Kornimate/medical-research-clean huggingface dataset:
human leishmaniasis: antigen recognition pattern and study of new potential biomarkers

Conditions: Leishmaniasis

Summary: this is an exploratory experimental multicentre study on archived serum samples and on prospectively collected serum samples and blood samples. general objectives of the study are: to identify specific biomarkers in order to develop more accurate serological tests for the screening of leishmania infections that does not present cross-reaction with other infectious diseases; to unveil the antigen recognition patterns (arps) of leishmania infection in humans; to verify whether the arps and the new biomarkers are common to different leishmania infantum strains isolated in italy as well as in other part of the world and to different strains of l. donovani isolated in sudan as well as in other part of the world and discard any possible cross reaction with other infectious diseases such as chagas, tb, leprosy or malaria.


Eligibility criteria:
cases: inclusion criteria: * leishmania positive patient from italy (n=30) and from sudan (n=30); * patient with a clinically or laboratory confirmed diagnosis of leishmaniasis; * signed informed consent (criteria not applied in case of samples stored at the tropica biobank at the ditm) * being clinically classified as leishmaniasis patient by an experienced clinician or being laboratory confirmed as leishmaniasis patients, giving positive to at least two different serological tests or to a molecular test for leishmania sp. * adult subjects (equal or older than 18 years) exclusion criteria: * lack of the necessary data and/or of biological samples * subjects younger than 18 years community controls: inclusion criteria: * cryo-preserved serum samples stored at the tropica biobank at the ditm , irccs sacro cuore don calabria hospital, negrar (vr), from subject from italy (n=30) and from africa (n=30) with no infection due by leishmania spp. * signed informed consent to tropica biobank * adult subjects (equal or older than 18 years) * being negative to two different serological tests for leishmaniasis exclusion criteria: * subjects younger than 18 years * being positive to one serological tests for leishmaniasis. validation controls (vc): inclusion criteria: * serum samples stored in tropica biobank at the ditm from subjects that have been clinically diagnosed with chagas's disease, or tb, or malaria or leprosy. * informed consent signed to tropical biobank * adult subjects (equal or older than 18 years) * being negative to two different serological tests for leishmaniasis. * being clinically diagnosed with chagas disease or tb, or malaria or leprosy exclusion criteria: * younger than 18 years * positive result to one serological test for leishmaniasis.
cough among hypertensive patients treated with telmisartan, who had to stop previous ace-i treatment due to cough in poland

Conditions: Hypertension

Summary: in the light of ontarget and transcend studies results, it would be interesting to investigate the real-life telmisartan treatment tolerability. it is well known and accepted that the real-life setting is much more adequate to reflect the antihypertensive and safety properties of the drug in comparison to the organized and scheduled setting of the clinical trial. because there are not much data on the cough in relation to telmisartan, therefore it would we worth to observe the cough frequency and general treatment tolerance in patients treated with telmisartan, who had to stop their previous ace-i treatment due to cough.


Eligibility criteria:
inclusion criteria: - hypertension * age \> 18 * ace-i related cough exclusion criteria: - current treatment with telmisartan * cholestatic disorders and severe hepatic failure * allergy to telmisartan * pregnancy and lactation period

Keywords: cough telmisartan bradykinin tolerability
probe based confocal laser endomicroscopy during thoracoscopy for pleural malignancies diagnosis.

Conditions: Pleural Carcinomatosis

Summary: probe based confocal laser endomicroscopy (pcle) is a new optical endoscopic technique, generating fluorescent light emission from the tissue of interest and allowing in vivo live imaging at a cellular level ("optical biopsies"). it was first used in gastroenterology and came later to the light in pulmonary medicine and is still an experimental technique. in gastroenterology, this new investigational technique is used in barret oesophagus, inflammatory bowel disease, pancreas cystic lesions... nowadays, there are no data concerning usefulness of endomicroscopy in medical thoracoscopy. during thoracoscopy this new tool could help to target biopsies or help clinicians to do the right diagnosis early, allowing rapid therapeutic intervention (talc pleurodesis for example) . furthermore, some details can be studied only during live imaging as microorganisms or bloodflows. the investigators performed an endomicroscopy to every patient needing a thoracoscopy (no matter the indication) and who agreed to participate. the pcle features between malignant and benign pleura were compared in order to find specific criteria for malignant infiltration.


Eligibility criteria:
inclusion criteria: * every patient refered for a medical thoracoscopy and willing to participate. exclusion criteria: * \< 18 ans

Keywords: pcle confocal laser endomicroscopy pleural carcinomatosis mesothelioma optical biopsies
acupuncture on gb26 to treat chronic low back pain

Conditions: Chronic Low-back Pain

Summary: this study evaluates the effecacy of acupoint gb26 based acupuncture treatment in patients with chronic low back pain. half of the participants will partake in a 2-week acupuncture intervention, while the other half will receive a placebo treatment. the investigators hypothesize that acupuncture on gb26 reduces disability and pain more than the control intervention.


Eligibility criteria:
inclusion criteria: * adults (both male and female) with non-specific low back pain for more than three months. * age range: between 20 and 60 years. * willingness of the patient to participate in the study, and written informed consent signed and personally dated by the patient. * chronic non-specific low back pain clinically diagnosed as repeated lumbar sourness and swelling pain or a chronic progressive process, accompanied by (i) x-ray examination to exclude lumbar vertebrate fractures, spondylolysis, spondylolisthesis and severe osteoporosis, and/or (ii) mri with normal signal or low nucleus pulposus signal. exclusion criteria: * age less than 20 or greater than 60 years * specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections) * complicated back problems (e.g., prior back surgery, medico-legal issues) * possible contraindications for acupuncture (e.g., coagulation disorders, cardiac pacemakers, pregnancy, seizure disorder), and conditions that might confound treatment effects or interpretation of results (e.g., severe fibromyalgia, rheumatoid arthritis) * conditions making treatment difficult (e.g., paralysis, psychoses, or other severe psychiatric problems based on the judgment of a physician investigator and/or a t score \>60 on the psychological assessments performed during session 1) * prior acupuncture treatment for back pain; 1 year minimum for any other condition. * the intent to undergo surgery during the time of involvement in the study. * history of cardiac, respiratory, or nervous system disease that, in the judgment of a physician investigator, precludes participation in the study because of a heightened potential for adverse outcome (e.g., asthma, claustrophobia) * presence of any contraindications to mri scanning (e.g., cardiac pacemaker, metal implants, fear of closed spaces, pregnancy) * active substance abuse disorders within the last 24 months, based on subject self-report * radicular knee pain extending below the knee
evaluation of serum levels and pharmacokinetics of a new hepatitis b immune globulin following liver transplantation

Conditions: Hepatitis B, Chronic

Summary: the purpose of this study is to determine whether protective anti-hb serum levels are maintained after 6 months of uninterrupted treatment with igiv-hb grifols, a new specific hepatitis b immune globulin, in patients having previously undergone liver transplantation.


Eligibility criteria:
inclusion criteria: 1. patients having undergone a liver transplantation due to liver disease associated with hepatitis b virus, at least 1 year before and no more than 5 years before inclusion in the study. 2. patients who have required treatment with hbig, or are receiving it at present. 3. patients from 18 to 70 years of age. 4. the patient agrees to participate and comply with all aspects of the protocol, including the planned blood sample collection, and has signed the informed consent form. exclusion criteria: 1. presence of hbv dna or hbeag indicating virus replication. 2. patients with known allergies to some component of hb-ivig, such as sorbitol (e.g. patients presenting intolerance to fructose). 3. patients with a known background of severe or frequent reactions to products derived from plasma. 4. patients presenting arterial hypertension that is not clinically controlled. 5. patients presenting a creatinine value \>2 mg/dl, nephrotic syndrome or renal failure. 6. patients presenting anaemia (haemoglobin \< 11 g/dl). 7. patients being treated with interferon. 8. the patient suffers some acute or chronic medical condition that the investigator believes may interfere with the development or interpretation of the study. 9. the patient is known to abuse of alcohol, opiates, psychotropic agents or other drugs or chemical substances; or has done so in the past 12 months. 10. pregnant women at the time of inclusion or that may be pregnant in the next 7 months or breast-feeding women. 11. patients participating in another clinical study, or who have received another investigational product in the last 3 months. 12. possibility that the patient may be treated with other products containing immunoglobulins in a period of 7 months. 13. suspicion of conditions that may affect the patient's compliance, including an expected survival of less than 1 year. 14. any patient that does not have a frozen serum sample previous to the first study medication infusion. 15. patients with selective iga deficiency.

Keywords: hepatitis b hbv anti-hepatitis b antibodies immunoglobulins liver transplantation protective levels recurrence intravenous
discogel ®: evaluation of the procedure discogel ® in lumbar radiculopathy on slipped disc

Conditions: Hernia

Summary: lumbar disc herniation is the most important and frequent affection in rheumatology. the first treatment is based on an non-steroidal anti-inflammatory drugs.physiotherapy also is used.but when there is no efficient result, it's usual to propose to the patient corticoid injection, percutaneous intervention or arthrodesis. recently discogel® is a medical device used for lumbar disc herniation. however there is no studies evaluating the benefit and the efficiency of this technic. since a few years, the rheumatology service of ghpsj practise this technic using discogel® with patient resistant to the medical treatment . so the aim is to evaluate the benefit of discogel® retrospectively.


Eligibility criteria:
inclusion criteria: * age\> 18 * lumbar radiculalgy * lumbar disc herniation described by mri * more than 6 weeks * prescription of discogel exclusion criteria: * medical history of surgery at the same stage * patient under clopidogrel or prasugrel
early diagnosis for ocular ischemia syndrome using arterial spin labeling magnetic resonance imaging technique

Conditions: Ocular Ischemia Syndrome

Summary: 1. to evaluate ocular blood perfusion status and the possibility of craniocerebral vascular lesions of patients with ocular ischemia syndrome (ois) using arterial spin labeling (asl) magnetic resonance imaging technique. 2. to evaluate the specificity, sensitivity and accuracy of arterial spin labeling (asl) magnetic resonance imaging technique in ois diagnosis, compared with the traditional routine examination method.


Eligibility criteria:
inclusion criteria: * ocular ischemia syndrome group: patients diagnosed with ocular ischemia syndrome; * age-related macular degeneration group (control group): patients diagnosed with age-related macular degeneration; * age: 50-80 years; * sex: all; * patients signed written informed consent. exclusion criteria: * fundus fluorescein angiography (ffa) clear images cannot be obtained due to refractive media problems(such as corneal leukoplakia, severe cataract, vitreous hemorrhage, etc.) ; * patients with contraindications for ffa; * patients was unable to perform magnetic resonance rmaging (mri) test; * patients with history of bleeding and cerebral infarction; * patients with a history of surgery within 3 months; * patients who had participated in other clinical trials within 3 months; * patients who disagree and refuse to participate in the trial.
efficacy and biomarker explanation of ibi-323 + bevacizumab plus platinum based chemotherapy on alk-rearranged nsclc

Conditions: Non Small Cell Lung Cancer

Summary: this study aimed to explore the efficacy and biomarker explanation of ibi-323 combined with bevacizumab plus platinum based chemotherapy on alk-rearranged non-small cell lung cancer who failed from first line alectinib.


Eligibility criteria:
inclusion criteria: * sign written informed consent before implementing any trial-related procedures; * age ≥18 years old and ≤75 years old. * no limit on the gender. * patients diagnosed with lung adenocarcinoma alk-rearranged stage iiia-iv by pathology. * patients who failed from first line alectinib with stable brain metastasis included (radiotherapy treated oligo-metastasis). * according to the solid tumor efficacy evaluation criteria (recist v1.1), at least one lesion can be measured on imaging. lesions located in the field of previous radiation therapy may be considered measurable if progression is demonstrated. * ecog score 0-1 points. exclusion criteria: * patients with contraindication of chemotherapy pregnant or breast feeding women. * participate in another interventional clinical study, unless participating in an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study. * participants are known to have had previous severe allergic reactions to other monoclonal antibodies or to any of the components of the ibi323 preparation, and severe allergies to bevacizumab, pemetrexed, cisplatin, and carboplatin. * previous systematic anti-tumor therapy for advanced non-squamous nsclc other than alk-tki (including cytotoxic chemotherapy in combination with radiotherapy). * previous use of anti-pd-1 anti-pd-l1 anti-programmed death receptor ligand 2(pd-l2) or anti-cytotoxic t-lymphocyte-associated antigen 4(ctla-4) drugs or any other drugs that act on t-cell co-stimulation or checkpoint pathways (such as ox40 cd137 lag3, etc.). * radical radiation therapy within 28 days prior to the first dose, or palliative radiation therapy within 14 days prior to the first dose. * received alk-tki treatment within 2 weeks prior to the first administration of the study drug
local anesthetic infiltration and infusion for pain control after hip replacement

Conditions: Osteoarthritis

Summary: the purpose of this study is to examine three different ways to control pain after hip replacement: 1. one time injection of ropivacaine before wound closure 2. one time injection of ropivacaine before wound closure plus slow release of ropivacaine via catheter for 48 hours 3. standard practice of patient controlled pump


Eligibility criteria:
inclusion criteria: * total knee replacement exclusion criteria: * history of neurological disease, diabetes, pregnancy, allergy to local anesthetic solutions chronic narcotic use ability to consent
comparative study of human immunodeficiency virus negative host talaromyces between voriconazole and amphotericin sequential itraconazole therapy

Conditions: Talaromyces in Human Immunodeficiency Virus Negative; To Compare Voriconazole and Amphotericin Sequential Itraconazole Therapy; To Dynamically Monitor the Anti-Interferon-γ Autoantibodies

Summary: through a multi-center large-sample non-randomized controlled study, the effect of voriconazole, amphotericin b sequential itraconazole therapy on talaromyces in human immunodeficiency virus（hiv）negative hosts were compared to clarify whether the two therapies were equivalent; a comprehensive efficacy evaluation system and standard treatment program was established to provide a basis for standardized treatment of talaromyces in human immunodeficiency virus negative hosts.the observational indicators included: 2-week all-cause mortality; 24-week all-cause mortality; clinical improvement time; level of decrease of fungus in the blood culture medium two weeks before treatment; recurrence; appearance of adverse drug reaction at the level 3 and above. dynamically monitor the immune cells and factors like anti-interferon-γ autoantibodies, interferon-γ, th1/th2, and th17/treg in the hiv-negative talaromyces host microenvironment, and observe the host's immune status and its change. 3. study the effect of absence of interferon-γ and interferon-γ receptor (ifn-γr）on the activation and function of anti-interferon-γ autoantibodies, th1/th2, and th17/treg by establishing a talaromyces mouse model that knocks out the interferon-γ and ifn-γr gene and a ifn-γ silenced cell model; study the effect of anti-ifn-γ autoantibody on the activation and function of ifn-γ、th1/th2、th17/treg by increasing its titer in vitro and vivo; determine by which path the anti-ifn-γ autoantibody of hiv-negative host influences its immune regulation mechanism; finally, the intervention effect of ifn-γ on high titer anti-ifn-γ autoantibodies is studied, providing a new idea for immunotargeted therapy.


Eligibility criteria:
inclusion criteria: 1. hiv-negative adults (≥18 years of age) who diagnosis of talaromyces that was confirmed by either microscopy or culture 2. must be able to swallow tablets exclusion criteria: 1. pregnancy, central nervous system involvement assessed either clinically or by analyses of cerebrospinal fluid 2. an allergy to voriconazole, itraconazole or amphotericin 3. the concomitant use of certain medications that interact with voriconazole, itraconazole or amphotericin 4. an alanine aminotransferase or aspartate aminotransferase level of more than 400 u per liter 5. an absolute neutrophil count of less than 500 per cubic millimeter 6. a creatinine clearance of less than 30 ml per minute (calculated by the method of cockcroft and gault) 7. a concurrent diagnosis of cryptococcal meningitis 8. concurrent treatment with rifampicin 9. previous treatment for talaromyces for more than 48 hours 10. hiv positive who diagnosis of talaromyces.

Keywords: talaromyces voriconazole amphotericin sequential itraconazole therapy anti-interferon-γ autoantibodies
comparison of skin prick testing, extract-specific ige antibody testing and component resolved diagnosis in diagnosing of legume allergy

Conditions: Food Allergy Suspected

Summary: the study is aimed at improving the diagnosis of food allergy, specifically allergy to commonly consumed legumes such as peas, lentils, chickpeas or green beans. patients suspected of allergy to these legumes will be examined using traditional methods of ige-mediated allergy diagnosing (skin prick test, testing for specific ige antibodies against food extract), but also by testing for specific ige antibodies against relevant allergenic molecules of these legumes. the results of performed tests will be compared with the result of the oral food challenge, which is considered to be the gold standard of food allergy diagnosis.

legumes are one of the major food allergens, but these are usually peanuts or soybeans. other legumes, such as peas, lentils, chickpeas or green beans, have been overlooked, but some studies suggest that they may also cause allergic reactions ranging from urticaria to anaphylaxis. the prevalence of allergy to these neglected legumes can range widely (0.5-39.6%) depending on the patient group and the method of allergy diagnosis. the main allergens of legumes are the seed storage proteins, including 7s and 11s globulins and especially 2s albumins, which can cause the most severe, often systemic allergic reactions. these proteins are characterized by their considerable resistance to heat and other physical or chemical influences. other important legume allergens in our geographical area are the pr-10 proteins cross-reacting with the major allergen of birch pollen (bet v 1), which in turn are more sensitive to heat treatment and tend to be the source of milder, more local reactions. in contrast, sensitization to other allergen groups, such as lipid transfer proteins (ltps), oleosins or profilins, is less significant.

Eligibility criteria:
inclusion criteria: * age: ≤ 65 years * signing informed consent to the study * a positive history of an immediate allergic reaction to one or more of the legumes studied (peas, lentils, chickpeas, beans) with skin, gastrointestinal, respiratory or cardiovascular symptoms occurring within 2 hours after ingestion and a positive result of specific ige testing against alex and/or skin prick test with the legume * patients with a positive ofc with any of the legumes studied exclusion criteria: * disagreement with the implementation of the oral food challenge * history of severe systemic allergic reaction to the legume in question (ring-messmer grade ≥ 3)

Keywords: food allergy component resolved diagnosis skin prick test oral food challenge legume allergy
a study of lcar-aio car-t cells for treating relapsed/refractory neurological autoimmune diseases

Conditions: Multiple Sclerosis (MS); Neuromyelitis Optica Spectrum Disease (NMOSD); Anti-Myelin Oligodendrocyte Glycoprotein-IgG Associated Disorders (MOGAD); Myasthenia Gravis

Summary: this is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of lcar-aio in adult subjects with relapsed/refractory neurological autoimmune diseases.

this is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of lcar-aio, a chimeric antigen receptor (car) -t cell therapy in subjects with relapsed/refractory neurological autoimmune diseases. patients who meet the eligibility criteria will receive lcar-aio infusion. the study will include the following sequential stages: screening, apheresis, pre-treatment (cell product preparation: lymphodepleting chemotherapy), treatment (lcar aio infusion) and follow-up.

Eligibility criteria:
inclusion criteria: 1. subjects voluntarily participate in clinical research. 2. age 18-70 years. 3. adequate organ function at screening. 4. clinical laboratory values meet criteria at screening visit. 5. indications include: ms; 1. have been diagnosed of ms at least 6 months before screening. 2. fulfill relapsed/refractory ms conditions. nmosd/mogad: 1. have been diagnosed of nmosd/mogad at least 6 months before screening. 2. aqp-4 igg (nmosd), or mog-igg (mogad) should be positive by cba (cell based transfection immunofluorescence assay). 3. fulfill relapsed/refractory nmosd/mogad conditions. mg: 1. have been diagnosed of mg at least 6 months before screening. 2. achr-igg or musk-igg should be positive. 3. fulfill relapsed/refractory nmosd/mogad conditions. exclusion criteria: 1. active infections such as hepatitis and tuberculosis. 2. other autoimmune diseases. 3. serious underlying diseases such as tumor, uncontrolled diabetes and clinically significant cardiovascular disease. 4. female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving lcar-aio treatment.

Keywords: relapsed/refractory multiple sclerosis (r/r ms) relapsed/refractory neuromyelitis optica spectrum disease (r/r nmosd) relapsed/refractory anti-myelin oligodendrocyte glycoprotein-igg associated disorders (r/r mogad) relapsed/refractory myasthenia gravis (r/r mg)