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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 conditions: Lipid Testing conditions: Myocardial Infarction studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Lipid panel measure: Variation in LDL measure: Variation in non-HDL and apoB measure: Evaluation of intensification threshold measure: Repeat lipid panel after discharge measure: Evaluation of intensification threshold after discharge sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montreal Heart Institute city: Montréal state: Quebec zip: H1T 1C8 country: Canada name: Guillaume Marquis-Gravel, MD, MSc role: CONTACT phone: (514) 376-3330 email: guillaume.marquis.gravel@umontreal.ca name: Guillaume Marquis-Gravel, MD, MSc role: PRINCIPAL_INVESTIGATOR name: Jean Grégoire, MD role: SUB_INVESTIGATOR name: François Simard, MD role: SUB_INVESTIGATOR name: Rafaël Monet-Alarcia, MD role: SUB_INVESTIGATOR lat: 45.50884 lon: -73.58781 hasResults: False |
<|newrecord|> nctId: NCT06388655 id: MDCR-19-007 briefTitle: The Effect of the Mobile EEG-Neurofeedback in Healthy Child and Adolescent overallStatus: COMPLETED date: 2019-06-10 date: 2022-06-30 date: 2022-06-30 date: 2024-04-29 date: 2024-04-29 name: Daegu Catholic University Medical Center class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 61 type: ACTUAL name: mobile neurofeedback name: sham mobile neurofeedback measure: Comparisons of the means of children's self-scale variables measure: Comparisons of the means of parents' self-scale variables : Beck Depression Inventory-II (BDI-II) measure: Comparisons of the means of parents' self-scale variables : Beck Anxiety Inventory (BAI) measure: Comparisons of the means of children's K-WISC-IV(Korean Wechsler Intelligence Scale for Children-IV) measure: Comparisons of the means of children's Stroop measure: Comparisons of the means of children's ATA(Advanced Test of Attention) measure: Comparisons of the means of children's CCTT(Children's Color Trails Test) sex: ALL minimumAge: 8 Years maximumAge: 15 Years stdAges: CHILD facility: Daegu Catholic University Medical Center city: Daegu state: Nam-gu zip: 42471 country: Korea, Republic of lat: 35.87028 lon: 128.59111 hasResults: False |
<|newrecord|> nctId: NCT06388642 id: CUV052 briefTitle: Pharmacokinetics of Afamelanotide in EPP Patients overallStatus: RECRUITING date: 2024-03-07 date: 2024-07-01 date: 2024-10-01 date: 2024-04-29 date: 2024-04-29 name: Clinuvel Europe Limited class: INDUSTRY briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 28 type: ESTIMATED name: Afamelanotide 16mg implant measure: Cmax (maximum Plasma Concentration) measure: AUC(0-t) (area under the curve from administration to last observed concentration at time t) measure: AUC(0-∞) (area under the curve extrapolated to infinite time) sex: ALL minimumAge: 12 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus Medical Center status: RECRUITING city: Rotterdam country: Netherlands name: Erasmus Medical Centre role: CONTACT lat: 51.9225 lon: 4.47917 hasResults: False |
<|newrecord|> nctId: NCT06388629 id: M064-066 Rev 00 briefTitle: Epicardial Access Study With Rook acronym: EASY-R overallStatus: RECRUITING date: 2023-12-17 date: 2024-05 date: 2024-05 date: 2024-04-29 date: 2024-04-29 name: Circa Scientific, Inc. class: INDUSTRY briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, non-randomized primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: Rook Epicardial Access Kit measure: Successful Epicardial Access measure: Speed of Access measure: Rate of Use Errors measure: Rate of Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Na Homolce Hospital status: RECRUITING city: Prague zip: 15030 country: Czechia name: Petr Neuzil, MD, PhD role: CONTACT phone: +420257272211 lat: 50.08804 lon: 14.42076 hasResults: False |
<|newrecord|> nctId: NCT06388616 id: D6402C00013 briefTitle: Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2024-11-15 date: 2024-11-15 date: 2024-04-29 date: 2024-04-29 name: AstraZeneca class: INDUSTRY briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Three cohorts (two hepatic impairment cohorts and controls with normal hepatic function) will be enrolled into this study. |
All subjects will receive the study intervention: |
* Cohort 1 will enroll 8 participants with mild hepatic impairment |
* Cohort 2 will enroll 8 participants with moderate hepatic impairment |
* Cohort 3 will enroll 8-12 healthy participants matched on a group level regarding age, BMI and sex primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Balcinrenone measure: Area under plasma concentration-time curve from time zero to the last measurable concentration (AUClast) measure: Area under plasma concentration-time curve from zero to infinity (AUCinf) measure: Maximum observed plasma concentration (Cmax) measure: AEs and SAEs up to the follow-up telephone call (Day 10 [± 3 days]) measure: Number of participants with abnormal Vital signs, abnormal ECGs, and abnormal physical examination findings measure: Number of participants with abnormal laboratory tests results sex: ALL minimumAge: 18 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site city: Hialeah state: Florida zip: 33014 country: United States lat: 25.8576 lon: -80.27811 facility: Research Site city: Orlando state: Florida zip: 32809 country: United States lat: 28.53834 lon: -81.37924 facility: Research Site city: San Antonio state: Texas zip: 78215 country: United States lat: 29.42412 lon: -98.49363 hasResults: False |
<|newrecord|> nctId: NCT06388603 id: DFORCT012023 briefTitle: RCT on Bioactive Glass S53P4 in Diabetic Foot Osteomyelitis in the Forefoot (DFORCT) acronym: DFORCT overallStatus: RECRUITING date: 2024-03-21 date: 2026-09-30 date: 2026-12-30 date: 2024-04-29 date: 2024-04-29 name: ASST Ovest Milanese class: OTHER name: Hippocrates Research name: Bonalive Biomaterials Ltd briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 140 type: ESTIMATED name: Bioactive Glass name: Standard of Care measure: healing rate measure: Duration of antibiotic therapy measure: Rate of recurrences measure: Number of re-interventions because of the same lesion measure: Timing of re-interventions because of the same lesion measure: Proportion of patients undergoing amputations measure: Patients' Quality of Life measure: Patients' Quality of Life measure: Time back to walk measure: Characteristics of surgery measure: Length of surgery sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASUGI Azienda Sanitaria Universitaria Giuliano Isontina - Ospedale Monfalcone status: NOT_YET_RECRUITING city: Monfalcone state: Gorizia zip: 34074 country: Italy name: Dr. Roberto Da Ros, Med Doctor role: CONTACT phone: +39 3470606008 email: roberto.daros@aas2.sanita.fvg.it name: Dr. Roberto Da Ros, Med Doctor role: PRINCIPAL_INVESTIGATOR lat: 45.80463 lon: 13.53292 facility: ASST Ovest Milanese - Ospedale di Abbiategrasso status: RECRUITING city: Abbiategrasso state: Milano zip: 20081 country: Italy name: Dr. Roberto De Giglio, Med Doctor role: CONTACT phone: +39 331 6989775 email: roberto.degiglio@asst-ovestmi.it name: Dr. Roberto De Giglio, Med Doctor role: PRINCIPAL_INVESTIGATOR name: Dr. Ilaria Formenti, Med Doctor role: SUB_INVESTIGATOR name: Dr. Vincenzo Curci, Med Doctor role: SUB_INVESTIGATOR lat: 45.39821 lon: 8.91678 facility: Casa di Cura Abano Terme - POLICLINICO ABANO TERME status: NOT_YET_RECRUITING city: Abano Terme state: Padova zip: 35031 country: Italy name: Dr. Christine Whisstock, Med Doctor role: CONTACT phone: +39 338 8924624 email: cwhisstock@casacura.it name: Dr. Christine Whisstock, Med Doctor role: PRINCIPAL_INVESTIGATOR lat: 45.35753 lon: 11.78725 facility: USL Sud Est Toscana - Ospedale San Donato status: NOT_YET_RECRUITING city: Arezzo zip: 52100 country: Italy name: Dr. Alessia Scatena, Med Doctor role: CONTACT phone: +39 328 3281501 email: alessia.scatena@uslsudest.toscana.it name: Dr. Alessia Scatena, Med Doctor role: PRINCIPAL_INVESTIGATOR name: Dr. Matteo Apicella, Med Doctor role: SUB_INVESTIGATOR lat: 43.46276 lon: 11.88068 facility: AUSL Romagna - Ospedale Morgagni Pierantoni status: NOT_YET_RECRUITING city: Forlì zip: 47121 country: Italy name: Dr. Silvia Acquati, Med Doctor role: CONTACT phone: +39 335 1239344 email: silvia.acquati@auslromagna.it name: Dr. Silvia Acquati, Med Doctor role: PRINCIPAL_INVESTIGATOR lat: 44.22177 lon: 12.04144 facility: Azienda USL Toscana Nord Ovest - Ospedale Campo di Marte status: NOT_YET_RECRUITING city: Lucca zip: 55100 country: Italy name: Dr. Ilaria Casadidio, Med. Doctor role: CONTACT phone: +39 3284882078 email: ilaria.casadidio@uslnordovest.toscana.it name: Dr. Ilaria Casadidio, Med Doctor role: PRINCIPAL_INVESTIGATOR lat: 43.84369 lon: 10.50447 facility: AOU Pisana - Ospedale di Cisanello status: NOT_YET_RECRUITING city: Pisa zip: 5612 country: Italy name: Prof. Alberto Piaggesi, Med Doctor role: CONTACT phone: +39 3473331949 email: alberto.piaggesi@med.unipi.it name: Dr. Chiara Goretti, Med Doctor role: CONTACT phone: +39 3294125791 email: chiara.goretti@gmail.com name: Prof. Alberto Piaggesi, Med Doctor role: PRINCIPAL_INVESTIGATOR name: Dr. Chiara Goretti, Med Doctor role: SUB_INVESTIGATOR lat: 43.70853 lon: 10.4036 hasResults: False |
<|newrecord|> nctId: NCT06388590 id: MOMMC.2024.0029 briefTitle: Acupuncture for Chronic Pelvic Pain overallStatus: RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-29 date: 2024-04-29 name: David Moss class: FED briefSummary: 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 conditions: Acupuncture conditions: Gynecology studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Patient sample will be both control and treatment groups. Individuals will not be divided into distinct groups. Patients will serve as their own controls. Control patients will be participating in standard of care therapies including physical therapy, psychotherapy, behavioral health, typical primary care management, etc. as deemed appropriate by the primary care provider for 4 weeks prior to study intervention. The same patients will then be re-evaluated and will be offered Acupuncture with Dragon technique (see attachment Protocol for Needle Insertion) as a means of pain control once per week for 4 weeks. primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Dragons name: Standard of Care measure: Defense and Veterans Pain Rating Scale (DVPRS) measure: Defense and Veterans Pain Rating Scale (DVPRS) measure: Defense and Veterans Pain Rating Scale (DVPRS) measure: Defense and Veterans Pain Rating Scale (DVPRS) measure: Defense and Veterans Pain Rating Scale (DVPRS) measure: Defense and Veterans Pain Rating Scale (DVPRS) measure: Female Genitourinary Pain Index (GUPI) measure: Female Genitourinary Pain Index (GUPI) measure: Female Genitourinary Pain Index (GUPI) measure: Female Genitourinary Pain Index (GUPI) measure: Female Genitourinary Pain Index (GUPI) measure: Female Genitourinary Pain Index (GUPI) measure: PTSD Checklist for DSM-5 (PCL-5) measure: PTSD Checklist for DSM-5 (PCL-5) measure: PTSD Checklist for DSM-5 (PCL-5) measure: PTSD Checklist for DSM-5 (PCL-5) measure: PTSD Checklist for DSM-5 (PCL-5) measure: PTSD Checklist for DSM-5 (PCL-5) sex: FEMALE minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mike O'Callaghan Military Medical Center status: RECRUITING city: Nellis Air Force Base state: Nevada zip: 89191 country: United States name: Amanda J Crawford, MSHS role: CONTACT phone: 702-653-3583 email: amanda.j.crawford.ctr@health.mil lat: 36.24607 lon: -115.05721 hasResults: False |
<|newrecord|> nctId: NCT06388577 id: MEU-HEM-SY-189 briefTitle: The Effect of the Training Programme Based on the Health Promotion Model Given to Parents overallStatus: NOT_YET_RECRUITING date: 2024-05-13 date: 2024-06-13 date: 2024-09-13 date: 2024-04-29 date: 2024-04-29 name: Mersin University class: OTHER briefSummary: 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 conditions: Epilepsy in Children conditions: Disease Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, single-centre, randomised controlled, single-blind interventional study in parallel groups primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Participants and the person who will perform the statistical analysis will be blinded. Participants will be assigned to intervention and control groups coded as A and B. Afterwards, it will be determined which of the A and B groups belong to the control and intervention groups by drawing lots.It will not be explained to the parents which group they are in, and it will be stated that education about epilepsy will be given. While entering the data, the researcher will enter the data encrypted as A and B in order to prevent measurement bias, the statistical analysis of the data will be carried out according to this encryption and the report of the study will be written in encrypted form. After the statistical analyses of the research are carried out and the research report is written as a result of the data found, it will be explained which of the groups the individuals are included in. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: Education measure: Parents' level of knowledge about epilepsy evaluated using the Form for the Evaluation of Parents' Level of Knowledge about Epilepsy measure: Self-efficacy evaluated using the General Self-Efficacy Scale measure: Health Promoting and Protective Behaviors evaluated using the Health Promoting and Protective Behaviors Scale measure: Number of Hospital Admissions for Children evaluated using the Evaluation Form for the Number of Hospital Admissions sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Turkey, Mersin University city: Mersin country: Turkey name: Sümerya YASTI, MASTER role: CONTACT email: 2204160171012@mersin.edu.tr name: Hacer ÇETİN, PROFESSOR role: PRINCIPAL_INVESTIGATOR lat: 36.79526 lon: 34.61792 hasResults: False |
<|newrecord|> nctId: NCT06388564 id: INCA34176-254 id: 2022-502168-19-00 type: REGISTRY domain: EU CT Number briefTitle: A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease overallStatus: NOT_YET_RECRUITING date: 2024-07-08 date: 2027-03-05 date: 2028-09-05 date: 2024-04-29 date: 2024-04-29 name: Incyte Corporation class: INDUSTRY briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Axatilimab name: Ruxolitinib name: Corticosteroids measure: Objective Response Rate measure: Number of participants with Treatment-emergent Adverse Events (TEAEs) measure: Duration of Response measure: Proportion of participants with a ≥ 7-point improvement in modified Lee symptom scale (mLSS) score measure: Best overall response in the first 6 months measure: OR at 12 months, defined as CR or PR at 12 months (C14D1) in the absence of new systemic therapy for cGVHD. measure: Proportion of participants who remain corticosteroid-free measure: 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. measure: Failure-free Survival (FFS) measure: Axatilimab pharmacokinetic (PK) in Plasma measure: Ruxolitinib PK in Plasma sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06388551 id: LY03017/CT-CHN-101 briefTitle: A Phase 1, SAD Study to Evaluate the Safety and Tolerability of LY03017 overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2025-03-30 date: 2025-03-30 date: 2024-04-29 date: 2024-04-29 name: Luye Pharma Group Ltd. class: INDUSTRY briefSummary: 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 conditions: Hallucinations and Delusions Associated With Parkinson Disease Psychosis conditions: Negative Symptoms of Schizophrenia studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: LY03017 name: LY03017-Placebo measure: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) measure: Maximum observed concentration (Cmax) of LPM526000133 in plasma measure: Time to maximum observed concentration (Tmax) of LPM526000133 in plasma measure: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM526000133 in plasma measure: Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of LPM526000133 in plasma measure: Apparent terminal elimination half-life (t1/2) of LPM526000133 in plasma sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Shanghai Mental Health Center city: Shanghai country: China name: Huafang Li role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06388538 id: Carlo Bergamini briefTitle: The COLD2B Multicenter, Two-arm Prospective Cohort Study acronym: COLD2B overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-05-01 date: 2025-06-01 date: 2024-04-29 date: 2024-04-29 name: Azienda Sanitaria di Firenze class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Conservative treatment (non-operative treatment) name: Surgical treatment (operative treatment) measure: Length of hospital stay in the overall population measure: Morbidity rate for both arms measure: Mortality rate for both arms measure: Surgical complications rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dipartimento di Medicina di Precisione e Rigenerativa e Area Jonica (DiMePRe-J), Universita' di Bari city: Bari country: Italy name: Francesco Paolo Prete role: CONTACT lat: 41.11148 lon: 16.8554 facility: Department of Emergency and Acceptance, Emergency Surgery Unit, Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy city: Florence zip: 50134 country: Italy name: Carlo Bergamini, MD role: CONTACT phone: +39(0)557949173 email: drcarlobergamini@gmail.com name: Carlo Bergamini role: PRINCIPAL_INVESTIGATOR name: Alessio Giordano role: PRINCIPAL_INVESTIGATOR lat: 43.77925 lon: 11.24626 facility: Department of Medicine, Surgery and Health Sciences, University of Trieste city: Trieste country: Italy name: Manuela Mastronardi role: CONTACT lat: 45.64953 lon: 13.77679 facility: Department of General Surgery, PO di Vittorio Veneto (TV), ULSS2 Marca Trevigiana city: Vittorio Veneto country: Italy name: Giulia Montori role: CONTACT lat: 45.98026 lon: 12.30065 hasResults: False |
<|newrecord|> nctId: NCT06388525 id: PostERCPLC briefTitle: Post-ERCP Cholecystectomy. How ERCP and ERCP-related Variables Effect the Outcomes? overallStatus: COMPLETED date: 2016-01-01 date: 2020-01-01 date: 2020-01-01 date: 2024-04-29 date: 2024-04-29 name: Kanuni Sultan Suleyman Training and Research Hospital class: OTHER briefSummary: 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 conditions: ERCP-Laparoscopic Cholecystectomy Interval conditions: Number of Preoperative ERCPs conditions: Stone Extraction Status in ERCP Procedures conditions: Biliary Stents conditions: Mechanical Lithotripsy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 426 type: ACTUAL name: Endoscopic Retrograde Cholangiopancreatography measure: Conversion to open measure: Subtotal Cholecystectomy measure: Postoperative Complications measure: Adhesion levels measure: Operative time measure: Length of hospital stay sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bakirkoy Dr. Sadi Konuk Training and Research Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06388512 id: STUDY00160044 briefTitle: iMRI Prone Positioning Frame Design Feasibility Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-29 date: 2024-04-29 name: University of Kansas Medical Center class: OTHER name: Continuum Educational Technologies briefSummary: 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 conditions: Pulmonary Embolism studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 5 type: ESTIMATED name: prototype prone positioning device measure: Number of devices that meet functional requirements measure: Number of devices that are damaged during use measure: Number of patients with skin complications measure: Number of patients with thromboembolic complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Kansas Medical Center city: Kansas City state: Kansas zip: 66160 country: United States name: Andrew Guillotte, MD role: CONTACT phone: 309-648-7036 email: aguillotte@kumc.edu name: Anand Dharia, MD role: SUB_INVESTIGATOR name: Jennifer Cheng, MD role: SUB_INVESTIGATOR name: Michael Kinsman, MD role: PRINCIPAL_INVESTIGATOR name: Christopher Miller, MD role: SUB_INVESTIGATOR lat: 39.11417 lon: -94.62746 hasResults: False |
<|newrecord|> nctId: NCT06388499 id: GOIPG/2022/1854 briefTitle: A Physiotherapy-led Disease-agnostic Telerehabilitation Programme for People With Chronic Health Conditions overallStatus: RECRUITING date: 2024-04-16 date: 2024-07-22 date: 2024-07-31 date: 2024-04-29 date: 2024-04-29 name: University of Limerick class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: TECC (Telerehabilitation and Exercise for Chronic Conditions) measure: Recruitment rate assessed by number of participants recruited during recruitment period. measure: Retention rate assessed by the proportion of enrolled participants who complete post-intervention assessments. measure: Adherence rate assessed by the attendance at synchronous group exercise sessions measure: Satisfaction with the intervention as assessed by the Client-Satisfaction Questionnaire 8 (CSQ-8) measure: Satisfaction with individual intervention components assessed by Numerical Rating Scales (NRS) measure: Adverse events assessed via self-report questionnaire measure: Intervention acceptability as assessed by qualitative feedback from participants via focus groups measure: Physical function assessed by the 30-second chair stand test (30CST). measure: Quality of life assessed by the Euro-QoL 5 Dimension 5 Level (Euro-QoL-5D-5L). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: South Tipperary Chronic Disease Management Hub, St. Brigid's Hospital, Carrick-on-Suir status: RECRUITING city: Tipperary country: Ireland name: Niamh Julian, BSc role: CONTACT lat: 52.47333 lon: -8.15583 hasResults: False |
<|newrecord|> nctId: NCT06388486 id: UMCGoettingen9/9/16 briefTitle: Cytokine-Induced Transcription in Depressed Inpatients Undergoing Psychotherapy acronym: CitDip overallStatus: COMPLETED date: 2017-01-01 date: 2022-03-09 date: 2024-01-01 date: 2024-04-29 date: 2024-04-29 name: University Medical Center Goettingen class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 63 type: ACTUAL name: Psychotherapy measure: Change in depression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06388473 id: NMRR-20-2188-56086 IIR briefTitle: Implementation of a Web-based App for Screening in Men in a Malaysian Primary Care Setting acronym: iScreenMen overallStatus: COMPLETED date: 2021-01-14 date: 2021-06-06 date: 2021-06-06 date: 2024-04-29 date: 2024-04-29 name: University of Malaya class: OTHER briefSummary: 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 conditions: Implementation conditions: Web-based Application studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 101 type: ACTUAL name: Tailored implementation intervention measure: Reach measure: Reach measure: Adoption of ScreenMen using qualitative methods measure: Implementation of ScreenMen using qualitative methods measure: Maintenance of ScreenMen using qualitative methods measure: Impact of COVID-19 on the clinic using qualitative methods sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Klinik Kesihatan Cheras Baru city: Kuala Lumpur zip: 56100 country: Malaysia lat: 3.1412 lon: 101.68653 hasResults: False |
<|newrecord|> nctId: NCT06388460 id: STUDY00001015 id: R01HL169229 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL169229 briefTitle: Asthma Link Effectiveness Trial: Cluster Randomized Controlled Trial overallStatus: RECRUITING date: 2024-04-04 date: 2028-01 date: 2028-04 date: 2024-04-29 date: 2024-04-29 name: University of Massachusetts, Worcester class: OTHER name: National Institutes of Health (NIH) name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 350 type: ESTIMATED name: Asthma Link name: Enhanced Usual Care measure: Improving Asthma Symptoms measure: Improving Medication Adherence measure: Improving Healthcare Utilization measure: Reducing Parental Lost Workdays measure: Reducing School Absences measure: Improving Quality of Life sex: ALL minimumAge: 5 Years maximumAge: 14 Years stdAges: CHILD facility: University of Massachusetts Chan Medical School status: RECRUITING city: Worcester state: Massachusetts zip: 01655 country: United States name: Michelle Spano role: CONTACT phone: 508-856-2990 email: michelle.spano@umassmed.edu name: MIchelle Trivedi, MD MPH role: PRINCIPAL_INVESTIGATOR lat: 42.26259 lon: -71.80229 hasResults: False |
<|newrecord|> nctId: NCT06388447 id: UCMSC1 briefTitle: Reconstruction of Deficient Interdental Papilla Using Stem Cells vs Physiological Saline: a RCT overallStatus: ENROLLING_BY_INVITATION date: 2023-12-01 date: 2024-12-31 date: 2025-03-30 date: 2024-04-29 date: 2024-04-29 name: University of Malaya class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Umbilical cord-mesenchymal stem cells measure: Reconstruction of the deficient interdental papilla with soft tissue measure: Reconstruction of the deficient interdental papilla with bone measure: Reconstruction of the deficient interdental papilla with bone sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Orthodontic Postgraduate Clinic city: Kuala Lumpur state: Wilayah Persekutuan Kuala Lumpur zip: 50603 country: Malaysia lat: 3.1412 lon: 101.68653 hasResults: False |
<|newrecord|> nctId: NCT06388434 id: HP-00100309 briefTitle: Protective Arm Balance Responses acronym: PAT overallStatus: RECRUITING date: 2023-10-01 date: 2024-07 date: 2024-08 date: 2024-04-29 date: 2024-04-29 name: University of Maryland, Baltimore class: OTHER briefSummary: 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 conditions: Peripheral Neuropathy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: The study will include two groups (older adults and people with peripheral neuropathy) which will be assessed pre- and post-intervention primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Protective Arm Balance Response Training measure: Grasp Accuracy measure: In-task falls incidence measure: Electromyography (EMG) of the shoulder muscles measure: Physiological responses (heart rate variability) measure: Physiological responses (electrodermal activity) measure: Activity specific balance confidence scale measure: Stait Trait Anxiety Inventory measure: Subjective Units of Distress Scale measure: Mini Mental State Examination (MMSE) measure: Beck Anxiety Inventory measure: Somatosensation sex: ALL minimumAge: 45 Years maximumAge: 88 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Allied Health Research Building status: RECRUITING city: Baltimore state: Maryland zip: 21201 country: United States name: Kelly P Westlake, PhD role: CONTACT phone: 410-706-5919 email: kwestlake@som.umaryland.edu lat: 39.29038 lon: -76.61219 hasResults: False |
<|newrecord|> nctId: NCT06388421 id: GMS-PH-401 briefTitle: DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2030-08-01 date: 2030-11-30 date: 2024-04-29 date: 2024-04-29 name: United Therapeutics class: INDUSTRY briefSummary: 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 conditions: Pulmonary Hypertension conditions: Interstitial Lung Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Prospective study assessments measure: Baseline characteristics as described by demographics, medical history, ILD history, PH history, family history (comorbidities), and diagnostic right heart catheterization values measure: Changes in clinical features relating to patients' interstitial lung disease and pulmonary hypertension sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06388408 id: SufMAST briefTitle: Effects of Sufentanil Target Controlled Infusion on Patient State Index Values and Electroencephalographic Spectrum During Total Intravenous Anesthesia With Propofol overallStatus: NOT_YET_RECRUITING date: 2024-05-05 date: 2024-09-15 date: 2024-09-30 date: 2024-04-29 date: 2024-04-29 name: University of Padova class: OTHER briefSummary: 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 conditions: Sufentanil conditions: Target Controlled Infusion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Effects of Sufentanil on Patient State index (PSi) during stable Propofol general anesthesia measure: Effects of Sufentanil on Electroencephalogram (EEG) power spectrum during stable Propofol general anesthesia measure: Effects of Sufentanil on Analgesia Nociception Index (ANI) during stable Propofol general anesthesia measure: Analgesia Nociception Index (ANI) values and postoperative pain measure: Patient State Index (PSi) values and postoperative delirium measure: Analgesia Nociception Index (ANi) values and postoperative delirium sex: FEMALE minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Treviso Regional Hospital city: Treviso state: TV zip: 31100 country: Italy lat: 45.66673 lon: 12.2416 hasResults: False |
<|newrecord|> nctId: NCT06388395 id: REC-23-05-12-02-F briefTitle: Clinical Performance of All-on-4 PEEK and Conventional Prostheses overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-06-30 date: 2027-08-30 date: 2024-04-29 date: 2024-04-29 name: University of Sharjah class: OTHER briefSummary: 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 conditions: Dental Prosthesis, Implant-Supported conditions: Survival, Prosthesis conditions: Complete Edentulism conditions: Complication;Prostheses studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups will be provided with two types of implant-supported prostheses primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Block randomization will be used to randomly assign participants. The sequences will be concealed in opaque, consecutively numbered envelopes for each block. One envelope will be obtained for each participant, corresponding to the assignment of the protocol (conventional versus PEEK). The outcome assessor will be independent and not involved in any treatment procedure whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Accuracy of full-arch surgical guides name: Survival and complications of the prostheses name: Survival and complications of the implants name: Conventional (metal-resin) implant-supported prosthesis name: PEEK implant-supported prosthesis measure: Accuracy of full-arch surgical guides measure: Survival rate of implants measure: Success rates of the Prostheses measure: Pain level measure: Marginal bone loss measure: Plaque index measure: Pocket depth measure: Bleeding index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Sharjah city: Sharjah zip: 7724 country: United Arab Emirates lat: 25.33737 lon: 55.41206 hasResults: False |
<|newrecord|> nctId: NCT06388382 id: UKKx2024 briefTitle: Investigation of the Audible ICD Alert Tone overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-05-15 date: 2025-05-30 date: 2024-04-29 date: 2024-04-29 name: Universitätsklinikum Köln class: OTHER briefSummary: Ability of ICD patients to hear the audible ICD alert is being assessed. conditions: Implantable Defibrillator User studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Alert tone demonstration measure: Alert tone audible sex: ALL minimumAge: 15 Years maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Cologne city: Cologne zip: 50937 country: Germany lat: 50.93333 lon: 6.95 hasResults: False |
<|newrecord|> nctId: NCT06388369 id: CA184-608 briefTitle: Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer acronym: NEPI overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-03 date: 2028-09 date: 2024-04-29 date: 2024-04-29 name: University Hospital, Essen class: OTHER name: Advanced Accelerator Applications name: Bristol-Myers Squibb briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The first patients are enrolled - without randomization - into the Safety Cohort to assess whether the treatment regime under investigation, i.e. Ipilimumab (3mg/kg) + \[177Lu\]Lu-PSMA-617 RLT (7,4 GBq), is appropriately tolerated as per dose escalation algorithm. |
If it is established that Ipilimumab (3mg/kg) + \[177Lu\]Lu-PSMA-617 RLT (7,4 GBq) is appropriately tolerated, patients will be randomized into the two arms of the Analysis Cohort: |
* Arm A: Ipilimumab + \[177Lu\]Lu-PSMA-617 RLT |
* Arm B: \[177Lu\]Lu-PSMA-617 RLT primaryPurpose: TREATMENT masking: NONE count: 58 type: ESTIMATED name: [177Lu]Lu-PSMA-617 name: Ipilimumab measure: Feasibility to perform prostatectomy on time measure: Clinical activity: Proportion of participants in the full analysis set who achieve a pCR measure: Safety Profile of neoadjuvant treatment before radical prostatectomy measure: Safety Profile of neoadjuvant treatment before radical prostatectomy sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Essen, Clinic of Urology city: Essen zip: 45147 country: Germany name: PD Dr. med. Ulrich Krafft role: CONTACT email: ulrich.krafft@uk-essen.de lat: 51.45657 lon: 7.01228 hasResults: False |
<|newrecord|> nctId: NCT06388356 id: 042024 briefTitle: Patient's Informational Privacy in Prehospital Emergency Care - Educational Intervention Study for the Paramedics overallStatus: ENROLLING_BY_INVITATION date: 2024-03-25 date: 2024-05-19 date: 2024-06-16 date: 2024-04-29 date: 2024-04-29 name: Eini Koskimies class: OTHER briefSummary: 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 conditions: Attitude of Health Personnel studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups, intervention and control group. Only intervention group is receiveing the intervention. primaryPurpose: BASIC_SCIENCE masking: NONE count: 50 type: ESTIMATED name: Educational intervention - Yksityisyyttä ensihoitoon / Informational privacy for preospital emergency care measure: Paramedics' knowledge about patient's informational privacy measure: paramedics' attitude towards patient's informational privacy. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Turku city: Turku zip: 20520 country: Finland lat: 60.45148 lon: 22.26869 hasResults: False |
<|newrecord|> nctId: NCT06388343 id: S68485 briefTitle: Causes of Listening Difficulties in Children acronym: CLINIC overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2027-12 date: 2027-12 date: 2024-04-29 date: 2024-04-29 name: Universitaire Ziekenhuizen KU Leuven class: OTHER name: Universitair Ziekenhuis Brussel briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: PARTICIPANT count: 280 type: ESTIMATED name: Evaluation of Children's Listening and Processing Skills name: Multidisciplinary behavioral assessment measure: ECLiPS questionnaire measure: Behavioral measures sex: ALL minimumAge: 6 Years maximumAge: 14 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06388330 id: s61692 briefTitle: The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms acronym: FFD overallStatus: COMPLETED date: 2019-04-26 date: 2022-03-08 date: 2022-03-08 date: 2024-04-29 date: 2024-04-29 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: 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 conditions: FODMAP Diet studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE maskingDescription: open label strict diet phase blinded participant during reintroduction count: 32 type: ACTUAL name: low FODMAP diet measure: Improvement on gastrointestinal symptoms measure: Reintroduction period measure: Evaluation of the low FODMAP diet on IBS related symptoms measure: Evaluation of the low FODMAP diet on symptom response and quality of life measure: Evaluation of the low FODMAP diet on depression, somatization measure: Evaluation of the low FODMAP diet on duodenal barrier function measure: Evaluation of the low FODMAP diet on gastric emptying measure: Evaluation of the low FODMAP diet on gastric accommodation sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: KU Leuven city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium lat: 50.87959 lon: 4.70093 hasResults: False |
<|newrecord|> nctId: NCT06388317 id: 123632 briefTitle: Machine-based Algorithm for Increased Physical Activity and Sustained User Engagement overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-01 date: 2025-01-01 date: 2025-02-01 date: 2024-04-29 date: 2024-04-29 name: Western University, Canada class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Retrospective, quasi-experimental study. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants are unaware of the other intervention arm (i.e., adaptive step goals versus static step goals). whoMasked: PARTICIPANT count: 500 type: ESTIMATED name: Adaptive Step Goal (Intervention) name: Static Step Goal (Control) measure: Step count measure: Number of app opens, total time spent on app, number of pages opened sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Western University city: London state: Ontario country: Canada lat: 42.98339 lon: -81.23304 hasResults: False |
<|newrecord|> nctId: NCT06388304 id: 23-0556 briefTitle: THRIVE Study: Positive Affect Training for Endocrine Therapy Medication Adherence acronym: THRIVE overallStatus: RECRUITING date: 2024-03-12 date: 2024-10-12 date: 2024-12-12 date: 2024-04-29 date: 2024-04-29 name: Joanna Arch class: OTHER briefSummary: 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 conditions: DCIS studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: THRIVE Online PAT Program measure: Acceptability of THRIVE intervention (AIM) measure: Feasibility of THRIVE intervention measure: Client Satisfaction Survey sex: FEMALE minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Boulder status: RECRUITING city: Boulder state: Colorado zip: 80309 country: United States name: Sienna Russel role: CONTACT phone: 720-897-1850 email: archlab@colorado.edu name: Madeline Nealis, MPH role: CONTACT phone: 720-897-1850 email: archlab@colorado.edu name: Joanna Arch, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.01499 lon: -105.27055 hasResults: False |
<|newrecord|> nctId: NCT06388291 id: CTU/2018/321 briefTitle: Deep Brain Stimulation in Tourette Syndrome acronym: Op-TICS overallStatus: RECRUITING date: 2022-08-02 date: 2025-01 date: 2025-06-30 date: 2024-04-29 date: 2024-04-29 name: University College, London class: OTHER name: National Institute for Health Research, United Kingdom name: University College London Hospitals name: Northern Care Alliance NHS Foundation Trust name: St George's University Hospitals NHS Foundation Trust name: Royal Devon and Exeter NHS Foundation Trust name: University of Bristol name: University of Dundee name: London School of Hygiene and Tropical Medicine name: King's College London name: University Hospital, Rouen name: Imperial College London briefSummary: 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 conditions: Deep Brain Stimulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: All participants will have electrodes implanted in the globus pallidus interna and connected to a subcutaneous pulse generator. |
This will be followed by a 6 months open-phase period of stimulation for electrical parameter adjustment. |
Following these 6 months, participants will be randomised into two groups by the order of treatment condition (ON/OFF-stimulation vs OFF/ON-stimulation): one group will be kept with the stimulation on ("ON-stimulation") and the other switched off ("OFF-stimulation") for up to two weeks. Tic severity will be assessed and all participants will enter a 2-day interval, in the ON state, before switching to the other treatment condition for another two weeks. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Double Blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Deep Brain Stimulation measure: 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 measure: MRVRS at the end of the OFF-stimulation state versus the end of the ON-stimulation state in the blinded, randomised crossover phase. measure: Change in the MRVRS between baseline 0 and the end of the open-phase (Baseline 1) measure: Change in the YGTSS (global) between baseline 0 and the end of the open-phase (Baseline 1) measure: Change in the GTS-QOL questionnaire measures at baseline 0 and the end of the open-phase (Baseline 1) measure: Change in the YBOCS between baseline 0 and the end of the open-phase (Baseline 1) measure: Change in the BDI scale between baseline 0 and the end of the open-phase (Baseline 1) measure: Change in the BAI scale between baseline 0 and the end of the open-phase (Baseline 1) measure: Change in the BAARS-IV between baseline 0 and the end of the open-phase (Baseline 1) measure: Safety of DBS as indicated by the number of participants with any adverse events and number with any serious adverse events measure: A mechanistic part of the study will look at possible explanations of differing responses in both the open and randomised phase. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Hospital of Neurology & Neurosurgery status: RECRUITING city: London country: United Kingdom name: Patricia Limousin role: CONTACT lat: 51.50853 lon: -0.12574 hasResults: False |
<|newrecord|> nctId: NCT06388278 id: NET-2018-12366982-4/ASP_LOMB briefTitle: Cost-effectiveness Analysis of an Antimicrobial Stewardship Program in Regione Lombardia (RF-net2018) acronym: RF-net2018 overallStatus: RECRUITING date: 2023-03-01 date: 2024-11-01 date: 2025-04-15 date: 2024-04-29 date: 2024-04-29 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER name: Regione Lombardia name: Ministero della Salute, Italy briefSummary: 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 conditions: Cost-effectiveness Analysis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 50000 type: ESTIMATED measure: evaluate the efficiency of the economic resources allocated to the antimicrobial stewardship program (AMS) through a cost-effectiveness analysis in patients with infection measure: 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. measure: compare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Fondazione Policlinico of Milan status: RECRUITING city: Milan zip: 20135 country: Italy name: GIULIA dr RENISI, Doctor role: CONTACT phone: 3887429609 email: giulia.renisi@policlinico.mi.it name: Alessandra dr Bandera, Doctor role: CONTACT phone: 0255034770 email: alessandra.bandera@unimi.it lat: 45.46427 lon: 9.18951 hasResults: False |
<|newrecord|> nctId: NCT06388265 id: 18/2018, Acta 26-6-2018 briefTitle: Emotional and Oral Characteristics of Patients That Attend a Dental Consultation for the Extraction of Third Molars overallStatus: COMPLETED date: 2022-01-09 date: 2023-07-31 date: 2023-07-31 date: 2024-04-29 date: 2024-04-29 name: University of Barcelona class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 75 type: ACTUAL name: Trifold information measure: Changes in STAI-S measure: Changes in MDAS measure: Changes in blood pressure measure: Changes in Heart rate measure: Changes in Oxygen saturation measure: Patient Satisfaction of procedure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Odontològic Universitat de Barcelona city: L'Hospitalet De Llobregat state: Barcelona zip: 08907 country: Spain lat: 41.35967 lon: 2.10028 hasResults: False |
<|newrecord|> nctId: NCT06388252 id: ERID-KSOPR-0049/2023 id: 0120-297/2023/3 type: OTHER domain: National Medical Ethics Committee of the Republic of Slovenia briefTitle: Electrochemotherapy Induces Changes in the Tumor Microenvironment of Cutaneous and Subcutaneous Metastases in Patients With Cutaneous Melanoma overallStatus: ENROLLING_BY_INVITATION date: 2023-11-10 date: 2025-09-30 date: 2025-11-30 date: 2024-04-29 date: 2024-04-29 name: Institute of Oncology Ljubljana class: OTHER name: Slovenian Research and Innovation Agency briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Electrochemotherapy with intratumoural cysplatin is recommended for smaller (less than 3 cm) and fewer tumours (up to 10 lesions), while electrochemotherapy with intravenous bleomycin is preferable for multiple and larger tumours. primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ESTIMATED name: Electrochemotherapy with Intratumoral Cysplatin name: Electrochemotherapy with Intravenous Bleomycin measure: Changes in the tumor microenvironment of cutaneoys and subcutaneousm melanoma metastases induced by electrochemotherapy measure: Diferrent changes in the tumor microenvironment induced by electrochemotherapy with bleomycin or cysplatin sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Oncology Ljubljana city: Ljubljana zip: 1000 country: Slovenia lat: 46.05108 lon: 14.50513 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-11-10 uploadDate: 2024-03-20T00:20 filename: ICF_000.pdf size: 356929 hasResults: False |
<|newrecord|> nctId: NCT06388239 id: BE24-006 briefTitle: Bioequivalence Study of Apixaban 5 mg Film-coated Tablets in Healthy Thai Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-08-26 date: 2024-09-14 date: 2024-09-23 date: 2024-04-29 date: 2024-04-29 name: International Bio service class: NETWORK briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Apixaban 5MG name: ELIQUIS measure: Plasma Area Under the Curve (AUC(0 to 36hr)) for Apixaban measure: Peak Plasma Concentration (Cmax) of Apixaban sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06388226 id: IRB # 16143 briefTitle: Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2026-07-31 date: 2026-07-31 date: 2024-04-29 date: 2024-04-29 name: Indiana University class: OTHER name: Purdue University briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Leg heat therapy name: Leg sham therapy measure: Change in time to exhaustion during treadmill exercise measure: Change in maximal pulmonary oxygen uptake during treadmill exercise measure: Change in triceps surae microvascular oxygenation during treadmill exercise measure: Change in systolic blood pressure measure: Change in diastolic blood pressure measure: Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score measure: Change in triceps surae microvascular oxygenation during reactive hyperemia measure: Change in triceps surae volume measure: Change in triceps surae intramuscular fat content measure: Change in the time constant for phosphocreatine recovery after dynamic exercise measure: Change in maximal plantar flexor strength sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06388213 id: GLP-1 RA patients GE by GUS briefTitle: 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. overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2026-05 date: 2024-04-29 date: 2024-04-29 name: University Hospital, Geneva class: OTHER briefSummary: 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 conditions: Anesthesia conditions: Pulmonary Aspiration of Gastric Contents studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Gastric Ultrasonography measure: Reduction of 5.5 cm2 of the CSA in patients pausing 7 days their GLP-1 RA treatment. measure: Correlation between a full stomach evaluated on gastric ultrasonography and gastric symptoms such as nausea and bloating. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06388200 id: OCU400-301 briefTitle: A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa acronym: liMeliGhT overallStatus: RECRUITING date: 2024-04-26 date: 2025-06-30 date: 2026-10-30 date: 2024-04-29 date: 2024-04-29 name: Ocugen class: INDUSTRY briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This is outcome assessor blinded study whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Sub-Retinal Administration of OCU400-301 measure: Number of participants with change in functional vision in the study eye of RP subjects as assessed by LDNA measure: Number of participants with change in functional vision in the study eye in Gene Agnostic group as assessed by LDNA measure: Number of participants with change in functional vision in the all treated eyes of RP subjects as assessed by LDNA measure: Number of participants with change in functional vision in the all treated eyes of subjects in Gene Agnostic Arm as assessed by LDNA measure: Number of participants with change in visual function in subjects with RHO mutation as assessed by LLVA letter score measure: Number of participants with change in visual function in Gene Agnostic Arm as assessed by LLVA letter scores measure: Ocular and non-ocular Events measure: Patients Global Impression of Change (PGIC) score sex: ALL minimumAge: 8 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Associated Retina Consultants status: RECRUITING city: Phoenix state: Arizona zip: 85020 country: United States name: Mallory Mintert, MS role: CONTACT phone: 480-999-5458 email: Mallory.mintert@doctrials.com name: Jillian Bollinger, BS role: CONTACT phone: 480-999-5458 email: Jillian.bollinger@doctrials.com name: Benjamin Bakall role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: Retina Consultants of Texas status: NOT_YET_RECRUITING city: Bellaire state: Texas zip: 77401 country: United States name: Rebbeca C Taing role: CONTACT phone: 713-524-3434 email: rebbecca.taing@retinaconsultantstexas.com name: Kenneth C Fan, M.D, MBA role: PRINCIPAL_INVESTIGATOR lat: 29.70579 lon: -95.45883 hasResults: False |
<|newrecord|> nctId: NCT06388187 id: NN9838-7749 id: U1111-1298-3451 type: OTHER domain: World Health Organization (WHO) id: 2023-509273-24 type: OTHER domain: European Medical Agency (EMA) briefTitle: A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight overallStatus: NOT_YET_RECRUITING date: 2024-06-24 date: 2026-02-27 date: 2026-04-10 date: 2024-04-29 date: 2024-04-29 name: Novo Nordisk A/S class: INDUSTRY briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Cagrilintide name: Semaglutide name: Placebo measure: Relative change in body weight measure: Achievement of ≥5% weight reduction measure: Achievement of ≥10% weight reduction measure: Achievement of ≥15% weight reduction measure: Achievement of ≥20% weight reduction measure: Change in waist circumference measure: Change in systolic blood pressure measure: Ratio to baseline in lipids: Total cholesterol measure: Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol measure: Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol measure: Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol measure: Ratio to baseline in lipids: Triglycerides measure: Ratio to baseline in lipids: Free fatty acids sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aurora FDRC Inc. city: Costa Mesa state: California zip: 92627 country: United States lat: 33.64113 lon: -117.91867 facility: Clinical Trial Res Assoc,Inc city: Plantation state: Florida zip: 33324 country: United States lat: 26.13421 lon: -80.23184 facility: Midwest Inst For Clin Res city: Indianapolis state: Indiana zip: 46260 country: United States lat: 39.76838 lon: -86.15804 facility: Accellacare city: Wilmington state: North Carolina zip: 28401 country: United States lat: 34.22573 lon: -77.94471 facility: Velocity Clinical Res-Dallas city: Dallas state: Texas zip: 75230 country: United States lat: 32.78306 lon: -96.80667 facility: Washington Cntr Weight Mgmt city: Arlington state: Virginia zip: 22206 country: United States lat: 38.88101 lon: -77.10428 facility: Capital Clin Res Ctr,LLC city: Olympia state: Washington zip: 98502 country: United States lat: 47.03787 lon: -122.9007 facility: Ocean West Research Clinic city: Surrey state: British Columbia zip: V3Z 2N6 country: Canada lat: 49.10635 lon: -122.82509 facility: Nova Scotia Health Authority city: Halifax state: Nova Scotia zip: B3H 1V7 country: Canada lat: 44.64533 lon: -63.57239 facility: Wharton Med Clin Trials city: Hamilton state: Ontario zip: L8L 5G8 country: Canada lat: 43.25011 lon: -79.84963 facility: Hospices Civils de Lyon-Hopital Lyon Sud-1 city: Pierre-Benite zip: 69310 country: France lat: 45.7009 lon: 4.82511 facility: Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1 city: Saint Herblain zip: 44800 country: France lat: 47.21765 lon: -1.64841 facility: Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1 city: Toulouse Cedex 9 zip: 31059 country: France lat: 43.60426 lon: 1.44367 facility: InnoDiab Forschung GmbH city: Essen zip: 45136 country: Germany lat: 51.45657 lon: 7.01228 facility: Wendisch/Dahl Hamburg city: Hamburg zip: 22607 country: Germany lat: 53.57532 lon: 10.01534 facility: AmBeNet GmbH city: Leipzig zip: 04107 country: Germany lat: 51.33962 lon: 12.37129 facility: Institut für Diabetesforschung GmbH Münster - Dr. med. Rose city: Münster zip: 48145 country: Germany lat: 51.96236 lon: 7.62571 facility: Forschungszentrum Ruhr KliFoCenter GmbH, Dr. med. Kahrmann city: Witten zip: 58455 country: Germany lat: 51.44362 lon: 7.35258 facility: The Health Centre city: Bradford-on-Avon zip: BA15 1DQ country: United Kingdom lat: 51.34772 lon: -2.25065 facility: Southmead Hospital city: Bristol zip: BS10 5NB country: United Kingdom lat: 51.45523 lon: -2.59665 facility: Addenbrooke's Hospital_Cambridge city: Cambridge zip: CB2 0QQ country: United Kingdom lat: 52.2 lon: 0.11667 facility: WISDEM Centre city: Coventry zip: CV2 2DX country: United Kingdom lat: 52.40656 lon: -1.51217 facility: The Staploe Medical Centre city: Soham zip: CB7 5JD country: United Kingdom lat: 52.33543 lon: 0.33654 facility: Joint Clinical Research Facility - Swansea city: Swansea zip: SA2 8PP country: United Kingdom lat: 51.62079 lon: -3.94323 hasResults: False |
<|newrecord|> nctId: NCT06388174 id: S2022-0336 briefTitle: Idiopathic Generalized Epilepsy Syndromes overallStatus: RECRUITING date: 2023-01-01 date: 2026-12-31 date: 2033-12-31 date: 2024-04-29 date: 2024-04-29 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: 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 conditions: Epilepsy, Idiopathic Generalized studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: The proportion of drug-resistent epilepsy measure: The proportion of seizure freedom measure: The proportion of psychiatric comorbidity measure: The proportion of psychosocial outcome measure: The proportion of seizure relapse after antiseizure medication withdrawn sex: ALL minimumAge: 4 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China status: RECRUITING city: Hangzhou state: Zhejiang zip: 310000 country: China name: Chunhong Shen role: CONTACT phone: +86 0571 87783872 email: shen_neurology@zju.edu.cn lat: 30.29365 lon: 120.16142 hasResults: False |
<|newrecord|> nctId: NCT06388161 id: Yan2022-0336 briefTitle: Neural Autoantibody Prevalence in New-onset Focal Seizures of Unknown Etiology overallStatus: RECRUITING date: 2023-08-01 date: 2025-12-31 date: 2030-12-31 date: 2024-04-29 date: 2024-04-29 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER name: Sir Run Run Shaw Hospital name: Ningbo Medical Center Lihuili Hospital name: Shaoxing People's Hospital briefSummary: 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 conditions: Encephalitis Autoimmune studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: Detectable serum neural autoantibodies measure: Neuronal surface antibodies-mediated autoimmune- encephalitis measure: The proportion of seizure freedom measure: The proportion of drug-resistent epilepsy measure: Clinical severity and recovery sex: ALL minimumAge: 14 Years maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China status: RECRUITING city: Hangzhou state: Zhejiang country: China name: Chun-Hong Shen role: CONTACT phone: +86 0571 87783872 email: shen_neurology@zju.edu.cn lat: 30.29365 lon: 120.16142 hasResults: False |
<|newrecord|> nctId: NCT06388148 id: XL STROKE-2 briefTitle: Endovascular Treatment for eXtra-Large Ischemic Stroke acronym: XL STROKE-2 overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-10-31 date: 2027-01-31 date: 2024-04-29 date: 2024-04-29 name: Zhongming Qiu class: OTHER name: The First Affiliated Hospital, University of South China name: Xiangtan Central Hospital name: Zhejiang University name: Longyan First Affiliated Hospital of Fujian Medical University briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 286 type: ESTIMATED name: Medical management name: Endovascular thrombectomy measure: Modified Rankin Scale score measure: Rate of successful reperfusion measure: Rate of excellent outcome measure: Rate of functional independence measure: Rate of independent ambulation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xiangtan Central Hospital city: Xiangtan state: Hunan zip: 421001 country: China lat: 27.85 lon: 112.9 facility: Xingguo County People's Hospital city: Ganzhou state: Jiangxi country: China hasResults: False |
<|newrecord|> nctId: NCT06388135 id: SNC-01 briefTitle: Serplulimab Combined With Nab-paclitaxel and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05 date: 2027-05 date: 2024-04-29 date: 2024-04-29 name: Yang Jianjun, PhD class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Serplulimab Combined With Nab-paclitaxel and Cisplatin name: nab-paclitaxel，Cisplatin measure: pCR measure: MPR measure: DFS measure: ORR measure: AEs sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06388122 id: 23-009689 id: NCI-2024-03405 type: REGISTRY domain: CTRP (Clinical Trials Reporting Program) id: MC240301 type: OTHER domain: Mayo Clinic briefTitle: DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Metastatic Breast Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2026-06-15 date: 2026-06-15 date: 2024-04-29 date: 2024-04-29 name: Mayo Clinic class: OTHER briefSummary: 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 conditions: Hormone-receptor-positive Breast Cancer conditions: Metastatic Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Biospecimen Collection measure: DiviTum®TKa assay as an early predictor of primary treatment resistance sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Florida city: Jacksonville state: Florida zip: 32224-9980 country: United States name: Clinical Trials role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Pooja Advani, MBBS, MD role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 hasResults: False |
<|newrecord|> nctId: NCT06388109 id: IRB15-00741 briefTitle: Positive Peers Intervention Clinical Trial acronym: PoPIT overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-05 date: 2027-11 date: 2024-04-29 date: 2024-04-29 name: MetroHealth Medical Center class: OTHER name: Kent State University briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized control trial with observational cohort for eligible patients who decline participation primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 250 type: ESTIMATED name: Positive Peers mobile app measure: Viral suppression measure: Correlates of app use and viral suppression measure: Correlates of app use and retention in care measure: Correlates of app use and HIV related perceived stigma sex: ALL minimumAge: 13 Years maximumAge: 34 Years stdAges: CHILD stdAges: ADULT facility: Northeast Valley Health Corporation city: Van Nuys state: California zip: 91405 country: United States name: Edgar Banuelos role: CONTACT email: edgarbanuelos@nevhc.org name: Herberth Osorio, MPH role: PRINCIPAL_INVESTIGATOR lat: 34.18667 lon: -118.44897 facility: Infectious Disease Practice- Rutgers University city: Newark state: New Jersey zip: 07103 country: United States name: Jared Khan role: CONTACT email: khanjj@njms.rutgers.edu name: Shoba Swaminathan, MD role: PRINCIPAL_INVESTIGATOR lat: 40.73566 lon: -74.17237 facility: Equitas Health city: Cincinnati state: Ohio zip: 45206 country: United States name: Tania Slack-Peterson role: CONTACT email: TaniaSlack@equitashealth.com name: Kelly Wesp, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 facility: Equitas Health city: Columbus state: Ohio zip: 43203 country: United States name: Tania Slack-Peterson role: CONTACT email: TaniaSlack@equitashealth.com name: Kelly Wesp, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 facility: Thomas Street Clinic city: Houston state: Texas zip: 77004-8004 country: United States name: Ernesto Linares Pineda role: CONTACT email: Ernesto.LinaresPineda@bcm.edu name: Shital Patel, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 facility: UW Madison Clinic at Harborview city: Seattle state: Washington zip: 98104 country: United States name: Tala Mahmoud role: CONTACT email: talam2@uw.edu name: H Nina Kim, MD, MPH role: PRINCIPAL_INVESTIGATOR name: Raaka Kumbhakar, MD role: SUB_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False |
<|newrecord|> nctId: NCT06388096 id: PERGCLAD001 briefTitle: CLAD Deconvolved PERG Responses in Glaucoma Patients overallStatus: RECRUITING date: 2023-06-01 date: 2025-06-01 date: 2025-06-01 date: 2024-04-29 date: 2024-04-29 name: Jorvec Corp. class: INDUSTRY name: University of Miami briefSummary: 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 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 120 type: ESTIMATED name: No Intervention Provided measure: PERG Amplitude measure: PERG Latency sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami, Bascom Palmer Eye Institute 900 NW 17th Street status: RECRUITING city: Miami state: Florida zip: 33136 country: United States name: Vittorio Porciatti, MD/PhD role: CONTACT email: vporciatti@med.miami.edu lat: 25.77427 lon: -80.19366 hasResults: False |
<|newrecord|> nctId: NCT06388083 id: LBS-008-CT07 briefTitle: A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt Disease acronym: DRAGON II overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-06 date: 2027-07 date: 2024-04-29 date: 2024-04-29 name: Belite Bio, Inc class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of tinlarebant in subjects with Stargardt Disease conditions: STGD1 conditions: Stargardt Disease 1 studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Tinlarebant name: Placebo measure: To measure the annualized rate of change from baseline lesion size in aggregate area of atrophy measure: To measure the annualized rate of change in total area of atrophy measure: Change in BCVA measured by the ETDRS method sex: ALL minimumAge: 12 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT facility: Belite Study Site city: Dallas state: Texas zip: 75231 country: United States lat: 32.78306 lon: -96.80667 hasResults: False |
<|newrecord|> nctId: NCT06388070 id: HUC3-053 briefTitle: To Evaluate the Efficacy and Safety of HUC3-053 in Patients With Dry Eye Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-04 date: 2024-04-29 date: 2024-04-29 name: Huons Co., Ltd. class: INDUSTRY briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 280 type: ESTIMATED name: HUC3-053 name: Hyalein Mini Drops measure: Change from Baseline in Corneal staining score measure: Change from Baseline in Corneal staining score measure: Change from Baseline in Conjunctival staining score measure: Change from Baseline in Schirmer test measure: Change from Baseline in Tear film break-up time measure: Change from Baseline in Ocular surface disease index measure: Change from Baseline in Soreness after eye drop assessed by NRS sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06388057 id: 5836 briefTitle: Intraoperative Ultrasound in Crohn's Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-06-30 date: 2025-09-01 date: 2024-04-29 date: 2024-04-29 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients with Crohn's disease with an indication for surgery primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: Intraoperative Small Bowel Ultrasonography measure: Specificity and sensibility of intraoperative ultrasound of small bowel in identifying resection margins histologically involved by Crohn's disease sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06388044 id: PRO00115010 briefTitle: ACT for Infertility: Case Series overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-29 date: 2024-04-29 name: Duke University class: OTHER briefSummary: 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 conditions: Psychological Distress conditions: Acceptance and Commitment Therapy conditions: Psychological Flexibility studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Acceptance and Commitment Therapy measure: Acceptability of the Intervention measure: Change in Fertility Problem Inventory (FPI) measure: Change in Patient Health Questionnaire 9 (PHQ-9) measure: Change in Patient Health Questionnaire 2 (PHQ-2) measure: Change in Generalized Anxiety Disorder Questionnaire 7 (GAD-7) measure: Change in Generalized Anxiety Disorder Questionnaire 2 (GAD-2) measure: Change in Modified Differential Emotions Scale (mDES) measure: Change in Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT-15) measure: Change in Intolerance of Uncertainty (IUS) measure: Change in Valuing Questionnaire (VQ) measure: Change in Values-Based Behavior sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duke North Pavilion city: Durham state: North Carolina zip: 27705 country: United States name: Francesca Scheiber, PhD role: CONTACT phone: 919-668-8696 email: fs158@duke.edu name: Julia Woodward, PhD role: SUB_INVESTIGATOR name: Ashley Moskovich, PhD role: SUB_INVESTIGATOR lat: 35.99403 lon: -78.89862 hasResults: False |
<|newrecord|> nctId: NCT06388031 id: CAPTRAL2024v1 briefTitle: ICI Rechallenge for Advanced NSCLC With Long-Term Response to First-Line ICI overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2027-01-10 date: 2027-12-10 date: 2024-04-29 date: 2024-04-29 name: Peking Union Medical College Hospital class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: Immune checkpoint inhibitor measure: Progression Free Survival (PFS) measure: Overall Survival (OS) measure: Objective Response Rate (ORR) measure: Progression Free Survival 2 (PFS 2) measure: Safety profile sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital city: Beijing zip: 100730 country: China lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06388018 id: NRG-GY032 id: NCI-2023-09355 type: REGISTRY domain: CTRP id: CCTG EN.10 type: OTHER domain: CCTG id: U10CA180868 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180868 briefTitle: Tailoring Therapy in Post-surgical Patients With Low-risk Endometrial Cancer overallStatus: SUSPENDED date: 2024-04-16 date: 2025-01-09 date: 2025-01-09 date: 2024-04-29 date: 2024-04-29 name: NRG Oncology class: OTHER name: National Cancer Institute (NCI) name: Canadian Cancer Trials Group briefSummary: 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 conditions: Stage II Uterine Corpus Endometrial Stromal Sarcoma AJCC V8 conditions: Stage III Uterine Corpus Endometrial Stromal Sarcoma AJCC V8 studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 325 type: ESTIMATED name: Clinical Observation name: External Beam Radiation Therapy name: High-Dose-Rate Vaginal Brachytherapy name: Computed Tomography name: Positron Emission Tomography name: X-Ray Imaging name: Magnetic Resonance Imaging name: Questionnaire Administration measure: Time to pelvic recurrence measure: Time to isolated vaginal recurrence measure: Recurrence-free survival measure: Endometrial cancer-specific survival measure: Fear of recurrence sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Washington University School of Medicine city: Saint Louis state: Missouri zip: 63110 country: United States lat: 38.62727 lon: -90.19789 hasResults: False |