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This study compares the effectiveness of Progestin-Primed Ovarian stimulation versus GnRH protocol for ovarian stimulation in IVF treatment. Participants will be randomly assigned in a 1:1 ratio to receive Progestins or GnRH antagonists. conditions: Progestins Primed Ovarian Stimulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 626 type: ESTIMATED name: Dydrogesterone 10 mg name: Cetrorelix 0.25 mg measure: Ongoing pregnancy measure: The incidence of premature LH surge measure: The incidence of premature progesterone elevation measure: Number of oocytes retrieved measure: Number of mature oocytes measure: Number of day 3 embryos measure: Number of day 5 embryos measure: Number of good quality day 3 embryos measure: Number of good quality day 5 embryos measure: Number of frozen embryos measure: Incidence of Ovarian hyperstimulation syndrome measure: Positive ß-hCG test measure: Clinical pregnancy measure: Ectopic pregnancy measure: Early miscarriage <12 weeks measure: Late miscariage 12-< 22 weeks measure: Live birth rate measure: Gestational age at birth measure: Mode of delivery measure: Birth weight measure: Very low birth weight measure: Low birth weight measure: High birth weight measure: Very high birth weight measure: Preterm birth measure: Gestational diabetes mellitus measure: Hypertensive disorders of pregnancy measure: Maternal mortality measure: Major congenital abnormalities measure: NICU admission measure: Reason for NICU admission measure: Neonatal mortality sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: My Duc Hospital status: RECRUITING city: Ho Chi Minh City zip: 70000 country: Vietnam name: Tuong M Ho, MD role: CONTACT phone: +84 90 3633377 email: [email protected] lat: 10.82302 lon: 106.62965 hasResults: False |
<|newrecord|> nctId: NCT06378255 id: PKUSSNCT-23A04 id: PKUSSIRB-202393160 type: OTHER domain: Ethics Committee of PKUSH of Stomatology id: Z221100007422088 type: OTHER_GRANT domain: The SFP for clinical CDTT in capital briefTitle: Clinical Evaluation of Polycation-based New Dental Desensitizer on Dentin Hypersensitivity overallStatus: RECRUITING date: 2024-03-20 date: 2025-06-30 date: 2025-09-01 date: 2024-04-22 date: 2024-04-22 name: Peking University Hospital of Stomatology class: OTHER briefSummary: Evaluate the safety and clinical efficacy of new dental desensitizers in the treatment of dentin sensitivity, including the relief of sensitivity symptoms and the duration of efficacy. conditions: Dentin Sensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Polycation-based new dentinal desensitizer name: GLUMA desensitizer measure: Improvement of dentin sensitivity induced by probe pressure stimulation measure: Improvement of dentin sensitivity induced by air temperature stimulation sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University School and Hospital of Stomatology status: RECRUITING city: Beijing state: Beijing zip: 100081 country: China name: Qianqian Wang role: CONTACT phone: +86-10-62173403 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06378242 id: RC48-C029 briefTitle: To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2 overallStatus: NOT_YET_RECRUITING date: 2024-04-23 date: 2029-03-15 date: 2029-12-31 date: 2024-04-22 date: 2024-04-22 name: RemeGen Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2 conditions: High-risk Non-muscle Invasive Bladder Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Disitamab Vedotin for injection measure: Incidence of dose-limiting toxicity(DLT) (Phase I) measure: Incidence of Adverse event (Phase I) measure: Recommended Phase II Dose(RP2D) measure: Maximum Tolerated Dosage(MTD) measure: Disease-free survival (DFS) rates measure: Duration of response (DOR) measure: Disitamab Vedotin anti-drug antibody (ADA) measure: PK of enfortumab vedotin: Maximum concentration (Cmax) measure: PK of enfortumab vedotin: Trough concentration (Ctrough) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen Memorial Hospital,SunYat-sen University city: Guangzhou state: Guangdong country: China name: Tianxin Lin, Ph.D role: CONTACT lat: 23.11667 lon: 113.25 facility: Hunan Cancer hospital city: Changsha state: Hunan country: China name: Shusuan Jiang, M.D role: CONTACT lat: 28.19874 lon: 112.97087 facility: The first affiliated hospital with nanjing medical universtity city: Nanjing state: Jiangsu country: China name: qiang Lv, M.D role: CONTACT lat: 32.06167 lon: 118.77778 facility: Shandong Cancer hospital & Institute city: Jinan state: Shangdong country: China name: Jiasheng Bian, M.D role: CONTACT name: Yuping Sun role: SUB_INVESTIGATOR lat: 36.66833 lon: 116.99722 facility: The first affiliated hospital withXi'an Jiao Tong Universtity city: Xi'an state: Shanxi country: China name: Lei Li, M.D role: CONTACT lat: 34.25833 lon: 108.92861 hasResults: False |
<|newrecord|> nctId: NCT06378229 id: ONZ-2023-0157 id: 2022-501857-35-00 type: CTIS briefTitle: Psilocybin for Hospitalized Patients With Treatment-resistant Depression acronym: PSIHOS-D overallStatus: RECRUITING date: 2024-04 date: 2026-03 date: 2026-12-31 date: 2024-04-22 date: 2024-04-25 name: University Hospital, Ghent class: OTHER name: Filament Health briefSummary: The purpose of this study is to determine the safety and feasibility of performing psilocybin-assisted psychotherapy in patients hospitalized for treatment-resistant depression. conditions: Treatment Resistant Depression studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open label feasibility study primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Psilocybin measure: Incidence and type of Treatment-Emergent Adverse Events measure: Columbia-Suicide Severity Rating Scale (C-SSRS) measure: Recruitment and retention rates. measure: Qualitative data from the semi-structured interviews with the subjects and their partners. measure: Montgomery Asberg Depression Rating Scale (MADRS) measure: Quick Inventory of Depressive Symptomatology - Self Rated (QIDS-SR) measure: State-Trait Anxiety Inventory (STAI) measure: World Health Organization Quality of Life Inventory-Brief subscale (WHOQOL-BREF) measure: Maudsley 3-item Visual Analogue Scale (M3VAS) measure: Subjective Emotional Health Visual Analogue Scale (SEHVAS) measure: revised Dyadic Adjustment Scale (RDAS) measure: Zarit Burden Interview - Short Form (Zarit-12 Burden Scale) measure: Client Experiencing Scale (EXP) measure: Mystical Experience Questionnaire (MEQ) measure: Working Alliance Inventory - Short Revised (WAI-SR) measure: Semi-structured interviews. measure: EEG: sensor level analysis (power) and source level analysis (functional connectivity through amplitude envelope correlation), both in resting state and during an emotional paradigm. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ghent University Hospital status: RECRUITING city: Gent state: Oost-Vlaanderen zip: 9000 country: Belgium name: Cisse Geleyn, dr. role: CONTACT phone: +3293328742 email: [email protected] name: Gilbert Lemmens, prof. dr. role: PRINCIPAL_INVESTIGATOR lat: 51.05 lon: 3.71667 hasResults: False |
<|newrecord|> nctId: NCT06378216 id: MEDEA 975 briefTitle: Myotonic Dystrophy Type 1 Congenital and Juvenile Form: From Diagnosis to Rehabilitation [MDCJ-NeuBeRe] acronym: MDCJ-NeuBeRe overallStatus: RECRUITING date: 2022-09-15 date: 2024-03-18 date: 2024-12-30 date: 2024-04-22 date: 2024-04-22 name: IRCCS Eugenio Medea class: OTHER briefSummary: The rationale of the study is to collect structured data in the neuropsychological, clinical neuroradiologic and neurorehabilitation fields in children/young people affected by congenital and juvenile myotonic dystrophy. Children affected by the congenital form (CDM1) present important brain alterations present since birth while, on the contrary, patients with the adult form of DM1 often present a degenerative, slowly progressive neurocognitive picture. Promising therapies that aim to correct the molecular mechanism underlying the symptoms of adult forms of DM1 are under development, but their potential role at the level of the nervous system and in particular in forms of CDM1 (which appears to be a distinct disorder of neuronal development) is also to be clarified. |
To this end, a better definition of neurocognitive profiles and their evolution is essential for the purposes of evaluating the effectiveness of experimental therapies. conditions: Myotonic Dystrophy 1 studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 30 type: ESTIMATED name: neurocognitive evaluations measure: Motor function evaluation by Muscular Impairment Rating Scale measure: cognitive evaluation by Wechsler Intelligence scale measure: cognitive evaluation by Raven Matrices measure: cognitive evaluation by Continous Performance Test 3 measure: cognitive evaluation by Trail Making Test A-B measure: cognitive evaluation by Digit Span and CORSI Test measure: cognitive evaluation by Rey Figure test measure: clinical evaluation by Epworth Sleepiness Scale measure: cognitive evaluation by Wisconsin Card Sorting Test measure: cognitive evaluation by Tower of London test measure: cognitive and behavioral evaluation by Minnesota Multiphasic Personality Inventory measure: cognitive and behavioral evaluation by Vineland Adaptive Behavior Scales sex: ALL minimumAge: 1 Year maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Maria Grazia D'Angelo status: RECRUITING city: Bosisio Parini state: Lecco zip: 23842 country: Italy name: Maria Grazia D'Angelo role: CONTACT phone: +39031 877870 email: [email protected] lat: 45.80075 lon: 9.29 hasResults: False |
<|newrecord|> nctId: NCT06378203 id: MEDEA 1013 briefTitle: Rehabilitation in Muscular Dystrophies From the Hospital Facility to the Home: Pilot Project [RIMUDI] acronym: RIMUDI overallStatus: RECRUITING date: 2023-12-15 date: 2024-12-15 date: 2025-04-15 date: 2024-04-22 date: 2024-04-22 name: IRCCS Eugenio Medea class: OTHER briefSummary: Until twenty years ago physical exercise in muscular dystrophies was considered harmful to the muscle cells, inducing an acceleration of cell necrosis. In fact, it is now certain and validated that an active lifestyle and the practice of controlled and regular physical activity are to be considered therapeutic in neuromuscular pathologies with the aim of optimizing muscular and cardio-respiratory function and preventing atrophy In particular, it seems that the optimal care is extensive and can be carried out in a safe and controlled manner even at home. |
It is well documented that exercise has beneficial effects on muscle with increased strength and muscular endurance. conditions: Muscular Dystrophies conditions: Limb Girdle Muscular Dystrophy conditions: Facio-Scapulo-Humeral Dystrophy conditions: Becker Muscular Dystrophy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Each patient will carry out a series of evaluation and training sessions (15 sessions) with a physiotherapist for the drafting of a personalized treatment plan which will subsequently be carried out "independently" at domicile. |
The home therapeutic proposal will include the use of the tele-rehabilitation system with virtual reality Home Kit - Virtual Reality Rehabilitation System (VRRS KHYMEIA) which allows to perform personalized games at home primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: tele-rehabilitation system with virtual reality Home Kit - Virtual Reality Rehabilitation System (VRRS KHYMEIA) measure: 6 minute walk test (6MWT) measure: Motor Function Measure scale (MFM) measure: Performance of Upper Limb (PUL) measure: Time up and go (TUG) measure: Modification of fatigue and quality of life scales from T0 to T6 measure: Short Form 36 (SF36) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Scientific Institute IRCCS Eugenio Medea status: RECRUITING city: Bosisio Parini state: Lecco zip: 23842 country: Italy name: Maria G D'Angelo, MD role: CONTACT phone: 031877111 phoneExt: +39 email: [email protected] lat: 45.80075 lon: 9.29 hasResults: False |
<|newrecord|> nctId: NCT06378190 id: TranspoCART19 briefTitle: Treatment of Relapsed or Refractory B-cell Lymphoma With Chimeric Antigen Receptor (CAR) T-cell Therapy Produced by a New Technology acronym: TranspoCART19 overallStatus: RECRUITING date: 2024-03-11 date: 2027-04 date: 2028-10 date: 2024-04-22 date: 2024-04-22 name: Instituto de Investigación Biomédica de Salamanca class: OTHER name: Spanish Clinical Research Network - SCReN name: Fundación Canaria de Investigación Sanitaria name: Fundación para la Investigación Biomédica del Hospital 12 de Octubre briefSummary: The goal of this clinical trial is to to evaluate the safety and efficacy of TranspoCART19 in patients with relapsed/refractory B-lymphoma. The main questions it aims to answer are: |
Maximum tolerated dose (MTD) Response rates Participants will be treated with the investigational medicinal product and will be followed for 36 months. conditions: Refractory B-Cell Lymphoma conditions: B-cell Lymphoma Recurrent studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Phase I/II, pilot, open, national, prospective, multicentre, non-randomised primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: CAR-T cells therapy measure: Maximum tolerated dose (MTD) measure: Efficiency measure: Procedure-related mortality (PRM) measure: Toxicity assessment measure: Response (overall and complete) measure: Duration of response measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Perceived general well-being measure: Molecular and cell biology exploratory objectives: Response dynamics measure: Molecular and cell biology exploratory objectives: Response dynamics measure: Molecular and cell biology exploratory objectives: Response dynamics measure: Molecular and cell biology exploratory objectives: In vivo survival of TranspoCART19 cells in peripheral blood measure: Molecular and cell biology exploratory objectives: Analysis of molecular markers which are possibly related to the tumor response to TranspoCART19 cells measure: Molecular and cell biology exploratory objectives: Evaluation of serum biomarkers of toxicity induced by TranspoCART19 cells (cytokine release syndrome and neurotoxicity) measure: Molecular and cell biology exploratory objectives: Epigenetic studies on mononuclear bone marrow cells. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institut Català d'Oncologia Hospital status: NOT_YET_RECRUITING city: Hospitalet de Llobregat state: Barcelona country: Spain name: Esperanza López-Franco, PhD role: CONTACT phone: 923291200 phoneExt: 55779 email: [email protected] name: Alberto Musetti role: CONTACT lat: 41.35967 lon: 2.10028 facility: Virgen de la Arrixaca University Hospital status: NOT_YET_RECRUITING city: El Palmar state: Mur country: Spain name: Esperanza López-Franco, PhD role: CONTACT phone: 923291200 phoneExt: 55779 email: [email protected] name: Joaquín Gómez-Espuch role: CONTACT lat: 37.93939 lon: -1.16095 facility: Clínica Universidad de Navarra status: RECRUITING city: Pamplona state: Navarra zip: 31008 country: Spain name: Esperanza López-Franco, PhD role: CONTACT phone: 923291200 phoneExt: 55779 email: [email protected] name: Carlos Grande role: CONTACT lat: 42.81687 lon: -1.64323 facility: University Hospital of Navarra status: NOT_YET_RECRUITING city: Pamplona state: Navarra country: Spain name: Esperanza López-Franco role: CONTACT phone: 923291200 phoneExt: 55779 email: [email protected] name: María Carmen Mateos-Rodríguez role: CONTACT lat: 42.81687 lon: -1.64323 facility: Hospital Clínic status: NOT_YET_RECRUITING city: Barcelona country: Spain name: Esperanza López-Franco, PhD role: CONTACT phone: 923291200 phoneExt: 55779 email: [email protected] name: Valentín Ortiz-Maldonado role: CONTACT lat: 41.38879 lon: 2.15899 facility: Fundación Jiménez Díaz Hospital status: NOT_YET_RECRUITING city: Madrid country: Spain name: Esperanza López-Franco role: CONTACT phone: 923291200 phoneExt: 55779 email: [email protected] name: Javier Cornago-Navascués role: CONTACT lat: 40.4165 lon: -3.70256 facility: Salamanca University Health Care Complex status: RECRUITING city: Salamanca zip: 37007 country: Spain name: Esperanza López-Franco, PhD role: CONTACT phone: 923291200 phoneExt: 55779 email: [email protected] name: Lucía López-Corral, PhD role: CONTACT lat: 40.96882 lon: -5.66388 facility: Virgen del Rocio Hospital status: NOT_YET_RECRUITING city: Sevilla country: Spain name: Esperanza López-Franco, PhD role: CONTACT phone: 923291200 phoneExt: 55779 email: [email protected] name: José Antonio Pérez-Simón role: CONTACT lat: 37.38283 lon: -5.97317 hasResults: False |
<|newrecord|> nctId: NCT06378177 id: LVGN6051-0402-HNSCC briefTitle: A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC) overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2027-10-31 date: 2027-10-31 date: 2024-04-22 date: 2024-04-26 name: Lyvgen Biopharma Holdings Limited class: INDUSTRY briefSummary: The purpose of this study is to assess the safety and efficacy of LVGN6051 (4-1BB agonistic antibody) combined with toripalimab (anti-PD-1 antibody) and paclitaxel (anti-tubulin chemotherapy) in patients with recurrent/metastatic head and neck squamous cell carcinoma who rapidly progress from previous neoadjuvant, curative, or adjuvant platinum-containing therapy, or who are currently contraindicated for platinum-containing treatment. conditions: Head and Neck Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: This is a multicenter, open-labeled, single-arm Phase 2 clinical study.This study comprises two parts. Part 1 (Safety Run-in Phase) is designed to confirm the dose of combination therapy in Part 2. primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: LVGN6051 Monoclonal Antibody Injection name: toripalimab Injection name: Paclitaxel injection measure: to determine treatment-related adverse events (TRAEs, the safety and tolerability of two preset dose levels ) measure: to determine objective response rate (ORR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Cancer Hospital city: Hefei state: Anhui zip: 230000 country: China name: Jin Gao role: CONTACT phone: +86 15395005376 email: [email protected] lat: 31.86389 lon: 117.28083 facility: Beijing Cancer Hospital city: Beijing state: Beijing zip: 100142 country: China name: Yan Sun role: CONTACT phone: +86 13671370026 email: [email protected] lat: 39.9075 lon: 116.39723 facility: Beijing Tongren Hospital Affiliated to Capital Medical University city: Beijing state: Beijing zip: 100730 country: China name: Shurong Zhang role: CONTACT phone: +86 13501085646 email: [email protected] lat: 39.9075 lon: 116.39723 facility: Fujian cancer hospital city: Fuzhou state: Fujian zip: 350014 country: China name: Sufang Qiu role: CONTACT phone: +86 13609589163 email: [email protected] lat: 26.06139 lon: 119.30611 facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University city: Guangzhou state: Guangdong zip: 510120 country: China name: Xiaoming Huang role: CONTACT phone: +86 13602808820 email: [email protected] lat: 23.11667 lon: 113.25 facility: Guangxi Medical University Cancer Hospital city: Nanning state: Guangxi zip: 530021 country: China name: Song Qu role: CONTACT phone: +86 13607887386 email: [email protected] lat: 22.81667 lon: 108.31667 facility: Henan cancer hospital city: Zhengzhou state: Henan zip: 450008 country: China name: Hui Wu role: CONTACT phone: +86 13503716710 email: [email protected] lat: 34.75778 lon: 113.64861 facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430000 country: China name: Kunyu Yang role: CONTACT phone: +86 13995595360 email: [email protected] lat: 30.58333 lon: 114.26667 facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China name: Guangyuan Hu role: CONTACT phone: +86 13886000095 email: [email protected] lat: 30.58333 lon: 114.26667 facility: Xiangya Hospital Central South University city: Changsha state: Hunan zip: 410008 country: China name: Liangfang Shen role: CONTACT phone: +86 13975805137 email: [email protected] lat: 28.19874 lon: 112.97087 facility: The Second Xiangya Hospital, Central South University city: Changsha state: Hunan zip: 410011 country: China name: Ping Liu role: CONTACT phone: +86 15084987287 email: [email protected] lat: 28.19874 lon: 112.97087 facility: Hunan Cancer Hospital city: Changsha state: Hunan zip: 410031 country: China name: Yaqian Han role: CONTACT phone: +86 18673176667 email: [email protected] lat: 28.19874 lon: 112.97087 facility: Hunan Cancer Hospital city: Changsha state: Hunan zip: 410031 country: China name: Jinguan Lin role: CONTACT phone: +86 13307318568 email: [email protected] lat: 28.19874 lon: 112.97087 facility: Liaoning cancer hospital city: Shenyang state: Liaoning zip: 110042 country: China name: Xia Li role: CONTACT phone: +86 189 0091 7377 email: [email protected] lat: 41.79222 lon: 123.43278 facility: Shanghai Oriental Hospital city: Shanghai state: Shanghai zip: 200123 country: China name: Ye Guo role: CONTACT phone: +86 13501678472 email: [email protected] lat: 31.22222 lon: 121.45806 facility: West China Hospital of Sichuan University city: Chengdu state: Sichuan zip: 610041 country: China name: Lei Liu role: CONTACT phone: +86 18980606231 email: [email protected] lat: 30.66667 lon: 104.06667 facility: Zhejiang Cancer Hospital city: Hangzhou state: Zhejiang zip: 310022 country: China name: Meiyu Fang role: CONTACT phone: +86 13750851650 email: [email protected] lat: 30.29365 lon: 120.16142 hasResults: False |
<|newrecord|> nctId: NCT06378164 id: P0041406 briefTitle: The Effect of Combined Volitional and Reactive Step Training in Reducing Falls Risk in Older Fallers overallStatus: RECRUITING date: 2023-12-01 date: 2025-04 date: 2026-04 date: 2024-04-22 date: 2024-04-22 name: The Hong Kong Polytechnic University class: OTHER name: Chinese University of Hong Kong name: Neuroscience Research Australia name: The University of New South Wales briefSummary: To examine the immediate and sustained effect of a 4-week combined volitional and reactive step training on fall risks in community-dwelling older fallers. conditions: Older Adults With a History of Falls studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 98 type: ESTIMATED name: Exercise name: Active Control measure: Choice Stepping Reaction Times measure: Spring Scale Test measure: Mini Balance Evaluation System Test measure: Motor Control Test measure: Falls Efficacy Scale - International measure: Trail-Making Test measure: Programme Adherence measure: Prospective Falls measure: Adverse Events sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: The Hong Kong Polytechnic University status: RECRUITING city: Hong Kong country: Hong Kong name: Freddy Man Hin LAM, PhD role: CONTACT phone: 27666720 email: [email protected] name: Freddy Man Hin LAM role: CONTACT name: Freddy Man Hin LAM, PhD role: PRINCIPAL_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False |
<|newrecord|> nctId: NCT06378151 id: 2023P002243 briefTitle: Time-limited Trials in the Emergency Department overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-02-28 date: 2025-09-30 date: 2024-04-22 date: 2024-04-22 name: Brigham and Women's Hospital class: OTHER briefSummary: A randomized controlled trial of a structured conversation between clinicians and patients/surrogates to facilitate shared decision-making for intensive care use in seriously ill older adults being admitted to the intensive care unit from the emergency department. conditions: Emergencies studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Clinician-level randomization primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: TLT training measure: Time to complete TLT conversations measure: Patient-reported acceptability of TLT conversations measure: Intervention fidelity measure: Clinician-reported feasibility measure: Clinician-reported satisfaction measure: EHR documentation by inpatient clinicians measure: Heard and understood measure: Patient-reported end-of-life quality of communication measure: Decisional regret scale measure: The number of days to the first family meeting in ICU measure: ICU length of stay (LOS) measure: Hospital LOS measure: The number of family meetings measure: ICU procedures (e.g., CPR, pressors, etc.) measure: ICU mortality measure: Patterns of hospital disposition measure: Rate of hospice utilization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 hasResults: False |
<|newrecord|> nctId: NCT06378138 id: ICP-CL-01203 briefTitle: ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2030-11-25 date: 2031-07-25 date: 2024-04-22 date: 2024-04-22 name: Beijing InnoCare Pharma Tech Co., Ltd. class: INDUSTRY briefSummary: Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma conditions: Hematologic Malignancies studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 226 type: ESTIMATED name: ICP-248 name: Orelabrutinib measure: Adverse events (AEs) and serious adverse events (SAEs) evaluation according to CTCAE V5.0 or iwCLL 2018 criteria measure: Changes from baseline in pulse. measure: Changes from baseline in blood pressure. measure: Changes from baseline in ECG QRS interval. measure: Changes from baseline in ECG QT interval. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Anhui Medical University city: Hefei state: Anhui zip: 230022 country: China name: Jian Ge role: CONTACT lat: 31.86389 lon: 117.28083 facility: Peking University Third Hospital city: Beijing state: Beijing zip: 100191 country: China name: Hongmei Jing role: CONTACT lat: 39.9075 lon: 116.39723 facility: The First Affiliated Hospital of Chongqing Medical University city: Chongqing state: Chongqing zip: 400016 country: China name: Xiaoqiong Tang role: CONTACT lat: 29.56278 lon: 106.55278 facility: Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical University city: Chongqing state: Chongqing zip: 400037 country: China name: Xixi Xiang role: CONTACT lat: 29.56278 lon: 106.55278 facility: Fujian Medical University Union Hospital city: Fuzhou state: Fujian zip: 350001 country: China name: Zhenshu Xu role: CONTACT lat: 26.06139 lon: 119.30611 facility: The First Affiliated Hospital of Xiamen University city: Xiamen state: Fujian zip: 361003 country: China name: Bing Xu role: CONTACT lat: 24.47979 lon: 118.08187 facility: Sun Yat-sen University Cancer Center city: Guangzhou state: Guangdong zip: 510055 country: China name: Yang Liang role: CONTACT lat: 23.11667 lon: 113.25 facility: The Fourth Hospital of Hebei Medical University city: Shijiazhuang state: Hebei zip: 050010 country: China name: Lihong Liu role: CONTACT lat: 38.04139 lon: 114.47861 facility: Nanyang City Center Hospital city: Nanyang state: Henan zip: 473005 country: China name: Chao Li role: CONTACT lat: 32.99472 lon: 112.53278 facility: Henan Provincial People's Hospital city: Zhengzhou state: Henan zip: 463599 country: China name: Zunmin Zhu role: CONTACT lat: 34.75778 lon: 113.64861 facility: Henan Cancer Hospital city: Zhenzhou state: Henan zip: 450003 country: China name: Keshu Zhou role: CONTACT lat: 32.28034 lon: 119.16999 facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430011 country: China name: Xiaoxi Zhou role: CONTACT lat: 30.58333 lon: 114.26667 facility: Union Hospital Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430022 country: China name: Guohui Cui role: CONTACT lat: 30.58333 lon: 114.26667 facility: The Second Xiangya Hospital, Central South University city: Changsha state: Hunan zip: 410012 country: China name: Hongling Peng role: CONTACT lat: 28.19874 lon: 112.97087 facility: Hunan Cancer Hospital city: Changsha state: Hunan zip: 410031 country: China name: Fang Zhou role: CONTACT lat: 28.19874 lon: 112.97087 facility: Jiangsu Province Hospital city: Nanjing state: Jiangsu zip: 210029 country: China name: Wei Xu role: CONTACT lat: 32.06167 lon: 118.77778 facility: The First Affiliated Hospital of Nanchang University city: Nanchang state: Jiangxi zip: 330006 country: China name: Fei Li role: CONTACT lat: 28.68396 lon: 115.85306 facility: Bethune First Hospital of Jilin University city: Changchun state: Jilin zip: 130061 country: China name: Ou Bai role: CONTACT lat: 43.88 lon: 125.32278 facility: The Second Hospital of Dalian Medical University city: Dalian state: Liaoning zip: 116023 country: China name: Xiuhua Sun role: CONTACT lat: 38.91222 lon: 121.60222 facility: Shengjing Hospital affiliated to China Medical University city: Shenyang state: Liaoning zip: Liaoning country: China name: Aijun Liao role: CONTACT lat: 41.79222 lon: 123.43278 facility: Shandong Cancer Hospital city: Jinan state: Shandong zip: 250117 country: China name: Ji Ma role: CONTACT lat: 36.66833 lon: 116.99722 facility: Linyi City Cancer Hospital city: Linyi state: Shandong zip: 276002 country: China name: Meifang Zheng role: CONTACT lat: 35.06306 lon: 118.34278 facility: Huashan Hospital city: Shanghai state: Shanghai zip: 200040 country: China name: Tong Chen role: CONTACT lat: 31.22222 lon: 121.45806 facility: The Second Affiliated Hospital of Xi'an Jiaotong University city: Xi'an state: Shanxi zip: 710004 country: China name: Jianli Wang role: CONTACT lat: 34.25833 lon: 108.92861 facility: Sichuan Provincial People's Hospital city: Chengdu state: Sichuan zip: 610072 country: China name: Xiaobing Huang role: CONTACT lat: 30.66667 lon: 104.06667 facility: Yibin Second People's Hospital city: Yibin state: Sichuan zip: 644002 country: China name: Shihua Huang role: CONTACT lat: 28.76667 lon: 104.62383 facility: Tianjin Medical University Cancer Institute and Hospital city: Tianjin state: Tianjin zip: 300181 country: China name: Lihua Qiu role: CONTACT lat: 39.14222 lon: 117.17667 facility: The Affiliated Cancer Hospital of Xinjiang Medical University city: Urumqi state: Xinjiang Uygur Autonomous Region zip: 830000 country: China name: Shujuan Wen role: CONTACT lat: 43.80096 lon: 87.60046 facility: The First Affiliated Hospital of Kunming Medical University city: Kunming state: Yunnan zip: 650032 country: China name: Mingxia Shi role: CONTACT lat: 25.03889 lon: 102.71833 facility: The First Affiliated Hospital of Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310003 country: China name: Wenjuan Yu role: CONTACT lat: 30.29365 lon: 120.16142 hasResults: False |
<|newrecord|> nctId: NCT06378125 id: CIR-NA I briefTitle: Evaluation of Safety and Pharmacokinetics of Oral Controlled-ileal-release Nicotinic Acid (CIR-NA) Compared to Immediate-release Nicotinic Acid and Placebo in Healthy Subjects and Subjects With Prediabetes overallStatus: RECRUITING date: 2022-12-19 date: 2024-12-31 date: 2025-06-01 date: 2024-04-22 date: 2024-04-22 name: University Hospital Schleswig-Holstein class: OTHER briefSummary: A double-blind, randomised, placebo-controlled, single-ascending and multiple-ascending dose trial to evaluate the safety and pharmacokinetics of oral controlled-ileal-release nicotinic acid (CIR-NA) compared to immediate-release nicotinic acid and placebo in healthy subjects and subjects with prediabetes. conditions: Safety Issues conditions: Pharmacokinetic studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: DOUBLE maskingDescription: Double (Participant, Investigator) whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: controlled-ileal-release nicotinic acid (SAD/ MAD/MD) single- and multiple-ascending dose (SAD/MAD) or multiple dose (MD) name: immediate-release nicotinic acid (SAD) name: Placebo controlled-ileal-release nicotinic acid (SAD/MAD) name: Placebo immediate-release nicotinic acid (SAD) measure: Treatment-Emergent Adverse Events [Safety and Tolerability] measure: Treatment-Emergent Serious Adverse Events [Safety and Tolerability] measure: Haemoglobin measure: White blood cells measure: Blood creatinine measure: Blood urea measure: Blood uric acid measure: Glomerular filtration rate measure: Blood ALT measure: Blood AST measure: Blood GGT sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Schleswig-Holstein, Campus Kiel status: RECRUITING city: Kiel state: Schleswig-Holstein zip: 24105 country: Germany name: Corinna Geisler, PhD role: CONTACT phone: +4943150022243 email: [email protected] lat: 54.32133 lon: 10.13489 hasResults: False |
<|newrecord|> nctId: NCT06378112 id: 2734/CEIH/2022 briefTitle: Extraction Socket Augmentation. A Clinical Study acronym: GTO overallStatus: RECRUITING date: 2022-05-20 date: 2025-01-15 date: 2025-12-30 date: 2024-04-22 date: 2024-04-22 name: Universidad de Granada class: OTHER briefSummary: Extraction socket preservation is defined as alveolar ridge preservation within the bone envelope remaining after tooth extraction, meanwhile ridge augmentation is defined as increasing the volume of alveolar ridge beyond the bony envelope at the time of tooth extraction. It is recommended to use in cases where extraction socket anatomy is intact. In contrast definition "extraction socket augmentation" defines alveolar ridge restoration when bony walls of the socket are partly or completely lost. In the case of severe loss (\> 50%) of the buccal bone plate, preservation of hard tissue with a prolonged healing time before implant placement has been suggested. |
The null hypothesis of this experimental work states that: (i) the two different bone graft materials gained the same amount of bone following horizontal ridge augmentation procedure; (i) the two different bone graft materials exhibit similar histological and histomorphometric results Therefore, the main purpose of the current study is to compare two different biomaterials using guided bone regeneration procedures in the ridge preservation/ augmentation (hard-tissue preservation). conditions: Edentulous Alveolar Ridge With Labial Resorption studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: * Group 1 (test group): Guided bone regeneration procedure with GTO® as bone graft and soft collagenated cortical membrane (OsteoBiol® Lamina; Tecnoss srl) as graft stabilizer. |
* Group 2 (control): Guided bone regeneration procedure with Apatos Mix® cortico-cancellous heterologous bone mix (OsteoBiol®; Tecnoss srl) as bone graft and soft collagenated cortical membrane (OsteoBiol® Lamina; Tecnoss srl) as graft stabilizer. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: GTO® measure: Dimensional bone changes sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dental School status: RECRUITING city: Granada zip: E18071 country: Spain name: Manuel Toledano, Professor role: CONTACT email: [email protected] name: Raquel Osorio role: CONTACT email: [email protected] name: Manuel Toledano, Professor role: PRINCIPAL_INVESTIGATOR name: Raquel Osorio, Professor role: SUB_INVESTIGATOR name: Cristina Vallecillo, PhD role: SUB_INVESTIGATOR name: Marta Vallecillo-Rivas, PhD role: SUB_INVESTIGATOR name: Manuel Toledano-Osorio, PhD role: SUB_INVESTIGATOR lat: 37.18817 lon: -3.60667 hasResults: False |
<|newrecord|> nctId: NCT06378099 id: InFaPro briefTitle: Evaluation of the Effect of Consensual Pharmaceutical Indication Protocols for the Treatment of Minor Ailments acronym: InFaPro overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-02 date: 2025-08 date: 2024-04-22 date: 2024-04-25 name: Universidad de Antioquia class: OTHER name: Farmacias Pasteur briefSummary: Minor ailments are non-serious, short-term health problems, not related to the patient's pathologies or to the desired or undesired effects of the medications they are taking. Pharmaceutical indication is the service provided in response to a patient's request, who comes to the pharmacy asking for a medication recommendation for a health problem; for this purpose, over-the-counter medications are used, which are pharmacological agents that can be acquired without a prescription. The practice of pharmaceutical indication turns self-medication into a safe and responsible practice, but it requires agreed-upon protocols. conditions: Community Pharmacy Services studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: An exploratory clinical trial with a baseline reference period of parallel groups will be conducted. The study will take place over a period of 10 months, during which 5 MA will be analyzed, and for each of them, patients will be followed up on days 3 to 5, and 7 to 10 post-care (intervention). Drugstores and drugstores/pharmacies (groups) will be randomized in a 1:1 ratio to enroll in the intervention group or the control group. primaryPurpose: OTHER masking: NONE maskingDescription: Blinding of the participants and the pharmacists involved in the care is not possible due to the nature of the intervention. count: 800 type: ESTIMATED name: Patient guided and followed by the pharmacist measure: Resolution time of the MA and the frequency of referral to a physician. measure: Characterization of the population visiting drugstore or drugstore/pharmacy measure: Identification of the presence and classification of the MA measure: Need to acquire an OTC medication to treat the MA sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06378086 id: TEO-PAS-2302 briefTitle: RHA® Redensity With New Anesthetic Agent Perioral Rhytids (PAS) overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-02 date: 2025-05 date: 2024-04-22 date: 2024-04-22 name: Teoxane SA class: INDUSTRY briefSummary: This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA® Redensity with new anesthetic agent is non-inferior to RHA® Redensity with lidocaine in terms of injection site pain felt by the subject during injection. |
At screening, the Principal Investigator (PI) evaluated subjects' perioral rhytid severity (using the Perioral Rhytid Severity Rating Scale; PR-SRS) to confirm eligibility and to establish a pre-treatment score for assessing aesthetic improvement. |
At Visit 1, RHA® Redensity with new anesthetic agent was administered in a random sequence (first or second injection) and side of the mouth (left or right) and RHA® Redensity with lidocaine was administered to the other side. Study subjects and the PI injecting study devices were blinded. |
Immediately after injection of an upper perioral quadrant, subjects rated the injection site pain experienced during injection using a 100 mm Visual Analog Scale (VAS). Injection site pain in each side of the mouth was also assessed at 15, 30, 45 and 60 minutes after injection of the upper quadrant. |
Safety evaluation consisted of AE assessments, a 30-day CTR (Common Treatment Response) diary and a follow-up call performed by the study site at 72 hours after injection. |
Subjects attended Visit 2 (30 days post-injection) where effectiveness and safety assessments were conducted. |
Subjects who presented with an unresolved clinically significant device related AE at Visit 2 received a optional follow-up phone call no later than 30 days after Visit 2. |
If the clinically significant AE remained unresolved, the Investigator requested that the subject attended the optional in-clinic follow-up visit (i.e., Visit 3) within 5 working days. Follow-up of the clinically significant AE continued until the AE was resolved or the TI determines that additional follow-up was not necessary. conditions: Pain conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Split-face design primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: RHA® Redensity with new anesthetic agent name: RHA® Redensity with lidocaine measure: Non-inferiority of RHA® Redensity with new anesthetic agent versus RHA® Redensity with lidocaine in terms of reducing pain during device injection into the upper perioral rhytids. measure: Difference between RHA® Redensity with new anesthetic agent versus RHA® Redensity with lidocaine in term of reducing pain at 15, 30, 45 and 60 minutes post-injection in each side of the mouth. sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: United States, New York city: New York state: New York zip: 10028 country: United States role: CONTACT phone: 212-472-2900 lat: 40.71427 lon: -74.00597 hasResults: False |
<|newrecord|> nctId: NCT06378073 id: DPT/Batch-Fall19/557 briefTitle: Effects of Chest Physiotherapy Exercise in Prevention of Pre and Post Operative Complications By Cardiac Surgery overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-05 date: 2024-06-01 date: 2024-09-01 date: 2024-04-22 date: 2024-04-22 name: Superior University class: OTHER briefSummary: "A randomized control trial will be conducted among 189 patients who have undergone cardiac surgery in past. The participants for this research will be patients of Pakistan Institute of Cardiology, University of Lahore Teaching Hospital, Azra Naheed Medical College and Bahria International Hospital. The chest physiotherapy technique will be applied on 2 controlled groups. |
In 94 patients the effects of chest physiotherapy will be checked post - operatively and the effects will be checked on other half pre - operatively. The data will be gathered on practical performance and treatment based along with questionnaire. The data collected will then be analyzed using SPSS" conditions: Surgery-Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 189 type: ACTUAL name: Incentive Spirometer name: Numeric Pain Rating Scale measure: Incentive Spirometer measure: Incentive Spirometer sex: ALL minimumAge: 48 Years maximumAge: 88 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azra Naheed Medical College, Superior University city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 facility: Bahria Hospital city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 facility: Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 facility: The University of Lahore Teaching Hospital city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 facility: Punjab Institute of Cardiology Hospital city: Lahore country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False |
<|newrecord|> nctId: NCT06378060 id: KM04 briefTitle: Clinical Study on Modified Allogeneic Hematopoietic Stem Cell Transplantation Regimen for Severe Aplastic Anemia overallStatus: RECRUITING date: 2024-03-01 date: 2026-04-01 date: 2027-04-01 date: 2024-04-22 date: 2024-04-22 name: Hematology department of the 920th hospital class: OTHER briefSummary: The aim of this study was to evaluate the safety and efficacy of a modified allogeneic hematopoietic stem cell transplantation regimen for aplastic anemia. conditions: Severe Aplastic Anemia studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Modified transplantation system measure: overall survival (OS) measure: Acute graft-versus-host disease incidence measure: Transplantation-related motality measure: Chronic graft-versus-host disease incidence measure: incidence of Intensive fungal disease measure: EB virus reactivation rate measure: CMV reactivation rate sex: ALL minimumAge: 3 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China status: RECRUITING city: Kunming state: Yunnan zip: 650000 country: China name: Wang PI sanbin, Doctor role: CONTACT phone: 0871-64774206 email: [email protected] lat: 25.03889 lon: 102.71833 hasResults: False |
<|newrecord|> nctId: NCT06378047 id: MCC-22325 briefTitle: Irreversible Electroporation & Pembro Immunotherapy in Locally Advanced Pancreatic Cancer overallStatus: RECRUITING date: 2024-04-10 date: 2027-04 date: 2027-04 date: 2024-04-22 date: 2024-04-22 name: H. Lee Moffitt Cancer Center and Research Institute class: OTHER name: Angiodynamics, Inc. briefSummary: This study aims to determine the safety and tolerability of combining sequential therapy of Irreversible Electroporation (IRE) and Immunotherapy (IO) for patients with locally advanced unresectable pancreas cancer following first-line treatment with chemotherapy and ablative stereotactic magnetic resonance image-guided adaptive radiation therapy (A-SMART). conditions: Pancreatic Cancer conditions: Locally Advanced Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 3 type: ESTIMATED name: Pembrolizumab name: Irreversible Electroporation measure: Safety and Tolerability measure: Progression-Free Survival (PFS) measure: Overall Survival (OS) measure: Objective Response Rate (ORR) 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: Alicia Chin role: CONTACT phone: 813-745-4673 email: [email protected] name: Victoria Kryliouk role: CONTACT email: [email protected] name: Mokenge Malafa, MD role: PRINCIPAL_INVESTIGATOR name: Mohammed Al-Jumayli, MD role: SUB_INVESTIGATOR name: Junsung Choi, MD role: SUB_INVESTIGATOR name: James Costello, MD, PhD role: SUB_INVESTIGATOR name: Aamir Dam, MD role: SUB_INVESTIGATOR name: Jason Denbo, MD role: SUB_INVESTIGATOR name: Sophie Dessureault, MD, PhD role: SUB_INVESTIGATOR name: Martine Extermann, MD, PhD role: SUB_INVESTIGATOR name: Jessica Frakes, MD role: SUB_INVESTIGATOR name: Pamela Hodul, MD role: SUB_INVESTIGATOR name: Sarah Hoffe, MD role: SUB_INVESTIGATOR name: Dae Won Kim, MD role: SUB_INVESTIGATOR name: Richard Kim, MD role: SUB_INVESTIGATOR name: Bela Kis, MD, PhD role: SUB_INVESTIGATOR name: Allan Lima Pereira, MD, PhD role: SUB_INVESTIGATOR name: Shaffer Mok, MD role: SUB_INVESTIGATOR name: Russell Palm, MD role: SUB_INVESTIGATOR name: Jose Pimiento, MD role: SUB_INVESTIGATOR name: Paulo Rodriguez, PhD role: SUB_INVESTIGATOR name: Christine Sam, MD role: SUB_INVESTIGATOR name: Andrew Sinnamon, MD role: SUB_INVESTIGATOR name: Amalia Stefanou, MD role: SUB_INVESTIGATOR name: Jonathan Strosberg, MD role: SUB_INVESTIGATOR lat: 27.94752 lon: -82.45843 hasResults: False |
<|newrecord|> nctId: NCT06378034 id: 2023-A01926-39 briefTitle: Effect of Lactium on Sleep Disorders in Healthy Volunteers With Persistent Subclinical Insomnia overallStatus: NOT_YET_RECRUITING date: 2024-06-10 date: 2024-07-15 date: 2026-09-30 date: 2024-04-22 date: 2024-04-22 name: Ingredia S.A. class: INDUSTRY briefSummary: The main objective will be to assess the effect of Lactium® on sleep efficiency in volunteers presented with persistent subclinical insomnia. conditions: Sleep Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: Lactium name: Placebo measure: Sleep efficiency measure: Sleep diary measure: Insomnia Severity Index measure: PSQI measure: Sleep quality by cctigraphy sex: ALL minimumAge: 25 Years maximumAge: 55 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06378021 id: Calcium chloride in CABG briefTitle: Role of Calcium Chloride Injection in Alleviating Atrial Fibrillation Post CABG overallStatus: RECRUITING date: 2024-03-14 date: 2025-03 date: 2025-04 date: 2024-04-22 date: 2024-04-22 name: Helwan University class: OTHER briefSummary: This study hypothesize that injecting calcium chloride (CaCl2) into the major atrial ganglionated plexus (GPs) during on pump Coronary artery bypass graft (CABG) can reduce the incidence of Post operative Atrial fibrillation in the first 7 days after surgery.The study is designed to be prospective interventional study two armed RCT for on pump CABG patient. |
The intervention arm will be injected with Calcium chloride in the four major atrial ganglionic plexus The control arm will be injected with sodium chloride to determine the effect of Calcium chloride on Post CABG Atrial fibrillation conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: Calcium Chloride name: Sodium Chloride 0.9% Inj measure: Change in number of patients who developed Atrial fibrillation measure: Change in length of hospital stay sex: ALL minimumAge: 18 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ain shams university status: RECRUITING city: Cairo state: Abassia Cairo zip: 02 country: Egypt name: Mohamed A Gamal, Ass prof role: CONTACT phone: 010080827060 phoneExt: 02 name: Abdelhameed I Ebid, Prof role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False |
<|newrecord|> nctId: NCT06378008 id: 300100 briefTitle: A Clinical Study to Evaluate the Anti-Sensitivity Effect of a Calcium Sodium Phosphosilicate Toothpaste in a Population of Dentin Hypersensitivity Sufferers overallStatus: RECRUITING date: 2024-04-16 date: 2024-09-13 date: 2024-09-13 date: 2024-04-22 date: 2024-04-22 name: HALEON class: INDUSTRY briefSummary: The aim of this study is to confirm the clinical dentin hypersensitivity (DH) efficacy of a 5 percent (%) calcium sodium phosphosilicate (CSPS) toothpaste. conditions: Dentin Sensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 234 type: ESTIMATED name: CSPS toothpaste name: Regular fluoride toothpaste (Crest Cavity Protection) measure: Change from Baseline in Schiff Sensitivity Score at Day 56 measure: Change from Baseline in Tactile Threshold at Day 56 measure: Change from Baseline in Schiff Sensitivity Score at Days 3, 7, 14 and 28 measure: Change from Baseline in Tactile Threshold at Days 3, 7, 14 and 28 measure: Change from Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56 measure: Change from Baseline in DHEQ Total Score (Section 2, Question Q1-34) at Days 28 and 56 measure: Change from Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56 measure: Change from Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56 measure: Change from Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56 measure: Change from Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56 measure: Change from Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56 measure: Change from Baseline in Global Oral Health (Section 2, Q35) Score at Days 28 and 56 measure: Change from Baseline in Effect on Life Overall (Section 2, Q36-39) Score at Days 28 and 56 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: All Sum Research status: RECRUITING city: Mississauga state: Ontario zip: L5N 6J2 country: Canada name: C R Goyal, Dr role: CONTACT lat: 43.5789 lon: -79.6583 hasResults: False |
<|newrecord|> nctId: NCT06377995 id: OST1_013 briefTitle: Effectiveness of an Intervention Plan Aimed at the Diaphragm in Chronic Non-specific Neck Pain overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2024-12-31 date: 2024-12-31 date: 2024-04-22 date: 2024-04-22 name: Escola Superior de Tecnologia da Saúde do Porto class: OTHER briefSummary: The aim of this study is to analyse the effectiveness of an intervention plan targeting the diaphragm, namely stretching technique, neuromuscular diaphragm and phrenic centre inhibition, in the treatment of chronic non-specific neck pain. conditions: Chronic Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Placebo technique name: Diaphragm protocol measure: Change in the intensity of pain in the cervical spine after applying the diaphragm intervention plan measure: Changes in range of motion after applying the diaphragm targeted protocol measure: Changes in pain level one week after the intervention measure: Changes in range of motion one week later sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Escola Superior de Saúde do Porto city: Porto zip: 4200-072 country: Portugal name: Natália MO Campelo, PhD role: CONTACT phone: +35122 206 1000 email: [email protected] name: Natália MO Campelo, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.14961 lon: -8.61099 hasResults: False |
<|newrecord|> nctId: NCT06377982 id: SCCP001 briefTitle: Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-09 date: 2026-12 date: 2024-04-22 date: 2024-04-22 name: StemCyte Taiwan Co., Ltd. class: INDUSTRY briefSummary: A phase I, randomized, double-blind, placebo-controlled clinical study to assess the safety and efficacy of allogeneic human umbilical cord blood infusion in children with cerebral palsy conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 12 type: ESTIMATED name: hUCB measure: safety-TEAE sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06377969 id: 75269 briefTitle: Prospective Evaluation of Effectiveness and Safety of Closed-Loop Spinal Cord Stimulation in Treating Patients With Chronic Pelvic Pain overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-12-31 date: 2027-06-30 date: 2024-04-22 date: 2024-04-26 name: Stanford University class: OTHER briefSummary: Spinal cord stimulation (SCS) is an effective treatment for patients with chronic pelvic pain. The investigators will evaluate how safe and effective closed-loop spinal cord stimulation is in treating these patients; closed-loop spinal cord stimulation is a more novel method in delivering spinal cord stimulation that controls energy output of the device based on real-time feedback on how the device is stimulating the spinal cord. conditions: Chronic Pelvic Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pilot prospective single arm interventional study primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation measure: Change in Pain Intensity measure: Change in Disability measure: Patient Global Impression Change measure: Change in Quality of Life measure: Change in Pain Catastrophizing Scale measure: Change in sleep quality measure: Change in Social Functioning sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06377956 id: XRGao briefTitle: The Associations Between Gut Length, Gut Microbiota and Food Assimilation overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-01 date: 2025-06-01 date: 2024-04-22 date: 2024-04-22 name: Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences class: OTHER briefSummary: The purpose of this observational study is to explore the correlation between human gut length and food absorption rates. This will include characterization of gut length, total food intake energy, fecal calories, urinary calories, body composition, food intake behavior, genetics and gut microbiota in the small intestine. Researchers expect to recruit up to 100 healthy volunteers. conditions: Gut Length conditions: Food Assimilation Efficiency studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Observation without intervention measure: Gut length measure: Energy intake measure: Fecal calorie measure: Urine calorie measure: Weight measure: Height measure: Waist circumferences measure: Hip circumferences measure: Bone mass measure: Fat mass measure: Fat free mass measure: Blood pressure measure: Heart rate measure: Resting energy expenditure measure: Thermic effect of food measure: Body shape measure: Microbiome measure: Metabolites measure: Gut transit time measure: Food macronutrient content measure: Feces macronutrient content measure: Total daily water volume measure: Total daily urine volume measure: Physical activity measure: Bristol Stool Scale sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Shenzhen Institute of Advanced Technology city: Shenzhen state: Guangdong zip: 518055 country: China name: John R Speakman, PhD role: CONTACT phone: 13466654659 email: [email protected] lat: 22.54554 lon: 114.0683 hasResults: False |
<|newrecord|> nctId: NCT06377943 id: SIAT-IRB-240415-H0718 briefTitle: The Interaction Between Resting Metabolic Rate, Physical Activity and Thyroid Hormone in Females overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-31 date: 2024-10-31 date: 2024-04-22 date: 2024-04-22 name: Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences class: OTHER briefSummary: This Study is focused on the interaction between resting metabolic rate (RMR), physical activity (PA), and thyroid hormones (TH). TH controls almost all the cell activities of the body so, it is known as one of the major regulatory hormones. This is the reason for individuals who suffer from thyroid disorders show abnormal metabolism. Recently it was suggested that interindividual variations in thyroid hormone levels also influence daily physical activity. conditions: Thyroid conditions: Physical Activities conditions: Resting Energy Expenditure studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Body weight measure: Height measure: Waist and Hip circumferences measure: Fat mass measure: Far free mass measure: Bone mass measure: Resting Metabolism measure: Physical activity measure: Thyroid hormone measure: Total energy expenditure sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06377930 id: RAP-219-FOS-201 briefTitle: Study Evaluating the Safety and Efficacy of RAP-219 in Adult Participants With Refractory Focal Epilepsy overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-03-01 date: 2025-06-01 date: 2024-04-22 date: 2024-04-26 name: Rapport Therapeutics Inc. class: INDUSTRY briefSummary: This is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy. This study is being conducted to determine if RAP-219 works and is safe in patients with Refractory Focal Epilepsy. conditions: Focal Onset Seizures studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: RAP-219 measure: Efficacy in reducing frequency of RNS-recorded long episodes in participants with FOS measure: Measurement of estimated electrographic seizure frequency from available RNS-recorded episodes measure: Measurement of Clinical Seizure Frequency measure: Change in seizure severity measure: Global Impression of Change measure: Pharmacokinetic parameters sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06377917 id: 2304-BRG-057-JF briefTitle: Investigating Micro-Manipulation Procedures for Assisted Hatching Timing acronym: IMPACT overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-05 date: 2024-04-22 date: 2024-04-22 name: Reproductive Medicine Associates of New Jersey class: OTHER briefSummary: This study aims to assess the clinical significance of cleavage stage (Day 3) assisted hatching compared to assisted hatching at the blastocyst stage (Day 5,6,7) of embryo development at the time of trophectoderm (TE) biopsy for patients undergoing in vitro fertilization (IVF) and preimplantation genetic testing for aneuploidy (PGT-A) for treatment of their infertility. conditions: Infertility studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: Laser Assisted Hatching measure: Blastulation Rate measure: Embryo morphologic grade measure: Timing of blastulation measure: Aneuploidy rate measure: Positive pregnancy rate measure: Sustained implantation rate measure: Pregnancy loss rate measure: Live birth rate sex: FEMALE minimumAge: 18 Years maximumAge: 42 Years stdAges: ADULT facility: Reproductive Medicine Associates of New Jersey city: Marlton state: New Jersey zip: 08053 country: United States name: Christine V Whitehead, MS, BSN, RN role: CONTACT phone: 973-656-2841 email: [email protected] name: Caroline Zuckerman, BS, RN role: CONTACT phone: 19736562841 email: [email protected] name: Jason Fransiak, MD role: PRINCIPAL_INVESTIGATOR name: Kevin Lambrese, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.89122 lon: -74.92183 hasResults: False |
<|newrecord|> nctId: NCT06377904 id: 2023-A02125-40 briefTitle: Clinical and Therapeutic Characteristics of Geriatric Patients Hospitalized for Heart Failure (AGING HF Study (AGe and Heart Failure IN Geriatrics)) acronym: AGING HF overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2028-04 date: 2024-04-22 date: 2024-04-22 name: Gérond'if class: OTHER briefSummary: This retrospective (between April 2020 and December 2023) then prospective (between January 2024 and August 2026), non-interventional cohort study has as its main objective to evaluate the clinical and therapeutic characteristics of patients aged 75 and over hospitalized in geriatrics for heart failure and also to evaluate the clinical characteristics and triggering factor(s) of acute heart failure. conditions: Patients Hospitalized in Geriatrics for Heart Failure conditions: Patients Aged 75 and Over studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 810 type: ESTIMATED measure: Evaluate the clinical and therapeutic characteristics of elderly patients hospitalized in geriatrics for heart failure measure: Factors associated with patients hospitalization or rehospitalization sex: ALL minimumAge: 75 Years stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06377891 id: TDK-2024-13563 briefTitle: The Effect of Emotional Resilience Training on Fear of Birth and Depression in Primiparous Pregnant Women overallStatus: ENROLLING_BY_INVITATION date: 2024-04-16 date: 2024-10-30 date: 2024-12-30 date: 2024-04-22 date: 2024-04-22 name: Ataturk University class: OTHER name: Atatürk University briefSummary: Although birth has a great place in a woman's life, factors such as the woman's education level, personal experiences, social support status, whether the pregnancy is planned or not, the family's attitude towards pregnancy, and socioeconomic status increase the burden of pregnancy and can create a stressful situation for the woman. While the pain that may be experienced during birth, thoughts about the baby's health and postpartum baby care further increase this fear, primiparous women who will give birth for the first time experience many emotions that they cannot define and cannot predict the situations they will encounter during birth. The most important situation that will cause pain during birth is fear. So much so that fear of birth may cause women to avoid pregnancy and increase optional abortions.In particular, fear of birth may increase cesarean delivery rates and also lead to negative maternal outcomes such as poor mental health after birth. Fear experienced during the antenatal period can lead to difficult births, mother-baby attachment problems, and depression. While fear of birth causes depression and anxiety disorders in the postpartum period, it is stated that depression experienced during pregnancy may increase the fear of birth, or fear of birth may be a hidden symptom of depression. It is noted that emotional regulation skills and resilience in pregnant women can be effective strategies in minimizing and managing fear, anxiety, stress, and anxiety. Emotional resilience is defined as the style of coping with stress, the ability to repair oneself, the ability to recover from adverse events quickly, and the state of adapting to a new environment. In particular, individuals with high emotional resilience can protect their physical and mental health and increase their life satisfaction by reducing the negative consequences they experience. With the emotional resilience training given during pregnancy, pregnant women's stress, fear, and anxiety will be reduced, and they will be able to cope better with the difficulties they experience. This research will be conducted to examine the effect of emotional resilience training given to primiparous pregnant women on fear of childbirth and depression. conditions: Fear of Childbirth conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Emotional Resilience training measure: The effect of emotional resilience on fear of birth and depression in primiparous pregnant women. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bayburt State Hospital city: Bayburt zip: 69000 country: Turkey lat: 40.25631 lon: 40.22289 hasResults: False |
<|newrecord|> nctId: NCT06377878 id: Pro00008369 briefTitle: The Preeclampsia Registry acronym: TPR overallStatus: RECRUITING date: 2013-09-01 date: 2040-05 date: 2040-05 date: 2024-04-22 date: 2024-04-22 name: Preeclampsia Foundation class: OTHER briefSummary: The purpose of The Preeclampsia Registry is to collect and store medical and other information from women who have been medically diagnosed with preeclampsia or a related hypertensive (high blood pressure) disorder of pregnancy such as eclampsia or HELLP syndrome, their family members, and women who have not had preeclampsia to serve as controls. Information from participants will be used for medical research to try to understand why preeclampsia occurs, how to predict it better, and to develop experimental clinical trials of new treatments. The Registry will consist of a web-based survey and mechanism for collecting and reviewing medical records. This data will be utilized for immediate investigator-driven cross-sectional research projects (after proposal review by the Registry's scientific advisory board and as directed by the PI). Participants may also choose to be contacted regarding possible participation in future studies, about providing a biospecimen, as well as investigator-driven clinical trials. The Registry is anticipated to exist long-term and to serve as a foundation of participants from which to draw for studies of preeclampsia, anticipated to evolve as our scientific understanding of preeclampsia evolves. conditions: Preeclampsia conditions: Eclampsia conditions: HELLP Syndrome conditions: Toxemia conditions: Hypertensive Disorder of Pregnancy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 20000 type: ESTIMATED measure: Self Reported Diagnosis of Preeclampsia and Hypertensive Disorders of Pregnancy Confirmed by Medical Records sex: ALL minimumAge: 13 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Preeclampsia Foundation status: RECRUITING city: Melbourne state: Florida zip: 32940 country: United States name: VeeAnn Argyle role: CONTACT phone: 321-421-6957 email: [email protected] name: Eleni Z Tsigas, BA role: PRINCIPAL_INVESTIGATOR name: Hilary Gammill, MD role: SUB_INVESTIGATOR name: James Roberts, MD role: SUB_INVESTIGATOR lat: 28.08363 lon: -80.60811 hasResults: False |
<|newrecord|> nctId: NCT06377865 id: endocrine dis & B thalassemia briefTitle: Thyroid Function , HbA1c in Relation to Ferritin Level in Adullt Patient e B Thalassemia overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-11-01 date: 2026-05-01 date: 2024-04-22 date: 2024-04-22 name: Assiut University class: OTHER briefSummary: to evaluate thyroid function ,HbA1C,\&lipid profile in thalassemic patient to correlate thyroid function , Hba1c , lipid profile e ferritin level in thalassemic patient conditions: B Thalassemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 72 type: ESTIMATED measure: Thyroid function ,Hba1c in relation to ferritin level in adult patients with beta thalassemia sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06377852 id: Pro00075309 briefTitle: The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study overallStatus: NOT_YET_RECRUITING date: 2024-10-28 date: 2028-08-31 date: 2028-09-01 date: 2024-04-22 date: 2024-04-22 name: American Society of Clinical Oncology class: OTHER name: Patient-Centered Outcomes Research Institute briefSummary: The purpose of this study is to generate evidence on an alternative dosing strategy for CDK4/6 inhibitors to help more patients with MBC (age ≥ 65 years) tolerate side effects and stay on treatment longer, to derive the most clinical benefit from these drugs. |
The primary objective of the CDK Study is to compare TTD on the approved dosing for palbociclib (125 mg orally daily on days 1-21 of 28-day cycle) or ribociclib (600 mg orally daily on days 1-21 of 28-day cycle) vs. TTD using titrated dosing approach with the same schedule but starting at a lower dose of palbociclib (100 mg or 75 mg) or ribociclib (400 mg or 200 mg) and escalating the dose if well-tolerated in combination with provider/patient choice endocrine therapy (AI or fulvestrant) in patients age 65 or older with HR+/HER2- MBC. The secondary and exploratory objectives will generate evidence needed to personalize treatment decisions by comparing patient-centric secondary outcomes and evaluating baseline factors. |
Together with their treating physician, participants will choose the CDK4/6 inhibitor (palbociclib or ribociclib) and which endocrine therapy (aromatase inhibitor or fulvestrant) of their choice but will be randomized to either Arm 1 (indicated dosing) or Arm 2 (titrated dosing). conditions: Metastatic Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 500 patients will be enrolled, 250 per arm (Arm 1 being indicated dose, Arm 2 being titrated dose). primaryPurpose: TREATMENT masking: NONE count: 500 type: ESTIMATED name: Palbociclib name: Ribociclib measure: Time to Treatment Discontinuation (TTD) measure: Toxicity (grade 3-4 AEs) measure: Event-Free survival (EFS) measure: Quality of life assessed by patient reported outcomes measure: Time to dose reduction and escalation measure: Reason for not escalating measure: Treatment received (missed doses, cumulative dose, etc.) measure: Healthcare utilization (ED visits, hospital admissions, etc.) measure: Body Mass Index sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06377839 id: N-20230048 briefTitle: Pain After Removal of Mandibular Third Molars With or Without Advanced Platelet-rich Fibrin overallStatus: RECRUITING date: 2024-01-10 date: 2024-04-17 date: 2025-12-01 date: 2024-04-22 date: 2024-04-22 name: Aalborg University Hospital class: OTHER name: Aalborg University briefSummary: Pain is the most common complication following surgical removal of an impacted mandibular third molar. Several risk factors may increase the intensity and duration of pain following removal of mandibular third molars. Acute postoperative pain can transcript into postoperative chronic pain without an explainable reason or a specific risk factor. The use of advanced platelet-rich fibrin in the extraction socket following surgical removal of mandibular third molar have diminished the intensity and duration of acute postoperative pain and facilitated improved wound healing. The objective of the present study is therefore to identified specific risk factors and predictors for developing postoperative chronic pain following surgical removal of mandibular third molars with or without advanced platelet-rich fibrin applied in the extraction socket using epigenetic modulation. conditions: Pain Syndrome studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Advanced platelet-rich fibrin in the ekstraction socket measure: Assessment of postoperative pain by using Visual Analoque scale measure: Assessment of quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Oral and Maxillofacial surgery, Aalborg University Hospital status: RECRUITING city: Aalborg state: Nordjylland zip: 9000 country: Denmark name: Thomas Starch-Jensen, Professor role: CONTACT phone: +45 23266370 email: [email protected] lat: 57.048 lon: 9.9187 hasResults: False |
<|newrecord|> nctId: NCT06377826 id: RCRAHS-ISB/REC/MS-PT/01813 briefTitle: Comparison of Aerobic and Resistance Training on Exercise Capacity, Depression and Quality of Life in Hypothyroidism. overallStatus: RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-06-01 date: 2024-04-22 date: 2024-04-22 name: Riphah International University class: OTHER briefSummary: the study will show the effects of aerobic and resistance training on exercise capacity, depression and quality of life in patients with hypothyroidism. The evaluation of TSH level before and after the exercise sessions will provide valuable data. conditions: Comparison of Aerobic Exercise and Resistance Training studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 66 type: ESTIMATED name: aerobic exercises name: resistance training name: medication measure: 6 Minute Walk Test measure: The Beck Depression Inventory Scale measure: SF- 36 SF-36 sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: Abbottabad medical complex status: RECRUITING city: Abbottābād state: Khyber Pakhtunkhwa zip: 21300 country: Pakistan name: saira jahan, MS role: CONTACT phone: 031591289095 email: [email protected] name: Usama Iqbal role: PRINCIPAL_INVESTIGATOR lat: 34.1463 lon: 73.21168 hasResults: False |
<|newrecord|> nctId: NCT06377813 id: REC/RCR& AHS/23/01100/Maryam briefTitle: Combined Mode-Kinetic Chain Exercise With and Without Core Stability Exercises on Patients With Knee Osteoarthritis overallStatus: RECRUITING date: 2023-11-20 date: 2024-06-01 date: 2024-06-01 date: 2024-04-22 date: 2024-04-22 name: Riphah International University class: OTHER briefSummary: The goal of this \[type of study: Randomized control trial\] is to \[ see the effects of Combined Mode Kinetic Chain Exercises along with or without core stability exercises on pain, range of motion and disability \] in \[ in patients with Knee Osteoarthritis\].The main question it aims to answer is: |
Wether core stability exercises is effective if performed along with Combined chain kinetic exercises to improves the condition of Knee Osteoarthritis? Group A will receive Core Stability Exercises along with Combined Chain Kinetic Exercises and Group B will receive combined Chain Kinetic Exercises. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Assignment primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Mode-Kinetic Chain Exercise With Core Stability Exercises name: Mode-Kinetic Chain Exercise measure: Numeric pain rating scale measure: Kellgren and Lawrence system for classification of Osteoarthritis measure: Knee Injury and Osteoarthritic outcome score (KOOS) measure: Goniometer sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Riphah International University status: RECRUITING city: Lahore state: Punjab zip: 54000 country: Pakistan name: Muhammad Sanaullah, MS role: CONTACT phone: 03224819253 email: [email protected] name: Maryam Maqsood, DPT role: CONTACT phone: 03314815652 email: [email protected] lat: 31.558 lon: 74.35071 hasResults: False |
<|newrecord|> nctId: NCT06377800 id: REC 01801 Kainat Fatima briefTitle: Effects Of Navicular Mobilization In Patients With Planter Fasciitis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-07 date: 2024-04-22 date: 2024-04-22 name: Riphah International University class: OTHER briefSummary: The significance of studying the effects of navicular mobilization in patients suffering from plantar fasciitis lies in its potential to provide valuable insights into non-invasive treatment approaches for a common and debilitating foot condition such as flat foot. Understanding how this therapy impacts navicular height, pain and disability of the foot can lead to improved clinical outcomes and a better understanding of the biomechanical factors contributing to plantar fasciitis. Ultimately, this research may help refine treatment strategies and enhance the quality of life for individuals suffering from this condition conditions: Plantar Fascitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: navicular mobilization along conventional therapy. name: conventional therapy measure: Numeric Pain Rating Scale measure: (Foot Function Index) measure: Navicular drop test measure: Foot print analysis sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: DHQ Hospital city: Faisalābad state: Punjab country: Pakistan name: Maria Khalid, MSOMPT role: CONTACT phone: 03315369768 email: [email protected] name: Kainat Fatima, MSOMPT* role: CONTACT name: Kainat Fatima, MSOMPT* role: PRINCIPAL_INVESTIGATOR lat: 31.41554 lon: 73.08969 hasResults: False |
<|newrecord|> nctId: NCT06377787 id: REC 01732 Aneeqa Zaheer briefTitle: Effects of ELDOA in Patients With Cervicogenic Headache overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-07 date: 2024-04-22 date: 2024-04-22 name: Riphah International University class: OTHER briefSummary: The aim of our study is to determine the effect of ELDOA in relieving pain, improving ROM and functional disability in patients with cervicogenic headache. This study will add to the growing body of knowledge that if this technique yields comparable outcomes, it would be the alternative therapy. Moreover, it would add to the society as no literature is available on the effect of ELDOA technique in the management of Cervicogenic headache. conditions: Cervicogenic Headache studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: ELDOA and conventional therapy name: conventional therapy measure: (Numeric Pain Rating Scale). measure: NDI (U) (Neck Disability Index) measure: Inclinometer sex: ALL minimumAge: 30 Years maximumAge: 45 Years stdAges: ADULT facility: Alkhidmat Raazi Hospital CBR Town city: Islamabad state: Punjab zip: 46000 country: Pakistan name: Maria Khalid, MSOMPT role: CONTACT phone: 03315369768 email: [email protected] name: Aneeqa Zaheer, MSOMPT* role: CONTACT name: Aneeqa Zaheer, MSOMPT* role: PRINCIPAL_INVESTIGATOR lat: 33.72148 lon: 73.04329 hasResults: False |
<|newrecord|> nctId: NCT06377774 id: NFEC-2024-096 briefTitle: To Optimize Therapeutic Procedures of DPMAS in ACLF Patients: a Prospective, Sigle Arm and Multicenter Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-03-30 date: 2026-02-01 date: 2024-04-22 date: 2024-04-22 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: Acute-on-chronic liver failure (ACLF) is a life-threaten syndrome carrying high-short-term mortality raging 40% to 60% within 90 days in patients with chronic liver disease. Double plasma molecular adsorption system (DPMAS) is one of the available artificial liver support systems, which combines plasma filtration and two specific adsorption membranes dedicating to remove bilirubin and the middle molecular toxins respectively. The efficiency of DMPAS treatment in liver failure patients remains controversial. Previous study indicate that liver failure patients with DPMAS therapy improve the short-term mortality and prevent the diseases progression within 28 days (PADSTONE Study). Thus, this single-arm, multicenter and prospective study is to further validate and optimize the therapeutic procedures of DPMAS therapy in ACLF patients. conditions: Acute-On-Chronic Liver Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: No intervention in this study measure: 28-day transplantation-free mortality measure: The disease progression rate measure: the 90-day transplantation-free mortality measure: the disease progression sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06377761 id: BF-2022-121 briefTitle: Study on Heart Failure With Preserved Ejection Fraction With Qishen Granules overallStatus: RECRUITING date: 2023-05-01 date: 2024-12-31 date: 2025-12-31 date: 2024-04-22 date: 2024-04-22 name: Guangdong Provincial Hospital of Traditional Chinese Medicine class: OTHER briefSummary: With the cardiopulmonary exercise testing as the primary outcome, the study aims to evaluate the efficacy of Qishen Granules on cardiac function, quality of life and biomarker level of patients with heart failure with preserved ejection fraction (HFpEF), which will provide evidence for the treatment of HFpEF with traditional Chinese medicine. conditions: Heart Failure With Preserved Ejection Fraction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Random parallel grouping primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Qishen Granules name: Placebo measure: Changes in peak oxygen uptake within the average minute (PeakVO2) compared to baseline on day 90 measure: Changes in Mitral valve diastolic blood flow velocity (E) and Mitral annulus lateral and septal motion velocity (e') compared to baseline on day 90 measure: Changes in E/e' ratio compared to baseline on day 90 measure: Changes in Left Atrial Volume index (LAVI) compared to baseline on day 90 measure: Changes in Left ventricular mass index (LVMI) compared to baseline on day 90 measure: Changes in Score of Kansas City Cardiomyopathy Questionnaire (KCCQ) compared to baseline on day 90 measure: Changes in blood N terminal pro B type natriuretic peptide(NT-proBNP) compared to baseline on day 90 measure: Changes in blood Growth STimulation expressed gene 2(ST2) compared to baseline on day 90 measure: Changes in blood urea compared to baseline on day 90 measure: Changes in blood creatinine compared to baseline on day 90 measure: Changes in Aspartate aminotransferase(AST) compared to baseline on day 90 measure: Changes in Alanine aminotransferase(ALT) compared to baseline on day 90 measure: Number of participants with treatment-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Provincial Hospital of Chinese Medicine status: RECRUITING city: Guangzhou state: Guangdong zip: 510120 country: China name: Lei Wang, M.D role: CONTACT phone: 8620-81887233-32801 email: [email protected] lat: 23.11667 lon: 113.25 facility: WangLei status: RECRUITING city: Guangzhou state: Guangdong zip: 510120 country: China name: Lei Wang, doctorate role: CONTACT phone: +8613724078381 email: [email protected] name: Shuai Mao, doctorate role: CONTACT phone: 86-20-81887233-32801 email: [email protected] lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06377748 id: 2023/02 briefTitle: The Effect of Facilitated-tucking and ShotBlocker on Pain Caused by Vaccination in Healthy Infants overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-30 date: 2024-07-30 date: 2024-04-22 date: 2024-04-22 name: Istanbul Medeniyet University class: OTHER briefSummary: This study will be investigated the effects of facilitated tucking, ShotBlocker and combined facilitated tucking and ShotBlocker methods on procedural pain, crying time and duration of the procedure during Hepatitis B vaccine administration in healthy term infants. conditions: Procedural Pain conditions: Pain, Acute conditions: Nursing Caries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be assigned to experimental and control groups using block randomization method. Birth weight (2500-3000 g, 3001-3500 g, 3501 g and above), gender (male and female) and mode of delivery (vaginal and cesarean section) variables will be used for block randomization. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Using the block randomization technique, participants will be divided into 4 groups. A web-based randomization list creation tool will be used to create the blocked randomization list. Control and intervention groups will be coded as A, B, C and D using the sealed envelope method. Randomization information will be kept from the researcher involved in data collection until data collection begins. The researcher will learn which group each baby is in just before the application (researcher blinding). |
Parents will know which group the baby is in within the scope of the research. By the nature of the sample group, babies are blind. |
Research data will be entered into the computer database by coding the group name as A, B, C and D, and statistical analysis will be performed using this coding (statistician blinding). whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 144 type: ESTIMATED name: Facilitated tucking position name: ShotBlocker name: Combined facilitated tucking and ShotBlocker measure: Neonatal Infant Pain Scale measure: Crying time during the procedure measure: Procedure time sex: ALL minimumAge: 38 Weeks maximumAge: 42 Weeks stdAges: CHILD facility: Istanbul Medeniyet University city: Istanbul state: Kadıköy zip: 34720 country: Turkey name: Aynur Aytekin Özdemir, PhD role: CONTACT lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06377735 id: CHEST-001 briefTitle: BAI-BACE for Advanced Lung Squamous Cell Carcinoma overallStatus: RECRUITING date: 2024-05-01 date: 2025-12-30 date: 2026-12-30 date: 2024-04-22 date: 2024-04-24 name: Sun Yat-sen University class: OTHER briefSummary: Bronchial arterial infusion plus bronchial arterial chemoembolization (BAI-BACE) has been reported as non-first-line therapy to treat lung cancer in many hospitals in China. BAI, which uses chemotherapeutic drugs directly injected into the tumor and achieved a high concentration in a short time to kill the tumor. Then BACE could seal off the tumor vessels. In this study, we aim to describe the efficacy and safety of BAI-BACE as non-first-line for advanced lung squamous cell carcinoma. conditions: Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Bronchial arterial infusion, bronchial arterial chemoembolization (BACE-BAI) procedure was performed as follows: Bronchial arteriography was performed to find tumor-feeding artery. After the catheter had been inserted into the tumor-feeding artery, paclitaxel (300 mg) was infused slowly at least 30 min. BAI (bronchial arterial infusion) chemotherapy was followed by BACE (Drug-eluting beads bronchial arterial chemoembolization); the CalliSpheres loaded with cis-platinum (30 mg) were infused into the tumor-feeding arteries until stasis or near-stasis of blood flow in the vessel was observed. primaryPurpose: TREATMENT masking: NONE count: 85 type: ESTIMATED name: BAI-BACE 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 General hospital status: RECRUITING city: Beijing state: Beijing zip: 100853 country: China name: Qunfang Zhou, MD role: CONTACT phone: 8619868000115 email: [email protected] name: Feng Duan, MD role: CONTACT phone: 8613910984586 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06377722 id: CABOPRE briefTitle: Cabozantinib Treatment Prior to Cytoreductive Nephrectomy in Patients With Advanced or Metastatic Renal Cells Cancer overallStatus: TERMINATED date: 2018-11-01 date: 2022-08-09 date: 2022-08-09 date: 2024-04-22 date: 2024-04-26 name: Fundacion Oncosur class: NETWORK briefSummary: Phase II, multicenter, national, uncontrolled, multicenter, uncontrolled, phase II clinical trial for the evaluation of cabozantinib treatment prior to cytoreductive nephrectomy in patients with advanced or metastatic renal cell cancer candidates for primary tumor cytoreductive nephrectomy (NC). conditions: Renal Cell Carcinoma Metastatic conditions: Renal Cell Carcinoma Stage IV conditions: Renal Cell Carcinoma Stage III studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ACTUAL name: Cabozantinib measure: Radiological response rate prior to cytoreductive nephrectomy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Central de Asturias city: Oviedo state: Asturias country: Spain lat: 43.36029 lon: -5.84476 facility: Institut Català d'Oncologia. Idibell city: L'Hospitalet de Llobregat state: Barcelona country: Spain lat: 41.35967 lon: 2.10028 facility: Hospital Universitario de Valdecilla city: Santander state: Cantabria country: Spain lat: 43.46472 lon: -3.80444 facility: Hospital Univeristario 12 de Octubre city: Madrid zip: 28041 country: Spain lat: 40.4165 lon: -3.70256 facility: Centro Oncológico Clara Campal - HM CIOCC city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario La Paz city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Ramón y Cajal city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Severo Ochoa city: Madrid country: Spain lat: 40.4165 lon: -3.70256 hasResults: False |
<|newrecord|> nctId: NCT06377709 id: 24CP001 briefTitle: A Mixed-methods Acceptability Study of ProACTive™ to Help Burns Patients Adjust to Changes to Appearance overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2024-12 date: 2024-04-22 date: 2024-04-24 name: Nottingham University Hospitals NHS Trust class: OTHER briefSummary: This mixed-methods acceptability study aims to investigate whether an early acceptance and commitment therapy (ACT) based intervention called ProACTive™, aimed at supporting burns patients' adjustment to a changed appearance and preventing distress, is acceptable. This will be measured by descriptive data, questionnaire data and semi-structured interviews. |
Preliminary data on the potential clinical effectiveness of the intervention will also be gathered. This will be measured by scores on standardised questionnaires. conditions: Burn Injuries conditions: Burns conditions: Emotional Distress conditions: Adjustment studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 15 type: ESTIMATED name: ProACTive™ measure: Body Esteem Scale for Adolescents and Adults - Appearance subscale (BESAA-A) measure: Positive and Negative Affect Schedule (PANAS-GEN) measure: Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT) measure: Self-Compassion Scale - Short Form (SCS-SF) measure: Helpful Aspects of Therapy Form (HAT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06377696 id: MC230713 id: NCI-2024-02980 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: MC230713 type: OTHER domain: Mayo Clinic in Rochester id: 23-005512 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: Remote Cognitive Assessment Battery and Wearable Device Monitoring Platform While Assessing the Impact of Metformin in Patients With History of Cranial Radiation Therapy overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-30 date: 2027-04-30 date: 2024-04-22 date: 2024-04-26 name: Mayo Clinic class: OTHER briefSummary: This phase III trial evaluates whether patient care can be done remotely for patients having cranial (skull) radiation or who have previously had cranial radiation. In addition, this trial compares study outcomes between patients who get metformin and those who do not. Cranial radiation, an essential component of brain tumor treatment, can result in significant negative effects on cognitive (the ability to clearly think, learn, and remember) function. Wearable devices have been used in the field of neurology for seizure detection and assessment of patients with movement disorders. Wearable device technology has also been implemented for remote monitoring of cancer patients and for cancer clinical trials. Metformin is the active ingredient in a drug used to treat type 2 diabetes mellitus (a condition in which the body cannot control the level of sugar in the blood). It is also being studied in the treatment of cancer. Use of metformin may reduce risk of cognitive decline following radiation therapy within the skull (intracranial). These effects may be further strengthen by addition of device-based physical activity promotion. Mayo Test Drive is a web-based platform for remote self-administered cognitive assessment. Using Mayo Test Drive may help determine whether patient care can be done remotely, while simultaneously evaluating benefits of health promotion through use of a wearable watch device and metformin in preventing radiation-related cognitive decline. conditions: Malignant Brain Neoplasm studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 100 type: ESTIMATED name: Best Practice name: Medical Device Usage and Evaluation name: Metformin name: Neurocognitive Assessment name: Questionnaire Administration measure: Compliance of patients who complete the testing schedule for the cognitive assessments (Feasibility) measure: Overall completion rates and compliance (Feasibility) measure: Overall satisfaction measure: Adherence (Feasibility) measure: Neurocognitive scores measure: Incidence of adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: [email protected] name: Ugur T. Sener, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False |
<|newrecord|> nctId: NCT06377683 id: XMYY-2023KY122 briefTitle: Clinical Evaluation of 177Lu-DansyI-PSMA (LNC1011) in Patients With Metastatic Castration-Resistant Prostate Cancer overallStatus: RECRUITING date: 2024-04-05 date: 2025-12-30 date: 2026-12-30 date: 2024-04-22 date: 2024-04-22 name: The First Affiliated Hospital of Xiamen University class: OTHER briefSummary: Ten to 20% of patients with prostate cancer (PC) experience progression in their disease, even after undergoing pharmaceutical or surgical castration, leading to metastatic CRPC (mCRPC). Prostate-specific membrane antigen (PSMA) is a membrane-bound glycoprotein mostly specific to the prostate. While PSMA is expressed at low levels in normal prostate, this expression increased by 100-1000-fold in PC, which makes it a favorable target for therapy. This study was designed to evaluate the safety, tolerability, and maximum tolerated dose of a long-lasting radiolabeled ligand 177Lu-Dansyl-PSMA in mCRPC patients. conditions: Metastatic Castration-resistant Prostate Cancer, mCRPC studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: classic 3+3 dose escalation primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: 177Lu-Dansyl-PSMA radioligand therapy measure: Incidence of treatment-related adverse events (safety and tolerability) measure: To determine the maximum tolerated dose (MTD) measure: Dosimetry sex: MALE minimumAge: 21 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, MD, PhD 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: NCT06377670 id: 38RC24.0012 briefTitle: Study of Functional and Aesthetic Outcomes After Wassel IV Thumb Duplication Surgery in Pediatric Population, With a Follow-up of at Least One Year overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-05-06 date: 2024-05-15 date: 2024-04-22 date: 2024-04-22 name: University Hospital, Grenoble class: OTHER briefSummary: The purpose of this study is to evaluate the functional and aesthetic outcomes in children with Wassel IV thumb duplication conditions: Wassel IV Thumb Duplication studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 30 type: ESTIMATED name: Wassel IV Thumb Duplication Surgery measure: Functional and Aesthetic Outcomes measure: Comparison of Surgical Techniques measure: Efficacy of Skin Flap Types measure: Immobilization Method Analysis measure: Preoperative Angle Decision Model sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06377657 id: DONT4GET briefTitle: Oxidative and Antioxidant Indices to HIIT and Aloe Vera Supplementation in Patients With T2DM overallStatus: COMPLETED date: 2022-01-15 date: 2023-06-21 date: 2024-02-19 date: 2024-04-22 date: 2024-04-22 name: University of Nis class: OTHER briefSummary: Diabetes is a prevalent metabolic disease that leads to increased blood sugar levels due to insulin shortage or resistance. Type 2 diabetes is often linked to obesity, which can increase insulin resistance. Meteorin-like protein (METRNL) is a new secreted protein that affects insulin sensitivity and has been found to be negatively related to serum glucose levels in people with diabetes. |
Oxidative stress in diabetics can stimulate the production of inflammatory mediators, increasing the activity of the antioxidant system. Aloe vera, a widely used plant, has been used for treating diabetes, wound healing, tumors, and inflammatory bowel disease. It has anti-inflammatory, antioxidant, neuroprotective, antidepressant, and memory-enhancing effects. |
Exercise can improve diabetic patients' conditions by increasing the expression of GLUT4 protein and skeletal muscle. High-intensity interval training has been shown to increase the expression of the METORIN gene in human subjects and decrease MDA in type 2 diabetic patients. However, no studies have examined the simultaneous effect of exercise and Aloe vera on diabetes indicators. |
The present study aims to investigate the response of METRNL and some oxidative and antioxidant plasma indicators to high-intensity interval training and Aloe vera supplementation in type 2 diabetic men. The findings indicate that exercise and consumption of plants with anti-inflammatory and antioxidant properties can be effective in modulating the pathological effects of diabetes and increasing insulin sensitivity. conditions: Diabetes Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The participants were blinded for the supplementation. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 44 type: ACTUAL name: Exercise name: Aloe vera measure: METRNL - Meteorin Like, Glial Cell Differentiation Regulator measure: Glutathione peroxidase (GPx) measure: Serum superoxide dismutase (SOD) measure: Total antioxidant blood capacity (TAD) measure: Plasma malondialdehyde (MDA) sex: MALE minimumAge: 25 Years maximumAge: 40 Years stdAges: ADULT facility: Department of Sport Physiology, Faculty of Sport and Physical education, Islamic Azad University of Ayatollah Amoli, Amol, Iran city: Amol country: Iran, Islamic Republic of lat: 36.46961 lon: 52.35072 hasResults: False |
<|newrecord|> nctId: NCT06377644 id: DPT/Batch-Fall19/560 briefTitle: Comparing the Efficacy of KT vs DN With Conventional Treatment for Improving QOL and Alleviating Pain in Frozen Shoulder overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-01 date: 2024-05-01 date: 2024-07-05 date: 2024-04-22 date: 2024-04-22 name: Superior University class: OTHER briefSummary: "Randomized control trial is our study design, we will make 2 groups group A ( 15 patients of frozen shoulder) and Group B (15 patients of frozen shoulder). we will apply interventions by this way For group A KT (kinesiology taping) will be applied on frozen shoulder patients by a professional physiotherapist or certified physiotherapist according to their pain pattern in muscles (supraspinatus, infraspinatus, teres minor, deltoid, subscapularis) with conventional physiotherapy of frozen shoulder also continues on 15 patients (group A). KT will apply twice a week for 8 weeks. We can check the results of our intervention every week by using variable tools or outcome measures, measuring pain by VAD (visual analog scale) and quality of life in the frozen shoulder by SPADI (shoulder pain and disability index) every week. And for group B Dry needling with conventional physical therapy. conditions: Frozen Shoulder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ACTUAL name: Kinesio taping name: Dry Needling measure: VAS measure: SPADI sex: ALL minimumAge: 35 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pain away Physical Therapy city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False |
<|newrecord|> nctId: NCT06377631 id: FATHIS+ briefTitle: Effect of Multi-ingredient on Visceral Adiposity & Non-alcoholic Fatty Liver Disease in Postmenopausal Women With Abdominal Obesity acronym: FATHIS+ overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-22 date: 2024-04-25 name: Fundació Eurecat class: OTHER name: Centre de Diagnosi per la Imatge name: Instituto de Investigación Biomédica de Girona (IDIBGI) name: Laboratorio de Referencia de Cataluña briefSummary: This study aims to evaluate the effect of daily intake of a specific combination of different natural histidine-related amino acids in combination with dietary recommendations, in the reduction of visceral fat, as well as their associated comorbidities, in postmenopausal women with abdominal obesity. conditions: Visceral Obesity conditions: Non-alcoholic Fatty Liver conditions: Postmenopausal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Multi-ingredient of L-histidine, L-serine, L-carnosine and N-Acetylcysteine name: Placebo measure: Change in Visceral Adiposity measure: Height (cm) measure: Age measure: Ethnicity measure: Change in Body Weight (kg) measure: Change in Body Mass Index (BMI) (Kg/m^2) measure: Change in Neck circumference (cm) measure: Change in Arm circumference (cm) measure: Change in Waist circumference (cm) measure: Change in Hip circumference (cm) measure: Change in Conicity Index measure: Change in Waist-to-Hip ratio measure: Change in Lipid Accumulation Product (LAP) measure: Change in Systolic Blood Pressure (mm Hg) measure: Change in Diastolic Blood Pressure (mm Hg) measure: Change in heart rate (bpm) measure: Change in serum glucose levels (mg/dL) measure: Change in serum total cholesterol (mg/dL) measure: Change in serum high-density lipoprotein cholesterol (HDL-C,mg/dL) measure: Change in serum low-density lipoprotein cholesterol (LDL-C, mg/dL) measure: Change in serum triglycerides (TG, mg/dL) measure: Change in serum alanine aminotransferase (ALT, U/L) measure: Change in serum aspartate aminotransferase (AST, U/L) measure: Change in serum gamma glutamyl transferase (GGT, U/L) measure: Change in serum insulin levels (mU/L) measure: Change in serum leptin levels (pg/mL) measure: Change in serum adiponectin levels (ng/mL) measure: Change in Adiponectin/Leptin ratio (numerical ratio) measure: Change in serum Monocyte chemoattractant protein-1 (MCP-1) levels (pg/mL) measure: Change in plasma tumor necrosis factor alpha (TNF-alpha) levels (pg/mL) measure: Change in plasma Interleukin 6 (IL-6) levels (pg/mL) measure: Change in plasma Interleukin 10 (IL-10) levels (pg/mL) measure: Change in plasma Intercellular Adhesion Molecule 1 (ICAM-1) levels (ng/mL) measure: Change in plasma Cluster of Differentiation 14 (CD14) levels (pg/mL) measure: Change in plasma oxidized low density lipoproteins (LDLox) levels (mU/L) measure: Change in serum C-Reactive protein levels (mg/L) measure: Change in Histidine levels in blood (umol/L) measure: Change in Acylcarnitine levels in blood (umol/L) measure: Change in 17-beta-estradiol (E2) levels in blood (pg/mL) measure: Change in Follicle-stimulating hormone (FSH) levels in blood (mU/mL) measure: Change in Homeostatic Model Assessment from Insulin Resistance Index (HOMA-IR) measure: Change in Fatty Liver Index (FLI) measure: Change in Triglyceride glucose index (TyG) measure: Change in Plasma atherogenic index measure: Change in lipidomic profile measure: Change in intestinal microbiota composition measure: Change in the expression of lipid-metabolism genes in PBMC measure: Change in Dietary habits measure: Change in Physical activity measure: Concomitant medication measure: Consumption of dietary supplements measure: Change in the Supraclavicular skin temperature measure: Change in postmenopausal symptoms measure: Adverse events sex: FEMALE minimumAge: 50 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anna Crescenti city: Reus state: Catalonia. Spain zip: 43204 country: Spain name: Anna Crescenti, PhD role: CONTACT phone: 977770958 email: [email protected] lat: 41.15612 lon: 1.10687 hasResults: False |
<|newrecord|> nctId: NCT06377618 id: DPT/Batch-Fall19/556 briefTitle: Comparison Of Resistance Training And Core Strengthening Exercises Vitamin D In Postmenopausal Women With Low Back Pain overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-15 date: 2024-05-20 date: 2024-06-20 date: 2024-04-22 date: 2024-04-22 name: Superior University class: OTHER briefSummary: This study aims to evaluate the effectiveness of resistance training, core strengthening exercises, and vitamin D supplementation in reducing low back pain (LBP) among postmenopausal women. conditions: Menopausal conditions: Pain, Low Back studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 36 type: ACTUAL name: Resistance Training and Core Strengthening Exercises Group name: Resistance Training and Core Strengthening Exercises Group Plus Vitamin D Supplementation measure: Visual Analog Scale (VAS) measure: Oswestry Disability Index (ODI) sex: FEMALE minimumAge: 50 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azra Naheed Medical College, Superior University city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False |
<|newrecord|> nctId: NCT06377605 id: MD-15-2024 briefTitle: The Efficacy of Thoracic Erector Spinae Plane Block For Perioperative Analgesia in Laparoscopic Bariatric Surgery for Super Obese Patients: Randomized Controlled Trial. overallStatus: RECRUITING date: 2023-03-10 date: 2024-06-30 date: 2024-08-30 date: 2024-04-22 date: 2024-04-22 name: Amany Ahmed Eissa class: OTHER briefSummary: The epidemic of overweight and obesity presents a major challenge to chronic disease prevention and health across the life course around the world. \[1\] Bariatric surgery has proved to be an efficient intervention in the management of obesity. As a result, the number of post-bariatric surgery patients in the population is growing \[2\]. |
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