hackint0sh/New-Dataset huggingface dataset:
H3: There is a difference between the stress levels of parents before the application of infant diaper care in preterm infants. conditions: Preterm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 105 type: ESTIMATED name: No parental participation name: Mother participation name: Father participation measure: Level of Parental Stress measure: Change in Level of Comfort sex: ALL minimumAge: 1 Day maximumAge: 28 Days stdAges: CHILD facility: Acıbadem University status: RECRUITING city: İstanbul state: Ataşehir zip: 34750 country: Turkey name: Tuğba Türker, Nurse role: CONTACT email: tugba.turker@live.acibadem.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False
nctId: NCT06345729 id: 1084-004 id: MK-1084-004 type: OTHER domain: Merck id: U1111-1296-8093 type: OTHER domain: UTN id: 2023-507776-42 type: REGISTRY domain: EU CT briefTitle: A Study of MK-1084 Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant, Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004) overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2029-02-19 date: 2031-02-18 date: 2024-04-03 date: 2024-04-09 name: Merck Sharp & Dohme LLC class: INDUSTRY briefSummary: This is a study evaluating the efficacy and safety of MK-1084 with pembrolizumab as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There are two primary study hypotheses:
Hypothesis 2: Combination of MK-1084 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS). conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: MK-1084 name: Placebo name: Pembrolizumab measure: Progression-Free Survival (PFS) measure: Overall Survival (OS) measure: Objective Response Rate (ORR) measure: Duration of Response (DOR) measure: Number of Participants Who Experience One or More Adverse Event (AEs) measure: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) Chest pain (Item 40) Score measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Chest pain (Item 40) Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06345716 id: renal colic 2024 briefTitle: Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic acronym: RC overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2025-03-15 date: 2025-11-30 date: 2024-04-03 date: 2024-04-03 name: University of Monastir class: OTHER briefSummary: This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group. conditions: Renal Colic studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 1500 type: ESTIMATED name: paracétamol tramadol name: Paracétamol cafeine name: Placebo measure: Pain recurrence measure: Painful recurrence measure: number of patient who revist the ED for residual pain measure: Adverse effects sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06345703 id: NeuShen Therapeutics briefTitle: First-into-human Study of NS-136 in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-11 date: 2025-02 date: 2024-04-03 date: 2024-04-03 name: NeuShen Therapeutics class: INDUSTRY briefSummary: The goal of this clinical trial is to exlplore the profile of NS-136 in health conditions. The main questions it aims to answer are:
* What is the pharmacokinectic profile of NS-136 in healthy subjects under tested dosing regimen? conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The trial consists of three parts: the first part is a single ascending dose (SAD) study, the second part is a multiple ascending dose (MAD) study, and the third part is food effect (FE) study. The first two parts (SAD and MAD) will be randomized, double-blind, single or multiple ascending dose and placebo-controlled study designs. The third part (FE) will be a randomized, open-label, two-period, crossover study design. To evaluate the safety, tolerability, pharmacokinetic profile, and the effect of food on the PK profile of NS-136 in healthy subjects and to determine the maximum tolerated dose (MTD) primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Placebo name: NS-136 tablet measure: Number of Participants with Treatment-Related Adverse Events measure: Main pharmacokinetic parameters measure: Main pharmacokinetic parameters measure: Main pharmacokinetic parameters measure: Main pharmacokinetic parameters measure: Main pharmacokinetic parameters measure: Main pharmacokinetic parameters sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CMAX Clinical Research Pty Ltd city: Adelaide state: South Australia zip: 5000 country: Australia name: Study Services Director role: CONTACT phone: +61 08 7088 7900 email: cmax@cmax.com.au lat: -34.92866 lon: 138.59863 hasResults: False
nctId: NCT06345690 id: VIA-2023-003 briefTitle: VIA Disc NP Registry 3.0 overallStatus: RECRUITING date: 2024-02-27 date: 2027-01-01 date: 2027-01-01 date: 2024-04-03 date: 2024-04-03 name: VIVEX Biologics, Inc. class: INDUSTRY name: Moxie Clinical briefSummary: Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP. conditions: Discogenic Pain conditions: Back Pain conditions: Back Pain, Low studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: VIA Disc NP measure: Numeric Pain Rating Scale (NPRS) measure: Oswestry Disability Index (ODI) measure: Patient Satisfaction measure: Pain Medication sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Denver Spine & Pain Institute status: RECRUITING city: Greenwood Village state: Colorado zip: 80111 country: United States name: Josephine Steinbrecher role: CONTACT email: josephine@denverpaininstitute.com name: Scott Bainbridge, M.D. role: PRINCIPAL_INVESTIGATOR lat: 39.61721 lon: -104.95081 facility: The Orthopedic Institute status: RECRUITING city: Gainesville state: Florida zip: 32605 country: United States name: Carole Newell role: CONTACT email: cnewell@toi-health.com name: Ajay Antony, M.D. role: PRINCIPAL_INVESTIGATOR lat: 29.65163 lon: -82.32483 facility: Interventional Pain Specialists - Pain Clinic status: RECRUITING city: Opelousas state: Louisiana zip: 70570 country: United States name: Lisa Briggs role: CONTACT email: lisa@ipspain.org name: Albert Gros, M.D. role: PRINCIPAL_INVESTIGATOR lat: 30.53353 lon: -92.08151 facility: Premier Pain Solutions status: RECRUITING city: Asheville state: North Carolina zip: 28803 country: United States name: Courtney Musser role: CONTACT email: courtney@premierpainnc.com name: Javid Baksh, M.D. role: PRINCIPAL_INVESTIGATOR lat: 35.60095 lon: -82.55402 facility: Crystal Coast Pain Management status: RECRUITING city: New Bern state: North Carolina zip: 28560 country: United States name: Amy Harum role: CONTACT email: aharum@crystalcoastpm.com name: Kirk Harum, M.D. role: PRINCIPAL_INVESTIGATOR lat: 35.10849 lon: -77.04411 hasResults: False
nctId: NCT06345677 id: ViXe-CLP-0002 briefTitle: Clinical Trial for the Assessment of Safety, Usability and Efficacy of the Vixe Combination for OAB in Female Subjects acronym: XAVIER overallStatus: COMPLETED date: 2023-06-09 date: 2024-02-01 date: 2024-02-01 date: 2024-04-03 date: 2024-04-09 name: Vensica Therapeutics Ltd. class: INDUSTRY name: Blueclinical, Ltd. briefSummary: The goal of this interventional clinical trial is to assess the safety, usability and initial efficacy of Xeomin and Vibe combination (ViXe) compared to placebo + sham in female subjects with idiopathic Overactive Bladder. The main question\[s\] it aims to answer are: • The rate of device and drug related serious adverse events during treatment and throughout the follow up period • Investigator, subject and technician satisfaction from treatment, and • Assess the initial efficacy of the drug-device combination compared to placebo-sham combination. Participants will be treated a single time with the ViXe combination and will be followed up for a period of 12 weeks, during which they will visit the clinic after 2, 6 and 12 weeks. Participants will complete a 3-day voiding diary prior to the 6- and 12-week FU visit. conditions: Overactive Bladder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 48 type: ACTUAL name: ViXe Xombination name: Placebo + Sham measure: Adverse Events Rate measure: Usability and ease-of-use perception by investigator, subject and technician measure: Daily Urgency Urinary Incontinence measure: Total Daily Episodes measure: Urinary Urgency measure: Voiding Leaks measure: Quality of Life Queationnsaire measure: Nocturia sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHUC city: Coimbra country: Portugal lat: 40.20564 lon: -8.41955 facility: HSOG city: Guimarães country: Portugal lat: 41.44443 lon: -8.29619 facility: CHLN city: Lisboa country: Portugal lat: 38.71667 lon: -9.13333 facility: CHUSJ city: Porto country: Portugal lat: 41.14961 lon: -8.61099 facility: Hospital Lusíadas city: Porto country: Portugal lat: 41.14961 lon: -8.61099 facility: Hospital Prelada city: Porto country: Portugal lat: 41.14961 lon: -8.61099 facility: Hospital Luz Setúbal city: Setúbal country: Portugal lat: 38.5244 lon: -8.8882 facility: CHVNG city: Vila Nova De Gaia country: Portugal lat: 41.13363 lon: -8.61742 hasResults: False
nctId: NCT06345664 id: 548/2022BO1 briefTitle: Interdisciplinary E-health Based Follow-up of Preterm Born Children acronym: NeoUp overallStatus: RECRUITING date: 2023-03-01 date: 2024-10 date: 2024-12 date: 2024-04-03 date: 2024-04-08 name: University Hospital Tuebingen class: OTHER briefSummary: The aim of the study is to assess mental and somatic symptoms of preterm born children at the ages of 2, 5 and 10 by a multidisciplinary team and to evaluate an app that screens for these symptoms. Furthermore, there will be an evaluation of an intervention by our multidisciplinary team that provides recommendations for further treatment and diagnostic procedures of the children. conditions: Preterm Birth studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 90 type: ESTIMATED name: Diagnostics and intervention recommendations measure: Bayley Scales of Infant and Toddler Development measure: Wechsler Intelligence Scale for Children (WISC-V) measure: Children's Sleep Habit Questionnaire (CSHQ-DE 4-10) measure: Sleep Self Report (SSR) measure: Somatics measure: Child Behavior Checklist (CBCL) measure: Youth Self Report (YSR) measure: Diagnostic-system for mental illness for children and adolescents - III (DISYPS-III SCREEN FBB and SBB) measure: KIDSCREEN-27 (The KIDSCREEN) measure: Parent's Stress Inventory (EBI) measure: App-questions measure: Postexperimental questionnaire measure: Demographic data measure: Actigraphy measurement measure: Video of a sleeping sequence measure: Sleep cartoon for children measure: Kiddie-Sads-Present and Lifetime Version (K-SADS PL) measure: Self efficacy dealing with social situations (WIRKSOZ) measure: Group interviews sex: ALL minimumAge: 2 Years maximumAge: 10 Years stdAges: CHILD facility: University Hospital Tuebingen status: RECRUITING city: Tuebingen zip: 72076 country: Germany name: Annette Conzelmann, Prof. Dr. role: CONTACT name: Axel Franz, Prof. Dr. role: PRINCIPAL_INVESTIGATOR name: Mirja Quante, Dr. role: PRINCIPAL_INVESTIGATOR name: Andrea Bevot, Dr. role: PRINCIPAL_INVESTIGATOR name: Anna Haigis role: SUB_INVESTIGATOR name: Dorothee Fütterer, Dr. role: SUB_INVESTIGATOR name: Annette Conzelmann, Prof. Dr. role: PRINCIPAL_INVESTIGATOR name: Tobias Renner, Prof. Dr. role: PRINCIPAL_INVESTIGATOR lat: 48.52266 lon: 9.05222 hasResults: False
nctId: NCT06345651 id: 2023-03, Version 7 briefTitle: Brain Oscillation-synchronized Stimulation of the Frontal Cortex in Major Depressive Disorder acronym: BOSSFRONT2 overallStatus: RECRUITING date: 2023-09-01 date: 2025-08 date: 2025-08 date: 2024-04-03 date: 2024-04-03 name: University Hospital Tuebingen class: OTHER briefSummary: Major depressive disorder (MDD) is a common severe psychiatric disease with enormous socioeconomic costs for the patient and society alike. Current pharmacological treatments are ineffective in a substantial fraction of patients and are accompanied by unwanted side effects. Using a novel non-invasive brain stimulation method to specifically target and modulate dysfunctional brain oscillations with high spatial and temporal precision this study will investigate the efficacy of EEG-triggered transcranial magnetic stimulation to alleviate de-pressive symptomatology in patients with MDD in a double-blind randomized controlled pilot clinical trial. conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is a single-site randomized standard TMS therapy-controlled double-blind paral-lel-group design clinical trial. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: In both conditions the identical setup is used consisting of Neuronavigation, EEG and TMS. Only in the experimental condition the treatment will be EEG-informed. In the control condition the treatment will be applied indepentently of the EEG signal. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Transcranial Magnetic Stimulation measure: Montgomery-Åsberg Depression Rating Scale (MADRS) measure: MADRS (Montgomery-Åsberg Depression Rating Scale) 4 weeks after intervention measure: HDRS-17 (Hamilton Depression Rating Scale-17) measure: BDI-2 (Beck Depression Inventory-2) measure: IDS-30 (Inventory of depressive symptoms-30) measure: Response Rate measure: Remission Rate sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Tuebingen status: RECRUITING city: Tuebingen state: Baden-Wuerttemberg zip: 72076 country: Germany name: Anne Lieb, Dr. role: CONTACT phone: +4970712980483 email: anne.lieb@uni-tuebingen.de name: Andreas J. Fallgatter, Prof. role: PRINCIPAL_INVESTIGATOR name: Ulf Ziemann, Prof. role: PRINCIPAL_INVESTIGATOR name: Julia Becker-Sadzio, Dr. role: SUB_INVESTIGATOR name: Anne Lieb, Dr. role: PRINCIPAL_INVESTIGATOR lat: 48.52266 lon: 9.05222 hasResults: False
nctId: NCT06345638 id: 854343 briefTitle: Sex Hormones and Inflammatory Biomarkers in Patients With Sickle Cell Disease overallStatus: ENROLLING_BY_INVITATION date: 2024-03-01 date: 2025-04-30 date: 2025-05-31 date: 2024-04-03 date: 2024-04-03 name: University of Pennsylvania class: OTHER briefSummary: This study aims to characterize sex differences in the pathophysiology of vaso-occlusive crises (VOC) occurring among individuals with sickle cell disease (SCD).
* The study will compare neutrophil and platelet adhesion to the endothelium and real time fibrin deposition in the blood. conditions: Sickle Cell Disease conditions: Vaso-occlusive Crisis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: C-reactive protein level sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Penn Medicine University City city: Philadelphia state: Pennsylvania zip: 19104 country: United States lat: 39.95233 lon: -75.16379 facility: Pennsylvania Hospital city: Philadelphia state: Pennsylvania zip: 19107 country: United States lat: 39.95233 lon: -75.16379 facility: Hospital of the University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19143 country: United States lat: 39.95233 lon: -75.16379 hasResults: False
nctId: NCT06345625 id: 6012 briefTitle: Gait and Postural Balance Analysis During Head-motion Perturbed Standing and Walking in Older Adults acronym: BALANCAR overallStatus: RECRUITING date: 2024-04-15 date: 2027-01 date: 2028-01 date: 2024-04-03 date: 2024-04-16 name: Universiteit Antwerpen class: OTHER briefSummary: The main aim of this study is to unravel the biomechanics of postural balance reactions during head-motion perturbed standing and walking in older adults who fall, while integrating the influence of frailty, sensory functioning and cognitive processing. conditions: Aged conditions: Accidental Fall conditions: Postural Balance conditions: Gait studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Cognition name: Sensory function name: Frailty name: Biomechanical movement analysis name: Screening name: Follow up measure: Spatio-temporal parameters of gait measure: Foot placement estimator measure: Onset latency measure: Peak amplitude measure: Fixation duration measure: Gain measure: Latency measure: Fall characteristics measure: Multisensory integration measure: Digit symbol substitution test measure: Trail making test measure: Go/No Go test measure: Head Repositioning Accuracy measure: Fly test measure: Fly test measure: vHIT measure: fHIT measure: Frailty measure: Age measure: Gender measure: Medical history measure: Fall history sex: ALL minimumAge: 65 Years maximumAge: 100 Years stdAges: OLDER_ADULT facility: University of Antwerp status: RECRUITING city: Antwerp zip: 2160 country: Belgium name: Ann Hallemans, PhD role: CONTACT phone: +32 3 265 29 12 email: ann.hallemans@uantwerpen.be name: PhD role: CONTACT lat: 51.21989 lon: 4.40346 hasResults: False
nctId: NCT06345612 id: Hypoxia-Exercise-DiabetesT1 briefTitle: Impact of Eccentric Training in Hypoxia With Creatine on Metabolic Control and VO2max in Patients With Type 1 Diabetes overallStatus: RECRUITING date: 2023-11-15 date: 2025-06 date: 2025-07 date: 2024-04-03 date: 2024-04-03 name: Silesian Centre for Heart Diseases class: OTHER briefSummary: Exercise plays an important role in treatment of diabetes. In recent years exercise training in normobaric hypoxia is used in training programs for athletes and in rehabilitation and also commercially. The aim of the study is to assess the impact of eccentric training conducted in conditions of normobaric hypoxia or normoxia and creatine supplementation on metabolic control: profile and stability of glucose concentration, HbA1c value, hypoglycemia and insulin demand, as well as the level of muscle strength, VO2max and anthropometric parameters conditions: Type 1 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: hypoxia name: normoxia name: creatine supplementation name: no creatine supplementation measure: Metabolic control of diabetes measure: Time in range measure: Time below range measure: Maximum oxygen consumption (VO2max) sex: MALE minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT facility: Department of Internal Diseases, Diabetology and Cardiometabolic Disorders, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Poland status: RECRUITING city: Zabrze state: Silesia zip: 41-800 country: Poland name: Marta Wróbel, PhD role: CONTACT phone: 48606873060 email: mwrobel@sum.edu.pl lat: 50.32492 lon: 18.78576 hasResults: False