hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06319001, orgStudyIdInfo id: 2688791, briefTitle: Cardiovascular Reactivity to Physical Stress, acronym: REACT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2027-01-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Western Norway University of Applied Sciences, class: OTHER, descriptionModule briefSummary: It is well-accepted that an exaggerated blood pressure (BP) response to physical stress has a prognostic value, indicating a higher cardiovascular risk (e.g., sudden cardiac death, myocardial infarction, future hypertension, and left ventricular hypertrophy). However, there is a limited understanding of the underlying mechanisms and therapuetic strategies modulating this response. Therefore, this pilot project aims to explore whether one session of low-volume high-intensity interval training (low-volume HIIT) or combined intermittent heat and cold bath (sauna+cold bath) can decrease BP responses to physical stress. Furthermore, the secondary goal is to investigate whether one brief session learning about positive stress expectations magnifies the decrease in BP following low-volume HIIT and sauna+ cold bath., conditionsModule conditions: Blood Pressure, conditions: Stress, Physiological, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Combined randomized controlled trial with two parallel groups, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: Low-volume high intensity exercise, interventions name: Combined intermittent sauna and cold water bath (sauna+cold bath)., outcomesModule primaryOutcomes measure: Blood pressure (unit: mmHg) response to laboratory stressors, secondaryOutcomes measure: Resting blood pressure (mmHg)., secondaryOutcomes measure: Endothelial function (% dilation), secondaryOutcomes measure: Subjective ratings of expectancies (point score)., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Western Norway University of Applied Sciences, status: RECRUITING, city: Bergen, state: Vestland, zip: 5063, country: Norway, contacts name: Ann-Katrin Grotle, role: CONTACT, phone: +4790960580, email: ann-katrin.grotle@hvl.no, geoPoint lat: 60.39299, lon: 5.32415, hasResults: False
protocolSection identificationModule nctId: NCT06318988, orgStudyIdInfo id: S67030, briefTitle: Outcomes of Different Treatment Options in Chronic Venous Disease, acronym: VOS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-11-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, descriptionModule briefSummary: This study aims to describe conservative and invasive treatments for patients with chronic venous disease (CVD) in Belgium, and their association with clinical and patient-reported outcomes during a follow-up of 24 months., conditionsModule conditions: Chronic Venous Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Radiofrequency ablation using Closure fast, interventions name: Aethoxysclerol, interventions name: Daflon, interventions name: Compression stocking, outcomesModule primaryOutcomes measure: Change in Chronic Venous Insufficiency QOL questionnaire- 20 (CIVIQ-20) score, secondaryOutcomes measure: Intervention as secondary/add-on treatment, secondaryOutcomes measure: The change in the Chronic Venous Insufficiency QOL questionnaire-20 score (CIVIQ-20), secondaryOutcomes measure: The change in the clinical part of the Clinical, Etiological, Anatomical and Pathophysiological classification (CEAP classification), secondaryOutcomes measure: The change in the revised Venous Clinical Severity Score (rVCSS), secondaryOutcomes measure: The change in the symptoms, recorded with a questionnaire, secondaryOutcomes measure: The change in satisfaction score, secondaryOutcomes measure: Adverse Events (AEs)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06318936, orgStudyIdInfo id: 22-677, briefTitle: Respiratory Syncytial Virus (RSV) Burden in Older Adults in Primary Care in The Netherlands, acronym: RAPID, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: UMC Utrecht, class: OTHER, collaborators name: Janssen-Cilag B.V., descriptionModule briefSummary: RSV infection is a leading cause of medical care in older adults, sometimes leading to hospital admission and severe outcomes. Although the majority of RSV infections are managed outside hospitals, little is known on the burden of RSV in older adults in the primary care setting. Accurate estimates of the RSV burden in primary care is particularly relevant since vaccines against RSV infection in older adults will likely become available for the general population soon. The use of high-quality point-of-care (POC) molecular viral diagnostics allows to identify RSV infected older adults and would therefore contribute to fill one of the most important gaps in knowledge facilitating implementation of RSV vaccination of older adultsWith this prospective, observational study, we aim to define the disease burden of RSV infection in older adults in the primary care setting., conditionsModule conditions: RSV Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Burden of medically attended RSV infection in the Dutch primary care, secondaryOutcomes measure: RSV-related health care consumption and indirect costs in older adults, secondaryOutcomes measure: Proportion of medically attended RSV infection amongst all medically attended acute respiratory infections in older adults in the primary care setting, secondaryOutcomes measure: Association between disease severity and several clinical and demographic parameters (e.g. age, cardiopulmonary comorbidity, smoking status, chronic immunosuppressive medication use) and RSV burden (by disease severity and healthcare usage), secondaryOutcomes measure: Incidence of RSV-related secondary bacterial pneumonia events and antibiotic use, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Medical Center Utrecht, status: RECRUITING, city: Utrecht, zip: 3584CX, country: Netherlands, contacts name: Joanne Wildenbeest, MD, PhD, role: CONTACT, phone: 0031887563776, email: J.G.Wildenbeest@umcutrecht.nl, geoPoint lat: 52.09083, lon: 5.12222, hasResults: False
protocolSection identificationModule nctId: NCT06318910, orgStudyIdInfo id: MU-SRF-RS-27 C/66, briefTitle: Customized Foot Orthoses on Muscle Activity During Standing and Gait in Plantar Heel Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, descriptionModule briefSummary: The present study will use a randomized controlled trial (RCT) to determine the effectiveness of customized foot orthosis (CFO) for the treatment of patients with PHP. Three treatment groups including the CFO without wedge, the CFO with wedge type 1 (W1), and the CFO with wedge type 2 (W2) will be randomly assigned to each participant by a computer-generated randomization. The opaque-sealed envelopes will be used to allocate the groups of participant., conditionsModule conditions: Foot Orthoses, conditions: Fasciitis, Plantar, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: The present study will use a randomized controlled trial (RCT) to determine the effectiveness of CFO for the treatment of patients with PHP. Three treatment groups including the CFO without wedge, the CFO with W1, and the CFO with W2 will be randomly assigned to each participant by a computer-generated randomization. The opaque-sealed envelopes will be used to allocate the groups of participant., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants will be allocated to the control (CFO without wedge) or experimental (CFO with W1 or W2) groups according to the seal-envelop randomization technique. Then, they will be assessed all outcomes for the baseline including pain intensity, foot function, lower-extremity muscle activity during gait and standing by the 2nd physical therapist. And the participants will receive the assigned treatment by the 1st physical therapist., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: orthotic wedge, interventions name: CFO, outcomesModule primaryOutcomes measure: Pain intensity and foot function, primaryOutcomes measure: EMG of lower leg muscles, otherOutcomes measure: Subjective assessment, otherOutcomes measure: Physical assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06318897, orgStudyIdInfo id: 2023-0645, secondaryIdInfos id: NCI-2024-02384, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-30, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2027-09-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: To look at the effectiveness of the combination of pembrolizumab, carboplatin, and paclitaxel in participants with stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer., conditionsModule conditions: Stage 1 cT1b-T1cN0M0, conditions: Triple Negative Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Carboplatin, interventions name: Paclitaxel, interventions name: Pembrolizumab, interventions name: Doxorubicin, interventions name: Cyclophosphamide, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Oluchi Oke, MD, role: CONTACT, phone: 832-729-8362, email: oukaegbu@mdanderson.org, contacts name: Oluchi Oke, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
protocolSection identificationModule nctId: NCT06318871, orgStudyIdInfo id: 23-688, briefTitle: A Phase 0 Pilot Study of Memory-like Natural Killer (NK) Cell Immune Therapy in Combination With N-803 in Patients With Renal Cell Carcinoma or Urothelial Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2030-02-28, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Dana-Farber Cancer Institute, class: OTHER, collaborators name: Kidney Cancer Association, collaborators name: ImmunityBio, Inc., descriptionModule briefSummary: The goal of this research study is to establish the safety and then to explore the effectiveness of infusing the combination of cytokine-induced memory-like (CIML) natural killer (NK) cells, a type of immune cell in the blood that is collected and bathed in special proteins to help identify and treat curtained advanced cancers, combined with N-803, a medication that increases the activity of Interleukin-15, which is a cytokine that activates immune cells, in advanced clear cell renal cell carcinoma and urothelial carcinoma.Names of the study therapies involved in this study are/is:* CIML NK cell therapy (a NK cell therapy)* N-803 (a type of recombinant human IL-15 superagonist), conditionsModule conditions: Renal Carcinoma, conditions: Renal Cell Carcinoma, conditions: Urothelial Carcinoma, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: Cytokine Induced Memory-like Natural Killer (CIML NK) Cells, interventions name: N-803, outcomesModule primaryOutcomes measure: Feasibility Failure Rate (FFR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Wenxin Xu, MD, role: CONTACT, phone: 617-632-6534, email: wenxin_xu1@dfci.harvard.edu, contacts name: Wenxin Xu, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Dana-Farber Cancer Institute, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Wenxin Xu, MD, role: CONTACT, phone: 617-632-6534, email: Wenxin_Xu1@dfci.harvard.edu, contacts name: Wenxin Xu, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
protocolSection identificationModule nctId: NCT06318858, orgStudyIdInfo id: MU-CIRB 2022/313.1411, briefTitle: Daily and Weekly Iron Supplementation in Infants, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-15, primaryCompletionDateStruct date: 2024-08-14, completionDateStruct date: 2024-10-14, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, collaborators name: Suranaree University of Technology, descriptionModule briefSummary: This study aims to compare the efficacy of daily iron supplementation and weekly iron supplementation in infants aged 6-12 months on the prevalence of anemia, hemoglobin level, and serum ferritin levels. Infants will be enrolled at 6 months and will be randomly assigned to receive either daily or weekly iron supplementation for the first 3 months and will be followed by weekly iron supplementation for another 3 months., conditionsModule conditions: Anemia, conditions: Iron Status, conditions: Infants, conditions: Iron, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: group 1: daily iron syrup supplementation group 2: weekly iron syrup supplementation, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: Letter codes were assigned to the iron syrup and the placebo by researchers who have not involved in the study. The codes have been kept until data analysis and report writing are complete., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Iron supplement, outcomesModule primaryOutcomes measure: Anemia status, primaryOutcomes measure: Iron status, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Length, secondaryOutcomes measure: Dietary intake, secondaryOutcomes measure: Head circumference (HC), otherOutcomes measure: Hemoglobin typing, otherOutcomes measure: C-reactive protein (CRP), otherOutcomes measure: Alpha-1 acid glycoprotein (AGP), otherOutcomes measure: Serum transferrin receptor, otherOutcomes measure: Serum Retinol Binding Protein (RBP), eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule locations facility: Samphran District Hospital, status: RECRUITING, city: Sam Phran, state: Nakhon Pathom, zip: 73110, country: Thailand, contacts name: Tinnakorn Chuenchom, MD, role: CONTACT, phone: 6634311021, phoneExt: 105, contacts name: Somchai Janelapwattanakul, MD, role: CONTACT, phone: 6634352052, phoneExt: 4001, geoPoint lat: 13.72698, lon: 100.21526, hasResults: False
protocolSection identificationModule nctId: NCT06318845, orgStudyIdInfo id: 2302CS-1, briefTitle: Phase 1 Study to Evaluate the Safety and Pharmacokinetic Drug Interaction of DHP2302R1 and DHP2302R2, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-07-19, completionDateStruct date: 2024-08-02, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Daehwa Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to investigate the safety and drug interaction of DHP2302R1 and DHP2302R2 when administered alone versus in combination in healthy South Korean adult participants., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ACTUAL, armsInterventionsModule interventions name: DHP2302R1, interventions name: DHP2302R2, outcomesModule primaryOutcomes measure: AUClast of DHP2302R1 and DHP2302R2, primaryOutcomes measure: Cmax of DHP2302R1 and DHP2302R2, secondaryOutcomes measure: Tmax of DHP2302R1 and DHP2302R2, secondaryOutcomes measure: AUC0-48 of DHP2302R1 and DHP2302R2, secondaryOutcomes measure: AUCinf of DHP2302R1 and DHP2302R2, secondaryOutcomes measure: t1/2 of DHP2302R1 and DHP2302R2, secondaryOutcomes measure: CL/F of DHP2302R1 and DHP2302R2, secondaryOutcomes measure: Vz/F of DHP2302R1 and DHP2302R2, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: H Plus Yangji Hospital, city: Seoul, state: Gwanak-gu, zip: 08779, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
protocolSection identificationModule nctId: NCT06318832, orgStudyIdInfo id: 124609, briefTitle: Optimizing a Wellbeing Program for Care-partners of Those With SCI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Lawson Health Research Institute, class: OTHER, descriptionModule briefSummary: Spinal cord injuries (SCI) have a devastating effect not only on individuals incurring the life changing event, but also on those who are involved in their care. Family care-partners of those with SCI (fcSCI) may experience significant negative effects including impaired mental health, high levels of burden, poor adjustment to role, decreased quality of life and strain on relationships. Cognitive behaviour therapy (CBT) is an evidence-based treatment strategy that helps individuals recognize and challenge their unhelpful thoughts and behaviours that contribute to their mental health concerns. However, barriers such as availability to specialized care, costs, rural and remote location, or concerns about stigma may limit access to care. Internet delivered CBT (ICBT) has the potential to reach a much wider group of people that may have unequal access to health care.In a previous feasibility study, the team demonstrated the preliminary effectiveness of a tailored ICBT Wellbeing program for fcSCI. However, our understanding of which components of the program can result in optimal management is limited. The main purpose of this study is to evaluate the effectiveness of different components of the Wellbeing program including: therapist guidance, peer support groups, and booster sessions on symptoms of depression among fcSCI. The team will evaluate which intervention components result in meaningful improvement in symptoms of depression. Through collaborations with SCI community organizations and rehabilitation institutions, participants will be recruited across Canada. The researchers will also develop a model to examine the most cost-effective intervention package from the different components. The Wellbeing for fcSCI program can provide personalized service to individuals while being flexible and easily accessible, improving overall wellbeing and access to health care services., conditionsModule conditions: Internet-Delivered Cognitive Behavioural Therapy, conditions: Depression, conditions: Anxiety, conditions: Spinal Cord Injuries, conditions: Caregiver Burnout, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 154, type: ESTIMATED, armsInterventionsModule interventions name: ICBT, outcomesModule primaryOutcomes measure: Change in depression, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False