Kornimate/medical-research-clean huggingface dataset:
antiplatelet drug resistances and ischemic events

Conditions: Symptomatic Atherothrombosis

Summary: the adrie study is an observational study on the clinical relevance of platelet reactivity in aspirin and clopidogrel treated cardiovascular patients.

the adrie study is an observational study on the clinical relevance of platelet reactivity in aspirin and clopidogrel treated cardiovascular patients. main objective: * to determine if platelet reactivity, assessed by specific and non-specific tests, is predictive of ischemic events during the 3-year follow-up. secondary objectives: * primary outcome in each pre-specified sub-group : patients with coronary artery disease, ischemic stroke or peripheral arterial disease as main qualifying disease at entry, * to determine if platelet reactivity, assessed by specific and non-specific tests, is predictive of bleeding events during the 3-year follow-up, * to investigate potential determinants of platelet reactivity at entry in the study

Eligibility criteria:
inclusion criteria: * documented symptomatic ischemic atherothrombotic disease treated by aspirin, clopidogrel or both. exclusion criteria: * known platelet disorder * chronic treatment by antiplatelet drugs other than aspirin or clopidogrel. * chronic anticoagulant treatment * chronic non steroid anti inflammatory drug treatment * active cancer * ongoing aspirin or clopidogrel treatment taken for more than 5 years prior to inclusion

Keywords: antiplatelet drug resistance atherothrombosis
a study of an oral short-course regimen including bedaquiline for the treatment of participants with multidrug-resistant tuberculosis in china

Conditions: Tuberculosis, Multidrug-Resistant

Summary: the purpose of this study is to evaluate efficacy and safety of an oral bedaquiline-containing multidrug-resistant tuberculosis (mdr-tb) short-course regimen (scr) compared to an oral scr not including bedaquiline at the end of treatment in participants with pulmonary mdr-tb in china.


Eligibility criteria:
inclusion criteria: * has a positive sputum mycobacterium tuberculosis culture from a test performed at screening * has microbiological confirmation of rifampicin resistance by genexpert and to isoniazid (inh) via molecular drug-susceptibility testing (dst) showing katg mutation * has a chest imaging result compatible with a diagnosis of pulmonary tuberculosis (tb) * agrees to use effective contraception during the 40-week study treatment phase. a female participant must be: of nonchildbearing potential; of childbearing potential and practicing effective methods of contraception during the 40-week study treatment phase * is willing to undergo human immunodeficiency virus (hiv) testing exclusion criteria: * has received prior treatment with bedaquiline * has prior exposure to at least 1 second-line drug in the regimen for at least 4 weeks * has any grade 3 or 4 laboratory abnormality as confirmed by a clinical expert * has a known allergy or intolerance to bedaquiline or other drugs in the regimen * is infected with a strain of nontuberculous mycobacteria * is hiv-positive
an observational study of mircera (methoxy polyethylene glycol-epoetin beta) in patients with renal anemia

Conditions: Anemia

Summary: this observational study will investigate hemoglobin levels and mircera (methoxy polyethyleneglycol-epoetin beta) dose over time in patients with chronic kidney disease, and compare standards of care between centers. data from each patient will be collected over 12 months of mircera therapy.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * chronic kidney disease * informed consent for data transmission exclusion criteria: * serious hematological or infectious disease * acute bleeding in the 16 weeks preceding data collection * participation in an interventional trial * female patients: pregnancy or breast-feeding
study of hpn217 in participants with relapsed/refractory multiple myeloma mk-4002 (mk-4002-001)

Conditions: Multiple Myeloma in Relapse; Multiple Myeloma; Multiple Myeloma of Bone; Multiple Myeloma With Failed Remission

Summary: researchers want to learn if mk-4002 (also known as hpn217) can treat relapsed or refractory multiple myeloma (rrmm). the goals of this study are to learn about the safety of different doses of mk-4002 and how well people tolerate them. researchers also want to learn what happens to different doses of mk-4002 in a person's body over time.


Eligibility criteria:
major inclusion criteria: 1. patients ≥18 years of age at the time of signing informed consent 2. documented rrmm for which no standard therapy options are anticipated to result in a durable remission. relapse defined as progressive disease after initial response (minimal response \[mr\] or better) to previous treatment, more than 60 days after cessation of last treatment. refractory disease defined as \<25% reduction in m protein or progression of disease during treatment or within 60 days after cessation of treatment. 3. received at least 3 prior therapies (including proteasome inhibitor, immune modulatory drug, and an anti-cd38 antibody; patients should not be a candidate for or be intolerant of all established therapies known to provide clinical benefit in multiple myeloma). 4. measurable disease defined as at least one of the following: 1. serum m-protein ≥0.5 g/dl 2. urine m-protein ≥200 mg/24 hours 3. serum free light chain (flc) assay: involved flc level ≥10 mg/dl (≥100 mg/l) and an abnormal serum flc ratio (\ 1.65) 5. resolved acute effects of any prior therapy to baseline severity or common terminology criteria for adverse events (ctcae) version 5.0 grade ≤1. major exclusion criteria: 1. plasma cell leukemia; non-secretory myeloma (e.g., solitary plasmacytoma) 2. patients with only extramedullary relapse of multiple myeloma who do not meet requirement for measurable disease. 3. prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within \<90 days of the start of study 4. prior allogeneic stem cell transplantation or solid organ transplantation within 12 months of screening. however, any patient receiving immunosuppressive medication will be excluded. 5. history of or known or suspected autoimmune disease (exception(s): patients with vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at screening are allowed). other exceptions may be allowed following discussion with the sponsor medical monitor for patients who have not received any treatment for their autoimmune disorder in the past 3 years 6. second primary malignancy that has not been in remission for greater than 3 years. exceptions that do not require a 3-year remission: non-melanoma skin cancer, resected melanoma in situ, in situ cervical cancer, adequately treated stage i cancer from which the subject is currently in remission and has been in remission for ≥2 years, low-risk prostate cancer with gleason score \<7 and prostate-specific antigen \<10 ng/ml
fatigue levels in fibromyalgia syndrome

Conditions: Fatigue; Fibromyalgia

Summary: ninety (90) woman patients diagnosed with fibromyalgia according to the american college of rheumatology 2010 diagnostic criteria and 90 healthy volunteers were included. the fibromyalgia impact questionnaire (fiq) is used to assess the patient's functionality and determine the severity of the disease. the fatigue severity scale (fss) assessed the level and severity of fatigue. the short form of the international physical activity questionnaire (ipaq-sf) used to asess physical activity levels.the kinesiophobia level was assessed by using the tampa scale for kinesiophobia.

our study consists of 180 female participants aged between 18 and 65 years who applied to the physical therapy and rehabilitation outpatient clinic between april 2021 and august 2021. this case-control study was conducted according to the declaration of helsinki. participants gave written voluntary consent and enrolled in this case-control study. ninety (90) woman patients diagnosed with fibromyalgia according to the american college of rheumatology 2010 diagnostic criteria and 90 healthy volunteers were included. fibromyalgia impact questionnaire, tampa kinesiophobia scale, fatigue severity scale and the short form of i̇nternational physical activity questionnaire (ipaq-sf) were completed. all scales were filled in face to face for the participants. in addition, demographic data (age, gender, height, weight, marital status, education level) and duration of fibromyalgia diagnosis were recorded. exclusion criteria for both groups; the presence of health problems that affect the level of physical activity ( cardiac or pulmonary insufficiency, limb amputation, recent surgery history) and cognitive impairment that prevents answer questions

Eligibility criteria:
inclusion criteria: * ninety (90) woman patients diagnosed with fibromyalgia according to the american college of rheumatology 2010 diagnostic criteria * ninety (90) healthy volunteers exclusion criteria: * the presence of health problems that affect the level of physical activity ( cardiac or pulmonary insufficiency, limb amputation, recent surgery history) * cognitive impairment that prevents answer questions

Keywords: fibromyalgia syndrome physical activity kinesiophobia
efficacy and safety study of pamoate of triptorelin in children with precocious puberty

Conditions: Precocious Puberty

Summary: the purpose of the study is to assess the efficacy of triptorelin 11.25 mg pamoate in the delay of premature onset of puberty in girls less than 9 years and boys less than 10 years. this is measured by assessing the proportion of children who have a suppressed luteinizing hormone (lh) response to gonadotropin releasing hormone (gnrh) test performed 3 months after injection with triptorelin 11.25 mg.


Eligibility criteria:
inclusion criteria in the screening phase: * onset of sex characteristics (tanner method) breast development in girls or testicular enlargement in boys before the age of 8 years in girls and 9 years in boys. * weight ≥ 20 kg. inclusion criteria in the treatment phase: * proven central precocious puberty defined as onset of sex characteristics development (according to tanner method) diagnosed before the age of 8 years in girls and 9 years in boys. * age at evaluation less than 9 years for girls and 10 years for boys. * a pubertal response of lh to gnrh test in both sexes (stimulated lh ≥ 5 iu/l). * difference bone age (ba) (according to greulich et pyle method) - chronological age (ca) \> 1 year. * testosterone level ≥ 0.5 ng/ml in boys. exclusion criteria: * patient with a peripheral precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion. * patient with a cerebral tumour requiring a neurosurgery or cerebral irradiation. * patient with a body weight ≥ 125% of the ideal weight for the height and age (growth curves). * the patient has received a previous treatment with a gnrh analogue, or medroxyprogesterone or cyproterone acetate.
pharmacokinetic drug interaction study with dapagliflozin and glimepiride in healthy subjects

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers. in addition, the safety and tolerability of dapagliflozin with be assessed alone and while taking glimepiride


Eligibility criteria:
inclusion criteria: * healthy subjects with bmi of 18-32 kg/m2 exclusion criteria: * abnormal physical or lab findings * allergies to any sulfonylurea or related compounds
heart failure and therapeutic education

Conditions: Heart Failure; Health Education; Diet, Sodium-Restricted; Disease Management; Therapeutics

Summary: this study looks at whether a special program called the heart failure therapeutic education unit (utic) helps reduce hospital stays for people with heart failure. it is a retrospective study, which means we are looking back at the records of patients who were followed at the utic in 2023 and 2024. we want to find out two things: if patients who followed the utic program were hospitalized less often. if the advice they received-especially about diet-helped improve their condition. only adult patients who were treated at the utic are included in the study. we will not use data from patients who are under 18, were not treated in utic, or did not give permission to use their information. the study takes place over two weeks, from march 24 to april 6, 2025.


Eligibility criteria:
inclusion criteria: * adults (age ≥ 18 years) * patients diagnosed with heart failure * patients followed in the heart failure therapeutic education unit (utic) at the general hospital (chg) * follow-up occurred during the years 2023 or 2024 exclusion criteria: * patients who do not consent to the use of their medical data * minors (under 18 years old) * patients not followed in the utic program
ldct-sc-fi low-dose ct screening for lung cancer

Conditions: Lung Cancer Screening

Summary: this is a randomized phase ii trial investigating different smoking cessation methods in study subjects undergoing lung cancer screening with low-dose ct (ldct). the study also evaluates feasibility and outcomes of ldct screening and potential biomarkers and ai-based evaluation on ct-scans. the study subjects fulfilling i/e-criteria are randomized in 1:1 fashion to yearly ldct for two rounds with standard smoking cessation (control) or same ldct approach combined to mobile application based smoking cessation (intervention).


Eligibility criteria:
inclusion criteria: * able to provide written informed consent * age between 50-74 * smoked ≥ 15 cigarettes/day for ≥ 25 years or smoked ≥ 10 cigarettes/day for ≥ 30 years and are active smokers (smoking during the last two weeks) * access to a smartphone (iphone or android) exclusion criteria: * a moderate or bad self-reported health; e.g. unable to climb two flights of stairs * body weight ≥ 140 kilogram * current or past melanoma, lung, renal or breast cancer * a chest ct examination less than one year before inclusion * has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial * subject is unwilling or unable to comply with treatment and trial instructions * any condition that study investigators consider an impediment to safe trial participation
the efficacy and safety of degarelix one month dosing regimens in prostate cancer

Conditions: Prostate Cancer

Summary: the study was a three-arm, active-control, multi-centre, parallel group study.


Eligibility criteria:
main inclusion criteria: * patients, aged 18 years or over, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated. * baseline testosterone \>1.5 ng/ml. * life expectancy of at least 12 months.

Keywords: prostate cancer
a trial to evaluate the safety and efficacy of ncr102 in subjects with agvhd

Conditions: Acute Graft-versus-Host Disease

Summary: evaluate the safety and efficacy of ncr102 injection in the treatment of sr-agvhd patients who have failed second-line therapy.

an open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability and preliminary efficacy of ncr102 injection in the treatment of sr-agvhd patients who have failed second-line therapy.

Eligibility criteria:
inclusion criteria: * age\>18 years and \<70 years old (including threshold), gender not limited； * grade ii to iv gastrointestinal involvement acute graft-versus-host disease(agvhd)； * subjects with steroid-refractory acute graft-versus-host disease(sr-agvhd)； * failed to second-line agvhd treatment; * subjects will receive ncr102 injection treatment within 3 days after enrollment; * voluntarily sign an informed consent form. exclusion criteria: * subjects have lung disease, and investigators have determined that they are not suitable for the study; * subjects with severe hepatic vein occlusion disease or sinus vein occlusion syndrome; * subjects with signs/symptoms of chronic gvhd; * subjects who are clinically assessed by the investigator could not be ruled out as having diarrhea caused by cytomegalovirus (cmv) enteritis, transplant related thrombotic microvascular disease (ta-tma), or digestive tract infection; * eastern cooperative oncology group(ecog)\>3； * subjects have other diseases or physiological conditions that may interfere with the evaluation results of this trial, or life-threatening complications； * subjects had active malignant solid tumors within the past 5 years； * subjects had a known history of severe allergies to blood products, or heterologous proteins.

Keywords: sr-agvhd ncr102 second-line treatment failure
observational study about patients diagnosed with nafld

Conditions: Nonalcoholic Fatty Liver Disease

Summary: nonalcoholic fatty liver disease (nafld) is the most common condition affecting the liver, owing to its association with obesity and the metabolic syndrome. the largest study to date using magnetic resonance spectroscopy to quantify liver triglyceride (tg) content showed that approximately 33% of individuals have hepatic steatosis. nafld encompasses a continuum of histological findings that starts with steatosis that can progress to nonalcoholic steatohepatitis (nash), which is characterized by inflammation and cell death, and eventually cirrhosis. given the large number of individuals afflicted with this condition, there is a clear need to develop effective and safe therapies to treat nafld.

patients with nafld were recruited in the current study and divided into nafld group, and nash group. the researchers will collect various clinical examination indexes of the subjects in the process of diagnosis and treatment, including but not limited to alt, ast, tg, tc, etc. characteristic and prognosis of patients will be recorded. the serum, feces, urine and liver (if necessary) samples of all subjects will be taken after enrollment and stored for probably testing in the future. this study has no additional intervention and treatment for subjects.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with nonalcoholic fatty liver disease exclusion criteria: 1. patients suspected of excessive alcohol consumption 2. malignant tumors, dementia, active tuberculosis, aids, organ failure, pregnancy or breastfeeding, etc cannot cooperate with the investigation 3. incomplete data such as hbv serological results and abdominal ultrasound results 4. patients who refuse to sign informed consent

Keywords: nonalcoholic fatty liver disease
psoriatic arthritis dose ranging study for bms-945429 in subjects who are not responding to nsaids or non-biologic disease modifying anti-rheumatic drugs (dmards) therapy

Conditions: Arthritis, Psoriatic

Summary: the purpose of this study is to characterize the safety, efficacy and dose response of bms-945429 in subjects with active psoriatic arthritis and an inadequate response to nonsteroidal anti-inflammatory drugs (nsaids) and non-biologic disease modifying anti-rheumatic drugs (dmards).


Eligibility criteria:
inclusion criteria: * must be on a stable background methotrexate (mtx) therapy prior to day1/randomization. subjects must have taken mtx for at least 3 months at a dose ≥ 15 mg/week to a maximum weekly dose of ≤ 25 mg/week, and be at a stable dose for 4 weeks prior to randomization (day 1). methotrexate dose ≥ 15 mg/week that was not efficacious and that was decreased due to toxicity as low as 10 mg/week is allowed * inadequate response to nsaid and/or non-biologic dmard * minimum of 3 swollen and 3 tender joints * active psoriatic skin lesions over minimum 3% body surface area * high sensitivity c-reactive protein (hscrp) ≥ 0.3 mg/dl exclusion criteria: * previously received or currently receiving concomitant biologic therapy
pharmacodynamic study of biib095 and biib074 in healthy participants and participants with painful diabetic polyneuropathy

Conditions: Healthy Volunteers; Diabetic Neuropathies

Summary: part a: primary objective is to determine the effects of biib095 on nerve excitability in healthy participants. secondary and exploratory objectives include determining the effects of biib095 on nerve excitability in diabetic polyneuropathy (dpn) and assessing the safety, tolerability and pharmacokinetics of biib095. part b (optional): equivalent objectives are pursued for biib074.


Eligibility criteria:
key inclusion criteria: * healthy participants must be in good health, as determined based on medical history and screening evaluations * participants with dpn * must have a documented diagnosis of type 2 diabetes mellitus (dm) * must have stable glycemic control * must have at least clinical evidence of painful dpn * pain related to dpn must be present for at least 6 months prior to screening * average daily pain intensity over 7 consecutive days recorded during screening must be ≥ 4 on an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain imaginable) key exclusion criteria: * any neurologic or painful condition that could confound the interpretation of study results * history of any clinically significant cardiac, hematologic, hepatic, immunologic, urologic, pulmonary, dermatologic, psychiatric, renal, or other major disease. this includes any clinically significant endocrinologic or neurologic disease other than dm or dpn. * use of local anesthetics or capsaicin for topical or regional treatment within 3 months prior to screening. * systemic use of sodium channel inhibitors note: other protocol-specific inclusion/exclusion criteria may apply.
assessment of nutritional status and role of insulin-like growth factor-1 in children

Conditions: Thalassemia

Summary: many studies done on children with thalassemia have shown a variable prevalence of defective igf-i concentrations have been shown to be low in the majority of children, with or without gh deficiency. the aim of this study to assess nutritional status and role of insulin-like growth factor 1 (igf-1) and its associating factors in children with thalassemia major


Eligibility criteria:
inclusion criteria: * children in the age group of 2-18 years with confirmed diagnosis of beta thalassemia major. exclusion criteria: * children with other chronic diseases (cardiac, renal, vascular) * children with malignancy

Keywords: insulin-like growth factor 1
methotrexate as a steroid-sparing agent in idiopathic retroperitoneal fibrosis: a randomised, multicenter trial

Conditions: Idiopathic Retroperitoneal Fibrosis; Perianeurysmal Retroperitoneal Fibrosis; Chronic Periaortitis

Summary: chronic periaortitis is a clinico-pathological entity encompassing idiopathic retroperitoneal fibrosis and perianeurysmal retroperitoneal fibrosis. the treatment of this disease is generally based on the use of glucocorticoids, which are often effective. however, prolonged steroid treatments are usually needed to achieve a sustained remission; additionally, patients frequently develop disease relapses following treatment discontinuation, therefore they may be exposed to high cumulative doses of glucocorticoids. preliminary data reported in the literature show that methotrexate may be effective in combination with prednisone for retroperitoneal fibrosis. in addition, methotrexate is often used as a steroid-sparing agent in different inflammatory diseases. the aim of this study is to evaluate whether a treatment with low-dose prednisone plus methotrexate is non-inferior to conventional dose-prednisone in achieving remission in retroperitoneal fibrosis patients.


Eligibility criteria:
inclusion criteria: * new diagnosis of idiopathic retroperitoneal fibrosis or chronic periaortitis; written informed consent exclusion criteria: * secondary forms of retroperitoneal fibrosis (e.g. drugs, surgery, neoplasms, infections) * previous medical therapy for retroperitoneal fibrosis * renal failure with creatinine \>2 mg/dl which proved not to be reversible after ureteral decompression * hypersensitivity to the study drugs * pregnancy * active infections or malignant neoplasms

Keywords: retroperitoneal fibrosis inflammatory aneurysms methotrexate prednisone aorta