Datasets:
hackint0sh
/
Text-Clinical-Records

Dataset card Data Studio Files Community
text
stringlengths
0
197k
<|newrecord|> nctId: NCT06267768 id: REC Reference No.:HE-OT2023/13 id: Proj.Ref.No.: 2023/3007-R7052 type: OTHER_GRANT domain: Research Donation Fund, Hong Kong Metropolitan University briefTitle: The Effects of Inspiratory Pressures on Diaphragmatic Contraction in People After Stroke overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-11-30 date: 2025-11-30 date: 2024-02-20 date: 2024-03-27 name: Hong Kong Metropolitan University class: OTHER name: Shenzhen Second People's Hospital briefSummary: This is a cross-sectional study to determine the optimal inspiratory muscle training (IMT) intensity for stroke survivors. Participants will breathe through a pressure threshold inspiratory loading device with varying loads in random order. Each IMT intensity protocol consists of 10 breaths. During the test, accessory inspiratory muscle activity will be measured with surface electromyography (sEMG) and diaphragm thickness will be used to assessed with ultrasonography. Repeated-measures ANOVA will be used for statistical analysis to determine the most effective training intensity for future study. conditions: Stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 130 type: ESTIMATED name: Various intensities of inspiratory muscle training measure: Diaphragmatic thickening fraction measure: Muscle activation of the sternocleidomastoid muscle measure: Perceived Exertion Borg scale sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-29 uploadDate: 2024-01-08T21:03 filename: Prot_SAP_000.pdf size: 563906 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-29 uploadDate: 2024-02-15T09:59 filename: ICF_001.pdf size: 197199 hasResults: False
<|newrecord|> nctId: NCT06267755 id: P.T.REC/012/004884 briefTitle: Efficacy of Extracorporeal Shockwave Therapy on Ultrasonography Changes of Upper Trapezius Myofascial Trigger Points in Patients With Non Specific Neck Pain acronym: MTP overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2024-08-30 date: 2024-08-30 date: 2024-02-20 date: 2024-02-20 name: Cairo University class: OTHER briefSummary: this study will be conducted to investigate the effect of Extracorporeal Shockwave Therapy on Ultrasonography Changes of Upper Trapezius Myofascial Trigger Points in Patients With Non Specific Neck Pain conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: extracorporeal shockwave and traditional therapy primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: opaque sealed envelope whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Extracorporeal Shockwave therapy name: Traditional physical therapy measure: muscle thickness measure: hypoechoic area intensity measure: neck disability measure: pressure pain threshold measure: cervical range of motion measure: pain intensity sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06267742 id: CHN097 briefTitle: Clinical Trial to Evaluate MDW for Early Detection of Sepsis overallStatus: RECRUITING date: 2022-06-23 date: 2024-03-31 date: 2024-09-30 date: 2024-02-20 date: 2024-02-28 name: Beckman Coulter, Inc. class: INDUSTRY name: Peking Union Medical College Hospital name: West China Hospital name: Second Affiliated Hospital, School of Medicine, Zhejiang University briefSummary: This study is intended to clinically verify Monocyte Distribution Width (MDW) parameter of DxH 900 Hematology Analyzer for use in early detection and risk assessment of sepsis, severe sepsis, and septic shock in critically ill patients in Emergency Department (ED). This study is also aimed to provide study supporting data for the product to be marketed in China. conditions: Sepsis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2200 type: ESTIMATED name: Complete Blood Count (CBC) with Differential measure: sensitivity, specificity sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing country: China name: Huadong Zhu, MD role: CONTACT lat: 39.9075 lon: 116.39723 facility: West China Hospital, Sichuan University status: RECRUITING city: Chengdu country: China name: Yaxiong Zhou, MD role: CONTACT lat: 30.66667 lon: 104.06667 facility: The Second Affiliated Hospital of Zhejiang University School of Medicine status: RECRUITING city: Hangzhou country: China name: Mao Zhang, MD role: CONTACT lat: 30.29365 lon: 120.16142 hasResults: False
<|newrecord|> nctId: NCT06267729 id: D9660C00001 briefTitle: Study of AZD0754 in Participants With Metastatic Prostate Cancer acronym: APOLLO overallStatus: RECRUITING date: 2024-03-12 date: 2027-05-24 date: 2027-05-24 date: 2024-02-20 date: 2024-04-29 name: AstraZeneca class: INDUSTRY briefSummary: The purpose of this study is to evaluate the safety, tolerability, and antitumour activity of AZD0754 CAR T-cell therapy in participants with metastatic prostate cancer. conditions: Metastatic Prostate Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE maskingDescription: Open-Label count: 60 type: ESTIMATED name: AZD0754 measure: Incidence of participants with Dose-limiting Toxicity (DLTs)/DLT-like events, Adverse Events (AEs), including Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs). measure: Presence of replication-competent lentivirus (RCL) in peripheral blood samples measure: Prostate-specific antigen (PSA) response rate - PSA50 measure: PSA response rate - PSA90 measure: Duration of PSA Response (DoPSA50, DoPSA90) measure: Durable PSA Response Rate (DRRPSA50, DRRPSA90) measure: Time to PSA Response (TTPSA50, TTPSA90) measure: Time to PSA Progression (TTPSAP50, TTPSAP90) measure: Best Overall Response (BOR) measure: Objective Response Rate (ORR) measure: Time to Response (TTR) measure: Duration of Response (DoR) measure: Durable Response Rate (DRR) measure: Disease Control Rate (DCR) measure: Percentage change in tumor size measure: Radiographic Progression-free Survival (rPFS) measure: Overall Survival (OS) measure: Time from AZD0754 Infusion to the first Symptomatic Skeletal-related Events (SSRE) measure: Pharmacokinetics - maximum observed serum concentration (Cmax) of AZD0754 measure: Pharmacokinetics - time taken to reach maximum serum concentration (Tmax) of AZD0754 measure: Pharmacokinetics - Last measurable serum concentration (Clast) of AZD0754 measure: Pharmacokinetics - time of last measurable serum concentration (Tlast) of AZD0754 measure: Pharmacokinetics - Exposure of AZD0754 measure: Biomarker - STEAP2 expression in Tumor sex: MALE minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: RECRUITING city: Duarte state: California zip: 91010 country: United States lat: 34.13945 lon: -117.97729 facility: Research Site status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33612 country: United States lat: 27.94752 lon: -82.45843 facility: Research Site status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30322 country: United States lat: 33.749 lon: -84.38798 facility: Research Site status: RECRUITING city: Hackensack state: New Jersey zip: 07601 country: United States lat: 40.88593 lon: -74.04347 facility: Research Site status: NOT_YET_RECRUITING city: New York state: New York zip: 10065 country: United States lat: 40.71427 lon: -74.00597 facility: Research Site status: NOT_YET_RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States lat: 39.95233 lon: -75.16379 facility: Research Site status: RECRUITING city: Houston state: Texas zip: 77030 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: RECRUITING city: East Melbourne zip: 3002 country: Australia lat: -37.81667 lon: 144.9879 hasResults: False
<|newrecord|> nctId: NCT06267716 id: 274-2023 briefTitle: Pericapsular Nerve Block and Iliopsoas Fascial Plane Block in Hip Surgery overallStatus: RECRUITING date: 2024-02-23 date: 2024-07-30 date: 2024-08-30 date: 2024-02-20 date: 2024-02-28 name: Haseki Training and Research Hospital class: OTHER briefSummary: This prospective randomized interventional study aims to compare the effects of two peripheral nerve blocks, the periencapsular nerve block (PENG) and iliopsoas block (IPB), on analgesia and motor function after hip surgery.
The main questions it aims to answer are the effectivity of postoperative pain management the preservation of motor movement.
Participants will receive standardized general anesthesia and postoperative PENG or IPB in either Group.
Researchers will compare the total amount of rescue analgesia and numeric rating scale with accompanying evaluating motor function at the same time intervals within 24 hour. conditions: Hip Fractures conditions: Peripheral Nerve Block studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: prospective randomized standardized triple-blind primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The participants under general anaesthesia and the orthopaedic surgeon responsible for the study will be blinded to the study groups and the specific block procedures. This surgeon will serve as the sole evaluator of postoperative outcomes. Intraoperative results will be recorded by the anaesthesia technician, who is present in the operating room and unaware of the block procedures. Moreover, the data analysis will be conducted before the data are unblinded. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: PENG block name: IPB measure: postoperative motor block measure: pain scores measure: total analgesia, intraoperative measure: total rescue analgesia sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Haseki Training and Research Hospital status: RECRUITING city: Istanbul state: Sultangazi zip: 34000 country: Turkey name: Berna Caliskan role: CONTACT phone: +905067108770 email: caliskan.b@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False
<|newrecord|> nctId: NCT06267703 id: 2023-01939_VR briefTitle: Multi-omics Analyses on Etiology and Early Detection of Stomach Cancer Precursor Lesions overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2026-12-31 date: 2026-12-31 date: 2024-02-20 date: 2024-02-21 name: Karolinska Institutet class: OTHER briefSummary: The overall aim is to utilize multi-omics approach to identify novel etiopathogenesis and early detection biomarkers for stomach cancer precursor lesions. To achieve this aim, first the investigators will use stored serum samples to perform metabolomics profiling among 12,599 twin subjects, among whom 1034 were deemed to have chronic atrophic gastritis based on measured pepsinogen I and II levels. Logistic regression will be used to search for metabolites related to the risk of chronic atrophic gastritis. Second, the investigators will further measure serum proteome by using two quantitatively precise proteomics assays, among the above-mentioned twin subjects. Identified protein biomarkers will be combined with metabolomics biomarkers to create a prediction model for chronic atrophic gastritis. The results will hopefully improve our understanding of the etiological factors and provide promising early detection biomarkers for stomach cancer precursor lesions. conditions: Chronic Atrophic Gastritis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 12599 type: ACTUAL name: Metabolomic profiling measure: Chronic atrophic gastritis sex: ALL minimumAge: 46 Years maximumAge: 97 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karolinska Institutet city: Solna state: Stockholm zip: 17165 country: Sweden lat: 59.36004 lon: 18.00086 hasResults: False
<|newrecord|> nctId: NCT06267690 id: SYSUFAH2021025 briefTitle: A CT-based Radiomics Model to Predict Survival-graded Fibrosis in PDAC overallStatus: COMPLETED date: 2021-01-13 date: 2023-08-31 date: 2023-08-31 date: 2024-02-20 date: 2024-02-20 name: First Affiliated Hospital, Sun Yat-Sen University class: OTHER briefSummary: Tumor fibrosis plays an important role in chemotherapy resistance in pancreatic ductal adenocarcinoma (PDAC), however there remains a contradiction in the prognostic value of fibrosis. We aimed to investigate the relationship between tumor fibrosis and survival in patients with PDAC, classify patients into high- and low-fibrosis groups, and develop and validate a CT-based radiomics model to non-invasively predict fibrosis before treatment. conditions: Pancreatic Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 295 type: ACTUAL name: surgery measure: fibrosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shi Siya city: Guangzhou state: Guangdong zip: 510000 country: China lat: 23.11667 lon: 113.25 hasResults: False
<|newrecord|> nctId: NCT06267677 id: 2007/3928 briefTitle: Efficacy of Liquid Versus Powder Protein Supplementation to Optimize Protein Intake After Bariatric Surgery overallStatus: COMPLETED date: 2008-01-02 date: 2008-04-18 date: 2009-03-06 date: 2024-02-20 date: 2024-02-20 name: Hospital Clinic of Barcelona class: OTHER briefSummary: The goal of this randomized control trial is to compare the effect of a liquid formula rich in nutrients and low in calories (supplement) with the progressive diet with conventional foods that we usually recommend in patients after surgery. The main question it aims to answer is if the addition of a high-protein, volume-controlled nutritional supplement as a fundamental part of the diet during the first two months after surgery will preserve the patient's nutritional status and prevent the appearance of nutritional deficits and associated complications.
Participants will be evaluated at the beginning, at 1 month and at the end of the study (2m) and the following determinations will be made:
* Analytical determination
* Nitrogen balance by determining urea N2 in 24-hour urine
* Anthropometric determinations
* Body composition determined by impedanciometry
* Resting energy expenditure and nutrient oxidation measured by indirect calorimetry.
* Energy, protein and hydration intake.
* Gastrointestinal tolerance through self-registration of symptoms. Researchers will compare the effect of a complete hypocaloric liquid formula group with the usual progressive diet group to see if they achieve the protein intake goal established for patients after obesity surgery, preservation of nutritional status and lean mass during the rapid phase of weight loss and the gastrointestinal tolerance during the first two months after surgery. conditions: Body Composition conditions: Obesity conditions: Protein Supplementation conditions: Bariatric Surgery Candidate conditions: Weight Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ACTUAL name: High protein liquid formula measure: protein intake measure: evaluate nutritional deficiencies measure: Tolerance sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06267664 id: PI-GR-23-3263 briefTitle: Real-world Effectiveness and Tolerability of Triptans-Ditans-Gepants (TRIDIGEP) acronym: TRIDIGEP overallStatus: RECRUITING date: 2023-12-04 date: 2024-09-30 date: 2024-12-01 date: 2024-02-20 date: 2024-02-21 name: Hospital Clínico Universitario de Valladolid class: OTHER briefSummary: Migraine is the third most prevalent disease and the leading reason of years lived with disability in the most productive years of the life. Migraine associated disability can be alleviated by acute and preventive treatment. The migraine landscape has changed recently, with the approval of novel acute treatments, including oral Calcitonin gene-related peptide antagonists, the gepants (Rimegepant, Ubrogepant, Zavegepant) and 5-HT-1F antagonists, the Ditans (Lasmiditan). These have joined Triptans as acute "migraine-specific" drugs.
The TRIDIGEP study will be an open-label, multiple attack, prospective cohort study.
This study aims to describe 1) the effectiveness of the acute treatments of migraine attacks in routine clinical practice, 2) the tolerability of the drugs, and 3) to explore potential response and tolerability predictors.
The endpoints recommended by the International Headache Society will be employed, including: 1) Pain freedom; 2) Absence of the most bothersome symptom; 3) Sustained pain freedom; 4) Total freedom from migraine; 5) Headache relief; 6) Duration of attacks; 7) Time lost due to an attack; 8) Need of rescue medication. The study endpoints will be assessed at 2, 8 and 24 hours after the acute drug use. Data will be collected by the patients themselves, with a validated data collection instrument within a RedCap questionnaire, using QR codes. conditions: Migraine conditions: Migraine Disorders conditions: Migraine With Aura conditions: Headache Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1500 type: ESTIMATED name: Patients with migraine treated with triptans, Lasmiditan or Gepants measure: Pain freedom at 2 hours measure: Absence of the most bothersome symptom measure: Pain freedom at 8 hours measure: Pain freedom at 24 hours measure: Sustained pain freedom measure: Total freedom from migraine at 2 hours measure: Total freedom from migraine at 8 hours measure: Total freedom from migraine at 24 hours measure: Headache relief at 2 hours measure: Headache relief at 8 hours measure: Headache relief at 24 hours measure: Time to meaningful relief measure: Time to pain freedom measure: Time to migraine freedom measure: Need of rescue medication at 2 hours measure: Need of rescue medication at 8 hours measure: Need of rescue medication at 24 hours measure: Tolerability of the drugs measure: Response predictors at 2 hours measure: Response predictors at 24 hours measure: Tolerability predictors measure: Time lost due to an attack sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clínico Universitario de Valladolid status: RECRUITING city: Valladolid zip: 47010 country: Spain name: David Garcia Azorin, MD, PhD role: CONTACT phone: +34665872228 email: davilink@hotmail.com name: Yesica González Osorio role: CONTACT phone: 634330426 email: yesgonzalezosorio@outlook.com lat: 41.65518 lon: -4.72372 hasResults: False
<|newrecord|> nctId: NCT06267651 id: Steroid in ulcerative colitis briefTitle: Value Of ACE Index (Albumin, CRP And Endoscopy) In Predicting Intra Venous Steroid Response In Acute Severe Ulcerative Colitis In Assiut University Hospitals overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2026-06 date: 2027-01 date: 2024-02-20 date: 2024-02-20 name: Assiut University class: OTHER briefSummary: 1. Determine if the ACE index can predict resoponse to I V steroid in Acute severe ulcerative colitis
2. identify on admission a high-risk population who may beneft from earlier second line medical treatment or surgical intervention. ( steroid non responder groups ) conditions: Early Detection of Complication of Ulcerative Colitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 95 type: ESTIMATED measure: Early prevention of complication of ulcerative colitis sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06267638 id: Chomthong hospital, Thailand briefTitle: Comparison of Postoperative Pain Score Between Perioperative Intravenous Ketamine and Placebo in Patients Undergoing Unilateral Total Knee Arthroplasty Under General Anesthesia overallStatus: RECRUITING date: 2024-01-22 date: 2025-12-31 date: 2025-12-31 date: 2024-02-20 date: 2024-03-12 name: Ministry of Health, Thailand class: OTHER_GOV briefSummary: The goal of this clinical trial is to compare postoperative pain score between perioperative intravenous ketamine and placebo in patients undergoing unilateral total knee arthroplasty under general anesthesia. The main question\[s\] it aims to answer are:
* Can perioperative intravenous ketamine reduce postoperative pain score during rest and movement at 0, 2, 4, 8, 12, 18, 24 hours better than no administration of Ketamine in patients undergoing Unilateral total knee arthroplasty under general anesthesia?
* Can perioperative intravenous ketamine reduce morphine consumption in postoperative 24 hours, length of hospital stay, first time to receive opioid and side effect or complication from ketamine and opioid better than no administration of Ketamine in patients undergoing Unilateral total knee arthroplasty under general anesthesia? Participants will receive intravenous ketamine intraoperative TKA and comparison group will receive placebo that is normal saline. Researchers will compare perioperative intravenous ketamine and placebo to see postoperative pain score, morphine consumption in postoperative 24 hours, length of hospital stay, first time to receive opioid and side effect or complication from ketamine and opioid. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Ketamine group name: Placebo group measure: Postoperative pain score at rest and movement measure: First time to receive intravenous analgesic drug measure: Morphine consumption measure: Length of hospital stay measure: side effect and complication from ketamine and opioid sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chomthong hospital status: RECRUITING city: Chiangmai zip: 50160 country: Thailand name: Numphung Sukantarat, master role: CONTACT phone: 66855426519 email: phuang_007@yahoo.com lat: 18.79038 lon: 98.98468 hasResults: False
<|newrecord|> nctId: NCT06267625 id: Elderly Individuals briefTitle: Physical Impairments in Elderly Individuals overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-03-15 date: 2026-12-15 date: 2024-02-20 date: 2024-02-20 name: Izmir Democracy University class: OTHER briefSummary: There are no studies in the literature reporting the dyspnea, posture, strength, physical activity, functional mobility and balance in elderly individuals. The aims of this observational study are; 1) to evaluate dyspnea, posture, strength, physical activity, functional mobility and balance in elderly individuals, 2) to reveal the relationships between these parameters of research group. conditions: Aging Disorder studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: Physical Evaluations of individuals measure: Dyspnea score measure: Posture score measure: Cough strength measure: Handgrip strength measure: Functional mobility score measure: Physical activity score measure: Functional Mobility score measure: Balance score measure: Cognitive function score sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Izmir Democracy University city: İzmir zip: 35140 country: Turkey name: GÜLŞAH BARĞI, Assoc.Dr. role: CONTACT phone: +90 531 793 8766 email: gulsahbargi35@gmail.com name: ESRA SUDE AKIN, BSc role: CONTACT phone: +90 543 581 4690 email: esrasudeakin@gmail.com lat: 38.41273 lon: 27.13838 hasResults: False
<|newrecord|> nctId: NCT06267612 id: KY20231109-11 briefTitle: Corheart 6 LVAS Long-term Follow-up Study overallStatus: NOT_YET_RECRUITING date: 2024-02-10 date: 2030-06-30 date: 2030-06-30 date: 2024-02-20 date: 2024-02-20 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: The purpose of this clinical study is to explore the long-term efficacy and safety of the Corheart 6 Left Ventricular Assist System (LVAS) as a treatment for patients with advanced heart failure.
The study will be a single-arm, prospective, single-center, non-blinded, and non-randomized study with a follow-up duration of five years. conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Corheart 6 Left Ventricular Assist System measure: Device implantaion success rate at 24 months post-implantation measure: Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) measure: Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L) questionnaire measure: Functional status as measured by the Six Minute Walk Test (6MWT) measure: Functional status as measured by the New York Heart Association (NYHA) Classification measure: Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score measure: Stroke severity as assessed by the modified Rankin Scale (mRS) score measure: Adverse events measure: Device-related re-operations measure: Device-related re-hospitalizations measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing First Hospital city: Nanjing state: Jiangsu country: China name: Zhibing Qiu role: CONTACT email: qiuzhibing2009@163.com lat: 32.06167 lon: 118.77778 hasResults: False
<|newrecord|> nctId: NCT06267599 id: ACAR-Style Bladder Suture briefTitle: Bladder Suture in Uterus-Sparing Surgery and Hysterectomy for Placenta Percreta overallStatus: COMPLETED date: 2023-09-01 date: 2023-12-01 date: 2024-01-01 date: 2024-02-20 date: 2024-02-20 name: Necmettin Erbakan University class: OTHER briefSummary: This study aimed to evaluate the short-term and long-term complications of placenta percreta with bladder invasion. This evaluation focuses on cases where bladder dissection and ACAR-style bladder sutures were applied in cases of placenta percreta with bladder invasion that underwent uterine-sparing surgery or hysterectomy. conditions: Placenta Percreta conditions: Bladder Injury conditions: Sutures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 81 type: ACTUAL name: ACAR-Style Bladder Suture measure: Comparison of intraoperative bleeding and complication rates of the two groups measure: Comparison of postoperative bleeding between two groups measure: Comparison of complication rate between two groups sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Cemre Alan city: Konya country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
<|newrecord|> nctId: NCT06267586 id: PN23.007 briefTitle: Effects of PeptiSleep in Healthy Males and Females With Mild to Moderate Sleep Impairment overallStatus: RECRUITING date: 2024-04-08 date: 2024-12-30 date: 2025-02-20 date: 2024-02-20 date: 2024-04-24 name: Nuritas Ltd class: INDUSTRY name: RDC Clinical Pty Ltd briefSummary: Examining the effects of PeptiSleep, a plant-based sleep aid, in healthy males and females with mild to moderate sleep impairment conditions: Sleep studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, single-blind, placebo-controlled, parallel dose response study conducted over 70 days primaryPurpose: OTHER masking: SINGLE maskingDescription: Participants will be unaware of arm allocation however as each arm contains a different number of capsules to be consumed, the investigator will be aware of the arm allocation whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: PeptiSleep name: Placebo MCC micro-crystalline cellulose measure: Safety and Tolerability of a dose range of PeptiSleep via adverse event reporting measure: Safety via electrolytes and liver function tests measure: Sleep Quality via Leeds Sleep Evaluation Questionnaire measure: Insomnia severity via the Insomnia Severity Index Questionnaire measure: Sleep onset time via self-reported recording in a Sleep Diary measure: Sleep pattern via self-reported recording in a Sleep Diary measure: Daytime Sleepiness via the Epworth Sleepiness Scale measure: Stress via the Perceived Stress Scale measure: Stress via self reported Profile of Mood States Questionnaire measure: Anxiety via self-reported Beck Anxiety Inventory questionnaire measure: Stress via Salivary cortisol test measure: Alertness via Reaction Time Test measure: Circadian cycles via melatonin and serotonin via blood test measure: Markers associated with inflammation via blood test measure: Sleep onset latency via wearable sleep tracker measure: Total sleep time spent in sleep phases via wearable sleep tracker measure: Blood pressure via blood pressure machine measure: Heart rate via blood pressure machine measure: Body Temperature via wearable sleep tracker measure: BMI via height and weight measurements measure: Bedtime via wearable sleep tracker measure: Total time awake via wearable sleep tracker measure: Sleep quantity via wearable sleep tracker measure: Sleep efficiency via wearable sleep tracker measure: Sleep score via wearable sleep tracker measure: Nocturnal heart rate via wearable sleep tracker measure: Heart Rate variability via wearable sleep tracker measure: Blood Oxygen sensing via sleep tracker measure: Respiratory rate via sleep tracker measure: Daily Readiness Score via sleep tracker sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RDC Clinical status: RECRUITING city: Brisbane state: Fortitude Valley Queensland zip: 4006 country: Australia name: Amanda Rao role: CONTACT name: Amanda Rao role: PRINCIPAL_INVESTIGATOR lat: -27.46794 lon: 153.02809 hasResults: False
<|newrecord|> nctId: NCT06267573 id: Kerolos protocol briefTitle: Thoracoabdominal Aortic Aneurysms overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-09-15 date: 2026-09-10 date: 2024-02-20 date: 2024-02-20 name: Assiut University class: OTHER briefSummary: Evaluation of the effectiveness of the different modalities for treatment of thoracoabdominal aortic aneurysms. FEVAR and BEVAR devices are widely used now due to its feasability and wide range of use . We aim to evaluate the effectiveness of these new devices in the management of TAAA conditions: Thoracoabdominal Aortic Aneurysm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Fenestrated and branched endovascular devices for TAAA measure: Successful cannulation of the target vessels with complete in-line flow to target organs. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06267560 id: CTQJ230A12303 briefTitle: Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD overallStatus: NOT_YET_RECRUITING date: 2024-05-27 date: 2027-06-21 date: 2027-06-21 date: 2024-02-20 date: 2024-02-20 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c. QM in US Black/African American and Hispanic participants with established ASCVD and elevated levels of Lp(a) who are treated for cardiovascular (CV) risk factors according to local practice/guidelines for the reduction of cardiovascular risk. conditions: Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Eligible participants will be randomized after the screening period or Guideline recommended SOC implementation period (if needed) in a 2:1 ratio to subcutaneous injections of pelacarsen (TQJ230) 80 mg QM or placebo QM either to be self-administered or administered by caregiver or site personnel approximately every 30 days for up to 12 months. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 400 type: ESTIMATED name: TQJ230 name: Placebo measure: Change in log-transformed Lp(a) concentration from baseline at week 52 measure: Incidence proportion of study discontinuations due to TEAEs measure: Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06267547 id: 2023P003522 briefTitle: Healthy Activities Improve Lives (HAIL) acronym: HAIL overallStatus: RECRUITING date: 2024-04-23 date: 2026-12-01 date: 2027-02-01 date: 2024-02-20 date: 2024-04-29 name: Massachusetts General Hospital class: OTHER name: National Institute on Aging (NIA) briefSummary: The investigators have developed an online platform to support the 8-week, F\&S! exercise program called the Healthy Activity Improves Lives (HAIL) online platform. The aim of this study is to perform a cluster randomization of four racially diverse churches or senior centers to either the standard F\&S! program, or the combined HAIL Online Platform + F\&S! program to examine the efficacy of the HAIL online platform + F\&S! program for older adults in black communities. conditions: Physical Activity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: HAIL Online Platform name: Fit and Strong! Program measure: Feasibility and Retention measure: Acceptability measure: Acceptability (Feedback Form) measure: Acceptability (Exit Interviews) measure: Changes in Physical Activity (Steps) measure: Changes in Physical Activity (MVPA) measure: Changes in Aerobic Capacity measure: Changes in Physical Strength measure: Motivation to Change measure: Utilization of Healthcare Resources measure: Fall History measure: Chronic Conditions measure: Changes in Overall Wellbeing measure: Changes in Depression measure: Changes in Anxiety measure: Changes in Physical Functioning measure: Changes in Social Isolation measure: Changes in Confidence in Exercises measure: Satisfaction with program measure: Satisfaction with program measure: Use of online program measure: Use of online program sex: ALL minimumAge: 60 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Roslindale Baptist Church status: RECRUITING city: Boston state: Massachusetts zip: 02131 country: United States name: Lydia Townsend role: CONTACT lat: 42.35843 lon: -71.05977 hasResults: False
<|newrecord|> nctId: NCT06267534 id: YCH briefTitle: Mindfulness-based Mobile Applications Program overallStatus: COMPLETED date: 2022-09-09 date: 2022-09-22 date: 2022-09-22 date: 2024-02-20 date: 2024-02-20 name: Yu-Chien Huang class: OTHER briefSummary: The goal of this type of study: quasi-experimental clinical trial . The purpose of this study is to explore the effects of applying mindfulness-based mobile applications program to maintaining mental health of emergency nurses during providing care to COVID-19 patients. The main question\[s\] it aims to answer are:
1. To explore the effect of mindfulness-based mobile device-assisted program on care stress of emergency nurses caring for COVID-19 patients.
2. To explore the impact of mindfulness-based mobile device-assisted programs on the psychological distress of emergency nurses caring for COVID-19 patients.
3. To explore the impact of a mindfulness-based mobile device-assisted program on compassion fatigue in emergency nurses caring for COVID-19 patients.
Participants will Mindfulness-based mobile device is provided to experimental group as assistance for 2 weeks. In the contrary, no intervention measure was assigned in the control group. Scale exam was performed before and after the program in both groups at the same time. conditions: COVID-19 conditions: Cell Phone Use conditions: Nurse conditions: Mental Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 102 type: ACTUAL name: mindfulness-based mobile applications program measure: The impact of mindfulness-based mobile device assistance program on the care stress of emergency nursing staff caring for COVID-19 patients measure: Effects of mindfulness-based mobile device assistance program on psychological distress among emergency nursing staff caring for COVID-19 patients measure: Effects of a mindfulness-based mobile device-assisted program on compassion fatigue among emergency nursing staff caring for COVID-19 patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yu-Chien Huang city: Taipei state: Zhongzheng District zip: 100 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False
<|newrecord|> nctId: NCT06267521 id: 2023-1473 id: Protocol Version 2/8/2024 type: OTHER domain: UW Madison id: L&S/PSYCHOLOGY/PSYCHOLOGY type: OTHER domain: UW Madison id: A487400 type: OTHER domain: UW Madison id: AWD00000302 type: OTHER_GRANT domain: US Department of Defense DARPA briefTitle: The STRENGTHEN Study overallStatus: RECRUITING date: 2024-03-06 date: 2025-02 date: 2025-02 date: 2024-02-20 date: 2024-03-27 name: University of Wisconsin, Madison class: OTHER name: United States Department of Defense briefSummary: This study uses two different types of interventions including electrical brain stimulation delivered during sleep, and brief, daily meditation training. The investigators are trying to figure out whether these techniques, either alone or in combination with each other, can positively impact the brain networks that support our ability to think flexibly and to regulate our emotions. 48 participants will be enrolled and can expect to be on study for up to 9 months. conditions: Cognitive Flexibility conditions: Emotional Regulation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Participants will not know whether they are in a group receiving active stimulation (groups 2, 3, and 4) or sham stimulation (group 1). However, participants will know whether they are performing meditation (groups 1, 3, and 4) or listening to only the didactic meditation material (group 2), and participants will be aware of how many nights they are undergoing stimulation (1 night per week for group 3, 2 nights per week for groups 1, 2, and 4). Thus, participants will be only partially blind to condition. Investigators will not be blind to condition. whoMasked: PARTICIPANT count: 48 type: ESTIMATED name: Healthy Minds Program name: Sham Meditation Didactic Material name: Sham Stimulation in Lab name: Stimulation in Lab name: MRI Scanner measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score measure: Change in General Anxiety Disorder (GAD-7) Score measure: Change in Single-item Suicide Question measure: Change in Healthy Minds Index (HM Index) measure: Change in the Perceived Stress Scale (PSS) Score measure: Change in Emotional Styles Questionnaire (ESQ) Score measure: Change in Cognitive Flexibility Inventory (CFI) Score: Alternatives Subscale measure: Change in Cognitive Flexibility Inventory (CFI) Score: Control Subscale measure: Change in Difficulties in Emotion Regulation Scale-18 (DERS-18) Score measure: Change in PROMIS Sleep Disturbance Score measure: Change in PTSD Checklist for DSM-5 (PCL-5) measure: Change in World Health Organization-5 (WHO-5) measure: Change in Restorative Sleep Questionnaire (RSQ) Score measure: Change in Sleep Depth Question (SDQ) Score measure: Change in Pittsburgh Sleep Quality Index (PSQI) Score measure: Change in Suicide Risk Survey measure: Change in Brief Suicide Cognitions Scale (B-SCS) Score measure: Change in Passive and Active Suicidal Ideation Scale (PASIS) Score measure: Change in NIH Toolbox Loneliness Score measure: Change in Five Facet Mindfulness Questionnaire (FFMQ) Score measure: Change in Drexel Defusion Scale (DDS) Score measure: Change in PROMIS Meaning and Purpose Score measure: Change in Digital Working Alliance Inventory (D-WAI) Score measure: Change in Perseverative Thinking Questionnaire (PTQ) Score measure: Change in Experiences Questionnaire's Decentering subscale (EQ-D) Score measure: Change in Experience Sampling / Ecological Momentary Assessment measure: Change in Death Implicit Association Test Score measure: Change in Reversal Learning Task Score measure: Change in Multi-Source Interference Task Score measure: Change in Emotional Stroop Score: Reaction Time measure: Change in Emotional Stroop Score: Percent Correct measure: Change in Meteor Mission Score: Mean Reaction Time measure: Change in Meteor Mission Score: Coefficient of Variation measure: Change in Meteor Mission Score: Percent Correct measure: Change in Emotional Persistence Task Score measure: Change in Change Your Mind Task Score: Mean Change measure: Change in Change Your Mind Task Score: Accuracy measure: Change in Change Your Mind Task Score: Response Time measure: Change in Spectral Power Density During Stimulation-Free Sleep measure: Resting-state fMRI Connectivity Z-Scores sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Center for Healthy Minds status: RECRUITING city: Madison state: Wisconsin zip: 53703 country: United States lat: 43.07305 lon: -89.40123 hasResults: False
<|newrecord|> nctId: NCT06267508 id: LMU-IMPH-LIFE2Scale briefTitle: Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment acronym: LIFE2Scale overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2025-12 date: 2024-02-20 date: 2024-02-20 name: Michael Hoelscher class: OTHER name: National Institute for Medical Research (NIMR) - Mbeya Medical Research Centre (MMRC) name: Instituto Nacional de Saúde (INS), Ministério da Saúde name: University of Liverpool briefSummary: This study aims to improve HIV healthcare services for mothers living with HIV and their newborns in Tanzania and Mozambique. The main questions it aims to answer are: 1) does enhancing screening with maternal HIV viral load monitoring at delivery identify more mother-child pairs at high-risk for HIV vertical transmission? and 2) are high-risk infants linked to appropriate prevention and care? The study will expand access to HIV testing services to more rural settings using a hub-and-spoke referral system. conditions: Vertical Human Immunodeficiency Virus Transmission conditions: HIV Infection Pediatric conditions: Infant Death conditions: Infant Morbidity conditions: Infant, Newborn, Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 6000 type: ESTIMATED name: Maternal HIV viral load testing at delivery for VHT risk assessment measure: Proportion of HIV-exposed infants correctly identified as low- or high-risk and receiving birth EID testing and ePNP or ART as appropriate within 7 days of life measure: Turnaround times for EID testing at birth, 4-6 weeks, and 14 weeks (time from sample collection to receipt of results by the health facility and communication of results to the mother/caregiver) and maternal PoC VL testing at delivery and 14 weeks measure: Proportion and rate of VHT at birth, week 4-8, and week 14 measure: Risk-factors associated with VHT measure: Adherence to PNP and ePNP measure: Proportion and rate of clinical endpoints (mortality, morbidity) among HIV-positive infants at week 14, month 6, and month 12 measure: Age at ART initiation among HIV-positive infants measure: Risk factors for poor ART adherence among high-risk mothers and infants measure: Proportion of HIV-positive infants virally suppressed at week 14, month 6, and month 12 measure: Risk factors for poor viral suppression among HIV-positive infants measure: Proportion of HIV-positive infants on ART that experience grade III or greater laboratory ART toxicity measure: Retention to HIV EID and infant health care services measure: Proportion of pregnant women presenting with criteria considered high-risk for VHT at delivery measure: Proportion of mothers virally suppressed at week 14 post-partum measure: Proportion and rate of post-partum mothers newly fulfilling high-risk criteria based on socio-behavioural criteria (i.e., adherence issues) measure: Characteristics of transmitted viral strains (lineages, subtypes, resistance mutations) among HIV-positive infants and in comparison to their mothers viral sequences measure: Proportion of HIV-positive infants who develop acquired drug resistance mutations during the study measure: Characteristics of infant and maternal HIV strains to be neutralized against a panel of known broadly neutralizing antibody candidates (e.g., VRC07, 10-1074) and maternal autologous antibodies at time of transmission measure: Average public healthcare and healthcare-related expenditures measure: Average health worker time needed to care for mothers and infants per clinic visit, including for enhanced counselling sessions measure: Cost per HIV-exposed infant fulfilling the primary outcome measure: Empirical cost-effectiveness (incremental cost-effectiveness ratio) relating intervention costs to life-years saved among HIV-positive infants measure: Average global and dimensional patient satisfaction measure: Hub-and-spoke model and provider satisfaction (health care personnel, focal point persons, counsellor) measure: Socio-behavioural and personal aspects related to high-risk criteria for mother-child pairs (adherence, retention, disclosure, emotional well-being and health care satisfaction) measure: Descriptions of tasks, functions, acceptability, challenge and workloads related to PVHT and neonatal HIV focal persons measure: Descriptions of tasks, functions, acceptability, challenge and workloads related to counsellors (enhanced high-risk counselling) measure: Description on eHealth functionality, satisfaction, acceptance of linkage procedures sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro de Investigacao Operacional de Beira (CIOB), Instituto Nacional de Saúde (INS), Ministério da Saúde, city: Beira country: Mozambique name: Joaquim Lequechane role: CONTACT name: Ilesh Jani, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: -19.84361 lon: 34.83889 facility: National Institute for Medical Research (NIMR) city: Mbeya country: Tanzania name: Issa Sabi, MD, PhD role: CONTACT name: Issa Sabi, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: -8.9 lon: 33.45 hasResults: False
<|newrecord|> nctId: NCT06267495 id: EOCXLFE briefTitle: Epithelium-on Cross-linking Versus Observation of Fellow Eyes of Patients With Unilateral Clinically Evident Keratoconus overallStatus: COMPLETED date: 2017-01-01 date: 2024-01-31 date: 2024-01-31 date: 2024-02-20 date: 2024-02-20 name: Assiut University class: OTHER briefSummary: Keratoconus (KC) is a bilateral asymmetric progressive corneal degenerative disease. The management of young patients, diagnosed with clinically evident KC in one eye and with no clinical signs of KC in the other eye, represents a real challenge for many ophthalmologists.
The aim of the current study is to investigate the effectiveness and safety of epithelium-on accelerated CXL to stabilize the eye with no clinical signs of KC, in young patients with unilateral clinically evident KC, compared with standard care and follow-up only. conditions: Keratoconus studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 40 type: ACTUAL name: Epithelium-on corneal cross-linking (epi-on CXL) measure: Steep keratometry value measure: Maximum keratometry value measure: Corrected distance visual acuity sex: ALL minimumAge: 12 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT facility: Tiba Eye Center city: Assiut zip: 71516 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False
<|newrecord|> nctId: NCT06267482 id: 122311 briefTitle: Using ROSA for Challenging The TKA Standard of Care overallStatus: RECRUITING date: 2024-04-16 date: 2025-04 date: 2025-06 date: 2024-02-20 date: 2024-04-18 name: Lawson Health Research Institute class: OTHER name: Zimmer Biomet briefSummary: This is a prospective, randomized controlled trial using the cruciate retaining, MC Persona to comparing the conventional TKA to ROSA assisted TKA. Patients will be randomized to one of three study trial arms.
1. Standard of care medial parapetallar approach (Control)
2. ROSA PSA medial parapetallar approach
3. ROSA PSA medial subvastus approach Participants will be followed for 1 year post surgery with a combination of perioperative parameters, imaging, patient reported outcomes, functional outcomes, blood and tissue sampling for inflammatory information and activity levels. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 90 type: ESTIMATED name: ROSA PSA Parapatellar Approach name: ROSA PSA Subvastus Approach measure: Functional Outcome - Weight-bearing CT scan measure: Functional Outcome - 3D Ultrasound measure: Functional Outcome - Timed Up and Go test measure: Patient health status - Knee Society Score measure: Patient health status - EuroQuol Survey measure: Patient health status - Knee Injury and Osteoarthritis Outcome Score measure: Patient health status - Western Ontario and McMaster Universities Arthritis Index measure: Patient health status - Global Assessment measure: Health Ecominics sex: ALL minimumAge: 21 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital status: RECRUITING city: London state: Ontario country: Canada lat: 42.98339 lon: -81.23304 hasResults: False
<|newrecord|> nctId: NCT06267469 id: Boutonniere deformity briefTitle: Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2024-09-30 date: 2024-09-30 date: 2024-02-20 date: 2024-02-20 name: Magdalena Kolasińska class: OTHER name: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland briefSummary: The goal of this study is to present the author's thumb orthosis with a butonier deformity and its effect on hand function, strength, dexterity and pain levels in relation to patients wearing factory-made orthopedic supplies. It is planned to include about 60 people in the study (30 people each in the group with thermoplastic orthoses and 30 participants with factory-made orthoses)
The main questions it aims to answer are:
1. How much improvement in dexterity will the patient wearing the orthosis get? 2. By how much will the grip strength of the whole hand and pincer grip strength improve with the orthosis? 3. How will wearing the orthosis affect the pain associated with the disease? Participants will
1. measurement of grip strength of the right and left hands with a dynamometer in an orthosis and without an orthosis, at the time of the test conducted and at the appointed times.
2. measurement of pincer grip strength with a dynamometer in an orthosis and without an orthosis, at the time of the test conducted and at the designated times.
4. completion of the DASH questionnaire 6. assessment of the NRS pain scale in relation to the period of 6 months before the start of the study 7. Likert scale - evaluation of satisfaction with the use of the orthosis 8. the Kapandji scale Researchers will compare patients with thermoplastic orthosis and patients with fabric orthosis to see which is more functional. conditions: Orthotic Devices studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: Thermoplastic orthosis measure: Grip strength measure: DASH -Disabilities of the Arm, Shoulder and Hand measure: Likert scale measure: Kapandji score measure: NRS - Numerical Rating Scale measure: pinch strength sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher city: Warsaw state: Mazowieckie zip: 02-637 country: Poland name: Magdalena Kolasińska, Msc role: CONTACT phone: +48609219822 email: magdalena.kolasinska@awf.edu.pl name: Teresa Sadura-Sieklucka, Phd role: CONTACT email: teresa.sadura@awf.edu.pl lat: 52.22977 lon: 21.01178 facility: Terapia Ręki Magda Kolasińska city: Warszawa state: Mazowieckie zip: 01-494 country: Poland name: Magdalena Kolasińska, Msc role: CONTACT phone: +48609219822 email: magdalena.kolasinska@awf.edu.pl lat: 52.22977 lon: 21.01178 hasResults: False
<|newrecord|> nctId: NCT06267456 id: HÜ- FTR- BD- 01 briefTitle: The Reliability of ULRT in Overhead Athletes and Its Relationship With Selected UEPT overallStatus: COMPLETED date: 2022-01-01 date: 2023-01-01 date: 2023-01-10 date: 2024-02-20 date: 2024-02-28 name: Hacettepe University class: OTHER briefSummary: Upper Extremity Rotation Test is a new test the evaluates 90-90 position, which is one of the requirements for overhead throwing. The aim of the study was to evaluate the reliability of the Upper Extremity Rotation Test in overhead athletes and the relationship between the Closed Chain Upper Extremity Stability Test and the Upper Quarter Y Balance Test. conditions: Upper Limb Asymmetry studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: handball, volleyball and basketball players 18-30 years Someone who has been participating in sports for at least three years and trains at least three times a week primaryPurpose: DIAGNOSTIC masking: NONE count: 48 type: ACTUAL name: Upper Limb Rotation Test name: Closed Kinetic Chain Upper Extremity Stability Test name: Upper Quarter Y Balance Test measure: The reliability of Upper Extremity Rotation Test measure: The Relationship Assessment of the Upper Extremity Rotation Test sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Birgül Dıngırdan city: Kocaeli state: İzmit country: Turkey lat: 39.62497 lon: 27.51145 facility: Hacettepe University city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<|newrecord|> nctId: NCT06267443 id: 2023/337 briefTitle: Erector Spina Block or Parasternal Block Plus Chest Tube Wound Infiltration for Cardiac Surgeries overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-07-01 date: 2024-08-01 date: 2024-02-20 date: 2024-02-20 name: TC Erciyes University class: OTHER briefSummary: Pain management is important after coronary artery bypass graft (CABG) surgery. Intravenous morphine is the gold standard for pain relief, but its sedation, cough suppression and decreased bowel movements limit its use. Analgesia with regional methods after surgery provides effective analgesia by reducing morphine consumption. In this study we have planned to compare the erector spina plane block with parasternal block +local infiltration to chest tube areas. conditions: Postoperative Pain conditions: Postoperative Atelectasis conditions: Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Comparison of erector spina plane block, parasternal block plus local infiltration to the tube sides for postoperative analgesia measure: postoperative analgesia measure: postoperative atelectasia measure: postoperative mechanical ventilation duration sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06267430 id: NL85141.078.23 briefTitle: Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With a Severe CHD acronym: LbH overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2027-04-30 date: 2024-02-20 date: 2024-02-20 name: Erasmus Medical Center class: OTHER briefSummary: Advances in prenatal and neonatal care have improved outcomes in children with severe congenital heart disease (CHD). With the increase in survival, neurocognitive problems such as executive functioning (EF) impairments have become more apparent in these children. EF problems have cascading negative effects on a child's development. New insights in EF development suggest that in otherwise physically healthy young children, EF can be improved by training. In a pilot study funded by Stichting Hartekind, the investigators studied the feasibility of a personalized EF training program called 'Kleuter Extra' and the results were promising. Therefore, the current study will investigate the effectiveness of this program in 4-6-year-old children with severe CHD. The researchers will also explore interactions between the parent-child relationship and EF development of the child as psychosocial difficulties in these children and their parent(s) and/or caretaker(s) may impact EF-development. If found effective, EF training for children with severe CHD will improve their developmental outcome. conditions: Congenital Heart Disease conditions: Executive Dysfunction conditions: Attention Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The psychologist testing all participants, will be blinded for the allocation of the participants. whoMasked: INVESTIGATOR count: 141 type: ESTIMATED name: Kleuter Extra training program measure: Kleuter Extra test battery measure: EF functioning measure: Information processing measure: Executive functioning in daily life - completed by the parent(s) measure: Behavioral and emotional difficulties of the child - completed by the parent(s) measure: Quality of the child's life - completed by the parent(s) measure: Emotional distress parent - completed by the parent(s) measure: Parental trauma measure: Parenting behavior and quality parent-child relationship - completed by the parent(s) measure: Child demographics teacher's perspective measure: Behavioral and emotional difficulties teacher's perspective measure: Executive functioning child in daily life teacher's perspective sex: ALL minimumAge: 4 Years maximumAge: 6 Years stdAges: CHILD facility: University Medical Center - Beatrix children's hospital Groningen city: Groningen zip: 9713GZ country: Netherlands name: Hessel Nijenhuis role: CONTACT email: h.p.nijenhuis@umcg.nl lat: 53.21917 lon: 6.56667 facility: Erasmus Medical Center Sophia Children's Hospital city: Rotterdam zip: 3015CN country: Netherlands name: André Rietman role: CONTACT email: a.rietman@erasmusmc.nl lat: 51.9225 lon: 4.47917 facility: University Medical Center - Wilhelmina children's hospital Utrecht city: Utrecht zip: 3584EA country: Netherlands name: Hans Breur role: CONTACT phone: +31 88 75 754 59 email: h.breur@umcutrecht.nl lat: 52.09083 lon: 5.12222 hasResults: False
<|newrecord|> nctId: NCT06267417 id: CCHE-AML-4/2023 briefTitle: Laser Therapy Effect as Preventive Measure for Oral Mucositis in Children With Hematological Malignancies overallStatus: RECRUITING date: 2023-04-10 date: 2024-04-01 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: Children's Cancer Hospital Egypt 57357 class: OTHER briefSummary: Introduction:
Among the most drastic complications of chemotherapy is oral mucositis(OM). It is a painful inflammatory, often ulcerative condition and may increase risk for systemic infections leading to prolonged hospital stays and interruptions of treatment protocol. Many treatment modalities have been introduced for the prevention and treatment of oral mucositis , of which low level laser therapy(LLLT) is gaining popularity. The use of LLLT as a prophylactic treatment for chemotherapy induced oral mucositis in pediatric cancer patients is still lacking robust evidence. Also, the parameters used have not been optimized and no standard method has yet been established. Based on this point, this study will compare photobiomodulation to the conventional preventive program of oral mucositis applied in 57357 children's cancer hospital foundation to determine which will be optimal for the prophylaxis of chemotherapy-induced OM.
Aim:
To assess the effectiveness of low level laser therapy in the prophylaxis of oral mucositis in pediatric patients diagnosed with Hematological cancers.
Methods:
This study is a randomized, prospective, double-blinded trial that will include acute Myeloid leukemia patients admitted to receive chemotherapy cycle between the age of 3 and 18years. These patients will be randomized into two groups: group 1 will receive low level laser therapy and group 2 will receive mock treatment. Patient will be followed to asses the development of oral mucositis on prespecified time points. conditions: Oral Mucositis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: The outcome evaluator will be a single personnel from the oncology team following up with the case whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: Laser therapy name: Mock treatment measure: To measure incidence of oral mucositis in Laser arm versus Placebo arm. measure: To measure grade of oral mucositis in patients receiving laser arm placebo arm. sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Children Cancer Hospital 57357 status: RECRUITING city: Cairo zip: 11617 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<|newrecord|> nctId: NCT06267404 id: IShamsi briefTitle: Effectiveness of Iliopsoas Positional Release Versus Conventional Exercises in the Management of Sub-acute Back Pain. overallStatus: RECRUITING date: 2024-02-21 date: 2025-02-15 date: 2025-02-25 date: 2024-02-20 date: 2024-02-22 name: University of Karachi class: OTHER name: Sindh Institute of Physical Medicine and Rehabilitation briefSummary: Recommended treatment for chronic non-specific LBP is exercise therapy, behavioral therapy including pain management, or a combination of these; There is not enough evidence to establish recommendations for which one is the most appropriate.
The primary objective of this study is to explore the effects of Ilio-psoas Release on Sub-acute back pain, ROM \& functional disability conditions: Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Iliopsoas Positional release therapy name: Conventional exercises measure: VAS Visual Analogue Scale VAS Visual Analogue Scale measure: Modified Schober's test measure: Roland-Morris Disability Questionnaire sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Sindh Institute of Physical Medicine and Rehabilitation status: RECRUITING city: Karachi state: Sindh country: Pakistan name: Iram I Shamsi, MPhil role: CONTACT name: Iram I Shamsi, MPhil role: PRINCIPAL_INVESTIGATOR lat: 24.8608 lon: 67.0104 hasResults: False
<|newrecord|> nctId: NCT06267391 id: 898 briefTitle: Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes acronym: ReCET overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-01 date: 2026-10-01 date: 2024-02-20 date: 2024-02-20 name: Endogenex, Inc. class: INDUSTRY briefSummary: This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications. conditions: Type 2 Diabetes Mellitus conditions: Type2diabetes conditions: Diabetes Mellitus, Type 2 conditions: Diabetes conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The participants randomized in a 2:1 ratio to the ReCET treatment arm or the sham control arm. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 264 type: ESTIMATED name: ReCET Treatment name: Sham Procedure measure: HbA1c measure: HbA1c measure: HbA1c ≤7.0% without requiring rescue medication measure: Time-in Range (TIR) measure: Total body weight loss (%TBWL) measure: Incidence of adverse events sex: ALL minimumAge: 22 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06267378 id: 1174/2022/NCTS briefTitle: Assessing Frailty and Its Impacts on Patients Facing Major GI Surgery overallStatus: RECRUITING date: 2023-08-30 date: 2024-12-01 date: 2029-12-01 date: 2024-02-20 date: 2024-02-20 name: Doncaster And Bassetlaw Hospitals NHS Foundation Trust class: OTHER briefSummary: The study team will look at 3 new tests that will make it easier to measure frailty in patients awaiting surgery for cancer and compare them against standard clinical measures of frailty in a pilot study. The expected outcome is that evidence will be collated in order to apply for a major grant to look at improving the care of frail patients with cancer in the future. conditions: Bowel Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Frailty measure measure: The sensitivity & specificity of digital motion data for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events measure: The sensitivity & specificity of tissue senescence for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events measure: The sensitivity & specificity of blood based biomarkers for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events measure: Blood biomarker correlation (baseline and post operative) with baseline frailty and poor outcomes (including length of stay and adverse events) measure: Adverse events related to surgery assessed CTCAE classifications measure: Tissue senescence correlation between baseline frailty and poor outcomes (including length of stay and adverse events) measure: Digital mobility outcomes correlation with baseline frailty and poor outcomes (including length of stay and adverse events) measure: Physical function assessment after surgery at 6 weeks, 3 months using the WHO DAS 2.0. measure: Quality of life at 6 weeks, 3 months after surgery using the EQ-5D-5L measure: Overall survival at 3 months and 5 years (the latter via cancer registry returns) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust status: RECRUITING city: Doncaster state: South Yorkshire zip: DN2 5LT country: United Kingdom name: Doncaster Royal Infirmary role: CONTACT email: dbth.clinicalresearch@nhs.net lat: 53.52285 lon: -1.13116 hasResults: False
<|newrecord|> nctId: NCT06267365 id: 23-00766 briefTitle: Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis overallStatus: RECRUITING date: 2023-11-27 date: 2025-06-01 date: 2025-09-01 date: 2024-02-20 date: 2024-02-20 name: NYU Langone Health class: OTHER name: National Institute of Neurological Disorders and Stroke (NINDS) briefSummary: This is an observational prospective study to develop predictive biomarkers for pain response in participants with chronic pancreatitis scheduled for endoscopic therapy. Participants will undergo baseline assessments including electroencephalography (EEG), quantitative sensory testing (QST), and psychosocial questionnaires. Response to endoscopic therapy will be assessed at approximately 3, 6, 12 and 18 months post-procedure using questionnaires. conditions: Chronic Pancreatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Change from Baseline in Brief Pain Inventory (BPI) Score at Month 3 Post-Operation measure: Change from Baseline in BPI Score at Month 6 Post-Operation measure: Change from Baseline in BPI Score at Month 12 Post-Operation measure: Change from Baseline in BPI Score at Month 18 Post-Operation measure: Change from Baseline in Patient Reported Outcome System (PROMIS) - Physical Function - Short Form 6b Score at Month 3 Post-Operation measure: Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 6 Post-Operation measure: Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 12 Post-Operation measure: Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 18 Post-Operation measure: Number of Participants who use Opioids at Baseline measure: Number of Participants who use Opioids at Month 3 measure: Number of Participants who use Opioids at Month 6 measure: Number of Participants who use Opioids at Month 12 measure: Number of Participants who use Opioids at Month 18 measure: Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 3 Post-Procedure measure: Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 6 Post-Procedure measure: Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 12 Post-Procedure measure: Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 18 Post-Procedure measure: Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 3 Post-Procedure measure: Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 6 Post-Procedure measure: Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 12 Post-Procedure measure: Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 18 Post-Procedure measure: Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 3 Post-Procedure measure: Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 6 Post-Procedure measure: Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 12 Post-Procedure measure: Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 18 Post-Procedure measure: Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 3 Post-Procedure measure: Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 6 Post-Procedure measure: Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 12 Post-Procedure measure: Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 18 Post-Procedure measure: Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 3 Post-Procedure measure: Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 6 Post-Procedure measure: Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 12 Post-Procedure measure: Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 18 Post-Procedure measure: Change from Baseline in Pain Catastrophizing Scale (PCS) Score at Month 3 Post-Procedure measure: Change from Baseline in PCS Score at Month 6 Post-Procedure measure: Change from Baseline in PCS Score at Month 12 Post-Procedure measure: Change from Baseline in PCS Score at Month 18 Post-Procedure measure: Change from Baseline in Sleep Duration at Month 3 Post-Procedure measure: Change from Baseline in Sleep Duration at Month 6 Post-Procedure measure: Change from Baseline in Sleep Duration at Month 12 Post-Procedure measure: Change from Baseline in Sleep Duration at Month 18 Post-Procedure measure: Change from Baseline in Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Score at Month 3 Post-Procedure measure: Change from Baseline in TAPS Score at Month 6 Post-Procedure measure: Change from Baseline in TAPS Score at Month 12 Post-Procedure measure: Change from Baseline in TAPS Score at Month 18 Post-Procedure measure: Change from Baseline in Patient Global Impression of Change (PGIC) Score at Month 3 Post-Procedure measure: Change from Baseline in PGIC Score at Month 6 Post-Procedure measure: Change from Baseline in PGIC Score at Month 12 Post-Procedure measure: Change from Baseline in PGIC Score at Month 18 Post-Procedure measure: Change from Baseline in Patient Health Questionnaire-2 (PHQ-2) Score at Month 3 Post-Procedure measure: Change from Baseline in PHQ-2 Score at Month 6 Post-Procedure measure: Change from Baseline in PHQ-2 Score at Month 12 Post-Procedure measure: Change from Baseline in PHQ-2 Score at Month 18 Post-Procedure measure: Change from Baseline in Generalized Anxiety Disorder 2 (GAD-2) Score at Month 3 Post-Procedure measure: Change from Baseline in GAD-2 Score at Month 6 Post-Procedure measure: Change from Baseline in GAD-2 Score at Month 12 Post-Procedure measure: Change from Baseline in GAD-2 Score at Month 18 Post-Procedure measure: Change from Baseline in Pain, Enjoyment of Life and General Activity (PEG) Scale at Month 3 Post-Procedure measure: Change from Baseline in PEG Scale at Month 6 Post-Procedure measure: Change from Baseline in PEG Scale at Month 12 Post-Procedure measure: Change from Baseline in PEG Scale at Month 18 Post-Procedure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health status: RECRUITING city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 hasResults: False
<|newrecord|> nctId: NCT06267352 id: 230097 briefTitle: Epidemiology and Genomic Surveillance of Staphylococcus Aureus in ICU Neonatology acronym: NEOSAUR overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-06 date: 2024-02-20 date: 2024-02-20 name: University Hospital, Caen class: OTHER briefSummary: Newborns hospitalized in Neonatology are particularly vulnerable to infections, in particular healthcare associated infection (HAI). Staphylococcus aureus represents the 2nd microorganism responsible for sepsis, this infection is particularly serious and like any HAI, it increases the length of hospitalization of newborns and neonatal morbidity.
In September 2020, the CDC published recommendations for the prevention and control of Staphylococcus aureus infections in neonatal intensive care unit/ICU. They specify the indications for implementing a MSSA surveillance strategy as well as the screening and management methods.
Despite the absence of a defined strategy at the national level, our establishment chose to initiate management measures several years ago following serious infections and MSSA epidemics in neonatal intensive care unit/ICU.
With the aim of improving the efficiency of care and evaluating the strategy chosen at the establishment, it is necessary to describing