Kornimate/medical-research-clean huggingface dataset:
study of ductal lavage in women at high risk for breast cancer

Conditions: Breast Cancer

Summary: rationale: collecting samples of fluid using ductal lavage and nipple aspiration from participants at high risk for breast cancer to study in the laboratory may help doctors learn more about changes that may occur in dna and identify biomarkers related to cancer. purpose: this clinical trial is using ductal lavage to collect fluid from women at high risk for breast cancer.

objectives: primary * determine the volume of atypical cells collected from ductal lavage in women at increased risk for breast cancer. secondary * determine assay techniques to analyze nipple aspirate fluid and ductal lavage fluid samples from these participants. * analyze the nipple aspirate fluid from these participants for specific and global protein signatures. * determine the replicability of markers in serial assays of these participants. * determine the percentage of participants with atypia on ductal lavage in which ductal lesions can be identified using ductoscopy. outline: this is a multicenter study. participants undergo nipple aspirate fluid and ductal lavage fluid collection. fluid samples are analyzed using cytological analysis, immunohistochemistry, fluorescent in situ hybridization, or in situ polymerase chain reaction. protein patterns are identified using mass spectrometry. participants found to have atypia undergo repeat lavage at 3-6 months and 1 year. participants with normal fluid samples undergo repeat lavage at 1 year. projected accrual: a total of 30 participants will accrued for this study within 2-3 months.

Eligibility criteria:
disease characteristics: * high risk for breast cancer defined as 1 of the following: * history of atypical hyperplasia or atypia found on biopsy, fine-needle aspiration, or ductal lavage * family history of cancer meeting at least 1 of the following criteria: * single relative with multiple primary cancers * one or more relative under 40 years of age with breast cancer or bilateral breast cancer * two or more relatives with ovarian cancer * two or more relatives with breast cancer and 1 is under 50 years of age * one or more relative with breast cancer plus ≥ 1 relative with ovarian cancer * ashkenazi jewish descent and relative with breast cancer under 50 years of age or ovarian cancer at any age * brca1 and/or brca2 mutation * prior breast cancer in contralateral breast * gail risk \> 1.7% * spontaneous nipple discharge * serum estradiol \> 10 pmol/l * hormone receptor status: * not specified patient characteristics: age * over 18 sex * female menopausal status * not specified performance status * not specified life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified other * able to obtain breast duct fluids prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * more than 4 months since prior tamoxifen or raloxifene radiotherapy * no prior radiotherapy to the breast surgery * no prior incisional or excisional biopsy within 1.5 cm of nipple other * no prior neoadjuvant therapy

Keywords: breast cancer
a study to assess sorafenib alone and in combination with low-dose interferon following unsuccessful treatment with sunitinib in patients with advanced renal cell cancer.

Conditions: Carcinoma, Renal Cell

Summary: this study is to assess sorafenib as second treatment for patients that have previously received only sunitinib as first-line treatment for advanced renal cell cancer, and who either responded and then progressed with sunitinib or were intolerant to sunitinib. this study is to assess if combining the usual dose of sorafenib (200mg twice-daily) with low dose interferon (3 million international unit (miu) five times a week) can treat kidney cancer more effectively than the current approved dose alone and if it is safe. in addition, for patients that respond to treatment with sorafenib alone or in combination with interferon before progressing, patients may receive sorafenib alone at an increased dose of 300mg twice-daily, provided that toxicities are acceptable and at the discretion of the investigator.


Eligibility criteria:
inclusion criteria: * disease progression as defined by response evaluation criteria in solid tumors (recist) criteria following documented stable disease or better after at least 8 weeks of sunitinib as first-line treatment (or two cycles of 4 weeks on and 2 weeks off treatment) * and/or patients who have discontinued sunitinib treatment at any point due to toxicity * study entry at least 2 weeks after treatment with sunitinib but up to a maximum of 8 weeks * memorial sloane kettering cancer centre (mskcc) prognostic score low or intermediate * eastern cooperative oncology group (ecog) performance status of 0 or 1 * patient must have histologically confirmed metastatic renal cell carcinoma with predominant clear cell histology (clear cell component more than 50%). exclusion criteria: * patient should be excluded if they have unresolved chronic toxicity grade * \> 1 and related to prior therapy with sunitinib.

Keywords: renal cell cancer interferon
a study conducted to evaluate the conjunctiva and tenon's capsule status of healthy subjects and in participants with neovascular age-related macular degeneration (namd)/diabetic macular edema (dme)

Conditions: Neovascular Age-related Macular Degeneration; Diabetic Macular Edema

Summary: the purpose of this study is to obtain conjunctiva and tenon's capsule thickness measurements in vivo using spectral domain-optical coherence tomography (sd-oct) in participants with namd/dme and age-matched healthy subjects.


Eligibility criteria:
inclusion criteria: for namd/dme participants: - diagnosis of namd/dme for healthy subjects: - normal visual function exclusion criteria: * current or past treatment for glaucoma (only for healthy subjects) * dry eye disease except those treated only with artificial tears * ocular hypertension treated with hypotensive drugs * pterygium * strabismus * previous ocular surgery except cataract surgery * cataract surgery with scleral incision * current contact lens wearers * myopia with more than 6 diopters * corneal transplant * history of ocular surface inflammation * active or recent conjunctivitis infection * pregnancy * participant who has already received an ivt injection in the superotemporal quadrant (only for namd/dme participants)
virtual reality combined with rtms for the treatment of depression : a randomized clinical trial.

Conditions: the Treatment of Depression

Summary: depression is a mood disorder affecting an individual in its entirety, altering its emotional and intellectual functioning . the major form of depression is the most common psychiatric disorder in western countries. it is considered to be the most expensive psychiatric neurological disease in europe and is currently treated by different methods. however, almost a third of depressed patients shows no clinical improvement. advances in neuroscience and understanding of neuromodulation have enabled the emergence of new treatments such as the repetitive transcranial magnetic stimulation (rtms) . it consists of modulating the neuronal activity of a targeted brain region through a magnetic field applied by a coil. even though this form of treatment has proven to be effective, it appears that more than half of depressed patients exhibited little to no response to it. as brain regions targeted by tms may also be stimulated beforehand by sensory afferent signals, it was hypothesized that optimizing the effects of tms with virtual reality is possible through the activation of these brain regions with sensory stimuli holding emotional valence (images, sounds) while using tms concomitantly. based on this new research premise, the investigators propose, in the context of an open and controlled clinical trial, to use a new media entitled virtual reality for displaying interactive virtual environments with positive emotional valence ( field of flowers, green valley) to a group of depressed patients undergoing tms at the same time. the study will include 66 depressed patients randomly assigned into two groups : tms and virtual reality versus tms alone. any differences in therapeutic efficacy between the two groups will be measured by questionnaires and brain functional imagery. this innovative and therapeutic approach will allow us to better understand the appropriate processes for modulating the neuronal activity in specific brain areas for treatment purposes.


Eligibility criteria:
inclusion criteria: * criteria of resistant depression * age from 18 to 65 years old included. * primary diagnosis of major depression in subjects according to the diagnostic and statistical manual of mental disorders (dsm-5) criteria. * informed consent and signed to participate in the study exclusion criteria: * pregnant woman, parturient and nursing mothers. * absence of dsm-5 criteria for depression in subjects. * refusal to participate in the study. * modification of drug treatment in the month preceding inclusion. * history of neurological pathology, head trauma or mental retardation. * presence of an addictive comorbidity. * presence of a major organic pathological. * presence of a contra-indication to virtual reality * presence of intracerebral ferro-metallic material, cochlear implant, pacemaker
c1 esterase inhibitor (c1inh-nf) for the prevention of acute hereditary angioedema (hae) attacks

Conditions: Hereditary Angioedema

Summary: the study objective was to determine the safety and efficacy of c1inh-nf for the prevention of acute hae attacks.

subjects were given diary cards and instructed to document all hae attacks on a daily basis. subjects evaluated their symptoms over the previous 24 hours, noting the severity and duration of swelling at each of 5 locations (abdominal, genitourinary, facial, respiratory \[including laryngeal\], and/or extremity). the study design also allowed for administration of open-label c1inh-nf (1,000 u of c1inh-nf administered iv \[repeated after 60 minutes, if necessary\] for treatment of laryngeal angioedema or if deemed necessary by the investigator; 1,000 u of c1inh-nf administered iv \[single dose\] prior to emergency surgical procedures). a total of 26 subjects were enrolled in the study. one subject received open-label c1inh-nf but withdrew prior to randomization. another subject was randomized but withdrew prior to receiving study drug. twenty-four (24) subjects were randomized and treated with blinded study drug. in total, 25 subjects received at least 1 dose of study drug and were analyzed for safety; all 25 subjects were exposed to c1inh-nf and 23 subjects were exposed to placebo.

Eligibility criteria:
inclusion criteria: * documented hae * normal c1q level * relatively frequent angioedema attacks (at least 2 per month on average) exclusion criteria: * low c1q level * b-cell malignancy * presence of anti-c1inh autoantibody * history of allergic reaction to c1inh or other blood products * narcotic addiction * current participation in any other investigational drug study or within the past 30 days * participation in a c1 esterase inhibitor trial, or received blood or a blood product in the past 90 days * pregnancy or lactation * any clinically significant medical condition, such as renal failure, that in the opinion of the investigator would interfere with the subject's ability to participate in the study

Keywords: hereditary angioedema hae c1 esterase inhibitor (human) c1inh-nf
study of peri-operative docetaxel plus laparoscopic radical prostatectomy in prostate cancer patients

Conditions: Prostate Cancer

Summary: this is a prospective phase ii study of peri-operative docetaxel plus laparoscopic radical prostatectomy in patients with localized gleason 7 pt2a-pt2b adenocarcinoma of the prostate and a risk of relapse after radical prostatectomy.


Eligibility criteria:
inclusion criteria: * patients older than 18 years and less than 70 years * histologically-proven gleason 7 adenocarcinoma of the prostate * pt2a or pt2b disease based on biopsies of the prostate * more than 2/3 of positive biopsies or 15 ≤ serum psa \<20 * no previous carcinoma, except basal-cell carcinoma of the skin * adequate renal function: measured or calculated creatinine clearance\> 60 ml/min * absolute granulocyte count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5 fold the upper normal value * signed informed consent. exclusion criteria: * patients infected by the human immunodeficiency virus (hiv) * contra-indication to general anesthesia or surgery * patients who do not fit inclusion criteria

Keywords: patients with localized gleason 7 pt2a-pt2b adenocarcinoma of the prostate
a prospective cohort study comparing ai prediction model with imaging assessment to diagnose lymph node metastasis in cervical cancer

Conditions: Uterine Cervical Neoplasms

Summary: the goal of this prospective cohort study is to learn whether artificial intelligence multimodal fusion prediction models are effective in diagnosing pelvic lymph node metastasis in cervical cancer. the main question it aims to answer is: can artificial intelligence multimodal fusion prediction models improve the accuracy of preoperative diagnosis of pelvic lymph node metastasis in cervical cancer? the researchers compared the ai multimodal fusion prediction model with traditional imaging physician assessments to see if the prediction model could yield more accurate lymph node metastasis determinations. participants will undergo pelvic mri after pathologically confirming a diagnosis of cervical cancer, and the results will be used to determine pelvic lymph node metastasis status by the predictive model and the imaging physician, respectively. subsequent pathology results after surgical lymph node clearance will be used as the gold standard to determine the accuracy of the two preoperative lymph node diagnostic modalities.


Eligibility criteria:
inclusion criteria: 1. patients with preoperative diagnosis of invasive cervical cancer stage i-iii, with any type of pathology, and patients who underwent radical/modified radical cervical cancer surgery + pelvic lymph node dissection in our hospital or sub-center; 2. age ≥18 years and ≤80 years; 3. patients who underwent preoperative pelvic mri (plain/enhanced) imaging in our hospital or sub-centers. exclusion criteria: 1. patients during pregnancy or lactation, patients with abortion within 42 days; 2. patients who are undergoing or have undergone preoperative neoadjuvant chemotherapy or radiotherapy for this cervical cancer; 3. patients with other malignant tumors within 5 years; 4. combination of other underlying diseases that may lead to enlarged pelvic lymph nodes; 5. patients whose preoperative pelvic mri date is more than 1 month from the day of surgery; 6. poor quality imaging images that are unrecognizable.
study of platelet function after administration of aspirin versus lysine acetylsalicylate in stemi patients

Conditions: Acute Myocardial Infarction

Summary: prasugrel and ticagrelor, new p2y12-adp receptor antagonists, are associated with greater pharmacodynamic inhibition and reduction of cardiovascular events in patients with an acute coronary syndrome. however, evidence is lacked about the effects of achieving faster and stronger cyclooxygenase inhibition with intravenous lysine acetylsalicylate (la) compared to oral aspirin on prasugrel inhibited platelets. recently, we demonstrated in healthy volunteers that the administration of intravenous la resulted in a significantly reduction of platelet reactivity compared to oral aspirin on prasugrel inhibited platelets. loading dose of la achieves platelet inhibition faster, greater and with less variability than aspirin. however, there are no data of this issue in patients with an st-segment elevation myocardial infarction (stemi). the ecclipse-stemi trial will study the effect of la versus aspirin in platelet reactivity in patients with stemi

this is a prospective, randomized, single-center, open platelet function study conducted in 60 stemi patients. subjects were randomly assigned to receive a loading dose (ld) of intravenous la 450mg plus oral prasugrel 60mg/ticagrelor 180mg, or ld of aspirin 300mg plus prasugrel 60mg/ticagrelor 180mg orally. platelet function was evaluated at baseline, 30 min, 1h, 4h, and 24h using multiple electrode aggregometry and vasodilator-stimulated phosphoprotein phosphorylation (vasp). the primary endpoint of the study is the inhibition of platelet aggregation after arachidonic acid (aa) 1.5mm at 30 min. secondary endopoints are the inhibition of platelet aggregation after aa baseline and at 1h, 4h and 24h, and measurement of aggregation with other platelet test (adp, collagen and vasp).

Eligibility criteria:
inclusion criteria: * aged \> 18. * patients with st-segment myocardial infarction. * signed written informed consent. exclusion criteria: * known allergies to aspirin, clopidogrel, prasugrel or ticagrelor. * cardiogenic shock or hemodinamic instability. * recent antiplatelet therapy (\<14 days). * oral anticoagulation with a coumarin derivative. * any active bleeding or blood dyscrasia. * recent gastrointestinal bleeding (\<6 months prior to inclusion). * recent history of stroke, tia or intracranial bleeding (\<6 months prior to inclusion). * known anemia, trombopenia or severe chronic kidney/liver disease * any known active neoplasm. * pregnant females.

Keywords: st-segment elevacion myocardial infarction, platelets
imaging with opto-acoustics to downgrade bi-rads classification relative to other diagnostic methodologies (maestro)

Conditions: Breast Cancer

Summary: imagio breast imaging system, is an opto-acoustic (oa) imaging system designed to concurrently collect images in conjunction with diagnostic ultrasound ( co-registered oa and b-mode imaging). this medical device has ce-marking and is approved for use in europe and other nations. this is a post-market, non-randomized multi-center surveillance study.

this is a post-market surveillance study that is prospective, controlled, multi-center, to evaluate if imagio oa can downgrade bi-rads ( breast imaging-reporting and data system) classification following cdu (conventional diagnostic ultrasound) for the visualization and characterization of suspicious masses prior to core needle biopsy (cnb) or excision. investigators will perform cdu to reach a diagnosis and decision to biopsy. imagio oa will not be used as the reason to perform or to defer a cnb (core needle biopsy) or excision.

Eligibility criteria:
inclusion criteria * female * 18 years of age or older * have an undiagnosed suspicious finding which may include more than one solid or complex cystic suspicious mass, classified by cdu as bi-rads 4a or 4b within 3 weeks of their baseline imagio scan exclusion criteria: * have a condition or impediment that could interfere with the intended field of view (within one probe length or 4 cm of the mass), (i.e., breast implants within the previous 12 months, or tattoos) * pregnant or lactating * patient has received chemotherapy for any type of cancer within 90 days from date of screening cdu

Keywords: breast imaging diagnosis breast ultrasound imagio seno medical instruments, inc. seno opto-acoustics oa
oral tramadol versus diclofenac for pain relief before outpatient hysteroscopy:

Conditions: Pain, Procedure

Summary: the purpose of this study is there difference between the effect of tramadol orally and diclofenac orally with respect to : analgesic efficacy during diagnostic hysteroscopy in nulliparous women.

this prospective double-blind, randomized, clinical trial, will be conducted at ain shams university maternity hospital- early cancer detection unite \[ecdu\]. patients fulfilling inclusion and exclusion criteria will be divided into three groups. group a (study group) include 34 patients who will receive tramadol 100mg orally 1 hour before the procedure. group b (study group) include 34 patients who will receive diclofenac 100mg orally 1 hour before the procedure. group c (control group) include 34 patients who will receive a placebo. pain will evaluate on two separate occasion: immediately after the procedure and 15 minutes after procedure using a 100mm line visual analog scale.

Eligibility criteria:
inclusion criteria: * bmi raging between (18.5 - 30 ). * scheduled for diagnostic hysteroscopy only. * all of them should have given informed written consent. exclusion criteria: * any contraindication to hysteroscopy (e.g. suspected pregnancy, genital tract infection). * receiving any other form of analgesia. * patients with known cervical stenosis, polyps and ulcers. * previous cervical surgery. * patients who are planning to have invasive intrauterine therapeutic interventions during the hysteroscopy. * known sensitivity to non-steroidal anti-inflammatory and opioids drugs. * known gastritis or peptic ulcer or cardiac disease or respiratory dysfunction. * unwilling to comply with the protocol, and participation in another clinical trial in the last three months prior to the start of this study
prospective registry of epicardial lv leads placed during cardiac surgery procedures

Conditions: Chronic Heart Failure

Summary: the primary purpose of this study is to compare the time, risk and cost savings of 2 patient groups who receive fda approved left ventricular pacing leads.

the purpose of this study is to: a) examine the usefulness of placing an epicardial lv lead at the time of open chest surgery in patients who are likely to benefit from a crt system following their surgery; b) compare differences between patients who receive lv leads using the transvenous approach and those patients who receive lv leads using the epicardial approach; and c) assess the cost effectiveness of placing the lv lead via the transvenous versus the epicardial approaches.

Eligibility criteria:
inclusion criteria: 1. left ventricular ejection fraction \< or = 35% 2. qrs duration greater than or = to 120ms 3. nyha functional class 3 or 4 4. age \> or = to 18 years exclusion criteria: 1. no previous pacemaker or icd implant 2. no permanent atrial fibrillation