Kornimate/medical-research-clean huggingface dataset:
a study to investigate long-term safety and tolerability of itepekimab in participants with copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this is a parallel, double blind, phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional pk and immunogenicity assessments. the primary purpose of this study is to evaluate safety and tolerability of both itepekimab sc q2w or itepekimab sc q4w in participants with copd having completed the treatment period of the clinical studies efc16750 or efc16819. a secondary purpose of this study is to provide efficacy outcomes beyond the treatment period of the parent trials efc16750 and efc16819. study details include: * the study duration will be up to 72 weeks * the treatment duration will be up to 52 weeks * a follow-up period of 20 weeks will be conducted * the number of on-site visits will be 7 and the number of phone contacts will be 5


Eligibility criteria:
inclusion criteria: - patients with copd who completed the treatment period in a previous itepekimab copd phase 3 clinical study (ie, efc16750 or efc16819) and for which an end-of-treatment (eot) visit occurred no later than 3 days before the enrolment visit of this study. exclusion criteria: * diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma of the skin * any opportunistic infection during the parent study, such as tuberculosis (tb) or other infections whose nature or course may suggest an immunocompromised status * anaphylactic reactions or systemic allergic reactions that are related to imp and require treatment during the parent study * any situation that led to a permanent premature imp discontinuation in parent trials the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
toripalimab in combination with platinum plus etoposidein patients with extensive-stage small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: this is a phase iii, multicenter, double-blinded, placebo-controlled study of platinum（cisplatin or carboplatin） plus etoposide with or without toripalimab as first line therapy in patients with extensive stage small cell lung cancer. the purpose of this study is to evaluate the safety and efficacy of toriplimab in combination with platinum（cisplatin or carboplatin） plus etoposide in treatment naive extensive stage small cell lung cancer. participants will receive asigned study treatment until progressive disease (pd) as assessed by the investigator using response evaluation criteria in solid tumors version 1.1 (recist v1.1).


Eligibility criteria:
inclusion criteria: 1. ≥18 years , male or female; 2. histologically or cytologically confirmed es-sclc (per the veterans administration lung study group (valg) staging system 3. ecog ps 0\~1; 4. no prior treatment or immunocheckpoint inhibitors for es-sclc; 5. treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage sclc； 6. patients with asymptomatic brain metastases who have received previous treatment 7. has provided tumor tissue samples 8. estimated survival time ≥8 weeks; 9. there is at least one measurable lesion that conforms to recist criteria v1.1.for lesions that have received previous radiation therapy, the lesion can only be included in the measurable lesion if the disease progression is clear after radiotherapy and the lesion is not the only measurable lesion. 10. before the first dose of the study drug, it should have appropriate organ function, and the laboratory test value should meet the protocol. 11. has adequate hematologic and end organ function exclusion criteria: 1. prior systemtic treatment for es-sclc; 2. prior treatment with any cd137 agnist or immunocheckpoint inhibitors. 3. subjects with active or untreated central nervous system (cns) tumor metastasis; 4. spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 1 week prior to randomization 5. cancerous meningitis; 6. uncontrolled or symptomatic hypercalcemia; 7. other malignant tumors within 5 years prior to the first dose of study treatment 8. subjects with any active, known or suspected autoimmune disease; 9. history of idiopathic pulmonary fibrosis, drug-induced pneumonitis,or evidence of active pneumonitis . 10. subjects who received major surgery within 28 days prior to enrollment or were not fully recovered from prior surgery; 11. significant cardiovascular disease, such as new york heart assoc
the effects of omega 3 and vitamin e supplementation on the serum antioxidant enzymes and gene expressions of pgc-1a, h tert, foxos and sirts in cad patients

Conditions: Coronary Artery Disease

Summary: the aim of this study is to determine the effects of omega 3 supplementation and its concurrent supplementation with vitamin e on the serum levels of antioxidant enzymes and the expressions of the pgc-1a, h tert, foxo1, foxo3a , sirt1,sirt3, sirt6 genes in pbmc cells in the patients with coronary artery disease


Eligibility criteria:
inclusion criteria: - literate, willingness to participation, cad patients 45- 65 years old, body mass index\< 30, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention, willing to maintain body weight during the study exclusion criteria: * people who have used vitamin e or omega 3 supplements in last 3 months, having chronic renal disease ,cancer, hepatobilliary diseases, hematological disorders, hypo- or hyperthyroidism, diabetes, treatment with ppar-gamma agonists or thiazolidinediones, smokers

Keywords: antioxidant enzymes omega 3 vitamin e cad sirtuins foxos
effect of sleep disorder on the development of lung tumors

Conditions: Sleep Disorder, Lung Tumor

Summary: the goal of this observational study is to observe the lung tumor development in lung tumor patients with long-term sleep disorder. the main questions it aims to answer are: * will long-term sleep disorder promote the malignancy of lung tumor * if so, how exactly will the microenvironment of lung tumor change participants will receive psqi scale and mri functional brain imaging before surgery, blood and tumor tissue will be collected during the surgery. researchers will set non-sleep disorder group as control group to see if lung tumor microenvironment change when long-term sleep disorder exists in lung tumor patiens.


Eligibility criteria:
inclusion criteria: * 18-75 years old * elective sublobectomy for primary lung tumor * asa grade i-ii * informed consent of the patient or family exclusion criteria: * combination of serious heart, liver, kidney, central nervous system, blood system, immune system diseases or serious mental illness * combination of other cancers * untreated active lung infection * patients with preoperative neoadjuvant radiotherapy
the correlation between filling pressure, cardiac output and plasma copeptin in patients with systolic heart failure

Conditions: Heart Failure

Summary: the relationship between the activation of the vasopressin system and central hemodynamics in heart failure (including right and left heart filling pressures and cardiac output) is not clear. the investigators intend to examine the correlation between levels of copeptin and vasopressin and the central hemodynamic system in patients with advanced (class iii or iv) heart failure. the investigators also aim to examine the relationship of selected cardiac biomarkers in blood and urine with cardiac filling pressures and cardiac output in patients with decompensated heart failure. the study population will consist of 30 patients admitted to the department of cardiology at copenhagen university hospital. only patients for whom the attending cardiologist has already decided upon right heart catheterization for clinical/treatment reasons will be recruited for the study.


Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. left ventricular ejection fraction \< 40 % 3. diagnosed symptomatic heart failure treated with heart failure medications for at least 30 days. 4. clinical indication for right heart catheterization for clinical/treatment reasons 5. nyha-class iii-iv 6. relevant heart failure treatment as tolerated by the patient exclusion criteria: 1. absence of clinical/treatment indication of right heart catheterization 2. syndrome of inappropriate secretion of adh (siadh) 3. recent acute myocardial infarction within the last 30 days 4. presence of infection or inflammatory disease 5. malignant disease 6. pregnancy 7. subjects unwilling or unable to provide written consent
a multi-center, prospective, randomized study with primatrix and primatrix ag for the treatment of venous leg ulcers

Conditions: Venous Stasis Ulcer

Summary: to evaluate the effectiveness of primatrix, primatrix ag, and standard of care in the treatment of venous leg ulcers (vlus).

healing percentages

Eligibility criteria:
inclusion criteria: * men or women ≥ 18 years of age * ankle-brachial index (abi) \> 0.80 * study wound 2-64 cm2 surface area * wound does not exhibit a greater than 50% reduction in surface area during the screening period exclusion criteria: * suspected or confirmed signs/symptoms of wound infection * hypersensitivity to bovine collagen * body mass index (bmi) ≥ 45
a study of hgs1029 (aeg40826-2hcl) in subjects with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the purpose of this study is to evaluate the safety and tolerability of hgs1029 in subjects with advanced solid tumors and to determine a phase 2 dose.


Eligibility criteria:
inclusion criteria: * confirmed advanced solid malignancy * life expectancy of at least 3 months * age 18 years or older * acceptable liver function * acceptable renal function * acceptable hematologic status exclusion criteria: * received investigational (not yet approved by a regulatory authority)agent within 4 weeks before enrollment. * received non-investigational agent within 3 weeks before enrollment. * progressive cns involvement including the need of corticosteroids * pregnant or breast-feeding women * active, uncontrolled bacterial, viral, or fungal infections within 2 weeks of cycle 1 day 1 * known hiv infection
memory enhancement by gamma-hydroxybutyrate vs. trazodone in major depressive disorder.

Conditions: Major Depressive Disorder

Summary: 30 healthy adults and 30 patients with major depressive disorder, will take part in three single-application pharmacological interventions (ghb vs. trazodone vs. placebo p.o.) to test potential effects of these drugs on nocturnal memory consolidation. all participants will be assessed with mood state questionnaires, tests of emotional, procedural and declarative memory consolidation, polysomnography, eeg and neuroinflammatory biomarkers. at experimental nights, learning tasks are performed prior to sleep. the next morning, recalling tasks are performed. each subject will pass through 5 study nights (1 screening, 1 adaptation and 3 experimental nights).


Eligibility criteria:
arm 1 (healthy controls): * healthy participants, * non-smoker, * age 20-65 years arm 2 (patients with depression): * diagnosis of major depression (dsm-v), * selective serotonin-reuptake-inhibitor (ssri) or selective serotonin-noradrenalin-reuptake-inhibitor (ssnri) medication, * age 20-65 years
radiation oncology patient medical physics intervention study

Conditions: Anxiety; Patient Satisfaction; Radiation Therapy

Summary: this investigation is designed to be a two-arm, non-randomized prospective phase 2 study evaluating the impact of medical physicist patient intervention on the anxiety level and patient satisfaction of patients undergoing a course of radiation therapy. the goal is to demonstrate that these interventions will have a significantly positive impact on the overall well-being of the oncology patients.


Eligibility criteria:
inclusion criteria: * age \>/= 18 years * patients receiving treatment in the outpatient setting. * patients with an eastern cooperative oncology group performance status (ecog ps) 0, 1, or 2. exclusion criteria: * patients receiving a single fraction of treatment. * history of prior radiation.
long-term safety and efficacy study of avanafil in men with erectile dysfunction

Conditions: Erectile Dysfunction

Summary: this open-label study is being conducted to evaluate the long-term safety, tolerability, and efficacy of avanafil in men with mild to severe erectile dysfunction. approximately 400 subjects will be enrolled and treated with avanafil for up to 52 weeks.


Eligibility criteria:
inclusion criteria: * successfully completed the entire treatment period in a qualifying study (ta-301 \[nct00790751\] or ta-302 \[nct00809471\]); * demonstrated compliance with the study protocol, including drug administration, diary completion, and scheduled study visits, during the qualifying trial; * made at least 4 attempts at intercourse during the last treatment period of the qualifying trial; * agree to make at least 4 attempts at intercourse each month through the course of this study; * agree not to use any other treatments for erectile dysfunction during participation in this study. * provide written informed consent; * willing and able to comply with scheduled study visits, treatment plan, laboratory tests, and other study procedures. exclusion criteria: * subjects who, in the opinion of the investigator, have developed one or more comorbidities during the qualifying study that would pose a safety concern to their continuation on treatment in study ta-314; * subjects requiring treatment with an excluded medication.

Keywords: ed erectile dysfunction dysfunction erectile
effect of omega-3 fatty acid on endothelial function

Conditions: Familial Hypercholesterolemia

Summary: background familial hypercholesterolemia (fh) is an inherited disease in which the level of bad cholesterol (ldl-cholesterol) is increased, leading to an increase in coronary heart disease even if adequately treated with cholesterol lowering medication (statins). polyunsaturated fatty acids (pufa) including omega-3 is known to affect the risk for coronary disease, however its effect on patients with fh is not known. the purpose of the study is to assess the effect of pufa on patients with fh, with regard to inflammation measured in the blood and the effect on the blood vessels'ability to relax (endothelial function) by means of tonometry. hypothesis treatment with 4 grams of pufa a day for 4 months will lead to an improvement in the endothelial function, and the treatment will also lead to a decrease in in several markers of inflammation and in lipids in the blood.


Eligibility criteria:
inclusion criteria: * documented familial hypercholesterolemia * age 18-60 years * on statin treatment for at least 12 months exclusion criteria: * pregnancy or planned pregnancy * breast feeding * cancer * non-compliance * pufa/omega-3 \< 3 months before inclusion
behavioral and pharmacologic treatment of binge eating and obesity: specialist treatment

Conditions: Binge-Eating Disorder; Obesity

Summary: this study will test the effectiveness of cognitive-behavioral therapy as a specialist treatment for binge eating disorder (bed) in patients with obesity. this is a controlled test of whether, amongst non-responders to acute treatments, cognitive-behavioral therapy augments on-going blinded pharmacotherapy (either naltrexone/bupropion or placebo), compared with no additional behavioral treatment .

binge eating disorder (bed), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. improved treatments for patients with obesity and bed are needed that can produce sustained clinical outcomes and promote weight loss. this study (specialist treatment) rct will provide new and novel findings from a controlled test, amongst non-responders to acute treatments, whether cognitive-behavioral therapy augments on-going blinded pharmacotherapy (naltrexone/bupropion or placebo) compared with on-going pharmacotherapy alone (without added cognitive-behavioral therapy).

Eligibility criteria:
inclusion criteria: * participated in acute treatment for binge-eating disorder and obesity; * did not have a positive response to acute treatment; * available for the duration of the treatment and follow-up (20 months); * read, comprehend, and write english at a sufficient level to complete study-related materials; and * able to travel to study location (new haven, ct) for weekly visits. exclusion criteria: * currently taking anti-depressant medications; * currently taking opioid pain medications or drugs; * currently taking medications that influence eating/weight; * history of seizures; * current substance use disorder or other severe psychiatric disturbance (e.g., suicidality); * past or current anorexia nervosa, bulimia nervosa; * pregnant or breastfeeding; * medical status judged by study physician as contraindication.
retinal thickness and volume estimates given by time domain and spectral optical coherence tomography

Conditions: Healthy; Diabetic Maculopathy

Summary: the purpose of the present study is to determine if the retinal thickness estimates of the stratus oct, the 3d oct-1000, and the cirrushd oct are comparable in diabetic and in healthy individuals (oct=optical coherence tomography).


Eligibility criteria:
inclusion criteria: * diabetic retinopathy in the diabetic group * healthy retinas in the healthy group exclusion criteria: * not able to cooperate * retinal disease other than macular oedema * severe media opacities (e.g. cataract) * prior macular laser photocoagulation except for large oedemas
corneal toxicity in patients treated by belantamab mafodotin

Conditions: Myeloma Multiple

Summary: belantamab mafodotin is the first antibody conjugate targeting b-cell maturation antigen (bcma) in relapsed or refractory multiple myeloma (rrmm). it is used in multiple myeloma refractory to an immunomodulatory drug or proteasome inhibitor and refractory and/or intolerant to an anti-cd38 monoclonal antibody. it has been found that the immunotherapy causes corneal side effects, microcyst-like epithelial changes (mecs). they are round-shaped corneal inclusions that migrate from the peripheral cornea to the center, causing blurry vision, dryness and refractive shifts depending on their location and density.

this study aims at analysing the refractive shifts caused by microcyst-like epithelial changes (mecs) and whether it can be used to monitor patients and facilitate their follow up. constitution of a french multicenter cohort.

Eligibility criteria:
inclusion criteria: * french patients with a refractory multiple myeloma and an ophthalmologic follow-up between january 2020 and february 2022 * patients treated by belantamab mafodotin exclusion criteria: * patients with more than 50% of missing ophthalmologic data.

Keywords: myeloma relapsed or refractory multiple myeloma (rrmm) belantamab mafodotin microcyst-like epithelial changes (mecs) microcyst corneal toxicity refractive shift
synergistic innovative functional food concepts to neutralize inflammation for cardiometabolic risk prevention

Conditions: Cardiometabolic Risk; Abdominal Obesity

Summary: the aim of the study is to evaluate the synergistic effects of daily consumption of food products fortified with bioactive components (fibres, polyphenols, omega-3, slow digestible starch) for 9 weeks, compared to the daily intake of standard food products on low-grade inflammation in cardiometabolic risk subject. the inflammatory parameters will be assessed in fasting and in postprandial period after the consumption of a hyper-carbohydrate and hyper-lipidic test meal called flexmeal. a metabolic stress will be induced by a fructose ingestion challenge during the last 6 days of interventional period.


Eligibility criteria:
inclusion criteria: * healthy men and women * body mass index of 25 to 35 kg/m2 * waist circumference greater than 80 cm for women and than 96 cm for men * daily biscuits consumption * fibers intake \<25g/day exclusion criteria: * medical history of digestive surgery or disease * large polyphenols food products consumer (cranberries, red berries, coffee, tea, red wine, fruits and vegetables...) * current or recent (\<12 weeks) intake of antibiotics or gastro-intestinal medicinal product * current probiotics, prebiotics, fibers complement, and/or any products modulation gut transit * feeding particular diet such as vegetarian diet or hyperprotein diet * current weight loss diet * pregnant or lactating woman or woman who did not use effective contraception * drinking more than 3 glasses of alcohol per day (\>30g/day) * smoking more than 5 cigarettes per day

Keywords: inflammation cardiometabolic risk endotoxemia polyphenols oxidative stress slow digestible starch fibers gut microbiota nutritional challenge test
yoghurt consumption, body weight management and glycemic control of t2dm patients

Conditions: Type 2 Diabetes Mellitus

Summary: the study investigates the effects of consumption of yoghurt enriched with vitamins b compared to plain yoghurt, on body weight management and glycemic control of overweight/obese t2dm patients. it also investigates the effect of plain yoghurt consumption on gut hormones response of t2dm patients.

in a large number of epidemiological studies, low-fat dairy consumption has been associated with lower risk of t2dm. however, the number of randomized clinical trials which examine the impact of yoghurt consumption on glycemic control and body weight management of t2dm patients is small and include yoghurts fortified with vitamin d or probiotics. according to our knowledge, fortification of yoghurt with other classes of vitamins beyond vitamin d has not been examined. vitamins of b-complex hold key-role in energy metabolism. in the state of diabetes mellitus, the requirements for this vitamin class may be higher because of their water solubility and increased excretion. two groups of patients participated in the study. one group received yoghurt enriched with vitamins b and one group received isocaloric plain yoghurt. in addition, in order to investigate the effect of plain yoghurt on gut hormones, responses to a mixed meal tolerance test were evaluated in the beggining and the end of the dietary intervention.

Eligibility criteria:
inclusion criteria: * bmi 27-36 * hba1c \< 8.5% * constant body weight and dietary habits for the last 3 months * stable dose of oral medication for at least 3 months * diagnosed with t2dm for more than 1 year exclusion criteria: * history of cardiovascular, gastrointestinal, renal and endocrinological diseases * treatment for weight reduction * lactose intolerance * allergies to milk and dairy products * alcohol consumption (\> 2 drinks per day) * intake of supplements * receiving insulin

Keywords: yoghurt vitamins b body weight glycemic control
duotrav® eye drops as replacement therapy program

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: to evaluate the effectiveness of duotrav eye drops in gaining or maintaining control of target intraocular pressures (tiop) in patients diagnosed with, and being treated for, open-angle glaucoma (oag) or ocular hypertension (oh).


Eligibility criteria:
inclusion criteria: * patients with oag or oh for whom single agent therapy provides insufficient intraocular pressure reduction exclusion criteria: * none

Keywords: glaucoma iop duotrav