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Despite the current recommendations from the French Society of Anesthesiology and Intensive Care (SFAR) and the French Society of Pharmacology and Therapeutics (SFPT), there are no recommendations on prescription modalities for patients under veno-arterial extracorporeal membrane oxygenation (VA-ECMO). The use of antibiotic therapy is common in VA-ECMO patients and their pharmacokinetic variability factors are then exacerbated.
We aim to conduct a prospective, multicenter, interventional study designed to identify predictive factors for failure to achieve therapeutic target circulating concentrations of beta-lactams in patients under VA-ECMO treated with one of the studied beta-lactams conditions: Cardiogenic Shock conditions: Post-cardiac Surgery conditions: Cardiac Arrest conditions: Extracorporeal Membrane Oxygenation Complication conditions: Infections studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 225 type: ESTIMATED name: Therapeutic drug monitoring of beta-lactam measure: Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem. measure: Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem. measure: Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem. measure: Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem. measure: Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Clermont Ferrand - Hôpital Gabriel Montpied city: Clermont-Ferrand zip: 63003 country: France lat: 45.77966 lon: 3.08628 facility: CHU Dijon-Bourgogne city: Dijon zip: 21000 country: France name: Pierre-Alain BAHR, MD role: CONTACT lat: 47.31667 lon: 5.01667 facility: Aphp Pitie Salpetriere city: Paris zip: 75013 country: France name: PAULINE DUREAU, MD role: CONTACT lat: 48.85341 lon: 2.3488 facility: CHU ROUEN - Hôpital Charles-Nicolle city: Rouen zip: 76031 country: France name: Emmanuel BESNIER, MD, PhD role: CONTACT lat: 49.44313 lon: 1.09932 facility: Hôpital Rangueil - CHU Toulouse city: Toulouse zip: 31059 country: France name: Stéphanie RUIZ, MD role: CONTACT name: Camille MANE, MD role: CONTACT lat: 43.60426 lon: 1.44367 hasResults: False
<\|newrecord\|> nctId: NCT06338332 id: AW23.050, W19.249 briefTitle: Obstructive Colon Cancer, a Bridge to Surgery in Right Sided Obstructive Colon Cancer acronym: OCCBRIGHT overallStatus: RECRUITING date: 2024-01-01 date: 2025-01 date: 2028-01 date: 2024-03-29 date: 2024-03-29 name: Amphia Hospital class: OTHER briefSummary: Rationale: Approximately 13% (range 10-28%) of all colorectal cancer patients (CRC) present with an acute obstruction. Postoperative mortality after an emergency resection is known for its high risk of morbidity and mortality. Different options can be considered in the management of obstructing right sided CRC: 1) primary resection, simultaneous treatment of obstruction and tumour resection, or 2) staged treatment of the obstruction with secondary resection of the tumour. Currently, in the Netherlands, an emergency resection has been judged to be inferior to postponing surgery. Patients who present with right sided obstructive colon cancer at one of the participating hospitals are subjected to a bridge to surgery (BTS) protocol.
Objective: The primary objective of this study is to determine the feasibility of BTS protocols in right sided obstructive colon cancer and reduce mortality- and morbidity (stoma rates, major- and minor complications) rates in potentially curable patients presenting with acute obstructing colon cancer.
Study design: This is a multicentre, prospective registration study Study population: All patients presenting with high clinical suspicion or histologically proven right sided colon cancer and signs of obstruction of the large bowel.
Intervention: Prospective registration of the implementation of bridge to surgery protocols in patients with (acute) malignant right sided obstruction of the colon, without suspicion of perforation (tumour perforation or blow out) in order to optimize patients preoperatively. The BTS approach encompasses the utilization of either ileostomy creation, stent placement or nasogastric tube for decompression, which is subsequently followed by definitive surgical treatment at a later stage. BTS also involves pre-optimization, prior to the surgical procedure, with the following approach: optimizing the nutritional health status improving the physical health status of the patient.
Main study parameters/endpoints: The primary endpoint is complication-free survival (CFS) at 90 days after hospitalization. Complication is defined here as mortality and/or development of a major complication (Clavien-Dindo classification ≥3). With a total follow up of three years. Secondary endpoints: overall mortality, morbidity (stoma rates, minor complications), in hospital stay, oncologic quality of resection and other occurring adverse events. conditions: Colonic Neoplasms Malignant studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 110 type: ESTIMATED measure: Complication-free survival measure: Complications overall measure: Type of surgical intervention measure: Time till surgery measure: Resection measure: TNM measure: Hospital stay measure: One year stoma rate measure: One year survival rates measure: Disease free survival rates one year measure: Disease free survival rates three years measure: Three year survival rates measure: Tumour type (obstructing, not obstructing), measure: Metastasis preoperative measure: Pre-operative diagnostics measure: Type of bridge-to-surgery measure: Nutrition (TPN/extra nutrition) measure: Consultation of other specialist measure: Gender measure: Age at surgery measure: ASA measure: Bodyweight measure: Height measure: Concomitant and previous therapy measure: C-reactive protein measure: Haemoglobin measure: Laboratory values measure: Leukocytes measure: Prothrombin time measure: Sodium measure: Potassium measure: Glomerular filtration rate measure: Albumin measure: Bilirubin measure: ASAT measure: ALAT measure: LDH measure: ALP measure: Gamma-GT measure: Creatinkinase measure: Phosphate measure: Lactate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amphia Hospital status: RECRUITING city: Breda state: Noord-Brabant zip: 4818CK country: Netherlands name: Elze Lockhorst, Drs. role: CONTACT phone: +31 613723827 email: elockhorst@amphia.nl name: Jennifer Schreinemakers, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 51.58656 lon: 4.77596 hasResults: False
<\|newrecord\|> nctId: NCT06338319 id: 23-048-E briefTitle: Book Sharing for Toddlers With Clefts acronym: BOOST overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-04 date: 2028-08 date: 2024-03-29 date: 2024-03-29 name: Seattle Children's Hospital class: OTHER name: University of Washington name: Nationwide Children's Hospital name: Children's Hospital Los Angeles name: Ohio State University briefSummary: Children with clefts exhibit difficulty with language and literacy compared to children without clefts. However, little is known about interventions to address these difficulties in the cleft population. This study will test the efficacy of a parent-focused dialogic book-sharing intervention for toddlers with isolated cleft palate. The study will use a randomized controlled trial (RCT) design and Intention to Treat (ITT) analyses. Child outcomes include expressive and receptive language. Parent outcomes of interest include the frequency and quality of shared reading interactions. To assess mechanisms of action, the study will test whether changes in child outcomes are mediated by changes in parents' behavior. Analyses will also explore heterogeneity in outcomes to determine whether the intervention is more effective in certain clinical or demographic sub-groups. conditions: Cleft Palate conditions: Cleft Lip and Palate studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 320 type: ESTIMATED name: Book-Sharing for Toddlers with Clefts (BOOST) measure: Expressive One Word Picture Vocabulary Test-Fourth Edition measure: Receptive One Word Picture Vocabulary Test-Fourth Edition measure: Child Language Sample measure: MacArthur-Bates Communicative Development Inventory - Computer Adaptive Test measure: Child Speech Sample - Percent Consonants Correct - Revised, Total Number of Unique Consonants measure: Frequency of Shared Reading measure: Quality of Shared Reading measure: Child Language During Reading sex: ALL minimumAge: 24 Months maximumAge: 32 Months stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06338306 id: 08073421 briefTitle: Tacrolimus and Personalized Therapy to Prevent Acute Rejection Episodes overallStatus: RECRUITING date: 2022-01-07 date: 2022-06-30 date: 2025-06-30 date: 2024-03-29 date: 2024-04-09 name: Fondazione IRCCS Policlinico San Matteo di Pavia class: OTHER briefSummary: Heart transplant is the only effective treatment for people with advanced heart failure.
Post-transplant pharmacological therapies are of fundamental importance for the survival of individuals after surgery: although considerable progress has been made for combined immunosuppressive therapies, acute cellular and especially non-cellular rejection still represents a great challenge for doctors.
To verify the absence of the first signs of acute rejection, the analysis of numerous cardiac biopsies (EMB endomyocardial biopsies) is necessary during the first 12 months following the transplant.
Thanks to these scheduled checks, doctors are able to identify the first symptoms of possible chronic rejection and reduce its episodes.
Since the analysis of biopsies is also based on subjective interpretations, cases of erroneous conclusions are frequent.
The researchers of this study aim not only to analyze the biopsies according to the current best clinical practice, but also to evaluate how much anti-rejection drug is actually contained within them.
This is an analysis that is still little used for this type of transplant, which could provide very useful information to doctors.
The researchers will focus their attention on one drug in particular, tacrolimus, abbreviated to "TAC".
The amount of drug measured in biopsies will be compared with that measured in whole blood samples and in particular blood cells (peripheral blood mononuclear cells: PBMC).
The genetic characteristics of each person play an important role in the success of treatment with the drug. To best interpret the results, all participants will be asked to take a blood sample to identify some characteristics of their DNA that could influence the outcome of tacrolimus therapy. conditions: Heart Transplant Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: Tacrolimus（FK506） measure: Tacrolimus quantification in an unconventional matrix measure: Tacrolimus quantification in PBMCs measure: Tacrolimus quantification in whole blood measure: Genetic profile in heart transplant recipients sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Policlinico San Matteo status: RECRUITING city: Pavia zip: 27100 country: Italy name: Ferrari Alessandra, PharmD role: CONTACT phone: +390382503689 email: alessandra.ferrari@smatteo.pv.it name: Simona De Gregori role: PRINCIPAL_INVESTIGATOR lat: 45.19205 lon: 9.15917 hasResults: False
<\|newrecord\|> nctId: NCT06338293 id: KY20240123-02 briefTitle: Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques acronym: EItoCVP overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2025-05 date: 2024-03-29 date: 2024-03-29 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: Effects of inclisiran + statins vs. statins on the morphology and vascular function of coronary vulnerable plaques, in order to provide a better treatment and more detailed imaging basis for the treatment of coronary vulnerable plaques. conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Inclisiran sodium name: Rosuvastatin measure: The change rate of the thinnest fibrous cap of vulnerable plaque at the target vascular lesion from baseline to one-year follow-up(△ FCT%) measure: The change rate of TAV and plaque load of the target vascular lesion; measure: The change rate of lipid composition of plaque: including the lipid volume , the maximum area and angle of lipid, the length of vulnerable plaque, etc. measure: The change rates of other components of plaque (fiber, calcification, crystal, macrophage) measure: The change rates of lesion OFR and target vessel OFR measure: The change rates of other indexes (low density lipoprotein level, Lp-PLA2, hs-CRP, etc.) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06338280 id: VDW002 briefTitle: Remotely Observed Methadone Evaluation II acronym: ROME II overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2027-05-01 date: 2024-03-29 date: 2024-04-02 name: Sonara Health class: INDUSTRY briefSummary: Methadone is an effective treatment for severe opioid use disorder (OUD), but access is limited due to the requirement of daily observed dosing by most opioid treatment programs (OTPs). Sonara Health designed a HIPAA-compliant web-application called Sonara that features integrated video dosing recording, a tamper-evident seal, and an innovative measurement-based care (MBC) framework called the Opioid Craving Visual Analogue Scale (OC-VAS) to facilitate methadone take-homes while providing evidence of appropriate use and monitoring patient outcomes. Phase II of this SBIR aims to compare Sonara against usual take-homes to assess its impact on retention in care, opioid use, patient outcomes, and costs of care. conditions: Opioid Use Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 100 type: ESTIMATED name: Sonara measure: Retention measure: Take homes received over time measure: Opioid cravings measure: Urine toxicology measure: Opioid withdrawal severity measure: Health-related quality of life measure: Drug Abuse Treatment Costs Analysis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06338267 id: SENS-102-RSRT briefTitle: Validation of Innovative Biosensors for Rett Autonomic Symptom Tracking acronym: VIBRANT overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-03-29 date: 2024-03-29 name: Rett Syndrome Research Trust class: OTHER briefSummary: The VIBRANT study aims to validate biosensors to objectively and directly measure symptoms in Rett syndrome and create confidence in the use of these devices in clinical trials. VIBRANT will use several FDA-cleared wearable biosensors and a non-wearable device to collect symptom data from patients with Rett syndrome for up to 9 weeks. Symptoms of interest include heart rate, breathing, sleep, blood oxygen levels, and movement. Participants will use the biosensors intermittently at home, document device use and symptom status, and will come to the clinic for 1 overnight sleep study. A cohort of up to 10 participants receiving an intervention in a separate clinical trial may also enroll and participate on a custom device schedule for up to 1 year.
The study will provide information on the feasibility and ease of use for families at home, biosensor data will be compared to data collected at the same time from the overnight sleep study to demonstrate how well they work in individuals with Rett syndrome, and Emerald will be developed to include movement as a measurable symptom. conditions: Rett Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Assess breathing rate and apnea (breath holds) with RespiraSense measure: Assess heart rate variability with Vivalink VV330 ECG patch measure: Assess blood oxygen levels with Viatom Kids O2 pulse oximeter ring measure: Validate FDA-cleared Vivalink VV330 ECG patch for heart rate variability metrics in Rett syndrome compared to in-lab PSG measure: Validate ECG-derived breathing compared to in-lab PSG measure: Validate FDA-cleared RespiraSense breathing sensor in Rett syndrome compared to in-lab PSG measure: Validate FDA-cleared Viatom Kids O2 pediatric pulse oximeter ring in Rett syndrome compared to in-lab PSG and/or Nonin wristOx pulse oximeter measure: Validate Emerald ability to reliably measure breathing and sleep compared to in-lab PSG measure: Validate Emerald ability to reliably measure breathing and sleep at home compared to FDA-cleared comparator measure: Develop Emerald ability to measure daytime movement sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Rush University city: Chicago state: Illinois zip: 60612 country: United States name: Study Coordinator role: CONTACT name: Pallavi Patawi, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Boston Children's Hospital city: Boston state: Massachusetts zip: 02115 country: United States name: Study Coordinator role: CONTACT name: David Lieberman, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Baylor College of Medicine city: Houston state: Texas zip: 77030 country: United States name: Study Coordinator role: CONTACT name: Bernhard Suter, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
<\|newrecord\|> nctId: NCT06338254 id: E-10840098-772.02-5416 briefTitle: Efficacy of Percussion Massage Therapy Applied to the Lower Extremity on Pain, Edema in Pregnant Women overallStatus: COMPLETED date: 2022-09-04 date: 2023-06-04 date: 2023-06-10 date: 2024-03-29 date: 2024-03-29 name: Istanbul Medipol University Hospital class: OTHER briefSummary: This study aim is to examine the effect of percussion massage therapy applied to lower extremity on pain, edema, fatigue and quality of life in pregnant women. conditions: Pregnancy Complications conditions: Edema Leg conditions: Physiotherapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The participants are blinded. whoMasked: PARTICIPANT count: 60 type: ACTUAL name: percussion massage therapy measure: The Visual Analog Scale (VAS) measure: Evaluation of edema measure: Fatigue Severity Scale (FSS) measure: Short Form-36 (SF-36) sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Istanbul Medipol University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06338241 id: CPP2021-008391 briefTitle: Osteogenic Action of a Biphasic Bioceramic With Statin in a Third Molar Extraction Model acronym: Galibone overallStatus: RECRUITING date: 2024-03-02 date: 2025-06-02 date: 2025-09-02 date: 2024-03-29 date: 2024-04-03 name: Mario Pérez Sayáns class: OTHER name: Universidad de Murcia briefSummary: The clinical study aims to assess the osteogenic effects of Galibone+ in bone regeneration post-extraction of impacted mandibular third molars. conditions: Bone Loss conditions: Regenerative Inflammation studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Biphasic bioceramic of tricalcium phosphate and hydroxyapatite with simvastatin name: Bovine Hydroxyapatite measure: Bone Regeneration_Reduction in radiolucent volume measure: Bone Regeneration_bone volume measure: Bone Regeneration_bone density measure: Bone Regeneration_Fractal dimension measure: Pain levels through visual analog scale measure: Clinical Inflammation evaluating by presence/absence measure: Healing measured by healing index measure: Post-surgical complications evaluated by presence or absense measure: Oral Health-related Quality of Life measured by OHIP-14 test sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Dentistry of Universidade de Santiago de Compostela status: RECRUITING city: Santiago De Compostela state: A Coruña zip: 15705 country: Spain name: MARIO PEREZ SAYANS GARCIA, PHD, PHD role: CONTACT email: mario.perez@usc.es lat: 42.88052 lon: -8.54569 facility: Faculty of Dentistry University of Murcia status: RECRUITING city: Murcia country: Spain name: FABIO CAMACHO ALONSO, PHD role: CONTACT email: fcamacho@um.es lat: 37.98704 lon: -1.13004 hasResults: False
<\|newrecord\|> nctId: NCT06338228 id: 2023-A02458-37 briefTitle: A New Decisional Tree for the Management of Acetabular Fractures : Monocentric Observational Study acronym: FANAD overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-03-01 date: 2024-03-29 date: 2024-03-29 name: University Hospital, Grenoble class: OTHER briefSummary: Acetabular fractures are challenging fractures to treat. Many fracture patterns occur, in a deep anatomical area surrounded by numerous vascular and nervous elements, generally in a polytraumatic context . A reduction with less than 2 mm of incongruence is generally considered acceptable, limiting post-operative osteoarthritis that could rapidly require total hip arthroplasty. Due to the long learning curve, this surgery is limited to large reference centers
. In the last twenty years, the main series published in the literature are small series due to the rarity of the fractures and their trauma context (loss of follow-up, polytrauma patients...). The large variety of fracture patterns according to the Letournel classification creates a spread in patient distribution and decreases the power of statistical analysis. That is the reason why big series are rare and only a few of them allow significant conclusions . The other studies are meta-analyses with their limitations
The lack of consensus makes it difficult to interpret the results between series, so the investigators developed a decision tree to address this knowledge gap.
The aim of this study is to assess and compare the results of a decisional tree for acetabular fracture in a large cohort of patients from a well-known experimental trauma center. conditions: Management of Acetabular Fractures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 250 type: ESTIMATED measure: The main objective of the study is to evaluate and compare the results of a decision tree for the management of acetabulum fractures (also called acetabulum) in a large cohort of patients from the trauma center at Grenoble University Hospital measure: Define the prognostic factors associated with poor clinical outcomes and total hip replacement surgery measure: Compare clinical and radiological findings with the literature measure: Compare clinical and radiological findings with the literature measure: Compare clinical and radiological findings with the literature measure: Compare clinical and radiological findings with the literature measure: Compare clinical and radiological findings with the literature measure: Propose a new assessment of the traumatic hip joint based on PROMs (Patient Reported Outcomes Measures) via a dedicated digital application (Orthense by Digikare) measure: Evaluation of Outcomes and Complications of Early Weight Bearing in Older Adults sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Grenoble Alpes University Hospital,La tronche status: RECRUITING city: Grenoble zip: 38700 country: France name: Sarah, Pharm D role: CONTACT phone: 0033 4 76 76 75 24 email: SUneisi@chu-grenoble.fr name: Mehdi BOUDISSA, Pr role: PRINCIPAL_INVESTIGATOR lat: 45.16667 lon: 5.71667 hasResults: False
<\|newrecord\|> nctId: NCT06338215 id: UNATI_2024 id: 101097681 type: OTHER_GRANT domain: European Research Council briefTitle: Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality acronym: UNATI overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-06-30 date: 2029-06-30 date: 2024-03-29 date: 2024-03-29 name: Clinica Universidad de Navarra, Universidad de Navarra class: OTHER briefSummary: The goal of this clinical trial is to test two advices on alcohol drinking in more than 10.000 Spanish adult drinkers (men of 50 or more years and women of 55 or more years).
The main question it aims to answer is to test the non-inferiority advice of a moderate alcohol drinking pattern on all-cause mortality and other chronic disease like cardiovascular disease, cancer or type 2 diabetes.
Participants will receive during 4 years an advice to drink alcohol following a Mediterranean Alcohol Drinking Pattern (MADP): consuming alcohol in moderation, avoidance of binge drinking and preference for red wine.
Researchers will compare those who will receive a MADP advice with those who will receive an advice on abstention to see if the advice on MADP is not inferior than the abstention advice to prevent all-cause mortality and other chronic diseases. conditions: All Cause Mortality conditions: Cardiovascular Diseases conditions: Invasive Cancer conditions: Liver Cirrhosis conditions: Type 2 Diabetes conditions: Depression conditions: Dementia conditions: Injury Traumatic conditions: Tuberculosis conditions: Infections studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 10000 type: ESTIMATED name: Moderate Alcohol Drinking Pattern name: Abstention measure: Comparison between groups of the incidence of a global Index of all-cause mortality and other alcohol-related diseases measure: Comparison between groups of the incidence of the most severe outcomes measure: Comparison between groups of invasive cancer incidence with extended follow-up sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Navarra city: Pamplona state: Navarra zip: 31008 country: Spain name: Estíbaliz Goñi, Nutritionist role: CONTACT phone: 34948425600 phoneExt: 80-6596 email: egonioch@unav.es name: Rafael Perez-Araluce, PharmD role: CONTACT phone: +34948425600 phoneExt: 80-6672 email: rperez.21@alumni.unav.es name: Miguel A Martinez-Gonzalez, MD, MPH, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.81687 lon: -1.64323 hasResults: False
<\|newrecord\|> nctId: NCT06338202 id: CV027-1137 briefTitle: Real-World Effectiveness of Mavacamten in Canada acronym: MAVEN overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-31 date: 2024-08-31 date: 2024-03-29 date: 2024-03-29 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: The purpose of this observational, retrospective, physician survey study is to describe the real-world effectiveness and use of mavacamten in participants who initiated treatment for obstructive hypertrophic cardiomyopathy (oHCM) in Canada. conditions: Obstructive Hypertrophic Cardiomyopathy (oHCM) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Mavacamten measure: Change in New York Heart Association (NYHA) functional class following mavacamten treatment initiation measure: Change in left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient following mavacamten treatment initiation measure: Proportion of patients with left ventricular outflow tract (LVOT) with Valsalva maneuver gradient (vLVOT) < 20mmHg following mavacamten treatment initiation measure: Age measure: Sex at birth measure: Ethnicity measure: Employment status measure: Body mass index (BMI) measure: Obstructive hypertrophic cardiomyopathy (oHCM) disease duration measure: Proportion of patients in each New York Heart Association (NYHA) functional class II and III measure: Left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient measure: Left ventricular ejection fraction by 2D echocardiogram (LVEFb) measure: Mavacamten dose regimen measure: Proportion of patients who discontinued mavacamten measure: Duration of treatment prior to mavacamten discontinuation measure: Left ventricular ejection fraction by 2D echocardiogram (LVEF) at the time of mavacamten treatment discontinuation measure: Proportion of patients with left ventricular ejection fraction by 2D echocardiogram (LVEF) < 50% at the time of mavacamten treatment discontinuation measure: Reason for discontinuing mavacamten treatment measure: Functional assessment schedule sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: London Health Science Centre (LHSC) city: London state: Ontario zip: N6A 5A5 country: Canada lat: 42.98339 lon: -81.23304 hasResults: False
<\|newrecord\|> nctId: NCT06338189 id: USuffolk briefTitle: The 5Ad Diet for Functional Bowel Disorders overallStatus: RECRUITING date: 2022-05-08 date: 2025-04-01 date: 2026-04-01 date: 2024-03-29 date: 2024-03-29 name: University of Suffolk class: OTHER briefSummary: The goal of this randomised controlled trial (RCT) is to compare the efficacy of the newly developed 5Ad diet against the widely researched low fermentable oligo-, di-, monosaccharide and polyols (FODMAP) diet in reducing gastrointestinal symptoms associated with functional bowel disorders/food intolerances.
The primary aims of this RCT are to determine:
* Whether the 5Ad diet is at least as effective as the low FODMAP diet in reducing gastrointestinal symptoms associated with FBDs/food intolerances.
* Whether either the 5Ad diet or the low FODMAP diet are effective in reducing mental and physical fatigue.
To achieve the above aims, an RCT will be conducted with the 5Ad diet in one arm vs the active phase of the low FODMAP diet in the other arm, in a cross-over design with a 7 days washout phase in between. Both dietary protocols will be followed by each participant for 7 days.
Researchers will compare the results from the 2 dietary protocols in order to ascertain the superiority of one over the other in regards to 6 gastrointestinal symptoms (abdominal pain, bloating, flatulence, bowel urgency, straining and incomplete defecation), stool form and frequency of defecation. conditions: Functional Bowel Disorder conditions: Irritable Bowel Syndrome conditions: Food Intolerance conditions: Food Intolerance Syndromes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: The 5Ad Diet name: The Low FODMAP Diet measure: Abdominal Pain measure: Abdominal Bloating measure: Flatulence measure: Bowel Urgency measure: Straining measure: Incomplete Defecation measure: Stool Form measure: Frequency of defecation measure: Fatigue measure: Mental Fatigue measure: Physical Fatigue sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Suffolk status: RECRUITING city: Ipswich state: Suffolk zip: IP4 1QJ country: United Kingdom name: Camilla Bunn role: CONTACT phone: +44 1473 338332 email: c.bunn2@uos.ac.uk name: Dr Fandi Ibrahim role: CONTACT phone: +44 1473 338623 email: f.ibrahim@uos.ac.uk name: Camilla Bunn role: PRINCIPAL_INVESTIGATOR name: Dr Fandi Ibrahim role: SUB_INVESTIGATOR name: Dr Federica Masieri role: SUB_INVESTIGATOR name: Martin Sinclair role: SUB_INVESTIGATOR lat: 52.05917 lon: 1.15545 hasResults: False
<\|newrecord\|> nctId: NCT06338176 id: Pro00128904 briefTitle: Optimizing the Management of Staphylococcus Aureus Bacteremia (OPTIMUS-SAB) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-10-30 date: 2026-04-30 date: 2024-03-29 date: 2024-04-22 name: University of Alberta class: OTHER name: Alberta Health services briefSummary: Staphylococcus aureus bacteremia (SAB) is associated with high morbidity and mortality rates with an incidence disproportionately higher in vulnerable populations. Management according to evidence-based care parameters, in particular Infectious Diseases (ID) consultation, is associated with improved mortality. SAB management is suboptimal in Alberta compared to other jurisdictions. An Alberta-based pilot study confirmed that timely recommendations to optimize SAB care, including ID consultation, was associated with improved adherence to all evidence-based quality-of-care indicators.
Leveraging this pilot work, the investigators aim to implement OPTIMUS-SAB, an enhanced model of the pilot, to optimize and standardize SAB management across Alberta. The implementation study will be a zone-based acute care site stepped wedge design. OPTIMUS-SAB will consist of a centralized SAB care team whom will receive automated notification of all blood cultures positive for S. aureus allowing them to review the patient's medical chart and make preliminary management recommendations according to an evidence-based care bundle.
The investigators will evaluate adherence to evidence-based SAB quality-of-care indicators before and after OPTIMUS-SAB implementation and expect this to improve with a resultant reduction in duration of bacteremia, length of stay, readmission rates, and mortality. In turn, this will translate into cost savings for the health care system. conditions: Staph Aureus Bacteremia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 1800 type: ESTIMATED name: OPTIMUS-SAB clinical care pathway measure: Adherence to quality-of-care indicators measure: Length of stay measure: Hospital re-admission rates measure: All-cause mortality measure: In hospital mortality measure: Costing evaluation measure: Implementation evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06338163 id: POSSIBLE 1.6 briefTitle: Polihexanide SSIs Measures Bundle (PSMB) During Enhanced Recovery After Major Digestive Surgery acronym: POSSIBLE overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-06-30 date: 2025-09-30 date: 2024-03-29 date: 2024-04-04 name: Marco Catarci class: OTHER name: Associazione Chirurghi Ospedalieri Italiani briefSummary: This is a randomized controlled, prospective, multicenter superiority trial with two parallel treatment groups and single blinding (local investigators performing postoperative follow up will be blinded for group allocation), with prospective enrollment planned from July 2024 to June 2025 in 20 Italian surgical centers. All patients undergoing elective major gastro-intestinal (GI) tract surgery (upper GI, HPB, \& lower GI) will be included in a prospective database after written informed consent. A total of 2,000 patients is expected based on a mean of 100 cases per center. conditions: Surgical Site Infection conditions: Surgical Procedures, Operative studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled prospective multicenter primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Assessor of the primary outcome will be masked concerning arm allocation whoMasked: OUTCOMES_ASSESSOR count: 2000 type: ESTIMATED name: Polihexanide-based bundle name: Standard bundle measure: Surgical Site Infections rate measure: Incisional (superficial and deep) Surgical Site Infections rate measure: Infectious morbidity rates measure: Anastomotic leakage rates measure: Overall morbidity rates measure: Major morbidity rates measure: Comprehensive complication index measure: Overall length of postoperative hospital stay measure: Readmission rates measure: Patient-reported outcome measures sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OSpedale Santa Maria Annunziata city: Firenze state: FI zip: 50012 country: Italy name: Marco Scatizzi, MD role: CONTACT phone: 393474137246 email: marcoscatizzi@gmail.com lat: 43.77925 lon: 11.24626 facility: Ospedale Civile di Macerata city: Macerata state: MC zip: 62100 country: Italy name: Massimo Sartelli, MD role: CONTACT phone: +393405369701 email: massimosartelli@gmail.com lat: 43.29789 lon: 13.45293 facility: Ospedale Sandro Pertini city: Roma state: RM zip: 00157 country: Italy name: Marco Catarci, MD role: CONTACT phone: +393298610040 email: marco.catarci@aslroma2.it name: Michele Benedetti, MD role: SUB_INVESTIGATOR name: Paolo Ciano, MD role: SUB_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False
<\|newrecord\|> nctId: NCT06338150 id: STUDY-23-00503 id: GCO 19-0175 type: OTHER_GRANT domain: Icahn School of Medicine at Mount Sinai id: 5R01CA244899 type: NIH link: https://reporter.nih.gov/quickSearch/5R01CA244899 briefTitle: Precision Medicine Study overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-06 date: 2024-03-29 date: 2024-03-29 name: Icahn School of Medicine at Mount Sinai class: OTHER name: National Cancer Institute (NCI) briefSummary: This will be a 2 year study to evaluate and improve cancer sequencing as applied to the characterization of tumor molecular make-up and the identification of novel therapeutics (n=100). Participants who will undergo tumor biopsy for management of multiple myeloma (MM) will self-refer to the study or be referred by their treating physician. Participants will initially meet with a clinician to review study consents and provide medical, medication, and family history information. After informed consent, biospecimen samples from peripheral blood, cheek swab, and tumor samples from bone marrow (aspirate and biopsy), peripheral blood, or any mass/fluid containing tumor cells will be obtained (from procedures indicated as part of their standard oncology care) for cancer sequencing (CS) (whole exome sequencing of germline and tumor genomes, RNA sequencing of tumor transcriptome, single cell, and CyTOF analysis). CS data will be interpreted via somatic variation identification, network modeling, and cancer transcriptome profiling to facilitate mapping activity levels of genes to networks and for identifying genes activated or dysregulated in cancer cells. Sequencing and analysis will be performed at the Genomics Core Facility at the Icahn School of Medicine at Mount Sinai. In instances where internal sequencing capabilities do not allow for certain types of analysis, de-identified samples or data may be sent out to third parties for additional analysis. The study will be using GenPath, a division of BioReference® Health, LLC for this project which is a CLIA certified lab. All genetic tests will be performed in a CLIA certified lab and all tests will be FDA or NYS approved. The RNA Sequencing test will receive NYS Department of Health (Wadsworth Center) approval before results are provided to physicians and patients. Samples will be de-identified and processed by the Mount Sinai Human Immune Monitoring Core (HIMC) before being sent to an external CLIA-certified lab for sequencing and analysis. Interpretation will be performed by a multidisciplinary team that includes genomicists, pathologists, and clinicians familiar with the particular cancer diagnosed in the participant. Once results are available, they will be shared with the participant and treating physician during a follow-up results session and any findings obtained explained. This study is not intended to implement findings, only to report them. conditions: Multiple Myeloma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Total number of somatic Single-nucleotide variants (SNVs) per patient measure: Total number of somatic insertions (INS) per patient measure: Total number of somatic deletions (DEL) per patient measure: Number of SNVs per megabase of the MM genome measure: Number of INS per megabase of the MM genome measure: Number of DEL per megabase of the MM genome measure: Number of mutations per megabase among MM subgroups measure: Number of mutations per megabase among genomic regions for all MM and mutational subgroups measure: Gene mutations identified measure: Chromosomal abnormalities identified measure: Molecular signatures identified measure: Established Prognostic markers identified measure: Somatic variants identified as targets of FDA-approved drugs (pharmacogenomics variant data) measure: Network-informed key driver variants identified measure: Transcriptome variations identified measure: Germline mutations identified in cancer predisposition genes measure: FDA approved drugs available that block enzymes produced in those pathways identified measure: Treatment recommended by computational pipeline based on patient's clinical and genetic measure: Germline whole exome sequencing profile measure: Tumor genome whole exome sequencing profile measure: Tumor transcriptome profile measure: Single-cell sequencing profile measure: Cytometric profile measure: Signaling Pathways associated measure: Enzymes associated with each signaling pathway identified measure: Improvement of cancer sequencing-guided treatment recommendations by machine learning sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mount Sinai Health System city: New York state: New York zip: 10029 country: United States name: Cesar Rodriguez Valdes, MD, PhD role: CONTACT email: Cesar.Rodriguez@mssm.edu name: Katherine Vandris role: CONTACT email: Katherine.Vandris@mssm.edu name: Cesar Rodriguez Valdes role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
<\|newrecord\|> nctId: NCT06338137 id: 4-2024urol briefTitle: Comparison of High and Low Pulse Energy Dusting Protocols Using Holmium: YAG-laser in Flexible Ureteroscopy for Renal Stones Treatment overallStatus: COMPLETED date: 2022-08-25 date: 2023-08-25 date: 2024-01-01 date: 2024-03-29 date: 2024-04-04 name: Menoufia University class: OTHER briefSummary: Rcompare high-energy versus low-energy laser settings in renal stone lithotripsy using low power machines) Holmium YAG 30 watts, examining their respective advantages, limitations, and overall efficacy. conditions: Renal Stone studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 160 type: ACTUAL name: Holmium Yag laser measure: Stone free rates measure: Preoperative complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hossam Kandeel city: Shibīn Al Kawm state: State Or Province zip: 32511 country: Egypt lat: 30.55258 lon: 31.00904 hasResults: False
<\|newrecord\|> nctId: NCT06338124 id: David Ibrahim briefTitle: Value of Laboratory Biomarkers in Prediction of Outcome in Septic Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-15 date: 2025-04-01 date: 2024-03-29 date: 2024-03-29 name: Egymedicalpedia class: INDUSTRY briefSummary: Sepsis is defined as a dysregulated host response to infection . Despite ongoing efforts, both the incidence and mortality of sepsis have demonstrated limited reductions over the past years,There are several biomarkers that have already been studied for the early diagnosis of sepsis. Some of these markers can be used in risk prediction and monitoring the outcome of sepsis .
Some of these markers as procalcitonin and CD14, are costly and not feasible options for low- and middle-income countries . While other biomarkers are feasible and accessible to be evaluated as Triglyceride\\glucose index (TyG) , Relative Distributive Width of red blood corpuscles to albumin ratio (RAR), C-reactive protein,Neutrophile \\Lympocyte ratio and serum lactate levels . conditions: Sepsis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Triglyceride glucose index measure: Mortality sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Assuit University Hospital city: Assiut country: Egypt name: Dina Hamad, Assist.Prof role: CONTACT phone: +201063040703 email: dinaalihamad@yahoo.com lat: 27.18096 lon: 31.18368 hasResults: False
<\|newrecord\|> nctId: NCT06338111 id: 2461 briefTitle: Interventions Meant to Improve the Outcome of Critical Care Patients in the ED overallStatus: COMPLETED date: 2020-11-09 date: 2022-12-06 date: 2023-04-30 date: 2024-03-29 date: 2024-04-16 name: Iuliu Hatieganu University of Medicine and Pharmacy class: OTHER briefSummary: This study aims to identify the prognostic role of procalcitonin (PCT), soluble Triggering Receptor Expressed on Myeloid Cells-1 (sTREM-1), the soluble form of the urokinase plasminogen activator receptor (suPAR), highly sensitive C-reactive protein (hs-CRP), Interleukin-6 (IL-6), and azurocidin 1 (AZU1) in 28-day mortality for patients with sepsis in Emergency Department. conditions: Sepsis Syndrome conditions: Emergency Department conditions: Biomarker studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 67 type: ACTUAL name: ELISA Sepsis Biomarkers dosage measure: Can we better predict mortality in septic patients from the Emergency Department? sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cluj County Hospital Emergency Department city: Cluj-Napoca state: Cluj zip: 400006 country: Romania lat: 46.76667 lon: 23.6 hasResults: False
<\|newrecord\|> nctId: NCT06338098 id: HFNVSH.001 briefTitle: Effect of an 8-week Heartfulness Meditation Program on Burnout and Stress at Veterinary Specialty Hospital overallStatus: COMPLETED date: 2023-02-28 date: 2023-10-02 date: 2023-10-02 date: 2024-03-29 date: 2024-04-02 name: Heartfulness Institute class: OTHER name: Angell Animal Medical Center briefSummary: This quantitative study assesses the effects of meditation and relaxation practices on the reduction of burnout and stress in veterinary care workers. Assessments at baseline will include the Perceived Stress Scale (PSS) and Maslach Burnout Toolkit, and the same questionnaires were collected in Week 8 and Week 16. The Google form questionnaire will ask the participant for their email address. The form will also include a question eliciting interest in participation in the 8-weeks Heartfulness Meditation program. The program will include tools that promote a heart-based nurturing environment focusing on relaxation, and tools to cope with burnout. conditions: Stress conditions: Burnout, Professional studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 74 type: ACTUAL name: 8-week wellness and relaxation meditation program measure: Assess the current level of Anxiety measure: Changes level of Stress measure: Assess the current level of Burnout measure: Changes level of Burnout sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Angell Animal Medical Center, city: Boston state: Massachusetts zip: 02130 country: United States lat: 42.35843 lon: -71.05977 hasResults: False
<\|newrecord\|> nctId: NCT06338085 id: meryemvrlshn00000000002 briefTitle: The Effect of Emotional Freedom Technique (EFT) on Depression in Postmenopausal Women overallStatus: RECRUITING date: 2024-03-11 date: 2024-05-04 date: 2024-05-20 date: 2024-03-29 date: 2024-04-05 name: Meryem Vural Şahin class: OTHER briefSummary: The aim of this study is to determine the effect of EFT (Emotional Freedom Technique), a nonpharmacological method, on menopausal symptoms and depression in postmenopausal women. By determining the effectiveness of the Emotional Freedom Technique, the applicability of non-pharmacological method treatment in women with depression and menopausal symptoms in postmenopausal period will be proven. As a result of the study, if a positive effect on menopausal symptoms and depression is found in women with EFT, it can be recommended as an evidence-based alternative method in midwifery and nursing care. conditions: Menopause studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: the groups with a conventional therapy control group primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: emotional liberation technique measure: Beck Depression Scale measure: Menopause Rating Scale (MRS) sex: FEMALE maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: family health center no. 1 in Çayyolu status: RECRUITING city: Ankara state: Çankaya country: Turkey name: MERYEM VURAL ŞAHİN role: CONTACT phone: 05535344779 email: meryemyasam@gmail.com name: Meltem UĞURLU role: PRINCIPAL_INVESTIGATOR name: Derya Yüksel KOÇAK role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06338072 id: DIABETEXX/1 briefTitle: Impact of the Menstrual Cycle in Reproductive Aged Women With Type 1 Diabetes Using a Closed Loop System (DIABETEXX/1). acronym: DIABETEXX/1 overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-03 date: 2025-01-01 date: 2025-08-01 date: 2024-03-29 date: 2024-04-23 name: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal class: OTHER name: Universitat Politècnica de València briefSummary: The aim of this observational study is to assess the effectiveness of automatic insulin infusion in responding to changes in insulin sensitivity throughout various phases of the menstrual cycle in a cohort of reproductive-aged women with type 1 diabetes, using an advanced closed-loop system. By gaining insights into both the limitations and effectiveness of this adaptation, we aim to inform the enhancement of control algorithms and learning strategies within closed-loop systems. This research is especially vital for addressing the distinct challenges that women commonly encounter in maintaining glycemic control. conditions: Type 1 Diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 119 type: ESTIMATED measure: Time in range measure: Time below range measure: Time above range measure: Caloric intake measure: Temperature measure: Photoplethysmography measure: Accelerometry sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Lía Nattero-Chávez city: Madrid zip: 28034 country: Spain lat: 40.4165 lon: -3.70256 hasResults: False
<\|newrecord\|> nctId: NCT06338059 id: Gulcanozturkchatipchousein briefTitle: Relationship Between Vitamin D and Vitamin B12 Levels and Neuropathic Pain in Lipedema overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-01 date: 2024-05-01 date: 2024-06-01 date: 2024-03-29 date: 2024-03-29 name: Fatih Sultan Mehmet Training and Research Hospital class: OTHER briefSummary: Lipedema is a disease characterized by bilateral abnormal fat deposition in the upper and lower extremities. Pain is a common symptom in lipedema.Vitamin D plays an important role in chronic pain. Vitamin B have analgesic role in some neuropathic pain conditions.This study aimedto evaluate the relationship between vitamin D and vitamin B12 levels and neuropathic pain in lipedema. conditions: Vitamin D Deficiency conditions: B12 Deficiency Vitamin conditions: Lipedema studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 200 type: ACTUAL name: Vitamin B12 Level measure: Vitamin B12 Level measure: 25 OH Vitamin D Level sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gulcan Ozturk city: Istanbul zip: 34752 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06338046 id: EAShi23M01 briefTitle: In Vivo Evaluation of NC65 - Vita D-Light SKIN ADAPTOGEN AND SEBUM BALANCE EFFICACY acronym: Shitake overallStatus: COMPLETED date: 2023-10-01 date: 2023-11-15 date: 2023-12-22 date: 2024-03-29 date: 2024-03-29 name: Ritamaria Di Lorenzo class: OTHER briefSummary: This double-blind placebo-controlled study intends to confirm skin adaptogen and sebum balance efficacy of the investigational active ingredient NC65 - Vita D-Light, transmitted at 0.5% w/w in a topical cosmetic formulation, on a panel of healthy human subjects.
The study is performed by RD Cosmetics - University of Naples Federico II, from October to June 2024. The study involves female and male subjects, scheduled for eligibility screening at the study site. A total of 40 subjects were enrolled, and randomly divided into 2 groups: 20 subjects received the active treatment (cosmetic formulation with 0.5 %w/w NC65 - Vita D-Light) and 20 subjects the placebo one.
The cosmetic effectiveness of the products was instrumentally detected, using innovative, non-invasive and worldwide recognized devices for skin analysis, like:
* Corneometer CM 825 (C+K electronic GmbH) detects water's content of the stratum corneum.
* Tewameter® TM Hex (C+K electronic GmbH) detects the trans-epidermal water loss (TEWL).
* Sebumeter SM 815 accurately and reproducibly measures the level of sebum on the skin surface.
* Visia VISIA® (Canfield Scientific, Inc.) for skin surface assessment.
The monitored skin features parameters will be check after 1 hour (T1h) for the adaptogen test, and after 7, 14 and 28 days (T7 -T14-T28), for the detox test. Panelists will complete the self-assessment questionnaire at the end of the study period (T28). conditions: SKIN ADAPTOGEN AND SEBUM BALANCE EFFICACY studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2 parallel arm, double blind, randomized, placebo-controlled primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: neither the patient nor the investigator knows who is getting which treatment. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Corthellus Shiitake(Mushroom) Extract name: Placebo measure: Soothing Test measure: Detox and adaptogen Test sex: ALL minimumAge: 25 Years maximumAge: 40 Years stdAges: ADULT facility: RD Cosmetics Lab - Pharmacy Department, University of Naples Federico II city: Naples zip: 80131 country: Italy lat: 40.85216 lon: 14.26811 hasResults: False
<\|newrecord\|> nctId: NCT06338033 id: 2024-03-23 briefTitle: Prognostic Study of Visceral Fat and Heart Failure With Preserved Ejection Fraction overallStatus: COMPLETED date: 2020-09-19 date: 2023-08-28 date: 2023-11-30 date: 2024-03-29 date: 2024-03-29 name: Chongqing Medical University class: OTHER briefSummary: Obesity and heart failure with preserved ejection fraction (HFpEF) have multiple pathologic associations that affect the prognosis of HFpEF. Chinese people are more prone to visceral obesity, resulting in varying degrees of true obesity in individuals with the same body mass index (BMI). There are no prognostic studies of VFA/BMI in the HFpEF population. conditions: Heart Failure With Preserved Ejection Fraction and Visceral Fat studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 298 type: ACTUAL measure: All-cause mortality measure: Rehospitalization for heart failure measure: Composite endpoints of all-cause mortality and rehospitalization for heart failure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Chongqing Medical University city: Chongqing country: China lat: 29.56278 lon: 106.55278 hasResults: False
<\|newrecord\|> nctId: NCT06338020 id: RHPT/0022/0042 briefTitle: Adaptive Variable-Resistance Training in Pediatric Survivors of Acute Lymphoblastic Leukemia overallStatus: COMPLETED date: 2022-12-29 date: 2024-01-04 date: 2024-01-04 date: 2024-03-29 date: 2024-03-29 name: Cairo University class: OTHER briefSummary: This study was designed to investigate the effect of eight weeks of adaptive variable-resistance training (Adaptive-VRT) on chemotherapy-induced sarcopenia, fatigue, and functional restrictions in a convenience sample of pediatric survivors of acute lymphoblastic leukemia (ALL). Sixty-two pediatric survivors of ALL were randomly allocated to the experimental group (n = 31, received the adaptive variable-resistance training) or the Control group (n = 31, received standard physical therapy care). Both groups were assessed for muscle mass, strength, fatigue, and functional capacity before and after treatment. conditions: Acute Lymphoblastic Leukemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A prospective, dual-arm, randomized controlled trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment. whoMasked: OUTCOMES_ASSESSOR count: 62 type: ACTUAL name: Adaptive variable-resistance training name: Standard physical therapy measure: Thigh muscle thickness measure: Muscle strength measure: Fatigue measure: Six-minute walk test measure: 4x10 meter Shuttle Run test measure: Timed up and down stairs test sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Ragab K. Elnaggar city: Al Kharj state: Riyadh country: Saudi Arabia lat: 24.15541 lon: 47.33457 hasResults: False
<\|newrecord\|> nctId: NCT06338007 id: 2012-KAEK-15/2702 briefTitle: Relationship Between Hand Dynamometer Measurements, PFT, and mFI With Postoperative Outcomes overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-09-01 date: 2025-01-01 date: 2024-03-29 date: 2024-04-17 name: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital class: OTHER briefSummary: The study will take place at SBÜ Ankara Atatürk Sanatorium Training and Research Hospital and will include 100 patients over the age of 40 who are scheduled for lung malignancy surgery after 01 April 2024. Informed consent will be obtained from all patients, who will be assigned a number from 1 to 100.
For patients over 40 years of age who are scheduled to undergo lung malignancy resection surgery, demographic data including age, gender, height, weight, body mass index (BMI), diagnosis, comorbidities, and ASA (American Society of Anaesthesiologist) score will be recorded. In addition, hand grip strength measurement, pulmonary function test, and modified frailty index (a scoring system that includes 11 parameters) will be recorded prior to surgery. Intraoperative and postoperative complications will be documented. The duration of the patient's stay in the intensive care unit, chest tube removal, length of hospital stay, and postoperative complications will also be recorded. A follow-up call will be made to the patient by the responsible researcher 90 days after the operation to inquire about any complications that may have developed within that time frame.
The study aims to investigate the relationship between preoperative hand grip strength measurement, pulmonary function test analysis (PFT), and modified frailty index with the duration of intensive care unit stay, chest tube withdrawal time, hospital stay, and postoperative complications in patients undergoing lung resection due to malignancy. conditions: Complication,Postoperative conditions: Lung Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Hand Dynamometer name: Pulmonary Function Test name: Modified Frailty Index measure: Complication sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Atatürk Sanatorium Training and Research Hospital city: Ankara state: Keçiören zip: 06290 country: Turkey name: Gülay ÜLGER, specialist role: CONTACT phone: 05059532122 phoneExt: +9 email: gulayulger@gmail.com name: Onur KÜÇÜK, specialist role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06337994 id: AUH-Neurol-TBI_2024 briefTitle: Memantine Hydrochloride for Treatment of Cognitive Dysfunction Due to Traumatic Brain Injury overallStatus: RECRUITING date: 2024-01-01 date: 2024-06-01 date: 2024-12-30 date: 2024-03-29 date: 2024-03-29 name: Assiut University class: OTHER briefSummary: Posttraumatic consequences are common causes of disability and long-term morbidity. They include cognitive dysfunction, seizures, headache, dizziness, fatigue, sensory deficits, neurodegeneration and psychiatric disorders (e.g. posttraumatic stress disorder, depression, anxiety, etc). Diffuse axonal injury and disruption of normal neuronal function are the most common and important pathologic features of traumatic primary closed head injury. depression, anxiety, etc). Excitotoxicity and apoptosis caused by activation of N-methyl-D-aspartate (NMDA) glutamate receptors, are two main suggested mechanisms of traumatic neuronal cell death and posttraumtic neurologic adverse consequences. Experimental and clinical studies have demonstrated that memantine hydrochloride, NMDA-type glutamate receptor antagonist, could have beneficial effect in treatment of posttraumatic cognitive dysfunction. Memantine may contribute to cognitive improvements in TBI by decreasing the synaptic 'noise' resulting from excessive NMDA receptor activation, inhibition of β-amyloid mediated toxicity and readjustment of the balance between inhibition and excitation on neuronal networks in the central nervous system (CNS). conditions: Treatment of Posttraumatic Cognitive Dysfunction studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: parallel assignment primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Memantine Hydrochloride measure: The severity of traumatic brain injury (TBI) measure: The symptoms of depression measure: The symptoms of anxiety measure: The cognitive function measure: Quality of life measure: The cognitive function sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Assiut University, Faculty of Medicine, Hospital of Neurology, Psychiatry and Neurosurgery status: RECRUITING city: Assiut zip: 71516 country: Egypt name: Sherifa A Hamed, M.D. role: CONTACT phone: +201115324560 email: hamedsherifa@aun.edu.eg name: Sherifa A Hamed, MD role: PRINCIPAL_INVESTIGATOR lat: 27.18096 lon: 31.18368 hasResults: False
<\|newrecord\|> nctId: NCT06337981 id: 21DE20901 briefTitle: Efficacy and Safety of AJU-S56 in Dry Eye Syndrome Patients overallStatus: COMPLETED date: 2021-11-22 date: 2022-06-14 date: 2022-11-28 date: 2024-03-29 date: 2024-04-29 name: AJU Pharm Co., Ltd. class: INDUSTRY name: GL Pharm Tech Corporation briefSummary: This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56) compared to control drug(vehicle) in Patients with Dry Eye Disease. conditions: Dry Eye Syndromes studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 99 type: ACTUAL name: (AJU-S56 5% and placebo) name: AJU-S56 5% name: Placebo(Vehicle) measure: Total corneal staining score (TCSS) measure: LGCSS measure: TFBUT sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AJU Pharm Co., Ltd. city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
<\|newrecord\|> nctId: NCT06337968 id: Circum-Psoas Block LN briefTitle: CPB for Arthroscopic Hip Surgery overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2025-05-31 date: 2024-03-29 date: 2024-04-19 name: The Second Hospital of Shandong University class: OTHER briefSummary: Arthroscopic hip surgery is being increasingly performed to treat both intraarticular and extraarticular hip diseases. Despite the minimally invasive approach, patients undergoing arthroscopic hip surgery still suffer severe pain due to the complex nature of hip innervation. Postoperative pain reduces patient satisfaction and delay patient recovery and discharge. The efficacy of regional anesthesia techniques in postoperative pain management have been proved in various surgeries. However, it remains controversial whether or not peripheral nerve blocks can significantly improve postoperative analgesia after hip arthroscopy.
Several studies have shown that the fascia iliac block cannot improve postoperative analgesia for hip arthroscopy because it blocks only some branches of the lumbar plexus but not the sacral plexus. Circum-Psoas Block (CPB) which has been defined in recent years is able to block the lumbar plexus nerves as well as sacral plexus such as the sciatic, superior gluteal, and inferior gluteal nerves. Therefore, the investigators predict that it can provide effective postoperative analgesia for hip arthroscopy. In this study, the researchers aim to investigate the effectiveness of CPB in hip arthroscopy. conditions: Acute Pain conditions: Opioid Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 74 type: ESTIMATED name: Circum-psoas Block name: Sham block measure: pain severity at 6 hours postoperatively measure: Postoperative opioid consumption measure: Postoperative nausea and vomiting measure: neurologic evaluation measure: Patient satisfaction sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06337955 id: 20170007596 briefTitle: Non Primary HCMV Infection: Natural History and Immune Response overallStatus: ACTIVE_NOT_RECRUITING date: 2017-06-06 date: 2024-09 date: 2024-12 date: 2024-03-29 date: 2024-04-01 name: Foundation IRCCS San Matteo Hospital class: OTHER name: Università degli Studi di Pavia name: Merck Sharp & Dohme LLC name: Fondazione Regionale per la Ricerca Biomedica (FRRB) - Regione Lombardia briefSummary: The goals of this observational study are: i) investigate the natural history of non-primary (i.e. reactivation and reinfection) HCMV infection in HCMV-seropositive Italian women and the relevant humoral and cell-mediated immune response; ii) reliably distinguish between reactivation and reinfection.
Prerequisite of the study is the availability of a maternal HCMV strain at baseline (original strain) to which subsequent strains detected during follow-up are compared in order to distinguish between reactivation (original strain) or reinfection (new strain).
To increase the likelihood of exposure to different HCMV strains, the study population is restricted to mothers of children attending day care centers. conditions: Cytomegalovirus Infections studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 204 type: ACTUAL measure: HCMV non-primary infection (reinfection or reactivation). measure: HCMV-specific humoral and cell-mediated immune response during non-primary infection. measure: Maternal behaviours and occurrence of non-primary infection measure: Potential use of saliva swabs for antibody determination. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Policlinico San Matteo city: Pavia state: PV zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 hasResults: False
<\|newrecord\|> nctId: NCT06337942 id: 23-001621 briefTitle: Deceased Donor Bladder or Combined Kidney-bladder Transplantation: a Phase 0 First-in-human Study overallStatus: RECRUITING date: 2024-04-01 date: 2025-04 date: 2027-04 date: 2024-03-29 date: 2024-03-29 name: University of California, Los Angeles class: OTHER briefSummary: The goal of this clinical trial is to demonstrate the feasibility of bladder transplantation in patients with terminal bladder diseases who would benefit from a new bladder or a combined kidney and bladder transplant. The main questions it aims to answer are:
* Is human bladder transplantation feasible and safe?
* How will the new bladder function in terms of storage and emptying?
Participants will undergo a bladder-only or combined kidney and bladder transplantation. They will then be followed for two years to evaluate the efficacy, safety, and functionality of the bladder transplant. conditions: Bladder Disease conditions: Bladder, Neurogenic conditions: Bladder Cancer conditions: Kidney Failure studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: Bladder Transplantation name: Combined Kidney and Bladder Transplantation measure: Demonstrating the technical success of bladder or combined kidney-bladder transplantation measure: Incidence of adverse events after bladder or combined kidney-bladder transplantation measure: Incidence of immune rejection after bladder or combined kidney-bladder transplantation measure: Evaluate the functionality of the transplanted bladder sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCLA status: RECRUITING city: Los Angeles state: California zip: 90095 country: United States name: Magdalena Mendez-Smith role: CONTACT phone: 310-267-7727 email: mmendezsmith@mednet.ucla.edu name: Nima Nassiri, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False
<\|newrecord\|> nctId: NCT06337929 id: Ethics Approval: n. 6.683.936 briefTitle: Effects of Capoeira on the Physical and Psychological Performance of Adults overallStatus: ENROLLING_BY_INVITATION date: 2024-04-01 date: 2024-07-15 date: 2024-12-13 date: 2024-03-29 date: 2024-03-29 name: Universidade Federal do vale do São Francisco class: OTHER briefSummary: Regular physical activity (PA) promotes benefits for both physical and mental health. Among the numerous PA\'s with a collective nature that can add to the existing recommendations, combat sports training interventions are viable alternatives since they integrate benefits in different aspects for health. In this way, capoeira can be a strategy for the prescription of exercise, aiming to serve participants collectively and maintaining the adherence of this practitioner to the intervention. However, little is known about this issue. So, the aim of the present study is to verify the effect of 12 weeks of capoeira training on the physical performance and psychological aspects of previously physically inactive adults. conditions: Training conditions: Mental Health conditions: Physical Fitness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: CAPOEIRA TRAINING name: CONTROL GROUP measure: Change from baseline in aerobic fitness (maximal oxygen uptake and anaerobic threshold) at week 12 measure: Change from baseline in anaerobic fitness (Peak, average and minimum power in the Wingate test) at week 12 measure: Change from baseline in muscle strength (Horizontal Leg Press) at week 12 measure: Change from baseline in muscle power (Vertical Jump Tests from Squat Jump and Counter Movement Jump) on force platform at week 12 measure: Change from baseline in balance (Center of Pressure) on force platform at week 12 measure: Change from baseline in motor coordination (Test of Gross Motor Development) at week 12 measure: Change from baseline in Emotional Intelligence to sport (Likert-type scales with 26 items) at week 12 measure: Change from baseline in Motivation for Sport II (Likert-type scales with 18 items) at week 12 measure: Change from baseline in Quality of life measuring by Questionnaire of Word Health Organization (WHOQOL-bref) at week 12 sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: UNIVASF city: Petrolina state: Pernambuco zip: 56300000 country: Brazil lat: -9.39861 lon: -40.50083 hasResults: False
<\|newrecord\|> nctId: NCT06337916 id: 2021/16-01 briefTitle: The Effect of Cervical Stabilization Exercises on the Cervical Proprioception in Patients With Chronic Neck Pain overallStatus: COMPLETED date: 2022-10-07 date: 2022-11-25 date: 2023-01-30 date: 2024-03-29 date: 2024-04-02 name: Şenay Özdolap class: OTHER name: Zonguldak Bulent Ecevit University briefSummary: Neck pain is one of the most common musculoskeletal complaints and its prevalence is between 10-22%. Approximately half of all individuals will experience a clinically important neck pain episode over the course of their lifetime. Neck pain is categorized by duration as acute, subacute and chronic neck pain (acute, \<6 weeks; subacute, ≤3 months; chronic, \>3 months). Chronic neck pain is more common in women and its incidence increases with age. Cervical disc herniation, cervical spondylosis, cervical stenosis, myofascial pain syndrome, cervical instability, whiplash injury, Klippel feil syndrome, thoracic outlet syndrome, cervical sprain, cervical strain, tumors, rheumatic diseases, torticollis, inflammatory neck pain are the main causes.
Anterior tilt of the head is a common posture in neck pain. In this posture, the upper cervical vertebrae are extension, the lower cervical vertebrae are flexion and the cervical lordosis is decreased. With neck pain, inhibition occurs in the deep neck flexor (longus coli and capitis) and extensor (multifidus, rotator, semispinalis) muscles, increased fat infiltration, deterioration in type 1 and 2 fiber ratios, and muscle atrophy. The risk of micro and macro trauma increases and muscle support decreases. Thus, there is an increase in the activation response and fatigue of the neck superficial muscle group (trapeze, scalene, sternocleidomastoid muscles), and a decrease in neck joint movement and proprioception sense. As a result, it was determined that there are deficiencies in the sense of proprioception in patients with neck pain.
Studies have shown that many receptors related to the sense of position are on deep cervical flexor muscles such as Musculus Longus Capitis and Musculus Longus Colli. In cases where there are changes such as atrophy and fat infiltration in these muscles, there is a decrease in proprioceptive sensation.Conservative treatment is the first choice in the treatment of neck pain. The important components of this treatment are stretching, strengthening, posture, stabilization, proprioception, relaxation, joint movement exercises and aerobic exercises. The purpose of stabilization exercises, which have been used in the treatment of chronic neck pain recently; to support the vertebral column by activating the stabilizing muscles and to improve posture by increasing kinesthetic awareness.
This study will examine the relationship between the sense of cervical proprioception and cervical stabilization exercises in patients with chronic neck pain.
In this study, between 15 June 2022 and 30 January 2023; 72 volunteers, aged between 18-55 years, with neck pain for more than 3 months, with good cognitive function, who applied to the our Physical Medicine and Rehabilitation Clinic will be included. The patients will be randomized to two groups as cervical stabilization exercise group and conventional cervical exercise treatment group. The patients in group 1 will receive cervical stabilization exercises 1 session a day, 3 days a week for 6 weeks, and the patients in group 2 will perform cervical stabilization exercises for 6 weeks, 3 days a week, 1 session a day. conventional cervical exercises will be given. Patients of both groups will do their exercises in the first 3 weeks accompanied by a physiotherapist, and in the last 3 weeks as a home exercise program.
Before the start of the treatment, at the end of the 3rd week and at the end of the 6th week; pain intensity, level of neck disability, quality of life, cervical range of motion and cervical joint position sense will be evaluated and both groups will be compared in these parameters.
Demographic information (address, telephone, age, occupation, height, weight, marital status, etc.) of the patients to be included in the study will be recorded and general musculoskeletal examinations will be performed. The patients will be compared to evaluate for Visual Analogue Scale (VAS), Neck Disability Index (NDI) and Short Form-36 (SF-36), cervical range of motion and cervical joint position sense after intervention. Cervical range of motion and cervical joint position sense will be evaluated with the Cervical Range of Motion Deluxe Device (CROM). conditions: Neck Pain conditions: Chronic Neck Pain studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: Cervical Stabilization Exercise name: Cervical Standard Exercise Group measure: assessment of cervical joint position sense measure: assessment of cervical range of motion measure: assessment of neck disability measure: assessment of pain measure: assessment of life quality sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Zonguldak Bülent Ecevit University city: Zonguldak zip: 67100 country: Turkey lat: 41.45139 lon: 31.79305 hasResults: False
<\|newrecord\|> nctId: NCT06337903 id: Self-compassion for PwMS briefTitle: Self-compassion for People With Multiple Sclerosis: An Exploratory Feasibility Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2025-04-30 date: 2024-03-29 date: 2024-04-01 name: Robert Simpson class: OTHER briefSummary: The goal of this clinical trial is to develop and investigate a compassion-based intervention (Mindful Self-Compassion course) in people with multiple sclerosis. The main objectives are:
1. Explore feasibility of trial processes including recruitment, adherence, retention, and follow-up
2. Explore experiences of people with multiple sclerosis with the Compassion-based intervention, including perceived effects, barriers and facilitators to participation, suggestions for improvement
3. Determine potential effects on stress, anxiety, depression, emotion regulation, illness adjustment, and self-compassion.
Participants will be asked to take part in an 8-week online Mindful Self-Compassion course and report changes in levels of stress, anxiety, depression, self-compassion, adjustment, emotion, and quality of life from pre- to post-intervention and at 3-month follow-up. Additionally, participants will be asked to take part in a semi-structured interview to explore their experiences with the course, perceived effects, and suggestions for improvement. conditions: Multiple Sclerosis conditions: Self-Compassion studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 45 type: ESTIMATED name: Self-compassion intervention (the Mindful Self-Compassion course) measure: Recruitment measure: Retention measure: Adherence measure: Follow-up rates measure: Stress measure: Anxiety measure: Depression measure: Self-compassion measure: Emotion Regulation measure: Quality of Life using the Multiple Sclerosis Impact Scale (MSIS-29) measure: Participant Experiences and Perspectives measure: Adjustment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Unity Health Toronto city: Toronto country: Canada name: Robert Simpson, PhD role: CONTACT lat: 43.70011 lon: -79.4163 hasResults: False
<\|newrecord\|> nctId: NCT06337890 id: FEZECO briefTitle: CO2 Automated Angiographies With Fusion Imaging for Zero- or Near Zero- Contrast FEVAR. overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-29 date: 2024-03-29 name: University of Bologna class: OTHER briefSummary: Fenestrated endovascular aneurysm repair (FEVAR) is an established technique used to treat complex aortic aneurysms (TAAAs), with satisfactory early and midterm results.
Postoperative renal function worsening is a common adverse event after FEVAR of complex aneurysms and is associated with prolonged hospital stay, higher morbidity, and long-term mortality in the peri-operative period and during follow-up. One of the more common causes of renal function worsening is contrast-induced nephropathy resulting from the use of iodinated contrast medium (ICM).
Automated carbon dioxide (CO2) angiography has been proposed as an alternative to ICM for standard endovascular aneurysm repair (EVAR) in consideration of its absence of nephrotoxicity that can be of further help in preserving renal function.
In adjunct, hybrid room and fusion imaging (FI) technologies are useful tools to reduce intraoperative contrast medium and fluoroscopy time.
In literature there are few reports regarding the use of CO2 for fenestrated endografting repair of complex aortic aneurysms.
The aim of the present study is to report the possibility to combine the use of automated CO2 angiographies and Fusion Imaging to obtain zero- or near zero- contrast FEVAR for complex aortic aneurysms. conditions: Aortic Aneurysm studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Zero contrast FEVAR measure: Rate of technical success measure: Reintervention and mortality measure: Number of participants with perioperative renal function worsening measure: Rate of TVVs instability measure: Rate of survival measure: Rate of reintervention measure: Number of participants with renal function worsening sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Bologna status: RECRUITING city: Bologna state: Emilia Romagna zip: 40138 country: Italy name: Enrico Gallitto, MD, PhD role: CONTACT phone: +390512143288 email: enrico.gallitto@gmail.com lat: 44.49381 lon: 11.33875 hasResults: False
<\|newrecord\|> nctId: NCT06337877 id: pEEG ARDS briefTitle: Assessment of Sedation Depth in ARDS Patients Undergoing Therapeutic Paralysis overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-01 date: 2024-04-17 date: 2024-04-24 date: 2024-03-29 date: 2024-03-29 name: Tepecik Training and Research Hospital class: OTHER briefSummary: "In intensive care units, therapeutic paralysis has been a routine treatment method for many years in a select group of patients. Sufficient and appropriate sedation in patients undergoing therapeutic paralysis is crucial to prevent awareness and reduce the risk of excessive sedation. Both inadequate and excessive sedation levels can be highly detrimental to the patient. Clinical assessment may not always provide accurate information regarding sedation depth. Recently, the frequency and workload of therapeutic paralysis treatment in intensive care units have increased due to COVID-19 pneumonia. Therefore, the investigators believe that inadequate sedation may be common in these patients. Processed electroencephalogram parameters such as bispectral index or patient state index (PSI), routinely used in operating rooms and intensive care units, are commonly used to indicate sedation depth. In this study, the investigators aimed to determine sedation levels in patients during paralysis, assess the prevalence of inadequate or excessive sedation, and observe the doses of sedatives and analgesics used." conditions: Sedation Complication conditions: Acute Respiratory Distress Syndrome Due to COVID-19 conditions: Anesthesia Awareness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 52 type: ACTUAL name: Depth of sedation monitoring measure: To determine the sedation levels of patients during paralysis measure: The prevalence of inadequate or excessive sedation, measure: Evaluation of Concordance Between Richmond Agitation-Sedation Scale (RASS), sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aykut Saritaş city: İ̇zmi̇r zip: 35640 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False
<\|newrecord\|> nctId: NCT06337864 id: H-24017055 briefTitle: Evaluating the Efficacy and Safety of Large Neutral Amino Acids in the Treatment of Classical Phenylketonuria overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-12 date: 2027-12 date: 2024-03-29 date: 2024-03-29 name: Rigshospitalet, Denmark class: OTHER briefSummary: This research investigates the effectiveness and safety of large neutral amino acid (LNAA) supplementation in patients with classical phenylketonuria (PKU). Advanced brain imaging techniques alongside comprehensive neuropsychological and functional assessments will be employed. Short-term and long-term follow-up of participants will be conducted. conditions: Brain Diseases conditions: Brain Diseases, Metabolic conditions: Brain Diseases, Metabolic, Inborn conditions: Genetic Diseases, Inborn conditions: Metabolism, Inborn Errors conditions: Amino Acid Metabolism, Inborn Errors conditions: Metabolic Disease conditions: Phenylketonurias studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: To fully assess the effectiveness of LNAA, the following trials will be conducted:
1. A crossover study comparing LNAA supplementation to no treatment
2. A crossover study comparing LNAA supplementation to the Phe-free PKU diet
3. Open-label extension study to assess the long-term safety and efficacy of LNAA supplementation

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