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<|newrecord|> nctId: NCT06375837 id: bioactive-NCCLs briefTitle: Comparative Evaluation of an Alkasite-based Restorative Material and Two Different Resin Composites overallStatus: RECRUITING date: 2024-04-15 date: 2024-06-15 date: 2026-06-15 date: 2024-04-19 date: 2024-04-19 name: Hacettepe University class: OTHER briefSummary: The clinical performance of an an alkasite-based restorative material and two different resin composites will be evaluated and compared in non-carious cervical lesions. After recruiting participants with at least three non-carious cervical lesions, all restorations will be placed by a single clinician. Lesions will be divided in three groups: an alkasite-based restorative material (Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)), hybrid resin composite (Gradia Direct Anterior, GC, Tokyo, Japan (GD)) and a highly filled flowable resin composite ((G-aenial Universal Flo, GC, Tokyo, Japan (GF)). All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using FDI criteria. Descriptive statistics will be performed using chi-square tests. conditions: Tooth Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 33 type: ESTIMATED name: an alkasite-based restorative material name: hybrid resin composite name: a highly filled flowable resin composite measure: Clinical performances of different restorative systems according to FDI criteria (Esthetic properties) measure: Clinical performances of different restorative systems according to FDI criteria (Functional properties) measure: Clinical performances of different restorative systems according to FDI criteria (Biological properties) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hacettepe University status: RECRUITING city: Ankara country: Turkey name: Fatma Oz role: CONTACT lat: 39.91987 lon: 32.85427 hasResults: False |
<|newrecord|> nctId: NCT06375824 id: TCM for Pre-COPD briefTitle: Bufei Recipe Reduces the Incidence Rate of COPD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-30 date: 2027-10-31 date: 2024-04-19 date: 2024-04-19 name: Henan University of Traditional Chinese Medicine class: OTHER name: West China Hospital name: The First Affiliated Hospital of Zhejiang Chinese Medical University briefSummary: Establish early TCM prevention and treatment program to reduce the incidence rate of COPD. conditions: Preserved Ratio Impaired Spirometry studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 1100 type: ESTIMATED name: Bufei Recipe name: Bufei Recipe placebo measure: Incidence rate of COPD measure: FVC measure: FEV1 measure: FEV1% pred measure: FEV1/FVC measure: IPAG-Q measure: LFQ measure: COPD-PS measure: CAT measure: SF-36 measure: Clinical symptoms measure: Biochemical indicators sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375811 id: 2000027121_temp briefTitle: Pre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp acronym: PREGnant overallStatus: RECRUITING date: 2024-03-16 date: 2026-06-30 date: 2026-06-30 date: 2024-04-19 date: 2024-04-23 name: Yale University class: OTHER name: University of Colorado, Denver name: Northwestern University name: University of North Carolina name: Duke University name: Johns Hopkins University briefSummary: A Phase 3 clinical trial of oral GnRH antagonist pre-treatment for women with endometriosis who are undergoing IVF, with a primary outcome of live birth rate. The investigators' central hypothesis is that in infertile woman with endometriosis undergoing in vitro fertilization-embryo transfer (IVF-ET), live birth rates will improve in those pretreated with GnRH antagonist compared to those not pretreated with GnRH antagonist. conditions: Infertility conditions: Endometriosis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Half of the subjects (200, randomized or not randomized) will receive elagolix 200mg twice a day (BID) and the other half of subjects will receive placebo BID or SOC IVF (200, placebo or SOC IVF). Elagolix or placebo will be taken for a minimum of 60 days before IVF cycle start. For convenience of IVF cycle scheduling, participants may receive up to an additional 14 days of intervention (elagolix or placebo) beyond the minimum 60 days of pre-IVF treatment, such that the last dose of study intervention (elagolix or placebo) is received no more than 24 hours before start of IVF treatment protocol. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: For participants who agree to be randomized, a computer-generated randomization list will be created by the PREGnant Data Coordinating Center (DCC) and randomization will be performed prior to the first dose of elagolix. Randomization will have random sizes (2, 4, or 6) of blocks and be stratified by site, i.e. whole blocks are assigned to sites. The randomization list will not be available to any person involved in the conduct and evaluation of the trial until the trial is complete and database is declared clean and is released by the DCC. Likewise, treatment allocation information will not be accessible to investigators (except for serious safety concerns), trial staff at the site or central laboratory personnel during the trial. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 288 type: ESTIMATED name: Elagolix 200 MG name: Placebo or SOC IVF measure: Live birth rate measure: Fertilization rate measure: Number of embryos transferred measure: Implantation rate measure: Biochemical pregnancy rate measure: Clinical pregnancy rate measure: Miscarriage rate measure: Overall pregnancy complication rate measure: Gestation age at delivery measure: Infant birth weight sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Colorado Department of Obstetrics & Gynecology status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Katherine Kuhn role: CONTACT phone: 303-724-5276 email: [email protected] name: Nanette Santoro role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 facility: Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences status: RECRUITING city: New Haven state: Connecticut zip: 06520 country: United States name: Michele Frank role: CONTACT phone: 203-785-6949 email: [email protected] name: Hugn Taylor role: PRINCIPAL_INVESTIGATOR lat: 41.30815 lon: -72.92816 facility: Northwestern University Department of Obstetrics and Gynecology status: RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Jessica Almgren-Bell role: CONTACT phone: 312-503-4118 email: [email protected] name: Emily Jungheim role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Johns Hopkins, Division of Reproductive Science and Women's Health Research status: RECRUITING city: Baltimore state: Maryland zip: 21205 country: United States name: Gaelle Massoud, role: CONTACT phone: 410-583-2763 email: [email protected] name: James Segars role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 facility: Duke Fertility status: RECRUITING city: Morrisville state: North Carolina zip: 27560 country: United States name: Tifani Panek role: CONTACT phone: 773-706-4202 email: [email protected] name: Steven Young role: PRINCIPAL_INVESTIGATOR lat: 35.82348 lon: -78.82556 hasResults: False |
<|newrecord|> nctId: NCT06375798 id: 2020137 briefTitle: Clinical Study of Breast Conserving Surgery Combined With Intraoperative Radiotherapy for Early Breast Cancer overallStatus: RECRUITING date: 2020-11-19 date: 2026-11-19 date: 2026-11-19 date: 2024-04-19 date: 2024-04-19 name: Hebei Medical University Fourth Hospital class: OTHER briefSummary: A Single-center, open, prospective study，for analyzing the local recurrence rate, the incidence of incision complications and the aesthetic effect of intraoperative radiotherapy in early breast cancer patients after breast-conserving surgery. conditions: Breast Cancer conditions: HER2-negative Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 620 type: ESTIMATED name: radiotherapy measure: LRFS sex: FEMALE minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Fourth Hospital of Hebei Medical University status: RECRUITING city: Shijiazhuang state: Hebei country: China name: qimei wang, attending role: CONTACT phone: 18633051639 email: [email protected] lat: 38.04139 lon: 114.47861 hasResults: False |
<|newrecord|> nctId: NCT06375785 id: LSVT-BIG vs Otago briefTitle: Two Different Exercise Methods in Geriatrics overallStatus: COMPLETED date: 2023-03-01 date: 2023-06-01 date: 2024-03-01 date: 2024-04-19 date: 2024-04-23 name: Halic University class: OTHER name: Fenerbahce University name: Istanbul Galata University name: Biruni University briefSummary: The aim of the study is to compare slow rhythmic exercises with large amplitude exercises in elderly people conditions: Elderly People conditions: Nursing Homes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 70 type: ACTUAL name: Otago-based (slow rhythmic) exercise group name: LSVT BIG-based (large amplitude) exercise group measure: Timed Up &Go Test measure: Performanz Balance System measure: Functional Reaching Test measure: Six Minute Walking Test measure: Tinetti Balance and Gait Assessment measure: Activity-Specific Balance and Confidence Scale measure: Five Times Sit to Stand measure: Montreal Cognitive Assessment Test measure: KATZ Activities of Daily Living Scale measure: Clinical Frailty Scale sex: ALL minimumAge: 65 Years maximumAge: 80 Years stdAges: OLDER_ADULT facility: Haliç University city: Istanbul state: Eyüpsultan country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06375772 id: 2-DG-02 briefTitle: A Controlled Human Rhinovirus Infection Study of 2-Deoxy-D-Glucose in Healthy Adults overallStatus: RECRUITING date: 2024-04-02 date: 2024-08-31 date: 2024-12-31 date: 2024-04-19 date: 2024-04-19 name: G.ST Antivirals GmbH class: INDUSTRY briefSummary: 2-DG-02 is a randomized, placebo-controlled, double-blind Phase 2 study to investigate the efficacy and safety of 2-Deoxy-D-Glucose as a pre-exposure prophylaxis using the rhinovirus challenge model in healthy study participants. conditions: Acute Nasopharyngitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 128 type: ESTIMATED name: 2-Deoxy-D-glucose name: Placebo measure: The difference in the rate of rhinovirus-associated illness between 2-DG and placebo measure: Number of infected subjects measure: Difference in percent of infected subjects measure: Difference in percent of days virus positive measure: Difference in peak nasal virus load measure: Difference in AUC nasal virus load measure: Difference in Total Jackson Symptom Score measure: Duration of illness measure: Difference in percent of days Jackson Symptom Score positive measure: Difference in Peak Jackson Symptom Score measure: Difference in peak total WURSS-21 measure: Difference in AUC total WURSS-21 measure: Occurrence of adverse events (AEs) and adverse drug-reactions (ADRs) measure: Biodistribution of multiple doses of 2-DG in plasma samples measure: Biodistribution of multiple doses of 2-DG in nasal wash samples sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Centre for Human Drug Research status: RECRUITING city: Leiden zip: 2333 country: Netherlands name: Ingrid de Visser- Kamerling, PhD role: CONTACT phone: +31 71 5246400 email: [email protected] lat: 52.15833 lon: 4.49306 hasResults: False |
<|newrecord|> nctId: NCT06375759 id: XWSSB briefTitle: Subarachnoid-Subarachnoid (S-S) Bypass Versus Adhesion Lysis in Spinal Arachnoiditis and Syringomyelia overallStatus: RECRUITING date: 2024-04 date: 2025-04 date: 2027-04 date: 2024-04-19 date: 2024-04-19 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: To determine whether Subarachnoid-Subarachnoid (S-S) Bypass results in better patient outcomes with fewer complications and improved quality of life compared to intradural adhesion lysis in individuals with Spinal Arachnoiditis and Syringomyelia. conditions: Syringomyelia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Subarachnoid-Subarachnoid (S-S) Bypass name: Intradural Adhesion Lysis measure: complication measure: improvement or resolution of the syrinx, measure: ASIA score measure: Klekamp and Sammi syringomyelia scale measure: modified Japanese Orthopaedic Association Scores (mJOA) measure: xuanwu syringomyelia scale sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fengzeng Jian status: RECRUITING city: Beijing state: Beijing zip: 100053 country: China name: Yuan Chenghua role: CONTACT email: [email protected] name: Jian Fengzeng role: CONTACT email: [email protected] name: jian guan, dr role: SUB_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06375746 id: 0091-22-WOMC briefTitle: The Impact of a Customized Informative Video Prior to Induction of Labor on Anxiety Relieve - a Randomized Controlled Trial overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-01 date: 2024-08-31 date: 2024-04-19 date: 2024-04-19 name: Wolfson Medical Center class: OTHER_GOV briefSummary: To determine whether watching a personalized video prior to medically indicated labor induction among term parturients reduces anxiety levels according to the STAI questionnaire, compared to a standard counselling. conditions: Induction of Labor Affected Fetus / Newborn studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 180 type: ESTIMATED name: Personalized video measure: STAI questionnaire score measure: satisfaction questionnaire sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06375733 id: GFH009X1202 briefTitle: A Study of GFH009 in Combination With Zanubrutinib in Subjects With Relapsed or Refractory DLBCL overallStatus: RECRUITING date: 2024-03-20 date: 2026-12-31 date: 2026-12-31 date: 2024-04-19 date: 2024-04-19 name: Zhejiang Genfleet Therapeutics Co., Ltd. class: INDUSTRY briefSummary: This is a multicentre, open-label phase Ib/II study. The purpose of the study is to assess the safety and efficacy of GFH009 in combination with Zanubrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) conditions: Large B-cell Lymphoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 51 type: ESTIMATED name: GFH009 name: Zanubrutinib name: GFH009 name: Zanubrutinib measure: Phase Ib: adverse events(AEs) measure: Phase II: ORR sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangxi Medical University Cancer Hospital&Guangxi Cancer Institute status: RECRUITING city: Nanning country: China name: Cen Hong role: CONTACT lat: 22.81667 lon: 108.31667 facility: Affiliated Cancer Hospital of Zhengzhou University Henan Cancer Hospital status: RECRUITING city: Zhengzhou country: China name: Keshu Zhou role: CONTACT lat: 34.75778 lon: 113.64861 hasResults: False |
<|newrecord|> nctId: NCT06375720 id: FujianUTCM-2 briefTitle: Efficacy of Different Doses of Tai Chi Chuan on Cognitive Function in Persons With Mild Cognitive Impairment overallStatus: NOT_YET_RECRUITING date: 2024-05-05 date: 2025-06-15 date: 2025-12-15 date: 2024-04-19 date: 2024-04-19 name: Lidian Chen class: OTHER name: Peking University Third Hospital briefSummary: To determine the relationship between the effects of different frequencies and duration of Tai Chi Chuan in dose parameters to improve cognitive function in elderly persons with mild cognitive impairment. conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 350 type: ESTIMATED name: Lower frequency, shorter period of Tai Chi Chuan name: Higher frequency, shorter period of Tai Chi Chuan name: Lower frequency, longer period of Tai Chi Chuan name: Higher frequency, longer period of Tai Chi Chuan name: Standard Health Education measure: Montreal Cognitive Assessment measure: Montreal Cognitive Assessment measure: Wechsler Memory Scale measure: Digit Symbol Substitution Test measure: Trial Making Test part B measure: Stroop Color Word Test measure: Boston Naming Test measure: Rey-Osterrieth Complex Graphics Test measure: Rey Auditory Verbal Learning Test measure: The Pittsburgh Sleep Quality Index (PSQI) measure: 12-Item Short Form Health Survey measure: Blood glucose metabolism index measure: Blood lipid metabolism index measure: functional Magnetic Resonance Imaging measure: Electroencephalogram measure: Heart rate variability measure: Gut microflora sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375707 id: HERO-KC23 briefTitle: Efficacy and Safety of Ribociclib in Combination With NSAI Versus Physician's Choice of Chemotherapy Sequential Endocrine Therapy in HR+/HER2- Advanced Breast Cancer overallStatus: RECRUITING date: 2024-01-09 date: 2025-11 date: 2025-12 date: 2024-04-19 date: 2024-04-19 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER name: Zhejiang Cancer Hospital briefSummary: Evaluate the efficacy and safety of Ribociclib in combination with NSAI versus physician's choice of chemotherapy sequential endocrine therapy in HR+/HER2- advanced breast cancer. conditions: Advanced Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 144 type: ESTIMATED name: physician's choice of chemotherapy sequential Ribociclib combined with NSAI±OFS name: Ribociclib combined with NSAI±OFS measure: Progression Free Survival measure: Progression Free Survival2 measure: Time to treatment failure measure: Overall response rate (ORR) measure: Overall survival(OS) measure: Time To Response (TTR) measure: Clinical benefit rate(CBR) measure: Change from baseline in the global health status/QOL scale score by using FACT-B questionnaire measure: Frequency/severity of adverse events, lab abnormalities sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jiangsu Provincial People's Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Wei Li, Ph.D role: CONTACT phone: 025-68306360 email: [email protected] name: Wei Li, Ph.D role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 hasResults: False |
<|newrecord|> nctId: NCT06375694 id: IRB00025485 briefTitle: Probiotic Effect on Dietary Nitrate to Plasma Nitrite Production ( OPEDNPN ) acronym: OPEDNPN overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-05 date: 2025-05 date: 2024-04-19 date: 2024-04-19 name: Wake Forest University class: OTHER name: University of South Florida briefSummary: Nitric Oxide (NO) is an important molecule that is produced naturally in the body and that helps maintain healthy blood flow. Low availability of NO contributes to many diseases while administration of NO is therapeutic. |
In addition to being made naturally in the body, NO can be obtained through the diet via the Nitrate-Nitrite-NO cycle. Nitrate, which is abundant in green leafy vegetables and beetroot juice, is partially converted to nitrite by oral bacteria. The nitrate and nitrite are taken up into the blood and nitrite is converted into NO. Remaining nitrate in the blood is taken back up into the mouth by salivary glands and the cycle continues. Emerging studies suggest that the Nitrate-Nitrite-NO cycle may contribute to cardiovascular health. In addition, there have been many studies where dietary nitrate is given to increase NO and treat various conditions. |
The current study rests on the premise that the quality of the oral microbiome plays a major role in the Nitrate-Nitrite-NO cycle and hence cardiovascular health and the efficacy of dietary nitrate interventions. Investigators have begun to identify oral bacterial species that are effective nitrite producers as well as though that are nitrite depleters (those that interfere with nitrite production from nitrate). |
In laboratory experiments, certain bacterial species have been shown to block nitrate to nitrite conversion by other oral bacteria. These nitrite depleting species are found in a commercially available oral probiotic designed to improve oral health. The purpose of this study is to examine if use of the probiotic negatively affects the Nitrate-Nitrite-NO cycle. Nitrate to Nitrite conversion will be assessed by measuring plasma levels of nitrite before and after consumption of nitrate-rich beetroot juice. Dietary nitrate to plasma nitrite conversion will assessed at baseline and after one week of consumption of the probiotic or a placebo (follow-up). The primary hypothesis of this study is that participants that consume the probiotic will have lower nitrate to nitrite conversion at follow-up compared to baseline and that there will be no significant change in nitrate to nitrite conversion between baseline and follow-up for participants who consume the placebo. |
While this study does not aim to treat any specific disease, it is intended to elucidate a basic physiological function that may be relevant to cardiovascular health and certain NO-based therapeutics. conditions: Hypertension conditions: Cardiovascular Diseases conditions: Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized into two groups with one group receiving the oral probiotic and the other receiving the placebo. Each group will take their intervention 2X a day for 7 days. primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Participants will not know which group they are in. The lozenges will be distributed in unmarked bottles whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: Herbiotics Oral + Ent Probiotic measure: Dietary Nitrate Conversion to Plasma Nitrite measure: Percentage Lactobaciluus sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375681 id: 2019-1378: R01 id: 1R01AG076157-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01AG076157-01 id: A487400 type: OTHER domain: UW Madison briefTitle: Effectiveness of Cognitive Training in Older and Younger Adults overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-01 date: 2028-01 date: 2024-04-19 date: 2024-04-19 name: University of Wisconsin, Madison class: OTHER name: National Institute on Aging (NIA) briefSummary: The proposed study will enroll 1600 participants to examine the effectiveness of cognitive training. Participants will be randomized into different experimental groups and can expect to participate for up to 15 hours of research over 4 to 8 weeks. conditions: Cognitive Change studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Following Pre-testing, participants randomly assigned into the full study will be further randomly assigned to a total of 9 unique experimental conditions for the full 2x2x2+1 factorial design. |
The full description of the study's 9 arms will be registered after data collection is completed to preserve the scientific integrity of the study. primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: All researchers that have contact with participants will be unaware of the tested hypothesis of the study. |
Participants will be unaware of the experimental conditions. |
Researchers and participants will be unaware (blinded) to the game conditions assigned to the participant, except for researchers in charge of supervising the training part of the study who will be aware what training the participant is undergoing. |
More information on how this was achieved will be registered after data collection is completed to preserve the scientific integrity of the study. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 1600 type: ESTIMATED name: Visual and / or Auditory Cognitive Tasks (1) name: Visual and / or Auditory Cognitive Tasks (2) measure: Change in the difference between the proportion of hits minus false alarms for a given level of the N-back task measure: Change in the proportion of correctly reported sequences in the Corsi Complex task measure: Change in the proportion of correctly reported number and letter sets in the Letter-Number task measure: Change in the difference of response time and accuracy in switch trials minus non-switch trials in the Task Switching Task measure: Change in the difference of response time in (i) switch trials minus non-switch trials and (ii) congruent minus incongruent trials in the Flanker Task measure: Change in the proportion of correctly identified targets in the mixed condition of the Cancellation task measure: Change in the proportion of correct responses on the Useful Field of View (UFOV) Task measure: Change in the proportion of correct responses on the Multiple Object Tracking (MOT) Task measure: Change in the response time and percentage of correct responses in the Mental Rotation Task measure: Change in the percentage of correct responses in the Paper Folding task measure: Change in the sum of correctly solved items in Raven's Advanced Progressive Matrices task measure: Change in the sum of correctly solved items in the UC Matrix Reasoning task measure: Change in the percentage of accuracy in the Shipley Institute of Living Scale measure: Change in the percentage of accuracy in the Mill-Hill Vocabulary Scale measure: Big-5-Inventory 10-item version (BFI-10) Score measure: Behavioral Inhibition/Activation System (BIS/BAS) Score measure: Grit and Conscientiousness Score measure: Meta-Cognition Score measure: Theories of Intelligence - Mindset (Fixed vs Growth) Score measure: Schutte self-report emotional intelligence test (SSEIT) Score measure: Work and Family Orientation (WOFO) Score measure: Brief Pittsburgh Sleep Quality Index (B-PSQI) Score measure: Participant Experience Measure 1 measure: Participant Experience Measure 2 measure: Participant Experience Measure 3 measure: Participant Experience Measure 4 measure: Participant Experience Measure 5 sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, Riverside city: Riverside state: California zip: 92521 country: United States name: Aaron Seitz, PhD role: CONTACT phone: 951-827-6422 email: [email protected] lat: 33.95335 lon: -117.39616 facility: Northeastern University city: Boston state: Massachusetts zip: 02115 country: United States name: Susanne Jaeggi, PhD role: CONTACT phone: 617-373-3653 email: [email protected] lat: 42.35843 lon: -71.05977 facility: University of Wisconsin - Madison city: Madison state: Wisconsin zip: 53706 country: United States name: C. Shawn Green, PhD role: CONTACT phone: 608-263-4868 email: [email protected] lat: 43.07305 lon: -89.40123 hasResults: False |
<|newrecord|> nctId: NCT06375668 id: CT/NB/140/2020/PR-MS briefTitle: The Effect of the Probiotic Strains on Bone Mineral Density in Postmenopausal Women overallStatus: ACTIVE_NOT_RECRUITING date: 2022-03-15 date: 2024-01-15 date: 2024-06-15 date: 2024-04-19 date: 2024-04-24 name: Nordic Biotic Sp. z o.o. class: INDUSTRY briefSummary: Osteoporosis is a systemic condition characterized by low bone mass and altered bone tissue microarchitecture, with the resulting greater bone fragility leading to fractures. Osteoporosis develops as a result of genetic and environmental factors, with the patient's lifestyle playing an important role. Recent years saw an emergence of reports on the significance of the intestinal microbiota in the development of osteoporosis, thus new ways of modifying the composition and activity of microbiota have been sought, and the potential role of probiotics has been considered. Probiotics are defined as live microorganisms, which-when administered at appropriate doses-are beneficial to the host's health. Probiotics both modify the gut microbiota composition and directly affect the human body. Recently published clinical studies demonstrated that probiotics may facilitate osteoporosis treatment and prevention. The current randomized double-blind placebo-controlled study will assess the effect of a dietary intervention via oral supplementation of Lactobacillus plantarum and Lactobacillus paracasei in a population of Polish postmenopausal women on their bone mineral density assessed via bone densitometry-derived T-scores of the lumbar segment of the spine (L1-L4). Study subjects will take the provided probiotic formulation/placebo orally once daily for 12 months. conditions: Osteoporosis, Postmenopausal conditions: Bone Density, Low studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 170 type: ACTUAL name: Probiotic name: Placebo measure: The effect of intervention on bone mineral density measure: Changes in the level of calcium measure: Changes in the level of phosphorus measure: Changes in the level of alkaline phosphatase measure: Changes in the level of vitamin D measure: Changes in the level of C-reactive protein measure: Changes in Body Mass Index (BMI) measure: Changes in type of stools measure: Changes in the number of bowel movements measure: Changes in severity of abdominal pain measure: Changes in severity of bloating measure: Occurrence of adverse events measure: Satisfaction with the intervention sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Private Specialist Practice city: Bytom zip: 41-902 country: Poland lat: 50.34802 lon: 18.93282 facility: Specialist Practice city: Katowice zip: 40-750 country: Poland lat: 50.25841 lon: 19.02754 facility: Clinical Research Center city: Poznań zip: 60-773 country: Poland lat: 52.40692 lon: 16.92993 hasResults: False |
<|newrecord|> nctId: NCT06375655 id: STUDY20240085 briefTitle: Texting to Promote Breastfeeding (TOPS) overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2025-07-31 date: 2025-07-31 date: 2024-04-19 date: 2024-04-24 name: Lydia Furman class: OTHER briefSummary: The purpose of the study is to see if a program of text messages that support and promote breastfeeding for expecting and delivered African-American/Black women (called TEAM2BF), as compared to a national maternal health texting program (called Text4baby), can result in more women being able to breastfeed their infant. Because breastfeeding is healthy for mothers and babies, and because fewer African-American/Black women decide to breastfeed and continue breastfeeding than many other racial and ethnic groups, researchers like us are trying to figure out ways to be supportive to African-American/Black mothers who might be interested in breastfeeding. The investigators will enroll up to 80 mothers and their infants at UHCMC. conditions: Increased Breastfeeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 80 type: ESTIMATED name: Team2BF name: Text4baby measure: Percentage of participants who do not opt out of receipt of text messages measure: Percentage of participants who said texts were helpful as measured by questionnaire measure: Percentage of participants who would refer a friend/family to the texting program measure: Percentage of participants who are exclusively breastfeeding at 2 months postpartum as measured by participant report/chart review measure: Percentage of participants who are exclusively breastfeeding as measured by participant report/chart review measure: Percentage of participants who are partially breastfeeding as measured by participant report/chart review sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ahuja Rainbow Center for Women and Children city: Cleveland state: Ohio zip: 44103 country: United States name: Lydia Furman, MD role: CONTACT phone: 216-675-6691 email: [email protected] lat: 41.4995 lon: -81.69541 hasResults: False |
<|newrecord|> nctId: NCT06375642 id: SHR1316-HMPL012-HAIC-01 briefTitle: A Single Arm, Single Centered Phase II Trial on the Combination of Adebrelimab, Surufatinib and Irinotecan Liposome-based HAIC in Advanced iCC overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2025-08-31 date: 2026-08-31 date: 2024-04-19 date: 2024-04-19 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: Southeast Asia and China have the highest incidence of intrahepatic cholangiocarcinoma worldwide, with limited treatment options and large unmet medical needs. |
Hepatic arterial infusion chemotherapy (HAIC) has gradually emerged as a promising treatment option for patients with hepatocellular carcinoma (HCC). Increasing evidence suggests that infusion of HAIC, which maintains high local concentrations of toxic agents in tumors without embolism, provides a significant survival benefit for patients with advanced HCC and is well-tolerated. However, there is limited evidence for the efficacy of HAIC for intrahepatic cholangiocarcinoma. |
Irinotecan liposome (nal-IRI) is a concentrate of an infusion solution containing 5 mg/ml irinotecan trihydrate (irinotecan sucrose salt) active substance, which is encapsulated in liposomes and prevents premature conversion of the drug to SN-38 in the liver. Liposomal irinotecan prolongs the circulation time of the drug in the plasma of patients and prolongs the tumor exposure of the drug compared to conventional irinotecan.Nal-IRI based protocol has shown positive results in the phase III trial of pancreatic carcinoma. |
Adebrelima(SHR-1316) is a recombinant humanized IgG4 antibody that binds efficiently and specifically to human and cynomolgus programmed cell death ligand 1 (PD-L1, CD274, or B7-H1), a cell surface molecule that plays an important role in T cell immune function, and stimulates IFN-γ secretion from mixed lymphocyte reactions (MLRs) of dendritic cells (DCs) and CD4 + T cells. |
Surufatinib is a multiple kinase inhibitor targeting VEGFR 1-3, FGFR1 and CSF1R. |
This study aims to evaluate the efficacy and safety of irinotecan liposome-based hepatic arterial infusion chemotherapy combined with adebrelimab and surufatinib in the treatment of intrahepatic cholangiocarcinoma, which may bring significant clinical benefit to the iCC patients with new treatment options. conditions: Intrahepatic Cholangiocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Adebrelimab measure: Objective Response Rate measure: Disease Control Rate measure: Overall Survival measure: Progress-Free Survival measure: Incidence and severity of AE and SAE measure: Dose suspension rate caused by adverse events measure: dose termination rate caused by adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Cancer Hospital Airport Hospital city: Tianjin state: Tianjin zip: 300308 country: China lat: 39.14222 lon: 117.17667 hasResults: False |
<|newrecord|> nctId: NCT06375629 id: EDAP TMS briefTitle: ES-HIFU, Prospective Data Collection of Patients Treated With Partial Gland HIFU Ablation for Prostate Cancer acronym: ES-HIFU overallStatus: RECRUITING date: 2023-04-20 date: 2027-04-20 date: 2027-04-20 date: 2024-04-19 date: 2024-04-19 name: EDAP TMS S.A. class: INDUSTRY briefSummary: The objective of this study is to evaluate the clinical effectiveness and safety of treatment of prostate cancer in patients who have received a focal HIFU treatment using the Focal One medical device. conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: FocalOne measure: Evaluation of adverse events measure: Evaluation of quality of life measure: Evaluation of urinary incontinence measure: Erectile function assessment measure: Urinary Symptoms sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Puerta del Mar status: RECRUITING city: Cadiz zip: 21 11009 country: Spain name: Cristina Salvatierra Pérez, Doctor role: CONTACT phone: +34 956 00 21 00 email: [email protected] lat: 36.52672 lon: -6.2891 facility: Hospital General Universitario Gregorio Marañón C/ Doctor Esquerdo status: RECRUITING city: Madrid zip: 46 28007 country: Spain name: Carlos Hernández Fernández, Doctor role: CONTACT phone: +34 912 05 38 54 email: [email protected] lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Central De Asturias status: RECRUITING city: Oviedo zip: 33011 country: Spain name: Jorge Garcia Rodriguez, Doctor role: CONTACT phone: +34 985 10 80 00 email: [email protected] lat: 43.36029 lon: -5.84476 facility: Hospital Universitario Marqués De Valdecilla status: RECRUITING city: Santander zip: 39008 country: Spain name: Mario Dominguez Esteban role: CONTACT phone: +34 942 42 06 26 email: [email protected] lat: 43.46472 lon: -3.80444 facility: Hospital Consorcio General Universitario de Valencia status: RECRUITING city: Valencia zip: 46014 country: Spain name: Emilio Mr López Alcina, Doctor role: CONTACT phone: +34 960 64 00 78 email: [email protected] lat: 39.46975 lon: -0.37739 hasResults: False |
<|newrecord|> nctId: NCT06375616 id: KY2024-023 briefTitle: Comparison of Nafamostat and Unfractionated Heparin in RRT for Sepsis Associated AKI overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-04-19 date: 2024-04-19 name: Shen Lei class: OTHER briefSummary: The goal of this clinical trial is to compare the safety and efficacy of nafamostat mesylate (NM) and unfractionated heparin (UFH) in the process of renal replacement therapy (RRT) for patients suffering from sepsis associated acute kidney injury (SA-AKI). The main questions it aims to answer are: |
The impact of NM and UFH on platelet count in septic patients undergoing RRT treatment. |
The satisfaction with anticoagulation of NM and UFH in septic patients undergoing RRT treatment. |
The 28-day all-cause mortality rate of septic patients undergoing RRT treatment with NM and UFH. |
Researchers will use NM or UFH as anticoagulation during RRT in SA-AKI patients, assessing effects on platelet count, anticoagulation satisfaction, and mortality. |
Participants will receive NM or UFH as anticoagulation during RRT for a minimum of 7 days. Bleeding symptoms, platelet count and coagulation function will be monitored daily. Platelet changes during the 7-day treatment period and survival status at 28 days post-treatment will be recorded. conditions: Sepsis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 156 type: ESTIMATED name: Nafamostat Mesylate name: Unfractionated Heparin measure: Platelet decline rate measure: Satisfaction of filter anticoagulation measure: All-cause mortality at 28 days sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huashan Hospital, Fudan University city: Shanghai state: Shanghai country: China name: Lei Shen, MD role: CONTACT phone: 86-021-52887920 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06375603 id: SMARTALPHA-NERVEBLOX-1001 briefTitle: Nerve and Plane Block Data Collection Study for the Development of Artificial Intelligence-assisted Software overallStatus: COMPLETED date: 2022-12-01 date: 2023-05-01 date: 2023-05-01 date: 2024-04-19 date: 2024-04-19 name: Smart Alfa Teknoloji San. ve Tic. A.S. class: INDUSTRY name: Ankara University briefSummary: The primary objective of this observational study is to acquire ultrasound images (raw data) from nerve and plane block regions to develop artificial intelligence-guided nerve block software (Nerveblox). The study aims to acquire raw ultrasound video from 200 volunteers' planned nerve and plane block regions. These participants will undergo ultrasound scans administered by expert clinicians proficient in these techniques in their clinical practice. The data collection devices utilized in this study are FDA-cleared general-purpose ultrasound devices. conditions: Ultrasound Imaging of Anatomical Structures conditions: Nerve Block studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ACTUAL name: Ultrasound scans measure: Assessment of image quality sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara University School of Medicine city: Ankara zip: 06230 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False |
<|newrecord|> nctId: NCT06375590 id: 2024-NavIIcusp briefTitle: NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2026-05-01 date: 2024-04-19 date: 2024-04-19 name: Didier TCHETCHE class: OTHER name: Abbott briefSummary: The aim of this prospective registry is to evaluate the clinical impact of the new Navitor prosthesis (Abbott, Minneapolis, MN, USA) in BAV and evaluate both the main sizing methods (the classical annular or the supra-annular with ICD measurement at 4 mm above the virtual basal ring). conditions: Bicuspid Aortic Valve studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Transcatheter Aortic Valve Implantation measure: 30-day device success (Rate) measure: 1 year at least moderate bioprosthetic valve deterioration measure: 1 year severe patient-prosthesis mismatch measure: 30 days and 1 year all-cause and cardiovascular mortality measure: 30 days and 1 year stroke sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique Pasteur city: Toulouse state: Occitanie zip: 31076 country: France name: Didier Tchétché, MD role: CONTACT name: Didier Tchétché role: PRINCIPAL_INVESTIGATOR name: Chiara De Biase, MD, PhD role: SUB_INVESTIGATOR lat: 43.60426 lon: 1.44367 hasResults: False |
<|newrecord|> nctId: NCT06375577 id: LMS-24-Dean-1 briefTitle: Speed of Absorption overallStatus: RECRUITING date: 2024-06 date: 2025-04 date: 2025-04 date: 2024-04-19 date: 2024-04-22 name: Lancaster University class: OTHER briefSummary: The purpose of this study is to look at how fast commercially available supplements containing carbohydrate can get into the bloodstream. If carbohydrate, in the form of glucose, gets into the blood faster, this can provide an instant energy source and help fuel the body during exercise. We will be testing three supplements, namely Voom Pocket Rocket, SIS Go Isotonic Energy Gel, and Maurten Gel 160. Each participant will complete all three conditions, consuming one of each supplement at random per condition. The study requires participation from male runners, cyclists and triathletes who are aged between 18-35. |
Each visit will take approximately 1 hour and 30 minutes, and three experimental visits per participant. The study will involve frequent blood sampling and the continuous monitoring of gas exchange (oxygen/carbon dioxide). Blood sampling via cannulation will be used to analyse the lactate, glucose, and insulin content of the blood. Gas exchange will measure the oxygen breathed in and carbon dioxide breathed out throughout the study. |
The investigators plan to carry out the study on 16 participants who will be a mix of male runners, cyclists and triathletes. conditions: Healthy conditions: Nutrition, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This will be a double-blind randomised crossover design. There will be 1 group of participants who will complete all three conditions at random: |
Condition 1 - consume Voom Pocket Rocket. Condition 2 - consume SIS Isotonic Energy Gel. Condition 3 - consume Maurten Gel 160. |
All participants will undergo the same measures - blood sampling for blood glucose, blood lactate, and insulin, and monitoring of gas exchange during each study visit. primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: Both the participants and investigators will be blinded to what supplement they are consuming on each visit. Each supplement will taste the same, and be placed into identical packaging, and be randomly labelled (e.g., A, B, C). This will be done to avoid potential bias. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 16 type: ESTIMATED name: 45 grams Voom Pocket Rocket Electro Energy name: 45 grams SIS Go Isotonic Energy Gel name: 45 grams Maurten Gel 160 measure: Blood Glucose measure: Blood Lactate measure: Insulin measure: Gas Exchange sex: MALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Lancaster University status: RECRUITING city: Lancaster state: Lancashire zip: LA1 4AT country: United Kingdom lat: 54.04649 lon: -2.79988 hasResults: False |
<|newrecord|> nctId: NCT06375564 id: XMYY-2020KY067-05 briefTitle: Clinical Evaluation of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression overallStatus: RECRUITING date: 2024-05-01 date: 2025-12-30 date: 2026-12-30 date: 2024-04-19 date: 2024-04-23 name: The First Affiliated Hospital of Xiamen University class: OTHER briefSummary: This is an open-label, non-controlled, non-randomized study to assess the therapeutic efficacy of 177Lu-AB-3PRGD2 in patients with various solid tumors who will undergo radioligand therapy using 177Lu-AB-3PRGD. conditions: Refractory Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: 177Lu-AB-3PRGD2 radioligand therapy measure: Objective response rate (ORR) measure: Incidence of treatment-related adverse events (safety and tolerability) sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Xiamen University status: RECRUITING city: Xiamen state: Fujian zip: 361003 country: China name: Haojun Chen role: CONTACT phone: +8618659285282 email: [email protected] name: Hao Fu, MD, PhD role: CONTACT phone: +8615959230059 email: [email protected] name: Haojun Chen, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Hao Fu, MD, PhD role: SUB_INVESTIGATOR lat: 24.47979 lon: 118.08187 hasResults: False |
<|newrecord|> nctId: NCT06375551 id: 1171-0623 id: K01MH128761 type: NIH link: https://reporter.nih.gov/quickSearch/K01MH128761 briefTitle: K-ORCA: Testing a Decision Support Tool and Group Process for Selecting Interventions acronym: K-ORCA overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2027-07-31 date: 2027-07-31 date: 2024-04-19 date: 2024-04-19 name: Chestnut Health Systems class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: This proposal responds to NIMH Objective 4.2.c to develop "decision-support tools and technologies that increase the effectiveness and continuous improvement of mental health interventions" by leveraging the Family First Prevention Services Act (FFPSA) policy opportunity. First, a web-based platform to host (a) a decision-support tool and (b) automated facilitation for group decisions with the tool will be developed with state partners' feedback. Next, decision makers leading their states' FFPSA quality improvement efforts will be engaged to pilot a decision-support intervention comprised of the tool and live or automated facilitation, and to evaluate the implementation quality of evidence-based programs adopted with the decision-support intervention. conditions: Child Abuse conditions: Decision Making conditions: Child Welfare conditions: Decision Making, Shared conditions: Decision Support Technique conditions: Social Facilitation conditions: Implementation Science conditions: Policy conditions: Organizations conditions: Consensus conditions: Mental Health conditions: Family studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 80 type: ESTIMATED name: Optimizing Responses with Collaborative Assessments-Automated (ORCA-A) name: Optimizing Responses with Collaborative Assessments-Live (ORCA-L) measure: Mean changes in decision assumptions, decision goals Pre and Immediately Post-intervention measure: Mean changes in decision experience quality pre-post intervention measure: Mean changes in decision commitment pre-post intervention measure: Mean changes in perceived potential community health impact pre-post intervention measure: Descriptive changes in ordinal intervention rankings assisted (with ORCA) compared to unassisted (no ORCA) measure: Qualitatively described rationale for program adoption from pre-post intervention measure: Descriptive, mean group-level changes in perceived feasibility of intervention Pre-post intervention measure: Descriptive, mean group-level changes in perceived acceptability of intervention for implementation measure: Descriptive, mean group-level changes in perceived appropriateness of intervention for implementation measure: Descriptive differences in implementation process fidelity (activities completed) for interventions adopted with ORCA measure: Descriptive differences in implementation process fidelity (timing) for interventions adopted with ORCA measure: Qualitative changes in decision reasoning pre- post-intervention measure: Qualitative changes in decision goals pre- post-intervention measure: Qualitative changes in decision consensus pre- post-intervention measure: Time to adoption or re-adoption of interventions with ORCA sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375538 id: B2022-527 briefTitle: Ultrasound Evaluations of Diaphragm and Intercostal Muscle to Predict the Failure of High-Flow Nasal Cannula Therapy overallStatus: RECRUITING date: 2022-10-21 date: 2025-08-31 date: 2025-12-31 date: 2024-04-19 date: 2024-04-19 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: The study aims to predict the failure of High-flow Nasal Cannula oxygenation therapy by ultrasound evaluation of diaphragm and intercostal muscle contraction during the first 24 hours. conditions: High-flow Nasal Cannula conditions: Ultrasound Evaluation conditions: Diaphragm and Intercostal Muscle studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Ultrasound evaluation of diaphragm measure: Ultrasound evaluation of intercostal muscle movement index measure: The patient's condition deteriorated and required noninvasive or intubated invasive mechanical ventilation. measure: ICU stay measure: Hospital stay measure: all cause mortality measure: Oxygen saturation measure: respiratory rate measure: oxygen concentration measure: flow velocity of HFNC measure: VT measure: duration on HFNC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Zhongshan Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Wei Wu role: CONTACT phone: 13817976707 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06375525 id: SHEBA-15-2635-SMC briefTitle: Clinical Trial: The Efficacy of Janssen's Icon Application (App) in Improving Adherence to Treatment With Stimulant Medications in Children With Attention Deficit/Hyperactivity Disorder acronym: App ADHD overallStatus: COMPLETED date: 2015-11 date: 2017-08 date: 2017-08 date: 2024-04-19 date: 2024-04-19 name: Prof. Doron Gothelf MD class: OTHER_GOV briefSummary: The overarching aim of the study is to assess the efficacy of Janssen's icon Application (App), a digital tool designed to improve adherence to medication treatment in children with ADHD. |
Our specific hypotheses are: |
1. In children receiving medication for ADHD those provided with the App tool will be more adherent to treatment than children treated as usual (i.e., not provided with the App tool). |
2. Adherent patients will show greater improvement of ADHD symptoms and related dysfunction. conditions: Children Aged 6-18 Years With the Diagnosis of ADHD studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 39 type: ACTUAL name: Janssen's icon Application (App) measure: Attention Module of the Kiddie-SADS questionniare measure: MINI-KID measure: ADHD-Rating Scale Questionnaire (ADHD-RS) measure: Clinical Global Impression Scale (CGI) measure: the Barkley Side Effects Rating Scale measure: Drug accountability by reviewing the completed medication logs sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: ADHD Medical Clinic, Child and Adolescent Psychiatry Unit, Sheba Medical Center city: Ramat-Gan country: Israel lat: 32.08227 lon: 34.81065 hasResults: False |
<|newrecord|> nctId: NCT06375512 id: IN001001 briefTitle: A Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-12 date: 2026-06 date: 2024-04-19 date: 2024-04-19 name: Shenzhen Shenxin Biotechnology Co., Ltd class: INDUSTRY briefSummary: The study will evaluate the safety, tolerability, and immunogenicity (your immune system's reaction) of the study vaccine called Herpes Zoster IN001 mRNA Vaccine (IN001) in healthy participants who are between 50 and 69 years of age conditions: Herpes Zoster studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: HZ Vaccine (IN001) name: Placebo name: Shingrix measure: Percentage of Participants Reporting Solicited Local Reactions measure: Percentage of Participants Reporting Solicited Systemic Reactions measure: Percentage of Participants With Unsolicited Adverse Events (AEs) measure: Percentage of Participants With Any Medically Attended AEs (MAAEs) measure: Percentage of Participants With Any Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), AEs Leading to Vaccine Discontinuation, and AEs Leading to Study Withdrawal measure: Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) measure: Change from Baseline in Geometric Mean Fold Rise (GMFR) of Anti-gE Antibodies as Measured by ELISA measure: Proportion of Participants with Vaccine Response in Anti-gE Antibodies as Measured by ELISA measure: Geometric Mean Titer (GMT) of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay measure: Change from Baseline in GMFR of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay measure: Proportion of Participants with Vaccine Response in Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay measure: gE-specific T Cell Response (IFN-γ and IL-4 Secreting T Cells) as Measured by Enzyme-Linked Immunospot (ELISpot) measure: Frequencies of gE-specific CD4+ and CD8+ T Cells Expressing Activation Markers (i.e., IFN-γ, IL-2, TNFα, CD40L) as Measured by Intracellular Cytokine Staining (ICS) sex: ALL minimumAge: 50 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375499 id: LT2769-004 briefTitle: Comparison of the Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome. overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-04-28 date: 2025-04-28 date: 2024-04-19 date: 2024-04-19 name: Laboratoires Thea class: INDUSTRY briefSummary: The objective is to demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of the change from baseline (D1) in total ocular surface staining score assessed on Oxford 0-15 scale, in the study eye at the D36 visit. |
The investigation is defined as a post-market stage. The clinical investigation design is confirmatory. conditions: Dry Eye Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 74 type: ESTIMATED name: T2769 name: Hylo-Forte® measure: To demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of total ocular surface staining (Oxford score). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375486 id: AK112-IIT-TianjinCIH-LHK briefTitle: Ivonescimab Combined With HAIC for the Treatment of Unresectable Hepatocellular Carcinoma（uHCC）. overallStatus: RECRUITING date: 2024-03-14 date: 2025-03-14 date: 2026-06-15 date: 2024-04-19 date: 2024-04-19 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: This study is a single-center, open-label Phase II clinical trial, aiming to enroll approximately 30 unresectable BCLC stage B or C hepatocellular carcinoma (HCC) patients from China. The primary objective is to evaluate the safety and efficacy of AK112 (a dual-specific antibody against PD-1/VEGF) in combination with hepatic arterial infusion chemotherapy (HAIC) for the treatment of unresectable hepatocellular carcinoma. |
All enrolled subjects will receive AK112 (20mg/kg Q3W) combined with HAIC (utilizing the FOLFOX chemotherapy regimen) until the investigator determines no further clinical benefit (based on RECIST v1.1 imaging evaluation and clinical assessment), intolerable toxicity, completion of 24 months of treatment, or meeting other criteria for treatment discontinuation as outlined in the protocol, whichever occurs first. conditions: Hepatocellular Carcinoma Non-resectable conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Ivonescimab（AK112，a PD-1/VEGF bispecific antibody） measure: Overall response rate (ORR) measure: Progress Free Survival （PFS） measure: Overall survival (OS) measure: Adverse Events（AEs） sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Cancer Hospital Airport Hospital status: RECRUITING city: Tianjin state: Tianjin zip: 300308 country: China name: Huikai Li, Doctor role: CONTACT phone: 18622228639 email: [email protected] name: Yang Liu, MD role: CONTACT phone: 17694950696 email: [email protected] lat: 39.14222 lon: 117.17667 hasResults: False |
<|newrecord|> nctId: NCT06375473 id: MA-PC-RWS-011 briefTitle: Treatment of Irinotecan Hydrochloride Liposome Injection II in China: a Real World Study of Pancreatic Cancer Patients acronym: MA-PC-RWS-011 overallStatus: NOT_YET_RECRUITING date: 2024-04-19 date: 2027-04-19 date: 2027-04-19 date: 2024-04-19 date: 2024-04-19 name: Peking Union Medical College Hospital class: OTHER briefSummary: This study is a multi-center observational study.The start time for data collection is May 1, 2024. Patients' baseline and treatment data will be collected under informed concent. The purpose of this case registry study was to evaluate the safety and efficacy of irinotecan hydrochloride liposome injection II based therapy in Chinese patients with pancreatic cancer in the real world by collecting, understanding, and analyzing the etiology, clinical features, treatment pattern, treatment outcomes, and pharmacoeconomics changes in pancreatic cancer patients receiving this regimen. conditions: Pancreatic Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED name: Irinotecan liposome II combination therapy regimen measure: rwTEAE measure: OS measure: PFS measure: ORR measure: TTP measure: DCR sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital city: Beijing state: Beijing zip: 100730 country: China lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06375460 id: STUDY24020141 id: 1R01DK137803-01A1 type: OTHER_GRANT domain: NIDDK briefTitle: Real-time Engagement for Learning to Effectively Control Type 2 Diabetes acronym: REFLECT2D overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2028-06-01 date: 2029-06-30 date: 2024-04-19 date: 2024-04-19 name: University of Pittsburgh class: OTHER name: Dartmouth College name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) name: University of Michigan name: San Diego State University briefSummary: This is a clinical trial that includes a run-in period, a 90 day micro-randomized trial, and a 90-day observational period. The goal of this study is to evaluate whether providing paired real time glycemic and health behavior data in a smartphone app leads to better glycemic control among adolescents and young adults with T2D. Glycemic control will be monitored using Continuous Glucose Monitors (CGM), and health behavior data will be collected via a Fitbit activity tracker and a research app (Healthmine). Participants will be prompted to view and reflect on glycemic trends and health behavior data (Fitbit data, logging of diet and medication adherence) during the 90-day micro-randomized trial period, then observed for ongoing use of the Healthmine app and engagement with CGM in the following 90-day observation period. conditions: Diabetes Mellitus, Type 2 conditions: Lifestyle conditions: Hyperglycemia conditions: Physical Inactivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Subjects will wear a continuous glucose monitor and activity watch for study duration. Subjects will be micro-randomized once daily for 90 days to receive app prompts regarding nutrition or physical activity. primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Focused App Prompt name: No App Prompt measure: Glucose time above 180mg/dL measure: Mean daily glucose measure: Maximum daily glucose measure: Minimum daily glucose measure: Glucose coefficient of variability measure: Mean amplitude of glycemic excursions measure: Hemoglobin A1c measure: Fasting glucose measure: Objective physical activity (step count) measure: Objective physical activity (moderate-vigorous physical activity) measure: Self-reported physical activity measure: Diet quality measure: Capability measure: Healthmine app use measure: Continuous glucose monitor use use measure: Motivation to engage in diabetes self-management measure: Body Mass Index (BMI) measure: Diabetes distress measure: Diabetes family support and conflict sex: ALL minimumAge: 16 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT facility: Children's Hospital of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15224 country: United States lat: 40.44062 lon: -79.99589 hasResults: False |
<|newrecord|> nctId: NCT06375447 id: Insomnia briefTitle: Intelligent Diagnosis and Treatment Model for Insomnia Disorder overallStatus: RECRUITING date: 2022-12-01 date: 2025-10-31 date: 2025-12-31 date: 2024-04-19 date: 2024-04-19 name: Xuanwu Hospital, Beijing class: OTHER name: West China Hospital name: Beijing Tiantan Hospital name: Ningcheng Center Hospital name: Second Affiliated Hospital of Soochow University briefSummary: To establish a multicenter, multi-dimensional cohort on insomnia disorder and to develop an intelligent model for the diagnosis and treatment of insomnia disorder. conditions: Insomnia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 16000 type: ESTIMATED name: Routine clinical treatment measure: The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of Epworth Sleepiness Scale (ESS) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of sleep onset latency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of wake after sleep onset from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of terminal wakefulness from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of sleep efficiency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of total sleep time from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of time in bed from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of Insomnia severity index (ISI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of Short Form 36 (SF-36) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of PHQ-15 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of PDQ-D-5 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of SHAPS total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital, Capital Medical University status: RECRUITING city: Beijing zip: 100053 country: China name: Hongxing Wang, MD & PhD role: CONTACT phone: 01083198650 email: [email protected] lat: 39.9075 lon: 116.39723 facility: Beijing Tiantan Hospital, Capital Medical University status: RECRUITING city: Beijing zip: 100070 country: China name: Yi Zhang, MD & PhD role: CONTACT phone: 15801203052 email: [email protected] lat: 39.9075 lon: 116.39723 facility: The First Bethune Hospital of Jilin University status: NOT_YET_RECRUITING city: Changchun country: China name: Zan Wang, MD & PhD role: CONTACT lat: 43.88 lon: 125.32278 facility: West China Hospital, Sichuan University status: RECRUITING city: Chengdu zip: 610041 country: China name: Lan Zhang, MD & PhD role: CONTACT phone: 18980601706 email: [email protected] lat: 30.66667 lon: 104.06667 facility: The Second Affiliated Hospital of Soochow University status: NOT_YET_RECRUITING city: Suzhou country: China name: Hua Hu, MD & PhD role: CONTACT phone: 051268282030 email: [email protected] lat: 31.30408 lon: 120.59538 hasResults: False |
<|newrecord|> nctId: NCT06375434 id: 20240101-01 briefTitle: Correlation Between Gut Microbiota and Radiosensitivity of Rectal Cancer acronym: GMRSC-LARC overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-08-15 date: 2024-08-31 date: 2024-04-19 date: 2024-04-19 name: Jing-kun Liu class: OTHER briefSummary: The purpose of this process is to clarify the characteristics of gut microbiota changes in patients with locally advanced rectal cancer undergoing preoperative neoadjuvant treatment, and to identify key bacterial species closely related to sensitivity to radiotherapy. This aims to elucidate the mechanism linking gut microbiome dysbiosis with radiotherapy sensitivity, thereby providing new combined treatment strategies to enhance the efficacy of radiotherapy. conditions: Locally Advanced Rectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: No intervention measure: Diameter of tumor measure: Change in Gut Microbiota Composition measure: Change in Plasma metabolites measure: Five-year survival rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375421 id: GR018280 briefTitle: Pilot and Feasibility of MEMI for Chronic Traumatic Brain Injury overallStatus: ENROLLING_BY_INVITATION date: 2024-04-03 date: 2024-12-31 date: 2024-12-31 date: 2024-04-19 date: 2024-04-19 name: Vanderbilt University Medical Center class: OTHER briefSummary: This is a pilot and feasibility study for a mobile phone-delivered intervention for memory, called MEMI (memory ecological momentary intervention), that was designed to support adults with chronic traumatic brain injury with their memory. The goal of the study is to examine the feasibility and acceptability of MEMI and to assess preliminary efficacy as to whether technology-delivered spaced memory retrieval opportunities improve memory in people with and without a history of chronic traumatic brain injury. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The order of conditions and the order of word list presentation will be counterbalanced. The order of condition/word list combination will be pre-determined, and participants will be assigned to the next available combination based on when they join the study (i.e., a counterbalanced within-person crossover design). primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: MEMI (Memory Ecological Momentary Intervention) Spaced Retrieval name: Blocked Retrieval measure: Acceptability measure: Feasibility (Engagement) measure: Free Recall of Word Forms measure: Cued Recall of Word Forms measure: Cued Recall of Word Meanings measure: Number of Spatial Contexts sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Vanderbilt University Medical Center city: Nashville state: Tennessee zip: 37203 country: United States lat: 36.16589 lon: -86.78444 hasResults: False |
<|newrecord|> nctId: NCT06375408 id: KS2022212 briefTitle: Transcranial Alternating Current Stimulation Prevents Delirium in Patients With Subarachnoid Hemorrhage acronym: TACS overallStatus: RECRUITING date: 2024-03-24 date: 2026-02-24 date: 2026-03-24 date: 2024-04-19 date: 2024-04-19 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: The goal of this clinical trial is to learn about using the latest transcranial alternating current stimulation (tACS) to reduce the incidence of delirium in patients with subarachnoid hemorrhage. The main question it aims to answer is: |
• To evaluate the effect of tACS on reducing delirium in patients with subarachnoid hemorrhage. |
Participants will treated with real tACS or sham tACS. Researchers will mainly compare the two groups to see if patients' delirium will reduce by using tACS. conditions: Subarachnoid Hemorrhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: The random number table method was used for randomization, and the envelope method was used for randomization. The random serial number was stored in an airtight envelope, an envelope was opened when a patient was admitted. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 74 type: ESTIMATED name: Real transcranial alternating electrical stimulation name: Sham transcranial alternating electrical stimulation measure: Incidence of delirium measure: Sleep quality score measure: Anxiety score measure: Duration of delirium measure: Cognitive function score sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital Capital Medical University status: RECRUITING city: Beijing state: Beijing zip: 100053 country: China name: Jun Wang role: CONTACT phone: 18612583695 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06375395 id: Memory Updating Tasks briefTitle: Boosting The Intervention Effect of Negative Memory Through tACS Stimulation overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-12-15 date: 2024-12-31 date: 2024-04-19 date: 2024-04-19 name: Xuanwu Hospital, Beijing class: OTHER name: Beijing Normal University briefSummary: The objectives of this study include: 1) investigating the impact of negative memory substitution on an individual's other intellectual memories (i.e., neutral memories) and the underlying neurocognitive mechanisms; 2) investigating the memory enhancement effect resulting from retrieval practice associated with memory substitution intervention along with an examination of the neurocognitive mechanisms responsible for this enhancement. conditions: Seizures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Active tACS Device name: Sham tACS Device measure: Negative memory retention measure: The negative emotional intensity of negative memory measure: The retention of associated neutral memories as assesses by the proportions of responses of correctly choosing picture category of B picture (A-Bneu) in last A-B paired associate memory test measure: The negative emotional intensity of neutral memory sex: ALL minimumAge: 14 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06375382 id: ZYS2024-01 briefTitle: Effects of Acupuncture on Abdominal Pain-related Intestinal Flora in Patients With Crohn's Disease overallStatus: COMPLETED date: 2015-03-01 date: 2023-12-31 date: 2024-03-31 date: 2024-04-19 date: 2024-04-19 name: Shanghai Institute of Acupuncture, Moxibustion and Meridian class: OTHER briefSummary: Crohn's disease is an intestinal inflammatory disease, causing abdominal pain, diarrhea and other symptoms. The intestinal flora disorder is closely related to the occurrence and development of Crohn's disease. Acupuncture can induce remission of Crohn's disease during mild to moderate active period, improve clinical symptoms such as abdominal pain. This study is to screen the intestinal bacteria related to abdominal pain in CD, and explore the effects of acupuncture on the intestinal flora related to abdominal pain in CD patients. conditions: Crohn Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 64 type: ACTUAL name: acupuncture name: Sham acupuncture measure: Abdominal pain remission rate measure: Crohn's disease activity index （CDAI） measure: Hospital anxiety and depression scale (HADS) measure: Inflammatory bowel disease questionnaire (IBDQ) measure: Safety evaluation (number of participants with abnormal routine blood tests) measure: Safety evaluation (number of participants with abnormal Liver function tests) measure: Safety evaluation (number of participants with abnormal Renal function tests) measure: Gut microbiota composition structure and function measure: Correlation between changes in relative abundance of gut microbes and abdominal pain sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Institute of Acupuncture, Moxibustion and Meridian city: Shanghai zip: 200000 country: China lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06375369 id: Pro00127121 briefTitle: Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy acronym: DECIDE-T overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-19 date: 2024-04-23 name: University of Alberta class: OTHER name: Alberta Innovates Health Solutions briefSummary: The DECIDE-T project is developing a standardized clinical pathway specifically for pediatric patients who require tracheostomy with or without long-term ventilation (tracheostomy/LTV). These patients represent a small portion of Alberta's population but account for over 50% of pediatric patients hospitalized for more than 180 days. The pathway will include a hospital-to-home directive that incorporates digital health solutions to provide support to families, caregivers, and healthcare professionals. Digital supports will include a Connect Care pathway, resources for informed decision-making, educational modules, high-fidelity simulations for family and caregiver education, an online parental resource center, and access to peer support within the hospital and community, as well as a post-discharge telehealth program. |
The goal of the DECIDE-T project is to reduce hospital stays and associated costs for children requiring tracheostomy/LTV, as well as to decrease mental distress and burnout experienced by their caregivers and families. conditions: Tracheostomy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 180 type: ESTIMATED name: Digital health pathway for children with medical complexity requiring tracheostomy (DECIDE-T) measure: Hospital length of stay measure: ICU length of stay measure: ICU readmission measure: Mortality measure: Decannulation measure: Duration of tracheostomy measure: Tracheostomy adverse events measure: Hospital cost measure: Hospital readmission measure: Net-monetary benefit of DECIDE-T measure: Caregivers mental stress sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Alberta Children's Hospital city: Calgary state: Alberta country: Canada name: Karen Kam, MD role: CONTACT email: [email protected] name: Karen Kam, MD role: PRINCIPAL_INVESTIGATOR lat: 51.05011 lon: -114.08529 facility: Stollery Children's Hospital city: Edmonton state: Alberta country: Canada name: Michael van Manen, MD role: CONTACT email: [email protected] name: Michael van Manen, MD role: PRINCIPAL_INVESTIGATOR lat: 53.55014 lon: -113.46871 hasResults: False |
<|newrecord|> nctId: NCT06375356 id: 75119 briefTitle: Stronger: Muscle Strengthening for Menopause overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-08 date: 2026-08 date: 2024-04-19 date: 2024-04-19 name: Stanford University class: OTHER briefSummary: Menopause is a period of time with increased risk for muscle and bone loss. Very few people strength train regularly at least 2 times per week, and commonly reported barriers include inadequate time and resources, worries of safety, inadequate knowledge base of what moves to do and how to do them. Menopause-aged women may report unique barriers - or perceived facilitators - to strength training. This pilot study will develop and test the feasibility and acceptability of an at-home, band-based, expert-supported strength training intervention. conditions: Resistance Training studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: Resistance Training measure: number of strength exercises the participant logged over the intervention measure: Liking of the intervention measure: Number of participants completing post 3 month measure / those randomized and consented measure: Change in total seconds a participant can remain in a wall sit measure: Change in number of full body weight squats in 60 seconds sex: FEMALE minimumAge: 35 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University School of Medicine city: Stanford state: California zip: 94305-7240 country: United States lat: 37.42411 lon: -122.16608 hasResults: False |
<|newrecord|> nctId: NCT06375343 id: SOPH240-0923/I briefTitle: Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive® overallStatus: NOT_YET_RECRUITING date: 2024-10-30 date: 2024-10-30 date: 2025-06 date: 2024-04-19 date: 2024-04-19 name: Laboratorios Sophia S.A de C.V. class: INDUSTRY briefSummary: This is a phase I clinical study to evaluating safety and tolerability of PRO-240 ophthalmic solution through the incidence of unexpected adverse events, as well as through changes in Best Corrected Visual Acuity (BCVA), and the incidence of stinging after its administration, compared to Optive®. conditions: Dry Eye Disease conditions: Dry Eye Sensation conditions: Ocular Surface Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase I, controlled, comparative, single-blind, single-center, comparative clinical trial. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: PRO-240 name: Optive® measure: Incidence of unexpected adverse events related to the interventions measure: Changes in the Ocular Comfort Index score measure: Adherence to treatment (adherence) Adherence to treatment (adherence) measure: Changes in Best Corrected Visual Acuity (BCVA) measure: Changes in tear film breakup time measure: Changes in intraocular pressure (IOP) measure: Changes in the integrity of the ocular surface (fluorescein staining) measure: Changes in lissamine green staining of the conjunctival surface sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375330 id: Poli.01 briefTitle: Clinical Efficacy of Polynucleotides TMJ Injections Compared to Physiotherapy. overallStatus: COMPLETED date: 2023-04-18 date: 2024-01-08 date: 2024-04-08 date: 2024-04-19 date: 2024-04-19 name: Sidoti & Tartaglia Srl class: OTHER briefSummary: The main objective of the present study is the evaluation of the clinical efficacy of the intra-articular administration of polynucleotides in association with hyaluronic acid in the improvement of the subjective and objective manifestations of arthrosis of the temporomandibular joint compared to normal clinical management which involves Physiotherapy. conditions: TMJ Disease conditions: TMJ Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: PoliArt measure: Maximum mouth opening measure: Lateral movements improvements measure: Pain assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UOC di Chirurgia Maxillo-Facciale e Odontostomatologia della Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico city: Milan state: MI zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False |
<|newrecord|> nctId: NCT06375317 id: HCC-HAIC-001 briefTitle: HAIC Combined With PD-L1 Plus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma After Immunotherapy Failure overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-04-30 date: 2026-10-30 date: 2024-04-19 date: 2024-04-19 name: Yehua Shen class: OTHER briefSummary: For patients with advanced liver cancer who have progressed after first-line targeted and immunotherapy , there is currently no standard treatment regimen for second-line therapy. this study aims to explore the efficacy and safety of HAIC combined with PD-L1 and Regorafenib in patients with advanced liver cancer who have failed immunotherapy, not only providing new treatment options for second-line therapy of liver cancer, but also laying the foundation for research on the combination of HAIC and PD-L1 inhibitors plus Regorafenib, which has significant scientific research significance and clinical value. conditions: HCC - Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: PD-L1 inhibitor: Adebrelimab Injection；Regorafenib Tablets measure: Objective Response Rate measure: Disease Control Rate (DCR) measure: Progression-Free Survival (PFS) measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
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