hackint0sh/New-Dataset huggingface dataset:
Researchers will compare SOC with protocol-based up-titration to see if the protocolized optimization improves prescription rate of GDMT. conditions: Heart Failure conditions: Heart Failure With Reduced Ejection Fraction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective, randomized-controlled trial. Due to the design, the study is open-label, but the endpoint assessment is blinded. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Due to the study design, the study is open-label. In order to reduce bias, a study nurse (blinded for allocation arm) will see or call the patient to register the heart failure medication and dose of loop diuretics at three months and optionally 12months (open-label, endpoint-blinded). whoMasked: OUTCOMES_ASSESSOR count: 345 type: ESTIMATED name: SOC name: Protocolized up-titration measure: Weighed composite score of maximal guideline-directed medical therapy measure: All-cause mortality and heart failure hospitalizations measure: Change in NTproBNP measure: Change in renal function measure: All-cause mortality measure: Number of patients with heart failure hospitalizations measure: Change in prescription rate per GDMT class measure: Incidence of predefined safety endpoints sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ziekenhuis Oost-Limburg AV city: Genk state: Limburg zip: 3600 country: Belgium lat: 50.965 lon: 5.50082 hasResults: False
nctId: NCT06273267 id: APHP231232 briefTitle: Initiating Pediatric Palliative Care in ACT Group 4 acronym: StartSPP overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-08 date: 2024-08 date: 2024-02-22 date: 2024-02-22 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Due to the wide range of diagnoses encountered in pediatric palliative care, the Association for Children's Palliative Care (ACT) and the Royal College of Paediatrics and Child Health (RCPCH) have developed a classification of life-limiting illnesses, based on support models.
The specific history of ACT-4 patients suggests that pediatric palliative care may be required early on in the history of the disease but effective intervention varies greatly from one patient to another. Tthis study aims to better understand the optimal timing for introducing a PPC team into the care pathway for these children. The study also aims to describe the care trajectory over the first year of PPC intervention. conditions: Encephalopathy conditions: Cerebral Palsy conditions: Cerebral Malformation conditions: Traumatic Head Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED name: Collection of data from the patient's medical file measure: Description of first pediatric palliative care intervention measure: Description of the patient situation measure: Timing of pediatric palliative care intervention sex: ALL maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Hôpital Necker-Enfants Malades city: Paris zip: 75015 country: France name: Ashley RIDLEY, M.D. role: CONTACT phone: 1 42 19 27 28 phoneExt: +33 email: ashley.ridley@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False
nctId: NCT06273254 id: SCVL-TFZ-1009 briefTitle: A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-09 date: 2024-02-22 date: 2024-02-22 name: Viatris Inc. class: INDUSTRY briefSummary: Primary objective is to is to evaluate the bioequivalence of two formulations conditions: Bioequivalence Study studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 48 type: ESTIMATED name: Sacubitril and Valsartan Tablets 49mg/51mg name: Entresto® (Sacubitril and Valsartan Tablets 49mg/51mg) measure: Cmax measure: AUC measure: tmax measure: t1/2 measure: λz measure: AUC0-t/AUC0-∞ measure: residual area sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Medica Innova Co Ltd city: Bangkok zip: 10310 country: Thailand name: Ariya Khunvichai, Ph.D role: CONTACT phone: 666 2428 7178 email: ariya@medicainnova.com name: Suvimol Niyomnaitham, Assist. Prof., M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 13.75398 lon: 100.50144 hasResults: False
nctId: NCT06273241 id: IPHA-2024-009 briefTitle: Impact of Food Intake on Berberine Kinetics acronym: BERKI-3 overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2024-09-30 date: 2024-09-30 date: 2024-02-22 date: 2024-02-22 name: University Medicine Greifswald class: OTHER briefSummary: The influence of genetic variants of the CYP2D6 enzyme and the Organic Cation Transporter 1 on the kinetics of berberine (BERKI-1) has recently been studied. A significant sex difference was observed. These results lead to the BERKI-2 study, investigating the influence of the female hormonal cycle on berberine kinetics. In this study, women took a single berberine dose once in the first and once in the second half of their menstrual cycle, men served as a control group ingesting a single berberine dose. Contrary to our expectations, the previously observed sex difference could not be confirmed.
In both BERKI-1 and 2 studies, the plasma concentration curve exhibited two peaks. The first after about 2-3 h, and the second after approximately 5 h of berberine intake. All participants took a single dose of Berberine under fasting conditions in the morning and 4 h after berberine intake, they ate a meal. Shortly after meal intake, the plasma concentration curve peaked again BERKI-3 will investigate the impact of food intake on berberine bioavailability and the kinetic properties. Given the suspected influence of berberine on glycemic control, we will also measure insulin and glucose after the meal at noon.
24 heathy volunteers with an equal ratio of man and women will be enrolled. conditions: Pharmacokinetic Study in Healthy Volunteers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This is an unblinded, randomized, prospective study comparing berberine intake in fasted condition and after a high or low caloric meal in a cross-over design. primaryPurpose: TREATMENT masking: NONE maskingDescription: This study will be an open label study. Participants will be selected from an existing database of our Institute. count: 24 type: ESTIMATED name: food intake measure: Berberine plasma concentration fasted vs fed measure: Berberine plasma concentrations light vs heavy meal measure: Blood glucose concentrations measure: Blood insulin concentrations sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University Medicine Greifswald, Institute of Pharmacology city: Greifswald state: Mecklenburg-Vorpommern zip: 17487 country: Germany name: Stefan Engeli, Prof. role: CONTACT phone: +49 3834865633 email: stefan.engeli@med.uni-greifswald.de name: Christin Jeschke role: CONTACT phone: +491746471584 email: Christin.Jeschke@med.uni-greifswald.de name: Stefan Engeli, Prof. role: PRINCIPAL_INVESTIGATOR lat: 54.09311 lon: 13.38786 hasResults: False
nctId: NCT06273228 id: STUDY00000788 briefTitle: Parenting Young Children in Pediatrics overallStatus: RECRUITING date: 2023-09-27 date: 2024-10-01 date: 2024-10-01 date: 2024-02-22 date: 2024-02-22 name: University of Oregon class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: Research suggests that one in eight children in the U.S. currently lives with a parent with a substance use disorder. Parents who misuse substances are at increased risk of using harsh and other negative parenting practices with their young children, who are more likely to face challenges with emotional and behavioral regulation and subsequently misuse substances themselves. There is thus an urgent need for evidence-based interventions to promote positive parenting skills in parents who misuse substances. Interventions must be convenient, non-stigmatizing, and accessible to parents with problematic substance use, who frequently face barriers to engaging with healthcare systems. Pediatric primary care is an ideal setting to offer a brief intervention for maladaptive parenting behaviors associated with parental substance use, as the vast majority of children under 5 access pediatric primary care at least annually and parents generally report high levels of trust in their child's pediatrician.
The Family Check-Up (FCU) Online app, which was created specifically to promote positive parenting skills in parents with past or current substance misuse, is ideal for delivery to parents with pre-school age children in a pediatric primary care setting as it is brief, convenient, and delivered in a self-directed format that parents favor. The main objective of this pilot study is to test the feasibility and acceptability of the FCU-Online, a brief, app-based parenting intervention, for parents reporting lifetime problematic substance use in a pediatric primary care setting.
In this study, investigators will partner with pediatric primary care providers to recruit parent participants, then evaluate feasibility and acceptability by systematically assessing parents' engagement with the FCU Online app. Engagement data from the app includes time spent in app overall and in each module, activities completed, and which modules were accessed. Investigators will also administer a consumer satisfaction survey, which will ask parents to report on their perceptions of the app (e.g., helpfulness, useability, and effects on parenting). To assess engagement in telehealth coaching sessions, investigators will use the following variables: number of telehealth sessions completed, length of session, content of sessions, and coaches' ratings of participant engagement in the session and barriers to using the app. Coaches will also rate participant engagement on a 3-point scale from "low" to "high." Lastly, investigators will conduct qualitative interviews with a sub-sample of participants to solicit additional feedback on the acceptability of the FCU Online, focusing particularly on the perception of acceptability within an integrated primary care context and stigma associated with endorsing substance use in this setting.
A second aim of this study is to assess pediatric healthcare providers' perceptions and attitudes regarding the fit of the FCU Online with their practice settings as well as potential barriers to implementation. Through semi-structured focus groups and qualitative interviews with pediatric healthcare providers, investigators will assess provider- and practice-level factors that may facilitate or impede the implementation of the FCU Online in pediatric primary care settings. conditions: Parenting conditions: Parent-Child Relations conditions: Substance Use Disorders conditions: Stress conditions: Depression conditions: Anxiety conditions: Parenting Self-efficacy conditions: Pediatrics studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Parents will be recruited in pediatric primary care settings and will be assessed at baseline and at a 3-month follow-up. Parents will receive the intervention between baseline and follow-up. Nine parents will be randomly selected for an additional follow-up interview. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 36 type: ESTIMATED name: Family Check-Up Online measure: change from baseline in parenting skills measure: change from baseline in parenting efficacy measure: change from baseline in parent executive functioning measure: change from baseline in child social-emotional behavior measure: change from baseline in family conflict measure: change from baseline in parental substance use measure: change from baseline in parental depression measure: change from baseline in parental anxiety measure: change from baseline in parental stress measure: change from baseline in parental impact of negative life events sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Prevention Science Institute, University of Oregon status: RECRUITING city: Eugene state: Oregon zip: 97403 country: United States name: Katherine Hails, PhD role: CONTACT phone: 610-457-8627 email: khails@uoregon.edu name: Elizabeth Stormshak, PhD role: CONTACT phone: 541-912-3792 email: bstorm@uoregon.edu name: Katherine Hails, PhD role: PRINCIPAL_INVESTIGATOR lat: 44.05207 lon: -123.08675 hasResults: False
nctId: NCT06273215 id: DCTC-IIR202217 briefTitle: Evaluation of the Pharmacokinetics of Microdose Midazolam, Dabigatran, Pitavastatin, Atorvastatin and Rosuvastatin in Diabetic Patients overallStatus: RECRUITING date: 2023-03-05 date: 2025-12-31 date: 2025-12-31 date: 2024-02-22 date: 2024-02-22 name: Peking University Third Hospital class: OTHER briefSummary: 1.To explore the functional changes of P-gp, CYP3A4, OATP1B and BCRP in Diabetic patients (including the non-obese T2DM, obese T2DM, elderly T2DM, and T1DM). conditions: Diabetes studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 48 type: ESTIMATED name: The combinations of 10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin were administered to diabetic patients on an empty stomach. measure: Pharmacokinetics of study drug measure: Concentration of endogenous markers of CYP3A and OATP measure: Genotype of OATP and BCRP sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Yafen Li role: CONTACT phone: 18222566785 email: liyafen314159@163.com name: Dongyang Liu role: PRINCIPAL_INVESTIGATOR name: Tianpei Hong role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
nctId: NCT06273202 id: 6257 briefTitle: Ultrasound Monitoring of Muscle Thickness in Premature Patients acronym: NeoMassage overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-07 date: 2025-01 date: 2024-02-22 date: 2024-02-22 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The goal of this interventional study is to investigate through musculoskeletal ultrasonography how the thickness and muscle trophism in infants aged 28 to 35 weeks undergoing infant massage compared with a group of infants with similar characteristics not subjected to treatment.
Ultrasound will be performed at the time of randomization (T0) and then 1 time per week until the 35th week by two operators (SN and VA); at the same time, the circumference of the thigh subjected to ultrasound examination. A 12Hz linear ultrasound probe will be used, applied perpendicular to the skin. The infant will be placed supine, with the thigh extended, in a neutral position; excessive compression will be avoided by applying a generous amount of gel. At the midpoint of the thigh, the thickness of the quadriceps muscle will be calculated by measuring the distance between the cortex of the femur and the most superficial muscle fascia. The average of at least 2 measurements will be then calculated. The Heckmatt scale will be used to assess the echogenicity of muscle and bone. In addition, at time T0 and at week 35 the following data will be collected: weeks gestational age, weight at birth and at the end of treatment, rectal temperature, blood gas parameters if present. conditions: Prematurity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 24 type: ESTIMATED name: Infant Massage measure: Quadriceps femuri thickness measure: Quadriceps femuri trophism measure: To valuate the discomfort/behavioral status of the infant. measure: To valuate the potential effects on spontaneous motility. measure: To evaluate differences in ponderal growth. sex: ALL minimumAge: 28 Weeks maximumAge: 35 Weeks stdAges: CHILD hasResults: False
nctId: NCT06273189 id: 2017/558 briefTitle: Ultrasonic Bone Scalpel in BSSO overallStatus: COMPLETED date: 2018-12-15 date: 2020-12-15 date: 2021-12-15 date: 2024-02-22 date: 2024-02-22 name: TC Erciyes University class: OTHER briefSummary: The conventional saw compared with the piezo surgery in BSSO to evaluate cutting time, surgery duration, amount of bleeding. The purpose of this study was to answers following clinical questions: Is ultrasonic bonescalpel effective osteotomy like conventional bur in BSSO? and 2) Does it reduce operative parameter like bleeding, duration, lingual split pattern? 3) Does it reduce postoperative morbidity after BSSO. conditions: Maxillofacial Abnormalities studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: double blind primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Conventional name: Bone Scalpel measure: Cutting Time measure: neurosensory disturbance measure: The length of the procedure measure: The splitting time measure: The pattern of the split measure: postoperative edema sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Selin Çelebi city: Kayseri state: Melikgazi zip: 38039 country: Turkey lat: 38.73222 lon: 35.48528 hasResults: False
nctId: NCT06273176 id: MEC-2020-0812 briefTitle: The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma acronym: RECMAP overallStatus: RECRUITING date: 2023-01-01 date: 2027-01-01 date: 2028-01-01 date: 2024-02-22 date: 2024-02-22 name: Erasmus Medical Center class: OTHER name: Haaglanden Medical Centre name: Universitaire Ziekenhuizen KU Leuven name: University Hospital Heidelberg name: Technical University of Munich name: Insel Gruppe AG, University Hospital Bern name: Massachusetts General Hospital name: University of California, San Francisco briefSummary: Resection of glioblastoma in or near functional brain tissue is challenging because of the proximity of important structures to the tumor site. To pursue maximal resection in a safe manner, mapping methods have been developed to test for motor and language function during the operation. Previous evidence suggests that these techniques are beneficial for maximum safe resection in newly diagnosed grade 2-4 astrocytoma, grade 2-3 oligodendroglioma, and recently, glioblastoma. However, their effects in recurrent glioblastoma are still poorly understood. The aim of this study, therefore, is to compare the effects of awake mapping and asleep mapping with no mapping in resections for recurrent glioblastoma.
This study is an international, multicenter, prospective 3-arm cohort study of observational nature. Recurrent glioblastoma patients will be operated with mapping or no mapping techniques with a 1:1 ratio. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months after surgery and 2) residual tumor volume of the contrast-enhancing and non-contrast-enhancing part as assessed by a neuroradiologist on postoperative contrast MRI scans. Secondary endpoints are: 1) overall survival (OS), 2) progression-free survival (PFS), 4) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.
The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM). conditions: Glioblastoma, IDH-wildtype conditions: Glioblastoma conditions: Glioblastoma Multiforme of Brain conditions: Astrocytoma, Malignant conditions: Brain Neoplasms conditions: Brain Neoplasms, Adult, Malignant conditions: Brain Neoplasms, Adult conditions: Recurrent Adult Brain Tumor conditions: Recurrent Glioblastoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 225 type: ESTIMATED name: Awake mapping under local anesthesia name: Asleep mapping under general anesthesia name: Resection under general anesthesia without mapping measure: Residual volume measure: Neurological morbidity at 6 weeks measure: Overall survival measure: Progression-free survival measure: Onco-functional outcome (OFO) measure: Serious Adverse Events measure: Neurological morbidity at 3 months measure: Neurological morbidity at 6 months measure: Overall functioning at 6 weeks measure: Overall functioning at 3 months measure: Overall functioning at 6 months measure: Quality of life at 6 weeks (EORTC QLQ C30) measure: Quality of life at 3 months (EORTC QLQ C30) measure: Quality of life at 6 months (EORTC QLQ C30) measure: Quality of life at 6 weeks (EORTC QLQ BN20) measure: Quality of life at 3 months (EORTC QLQ BN20) measure: Quality of life at 6 months (EORTC QLQ BN20) measure: Quality of life at 6 weeks (EQ-5D) measure: Quality of life at 3 months (EQ-5D) measure: Quality of life at 6 months (EQ-5D) sex: ALL maximumAge: 90 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, San Francisco status: RECRUITING city: San Francisco state: California zip: 94143 country: United States name: Mitchel Berger, MD PhD role: CONTACT lat: 37.77493 lon: -122.41942 facility: Massachusetts General Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Brian Nahed, MD PhD role: CONTACT lat: 42.35843 lon: -71.05977 facility: University Hospital Leuven status: RECRUITING city: Leuven country: Belgium name: Steven De Vleeschouwer, MD PhD role: CONTACT lat: 50.87959 lon: 4.70093 facility: Universitätsklinikum Heidelberg status: RECRUITING city: Heidelberg country: Germany name: Christine Jungk, MD PhD role: CONTACT name: Sandro Krieg, MD PhD role: CONTACT lat: 49.40768 lon: 8.69079 facility: Technical University Munich status: NOT_YET_RECRUITING city: Munich country: Germany name: Arthur Wagner, MD role: CONTACT lat: 48.13743 lon: 11.57549 facility: Erasmus Medical Center status: RECRUITING city: Rotterdam state: Zuid-Holland zip: 3015 GD country: Netherlands name: Jasper Gerritsen, MD PhD role: CONTACT lat: 51.9225 lon: 4.47917 facility: Haaglanden Medical Center status: RECRUITING city: The Hague country: Netherlands name: Marike Broekman, MD PhD role: CONTACT lat: 52.07667 lon: 4.29861 facility: Inselspital Universitätsspital Bern status: NOT_YET_RECRUITING city: Bern country: Switzerland name: Philippe Schucht, MD PhD role: CONTACT lat: 46.94809 lon: 7.44744 hasResults: False