Kornimate/medical-research-clean huggingface dataset:
comparative study of the safety and efficacy of clarithromycin extended-release tablets versus amoxicillin-clavulanate for the treatment of acute bacterial sinusitis

Conditions: Acute Bacterial Sinusitis (ABS)

Summary: to compare the safety/tolerability and efficacy of a 14-day course of clarithromycin extended-release tablets (2 x 500 mg qd) with that of a 14-day course of amoxicillin-clavulanate tablets (875/125 mg bid) for the treatment of ambulatory subjects with acute bacterial sinusitis (abs).


Eligibility criteria:
inclusion criteria: * the female must be non-lactating and at no risk for pregnancy. * subject must have a diagnosis of abs. the diagnosis must be based on the following: * a sinus radiograph (water's view) or ct scan with evidence of maxillary opacification or * air/fluid levels purulent discharge from the nose * at least two of the following additional signs and symptoms lasting longer than seven days prior to and no longer than 28 days before evaluation 1. * a pre-treatment sample from a sinus puncture or * middle meatus endoscopy must be obtained for bacterial aerobic culture * susceptibility testing (applicable only for selected investigative sites). * subject must be a suitable candidate for oral antibiotic therapy and able to swallow tablets intact. exclusion criteria: * a medical history of hypersensitivity or allergic reactions to clarithromycin, erythromycin, amoxicillin/clavulanate, any penicillin or any of the macrolide antibiotics. * history of amoxicillin-clavulanate associated cholestatic jaundicehepatic dysfunction. * females who are pregnant or lactating. * subject has either of the following: * chronic sinusitis (signs and symptoms lasting longer than 28 days immediately prior to evaluation 1) * significant anatomical abnormalities of the sinuses any other infection or * condition which necessitates use of a concomitant systemic antibiotic. * evidence of uncontrolled clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, psychiatric or endocrine disease, malignancy, or other abnormality (other than the disease being studied). * any underlying condition/disease, that would be likely to interfere with the completion of the course of study drug therapy or follow-up. * known significant renal or hepatic impairment (or disease). * subject who has taken: a systemic antibiotic within 2 weeks before study drug administration or a long-acting injectable antibiotic (e.g., penicillin g benzathine) within 4 weeks before study drug administration. * immunocompromised subjects (e.g., neutropenic subjects). * subjects with known hiv infection. * treatment with any other investigational drug within 4 weeks prior to study drug administration.
mechanism and immune function analysis of sars-cov-2 infection in hematologic tumors

Conditions: SARS-CoV-2 Infection; Hematologic Malignancy

Summary: the goal of this observational study is to compare the immune function and infection mechanism of patients with hematologic tumors and those people without underlying diseases after infection with sars-cov-2. clinical characteristics, treatment options and responses will be collected. peripheral blood will be collected from patients with hematologic tumors infected with sars-cov-2 and those people without underlying diseases infected with sars-cov-2.

to establish a retrospective and prospective cohort of patients with hematologic tumors infected with sars-cov-2 and people without underlying diseases infected with sars-cov-2. firstly, peripheral blood samples will be collected at infection time points and after sars-cov-2 nucleic acid testing turns negative. subsequently, the transcriptome sequencing and immunological experiments will be performed to analyze the differentially expressed genes, immune function of cells, etc. comparative analysis: 1. to compare the immune function of patients with hematologic tumors and those without underlying diseases after infection with sars-cov-2. 2. the transcriptomic and proteomic changes of patients with hematologic tumors are compared with those without underlying diseases after infection with sars-cov-2. 3. from the perspective of complex (human protein interaction subnetwork), the dynamic change process of sars-cov-2-targeted human protein complex (periodic complex) was deeply explored, in order to further analyze its potential dynamic infection mechanism and provide new clues for the discovery of drug targets.

Eligibility criteria:
inclusion criteria: - clinical diagnosis of hematologic tumors clinical diagnosis of sars-cov-2 infection exclusion criteria: - severe diseases associated with other systems

Keywords: sars-cov-2 infection hematologic malignancy leukemia interaction immune function network analysis
plasma biomarker in predicting response and toxicity in hcc patients treated with checkpoint inhibitors with or without sbrt

Conditions: Hepatocellular Carcinoma Non-resectable; Stereotactic Body Radiotherapy

Summary: this is a prospective study to investigate the biomarkers in predicting treatment outcome and toxicity in hepatocellular carcinoma (hcc) patients receiving immune checkpoint inhibitors with or without stereotactic body radiotherapy (sbrt).


Eligibility criteria:
inclusion criteria: first cohort (sbrt+io): 1. unresectable hcc confirmed by multi-disciplinary team 2. tumor size 5-15cm 3. number of lesion(s) ≤ 3 4. no main portal vein or inferior vena cava thrombosis 5. ecog performance status 0-1 6. child-pugh class a-b7 7. liver volume minus gross tumor volume \> 700ml 8. adequate organ function 9. no prior systemic therapy, immunotherapy, tace, radiotherapy, or radio-embolization second cohort (io alone): 1. bclc stage c hcc 2. ecog performance status 0-1 3. child-pugh class a5-b9 4. adequate organ function exclusion criteria: 1. based on the inclusion criteria above. any eligibility factors that do not fit the inclusion criteria will be considered as ineligible subjects.

Keywords: sbrt immune checkpoint inhibitors
quality improvement of patient-provider communication for colorectal cancer screening

Conditions: Colorectal Cancer

Summary: the immediate objective of this proposal is to assess the effectiveness of a multi-faceted intervention to improve patient-provider communication about colorectal cancer screening in improving patient adherence with colorectal cancer screening recommendations. this intervention consists of: (1) guiding the communication process through patient activation to initiate a colorectal cancer screening discussion; (2) optimizing communication content through the use of a prompt sheet; and (3) cueing the provider to assess patient perception of the communication. the long-term objective of our research program is to maximize colorectal cancer screening rates throughout the va through widespread adoption of clinically feasible approaches to enhance patient-provider communication.

in the united states, colorectal cancer is the third most common cancer and the second leading cause of cancer mortality with over 56,000 deaths in 2004). early detection through screening decreases the mortality associated with the disease. however, adherence with current screening recommendations is low. a survey of the general population indicates that only 53.1% of americans, age 50 years and older for whom colorectal cancer screening is recommended, are up-to-date with this preventive service. while colorectal cancer screening rates with the va healthcare system (vha) are better than in the general population (75% in fiscal year (fy) 2005), they are lower than performance rates for other types of cancer screening (e.g., mammography) in vha. further, numerous va medical centers report colorectal cancer screening rates below the level considered satisfactory.

Eligibility criteria:
inclusion criteria: provider eligibility: * primary care providers (md, certified registered nurse practitioner (crnp), or pa) at the study sites who see patients in the primary care setting at least 1 day per week and had no involvement in the design of the study are eligible for enrollment in the study. patient eligibility: * primary care patients who are not "up-to-date" with colorectal cancer screening are the targeted population for study enrollment. * up-to-date with colorectal cancer screening is defined as having completed one of the following: * fecal occult blood testing within the past year * sigmoidoscopy within the past 5 years * colonoscopy within the past 10 years * barium enema within the past 5 years. * other patient eligibility criteria are: * primary care provider (pcp) enrolled in the study * clinic visit scheduled with the enrolled pcp during the recruitment period * english speaking * no prior history of colorectal cancer or adenomatous polyps * no prior history of inflammatory bowel disease exclusion criteria: * patients who are deemed clinically not appropriate for colorectal cancer screening due to severe comorbidity and/or limited life expectancy as determined by the patient's primary care provider will be excluded from the study.

Keywords: cancer screening communication prevention
short-course radiotherapy combined with capox and pd-1 antibody versus long-course chemoradiotherapy combined with capox for early low-lying rectal cancer

Conditions: Early Low Rectal Cancer

Summary: torch-e2 is a prospective, multicentre, randomized phase ii trial. 134 low-lying early (t1-3b/n0-1m0, distance from anal verge ≤5cm) patients will be recruited and assigned to group 1 and group 2 (1:1). group 1 receives scrt (25gy/5fx) followed by 4 cycles of capecitabine plus oxaliplatin (capox) chemotherapy and pd-1 antibody. group 2 receives lcrt (50gy/25fx) followed by 2 cycles of capox. a ww option can be applied to patients achieving ccr while surgery will be recommended for those who fail to achieve ccr. the primary endpoint is complete response (cr, pathological complete response \[pcr\] plus ccr) rate. the secondary endpoints include the grade 3-4 acute adverse effects (ae) rate, anal preservation rate, 3-year dfs rate, etc.


Eligibility criteria:
inclusion criteria: 1. age 18-75 years old, female and male 2. pathological confirmed adenocarcinoma 3. clinical stage t1-3bn0-1, tumor maximum diameter less than 4cm 4. the distance from anal verge less than 5 cm 5. without distance metastases 6. kps \>=70 7. with good compliance 8. microsatellite repair status is mss/pmmr 9. without previous anti-cancer therapy or immunotherapy 10. signed the inform consent exclusion criteria: 1. pregnancy or breast-feeding women 2. pathological confirmed signet ring cell carcinoma 3. clinical stage t1n0 and can be resected locally 4. history of other malignancies within 5 years 5. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc. 6. immunodeficiency disease or long-term using of immunosuppressive agents 7. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/l, hb≥90g/l, plt≥100×10\^9/l, alt/ast ≤2.5 uln, cr≤ 1 uln 8. dpd deficiency 9. allergic to any component of the therapy
phosphodiesterase 5 inhibitors (pde5i) (sildenafil) as medical expulsive therapy in distal ureteral stones

Conditions: Ureteral Stone; Urolithiasis

Summary: urolithiasis is one of the most common urological diseases. the risk of urolithiasis is estimated to be between 5% and 12% all over the world with increased incidence in male rather than female (2:1) respectively . ureteral stones account for 20% from all urinary tract stones, more than 70% of the ureteral stones found in the lower third of the ureter . the incidence of urinary stones has been increasing day by day. medical expulsive therapy (met) of ureteral stones is the investigators' concern in this study. stone location, size, number, ureteral spasm, mucosal edema or inflammation and ureteral anatomy are the factors affecting passage of the ureteral stones. so, met is based on mechanism that stone passage is facilitated by the relaxation of ureteral smooth muscle , increasing hydrostatic pressure proximal to the stone and decreasing exciting edema . there are many oral medication could be used as met such as adrenergic blockers, calcium channel blockers, prostaglandin synthesis inhibitors, glyceryl trinitrate and steroid treatment . calcium-channel blockers and adrenergic α-antagonists are the main that has been proposed to enhance stone passage as expulsive medical therapy. cyclic nucleotides are degraded by phosphodiesterases enzymes (pdes). so using of pde inhibtors may play role in relaxation of smooth muscle of the ureter. a study was done for evaluation of three pde5 inhibtors, sildenafil , vardenafil and tadalafil, they found that pde5 inhibitors can reverse the tension of isolated human ureteral smooth muscle via cgmp-mediated pathways.


Eligibility criteria:
inclusion criteria: 1. male patient aged from 18-65 years. 2. lower third ureteric stones at or below sacro-iliac joint . 3. stone size rang from 5- 10 mm. 4. unilateral ureteric stone exclusion criteria: 1. patients who had recurrent fever. 2. patient underwent eswl. 3. patient with rising serum creatinine \> 2mg/dl. 4. patient with history of uretero-vesical reimplantation. 5. stone larger than 10 mm

Keywords: phosphodiesterase 5 inhibitors pde5i sildinafil
study to evaluate the safety, tolerability, and efficacy of asc41 tablets in adult patients with nash

Conditions: Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis

Summary: this is a phase 2, double-blind, randomized, multicenter, placebo-controlled study to evaluate the safety, tolerability, and efficacy of asc41 in adults with nonalcoholic steatohepatitis (nash).


Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤ 80 years old at screening. * presence of ≥ 7.5% steatosis on screening mri-pdff read centrally by a radiologist and performed either during the screening period or within 6 months prior to the first visit. * hba1c ≤ 9.5%. * normal or minimally abnormal renal function as defined by estimated glomerular filtration rate (egfr) ≥ 50 ml/min/1.73 m\^2 exclusion criteria: * presence or history of cirrhosis or evidence of decompensated liver disease (e.g., ascites, variceal bleeding) or hepatocellular carcinoma. * history or presence of other concomitant liver disease as assessed by the investigator or determined by laboratory findings. * uncontrolled type 2 diabetes mellitus (t2dm) defined as hba1c of \> 9.5% within 60 days prior to enrollment. * change in anti-diabetic therapy within 6 months prior to qualifying liver biopsy.

Keywords: non-alcoholic fatty liver disease nash asc41 phase ii thr-β
off-script diagnosis & differential diagnosis (d&d) training and residents' stroke knowledge

Conditions: Stroke, Acute; Educational Problems; Clinical Course

Summary: this study is a single-center, randomized, open-label, controlled, endpoint-blinded study to assess the effect of off-script diagnosis \& differential diagnosis (d\&d) training in improving the residents' knowledge of acute ischemic stroke in china. the investigators will enroll 22 residents and assess the score of masmaq 30 days after randomization.

ischemic stroke is characterized by high incidence and disability rates, with a critical time window for reperfusion therapy, necessitating prompt recognition, diagnosis, and treatment by frontline physicians. in clinical practice, residents across all specialties may encounter acute ischemic stroke (ais) patients in emergency departments, outpatient clinics, or inpatient wards. however, many residents face challenges in managing ais cases, often leading to missed diagnoses, treatment delays, and non-adherence to clinical guidelines. a primary contributing factor is their insufficient mastery of key ais management principles and inability to effectively apply stroke knowledge in clinical contexts. enhancing residents' ais management competence represents a significant challenge in stroke education. traditional "initial progress note" training overemphasizes comprehensive differential diagnoses, with most residents relying on scripted presentations. the actual clinical application of stroke knowledge remains uncertain. this study aims to evaluate whether off-script diagnosis \& differential diagnosis (d\&d) training (i.e., "structured off-script d\&d") can significantly improve residents' ais management knowledge. the investigators will enroll 22 neurology residents and randomly assign them to two groups: the off-script diagnosis \& differential diagnosis (d\&d) training group (n=11) and a blank control group (n=11). the modified acute stroke management questionnaire (masmaq) will be used to assess residents' ais knowledge 30 days after randomization.

Eligibility criteria:
inclusion criteria: 1. residents (physicians in postgraduate training). 2. currently in neurology wards 3. managing acute ischemic stroke (ais) patients, defined as: 1)time from onset to randomization ≤ 2 weeks; 2) if onset time is unknown, the last known well time is considered the onset time. 4. signed informed consent exclusion criteria: 1. managing asymptomatic ischemic stroke patients. 2. residents who are currently participating or have participated in another interventional ischemic stroke training program within the past 3 months.

Keywords: resident stroke education
closure after total shoulder arthroplasty: prineo vs dermabond

Conditions: Shoulder Arthritis; Shoulder Arthropathy Associated With Other Conditions

Summary: the objective is to compare two types of wound closure after total shoulder arthroplasty to determine which closure is faster, and subsequently if there are different outcomes between the two types of closures. the objective of this study is to compare two types of wound closure after total shoulder arthroplasty procedures. a single fellowship trained shoulder surgeon will perform all procedures. it is hypothesized that participants who undergo an 2-octyl cyanoacrylate (oca) mesh closure will have a faster closure time, lower cost, non-inferior complication rate, and non-inferior satisfaction scores with respect postoperative follow up and scar appearance. participants in the oca mesh cohort will be compared to participants who have a closure with a running monocryl suture and dermabond. this investigation seeks to determine if oca closure mesh closure is non-inferior to monocryl suture and dermabond in terms of operative time, cost, complications, and aesthetic appearance. if the hypothesis is confirmed, this study will suggest that a oca mesh closure may be used for total shoulder arthroplasty surgeries as an alternative to current conventional closures and may provide a cost benefit.


Eligibility criteria:
inclusion criteria: * total shoulder arthroplasty * reverse total shoulder arthroplasty * age 18-100 * single surgeon exclusion criteria: * previous shoulder surgery * known wound healing complications * dm, chronic steroid use, vascular insufficiency, morbid obesity (bmi\>40), esrd, family hx of pathologic scars * patients on blood thinners (asa 81mg ok) * connective tissue disease * allergy to skin adhesive * mentally unable to complete questionnaires * previous wound over planned incision

Keywords: prino total shoulder arthroplasty wound closure
development, acceptability and preliminary efficacy of an internet-based self-help program

Conditions: Burnout, Professional

Summary: this study aims to evaluate acceptability and initial effectiveness of an internet-based self-help program utilizing acceptance and commitment therapy specifically for healthcare workers, intending to address burnout.

this pilot study is a randomized controlled trial of two parallel groups. the study will comprise of an intervention and a wait-list control group. the intention of this study is to evaluate the acceptability and preliminary efficacy of an internet-based self-help program with minimal telephone support utilizing acceptance and commitment therapy for alleviating burnout among healthcare workers.

Eligibility criteria:
inclusion criteria: * currently employed in the healthcare field as a doctor, nurse, technician, pharmacist or other healthcare profession for a minimum of six months. * proficiency in using computer and email. * experiencing symptoms of burnout related to the workplace. exclusion criteria: * currently prescribed psychotropic medication. * currently undergoing psychotherapy. * presently experiencing thoughts of suicide or self-mutilation.

Keywords: burnout acceptance and commitment therapy web-based intervention healthcare workers
a randomized, double-blind, placebo-controlled, combined single ascending dose and multiple ascending dose study

Conditions: Alzheimer's Disease

Summary: the purpose of this study will be to evaluate the safety and tolerability of lecanemab at sequentially ascending doses in subjects with mild to moderate alzheimer's disease (ad).

this will be a multicenter, double-blind, randomized, placebo-controlled study in subjects with mild to moderate alzheimer's disease. the study will comprise separate single dose ascending (sad) and multiple dose ascending (mad) parts designed to allow the mad part to be initiated while the sad part is ongoing.

Eligibility criteria:
inclusion: 1. clinical diagnosis of probable mild to moderate alzheimer's disease (ad) by national institute of neurological and communicative disorders and stroke and the alzheimer's disease and related disorders association alzheimer's (nincds-adrda) criteria. 2. a mini mental state examination (mmse) score of 16 to 28, inclusive, at screening. subjects recruited to the first 2 sad cohorts should have an mmse of \> 22. 3. where symptomatic treatment of alzheimer's disease (ad) is clinically indicated, subjects must be on stable treatment (e.g., with an anticholinesterase inhibitor \[achei\] and/or memantine) for at least 12 weeks prior to the screening visit. 4. on stable doses of all other prescribed medications for at least 4 weeks prior to the screening visit. exclusion: 1. any neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's alzheimer's disease (ad). 2. any psychiatric diagnosis or symptoms, e.g hallucinations, major depression, or delusions, that could interfere with assessment of cognition in the subject. 3. history of transient ischemic attack (tia), stroke, or seizures within 12 months of screening. 4. evidence of infection, tumor, stroke or other clinically significant lesions that could indicate a dementia diagnosis other than ad on brain magnetic resonance imaging (mri) at screening. 5. other significant pathological findings on brain mri at screening, including but not limited to: more than 3 micro-hemorrhages, single macro-hemorrhage; evidence of vasogenic edema; evidence of cerebral contusion, encephalomalacia, aneurysms, vascular malformations or space occupying lesions.