Kornimate/medical-research-clean huggingface dataset:
combination of nanoxel and herzuma in salivary duct carcinoma

Conditions: Salivary Duct Carcinoma

Summary: 1. study outline this is a multicenter, single-arm, phase ii trial to evaluate the efficacy and safety of nanoxel plus herzuma combination chemotherapy in patients with metastatic salivary ductal cancer. approximately 41 patients will be enrolled. treatment will be continued until disease progression or unacceptable toxicities. response evaluation will be performed every 2 cycles. 2. dosing \& treatment schedule d1 nanoxel 75 mg/m2 + d5w 100ml miv over 1hr d1 herzuma 8mg/kg (loading dose) + n/s 250ml miv over 90mins 6mg/kg (maintenance) + n/s 250ml miv over 30mins (since 2 cycle) repeated every 3 weeks (in case of discontinuation of nanoxel without progression, single agent herzuma can be administered until progression)


Eligibility criteria:
inclusion criteria: * histologically-confirmed her2 positive (immunohistochemistry \[ihc\] 3+, and/or fluorescence in situ hybridization\[fish\] positive with ≥ two-fold amplification) salivary duct carcinoma(sdc), and other salivary gland carcinomas which are similar to sdc in histopathological findings, including adenocarcinoma, not otherwise specified, acinic cell carcinoma, squamous cell carcinoma, anaplastic carcinoma, high grade mucoepidermoid carcinoma, and carcinoma ex pleomorphic adenoma * stage iv or recurrent cancer * age ≥ 20 years * ecog performance status 0-2 * at least one measurable tumor lesion according to recist 1.1 * expected survival for approximately 12 weeks or longer * no prior systemic chemotherapy * at least 4 weeks later after surgery or radiotherapy * written informed consent exclusion criteria: * severe or unstable cardiac disease, including (for example) coronary artery disease requiring increased doses of anti-anginal medication and/or coronary angioplasty (including stent placement) within the preceding 24 months(congestive heart failure nyha iii or iv, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias) * uncontrolled systemic illness such as dm, hypertension, hypothyroidism and infection * pregnant and nursing women (women of reproductive potential have to agree to use an effective contraceptive method) * current, known cns malignancy (history of completely resected or irradiated brain metastases by wbrt or stereotactic radiosurgery allowed) * patients with alcohol abuse
abc mental health: a behavioral study of k-12 teachers and school staff

Conditions: Mental Health Wellness 1; Burnout, Professional; Self Efficacy

Summary: this study looks at school employees' mental health, well-being, and effectiveness before and after completing a professional development workshop. the participants' schools are offering the cultivating awareness and resilience in education (care) professional development workshop to all teachers, staff, and administrators. care will be presented in three in-person training sessions over two to three months during the school year. people who participate in care are asked to answer questions about their demographic information, mental health, well-being, and effectiveness before the workshop and two times after completing the workshop. this consent form provides the necessary information for people interested in answering these questions to make an informed decision. this consent form is not for the professional development workshop. taking part in the workshop and questionnaires is optional. this study is being conducted because teachers, school staff, and children's mental health has declined since the beginning of the covid-19 pandemic. the investigators hope to use information collected in this study to tell schools, local public health officials, and state leaders how best to support teachers' mental health and well-being. there are minimal risks associated with this study. the greatest risk of this study is loss of confidentiality.


Eligibility criteria:
inclusion criteria: * adult participant, defined as an adult (18 years or older) employed by a school working with youth in kindergarten through 12th grade. * fluent in the english language exclusion criteria: * n/a
efficacy of auditory training and combined auditory-working-memory training in improving communication in older adults

Conditions: Hearing Loss

Summary: using a randomized controlled trial, we are going to examine whether a training program that incorporates both auditory training and working memory training (at-wmt) would generate significantly better results in communication and cognition than an auditory training program and a mindfulness training program (active-control). participants are 120 older adults (40 per group) with untreated mild-to-moderate sensorineural hearing impairment .

there will be three training groups: the auditory training (at) group, the auditory-working memory training (at-wmt) group, and the control group (mindfulness training). all training programs are home-delivered, non-clinician-administered, and computer-based. that is, training will be self-paced and administered by the participants themselves at home using a computer. a software program (see figure 2) has been created to facilitate the administration of the at and at-wmt. all training groups will spend one hour per day and five days per week for 4 weeks. before the training, two baseline test sessions (t1 and t2, a maximum of one week apart) will be used to account for the test-retest effects. the same measurements will be administered again one day (t3) and three months (t4) after completion of the training.

Eligibility criteria:
inclusion criteria: * native cantonese speakers and having been living in hong kong for at least 20 years. * aged between 55 and 80 years. * normal cognitive function, as screened with the hong kong version of montreal cognitive assessment (hk-moca) with a cutoff of 18/19. * mild-to-moderate sensorineural hi, in which the four-frequency pure-tone average at 500, 1000, 2000, and 4000 hz of the better ear is between 26 and 55 db hl. exclusion criteria: * outer or middle ear pathologies. * wearing hearing aids or cochlear implants. * no computers and internet access at home.

Keywords: auditory training working memory speech perception older adults hearing loss
a study of baclofen er

Conditions: Cocaine Dependence

Summary: this is a phase ii, randomized, double-blind, placebo-controlled study that will examine the efficacy of extended-release baclofen (baclofen er) for the treatment of cocaine dependence. the primary study outcome will be urines positive for benzoylecgonine (be), a metabolite of cocaine, submitted during outpatient treatment (12-week) and follow-up (12-week). to examine brain mechanisms of relapse/recovery, participants will complete fmri sessions before, during, and after treatment. brain responses to specific probes of reward and inhibition will be used as biomarkers predicting drug use during and after the treatment.


Eligibility criteria:
inclusion criteria: 1. physically healthy cocaine-dependent (based on dsm-iv- tr criteria) male or female aged 18-60 yrs, voluntarily seeking treatment for cocaine dependence. 2. females must be non-pregnant, non- lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation or at least 1 year post-menopausal) or of child bearing potential, but practicing a medically acceptable method of birth control. examples of medically acceptable methods for this protocol include barrier (diaphragm or condom) with spermicide, an intrauterine device (iud), oral contraceptives, a levonorgestrel implant, intrauterine progesterone contraceptive system, medroxyprogesterone acetate contraceptive injection, and abstinence. 3. reading level at or above eighth grade. 4. participants provide voluntary informed consent. 5. smoking is primary route of cocaine administration. 6. available for an inpatient stay. exclusion criteria: 1. participation in clinical trial and receipt of investigational drug(s) during previous 60 days, except as explicitly approved by the principal investigator. 2. clinically significant cardiovascular, hematologic, hepatic, renal, neurological or endocrinological abnormalities. 3. history of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes or associated with skull fracture or inter-cranial bleeding or abnormal mri. 4. presence of magnetically active prosthetics, plates, pins, broken needles, permanent retainer, bullets, etc. in patient's body (unless a radiologist confirms that its presence is unproblematic). an x-ray may be obtained to determine eligibility. 5. claustrophobia or other medical condition that disables the participant from lying in the mri for approximately 60 minutes. 6. current or prior gambling problems (assessed by participants self-report) 7. non-removable skin patches 8. have received medication that could interact adversely with baclofen, including muscle relaxants (including tricyclic antidepressants), antiseizure medication, cns depressants (tranquilizers, sleeping pills), mao inhibitors), within the time of administration of study agent based on the study physician's guidance (e.g. 5 half lives) 9. have known or suspected hypersensitivity to baclofen. 10. be taking baclofen for any reason currently or during the past year.

Keywords: cocaine treatment fmri outcomes
the effects of bolus, intermittent and continuous enteral feeding on blood glucose and feeding intolerance in icu patients with sepsis

Conditions: Enteral Feeding Intolerance

Summary: comparison of the effects of bolus, intermittent and continuous enteral feeding techniques on plasma glucose level and enteral feeding intolerance in adult intensive care unit patients with sepsis.

in this prospective, controlled trial the main aim is to evaluate the effects of bolus, intermittent and continuous enteral feeding techniques on plasma glucose level in intensive care patients with sepsis diagnosis and to determine whether they are superior to each other in providing norma-glycemia. the secondary aim is to determine the effect of these 3 different enteral feeding techniques on enteral feeding intolerance.

Eligibility criteria:
inclusion criteria: * hospitalized in icu for more than 3 days * ages between 18-70 years * apachi ii is in the range of 8-25 * bmi in the range of 18.5-30 * able to receive enteral nutrition from n/g * intubated on ventilator support * no previous diagnosis of diabetes mellitus, * those who have not had gastro intestinal system surgery in the last 6 months * patients not receiving inotropic support * not receiving hemodiafiltration * no history of allergy to the food used * patients with a focus of infection and/or culture-positive patients diagnosed with sepsis according to q sofa (cultures were taken from all patients) exclusion criteria: * patient's death during the study * taking more than 40 mg of iv steroids daily * increased baseline apachi ii score * development of the patient's need for inotropes * elimination of inclusion criteria * negative culture

Keywords: plasma glucose levels, enteral feeding intolerance enteral feeding methods sepsis
safety and efficacy of umbilical cord mesenchymal stem cell therapy for patients with hereditary ataxia

Conditions: Hereditary Ataxia

Summary: the hereditary ataxias are a group of genetic disorders characterized by slowly progressive incoordination of gait and often associated with poor coordination of hands, speech, and eye movements. current treatments for hereditary ataxias are mainly pharmacological, rehabilitative, or psychological treatments，while no effective treatment available. stem cell therapy is a novel and promising therapeutic strategy for hereditary ataxias treatment. in this study, the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation will be evaluated in patients with hereditary ataxias.

this study is designed to evaluate the the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients with hereditary ataxias.

Eligibility criteria:
inclusion criteria: * aged 16-65 years. * harding diagnosis of scas, gene type confirmed. * candidates who did not receive any stem cell therapy in past 6months. * sign the consent form and follow the clinic trail procedure. exclusion criteria: * cardiac insufficiency; renal insufficiency; hepatic insufficiency; total bilirubin higher than 1.5 times of upper limit of normal value; ast /alt higher than 2.5 times of upper limit of normal value； * routine blood test: wbc count \<3.0×109/ l; plt count \<5×109/l ; or hemoglobin \<100g/l； * combined pneumonia or other severe systemic bacteria infection； * severe drug allergic history or anaphylaxis to 2 or more food or medicine； * other brain organic disease (eg. brain cancer)； * hiv+, tumor markers + ； * severe psychotic patients, cognitive dysfunction， or can not understand or sign the consent form； * other severe systemic or organic disease； * uncontrolled hypertension，blood pressure≥180mmhg/110 mmhg after treatment； * pregnancy； * enrollment in other trials in the last 3 months； * other criteria the investigator consider improper for inclusion.

Keywords: human umbilical cord mesenchymal stem cells
needs assessment after cancer in patients treated for breast cancer

Conditions: Breast Neoplasm Female; Quality of Life; Fear Cancer

Summary: observational monocentric study

observational monocentric study primary objective : describe post-cancer supportive care needs, assessed by questionnaire in patients treated for breast cancer after completion of treatment and 2 years later. secondary objective : * correlation between needs after cancer and the fear of recidivism assessed by the scale of the inventory of fear. * compare the need for supportive care between the end of treatment and 2 years after. * assess needs after cancer according to the stage of the disease * evaluate the needs after cancer according to the treatments received: surgery-radiotherapy versus surgery-chemotherapy-radiotherapy. * assess needs after cancer according to age and socio-professional category. schedule : the selected patients then received a letter including an information and non-objection note, the post-cancer needs questionnaire, the fear inventory severity subscale questionnaire, and the qlq-c30 questionnaire. a delay of 1 month was chosen to return the questionnaire with a phone call after 15 days for an analysis of responses in february 2019.

Eligibility criteria:
inclusion criteria: women who have been treated for breast cancer and whose treatment ended in 2017 (cohort a) and in 2015 (cohort b), aged between 18 and 80 years, and who declared their non-opposition free and enlightened. exclusion criteria: patients who have been treated for recurrence or 2nd cancer, metastases from the outset, male, refusal to participate.
quetiapine compared with placebo in the management of fibromyalgia

Conditions: Fibromyalgia

Summary: is quetiapine more effective than other medications in the treatment of fibromyalgia.

this study is a double blind, placebo controlled, 24-week crossover design. for 12 weeks subjects receive either study medication (200mg quetiapine) or placebo, after which they will be switched to the other treatment for an additional 12 weeks. between treatments, subjects are required to undergo a 1-week washout where no drug is given in order to clear the effects of the first treatment. at each visit subjects will complete the following assessment: fibromyalgia impact questionnaire, pittsburgh sleep quality index, beck depression inventory, state-trait anxiety inventory, and short form health survey. temperature, blood pressure, pulse rate, weight and waist circumference will also be recorded. physical exams and blood tests will be performed at 1, 12, and 25 weeks

Eligibility criteria:
inclusion criteria: * age 18 to 60, inclusive * females of childbearing potential using reliable method of contraception and negative urine pregnancy test. * widespread pain present for at least 3 months * widespread encompassing both sides of the body, as well as above and below the waist * pain in at least 11 of 18 tender points as determined by a physician exclusion criteria : * pregnant or breastfeeding * use of any of the following in the 14 days prior to enrollment: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine, saquinavir phenytoin, carbamazepine, barbiturates, rifampin, st. john's wort, and glucocorticoids. * administration of a depot antipsychotic injection within one dosing interval (for the depot) before enrollment * substance or alcohol dependence at enrollment (except in full or recovery, and except nicotine or caffeine dependence) * abuse of any of the following within 4 weeks of enrollment: opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen * medical conditions that would affect study treatment * unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by investigator * involvement in the planning and conduct of the study * previous enrollment or randomization of treatment in the present study * participation in another drug trial within 4 weeks prior to enrollment in this study or longer * admitted to hospital for diabetes mellitus (dm) related illness in past 12 weeks * not under physician's care for dm * physician responsible for your dm care has indicated you dm is uncontrolled * physician responsible for your dm care has not approved your participation in the study * have not been on the same dose of dm medicine and/or diet for the 4 weeks prior to starting the study * for thiazolidinediones (glitazones) this period should not be less than 8 weeks * taking insulin whose daily does on one occasion in the past 4 weeks has been more than 10% above or below your mean dose in the preceding 4 weeks * a low white blood cell count

Keywords: fibromyalgia
evaluate the outcomes of ferric carboxymaltose in patients with perioperative anemia

Conditions: Anemia; Anemia (Iron-Loading); Perioperative Bleeding; Infection Prevention; Readmission, Hospital; Surgical Complication; Length of Hospital Stay; Iron Deficiency Anemia Treatment; Prehabilitation

Summary: the prevalence of preoperative anaemia in patients undergoing major surgery is approximately 30%, and is independently associated with higher mortality, a higher rate of postoperative complications, and a greater probability of receiving a transfusion. in a prehabilitation program, the evaluation and correction of anaemia in the preoperative period is essential, as it is a risk factor for transfusions and complications. the main objectives of this study were to analyse the need for blood transfusion, post-surgical complications, hospital length of stay, icu length of stay, hospital readmissions, and surgical wound infection in patients treated with ferric carboxymaltose (fc) before surgery. a total of 152 patients were included, of whom 96 received fc before the intervention and 56 received no treatment (control group).

it was conducted a prospective pre-post interventional study between 1 january 2019 and 31 december 2022 at infanta cristina university hospital in parla (madrid, spain). written informed consent was obtained from each participant. to ensure anonymity and confidentiality, patient data were coded and stored in secure, password-protected databases accessible only to authorized research personnel, in compliance with spanish legislation (organic law 3/2018 and rd 1090/2015). the data used in the study were anonymous and collected by impartial, unpaid, volunteers.

Eligibility criteria:
inclusion criteria: * age over 18 years; on the swl. * hemoglobine \<13g/dl. * referred for major elective surgery requiring hospital admission (e.g., oncologic resections such as mastectomy, colon resection, nephrectomy, hysterectomy), typically involving general anesthesia and moderate to high morbidity risk, capable of understanding and consenting to the study * physically and mentally able to complete assessments exclusion criteria: * patients with hypersensitivity to fc, or any of its excipients. • patients with active bleeding

Keywords: infection anemia length of stay prehabilitation
carbachol´s headache inducing characteristics and effects on the cerebral blood flow

Conditions: Headache

Summary: to investigate headache score and accompanying symptoms during and after infusion of carbachol.

to investigate headache score and accompanying symptoms during and after infusion of carbachol. changes in regional cerebral blood flow (rcbf) in the area supplied by middle cerebral artery (mca), blood flow in mca, diameter of the superficial temporal artery (sta) and radial artery (ra)

Eligibility criteria:
inclusion criteria: * healthy volunteers * aged 18-40 * 50-100 kg * fertile women must use safe contraceptives (iud, oral contraceptives, surgical sterilisation and long lasting gestagen. exclusion criteria: * tension type headache more than once/month * other primary headaches * daily medication except contraceptives * drug taken within 4 times the halflife for the specific drug except contraceptives * pregnant or lactating women * exposure to radiation within the last year * headache within the last 24 hours before start of trial * hypertension * hypotension * respiratory or cardiac disease
stop-bang score and factors predicting difficult intubation for prediction of difficult mask ventilation in obese patients

Conditions: Obesity; OSA

Summary: the goal of this prospective observational study is to test combination of stop-bang score and factors predicting difficult intubation can improve accuracy of prediction difficult mask ventilation in obese patients that undergoing to elective surgery under general anesthesia. the main question\[s\] it aims to answer are: * can combination of stop-bang score and factors predicting difficult intubation improve accuracy of prediction difficult mask ventilation in obese patients? * study about complication after endotracheal tube insertion in obese patients that undergoing to elective surgery under general anesthesia. participants who undergoing to elective surgery under general anesthesia will * routine preoperative evaluation and ask about stop bang questions, evaluate neck circumference, mallampati grade,thyromental distance (that routine physical examination for anesthetic care pre-operation) * in operation room, patients will be inducted anesthesia by anesthesiologist (step routine for general anesthesia),observe difficult mask ventilation grading before intubate endotracheal tube and complication after endotracheal tube insertion. if there is a comparison group: researchers will compare obese patients with/without high stop bang score \>=3 point plus factor predicting difficult intubation (mallampati grade 3-4, neck circumference \> 42 cm, thyromental distance \< 6 cm)to prediction difficult mask ventilation


Eligibility criteria:
inclusion criteria: * bmi ≥ 25 kg/m2 * age \> 18 years old * undergoing elective surgery under general anesthesia with endotracheal intubation exclusion criteria: * history of difficult mask and intubation * maxillofacial or upper airway malformation * history of c-spine disease such as trauma, degeneration * pregnancy * rapid sequence induction technique

Keywords: mask ventilation general anesthesia