Kornimate/medical-research-clean huggingface dataset:
a pilot study of oxaloacetate in subjects with treated pd

Conditions: Parkinson's Disease

Summary: the purpose of this study is to determine if oxaloacetate (oaa) is a safe and effective treatment for parkinson's disease. each subject will be asked to make 3 study visits and complete two safety follow-up phone calls over a 4 month period.


Eligibility criteria:
inclusion criteria: * able to give informed consent and follow instructions per the protocol * diagnosis of idiopathic pd within 7 years of diagnosis * taking stable doses of levodopa and would not predictably need adjustment in pd medications for 4 months * unified parkinson's disease rating scale (updrs) ii + iii at least 30 points at baseline exclusion criteria: * previously taken oxaloacetate * participation in other drug studies or use of other investigational products within 30 days prior to baseline * in the investigator's opinion, any unstable or clinically significant condition that would impair the subjects' ability to comply with study follow-up * other known or suspected cause of parkinsonism
pre-operative hypofractionated proton therapy

Conditions: Soft Tissue Sarcoma

Summary: this study is being done to examine whether proton therapy for certain kinds of sarcomas (extremity and trunk soft tissue) is safe and effective. as part of the study, patients will have five fractions of proton therapy before the participants have surgery for the sarcoma. the study will measure wound complications and functional outcomes / quality of life after the procedures. patients will be asked to complete questionnaires about the treatment and quality of life from the time of enrollment until about two years after surgery. otherwise, the participants will have standard of care follow ups with the treatment team.


Eligibility criteria:
inclusion criteria: * adult patients (≥18 years of age) * patients with primary or locally recurrent extremity or truncal soft tissue sarcoma * who/ecog status ≤2 exclusion criteria: * history of prior local radiation therapy * inability to tolerate treatment position for duration of simulation or treatment * tumor originating in retroperitoneal location * patients planned for systemic therapy including chemotherapy, targeted agents, and immunotherapy * co-existing malignancy or treated malignancy in the last 2 years expected to limit life expectancy; does not include completely resected cutaneous basal cell carcinoma, squamous cell carcinoma, in situ breast or cervical malignancies, or other pathologies at the discretion of the investigators. * confirmed pregnancy.

Keywords: proton therapy soft tissue sarcoma hypofractionated
assessment of dot spectacles in chinese children extension

Conditions: Juvenile Myopia; Myopia

Summary: this is a randomized, controlled, open-label, evaluator-blinded, multicenter, clinical trial of 12-months duration to evaluate the continued safety and efficacy of diffusion optics technology (dot) spectacle lenses in reducing the progression of juvenile myopia in children of chinese origin.


Eligibility criteria:
inclusion criteria: 1. previously a successfully completed participant in the cathay study (nct05562622) 2. agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day) 3. willingness to participate in the trial for 12 months without contact lens wear or any other myopia management intervention 4. the subject's parent(s) or legal guardian(s) must read, understand and sign the statement of informed consent and receive a fully executed copy of the form exclusion criteria: 1. known allergy to proparacaine, tetracaine, or tropicamide or cyclopentolate
adherence to guidelines vaccination in type 1 diabetes mellitus patients (avadi-2)

Conditions: Type 1 Diabetes

Summary: observational study about adherence to guidelines for covid-19, influenza, pneumococcal and hepatitis b vaccination in adult patients with type 1 diabetes mellitus.

cross-sectional analysis about adherence to guidelines for covid-19, influenza, pneumococcal and hepatitis b vaccination in adult patients with type 1 diabetes mellitus. all clinical variables are gathered from two emr softwares (mambrino xxi and turriano). data analysis is conducted using spss (chicago, il) statistics software. results are presented as mean ± sd values or percentages. a paired student's t-test or a wilcoxon signed-rank test were used for the analysis of differences. comparisons between proportions were analyzed using a chi-squared test. a p value \< 0.05 was considered statistically significant. the protocol was approved by the reference castilla-la mancha public health institute ethic committee. all participants provided written informed consent.

Eligibility criteria:
inclusion criteria: * type 1 diabetes * age: 18 yrs. or older exclusion criteria: * other diabetes types. * younger than 18 years.
xarelto on prevention of stroke and non-central nervous systemic embolism in renally impaired korean patients with non-valvular atrial fibrillation

Conditions: Non-valvular Atrial Fibrillation (NVAF)

Summary: the purpose of the study is to evaluate the safety and effectiveness of xarelto in renally impaired patients with nvaf under routine practice conditions. the information collected in the xarenal study will help to understand how renally impared patients with nvaf are treated in the real-world setting and what the outcome for the patients is under those conditions.


Eligibility criteria:
inclusion criteria: * female and male patients ≥ 19 years of age * diagnosis of nvaf * patients for whom the decision to initiate treatment with rivaroxaban has already been made as per physician's routine treatment practice * previous documented creatinine clearance rate of 15-49ml/min within 6 months before enrollment * written informed consent of the patient exclusion criteria: * contraindications for rivaroxaban according to the current korean market authorization and summary of product characteristics (smpc). * patients participating in an investigational program with interventions outside of routine clinical practice. * planned treatment with other anticoagulants. * expected renal-replacement therapy within the next 3 months

Keywords: non-valvular atrial fibrillation (nvaf), stroke; non-central nervous systemic (cns) embolism
large-scale multi-omics analysis of cerebrospinal fluid

Conditions: Aging

Summary: the aim of this study is to explore the role of cerebrospinal fluid (csf) biomarkers in aging and neurodegenerative diseases.

this study aims to investigate the role of cerebrospinal fluid (csf) biomarkers in aging and neurodegenerative diseases, with a focus on the following objectives: analysis of age-related changes in csf biomarkers: the study will analyze csf samples from different age groups to identify biomarkers that undergo significant changes during the aging process. this includes the investigation of amyloid-beta (aβ42), tau proteins (including the phosphorylated form p-tau181), and other proteins related to neuroinflammation and blood-brain barrier function. development of a predictive model for early diagnosis: by categorizing and quantifying csf proteins across various age groups, the study aims to establish a predictive model for the early diagnosis of neurodegenerative diseases, such as alzheimer's disease. the ability to detect these diseases before clinical symptoms emerge could enable early intervention and treatment, offering a crucial window for therapeutic strategies. investigation of dynamic changes in csf biomarkers across disease stages: the study will examine the dynamic changes in csf biomarkers at different stages of neurodegenerative diseases, including early, middle, and late stages. understanding the role of these biomarkers in disease progression will provide insights into the pathological processes and potential therapeutic windows. creation of a comprehensive csf biomarker database: a database will be established, encompassing csf biomarkers from various age groups, disease states, and treatment responses. this resource will be invaluable for future research, facilitating the scientific community's understanding of neurodegenerative diseases and the development of new therapeutic approaches. through the achievement of these objectives, this study aims to advance the application of csf biomarkers in neuroscience research and clinical practice, ultimately improving the diagnosis, management, and treatment of aging-related and neurodegenerative conditions.

Eligibility criteria:
1. inclusion criteria: * patients aged 0 to 90 years will be selected for the study. * patients admitted for surgery under spinal anesthesia due to non-neurological conditions, such as lower limb fractures or hemorrhoids. * pediatric patients undergoing surgical treatment for tethered spinal cord syndrome. 2. exclusion criteria: * patients with neurological conditions, including encephalitis, parkinson's disease, alzheimer's disease, hydrocephalus, brain tumors, and psychiatric disorders.

Keywords: biomarker aging neurodegenerative disease
screening cardiovascular patients for aortic aneurysms (scan)

Conditions: Abdominal Aortic Aneurysm; AAA

Summary: the aim of the cohort study scan (screening cardiovascular patients for aortic aneurysms) is to establish a screening programm for patients with a high risk for an aaa. aortic aneurysms in these patients should be identified at an early stage and thereby aaa-associated mortality be decreased.

a recently published meta-analysis showed a higher prevalence of aortic aneurysm (aaa) in men requiring treatment of coronary heart disaese compared to standard population. in women, however, the prevalence was not increased. thus, the scan project addresses male patients who underwent coronary artery intervention in order to screen them for the presence of an aaa using duplex sonography. the scan project involves the following elements: 1. informing the patient with cardiovascular risk factors about the clinical picture of aaa 2. an ultrasound scan of the abdominal aorta in patients with an increased risk for aaa 3. acquisition of patient data followed by a correlation analysis for the parameters presence of aaa and cardiovascular diseases the cohort study is part of the scan project which is also conducted in an similar way by catharina ziekenhuis eindhoven clinicaltrials.gov identifier:nct01643317.

Eligibility criteria:
inclusion criteria: * men with coronary artery intervention (ptca/stenting) * at least 1 risk factor for aaa (hypertension, hyperlipidaemia, hyperuricemia, nicotine abuse,positive family history) exclusion criteria: * life expectancy less than 1 year * inability to follow the instructions of the investigator (dementia, lack of time, insufficient understanding of the language) * insufficient compliance

Keywords: abdominal aortic aneurysm aaa screening
caring for the caregiver network

Conditions: Caregivers of Alzheimer's Disease or Memory Problem Patients

Summary: the prevalence of family caregivers is projected to increase in concert with the projected increase in number of ad patients. the focus of the study is to gather systematic data on the acceptability and efficacy of a unique technology-based, culturally- tailored psycho-social intervention program that targets ethnically/culturally diverse family caregivers of patients with alzheimer's disease. the overall goal of the project is to improve the lives of family caregivers as well as their ability to provide care to their loved one and to reduce disparities in access to needed services and support among caregiver populations.


Eligibility criteria:
inclusion criteria: 1. speak and understand english or spanish 2. provide care to a loved one with memory decline 3. not having terminal illness/condition 4. 18+ yrs old exclusion criteria: 1. not providing care to a loved one with alzheimer disease or dementia 2. not speak english or spanish 3. have cognitive deficit 4. have terminal illness 5. plan to place their loved one in a facility 6. plan to move away in the next 12 months

Keywords: alzheimer's caregivers technology-based intervention culturally-tailored intervention
study to test the efficacy of periarticular levo bupivicaine injection following primary hip arthroplasty

Conditions: Osteoarthritis

Summary: the hypothesis of this study is that isolated use of local periarticular levobupivicaine injection during primary hip arthroplasty would improve post-operative pain control. patients were randomised in the operating room to receive either a periarticular infiltration, or a placebo consisting of saline. morphine and analgesic consumption was recorded for each patient, while the modified mcgill pain scale was used to determine the adequacy of analgesia and the benefit of the peri-articular infiltration. 91 patients were recruited, with 45 patients in the treatment group and 46 controls. the results were assessed after one year, once all the information from both treatment groups was collected.

the efficacy of periarticular injections during total knee arthroplasty is well established but there is little published data on their effect in primary hip arthroplasty. we hypothesized that isolated use of local periarticular levobupivicaine injection during primary hip arthroplasty would improve post-operative pain control. a double blinded, randomised, placebo-controlled trial on patients undergoing primary hip arthroplasty was performed. patients were randomised in theatre to receive either a periarticular infiltration of 150mg levobupivicaine in 60mls of 0.9% saline, or a placebo consisting of 60mls 0.9% saline. morphine and analgesic consumption was recorded for each patient, while the modified mcgill pain scale was used to determine the adequacy of analgesia and the benefit of the peri-articular infiltration. 91 patients were recruited, with 45 patients in the treatment group and 46 controls. the results were assessed after one year, once all the information from both treatment groups was collected.

Eligibility criteria:
inclusion criteria: * consecutive patients undergoing primary hip arthroplasty for osteoarthritis only were included in this study after giving informed consent. exclusion criteria: * patients with cognitive impairment, neurological disorders, advanced liver or renal impairment, known ischemic heart disease, a previous diagnosis of a pain syndrome or any post-operative surgical or medical complications were excluded.

Keywords: total hip arthroplasty periarticular injection pain
symptoms of post-traumatic stress in adult drug-resistant epilepsies

Conditions: Epilepsy

Summary: epilepsy is a neurological disease that can cause many comorbid psychiatric disorders, among them: generalized anxiety disorder and depression. many studies suggest a temporal relationship between exposure to a traumatic event and the development of epilepsy. the objective of this research is to study the symptoms of post-traumatic stress disorder (pts) in patients with epilepsy, and their relation to anxiety and depression in these patients. the investigators also wish to study how such symptoms may be associated with the subjective semiological manifestations of epileptic seizures. in addition, it has been shown that patients with epilepsy are able, from the identification of different warning signs, to anticipate their vulnerability to having an epileptic seizure allowing them to set up different types. strategies to control them. the investigators also wish to study the cognitive processes involved in this control and the influence of pts symptoms, in particular hypervigilance on this behavior. the investigators propose a protocol using different types of measures: emotional, cognitive and physiological in order to answer our questions. in addition to patients with epilepsy, two groups of patients will be included: a group of patients with another chronic non-neurological disease to compare the prevalence of pts symptoms and a group of patients with post-traumatic stress disorder ( ptsd) to compare with patients with epilepsy, cognitive and physiological measures. finally, the results of this study should allow to develop tools for assessing pts symptoms in epilepsy and to develop specific management approaches


Eligibility criteria:
inclusion criteria: * man or woman between 18 and 50 years old; * native french speaker; * level of education higher than the 3rd school level; * certain diagnosis of the pathology of the experimental group with which he will be associated, more precisely: * group of patients with epilepsy \[group e\]: definite diagnosis of drug-resistant epilepsy (epileptic seizures persist despite the administration of daily treatment) established by a specialist physician. * group of patients with a heart rhythm disorder \[group c\]: definite diagnosis of one of the following disorders: atrial fibrillation (af); syncope and bouveret's disease established by a specialist. * group of patients with t1 diabetes mellitus \[group d\]: definite diagnosis of type 1 diabetes established by a specialist doctor. * group of patients with ptsd \[group t\]: definite diagnosis of ptsd established by a specialist doctor. * person having given his non-objection exclusion criteria: * pregnancy; * breastfeeding women; * severe cognitive impairment * addiction to alcohol or drugs (including drugs other than those related to epilepsy or the chronic disease from which the patient has); * other neurological and / or psychiatric disorders than cnep or epilepsy except anxiety and depressive disorders; * adults under guardianship or under judicial protection * people deprived of their liberty * inability to read french.
european real-world experience of previously treated advanced/metastatic her2-positive breast cancer patients accessing trastuzumab deruxtecan

Conditions: HER2-positive Breast Cancer

Summary: a named patient program (npp) was initiated to allow patients with an unmet medical need to access trastuzumab deruxtecan (t-dxd) treatment. to gain early insights on the use of t-dxd outside of a trial setting, patients with advanced/metastatic her2+ breast cancer receiving treatment (or previously treated) with t-dxd through the npp will be invited to participate.

the antibody-drug conjugate t-dxd has been granted conditional approval in the european union as a single agent for adult patients with unresectable or metastatic her2+ breast cancer who have previously received ≥2 her2-based regimens. this was based on data from the phase ii destiny-breast01 trial (nct03248492). ds8201-0002-eap-ma is a real world data (rwd) observational data collection inviting patients with advanced/metastatic her2+ breast cancer receiving t-dxd through the npp already to participate to help further understand the usage in a real world clinical setting.

Eligibility criteria:
inclusion criteria: * participants for whom t-dxd treatment is indicated, according to the summary of product characteristics conditionally approved by the ema, that are eligible for treatment with t-dxd through the npp (i.e., those with advanced/metastatic her2+ breast cancer who have received ≥ 2 prior anti-her2-based regimens and have documentation of her2 positive tumour status by a validated method) will be eligible for inclusion to this rwd collection, subject to providing written informed consent to participate. exclusion criteria: * any participant who does not meet all inclusion criteria noted above.

Keywords: her2-positive breast cancer trastuzumab deruxtecan
perioperative fluid management: goal-directed versus restrictive strategy

Conditions: Complication, Postoperative

Summary: there is no ideal "cookbook recipe" for fluid prescription that would fit every surgical patient. in this study, the investigators working hypothesis is that the adoption of an integrative algorithm for perioperative fluid and haemodynamic management would improve clinical outcome and reduce hospital resource utilization in noncardiac surgical procedures (major-to-intermediate level of stress. two intraoperative fluid strategies will be compared: "restrictive" vs. "goal-directed therapy (gdt)". in the gdt group, haemodynamic information will be obtained by a flow monitoring device coupled with standard heart rate and blood pressure monitoring.

the rationale of minimizing body weight gain and avoiding unnecessary fluid compensation of the "third compartment" is now well justified and achievement of supra-normal oxygen delivery values is likely not necessary in most surgical patients. therefore,it would be tempting to adopt fluid restriction protocols given the potentials of better wound healing, faster return of bowel function and shorter hospital stay after major surgical procedures. although dynamic flow indices of volume responsiveness have been validated in critically-ill patients, concerns have been raised regarding the risk of overzealous fluid administration in non-critically-ill patients undergoing elective surgery. to date, rcts comparing fluid regimen ("liberal" versus "restrictive" or "liberal" versus "gdt") have yielded controversial results with no consensus regarding appropriate fluid administration in the perioperative period. interestingly, restrictive protocols have been associated with more frequent adverse events (e.g., nausea, vomiting) following minor surgical procedures and concerns have been raised regarding the possibility of tissue hypoperfusion leading to end-organ dysfunction.

Eligibility criteria:
inclusion criteria: * adult patient * elective noncardiac surgery (moderate-high-risk) lasting \> 2h hours (, gastrectomy, pancreatectomy, nephrectomy, radical cystectomy, hepatic resection, open colonic or rectal surgery) exclusion criteria: * end-stage organ failure (hemofiltration/dialysis; child-pugh class c or meld score \>22; predicted forced expiratory volume \< 30%, severe heart failure) * life expectancy \< 24h * psychiatric disorders or unability to give independent consent to the study

Keywords: operative mortality myocardial infarct, arrhythmia, heart failure, stroke pneumonia, atelectasis, acute lung injury surgical site infection acute kidney injury body weight
measuring normal and impaired walking in children using the gaitrite walkway

Conditions: Typically Developing Children; Talipes Equino Varus; Paediatric Orthopaedic; Paediatric Neurological

Summary: walking measurement in children is important but there are challenges associated with obtaining reliable repeatable data in a clinical setting that is meaningful and easy to interpret. this study set out to develop a new way to collect, record, and interpret walking data that is suitable for the clinical environment. developmental percentile charts were selected as they are widely recognised and easily interpreted.

the primary output of the main cohort of typically developing children is the developmental percentile charts. these will be then used to present the clinical longitudinal data against a normal backdrop of developmental changes in children. this has multiple clinical applications in many of the children assessed by physiotherapy at gosh and more widely nationally and internationally

Eligibility criteria:
inclusion criteria: * able to walk 100m exclusion criteria: * recent fracture or musculoskeletal injury which would affect gait