Kornimate/medical-research-clean huggingface dataset:
closed vs. open face masks for cranial radiotherapy

Conditions: Brain Tumor; Brain Metastases; Small Cell Lung Cancer; Meningioma

Summary: the aim of the study is to evaluate whether open-face masks improve patient comfort/preference whilst maintaining immobilization performance as known for closed masks in patients undergoing whole or partial cranial radiotherapy.

upon randomization, patients will be begin treatment either with an open-face mask (a) or closed mask (b). two individual immobilization masks - the open-face and closed masks - will be fabricated for every single patient. during the 1st half of treatment the randomly assigned mask will be used followed by using another mask for the 2nd half of treatment. discomfort/pain/anxiety and mask preference will be scored during treatment with a questionnaire.

Eligibility criteria:
inclusion criteria: * written informed consent according to swiss law and international council for harmonization (ich)/good clinical practice (gcp) regulations before any trial specific procedures; * indication for cranial radiotherapy irrespective of tumor type; * age: ≥ 18 years old; * karnofsky performance status ≥70; * patients who are willing and able to comply with scheduled visits, treatment, and other trial procedures. exclusion criteria: * cranial radiotherapy in less than 10 fractions; * prior brain irradiation; * inability to complete magnetic resonance imaging (mri) procedure due to claustrophobic anxiety; * women who are pregnant or breast feeding; * intention to become pregnant during the course of the trial; * lack of safe contraception; * known or suspected non-compliance, drug or alcohol abuse
effectiveness of celecoxib after surgical sperm retrieval

Conditions: Pain

Summary: while narcotic medication are commonly used for pain control near the time of surgery, there are significant side effects including constipation, nausea, risk of overdose leading to decreased breathing, and risk of addiction to narcotics. our goal is to explore alternatives to narcotics for perioperative pain for patients undergoing sperm retrieval surgery. we have designed a prospective randomized clinical trial to evaluate how effective the anti-inflammatory medicine celecoxib(celebrex©) is for pain control near the time of surgery. celecoxib is known as a cox-2 inhibitor, a drug that belongs to the non-steroidal anti-inflammatory drug (nsaid) class. it is used to reduce swelling and to treat pain. patients will be divided into two groups: the first group receives a celecoxib pill and the second group receives a sugar pill(placebo). patients and doctors will be unaware of exactly which pills are given. the patient will complete questionnaires for pain level. by comparing the pain levels we can better understand whether celecoxib (celebrex©) significantly decreases perioperative pain.

all consecutive patients scheduled to undergo elective, outpatient microsurgical testicular sperm extraction (tese) beginning in 9/2011 will be invited for participation. microdissection tese will be performed unilaterally or bilaterally, through a midline scrotal incision, under general anesthesia. participants will be prospectively randomized in a 1:1 ratio to receive 200 mg of celecoxib or placebo b.i.d. in a double-blind fashion, initiated the night prior to surgery, and continued for six days thereafter. the randomization sequence will be generated and implemented by the institutional investigational pharmacy. placebo medication, identical to the study medication, will also be provided by the institutional pharmacy. following surgery, all participants will be asked to complete a take-home post-operative questionnaire recording their maximum pain level on an 11-point visual analog scale (0-10), at specific time intervals over the course of the day, ranging from every six hours on post-operative day (pod) #1 to every 8 hours on pod #2, every 12 hours on pod #3, and every 24 hours on pod #4 to pod #7. patients will also record the number of 5/500 mg tablets of acetaminophen/hydrocodone used for supplemental pain control from pod #1 to pod #7. thirdly, patients will record whether or not their pain was adequately controlled at each of the above-mentioned time intervals.

Eligibility criteria:
inclusion criteria: 1. \>/= 18 years old 2. male 3. scheduled to undergo microdissection testicular sperm extraction exclusion criteria: 1. history of allergies to celecoxib (celecoxib) 2. renal failure 3. history of ulcer disease 4. any history of myocardial infarction 5. any history of stroke 6. history of bleeding diathesis 7. use of aspirin

Keywords: pain control testicular sperm extraction sperm
retrospective analysis of the clinical characteristics of retinal vein occlusion

Conditions: Retinal Vein Occlusion

Summary: to explore the clinical characteristics of patients with rvo, and to analyze the relationship between rvo and various underlying diseases, ocular conditions, lifestyle, imaging findings and treatment response. to systematically analyze the clinical data of patients with different types of rvo, further reveal the potential mechanism of its occurrence and development, and evaluate the efficacy and safety of different treatment methods, in order to provide more scientific basis for clinical treatment.

to explore the clinical characteristics of patients with rvo, and to analyze the relationship between rvo and various underlying diseases, ocular conditions, lifestyle, imaging findings and treatment response. to systematically analyze the clinical data of patients with different types of rvo, further reveal the potential mechanism of its occurrence and development, and evaluate the efficacy and safety of different treatment methods, in order to provide more scientific basis for clinical treatment. patients discharged from our hospital from january 2018 to december 2024 with the diagnosis of retinal vein occlusion were retrospectively investigated. the medical history of each patient was reviewed, and the basic information, past medical history, eye examinations and their results, treatment plans, and prognosis information of the patients were recorded in detail.

Eligibility criteria:
inclusion criteria: * meeting the diagnostic criteria for rvo (including brvo and crvo) exclusion criteria: * patients with other ocular diseases other than rvo, such as iridocyclitis, age-related macular degeneration, central serous chorioretinopathy and optic neuropathy; * patients with systemic inflammatory diseases and other systemic diseases other than diabetes, hypertension, coronary heart disease and cerebral infarction that may affect blood indexes; * patients with incomplete clinical data and information.

Keywords: retinal vein occlusion clinical feature therapy
intraoperative mechanical ventilation and postoperative pulmonary complications after on-pump cardiac surgery in high-risk patients

Conditions: Postoperative Pulmonary Complications

Summary: controversies remain concerning the best intraoperative mechanical ventilation regimen for major cardiac surgery. while the use of intra operative low tidal volumes is now standard practice, the optimal level of positive end-expiratory pressure (peep) and the use of recruitment maneuvers (rm) remain controversial. the aim of this study is to compare two regimens of intraoperative mechanical ventilation on postoperative outcomes in cardiac surgery patients at risk of postoperative pulmonary complications

in this randomized controlled trial, cardiac surgery patients at risk of postoperative pulmonary complications will be assigned to intraoperative ventilation with high peep and rm or intraoperative mechanical ventilation with low peep and without rm. the primary endpoint will be a composite endpoint including major postoperative complications within the first postoperative week and death within the 28 days after surgery

Eligibility criteria:
inclusion criteria: * patients older than 18 years-old, * evaluated before cardiopulmonary bypass for any cardiac surgical procedure (e.g. coronary artery bypass grafting, valve, aorta, or combined procedures), * with a pulmonary risk score ≥ 2 * who gave written informed consent * affiliated to a social security system exclusion criteria: * bmi \> 40kg/m2 ; * left ventricular ejection fraction \< 35% ; * preoperative shock ; * aortic surgery with planned circulatory arrest ; * minimally invasive cardiac surgery ; * emergency surgery with patient unable to give written informed consent * heart transplantation * mechanical circulatory support surgery * pregnant or lactating women * adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty

Keywords: recruitment maneuvers postoperative pulmonary complications peep cardiac surgery mortality
the effect of vitamin d supplements on vitamin d status, cardiometabolic health and immune defense in danish children

Conditions: Vitamin D Deficiency

Summary: the main purpose of this study is to investigate whether and in which doses vitamin d intake is needed in order to maintain an adequate vitamin d status in 4-8 year-old danish children during wintertime.

the main objective of odin junior is to investigate whether and in which doses vitamin d intake is needed in order to maintain serum 25(oh)d concentrations above deficiency and insufficiency cut-offs (30 nmol/l and 50 nmol/l, respectively) in 4-8 year-old danish children during the winter time. the children will be randomized to receive tablets with either 10 micrograms/day or 20 microgram/day of vitamin d3 (cholecalciferol), corresponding to one and two times the recommended daily intake in children, or placebo for 20 weeks. measurements and blood sampling will be performed before the beginning and by the end of the intervention.

Eligibility criteria:
inclusion criteria: * 4-8 years at the start of the intervention * healthy * of white, danish/european origin * children must be danish-speaking * parents must read and speak danish * not planning a winter vacation south of a latitude of 51°north (corresponding to surrey, england) exclusion criteria: * diseases that may interfere with vitamin d or calcium metabolism * intake of medication known to affect vitamin d or calcium metabolism * use of vitamin d containing supplements ≥ 4 days/week the last 8 weeks before intervention start and use of any vitamin d containing supplements the last 4 weeks before intervention start * concomitant participation in other studies involving dietary supplements or blood sampling * serum calcium \> 2.7 mmol/l at baseline

Keywords: vitamin d children supplements cardiometabolic markers immune defense bone turnover muscle strength
nutrition practice in critically ill adults

Conditions: Critical Illness

Summary: to determine the role of nutrition in recovery from critical illness, current practice must first be understood. however, no benchmarking process currently exists for nutrition practice during critical illness, from icu admission to hospital discharge. this vital gap requires addressing. the aim of this study is to inform and re-design models of nutrition care and generate research priorities for the future by obtaining data on nutrition provision and practice and that of consumer preference for nutrition care.

this study is a multi-centre observational study of nutrition practices in critically ill adults across anz. two study periods are proposed, the first confirmed period in q3-2024 and the second in 2026. this study is part of a larger study which consists of three interconnected streams. this study forms part of stream 2 which is about understanding nutrition practice and provision in adults with critical illness. the findings from this study will be used to inform the development and implementation of new models of nutrition care for adults with critical illness. on the day of study commencement (day 1), all patients treated in the icu and admitted to the icu after 00:00 will be screened for eligibility. observational data will be collected days 1 and 3 of their icu stay (whilst present in icu) and then days 7, 14, 21 and 28 (whether they are in icu or the ward) as well as the first full day on the ward (day after icu discharge). at the completion of the project, the investigators will hold the largest sample of nutrition care in critical illness in australia (approximately 1200 adult patients including the pilot data period) and the only international database to include the period after icu discharge. this proposal directly links with the national safety and quality health service (nsqhs) standard 5 (comprehensive care) and standard 2 (partnering with consumers) and will rapidly provide data about nutrition care and hospital acquired malnutrition (a serious reportable consequence under standard 5) to inform the accreditation process and provide a risk mitigation strategy to prevent malnutrition before it occurs. this data will be used to improve and re-design nutrition care, as well as generate new research priorities that are highly relevant to issues within clinical care, with the potential to save millions of dollars in healthcare expenditure nationally.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. admitted to icu after 00:00 on the date of study commencement 3. remain in icu for ≥ 48 hours exclusion criteria: 1. patients who have been deemed ready to be discharged by the treating team within 48 hours of icu admission but have not been able to be discharged within 48 hours of icu admission for logistical reasons (e.g., due to bed unavailability, inability to return home) 2. patients who have been admitted for palliative care or organ donation or made palliative within 48 hours of icu admission

Keywords: intensive care nutrition
prediction of systemic thromboembolism and bleeding in atrial fibrillation patients with factor xa inhibitor (apixaban, rivaroxaban) by echocardiographic parameters: prospective observational study (af-echo study)

Conditions: Atrial Fibrillation (AF)

Summary: patients taking factor xa inhibitors (apixaban, rivaroxaban) in atrial fibrillation will be conducted a follow-up investigation on systemic embolism and bleeding events.

this study aims to evaluate 1) the efficacy and safety of factor xa inhibitors (apixaban, rivaroxaban) in atrial fibrillation patients who meet the inclusion criteria, and 2) the relationship between systemic embolism and bleeding by tracking and analyzing echocardiographic data, with the goal of developing an af-echo noac score to predict these events. additionally, we aim to create a predictive model for thromboembolic and bleeding events by observing the occurrence and progression of mitral and tricuspid regurgitation due to atrial remodeling and annular dilation in atrial fibrillation.

Eligibility criteria:
inclusion criteria 1. male and female patients aged 19 years or older with chronic atrial fibrillation, accompanied by at least one of the following conditions: ① heart failure ② 2. myocardial infarction (more than 3 months post-event) ③ 3. angina (if pci was performed, more than 3 months post-procedure) ④ 4. hypertension ⑤ 5. diabetes mellitus 2. patients who started taking factor xa inhibitors (apixaban, rivaroxaban) within the last 12 months and have echocardiographic images taken within 3 months of that time, which are available for analysis. 3. patients who are starting treatment with factor xa inhibitors. (apixaban, rivaroxaban) 4. individuals who have voluntarily provided written consent to participate in this clinical trial. exclusion criteria 1. patients with creatinine clearance (ccr) less than 15 ml/min. 2. patients with moderate to severe mitral stenosis. 3. patients who have undergone mechanical valve replacement 4. patients with a history of clinically significant alcohol or drug abuse. 5. patients whom the investigator deems legally or mentally unsuitable for participation in the clinical trial, or those who do not consent to participate in the study.

Keywords: apixaban, rivaroxaban
treatment of elderly patients (>65 years) with acute lymphoblastic leukemia

Conditions: Adult Acute Lymphocytic Leukemia

Summary: the aim of this study is to test feasibility and efficacy of a dose reduced chemotherapy in elderly patients with newly diagnosed acute lymphoblastic leukemia. the regimen consists of induction phase i and ii followed by cyclic consolidation cycles, reinduction and maintenance therapy


Eligibility criteria:
inclusion criteria: * diagnosis of acute lymphoblastic leukemia (pro-b,common,pre-b,pre-t,thy-,mature t, b-all) * age \> 65 years * written informed consent * karnofsky \> 50% (if not mainly caused by leukemia) * laboratory at diagnosis or after supportive pre-treatment creatinine \< 2 mg/dl uric acid \< 8 mg/dl bilirubin \< 1.5 mg/dl ala, asa,ap \< 2.5 x uln exclusion criteria: * severe second diseases (e.g. renal failure, cardiomyopathy etc., not caused by leukemia) that exclude treatment according to the protocol * severe psychiatric illness or other circumstances which may compromise cooperation * active second neoplasia * clinical signs of life threatening infections or bleeding, uncontrollable prior to chemotherapy

Keywords: all elderly chemotherapy
lacosamide versus propranolol in migraine

Conditions: Migraine Disorders

Summary: investigators aim to compare the effect of lacosamide versus propranolol in migraine by assessing the absolute reduction in mmd in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency.

investigators will enroll 600 migraine patients who are diagnosed according to ichd3-beta criteria in our study and will use a questionnaire to detect their demographic and clinical features (disease duration, attack frequency, and duration, pain intensity assessed by the visual analogic scale and we have two groups the first group will include 300 patients and will receive 50 mg lacosamide twice daily, and the second group will receive propranolol 160 mg per day. investigators will assess the number of migraine days after three months of treatment and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency (14). hit-6 score reduction in each group after three months of treatment. the safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (teae) in patients through regular follow-up procedures for three months.

Eligibility criteria:
inclusion criteria: * naive migraine patients, according to the international classification of headache disorders 3rd edition, aged 18-75 years, exclusion criteria: * patients with major neurological disorders such as ( epilepsy, ischemic or hemorrhagic stroke, multiple sclerosis, mitochondrial diseases, brain tumors, and patients with essential tremors. * patients with major systemic diseases such as malignancy, collagen, liver, and renal diseases. * patients with cardiovascular diseases like hypertension (systolic blood pressure of more than 130 and/or diastolic blood pressure of more than 85 mm/hg on at least three different occasions, diabetes (fasting plasma glucose level \>126 mg/dl and/or a casual plasma glucose \>200 mg/dl and/or hba1c more than 6.5. * patients with valvular and ischemic heart diseases, bradycardia or heart blocks, congestive heart failure * patients who received prophylactic treatment for migraine, * patients with any contraindications to drugs used in the study * patients with bronchial asthma, chronic obstructive pulmonary disease

Keywords: lacosamide migraine propranolol
maintenance plasma exchange for neuromyelitis optica

Conditions: Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorder; Recurrent Idiopathic Longitudinally Extensive Transverse Myelitis

Summary: neuromyelitis optica (nmo) is an inflammatory disease of the central nervous system that is associated with autoantibodies to aquaporin-4. treatment options for prevention of clinical relapses of nmo include immunosuppressive medications. plasma exchange (plex) is commonly used as a rescue therapy for nmo relapses but ongoing, regular plex procedures (maintenance plex) is sometimes used to prevent relapses. this observational registry will record feasibility, tolerability, safety, and preliminary efficacy data regarding maintenance plex for nmo.

neuromyelitis optica (nmo) is an inflammatory disease of the central nervous system that is associated with autoantibodies to aquaporin-4. treatment options for prevention of clinical relapses of nmo include immunosuppressive medications. plasma exchange (plex) is commonly used as a rescue therapy for nmo relapses but ongoing, regular plex procedures (maintenance plex) is sometimes used to prevent relapses. this observational registry will record feasibility, tolerability, safety, and preliminary efficacy data regarding maintenance plex for participants with nmo, nmo spectrum disorders, and recurrent idiopathic longitudinally extensive transverse myelitis.

Eligibility criteria:
inclusion criteria: * neuromyelitis optica * neuromyelitis optica spectrum disorder * recurrent idiopathic longitudinally extensive myelitis * age 18 years or greater exclusion criteria: * any condition that in the opinion of the investigator could increase a participant's risk by participating in the observational study or confound the outcome of the study
is long-term use of amantadine effective in pd?

Conditions: Parkinson Disease

Summary: the investigator aims to assess whether long-term use of amantadine is effective in patients with parkinson's disease.

amantadine is used in the early stages of parkinson's disease (pd). however, amantadine is known to be relatively weak compared to other antiparkinsonian drugs such as levodopa, dopamine agonist or mao-b inhibitor and its effects are limited in early months, so it is rarely used than other drugs. recently, several studies have identified the long-term effects of amantadine on dyskinesia, but the basis is still insufficient. therefore, this study aims to investigate the long-term effectiveness of amantadine in patients with pd. participants who have used amantadine since the early stages of diagnosis undergo clinical evaluations including the montreal cognitive assessment (moca), movement disorder society-unified parkinson's disease rating scale (mds-updrs), freezing of gait-questionnaire (fog-q), non-motor symptom scale (nmss) and parkinson's disease questionnaire-39 (pdq-39). then, participants stop taking amantadine. to investigate the long-term effect, clinical evaluations except moca are repetitively assessed at 4- and 8-week follow-ups.

Eligibility criteria:
inclusion criteria: 1. patients who have been taking amantadine since the beginning of diagnosis 2. patients who have taken amantadine for more than five years 3. patients with parkinson's disease who are aged 40 years or older exclusion criteria: 1. patient who stops amantadine or is hypersensitive to amantadine 2. patients who have undergone brain surgery, including deep brain stimulation 3. patient identified as atypical parkinsonism 4. patients with psychiatric conditions such as dementia, major depression or bipolar disorder who are difficult to assess 5. patients who are currently unable to follow up at our hospital

Keywords: parkinson's disease amantadine long-term effect