hackint0sh/New-Dataset huggingface dataset:
The study will test the hypothesis that DP8α Tregs expressing CD73, whose frequency in blood increases stably after non-rejected kidney transplants, but not when patients have undergone or will subsequently undergo rejection, are enriched in donor-specific cells, which would be a strong argument in favor of a direct role for these Tregs in preventing transplant rejection, through their ability to inhibit immune responses directed against donor alloantigens. conditions: Kidney Transplant Tolerance studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 15 type: ESTIMATED measure: To test the role of donor-specific DP8α Tregs in preventing kidney transplant rejection. measure: Determine whether the increased anti-donor reactivity of the patient's DP8α Tregs after transplantation results from the amplification among them of clones and establish, if possible, the anti-donor reactivity of amplified clones. measure: Determine whether clones of DP8α Tregs (reactive or not to donor antigens) are reactive to F. prausnitzii bacteria. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nantes University Hospital status: RECRUITING city: Nantes state: Loire-Atlantique zip: 44093 country: France name: Christophe MASSET, PH role: CONTACT phone: 33 2 76 64 39 61 email: christophe.masset@chu-nantes.fr lat: 47.21725 lon: -1.55336 hasResults: False
nctId: NCT06271330 id: AP_JBD_FarWest_004 briefTitle: Multicenter Real-life Observational Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With AMD. acronym: FAR-WEST overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2026-09 date: 2024-02-21 date: 2024-02-21 name: Nantes University Hospital class: OTHER name: Rennes University Hospital briefSummary: Age-related macular degeneration (AMD) is a degenerative retinal disease. The prognosis of the exudative form was transformed by the introduction of the anti-VEGF monoclonal antibody treatments ranibizumab \[1\] and aflibercept \[2\] in the 2010s. In 2022, a new molecule, Faricimab, proved its efficacy in exudative AMD. It is a bi-specific monoclonal antibody against VEGF-A and ANG2. The drug has been granted marketing authorization in France, with reimbursement due to begin in October 2023 for naïve patients as well as for those already treated with ranibizumab or aflibercept. The main advantage of this compound \[3\] is that it extends the injection interval in the Treat and Extend (T\&E) protocol, which is more extensive than with previous anti-VEGF agents.
As the treatment will be on sale in pharmacies from October 2023, a switch study from previous anti-VEGF drugs to faricimab would contribute to an initial real-life evaluation of the drug in this indication. conditions: AMD studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Faricimab measure: Difference in number of weeks between previous treatment (ranibizumab or aflibercept) and after 6 months of Faricimab treatment. measure: Difference between time to recurrence before switch and after switch. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ducloyer city: Nantes zip: 44000 country: France name: Jean-Baptiste Ducloyer, MD role: CONTACT phone: 02 40 08 46 51 email: jeanbaptiste.ducloyer@chu-nantes.fr name: Yann Maucourant, MD role: CONTACT phone: 85 658 email: Yann.MAUCOURANT@chu-rennes.fr lat: 47.21725 lon: -1.55336 hasResults: False
nctId: NCT06271317 id: AP_CL_001 briefTitle: Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy. French Multicenter Study overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-03 date: 2027-03 date: 2024-02-21 date: 2024-02-21 name: Nantes University Hospital class: OTHER briefSummary: The purpose of this study is to evaluate the impact about complications between the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve)) and conventional sleeve gastrectomy technique conditions: Obesity studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Study postoperative morbidity after nissen sleeve gastrectomy in Nantes measure: postoperative morbidity of nissen sleeve gastrectomy with sleeve gastrectomy in France sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06271304 id: BLUES briefTitle: Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder acronym: BLUES overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-03-01 date: 2026-06-01 date: 2024-02-21 date: 2024-04-17 name: Mental Health Services in the Capital Region, Denmark class: OTHER briefSummary: The study investigates whether add-on treatment with eyewear that blocks the short wavelengths of visible light (\<500nm) reduces manic symptoms and improves sleep in patients receiving outpatient treatment as usual for bipolar disorder.
After this initial intervention phase, the eyewear is used daily for 3 months in either antimanic dose (14 hours) or maintenance dose (2 hours before bedtime). conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Outcome assessors will be blinded to the treatment assignment. At the beginning of each assessment, participants will be instructed not to describe or discuss their glasses with the assessor. Because the two types of glasses are of different color (clear (LF) and orange (BB)), we cannot guarantee a full blinding of the participants. Participants will be informed that we are studying the effects of two different types of light filters without more detail so they will not be provided with certain knowledge of which condition is expected to yield the largest effect. We will assess the integrity of the blind by asking participants whether they think they received glasses with high or low filtration lenses at the end of the study. Participants will be discouraged from actively seeking information about sleep glasses during the study primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants are instructed not to discuss the appearance of their designated eyewear with their care providers or the investigator or outcome assessor. Participants are not informed of the exact filtration level of their eyewear. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Blue blocking eyewear name: Low filtration eyewear measure: Manic symptoms measure: Mood instability measure: Objective sleep quality measure: Objective sleep quality measure: Subjective sleep quality measure: Subjective sleep quality sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
nctId: NCT06271291 id: 23-000161 id: NCI-2024-00504 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-000161 type: OTHER domain: Mayo Clinic in Rochester id: P30CA015083 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA015083 id: U01CA210138 type: NIH link: https://reporter.nih.gov/quickSearch/U01CA210138 id: U24CA274496 type: NIH link: https://reporter.nih.gov/quickSearch/U24CA274496 briefTitle: Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-05-01 date: 2029-05-01 date: 2024-02-21 date: 2024-03-20 name: Mayo Clinic class: OTHER name: National Cancer Institute (NCI) briefSummary: This study evaluates individuals without pancreatic cancer, but who have been determined to be at higher-than-average lifetime risk of developing pancreatic cancer to help detect pancreatic cancer or other cancers at an earlier time when they might be more easily treated and cured. conditions: Pancreatic Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 15000 type: ESTIMATED name: Non-Interventional Study measure: Develop a biobank of biospecimens and data of subjects without pancreatic cancer who are at high risk for pancreatic cancer measure: Follow subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope city: Duarte state: California zip: 91010 country: United States name: Ajay Goel, Ph.D. role: CONTACT phone: 626-256-4673 phoneExt: 85200 name: Ajay Goel, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 34.13945 lon: -117.97729 facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Shounak Majumder, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 facility: University of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15232 country: United States name: Randall Brand, M.D. role: CONTACT phone: 412-864-7516 lat: 40.44062 lon: -79.99589 hasResults: False
nctId: NCT06271278 id: 2023-17 briefTitle: The Effect of Emotional Freedom Techniques Application on Nurses overallStatus: RECRUITING date: 2023-11-02 date: 2024-02-28 date: 2024-02-28 date: 2024-02-21 date: 2024-02-22 name: Gurkan KAPIKIRAN class: OTHER briefSummary: Nurses working in surgical intensive care units face numerous health and safety stressors. The introduction of new health technologies, medical devices (such as bedside monitors, pump and perfuser devices, and mechanical ventilators), and changing health environments have contributed to increased work stress among nurses. This, in turn, has had negative effects on their physical and mental health outcomes. One of the hazards associated with medical devices is alarm fatigue. Noise pollution caused by bells, beeps, and horns in intensive care units can lead to alarm fatigue, defined as desensitisation to monitor alarms. Nurses are particularly susceptible to this due to their constant exposure to these sounds, which can also cause stress. Occupational stress is a recognised issue in this demanding field, characterised by disproportionate workloads and negative effects on performance.Work-related stress can lead to a loss of compassion towards patients and an increase in malpractice, negatively affecting the quality of care. Thus, this study aimed to investigate the impact of applying emotional freedom techniques on work-related stress and alarm fatigue experienced by nurses working in surgical intensive care units. conditions: Occupational Stress conditions: Alert Fatigue, Health Personnel studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study was conducted as a randomised controlled study with experimental and control groups. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: Participants will be blinded to their group assignment. The subjects will be selected in a randomized order using software. Data collection will be conducted without involvement from research analysts. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 144 type: ESTIMATED name: Emotional Freedom Technique measure: Subjective Units of Disturbance Scale measure: Alarm Fatigue Scale measure: The General Work Stress Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inonu University Turgut OzaL Medical Center status: RECRUITING city: Malatya zip: 44090 country: Turkey name: Turgut Ozal Medical Center role: CONTACT phone: +904223770100 email: totm@inonu.edu.tr role: CONTACT email: gurkankpkrn@gmail.com name: Gurkan Kapikiran, Ph.D role: PRINCIPAL_INVESTIGATOR name: Seher Çevik Aktura, Ph.D role: SUB_INVESTIGATOR name: Şerafettin Okutan, Ph.D role: SUB_INVESTIGATOR name: Remziye Cici, Ph.D role: SUB_INVESTIGATOR lat: 38.35018 lon: 38.31667 hasResults: False
nctId: NCT06271265 id: 402-C-125 briefTitle: Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-07 date: 2025-07 date: 2024-02-21 date: 2024-02-21 name: Pacira Pharmaceuticals, Inc class: INDUSTRY briefSummary: This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs. bupivacaine HCl for postsurgical analgesia in pediatric subjects aged 0 to less than 6 years of age undergoing cardiac surgery, utilizing local infiltration analgesia (LIA). conditions: Postoperative Pain studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: EXPAREL name: bupivacaine measure: The following model-predicted PK endpoint will be determined: measure: The following model-predicted PK endpoint will be determined: measure: The following model-predicted PK endpoint will be determined: measure: The following model-predicted PK endpoint will be determined: measure: The following model-predicted PK endpoint will be determined: measure: The following model-predicted PK endpoint will be determined: measure: Vitals change from Baseline: measure: Vitals change from Baseline: measure: Vitals change from Baseline: measure: Vitals change from Baseline: measure: Vitals change from Baseline: measure: Incidence of treatment-emergent adverse events (TEAEs) measure: Incidence of adverse events of special interest (AESIs) measure: Incidence of serious adverse events (SAEs) sex: ALL minimumAge: 0 Years maximumAge: 6 Years stdAges: CHILD hasResults: False
nctId: NCT06271252 id: OriCAR-017 US-P1 briefTitle: A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-12-01 date: 2026-04-01 date: 2024-02-21 date: 2024-04-16 name: OriCell Therapeutics Co., Ltd. class: INDUSTRY briefSummary: The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma.
RIGEL Study conditions: Neoplasms, Plasma Cell conditions: Neoplasms by Histologic Type conditions: Neoplasms conditions: Hemostatic Disorders conditions: Vascular Diseases conditions: Cardiovascular Diseases conditions: Paraproteinemias conditions: Blood Protein Disorders conditions: Hematologic Diseases conditions: Hemorrhagic Disorders conditions: Lymphoproliferative Disorders conditions: Immunoproliferative Disorders conditions: Immune System Diseases conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 81 type: ESTIMATED name: OriCAR-017 measure: Maximum tolerated dose (MTD) of OriCAR-017 US-P1 measure: Dose-limiting toxicity (DLT) measure: Evaluate PK parameters of OriCAR-017 in subjects with relapsed/refractory MM measure: Evaluate PD parameters of OriCAR-017 in subjects with relapsed/refractory MM measure: Assessment of Duration of Response (DOR) of treatment in patients with RR/MM measure: Progress-Free Survival (PFS) of treatment in patients with RR/MM measure: Assessment of Overall Survival (OS) of treatment in patients with RR/MM measure: Assessment of MRD negative Rate measure: Assessment of Overall Response Rate (ORR) measure: Assessment of Disease Control Rate (DCR) measure: Assessment of Clinical Benefit Rate (CBR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northside Hospital city: Atlanta state: Georgia zip: 30342 country: United States name: Melhem Solh role: CONTACT email: msolh@bmtga.com name: Caitlin Guzowski role: CONTACT email: caitlin.guzowski@northside.com lat: 33.749 lon: -84.38798 hasResults: False
nctId: NCT06271239 id: U1111-1299-9167 id: 65318722.0.0000.5336 type: OTHER domain: IRB-Pontifical Catholic University of Rio Grande do Sul id: RBR-2tq2jky type: OTHER domain: The Brazilian Registry of Clinical Trials (ReBEC) briefTitle: Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-12-31 date: 2025-03-30 date: 2024-02-21 date: 2024-02-21 name: Pontificia Universidade Católica do Rio Grande do Sul class: OTHER name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. briefSummary: This study employs a randomized, controlled, paired, single-blind clinical trial design. The targeted demographic comprises individuals aged 60 and above. Following the initial assessment, participants will be randomly allocated to two groups: the Intervention Group (ViviFrail) and the Group Suggestions for a Healthy Life (CG), maintaining a 1:1 allocation ratio. Both the ViviFrail group and CG group will exhibit homogeneity in terms of their clinical characteristics and functional performance. The allocation of participants into respective groups will remain concealed from all assessors, ensuring a single-blind approach.
Conversely, the Group Suggestions for a Healthy Life (CG) comprising 25 participants will receive exercise suggestions and guidance to maintain a healthy routine for a duration of three months. Subsequently, participants in the CG will undergo the VIVIFRAIL® program intervention for an additional three months. conditions: Frailty conditions: Aging conditions: Physical Disability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In the Intervention Group (ViviFrail), participants will perform a six-month VIVIFRAIL® protocol-based exercise, adapted to their clinical profile.
Sample size determination was based on Casas-Herrero et al. (2022). The study assessed the impact of multicomponent training on intrinsic functional capacity, utilizing the Short Physical Performance Battery (SPPB) to gauge balance, gait speed, and lower limb strength on a 0 to 12 scale. Control group: -0.33±1.60 point difference; Treatment group: 1.07±1.52 point difference.
Considering a 5% alpha and 80% power, 20 participants per group are required. Anticipating a 25% dropout rate, as observed by Tiecker (2021), we plan to enroll 25 participants per group. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The assessments will be conducted by trained researchers whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Intervention group (ViviFrail) name: Group Suggestions for a Healthy Life (CG) measure: Short physical performance battery measure: Barthel Index measure: ICOPE questionnaire measure: Lawton Scale measure: 4-meter gait speed measure: Five Times Sit-to-Stand measure: Balance test in three positions measure: Self-perceived health measure: Adverse health outcomes - falls measure: Adverse health outcomes - hospitalization measure: Adverse health outcomes - institutionalization sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06271226 id: OMUKAEK 2022/75 id: OMUKAEK 2022/75 type: OTHER domain: ONDOKUZ MAYIS UNIVERSTY briefTitle: The Effect of Acupressure Applied to Icu on Pain and Physiological Parameters acronym: EFFECTOFACU overallStatus: RECRUITING date: 2023-03-20 date: 2024-06-30 date: 2024-12-31 date: 2024-02-21 date: 2024-02-21 name: Ondokuz Mayıs University class: OTHER briefSummary: The aim of this experimental study is to determine the effect of acupressure applied to intensive care patients on pain and physiological parameters (blood pressure, heart rate, respiration and oxygen saturation).
Participants will be included in the study after obtaining consent from patients who were treated in the intensive care unit, who scored 9 and above on the glaskow coma scale by evaluating their consciousness status, and had pain after evaluating their pain. conditions: Intensive Care Patients conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Since there will be variability in patient admissions to intensive care units, block randomization will be used. Three different groups will be coded with different letters (A,B,C) and blocks will be created. Then randomization will be performed by assigning random numbers on the computer. The letters determined in the randomization will be written in closed envelopes and stored, and the randomization process will be carried out by an independent researcher. After the patient who meets the inclusion criteria is identified, the independent researcher will be contacted to find out which group the patient is in. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: participant and statistical analysis expert is blind. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: acupressure name: placebo acupressure name: control group measure: neurological evaluation measure: evaluation of pain measure: evaluation of physiological parameters measure: evaluation of physiological parameters sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Giresun Eğitim Araştırma Hastanesi status: RECRUITING city: Giresun zip: 28000 country: Turkey name: emine yaman lezki role: CONTACT phone: +9005458026622 email: e_yaman95@hotmail.com lat: 40.91698 lon: 38.38741 hasResults: False
nctId: NCT06271213 id: 303841 briefTitle: The Gut-Lung Axis and Respiratory Illness in Children overallStatus: RECRUITING date: 2024-02-04 date: 2027-11-01 date: 2028-05-01 date: 2024-02-21 date: 2024-02-21 name: NHS Greater Glasgow and Clyde class: OTHER name: University of Glasgow briefSummary: The goal of this single-centre observational study conducted at the Royal Hospital for Children in Glasgow, Scotland, is to employ a multi-omics approach to investigate the "gut-lung axis" in health and disease.
* dietary information (food diary and/or food frequency questionnaire) to assess relationships between diet and the gut-lung axis. conditions: Respiration Disorders conditions: Respiratory Disease conditions: Asthma in Children conditions: Wheezing conditions: Gastro-Intestinal Disorder conditions: Healthy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 150 type: ESTIMATED name: observational only - no interventions as part of study measure: Assess differences in gut and lung microbiota diversity between groups measure: Assess changes in gut and lung microbiota in children with asthma receiving biologics measure: Determine mediators of gut-lung axis in health and disease measure: Nutritional influence in gut-lung axis measure: Multi-omics integration sex: ALL minimumAge: 0 Years maximumAge: 16 Years stdAges: CHILD facility: NHS Greater Glasgow and Clyde: Royal Hospital for children, Glasgow status: RECRUITING city: Glasgow country: United Kingdom name: Ross J Langley, MRCPCH role: CONTACT phone: 0141 451 6683 email: ross.langley@ggc.scot.nhs.uk lat: 55.86515 lon: -4.25763 hasResults: False