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Double-Bundle ACL + ALL Reconstruction Group:
* Patients in this group will undergo anatomic double-bundle ACL reconstruction using two graft bundles to more anatomically replicate the native ACL's anteromedial and posterolateral bundles.
* Like the single-bundle group, they will also have supplemental ALL reconstruction performed using a portion of the graft material.
* The double-bundle ACL reconstruction aims to better restore the ACL's complex anatomic footprint and bundles' tension patterns. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Single-bundle ACL combined anterolateral ligament reconstruction name: Double-bundle ACL combined anterolateral ligament reconstruction measure: Patient-reported outcome measures (PROMs) measure: Patient-reported outcome measures (PROMs) measure: Patient-reported outcome measures (PROMs) measure: Knee ligament stability: measure: Knee ligament stability clinical evaluation measure: Knee ligament stability clinical evaluation measure: Knee ligament stability clinical evaluation measure: Functional performance and return to sport measure: Functional performance and return to sport measure: Imaging measure: Imaging sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chang Gung memorial hospital city: Taoyuan zip: 333 country: Taiwan name: Cheng-Pang Yang, Dr role: CONTACT email: [email protected] lat: 24.95233 lon: 121.20193 hasResults: False
<|newrecord|> nctId: NCT06341179 id: M2S id: H-23063352 type: OTHER domain: Vek.dk briefTitle: Effect of Sleep Extension on Overweight and Learning in Children acronym: More2Sleep overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2027-12-31 date: 2024-04-02 date: 2024-04-02 name: University of Copenhagen class: OTHER name: Novo Nordisk A/S name: Faculty of Health, Medicine and Life Sciences, Maastricht University name: Center for Obesity Research & Education, Temple University name: Danish Research Centre for Magnetic Resonance name: University of Southern Denmark briefSummary: More2Sleep is a randomized, controlled, parallel trial with two groups (sleep extension vs control) including 300 school-aged children (6-9 years) who are mildly overweight or obese and habitually sleep for ≤ 9 h/night. Data will be collected before and after a 3-month sleep extension intervention, and after a 6-month follow-up (at months 0, 3, and 9). The collection of data is mainly related to the main study. However, some optional examinations will be conducted on a first come, first serve basis, consisting of substudy-I (metabolic mechanisms, n=60) and substudy-II (learning mechanisms, n=150).
The primary objective is to assess the effects of sleep extension by \~45 min/night, achieved by going to bed 60-90 min earlier, on adiposity and learning ability in school-aged children who are overweight or obese, and sleep less than recommended for their age. conditions: Sleep Duration conditions: Child Obesity conditions: Child Development conditions: Child Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Sleep extension measure: BMI Z-score measure: Learning ability: skill learning measure: Learning ability: Explicit memory measure: Body fat percent measure: Total fat mass (FM) measure: Total lean mass (LM) measure: Bone mineral content (BMC) measure: Bone mineral density (BMD) measure: Dietary energy intake measure: Dietary protein, carbohydrate, fiber, and fat intakes measure: Subjective hunger measure: Physical activity (PA) time: total PA and MVPA measure: Resting metabolic rate (RMR) measure: Thermic effect of food (TEF) measure: Weight measure: Height measure: Total energy expenditure (TEE) measure: Fasting and postprandial glucose concentration measure: Fasting and postprandial insulin concentration measure: Fasting and postprandial total, HDL and LDL cholesterol concentrations measure: Fasting and postprandial triglyceride concentration measure: Fasting and postprandial C-reactive protein concentration measure: Fasting and postprandial tumor necrosis factor alpha concentration measure: Fasting and postprandial ghrelin concentration measure: Fasting and postprandial leptin concentration measure: Fasting and postprandial glucagon like peptide 1 concentration measure: Fasting and postprandial peptide YY concentration measure: Fasting and postprandial cholecystokinin concentration measure: Fasting and postprandial interleukin 6 concentration measure: Cognitive functions: processing speed measure: Cognitive functions: Sustained attention measure: Cognitive functions: Spatial working memory measure: Cognitive functions: Inhibitory control measure: Cognitive functions: Cognitive flexibility measure: School performance: mathematics performance measure: School performance: reading comprehension measure: Neurophysiological Measurement 1 - ERP Amplitude measure: Neurophysiological Measurement 2 - Cortical activity during skill learning measure: Neurophysiological Measurement 3 - Muscle activity during skill learning measure: Neurophysiological Measurement 4 - corticocortical functional connectivity measure: Neurophysiological Measurement 5 - corticomuscular connectivity measure: Health-related quality of life: child-reported measure: Health-related quality of life: parent-reported measure: Mental health: parent-reported measure: Parental Stress Scale: parent-reported measure: Perceived Stress Scale: child-reported measure: Demographics: income measure: Demographics: education measure: Wakefulness measure: Handedness measure: Fine Motor Control measure: Muscle strength measure: Brain myelination measure: Brain structural connectivity and microstructure measure: Brain functional connectivity measure: Vital signs: blood pressure measure: Vital signs: heart rate measure: Vital signs: temperature measure: Sleep quality: self-reported sleep duration measure: Sleep quality: self-reported latency measure: Sleep quality: self-reported awakenings measure: Sleep quality: self-reported tiredness/sleepiness measure: Sleep quality and architecture: Sleep stages measure: Sleep quality and architecture: sleep duration measure: Sleep quality and architecture: sleep latency measure: Sleep quality and architecture: awakenings measure: Sleep quality and architecture: arousals measure: Sleep: duration measure: Sleep: movements measure: Sleep: awakenings measure: Brain structure: cortical thickness measure: Brain structure: volume measure: Brain structure: Surface measure: Brain structure: volumes of subcortical grey matter structures sex: ALL minimumAge: 6 Years maximumAge: 9 Years stdAges: CHILD facility: University of Copenhagen city: Copenhagen zip: 1958 country: Denmark name: Faidon Magkos, PhD role: CONTACT phone: +45 35 33 36 71 email: [email protected] name: Cecilie Rasmussen, MSc role: CONTACT phone: +45 35 33 58 27 email: [email protected] name: Faidon Magkos, PhD role: PRINCIPAL_INVESTIGATOR name: Jesper Lundbye-Jensen, PhD role: SUB_INVESTIGATOR name: Poul Jennum, MD role: SUB_INVESTIGATOR lat: 55.67594 lon: 12.56553 facility: University of Copenhagen city: Copenhagen zip: 2200 country: Denmark name: Faidon Magkos, PhD role: CONTACT phone: +45 35 33 36 71 email: [email protected] name: Jesper Lundbye-Jensen, PhD role: CONTACT phone: +45 35 32 73 30 email: [email protected] name: Faidon Magkos, PhD role: PRINCIPAL_INVESTIGATOR name: Jesper Lundbye-Jensen, PhD role: SUB_INVESTIGATOR name: Poul Jennum, MD role: SUB_INVESTIGATOR lat: 55.67594 lon: 12.56553 facility: Faidon Magkos city: Hvidovre zip: 2650 country: Denmark name: Faidon Magkos, PhD role: CONTACT phone: +45 35 33 36 71 email: [email protected] name: Faidon Magkos, PhD role: PRINCIPAL_INVESTIGATOR name: Jesper Lundbye-Jensen, PhD role: SUB_INVESTIGATOR name: Kathrine Madsen, PhD role: SUB_INVESTIGATOR name: Hartwig Siebner, MD role: SUB_INVESTIGATOR name: Poul Jennum, MD role: SUB_INVESTIGATOR lat: 55.65719 lon: 12.47364 hasResults: False
<|newrecord|> nctId: NCT06341166 id: CCM1959 briefTitle: Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse acronym: SCIMITAR overallStatus: RECRUITING date: 2023-06-19 date: 2025-06-19 date: 2025-06-19 date: 2024-04-02 date: 2024-04-02 name: Centro Cardiologico Monzino class: OTHER name: Treviso Regional Hospital name: Humanitas Hospital, Italy name: IRCCS Ospedale San Raffaele briefSummary: This is a multicenter, observational prospective and retrospective study which aims are: 1) to compute a scoring model potentially predictive for the diagnosis of fibrosis by CMR in patients with MVP; 2) to identify specific features that may predispose to ≥ mild VAs or SCD in patients with MVP. conditions: Mitral Valve Prolapse studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 300 type: ESTIMATED measure: Prediction of fibrosis by CMR measure: Prediction of ≥ mild Ventricular Arrhythmias and/or Sudden cardiac death in mitral valve sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro Cardiologico Monzino status: RECRUITING city: Milan zip: 20131 country: Italy name: Chiara Centenaro role: CONTACT phone: 0258002031 phoneExt: +39 email: [email protected] lat: 45.46427 lon: 9.18951 hasResults: False
<|newrecord|> nctId: NCT06341153 id: SelcukUni2542 briefTitle: The Effect Of Breast Milk Sniffing And Tasting On Early Feeding Tips overallStatus: COMPLETED date: 2022-07-15 date: 2022-09-15 date: 2023-11-15 date: 2024-04-02 date: 2024-04-02 name: Sibel Küçükoğlu class: OTHER name: Health Institutes of Turkey briefSummary: The study aimed to investigate the effects of breast milk sniffing and breast milk tasting and sniffing on sucking success and early feeding cues in term newborns who were started to breastfeed for the first time. conditions: Breastfeeding conditions: Odors, Body conditions: Newborn; Vitality studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The stratification and blocking method was used to assign the mothers who would participate in the study to the experimental and control groups, taking into account factors such as normal or cesarean delivery and breastfeeding experience. In order to ensure homogeneity in the groups, mothers were stratified as mode of delivery (Normal-Cesarean) and breastfeeding experience (Present-Non-existent). After the blocks were formed, the groups included in the study were randomly assigned to the strata with the letters A, B and C using the random numbers table obtained in the computer environment (www.random.org). Which letter would be in which group was determined by lot (A=Odor Stimulation, B=Odor+Taste Stimulation, C=Control Group). primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: According to the a priori power analysis with a pairwise hypothesis, effect size of 0.409, significance level of 0.05 and power of 0.80; it was determined that the inclusion of a total of 72 newborns (Odor Stimulation: 24, Odor+taste stimulation: 24, Control: 24) in the study would provide sufficient sample size.
Inclusion Criteria; For the mother;
* Having a term and healthy baby,
* No communication and language problems,
* No maternal illness preventing breastfeeding (active chemotherapy, HIV positive, neurological or psychological problems, etc.),
* Willingness to breastfeed, For the baby;
* Not having a disease condition that prevents breastfeeding (cleft palate, cleft lip, galactotemia, choanal atresia, etc.),
* Being at normal birth weight (2500gr-4000gr),
* Apgar score of 7 and above. whoMasked: INVESTIGATOR count: 72 type: ACTUAL name: Breast Milk Odor Stimulation name: Stimulation of Breast Milk Smell and Taste measure: Introductory Information Form measure: Early Feeding Tips Scale measure: Breastfeeding Identification and Assessment Scale (LATCH) measure: Early Feeding Tips Scale measure: Breastfeeding Identification and Assessment Scale (LATCH) measure: Early Feeding Tips Scale measure: Breastfeeding Identification and Assessment Scale (LATCH) sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Selcuk University city: Konya state: Selcuklu zip: 42100 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
<|newrecord|> nctId: NCT06341140 id: secil koken briefTitle: The Effect of Breastfeeding Support on Exclusive Breastfeeding, Occurrence of Breast Problems and Breastfeeding Self-Efficacy overallStatus: COMPLETED date: 2021-08-01 date: 2022-11-30 date: 2023-02-06 date: 2024-04-02 date: 2024-04-02 name: Celal Bayar University class: OTHER name: Manisa Celal Bayar University briefSummary: The aim of the study is to determine the effect of individual breastfeeding support on the lactation process. The research is a randomized controlled experimental study. The sample of the study consisted of pregnant women who applied to the Obstetrics Polyclinic of a university hospital (intervention=51, control=51). In the study, individual breastfeeding education was given to the intervention group during the antenatal period, and a training booklet was given to the control group. In the postpartum period, home visits and phone follow-ups were carried out for both groups between the fifth day and the sixth month. The effect of breastfeeding counseling on the lactation process; The duration of exclusive breastfeeding, breast problems and breastfeeding success was evaluated with. The data of the study were collected using the Pregnant, Postpartum-Newborn Information Form, Breastfeeding Questionnaire, Breast Problems Diagnosis Form, LATCH Breastfeeding Diagnostic Tool and Breastfeeding Self-Efficacy Scale. conditions: Breastfeeding conditions: Breastfeeding, Exclusive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 102 type: ACTUAL name: Breastfeeding support and Booklet containing information about breastfeeding name: Booklet containing information about breastfeeding measure: Situation of mothers feeding their babies exclusively with breast milk measure: Mothers experiencing breast problems measure: Determination of mothers' breastfeeding self-efficacy sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Manisa Celal Bayar University city: Manisa country: Turkey lat: 38.61202 lon: 27.42647 hasResults: False
<|newrecord|> nctId: NCT06341127 id: 2023-01 briefTitle: Fluoxetine in KCNC1-related Disorder overallStatus: ENROLLING_BY_INVITATION date: 2024-01-17 date: 2024-12-01 date: 2025-12-31 date: 2024-04-02 date: 2024-04-02 name: Holland Bloorview Kids Rehabilitation Hospital class: OTHER name: The Hospital for Sick Children briefSummary: This is a single patient study of oral powdered fluoxetine to target developmental outcomes in a child with KCNC1-related disorder. This trial will be conducted at Holland Bloorview Kids Rehabilitation Hospital over 32 to 42 weeks, using a quasi experimental ABA phase design (placebo-fluoxetine-placebo) with randomized and blinded active treatment start and stop moments. conditions: KCNC1 Related Disorder conditions: Genetic Disease conditions: Rare Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE maskingDescription: This quasi experimental design involves masking of transition moments, but the investigator and participant are aware of the order of cross-over. count: 1 type: ESTIMATED name: Fluoxetine measure: Motor development measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] measure: Adaptive skills measure: Cognitive skills measure: Family priority outcome targets measure: Clinical Global Impression- Improvement Scale (CGI-I) sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Holland Bloorview Kids Rehabilitation Hospital city: Toronto state: Ontario zip: M5G1R8 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False
<|newrecord|> nctId: NCT06341114 id: BAT-8008-1308-001-CR briefTitle: A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04-12 date: 2026-04-03 date: 2026-07-28 date: 2024-04-02 date: 2024-04-02 name: Bio-Thera Solutions class: INDUSTRY briefSummary: The study, led by Zhejiang Cancer Hospital and sponsored by Bio-Thera Solutions, Ltd., is an exploratory multicenter, open-label phase Ib-II clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of the combination of BAT8008 with BAT1308 in patients with advanced solid tumors.
This study aims to explore the safety, tolerability, and pharmacokinetic characteristics of BAT8008 combined with BAT1308 in patients with advanced solid tumors, determine the maximum tolerated dose (MTD), provide recommended doses and reasonable dosing regimens for subsequent clinical studies, and preliminarily evaluate the antitumor efficacy.
The study is divided into two stages. The first stage will use a "3+3" dose escalation design to explore the safety and tolerability of the investigational drugs. In the second stage, based on the preliminary safety and efficacy results from the first stage, appropriate doses and tumor types will be selected for expansion studies within the safety dose range to further investigate the safety and clinical efficacy of BAT8008+BAT1308 and provide evidence for subsequent clinical studies. conditions: Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: BAT8008 injection name: BAT1308 injection measure: Dose-limiting toxicity (DLT) measure: vital signs measure: Physical examination measure: Adverse events measure: Clinical laboratory tests measure: Clinical auxiliary tests measure: Objective response rate (ORR) measure: Duration of Response(DOR) measure: Disease Control Rate (DCR) measure: Progression Free Survival(PFS) measure: Overall Survival(OS) measure: Pharmacokinetic measure: Pharmacokinetic measure: Pharmacokinetic measure: Pharmacokinetic measure: Pharmacokinetic measure: Pharmacokinetic sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06341101 id: 2022-503135-33-00 id: 2022-503135-33-00 type: OTHER domain: EU trial number briefTitle: Timely Recovery After Subclinical Heart Failure acronym: TREASURE overallStatus: RECRUITING date: 2024-03-26 date: 2026-03-01 date: 2026-03-01 date: 2024-04-02 date: 2024-04-02 name: Academisch Ziekenhuis Maastricht class: OTHER name: ZonMw: The Netherlands Organisation for Health Research and Development briefSummary: The goal of this randomized controlled trial is to assess the effectiveness of ACE inhibitors versus standard care) in reversing asymptomatic heart failure (HF stage-B) and/or diastolic dysfunction during a two-year open-label treatment period for formerly preeclamptic women on:
1. Reversibility of structural and functional myocardial impairment in asymptomatic HF towards healthy values;
2. The progression from asymptomatic to symptomatic HF (symptoms scored based on the NYHA criteria);
3. Cardiovascular performance (volume- and pressure load), cardio metabolic risk factors (glucose metabolism, lipid status, kidney function) and quality of life (questionnaires);
4. Novel biomarkers and relevant microRNA's indicative for hypertrophy, fibrosis inflammation and ischemia.
Eligible subjects will be counselled and upon informed consent randomized for either medication group (n=65) or care as usual group (n=65). After a complete cardiovascular assessment, medication will be initiated open-labeled (Perindopril 2 mg or no medication). Thereafter, standard medical check-ups (blood pressure, ECG, kidney function, transthoracic cardiac ultrasound, endothelial function, quality of life questionnaires, medical history taking, blood and urine banking) will be performed every six months for two years.
Researchers will compare ACE inhibitor (Perindopril 2 mg) and care as usual (i.e. no medication) to investigate whether ACE inhibitor allows timely recovery after subclinical heart failure. conditions: Heart Failure conditions: Diastolic Dysfunction studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: Perindopril measure: No left Ventricular Hypertrophy measure: No concentric remodeling measure: No impaired systolic function measure: Normal diastolic function sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AZMaastricht status: RECRUITING city: Maastricht state: Limburg zip: 6202AZ country: Netherlands name: Marc Spaanderman, Prof role: CONTACT phone: +31(0)43-3874145 email: [email protected] lat: 50.84833 lon: 5.68889 hasResults: False
<|newrecord|> nctId: NCT06341088 id: B.30.2.ATA.0.01.00/132 briefTitle: Evaluation of Anatomical Results and Sexual Functions After Unilateral and Bilateral Laparoscopic Suture Sacro-hysteropexy Operations overallStatus: RECRUITING date: 2024-04-05 date: 2024-07-05 date: 2024-10-05 date: 2024-04-02 date: 2024-04-02 name: Ataturk University class: OTHER briefSummary: The study was planned as prospective and randomized. For the study, patients will be randomized into two groups as unilateral and bilateral suture sacro-hysteropexy operations. conditions: Pelvic Organ Prolapse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: unilateral suture sacro-hysteropexy name: bilateral suture sacro-hysteropexy measure: anatomical success of the operations measure: evaluation of the sexual functions of the patients sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Atatürk University status: RECRUITING city: Erzurum state: Palandöken country: Turkey name: Gamze Nur Cimilli Senocak role: CONTACT phone: +905305880025 email: [email protected] lat: 39.90861 lon: 41.27694 hasResults: False
<|newrecord|> nctId: NCT06341075 id: KY2024-053-02 briefTitle: Real-World Study of Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Drug-resistant Epilepsy overallStatus: ENROLLING_BY_INVITATION date: 2024-03-14 date: 2025-03-14 date: 2026-03-14 date: 2024-04-02 date: 2024-04-02 name: Beijing Tiantan Hospital class: OTHER briefSummary: The goal of the real-world study is to evaluate the long-term seizure control outcomes, postoperative complications, long term impact on cognitive, memory function outcomes, quality-of-life measures, and healthcare resource utilization of magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) on patients with drug-resistant epilepsy (DRE). conditions: Drug Resistant Epilepsy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) measure: Seizure-freedom rate measure: Seizure frequency reduction measure: ILAE classification of outcome measure: Seizure severity measure: Rate of mild complications measure: Cognitive function evaluation measure: Memory function evaluation measure: The quality of life measure: Length of hospital stay measure: Rate of reoperations measure: Rate of antiepileptic drug reduction or withdrawn sex: ALL minimumAge: 12 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tiantan Hospital city: Beijing state: Beijing zip: 100070 country: China lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06341062 id: M2024078 briefTitle: The Application of Contrast-enhanced Ultrasound in Acute Kidney Injury in ICU overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-06-30 date: 2026-06-30 date: 2024-04-02 date: 2024-04-02 name: Peking University Third Hospital class: OTHER briefSummary: The goal of this study is to quantitatively assess renal microcirculation changes by contrast-enhanced ultrasound and to obtain systemic hemodynamic information by ultrasound Doppler at the same time, to analyze the relationship between renal microcirculation changes and systemic hemodynamic changes, and to explore its predictive value in renal function recovery in patients with critical acute kidney injury. The main questions it aims to answer are:
1. To explore the quantitative parameters of contrast-enhanced ultrasound which can reflect the changes of renal microcirculation.
2. To explore the relationship between renal microcirculation and systemic hemodynamics.
3. To explore the value of renal microflow changes quantitatively evaluated by contrast-enhanced ultrasound in predicting renal function recovery. conditions: Intensive Care Unit conditions: Acute Kidney Injury conditions: Ultrasound studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 44 type: ESTIMATED name: Renal microcirculation quantitatively assessed by Contrast-enhanced ultrasound measure: Serum creatinine values and/or urine output sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ultrasound Diagnosis, Peking University Third Hospital city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06341049 id: 2024-03/14 briefTitle: Effect of Three Different Postcesarean Analgesic Techniques on QbsQor-10 Score: Prospective, Randomized Trial overallStatus: RECRUITING date: 2024-03-12 date: 2024-06-12 date: 2025-09-12 date: 2024-04-02 date: 2024-04-02 name: Ataturk University class: OTHER briefSummary: The aim of this study is to evaluate the effects of three different postsesarean analgesia techniques, including instillation of local anesthetic into the peritoneum with infiltration into all layers of the anterior abdominal wall, intrathecal morphine injection with local anesthetic, and quadrotus lumborum type 1 block, on the postoperative recovery of women using the ObsQoR-10 score.. conditions: Postoperative Recovery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Intraperitoneal local anasthetic application + local anesthetic wound infiltration name: Intrathecal morphine application name: Quadratus lumborum block tip 1 application measure: obstetric quality of recovery-10 (ObsQoR-10) scores of parturient at the 24th and 48th postoperative hours sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Ataturk University status: RECRUITING city: Erzurum state: Palandoken country: Turkey name: Aysenur Dostbil role: CONTACT phone: +905333676696 email: [email protected] lat: 39.90861 lon: 41.27694 hasResults: False
<|newrecord|> nctId: NCT06341036 id: Thrombocytosis in Children briefTitle: Aetiology And Outcome Of Children With Thrombocytosis Admitted to Assiut University Children Hospital overallStatus: NOT_YET_RECRUITING date: 2024-07-15 date: 2025-03-03 date: 2026-03-03 date: 2024-04-02 date: 2024-04-02 name: Assiut University class: OTHER briefSummary: The primary Aim :to determine the etiology of thrombocytosis in children and frequency, outcome of thrombocytosis in Children. conditions: Thrombocytosis in Children studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 42 type: ESTIMATED measure: Aetiology And Outcome Of children with Thrombocytosis admitted to Assiut University children hospital sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06341023 id: 2023-1430 briefTitle: Functional Balance Intervention in Multiple Sclerosis acronym: FBIinMS overallStatus: NOT_YET_RECRUITING date: 2024-04-14 date: 2026-01-09 date: 2027-01-09 date: 2024-04-02 date: 2024-04-03 name: University of Illinois at Chicago class: OTHER briefSummary: This project involves two sub-parts:
Study 1: Effect of lab-based Functional Balance Intervention (FBI) for physical and cognitive symptoms of Multiple Sclerosis.
Study 2: Feasibility of home-based FBI for physical and cognitive symptoms of Multiple Sclerosis.
Each study involves a 2-arm, Phase-1, randomized controlled clinical trial to evaluate the effect of FBI on physical, cognitive function, and daily living among people with MS (PwMS). Study 1 is conducted in a lab setting, while Study 2 is conducted at home with additional safety measures. A total of 150 people with multiple sclerosis will be recruited and telephone screened, with an expected enrollment of 120 (60 per phase). After in-person screening, 96 eligible participants (48 per phase) will undergo pre-training assessment and randomization into FBI or Stretching groups. Training sessions will occur twice a week for four months. Anticipating a 15-17% attrition rate, the target sample size is 80 (40 per phase) for completion of the study. Post-training assessments will be conducted after four months to evaluate FBI's impact on physical and cognitive functions. This evidence-based protocol, previously successful with neurological and older adult populations, intends to provide a low-cost, safe, and effective intervention for PwMS in clinical and community settings, including rural areas. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Subjects will be blinded to group existence and assignment and outcome assessors will be blinded to group assignment whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Functional Balance Intervention name: Stretching measure: Change in physical function measure: Change in cognitive function measure: Change in dual task balance performance measure: Change in dual task gait performance measure: Change in measured community mobility measure: Change in self-reported community mobility measure: Change in self-reported quality of Life measure: Change in walking performance measure: Change in walking speed measure: Change in balance confidence measure: Change in functional independence sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Illinois at Chicago city: Chicago state: Illinois zip: 60612 country: United States name: Tanvi Bhatt, PhD role: CONTACT phone: 312-355-4443 email: [email protected] name: Rudri Purohit, MS role: CONTACT phone: 3128773640 email: [email protected] lat: 41.85003 lon: -87.65005 hasResults: False
<|newrecord|> nctId: NCT06341010 id: The Role of Angiojet Rheolytic briefTitle: The Role of Angiojet Rheolytic Thrombectomy in The Management of Iliofemoral Deep Venous Thrombosis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-01-01 date: 2026-09-01 date: 2024-04-02 date: 2024-04-02 name: Abdelrahman Ibrahim Sayed Mohamed Abdalla class: OTHER briefSummary: The aim of this study is to evaluate the efficacy and safety of rheolytic thrombectomy in restoring venous patency DVT, periprocedural complications and development of PTS after tratment of iliofemoral DVT. conditions: Iliofemoral Deep Vein Thrombosis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: Angiojet Rheolytic Thrombectomy in The Management of Iliofemoral Deep Venous Thrombosis measure: Technical success measure: Incidence of PTS sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06340997 id: Mitral Stenosis briefTitle: Impact of Percutaneous Transvenous Mitral Commissurotomy on The Left Atrial Appendage Function in Patients With Mitral Stenosis. overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-10-01 date: 2027-08-01 date: 2024-04-02 date: 2024-04-02 name: Assiut University class: OTHER briefSummary: • Evaluation of the effect of PTMC on LAA function by TEE at least one month after the procedure and its effectiveness in prevention of thrombi formation and cerebrovascular complications. conditions: Mitral Stenosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 25 type: ESTIMATED name: Transesophageal echocardiography measure: Impact of Percutaneous Transvenous Mitral Commissurotomy on The Left Atrial Appendage Function in Patients with Mitral Stenosis. measure: Prevention of left atrial appendage thrombus. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06340984 id: sICAM-1 in acne vulgaris briefTitle: Serum Intercellular Adhesion Molecule -1 in Acne Vulgaris Patients : Effect of Montelukast overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-11 date: 2025-02 date: 2024-04-02 date: 2024-04-03 name: South Valley University class: OTHER briefSummary: The aim of this study is to:
1. Evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level in acne vulgaris and compare it to control group
2. Evaluate its role in acne pathogenesis and its correlation with acne vulgaris severity
3. Evaluate the effect of Montelukast on serum (sICAM-1) level in acne vulgaris conditions: Acne Vulgaris studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Montelukast 10 Mg Oral Tablet measure: Evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level in acne vulgaris (moderate -severe ) measure: Montelukast in treatment of acne vulgaris patients sex: ALL minimumAge: 15 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06340971 id: 331247 briefTitle: Air Pollution and Pregnancy acronym: PTB overallStatus: RECRUITING date: 2024-09-01 date: 2029-08-31 date: 2029-08-31 date: 2024-04-02 date: 2024-04-02 name: Queen Mary University of London class: OTHER name: University College London Hospitals briefSummary: We are an inter-disciplinary team of UK scientists with expertise in obstetrics, women's and child health, epidemiology, climate science, inflammation, computational modelling, machine learning and artificial intelligence. Together we have a long history with existing strengths underlying preterm birth research that crosses multiple disciplines and an excellent track record of publications and awards leading research in preterm birth.
We aim to develop and validate a deep learning model to predict the risk of preterm birth and other adverse pregnancy outcomes using data from EPIC electronic health records at University College London Hospital Trust (UCLH) for a cohort of 18000 patients. We will obtain corresponding data on exposure to ambient pollution using non-identifiers for postcode (area) and date of delivery (month). The model will review the temporal sequence of events within a patient's medical history and current pregnancy, identifying significant interactions and will predict the risk of preterm birth. It will also determine the threshold and gestation at which pollution exposure has the greatest impact. conditions: Premature Birth studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 200000 type: ESTIMATED name: Policy measure: Machine learning model to predict the risk of preterm birth and adverse birth outcomes measure: Machine learning model to predict how air quality increases the risk of preterm birth and adverse birth outcomes sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tina Chowdhury status: RECRUITING city: London zip: E14NS country: United Kingdom name: Tina Chowdhury role: CONTACT phone: 0207882 phoneExt: 7560 email: [email protected] name: Rhona Atkins role: CONTACT phone: 0207882 phoneExt: 7272 email: [email protected] lat: 51.50853 lon: -0.12574 facility: Anna David status: RECRUITING city: London zip: NW1 2PG country: United Kingdom name: Yaa Acheampong role: CONTACT phone: 020 3447 phoneExt: 6164 email: [email protected] name: Anna David role: CONTACT phone: 0203 447 phoneExt: 9400 email: [email protected] lat: 51.50853 lon: -0.12574 hasResults: False
<|newrecord|> nctId: NCT06340958 id: CLE100-MDD-202 briefTitle: A Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder acronym: SOLEO overallStatus: RECRUITING date: 2024-03-18 date: 2025-07-11 date: 2026-01-10 date: 2024-04-02 date: 2024-04-10 name: Clexio Biosciences Ltd. class: INDUSTRY briefSummary: The study is a Phase 2, double-blind, randomized, placebo-controlled study in Major Depressive Disorder (MDD) participants with an inadequate response to standard antidepressants The objective of the study is to assess CLE-100 (oral esketamine) for the treatment of MDD in participants currently treated with an oral antidepressant medication and who have an inadequate response to at least 2 antidepressants. conditions: Adjunctive Treatment of Major Depressive Disorder (MDD) studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: CLE-100 name: Placebo measure: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) score measure: Change from Baseline in the Clinical Global Impression - Severity (CGI-S) measure: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) score measure: Safety Outcomes: Assessment of the safety and tolerability of CLE-100 compared to placebo sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Site 105 status: RECRUITING city: Lauderhill state: Florida zip: 33319 country: United States lat: 26.14036 lon: -80.21338 facility: Clinical SIte 112 status: RECRUITING city: Miami Lakes state: Florida zip: 33016 country: United States lat: 25.90871 lon: -80.30866 facility: Clinical Site 118 status: RECRUITING city: Atlanta state: Georgia zip: 30030 country: United States lat: 33.749 lon: -84.38798 facility: Clinical Site 128 status: RECRUITING city: Marlton state: New Jersey zip: 08054 country: United States lat: 39.89122 lon: -74.92183 facility: Clinical Site 101 status: RECRUITING city: Toms River state: New Jersey zip: 08755 country: United States lat: 39.95373 lon: -74.19792 hasResults: False
<|newrecord|> nctId: NCT06340945 id: S2023-761-01 briefTitle: The Outcomes of Ultrasound-guided Thermal Ablation for Benign Thyroid Nodules overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-12-31 date: 2029-12-31 date: 2024-04-02 date: 2024-04-02 name: Chinese PLA General Hospital class: OTHER briefSummary: 1. To evaluate the clinical outcomes of ultrasound-guided thermal ablationfor the treatment of benign thyroid nodules;
2. To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of benign thyroid nodules conditions: Thyroid Nodules studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 1500 type: ESTIMATED name: ultrasound-guided thermal ablation measure: volume reduction rate measure: rate of nodule regrowth measure: rate of complications measure: cosmetic score measure: symptom score measure: vital volume measure: total volume sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06340932 id: CRS-119 (Pro00077191) briefTitle: Impact of Opioid Avoidance Protocol for ACL Reconstruction overallStatus: NOT_YET_RECRUITING date: 2024-03-28 date: 2024-08-15 date: 2024-10-01 date: 2024-04-02 date: 2024-04-02 name: Matthew Varacallo class: OTHER name: Pacira Biosciences briefSummary: This is a prospective, quasi-experimental, cohort study comparing patients treated with one of two postoperative pain management protocols. The two protocols assessed will be the current standard of care protocol for ACLR postoperative pain control utilized by Dr. Matthew Varacallo and then an opioid avoidance protocol that is planned to be implemented on the Spring of 2024. The study is voluntary, however all patients will be treated with either of the two protocols depending on their date of surgery. This study will include patients aged 15 years and older who consent to the participation in the study. Patients will be identified utilizing the operative surgeon's appointment calendar and will be screened and offered inclusion in the study if applicable at their pre-operative visit. Data will be collected via patient medication and pain diary, phone call, and clinician administration of standardized outcome questionnaires. Patients will be included in the standard of care group if ACLR is performed prior to the change in protocol in the Spring of 2024 or the opioid avoidance group if performed after the protocol change.
The primary objective of this study is to evaluate the effect of the opioid avoidance protocol on opioid use in MME from POD0-7 after ACLR compared to the current standard of care pain management protocol.
Secondary objectives are to:
* evaluate the effects of an opioid avoidance protocol on the daily average NRS pain scores from POD0-7
* evaluate the effects of an opioid avoidance protocol on the daily worst NRS pain score from POD0-7
* evaluate the ability to recover opioid free through 7, 30, and 60 days
* evaluate the QoR-15 scores on POD2
* assess the number of opioid prescriptions required by patients in the 60 day recover period
* assess KOOS pain and symptom scales at 8 weeks post-operatively between groups. conditions: ACL Tear conditions: Post Operative Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Iovera name: Celecoxib name: Acetaminophen name: Oxycodone name: Tramadol name: Bupivacaine Hydrochloride name: Acetaminophen 500Mg Cap measure: Opioid consumption from POD0-POD7 measure: Average daily pain (NRS) measure: Average daily worst pain (NRS) measure: KOOS Pain Subscale Score measure: Quality of Recovery-15 measure: Pittsburgh Rehabilitation Participation Scale Score sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Penn Highlands Dubois city: DuBois state: Pennsylvania zip: 15801 country: United States name: Samantha Morgan, DAT role: CONTACT phone: 814-496-3141 email: [email protected] name: Christopher Varacallo role: SUB_INVESTIGATOR name: Samantha Morgan role: SUB_INVESTIGATOR lat: 41.11923 lon: -78.76003 hasResults: False
<|newrecord|> nctId: NCT06340919 id: 1406014978-241 briefTitle: Hearing Aid Algorithms for Sudden Sounds overallStatus: ENROLLING_BY_INVITATION date: 2024-02-21 date: 2024-09-30 date: 2025-05-31 date: 2024-04-02 date: 2024-04-02 name: Purdue University class: OTHER name: Oticon briefSummary: This study explores the impact of hearing aid settings for managing sudden sounds on speech comprehension and recall in individuals with hearing loss. Participants will undergo a comprehensive audiological evaluation, case history, and cognitive assessments. Subsequently, they will participate in listening experiments designed to measure sentence recognition, storage, and retrieval under various sudden sound reduction conditions recorded through a hearing aid. The experiment will be complemented by subjective preference ratings to identify participant comfort and listening clarity associated with different sudden sound reduction settings. conditions: Hearing Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Sudden Sound Reduction Setting measure: Speech recognition measure: Recall measure: Preference sex: ALL minimumAge: 18 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Purdue University city: West Lafayette state: Indiana zip: 47907 country: United States lat: 40.42587 lon: -86.90807 hasResults: False
<|newrecord|> nctId: NCT06340906 id: 4573 id: UCI 23-29 type: OTHER domain: CFCCC briefTitle: Electroacupuncture in Symptom Management After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-11-15 date: 2026-01-30 date: 2024-04-02 date: 2024-04-03 name: University of California, Irvine class: OTHER briefSummary: The investigators are conducting this research study is to evaluate the feasibility (recruitment, compliance, safety, and acceptance) of using electroacupuncture (EA) to manage complex symptoms such as pain, nausea/vomiting, diarrhea, and insomnia in patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy. Additionally, the investigators are aiming to determine the effectiveness of EA in reducing these symptoms, and to examine how EA impacts important biomarkers, or proteins in the blood, that can be used as indicators or signs of these symptoms. conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a single-arm, prospective pilot/feasibility study. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Electroacupuncture measure: Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Number of Patients Recruited measure: Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Patient Recruitment Rate measure: Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Reasons for Abstaining from Participation measure: Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Recruitment Duration measure: Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Number of Completed Electroacupuncture Sessions measure: Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Proportion of Completed Electroacupuncture Sessions measure: Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - EORTC QLQ-C30 measure: Efficacy of EA in managing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - EORTC QLQ-C30 measure: Efficacy of EA in managing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - FACT-Cog version 3 measure: Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - FACT-Cog version 3 measure: Biomarkers - Plasma (pg/mL) measure: Vital Signs - Blood Pressure (mmHg) measure: Vital Signs - Heart Rate (bpm) measure: Vital Signs - Body Temperature (C) measure: Vital Signs - Respiration Rate (breaths/minute) measure: Vital Signs - Oxygen Saturation Rate (%) measure: Height (feet and inches) measure: Weight (kg) measure: Incidence of Treatment-Emergent Adverse Events - Safety Monitoring measure: Biomarkers - Plasma BDNF (pg/ml) measure: Biomarkers - Plasma cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-alpha, pg/mL) measure: Mitochondrial DNA content sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCI Health Susan Samueli Integrative Health Institute city: Irvine state: California zip: 92697 country: United States name: Matthew Heshmatipour, BSc role: CONTACT email: [email protected] lat: 33.66946 lon: -117.82311 hasResults: False
<|newrecord|> nctId: NCT06340893 id: 76117 briefTitle: Exercise Training in Children With Communication Impairments overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-31 date: 2024-08-31 date: 2024-04-02 date: 2024-04-02 name: Marquette University class: OTHER name: University of Arizona briefSummary: This clinical trial study has two goals. The first goal is to establish fitness levels, participation in physical activities, and fine/gross motor abilities for children with development language disorder (DLD). DLD occurs in 1/13 children and children with DLD often have poorer fine/gross motor skills than those with typical development. The second goal is to determine whether physical exercise helps children with DLD and typical development to learn better and improve fitness and fine/gross motor abilities more than participating in restful play activities.
All children (DLD and typically developing) will undergo communication, fine/gross motor and fitness testing. Children will be randomly assigned to participate in an exercise program (n =20) or to a restful play program (n = 20). Both programs will take place 3x/week for 6 weeks and children will only participate in one of the two programs.
Children in the exercise program will do activities to train cardiovascular fitness, agility, balance, strength, and endurance while children in the restful play condition will do things like play with legos and color.
Researchers will compare changes in learning tasks and fitness levels for children (DLD and typically developing) who participated in the exercise program vs. restful play program. conditions: Developmental Language Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to the exercise intervention group or to the restful play (sham) condition. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcome assessors will be blinded to group and will be different to those conducting the interventions. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Exercise name: Restful Play measure: Changes to cognitive-linguistic performance: Word learning accuracy (% correct) measure: Changes to cognitive-linguistic performance: Reaction time on the Serial Reaction Time task (milliseconds) measure: Fitness: Maximum oxygen consumption (VO2 max) (ml/kg/min) measure: Motor Performance (scaled scores) measure: Enjoyment of Intervention sex: ALL minimumAge: 6 Years maximumAge: 8 Years stdAges: CHILD facility: Marquette U city: Milwaukee state: Wisconsin zip: 53201 country: United States name: Jenya Iuzzini-Seigel, PhD role: CONTACT phone: 585-489-4683 email: [email protected] lat: 43.0389 lon: -87.90647 hasResults: False
<|newrecord|> nctId: NCT06340880 id: SAPB briefTitle: Serratus Anterior Plane Block, Ultrasound vs Anatomical Landmark Guided. overallStatus: RECRUITING date: 2024-03 date: 2024-05 date: 2024-05 date: 2024-04-02 date: 2024-04-02 name: Menoufia University class: OTHER briefSummary: This prospective, double-blinded randomized controlled trial aims to compare the efficacy of the serratus anterior plane block (SAPB) ultrasound guided versus anatomical landmark guided for gynecomastia surgery. And to detect if the anatomical landmark technique is inferior or not to the ultrasound guided technique. We hypothesize that anatomical landmark guided SAPB is not inferior to ultrasound guided SAPB. conditions: Serratus Anterior Plane Block studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Serratus anterior plane block measure: visual numerical rating score (NRS) measure: first call of analgesia measure: incidence of complications measure: patient satisfaction sex: MALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Menoufia University Hospitals status: RECRUITING city: Shibīn Al Kawm state: Menoufia country: Egypt name: Menoufia U Hospitals role: CONTACT phone: +20482228303 email: [email protected] lat: 30.55258 lon: 31.00904 hasResults: False
<|newrecord|> nctId: NCT06340867 id: 30723 briefTitle: Intraoral Scanner With and Without Orthodontic Brackets overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-01 date: 2024-03-24 date: 2024-04-01 date: 2024-04-02 date: 2024-04-02 name: Cairo University class: OTHER briefSummary: this study aim to evaluate the effect of two different intraoral scanners on the scanning Quality and Time in Patients With/Without Orthodontic Brackets conditions: Intra-oral Scanner conditions: Adolescent Behavior studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 10 type: ACTUAL name: CEREC primescan intra-oral scanner measure: The effect of the different scanning techniques on the scanning quality and time measure: The effect of the bracket presence on the scanning quality sex: ALL minimumAge: 14 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Faculty of Dentistry, Cairo university city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<|newrecord|> nctId: NCT06340854 id: NN1436-7724 id: U1111-1292-6151 type: OTHER domain: World Health Organization (WHO) id: 2023-506084-34 type: OTHER domain: European Medical Agency (EMA) briefTitle: A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes overallStatus: RECRUITING date: 2024-04-19 date: 2025-05-16 date: 2025-06-20 date: 2024-04-02 date: 2024-04-25 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months. conditions: Diabetes, Type 2 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 404 type: ESTIMATED name: Insulin icodec name: Insulin glargine measure: Change in glycated hemoglobin (HbA1c) measure: Change in time in range 3.9-10.0 millimoles per litre (mmol/L) (70-180 milligrams per decilitre (mg/dL)) measure: Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction measure: Number of severe hypoglycaemic episodes (level 3) measure: Number of clinically significant hypoglycaemic episodes (level 2) (less than (<) 3.0 millimoles per litre (mmol/L) (54 mg/dL), confirmed by blood glucose (BG) meter) measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL),confirmed by BG meter) or severe hypoglycaemic episodes (level 3) measure: Time spent < 3.0 mmol/L (54 mg/dL) measure: Change in time spent > 10.0 mmol/L (180 mg/dL) measure: Mean weekly insulin dose measure: Change in body weight sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Advanced Investigative Medicine, Inc. status: RECRUITING city: Hawthorne state: California zip: 90250 country: United States lat: 33.9164 lon: -118.35257 facility: Scripps Whittier Diabetes Inst status: RECRUITING city: La Jolla state: California zip: 92037 country: United States lat: 32.84727 lon: -117.2742 facility: Clinical Trials Research status: RECRUITING city: Lincoln state: California zip: 95648 country: United States lat: 38.89156 lon: -121.29301 facility: Northeast Research Institute of Florida status: RECRUITING city: Fleming Island state: Florida zip: 32003 country: United States lat: 30.0933 lon: -81.71898 facility: South Broward Research LLC status: RECRUITING city: Miramar state: Florida zip: 33027 country: United States lat: 25.98731 lon: -80.23227 facility: Endo Res Solutions Inc status: RECRUITING city: Roswell state: Georgia zip: 30076 country: United States lat: 34.02316 lon: -84.36159 facility: Cotton-Oneill Diabetes and End status: RECRUITING city: Topeka state: Kansas zip: 66606-2806 country: United States lat: 39.04833 lon: -95.67804 facility: International Diabetes Center status: RECRUITING city: Minneapolis state: Minnesota zip: 55416 country: United States lat: 44.97997 lon: -93.26384 facility: Jefferson City Medical Group, PC status: RECRUITING city: Jefferson City state: Missouri zip: 65109 country: United States lat: 38.5767 lon: -92.17352 facility: Univ of Nebraska Medical CTR status: NOT_YET_RECRUITING city: Omaha state: Nebraska zip: 68198-3020 country: United States lat: 41.25626 lon: -95.94043 facility: Palm Research Center Inc-Vegas status: RECRUITING city: Las Vegas state: Nevada zip: 89148 country: United States lat: 36.17497 lon: -115.13722 facility: Southern NH Diabetes and Endo_Nashua status: RECRUITING city: Nashua state: New Hampshire zip: 03060 country: United States lat: 42.76537 lon: -71.46757 facility: PharmQuest Life Sciences LLC status: RECRUITING city: Greensboro state: North Carolina zip: 27408 country: United States lat: 36.07264 lon: -79.79198 facility: Accellacare Wilmington status: RECRUITING city: Wilmington state: North Carolina zip: 28401 country: United States lat: 34.22573 lon: -77.94471 facility: Trial Management Associates status: RECRUITING city: Myrtle Beach state: South Carolina zip: 29572 country: United States lat: 33.68906 lon: -78.88669 facility: Amarillo Medical Specialists status: RECRUITING city: Amarillo state: Texas zip: 79106 country: United States lat: 35.222 lon: -101.8313 facility: Velocity Clinical Res-Dallas status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States lat: 32.78306 lon: -96.80667 facility: Victorium Clinical Research status: RECRUITING city: Houston state: Texas zip: 77024 country: United States lat: 29.76328 lon: -95.36327 facility: PlanIt Research, PLLC status: RECRUITING city: Houston state: Texas zip: 77079 country: United States lat: 29.76328 lon: -95.36327 facility: Chrysalis Clinical Research status: RECRUITING city: Saint George state: Utah zip: 84790 country: United States lat: 37.10415 lon: -113.58412 facility: Rainier Clin Res Ctr Inc status: RECRUITING city: Renton state: Washington zip: 98057 country: United States lat: 47.48288 lon: -122.21707 facility: "Medical Center Viva Feniks" Ood status: RECRUITING city: Dobrich zip: 9300 country: Bulgaria lat: 43.56667 lon: 27.83333 facility: MHAT "Knyaginya Klementina" -Sofia EAD status: RECRUITING city: Sofia zip: 1233 country: Bulgaria lat: 42.69751 lon: 23.32415 facility: UMHAT Aleksandrovska status: RECRUITING city: Sofia zip: 1431 country: Bulgaria lat: 42.69751 lon: 23.32415 facility: Medical Institute of Ministry of interior status: RECRUITING city: Sofia zip: 1606 country: Bulgaria lat: 42.69751 lon: 23.32415 facility: InnoDiab Forschung GmbH status: RECRUITING city: Essen zip: 45136 country: Germany lat: 51.45657 lon: 7.01228 facility: Institut für Diabetesforschung GmbH Münster - Dr. med. Rose status: NOT_YET_RECRUITING city: Münster zip: 48145 country: Germany lat: 51.96236 lon: 7.62571 facility: MedicalCenter am Clemenshospital status: NOT_YET_RECRUITING city: Münster zip: 48153 country: Germany lat: 51.96236 lon: 7.62571 facility: RED-Institut für medizinische Forschung und Fortbildung GmbH status: RECRUITING city: Oldenburg in Holstein zip: 23758 country: Germany lat: 54.29576 lon: 10.90156 facility: Institut für Diabetesforschung Osnabrück status: NOT_YET_RECRUITING city: Osnabrück zip: 49080 country: Germany lat: 52.27264 lon: 8.0498 facility: Zentrum für klinische Studien Allgäu Oberschwaben status: NOT_YET_RECRUITING city: Wangen zip: 88239 country: Germany lat: 48.72933 lon: 9.61175 facility: Lifecare Hospital and Research Centre status: NOT_YET_RECRUITING city: Bangalore state: Karnataka zip: 560092 country: India lat: 12.97194 lon: 77.59369 facility: Belgaum Diabetes Centre status: NOT_YET_RECRUITING city: Belgaum state: Karnataka zip: 590001 country: India lat: 15.85212 lon: 74.50447 facility: Manipal Hospital, Old Airport Road, Bengaluru status: NOT_YET_RECRUITING city: Bengaluru state: Karnataka zip: 560017 country: India lat: 12.97194 lon: 77.59369 facility: Amrita Institute Of Medical Sciences & Research Centre status: NOT_YET_RECRUITING city: Kochi state: Kerala zip: 682041 country: India lat: 9.93988 lon: 76.26022 facility: Seth GS Medical College & KEM Hospital status: NOT_YET_RECRUITING city: Mumbai state: Maharashtra zip: 400012 country: India lat: 19.07283 lon: 72.88261 facility: Grant Medical Foundation Ruby Hall Clinic status: NOT_YET_RECRUITING city: Pune state: Maharashtra zip: 411001 country: India lat: 18.51957 lon: 73.85535 facility: Malla Reddy Narayana Multispeciality Hospital status: NOT_YET_RECRUITING city: Hyderabad state: Telangana zip: 500055 country: India lat: 17.38405 lon: 78.45636 facility: Gandhi Hospital & Medical college status: NOT_YET_RECRUITING city: Hyderabad state: Telengana zip: 500003 country: India lat: 17.38405 lon: 78.45636 facility: Government Institute of Medical Sciences status: NOT_YET_RECRUITING city: Noida state: Uttar Pradesh zip: 201310 country: India lat: 28.58 lon: 77.33 facility: Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh status: NOT_YET_RECRUITING city: Chandigarh zip: 160012 country: India lat: 30.73629 lon: 76.7884 facility: Christian Medical College and Hospital status: NOT_YET_RECRUITING city: Ludhiana zip: 141008 country: India lat: 30.91204 lon: 75.85379 facility: Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) status: NOT_YET_RECRUITING city: Puducherry zip: 605006 country: India lat: 11.93381 lon: 79.82979 facility: Heiwadai Hospital status: RECRUITING city: Miyazaki-shi state: Miyazaki zip: 880-0034 country: Japan lat: 31.91667 lon: 131.41667 facility: Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology status: NOT_YET_RECRUITING city: Shinjuku-ku state: Tokyo zip: 1600023 country: Japan lat: 35.2946 lon: 139.57059 facility: Futata Tetsuhiro Clinic Meinohama status: RECRUITING city: Fukuoka-shi, Fukuoka zip: 819-0006 country: Japan lat: 33.6 lon: 130.41667 facility: Oyama East Clinic status: RECRUITING city: Tochigi zip: 323-0022 country: Japan lat: 36.38333 lon: 139.73333 facility: Noritake Clinic status: RECRUITING city: Ushiku-shi, Ibaraki zip: 300-1207 country: Japan facility: Uniwersytecki Szpital Kliniczny w Opolu status: RECRUITING city: Opole state: Opolskie zip: 45-401 country: Poland lat: 50.67211 lon: 17.92533 facility: Uniwersytecki Szpital Kliniczny w Opolu status: NOT_YET_RECRUITING city: Opole state: Opolskie zip: 45-401 country: Poland lat: 50.67211 lon: 17.92533 facility: NZOZ Vita-Diabetica Malgorzata Buraczyk status: RECRUITING city: Bialystok state: Podlaskie Voivodeship zip: 15-879 country: Poland lat: 53.13333 lon: 23.16433 facility: NZOZ Vita-Diabetica Malgorzata Buraczyk status: NOT_YET_RECRUITING city: Bialystok state: Podlaskie Voivodeship zip: 15-879 country: Poland lat: 53.13333 lon: 23.16433 facility: NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska status: RECRUITING city: Bialystok state: Podlaskie zip: 15-435 country: Poland lat: 53.13333 lon: 23.16433 facility: Centrum Medyczne Pratia Gdynia status: NOT_YET_RECRUITING city: Gdynia state: Pomorskie zip: 81-338 country: Poland lat: 54.51889 lon: 18.53188 facility: Centrum Medyczne Pratia Katowice status: RECRUITING city: Katowice zip: 40-081 country: Poland lat: 50.25841 lon: 19.02754 facility: Centrum Medyczne Pratia Katowice status: NOT_YET_RECRUITING city: Katowice zip: 40-081 country: Poland lat: 50.25841 lon: 19.02754 facility: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji status: RECRUITING city: Warszawa zip: 02-507 country: Poland lat: 52.22977 lon: 21.01178 facility: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji status: NOT_YET_RECRUITING city: Warszawa zip: 02-507 country: Poland lat: 52.22977 lon: 21.01178 facility: Trialmed CRS status: RECRUITING city: Piotrków Trybunalski state: Łódzkie zip: 97-300 country: Poland lat: 51.40547 lon: 19.70321 facility: Advanced Clinical Research LLC status: RECRUITING city: Bayamon zip: 00959 country: Puerto Rico lat: 18.39856 lon: -66.15572 facility: Manati Ctr For Clin Research status: RECRUITING city: Manati zip: 00674 country: Puerto Rico lat: 18.42745 lon: -66.49212 facility: Hemant Makan status: NOT_YET_RECRUITING city: Johannesburg state: Gauteng zip: 1827 country: South Africa lat: -26.20227 lon: 28.04363 facility: Dr Moosa's Rooms status: NOT_YET_RECRUITING city: Lenasia state: Gauteng zip: 1827 country: South Africa lat: -26.32052 lon: 27.83564 facility: Botho ke Bontle Health Services status: NOT_YET_RECRUITING city: Pretoria state: Gauteng zip: 0184 country: South Africa lat: -25.74486 lon: 28.18783 facility: Dr Mahesh Duki Research And Trial Site status: NOT_YET_RECRUITING city: Durban state: KwaZulu Natal zip: 4339 country: South Africa lat: -29.8579 lon: 31.0292 facility: Dr A Amod status: NOT_YET_RECRUITING city: Durban state: KwaZulu-Natal zip: 4092 country: South Africa lat: -29.8579 lon: 31.0292 facility: Dr MB Moosa's Practice status: NOT_YET_RECRUITING city: Durban state: KwaZulu-Natal zip: 4092 country: South Africa lat: -29.8579 lon: 31.0292 facility: Hospital de Basurto status: NOT_YET_RECRUITING city: Bilbao state: Vizcaya zip: 48013 country: Spain lat: 43.26271 lon: -2.92528 facility: Hospital Clinic i Provincial status: RECRUITING city: Barcelona zip: 08036 country: Spain lat: 41.38879 lon: 2.15899 facility: ABS La Roca del Vallés status: RECRUITING city: La Roca del Vallés zip: 08430 country: Spain lat: 41.58333 lon: 2.33333 facility: Hospital Clínico Virgen de la Victoria status: RECRUITING city: Málaga zip: 29010 country: Spain lat: 36.72016 lon: -4.42034 facility: Hospital Quirón status: NOT_YET_RECRUITING city: Pozuelo de Alarcón zip: 28223 country: Spain lat: 40.43293 lon: -3.81338 hasResults: False
<|newrecord|> nctId: NCT06340841 id: LEMURS SSI 24 briefTitle: LEMURS SSI: Evaluation of Behavioral Incentives acronym: LEMURSSI overallStatus: RECRUITING date: 2024-02-12 date: 2024-05-31 date: 2028-05-31 date: 2024-04-02 date: 2024-04-02 name: University of Vermont class: OTHER briefSummary: The goal of this substudy is to determine if a brief single-session-intervention (SSI) coupled with different incentive strategies to support engaging in wellness-related activities. conditions: Incentives studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Participants will be randomized to one of four incentive conditions and receive rewards based on their completion of such activities. There are two main factors (Recipient x Restoration) that will create four distinct groups. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 200 type: ESTIMATED name: Personal Incentives name: Personal Restorative Incentives name: Charity Incentives name: Charity Restorative Incentives measure: Activity Completion measure: Depression, Anxiety, Stress Scale - 21 measure: Depression, Anxiety, Stress Scale - 21 measure: Depression, Anxiety, Stress Scale - 21 measure: Warwick-Edinburgh Mental Well-being Scale measure: Oura Ring Sleep Index sex: ALL minimumAge: 18 Years maximumAge: 20 Years stdAges: ADULT facility: University of Vermont status: RECRUITING city: Burlington state: Vermont zip: 05405 country: United States name: Matthew Price, PhD role: CONTACT phone: 802-656-9196 email: [email protected] lat: 44.47588 lon: -73.21207 hasResults: False
<|newrecord|> nctId: NCT06340828 id: 2023-KY-186-01 briefTitle: Washed Microbiota Transplantation Alleviates Diabetic Gastrointestinal Motility Disorders: an Efficacy and Safety Study overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2027-07-20 date: 2027-07-20 date: 2024-04-02 date: 2024-04-03 name: The Second Hospital of Nanjing Medical University class: OTHER briefSummary: The goal of this clinical trial is to learn about effectiveness and safety of washing microbiota transplantation in diabetic gastrointestinal motility disorders participant population. The main questions it aims to answer are:
* The risk factors of diabetic gastrointestinal motility disorders in routine clinical data or biochemical tests.
* The composition of gut microbiota in diabetic gastrointestinal motility disorders patients and potential pathogenic bacteria.
* The efficacy of washing microbiota transplantation in the clinical treatment of diabetic gastrointestinal motility disorders patients and potential factors that may influence treatment outcomes.
* The potential mechanisms of washing microbiota transplantation in treating diabetic gastrointestinal motility disorders patients.
Participants will be collected fasting venous blood and random stool samples before treatment and at week 12 post-treatment, conducting scale assessments before treatment and at weeks 1, 4, and 12 post-treatment. conditions: Diabetic Gastroparesis conditions: Diabetic Gastropathy conditions: Diabetic Gastroenteropathy conditions: Diabetic Gastroparesis Associated With Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Washing Microbiota Transplantation measure: Gastrointestinal Symptom Rating Scale measure: Gut Microbiome Sequencing measure: Gastroparesis Cardinal Symptom Index measure: Composite Autonomic Symptom Score 31 measure: Gastrointestinal Motility measure: Heart Rate Variability measure: Serum Metabolites sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210000 country: China name: Dafa Ding, Professor role: CONTACT phone: +8615850514014 email: [email protected] lat: 32.06167 lon: 118.77778 hasResults: False