the Euro-QoL 5 Dimension 5 Level (Euro-QoL-5D-5L). ### Location - Facility: South Tipperary Chronic Disease Management Hub, St. Brigid's Hospital, Carrick-on-Suir, Tipperary, N/A, N/A, Ireland @@
## Cytokine-Induced Transcription in Depressed Inpatients Undergoing Psychotherapy - NCT ID: NCT06388486 - Study ID: UMCGoettingen9/9/16 - Status: COMPLETED - Start Date: 2017-01-01 - Completion Date: 2024-01-01 - Lead Sponsor: University Medical Center Goettingen ### Study Description The goal of this observational study is to measure the levels of cytokine-induced transcription factor activation in a cohort of depressed inpatients undergoing psychotherapy. The study aims to answer the following main questions:* Do psychological traits (i.e.: social inhibition, negative affectivity, ...) affect the activation of immunomodulatory transcription factors (STAT3, NFkB) in depressed patients?* Are subjects with these psychological traits affected differently by psychotherapeutic intervention?Study subjects are assessed for their psychological and behavioral traits and receive psychotherapeutic care over several weeks during hospital treatment. Peripheral blood mononuclear cells are isolated from the study subjects, and activation of transcription factors is measured by flow cytometry. ### Conditions - Depression ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Psychotherapy ### Outcomes Primary Outcomes - Change in depression Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Implementation of a Web-based App for Screening in Men in a Malaysian Primary Care Setting - NCT ID: NCT06388473 - Study ID: NMRR-20-2188-56086 IIR - Status: COMPLETED - Start Date: 2021-01-14 - Completion Date: 2021-06-06 - Lead Sponsor: University of Malaya ### Study Description The purpose of this study is to determine how to successfully implement ScreenMen in the primary care setting. ScreenMen is a mobile web-based app that has been developed to increase the uptake of screening in men. ScreenMen undertook a vigorous and systematic approach in its development. It was developed based on theories, evidence and needs of men. ScreenMen particularly target men in the age group of 20 to 50 years as this group of men usually do not attend any health screening. This research is necessary because ScreenMen has yet to be implemented in the primary care setting. The study will last about five months and your participation will be about five months. ### Conditions - Men's Health Screening - Implementation - Web-based Application ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Tailored implementation intervention ### Outcomes Primary Outcomes - Reach - Reach - Adoption of ScreenMen using qualitative methods - Implementation of ScreenMen using qualitative methods - Maintenance of ScreenMen using qualitative methods Secondary Outcomes - Impact of COVID-19 on the clinic using qualitative methods ### Location - Facility: Klinik Kesihatan Cheras Baru, Kuala Lumpur, N/A, 56100, Malaysia @@
## Asthma Link Effectiveness Trial: Cluster Randomized Controlled Trial - NCT ID: NCT06388460 - Study ID: STUDY00001015 - Status: RECRUITING - Start Date: 2024-04-04 - Completion Date: 2028-04 - Lead Sponsor: University of Massachusetts, Worcester ### Study Description The goal of this cluster RCT is to determine the effectiveness of Asthma Link, a school supervised asthma therapy program, compared with an educational asthma workbook, in improving asthma symptoms for children with poorly controlled asthma aged 5-14. ### Conditions - Childhood Asthma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Asthma Link - Enhanced Usual Care ### Outcomes Primary Outcomes - Improving Asthma Symptoms Secondary Outcomes - Improving Medication Adherence - Improving Healthcare Utilization - Reducing Parental Lost Workdays - Reducing School Absences - Improving Quality of Life ### Location - Facility: University of Massachusetts Chan Medical School, Worcester, Massachusetts, 01655, United States @@
## Reconstruction of Deficient Interdental Papilla Using Stem Cells vs Physiological Saline: a RCT - NCT ID: NCT06388447 - Study ID: UCMSC1 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-12-01 - Completion Date: 2025-03-30 - Lead Sponsor: University of Malaya ### Study Description The goal of this study is to assess the reconstruction of interdental papilla following the injection of UC-MSCs or physiological saline in patients with interdental papilla deficiency. Participants will be randomised into 2 groups (intervention vs placebo) to receive the treatment. ### Conditions - Gingival Recession, Localized ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Umbilical cord-mesenchymal stem cells ### Outcomes Primary Outcomes - Reconstruction of the deficient interdental papilla with soft tissue - Reconstruction of the deficient interdental papilla with bone - Reconstruction of the deficient interdental papilla with bone Secondary Outcomes ### Location - Facility: Orthodontic Postgraduate Clinic, Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, 50603, Malaysia @@
## Protective Arm Balance Responses - NCT ID: NCT06388434 - Study ID: HP-00100309 - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-08 - Lead Sponsor: University of Maryland, Baltimore ### Study Description The overall objective of this study is to investigate the effect of attention control training on reach-grasp stabilizing responses during fall-induced perturbations. The central hypothesis is that training attention control during reach to grasp balance perturbations will lead to increased grasp accuracies and reduced in-task falls. This research will mark the first explore the effects of training attention control on protective arm responses and fall rate during a balance perturbation paradigm and the first feasibility testing of a fully integrated cognitive and physical rehabilitation paradigm, moving beyond correlative designs and parallel treatments. The overall public health significance of the proposed research is that with improved protective arm responses and grasp accuracies, a larger randomized control study may be designed to mitigate falls among community dwelling older adults.Participants will be involved in 6 sessions. Session 1 will include the assessment, questionnaires, and training. Session 2 will include just the training. Session 3 will include the assessment and training. Sessions 4-5 will include just the training. Session 6 will include the assessment, questionnaires, and training. ### Conditions - Old Age; Debility - Peripheral Neuropathy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - Protective Arm Balance Response Training ### Outcomes Primary Outcomes - Grasp Accuracy - In-task falls incidence Secondary Outcomes - Electromyography (EMG) of the shoulder muscles - Physiological responses (heart rate variability) - Physiological responses (electrodermal activity) - Activity specific balance confidence scale - Stait Trait Anxiety Inventory - Subjective Units of Distress Scale - Mini Mental State Examination (MMSE) - Beck Anxiety Inventory - Somatosensation ### Location - Facility: Allied Health Research Building, Baltimore, Maryland, 21201, United States @@
## DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) - NCT ID: NCT06388421 - Study ID: GMS-PH-401 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2030-11-30 - Lead Sponsor: United Therapeutics ### Study Description This is a prospective, non-interventional, multicenter, registry of patients with pulmonary associated with interstitial lung disease (PH-ILD). ### Conditions - Pulmonary Hypertension Due to Lung Diseases and Hypoxia - Pulmonary Hypertension - Interstitial Lung Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Prospective study assessments ### Outcomes Primary Outcomes - Baseline characteristics as described by demographics, medical history, ILD history, PH history, family history (comorbidities), and diagnostic right heart catheterization values Secondary Outcomes - Changes in clinical features relating to patients' interstitial lung disease and pulmonary hypertension ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Sufentanil Target Controlled Infusion on Patient State Index Values and Electroencephalographic Spectrum During Total Intravenous Anesthesia With Propofol - NCT ID: NCT06388408 - Study ID: SufMAST - Status: NOT_YET_RECRUITING - Start Date: 2024-05-05 - Completion Date: 2024-09-30 - Lead Sponsor: University of Padova ### Study Description Sufentanil Target Controlled infusion (TCI, Gepts model) effects on Neuromonitoring during Total Intravenous Anesthesia (TIVA) with Propofol TCI (Eleveld model) has not been investigate yet.Authors aim to investigate its effect on Patient State index (PSi), the power spectrum EEG, the Analgesia Nociception Index (ANI) nad pupillometry values during maintenance durin TIVA-TCI with Propofol and Sufentanil. ### Conditions - Anesthesia Brain Monitor - Sufentanil - Target Controlled Infusion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Effects of Sufentanil on Patient State index (PSi) during stable Propofol general anesthesia - Effects of Sufentanil on Electroencephalogram (EEG) power spectrum during stable Propofol general anesthesia - Effects of Sufentanil on Analgesia Nociception Index (ANI) during stable Propofol general anesthesia Secondary Outcomes - Analgesia Nociception Index (ANI) values and postoperative pain - Patient State Index (PSi) values and postoperative delirium - Analgesia Nociception Index (ANi) values and postoperative delirium ### Location - Facility: Treviso Regional Hospital, Treviso, TV, 31100, Italy @@
## Clinical Performance of All-on-4 PEEK and Conventional Prostheses - NCT ID: NCT06388395 - Study ID: REC-23-05-12-02-F - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-08-30 - Lead Sponsor: University of Sharjah ### Study Description The all-on-4 treatment approach for completely edentulous mandible is a proven concept. However, there are still issues regarding the use of metal substructure to support the prostheses such as allergy, metallic taste, and aesthetic. Therefore, other materials such as polyetheretherketone (PEEK) are being tested for its suitability and is showing good potential. However, available evidence is limited regarding its clinical performance. Thus, the aim of this study is to compare clinical performance of all-on-4 treatment concept utilizing PEEK versus conventional metal framework as substructure in fully edentulous mandible. Thirty suitable patients will receive either PEEK or conventional all-on-4 prostheses for fully edentulous mandible. The prostheses will be retained by four implants utilizing the all-on-4 principle. Clinical performance will be assessed during the follow up period of up 3 years concerning screw loosening, material chipping or fracture, wear or staining, prosthesis survival and success, implant survival and success. ### Conditions - Failure, Prosthesis - Dental Prosthesis, Implant-Supported - Survival, Prosthesis - Complete Edentulism - Complication;Prostheses ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Accuracy of full-arch surgical guides - Survival and complications of the prostheses - Survival and complications of the implants - Conventional (metal-resin) implant-supported prosthesis - PEEK implant-supported prosthesis ### Outcomes Primary Outcomes - Accuracy of full-arch surgical guides - Survival rate of implants - Success rates of the Prostheses - Pain level Secondary Outcomes - Marginal bone loss - Plaque index - Pocket depth - Bleeding index ### Location - Facility: University of Sharjah, Sharjah, N/A, 7724, United Arab Emirates @@
## Investigation of the Audible ICD Alert Tone - NCT ID: NCT06388382 - Study ID: UKKx2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2025-05-30 - Lead Sponsor: Universitätsklinikum Köln ### Study Description Ability of ICD patients to hear the audible ICD alert is being assessed. ### Conditions - Implantable Defibrillator User ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Alert tone demonstration ### Outcomes Primary Outcomes - Alert tone audible Secondary Outcomes ### Location - Facility: University Hospital Cologne, Cologne, N/A, 50937, Germany @@
## Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer - NCT ID: NCT06388369 - Study ID: CA184-608 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-09 - Lead Sponsor: University Hospital, Essen ### Study Description A randomized, open-label Phase I/II study of neoadjuvant treatment with \[177Lu\]Lu-PSMA-617 radioligandtherapy (LuPSMA) with or without Ipilimumab in participants with very high-risk prostate cancer who are candidates for Radical Prostatectomy. ### Conditions - Very High Risk Prostate Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - [177Lu]Lu-PSMA-617 - Ipilimumab ### Outcomes Primary Outcomes - Feasibility to perform prostatectomy on time - Clinical activity: Proportion of participants in the full analysis set who achieve a pCR Secondary Outcomes - Safety Profile of neoadjuvant treatment before radical prostatectomy - Safety Profile of neoadjuvant treatment before radical prostatectomy ### Location - Facility: University Hospital Essen, Clinic of Urology, Essen, N/A, 45147, Germany @@
## Patient's Informational Privacy in Prehospital Emergency Care - Educational Intervention Study for the Paramedics - NCT ID: NCT06388356 - Study ID: 042024 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-25 - Completion Date: 2024-06-16 - Lead Sponsor: Eini Koskimies ### Study Description The main goal of this educational intervention study about patient's informational privacy (IP) is to evaluate the effect of the educational intervention into the paramedics' knowledge and attitude regarding patient's IP. The study also investigates the usability and the feasibility of the educational intervention.The main questions it aims to answer are:1. What is the effect of the educational intervention on the 1. theoretical knowledge of paramedics' regarding IP? 2. the paramedics' attitude towards patient's IP?2. What is the usability and feasibility of the intervention being evaluated according to the respondents? ### Conditions - Knowledge - Attitude of Health Personnel ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Educational intervention - Yksityisyyttä ensihoitoon / Informational privacy for preospital emergency care ### Outcomes Primary Outcomes - Paramedics' knowledge about patient's informational privacy Secondary Outcomes - paramedics' attitude towards patient's informational privacy. ### Location - Facility: University of Turku, Turku, N/A, 20520, Finland @@
## Causes of Listening Difficulties in Children - NCT ID: NCT06388343 - Study ID: S68485 - Status: NOT_YET_RECRUITING - Start Date: 2025-01 - Completion Date: 2027-12 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description Many children experience listening and processing difficulties (LiD), especially in background noise, despite normal hearing sensitivity. The prevalence of these problems is estimated at 0.5-1% in the general population. Listening difficulties are associated with developmental disorders (DD) such as specific language disorders, autism spectrum disorder (ASD), ADHD and learning disabilities. Many children with developmental problems are easily distracted by sounds, have difficulty concentrating for long periods, processing language, remembering and summarizing oral information, and can experience academic difficulties (reading, writing). Early identification, differential diagnosis and intervention are important to help children overcome these difficulties and reach their full potential. Some concerns about these listening and processing problems, such as the lack of a gold standard to diagnose LiD and age-appropriate reference data, led to the initiation of this study.CLINIC aims to develop a new approach to diagnose the causes of listening difficulties in children. This is accomplished through (1) a validated parent questionnaire and (2) a multidisciplinary behavioral assessment tool. Data from these combined measures will lead to evidence-based profiles of children with LiD, which in turn will help streamline their referral pathways and care pathways. ### Conditions - Listening Difficulties ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Evaluation of Children's Listening and Processing Skills - Multidisciplinary behavioral assessment ### Outcomes Primary Outcomes - ECLiPS questionnaire - Behavioral measures Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms - NCT ID: NCT06388330 - Study ID: s61692 - Status: COMPLETED - Start Date: 2019-04-26 - Completion Date: 2022-03-08 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description In this study, the investigators will evaluate the FODMAP diet as an alternative treatment for functional dyspepsia and explore its effect on different aspects of the pathophysiology of FD. ### Conditions - Functional Dyspepsia - FODMAP Diet ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - low FODMAP diet ### Outcomes Primary Outcomes - Improvement on gastrointestinal symptoms Secondary Outcomes - Reintroduction period - Evaluation of the low FODMAP diet on IBS related symptoms - Evaluation of the low FODMAP diet on symptom response and quality of life - Evaluation of the low FODMAP diet on depression, somatization - Evaluation of the low FODMAP diet on duodenal barrier function - Evaluation of the low FODMAP diet on gastric emptying - Evaluation of the low FODMAP diet on gastric accommodation ### Location - Facility: KU Leuven, Leuven, Vlaams-Brabant, 3000, Belgium @@
## Machine-based Algorithm for Increased Physical Activity and Sustained User Engagement - NCT ID: NCT06388317 - Study ID: 123632 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-01-01 - Completion Date: 2025-02-01 - Lead Sponsor: Western University, Canada ### Study Description This 12-week study compares the effectiveness of personalized daily step goals generated by a machine learning algorithm in the Sprout app versus fixed daily step goals of 10,000 steps among adults. Participants will be recruited through the Sprout app, and after a 1-week run-in period, they will be assigned to either the intervention or control group. The intervention group will receive adaptive goals based on their historical step data, while the control group will have a fixed goal. Both groups will receive financial incentives. This study aims to inform future interventions measuring changes in daily steps and app engagement levels (i.e., time spent on app, number of app opens) by studying how using financial incentives and an adaptive goal-setting design can improve physical activity levels of app users, informed by a machine learning algorithm. ### Conditions - Health Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Adaptive Step Goal (Intervention) - Static Step Goal (Control) ### Outcomes Primary Outcomes - Step count Secondary Outcomes - Number of app opens, total time spent on app, number of pages opened ### Location - Facility: Western University, London, Ontario, N/A, Canada @@
## THRIVE Study: Positive Affect Training for Endocrine Therapy Medication Adherence - NCT ID: NCT06388304 - Study ID: 23-0556 - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2024-12-12 - Lead Sponsor: Joanna Arch ### Study Description The purpose of this study is to pilot and refine an online behavioral intervention based on Positive Affect Training (PAT) that aims to increase positive emotional attitudes and decrease negative emotional attitudes toward endocrine therapy (ET, i.e., anti-hormonal medication) and to increase positive affect and decrease negative affect more generally, among post-treatment breast cancer survivors who are prescribed ET to prevent recurrence of breast cancer. ### Conditions - Breast Cancer - DCIS ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - THRIVE Online PAT Program ### Outcomes Primary Outcomes - Acceptability of THRIVE intervention (AIM) - Feasibility of THRIVE intervention - Client Satisfaction Survey Secondary Outcomes ### Location - Facility: University of Colorado Boulder, Boulder, Colorado, 80309, United States @@
## Deep Brain Stimulation in Tourette Syndrome - NCT ID: NCT06388291 - Study ID: CTU/2018/321 - Status: RECRUITING - Start Date: 2022-08-02 - Completion Date: 2025-06-30 - Lead Sponsor: University College, London ### Study Description Op-TICS is a clinical investigation of the use of Deep Brain Stimulation (DBS), with a CE marked implantable device, to reduce severe motor and vocal tics in patients who suffer from Tourette Syndrome (TS).It is a randomised, double-blind, crossover clinical investigation for 20 patients. Op-TICS will be performed at the National Hospital for Neurology \& Neurosurgery.Following DBS surgery, participants will first enter an open adjustment phase, of 6 months, where the electrical stimulation settings of the device are optimised. Participants will then enter the double-blind phase that will include successively up to 2 weeks with stimulation on and up to 2 weeks with the stimulation off in a randomised order.The primary outcome measure is the tic severity score measured by the Yale Global Tic Severity Scale -Total Tic Score after two weeks OFF-stimulation versus two weeks ON-stimulation in the double-blind randomised crossover phase ### Conditions - Tourette Syndrome - Deep Brain Stimulation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Deep Brain Stimulation ### Outcomes Primary Outcomes - Tic severity score measured by the YGTSS-TTS (total tic) after two weeks OFF-stimulation versus two weeks ON-stimulation in the double-blind randomised crossover phase Secondary Outcomes - MRVRS at the end of the OFF-stimulation state versus the end of the ON-stimulation state in the blinded, randomised crossover phase. - Change in the MRVRS between baseline 0 and the end of the open-phase (Baseline 1) - Change in the YGTSS (global) between baseline 0 and the end of the open-phase (Baseline 1) - Change in the GTS-QOL questionnaire measures at baseline 0 and the end of the open-phase (Baseline 1) - Change in the YBOCS between baseline 0 and the end of the open-phase (Baseline 1) - Change in the BDI scale between baseline 0 and the end of the open-phase (Baseline 1) - Change in the BAI scale between baseline 0 and the end of the open-phase (Baseline 1) - Change in the BAARS-IV between baseline 0 and the end of the open-phase (Baseline 1) - Safety of DBS as indicated by the number of participants with any adverse events and number with any serious adverse events ### Location - Facility: National Hospital of Neurology & Neurosurgery, London, N/A, N/A, United Kingdom @@
## Cost-effectiveness Analysis of an Antimicrobial Stewardship Program in Regione Lombardia (RF-net2018) - NCT ID: NCT06388278 - Study ID: NET-2018-12366982-4/ASP_LOMB - Status: RECRUITING - Start Date: 2023-03-01 - Completion Date: 2025-04-15 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description Cost-effectiveness analysis of an Antimicrobial Stewardship program in Regione Lombardia: "RF-net2018" is a prospective, experimental, multicenter, pre-post study, whose objectives are the evaluation of the efficiency of economic resources allocated to the antimicrobial stewardship program (AMS) in patients with infection and in patients with infections caused by carbapenem-resistant gram-negative (CR-GN) bacteria, identified in a network of 18 hospital facilities participating in our study. Moreover, this study aims to compare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project. The study will include two main phases of analysis: the pre-intervention-phase and the intervention phase, both of 6 months duration. The pre-intervention phase will serve as a control for the intervention phase. The intervention phase is represented by antimicrobial stewardship activities which have been implemented in the network of 18 hospital facilities and that include a group of activities listed above (Hospital commitment, Tracking and reporting, Action and Education). Data source and analysis for the cost-effectiveness analysis, using month-department as statistical unit, are regional data: Discharge record ICD-9 codes (identification of target population 1, 2, 3, average days of hospitalization and mortality), R file (for antibiotic drug consumption month-ward) and Microbio (identification of target population 2, CR-GN and MRSA bacteremia and Cases of C. difficile infection). For what concerns healthcare costs data, each Management control office of the 18 facilities has to provide: AVERAGE HOSPITALISATION DAYS, NUMBER OF HOSPITALIZED AND TRANSFERRED PATIENTS and HEALTHCARE COSTS (healthcare personnel, diagnostic services, surgical interventions and consumption of operating rooms). ### Conditions - Antimicrobial Stewardship - Cost-effectiveness Analysis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - evaluate the efficiency of the economic resources allocated to the antimicrobial stewardship program (AMS) through a cost-effectiveness analysis in patients with infection - evaluate the efficiency of the economic resources allocated to the AMS program through a cost-effectiveness analysis in patients with infections caused by carbapenem-resistant gram-negative (CR-GN) bacteria. - compare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project Secondary Outcomes ### Location - Facility: IRCCS Fondazione Policlinico of Milan, Milan, N/A, 20135, Italy @@
## Emotional and Oral Characteristics of Patients That Attend a Dental Consultation for the Extraction of Third Molars - NCT ID: NCT06388265 - Study ID: 18/2018, Acta 26-6-2018 - Status: COMPLETED - Start Date: 2022-01-09 - Completion Date: 2023-07-31 - Lead Sponsor: University of Barcelona ### Study Description Analyze the level of anxiety, hemodynamic parameters, oral status, and satisfaction among patients undergoing third molar extraction, we will assess those who attend the Master of Oral Medicine, Surgery, and Implantology program at the University of Barcelona. ### Conditions - Anxiety and Fear ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Trifold information ### Outcomes Primary Outcomes - Changes in STAI-S - Changes in MDAS Secondary Outcomes - Changes in blood pressure - Changes in Heart rate - Changes in Oxygen saturation - Patient Satisfaction of procedure ### Location - Facility: Hospital Odontològic Universitat de Barcelona, L'Hospitalet De Llobregat, Barcelona, 08907, Spain @@
## Electrochemotherapy Induces Changes in the Tumor Microenvironment of Cutaneous and Subcutaneous Metastases in Patients With Cutaneous Melanoma - NCT ID: NCT06388252 - Study ID: ERID-KSOPR-0049/2023 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-11-10 - Completion Date: 2025-11-30 - Lead Sponsor: Institute of Oncology Ljubljana ### Study Description In the last 10 years, the treatment of metastatic cutaneous melanoma has changed dramatically. The new systemic treatment with immunotherapy has led to a dramatic improvement in quality of life and overall survival. Systemic treatment means that the patient receives the drug as an infusion into a vein. Unfortunately, we know that immunotherapy is not equally successful in all patients. Recent studies have shown that the success of the treatment is not only influenced by the cellular composition of the metastasis, but also by its surroundings. This is called tumor microenvironment. Depending on the differences in the composition of this microenvironment, some metastases can be described as immunologically hot and others as immunologically cold. Immunologically hot metastases respond better to immunotherapy than immunologically cold metastases.Studies have shown that with some interventions we can change the tumor microenvironment from being immune-cold to being immune-hot. Electrochemotherapy is one of the interventions that might improve the efficacy of immunotherapy in cutaneous melanoma. Electrochemotherapy is an established method for the local treatment of tumors, in which only a certain tumor is treated with special electrodes, to which a weak electric current is applied. We hypothesize that electrochemotherapy stimulates the body's own immune response and enables more effective treatment. Since immunotherapy also stimulates the body's own immune response to cutaneous melanoma cells, the interaction of the two drugs could be even more successful. Recent research results support this assumption.The primary objective is to evaluate the changes in the tumor microenvironment of cutaneous and subcutaneous melanoma metastases induced by electrochemotherapy, based on the histologic analysis of treated and untreated metastases before and after treatment. The secondary aim is to determine whether the changes in the tumor microenvironment differ depending on the chemotherapeutic agent used.The results will help us to better understand the synergistic effects of electrochemotherapy and immunotherapy on cutaneous melanoma metastases. The combination of systemic immunotherapy and electrochemotherapy could become an important treatment method for patients with metastatic melanoma. ### Conditions - Cutaneous Malignant Melanoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: BASIC_SCIENCE ### Interventions - Electrochemotherapy with Intratumoral Cysplatin - Electrochemotherapy with Intravenous Bleomycin ### Outcomes Primary Outcomes - Changes in the tumor microenvironment of cutaneoys and subcutaneousm melanoma metastases induced by electrochemotherapy Secondary Outcomes - Diferrent changes in the tumor microenvironment induced by electrochemotherapy with bleomycin or cysplatin ### Location - Facility: Institute of Oncology Ljubljana, Ljubljana, N/A, 1000, Slovenia @@
## Bioequivalence Study of Apixaban 5 mg Film-coated Tablets in Healthy Thai Volunteers - NCT ID: NCT06388239 - Study ID: BE24-006 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-26 - Completion Date: 2024-09-23 - Lead Sponsor: International Bio service ### Study Description The goal of this bioequivalence of two formulations of generic apixaban 5 mg film-coated tablets. Single-dose under fasting conditions and pharmacokinetics will be characterized for a total of 28 healthy adult human subjects. Twenty-eight (28) subjects will be randomly assigned to receive either generic apixaban 5 mg film-coated tablets (1 x 5 mg; Test) or ELIQUISTM (1 x 5 mg; Reference) in Period 1 and after the washout period they will receive the other formulation as a crossover fashion in Period 2. ### Conditions - Healthy Volunteer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Apixaban 5MG - ELIQUIS ### Outcomes Primary Outcomes - Plasma Area Under the Curve (AUC(0 to 36hr)) for Apixaban - Peak Plasma Concentration (Cmax) of Apixaban Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction - NCT ID: NCT06388226 - Study ID: IRB # 16143 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-06 - Completion Date: 2026-07-31 - Lead Sponsor: Indiana University ### Study Description The objective of this pilot study is to establish evidence to support the validity of HT in improving skeletal muscle function and physical capacity of patients with HFpEF. Our central hypothesis is that HT treatment will lead to improvements in skeletal muscle and microvascular function compared to a control intervention. As a result, we anticipate that patients treated with HT will demonstrate improved skeletal muscle microvascular blood flow and oxygenation resulting in enhanced exercise tolerance. To explore this hypothesis, we propose the following specific aim: Explore the effects of home-based HT on exercise tolerance in patients with HFpEF. ### Conditions - Heart Failure With Preserved Ejection Fraction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Leg heat therapy - Leg sham therapy ### Outcomes Primary Outcomes - Change in time to exhaustion during treadmill exercise Secondary Outcomes - Change in maximal pulmonary oxygen uptake during treadmill exercise - Change in triceps surae microvascular oxygenation during treadmill exercise - Change in systolic blood pressure - Change in diastolic blood pressure - Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score - Change in triceps surae microvascular oxygenation during reactive hyperemia - Change in triceps surae volume - Change in triceps surae intramuscular fat content - Change in the time constant for phosphocreatine recovery after dynamic exercise - Change in maximal plantar flexor strength ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Investigation of the Evolution of Gastric Emptying by Gastric Ultra Sonography in Patients Treated With GLP-1 Receptor Agonists on a 7 Days Pausing Period. - NCT ID: NCT06388213 - Study ID: GLP-1 RA patients GE by GUS - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-05 - Lead Sponsor: University Hospital, Geneva ### Study Description Glucagon-like-peptide-1 is a hormone released by the gut enteroendocrine cells. Its secretion occurs after each meal to enable production of insulin and inhibits the production of glucagon to lower after meal glycemia. It also inhibits gastric emptying and food intake. GLP-1 RA plays a role on GLP-1 receptors present on islet beta cells and delta cells of the pancreas to control insulin. GLP-1 receptors are also present in multiple region of the central nervous system such as the hypothalamus and hindbrain where it results in reducing food intake. For anesthesiologist it is important to understand how GLP-1 RA influence gastric emptying. Indeed, respecting a fasting period (6 hours for solid and 2 hours for liquid) before each surgery is one of the cornerstones of anesthesiology to significantly reduce the risk of pulmonary aspiration. One of the side effects of GLP-1 RA is slowing gastric emptying and increasing the risk of regurgitation in patient that observed a recommended fasting period. During 2023 a lot of cases reports have emerged of pulmonary aspiration or the presence of a full stomach in patient treated by GLP-1 RA for a type 2 diabetes. Despite recommendations made by the American Society of Anesthesiology, it is still unkown what is the best fasting period and how long patients should pause a long acting GLP-1 RA before surgery. In this observational study, we would like to determine the effect of GLP-1 RA on gastric emptying in patient scheduled for general anesthesia. We will measure and compare residual gastric content with gastric ultrasonography in patients treated by GLP-1 RA and in those who are not. We will also do these comparisons in a group of patients with type 2 diabetes treated by weekly GLP-1 RA at different days after the injection of the medication. Our hypothesis is that we will observe a reduction in gastric residue in patients who stopped weekly GLP-1 RA 7 days prior the examination compared to those who have stopped less days considering the same fasting period. This would lead us to propose an optimal duration of stopping time for GLP-1 inhibitors in the preoperative period. ### Conditions - Diabetes Mellitus, Type 2 - Anesthesia - Pulmonary Aspiration of Gastric Contents ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Gastric Ultrasonography ### Outcomes Primary Outcomes - Reduction of 5.5 cm2 of the CSA in patients pausing 7 days their GLP-1 RA treatment. Secondary Outcomes - Correlation between a full stomach evaluated on gastric ultrasonography and gastric symptoms such as nausea and bloating. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa - NCT ID: NCT06388200 - Study ID: OCU400-301 - Status: RECRUITING - Start Date: 2024-04-26 - Completion Date: 2026-10-30 - Lead Sponsor: Ocugen ### Study Description This is a Phase 3 study to Assess the Efficacy, Safety and Tolerability of OCU400 in patients with retinitis pigmentosa (RP) associated with RHO mutations and patients with any other RP associated mutation with a clinical phenotype of RP.This is a multicenter, assessor blinded and randomized study which will enroll 150 subjects. ### Conditions - Retinitis Pigmentosa ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sub-Retinal Administration of OCU400-301 ### Outcomes Primary Outcomes - Number of participants with change in functional vision in the study eye of RP subjects as assessed by LDNA - Number of participants with change in functional vision in the study eye in Gene Agnostic group as assessed by LDNA Secondary Outcomes - Number of participants with change in functional vision in the all treated eyes of RP subjects as assessed by LDNA - Number of participants with change in functional vision in the all treated eyes of subjects in Gene Agnostic Arm as assessed by LDNA - Number of participants with change in visual function in subjects with RHO mutation as assessed by LLVA letter score - Number of participants with change in visual function in Gene Agnostic Arm as assessed by LLVA letter scores - Ocular and non-ocular Events ### Location - Facility: Associated Retina Consultants, Phoenix, Arizona, 85020, United States @@
## A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight - NCT ID: NCT06388187 - Study ID: NN9838-7749 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-24 - Completion Date: 2026-04-10 - Lead Sponsor: Novo Nordisk A/S ### Study Description This study will look at how well CagriSema helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be prescribed by doctors. In the study, participant will either get CagriSema or dummy medicine and which treatment participant get is decided by chance. The study will last for about 1½ years for each participant. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cagrilintide - Semaglutide - Placebo ### Outcomes Primary Outcomes - Relative change in body weight - Achievement of ≥5% weight reduction Secondary Outcomes - Achievement of ≥10% weight reduction - Achievement of ≥15% weight reduction - Achievement of ≥20% weight reduction - Change in waist circumference - Change in systolic blood pressure - Ratio to baseline in lipids: Total cholesterol - Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol - Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol - Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol - Ratio to baseline in lipids: Triglycerides - Ratio to baseline in lipids: Free fatty acids ### Location - Facility: Aurora FDRC Inc., Costa Mesa, California, 92627, United States @@
## Idiopathic Generalized Epilepsy Syndromes - NCT ID: NCT06388174 - Study ID: S2022-0336 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2033-12-31 - Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University ### Study Description The idiopathic generalized epilepsies (IGEs) have historically included the syndromes childhood absence epilepsy (CAE), juvenile absence epilepsy (JAE), juvenile myoclonic epilepsy (JME), and epilepsy with generalized tonic-clonic seizures alone (GTCA). Recognition of the IGEs is important for clinical care, as it informs diagnosis, prevents unnecessary investigation, allows optimal selection of anti-seizure medications (ASMs), and provides prognostic guidance.According to the new ILAE definition in 2022, the study aims to describe the clinical features, electroencephalographic, imaging findings and long-term prognosis. ### Conditions - Epilepsy - Epilepsy, Idiopathic Generalized ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The proportion of drug-resistent epilepsy - The proportion of seizure freedom Secondary Outcomes - The proportion of psychiatric comorbidity - The proportion of psychosocial outcome - The proportion of seizure relapse after antiseizure medication withdrawn ### Location - Facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China, Hangzhou, Zhejiang, 310000, China @@
## Neural Autoantibody Prevalence in New-onset Focal Seizures of Unknown Etiology - NCT ID: NCT06388161 - Study ID: Yan2022-0336 - Status: RECRUITING - Start Date: 2023-08-01 - Completion Date: 2030-12-31 - Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University ### Study Description Seizure is one of the most common symptoms in autoimmune encephalitis with neuronal surface-mediated antibodies. Interestingly, some patients may exhibit new-onset seizures as the initial manifestation without fulminant sign of encephalitis, particularly in the early stage.It is essential to recognize these patients early and to perform antibody testing, as studies have reported early immunotherapy can improve their clinical outcomes. At the same time, it is important to limit the number of patients who require testing, for the sake of specificity and cost effectiveness. Thus, this prospective, multicenter study aims to identify neural antibodies in patients with focal seizures of unknown etiology, and to create a score to preselect patients requiring autoantibody testing. ### Conditions - Epilepsy - Encephalitis Autoimmune ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Detectable serum neural autoantibodies - Neuronal surface antibodies-mediated autoimmune- encephalitis Secondary Outcomes - The proportion of seizure freedom - The proportion of drug-resistent epilepsy - Clinical severity and recovery ### Location - Facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China, Hangzhou, Zhejiang, N/A, China @@
## Endovascular Treatment for eXtra-Large Ischemic Stroke - NCT ID: NCT06388148 - Study ID: XL STROKE-2 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2027-01-31 - Lead Sponsor: Zhongming Qiu ### Study Description The role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion. ### Conditions - Stroke, Acute Ischemic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Medical management - Endovascular thrombectomy ### Outcomes Primary Outcomes - Modified Rankin Scale score Secondary Outcomes - Rate of successful reperfusion - Rate of excellent outcome - Rate of functional independence - Rate of independent ambulation ### Location - Facility: Xiangtan Central Hospital, Xiangtan, Hunan, 421001, China @@
## Serplulimab Combined With Nab-paclitaxel and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma - NCT ID: NCT06388135 - Study ID: SNC-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-05 - Lead Sponsor: Yang Jianjun, PhD ### Study Description Abstract Objective: This study aims to investigate the potential clinical impact of neoadjuvant immunotherapy in resectable esophageal squamous cell carcinoma (ESCC).The efficacy and safety of combining the programmed death 1 (PD-1) inhibitor serplulimab with nab-paclitaxel and cisplatin as neoadjuvant therapy in patients with resectable ESCC will be evaluated. Methods and analysis: A prospective, single-center, open-label cohort study will enroll 80 patients, with 40 patients allocated to the experimental group and 40 patients to the control group. Patients in the experimental arm will undergo 3 cycles of neoadjuvant therapy comprising serplulimab, cisplatin, and nab-paclitaxel, while those in the control arm will receive 3 cycles of neoadjuvant therapy with cisplatin and nab-paclitaxel. The primary efficacy endpoint will be the assessment of pathological complete response (pCR) following neoadjuvant therapy. Secondary efficacy endpoints will include major pathological response (MPR), disease-free survival, objective response rate (ORR), and monitoring of adverse events (AEs).Ethics: Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital (Xijing Hospital) of Air force Military Medical University (KY20242052-C-1). ### Conditions - Esophageal Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Serplulimab Combined With Nab-paclitaxel and Cisplatin - nab-paclitaxel，Cisplatin ### Outcomes Primary Outcomes - pCR Secondary Outcomes - MPR - DFS - ORR - AEs ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Metastatic Breast Cancer Patients - NCT ID: NCT06388122 - Study ID: 23-009689 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-15 - Completion Date: 2026-06-15 - Lead Sponsor: Mayo Clinic ### Study Description The purpose of this study is to explore the clinical utility of routinely measuring thymidine kinase activity (TKa) in HR+ metastatic breast cancer patients receiving treatment with any approved endocrine therapy either alone or in combination with any approved CDK4/6 inhibitor. ### Conditions - HER2-negative Breast Cancer - Hormone-receptor-positive Breast Cancer - Metastatic Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Biospecimen Collection ### Outcomes Primary Outcomes - DiviTum®TKa assay as an early predictor of primary treatment resistance Secondary Outcomes ### Location - Facility: Mayo Clinic in Florida, Jacksonville, Florida, 32224-9980, United States @@
## Positive Peers Intervention Clinical Trial - NCT ID: NCT06388109 - Study ID: IRB15-00741 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-11 - Lead Sponsor: MetroHealth Medical Center ### Study Description The goal of this clinical trial is to learn if the Positive Peers mobile app intervention increases rates of viral suppression in young (13-34 y/o) persons with HIV.Does use of the Positive Peers app improve viral suppression among young minority persons with HIV? What user characteristics are associated with a) viral suppression, b) retention in care, and c) perceived HIV-related stigma?Participants will:* download the mobile app onto their personal smartphone* Use the mobile app as they find useful* complete online surveys at enrollment, 3 mo, 6, mo, 9 mo and 12 months. ### Conditions - HIV Infections ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Positive Peers mobile app ### Outcomes Primary Outcomes - Viral suppression Secondary Outcomes - Correlates of app use and viral suppression - Correlates of app use and retention in care - Correlates of app use and HIV related perceived stigma ### Location - Facility: Northeast Valley Health Corporation, Van Nuys, California, 91405, United States @@
## CLAD Deconvolved PERG Responses in Glaucoma Patients - NCT ID: NCT06388096 - Study ID: PERGCLAD001 - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2025-06-01 - Lead Sponsor: Jorvec Corp. ### Study Description Glaucoma is a progressive disease resulting in blindness. Determining the onset of the disease is critical so patients may obtain treatment to preserve useful vision. This study will collect data from a population of glaucoma suspects (with positive factors for the disease but with normal vision) along with a population of age matched controls using the pattern electroretinogram (PERG) and other standard eye tests for glaucoma. The PERG measures the function of retinal ganglion cells (RGCs) which come together to form the optic nerve. RGCs may become dysfunctional before dying. The Continuous loop deconvolution technique (CLAD) will be used to extract transient PERG responses in both glaucoma suspects and age matched controls. All patients will be monitored with PERG, Optic Coherence Tomography (OCT) and other ancillary tests over 2 years. CLAD will be compared with conventional techniques of monitoring glaucoma (standard PERG, OCT, visual field etc) to see if the CLAD is better at distinguishing between glaucoma suspects and controls. ### Conditions - Glaucoma, Suspect ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No Intervention Provided ### Outcomes Primary Outcomes - PERG Amplitude - PERG Latency Secondary Outcomes ### Location - Facility: University of Miami, Bascom Palmer Eye Institute 900 NW 17th Street, Miami, Florida, 33136, United States @@
## A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt Disease - NCT ID: NCT06388083 - Study ID: LBS-008-CT07 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2027-07 - Lead Sponsor: Belite Bio, Inc ### Study Description The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of tinlarebant in subjects with Stargardt Disease ### Conditions - STGD1 - Stargardt Disease 1 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tinlarebant - Placebo ### Outcomes Primary Outcomes - To measure the annualized rate of change from baseline lesion size in aggregate area of atrophy Secondary Outcomes - To measure the annualized rate of change in total area of atrophy - Change in BCVA measured by the ETDRS method ### Location - Facility: Belite Study Site, Dallas, Texas, 75231, United States @@
## To Evaluate the Efficacy and Safety of HUC3-053 in Patients With Dry Eye Syndrome - NCT ID: NCT06388070 - Study ID: HUC3-053 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Huons Co., Ltd. ### Study Description This is a multi-center, randomized, double-blinded, non-inferiority study to evluate the efficacy and safety of HUC3-053 in patients with dry eye syndrome.After a 2-week run-in period, patients will be randomized equally to the HUC3-053 or Hyalein Mini Drops administered bilaterally five to six times a day for 12 weeks. ### Conditions - Dry Eye Syndromes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HUC3-053 - Hyalein Mini Drops ### Outcomes Primary Outcomes - Change from Baseline in Corneal staining score Secondary Outcomes - Change from Baseline in Corneal staining score - Change from Baseline in Conjunctival staining score - Change from Baseline in Schirmer test - Change from Baseline in Tear film break-up time - Change from Baseline in Ocular surface disease index - Change from Baseline in Soreness after eye drop assessed by NRS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Intraoperative Ultrasound in Crohn's Disease - NCT ID: NCT06388057 - Study ID: 5836 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-09-01 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description To study the role of intraoperative ultrasound of small bowel as a possible tool that can reduce the rate of histologically involved resection margins from Crohn's Disease. ### Conditions - Crohn Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Intraoperative Small Bowel Ultrasonography ### Outcomes Primary Outcomes - Specificity and sensibility of intraoperative ultrasound of small bowel in identifying resection margins histologically involved by Crohn's disease Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## ACT for Infertility: Case Series - NCT ID: NCT06388044 - Study ID: PRO00115010 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Duke University ### Study Description In the United States, around 19% of reproductive-aged couples suffer from infertility. The psychological distress associated with infertility is well-established; those diagnosed commonly experience depression and anxiety symptoms, diminished quality of life, and relationship dissatisfaction. In the current study, the investigators report on a case series, in which up to 10 infertility patients will receive 12 sessions of Acceptance and Commitment Therapy (ACT). The overarching goal for the current case series is to determine whether ACT might be well-suited for infertility patients experiencing distress. The specific aims are: 1) to describe the components of the intervention that was delivered; 2) to determine the extent to which infertility patients perceive a 12-session ACT intervention beneficial and acceptable; 3) to describe change in mood, stress, and ACT processes across 12 sessions of ACT; and 4) to highlight potential processes through which ACT might promote benefits to the patient by describing how change in mood, stress, and ACT processes relate to each other over the course of 12 sessions of ACT. ### Conditions - Infertility - Psychological Distress - Acceptance and Commitment Therapy - Psychological Flexibility ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Acceptance and Commitment Therapy ### Outcomes Primary Outcomes - Acceptability of the Intervention Secondary Outcomes - Change in Fertility Problem Inventory (FPI) - Change in Patient Health Questionnaire 9 (PHQ-9) - Change in Patient Health Questionnaire 2 (PHQ-2) - Change in Generalized Anxiety Disorder Questionnaire 7 (GAD-7) - Change in Generalized Anxiety Disorder Questionnaire 2 (GAD-2) - Change in Modified Differential Emotions Scale (mDES) - Change in Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT-15) - Change in Intolerance of Uncertainty (IUS) - Change in Valuing Questionnaire (VQ) - Change in Values-Based Behavior ### Location - Facility: Duke North Pavilion, Durham, North Carolina, 27705, United States @@
## ICI Rechallenge for Advanced NSCLC With Long-Term Response to First-Line ICI - NCT ID: NCT06388031 - Study ID: CAPTRAL2024v1 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-10 - Completion Date: 2027-12-10 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description An exploratory phase II trial of immune checkpoint inhibitors (ICIs, anti-PD-1/anti-PD-L1) as second-line treatment with advanced non-small cell lung cancer (NSCLC) who had long-term response to first-line immunotherapy (with or without chemotherapy).This study aims to evaluate efficacy and safety of ICI rechallenge in long-term responders to prior ICI. Furthermore, it seeks to identify biomarkers capable of predicting the efficacy of immunotherapy and prognosis. ### Conditions - Non-small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Immune checkpoint inhibitor ### Outcomes Primary Outcomes - Progression Free Survival (PFS) Secondary Outcomes - Overall Survival (OS) - Objective Response Rate (ORR) - Progression Free Survival 2 (PFS 2) ### Location - Facility: Peking Union Medical College Hospital, Beijing, N/A, 100730, China @@
## Tailoring Therapy in Post-surgical Patients With Low-risk Endometrial Cancer - NCT ID: NCT06388018 - Study ID: NRG-GY032 - Status: SUSPENDED - Start Date: 2024-04-16 - Completion Date: 2025-01-09 - Lead Sponsor: NRG Oncology ### Study Description This phase II trial tests how well tailoring therapy in post-surgery works in patients with low-risk endometrial cancer. The usual approach for patients with low-risk endometrial cancer is treatment with surgery. In this study, tissue that is removed as part of the surgical procedure is analyzed in the pathology laboratory to help guide the doctor to decide whether or not additional treatment such as radiation and or chemotherapy should be recommended. ### Conditions - Stage I Uterine Corpus Endometrial Stromal Sarcoma AJCC V8 - Stage II Uterine Corpus Endometrial Stromal Sarcoma AJCC V8 - Stage III Uterine Corpus Endometrial Stromal Sarcoma AJCC V8 ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Clinical Observation - External Beam Radiation Therapy - High-Dose-Rate Vaginal Brachytherapy - Computed Tomography - Positron Emission Tomography - X-Ray Imaging - Magnetic Resonance Imaging - Questionnaire Administration ### Outcomes Primary Outcomes - Time to pelvic recurrence Secondary Outcomes - Time to isolated vaginal recurrence - Recurrence-free survival - Endometrial cancer-specific survival - Fear of recurrence ### Location - Facility: Washington University School of Medicine, Saint Louis, Missouri, 63110, United States @@
## The Application of Emotion Release Technology in Anxiety Patients Before Daytime Thyroid Surgery - NCT ID: NCT06388005 - Study ID: 2021-060 - Status: COMPLETED - Start Date: 2022-03-01 - Completion Date: 2022-07-31 - Lead Sponsor: Yantai Yuhuangding Hospital ### Study Description Research methods1 Data collection and evaluation tools1. The general data record sheet was self-designed by the research team, and the collected content included age, gender, BMI, occupation, general family status, economic situation, history of hypertension and cardiovascular diseases, history of anxiety and depression, self-rating anxiety scale (SAS) score, blood pressure and heart rate before and after intervention, disease diagnosis and severity, etc.2. The anxiety was self-scored using the VAS-A (0-10 points), with 0 point as no anxiety and 10 as severe anxiety.3. Negative emotional intensity was scored using the subjective unit of disturbance scale (SUDS, 0-10 points), with 0 point as no and 10 points as severe.4. Nursing satisfaction was scored by the self-designed questionnaire (1-5 points): 5 points, very satisfied; 4 points, relatively satisfied; 3 points, satisfied; 2 points, medium; 1 point, dissatisfied.2 Intervention method of the control group The control group was given routine nursing. After entering the pre-anesthesia room, the patients were scored using the VAS-A, and those with VAS-A score ≥ 5 were considered to meet the inclusion criteria. After identity authentication, the preoperative precautions and reasons for waiting in the pre-anesthesia room were explained to the patients, and answers were provided to the questions raised by the patients. After routine nursing, VAS-A score was recorded, blood pressure and heart rate were monitored, and nursing satisfaction was inquired. The survey of patient satisfaction with nursing was completed before entering the operating room.3 Intervention method of the experimental group 3.1 Researcher training Before intervention, 4 nurses were trained for 5 d by a nurse with EFT qualification certificate, 1 h per day. The training content included: theoretical knowledge of EFT, tapping techniques, etc. After training, two assessments were conducted. Only those who scored above 90 points in both assessments could participate in the study.3.2 Operating instructions The acupoint diagram was distributed to the experimental group by nurses, and the essentials and precautions of acupoint tapping were explained. The nurses demonstrated and tapped the acupoints on the patients while explaining, and then instructed them to tap on their own until they were able to complete the task independently and proficiently. For patients with upper limb vein puncture, proper fixation and close observation were needed, and the flexible nature of the puncture needle that would not affect operations was explained to the patients to eliminate their concerns.3.3 Intervention content After routine nursing, the patients received EFT intervention. In addition, subjective anxiety was scored, blood pressure and heart rate were monitored, and nursing satisfaction was surveyed after admission and intervention. The specific methods are as follows.1. Preparation stage The patients with VAS-A score ≥ 5 meeting the inclusion criteria were in a comfortable position with eyes closed, and adopted breathing exercise to relax their whole body. The patients were guided to summarize the main current distresses, such as fear, tension, pain, surgical prognosis, economic burden, etc., name the caused negative emotions, and use the SUDS to evaluate the intensity of negative emotions. The patients were asked to recite silently the prompt "Although I am very \\ (a negative emotional word) now, I still deeply and completely love and accept myself" while tapping.2. Tapping stage The patients were guided to gently massage the sore points on both sides of the body (2-3 fingers below the midpoint of the clavicle) with their five fingers together in a clockwise direction, while silently reciting the prompt 3 times. Then, the patients were guided to close their index and middle fingers together and gently tap the Zanzhu, Tongziliao, Chengqi, Renzhong, Chengjiang, Shufu, Dabao and Baihui acupoints successively with their fingertips at 2-3 times/s and the force they can bear. The prompt was recited silently when tapping each acupoint. After 3-5 rounds of tapping, 3 deep breaths were taken to re-evaluate the intensity of negative emotions.3. Feedback stage After tapping, the patients communicated with the nurses at least once about their evaluated negative emotional intensity score and whether the score was accepted. If the tapping effect was not obvious, the evaluation was conducted by nurses, and the patients were guided to massage the sore points while silently reciting the prompt 3 times. To relieve reverse psychological drive, tapping was continued until the intensity of negative emotions reduced. ### Conditions - Anxiety - Day Surgery - Preoperative Nursing Care - Emotional Freedom Technique ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - emotional freedom technique (EFT) ### Outcomes Primary Outcomes - VAS-A score - hemodynamic and endocrine indicators - nursing satisfaction Secondary Outcomes ### Location - Facility: Yantai Yuhuangding Hospital, Yantai, Shandong, 264000, China @@
## Evaluation of the Agreement Between a Consultation With a Nurse Acquiring Three-dimensional Intraoral Images Made With a 3D Intraoral Camera and the Standard Consultation With a Dental Surgeon, in Institutionalized Elderly Subjects - NCT ID: NCT06387992 - Study ID: PP24023 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-06 - Lead Sponsor: CHU de Reims ### Study Description The primary objective of this study will be to assess the agreement between a dental consultation with a nurse acquiring intraoral images, using a 3D intraoral camera, and a standard consultation with a dental surgeon, in institutionalized elderly subjects Institutionalized subjects planned to have a dental consultation and eligible will be included once written informed consent is signed. Their dental consultation will start with a consultation with a nurse to record 3D intraoral images, then a consultation with a dental surgeon for standard dental care, blinded from the nurse consultation will be performed. Thereafter, 3D images will be analyzed by another dental surgeon blinded from the results of both consultations. Agreement on different outcomes between the analysis of the images acquired by the nurse and the standard dental evaluation by a dental surgeon will be assessed.Agreement on the results between the interpretation of the 3D images acquired by a nurse and the standard consultation by a dental surgeon could lead, in the long term, to a significant step forward in dental care of institutionalized patients.Indeed, training nursing home nurses to acquire 3D dental images would enable the identification of patients in need of immediate dental care and thus extend the possibilities of access to consultations with a dentist for these patients. This would increase the efficiency of care. ### Conditions - Dental Care for Institutionalized Elderly Persons ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Three-dimensional dental acquisition ### Outcomes Primary Outcomes - DMFT index Secondary Outcomes - Plaque control record - General Oral Health Assessment Index (GOHAI) ### Location - Facility: Damien JOLLY, Reims, N/A, N/A, France @@
## Advanced Development of Desorption Electrospray Ionization Mass Spectrometry for Intraoperative Molecular Diagnosis of Brain Cancer Using Pathology Biopsies - NCT ID: NCT06387979 - Study ID: 19-010725 - Status: RECRUITING - Start Date: 2020-10-26 - Completion Date: 2025-10-15 - Lead Sponsor: Mayo Clinic ### Study Description This study explores whether DESI-MS can be used to identify cancerous vs. noncancerous tissue during brain tumor surgery. ### Conditions - Glioma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Non-Interventional Study ### Outcomes Primary Outcomes - Pathological state of the tissue - Percentage of tumor infiltration - Presence of IDH mutations Secondary Outcomes ### Location - Facility: Mayo Clinic in Florida, Jacksonville, Florida, 32224-9980, United States @@
## A Randomized, Double-blind,Dose-escalating, Single-dose, Oral Phase I Clinical Study of Flunotinib Healthy People - NCT ID: NCT06387966 - Study ID: H-FNTN-PI-Ia - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2024-12-30 - Lead Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd ### Study Description Evaluate the safety and tolerability of a single increasing dose of Flibanserin Maleate tablets administered orally to healthy adult Chinese subjects; preliminarily assess the pharmacokinetic characteristics of a single dose of oral Flibanserin Maleate tablets ### Conditions - Healthy Person ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - flunotinib - flunotinib placebo ### Outcomes Primary Outcomes - Prilinostat Mesylate Pharmacokinetics (PK)：Cmax - Prilinostat Mesylate Pharmacokinetics (PK)：Tmax - The statistical parameters of fecal pharmacokinetics are the cumulative excretion of prototype drugs and major metabolites in feces (Ae0-144h) and excretion rate (Ae%); - Prilinostat Mesylate Pharmacokinetics (PK)：AUC0-∞ - Prilinostat Mesylate Pharmacokinetics (PK)：MRT - Prilinostat Mesylate Pharmacokinetics (PK)：Vd - Prilinostat Mesylate Pharmacokinetics (PK)：t1/2 - Prilinostat Mesylate Pharmacokinetics (PK)：CLz/F - Prilinostat Mesylate Pharmacokinetics (PK)：Vz/F - Prilinostat Mesylate Pharmacokinetics (PK)：Ke Secondary Outcomes ### Location - Facility: Chengdu Xinhua Hospital, Chengdu, Sichuan, 610000, China @@
## Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy - NCT ID: NCT06387953 - Study ID: STUDY00019480 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-06 - Lead Sponsor: University of Washington ### Study Description This is a randomized, prospective, double-blinded (patient and outcome-assessor) trial. Our goal is to assess efficacy of Bridge Therapy (versus sham bridge therapy) to prevent emergence agitation following general anesthesia.Primary Objective: Activation of Bridge Therapy from the time of the pre incision "time out" until 24 hours after admission to the PACU (Post Anesthesia Care Unit) is associated with reduced frequency and intensity of emergence agitation.Secondary Objective: Bridge Therapy activation will also result in a lower incidence of rescue pharmacologic treatment of agitation.Tertiary Objective: Activation of Bridge Therapy during a stable anesthetic state is associated with a reduced Patient State Index as measured on Sedline ### Conditions - Emergence Delirium - Agitation, Emergence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Bridge Therapy - Sham Therapy ### Outcomes Primary Outcomes - Emergence agitation - Emergence agitation Secondary Outcomes - Rescue pharmacologic treatment of agitation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Acute Metabolic Effects of Carbohydrate Restriction at Varying Energy Levels - NCT ID: NCT06387940 - Study ID: UEC 2019 008 FHMS - Status: COMPLETED - Start Date: 2019-11-05 - Completion Date: 2022-11-20 - Lead Sponsor: University of Surrey ### Study Description This study investigates how different low-carbohydrate diets affect metabolism and hunger in overweight adults. We will measure metabolic rates and blood metabolites. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - nEB Diet, followed for 36 hours - LC25 Diet, followed for 36 hours - LCEB Diet, followed for 36 hours ### Outcomes Primary Outcomes - Biomarkers in blood Measured - Resting metabolic rate Secondary Outcomes - Perceived Appetite Scores - Food intake ### Location - Facility: University of Surrey, Guildford, N/A, GU2 7XH, United Kingdom @@
## Effect of Home-exercise Programs Versus Supervised Core Stability Exercises on Hypertensive Patient With Low Back Pain - NCT ID: NCT06387927 - Study ID: PT-NEUR-10/2023-520 - Status: COMPLETED - Start Date: 2023-09-02 - Completion Date: 2024-02-20 - Lead Sponsor: Ahram Canadian University ### Study Description Thirty male and female hypertension patients with chronic mechanical non-specific low back pain were included in this randomized controlled study conducted at the Ababa Private Physical Therapy Center in Beni-Seuf, Egypt. They were randomly assigned into two equal groups; the study group A control (n = 15) had a supervised conventional core stability, while the study group B (n = 15) received a home exercise program. In both groups' patients had evaluations before and after their six-week course of therapy. Modified-modified Schober test was used to assess the active back range of motion (ROM), Arabic version of Oswestry disability index (ODI) was utilized to evaluate functional disability, and visual analog scale (VAS) was used to measure pain. ### Conditions - Hypertension - Low Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - home exercise program - the core stability exercise ### Outcomes Primary Outcomes - Assessment of pain - Assessment of lumbar flexion range of motion - Assessment of functional disability Secondary Outcomes ### Location - Facility: Faculty of physical therapy, Giza, N/A, 3387722, Egypt @@
## Efficacy of Pain Intervention With Deep Brain Stimulation Neuromodulation - NCT ID: NCT06387914 - Study ID: PID 16707 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-02 - Completion Date: 2027-05-02 - Lead Sponsor: University of Oxford ### Study Description The goal of this clinical trial is to learn if deep brain stimulation (DBS) works to treat severe pain following a stroke in adults. It will also learn about the safety of deep brain stimulation. The main questions it aims to answer are:* Does DBS lower the pain score in these participants.* What medical problems do participants have when having DBS? Researchers will compare different settings, to see if DBS works to treat severe post stroke pain.Participants will:* Undergo baseline screening procedures and have an MRI scan.* Have neurosurgery to put the DBS system in* Have follow up for 10 months* Visit the clinic at least 5 times in the study for check-ups and tests* Fill in questionnaires about pain and mood and have check ups remotely ### Conditions - Central Post Stroke Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Stimulation ON - Stimulation Pseudo-ON ### Outcomes Primary Outcomes - McGill Pain Questionnaire V2.0 -Short Form - Present Pain Intensity (MQ-SF-PPI) score Secondary Outcomes - Numerical Rating Scale (NRS) - McGill Pain Questionnaire V2.0 short form (MPQ-SF) McGill Pain Questionnaire V2.0 short form) MPQ-SF (McGill Pain Questionnaire V2.0 short form) - Brief Pain Inventory (BPI) - Short Form - Beck Depression Inventory (BDI II) - Patients' Global Impression of Change (PGIC) - EuroQol Quality of life (EQ5D-5L) - Healthy Days Measures (HDM) - Adverse Events (AEs) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Investigating Paclitaxel Toxicity in Breast Cancer: The Roles of Physical Activity and Body Composition. - NCT ID: NCT06387901 - Study ID: PABTOX - part 1 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-06 - Completion Date: 2025-10-31 - Lead Sponsor: Universitair Ziekenhuis Brussel ### Study Description This study looks into how a common breast cancer treatment, paclitaxel, can sometimes cause severe side effects that make it hard for patients to continue treatment. These side effects can significantly affect a patient's quality of life and even impact their recovery and overall health costs. What's interesting about this research is that it considers how a patient's lifestyle, specifically their physical activity levels and body makeup (like how much muscle and fat they have), might influence these side effects.The researchers are doing a detailed study with 40 women receiving paclitaxel treatment, tracking how the drug is processed in their bodies and how their body composition and physical activity might play a role in the side effects they experience. They are using a special method to monitor drug levels in the blood and are also keeping tabs on the patients' health and physical activity through questionnaires and modern tracking devices.The goal here is twofold: first, to better understand why these side effects happen to some people and not others, and second, to develop a model that can predict who might be at higher risk for these side effects based on their body composition, lifestyle, and how their body handles the drug. This could lead to more personalized treatment plans that could help reduce the risk of severe side effects and improve the overall treatment experience for patients with breast cancer.In simpler terms, this research is trying to find a way to make breast cancer treatment with paclitaxel safer and more comfortable by considering how a person's lifestyle and body type might affect their reaction to the drug. This could make a big difference in helping patients complete their treatment successfully and with a better quality of life. ### Conditions - Breast Cancer - Paclitaxel Adverse Reaction - Chemotherapeutic Toxicity - Chemotherapeutic Agent Toxicity - Body Weight - Physical Inactivity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Paclitaxel Chemotherapy ### Outcomes Primary Outcomes - Identification of Body Composition Parameter (Muscle mass) Related to Dose-Limiting Toxicities (DLTs) - Identification of Body Composition Parameters (Fat %) Related to Dose-Limiting Toxicities (DLTs) - Identification of Physical Activity Parameters Related to Dose-Limiting Toxicities (DLTs) Secondary Outcomes - Paclitaxel Exposure Analysis (Cmax) - Paclitaxel Exposure Analysis (AUC) - Number and Type of Dose-Limiting Toxicities ### Location - Facility: Vrije Universiteit Brussel, Brussel, Jette, 1090, Belgium @@
## The Effect of Mother's Voice on the Levels of Pain and Comfort in Newborns - NCT ID: NCT06387888 - Study ID: E-31034136-302.08.01-4221 - Status: COMPLETED - Start Date: 2021-07-01 - Completion Date: 2022-04-30 - Lead Sponsor: Istanbul Medipol University Hospital ### Study Description This study was conducted in a randomized controlled experimental type to determine the effect of maternal voice during care on pain and comfort level in term newborns receiving mechanical ventilation. The sample of the study was consisted of 60 term newborns receiving mechanical ventilation who were hospitalized in the 7-bed Neonatal Intensive Care Unit of a private hospital in Istanbul in accordance with the selection criteria. Introductory Information Form, Vital Signs Follow-up Form, Neonatal Comfort Behavior Scale and Neonatal Pain Scale (NPASS) forms prepared by the researchers were used as data collection tools. ### Conditions - Newborns ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Listening to mother's voice ### Outcomes Primary Outcomes - Neonatal Comfort Behavior Scale Secondary Outcomes - Neonatal Comfort Behavior Scale (COMFORTneo): ### Location - Facility: Istanbul Medipol University Hospital, Istanbul, Beykoz, N/A, Turkey @@
## Cohort in Qianwan New District, Ningbo - NCT ID: NCT06387875 - Study ID: Hangzhou Bay Cohort - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2027-06-30 - Lead Sponsor: RenJi Hospital ### Study Description Our objective is to carry out research on prevention and control of noncommunicable chronic diseases, and establish a risk prediction mechanism for chronic diseases to promote early detection, early diagnosis and early treatment of chronic diseases in natural population in Qianwan District of Ningbo, significantly reduce medical costs and extend population life span. ### Conditions - Cardiovascular Diseases - Stroke - Non-Communicable Chronic Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - death - incidence of cardio-cerebrovascular diseases - incidence of other non-communicable chronic diseases Secondary Outcomes ### Location - Facility: Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University, Shanghai, N/A, N/A, China @@
## Pharmacokinetics of Inhaled Levosimendan - NCT ID: NCT06387862 - Study ID: 2022SIMBIOV - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2025-01 - Lead Sponsor: Universitair Ziekenhuis Brussel ### Study Description Determination of biological availability, time-to-peak and elimination half-life of inhaled levosimendan by administration of an inhaled- and intravenous dose of levosimendan. ### Conditions - Left Ventricular Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: BASIC_SCIENCE ### Interventions - Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Inhaled - Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Intravenous ### Outcomes Primary Outcomes - Bioavailability of inhaled levosimendan - Time-to-peak of inhaled levosimendan - Elimination half-life of inhaled levosimenan Secondary Outcomes - Effect of inhaled levosimendan on MAP - Effect of inhaled levosimendan on TVR - Effect of inhaled levosimendan on CO - Effect of inhaled levosimendan on LVOT VTI - Effect of inhaled levosimendan on FAC of the right vetricle - Effect of inhaled levosimendan on S' - Effect of inhaled levosimendan on SPAP ### Location - Facility: UZ Brussel, Brussel, N/A, 1090, Belgium @@
## Aromatherapy Effect on Pain and Anxiety After C-section - NCT ID: NCT06387849 - Study ID: 03/2023 - Status: COMPLETED - Start Date: 2023-04-21 - Completion Date: 2023-08-31 - Lead Sponsor: University Tunis El Manar ### Study Description A prospective randomized triple blinded study conducted in the obstetrics gynecology department of Ben Arous hospital over a period of four months and 10 days between April 2023 and August 2023.The aim of this study was to evaluate the effectiveness of lavender aromatherapy on postoperative pain and anxiety after cesarean section under spinal anesthesia in Tunisian women. ### Conditions - Post-operative Pain - Post-operative Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Aromatherapy - Placebo ### Outcomes Primary Outcomes - Post-operative pain level - Post-operative anxiety level Secondary Outcomes - Heart Rate (HR) - Systolic Blood Pressure (SBP) - Diastolic Blood Pressure (DBP) - Respiratory Rate (RR) - Pulsatile Oxygen Saturation ### Location - Facility: Ben Arous Regional Hospital, Ben Arous, N/A, N/A, Tunisia @@
## LINC01844 as a Diagnostic Biomarker for POCD in Elderly Patients - NCT ID: NCT06387836 - Study ID: B2024-063 - Status: RECRUITING - Start Date: 2024-02-21 - Completion Date: 2025-06-30 - Lead Sponsor: Shanghai Zhongshan Hospital ### Study Description Postoperative cognitive dysfunction (POCD) is a common complication after surgery that is associated with more adverse events and death. The goal of this observational study is to learn about the diagnosis performance of long intergenic non-coding RNA(LINC01844) level in blood of older people for POCD. The main question it aims to answer is:Does the relative level of LINC01844 in blood help diagnose POCD of older people after surgery? Participants undergoing elective lumbar decompression and fusion will finish neuropsychological evaluations one day before and 1st, 3rd and 5th day after surgery. At the same timepoint, the relative level of LINC01844 in blood will also be tested. ### Conditions - Postoperative Cognitive Dysfunction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - relative level of LINC01844 Secondary Outcomes - serum reactive protein-C - serum interleukin-6 ### Location - Facility: Zhongshan Hospital Fudan University, Shanghai, Shanghai, 200032, China @@
## Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS - NCT ID: NCT06387823 - Study ID: K5321 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-27 - Completion Date: 2025-09-01 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description The goal of this clinical trial is to evaluate the efficacy and safety of Sivelestat sodium and dexamethasone in the treatment of patients with moderate to severe ARDS. The main questions it aims to answer are:* Is Sivelestat sodium more effective in the treatment of patients with moderate to severe ARDS compared with placebo?* Is dexamethasone more effective in the treatment of patients with moderate to severe ARDS compared with placebo? Participants will receive Sivelestat sodium, dexamethasone or placebo. Researchers will compare the efficacy and safety of Sivelestat sodium, dexamethasone and placebo. ### Conditions - Acute Respiratory Distress Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sivelestat sodium - Dexamethasone - Sivelestat sodium placebo - Dexamethasone placebo ### Outcomes Primary Outcomes - 28-day ventilator-free days - Informed consent rate - Recruitment rate - Recruitment compliance rate - Protocol adherence rate - Completion of follow-up visits Secondary Outcomes - 28-day mortality - 90-day mortality - 28-day length of stay - 28-day organ support free day - Sequential organ failure assessment (SOFA) - Murray's acute lung injury score - C-reactive protein (CRP) - Interleukin-6 (IL-6) - Interleukin-8 (IL-8) - Procalcitonin (PCT) - Neutrophil-to-lymphocyte Ratio (NLR) - Neutrophil elastase - New-onset infection rate - Re-intubation rate - Adverse event ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Irinotecan Liposome II in Combination With 5-FU/LV and Oxaliplatin in Perioperative Treatment of Borderline Resectable Pancreatic Cancer - NCT ID: NCT06387810 - Study ID: MA-PC-II-010 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-17 - Completion Date: 2026-06-30 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of irinotecan liposome II in combination with oxaliplatin and 5-FU/LV in perioperative treatment of borderline resectable pancreatic cancer in 45 patients. ### Conditions - Borderline Resectable Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - irinotecan liposome II combined with 5-FU/LV and oxaliplatin ### Outcomes Primary Outcomes - event free survival Secondary Outcomes - overall survival - R0 resection rate - R1 excision rate - adverse event ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Primary and Secondary Prevention of Type 2 Diabetes Mellitus in Clark County - NCT ID: NCT06387797 - Study ID: UNLV-2023-321 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-05-31 - Lead Sponsor: University of Nevada, Las Vegas ### Study Description This pilot and feasibility study aims to assess the effectiveness of a nutrition education intervention using the Cooking Matters for Adults Curriculum (SNAP-Ed). The study compares this standard curriculum with an enhanced version that includes the same curriculum but has additional components, incorporating specific information related to type 2 diabetes. Additionally, participants in the enhanced group will receive continuous glucose monitors to wear during the study for 10 days. The primary outcomes of the study include evaluating the acceptability of the intervention, and the feasibility of conducting the intervention at the UNLV Nutrition Center. The investigators will also assess participants' Knowledge, Attitudes, and Intentions regarding produce consumption. Alongside feasibility and acceptability, the study aims to explore the preliminary effectiveness of the intervention in increasing fruit and vegetable consumption, reducing HbA1c, managing cardiometabolic risk, and improving gut microbiome composition and diversity among participants in the program. The investigators will also assess changes in other lifestyle behaviors from baseline to post-intervention (6 weeks) (sleep, stress, physical activity, and sedentary behavior). ### Conditions - At Risk for Type 2 Diabetes Mellitus - Pre Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Cooking Matters for Adults (CMA+) - Cooking Matters for Adults (CMA) ### Outcomes Primary Outcomes - Feasibility of conducting the intervention - Acceptability of the intervention - Acceptability of each cooking class Secondary Outcomes - Knowledge about the importance of produce consumption - Attitudes toward produce consumption - Intentions to consume recommended amounts of produce during and after intervention - Changes in fruit and vegetable consumption in servings per day - HbA1c% - Body weight in kg - Gut Microbiota composition - waist circumference in cm - body fat percentage (%) - non fat mass in kg ### Location - Facility: University of Nevada, Las Vegas, Las Vegas, Nevada, 89154, United States @@
## Acute Beetroot Juice Supplementation in Pre-eclampsia Pregnancies - NCT ID: NCT06387784 - Study ID: 2024/823 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-06 - Lead Sponsor: University of Sao Paulo ### Study Description Pre-eclampsia is a serious condition that typically affects pregnant women after the 20th week of pregnancy, characterized by high blood pressure and damage to organs such as the kidneys and liver. Currently, treatment options are limited, which has prompted researchers to explore alternative approaches. One such promising alternative is dietary nitrate found in vegetables like beetroot, as nitrate can be converted into nitric oxide in the body, which helps lower blood pressure. This study aims to determine the acute effects of nitrate-rich beetroot juice on blood pressure, several blood and salivary markers in pregnant women with pre-eclampsia. Furthermore, the study will assess fetal blood flow using Doppler ultrasound. The investigators want to understand the kinetics of nitrate and nitric oxide metabolites and assess the temporal dependency of the hypotensive response. Through this investigation, the investigators seek evidence of nitrate-enriched beetroot juice as an adjunct therapy in managing pre-eclampsia. ### Conditions - Pre-Eclampsia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Beetroot juice - Placebo juice ### Outcomes Primary Outcomes - Acute Effect of Beetroot Juice Supplementation on Blood Pressure Secondary Outcomes - Plasma Concentrations of Nitric Oxide Metabolites - Concentration of Salivary Nitrate Reductase Enzyme - Plasma Lipid Peroxidation Levels - Concentration of Total Antioxidant Capacity in Plasma - Maternal Blood Flow Velocity - Fetal Heart Rate - Umbilical Arterial Pulsatility Index ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of Tolcapone as a Cognitive Enhancer in Schizophrenia - NCT ID: NCT06387771 - Study ID: rs4680-tolcapona - Status: RECRUITING - Start Date: 2014-09-22 - Completion Date: N/A - Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra ### Study Description Objective: To assess the efficacy of tolcapone to improve cognition in schizophrenia, as a genotype-based targeted treatment of cognitive and negative symptoms of schizophrenia considering the polymorphism rs4680.Methodology: 20 patients with chronic and stabilized schizophrenia (10 patients with genotype Val/Val and 10 patients with genotype Met/Met according to polymorphism rs4680) will receive treatment with tolcapone during 7 days. The cognitive function and clinical status will be evaluated with a neuropsychological battery and appropriate clinical scales before and after treatment. The efficiency of the activation of the prefrontal cortex will be measured using functional magnetic resonance imaging (fMRI) before and after treatment.Hypothesis: Only patients with genotype Val/Val treated with tolcapone would show a cognitive improvement, a higher efficiency of the activation of the prefrontal cortex and an amelioration of some negative symptoms. ### Conditions - Schizophrenia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Tolcapone ### Outcomes Primary Outcomes - Efficacy: Change from baseline in cognitive test scores at day 8 - Efficacy: Change from baseline in the brain blood-oxygen-level-dependent (BOLD) response at day 8 Secondary Outcomes - Efficacy: change from baseline in psychotic symptoms intensity measured by the PANSS scores at day 8 - Efficacy: negative symptoms intensity: change from baseline in the 16-item Negative Symptom Assessment (NSA-16) scale scores at day 8 - Efficacy: change from baseline in the intensity of psychotic symptoms measured by the Brief Psychiatric Rating Scale (BPRS) scores at day 8 - Efficacy: change from baseline in the clinical global impression measured by the Clinical Global Impression (CGI) scale scores at day 8 - Efficacy: change from baseline in the global assessment of functioning measured by the Global Assessment of Functioning (GAF) scale scores at day 8 - Efficacy: change from baseline in the anxiety symptoms measured by the Hamilton Anxiety Rating Scale (HAM-A) scale scores at day 8 - Efficacy: change from baseline in the depressive symptoms measured by the Hamilton Depression Rating Scale (HAM-D) scale scores at day 8 - Efficacy: change from baseline in the Clinician-Rated Dimensions of Psychosis Symptom Severity (CRDPSS) scale scores at day 8 - Change from baseline in plasmatic homocysteine (umol/L) ### Location - Facility: Clinica Universidad de Navarra, Pamplona, Navarra, 31008, Spain @@
## Low Systemic/High Local Exercise Load in Peds SCD - NCT ID: NCT06387758 - Study ID: UMMC-IRB-2022-473 - Status: RECRUITING - Start Date: 2023-09-19 - Completion Date: 2025-06-30 - Lead Sponsor: University of Mississippi Medical Center ### Study Description This research study wants to learn about what kind of exercise is best for kids with sickle cell disease. Participating children will have a small amount of blood drawn one time at the beginning of the study. Children will then complete some questionnaires that measure pain, physical function, and emotions (depression, anxiety) and complete some tests that measure physical fitness at the beginning and end of the study. Children will be randomized to either a home-based telehealth (1) walking or (2) strengthening exercise program that lasts for 8-weeks, 3-x week, for 45 minutes each session. Children's participation will last up to 10 weeks. ### Conditions - Sickle Cell Anemia in Children ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Low systemic strength training - Moderate systemic exercise ### Outcomes Primary Outcomes - Demographics and medical history (parents) - Pediatric Pain Questionnaire - Functional Disability Inventory - NIH PROMIS 2582 - Heart Rate Variability - Heart Rate - Blood Pressure - Bruininks-Oseretsky Test of Motor Proficiency - American Thoracic Society 6-minute walk test - Actigraphy - Daily diaries - Biomarkers - Medical Chart Review Secondary Outcomes ### Location - Facility: University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States @@
## Referral of Patients to Hepatology With Hepatoscope - NCT ID: NCT06387745 - Study ID: US-REFERRAL - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-12 - Lead Sponsor: University Hospital, Antwerp ### Study Description Patients identified as being at risk of liver fibrosis because of a positive Fibrosis-4 (FIB-4) test in the primary care setting will be offered be enrolled in the trial and to undergo an Hepatoscope exam (external non-invasive ultrasound imaging exam) to screen for liver fibrosis (with stiffness measurements) and/or steatosis (with ultrasound parameters related to fatty liver). All patients presenting with a liver stiffness value of at least 6.5 kilopascal (kPa) will be referred to the tertiary hepatology consultations for further assessment. Hepatoscope measurements will be compared to the standard of care for these patients, as defined at the tertiary hepatology center. ### Conditions - Chronic Liver Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Hepatoscope ### Outcomes Primary Outcomes - Positive Predictive Value for significant fibrosis Secondary Outcomes - Correlation of stiffness measurements - Concordance of stiffness measurements - Diagnostic performance of liver stiffness measurements ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Mechanisms Underlying Antidepressant Effects of Physical Activity - NCT ID: NCT06387732 - Study ID: 161223 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2028-01 - Lead Sponsor: University College, London ### Study Description It is well established that any level of physical activity can help prevent and treat depression, with more strenuous activity having a greater effect. Understanding the mechanisms driving this antidepressant effect is important because it could allow exercise programmes to be made more effective, accessible, and targeted. Such knowledge could contribute to social prescribing, increasingly a priority for mental healthcare. Importantly, physical activity is highly scalable, low cost, well suited to early intervention, and has beneficial impacts on physical health co-morbidities. This trial may provide initial indications of whether there are sub-groups of depressed individuals who are particularly likely to benefit from physical activity, lead to strategies to personalise physical activity prescription based on motivational factors, and pave the way for augmentative approaches, for example combining physical activity with psychological interventions.To date the mechanisms driving the antidepressant effects of physical activity in humans are poorly understood. Building on links between depressive symptoms, reward processing and dopamine, plus evidence from animal studies that physical activity is anti-inflammatory and boosts both dopamine and reward processing, the overarching aim of this trial is to understand the mechanisms underlying the effects of physical activity in depression, focusing on the concept of motivation.The key objective is to conduct a randomised controlled trial (RCT) in N=250 depressed participants comparing aerobic exercise to a stretching/relaxation control condition, examining a range of mechanistic factors. The proposed trial will examine the impact of physical activity at multiple, linked potential levels of explanation: (1) immune-metabolic markers; (2) dopamine synthesis capacity; (3) activation in the brain's reward and effort processing circuitry;(4) effort-based decision making incorporating computational analysis; and (5) symptom networks based on fine-grained, daily measurements. ### Conditions - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Aerobic exercise - Stretching and relaxation ### Outcomes Primary Outcomes - Patient Health Questionnaire-9 score Secondary Outcomes - Physical activity - Aerobic capacity: CPET - Ecological Momentary Assessment - Inflammatory response (cytokines) - Inflammatory response (genetic markers) - Inflammatory response (flow cytometry immunophenotype) - Neuroendocrine system - Metabolic function - Dopamine synthesis capacity - Functional magnetic resonance imaging (fMRI) during cognitive tasks - Online cognitive tasks - Depression symptoms - Anxiety (GAD7 score) - Anxiety (STAI score) - Anhedonia (SHAPS score) - Anhedonia (DARS score) - Apathy - Fatigue - Cognitive impairment - Self-efficacy - Self-esteem - Sleep quality ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Precursors of Binge Eating Disorder in a Clinical Sample of Adolescents With Obesity - NCT ID: NCT06387719 - Study ID: PREC-BED Study - Status: RECRUITING - Start Date: 2023-07-21 - Completion Date: 2026-05 - Lead Sponsor: Fundació Sant Joan de Déu ### Study Description BACKGROUND: Binge eating disorder (BED) is the worldwide most-prevalent eating disorder. It is associated with psychiatric comorbidities and obesity, a high impact in life functioning, and high morbidity and mortality. First symptoms appear frequently in youths, who most commonly present incomplete (subthreshold) criteria for BED (precursor forms, PREC-BED). While some subjects will evolve from PREC-BED to BED, there is no gold standard to identify the clinical evolution. Information from prior studies suggest early alterations in reward and inhibitory brain circuits in PREC-BED may predict increased vulnerability or resilience to develop BED. Tools based on MRI brain connectivity analyses (MRI-BC), built on robust and interpretable connectivity whole-brain models, have proven successful in diagnostic classification and predicting certain clinical outcomes. OBJECTIVES: To study MRI-BC diagnostic markers of PREC-BED and to explore prognosis at 1 year of follow-up in a sample of adolescents with obesity (12-17 years old). METHODS: A) Transversal analytical design: 3-group (n=34 per group) comparison of neuroimaging (MRI-BC), neurocognitive and clinical markers in adolescents with obesity and i) BED, ii) PREC-BED, iii) no BED nor PREC-BED (Healthy group, HC). B) Longitudinal analytical design, pilot, exploratory: adolescents with PREC-BED will be evaluated in clinical and neurocognitive variables at 1 year. Baseline brain neuroimaging variables (alone and in combination with clinical and neurocognitive variables) will be analyzed as predictors of clinical prognosis, including conversion to BED. ### Conditions - Binge-Eating Disorder - Obesity - Eating Disorders - BED - Other Specified Feeding or Eating Disorder - Eating Disorder Nos - Emotion Regulation - Food Addiction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Magnetic resonance imaging ### Outcomes Primary Outcomes - Neuroimaging assessment - Neuroimaging assessment Secondary Outcomes - Height - Weight - Waist perimeter - BMI - Blood pressure - Fasting glucose - Triglycerides - HDL cholesterol - Developmental Tanner stage - Adherence to Mediterranean diet - Diagnosis of BED, and PREC-BED or exclusion of other DMS-5 diagnosis. - Functioning - Depression - Anxiety - Emotion Regulation - Eating symptomatology - Eating symptomatology - Temperamental tendencies for sensitivity to punishment and sensitivity to reward. - Food Addiction - Food intake - General Intelligence - Attention ability - Visuo-constructional ability and visual memory - Executive function: cognitive flexibility, alternating attention, sequencing, visual search, and motor speed. - Executive function: working memory ability - Executive function: decision-making abilities reward based - Executive function: ability to inhibit cognitive interference - Executive function: planning and strategic organisation ### Location - Facility: Hospital Sant Joan de Déu, Esplugues De Llobregat, Barcelona, 08950, Spain @@
## The Development of a Gamified Web-based Pain Management Program (GAP) for Community-dwelling Older Adults With Chronic Pain - NCT ID: NCT06387706 - Study ID: GAP - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2024-11-30 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description Pain Management in Older Adults: Pain significantly impacts the well-being of older adults, often leading to diminished physical abilities and a reduced quality of life. Despite this, pain management remains suboptimal, with concerns about medication side effects and a tendency to view pain as a natural aspect of aging. Consequently, many seniors are hesitant to use painkillers. As an alternative, non-pharmacological strategies such as educational programs, physical activity, massage, relaxation techniques, and music therapy are gaining traction.Innovative Non-Drug Solutions: To improve participation in non-medication pain relief methods, we suggest incorporating gaming elements into these programs (GAP). Originating in digital media in 2008, gamification has since spread across various industries. It involves adding game-like elements to activities to boost engagement, experience, and motivation.Project Goals: The aims of this initiative include creating a web-based Gamified Pain Management Program (GAP), engaging older adults with chronic pain in the development of GAP, and gathering their feedback on the program's effectiveness. ### Conditions - Chronic Pain Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Gamified web-based pain management Program ### Outcomes Primary Outcomes - Pain Relief Secondary Outcomes ### Location - Facility: Hong Kong Metropolitan University, Hong Kong, N/A, N/A, Hong Kong @@
## Artificial Intelligence in ANOCA - NCT ID: NCT06387693 - Study ID: 24U-1359 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2028-12 - Lead Sponsor: UMC Utrecht ### Study Description Angina pectoris is diagnosed in \>180.000 people in the Netherlands each year. Diagnosis in angina pectoris focuses on epicardial coronary stenosis, the identification of which may lead to guideline-directed medical therapy or revascularization. However, no such stenosis is identified in 40-70% of patients. This condition, angina with no obstructed coronary artery (ANOCA), is more prevalent in women and is related to poor quality of life, high medical expenses, and a higher incidence of adverse events.The origin of ANOCA can be evaluated during invasive coronary angiography by coronary function testing (CFT) to identify coronary vasomotor disorders. This relates to vasospasm of the coronary artery and microcirculation, or to impaired microvascular vasodilation. For the diagnosis of vasospasm, CFT needs to result in electrocardiographic signs of myocardial ischemia as part of the diagnostic criteria. This is a critical point in the diagnosis of vasospasm, as these signs can be subtle and can vary, and are therefore prone to misinterpretation. Apart from this caveat, the diagnosis approach therefore currently requires an invasive procedure for the diagnosis. This limits the broad application and hampers early identification and treatment of ANOCA.During CFT, a coronary guide wire is routinely advanced in the coronary artery which also allows obtaining an intracoronary ECG by attaching a sterile alligator clamp to a standard electrocardiogram lead. This allows continuous recording of intracoronary ECG throughout CFT on the same monitor as the routine ECG. This technique can increase sensitivity for myocardial ischemia during CFT. Further, Holter ECG monitoring allows the identification of ischemic changes in the ECG in the outpatient setting. Evidence is lacking on the patterns of myocardial ischemia that occur during spontaneous angina pectoris symptoms in ANOCA patients, and on the sensitivity of Holter ECG for this purpose. Finally, the interpretation of ischemic patterns on ECG tracings can be cumbersome, especially when changes are subtle or change from beat to beat. The use of deep learning techniques allows to automate the interpretation of ECG traces and may improve the standardized diagnosis in ANOCA. ### Conditions - Angina, Stable ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Holter monitoring, intracoronary ECG ### Outcomes Primary Outcomes - Prevalence of myocardial ischemia in patients with equivocal coronary function test results - Diagnostic accuracy of perprocedural Holter ECG monitoring to diagnose coronary vasomotor disorders - Diagnostic ccuracy of outpatient Holter monitoring for coronary vasomotor disorders Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Peanut Ball Use on Labor - NCT ID: NCT06387680 - Study ID: 2022/187 - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2024-04-01 - Lead Sponsor: Selcuk University ### Study Description The purpose of this study was to evaluate the effect of using peanut balls during labor on labor memory, labor satisfaction, labor length, and neonatal APGAR scores. ### Conditions - Birth Outcome, Adverse - Birth, First - Labor Long - Apgar; 4-7 at 1 Minute ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - The Effect of Peanut Ball Use on Labor Memory, Labor Satisfaction, Delivery Length, and Neonatal APGAR Score: A Randomized Controlled Trial ### Outcomes Primary Outcomes - Comparison of sociodemographic of pregnant women. - Comparison of obstetric characteristics of pregnant women - Comparison of postpartum characteristics of pregnant women - Comparison of duration of 1st and 2nd stage of labor by group - Comparison of 1st and 5th minute APGAR scores of newborns by group - Comparison of the mean scores of the Pregnant Women's Birth Memory and Recall Questionnaire (BirthMARQ) and its subscales by groups - Comparison of pregnant women's Birth Satisfaction Scale (BSS) mean scores by groups Secondary Outcomes ### Location - Facility: Selcuk University, Konya, N/A, 42250, Turkey @@
## Characterizing Diversity and Antifungal Resistance in Immunocompromised ICU Patients With Respiratory Tract Infections - NCT ID: NCT06387667 - Study ID: FIRTI - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-06-01 - Lead Sponsor: New Valley University ### Study Description Immunocompromised individuals face a heightened risk of life-threatening fungal infections, which arise from a multitude of environmental and commensal fungi. Surveillance data from ICUs worldwide identifies Candida spp. as the dominant foe, responsible for 80% of such infections, earning it the dubious distinction of being the third most prevalent pathogen. While C. albicans holds the dubious crown as the most common Candida offender, recent years have witnessed a concerning trend toward non-Albicans candida, raising concerns about potential antifungal resistance. ### Conditions - Immunocompromised ICU Patients With Respiratory Tract Infections ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Complete blood count - C-reactive protein, urea, creatinine, Random blood glucose (RBG), aspartate aminotransferase (AST), alanine aminotransferase (ALT) - CT chest - Microscopic examination - culture and sensitivity ### Outcomes Primary Outcomes - Number of fungal species causing pneumonia in immunocompromised ICU patients Secondary Outcomes - Determine the antifungal susceptibility profiles of the identified fungal isolates. - Number of associated specific patient factors with the type or antifungal resistance of fungal infections ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinico-biological Collection of Autoimmune, Dysimmune or Auto-inflammatory Dermatological Diseases - NCT ID: NCT06387654 - Study ID: RC31/23/0361 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2034-04 - Lead Sponsor: University Hospital, Toulouse ### Study Description The aim of this project is to start a biological and clinical collection of patients presenting autoimmune, dysimmune or auto-inflammatory dermatological diseases. This collection will provide appropriate biological samples to identify new biomarkers and to be accessible to the medical, scientific and industrial communities for the identification of new therapeutic strategies. ### Conditions - Autoimmune Bullous Dermatosis - Systemic Autoimmune Diseases With Dermatological Presentation - Dysimmune Dermatological Diseases - Auto-inflammatory Dermatological Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood sampling - Remainders of samples taken as part of the treatment ### Outcomes Primary Outcomes - Building a collection of biological samples and clinical-biological data from patients with autoimmune, dysimmune or auto-inflammatory dermatological disease Secondary Outcomes - Identification of new autoantibodies - Identification of biomarkers regarding the severity (such as cytokines, survival factors) in order to help the therapeutic decisions - Exploration of the pathophysiological mechanisms of rare autoimmune dermatological pathologies - Comparison of blood cells populations determinants with flow cytometry, before and after cell therapy and in patients responder or not responder to cell therapy ### Location - Facility: Purpan University Hospital, Toulouse, N/A, 31059, France @@
## Effects of Life Review Intervention on Meaning in Life Among Older Adults With Disabilities - NCT ID: NCT06387641 - Study ID: 2024004 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-25 - Completion Date: 2025-01-01 - Lead Sponsor: Bao Huimin ### Study Description The goal of this interventional study is to learn if life review works to improve the sense of meaning in life in older adults with disabilities who live at home. The main questions it aims to answer are:Does life review enhance the sense of meaning in life of participants? Dose life reviews enhance the life satisfaction of participants. Dose life reviews enhance the quality of life of participants?Researchers will compare the life review program to routine community health services to see if the life review intervention program is effective in enhancing the sense of meaning in life of older adults with disabilities who live at home.Participants will:Take face-to-face life review interview or routine community health service every week for 6 weeks.Take the the questionnaire survey before and after the six-week life review intervention. ### Conditions - Disabilities, Psychological ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Life review - Routine community health services ### Outcomes Primary Outcomes - Change from Baseline in Meaning in life on the Meaning in Life Questionnaire (MLQ) at Week6 Secondary Outcomes - Change from Baseline in Life satisfaction on the Life Satisfaction In-dex A (LSIA) at Week6 - Change from Baseline in Quality of life on the 12-Item Short Form Survey (SF-12) at Week6 ### Location - Facility: Xixi Street Community Health Service Center, Hanzhou, Zhejiang, 310012, China @@
## LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer - NCT ID: NCT06387628 - Study ID: LM108-IIT-202 - Status: RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-04-01 - Lead Sponsor: Fudan University ### Study Description To evaluate the efficacy and safety of LM108 plus toripalimab plusnab-paclitaxel or eribulin as first-line or post-line treatment in patients with metastatic triple-negative breast cancer. ### Conditions - TNBC - Triple-Negative Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - LM-108 - Toripalimab - Eribulin - Nab paclitaxel ### Outcomes Primary Outcomes - ORR Secondary Outcomes - DoR - DCR - PFS - OS - Adverse events ### Location - Facility: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China @@
## Impact of Non-invasive Brain Stimulation on Learning Novel Spoken Words - NCT ID: NCT06387615 - Study ID: H22086 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-12-31 - Lead Sponsor: Georgia State University ### Study Description The purpose of the proposed study is to use transcranial magnetic stimulation (TMS) to evaluate a neurobiological model of spoken word learning in older youth. Specifically, it is hypothesized that: (1) inhibition of the left dorsal stream will impact subsequent learning, processing, and retention of phonologically similar pseudowords; (2) the impact of dorsal stream inhibition on word learning will be associated with baseline levels of variability in neural activity, indicative of underlying differences in cortical excitability. ### Conditions - Dyslexia - Dyslexia, Developmental - Learning; Developmental Disorder, Reading ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Active cTBS - Sham ### Outcomes Primary Outcomes - Novel Word Learning Task - Pseudoword Discrimination Task Secondary Outcomes - MRI Scan ### Location - Facility: Georgia State University/Georgia Tech Center for Advanced Brain Imaging (CABI), Atlanta, Georgia, 30318, United States @@
## Comparison Between Effects of Active Release Technique and Post Isometric Relaxation on Adductor Strain in Mixed Martial Arts Fighters - NCT ID: NCT06387602 - Study ID: FUI/CTR/2024/6 - Status: RECRUITING - Start Date: 2023-07-15 - Completion Date: 2024-11-20 - Lead Sponsor: Foundation University Islamabad ### Study Description This study is a randomized controlled trial and the purpose of this study is to compare the effects between active release technique and post-isometric relaxation on adductor strain in mixed martial arts fighters. ### Conditions - Adductor Strain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cryotherapy - Strengthening of adductors - Active release technique - Post-Isometric Relaxation ### Outcomes Primary Outcomes - Pain Intensity - Range of motion - Functionality - Flexibility Secondary Outcomes ### Location - Facility: Foundation University College of Physical Therapy, Rawalpindi, Punjab, 46000, Pakistan @@
## Effects of Static Stretching Versus Post Facilitation Stretch of Iliopsoas in Non-Specific Low Back Pain - NCT ID: NCT06387589 - Study ID: FUI/CTR/2024/5 - Status: RECRUITING - Start Date: 2023-07-15 - Completion Date: 2024-06-20 - Lead Sponsor: Foundation University Islamabad ### Study Description This study is a randomized controlled trial and the purpose of this study is to determine the effects of Static Stretching Versus Post Facilitation Stretch of Iliopsoas combined with core stability exercises in Non-Specific Low Back Pain" ### Conditions - Low Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Core stability exercises - Static Stretching of Iliopsoas - Post Facilitation Stretch of Iliopsoas ### Outcomes Primary Outcomes - Pain intensity - Level of disability - Lumbar Range of motion - Hip Range of motion Secondary Outcomes ### Location - Facility: Foundation University College of Physical Therapy, Rawalpindi, Punjab, 46000, Pakistan @@
## Post-Discharge Follow-up Appointment Scheduling - NCT ID: NCT06387576 - Study ID: Post-discharge Appointments - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2024-06 - Lead Sponsor: University of California, Los Angeles ### Study Description This is a prospective clinical trial evaluating whether a behaviorally informed intervention (pre-discharge iPad video scheduling) increases post-discharge primary care physician (PCP) appointment completion compared to the status-quo scheduling process (post-discharge via phone), with the ultimate goal of improving patient health outcomes. ### Conditions - Appointments and Schedules ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Behaviorally informed pre-discharge iPad video scheduling ### Outcomes Primary Outcomes - Post-discharge follow-up PCP appointment completion rate within 7 days Secondary Outcomes - Post-discharge follow-up PCP appointment completion rate within 14 days - Post-discharge follow-up PCP appointment scheduling rate within 7 days ### Location - Facility: UCLA Santa Monica Medical Center, Santa Monica, California, 90404, United States @@
## Effects of Abdominal Muscle Activation Training, Using Pressure Biofeedback in Comparison With Surface Electromyography - NCT ID: NCT06387563 - Study ID: FUI/CTR/2024/4 - Status: RECRUITING - Start Date: 2023-11-06 - Completion Date: 2024-05-30 - Lead Sponsor: Foundation University Islamabad ### Study Description This study is a randomized control trial and the purpose of this study to determine the effects of abdominal muscle activation training on non-specific low back pain; using pressure biofeedback in comparison with surface electromyography biofeedback: a randomized control trial. ### Conditions - Low Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Abdominal activation using pressure biofeedback - Abdominal activation using SEMG biofeedback ### Outcomes Primary Outcomes - Pain Intensity - Level of Disability Secondary Outcomes ### Location - Facility: Foundation University College of Physical Therapy, Rawalpindi, Punjab, 46000, Pakistan @@
## Effects of Eccentric Training on Glycemic Control and Quality of Life in Patients With Type II Diabetes Mellitus - NCT ID: NCT06387550 - Study ID: FUI/CTR/2024/3 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-07-15 - Lead Sponsor: Foundation University Islamabad ### Study Description Diabetes is defined by the level of hyperglycemia its a metabolic chronic disorder that furthur lead to life threatning medical conditions however, the prevalence of diabetes is rapidly increasing day by day in both developed and developing countries making it global pandemic and type II is more prevalent. Life dependency is increased due to long term effects of diabetes in specifically older individuals. Physical activity and exercise improves glucose tolerance and also reduces other life threatening diabetic complications, improving the quality of life in diabetic population. ### Conditions - Type II Diabetes Mellitus ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Eccentric Training ### Outcomes Primary Outcomes - Glycemic control - Patient's quality of life Secondary Outcomes ### Location - Facility: Foundation University College of Physical Therapy, Rawalpindi, Punjab, 46000, Pakistan @@
## Effects of Scapular Mobilization on Shoulder Proprioception and Pain in Patients With Adhesive Capsulitis - NCT ID: NCT06387537 - Study ID: FUI/CTR/2024/2 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-07-15 - Lead Sponsor: Foundation University Islamabad ### Study Description Adhesive capsulitis is a common musculoskeletal condition. Painful gradual loss of both active and passive gleno-humeral motion resulting from progressive fibrosis and ultimate contracture of the gleno-humeral joint capsule.Scapular position and movement perception both effected by shoulder adhesive capsulitis, change in the scapular kinematics in the form of an increase in scapular lateral rotation, and reduced joint sense for shoulder movements in adhesive capsulitis. Physiotherapists have a wide range of options in managing Adhesive capsulitis including Electrotherapeutic modalities, kaltenborn mobilization, Maitland's mobilization,Mulligan's mobilization and Manipulation. So far studies have shown the efficacy of different treatments in combination or in isolation.Few studies on proprioception in rotator cuff tear, sub acromial impingment syndrome, but no obseved effects of scapular mobilization on shoulder proprioception in patients with adhesive capsulitis.Physical therapist focus on lowering pain and ROM limitations in the shoulder,but often neglect to evaluate proprioception/joint position sense as well as the roleof scapula in adhesive capsulitis during treatment.If found effective,this study can help in probviding treatment protocols for improving proprioception in patients with adhesive capsulits. ### Conditions - Adhesive Capsulitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Conventional physical therapy - Scapular mobilization. ### Outcomes Primary Outcomes - Shoulder Proprioception - Pain Intensity Secondary Outcomes - Shoulder Range of motion - Shoulder Disability ### Location - Facility: Foundation University College of Physical Therapy, Rawalpindi, Punjab, 460000, Pakistan @@
## Effects of Eccentric Exercises on Gait Parameters in Patellofemoral Pain Syndrome: A Quasi-Experimental Study - NCT ID: NCT06387524 - Study ID: FUI/CTR/2024/1 - Status: RECRUITING - Start Date: 2023-07-15 - Completion Date: 2024-11-20 - Lead Sponsor: Foundation University Islamabad ### Study Description This study is a quasi experimental and the purpose of this study is to determine the effects of eccentric exercises on gait parameters in patellofemoral pain syndrome: a quasi - experimental study ### Conditions - Patellofemoral Pain Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - McConnell Taping - ECCENTRIC EXERCISES: ### Outcomes Primary Outcomes - Dynamic knee valgus angle - Hip Range of Motion - Knee Range of Motion - Pain intensity - Gait Speed - Cadence - Stride length - Step length - Cycle length Secondary Outcomes ### Location - Facility: Foundation University College of Physical Therapy, Rawalpindi, Punjab, 46000, Pakistan @@
## Increasing Measles Vaccination Coverage Through Supplementation With an SQ-LNS Incentive in Children Aged 6-23 Months - NCT ID: NCT06387511 - Study ID: NutriVax-Measles - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-06-15 - Lead Sponsor: Alliance for International Medical Action ### Study Description Provision of SQ-LNS also holds promise in incentivizing vaccination as well as other health services.We will estimate 1) the effectiveness of a SQ-LNS mass supplementation program added to routine immunization program compared to routine immunization program alone in terms of measles vaccine coverage, after 12 months of program implementation, 1) in children aged 12-23 months in the endline cross-sectional household survey, 2) in children aged 6-12 months at inclusion in a longitudinal 12 months follow-up survey.Secondary objectives are to assess the barriers and facilitators from the perspectives of parents/legal guardian of children, health care providers and community health workers and to assess the cost-efficiency of theThis study will implrmented in 20 wards covering the Karasuwa and Nguru Local Government Areas (LGAs) in Yobe state, Northeast Nigeria.This is a pragmatic parallel cluster randomized trial (PCT) with baseline measure with different populations and data collection modes: 1) baseline and endline cross-sectional household surveys of children aged 12-23 months, 2) a longitudinal follow-up survey (LS) of children aged 6-12 months at inclusion, 3) a qualitative feasibility and acceptability survey of parents of children aged 6-23 months, of health providers, of community health workers and community representatives and 4) a cost survey of parents/legal guardian of children from the longitudinal follow-up cohort, and 5) a health facility cost survey of a randomized sub-sample of health facilities.Clusters will be randomly allocated at a ratio of 1:1 either to the standard arm or to the NutriVax arm:* The standard Expanded Program on Immunization (EPI) in children aged 6-23 months delivered according to the Ministry of Health's routine plans in the community and at health centres and health posts, named the standard EPI arm;* The NutriVax program combining the EPI in children aged 6-23 months according to the Ministry of Health's routine plans in the community and at health centres (i.e. PHCCs) and health posts associated with SQ-LNS mass supplementation integrated into pre-existing services delivered at health centres (i.e. PHCCs) for children 6-23 months of age, named the NutriVax arm. ### Conditions - Immunization Coverage Improvment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Small-quantity lipid-based nutrition supplements (SQ-LNS) NutriVax ### Outcomes Primary Outcomes - Measles vaccine coverage in children aged 12-23 months - Measles vaccine coverage in children 6-12 months at inclusion Secondary Outcomes - Measles vaccine coverage: at least one dose - Measles vaccine coverage : two doses - Timeliness of measles 1 vaccination - Other infant vaccines coverage - Zero-dose - Fully immunization - Acceptability - Cost-efficiency ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Testicular Tissue Cryopreservation (TTC) - NCT ID: NCT06387498 - Study ID: 20-2286 - Status: RECRUITING - Start Date: 2020-09-28 - Completion Date: 2027-12-30 - Lead Sponsor: University of Colorado, Denver ### Study Description The "Testicular Tissue Cryopreservation" study is open to a subset of patients facing disease or treatment regimens that could lead to infertility (gonadotoxic therapies). For some of these patients, experimental testicular tissue cryopreservation is the only fertility preservation option available. The overall objective of this study is to determine the feasibility and acceptability of testicular tissue cryopreservation in male patients of all ages who have a condition or will undergo a treatment that can cause infertility. ### Conditions - Fertility Issues ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Testicular tissue biopsy and cryopreservation ### Outcomes Primary Outcomes - Feasibility, as Assessed via the Percentage of Eligible Patients who do a Procedure - Feasibility, as Assessed via Percentage of Patients who Attempted a Procedure who were able to Cryopreserve - Safety, as Assessed via the Number of Participants with At Least One Pre-specified Adverse Event - Safety, as Assessed via the Number of Participants with At Least One Pre-specified Adverse Event - Safety, as Assessed via the Number of Participants with At Least One Pre-specified - Safety, as Assessed via the Number of Participants with At Least One Pre-specified Secondary Outcomes - Acceptability, as Assessed via Annual Survey Regret Score ### Location - Facility: University of Colorado, Aurora, Colorado, 80045, United States @@
## A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning - NCT ID: NCT06387485 - Study ID: SR-001 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-04-01 - Lead Sponsor: Ricoh USA, Inc. ### Study Description This prospective, multi-center, randomized controlled study aims to assess the efficacy of utilizing 3D printed models in preoperative planning for the excision of tumors involving bony structures within the body. The study is expected to last approximately 12 months and involve up to 150 subjects across 3 sites. Subjects will be randomized in a 1:1 ratio into either the experimental arm, utilizing 3D printed models and imaging, or the active comparator arm, using only imaging.Primary endpoint: Operative time of surgical procedure.Secondary endpoints: Reduction of blood loss, proportion of postoperative adverse events, and negative tumor margins.Exploratory endpoints: Surgical planning ease, changes in surgical plan, and surgeon satisfaction. ### Conditions - Sarcoma, Ewing - Chondrosarcoma - Osteosarcoma - Fibrous Histiocytoma - Fibrosarcoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 3D Printed Anatomic Model - CT/MRI ### Outcomes Primary Outcomes - Operative time Secondary Outcomes - Blood loss - Adverse Events - Tumor margin status ### Location - Facility: William Beaumont University Hospital, Royal Oak, Michigan, 48073, United States @@