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<|newrecord|> nctId: NCT06368362 id: CBM-I001 briefTitle: Cognitive Bias Modification for Interpretation Individuals With Chronic Musculoskeletal Pain overallStatus: COMPLETED date: 2020-11-17 date: 2021-05-01 date: 2021-05-01 date: 2024-04-16 date: 2024-04-16 name: University of Southampton class: OTHER name: Economic and Social Research Council, United Kingdom briefSummary: Cognitive Bias Modification for Interpretation (CBM-I) trains participants to interpret ambiguous information as neutral or benign, rather than interpret it as being related to pain. The goal of this randomised controlled trial was to explore the feasibility and potential clinical benefits of CBM-I in people with chronic pain and also healthy, pain-free individuals. conditions: Chronic Pain conditions: Musculoskeletal Pain Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups of participants (chronic musculoskeletal pain, healthy) were recruited, and within each group participants were randomised to one of two experimental conditions with a 1:1 allocation ratio with a parallel design. Participants with chronic musculoskeletal pain were randomised to benign CBM-I or no CBM-I, and healthy participants were randomised to benign CBM-I or pain-related CBM-I. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants are not informed of the conditioned they are randomised to in this psychological intervention. whoMasked: PARTICIPANT count: 84 type: ACTUAL name: Benign cognitive bias modification for interpretation name: Pain-related cognitive bias modification for interpretation measure: Emotional response to exercise induced pain measure: Emotional response to pain-related images measure: Fear of Pain measure: Anxiety measure: Depression measure: Emotional response to average clinical pain measure: Pain severity measure: Pain interference measure: Pain-related interpretation bias index sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Southampton city: Southampton state: Hampshire zip: SO17 1BJ country: United Kingdom lat: 50.90395 lon: -1.40428 hasResults: False |
<|newrecord|> nctId: NCT06368349 id: 202101771B0 briefTitle: Persistent Lymphopenia in Liver Transplantation and Its Molecular Insights for Hepatocellular Carcinoma overallStatus: COMPLETED date: 2022-03-01 date: 2023-06-21 date: 2023-06-30 date: 2024-04-16 date: 2024-04-18 name: Chang Gung Memorial Hospital class: OTHER briefSummary: A total of 145 Liver transplantation (LT) recipients with hepatocellular carcinoma (HCC) were retrospectively enrolled at Kaohsiung Chang Gung Memorial Hospital between 2006 and 2019. Clinical records from 7 days before LT (pre-LT) to 1 year after LT (post-LT) were analysed. In a prospective study from March 2022 to June 2023, 20 lymphopenia and 25 non-lymphopenia HCC recipients were enrolled, and a phenotypic analysis of peripheral blood lymphocytes was performed using multiparameter flow cytometry. conditions: Lymphopenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 190 type: ACTUAL measure: Persistent lymphopenia predict poor overall survival measure: T cell and its subtype were mainly decrease in pre-LT lymphopenia population of HCC patient measure: Long-term peri-LT lymphopenia HCC recipients is associated with increased sirolimus use and decreased tacrolimus use sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Surgery city: Kaohsiung zip: 833 country: Taiwan lat: 22.61626 lon: 120.31333 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2021-10-20 uploadDate: 2024-04-11T03:02 filename: Prot_SAP_000.pdf size: 422513 hasResults: False |
<|newrecord|> nctId: NCT06368336 id: 994894 briefTitle: Health Related Quality of Life After Intensive Care for Sepsis, a National Cohort Study. overallStatus: COMPLETED date: 2008-01-01 date: 2022-04-01 date: 2022-12-31 date: 2024-04-16 date: 2024-04-17 name: Uppsala University Hospital class: OTHER name: Sepsisfonden briefSummary: The study aims to map the health-related quality of life (HRQoL) after intensive care for Sepsis with the hypothesis that it will be lower than that in the general population. The investigators also want to identify factors that are associated with low HRQoL, to see if those are available for interventions from the health care system and society to improve quality of life after treatment for sepsis in the intensive care unit (ICU). conditions: Sepsis conditions: Septic Shock conditions: Sepsis, Severe studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 210484 type: ACTUAL measure: Health-related Quality of Life after ICU (intensive care unit) treatment with/for sepsis measure: Ability to work before and after ICU (intensive care unit) treatment for Sepsis measure: The burden of disease at ICU (intensive care unit) admittance and after ICU treatment for Sepsis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06368323 id: H-01-24-9931 briefTitle: Effect of Community Choir Singing in People With Chronic Post-stroke Aphasia overallStatus: RECRUITING date: 2024-04-22 date: 2025-12-31 date: 2025-12-31 date: 2024-04-16 date: 2024-04-22 name: University of Ottawa class: OTHER name: Toronto Metropolitan University name: Université de Montréal name: Université du Québec à Trois-Rivières name: University of South Florida briefSummary: The goal of this randomized controled trial is to test the effects of assigning people with chronic post-stroke aphasia to 12 weekly choir sessions, compared to usual care. |
The main question it aims to answer is: |
Does the assignment to a choir singing program causes a beneficial effect on functional communication and language recovery as well as psychosocial outcomes compared to usual care in the rehabilitation of people with chronic post-stroke aphasia? |
Participants will have: |
12 in-person choir-singing sessions (1 session/week, 1,5 h/session, total 18h) conducted by a choir master, and home singing training (3 x 30-minutes-sessions/week, total 18h) conditions: Aphasia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A parallel group randomized trial design with a secondary crossover extension primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcomes will be measured by blinded assessors where possible, using blinded video or audio recordings. whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Choir singing name: Usual care measure: Communication Index measure: Level of confidence in communication measure: Aphasia severity index measure: Speech and language in functional communication measure: Apraxia of speech severity measure: Health related quality of life assessed by the the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) measure: Emotional wellbeing measure: Social participation measure: Generic measure of health measure: Appetence to music measure: Singing voice abilities measure: Voice - Pitch measure: Voice - Maximum Phonation Time measure: Voice - Dynamic range measure: Mood measure: Biosocial indexes measure: Expectations on a 100-scale measure: Satisfaction on a 100-scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of South Florida status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33620 country: United States name: Jennifer Bugos, Ph.D. role: CONTACT email: [email protected] lat: 27.94752 lon: -82.45843 facility: University of Ottawa status: RECRUITING city: Ottawa state: Ontario zip: K1N 6N5 country: Canada name: Anna Zumbansen, PhD role: CONTACT phone: 613-562-5800 phoneExt: 8393 email: [email protected] name: Narges Bayat, Master role: CONTACT phone: 613-562-5800 phoneExt: 8393 email: [email protected] lat: 45.41117 lon: -75.69812 facility: Toronto Metropolitan University status: NOT_YET_RECRUITING city: Toronto state: Ontario zip: M5B 0C3 country: Canada name: Arla Good, Ph.D. role: CONTACT email: [email protected] lat: 43.70011 lon: -79.4163 facility: Université de Montréal status: NOT_YET_RECRUITING city: Montréal state: Quebec zip: H3C 3J7 country: Canada name: Carole Anglade, Ph.D. role: CONTACT email: [email protected] lat: 45.50884 lon: -73.58781 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-04-16 uploadDate: 2024-04-10T11:45 filename: ICF_000.pdf size: 129388 hasResults: False |
<|newrecord|> nctId: NCT06368310 id: R124807 id: 23/WM/0166 type: OTHER domain: NHS Research Ethics Committee Reference briefTitle: FIH Clinical Investigation of Graphene Electrodes for Brain Mapping overallStatus: NOT_YET_RECRUITING date: 2024-05-28 date: 2025-01-31 date: 2025-01-31 date: 2024-04-16 date: 2024-04-16 name: University of Manchester class: OTHER name: Northern Care Alliance NHS Foundation Trust name: European Commission name: Inbrain Neuroelectronics briefSummary: The goal of this clinical investigation of a medical device is to test the safety of graphene based electrodes when used during surgery for resection of brain tumors. The main questions that it aims to answer are: |
* To understand the safety of these new electrodes when used during brain tumor surgery (primary objective); |
* To assess the quality of the brain signals recorded with the new electrodes, their ability to stimulate the brain, how stable their function is over the duration of an operation, and their suitability for use in the operating theatre (secondary objectives). |
Participants will undergo tumor surgery as usual with the study electrodes being tested alongside a standard monitoring system. If they are awake for part of their surgery they may be asked to complete specific tasks such as naming objects from a list modified for the study. They will be monitored subsequently for any complications including undergoing an additional MRI scan 6 weeks after their surgery. conditions: Brain Tumor conditions: Glioma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 8 type: ESTIMATED name: INBRAIN Graphene Cortical Interface measure: To evaluate the preliminary safety of the investigational device for its intended use measure: Assess the ability of the device to record signals from the brain measure: Evaluate the ability of the device to provide functional stimulation of the brain measure: Assess stability of sensing and stimulating electrodes measure: Evaluate device usability - an assessment by questionnaire of the operating surgeon's impression of the suitability of the device for sensing and stimulation during brain tumor surgery measure: Assess the quality of the recorded somatosensory evoked potentials (SEPs) - sensing part A (exploratory) measure: Assess the quality of the recorded baseline brain activity - sensing part B (exploratory) measure: Assess the ability of detecting brain evoked responses during stimulation of the brain (exploratory) measure: Evaluate decoding capability from data recorded during language task (exploratory) measure: Evaluate signal characteristics of tumour infiltrated brain regions (exploratory) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust city: Salford state: Greater Manchester zip: M6 8HD country: United Kingdom name: Hannah Howlett role: CONTACT email: [email protected] name: David J Coope, PhD FRCS role: PRINCIPAL_INVESTIGATOR lat: 53.48771 lon: -2.29042 hasResults: False |
<|newrecord|> nctId: NCT06368297 id: BSERE22-APP007-FED briefTitle: The Effect of Ketone Ester Supplementation and Ketogenic Diet on Brain Plasticity in Overweight/Obese Adults overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2024-08 date: 2024-04-16 date: 2024-04-16 name: University of Macau class: OTHER briefSummary: This project comprises an initial crossover placebo-controlled neurophysiological study to ascertain the effect of acute ketone ester ingestion on motor cortex plasticity, followed by a second 2-week intervention study aimed to compare the effect of a ketogenic diet versus ketone ester supplementation on motor cortex plasticity, resting brain function and structure, and metabolic and neuroendocrine responses. conditions: Overweight and Obesity conditions: Cognitive Change conditions: Psychophysiologic Reaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Ketone Monoester Supplementation name: Ketogenic diet measure: Brain Plasticity measure: Grey Matter Volume measure: Cortical Thickness measure: Blood-Oxygen-Level-Dependent (BOLD) Signal Changes measure: Blood Glucose measure: Blood Beta-Hydroxybutyrate measure: Blood Insulin measure: Leptin measure: Ghrelin measure: Brain-Derived Neurotrophic Factor measure: Reaction Time of Attention Network Test measure: Accuracy of Attention Network Test measure: Reaction Time of Stroop Task measure: Accuracy of Stroop Task measure: Reaction Time of N-back Task measure: Accuracy of N-back Task measure: Cerebral Hemoglobin Concentration measure: Height in Kilograms measure: Weight in Meters measure: Body Fat Percentage measure: Fat Mass measure: Muscle Mass measure: Body Water measure: Body Mass Index measure: Skinfold Thickness measure: Maximal Oxygen Uptake sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06368284 id: IRB-MTP_2022_09_202201170 briefTitle: Perineal Trauma After Jet Ski Accidents and Long-term Functional Outcomes Results acronym: TP-JET overallStatus: RECRUITING date: 2023-01-01 date: 2024-04-01 date: 2024-12-31 date: 2024-04-16 date: 2024-04-16 name: University Hospital, Montpellier class: OTHER briefSummary: French multicentric retrospective cohort study including patients who underwent an ano-perineal trauma following a personal watercraft/jet-ski accident and that were treated in France from January 2017 to December 2023. |
Aims of the study were to describe the initial management of the patients and to evaluate the digestive, urological and sexual functional outcomes as well as the quality of life, using validated questionnaires commonly employed in clinical practice. conditions: Perineum; Tear, Traumatic conditions: Anal Tear conditions: Anal Incontinence studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 20 type: ESTIMATED name: Patients who experienced an ano-perineal trauma following a PWC/Jet-Ski accident measure: Rate of fecal incontinence measure: Rate of permanent stoma measure: Rate of acontractile bladder measure: Rate of sexual dysfunction measure: Rate of impact on quality of life sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Montpellier status: RECRUITING city: Montpellier zip: 34295 country: France name: Thomas BARDOL, MD role: CONTACT phone: 04 67 33 90 69 email: [email protected] lat: 43.61092 lon: 3.87723 hasResults: False |
<|newrecord|> nctId: NCT06368271 id: Lipidomix briefTitle: Acute Effects of Dietary Medium-chain Fatty Acids on Lipid Profile acronym: Lipidomix overallStatus: COMPLETED date: 2021-10-01 date: 2024-02-28 date: 2024-02-28 date: 2024-04-16 date: 2024-04-16 name: University of Copenhagen class: OTHER briefSummary: In the present study the plasma lipid profile was elucidated in healthy, lean males by the use of lipidomic analysis in the hours after an acute intake of medium-chain fatty acids (MCT) and long chain fatty acids (LCT),, respectively. In addition oxygen uptake was measured to study energy turnover. conditions: Healthy Nutrition conditions: Diet, Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study is a randomized, double-blinded crossover design. Participants ingest Medium-chain-fatty acids (MCT) or Long-chain fatty acids (LCT) oil on two test days with one-week period between the experimental days. The day prior to the experimental days, the participants consume a eucaloric control diet, and abstain from alcohol and vigorous physical activity to ensure similar conditions on experimental days. primaryPurpose: BASIC_SCIENCE masking: NONE count: 4 type: ACTUAL name: Lipidomics measure: Meal test including medium-chain fatty acids measure: Resting metabolic rate sex: MALE minimumAge: 20 Years maximumAge: 30 Years stdAges: ADULT facility: University of Copenhagen city: Copenhagen zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 facility: Department of Nutrition, Exercise and Sports city: Copenhagen country: Denmark lat: 55.67594 lon: 12.56553 hasResults: False |
<|newrecord|> nctId: NCT06368258 id: Curr-RYR2023 briefTitle: Middle Term Effect of Red Yeast Rice on Plasma Lipids and Proteoma in Individuals With Suboptimal Cholesterolemia overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2024-12-01 date: 2025-05-02 date: 2024-04-16 date: 2024-04-16 name: University of Bologna class: OTHER briefSummary: The primary purpose of our research will be to evaluate if, in healthy subjects with a low- moderate cardiovascular risk (CV risk\>1% but \< 5%) evidenced by sub-optimal cholesterol levels as per ESC/EAS guidelines (LDL cholesterol \>115 mg/dL, \< 190 mg/dL) supplementation with a red yeast rice food supplement containing less than 3 mg total monacolins per daily dose is able to significantly influence plasma lipid levels. Furthermore, liver and muscle proteomic pattern and vascular response to dietary supplementation will be investigated. conditions: Hypercholesterolemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Red yeast rice name: Placebo measure: Treatment-dependent change in LDL-C measure: Treatment-dependent change in Total Cholesterol measure: Treatment-dependent change in Non-HDL-C measure: Treatment-dependent change in liver parameters measure: Treatment-dependent change in CPK plasma levels measure: Treatment-dependent change in plasma proteomic pattern sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AOU Policlinico S.Orsola-Malpighi city: Bologna country: Italy lat: 44.49381 lon: 11.33875 hasResults: False |
<|newrecord|> nctId: NCT06368245 id: SMART briefTitle: Durability of Suppl. Rod Constructs-SuppleMentAry Rod Technique for Long-segment Posterior Instrumented Spinal Fusions overallStatus: NOT_YET_RECRUITING date: 2024-10-15 date: 2027-12-15 date: 2029-07-31 date: 2024-04-16 date: 2024-04-16 name: AO Foundation, AO Spine class: OTHER briefSummary: This is a multicenter retrospective comparative cohort study. The index surgery for this study is primary or revision long-segment posterior thoracolumbar (TL) instrumented fusion using either a supplementary rod construct or a dual-rod construct. Eligible patients who already had index surgery, will be identified for enrollment through a review of medical records of the participating surgeons at the study sites. conditions: Spinal Fusion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1244 type: ESTIMATED name: long-segment posterior TL instrumented fusion measure: Rod fracture (RF) measure: Time to rod fracture measure: Time to rod fracture measure: Configurations of supplementary rod constructs measure: Treatment for rod fracture measure: Recurrent RFs measure: Other mechanical failures measure: Surgical complications sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Minnesota Medical Center city: Minneapolis state: Minnesota zip: 55454 country: United States name: David Polly, MD role: CONTACT email: [email protected] lat: 44.97997 lon: -93.26384 facility: University of Virginia city: Charlottesville state: Virginia zip: 22908 country: United States name: Justin S Smith, MD, PhD role: CONTACT phone: 434-243-6339 email: [email protected] name: Judith G Beenhakker role: CONTACT email: [email protected] lat: 38.02931 lon: -78.47668 hasResults: False |
<|newrecord|> nctId: NCT06368232 id: 19.036.123.125 briefTitle: Nutritional Status After Sleeve Gastrectomy in Morbid Obesity: 6-Month Study overallStatus: COMPLETED date: 2022-02-15 date: 2023-04-15 date: 2023-04-15 date: 2024-04-16 date: 2024-04-16 name: Ankara Yildirim Beyazıt University class: OTHER briefSummary: This study aims to evaluate the nutritional status of morbidly obese patients following gastric bypass surgery. Data from 76 patients aged 19-64, who will be monitored by a dietitian for at least six months, will be analyzed. Preoperative and postoperative biochemical parameters along with anthropometric measurements will assess. conditions: Bariatric Surgery Candidate conditions: Gastrostomy conditions: Obesity studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 76 type: ACTUAL name: püPatients undergoing bariatric surgery measure: Body Weight measure: BMI (Body Mass Index) measure: Lean Mass measure: Fat Mass measure: Fasting Blood Glucose measure: HbA1c measure: Iron levels measure: Vitamin D level measure: Lipid Profile (Triglycerides, LDL, HDL) sex: ALL minimumAge: 19 Years maximumAge: 64 Years stdAges: ADULT facility: Ankara Yıldırım Beyazıt University city: Ankara zip: 06760 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False |
<|newrecord|> nctId: NCT06368219 id: 0108161 briefTitle: Propofol or Benzodiazepine Combined With Ketamine for Procedural Sedation in Emergency Setting overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-10 date: 2024-04-16 date: 2024-04-16 name: Alexandria University class: OTHER briefSummary: This single blinded parallel randomized clinical trial will be conducted on 50 patients presented to Emergency Department of Alexandria Main University Hospital who are indicated for procedural sedation. All patients included in the study will be allocated randomly using computer software with concealment of randomization in to two groups: |
* Group A: 25 patients will receive ketamine (0.5 mg/kg) plus midazolam (0.05 mg/kg) |
* Group B: 25 patients will receive ketamine (0.5 mg/kg) plus propofol (0.5 mg/kg) Additional ketamine (0.25 mg/kg) will be administered in case of inadequate sedation in both groups. |
the two groups will be compared as regard incidence of complications World Society of Intravenous Anesthesia (SIVA) international sedation task force to standardize reporting adverse events conditions: Procedural Sedation studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: ketamine- midazolam versus ketamine- propofol measure: Induction and recovery time for both combinations measure: incidence and severity of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06368206 id: OBPM_Calfree2024 briefTitle: Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring (OBPM) Device at Fingertip (Aktiia G2C) Against Double Auscultation, and Comparison With Oscillometry and Aktiia Bracelet G2 overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2024-12-31 date: 2024-04-16 date: 2024-04-23 name: Aktiia SA class: INDUSTRY briefSummary: The present study, OBPM_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to evaluate the performances and safety of the Aktiia.product-G2C that doesn't require any calibrations, as compared against double auscultation for BP reference measurements, and finger pulse oximeter for pulse rate reference measurements, for a cohort of subjects characterized by a wide variety of phenotypes. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 1 study cohort that will test investigational device (Aktiia G2C) and Blood Pressure and Pulse Rate references. primaryPurpose: OTHER masking: NONE count: 85 type: ESTIMATED name: Investigational device Aktiia G2C name: Marketed device used as reference for blood pressure monitoring: double auscultation cuff name: Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2 name: Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff name: Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff name: Marketed device used as reference for pulse rate monitoring: pulse finger oximeter measure: Blood pressure mean value of differences measure: Blood pressure standard deviation of differences measure: Pulse rate root-mean-square error sex: ALL minimumAge: 21 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHUV city: Lausanne zip: 1011 country: Switzerland lat: 46.516 lon: 6.63282 hasResults: False |
<|newrecord|> nctId: NCT06368193 id: Neuralert 001 briefTitle: The Neuralert Stroke Monitor Pilot Trial overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2027-05-01 date: 2024-04-16 date: 2024-04-16 name: Neuralert Technologies LLC class: INDUSTRY briefSummary: This trial aims to demonstrate that the Neuralert Monitoring System will detect strokes before they would be identified by current standard of care. Each patient will be monitored for up to five days, depending on device connectivity or battery duration. Each monitoring session will consist of wearing a Neuralert device on each arm. For this pilot trial, we are interested in learning about Wi-Fi connectivity, successful data transmission, clinical usability, and tolerability. conditions: Stroke conditions: Surgery studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: Neuralert Monitor measure: Data Aggregation measure: Time to alarm reception measure: Time to alarm reponse measure: Stroke detection sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital of the University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Stephanie Cummings role: CONTACT phone: 215-662-3363 email: [email protected] name: Scott Kasner, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False |
<|newrecord|> nctId: NCT06368180 id: 439106274 briefTitle: The Efficacy of a RAGT & BWSTT on Children With CP overallStatus: COMPLETED date: 2020-08-30 date: 2021-02-21 date: 2021-03-08 date: 2024-04-16 date: 2024-04-16 name: King Saud University class: OTHER briefSummary: This study compared the effects of RAGT and body weight support treadmill training (BWSTT) on spatio-temporal gait parameters and walking capacity among ambulatory children with bilateral CP conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Robotic-assisted gait training Body weight-supported treadmill training primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Robotic assisted gait training measure: Gait spatio-temporal parameters measure: Six-minute walk test (6MWT) sex: ALL minimumAge: 5 Years maximumAge: 14 Years stdAges: CHILD facility: King Abdu Aziz Medical City city: Riyadh country: Saudi Arabia lat: 24.68773 lon: 46.72185 hasResults: False |
<|newrecord|> nctId: NCT06368167 id: SHR2554-202 briefTitle: A Phase II Study of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-04-16 date: 2024-04-16 name: Jiangsu HengRui Medicine Co., Ltd. class: INDUSTRY briefSummary: The study is being conducted to evaluate the efficacy and safety of SHR2554 in Patients with Relapsed or Refractory Follicular Lymphoma conditions: Follicular Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 105 type: ESTIMATED name: SHR2554 measure: Objective response rate (ORR) assessed by independent review committee (IRC) measure: ORR assessed by investigator measure: Progression free survival measure: Time to Response measure: Duration of response measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Cancer Hospital city: Beijing state: Beijing zip: 100142 country: China name: Yuqin Song role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06368154 id: HCHLL-2019-08 briefTitle: Exosome microRNAs as Potential Biomarkers of Metabolic Bone Disease of Prematurity overallStatus: RECRUITING date: 2024-01-01 date: 2026-12-31 date: 2026-12-31 date: 2024-04-16 date: 2024-04-16 name: Hunan Children's Hospital class: OTHER_GOV briefSummary: Metabolic bone disease of prematurity (MBDP) is caused by insufficient content of calcium, phosphorus, and organic protein matrix in preterm infants or bone metabolism disorder, which is one of the complications affecting the quality of life of preterm infants. The early symptoms of MBDP are insidious, and there is no unified and clear diagnostic method. The diagnosis is mostly based on typical clinical manifestations and X-ray findings, but at this time, bone mineral density has decreased significantly, so early detection and diagnosis are difficult. Studies have shown that exosomal micrornas have biological characteristics and targeting specificity, and can be used as new molecular diagnostic markers for diseases. Several studies have reported the use of plasma or serum microRNAs as molecular markers for early prediction of bone diseases. In our previous study, we extracted plasma exosomes from preterm infants for high-throughput sequencing of microRNAs, and identified differentially expressed micrornas related to bone metabolism. In this study, exosomes were used as carriers, and digital PCR was used to verify the specificity and sensitivity of plasma exosomal microRNA as biomarkers of MBDP in a large sample size. The above biomarkers were compared and verified before and after treatment in children with MBDP. Further revealing plasma exosomal microRNA as a biological indicator for evaluating the efficacy of MBDP may improve the diagnostic level of MBDP, improve the outcome and prognosis of very low birth weight preterm infants, thereby improving global health and reducing socioeconomic costs. conditions: Exosomes conditions: Newborn conditions: Bone Diseases, Metabolic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: exosomes sex: ALL minimumAge: 0 Hours maximumAge: 72 Hours stdAges: CHILD facility: Hunan Children's Hospital status: RECRUITING city: Changsha state: Hunan zip: 410007 country: China name: yinzhi y liu, master role: CONTACT phone: 13467532228 email: [email protected] lat: 28.19874 lon: 112.97087 hasResults: False |
<|newrecord|> nctId: NCT06368141 id: 2023294 briefTitle: Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer acronym: NeoCHIC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-02-28 date: 2026-04-30 date: 2024-04-16 date: 2024-04-16 name: Ruijin Hospital class: OTHER briefSummary: The goal of this clinical trial is to learn the effect of neoadjuvant chemotherapy plus sequential immune checkpoint inhibitor (ICI) therapy in locally advanced colon cancer. The main questions it aims to answer are: |
* Does this neoadjuvant chemotherapy increase the pathologic complete response (pCR) of locally advanced colon cancer? |
* Does this neoadjuvant chemotherapy improve the long-term survival of locally advanced colon cancer? |
Participants will receive: |
* a pre-operative CAPEOX (capecitabine oral + oxaliplatin i.v.)regimen. |
* a sequential CAPEOX plus Serplulimab regimen. |
* a standard complete mesocolic excision (CME) operation. conditions: Colon Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: Serplulimab name: Capecitabine name: Oxaliplatin measure: pathologic complete response sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ruijin Hospital city: Shanghai state: Shanghai zip: 200025 country: China lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06368128 id: HS-24_51 briefTitle: Climbing Lifestyle Intervention for Modifying Physical Activity Behaviors: Pilot Study acronym: CLIMB overallStatus: RECRUITING date: 2024-04-10 date: 2024-12-31 date: 2024-12-31 date: 2024-04-16 date: 2024-04-16 name: Northern Michigan University class: OTHER briefSummary: The aim of this pilot study is to determine the effects of a 12-week indoor rock climbing training program on heart health, mental health, and behavioral health in generally healthy adults aged 18-35 years old who do not exercise. Participants will learn to rock climb using ropes on an indoor rock climbing wall and participate in the training program 2-3 days per week for 60 minutes each session over 12 weeks. Health outcomes will be measured at 4 time points over the course of the study (pre-intervention, 6-weeks/mid-intervention, 12-weeks/post-intervention, and 24-weeks post-intervention). conditions: Lifestyle Factors conditions: Physical Inactivity conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial with participants allocated to either a control or intervention group; comparison between groups and within groups primaryPurpose: PREVENTION masking: NONE count: 12 type: ESTIMATED name: Indoor Rock Climbing Exercise Training Program measure: Fasting lipids measure: Fasting glucose measure: Hemoglobin a1c measure: Physical activity and sedentary behavior measure: Sedentary behavior bouts (30 min, 60 min, >60 min) measure: Cardiorespiratory fitness measure: Muscular fitness measure: Handgrip strength asymmetry measure: Lower-body dynamic balance measure: Health-related quality of life using CDC Health-Related Quality of Life Scale measure: Exercise self-efficacy measured via Self-efficacy for exercise scale measure: Perceptions of exercise measured via Views and Attitudes Toward Exercise Scale measure: Perceived stress measure: Blood pressure measure: Body composition measure: Bone density sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Northern Michigan University status: RECRUITING city: Marquette state: Michigan zip: 49855 country: United States name: Lisa Eckert, PhD role: CONTACT phone: 906-227-1291 email: [email protected] name: Megan C Nelson, PhD role: PRINCIPAL_INVESTIGATOR lat: 46.54354 lon: -87.39542 hasResults: False |
<|newrecord|> nctId: NCT06368115 id: 00023453 id: 4R33AG069794 type: NIH link: https://reporter.nih.gov/quickSearch/4R33AG069794 briefTitle: A Program to Reduce Inappropriate Medications Among Older Adults With Alzheimer's Disease: Implementation Phase 2 acronym: DPRESCRIBE-AD2 overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-06 date: 2024-04-16 date: 2024-04-16 name: University of Massachusetts, Worcester class: OTHER name: National Institute on Aging (NIA) name: Harvard Pilgrim Health Care name: Humana Healthcare Research, Inc. name: Carelon Research briefSummary: Potentially inappropriate prescribing includes the use of medications that may no longer be necessary or that may increase the risk of harm. Inappropriate prescribing can increase the overall symptom burden, and negatively affect health-related quality of life and function. The inappropriate prescription of certain drug categories such as sedative/hypnotics, antipsychotics, and strong anticholinergic agents poses particular risks for older adults, and may be more common among those with Alzheimer's disease and Alzheimer's disease- related dementias (AD/ADRD) due to a higher prevalence of multimorbidity and more frequent prescription of five or more medications. The D-PRESCRIBE-AD (Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease) study will test a health plan-based intervention using the NIH Collaboratory's Distributed Research Network, which employs the Food and Drug Administration (FDA) Sentinel System infrastructure. The overarching goal of this randomized controlled trial is to assess the effect of a patient/caregiver- centered, multifaceted educational intervention on potentially inappropriate prescribing in patients with AD/ADRD. The research hypothesis is that education on inappropriate prescribing among patients/caregivers and their providers can reduce medication-related morbidity in patients with AD/ADRD and improve medication safety for this vulnerable population. The study population will include community-dwelling patients with AD/ADRD, identified based on diagnoses codes of AD/ADRD or use of a medication for Alzheimer's Disease, who have evidence of potentially inappropriate prescribing the three drug classes above. The trial will evaluate the effect of mailed educational interventions, including the effect of a second reminder mailing, designed to spur patient/caregiver-provider communication about medication safety (versus usual care) on the proportion of patients with inappropriate prescribing, the primary outcome of this study. The trial will be conducted in two large, national health plans. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study design will be a prospective, randomized, "open-label" educational intervention trial with three arms: (1) a combined patient/caregiver and provider educational intervention mailed one time; (2) a combined patient/caregiver and provider educational intervention mailed two times; and (3) usual care. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 10000 type: ESTIMATED name: Educational Materials measure: Absence of Inappropriate Medication Prescription Dispensing measure: Dose Change measure: Polypharmacy measure: Rates of Health Care and Emergency Care Utilization measure: Mortality measure: Switching within Classes sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UMass Chan Medical School city: Worcester state: Massachusetts zip: 01605 country: United States name: Cassie L Saphirak role: CONTACT phone: 508-856-3493 email: [email protected] lat: 42.26259 lon: -71.80229 hasResults: False |
<|newrecord|> nctId: NCT06368102 id: R6-03 briefTitle: Prophylactic Effects for Preventing Surgical Site Infection in Third Molar Surgery overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04 date: 2025-08 date: 2024-04-16 date: 2024-04-16 name: Uji Takeda Hospital class: OTHER briefSummary: The purpose of this study is to determine the incidence of surgical site infection (SSIs) after third molar surgery for different duration of intravenous ampicillin administration. conditions: Surgical Site Infection studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 70 type: ESTIMATED name: Ampicillin measure: Occurrence of surgical site infection measure: Occurrence of alveolar osteitis sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06368089 id: REC.66-474-30-2 id: MR-PSU:66-30-21-406 type: OTHER_GRANT domain: Faculty of Medicine, Prince of Songkla University briefTitle: Short Effects of SIMT and EM in Prolonged Mechanically Ventilated Patients overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-02 date: 2026-03 date: 2024-04-16 date: 2024-04-16 name: Prince of Songkla University class: OTHER briefSummary: Using mechanical ventilation for more than 18 hours can affect respiratory muscle and postural muscle control, making it difficult to wean off the ventilator and reducing mobility. The aim of this study is to: |
1. Compare the effects of respiratory muscle strength training and early mobilization on dynamic lung compliance and maximum inspiratory pressure before and after a 7-day training period. |
2. Compare the success rate of weaning and the duration of weaning between the respiratory muscle strength training and the early mobilization program. conditions: Ventilator Dependent studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomization primaryPurpose: TREATMENT masking: NONE count: 46 type: ESTIMATED name: Inspiratory muscle training (IMT) group name: Early mobilization (EM) group measure: Maximum inspiratory pressure (MIP) measure: Dynamic lung compliance (Cdyn) measure: Weaning time measure: Weaning outcome measure: Grip strength measure: chest wall expansion sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Respiratory Care Unit (MRCU), Prince of Songklanakarind Hospital city: Songkhla zip: 90110 country: Thailand lat: 7.19882 lon: 100.5951 hasResults: False |
<|newrecord|> nctId: NCT06368076 id: H-23065096 briefTitle: High-intensity Interval Training in Patients With Spinal Muscular Atrophy overallStatus: RECRUITING date: 2024-01-09 date: 2024-08 date: 2025-01 date: 2024-04-16 date: 2024-04-16 name: Rigshospitalet, Denmark class: OTHER briefSummary: Patients with spinal muscular atrophy who are wheelchair users often experience lower back - and gluteal pain, reduced sleep quality, constipation and reduced quality of life - symptoms that regular exercise could potentially alleviate. However, only very little research has been done on exercise for patients who are wheelchair users. The aim of this study is to explore the impact of cycle exercise on patients with spinal muscular atrophy. conditions: Spinal Muscular Atrophy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Exercise measure: Questionnaire on fatigue measure: Questionnaire on pain. measure: Questionnaire on constipation measure: Questionnaire on quality of life measure: Questionnaire on sleep quality measure: Blood sample measure: Blood sample measure: Blood sample measure: Blood sample measure: Blood sample measure: Blood sample measure: Blood sample measure: Blood sample measure: Blood sample measure: Blood sample measure: MRI scan liver size measure: MR-elastography measure: MRI scan liver steatosis measure: Ultrasound scan measure: MRI scan measure: MRI scan measure: Exercise test measure: Motorscore sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet status: RECRUITING city: Copenhagen zip: 2100 country: Denmark name: Sophia Frølich, stud.med role: CONTACT phone: + 45 3545 3561 email: [email protected] name: Noémie Receveur, stud.med role: CONTACT phone: +4535453561 email: [email protected] lat: 55.67594 lon: 12.56553 hasResults: False |
<|newrecord|> nctId: NCT06368063 id: HE-202301 briefTitle: The Study of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2028-03 date: 2024-04-16 date: 2024-04-25 name: Health Science Center of Xi'an Jiaotong University class: OTHER name: LinkDoc Technology (Beijing) Co. Ltd. name: Huazhong University of Science and Technology briefSummary: The study is a multicenter, prospective clinical study aimed at evaluating the efficacy and safety of Huaier Granule in postoperative adjuvant treatment of resectable pancreatic cancer conditions: Pancreatic Cancer Resectable studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 642 type: ESTIMATED name: Huaier granule name: chemotherapy drugs measure: Disease-free survival measure: Overall survival measure: Progression-free survival measure: The incidence and severity of adverse events (AE) and severe adverse events (SAE) measure: The incidence and severity of ADR, severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06368050 id: IRB00067187.2 briefTitle: Implementation of an Evidence-Based Intervention to Improve Head Impact Safety in Youth Football overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-11 date: 2024-11 date: 2024-04-16 date: 2024-04-16 name: Wake Forest University Health Sciences class: OTHER name: Childress Institute briefSummary: The objective of this study is to evaluate the feasibility of implementing an evidence-based intervention program, COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) on a larger scale. Coaches of 12U (12 years old and under), and 13U (13 years old and under) teams within six youth football organizations will pilot test the intervention. Aim 1 will conduct focus groups with coaches, parents, and organizational leaders to assess organizational needs, capacity, and readiness to adopt the intervention program. Aim 2 will evaluate the effectiveness of the intervention program at reducing HIE and injuries and evaluate implementation success. Aim 2 results (intervention outcomes) are reported herein. conditions: Head Injury conditions: Sport Injury studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: practice structure intervention measure: Number of practice head impacts measure: Number of practice head acceleration events measure: Practice head impact rate measure: Practice head acceleration even rate measure: Median linear acceleration measure: Median rotational acceleration measure: Median rotational velocity measure: 95th percentile linear acceleration measure: 95th percentile rotational acceleration measure: 95th percentile rotational velocity measure: Feasibility of Intervention Measure (FIM) Values measure: Acceptability of Intervention Measure (AIM) Values measure: Number of practices the intervention was implemented as prescribed measure: Average minutes per practice of live time sex: ALL minimumAge: 11 Years maximumAge: 14 Years stdAges: CHILD facility: Wake Forest University Health Sciences city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Jill Urban, PhD, MPH role: CONTACT phone: 336-716-0947 email: [email protected] name: Konstantia Strates role: CONTACT phone: 336-713-1263 email: [email protected] name: Jill Urban, PhD, MPH role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 hasResults: False |
<|newrecord|> nctId: NCT06368037 id: DragonFire-02 briefTitle: Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-06 date: 2026-06 date: 2024-04-16 date: 2024-04-16 name: Hangzhou Valgen Medtech Co., Ltd class: INDUSTRY briefSummary: This study is a prospective, single-center, single-group design exploratory clinical research. No control group is set, and only subjects meeting the indications of the study device are treated. After patients sign informed consent, they are screened, and those meeting the inclusion criteria are enrolled. The treatment involves using myocardial radiofrequency ablation system and catheter-based myocardial radiofrequency ablation needle and its guidance system for treating obstructive hypertrophic cardiomyopathy. All subjects are followed up before discharge, and at 30 days, 3 months, 6 months, and 12 months postoperatively. conditions: Obstructive Hypertrophic Cardiomyopathy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: DragonFire Transcatheter Myocardial Radiofrequency Ablation System measure: The rate of freedom from major adverse events at 30 days postoperatively measure: The success rate of treatment at 6 months postoperatively sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northern Theater Command General Hospital of the Chinese People's Liberation Army city: Shenyang country: China lat: 41.79222 lon: 123.43278 hasResults: False |
<|newrecord|> nctId: NCT06368024 id: CL-12-600 briefTitle: Establishment of Delphi-MD Safety Performance and Reliability overallStatus: COMPLETED date: 2023-11-28 date: 2023-11-28 date: 2023-11-28 date: 2024-04-16 date: 2024-04-26 name: QuantalX Neuroscience class: INDUSTRY briefSummary: A retrospective analysis of collected datasets. In this study we aim to establish Delphi-MD's safety and performance reliability for assessment and monitoring of Transcranial Magnetic Stimulation (TMS) Evoked Potentials (TEPs) as neurophysiological measurements. conditions: Neurologic Disorder conditions: Healthy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 263 type: ACTUAL name: This is a retrospective analysis study of data collected with a diagnostic medical device measure: Cortical Excitability measure: Specific Peak Amplitudes measure: GMFP sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: QuantalX Neuroscience Ltd. city: Kfar Saba state: Center zip: 4453001 country: Israel lat: 32.175 lon: 34.90694 hasResults: False |
<|newrecord|> nctId: NCT06368011 id: MustafaKU-CINCINOGLU-001 briefTitle: The Impact of Acceptance and Commitment Therapy on Stigmatization overallStatus: ENROLLING_BY_INVITATION date: 2023-04-15 date: 2023-07-31 date: 2024-06-30 date: 2024-04-16 date: 2024-04-16 name: Mustafa Kemal University class: OTHER briefSummary: The goal of study is to determine the effect of acceptance and commitment therapy-based psychoeducation on the level of stigmatization applied to relatives of schizophrenia patients. |
Type of study: This study was planned as a pretest-posttest quasi-experimental design with an observation and control group. |
Participants: The population of the study consisted of the relatives of schizophrenia patients who were registered and actively attending the Community Mental Health Center in a state hospital in Ankara. |
Intervention: Before the psychoeducation process started, personal information form and scales were applied to the relatives of the patients in the experimental and control groups. An ACT-based psychoeducation program consisting of 8 sessions was applied to the experimental group. each session lasted approximately 90 minutes. The control group did not receive any intervention. After the psychoeducation, the scales were reapplied to the experimental and control groups. In addition, the experimental group was asked to fill out the psychoeducation evaluation form. The scales were reapplied to the experimental group after the 1-month follow-up study and evaluated. conditions: Stigmatization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: acceptance and commitment therapy measure: Stigma Scale for Relatives of Patients with Schizophrenia measure: Stigma Scale for Relatives of Patients with Schizophrenia measure: Stigma Scale for Relatives of Patients with Schizophrenia measure: Stigmatization Scale measure: Stigmatization Scale measure: Stigmatization Scale sex: ALL minimumAge: 18 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hatay Mustafa Kemal Üniversitesi city: Hatay country: Turkey lat: 38.40227 lon: 27.10486 hasResults: False |
<|newrecord|> nctId: NCT06367998 id: PC24MISV0017 briefTitle: The Effect of Pregabalin on Shoulder Pain of Patients With Central Sensitization Who Undergo Arthroscopic Rotator Cuff Repair overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2026-05-01 date: 2024-04-16 date: 2024-04-16 name: The Catholic University of Korea class: OTHER name: Viatris Korea briefSummary: This study aims to investigate the effects of Pregabalin intake on shoulder pain management in patients with central sensitization undergoing arthroscopic rotator cuff repair. Although Pregabalin is known to be effective in controlling pain after shoulder arthroscopy, research on its efficacy in pain management for patients with central sensitization is scarce. Utilizing a list that identifies central sensitization, this study will explore whether Pregabalin can reduce postoperative pain in these patients and potentially improve joint mobility, emotional, and physical functioning. A prospective randomized study is planned, with inclusion criteria set for patients aged between 19 and 70 who have undergone arthroscopic rotator cuff repair. |
The study will compare clinical outcomes up to one year postoperatively between two groups of 38 patients each. The case group will receive standard postoperative medications (NSAIDs) plus Pregabalin oral intake from the day before surgery to six weeks postoperatively, while the control group will receive only the standard postoperative medications without Pregabalin. conditions: Rotator Cuff Tears conditions: Central Sensitisation conditions: Neuropathic Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 76 type: ESTIMATED name: Pregabalin measure: VAS pain score measure: Constant shoulder score measure: American shouler and elbow surgeons (ASES) score sex: ALL minimumAge: 20 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06367985 id: 03/24/DD-BVMD briefTitle: CAPA-IVM Culture With Low Oxygen Tension overallStatus: NOT_YET_RECRUITING date: 2024-05-03 date: 2024-06-01 date: 2025-06-01 date: 2024-04-16 date: 2024-04-29 name: Mỹ Đức Hospital class: OTHER name: Vrije Universiteit Brussel briefSummary: Capacitation in-vitro maturation (CAPA-IVM) has recently been advanced in culturing oocytes from the germinal vesicle (GV) stage following mild or no controlled ovarian stimulation. Recent research suggested that O2 concentration may significantly regulate oocyte maturation and early embryo development through hypoxia-inducible factor (HIF). Nonetheless, it has been challenging to create the environmental culture conditions for addressing the optimal number of oocytes and the highest possibility of embryo development since consensus on the oxygen (O2) concentration index in the IVM culture environment has not been reached. Based on the outcomes of atmospheric O2 concentration (20%) and low O2 concentration (5%) during CAPA-IVM culture in mice, it has been hypothesized that a 5% O2 was the optimal culture condition for the pre-IVM step. A 20% O2 was more suitable for the IVM culture step. Therefore, this study is designed to enhance the CAPA-IVM culture system, improving treatment efficiency and providing various benefits for patients undergoing assisted reproductive technology. conditions: In Vitro Fertilization studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Sibling oocytes primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Air Oxygen Concentration CAPA-IVM culture name: Low Oxygen Concentration CAPA-IVM culture measure: Maturation rate measure: Total number of oocytes retrieval measure: Number of patients with no oocyte retrieved measure: Number of MII oocytes measure: Number of GV oocytes measure: Number of patients with no matured oocyte measure: Number of 2PN oocytes measure: Fertilization rate measure: Abnormal fertilization rate measure: Number of patients with no day-3 embryo measure: Number of day-3 embryos measure: Number of good quality Day-3 embryos measure: Number of frozen day-3 embryos measure: Number of blastocyst (day 5 or day 6 embryo) measure: Number of patients with no blastocyst measure: Number of good quality blastocysts measure: Number of frozen blastocysts measure: Number of embryos transferred measure: Quality of embryos transferred (Grade 1, Grade 2, Grade 3) measure: Positive pregnancy test rate measure: Implantation rate measure: Clinical pregnancy rate measure: Ectopic pregnancy rate measure: Ongoing pregnancy rate measure: Miscarriage <12 weeks rate (Early miscarriage) measure: Miscarriage <22 weeks rate (late miscarriage) measure: Live birth rate measure: Multiple pregnancy rate measure: Multiple delivery rate measure: Mode of delivery measure: Gestational age at birth measure: Birth weight measure: Very low birth weight rate measure: Low birth weight rate measure: High birth weight rate measure: Very high birth weight rate measure: Small for gestational age rate measure: Large for gestational age rate measure: Hypertension in pregnancy rate measure: Gestational diabetes mellitus rate measure: Still birth rate measure: Premature birth rate measure: Antepartum haemorrhage rate measure: Major congenital abnormalities rate measure: Neonatal mortality rate measure: NICU admission rate measure: Reason for NICU admission sex: FEMALE minimumAge: 18 Years maximumAge: 42 Years stdAges: ADULT facility: My Duc Hospital city: Ho Chi Minh City country: Vietnam name: Tuong M Ho, MSc, MD role: CONTACT phone: +84 90 3633377 email: [email protected] lat: 10.82302 lon: 106.62965 hasResults: False |
<|newrecord|> nctId: NCT06367972 id: 2024-0070 id: NCI-2024-03278 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: A Randomized Phase II Basket Trial EXTENDing Efficacy of Systemic Therapy With Local Consolidative Therapy for OligoProgressive Metastatic Disease (EXTEND-OP) overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2028-10-10 date: 2030-10-10 date: 2024-04-16 date: 2024-04-16 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To find out if local consolidation therapy (such as radiation therapy with or without other local therapies such as surgery, ablation \[the removal or destruction of a body part or tissue or its function\], or embolization \[a procedure that uses particles, such as tiny gelatin sponges or beads, to block a blood vessel\]) to all progressive sites of disease can help to control the disease compared with next-line systemic therapy. conditions: OligoProgressive Metastatic Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Local Consolidation Therapy name: Next-line Systemic Therapy measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Ethan Ludmir, MD role: CONTACT phone: 832-729-0998 email: [email protected] name: Ethan Ludmir, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False |
<|newrecord|> nctId: NCT06367959 id: 2021-0324 id: NCI-2024-02939 type: OTHER domain: NCI-CTRP Clinical Trials Registry briefTitle: Health Benefits of Writing Therapy Among Asian American Cancer Survivors overallStatus: RECRUITING date: 2023-07-27 date: 2026-08-31 date: 2026-08-31 date: 2024-04-16 date: 2024-04-17 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To learn more about participant experience as a Asian American immigrant breast cancer survivor and how writing about participant experiences may affect participant's health. conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 192 type: ESTIMATED name: Esays name: Questionnaires measure: Primary Outcome Measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Qian Lu, MD, PHD role: CONTACT phone: 713-745-8324 email: [email protected] name: Qian Lu, MD, PHD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False |
<|newrecord|> nctId: NCT06367946 id: XH-24-0093 briefTitle: Mechanism Study of Ventilator-Induced Lung Injury in Elderly People. overallStatus: RECRUITING date: 2023-06-01 date: 2024-07-01 date: 2027-06-30 date: 2024-04-16 date: 2024-04-16 name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine class: OTHER briefSummary: 1. We collect lung tissues from patients with different ages and confirm that KLK8 expression is positively correlated with age. |
2. We collect peripheral blood from patients with different ages and duration of mechanical ventilation to explore the correlation between the degree of endothelial/epithelial damage, age and duration of mechanical ventilation. conditions: Ventilator-Induced Lung Injury studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: mechanical ventilation measure: KLK8 concentration of lung tissue measure: Endothelial/epithelial damage index concentration in peripheral blood sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Xinhua hospital status: RECRUITING city: Shanghai zip: 200000 country: China name: Lai Jiang, PhD role: CONTACT phone: 13817719616__ email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06367933 id: MISNM briefTitle: Mini-invasive Spine Surgery for Neuromuscolar Scoliosis acronym: MISNM overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-05 date: 2024-04-16 date: 2024-04-25 name: Istituto Ortopedico Rizzoli class: OTHER briefSummary: Neuromuscular scoliosis (SNM) are deformities related to the impairment of normal function of the central nervous system (CNS) and/or peripheral nervous system (PNS) resulting in alterations to the of the functional unit represented by the integrated motor sequence (SIM). At the level of the spine, dysfunction of the SIM results in altered dynamic support of the spine. This results in a control of the trunk that is not harmonious due to the lack of effective mechanisms of muscle compensation. In particular, a greater degree of pelvic tilt with respect to the ground plane, with an increase in the degree of the so-called pelvic obliquity (OP), a fundamental parameter in walking and maintaining the seated posture. Spinal deformity causes severe alterations of the rib cage resulting in respiratory failure that often requires ventilatory supports and is associated with frequent airway infections, including pneumonias, often fatal. SNMs also express other comorbidities: cardiac (heart failure), neurological (epilepsy), nutritional that necessitate careful management multidisciplinary and especially anesthesiological evaluation for the peri-operative management. The surgical treatment of SNM constitutes a topic that is still debated due to both the bio-mechanical peculiarities of SNM and the clinical features, particularly comorbidities, that characterize this patient population. Compared with idiopathic scoliosis surgery, in SNM there is a higher rate of complications. To date, most of the complications are respiratory in nature (23%), followed by complications mechanical of the implanted surgical instrumentation (13%), and surgical site infections (11%). Furthermore, there is evidence that SNM surgery correlates with increased blood loss intraoperative. To date, it is recognized in the literature that the safest and most effective surgical treatment for SNMs is arthrodesis posterior instrumented with pedicle screws extended to the pelvis. In the years, mini-invasive surgical techniques have become increasingly prominent. invasive with the goal of reducing operative time, blood loss and complications themselves. conditions: Neuromuscular Scoliosis conditions: Spine Deformity conditions: Surgery conditions: Vertebral Fusion studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: mini-invasive spine surgery measure: Visual Analogue Scale measure: Visual Analogue Scale measure: Spine Correction measure: Spine Correction sex: ALL minimumAge: 9 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Istituto Ortopedico Rizzoli city: Bologna zip: 40136 country: Italy lat: 44.49381 lon: 11.33875 hasResults: False |
<|newrecord|> nctId: NCT06367920 id: 2022-02-005 briefTitle: Multicenter Study on Rehabilitation Medical Data for Pediatric Big Brain Development overallStatus: RECRUITING date: 2023-03-23 date: 2024-12-31 date: 2024-12-31 date: 2024-04-16 date: 2024-04-16 name: Bundang CHA Hospital class: OTHER briefSummary: Retrospective study for development of imaging-genetics (brain imaging/genome big data) models and algorithms that are clinically explainable and have high predictive performance in brain research on pediatric developmental disorders conditions: Pediatric ALL conditions: Healthy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2000 type: ESTIMATED name: Magnetic Resonance Imaging, Behavioral assessments measure: Brain magnetic resonance imaging measure: Medical records sex: ALL maximumAge: 20 Years stdAges: CHILD stdAges: ADULT facility: CHA Bundang Medical Center, CHA University status: RECRUITING city: Seongnam-si state: Gyeonggi-do zip: 463-712 country: Korea, Republic of name: Minyoung Kim, M.D., Ph.D. role: CONTACT phone: 82-31-780-1872 email: [email protected] lat: 37.43861 lon: 127.13778 hasResults: False |
<|newrecord|> nctId: NCT06367907 id: SM 68/6-1 briefTitle: Biological Effects of Schema Therapy acronym: BE-ST overallStatus: RECRUITING date: 2021-09-09 date: 2024-12 date: 2025-06 date: 2024-04-16 date: 2024-04-16 name: Jena University Hospital class: OTHER briefSummary: Background: The major aim of this study is to compare the effects of emotion focused (experiential) and cognitive interventions of schema therapy (ST) on emotion regulation deficits in patients with borderline personality disorder (BPD) according to DSM-V (alternative model) criteria. In a randomized, single-blinded parallel-group design clinical effects as well as effects on neurotransmitter metabolism and connectivity will be compared. |
Method: While the 9-weeks treatment protocol of particular interest includes emotion focused interventions (ST-EF, n=60) such as chair dialogs, imagery rescripting or role play, the active control condition (ST-AC, n=60) is restricted to cognitive interventions, e.g. psychoeducation or pro/contra discussions. MEGA-PRESS 1H-MR spectroscopy and resting-state functional MR imaging (rs-fMRI) will be used before/after treatment protocols (T0-T1) and 6 months after the end of therapy (T2) to assess the effects on glutamate (Glx) and GABA metabolism in key regions of the target networks (executive control network, ECN: dorsolateral prefrontal cortex, DLPFC; salience network, SN: anteromedial cingulate cortex, aMCC; default mode network, DMN: pregenual cingulate cortex, pgACC) and to investigate the corresponding altered connectivity in these networks. The biological aberrations at T0 as compared to healthy controls (n=60) and treatment effects (at T1 and T2, n≥40 in each condition) on these aberrations will be linked to clinical effects measured by an extensive test battery with particular interest on emotion regulation, and specified by the Reliable Change Index (RCI). For longitudinal data mixed model analysis will be performed. |
The main questions are (1) whether the emotion regulation deficit and the pattern of BPD-specific symptomatology are associated with a specific pattern of Glx and GABA concentrations in the DLPFC, aMCC and pgACC and corresponding deviations of functional connectivity within the ECN, SN and DMN. Hypothesis: Depending on primary and secondary outcome measures at T0, altered RSFC in the DMN, SN and ECN and corresponding altered Glx or GABA concentrations are assumed. (2) whether both treatment conditions have different clinical effects on the ability to regulate emotions and whether the respective clinical effects are associated with the changes in neurobiological aberrations. Hypothesis: It is hypothesized that the ST-EF condition will improve emotion regulation skills more effectively than the control condition. Only in the ST-EF condition are higher response and remission rates expected in the primary and secondary outcome measures, as well as effects on the ECN, SN and DMN with corresponding changes in RSFC and Glx or GABA concentrations. conditions: Personality Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized, parallel-group, single-blinded primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Parallel-group: Both conditions (emotion focussed, ST-EF and active control, ST-AC) are highly standardized and active in terms of their expected clinical effect, which was a precondition for a positive ethics approval. |
Randomized: Patients are randomly assigned to the ST-EF or ST-AC condition according to a randomization list established by an independent statistician, and applied to incoming help-seeking patients by an independent admission management (managing nurse, not a member of the research team). |
Single-blinded: Researchers are blind as regards group belonging of participants. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: schema therapy measure: Changes in emotion regulation capabilities measure: Improvement of BPD specific symptomatology measure: Change of personality traits measure: Changes of the intensity of early maladaptive schemas. measure: Changes of the intensity of schema modes. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Jena status: RECRUITING city: Jena zip: 07743 country: Germany name: Stefan Smesny, PhD role: CONTACT phone: +4936419390451 email: [email protected] lat: 50.92878 lon: 11.5899 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol: Study Protocol: Study design date: 2018-06-04 uploadDate: 2024-04-12T04:07 filename: Prot_000.pdf size: 653719 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol: Study Protocol: Study design date: 2018-06-04 uploadDate: 2024-04-12T04:14 filename: Prot_001.pdf size: 454285 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol: Information on reliability criteria of assessment tools date: 2018-06-04 uploadDate: 2024-04-12T04:22 filename: Prot_002.pdf size: 605787 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol: Core aspects of therapy conditions date: 2018-06-04 uploadDate: 2024-04-12T04:23 filename: Prot_003.pdf size: 440449 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2018-06-04 uploadDate: 2024-04-12T04:10 filename: SAP_004.pdf size: 692600 hasResults: False |
<|newrecord|> nctId: NCT06367894 id: STONECARE briefTitle: Treatment Optimization and Nephrolithiasis Recurrence Prevention With Interdisciplinary Care overallStatus: RECRUITING date: 2023-12-12 date: 2024-12-31 date: 2024-12-31 date: 2024-04-16 date: 2024-04-16 name: Agnieszka Pozdzik class: OTHER briefSummary: Nearly 10% of the Belgian population suffer from kidney stone disease. Recent reviews reported that kidney stones represent an underestimated risk factor for further kidney function deterioration. Preventive measures are recommended in lithiases patients to prevent the formation of new stones. The individual effects of different medicated prosthetic interventions have been documented in clinical trials. However, there is little data on the effectiveness of combining these different preventive measures in routine clinical practice (real-world context). |
Patients with kidney stone disease require a complete metabolic assessment. The three main factors contributing to the stone's formation are the patient's metabolism, diet and lifestyle. Metabolic work-up is recommended by the American Urology Association to identify and correct the factors responsible for urinary stone formation such as hypercalciuria, hyperoxaluria, hyperuricuria, hypocitraturia or abnormalities of urinary pH. The metabolic work-up includes at minimum the 24h urine test, a blood test and spot urine test. Dietary habits and lifestyle are assessed by means of a questionnaire. |
The CHU Brugmann Hospital has a specialized multidisciplinary clinic for renal lithiases and mineral metabolism. Preventive personalized and interdisciplinary care in CHU Brugmann consists of a full metabolic work-up allowing the identification of lithogenic risk factors by nephrologists, dietary assessment by specialized dieticians and specific treatment protocol associated with regular follow-up. |
The aim of this study is to evaluate, in the context of a retrospective single-center cohort study, the effect of preventive personalized and interdisciplinary care on the evolution of all urinary lithogenic risk factors and the recurrence of kidney stones (rate of renal colics, emergency room admissions, and urological interventions). conditions: Kidney Stone studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 164 type: ESTIMATED measure: Number of acute renal colics measure: Number of emergency admissions measure: Number of surgeries measure: Number of hospitalizations measure: Identified genetics abnormalities measure: Wisconsin questionnaire measure: Kidney function outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Brugmann status: RECRUITING city: Brussels zip: 1020 country: Belgium name: Agnieszka POZDZIK role: CONTACT phone: 024772641 email: [email protected] name: Sirika Chhem role: PRINCIPAL_INVESTIGATOR lat: 50.85045 lon: 4.34878 hasResults: False |
<|newrecord|> nctId: NCT06367881 id: MD 185/ 2022 briefTitle: Assessment Of Dose-Dependent Immunomodulatory Effect Of Alveofact With or Without Steroisd In Neonatal RDS overallStatus: RECRUITING date: 2022-08-18 date: 2024-07 date: 2024-10 date: 2024-04-16 date: 2024-04-16 name: Ain Shams University class: OTHER briefSummary: An Exploratory Randomized double-arm controlled trial to evaluate the immunomodulatory effect of low versus high dose of Alveofact with or without Budesonide. conditions: Neonatal Respiratory Distress Syndrome conditions: Inflammatory Response conditions: Premature Lungs conditions: Neutrophil Extracellular Trap Formation conditions: Preterm Birth studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Alveofact name: Budesonide measure: Assessment of Neutrophil Extracellular Trap (NET) measure: comparison of Alveolar with whole blood NET formation measure: Clinical out come measure: Assessment of Reactive Oxygen Species (ROS) measure: oxygen needs measure: Hospital stay sex: ALL minimumAge: 1 Day maximumAge: 2 Days stdAges: CHILD facility: Egypt Neonatal Intensive Care Units (NICUs), Ain Shams University Cairo, Abbasia, Egypt, 11517 status: RECRUITING city: Cairo country: Egypt name: Ain Shams University role: CONTACT lat: 30.06263 lon: 31.24967 hasResults: False |
<|newrecord|> nctId: NCT06367868 id: E-83045809-604.01.02-179951 briefTitle: Optic Nerve Sheath Diameter: A Non-Invasive Indicator of Intracranial Pressure in the Intensive Care Unit Monitoring overallStatus: COMPLETED date: 2021-09-09 date: 2022-06-01 date: 2022-12-01 date: 2024-04-16 date: 2024-04-16 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: Determination of high intracranial pressure (ICP) is necessary for the treatment of patients with raised ICP to improve long-term neurological outcomes. Ultrasonographic optic nerve sheath diameter (ONSD) measurement is a noninvasive, easily performed and cost effective technique for detecting high ICP. conditions: ICP (Intracranial Pressure) Increase conditions: Optic Nerve Sheath Diameter conditions: Intracranial Hypertension studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 44 type: ACTUAL name: After 5 ml CSF Drainage measure: Intracranial Pressure-1 (ICP-1) measure: Optic Nerve Sheath Diameter-1 (ONSD-1) measure: Intracranial Pressure-2 (ICP-2) measure: Optic Nerve Sheath Diameter-2 (ONSD-2) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul University-Cerrahpasa city: Istanbul state: Fatıh zip: 34098 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06367855 id: KSKC20222025 briefTitle: Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF : Double Blinded, Randomized Control Trial acronym: MIS-TLIF overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2025-05-31 date: 2024-04-16 date: 2024-04-16 name: Potsawat Surabotsopon class: OTHER briefSummary: Researchers are considering Dexamethasone as preemptive medication before minimally invasive spine fusion surgery to minimize postoperative back pain with minimal side effects, aiming to enhance the effectiveness of surgery and improve patient outcomes. conditions: Spinal Stenosis Lumbar conditions: Disc Degeneration conditions: Disc Disease conditions: Fusion of Spine conditions: Surgery studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Dexamethasone name: Normal saline measure: effectiveness of dexamethasone measure: Morphine consumption measure: Complication measure: Fusion rate measure: Length of hospital stay sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06367842 id: MED-02-2023 briefTitle: Orthopaedic Specimen Pathology and Early Diagnosis of ATTR Cardiopathy (ATTR-ORTHO) acronym: ATTR-ORTHO overallStatus: RECRUITING date: 2024-02-27 date: 2025-04 date: 2025-09 date: 2024-04-16 date: 2024-04-16 name: Institut Mutualiste Montsouris class: OTHER briefSummary: The goal of this observational study is to learn about the frequency of ATTR amyloid, cardiac involvement and associated features, in 150 patients aged 50 or more years, and operated for an idiopathic carpal tunnel syndrome, lumbar spine stenosis or total hip or knee arthroplasty for primary osteoarthritis. The main questions to be answered are: |
1. What is the frequency of ATTR deposits in samples retrieved during surgery? |
2. What is the frequency of cardiac involvement in ATTR positive patients? |
3. What are the preoperative predictors of ATTR deposits? Participants will |
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