Kornimate/medical-research-clean huggingface dataset:
the effect of low sodium diet on idiopathic hyperaldosteronism

Conditions: Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

Summary: this study was a single-center randomized controlled trial which lasted 14 days and consisted of two stages (run-in period (stage i) and intervention period (stage ii) each contain 7 days without potassium supplement. if participants meet the enrollment criteria at the end of stage i, they were assigned to the low sodium group (50mmol/d) or normal sodium group (100mmol/d), and then continued to finish stage ii. the primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet and the secondary outcome was the assessment of bp change following a normal sodium / low sodium diet. patients were given nifedipine controlled-release tablets 30 mg/d to lower blood pressure and were not provided any potassium supplements during the two stages. if the subject has an increase in bp (\>180/110 mmhg), the dose of nifedipine controlled-release tablets will be increased to 60 mg/d. patients will be withdrawn from the study if they cannot tolerate the diet or their serum potassium were below 2.8 mmol/l.


Eligibility criteria:
inclusion criteria: 1. 18-70 years; 2. diagnosed as pa by sit; 3. no lateralization of aldosterone secretion during avs; 4. serum potassium ≥ 2.8 mmol/l after the stage i. exclusion criteria: 1. impaired renal function (ccr\<60 ml/min); 2. impaired liver function (alt, ast \> 2.5 times upper limit of normal); 3. patients with heart failure (nyha≥ class 3 or ef \< 50%); 4. patients with stroke or acute infarction in the last 6 months; 5. patients who are pregnant or breastfeeding; 6. patients who cannot tolerate dietary arrangements; 7. patients with history of malignant tumors in the last 6 months.
the study to compare the cordis smart™ stent system with the bard® luminexx™ stent

Conditions: Arterial Occlusive Diseases

Summary: this study will look at the performance of the cordis s.m.a.r.t.™ control ™ nitinol stent system for the treatment of tasc c \& d superficial femoral artery long lesions (up to 22 cm) in comparison with the bard® luminexx™ 6f vascular stent as determined by the primary patency rate at 6 and 12 months post procedure.

this is a german multi-center prospective, randomized, two-arm study evaluating performance of the cordis s.m.a.r.t.™ control ™ nitinol stent system as compared to the c.r. bard® luminexx™ 6f vascular stent. patients will be randomized on a 1:1 basis. it is anticipated that a total of 200 patients will be entered into the study. the study population will consist of approximately 200 symptomatic peripheral vascular disease patients with tasc c \& d sfa lesions. the disease will consist of symptomatic, long de novo or restenotic lesions (\> 70% stenosis) and occlusions (5 - 22 cm) on diagnostic imaging. the lesion must not extend into the distal sfa and the popliteal artery. at least one distal popliteal artery must be patent as well as one calf vessel. reference vessel diameter must be \>= 4.0 to \<= 6.0 mm. trial participants will be randomized to the cordis s.m.a.r.t.™ control™ nitinol stent system or to the bard® luminexx™ 6f vascular stent. patients will be followed for twelve months post-procedure. study examinations will be done at screening, procedure time, discharge, six, and twelve months post procedure. this study will be conducted over up to 15 investigational sites in germany.

Eligibility criteria:
inclusion criteria: * symptomatic leg ischemia by rutherford classification (category 2, 3, 4 or 5); duration of intermittent claudication (category 2-3) should be at least 3 months. * one superficial femoral artery de novo or restenotic lesion (more than 70% stenosis or occlusions), with a lesion length of more than 5 to less than 22 cm. * patent popliteal artery on the index side, i.e., single vessel runoff or better with at least one of three vessels patent to the lower 1/3 of the calf prior to the day of the procedure. exclusion criteria: * revascularisation involving the same limb within 30 days prior to the index procedure or a planned revascularisation within 30 days after the index procedure. * patients having total occlusions of the iliac artery on the same side must be excluded. * previously implanted stent(s) in the to be treated artery at the same site. * requiring stent placement in the distal superficial femoral artery and the popliteal artery.

Keywords: peripheral artery occlusive disease
frozen embryo transfer pregnancy outcomes prediction by microbiome and transcriptome

Conditions: Infertility; Microbiome

Summary: this study intends to explore the correlation between cervical microbiome, gut microbiome, transcriptome and pregnancy outcomes of frozen embryo transfer patients through a multicenter prospective observational study, and to explore the predictive value of microbiome on pregnancy outcome.


Eligibility criteria:
inclusion criteria: 1. infertile women receiving assisted reproductive technology treatment, preparing for frozen embryo transfer cycle; 2. female age: 20-45 years old; 3. single frozen-thawed blastocyst transferred 4. endometrial thickness ≥7mm on the day of luteal transformation 5. written informed consent. exclusion criteria: 1. women who have pathologies or malformations that affect the pregnancy outcome:genital malformations, intrauterine adhesions, uterine fibroids (\>4 cm in diameter or compressing endometrial line), adenomyosis, endometrial polyps; untreated tubal pleura presence of autoimmune disease; 2. untreated hyperprolactinemia, thyroid disease, adrenal disease 3. antibiotic use within the past 7 days; 4. current or recent (within 3 months) drug abuse, including alcohol and tobacco; 5. refused or unable to comply with protocol requirements; 6. participation in any experimental drug study within 60 days prior to screening.
uft/lv maintenance vs observation in metastatic breast cancer responsive to chemotherapy

Conditions: Breast Cancer

Summary: to compare maintenance therapy to observation in metastatic breast cancer patients responding (or stabilized) after 1st-line chemotherapy. main endpoint is disease-free survival. secondary endpoints are overall survival and tolerance. a total of 200 patients will be included.


Eligibility criteria:
inclusion criteria: * metastatic breast cancer * objective response or stabilisation after 6 to 8 cycle of a first line chemotherapy * time period between the end of chemotherapy and randomization \< 4 weeks * age over 18 years * performance status (oms) \< 2. * life expectancy \> 3 months * biological criteria before randomization: neutrophiles \> 1.5 x 109 g/l; pl. \> 100 x 109 g/l; hb \> 10 g/dl; creatininemia \< 1,5 unl; bili. \< 2 unl; transaminases \< 2,5 unl; alcalines phosphatases \< 2,5 unl * signed written informed consent exclusion criteria: * metastatic breast cancer having received more than one chemotherapy line. * tumor progression under chemotherapy * free interval between primary tumor and metastases \> 5 years, with estrogen receptors and without visceral metastases * free interval between primary tumor and metastases \< 18 months after adjuvant chemotherapy if first lime chemotherapy only led to a tumor stabilization * concomitant hormonotherapy * other cancer * symptomatic brain metastases * any uncontrolled severe disease except breast cancer (especially cardiac failure with lvef \< 50% or coronary insufficiency * psychiatric disorder * other concomitant trial * male patient * pregnancy and breast-feeding (effective contraception is mandatory in the case of women of child-bearing potential) * history of high dose chemotherapy with bone marrow transplantation
low-frequency rotating magnetic system combined with systemic anti-tumor therapy for advanced lung cancer

Conditions: Lung Neoplasms

Summary: the purpose of this study is to determine whether low-frequency rotating magnetic therapy system is effective and safe in the treatment of advanced lung cancer.

the purpose of this study is to assess the efficacy and safety of the low-frequency rotating magnetic therapy system(with systemic anti-tumor therapy) compared to systemic anti-tumor therapy in patients suffering from advanced lung cancer.

Eligibility criteria:
inclusion criteria: * willing and able to give written informed consent * male or female aged 18 years and older * histologic diagnosis of non-small cell lung cancer (unable to receive surgery) or small cell lung cancer (limited stage or extensive stage) * eastern cooperative oncology group (ecog) performance status (ps) ≤ 3- going to receive systemic anti-tumor therapy * measurable disease based on recist 1.1 * adequate hematologic and organ function exclusion criteria: * currently participating and receiving study therapy in, or has participated in a study of an investigational agent and received study therapy or used an investigational device * unable to lie in bed * with any metal implants in body * human immunodeficiency virus (hiv) * malignancies other than lung cancer within 5 years prior to randomization * history or current evidence of any condition, therapy or laboratory abnormality that might confound the results of the trial or interfere with the subject's participation for the full duration of the trial * pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial

Keywords: lung cancer low-frequency rotating magnetic therapy system systemic anti-tumor therapy
an observational study of tarceva (erlotinib) in patients with non-small cell lung cancer

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this prospective, multi-center, observational study will assess the progression-free survival and safety of patients with locally advanced or metastatic non-small cell lung cancer treated with tarceva (erlotinib) and not disease progressing after at least 9 months. data will be collected for 24 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * diagnosis of locally advanced or metastatic non-small cell lung cancer (nsclc, stage iii/iv) * treatment with tarceva monotherapy and not progressing after at least 9 months at the date of study start exclusion criteria: * not agreeing to be followed-up (for a maximum of 24 months)
severe obesity outcome network cohort (soon)

Conditions: Obesity; Obstructive Sleep Apnea; Sleep

Summary: the main objective of the study is to identify the determinant of sleep characteristics of obese patients attempting a tertiary clinical center for obesity management, including bariatric surgery. more accurately the questions addressed are: * what are the determinants of the sleep habits (sleep duration, chronotype) and of their evolution * what are the determinants of sleep breathing disorders (sleep apnea, obesity hypoventilation syndrome) and of their evolution

adult obese patients, attempting a tertiary medical center for the management of their obesity, are asked to participate in a cohort study. data issued from routine clinical practice are collected. medical history and actual medical condition: * type 2 or type 1 diabetes * dyslipidemia * hypertension * cardiovascular diseases * steatohepatitis/cirrhosis * gastric disorders * nutritional deficiency * obstructive sleep apnea/obesity hypoventilation syndrome all patients who do not have a previously known sleep apnea syndrome are evaluated by nocturnal polygraphy. lifestyle and sleep habits, as well as social and economic characteristics, are assessed by questionnaires. patients are asked to provide blood sample to constituate a serum bank and gene bank. patients are asked, if undergoing bariatric surgery, to provide subcutaneous and visceral fat. when patients benefit from bariatric surgery, follow-up data are collected at 3 months, 6 months, 12 months after bariatric surgery and yearly after that for at least 5 years.

Eligibility criteria:
inclusion criteria: * class ii or class iii obesity (bmi ≥ 35 kg/m²). only patients undergoing surgery to realize a second surgical line of management of their obesity may have a lower bmi, if the surgical recovery is motivated by a technical defect of the first assembly. exclusion criteria: * refusal to participate.

Keywords: obesity obstructive sleep apnea sleep habits bariatric surgery cohort
outcomes of the intradural extramedullary tumors resection

Conditions: Spinal Cord Tumor

Summary: the intradural extramedullary tumors remain curable diseases. our aim in this study is to evaluate the postoperative status after the tumor resection and compare it to the preoperative status

meticulous microscopic excision without nerve root or dural injuries

Eligibility criteria:
inclusion criteria: * neurological deficit * back pain exclusion criteria: * old age above 80 years * immunocompromised patients
safety and effectiveness of the xen45 glaucoma treatment system in patients with angle closure glaucoma

Conditions: Glaucoma; Angle-Closure

Summary: this study will evaluate the safety and iop-lowering effectiveness of xen in patients with angle closure glaucoma.


Eligibility criteria:
inclusion criteria: inclusion criteria: - diagnosis of acg defined as areas of iridotrabecular contact present in ≥ 2 quadrants and glaucomatous damage to optic disc and visual field, in the study eye - study eye has healthy, free, and mobile conjunctiva in the target quadrant exclusion criteria: - uncontrolled systemic disease (eg, diabetes, hypertension) - known history of bleeding disorder or prolonged bleeding after surgery or those on pharmacologic blood thinners other than aspirin (up to 100 mg/day) - history of dermatologic keloid formation - open angle glaucoma, active acute angle closure attack, congenital glaucoma, juvenile glaucoma, secondary glaucoma in the study eye - history of following surgeries in the study eye: o incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions o corneal graft including partial grafts such as descemet's stripping endothelial keratoplasty and descemet's membrane endothelial keratoplasty o previous laser or incisional intraocular surgery that might interfere with the outcome of this trial - previous glaucoma shunt implantation in the target quadrant in the study eye - active or history of chronic uveitis in the study eye - unable to discontinue contact lens wear in the study eye during the study
biomarker research study for pf-03084014 in chemoresistant triple-negative breast cancer

Conditions: Breast Cancer

Summary: this is a phase ii open label biomarker research study off pf-03084014 in non-metastatic triple-negative breast cancer patients with residual disease (chemoresistant) after completion of standard neoadjuvant chemotherapy.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years old. 2. female. 3. histological diagnosis of triple-negative breast cancer (tnbc) breast adenocarcinoma (er\<1%, pr\<1% by (ihc) and her-2 0-1+ by ihc or ihc 2+ and fish or cish negative per updated asco guidelines). 4. no clinical or radiologic evidence of distant metastasis. 5. presence of residual primary disease of at least 1.5 cm by u/s or mri within 14 days preceding the last cycle of standard anthracycline and taxane-based neoadjuvant chemotherapy. patients with synchronous synchronous bilateral cancer and unilateral multifocal or multicentric or bilateral disease breast cancer will be allowed provided histologic diagnosis of tnbc is found on all performed biopsies. 6. completion of standard anthracycline and taxane-based neoadjuvant chemotherapy. the use of platinum agents in combination with standard neoadjuvant chemotherapy is allowed. 7. ecog performance status (ps) 0 or 1 8. adequate bone marrow function: absolute neutrophil count (anc) ≥ 1500/μl or ≥1.5 x 109/l; platelets ≥100000/μl or ≥100 x 109/l; hemoglobin ≥ 9 g/dl. 9. adequate renal function: serum creatinine ≤ 1.5 x upper limit of normal (uln) or estimated creatinine clearance ≥ 60 ml/min. 10. adequate liver function:total serum bilirubin ≤ 1.0 x uln or ≤ 2 x uln in cases of known gilberts syndrome; aspartate and alanine aminotransferase (ast and alt) ≤ 1.5 x uln; alkaline phosphatase ≤ 2.5 x uln. 11. for patients of childbearing potential: negative serum/urine pregnancy test and use accepted forms of non-hormonal contraception during the study period and up to 6 months after treatment completion. exclusion criteria: 1. concurrent anti-cancer therapy for current breast cancer (hormone therapy, chemotherapy, radiotherapy, immunotherapy). patients already included in another therapeutic trial involving an experimental drug. 2. pregnant or lactating women. 3. any prior history of invasive breast cancer. 4. any previous history of non-breast malignancies (excepted basal cell carcinoma or squamous cell carcinoma of the skin) in the preceding 5 years. 5. known hypersensitivity to the study drug or excipients. 6. patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study. 7. subjects unable to swallow oral medications.
blood and tears in alzheimer's disease

Conditions: Neurodegenerative Diseases

Summary: this study aims to investigate whether biomarkers of alzheimer's disease can be found in tearfluid, as well as dried bloodspots in patients with alzheimer's disease, other dementia diagnoses compared to controls.

participants under investigation of a neurodegenerative disease who have a planned lumbar puncture in the memory clinic will be invited to this study. on the same day of the lumbar puncture, tear fluid and dry blod spots will be collected. tear fluid is collected using shirmer's test. dried blood spots are obtained by a small prick in the finger with a lancet. the blood droplet is transferred onto a special piece of filter paper, where it dries. as a sub-study, participants who have provided written consent specifically for this purpose will repeat the test with dried blood spots at home one week after participating in the study. the samples are submitted to the memory clinic at the participant's next scheduled appointment. tear fluid, dried blood spots, as well as blood and cerebrospinal fluid will be examined for ad-related pathology.

Eligibility criteria:
inclusion criteria: inclusion criteria for patients: * lumbar puncture with csf avaiable for analysis * diagnosis of alzheimer's disease, dementia with lewy bodies (dlb), frontotemporal dementia (ftd), vascular dementia (vad) or normal pressure hydrocephalus (nph) * of legal age. inclusion criteria for controls: * lumbar puncture with csf avaiable for analysis * no neurological disease. * of legal age. exclusion criteria: * no lumbar puncture * clinically assessed as unfit to participate in the project.
pain and magnesium

Conditions: Neuropathic Pain Induced by Mastectomy

Summary: in breast cancer patients undergoing a mastectomy, the aim of this study is to evaluate if the magnesium administered for 6 weeks starting two weeks before the surgery induces a decrease of pain intensity one month post-mastectomy compared to the placebo group.

this is a randomized, placebo-controlled double-blind clinical trial conducted in the oncology hospital, clermont-ferrand, france, in 100 patients suffering from breast cancer and undergoing a total mastectomy. this clinical trial compares magnesium and placebo for the prevention of neuropathic pain induced by mastectomy assessed with a (0-10) numerical pain rating scale. cognition, anxiety, depression, sleep and quality of life are also assessed.

Eligibility criteria:
inclusion criteria: * - age ≥ 18 years, * patient with breast cancer who has a scheduled total mastectomy with or without treatment two weeks after inclusion with or without preoperative chemotherapy, * patient free from any new treatment or diet at the time of the inclusion, * cooperation and understanding sufficient to comply with the requirements of the study, * patients affiliated to the french social security, * patients with free and informed consent has been obtained exclusion criteria: * hypersensitivity to the active substance or to any of the excipients * patient with magnesemia \>1,05 mmol/l * patient with severe renal insufficiency with creatinine clearance \<30 ml min, * patient with an addiction to alcohol, as determined by the investigator, * diabetes (type i and ii), * medical and surgical history incompatible with the study, * patient receiving treatment with quinidine, l-dopa, * childbearing age, no use of effective contraceptive method, pregnancy or lactation * patient exclusion period, or the total allowable compensation exceeded * patients undergoing a measure of legal protection (guardianship, supervision ...)

Keywords: breast cancer mastectomy pain anxiety and depression cognition quality of life
study on the incidence of malignant neoplasms in patients with parkinson's disease and heterozygous mutation of the gba gene

Conditions: Idiopathic Parkinson&#39;s Disease (PD)

Summary: this multicenter retrospective observational study investigates the incidence of malignant neoplasms in parkinson's disease (pd) patients carrying heterozygous pathogenic variants in the gba1 gene. the study compares these patients to individuals with idiopathic pd and to the general population within a large national cohort. the rationale for the study lies in the growing evidence indicating an increased risk of malignant neoplasms in patients affected by gaucher disease. the primary objective is to assess whether pd patients with gba1 mutations have a higher incidence of malignant neoplasms compared to the general population. secondary objectives include comparing the incidence of malignant neoplasms between gba1-pd and idiopathic pd patients, as well as between idiopathic pd patients and the general population. additionally, the study aims to characterize oncological conditions by sex, age, center, and tumor site, with specific attention to distinguishing hematologic tumors from solid tumors. by identifying potential associations between gba1 mutations and malignancies in pd, the findings could guide more comprehensive patient management, including screening for malignant neoplasms alongside parkinson's disease care.

the study will involve a network composed by different italian movement disorders centres and the corresponding local cancer registries, responsible for the active collection of cancer cases. data will be collected from approximately 3000 consecutive parkinson's disease (pd) patients, including about 500 patients carrying gba1 mutations and 2500 idiopathic pd. data about the presence of malignancies will be extracted from the local cancer registries for each patient.

Eligibility criteria:
inclusion criteria: * \>18 years * diagnosis of parkinson's disease through the united kingdom parkinson's disease society brain bank diagnostic criteria for parkinson's disease. exclusion criteria: * uncertain diagnosis

Keywords: parkinson's disease neoplasms gba1 genetic parkinson's disease
characterization of subjective discomfort in patients with tear dysfunction

Conditions: Dry Eye Disease

Summary: characterization of subjective discomfort/pain in patients with ocular surface dysfunction in association with clinical and laboratory parameters, for a better understanding of the underlying pathogenic mechanisms.

dry eye disease (ded) is a multifactorial chronic disease impairing the ocular surface. ded can be associated with conditions of inflammation and neurosensory dysfunction. the aim of this study is to characterize the discomfort/pain in subjects affected by ded with the administration of scales, questionnaires, and analysis of corneal sensitivity by keratoesthesiometry, in association with clinical laboratory parameters.

Eligibility criteria:
inclusion criteria: * adult patients with suspected or diagnosed ded exclusion criteria: * nothing