hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06262477 id: NL-TCZ-12280 briefTitle: A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants overallStatus: RECRUITING date: 2024-01-02 date: 2024-11-30 date: 2024-11-30 date: 2024-02-16 date: 2024-02-16 name: Biogen class: INDUSTRY briefSummary: The primary objective of the study is to show equivalence in pharmacokinetics (PK) of BIIB800 and Actemra following SC administration of a single dose to healthy male participants. The secondary objective of the study is to evaluate PK over time, clinical safety, pharmacodynamic (PD) profiles and immunogenicity of BIIB800 and Actemra. conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: BIIB800 name: Actemra measure: Maximum Serum Concentration (Cmax) of Tocilizumab measure: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tocilizumab measure: Area Under the Concentration-Time Curve up to the Last Measurable Concentration (AUC0-t) of Tocilizumab measure: Time to Reach Cmax (Tmax) of BIIB800 and Tocilizumab measure: Apparent Total Body Clearance (CL/F) of BIIB800 and Tocilizumab measure: Apparent Terminal Half-Life (t1/2) of BIIB800 and Tocilizumab measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Area Under the Effect-Time Curve (AUE) of Soluble Interleukin-6-Receptor (sIL-6R) measure: Maximum Observed Effect (Emax) of sIL-6R measure: Time to Emax (tEmax) of sIL-6R measure: AUE of High Sensitive C-Reactive Protein (hsCRP) measure: Minimum Observed Effect Emin of hsCRP measure: Time to Emin (tEmin) of hsCRP measure: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAbs) measure: Number of Participants With ADA Titers sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Fortrea Clinical Research Unit Inc. status: RECRUITING city: Madison state: Wisconsin zip: 53704 country: United States role: CONTACT phone: 608-210-5574 email: sarah.russell@fortrea.com name: Sarah Russell, MD role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False
nctId: NCT06262464 id: 17.361/ 07.12.2023 briefTitle: An OCD Prevention Programme for at Risk Adults acronym: ØCD overallStatus: RECRUITING date: 2024-02-09 date: 2024-03-29 date: 2024-04-01 date: 2024-02-16 date: 2024-03-18 name: Babes-Bolyai University class: OTHER name: Romanian National Authority for Scientific Research briefSummary: The main purpose of this randomised clinical trial is to test the efficacy of a prevention program for adult who are at risk of developing OCD, thus constituting a form of tertiary prevention. conditions: Obsessive-Compulsive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Prevention measure: Change from baseline in OCD symptoms on the OCI-R after the intervention measure: Change from baseline in depressive symptoms on the PHQ-9 after the intervention measure: Change from baseline in anxiety symptoms on the GAD-7 after the intervention measure: Change from baseline in experiential avoidance on the EAQ after the intervention measure: Change from baseline in cognitive distortions on the OBQ-44 after the intervention measure: Change from baseline in uncertainty intolerance on the IUS after the intervention measure: Change from baseline in resilience on the RSA after the intervention measure: Change from baseline in life quality on the WHOQOL-BREF after the intervention measure: Change from baseline in irrationality on the ATQ after the intervention measure: Change from baseline in global health on the GHQ-12 after the intervention sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Babes-Bolyai University, Faculty of Psychology and Educational Sciences, Department of Clinical Psychology and Psychotherapy status: RECRUITING city: Cluj-Napoca zip: 400015 country: Romania name: Roxana AI Cardos, PhD Student role: CONTACT phone: 0040751477323 email: roxana.cardos@ubbcluj.ro lat: 46.76667 lon: 23.6 hasResults: False
nctId: NCT06262451 id: 20-30182 id: 5R24AI118629 type: NIH link: https://reporter.nih.gov/quickSearch/5R24AI118629 briefTitle: Fecal Microbiota Transplant National Registry overallStatus: RECRUITING date: 2023-10-20 date: 2032-10 date: 2032-10 date: 2024-02-16 date: 2024-02-16 name: University of California, San Francisco class: OTHER name: National Institute of Allergy and Infectious Diseases (NIAID) briefSummary: A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness. Neonates will not be enrolled at any site for this study. The study data will derive from patient and donors past and present medical records, research records, and records about phone calls made as part of this research. The patient data will also be used from the records on visits. conditions: Fecal Microbiota Transplant studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 10 type: ESTIMATED measure: To assess short-term and long-term safety of FMT and other gut-related-microbiota products measure: To characterize effectiveness of FMT and other gut-related-microbiota products. measure: To gather information on FMT practice in North America measure: To promote scientific investigation. measure: To aid practitioners and sponsors in satisfying regulatory requirements sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, San Francisco status: RECRUITING city: San Francisco state: California zip: 94115 country: United States name: Rachael Leigh Delacruz role: CONTACT phone: 415-514-8087 email: rachaelleigh.delacruz@ucsf.edu lat: 37.77493 lon: -122.41942 hasResults: False
nctId: NCT06262438 id: MH22CAQ id: 2022-002886-14 type: EUDRACT_NUMBER id: 2023-505000-27 type: OTHER domain: EU CT Number briefTitle: CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients acronym: CHIP-AML22/Q overallStatus: RECRUITING date: 2024-02-06 date: 2028-06 date: 2032-06 date: 2024-02-16 date: 2024-02-16 name: Princess Maxima Center for Pediatric Oncology class: OTHER name: Daiichi Sankyo briefSummary: The CHIP-AML22 Master protocol has the overall aim of increasing the cure rate in newly diagnosed pediatric de novo AML patients, while avoiding unnecessary toxicity. The linked Quizartinib trial (CHIP-AML22/Quizartinib) is a phase II, single arm, open label, study on the safety, efficacy, pharmacokinetics and pharmacodynamics of quizartinib in combination with chemotherapy and as single-agent after high dose therapy in newly diagnosed pediatric AML patients with a FLT3-ITD mutation and NPM1 wild-type. conditions: Acute Myeloid Leukemia in Children studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Given the rarity of pediatric subjects with newly diagnosed Acute Myeloid Leukemia (AML) with FLT3-ITD mutations and the slow enrollment in historical studies, it is not feasible to enroll a sufficient number of subjects for an adequately powered randomized study. Therefore, a standard oncology Phase 2 response-rate design has been chosen. One of the exploratory objectives planned is to compare the outcome of patients treated in this study to the outcome of patients treated in the NOPHO-DBH AML-2012 study as historical control. primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Quizartinib name: Etoposide name: Dexrazoxane name: Mitoxantrone name: Cytarabine name: Methotrexate name: Daunorubicin name: Fludarabine name: allo-SCT measure: Primary objective (efficacy) measure: Primary objective (safety) measure: Secondary objectives (efficacy_1) measure: Secondary objectives (efficacy_2) measure: Secondary objectives (efficacy_3) measure: Secondary objectives (efficacy_4) measure: Secondary objectives (efficacy_5) measure: Secondary objectives (efficacy_6) measure: Secondary objectives (efficacy_7) measure: Secondary objectives (efficacy_8) measure: Secondary objectives (efficacy_9) measure: Secondary objectives (safety) - Adverse Events, Laboratory Abnormalities and cumulative incidence of non-relapse mortality measure: Pharmacokinetics (PK_1) measure: Pharmacokinetics (PK_2) measure: Pharmacokinetics (PK_3) measure: Pharmacokinetics (PK_4) measure: Palatability of quizartinib formulations sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Princess Máxima Center for pediatric oncology status: RECRUITING city: Utrecht zip: 3584 CS country: Netherlands name: Gertjan Kaspers, Prof. Dr. role: CONTACT name: Bianca Goemans, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 52.09083 lon: 5.12222 hasResults: False
nctId: NCT06262425 id: ALC001NR004 briefTitle: rTMS Over S1 Enhance Motor Learning in Healthy People overallStatus: RECRUITING date: 2024-01-20 date: 2025-06-15 date: 2025-09-15 date: 2024-02-16 date: 2024-02-20 name: Neuron, Spain class: OTHER briefSummary: The purpose of this study is to compare the effectiveness of different repetitive Transcranial Magnetic Stimulation protocols for enhancing motor learning in healthy peolple. conditions: Transcranial Magnetic Stimulation conditions: Motor Learning studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 95 type: ESTIMATED name: repetitive Transcranial Magnetic Stimulation over primary somatosensory cortex name: repetitive Transcranial Magnetic Stimulation over primary motor cortex name: sham repetitive Transcranial Magnetic Stimulation measure: Change in accuracy measure: Change in reaction time speed measure: Change in pegs placed in 30 seconds sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Neuron status: RECRUITING city: Madrid zip: 28045 country: Spain name: Alfredo Lerín Calvo, PhD Student role: CONTACT phone: +34620187457 email: alfre_lerin@hotmail.com lat: 40.4165 lon: -3.70256 hasResults: False
nctId: NCT06262399 id: ITL-2002-CL-999 id: 2022-003778-22 type: EUDRACT_NUMBER briefTitle: Long-Term Follow-Up (LTFU) of Subjects Treated With NTLA 2002 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2040-04 date: 2040-04 date: 2024-02-16 date: 2024-02-16 name: Intellia Therapeutics class: INDUSTRY briefSummary: This is a follow-up study of subjects who received NTLA-2002 in a previous clinical trial as an observational evaluation of the long-term effects of the investigational therapy. conditions: Hereditary Angioedema studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Incidence of treatment-related Adverse Events (AEs); incidence of treatment-related Serious Adverse Events (SAEs); incidence of treatment-related Adverse Events of Special Interest (AESIs) defined per protocol measure: To evaluate the long-term efficacy of NTLA-2002 in previously treated subjects measure: Change from baseline in consumption of on-demand HAE medications for reported HAE attacks measure: Change from baseline in healthcare utilization for HAE attacks measure: Change from baseline in QoL parameters as measured by the MOXIE Angioedema-QoL instrument. measure: Change from baseline in QoL parameters as measured by the EQ-5D-5L instrument. measure: Change from baseline in QoL parameters as measured by the WPAI:GH instrument. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Centre National de Reference - Grenoble city: Grenoble country: France lat: 45.16667 lon: 5.71667 facility: Hôpital Claude Huriez city: Lille country: France lat: 50.63297 lon: 3.05858 facility: New Zealand Clinical Research city: Auckland country: New Zealand lat: -36.84853 lon: 174.76349 facility: Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital city: Cambridge country: United Kingdom lat: 52.2 lon: 0.11667 hasResults: False
nctId: NCT06262386 id: 202202172B0 briefTitle: Combined Relapse Prediction Model for Resectable Non-Small Cell Patients - a Prospective Clinical Feasibility Trial overallStatus: RECRUITING date: 2023-08-01 date: 2028-07-31 date: 2028-07-31 date: 2024-02-16 date: 2024-02-16 name: Chang Gung Memorial Hospital class: OTHER name: National Science and Technology Council briefSummary: For patients with lung cancer who have undergone tumor resection, early relapse significantly impacts survival. However, there are currently no reliable screening or imaging tools available to identify patients at risk of early relapse. To address this clinical challenge, many studies have focused on understanding the clinicopathologic characteristics associated with an increased risk of early relapse. Despite these efforts, we can identify patients at risk but cannot pinpoint which individuals will actually experience early relapse. Studies on adjuvant therapy have shown improved survival in cases of more advanced disease but have not demonstrated a reduction in early relapse rates.
In our preliminary analysis of previous study data, we observed that patients with a smaller reduction in circulating tumor cells (CTCs) within the first three days after surgery, followed by an increase on the third-day post-operation, are more likely to experience early relapse during regular monitoring. This pattern may be indicative of minimal residual disease. By combining trends in circulating tumor cell variations with pathologic characteristics, we aim to select patients for adjuvant therapy who are at high risk of developing early relapse.
The objective of our study is to employ screening based on circulating tumor cell dynamics and pathologic features to identify patients likely to experience early relapse and to assess the effectiveness of adjuvant therapy in these cases. conditions: Lung Cancer conditions: Relapse/Recurrence studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 358 type: ESTIMATED name: Cisplatin based chemottherapy measure: Accuracy of proposed relapse prediction model measure: early relapse rate measure: Overall surveival sex: ALL minimumAge: 20 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ching-Yang Wu status: RECRUITING city: Taoyuan City zip: 333 country: Taiwan name: Ching-Yang Wu role: CONTACT phone: +886975368204 email: wu.chingyang@gmail.com name: Jason CH Hsieh role: CONTACT phone: +886975366137 email: wisdom5000@gmail.com name: Jui-Ying Fu role: SUB_INVESTIGATOR name: Ching-Feng Wu role: SUB_INVESTIGATOR lat: 24.95233 lon: 121.20193 hasResults: False
nctId: NCT06262373 id: 221321 briefTitle: Angular Pregnancy - Ultrasound Definition and Correlation With Clinical Outcomes overallStatus: COMPLETED date: 2017-10-01 date: 2019-10-01 date: 2019-10-01 date: 2024-02-16 date: 2024-02-16 name: King's College Hospital NHS Trust class: OTHER briefSummary: The aim of this study is to establish clinically meaningful ultrasound-based diagnostic criteria for AP. To this end, the investigators will prospectively collect clinical and ultrasound data from early intrauterine pregnancies and correlate this data with pregnancy outcomes (particularly with risk of miscarriage), to establish whether there are any diagnostic criteria that can be used to make the diagnosis, facilitate increased surveillance of at risk pregnancies and reassure those with normally located pregnancies. The collected data will be used to correlate incidence of angular pregnancy and clinical variables such as maternal age, uterine fibroids, assisted conception, multiple pregnancy, ethnicity, previous uterine and adnexal surgery. conditions: Miscarriage in First Trimester studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 236 type: ACTUAL name: Ultrasound measure: Primary measure: Secondary measure: Secondary sex: FEMALE minimumAge: 16 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: King's College Hospital city: London zip: SE5 9RS country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
nctId: NCT06262360 id: P2023457 briefTitle: Changes in Pulmonary Ventilation Distribution Assessed by Electrical Impedance Tomography in Healthy Children Under General Anesthesia acronym: EIT_ped overallStatus: RECRUITING date: 2024-02-16 date: 2024-06-30 date: 2024-09-30 date: 2024-02-16 date: 2024-02-21 name: Queen Fabiola Children's University Hospital class: OTHER briefSummary: The incidence of atelectasis is high in patients undergoing general anesthesia. This may cause oxygenation impairment and further contribute to post-operative pulmonary complications. As important airway management devices for general anesthesia, few studies have compared the impact of laryngeal mask airway and spontaneous breathing on atelectasis. Through the study, the distribution of the pulmonary ventilation of children undergoing an elective and standard procedure in our center (H.U.D.E.R.F.) will be studied using electric impedance tomography.
Induction is based as well on the local routine protocols using an inhalation induction of the patient with Sevoflurane (Fet of 6-8%) and a recommended FiO2 from 80-90% maximum until the stabilization of the induction. Then the FiO2 will be decreased at least under 40% and Sevoflurane adapted to the need of the deepness of the anesthesia (both at the discretion of the anesthesiologist in charge of the patient).
T4: Before the discharge of the PACU. conditions: Anesthesia, Pediatric studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: General anesthesia with mask ventilation name: General anesthesia and spontaneous laryngeal mask ventilation name: General anesthesia with spontaneous laryngeal mask ventilation with pressure support measure: Variation of poorly ventilated pulmonary zones sex: ALL minimumAge: 1 Year maximumAge: 6 Years stdAges: CHILD facility: H.U.B - Hôpital Universitaire des Enfants Reine Fabiola status: RECRUITING city: Brussels zip: 1020 country: Belgium name: Denis Schmartz, MD role: CONTACT phone: +3225553919 email: denis.schmartz@hubruxelles.be lat: 50.85045 lon: 4.34878 hasResults: False
nctId: NCT06262347 id: 2024-0115 id: UG1DA013732 type: NIH link: https://reporter.nih.gov/quickSearch/UG1DA013732 briefTitle: Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for Pregnant and Postpartum Persons in MOUD acronym: TOME overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-20 date: 2025-06-20 date: 2024-02-16 date: 2024-02-20 name: T. John Winhusen, PhD class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) name: National Institute on Drug Abuse (NIDA) briefSummary: The primary objective of this study is to evaluate the ability of TOME to increase Medication for Opioid Use Disorder (MOUD) and opioid-overdose knowledge in pregnant and postpartum persons. conditions: Opioid Use Disorder conditions: Pregnancy Related conditions: Substance Use conditions: Drug Abuse conditions: Drug Abuse in Pregnancy conditions: Drug Addiction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is an intent-to-treat, two-arm, open-label, randomized controlled trial. primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME) name: Control measure: Medication for Opioid Use Disorder (MOUD) knowledge score measure: Opioid Overdose knowledge score measure: Medication for Opioid Use Disorder (MOUD) Internalized Stigma measure: Drug Self-efficacy sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06262334 id: Pro00133917 id: K23MD016123 type: NIH link: https://reporter.nih.gov/quickSearch/K23MD016123 briefTitle: Evaluating the Fade to Fitness Program: A Barbershop-based Program for Black Men overallStatus: RECRUITING date: 2024-03-20 date: 2024-06-15 date: 2024-06-15 date: 2024-02-16 date: 2024-03-26 name: University of South Carolina class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The Fade to Fitness Program is a targeted intervention designed to improve the holistic health and quality of life among Black men. This comprehensive initiative focuses on four key health behaviors: Physical Activity, Healthy Eating, Stress Management, and Depression Management.
The program is structured into weekly sessions that tackle each health behavior, interspersed with off weeks; for community engagement, especially in barbershops, to discuss health topics and promote a healthier lifestyle. conditions: Health Related Quality of Life studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 15 type: ESTIMATED name: The Fade to Fitness Program measure: Number of men who are eligible/eligible. measure: Length of time needed to enroll 15 men measure: Facilitator-assessed attendance in intervention measure: Number of men who express interest in the study measure: Attrition in intervention measure: Acceptability, appropriateness, demand, implementation, practicality, and integration of the intervention measure: Change in weight measure: Change in body mass index measure: Change in moderate-to-vigorous physical activity measure: Global Health - Mental 2a measure: Global Health - Physical 2a measure: Perceived Stress Scale measure: Emotional Distress - Depression - Short Form 4a measure: Healthy Eating Subscale of the Health Promotion Lifestyle Profile II measure: Instrumental Support- Short Form 4a measure: Informational Support - Short Form 4a measure: Emotional Support - Short Form 4a measure: Companionship - Short Form 4a measure: Motivation and Attitudes Towards Changing Health (MATCH) measure: NIH Self-Efficacy Measure measure: Subjective Social Norms of Health Behavior measure: Valuing Questionnaire measure: Diet sex: MALE minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of South Carolina status: RECRUITING city: Columbia state: South Carolina zip: 29208 country: United States name: Guillermo M Wippold, PhD role: CONTACT phone: 803-216-1051 email: wippold@mailbox.sc.edu name: Guillermo M Wippold, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.00071 lon: -81.03481 hasResults: False