Kornimate/medical-research-clean huggingface dataset:
the effectiveness of combined virtual and clinical simulation in midwifery students

Conditions: Simulation Training; Midwifery Students Education; Clinical Competence; Education, Health; Virtual Simulation

Summary: objective: to evaluate the effectiveness of a combined virtual and clinical simulation strategy compared to virtual simulation alone and clinical simulation alone in the development of theoretical knowledge and clinical judgment among midwifery students, specifically in the management of preeclampsia. study population: 75 undergraduate midwifery students in the second cycle of their studies at the universidad de los andes, chile. interventions: group 1: virtual and clinical simulation combined (vsim® case on preeclampsia followed by hands-on clinical simulation with a manikin). group 2: virtual simulation only (vsim® case on preeclampsia). primary outcomes: development of theoretical knowledge (measured by a test) on preeclampsia. improvement in clinical judgment skills (assessed using the lasater clinical judgment rubric). secondary outcomes: student satisfaction with the training. perceived self-efficacy in managing preeclampsia. usability of simulation platform duration: the intervention lasts for 4 days. pre- and post-tests will assess knowledge, clinical judgment, satisfaction, and self-efficacy. methodology: a randomized controlled trial (rct) with 35 participants divided equally into two groups. each group will undergo either virtual simulation, or both. data analysis will involve repeated measures anova to assess the differences in learning outcomes between the groups.


Eligibility criteria:
inclusion criteria: * enrollment status: students in the second cycle of the midwifery program at the university of los andes. * educational background: participants must have completed the foundational courses in obstetrics and gynecology, as well as their initial clinical rotations. * consent: participants must provide written informed consent to participate in the study. exclusion criteria: * previous clinical experience: students who have had prior clinical experience in high-risk obstetric units, or in preeclampsia management, will be excluded. * other professional backgrounds: individuals with a degree or professional certification in obstetric or gynecological nursing (e.g., technicians with a title in obstetric nursing) will not be eligible. * exchange students: midwifery students participating in exchange programs will not be permitted to participate in the study.

Keywords: virtual simulation clinical simulation clinical judgment randomized clinical trial preeclampsia
zanubrutinib-based maintenance therapy of newly diagnosed dlbcl with initial remission

Conditions: Diffuse Large B Cell Lymphoma

Summary: this single-arm, prospective clinical study will evaluate the efficacy and safety of zanubrutinib-based maintenance therapy for post-remission in newly diagnosed dlbcl who are intolerant to first-line intensive chemotherapy.


Eligibility criteria:
inclusion criteria: 1. patients were informed about this study and voluntarily signed written informed consent 2. patients were intolerant first-line intensive chemotherapy, including r-chop or r-da-epoch: a) age≧70 years, or unfit or frail according to cga; b) ecog 0-2; c) measurable lesions 3. dlbcl with initial cr/pr according to 2016 who classification of tumor of haematopoietic and lymphoid tissues 4. life expectancy \> 3 months 5. normal blood count as defined as: absolute neutrophil count ≥1.0 × 10 9 /l independent of growth factor support, platelet count ≥ 100,000/mm 3 or ≥ 50,000/mm 3 if bone marrow (bm) involvement independent of transfusion support in either situation normal organ functions defined as: creatinine ≤1.5 times the upper limit of normal (uln) or estimated glomerular filtration rate (cockroft-gault) ≥50 ml/min/1.73m 2 , aspartate aminotransferase (ast) or alanine aminotransferase (alt) ≤2.5× the uln; total bilirubin ≤ 1.5 × the uln unless bilirubin rise is due to gilbert's syndrome or of non-hepatic origin: patients with documented gilbert disease may be enrolled if total bilirubin is ≤ 3.0 × the uln; 6. women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. - women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[beta-hcg\]) or urine pregnancy test at screening. women who are pregnant or breastfeeding are ineligible for this study. exclusion criteria: 1. contraindication to any drug in the study 2. seropositive for or active viral infection with hbv or hcv 3. human immunodeficiency virus (hiv) infection 4. any grade 3 or 4 heart disease as defined by the new york heart association (nyha) functional class; 5. qtc (corrected by fridericia formula): \>480ms; 6. prior malignancies other than lymphoma in the last 5 years with exception of currently treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix 7. if female, the patient is pregnant or breast-feeding 8. any uncontrolled active systemic infection

Keywords: dlbcl zanubrutinib maintenance
non-inferiority trial comparing eurofarma's experimental product saccharomyces boulardii versus floratil® in the prevention of antibiotic-associated diarrhea

Conditions: Antibiotics

Summary: the study's objective is to evaluate the efficacy and safety of two formulations for the prophylactic treatment of diarrhea in subjects using antibiotics.


Eligibility criteria:
inclusion criteria: 1. icf signature; 2. the subject must agree to follow the instructions and to perform study procedures and visits; 3. male and female subjects between 18 and 65 years old; 4. subjects who have scheduled a treatment or started the use of antibiotics over 24 hours ago: exclusion criteria: 1. generalized infection or bacteremia; 2. chronic gastrointestinal diseases (e.g., crohn's disease and irritable bowel syndrome); 3. documented chronic diarrhea; 4. acute diarrhea episode within 24 hours prior to the start of antibiotic use. use of tube feeding (nasogastric and nasoenteral); 5. immunodeficiency (radiotherapy or chemotherapy); 6. use of food with probiotic properties in the last 10 days;
intensity-modulated radiation therapy in treating patients with prostate cancer

Conditions: Prostate Cancer

Summary: rationale: specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. purpose: this phase i trial is studying the best dose of intensity-modulated radiation therapy in treating patients with prostate cancer.

objectives: * to test the feasibility of delivering hypofractionated intensity-modulated radiotherapy to the prostate and pelvic nodes of patients with prostate cancer. * to determine the optimal dose level of this treatment regimen to be used in future studies. outline: patients are stratified according to small bowel total volume (low small bowel volume \< 450 cc vs high small bowel volume ≥ 450 cc). patients undergo hypofractionated intensity-modulated radiotherapy to the prostate and pelvis for 4 weeks in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed up every 6 months for 5 years and then annually thereafter.

Eligibility criteria:
disease characteristics: * diagnosis of prostate cancer meeting 1 of the following criteria: * stage t3b/t4 disease or radiological or pathological pelvic nodal metastases * localized disease (stage pt2-t4) with \> 30% estimated risk of pelvic nodal metastases * high-risk (gleason score ≥ 8 or ≥ 2 risk factors) or very high-risk disease according to the national collaborative cancer network (nccn) * has undergone prostatectomy and has stage t2-t3a, n0 disease with extensive high-risk disease (gleason score ≥ 8) or seminal vesicle or lymph node involvement * candidate for radical radiotherapy patient characteristics: * no inflammatory bowel disease or other small bowel disease prior concurrent therapy: * no prior pelvic radiotherapy or surgery (excluding prostatectomy)

Keywords: stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer stage iv prostate cancer
a manufacturing transfer study comparing the bioequivalence of a single oral dose of claritin-d 12-hour extended release tablet from 2 different manufactuers under fed conditions in healthy adult subjects

Conditions: Clinical Pharmacology

Summary: to evaluate the bioequivalence of one extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for bayer healthcare llc by sag manufacturing, s.l.u. madrid, spain (test treatment) to the extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for bayer sa-nv by schering- plough labo nv heist (reference treatment) which is currently marketed in europe.


Eligibility criteria:
inclusion criteria: * healthy adult men or women * age 18 to 55 years inclusive * body mass index 18.5 to 30.0 kg/m\*2 inclusive * be willing and able to consume all contents of the standardized breakfast within 30 minutes of dosing exclusion criteria: * positive alcohol or drug screen at screening or on day -1 of each dosing period; * use of within 1 month before first study drug administration, systemic or topical medicines or substances which might affect the study objectives, any drug known to induce cytochrome p3a4/5 or p glycoprotein (e.g., rifampin, carbamazepine, st. john's wort); any drug known to inhibit cytochrome p3a4/5 or p glycoprotein (e.g., clarithromycin, chloramphenicol, ketoconazole); * history of hypersensitivity symptoms with the use of loratadine, desloratadine (clarinex), or pseudoephedrine; * females who are pregnant or lactating * known severe allergies (e.g., allergies to more than 3 allergens, allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids); * more than moderate alcohol consumption (\>40 g of alcohol regularly per day); * any history or suspicion of barbiturate, amphetamine, benzodiazepine, cocaine, opiates, methamphetamine or cannabis abuse; * loss of blood of 50 ml to 499 ml within 30 days of the first dose of trial treatment, or in excess of 500 ml within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis or injury)

Keywords: upper respiratory allergy symptoms including congestion
clinical and biochemical evaluation of the efficacy of non-surgical treatment approaches in the treatment of peri-implantitis

Conditions: Peri-Implantitis

Summary: peri-implantitis is a pathological condition associated with plaque that develops around dental implants, characterized by inflammation and progressive bone loss in the peri-implant area. bleeding on probing, suppuration, increased pathological pocket depths and/or mucosal recessions are seen with radiographic bone loss in peri-implantitis. when evaluated histologically, the lesion extends to the apical part of the pocket epithelium and contains a large amount of plasma cells, macrophages and neutrophils. in the peri-implant crevicular fluid analysis, which is one of the most important parameters that enable the biochemical and immunological evaluation of the inflammatory state in the peri-implant region, information about the current inflammatory situation can be obtained by evaluating the content of an osmotic inflammatory exudate originating from the vessels in the gingival plexus. many surgical and non-surgical methods have been proposed for the treatment of peri-implantitis. mechanical surface debridement, laser application and air abrasives are a part of non-surgical treatment of peri-implantitis. in this study, we examined the effectiveness of diode laser in addition to mechanical debridement with titanium curettes. in our study, we aimed to compare these two treatments biochemically by determining the changes in interleukin-1β, interleukin-10, interleukin-17, rankl, osteoprotegerin, tweak and sclerostin biomarkers in peri-implant crevicular fluid and clinically.

primary outcome measures (probing depth as clinical parameter) and secondary outcome measures ( collection of gingival crevicular fluid, gingival bleeding time index, gingival index, plaque index and clinical attachment level) asre recorded in baseline, third and sixth month. the change between these parameters is observed.

Eligibility criteria:
inclusion criteria: * presence of 5mm or more peri-implant pockets * not having periodontal treatment in the last 3 months, * the informed consent form must be approved, * at least 18 years old. exclusion criteria: * presence of systemic disease, * smoking, * regular use of non-steroidal anti inflammatory drugs, * having been treated with antibiotics in the last 3 months, * individuals in need of pre-treatment antibiotic prophylaxis, * pregnancy and lactation, * not approving the informed consent form, * patients with known allergies.
study of oral osi-027 in patients with advanced solid tumors or lymphoma

Conditions: Any Solid Tumor or Lymphoma

Summary: the primary objective of this study is to determine the maximum tolerated dose (mtd) and to establish the recommended phase 2 dose of oral osi-027 when administered via 3 schedules, namely, intermittent, weekly, and continuous in patients with advanced solid tumors or lymphoma, namely, intermittent, weekly, and continuous.

the study will open with schedule 1 (s1, intermittent) with initiation of schedule 2 (s2, weekly) and schedule 3 (s3, continuous), which may occur in parallel after observation of clinically significant related dose limiting toxicity (dlt) in the s1 schedule. dosing will be initiated on day 1 with intermittent weekly dosing continuing for 21 days (1 treatment period). expansion of dose escalation cohorts may occur for s1 and s2 at the recommended phase 2 dose level(s) and a biomarker expansion cohort may be opened in s1 and/or s2.

Eligibility criteria:
inclusion criteria: * histologically or cytologically documented malignancy (solid tumor or lymphoma) * eastern cooperative oncology group performance status (ecog ps) ≤ 2 * predicted life expectancy of at least 3 months * adequate hematopoietic and hepatic function, and normal renal function * fasting glucose \<7mmol/l at baseline * left ventricular ejection fracture (lvef) by multiple gated acquisition scan (muga)≥ 60% * practice effective contraceptive measures throughout study * verbal and written informed consent * prior therapy: * chemotherapy, minimum of 3 weeks and recovered from any treatment-related toxicities (except for alopecia, and grade 1 neurotoxicity) prior to registration * hormonal, discontinued prior to registration * radiation, minimum of 21 days and recovered from toxic effects prior to registration * surgery, provided wound healing has occurred exclusion criteria: * history of significant cardiac disease unless well controlled * discontinuation from prior therapy due to cardiac toxicity * active or uncontrolled infections * serious illness or medical condition that could interfere with study participation * history of any psychiatric condition that might impair understanding or compliance * documented history of diabetes mellitus * pregnant or breastfeeding females * unstable symptomatic brain metastases, that require steroid or that have required radiation in the last 28 days * chronic systemic steroid use for cancer related condition * history of allergic reactions * patients with cataract who are expected to undergo surgery within 6 months of registration * use of drugs causing qt interval prolongation within 14 days prior to dosing * patients with clinically significant electrolyte imbalances

Keywords: osi-027 solid tumor lymphoma
highlanders with high altitude pulmonary hypertension (haph), 6 minute walk distance (6mwd) assessed at 3200m with and without supplemental oxygen therapy (sot)

Conditions: High Altitude Pulmonary Hypertension

Summary: the investigators aim to study the effect of sot in highlanders with high altitude pulmonary hypertension (haph) who permanently live \>2500m on 6-minute walk distance (6mwd) assessed at 3200m.

highlanders with haph diagnosed by echocardiography and defined by a rv/ra (tricuspid regurgitation pressure gradient) \>30 mmhg will be recruited for this project. highlanders permanently living at ha \>2500 m will perform a 6-minute walk distance test near their living altitude in aksay at 3200 m with and without portable pulsed supplemental oxygen therapy (sot) via nasal cannula according to a randomized cross-over design.

Eligibility criteria:
inclusion criteria: * permanently living \>2500 m * haph diagnosed with a minimum rv/ra of 30 mmhg assessed by echocardiography at an altitude of 3200 m * written informed consent exclusion criteria: * highlanders who cannot follow the study investigations, * patients with moderate to severe concomitant lung disease (fev1\ 20 cigarettes/day or \>20 pack-years. * coexistent unstable systemic hypertension or coronary artery disease that required adjustment of medication within the last 2 months * regular use of medication that affects control of breathing (benzodiazepines, opioids, acetazolamide)

Keywords: pulmonary hypertension hypoxia high altitude supplemental oxygen therapy 6-minute walk test
implementation research to increase colorectal cancer screening rates among low income and ethnic minority groups

Conditions: Colorectal Carcinoma

Summary: this clinical trial implements research strategies to increase colorectal cancer (crc) screening rates among low income and ethnic minority groups. crc is the second most common cause of cancer mortality in the united states and disproportionately burdens low income and ethnic minority groups. fecal immunochemical testing (fit) is a test to check for blood in the stool. a brush is used to collect water drops from around the surface of a stool while it is still in the toilet bowl. the samples are then sent to a laboratory, where they are checked for a human blood protein. blood in the stool may be a sign of colorectal cancer. despite its potential for reducing crc incidence and mortality, screening remains woefully underutilized. there is an unmet need for practical and effective programs to improve crc screening rates. by implementing a culturally-tailored screening crc program that supports providers and clinic staff to encourage eligible patients to complete fit, researchers hope to reduce cancer disparities among low-income and ethnic groups and increase the crc screening rate, which will help providers find crc sooner, when it may be easier to treat.

primary objective: i. to increase crc screening rates within northeast valley health corporation (nevhc). outline: clinic sites are randomized to 1 of 2 groups. group i clinics: physicians and clinic staff receive ongoing training, education, and feedback on crc screening, and utilize point-of-care clinical decision support tool throughout the trial. patients receive crc screening recommendations from provider, a fit kit with culturally tailored instructions, consultation with clinic staff, and text message reminders throughout the trial. group ii clinics: physicians and clinic staff provide and patients receive crc screening usual care throughout the trial.

Eligibility criteria:
inclusion criteria: * patients: 50-75 years of age * patients: \>= 1 clinic visit/past 2 years
comparison of thoracolumbar interfascial and erector spinae plane block on analgesic efficiency of after spinal surgery

Conditions: Postoperative Pain; Postoperative Nausea and Vomiting; Opioid Use

Summary: spinal surgery is typically associated with severe postoperative pain. although the number of spinal surgeries has increased day by day, postoperative pain management have been limited. the recently described thoracolumbar interfacial plane block (tlipb) has been reported to provide effective postoperative analgesia in spinal surgery. in addition, the recently described erector spinae plane block (espb) is obtained by applying the local anesthetic drug between the fascia of the spina muscles and the transverse process of the vertebrae. anatomical and radiological investigations in fresh cadavers suggest that the potential place of influence of espb is dorsal and ventral spinal nerve roots. a small number of publications showing the analgesic efficacy of esp in spinal surgery have been reported in the literature. in this study, the investigators aimed to compare the analgesic efficacy of tlipb and espb in spinal surgeries.


Eligibility criteria:
inclusion criteria: 1. 20-75 years 2. asa 1-2-3 3. patients scheduled for elective surgery exclusion criteria: 1. patients with previous neurological disease symptoms (tia, syncope, dementia, etc.) 2. allergy to drugs 3. major cardiac disease 4. renal failure 5. psychiatric disease 6. patients who refuse to participate in the study 7. chronic back and lower back pain

Keywords: thoracolumbar interfascial block, erector spinae plane block
brief mindfulness for foot and ankle pain

Conditions: Pain

Summary: this is a single-site, four-arm, parallel-group randomized clinical trial (rct). the clinical effects of three different formats of a very brief (i.e., 3 minute), audio-recorded mindfulness intervention for foot and ankle patients will be investigated relative to a 3-minute audio-recoding about pain psychoeducation.


Eligibility criteria:
inclusion criteria: * age ≥18 * seeking foot or ankle treatment at the university orthopaedic center exclusion criteria: * cognitive impairment preventing completion of study procedures. * current cancer diagnosis, * other unstable illness judged by medical staff to interfere with study involvement.
move trial: motivational strategies to empower african americans to improve dialysis adherence

Conditions: End Stage Renal Disease on Dialysis

Summary: move trial is a randomized clinical trial designed to rigorously test the impact of a behavioral intervention (culturally tailored motivational interviewing - (move)) delivered by trained health coaches, on hemodialysis treatment non-adherence. it is a a two-arm, parallel group randomized clinical trial with 24-week follow-up. it involves completion of surveys by patients enrolled in the study. it also involves participation in motivational interviewing sessions by patients who are randomized to the intervention (mi).


Eligibility criteria:
inclusion criteria: * african american * receiving hemodialysis treatments * been on hemodialysis for more than 30 days * 18 years of age and older * within a 2-month look back at the time of screening, patients who have missed at least one dialysis session or shortened at least one dialysis session by 15 minutes. exclusion criteria: * not self-identified as african american * impaired with mental status or severe illness * non-english speaking * no documented evidence of dialysis treatment non-adherence * missed or shortened treatments due to hospitalizations or excused travel * terminal condition * living in a nursing home/rehab * planned transplant within the next 6 months * planned conversion to peritoneal dialysis within the next 6 months

Keywords: dialysis treatment adherence; hemodialysis; african americans