hackint0sh/New-Dataset huggingface dataset:
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
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.
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
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
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.
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
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
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
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
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
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
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 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
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).
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