hackint0sh/New-Dataset huggingface dataset:
IBDQ, SCCAIQ, CRP, TAC, TNF-a will be measured before and after the intervention. conditions: Ulcerative Colitis conditions: Primary Sclerosing Cholangitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Bromlein name: Placebo measure: SCCAIQ measure: IBDQ measure: Serum TAC measure: Serum hsCRP measure: Serum TNF-a sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azita Hekmatdoost status: RECRUITING city: Tehran state: Middle East zip: 19835 country: Iran, Islamic Republic of name: Azita Hekmatdoost, MD, PhD role: CONTACT phone: +989123065084 email: a_hekmat2000@yahoo.com lat: 35.69439 lon: 51.42151 hasResults: False
nctId: NCT06351683 id: 24-066-2 id: P30AG067988 type: NIH link: https://reporter.nih.gov/quickSearch/P30AG067988 briefTitle: Testing MitoQ on Lower Urinary Tract Symptoms in Older Women With Metabolic Syndrome acronym: Mito-LUTS overallStatus: RECRUITING date: 2024-04-03 date: 2025-12 date: 2025-12 date: 2024-04-08 date: 2024-04-25 name: Iman Al-Naggar, PhD class: OTHER name: National Institute on Aging (NIA) name: American Urological Association name: Urology Care Foundation name: Claude D. Pepper Older Americans Independence Center (OAIC) briefSummary: The goal of this clinical trial is to test the effect of a supplement called MitoQ (mitoquinol mesylate) on bladder symptoms such as urgency and frequency in women aged 50-75 years old who have the metabolic syndrome. The main questions it aims to answer are:
Participants will take 2 capsules of the study drug every morning for 4 months, answer many questions about their health including questions about their bladder health, perform physical and cognitive testing, give blood and urine samples, collect urine over 24 hour periods 3 times over the 4 months of the study, complete 3 day bladder diaries about how much they drink and void, undergo electrocardiograms, have their vitals and measurements (weight, height, waist circumference) taken, participate in 4 visits to the clinical research area and participate in many phone calls of varying length. Researchers will compare participants who were taking capsules containing MitoQ and participants taking capsules not containing MitoQ to see if MitoQ improves their bladder symptoms (urgency, frequency, nocturia, incontinence, etc.) conditions: Lower Urinary Tract Symptoms conditions: Overactive Bladder Syndrome studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-blinded. Pharmacy will randomize and dispense capsules. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: MitoQ (mitoquinol mesylate) name: Placebo measure: Overactive Bladder Symptom Score (OABSS) measure: Three-day bladder voiding diary sex: FEMALE minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UConn Health status: RECRUITING city: Farmington state: Connecticut zip: 06030 country: United States name: Lisa Kenyon-Pesce role: CONTACT phone: 860-679-2305 email: kenyon-pesce@uchc.edu name: Peter C Albertsen, MD role: SUB_INVESTIGATOR name: George A Kuchel, MD role: SUB_INVESTIGATOR name: Jenna M Bartley, PhD role: SUB_INVESTIGATOR name: Oh Sung Kwon, PhD role: SUB_INVESTIGATOR lat: 41.71982 lon: -72.83204 hasResults: False
nctId: NCT06351670 id: 1109/2024 briefTitle: Personalised Monitoring of Early and Intermediate Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression acronym: SUDETES overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-07 date: 2027-07 date: 2024-04-08 date: 2024-04-09 name: Medical University of Vienna class: OTHER name: University Medical Centre Ljubljana name: Centre Hospitalier Universitaire Dijon name: Queen's University, Belfast name: University of Zurich name: Vista Klinik name: Fundacion Clinic per a la Recerca Biomédica briefSummary: The goal of this prospective, multinational, multicenter observational study is to to predict conversion of early and intermediate AMD with functional vision to advanced AMD with irreversible loss of vision on an individual-based level over 2 years. The main objectives of this study are:
No intervention will be performed during the study since no treatment is yet available within Europe. As soon as treatment is approved in the EU, patients in this cohort might receive treatment according to availability in their respective country and standard of care. If treatment will be performed, it will be as standard of care outside the study according to each country's standard of care and by EMA label. conditions: Age-Related Macular Degeneration studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: To characterise and quantify focal and global changes of the retina by retinal imaging to identify patients at risk for conversion to advanced AMD. measure: To identify and quantify disease progression-related biomarkers measure: To evaluate monitoring of AMD progression assisted by AI algorithms sex: ALL minimumAge: 55 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06351657 id: 1088/2024 briefTitle: Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression acronym: APENNINES overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-07 date: 2027-07 date: 2024-04-08 date: 2024-04-09 name: Medical University of Vienna class: OTHER name: University Medical Centre Ljubljana name: Centre Hospitalier Universitaire Dijon name: University of Zurich name: Vista Klinik name: Queen's University, Belfast name: Fundacion Clinic per a la Recerca Biomédica briefSummary: The goal of this prospective, multinational, multicenter observational study is to assess and predict progression in non-foveal, non-vision compromising atrophic AMD on an individual-based level over two years. The main objectives of this study are:
No intervention will be performed during the study since no treatment is yet available within Europe. As soon as treatment is approved in the EU, patients in this cohort might receive treatment according to availability in their respective country and standard of care. If treatment will be performed, it will be as standard of care outside the study according to each country's standard of care and by EMA label. conditions: Age-Related Macular Degeneration conditions: Geographic Atrophy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: To characterise and quantify focal and global changes of the retina by retinal imaging to identify patients at risk for fast geographic atrophy (GA) progression measure: To identify and quantify disease progression-related biomarkers measure: To evaluate monitoring AMD progression using approved AI algorithms. sex: ALL minimumAge: 55 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06351644 id: STUDY-24-00244 briefTitle: ON 123300 (Narazaciclib) and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-06-03 date: 2028-06-05 date: 2028-06-05 date: 2024-04-08 date: 2024-04-08 name: Adriana Rossi class: OTHER briefSummary: Multiple myeloma (MM) is a malignancy characterized by uncontrolled proliferation of plasma cells for which there is an urgent and unmet need to develop new, effective therapeutics. Onconova Therapeutics has developed a first-in-class oral inhibitor of CDK4 and ARK5 ON 123300 (NARAZACICLIB) which shows potent anti-myeloma activity in vitro and in vivo in preclinical models, and is undergoing evaluation in Phase 1-2 trials worldwide.
In this study, the researchers will test the safety and preliminary efficacy of inhibition of CDK4 and ARK5 by ON 123300 (NARAZACICLIB) in combination with dexamethasone in myeloma patients in a Phase I/II clinical trial. conditions: Relapsed and/or Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a single arm optimal biologic dose finding phase I/II clinical trial. primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: ON 123300 name: Dexamethasone measure: Phase I: The optimal biological dose (OBD) of the combination of ON 123300 (NARAZACICLIB) and dexamethasone measure: Phase I: Dose-Limiting Toxicity (DLT) rate measure: Phase II: Overall response rates (ORR) measure: Number of Adverse events of Special Interest (AESI) measure: HbA1c measure: Fasting insulin levels measure: Lipid profiles measure: Free fatty acids measure: Best overall response (BOR) measure: Duration of Response (DOR) measure: Time to Progression (TTP) measure: Progression-Free Survival (PFS) measure: Disease Control Rate (DCR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mount Sinai Health System city: New York state: New York zip: 10029 country: United States name: Adriana Rossi, MD role: CONTACT name: Katherine Vandris role: CONTACT email: Katherine.Vandris@mssm.edu name: Adriana Rossi role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
nctId: NCT06351631 id: 3543-017 id: 2023-506996-89 type: OTHER domain: EU CT id: U1111-1294-8621 type: OTHER domain: UTN id: MK-3543-017 type: OTHER domain: Merck ID briefTitle: A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017) overallStatus: NOT_YET_RECRUITING date: 2024-05-21 date: 2034-12-04 date: 2034-12-04 date: 2024-04-08 date: 2024-04-08 name: Merck Sharp & Dohme LLC class: INDUSTRY briefSummary: The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria:
No hypothesis testing will be conducted in this study. conditions: Thrombocythemia, Essential conditions: Primary Myelofibrosis conditions: Myelofibrosis conditions: Post-polycythemia Vera Myelofibrosis conditions: Post-essential Thrombocythemia Myelofibrosis conditions: Polycythemia Vera studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 400 type: ESTIMATED name: Bomedemstat measure: Percentage of participants with one or more adverse events (AEs) measure: Percentage of participants who discontinued study treatment due to an AE measure: For participants with ET or PV: Duration of clinicohematologic response measure: For participants with ET or PV: Duration of hematologic remission measure: For participants with ET or PV: Percentage of participants with transformation to MF or MDS/AML measure: For participants with MF: Percentage of participants with worsening of splenomegaly or transformation to MDS/AML measure: For participants with MF, ET, or PV: Percentage of participants with thrombotic events measure: For participants with MF, ET, or PV: Percentage of participants with major hemorrhagic events measure: For participants with MF, ET, or PV: Event-Free Survival (EFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06351618 id: 2023-06114-01 briefTitle: Epidemiology of Injuries in the Professional Women's Swedish National IceHockey League Permitted to Body-Checking overallStatus: RECRUITING date: 2023-12-01 date: 2024-03-26 date: 2028-01-01 date: 2024-04-08 date: 2024-04-08 name: Lund University class: OTHER briefSummary: This research project can contribute to a deeper understanding of injury patterns among professional female ice-hockey players allowed to body check. An understanding of common injury types and mechanisms aids the clinician in diagnosis and management. This information can guide preventative strategies in the areas of education, coaching, rule enforcement, rule modifications, equipment improvement, and sportsmanship. Today, ice hockey is a sport associated with many severe injuries that not only causes suffering and lower quality of life for the athlete, but also costs society a lot of money. Reducing the number and severity of sport-related injuries is therefore of importance. Knowledge of the injury epidemiology of women's hockey could also contribute to better preventive training programs and other injury preventive actions in the sport. Currently, only a minority of all sports medicine research is made on female study participants (26). This research project has the possibility to gain more knowledge about the female athlete, not only applicable for elite hockey-players, but also for female athletes in different disciplines and in youth teams. Knowledge of factors associated with injury could also contribute to better injury preventive actions and highlight subgroups in extra need of future preventive interventions. conditions: Sport Injury conditions: Ice-Skates Accident conditions: Sports Accident conditions: Female Athlete Triad conditions: Female studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 225 type: ESTIMATED name: No intervention will be conducted. measure: Injuries per 1000 training hours measure: Injuries per 1000 game hours sex: FEMALE minimumAge: 16 Years maximumAge: 110 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The Faculty of Medicine at Lund University status: RECRUITING city: Malmö zip: 20213 country: Sweden name: Amanda Lahti role: CONTACT phone: 0704854798 email: amanda.lahti@med.lu.se lat: 55.60587 lon: 13.00073 hasResults: False
nctId: NCT06351605 id: CSP006 briefTitle: A Registry Study to Assess Photobiomodulation in Dry Age-Related Macular Degeneration (EUROLIGHT) (EUROLIGHT) overallStatus: RECRUITING date: 2023-09-01 date: 2026-09 date: 2026-12 date: 2024-04-08 date: 2024-04-08 name: LumiThera, Inc. class: INDUSTRY briefSummary: The EUROLIGHT study is being conducted to collect real life data for the safety and effectiveness of PBM in dry AMD, in routine clinical practice both retrospectively and prospectively. conditions: Dry Age-related Macular Degeneration studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 500 type: ESTIMATED name: Valeda Light Delivery System measure: Best-Corrected Visual Acuity (BCVA) measure: OCT Imaging measure: FAF Imaging sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Oslo University Hospital status: RECRUITING city: Oslo country: Norway name: Øygunn Utheim, MD role: CONTACT phone: +47 93692578 email: outheim@gmail.com lat: 59.91273 lon: 10.74609 hasResults: False
nctId: NCT06351592 id: ALN-SOD-ALS-2351 id: 2023-510344-20-00 type: REGISTRY domain: EU CT Number briefTitle: First in Human (FIH) Study of ALN-SOD in Adult Participants With Amyotrophic Lateral Sclerosis Associated With Mutation in the SOD1 Gene (SOD1-ALS) overallStatus: NOT_YET_RECRUITING date: 2024-06-28 date: 2029-04-28 date: 2029-04-28 date: 2024-04-08 date: 2024-04-08 name: Regeneron Pharmaceuticals class: INDUSTRY briefSummary: This study is researching an experimental drug called ALN-SOD (called "study drug"). This study is focused on people with amyotrophic lateral sclerosis (ALS) who have a mutation in a gene called the superoxide dismutase-1 (SOD1) gene. This type of ALS is known as "SOD1-ALS". This is the first time that ALN-SOD will be given to people. The aim of the study is to see how safe and tolerable the study drug is.
* What effects the study drug has on ALS symptoms conditions: Amyotrophic Lateral Sclerosis (ALS) conditions: Mutation in the Superoxide Dismutase-1 (SOD1) Gene studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: No masking during Open-Label Treatment Period after 4-week Double-Blind Treatment Period. This part of the study consists of a crossover design. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: ALN-SOD name: Diluent name: Placebo (PB) measure: Incidence of treatment-emergent adverse event (TEAEs) in participants treated with ALN-SOD measure: Severity of TEAEs in participants treated with ALN-SOD measure: Concentration of SOD1 protein in cerebrospinal fluid (CSF) over time measure: Change in concentration of SOD1 protein in CSF over time measure: Concentration of neurofilament light chain (NfL) in plasma over time measure: Change in concentration of NfL in plasma over time measure: Concentration of NfL in CSF over time measure: Change in concentration of NfL in CSF over time measure: Concentration of ALN-SOD in plasma over time measure: Concentration of ALN-SOD in CSF over time measure: Incidence of anti-drug antibodies (ADAs) to ALN-SOD in serum over time measure: Titer of ADAs to ALN-SOD in serum over time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06351579 id: 1010159 briefTitle: Data Collection Post Radical Prostatectomy acronym: ALTO overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2025-12-30 date: 2026-03-15 date: 2024-04-08 date: 2024-04-08 name: Levee Medical, Inc. class: INDUSTRY name: RQMplus briefSummary: The study is to collect information on patients undergoing radical prostatectomy (RP), with a primary focus on the occurrence, duration, and severity of post-prostatectomy incontinence. Data will be collected at multiple time points, allowing for a dynamic understanding of urinary incontinence patterns at post RP. conditions: Stress Urinary Incontinence conditions: Radical Prostatectomy conditions: BPH studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Control measure: The change in average 24-hour pad weight over time measure: Change in pad weight during a 1-hour provocative pad weight test measure: Expanded Prostate Index Composite (EPIC-26) score. sex: MALE minimumAge: 45 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06351566 id: VD3, Prebiotics in Diabetes briefTitle: Effects of Vitamin D3 and Prebiotics Supplementation on Cardiovascular Risk Factors in Patients With Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-04-24 date: 2024-12-31 date: 2025-12-31 date: 2024-04-08 date: 2024-04-22 name: Huazhong University of Science and Technology class: OTHER briefSummary: The goal of this randomized, double-blind, placebo-controlled, 6-month supplementation study in individuals with type 2 diabetes is to investigate whether taking daily dietary supplements of vitamin D3 (1600 IU) or prebiotics (inulin, 10 gram) has beneficial effects on cardiovascular disease risk factors. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Vitamin D3 name: Prebiotics name: Vitamin D3 placebo name: Prebiotics placebo measure: Glycated hemoglobin (HbA1c) measure: Concentration of blood lipids measure: Metagenomic analysis of the gut microbiota measure: Concentration of fasting glucose measure: Concentration of fasting insulin measure: Systolic and diastolic blood pressure measure: Estimated glomerular filtration rate (eGFR) measure: Concentration of C-reactive protein (CRP) measure: Concentration of procalcitonin measure: Concentration of interleukin-6 (IL-6) measure: Concentration of serum 25(OH)D measure: Body weight measure: Waist circumference measure: Hip circumference sex: ALL minimumAge: 40 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06351553 id: 2023-169 briefTitle: Effect of the Autonomic Nervous System on the Outcomes of PULSEd Field Ablation to Treat Atrial Fibrillation acronym: EASy-PULSE AF overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-06 date: 2024-04-08 date: 2024-04-08 name: Hospital General Universitario de Alicante class: OTHER briefSummary: Pulmonary vein (PV) isolation is considered the therapeutic strategy of choice to maintain sinus rhythm (SR) in symptomatic patients with atrial fibrillation (AF). The most commonly used energy modality is radiofrequency (RF). However, this type of energy presents notable challenges, such as its lack of selectivity for myocardial tissue, which increases the risk of serious complications such as atrioesophageal fistula, PV stenosis, and vagus nerve injuries. In this context, PV isolation using pulsed field ablation (PFA) emerges as a promising alternative due to its greater myocardial selectivity. However, this selectivity presents additional challenges. Preliminary studies indicate that PFA may not damage the autonomic nervous system (ANS) involved in the initiation and maintenance of AF in certain patients, although stronger evidence is needed to support this claim.
The investigators propose to carry out a single-center clinical trial, although with the possibility in the future of including other centers. Patients will be randomized to three research groups: PV isolation with RF, PV isolation with PFA, and PV isolation combining PFA and RF (using RF on the anterior wall and PFA on the posterior wall). This assignment will be open to the operator who performs the procedure, but blind for the researcher responsible for monitoring and for the data analyst. The objective is to compare the impact of different energy sources during PV isolation on the ability to produce a permanent alteration in the ANS. The hypothesis is that combined PF isolation will be capable of producing a permanent alteration of autonomic function parameters superior to ablation using exclusive PFA. conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 156 type: ESTIMATED name: Pulmonary vein isolation exclusively with radiofrequency name: Pulmonary vein isolation exclusively with pulsed field ablation name: Combined pulmonary vein isolation measure: Efficacy primary outcome: Alteration of autonomic function parameters measure: Efficacy secondary outcome: Alteration of autonomic function parameters measure: Efficacy secondary outcome: Alteration of autonomic function parameters measure: Efficacy secondary outcome: Alteration of autonomic function parameters measure: Efficacy secondary outcome: Procedure duration. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Laura García Cano city: Alicante zip: 03010 country: Spain lat: 38.34517 lon: -0.48149 hasResults: False