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<\|newrecord\|> nctId: NCT06300281 id: NEAEGeriatircs briefTitle: Comparison of Neuromuscular and Aquatic Exercise Programs on Fall Risk and Physical Function in Geriatrics acronym: NE-AEinGR overallStatus: NOT_YET_RECRUITING date: 2024-05-04 date: 2024-06-15 date: 2024-10-30 date: 2024-03-08 date: 2024-03-08 name: Alanya Alaaddin Keykubat University class: OTHER name: Pamukkale University briefSummary: Objective: The aim of this study is to compare neuromuscular and aquatic Exercise programs on fall risk and physical function in geriatrics.
Methods: As a result of the power analysis (G-Power), 36 participants are planned to be included in this study Block randomization will be used to divide participants into 2 groups, each with at least 18 participants: Group 1 (NE Group) and Group 2 (AE Group) (Randomizer.org). NE (Neuromuscular Exercise) group will participate in a 12-week exercise program consisting of sensorimotor system training, postural stability and control, global and local joint stabilization, balance training, muscle strength, breathing, and functional movement patterns.AE (Aqıuatic Exercise) Group will participate in an aquatic exercise program, which includes warm-up, mobility and strength, stretching, and cooling exercises in a 140 cm deep pool with a water temperature of 32 °. Data will be collected using the International Physical Activity Survey Short Form (IPAQ-SF), Montreal Cognitive Assessment Scale (MoCA), Geriatric Pain Measure, Optojump-next (Microgate, Bolzano, Italy), 6-minute Walk Test, 30-second-Sit-to-Stand Test, Four Step Square Test, Berg Balance Scale, Fear of Falling Avoidance Behavior Questionnaire.
Practice Implications: This current study will contribute to the understanding of how neuromuscular exercises affect falls and physical function in geriatrics. conditions: Geriatrics conditions: Exercise Therapy conditions: Fall conditions: Physical Functional Performance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will be divided into two parallel groups: The neuromuscular exercise group and the Aquatic exercise group. Both groups will participate in exercise programs for 12 weeks. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 36 type: ESTIMATED name: Neuromuscular Exercise name: Aquatic Exercise measure: Change in Pain measure: Change in walking and reaction time measure: Change in aerobic capacity measure: Change in muscular fitness measure: Change in s balance measure: Change in dynamic balance measure: Change in fear of falling measure: Physical activity level measure: Level of cognition sex: ALL minimumAge: 65 Years maximumAge: 85 Years stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06300268 id: CSPL/PL/2023/004 briefTitle: Advapro Coronary Stent System in Coronary Artery Diseased Patients. acronym: RESTORE overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-12 date: 2024-03-08 date: 2024-03-08 name: Advanced MedTech Solutions Pvt. Ltd. class: OTHER briefSummary: A Prospective, Multicentre, Pilot Study to Evaluate the Safety and Performance of the AdvaPro Sirolimus Eluting Coronary Stent System in Coronary Artery Stenosis in Indian and European Population.
To evaluate the performance of AdvaPro Sirolimus Eluting Stent follow up indicated by MACE at 9 months.
Of the 120, 40 patients will be assigned to European population and 80 patients will be assigned to Indian population. QCA is applicable for only in sub-strategy participants at baseline and 9 month follow-up visit.
A QCA Analysis will be performed on minimum 48 patients in Indian population only.
Interval(Days) for patients visit at Day 0, Day 30±6, Day 180±8, Day 270±10 and Day 360±14. conditions: Coronary Artery Disease conditions: De Novo Stenosis Lesion conditions: Coronary Stent Implantation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pilot Study (Open Label) primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: AdvaPro Sirolimus Eluting Coronary Stent System measure: Composite Endpoint measure: Incidence of DOCE measure: Incidence of POCE measure: Incidence of MACE measure: Target vessel failure (TVF) measure: Non-Target Vessel related Myocardial Infarction measure: Stent thrombosis measure: Device success measure: Procedural Success measure: Acute Device Success measure: For QCA Group measure: For QCA Group measure: For QCA Group sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06300255 id: IRB 00166616 briefTitle: Evaluation of the H.O.O.V.E.S. Healing Intensives Program overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2029-02-01 date: 2029-02-01 date: 2024-03-08 date: 2024-03-08 name: VA Salt Lake City Health Care System class: FED briefSummary: The aim of this study is to measure the impact of these H.O.O.V.E.S. healing intensives on Veteran participants using several psychological instruments. The investigators are planning to administer the demographic questionnaires and psychological instruments to Veteran participants before the healing intensives. Psychological instruments will be administered immediately pre-intervention, pre- and post-session for each session, post-intervention, 90, 120 and 360 days post-intervention. The primary aim is to assess for statistically significant changes pre- to post session and pre- to post-intervention. conditions: Anxiety conditions: PTSD conditions: Depression studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: H.O.O.V.E.S. Healing Intensives measure: Mean Difference in AAQII pre- to post-session and pre- to post-intervention measure: Mean Difference in PANAS pre- to post-session and pre- to post-intervention measure: Mean Difference in STAI pre- to post-session and pre- to post-intervention measure: Mean Difference in PCL pre- to post-session and pre- to post-intervention measure: Mean Difference in BDI pre- to post-session and pre- to post-intervention measure: Mean Difference in PTGI pre- to post-session and pre- to post-intervention measure: Mean Difference in B-SCS pre- to post-session and pre- to post-intervention measure: Mean Difference in AAQII pre- to post-session measure: Mean Difference in PANAS pre- to post-session measure: Mean Difference in STAI pre- to post-session sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: George E. Wahlen Department of Veterans Affairs Medical Center city: Salt Lake City state: Utah zip: 84148 country: United States lat: 40.76078 lon: -111.89105 hasResults: False
<\|newrecord\|> nctId: NCT06300242 id: UP-23-00859 briefTitle: Incentives for Influenza Vaccination overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-17 date: 2024-01-24 date: 2024-02-29 date: 2024-03-08 date: 2024-03-08 name: University of Southern California class: OTHER name: J-PAL North America briefSummary: In this work, we are assessing the impact of messaging with or without a $50 financial incentive on influenza vaccination rates in a county health system. Our main hypothesis is that a message with a $50 financial incentive will increase vaccination rates relative to a control/"treatment as usual" group. We further hypothesize that the financial incentive will increase vaccination rates relative to the message only arm. conditions: Influenza Vaccination studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 66000 type: ESTIMATED name: Reminders name: Financial Incentive name: Placebo measure: Vaccination status at 1 week measure: Vaccination status at 2 weeks measure: Vaccination status at 1 month sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Contra Costa Health Services city: Martinez state: California zip: 94553 country: United States lat: 38.01937 lon: -122.13413 hasResults: False
<\|newrecord\|> nctId: NCT06300229 id: 2023-508325-27-00 briefTitle: NAPO - Novel Approach for Oligospermia acronym: NAPO overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2025-12 date: 2024-03-08 date: 2024-03-13 name: Martin Blomberg Jensen class: OTHER briefSummary: This randomized controlled trial aims to assess whether treatment with denosumab can improve semen quality in infertile men selected by serum anti-mullerian hormone (AMH) as a positive predictive biomarker, and with severely impaired semen quality (concentrations between 0.01 million/mL to 2 million/mL). conditions: Infertility, Male studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: Denosumab name: sodium chloride measure: The difference in sperm concentration (million pr. mL) on day 80 measure: The difference in semen quality (total sperm count, motile sperm, progressive motile sperm and morphologically normal sperm) between baseline and two semen samples delivered at day 80 and day 83 after inclusion measure: The change/differences in number of pregnancies achieved before day 180 measure: The difference in the number of miscarriages throughout the trial before day 180 measure: The change/difference in serum levels of follicle stimulating hormone (FSH) on day 80 measure: The change/difference in serum levels of reproductive hormone luteinizing hormone (LH) on day 80 measure: The change/difference in serum levels of reproductive hormone AMH on day 80 measure: The change/difference in serum levels of reproductive hormone Inhibin B on day 80 measure: The change/difference in CatSper expression on day 80 measure: The change/difference in RANKL expression on day 80 sex: MALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Division of Translational Endocrinology, Department of Endocrinology and Internal Medicine city: Copenhagen country: Denmark name: Sam Kafai Yahyavi, MD role: CONTACT phone: +45 35456360 email: sam.kafai.yahyavi.01@regionh.dk name: Mads Joon Jorsal, MD role: CONTACT phone: +45 38683868 email: mads.joon.jorsal@regionh.dk name: Sam Kafai Yahyavi, MD role: PRINCIPAL_INVESTIGATOR name: Mads Joon Jorsal, MD role: SUB_INVESTIGATOR lat: 55.67594 lon: 12.56553 hasResults: False
<\|newrecord\|> nctId: NCT06300216 id: KYLL-202401-034-1 briefTitle: A Real-world Study of Octreotide Microspheres in Chinese Patients With Neuroendocrine Tumors overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2027-11-26 date: 2028-05-26 date: 2024-03-08 date: 2024-03-08 name: Qilu Hospital of Shandong University class: OTHER briefSummary: The aim of this multicenter, open-label, observational study is to evaluate the safety and efficacy of octreotide microspheres in the treatment of advanced neuroendocrine tumors in real clinical practice, especially to evaluate the treatment of octreotide microspheres in various subgroups of neuroendocrine tumor patients. conditions: Neuroendocrine Tumors studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Octreotide microspheres measure: Treatment Emergent Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Qilu hospital of Shandong University city: Jinan state: Shandong zip: 250012 country: China name: Jian Wang, Dr. role: CONTACT phone: 8618560088226 email: wang.jian@sdu.edu.cn lat: 36.66833 lon: 116.99722 hasResults: False
<\|newrecord\|> nctId: NCT06300203 id: CM310_IIS_SAR07 briefTitle: Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis acronym: MEGREZ overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2025-05-30 date: 2025-05-30 date: 2024-03-08 date: 2024-03-08 name: Beijing Tongren Hospital class: OTHER briefSummary: Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease. conditions: Seasonal Allergic Rhinitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Interleukin-4 receptor responders name: Placebo measure: Average change from baseline in daily retrospective total nasal symptom score (rTNSS) at week 2. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tongren Hospital, Capital Medical University city: Beijing state: Beijing zip: 100000 country: China lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06300190 id: Treatment SLAP type IV lesion briefTitle: Biceps Tenodesis Alone Versus Biceps Tenodesis and Labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion Type IV overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-06 date: 2025-07 date: 2024-03-08 date: 2024-03-12 name: Assiut University class: OTHER briefSummary: Aim of this study is comparing results Biceps Tenodesis Alone Versus Biceps Tenodesis and labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion Type IV conditions: SLAP Lesion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2 parallel groups selected by Randomisation primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Aim of this study is comparing outcome results of Biceps Tenodesis Alone Versus Biceps Tenodesis and labrum Repair in Superior Labrum Anteroposterior (SLAP) Lesion Type IV whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Biceps tenodesis alone name: Biceps tenodesis and labrum repair measure: Clinical outcome by American shoulder elbow score sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06300177 id: D1553-III-01 briefTitle: D-1553 Tablet Versus Docetaxel Injection for KRAS G12C Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer After Prior Standard Therapy Failure overallStatus: RECRUITING date: 2024-03-28 date: 2026-10 date: 2027-12 date: 2024-03-08 date: 2024-04-26 name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: The purpose of this project is to evaluate progression-free survival (PFS) of D-1553 Tablet versus Docetaxel Injection in subjects with prior standard therapy failure kirsten rat sarcoma viral oncogene (KRAS) G12C mutation positive locally advanced or metastatic non small cell lung cancer (NSCLC), progression-free survival (PFS) as assessed by the Independent Review Committee (IRC) based on RECIST 1.1 was used as the primary endpoint. conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 522 type: ESTIMATED name: D-1553 Tablet name: Docetaxel injection measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Objective mitigation rate (ORR) measure: Duration of Response (DOR) measure: Disease control rate (DCR) measure: Time to response (TTR) measure: Patient-reported outcome (PRO) measure: Abnormal laboratory test indicators measure: Adverse event rate measure: Time to Maximum Plasma Concentration (Tmax) measure: Half life (t1/2) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Province Hospital status: NOT_YET_RECRUITING city: Hefei state: Anhui zip: 230002 country: China name: Minghong Bao, Master role: CONTACT phone: 15255187155 email: baomh2015@163.com lat: 31.86389 lon: 117.28083 facility: Cancer Hospital Chinese Academy of Medical Sciences status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100021 country: China name: Yan Wang, Doctor role: CONTACT phone: 13911793771 email: wangyanyifu@163.com lat: 39.9075 lon: 116.39723 facility: Xuanwu Hospital Capital Medical University status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100053 country: China name: Yi Zhang, Doctor role: CONTACT phone: 13141370703 email: steven9130@sina.com lat: 39.9075 lon: 116.39723 facility: Beijing Cancer Hospital status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100142 country: China name: Jian Fang, Bachelor role: CONTACT phone: 13701224460 email: fangjian5555@yeah.net lat: 39.9075 lon: 116.39723 facility: Peking University Third Hospital status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Baoshan Cao, Doctor role: CONTACT phone: 13641093518 email: caobaoshan0711@aliyun.com lat: 39.9075 lon: 116.39723 facility: Beijing Chest Hospital,Capital Medical University status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 101149 country: China name: Tongmei Zhang, Doctor role: CONTACT phone: 13683016715 email: tongmeibj@163.com lat: 39.9075 lon: 116.39723 facility: The Fifth medical center of Chinese PLA General Hospital status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 222002 country: China name: Junxun Ma, Doctor role: CONTACT phone: 13699262799 email: majunxun74@126.com lat: 39.9075 lon: 116.39723 facility: The Second Affiliated Hospital of Chongqing Medical University status: NOT_YET_RECRUITING city: Chongqing state: Chongqing zip: 400010 country: China name: Zhenzhou Yang, Doctor role: CONTACT phone: 13883270881 email: yangzz1970@163.com lat: 29.56278 lon: 106.55278 facility: Chongqing Cancer Hospital status: NOT_YET_RECRUITING city: Chongqing state: Chongqing zip: 400032 country: China name: Jianlin Long, Doctor role: CONTACT phone: 17830326836 email: ga.longjianlin@163.com lat: 29.56278 lon: 106.55278 facility: The Southwest hospital of AMU status: NOT_YET_RECRUITING city: Chongqing state: Chongqing zip: 400038 country: China name: Jianjun Li, Doctor role: CONTACT phone: 13608319428 email: leejjun2007@163.com lat: 29.56278 lon: 106.55278 facility: Army Medical Center status: NOT_YET_RECRUITING city: Chongqing state: Chongqing zip: 400042 country: China name: Mengxia Li, Doctor role: CONTACT phone: 18580408265 email: 707849603@qq.com lat: 29.56278 lon: 106.55278 facility: Chongqing University Three Gorges Hospital status: NOT_YET_RECRUITING city: Chongqing state: Chongqing zip: 404100 country: China name: Wei Wang, Master role: CONTACT phone: 13635324483 email: 19574605@qq.com lat: 29.56278 lon: 106.55278 facility: Fujian Medical University Union Hospital status: NOT_YET_RECRUITING city: Fuzhou state: Fujian zip: 350001 country: China name: Peifeng Hou, Doctor role: CONTACT phone: 13799987620 email: 717217167@qq.com lat: 26.06139 lon: 119.30611 facility: The First Affiliated Hospital Of Fujian Medical University status: NOT_YET_RECRUITING city: Fuzhou state: Fujian zip: 350005 country: China name: Rixiong Wang, Doctor role: CONTACT phone: 13960758357 email: 13960758357@163.com lat: 26.06139 lon: 119.30611 facility: Fujian Cancer Hospital status: NOT_YET_RECRUITING city: Fuzhou state: Fujian zip: 350500 country: China name: Jing Zhang, Master role: CONTACT phone: 13809557405 email: cfcy813@sina.com lat: 26.06139 lon: 119.30611 facility: The First Affiliated Hospital of Xiamen University status: NOT_YET_RECRUITING city: Xiamen state: Fujian zip: 361003 country: China name: Feng Ye, Doctor role: CONTACT phone: 13860458889 email: yefengdoctor@sina.com lat: 24.47979 lon: 118.08187 facility: Lanzhou University Second Hospital status: NOT_YET_RECRUITING city: Lanzhou state: Gansu zip: 730030 country: China name: Junnian Shi, Master role: CONTACT phone: 13919778675 email: ldeyyzbgs@lzu.edu.cn lat: 36.05701 lon: 103.83987 facility: Gansu Provincial Cancer Hospital status: NOT_YET_RECRUITING city: Lanzhou state: Gansu zip: 730050 country: China name: Xiting Liu, Bachelor role: CONTACT phone: 13893296929 email: LXT-0421@163.com lat: 36.05701 lon: 103.83987 facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510399 country: China name: Minghui Wang, Doctor role: CONTACT phone: 13826276828 email: wmingh@mail.sysu.edu.cn lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Guangdong Pharmaceutical University status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 528405 country: China name: Xintian Qin, Master role: CONTACT phone: 13660558820 email: xintianqin@126.com lat: 23.11667 lon: 113.25 facility: The Affiliated Hospital of Guangdong Medical University status: NOT_YET_RECRUITING city: Zhanjiang state: Guangdong zip: 524001 country: China name: Shujun Li, Master role: CONTACT phone: 13726913133 email: lishujun072@163.com lat: 21.28145 lon: 110.34271 facility: The Second Affiliated Hospital of Guilin Medical College status: NOT_YET_RECRUITING city: Guilin state: Guangxi zip: 541199 country: China name: Bihui Li, Master role: CONTACT phone: 18378316283 email: lbihui0202@163.com lat: 25.28194 lon: 110.28639 facility: The First Affiliated Hospital of Guangxi Medical University status: NOT_YET_RECRUITING city: Nanning state: Guangxi zip: 530020 country: China name: Qing Bu, Doctor role: CONTACT phone: 18277133566 email: 1332271797@qq.com lat: 22.81667 lon: 108.31667 facility: Yulin First People's Hospital status: NOT_YET_RECRUITING city: Yulin state: Guangxi zip: 537000 country: China name: Haizhen Yi, Master role: CONTACT phone: 15807851995 email: yhz228815@168.com lat: 22.63333 lon: 110.15 facility: Guizhou Provincial People's Hospital status: NOT_YET_RECRUITING city: Guiyang state: Guizhou zip: 550002 country: China name: Yu Zhang, Doctor role: CONTACT phone: 18885146684 email: 248634489@qq.com lat: 26.58333 lon: 106.71667 facility: The Second Affiliated Hospital of Zunyi Medical University status: NOT_YET_RECRUITING city: Zunyi state: Guizhou zip: 563000 country: China name: Yuju Bai, Master role: CONTACT phone: 13984535566 email: byj6618@163.com lat: 27.68667 lon: 106.90722 facility: Hainan Provincial People's Hospital status: NOT_YET_RECRUITING city: Haikou state: Hainan zip: 570311 country: China name: Yongxing Chen, Master role: CONTACT phone: 13876825536 email: chen13876825536@163.com lat: 20.04583 lon: 110.34167 facility: Affiliated Hospital of Hebei University status: NOT_YET_RECRUITING city: Baoding state: Hebei zip: 050031 country: China name: Zizheng Song, Master role: CONTACT phone: 13932268911 email: 13932268911@163.com lat: 38.85111 lon: 115.49028 facility: The Affiliated Hospital of Chengde Medical College status: NOT_YET_RECRUITING city: Chengde state: Hebei zip: 067028 country: China name: Qingshan Li, Bachelor role: CONTACT phone: 15633142750 email: libing200865@126.com lat: 40.9519 lon: 117.95883 facility: The Fourth Hospital of Hebei Medical University status: NOT_YET_RECRUITING city: Shijiazhuang state: Hebei zip: 050011 country: China name: Yudong Wang, Doctor role: CONTACT phone: 15931166600 email: wyd_999@hebmu.edu.cn lat: 38.04139 lon: 114.47861 facility: Tangshan People's Hospital status: NOT_YET_RECRUITING city: Tangshan state: Hebei zip: 063001 country: China name: Junquan Yang, Doctor role: CONTACT phone: 19131829092 email: 13313059092@163.com lat: 39.63333 lon: 118.18333 facility: Affiliated Cancer Hospital of Harbin Medical University status: NOT_YET_RECRUITING city: Harbin state: Heilongjiang zip: 150000 country: China name: Baogang Liu, Doctor role: CONTACT phone: 13804552752 email: liubaogang1962@sina.com lat: 45.75 lon: 126.65 facility: The Second Affiliated Hospital of Harbin Medical University status: NOT_YET_RECRUITING city: Harbin state: Heilongjiang zip: 150000 country: China name: Tao Xin, Doctor role: CONTACT phone: 13633655999 email: xintao1234@263.net lat: 45.75 lon: 126.65 facility: Jiamusi Tuberculosis Hospital(Jiamusi Cancer Hospital) status: NOT_YET_RECRUITING city: Jiamusi state: Heilongjiang zip: 154000 country: China name: Hongmei Sun, Bachelor role: CONTACT phone: 15344540000 email: SHM1357@163.com lat: 46.79927 lon: 130.31633 facility: Anyang Tumor Hospital status: NOT_YET_RECRUITING city: Anyang state: Henan zip: 455001 country: China name: Yuanyuan Ji, Master role: CONTACT phone: 13460856657 email: jiyuanyuan666@126.com lat: 36.096 lon: 114.38278 facility: The First Affiliated Hospital of Henan University of Science and Technology status: NOT_YET_RECRUITING city: Luoyang state: Henan zip: 471003 country: China name: Zhiye Zhang, Master role: CONTACT phone: 13783100985 email: 13783100985@163.com lat: 34.68361 lon: 112.45361 facility: Nanyang second general hospital status: NOT_YET_RECRUITING city: Nanyang state: Henan zip: 473000 country: China name: Qichuan Wang, Master role: CONTACT phone: 13838709208 email: chuan12616@126.com lat: 32.99472 lon: 112.53278 facility: The First affiliated Hospital of Nanyang Medical College status: NOT_YET_RECRUITING city: Nanyang state: Henan zip: 473007 country: China name: Peng Cheng, Master role: CONTACT phone: 13782042723 email: oncologist@163.com lat: 32.99472 lon: 112.53278 facility: The First Affiliated Hospital Of Xinxiang Medical Unerversity status: NOT_YET_RECRUITING city: Xinxiang state: Henan zip: 453100 country: China name: Weiwei Li, Master role: CONTACT phone: 13837384916 email: 13837384916@163.com lat: 35.19033 lon: 113.80151 facility: Xuchang Central Hospital status: NOT_YET_RECRUITING city: Xuchang state: Henan zip: 461000 country: China name: Pengyuan Wang, Master role: CONTACT phone: 13837440693 email: wangpengyuan@126.com lat: 34.03189 lon: 113.86299 facility: Henan Cancer Hospital status: NOT_YET_RECRUITING city: Zhengzhou state: Henan zip: 450008 country: China name: Yanqiu Zhao, Master role: CONTACT phone: 13938252350 email: 13938252350@163.com lat: 34.75778 lon: 113.64861 facility: The First Affiliated Hospital Zhejiang University School of Medicine status: NOT_YET_RECRUITING city: Zhengzhou state: Henan zip: 450052 country: China name: Xingya Li, Doctor role: CONTACT phone: 13838253946 email: lixingyavip@163.com lat: 34.75778 lon: 113.64861 facility: Henan Provincial People's Hospita status: NOT_YET_RECRUITING city: Zhengzhou state: Henan zip: 463599 country: China name: Shundong Cang, Doctor role: CONTACT phone: 13592675836 email: cangshundong@163.com lat: 34.75778 lon: 113.64861 facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology status: NOT_YET_RECRUITING city: Wuhan state: Hubei zip: 430030 country: China name: Qian Chu, Doctor role: CONTACT phone: 13212760751 email: qianchu@tjh.tjmu.edu.cn lat: 30.58333 lon: 114.26667 facility: Zhongnan hospital of Wuhan University status: NOT_YET_RECRUITING city: Wuhan state: Hubei zip: 430071 country: China name: Junhong Zhang, Bachelor role: CONTACT phone: 13638679004 email: Zjhzhongnan@163.com lat: 30.58333 lon: 114.26667 facility: The Second Xiangya Hospital Of Central South University status: NOT_YET_RECRUITING city: Changsha state: Hunan zip: 410011 country: China name: Fang Ma, Doctor role: CONTACT phone: 13975806788 email: dr_fma@126.com lat: 28.19874 lon: 112.97087 facility: The Third Xiangya Hospital of Central South University status: NOT_YET_RECRUITING city: Changsha state: Hunan zip: 410013 country: China name: Xuewen Liu, Doctor role: CONTACT phone: 18711033808 email: aveinliu@163.com lat: 28.19874 lon: 112.97087 facility: Hunan Cancer Hospital status: NOT_YET_RECRUITING city: Changsha state: Hunan zip: 410031 country: China name: Bolin Chen, Doctor role: CONTACT phone: 13787101898 email: chenbolin@hnca.org.cn lat: 28.19874 lon: 112.97087 facility: Hunan Cancer Hospital status: NOT_YET_RECRUITING city: Changsha state: Hunan zip: 410031 country: China name: Yongzhong Luo, Bachelor role: CONTACT phone: 13607443876 email: luoyongzhong@hnca.org.cn lat: 28.19874 lon: 112.97087 facility: Xiangya Hospital Central South University status: NOT_YET_RECRUITING city: Changsha state: Hunan zip: 410119 country: China name: Rongrong Zhou, Doctor role: CONTACT phone: 13875898127 email: 664990095@qq.com lat: 28.19874 lon: 112.97087 facility: The first people's hospital of Changzhou status: NOT_YET_RECRUITING city: Changzhou state: Jiangsu zip: 213004 country: China name: Mei Ji, Doctor role: CONTACT phone: 0519-68871123 email: jimei@163.com lat: 31.77359 lon: 119.95401 facility: General Hospital of eastern theater command status: NOT_YET_RECRUITING city: Nanjing state: Jiangsu zip: 210007 country: China name: Yong Song, Doctor role: CONTACT phone: 13851761392 email: song_yong6310@126.com lat: 32.06167 lon: 118.77778 facility: Jiangsu Cancer Hospital status: NOT_YET_RECRUITING city: Nanjing state: Jiangsu zip: 210009 country: China name: Guohao Xia, Doctor role: CONTACT phone: 13913976000 email: 13913976000@163.com lat: 32.06167 lon: 118.77778 facility: Nantong Tumor Hospital status: NOT_YET_RECRUITING city: Nantong state: Jiangsu zip: 226006 country: China name: Junguo Liu, Bachelor role: CONTACT phone: 13814603295 email: jsntzlyy@126.com lat: 32.03028 lon: 120.87472 facility: Wuxi People's Hospital status: NOT_YET_RECRUITING city: Wuxi state: Jiangsu zip: 214023 country: China name: Tao Bian, Doctor role: CONTACT phone: 13358119859 email: biantaophd@126.com lat: 31.56887 lon: 120.28857 facility: Jiangyin People's Hospital status: NOT_YET_RECRUITING city: Wuxi state: Jiangsu zip: 214400 country: China name: Dong Shen, Doctor role: CONTACT phone: 15961663515 email: shendong@ntu.edu.cn lat: 31.56887 lon: 120.28857 facility: The Affiliated Hospital Of XuZhou Medical University status: NOT_YET_RECRUITING city: Xuzhou state: Jiangsu zip: 221004 country: China name: Zhengxiang Han, Doctor role: CONTACT phone: 18052268612 email: cnhzxyq@163.com lat: 34.18045 lon: 117.15707 facility: Xuzhou Central Hospital status: NOT_YET_RECRUITING city: Xuzhou state: Jiangsu zip: 221009 country: China name: Xiang Wang, Master role: CONTACT phone: 18912007930 email: wangxiang7726@163.com lat: 34.18045 lon: 117.15707 facility: Jiangxi Provincial People's Hospital status: NOT_YET_RECRUITING city: Nanchang state: Jiangxi zip: 330006 country: China name: Weirong Yao, Doctor role: CONTACT phone: 13907002901 email: 13907002901@126.com lat: 28.68396 lon: 115.85306 facility: The First Affiliated Hospital Of Nanchang University status: NOT_YET_RECRUITING city: Nanchang state: Jiangxi zip: 330006 country: China name: Longhua Sun, Doctor role: CONTACT phone: 18279110112 email: 48570887@qq.com lat: 28.68396 lon: 115.85306 facility: Jiangxi Cancer Hospital status: NOT_YET_RECRUITING city: Nanchang state: Jiangxi zip: 330029 country: China name: Zhenntian Liu, Master role: CONTACT phone: 15070083853 email: 345588506@qq.com lat: 28.68396 lon: 115.85306 facility: Jilin Cancer Hospital status: NOT_YET_RECRUITING city: Changchun state: Jilin zip: 130000 country: China name: Ying Cheng, Doctor role: CONTACT phone: 0431-80596003 email: jl.cheng@163.com lat: 43.88 lon: 125.32278 facility: The First Affiliated Hospital of China Medical University status: NOT_YET_RECRUITING city: Shenyang state: Liaoning zip: 110002 country: China name: Yunpeng Liu, Doctor role: CONTACT phone: 13898865122 email: cmu_trial@163.com lat: 41.79222 lon: 123.43278 facility: Shengjing hospital of China medical university status: NOT_YET_RECRUITING city: Shenyang state: Liaoning zip: 110022 country: China name: Caigang Liu, Doctor role: CONTACT phone: 18940254967 email: liucg@sj-hospital.org lat: 41.79222 lon: 123.43278 facility: Shandong Cancer Hospitai status: NOT_YET_RECRUITING city: Jinan state: Shandong zip: 250117 country: China name: Hui Zhu, Doctor role: CONTACT phone: 15805310022 email: drzhuhui@163.com lat: 36.66833 lon: 116.99722 facility: Jining First People's Hospital status: NOT_YET_RECRUITING city: Jining state: Shandong zip: 272011 country: China name: Jie Li, Doctor role: CONTACT phone: 13964921790 email: 13964921790@139.com lat: 35.405 lon: 116.58139 facility: Qingdao Municipal Hospital status: NOT_YET_RECRUITING city: Qingdao state: Shandong zip: 266011 country: China name: Mi Zhou, Master role: CONTACT phone: 18561858073 email: mi_zhou1978@163.com lat: 36.06488 lon: 120.38042 facility: The Second Affiliated Hospital of Shandong First Medical University status: NOT_YET_RECRUITING city: Tai'an state: Shandong zip: 271000 country: China name: Haiyan Liu, Master role: CONTACT phone: 18505387037 email: fylhy1998@163.com lat: 36.18528 lon: 117.12 facility: Weifang people's Hospital status: NOT_YET_RECRUITING city: Weifang state: Shandong zip: 261000 country: China name: Wei Tan, Master role: CONTACT phone: 13863659099 email: 13863659099@126.com lat: 36.71 lon: 119.10194 facility: Weihai Municipal Hospital status: NOT_YET_RECRUITING city: Weihai state: Shandong zip: 264299 country: China name: Fujun Yang, Doctor role: CONTACT phone: 18660377195 email: 58500775@qq.com lat: 37.50914 lon: 122.11356 facility: Ruijin Hospital, Shanghai Jiaotong University School Of Medicine status: NOT_YET_RECRUITING city: Shanghai state: Shanghai zip: 200025 country: China name: Min Zhou, Doctor role: CONTACT phone: 13681779624 email: doctor_zhou_99@163.com lat: 31.22222 lon: 121.45806 facility: Shanghai Chest Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200030 country: China name: Shun Lu, Doctor role: CONTACT phone: 13601813062 email: shun_lu@hotmail.com lat: 31.22222 lon: 121.45806 facility: Changzhi People's Hospital status: NOT_YET_RECRUITING city: Changzhi state: Shanxi zip: 046000 country: China name: Jun Zhao, Doctor role: CONTACT phone: 13835578500 email: zhaojun380@163.com name: Xianping Zhao, Bachelor role: CONTACT phone: 13453503966 email: ZXP13453503966@126.com lat: 35.20889 lon: 111.73861 facility: Shanxi Provincial Cancer Hospital status: NOT_YET_RECRUITING city: Taiyuan state: Shanxi zip: 030013 country: China name: Wei Guo, Master role: CONTACT phone: 13834563396 email: guowei812@126.com lat: 37.86944 lon: 112.56028 facility: The First Affiliated Hospital of Xi'An JiaoTong University status: NOT_YET_RECRUITING city: Xi'an state: Shanxi zip: 710061 country: China name: Xiaomin Dang, Doctor role: CONTACT phone: 18991232795 email: dxming112@163.com lat: 34.25833 lon: 108.92861 facility: The Second Affiliated Hospital of Air Force Medical University status: NOT_YET_RECRUITING city: Xian state: Shanxi zip: 710032 country: China name: Haichuan Su, Doctor role: CONTACT phone: 18629190366 email: cntdgcp@163.com lat: 34.25833 lon: 108.92861 facility: Sichuan Provincial People's Hospital status: NOT_YET_RECRUITING city: Chengdu state: Sichuan zip: 610072 country: China name: Haitao Lan, Doctor role: CONTACT phone: 18981838376 email: lanht@sina.com lat: 30.66667 lon: 104.06667 facility: The Affiliated Hospital Of Southwest Medical Unerversity status: NOT_YET_RECRUITING city: Luzhou state: Sichuan zip: 646000 country: China name: Peirong Ren, Master role: CONTACT phone: 15883037066 email: 1097802221@qq.com facility: Mianyang Central Hospital status: NOT_YET_RECRUITING city: Mianyang state: Sichuan zip: 621099 country: China name: Gang Feng, Doctor role: CONTACT phone: 18141380968 email: 15520828768@163.com lat: 31.46784 lon: 104.68168 facility: The second people's hospital of neijiang status: NOT_YET_RECRUITING city: Neijiang state: Sichuan zip: 641000 country: China name: Yu Liu, Master role: CONTACT phone: 13698308655 email: 13278258@qq.com lat: 29.58354 lon: 105.06216 facility: Tianjin medical University cancer status: NOT_YET_RECRUITING city: Tianjin state: Tianjin zip: 300181 country: China name: Xiubao Ren, Doctor role: CONTACT phone: 18622221235 email: rwziyi@163.com lat: 39.14222 lon: 117.17667 facility: The Affiliated Tumor Hospital of Xinjiang Medical University status: NOT_YET_RECRUITING city: Urumqi state: Xinjiang zip: 830054 country: China name: Chunling Liu, Master role: CONTACT phone: 13899931987 email: liudeyouxiang66@163.com lat: 43.80096 lon: 87.60046 facility: Yunnan Cancer Hospital status: NOT_YET_RECRUITING city: Kunming state: Yunnan zip: 650118 country: China name: Runxiang Yang, Master role: CONTACT phone: 13888876721 email: 13888876721@163.com lat: 25.03889 lon: 102.71833 facility: The First Affiliated Hospital Zhejiang University School of Medicine status: NOT_YET_RECRUITING city: Hangzhou state: Zhejiang zip: 310009 country: China name: Yina Wang, Doctor role: CONTACT phone: 15957109041 email: sinead555@163.com lat: 30.29365 lon: 120.16142 facility: The Second Affiliated Hospital Zhejiang University School of Medicine status: NOT_YET_RECRUITING city: Hangzhou state: Zhejiang zip: 310009 country: China name: Pingli Wang, Doctor role: CONTACT phone: 13516808409 email: W_pl77@163.com lat: 30.29365 lon: 120.16142 facility: The First Affiliated Hospital of Wenzhou Medical University status: NOT_YET_RECRUITING city: Wenzhou state: Zhejiang zip: 325000 country: China name: Yanfan Chen, Doctor role: CONTACT phone: 13600666600 email: chenyf2605@163.com lat: 27.99942 lon: 120.66682 hasResults: False
<\|newrecord\|> nctId: NCT06300164 id: Unripecarobinceliac briefTitle: The Effect of Unripe Carob Fruit in Celiac Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-01 date: 2024-07-01 date: 2024-03-08 date: 2024-03-08 name: Toros University class: OTHER briefSummary: The aim of this study was to investigate the effects of the consumption of cookies produced by adding the unripe part of carob fruit, which has high insoluble fiber, polyphenol and antioxidant content, on the oxidative parameters (TAS and MDA), intestinal permeability (zonulin, GIP) and microbiota of celiac patients and to develop new products containing unripe carob fruit for celiac patients in this direction. conditions: Celiac Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will conduct by using a prospective randomized double-blind clinical trial model. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Participants will not know which type of cookies to eat. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 30 type: ESTIMATED name: Unripre Carob measure: Examination of between group differences regarding serum Total Antioxidant Capacity (TAC) measure: Examination of between group differences regarding serum Malondialdehyde (MDA) measure: Examination of between group differences regarding serum zonulin measure: Comparison of between group differences regarding serum Total Antioxidant Capacity (TAC) measure: Comparison of between group differences regarding serum Malondialdehyde (MDA) measure: Comparison of between group differences regarding serum zonulin sex: ALL minimumAge: 19 Years maximumAge: 64 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06300151 id: Ultrasound Real-time Guidance briefTitle: The Effect of Ultrasound Real-time Guidance Technique on the Effectiveness and Safety of Labor Analgesia overallStatus: RECRUITING date: 2024-04-01 date: 2025-12-01 date: 2025-12-31 date: 2024-03-08 date: 2024-03-08 name: Zongxun Lin class: OTHER briefSummary: Ultrasound real-time guidance technology has great advantages over traditional blind exploration technology in terms of accuracy, success rate, and reduction of puncture damage in intervertebral space positioning through operational visualization, greatly improving the effectiveness and safety of spinal block. At present, Doppler ultrasound is rarely used for spinal block, especially for real-time ultrasound guidance technology, which has not been widely applied in clinical practice due to its high equipment requirements, lack of mature puncture plans, complex operation, and high learning curve. If a comprehensive diagnosis and treatment plan can be developed, it will greatly improve the delivery experience of mothers. conditions: Labor Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Ultrasound Real-time Guidance combined with Dural Puncture Epidural Labor Analgesia name: Dural Puncture Epidural Labor Analgesia measure: Analgesic effect（onset time） measure: Analgesic effect（block level） measure: Analgesic effect（block effect） measure: Analgesic effect（Visual Analogue Scale） measure: Analgesic effect（number of Patient controlled analgesia） measure: Analgesic effect（time of Patient controlled analgesia） measure: Uterine contraction indicators（Frequency） measure: Uterine contraction indicators（duration） measure: Uterine contraction indicators（Number of pregnant women with Tachysystole） measure: Uterine contraction indicators（Number of pregnant women with hypertonus） measure: Fetal heart indicators（Fetal heart rate） measure: Fetal heart indicators（NICHD classification） measure: Fetal heart indicators（Fetal Heart Rate decelerations） measure: Fetal heart indicators（Fetal Heart Rate Variability） measure: Apgar score measure: Sacral sensory block of pregnant women measure: modified bromage score measure: Operation evaluation（Time） measure: Operation evaluation（number of times） measure: Operation evaluation（side effects and Complications） measure: Delivery mode measure: Concentration of Interleukin 6 measure: Concentration of hypersensitive C-reactive protein measure: Concentration of cortisol measure: Maternal rehabilitation indicators（Postpartum hospital stay） measure: Maternal rehabilitation indicators（Edinburgh Postnatal Depression Scale） measure: Maternal rehabilitation indicators（Postoperative Recovery Quality Scale（QOR-40）） measure: Number of pregnant women with adjust the treatment plan and adjustment method measure: Drug consumption measure: Effect of stages of labor（time） measure: body temperature changes measure: Number of pregnant women with Infection during labor measure: Side effects and complications of labor analgesia measure: The reasons and number of pregnant women with conversion of natural labor to Caesarean section measure: Self-Rating Anxiety Scale measure: Delivery fear score（numerical rating scale） measure: Delivery satisfaction survey sex: FEMALE minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT facility: Fujian Provincial Hospital status: RECRUITING city: Fuzhou state: Fujian zip: 350001 country: China name: Zongxun Lin, Master role: CONTACT phone: +8613763820916 email: 13763820916@189.cn lat: 26.06139 lon: 119.30611 hasResults: False
<\|newrecord\|> nctId: NCT06300138 id: 2023-631-2 briefTitle: Antifungal Agents and Infrared Thermotherapy Alone or in Combination in the Treatment of Sporotrichosis overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-12 date: 2026-12 date: 2024-03-08 date: 2024-03-08 name: First Hospital of China Medical University class: OTHER briefSummary: Sporotrichosis is a chronic granulomatous mycosis caused by sporothrix complex. The course of sporotrichosis is always prolonged and even life-threatening, the treatment of this disease in an important scientific problem to be solved. The investigators previously found the predominance of subtype M2 macrophage which play an anti-inflammatory role in the lesions of sporotrichosis, the predominance of M2 macrophage may be responsible for the persistence of sporotrichosis; the investigators also found that local hyperthermia is effective in the treatment of sporotrichosis and hyperthermia treatment can activate the CRAC calcium channel in macrophages which triggers pro-inflammatory type M1 polarization and subsequent killing of sporothrix, however, the mechanism still calls for further investigation. The investigators hypothesize that hyperthermia leads to the activation of CRAC channels resulting in profound Ca2+ influx and Ca2+ upregulates NLRP3 inflammasome expression through inducing Nrf2 activation, then NLRP3 overexpression triggers M1 polarization and subsequent killing of sporothrix. Furthermore, the activation of Nrf2 upregulates STIM1 expression which forms a positive feedback for M1 type polarization of macrophages and further subsequent killing of sporothrix. The purpose of this project is to identify the hypothesis that hyperthermia could treat sporotrichosis by promoting pro-inflammatory type M1 polarization in macrophages, the mechanism by which hyperthermia could treat sporotrichosis is local hyperthermia could led to STIM1/CRAC calcium channel activation mediated calcium ions/Nrf2/NLRP3 induced M1 macrophages polarization and subsequent killing of sporothrix. The hypothesis will be identified at the cellular level, at the animal model level and at the clinical specimens level. The investigators believe that the project will guide the application of hyperthermia in the treatment of sporotrichosis and provide a new basis of theory and practice after the investigators achieving these goals. conditions: Sporotrichosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 150 type: ESTIMATED name: Itraconazole name: Infrared thermotherapy apparatus name: Itraconazole and Infrared thermotherapy apparatus measure: the overall clinical clearance rate of skin lesions measure: Overall clinical clearance rate and recurrence rate measure: adverse reactions and incidence measure: the clearance rate of target skin lesions measure: overall lesion clearance rate sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06300125 id: R1881/23 - L2-015 briefTitle: Percutaneous Cryoablation of Low-risk Early Breast Cancer acronym: PRECICE overallStatus: RECRUITING date: 2024-04-15 date: 2026-12-31 date: 2031-03-01 date: 2024-03-08 date: 2024-04-03 name: European Institute of Oncology class: OTHER name: Fondazione Umberto Veronesi name: IceCure Medical Ltd. briefSummary: Expand the current evidence base regarding percutaneous cryoablation of early-stage, low-risk breast tumors, integrated into the standard therapeutic pathway with well-defined follow-up data, as well as data on quality of life. Demonstrate, therefore, that the use of percutaneous cryoablation in the treatment of low-risk breast carcinoma is not inferior to surgery when combined with adjuvant radiotherapy and chemotherapy (when necessary). The hypothesis is that cryoablation, being simple and oncologically effective, ensures a better quality of life for the patient (reduced morbidity, no need for general anesthesia, improved cosmetic outcomes) and consequently has a lesser psychological impact, as well as a better cost-benefit ratio compared to the standard surgical approach. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 234 type: ESTIMATED name: Cryoablation measure: Procedure failure rate measure: Assessment of subject's quality of life in terms of evaluation of sources of distress measure: Assessment of subject's satisfaction measure: Cost-analysis - evaluation of cost of intervention, hospitalization and re-intervention (if applicable) measure: Ipsilateral breast tumor recurrence measure: Distant metastasis sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Franco Orsi role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06300112 id: Amasya Univ_emine.akca briefTitle: Prenatal Yoga on Stress, Quality of Sexual Life and Sleep Level overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-05-31 date: 2024-06-30 date: 2024-03-08 date: 2024-03-12 name: Amasya University class: OTHER briefSummary: The study will investigate the effects of pregnancy yoga on perceived stress, quality of sexual life and sleep level. A total of 100 pregnant women are planned to be included in the study. Data will be collected with the "Personal Information Form", "Perceived Stress Scale" and "Sexual Quality of Life Questionnaire-Female". Yoga will be applied to the experimental group for a total of 12 sessions, two sessions per week (90 minutes) for six weeks. The research predicts that yoga will reduce the stress perceived by pregnant women, increase the quality of sexual life and positively affect sleep patterns. conditions: Stress conditions: Sexuality conditions: Sleep studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized-controlled trial with pretest-posttest control group primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 100 type: ESTIMATED name: YOGA measure: Perceived stress level measure: Sexual Quality of Life measure: Sleep patterns sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Amasya University city: Amasya zip: 05100 country: Turkey name: Emine İbici Akça, Ph.D role: CONTACT phone: 03582115005-4723 email: emine.akca@amasya.edu.tr lat: 40.65333 lon: 35.83306 hasResults: False
<\|newrecord\|> nctId: NCT06300099 id: AZAST/Research/52/20-Jan-2024 briefTitle: Dexamethasone Versus Dexmedetomidine as Adjuncts to Serratus Anterior Plane Block overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-10-01 date: 2024-03-08 date: 2024-03-12 name: Al-Azhar University class: OTHER briefSummary: Modified radical mastectomy is the most commonly performed surgical approach for breast cancer. The procedure enables surgeons to remove the main tumor mass, adjacent glandular tissue and regional lymph nodes. Moreover, it provides a cosmetic outcome that clearly surpasses the standard radical mastectomy and allows subsequent breast reconstruction with favorable results.
The present randomized study aims to compare the postoperative analgesic effects of dexamethasone and dexmedetomidine as adjuncts to serratus anterior plane block in women undergoing modified radical mastectomy. conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 126 type: ESTIMATED name: Dexamethasone name: Dexmedetomidine measure: postoperative visual assessment scale for pain. sex: FEMALE minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06300086 id: NUDGE-CKD briefTitle: Nationwide Utilization of Danish Government Electronic Letter System for Increasing Guideline-directed Medical Therapy in Chronic Kidney Disease acronym: NUDGE-CKD overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2034-10-01 date: 2024-03-08 date: 2024-03-08 name: Tor Biering-Sørensen class: OTHER briefSummary: Kidney Disease Improving Global Outcomes (KDIGO) has recently updated the Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (CKD). This update follows large placebo-controlled randomized trials, which established sodium-glucose cotransporter 2 inhibitors (SGLT2i) as an additional treatment option to reduce the risk of progression to kidney failure and cardiovascular disease in patients with CKD, both with and without diabetes or albuminuria. As a result, SGLT2i is now recommended to a broad range of CKD patients by KDIGO, along with established medical therapies such as renin-angiotensin system inhibition (RASi). Despite the significant adverse consequences of CKD and substantial evidence supporting guideline-directed medical therapy (GDMT) to improve patient outcomes, awareness of CKD among patients and providers remains disproportionately low. Innovative solutions are needed to increase awareness of CKD. Such a solution could potentially be the use of electronic nudge letters delivered to patients with CKD and their general practitioners (GPs) that highlight the importance of GDMT and inform them of updated guidelines.
This study will investigate whether digital nudge letters delivered via the official Danish electronic letter system directly to patients with CKD and their associated GPs will improve GDMT in patients with CKD when compared to no letters. conditions: Chronic Kidney Diseases conditions: Behavior and Behavior Mechanisms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: 2x2 factorial design primaryPurpose: OTHER masking: NONE count: 35000 type: ESTIMATED name: Electronically delivered nudging letters to patients with CKD name: Electronically delivered nudging letter to associated GPs of patients with CKD measure: Number of participants with any prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors measure: Number of participants with any prescription of renin-angiotensin system inhibition measure: Number of participants with any prescription of sodium-glucose cotransporter 2 inhibitors measure: Number of participants with a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors measure: Number of participants with a new prescription of renin-angiotensin system inhibition measure: Number of participants with a new prescription of sodium-glucose cotransporter 2 inhibitors measure: Time from intervention delivery to a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors measure: Time from intervention delivery to a new prescription of renin-angiotensin system inhibition measure: Time from intervention delivery to a new prescription of sodium-glucose cotransporter 2 inhibitors measure: Number of participants with an increase in baseline daily RASi dosage measure: Number of participants with any prescription of mineralocorticoid receptor antagonists measure: Number of participants with any prescription of non-steroid mineralocorticoid receptor antagonists measure: Number of participants with any prescription of cholesterol-lowering medication measure: Number of participants with any prescription of glucagon-like peptide-1 analogue measure: Number of participants with any prescription of antidiabetic medication besides SGLT2i measure: Number of participants with any prescription of antidiabetic medication measure: Number of participants with any prescription of antihypertensive medication besides renin-angiotensin system inhibition measure: Number of participants with any prescription of antihypertensive medication measure: Number of participants with a new prescription of mineralocorticoid receptor antagonists measure: Number of participants with a new prescription of non-steroid mineralocorticoid receptor antagonists measure: Number of participants with a new prescription of cholesterol-lowering medication measure: Number of participants with a new prescription of glucagon-like peptide-1 analogue measure: Number of participants with a new prescription of antidiabetic medication besides sodium-glucose cotransporter 2 inhibitors measure: Number of participants with a new prescription of antidiabetic medication measure: Number of participants with a new prescription of antihypertensive medication besides renin-angiotensin system inhibition measure: Number of participants with a new prescription of antihypertensive medication measure: Change in number of antihypertensive medications measure: Number of participants referred to nephrology outpatient clinics measure: Number of participants with an assessment of urine albumine to creatine ratio measure: Number of participants with an assessment of plasma-creatinine. measure: Number of participants with an assessment of estimated glomerular filtration rate by creatinine measure: Number of participants with an assessment of hemoglobin A1c measure: Number of participants with an assessment of lipids measure: Number of participants recipient of influenza vaccination measure: Number of participants recipient of COVID-19 vaccination measure: Total number of visits to general practitioners measure: Time to first phone contact to a general practice measure: Time to first visit with a general practitioner measure: Number of participants with any prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors measure: Number of participants with any prescription of renin-angiotensin system inhibition measure: Number of participants with any prescription of sodium-glucose cotransporter 2 inhibitors measure: Number of participants with a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors measure: Number of participants with a new prescription of renin-angiotensin system inhibition measure: Number of participants with a new prescription of sodium-glucose cotransporter 2 inhibitors measure: Time from intervention delivery to prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors measure: Time from randomization to prescription of renin-angiotensin system inhibition measure: Time from randomization to prescription of sodium-glucose cotransporter 2 inhibitors measure: Number of participants who have discontinued renin-angiotensin system inhibition treatment. measure: Number of participants who have discontinued sodium-glucose cotransporter 2 inhibition treatment. measure: Rate of change in estimated glomerular filtration rate measure: Rate of change in urine albumine to creatinine ratio measure: Number of participants with any hospitalization measure: Total number of all-cause hospitalizations measure: All-cause mortality measure: Number of participants with kidney failure defined as a composite of sustained estimated glomerular filtration rate <15ml/min/1.73m2, dialysis dependence and kidney transplantation measure: Number of participants with kidney failure (alternative definition #1) defined as a composite of sustained estimated glomerular filtration rate <15ml/min/1.73m2, dialysis dependence, kidney transplantation and renal death measure: Number of participants with kidney failure (alternative definition #2) defined as a composite of sustained estimated glomerular filtration rate <15ml/min/1.73m2, dialysis dependence, kidney transplantation, renal death, and cardiovascular death. measure: Number of participants with acute dialysis measure: Number of participants with acute kidney insufficiency measure: Number of participants with incident heart failure, heart failure hospitalization, or cardiovascular death measure: Number of participants with major adverse cardiovascular events defined as a composite of myocardial infarction, stroke, and cardiovascular death. measure: Number of participants with major adverse cardiovascular events (alternative definition) defined as a composite of myocardial infarction, revascularization, stroke, and cardiovascular death. measure: Number of participants with individual components of the renal/cardiovascular composite outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte city: Hellerup state: Hovedstaden zip: 2900 country: Denmark lat: 55.73204 lon: 12.57093 hasResults: False
<\|newrecord\|> nctId: NCT06300073 id: AB-360-001-2022 briefTitle: Plaque Removal Efficacy of a U-Shaped Sonic Power Toothbrush in Children overallStatus: COMPLETED date: 2023-02-14 date: 2023-02-17 date: 2023-02-17 date: 2024-03-08 date: 2024-03-08 name: Lander Enterprises, LLC class: INDUSTRY briefSummary: The objective of this single-use, examiner blinded, randomized, two-period, cross-over, IRB-approved clinical study is to evaluate the safety and plaque removal efficacy of AutoBrush®, a new children's 360° sonic toothbrush, compared to a marketed children's manual toothbrush. conditions: Dental Plaque studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: single-use, randomized, two-period, cross-over study primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Examiner and data recorder will not have access to the room for test materials dispensing and instructions. whoMasked: OUTCOMES_ASSESSOR count: 22 type: ACTUAL name: Experimental: U-shaped Power Toothbrush name: Placebo Comparator: Soft Manual Toothbrush measure: Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal Mean Change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all tooth surfaces of the whole mouth. sex: ALL minimumAge: 5 Years maximumAge: 8 Years stdAges: CHILD facility: Salus Research, Inc city: Fort Wayne state: Indiana zip: 46825 country: United States lat: 41.1306 lon: -85.12886 hasResults: False
<\|newrecord\|> nctId: NCT06300060 id: REB23-1161 briefTitle: Synbiotic Supplementation in Cyclists overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-02-01 date: 2025-02-01 date: 2024-03-08 date: 2024-03-08 name: University of Calgary class: OTHER name: Lallemand Health Solutions briefSummary: The goal of this clinical trial is to assess the efficacy of a synbiotic blend on exercise performance and other exercise parameters in trained adult cyclists. It is hypothesized that those taking the synbiotic blend will have improved endurance exercise performance.
The primary objective is to assess the impact of a synbiotic on 20km distance trial performance in 36 cyclists. Secondary objectives include assessing the impact of the synbiotic on exercise metabolism, body composition, gastrointestinal and immune health. conditions: Exercise Endurance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel arm. Single-site, double-blinded, placebo-controlled trial. primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE maskingDescription: The synbiotic and placebo are both powders identical in taste and appearance and are equally dissolvable in cold water. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Synbiotic name: Placebo measure: Change in endurance exercise performance measured during a 20km cycling distance trial measure: Change in maximal oxygen consumption (V̇O2max) measured during a Step-Ramp-Step Test measure: Change in peak power output (PPO) measured during a Step-Ramp-Step Test measure: Change in power output corresponding to the gas exchange threshold (GET) and respiratory compensation point (RCP) measure: Change in time to exhaustion measured during a cycling session at 85% of the peak power output measure: Change in fat and carbohydrate oxidation measured during exercise sessions measure: Change in blood lactate concentration measured via pinprick capillary blood test measure: Change in body composition measured by dual energy X-ray absorptiometry (DXA) measure: Change in intestinal permeability markers measured in serum measure: Change in cytokines measure: Change in gastrointestinal symptoms measured by self-report measure: Change in fecal SCFA concentration measured by gas chromatography measure: Synbiotic strains quantification measured by qPCR in fecal matter measure: Change in fecal microbiota composition measure: Incidence of adverse events sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: University of Calgary city: Calgary state: Alberta zip: T2N 1N4 country: Canada name: Raylene A Reimer, PhD, RD role: CONTACT phone: 403-220-8218 email: reimer@ucalgary.ca lat: 51.05011 lon: -114.08529 hasResults: False
<\|newrecord\|> nctId: NCT06300047 id: REB23-0679 briefTitle: Diabetes Transition Coordinator Study overallStatus: ENROLLING_BY_INVITATION date: 2024-04-01 date: 2028-12-31 date: 2028-12-31 date: 2024-03-08 date: 2024-03-08 name: University of Calgary class: OTHER name: Juvenile Diabetes Research Foundation name: Canadian Institutes of Health Research (CIHR) briefSummary: The goal of this interventional study is to assess the effects and evaluate the implementation of a pediatric to adult care transition intervention in youth with T1D on clinical, patient-reported, and implementation outcomes, including an economic analysis.
The 3 main aims are:
1. To assess the effects of our transition intervention on clinical and patient-reported outcomes.
2. To implement the transition intervention and evaluate the implementation outcomes.
3. To evaluate the economic impacts of the transition intervention. Participants will have access to a transition coordinator before, during, and after their planned transition from pediatric to adult care as standard of care.
Researchers will compare a pre-intervention cohort to evaluate the impact of the transition coordinator intervention. conditions: Type 1 Diabetes studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The usual care group is defined as the group who receives usual care and serves as the control group. This group is defined prior to the implementation of the intervention. We include a two month wash out period between our two groups to avoid care providers 'holding on' to patients they feel may benefit from the intervention primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 324 type: ESTIMATED name: Non-Medical Transition Coordinator measure: Lost to Followup measure: Patient Reported Outcome Survey 1 measure: Patient Reported Outcome Survey 2 measure: Patient Reported Outcome Survey 3 measure: Clinical Outcome 1 measure: Clinical Outcome 2 measure: Clinical outcome 3 measure: Clinical outcome 4 measure: Clinical Outcome 5 measure: Clinical Outcome 6 sex: ALL minimumAge: 17 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Alberta Children's Hospital city: Calgary state: Alberta country: Canada lat: 51.05011 lon: -114.08529 hasResults: False
<\|newrecord\|> nctId: NCT06300034 id: bagattoni2 briefTitle: Parental Perceptions and Acceptance of Silver Diamine Fluoride in Italy acronym: SDF overallStatus: COMPLETED date: 2020-09-01 date: 2022-02-01 date: 2022-03-01 date: 2024-03-08 date: 2024-03-08 name: University of Bologna class: OTHER briefSummary: Parental perceptions on staining due to Silver Diamine Fluoride (SDF) could affect its implementation in pediatric dentistry. This study represents the second part of a wider project focused on SDF aesthetic acceptability among Italian parents. conditions: Perceptions conditions: Acceptability conditions: SDF studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 234 type: ACTUAL measure: Parental overall acceptance of SDF staining on anterior and posterior teeth measure: Parental willingness to accept SDF treatment on anterior and posterior teeth depending on child's behavior measure: Parental overall acceptability of SDF staining according to demographic background sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile city: Bologna country: Italy lat: 44.49381 lon: 11.33875 hasResults: False
<\|newrecord\|> nctId: NCT06300021 id: PEC19242 id: 2021-A00317-34 type: OTHER domain: ID-RCB briefTitle: Bioavailability of Curcuminoids From Turmipure Gold® in Different Food Matrices overallStatus: COMPLETED date: 2021-09-14 date: 2022-05-20 date: 2022-05-20 date: 2024-03-08 date: 2024-03-08 name: Givaudan France Naturals class: INDUSTRY name: BioFortis briefSummary: The goal of this clinical trial is to learn about the extent to which turmeric compounds in different food matrices becomes available to the body in healthy volunteers. The main question it aims to answer is:
* Is the availability to the body of a turmeric dietary supplement altered when consumed in fruit nectar, oat milk, yogurt drink, or gummies in comparison to a dietary supplement capsule?
Participants will ingest a turmeric dietary supplement as a capsule or in different food matrices on six testing days (separated by at least one week). The day before testing day, a standardized dinner will be provided to the participants in the evening and participants will be instructed to not consume any foods or beverages (except water) and to arrive fasted (12 hours) at the investigation site. Participants will ingest turmeric dietary supplement formulations one by one in random order in the morning of testing days. Regular blood and urine samples will be collected before and up to 24 hours after the turmeric dietary supplement ingestion. Standardized meals will be provided during the entire testing day (lunch, mid-afternoon snack, dinner). conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Monocentric, randomized, cross-over, open-label, pharmacokinetic study primaryPurpose: BASIC_SCIENCE masking: NONE count: 35 type: ACTUAL name: TPG capsule name: TPG ready to drink name: TPG dairy analog name: TPG probiotic drink name: TPG gummies name: TPG sport bar measure: Dose-normalized AUC0-24h of total curcuminoids measure: Dose-normalized AUC0-24h of curcuminoid compounds and of their metabolites measure: Dose-normalized AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites measure: Dose-normalized AUC0-∞ of total curcuminoids, curcuminoid compounds and of their metabolites measure: AUC0-24h of total curcuminoids, curcuminoid compounds and of their metabolites measure: AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites measure: AUC0-∞ of total curcuminoids, curcuminoid compounds and of their metabolites measure: Relative bioavailability for normalized AUC0-24h of total curcuminoids, curcuminoid compounds and of their metabolites measure: Relative bioavailability for normalized AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites measure: Relative bioavailability for normalized AUC0-∞ of total curcuminoids, curcuminoid compounds and of their metabolites measure: Cmax of total curcuminoids, curcuminoid compounds and of their metabolites measure: Dose-normalized Cmax of total curcuminoids, curcuminoid compounds and of their metabolites measure: Half-life of total curcuminoids, curcuminoid compounds and of their metabolites measure: Tmax of total curcuminoids, curcuminoid compounds and of their metabolites sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Biofortis city: Saint-Herblain zip: 44800 country: France lat: 47.21765 lon: -1.64841 hasResults: False
<\|newrecord\|> nctId: NCT06300008 id: OrthoTU13 briefTitle: Cetylated Fatty Acid for Reducing Pain After TKA overallStatus: RECRUITING date: 2024-02-12 date: 2024-09 date: 2024-12 date: 2024-03-08 date: 2024-03-08 name: Thammasat University class: OTHER briefSummary: To compare efficacy of cetylated fatty acid with placebo for reducing postoperative pain after unilateral TKA. The hypothesis is topical cetylated fatty acid can mitigate postoperative pain after TKA. conditions: Postoperative Pain conditions: Postoperative Inflammation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: cetylated fatty acid name: Placebo measure: Visual analog scale measure: Visual analog scale measure: Visual analog scale measure: Visual analog scale measure: inflammatory marker measure: inflammatory marker measure: inflammatory marker measure: inflammatory marker measure: Knee skin temperature measure: Knee skin temperature measure: Knee skin temperature measure: Knee skin temperature measure: Knee circumference (cm) measure: Knee circumference (cm) measure: Knee circumference (cm) measure: Knee circumference (cm) measure: Knee Range of Motion measure: Knee Range of Motion measure: Knee Range of Motion measure: Knee Range of Motion measure: Modified WOMAC measure: Modified WOMAC measure: Modified WOMAC measure: Thai forgotten joint score measure: Thai forgotten joint score measure: Thai forgotten joint score sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: department of orthopaedic surgery, Faculty of medicine, Thammasat university status: RECRUITING city: Khlong Luang state: Pathumthani zip: 066 country: Thailand name: supakit kanitnate role: CONTACT phone: 6629260000 email: naypeng@hotmail.com name: Nattapol Tammachote, M.D. role: PRINCIPAL_INVESTIGATOR name: Supakit Kanitnate, M.D. role: SUB_INVESTIGATOR lat: 14.06467 lon: 100.64578 hasResults: False
<\|newrecord\|> nctId: NCT06299995 id: MFSP briefTitle: Phenotype and Burden of a Midfacial Segment Pain overallStatus: ENROLLING_BY_INVITATION date: 2024-02-24 date: 2025-03-31 date: 2025-03-31 date: 2024-03-08 date: 2024-03-19 name: Swiat Zdrowia class: OTHER briefSummary: The purpose of this study is to describe midfacial segment pain phenotype, burden and comorbidities in a multicentre and multidisciplinary setting. The ultimate goal is a comprehensive description of this type of pain allowing for its implementation in future classifications.
This cross-sectional study is designed to describe midfacial segment pain in a clinical setting. Patients from rhinologic, headache and facial pain or oral medicine/dentistry secondary care centres will be recruited during a one year period. Individuals with other facial pain according to current classification such as sinonasal disorders, neoplasms, local infections, history of significant trauma associated with pain onset will be excluded. Data will be collected through a structured questionnaire covering pain characteristics, coexisting diagnoses, pain-related burden and consequences, physical examination and paranasal sinuses imaging. conditions: Facial Pain studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED measure: Pain characteristics measure: Coexisting diagnoses measure: Pain-related burden and consequences sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Otolaryngology, University of Malta city: Imsida country: Malta lat: 35.8925 lon: 14.48278 facility: Athleticomed - Pain&Headache Treatment Centre city: Bydgoszcz country: Poland lat: 53.1235 lon: 18.00762 facility: Department of Otolaryngology, Head and Neck Surgery and Laryngological Oncology city: Bydgoszcz country: Poland lat: 53.1235 lon: 18.00762 facility: Department of Neurology, Jagiellonian University Medical College city: Kraków country: Poland lat: 50.06143 lon: 19.93658 facility: Świat Zdrowia city: Orzyny zip: 12-120 country: Poland lat: 53.67846 lon: 21.06617 facility: Department of Neurology and Restorative Medicine, Health Institute dr Boczarska-Jedynak city: Oświęcim country: Poland lat: 50.03437 lon: 19.21037 facility: 4. Department of Otorhinolaryngology, National Institute of Medicine of the Ministry of the Interior and Administration city: Warsaw country: Poland lat: 52.22977 lon: 21.01178 facility: 5. Department of Otolaryngology, Centre of Postgraduate Medical Education city: Warsaw country: Poland lat: 52.22977 lon: 21.01178 facility: Department of Experimental Dentistry, Wroclaw Medical University city: Wrocław country: Poland lat: 51.1 lon: 17.03333 facility: Department of Neurology, Wroclaw Medical University city: Wrocław country: Poland lat: 51.1 lon: 17.03333 facility: MIGRE Polish Migraine Center city: Wrocław country: Poland lat: 51.1 lon: 17.03333 facility: Pain Medicine, Liverpool University Hospitals NHS Foundation Trust city: Liverpool country: United Kingdom lat: 53.41058 lon: -2.97794 facility: Department of Otorhinolaryngology, Nottingham University Hospital city: Nottingham country: United Kingdom lat: 52.9536 lon: -1.15047 hasResults: False
<\|newrecord\|> nctId: NCT06299982 id: SSGJ-608-PsO-III-02 briefTitle: An Phase III Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With PsO overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-01-30 date: 2025-03-20 date: 2024-03-08 date: 2024-03-08 name: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to examin the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis. conditions: Plaque Psoriasis Patients studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 750 type: ESTIMATED name: 608 Q2W name: 608 Q4W measure: Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) measure: Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement measure: Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) measure: Percentage of Participants Achieving a ≥100% Improvement in Psoriasis Area and Severity Index (PASI 100) measure: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0) measure: Adverse events (AE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06299969 id: StBernwardH briefTitle: Feedback Intervention and Treatment Trial in Patients With Out-of-Hospital Cardiac Arrest acronym: FITT-OHCA overallStatus: RECRUITING date: 2023-01-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-08 date: 2024-03-08 name: St.Bernward Hospital class: OTHER name: University Medical Center Goettingen briefSummary: The trial collects and analyzes data from Cardiac Arrest Centres in patients with out-of-hospital cardiac arrest (OHCA). conditions: Out-Of-Hospital Cardiac Arrest studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED measure: In-hospital mortality measure: CPC score measure: MRS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St Bernward Hospital status: RECRUITING city: Hildesheim state: Niedersachsen zip: 31134 country: Germany name: Karl H Scholz, MD role: CONTACT phone: +4955139 phoneExt: 64940 email: k.scholz@fitt-stemi.de name: Sebastian Riedel role: CONTACT phone: +4955139 phoneExt: 64940 email: s.riedel@bernward-khs.de lat: 52.15077 lon: 9.95112 hasResults: False
<\|newrecord\|> nctId: NCT06299956 id: 2023-SFHHB-IC-001 briefTitle: Supervised Exercise-based Rehabilitation for People With Intermittent Claudication in Denmark acronym: StRiDE overallStatus: RECRUITING date: 2023-09-01 date: 2029-01 date: 2029-01 date: 2024-03-08 date: 2024-03-21 name: Slagelse Hospital class: OTHER name: Region Zealand name: Vordingborg Municipality name: Kalundborg municipality name: Køge Municipality name: Næstved municipality name: Solrød Municipality briefSummary: The goal of this project is to implement a protocol for a supervised exercise therapy intervention including smoking cessation in the municipalities in region Zealand in Denmark. The participants are adults with intermittent claudication.
The objective of this project is to describe:
1. The development and design of the implementation process of a rehabilitative intervention including SET and smoking cessation in Region Zealand with a 6-month follow-up period after completion of the SET.
2. The ongoing quality monitoring process of the implementation in terms of referral, recruitment, retention, data completeness, intervention delivery and attendance and to collect feedback that will guide refinements of the intervention delivery and data collection.
3. Outcomes available for assessment of benefits and harms from the SET intervention.
Participants will be asked to do supervised exercise therapy by walking on a treadmill for 3 times a week for 12 weeks, and engage in smoking cessation, if they are smoking. conditions: Intermittent Claudication studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 600 type: ESTIMATED name: Supervised exercise therapy measure: Maximal Walking Distance measure: Pain-free walking distance measure: Vascular Quality of Life Questionnaire-6 (VASCUQoL-6) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PROgrez status: RECRUITING city: Slagelse zip: 4700 country: Denmark name: Helle Bøgard role: CONTACT email: hboga@regionsjaelland.dk name: Lars Tang role: CONTACT email: larta@reggionsjaelland.dk lat: 55.40276 lon: 11.35459 hasResults: False
<\|newrecord\|> nctId: NCT06299943 id: BiofeedbackTargetGaitTraining briefTitle: Biofeedback Gait Training by Target Biomechanical Parameters in the Early Recovery Period of Stroke acronym: TargetGait overallStatus: RECRUITING date: 2022-01-24 date: 2025-12-30 date: 2025-12-30 date: 2024-03-08 date: 2024-03-12 name: Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health class: OTHER briefSummary: Single-blinded controlled clinical trial. Biofeedback training courses based on target biomechanical gait parameters are being studied. For targeted biofeedback training, various biomechanical parameters are used: parameters of the gait cycle, EMG or kinematics of joint movements. The number of sessions is 8-11 for each patient. Clinical gain analysis is carried out before and after a course of training. Changes in biomechanical parameters that occurred at the end of the training course are assessed in comparison with those before training, and both statuses (before and after training) are compared with similar gait parameters in a group of healthy adults. conditions: Stroke conditions: Biofeedback conditions: Gait, Hemiplegic conditions: Gait Training conditions: Hemiparesis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel-group, single-blinded controlled clinical trial. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Clinicians involved in the measurements and researchers that worked with data results did not know which group each patient was in. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Biofeedback gait training by biomechanical target parameter measure: Gait cycle measure: Foot clearance measure: Speed of walking measure: Stance phase measure: Single support phase measure: Hip joint amplitude measure: Knee joint amplitude measure: Ankle joint amplitude measure: EMG amplitude of tibialis anterior muscle measure: EMG amplitude of gastrocnemus muscle measure: EMG amplitude of quadriceps femoris muscle measure: EMG amplitude of Hamstring muscle measure: Muscle strength measure: Activities of Daily Living measure: Modified Rankin Scale for Neurologic Disability measure: The Timed Up and Go Test measure: The Medical Research Council Weakness Scale sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: FCCerebroPathStroke status: RECRUITING city: Moscow zip: 117997 country: Russian Federation name: Dmitry Skvortsov, PhD role: CONTACT phone: +79166925419 email: skvortsov.biom@gmail.com lat: 55.75222 lon: 37.61556 hasResults: False
<\|newrecord\|> nctId: NCT06299930 id: LRR after NACT vs ACT briefTitle: Locoregional Recurrence After Neoadjuvant Versus Adjuvant Chemotherapy overallStatus: COMPLETED date: 2022-04-22 date: 2023-08-16 date: 2023-09-12 date: 2024-03-08 date: 2024-03-08 name: Seoul National University Hospital class: OTHER briefSummary: Neoadjuvant chemotherapy (NACT) for early-stage breast cancer is associated with an increased risk of locoregional recurrence (LRR). However, few studies have conducted subgroup analyses of patients with various molecular subtypes, which are one of the determinant factors for treatments. The aim of the study is to investigate whether the risk of LRR after NACT varies across tumor subtypes. The investigators retrospectively reviewed the medical records of female breast cancer patients who underwent breast-conserving surgery at three institutions between January 1, 2004, and Dec 31, 2018. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 10328 type: ACTUAL name: Neoadjuvant chemotherapy name: Adjuvant chemotherapy measure: Locoregional recurrence-free survival (LRR) measure: Distant metastasis-free survival sex: FEMALE minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital city: Seoul zip: 03080 country: Korea, Republic of lat: 37.566 lon: 126.9784 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2022-04-22 uploadDate: 2024-03-01T20:58 filename: Prot_SAP_000.pdf size: 151396 hasResults: False
<\|newrecord\|> nctId: NCT06299917 id: CeViG id: S-20232000 - 3 type: OTHER domain: Committees on Health Research Ethics for Southern Denmark briefTitle: WORK-ON Vocational Rehabilitation for People With Inflammatory Arthritis acronym: WORK-ON overallStatus: RECRUITING date: 2024-03-01 date: 2027-09-01 date: 2027-09-01 date: 2024-03-08 date: 2024-04-17 name: The Danish Center for Expertise in Rheumatology class: OTHER name: Odense Patient Data Explorative Network name: The Danish Rheumatism Association name: Danish Association of Occupational Therapist name: Schaufuss foundation briefSummary: People with chronic inflammatory arthritis (IA) (rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis), often have a reduced work ability. Up to 40% lose their job in the first years after diagnosis. Consequently, they are at high risk of losing their jobs and being permanently excluded from the labour market. Therefore, a new context-specific vocational rehabilitation (VR) for people with IA was developed, based on the Medical Research Council's framework for complex interventions. The 6-months VR is called WORK-ON and consists of three parts: 1) a coordinating occupational therapist who performs an initial assessment and goalsetting process and supports cooperation between relevant partners and navigation between sectors, 2) Four group sessions with peers and if needed, 3) Individual sessions with a social worker, nurse, or physiotherapist. The objective of the WORK-ON trial is to test the overall efficacy on work ability compared to a control group who receives usual care and pamphlets for their employer and colleagues.
Based on the experiences from a feasibility study, WORK-ON will be conducted as a randomised controlled trial. Patients with IA, aged 18 years or older, experiencing job insecurity will be randomised to one of two groups: the WORK-ON VR group or usual care (control group). The primary outcome; work ability measured is measured by Work Ability Index single item, at baseline, 6, 12, 18 and 30 months after baseline. Secondary outcomes are absenteeism, presenteeism, overall work impairment, activity impairment, job loss, quality of life, mental well-being, fatigue, sleep, physical activity, occupational balance and pain. Secondary outcomes are measured at baseline, 6 and 12 months after baseline. In addition, work ability, working hours per week and job loss are measured at 18 and 30 months after baseline. conditions: Rheumatoid Arthritis conditions: Psoriatic Arthritis conditions: Axial Spondyloarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single center parallel randomized study primaryPurpose: OTHER masking: NONE maskingDescription: Statistical analyses will be blinded for group allocation count: 56 type: ESTIMATED name: WORK-ON measure: Work Ability Index (WAI) single item measure: Job loss measure: Work hours per week measure: Work Productivity and Activity Impairment questionnaire, general health (WPAI:GH) measure: Sickness absenteeism measure: Work ability in relation to demands measure: Job insecurity measure: Physical activity while at work measure: Occupational balance measure: Health related quality of life measure: VAS Pain measure: Fatigue measure: Physical activity measure: Mental well-being measure: Sleep measure: Work Ability Index (WAI) single item sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Danish Hospital for Rheumatic Diseases status: RECRUITING city: Sønderborg zip: 6400 country: Denmark name: Christina MT Madsen, MSci role: CONTACT phone: +4528551373 email: cmadsen@danskgigthospital.dk name: Jette Primdahl, PhD role: CONTACT phone: +4524206692 email: jprimdahl@danskgigthospital.dk lat: 54.90896 lon: 9.78924 hasResults: False
<\|newrecord\|> nctId: NCT06299904 id: stroke briefTitle: Effect of Modified Air-pulse Stimulation on Tracheotomised Patients With Dysphagia After Stroke overallStatus: RECRUITING date: 2023-12-01 date: 2024-12-01 date: 2024-12-01 date: 2024-03-08 date: 2024-03-08 name: The Second Affiliated Hospital of Dalian Medical University class: OTHER briefSummary: To evaluate the efficacy of flexible endoscopy-mediated modified air-pulse stimulation in restoring of swallowing function in this group of patients.Forty-two subacute stroke patients with tracheotomy and dysphagia need to be recruited and divided into a control group of 21 cases and a trial group of 21 cases. On the basis of receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy, while the trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy. Murray secretion scale (MSS), penetration-aspiration scale (PAS) and spontaneous swallowing frequency were used to assess dysphagia. Moreover, clinical pulmonary infection score (CPIS) was used for evaluating the degree of pneumonia, hemoglobin(Hb) and serum prealbumin (PAB) were used to assess the nutritional status of patients. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 42 type: ESTIMATED name: Modified Air-pulse Stimulation name: Conventional air-pulse stimulation measure: the score of Fiberoptic endoscopic examination of swallowing (FEES) measure: the score of Murray's secretion scale (MSS) measure: the score of penetration-aspiration scale (PAS) measure: the score of Clinical Pulmonary Infection Score (CPIS) sex: ALL minimumAge: 30 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the Second Affiliated Hospital of Dalian Medical University status: RECRUITING city: Dalian state: Liaoning zip: 116024 country: China name: wuyao Pan, postgraduate role: CONTACT phone: +86-18186766836 email: 331189506@qq.com lat: 38.91222 lon: 121.60222 hasResults: False
<\|newrecord\|> nctId: NCT06299891 id: PhT_HypOb_Protocol_Clean_07-05 briefTitle: Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-31 date: 2026-05-31 date: 2024-03-08 date: 2024-04-16 name: Seattle Children's Hospital class: OTHER name: Children's Hospital of Philadelphia briefSummary: Hypothalamic obesity (HO) refers to the substantial weight gain that often complicates hypothalamic brain tumors. Children with this treatment-recalcitrant form of obesity have excess rates of metabolic sequelae compared to otherwise healthy children with similar obesity, and later experience excess mortality related to cardiometabolic disease. In this pilot trial, our objective is to gather key preliminary data about phentermine/topiramate (Ph/T) that is FDA-approved for "common" obesity but has never been tested in HO. The subset of individuals with HO who experience hyperphagia or excess daytime sleepiness may benefit from the Ph/T-induced decrease in appetite and increase in alertness.
Preliminary assessments of safety, adverse events, dosing (Aim 1), as well as of efficacy (% BMI loss, Aim 2) will be made in a 28-week parallel-arm double-blinded Phase 2 placebo-controlled clinical trial in 12-28-year-old individuals with HO. conditions: Hypothalamic Obesity conditions: Hypothalamic Tumor conditions: Craniopharyngioma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two-center, double-blind (participant and assessor), randomized, parallel-arm placebo-controlled 28-week clinical trial, comparing changes related to active drug (Qsymia®) vs. placebo (matched capsules). primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Eligible subjects will be assigned treatment using a sex-stratified permuted-block randomization (1:1) to drug vs. placebo for 27 weeks with varying block sizes constructed by the study statistician. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Phentermine / Topiramate Extended Release Oral Capsule [Qsymia] name: Placebo measure: Treatment-emergent adverse events measure: Maximum tolerated dose measure: % change in BMI measure: Proportion of individuals who experience 5% decrease in BMI measure: Proportion of individuals who experience 2.5% decrease in BMI measure: Change in body fat mass measure: Change in visceral fat mass measure: Change in hunger measure: Change in energy intake sex: ALL minimumAge: 12 Years maximumAge: 28 Years stdAges: CHILD stdAges: ADULT facility: The Children's Hospital of Philadelphia city: Philadelphia state: Pennsylvania zip: 19104 country: United States lat: 39.95233 lon: -75.16379 facility: Seattle Children's city: Seattle state: Washington zip: 98101 country: United States name: Clinton Elfers role: CONTACT phone: 513-290-5710 email: clinton.elfers@seattlechildrens.org lat: 47.60621 lon: -122.33207 hasResults: False
<\|newrecord\|> nctId: NCT06299878 id: MelPRO-0322 briefTitle: MelPRO-0322 (CRISTINA Trial) [miCrobiome pRedIctS aPD1 effecTivnes In melaNoma pAtietns] acronym: CRISTINA overallStatus: RECRUITING date: 2022-01-01 date: 2024-12-31 date: 2025-07-01 date: 2024-03-08 date: 2024-03-08 name: Russian Academy of Medical Sciences class: OTHER briefSummary: The goal of this observational study is to learn about if new biomarkers such as gut microbiota and molecular genetics melanoma features could predict clinical radiological and pathological response to neoadjuvant monotherapy with anti-PD1 agents in patients with resectable stage IIIB-D melanoma. The main questions it aims to answer are:
* radiological and pathological response rate to three doses of antiPD1 agents;
* do radiological and pathological responses correlate with gut microbiota and melanoma molecular genetics features Participants will receive three doses of aPD1 monotherapy as per center routine practice and will undergo regional lymphadenectomy. Before treatment initiation patients will be asked to bring faeces probes and fill out dietary questionnaire as well as just before the surgery.
After sugery adjuvant therapy will be prescribed for 12 month and patients will be followed up according to institutional routine practice for 5 years. conditions: Melanoma, Skin conditions: Melanoma Stage Iii studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 72 type: ESTIMATED name: Gut microbiota analysis measure: 2-year disease-free survival measure: pathological response rate measure: biomarker reproducibility sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: N.N. Blokhin Russian Cancer Research Center, skin tumor department status: RECRUITING city: Moscow zip: 115478 country: Russian Federation name: Igor V Samoylenko, MD, PhD role: CONTACT phone: +7 (499) 444-24-24 email: i.samoylenko@ronc.ru name: Angelina O Kuzmenko, MD role: CONTACT phone: +74993249024 email: angelin.kuzmenko@gmail.com name: Igor V Samoylenko, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 hasResults: False
<\|newrecord\|> nctId: NCT06299865 id: YXLL-KY-2023（150） briefTitle: Comparison of Detection Rates Between Two Commonly Used Bone Density Measurement Methods overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-08 date: 2024-03-08 name: Xiaoqian Zhang class: OTHER briefSummary: 72 adult patients who underwent lumbar spine anteroposterior DXA and QCT examinations at Qianfoshan Hospital in Shandong Province from January 2019 to December 2022 were selected, with an interval of no more than 3 months between the two examinations for the same patient.
1. Record the patient's age, gender, height, and weight; Review the patient's past medical history (especially whether there is a history of brittle fractures, whether there is a history of using drugs that affect bone metabolism, etc.).
2. Retrieve the bone density values of the anterior lumbar vertebrae 1 to 4 measured by GE Healthcare Lunar Prodigy dual energy X-ray absorptiometry from the database, and take the average (DXA bone density value). According to the diagnostic criteria of the Diagnosis and Treatment Guidelines for Primary Osteoporosis (2022), determine whether the patient has normal bone mass, decreased bone mass, or osteoporosis.
3. Identify the lumbar spine bone density values (QCT bone density values) measured by the GE Gemstone CTHD750 CT instrument from the database. According to the diagnostic criteria of the Chinese Quantitative CT (QCT) Diagnosis Guidelines for Osteoporosis (2018), determine whether the patient has normal bone mass, decreased bone mass, or osteoporosis.
4. Statistical analysis was conducted on the normal bone density, bone loss, and number of osteoporosis diagnosed by DXA and QCT respectively, in order to explore the differences in the detection rates of osteoporosis between these two monitoring methods. The data was analyzed and processed using SPSS 21.0 statistical software, and the count data was expressed as a rate (%) χ 2-test, P\<0.05 indicates statistically significant difference; Explore whether the difference in detection rates between the two is related to factors such as weight; Calculate the detection rates of osteoporosis using two detection methods in patients who have experienced brittle fractures, and preliminarily determine which detection method is more accurate in determining osteoporosis. conditions: Osteoporosis conditions: Diagnosis conditions: Dual Energy X-ray Absorptiometry conditions: Quantitative Computed Tomography studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 72 type: ESTIMATED name: Ungrouped measure: Comparison of the difference in detection rates of osteoporosis between dual energy X-ray and quantitative CT sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shandong Provincial Qianfoshan Hospital city: Jinan state: Shandong country: China lat: 36.66833 lon: 116.99722 hasResults: False
<\|newrecord\|> nctId: NCT06299852 id: TK01 briefTitle: Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer overallStatus: RECRUITING date: 2022-07-01 date: 2025-09-01 date: 2025-09-01 date: 2024-03-08 date: 2024-03-08 name: N.N. Petrov National Medical Research Center of Oncology class: OTHER briefSummary: This study involves two non-randomized groups of patients: the observation group and the comparison group. The comparison group will retrospectively include data on 29 patients with oligometastatic HER2-positive breast cancer who received treatment with trastuzumab-emtansine and had a history of SRT.
The prospective part of this study aims to include 29 patients with oligometastatic HER2-positive breast cancer. These patients will undergo SRT followed by the administration of trastuzumab emtansine 24 hours after the SRT.
The combined effect of stereotactic radiation therapy on a metastatic lesion followed by anti-HER2 therapy in the 2nd line - trastuzumab emtansine, remains unexplored. This study plans to evaluate the effectiveness of combining systemic therapy and local control methods (SRT) in patients with oligometastatic HER2-positive breast cancer. It will be the first time the efficacy and toxic profile of this new combined treatment method in this patient population will be studied. This basket trial evaluates trastuzumab emtansine for oligo-metastatic breast cancer with the aim of inducing deep responses, long-lasting disease remissions, and potentially cure. conditions: HER2-positive Metastatic Breast Cancer conditions: Oligometastatic Disease studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 58 type: ESTIMATED name: Trastuzumab emtansine measure: Objective response rate (ORR) measure: Progression free survival (PFS) measure: Toxicity profile measure: Second co-primary outcome measure is quality of life sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: N.N. Petrov National Medical Research Center of Oncology status: RECRUITING city: Saint Petersburg country: Russian Federation name: Tatiana Semiglazova, DSc Med., Prof. role: CONTACT email: tsemiglazova@mail.ru name: Tatiana Kudryashova role: CONTACT phone: +79632165730 email: tatyana-kudryashova-98@mail.ru lat: 59.93863 lon: 30.31413 hasResults: False
<\|newrecord\|> nctId: NCT06299839 id: PAS-004-102 id: 2024-510900-34 type: EUDRACT_NUMBER briefTitle: PAS-004 in Patients With Advanced Solid Tumors overallStatus: RECRUITING date: 2024-02-29 date: 2025-12 date: 2027-02 date: 2024-03-08 date: 2024-03-08 name: Pasithea Therapeutics Corp. class: INDUSTRY briefSummary: The main purpose of this clinical trial is to test PAS-004 in people with advanced solid tumors with rat sarcoma virus (RAS), neurofibromatosis type I (NF1), or rapidly accelerated fibrosarcoma (RAF) mutations. The main questions it aims to answer are:
* How well participants are able tolerate different doses of PAS-004, and
* What side effects PAS-004 might have.
Study participants will have regular visits to the study doctor and be asked to have tests and exams done to check on their health and safety. Everyone participating in the study will take PAS-004 by mouth as a single dose, followed by one week observation, then once a day during the study, in 28-day cycles. Participants will continue on daily PAS-004 for up to 2 years, or until:
* They decide to withdraw from the study, or
* They experience unacceptable side effects, or
* Their disease progresses, or another illness interferes with taking the study drug, or
* The sponsors stops the study. conditions: RAS Mutation conditions: NF1 Mutation conditions: RAF Mutation conditions: Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: 3+3 dose expansion primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: PAS-004 measure: Evaluation of dose limiting toxicities (DLTs) measure: Evaluation of adverse events (AEs) measure: Evaluation of AEs leading to discontinuation of investigational product (IP), PAS-004. measure: Evaluation of hematology laboratory parameters measure: Evaluation of clinical chemistry laboratory parameters measure: Apparent terminal elimination half-life (t1/2) in Plasma measure: Peak Plasma Concentration (Cmax) measure: Plasma predose or trough concentration (Ctau/Ctrough) measure: Time of maximum plasma concentration (Tmax) measure: Area under the concentration versus time curve from time zero to the last sampling time with quantifiable analyte (AUC0-t) measure: Area under the concentration versus time curve from time zero extrapolated to infinity if possible (AUC0-∞) measure: Area under the concentration versus time curve for the dosing interval, assuming steady state has been reached and duplicating the predose concentration for the 24 hour postdose concentration (AUC0-tau) measure: Apparent total plasma clearance if possible (CL/F) measure: Evaluation of the percentage of extracellular signal-regulated kinase phosphorylation (pERK) inhibition from baseline measure: Evaluation of the objective response rate (ORR) measure: Evaluation of progression-free survival (PFS) measure: Evaluation of overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NEXT Oncology status: RECRUITING city: Austin state: Texas zip: 78758 country: United States name: Erica Torres role: CONTACT phone: 210-610-5205 email: etorres@nextoncology.com lat: 30.26715 lon: -97.74306 facility: NEXT Oncology status: RECRUITING city: Irving state: Texas zip: 75039 country: United States name: Erica Torres role: CONTACT phone: 210-610-5205 email: etorres@nextoncology.com lat: 32.81402 lon: -96.94889 facility: NEXT Oncology status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States name: Carmen Gonzalez role: CONTACT phone: 210-580-9521 email: cgonzalez@nextoncology.com lat: 29.42412 lon: -98.49363 facility: NEXT Oncology status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States name: Blake Patterson role: CONTACT phone: 703-783-4505 email: BPatterson@nextoncology.com lat: 38.84622 lon: -77.30637 hasResults: False
<\|newrecord\|> nctId: NCT06299826 id: D9090C00008 briefTitle: A Phase IIb Study of AZD5462 in Patients With Chronic Heart Failure acronym: LUMINARA overallStatus: NOT_YET_RECRUITING date: 2024-06-10 date: 2025-11-24 date: 2025-11-24 date: 2024-03-08 date: 2024-03-08 name: AstraZeneca class: INDUSTRY briefSummary: The main purpose of this study is to evaluate the effect of AZD5462 on cardiac function in participants with chronic heart failure (HF). conditions: Chronic Heart Failure studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 360 type: ESTIMATED name: AZD5462 name: Placebo measure: Cohort A and B: Change from Baseline in Ejection Fraction measure: Cohort A and B: Change from Baseline in Ejection Fraction measure: Cohorts A and B: Change from Baseline in Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS) measure: Cohorts A and B: Change from Baseline in New York Heart Association Functional Class (NYHA FC) measure: Cohorts A and B: Percentage Change from Baseline in cardiac biomarkers measure: Cohorts A and B : Plasma Concentration of AZD5462 measure: Cohorts A and B: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06299813 id: 771.284 id: 2022-002955-20 type: EUDRACT_NUMBER briefTitle: Effectiveness of a Single Dose of Betamethasone in Children With Symptomatic Adenovirus Infection acronym: Adeno-beta overallStatus: RECRUITING date: 2024-03-20 date: 2025-01-15 date: 2026-04-01 date: 2024-03-08 date: 2024-03-21 name: A.O.U. Città della Salute e della Scienza class: OTHER briefSummary: The goal of this double-blind, Placebo-controlled Randomized Study is to assess if a single dose of betamethasone in children with febrile adenoviral infection works well in achieving an early fever regulation.
The experimentation is conducted to answer this question: "Can betamethasone help reduce fever more quickly in a child with viral adenovirus infection? "The secondary objective is to assess if the child's overall clinical conditions improve more rapidly (reduced sore throat, quicker return to regular eating) and a reduction in the incidence and duration of hospitalizations. conditions: Adenovirus studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A double-blind, placebo-controlled randomized study primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The nurse that will prepare and administer the treatment to the patient won't be masked whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Bentelan name: Placebo measure: Proportion of patients with a sustained fever resolution at 24 hours from randomization measure: Pharyngeal-tonsillar pain level in patients younger than 36 months measure: Hospitalization measure: Duration of hospitalization (among those hospitalized), measured in days measure: Cumulative incidence of fever resolution measure: Fever duration measure: Pharyngeal-tonsillar pain level in patients older than 36 months sex: ALL minimumAge: 6 Months maximumAge: 6 Years stdAges: CHILD facility: Ospedale Infantile Regina Margherita status: RECRUITING city: Torino zip: 10126 country: Italy name: Virginia Giannone, MD role: CONTACT phone: +390113135063 email: vgiannone@cittadellasalute.to.it name: Marco Denina, MD role: CONTACT phone: +390113135064 email: mdenina@cittadellasalute.to.it name: Emanuele castagno, MD role: SUB_INVESTIGATOR name: Giannone Virginia, MD role: SUB_INVESTIGATOR name: Marco Denina, MD role: SUB_INVESTIGATOR lat: 45.07049 lon: 7.68682 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-06-12 uploadDate: 2023-12-06T05:08 filename: Prot_SAP_000.pdf size: 963093 hasResults: False
<\|newrecord\|> nctId: NCT06299800 id: CE385/2023 briefTitle: Phenotyping Patients With Type 2 Diabetes Mellitus and Cancer acronym: TCPT2023 overallStatus: RECRUITING date: 2024-02-04 date: 2025-02-04 date: 2025-02-04 date: 2024-03-08 date: 2024-03-08 name: Azienda Ospedaliero Universitaria Maggiore della Carita class: OTHER briefSummary: Recent research has highlighted the significant relationship between type 2 diabetes mellitus and cancer, both prevalent and impactful on global health. The intrinsic correlation arises from shared metabolic processes, particularly a systemic and chronic inflammatory state driven by factors like obesity, dyslipidemia, and hyperglycemia. This leads to the creation of a self-sustaining microenvironment known as meta-inflammation, promoting cancer development through DNA damage, oxidative stress, and the influence of hormones like leptin. The hyperglycemic environment in diabetes contributes to cancer development, supporting the Warburg effect and insulin-related mechanisms. This study aims to identify risk factors associated with diabetes that impact tumor development and progression, crucial for guiding effective preventive strategies in clinical practice.
Primary objective of the study:
- identify the risk factors affecting the occurrence of cancer in the population affected by type 2 diabetes mellitus;
Secondary objectives of the study:
* description of the demographic, clinical and first-line therapy characteristics of patients diagnosed with type 2 diabetes mellitus;
* assess risk factors for recurrence, presence of a second tumour not related to the first and the presence of both events in patients who have had a tumor within 10 years of diagnosis of diabetes;
* assess the relationship between the characteristics of patients and the time to the onset of cancer. conditions: Diabetes Mellitus, Type 2 conditions: Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 779 type: ESTIMATED name: phenotyping of patients followed at a third-level diabetes centre with cancer measure: Smoking assessment at first visit measure: Alcool consumption at first visit measure: BMI assessment at first visit measure: Glycated assessment at first visit measure: First-line therapy characteristics assessment at first visit measure: Primary outcomes and recurrence or presence of a secondary tumor measure: Relationship between patients characteristics and the time onset of cancer considering anthropometric and biochemical data measure: Tumour characterization in the considered population, detected at the first clinical visit sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SCDU Endocrinology, AOU Ospedale Maggiore della Carità status: RECRUITING city: Novara zip: 28100 country: Italy name: Flavia Prodam role: CONTACT phone: +39 0321 660 693 email: flavia.prodam@med.uniupo.it lat: 45.44694 lon: 8.62118 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-09-10 uploadDate: 2024-03-01T05:46 filename: Prot_SAP_000.pdf size: 525402 hasResults: False
<\|newrecord\|> nctId: NCT06299787 id: 058-2021 briefTitle: Cognitive Dysfunction in the Addictions Study - Project 4 (P4) acronym: CDiA-P4 overallStatus: RECRUITING date: 2022-02-07 date: 2024-12-31 date: 2025-07-01 date: 2024-03-08 date: 2024-03-08 name: Centre for Addiction and Mental Health class: OTHER briefSummary: The prefrontal cortex, although well established as an efficacious target for the treatment of major depressive disorder (MDD), has recently come into favour as a therapeutic target for alcohol use disorders (AUD). Depressive symptoms are also highly prevalent in individuals with AUD. A number of cognitive and psychological processes stemming from the prefrontal cortex, a common treatment target for repetitive transcranial magnetic stimulation (rTMS), are disrupted in both MDD and AUD. The proposed study will enhance the development of theta burst stimulation (TBS) as a new intervention for AUD in the context of depressive symptoms and uses integrated TMS-EEG to identify neurophysiological targets of executive dysfunction in this disorder. conditions: Major Depressive Disorder conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: intermittent theta burst stimulation name: Sham stimulation measure: Executive Function Index - inhibition measure: Executive Function Index - working memory measure: Executive Function Index - set shifting measure: 17-Item Hamilton Depression Rating Scale (HRSD-17) measure: Columbia-Suicide Severity Rating Scale sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: Centre for Addiction and Mental Health status: RECRUITING city: Toronto state: Ontario zip: M6J 1H4 country: Canada name: Daphne Voineskos, MD role: CONTACT phone: 416-535-8501 phoneExt: 30176 email: daphne.voineskos@camh.ca lat: 43.70011 lon: -79.4163 hasResults: False
<\|newrecord\|> nctId: NCT06299774 id: 2023P003383 briefTitle: Emergency Care at Home overallStatus: RECRUITING date: 2024-02-02 date: 2025-02-02 date: 2025-03-02 date: 2024-03-08 date: 2024-03-08 name: Brigham and Women's Hospital class: OTHER briefSummary: This study will assess the efficacy of receiving emergency care at home versus in the brick-and-mortar emergency department. conditions: Emergency Medical Services conditions: Emergency Department Visits studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1500 type: ESTIMATED name: Emergency care at home name: Emergency care at a brick-and-mortar emergency department measure: Participant with an emergency department presentation, observation, or hospitalization within 9 days measure: Time to care initiation measure: Time spent receiving care measure: Number of days at home within 9 days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: David Levine, MD, MPH, MA role: CONTACT phone: 617-732-7063 email: dmlevine@bwh.harvard.edu lat: 42.35843 lon: -71.05977 hasResults: False
<\|newrecord\|> nctId: NCT06299761 id: BBI-825-101 briefTitle: Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications acronym: STARMAP overallStatus: RECRUITING date: 2024-03-28 date: 2027-02 date: 2027-02 date: 2024-03-08 date: 2024-04-29 name: Boundless Bio class: INDUSTRY briefSummary: BBI-825 is a potent, selective, oral, small molecule inhibitor of ribonucleotide reductase (RNR). This is a first-in-human, open-label, non-randomized, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-825 administered as a single agent and in combination with select targeted therapies. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: BBI-825 single agent dose escalation primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: BBI-825 measure: Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-825 measure: Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of BBI-825 measure: Maximum observed plasma concentration (Cmax) of BBI-825 measure: Trough observed plasma concentration (Ctrough) of BBI-825 measure: Time to Cmax (Tmax) of BBI-825 measure: Area under the concentration time curve (AUC) of BBI-825 measure: Anti-tumor activity of BBI-825 as determined by RECISTv1.1 sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sarcoma Oncology Research Center status: RECRUITING city: Santa Monica state: California zip: 90403 country: United States lat: 34.01945 lon: -118.49119 facility: START Midwest status: RECRUITING city: Grand Rapids state: Michigan zip: 49546 country: United States lat: 42.96336 lon: -85.66809 facility: NEXT Oncology status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States lat: 29.42412 lon: -98.49363 hasResults: False
<\|newrecord\|> nctId: NCT06299748 id: ARGX-113-PAC-2206 briefTitle: A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding. overallStatus: NOT_YET_RECRUITING date: 2024-02-29 date: 2033-12 date: 2033-12 date: 2024-03-08 date: 2024-03-08 name: argenx class: INDUSTRY briefSummary: This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries/regions as the countries/regions in which the VYVGART IV or SC-exposed pregnancies were reported. conditions: Myasthenia Gravis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 279 type: ESTIMATED name: Efgartigimod measure: Pregnancy outcomes measure: Congenital malformations measure: The number of observed other events of interest in the developing neonate and infant (such as hospitalizations for serious illness) measure: Maternal complications of pregnancy measure: Maternal infections measure: The number of observed fetal growth deficiency sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06299735 id: AsenaIremYildiz1 briefTitle: Comparison of Airway Management With Bronchial Blocker and Double-Lumen Tube in Single-Lung Ventilation overallStatus: RECRUITING date: 2024-02-01 date: 2024-08-31 date: 2024-09-30 date: 2024-03-08 date: 2024-04-17 name: Ankara City Hospital Bilkent class: OTHER briefSummary: In this study, the primary aim is to compare the impact of using a double-lumen tube and bronchial blocker for single-lung ventilation in patients undergoing minimal invasive cardiac surgeries on postoperative pulmonary functions. Secondary objectives include the comparison of application duration, success in lung collapse, and the number of repositioning attempts for both techniques. conditions: Heart Valvular Disease conditions: Coronary Arteriosclerosis conditions: One-lung Ventilation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The anesthesia method applied for both patient groups is the same. However, the airway maintenance device used will vary between two different patient groups. Group BB: A bronchial blocker will be used for this patient group, Group DLT: A double-lumen tube will be used for this patient group. The parameters to be recorded for both patient groups include: preoperative smoking history, ARISCAT score, systolic arterial pressure, diastolic arterial pressure, saturation, pulse, and the duration of airway device insertion following anesthesia induction and intubation. For the assessment of postoperative pulmonary complications in both patient groups, arterial blood gas analysis, chest X-ray, respiratory sounds, and the patient's oxygen requirement will be monitored every 6 hours for 24 hours. primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 66 type: ESTIMATED name: Minimally Invasive Cardiac Surgery (airway management with double-lumen tube) name: Minimally Invasive Cardiac Surgery (airway management with endobronchial blocker) measure: Comparison of Postoperative Pulmonary Complications in Patient Groups Undergoing Single-Lung Ventilation with Double-Lumen Tube and Bronchial Blocker measure: Duration of insertion of the double-lumen tube / bronchial blocker measure: Incidence of postoperative sore throat measure: Incidence of postoperative hoarseness measure: Impact of the success of lung collapse measure: Satisfactory lung collapse time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara bilkent city hospital status: RECRUITING city: Ankara state: Çankaya zip: 06530 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06299722 id: N-20230055 briefTitle: Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents acronym: STEEL overallStatus: RECRUITING date: 2024-03-15 date: 2025-07 date: 2025-07 date: 2024-03-08 date: 2024-03-19 name: Aalborg University class: OTHER briefSummary: We aim to include 60 children and adolescents aged 10 to 19 years who have undergone successful treatment for leukemia or lymphoma. Based on randomization, they will either 1) commence 16 weeks of training with STEEL or 2) commence 16 weeks of circuit training. STEEL training involves exercises for major muscle groups using free weights, body weight, or tailored machines. Circuit training is structured similarly to previous training for the target group and includes exercises using body weight, exercise balls, and rings. The training takes place in local centers either with friends or with other participants in the project. Before starting participation in the project, the child/adolescent and their parents or guardians will receive information about late effects, diet, sleep, and exercise, providing guidance and support regarding the project elements. The effects of the two training modalities will be evaluated based on self-reported quality of life, muscle strength, muscle mass, bone mineral content, fitness, and markers of metabolic syndrome (BMI, waist circumference, blood pressure, and blood analysis). conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: STEEL name: Circuit training measure: Isometric strength measure: Health-related quality of life measure: Step counts measure: Caloric expenditure measure: Maximal dynamic strength measure: Bone mineral density of the lumbar spine and body composition measure: Grip strength and rate of force development measure: Muscular strength, endurance, and rate of force development measure: Cardiorespiratory fitness and endurance measure: Exercise compliance and fidelity measure: Adverse events measure: Movement-evoked pain measure: Satisfaction with the intervention measure: Blood glucose measure: Glycated hemoglobin (Hba1c) measure: Insulin measure: Proinsulin c-peptide measure: Total cholesterol measure: High-density lipoprotein cholesterol measure: Low-density lipoprotein cholesterol measure: Very low-density lipoprotein cholesterol measure: Triglycerides measure: Glucagon measure: Homeostatic Model assessment for Insulin resistance score measure: Body Mass Index (BMI) measure: Lean body mass measure: Fat mass measure: Android/gynoid fat distribution measure: Abdominal circumference measure: Self-reported Tanner staging measure: Blood pressure sex: ALL minimumAge: 10 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: Rigshospitalet status: RECRUITING city: Copenhagen country: Denmark name: Martin K Fridh role: CONTACT email: martin.kaj.fridh@regionh.dk lat: 55.67594 lon: 12.56553 facility: Aalborg University status: RECRUITING city: Gistrup zip: 9260 country: Denmark name: Henrik Riel role: CONTACT email: hriel@dcm.aau.dk lat: 56.9943 lon: 9.99085 facility: Odense University Hospital status: RECRUITING city: Odense country: Denmark name: Mathias Rathe role: CONTACT email: mathias.rathe@rsyd.dk lat: 55.39594 lon: 10.38831 facility: Århus University Hospital status: RECRUITING city: Århus country: Denmark name: Clara Vad role: CONTACT email: claravad@live.dk lat: 56.15674 lon: 10.21076 hasResults: False
<\|newrecord\|> nctId: NCT06299709 id: VX23-121-012 briefTitle: A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA) overallStatus: RECRUITING date: 2024-03-13 date: 2024-06 date: 2024-06 date: 2024-03-08 date: 2024-04-01 name: Vertex Pharmaceuticals Incorporated class: INDUSTRY briefSummary: The purpose of this study is to evaluate the relative bioavailability, food effect, and dose proportionality of a granule formulation of VNZ/TEZ/D-IVA. conditions: Cystic Fibrosis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 34 type: ESTIMATED name: VNZ/TEZ/D-IVA name: VNZ/TEZ/D-IVA measure: Part A: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA measure: Part B: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA measure: Part A: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA measure: Part B: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA measure: Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Celerion, Inc. status: RECRUITING city: Tempe state: Arizona zip: 85283 country: United States lat: 33.41477 lon: -111.90931 hasResults: False
<\|newrecord\|> nctId: NCT06299696 id: VX23-121-011 briefTitle: A Study of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) in Healthy Adult Panelists overallStatus: ENROLLING_BY_INVITATION date: 2024-03-26 date: 2024-05 date: 2024-05 date: 2024-03-08 date: 2024-04-08 name: Vertex Pharmaceuticals Incorporated class: INDUSTRY briefSummary: The purpose of this study is to evaluate the flavor (basic tastes, aroma, texture, mouthfeel) of VNZ/TEZ/D-IVA fixed dose combination (FDC) granules. conditions: Cystic Fibrosis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ESTIMATED name: VNZ/TEZ/D-IVA measure: Flavor Assessment Based on Flavor Profile Method of Descriptive Sensory Analysis per American Society for Testing and Material (ASTM) Approved Sensory Evaluation Method sex: ALL minimumAge: 25 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Site 001 city: Woburn state: Massachusetts zip: 01801 country: United States lat: 42.47926 lon: -71.15228 hasResults: False
<\|newrecord\|> nctId: NCT06299683 id: 230487 id: 1R01DK133415-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R01DK133415-01A1 briefTitle: Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-04-05 date: 2028-08-04 date: 2024-03-08 date: 2024-03-08 name: Vanderbilt University Medical Center class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe pain condition affecting 3-8 million people in the United States lacking treatments that work. Emotional suffering is common in IC/BPS and known to make physical symptoms worse, and studies show patient sub-groups respond differently to treatment. Individuals with IC/BPS have distinct subgroups, or "phenotypes," largely characterized by the distribution of pain throughout the body. Supported by our preliminary evidence, the overall goal of this project is to assess how IC/BPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC/BPS. conditions: Chronic Interstitial Cystitis conditions: Bladder Pain Syndrome conditions: Painful Bladder Syndrome conditions: Cystitis, Interstitial conditions: Cystitis, Chronic Interstitial conditions: Interstitial Cystitis conditions: Interstitial Cystitis, Chronic conditions: Interstitial Cystitis (Chronic) With Hematuria conditions: Interstitial Cystitis (Chronic) Without Hematuria conditions: Chronic Prostatitis conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study involves a two group parallel design, with one group receiving individual psychosocial intervention online and another pelvic floor physical therapy. primaryPurpose: TREATMENT masking: NONE maskingDescription: Study assessors will be blinded to the study primary outcome but will be aware of study treatment conditions. count: 220 type: ESTIMATED name: Psychosocial Treatment name: Pelvic Floor Physical Therapy measure: Differences in response to treatment by phenotype measured by the Global Response Assessment (GRA) scale. measure: Chronic Overlapping Pain Condition-Screener (COPCS) measure: Quantitative Sensory Testing - Tolerance Average (QST-TOL) measure: Quantitative Sensory Testing - Threshold Average (QST-THR) measure: Quantitative Sensory Testing - Temporal Summation (QST-TS) measure: Urinary Nerve Growth Factor (NGF) measure: Urinary Interleukin-6 (IL6) measure: Interleukin-6, whole blood stimulated (IL6-LPS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06299670 id: 939 briefTitle: Efficacy of Combination of Hdroxyurea and Thalidomide Over Either Hydroxyurea or Thalidomide Alone in the Treatment of Transfusion Dependent Thalassemia in Children: A Quasi-Randomised Clinical Trial overallStatus: RECRUITING date: 2023-11-01 date: 2024-06-30 date: 2024-12-31 date: 2024-03-08 date: 2024-03-08 name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh class: OTHER briefSummary: Transfusion Dependent Thalassemia (TDT) is an emerging global public health concern. Hemopoietic stem cell transplantation (HSCT) is the only curative treatment. But its adoption is limited due to lack of HLA matched donor, experienced centers and high initial cost. So, researches are going on in search of an effective, safe, easily available treatment option. Use of fetal haemoglobin inducing agents shows promising effects in treatment of TDT patients. Thalidomide an immunomodulating and anti-angiogenic drug has been shown to induce γ-globin gene expression and increase the proliferation of erythroid cells. Furthermore Hydroxyurea (HU) is known to increase haemoglobin (Hb) by HbF induction and reduction of inflammation and hypercoagulability.
Recent studies with combination of HU and Thalidomide have shown promising results in treatment of Thalassemia patients. However, most of those studies are retrospective or single arm nonrandomized trials \& The study population includes both adult and children age group . So the effectiveness of combination therapy of Thalidomide and HU needs to be established through randomized trials.
This single centered non blinded quasi randomized clinical trial will be conducted at the Department of Pediatric Hematology and Oncology in Bangabandhu Sheikh Mujib Medical University (BSMMU), Bangladesh for one year of period. Thirty transfusion dependent thalassemia children of 3-18 years old will be included in each group. The objective of this study is to assess the effectiveness of combination of Thalidomide and Hydroxyurea in TDT children. It will play an important role in planning a cost effective and affordable treatment option for TDT children.This study will involve minimum physical risk to the patient. Written informed consent will be taken from parents or study subjects after brief explanation of the purpose and procedure. They will also be informed about the freedom to participate or not to participate at any time. Privacy and confidentiality will be safe guarded. History regarding age, sex, height, weight of these patients will be taken. Thorough physical examinations and laboratory investigations including CBC, Hb electrophoresis, serum Ferritin, serum creatinine, SGPT will be done. Data will be collected in a predesigned questionnaire and will be kept confidential. Statistical analysis will be done using the statistical software SPSS. conditions: Transfusion-dependent Thalassemia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 90 type: ESTIMATED name: Thalidomide name: Hydroxy Urea name: Combinations measure: Change in Hb Level measure: Change in Blood transfusion frequency measure: Change in HbF measure: Change in Biochemicals measure: Adverse effect sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Bangabandhu Sheikh Mujib Medical University status: RECRUITING city: Dhaka zip: 1000 country: Bangladesh name: Md. Anwarul Karim, MBBS, FCPS, MD role: CONTACT phone: +880255165814 email: drkarim1990@gmail.com lat: 23.7104 lon: 90.40744 hasResults: False
<\|newrecord\|> nctId: NCT06299657 id: 2023H0286 briefTitle: Intervention for Managing Physical Reactions to Overwhelming Emotions acronym: IMPROVE overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-03 date: 2024-03-08 date: 2024-03-08 name: Ohio State University class: OTHER briefSummary: The clinical trial aims to conduct a feasibility, acceptability, and usability clinical trial of a modular CBT-based and technologically enhanced intervention for people with an SUD and recently enrolled in IOP, probe target engagement and change in clinical outcomes, and examine attrition rates in IOP.
This study will enroll 40 adults who are currently enrolled in IOP, have a substance use disorder, and experience elevated anxiety. 20 individuals will be randomized to the experimental intervention, "Intervention for Managing Physical Reactions to Overwhelming Emotions" (IMPROVE), and 20 individuals will be randomized to the active control group, "Physical Health Education Treatment" (PHET).
Participants will be asked to complete a baseline assessment of mood, substance use, and psychophysiology. Participants will then completed ecological momentary assessments (EMA) via smartphone technology 4 times a day for \~ 28 days (the day following the baseline assessment until the 3rd intervention session). Participants will complete one 45 minute - 1 hour intervention each week for 3 weeks (either the IMPROVE or PHET intervention, pending randomization). Following the last intervention session, participants will return to the lab to complete a post-intervention assessment that mirrors the baseline assessment and then complete follow-up surveys 1- and 3-months post intervention. conditions: Anxiety conditions: Substance Use Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to receive one of two possible interventions. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Raters completing the outcome assessments will be blind to condition. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: IMPROVE name: PHET measure: Intolerance of Uncertainty-12 Scale measure: Anxiety Sensitivity-3 Scale measure: PROMIS Anxiety Short Form measure: Timeline Followback measure: Desire for Drug Questionnaire measure: Penn Alcohol Craving Scale measure: Hyperkatifeia Interference Scale - Alcohol Version. measure: Clinical Institute Withdrawal Assessment Alcohol Scale Revised. measure: Hyperkatifeia Interference Scale - Opioid Version. measure: Subjective Opiate Withdrawal Scale measure: NPU Threat Task measure: Straw Breathing Avoidance Task measure: Emotion Picture Paradigm Task sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio State University Department of Psychiatry and Behavioral Health city: Columbus state: Ohio zip: 43062 country: United States name: Nicholas P Allan, PhD role: CONTACT lat: 39.96118 lon: -82.99879 hasResults: False

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