Kornimate/medical-research-clean huggingface dataset:
interest of broadband spectroscopy analysis by infrared laser on liquid biopsies in breast cancer screening

Conditions: Breast Cancer Female; BRCA1 Mutation; BRCA2 Mutation

Summary: the purpose of this study is to validate the interest of broadband spectroscopy analysis (femto/attosecond by infrared laser) on liquid biopsies in breast cancer screening.

each patient will have one or more liquid biopsy during the follow-up according to the cohort and have a mammogram at the same time. biopsies will be analysed by broadband spectroscopy in order to compare the results to mammogram result.

Eligibility criteria:
inclusion criteria: \*for all participants : * adult woman capable of giving informed consent to research participation * affiliation to the french social security system \>for control cohort: * woman participating in organised screening or benefiting from individual follow-up, eligible as such for a mammogram \>for patient cohort: * woman with invasive breast cancer t0n1, t1n0-1, t2n0-1 (histologically proven) at inclusion and before any cancer treatment \>for exploratory cohort: * woman carrying the brca1/2 mutation, followed according to standard recommendations or * woman carrying the brca1/2 mutation suffering from in situ bc discovered on biopsy and histologically confirmed exclusion criteria: * for all participants : * refusal to participate * reluctant or unable to comply with study requirements * pregnant or breastfeeding woman * history of breast cancer * for patient cohort - patients with stage iii/iv or bilateral breast cancer * for control cohort: * invasive breast cancer suspected at mammography before liquid biopsy\* * mammography classified acr3 or acr4 * for exploratory cohort: * concomitant breast cancer * at inclusion visit, woman for whom an invasive breast cancer will be suspected at mammography will be include in patient cohort after an histological proof of cancer

Keywords: breast cancer broadband spectroscopy laser liquid biospsies cancer screening
a study of the combination of osimertinib, platinum and etoposide for patients with metastatic egfr mutant lung cancers

Conditions: Lung Cancer

Summary: the purpose of this study is to test the safety of combining osimertinib with either cisplatin or carboplatin (at different dose levels) and etoposide, to find out what effects, if any, this combination of drugs has on people with egfr mutant lung cancer.


Eligibility criteria:
inclusion criteria: * written informed consent * advanced biopsy-proven metastatic non-small cell lung cancer * either have not started an egfr tki or may have started osimertinib within the last 9 weeks * somatic activating mutation in egfr in pre-treatment tumor biopsy or cfdna * evidence of a concurrent p53 alteration by ihc or ngs on pre-treatment tumor biopsy or cfdna * evidence of a concurrent rb1 alteration by ihc or ngs on pre-treatment tumor biopsy or cfdna * must have a site of disease amenable to repeat biopsy and be willing to undergo a biopsy during treatment * measurable (recist 1.1) indicator lesion not previously irradiated * karnofsky performance status (kps) ≥ 70% * age \>18 years old * ability to swallow oral medication * adequate organ function * ast, alt ≤ 3 x uln * total bilirubin ≤ 1.5x uln * creatinine ≤ 1.5x uln or calculated creatinine clearance ≥ 60ml/min * absolute neutrophil count (anc) ≥ 1000 cells/mm\^3 * hemoglobin≥8.0 g/dl * platelets ≥100,000/mm\^3 exclusion criteria: * pregnant or lactating women * started an egfr tki other than osimertinib or started osimertinib more than 9 weeks ago * any radiotherapy within 1 week of starting treatment on protocol. * any major surgery within 1 weeks of starting treatment on protocol. * any evidence of active clinically significant interstitial lung disease * continue to have unresolved \> grade 1 toxicity from any previous treatment * have pure small cell histology * corrected qt interval using fridericia's formula (qtcf)\>475msec or any clinically significant (as deemed by the investigator) abnormalities in rhythm or conduction or morphology of the resting ekg. * patients are to be excluded from cisplatin treatment arm if they meet any of the following criteria: * creatinine clearance \< 60 ml/min * hearing impairment requiring assistive device * neuropathy * the treating provider does not feel as though the patient should receive cisplatin

Keywords: osimertinib platinum etoposide egfr mutant 18-211
hypofractionated radiotherapy concomitantly with weekly boost for breast cancer patients treated with conservative breast surgery

Conditions: Breast Cancer

Summary: this is a retrospective study on evaluation of the efficacy and the safety of a hypofractionated radiotherapy course with weekly concomitant boost for breast cancer patients treated with conservative breast surgery .


Eligibility criteria:
inclusion criteria: 1. women aged from 18 and up to 55 years old. 2. histologically diagnosed with breast carcinoma (ductal and others ) 3. all patients with conservative breast surgery. 4. including all patients with in all stages except those stage iv. 5. all patients with clear free surgical margin. 6. patients received hypofractionated radiotherapy with weekly concomitant boost exclusion criteria: 1. evidence of distant metastatic deposites. 2. patients with mastectomy 3. patients with prior irradiation to thoracic region. 4. pregnancy or lactation.
early transcatheter mitral valve repair after myocardial infarction

Conditions: Acute Mitral Regurgitation

Summary: to explore the impact of early transcatheter edge-to-edge repair of acute functional mitral regurgitation after myocardial infarction on the combined incidence of death and heart-failure associated hospitalisations at one-year follow-up, and quality of life and lv remodelling at two-year follow-up.

prospective, multicentre, randomised, open-label, comparative effectiveness clinical trial for the treatment of clinically significant functional mitral regurgitation within 60 days after acute myocardial infarction, who are treated per standard of care and who have been determined by the site's local heart team as inappropriate or too high risk for mitral valve surgery. eligible subjects will be randomized in a 1:1 ratio to the mitraclip device (intervention group) or to no mitraclip device (control group).

Eligibility criteria:
inclusion criteria: * patients with symptomatic moderate to severe or severe mr after acute mi * age \> 18 years * based on the following classification recently published in "transcatheter mitral edge-to-edge repair for treatment of acute mitral regurgitation" by m. shuvy et al. (can j cardiol. 2023) patients will be included if categorized in type 2, 3 or 4: exclusion criteria: * primary mr (e.g. papillary muscle rupture) * ef ≤ 25% * accepted for cabg * presence of cardiogenic shock (amr type 1)

Keywords: mitraclip
long term daily use of jardiance® tablets in japanese patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: study to investigate the safety and efficacy of long-term daily use of jardiance® tablets in japanese patients with type 2 diabetes mellitus


Eligibility criteria:
inclusion criteria: male and female japanese patients with type 2 diabetes mellitus who have never been treated with jardiance® tablets before the enrolment exclusion criteria: none
a non-interventional prospective study of 1-st line treatment approaches in ovarian cancer patients with hrd+ status in russian federation

Conditions: Ovarian Cancer

Summary: study population will consist of hrd+ (brcam +/- positive genomic instability score according to used test system) oc with available medical history. it is estimated that approximately 400 patients will be enrolled in approximately 25 sites. demographic and clinical characteristics, treatment approaches and outcomes in hrd+ patients with high-grade epithelial ovarian, primary peritoneal, and/or fallopian tube cancer will be collected at baseline and on prospective visits.


Eligibility criteria:
inclusion criteria: * patients ≥18 years of age; * willing and ability to provide written informed consent for participation in the study; * known status hrd+ (positive brcam test and/or positive genomic instability test); * patients with histologically confirmed diagnosis of high-grade ic-iv figo stages epithelial ovarian, primary peritoneal, and/or fallopian tube cancer; * completed primary treatment (surgery and/or 1st line ct +/- bevacizumab) no more than 3 months after completion of primary treatment. exclusion criteria: * patients participating in other clinical studies
study of vitamin d in the severely mentally ill

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: supplementation of vitamin d in those with low levels will increase the level and result in some improvement in health and psychopathology measures.

subjects with levels of vitamin d between 7ng/ml and 30ng/ml will, after signing consent forms, be randomly assigned to either start immediately on vitamin d for three months or to start after a delay of three months. those with levels below 7gn/ml will start immediately. all will be evaluated monthly with blood tests, panss, movement disorder ratings and information on health and progress from the clinical chart.

Eligibility criteria:
inclusion criteria: * age 19-70, * schizophrenia or schizoaffective disorder * stabilized but not expecting to be discharged soon * capacity to give informed consent exclusion criteria: * acutely psychotic * acutely medically ill * renal insufficiency * hypercalcemia * hyperparathyroidism

Keywords: vitamin d schizophrenia severely mentally ill
wire instrumentation using radiofrequency energy to impact transseptal efficiency

Conditions: Atrial Fibrillation; Atrial Flutter

Summary: this is a randomized controlled trial examining whether baylis's versacross rf wire versus the conventional baylis rf needle is better at puncturing through a thin wall in the heart (called "transseptal puncture") as measured by time to successful transseptal puncture, during cardiac ablation procedures.

the transseptal puncture is one of the most commonly performed procedures in the cardiac electrophysiology and interventional cardiology laboratories. indeed, every atrial fibrillation ablation, now the predominant electrophysiology procedure performed throughout the world, routinely involves two different transseptal puncture procedures. the investigators previously performed a randomized, comparative effectiveness trial demonstrating the superiority (in both efficacy and safety) of a radiofrequency (rf) transseptal needle versus the conventional sharp-tipped mechanical needle. more recently, an alternative approach to transseptal puncture has been fda approved and is already utilized as part of standard of care in these procedures. with this new approach, a j-shaped wire that can transmit rf energy is advanced inside the transeptal sheath rather than the more stiff rf or conventional needle. as advancing a wire is usually a step employed in any transseptal procedure (then usually requiring removal of that wire and then placement of the needle), this new approach saves a step. in addition once the wire has been advanced across the intra-atrial septum into the left atrium, the wire can be used to avoid potentially severe complications; specifically, after a transseptal needle is advanced across the left atrium, advancing the sheath over the needle can result in a sudden jump of all the equipment, risking perforation of the far left atrial wall. with the wire approach, the wire can be safely advanced into a pulmonary vein so that even if the sheath and dilator jump suddenly across the septum, they will be guided along the wire and thereby avoid perforation. the investigators will be studying patients undergoing a catheter ablation procedure at university of california, san francisco.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * patients undergoing endocardial left atrial catheter ablation procedures using radiofrequency ablation catheters for atrial fibrillation or atrial flutter ablation procedures at ucsf * willing and able to provide written informed consent in english * willing and able to comply with scheduled remote follow-up visits through 1 year post-operative exclusion criteria: * presence of a patent foramen ovale closure device or atrial septal defect closure device * cryoballoon ablation * ivc filter * deemed not suitable by study personnel
evaluation of supraclavicular, suprascapular, and interscalene nerve blocks for outpatient shoulder surgery

Conditions: Pain, Postoperative; Pain; Shoulder Joint; Pathologic Processes

Summary: the aim of this study is to assess analgesic efficacy of a supraclavicular nerve block, suprascapular nerve block, or interscalene nerve block in a population undergoing shoulder arthroscopy with rotator cuff repair. the investigators hypothesize that subjects from all three arms will receive equal analgesia since these blocks are routinely performed to treat post-operative pain after shoulder surgery.


Eligibility criteria:
inclusion criteria: * unilateral total shoulder arthroscopy for rotator cuff surgery asa physical status i-iii, \>18 years old, non-pregnant, consent to participate in the study exclusion criteria: * refusal to participate, \< 18 years old, chronic opioid use, localized infection, pregnancy or lactating, pre-existing coagulopathy, allergy to ultrasound gel or local anesthetics, diaphragmatic dysfunction
standard clopidogrel versus prasugrel low dose therapy in elderly patients with acute coronary syndrome

Conditions: Coronary Artery Disease

Summary: the elderly represent a growing segment of the coronary population treated by dual antiplatelet therapy for percutaneous coronary intervention (pci). these patients bear a higher risk of both ischemic events and bleeding complications than younger patients, with a subsequently higher rate of mortality.recentprogress in antithrombotic treatment demonstrated the efficacy of adding a p2y12 receptor antagonist to low-dose aspirin. whether this benefit is also present in the elderly remains a debated issue due to the lack of specific data in this sub-population. the present study was realized to provide specific data on platelet response to clopidogrel, standard dose (75 mg) or prasugrel 5 mg in elderly patients (≥75 years old) whereas the superiority in pr response of the latter should allows the prasugrel therapy in elderly patients with the better clinical efficacy and therapeutical safety already showed compared with clopidogrel.


Eligibility criteria:
inclusion criteria: * acute coronary syndrome * pci with stent implantation * clopidogrel responsiveness * \> 75 years of age. exclusion criteria: * history of bleeding diathesis * chronic oral anticoagulation treatment * contraindications to antiplatelet therapy * pci or coronary artery bypass grafting (cabg) \< 3 months * hemodynamic instability * platelet count \< 100,000/μl * hematocrit \< 30% * creatinine clearance \< 25 ml/min * patients with a history of stroke * other contraindication for prasugrel administration * patients weighing \< 60 kg * high on treatment platelet reactivity

Keywords: antiplatelet effect prasugrel clopidogrel acute coronary syndrome
efficacy of combined oral l-ornithine-l-aspartate and lactulose in patients with hepatic encephalopathy

Conditions: Hepatic Encephalopathy

Summary: hypothesis: is the combination of oral l-ornithine-l-aspartate and lactulose more efficacious than oral lactulose alone in treatment of hepatic encephalopathy? study design; randomized, double-blinded, placebo controlled trial

data collection 1. baseline characteristics * demographic data; age, gender, bw, height * cirrhosis; cause, duration, child-pugh score,complications of cirrhosis such as ev, ascites, hepatic encephalopathy, sbp etc. * comorbidity such as dm, cva 2. after randomization * assessment of mental status (west-haven criteria), portal-systemic encephalopathy index (psei), number connection test, serum ammonia, asterixis at day 1,3,7 and eeg at day 1,7 * blood chemistry such as cbc, bun, creatinine, electrolyte, lft, coagulogram, bs at day 1,3,7 * record adverse effect of drug such as nausea, vomiting, bloating. * record diet, frequency of bowel movement and stool ph * compliance

Eligibility criteria:
inclusion criteria: * cirrhosis * age 18-80 * hepatic encephalopathy grade ii-iii * serum ammonia \> 60 mcg/ml * informed consent exclusion criteria: * recent gi hemorrhage * severe sepsis * degenerative cns disease or major psychiatric illness * serum creatinine \> 1.5 mg/dl * pregnancy or lactation * poorly controlled dm * insertion of tips * received cns depressants or hypnotics * treatment with metronidazole, kanamycin or branched-chain amino acid * hypersensitivity to l-ornithine-l-aspartate

Keywords: l ornithine l aspartate lactulose hepatic encephalopathy lola
the role of central sensitization on biopsychosocial factors in primary sjögren's syndrome

Conditions: Sjogren's Syndrome

Summary: following the guidance of individuals with primary sjögren's syndrome who receive diagnosis, routine medical care, and treatment management, the evaluations will be performed once by the researchers and will take approximately one hour. in addition, healthy individuals with a similar average age to the evaluation group without any disease diagnosis will be included in the study as a control group. evaluations of the healthy group will be made once by the researchers and will take approximately one hour. data will be collected face to face at the faculty of physical therapy and rehabilitation, rheumatology unit. data collection tool of the research: * information about patients will be recorded with the demographic information form. * eular sjögren's syndrome disease activity index * eular sjögren's syndrome patient reporting index * primary sjögren's syndrome quality of life scale * bety-biopsychosocial questionnaire * central sensitization scale * pain catastrophizing scale * hospital anxiety and depression scale * multidimensional fatigue rating scale * turkish eating assessment tool * yale swallow protocol * test of mastication and swallowing solids * dysphagia limit test * xerostomia inventory


Eligibility criteria:
inclusion criteria: * patients diagnosed with primary sjögren's syndrome * 18 years or older exclusion criteria: * patients with secondary sjögren's syndrome, * patients who are diagnosed with other uncontrolled/clinically important diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.), * having a malignant condition, * pregnant individuals in the third trimester, * individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.

Keywords: sjogren' syndrome correlation xerostomia dryness
comparison of between thinseed™ and oncoseed™ for permanent prostate brachytherapy

Conditions: Prostate Cancer

Summary: this study will investigate health related quality of life factors in patients undergoing low dose rate prostate brachytherapy. patients will be randomized to iodine-125 thinstrand (for use with 20 g needles) or rapidstrand (for use with standard 18 g needles). urinary, bowel, sexual function and bother will be measured by the epic questionnaire at various time intervals.


Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate, clinical stage t1c - t2b, n0, m0 * greater than or equal to 40 years of age * low and low- intermediate risk prostate cancer * prostate volumes by trus ≤ 60 cc * i-pss score \< 25 (alpha blockers allowed) * signed study-specific informed consent form prior to study entry exclusion criteria: * lymph node involvement (n1) * evidence of distant metastases (m1) * radical surgery for carcinoma of the prostate * prior pelvic radiation * major medical or psychiatric illness, which in the investigator's opinion would prevent completion of treatment and would interfere with follow- up or ability to complete questionnaires * hip prosthesis * inability or refusal to provide informed consent * evidence of previous turp * prior hormone therapy * prior turp

Keywords: prostate cancer prostate brachytherapy
in-practice evaluation of atacand 16mg antihypertensive effect

Conditions: Essential Hypertension

Summary: the purpose of this study is to prove in practice the effectiveness of atacand 16 mg in reducing blood pressure after 4 weeks of administration and the importance of administration of adequate doses


Eligibility criteria:
inclusion criteria: * adult patients with mild (140-159/90-99 mghg) to moderate (160-179/100-109 mmhg) essential hypertension, already treated with atacand 8mg for 2-4 weeks, who have not reached the blood pressure treatment goal at least \<140/90 mghg and the doctor has decided * signed and dated patient informed consent (icf) exclusion criteria: * hypersensitivity to the active substance or to any of the excipients of atacand.

Keywords: hypertension blood pressure atacand
nocardia cell wall skeleton for the treatment of diabetic foot ulcer wounds

Conditions: Diabetic Foot Ulcer; Therapy, Directly Observed

Summary: this study was to investigate the efficacy and safety of nocardia rubra cell wall skeleton (ncws) in the treatment of diabetic foot ulcer wounds. the study was a prospective, randomized, controlled, multicentre study . the subjects were randomly divided into two groups: ncws group and control group（silver ions dressing）, with a total of 116 cases and 58 cases in each group. patients in the ncws group received nocardia rubra cell wall skeleton for external use, in parallel with silver ions dressing treatment. the efficacy and side effects were observed, with a primary endpoint of 30-days wound healing rate.


Eligibility criteria:
inclusion criteria: * ages 18 to 80 years old (including 18 and 80 years of age), gender not limited; * in patients with type 2 diabetic foot, in 1999 the who diagnostic criteria, diabetic foot screening period or three months before randomization glycated hemoglobin (hba1c) was detected in 10% or less; * the target body ankle brachial index of at least 0.8, without intermittent claudication walkers; * the target ulcer must have the following characteristics: a) according to the wagner ulcer classification system for level 1 or level 2 b) ulcer is located in the foot, ankle and shin before; c) wound area of 2-5 cm2; d) has existed at least 4 weeks before randomization; e) if you have multiple wounds, select into the set standard and area is one of the biggest intervention and evaluation of the wound.the rest of the wound conventional treatment is not included in the study;if there are two or more wounds are the biggest, choose the worst into classification research;if there are two or more wound area and the classification, choice wound area are the longest study; f) without visible pus and necrotic material; * voluntary to participate in this clinical study, cooperate a doctor to conduct research, and sign the informed consent. exclusion criteria: * with clear surgical indications, such as vascular occlusion, bone exposed, abscess, osteomyelitis, etc; * into the group of the first 3 months of vascular reconstruction or angioplasty; * impaired liver function (alt and ast 3 times more than normal limit, ast, aspartate amino transferase;alt: alanine aminotransferase); * serum creatinine greater than 2 times the upper limit of normal value; * serum albumin \< 2.0 g/dl; * is undergoing immunosuppressive medication; * various malignant tumor patients ; * of pregnant women, nursing mothers, or in the near future with family planning; ● with nerve, mental disorders and can't cooperation or unwilling to partners, has a history of alcoholism, drug abuse, and failed to quit; * into the group of the first 3 months participated in other clinical subjects; cartesian bacteria cell wall * to use red, skeleton or silver products are taboo, allergies or known allergies; * researchers believe that patients should not participate in this study to other situations.

Keywords: diabetic foot ulcer nocardia rubra cell wall skeleton