Kornimate/medical-research-clean huggingface dataset:
advance care planning impact on the consistency of older adults with lung cancer and their potential surrogates regarding life-sustaining treatment preferences

Conditions: Advanced Care Planning (ACP); ELDERLY PEOPLE; Lung Cancer (NSCLC)

Summary: background: globally and nationally, malignant tumors persist as the leading cause of high incidence and mortality rates. in taiwan, cancer tops the list of causes of death, with the elderly being predominantly affected, especially by lung cancer, which is the most prevalent type with the highest mortality and incidence rates in the nation. the patient autonomy rights act, implemented by the government in 2019, is designed to promote advance medical care consultation in medical institutions, respecting patient's autonomous decisions. in chinese culture, medical decisions are typically family-oriented rather than individualistic, leading the elderly to frequently rely on their relatives'choices. this cultural practice may prevent meaningful conversations between potential agents and the elderly, causing misunderstandings of the elderly's preferences and affecting the consistency of medical decisions. presently, interventions like board games for advance care planning (acp) are not well received, highlighting the need for more captivating content in intervention strategies.


Eligibility criteria:
inclusion criteria: 1. lung cancer age ≧ 60 2. the elderly with lung cancer are conscious and have no severe visual or hearing impairment. 3.3. the potential agent is designated by the elderly person with lung cancer who may be a family member who may make medical decisions in the future. the potential agent must be at least 18 years old. exclusion criteria: 1. people with severe hearing loss and visual impairment who are unable to communicate in mandarin and taiwanese. 2. the potential agent is under 18 years old
treatment persistence of biologics in patients with psa in japan; retrospective cohort study using a claims database

Conditions: Psoriatic Arthritis

Summary: this study was a retrospective non-interventional cohort study with secondary use of data from the medical data vision (mdv) hospital-based database. the study setting was defined as follows: * the inclusion period covered 01 february 2015 to 30 september 2020. * the study period covered 01 august 2014 to 30 september 2021 inclusive. * the index date was defined as the date of the first prescription of secukinumab or adalimumab within the inclusion period. * the pre-index period was defined as the 6-month period before the index date (exclusive). * patients were followed until death, discontinuation of treatments of interest or end of the study period, whichever occurred first.


Eligibility criteria:
inclusion criteria: * having at least one biologic agent prescription of interest (secukinumab or adalimumab - princeps or biosimilars) recorded, in accordance with package insert, during the inclusion period (first prescription: index date). * having a confirmed diagnosis of psa (the international classification of diseases, 10th revision \[icd-10\]: l405) (at least 1 inpatient or outpatient claim without any doubtful flag) recorded during the pre-index period or at the index date. * being age 18 years or older at the index date. * having at least a 6-month pre-index period. bio-naive subgroup: • patients were considered as bio-naive if no record of any biologic agent prescriptions indicated for psoriasis or psa (infliximab, adalimumab, certolizumab pegol, ustekinumab, risankizumab, guselkumab, secukinumab, ixekizumab, brodalumab - princeps or biosimilars) were retrieved during the pre-index period. exclusion criteria: * having a biologic agent overdose (over 300 mg for secukinumab and over 80 mg for adalimumab) observed during the study period (off-label), * having at least one record of secukinumab (for secukinumab patients) or adalimumab (for adalimumab patients) retrieved during the pre-index period.

Keywords: psa
short term surgical outcomes of anatomical versus non anatomical laparoscopic liver resection for liver tumors

Conditions: Liver Neoplasms

Summary: aimed to discuss the short term surgical outcomes of anatomical versus non anatomical laparoscopic liver resection for liver tumors.

this study aimed to be both prospective and retrospective study including the cases of laparoscopic liver resection that was done and will be done during the period from december 2021 to june 2025. this study will include cohort of patients who met the eligible criteria. complete history taking with special concern to the following: * age, sex and life style. * present medical history: hepatic condition and other debilitating diseases. * past medical history: blood transfusion, hepatitis, liver cirrhosis and history of hospital admission. complete local examination of the abdomen including: * local examination of the skin overlying for any signs of infection, radiation fibrosis and or presence of sinuses * percussion for presence of ascites * palpation for cirrhosis or any palpable masses investigations will be carried 1. ultrasonography: routine abdominal us for every case. 2. triphasic ct scan 3. ct volumetric study to evaluate remaining liver volume when needed. 4. dynamic or triphasic mri if needed 5. metastatic work up (ct chest, bone scan and pet scan in selected patients). 6. preoperative histopathological examination when needed. 7. routine laboratory investigations

Eligibility criteria:
inclusion criteria: * all patients diagnosed with liver tumors (benign and malignant) lesions suitable for laparoscopic liver resection (anatomical and non anatomical) * patients with child pugh a and early b * patients fit for surgery as regard anesthesia * patients who accept to participate in the study and sign an informed consent exclusion criteria: * patients with child pugh late b\&c liver disease. * for patients with hepatocellular carcinoma bclc stage c\&d (extra hepatic spread and macro vascular invasion) * patients with contraindications to laparoscopic surgery and (or) unfit for surgery.
study of eyp-1901 in patients with nonproliferative diabetic retinopathy (npdr)

Conditions: Nonproliferative Diabetic Retinopathy

Summary: a prospective, randomized, double-masked study evaluating the ocular efficacy and safety of two doses of the eyp-1901 intravitreal insert compared to sham

this study will evaluate the the ocular efficacy and safety of two doses of the eyp-1901 intravitreal insert compared to sham using a randomized double masked trial design.

Eligibility criteria:
inclusion criteria: * participants must have a hemoglobin a1c ≤12% * study eye with moderately severe to severe npdr (based on the drss levels 47 or 53) * best corrected visual acuity (bcva) using early treatment diabetic retinopathy study (etdrs) letter score in the study eye of ≥69 letters (approximate snellen equivalent of 20/40 or better). exclusion criteria: * presence of any active center involved-diabetic macular edema in the study eye as determined by the investigator on clinical examination, or within the central subfield thickness (cst) of the study eye, with a cst threshold greater than 320 microns. * any evidence or documented history of prior focal or grid laser photocoagulation or any pan-retinal photocoagulation in the study eye in the last 12 months.

Keywords: npdr eyp-1901 eyepoint
safety, efficacy evaluation of recombinant coagulation factor viii injection in subjects with hemophilia a.

Conditions: Hemophilia A

Summary: this is a multi-center, open-label, single-arm trial to evaluate the efficacy and safety of recombinant coagulation factor viii in patients with hemophilia a . recombinant coagulation factor viii is prophylactic administrated 25 - 35 iu/kg once every other day or three times per week which should be continuous for 24 weeks.


Eligibility criteria:
inclusion criteria: 1. hemophilia a. 2. fviii:c \<1%. 3）12 and 65 years old. 4）has received fviii treatment and the treatment exposure days ≥100. 5）has bleeding treatment records of at least 3 months before randomization. 6）fviii inhibitor assay results is negative. 7） subjects should agree to use an adequate method of contraception during the study. 8）understood and signed an informed consent form. exclusion criteria: 1. has a history or family history of blood coagulation factor viii inhibitor. 2. has other coagulation dysfunction diseases in addition to hemophilia a. 3. hiv positive. 4. plan to receive surgery during the trial. 5. has used immunomodulator within one weeks before the first dose，and less than 7 half-life periods. 6. known to be allergic to experimental drugs or any excipients. 7. severe anemia and need blood transfusion. 8. serious liver or kidney damage. 9. serious heart disease. 10. uncontrollable hypertension. 11. has participated in other clinical studies within one month before the first dose. 12. the researchers believe that it is not suitable for participants.
patient registry of the european friedreich's ataxia consortium for translational studies (efacts)

Conditions: Friedreich's Ataxia

Summary: this is a multi-centre, multi-national, prospective, observational study of friedreich's ataxia (frda) with a control group to: * obtain natural history data on individuals affected by frda * relate clinical assessments and results from proteomic analyses * expedite identification and recruitment of participants for clinical trials * develop and validate sensitive and reliable outcome measures for detecting onset and change over the natural course of frda which may also be potential outcome measures for use in future clinical trials and clinical care * plan for future research studies

the efacts patient registry integrates prospectively and systematically collected clinical research data (e.g. clinical tests, demographical characteristics) with access to biological specimens (e.g. blood, urine) obtained from individuals with genetically confirmed frda and unrelated control research participants. the efacts patient registry started out as a 4-year study and is currently running without a set end date. eligible subjects are assessed at annual study visits on the clinical symptoms and signs of the disease. at each study visit, general clinical, motor function, cognitive, and quality of life assessments are administered. in addition, participants are providing bio samples for the purposes of genetic testing and for research to identify valuable biomarkers of frda. biological specimens and clinical data are made available to qualified scientists within the efacts network whose projects are reviewed and approved by the efacts steering committee. research projects should aim to advance scientific knowledge towards establishing clinically effective treatments that delay onset and/or slow the progression of the disease.

Eligibility criteria:
inclusion criteria: * genetic diagnosis of frda * for control research participants: genetically confirmed absence of frda

Keywords: friedreich's ataxia efacts frda
a study to assess the effectiveness and safety of mayzent in chinese patients with relapsing forms of multiple sclerosis

Conditions: Relapsing Multiple Sclerosis; Clinically Isolated Syndrome; Relapsing Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis

Summary: this was a multicenter, non-interventional, retrospective study aiming to evaluate the real-world effectiveness and safety of siponimod treatment in chinese patients with relapsing forms of multiple sclerosis (rms). the data were collected retrospectively through medical records review and abstraction conducted at a single time point per patient by the investigator's site staff or a designate (at the discretion of the site, if allowed by local regulations). there was no prospective patient follow-up for this study. obtaining informed consent was based on local regulations. where permissible, waivers could be applied to the institutional review board (irb) or independent ethics committee (iec) as appropriate, based on the retrospective collection of non-personally identifiable data, if acceptable per local regulations. the target patient population included adult patients diagnosed with rms (including clinically isolated syndrome (cis), relapsing-remitting multiple sclerosis (rrms), or active secondary progressive multiple sclerosis (spms)), and who received at least 3-months of treatment with siponimod after the index date. the index date is the date of siponimod initiation, defined as the date of first prescription record of siponimod in the patient's medical records with rms diagnosis. effectiveness data (i.e., clinical relapses, magnetic resonance imaging (mri) activity) were collected from the index date, through the end of the observation period. the observation period was from the index date to the date of initiation of medical records abstraction at site, or patient withdrawal of consent, loss of follow-up, or death, whichever occurred first. among patients who permanently discontinued siponimod during the observation period, safety data were collected up to 30 days after the last dose of siponimod.


Eligibility criteria:
inclusion criteria: * written informed consent if requested by local regulation. * patients had a diagnosis of rms (including cis, rrms, or active spms). * chinese patients were 18 years or older at the index date. * patients had a minimum 3-month persistence on siponimod after the index date. * patients had at least one documented clinical visit in the observation period after the initiation of siponimod treatment. exclusion criteria: • patients previously treated with siponimod (including participation in clinical trials) before the index date.
bone graft particle size on bone vitality and volume

Conditions: Bilateral Sinus Pneumatization; Posterior Maxillary Ridge Atrophy Due to Extraction

Summary: to determine the effects of small and large bone graft particles vs large particles alone on percent vital bone, percent residual graft material, measured histologically from bone biopsies of the grafted site taken at the time of dental implant placement from subjects undergoing sinus augmentation for the placement of dental implants. dental radiographs taken post operatively will be used to estimate bone graft volume differences between conditions.

the proposed study is a randomized, single-masked, split-mouth, single center study. about 20 subjects will be screened in order to randomize 10 study subjects. 10 patients who needing bilateral sinus augmentation procedure using the lateral window technique will be randomized using computer generated randomized technique. at the day of the surgical procedure each tooth sites will be randomized 1:1 into one of the following bone grafts to either the right or left side of the mouth.: * bone graft a: a mixture of 25% small-particle cortical allograft, 25% large-particle cortical allograft, 25% small-particle cancellous allograft, and 25% large-particle cancellous allograft is used for one sinus (n=10) * bone graft b: 100% large particle cancellous allograft for the contralateral sinus (n=10) immediately after the sinus augmentation surgery a cbct will be acquired and will be compared to a second cbct prior to implant placement in order to compare the volumetric changes in the sinus. at the visit of implant placement, a bone core will be collected from both sinuses for histomorphometric evaluation to evaluate the residual graft particles, the new vital bone formation and the amount of soft tissue components.

Eligibility criteria:
inclusion criteria: * good physical health * capable of maintaining good oral hygiene * missing posterior maxillary teeth on both sides and less than 5 mm of residual jaw bone requiring maxillary sinus augmentation prior to dental implant placement * capable and willing to give informed consent exclusion criteria: * the presence of underlying medical conditions that may pose an undue risk for sinus surgery * patients with untreated oral infections * pregnant and lactating females * individuals who have the habit of smoking and/or tobacco chewing * patients not willing to participate in the study

Keywords: sinus floor augmentation bone graft allograft dental implants maxillary sinus
cardiovascular injury and cardiac fitness in locally advanced non-small cell lung cancer patients receiving model based personalized chemoradiation

Conditions: Locally Advanced Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8

Summary: this study assesses cardiovascular injury and cardiac fitness in patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (locally advanced) receiving model based personalized chemoradiation. the goal of this study is to learn more about the risk of developing heart disease as a result of chemoradiation treatment for lung cancer. researchers also want to learn if the risk can be reduced by using a patient's individual risk profile to guide cancer treatment and help protect the heart.

primary objective: i.to longitudinally assess cardiac injury (serum biomarkers, and grade \>=2 cardiac events), and overall cardiac fitness (6-minute-walk test) in la-nsclc patients receiving chemoradiation. outline: patients undergo single photon emission computed tomography (spect)/computed tomography (ct) with stress test and echocardiogram with strain before radiation therapy (rt), 6-8 weeks and 12 months after completion of rt. patients also participate in 6 minute walk test (mwt) before rt, 2-3 and 6-7 weeks during rt, then 6-8 weeks, 4-6 months and 12 months after completion of rt. patients undergo blood sample collection and complete questionnaires over 3-5 minutes before rt, 2-3, 4-5, 6-7 weeks after the initiation of rt, then at 3, 6, 12, and 24 months after completion of rt. after completion of study treatment, patients are followed up annually for up to 10 years.

Eligibility criteria:
inclusion criteria: 1. patient with histologic diagnosis of non-small cell lung cancer, small cell lung cancer, or limited stage - small cell lung cancer (l-sclc) 2. the recommended treatment is thoracic radiation therapy combined with concurrent systemic therapy (chemotherapy and/or immunotherapy) with or without neoadjuvant and/or adjuvant systemic therapy (chemotherapy, immunotherapy, targeted therapy) 3. \>/= 18 years of age 4. kps \>/= 70 5. willing and able to sign informed consents 6. willing to perform 6minute walking test 7. willing to preform required cardiac biomarker test for primary end point assessment. exclusion criteria: 1. unable or unwilling to give written informed consent 2. previous history of rt to the thorax overlapping with the current treatment field. 3. pregnant or breast-feeding 4. renal failure necessitating dialysis 5. unwilling to perform protocol tests 6. contraindication for any protocol tests
local infiltration analgesia with ropivacaine versus placebo in bilateral hip arthroplasty

Conditions: Postoperative Pain; Hip Arthroplasty

Summary: high-volume infiltration analgesia may be effective in postoperative pain management following total hip arthroplasty. in this randomized, double-blind trial patients undergoing bilateral hip arthoplasty are randomized to receive high-volume local anesthetic infiltration in one hip and similar infiltration with saline (placebo) in the other hip.


Eligibility criteria:
inclusion criteria: * scheduled for bilateral total hip arthroplasty * able to speak and understand danish exclusion criteria: * treatment with opioids or steroids

Keywords: postoperative pain total hip arthroplasty
phase 2 clinical trial of gh001 in bipolar ii disorder

Conditions: Bipolar II Disorder

Summary: this study is a multicenter, open-label, single-arm phase 2 clinical trial. approximately 15 participants with clinically diagnosed bipolar disorder (bd) type ii and experiencing a current episode of depression will be included in this study. the participants will receive an individualized dosing regimen (idr) with at least one and up to three doses of gh001 administered within a single day.


Eligibility criteria:
inclusion criteria: * is male or female and in the age range between 18 and 64 years (inclusive) at screening * has a body mass index (bmi) in the range of 18.5 and 35 kg/m2 (inclusive) at screening * meets the trial criteria for bipolar ii disorder and is experiencing a major depressive episode, as assessed by a trial psychiatrist or registered clinical psychologist exclusion criteria: * has bipolar ii disorder with rapid cycling (four or more episodes of hypomania or depressive episodes in previous 12-month period) * has, based on history, psychiatric assessment, and evaluation of the mini, a current or prior diagnosis of bipolar i disorder, a manic episode, a psychotic disorder, mdd or other mood disorder with psychotic features, obsessive compulsive disorder, ptsd, autism spectrum disorder, borderline personality disorder, schizophrenia, delusional disorder, paranoid personality disorder, schizoaffective disorder, clinically significant intellectual disability, or any other psychiatric comorbidity that renders the patient unsuitable for the trial according to the investigator's judgment * has one or more first degree relatives with a current or previously diagnosed psychotic disorder, bipolar i disorder or mdd with psychotic features * has taken prohibited medication or prohibited dietary supplements within the specified timeframe prior to dosing * has previously experienced a significant adverse reaction to a hallucinogenic or psychedelic drug according to the investigator's judgment * has a clinically significant abnormality in physical examination, vital signs, ecg, or clinical laboratory parameters which renders the patient unsuitable for the trial according to the investigator's judgment

Keywords: depression bipolar disorder 5-methoxy-n,n-dimethyltryptamine 5-meo-dmt mebufotenin
study of premedication before laryngoscopy in neonates in france

Conditions: Neonatal Respiratory Distress

Summary: this study is a national prospective survey on practices of premedication before laryngoscopy in neonates. the survey will evaluate adequation to the french best practice guidelines to improve their dissemination and to identify current practices of premedication before laryngoscopy in neonates in french units (agents, dosing, efficacy, safety)

laryngoscopy for intubation or less invasive surfactant administration (lisa) in neonates is a stressful and painful procedure that necessitates a sedo-analgesia except in the case of an immediate life-threatening emergency. nevertheless, there are discrepancies in premedication practices amongst neonatal units. in order to optimize analgesia before laryngoscopy in neonates, the french neonatal society issued best practice guidelines in january 2023 for premedication before laryngoscopy in neonates. these guidelines were published in an english peer-reviewed journal and presented in national conferences. however, the implementation of new premedication protocols in neonatal units can be made difficult due to local habits, poor dissemination of the guidelines and a limited level of evidence on some premedication agents. thus, conducting a survey one year after issuing the best practice guidelines on premedication seems important to evaluate french premedication practices and to evaluate the impact and dissemination of the guidelines

Eligibility criteria:
inclusion criteria: * every neonate (corrected gestational age \< 45 weeks of gestation) that undergoes a laryngoscopy (for intubation or lisa) or a laryngeal mask insertion, that received a premedication or not during the 28 days of the survey. exclusion criteria: * laryngoscopy or laryngeal mask insertion in the operating room * opposition to data collection of a parent or holder of parental rights

Keywords: sedo-analgesia laryngoscopy neonatal icu intubation