Split (1)

train · 22k rows

Record stringlengths 1 197k
The objective of this study is to test whether CIED removal + guideline antibiotic therapy is superior to 6-weeks antibiotic therapy alone in prevention of the composite endpoint of death or relapse bacteremia after 6 months of follow-up in patients with CIED and systemic infection but without definite CIED infection. conditions: Cardiac Implantable Electronic Device Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized open label trial primaryPurpose: TREATMENT masking: NONE maskingDescription: None (Open Label) count: 180 type: ESTIMATED name: Cardiac implantable electronic device extraction name: Empirical antibiotic therapy measure: Rate of death or relapse bacteremia measure: Days alive and out-of-hospital measure: Rate of death measure: Rate of readmission for any cause measure: Rate of cardiac implantable electronic device extraction measure: Rate of relapse bacteremia (the same microorganism) measure: Rate of bacteremia (all species) measure: Rate of definite CIED infection sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06323655 id: VP-VEC-162-1201 briefTitle: Evaluation of Next-Day Residual Effects of Tasimelteon Compared With Placebo and Active Control in Healthy Subjects overallStatus: COMPLETED date: 2018-07-19 date: 2018-08-28 date: 2018-08-28 date: 2024-03-21 date: 2024-03-21 name: Vanda Pharmaceuticals class: INDUSTRY briefSummary: The aim of this study is to investigate next-day residual effects of tasimelteon compared with placebo and active control in healthy subjects. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ACTUAL name: Tasimelteon name: Active Control Placebo name: Tasimelteon Placebo name: Active Control measure: Next-day effects on simulated driving performance as measured by changes in Standard Deviation of Lateral Position (SDLP) sex: ALL minimumAge: 21 Years maximumAge: 55 Years stdAges: ADULT facility: Vanda Investigational Site city: Laval state: Quebec country: Canada lat: 45.56995 lon: -73.692 hasResults: False
<\|newrecord\|> nctId: NCT06323642 id: F.1-1/20ERB/SZABMU/941 briefTitle: Role of Probiotics as Adjunct Therapy Along With Standard Care in Decreasing Hospital Stay and Improving Symptoms in Pediatric Patients Admitted With Severe Pneumonia overallStatus: RECRUITING date: 2023-09-01 date: 2024-03-31 date: 2024-03-31 date: 2024-03-21 date: 2024-03-21 name: Shaheed Zulfiqar Ali Bhutto Medical University class: OTHER briefSummary: Probiotics as adjuvant therapy along with standard care can decrease hospital stay and improve symptoms (fever, tachypnea,cough) in pediatric patients admitted with severe pneumonia. conditions: Pneumonia conditions: Probiotics studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized control trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The patients and their parents/attendants will be kept blind to the fact that they are receiving either probiotic or placebo whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: probiotic containing Lactobacillus rhamnosus GG. name: placebo measure: Number of days in hospital measure: Number of days with cough, fever sex: ALL minimumAge: 6 Months maximumAge: 2 Years stdAges: CHILD facility: Pakistan Institute of Medical Sciences status: RECRUITING city: Islamabad state: Punjab zip: 12000 country: Pakistan name: Nighat Haider, FCPS role: CONTACT phone: 03212125768 email: nighathaider@hotmail.com name: rashiqa saadat, MBBS role: PRINCIPAL_INVESTIGATOR lat: 33.72148 lon: 73.04329 hasResults: False
<\|newrecord\|> nctId: NCT06323629 id: STUDY006201 briefTitle: Effects of Recursive Self-feedback on Speech Production in Aphasia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-03 date: 2024-03-21 date: 2024-03-21 name: University of South Florida class: OTHER name: Center for Smart Use of Technologies to Assess Real-world Outcomes briefSummary: The goal of this clinical trial is to test the effects of recursive self-feedback procedures on spontaneous speech production in stroke survivors with impaired speech production (aphasia). The main question it aims to answer is:
• To what extent can stroke survivors with aphasia use their self-feedback alone to improve their spontaneous speech production?
Participants will be engaged in the following activities:
* They will perform language and cognitive tasks.
* Afterwards, they will receive treatments using tablets and headphones at no cost to them.
* The experimental treatments (recursive self-feedback procedures) entails responding to prompts, listening to playbacks of their speech response and attempt to minimize/correct the errors in the next attempt. This process will be repeated multiple times per prompt.
* The experimental treatments are two: an adaptive version that adapts the complexity of the treatment prompt and a non-adaptive version that does not adapt task complexity.
* Researchers will compare the experimental treatments to see if both have similar effects on improving spontaneous speech production. conditions: Aphasia conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Adaptive recursive self-feedback procedure name: Non-adaptive recursive self-feedback procedure measure: Speaking rate measure: Speech initiation latency in milliseconds sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06323616 id: 2023/2343 briefTitle: The Effect of Anesthesia Depth Monitoring on Emergence Delirium in Pediatrics overallStatus: RECRUITING date: 2024-03-25 date: 2024-08-01 date: 2024-09-01 date: 2024-03-21 date: 2024-03-21 name: Istanbul University class: OTHER briefSummary: Some changes in the patient's cognitive state are observed during the recovery period from general anesthesia. This period of behavioral dysregulation has been called emergence agitation (EA) and emergence delirium (ED). ED and EA occur in the early postoperative period (often within the first 30 minutes). The incidence of ED ranges from 10% to 80% in children and is described as a distressing clinical condition by 42% of pediatric anesthesiologists. Self-harm by the child increases the risk of delayed discharge and may increase the cost of medical care.
Sevoflurane is a widely used agent for the induction and maintenance of anesthesia, but its use is associated with the occurrence of ED in the pediatric population. Clinical findings are characterized by hallucinations, struggling, restlessness, crying, and disorientation.
In the literature, the Pediatric Anesthesia Rescue Delirium (PAED) Scale Score is used in the diagnosis of ED and EA. This score consists of 5 criteria (maximum score 20) scored using 0-4 point scales. These criteria; The child needs to make eye contact with the caregiver, the child's movements are purposeful, the child is aware of the environment, the child is restless/angry, the child cannot be consoled. While the sensitivity of ≥10 points for the diagnosis of ED is 64% and the specificity is 86%, the sensitivity of \>12 points for the diagnosis of ED is 100% and the specificity is 94.5%.
Monitoring intraoperative depth of anesthesia in the adult population has been recommended by the American Society of Anesthesiologists (ASA) due to its potential benefits such as faster recovery time and lower drug dosage, as well as prevention of adverse effects such as the incidence of hypotension. The use of anesthesia depth monitors used so far for children is controversial because brain development in children has not yet been completed and the calculation algorithms of these indices are based on adult EEG characteristics.
There are very few studies in the literature on the relationship between anesthesia depth monitoring and EA/ED in children, and further studies are needed. conditions: Anesthesia conditions: Emergence Delirium conditions: Anesthesia Awareness conditions: Behavior Child Problems conditions: Postoperative Delirium conditions: Postoperative Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, Single-Blind, Prospective, Interventional primaryPurpose: SCREENING masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 270 type: ESTIMATED name: MAC adjustment to PSI between 25 and 50 measure: ED/EA incidence measure: mYPAS measure: PSI <25 episode duration measure: PSI >50 episode duration measure: PSI <25 number of episodes measure: PSI >50 number of episodes measure: Suppresyon ratio measure: SEF95R measure: SEF95L measure: Mean blood pressure measure: Heart rate measure: SpO2 measure: Total amount of sevoflurane used measure: Total amount of remifentanil used measure: MAC measure: Waking up time measure: Pupil size measure: Anesthesia duration measure: Surgery duration measure: PHBQ measure: Ped-PADS measure: Time of discharge from hospital sex: ALL minimumAge: 2 Years maximumAge: 8 Years stdAges: CHILD facility: Istanbul University status: RECRUITING city: Istanbul country: Turkey name: Meltem Savran Karadeniz, Assoc. Prof. role: CONTACT phone: 009005334845563 email: mskaradeniz@gmail.com lat: 41.01384 lon: 28.94966 facility: Istanbul University status: RECRUITING city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06323603 id: 3-1 briefTitle: Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic overallStatus: RECRUITING date: 2023-06-30 date: 2024-06 date: 2024-09 date: 2024-03-21 date: 2024-03-25 name: Ricard Marcos class: OTHER name: Finnish Institute of Occupational Health briefSummary: The biomonitoring study aims to evaluate genotoxic damage and other parameters of exposure in different occupational exposed populations that work directly with different plastics. conditions: Occupational Exposure conditions: Genotoxicity conditions: Damage Dna studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 45 type: ESTIMATED name: Micro and nanoplastic measure: Characterization of macro and nanoplastics measure: Genotoxic evaluation by the Micronucleus assay measure: Genotoxic evaluation by the Comet assay measure: Cytokine release measure: Microbiota analysis from feces by MinIOn measure: Analyses of surrogate biomarkers sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Textile industry status: COMPLETED city: Helsinki country: Finland lat: 60.16952 lon: 24.93545 facility: Recycling company status: COMPLETED city: Alicante country: Spain lat: 38.34517 lon: -0.48149 facility: Textile Industry status: COMPLETED city: Alicante country: Spain lat: 38.34517 lon: -0.48149 facility: Control recruitment status: RECRUITING city: Barcelona country: Spain name: Susana Pastor role: CONTACT lat: 41.38879 lon: 2.15899 hasResults: False
<\|newrecord\|> nctId: NCT06323590 id: UAB 2372 id: UAB type: OTHER domain: UAB briefTitle: Refining the Role of Mid-induction Bone Marrow Biopsy in Acute Myeloid Leukemia: A Pilot Study overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-05 date: 2028-05 date: 2024-03-21 date: 2024-03-21 name: University of Alabama at Birmingham class: OTHER briefSummary: The purpose of the study is to observe the outcomes of patients with acute myeloid leukemia who do not receive an immediate second round of chemotherapy after undergoing a standard mid-induction bone marrow biopsy. conditions: Acute Myeloid Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: rates of complete remission sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Omer Jamy role: CONTACT phone: 205-934-2721 email: omerjamy@uabmc.edu name: Omer Jamy role: CONTACT phone: 2059342721 email: omerjamy@uabmc.edu name: Omer Jamy role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False
<\|newrecord\|> nctId: NCT06323577 id: TUH rKA vs MA TKA briefTitle: Comparing Efficacy Between Restricted Kinematic Alignment vs Mechanical Alignment in Bilateral TKA overallStatus: RECRUITING date: 2024-03-14 date: 2026-05-31 date: 2026-05-31 date: 2024-03-21 date: 2024-03-21 name: Thammasat University Hospital class: OTHER briefSummary: The goal of this RCT is to investigate efficacy between restricted kinematic alignment and mechanical alignment TKA in simultaneous bilateral TKA patients.
The main question\[s\] it aims to answer are:
* Does rKA have better functional outcomes than MA in simultaneous bilateral TKA patients?
* Does rKA have lower pain score than MA in simultaneous bilateral TKA patients? Participants will undergo simultaneous bilateral TKA and randomized one side will use rKA and the other side will use MA. conditions: Osteoarthritis, Knee conditions: TKA studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Restricted kinematic alignment name: Mechanical alignment measure: Forgotten joint score measure: Modified WOMAC score measure: Range of motion measure: Pain score measure: Hip knee ankle angle measure: Complications measure: Incidence of soft tissue releasing sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thammasat University status: RECRUITING city: Khlong Luang state: Pathum Thani zip: 12120 country: Thailand name: Yot Tanariyakul, M.D. role: CONTACT phone: 663930257 email: y.tanariyakul@gmail.com name: Nattapol Tammachote, M.D. role: PRINCIPAL_INVESTIGATOR lat: 14.06467 lon: 100.64578 hasResults: False
<\|newrecord\|> nctId: NCT06323564 id: 21C223 briefTitle: Exploring Emotional Intelligence and Cognitive Flexibility in Anorexia Nervosa and Parkinson's Disease. acronym: INTELLEGO overallStatus: RECRUITING date: 2023-01-13 date: 2024-08-13 date: 2025-01-13 date: 2024-03-21 date: 2024-03-21 name: Istituto Auxologico Italiano class: OTHER briefSummary: The main aim of this study is to demonstrate how disorders characterized by different types of "inflexibility", cognitive-affective type for Anorexia nervosa and motor one for Parkinson's disease, have an impact on how emotional stimuli are processed and on the transition within emotional states. conditions: Anorexia Nervosa conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Neuropsychological tests in PD name: Self-report questionnaires in PD name: International Affective Picture System (IAPS) name: Neuropsychological tests in AN name: Self-report questionnaires in AN name: Analysis of bio-humoral parameters measure: Change in International Affective Picture System (IAPS) measure: Change in self-report questionnaires - STAI measure: Change in self-report questionnaires - BDI measure: Change in Heart rate variability measure: Change in analysis of bio-humoral parameters sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano status: RECRUITING city: Oggebbio zip: 28824 country: Italy name: Riccardo Cremascoli, MD, PhD role: CONTACT lat: 45.99088 lon: 8.64663 hasResults: False
<\|newrecord\|> nctId: NCT06323551 id: 2023/50 briefTitle: The Effect of Mother's Smell and Breast Milk Smell on Pain overallStatus: RECRUITING date: 2024-03-14 date: 2024-07-14 date: 2024-12-24 date: 2024-03-21 date: 2024-03-25 name: Tarsus University class: OTHER briefSummary: The research was planned as a randomized controlled study to investigate the effect of breast milk smell and mother's smell applied while heel blood was taken to term babies in the Mersin City EAH Neonatal Intensive Care Unit between October and December 2023, on acute pain and crying duration. During the heel prick procedure, which is routinely performed in the neonatal intensive care unit, no pharmacological/non-pharmacological method will be applied to the control group to reduce the baby's pain before, during and after the heel prick. The baby's pain score will be evaluated by the observing nurse according to the NIPS pain scale 5 minutes before, during and 5 minutes after the procedure.
In the study group that will be made to smell the mother's scent; The mother of each baby whose heel blood will be taken will be given a specially made cover made of 100% cotton yarn, sterilized the day before, and the mother will be asked to put the cover on her bare skin (on her bare skin) after the shower and to keep the cover on the mother's chest for one night (8 hours). It will be placed 15 cm away from the baby and smelled 5 minutes before and 5 minutes after the heel prick attempt. The baby's pain score will be evaluated by the observing nurse according to the NIPS pain scale 5 minutes before, during and 5 minutes after the procedure. conditions: Newborn; Vitality conditions: Pain conditions: Crying studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled primaryPurpose: OTHER masking: NONE count: 90 type: ESTIMATED name: Mother's Smell name: Mother's Breast Milk Smell measure: Neonatal Infant Pain Scale measure: criying time sex: ALL minimumAge: 1 Day maximumAge: 15 Days stdAges: CHILD facility: Tarsus State Hospital status: RECRUITING city: Mersin country: Turkey name: Atiye Karakul, Ass. Prof. role: CONTACT phone: 90(324) 600 00 33 phoneExt: 2231 email: atiyekarakul@gmail.com lat: 36.79526 lon: 34.61792 hasResults: False
<\|newrecord\|> nctId: NCT06323538 id: 01 briefTitle: Cohort Study on Plant-based Diets (COPLANT Study) acronym: COPLANT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-03-31 date: 2047-03-31 date: 2024-03-21 date: 2024-03-22 name: German Federal Institute for Risk Assessment class: OTHER name: Max Rubner-Institut name: University of Bonn name: Research Institute for Plant-Based Nutrition name: University of Jena name: University of Regensburg name: Heidelberg University name: University of Vienna briefSummary: The Cohort on Plant-based Diets (COPLANT) study is a multi-centre cohort study that starts baseline recruitment from 2024 to 2027 with approximately 6,000 participants in Germany and Austria. The COPLANT study focuses on vegan (no animal products), vegetarian (no meat and fish, but dairy products and eggs), pescetarian (no meat, but fish) and omnivorous (mixed diet including all possible animal products) diets. The aim of the COPLANT study is to gain new insights on health benefits and risks as well as social, ecological and economic effects of different plant-based diets in comparison to a mixed diet. In addition to a detailed dietary survey using an app adapted to the needs of this study, the baseline examination includes measurements of body composition, bone health, cardiovascular risk factors, diabetes risk, contaminants and lifestyle. For the basic laboratory program, fasting blood, 24-hour urine collection and a stool sample are taken from all study participants. Furthermore, specific aspects of dietary behavior, physical activity and other lifestyle factors are collected via questionnaires. Follow-up studies are planned at intervals of 5, 10 and 20 years after the baseline visit. conditions: Dietary Exposure conditions: Diabetes Mellitus, Type 2 conditions: Cardiovascular Diseases conditions: Bone Loss conditions: Sustainability conditions: Exposure conditions: Obesity conditions: Vitamin Deficiency conditions: Mineral Deficiency studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 6000 type: ESTIMATED measure: Incidence of diabetes type 2 measure: Incidence of cardiovascular diseases measure: Incidence of cancer measure: Vitamin B12 measure: Holo-transcobalamine measure: Homocysteine measure: Methylmalonic acid measure: Vitamin B1 status measure: Vitamin B2 status measure: Vitamin B6 status measure: Vitamin C status measure: Vitamin D status measure: Vitamin E status measure: Iron measure: Ferritin measure: Transferrin measure: Zinc status measure: Selenium status measure: Iodine status measure: Blood pressure measure: Blood lipids measure: Fasting insulin measure: Fasting glucose measure: Glycated hemoglobin (HbA1c) measure: C-peptide measure: Osteocalcin measure: Ostase measure: Parathormone measure: N-terminal propeptide of type I procollagen (PINP) measure: C-terminal telopeptide of type I collagen (CTX) measure: Creatinine measure: Uric acid measure: Cytstatin C measure: Thyroid stimulating hormone (TSH) measure: Free triiodothyronine (fT3) measure: Free thyroxine (fT4) measure: Body fat measure: Skeletal muscle mass measure: Total Body Water measure: Energy intake measure: Nutrient intake measure: Intake of dietary supplements measure: Intake of medication measure: Heavy metals measure: Halogenated, polycyclic aromatic hydrocarbons (dioxins) measure: Mycotoxins measure: Per- and polyfluoroalkyl substances (PFAS) measure: Microbiome sex: ALL minimumAge: 18 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Vienna city: Vienna zip: 1090 country: Austria lat: 48.20849 lon: 16.37208 facility: Max Rubner-Institut city: Karlsruhe state: Baden-Württemberg zip: 76131 country: Germany name: Benedikt Merz, PhD role: CONTACT email: benedikt.merz@mri.bund.de lat: 49.00937 lon: 8.40444 facility: Friedrich-Schiller University city: Jena state: Thuringia zip: 07743 country: Germany name: Christine Dawczynski, PhD role: CONTACT phone: +49 3641 949656 email: christine.dawczynski@uni-jena.de lat: 50.92878 lon: 11.5899 facility: The German Federal Institut for Risk Assessment city: Berlin zip: 10589 country: Germany name: Cornelia Weikert, Prof role: CONTACT phone: +49 30 1841255000 email: Cornelia.Weikert@bfr.bund.de lat: 52.52437 lon: 13.41053 facility: University Bonn city: Bonn country: Germany name: Ute Nöthlings, Prof role: CONTACT email: noethlings@uni-bonn.de lat: 50.73438 lon: 7.09549 facility: Research Institute for Plant-Based Nutrition, Gießen city: Gießen zip: 35444 country: Germany name: Markus Keller, PhD role: CONTACT email: keller@ifpe-giessen.de lat: 50.58727 lon: 8.67554 facility: University Heidelberg city: Heidelberg zip: 69120 country: Germany name: Ina Danquah role: CONTACT email: ina.danquah@uni-heidelberg.de lat: 49.40768 lon: 8.69079 facility: University Regensburg city: Regensburg zip: 93053 country: Germany name: Michael Leitzmann, Prof role: CONTACT email: Michael.Leitzmann@klinik.uni-regensburg.de name: Beate Fischer role: CONTACT email: Beate.Fischer@klinik.uni-regensburg.de lat: 49.01513 lon: 12.10161 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-11-20 uploadDate: 2024-02-23T09:43 filename: Prot_000.pdf size: 1528917 hasResults: False
<\|newrecord\|> nctId: NCT06323525 id: CHN-PLAGH-BT-083 briefTitle: TCR Reserved and Power3 Gene Knock-out Allogeneic CD19-targeting CAR-T Cell Therapy in r/r B Cell Lymphoma overallStatus: RECRUITING date: 2024-04-17 date: 2026-04-25 date: 2027-04-25 date: 2024-03-21 date: 2024-04-18 name: Chinese PLA General Hospital class: OTHER briefSummary: The safety and efficacy of the chimeric antigen receptor (CAR)-T, a CD19-targeting, TRAC and Power3 double genes deleted allogeneic CAR-T cell product, are undergoing rigorous evaluation in non-Hodgkin's lymphoma (NHL) subjects from our ATHENA trial (NCT06014073). Unexpectedly, expansion of the initial residual CD3-positive CAR T from products were measured in patients' peripheral blood (PB) without exception. Accompanying with host immune reconstitution and appearance of the detectable B cells, the CD3-positive allogenic CAR T cells exhibited a compelling amplification advantage over CD3-negative CAR T cells. The amplification of CD3-positive CAR T cell population dynamically suppressed host B cell recovery, and presumably surveilled the recurrence or progression of tumors, but did not induce typical Graft-versus-host-disease (GvHD). Additionally, a series of in vitro experiments illustrated that the HLA-mismatched fratricide between host T cells and TCR-reserved Power3-deleted allogenic CAR T cells was markedly slashed, which in combination with our observed clinical safety date supported the notion that only genomic deletion of Power3 gene in allo-CAR T cells is sufficient to overcome GvHD and host T cell-mediated rejection response.
In the ATHENA-2 study, our design is to preserve the expression of the TCR on T cells from healthy donors while selectively disabling the Power3 gene to prepare ATHENA-2 CAR T cells. This approach harnesses the tonic signaling of CAR T cells, resulting in enhanced persistence and improved response to treatment. The purpose of this study is to evaluate the safety and efficacy of ATHENA-2 in B-cell NHL. conditions: Non-hodgkin Lymphoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: TCR reserved and Power3 gene knock-out allogeneic CD19-targeting CAR-T cell (ATHENA-2 CAR-T) name: Fludarabine name: Cyclophosphamide measure: Phase 1: Incidence of adverse events (AEs) defined as DLT measure: Phase 1: Recommended phase 2 dose (RP2D) measure: Phase 2: 3-month objective response rate (ORR) measure: Phase 2: Complete response (CR) rate measure: Phase 2: Duration of Response (DOR) measure: Phase 2: Overall Survival (OS) measure: Phase 2: Progression Free Survival (PFS) measure: Phase 1 and phase 2: Pharmacokinetics: Level of ATHENA-2 CAR-positive T cells circulating in blood over time measure: Phase 1 and phase 2: Pharmacodynamics: Level of CD19+ cells in peripheral blood measure: Phase 1 and phase 2: Level of serum cytokines in peripheral blood measure: Phase 1: 3-month ORR measure: Phase 1: OS measure: Phase 1: PFS measure: Phase 2: Incidence of AEs measure: Phase 1: Level of donor-specific antibody (DSA) in blood. measure: Phase 1: Level of human anti-mouse antibodies (HAMA) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Biotherapeutic Department of Chinese PLA General Hospital status: RECRUITING city: Beijing state: Beijing zip: 100853 country: China name: Weidong Han, M.D role: CONTACT phone: +86-010-66937463 email: hanwdrsw@sina.com name: Qingming Yang, M.D role: SUB_INVESTIGATOR name: Yang Liu, M.D role: SUB_INVESTIGATOR name: Jinhong Shi, M.S role: SUB_INVESTIGATOR name: Chunmeng Wang, M.S role: SUB_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Biotherapeutic Department of Chinese PLA General Hospital status: RECRUITING city: Beijing country: China name: Weidong Han, Ph.D role: CONTACT phone: +86-010-55499341 email: hanwdrsw@sina.com lat: 39.9075 lon: 116.39723 facility: EdiGene Inc status: RECRUITING city: Beijing country: China name: Zixuan Pang, Ph.D role: CONTACT phone: 010-80733899 email: zxpang@edigene.com lat: 39.9075 lon: 116.39723 facility: School of Life Sciences, Peking University status: RECRUITING city: Beijing country: China name: Wensheng Wei, Ph.D role: CONTACT phone: 010-62757794 email: wswei@pku.edu.cn lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06323512 id: Nanjing briefTitle: Pulmonary Arteyr Denervation for Heart Failure overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-11-01 date: 2025-12-30 date: 2024-03-21 date: 2024-04-24 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: Prolonged pulmonary venous congestion culminates in pulmonary hypertension, defined as a mean pulmonary arterial pressure \> 20 mmHg and pulmonary artery wedge pressure \>15 mmHg at rest, as determined by right heart catheterization. Pulmonary hypertension secondary to heart failure (PH-HF) is further stratified into isolated post-capillary pulmonary hypertension (Ipc-PH, pulmonary vascular resistance (PVR) is ≤2 Woods Unit) and combined pre- and post-capillary pulmonary hypertension (Cpc-PH, PVR \> 2 Woods Unit), the later reflecting additional pulmonary vascular constriction or remodeling in addition to passive PH. While medications tailored for World Health Organization defined Group I pulmonary arterial hypertension are not endorsed for PH-HF according to current guidelines, the coexistence of pulmonary hypertension exacerbates the severity of heart failure. Given the presence of pulmonary arterial vasoconstrictor and heightened sympathetic nervous activity in patients with heart failure, the PADN-5 study has demonstrated the safety and efficacy of pulmonary artery denervation (PADN) for patients with CpcPH, characterized by the improvements in left ventricular ejection fraction, cardiac output, clinical outcome, and reductions in left atrial pressure, pulmonary arterial pressure, and PVR. Our objective is to assess the feasibility, safety, and efficacy of PADN for patients with heart failure independent of left ventricular ejection fraction (HFrEF or HFpEF) without pulmonary hypertension (N=30, 15 with HFrEF and another 15 with HFpEF). conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Pulmonary artery denervation (PADN) measure: Left ventricular ejection fraction measure: Tricuspid annuls peak systolic excursion (TAPSE) measure: 6 minute walk distance changes measure: All-cause death measure: Rehospitalization measure: NT-proBNP measure: Superoxide dismutase (SOD) 3 measure: Plasma noradrenaline measure: All outcomes will be stratified by HFrEF and HFpEF sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06323499 id: UK Essen briefTitle: Outcome of Induced Atypical Atrial Flutter overallStatus: COMPLETED date: 2018-04-01 date: 2021-10-31 date: 2021-10-31 date: 2024-03-21 date: 2024-04-24 name: University Hospital, Essen class: OTHER briefSummary: Background: Atypical atrial flutter (AAF) is an increasingly relevant clinical problem. Despite advancements in mapping and ablation techniques, the general management of these patients remain challenging especially when mapping cannot be performed during ongoing arrhythmia. There are no data whether induction of AAF is a feasible approach in these cases.
Methods: The investigators retrospectively analyzed patients who underwent catheter ablation of AAF and compared procedural results between patients with ongoing tachycardia when starting the procedure and patients with induced AAF.
For this retrospective study, the investigators analyzed patients undergoing ablation of AAF between April 2018 and January 2021 that were identified from the ablation database at the West German Heart and Vascular Center, Essen. All patients were followed up in the outpatient clinic as part of the clinical standard routine or contacted by telephone to assess the occurrence of clinical recurrence of any arrhythmia. In case the documentation was not performed at the institution, relevant documents and ECGs were requested and reviewed.
This single-center cohort study was conducted at the University Hospital Essen, Germany, in accordance with the Declaration of Helsinki and its amendments and was approved by the institutional review board of the University of Essen (number 21-10341-BO). Written informed consent was obtained from all study participants.
The primary study endpoint was to evaluate the outcome of patients with induced AAF in comparison to patients with ongoing AAF when starting the procedure. Furthermore, the investigators analyzed the type of recurrence during follow-up as well as the occurrence and results of repeat ablations at the institution. The investigators also evaluated if the recurrent AAF form was the same or de-novo compared to the AAF during previous procedure. conditions: Tachyarrhythmia conditions: Atypical Atrial Flutter conditions: Induction of Arryhthmia conditions: Clinical Outcome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 76 type: ACTUAL name: Induction of atypical atrial flutter measure: Outcome of patients with induced AAF in comparison to patients with ongoing AAF when starting the procedure. measure: Type of recurrence during follow-up measure: Occurrence and results of repeat ablations at our institution sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Essen city: Essen state: Nordrhein-Westfalen zip: 45147 country: Germany lat: 51.45657 lon: 7.01228 hasResults: False
<\|newrecord\|> nctId: NCT06323486 id: 23-015-B briefTitle: Accelerated Bilateral Sequential Theta Burst Stimulation in Older Adults With Treatment-resistant Depression acronym: CogniTReaD overallStatus: RECRUITING date: 2024-04-01 date: 2026-03-30 date: 2026-03-30 date: 2024-03-21 date: 2024-03-21 name: Ontario Shores Centre for Mental Health Sciences class: OTHER name: Sunnybrook Health Sciences Centre briefSummary: The CogniTReaD study is a pilot clinical trial that will compare the effects of active accelerated bilateral sequential theta burst stimulation (absTBS) and sham or inactive treatment. The goal is to see if absTBS can help older adults with treatment-resistant depression (TRD) by looking at dual-task cost and mood, as well as other cognitive functions, anxiety levels, quality of life, and physical performance, while also checking for any treatment side effects. The study will recruit participants who will receive different study treatments in a specific order. The study will be double-blinded, meaning neither the participants nor the researchers will know who is receiving which treatment. The study will include people who are 50 years old or older and diagnosed with treatment-resistant depression with at least a moderate severity of depression. This study seeks to discover if absTBS can modify a dementia risk marker (i.e., dual-task cost and depression) in older patients with TRD, and to determine the effect size for larger investigations in the future. conditions: Depressive Disorder, Treatment-Resistant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: We will enroll patients who are willing to be randomized to either the accelerated bilateral sequential theta burst stimulation (absTBS)-sham or sham-absTBS treatment sequence arms. In the absTBS-sham sequence, participants shall receive the active absTBS treatment at Week 1, followed by sham treatment at Week 3, while in the sham-absTBS sequence, participants shall receive sham treatment at Week 1, followed by the active absTBS treatment at Week 3. The primary rationale for employing this sequential treatment strategy for both arms in this trial is to ensure that those assigned to the sham-absTBS group do not have to wait for longer periods to begin receiving the active absTBS therapy and to maintain blinding continuity. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: We shall perform a double-blinding system where the participants, study investigators, transcranial magnetic stimulation (TMS) technicians (those who operate and administer TMS procedures), and research assistants (outcome assessors) are masked to the assignment of the enrolled participants. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: active accelerated bilateral sequential theta burst stimulation and sham treatment measure: Change in Dual-task Cost measure: Change in Hamilton Depression Rating Scale 17 (HAMD-17) score measure: Adverse events (AE) measure: Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) score measure: Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) plus modalities score measure: Change in Trail Making A (TMT-A) score measure: Change in Trail Making B (TMT-B) score measure: Change in Digit Symbol Substitution Test (DSST) score measure: Change in Digit Span Forward (DSF) score measure: Change in Digit Span Backward (DSB) score measure: Change in Category Verbal Fluency (CVF) score measure: Change in Montreal Cognitive Assessment (MoCA) score measure: Change in Colour Word Interference Test (CWIT) score measure: Change in Patient Health Questionnaire-9 (PHQ-9) score measure: Change in Geriatric Depression Scale 30 (GDS-30) score measure: Change in Generalized Anxiety Disorder 7 (GAD-7) score measure: Change in Short Form 36 (SF-36) score measure: Change in Alzheimer Disease Cooperative Study - Activities of Daily Living inventory (ADCS-ADL) score measure: Change in Lawton-Brody Instrumental Activities of Daily Living (LB-IADL) score measure: Change in Clinical Global Impression (CGI) score measure: Change in Short Physical Performance Battery (SPPB) score measure: Change in Timed Up & Go (TUG) score sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ontario Shores Centre for Mental Health Sciences status: RECRUITING city: Toronto state: Ontario zip: L1N 5S9 country: Canada name: Amer M. Burhan, MBChB, MSc role: CONTACT phone: 905.430.4055 phoneExt: 4019 email: burhana@ontarioshores.ca name: Adrian I. Espiritu, MD role: CONTACT phone: 905.430.4055 phoneExt: 6271 email: espiritua@ontarioshores.ca lat: 43.70011 lon: -79.4163 hasResults: False
<\|newrecord\|> nctId: NCT06323473 id: Maitake001 briefTitle: Maitake for Integrative Cancer Care acronym: Maitake overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-08-01 date: 2025-09-01 date: 2024-03-21 date: 2024-03-21 name: The Canadian College of Naturopathic Medicine class: OTHER briefSummary: Maitake is an edible mushroom that is used for both its nutritional and medicinal properties. Human and animal studies have shown Maitake may help improve immune function; however, its effectiveness in people with cancer is not clear. The investigators aim to measure if Maitake has any immunomodulatory effects when given alongside conventional systemic cancer therapy. conditions: Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Uncontrolled single arm clinical trial primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Black Maitake Prothera measure: Changes in absolute neutrophil count measure: Incidence of febrile neutropenia measure: Change in neutrophil to lymphocyte ratio (NLR) measure: Change in platelet to lymphocyte ratio (PLR) measure: Change in high-sensitivity C-reactive protein (CRP) measure: Changes in Quality of Life measure: Changes in hemoglobin A1c (HbA1c) measure: Incidence of adverse events measure: Incidence of dose reductions or delays in systemic therapy measure: Addition of new medications to combat neutropenia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Centre for Health Innovation city: Ottawa state: Ontario zip: K2P 0M7 country: Canada name: Mark Legacy role: CONTACT phone: 613-792-1222 phoneExt: 1 email: mlegacy@thechi.ca lat: 45.41117 lon: -75.69812 facility: Canadian College of Naturopathic Medicine - Integrative Cancer Centre city: Toronto state: Ontario zip: M2K 1E2 country: Canada name: Daniel Lander role: CONTACT phone: 416-498-1255 phoneExt: 280 email: dlander@ccnm.edu lat: 43.70011 lon: -79.4163 hasResults: False
<\|newrecord\|> nctId: NCT06323460 id: OSU-23083 id: NCI-2024-00904 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) briefTitle: Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer overallStatus: RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-21 date: 2024-03-21 name: Ohio State University Comprehensive Cancer Center class: OTHER briefSummary: This phase II trial studies how well using circulating tumor deoxyribonucleic acid (DNA) to guide lower dose radiation therapy works in treating patients with human papillomavirus infection (HPV)-associated oropharyngeal cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Recently, a blood test has been developed to detect the human papillomavirus in the blood and determine how many viral particles are present. Researchers want to compare any good and bad effects of using the lower dose radiation therapy with chemotherapy compared to the usual standard of care dose chemotherapy in patients who clear the human papillomavirus particles from their blood. conditions: Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 conditions: Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 conditions: Oropharyngeal Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Biospecimen Collection name: Carboplatin name: Cisplatin name: Computed Tomography name: External Beam Radiation Therapy name: Paclitaxel name: Positron Emission Tomography name: Questionnaire Administration measure: Positron emission tomography complete response measure: Progression free survival measure: Incidence of adverse events measure: Quality of life (QOL) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio State University Comprehensive Cancer Center status: RECRUITING city: Columbus state: Ohio zip: 43210 country: United States name: Sujith Baliga role: CONTACT phone: 614-293-5066 email: Sujith.baliga@osumc.edu name: Sujith Baliga role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False
<\|newrecord\|> nctId: NCT06323447 id: PC002 briefTitle: Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia acronym: PC002 overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2025-04-30 date: 2025-05-28 date: 2024-03-21 date: 2024-03-21 name: Leuko Labs, Inc. class: INDUSTRY briefSummary: Pivotal study to validate the diagnostic performance of PointCheck, the first non invasive device to preliminary detect neutropenia in cancer patients receiving intermediate/high risk antineoplastic therapy. conditions: Diffuse Large B Cell Lymphoma conditions: Multiple Myeloma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 210 type: ESTIMATED name: PointCheck measure: PointCheck Accuracy measure: PointCheck Precision measure: PointCheck Usability measure: PointCheck Errors measure: PointCheck Safety sex: ALL minimumAge: 10 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06323434 id: spice1 briefTitle: Spinal CSF Leaks in Chronic Subdural Hematoma acronym: SPICE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-10 date: 2024-03-21 date: 2024-04-22 name: University of Freiburg class: OTHER briefSummary: Background: Chronic subdural hematoma (cSDH) is a type of intracranial bleeding, predominantly affecting the elderly and males, with an estimated incidence of 8/100.000. The collection of subdural fluid expands slowly, leading eventually to brain tissue compression that results in neurological impairment such as seizures, cognitive decline, and paresis. Most patients need neurosurgical evacuation of the blood to improve and to prevent further, possibly permanent deterioration. Evidently, the cause of such a bleeding must be investigated and if possible treated, or preventive strategies need to be installed if possible. Spinal cerebrospinal fluid (CSF) leaks are a known cause of cSDH but are widely underdiagnosed in this population.
The spinal CSF leak causes CSF loss that leads to intracranial hypotension, expansion of intracerebral veins, and traction to the brain and the surrounding tissues. A cSDH is a severe complication of such a leak and occurs in about 30% of all cases with a predominance among the elderly. It is crucial to identify these patients with a spinal leak as treatment pathways differ essentially from patients without a leak. Some smaller studies indicated a prevalence of spinal CSF leaks among cSDH patients of 30% to 80% depending on selection criteria (age, extend of cSDH). Notably, the entity of the CSF-venous fistula, that has been discovered as recent as 9 years ago, and that by now is accounting for 20-25% of all spinal leaks, has not been considered in previous research on cSDH and spinal CSF leaks.
Currently, there is no prospective data on spinal CSF leaks in patients with cSDH. Establishment of such data is crucial to improve diagnostic and therapeutic algorithms for spinal CSF leaks in patients with cSDH.
Objective: To prospectively assess the prevalence of spinal CSF leaks in patients with cSDH Methods: This is a prospective observational, monocentric study on patients admitted due to cSDH to the Department of Neurosurgery at the Medical Center of the University of Freiburg. Treatment and diagnostic procedures will follow standard protocols. The number of spinal CSF leaks will be assessed to generate the prevalence of spinal CSF leaks in this patient cohort. Furthermore, clinical data, the specific type of the CSF leak, and imaging parameters are assessed systematically to estimate the diagnostic value of these measures. conditions: Chronic Subdural Hematoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 220 type: ESTIMATED measure: evidence of a spinal CSF leak (yes/no) measure: Number of identified CSF leak types: measure: Number of diagnostic procedures performed: measure: Number, and site of interventions needed for cSDH: measure: Color of hematoma evacuated: measure: Age measure: body height measure: body weight measure: Body mass index (BMI) measure: sex measure: Karnofsky Index measure: Anti-platelet therapy intake measure: Anticoagulation intake measure: Blood pressure medication intake measure: Lipid regulation medication intake measure: Hormonal regulation medication intake measure: Immunotherapeutic medication intake measure: other medication intake measure: history of trauma measure: national institutes of health stroke scale (NIHSS) measure: gait disorder measure: Modified Rankin Scale (mRS) measure: Headache-Impact-Test (HIT)-6 measure: current working capacity, measure: complaints measure: headache severity measure: Days within the last month measure: maximum duration being continuously upright measure: severeness of dizziness measure: Severeness of shoulder- and neck pain measure: severeness of nausea measure: severeness of hearing disturbances and tinnitus measure: severeness of cognitive deficits measure: severeness of visual disturbances measure: exhaustion measure: ability to focus and concentrate measure: Patient's Global Impression of Change (PGIC) measure: Self-Administered Comorbidity Questionnaire (SCQ) measure: 5 dimension / 5 levels European Quality of life questionnaire (EQ-5D-5L) Index measure: 5 dimension / 5 levels European Quality of life questionnaire (EQ-5D-5L) visual analogue scale measure: Hematocrit measure: Size of the chronic subdural hematoma measure: Volumetry of the cranial compartments measure: Bern-Score according to Dobrocky et al measure: Spinal longitudinal extradural fluid collection (SLEC) measure: DiverTICula (TIC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Freiburg city: Freiburg state: Baden-Württemberg zip: 79106 country: Germany name: Katharina Wolf, Dr. role: CONTACT phone: +4076127093556 email: katharina.wolf@uniklinik-freiburg.de name: Jürgen Beck, Prof. role: PRINCIPAL_INVESTIGATOR name: Amir El Rahal, Dr. role: SUB_INVESTIGATOR name: Niklas Lützen, Dr. role: SUB_INVESTIGATOR name: Horst Urbach, Prof. role: SUB_INVESTIGATOR name: Mukesch J Shah, Dr. role: SUB_INVESTIGATOR name: Christian Taschner, Prof. role: SUB_INVESTIGATOR name: Marco Reisert, Dr. role: SUB_INVESTIGATOR name: Manou Overstijns role: SUB_INVESTIGATOR name: Katharina Wolf, Dr. role: SUB_INVESTIGATOR name: Florian Volz, Dr. role: SUB_INVESTIGATOR lat: 47.9959 lon: 7.85222 hasResults: False
<\|newrecord\|> nctId: NCT06323421 id: STUDY2023-1359 briefTitle: Targeting Chronic Stress for Reducing Risk Factors for Colorectal Cancer acronym: MindCRC overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2025-04-15 date: 2025-08-31 date: 2024-03-21 date: 2024-03-21 name: University of Illinois at Chicago class: OTHER briefSummary: Many neighborhoods in Chicago experience daily exposure to stressors including economic inopportunity and violent crime in public spaces. There is mounting evidence that chronic psychosocial stress can facilitate carcinogenesis by modulating the gut microbiome and immune system. The proposed research aims to study the practice of mindfulness to mitigate CPS and reduce colorectal cancer risk factors among Black American women at elevated risk. conditions: Mindfulness conditions: Colon Cancer conditions: Females studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: Mindfulness measure: Feasibility measures measure: Acceptability measure: Body mass index measure: Stress measure measure: Fasting glucose measure: Gut microbiota composition measure: Gut inflammation measure: Adiposity measure: Epinephrine measure: Norepinephrine measure: Cortisol measure: Resting heart rate measure: Blood lipids measure: Fasting insulin measure: Hemoglobin A1c measure: Systemic inflammation sex: FEMALE minimumAge: 45 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Illinois at Chicago city: Chicago state: Illinois zip: 60612 country: United States name: Lisa Tussing-Humphreys, PhD role: CONTACT phone: 312-355-5521 email: tussing@uic.edu lat: 41.85003 lon: -87.65005 hasResults: False
<\|newrecord\|> nctId: NCT06323408 id: BZKF-AYA_1.0 briefTitle: Integrated Analysis of Therapy Response and Resistence in Embryonal Tumors and Gliomas acronym: BZKF-AYA overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-09 date: 2026-03 date: 2024-03-21 date: 2024-03-21 name: University Hospital Regensburg class: OTHER briefSummary: The treatment of adolescents and young adults (AYA, 15 to 39 years) with malignant intra-axial CNS parenchymal tumors such as IDH-mutated gliomas, medulloblastomas and ependymomas is still not curative in all cases. The tumor biology and clinical needs to diagnose and treat these tumors are comparable across all age groups, so an integrated treatment environment overseen by adult and pediatric neuro-oncology specialists seems promising to leverage synergisms and advance diagnostic and therapeutic development in these tumors. A comprehensive, prospective and integrated biomaterial and imaging-based pipeline for the multi-faceted evaluation of AYAs has not yet been established for AYA patients with brain tumors in Germany. Current diagnostic platforms neglect the integrative processing of data from MRI and FET-PET imaging, radiotherapy plans, tumor tissue, liquid biopsies and clinical data as well as prognostic markers. A prospective AYA pipeline can therefore enable a better understanding of the aforementioned high-risk CNS malignancies and promises clinical advances for AYA patients and the clinical and scientific research landscape. conditions: Glioma, Malignant conditions: Embryonal Tumor conditions: Medulloblastoma conditions: Ependymoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 72 type: ESTIMATED name: Tissue, blood, cerebrospinal-spinal fluid measure: AI processing of MRI fand PET or diagnosis measure: AI processing of MRI and PET for evaluation of response and relapse measure: Quality control analysis in radiotherapy measure: Analysis of response in liquid biopsies measure: Target molecules in tissue and liquid biopsies measure: Evaluation of progression free survival sex: ALL minimumAge: 15 Years maximumAge: 39 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06323395 id: JGL-DED-VIZ-SLB 21 briefTitle: Vizol S Lipid Balance Efficacy and Safety Study in Patients With Dry Eye overallStatus: COMPLETED date: 2022-06-01 date: 2022-12-01 date: 2022-12-01 date: 2024-03-21 date: 2024-03-21 name: Jadran Galenski laboratorij d.d. class: INDUSTRY name: Poseidon CRO briefSummary: The clinical investigation was intended to investigate the efficacy, ocular tolerability and safety of Vizol S Lipid Balance, a new eye drops, emulsion developed by JADRAN - GALENSKI LABORATORIJ d.d., in patients with moderate to severe evaporative DED after a treatment for 30 days. conditions: Dry Eye Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multi-centre, randomised, parallel-group, controlled (placebo), double-blind study primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: As the clinical trial will be conducted in a double-blind way, both investigators and patients will be blind with respect to the treatment administered. For the purpose of individual unblinding of a patient's treatment the investigator will receive a sealed emergency envelope for each patient containing the treatment code (Only in case of medical emergency it is permitted to open the emergency envelope). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 64 type: ACTUAL name: Vizol S LIPID BALANCE eye drops name: ophthalmic saline eye drops measure: Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 3 (day 30) measure: Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 15) measure: percent (%) change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 15) and from Visit 1 (baseline) to Visit 3 (day 30) measure: Mean change in ocular surface staining score (total corneal and total conjunctival staining score) from Visit 1 (baseline) to Visit 3 (day 30) measure: Mean change in OSDI score from Visit 1 (baseline) to Visit 3 (day 30) measure: Mean change in Meibomian gland expression from Visit 1 (baseline) to Visit 3 (day 30) measure: The presence of Adverse Event/ /Serious Adverse Event (AE/ /SAE) throughout the investigation period measure: BCVA measure: Frequency of ocular signs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Special eye hospital - Beogradski oftalmološki centar city: Belgrad zip: 11000 country: Serbia lat: 44.80401 lon: 20.46513 facility: Specialized clinic for eye desease - klinika Veselinović city: Niš zip: 18000 country: Serbia lat: 43.32472 lon: 21.90333 hasResults: False
<\|newrecord\|> nctId: NCT06323382 id: Liver Project 6 briefTitle: Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma overallStatus: RECRUITING date: 2021-01-01 date: 2024-12-30 date: 2024-12-30 date: 2024-03-21 date: 2024-03-21 name: Sun Yat-sen University class: OTHER briefSummary: Atezolizumab + Bevacizumab was superior to sorafenib in overall survival in advanced hepatocellular carcinoma. The programmed cell death protein-1 (PD1) and PDL1 inhibitor, was effective and tolerable in patients with advanced hepatocellular carcinoma. We aimed to describe the efficacy and safety of locoregional therapy combined with Bevacizumab and PD1/L1 inhibitor in patients with advanced hepatocellular carcinoma who can not receive radical therapy. conditions: Advanced Hepatocellular Carcinoma conditions: Anti-PD1/PDL1 Antibody conditions: Bevacizumab studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 240 type: ESTIMATED name: Locoregional therapy name: Bevacizumab name: Atezolizumab name: Tislelizumab name: Toripalimab name: Sintilimab name: Camrelizumab measure: Progression-Free-Survival (PFS) measure: Overall survival (OS) measure: Objective response rate (ORR) measure: Adverse events sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese PLA hospital status: RECRUITING city: Beijing state: Beijing zip: 100853 country: China name: Qunfang Zhou, Md role: CONTACT phone: 8619868000115 email: zhouqun988509@163.com name: MD role: CONTACT phone: 8613910984586 email: duanfeng@vip.sina.com name: Feng Duan, MD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06323369 id: SYSKY-2023-1283-02 briefTitle: Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Clinically Node-negative Head and Neck Squamous Cell Carcinoma overallStatus: RECRUITING date: 2024-03-25 date: 2029-03-25 date: 2029-09-25 date: 2024-03-21 date: 2024-03-21 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: A prospective, randomized, open-label, multicenter Phase 2 trial designed to compare the efficacy and safety of Tislelizumab combined with chemotherapy followed by surgery versus up-front surgery in resectable clinically node-negative head and neck squamous cell carcinoma. conditions: Head and Neck Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 154 type: ESTIMATED name: Tislelizumab（neoadjuvant） name: Cisplatin （neoadjuvant） name: Nab-paclitaxel （neoadjuvant） name: Surgical resection name: Cisplatin（adjuvant） name: Tislelizumab（adjuvant） name: Radiation name: Carboplatin（neoadjuvant） name: Carboplatin（adjuvant） measure: Disease-Free Survival(DFS ) measure: Lymph node positivity rate measure: Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Adverse Events measure: Pathological complete response (pCR) rate measure: Major Pathological Response (MPR) rate measure: lymph node division measure: Event-free Survival (EFS) measure: Overall survival (OS) measure: Disease-Free Survival(DFS ) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Ethics Committee of Sun Yat-sen Memorial Hospital status: RECRUITING city: Guangzhou state: Yuexiu zip: 510120 country: China name: Song Fan, Doctor role: CONTACT phone: 13570536658 phoneExt: +86 email: fansong2@mail.sysu.edu.cn name: Song Fan, Doctor role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06323356 id: TAK-279-PsO-3005 id: jRCT2031230714 type: REGISTRY domain: jRCT briefTitle: A Study of TAK-279 in Adult Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis overallStatus: RECRUITING date: 2024-03-19 date: 2025-06-30 date: 2026-03-27 date: 2024-03-21 date: 2024-04-10 name: Takeda class: INDUSTRY briefSummary: The main aim of this study is to check if TAK-279 improves symptoms of With Generalized Pustular Psoriasis (GPP) or Erythrodermic Psoriasis (EP) and side effect from the study treatment or TAK-279.
All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules.
Participants will be in the study for up to 61 weeks including 52 weeks of study treatment. During the study, participants will visit their study clinic for multiple times. conditions: Generalized Pustular Psoriasis conditions: Erythrodermic Psoriasis studyType: INTERVENTIONAL phases: PHASE3 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: TAK-279 measure: Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 measure: Percentage of Participants Achieving ≥75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16 measure: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 52 measure: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Both Week 16 and Week 52 Visits measure: Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 and Week 52 measure: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) at Week 16 and Week 52 measure: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) at Week 16 and Week 52 Visits measure: Percentage of Participants Achieving PASI-75 at Week 52 measure: Percentage of Participants Achieving PASI-90 at Week 16 and Week 52 measure: Percentage of Participants Achieving PASI-100 at Week 16 and Week 52 measure: Percentage of Participants Achieving PASI-75 at Both the Week 16 and Week 52 Visits measure: Percentage of Participants Achieving PASI-90 at Both the Week 16 and Week 52 Visits measure: Percentage of Participants Achieving a Scalp-specific Physician's Global Assessment (ssPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 and Week 52 measure: Change from baseline in ssPGA at Weeks 16 and 52 measure: Percentage of Participants Achieving a PGA of the Hands and/or Feet of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Weeks 16 and Week 52 measure: Percentage of Participants with a Baseline Dermatology Life Quality Index (DLQI) Score ≥2 who Achieve DLQI Score of 0 or 1 at Week 16 and Week 52 measure: Change from Baseline in DLQI at Week 16 and Week 52 measure: Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 and Week 52 Among Participants with Nail Involvement at Baseline measure: Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 and Week 52 measure: Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a Generalized Pustular Psoriasis Global Assessment (GPPGA) Pustulation Subscore of No Visible Pustules (0) at Week 16 and Week 52 measure: Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a GPPGA of Clear (0) or Almost Clear (1) at Weeks 16 and Week 52 measure: Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a GPPGA of Clear (0) at Week 16 and Week 52 measure: Percentage of Participants with Generalized Pustular Psoriasis Who Achieve ≥75% Improvement from Baseline in Generalized Pustular Psoriasis Area and Severity Index (GPPASI) Score at Week 16 and Week 52 measure: Change from Baseline in Japanese Dermatological Association Severity Index (JDASI) Score at Week 16 and Week 52 for Participants with Generalized Pustular Psoriasis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nagoya City University Hospital status: NOT_YET_RECRUITING city: Nagoya state: Aichi country: Japan lat: 35.18147 lon: 136.90641 facility: Fujita Health University Hospital status: NOT_YET_RECRUITING city: Toyoake state: Aichi country: Japan lat: 35.038 lon: 136.99931 facility: Kimitsu Chuo Hospital status: RECRUITING city: Kisarazu state: Chiba country: Japan lat: 35.38329 lon: 139.93254 facility: Juntendo University Urayasu Hospital status: NOT_YET_RECRUITING city: Urayasu state: Chiba country: Japan lat: 35.67054 lon: 139.88862 facility: Hospital of the University of Occupational and Environmental Health, Japan status: RECRUITING city: Kitakyushu state: Fukuoka country: Japan lat: 33.85181 lon: 130.85034 facility: Isesaki Municipal Hospital status: NOT_YET_RECRUITING city: Isesaki state: Gunma country: Japan lat: 36.31667 lon: 139.2 facility: Kobe University Hospital status: NOT_YET_RECRUITING city: Kobe state: Hyogo country: Japan lat: 34.6913 lon: 135.183 facility: Tokai University Hospital status: NOT_YET_RECRUITING city: Isehara state: Kanagawa country: Japan lat: 35.39932 lon: 139.31019 facility: Mie University Hospital status: NOT_YET_RECRUITING city: Tsu state: Mie country: Japan lat: 34.73333 lon: 136.51667 facility: Kansai Medical University Hospital status: NOT_YET_RECRUITING city: Hirakata state: Osaka country: Japan lat: 34.81352 lon: 135.64914 facility: Saitama Medical University Hospital status: NOT_YET_RECRUITING city: Iruma state: Saitama country: Japan facility: St.Luke's International Hospital status: NOT_YET_RECRUITING city: Chuo City state: Tokyo country: Japan lat: 35.57779 lon: 139.71685 facility: Teikyo University Hospital status: NOT_YET_RECRUITING city: Itabashi-ku state: Tokyo country: Japan lat: 35.74893 lon: 139.71497 facility: The Jikei University Hospital status: NOT_YET_RECRUITING city: Minato-ku state: Tokyo country: Japan lat: 34.2152 lon: 135.1501 facility: Tokyo Medical University Hospital status: NOT_YET_RECRUITING city: Shinjuku-ku state: Tokyo country: Japan lat: 35.2946 lon: 139.57059 facility: Fukuoka University Hospital status: NOT_YET_RECRUITING city: Fukuoka country: Japan lat: 33.6 lon: 130.41667 facility: University Hospital, Kyoto Prefectural University of Medicine status: NOT_YET_RECRUITING city: Kyoto country: Japan lat: 35.02107 lon: 135.75385 facility: Okayama University Hospital status: NOT_YET_RECRUITING city: Okayama country: Japan lat: 34.65 lon: 133.93333 facility: Nippon Life Hospital status: NOT_YET_RECRUITING city: Osaka country: Japan lat: 34.69374 lon: 135.50218 facility: Osaka Metropolitan University Hospital status: NOT_YET_RECRUITING city: Osaka country: Japan lat: 34.69374 lon: 135.50218 hasResults: False
<\|newrecord\|> nctId: NCT06323343 id: 00040976 briefTitle: Mobile Video Education to Improve Patient Clinician Communication During Prenatal Clinic Visits overallStatus: NOT_YET_RECRUITING date: 2024-05-28 date: 2024-10-01 date: 2025-01-31 date: 2024-03-21 date: 2024-03-21 name: Medical College of Wisconsin class: OTHER briefSummary: The goal of this clinical trial is to test an animated video delivered by text message in patients whose pregnancies are complicated with fetal anomalies. The main question it aims to answer is: Does the video intervention prepare parents to talk to the doctors during prenatal appointments?
Participants will be randomized to receive either the video intervention or links to the clinic's webpages. They will complete an enrollment survey before their appointment and a follow up survey after their appointment.
The researchers will compare the video and webpage groups to see which group reports engaging in more of the identified best-practices of communication. conditions: Patient Empowerment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 114 type: ESTIMATED name: Video Intervention name: Webpage links measure: Parents' communication behaviors measure sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06323330 id: I-1623 briefTitle: Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-10-31 date: 2026-11-30 date: 2024-03-21 date: 2024-03-21 name: All India Institute of Medical Sciences, New Delhi class: OTHER name: Institute of Human Behavior and Allied Sciences name: Indian Institute of Technology, New Delhi name: Vardhman Mahavir Medical College And Safdarjung Hospital briefSummary: The goal of this Interventional Study is to develop and test the Indian Adaptation of Melodic Intonation Therapy (MIT) for Indian patients in with post-stroke Non-Fluent Aphasia (PSNFA). The main question\[s\] it aims to answer are: • To develop the MIT Indian Adaptation tool and check its feasibility • To compare the MIT with standard speech rehabilitation in patient with PSNFA. Participants will undergo Speech Rehabilitation according to the developed module and the standard treatment will be given in the comparator arm. The speech recovery at 12 weeks will be compared in both treatment arms. conditions: Stroke Rehabilitation conditions: Aphasia, Broca studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The MIT- Indian Adaptation will be tested and compared with standard speech rehabilitation in post-stroke non-fluent aphasia primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The outcome assessor will be blinded to the intervention whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Speech rehabilitation measure: Western Aphasia Battery Score measure: Western Aphasia Battery Score measure: functional Near Red Spectroscopy measures measure: modified Rankin Score measure: Fugl Meyer Assessment Scores sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06323317 id: UW 21-405 briefTitle: A Prehabilitation Program for Frail Patients Undergoing Cardiac Surgeries/Procedures acronym: PREHAB overallStatus: RECRUITING date: 2023-12-18 date: 2024-12-31 date: 2025-03-31 date: 2024-03-21 date: 2024-03-21 name: The University of Hong Kong class: OTHER briefSummary: The purpose of this study is to develop and evaluate a frailty-specific prehabilitation program for patients awaiting cardiac surgeries/procedures. The program aims to improve functional capacity, frailty level, cardiac-related physical functioning, health-related quality of life (HRQoL), psychological distress, major adverse cardiovascular and cerebral events (MACCE), hospital length of stay, and readmission rates.
Cardiovascular disease is a leading cause of disability and morbidity globally, particularly in older adults. Frailty, a geriatric syndrome commonly seen in cardiac patients, complicates their perioperative care and leads to worse outcomes.
Prehabilitation, which optimizes patients' physiological and functional capacities before surgery, has shown promise in general cardiac patients but requires a more comprehensive approach for frail individuals. This randomized controlled trial will recruit 50 Chinese adults awaiting elective cardiac surgeries/procedures in Hong Kong. Participants will be randomly assigned to either the intervention group, receiving a comprehensive prehabilitation program, or the control group, receiving routine preoperative care. Assessments will be conducted at baseline and at three postoperative time points.
The findings will contribute to our understanding of the impact of frailty on postoperative outcomes and help develop strategies to improve patient care. Ultimately, this study aims to reduce healthcare burdens associated with cardiac disease-related morbidity and disability. conditions: Coronary Artery Bypass Grafting conditions: Heart Valve Replacement conditions: Transcatheter Aortic Valve Implantation conditions: Frailty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The post-intervention data collector (research assistant) will be blinded to the group allocation to avoid performance and detection biases. whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Multi-component exercise programme name: Attention Placebo name: Structured preoperative education name: Nutritional optimization name: Stress management measure: The Short Physical Performance Battery (SPPB) measure: Weakness/ Grip Strength (Fried Phenotype Frailty Assessment) measure: Slowness (Fried Phenotype Frailty Assessment) measure: Low Physical Activity (Fried Phenotype Frailty Assessment) measure: Self-reported Exhaustion (Fried Phenotype Frailty Assessment) measure: Unintentional Weight Loss (Fried Phenotype Frailty Assessment) measure: The Seattle Angina Questionnaire (SAQ) measure: The MacNew Heart Disease Health-Related Quality of Life Questionnaire measure: The Hospital Anxiety and Depression Scale (HADS) measure: Biomarkers-Serum albumin measure: Biomarkers- C-reactive protein measure: Major adverse cardiac and cerebrovascular events (MACCE) measure: Hospital Length of stay measure: Hospital Readmissions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Polly Wai Chi status: RECRUITING city: Hong Kong state: Please Select zip: 00000 country: Hong Kong name: Polly Wai Chi Li, PhD role: CONTACT email: pwcli@hku.hk lat: 22.27832 lon: 114.17469 hasResults: False
<\|newrecord\|> nctId: NCT06323304 id: 701/HDDD-DHYD briefTitle: Efficacy and Safety of Auricular Acupressure in Treating Allergic Rhinitis overallStatus: RECRUITING date: 2024-03-13 date: 2024-06 date: 2024-06 date: 2024-03-21 date: 2024-04-04 name: University of Medicine and Pharmacy at Ho Chi Minh City class: OTHER briefSummary: Allergic rhinitis (AR) is a global health problem affecting approximately 10% to 40% of the population worldwide, with an increasing trend. It significantly impacts health and quality of life. Current treatments for AR include allergen avoidance, symptom-relieving medications, anti-inflammatory therapy, and allergen-specific immunotherapy. However, many patients still experience uncontrolled symptoms despite these approaches, either as monotherapy or in combination, along with medication side effects such as drowsiness, dry eyes, nasal mucosal damage, and immunosuppression.
Auricular acupressure therapy (AAT) utilizes ear acupoints by applying pressure with ear seeds. The neurobiological mechanisms of AAT on the human body have gained increasing attention in clinical and experimental studies, involving anti-inflammatory, antioxidant, and immunomodulatory effects. Its efficacy has been recognized, becoming a potential alternative therapy for various conditions such as sleep disorders, obesity, and chronic pain. Previous clinical studies have reported the efficacy and safety of AAT in treating AR. However, the primary outcomes of these studies remain inconsistent and lack specific criteria for evaluating AR treatment efficacy.
This study aims to investigate the efficacy and safety of AAT in treating AR based on the ARIA guideline 2019 treatment efficacy criteria. It will provide a basis for applying AAT as a complementary approach in the multimodal treatment of AR. conditions: Itching conditions: Runny Nose conditions: Sneezing conditions: Nasal Congestion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Triple-blind method (Participant, Investigator, Outcome assessor) Participants will be blinded to their randomization assignment, either to the intervention group or the control group. Sham acupressure therapy will be performed at acupoints that have no therapeutic effect on allergic rhinitis, and the procedures will be similar to auricular pressure therapy. Both groups will be treated with fluticasone propionate nasal spray, which is the standard treatment.
The physician who perform auricular acupressure therapy or sham acupressure therapy will be aware of the intervention assignment for each group, but they will not be involved in data analysis or outcome assessment. The data analysts and outcome assessors will be blinded to the treatment assignment. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Auricular acupressure name: Sham acupressure name: Standard treatment measure: The change of nasal and non nasal symptom scores measure: The change of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score measure: The change of relief medication usage measure: Proportion of intervention-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: University of Medical Center HCMC - Branch no.3 status: RECRUITING city: Ho Chi Minh zip: 700000 country: Vietnam name: Chau Ngoc Le, MD role: CONTACT phone: +84942831722 email: lnchau.ntyhct21@ump.edu.vn name: Minh-Man Pham Bui, MD role: CONTACT phone: +84916080803 email: bpmman@ump.edu.vn lat: 10.82302 lon: 106.62965 hasResults: False
<\|newrecord\|> nctId: NCT06323291 id: MCC-23077 briefTitle: Cancer Coaching and Remote Education for Self-Empowerment (CARES) Study overallStatus: RECRUITING date: 2024-04-01 date: 2026-03 date: 2026-03 date: 2024-03-21 date: 2024-04-12 name: H. Lee Moffitt Cancer Center and Research Institute class: OTHER name: Canopy Cancer Collective briefSummary: This Pilot Study will evaluate a 12-week pilot program that offers digital health coaching for individuals with pancreatic cancer and their caregivers. conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 20 type: ESTIMATED name: Coaching Sessions measure: Recruitment Rate measure: Participant Acceptance of the Digital Health Coaching Program measure: Participant Ease of Usability of the Digital Health Coaching Program measure: Feasibility of Utilizing the Digital Health Coaching Program sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Moffitt Cancer Center status: RECRUITING city: Tampa state: Florida zip: 33612 country: United States name: Emma Hume role: CONTACT phone: 813-745-6426 email: Emma.Hume@moffitt.org name: Kea Turner, MPH, PhD role: PRINCIPAL_INVESTIGATOR name: Pamela Hodul, MD role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 hasResults: False
<\|newrecord\|> nctId: NCT06323278 id: PD&REHAB briefTitle: Effectiveness of Cognitive Stimulation Treatment in Patients With Parkinson's Disease overallStatus: RECRUITING date: 2021-12-21 date: 2026-12 date: 2027-12 date: 2024-03-21 date: 2024-03-21 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: The goal of this observational study is to evaluate the relationship between GBA mutation and cognitive stimulation treatment response in patients with Parkinson's disease. The main questions it aim to answer are: • assess whether the GBA mutation is associated with greater or lesser response to cognitive training treatment compared to a control group of PD patients without genetic mutations. • investigate the effect of cognitive stimulation program on behavioural aspects as secondary consequence induced by the possible improvement of cognitive abilities following treatment.
Participants will be undergo to: - a neuropsychological evaluation describing their cognitive profile; - a genetic investigation and finally included in a cognitive stimulation programs according to regular clinical practice. Researchers will compare PD patients with GBA mutation and patients without genetic mutation to evaluate the effectiveness of cognitive stimulation treatment. conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 68 type: ESTIMATED name: Cognitive training measure: Efficacy of the cognitive training on cognitive function in PD patients with GBA mutation compared to a control group of PD patients without genetic mutations. measure: The effect of cognitive training on behavioural aspects in PD patients. measure: The effect of cognitive training on behavioural aspects in PD patients. measure: The effect of cognitive training on behavioural aspects in PD patients. measure: The effect of cognitive training on behavioural aspects in PD patients. measure: The effect of cognitive training on behavioural aspects in PD patients. measure: The effect of cognitive training on behavioural aspects in PD patients. measure: The effect of cognitive training on behavioural aspects in PD patients. measure: The effect of cognitive training on behavioural aspects in PD patients. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: RECRUITING city: Milan country: Italy name: Fabiana Ruggiero, MSc in Psychology role: CONTACT phone: +390255033621 email: fabiana.ruggiero@policlinico.mi.it lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06323265 id: ARL-SCLC-001 briefTitle: A Real-world Study of Adebrelimab Combined With Chemotherapy±Chest Radiotherapy in Patients With Extensive Stage Small Cell Lung Cancer overallStatus: RECRUITING date: 2024-03-26 date: 2025-04-01 date: 2026-04-01 date: 2024-03-21 date: 2024-03-27 name: Hebei Medical University Fourth Hospital class: OTHER briefSummary: The purpose of this study is to assess efficacy and safety of patients who receive Adebrelimab combined with chemotherapy±chest radiotherapy as first-line treatment of extensive stage small cell lung cancer in the real world. conditions: Extensive Stage Small Cell Lung Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Adebrelimab + chemotherapy name: ±chest radiotherapy measure: Progression free survival (PFS) measure: Objective response rate (ORR) measure: Disease control rate (DCR) measure: Duration of Overall Response（DoR） measure: Overall survival (OS) measure: Adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jun Wang status: RECRUITING city: Shijiazhuang state: Hebei country: China name: Jun Wang role: CONTACT phone: 13931182128 email: wangjunzr@163.com lat: 38.04139 lon: 114.47861 hasResults: False
<\|newrecord\|> nctId: NCT06323252 id: MastihaOil-HT briefTitle: A Study on the Effects of Mastiha Oil in Adults With Hypertriglyceridemia overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-10-30 date: 2025-10-30 date: 2024-03-21 date: 2024-03-21 name: Harokopio University class: OTHER briefSummary: Mastiha Oil is a 100% natural product of the Mediterranean, extracted from the resin of Mastiha. Its composition is high in bioactive ingredients (such as terpenic acids and polyphenols) which have proven anti-inflammatory, antioxidant, cardioprotective, chemoprotective and antimicrobial properties. The aim of this study is to determine the effect of Mastiha oil in adults with Hypetriglyceridemia. 100 participants will be allocated to two groups, (50 in intervention group and 50 in control group). Mastiha oil will be provided in the form of soft gel capsules to the intervention group, whereas the control group will not consume the capsules. Both groups will receive standard nutritional counselling. The intervention will last 3 months.
The effects of the intervention will be evaluated via clinical and laboratory markers. conditions: Hypertriglyceridemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: MastihaOil name: nutritional counsel measure: Change in blood triglycerides sex: ALL minimumAge: 30 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06323239 id: SBRT/LDRT+PD-1+GP for r/mNPC briefTitle: SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2028-04-01 date: 2024-03-21 date: 2024-03-21 name: Sun Yat-sen University class: OTHER briefSummary: This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients. conditions: Nasopharyngeal Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 148 type: ESTIMATED name: SBRT name: Low-dose Radiotherapy (LDRT) name: Toripalimab name: Gemcitabine name: Cisplatin name: IMRT measure: Progression-free survival measure: Overall Survival measure: Objective Response Rate measure: Disease Control Rate measure: Adverse Events measure: QoL sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06323226 id: 2024-312-1 briefTitle: The Impact of Sepsis on Long-term Outcomes in Critical Ill Children With Sepsis overallStatus: RECRUITING date: 2019-01-01 date: 2025-01-01 date: 2025-06-01 date: 2024-03-21 date: 2024-03-21 name: West China Hospital class: OTHER briefSummary: This study is conducted in critically ill children with sepsis with a five years follow-up. We aim to investigate the impact of sepsis on long-term outcomes including growth, neurodevelopment, survival rate, quality of life. conditions: Sepsis conditions: Children, Only studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: Mortality sex: ALL minimumAge: 0 Years maximumAge: 16 Years stdAges: CHILD facility: West China Hospital of Sichuan University status: RECRUITING city: Chendu state: Sichuan country: China name: Ji Yi, Doctor role: CONTACT hasResults: False
<\|newrecord\|> nctId: NCT06323213 id: SSGJ-610-BA-III-01 briefTitle: Efficacy and Safety Study of 610 in Patients With Severe Asthma overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-06 date: 2026-09 date: 2024-03-21 date: 2024-03-21 name: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. class: INDUSTRY briefSummary: The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma. conditions: Asthma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 480 type: ESTIMATED name: 610 name: Placebo measure: Annualized rate of severe exacerbation events measure: Time to first severe exacerbation event measure: Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit measure: Change from baseline in ACQ score measure: Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ) measure: Change in pre-bronchodilator forced expiratory volume (FEV1) measure: Assessment of adverse events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06323200 id: 202400221B0 briefTitle: Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA acronym: LVA overallStatus: COMPLETED date: 2015-09 date: 2023-03 date: 2023-03 date: 2024-03-21 date: 2024-03-21 name: Chang Gung Memorial Hospital class: OTHER briefSummary: This study aimed to address the impact of lymphedema duration on the quality of lymphatic vessels as well as the outcome after LVA using propensity score matching. conditions: Lymphedema studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 189 type: ACTUAL name: lymphaticovenous anastomosis measure: Volume change after LVA. sex: ALL minimumAge: 20 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06323187 id: 4656 briefTitle: Optimization of Cervical Collections in Pregnancy acronym: OCCP overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-02-28 date: 2031-02-28 date: 2024-03-21 date: 2024-03-21 name: Dr. Sascha Drewlo class: OTHER briefSummary: Fetal cells are not easily obtained from pregnant patients; this curtails testing to assess the health of the fetus and the mother. Currently, the only way of diagnosing fetal genetic or chromosomal abnormalities is by invasive techniques, such as chorionic villous sampling (CVS) and amniocentesis performed at 10 to 13 weeks and after 15 weeks of gestation, respectively. Although small, there is a risk for fetal loss with these procedures. Transcervical cell sampling (TCS), similar to a Pap smear, is a platform that meets the requirements for prenatal genetic testing (genetic testing with fetal cells obtained before birth), as well as diagnosis of maternal pregnancy complication, at a very early stage of pregnancy (as early as 5 weeks) and carries low risk for the mother and the developing fetus.
This study will examine cervical fluid collected using various noninvasive methods for TCS in pregnant women. The number of placental cells will be assessed against similarly obtained samples from nonpregnant women of reproductive age who lack cells derived from a placenta. Participating volunteers will provide written informed consent. Only standard medical procedures and approved devices will be used for collection of cervical fluid, minimizing risk to the participants and their fetuses. No test results or other benefits will be available to the participants. conditions: Cervix; Pregnancy conditions: Inherited Genetic Conditions (Diagnosis) conditions: Preeclampsia conditions: Fetal Growth Retardation studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 2600 type: ESTIMATED name: Cervical Sampling measure: Cellular content measure: Cell-free content sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06323174 id: NN9388-4895 id: 2022-502677-42 type: OTHER domain: European Medical Agency (EMA) id: U1111-1283-0404 type: OTHER domain: World Health Organization (WHO) briefTitle: A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise acronym: REIMAGINE 1 overallStatus: RECRUITING date: 2024-03-19 date: 2025-08-12 date: 2025-11-04 date: 2024-03-21 date: 2024-04-03 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study will look at how much CagriSema helps participants with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: Cagrilintide name: Semaglutide name: Placebo measure: Change in glycated haemoglobin (HbA1c) measure: Relative change in body weight measure: Number of participants who achieve greater than or equal to (>=) 10% body weight reduction measure: Number of participants who achieve >=15% body weight reduction measure: Number of participants who achieve HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol]) measure: Number of participants who achieve HbA1c target values of less than or equal to (<=) 6.5% (<= 48 mmol/mol) measure: Change in Fasting Plasma Glucose (FPG) measure: Number of participants who achieve >=5% body weight reduction measure: Number of participants who achieve >=20% body weight reduction measure: Change in waist circumference measure: Change in systolic blood pressure (SBP) measure: Change in diastolic blood pressure (DBP) measure: Ratio to baseline in high sensitivity C-reactive protein (hsCRP) 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 measure: Ratio to baseline in lipids: Non-HDL cholesterol measure: Number of participants who achieve type 2 diabetes (T2D) remission (HbA1c <6.5% and no antidiabetic medication) measure: Ratio to baseline in oral glucose tolerance test (OGTT) based oral glucose disposition index (DIo) measure: Change in experienced level of energy as measured by the SF-36v2 Health Survey Acute (SF-36v2) Vitality score measure: Change in SF-36v2 score: Physical Component Summary score measure: Change in SF-36v2 score: Mental Component Summary score measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score measure: Change in leptin measure: Change in soluble leptin receptor measure: Number of Treatment Emergent Adverse Events (TEAEs) measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose (BG) meter measure: Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Research Institute_Huntington Park status: RECRUITING city: Huntington Park state: California zip: 90255 country: United States lat: 33.98168 lon: -118.22507 facility: Valley Clinical Trials, Inc. status: RECRUITING city: Northridge state: California zip: 91325 country: United States lat: 34.22834 lon: -118.53675 facility: Southern California Dermatology status: RECRUITING city: Santa Ana state: California zip: 92701 country: United States lat: 33.74557 lon: -117.86783 facility: Encore Medical Research LLC status: RECRUITING city: Hollywood state: Florida zip: 33021 country: United States lat: 26.0112 lon: -80.14949 facility: Alliance for Multispec Res status: NOT_YET_RECRUITING city: Newton state: Kansas zip: 67114 country: United States lat: 38.04668 lon: -97.34504 facility: Brigham & Women's Hospital status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: Arcturus Healthcare, PLC status: RECRUITING city: Troy state: Michigan zip: 48098 country: United States lat: 42.60559 lon: -83.14993 facility: Holston Medical Group status: RECRUITING city: Kingsport state: Tennessee zip: 37660 country: United States lat: 36.54843 lon: -82.56182 facility: Velocity Clinical Res-Dallas status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States lat: 32.78306 lon: -96.80667 facility: Northeast Clinical Research of San Antonio status: RECRUITING city: San Antonio state: Texas zip: 78233 country: United States lat: 29.42412 lon: -98.49363 facility: Consano Clinical Research, LLC status: RECRUITING city: Shavano Park state: Texas zip: 78231 country: United States lat: 29.58495 lon: -98.55252 facility: Consano Clinical Research, LLC status: NOT_YET_RECRUITING city: Shavano Park state: Texas zip: 78231 country: United States lat: 29.58495 lon: -98.55252 facility: TPMG Clinical Research status: RECRUITING city: Newport News state: Virginia zip: 23606 country: United States lat: 37.08339 lon: -76.46965 facility: Chinese People's Liberation Army General Hospital status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100853 country: China lat: 39.9075 lon: 116.39723 facility: The Second Affiliated Hospital of Nanjing Medical University_Nanjing status: NOT_YET_RECRUITING city: Nanjing state: Jiangsu zip: 210011 country: China lat: 32.06167 lon: 118.77778 facility: The Affiliated Hospital of Jiangsu University_Zhenjiang status: NOT_YET_RECRUITING city: Zhenjiang state: Jiangsu zip: 212001 country: China lat: 32.21086 lon: 119.45508 facility: Jinan Central Hospital status: NOT_YET_RECRUITING city: Ji'Nan state: Shandong zip: 250000 country: China lat: 36.66833 lon: 116.99722 facility: Belinus Bt. status: NOT_YET_RECRUITING city: Debrecen state: Hajdu-Bihar Varmegye zip: 4025 country: Hungary lat: 47.53333 lon: 21.63333 facility: Borbánya Praxis E.Ü. Kft. status: NOT_YET_RECRUITING city: Nyíregyháza state: Szabolcs-Szatmar Varmegye zip: 4405 country: Hungary lat: 47.95539 lon: 21.71671 facility: Azienda Ospedaliera Papa Giovanni XXIII status: NOT_YET_RECRUITING city: Bergamo zip: 24127 country: Italy lat: 45.69601 lon: 9.66721 facility: Policlinico Mater Domini Università di Catanzaro status: NOT_YET_RECRUITING city: Catanzaro zip: 88100 country: Italy lat: 38.88247 lon: 16.60086 facility: IRCCS Ospedale San Raffaele Milano status: NOT_YET_RECRUITING city: Milano zip: 20132 country: Italy lat: 45.46427 lon: 9.18951 facility: Azienda Ospealiero Universitaria Policlinico Umberto I status: NOT_YET_RECRUITING city: Roma zip: 00161 country: Italy lat: 41.89193 lon: 12.51133 facility: Centrum Medyczne Medyk Sp. z o.o. status: NOT_YET_RECRUITING city: Rzeszow state: Podkarpackie zip: 35-055 country: Poland lat: 50.04132 lon: 21.99901 facility: Renew Clinic Bialystok status: NOT_YET_RECRUITING city: Białystok zip: 15-794 country: Poland lat: 53.13333 lon: 23.16433 facility: Centrum Terapii Wspolczesnej status: NOT_YET_RECRUITING city: Lodz zip: 90-338 country: Poland lat: 51.75 lon: 19.46667 facility: NBR Polska Tomasz Klodawski status: NOT_YET_RECRUITING city: Warszawa zip: 00-710 country: Poland lat: 52.22977 lon: 21.01178 facility: King Abdulaziz Hospital-Al Ahsa-National Guard status: NOT_YET_RECRUITING city: Al Ahsa zip: 36428 country: Saudi Arabia facility: National Guard Hospital - Jeddah status: NOT_YET_RECRUITING city: Jeddah zip: 21423 country: Saudi Arabia lat: 21.54238 lon: 39.19797 facility: King Fahad Medical City status: NOT_YET_RECRUITING city: Riyadh zip: 11525 country: Saudi Arabia lat: 24.68773 lon: 46.72185 facility: King Khaled University Hospital,King Saud Univ. Med. City status: NOT_YET_RECRUITING city: Riyadh zip: 12372 country: Saudi Arabia lat: 24.68773 lon: 46.72185 facility: King Salman Bin Abdulaziz Hospital status: NOT_YET_RECRUITING city: Riyadh zip: 12769 country: Saudi Arabia lat: 24.68773 lon: 46.72185 facility: CHC Zvezdara, Clinical department for endocrinology status: NOT_YET_RECRUITING city: Belgrade zip: 11000 country: Serbia lat: 44.80401 lon: 20.46513 facility: Clinical Hospital Center Bezanijska Kosa status: NOT_YET_RECRUITING city: Belgrade zip: 11080 country: Serbia lat: 44.80401 lon: 20.46513 facility: Clinical Hospital Centre Zemun status: NOT_YET_RECRUITING city: Belgrade zip: 11080 country: Serbia lat: 44.80401 lon: 20.46513 hasResults: False
<\|newrecord\|> nctId: NCT06323161 id: NN9388-7637 id: U1111-1283-0754 type: OTHER domain: World Health Organization (WHO) id: 2022-502679-43 type: OTHER domain: European Medical Agency (EMA) briefTitle: A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Once-daily Basal Insulin With or Without Metformin acronym: REIMAGINE 3 overallStatus: RECRUITING date: 2024-03-26 date: 2025-09-16 date: 2025-11-04 date: 2024-03-21 date: 2024-04-22 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study will look at how much CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participant will get either CagriSema or "dummy" medicine and which treatment they get is decided by chance. Participant will take the study medicine together with their current diabetes medicine (once-daily insulin with or without metformin). For each participant, the study will last for about one year. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 270 type: ESTIMATED name: Cagrilintide name: Semaglutide name: Placebo measure: Change in Glycated Haemoglobin (HbA1c) measure: Relative Change in Body Weight measure: Number of Participants Who Achieve Greater than or Equal to (≥) 10% Body Weight Reduction measure: Number of Participants Who Achieve ≥15% Body Weight Reduction measure: Number of Participants Who Achieve HbA1c Target Values of Less than (<) 7.0% (<53 millimole per mole [mmol/mol]) measure: Number of Participants Who Achieve HbA1c Target Values of Less than or Equal to (≤) 6.5% (≤48 mmol/mol) measure: Change in Fasting Plasma Glucose (FPG) measure: Change in Insulin Dose measure: Number of Participants Who Achieve Insulin Dose Equal to (=) 0 Units measure: Change in 7-point Self-measured Plasma Glucose (SMPG) Profiles: Mean 7-point profile and Mean postprandial increment (over all meals) measure: Number of Participants Who Achieve ≥5% Body Weight Reduction measure: Number of Participants Who Achieve ≥20% Body Weight Reduction measure: Change in Waist Circumference measure: Change in Systolic Blood Pressure (SBP) measure: Change in Diastolic Blood Pressure (DBP) measure: Ratio to Baseline in High Sensitivity C-reactive Protein (hsCRP) measure: Ratio to Baseline in Lipids: Non-high Density Lipoprotein (Non-HDL) Cholesterol measure: Ratio to Baseline in Lipids: Triglycerides 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: HDL Cholesterol measure: Ratio to Baseline in Lipids: Total Cholesterol measure: Ratio to Baseline in Lipids: Free Fatty Acids measure: Change in Short Form-36 Version 2.0 Health Survey (SF-36v2): Vitality score measure: Change in SF-36v2: Physical Component Summary Score measure: Change in SF-36v2: Mental Component Summary Core measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score measure: Change in Leptin measure: Change in Soluble Leptin Receptor measure: Number of Treatment Emergent Adverse Events (TEAEs) measure: Number of Clinically Significant Hypoglycaemic Episodes (level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose Meter) measure: Number of Clinically Significant Hypoglycaemic Episodes (level 3) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Valley Clinical Trials, Inc. status: RECRUITING city: Northridge state: California zip: 91325 country: United States lat: 34.22834 lon: -118.53675 facility: Bioclinical Research Alliance status: RECRUITING city: Miami state: Florida zip: 33155 country: United States lat: 25.77427 lon: -80.19366 facility: Solaris Clinical Research status: RECRUITING city: Meridian state: Idaho zip: 83646 country: United States lat: 43.61211 lon: -116.39151 facility: Iowa Diab & Endo Res Center status: RECRUITING city: West Des Moines state: Iowa zip: 50265 country: United States lat: 41.57721 lon: -93.71133 facility: Alliance for Multispec Res status: RECRUITING city: Newton state: Kansas zip: 67114 country: United States lat: 38.04668 lon: -97.34504 facility: Elite Research Center status: RECRUITING city: Flint state: Michigan zip: 48532 country: United States lat: 43.01253 lon: -83.68746 facility: Palm Research Center Inc. status: RECRUITING city: Las Vegas state: Nevada zip: 89128 country: United States lat: 36.17497 lon: -115.13722 facility: University of North Carolina status: NOT_YET_RECRUITING city: Chapel Hill state: North Carolina zip: 27517 country: United States lat: 35.9132 lon: -79.05584 facility: Clinical Research Associates status: RECRUITING city: Nashville state: Tennessee zip: 37203 country: United States lat: 36.16589 lon: -86.78444 facility: Velocity Clinical Res-Dallas status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States lat: 32.78306 lon: -96.80667 facility: Synergy Groups Medical status: RECRUITING city: Houston state: Texas zip: 77061 country: United States lat: 29.76328 lon: -95.36327 facility: PlanIt Research, PLLC status: RECRUITING city: Houston state: Texas zip: 77079 country: United States lat: 29.76328 lon: -95.36327 facility: Manassas Clinical Research Center status: RECRUITING city: Manassas state: Virginia zip: 20110 country: United States lat: 38.75095 lon: -77.47527 facility: TPMG Clinical Research status: RECRUITING city: Newport News state: Virginia zip: 23606 country: United States lat: 37.08339 lon: -76.46965 facility: Chinese People's Liberation Army General Hospital status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100853 country: China lat: 39.9075 lon: 116.39723 facility: The Second Affiliated Hospital of Nanjing Medical University_Nanjing status: NOT_YET_RECRUITING city: Nanjing state: Jiangsu zip: 210011 country: China lat: 32.06167 lon: 118.77778 facility: The Affiliated Hospital of Jiangsu University_Zhenjiang status: NOT_YET_RECRUITING city: Zhenjiang state: Jiangsu zip: 212001 country: China lat: 32.21086 lon: 119.45508 facility: Jinan Central Hospital status: NOT_YET_RECRUITING city: Ji'nan state: Shandong zip: 250013 country: China lat: 36.66833 lon: 116.99722 facility: Shanghai Pudong New Area People's Hospital status: NOT_YET_RECRUITING city: Shanghai state: Shanghai zip: 201200 country: China lat: 31.22222 lon: 121.45806 facility: Manda Memorial Hospital status: NOT_YET_RECRUITING city: Sapporo-shi, Hokkaido state: Hokkaido, Japan zip: 060-0062 country: Japan lat: 43.06667 lon: 141.35 facility: Tsuruma Kaneshiro Diabetes Clinic status: RECRUITING city: Yamato-shi state: Kanagawa zip: 242-0004 country: Japan facility: Kumanomae Nishimura Internal Medical Clinic status: RECRUITING city: Arakawa-ku, Tokyo zip: 116-0012 country: Japan facility: Akaicho Clinic status: RECRUITING city: Chiba-shi, Chiba zip: 260-0804 country: Japan facility: Futata Tetsuhiro Clinic Meinohama status: RECRUITING city: Fukuoka-shi, Fukuoka zip: 819-0006 country: Japan lat: 33.6 lon: 130.41667 facility: Kunisaki Makoto Clinic status: RECRUITING city: Fukuoka-shi, Fukuoka zip: 819-0168 country: Japan lat: 33.6 lon: 130.41667 facility: Sasaki Hospital Internal Medicine status: RECRUITING city: Hokkaido zip: 062-0007 country: Japan lat: 43.41104 lon: 142.88878 facility: Naka Kinen Clinic status: RECRUITING city: Ibaraki zip: 311-0113 country: Japan lat: 34.81641 lon: 135.56828 facility: H.E.C Science Clinic status: NOT_YET_RECRUITING city: Kanagawa zip: 235-0045 country: Japan lat: 37.58333 lon: 139.91667 facility: Minami Akatsuka Clinic status: RECRUITING city: Mito-shi, Ibaraki zip: 311-4153 country: Japan facility: Tokyo-Eki Center-building Clinic status: RECRUITING city: Tokyo zip: 103-0027 country: Japan lat: 35.6895 lon: 139.69171 facility: Tokyo-Eki Center-building Clinic status: NOT_YET_RECRUITING city: Tokyo zip: 103-0027 country: Japan lat: 35.6895 lon: 139.69171 facility: Fukuwa Clinic status: RECRUITING city: Tokyo zip: 104-0031 country: Japan lat: 35.6895 lon: 139.69171 facility: Kato Clinic of Internal Medicine status: RECRUITING city: Tokyo zip: 125-0054 country: Japan lat: 35.6895 lon: 139.69171 facility: Healthcare centre Zvezdara status: NOT_YET_RECRUITING city: Belgrade state: RS zip: 11050 country: Serbia lat: 44.80401 lon: 20.46513 facility: Healthcare centre Kragujevac status: NOT_YET_RECRUITING city: Kragujevac state: RS zip: 34000 country: Serbia lat: 44.01667 lon: 20.91667 facility: University Clinical Centre Nis status: NOT_YET_RECRUITING city: Nis state: RS zip: 18 000 country: Serbia lat: 43.32472 lon: 21.90333 facility: Healthcare centre Nis status: NOT_YET_RECRUITING city: Nis state: RS zip: 18000 country: Serbia lat: 43.32472 lon: 21.90333 facility: Policlinic for diabetes status: NOT_YET_RECRUITING city: Zajecar zip: 19000 country: Serbia lat: 43.90358 lon: 22.26405 facility: MOMED, s.r.o status: RECRUITING city: Kralovsky Chlmec zip: 077 01 country: Slovakia lat: 48.42336 lon: 21.97944 facility: DIA - KONTROL s.r.o. status: RECRUITING city: Levice zip: 93401 country: Slovakia lat: 48.21563 lon: 18.60705 facility: SIN AZUCAR s.r.o. status: RECRUITING city: Malacky zip: 901 01 country: Slovakia lat: 48.43604 lon: 17.02188 facility: ENRIN, s.r.o. status: RECRUITING city: Rimavska Sobota zip: 979 01 country: Slovakia lat: 48.38284 lon: 20.02239 facility: LUDIA, s.r.o. status: RECRUITING city: Spisska Nova Ves zip: 05201 country: Slovakia lat: 48.94464 lon: 20.56153 facility: Vuyo Clinical Research status: NOT_YET_RECRUITING city: Bloemfontein state: Free State zip: 9323 country: South Africa lat: -29.12107 lon: 26.214 facility: Lenasia Clinical Trial Centre status: NOT_YET_RECRUITING city: Lenasia state: Gauteng zip: 1827 country: South Africa lat: -26.32052 lon: 27.83564 facility: Prinshof Medical Campus status: NOT_YET_RECRUITING city: Pretoria state: Gauteng zip: 0002 country: South Africa lat: -25.74486 lon: 28.18783 facility: Clinical Trial Systems (CTC) status: NOT_YET_RECRUITING city: Pretoria state: Gauteng zip: 0186 country: South Africa lat: -25.74486 lon: 28.18783 facility: Ashmed Medi-Centre status: NOT_YET_RECRUITING city: Cape Town state: Western Cape zip: 7760 country: South Africa lat: -33.92584 lon: 18.42322 hasResults: False
<\|newrecord\|> nctId: NCT06323148 id: ECTOP-1022 briefTitle: Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA Non-small Cell Lung Cancer (ECTOP-1022) overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-31 date: 2029-03-31 date: 2024-03-21 date: 2024-03-21 name: Fudan University class: OTHER briefSummary: This study plans to conduct ctDNA testing on EGFR mutation-positive stage II-IIIA (N1-N2) NSCLC patients after radical surgery (R0 resection). Patients with positive ctDNA testing will receive standard treatment according to clinical guidelines, while patients with negative ctDNA testing will be assessed based on comprehensive clinical and pathological characteristics. After receiving or not receiving standard adjuvant chemotherapy, patients will be randomly assigned in a 1:1 ratio to either the observation follow-up group (experimental group) or the osimertinib adjuvant treatment group (control group). The aim is to explore whether observation follow-up for patients with negative ctDNA after surgery has a prognosis non-inferior to osimertinib treatment, and to investigate the disease-free survival rate of EGFR mutation-positive stage II-IIIA (N1-N2) NSCLC patients with positive ctDNA after surgery receiving osimertinib adjuvant treatment, providing more precise treatment guidance for adjuvant therapy in this specific type of NSCLC patients with EGFR mutation-positive tumors. conditions: Lung Cancer conditions: EGFR Gene Mutation conditions: Minimal Residual Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 226 type: ESTIMATED name: Osimertinib name: No adjuvant therapy measure: The 3-year Disease-Free Survival (DFS) rate between the observation group and the osimertinib treatment group. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06323135 id: 2019-725 briefTitle: Nutrition Assessment in Advanced Cancer Patients overallStatus: COMPLETED date: 2019-09-17 date: 2023-09-11 date: 2023-09-11 date: 2024-03-21 date: 2024-03-21 name: West China Hospital class: OTHER briefSummary: The goal of this retrospective observational study is to evaluate the prognostic value of nutrition assessment tool in advanced cancers. We aim to evaluate the clinical utility of nutrition assessment tool in predicting the clinical outcomes of cancer patients, which would help the clinicians to make tailored decision for this population. conditions: Advanced Cancer conditions: Nutrition Aspect of Cancer conditions: Prognostic Cancer Model studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2115 type: ACTUAL measure: All-cause mortality measure: length of stay in hospital sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital, Sichuan Universit city: Chengdu state: Sichuan zip: 610041 country: China lat: 30.66667 lon: 104.06667 hasResults: False
<\|newrecord\|> nctId: NCT06323122 id: Plating Techniques 2023 briefTitle: A Comparative Study Between Three Different Plating Techniques in Management of Mandibular Parasymphyseal Fractures. overallStatus: COMPLETED date: 2021-01-01 date: 2023-10-01 date: 2023-12-01 date: 2024-03-21 date: 2024-03-21 name: October 6 University class: OTHER briefSummary: The main goal in management of mandibular fractures is to restore the pre-injury form and function, with the least disability and shortest recovery period. conditions: Mandibular Fractures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 60 type: ACTUAL name: 2.0 miniplates name: 2.3 high profile miniplates name: 3D miniplates measure: Surgery Time measure: complication measure: fracture stability sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: October 6U city: Cairo zip: 12566 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06323109 id: 2023-1331 id: A196200 type: OTHER domain: UW Madison id: Protocol Version 12/21/23 type: OTHER domain: UW Madison briefTitle: US Imaging for the Assessment of LUTS overallStatus: RECRUITING date: 2023-11-28 date: 2026-01-01 date: 2027-01-01 date: 2024-03-21 date: 2024-03-21 name: University of Wisconsin, Madison class: OTHER name: Wisconsin Partnership Program briefSummary: The purpose of this research is to develop an ultrasound (US) based urodynamics (UDS) evaluation of voiding based on successful magnetic resonance imaging (MRI)-UDS evaluation. Both US and MRI are non-invasive imaging techniques, but US is a more cost-effective and widely available technology. 80 participants will be enrolled and will be on study for up to 2.5 hours (1.5 hour MRI and 1 hour US). conditions: Lower Urinary Tract Symptoms conditions: BPH studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: MRI-UDS; US-UDS; MCUD measure: MRI Urodynamics - Change in Bladder Volume measure: MRI Urodynamics - Change in Urine Velocity measure: MRI Urodynamics - Change in Pressure measure: Bladder outlet obstruction index (BOOI) measure: Bladder contractility index (BOI) measure: International Prostate Symptom Score (IPSS) sex: MALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Wisconsin status: RECRUITING city: Madison state: Wisconsin zip: 53705 country: United States name: Gemma Gliori, MS role: CONTACT email: ggliori@uwhealth.org name: Suzanne Hanson, BS role: CONTACT email: shanson@uwhealth.org name: Alejandro Roldan-Alzate, PhD role: PRINCIPAL_INVESTIGATOR name: Wade Bushman, MD, PhD role: SUB_INVESTIGATOR name: Matt Grimes, MD role: SUB_INVESTIGATOR name: Giuseppe Toia, MD role: SUB_INVESTIGATOR name: Ivan Rosado-Mendez, PhD role: SUB_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False
<\|newrecord\|> nctId: NCT06323096 id: AR13067824 briefTitle: Development of Clinical Decision Support System for Severe Patients With Polytrauma overallStatus: RECRUITING date: 2020-12-01 date: 2024-09-01 date: 2024-12-31 date: 2024-03-21 date: 2024-03-21 name: Semey State Medical University class: OTHER name: Ministry of Science and Higher Education of the Republic of Kazakhstan briefSummary: The goal of this observational study is to develop a Clinical Decision Support System for severe patients with polytrauma. The main questions it aims to answer are:
* Is it possible to predict the development of systemic inflammatory response syndrome for the next 24 h after admission?
* Is it possible to predict the development of blood loss \>25% of blood volume for the next 24 h after admission?
* Is it possible to predict the development of acute traumatic coagulopathy for the next 24 h after admission?
* Is it possible to predict the development of pneumonia in polytrauma patients?
* Is it possible to predict the outcome in polytrauma patients?
No intervention is planned for this study. conditions: Polytrauma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 500 type: ESTIMATED measure: Prediction of SIRS measure: Rate of ATC prediction in the 24 h after admission using the developed CDSS. measure: Rate of hemorrage prediction in the 24 h after admission using the developed CDSS. measure: Rate of pneumonia prediction using the developed CDSS. sex: ALL minimumAge: 28 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emergency Hospital status: RECRUITING city: Semey state: Abai zip: 071400 country: Kazakhstan name: Alexander Prokazyuk, MD role: CONTACT phone: +77071891849 email: prokazyuk.md@yandex.ru lat: 50.42675 lon: 80.26669 hasResults: False
<\|newrecord\|> nctId: NCT06323083 id: 006 briefTitle: The Effect of Emotional Freedom Technique on Perceived Stress and General Self-Efficacy in Nursing Students overallStatus: COMPLETED date: 2022-11-07 date: 2022-11-28 date: 2023-06-30 date: 2024-03-21 date: 2024-03-21 name: Selcuk University class: OTHER briefSummary: The study was conducted to determine the effect of Emotional Freedom Technique (EFT) on perceived stress and general self-efficacy in obstetrics and gynecology nursing lesson in undergraduate nursing students with fear of birth.
The samples were applied to undergraduate nursing students satisfying the research criteria in a state university nursing faculty in Konya at November 2022. conditions: Emotion Regulation conditions: Stress conditions: Self Efficacy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study was designed to be randomly controlled. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ACTUAL name: Emotional Freedom Technique measure: General Self-Efficacy Scale measure: Perceived Stress Scale measure: The Subjective Units of Distress Scale sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Selcuk University city: Konya country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
<\|newrecord\|> nctId: NCT06323070 id: HS-2023-0281 briefTitle: Effects of Watermelon or Low-fat Cookie Consumption on Wellness overallStatus: RECRUITING date: 2024-03-01 date: 2025-12 date: 2025-12 date: 2024-03-21 date: 2024-03-22 name: San Diego State University class: OTHER briefSummary: The objective of the proposed research is to determine the effects of fresh watermelon consumption on physiological indicators of wellness regarding sexual, skin and gut health in adults. conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: Low-fat cookies name: Watermelon measure: Change of sexual health questionnaire scores measure: Change of skin hydration scores measure: Change of microbiome diversity measure: Change of depression questionnaire scores sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: School of Exercise and Nutritional Sciences status: RECRUITING city: San Diego state: California zip: 92182 country: United States name: Mee Young Hong, PhD role: CONTACT phone: 619-594-2392 email: mhong2@sdsu.edu lat: 32.71533 lon: -117.15726 hasResults: False
<\|newrecord\|> nctId: NCT06323057 id: Pro2022000444_CLFMT briefTitle: Modulating Reward Learning Using Transcranial Magnetic Stimulation overallStatus: RECRUITING date: 2024-02-14 date: 2025-04-30 date: 2025-04-30 date: 2024-03-21 date: 2024-03-22 name: Rutgers, The State University of New Jersey class: OTHER briefSummary: Our specific aim is to examine the effects of TMS on reward processing during goal-directed behavior. In these experiments the investigators will utilize a scalp-recorded brain oscillation called frontal midline theta that is believed to index the sensitivity of the cingulate cortex to reward feedback. Here the investigators will asked whether this electrophysiological signal can be modulated up or down using TMS while participants engage in decision making tasks, and if so, whether it would affect the encoding of rewards and subsequent choices during task performance. conditions: Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Participants will be blinded to the TMS condition (active or sham) whoMasked: PARTICIPANT count: 28 type: ESTIMATED name: Single pulse TMS to the frontal cortex measure: Event-related Brain Oscillation: Frontal Midline Theta measure: Reward learning sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Rutgers University - Newark status: RECRUITING city: Newark state: New Jersey zip: 07102 country: United States name: Travis E Baker, PhD role: CONTACT phone: 862-250-3351 email: travis.e.baker@rutgers.edu name: Daniel Robles, PhD role: CONTACT phone: 973-353-3509 email: dr1147@newark.rutgers.edu lat: 40.73566 lon: -74.17237 hasResults: False
<\|newrecord\|> nctId: NCT06323044 id: I-3920723 id: NCI-2024-01734 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: I-3920723 type: OTHER domain: Roswell Park Cancer Institute id: R01CA283501 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA283501 briefTitle: MedSupport Intervention to Identify and Address Barriers to Pediatric Medication Adherence overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2029-06-15 date: 2029-06-15 date: 2024-03-21 date: 2024-04-03 name: Roswell Park Cancer Institute class: OTHER briefSummary: This clinical trial identifies and addresses barriers to pediatric medication adherence among families of children with acute lymphoblastic leukemia. Pediatric nonadherence (noncompliance) to medication is a significant public health problem, and rigorous research repeatedly documents that nonadherence increases risk for hospitalization, healthcare cost, disease progression, and death. Pediatric acute lymphoblastic leukemia (ALL) patients who miss 5% of 6-mercaptopurine (6-MP) doses within the 2-year 6-MP regimen have a 2.7-fold risk of cancer that comes back after a period of improvement (relapse). To address these families' needs, researchers have developed MedSupport, a theory-based multilevel intervention with targets at the organizational, healthcare team, and caregiver levels that is designed to address root barriers to medication adherence. This study is being done to better understand families' experiences giving their child oral chemotherapy at home and to help families cope with the day-to-day challenges of giving their child medication. conditions: Acute Lymphoblastic Leukemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ESTIMATED name: Best Practice name: Biospecimen Collection name: Electronic Health Record Review name: Interview name: Medical Device Usage and Evaluation name: Medical Device Usage and Evaluation name: Survey Administration measure: Medication adherence sex: ALL minimumAge: 365 Days stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Roswell Park Cancer Institute city: Buffalo state: New York zip: 14263 country: United States name: Kara M. Kelly role: CONTACT phone: 716-845-2333 email: Kara.Kelly@RoswellPark.org name: Kara M. Kelly role: PRINCIPAL_INVESTIGATOR lat: 42.88645 lon: -78.87837 hasResults: False
<\|newrecord\|> nctId: NCT06323031 id: Blink-DoC briefTitle: Spontaneous Eye Blinking in Disorders of Consciousness acronym: Blink-DoC overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-11 date: 2024-03-21 date: 2024-03-21 name: Fondazione Don Carlo Gnocchi Onlus class: OTHER name: Therapiezentrum Burgau name: University of Liege name: University Hospital Munich name: VITHAS Valencia (Spain) name: Azienda Ospedaliera Universitaria Ferrara name: Ludwig-Maximilians - University of Munich briefSummary: Differential diagnosis between Unresponsive Wakefulness Syndrome (UWS) and Minimally Conscious State (MCS) is complicated due to severe cognitive and/or sensorimotor deficits in these patients. In this study the investigators aimed at exploring the diagnostic and prognostic validity of spontaneous eye blinking parameters (rate, amplitude, duration, variability) in a sample of patients with Disorders of Consciousness (DoC).
This is a multi-center prospective observational study conducted in patients with Severe Acquired Brain Injury (sABI) and DoC admitted to 8 European participating centers, with clinical data collection not deviating from routine practice. The study is non-commercial and will have a maximum total duration of 24 months. conditions: Disorders of Consciousness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 70 type: ESTIMATED measure: Clinical Diagnosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Coma Science Group, GIGA-Consciousness, University of Liege city: Liege zip: 4000 country: Belgium name: Olivia Gosseries, PhD role: CONTACT email: ogosseries@uliege.be name: Olivia Gosseries, PhD role: PRINCIPAL_INVESTIGATOR name: Aurore Thibaut, PhD role: SUB_INVESTIGATOR name: Youssra Mezoudi, M.Sc. role: SUB_INVESTIGATOR lat: 50.63373 lon: 5.56749 facility: Therapiezentrum Burgau city: Burgau zip: 89331 country: Germany name: Andreas Bender, MD role: CONTACT email: a.bender@therapiezentrum-burgau.de name: Andreas Bender, MD role: PRINCIPAL_INVESTIGATOR name: Martin Rosenfelder, PhD role: SUB_INVESTIGATOR lat: 48.43159 lon: 10.40989 facility: Dipartimento di Neurologia, LMU Hospital, LMU Munich city: Munich zip: 81377 country: Germany name: Konstantinos Dimitriadis role: CONTACT email: konstantin.dimitriadis@med.unimuenchen.de name: Konstantinos Dimitriadis role: PRINCIPAL_INVESTIGATOR name: Moritz Schmidbauer role: SUB_INVESTIGATOR name: Julia Zibold role: SUB_INVESTIGATOR lat: 48.13743 lon: 11.57549 facility: Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS city: Sant'Angelo dei Lombardi state: AV zip: 83054 country: Italy name: Anna Estraneo, PhD role: CONTACT phone: 3396418648 phoneExt: 39 email: aestraneo@dongnocchi.it name: Alfonso Magliacano, PhD role: CONTACT phone: 3387389414 phoneExt: 39 email: amagliacano@dongnocchi.it name: Anna Estraneo, MD role: PRINCIPAL_INVESTIGATOR name: Alfonso Magliacano, PhD role: SUB_INVESTIGATOR name: Giovanni Scarano, BS role: SUB_INVESTIGATOR lat: 40.92937 lon: 15.17535 facility: Unità Gravi Cerebrolesioni - Dipartimento Neuroscienze - Azienda Ospedaliera - Universitaria Ferrara city: Ferrara zip: 44124 country: Italy name: Susanna Lavezzi role: CONTACT email: s.lavezzi@ospfe.it name: Susanna Lavezzi role: PRINCIPAL_INVESTIGATOR name: Valentina Bonsangue role: SUB_INVESTIGATOR name: Sofia Straudi role: SUB_INVESTIGATOR lat: 44.83804 lon: 11.62057 facility: IRCCS Fondazione Don Gnocchi ONLUS city: Florence zip: 50143 country: Italy name: Bahia Hakiki, PhD role: CONTACT email: bhakiki@dongnocchi.it name: Bahia Hakiki, PhD role: PRINCIPAL_INVESTIGATOR name: Andrea Mannini, PhD role: SUB_INVESTIGATOR name: Piergiuseppe Liuzzi, PhD role: SUB_INVESTIGATOR lat: 43.77925 lon: 11.24626 facility: IRCCS Santa Maria Nascente Fondazione Don Gnocchi ONLUS city: Milan zip: 20148 country: Italy name: Angela Comanducci, PhD role: CONTACT email: acomanducci@dongnocchi.it name: Angela Comanducci, PhD role: PRINCIPAL_INVESTIGATOR name: Tiziana Atzori role: SUB_INVESTIGATOR name: Chiara-Camilla Derchi role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: Instituto de Rehabilitación Neurológica IRENEA city: Valencia zip: 46007 country: Spain name: Enrique Noé, MD role: CONTACT email: enoe@comv.es name: Enrique Noé, MD role: PRINCIPAL_INVESTIGATOR name: Roberto Llorens, PhD role: SUB_INVESTIGATOR name: Alejandro Galvao, PhD role: SUB_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False
<\|newrecord\|> nctId: NCT06323018 id: 384T-26 briefTitle: Effects of Remote Ischaemic Preconditioning in Cemented Hip Arthroplasty. acronym: PRINCIPAL overallStatus: RECRUITING date: 2024-03-20 date: 2026-03 date: 2027-03 date: 2024-03-21 date: 2024-04-04 name: University of Tartu class: OTHER briefSummary: Total joint arthroplasty is one of the best treatment options for end-stage osteoarthritis. Cemented hip arthroplasty is mainly indicated for elderly patients with poor bone quality and multiple comorbidities. Bone cement implantation syndrome is associated with cemented hip arthroplasty and it has been shown to increase cardiovascular and renal complication and brain damage postoperatively. The aim of this project is to elucidate whether remote-ischemic preconditioning (RIPC) has multi-organ protective effect in cemented hip arthroplasty patients. conditions: Osteoarthritis, Hip conditions: Cardiovascular Diseases conditions: Bone Cement Implantation Syndrome conditions: Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Randomization and intervention is done by a dedicated study nurse. Patient, orthopedic surgeon, investigator and outcomes assessor and statistician are all blinded to the study intervention. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Remote Ischemic Preconditioning name: SHAM measure: Myocardial injury measure: Cardiovascular injury measure: Clinical serious complications measure: Carotid-femoral pulse velocity measure: Augmentation index measure: Brain injury measure: Kidney Injury measure: Total antioxidative capacity (TAC) measure: Oxidative stress level (total peroxide levels) measure: Inflammation level measure: Low molecular weight metabolites (uM) sex: ALL minimumAge: 65 Years maximumAge: 90 Years stdAges: OLDER_ADULT facility: University of Tartu status: RECRUITING city: Tartu state: Tartumaa zip: 50406 country: Estonia name: Kaspar Tootsi, MD, PhD role: CONTACT phone: +3727318282 email: kaspar.tootsi@kliinikum.ee lat: 58.38062 lon: 26.72509 hasResults: False
<\|newrecord\|> nctId: NCT06323005 id: 2024-0024 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-03-21 date: 2024-04-18 name: [Redacted] hasResults: False
<\|newrecord\|> nctId: NCT06322992 id: R41CA271962 type: NIH link: https://reporter.nih.gov/quickSearch/R41CA271962 briefTitle: App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic Toxicity in Cancer Patients - Aim 3 overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-05 date: 2025-05 date: 2024-03-21 date: 2024-03-22 name: Daynamica, Inc. class: INDUSTRY name: Masonic Cancer Center, University of Minnesota briefSummary: The goal of this observational study is to develop a mobile app for cancer patients undergoing treatments. In Aim 3, patients will rate the quality of the app using the Mobile App Rating Scale (MARS) and their satisfaction with the three key app features. The outcome of this project will be a final prototype app with 70% of patients indicating an overall MARS score of 4.0 or more and satisfaction with the three features. conditions: Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: APP satisfaction measure: APP rating sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06322979 id: # R-PED-11-23-3074 briefTitle: Premixed Bioceramic Putty as an Apical Plug in Immature Anterior Permanent Teeth overallStatus: RECRUITING date: 2023-11-22 date: 2024-11 date: 2024-12 date: 2024-03-21 date: 2024-03-21 name: Tanta University class: OTHER briefSummary: Following the randomization procedure, children will be divided into 2 groups (25 immature anterior permanent incisors in each group): Group I will be treated with MTA as apical plug while group II will be treated with Premixed Bioceramic Putty as apical plug. After working length determination, instrumentation, and irrigation of the root canals, apical plug will be done. in MTA Group, MTA will be placed into the apical 4 mm of root canals, then a moist cotton pellet will be placed and the access cavity will be restored with glass-ionomer-based restoration. Next day, glass-ionomer-based restoration and the cotton pellet will be removed, then the coronal restoration will be completed with GIC, composite. In the Premixed Bioceramic Putty group, Well-Root™ PT will be placed into the apical 4 mm of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite.
children will be recalled for clinical and radiographical follow-up after 6 and12 months after treatment. conditions: Periapical Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Mineral trioxide aggregate name: Premixed Bioceramic Putty measure: the clinical success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA) measure: the radiographic success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA) measure: Change in the periapical index (PAI) sex: ALL minimumAge: 8 Years maximumAge: 11 Years stdAges: CHILD facility: Tanta University status: RECRUITING city: Tanta state: Gharbia zip: 6624033 country: Egypt name: Shaimaa eldesouky, PhD role: CONTACT phone: 01008994242 email: shiamaaeldesouky@dent.tanta.edu.eg name: mohamed ghaly, PhD role: CONTACT phone: 01098472899 lat: 30.78847 lon: 31.00192 hasResults: False
<\|newrecord\|> nctId: NCT06322966 id: STUDY00017745 id: K99ES034442 type: NIH link: https://reporter.nih.gov/quickSearch/K99ES034442 briefTitle: Learning and Living With Wildfire Smoke overallStatus: RECRUITING date: 2023-09-04 date: 2027-05-28 date: 2028-05-26 date: 2024-03-21 date: 2024-03-21 name: University of Washington class: OTHER name: National Institute of Environmental Health Sciences (NIEHS) briefSummary: The proposed intervention in this Youth Participatory Action Research (YPAR) proposal will improve knowledge and awareness of the health impacts of air pollution exposure, will elevate the youth voice, improve youth self-efficacy and lead to behavior changes that would reduce exposure to air pollution in a high school setting. These outcomes will be accomplished through the introduction of a new air quality curriculum, called AirActions, into freshman science classes, and the establishment of an after-school air quality monitoring program.

Subsets and Splits

No community queries yet

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