Kornimate/medical-research-clean huggingface dataset:
neoadjuvant study with pyrotinib and trastuzumab and abraxane in patients with her2-enriched breast cancer

Conditions: Breast Cancer

Summary: breast cancer is kind of highly heterogeneous tumor. the patients with the same stage and with the same treatment regimen, their prognosis varies greatly, mainly due to the different phenotypes of breast cancer and different sensitivities to drug therapy. pma50 and blueprint classification divides breast cancer into other inherent subtypes: luminal a, luminal b, her2-enriched (her2-e) and basal-like. previous studies have shown that these patients with inherent subtype of her2-enriched are more likely to obtain higher pcr after anti-her2 therapy. and more study and meta analysis had demonstrated the higher pcr is closely related to efs. the genetic and molecular typing of breast cancer is closely related to the prognosis of breast cancer, so it is imperative to seek a new treatment regimen for precision treatment and maximize the therapeutic benefit of her2-enriched patients.


Eligibility criteria:
inclusion criteria: 1. female patients, 18 years ≤ age ≤ 75 years； 2. performance status- eastern cooperative oncology group (ecog) 0-1 3. histologically confirmed invasive breast cancer（early stage or locally advanced） 4. her2 positive (her2+++ by ihc or fish+), and the her2-enriched subtype screened by buleprint test; 5. primary breast cancer; 6. known hormone receptor status. 7. the organs are functioning normally, like the liver function, the renal function， and the baseline left ventricular ejection fraction (lvef)≥55% measured by echo 8. signed informed consent form (icf) exclusion criteria: 1. metastatic disease (stage iv) or inflammatory breast cancer 2. previous or current history of malignant neoplasms, except for curatively treated:basal and squamous cell carcinoma of the skin,carcinoma in situ of the cervix. 3. clinically relevant cardiovascular disease:known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); 4. a history of allergy to the drugs in this study； 5. unable or unwilling to swallow tablets

Keywords: her2-enriched, pyrotinib, neoadjuvant therapy, pcr
determinants of the level of anti-sars-cov-2 igg antibodies after vaccination study in patients after organ transplantation

Conditions: SARS-CoV2 Infection; SARS-CoV2 Antibodies

Summary: great expectations to control the pandemic are placed in vaccines against covid-19. currently, the four covid-19 vaccines approved in the european union. the investigators designed a study assessing the anti-sars-cov-2 igg antibody titer after vaccination cycle with the bnt162b2 vaccine in several time points relating these results to the covid-19 history and severity of symptoms during the disease and after the first and second vaccine dose.

the study includes patients of antoni jurasz university hospital no.1 in bydgoszcz after organ transplantation. to meet the inclusion criteria patients will have to be vaccinated with two doses of the bnt162b2 vaccine. the assessment of the anti-sars-cov-2 igg antibody titer at several time points in each participant. fresh serum samples were used to measure sars-cov-2 igg on the siemens atellica system (siemens healthineers, erlangen, germany). results of sars-cov-2 igg were given as u/ml, whereby the cut-off for positivity was defined as ≥1.0 u/ml.

Eligibility criteria:
inclusion criteria: * provision of informed consent to study * age ≥ 18 years * receiving two doses of the bnt162b2 vaccine * patients post organ transplantation exclusion criteria: * patients who did not complete 2-dose vaccination schedule * patients who received any other vaccine than bnt162b2 * patients considered by investigator to be unable to cooperate
efficacy of intrathecal oxytocin in patients with neuropathic pain

Conditions: Neuropathic Pain

Summary: the purpose of the study is to determine the effect of oxytocin given into the spinal fluid on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic neuropathic pain.

rationale: the investigators anticipate that oxytocin will be effective after spinal injection in humans to acutely relieve chronic neuropathic pain. objectives: determine the effect of intrathecal oxytocin on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic neuropathic pain. interventions: a computer generated randomization will be used to determine the group for each subject. subjects will be randomized to receive an intrathecal injection of saline (placebo) or oxytocin.

Eligibility criteria:
inclusion criteria: * weight \< or equal to 240 pounds * neuropathic pain for \> 6 months: with primary pain area below the umbilicus exclusion criteria: * hypersensitivity, allergy, or significant reaction to any ingredient of the study drug or lidocaine * any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the principal investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data * pregnancy * spinal cord stimulators, chronic intrathecal drug therapy, or oral opioid treatment for \> 3 months at a current dose of \> 100 milligram (mg) morphine per day or equivalent.

Keywords: chronic pain neuropathic pain
mechanical nerve stimulation in the treatment of post prostatectomy incontinence

Conditions: Urinary Incontinence; Radical Prostatectomy

Summary: during transcutaneous mechanical nerve stimulation in spinal cord injured men an increase in pressure was observed in the external urethral sphincter along with an increase in bladder capacity. in a subsequent study it was demonstrated that transcutaneous mechanical nerve stimulation (tmns) in women could induce pressure increment of the external urethral sphincter. a pilot study have since shown that after 6 weeks of stimulation 24 out of 33 women suffering from urinary stress incontinence were able to contract their pelvic floor muscles and had become free of symptoms. another pilot study has shown promising effect on the overactive bladder syndrome. furthermore pilot studies in men who are incontinent after a radical prostatectomy have shown promising results. a randomized investigation of tmns applied in the immediate period after a radical prostatectomy to investigate effects on both continence and erectile function is on going. the present study aims to treat urinary incontinence in men who are still incontinent more than 1 year after a radical prostatectomy. a medical vibrator is used daily for a period of 6 weeks and the results of the treatment is then evaluated. the participants will be randomized to 2 groups. group 1 starts vibration treatment at base line and group 2 starts after 6 weeks when group 1 is done. the groups are compared at baseline, at 6 weeks and at 12 weeks. the stimulation will be performed at the frenulum of the glans penis every day for 6 weeks with an amplitude of 2 mm and a frequency of 100 hz. results will be evaluated on the basis of questionnaires, micturition diaries and diaper tests. if the investigators are able to demonstrate a significant reduction in the incontinence symptoms in the subjects the investigators asses that vibration can be a way of reestablishing normal continence in men after a radical prostatectomy.


Eligibility criteria:
inclusion criteria: * men who have undergone a radical prostatectomy at least 1 year prior to enrollment * incontinence induced by the surgery (at least 8 g/24 hours) * capable of understanding study information and following treatment exclusion criteria: * incontinence before radical prostatectomy * treatment with anticholinergic medications * radiation or hormone treatment * previous surgical treatment of incontinence * acute illness (including infection, trauma and haematuria) * faecal incontinence * known neurological disease * known bladder pathology on cystoscopy

Keywords: stress incontinence incontinence prostate cancer radical prostatectomy vibration nerve stimulation
clinical trial to assess the safety of reducing the time of bed rest after cardiac catheterization

Conditions: Coronary Artery Disease With Myocardial Infarction

Summary: reducing the rest time after diagnostic cardiac catheterization for three hours does not increase the complications concerning to the procedure, compared to the rest of five hours.

reducing the rest time after diagnostic cardiac catheterization for three hours does not increase the complications concerning to the procedure, compared to the rest of five hours. the aim of this study is to compare through a randomized clinical trial to reduce the rest time in bed for five hours after elective diagnostic cardiac catheterization, with a 6f sheath with a transfemoral approach, for a period of three hours of the occurrence of bleeding, hematoma, pseudoaneurysm and a vasovagal reaction.

Eligibility criteria:
inclusion criteria: * age equal too or above 18 years * patients undergoing elective diagnostic cardiac catheterization on an outpatient basis and * who agree to participate by reading and signing the informed consent form. exclusion criteria: * patients with restriction ambulation; * users of coumarin anticoagulants; * imc greater than 35 kg/m2; * patients with hypertension (systolic pa \> 180 mmhg and diastolic pa \> 110 mmhg) at the end of the procedure

Keywords: cardiac catheterization safety nursing care rest patients
phase i/ii study of sgi-110 with irinotecan versus regorafenib or tas-102 in metastatic colorectal cancer

Conditions: Previously Treated Metastatic Colorectal Cancer

Summary: this is a phase i/ii study of the combination of guadecitabine (sgi-110) and previously treated metastatic colorectal cancer patients. this study will be conducted in two components. first, patients will be enrolled in a phase i study of sgi-110 combined with irinotecan in a standard 3+3 design. after the maximum tolerated dose (mtd) is determined, patients will subsequently be enrolled in a 2:1 randomized phase ii study of sgi-110 and irinotecan versus the standard of care regorafenib or lonsurf (tas-102).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the colon or rectum * phase i only: patients with biopsiable disease amenable to having two research biopsies. * have measurable disease * phase ii only: progressed while receiving irinotecan therapy in the metastatic setting. there are no limitations on number of prior therapies in the metastatic setting. * life expectancy of greater than 12 weeks. * eastern cooperative oncology group (ecog) performance status \<1 * normal organ and marrow function as defined by study-specified laboratory tests * must use adequate contraception through the study and for 3 months after last dose of study drug. exclusion criteria: * chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) of first dose of study drug or who have not recovered from treatment-related adverse events * receiving any other investigational agents * participants with known brain metastases * history of allergic reactions attributed to compounds of similar chemical or biologic composition to irinotecan, decitabine or sgi-110. * received prior therapy with any hypomethylating agents. * uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * pregnant or nursing women * history of a different malignancy are ineligible with exceptions (disease-free for at least 5 years with low risk for recurrence, cervical cancer in situ, definitively treated early stage prostate cancer, definitively treated breast ductal or lobular carcinoma in situ, and basal cell or squamous cell carcinoma of the skin). * hiv-positive individuals on combination antiretroviral therapy * phase ii only: previous treatment with regorafenib and tas-102. if patients have previously received either regorafenib or tas-102, they must be able to receive the alternate regimen if randomized to standard of care (arm b). * hospitalization for an acute medical issue within 4 weeks prior to screening visit * symptomatic bowel obstruction within 6 months prior to enrollment, patients who undergo surgical correction of obstructing lesion will be eligible within 6 months.

Keywords: sgi-110 irinotecan regorafenib methylation colorectal metastatic tas-102 lonsurf
anxiety and chronic postsurgical pain following ambulatory surgery in children

Conditions: Ambulatory Surgery; Children, Only; Inguinal Hernia; Umbilical Hernia; Urologic Surgery

Summary: prospective, monocentric, observationnal study. the primary objective of this study is to identify if presurgical child or/and parental anxiety is predictive of chronic postsurgical pain in abdominal or urologic ambulatory surgery.

the post surgical pain guidelines recommend to identify predictive factors, especially for vulnerable subjects. for children, there is few data about predictive factors of postoperative pain after ambulatory surgery. the objective of this study is to collect preoperative data (preoperative children's anxiety and parental anxiety) and postoperative data (postoperative pain measure: the day of surgery and 3 months after surgery) for children undergoing abdominal ou urologic ambulatory surgery, and to determine if there is a relationship between these data (odds ratio)

Eligibility criteria:
inclusion criteria: * child from 3 to 18 years old * undergoing scheduled urology or abdominal ambulatory surgery * child and parents speaking french * affiliation to national health insurance exclusion criteria: * emergency surgery * lack of parents consent * no parental support on surgery day

Keywords: pediatric department children chronic postsurgical pain perioperative anxiety
the effect of nutrition education given by pecha kucha method on preventing malnutrition to cancer patients receiving radiotherapy

Conditions: Preventing Malnutrition

Summary: the leading goal of cancer treatment is to eradicate the cancer. if the primary goal is not achieved, it is aimed to prolong life, improve quality of life, or improve symptoms. cancer treatments are divided into two basic groups as local and systemic. systemic treatments include chemotherapy, hormone therapy, targeted molecular therapy, immunotherapy treatments. local treatments are; ablative approaches that include surgery, cryotherapy, radiotherapy and radiofrequency. radiotherapy (rt) is a treatment method in which ionizing beam is used. the aim of radiotherapy in cancer treatment is to destroy the tumor, if this is not possible, to provide palliative treatment. radiotherapy uses ionizing radiation in the form of electromagnetic waves (x-rays, gamma rays) or particles for this purpose. pecha kucha (pk), meaning "chat voice" or "chat" in japanese, refers to a well-crafted, fast and concise presentation format. in a pk presentation, each presenter is only allowed to show 20 powerpoint slides for 20 seconds each on a timer. in other words, the presenter has only 20 seconds to discuss each slide before the next slide appears, and the presentation time is limited to 6 minutes and 40 seconds. ideas are explained visually with pictures and graphics, and slides have little text.

according to the report of the world health organization, the increase in cancer is predicted to be over 70% by 2020 in developing countries. while a significant increase in the life span of cancer patients has been achieved with effective multi-faceted treatment approaches in recent years, nutritional problems related to cancer and cancer treatment have begun to emerge as an important factor in quality of life and survival. early detection of nutritional disorders and initiation of necessary nutritional support are of great importance in increasing the effect of radiotherapy and chemotherapy, reducing infection rates, increasing clinical response and life expectancy. pecha kucha (pk), meaning "chat voice" or "chat" in japanese, refers to a well-crafted, fast and concise presentation format. in a pk presentation, each presenter is only allowed to show 20 powerpoint slides for 20 seconds each on a timer. in other words, the presenter has only 20 seconds to discuss each slide before the next slide appears, and the presentation time is limited to 6 minutes and 40 seconds. ideas are explained visually with pictures and graphics, and slides have little text.

Eligibility criteria:
inclusion criteria: * • patients over 18 years of age * patients receiving radiotherapy for the first time * patients with cachectic and diagnosed mental problems * patients who can read and write or who can get support from their relatives * patients who can be contacted exclusion criteria: -
information about hiv transmission and circumcision on subsequent sexual behavior, and the demand for circumcision

Conditions: Sexual Behavior; Dis-inhibition

Summary: the purpose of this study is to measure the behavioral effects of learning information about male circumcision and hiv risk on sexual behavior and the demand for male circumcision.


Eligibility criteria:
inclusion criteria: * the study will involve men between the ages of 25 and 40 exclusion criteria: * none

Keywords: malawi risk compensation male circumcision demand
post-marketing safety study of gsk biologicals' boostrix® vaccine

Conditions: Diphtheria; Tetanus; Acellular Pertussis

Summary: pre-licensure studies of gsk biologicals' boostrix® have shown it to be generally safe and well-tolerated. this post-licensure study is designed to evaluate relatively uncommon/rare outcomes in a large population cohort. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

data collection through utilization of automated databases at the study site. the collaborator is kaiser permanente vaccine study center.

Eligibility criteria:
inclusion criteria: * subjects between the age of 10 and 18 years (inclusive) who received a dose of boostrix and who have safety follow-up information available

Keywords: boostrix
a peer-oriented hiv prevention outreach program for individuals at high risk for hiv and other stis

Conditions: HIV Infections; Sexually Transmitted Diseases

Summary: this study will determine the effectiveness of a peer outreach intervention in preventing hiv infection in adults at high risk for contracting hiv and other sexually transmitted diseases (stds).

the persistence of hiv and std epidemics indicates that more effective, sustainable preventive interventions are needed, particularly for low-income, inner-city populations. this study will determine the effectiveness of a theoretically based peer outreach program in preventing hiv and std transmission among adults in the baltimore, maryland area. participants will be randomly assigned to receive either a network-oriented peer program emphasizing one's social identity and the goals of protecting one's family and community or group cognitive behavioral therapy (cbt). the peer program will also train participants to provide hiv/std education to their peers. participants will be assessed at study entry and during several subsequent follow-up visits. at these study visits, participants will complete questionnaires about their sexual health knowledge and sexual behaviors. participants and members of their peer network will have follow-up visits at months 6, 12, and 18.

Eligibility criteria:
inclusion criteria for cbt or peer intervention participants: 1. female 2. age 18-55 3. did not inject drugs in the past 6 months 4. self-reported sex with at least 1 male partner in the past 6 months 5. had at least 1 of the following sexual risk factors: 1. more than 2 sex partners in the past 6 months 2. sti diagnosis in the past 6 months 3. had a high risk sex partner in the past 90 days (i.e. a sex partner that injected drugs, smoked crack, was hiv+, or msm) inclusion criteria for peer network participants: 1. 18 years old or older 2. one of the following: 1. injected drugs 2. sex partner of index 3. social network member that the index felt comfortable talking to about hiv/stis exclusion criteria for all participants: * currently enrolled in another hiv prevention intervention

Keywords: sex education peer group social identity theory hiv seronegativity intervention women social networks peer education
the heartflow coronary disease progression evaluation study

Conditions: Coronary Artery Disease

Summary: invasively measured fractional flow reserve (ffr) has proven to be useful in guiding coronary revascularization. several studies have shown that it is justified to treat lesions with a value of 0.80 or lower and safe to defer from pci in lesions with a value of \>0.80. recently, computational fluid dynamics have allowed ffr measurement from coronary computed tomography angiography images (ffrct) with excellent diagnostic accuracy compared to invasive ffr. ffrct can also effectively guide revascularization safely deferring patient with ffrct \>0.80 from invasive angiography. in functionally non-significant lesions, computational fluid dynamic models in addition to ct plaque characteristics (low attenuation, positive remodelling, spotty calcification and napkin-ring sign) may be able to predict which lesions will become flow-limiting, causing clinical events in the future. this study will evaluate disease progression in intermediate lesions (invasive ffr 0.81-0.90 at baseline) using ffrct at 2 years and determine whether ct characteristics may help to identify lesions that are more susceptible for ffr decline. additionally, we will correlate ct characteristics with coronary events (a composite endpoint consisting of all-cause mortality, target-vessel myocardial infarction and clinically driven target-vessel revascularization) up to 5 years after the baseline invasive ffr.


Eligibility criteria:
inclusion criteria: 1. patients (age ≥ 18 years) treated with pci (for non-st elevation myocardial infarction, unstable or stable angina and silent ischemia) or who undergo invasive ffr. 2. minimum of one non-treated coronary artery with an intermediate lesion and invasive ffr 0.81-0.90 to serve as the target vessel for ffrct. exclusion criteria: 1. st elevation myocardial infarction. 2. previous cabg. 3. target vessel for ffr measurement \< 2.0 mm in diameter. 4. contraindications to contrast agents, beta-blocking agents, nitroglycerin or adenosine. 5. life expectancy less than 3 years. 6. creatinine clearance \< 30 ml/min\*1.73m2.

Keywords: fractional flow reserve coronary computed tomography angiography computational fluid dynamics plaque characteristics
foot core exercise training with telerehabilitation

Conditions: Rheumatoid Arthritis; Foot Core; Exercise

Summary: the aim of this study was to investigate the effects of lower extremity exercises combined with foot core exercise training on lower extremity pain, foot functionality, static and dynamic parameters of gait, and postural stability in individuals with rheumatoid arthritis using synchronous and asynchronous telerehabilitation methods.


Eligibility criteria:
inclusion criteria: * having been diagnosed with rheumatoid arthritis * being between the ages of 18-65 * being willing to participate in the study exclusion criteria: * having a neurological disease * having a pulmonary or cardiovascular problem that may affect daily life activities * sensory system disorders * having a history of surgery on the lower extremities or trunk * experiencing dizziness * having a cognitive disorder * having an additional rheumatic disease