Kornimate/medical-research-clean huggingface dataset:
a study of monthly intravenous c.e.r.a. (mircera) in hemodialysis participants with chronic renal anemia

Conditions: Anemia

Summary: this single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous methoxy polyethylene glycolepoetin beta (mircera) for the maintenance of hemoglobin levels in hemodialysis participants with chronic renal anemia. participants currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will receive intravenous mircera at a starting dose of 120, 200 or 360 micrograms/month (based on the erythropoietin stimulating agent \[esa\] dose administered on week -1). subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to12 gram per deciliter (g/dl). the anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * chronic renal anemia; * continuous intravenous maintenance erythropoietin stimulating agent (esa) treatment during previous month; * regular long term hemodialysis therapy with the same mode of dialysis for \>=3 months. exclusion criteria: * transfusion of red blood cells during previous 2 months; * significant acute or chronic bleeding, such as overt gastrointestinal bleeding; * active malignant disease (except non-melanoma skin cancer).
fatty acid biomarkers of carbohydrate intake

Conditions: Dyslipidemias

Summary: the overall aim is to investigate if circulating fatty acids and lipids are influenced by alterations in carbohydrate amount and quality.

in this isocaloric clinical cross-over trial, the investigators aim to investigate if circulating fatty acids and lipids are influenced by alterations in carbohydrate amount and quality. the investigators intend to evaluate if changes in carbohydrate quantity and quality (including sugar) influence circulating even-chain saturated fatty acids or if fatty acid-derived indices of desaturation and de novo lipogenesis are more sensitive biomarkers of carbohydrate intake. by performing untargeted lipidomic analyses, the investigators aim to search for novel lipid biomarkers of carbohydrate quantity and quality. the investigators also want to evaluate the influence of moderate alterations of carbohydrate and sugar intake on lipoproteins, insulin sensitivity, inflammatory proteins.

Eligibility criteria:
inclusion criteria: * bmi 20-38 exclusion criteria: * abnormal lab tests (assessed by screening and judged by a physician), diabetes, cardiovascular, kidney, liver or malignant disease, and weight-loss (±3kg) the preceding 3 months of screening. extreme diets, i.e. very-low carbohydrate diets, intermittent fasting, vegan diets or allergic to gluten

Keywords: fatty acids biomarker carbohydrate lipogenesis
neoadjuvant chemotherapy with or without huaier granule in treating women with locally advanced breast cancer that can be removed by surgery

Conditions: Breast Cancer

Summary: rationale: huaier (trametes robiniophila murr) is a traditional chinese medicine, which has been widely used in china for many years. the investigators have found that huaier could exert synergistic effects with epirubicin, cyclophosphamide, and paclitaxel on breast cancer cells. it is not yet known whether combination chemotherapy is more effective when given together with huaier in the neoadjuvant setting . purpose: to evaluate the effects of treatment with huaier granule in managing locally advanced breast cancers with synergistic action of the neoadjuvant chemotherapy.


Eligibility criteria:
* inclusion criteria: * age: ≥ 18, female; * breast cancer (tnm ii, iii, iv) larger than 2cm in maximal diameter able to benefit from neoadjuvant chemotherapy; * ductal or lobular histological type of the breast tumor; * the diagnosis and breast cancer has been confirmed by pathological examination; * the liver and kidney function satisfies the following conditions within 3 days after surgery (excluding day 3): aspartate aminotransferase (ast), glutamic-oxalacetic transaminase (alt) \< 2 upper limit of normal (uln), total bilirubin ≤ 1.5 uln, serum creatinine \< 1.5 uln; * other laboratory tests meet the following requirements within 3 days after surgery (excluding day 3): hb ≥ 90g/l, platelet count ≥ 100×109/l, absolute neutrophil count \> 1.5×109/l; * the expected survival time ≥ 8 months; * the subjects volunteer to sign the informed consent. * exclusion criteria: * breast cancers of rare histological type (other than ductal and lobular); * noninvasive cancer; * presence of organ, bone, or skin metastases; * pregnant or lactating women; * those with active bleeding due to various reasons; * those with hiv infection or aids-associated diseases; * those with severe acute and chronic diseases; * those with severe diabetes; * those with serious infectious diseases; * those who can not take drugs by oral route; * drug abusers or those with psychological or mental diseases that may interfere with study compliance; * conditions that are considered not suitable for this study investigators
24-hr intraocular pressure control with simbrinza ®

Conditions: Glaucoma

Summary: the purpose of this study is to evaluate differences between treatments in mean change from baseline in 24-hr intraocular pressure (iop) at week 4.

subjects will undergo washout of pre-study iop-lowering medications for the appropriate duration, then undergo 2 eligibility visits. eligible subjects will be randomized 1:1, to receive masked simbrinza ® or vehicle for 4 weeks. two 24-hour visits will be conducted (day 0 and week 4) during which intraocular pressure will be collected every 2 hours. the expected duration of subject participation in the study is 10 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of either open-angle glaucoma or ocular hypertension; * able to attend all study related visits and be housed overnight at clinical site for the study assessments; * willing and able to sign an informed consent form; * other protocol-specified inclusion criteria may apply. exclusion criteria: * women of childbearing potential who are pregnant, intend to become pregnant during the study, breast-feeding, or not using adequate birth control; * diagnosed with any form of glaucoma other than open angle glaucoma or ocular hypertension; * ocular surgeries or procedures excluded by the protocol; * diseases, illnesses, infections, or ocular abnormalities excluded by the protocol; * best-corrected visual acuity score less than 55 etdrs letters (equivalent to approximately 20/80 snellen) in either eye; * other protocol-specific exclusion criteria may apply.
a study of cemdisiran in adults with immunoglobulin a nephropathy (igan)

Conditions: IgA Nephropathy (IgAN); Berger Disease; Glomerulonephritis, IgA

Summary: the purpose of this study is to evaluate the effect of cemdisiran on proteinuria in adults with immunoglobulin a nephropathy (igan), who excrete \>1 gram (gm) of protein per day despite standard of care, which includes treatment with angiotensin-converting enzyme (ace) inhibitors or angiotensin receptor blockers (arb). these participants are at high risk for progression of kidney disease, which can result in end-stage renal failure.


Eligibility criteria:
inclusion criteria: * diagnosed with primary igan * currently being treated for igan with stable, optimal therapy, including an ace inhibitor or arb. * has urine protein greater than or equal to 1 gram/24-hour * has hematuria (blood cells present in urine) exclusion criteria: * has renal disease other than igan * has a diagnosis of rapidly progressive glomerulonephritis * has a diagnosis of henoch-schonlein purpura (iga vasculitis) * has poor kidney function with estimated glomerular filtration rate (egfr) \<30 milliliters per minute per 1.73 meters square (ml/min/1.73 m\^2) * has known human immunodeficiency virus (hiv) infection, hepatitis c virus (hcv) infection or hepatitis b virus (hbv) infection * has on-going high blood pressure * treated with systemic corticosteroids for more than 7 days, or other immunosuppressant agents in the past 6 months * received an organ transplant
single patient compassionate use of x-pact in salvage treatment of prostate cancer

Conditions: Prostate Cancer

Summary: due to the subject's lack of conventional treatment options, a treatment plan using x-pact administered intra-tumorally is proposed. x-pact (x-ray psoralen activated cancer therapy) is comprised of a phosphor device (an energy modulation agent), methoxsalen sterile solution (a psoralen), x-ray energy and represents a potential new approach for the treatment of solid tumors. methoxsalen is a psoralen found in the seeds of the ammi majus (umbelliferae) plant. importantly, methoxsalen (whether formulated as the sterile solution \[uvadex®\] or as a hard gelatin capsule \[8-mop®\]) can promote a strong long-term clinical response, as observed in the treatment of cutaneous t cell lymphoma (ctcl) utilizing extracorporeal photopheresis (ecp) and is approved by the united states food and drug administration \[us fda\] for this indication. in ecp, malignant ctcl cells are irradiated with uva light in the presence of methoxsalen and then re-administered to the patient. x-pact may offer the potential for local control of primary or metastatic disease via administration of the combination product of methoxsalen and powerful energy converters (phosphors) when activated by x-ray beam. in addition, there is numerous data in support of an immunogenic role for activated methoxsalen. the cytotoxic and immunogenic effects of psoralens are often attributed to psoralen mediated photo-adduct dna damage \[1\]. a principle mechanism underlying the long term immunogenic clinical response likely derives from psoralen induced tumor cell cytotoxicity and uptake of the apoptotic cells by immature dendritic cells, in the presence of inflammatory cytokines \[2, 3 4, 5\]. however, photochemical modification of proteins and other cellular components can also impact the antigenicity and potential immunogenicity of treated cells \[6\]. the diversity and potency of psoralen application is further illustrated by recent success using psoralen in the development of virus vaccines \[7\]. the immunogenic activity of methoxsalen supports a potential abscopal effect for x-pact particularly as it incorporates both radiation and an immunotherapeutic.


Eligibility criteria:
inclusion criteria: the patient is willing and able to provide informed consent. only the patient for whom this clinical study/experimental treatment was designed will be given the investigational drug under the treatment of the pi. no other patient is authorized to participate in or to receive treatment under this treatment protocol. exclusion criteria: not applicable
special drug use investigation for paxil tablet (long-term)

Conditions: Mental Disorders

Summary: this surveillance study is designed to detect adverse events (particularly clinically significant adverse drug reactions) occurring in clinical settings and to examine factors likely to affect the safety and efficacy of paroxetine in long-term use (1 year).


Eligibility criteria:
inclusion criteria: * patients with depression/depressed state or panic disorder * paxil must be used for long-term exclusion criteria: * patients who had been taking paxil since before the start of the survey * patients with hypersensitivity to paroxetine * patients taking monoamine oxidase inhibitors (maois) or within 2 weeks of stopping treatment with maois * concomitant use in patients taking pimozide
short-term study of combination treatment of escitalopram and gaboxadol in major depressive disorder

Conditions: Major Depressive Disorder

Summary: to compare the efficacy of escitalopram fixed dose 20 mg/day in combination with fixed doses of gaboxadol (5 and 10 mg/day) versus escitalopram fixed dose 20 mg/day after 8 weeks of treatment in patients with major depressive disorder

subjects participating in this study will be respectively randomised (1:2:2:2) to receive either: * placebo or * escitalopram 20 mg/day or * escitalopram 20 mg/day in combination with gaboxadol 5 mg/day or * escitalopram 20 mg/day in combination with gaboxadol 10 mg/day

Eligibility criteria:
inclusion criteria: clinical diagnosis of mdd according to dsm-iv-tr criteria: * with reported duration of the current major depressive episode of at least 3 months * with madrs total score of at least 30 exclusion criteria: the patient has 1 or more of the following: * any current psychiatric disorder other than mdd as defined in the dsm-iv-tr * current or past history of: manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the dsm-iv-tr * any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the dsm-iv-tr * presence or history of a clinically significant neurological disorder (including epilepsy) * neurodegenerative disorder (alzheimer disease, parkinson disease, multiple sclerosis, huntington disease, etc) * any axis ii disorder that might compromise the study * previous use of hallucinogenic drug the patient has a significant risk of suicide according to the investigator's opinion, or has a score \>=5 on item 10 (suicidal thoughts) of the madrs, or has made a suicide attempt in the previous 12 months.
endometriosis transcriptomic cell atlas

Conditions: Endometriosis; Infertility

Summary: endometriosis is an estrogen-dependent, chronic inflammatory gynecologic disease affecting women of reproductive age, with a therapeutic wandering of 6 to 10 years. a better understanding of the initiation phase is a major challenge to improve diagnosis and treatment. the most widely accepted hypothesis to explain the formation of endometriotic lesions is the tubal retrograde reflux during menstruation. however, only 10% of the reproductive age women will develop endometriosis while 90% of women experience retrograde menstruation. this raises the question of the stem cells present in the endometrium and menstrual reflux of these patients, but also of both the peritoneal microenvironment and the estrogenic local signaling which allow the implantation of these lesions.

using tissues collected at different phases of menstrual cycle in healthy women and patients operated for endometriotic lesions, 3 main objectives : 1. to characterize cellular heterogeneity between eutopic endometrium and ectopic lesions in parallel with peritoneal fluid to identify potential stem cells and the immune microenvironment in order to find new biomarkers (using a combination of unbiased transcriptomic, spectral flow cytometry and multiplex imaging analysis) 2. to develop organoid models that integrate peritoneal fluid elements (supernatant and/or cells) to clarify stem cell properties/characteristics and their supportive environment 3. to leverage the use of these endometrial derived-organoids to functionally study the differential influence of estrogen signaling in women with or without endometriosis

Eligibility criteria:
inclusion criteria: * patients over 18 and under 45 years of age * patients with multiple endometriosis sites (superficial, deep and endometriomas) with an indication for surgery to treat disabling painful symptoms and stage iii or iv endometriosis in the context of infertility. * healthy patients including those operated on between the ages of 18 and 45 for tubal ligation * healthy patients operated on between the ages of 18 and 45 for hysterectomies for benign causes other than endometriosis or adenomyosis * patients operated on strictly at the time of menstruation * participants who have not been on hormonal treatment for 2 months * participant having signed the free and informed consent form * membership of a social security scheme or equivalent exclusion criteria: * patients with endometriosis non-surgically treated * patients with endometriosis receiving hormonal treatment at the time of surgery or having received hormonal treatment in the 2 months prior to surgery * patients with adenomyosis only * healthy non-endometriotic patients undergoing hysterectomy for infectious or malignant causes * patients benefiting from a legal protection measure (guardianship, curatorship, safeguard of justice) * patients with positive serology for human immunodeficiency virus (hiv), human t-lymphotropic virus (htlv), hepatitis b (hbv) and hepatitis c (hcv)

Keywords: stem cells organoid estrogen receptor erα immune cells single cell transcriptomic
robotic-assisted contra open resection for suspected or confirmed gallbladder cancer (robocop)

Conditions: Gall Bladder Cancer

Summary: the robocop trial is an international multi-centre, single blinded, randomized controlled superiority trial conducted in centres experienced in robotic-assisted liver surgery. eligible patients for radical cholecystectomy will be randomized in a 1:1 ratio to undergo robotic-assisted or open resection within an enhanced recovery setting. the primary endpoint is time to functional recovery. secondary endpoints include length of hospital stay, resection margin, number of retrieved lymph nodes, postoperative complications, quality of life, abdominal wall complaints and direct and indirect costs.

robotic-assisted surgery is hypothesised to reduce time to functional recovery by 2 days compared with open surgery. with a power of 80% and alpha of 0.05, the sample size needed in each arm to test superiority is 35 patients. with an expected 25% drop-out rate, 47 patients will be randomized in each group, with a total of 94 patients to be randomized in the trial.

Eligibility criteria:
inclusion criteria: * patient with radiologically suspected or confirmed (≥t1b) incidental gallbladder cancer after cholecystectomy with an indication of radical cholecystectomy, without the need for resection of extrahepatic bile ducts, as decided at a multidisciplinary team conference. * patient sufficiently fit to undergo radical cholecystectomy according to surgeon and anaesthesiologist. exclusion criteria: * previous extensive surgery in the upper abdomen (for example open liver surgery) * pregnancy * intraoperative findings of dissemination (patient is then excluded after randomization) * intraoperative findings of the need to perform resection of extrahepatic bile ducts (patient is then excluded after randomization). * intraoperative findings leading to a simple cholecystectomy only (patient is then excluded after randomization)
pre-operative antihypertension strategies-carotid artery stenting

Conditions: Carotid Stenosis

Summary: carotid artery stenting (cas) is one of major treatments in prevention of ischemic stroke. because of sinus reflex due to stenting and balloon dilatation, persistent post-surgery hypotension is a common perioperative event. persistent hypotension can lead to perioperative adverse events like ischemic stroke, myocardial infraction, renal failure and death; or more usually, it prolongs length of stay and hospital expenses. renin-angiotensin-aldosterone inhibitor (rasi) could inhibit the release of catecholamine and may lead to higher rate of persistent hypotension after cas compared to other hypertensives.thus, the investigators aim to investigate the effect of pre-operation antihypertensive drugs on persistent hypotension after stenting, and followed burden in carotid artery stenting comorbid with hypertension patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 * have a history of tia or nondisabling ischemic stroke within the past 6 months (symptomatic) with ipsilateral initial part of eica stenosis ≥ 50 % or asymptomatic with initial part of eica stenosis ≥ 70%, and the cause of stenosis was atherosclerosis * have hypertension requiring hypertensives * modified rankin scale (mrs) before stenting \< 3 exclusion criteria: * with ipsilateral tandem stenosis * with history of operation in contralateral carotid artery, like stenting, endarterectomy and bypass. * requiring operation in contralateral carotid artery in the same admission. * requiring general anesthesia in the same operation (stenting) * with contraindication to carotid stenting, such as inability to tolerate surgery due to organ dysfunction, cerebral aneurism, cerebral hemorrhage in 3 months, myocardial infraction or large-area cerebral infraction within 2 weeks, extreme tortuosity of the vessel * allergic to calcium channel blockers, angiotensin receptor blockers or hydrochlorothiazide * pregnancy * with concomitant medication as following: azole antifungals, macrolides antibiotics, cardiac calcium channel blockers, rifampicin, sildenafil, simvastatin, immunosuppressants, antidepressants, valproic acid, cimetidine, aliskiren, nsaids, protease inhibitors (ritonavir) and drugs that affect potassium in the blood * with hepatic insufficiency, renal insufficiency, kidney transplantation, diabetic nephropathy, biliary obstructive disease, or the presence of end-stage disease affecting clinical prognosis assessment (such as end-stage cancer, end-stage heart disease, liver failure, renal failure, pulmonary failure) * with depression, schizophrenia, bipolar disorder, epilepsy, tuberculosis, aids, primary hyperaldosteronism, hyperkalemia, hypercalcemia, hyperuricemia, gout * participating other trails which would affect the evaluation of outcomes * with reserpine and clonidine intake within 1 week

Keywords: carotid artery stenting sinus reflex antihypertensive drugs catecholamine
a clinical study to test long term safety of glpg1690 for patients with systemic sclerosis

Conditions: Systemic Sclerosis

Summary: this study was the extension of the double-blind study glpg1690-cl-204 (nct03798366). the main purpose of the study was to see how glpg1690 was tolerated in participants with systemic sclerosis and whether there were any side effects in a long-term treatment period.


Eligibility criteria:
inclusion criteria: * male or female participants who completed the 24-week treatment period of study glpg1690-cl-204 and who according to the investigator's judgment may benefit from long-term treatment with glpg1690. exclusion criteria: * any condition or circumstances that, in the opinion of the investigator, may make a participant unlikely or unable to complete the study or comply with study procedures and requirements.
exemestane as treatment in adjuvant for post-menopausal patients with non-metastatic breast cancer

Conditions: Breast Neoplasms

Summary: to compare recurrence free survival between two treatment groups (5 years with exemestane vs 2.5 to 3 years tamoxifen followed by 2 to 2.5 years of exemestane for a total duration of 5 years) this pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studies in 9 countries. this study is designed to be part of the larger team trial where the data from these 7 studies will be combined. a pre-specified analysis of the pooled data will be conducted. link to team trial \[971-onc-0028-081/a5991026\] study results: http://clinicaltrials.gov/ct2/show/results/nct00036270?term=971-onc-0028-081\&rank=1


Eligibility criteria:
inclusion criteria: * hr+ post-menopausal patients with non-metastatic breast cancer exclusion criteria: * any of the following: hr-, non-menopausal patient, metastatic breast cancer