hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06312423 id: ECDA000/02 briefTitle: Safety and Pharmacokinetics of IMT504, an Immunomodulator and Tissue Repair Inducer acronym: ECDA000/02 overallStatus: RECRUITING date: 2024-02-23 date: 2024-08-30 date: 2024-12-30 date: 2024-03-15 date: 2024-03-15 name: Ministry of Public Health of the Province of La Rioja class: OTHER_GOV name: Immunalgia Therapeutics S.A. briefSummary: Phase 1 open-label dose-escalation study to evaluate the safety and pharmacokinetics of IMT504 Phosphorothioate Oligonucleotide, an immunomodulator and tissue repair inducer, in healthy volunteers. conditions: Immune System studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: A total of 12 healthy adult volunteers of both sexes will be included, who will be progressively incorporated into 3 groups of 4 volunteers each. All volunteers will be evaluated at a research site authorized by the Regulatory Authority (ANMAT) to conduct phase 1 studies. primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Oligonucleotides, Phosphorothioate measure: Safety: Local and systemic reaction after administration of each dose of the investigational drug measure: Safety: Serious adverse event measure: Safety: Variations in the Laboratory results measure: Pharmacokinetics: IMT504 level in Serum measure: Pharmacokinetics: IMT504 level in Serum measure: Pharmacokinetics: IMT504 level in Serum measure: Pharmacokinetics: IMT504 level in Serum measure: Pharmacokinetics: IMT504 level in Serum measure: Pharmacodynamics: Interleukin - 35 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CENTRO DE INVESTIGACIÓN PARA ESTUDIOS DE FARMACOLOGÍA CLÍNICA DE FASE1 EN POBLACIÓN ADULTA y DE BIOEQUIVALENCIA. Sanatorio Nuestra Señora del Pilar status: RECRUITING city: Buenos Aires zip: 1702 country: Argentina name: Eduardo Pirotzky, Doctor role: CONTACT phone: 541144696700 email: epirotzky@yahoo.com lat: -34.61315 lon: -58.37723 hasResults: False
nctId: NCT06312410 id: H-23067714 briefTitle: The VIA Family 2.0 - a Family Based Intervention for Families With Parental Mental Illness overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2027-12-31 date: 2028-12-31 date: 2024-03-15 date: 2024-03-15 name: Mental Health Services in the Capital Region, Denmark class: OTHER name: Aalborg Psychiatric Hospital name: TrygFonden, Denmark name: Novo Nordisk A/S name: Lundbeck Foundation name: Liljeborgfonden name: Ebbefos Fonden name: KV Fonden briefSummary: VIA Family 2.0 - a Family Based Intervention for families with parental mental illness
Method: A large randomized, controlled trial (RCT) for families with parental mental illness will be conducted in order to evaluate the effect of a two-year multidisciplinary, holistic team intervention (the VIA Family 2.0 team intervention) against treatment as usual (TAU). Inclusion criteria will be biological children 0-17 of parents with any mental disorder treated in the secondary sector at any time of their life and receiving treatment in primary or secondary sector within the previous three years. A total of 870 children or approx. 600 families will be included from two sites. Primary outcomes will be changes in child well being, parental stress, family functioning and quality of the home environment, .
Time plan: The RCT will start including families from March 1st, 2024 to Dec 2025 (or later if needed). All families will be assessed at baseline and at end of treatment, i.e. after 24 months and after 36 months. Baseline data will inform the intervention team about each family's needs, problems, and motivation. TAU will be similar in the two regions, which means three family meetings and option for children to participate in peer groups.
Challenges: final funding is being applied for. Recruitment of families can be challenging but we have decades of experience in conducting research in the field. Since both the target group, their potential problems and the intervention is complex, primary outcome is difficult to determine. conditions: Child conditions: Parents conditions: Mental Disorder conditions: Child of Impaired Parents conditions: Preventive Health Services studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1452 type: ESTIMATED name: VIA Family 2.0 measure: Change in Strengths and Difficulties Questionnaire (SDQ) measure: Change in Bayley-4 Bayley Scales Test for Infant and Toddler Development measure: Change in Family Assessment Device - General Function Scale (FAD-GF) measure: Change in Parental Stress Scale (PSS) measure: Change in Home Observation for Measurement of the Environment (HOME) measure: Change in Parenting and Family Adjustment Scales (PAFAS) measure: Change in Children's Global Assessment Scale (CGAS) measure: Change in Perceived Stress Scale (PSS) measure: Client Satisfaction Scale (CSQ) measure: Change in Vineland Adaptive Behavior Scales-Second Edition (Vineland-II) measure: Change in children's quality of life (KIDSCREEN-27) measure: Change in Ages and Stages Questionnaire:SE-2 (ASQ-SE) measure: Change in Daily Life Stressor Scale (DLSS) measure: Change in Child and Youth Resilience Measure (CYRM-R) measure: Alarm Distress Baby Scale (ADBB) measure: Change in Personal and Social Performance Scale (PSP) measure: Change in Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) measure: Change in Global Assessment of Function - Symptoms (GAF-S) measure: Change in Kessler Psychological Distress Scale, K10 measure: Change in General Self-Efficacy Scale (GSE) measure: Change in Social Provision Scale-short form (SPS) measure: Change in Quality-adjusted life year (EQ-5D) measure: Change in Self-Stigma of Mental Illness Scale - short form (SSMIS-SF) measure: Change in The Questionnaire about the Process of Recovery (QPR) sex: ALL minimumAge: 0 Years maximumAge: 17 Years stdAges: CHILD hasResults: False
nctId: NCT06312397 id: MU-HF-BVD-01 briefTitle: The Effect on Back Pain and Fatigue Level of Acupressure overallStatus: RECRUITING date: 2024-03-04 date: 2024-07-30 date: 2024-08-30 date: 2024-03-15 date: 2024-03-15 name: Mersin University class: OTHER briefSummary: This research was conducted with the aim of determining the effect of acupressure on the level of back pain and fatigue after coronary angiography. conditions: Coronary Angiography studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Three groups ( acupressure group, sham acupressure group and control group) primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Patients in the acupressure and sham acupressure groups were blinded as to which groups they were in. whoMasked: PARTICIPANT count: 120 type: ESTIMATED name: Acupressure name: Sham acupressure measure: Visual Analog Scale for Pain measure: Visual Analog Scale for Fatigue sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Birgül VURAL DOĞRU status: RECRUITING city: Mersin zip: 33110 country: Turkey name: Birgül VURAL DOĞRU, Associate Professor role: CONTACT phone: 03243610001 email: bvuraldogru@gmail.com lat: 36.79526 lon: 34.61792 hasResults: False
nctId: NCT06312384 id: A04080622 briefTitle: The Influence of 3D Surgical Template on the Contour of Bone Augmentation, in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation overallStatus: ACTIVE_NOT_RECRUITING date: 2022-07-01 date: 2024-05 date: 2024-06 date: 2024-03-15 date: 2024-03-15 name: Mansoura University class: OTHER briefSummary: Evaluate the impact of using 3D surgical template with guided bone regeneration technique on the contour of bone augmentation in patients with horizontal labial ridge defect and simultaneous implantation. conditions: Bone Deformity studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group 1 \[Control group\]:
The defected site will be grafted with sticky bone (particulate bone substitute mixed with injectable platelet-rich fibrin (i-PRF)) and will be covered with collagen membrane will be applied, in this group 3D surgical template will be applied. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: each patient will be couded and only the princeiple investigator is the only person how know the type of intervantion whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: 3D Surgical Template on the Contour of Bone Augmentation, in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation name: conventional guided bone regeneration,in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation measure: Change in Radiographic assessment for all patients underwent Cone beam computed tomography (CBCT) scans sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Dentistry-Mansoura University city: Mansoura zip: 35516 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False
nctId: NCT06312371 id: Feeding Hesitancy briefTitle: Intermittent Oro-esophageal Tube on Feeding Hesitancy in Stroke Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-15 date: 2024-03-15 name: Muhammad class: OTHER briefSummary: The aim of this clinical trial is to compare Feeding Hesitancy of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Feeding Hesitancy of the two groups. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding measure: Swallowing Quality of Life questionnaire sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06312358 id: IRB00408654 briefTitle: Expanding the Infant Achievements Intervention Through Community Partnerships overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06-30 date: 2024-07 date: 2024-03-15 date: 2024-03-15 name: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. class: OTHER name: Johns Hopkins University briefSummary: The goal of the research study is to increase teachers' implementation of evidence-based practices in Early Head Start classrooms through the delivery of a professional development (PD) training intervention. The main questions that the study aims to answer are:
Participants will attend PD workshops and participate in content-related job-embedded coaching sessions during the implementation of the study. conditions: Child Development conditions: Infant Development conditions: Developmental Delay conditions: Language Development studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All participants will be assigned to the study intervention consisting of (1) a professional development workshop and (2) weekly job-embedded coaching sessions. primaryPurpose: PREVENTION masking: NONE count: 15 type: ESTIMATED name: Building Capacity for Infant Achievements in Child Care measure: Classroom Quality (as assessed by scores on the TPITOS) sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06312345 id: 2024.3.10-2024.5.1 briefTitle: Ciprofol Versus Propofol for Anesthesia Induction in Cardiac Surgery: A Randomized Double-blind Controlled Clinical Trial overallStatus: RECRUITING date: 2024-03-11 date: 2024-05-01 date: 2024-05-10 date: 2024-03-15 date: 2024-03-15 name: Le Yu class: OTHER briefSummary: Ciprofol, a novel intravenous general anesthetic with a chemical structure akin to propofol, boasts significantly enhanced potency. It offers a rapid onset, reduced incidence of injection pain, and minor impact on the cardiovascular system. However, clinical research regarding ciprofol's use for anesthesia induction in cardiac surgery remains limited. conditions: Anesthesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Drug: ciprofol injection measure: Mean arterial pressure measure: Mean arterial pressure measure: Mean arterial pressure measure: Mean arterial pressure measure: Heart beats measure: Heart beats measure: Heart beats measure: Heart beats measure: Oxygenation index measure: Oxygenation index measure: Injection pain sex: ALL minimumAge: 55 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai East Hospital of Tongji University status: RECRUITING city: Shanghai state: Shanghai zip: 200120 country: China name: Le Yu, MM role: CONTACT phone: 19921875120 email: 907084943@qq.com lat: 31.22222 lon: 121.45806 hasResults: False
nctId: NCT06312332 id: HUM00220089 id: 1R01HL163438-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R01HL163438-01A1 briefTitle: Michigan Emergency Department Improvement Collaborative (MEDIC) Alert; Pulmonary Embolism (PE) overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-01 date: 2026-08 date: 2026-08 date: 2024-03-15 date: 2024-04-26 name: University of Michigan class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: This study is a quality improvement project to evaluate health care management of pulmonary embolism (PE) patients. The researchers are testing an intervention to determine if it prevents unnecessary hospital admissions. conditions: Pulmonary Embolism studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: cluster-randomized stepped-wedge design with two or more sites assigned at each of four steps primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 14 type: ESTIMATED name: Pulmonary Embolism (PE) Care in Emergency Department (ED) measure: Change in proportion of patients discharged home from Emergency Department (ED) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Michigan Emergency Department Improvement Collaborative partners city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 hasResults: False
nctId: NCT06312319 id: DF0001 briefTitle: Home-based Respiratory Training on Swallowing in Stroke overallStatus: RECRUITING date: 2023-08-20 date: 2024-03-20 date: 2024-06-20 date: 2024-03-15 date: 2024-03-18 name: Universidad de Granada class: OTHER briefSummary: The aim of this study is to evaluate the effects of a home-based respiratory muscle training on swallowing function in patients with chronic stroke. The patients will be included in a experimental or a control group. The patients in the experimental group will receive a home-based respiratory training using respiratory devices added to standard treatment, while the participants in the control group will only receive the standard treatment. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Respiratory training name: Orofacial exercises measure: Gugging Swallowing screen measure: Swallowing quality of life questionnaire measure: cough peak flow measure: Forced vital capacity measure: Forced expiratory volumen in the first second measure: FEV1/FVC ratio measure: Respiratory Pressure Meter sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Health Sciences status: RECRUITING city: Granada zip: 18016 country: Spain name: Irene Cabrera Martos role: CONTACT email: irenecm@ugr.es lat: 37.18817 lon: -3.60667 hasResults: False
nctId: NCT06312306 id: TDCS vs pilates in stroke briefTitle: Transcranial Direct Current Stimulation vs Pilates Core Training in Stroke overallStatus: RECRUITING date: 2024-02-25 date: 2024-08 date: 2024-09 date: 2024-03-15 date: 2024-03-26 name: Cairo University class: OTHER briefSummary: The goal of this clinical trial is to compare the effects of transcranial direct current stimulation and pilates based core stability training on gait and balance in stroke patients. The main question\[s\] it aims to answer are:
Researchers will compare the transcranial direct current stimulation group with the pilates exercise group to see if one of them is superior to the other on balance and gait. conditions: Stroke conditions: Cerebrovascular Accident studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: transcranial direct current stimulation name: Pilates based core training name: conventional physiotherapy program measure: Gait kinematics measure: The Biodex Balance System measure: Stroke Impact Scale (SIS) sex: ALL minimumAge: 50 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of physical therpay cairo university status: RECRUITING city: Dokki state: Giza zip: 12613 country: Egypt name: Amal Abdel-Baky, Professor role: CONTACT phone: +202 37617691 email: p.grad@pt.cu.edu.eg lat: 30.03823 lon: 31.2113 hasResults: False
nctId: NCT06312293 id: STUDYAP0004 briefTitle: Comparison of Effectiveness In-ear and Behind-ear Vagus Nerve Stimulation overallStatus: COMPLETED date: 2023-09-15 date: 2023-12-01 date: 2023-12-30 date: 2024-03-15 date: 2024-03-15 name: Bahçeşehir University class: OTHER briefSummary: The use of vagus nerve stimulation (VSS), one of the examples of neuromodulation therapies, continues to increase in the medical field. Basically, invasive (iVSS) and transcutaneous VSS (tVSS) can be performed. tVSS is more preferred because of its advantages such as easy application, not requiring surgical procedure and having fewer side effects. VSS has long been an approved treatment modality in the treatment of epilepsy and refractory depression. tVSS can be administered from the auricular-auricular or posterior ear region. The vagus nerve (VS) belongs to the parasympathetic branch of the autonomic nervous system and has an effect on vital functions. There are also studies in the literature showing that VS stimulation reduces inflammation. In addition to this effect, the vagus nerve may also show analgesic activity through pain-related pathways. Due to its anti-inflammatory and analgesic effects, VSS has become a new treatment method in diseases in which various inflammatory processes are shown in the etiology such as inflammatory bowel diseases, musculoskeletal system diseases and central nervous system diseases. conditions: Vagus Nerve Stimulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 76 type: ACTUAL name: Transcutaneous Vagus Nerve Stimulation measure: Heart Rate Variability sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Igdir University city: Igdir state: Central zip: 76000 country: Turkey lat: 39.92371 lon: 44.045 hasResults: False
nctId: NCT06312280 id: CE342/2023 briefTitle: Evaluation of Body Composition in Pediatric Patients With Overweight or Obesity acronym: OBIASITY overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-01 date: 2024-11-30 date: 2024-03-15 date: 2024-03-19 name: Azienda Ospedaliero Universitaria Maggiore della Carita class: OTHER briefSummary: In recent decades, the prevalence of obesity and overweight has dramatically increased globally, representing a serious problem for society and for the health system of many countries, estimating an impact of 2-8% on global health spending. Obesity and overweight represent a problem not only for adults but also for children and adolescents: the latest data from the WHO estimate that about 340 million children and adolescents between 5 and 19 years are overweight or obese, data that increase drastically since 1975 from 4% of boys to 18% in 2016. (World Health Organization (WHO). The reduction and prevention of overweight and obesity in childhood is one of the main missions of public health at the global level, both for short-term and long-term implications. Recently, the importance of bioprothesiometric analysis (BIA) in the clinical routine has been evaluated, as it allows an estimation of body composition that would not otherwise be provided by the growth curves and the calculation of the Body Mass Index (BMI). In this study the investigators want to evaluate, in addition to the classic clinical parameters, the body composition of patients evaluated by means of an impedance balance (named TANITA MC780 MA P). With this study the investigators aim to investigate possible clinical and body composition changes in children and adolescents suffering from overweight and obesity with the ultimate aim of reducing cardio-metabolic risk factors related to it.
The secondary objective is to assess the dietary compliance of the patients being studied and the possible correlation with the body composition. conditions: Pediatric Obesity studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 70 type: ESTIMATED name: Mediterranean diet measure: Change in Body composition measure: Dietary compliance with questionnaires measure: Correlation between change in body composition (primary outcome) and dietary compliance (secondary outcome) sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: SCDU Pediatria, AOU Maggiore della Carità city: Novara zip: 28100 country: Italy name: Simonetta Bellone, MD role: CONTACT phone: +39-0321-660693 email: simonetta.bellone@med.uniupo.it lat: 45.44694 lon: 8.62118 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-10-23 uploadDate: 2024-03-13T05:14 filename: Prot_SAP_000.pdf size: 348071 hasResults: False
nctId: NCT06312267 id: 1840655 briefTitle: Reducing Wound Infections Using Bioelectric Wound Dressings acronym: JumpStart overallStatus: RECRUITING date: 2024-03-04 date: 2024-12-01 date: 2025-03-01 date: 2024-03-15 date: 2024-03-15 name: AdventHealth class: OTHER briefSummary: The purpose of this study is to compare the outcomes of using Bioelectric wound dressing on the pre-operative wound site and post operatively and compared it outcomes to the standard of care chlorhexidine skin preparation. conditions: Surgical Site Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Total of 20 patients will be identified and divided in two groups (control and experimental group). 10 of the patients undergo surgery using current ERAS protocol standard of care skin cleaning preparation. The other 10 patients skin prep will be substituted with the Bioelectrical dressing preoperatively and post-operative. primaryPurpose: PREVENTION masking: NONE count: 20 type: ESTIMATED name: Bioelectric dressing measure: Quantitative bacterial count sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AdventHealth Celebration status: RECRUITING city: Kissimmee state: Florida zip: 34747 country: United States name: Petronio Martins, MHA role: CONTACT phone: 321-299-6655 email: Petronio.martins@AdventHealth.com name: Diana Paredes, BSN role: CONTACT phone: 407-535-1984 email: Diana.Paredes@AdventHealth.com lat: 28.30468 lon: -81.41667 hasResults: False