Kornimate/medical-research-clean huggingface dataset:
effıcıency of hybrıd based sımulatıon method in breastfeedıng educatıon

Conditions: Breastfeeding; Training Group, Sensitivity; High Fidelity Simulation Training; Medical Simulation; Standardized Patient

Summary: it was planned to determine the effect of hybrid simulation-based breastfeeding training on the practical skills, satisfaction, self-confidence and self-efficacy of the students of the department of midwifery, hamidiye faculty of health sciences, university of health sciences

this study was planned to determine the effect of hybrid simulation-based breastfeeding education on the practical skills, satisfaction, self-confidence and self-efficacy of the students of the department of midwifery, hamidiye faculty of health sciences, university of health sciences. the research, planned in a randomized controlled experimental design, will be conducted with istanbul health sciences university hamidiye health sciences faculty midwifery 2nd year students (n: 84). students participating in the study will be divided into intervention (n: 42) and control (n: 42) groups according to the computer-assisted simple random sampling technique. both groups will be given 4 hours of theoretical information about breast milk and breastfeeding education before the application. 42 students assigned to the intervention group will receive training with a high-reality simulator fitted to a standard patient, accompanied by a scenario, and 42 students assigned to the control group will receive practice training with an adult standard patient care model. introductory information form, simulation-based learning evaluation scale, student satisfaction and self-confidence in learning scale, self-efficacy-sufficiency scale, breastfeeding management skill evaluation form will be applied to the students participating in the research. as a result of the findings, discussion and conclusions of the study will be written. it is important to increase the competency level of midwifery students in breastfeeding management in a simulation environment that creates virtual reality, before the care applied on real patients in a clinical environment. it is recommended to integrate high-reality simulators and standard patient methods into the curriculum in the education of midwifery students . this study aims to increase the application skills, satisfaction, self-confidence and self-efficacy levels of midwifery department students with hybrid simulation-based breastfeeding education, in which two or more simulation types (standard patient and lactation simulator) are combined to produce a more realistic simulation experience.

Eligibility criteria:
inclusion criteria: having a statement of consent being a second year midwifery student exclusion criteria: wishing to withdraw from the research at any time. not participating in all simulation applications incompletely filling out data collection forms

Keywords: simulation based breastfeeding training breast feeding midwifery education simulation standardized patient high fidelity simulation training
the indiana myeloma registry

Conditions: Plasma Cell Dyscrasias

Summary: this is a prospective, non-interventional, observational study. the purpose of this study is to collect data and bio-specimens that will support future research


Eligibility criteria:
inclusion criteria: 1. male or female patients ≥ 18 years of age at the time of informed consent 2. has been diagnosed with or is suspected to have one of the following: 1. monoclonal gammopathy of undetermined significance (mgus) 2. smoldering multiple myeloma 3. multiple myeloma 4. bony or soft tissue plasmacytoma 5. primary amyloidosis exclusion criteria: \< 18 years of age have not been diagnosed with one of the following: monoclonal gammopathy of undetermined significance (mgus) b.smoldering multiple myeloma c.multiple myeloma d.bony or soft tissue plasmacytoma e.primary amyloidosis

Keywords: multiple myeloma monoclonal gammopathy of undetermined significance plasmacytoma smoldering multiple myeloma
anti-pd-1 antibody treatment with cemiplimab and radiotherapy in early-stage classical hodgkin lymphoma

Conditions: Hodgkin Lymphoma

Summary: the primary objective is to estimate the efficacy of experimental treatment with the anti-pd-1 antibody cemiplimab (regn2810) in combination with simultaneous or subsequent radiotherapy (rt) in early-stage favorable classical hodgkin lymphoma (chl). secondary objectives are to assess the safety and feasibility of the 2 experimental strategies.


Eligibility criteria:
key inclusion criteria: * histologically proven classical hl * first diagnosis, no previous treatment * stage i-ii without risk factors as defined in the protocol key exclusion criteria: * composite lymphoma or nodular lymphocyte-predominant hodgkin lymphoma (nlphl) * prior malignancy within the previous 5 years (except for locally treatable cancers that have been apparently cured by complete resection) * prior chemotherapy or radiation therapy * concurrent disease precluding protocol treatment as defined in the protocol * pregnancy or breast-feeding * non-compliance as defined in the protocol note: other protocol-defined inclusion/exclusion criteria apply

Keywords: early stage favorable classical classical hodgkin lymphoma (chl)
study of blood platelets in sickle cell disease

Conditions: Sickle Cell Disease

Summary: we are studying if sickle cell disease blood platelets are larger than normal and how they may cause obstruction of blood vessels. we are also trying to study the reasons why large platelets are found in patients with sickle cell disease.

research volunteers are seen in the outpatient research center by the principal investigator or another physician. a detailed history is obtained, a physical examination is performed, and blood (usually 4 tablespoons) is obtained for additional tests. the research volunteer's previous medical records will be requested. upto 5 additional blood samples may be obtained in a subgroup of patients.

Eligibility criteria:
inclusion criteria: * adults and children \> 7 years of age with sickle cell disease (hb ss) who are not taking hydroxyurea and are not receiving routine blood transfusion therapy. exclusion criteria: * current hydroxyurea therapy or, * hydroxyurea use within the past 3 months * blood transfusion or exchange transfusion within the past 3 months * current treatment with aspirin or clopidogrel
effects of cdp-choline on gating and cognitive deficits in first episode schizophrenia

Conditions: First Episode Schizophrenia

Summary: people with schizophrenia tend to have problems with attention and concentration. studies found that these patients are unable to block or gate out non-relevant and distracting information (e.g., noises). this may lead to brain overload. cognitive abilities like concentration, memory, and learning may worsen. this ability to filter sensory information has been linked to a gene that affects the way nicotine acts in the brain. patients with schizophrenia have a high rate of cigarette smoking. 60% to 90% smoke compared with 25% of the general population. it has been suggested that these patients may use nicotine to improve their ability to block out distracting information. brain wave activity (eeg) in response to sounds has been proved useful in understanding this gating problem. the present study uses eeg measures and performance tasks to find out what a new nicotine-like treatment, which will be added to ongoing treatment medications, does to gating and cognition. it is hoped that this new treatment will improve the way in which patients process information, as this may help them in day-to-day activities.

* a sample of 40 patients will be recruited from the champlain first episode psychosis program, a service of the ottawa hospital, which is run in conjunction with the schizophrenia program of the royal ottawa mental health center. * in this randomized, double-blind, placebo-controlled, cross-over design study, participants will attend the laboratory for four test sessions and will receive either a single dose of cdp-choline (500 mg, 1000 mg or 2000 mg) or placebo at each test session * eeg recordings (with a focus on the p50 erp) and cognitive testing measures will be collected in each test session to determine any possible gating or cognitive effects of cdp-choline. a saliva sample will also be collected to determine any genetic differences in the effects of cdp-choline * the investigators carefully engineered study aims to assess the optimal dosing of a nicotinic cholinergic agonist, cdp-choline to increase p50 suppression and cognitive efficacy in an early schizophrenia population with abnormal p50 suppression.

Eligibility criteria:
inclusion criteria: * male or female * 18 - 60 years old * meet dsm-iv/dsm-iv-tr criteria for first episode schizophrenia * clinical stability of the past 2 months \[assessed with the panss\] * treatment with a single antipsychotic medication (concomitant psychiatric medications allowing on an "if needed basis". * smoker or non-smoker exclusion criteria: * any comorbid axis i disorder including a current or recent history of alcohol/substance abuse * a clinically significant medical illness or organic brain disorder known to cause psychosis or cognitive impairment * recent head trauma (\<6mos) * major learning disability * body mass index \>38kg/m¬2 * use of illicit drugs * abnormal hearing
hypofractionated radiation fractionation in breast cancer patients with implant-based reconstruction

Conditions: Breast Cancer

Summary: it is a randomized trial to assess the safety and efficacy between hypofractionation radiation and conventional radiation in women who have undergone mastectomy and immediate breast reconstruction. the investigators will evaluate reconstruction complication, radiotherapy side effects, cosmetic and oncologic outcomes.

patients with breast cancer frequently have requirement for breast reconstruction after mastectomy. for patients with limited autologous tissue availability, implant-based reconstruction remains an effective alternative. due to the absence of high-level evidence, collaborative efforts between surgical and radiation oncology teams are advised to determine the optimal sequencing and techniques for integrating reconstruction surgery with radiotherapy. the ongoing alliance a221505 and fabrec phase iii randomized controlled trials are comparing the incidence of reconstructive complications following hypofractionated and conventional fractionation radiotherapy. fabrec trial recently showed the hypofractionated regimen did not significantly improve change in physical well-being（pwb), domain of the functional assessment of cancer therapy-breast (fact-b) quality-of-life assessment tool, compared with the conventional fractionation radiotherapy. this trial added to the increasing experience with hf pmrt in patients with implant-based reconstruction. in 2019, the european society for radiotherapy and oncology (estro) provided guidelines for target delineation based on the position of the implant in breast reconstruction to minimize the irradiation of normal tissues. existing studies on the risk of complications from irradiating expanders and implants have yielded inconsistent conclusions, with each approach having its own advantages and disadvantages. our study aims to compare the incidence of reconstructive complications between hypofractionated and conventional fractionation radiotherapy after implant-based reconstruction surgery to provide high-level evidence for medium-dose hypofractionated radiotherapy after immediate implant-based reconstructive surgery.

Eligibility criteria:
inclusion criteria: 1. pathological diagnosis of stage i-iii breast cancer (non-t4), \>18 years old; 2. complete breast cancer resection (including skin-sparing and nipple-sparing total resection) 3. according to the guidelines of the chinese anticancer society, postoperative adjuvant radiotherapy is required; 4. undergo immediate reconstructive surgery (tissue dilator or permanent implant) exclusion criteria: 1. auto-reconstruction surgery 2. clinical or pathological t4 3. both sides need radiotherapy 4. have a history of chest radiotherapy 5. pregnancy/lactation 6. participate in other drug clinical trials

Keywords: implant-based reconstruction surgery hypofraction radiation therapy
liposomal bupivacaine interscalene nerve block in shoulder arthroplasty

Conditions: Arthropathy Shoulder

Summary: the objective of this study is to determine if peripheral nerve block with liposomal bupivacaine in combination with standard bupivacaine will prolong the duration of block, improve pain scores, and decrease opioid utilization in the post-operative period when compared to peripheral nerve block with standard bupivacaine alone.

this is a prospective, single-blinded randomized clinical trial comparing outcomes in patients undergoing total shoulder arthroplasty (anatomic and reverse) who receive a peripheral nerve block with liposomal bupivacaine in combination with standard bupivacaine versus standard bupivacaine alone. once consent is obtained, baseline characteristics will be recorded and patients will be randomized to intervention or control. following surgery, patients will be followed until their 3-week post-operative visit. the primary outcome measure will be the mean difference in patient pain scores over the first 72 hours post-operatively between two groups. secondary outcomes will include: (1) total opioid consumption (as measured utilizing morphine intravenous equivalents) in first 72 hours and at 3 weeks (2) patient perceived duration of block determined as the time patient perceives complete resolution of block (3) patient satisfaction with pain control at 72 hours, 3 weeks post-operatively and patient reported outcome measures (sane, sst, ases, vr-12) at 3 weeks post-operatively.

Eligibility criteria:
inclusion criteria * all adult patients (\>18 years of age) * patients undergoing standard or reverse total shoulder arthroplasty for the primary diagnoses of glenohumeral arthritis or cuff tear arthropathy * cognitively intact with the ability to give informed consent as outlined by our institutional review board. * patients must be capable of participating in the post-operative electronic survey and / or able to maintain a written diary of events exclusion criteria * non-elective cases * infection, tumor, trauma * weight \< 50 kg * patients with any contraindications to regional anesthesia including allergy or hypersensitivity to amide-type local anesthetics * patients with allergy to any component of medication regimen e.g. amide- type local anesthetics, oxycodone, hydromorphone, fentanyl * chronic pain patients with history of chronic opioid use (defined as 20 mg morphine equivalent / day for greater than 30 days pre-operatively * concurrent painful physical condition that may require analgesic treatment that is not related to the shoulder surgery (chronic peripheral neuropathy, radiculopathy, or other neurologic disorder) * severe hepatic disease defined by clinical evidence of liver disease with abnormal liver function tests. * pregnancy * respiratory disease that contraindicates interscalene nerve block (elevated contralateral hemidiaphragm, contralateral pneumonectomy, or severe copd with fev1 \< 50% predicted, and 02 dependence)
a study to describe the diagnostic and therapeutic path of patients with nsclc in early stage and locally advanced

Conditions: Non-small Cell Lung Cancer; NSCLC; NSCLC, Stage III; NSCLC, Stage I

Summary: this is a non-interventional, retrospective observational study to improve knowledge regarding the diagnosis and treatments of patients who have/had non-small cell lung cancer (nsclc), either early stage (stage i-ii).

due to heterogeneity of patients with stage i-iii non small cell lung cancer (nsclc), there is not a unique common therapeutic approach and there is no consensus about the optimal timing, sequencing and combination of surgery, chemotherapy and radiotherapy across the spectrum of early stage and locally advance disease. consequently, the choice of local treatment modality can vary across countries and centers.

Eligibility criteria:
inclusion criteria: 1. patients with stage i-iii nsclc who have received curative surgery or radiotherapy between january 2018 and june 2019 with available follow-up through january 2021 2. adult patients (aged ≥ 18 years) at the moment of diagnosis 3. patients (or their legally acceptable representatives) must have signed and dated the informed consent form; privacy form (icf). in case of deceased or untraceable patient the investigator before collecting data shall demonstrate and report all necessary measures adopted to contact the patient. exclusion criteria: 1. patients without availability of medical charts or information required 2. enrollment in studies imposing a specific patient's management strategy which does not correspond to the site's normal clinical practice.

Keywords: nsclc early stage nsclc locally advanced retrospective observational study real-world evidence
safety and activity study of intrathecally administered ziconotide for neuropathic pain in patients with cancer

Conditions: Pain; Neuropathic Pain; Intractable Pain; Cancer

Summary: neuropathic pain is difficult to control because it is only partially sensitive to opioid analgesics, and requires the addition of other therapies such as antidepressants and epileptics. ziconotide is a drug that is used to treat neuropathic pain in patients who have had inadequate pain control with prior combination of medicines.

the purpose of this study is to evaluate the effects and the tolerability of intrathecal ziconotide in cancer patients suffering from severe neuropathic pain not controlled by previous therapies.

Eligibility criteria:
inclusion criteria: * diagnosis of neoplasm * neuropathic pain level vaspi \> or = 6 (0-10 scale) * inadequate pain relief with opioid analgesics and adjuvants * age \> or = 18 years * performance status ecog 0-2 * life expectancy at least one month * adequate contraception in women of child-bearing potential * signed informed consent exclusion criteria: * use of experimental drugs within previous 30 days * pregnancy or lactation * contraindication to the use of intrathecal analgesics, including active infection or conditions that could alter the circulation of cerebrospinal fluid * presence of cerebral metastasis * inr \> 2 * contraindication to the use of ziconotide * unable or unwilling to provide informed consent
chemoprevention of oral premalignant lesions

Conditions: Precancerous Conditions

Summary: reduction in size and number of oral premalignant lesions


Eligibility criteria:
inclusion criteria: * 8mm oral premalignant lesion that has not been biopsied in the past 6 months exclusion criteria: * taking \>100mg daily dose of nsaids (non-steroidal anti-inflammatory drugs)
airway management in morbidly obese patients: a comparison of intubating laryngeal mask fastrack and air q as a conduit for fiberoptic intubation

Conditions: Intubation; Difficult or Failed

Summary: to compare air q versus ilma intubation in obese adult paralyzed patient

evaluate the process of endo-tracheal intubation through air q compared to through ilma regarding number and duration of attempts, laryngeal view grade, time to removal of device over tube without dislodgement and any complication

Eligibility criteria:
inclusion criteria:all morbidly obese patient defined as bmi \>40 kg/m2 scheduled for an elective surgery requiring general anesthesia with tracheal intubation were enrolled on the day of their surgery. asa physical status (i-ii) exclusion criteria physical status of iv or v or had a history of impossible tracheal intubation or awake fibreoptic intubation or if preoperative evaluation showed limited mouth aperture \<3.5 cm or showed evidence that an awake fiberoptic intubation or rapid sequence induction would be required patients at increased risk for aspiration of gastric contents, coagulopathy or those with unstable cervical spines or requiring nasal route for tracheal intubation -
a double blind placebo-controlled, parallel group study to assess the efficacy and safety of frovatriptan in the acute treatment of migraine

Conditions: Migraine

Summary: the purpose of this study is: 1. to compare the efficacy of a single dose of frovatriptan 2.5 mg with that of placebo in acute treatment of up to one migraine attract 2. to assess recurrence rate between two group 3. to assess the safety and tolerability


Eligibility criteria:
inclusion criteria: 1. adults aged 18 to 65 years 2. the patients must have a history of migraine according to the criteria of the headache classification committee of the international headache society(ihs), over the previous 1 year. the patient must have experienced one to eight moderate or severe migraine attacks(with or without aura) each month over at least the previous two months 3. onset of migraine disease must have occurred before the patients was 50 years of age 4. able and willing to sign informed consent, and able and willing to comply with study procedures, including the completion of diary cards. exclusion criteria: 1. pregnant or lactating females, or women intend to become pregnant or breast feed during the study period, or women of childbearing potential not using adequate contraception. females of reproductive potential must have a negative pregnancy test at screening 2. clinically significant renal dysfunction(creatinine≥2.0mg/dl) or hepatic dysfunction(alt,ast≥2 uln) 3. patients with clinically significant abnormal ecgs or with resting diastolic blood pressure above 95mmhg 4. patients with clinically significant cardiovascular or cerebrovascular disease 5. patients with a history of clinically relevant allergy, including allergy to triptan 6. previous treatment with frovatriptan at any time or treatment with an investigational drug within 30 days before screening visit 7. patients with a diagnosis of vertebrobasilar or hemiplegic(prolonged atypical aura) migraine(ihs criteria) 8. potentially unco-operative patients, those unable to provide informed consent, and those unable to complete the diary 9. patients who habitually abuse headache medication including ergotamine-containing compounds, and patients with a history of alcohol and/or medicine abuse, in the investigator's opinion 10. patients who are not able to tell that they are having a migraine headache 11. patients who have 15 or more headache days per month, on average, or those taking symptomatic medication for headaches on more than two days per week, on average 12. treatment with a monoamine-oxidase inhibitor(maoi) within two weeks of the screening visit 13. patients who are taking prophylactic migraine medication, unless dose has been stabilized for 30 days and it expected to continue for the duration of the study
urethral sensory profile: a new technique to evaluate urethral sensation prospective evaluation in patients with or without neurological disorders

Conditions: Urethral Cyst

Summary: this is a routine evaluation of urethral sensation during urodynamic studies. the record has been realized retrospectively. the investigators propose a new way to represent urethral sensation, in a simple and non-invasive way.

all patients consulting for urodynamics were included. during the introduction of the urinary catheter for urodynamic evaluation, patients were asked to report pain and/or desire to void felt at every centimeter (cm)of insertion, on an analogic visual scale graded from 0 to 10. the usp was defined by the graphic representation of the successive values of these sensations , from the urinary meatus, to the urinary bladder.

Eligibility criteria:
inclusion criteria: * patients consulting in our department for a urodynamic study exclusion criteria: * chronic pelvic pain * difficulties for understanding or for communicating

Keywords: urodynamics urethral sensation urethral pain