Kornimate/medical-research-clean huggingface dataset:
detection of latent tuberculosis in hemodialysis patients

Conditions: Chronic Renal Failure

Summary: this study aims to compare the performance of the tuberculin skin test, used for more than 50 years as a diagnostic tool for latent tuberculosis infection, with 2 blood tests which have recently become commercially available (interferon-gamma release assays) in a population of immunosuppressed individuals with chronic renal failure undergoing long term hemodialysis

this prospective study includes all adults aged over 18 years of age who accept to be included in the study and provided written informed consent. all patients are under long term hemodialysis for chronic renal failure. they are subjected to a questionnaire including history of contacts with tuberculosis (tb), prior treatment for tb, history of prior tuberculin skin testing, history of bcg vaccination, country of origin, trips or prolonged stays in high incidence areas, smoking history, and medications. all patients will have a chest x-ray, and simultaneous testing with the tuberculin skin test according to the mantoux technique, and with the t-spot. tb and quantiferon gold in tube interferon-gamma release assays. the study analysis agreement between tests, detection of prior tb and presumptive latent tuberculosis infection, based on these items.

Eligibility criteria:
inclusion criteria: * adults aged over 18 * under hemodialysis for \> 3 months * end stage renal failure exclusion criteria: * refusal to participate * prior tuberculin skin test \> 15 mm or any adverse reaction to tuberculin skin test

Keywords: hemodialysis end stage renal failure tuberculosis latent tuberculosis infection patients under hemodialysis for end stage renal failure
retrospective medical chart review study to describe the experience of sle patients treated with anifrolumab in the early access programs.

Conditions: Systemic Lupus Erythematosus

Summary: the erythro study is a retrospective medical chart review study of patients in the amana and atuc early access programs (eaps) across a number of countries, to assess anifrolumab usage and patient experience in treating sle in a real-world setting. since patient safety data are already collected and reported according to regulatory requirements through eaps, this study will not collect safety data.

this is a multi-country, multi-site retrospective chart review study that will use data extracted from the medical charts of sle patients who participated in the anifrolumab eaps amana or atuc in france, germany, greece, israel, italy, portugal, spain, and the uk. patient level data will be captured longitudinally for each patient over a 12- to 18-month period. the study period will include retrospective data collection covering a minimum 6- month baseline period prior to the index date and retrospective data collection covering a minimum 6-month fu period from the first anifrolumab infusion. the index date is defined as the date of first anifrolumab infusion during the indexing period. the indexing period is between the earliest date of patient enrolment into the eap and the date of last new patient enrolment into eap. the eaps have closed by end of february 2023 in all countries included in the erythro study. one data extraction will be performed per patient.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years at time of enrolment into amana or france atuc program, and * have at least 6 months of data from medical charts available prior to the initiation of anifrolumab through the eap, and * have been initiated on anifrolumab at least 6 months before enrolment into erythro study, and * informed consent obtained (where required as per country regulations) to participate in erythro exclusion criteria: * participated in anifrolumab clinical trials, nct02794285 (d3461c00009) and / or nct01753193 (d3461c00003), prior to enrolment into amana or france atuc program, or * participated in any sle clinical trial during the baseline period and / or the fu period of erythro, or * patients who were pregnant during the baseline period and / or the fu period of erythro

Keywords: chronic autoimmune disease immunosuppressants corticosteroids human monoclonal antibody (igg1ƙ mab) real world
omalizumab weight-based dosing efficacy trial

Conditions: Allergies; Food Allergy

Summary: this research is being conducted to assess the safety and effectiveness of increased dosing of omalizumab for food allergies.

this research is being conducted to assess the safety and effectiveness of omalizumab for food allergies dosed differently from what is currently fda approved. the study hypothesizes the current way of dosing omalizumab may not work well for all patients with food allergy and it unnecessarily excludes some individuals with very high allergic antibody (ige) who may benefit. this study will include subjects regardless of ige level. one of the goals is to learn more about how safe and effective omalizumab is for people with these high ige levels, since this has not been fully studied before.

Eligibility criteria:
inclusion criteria: * a positive prick skin test (pst) with a wheal ≥ 6 mm to at least two of the relevant foods (peanut, cashew, walnut, egg, or milk) * positive food specific ige (≥2.0 kua/l) to at least two of the relevant foods * a positive history of clinical reaction to at least one of the qualifying foods other than the challenge-qualifying food (if meeting above criteria): * positive oral food challenge (ofc) to one of the potentially qualifying foods at a cumulative dose of ≤144 mg (maximum tolerated dose ≤30 mg) exclusion criteria: * weight \>80 kg at time of screening * clinically significant laboratory abnormalities at screening. * sensitivity or suspected/known allergy to any ingredients (including excipients) of omalizumab. * poorly controlled or severe asthma/wheezing at screening * history of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise, picu admission f for continuous epinephrine for hypotension or severe respiratory compromise requiring intubation. * treatment with a burst of oral, intramuscular (im), or intravenous (iv) steroids of more than two days for an indication other than asthma/wheezing within 30 days of screening. * currently receiving oral, im, or iv corticosteroids, tricyclic antidepressants, or β-blockers. * past or current history of eosinophilic gastrointestinal disease within three years of screening. * past or current history of cancer, or currently being investigated for possible cancer. * past or current history of any food immunotherapy (e.g., oit, slit, epit) within 6 months of screening. * treatment with monoclonal antibody therapy, or other immunomodulatory therapy within 6 months of screening. * inability to discontinue antihistamines for minimum wash-out periods required for spts or ofcs. * pregnant or breastfeeding or intending to become pregnant during the study. * evidence of clinically significant chronic disease.

Keywords: omalizumab
a study reviewing medical records to learn more about treat-and-extend with eylea in patients with neovascular age-related macular degeneration (namd).

Conditions: Neovascular Age-related Macular Degeneration

Summary: in people with neovascular age-related macular degeneration (namd), the body makes too much of a protein called vascular endothelial growth factor (vegf). this causes too many blood vessels to grow in a part of the eye called the macula. these blood vessels can damage the macula, causing dark spots and blurriness in central vision. the study drug, aflibercept, works by reducing vegf levels in the eye.it has already been approved for patients to receive as a treatment for namd in a fixed 8-weekly or treat-and-extend dosing regimen after having received 3 monthly doses at the start of treatment. in this study, the researchers want to learn more about how often patients received aflibercept and how their vision changed. the study will include patients with namd who had not received treatment to reduce vegf levels in the eye before. these patients will have started treatment with aflibercept between january 2016 and november 2018. the study will include about 330 men and women who are at least 18 years old. all of the patients had received aflibercept eye injections based on their doctor's instructions. the researchers will use the patients' medical records from january 2016 to november 2020 to measure the following: * the number of aflibercept eye injections the patients received * how long the patients could wait between treatments * the change in the patients' vision * how many patients stopped treatment and why. * associations between patient and disease characteristics at the start of treatment with the number of aflibercept injections and patient's vision during treatment.


Eligibility criteria:
inclusion criteria: * adult (≥18 years) patients diagnosed with namd * anti-vegf treatment-naïve * started intravitreal (ivt) aflibercept treatment between 01 january 2016 and 30 november 2018 * aflibercept treatment according to treat-and-extend (t\&e) immediately after the loading dose * availability of medical records of aflibercept treatment. exclusion criteria: * participation in an investigational program with interventions outside of routine clinical practice during the aflibercept treatment * patients with eye diseases that required surgery during the first 24 months of aflibercept treatment, e.g. advanced glaucoma, visually significant cataracts.

Keywords: retinal disorders aflibercept treat-and-extend
surgical treatment of pelvis in fragility fracture in germany: a prospective, national, multicenter, observational, comparative cohort study comparing isolated posterior versus combined anterior-posterior surgical fracture stabilization

Conditions: Pelvis; Fracture

Summary: over a period of approximately two years, patients above the age of 65 who have suffered from an ffp equal to or higher than type iic ffp, according to rommens and hofmann, will be eligible for inclusion. at least 420 patients will be included and followed up up for 12 months. treatment and postoperative care, will be as per standard of care at the participating institution, with a free choice of isolated posterior or combined anterior-posterior surgical treatment. pain levels, quality of life, level of mobility and independence will be assessed at different time points. furthermore, both clinical and radiographic outcomes, complications, morbidity and mortality associated with interventions will be evaluated. assessment and evaluation will be performed at defined time points during fu according to standard of care.


Eligibility criteria:
inclusion criteria: * patients with sacral ffp (no concomitant injuries) types: iic, iiic, ivb, ivc according to rommens and hofmann associated with fracture of the anterior pelvic ring (fractures involving the anterior lip of the acetabulum that are not regarded as acetabular fracture will be included) * diagnostic workup for fracture diagnosis and classification performed using ct scan as per standard of care * indication for surgical fracture fixation as considered by the attending surgeon * age ≥ 65 yrs. * low-energy trauma fracture, or osteoporotic fracture, or insufficiency fracture, or spontaneous fracture * asa-score ≤ 3 pts. * ability to provide informed consent according to the irb/ec defined and approved procedures exclusion criteria: * patients with multiple fractures * instability of the pubic symphysis (ie, visibility of a widening or diastasis of the symphysis), and/or fractures of the pubic rami next to the symphysis, that indicate instability * pelvic fractures due to high-energy trauma * pathologic fractures (eg, fractures caused by malignancy or infection) * history of pelvic fracture or pelvic ring surgery (hip joint implants do not count) * clinically significant or unstable medical or surgical condition that prevents surgical treatment

Keywords: pelvis fragility fracture classification management operative outcome
empirical comperative study of variation blood level antibody vitamin d at different groups of patients compared healthy peoples

Conditions: Vitamin D Deficiency

Summary: the aim of this study is to detect antibodies to vitamin d in the serum at different groups of patients and healthy volunteer. a second goal is to find the relation between vitamin d antibody and vitamin d level.

vitamin d and its metabolites have a significant role in the calcium homeostasis and bone metabolism. vitamin d deficiency as measured by serum 25(oh)d below 20 ng/ml (50 nmol/l) may contribute to the development of osteoporosis and osteomalacia. several studies have clearly demonstrated that low 25(oh)d levels are associated with more comorbidities, higher estimated cardiovascular risk and autoimmune diseases. exposure to the ultraviolet (uv) rays in sunlight is the major source of vitamin d. other sources are dairy products enriched with vitamin d. vitamin d deficiency can result from inadequate exposure to sunlight, malabsorption including inflammatory bowel disease, celiac disease and patients undergone resection of the small intestine and inadequate intake of dairy products enriched with vitamin d. another possible explanation for vitamin d deficiency is the presence of neutralizing autoantibodies to vitamin d. the aim of this study is to detect antibodies to vitamin d in the serum at different groups of patients and healthy volunteer at least 64 blood samples of patients and healthy volunteer will be tested for the presence of auto-antibodies using an elisa reader. the result will compare antibody-positive and antibody-negative individuals with respect of serum 25(oh)d level and other variables and to find the relation between vitamin d antibody and vitamin d level.

Eligibility criteria:
inclusion criteria: 1. patients treated in meir medical center 2. data on serum vitamin d values 3. 18 years old 4. both sexes 5. patient hereby declare that he\\she agree to participate the clinical trial exclusion criteria: 1. patient refuses to sign informed consent. 2. patients without vitamin d values
use of apheretic technologies in cardiovascular disease

Conditions: Dyslipidemia

Summary: to evaluate the effects of h.e.l.p. apheresis on lipid profile, lp(a) level, and some inflammatory adypocytokines in patients with high cardiovascular risk.


Eligibility criteria:
inclusion criteria: * high lp(a) not responsive to diet and pharmacological treatment exclusion criteria: * heart failure * hepatic failure * renal failure

Keywords: high level of lp(a)
educational intervention targeting nurses attitudes and knowledge about cancer-related pain management

Conditions: Neoplasms

Summary: the purpose of this study is to investigate whether an intervention consisting of the implementation of guidelines about daily systematic pain assessment following a theory based education, targeting cancer-related pain and pain treatment, lead to a significantly positive improvement in rns knowledge of, and attitudes towards their pain management. furthermore will the interventions targeting the rns influence the admitted patient's perception of their cancer-related pain?


Eligibility criteria:
inclusion criteria: * cancer diagnosis * aged 18 years and above * cognitively intact and able to verbally communicate * at admission pain intensity \>1 on visual analogue scale (vas) exclusion criteria: * trauma or planned and/or acute surgery.
the effect of topical imipramine on photodynamic therapy-mediated immunosuppression on forearms on us veterans

Conditions: Actinic Keratosis; Imipramine; Photodynamic Therapy

Summary: the purpose of this study is to test the use of topical imipramine in combination with topical photodynamic therapy's (pdt) effect on immunosuppression following treatment. pdt is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis or "ak") on their skin. these are both fda-approved medications, but this study is evaluating their use in combination, which has not been evaluated in the past. the investigators have been doing studies using mice that suggest imipramine might reduce immune system suppression by pdt thus allowing it to work better. subjects whose provider has decided that they may benefit from pdt to treat their skin due to many ak precancerous lesions will be recruited for this study. please note that the pdt itself is not experimental, only the imipramine treatment to the skin. there is a separate informed consent for the pdt.


Eligibility criteria:
inclusion criteria: * adult males and females ages 18 and older who are patients at the dayton vamc dermatology clinics * skin type must be "fair", fitzpatrick type i or ii, due to the presence of actinic damage in this population. * subjects must have a va physician's order to receive pdt treatment on their forearms. * willing to participate and understand the informed consent document. * willing to avoid excess sun exposure/tanning beds to the area to be treated with pdt. * has stable transportation to attend study visits at dva exclusion criteria: * currently taking any tricyclic antidepressants (tcas) * currently taking any selective serotonin reuptake inhibitor (ssri) * has porphyria * large tattoos in areas to be tested * pregnancy or nursing * taking any oral or topical medications that could interfere with the pdt * active rashes in the areas
gon-injection for a sooner and better treatment of cluster headache

Conditions: Cluster Headache, Episodic; Greater Occipital Nerve Injection

Summary: cluster headache is a very severe primary headache disorder. in episodic cluster headache, attacks occur in 'bouts' (clusters) lasting weeks to months. management of cluster headache entails a combination of attack and prophylactic treatment. current first choice prophylactic treatment (verapamil) has considerable side effects which can be serious and include possibly fatal cardiac arrhythmias; and it can take weeks to titrate to an effective dose. evidence has emerged that local steroid injection of the greater occipital nerve (gon) may be effective in cluster headache, but this method has not been investigated as a first line prophylactic treatment in a large, well-documented group of episodic cluster headache patients who are still free of prophylactic medication and just entered a new cluster headache episode. as such, gon-injection has not yet found its way into current treatment protocols. the investigators plan to perform this multicentre double-blind randomized controlled trial to investigate whether gon-injection is efficacious as a first-line prophylactic treatment, aiming to remove the need for high doses of daily medication - such as verapamil - with associated side effects.


Eligibility criteria:
inclusion criteria: * patients have to be diagnosed with episodic cluster headache according to the international classification of headache disorders - third edition, ichd-3 * patients have to be aged 18-65 years * patients need to be newly diagnosed and treatment naïve, or already diagnosed and currently free from prophylactic treatment * patients need to have a mean of 1 or more attacks per day in the 3 days preceding inclusion. * patients should be in their cluster period for shorter than 4 weeks before inclusion. exclusion criteria: * a contraindication for treatment with steroids or verapamil * the use of anticoagulants or known bleeding disorder. * use of any prophylactic medication for cluster headache * patients with a history of other primary headache who are currently using prophylactic medication for this headache * pregnancy
clinical validation of a combinatorial pharmacogenomic approach in major depressive disorder

Conditions: Major Depressive Disorder

Summary: major depressive disorder (mdd) is a common, chronic, debilitating mood disorder causing serious functional impairment and significantly decreased quality of life. pharmacotherapy represents the first-line treatment choice; however, only about one third of patients respond to the first trial because of antidepressants ineffectiveness or side-effects. this causes suffering for patients and their families and significantly contributes to pushing up costs for healthcare services. precision medicine in psychiatry might offer to clinicians the possibility to tailor the treatment according to the best possible evidence of effectiveness and tolerability for each subject. in this context our study aims to carry out a clinical validation of a combinatorial pharmacogenomics (pgx) test in an italian mdd patient cohort with an advocacy license independence. our study is a prospective single-blind randomized controlled clinical observational trial enrolling 300 mdd patients. patients referred to psychiatric services due to the failure and/or the onset of adverse effects of their current treatment for receiving a new antidepressant. eligible participants with a primary diagnosis of mdd according to dsm-5 criteria and a hamilton depression rating scale (ham-d17) with a score \> 14 are randomized to tgtg group (treated with genetic test guide) or tau group (treated as usual). for all subjects, buccal brush for dna is collected. the primary outcome is the reduction in depressive symptomatology as measured by ham-d17. the secondary outcomes involve a range of scales that assess mdd symptoms and social functioning outcomes. the assessment is performed at four timepoints: baseline and 4, 8, and 12 weeks. this project represents the first randomized controlled clinical trial in which is tested whether a non-commercial pgx test improves outcomes in a mdd naturalistic cohort. moreover, the identification of new genetic variants associated with non-response or side effects will improve the efficacy of the test leading to a further cost-saving.


Eligibility criteria:
inclusion criteria: * a current diagnosis of unipolar depression according to diagnostic and statistical manual of mental disorders-5 (dsm-5) * an hamilton depression rating scale (hamd-17) score \>=14 * caucasian ethnicity. exclusion criteria: * cognitive impairment (mini mental state examination mmse \<24) * neurological disorders * diagnosis of mdd with psychotic features, bipolar i and ii disorders, schizophrenia spectrum and other psychotic disorders, obsessive-compulsive disorder, post-traumatic stress disorder * substance abuse in the last 3 months * comorbidity with personality disorders (cluster a and/or b); pregnancy * comorbidity with other severe medical illness.