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<\|newrecord\|> nctId: NCT06297915 id: 2022/08-45 briefTitle: Infusion Treatments of Chronic Peripheral Neuropathic Pain overallStatus: COMPLETED date: 2022-05-17 date: 2023-05-10 date: 2023-08-01 date: 2024-03-07 date: 2024-03-07 name: Hacettepe University class: OTHER briefSummary: This study aimed to evaluate and compare the efficacy of ketamine and lidocaine infusion in patients with chronic peripheral neuropathic pain.
Patients who received intravenous ketamine infusion and the other patient group who received intravenous lidocaine infusion were evaluated in the study. Pain scores and quality of life were assessed with scales before treatment at two weeks, two months, and six months after treatment. conditions: Neuropathic Pain studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: RETROSPECTIVE count: 102 type: ACTUAL name: Ketamine name: Lidocain measure: Neuropathic Pain Scale measure: Pain Rating Scale measure: Quality of Life Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hacettepe University city: Ankara state: Cankaya zip: 06360 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06297902 id: 2023_31 briefTitle: RAdiotherapy With FDG-PET Guided Dose-PAINTing Compared With Standard Radiotherapy for Primary Head and Neck Cancer-3 acronym: RADPAINT-3 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-06 date: 2030-06 date: 2024-03-07 date: 2024-03-07 name: Oslo University Hospital class: OTHER name: Haukeland University Hospital name: St. Olavs Hospital name: Norwegian University of Life Sciences briefSummary: The objective of the RADPAINT-3 trial is to investigate whether dose painting is safe compared to standard radiotherapy. RADPAINT-3 is a randomized, non-inferiority, multi-center phase II study, initiated at the Section for Head and Neck Cancer, Department of Oncology, Oslo University Hospital, accruing from first half of 2024. The primary endpoint is frequency of grade ≥ 3 (CTCAE v5.0) mucosal ulcers one year after treatment. The expected inclusion period is three years, total study duration is six years and planned inclusion number is 100 patients. The collaborating sites are St Olav´s Hospital and Haukeland University Hospital. The patients will be randomized 1:1 to either standard radiotherapy (2 Gy x 34; total dose 68 Gy) or experimental radiotherapy (dose painting). All patients will have 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission computed tomography (FDG-PET/CT) prior to radiotherapy. In the experimental arm, we will escalate the dose to the hypermetabolic part of the tumor (maximum point dose 83.3 Gy), shown in pre-treatment FDG-PET images. Dose escalation will be applied to these regions during the first half of the fractionated treatment (17 of 34 fractions). The patients in both arms will receive concomitant nimorazole (hypoxic radiosensitizer) and concomitant cisplatin if indicated according to standard treatment. The main inclusion criterion is patients with human-papillomavirus (HPV)-unrelated head and neck cancer with poor prognosis.
The RADPAINT-3 trial includes a translational sub-study where we aim to elucidate underlying mechanisms related to the radiotherapy effect, by investigating blood samples. Analysis of cytokines in repetitive blood samples may predict both tumor response and toxicity. The data derived from this sub-study, will be further explored using artificial intelligence.
If RADPAINT-3 shows that there is no excess toxicity, we will continue the study after a new protocol has been approved. The new primary endpoint will be local control at 1 year after radiotherapy. Power analysis show that we will need in total 182 evaluable patients including the 100 patients from RADPAINT-3. The translational sub-study will then be extended to investigate genetic expression data from pre-therapy routine tumor biopsies and correlate this with the analysis of blood samples and tumor control. conditions: Head and Neck Cancer conditions: Radiotherapy Side Effect studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Dose painting measure: Late mucosal ulcer measure: Early toxicity measure: Late toxicity measure: Odynophagia measure: Health-related quality of life measure: Cytokines sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06297889 id: Ma Hucheng briefTitle: Effect of Core Strength Training on the Physical Fitness and Skills of Youth Field Hockey Players in China overallStatus: RECRUITING date: 2024-02-15 date: 2024-06-01 date: 2024-06-15 date: 2024-03-07 date: 2024-03-08 name: Universiti Putra Malaysia class: OTHER briefSummary: Hockey, tracing its origins back to 2000 BC, has undergone substantial evolutionary transformations throughout the centuries. Initially known by various names, the game transitioned to its modern form approximately 50 years ago, when matches were conducted on grass fields with wooden sticks. In contemporary international hockey, there has been a notable shift towards artificial grass, cultivating a dynamic and fast-paced game that places heightened demands on individual skills, tactical acumen, and physical fitness. This evolution reflects a continuous adaptation, seamlessly blending tradition with cutting-edge equipment and hybrid playing grounds.
Against this backdrop, modern-day hockey programs have metamorphosed into rigorous and demanding training regimes. Athletes engaged in these programs are required not only to demonstrate outstanding physical fitness but also exhibit a high level of proficiency in the nuanced skills essential for competitive play. As hockey continues its progressive trajectory, athletes partaking in these programs must meet elevated standards, underscoring the imperative integration of both exceptional fitness levels and precise skill execution.
Despite the growing emphasis on the physical and skill dimensions of hockey, a literature review uncovered a dearth of research specifically focusing on core strength training for hockey players. While core strength training has demonstrated efficacy in improving physical fitness and skill performance among athletes in other team sports, its applicability to hockey players remains underexplored. Moreover, no studies have systematically examined the impact of core strength training on the two critical variables of physical fitness and skill performance in hockey players.
To address this research gap, the present study sought to investigate the effects of core strength training on the physical fitness and skill performance of youth hockey players in Gansu Province, China. By doing so, this study not only contributes valuable insights to the existing body of literature but also furnishes theoretical support for the development of hockey sport programs. The findings are anticipated to inform targeted interventions aimed at enhancing athletes' physical fitness and skill performance, ultimately fostering the progression of hockey programs within the sporting landscape of China. conditions: Player studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: In this experiment, the experimental group engaged in the core strength training segment of the intervention specifically devised for this study, whereas the control group underwent conventional strength training activities. primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: core strength training 1-6weeks name: core strength training 7-12weeks measure: Power test measure: Speed test sex: MALE minimumAge: 15 Years maximumAge: 17 Years stdAges: CHILD facility: Ma Hucheng status: RECRUITING city: Lanzhou state: Gansu zip: 730000 country: China name: Hucheng Ma, PHD role: CONTACT phone: +8613909492013 email: 875803848@qq.com name: WEI WEI, Senior Coach role: CONTACT phone: +8618919171585 email: 3371189581@qq.com lat: 36.05701 lon: 103.83987 hasResults: False
<\|newrecord\|> nctId: NCT06297876 id: H00023815 briefTitle: COVIDVaxStories: Randomized Trial to Reduce COVID-19 Vaccine Hesitancy in Populations of Color overallStatus: RECRUITING date: 2023-05-19 date: 2024-05 date: 2025-05 date: 2024-03-07 date: 2024-03-07 name: University of Massachusetts, Worcester class: OTHER name: Merck Sharp & Dohme LLC briefSummary: Pilot randomized controlled trial testing the investigator's previously developed storytelling method to create an interactive, multi-media storytelling intervention to address community-identified reasons for vaccine hesitancy among Black and Hispanic individuals in Central Massachusetts conditions: Vaccine Hesitancy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: SINGLE maskingDescription: Participants will view either storytelling videos or learn more videos. They will not know which video they will get ahead of time nor will they know that they may get one or the other. whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: Storytelling name: Learn More (Active Comparator) measure: Change in Vaccine Hesitancy measure: Vaccine Uptake sex: ALL minimumAge: 18 Years maximumAge: 105 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Massachusetts Chan Medical School status: RECRUITING city: Worcester state: Massachusetts zip: 01605 country: United States name: Sarah Forrester, PhD role: CONTACT phone: 508-856-8338 email: sarah.forrester@umassmed.edu name: Jeroan Allison, MD role: CONTACT phone: 5088568993 email: jeroanallison@umassed.edu lat: 42.26259 lon: -71.80229 hasResults: False
<\|newrecord\|> nctId: NCT06297863 id: DOWN-SUITE briefTitle: Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke acronym: DOWN-SUITE overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2026-09-30 date: 2026-12-31 date: 2024-03-07 date: 2024-03-07 name: University of Milano Bicocca class: OTHER name: Fondazione IRCCS San Gerardo dei Tintori name: Azienda Ospedaliero-Universitaria Careggi, Firenze name: Azienda Ospedaliera Universitaria Gaetano Martino, Messina briefSummary: The DOWN-SUITE study is multicenter, randomised, controlled, open-label clinical trial with blinded outcome assessment comparing collateral status in patients with acute ischemic stroke treated with an in-hospital application of head down tilt -10° to -15° (HDT15) versus usual positioning (0° to +30°) before endovascular mechanical thrombectomy.
This study will involve adult patients who are eligible for mechanical thrombectomy and who have acute ischemic stroke due to left or right middle cerebral artery occlusion (M1 segment).
The investigators hypothesise that HDT15, applied in acute ischemic stroke patients with a large vessel occlusion, will improve collateral circulation, prolong the survival of the ischemic penumbra and improve the clinical benefit from mechanical thrombectomy compared with standard of care (usual positioning 0° to +30°). conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The DOWN-SUITE trial is a prospective, multicenter, proof of concept, randomised, controlled, open label, phase 2a/b clinical trial with blinded outcome assessment, comparing cerebral collateral status in patients with acute ischemic stroke due to middle cerebral artery occlusion (M1 segment) treated with in-hospital application of HDT15 (-10° to -15°) versus usual positioning (0° to +30°), before and during mechanical thrombectomy. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: A blinded central imaging core lab, whose members will be unaware of the procedure assignments, will assess all imaging outcomes, including the primary efficacy outcome (collateral status, assessed during the pretreatment diagnostic angiographic series of mechanical thrombectomy) whoMasked: OUTCOMES_ASSESSOR count: 118 type: ESTIMATED name: HEAD DOWN TILT -10° to -15° measure: Good collateral status measure: Feasibility of HDT15 measure: Delay to thrombectomy measure: Vomiting measure: Early neurological deterioration measure: Symptomatic intracranial hemorrhage measure: Aspiration pneumonia measure: Neurological disability measure: Systolic blood pressure measure: Diastolic blood pressure measure: Oxygen saturation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06297850 id: WARD-Glucose Validation v.2.2 briefTitle: Accuracy of Continuous Glucose Monitoring in Patients With Diabetes. A Prospective Observational Study overallStatus: RECRUITING date: 2024-04-01 date: 2024-09-30 date: 2025-05-01 date: 2024-03-07 date: 2024-04-12 name: University Hospital Bispebjerg and Frederiksberg class: OTHER name: Rigshospitalet, Denmark name: Steno Diabetes Center Copenhagen name: Zealand University Hospital briefSummary: The goal of this observational study is to investigate the accuracy of the continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in patients with diabetes in patients who during their hospital admission can experience circulatory impairment.
The main questions it aims to answer are:
• Do CGM measurements have a decreased accuracy compared to standard blood glucose measurements in periods with circulatory impairment?
Participants will be asked to wear a blinded CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital but will receive standard care of their diabetes. The CGM device will be worn for up to 10 days. conditions: Diabetes Mellitus conditions: Dysglycemia conditions: Perioperative Complication conditions: Circulatory; Complications studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7) measure: Agreement between glucose measure: Agreement between glucose readings when at low glucose levels measure: Agreement between glucose readings when at normal glucose levels measure: Agreement between glucose readings when at high glucose levels measure: Adverse clinical outcomes measure: Readmission measure: Mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet status: RECRUITING city: Copenhagen state: The Capital Region Of Denmark zip: 2100 country: Denmark name: Eske K Aasvang, MD, DMSc role: CONTACT email: eske.kvanner.aasvang.01@regionh.dk lat: 55.67594 lon: 12.56553 facility: Department of Anaesthesiology and Intensive Care, Bispebjerg Hospital status: RECRUITING city: Copenhagen state: The Capital Region Of Denmark zip: 2400 country: Denmark name: Christian S Meyhoff, MD, PhD role: CONTACT email: christian.sylvest.meyhoff@regionh.dk lat: 55.67594 lon: 12.56553 facility: Department of Orthopaedic Surgery and Traumatology, Bispebjerg and Frederiksberg Hospital status: RECRUITING city: Copenhagen state: The Capital Region Of Denmark zip: 2400 country: Denmark name: Henrik Palm, MD, DMSc role: CONTACT email: henrik.palm@regionh.dk lat: 55.67594 lon: 12.56553 facility: Surgical department, Bispebjerg and Frederiksberg Hospital, status: NOT_YET_RECRUITING city: Copenhagen state: The Capital Region Of Denmark zip: 2400 country: Denmark name: Lars N Jørgensen, MD, DMSc role: CONTACT email: lars.nannestad.joergensen@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False
<\|newrecord\|> nctId: NCT06297837 id: LHS0205 briefTitle: ADAPT-AST (Adaptive Antimicrobial Susceptibility Testing) acronym: ADAPT-AST overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2026-03 date: 2024-03-07 date: 2024-03-07 name: Liverpool University Hospitals NHS Foundation Trust class: OTHER_GOV briefSummary: The goal of this study is to improve the way urinary tract infections (UTIs) are tested for antibiotic resistance. The main questions it aims to answer are:
* Can the investigators use a method called Bayesian causal inference to create or check clinical prediction models that help predict if certain antibiotics will work for a urinary infection, using patient information from the National Health Service (NHS)?
* Can this new ADAPT-AST method, which uses data and a smarter approach, do a better job of testing for urinary infection than the old methods? Will it help doctors make quicker decisions and save resources by being more efficient?
Participants in this study will not be receiving treatments. The study will involve:
Using statistical methods to predict UTI test results based on patient data. Evaluating whether this new approach can provide doctors with more timely and useful information for treating UTIs.
Assessing whether it can help save money and resources in the lab and pharmacy. conditions: Urinary Tract Infections studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 500000 type: ESTIMATED measure: The number of antimicrobial susceptibility results that 'should' spur action by a clinician on measure: The number of days until a result that 'should' spur action by a clinician measure: The number of antimicrobial susceptibility results that 'could' spur action by a clinician on measure: The number of days until a result that 'could' spur action by a clinician measure: The projected health economic cost per specimen, including laboratory (e.g., consumable cost) and patient (e.g., drug toxicity, clinical failure) measures. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_ICF hasProtocol: True hasSap: False hasIcf: True label: Study Protocol and Informed Consent Form date: 2023-10-03 uploadDate: 2023-11-16T04:00 filename: Prot_ICF_000.pdf size: 2230025 hasResults: False
<\|newrecord\|> nctId: NCT06297824 id: 2023-04909-01 briefTitle: Feasibility of Emotion Regulation Group Therapy for Adolescent Self-Harm acronym: ERGT-A overallStatus: RECRUITING date: 2023-10-10 date: 2024-12-31 date: 2025-06-30 date: 2024-03-07 date: 2024-03-07 name: Karolinska Institutet class: OTHER briefSummary: Deliberate self-harm (DSH) is a prevalent behaviour among adolescents but there is no current recommendation for an efficacious treatment. Emotion regulation group therapy (ERGT) is a brief treatment for DSH with a well-documented utility and feasibility in the adult population, and an adapted version for adolescents may provide equal benefits for adolescents, provided adjustments to prevent or decrease social contagion are present.
A quantitative feasibility open trial (N=20) followed up by a qualitative interview study will examine the feasibility, acceptability and preliminary effect of ERGT for adolescents. conditions: Self-harm conditions: Emotion Regulation conditions: Adolescent - Emotional Problem studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Feasibility, open trial primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: ERGT-A measure: Feasibility measure, recruitment rate measure: Feasibility measures, proportion included measure: Feasibility measures, compliance measure: Feasibility measures, attrition measure: Feasibility measures, client satisfaction measure: Feasibility measures, negative effects of treatment measure: Preliminary effect, self harm frequency EOT measure: Preliminary effect, self harm frequency 1MFU measure: Preliminary effect, emotion dysregulation EOT measure: Preliminary effect, emotion dysregulation 1MFU sex: ALL minimumAge: 13 Years maximumAge: 17 Years stdAges: CHILD facility: Prima Barn och Vuxenpsykiatri Handen och Järva status: RECRUITING city: Stockholm state: Spånga zip: 16374 country: Sweden name: Dimitar Krastev, MSc role: CONTACT phone: +46735269516 email: Dimitar.Krastev@prima.se name: MaiBritt Giacobini, PhD role: CONTACT phone: +46709736662 email: Maibritt.Giacobini@prima.se lat: 59.33258 lon: 18.0649 hasResults: False
<\|newrecord\|> nctId: NCT06297811 id: SMA PT 001 briefTitle: Myeloprotection With Trilaciclib in Pan-cancer Population overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-09-30 date: 2027-12-31 date: 2024-03-07 date: 2024-03-07 name: Sun Yat-sen University class: OTHER briefSummary: The goal of this open-label randomized controlled study is to assess the myeloprotective effect of trilaciclib in pan-cancer population. The main questions it aims to answer are:
* effect and safety of trilaciclib on myeloprotection in cancer patients receiving paclitaxel plus carboplatin chemotherapy
* does trilaciclib 's myeloprotective efficacy in patients receiving the same chemotherapy regimen correlate with tumor type
Participants will be randomized 2:1 to the treatment arm of trilaciclib in combination with a paclitaxel and carboplatin-based regimen and the control arm of a paclitaxel and carboplatin-based regimen for at least 6 cycles or until disease progression or intolerable toxicity. Patients in both groups could extend the chemotherapy cycle at the investigator 's discretion depending on the tumor type and in combination with anti-angiogenic/PD-X/anti-HER2 therapy. conditions: Non-Small Cell Lung Cancer conditions: Breast Cancer conditions: Endometrial Cancer conditions: Cervical Cancer conditions: Head And Neck Squamous Cell Carcinomas studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 132 type: ESTIMATED name: Trilaciclib Injection name: Paclitaxel name: Carboplatin measure: Occurrence of grade 3/4 neutropenia within 6 cycles sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Oncology,Sun Yat-sen University Cancer Center city: Guangzhou state: Guangdong zip: 510060 country: China lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06297798 id: SakaryaAppliedSciencesUPNS briefTitle: Effects of Telerehabilitation-Based Interventions on the Musculoskeletal System in Drivers overallStatus: NOT_YET_RECRUITING date: 2024-03-14 date: 2024-03-21 date: 2024-05-10 date: 2024-03-07 date: 2024-03-15 name: Sakarya Applied Sciences University class: OTHER briefSummary: This study is designed to examine the effect of telerehabilitation application on the musculoskeletal system of drivers.The study will include 40 voluntary participants who work as drivers on inter-district routes in Sakarya. The participants' sociodemographic information, musculoskeletal problems, and postures will be assessed. Participants will be divided into two groups: one group will receive tele-rehabilitation with posture and stabilization exercises, while the other group will serve as the control group. The exercises will be implemented for 10 weeks, followed by an 8-week tapering period, after which the groups will be crossed over. A re-evaluation will be conducted after 10 weeks, with follow-up assessments scheduled for 3 months later. conditions: Drive conditions: Musculoskeletal Diseases conditions: Postural; Defect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Telerehabilitation measure: MUSCLE SKELETAL SYSTEM ASSESSMENT measure: Posture Measures sex: MALE minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sakarya University of Applied Sciences city: Sakarya zip: 54000 country: Turkey name: Nurgul SEN, Master's degree role: CONTACT phone: 05344527440 email: pakizesen@subu.edu.tr name: Ceyhun TURKMEN, Assoc. Prof. role: PRINCIPAL_INVESTIGATOR hasResults: False
<\|newrecord\|> nctId: NCT06297785 id: 2022-03997-01 briefTitle: Online, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS) overallStatus: RECRUITING date: 2022-10-17 date: 2027-04 date: 2027-04 date: 2024-03-07 date: 2024-03-07 name: Sahlgrenska University Hospital, Sweden class: OTHER briefSummary: Adult IBS patients with symptoms refractory to standard medical treatment will receive online nurse-administered, gut-directed hypnotherapy in groups. The primary outcome measure was change in gastro-intestinal symptom severity. conditions: IBS - Irritable Bowel Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Gut-directed hypnotherapy measure: Change in gastrointestinal symptom severity sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mag-Tarmlab, Sahlgrenska University Hospital status: RECRUITING city: Gothenburg zip: 41345 country: Sweden name: Jenny Lövdahl role: CONTACT phone: 0313428107 email: magtarmlab.su@vgregion.se lat: 57.70716 lon: 11.96679 facility: Sahlgrenska University Hospital status: RECRUITING city: Gothenburg zip: 41345 country: Sweden lat: 57.70716 lon: 11.96679 hasResults: False
<\|newrecord\|> nctId: NCT06297772 id: RJBMT-003 briefTitle: Compare the Efficacy and Safety of Dec-FB4 and FB4 as Conditioning Regimen for AML-MR overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-01 date: 2028-05-01 date: 2024-03-07 date: 2024-03-13 name: Ruijin Hospital class: OTHER briefSummary: A multicenter, randomized, controlled clinical study comparing the efficacy and safety of allogeneic hematopoietic stem cell transplantation with decitabine-Fludarabine- busulfan (Dec-FB4) and Fludarabine-busulfan (FB4) as pretreatment regimens for the treatment of acute myeloid leukemia in adults with MR gene abnormalities conditions: AML, Adult studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 220 type: ESTIMATED name: Decitabine name: Fludarabine Injection name: Busulfan Injection measure: disease-free survival measure: incidence of relapse rate measure: Non-recurrent mortality sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ruijin Hospital city: Shanghai zip: 200025 country: China name: Xiaoxia Hu role: CONTACT phone: 862164370045 email: hxx12276@rjh.com.cn lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06297759 id: ATADEK-2023/16 briefTitle: The Validity and Reliability Study of Turkish Version of the Sense of Competence in Dementia Care Staff (SCIDS) Scale overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2024-07 date: 2024-09 date: 2024-03-07 date: 2024-03-07 name: Yeditepe University class: OTHER name: Acibadem University briefSummary: The purpose of the study is to adapt the SCIDS into the Turkish version and validate it in the social and cultural context of Turkey to assess staff competency in dementia care in the long-term care setting. conditions: Dementia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Questionnaire measure: Sense of Competence in Dementia Care Staff (SCIDS) Scale measure: Caring Behaviors Inventory-24 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06297746 id: am7mi3VB briefTitle: Subvastus vs. Medial Parapatellar Approaches in Total Knee Arthroplasty With Quadriceps Muscle Elastography overallStatus: COMPLETED date: 2023-07-10 date: 2023-12-01 date: 2023-12-01 date: 2024-03-07 date: 2024-03-08 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: ABSTRACT
INTRODUCTION
Knee osteoarthritis is a common joint pathology causing joint pain and ambulatory limitations. In primary total knee arthroplasty (TKA) surgeries, medial parapatellar (MP) and subvastus (SV) approaches are frequently used. The MP approach provides good exposure and is more widely used. In the SV approach, the vastus medialis muscle is preserved. Some argue that the extensor mechanism may heal earlier with the SV approach. In this study, unlike previous studies, the investigators aimed to quantitatively compare the early outcomes of MP and SV approaches, through shear wave elastography (SWE) measurements isolated over the vastus medialis and vastus lateralis muscles.
MATERIALS AND METHODS
The study included 20 patients with indications for TKA due to primary osteoarthritis, divided into MP and SV groups. SWE measurements of the vastus medialis and vastus lateralis muscles were performed preoperatively and at 3-month follow-up. Clinical scores (Knee Society Score and WOMAC) and straight leg raising time were recorded both preoperatively and postoperatively. conditions: Total Knee Arthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 20 type: ACTUAL name: Subvastus approach name: Medial Parapatellar approach measure: Shear wave values sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine city: Istanbul state: Fatih zip: 34098 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06297733 id: IstanbulBUFC3 briefTitle: Turkish Adaptation, Validity and Reliability of the Approaches and Study Skills Inventory in Physiotherapy Students overallStatus: RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-07-01 date: 2024-03-07 date: 2024-04-16 name: Istanbul Bilgi University class: OTHER briefSummary: The quality and quantity of learning are determined by the learning approach adopted by the student. When learning and studying approaches are mentioned, individual differences between learners' learning intentions during a learning situation or while studying and what types of strategies are used to achieve these intentions come to mind. These learning approaches are thought to determine the quality of learning outcomes. Many measurement tools have been developed to quantitatively measure learning and studying approaches. These developed tools are mostly applied at the higher education level. Among the purposes of using measurement tools; These include identifying low-performing students through screening, evaluating and identifying areas of difficulty that require prediction or improvement plans, evaluating before and after academic improvement programs, and raising awareness and advising students on their academic strengths and weaknesses.
When multidimensional measurement tools that evaluate students' study approaches and skills are examined, it is seen that the use of the Approaches and Study Skills Inventory for Students (ASSIST) tool has become widespread in recent years. This vehicle; It has been reported that it measures learning strategies and skills for different students and is sensitive enough to distinguish between learning types.
The Portuguese, Norwegian and Danish versions of the survey, which was developed in English and intended to be translated into Turkish as the Study Skills and Approaches Scale, have also been translated, its psychometric properties have been demonstrated and it has been observed that it is becoming widespread in the literature. conditions: Health Education studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 260 type: ESTIMATED name: Translating the Questionnaire into Turkish and Related Processes name: Validity name: Reliability measure: Approaches and Study Skills Inventory for Students measure: Participant Information Form sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Marmara University status: RECRUITING city: Istanbul zip: 34854 country: Turkey name: Ilksan Demirbuken, Prof role: CONTACT phone: 2167775701 phoneExt: +90 email: ilksan.demirbuken@marmara.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06297720 id: 2401110013 briefTitle: Early Oral Hydration After Thoracoscopic Surgery overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-02-28 date: 2025-06-30 date: 2024-03-07 date: 2024-03-07 name: Chang Gung Memorial Hospital class: OTHER briefSummary: The goal of this clinical trial is to learn about the safety and feasibility of early oral hydration in patients receiving video-assisted thoracoscopic surgery after general anesthesia. The main questions aims to answer:
* the safety and feasibility of oral hydration supplementation in the recovery room following general anesthesia.
* the degree of improvement in sore throat and dry mouth after oral hydration.
* the side effects and risks of oral hydration supplementation, such as the incidence of postoperative nausea and vomiting.
* the impact of oral hydration supplementation in the recovery room following general anesthesia on hemodynamics.
* patient satisfaction with oral hydration supplementation in the recovery room following general anesthesia.
Participants will receive a series of oral hydration from swab moistening, and ice cube hydration to water hydration in the recovery room. Researchers will compare with the standard, no-hydration group to see if it is safe and feasible to hydrate patients in the recovery room. conditions: Anesthesia conditions: Intubation Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Oral hydration measure: sore throat level by VAS (Visual Analogue Scale) measure: Mouth dryness measure: post-operative nausea and vomiting (PONV) measure: timing of post-operative nausea and vomiting (PONV) measure: duration of post-operative nausea and vomiting (PONV) measure: management of post-operative nausea and vomiting (PONV) measure: Heart Rate in PACU (Postanesthesia Care Unit) measure: Blood pressure in PACU (Postanesthesia Care Unit) measure: Patient's satisfaction sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ChangGung MH city: Taoyuan zip: 33380 country: Taiwan name: JUN-YU CHEN role: CONTACT lat: 24.95233 lon: 121.20193 hasResults: False
<\|newrecord\|> nctId: NCT06297707 id: P.T.REC/012/005044 briefTitle: Effect of Aquatic High Intensity Resistive Training on Patients With Chronic Heart Failure overallStatus: RECRUITING date: 2024-03-05 date: 2025-03-30 date: 2025-12-30 date: 2024-03-07 date: 2024-03-07 name: Cairo University class: OTHER briefSummary: PURPOSE:
to evaluate effect of aquatic high intensity resistive training on cardiac function and exercise capacity in patients with chronic heart failure.
BACKGROUND:
Heart failure (HF) is a rapidly growing public health issue with an estimated prevalence of \>37.7 million individuals globally. HF is a shared chronic phase of cardiac functional impairment secondary to many etiologies, and patients with HF experience numerous symptoms that affect their quality of life, including dyspnea, fatigue, poor exercise tolerance, and fluid retention. conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: aquatic high intensity resistive training name: usual care measure: Cardiac function measure: exercise capacity measure: physical symptoms of heart failure sex: ALL minimumAge: 45 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Physical Therapy status: RECRUITING city: Cairo state: Dokki zip: 11432 country: Egypt name: marwa M elsayed, phd role: CONTACT phone: 01156033818 phoneExt: 02 email: marwadd999@gmail.com name: marwa M elsayed, ph.d role: CONTACT phone: 01156033818 phoneExt: 02 email: marwadd999@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06297694 id: PamukkaleU. briefTitle: Clinical Interpretation and Cutoff Scores for ABILHAND Questionnaire in Rheumatoid Arthritis overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-07 date: 2024-03-07 date: 2024-03-07 name: Pamukkale University class: OTHER briefSummary: In individuals with rheumatoid arthritis, the most significant symptom is the loss of manual ability and function in the hands. In rheumatoid arthritis, where patient-reported assessment scales are frequently used, hand skills should be evaluated with an ideal questionnaire that best represents hand activities. The ABILHAND-RA questionnaire possesses all these features, being a short and easily fillable survey. The aim is to determine of clinically significant cutoff scores for perceived manual ability evaluated by ABILHAND corresponding to observed and perceived upper extremity assessments in individuals with rheumatoid arthritis. conditions: Rheumatoid Arthritis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 156 type: ESTIMATED measure: Disease Activity Score (DAS 28) measure: Nine hole peg test measure: Hand grip strength sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06297681 id: 2023-1-27-2 briefTitle: Combination of Daratumumab and BD Regimen and Dapagliflozin in the Treatment of M-protein Related Cardiac Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-01-30 date: 2025-12-31 date: 2024-03-07 date: 2024-03-07 name: Beijing Chao Yang Hospital class: OTHER name: Beijing Chuiyangliu Hospital name: Beijing Boren Hospital briefSummary: It is expected to include 40 patients with M-protein related cardiac disease. The treatment medication for enrolled patients must comply with the treatment regimen of Daratumumab + Bortezomib + Dexamethasone. All patients were given Dapagliflozin 10mg/day at the beginning of treatment (creatinine clearance rate greater than 20ml/min). conditions: M-protein Related Cardiac Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED name: Daratumumab + Bortezomib + Dexamethasone + Dapagliflozin measure: Objective response rate (ORR) measure: 2-year PFS rate, progression free survival (PFS) measure: 2-year OS rate, overall survival (OS) measure: Duration of Relief (DOR) measure: Next treatment time (TTNT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06297668 id: D5985C00008 briefTitle: A Study to Assess the Pharmacokinetics and Safety of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) Hydrofluoroolefin (HFO) With a Spacer (Treatment B), BGF MDI Hydrofluoroalkane (HFA) With a Spacer (Treatment A), as Well as BGF MDI HFO Without a Spacer (Treatment C). overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2024-06-13 date: 2024-06-13 date: 2024-03-07 date: 2024-03-07 name: AstraZeneca class: INDUSTRY briefSummary: This study aims to assess the effect on total systemic exposure and to characterize exposure BGF MDI HFO with a spacer compared to without a spacer; also, to demonstrate that total systemic exposure of BGF when administered as MDI HFO with a spacer is not greater than BGF MDI HFA with a spacer. conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: Treatment A: BGF MDI HFA name: Treatment B: BGF MDI HFO name: Treatment C: BGF MDI HFO name: AeroChamber Plus Flow-Vu spacer measure: Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast) of BGF MDI measure: Maximum Observed Concentration (Cmax) of BGF MDI measure: Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast) measure: Maximum Observed Concentration (Cmax) measure: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) measure: Time to Reach Maximum Observed Concentration (tmax) measure: Terminal Rate Constant (λz) measure: Half-life Associated with Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t1/2λz) measure: Mean Residence Time of the Unchanged Drug in the Systemic Circulation from Zero to Infinity (MRTinf) measure: Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F) measure: Apparent Volume of Distribution at Steady State Following Extravascular Administration (Vz/F) measure: Number of Participants with Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Research Site city: Berlin zip: 14050 country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site city: Harrow zip: HA1 3UJ country: United Kingdom lat: 51.57142 lon: -0.33371 hasResults: False
<\|newrecord\|> nctId: NCT06297655 id: TQG202-III-01 briefTitle: A Clinical Study of Recombinant Human Coagulation Factor VIII for Injection in Patients With Severe Hemophilia A overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-03-07 date: 2024-03-07 name: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: This study is a single arm, open, multicenter clinical trial in which the previous treated severe hemophilia A patients receive recombinant human coagulation factor VIII for injection to evaluate the efficacy and safety of on-demand treatment in the event of new bleeding events. If evaluable surgical cases occur, the overall efficacy and safety of recombinant human coagulation factor VIII for injection as a replacement therapy for severe hemophilia A PTPs during the perioperative period will be evaluated. conditions: Hemophilia A studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Recombinant human activated coagulation factor VIII for injection measure: The proportion of on-demand treatment improvement for newly occurring bleeding events measure: Activity recovery measure: The proportion of effective surgical hemostasis measure: Annualized bleeding rate (ABR) measure: The incidence of Less Han Expected Thermal Effect measure: The injection times of recombinant human coagulation factor VIII measure: The dosage of recombinant human coagulation factor VIII measure: Changes of Haemophilia Joint Health Score before and after on-demand treatment measure: Changes of Quality of Life Assessment before and after on-demand treatment sex: ALL minimumAge: 12 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Provincial Hospital city: Hefei state: Anhui zip: 230002 country: China name: Juan Tong, Doctor role: CONTACT phone: 13955114442 email: tongj5200@163.com lat: 31.86389 lon: 117.28083 facility: The Second Affiliated Hospital of Chongqing Medical University city: Chongqing state: Chongqing zip: 400010 country: China name: Shu Chen, Master role: CONTACT phone: 13983420188 email: chenshu921@163.com lat: 29.56278 lon: 106.55278 facility: The First Hospital of Lanzhou University city: Lanzhou state: Gansu zip: 730013 country: China name: Yaming Xi, Doctor role: CONTACT phone: 13919110815 email: xiyaming02@163.com lat: 36.05701 lon: 103.83987 facility: Nanfang Hospital, Southern Medical University city: Guangzhou state: Guangdong zip: 510515 country: China name: Jing Sun, Doctor role: CONTACT phone: 13316202696 email: jsun-cn@qq.com lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Guangxi Medical University city: Nanning state: Guangxi zip: 530021 country: China name: Peng Cheng, Master role: CONTACT phone: 13977166448 email: 13977166448@163.com lat: 22.81667 lon: 108.31667 facility: Henan Tumor Hospital city: Zhengzhou state: Henan zip: 450003 country: China name: Hu Zhou, Doctor role: CONTACT phone: 13939068863 email: papertigerhu@163.com lat: 34.75778 lon: 113.64861 facility: Xiangya Hospital Central South University city: Changsha state: Hunan zip: 410008 country: China name: Jie Peng, Doctor role: CONTACT phone: 13974802938 email: pengjie-0728@163.com lat: 28.19874 lon: 112.97087 facility: Nanjing Drug Tower Hospital city: Nanjing state: Jiangsu zip: 210008 country: China name: Rongfu Zhou, Doctor role: CONTACT phone: 13605142342 email: rfzhoucn@163.com lat: 32.06167 lon: 118.77778 facility: Jiangxi Provincial People's Hospital city: Nanchang state: Jiangxi zip: 330006 country: China name: Chenghao Jin, Doctor role: CONTACT phone: 13699500207 email: Jinch227@aliyun.com lat: 28.68396 lon: 115.85306 facility: Hematology Hospital of Chinese Academy of Medical Sciences city: Tianjin state: Tianjin zip: 300020 country: China name: Lei Zhang, Doctor role: CONTACT phone: 13502118379 email: zhanglei1@ihcams.ac.cn lat: 39.14222 lon: 117.17667 facility: The Second Affiliated Hospital of Kunming Medical University city: Kunming state: Yunnan zip: 650106 country: China name: Zeping Zhou, Doctor role: CONTACT phone: 18788571605 email: 18788571605@163.com lat: 25.03889 lon: 102.71833 hasResults: False
<\|newrecord\|> nctId: NCT06297642 id: TQB2928-AK105-Ib-01 briefTitle: TQB2928 Injection Combined With Penpulimab in Treatment of Advanced Malignant Tumors. overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-06 date: 2028-03 date: 2024-03-07 date: 2024-03-19 name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: This study will evaluate the safety and efficiency of TQB2928 injection combined with Penpulimab in the treatment of patients with advanced malignant tumors. conditions: Advanced Malignant Neoplasm studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 114 type: ESTIMATED name: TQB2928 injection name: Penpulimab measure: Dose limiting toxicity (DLT) measure: Adverse event rate measure: Objective response rate (ORR) measure: Complete response rate (CRR) measure: Disease Control Rate measure: Duration of Response measure: Progression-free Survival measure: Overall survival (OS) measure: Incidence of Anti-Drug antibody measure: Incidence of neutralizing antibodies measure: Peak time (Tmax) measure: Peak concentration (Cmax) measure: The area under the plasma concentration time curve from zero to after 24h (AUC0-24h) measure: Steady-state apparent volume of distribution (Vz/F) measure: Minimum plasma concentration at steady state (Cmin,ss) measure: Receptor Occupancy (RO%) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital Chinese Academy of Medical Science city: Beijing state: Beijing zip: 100021 country: China name: Ning Li, Doctor role: CONTACT phone: 15601395554 email: lining@cicams.ac.cn lat: 39.9075 lon: 116.39723 facility: Gansu Provincial Cancer Hospital city: Lanzhou state: Gansu zip: 730000 country: China name: Junfeng Jiang, Master role: CONTACT phone: 13893332604 email: 13893332604@163.com name: Yuhua Liu, Bachelor role: CONTACT phone: 15682892029 email: tianlujyx@163.com lat: 36.05701 lon: 103.83987 facility: Sun Yat-sen University Cancer Center city: Guangzhou state: Guangdong zip: 510000 country: China name: Qingqing Cai, Doctor role: CONTACT phone: 18376665396 email: caiqq@sysucc.org.cn lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06297629 id: 2021-0636 id: NCI-2024-01689 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: A Phase I/II Trial to Assess the Efficacy and Toxicity of ASTX727 (Oral Decitabine/Cedazuridine) for the Treatment of Hematological Neoplasms After Allogeneic Stem Cell Transplantation overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2024-08-31 date: 2026-08-31 date: 2024-03-07 date: 2024-04-11 name: M.D. Anderson Cancer Center class: OTHER name: Astex Pharmaceuticals, Inc. briefSummary: To learn if ASTX727 given alone or in combination with donor lymphocyte infusion (DLI) can help to control certain types of hematological neoplasms (blood-based cancers) after a stem cell transplant. conditions: Allogeneic Stem Cell Transplantation studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 65 type: ESTIMATED name: ASTX727 name: Donor Lymphocyte Infusion measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Betul Oran, MD role: CONTACT phone: 713-745-2820 email: boran@mdanderson.org name: Betul Oran, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
<\|newrecord\|> nctId: NCT06297616 id: 18814 id: J3R-JE-YDAB type: OTHER domain: Eli Lilly and Company briefTitle: A Study of LY3841136 in Japanese Participants With Obesity or Overweight overallStatus: RECRUITING date: 2024-04-15 date: 2025-10-12 date: 2025-10-12 date: 2024-03-07 date: 2024-04-19 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to learn about the side effects of LY3841136 when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last about 28 weeks and may include up to 17 visits. conditions: Obesity conditions: Overweight studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: LY3841136 name: Placebo measure: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136 measure: PK: Maximum Observed Concentration (Cmax) of LY3841136 measure: Pharmacodynamics (PD): Change From Baseline in Body Weight sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sumida Hospital status: RECRUITING city: Sumida-ku state: Tokyo zip: 130-0004 country: Japan role: CONTACT phone: 81356087276 name: Takuma Yonemura role: PRINCIPAL_INVESTIGATOR facility: Hakata Clinic status: RECRUITING city: Fukuoka zip: 812-0025 country: Japan role: CONTACT phone: 81922837701 name: Takashi Eto role: PRINCIPAL_INVESTIGATOR lat: 33.6 lon: 130.41667 hasResults: False
<\|newrecord\|> nctId: NCT06297603 id: 18806 id: J1I-MC-GZQA type: OTHER domain: Eli Lilly and Company briefTitle: Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3) overallStatus: RECRUITING date: 2024-03-15 date: 2026-09-11 date: 2026-10-09 date: 2024-03-07 date: 2024-04-11 name: Eli Lilly and Company class: INDUSTRY briefSummary: The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 320 type: ESTIMATED name: Retatrutide name: Placebo measure: Change from Baseline in Hemoglobin A1c (HbA1c) (%) measure: Percentage of Participants Achieving HbA1c <7.0% measure: Percentage of Participants Achieving HbA1c ≤6.5% measure: Change from Baseline in Fasting Serum Glucose measure: Percentage of Time Continuous Glucose Monitoring (CGM) Glucose Values are Between 70 and 180 mg/dL measure: Percent Change from Baseline in Body Weight measure: Change from Baseline in Body Weight measure: Percentage of Participants Achieving Weight Reduction of ≥5% measure: Percentage of Participants Achieving Weight Reduction of ≥10% measure: Percentage of Participants Achieving Weight Reduction of ≥15% measure: Percentage of Participants Achieving HbA1c ≤6.5% and ≥10% Weight Reduction measure: Percent Change from Baseline in Non-HDL Cholesterol measure: Percent Change from Baseline in Triglycerides measure: Change from Baseline in Systolic Blood Pressure (SBP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Institute of Arizona (CRI) - Sun City West status: RECRUITING city: Sun City West state: Arizona zip: 85375 country: United States name: Jalal Abbas role: PRINCIPAL_INVESTIGATOR lat: 33.66198 lon: -112.34127 facility: Diabetes and Endocrine Associates status: NOT_YET_RECRUITING city: La Mesa state: California zip: 91942 country: United States name: Robert Lipetz role: PRINCIPAL_INVESTIGATOR lat: 32.76783 lon: -117.02308 facility: UCLA South Bay Endocrinology status: RECRUITING city: Torrance state: California zip: 90505 country: United States name: Dianne Cheung role: PRINCIPAL_INVESTIGATOR lat: 33.83585 lon: -118.34063 facility: Northeast Research Institute (NERI) status: NOT_YET_RECRUITING city: Fleming Island state: Florida zip: 32003 country: United States name: Senan Sultan role: PRINCIPAL_INVESTIGATOR lat: 30.0933 lon: -81.71898 facility: Care Research status: NOT_YET_RECRUITING city: Idaho Falls state: Idaho zip: 83404 country: United States name: Hira Siktel role: PRINCIPAL_INVESTIGATOR lat: 43.46658 lon: -112.03414 facility: Cotton O'Neil Clinical Research Center status: RECRUITING city: Topeka state: Kansas zip: 66606 country: United States name: Alan Wynne role: PRINCIPAL_INVESTIGATOR lat: 39.04833 lon: -95.67804 facility: Billings Clinic status: NOT_YET_RECRUITING city: Billings state: Montana zip: 59101 country: United States name: Lauren Kleess role: PRINCIPAL_INVESTIGATOR lat: 45.78329 lon: -108.50069 facility: Sierra Nevada Specialty Care status: NOT_YET_RECRUITING city: Reno state: Nevada zip: 89511 country: United States name: David Howard role: PRINCIPAL_INVESTIGATOR lat: 39.52963 lon: -119.8138 facility: Albany Medical College, Division of Community Endocrinology status: NOT_YET_RECRUITING city: Albany state: New York zip: 12203 country: United States name: Robert Busch role: PRINCIPAL_INVESTIGATOR lat: 42.65258 lon: -73.75623 facility: Research Foundation of SUNY - University of Buffalo status: NOT_YET_RECRUITING city: Buffalo state: New York zip: 14221 country: United States name: Ajay Chaudhuri role: PRINCIPAL_INVESTIGATOR lat: 42.88645 lon: -78.87837 facility: NYC Research INC status: RECRUITING city: Long Island City state: New York zip: 11106 country: United States name: Anastasios Manessis role: PRINCIPAL_INVESTIGATOR lat: 40.74482 lon: -73.94875 facility: University of North Carolina Medical Center status: NOT_YET_RECRUITING city: Chapel Hill state: North Carolina zip: 27514 country: United States name: Klara Klein role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 facility: Lucas Research, Inc. status: NOT_YET_RECRUITING city: Hickory state: North Carolina zip: 28601 country: United States name: Anthony Barber role: PRINCIPAL_INVESTIGATOR lat: 35.73319 lon: -81.3412 facility: Cleveland Clinic status: NOT_YET_RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States name: Willy Marcos Valencia role: PRINCIPAL_INVESTIGATOR lat: 41.4995 lon: -81.69541 facility: Central States Research status: RECRUITING city: Tulsa state: Oklahoma zip: 74136 country: United States name: Sarah Land role: PRINCIPAL_INVESTIGATOR lat: 36.15398 lon: -95.99277 facility: Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair status: NOT_YET_RECRUITING city: Pittsburgh state: Pennsylvania zip: 15243 country: United States name: Daniel Austin role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 facility: AM Diabetes & Endocrinology Center status: NOT_YET_RECRUITING city: Bartlett state: Tennessee zip: 38133 country: United States name: Kashif Latif role: PRINCIPAL_INVESTIGATOR lat: 35.20453 lon: -89.87398 facility: Dallas Diabetes Research Center status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States name: Dan Lender role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: Juno Research status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77040 country: United States name: Damaris Vega role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 facility: Endocrine Ips, Pllc status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77079 country: United States name: Prashant Koshy role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 facility: Southern Endocrinology Associates status: NOT_YET_RECRUITING city: Mesquite state: Texas zip: 75149 country: United States name: Sumana Gangi role: PRINCIPAL_INVESTIGATOR lat: 32.7668 lon: -96.59916 facility: Diabetes & Endocrine Treatment Specialists status: NOT_YET_RECRUITING city: Sandy state: Utah zip: 84093 country: United States name: Timothy Graham role: PRINCIPAL_INVESTIGATOR lat: 40.59161 lon: -111.8841 facility: CEDIC status: NOT_YET_RECRUITING city: Caba state: Buenos Aires zip: C1060ABN country: Argentina name: Elizabeth Gelersztein role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Centro de Investigaciones Metabólicas (CINME) status: NOT_YET_RECRUITING city: Ciudad Autónoma de Buenos Aires state: Buenos Aires zip: 1056 country: Argentina name: Federico Perez Manghi role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: CIMeL Clinical Research status: NOT_YET_RECRUITING city: Lanus state: Buenos Aires zip: B1824KAJ country: Argentina name: Mariano Chahin role: PRINCIPAL_INVESTIGATOR lat: -34.70252 lon: -58.3955 facility: Centro de Investigaciones Médicas Mar del Plata status: NOT_YET_RECRUITING city: Mar del Plata state: Buenos Aires zip: 7600 country: Argentina name: Andres Alvarisqueta role: PRINCIPAL_INVESTIGATOR lat: -38.00228 lon: -57.55754 facility: DIM Clínica Privada status: NOT_YET_RECRUITING city: Ramos Mejía state: Buenos Aires zip: B1704ETD country: Argentina name: Alejandra Camino role: PRINCIPAL_INVESTIGATOR lat: -34.6551 lon: -58.55318 facility: Investigaciones Medicas Imoba Srl status: NOT_YET_RECRUITING city: Buenos Aires state: Ciudad Autónoma De Buenos Aires zip: C1056ABH country: Argentina name: Silvia Orio role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Centro Médico Viamonte status: NOT_YET_RECRUITING city: Buenos Aires state: Ciudad Autónoma De Buenos Aires zip: C1120AAC country: Argentina name: Diego Aizenberg role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Instituto de Investigaciones Clinicas Zarate status: NOT_YET_RECRUITING city: Rosario state: Santa Fe zip: 2000 country: Argentina name: Marisa Vico role: PRINCIPAL_INVESTIGATOR lat: -32.94682 lon: -60.63932 facility: Instituto de Investigaciones Clinicas Rosario status: NOT_YET_RECRUITING city: Rosario state: Santa Fe zip: S2000CVD country: Argentina name: Maximiliano Sicer role: PRINCIPAL_INVESTIGATOR lat: -32.94682 lon: -60.63932 facility: Centro Médico Colón status: NOT_YET_RECRUITING city: Córdoba zip: 5003 country: Argentina name: Maria Parody role: PRINCIPAL_INVESTIGATOR lat: -31.4135 lon: -64.18105 facility: Centro de Endocrinologia Alcantara Gonzalez status: NOT_YET_RECRUITING city: Bayamon zip: 00959 country: Puerto Rico name: Altagracia Alcantara -Gonzalez role: PRINCIPAL_INVESTIGATOR lat: 18.39856 lon: -66.15572 facility: Private Practice - Dr. Paola Mansilla-Letelier status: NOT_YET_RECRUITING city: Guaynabo zip: 00970 country: Puerto Rico name: Paola Mansilla-Letelier role: PRINCIPAL_INVESTIGATOR lat: 18.35745 lon: -66.111 facility: Endocrinologist Metabolic Clinic & Research Institute status: NOT_YET_RECRUITING city: San Juan zip: 00921 country: Puerto Rico name: Martha Gomez-Cuellar role: PRINCIPAL_INVESTIGATOR lat: 18.46633 lon: -66.10572 facility: Panthera Biopartners - Preston status: NOT_YET_RECRUITING city: Preston state: England zip: PR2 9QB country: United Kingdom name: Reem Handforth role: PRINCIPAL_INVESTIGATOR lat: 53.76282 lon: -2.70452 facility: Lister Hospital status: NOT_YET_RECRUITING city: Stevenage state: Hertfordshire zip: SG1 4AB country: United Kingdom name: Adie Viljoen role: PRINCIPAL_INVESTIGATOR lat: 51.90224 lon: -0.20256 facility: Panthera Biopartners - Manchester status: NOT_YET_RECRUITING city: Rochdale state: Manchester zip: OL11 4AU country: United Kingdom name: Krishnakumar Radhakrishnan role: PRINCIPAL_INVESTIGATOR lat: 53.61766 lon: -2.1552 facility: Panthera Biopartners - Glasgow status: NOT_YET_RECRUITING city: Glasgow state: Scotland zip: G51 4LB country: United Kingdom name: Raghavendra Madimchetty role: PRINCIPAL_INVESTIGATOR lat: 55.86515 lon: -4.25763 hasResults: False
<\|newrecord\|> nctId: NCT06297590 id: 18795 id: J4T-MC-OLAA type: OTHER domain: Eli Lilly and Company id: 2024-510604-37-00 type: OTHER domain: EU Trial Number id: U1111-1302-6222 type: OTHER domain: Universal Trial Number briefTitle: A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-02 date: 2027-02 date: 2024-03-07 date: 2024-04-17 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to evaluate the safety of LY3954068 in participants with early symptomatic Alzheimer's Disease (AD). The study will also investigate how much LY3954068 gets into the bloodstream and will test the effects of LY3954068 on markers of AD.
The study will be comprised of two parts, A and B. Part B is optional, and participants from Part A may also have the opportunity to join an optional bridging period to a separate potential study where participants would receive LY3954068. Each enrolled participant in Part A will receive a single dose of LY3954068 or placebo (no active drug) given into the spinal fluid. If conducted, each participant in Part B would receive 2 doses of either LY3954068 or placebo administered into the spinal fluid.
The study will last up to approximately 69 weeks for Part A, and, if conducted, 73 weeks for Part B. If conducted, the optional bridging period for Part A participants would last up to approximately 1 year after their completion of Part A.
If the optional bridging period is conducted, participants in Part A could be enrolled in the separate potential study for up to approximately 120 weeks. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: LY3954068 name: Placebo name: Flortaucipir F18 measure: Part A: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration measure: Part B: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration measure: Part A: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) measure: Optional Part B: PK: Cmax measure: Part A: PK: Area Under the Concentration Versus Time Curve (AUC) measure: Optional Part B: PK: AUC measure: Part A: PK: Cerebrospinal Fluid (CSF) concentration of LY3954068 measure: Optional Part B: PK: CSF concentration of LY3954068 measure: Part A: Pharmacodynamics (PD): Change from Baseline of CSF tau measure: Optional Part B: PD: Change from Baseline of CSF tau sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: K2 Medical Research LLC city: Maitland state: Florida zip: 32751 country: United States role: CONTACT phone: 407-500-5252 name: Brandon Lenox role: PRINCIPAL_INVESTIGATOR lat: 28.62778 lon: -81.36312 facility: Charter Research, LLC city: The Villages state: Florida zip: 32162 country: United States role: CONTACT phone: 352-775-1000 name: Jeffrey Norton role: PRINCIPAL_INVESTIGATOR lat: 28.93408 lon: -81.95994 facility: Indiana University School of Medicine - Clinical Research Center city: Indianapolis state: Indiana zip: 46202 country: United States role: CONTACT phone: 317-963-7505 name: Jared Brosch role: PRINCIPAL_INVESTIGATOR lat: 39.76838 lon: -86.15804 facility: Massachusetts General Hospital (MGH) city: Charlestown state: Massachusetts zip: 02129 country: United States role: CONTACT phone: 617-643-5607 name: Steven Arnold role: PRINCIPAL_INVESTIGATOR lat: 42.37787 lon: -71.062 facility: CenExel AMRI city: Toms River state: New Jersey zip: 08755 country: United States role: CONTACT phone: 732-341-9500 name: Sanjiv Sharma role: PRINCIPAL_INVESTIGATOR lat: 39.95373 lon: -74.19792 facility: Duke University city: Durham state: North Carolina zip: 27710 country: United States name: Shruti Raja role: PRINCIPAL_INVESTIGATOR lat: 35.99403 lon: -78.89862 facility: Medical College of Wisconsin city: Milwaukee state: Wisconsin zip: 53226 country: United States role: CONTACT phone: 414-955-0650 name: Malgorzata Franczak role: PRINCIPAL_INVESTIGATOR lat: 43.0389 lon: -87.90647 facility: The University of Tokyo Hospital city: Bunkyo-ku state: Tokyo zip: 113-8655 country: Japan role: CONTACT phone: +81-33-815-5411 name: Takeshi Iwatsubo role: PRINCIPAL_INVESTIGATOR lat: 35.37517 lon: 139.92991 facility: National Hospital for Neurology and Neurosurgery (UCLH) city: London zip: WC1N 3BG country: United Kingdom role: CONTACT phone: 0203 448 3011 name: Catherine Mummery role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Royal Hallamshire Hospital city: Sheffield zip: S10 2JF country: United Kingdom name: Daniel Blackburn role: PRINCIPAL_INVESTIGATOR lat: 53.38297 lon: -1.4659 facility: University Hospital Southampton city: Southampton zip: SO16 6YD country: United Kingdom name: Christopher Kipps role: PRINCIPAL_INVESTIGATOR lat: 50.90395 lon: -1.40428 hasResults: False
<\|newrecord\|> nctId: NCT06297577 id: MASH2024 briefTitle: Clinical Evaluation of Injectable Alb-PRF in the Management of Intrabony Defect in Stage-III Periodontitis Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-06-15 date: 2025-09-30 date: 2024-03-07 date: 2024-03-18 name: Cairo University class: OTHER briefSummary: Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients.
The goal of this clinical trial is to compare Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. The main question aims to answer are:
will Albumin Platelet Rich Fibrin (Alb-PRF) as adjunct to minimally invasive surgical technique (MIST) be superior in terms of improvement in clinical parameters compared to the use of PRF with MIST. conditions: Intrabony Periodontal Defect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Due to the type of intervention, only the outcome assessor and the statistician will be blinded whoMasked: OUTCOMES_ASSESSOR count: 26 type: ESTIMATED name: Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST) name: Platelet Rich Fibrin (PRF) combined with minimally invasive surgical technique (MIST) measure: Clinical attachment level (CAL) measure: Probing Depth (PD) measure: Radiographic Linear Defect Depth (RLDD) measure: Recession Depth (RD) measure: Post-operative Pain measure: Radiographic defect fill (RDF) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06297564 id: 07/3/9-2023/4 briefTitle: Progesterone Primed Endometrial Protocol Versus Gonadotropin-releasing Hormone Antagonist Protocol in Assisted Reproductive Treatments overallStatus: COMPLETED date: 2022-09-01 date: 2024-01-01 date: 2024-01-01 date: 2024-03-07 date: 2024-03-07 name: New Valley University class: OTHER briefSummary: The aim of this study was to compare the clinical outcomes in progesterone primed endometrial protocol versus gonadotropin-releasing hormone antagonist protocol in women undergoing assisted reproductive treatments. conditions: Progesterone Primed Endometrial Protocol conditions: Gonadotropin Releasing Hormone Antagonist Protocol conditions: Assisted Reproductive Treatments studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ACTUAL name: Progesterone primed endometrial protocol name: Gonadotropin-releasing hormone antagonist protocol measure: The number of retrieved oocytes measure: Pregnancy rate sex: FEMALE minimumAge: 21 Years maximumAge: 40 Years stdAges: ADULT facility: New Valley University city: New Valley zip: 72511 country: Egypt hasResults: False
<\|newrecord\|> nctId: NCT06297551 id: SBU-AML-LSC id: IRB2023-00528 type: OTHER domain: Stony Brook University briefTitle: Acute Myeloid Leukemia and Markers of Leukemia Stem Cells (CLL1 and CD45RA) overallStatus: RECRUITING date: 2024-03-05 date: 2025-05-31 date: 2025-05-31 date: 2024-03-07 date: 2024-03-07 name: Suhu Liu class: OTHER briefSummary: Acute myeloid leukemia (AML) is a malignant disorder of the bone marrow and the most common form of acute leukemia in adults. Patient with AML have the shortest survival compared to other forms of leukemia. In the past 6 years, several new therapies have been approved. Biomarkers are in urgent need to guide therapeutic regimen selection in order to maximize the benefit of available therapies and minimize treatment toxicity. Current standard practice is to perform bone marrow biopsy at end of treatment cycle (each cycle around 28 days), and based on bone marrow finding, to decide further treatment plan. It is invasive and time consuming. The research we are proposing here is to investigate whether tracking leukemia stem cells (LSC) in peripheral blood during early treatment cycle may provide a non-invasive method to predict therapeutic outcome at end of treatment cycle. Our retrospective study have found that LSC fractional change, defined by two LSC markers, named CLL1 and CD45RA, is highly correlated with therapeutic outcome. Further more, CLL1 and CD45RA positive LSC fraction demonstrates a high concordance between bone marrow and peripheral blood, offering the opportunity to track CLL1 and CD45RA positive LSC fraction non-invasively in peripheral blood during treatment. This pilot study will allow us to decide whether testing CLL1 and CD45RA positive LSC in peripheral blood during leukemia treatment is feasible in clinical practice. This result will lay the foundation for designing future trials using CLL1 and CD45RA positive LSC fractional change to optimize therapeutic strategy for patients with AML. conditions: Acute Myeloid Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Quantification of blood cells positive for CLL1 and CD45RA surface markers by flow cytometry measure: Concordance between the relative fraction of Leukemia Stem Cells (LSC) vs Hematopoietic Stem Cells (HSC) and treatment response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stony Brook Cancer Center status: RECRUITING city: Stony Brook state: New York zip: 11794 country: United States name: Caterina Vacchi-Suzzi, PhD role: CONTACT phone: 631-728-7425 email: cancerclinicaltrials@stonybrookmedicine.edu name: Suhu Liu, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 40.92565 lon: -73.14094 hasResults: False
<\|newrecord\|> nctId: NCT06297538 id: GR-2021-12372323 briefTitle: Parkinson's Disease and Gamma-transcranial Alternating Current Stimulation overallStatus: RECRUITING date: 2023-04-29 date: 2024-10-29 date: 2026-04-29 date: 2024-03-07 date: 2024-03-07 name: Neuromed IRCCS class: OTHER name: Fondazione Policlinico Universitario Campus Bio-Medico name: I.R.C.C.S. Fondazione Santa Lucia briefSummary: Cortical-basal ganglia gamma oscillations are pathologically reduced in Parkinson's disease (PD) and the plasticity of the primary motor cortex (M1) is impaired. Enhancing gamma oscillations through transcranial alternating current stimulation (tACS), a non-invasive neurophysiological tool that modulates cortical rhythms, can restore this alteration. However, whether tACS-related normalization of M1 plasticity results in positive clinical effects is unknown. Motor learning is also impaired in PD and gamma oscillations play a relevant role in different forms of learning in humans. Nevertheless, whether motor learning abnormalities relate to reduced gamma oscillations in PD is another unclear issue. It can be hypothesized that gamma oscillations impairment in M1 contributes to altered motor control, plasticity and learning in PD. Accordingly, in this project, the authors intend to test whether gamma-tACS on M1 in PD patients ameliorates motor performance and learning, as objectively assessed with kinematic techniques. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: gamma transcranial alternating current stimulation (tACS) name: sham transcranial alternating current stimulation (tACS) measure: Changes in bradykinesia features as objectively assessed by kinematic techniques measure: Changes in motor learning performance as objectively assessed by kinematic techniques sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Neuromed status: RECRUITING city: Pozzilli country: Italy name: Giulia Paparella role: CONTACT phone: 3384780752 lat: 41.51142 lon: 14.06252 hasResults: False
<\|newrecord\|> nctId: NCT06297525 id: STP938-201 briefTitle: Study of STP938 in Advanced Solid Tumours overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-12 date: 2027-05 date: 2024-03-07 date: 2024-03-08 name: Step Pharma, SAS class: INDUSTRY briefSummary: The Phase 1a part of the study is a dose escalation of STP938 as a monotherapy.
The Phase 1b part of the study is a safety expansion cohort of STP938 as a monotherapy. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Patients will be assigned to a dose level of STP938 (Phase 1a) or an expansion cohort (Phase 1b) at the time of their enrollment. primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: STP938 measure: Safety and Tolerability measure: Area under the curve (AUC) of STP938 measure: Maximum plasma concentration (Cmax) measure: Time to reach maximum concentration (TMax) measure: Evaluation of preliminary clinical activity of STP938 measure: Evaluation of best overall response of STP938 measure: Evaluation of Duration of Response measure: Evaluation of Progression Free Survival measure: Change in serum CA125 (ovarian cancer only) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06297512 id: pGBM-WBRT/DOX2020 briefTitle: Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM). overallStatus: RECRUITING date: 2022-12-09 date: 2027-11-09 date: 2028-03-09 date: 2024-03-07 date: 2024-03-07 name: Iacopo Sardi class: OTHER briefSummary: Glioblastoma (GBM) and diffuse intrinsic bridge gliomas (DIPG) only the most aggressive forms of cancer, and their prognosis remains bleak. Currently, the standard of treatment is TMZ concomitant with radiotherapy, and, at the end of combined treatment, as adjuvant therapy. In vitro and in vivo experimental studies have suggested that anthracyclines are effective antineoplastics for the treatment of gliomas. In patients with solid tumors treated with anthracyclines, continuous infusion administration compared with bolus administration has been shown to provide a better safety profile especially with regard to cardiotoxicity. Based on this evidence, this study aims to evaluate the safety and antitumor activity of combined treatment with Dox, WBRT (whole body radiotherapy), and TMZ in pediatric and young adult patients affected by GMB conditions: Glioblastoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Radiotherapy, Temozolomide, Doxorubicin measure: Evaluation prolonged Dox measure: Percentage of Withdrawal from the study rate measure: Percentage of SAEs measure: Mortality rate measure: Early discontinuation of dox treatment rate measure: Event-free survival (EFS), disease progression (PFS), and overall survival (OS) sex: ALL minimumAge: 3 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence country: Italy name: Iacopo Sardi role: CONTACT email: iacopo.sardi@meyer.it lat: 43.77925 lon: 11.24626 hasResults: False
<\|newrecord\|> nctId: NCT06297499 id: IRB-22-07-4803 briefTitle: Ondansetron Use for Preventing Pruritus In Patients Undergoing Cesarean Section overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-08-01 date: 2024-12-01 date: 2024-03-07 date: 2024-03-12 name: Wayne State University class: OTHER briefSummary: Opioids are often added with a local anesthetic to enhance the duration and quality of spinal anesthesia for cesarean delivery patients. However, spinal opioids are associated with a wide variety of side effects such as nausea, vomiting, (N/V) and pruritus (itching). The occurrence of pruritus can vary between 30% and 100% making pruritus the most common side-effect of intrathecal opioids and this rate is even higher in pregnant patients. Pruritus may require treatment which can be ineffective or sometimes reverse the analgesic effect of the opioids. Ondansetron is a safe and very commonly used Serotonin receptor antagonist treatment for local anesthetic opioid-induced pruritus used in pregnancy. The effect of different administration times of ondansetron in reducing pruritus or N/V in cesarean section (CS) cases has not been extensively studied and thus, this prospective study can help guide future clinical management of side effects caused by spinal intrathecal morphine administration. conditions: Pruritus Caused by Drug studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized double-blinded trial primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The patient will be unaware of their grouping allotment. The outcomes assessor will be unaware of the patient grouping allotment. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 66 type: ESTIMATED name: Ondansetron 8mg measure: Pruritus parameters in Post anesthesia Care Unit (PACU) measure: Pruritus severity in Post anesthesia Care Unit (PACU) measure: Pruritus parameters PACU measure: Pruritus severity PACU measure: Rescue Pruritus Treatment medication measure: Nausea PACU measure: Nausea Post PACU measure: Post-operative Pain measure: Peripheral oxygen saturation- Mother measure: Peripheral oxygen saturation- Infant measure: Heart rate- Mother measure: Heart rate- Infant measure: Blood pressure Mother measure: Blood pressure- Infant measure: Electrocardiogram (ECG ) Mother measure: ECG Infant sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Detroit Medical Center- Hutzel Women's Hospital city: Detroit state: Michigan zip: 48201 country: United States name: George M McKelvey, PhD role: CONTACT phone: 313-598-6036 email: gmckelve@dmc.org name: Justin Hruska, MD role: CONTACT phone: 402-432-0985 email: justinhruska1@gmail.com lat: 42.33143 lon: -83.04575 hasResults: False
<\|newrecord\|> nctId: NCT06297486 id: SPK-8011-302 id: 2023-504537-46 type: EUDRACT_NUMBER briefTitle: Study of a Gene Therapy Treatment for Hemophilia A acronym: KEYSTONE 1 overallStatus: RECRUITING date: 2024-03-13 date: 2027-05 date: 2035-09-04 date: 2024-03-07 date: 2024-04-18 name: Spark Therapeutics, Inc. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy of SPK-8011 in preventing bleed episodes compared with FVIII prophylaxis in participants with hemophilia A without FVIII inhibitors on routine FVIII prophylaxis. conditions: Hemophilia A studyType: INTERVENTIONAL phases: PHASE3 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be assigned into one of three cohorts, each receiving the same study treatment. primaryPurpose: TREATMENT masking: NONE count: 85 type: ESTIMATED name: SPK-8011 measure: Annualized Bleed Rate (ABR) for All Bleeds [Cohort A] measure: Median FVIII: C levels [Cohort A] measure: ABR for treated bleeds [Cohort A] measure: Percentage of Participants with ABR=0 for all bleeds; treated bleeds; treated spontaneous bleeds; and treated joint and target joint bleeds [Cohort A] measure: ABR for treated spontaneous, joint, and target joint bleeds [Cohort A] measure: Annualized FVIII dosage [Cohort A] measure: Proportion of Resolved Target Joints [Cohort A] measure: Mean Change of Total Hemophilia Joint Health Score [Cohort A] measure: FVIII:C levels over time [Cohort A] measure: Mean ABR for all bleeds and treated bleeds [Cohort C] measure: FVIII: C levels over time from Week 26 [Cohort C] measure: Proportion of Participants Who Receive IV Methylprednisolone (IVMP) Prior to Week 8 (Early IVMP) [Cohorts A, B, C] measure: Proportion of Participants Who Receive Secondary Oral Immunomodulation [Cohorts A, B, C] measure: Median Time to First Immunomodulation-related Corticosteroid Dose [Cohorts A, B, C] measure: Median Duration of Secondary Oral Immunomodulation [Cohorts A, B, C] measure: Proportion of Participants with FVIII Inhibitor Development [Cohorts A, B, C] measure: Proportion of participants with Treatment-related AEs of ALT Elevation [Cohorts A, B, C] measure: Proportion of participants with treatment-related AEs of Infusion Reaction [Cohorts A, B, C] measure: Number of participants with abnormal physical exam findings, abnormal vital signs, and abnormal selected clinical laboratory test results [Cohorts A, B, C] measure: Proportion of participants with AEs and SAEs [Cohorts A, B, C] measure: Proportion of participants with AESIs [Cohorts A, B, C] sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Orthopaedic Institute for Children/Orthopaedic Hemophilia Treatment Center status: RECRUITING city: Los Angeles state: California zip: 90007 country: United States name: Doris Quon, MD, PhD role: CONTACT lat: 34.05223 lon: -118.24368 facility: Kaiser Permanente-Oakland Medical Center status: RECRUITING city: Oakland state: California zip: 94611 country: United States name: Tatjana Kolevska, MD role: CONTACT lat: 37.80437 lon: -122.2708 facility: Kaiser Permanente-Roseville Medical Center status: RECRUITING city: Roseville state: California zip: 95661 country: United States name: Tatjana Kolevska, MD role: CONTACT lat: 38.75212 lon: -121.28801 facility: Kaiser Permanente -Sacramento Medical Center status: RECRUITING city: Sacramento state: California zip: 95814 country: United States name: Tatjana Kolevska, MD role: CONTACT lat: 38.58157 lon: -121.4944 facility: Kaiser Permanente -San Francisco Medical Center status: RECRUITING city: San Francisco state: California zip: 94115 country: United States name: Tatjana Kolevska, MD role: CONTACT lat: 37.77493 lon: -122.41942 facility: University of California - San Francisco status: RECRUITING city: San Francisco state: California zip: 94143 country: United States name: Andrew Leavitt, MD role: CONTACT lat: 37.77493 lon: -122.41942 facility: Kaiser Permanente- Santa Clara Medical Center status: RECRUITING city: Santa Clara state: California zip: 94115 country: United States name: Tatjana Kolevska, MD role: CONTACT lat: 37.35411 lon: -121.95524 facility: Kaiser Permanente-Vallejo Medical Center status: RECRUITING city: Vallejo state: California zip: 94589 country: United States name: Tatjana Kolevska, MD role: CONTACT lat: 38.10409 lon: -122.25664 facility: Kaiser Permanente -Walnut Creek Medical Center status: RECRUITING city: Walnut Creek state: California zip: 94596 country: United States name: Tatjana Kolevska, MD role: CONTACT lat: 37.90631 lon: -122.06496 hasResults: False
<\|newrecord\|> nctId: NCT06297473 id: SJ-1050 briefTitle: Physical Attendance Versus Telephone or Video Follow-up in Patients With Non-functioning Pituitary Tumors. acronym: PITCARE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-01-01 date: 2028-08-01 date: 2024-03-07 date: 2024-03-07 name: Zealand University Hospital class: OTHER briefSummary: The primary purpose of this study is to compare the safety of routine telephone assessment versus in-person assessment during a two-year period for patients with non-functioning pituitary adenomas. Secondly, to compare the quality of pituitary care in persons having biochemical assessment once versus twice a year. Thirdly, to assess the rationale of repeated assessment of pituitary function and imaging in patients with small pituitary tumors (microadenomas). conditions: Non-Functional Pituitary Adenoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomized to either intervention or control primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Adverse events (primary outcome) will be established by a blinded adjudication committee.
A committé of external endocrinologist/ophthalmologist will blinded to participant ID/allocation assess all the participants admissions to hospital and assess wether it qualifies as an event whoMasked: OUTCOMES_ASSESSOR count: 812 type: ESTIMATED name: Telephone-/video follow-up name: In-person follow-up measure: Composite outcome of adverse events measure: Thyroid replacement therapy measure: Growth hormone replacement therapy measure: Desmopressin replacement therapy measure: Hormonal replacement therapy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06297460 id: STEPPSPENITENTIARY briefTitle: Adaptation of STEPPS Program for Addressing Emotional Dysregulation and Self-harming Behaviors in Penitentiary Centers overallStatus: ACTIVE_NOT_RECRUITING date: 2022-01-01 date: 2024-12-01 date: 2025-12-01 date: 2024-03-07 date: 2024-03-07 name: Universitat Jaume I class: OTHER name: Centre d'Estudis i Formació Especialtzada Generalitat de Catalunya briefSummary: The overall objective of this study is to assess the feasibility, within the Penitentiary Centers of Catalonia, of adapting the STEPPS program for addressing and preventing emotional dysregulation and self-harming behaviors through an implementation study. conditions: Self Harm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Systems Training for Emotional Predictability & Problem Solving (STEPPS) measure: Level of emotional and behavioral disregulation of patients measure: Type and levels of impulsivity of patients measure: Suicide risk of patients measure: Self-injury frequency, typology and funcionality of patients measure: Degree of hopeless of patients measure: Perceived level of feasibility by professionals measure: Perceived level of acceptability of the intervention by professionals measure: Satisfaction of the intervention by patients measure: Perceived level of adequacy by professionals measure: Barriers and facilitators detected by professionals that are influencing the implementation process - Quantitative information measure: Level of burnout of professionals measure: Barriers and facilitators detected by professionals that are influencing the implementation process - Qualitative information sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rosa city: Castellón De La Plana state: Castellón zip: 12071 country: Spain lat: 39.98567 lon: -0.04935 hasResults: False
<\|newrecord\|> nctId: NCT06297447 id: N-20230073 briefTitle: Keeping it Simple Study (KISS) acronym: KISS overallStatus: RECRUITING date: 2024-03-11 date: 2025-12-31 date: 2026-12 date: 2024-03-07 date: 2024-03-13 name: Bettina Eiger class: OTHER name: University of Southern Denmark name: Aalborg University name: Central Denmark Region name: Vrije Universiteit Brussel briefSummary: Problem: The number of patients living with chronic musculoskeletal (MSK) pain has steadily increased over the past decade with costs rising equally. Long-standing pain is associated with significant maladaptive beliefs about pain, psychological characteristics and associated behaviors which involve structural and functional neurobiological characteristics which share common pathophysiological mechanisms as chronic pain. The investigators recent priority setting partnership investigated the research priorities from 1000 patients with chronic MSK pain, relatives, and clinicians. Better pain education was rated as one of the three most important research areas.
Solution: Pain science education has the potential to target maladaptive psychological and behavioral components that may contribute to the maintenance of chronic pain. The KISS project will evaluate the effect of a pain neuroscience education program (PNE4Adults) on rehabilitation outcomes in patients with chronic MSK pain. This intervention has the potential to change beliefs and behaviors surrounding pain in patients with chronic MSK pain. If this is successful in disrupting maladaptive cycles contributing to chronicity, this may improve outcomes for many thousand citizens. conditions: Musculoskeletal Pain conditions: Chronic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicenter randomized controlled, superiority trial with a 2-group parallel design. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Randomization will be stratified by cite. Block randomization in random concealed block sizes of 4 to 6 (1:1) into two parallel groups is used to avoid imbalance in the randomization between intervention groups. A person not otherwise affiliated with the study will generate the randomization sequence.The randomization will be coded (Group 1 or 2), thus the primary investigator (BE) will not know the code to the groups. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: PNE4Adults - pain science education name: Usual care measure: Musculoskeletal Health Questionnaire (MSK-HQ) measure: Mean Pain intensity measure: Pain interference measure: Concept of pain measure: Pain catastrophizing measure: Fear of movement measure: Patient specific functional limitation measure: Patient impression of change measure: Patient satisfaction with current symptom state measure: Pain Self-efficacy measure: Adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Træningsenheden, Holbæk Municipality status: RECRUITING city: Holbæk state: Region Sjælland zip: 4300 country: Denmark name: Helle B. Hansen, PT role: CONTACT phone: 72363252 email: helha@holb.dk lat: 55.71354 lon: 11.7169 facility: Træningsenheden, Køge Municipality status: RECRUITING city: Køge state: Region Sjælland zip: 4600 country: Denmark name: Annette B. Schlaikjer, PT role: CONTACT phone: +45 51 36 33 78 email: annette.schlaikjer@koege.dk lat: 55.45802 lon: 12.18214 facility: Genoptræningscenteret, Solrød Municipality status: RECRUITING city: Solrød Strand state: Region Sjælland zip: 2680 country: Denmark name: Linda M. Blæsbjerg, PT role: CONTACT phone: +4556182405 email: kolbl@solrod.dk lat: 55.53285 lon: 12.22227 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-06 uploadDate: 2024-03-06T10:23 filename: Prot_000.pdf size: 413728 hasResults: False
<\|newrecord\|> nctId: NCT06297434 id: JH-221-201 briefTitle: Phase 2a Study to Evaluate Safety and Explore Efficacy of J2H-1702 for NASH overallStatus: RECRUITING date: 2023-02-15 date: 2025-01-01 date: 2025-01-01 date: 2024-03-07 date: 2024-03-07 name: J2H Biotech class: INDUSTRY briefSummary: The study aims to evaluate the safety of J2H-1702 compared to the placebo and explore the efficacy of J2H-1702 at Week 12 timepoint after administration compared to baseline in patients with NASH. conditions: Non-alcoholic Steatohepatitis 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: J2H-1702 name: J2H-1702 name: J2H-1702 name: Placebo measure: Changes from baseline in results on MRI-PDFF at week12. measure: Changes from baseline in results on MRE at week12. sex: ALL minimumAge: 19 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: J2H Biotech status: RECRUITING city: Suwon state: Gyeonggi-do zip: 16684 country: Korea, Republic of name: Eunji Byeon role: CONTACT lat: 37.29111 lon: 127.00889 hasResults: False
<\|newrecord\|> nctId: NCT06297421 id: SZYY20240229IBS-D briefTitle: Efficacy and Safety of FMT for the Treatment of IBS-D and Mental Health Comorbidity in Young Adults overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-01 date: 2026-06 date: 2024-03-07 date: 2024-04-23 name: Shenzhen Hospital of Southern Medical University class: OTHER briefSummary: The purpose of this study is to evaluate the efficacy and safety of Fecal Microbiota Transplantation compared with placebo in the treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) and Mental Health Comorbidity in Young Adults. conditions: Irritable Bowel Syndrome With Diarrhea conditions: Fecal Microbiota Transplantation conditions: Mental Health Issue studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 434 type: ESTIMATED name: Fecal Microbiota Transplantation name: Placebo measure: Percentage of Patients Who Were Composite Weekly Responders measure: Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0 measure: Percentage of Patients Who Were Composite Weekly Responders measure: Percentage of Patients Who Were Abdominal Pain Weekly Responder measure: Percentage of Patients Who Were Stool Consistency Weekly Responder measure: Percentage of Patients Who Were Abdominal Bloating Weekly Responder measure: Percentage of Participants Who Were Responders in IBS Symptoms Relief Scale measure: Change from Baseline in the Weekly Average of Worst Abdominal Pain in the Past 24 hours measure: Change from Baseline in the Number of Days per Week with at Least One Stool with Consistency of Type 6 or 7 measure: Change from Baseline in the Number of Stools of Type 6 or 7 per Week measure: Change from Baseline in the Weekly Average of Worst Abdominal Bloating in the Past 24 Hours Score measure: Change from baseline in Irritable Bowel Syndrome Severity Scale (IBS-SSS) Scores measure: Change from baseline in Irritable Bowel Syndrome Quality of Life Scale (IBS-QoL) Total Scores sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Shenzhen Hospital of Southern Medical University city: Shenzhen state: Guangdong zip: 518000 country: China lat: 22.54554 lon: 114.0683 hasResults: False
<\|newrecord\|> nctId: NCT06297408 id: JWCAR029115 briefTitle: Relma-cel for Moderate to Severe Active Systemic Lupus Erythematosus overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-05 date: 2026-05 date: 2024-03-07 date: 2024-03-07 name: Shanghai Ming Ju Biotechnology Co., Ltd. class: INDUSTRY briefSummary: To assess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China. conditions: Systemic Lupus Erythematosus studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Relma-cel measure: DLT rate measure: determine RP2D measure: SELENA-SLEDAI measure: BILAG -2004 measure: PGA (physician global assessment) score sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06297395 id: Cervical Traumatic Inj briefTitle: Subaxial Cervical Traumatic Injuries overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-03-01 date: 2024-03-07 date: 2024-03-07 name: Assiut University class: OTHER briefSummary: The aim of this study is to assess the mid-term outcomes of treating subaxial cervical traumatic injury cases admitted to the Trauma Unit of Assiut University Hospital. conditions: Cervical Injury Spine studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 100 type: ESTIMATED measure: Percentage of improvement measure: Patient Outcomes measure: Complication measure: rehabilitation measure: Complication measure: rehabilitation measure: Complication measure: Complication measure: Complication sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06297382 id: SBU-HEM-PSI-01 briefTitle: Impact of ChatGPT-based Nursing Process Training overallStatus: NOT_YET_RECRUITING date: 2024-03-06 date: 2024-04-24 date: 2025-04-25 date: 2024-03-07 date: 2024-03-07 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: The goal of this randomized controlled study is to determine the impact of ChatGPT based nursing process training on nursing students' clinical decision-making competencies and artificial intelligence anxiety.
Population and Sample: The population of the research consists of senior students studying at Gülhane Faculty of Nursing, University of Health Sciences. Power analysis was performed to determine the number of people to be included in the study. The power of the test was calculated with the G\*Power 3.1 program. In a similar study in the relevant literature, the effect size regarding the change in clinical decision-making level was calculated as 0.898. In order to exceed the 99% value in determining the power of the study; At the 5% significance level and 0.898 effect size, 44 people, 22 people in the groups, need to be reached (df=21; t=1.721). In the research, it was aimed to reach a total of 60 people, 30 people in the groups, considering the high power of the test and the losses. conditions: Nurse-Patient Relations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This research will be conducted as an experimental study with pretest-posttest randomised control group design. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Experimental and control groups will be determined using https:// www.randomizer.org. whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: ChatGPT Based Nursing Process Training measure: Descriptive Information Form measure: Clinical Decision Making Scale in Nursing measure: rtificial Intelligence Anxiety Scale: sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06297369 id: RHDIRB2020110301 REC #250 briefTitle: Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients overallStatus: RECRUITING date: 2024-02-01 date: 2025-02-01 date: 2025-08-01 date: 2024-03-07 date: 2024-03-07 name: Ain Shams University class: OTHER briefSummary: Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients conditions: Cisplatin Adverse Reaction conditions: Cisplatin Nephrotoxicity conditions: Cisplatin Induced Peripheral Neuropathy conditions: Cancer Patients conditions: Cisplatin Ototoxicity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: N acetyl cysteine measure: The occurrence of cisplatin-induced ototoxicity in the form of hearing loss. measure: The occurrence of cisplatin-induced nephrotoxicity. measure: The occurrence of cisplatin-induced peripheral neuropathy. measure: The occurrence of cisplatin-induced peripheral neuropathy. measure: The occurrence of cisplatin-induced peripheral neuropathy. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Clinical Oncology and Nuclear Medicine, Ain Shams University Hospitals, Cairo, Egypt. status: RECRUITING city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06297356 id: YCEYHAN briefTitle: The Effect of Stress Ball Utilisation on Treatment Duration, Dyspnea Severity and Anxiety Level in Nebuliser Therapy overallStatus: RECRUITING date: 2023-10-01 date: 2024-02-19 date: 2024-04-01 date: 2024-03-07 date: 2024-03-07 name: Kirsehir Ahi Evran Universitesi class: OTHER briefSummary: Nebul Therapy is very effective in quickly improving the symptoms of respiratory system diseases. While applying this treatment, patients are expected to complete a sufficient period of time. However, this waiting and the symptoms of the disease may cause anxiety in the patient.
The aim of the study was to enable patients to spend their nebul period actively by using a stress ball. Thus, it was thought that it would make a positive contribution to dyspnea severity and anxiety levels.
The main questions it aims to answer are:
Does using a stress ball contribute positively to nebulizer usage time? Is the use of a stress ball effective in reducing the severity of dyspnea? Is using a stress ball effective in reducing anxiety levels?
For this purpose, participants will be asked to tighten and loosen the stress ball with one hand during the nebuliser therapy.
They will be expected to continue this with at least two nebuliser therapy per day. A control group will be used to determine the effectiveness of the stress ball. This group will not use a stress ball while receiving nebulizer treatment. conditions: Inhalation Therapy; Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled trial primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Stress ball measure: dyspnea severity measure: anxiety levels measure: treatment duration measure: Vital signs: Respiratory rate measure: Vital signs: Pulse measure: Vital signs: Blood pressure measure: saturation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yasemin CEYHAN status: RECRUITING city: Kırşehir state: Center zip: 40100 country: Turkey name: Yasemin CEYHAN, PhD role: CONTACT phone: +9054645898065 email: yasemin-ceyhan@hotmail.com role: CONTACT phoneExt: CEYHAN email: yasemin-ceyhan@hotmail.com name: Yasemin CEYHAN, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.14583 lon: 34.16389 hasResults: False
<\|newrecord\|> nctId: NCT06297343 id: 2023-A02491-44 briefTitle: Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula acronym: MODIFVASC overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-03 date: 2027-03 date: 2024-03-07 date: 2024-04-10 name: GCS Ramsay Santé pour l'Enseignement et la Recherche class: OTHER briefSummary: The purpose of this study is to identify functional vascular changes and clinical factors correlated with the occurrence of short- or medium-term hand ischaemia after arteriovenous fistula creation. conditions: Renal Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 544 type: ESTIMATED name: Creation of an arteriovenous fistula measure: Occurrence of ischaemia of the hand sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Privé des Peupliers city: Paris zip: 75013 country: France lat: 48.85341 lon: 2.3488 hasResults: False
<\|newrecord\|> nctId: NCT06297330 id: PROMESS - SLEEP briefTitle: Sleep for Optimal MEdical StudentS (PROMESS) overallStatus: RECRUITING date: 2023-11-11 date: 2024-09-30 date: 2024-09-30 date: 2024-03-07 date: 2024-03-07 name: Research on Healthcare Performance Lab U1290 class: OTHER briefSummary: Medical students have been shown to have a greater prevalence of poor sleep leading to poorer quality of life than other groups of students. Among medical students, poor sleep quality and insomnia have been associated with higher level of stress, as well as poorer academic performance. Our field surveys carried out in 2022 and 2023 at the Lyon Est medical school make the same alarming observation. They revealed that 53% of students had significant sleep problems.They also showed that students presented high levels of physical and mental fatigue. It is expected that these disorders will significantly degrade their quality of life as well as their health. Indeed, lack of sleep is associated with serious health problems such as illnesses cardiovascular or immune system deficiencies.
The PROMESS - SLEEP project aims to offer solutions to students to improve their sleep during their medical studies. It responds to a demand expressed by students: our field study showed that 40% of 4th year students declared being "very interested and/or interested" in following an intervention that aimed at improving sleep. An early knowledge of sleep optimization tools would allow students to quickly acquire the tools necessary to cope with the difficult conditions encountered during their training and lives of future doctors.The objective of this study is to determine the influence of an intervention program based on sleep improvement and fatigue reduction among medical students. conditions: Health Behavior conditions: Health-Related Behavior conditions: Sleep conditions: Sleep Disorder conditions: Fatigue studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All volunteers will receive an intervention program based on sleep improvement and fatigue reduction. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 45 type: ESTIMATED name: Sleep measure: Perceived level of sleep troubles. Evolution of the score obtained at the Pittsburgh Sleep Questionnaire Inventory (PSQI). measure: Perceived level of sleep troubles. Score obtained at the Pittsburgh Sleep Questionnaire Inventory (PSQI). measure: Epworth Sleepiness scale. Score obtained at the Epworth Sleepiness scale. measure: Multidimensional Fatigue. Score obtained at the Multidimensional Fatigue Inventory (MFI). measure: Reduced composite scale of morningness. Score obtained at the reduced composite scale of morningness (RCSMS). measure: Actimetry records. Time in Bed during the pre-intervention. measure: Actimetry records. Total sleep duration during the pre-intervention. measure: Actimetry records. Sleep efficiency during the pre-intervention. measure: Actimetry records. Sleep Onset Latency during the pre-intervention. measure: Actimetry records. Wake after Sleep Onset during the pre-intervention. measure: Actimetry records. Number of Awakenings during the pre-intervention. measure: Actimetry records. Bedtime during the pre-intervention. measure: Actimetry records. Mid-sleep point during the pre-intervention. measure: Actimetry records. Sleep Onset time during the pre-intervention. measure: Actimetry records. Sleep Inertia during the pre-intervention. measure: Actimetry records. Wake-up time during the pre-intervention. measure: Actimetry records. Sleep regularity index during the pre-intervention. measure: Multidimensional Fatigue. Evolution of the score obtained at the Multidimensional Fatigue Inventory (MFI) during the intervention. measure: Actimetry records. Evolution in Time in Bed during the intervention. measure: Actimetry records. Evolution in Total sleep duration during the intervention. measure: Actimetry records. Evolution in Sleep efficiency during the intervention. measure: Actimetry records. Evolution in Sleep Onset Latency during the intervention. measure: Actimetry records. Evolution in Wake after Sleep Onset during the intervention. measure: Actimetry records. Evolution in Number of Awakenings during the intervention. measure: Actimetry records. Evolution in Mid-sleep point during the intervention. measure: Actimetry records. Evolution in Bed time during the intervention. measure: Actimetry records. Evolution in Sleep Onset Time during the intervention. measure: Actimetry records. Evolution in Sleep Inertia during the intervention. measure: Actimetry records. Evolution in Wake-up Time during the intervention. measure: Actimetry records. Evolution in Sleep regularity index during the intervention. measure: VAS - sleep quantity: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the quantity of sleep. measure: VAS - sleep quality. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) characterizing the sleep quality. measure: VAS - sleep fatigue. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of fatigue. measure: Advices given by the expert. Score obtained on a Likert scale ranging from 1 to 5 characterizing the nature of the advices given by the expert. measure: Likert - expert estimation of student's achievements. Score obtained on a Likert scale ranging from 1 to 3 accessing if the expert estimates that the student has achieve the goals previously set. measure: Likert - expert satisfaction. Scores obtained on a Likert scale ranging from 1 to 5 accessing the expert's satisfaction of his/her intervention. measure: Likert - expert level of comfort. Score assessing the expert comfort levels in participant relationships on a likert scale ranging from 1 to 5. measure: Likert - expert estimation of the overall student's achievements. Score obtained on a Likert scale ranging from 1 to 5 accessing the expert's level of satisfaction on the student's progress. measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the all intervention. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RESHAPE status: RECRUITING city: Lyon zip: 69008 country: France name: Sophie Schlatter, Dr. role: CONTACT phone: 07 68 21 05 51 phoneExt: 33 email: sophie.schlatter@univ-lyon1.fr name: Angèle Métais, Dr. role: CONTACT phone: 06 77 39 89 66 phoneExt: 33 email: angele.metais@univ-lyon1.fr lat: 45.74848 lon: 4.84669 hasResults: False
<\|newrecord\|> nctId: NCT06297317 id: Trailstiff briefTitle: Longitudinal Changes in Achilles Tendon and Medial Gastrocnemius Muscle Architecture During a 156-km Ultradistance Trail Running Event acronym: Trailstiff overallStatus: COMPLETED date: 2021-11-11 date: 2021-11-13 date: 2024-02-01 date: 2024-03-07 date: 2024-03-07 name: University Hospital, Caen class: OTHER briefSummary: This study aimed to assess the longitudinal changes in triceps surae muscle-tendon architecture to an ultra distance trail running. Experienced trail runners (N=55, 78% men, age: 45.2 \[13.5\] years) participated in a 156-km trail run (6000m climbing) consisting in six 26-km laps. The resting architectural properties of triceps surae muscle-tendon were measured using ultrasound imaging for Achille tendon cross-sectional area (AT CSA), medial gastrocnemius muscle pennation angle, thickness, length and fiber length. Measurements were performed the day before the race (Baseline), at 52-km (T1), at 104-km (T2), at 156-km (T3) and 12 hours after the race (H12). conditions: Achilles Tendinopathy conditions: Calf Injury conditions: Sport Injury conditions: Lower Limb Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 55 type: ACTUAL name: Ultrasound measurement of triceps surae muscle-tendon architecture measure: Achille tendon cross sectional area measure: Medial gastrocnemius thickness measure: Medial gastrocnemius pennation angle measure: Medial gastrocnemius fascicle length measure: Medial gastrocnemius muscle length measure: Finisher status measure: Average speed sex: ALL minimumAge: 25 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Caen Normandie city: Caen zip: 14000 country: France lat: 49.18585 lon: -0.35912 hasResults: False
<\|newrecord\|> nctId: NCT06297304 id: PROMESS - PHYSICAL ACTIVITY briefTitle: Sedentary Behaviors Reduction and Physical Activity Promotion for Optimal Medical StudentS overallStatus: RECRUITING date: 2023-11-11 date: 2024-09-30 date: 2024-09-30 date: 2024-03-07 date: 2024-03-12 name: Research on Healthcare Performance Lab U1290 class: OTHER briefSummary: Medical students are under great competitive pressure throughout their studies. Our field surveys conducted in 2022 and 2023 at the Lyon Est Faculty of Medicine revealed that 78% of 482 students showed an excessive sedentary lifestyle compared to the threshold set by WHO. It is expected that a low level of physical activity and/or too high a sedentary lifestyle deteriorates significantly their quality of life and their health. In 2014, a British survey of 356 students in Medicine showed that lack of physical activity was an major predictor of burnout symptoms. Numerous studies show that regular physical activity improves the mental health of students and their cognitive performance.
The PROMESS - PHYSICAL ACTIVITY project aims to offer solutions to students to decrease their sedentary behavior and to improve their physical activity level during their medical studies through an intervention program. From a long term perspective, this intervention may also prevent disorders related to inadequate levels of physical activity and/or sedentary behavior. It responds to a demand expressed by students : our previous field study showed that 45% of fourth-year students declared being "very interested and/or interested" in following an intervention that aimed at improving physical activity. The objective of this study is to determine the influence of an intervention based on sedentary behavior reduction and physical activity promotion among medical students. conditions: Health Behavior conditions: Health-Related Behavior conditions: Physical Inactivity conditions: Sedentary Behavior conditions: Sedentary Time studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All volunteers will receive a physical activity and sedentary management intervention. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 45 type: ESTIMATED name: Sedentary and physical activity behaviors measure: Perceived level of sedentary : Evolution of the score obtained at the Rapid Physical Activity Questionnaire (RPAQ) on sedentary behaviors. measure: Perceived level of physical activity : Score obtained at the Global Physical Activity Questionnaire (GPAQ) on physical activity levels. measure: Perceived level of sedentary : Score obtained at the Rapid Physical Activity Questionnaire (RPAQ) on sedentary behaviors. measure: Actimetry records.Total activity during the pre-intervention. measure: Actimetry records. Moderate-to-vigorous Physical Activity (MVPA) during the pre-intervention. measure: Actimetry records. Light Physical Activity during the pre-intervention. measure: Actimetry records. Steps count during the pre-intervention. measure: Actimetry records. Energy expenditure during the pre-intervention. measure: Actimetry records. Number of sedentary breaks during the pre-intervention. measure: Actimetry records. Sedentary time during the pre-intervention. measure: Actimetry records. Number of prolonged sedentary bouts during the pre-intervention. measure: Actimetry records.Vector of the dynamic body acceleration (VeDBA) during the pre-intervention. measure: Body composition markers. Body Mass Index (BMI) during the pre-intervention. measure: Body composition markers. Skeletal muscle mass measured by bioimpedancemetry during the pre-intervention. measure: Body composition markers. Fat mass measured by bioimpedancemetry during the pre-intervention. measure: Body composition markers. Total body hydration measured by bioimpedancemetry during the pre-intervention. measure: Physical Fitness markers - Strength. The force developed during a maximal isometric contraction of the quadriceps during the pre-intervention. measure: Physical Fitness markers markers - Power. Height of jump during the pre-intervention. measure: Physical Fitness markers - Power. Time of flight during the pre-intervention. measure: Physical Fitness markers - Power. Relative Power during the pre-intervention. measure: Physical Fitness markers - Endurance. Speed through the endurance test during the pre-intervention. measure: Physical Fitness markers - Endurance. VO2max through the endurance test during the pre-intervention. measure: Physical Fitness markers - Endurance. Heart rate during the endurance test during the pre-intervention. measure: Perceived level of physical activity : Evolution of the score obtained at the Global Physical Activity Questionnaire (GPAQ) on physical activity level. measure: Actimetry records. Evolution in Total activity during the intervention. measure: Actimetry records. Evolution in Moderate-to-vigorous physical activity (MVPA) during the intervention. measure: Actimetry records. Evolution in Light physical activity measured in min/day during the intervention. measure: Actimetry records. Evolution in Step Count during the intervention. measure: Actimetry records. Evolution in Energy expenditure during the intervention. measure: Actimetry records. Evolution in number of sedentary breaks during the intervention. measure: Actimetry records. Evolution in Number of prolonged sedentary bouts during the intervention. measure: Actimetry records. Evolution in the vector of the dynamic body acceleration (VeDBA) during the intervention. measure: Body composition markers. Evolution in BMI during the intervention. measure: Body composition markers. Evolution in fat mass measured by bioimpedancemetry during the intervention. measure: Body composition markers: Impedance metric measures. Evolution in skeletal muscle mass measured by bioimpedancemetry during the intervention. measure: Body composition markers: Impedance metric measures. Evolution in total body hydration measured by bioimpedancemetry during the intervention. measure: VAS - physical fitness: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of physical fitness. measure: VAS - physical activity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of physical activity. measure: VAS - sedentary behaviours. Evolution of the scores obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of sedentary behaviours. measure: Advices given by the expert. Score obtained on a Likert scale ranging from 1 to 5 characterizing the nature of the advices given by the expert. measure: Likert - expert estimation of student's achievements. Score obtained on a Likert scale ranging from 1 to 3 accessing if the expert estimates that the student has achieve the goals previously set. measure: Likert - expert satisfaction. Scores obtained on a Likert scale ranging from 1 to 5 accessing the expert's satisfaction of his/her intervention. measure: Likert - expert level of comfort. Score assessing the expert comfort levels in participant relationships on a likert scale ranging from 1 to 5. measure: Likert - expert estimation of the overall student's achievements. Score obtained on a Likert scale ranging from 1 to 5 accessing the expert's level of satisfaction on the student's progress. measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the all intervention. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RESHAPE status: RECRUITING city: Lyon zip: 69008 country: France name: Sophie Schlatter, Dr. role: CONTACT phone: 07 68 21 05 51 phoneExt: 33 email: sophie.schlatter@univ-lyon1.fr name: Angèle Métais, Dr. role: CONTACT phone: 06 77 39 89 66 phoneExt: 33 email: angele.metais@univ-lyon1.fr lat: 45.74848 lon: 4.84669 hasResults: False
<\|newrecord\|> nctId: NCT06297291 id: CLN0984 briefTitle: Global Paradise System US Post Approval Study acronym: US GPS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-09 date: 2031-07 date: 2024-03-07 date: 2024-03-07 name: ReCor Medical, Inc. class: INDUSTRY briefSummary: The objective of the Global Paradise® System US Post Approval Study (US GPS) is to evaluate the real-world use of the Paradise Ultrasound Renal Denervation System indicated for patients who are unable to lower their blood pressure with lifestyle changes and medication. This system is comprised of a catheter, cable, balloon, and generator and has received FDA approval in the United States. Information collected in this study will be analyzed to better understand the long-term safety and effectiveness of treatment with the Paradise System for patients with high blood pressure. conditions: Hypertension conditions: Cardiovascular Diseases conditions: Vascular Diseases studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Paradise Ultrasound Renal Denervation Treatment measure: Co-Primary Endpoint #1: Group Mean BP reduction measure: Co-Primary Endpoint #2: Subject Responder measure: Change in mean home systolic/diastolic BP in mmHg measure: Change in mean office systolic/diastolic BP in mmHg measure: Change in home and office pulse pressure measure: Change in the number and/or dosage and/or type of antihypertensive medications taken measure: Change in patient reported outcomes measure: Percentage of patients who are controlled as measured by various cut points of home BP (control to be assessed as both < 130 mmHg systolic and <135 mmHg systolic) office BP (control to also be assessed as <130 mmHg and <140 mmHg systolic) measure: Percentage of patients who demonstrate a reduction in home systolic BP of ≥ 5mmHg, ≥ 10 mmHg and ≥ 15 mmHg measure: Percentage of patients who demonstrate a reduction in office systolic BP of ≥ 5mmHg, ≥ 10 mmHg and ≥ 15 mmHg measure: Change in home and office heart rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

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