Kornimate/medical-research-clean huggingface dataset:
rituximab combined with cyclosporine versus rituximab alone in the treatment of imn

Conditions: Idiopathic Membranous Nephropathy

Summary: the primary objective of this study is to determine whether or not cyclosporine (csa) combined with rtx is more effective than rtx alone in the treatment of idiopathic membranous nephropathy (imn).

to date, the first-line immunosuppressive therapy of imn includes corticosteroids combined with cyclophosphamide or rituximab (rtx) which has been used more and more widely due to superior safety profiles. but the long term remission rate of rtx monotherapy is only 60% and it takes effect relatively slowly. 2 pilot studies reported that the combination therapy of cyclosporine (csa) and rtx had better efficacy for inducing remission for imn, with the long term remission rate up to 85%. csa and rtx may have synergistic effect in the treatment of imn because they have different time of action and different effects on the immune system and podocytes. based on the previous rationale, the investigators designed this trial to determine whether combination of csa and rtx is more effective than rtx alone in the treatment of imn.

Eligibility criteria:
inclusion criteria: * idiopathic mn with or without diagnostic biopsy * female, must be post-menopausal, sterile or have effective method of contraception * must be off steroid or mycophenolate mofetil for \>1 month and alkylating agents for \> 6 months * angiotensin-converting-enzyme inhibitor (acei) or angiotensin receptor blocker (arb) for ≥3 months prior to randomization with controlled blood pressure or if patients is intolerant to acei/arb * proteinuria ≥4g/24h using the average from two 24-hour urine samples collected within 2 weeks of each other, and decreased ≤50% from baseline. * estimated glomerular filtration rate (egfr) ≥40ml/min/1.73m2 exclusion criteria: * presence of active infection or a secondary cause of mn * diabetes mellitus: to exclude proteinuria secondary to diabetic nephropathy. * pregnancy or breast feeding * history of resistance to csa or other calcineurin inhibitors(cni), rtx or alkylating agents. * patients who previously achieved remission after treatment of cni, rtx or alkylating agents but relapsed off cni after 3 months, or relapsed off rtx or alkylating agents after 6 months, are eligible.

Keywords: rituximab cyclosporine idiopathic membranous nephropathy
biomarkers and inflammation in solid organ transplantation: relationship with short- and long-term outcomes

Conditions: Solid Organ Transplantation

Summary: this is a prospective, tissue-based, low-risk, non-pharmacological study that will include adult patients undergoing solid organ transplantation (heart, liver, lung, kidney) followed at the following units of the irccs azienda ospedaliero-universitaria di bologna (irccs aoubo): * heart failure and transplants (heart-lung) * internal medicine for the treatment of severe organ failures (liver) * nephrology, dialysis, and transplantation (kidney).

the aim of this study is to perform objective biological measurements of inflammation and cellular senescence (i.e., plasma profiles of cytokines, inflammatory mirnas, circulating free dna, extracellular vesicles), immunosenescence (i.e., circulating and tissue-based leukocyte profiles of aging), and systemic and tissue aging (i.e., epigenetic clocks) in the collected cohort. these measures may help to stratify patients at higher risk of transplant failure (graft damage) or those at higher risk of cardiovascular, renal, metabolic, neoplastic complications, or increased mortality. additionally, the study aims to implement therapeutic or prophylactic measures based on biological stratification to prevent the progression of biological damage. it is also important to highlight that the identification of markers of cellular senescence, immunosenescence, and epigenetic aging in the recipient could define patterns that guide more appropriate and personalized immunosuppressive treatments.

Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years old at the time of enrollment) who have undergone at least one of the following: liver transplant, kidney transplant, heart transplant, lung transplant during the study period. * informed consent acquisition. exclusion criteria: * none
elimination of adjuvant chemotherapy for selected stage ii and iii nasopharyngeal carcinoma

Conditions: Nasopharyngeal Cancer

Summary: this study evaluates whether some patients with nasopharyngeal carcinoma but with low risk of distant metastasis can be treated with only radiotherapy and concomitant chemotherapy but without additional adjuvant chemotherapy.

the standard treatment for stage ii-iii nasopharyngeal carcinoma is radiotherapy with concomitant chemotherapy and adjuvant chemotherapy. a subset of these patients has very low risk for distant metastasis that adjuvant chemotherapy is probably unnecessary. the investigators would like to know if same therapeutic effect and survival rate can be achieved without adjuvant chemotherapy, (i.e. less chemotherapy, same effect)

Eligibility criteria:
inclusion criteria: * (1) biopsy-proven carcinoma of the nasopharynx, * (2) ajcc 1997 stage ii (t2an0, t1-t2an1) or iii (t1-t2an2) disease, * (3) normal renal function (cr \< 1.6 mg/dl), exclusion criteria: * open-neck lymph node biopsy * previous chemotherapy or radiotherapy to the head and neck region * distant metastasis or other malignant diseases except skin cancer

Keywords: adjuvant chemotherapy npc
observational study of type 1 diabetics switching from human insulins to modern insulin analogues

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this observational study is to evaluate the blood glucose control (hba1c) using novorapid® (insulin aspart) and levemir® (insulin detemir) after switch from human insulins for treatment of type 1 diabetes under normal clinical practice conditions in romania.


Eligibility criteria:
inclusion criteria: * any subject with type 1 diabetes who is treated with human rapid and intermediate (nph) insulin in basal-bolus regimen exclusion criteria: * subjects currently being treated with insulin aspart and insulin detemir * subjects who were previously enrolled in this study * subjects with a hypersensitivity to insulin aspart or to any of the excipients * subjects with a hypersensitivity to insulin detemir or to any of the excipients * women who are pregnant or have the intention of becoming pregnant within next 6 months
prevalence of ocular disorders in multiple myeloma (mm-oo-16)

Conditions: Multiple Myeloma

Summary: overall survival of multiple myeloma (mm) patients has increased significantly due to the availability of the new drugs. moreover, since mm is an incurable disease, patients are exposed to repeated lines of therapy with different agents. it is therefore increasingly important to monitor the long-term side-effects of treatments. in the present study we focused on ocular disorders. this is an observational study aiming to assess the prevalence of ocular disorders in 100 patients on treatment or follow-up for mm.

this is an observational study aiming to assess the prevalence of ocular disorders in patients on treatment or follow-up for mm. study population patients diagnosed with multiple myeloma on treatment and/or on follow-up after treatment for multiple myeloma. the study aims to enroll 100 patients. endpoints primary endpoint: to determinate prevalence and main characteristics of ocular disorders in patients on treatment / or previously treated for multiple myeloma. secondary endpoints: 1. to evaluate the relation between the kind of treatment for multiple myeloma and the development of ocular disorders 2. to evaluate the relation between patient's characteristics and comorbidities (such as sex, age, smoking, hypertension, diabetes, autoimmune diseases) and the presence of ocular disorders in this population of patients. study design patients will be enrolled in the study at any time starting for the 3rd month of treatment, regardless if they are still on treatment or not. patients will undergo an ocular evaluation including visual acuity analysis, evaluation of the anterior ocular segment, fundus oculi analysis, ocular pressure measurement, schirmer's test. if clinically required by the ophthalmologist, the patient will also undergo: * optical computerized tomography * fundus autofluorescence * fluorescein angiography * computerized visual field

Eligibility criteria:
inclusion criteria: * age \> 18 years * diagnosis of multiple myeloma * patients have started an active treatment for multiple myeloma since at least two months * patients on active treatment for relapsed/refractory multiple myeloma * patients on follow-up after previous active treatment for multiple myeloma exclusion criteria: * bilateral blindness preceding the diagnosis of multiple myeloma * no signature of the informed consent * patients have started an active treatment for multiple myeloma since less than two months
study on lymphocyte subsets of peripheral blood in patients with nonmyopathic dermatomyositis complicated with pulmonary interstitial disease

Conditions: Dermatomyositis

Summary: to detect the changes of lymphocyte subsets in peripheral blood of non-myopathic dermatomyositis with pulmonary interstitial disease, classical dermatomyositis with pulmonary interstitial disease, rheumatism with non-inflammatory myopathy with pulmonary interstitial disease and healthy adults among the 4 groups, and to detect the related cytokines secreted by lymphocyte subsets th1,th2 and th17. clinical features, distribution of peripheral lymphocyte subsets ratio and related cytokine content secreted by each lymphocyte subset were analyzed in each group, so as to explore the pathogenesis characteristics of nonmyopathic dermatomyositis complicated with pulmonary interstitial disease, in order to facilitate clinical guidance for diagnosis and treatment.


Eligibility criteria:
inclusion criteria: 1. the experimental group met the diagnostic criteria of sontheimer and was diagnosed as cadm with pulmonary interstitial disease. 2. control group 1: the diagnosis was consistent with the diagnostic criteria of bohan and perter classification system, and it was confirmed that dermatomyositis was combined with pulmonary interstitial disease; 3. control group 2: the diagnosis meets the classification criteria of systemic lupus erythematosus revised by the american college of rheumatology (acr) in 1997 and is confirmed as systemic lupus erythematosus combined with pulmonary interstitial disease, or the diagnosis meets the diagnostic criteria of rheumatoid arthritis introduced by acr in 1987 or acr in 2010 and is confirmed as rheumatoid arthritis combined with pulmonary interstitial disease. 4. age 18-70 years old; 5. have a good understanding of their own illness and physical condition, have self-knowledge, can communicate well with others; 6. voluntarily join the study, understand the significance of the experiment and the indicators to be measured, and sign the informed consent. exclusion criteria: 1. severe infection: fever, cough, phlegm, sore throat, abdominal pain, diarrhea, carbuncle and other skin and soft tissue infection and other clinical manifestations, blood routine white blood cell count beyond the normal range (10×109/l); 2. severe cardiovascular disease: including chronic heart dysfunction grade 3 or above and various arrhythmias; 3. infectious diseases: hepatitis active stage, aids, syphilis, etc. 4. tumor markers of patients suggest the possibility of tumor. 5. patients with neuromuscular disease, inflammatory bowel disease, functional gastrointestinal disease; 6. the patient has other connective tissue diseases or disorders.
a safety study of xolair (omalizumab) in patients with chronic idiopathic urticaria (ciu) who remain symptomatic despite treatment with h1 antihistamines, h2 blockers, and/or leukotriene receptor antagonists

Conditions: Chronic Idiopathic Urticaria

Summary: the study is a global phase iii, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the safety and efficacy of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with chronic idiopathic urticaria (ciu) who remain symptomatic despite standard-dosed h1 antihistamine treatment (including doses up to 4 times above the approved dose level), h2 blockers, and/or leukotriene receptor antagonists (ltra).


Eligibility criteria:
inclusion criteria: * diagnosis of chronic idiopathic urticaria (ciu) refractory to h1 antihistamines, h2 blockers, and/or leukotriene receptor antagonists (ltra) at the time of randomization. * the presence of itch and hives for \> 6 consecutive weeks at any time prior to enrollment despite current use of h1 antihistamine (up to 4 times the approved dosage), h2 blocker, and/or ltra treatment during this time. * urticaria activity score over 7 days (uas7) score (range 0-42) ≥ 16 and itch component of uas7 (range 0-21) ≥ 8 during 7 days prior to randomization (week 0). * in-clinic uas ≥ 4 on at least one of the screening visit days (day -14, day -7, or day 1). * for women of childbearing potential, agreement to use an acceptable form of contraception and to continue its use for the duration of the study. exclusion criteria: * treatment with an investigational agent within 30 days prior to screening. * weight less than 20 kg (44 lbs). * clearly defined underlying etiology for chronic urticarias other than ciu. * evidence of parasitic infection. * atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or other skin disease associated with itch. * previous treatment with omalizumab within a year prior to screening. * routine doses of the following medications within 30 days prior to screening: systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide. * intravenous (iv) immunoglobulin g (ivig), or plasmapheresis within 30 days prior to screening. * regular (daily/every other day) doxepin (oral) use within 6 weeks prior to screening. * patients with current malignancy, history of malignancy, or currently under work-up for suspected malignancy except non-melanoma skin cancer that has been treated or excised and is considered resolved. * hypersensitivity to omalizumab or any component of the formulation. * history of anaphylactic shock. * presence of clinically significant cardiovascular, neurological, psychiatric, metabolic, or other pathological conditions that could interfere with the interpretation of the study results and or compromise the safety of the patients. * evidence of current drug or alcohol abuse.
mixed antagonist of serotonin for claudication optimal therapy

Conditions: Intermittent Claudication

Summary: to investigate in patients suffering from intermittent claudication due to fontaine stage ii pad whether a 24-week treatment by sl650472 od on top of clopidogrel may result in an improvement of walking capacity, by comparing three doses of sl650472 to placebo, and to calibrate such effect versus cilostazol


Eligibility criteria:
inclusion criteria: * 1. patient with stable symptoms of intermittent claudication of the lower extremities, secondary to chronic occlusive arterial disease from atherosclerosis origin (symptoms present for 6 months or longer and not significantly changed within the past 3 months); * 2. icd of 30 to 200 m at screening constant workload treadmill test * 3. doppler-measured pre-treadmill abi of 0.90 or lower after 10 minutes of rest or, for patients with an abi of greater than 1.3 (non-compressible arteries), a toe-brachial index (tbi) of less than 0.7. exclusion criteria: * 1. age below 40 years and/or onset of symptoms of pad before the age of 40 years; * 2. non-atherosclerotic vascular disease (e.g. buerger's disease, popliteal entrapment syndrome); * 3. limb-threatening (grades iii and iv) chronic limb ischemia, manifested by ischemic rest pain, ulceration, or gangrene. * 4. patients with a history of malignant or proliferate breast disease.
impact on the quality of life and persistent symptoms of patients away from diagnosed and treated neuroborreliosis

Conditions: Neuroborreliosis, Lyme; Quality of Life

Summary: the link between lyme neuroborreliosis (nbl) and persistent symptoms is debated in the medical world. some report a frequency of post nbl symptoms similar to the general population, and others define a specific entity, the ptlds (post treatment lyme disease symptoms). in france, few studies have evaluated the persistent symptoms and the impact on the quality of life of patients after treatment for nbl.


Eligibility criteria:
inclusion criteria: * have been hospitalized or consulted for neuroborreliosis between 2010 and 2021; * have a diagnosis of probable neuroborreliosis (compatible clinical signs + lumbar puncture with positive intrathecal synthesis of immunoglobulins) or certain (compatible clinical signs + lumbar puncture with pleocytosis and positive intrathecal synthesis of immunoglobulins); * have received adequate treatment according to the recommendations (1st intention doxycycline 100mgx2/day or 2nd intention ceftriaxone iv 2g/day for 14 to 21 exclusion criteria: * be part of the entourage of the cases; * do not have atcd of lyme borreliosis (especially erythema migrans); * not having been bitten by a tick in the last 5 years;
the effects of statin on postoperative renal function in valvular heart surgery: a randomized, placebo-controlled study

Conditions: Acute Kidney Injury

Summary: the aim of this study is to examine the association between preoperative statin treatment and the incidence of postoperative acute kidney injury(aki) in patients undergoing valvular heart surgery.


Eligibility criteria:
inclusion criteria: - patients over the age of 20 scheduled for valvular heart surgery exclusion criteria: 1. current statin use 2. left ventricular ejection fraction \< 30% 3. preexisting congestive heart failure 4. severe coronary artery disease 5. hemodynamically unstable arrhythmia 6. cardiogenic shock during perioperative period 7. ventricular assist device 8. severe renal dysfunction (egfr \< 15 ml/min per 1.73 m2) 9. history of liver disease or elevated serum transaminases 10. history of rhabdomyolysis or elevated creatinine kinase

Keywords: aki, atrovastatin, valvular heart surgery
evaluating different doses of orelabrutinib in mcl

Conditions: Mantle Cell Lymphoma

Summary: this is a randomized,open-label, multicenter, phase ii trial evaluating two different doses of orelabrutinib in mantle cell lymphoma to evaluate the efficacy and safety in mantle cell lymphoma.


Eligibility criteria:
inclusion criteria: 1. male and female subjects ≥ 18 years of age. 2. mantle cell lymphoma (mcl) confirmed by histopathology. 3. subjects who have not previously received standard systemic care and relapsing/refractory subjects who have previously received standard systemic care. 4. at least one measurable lesion. 5. ecog physical fitness score 0-2 points. 6. expected survival time ≥ 4 months. 7. full hematology function. 8. blood clotting function is basically normal. 9. subjects with basically normal liver, kidney and heart function. 10. subject voluntarily signs a written icf. 11. the serum pregnancy test of female subjects with fertility potential was negative within 7 days before the first dosing. 12. female subjects with reproductive potential or male subjects and their partners must agree to use effective contraception for at least 6 months from signing the icf until the last dose of the study drug. exclusion criteria: 1. adequate treatment with btk inhibitors. 2. have a history of severe allergic disease and a history of severe drug allergy. 3. subjects who have received the treatment or drug restricted in the protocol within the time specified for the first use of the investigational drug. 4. the last use of a potent cyp3a inhibitor or potent cyp3a inducer (including food, western medicine, and chinese medicine) was less than 2 weeks (or less than 5 half-lives, depending on the time) from the first trial, or plan to take a potent cyp3a inhibitor or potent cyp3a inducer drug or food during the study period. 5. history of other active malignant diseases within 2 years prior to screening. 6. subjects with systemic bacterial, viral, fungal (other than nail fungal infections) or parasitic infections with poorly controlled activity. 7. indicates active hepatitis b or c virus infection. 8. there are diseases that are excluded from the criteria in the programme. 9. toxicity of previous anticancer therapy was still ≥ grade 2 at the start of study therapy (according to ctcae v5.0). 10. history of severe bleeding disorder. 11. people with a known history of alcohol or drug abuse. 12. subjects with mental disorders or poor compliance. 13. pregnant or lactating female subjects. 14. other conditions deemed unsuitable for participation in this study by the investigator.
valproate as first line therapy in combination with rituximab and chop in diffuse large b-cell lymphoma

Conditions: Diffuse Large B-cell Lymphoma

Summary: patients with previously untreated diffuse large b-cell lymphoma will receive standard treatment with r-chop (rituximab,cyclosphosphamide, doxorubicin, vincristine, and prednison) for 6 cycles, cycle length is 14 or 21 days. in addition, valproate is given three times daily day 1-3 in escalated doses. the rationale for adding valproate to standard treatment is invitro data indicating a sensitizing effect to chemotherapy, and an increase in cd 20-expression. patients are included in 3+3 cohorts with escalation of valproate dose, planned dos levels are 30, 60, 80, 100, 120, 140 mg/kg/day. a total of 20 patients will be treated at the mtd.


Eligibility criteria:
inclusion criteria: * age 18-80 years * histologically confirmed (according to the who classification) diffuse large b-cell lymphoma stage ii-iv * no previous treatment for lymphoma. corticosteroids for alleviation of lymphoma associated symptoms are allowed * who performance status 0-2 * hiv negativity * seronegativity for hcv, hbsag, anti-hbc, or other active infection uncontrolled by treatment * absence of psychiatric illness or condition which could interfere with the subjects ability understand the requirements of the study * absence of neurological or neuropsychiatric disorder, interfering with the requirements of the study * absence of hearing impairment \> grade 2 * absence of porphyria * in females: absence of pregnancy and lactation * all subjects must agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy * all subjects must agree not to share study medication with another person, and to return all unused study drug to investigators * written informed concent according to ich/gcp and swedish regulations

Keywords: lymphoma diffuse large b-cell lymphoma valproate r-chop cd 20