Kornimate/medical-research-clean huggingface dataset:
new-onset severe headache after covid-19 vaccine

Conditions: Headache; Migraine; COVID-19

Summary: hypotheses: 1. severe new-onset headache after covid-19 vaccine occur in a minor subset of vaccinated individuals. 2. immunological reactivity with activation of trigeminal nociceptors can be among the mechanisms in severe headaches after covid-19 vaccines. 3. biomarkers in blood and csf and imaging findings can be used to assess severe new-onset headache after covid-19 vaccines. the main aim of the project is to describe the characteristics of severe new-onset headache after covid vaccine and the treatment effects. secondary aim: 1. investigate potential mechanisms and analyse biomarkers to predict treatment effects. 2. to assess at baseline and 6-month follow-up the rate of brain mri pathology. 3. to assess the change xof brain 18f-fdg pet metabolism from baseline and 6-month follow-up 4. to assess the levels of brain specific biomarkers 5. to assess the level of blood specific biomarkers duration of study participation: * enrollment: 24 months * follow-up: at 3 and 6 months after inclusion. for those with continued severe headache regular 3-month controls are planned during the study. total study duration 24 months

study design: prospective observational multi-center study cohort study of patients with new-onset severe headache after covid-19 vaccine. patients referred to the participating headache clinics for severe headache after covid vaccine will be invited to participate in the study. the invitation will be given in conjunction with their visit to the headache specialist. patients already diagnosed and treated for severe headache after covid vaccine will be invited to participate during control visits at the participating centres. after written informed consent information information from the initial phases will be collected retrospectively from the medical records of the patients that have already been diagnosed and started with treatment. further information will be collected prospectively. for newly diagnosed patients all information will be collected prospectively. blood samples will be drawn to assess immunological mechanisms. inclusion criteria: * patients aged ≥ 18 years with new onset severe headache or severe worsening of pre-existing headache within one week after covid vaccination and has not resolved within 3 weeks. * inclusion within 12 months after symptom onset. * informed written consent signed by the patient. exclusion criteria: • patients not available for follow-up assessments (e.g. non-resident).

Eligibility criteria:
iinclusion criteria: * patients aged ≥ 18 years with new onset severe headache or severe worsening of pre-existing headache within one week after covid vaccination and has not resolved within 3 weeks. * inclusion within 12 months after symptom onset. * informed written consent signed by the patient. exclusion criteria: • patients not available for follow-up assessments (e.g. non-resident).
environmental risk factors of mesh infection after abdominal wall hernia repair

Conditions: Surgical Site Infection

Summary: mesh infection is the main complication in abdominal hernia repair. in case of infection, a conservative management of mesh is not always possible. the removal of the mesh (occurring in 5.1% to 8% of wall hernia repair) increases the risk of recurrence and surgical morbidity. within our digestive surgery department (chru de nancy), an infection rate of 10.7% (32 cases out of 298 patients with wall hernia repair) was observed between january 2016 and december 2018. this rate is higher than those usually described in the literature. several studies have identified predictors of mesh infection and explantation after abdominal wall hernia repair. the influence of the operating environment (temperature, hygrometry, pressure, number of people present, etc.) has, to our knowledge, never been studied. if the risk of prosthesis infection is influenced by one or more of these extrinsic characteristics, it is possible to act on these practices to reduce this risk. the main purpose of this study is to identify the characteristics specific to the intervention and the operating environment associated with mesh infection after abdominal wall hernia reconstruction

it's a prospective, mono-centric study carried out on a cohort of patients followed in the digestive surgery department of the chru of nancy all patients who underwent a wall hernia repair between 28/12/2017 and 28/12/2020 in the digestive and general surgery department of the chu of nancy were included. during the operative time, the nurses have to fill a survey with characteristics specific to the intervention and the operating environment. patients in this study have been followed for at least one year at the nancy chru in order to be aware of the occurence of mesh infection and surgery for mesh explantation.

Eligibility criteria:
inclusion criteria: * all patients admitted for wall hernia repair with mesh between 28/12/2017 and 28/12/2020 exclusion criteria: * emergency surgery * laparoscopic * pregnancy * adults under legal guardianship
assessment of end-tidal carbon dioxide levels in respiratory disease

Conditions: Respiratory Disease

Summary: the investigators aim to evaluate the correlation between petco2, paco2, and ptcco2 in patients with respiratory diseases. the investigators also evaluate the correlation between petco2, paco2, and ptcco2 changes over time.

partial pressure of carbon dioxide(pco2) is mainly evaluated by partial pressure of arterial carbon dioxide (paco2), and is used as an index for prognosis and nppv introduction in chronic respiratory failure. arterial blood gas analysis for paco2 measurement is the most accurate test value, but it is invasive and frequent tests are difficult and cannot be performed at home. the transcutaneous pco2 (ptcco2) is a non-invasive measurement and its measured value is close to paco2, and it can be measured continuously, which is useful for monitoring patients with chronic respiratory failure. however, ptcco2 has not been applied at home due to technical problems (necessity of calibration, periodic drift, etc.). the end-tidal pressure of expired co2 (petco2) can be measured non-invasively, easily and continuously. petco2 is mainly used for patients undergoing mechanical ventilation, and its accuracy and stability have been evaluated. the investigators decided to investigate whether petco2 is useful for monitoring respiratory status in patients with respiratory disorder.

Eligibility criteria:
inclusion criteria: * subjects with respiratory disorder. * subjects who are clinically stable for the last 2 weeks exclusion criteria: * subjects who required treatment with antibacterial agents or oral/intravenous steroids for pneumonia or exacerbation of respiratory disease in the last 2 weeks. * subjects with severe complications such as cardiovascular disease, liver disease, renal disease, and neurological disease.

Keywords: petco2
incidence of mesh infection after hernioplasty in obstructed and strangulated hernia using proline mesh and sutures

Conditions: Incidence of Mesh Infection In Hernioplasty

Summary: the primary aim of this study is to detect incidence of mesh infection in cases presented with obstructed or strandulated hernia.a prospective controlled study will be carried out after obtaining written informed consent from all patients and approval of the ethics committee of the faculty of medicine, assuit university.

there is controversy regarding the use of prolene mesh in cases of obstructed and strangulated hernia. the main aim and objective of this prospective study is to evaluate the outcomes and incidence of mesh infection in hernioplasty in emergency situations like obstructed and strangulated hernia .hernioplasty is the most common surgery for hernia repair with propylene mesh,but the use of synthetic prosthesis is associated with increase risk of developing a prosthetic infection that may manifest after time as subtle symptoms in the form of fever, myalgia, erythema of overlying skin and in some cases as chronic discharging sinus(1). clinicians have been challenged in the past few years by an increasing variety of novel non-infectious and infectious complications following the widespread use of meshes after open repair of hernias this incidence is influenced by underlying co-morbidities, the type of mesh, the surgical technique and the strategy used to prevent infections. an approach that combines medical and surgical management is necessary for cases of mesh infection.(2)

Eligibility criteria:
inclusion criteria: * all adult patients aging above 21 years old, who presented with obstructed or strangulated hernia with viable bowel loops by clinical examination or detected by preoperative ultrasound or computed tomography ct imaging. exclusion criteria: * uncomplicated hernia. * patients who will underwent rescection and anastmosis * patient cannot withstand anethesia. * decompensated liver patients. * pregnancy. * immunosuppressed patients e.g.: under chemotherapy or steroids.
optimize motor learning to improve neurorehabilitation

Conditions: Stroke; Neurologic Disorder

Summary: the objective of this study is to develop and evaluate novel robotic training strategies that modulate errors based on the subjects' individual motor and cognitive needs. for this purpose, healthy adults and neurologic patients will participate in robotic motor learning experiments. patients have a diagnosis of a neurological disease (i.e., stroke, spinal cord injury, multiple sclerosis, guillain-barré syndrome) limiting arm motor function.

neurological patients (e.g., after stroke) engage in intensive and expensive neurorehabilitation therapy to regain part of their former motor functional ability to perform everyday activities with often limited and unsatisfactory outcome. robots became a promising supplement or even alternative for neurorehabilitation therapy, providing cost-effective, high repetition and task-oriented training. however, results of an initial body of work comparing the effectiveness of robotic training strategies are highly inconclusive. a possible explanation is that most current robotic systems cover only one neurorehabilitation strategy (e.g. reducing or augmenting movement errors) and may thus insufficiently address the subjects' individual needs and the characteristics of the task to be learned. in this study, investigators will perform several motor learning experiments with healthy adult and neurological patients in order to evaluate the relative motor and cognitive benefits of newly developed robotic training strategies that modulate errors based on the subject's age, skill level and tasks characteristics. the effects of the new strategies will be compared to classical robotic assistance, and to non-robotic feedback approaches, such as visual feedback. the culmination of this work may help to optimize training benefits of already existing rehabilitation robots.

Eligibility criteria:
inclusion criteria: * aged ≥18 years * informed consent as documented by signature ("informed consent" form) * bodyweight \<120 kg * ability to communicate effectively with the examiner so that the validity of the patient's data could not be compromised exclusion criteria: * excessive spasticity of the affected arm (ashworth scale ≥3) * serious medical or psychiatric disorder * orthopaedic, rheumatological, or other disease restricting movements of the paretic arm * shoulder subluxation * skin ulcerations at the paretic arm * cyber-sickness (i.e., nausea when looking at a screen or playing computer games) * serious cognitive defects or aphasia preventing effective use of the robotic devices * severe visual and auditory impairments

Keywords: neurorehabilitation robotic rehabilitation motor learning
csp #2026 - beta blocker dialyzability on cardiovascular outcomes

Conditions: End-Stage Kidney Disease; End-Stage Renal Disease

Summary: the investigators aim to determine, using a point-of-care randomized controlled trial design, if hemodialysis patients, who are randomized to metoprolol succinate (a dialyzable, beta-1 selective beta blocker), have an improved cardiovascular outcome compared to those randomized to carvedilol (a non-dialyzable, non-selective beta blocker with alpha-1 antagonist properties). the investigators will also examine intervention practices to identify components that best support engagement and sustainability.

approximately 35,000 veterans have end stage kidney disease (eskd) with an incidence of 13,000 annually. these numbers are increasing because of the epidemic of diabetes, the most common cause of eskd, among the veteran population. patients with eskd on hemodialysis have substantial cardiovascular morbidity. veterans annual mortality is in excess of 15% and more than half the deaths are due to cardiovascular disease. beta blockers have been shown to prevent cardiovascular events in randomized clinical trials in patients without chronic kidney disease, particularly those with heart failure and after myocardial infarction. beta blockers are a mainstay of therapy in dialysis patients, with two-thirds of veterans on dialysis receiving a beta blocker. there are no head-to-head randomized studies comparing the two most commonly used beta blockers in eskd patients in the united states, metoprolol and carvedilol, but observational studies suggest superior outcomes for patients treated with metoprolol. the identification of the superior beta blocker may significantly improve the morbidity and mortality of the va dialysis population. the investigators aim to compare two beta blockers with similar indications, usage and availability within the va but with major differences in patients dialysis clearance and adrenergic effects. the investigators aim to determine if patients undergoing dialysis have improved survival when using metoprolol succinate, a beta blocker that is removed by dialysis and is beta-1 selective, compared to carvedilol, a beta blocker that is not removed by dialysis and is not beta-selective and is also an alpha-blocker.

Eligibility criteria:
inclusion criteria: * eligible patients are those (including men, women and minorities) * on hemodialysis * received one of the following beta blockers through the va pharmacy: metoprolol (succinate or tartrate), atenolol, labetalol, carvedilol, bisoprolol exclusion criteria: * impaired decision-making capacity * patients not receiving carvedilol who have a history of asthma * known hypersensitivity to any component of either drug * provider unwilling to sign a new medication order for a randomized patient * no surrogate consent will be allowed

Keywords: dialysis beta-blockers, adrenergic cardiovascular diseases point of care research comparative effectiveness research metoprolol succinate carvedilol hemodialysis
exploring the complex links between menstrual irregularity and cellular markers

Conditions: Menstrual Irregularity; Menstrual Cycle Abnormal

Summary: a cross-sectional study design was employed, involving 56 premenopausal participants with ages ranging from 20 to 49 years. serum samples were collected during the early follicular phase, and levels of some biochemicals parameters analyzed.

a cross-sectional study was conducted to investigate the potential relationship between menstrual regularity and the apoptosis marker caspase-cleaved cytokeratin 18 fragment (m30), asymmetric dimethylarginine (adma), and malondialdehyde (mda) levels. the investigators screened 80 participants who applied for menstrual irregularity between 2023 february and 2024 march and, in addition to menstrual irregularities, 24 individuals with additional gynecological conditions such as polycystic ovary syndrome (pcos) and endometriosis were excluded from the study. in the overall study population of 56 subjects aged 20-49 were recruited from, sivas cumhuriyet university faculty of medicine research and practice hospital, gynecology and obstetrics clinic. participants were divided into two groups: irregular menstrual cycle (28 participants) and regular menstrual cycle control group (28 participants). while those who met the criteria for menstrual irregularity were included, those with another gynecological disease (pcos, endometriosis, etc.) and additional diseases (diabetes, insulin resistance, cancer, heart disease, etc.) were excluded from the study. all participants provided written informed consent before participating in the study. the study protocol was approved by the sivas cumhuriyet university, clinical research ethics committee chairman, 2023-02/06. all procedures were performed in accordance with the ethical standards laid down in the declaration of helsinki.

Eligibility criteria:
inclusion criteria: * menstrual irregularity * being over 18 years of age and not distinguished by age. exclusion criteria: * another gynecological disease (pcos, endometriosis, etc.) and additional diseases (diabetes, insulin resistance, cancer, heart disease, etc.)
citrulline, exercise training and muscle strength in the elderly

Conditions: Elderly Patients

Summary: the aim of this study is to assess the effect of citrulline supplementation on muscle strength in elderly institutionalized subjects undergoing a resistance exercise training program. the primary endpoint is the outcome of maximum strength of knee extensor muscles.

maintaining muscle strength is mandatory for elderly persons to keep autonomy. resistance exercise increases muscle strength in old and very old subjects, but there seems to be little effect on muscle mass. citrulline is an amino acid that stimulates muscle protein synthesis, but its effect on muscle strength and mass remains to be determined. the aim of this study is to assess the effect of citrulline supplementation on muscle strength in elderly institutionalized subjects undergoing a resistance exercise training program. all the subjects (84) will undergo a resistance exercise training program for 12 weeks. the subjects will have a regimen of high-intensity progressive resistance training of the knee extensors 3 days per week. these muscle groups were chosen because of their importance in functional activities. the subjects will be randomized into two groups. an intervention group will receive orally citrulline at 10 g/day, and a control group will receive an isonitrogenous amount of nonessential amino acids (alanine, aspartate, glycine, serine, histidine and proline in equimolar quantity). during the 12 weeks of supplementation, clinical tolerance will be evaluated. strength testing will be repeated every two weeks for 12 weeks. the primary endpoint is the outcome of maximum strength of knee extensor muscles. fat-free mass (dexa), gait velocity, timed get up and go, spontaneous physical activity (activity monitors), nutritional status (weight, albuminemia, transthyretinemia) and quality of life will be measured at inclusion and at the end of the study. the number of falls during the study will be recorded.

Eligibility criteria:
inclusion criteria: * aged over 75 years * able to walk at least 6 meters without human assistance. exclusion criteria: * moderate to severe cognitive disorders (mmse \< 20) * severe malnutrition (bmi \ 10 % in 1 month or \> 15 % in 6 months, or albuminemia \< 30 g/l), * inflammation (crp \> 30 mg/l), * severe renal failure (creatinine clearance \< 30 ml/mn), * stage 4 cardiac failure, * respiratory failure, * corticoid treatment, * participation in another trial

Keywords: citrulline protein-energy malnutrition amino acids muscle strength resistance training
a study to investigate safety, tolerability, pk and anti-tumor activity of trx-221 in egfrm nsclc patients

Conditions: Carcinoma, Non-Small-Cell Lung; EGFR Mutant Advanced Non-Small Cell Lung Cancer

Summary: this is a phase 1/2, open-label study designed to investigate the safety, tolerability, pk, and anti-tumor activity of the study treatment in the treatment of patients with egfr mutant nsclc, who progressed following prior standard treatments which include the approved egfr-tkis with activity against t790m (e.g., osimertinib).

all eligible patients will receive the study treatment at selected oral dose(s) once daily. patients will be treated continuously until disease progression or any other pre-defined discontinuation criteria are met.

Eligibility criteria:
inclusion criteria: 1. patients with ecog performance status score of 0 or 1 2. histologically or cytologically confirmed diagnosis of relapsed or refractory, locally unresectable advanced or metastatic nsclc harboring an activating egfr mutation 3. failed standard of care treatments progressed after anti tumor treatments including at least 1 approved egfr tki \[phase2: tkis should include the approved egfr tkis with activity against t790m (e.g., osimertinib)\] 4. slots may be reserved for patients with certain resistant mutations (i.e., egfr c797x mutation with or without t790m mutation as required by the sponsor) \[phase 1\] 5. egfr c797x mutation with or without t790m mutation \[phase 2\] 6. not received more than 1 prior line of platinum based chemotherapy in the metastatic setting \[phase 2\] 7. having at least 1 measurable tumor lesion per recist v1.1 criteria \[phase 2\] 8. having adequate bone marrow, hepatic, and renal function as specified in the protocol exclusion criteria: 1. nsclc with mixed cell histology or a tumor with histologic transformation of small cell elements 2. patients having tumor with any additional known driver of alterations 3. patients with presence of another active primary malignant tumor that has been diagnosed or required therapy within 2 years prior to the initiation of the study treatment 4. patients who have unstable and symptomatic primary cns tumors/metastasis, leptomeningeal metastases or spinal cord compression which are not suitable for enrollment, as judged by the investigator 5. patients having clinically active ongoing ild of any etiology 6. clinically significant cardiac conditions, infections, refractory gi diseases as specified in the protocol 7. patients having any unresolved toxicities from prior anti tumor therapy and surgery greater than ctcae grade 1 at the time of starting the study treatment 8. recent anticancer therapy: egfr-tki, immunotherapy or any other systemic anticancer therapy or radiotherapy (specific duration prior to starting study medication per protocol)