Kornimate/medical-research-clean huggingface dataset:
urea cream prevention for capecitabine associated hand foot syndrome

Conditions: Hand-Foot Syndrome

Summary: hand foot skin reaction (hfs) from capecitabine is one of the most common adverse events from capecitabine. urea cream has been proved its benefit to prevent hfs from sorafenib. prior study using urea cream prophylaxis in patients receiving capecitabine was negative. however, result from aformentioned study was reported primarily from result of first cycle capecitabine. urea cream as a prevention of hfs from capecitabine has been used in clinical practice in thailand according to expert's opinion. we conducted the study to evaluate wheter the urea cream can prevent hfs or severe hfs.

the patients who is planned to receive capecitabine for at least 3 cycles were enrolled in the study. the patients were randomized to receive 10% urea cream or standard measure. the patients were followed until the end of capecitabine treatment. the patients reported their symptoms of hfs and other adverse events (ae) before starting new cycle of capecitabine. physician record of hfs and other ae, dose modification of capecitabine and compliance were extracted. we will report incidence of any hfs, \> grade 3 hfs, capecitabine interruption or delay or discontinuation and time to develop hfs among both arms. the results of the study will be used for optimal prophylactic measures in patients treated with capecitabine.

Eligibility criteria:
inclusion criteria: - patients who has plan to receive capecitabine at the dosage of at least 2000 mg/m2 d1-14 every 21 days for at least 3 cycles exclusion criteria: * preexisting neuropathy which was severe than grade 2 * history of allergy to urea cream * patients with previous use of capecitabine 2000 mg/m2 * patients who has prior routinely used of urea cream

Keywords: hand foot syndrome capecitabine urea cream
the treatment of recurrent abdominal pain in children

Conditions: Recurrent Abdominal Pain

Summary: the purpose of this study is to determine if two treatments, a biofeedback and behavioral protocol, for recurrent abdominal pain are equally effective.

recurrent abdominal pain (rap) is a functional disorder that affects approximately 10 to 25% of children in the united states. this population tends to be heavy medical users in a search of a treatment for the chronic pain, but at this time there is no standard treatment protocol. the literature proposes that there are two effective treatments for rap, a relaxation protocol by sanders et al. (1994) and a biofeedback protocol currently in use at kaiser, but neither treatment has been widely accepted as standard treatment. a purpose of this study is to gather more data on both treatments to help move one or both treatments into the standard of care for rap. the hypothesis of this study is that the biofeedback and the relaxation protocols will have equivalent treatment outcomes.

Eligibility criteria:
inclusion criteria: * who speak english * diagnosis with recurrent abdominal pain exclusion criteria: * lactose intolerance, urinary tract infections, or recent head trauma; * the use of prescribed or over he counter medications, which may interfere with the biofeedback data; * currently receiving other treatment for recurrent abdominal pain; * the receipt of a recent and related surgical procedure; * children who met criteria for depression or anxiety disorder

Keywords: recurrent abdominal pain biofeedback heart rate variability
trial of daily pulse interleukin-2 with famotidine in acute myelogenous leukemia

Conditions: Acute Myelogenous Leukemia

Summary: assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment during lymphocyte recovery.

upon lymphocyte recovery after myeloablative induction standard chemotherapy pulse interleukin-2 administered

Eligibility criteria:
inclusion criteria: * confirmed hematopathology diagnosis of aml receiving marrow suppressive treatment * total wbc recovery of 500 mm3 prior to il-2 treatment * platelet count of at least 20,000 mm3 prior to starting il-2 treatment * active infection controlled prior to starting il-2 treatment * stable systolic blood pressure \> 90mm hg prior to starting il-2 treatment * o2 saturation \>90% prior to starting treatment * stable cardiopulmonary status prior to starting il-2 treatment * serum creatinine \< or equal to 2.0 mg/dl * total bilirubin and ast \<3x upper limits normal exclusion criteria: * acute promyelocytic leukemia * active thrombocytopenic bleeding * cardiac ejection fraction below 45% * pregnancy and/or lactation

Keywords: acute myelogenous leukemia interleukin-2
a real-world study in participants with smoldering multiple myeloma

Conditions: Smoldering Multiple Myeloma

Summary: the purpose of this study is to evaluate the real-world characteristics and outcomes of participants with smoldering multiple myeloma (smm) overall and by high-risk and non-high-risk smm according to (aquila study criteria \[nct03301220\], mayo 20-2-20 and international myeloma working group (imwg) 2020 risk classification models), and to evaluate the risk of progressing of smm to multiple myeloma (mm) and outcomes in participants after progressing to mm.


Eligibility criteria:
inclusion criteria: * have a documented diagnosis of smoldering multiple myeloma (smm). smm is defined as: (a) clonal bone marrow plasma cells (bmpcs) greater than or equal to (\>=) 10 percent (%) and/or serum m-protein \>= 3 grams per deciliter (g/dl) and/or urine m-protein \>= 500 milligram per 24 hours (mg/24hrs). (b) absence of slim-crab criteria: \>= 60 % clonal bmpcs, involved/uninvolved free light chain (flc) ratio \>= 100 and involved flc \>= 10 and magnetic resonance imaging (mri) lesions; calcium elevation, renal insufficiency, anemia, and bone lesions (ab) criteria * informed consent obtained prior to retrospective data collection in accordance with local requirements, either an informed consent form (icf) indicating that the participants signed a consent for data collection for this research and agrees to have their data collected and analyzed, with source data verification (sdv), or the country does accept the icf waiver for such type of studies * data recorded in participants' medical charts from date of smm diagnosis and at least 2 years after should be available in the participant's medical chart at the participating site. however, participants who died within the 2 years from smm diagnosis are eligible exclusion criteria: * therapy for multiple myeloma (mm) initiated within 90 days of smm diagnosis * date of smm diagnosis is missing * participants who have participated/are participating in any smm interventional (either active treatment or control arm) study are not eligible. participation in observational studies is allowed. participants who have participated/are participating in any mm study after evolution to mm are eligible
famitinib in combination with camrelizumab and tpc in the first-line treatment of immunomodulatory locally advanced or metastatic tnbc.

Conditions: Triple-Negative Breast Cancer

Summary: the study is being conducted to evaluate the famitinib with camrelizumab plus treatment of physician's choice (tpc) versus camrelizumab plus tpc in patients with unresectable locally advanced or metastatic immunomodulatory triple negative breast cancer.


Eligibility criteria:
inclusion criteria: * ecog performance status of 0-1 * expected lifetime of not less than three months * metastatic or locally advanced, histologically documented tnbc (absence of her2, er, and pr expression) * cancer stage: recurrent or metastatic breast cancer; local recurrence be confirmed by the researchers could not be radical resection. * adequate hematologic and end-organ function, laboratory test results. * measurable disease according to response evaluation criteria in solid tumors v1.1 (recist v1.1) • patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer exclusion criteria: * previous received anti-vegfr small molecule tyrosine kinase inhibitors (e.g. famitinib, sorafenib, sunitinib, regorafenib, etc.) for treatment of the patients . * a history of bleeding, any serious bleeding events. * important blood vessels around tumors has been infringed and high risk of bleeding. * coagulant function abnormality * artery/venous thromboembolism event * history of autoimmune disease * positive test for human immunodeficiency virus * active hepatitis b or hepatitis c * uncontrolled pleural effusion and ascites • known central nervous system (cns) disease. * long-term unhealing wound or incomplete healing of fracture * urine protein ≥2+ and 24h urine protein quantitative \> 1 g. * pregnancy or lactation. * thyroid dysfunction. * peripheral neuropathy grade ≥2. * people with high blood pressure; * a history of unstable angina; * new diagnosis of angina pectoris. * myocardial infarction incident .
svf therapy for human knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of the study is to asses the safety and efficacy of svf for treatment of knee osteoarthritis, and establish a novel method to provide 3d mri imaging for human knee cartilage to qualitatively and quantitatively evaluate cartilage regeneration.

study participants voluntarily provided written informed consent to participate in the study. the two knees of each patient were randomly assigned to autologous svf treatment group or non-treatment control group. the patients were evaluated every 4 weeks for safety and efficacy of autologous svf therapy for 24 weeks.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of knee osteoarthritis * articular cartilage defect grades i/ii of both knee exclusion criteria: * autoimmune or inflammatory arthritis * serious medical disorders

Keywords: cartilage defect cartilage regeneration
innovative cognitive impairment case finding and engagement for diverse participation in alzheimer's disease care, treatment, and research

Conditions: Mild Cognitive Impairment (MCI); Alzheimer Disease; Alzheimer's Disease (Incl Subtypes); Dementia; Cognitive Decline

Summary: recent studies have highlighted the potential use of electronic health record (ehr) data for scalable and less biased identification of people who may have or be at risk of developing mci or adrd at the population level.8,9 using data from the ehr in advance of pc visits can systematically identify patients with undetected mci and adrd. at indiana university (iu), researchers developed a passive digital marker (pdm) to enable early detection of adrd with an 80% accuracy for one-year and three-year prediction horizons.8,9 despite the accuracy of the pdm, the feasibility, acceptability, and overall effectiveness of its use for early detection of adrd in pc remains unclear. building on this innovative tool and the ongoing engagement in iuh pc for early detection of adrd, we propose a project to test the acceptability and feasibility of implementing the pdm in iuh pc to identify people with and at risk of mci and adrd and measure if we can increase patient engagement in research and evidence-based follow-up care with the iuh brain health navigator (bhn). the bhn, is primary care based registered nurse with special training to conduct additional assessments of patients following a positive adrd screen to identify possible underlying causes of cognitive impairment and assist the pcp to facilitate the patient's next steps for diagnostic assessment.


Eligibility criteria:
inclusion criteria: * 65 years and older; established patients of 12 selected clinics at iu health pc who are identified by the pdm as high risk for developing or having undetected mci or adrd. exclusion criteria: * patients younger than 65 years; new patients to iuh (less than 12 months); individuals whose primary language is neither english nor spanish; and current diagnosis of adrd or mci.

Keywords: brain health navigator passive digital marker (pdm) early detection mci alzheimer's disease
neuromodulation to regulate inflammation and autonomic imbalance in sepsis

Conditions: Septic Shock

Summary: sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. it is the most expensive healthcare condition to treat in united states and has a mortality rate of nearly 30%. it is widely known that exaggerated inflammation and imbalance between sympathetic and parasympathetic arms of the autonomic nervous system (ans) contribute to progression and adverse outcomes in sepsis. the role of unchecked inflammation and unregulated ans as a potential treatment target is an important gap in our knowledge that should be explored. cholinergic anti-inflammatory pathway (cap) is an intricate network where the ans senses inflammation by vagus nerve afferents and tries to regulate it by vagus nerve efferents to the reticuloendothelial system. the central hypothesis of this pilot clinical trial is that transcutaneous vagus nerve stimulation (tvns) at tragus of the external ear can activate the cap to suppress inflammation and improve autonomic imbalance as measured by inflammatory cytokine levels and heart rate variability (hrv) analysis. the investigators plan to randomize patients with septic shock into active and sham stimulation groups and study the effects of vagal stimulation on inflammatory cytokines, hrv and a clinical severity score of sepsis. both groups will continue to receive the standard of care treatment for sepsis irrespective of group assignments. the investigators hypothesize that 4 hours of tvns will suppress inflammatory markers and improve the balance between sympathetic and parasympathetic arms of ans as measured by hrv, resulting in improved sequential organ failure assessment score (sofa). the preliminary data generated from this pilot study will lay the foundation for a larger clinical trial.


Eligibility criteria:
inclusion criteria: septic shock (meeting severe sepsis and having persistent systolic blood pressure \<90mmhg despite adequate fluid resuscitation). exclusion criteria: * unilateral or bilateral vagotomy * history of myocardial infarction or stroke in the last 1 year * recurrent vasovagal syncope * sick sinus syndrome without pacemaker * bifascicular heart block * 2nd or 3rd-degree heart block * hypotension due to autonomic dysfunction * pregnant women * prisoners and patients with suicidal ideation

Keywords: sepsis
evaluation of the tympanostomy tube delivery system

Conditions: Otitis Media With Effusion; Acute Otitis Media

Summary: the purpose of this study is to evaluate the performance and safety of the tympanostomy tube delivery system (ttds) for chronic otitis media or recurrent acute otitis media.


Eligibility criteria:
inclusion criteria: * diagnosed with either chronic otitis media with effusion or acute otitis media and scheduled to undergo tympanostomy tube insertion exclusion criteria: * reaction to anesthesia * markedly atrophic, bimeric, severely retracted, atelectatic or perforated tympanic membrane * otitis externa * active acute otitis media * otitis media pathology requiring t-tubes * stenosed ear canal * anatomy that precludes visualization and access to tympanic membrane * anatomy that necessitates tympanostomy tube placement in posterior half of membrane
fecal transplant, a hope to eradicate colonization of patient harboring extreme drug resistant bacteria?

Conditions: Microbial Colonization; Bacterial Peritonitis; Faeces Smearing

Summary: our trial try to eradicate digestive tract colonization of patient harboring extreme drug resistant (xdr) bacteria by performing a fecal transplantation.

main objective: evaluate the eradication of the colonization of patient harboring xdr bacteria after a fecal transplantation from a healthy donor. secondary objectives: english evaluate the side effects of this procedure and tolerability. evaluate the efficacy of the transplant if the patient is harboring glycopeptid resistant enteroccus (gre) or carbapenem resistant enterobacteriae (cre)

Eligibility criteria:
inclusion criteria: * patient harboring a vre or cre bacteria * colonization confirmed by our microbiology department, including at least 3 positives swabs in the last month exclusion criteria: * pregnant woman or breastfeeding * immunosuppression including aids, corticosteroids over 60mg/day * ongoing antibiotic treatment at the day of inclusion * impossibility to obtain a signed consent form.

Keywords: xdr fecal microbiota transplant eradicate colonization cre gre bacteria
transcutaneous monitoring of oxygen and carbon dioxide in surgical patients

Conditions: Transcutaneous Monitoring; Microcirculation; Peripheral Perfusion; Tissue Metabolism

Summary: the study will investigate if non-invasive continuous transcutaneous blood gas monitoring can detect tissue perfusion and hypoxemia and the relation to other circulatory parameters such as pulse, blood pressure, cardiac output and arterial saturation.

macro circulatory parameters such as cardiac output, mean arterial pressure and arterial oxygen saturation are used to monitor the hemodynamic function and tissue perfusion in surgical patients. though none of the methods are directly monitoring changes in the metabolism of the tissue. arterial blood gas analysis is used as the golden standard for the detection of metabolic disturbances before, during and after surgery. disadvantages of the method are 1) the fact that the technique is invasive to the patient, 2) that the method measures the "total gas" (each tissue's contribution to the blood gas in the total circulating blood) and 3) that the methods only provide a snapshot of the patient's blood gas status. transcutaneous monitoring can be used as a continuous monitoring of the underlying tissue's carbon dioxide and oxygen levels in patients. the method is already used in neonates as a surrogate for the arterial blood gas analysis. reduced tissue oxygenation due to inadequate perfusion, will initiate an anaerobic tissue metabolism resulting in low oxygen levels and high carbon dioxide levels. the transcutaneous monitoring can therefore potentially be used to detect tissue hypoxia and become a direct measurement of the underlying tissue metabolism.

Eligibility criteria:
inclusion criteria: * patients undergoing surgery for abdominal cancer * patients undergoing femoral endarterectomy exclusion criteria: * patients not able to give a informed consent
evaluation of effectiveness and safety of biomatrix stent (iris-biomatrix)

Conditions: Coronary Artery Disease

Summary: the objective of this study is to evaluate effectiveness and safety of biomatrix stent in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus- or paclitaxel-eluting stents).

this study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of biomatrix stents versus first-generation drug-eluting stent (des) in patients with coronary artery disease.

Eligibility criteria:
inclusion criteria: * patients receiving biomatrix stents * the patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethics committee of the respective clinical site. exclusion criteria: * patients with a mixture of other dess * terminal illness with life expectancy \<1 year * patients with cardiogenic shock

Keywords: coronary artery disease requiring drug eluting stents
prostate diffusion imaging with distortion correction

Conditions: Prostate Cancer

Summary: there has been literature demonstrating the effectiveness of correcting these mri images by using an additional measurement of the magnetic field, but the implied improvement in lesion detection in these common distorted regions in the prostate has yet to be shown. we propose that introducing this distortion correction would greatly improve the dwi images used for tumour detection. for this study we propose testing this hypothesis as a primary objective, and as a secondary objective including additional b-values to further refine the adc value. the study involves adding one additional distortion correcting scan to the standard clinical study, adding approximately 2 minutes to the study.


Eligibility criteria:
inclusion criteria: * male * aged 18 and over * no contraindication to mr scanning * smokers and non-smokers * patients who have had a complete scan on the 3t scan mri at norfolk and norwich university hospital and have gone on to have a biopsy at the norfolk and norwich university hospital exclusion criteria: * previous diagnosis of prostate cancer, prostatic biopsy or treatment for prostate cancer
incisional negative pressure wound therapy for resection of soft tissue tumors

Conditions: Soft Tissue Sarcoma; Lipoma; Tumor

Summary: this study is aimed to examine the value of incisional negative pressure therapy after resection of soft tissue tumors. its a prospective randomized trial comparing incisional negative pressure to standard wound dressings.

wound healing after resection of large soft tissue tumors is often impaired by large dead space and fluid collection, potentially resulting in seroma formation and infection. aim of the study is to compare negative pressure wound therapy to standard wound dressing in terms of quantity of drainage fluid and wound healing complications.

Eligibility criteria:
inclusion criteria: * soft tissue tumor of extremities or trunk with expected resection of \>10cm tissue in any dimension. exclusion criteria: * no primary skin closure. * skin infection in area of operation (e.g. acne inversa).
a comparison of manufacturing processes for air optix® colors contact lens

Conditions: Myopia

Summary: the purpose of this feasibility study was to compare air optix® colors contact lenses manufactured using an automated process to air optix® colors contact lenses manufactured using a semi-automatic process.


Eligibility criteria:
inclusion criteria: * able and willing to sign a written informed consent form. * cylinder ≤ -0.75 diopter (d). * able to achieve visual acuity (va) of at least 20/30 snellen in each eye at distance with contact lenses (clcva) and best corrected visual acuity (bcva) ≥ 20/25. * have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses. * successful daily wear of single-vision spherical soft contact lenses in both eyes during the past 3 months for a minimum of 8 hours/day, 5 days/week. * other protocol-defined inclusion criteria may apply. exclusion criteria: * eye injury or surgery within twelve weeks immediately prior to enrollment in this trial. * pre-existing ocular irritation that would preclude contact lens fitting. * currently enrolled in an ophthalmic clinical trial. * evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions, as determined by the investigator. * pathologically dry eye. * other protocol-defined exclusion criteria may apply.

Keywords: myopia