Datasets:

hackint0sh
/

New-Dataset

Tags:

License:

Dataset card Viewer Files Files and versions Community

Dataset Viewer

Auto-converted to Parquet

View in Dataset Viewer

Viewer

Split (1)

train · 22k rows

Record stringlengths 1 197k
<\|newrecord\|> nctId: NCT06390072 id: 23-X-71 briefTitle: Project Hypnos: The Impact of a Brief Hypnosis Intervention on Single-limb Dynamic Balance in People With Chronic Ankle Instability overallStatus: COMPLETED date: 2023-09-25 date: 2023-11-27 date: 2023-11-27 date: 2024-04-29 date: 2024-04-29 name: Ohio University class: OTHER briefSummary: This study will determine the relationship of one's self-reported awareness of their body and their ankle motor control for people with chronic ankle instability. This study will further identify the correlates between certain psychological characteristics (i.e., fear and anxiety) and autonomic nervous system arousal (i.e., heart rate variability). Furthermore, this study will elucidate the potential impact of a brief hypnosis practice on balance performance. conditions: Ankle Sprains conditions: Motor Coordination or Function; Developmental Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This basic experimental pilot study involved a randomized cross-over design of two brief interventions with a 1:1 allocation ratio primaryPurpose: TREATMENT masking: NONE count: 24 type: ACTUAL name: Self-Hypnosis name: Ankle Education measure: Balance test 1 measure: Balance test 2 measure: Heart rate variability measure: Ankle disability measure 1 measure: Ankle disability measure 2 measure: Interoceptive awareness measure 1 measure: Interoceptive awareness measure 2 measure: Emotional Distress-Anxiety measure: Kinesiophobia measure: Pain self-efficacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio University city: Athens state: Ohio zip: 45701 country: United States lat: 39.32924 lon: -82.10126 hasResults: False
<\|newrecord\|> nctId: NCT06390059 id: EF-39 id: EF-39 type: OTHER domain: Sponsor id: 2022-003157-55 type: EUDRACT_NUMBER briefTitle: EF-39 PANOVA-4: Study of Tumor Treating Fields Concomitant With Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-LineTreatment for Metastatic Pancreatic Ductal Adenocarcinoma overallStatus: RECRUITING date: 2023-08-28 date: 2026-08 date: 2026-08 date: 2024-04-29 date: 2024-04-29 name: NovoCure GmbH class: INDUSTRY briefSummary: The PANOVA-4 study is designed to evaluate the safety and efficacy of Tumor Treating Fields (TTFields) therapy together with atezolizumab, gemcitabine and nab-paclitaxel, for the treatment of metastatic pancreatic cancer. The study is intended for patients who have been diagnosed with metastatic pancreatic cancer and have not received prior systemic therapy. conditions: Metastatic Pancreatic Ductal Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, open-label, single arm, multi-center, historical control pilot study. primaryPurpose: TREATMENT masking: NONE count: 76 type: ESTIMATED name: Tumor Treating Fields name: Atezolizumab name: Gemcitabine name: nab-paclitaxel measure: Disease control rate (DCR) measure: Overall survival (OS) measure: Progression-free survival (PFS) measure: 1-Year survival rate measure: Objective response rate (ORR) measure: Progression free survival at 6 months (PFS6) measure: Duration of response (DOR) measure: Rate of of patients with treatment emergent adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Vall d'Hebron status: RECRUITING city: Barcelona zip: 08035 country: Spain name: Teresa Macarulla Mercade role: CONTACT phone: 34 (93) 274 6085 email: tmacarulla@vhebron.net lat: 41.38879 lon: 2.15899 facility: University Hospital Foundation Jimenez Diaz status: RECRUITING city: Madrid zip: 28040 country: Spain name: Angela Lamarca Lete role: CONTACT phone: 34 951 504800 email: angela.lamarca@quironsalud.es name: 1 role: CONTACT lat: 40.4165 lon: -3.70256 facility: Clara Campal Comprehensive Cancer Center (CIOCC) status: RECRUITING city: Madrid zip: 28050 country: Spain name: Antonio Cubillo Gracian role: CONTACT phone: 34 91 756 7800 email: acubillo@hmhospitales.com lat: 40.4165 lon: -3.70256 facility: Regional University Hospital of Malaga status: RECRUITING city: Málaga zip: 29010 country: Spain name: Inmaculada Ales role: CONTACT phone: 34 951308129 email: inales@hotmail.com lat: 36.72016 lon: -4.42034 facility: University Clinic of Navarra - Pamplona status: RECRUITING city: Pamplona zip: 31008 country: Spain name: Mariano Ponz-Sarvise role: CONTACT phone: 34 948 255 400 email: mponz@unav.es lat: 42.81687 lon: -1.64323 hasResults: False
<\|newrecord\|> nctId: NCT06390046 id: 1072.6120.135.2023 briefTitle: Opioid-free Anesthesia, Optimization of Anesthesia After Bariatric Surgery overallStatus: RECRUITING date: 2024-03-14 date: 2025-12-31 date: 2025-12-31 date: 2024-04-29 date: 2024-04-29 name: Jagiellonian University class: OTHER briefSummary: Total intravenous general anesthesia and combined general anesthesia are recognized methods used during anesthesia. They allow you to effectively control pain and reduce the number of complications associated with taking large doses of opioid drugs. It should be emphasized that both methods of anesthesia are currently approved for use in routine anesthetic practice, and only the experience, knowledge and preferences of the anesthesiologist determine which technique will be used in a given patient. Both techniques are used in everyday anesthetic practice, but there is no conclusive scientific data confirming the superiority of either method in patients undergoing bariatric surgery, therefore currently only the individual experience, knowledge and preferences of the anesthesiologist determines which technique will be used in a given patient. conditions: Analgesics, Opioid conditions: Anesthesia; Adverse Effect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study group will be male and female patients, ASA II or III, over 18 years of age and under 75 years of age. Each patient will undergo abdominal (bariatric) surgery. primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Intubation name: TIVA versus Inhalation measure: compare the effectiveness of analgesia measure: determine whether modern technologies such as videolaryngoscopy shorten intubation time. measure: incidence of postoperative nausea and vomiting sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jagiellonian University status: RECRUITING city: Kraków state: Malopolskie zip: 31501 country: Poland name: Tomasz Skladzien, phd md role: CONTACT phone: 506602250 phoneExt: 48 email: t.skladzien@interia.pl lat: 50.06143 lon: 19.93658 hasResults: False
<\|newrecord\|> nctId: NCT06390033 id: ITS/133/21 briefTitle: Biomechanical Study of Different Prostheses for Unilateral Transtibial Amputees During Indoor and Outdoor Activities overallStatus: ENROLLING_BY_INVITATION date: 2023-06-30 date: 2024-04-30 date: 2024-06-30 date: 2024-04-29 date: 2024-04-29 name: The Hong Kong Polytechnic University class: OTHER briefSummary: The goal of this observational study is to evaluate and compare the performance of two prosthetic feet for unilateral transtibial amputees during both indoor and outdoor activities. The main research questions aim to answer are:
1. Can a low-cost prosthetic foot enhance gait mechanics and physical performance in individuals who have undergone traumatic unilateral transtibial amputation, as compared to the traditional K2 - K3 prosthetic feet currently available on the market, during both indoor and outdoor activities?
2. Can the low-cost prosthetic foot meet user satisfaction levels after traumatic unilateral transtibial amputation, when compared to the traditional K2 - K3 prosthetic foot on the market?
Participants will be asked to do
1. Prior to the commencement of the experiment, a professional prosthetist and orthotist will conduct all fitting and alignment procedures for the transtibial amputees. Participants will then be given a two to three-week period to train and acclimate to the individual socket alignment and prosthetic foot.
2. Participants are asked to refrain from consuming caffeine or any stimulants for 24 hours before the tests.
3. Participants will be required to perform the Berg Balance Test.
4. Participants will undergo a series of clinical tests, including: 1) Time to Go Up (measured in seconds), 2) Four Square Step Test (measured in seconds), 3) 10-Meter Walk Test (measured in seconds), 4) Eye Close Standing, 5) Tandem Test, and 6) Functional Reach Test. Each test will be conducted three times. The test items of 4) and 5) will be performed on a force plate (Bertect, Ohio, USA) with dimensions of 400 x 600 mm and a capturing frequency of 1,000 Hz.
5. Participants will be asked to walk on a force plate (AMTI, Advanced Mechanical Technology, Inc., Watertown, USA) at a fixed walking speed of 1.11 ± 0.11m/s, allowing the foot to land naturally on the force plate. Five trials of the gait cycle with a clean foot will be used for analysis.
6. Participants will perform the Counter Movement Jump Test three times with maximum effort on the force plate (Bertect, Ohio, USA), which will be performed without a hand swing.
7. Participants will be asked to perform a 2-minute walking test on flat concrete ground, stairs, and a ramp, respectively.
8. Finally, participants will be asked to complete the Locomotion Capabilities Index questionnaire. conditions: Amputation conditions: Prosthesis User studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 6 type: ESTIMATED name: Prosthetic foot measure: Basic mobility function with two prostheses by Berg Balance Test measure: Basic mobility function with two prostheses by Time to Go Up measure: Basic mobility function with two prostheses by Four Square Step Test measure: Basic mobility function with two prostheses by 10-meter Walk Test measure: Stability index with two prostheses by Eye Close Standing measure: Stability index with two prostheses by Tandem Test measure: Functional Reach Test measure: Gait symmetry analysis of lower limb joint angle measure: Gait symmetry analysis of lower limb joint power measure: Gait symmetry analysis of lower limb joint moment measure: Walking feasibility with two prostheses measure: Jump feasibility with two prostheses measure: Subjective evaluation by Locomotion Capabilities Index questionnaire sex: ALL minimumAge: 36 Years maximumAge: 64 Years stdAges: ADULT facility: The Hong Kong Polytechnic University city: Kowloon zip: 999077 country: Hong Kong lat: 22.31667 lon: 114.18333 hasResults: False
<\|newrecord\|> nctId: NCT06390020 id: NL84880.091.23 briefTitle: Mindfulness-Based Stress Reduction (MBSR) for People High on the Personality Trait Sensory Processing Sensitivity: A Mixed Methods Study acronym: MindSens overallStatus: RECRUITING date: 2024-01-15 date: 2024-12 date: 2024-12 date: 2024-04-29 date: 2024-04-29 name: Radboud University Medical Center class: OTHER briefSummary: This study investigates the efficacy of MBSR training in alleviating stress-related symptoms among individuals with high sensory processing sensitivity. Participants will be randomly allocated to either the MBSR group or the control group.
The primary hypothesis is that participants in the MBSR group, relative to control group, will have lower depression-anxiety-stress scores post-intervention, after controlling for baseline scores. The secondary hypothesis is that in the MBSR group, relative to control group, other mental health, physical health and well-being outcomes, as well as potential mindfulness mechanisms will also improve, after controlling for baseline scores. conditions: Sensory Processing Sensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 52 type: ESTIMATED name: MBSR measure: Change from Baseline to Post-intervention in self-reported depression, anxiety, and stress measure: Change from Baseline to Post-intervention in self-reported well-being measure: Change from Baseline to Post-intervention in self-reported burnout symptoms measure: Change from Baseline to Post-intervention in self-reported physical symptoms measure: Change from Baseline to Post-intervention in self-reported overstimulation measure: Change from Baseline to Post-intervention in self-reported mindfulness measure: Change from Baseline to Post-intervention in self-reported attention regulation measure: Change from Baseline to Post-intervention in self-reported strategies for cognitive emotion regulation measure: Change from Baseline to Post-intervention in self-reported body awareness measure: Change from Baseline to Post-intervention in self-reported self-compassion measure: Change from Baseline to Post-intervention in self-reported sensory processing sensitivity measure: Perceived facilitators, barriers, effects, and mechanisms of participating in the MBSR training sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Radboudumc Center for Mindfulness status: RECRUITING city: Nijmegen state: Gelderland zip: 6525 GC country: Netherlands name: Anne Speckens, prof. dr. role: CONTACT phone: (024) 36 68 456 email: mindfulness@radboudumc.nl lat: 51.8425 lon: 5.85278 hasResults: False
<\|newrecord\|> nctId: NCT06390007 id: 24916 briefTitle: The Efficacy of Acupuncture in the Management of Postoperative Pain in the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-11 date: 2024-12 date: 2024-04-29 date: 2024-04-29 name: Indonesia University class: OTHER briefSummary: Pain is an unpleasant sensory and emotional experience resulting from tissue damage. Pain management is typically conducted according to the World Health Organization (WHO) pain management ladder. Analgesics administered to pediatric patients vary in dosage and type, but these analgesics often have significant side effects. The acupuncture technique using press needles is a non-pharmacological pain therapy modality that has been studied for its ability to reduce the use of analgesic drugs, thereby potentially decreasing side effects associated with analgesic use.
The study was conducted using a randomized controlled trial (RCT) design involving 70 pediatric postoperative patients aged 1-18 years who were admitted to the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital. Subjects were divided into two groups: a control group and an experimental group. The control group received standard analgesic therapy and sham press needle application (a patch resembling a press needle without a needle), while the experimental group received standard analgesic therapy and press needle application at acupuncture points after the patient had been in the Pediatric Intensive Care Unit for 24 hours. Pain scale monitoring was conducted at 1, 6, 24, 48, and 72 hours using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale for children aged 1-8 years, and the Numeric Rating Scale (NRS) for children over 8 years old.
This study hypothesizes that the acupuncture technique using press needles can reduce the pain scale in pediatric postoperative patients, leading to a decrease in the use of analgesics and a reduction in side effects associated with analgesic use. conditions: Pain, Postoperative conditions: Pediatric Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 70 type: ESTIMATED name: Sham press needle name: Press needle acupuncture measure: Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale measure: Numeric Rating Scale (NRS) pain scale sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: RSUPN Dr. Cipto Mangunkusumo city: Jakarta Pusat state: DKI Jakarta zip: 10430 country: Indonesia name: Irene Yuniar role: CONTACT phone: +6281380327808 email: irene.tambunan@yahoo.co.id lat: -6.1818 lon: 106.8223 hasResults: False
<\|newrecord\|> nctId: NCT06389994 id: 23-021041 briefTitle: Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy overallStatus: RECRUITING date: 2024-04-01 date: 2026-04-02 date: 2026-10-01 date: 2024-04-29 date: 2024-04-29 name: Children's Hospital of Philadelphia class: OTHER briefSummary: Patients with IgE mediated food Allergy have elevated risk of eosinophilic esophagitis, and new therapies like oral immunotherapy (OIT) carry additional risk of Eosinophilic Esophagitis (EoE). The goal of this study is to investigate the Esophageal String Test (EST) as a screening tool for Eosinophilic Esophagitis (EoE) during OIT therapy. Investigators will compare the efficacy of the Esophageal String Test to symptom assessment using a validated patient reported symptom questionnaire, the Pediatric Eosinophilic Esophagitis Symptom Score (PEESS) v2.0. Investigators will utilize these tools to screen patients at their baseline visit prior to the start of OIT, then at the 3- and 6-month OIT follow-up visits. conditions: Eosinophilic Esophagitis (EoE) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 75 type: ESTIMATED name: Esophageal String Test measure: Esophageal String Test measure: Prevalence of Eosinophilic Esophagitis measure: Eosinophilic Esophagitis Symptoms sex: ALL minimumAge: 7 Years maximumAge: 17 Years stdAges: CHILD facility: The Children's Hospital of Philadelphia status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Sharon A Carbonara, MS, BSN, RN role: CONTACT phone: 267-426-8603 email: carbonara@chop.edu lat: 39.95233 lon: -75.16379 hasResults: False
<\|newrecord\|> nctId: NCT06389981 id: 1692052 briefTitle: Co-Design and Pilot Testing of Peer-led Community Outreach to Improve Equity, Veteran-Centeredness and Uptake of Lung Cancer Screening acronym: VPC overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-02-28 date: 2025-06-30 date: 2024-04-29 date: 2024-04-29 name: VA Boston Healthcare System class: FED briefSummary: Co-design will be implemented to develop an innovative, Veteran-centered intervention (Vet Peer Connects program) that meets the needs of Black Veterans.
Next, a feasibility pilot test of the Vet Peer Connects program will be conducted. The Peer will lead up to 4 group lung cancer screening orientations in community partner sites to reach around 40 lung cancer screening eligible Black Veterans. The Peer will provide one-to-one tailored support to up to 15 Veterans (coaching, goal-setting, navigation to access Veterans Affairs lung cancer screening). Then, the study team will evaluate program delivery through ethnographic observation and field notes, Peer activity logs, and weekly check-ins between the study team and Peer. Investigators will interview Veteran participants, community partners, and lung cancer screening clinical staff to explore feasibility and acceptability of the Vet Peer Connects program and solicit suggestions for improvement. Preliminary data on the outcomes of the Vet Peer Connects program will be collected by study team through administering surveys to assess change in Social Cognitive Theory constructs, and extracting lung cancer screening uptake and tobacco treatment 3 months post enrollment from VA's Corporate Data Warehouse. This work will inform a subsequent multi-site stepped-wedge trial to assess effectiveness, implementation, and cost of the Vet Peer Connects program in VA lung cancer screening sites and neighboring branches of the National Association for Black Veterans conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 40 type: ESTIMATED name: Veterans peer connect Program measure: Lung Cancer Screening Uptake measure: Tobacco cessation Treatment measure: Stigma Related to Smoking measure: Perceived support from peer measure: Lung Cancer Screening Knowledge measure: Lung Cancer Screening Fatalism measure: Trust in VA measure: Lung Cancer Self-efficacy measure: General Cancer Self-efficacy measure: Intention to engage in shared decision making measure: Motivation to quit smoking measure: Intention to undergo lung cancer screening sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06389968 id: 2023-491-S-KH briefTitle: Light Stimulation to Improve Visual Function After Optic Neuritis in Persons With Multiple Sclerosis acronym: ONSTIM overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2025-12-31 date: 2025-12-31 date: 2024-04-29 date: 2024-04-29 name: Technical University of Munich class: OTHER briefSummary: The aim of this monocentric randomized controlled intervention study is to improve visual function in persons with multiple sclerosis (pwMS) following optic neuritis (neuritis nervi optici, NNO) by means of a light stimulation.
In the treatment arm, two 80-second light stimulations are to be administered daily for 12 days in 25 pwMS following recent NNO (1-3 months). For the standardized application of light stimulation in the sense of standardized training, the light stimulation is to be carried out by watching a generated flicker video on a mobile phone. In a sham-intervened control group (n=25), the spontaneous course after NNO will be recorded in parallel. Intensive neuronal stimulation of the visual pathway will be used to stimulate regenerative processes, which will be recorded by means of changes in high-contrast visual acuity (primary endpoint). Secondary endpoints are changes in a colored-contrast test, in 2.5% low contrast visual acuity (LCVA), the P100 conduction latency of visual evoked potentials, and retinal layer thicknesses and vessel densities measured in optical coherence tomography (OCT) and OCT angiography (OCTA). These physiological parameters should help to understand the underlying processes of a potentially altered visual performance. conditions: Multiple Sclerosis, Relapsing-Remitting conditions: Optic Neuritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: sham-controlled primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: Light stimulation name: Sham light stimulation measure: High contrast visual sensitivity measure: Low contrast visual sensitivity measure: VEP measure: OCT measure: OCT Angiography measure: Color contrast sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06389955 id: TP-3654-103 briefTitle: Assessment of Relative Bioavailability and Effect of Food on Capsule and Tablet Formulations of TP-3654 overallStatus: COMPLETED date: 2023-05-22 date: 2023-08-01 date: 2023-08-24 date: 2024-04-29 date: 2024-04-29 name: Sumitomo Pharma America, Inc. class: INDUSTRY briefSummary: This study comprised of 2 parts, Part A and Part B. Part B will only be conducted if the relative bioavailability of the tablet formulation was at least 70% of the capsule formulation. conditions: Effect of Drug studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 12 type: ACTUAL name: TP 3654 measure: Part A - The maximum concentration (Cmax) of TP-3654 in a capsule formulation measure: Part A - The area under the curve (AUC) of TP-3654 in a capsule formulation measure: Part A - Ratio of Peak Plasma Concentration (Cmax) of TP-3654 tablet versus TP-3654 capsule under fasted conditions measure: Part B - The maximum concentration (Cmax) of TP-3654 in a tablet formulation measure: Number of participants with Treatment Emergent Adverse Events (TEAE) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Frontage Investigative Site city: Secaucus state: New Jersey zip: 07094 country: United States lat: 40.78955 lon: -74.05653 hasResults: False
<\|newrecord\|> nctId: NCT06389942 id: 9MW3011-2022-CP101 briefTitle: Single Ascending Dose Study of 9MW3011 in Chinese Healthy Subject overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-10 date: 2024-04 date: 2024-04 date: 2024-04-29 date: 2024-04-29 name: Mabwell (Shanghai) Bioscience Co., Ltd. class: INDUSTRY briefSummary: The objectives of the study are to evaluate the safety , tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single ascending intravenous (IV) doses of 9MW3011 in Chinese healthy volunteers. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 48 type: ACTUAL name: 9MW3011 name: 9MW3011 placebo measure: Adverse Event(including serious adverse event) measure: Number of subjects with abnormal vital signs measure: Number of subjects with abnormal clinically significant results from physical examination measure: Number of subjects with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters measure: Number of subjects with abnormal clinically significant clinical laboratory results measure: Cmax measure: AUC0-t measure: AUC0-∞ measure: Tmax measure: λz measure: t1/2z measure: Vz measure: CL measure: MRT measure: Pharmacodynamic(PD)parameters-hepcidin measure: PD parameters-serum iron measure: PD parameters-TSAT measure: Anti-drug antibodies(ADA) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PKUcare Luzhong Hospital city: Zibo state: Shandong country: China lat: 36.79056 lon: 118.06333 hasResults: False
<\|newrecord\|> nctId: NCT06389929 id: IU-HB-RK-02 briefTitle: Do the Health Education Materials Developed in the Gynecology and Diseases Nursing Course Affect Students' Teaching Material Motivation and Material Design Self-Efficacy Beliefs? overallStatus: COMPLETED date: 2023-10-30 date: 2024-01-20 date: 2024-01-28 date: 2024-04-29 date: 2024-04-29 name: Inonu University class: OTHER briefSummary: Purpose: This study aimed to examine the effect of health education material developed by nursing students in gynecological health and disease nursing on students' teaching material motivation and material design self-efficacy belief.
Method: The study was conducted as a prospective randomized controlled study. n=86 (43=control, 43=intervention) students who took the Women's Health and Diseases Nursing course at Bartın University Faculty of Health Sciences Nursing Department between 30.10.2023-20.01.2024 and volunteered to participate in the study were randomized. It was conducted in two groups: intervention and control.In the research, data will be collected with the Data Collection Form prepared by reviewing the literature, Instructional Material Motivation Scale and Material Design Self-Efficacy Belief Scale. Descriptive statistics, Student t-test, Mann-Whitney U Test, Wilcoxon Signed Rank Test and Pearson correlation tests will be used to evaluate the data. conditions: Nursing Caries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective randomized controlled n = 86 (43 = control, 43 = intervention) students who took the Women's Health and Diseases Nursing course at Bartın University, Faculty of Health Sciences, Department of Nursing and volunteered to participate in the study were randomly assigned to two groups: intervention and control. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 92 type: ACTUAL name: Education measure: Instructional Material Motivation Scale measure: Material Design Self-Efficacy Belief Scale sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Simge OZTURK city: Bartin state: None Selected zip: 74100 country: Turkey lat: 41.63583 lon: 32.3375 hasResults: False
<\|newrecord\|> nctId: NCT06389916 id: EU-PHX-RCT-001 briefTitle: Euclid Phoenix Lens Design Trial overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-01 date: 2024-04 date: 2024-04 date: 2024-04-29 date: 2024-04-29 name: Euclid Systems Corporation class: INDUSTRY briefSummary: The "first fit" success rate of the current Euclid orthokeratology "MAX" lens design will be compared to that of the new Euclid orthokeratology MAX "Phoenix" lens design in 30 children. conditions: Myopia conditions: Cornea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Euclid orthokeratology MAX (current design) name: Euclid orthokeratology MAX Phoenix (new design) measure: First fit success rate sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Insight Vision Center Optometry city: Costa Mesa state: California zip: 92626 country: United States lat: 33.64113 lon: -117.91867 facility: Dau Family Eye Care city: Saint Johns state: Florida zip: 32259 country: United States lat: 30.0815 lon: -81.54774 facility: Cornea and Contact Lens Institute of Minnesota city: Edina state: Minnesota zip: 55436 country: United States lat: 44.88969 lon: -93.34995 facility: Somerset Eye Care city: North Brunswick state: New Jersey zip: 08902 country: United States lat: 40.454 lon: -74.482 facility: Treehouse Eyes city: Tysons Corner state: Virginia zip: 22182 country: United States lat: 38.91872 lon: -77.23109 hasResults: False
<\|newrecord\|> nctId: NCT06389903 id: 2018-A00185-50 briefTitle: Subthalamic Nucleus Stimulation Electrode and Psychiatric Lesion Effects in Parkinson's Disease acronym: PSYLES-STIM overallStatus: COMPLETED date: 2019-06-04 date: 2020-07-03 date: 2021-10-05 date: 2024-04-29 date: 2024-04-29 name: Centre Hospitalier du Rouvray class: OTHER_GOV briefSummary: This is a pilot, prospective, monocentric study concerning 15 Parkinson's disease patients requiring deep brain stimulation implantation.
The primary objective is to evaluate the psychiatric lesion effects of deep brain stimulation in patients with Parkinson's disease, using the Young Mania Rating Scale (YMRS), Big Five Inventory and the Hamilton Depression Rating Scale (HAMD 21). conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ACTUAL name: assessment measure: Assessment of change of mania symptoms measure: Assessment of change of depressive symptoms measure: Assessment of change of Behavior measure: Assessment of change of Impulsivity measure: Assessment of change of Apathy measure: Assessment of personality measure: Assessment of executive functions measure: Assessment of confusion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marie Desbordes, MD city: Sotteville Les Rouen zip: 76300 country: France lat: 49.40972 lon: 1.09005 hasResults: False
<\|newrecord\|> nctId: NCT06389890 id: PaSuTE briefTitle: Pancreatic Surgery - Optimal Caseload Thresholds and Predictive Accuracy acronym: PaSuT overallStatus: COMPLETED date: 2010-01-01 date: 2019-12-31 date: 2019-12-31 date: 2024-04-29 date: 2024-04-29 name: Richard Hunger class: OTHER name: Medizinische Hochschule Brandenburg Theodor Fontane briefSummary: The main objective of the study is to identify the optimal annual number of cases in a hospital with regard to minimising hospital mortality in pancreatic surgery. In particular, the prognostic value of such case numbers will be analysed. conditions: Volume-Outcome Relationship in Pancreatic Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 80000 type: ACTUAL name: Pancreatic resection procedure measure: In-hospital mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06389877 id: BTX-302-001 briefTitle: A Study to Evaluate the Safety and Efficacy of BEAM-302 in Adult Patients With Alpha-1 Antitrypsin Deficiency (AATD) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-06 date: 2027-08 date: 2024-04-29 date: 2024-04-29 name: Beam Therapeutics Inc. class: INDUSTRY briefSummary: This is a Phase 1/2, multicenter, open-label, dose-exploration (Phase 1) and dose-expansion (Phase 2) study to evaluate the safety, tolerability, PK/PD, and efficacy of BEAM-302 in adult patients with AATD-associated lung disease and/or liver disease and to determine the optimal biological dose (OBD). conditions: Alpha 1-Antitrypsin Deficiency studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 106 type: ESTIMATED name: BEAM-302 measure: Phase 1 Dose Exploration: Rates of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) measure: Phase 2 Dose Expansion: Absolute blood levels of total AAT measure: Phase 1 Dose Exploration: Absolute blood levels of total AAT measure: Phase 2 Dose Expansion: Rates of TEAEs and SAEs sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Study Center city: London country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
<\|newrecord\|> nctId: NCT06389864 id: rTMS in ADHD briefTitle: rTMS in Children and Adolescents With ADHD: overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-10 date: 2024-04-29 date: 2024-04-29 name: Assiut University class: OTHER briefSummary: Assess the effect of RTMS on ADHD symptoms and assessment of this effect clinically and objectively. conditions: ADHD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: rTMS (repetitive transcranial magnetic stimulation) measure: The resting motor threshold (RMT) measure: Arabic version Conners' Parent Rating Scale - Revised Long form measure: Clinical Global Impression CGI sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06389851 id: NAFLD-LYCOPENE briefTitle: Effects of Tomato Consumption on Steatosis, Intestinal Function and Glucose and Lipid Metabolism in Subjects With NAFLD overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2025-05-20 date: 2025-05-20 date: 2024-04-29 date: 2024-04-29 name: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis class: OTHER name: Dr. Di Stasi Vincenza name: Dr. Donvito Rosanna name: Dr. Cozzolongo Raffaele name: Dr. Giannuzzi Vito name: Dr. Zappimbulso Marianna name: Dr. Shahini Endrit name: Dr. Notarnicola Maria name: Dr. Russo Francesco name: Dr. Riezzo Giuseppe name: Dr. Donghia Rossella name: Dr. Cesternino Anna Maria name: Dr. Cici Rosalisa name: Dr. Cerabino Nicole name: Dr. Martina Di Chito name: Dr. Pesole Pasqua Letizia name: Dr. Coletta Sergio name: Dr. Stabile Dolores name: Dr. Ancona Anna name: Dr. D'Attoma Benedetta name: Dr. Ignazzi Antonia name: Dr. De Nunzio Valentina name: Dr. Tatoli Rossella name: Dr. Pinto Giuliano briefSummary: The study in question is an interventional study with nutritional intervention. the aim of the study is to evaluate whether a diet enriched with tomatoes can have favorable effects on:
* specific aspects associated with NAFLD, such as the degree of hepatic steatosis and fibrosis;
* circulating levels of molecules correlated with the degree of generalized and hepatic inflammation and the blood concentrations of metabolic and cardiovascular risk factors associated with abdominal obesity;
* intestinal barrier;
* body composition;
* intestinal microbiota;
* symptoms of IBS (irritable bowel syndrome) in patients with NAFLD. conditions: NAFLD conditions: IBS studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study evaluates the effects on NAFLD, Intestinal Integrity and Microbiota of a diet enriched with tomatoes compared to a diet without tomatoes primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Experimental: Case Group - Tomato-free diet name: Experimental: Case group - Diet enriched with tomatoes measure: The effect of intervention on CAP value (Controlled Attenuation Parameter) measure: The effect of intervention on FLI value (fatty liver index) measure: The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis measure: The effect of the intervention on the integrity of the intestinal barrier measure: The effect of the intervention on the microbiota sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Irccs Saverio de Bellis city: Castellana Grotte state: Bari zip: 70013 country: Italy lat: 40.88643 lon: 17.16549 hasResults: False
<\|newrecord\|> nctId: NCT06389838 id: DINKS01 id: DRKS00033704 type: REGISTRY domain: DRKS id: 2024-512094-27 type: EUDRACT_NUMBER briefTitle: RCT on Multimodal Self-treatment for Women With Incontinence Using a Digital Health Application acronym: DINKS overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2024-09-30 date: 2024-12-01 date: 2024-04-29 date: 2024-04-29 name: Kranus Health GmbH class: INDUSTRY name: Johannes Gutenberg University Mainz briefSummary: This study, titled "Prospective Randomized Study on Multimodal Self-Treatment for Women with Incontinence Symptoms Using a Digital Health Application," abbreviated as DINKS, aims to investigate the efficacy of a digital health application in treating incontinence in women. The study involves a single-center, single blinded, randomized, controlled trial with two arms: one receiving digital therapy intervention and the other serving as a control group with standard of care. The primary objective is to reduce the frequency of incontinence episodes over a 12-week intervention period, with secondary goals including improvements in disease symptoms, quality of life, and patient activation. The study plans to recruit 198 female participants and assess various endpoints related to incontinence severity, quality of life, and treatment outcomes. conditions: Urinary Incontinence,Stress conditions: Urinary Incontinence, Urge conditions: Urinary Incontinence conditions: Overactive Bladder Syndrome conditions: Female Urinary Stress Incontinence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomized, controlled, single-blinded, 2-arm design primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants know which group they are assigned to, but the investigators are blinded. whoMasked: INVESTIGATOR count: 198 type: ESTIMATED name: Kranus Mictera measure: Incontinence episodes measure: ICIQ-SF measure: I-QoL measure: PAM-13 measure: PGI-I measure: Cured patients measure: Urinary frequency day measure: Urinary frequency night measure: Pad use measure: Urge incontinence measure: Functional bladder capacity measure: Body weight measure: Treatment Failure sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kranus Health Gmbh city: München zip: 80331 country: Germany name: Laura E Wiemer, MD role: CONTACT phone: +4989 124 146 79 email: lwiemer@kranushelath.com lat: 48.13743 lon: 11.57549 hasResults: False
<\|newrecord\|> nctId: NCT06389825 id: FH-Diet-RX briefTitle: Unravelling the Impact of Diet on Cardiovascular Health in Treated Heterozygous Familial Hypercholesterolemia. overallStatus: RECRUITING date: 2024-04-01 date: 2024-06-30 date: 2024-06-30 date: 2024-04-29 date: 2024-04-29 name: Laval University class: OTHER briefSummary: The investigators will conduct a fully controlled dietary randomized crossover trial (RCT) including 10 adults with HeFH using lipid-lowering medication to investigate the impact of a diet low in red and processed meats and high in plant foods, reflecting Canada's Food Guide, in place of a standard North-American diet on LDL-cholesterol (LDL-C) levels and the plasma metabolome. conditions: Familial Hypercholesterolemia conditions: Nutrition, Healthy conditions: Cholesterol, Elevated studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 10 type: ESTIMATED name: Healthy diet measure: Post-diet differences in LDL-C levels. measure: Post-diet differences in plasma metabolomics profiles sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: INAF-NUTRISS Université Laval status: RECRUITING city: Québec zip: G1V0a6 country: Canada name: Valérie Guay role: CONTACT phone: 418-656-2131 email: valerie.guay@fsaa.ulaval.ca lat: 46.81228 lon: -71.21454 hasResults: False
<\|newrecord\|> nctId: NCT06389812 id: LoughboroughUni briefTitle: Dual-task Exercise in People With Cognitive Impairment overallStatus: ACTIVE_NOT_RECRUITING date: 2023-08-30 date: 2024-04-30 date: 2024-09-30 date: 2024-04-29 date: 2024-04-29 name: Loughborough University class: OTHER briefSummary: The purpose of this study is to explore how performing two exercise-based tasks simultaneously (dual-task exercise) affects the neurovascular and cognitive responses of people with cognitive impairment, which is a growing concern globally. Specifically, the study will examine how motor-cognitive dual-task exercises, such as using elastic resistance bands combined with visual perception training, including eye movement exercises, can immediately improve outcomes such as Brain-derived neurotrophic factor (BDNF) levels, cerebral blood flow, cognitive function, and mobility. BDNF is a special chemical in our brain that helps with the connections between brain cells. Participants will be asked to complete a single 30-minute exercise session and undergo assessments before and after the intervention. Participants with cognitive impairment will be initially assessed using Mini-Mental State Examination (MMSE) which is a 30-point questionnaire used extensively in clinical and research settings to measure cognitive impairment. Any score of 24 or more (out of 30) indicates normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points), or mild (19-23 points) cognitive impairment. Participants with lower MMSE scores (\<10) will be removed from the study. conditions: Dementia conditions: Mild Cognitive Impairment conditions: Older Adults studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Dual-task exercise traning measure: BDNF serum level measure: Visual screening sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Loughborough University city: Loughborough state: Leicestershire zip: LE11 3TU country: United Kingdom lat: 52.76667 lon: -1.2 hasResults: False
<\|newrecord\|> nctId: NCT06389799 id: PERELI id: 2022-501993-21-00 type: CTIS briefTitle: A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI) acronym: PERELI overallStatus: NOT_YET_RECRUITING date: 2024-05-07 date: 2027-12-31 date: 2028-12-31 date: 2024-04-29 date: 2024-04-29 name: Lund University Hospital class: OTHER briefSummary: Dedifferentiated liposarcomas (DDLPS) are aggressive soft tissue sarcomas with no effective medical treatment options.
Immunotherapy with checkpoint inhibitors, so-called PD-1 inhibitors, have shown some effect in DDLPS in previous studies. Effect of immunotherapy can be improved by combining it with other types of tumor drugs. Medicines that inhibit signaling via the FGF receptor, so-called FGFR inhibitors, have shown a tumor-slowing effect in DDLPS in early studies. FGFR inhibitors can also induce changes that make the tumor more available to treatment with immunotherapy.
The study aims to investigate whether the combination of an FGFR inhibitor, pemigatinib, with a PD-1 inhibitor, retifanlimab can provide a tumor-slowing effect in patients with advanced DDLPS who have progressed on first-line treatment. conditions: Dedifferentiated Liposarcoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: Pemigatinib name: Retifanlimab measure: To evaluate clinical benefit of retifanlimab and pemigatinib in patients with advanced DDLPS measure: To further evaluate clinical efficacy of retifanlimab and pemigatinib in DDLPS measure: To evaluate the safety and tolerability of pemigatinib and retifanlimab measure: To evaluate impact of treatment and disease status on quality of life measure: To evaluate the relationship between baseline and on-treatment biomarkers and clinical activity sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oslo University Hospital HF city: Oslo country: Norway name: Kjetil Boye, MD role: CONTACT phone: 4722934000 email: kjetil.boye@rr-research.no lat: 59.91273 lon: 10.74609 facility: Sahlgrenska University Hospital city: Göteborg country: Sweden name: Lina Hansson, MD role: CONTACT phone: 46313427950 email: lina.hansson@vgregion.se lat: 57.70716 lon: 11.96679 facility: Lund University Hospital city: Lund country: Sweden name: Helena Nyström, MD role: CONTACT role: CONTACT phone: +4646177520 email: helena.nystrom@skane.se lat: 55.70584 lon: 13.19321 hasResults: False
<\|newrecord\|> nctId: NCT06389786 id: MC230504 id: NCI-2024-03306 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-009377 type: OTHER domain: Mayo Clinic Institutional Review Board id: MC230504 type: OTHER domain: Mayo Clinic briefTitle: Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2026-05 date: 2026-05 date: 2024-04-29 date: 2024-04-29 name: Mayo Clinic class: OTHER briefSummary: This clinical trial evaluates the use of an imaging scan (18F-rhPSMA-7.3 positron emission tomography \[PET\]/magnetic resonance imaging \[MRI\]) for identifying patients who are at risk of having their disease spread to the lymph nodes in those undergoing radical prostatectomy for prostate cancer that has not spread to other parts of the body (localized). Prostate specific membrane antigen (PSMA) PET/computed tomography (CT) has emerged as an option to stage newly diagnosed high risk prostate cancer patients. PSMA PET/CT has demonstrated improved diagnostic accuracy for identifying metastasis. PET is procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is used. Because cancer cells often use more glucose than normal cells, the pictures can be used to find cancer cells in the body. MRI is procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. This study may help researchers learn whether 18F-rhPSMA-7.3 PET/ MRI may improve predicting which patients are at risk of lymph node metastases and who are suitable candidates for pelvic lymph node dissection in patients with localized high-risk prostate cancer undergoing radical prostatectomy. conditions: Localized Prostate Carcinoma conditions: Oligometastatic Prostate Carcinoma conditions: Stage I Prostate Cancer AJCC v8 conditions: Stage II Prostate Cancer AJCC v8 conditions: Stage III Prostate Cancer AJCC v8 conditions: Stage IVA Prostate Cancer AJCC v8 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 50 type: ESTIMATED name: Bilateral Pelvic Lymph Node Dissection name: Biospecimen Collection name: Bone Scan name: Computed Tomography name: Electronic Health Record Review name: Flotufolastat F-18 Gallium name: Laparoscopic Radical Prostatectomy with Robotics name: Magnetic Resonance Imaging name: Positron Emission Tomography measure: Sensitivity of flotufolastat F-18 gallium (18F-rhPSMA-7.3) positron emission tomography (PET)/magnetic resonance (MRI) for the detection of lymph node metastasis measure: Specificity measure: Positive/negative predictive value measure: Prostate specific antigen (PSA): < 5, 5-10, 10-20, > 20 measure: Gleason score measure: Digital rectal examination measure: Number of patients where management has changed measure: Rates of biochemical recurrent disease (BCR) sex: MALE minimumAge: 30 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Florida city: Jacksonville state: Florida zip: 32224-9980 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Ram A. Pathak, M.D. role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 hasResults: False
<\|newrecord\|> nctId: NCT06389773 id: 302958 briefTitle: Teamwork for Resilient Staff and Safe Care in ICU acronym: FEARLESS_ICU overallStatus: NOT_YET_RECRUITING date: 2024-09-02 date: 2025-09-30 date: 2025-09-30 date: 2024-04-29 date: 2024-04-29 name: King's College London class: OTHER briefSummary: The goal of this ethnographic study is to observe how healthcare professionals work together in an intensive care unit (ICU). The main questions it aims to answer are
* How do healthcare staff work together in everyday ICU settings?
* What helps people work together in ICUs?
* What challenges do staff face in working together in ICUs?
* How have teamwork practices changed since the COVID-19 pandemic?
Researchers will shadow staff during their day-to-day work. Key staff members will also be interviewed about their perceptions and experiences of teamwork. conditions: Teamwork studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 75 type: ESTIMATED measure: Examine the changing nature of teamwork in ICUs in the post-pandemic context sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06389760 id: IST-Nim-PC-16 briefTitle: Single-arm Study of Nimotuzumab Combined With mFOLFIRNIOX as Postoperative Adjuvant Therapy in Pancreatic Cancer overallStatus: RECRUITING date: 2023-10-18 date: 2026-09-30 date: 2026-09-30 date: 2024-04-29 date: 2024-04-29 name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School class: OTHER briefSummary: This is a prospective, multicenter, single-arm, phase II trial. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with mFOLFIRINOX for postoperative adjuvant treatment of pancreatic cancer. conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Nimotuzumab name: mFOLFIRINOX measure: disease-free survival (DFS) measure: distant metastasis-free survival (DMFS) measure: overall survival (OS) measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire pancreatic cancer 29 (EORTC-QLQ-PAN26) measure: tumor-related markers measure: adverse events sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School status: RECRUITING city: Nanjing state: Jiangsu zip: 210008 country: China name: Juan Du, M.D. Ph.D role: CONTACT phone: +86-025-83106666 email: dujunglyy@163.com name: Juan Du, M.D. Ph.D role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06389747 id: OU briefTitle: Effect of Blood Flow Restriction Technique on Delayed Onset Muscle Soreness overallStatus: RECRUITING date: 2024-04-24 date: 2024-05-28 date: 2024-06-15 date: 2024-04-29 date: 2024-04-29 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: The aim of our study is to determine and evaluate the effects of blood flow restriction technique on pain, biomechanical properties and strength of the muscle in delayed onset muscle pain in healthy individuals. A Double Blind, Randomized Controlled, prospective study was planned. conditions: Pain Intensity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: participants and assessors will be blind to different intensity BFR groups. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 15 type: ESTIMATED name: BFR technique measure: Visual analog scale measure: myoton measure: dynamometer measure: dolorimeter sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Gamze Aydın status: RECRUITING city: Istanbul zip: 34940 country: Turkey name: Gamze Aydın role: CONTACT email: gmzetsn@gmail.com lat: 41.01384 lon: 28.94966 facility: Istanbul Okan University status: RECRUITING city: Istanbul zip: 34944 country: Turkey name: Gamze Aydın, PhD role: CONTACT phone: +905377600256 email: gmzetsn@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06389734 id: B-ER-111-470 briefTitle: Combining Manual Soft Tissue Release and Exercise Training in COPD: the Effect on LF, EC, and CAF overallStatus: COMPLETED date: 2023-03-02 date: 2024-02-02 date: 2024-02-02 date: 2024-04-29 date: 2024-04-29 name: National Cheng Kung University class: OTHER briefSummary: The potential effects of combining manual soft tissue release and physical exercise training on lung function, exercise capacity, and cardiac autonomic function in patients with moderate and severe chronic obstructive pulmonary disease were investigated. conditions: Chronic Obstructive Pulmonary Disease conditions: Manual Soft Tissue Release conditions: Exercise Training conditions: Lung Function conditions: Exercise Capacity conditions: Cardiac Autonomic Function studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study population will be randomized and separated in two groups, experimental and control group. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 70 type: ACTUAL name: Manual soft tissue release name: Myofascial release name: Exercise training measure: Forced expiratory volume in 1 s (FEV1) measure: forced vital capacity (FVC) measure: FEV1/FVC ratio measure: expiratory reserve volume (ERV) measure: functional residual capacity (FRC) measure: inspiratory capacity (IC) measure: inspiratory reserve volume (IRV), measure: residual volume (RV) measure: total lung capacity (TLC) measure: tidal volume (TV) measure: vital capacity (VC) measure: Rate of perceived exertion (RPE) measure: Oxygen consumption (VO2) measure: oxygen saturation measure: heart rate (HR) measure: blood pressure (BP) measure: Diaphragmatic mobility measure: Cardiac Autonomic Function measure: six minute walk test (6-MWT) measure: maximal expiratory pressure (MEP) measure: maximal inspiratory pressure (MIP) measure: St. George's Respiratory Questionnaire (SGRQ) measure: fatigue severity scale (FSS) measure: Modified Medical Research Council (mMRC) measure: 36-Item Short Form Health Survey (SF-36) sex: ALL minimumAge: 30 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cheng Kung University city: Tainan zip: 701 country: Taiwan lat: 22.99083 lon: 120.21333 hasResults: False
<\|newrecord\|> nctId: NCT06389721 id: 2024-0145 id: NCI-2024-03672 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2025-01-31 date: 2027-01-31 date: 2024-04-29 date: 2024-04-29 name: M.D. Anderson Cancer Center class: OTHER briefSummary: Cohort 1: To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy (CIPN).
Cohort 2: To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy (CIPN) and to test a certain type of experimental neuromodulation (stimulation of the brain) with a device called a closed-loop brain-computer interface (clBCI) to see if can help to prevent pain due to CIPN. conditions: Chemotherapy-induced Peripheral Neuropathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 45 type: ESTIMATED name: Electroencephalogram (EEG) measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Sarah Prinsloo, PHD role: CONTACT phone: 713-563-9627 email: sprinsloo@mdanderson.org name: Sarah Prinsloo, PHD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
<\|newrecord\|> nctId: NCT06389708 id: VEVUS-HF briefTitle: Evaluation of VEXUS Score of Patients With Heart Failure in the Intensive Care Unit. overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-12-15 date: 2025-01-15 date: 2024-04-29 date: 2024-04-29 name: Inonu University class: OTHER briefSummary: Heart failure is a syndrome that progresses with symptoms and signs caused by cardiac dysfunction and results in a shortened life expectancy (1). Acute heart failure resulting in hospitalization is a significant cause of morbidity and mortality. With the increase in the severity of the disease and rapid advances in the treatment of heart failure, these patients are frequently hospitalized and monitored in intensive care. (2) Five years after diagnosis, mortality can be up to 67%. Additionally, it is known that patients with heart failure are hospitalized on average once a year after diagnosis. (3) In a multicenter study, it constituted 14% of 3000 cardiac patients admitted to intensive care units. Additionally, due to longer ICU stays, these patients accounted for 33% of total inpatient days. An increasing number of heart failure patients require intensive care due to respiratory failure, regardless of left ventricular ejection fraction. Heart failure accounts for approximately one-third of patient days in intensive care units, and this burden is increasing. This shows that attention should be paid to the quality of care for patients requiring critical care. (2) Multidisciplinary programs have been implemented to deal with the high prevalence. However, the optimal follow-up frequency is unknown. Therefore, some tools are needed to improve patient prognosis (3). Neutrophil gelatinase-associated lipocalin (NGAL) is a biomarker whose values in both urine and plasma have been associated with acute kidney injury (AKI). Although NGAL is an early specific biomarker for AKI, it has not yet come into routine use, but is frequently used in clinical and experimental studies (4). Venous load ultrasonography score (VExUS) is a new systemic congestion scoring method based on inferior vena cava dilation and pulsed wave Doppler (PW-Doppler) morphology of the hepatic, portal and renal veins. It has been proposed as a score to assess systemic congestion. conditions: Heart Failure conditions: Acute Kidney Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: VEXUS measure: MORTALİTY measure: AKI sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06389695 id: CP-2023-03 id: NYM032D01 type: OTHER domain: National Medical Products Administration briefTitle: Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM032 in Patients overallStatus: RECRUITING date: 2024-05 date: 2024-12 date: 2024-12 date: 2024-04-29 date: 2024-04-29 name: Norroy Bioscience Co., LTD class: INDUSTRY briefSummary: 68Ga-NYM032 is a PSMA-targeting small-molecular radiotracer for PET/CT imaging of prostate cancer, which is needed for clinical trial to be conducted conditions: Prostate Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 10 type: ESTIMATED name: 68Ga-NYM032 injection measure: Incidence of Adverse Events sex: MALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affliated Hospital of Jiangnan University status: RECRUITING city: Wuxi state: Jiangsu zip: 214000 country: China name: Chunjing Yu role: CONTACT phone: 15312238622 email: ycj_wxd1978@163.com lat: 31.56887 lon: 120.28857 hasResults: False
<\|newrecord\|> nctId: NCT06389682 id: CP-2023-02 briefTitle: Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM005 in Patients overallStatus: RECRUITING date: 2024-05 date: 2024-12 date: 2024-12 date: 2024-04-29 date: 2024-04-29 name: Norroy Bioscience Co., LTD class: INDUSTRY briefSummary: 68Ga-NYM005 is a CAIX-targeting small-molecular radiotracer for PET/CT imaging of clear cell renal cell carcinoma conditions: Clear Cell Renal Cell Carcinoma Metastatic studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 12 type: ESTIMATED name: 68Ga-NYM005 injection measure: Incidence of Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affliated Hospital of Jiangnan University status: RECRUITING city: Wuxi state: Jiangsu zip: 214000 country: China name: Chunjing Yu role: CONTACT phone: 15312238622 email: ycj_wxd1978@163.com lat: 31.56887 lon: 120.28857 hasResults: False
<\|newrecord\|> nctId: NCT06389669 id: Inonu LTI briefTitle: Is Low Flow Anaesthesia Feasible? overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-08-15 date: 2024-09-15 date: 2024-04-29 date: 2024-04-29 name: Inonu University class: OTHER briefSummary: Although low-flow anaesthesia (LFA) has been described for many years and its benefits are known, its clinical use has been limited. Concerns about the risk of hypoxia contributed to this situation. Although the risk of hypoxia is almost prevented with advanced anaesthesia machines, the use of LFA has not reached the desired levels. However, in recent years, as adverse developments related to climate change have started to affect us all, LFA has started to be on the agenda of anaesthetists again. In this study, our aim is to examine the feasibility of its clinical use in order to popularise the use of LFA. conditions: Feasibility of Low Flow Anaesthesia in Clinical Use conditions: Factors Affecting Oxygen Consumption studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED measure: Feasibility of Low Flow Anaesthesia measure: Factors affecting oxygen consumption sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inonu Univercity city: Malatya zip: 44280 country: Turkey lat: 38.35018 lon: 38.31667 hasResults: False
<\|newrecord\|> nctId: NCT06389656 id: 1K23DK135791-01 type: NIH link: https://reporter.nih.gov/quickSearch/1K23DK135791-01 briefTitle: Addressing Weight Bias Internalization to Improve Adolescent Weight Management Outcomes acronym: SWIFT overallStatus: RECRUITING date: 2024-04-08 date: 2025-02 date: 2025-02 date: 2024-04-29 date: 2024-04-29 name: The Miriam Hospital class: OTHER briefSummary: Weight stigma and weight bias internalization (WBI) are common among adolescents at higher weight statuses. WBI is associated with negative physical and mental health outcomes. The current study aims to test intervention for weight stigma and WBI in conjunction with an evidence-based adolescent weight management program. Adolescents (ages 13-17) will participate in a 20-week program tailored to improve WBI and weight-related health behaviors in tandem. Primary outcomes are feasibility and acceptability of the developed intervention, assessed following the 20-week intervention. conditions: Body Weight conditions: Weight Bias conditions: Weight Stigma conditions: Weight studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open trial primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Behavioral Weight Management name: Weight Bias Internalization measure: Total score on an adapted version of the Acceptability of Intervention Measure (AIM) measure: In depth qualitative feedback from teens regarding intervention acceptability and feasibility measure: Attendance rates at intervention sessions measure: Retention rate for intervention sessions measure: Total score on the Modified Weight Bias Internalization Scale (WBIS-M) measure: Total score on the Weight Self-Stigma Questionnaire (WSSQ) measure: Total score on the weight-related teasing sub-scale of the Perception of Teasing Scale (POTS) measure: Total score on the competency-related teasing subscale of the Perception of Teasing Scale (POTS) measure: Anthropometrics sex: ALL minimumAge: 13 Years maximumAge: 17 Years stdAges: CHILD facility: The Miriam Hospital status: RECRUITING city: Providence state: Rhode Island zip: 02903 country: United States name: Katherine Darling, PhD role: CONTACT phone: 401-793-8688 email: katherine_darling@brown.edu name: Andrea M Grenga, BA role: CONTACT phone: 401-793-8997 email: agrenga@lifespan.org lat: 41.82399 lon: -71.41283 hasResults: False
<\|newrecord\|> nctId: NCT06389643 id: 11/WIM/2021 briefTitle: Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and Yamane Techniques overallStatus: COMPLETED date: 2021-03-19 date: 2022-09-14 date: 2023-09-19 date: 2024-04-29 date: 2024-04-29 name: Military Institute od Medicine National Research Institute class: OTHER briefSummary: Comparison of safety and efficacy of two scleral fixation intraocular lens (IOL) methods of four-point scleral fixation ( Akreos AO60) and the Yamane technique (AcrySof MA60AC) conditions: Aphakia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 50 type: ACTUAL name: Four-point scleral fixation of Akreos AO60 IOL name: Sutureless scleral fixation of AcrySof MA60AC IOL with Yamane technique measure: BCVA measure: RE measure: ECC measure: Number of complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Military Institute of Medicine - National Research Institute city: Warsaw zip: 04-141 country: Poland lat: 52.22977 lon: 21.01178 hasResults: False
<\|newrecord\|> nctId: NCT06389630 id: 0012 briefTitle: Evaluation of the Efficiency of Two Different Teaching Methods in Safe Subcutaneous Injection Skills acronym: EETDTMSSİS overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2024-11-20 date: 2025-01-20 date: 2024-04-29 date: 2024-04-29 name: Kocaeli Sağlık ve Teknoloji Üniversitesi class: OTHER briefSummary: Subject: Subcutaneous (SC) insulin injection is frequently used in the treatment of Type 2 Diabetes patients. Complications such as pain, ecchymosis, hematoma, lipoatrophy and lipohypertrophy are frequently observed after SC injections. These complications that develop due to incorrect injection application negatively affect the use of injection application areas, change body image and negatively affect drug absorption. In order to reduce and prevent complications related to SC insulin injection, it is very important to gain the skill of safe SC insulin injection. It is stated that there are a limited number of studies on which of the teaching methods used in sick individuals are effective. In the national and international literature, no study has been found evaluating the effect of SC injection skill teaching based on video-supported training and low-fidelity simulation model applications on disease management in individuals diagnosed with Type 2 Diabetes Mellitus. In this regard, the research was planned as an experimental design in order to examine the effectiveness of video-supported training and low-fidelity simulation model-based teaching in gaining safe insulin injection skills via SC. For this purpose; It is aimed to evaluate the effect of two different skill teaching methods on the patient's SC injection ability, complication management and blood glucose level.
Purpose: This research was planned as an experimental design to examine the effectiveness of two different teaching methods (video-supported training and low-fidelity simulation model) in gaining safe insulin injection skills via the Subcutaneous (SC) route.
Design: A pretest-posttest two-group, quasi-experimental design will be used in the study. conditions: Complication of Injection studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 82 type: ESTIMATED name: video-assisted training group name: low fidelity simulation model group measure: subcutaneous injection skills measure: ecchymosis measure: hematoma measure: lipoarthrrophy measure: lipohypertrophy measure: pain measure: blood glucose level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06389617 id: USM/JEPeM/KK/24010061 briefTitle: Different Doses of Intravenous Administered Dexamethasone Effecting Brachial Plexus Supraclavicular Block overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-11-30 date: 2024-12-30 date: 2024-04-29 date: 2024-04-29 name: Hospital Universiti Sains Malaysia class: OTHER briefSummary: To compare the analgesic properties of ultrasound guided supraclavicular block using ropivacaine 0.5% in arteriovenous fistula creation when used in combination with intravenous administered dexamethasone at 4mg and 8 mg as an adjuvant conditions: End Stage Renal Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 50 type: ESTIMATED name: supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous administered dexamethasone measure: To compare the difference of onset time between sensory and motor block of supraclavicular block between ropivacaine with IV dexamethasone 4mg and ropivacaine with IV dexamethasone 8mg measure: To compare the difference in duration of analgesia between supraclavicular block with ropivacaine and IV dexamethasone 4mg with ropivacaine and IV dexamethasone 8mg measure: To compare the duration difference of the return of motor block between supraclavicular block using ropivacaine with IV dexamethasone 4mg and ropivacaine with IV dexamethasone 8mg sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06389604 id: NL86367.068.24 briefTitle: Preparing for Heat Waves - Enhancing Human Thermophysiological Resilience acronym: Prep4heat overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2024-12 date: 2024-04-29 date: 2024-04-29 name: Maastricht University Medical Center class: OTHER briefSummary: As the ongoing progression of climate change exposes individuals to elevated temperatures and an escalating frequency of extreme heat events, the risk of more intense and prolonged heat waves raises significant concerns for public health, particularly among vulnerable populations. The physiological response to acute heat stress involves involuntary thermolytic reactions that may strain the cardiovascular system, especially in individuals with pre-existing vulnerabilities. Heat acclimation has been identified as a potential strategy to enhance thermoregulation and mitigate the adverse effects of heat stress. While existing research primarily focuses on athletes and military, this study aims to investigate the impact of a practical heat acclimation strategy, combining passive and active heat exposure, on thermophysiological, cardiovascular and metabolic parameters in healthy overweight adults. The study targets a population at increased risk for heat-related complications, seeking to provide realistic guidelines for broader application when a heat wave appears on the weather forecast. conditions: Body Temperature Changes conditions: Heat Exposure conditions: Heat Stress conditions: Hyperthermia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Non-randomized, within subject experiemental trial primaryPurpose: PREVENTION masking: NONE maskingDescription: No blinding due to nature of intervention count: 12 type: ESTIMATED name: Heat acclimation measure: Core temperature measure: Skin temperature measure: Sweat rate measure: Heart rate measure: Blood pressure measure: Skin blood flow measure: Energy expenditure measure: Substrate oxidation measure: Plasma metabolites measure: Brain blood flow measure: Flow-mediated dilation sex: ALL minimumAge: 60 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06389591 id: OCR44973 briefTitle: RNA-Lipid Particle (RNA-LP) Vaccines for Recurrent Adult Glioblastoma (GBM) overallStatus: NOT_YET_RECRUITING date: 2024-12 date: 2027-12 date: 2028-12 date: 2024-04-29 date: 2024-04-29 name: University of Florida class: OTHER briefSummary: This is a Phase I study to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in adult patients with recurrent glioblastoma. conditions: Recurrent Glioblastoma studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: pp65 RNA loaded lipid particles, pp65 RNA-LPs (Drug Product 1 or DP1) name: RNA loaded lipid particles, RNA-LPs (Drug Product 2 or DP2) measure: Percentage of vaccines meeting release criteria in the DLT window during the first three vaccines measure: Incidence of investigational treatment related toxicities sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UF Health city: Gainesville state: Florida zip: 32608 country: United States name: Marcia Hodik role: CONTACT phone: 352-273-9000 email: marcia.hodik@neurosurgery.ufl.edu name: Ashley Ghiaseddin, MD role: PRINCIPAL_INVESTIGATOR lat: 29.65163 lon: -82.32483 hasResults: False
<\|newrecord\|> nctId: NCT06389578 id: HZNP-TEP-103 briefTitle: A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease overallStatus: COMPLETED date: 2022-07-14 date: 2023-02-28 date: 2023-09-12 date: 2024-04-29 date: 2024-04-29 name: Horizon Therapeutics USA, Inc. class: INDUSTRY briefSummary: The main goal of this study is to learn how teprotumumab will be processed in the body (Pharmacokinetics) subcutaneously and whether it is safe and tolerable after administration into adult patients with thyroid eye disease. conditions: Thyroid Eye Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 16 type: ACTUAL name: Teprotumumab measure: Pharmacokinetics (PK): Area Under the Curve (AUC) of Teprotumumab measure: PK: Maximum Serum Concentration (Cmax) of Teprotumumab measure: Number of Participants With Adverse Events (AE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bascom Palmer Eye Institute - University of Miami city: Miami state: Florida zip: 33136 country: United States lat: 25.77427 lon: -80.19366 facility: Barnes Jewish Hospital Washington University city: Saint Louis state: Missouri zip: 63108 country: United States lat: 38.62727 lon: -90.19789 facility: Neuro-Eye Clinical Trials city: Bellaire state: Texas zip: 77401 country: United States lat: 29.70579 lon: -95.45883 hasResults: False
<\|newrecord\|> nctId: NCT06389565 id: 2024p000857 briefTitle: Pilot Randomized Clinical Trial of Change My Story overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2025-12-31 date: 2026-06-30 date: 2024-04-29 date: 2024-04-29 name: Massachusetts General Hospital class: OTHER name: University of Ibadan briefSummary: Psychological distress and depression are common among young people living with HIV (Y-PLWH) and negatively impact medication adherence and disease control. In low- and middle-income countries, this problem is compounded by the lack of trained mental health professionals on the provider side and the requirement of frequent clinic-based visits imposing greater cost, inconvenience, and stigma for patients. Change My Story, is a theory-grounded, interactive narrative game designed to address the key drivers of depression and psychological distress among Y-PLWH in Nigeria. This pilot hybrid implementation-effectiveness randomized controlled trial (RCT) will compare Change My Story combined with PST to PST alone among 80 Y-PLWH with depression or psychological distress. conditions: Hiv conditions: Depression conditions: Psychological Distress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Problem Solving Therapy name: Change My Story measure: Engagement measure: Satisfaction measure: Feasibility 1 measure: Feasibility 2 measure: Feasibility 3 measure: Feasibility 4 measure: Feasibility 5 measure: Feasibility 6 measure: Feasibility 7 measure: Acceptability 1 measure: Acceptability 2 measure: Acceptability 3 measure: Acceptability 4 measure: Acceptability 5 measure: Remission of depression. measure: Remission of psychological distress. measure: ART adherence measure: Viral suppression sex: ALL minimumAge: 16 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06389552 id: IN_CTP_N01 briefTitle: Long-term Observational Study to Evaluate the DFS and OS of Adjuvant FOLFIRINOX Regimen in Pancreatic Cancer Patients overallStatus: RECRUITING date: 2023-09-25 date: 2026-12 date: 2027-12 date: 2024-04-29 date: 2024-04-29 name: HK inno.N Corporation class: INDUSTRY briefSummary: This study is designed to evaluate the safety and efficacy of adjuvant FOLFIRINOX regimen in pancreatic cancer patients after curative surgery. conditions: Adjuvant Chemotherapy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 36 type: ESTIMATED measure: Disease-free survival measure: Overall survival sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul ST. Mary's Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Myung-Ah Lee role: CONTACT name: Myung-Ah Lee role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False
<\|newrecord\|> nctId: NCT06389539 id: Pro00070958 briefTitle: Synbiotic to Attenuate Resorption of the Skeleton acronym: STARS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-04 date: 2028-04 date: 2024-04-29 date: 2024-04-29 name: Hebrew SeniorLife class: OTHER name: Solarea Bio, Inc name: Beth Israel Deaconess Medical Center name: Tufts University name: MaineHealth briefSummary: This randomized, double blind, placebo controlled clinical trial will test the efficacy of a probiotic/prebiotic combination ("synbiotic") on the skeleton in older women. conditions: Osteoporosis conditions: Inflammation conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to either SBD111 medical food or placebo capsules for a period of 18 months. primaryPurpose: OTHER masking: QUADRUPLE maskingDescription: Study staff involved in participants' outcome assessments will be masked to the intervention assignment. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 220 type: ESTIMATED name: SBD111 medical food name: Placebo measure: Lumbar spine BMD (g/cm2) measure: Vertebral compressive strength (N) measure: volumetric BMD measure: C-terminal cross-linked telopeptide of type I collagen (β-CTX) measure: Procollagen Type I Intact N-terminal Propeptide (P1NP) sex: FEMALE minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hebrew SeniorLife city: Roslindale state: Massachusetts zip: 02131 country: United States name: Kathryn Tasker role: CONTACT phone: 617-971-5351 email: KathyTasker@hsl.harvard.edu lat: 42.29121 lon: -71.1245 hasResults: False
<\|newrecord\|> nctId: NCT06389526 id: CHS-1000-01 briefTitle: A Study of CHS-1000 in Participants With Advanced or Metastatic Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2028-01-30 date: 2028-01-30 date: 2024-04-29 date: 2024-04-29 name: Coherus Biosciences, Inc. class: INDUSTRY briefSummary: The primary purpose of this trial is to assess the tolerability and safety of CHS-1000 alone and in combination with toripalimab-tpzi in participants with advanced solid tumors. conditions: Advanced or Metastatic Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: CHS-1000 name: Toripalimab measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) measure: Maximum Observed Concentration (Cmax) measure: Area Under the Concentration-time Curve (AUC) measure: Terminal Half-life (t1/2) measure: Number of Participants with Antidrug Antibodies measure: Investigator-assessed Objective Response Rate (ORR) measure: Duration of Response (DoR) measure: Disease Control Rate (DCR) measure: Time to Response (TTP) measure: Progression-free Survival (PFS) measure: Landmark PFS Rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06389513 id: CTP-MCVF-005 briefTitle: Clinical Study of the Safety of Menhycia® in 3-Month-Old Infants overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-04 date: 2025-04 date: 2024-04-29 date: 2024-04-29 name: CanSino Biologics Inc. class: INDUSTRY briefSummary: This study is an open, multicenter Phase IV clinical study to evaluate the safety of vaccination with Menhycia®. The study plan is to enroll approximately 3,000 infants at 3 months of age who have not been vaccinated with any epidemic encephalitis vaccine, and to administer a total of 3 doses of Menhycia®, with a minimum of 1 month between doses, and a booster dose of 1 dose of immunization is allowed at 12 months of age. conditions: Epidemic Meningitis studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 3000 type: ESTIMATED name: MCV4 measure: Incidence of localized adverse reactions in subjects measure: Incidence of systemic adverse reactions in subjects measure: Incidence of adverse reactions in subjects measure: Incidence of adverse events in subjects measure: Incidence of severe adverse events sex: ALL minimumAge: 3 Months maximumAge: 3 Months stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06389500 id: SHR-1316-HLJ-006 briefTitle: HAIC+Adebrelimab+Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2028-05-01 date: 2024-04-29 date: 2024-04-29 name: Harbin Medical University class: OTHER briefSummary: This is a single-arm, exploratory, phase II trial to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib for borderline resectable, locally advanced biliary tract cancer. conditions: Biliary Tract Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Adebrelimab name: Lenvatinib name: Hepatic Arterial Infusion Chemotherapy measure: R0 resection rate measure: Surgery conversion rate measure: Objective response rate measure: pathological complete response rate measure: Major pathological response rate measure: Recurrence-free survival measure: Overall survival measure: AEs sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06389487 id: 222253 id: 2023-510190-34-00 type: OTHER domain: EU CTR Number briefTitle: A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2024-08-12 date: 2025-04-28 date: 2024-04-29 date: 2024-04-29 name: GlaxoSmithKline class: INDUSTRY briefSummary: The aim of this study is to demonstrate the immune response and to evaluate safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for respiratory syncytial virus (RSV) disease, compared to older adults (OA) (\>=) 60 YOA and above conditions: Respiratory Syncytial Virus Infections studyType: INTERVENTIONAL phases: PHASE3 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 850 type: ESTIMATED name: RSVPreF3 OA investigational vaccine measure: RSV-A neutralizing titers expressed as Geometric Mean Titers (GMTs) ratio (RSV-OA over RSV-A-AIR) measure: Seroresponse rate (SRR) in RSV-A neutralizing titers measure: RSV-B neutralizing titers expressed as GMT ratio (RSV-OA over RSV-A-AIR) measure: SRR in RSV-B neutralizing titers measure: Percentage of participants reporting solicited administration site events measure: Percentage of participants reporting solicited systemic events measure: Percentage of participants reporting unsolicited adverse events (AEs) measure: Percentage of participants reporting any serious adverse events (SAEs), related SAEs and fatal SAEs measure: Percentage of participants reporting any adverse events of special interest (AESIs), including potential immune-mediated diseases (pIMDs) and atrial fibrillation (AF) measure: RSV-A neutralizing titers expressed as GMTs measure: RSV-B neutralizing titers expressed as GMTs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GSK Investigational Site city: Phoenix state: Arizona zip: 85023 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Abram Burgher role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: GSK Investigational Site city: Tempe state: Arizona zip: 85284 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Joseph Daniel Davis role: PRINCIPAL_INVESTIGATOR lat: 33.41477 lon: -111.90931 facility: GSK Investigational Site city: North Hollywood state: California zip: 91606-3287 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Aaron Weinberg role: PRINCIPAL_INVESTIGATOR lat: 34.17223 lon: -118.37897 facility: GSK Investigational Site city: Oakland state: California zip: 94610 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Allison Boyd role: PRINCIPAL_INVESTIGATOR lat: 37.80437 lon: -122.2708 facility: GSK Investigational Site city: Walnut Creek state: California zip: 94598 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Helen L Stacey role: PRINCIPAL_INVESTIGATOR lat: 37.90631 lon: -122.06496 facility: GSK Investigational Site city: Hialeah state: Florida zip: 33012 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jose Cardona role: PRINCIPAL_INVESTIGATOR lat: 25.8576 lon: -80.27811 facility: GSK Investigational Site city: Miami state: Florida zip: 33173 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jorge Caso role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: GSK Investigational Site city: Orlando state: Florida zip: 32806 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Felipe Suplicy role: PRINCIPAL_INVESTIGATOR lat: 28.53834 lon: -81.37924 facility: GSK Investigational Site city: Lexington state: Kentucky zip: 40509 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Mark S Adams role: PRINCIPAL_INVESTIGATOR lat: 37.98869 lon: -84.47772 facility: GSK Investigational Site city: Silver Spring state: Maryland zip: 20904 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jonathan Cohen role: PRINCIPAL_INVESTIGATOR lat: 38.99067 lon: -77.02609 facility: GSK Investigational Site city: Rochester state: New York zip: 14609 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Matthew G Davis role: PRINCIPAL_INVESTIGATOR lat: 43.15478 lon: -77.61556 facility: GSK Investigational Site city: Oklahoma City state: Oklahoma zip: 73111 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Charles Lunn role: PRINCIPAL_INVESTIGATOR lat: 35.46756 lon: -97.51643 facility: GSK Investigational Site city: Knoxville state: Tennessee zip: 37909 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: William Smith role: PRINCIPAL_INVESTIGATOR lat: 35.96064 lon: -83.92074 facility: GSK Investigational Site city: DeSoto state: Texas zip: 75115 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Haresh Boghara role: PRINCIPAL_INVESTIGATOR lat: 32.58986 lon: -96.85695 facility: GSK Investigational Site city: Charlottesville state: Virginia zip: 22911 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: James R Clark role: PRINCIPAL_INVESTIGATOR lat: 38.02931 lon: -78.47668 facility: GSK Investigational Site city: Wenatchee state: Washington zip: 98801 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Anton Grasch role: PRINCIPAL_INVESTIGATOR lat: 47.42346 lon: -120.31035 facility: GSK Investigational Site city: St Leonards state: New South Wales zip: 2065 country: Australia name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Munro Neville role: PRINCIPAL_INVESTIGATOR lat: -33.82344 lon: 151.19836 facility: GSK Investigational Site city: Tarragindi state: Queensland zip: 4121 country: Australia name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Ferdinandus de Looze role: PRINCIPAL_INVESTIGATOR lat: -27.53333 lon: 153.03333 facility: GSK Investigational Site city: North Melbourne state: Victoria zip: 3051 country: Australia name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Michelle Giles role: PRINCIPAL_INVESTIGATOR lat: -37.80132 lon: 144.95822 facility: GSK Investigational Site city: St Albans state: Victoria zip: 3021 country: Australia name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Roy Rasalam role: PRINCIPAL_INVESTIGATOR lat: -37.73901 lon: 144.80024 facility: GSK Investigational Site city: New Westminster state: British Columbia zip: V3L 3W4 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: David Shu role: PRINCIPAL_INVESTIGATOR lat: 49.20678 lon: -122.91092 facility: GSK Investigational Site city: Victoria state: British Columbia zip: V8V 4A1 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Michael B Jones role: PRINCIPAL_INVESTIGATOR lat: 48.43294 lon: -123.3693 facility: GSK Investigational Site city: Truro state: Nova Scotia zip: B2N 1L2 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Murdo Ferguson role: PRINCIPAL_INVESTIGATOR lat: 45.36685 lon: -63.26538 facility: GSK Investigational Site city: Guelph state: Ontario zip: N1G 0B4 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Anthony Bier role: PRINCIPAL_INVESTIGATOR lat: 43.54594 lon: -80.25599 facility: GSK Investigational Site city: London state: Ontario zip: N5W 6A2 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Peter Dzongowski role: PRINCIPAL_INVESTIGATOR lat: 42.98339 lon: -81.23304 facility: GSK Investigational Site city: Sherbrooke state: Quebec zip: J1J 2G2 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jean-Sebastien Gauthier role: PRINCIPAL_INVESTIGATOR lat: 45.40008 lon: -71.89908 facility: GSK Investigational Site city: St-Charles-Borromée state: Quebec zip: J6E 2B4 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Bonavuth Pek role: PRINCIPAL_INVESTIGATOR lat: 46.05007 lon: -73.46586 facility: GSK Investigational Site city: Quebec zip: G1N 4V3 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jean-Francois Roussy role: PRINCIPAL_INVESTIGATOR lat: 46.81228 lon: -71.21454 facility: GSK Investigational Site city: Québec zip: G1V 4G2 country: Canada name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Marie-Louise Vachon role: PRINCIPAL_INVESTIGATOR lat: 46.81228 lon: -71.21454 facility: GSK Investigational Site city: Weinheim state: Baden-Wuerttemberg zip: 69469 country: Germany name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Beate Moeckesch role: PRINCIPAL_INVESTIGATOR lat: 49.54887 lon: 8.66697 facility: GSK Investigational Site city: Wallerfing state: Bayern zip: 94574 country: Germany name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Josef Grosskopf role: PRINCIPAL_INVESTIGATOR lat: 48.68416 lon: 12.88035 facility: GSK Investigational Site city: Wuerzburg state: Bayern zip: 97074 country: Germany name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Tino F Schwarz role: PRINCIPAL_INVESTIGATOR lat: 49.79391 lon: 9.95121 facility: GSK Investigational Site city: Essen state: Nordrhein-Westfalen zip: 45355 country: Germany name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Axel Schaefer role: PRINCIPAL_INVESTIGATOR lat: 51.45657 lon: 7.01228 facility: GSK Investigational Site city: Witten state: Nordrhein-Westfalen zip: 58455 country: Germany name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Thomas Horacek role: PRINCIPAL_INVESTIGATOR lat: 51.44362 lon: 7.35258 facility: GSK Investigational Site city: Mainz state: Rheinland-Pfalz zip: 55116 country: Germany name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Bernhard Schmitt role: PRINCIPAL_INVESTIGATOR lat: 49.98419 lon: 8.2791 facility: GSK Investigational Site city: Berlin zip: 10117 country: Germany name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Sameer Kulkarni role: PRINCIPAL_INVESTIGATOR lat: 52.52437 lon: 13.41053 facility: GSK Investigational Site city: Berlin zip: 10787 country: Germany name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Keikawus Arasteh role: PRINCIPAL_INVESTIGATOR lat: 52.52437 lon: 13.41053 facility: GSK Investigational Site city: Berlin zip: 13347 country: Germany name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Nicole Toursarkissian role: PRINCIPAL_INVESTIGATOR lat: 52.52437 lon: 13.41053 facility: GSK Investigational Site city: Ibaraki zip: 300-0062 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Kota Yamada role: PRINCIPAL_INVESTIGATOR lat: 34.81641 lon: 135.56828 facility: GSK Investigational Site city: Kanagawa zip: 211-0041 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Masamitsu Takahashi role: PRINCIPAL_INVESTIGATOR lat: 37.58333 lon: 139.91667 facility: GSK Investigational Site city: Tokyo zip: 155-0031 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Tomofumi Murakami role: PRINCIPAL_INVESTIGATOR lat: 35.6895 lon: 139.69171 facility: GSK Investigational Site city: Tokyo zip: 180-0022 country: Japan name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Minoru Nozaki role: PRINCIPAL_INVESTIGATOR lat: 35.6895 lon: 139.69171 facility: GSK Investigational Site city: Boksburg state: Gauteng zip: 1459 country: South Africa name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Agatha C Wilhase role: PRINCIPAL_INVESTIGATOR lat: -26.21197 lon: 28.25958 facility: GSK Investigational Site city: Bellville zip: 7530 country: South Africa name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Maria M Pretorius role: PRINCIPAL_INVESTIGATOR lat: -33.90022 lon: 18.62847 facility: GSK Investigational Site city: Mowbray zip: 7700 country: South Africa name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jonathan Peter role: PRINCIPAL_INVESTIGATOR lat: -33.94802 lon: 18.47333 facility: GSK Investigational Site city: Newton zip: 2113 country: South Africa name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Essack Aziz Mitha role: PRINCIPAL_INVESTIGATOR hasResults: False
<\|newrecord\|> nctId: NCT06389474 id: CT-INM004-04 briefTitle: A Phase III Study to Evaluate the Efficacy of INM004 in Children With STEC-HUS overallStatus: NOT_YET_RECRUITING date: 2024-05-16 date: 2025-07-28 date: 2025-09-28 date: 2024-04-29 date: 2024-04-29 name: Inmunova S.A. class: OTHER name: KLIXAR name: Chemo Research name: Linical name: Crovelis briefSummary: The objectives of this study are to evaluate the efficacy, safety, and pharmacokinetics of INM004 in pediatric patients with Hemolytic Uremic Syndrome associated to infection by Shiga toxin-producing Escherichia coli (STEC-HUS). conditions: Hemolytic-Uremic Syndrome studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Adaptive design. IA will be done when approximately 50% of the enrollment is reached and the participants have completed 28 days of follow-up. This analysis will not be blinded and will be carried out to declare futility or re-estimate the sample size. The re-estimation of the sample size will allow a maximum of 300 randomized subjects in total, but a reduction in the initial item size of 220 subjects is not expected. In case of re-estimating the sample size, the smallest sample size under 300 will be selected, which allows a power of ≥ 80%. %. If with 300 subjects, a power of 80% is not reached, but it is ≥ 50%, then the sample size is re-estimated to 300 subjects, as long as the conditional power of the IA is ≥ 50% (promising results) primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 220 type: ESTIMATED name: INM004 name: Placebo measure: Time to recovery of renal function during the acute phase measure: Short-term recovery of renal function measure: MAKE 90 measure: Dialysis longer than 10 days measure: Dialysis requirement measure: Mortality measure: CKD Risk Assessment According to Kidney Disease Improving Global Outcomes (KDIGO) Categories measure: Evolution of renal function at 7 days (GFR_AUC1-7) measure: Evolution of renal function at 28 days (GFR_AUC1-28) measure: Evolution of renal function at 90 days (GFR_AUC1-90) measure: Incidence of anuria measure: Extrarenal composite endpoint measure: Recovery of the thrombotic microangiopathy (TMA), thrombocytopenia measure: Recovery of the thrombotic microangiopathy (TMA), hemolytic anemia measure: Duration of hospitalization measure: Incidence of adverse events of special interest measure: Incidence of adverse events measure: Pharmacokinetic - AUC0-t measure: Pharmacokinetic - AUC0-inf measure: Pharmacokinetic - Cmax measure: Pharmacokinetic - Tmax measure: Pharmacokinetic - λz measure: Pharmacokinetic - t1/2 measure: Pharmacokinetic - Vz measure: Pharmacokinetic - Cl measure: Pharmacokinetic - AUC/dose measure: Pharmacokinetic - Cmax/dose measure: Baseline Shiga toxin serum levels measure: Kinetics of Shiga toxin in serum sex: ALL minimumAge: 9 Months maximumAge: 17 Years stdAges: CHILD facility: Hospital El Cruce - Néstor Kirchner city: Florencio Varela state: Buenos Aires country: Argentina lat: -34.82722 lon: -58.39556 facility: Hospital Interzonal Especializado Materno Infantil Don Victorio Tetamanti city: Mar Del Plata state: Buenos Aires country: Argentina lat: -38.00228 lon: -57.55754 facility: Sanatorio de Niños city: Rosario state: Santa Fe country: Argentina lat: -32.94682 lon: -60.63932 facility: Clínica Zabala city: Ciudad Autonoma de Buenos Aire country: Argentina lat: -34.61315 lon: -58.37723 facility: Hospital de Niños Dr. Ricardo Gutierrez city: Ciudad Autonoma de Buenos Aire country: Argentina lat: -34.61315 lon: -58.37723 facility: Hospital de Niños de la Santísima Trinidad city: Córdoba country: Argentina lat: -31.4135 lon: -64.18105 facility: Sanatorio Allende city: Córdoba country: Argentina lat: -31.4135 lon: -64.18105 facility: Hospital Pediátrico Dr. Humberto Notti city: Mendoza country: Argentina lat: -32.89084 lon: -68.82717 hasResults: False
<\|newrecord\|> nctId: NCT06389461 id: OST1_012 briefTitle: 4th Ventricular Compression Technique on Anxiety overallStatus: NOT_YET_RECRUITING date: 2024-09-16 date: 2024-12-31 date: 2024-12-31 date: 2024-04-29 date: 2024-04-29 name: Escola Superior de Tecnologia da Saúde do Porto class: OTHER briefSummary: Determinate the effects of the technique of 4th ventricle in college students with anxiety, applying the technique one time per week during three weeks. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: 4th Ventricular Compression Technique name: "Sham" Therapy measure: Change from baseline in anxiety levels through the STAI (The State-Trait Anxiety Inventory) questionnaire score on the 1st and last intervention. measure: Change from baseline in thoraco-abdominal perimetry on the 1st and last intervention sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Escola Superior da Saúde do Porto city: Porto zip: 4200-072 country: Portugal lat: 41.14961 lon: -8.61099 hasResults: False
<\|newrecord\|> nctId: NCT06389448 id: pCLE vs EB 2024tj briefTitle: Comparison of pCLE and EB in Gastric Lesion Diagnosis overallStatus: RECRUITING date: 2024-04-11 date: 2026-04 date: 2026-10 date: 2024-04-29 date: 2024-04-29 name: Huazhong University of Science and Technology class: OTHER briefSummary: This is a prospective multicenter comparative study, aiming to compare probe-based confocal laser endomicroscopy (pCLE) and endoscopic biopsies in the diagnosis of the whole specific gastric lesion especially for distinguishing low grade intraepithelial neoplasia (LGIN) from high grade intraepithelial neoplasia (HGIN) and create an endoscopic image database for the follow-up research. conditions: Low Grade Intraepithelial Neoplasia conditions: High Grade Intraepithelial Neoplasia conditions: Early Gastric Cancer conditions: Gastric Intraepithelial Neoplasia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Participants undergo pCLE after pre-ESD assessment and before ESD resection. primaryPurpose: DIAGNOSTIC masking: NONE count: 366 type: ESTIMATED name: pCLE-gastr measure: Diagnostic accuracy of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion measure: The histological upstaging rate of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430030 country: China name: Bin Cheng, Professor role: CONTACT phone: 86-027-8366-3333 email: bcheng@tjh.tjmu.edu.cn name: Yilin Gu role: CONTACT phone: 86-19884836004 email: yilingu2019@163.com lat: 30.58333 lon: 114.26667 hasResults: False
<\|newrecord\|> nctId: NCT06389435 id: 2024DS id: Knee type: OTHER domain: Danderyds sjukhus briefTitle: RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques acronym: ROCKETS overallStatus: RECRUITING date: 2024-03-04 date: 2027-01 date: 2028-01 date: 2024-04-29 date: 2024-04-29 name: Danderyd Hospital class: OTHER name: Karolinska Institutet name: Stockholm South General Hospital briefSummary: Rationale for conducting the study:
The study aims to systematically evaluate the clinical and economic impacts of Robotic-Assisted Total Knee Replacement (RTKR) compared to conventional Total Knee Replacement (TKR). It focuses on the potential benefits of RTKR, including improved precision in surgery, potentially leading to better patient outcomes and reduced healthcare costs. Our primary endpoint is the Forgotten Joint Score (FJS), aimed at measuring patients awareness of their knee joint in everyday life, indicating the success of the knee replacement surgery in restoring natural joint function. Secondary endpoints include patient-reported outcome measures (PROMs), patient activity levels, the accuracy of implant positioning on x-ray, and the incidence of adverse events.
Study design:
Multicentre,, preference-tolerant, randomized, controlled, superiority trial with two treatment arms that compares the outcomes of RTKR with traditional TKR techniques.
Study population:
Adult patients aged 18 years and older who are eligible for TKR as per local guidelines and who have given informed consent to participate in the study.
Number of patients:
400
Inclusion criteria:
Patients must be adults aged 18 years and older, eligible for TKR according to local guidelines, and willing to participate in the study.
Exclusion criteria:
Patients with extreme malalignment requiring special implants or techniques, patients unfit for surgery due to medical reasons, and those deemed unsuitable to participate in the study for other reasons.
Primary outcome variables:
The Forgotten Joint Score (FJS) at 2 years after surgery conditions: Knee Arthroplasty, Total conditions: Robotic-assisted conditions: Osteoarthritis of the Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: Patients will be randomized to undergo TKR or RTKR measure: The Forgotten Joint Score (FJS) measure: KOOS measure: ADLS knee instability measure: The Forgotten Joint Score (FJS) measure: EQ-5D measure: Knee alignment measure: Adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Danderyds Sjukhus status: RECRUITING city: Stockholm zip: 18288 country: Sweden name: Olof Skoldenberg, Md, PhD role: CONTACT phone: 800-555-5555 email: olof.skoldenberg@ki.se name: Olof Skoldenberg, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Karl Erikson, MD, PhD role: SUB_INVESTIGATOR lat: 59.33258 lon: 18.0649 hasResults: False
<\|newrecord\|> nctId: NCT06389422 id: NCC4620 briefTitle: Phase II Study of Moderate-dose Hypofractionated RT Combined With Pembrolizumab for HCC With Diffuse Tumor Thrombosis overallStatus: RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2027-04-30 date: 2024-04-29 date: 2024-04-29 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: This is a single-center, single-arm, open-label study that includes patients meeting the inclusion criteria (liver-GTV volume \< 700ml or estimated liver-GTV V5 \< 300ml) with hepatocellular carcinoma with diffuse tumor thrombosis involving both left and right lobes. All lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy, with a gross tumor dose of 25Gy/5f, and a maximum dose of 35Gy/5f at the tumor center. One week before or during the radiotherapy, patients receive concurrent Pembrolizumab at a dose of 200mg. Subsequently, Pembrolizumab is administered intravenously every 3 weeks. Follow-up examinations are conducted 1-3 months post-radiotherapy. Lenvatinib 4mg may be used for maintenance therapy with Pembrolizumab if there are no contraindications. Maintenance therapy is continued until disease progression or intolerance. The primary endpoint is median overall survival (mOS), and secondary endpoints include objective response rate (ORR), progression-free survival (PFS), and toxicity. conditions: Hepatocellular Carcinoma conditions: Radiotherapy conditions: Pembrolizumab conditions: Tumor Thrombosis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Moderate-dose Hypofractionated Intensity-modulated Radiotherapy name: Pembrolizumab measure: Median Overall Survival measure: Objective Response Rate measure: Progression-free Survival measure: Toxicity sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College status: RECRUITING city: Beijing state: Beijing country: China name: Bo Chen, MD role: CONTACT phone: 0086-13240000876 email: chenboo@outlook.com lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06389409 id: Protocollo N.2009 Testicolo briefTitle: Study on the Quality of Life and Functional/Oncological Outcome of Testicular Cancer Patients overallStatus: RECRUITING date: 2010-08-24 date: 2030-09-01 date: 2040-08-31 date: 2024-04-29 date: 2024-04-29 name: IRCCS San Raffaele class: OTHER briefSummary: The research aims to collect data in order to report the main problems related to the testicular cancer; To reach this aim, this study proposes to create a database of the testicular cancer condition.
From this perspective, the aim of this project is the improving of scientific knowledge of the disease and develop appropriate and effective procedures for the diagnosis and treatment of the patient. conditions: Testicular Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED name: Observation of testicular cancer patients measure: Clinical data measure: Adjuvant therapy measure: lactate dehydrogenase measure: Testicular objective examination measure: Testicular objective examination - cysts measure: Testicular objective examination - nodules measure: Testicular objective examination - varicocele measure: Testicular objective examination - hydrocele measure: α-feto protein measure: β human Chorionic Gonadotropin measure: carcinoembryonic antigen sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale San Raffaele status: RECRUITING city: Milan state: Lombardy zip: 20132 country: Italy name: Alessia d'Arma, PhD role: CONTACT phone: 02 2643 5506 email: darma.alessia@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False

End of preview. Expand in Dataset Viewer.

README.md exists but content is empty. Use the Edit dataset card button to edit it.

Downloads last month: 1

Edit dataset card

Size of downloaded dataset files:

10.7 MB

Size of the auto-converted Parquet files:

10.7 MB

Number of rows:

22,021