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1. Does postoperative dexmedetomidine reduce the incidence of delirium after lung surgery? |
2. Does postoperative dexmedetomidine introduce other medical problems? Researchers will compare dexmedetomidine and sufentanil to see if dexmedetomidine works to reduce delirium. |
Participants will undergo routine postoperative care: |
1. Patient-controlled self anesthesia with sufentanil only or combination of sufentanil and dexmedetomidine |
2. Postoperative visit twice a day for at least seven days conditions: Delirium in Old Age conditions: Anesthesia; Adverse Effect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 287 type: ACTUAL name: Dexmedetomidine injection name: Sufentanil injection measure: Incidence of postoperative delirium measure: Incidence of postoperative nausea and vomiting measure: incidence of postoperative complications measure: Pain intensities sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Kunming Children's Hospital city: Kunming state: Yunnan zip: 650100 country: China lat: 25.03889 lon: 102.71833 hasResults: False |
<|newrecord|> nctId: NCT06382948 id: MedOPP545 id: 2024-512926-27-00 type: CTIS briefTitle: Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. acronym: ADELA overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-09 date: 2028-04 date: 2024-04-24 date: 2024-04-26 name: MedSIR class: OTHER name: Stemline Therapeutics, Inc. briefSummary: This trial will study a type of advanced breast cancer (ABC) defined as endocrine receptor (ER)-positive/human epidermal growth factor receptor 2(HER2)-negative and estrogen receptor 1 (ESR1)-mutated. Patients will be treated with elacestrant, a compound that acts as a selective estrogen receptor degrader, and everolimus (or placebo), a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer. |
The main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of elacestrant plus everolimus therapy in patients who have ER-positive/HER2-negative, ESR1-mutated, ABC progressing to endocrine therapy and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus (or placebo) treatment initiation until to the first occurrence of disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason, whichever occurs first, defined as progression free survival. |
Rigorous eligibility criteria based on specific co-morbidities and clinicopathologic features of their disease have been designed to minimize the risk of patients participating in this study. The anticipated favorable clinical benefits of elacestrant combined with everolimus are projected to outweigh the risks of this treatment. This study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations. conditions: Advanced Breast Cancer conditions: ER-positive Breast Cancer conditions: HER2-negative Breast Cancer conditions: ESR1 Gene Mutation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-blind, parallel group (two arms: elacestrant plus everolimus, and elacestrant plus placebo). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: A blinded, independent IRC will perform a review of radiographic images and clinical information collected on study to determine the protocol-defined endpoints of disease response and progression. Further information on the independent review process will be provided in the BIRC Charter. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 240 type: ESTIMATED name: Everolimus name: Elacestrant name: Placebo name: Auxiliary Medicinal Product - Dexamethasone name: Auxiliary Medicinal Product - Luteinizing hormone-releasing hormone (LHRH) analogues measure: To demonstrate superiority of elacestrant+everolimus vs. elacestrant+placebo in prolonging PFS based on a BIRC in patients with ER[+]/HER2[-], ESR1-mutated, ABC that have previously received ET+CDK4/6i (all patients). measure: To compare overall survival (OS) between treatment groups, in all patients. measure: To compare investigator-assessed PFS based on local assessment between treatment groups, in all patients. measure: To compare objective response rate (ORR) between treatment groups, in all patients. measure: To compare clinical benefit rate (CBR) between treatment groups, in all patients. measure: To compare overall time to response (TTR) between treatment groups, in all patients. measure: To compare duration of response (DoR) between treatment groups, in all patients. measure: To compare best percentage of change in tumor burden between treatment groups, in all patients. measure: To describe the changes in health-related quality-of-life (HRQoL) from baseline using the EuroQoL 5 Dimension 5 Level (EQ-5D-5L) scale. measure: To describe the changes in HRQoL from baseline using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). measure: To describe the changes in HRQoL from baseline using the EORTC Quality of Life Questionnaire Breast Cancer module (EORTC QLQ-BR45). measure: To assess adverse events (AEs) between treatment groups in all patients. measure: To assess adverse events leading to study treatment withdrawal. measure: To assess adverse events leading to dose modification. measure: To assess the number of participants with abnormal hematology and/or chemistry values that are related to treatment. measure: To assess the number of participants with changes on vital signs and/or AEs that are related to treatment. measure: To assess the number of participants with changes on cardiac function measured by ECG QT Interval Corrected by Fridericia formula (QTcF) that are related to treatment effect . measure: To assess the number of participants with changes on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) that are related to treatment. measure: Exploratory endpoint: protein expression studies using blood samples to investigate the potential association with clinical outcomes. measure: Exploratory endpoint: analysis of allele mutation frequencies in circulating tumor DNA (ctDNA) in blood samples to investigate the potential association with clinical outcomes. measure: Exploratory endpoint: Genetic studies using blood samples to investigate the potential association with clinical outcomes. measure: Exploratory endpoint: Analysis of medical imaging (radiomics) to identify potential biomarkers associated with clinical outcomes. measure: Exploratory endpoint: Pharmacokinetic (PK) parameter of maximum (Peak) Observed Serum Concentration (Cmax). measure: Exploratory endpoint: Pharmacokinetic (PK) parameter of Plasma Through Concentration (Ctrough). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06382935 id: 34-24 briefTitle: Impact of Non-surgical Periodontal Treatment of miRNome overallStatus: RECRUITING date: 2024-04-20 date: 2024-09-22 date: 2024-10-15 date: 2024-04-24 date: 2024-04-24 name: University of Catania class: OTHER briefSummary: A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment by means of minimally invasive approach MINST or Q-SI (quadrantwise) approach in subjects with periodontitis on miRNome in gingival crevicular fluid conditions: Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Non-surgical periodontal treatment Subgingival biofilm ultrasonic debridement with MINST or Q-SI primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Sealed envelopes whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Probin Pocket Depth reduction measure: Probing Pocket Depth sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AOU Policlinico G. Rodolico status: RECRUITING city: Catania zip: 95124 country: Italy name: Gaetano Isola, DDS role: CONTACT phone: 0953785652 email: [email protected] lat: 37.49223 lon: 15.07041 hasResults: False |
<|newrecord|> nctId: NCT06382922 id: PAPAML022019 briefTitle: Role of Antifungal Prophylaxis in Elderly Patients With Acute Myeloid Leukemia During Consolidation Therapy overallStatus: RECRUITING date: 2023-03-29 date: 2024-07-30 date: 2025-06-01 date: 2024-04-24 date: 2024-04-29 name: University of Rome Tor Vergata class: OTHER briefSummary: In previous retrospective study (SEIFEM 2016 study) the investigators evaluated the incidence of proven/probable invasive aspergillosis (IA) and the role of mold active primary antifungal prophylaxis (PAP) in a "real life" setting of acute myeloid leukemia (AML )patients receiving intensive consolidation therapy. All cases of proven/probable IA, observed during consolidation chemotherapy in adult and pediatric AML patients between 2011 and 2015, were retrospectively collected in a multicenter study involving 38 Italian hematologic centers. The investigators observed 56 (2.2%) cases of IA \[43 probable (1.7%) and 13 proven (0.5%)\]. The overall mortality rate and the mortality rate attributable to IA (AMR) on day 120 were 16% and 9%, respectively. In multivariate analysis, parameters that influenced the outcome were age ≥60 years and treatment with high doses of cytarabine (HDAC). |
The investigators also observed that centers involved in this survey had different antifungal policies during the AML consolidation phase. The results from this study show that in a large real-world setting the mold active PAP, with itraconazole or posaconazole, decreases the rate of IA after consolidation course. |
In SEIFEM 2016 study the investigators demonstrated that the incidence of IA during the AML consolidation is low. However, the mortality is not negligible, mainly in older patients. Further, a sub-analysis in the subset of patients older than 60 years demonstrated that patients who didn't receive mold active prophylaxis had higher incidence of IA than patients who received mold active prophylaxis (15% vs 6%). Therefore, as prophylaxis seems to prevent IA in consolidation, further studies should be performed especially in elderly patients treated with HDAC to confirm our data and to identify the subset of patients who require PAP. conditions: Invasive Aspergillosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: the incidence of proven, probable and possible IA in patients enrolled in the study in both groups of patients measure: overall mortality rate sex: ALL minimumAge: 60 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tor Vergata University status: RECRUITING city: Roma state: RM zip: 00133 country: Italy name: Maria Ilaria Del Principe role: CONTACT phone: 3394080659 email: [email protected] lat: 41.89193 lon: 12.51133 hasResults: False |
<|newrecord|> nctId: NCT06382909 id: 202302 briefTitle: Effect of Probiotic Compound K11T e K11TMax in ASD acronym: ASD overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-22 date: 2024-07-07 date: 2025-04-07 date: 2024-04-24 date: 2024-04-29 name: Deivis de Oliveira guimaraes class: NETWORK name: SENAI CIMATEC briefSummary: The research is characterized as a randomized, double-blind clinical trial (phase III) in which administered the probiotic K11-T (with and without added amino acids, fatty acids and vitamins) to children between 3 and 11 years old with Autism Spectrum Disorder - ASD, being subsequently assessed outcomes related to inflammatory markers and neuropsychiatric and sociopedagogical criteria. To this end, the study will create three groups, one of which will be a control group, which will receive a placebo, the other will receive the probiotic without micronutrients and another will receive the probiotic with added nutrients. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double blind, randomized, with placebo control primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 505 type: ACTUAL name: Inflammatory level name: Cognitive assessment name: Pedagogical assessment measure: Inflammation biomarker 1 measure: Inflammation biomarker 2 measure: Inflammation biomarker 3 measure: Inflammation biomarker 4 measure: Inflammation biomarker 5 measure: Neuropsychological Assessment measure: Psychiatric Assessment measure: Psychopedagogical Assessment measure: Comparative of outcomes between arm that took K11-T and arm that took K11-Tmax. sex: ALL minimumAge: 3 Years maximumAge: 11 Years stdAges: CHILD facility: Gon1 P&D city: Vitoria state: ES zip: 29050335 country: Brazil lat: -20.31944 lon: -40.33778 facility: Gon1 gestora de Projetos city: Vitória state: ES zip: 29050335 country: Brazil lat: -20.31944 lon: -40.33778 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-22 uploadDate: 2024-04-18T21:12 filename: Prot_000.pdf size: 369916 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-22 uploadDate: 2024-04-16T10:55 filename: ICF_001.pdf size: 192688 hasResults: False |
<|newrecord|> nctId: NCT06382896 id: FirstAHXiamenU-YB-2 briefTitle: Effect of Oliceridine on Rebound Pain overallStatus: RECRUITING date: 2024-01-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-24 date: 2024-04-25 name: The First Affiliated Hospital of Xiamen University class: OTHER briefSummary: The purpose of this clinical study was to identify the risk factors for postoperative pain outburst in patients undergoing arthroscopic knee surgery after Oliceridine and nerve block, and to evaluate the effect of oxeridine on early rehabilitation exercise in patients. A total of 320 patients undergoing arthroscopic knee arthroscopy under general anesthesia combined with femoral nerve block were selected to record the time and duration of postoperative pain outbreak, pain degree, age, gender, operation type, previous surgical history and other related risk factors. conditions: Rebound Pain conditions: Arthroscopic Knee Surgery conditions: Oliceridine studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 320 type: ESTIMATED name: No intervention measure: Time of onset of postoperative rebound pain measure: The duration of the rebound pain measure: The degree of the rebound pain measure: age measure: sex measure: Surgical procedure measure: Previous surgical history measure: Movement recovery time sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital of Xiamen University status: RECRUITING city: Xiamen state: Fujian zip: 361000 country: China name: Bin Yang, doctor role: CONTACT phone: 13859986036 email: [email protected] lat: 24.47979 lon: 118.08187 hasResults: False |
<|newrecord|> nctId: NCT06382883 id: FINELO2024 briefTitle: Lifestyle and Physical Activity as Part Of Obstructive Sleep Apnea Treatment acronym: ELO overallStatus: RECRUITING date: 2024-04-22 date: 2026-07-31 date: 2026-07-31 date: 2024-04-24 date: 2024-04-24 name: Filha ry class: OTHER name: University of Jyvaskyla name: Organisation for Respiratory Health in Finland name: Central Finland Hospital District briefSummary: The goal of this clinical trial is to investigate the effects of an individually tailored lifestyle intervention on symptoms and severity of obstructive sleep apnea (OSA), physical activity (PA) levels and sedentary behavior (SB), as well as health and wellbeing in overweight participants with moderate to severe OSA treated with CPAP. Emphasis of the individually tailored SEMC-intervention (protocol of the Sports Medicine Outpatient Clinic of The Wellbeing Services County of Central Finland) is on increasing the amount of total physical activity. |
The main questions the trial aims to answer are: |
* Can individually tailored lifestyle intervention, in combination with CPAP therapy, alleviate the severity or symptoms of OSA in overweight participants with moderate to severe OSA? |
* Does the addition of an individually tailored lifestyle intervention to CPAP therapy improve the quality of life, increase physical functioning, change body composition, and increase physical activity levels or decrease sedentary behavior of participants diagnosed with moderate to severe OSA? |
* Can enhanced behavioral support (EBS), when integrated with lifestyle intervention and CPAP therapy, lead to more substantial and enduring changes in participants' levels of physical activity or sedentary behavior? |
Participants will be randomized to either SEMC-intervention group, combination of SEMC-intervention and EBS, or to a control group. |
In this study, it is hypothesized that participants receiving SEMC-intervention in combination with CPAP therapy will experience greater alleviation of OSA severity and symptoms, improve their quality of life, body composition and physical functioning, as well as increase physical activity levels and decrease their sedentary behavior compared to the control group. In addition, it is hypothesized that participants receiving SEMC-intervention and EBS in combination with CPAP therapy will increase their physical activity levels, and decrease their sedentary behavior to a greater extent, and these changes will be more sustained compared to merely SEMC-intervention or control group. conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Individually tailored lifestyle and physical activity intervention name: Individually tailored lifestyle and physical activity intervention combined with enhanced behavioral support -intervention (EBS) measure: Change in apnea-hypopnea-index (AHI) measure: Change on sleep apnea symptoms measure: Change in the mean daily total light physical activity time measure: Change in the mean daily total moderate to vigorous (MVPA) physical activity time measure: Change in the mean daily total sedentary time measure: Change in 6-minute walk distance (6MWD) in meters measure: Change in hand grip strength in kilograms measure: Change in waist circumference in centimeters measure: Change in body weight in kilograms measure: Change in visceral fat area (VFA) in square centimeters measure: Change in muscle mass in kilograms measure: Change in Quality of Life RAND 36-Item Health Survey sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Central Finland Hospital District status: RECRUITING city: Jyväskylä zip: 40620 country: Finland name: Merja Perhonen role: CONTACT email: [email protected] name: Antti Saarinen role: CONTACT email: [email protected] lat: 62.24147 lon: 25.72088 hasResults: False |
<|newrecord|> nctId: NCT06382870 id: 107.2023fbu briefTitle: Simulation-Based Training for Child Neglect and Abuse overallStatus: NOT_YET_RECRUITING date: 2024-05-29 date: 2024-06-15 date: 2024-06-29 date: 2024-04-24 date: 2024-04-24 name: Fenerbahce University class: OTHER briefSummary: Child abuse and neglect is a broad structure that includes physical abuse, sexual abuse, emotional abuse and neglect. Child neglect and abuse is one of the primary areas of responsibility of health professionals, which negatively affects child health and threatens public health in the long term. All healthcare professionals are legally obligated to report known or suspected cases of child abuse and neglect. Health professionals, in particular, play an important role in stopping child abuse by assessing children, identifying risk factors, and reporting suspected child maltreatment to authorities. Early diagnosis of a neglected and abused child is important in reducing the recurrence of maltreatment. |
Regarding the evaluation of child neglect and abuse, healthcare professionals should approach a child who presents with suspicious injuries, thinking that he or she may be abused. The key here is to be aware of the problem. Health professionals should carefully examine children and fulfill their responsibilities by identifying possible clues to abuse and neglect. It is recommended that clues to recognize neglect and abuse be taught within the scope of in-service training for healthcare professionals working in hospitals. conditions: Simulation-based Training studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 24 type: ESTIMATED name: education measure: The awareness level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06382857 id: 823779-MDF Niger briefTitle: Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition overallStatus: RECRUITING date: 2024-05-02 date: 2025-11-01 date: 2026-02-01 date: 2024-04-24 date: 2024-04-29 name: Epicentre class: OTHER name: Epicentre, Niger name: National Nutrition Direction, Niger name: Ministry of Public Health and Social Affairs, Niger name: Regional Direction of Public Health, Maradi briefSummary: This study is an individually randomized controlled trial comparing microbiome-directed foods to standard nutritional therapy among children aged 6 to \< 24 months with uncomplicated acute malnutrition in terms of programmatic recovery by 12 weeks from admission and sustained recovery at 24 weeks from admission. conditions: Malnutrition, Child studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 7356 type: ESTIMATED name: MDF name: RUTF name: RUSF measure: Programmatic recovery by 12 weeks from admission measure: Sustained recovery at 24 weeks from admission measure: Default measure: Non-response measure: Time to recovery measure: For MAM children: Deterioration to SAM measure: Change in weight gain measure: Change in weight-for-length Z (WLZ) measure: Change in length-for-age Z (LAZ) measure: Change in weight-for-age Z (WAZ) measure: Change in MUAC measure: Serious adverse events measure: Hospitalization measure: Death measure: Motor, cognitive, language, social-emotional, and mental health skills measure: Cost effectiveness measure: Dietary intake measure: Adherence measure: Microbiome profile at enrollment, week 4, program discharge, and study discharge measure: Plasma proteome profile at enrollment, week 4, program discharge, and study discharge measure: Environmental enteric dysfunction at enrollment, program discharge, and study discharge measure: Change of fat mass and fat-free mass at program discharge and study discharge measure: Micronutrient status at enrollment, program discharge and study discharge measure: Immuno-sufficiency at week 2, week 4, program discharge, week 12 and study discharge (SAM only) sex: ALL minimumAge: 6 Months maximumAge: 23 Months stdAges: CHILD facility: Epicentre Niger status: RECRUITING city: Maradi country: Niger name: Ousmane Guindo, MD role: CONTACT email: [email protected] name: Ibrahim Ngoumboute, MD role: CONTACT email: [email protected] lat: 13.5 lon: 7.10174 hasResults: False |
<|newrecord|> nctId: NCT06382844 id: PI23/00486 id: PI2023 08 1416 type: REGISTRY domain: Ethics Committee for Drug Research of the Salamanca Health Area briefTitle: Novel Flow-cytometry Approaches to Improve the Detection of Tumor Cells in CTCL overallStatus: RECRUITING date: 2024-01-01 date: 2026-09-30 date: 2026-12-31 date: 2024-04-24 date: 2024-04-25 name: Instituto de Investigación Biomédica de Salamanca class: OTHER name: Carlos III Health Institute briefSummary: Identification and quantitation of circulating tumor cells in patients with cutaneous T-cell lymphoma -mycosis fungoides (MF)/Sézary syndrome (SS)- are required for diagnosis and precising the actual staging and response to treatment. The current flow cytometry techniques used in clinical laboratories do not correctly allow to compare results in a clinical setting. Furthermore, now we know that the phenotype of tumor cells partially overlaps with that of normal TCD4+ cells, and it is rather heterogeneous. The GENERAL OBJECTIVE of this project is to apply flow-cytometry standardized strategies for rapid, specific, sensitive, and reproducible detection and quantitation of tumor cells in patients with MF/SS. For this purpose, in the first phase of the project we will design an optimal combination of markers to detect tumor cells by spectral flow-cytometry, and then the specificity and analytical sensitivity of the new combination/procedure will be assessed in blood samples -to be later applied to skin samples-, and finally reference databases will be created for the automatic analysis of cytometry data. In a second phase of the project, the developed method will be validated in a multicenter manner, through the demonstration of its practical applicability and clinical utility (speed and precision) in blood samples (and skin, where appropriate) for diagnosis, staging, and treatment monitoring. In parallel, the tumor microenvironment (residual normal immune system) will be explored -by applying the panel designed in the first phase together with additional immune-monitoring panels by flow cytometry-, and its relationship with clinical-biological heterogeneity of the tumor will be analyzed. In the two phases of the project, cytometry data will be compared with the gold standard approach to identify tumor T cells (through the identification of clonal rearrangement by PCR and/or NGS, performed on cell populations previously sorted by flow cytometry). conditions: Cutaneous T-Cell Lymphoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Detection and quantitation of (blood) tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS). measure: Optimizing Marker Combination for Specific Identification and Quantification of Sézary Cells using Spectral Flow Cytometry sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto de Investigación Biomédica de Salamanca (IBSAL) status: RECRUITING city: Salamanca zip: 37007 country: Spain name: Ricardo López Pérez, PhD role: CONTACT phone: +34 923 29 12 00 phoneExt: 55144 email: [email protected] name: Esperanza López Franco, PhD role: CONTACT phone: +34 923 29 12 00 phoneExt: 55779 email: [email protected] lat: 40.96882 lon: -5.66388 hasResults: False |
<|newrecord|> nctId: NCT06382831 id: IndonesiaU240201 briefTitle: Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-08-01 date: 2024-10-01 date: 2024-04-24 date: 2024-04-24 name: Indonesia University class: OTHER briefSummary: Anesthesia without the use of opioid (Opioid free anesthesia) is an alternative to conventional opioid balanced anesthesia, with less post operative nausea and vomiting, and comparable analgesia. This study aim to compare the effect of opioid free versus opioid balanced anesthesia in ophthalmology surgery conditions: Anesthesia and Analgesia conditions: Anesthesia, Endotracheal studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 104 type: ESTIMATED name: Dexmedetomidine name: Fentanyl measure: Postoperative nausea and vomiting (PONV) measure: Pain score measure: Time to laryngeal mask exertion measure: Adverse effect sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06382818 id: PROICM 2023-10 PRO briefTitle: Personalization of Breast Radiotherapy According to Loco-regional Recurrence Risk and Toxicity Probability acronym: PROBA overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2027-04-26 date: 2036-04-26 date: 2024-04-24 date: 2024-04-24 name: Institut du Cancer de Montpellier - Val d'Aurelle class: OTHER briefSummary: Our objective is based on a personalized approach of adjuvant breast radiotherapy by selecting patients according to tumor recurrence and toxicity risk. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: * COHORT A = Low risk of recurrence / Low risk of breast toxicity |
* COHORT B = Low risk of recurrence / High risk of breast toxicity |
* COHORT C = High risk of recurrence / Low risk of breast toxicity |
* COHORT D = High risk of recurrence / High risk of breast toxicity primaryPurpose: TREATMENT masking: NONE count: 854 type: ESTIMATED name: COHORT A name: COHORT B name: COHORT C name: COHORT D measure: Rate of patients without any grade 2 or more fibrosis, nor radio-induced sarcoma measure: Acute toxicity measure: Late toxicity measure: Local recurrence rate (LRR) measure: Relapse-free survival (RFS) rate measure: Overall survival (OS) rate measure: Radiation-induced Breast Sarcoma prevalence sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institut Du Cancer de Montpellier city: Montpellier country: France name: MOUSSION AURORE role: CONTACT phone: 0467613102 email: [email protected] name: AZRIA DAVID role: PRINCIPAL_INVESTIGATOR name: MEGE ALICE role: PRINCIPAL_INVESTIGATOR name: BRETON-CALLU CHRISTEL role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 hasResults: False |
<|newrecord|> nctId: NCT06382805 id: HasanKU_FTR_AA_02 briefTitle: Comparison of the Effects of Kinesio Tape and High-intensity Laser Therapy in Lateral Epicondylitis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-01 date: 2024-11-15 date: 2024-04-24 date: 2024-04-25 name: Hasan Kalyoncu University class: OTHER briefSummary: Lateral epicondylitis is a common upper extremity disease that occurs with tenderness in the lateral epicondyle, the common attachment point of the wrist extensor muscles, and pain during resisted wrist extension. The main purpose of treating lateral epicondylitis is to reduce pain and increase functionality, but there is no accepted standard treatment method. The purpose of this study is to compare the effectiveness of kinesio tape and high intensity laser in the treatment of lateral epicondylitis. conditions: Tennis Elbow conditions: Physical Therapy conditions: Kinesiotaping conditions: Laser studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are three groups in the study. The groups consist of the control group, kinesio tape group and high intensity laser group primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Physiotherapy program name: Kinesio Tape name: High Intensity Laser therapy measure: Pain Measurement measure: Hand grip strength measure: Patient-Rated Tennis Elbow Evaluation measure: Pain Sensitivity Measurement sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hasan Kalyoncu University city: Gaziantep zip: 27000 country: Turkey lat: 37.05944 lon: 37.3825 hasResults: False |
<|newrecord|> nctId: NCT06382792 id: 2024PI059 briefTitle: Osteolysis of Allograft Prosthetic Composite After Shoulder Resection for Tumors overallStatus: ENROLLING_BY_INVITATION date: 2024-05-01 date: 2024-05-01 date: 2024-05-01 date: 2024-04-24 date: 2024-04-24 name: Central Hospital, Nancy, France class: OTHER briefSummary: The gold standard after shoulder resection for tumors is reconstruction by reverse prosthesis and allograft. This is an intervention also performed for more frequent etiologies (revisions of prosthesis, non cancerous humeral bone loss ...). |
The results in these etiologies are good, and do not find any particular mechanical complications (including no osteolysis of the graft). In the case of reconstruction for cancer, the numbers of patients are lower (rare pathologies) and some studies on small numbers found osteolysis of the allograft. The aim of this study is to analyze the presence or not osteolysis in these patients, and to quantify it precisely by scanner measurement (no data yet in the literature). conditions: Shoulder Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 6 type: ESTIMATED name: proximal humeral resection for tumor and allograft prosthetic composite reconstruction measure: Osteolysis (bone stock in cm3) measure: Constant score measure: Complications measure: Revision sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Central Hopital city: Nancy zip: 54000 country: France lat: 48.68439 lon: 6.18496 hasResults: False |
<|newrecord|> nctId: NCT06382779 id: 2024PI057 briefTitle: Proximal Humerus Reconstruction After Resection for Tumors : Comparison Between Allograft Prosthetic Composite and Cement Sleeve Prosthetic Composite overallStatus: ENROLLING_BY_INVITATION date: 2024-04-15 date: 2024-05-01 date: 2024-05-01 date: 2024-04-24 date: 2024-04-24 name: Central Hospital, Nancy, France class: OTHER briefSummary: Proximal humerus is a common site for primary bone tumors and metastatic disease. Reconstruction with reverse shoulder arthroplasty (RSA) after resection is a surgical challenge and presented high risk of complication. The options for reconstruction after proximal humerus tumor resection are limited, and depend on the soft tissue conditions and bone loss. The most commonly used techniques include long cemented stem alone (in case of limited resection), allograft prosthetic composite (APC), massive prosthesis. In some cases two step procedure are performed : first step is resection and RSA with cement sleeve, and second step is APC or massive prosthesis. conditions: Shoulder Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 32 type: ESTIMATED name: reverse shoulder arthroplasty measure: Constant score measure: complication measure: mortality measure: revision sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHRU - Centre chirurgical emile galle city: Nancy zip: 54000 country: France lat: 48.68439 lon: 6.18496 hasResults: False |
<|newrecord|> nctId: NCT06382766 id: SMU in malnutrition briefTitle: Skeletal Muscle Ultrasonography in Detection of Malnutrition overallStatus: NOT_YET_RECRUITING date: 2025-03 date: 2026-03 date: 2026-03 date: 2024-04-24 date: 2024-04-24 name: Assiut University class: OTHER briefSummary: * To detect the role of Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome among critically ill children. |
* To assess the accuracy and validity of muscle ultrasonography in assessment of the nutritional status of critically ill child compared with other different nutritional assessment tools . conditions: Skeletal Muscle Ultrasonography studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: Skeletal Muscle Ultrasonography measure: accuracy of Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome among critically ill children comared with other traditional nutritional assessment tools . sex: ALL minimumAge: 1 Month maximumAge: 5 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06382753 id: 20-24-PAR briefTitle: Impact of Periodontal Supportive Therapy in Patients With Gingivitis and Periodontitis overallStatus: RECRUITING date: 2024-04-20 date: 2024-06-30 date: 2024-06-30 date: 2024-04-24 date: 2024-04-24 name: University of Catania class: OTHER briefSummary: The study evaluated the number of sessions of periodontal supportive treatment in patients with gingivitis in order to evaluate the risk of periodontitis development. conditions: Gingivitis conditions: Periodontitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED name: Gingival inflammation measure: Bleeding on Probing sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AOU Policlinico G. Rodolico status: RECRUITING city: Catania zip: 95124 country: Italy name: Gaetano Isola, DDS role: CONTACT phone: 0953785652 email: [email protected] lat: 37.49223 lon: 15.07041 hasResults: False |
<|newrecord|> nctId: NCT06382740 id: AOP2097 briefTitle: Selection Protocol for Liver Transplantation in Patients Aged Over 70 Years acronym: Over70-LT overallStatus: RECRUITING date: 2022-10-01 date: 2025-10-01 date: 2025-10-01 date: 2024-04-24 date: 2024-04-24 name: Azienda Ospedaliera di Padova class: OTHER briefSummary: Increased life expectancy and aging population has led to a trend of increasing liver transplant (LT) volume in the elderly. Nowadays, advanced age is not considered an absolute contraindication for LT but elderly LT candidates typically have an age-associated burden of comorbid conditions that can pose several clinical challenges during the selection/evaluation process for LT. Specific algorithms for elderly patient selection for LT are not well established; however, consensus agreement is that elderly LT candidates need a more rigorous selection process. |
This study proposes a "step by step" algorithm of selection for liver transplant candidates more than 70 years. conditions: End Stage Liver DIsease conditions: Liver Transplantation conditions: Old Age studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 18 type: ESTIMATED name: Liver transplantation measure: 1 year patient survival measure: 1 year graft survival measure: 3 months mortality and morbidity sex: ALL minimumAge: 71 Years maximumAge: 75 Years stdAges: OLDER_ADULT facility: U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova status: RECRUITING city: Padova zip: 35128 country: Italy name: Umberto Cillo, MD role: CONTACT email: [email protected] lat: 45.40797 lon: 11.88586 hasResults: False |
<|newrecord|> nctId: NCT06382727 id: ER008 briefTitle: CONTINUation of Enteral Nutrition Prior to Extubation Compared to Standard Care acronym: CONTINUE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-24 date: 2024-04-24 name: Emma Ridley class: OTHER briefSummary: Critically ill patients admitted to the Intensive Care Unit (ICU) often need to be connected to a breathing machine (ventilator) and are unable to eat. During this time, liquid nutrition is delivered via a feeding tube to the stomach or bowel (termed enteral nutrition (EN)) to ensure nutrition needs are provided until such time that the patient can eat normally. |
The delivery of nutrition via EN is frequently interrupted due to procedures and changes in the gastrointestinal system that can cause digestion to be slow. One of the main contributors to EN interruptions is fasting prior to removal of the breathing tube (termed extubation). |
The practice of pausing EN prior to the removal of the breathing tube is historical and based on evidence for patients who are not within the ICU. There is currently no scientific consensus on whether pausing of EN is necessary, or for how long. Because of this, some clinicians choose to pause EN prior to removal of the breathing tube and some clinicians continue to provide EN. |
This study is a pilot randomised controlled trial of fasting patients for at least 4 hours prior to removal of the breathing tube compared with not pausing EN. The investigators hypothesise that this will reduce the number of hours of fasting in the 24 hours prior to extubation. conditions: Critical Illness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: CONTINUE is a multi-centre, open-label, prospective parallel, pilot randomised controlled trial being conducted in Australia. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 60 type: ESTIMATED name: EN will be continued up to extubation (EN will not be withheld prior to extubation) measure: Fasting time (hours) measure: Reintubation rate measure: Days alive and free of mechanical ventilation measure: Commencement of antibiotics measure: Ratio of oxygen saturation (SpO2)/ fraction of inspired oxygen (FiO2) measure: ICU length of stay measure: In-hospital mortality measure: Nutrition delivery measure: Recruitment rate measure: Protocol compliance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gold Coast University Hospital city: Southport state: Queensland zip: 4215 country: Australia name: James Mccullogh, Dr role: CONTACT lat: -27.96724 lon: 153.39796 facility: St Vincent's Hospital Melbourne city: Fitzroy state: Victoria zip: 3065 country: Australia name: Alastair Brown, Dr role: CONTACT lat: -37.79839 lon: 144.97833 facility: The Alfred Hospital city: Melbourne state: Victoria zip: 3004 country: Australia name: Emma Ridley, A/Prof role: CONTACT name: Sean Keem, Dr role: CONTACT lat: -37.814 lon: 144.96332 hasResults: False |
<|newrecord|> nctId: NCT06382714 id: 2023-12/13 briefTitle: Virtual Museum Visit on Dialysis Symptoms and Anxiety in Hemodialysis Patients overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-08-30 date: 2024-12-31 date: 2024-04-24 date: 2024-04-24 name: Cumhuriyet University class: OTHER briefSummary: The main purpose of dialysis used in the treatment of end-stage renal failure is; By relieving the patient from uremic symptoms, controlling excess fluid, electrolyte and acid base disorders, improving the well-being of the patients and also improving the quality of life of the patients. In addition to its contribution to the continuation of life, dialysis can significantly affect the biological and physiological balance and normal life order of patients. Some of these effects may be negative on patients. During this process, patients may frequently experience symptoms such as changes in fluid-electrolyte balance, increased fatigue, and weakness, as well as psychopathological conditions such as anxiety. In this context, it is extremely important to handle patients from a holistic perspective and keep their homeostatic balance under control during the hemodialysis process. In addition to pharmacological treatments, many integrative methods are used in the management of symptoms for reasons such as being low in cost, having fewer side effects than pharmacological treatments, and strengthening the immune system. Museum visit, one of these integrative treatment methods, has become an area of art therapy where help is received for various reasons such as coping with the symptoms of chronic diseases, reducing the side effects of medications, preventing mental depression, strengthening healthy behaviors, and avoiding tension and loss of control. In this context, the research was planned as a randomized controlled study investigating the effect of virtual museum tour on dialysis symptom index and anxiety in hemodialysis patients..T.R. The "https://sanalmuze.gov.tr" site belonging to the Ministry of Culture and Tourism will be shown to the patients five times and the virtual museum visit will be made by showing the patient's preferred museum five times among the 53 museums prepared by the General Directorate of Information Technologies of the Ministry of Culture and Tourism, and the Initiative Group, Control It will be compared with its group. Research data; It will be collected using the Patient Information Form, Dialysis Symptom Index and Beck Anxiety Scale (BAI). At the end of the study, the data will be evaluated in the SPSS program. The museum visit applied to the Intervention Group will also be applied to the control group after the study is completed, taking into account the ethical dimension. conditions: DIALYSIS SYMPTOMS AND ANXIETY studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: For the intervention group, a museum visit with virtual reality glasses will be applied. measure: Dialysis Symptom Index (DSI) measure: Beck Anxiety Scale (BAI) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mukadder city: Mollaoğlu state: Sivas zip: 58140 country: Turkey name: Mukadder Mollaoğlu, Prof Dr. role: CONTACT phone: 90 5055723985 email: [email protected] name: Songül Mollaoğlu, Assoc Prof role: CONTACT phone: 90 532 480 08 32 email: [email protected] lat: 39.70028 lon: 30.28306 hasResults: False |
<|newrecord|> nctId: NCT06382701 id: Kayseri briefTitle: Effect of Aromatherapy on Pain, Anxiety and Satisfaction in Cannulation overallStatus: ACTIVE_NOT_RECRUITING date: 2021-09-06 date: 2024-06-30 date: 2024-06-30 date: 2024-04-24 date: 2024-04-24 name: TC Erciyes University class: OTHER briefSummary: The most active members of the healthcare professionals responsible for hemodialysis units are nurses, and they have a key role in pain, anxiety and satisfaction management as they are responsible for cannulation. Therefore, complementary and integrated practices need to be implemented based on evidence to strengthen the independent role of nurses in managing pain and anxiety. conditions: Hemodialysis Patients studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study was designed as a randomized controlled and double-blind study to evaluate the effect of clove oil applied to arterio-venous fistula on pain and anxiety caused by cannulation and to determine the effect of the application on satisfaction. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: Pre-cannulation spray application to the intervention and placebo groups will be provided by an interviewer trained by the researchers. Cannulations will be performed by nurses in the institution where the study is conducted. Data will be collected by the responsible nurses in the institutions. |
Patients participating in the study, researchers, and the nurse in charge will not know who is in the intervention and placebo groups. |
The research will be completed in twelve sessions over four weeks. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: aromatherapy name: placebo measure: Visual Analog Scale (VAS) measure: State and Trait Anxiety Inventory (STAI) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erciyes University city: Melikgazi state: Kayseri zip: 38260 country: Turkey hasResults: False |
<|newrecord|> nctId: NCT06382688 id: 23-08-0010 briefTitle: IV Administration of ChromaDex's Niagen® as Compared to NAD+ overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-13 date: 2024-03-08 date: 2024-08-31 date: 2024-04-24 date: 2024-04-24 name: Franklin Health Research class: OTHER briefSummary: This is a 2-part study evaluating the effects of IV administration of NR on healthy adult populations. Study 1 involved all four arms with 37 people. The second study only included the active NR and NAD+ arms to further evaluate tolerability and comfort of the IV. conditions: Healthy Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 53 type: ACTUAL name: NAD+ (nicotinamide adenine dinucleotide) IV name: Niagen® (nicotinamide riboside) IV name: Niagen® (nicotinamide riboside) oral name: Placebo measure: Blood Pressure measure: Heart rate measure: Total NAD measured through dried blood spot testing measure: Glucose measure: Insulin Levels measure: total NAD measured through blood and plasma measure: Tolerable Infusion Rate measure: Complete Blood Count measure: Comprehensive Metabolic Panel measure: Sleep Scale measure: Energy Scale measure: Subjective Experience sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nutraceuticals Research Institute city: Franklin state: Tennessee zip: 37067 country: United States lat: 35.92506 lon: -86.86889 hasResults: False |
<|newrecord|> nctId: NCT06382675 id: TA-PF-01-DE id: CIV-23-11-044643 type: OTHER domain: Unique identification number EUDAMED briefTitle: Clinical Performance of the New Plasma Filter PX2 in TPE Treatments acronym: plasmaFlux overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2025-03 date: 2024-04-24 date: 2024-04-24 name: Fresenius Medical Care Deutschland GmbH class: INDUSTRY name: KLIFO GmbH briefSummary: The plasma filter is applied for a single use in extracorporeal blood purification therapy. The intended purpose is the separation of plasma from blood by filtration, in conditions, which are associated with increased concentration of plasma components where a rapid depletion slows down or stops a pathogenic process. |
The investigation involves the collection of treatment data of the new Plasma Filter PX2 in combination with the multiFiltrate and multiFiltratePRO in therapeutic plasma exchange (TPE) treatments. The multiFiltrate and multiFiltratePRO are devices for extracorporeal blood purification treatments. No further control treatments will be investigated in this one arm design. The design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the new Plasma Filter PX2. No specific treatment schedule is defined by the study protocol. The TPE treatment is performed with the plasma filter PX2 (investigational device) according to clinical practice established in each of the participating centers and are prescribed at the discretion of the treating physician. The participation in the study will have no influence on the treatment plan. The documentation of the treatment includes the therapy up to the tenth (10th) treatment. conditions: Autoimmune Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Interventional, single arm, multi-centric, open-label primaryPurpose: TREATMENT masking: NONE count: 46 type: ESTIMATED name: Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2 measure: Analysis of TPE treatments with the Plama Filter PX2 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Klinikum Aschaffenburg-Alzenau city: Aschaffenburg state: Bavaria zip: 63739 country: Germany name: Stefan Büttner, Dr. med. role: CONTACT email: [email protected] lat: 49.97704 lon: 9.15214 facility: Städtisches Klinikum Braunschweig city: Braunschweig state: Niedersachsen zip: 38126 country: Germany name: Gabriele Eden, Dr. med. role: CONTACT email: [email protected] lat: 52.26594 lon: 10.52673 hasResults: False |
<|newrecord|> nctId: NCT06382662 id: PMDAC-01 briefTitle: Effect of Metaxalone 640 mg (M640) on Truck Driving Ability and Cognition Compared to Other Skeletal Muscle Relaxants overallStatus: RECRUITING date: 2024-04-15 date: 2025-04-15 date: 2025-04-15 date: 2024-04-24 date: 2024-04-26 name: Primus Pharmaceuticals class: INDUSTRY name: Sun Valley Arthritis Center briefSummary: Every participant will receive active study drug and (tone) 1 comparator, in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. There will be (four) 4 visits. conditions: Cognitive Impairment studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This is a prospective, randomized, single-blind, pilot study to assess degree of drowsiness, cognition, and driving risk following a single dose of oral metaxalone 640 mg (M640) versus metaxalone 800 mg in healthy subjects. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: metaxalone m640 name: Tizanidine measure: Change from baseline, Standard Deviation of Lateral Position measure: Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes measure: Change from baseline of participants' subjective report of drowsiness on a 10-point scale measure: Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test) measure: The number of product related adverse events experienced by participants from Visit 1 through Visit 4 sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Valley Arthritis Center status: RECRUITING city: Peoria state: Arizona zip: 85381 country: United States name: Study Investigator role: CONTACT phone: 623-566-3550 email: [email protected] name: Study Coordinator role: CONTACT phone: 623-566-3550 lat: 33.5806 lon: -112.23738 hasResults: False |
<|newrecord|> nctId: NCT06382649 id: 202403051 briefTitle: Rivastigmine for Antimuscarinic Delirium acronym: RIVA-AM overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-07 date: 2026-07 date: 2024-04-24 date: 2024-04-25 name: Washington University School of Medicine class: OTHER name: American Academy of Clinical Toxicology briefSummary: Antimuscarinic delirium (AMD) is a common and dangerous toxicology condition caused by poisoning by medications and other chemicals that block muscarinic receptors. Physostigmine, the standard antidote for AMD, currently has very limited availability in the United States due to an interruption of production. |
Recent case reports and small observational studies suggest that rivastigmine might be useful in the treatment of AMD, but there is not direct prospective evidence comparing rivastigmine to physostigmine or supportive care. In order to investigate the effectiveness of rivastigmine, the investigators propose a randomized, placebo-controlled clinical trial of rivastigmine for AMD. The investigators hypothesize that patients treated with rivastigmine for antimuscarinic delirium will experience more rapid resolution of agitation and delirium than those treated with placebo. conditions: Anticholinergic Toxicity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: Rivastigmine name: Placebo measure: Time to control of agitation and delirium measure: Duration of agitation and delirium measure: Total amount of sedatives administered measure: Use of sedative infusions measure: Use of physical restraints measure: Disposition measure: Time to medical clearance measure: Oversedation measure: Intubation measure: Seizure measure: Gastrointestinal upset measure: Bradycardia sex: ALL minimumAge: 10 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Washington University School of Medicine city: Saint Louis state: Missouri zip: 63110 country: United States name: Kevin Baumgartner role: CONTACT phone: 314-273-1109 email: [email protected] lat: 38.62727 lon: -90.19789 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-04-10 uploadDate: 2024-04-19T15:42 filename: ICF_000.pdf size: 1060713 hasResults: False |
<|newrecord|> nctId: NCT06382636 id: 23-101 briefTitle: Engaging Patients in Prenatal Genetic Testing Decisions as a Pathway to Improve Obstetric Outcomes acronym: OPUS overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2027-02-28 date: 2027-02-28 date: 2024-04-24 date: 2024-04-24 name: The Cleveland Clinic class: OTHER briefSummary: The goal of this study is to ensure that pregnant patients have the resources and support needed to access Prenatal Screening \& Diagnostic Testing (PS\&D) in an informed and evidence-based fashion by developing an innovative digital tool to support patients' decision-making and contributing fundamental knowledge to advance science in a way that promotes patients' access to new prenatal applications of genomic science and technology. Our central hypothesis is that, by focusing on patient engagement as a key driver to improve patient outcomes, the use of an evidence-based artificial-intelligence (AI) powered patient engagement tool will increase patients' ability to seek information and structure a decision-making process that, in turn, increases informed decisions about PS\&D and decreases decisional conflict associated with those decisions. |
Using data from NEST (Ensuring Patients Informed Access to NIPT \[non-invasive prenatal testing\]), the investigators designed the next iteration of NEST, a point-of care shared decision-making tool powered by artificial intelligence (AI) to provide a personalized and dynamic decision support tool: Obstetric Prenatal Genetic Testing Engagement Solution (OPUS). OPUS is an AI-enabled healthcare chatbot (a computer program capable of processing and simulating human conversation) that provides patients with personalized information and decision-making support at different stages of the PS\&D pathway. It functions using a series of questions contained in the NEST with a branching logic sequence of questions and answers based on the responses to and from the patient, using a conversational and adaptable interaction. It also contains nested tiers of information, ranging from introductory to detailed information about patient engagement, health literacy, the different PS\&D options, and resources to learn about insurance coverage for PS\&D. OPUS was designed to be accessed by patients with different technological resources and preferences, using a cell phone, a mobile device, or a computer. conditions: Prenatal Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 600 type: ESTIMATED name: Standard Care name: Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI Chatbot measure: Patient activation sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Neighborhood Family Practice city: Cleveland state: Ohio zip: 44102 country: United States name: Heidi Gullett, MD role: CONTACT phone: 216-368-0776 email: [email protected] lat: 41.4995 lon: -81.69541 facility: MetroHealth Medical Center city: Cleveland state: Ohio zip: 44109 country: United States name: Angela Ranzini, MD role: CONTACT phone: 216-778-3513 email: [email protected] lat: 41.4995 lon: -81.69541 facility: Cleveland Clinic city: Cleveland state: Ohio zip: 44195 country: United States name: Ruth Farrell, MD, MA role: CONTACT phone: 216-445-7085 email: [email protected] name: Christina Collart, MEd role: CONTACT phone: 216-470-9796 email: [email protected] lat: 41.4995 lon: -81.69541 hasResults: False |
<|newrecord|> nctId: NCT06382623 id: 43 briefTitle: Efficacies of Different Managements in Patients With Trigger Finger overallStatus: COMPLETED date: 2022-10-01 date: 2023-06-30 date: 2023-06-30 date: 2024-04-24 date: 2024-04-24 name: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital class: OTHER briefSummary: The aim of the study is to compare the effectiveness of peritendinous steroid injection under ultrasound guidance and percutaneous A1 pulley release procedures in terms of disease stage, pain, and severity of locking in patients with trigger finger. conditions: Trigger Finger studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ACTUAL name: The percutaneous A1 pulley release name: The peritendinous Betamethasone group measure: Stage of the disease measure: Pain intensity measure: severity of triggering sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False |
<|newrecord|> nctId: NCT06382610 id: 2024-002 briefTitle: Pharmacokinetics of Melatonin Administered in Oral, Lotion, and Bubble Bath Formulations overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2024-12-15 date: 2024-12-15 date: 2024-04-24 date: 2024-04-24 name: University of Redlands class: OTHER briefSummary: Melatonin is a hormone that promotes sleep that is available without a prescription in the United States. In addition to oral supplements, melatonin can be purchased in the form of lotions and bubble baths with unknown dosage and no frequency or age recommendations. In this study, researchers will examine how quickly melatonin in lotion and bubble bath is absorbed compared to oral tablets, as well as how long the melatonin lasts in the body. conditions: Sleep studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Repeated measures crossover trial primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ESTIMATED name: Melatonin measure: Salivary melatonin level measure: Side effects sex: ALL minimumAge: 18 Years maximumAge: 22 Years stdAges: ADULT facility: University of Redlands city: Redlands state: California zip: 92373 country: United States lat: 34.05557 lon: -117.18254 hasResults: False |
<|newrecord|> nctId: NCT06382597 id: AWFiS/2024_2_P-GM briefTitle: Four Weeks of Nordic Hamstring Exercises Impact the Strength and Balance of the Hamstring Muscle Group overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-10 date: 2024-07-10 date: 2024-04-24 date: 2024-04-24 name: Gdansk University of Physical Education and Sport class: OTHER briefSummary: The aim of the study is to assess the impact of 4 weeks of eccentric Nordic Hamstring Exercise training on changes in the hamstring muscle group, as well as to analyze parameters such as maximum muscle strength of the knee flexors, RFD (rate of force development) and static balance, dynamics for the dominant leg. conditions: Hamstring Injury studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 2 type: ESTIMATED name: Nordic hamstring exercise measure: Biodex Balance System measure: Biodex System sex: ALL minimumAge: 19 Years maximumAge: 26 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06382584 id: IRB_23.09.01 briefTitle: Impact of Treatment With Oral Anticoagulants of Patients With Fractures of the Upper End of the Femur acronym: ANTI_XA overallStatus: COMPLETED date: 2022-01-01 date: 2023-06-01 date: 2023-06-01 date: 2024-04-24 date: 2024-04-24 name: Centre Hospitalier Universitaire de Nīmes class: OTHER briefSummary: In 2023, oral anticoagulant treatments (anti Xa: apixaban , rivaroxaban, etc.) are tending to replace anti vitamin K treatments in many medical indications. Their prescription is increasing rapidly in the elderly. |
In this context, the Nimes University Hospital receives a large number of elderly patients who have suffered a fracture of the end of the femur requiring surgery and who are taking anti Xa drugs.To avoid massive intra- and post-operative haemorrhage, surgical management is postponed because of the need to suspend the treatment, allowing a return to near-normal biological haemostasis within a few days. No consensus has been reached on the withdrawal period required to authorise surgery, as the elimination kinetics of the drug are altered in this context (elderly patients, dehydration, hypovolaemia, impaired renal function). A plasma assay (threshold of \<30 to 60 ng/mL) has been proposed without any real justification. This waiting period exposes the elderly to excess mortality. Reversing these treatments by adding coagulation factors would be an attractive alternative, as it would allow surgery to be performed earlier, but this would expose patients to an increased thrombotic risk. |
Before considering a prospective randomised study (early vs delayed surgery on AOD), we wish to retrospectively analyse data on patients admitted to the Nimes University Hospital on anti Xa and operated on for fracture of the upper end of the femur between 1 January 2022 and 1 June 2023 conditions: Direct Oral Anticoagulants (DOACs) conditions: Femoral Fractures conditions: Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 610 type: ACTUAL name: Femoral fracture surgery measure: Hospital Mortality measure: Duration of the surgery measure: Transfusion measure: Postoperative comorbidities measure: Hospital stay measure: Anti Xa assay sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: CHU de NIMES city: Nimes zip: 30029 country: France lat: 43.83333 lon: 4.35 hasResults: False |
<|newrecord|> nctId: NCT06382571 id: 026/66 briefTitle: Factors Associated With Sub - Targeted Therapeutic Dose Of Renin - Angiotensin Blockage Among Chronic Heart Failure With Reduced Ejection Fraction Patients overallStatus: COMPLETED date: 2016-01-01 date: 2020-12-31 date: 2021-12-31 date: 2024-04-24 date: 2024-04-24 name: Chulalongkorn University class: OTHER briefSummary: Objective: To analyze factors associated with Thai heart failure with reduced ejection fraction patients who received sub-target doses of Angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor-neprilysin inhibitors (ARNIs), and angiotensin receptor blockers (ARBs). |
Methods: The retrospective cohort study was designed to collect data on Thai heart failure with reduced ejection fraction patients at Out-patient Clinic, Trat Hospital and Phrapokklao Hospital from January 2016 to December 2020. Thirteen factors were analyzed to determine their association with the sub-target group. conditions: Heart Failure With Reduced Ejection Fraction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 396 type: ACTUAL name: Renin-Angiotensin System Inhibitor measure: factors associated with sub - target dose of ACEIs,ARBs,ARNI sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06382558 id: s68470 id: C2M/23/060 type: OTHER_GRANT domain: KU Leuven briefTitle: Validity and Reliability of Sensorimotor Processing Paradigm overallStatus: RECRUITING date: 2024-04-10 date: 2024-12-31 date: 2024-12-31 date: 2024-04-24 date: 2024-04-24 name: KU Leuven class: OTHER briefSummary: Sensorimotor function of the upper limb is often impaired after stroke, even in the chronic phase (minimum 6 months after stroke). Currently, an optimal assessment for sensory processing, one of the most important sensory functions, does not exists. However, our research team has developed a novel assessment paradigm using the KINARM End-Point robot to assess the level of sensory processing of the upper limb. Within a previous study, the investigators examined the validity within 20 chronic stroke patients and 80 age-matched healthy controls by comparing the novel robotic assessment with a set of existing clinical and robotic assessments for the upper limb. The investigators hypothesize that the stroke patients will show a poorer performance on this novel assessment compared to the healthy controls, that the novel assessment will show better correlation coefficients with other sensory tests compared to motor tests, that the novel assessment can differentiate between different motor subgroups of chronic stroke patients, and that the novel assessment shows good test-retest reliability. conditions: Stroke studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: Kinarm: Passive and active discrimination task measure: Kinarm: Arm position matching task measure: Kinarm: Visually guided reaching task measure: Erasmus modified Nottingham sensory assessment measure: Tactile discrimination test measure: Tactile functional object recognition measure: Stereognosis section of the original Nottingham sensory assessment measure: Wrist position sense test measure: Perceptual threshold of touch measure: Fugl-Meyer upper extremity assessment measure: Action research arm test measure: Barthel index measure: Montreal cognitive assessment measure: Star cancellation test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: KU Leuven status: RECRUITING city: Leuven zip: 3001 country: Belgium name: Geert Verheyden, Prof. Dr. role: CONTACT lat: 50.87959 lon: 4.70093 hasResults: False |
<|newrecord|> nctId: NCT06382545 id: Approval number 36.3.22 briefTitle: Post-instrumentation Pain After Use of the Fanta and M3 Pro Gold Systems overallStatus: COMPLETED date: 2021-11-01 date: 2022-06-30 date: 2022-07-30 date: 2024-04-24 date: 2024-04-24 name: Ahram Canadian University class: OTHER briefSummary: Comparing the intensity of post-operative pain following endodontic treatment of posterior teeth with Fanta (Pepsi gold) (FPG) and M3-pro+ Gold (assorted) (MPG) rotary files. conditions: Endodontic Treatment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ACTUAL name: Fanta (Pepsi gold) (FPG) name: M3-pro+ Gold (assorted) (MPG) measure: comparing the intensity of post-instrumentation pain sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Oral and Dental medicine, Ahram Canadian University city: Giza zip: 12573 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False |
<|newrecord|> nctId: NCT06382532 id: AFMMUChina_NSRT briefTitle: Diagnosis of Depressive Disorder Malinger Using the Niacin Skin Response Test (NSRT) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-05-01 date: 2024-04-24 date: 2024-04-24 name: Air Force Military Medical University, China class: OTHER briefSummary: This study will explore the specific response characteristics of the niacin skin response test in the population with depressive disorder malinger. The investigators expect that depressive disorder malinger can be discriminated by the niacin skin reaction test. conditions: Depressive Disorder conditions: Malingering studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 410 type: ESTIMATED name: Niacin skin reaction test measure: Niacin reaction test measure: Model specificity and sensitivity measure: The F Scale in Minnesota Multiphasic Personality Inventory sex: MALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Air Force Medical Center city: Beijing state: Beijing zip: 100142 country: China name: Jin Wang role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06382519 id: Thal in VEOIBD briefTitle: Thalidomide Therapy for VEOIBD overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-12-31 date: 2026-12-31 date: 2024-04-24 date: 2024-04-24 name: Children's Hospital of Fudan University class: OTHER briefSummary: This is a single center, observational study to investigate the clinical outcomes of thalidomide treatment for very early onset inflammatory bowel disease conditions: Inflammatory Bowel Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Thalidomide measure: endoscopic response rate measure: clinical response rate measure: biomarker remission rate measure: growth development measure: clinical remission rate with steroid-free measure: adverse event measure: treatment persistence sex: ALL minimumAge: 28 Days maximumAge: 6 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06382506 id: 2024/138 briefTitle: The Effect of Hazelnut Flour on Blood Glucose acronym: Hazelnut overallStatus: COMPLETED date: 2024-03-21 date: 2024-04-21 date: 2024-04-21 date: 2024-04-24 date: 2024-04-24 name: Ege University class: OTHER briefSummary: One of the factors affecting human health is nutrition. The effects of foods on blood glucose are still under investigation. The Glycemic Index (GI), which is associated with many diseases today, is a value that measures the rate at which carbohydrate-containing foods raise blood glucose. It is thought that the loaves of bread produced will be a product with low GI value and can be consumed by celiacs and diabetics. It is aimed to investigate the effect of adding different amounts of hazelnut flour to bread recipes using gluten-free corn flour on blood glucose. conditions: Obesity conditions: Celiac Disease conditions: Blood Glucose conditions: Flour Sensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 24 type: ACTUAL name: Consumption of Cornbread with Hazelnut Bread measure: One loaf of bread was consumed each week and the study will continue for a month. Blood glucose measurements were performed with a glucometer at 0 (fasting), 15, 30, 45, 60, 90, and 120 minutes after each bread consumption. measure: This classification as obese and normal-weight individuals was made with the BIA (Bioelectrical impedance analysis) method. This classification was understood by anthropometric measurements made in the first week. sex: FEMALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Avrasya University city: Trabzon zip: 61000 country: Turkey lat: 41.005 lon: 39.72694 hasResults: False |
<|newrecord|> nctId: NCT06382493 id: B-2011-648-005 briefTitle: Tegoprazan-containing Sequential for H. Pylori overallStatus: RECRUITING date: 2021-02-01 date: 2024-12-12 date: 2024-12-12 date: 2024-04-24 date: 2024-04-24 name: Seoul National University Bundang Hospital class: OTHER briefSummary: As H. pylori eradication, we prepared a randomized controlled clinical trial whether tegoprazan-containing 10-day sequential treatment was effective compared to conventional PPI-containing 10-day sequential eradication therapy conditions: Helicobacter Pylori Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 400 type: ESTIMATED name: Tegoprazan-containing sequential H. pylori eradication therapy measure: Eradication rate measure: Adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Bundang Hospital status: RECRUITING city: Seongnam-si state: Gyeonggi-do zip: 463-707 country: Korea, Republic of name: Nayoung Kim, M.D.,Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 37.43861 lon: 127.13778 hasResults: False |
<|newrecord|> nctId: NCT06382480 id: 90/2023 briefTitle: PROTeIn-rich Meals to Control Glucose acronym: PROTIME overallStatus: RECRUITING date: 2024-04-12 date: 2026-12-31 date: 2027-02-28 date: 2024-04-24 date: 2024-04-24 name: German Institute of Human Nutrition class: OTHER name: Charite University, Berlin, Germany name: Helmholtz Center Munich name: Hasso Plattner Institute, Potsdam, Germany briefSummary: The overall aim is to identify the dietary pattern for prevention and treatment of type 2 diabetes. The specific aim of this pilot project is to compare effects of two diets with different diurnal distribution of carbohydrates and protein on the glucose metabolism in subjects with prediabetes and type 2 diabetes and its effects on inflammatory status. conditions: Overweight conditions: Obesity conditions: Prediabetes conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The trial will have a cross-over design and compare metabolic effects of two isocaloric 4-week interventions with opposite timely distribution of macronutrient intake divided by a 4-week wash-out phase. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: Diet with specific macronutrient composition. measure: Mean 24-hour glucose measure: Measurement of height measure: Measurement of body weight measure: Waist and hip circumference / waist to hip ratio measure: Systolic and diastolic blood pressure measure: Body fat and lean mass measure: Energy expenditure and substrate oxidation rates measure: Hepatic values (gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT)) measure: Renal values (creatinine, urea, uric acid) measure: Intra- und inter-day glycemic variability measure: Glucose levels in meal tolerance test (MTT) measure: Metabolic hormones (insulin, C-peptide, glucagon, glucagon-like peptite 1(GLP-1), gastric inhibitory polypeptide (GIP), peptide YY (PYY), ghrelin, adiponectin, leptin) measure: Inflammatory markers and T cell populations analyses measure: Satiety and hunger scores measure: Sleep/wake timing and sleep quality measure: Physical activity measure: Adipose tissue transcriptome measure: Gene expression in peripheral blood mononuclear cells (PBMC) measure: Gut microbiota and microbiome-derived metabolites measure: Determination of decision behavior sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Olga Ramich status: RECRUITING city: Potsdam state: Potsdam-Rehbrücke zip: 14558 country: Germany name: Olga Ramich, PD Dr. role: CONTACT phone: +4933200882749 email: [email protected] name: Marina D'Urso role: CONTACT phone: +4933200882690 email: [email protected] lat: 52.39886 lon: 13.06566 hasResults: False |
<|newrecord|> nctId: NCT06382467 id: 2401-136-016 briefTitle: Comparison of Remimazolam and Propofol Combination vs. Propofol in IOM overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-06 date: 2024-04-24 date: 2024-04-24 name: Chung-Ang University Gwangmyeong Hospital class: OTHER briefSummary: This study aims to compare total intravenous anesthetic agents: combined remimazolam and propofol vs. propofol monotherapy. The comparison parameters are intraoperative hypotension, patient's involuntary movement, neurophysiological monitoring quality, onset time, recovery time, and postoperative rescue anti-emetics requirements. conditions: Neurologic Disorder studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 56 type: ESTIMATED name: Remimazolam besylate + propofol MCT name: Propofol MCT measure: Incidence of intraoperative hypotension measure: Amount and number of inotropic agents measure: Incidence of participants' intraoperative involuntary movement measure: scores of neurophysiologic monitoring quality measure: onset time of study drugs measure: The administration number of rescue anti-emetic agents measure: Time-weighted average of intraoperative hypotension measure: recovery time of study drugs (remimazolam+propofol or propofol) sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06382454 id: E2-23-5921 briefTitle: Upper Extremity Robot-Assisted Therapy in Stroke Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2025-03-30 date: 2025-03-30 date: 2024-04-24 date: 2024-04-24 name: Hacettepe University class: OTHER name: Interact Medical Technologies Inc. briefSummary: Upper extremity hemiparesis is one of the most common symptoms after stroke. Robot-assisted therapies have been used as an approach to rehabilitation of upper extremity hemiplegia in recent years. Robot-assisted therapy is an approach to post-stroke rehabilitation that uses robotic devices to provide motor or task-oriented training to patients. When the literature is examined, there are studies showing that robot-assisted therapies are similar or superior to conventional methods. In order to provide the most effective rehabilitation approach in upper extremity robots, it is suggested that it may be more accurate to consider the robotic device as a training platform consisting of various therapeutic techniques and principles, not as a tool alone. A robotic system will be used to overcome the disadvantages of the existing robotic systems in the literature such as not providing support to the patient at the time of need, not providing fluidity in shoulder movements by not taking into account the scapulohumeral rhythm in upper extremity movements, long installation times, and ignoring task-oriented training. The system to be used is a self-aligning exoskeleton system for robot-assisted upper extremity rehabilitation. The system provides safe and versatile rehabilitation at increasing intensity and also allows for objective assessments. The aim of this clinical study was to evaluate the efficacy of robot-assisted upper limb rehabilitation in stroke patients. conditions: Stroke conditions: Upper Extremity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Assist-On Arm Robot Group name: Control Group measure: Modified Ashworth Scale measure: Fugl-Meyer Assessment Upper Extremity measure: Action Research Arm Test measure: Box and Block Test measure: Nine Hole Peg Test measure: ACTIVLIM measure: ABILHAND Assessment measure: Stroke Impact Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation city: Ankara state: Altındağ, Ankara zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False |
<|newrecord|> nctId: NCT06382441 id: KC/KE-23-0122/ER-4 briefTitle: A Tele-exercise Program for Breast Cancer Survivors overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-01 date: 2024-05-31 date: 2024-05-31 date: 2024-04-24 date: 2024-04-24 name: Hong Kong Baptist University class: OTHER briefSummary: The research protocol outlines a pilot study for a home-based and group-based tele-exercise program designed for breast cancer survivors. The study is a randomized controlled trial (RCT) led by Dr. Yang Gao from Hong Kong Baptist University, with multiple other investigators from Kwong Wah Hospital and the university itself. |
Breast cancer is identified as the most prevalent cancer among women globally and in Hong Kong. The document states that adjuvant therapies post-surgery, such as radiation and chemotherapy, can have both short-term and long-term side effects, which may affect the survivors' physical and mental health. |
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