hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06309303 id: RC 12/20 briefTitle: Kawasaki Disease During the COVID-19 Epidemic acronym: KAWACOVID overallStatus: COMPLETED date: 2020-07-01 date: 2023-12-31 date: 2023-12-31 date: 2024-03-13 date: 2024-03-13 name: IRCCS Burlo Garofolo class: OTHER briefSummary: Northern Italy is the second region hit by the SARS-COV2 infection worldwide. Data on COVID-19 clinical presentation in children is still scarce, but fewer rate of infection and milder disease seem typical of this age group. In the last three weeks it has been reported an abnormal number of critically ill patients with clinical characteristics consistent with Kawasaki Shock Syndrome (KSS). The common manifestations are: "middle aged" children (6-9 y/o) with a history of persistent high spiking fever in the last days, abdominal pain, diarrhea, skin rash and rapidly deteriorating clinical condition with the onset of shock, without clear signs of dehydration. Other less common features are arthralgia, cough, meningism, conjunctivitis and reddened, cracked lips. Labworks usually show high inflammatory markers, low lymphocyte counts, low sodium, and high troponin levels. Echocardiography have been consistent with myocarditis in the majority of patient instead of classical coronary artery abnormalities. Patients have been diagnosed as Kawasaki disease (typical or incomplete) and treated accordingly with IntraVenous ImmunoGlobulin (IVIG) and/or steroids. One patient refractory to such treatments responded successfully to intravenous Anakinra. All the patients reported a family history consistent with COVID-19, serology and naso-pharyngeal swabs were inconsistently positive. To date we are aware of at least 10 such cases. KSS is a rare and dreadful complication, with an estimated prevalence of 5% of patients with Kawasaki Disease (KD). Given the extreme rarity of this condition, the occurrence of so many cases in the last weeks points to a possible causative agent. As our hospitals are in high endemic area, SARS-COV2 seems the most obvious, although testing for such infection in patients returned conflicting results. It is not clear, at this moment, if this clinical entity is a proper KD triggered by SARS-COV2, or a systemic vasculitis with similar features of KD, secondary to SARS-COV2 infection. The aim of this nationwide study is to better define this clinical entity. conditions: Kawasaki Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 25 type: ACTUAL name: Clinical evaluation measure: Number of subjects with Kawasaki Disease and concomitant SARS-COV-2 infection measure: Number of subjects with Kawasaki Disease without concomitant SARS-COV-2 infection sex: ALL minimumAge: 1 Month maximumAge: 18 Months stdAges: CHILD facility: IRCCS Burlo Garofolo city: Trieste zip: 34137 country: Italy lat: 45.64953 lon: 13.77679 hasResults: False
nctId: NCT06309290 id: FAPESP-UFRO briefTitle: Prehabilitation With Resistance-exercise Training for Breast Cancer Neoadjuvant Therapy acronym: PRE-RET overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08 date: 2025-01 date: 2024-03-13 date: 2024-03-15 name: Universidad de La Frontera class: OTHER briefSummary: Breast cancer stands as the foremost cause of cancer-related deaths among women worldwide, with the highest incidence of any cancer type. The choice of therapeutic interventions hinges upon factors like cancer stage, cell subtype, and tumor size. Consequently, individuals with more aggressive tumors, such as HER+2 and Triple Negative, or larger tumors often undergo neoadjuvant chemotherapy before breast surgery. However, these anticancer treatments come with side effects like cancer-related fatigue, reduced functional capacity, and changes in body composition, notably skeletal muscle atrophy. Skeletal muscle loss correlates with heightened mortality rates, cardiotoxicity, and diminished quality of life, underscoring the need for early therapeutic interventions. One such promising strategy is prehabilitation, which involves resistance-exercise training aimed at bolstering skeletal muscle mass from the outset of the disease, even preceding breast surgery. Resistance-exercise training has shown favorable effects on women undergoing adjuvant therapy or survivors of breast cancer, however, its molecular and clinical effects in women with breast cancer undergoing neoadjuvant therapy are unknown. conditions: Prehabilitation conditions: Breast Cancer conditions: Postmenopause conditions: Resistance Training studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Prehabilitation with resistance-exercise training name: Usual care program measure: Change in skeletal muscle mass (measured via Computed tomography (CT) scan) measure: Change in arms and legs strength (measured via 1-Repetition Maximum (1RM) testing) measure: Change in hand grip strength (measured via JAMAR handheld dynamometer) measure: Change in physical performance measured via Short physical performance battery measure: Change in points quality of life measured via questionnaire European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) measure: Change in points Brief fatigue inventory (BFI) measure: Change in microgram per milliliter (µg/ml) of Human Insulin via ELISA measure: Change in pathological complete response rate measure: Change quantification proteins sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fundación Arturo López Pérez city: Santiago country: Chile lat: -33.45694 lon: -70.64827 facility: Department of Rehabilitation Sciences, Faculty of Medicine, Universidad de La Frontera. Temuco, Chile city: Temuco country: Chile lat: -38.73965 lon: -72.59842 hasResults: False
nctId: NCT06309277 id: GLG-100X briefTitle: A Clinical Study to Evaluate of Single and Multiple Oral Doses of GM-1020 in Patients With MDD overallStatus: RECRUITING date: 2024-02-01 date: 2024-07 date: 2024-07 date: 2024-03-13 date: 2024-04-04 name: Gilgamesh Pharmaceuticals class: INDUSTRY briefSummary: The aim of this Phase 2a study in patients with MDD is to assess safety and tolerability and preliminary antidepressant efficacy. conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: GM-1020 measure: Incidence of treatment emergent adverse events measure: Montgomery-Åsberg Depression Rating Scale (MADRS) Change from baseline to 72 hours sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MAC Clinical Research status: RECRUITING city: Manchester country: United Kingdom name: Gregory role: CONTACT lat: 53.48095 lon: -2.23743 hasResults: False
nctId: NCT06309264 id: C5059-R id: I01RX005059 type: NIH link: https://reporter.nih.gov/quickSearch/I01RX005059 briefTitle: Comparing Hearing Aid Fitting Methods in Blast-exposed Veterans acronym: SBA overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-03-31 date: 2028-03-31 date: 2024-03-13 date: 2024-03-13 name: VA Office of Research and Development class: FED name: University of California, San Diego name: NADI Inc. briefSummary: Since 2000, at least 250,000 U.S. Service members have experienced a blast-related mild traumatic brain injury. A retrospective analysis of over 100,000 post-9/11 Veterans shows that blast injury more than doubles the risk of a diagnosed auditory problem. Many blast-exposed Veterans experience "functional hearing difficulties" (FHDs): problems in challenging listening environments despite clinically normal hearing as measured by the pure-tone audiogram. VA audiologists have begun using low-gain hearing aids to treat FHDs, but there are no concrete guidelines for this application given standard procedures rely on the pure-tone audiogram. This study proposes a data-driven approach called speech-based audiometry (SBA), which optimizes hearing aid gains from a patient's responses to speech stimuli in aided conditions. This trial will assess the behavioral (speech recognition in noise, subjective listening difficulty) and neurophysiological (functional neuroimaging during a speech recognition task) benefits of low-gain hearing aids programmed conventionally or with SBA among blast-exposed Veterans with FHDs. conditions: Auditory Diseases, Central studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: This study is a 2x2 randomized trial. Each subject receives a low-gain hearing aid. The randomized factors are:
The factors are fully crossed such that there are four groups in the experiment. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Factor 1 is single blind: Participants will not know which procedure is used to program their hearing aid, but the investigator/outcomes assessor will. Factor 2 is unblinded: Participants will know whether they are assigned to the daily hearing aid use group. whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Phonak Lumina P90 measure: Change in Modified Quick Speech-in-Noise Test (mQuickSIN) Score at 6 weeks measure: Abbreviated Profile of Hearing Aid Benefit (APHAB) measure: Change in Digits in Noise Test (DIN) Score at Weekly Intervals from Baseline to 6 weeks measure: Change in fMRI Activation at 6 weeks sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: VA Loma Linda Healthcare System, Loma Linda, CA city: Loma Linda state: California zip: 92357-1000 country: United States name: Maria I Rodriguez role: CONTACT phone: 909-583-6050 email: maria.Rodriguez9@va.gov name: Ernest M Alva role: CONTACT phone: (909) 825-7084 phoneExt: 1500 email: ernest.alva@va.gov name: Jonathan Venezia, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.04835 lon: -117.26115 facility: VA Greater Los Angeles Healthcare System, Sepulveda, CA city: Sepulveda state: California zip: 91343 country: United States name: Delia Karahalios, AuD role: CONTACT phone: 818-891-7711 phoneExt: 32752 email: delia.karahalios@va.gov name: Jamie Spector, AuD role: CONTACT phone: 8188917711 phoneExt: 7062 email: jamie.spector@va.gov lat: 34.16167 lon: -118.28285 facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA city: West Los Angeles state: California zip: 90073-1003 country: United States name: Delia Karahalios, AuD role: CONTACT phone: 818-891-7711 phoneExt: 32752 email: delia.karahalios@va.gov name: Guneet Missan, AuD role: CONTACT phone: 3104783711 phoneExt: 40613 email: guneet.missan@va.gov lat: 34.0464 lon: -118.44813 hasResults: False
nctId: NCT06309251 id: KetoSTrENgTH briefTitle: Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients overallStatus: RECRUITING date: 2022-03-01 date: 2025-05-31 date: 2026-05-31 date: 2024-03-13 date: 2024-03-13 name: Danone Nutricia SpA Società Benefit class: INDUSTRY briefSummary: The goal of this observational study is to learn about the clinical and nutritional effectiveness of ketogenic diet (KD) in pediatric patients with genetic, neurological or metabolic conditions requiring KD.
* how does KD impact quality of life? Participants will be followed up as per clinical practice conditions: Drug Resistant Epilepsy conditions: Autism Spectrum Disorder conditions: Chronic Migraine conditions: Brain Tumor, Pediatric studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: ketogenic diet (as per clinical practice) measure: Nutritional adequacy measure: Nutritional adequacy measure: % of responders to KD measure: Health related quality of life improvement through parent questionnaire sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: ASST Fatebenefratelli Sacco (PO "V. Buzzi") status: RECRUITING city: Milan state: MI zip: 20154 country: Italy name: Sara Olivotto, MD role: CONTACT email: sara.olivotto@asst-fbf-sacco.it name: Roberto Previtali, MD role: CONTACT email: roberto.previtali@unimi.it lat: 45.46427 lon: 9.18951 facility: Fondazione "Istituto Neurologico Nazionale C. Mondino" status: RECRUITING city: Pavia state: PV zip: 27100 country: Italy name: Valentina De Giorgis, MD role: CONTACT email: valentina.degiorgis@mondino.it name: Carlo Alberto Quaranta, MD role: CONTACT email: carloalberto.quaranta01@universitadipavia.it lat: 45.19205 lon: 9.15917 facility: Ospedale Pediatrico Bambino Gesù status: RECRUITING city: Roma state: RM zip: 00165 country: Italy name: Antonella Diamanti, MD role: CONTACT email: antonella.diamanti@opbg.net lat: 41.89193 lon: 12.51133 hasResults: False
nctId: NCT06309238 id: LightBAR briefTitle: Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial acronym: LightBAR overallStatus: RECRUITING date: 2024-04 date: 2027-12 date: 2048-12 date: 2024-03-13 date: 2024-04-25 name: Carsten Dirksen class: OTHER name: University of Copenhagen name: University of Southern Denmark name: University of Oxford name: University of Bristol name: Copenhagen Trial Unit, Center for Clinical Intervention Research briefSummary: With this trial, the aim is to assess the benefits and harms of a non-surgical intensive weight loss intervention that includes total dietary replacements, behavioural support and weight-loss medication compared with bariatric surgery for people with severe and complex obesity. The interpretation of the results will help inform future care pathways for people with obesity in whom bariatric surgery is currently the only available effective treatment option. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Due to the nature of the interventions, it will not be possible to blind the participants or the healthcare providers administering the interventions.
nctId: NCT06309225 id: BMDA-2301 briefTitle: Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly acronym: (DACHOC-E) overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2026-03-01 date: 2026-06-01 date: 2024-03-13 date: 2024-03-13 name: Omar Mahmoud class: OTHER briefSummary: Previous studies of this type of head and necl cancer have shown high rates of cancer control but result in many short and long term side effects when treated with high dose radiation and chemotherapy. Recently, investigators have noticed similar high rates of cancer control in small numbers of patients who receive less intensive treatments using lower doses of radiation, smaller radiation fields with chemotherapy. It is expected that the side effects of treatment with lower doses of radiation would be less.
The purpose of this study is to compare any good and bad effects of using lower dose smaller fields radiation therapy and chemotherapy with published outcomes. This study will allow the researchers to know whether these different approaches are better, the same, or worse than the usual approach. To be better, the study approach should result in the same survival rate of the usual approach (about 85 out of 100 patients alive and free of cancer at 2 years) but with less long-term side effects. conditions: Oropharynx Cancer conditions: Frailty studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Modified dose and fields intensity modulated radiotherapy measure: Two-year progression free survival measure: Benefit and Tolerance of Treatment measure: Acute Toxicity measure: Late toxicity measure: Failure pattern sex: ALL minimumAge: 65 Years maximumAge: 99 Years stdAges: OLDER_ADULT hasResults: False
nctId: NCT06309212 id: 2023-20/687 briefTitle: Assessing the Impact of COVID-19 on HMPV Incidence and Severity Among Adults overallStatus: COMPLETED date: 2023-12-15 date: 2023-12-30 date: 2024-01-30 date: 2024-03-13 date: 2024-03-13 name: Acibadem University class: OTHER briefSummary: Human metapneumovirus (HMPV) is primarily recognized as a childhood pathogen, but its impact on adults remains largely underestimated. This study investigates the prevalence, clinical characteristics, and post-COVID-19 trends of HMPV infection among adults in Istanbul, Turkey. conditions: The Prevalance of HMPV After COVID-19 Pandemic conditions: The Importance of Accurate Diagnosis for HPMV studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2197 type: ACTUAL name: Observation measure: Prevalence of HMPV infection in adults pre- and post-COVID-19 pandemic measure: Comparison of HMPV with other respiratory viruses in adults sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Acibadem University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
nctId: NCT06309199 id: 0855/66 briefTitle: Prevalence of FGIDs and Probiotics Study acronym: PROOF overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-02 date: 2026-02 date: 2024-03-13 date: 2024-03-13 name: Chulalongkorn University class: OTHER briefSummary: This is a study to evaluate the prevalence of FGIDs in infants using the Thai version of Rome IV diagnostic questionnaire for functional gastrointestinal disorders in infants and evaluate the efficacy of Limosilactobacillus reuteri DSM 17938 to prevent FGIDs in infants. conditions: Functional Gastrointestinal Disorders conditions: Infant Conditions studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention group received probiotics Control group received sunflower and MCT oil primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: These 2 groups was assigned using computer generate with block of 4 and ratio 1:1.
The intervention and placebo were prepare in the same container with the same color, odor and blinded to investigators, participants and guardians. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 512 type: ESTIMATED name: Biogaia name: Placebo measure: The prevalence of functional gastrointestinal disorders in the treatment group measure: The prevalence of functional gastrointestinal disorders in the placebo group measure: Nutrition associated with functional gastrointestinal disorders in infants measure: Gut microbial profiles associated with functional gastrointestinal disorder in infants measure: The sleep quality assessed by Brief Infant Sleep Revise Questionnaire of BISQR measure: Stool metabolomic substances (i.e microbial conjugation of secondary bile acid, aminoacid) and the stool metabolites alteration measure: Fluid intake associated with functional gastrointestinal disorders in infants measure: Stress associated with functional gastrointestinal disorders in infants measure: Antibiotics associated with functional gastrointestinal disorders in infants measure: Economic status associated with functional gastrointestinal disorders in infants measure: Education of caregiver associated with functional gastrointestinal disorders in infants sex: ALL minimumAge: 3 Days maximumAge: 1 Year stdAges: CHILD hasResults: False
nctId: NCT06309186 id: RC 30/2023 briefTitle: Empowerment and Burnout of Midwives at the End of Health Emergency From COVID-19 overallStatus: RECRUITING date: 2023-01-09 date: 2024-12-31 date: 2024-12-31 date: 2024-03-13 date: 2024-03-18 name: IRCCS Burlo Garofolo class: OTHER briefSummary: As the fifth wave of COVID-19 comes to an end and the pandemic's countermeasures expire, there is a need to assess the impact of the pandemic on health care providers, especially midwives, as the professionals deputed to promote and protect women's holistic health, in all phases, physiological and otherwise, of the life cycle. The midwife considers the person as a whole, in which the mind-body-culture components interact profoundly. Prevention and containment measures have impacted on midwifery clinical and nursing practices with the mandatory continuous use of personal protective equipments (PPE) and social distancing to protect the patient and the practitioner, effectively hindering the intimacy of the woman-midwife relationship. The impact assessment focuses on two dimensions: learning, investigated as perceived empowerment, and perceived malaise, investigated as burnout. Empowerment has a positive connotation, which can offset burnout, a syndrome that affects the physical, psychological and emotional health of midwives and can have significant negative implications on midwife turnover, patient safety and outcomes, and the efficiency of healthcare organisations. conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 64 type: ESTIMATED name: Evaluation of midwifes' burnout measure: Evaluation of empowerment of midwives measure: Number of midwives affected by burnout sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" status: RECRUITING city: Trieste zip: 34137 country: Italy name: Martina Debelli role: CONTACT email: martina.debelli@burlo.trieste.it lat: 45.64953 lon: 13.77679 hasResults: False
nctId: NCT06309173 id: 0000-00000; ko23Hemkens briefTitle: Development of Digital Biomarkers in Multiple Sclerosis: Validation Study 2 acronym: DreaMS_VS2 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-12 date: 2026-12 date: 2024-03-13 date: 2024-03-20 name: University Hospital, Basel, Switzerland class: OTHER briefSummary: Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS). Diagnosis is established by clinical assessment of persons with MS (PwMS), in combination with imaging and body fluid assessments. Treatment decisions in MS are mainly based on periodic monitoring of disease activity and progression through clinical and imaging assessments.
This international, observational study aims to evaluate and validate the generalizability of these DB across different languages and cultural settings to provide DB that are helpful for patient care, research, and regulatory decisions. Beyond this, the processes and data structures created for this study are intended to establish a collaborative research platform for subsequent studies, including pragmatic trials, promoting new long-term international academic collaborations. conditions: Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED measure: Correlation of the digital features with the respective measurements of the clinical reference tests measure: The ability of measurements of the changes in the digital biomarkers over the two-year follow-up to predict worsening in the clinical reference test over the same period expressed as binary variables measure: The ability of the digital biomarker to detect worsening in other relevant reference test results creating converging evidence measure: The ability of the digital biomarker to detect worsening in standard assessments used for treatment of PwMS (clinical, imaging, body fluids) measure: The ability of the digital biomarker to detect change of Patient Reported Outcomes measure: The ability of the digital biomarker to detect occurrence of clinical and other meaningful events (relapses, PIRA, serious adverse events, hospitalizations, working capacity) measure: The relationship of the digital biomarkers with imaging and body fluid markers measure: The relationship of the digital biomarkers with Patient Reported Outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False