Kornimate/medical-research-clean huggingface dataset:
a new medicine to treat nonarteritic anterior ischemic optic neuropathy (naion)

Conditions: Non Arteritic Ischemic Optic Neuropathy

Summary: determine whether dalfampridine (ampyra) can improve visual function in patients who have had nonarteritic ischemic optic neuropathy (naion) with stable visual impairment.

the aim of this study is to determine whether dalfampridine can improve visual function in patients who have had nonarteritic ischemic optic neuropathy (naion) with stable visual impairment. the objective of this double masked crossover study is to determine whether visual function can be improved in numerous parameters. this includes high contrast visual acuity, low contrast visual acuity, visual field, visual quality of life (vfq-39), electrophysiology, multi focal electro retinography (merg), visual evoked potential (vep), and structure, spectral domain optical coherence tomography (oct). based on the promising results of the use of dalfampridine in multiple sclerosis (ms) and in stroke, we hypothesize that the patients with chronic stable deficits after nonarteritic ischemic optic neuropathy (naion) will have improved visual function with the administration of dalfampridine.

Eligibility criteria:
inclusion criteria: * naion 6 months prior to enrollment * visual acuity of 20/40 or worse exclusion criteria: current use of dalfampridine (ampyra) * pregnancy * history of seizures * renal failure * not able to perform testing

Keywords: ampyra naion dalfampridine
the pharmacokinetics of single dose oral tetrahydrocannabinol and cannabidiol

Conditions: Cannabis; Chronic Kidney Diseases; Dialysis

Summary: pot-gfr-pk is a single dose pharmacokinetic study oral tetrahydrocannabinol (thc) and cannabidiol (cbd) in healthy adult controls and individuals with chronic kidney disease including those treated with in-center hemodialysis.

adults aged greater than 25 years including 6 with egfr\>60ml/min/1.73m2, 6 egfr 30-59ml/min/1.73m2, 6 egfr \<30ml/min/1.73m2 (ckd epidemiology collaboration equation) and 6 receiving in-center hemodialysis at least 2x weekly via a tunnelled catheter will receive thc 0.1mg/kg and cbd 2mg/kg by mouth in the form of medipharm labs-001 (mpl-001) (50mg cbd/2mg thc per 1ml). in healthy controls and participants with chronic kidney disease, blood samples will be collected at t=0, 1, 2, 3, 3.5 and 4 hours post thc/cbd administration. in participants receiving in-center hemodialysis, blood samples will be collected at t=0, 1, 2, 3, 3.5 and 4 hours post thc/cbd administration and during hemodialysis at t=0, 60, 120, 180 minutes and 15 minutes prior to the end of hemodialysis (at a reduced pump speed with blood flow 50-100ml/min) and 60 minutes post-hemodialysis. a 24 hour urine will be collected in all participants except those receiving hemodialysis without any residual urine output. dialysate samples will be collected at 1,2,3 hours during hemodialysis and at the end of hemodialysis. blood samples will also be collected at 24 and 48 hours. plasma, urine and dialysis cannabinoids (thc, cbd and their metabolites) will be quantified using multisegment injection-capillary electrophoresis-mass spectrometry.

Eligibility criteria:
inclusion criteria: 1. adult age\>25 years 2. estimated glomerular filtration rate (egfr)\>60ml/min/1.73m2 or egfr\ 90 days 3. agree to take the medication as directed in the study 4. provides informed consent exclusion criteria: 1. body mass index \ 35kg/m2 2. physical dependence on any drug other than caffeine or nicotine 3. history of clinically significant adverse event associated with cannabis intoxication 4. history of psychosis or mania or any active major psychiatric disorder 5. recent (within 30 days) use of any cannabinoid (natural or synthetic) identified by self-report or urine drug screen for cannabinoids 6. taking any medication with known interactions with thc or cbd via cytochrome p450 (cyp) cyp2c9, cyp2c19 and cyp4a6 or cyp2d4 (e.g. anti-epileptic drugs, calcineurin inhibitors, anti-fungal) 7. evidence of liver dysfunction (alt less than 3 times upper limit of normal, bilirubin below upper limit of normal, international normalized ratio\<1.5) 8. pregnant or breastfeeding women 9. change in ideal body weight or dry weight in the last 4 weeks 10. intradialytic hypotension (systolic blood pressure\<90mmhg) requiring an intervention in the previous 4 weeks

Keywords: pharmacokinetics
fascia iliaca compartment block for pain management in hip fracture patients

Conditions: Hip Fractures

Summary: blockpain is a randomized controlled study, 80 participants. the participants will be hip fracture patients in emergency medicine department in clinical hospital "sveti duh", zagreb, croatia. upon patient arrival inclusion and exclusion criteria will be established. after signing the informed consent form participant will be randomized in one of two study groups. one study group is fascia iliaca compartment block (ficb), the other is placebo. all participants will be given paracetamol 1 gram iv as standard care. if needed, rescue analgesic will be tramadol 100 mg in 100 ml saline iv. the time frame is 24 hours after the ficb or placebo procedure.

hip fractures in older patients are a major public health problem. for acute pain management, nonopioid analgesics are often not sufficient enough, and opioids have many adverse events. for this reasons fascia iliaca compartment block could be the treatment of choice. the objective of this study is to evaluate the efficacy of the fascia iliaca compartment block for pain management in the emergency department, especially the effect on stress response and the effect on the acute confusional state. the investigators intend to conduct a randomized clinical trial in hip fracture patients years 65 and older presenting in the emergency department. in addition to standard analgesia with parenteral paracetamol, the first group of patients will receive fascia iliaca compartment block and the second group placebo. the investigators will monitor the effect of treatment protocol on laboratory parameters of stress response copeptin and cortisol, frequency and severity of acute confusional state, pain intensity and the need for additional opioid analgesics. data obtained from this research could significantly improve the standard and quality of analgesia in the older patients with hip fracture. regional anesthesia can diminish or prevent the development of stress response and cognitive impairment and these are the factors that complicate recovery of this fragile group of patients.

Eligibility criteria:
inclusion criteria: * hip fracture after minor trauma/simple falls, confirmed by imaging technique (x-ray or ct scan or mri) * signed informed consent form (after a verbal explanation and written information sheet) exclusion criteria: * pathological fracture * head injury * body mass bellow 50 kg * cognitive impairment (abbreviated mental test score less then 6 points) * oral anticoagulant drugs * prior drug allergy (paracetamol, tramadol, local anesthetics) * prior peripheral artery bypass surgery (on the same side as hip fracture) * skin or soft tissue infection in the groin area (on the same side as hip fracture) * simultaneously bilateral hip fracture * opioid analgesics prior to hospital arrival

Keywords: hip fractures pain management
blood pressure and obstructive sleep apnea

Conditions: The Effects of Obstructive Sleep Apnea on Blood Pressure Measurement

Summary: bidirectional and causal relationship exists between obstructive sleep apnea (osa) and hypertension in a dose-response manner, independent of confounding variables such as age, smoking, and body mass index. osa is conventionally diagnosed and graded by apnea-hypopnea index (ahi). the relationship between ahi and changes of blood pressure deserves further investigation.

approximately 50% of patients with obstructive sleep apnea (osa) have hypertension; up to 30% of patients with hypertension have osa, and the prevalence is even higher in those of resistant hypertension. osa is conventionally diagnosed and graded by apnea-hypopnea index (ahi). this retrospective study aimed to determine if osa severity and ahi have effect on blood pressure measurements and the nocturnal changes following an overnight sleep.

Eligibility criteria:
inclusion criteria: (1). individuals who underwent full-night polysomnography at taipei vgh for symptoms related to obstructive sleep apnea, such as snoring and daytime somnolence; (2). feasibility to measure bp via wrist monitors; (3). confirmation of wakefulness through electroencephalography. exclusion criteria: (1). failure to measure bp via wrist monitors; (2). age younger than 18 years; (3). sleep efficiency less than 50%; (4). central sleep apnea ≥ 50%
compare the prognostic differences between sbrt and surgery for nsclc patients with interlobular fissure invasion.

Conditions: NSCLC; Radiotherapy; Surgery

Summary: the goal of this observational study is to compare the prognostic differences between sbrt and surgery for nsclc patients with interlobular fissure invasion. the main questions it aims to answer are: 1. explore the survival differences. 2. explore of the lung function changes before and after different treatments.

main purpose: explore the survival differences between sbrt and surgery for nsclc patients with interlobular pleural invasion. secondary purpose: 1. longitudinal exploration of the differences in heart and lung function changes before and after treatment between sbrt and surgery of nsclc patients with interlobular pleural invasion 2. longitudinal exploration of dynamic changes in lung lobe volume before and after treatment in nsclc patients with interlobular pleural invasion treated with sbrt and surgical intervention.

Eligibility criteria:
inclusion criteria: 1. voluntarily participate and sign an informed consent form in writing; 2. age 18 and above, regardless of gender; 3. diagnosed as primary lung cancer through imaging/pathology, meeting the indications for sbrt and surgical treatment; 4. the clinical staging is cib-iiib stage (ct2-3n0m0), regardless of whether the staging is overestimated or underestimated as confirmed by pathology; 5. imaging diagnosis of nsclc patients with tumor invasion of interlobular pleura; 6. no serious abnormalities in the blood system, heart, lungs, liver, kidney function, or immune deficiency; 7. there are no restrictions on surgical methods, and both vats and open chest surgery are acceptable; 8. physical condition score ecog level 0-2; 9. expected survival time\>3 months. exclusion criteria: 1. pathological confirmation of small cell lung cancer; 2. non solitary lung cancer, non primary lung cancer, with distant metastasis; 3. individuals with a history of severe lung or heart disease; 4. severe comorbidities, such as uncontrolled hypertension, heart failure, etc; 5. pregnant or lactating women; 6. previous history of malignant tumors; 7. refusal or inability to sign the informed consent form for participating in the trial.
open label extension study of amx0035 in patients with als

Conditions: Amyotrophic Lateral Sclerosis; ALS

Summary: this study will provide extended access to patients and assess longer-term outcomes on patients who have completed the centaur study.

the centaur open label extension study (centaur-ole) is designed to provide longer term access to amx0035 for patients with als who participated in the centaur study. the study will assess longer term safety and therapeutic potential of amx0035.

Eligibility criteria:
inclusion criteria: 1. completion of all visits in the randomized, double blind amx0035 study. subjects that receive tracheostomy or pav during the course of the main study will still be followed as itt until the week 24 visit before enrollment in the ole. 2. must enroll in the ole within 28 days of the week 24 visit of the main study. 3. signed informed consent to enter the open label extension phase. exclusion criteria: 1. discontinued study drug prematurely in the double-blind phase of the study for reasons other than tracheostomy or pav. 2. exposure to or anticipated requirement for any disallowed medication listed below. 3. any ongoing adverse events that in the opinion of the site investigator are clear contraindications to the study drug. 4. unstable cardiac or other life-threatening disease emergent during the randomized, double blind study 5. any major medical condition that in the opinion of the site investigator would interfere with the study and place the subject at increased risk.
the whole-course management of pegaspargase in enktl

Conditions: Extranodal NK/T Cell Lymphoma

Summary: this is a prospective, multi-center study of the whole-course management of pegaspargase in extranodal nk/t cell lymphoma (enktl). based on a complete population pharmacokinetic model of pegaspargase in enktl patients, the time node of asparaginase monitoring and the principle of dose adjustment will be formulated. besides, the proportion of "silent inactivation" of asparaginase in enktl patients and its effect on the prognosis of patients will also be explored. the treatment plan is as follows: (1) during 8 early (stage i/ii) enktl patients receiving p-god (peasparaginase + gemcitabine + oxaliplatin + dexamethasone) for the first time, the activity of pegaspargase in peripheral blood will be detected on d3, d4, d5, d6, d7, d8, d10, d12, d14, d16, d18 and d21. (2) during 4 early (stage iii/iv) enktl patients receiving pemd (peaspargase + etocytidine + methotrexate + dexamethasone) for the first time, the activity of pegaspargase in peripheral blood will be detected on d3, d4, d5, d6, d7, d8, d10, d12, d14, d16, d18 and d21. (3) during 72 (including above 12 patients) enktl patients receiving p-god/pemd, the activity of pegaspargase and anti-pegaspargase in peripheral blood will be detected on d9 and d16 of each cycle of treatment.


Eligibility criteria:
inclusion criteria: * pathologically confirmed first-line enktl patients according to who 2016 * willingness to provide written informed consent. exclusion criteria: * patients are unsuitable for the enrollment according to investigator's judgement.
personalized digital training intervention to reduce inflammation by correcting pathological movement patterns in pre-stage knee osteoarthritis after anterior cruciate ligament reconstruction

Conditions: Osteoarthritis (OA) of the Knee; ACL Reconstruction

Summary: osteoarthritis (oa) is a condition that causes pain and stiffness in the joints, often due to injuries like torn ligaments. even after surgery, these injuries can lead to long-term joint problems. current treatments don\&#39;t fully prevent oa from developing. this study is testing a new 12-week exercise program designed to improve how the knee moves, using a special sensor-based system. the goal is to reduce joint inflammation and prevent the development of oa in patients who have had knee surgery.


Eligibility criteria:
inclusion criteria: * signed written informed consent * underwent anterior cruciate ligament reconstruction (aclr) due to an acute knee injury in the past 12 months * aclr patients with aberrant gait profiles who exhibit all three aberrant characteristics (knee flexion angle, knee flexion moment, and knee adduction moment) exclusion criteria: * previous trauma or surgery (other than aclr) to any weight-bearing joint, * signs of knee oa as defined by the oarsi-joint space narrowing (jsn) score of two or more (standing ap x-ray) * body mass index ≥ 30 kg/m2; * inflammatory arthropathies; * immunosuppression due to illness or medication; * sepsis or hemostasis disorders; * severe uncontrolled inflammatory disease or autoimmune disease (e.g., ulcerative colitis, crohn's disease, etc.); * having malignancy and undergoing treatment including chemotherapy, radiotherapy, or immunotherapy; * unable to freely give their informed consent (e.g., individuals under legal guardianship). * currently enrolled in or has not yet completed a period of at least 5 times as the half-life time of the drug used in the previous trial since ending other investigational device or drug trial(s) * patients who are dependent on the sponsor, investigator, or study site; * pregnant or breast-feeding women or women of childbearing potential not protected by an effective contraceptive method of birth control (defined as pearl index \&lt; 1); * any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the investigator, may invalidate communication with the investigator and/or designated study personnel; * patients who are committed to an institution by virtue of an order issued by either the judicial or the administrative authorities;
erectile dysfunction in patients with non ocular behçet's disease

Conditions: Behçet Disease; Behcet Syndrome; Erectile Dysfunction

Summary: it was aimed to demonstrate whether erectile dysfunction is affected by bh pathogenesis and whether there is a relationship between erectile dysfunction and bd pathogenesis by assessing both sexual function and retinal micro-vascular blood flow in bh which may involve vessels from all calibrations and nature.

patients with factors and results that could cause sexual dysfunction will be excluded from the study.an international index of erectilefunction (iief) questionnaire will be applied to a total of 35 patients under 45 years old who met the inclusion criteria. iief's erectile function,sexual desire,sexual satisfaction,orgasmic function and general satisfaction sub parameters and optical coherence eye tomography (octa) data will compared.

Eligibility criteria:
inclusion criteria: * definitive diagnosis of behçet disease * no comorbid disease known to be associated with erectile dysfunction, including hypertension and diabetes mellitus * not overweight or obese (bmi≤25 kg/m2) * non-smokers * no alcohol and/or substance abuse * no known psychiatric disorder exclusion criteria: * prostatic disorder * medication that may influence on erectile function (antihistamines, ß-blockers, etc.) * sacroiliac joint or chronic articular involvement * family history of glaucoma

Keywords: behçet's disease erectile dysfunction
a study to investigate the safety tolerability pharmacokinetics, and pharmacodynamics of inhaled and intravenous gsk2862277 in healthy volunteers

Conditions: Respiratory Disorders

Summary: this will be a 3 part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of gsk2862277 administered via inhalation (ih) or intravenous (iv) routes in healthy subjects. part 1 of this study will involve an initial assessment of safety, tolerability and pharmacokinetics of gsk286227, via single escalating intravenous doses, compared to a predecessor molecule, gsk1995057. after completion of part 1 an interim data review will occur which will assess key comparability criteria to inform progression to part 2 of the study. part 2 of the study will involve single doses of gsk2862277 at a level predicted to be at or close to therapeutic dose levels. part 2 will investigate both intravenous and inhaled routes of administration, in sequential manner, respectively. an interim data review will also occur after completion of part 2, where all data accumulated previously will be assessed to examine appropriateness to progress to part 3. part 3 of the study will involve 5 days of repeat dosing via both inhaled and intravenous routes using the same dose administered in part 2.


Eligibility criteria:
inclusion criteria: * male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent. * healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. a subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the investigator and the gsk medical monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * subject is positive at screening for havh autoantibodies against gsk1995057 (part 1 only). * a positive pre-study hepatitis b surface antigen or positive hepatitis c antibody result within 3 months of screening * a positive pre-study drug/alcohol screen. * a positive test for human immunodeficiency virus (hiv) antibody. * exposure to more than four new chemical entities within 12 months prior to the first dosing day. exclusion criteria: * a positive pre-study hepatitis b surface antigen or positive hepatitis c antibody result within 3 months of screening * a positive pre-study drug/alcohol screen. * a positive test for human immunodeficiency virus (hiv) antibody. * exposure to more than four new chemical entities within 12 months prior to the first dosing day

Keywords: healthy volunteer tnfr1 domain antibody lung injury
pro development for anca associated vasculitis

Conditions: Wegener Granulomatosis; Microscopic Polyangiitis; Churg-Strauss Syndrome

Summary: a qualitative study using interviews with patients who have antineutrophil cytoplasm antibody (anca) associated vasculitis, to develop a patient reported outcome (pro)measure

patients with antineutrophil cytoplasmic antibody (anca) associated vasculitis (aav) have inflammation in the small blood vessels leading to involvement in different body areas, e.g., the kidneys, lungs and skin. untreated, the risk of death is over 80%; with current treatment, patients often suffer from ongoing disease activity, damage or treatment side effects which have a negative impact on quality of life. because patients with aav can have a wide range of disease features, the investigators hypothesise that general patient reported outcome (pros) measurements, may not be specific enough to describe the full impact on quality of life. the main objective of this project is to start from patients' experiences to develop a disease specific pro for patients with aav. patients diagnosed with aav will be recruited through clinics or inpatients at the oxford university hospitals (ouh) national health service (nhs) trust, or, if the patients have previously consented to be contacted about future studies, through the diagnostic and classification of vasculitis (dcvas) or the characterisation and determinants of quality of life in anca associated vasculitis (vasqol) study databases. after informed consent is obtained, individual patient interviews will be conducted; these will last for approximately one hour and will be recorded and transcribed. themes will be independently extracted and amalgamated by the researchers. approximately 25 patients with different types of ancaassociated vasculitis and varying disease duration will be interviewed until saturation, i.e., no new substantive themes emerge. these themes will then evolve into individual candidate questionnaire items. candidate items will be piloted on approximately 25 different patients with aav using questionnaires and interviews, until no further comments arise, to produce a final set of candidate questionnaire items. the duration of the study 1.5 years.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * male or female * aged 18 years or above (no upper limit). * diagnosed with granulomatosis with polyangiitis- wegeners (gpa), churg strauss syndrome (css) or microscopic polyangiitis (mpa)and fulfil either chapel hill consensus conference definitions or american college of rheumatology (acr) classification criteria. exclusion criteria: * unable or unwilling to give independent written informed consent * significant communication barrier e.g., inability to speak english * membership of the steering committee

Keywords: wegener granulomatosis microscopic polyangiitis churg-strauss syndrome antibodies, antineutrophil cytoplasmic