Kornimate/medical-research-clean huggingface dataset:
microrna of human epidermal growth factor receptor 2 （her2）positive patient treated with herceptin

Conditions: Breast Cancer

Summary: this projective observational study is planned to enroll more than 300 advanced breast cancer patients, who were proved as her-2 positive using fluorescence in situ hybridization (fish) and / or immunohistochemistry, and 100 healthy donors as control. before treatment, the plasma microrna will be collected and detected by microrna extraction kit and quantitative polymerase chain reaction (qpcr), respectively. after analyzed their microrna expression by microrna predictive model, previously reported by our team, all of enrolled patients will be classified as "probable sensitive group" or "probable resistant group". herceptin combined with other chemotherapy will be the backbone of salvage treatment and used for at least 3 months; the change of local masses and metastasis lesions after treatment will be documented to evaluate the response. based on these results, investigator aim to construct a mathematical predictive model by analyzing the correlation of baseline microrna expression level and the prognosis of patients. and a diagnosis microrna kit will be planned and manufactured


Eligibility criteria:
inclusion criteria: 1. the patients signed the written informed consent 2. female patient who is ≥ 18yrs, 3. her2 positive: immunohistochemistry (+++) or fish (+) 4. stage iv 5. the patients have no history of chemotherapy ,hormone therapy,radiotherapy or surgery after diagnosis of breast cancer 6. the result of patients' blood tests are as follow: wbc≥3.0×109/l; plt≥100×109/l;ast/sgot or alt/agpt≤tripple of normal upper limit; creatinine\<double of the normal upper limit 7. ecog scores are 0 or 1 . 8. the patient is able to take oral pills exclusion criteria: 1. the patient was never exposed to herceptin. 2. the patient suffered from other non-breast malignancy in the last 5 years, except for cervical carcinoma in situ, radical basal cell carcinoma or squamous cell carcinoma. 3. the life expectancy is less than 3 months. 4. severe hepatic function disorder, child pugh grade c. 5. severe cardiac function disorder, cardiac function is more than grade iii; 6. prolonged qt interval; 7. arrhythmia or taking anti-arrhythmia drugs; 8. pregnant or breast feeding female.

Keywords: breast cancer herceptin microrna
post market evaluation of acessa with tag

Conditions: Uterine Fibroids

Summary: the purpose of this study is to test both user preference and speed of targeting with the use of the acessa system with targeting animation guidance (tag).

the intent of the tag system is to assist the gynecologist in getting the tip of the acessa handpiece to the fibroid by creating an animated image overlay of the movements and placement. the study will be conducted in two parts: part 1: user preference testing - users will be presented with various statements pertaining to the features of the system and asked to indicate their degree of agreement. part 2: time to target - will be measure by fibroid.

Eligibility criteria:
inclusion criteria: women who: * are planning to undergo the acessa procedure * are willing and able to comply with all procedures * are capable of providing informed consent exclusion criteria: women who: * in the medical judgement of the investigator should not participate in this study

Keywords: acessa fibroids halt targeting animation image overlay radiofrequency ablation rfa
cognitive-based compassion training (cbct) for people living with hiv (plhiv)

Conditions: Human Immunodeficiency Virus

Summary: the purpose of the study is to examine the effects of cognitive-based compassion training (cbct), a meditative practice based on buddhist teachings, on long term emotional well-being and immune system improvement with people living with human immunodeficiency virus (plhiv).

the proposed study will investigate the efficacy of cognitive-based compassion training (cbct), a contemplative technique based on the tibetan buddhist tradition of compassion meditation, for enhancing immune restoration and psychological resilience in people living with hiv-1 (plhiv). psychosocial stress has been associated with increased circulating concentrations of key inflammatory biomarkers. the patients with hiv must cope with the physical impact of hiv disease itself, the often complex treatment regimens and side effects of combination antiretroviral therapy (art), illness-associated psychological and existential dilemmas, changes in social roles and lifestyle patterns relative to illness progression, social stigma, and financial and material resource concerns. this study aims to determine if engagement with cbct is associated with reduced circulating concentrations of stress-related inflammatory biomarkers, improves hiv-related clinical outcomes and decreases stress in plhiv.

Eligibility criteria:
inclusion criteria: 1. subjects living with hiv-1 infection who have been on continuous art for a minimum of 12 months and: * are followed longitudinally for their hiv healthcare at the infectious disease program * meet criteria for immunological non-responsiveness as defined by adherence to art and cluster of differentiation 4 (cd4) count \ 2 plasma hiv viral load (pvl) below the limit of detection including the most recent pvl prior to enrollment). 2. ability to give informed consent. 3. score at least 1 standard deviation above socioeconomic status (ses)-matched general population norms on perceived stress scale (pss) exclusion criteria: 1. history of psychosis 2. hiv-related neurocognitive decline 3. substance abuse within the last year 4. documented history of cirrhosis or a total bilirubin ≥ 2.0 mg/dl 5. known or possible pregnancy or attempting to become pregnant 6. bmi below 17 or above 30 7. age \< 18 8. bipolar disorder 9. bleeding disorders such as thrombocytopenia or significant gastrointestinal bleeding within the past year 10. continuous art for \< 12 months

Keywords: cognitive-based compassion training (cbct) hiv-related clinical outcomes stress and stress-related psychological adjustment stress-related inflammatory biomarkers
electrical stimulation to promote recovery in bells palsy

Conditions: Bell Palsy

Summary: a feasibility pilot study to exam the necessary methodology for conducting a larger clinical trial for bell's palsy patients with a poor prognosis and the use of electrical stimulation.

here we describe a protocol for a prospective, randomized, double-blinded study to evaluate the effects of monophasic pulsed current es on patients with bell's palsy and factors predicting poor recovery, with a 6 month follow up. motor level stimulation with a pulse duration of 100 μsec and a frequency of 35 pulses per second were chosen from focus group with physical therapist to treat facial paralysis and are consistent with clinical trials showing motor benefit after capel tunnel surgery.

Eligibility criteria:
inclusion criteria: * new diagnosis of bell's palsy (diagnosed in the last 30 days) * if younger than 60 years of age must have complete paralysis on one side of face or both * if older than 60 years of age paralysis must be present but can be incomplete. exclusion criteria: * paralysis associated with any of the fallowing: cancer, tumor, surgery, stroke, or trauma. * younger than 60 years old with incomplete paralysis. * non english speakers * pacemaker or deep brain stimulator

Keywords: facial paralysis bell palsy electrical stimulation
polymorphisms in key genes of glycolytic pathway: influence on radiosensitivity in nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma; Single Nucleotide Polymorphisms; Radiosensitivity

Summary: warburg effect is an important feature of tumors,and genetic variation is one of the main factors of individual differences to radiotherapy treatment response for nasopharyngeal carcinoma(npc). through the previous work investigators found that the p53 codon72 (pro/arg) was related to the prognosis of npc; using the method of proteomics, investigators discovered glycolysis related gene such as pgk1, aldoa，was associated with radiosensitivity.thus,with all the previous work,investigators hypothesize that the key gene polymorphisms in glycolytic pathway, such as p53 , influence the glycolytic pathway,which leads to differences in radiosensitivity of npc. this projects will include 600 cases of patients with npc to detect common glycolytic key genes polymorphisms. besides,investigators correlate these factors with their radiosensitivity and prognosis.then, prediction model will be established, and validation of the prediction model will be done. using enzyme-labeling instrument ，comet assay and clonogenic assay，cytological experiments will further investigate the influence of key gene polymorphisms on the glycolysis efficiency and mechanism of radiation sensitivity.thus,investigators could provide theoretical basis of individualized treatment for npc.


Eligibility criteria:
inclusion criteria: * pathological identified npc * kps≥70 * tolerable and agree for imrt and concurrent chemotherapy * without severe other diseases * informed consent exclusion criteria: * reject treatment * cannot tolerate the treatment * distant metastasis before treatment
a clinical trial of chemotherapy with lobaplatin and 5-fu in recurrent local or distant advanced npc.

Conditions: Recurrent Nasopharyngeal Carcinoma

Summary: the purpose of this study is to evaluate the efficacy and safety of chemotherapy with lobaplatin and 5-fu, in recurrent local or distant advanced nasopharyngeal carcinoma.


Eligibility criteria:
inclusion criteria: * npc diagnosed by pathology, with measurable lesions and imaging results, such as mri and ct. patients with no other lesions but bone metastasis are excluded. * recurrent locally or distant advanced npc (rt3-4n0-3m0-1) * ecog 0 or 1 * expected survival ≥ 1 year * without dysfunction of heart, lung, liver, kidney and hematopoiesis * patients are voluntary and signed informed consent * no other anti-tumor treatment (including steroid) exclusion criteria: * allergy history to platinum * use of 5-fu in last 6 months * had major surgery in last 4 weeks, or the wound has not completely healed * toxicity from previous treatment is still ≥ctc ae grade 3 * history of other carcinoma in the past 5 years, except for treated carcinoma in situ of cervix, as well as basal cell carcinoma or squamous cell carcinoma of the skin * dysfunction of heart * bleeding ≥ctc ae grade 3 * use of anticoagulant or vitamin k antagonists, except for small dose of aspirin and warfarin for prevention * patients participated in clinical trials of other drugs within last 4 weeks * mental illness

Keywords: recurrent nasopharyngeal carcinoma lobaptin
evaluation of brain mri and clinical characteristics of adolescents with bipolar disorder and children of parents with bipolar disorder

Conditions: Bipolar Disorder

Summary: genetic transition is important in the etiology of bipolar disorder (bd). so, evaluation of children of bd parents and diagnosed with and bd children whether or not brain has affected zones. these groups were compared to healthy controls and whether or not the mental health of children is influenced will be evaluated by the clinical investigation.

mri studies in children at risk of bd, our understanding of the neurobiology of bd and abnormalities in the studied regions, regions that predispose to the development of our understanding of pbb will shed light on the etiology of the disorder. in this study, the cranial mri findings and clinical features in adolescents with bipolar disorder and the same age and sex matched children who have parents with bd and healthy controls were investigated. since there is few studies that evaluate these three groups, there is a need to increase our knowledge on this issue.

Eligibility criteria:
inclusion criteria: * children with bd between the ages of 12-18 * parents with bd who have children between the ages of 12-18 * healthy children whose parents do not have bd * patients who does not have mental or organic disability to answer the questions * graduated from primary school exclusion criteria: * patients who have mental or organic disability to answer the questions * patients who have a history of any chronic disease which is likely to affect the central nervous system * patients who have a contraindication for any first application for magnetic resonance imaging (mri)

Keywords: bipolar disorder children cranial mri
effects of lidocaine infusion on quality of recovery and agitation after functional endoscopic sinus surgery

Conditions: Chronic Polypous Rhinosinusitis

Summary: the essential anesthesia requirements for fess include airway management, considerations for facilitating surgical access, provision of a clear and still surgical field for precision surgery, assuring quick and non-stimulating emergence from anesthesia, and fast-tracking patients for discharge. postoperative agitation, although short-lived, is potentially harmful to both patients and recovery room staff, it has a potential for self-injury by removing intravenous catheters, tubing, oxygen masks and nasal packs. furthermore, very agitated patients can pose an immediate danger to operating theatre staff.

lidocaine is an amino amide-type short-acting local anesthetic (la). it has a short half-life, and a favorable safety profile, and is therefore the la of choice for continuous iv administration, it has analgesic, and anti-inflammatory effects that are induced by reduction of cytokines production through inhibition of neutrophil activation, and the analgesia may persist even after plasma concentration reduction. it can blunt the pressor response to endotracheal intubation also systemic lidocaine was effective in producing controlled hypotension.

Eligibility criteria:
inclusion criteria: * patients scheduled for elective functional endoscopic sinus surgery; * asa class i-ii, * aged (20-60 years). exclusion criteria: * body mass index \>35 kg/m2 * history of allergic reaction to local anesthetic agents especially lignocaine. * history of preoperative use of opioids. * patients with history of uncontrolled hypertension, a-v conduction block. * history of sleep apnea.
trial of exercise to reduce cancer related fatigue in breast cancer

Conditions: Cancer Related Fatigue

Summary: like other cancer treatments, radiation therapy can make people feel fatigued, or tired. the investigators think that moderate exercise, done 15 minutes at a time, can reduce the fatigue. this study is designed to gather more information, so that in the future, doctors can recommend whether patients should engage in exercise during a radiation treatment course.

cancer related fatigue (crf) is a common and debilitating side effect of radiotherapy in breast cancer patients. physical activity interventions can attenuate crf. the proposed study is a randomized, controlled trial (rct) of exercise of structured moderate-intensity exercise intervention, delivered concurrently with radiotherapy, to reduce crf and improve health-related quality of life among breast cancer patients. eighty women with breast cancer scheduled to receive radiation therapy at hackensack university medical center (humc) will be randomized to one of the two trial arms:1) a facility-based aerobic exercise utilizing a portable stationary pedal exerciser; or 2) a control group. intervention arm participants will exercise at the hospital either before or after their radiation treatment. assessments will be conducted at baseline, 4 weeks into radiation course, and at 4-week follow-up visit. the outcome variables are crf, biomarkers of inflammation, and health-related quality of life (qol). the study will provide preliminary evidence on whether a short-term moderate-intensity exercise intervention might be effective in reducing crf in women undergoing radiotherapy for breast cancer, and whether this effect is mediated by inflammation.

Eligibility criteria:
inclusion criteria: 1. women between the ages of 18 and 75 years 2. histologically confirmed non-metastatic carcinoma of the breast (in situ disease or invasive) 3. radiation therapy naïve 4. sedentary activity level at baseline, as defined by less than 60 minutes per week of modest physical activity based on 7-day physical activity recall questionnaire 5. ambulatory 6. negative serum pregnancy test and not planning to become pregnant in the next three months 7. able to provide meaningful consent. 8. patients must have been deemed by their medical oncologist or internist that they "may participate in \[this\] exercise trial." prior to randomization, participants are required to complete a physical activity readiness questionnaire (par-q) that includes questions regarding physical and medical conditions that would preclude safe participation in an exercise program. exclusion criteria: 1. younger than 18 or older than 75 years 2. no histological confirmation of breast cancer 3. prior breast, chest, or pelvic radiotherapy 4. concurrent chemotherapy 5. distant metastases 6. physical limitations that contraindicate participation in low to moderate intensity exercise 7. positive pregnancy test 8. currently engaged in moderate to vigorous physical activity 9. psychiatric disorder which would render the participant unable to provide informed consent.

Keywords: radiation therapy for breast cancer
efficacy and safety of intravenous diazepam given at 2 different doses compared to placebo in acute peripheral vertigo

Conditions: Vertigo, Peripheral

Summary: this is prospective, randomised double-blind study that will be conducted in the emergency department of 3 university hospitals (fb monastir, sahloul sousse, and fh sousse) to compare the efficacy of two doses of diazepam (valium®) and placebo for the relief of acute periphery vertigo in the ed

this is prospective, randomised double-blind study that will be conducted in the emergency department of 3 university hospitals (fb monastir, sahloul sousse, and fh sousse) to compare the efficacy of two doses of diazepam (valium®) and placebo for the relief of acute periphery vertigo in the ed. the study should be reviewed and receive approval from the institutional review board. principles of the helsinki declaration are considered all patients should provide their informed consent prior to enrollment.

Eligibility criteria:
inclusion criteria; * patients between 18 and 70 years of age * a chief complaint of acute peripheral vertigo (apv) (sensation of spinning, which was worsened by movement and sudden in onset) were eligible if the treating emergency physician diagnosed an episode of vertigo that was peripheral in nature. exclusion criteria: -patients aged \> 70 years as central vertigo , -patients with a focal neurologic deficit, pregnancy, history of allergic reaction or contraindication to any of the test drugs, history of enrolment in a previous clinical drug trial, * history of recent ingestion (within 24 hours) of a sedative, antihistamine, antipsychotic, or opioid, * history of syncope or cardiac event, considerations of a central origin for vertigo -evidence of drug-induced vertigo or orthostatic hypotension -history of mental or neurological illness.

Keywords: vertigo diazepam placebo
prospective trial of ivl for calcified carotid lesions(create trial)(extended follow-up)

Conditions: Carotid Artery Stenosis

Summary: purpose: to assess the long-term safety and efficacy of the intravascular lithotripsy system for pre-treatment of calcified carotid artery stenosis. design: prospective, multicenter, single-arm study with an extended follow-up period. sample size: 204 participants (based on the final number of cases enrolled in the registration trial). endpoints: primary: surgical success rate (residual stenosis \<30% after stenting). secondary: target lesion re-narrowing rate, target lesion revascularization rate, mae rate, ipsilateral stroke rate, and macce rate at 3 and 6 months postoperatively. follow-up: participants will be followed up at 3 months ±15 days and 6 months ±30 days postoperatively. inclusion criteria: all patients participating in this extended follow-up period are sourced from the registered clinical trial. ethics and consent: the trial will be conducted in accordance with the helsinki declaration and chinese regulations. informed consent will be obtained from all participants or their legal guardians. sponsor: shanghai lanfan boyuan medical technology co., ltd. principal investigator: professor huo xiaochuan, beijing anzhen hospital.

### detailed description this clinical trial evaluates the safety and long-term efficacy of a disposable neurovascular intravascular lithotripsy (ivl) catheter and intravascular lithotripsy treatment device for pre-treatment of calcified lesions in the extracranial segment of the carotid artery. the study is designed as a prospective, multicenter, single-arm trial （extended follow-up period）. #### study population: all patients participating in this extended follow-up period are sourced from the registered clinical trial.（the registered clinical trial:participants aged 18-80 years with symptomatic (≥50%) or asymptomatic (≥70%) calcified carotid artery stenosis confirmed by ct angiography (cta) and digital subtraction angiography (dsa) are eligible. patients who have failed conventional balloon dilation and are planned for carotid artery stenting (cas) will be included.） #### follow-up: participants will be followed up at 3 months ±15 days and 6 months ±30 days postoperatively. assessments will include clinical evaluations, imaging studies (ct angiography or carotid ultrasound), and recording of adverse events. * endpoints: * \*\*primary endpoint\*\*: surgical success rate defined as residual stenosis \<30% after stenting. * \*\*secondary endpoints\*\*: target lesion re-narrowing rate, target lesion revascularization rate, mae (major adverse events) rate, ipsilateral stroke rate, and macce (major adverse cardiovascular and cerebrovascular events) rate at 3 and 6 months postoperatively. * ethical considerations: informed consent will be obtained from all participants or their legal guardians. the study will be conducted in accordance with the helsinki declaration and local regulatory requirements.

Eligibility criteria:
inclusion criteria: all patients participating in this extended follow-up period are sourced from the registered clinical trial. exclusion criteria: none
automatic urine output measuring device performance validation and efficacy.

Conditions: Urine Output Decreased

Summary: to evaluate the efficacy of serenno medical automatic urine output measuring device in patients with indwelling urinary catheter hospitalized in the cardiac surgery intensive care unit.

in order to evaluate the efficacy of serenno medical automatic urine output measuring device we will perform a non inferiority of study device in compare with urinometer (with acceptance of 3% standard deviation), in patients hospitalized in the intensive care unit after cardiac surgery. secondary endpoints are to attribute and identify urine output changes prior to early stage acute renal failure, and identifying urine output changes prior to fluid overload or dehydration.

Eligibility criteria:
inclusion criteria: * subjects, aged \>18 years * patients hospitalized in the intensive care unit requiring an indwelling urinary catheter for urine output monitoring for at least 24 hours. exclusion criteria: * known urological pathology including but not limited to nephrolithiasis, polycystic kidney disease, congenital abnormalities of the kidneys and or urinary tract, history of obstructive uropathy, advanced chronic kidney disease (stage 4) of any cause. * known pregnancy or lactating women. * cognitive and/or psychiatric impairment which may not allow cognitive signing on the informed consent unless patient has a legal representative that was appointed prior to patient enrollment.