Kornimate/medical-research-clean huggingface dataset:
immune responses in health care personnel

Conditions: Influenza

Summary: this is an investigator-initiated 10 year long open cohort observational study, aiming to increase the understanding of the humoral and cellular immunological mechanisms of vaccination against influenza, including effects of repeated vaccination, the duration of protection, immunity against circulating viruses, as well as factors affecting the immunological responses and immunity against other vaccine preventable infectious diseases among health care personnel.

influenza vaccination is given according to the normal routine of hospital district of helsinki and uusimaa (hus) occupational health care. blood samples will be collected before vaccination, 5 weeks after vaccination and 6 months after vaccination. both the same participants and also new participants will be recruited each year. the analysis will be mainly descriptive.

Eligibility criteria:
inclusion criteria: * members of health care or laboratory personnel in hus having decided to take the seasonal influenza vaccination by the routine occupational health care service * general good health as established by or volunteer's own statement * written informed consent * presumably able and willing to participate in the study during the starting influenza season exclusion criteria: * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * administration (longer than 14 days) of immunosuppressants or other immune- modifying drugs within 6 months before the vaccination; oral corticosteroids in dosages of 20 mg/day or more prednisolone or equivalent are excluded; inhaled or topical steroids are allowed. * pregnancy or lactation * acute disease at the time of enrolment (defined as the presence of a moderate or severe illness with or without fever) * contraindication for influenza vaccination * any other criteria which, in the investigator's or dedicated study staff member's opinion, would compromise the ability of a subject to participate in the study, a subject's well-being, or the outcome of the study

Keywords: influenza vaccination health care workers immune responses humoral immunity cellular immunity
atacicept in subjects with active lupus nephritis (compass)

Conditions: Lupus Nephritis (LN)

Summary: the objective of the study is to evaluate the effect of atacicept compared to placebo on changes to renal response in adult subjects with ln.

the study will assess atacicept vs. placebo on the impact of renal function. safety and patient reported outcomes will be clinically assessed. the clinical study is comprised of a 104 week double-blind treatment period, followed by a 52 week open-label treatment period and a 26 week safety follow-up period.

Eligibility criteria:
key inclusion criteria: 1. male or female at least 18 years of age at time of signing consent 2. must have the ability to understand and sign and date a written informed consent form 3. diagnosis of sle 4. biopsy- proven active ln 5. requires high-dose corticosteroids and immunosuppressive therapy for the treatment of active ln 6. subject is willing to take oral mmf for the duration of the study key exclusion criteria: 1. egfr of ≤30 ml/min/1.73 m2. 2. sclerosis in 50% of glomeruli on renal biopsy. 3. evidence of rapidly progressive glomerulonephritis. 4. currently requiring renal dialysis or expected to require dialysis during the study. 5. serum igg \<7 g/l 6. active infection or high infectious risk

Keywords: systemic lupus erythematosus (sle) estimated glomerular filtration rate (egfr) protenuria
phase i orally administered 14c-azd2171 in patients with solid metastatic tumors

Conditions: Advanced Solid Metastatic Tumor

Summary: open, non-randomised, radiolabelled, single centre study with a total of six patients with solid metastatic tumors to determine the rates and routes of elimination of 14c-azd2171 and its metabolites.


Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic tumor which is refractory to standard therapies * life expectancy is 12 weeks or longer * who performance status is 0-12 exclusion criteria: * radiotherapy and chemotherapy within 4 weeks before the start of the study treatment * patients with a history of poorly controlled hypertension * history or evidence of any medical condition that might affect gastrointestinal function * patients that have participated in a radiolabelled study in the last 5 years

Keywords: phase i azd2171 solid tumor metastatic tumor
outcomes of carbohydrate loading paediatric patients preoperatively for tonsillectomy and adenoidectomy

Conditions: Postoperative Pain; Postoperative Nausea; Satisfaction; Sleep; Postoperative Complications

Summary: randomised control trial of 150 paediatric patients aged between 3-8years. one group will receive a preoperative carbohydrate oral drink and the other group will receive current standard care (no drink) prior to undergoing tonsillectomy and/or adenoidectomy. outcomes to be reported will be: 1) patient and parent satisfaction; 2) post operative pain score at: recover, 1 hour post op, prior to discharge home and then day 1 postoperatively; 3) ponv rates in recovery, prior to discharge home and again on day 1 postoperatively; 4) sleep quality night after surgery.

children undergoing tonsillectomy and/or adenoidectomy will be consented via parents prior to the day of surgery and then randomised to 1 of 2 groups who will either receive the intervention or current standard care. patients will be recruited from the ent outpatient clinics in conjunction with the ent surgeons. data collection will be undertaken with the aid of experience research assistants.

Eligibility criteria:
inclusion criteria: * undergoing tonsillectomy and/or adenoidectomy * consented to undertake preop carbohydrate drink and follow up procedures exclusion criteria: * increased risk of aspiration or unable to swallow liquids * outside age range * non-consent to undertake treatment or follow up
nerve transfers to restore hand function in spinal cord injury

Conditions: Quadriplegia; Spinal Cord Diseases; Spinal Cord Injuries

Summary: this study seeks to evaluate the efficacy of nerve transfers in restoring hand function in patients with cervical spinal injuries.

cervical spinal cord injury is a life-altering injury that results in profound loss of upper limb function. hand function is essential to basic activities of daily living and consequently has a significant impact on patients' quality of life. tendon transfers and/or tenodesis have traditionally been used to restore hand function in spinal cord injuries - however, in recent years there is growing interest in the role of nerve transfers as a means of accomplishing this goal. although preliminary results indicate nerve transfers may be well-suited for patients with spinal cord injury, their long term efficacy has not been demonstrated. this study seeks to evaluate the efficacy of nerve transfers in restoring hand function in patients with cervical spinal injuries. eligible patients will receive nerve transfer procedure(s) (e.g. brachialis to anterior interosseous nerve, supinator to posterior interosseous) and will be followed post-operatively to assess for changes in strength, functional independence, and quality of life.

Eligibility criteria:
inclusion criteria: * patients with a spinal cord injury ais level c5 to c7. those with motor complete injuries (ais a or b) will be considered for surgical intervention if they are ≥ 5 months post injury. motor incomplete patients (ais c or d) will be considered if they are ≥ 1.5 years post injury. * patients will require ≥ mrc 4 strength of the muscle supplied by the donor nerve (e.g. brachialis, supinator). * finger flexor and extensor strength should be ≤ mrc 1 strength. * muscles supplied by the donor nerve, will need to have no or minimal of evidence of lower motor neuron injury as dictated by evidence of fibrillations, positive sharp waves, or moderate or severely decreased recruitment on needle electromyography. * those being evaluated for surgery outside nine-months post injury recipient muscles will be required to be free of lower motor neuron pathology. * ability to comply and participate in rigorous post-surgical therapy regimen. exclusion criteria: * comorbidities precluding safe surgery including autonomic/hemodynamic instability, pulmonary instability, active infection, chronic pressure sores or untreated urinary tract infections as determined by physician. * simultaneous tendon transfer or tenodesis surgery (which would preclude separation of the effect of nerve transfer alone).

Keywords: peripheral nerves quadriplegia nerve transfer surgical procedures, operative hand upper extremity quality of life
clinical trial of the use of ketamine in treatment resistant depression

Conditions: Depressive Disorder, Treatment-Resistant

Summary: the purpose of this study is to determine the efficacy of the use of intravenous low-dose ketamine in the treatment of treatment-resistant depression (trd), as well as the changes in glutamate neurotransmission and inflammatory serum markers.

the purpose of this study is to determine the efficacy of the use of intravenous low-dose ketamine (0.5 mg/kg) in the treatment of treatment-resistant depression (trd), as well as the changes in glutamate neurotransmission measured by magnetic resonance imaging spectroscopy and inflammatory serum markers (il-6, tnf-alpha).

Eligibility criteria:
inclusion criteria: * treatment-resistant depression (failure to respond to two or more trials of antidepressant monotherapy or failure to respond to four or more trials of different antidepressant therapies) * acceptance of participation via the informed consent exclusion criteria: * psychiatric comorbidity (except anxiety related disorders) * substance abuse or dependence in the previous 3 months * evidence of structural abnormalities in brain imaging * pregnancy * previous hypersensitivity to ketamine * heart failure or insufficiency * familial or personal history of psychosis * glaucoma * major neurological disease * uncontrolled systemic arterial hypertension * mri contraindications * non-acceptance of participation via informed consent

Keywords: ketamine treatment-resistant depression spectroscopy neuroinflammation
familial atherosclerosis treatment study

Conditions: Cardiovascular Diseases; Coronary Arteriosclerosis; Coronary Disease; Heart Diseases; Myocardial Ischemia

Summary: to compare the effects of two intensive lipid-lowering regimens with conventional therapy on coronary atherosclerosis as assessed by arteriography.

background: for several decades, clinical trials have addressed the question of whether treatment of hyperlipidemia reduces the risk of cardiovascular events. substantial evidence supports the idea that cardiovascular benefits are related to the degree of reduction in low-density lipoprotein cholesterol level and perhaps to the degree of increase in the high-density lipoprotein cholesterol level. in these trials, changes in lipid levels have usually been small and the overall clinical benefits have been limited. the appearance in the 1980s of more effective treatments for hyperlipidemia, new arteriographic methods for assessing atherosclerosis, and new insights into atherogenesis permitted an objective investigation into whether the progression of atherosclerosis was retarded or reversed by lipid-lowering agents. the clinical trial was supported by a subproject within a program project grant. design narrative: randomized, double-blind, placebo-controlled. baseline arteriograms were performed and fasting lipid samples drawn before heparinization. patients were stratified for age below 45 years, cigarette smoking within the previous month, and lipid patterns including familial hypercholesterolemia and triglyceride levels. patients were given dietary counseling and randomly assigned to one of three treatments: lovastatin (20 mg twice a day) and colestipol (10 g three times a day); niacin (1 g four times a day) and colestipol (10 g three times a day): or conventional therapy with placebo (or colestipol if the ldl cholesterol level was elevated). the primary endpoint was a measure of change in the severity of disease in the proximal coronary arteries as measured by quantitative arteriography.

Eligibility criteria:
inclusion criteria: * men * age 62 or younger * elevated apolipoprotein b levels * coronary atherosclerosis * family history of coronary heart disease. exclusion criteria: * diabetes * severe hypertension * cancer * liver disease * thyroid disease * kidney disease
nerve composition of human lumbar dorsal primary rami and its medial branch

Conditions: Lumbar Facet Arthrosis; Nerve Degeneration

Summary: the purpose of the study is to understand the composition of the nerves supplying the facet joints in low back.

after written informed consent, the nerves supplying the facet joints - lumbar dorsal rami and its medial branches, will be harvested when they are exposed during spinal surgery. these nerves will be fixed, washed and further dissected to enable smaller sections. the cut section will be stained and subjected to analysis of overall cross-sectional area and presence of connective tissue sheaths under light microscope.

Eligibility criteria:
inclusion criteria: * be aged 18 or over * be able to give informed consent * scheduled to undergo lumbar spinal surgery exclusion criteria: * children under 18 years old * vulnerable adults * adults with incapacity * inability to provide informed consent * history of previous spinal surgery * history of previous rf ablation for low back pain * has covid-19 or displaying symptoms of covid-19
antihistamines in eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: researchers are assessing the safety and effectiveness of antihistamines in the treatment of eosinophilic esophagitis.

the purpose of this research is to determine if antihistamines are safe and effective for the treatment of eosinophilic esophagitis. antihistamines are frequently used for the treatment of gastroesophageal reflux disease and allergic disorders, and we hypothesize they will be effective in the treatment of eosinophilic esophagitis as well. the two antihistamines used in this study are loratadine and famotidine.

Eligibility criteria:
inclusion criteria: * patients over the age of 18, male and female. * patients who carry the diagnosis of eosinophilic esophagitis (eoe) based on esophageal biopsies obtained within 6 months prior to enrollment (\>15 eosinophils per hpf on at least 2 esophageal levels) * subjects must be able to give appropriate informed consent exclusion criteria: * not willing or able to sign consent. * patients who have used topical or systemic corticosteroid therapy for any reason in the previous 6 weeks. * patients who have been treated with acid-suppressing medications (ppi or h2 receptor antagonists) in the previous 6 weeks. * patients on immunosuppressive or immunomodulating medications in the previous 6 weeks. * patients with known allergies or hypersensitivity to anti-histamines. * patients who have contraindications to the procurement of esophageal biopsies including patients who have known bleeding disorders, a history of bleeding diathesis, or who are currently using warfarin or clopidogrel. * patients who have a contraindication to the performance of an esophagogastroduodenoscopy (egd) including previous cardiopulmonary arrest during an endoscopic procedure. * patients who are pregnant.
clinical epidemiology and characteristics of covid-19 cases occurred in a lymphoma setting in the first epidemic phase (lymphocov1)

Conditions: COVID; Lymphoma

Summary: the main objective of this retrospective clinical epidemiology study is to describe the characteristics of covid-19 cases requiring hospitalization in adult patients with lymphomas during the initial phase of the epidemic (from 01/03/20 to 30/04/20). the specific objectives are to estimate the frequency of severe forms of covid-19 and those requiring intensive care hospitalisation, as well as the mortality related to the epidemic among the active file of patients followed for lymphoma at each study site, to investigate whether certain chemotherapy and/or immunotherapy treatments seem to be associated with severe forms or prolonged evolutions of covid-19, to describe possible atypical clinical forms among the population of patients treated for lymphoma. translated with www.deepl.com/translator (free version)

i methods : * multicentric retrospective observational epidemiological study based on the collection of data from patient records. * selection of voluntary hospital sites in regions with excess mortality during the epidemic phase. * systematic identification of covid-19 cases from coding data (pmsi) from the medical information departments which will be compared with the numbers of patients followed for lymphoma in the haematology departments of each site during the 6 months preceding the epidemic, identified through the pmsi. * establishment of an ad hoc crf for cases only with collection of clinical data concerning lymphoma and covid-19 and routine biological data: cytopenia (and in particular depth of lymphopenia), hypogammaglobulinemia, inflammatory markers. * estimated total number of sites: 10-15 and number of cases to be collected: 50-60. translated with www.deepl.com/translator (free version)

Eligibility criteria:
inclusion criteria: * patients at least 18 years of age with lymphoma and a diagnosis of covid-19 requiring hospitalization. * in order not to bias the data by excluding patients with adverse outcomes, we will also collect data from deceased patients. exclusion criteria: patients who refused to participate -

Keywords: covid lymphoma epidemiology
access to nutritional services and the effect on maternal weight gain

Conditions: Pregnancy; Obesity

Summary: the purpose of this study is to evaluate the effect of access to nutrition services on pregnancy outcomes in the obese urban population. there are many studies that have shown that obesity has a negative impact on pregnancy. however, currently there are only a few small studies that specifically look at ease of access to nutrition services in an obese urban population and the effect this has on maternal weight gain and pregnancy outcomes. this study will compare two groups of pregnant women with a bmi of 30 or greater. the investigators hypothesize that access to nutritional services will lead to decreased weight gain during pregnancy and improved pregnancy outcomes.

the purpose of this study is to evaluate the effect of access to nutrition services on pregnancy outcomes in the obese urban population. approximately one fourth of women in the united states are overweight and nearly one third are considered to be obese. pregnancy places obese women at increased risk for several adverse events in the antepartum, intrapartum, and postpartum period. there are many studies that have shown that obesity in pregnancy has a negative impact on pregnancy. however, currently there are few studies in the united states that specifically look at ease of access to nutrition services in an obese urban population and the effect this has on pregnancy outcomes. this study will be a randomized controlled study that will compare two groups of pregnant women with a bmi of 30 or greater one of which has access to nutritional services along with routine prenatal care while the other gets only routine prenatal care. the investigators hypothesize that the obese parturient who has access to nutritional services will have decreased weight gain during pregnancy and ultimately have improved pregnancy outcomes. this will help to guide future care for the obese parturient in the urban population who may have limited access to services.

Eligibility criteria:
inclusion criteria: * primigravid women * age 19-40yrs * less than or equal to 18 weeks gestation at time of enrollment * body mass index (bmi) greater than or equal to 30 exclusion criteria: * multiparous women * less than 19 yrs of age or older than 40 * greater than 18 weeks gestation at time of enrollment * body mass index (bmi) less than 30 * any significant past medical history including hypertension, diabetes, renal disease, coagulopathy * past surgical history of gastric bypass/weight loss surgery

Keywords: pregnancy obesity nutrition therapy
safety of ganfort® ophthalmic solution in chinese patients with open-angle glaucoma or ocular hypertension

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: a study to evaluate the long-term safety of ganfort® (bimatoprost 0.03% plus timolol 0.5%) in chinese patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blocker or prostaglandin analogues.


Eligibility criteria:
inclusion criteria: * diagnosis of open-angle glaucoma or ocular hypertension that is insufficiently responsive to topical beta-blockers or prostaglandin analogues in one or both eyes * is willing to stop other intraocular pressure (iop)-lowering medications and switch to ganfort® as a single agent in affected eye(s). exclusion criteria: * reactive airway disease including bronchial asthma or a history of bronchial asthma or severe chronic obstructive pulmonary disease * sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block, not controlled with pacemaker. overt cardiac failure, cardiogenic shock.
comparison of the efficacy of ultrasound-guided greater occipital nerve block and pulsed radiofrequency therapy in chronic migraine patients

Conditions: Chronic Migraine, Headache

Summary: chronic migraine (cm) is related to headache-related disability and reduced quality of life. therefore, patients with cm require preventive treatment. the aim of this double-blind, comparative-effectiveness study was to compare ultrasound-guided great occipital nerve (gon) block and pulsed radiofrequency (prf) application in cm patients. the study consisted of 2 groups: gon block (group gonb) and gon block + pulsed rf (group gonb+prf). each group had 16 patients. ultrasound-guided gonb was performed to locate the nerve more accurately. with 0.5 hz sensorial stimulation, a 5-cm-long radiofrequency needle was advanced under ultrasound guidance in both groups. gon block was performed in all patients by administering 5mg bupivacaine through a prf needle. after the gon block, the prf neuromodulation was applied at 42 degrees for 4 minutes in the gonb-prf group. in the gonb group, no pulse was given. the patients were examined for follow-ups at the 1st, 2nd, 3rd, and 6th months after the procedure. the severity and the number of migraine attacks, and the number of analgesic drugs were noted.


Eligibility criteria:
inclusion criteria: * age 18-65; * ichd-3 defined chronic migraine exclusion criteria: * patients who had been started on an effective preventive medication within the past three months; * medication-overuse headache; * treatment with peripheral nerve blocks, trigger point injections or botulinum toxin injections within the past three months; * known allergic reaction to local anaesthetics; * pregnancy or nursing; * history of another headaches; * history of chronic medical conditions (e.g. cardiovascular, hepatic, renal, endocrine); * history of other chronic pain syndromes (e.g. low back pain and fibromyalgia).