Kornimate/medical-research-clean huggingface dataset:
effectiveness of mycancergene to optimize genetic testing outcomes

Conditions: Cancer; Genetic Predisposition

Summary: this protocol aims to evaluate the efficacy of a theoretically and stakeholder informed patient-centered genetic interactive health communication application to increase patient understanding of, and affective and behavioral responses to genetic testing. the study investigators hypothesize that the intervention will be associated with increases in knowledge, decreases in distress, increases in communication with relatives and health care providers, and increases in performance of risk reducing health behaviors.

as clinical practice increasingly use multi-gene testing, many patients are left with unknowns after genetic testing. many have results that are unclear and may or may not be associated with any risk for cancer (variants of uncertain significance), or mutations in genes with very limited information about disease risk or the best medical management. importantly, many of these uncertainties will be clarified over time, but there is a need for effective ways of communicating these updates to patients who had testing months or years ago. in some cases, there may be multiple updates over time. to address this, this study will provide patients access, using an interactive health communication application, mycancergene, to information about their genetic testing, their specific results and the implications, the ability to print reports and other materials for their relatives and other health care providers and to assess if there has been a change in the personal or family history. additionally, patients can contact their genetic provider through mycancergene and the cancer genetics team can send out updates to patients about their individual results or about new information about risk estimates or screening recommendations. the study investigators hypothesize that mycancergene will be associated with increases in knowledge, decreases in distress, increases in communication with relatives and health care providers, and increases in cancer screening and risk reducing health behaviors. after 12 months, all patients will have access to mycancergene, which will aid in understanding who benefits most and least from this intervention.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * english speaking * male or female * internet and/or mobile access * previously received clinical genetic counseling and testing for hereditary cancer syndromes (up to 60 days prior to recruitment) exclusion criteria: •no internet and/or mobile access
comparing pp and pvdf meshes in midline laparotomy closure for high-risk colorectal surgery. impact on incisional hernia and surgical wound infection.

Conditions: Colorectal Cancer; Wound Infection; Hernia Incisional

Summary: in the latest guidelines for abdominal wall closure in emergency surgery published in the world journal of emergency surgery (wjes) in 2023, no specific recommendations are made in this regard. current literature does not provide any articles comparing these two types of mesh materials (pp vs pvdf) in emergency colorectal surgery. it is necessary to conduct a study comparing these two types of mesh materials, specifically in high-risk patients for incisional hernia and emergency colorectal surgery. this study aims to contribute to generating evidence regarding differences in wound infection incidence and potential subsequent complications, such as chronic pain. it is essential to conduct a study comparing different methods of laparotomy closure, specifically in emergency colorectal surgery, to contribute valuable evidence regarding the incidence of incisional hernia and potential subsequent complications.


Eligibility criteria:
inclusion criteria: * patients diagnosed with colorectal pathology requiring urgent surgical treatment via midline laparotomy. * patients undergoing urgent laparoscopic surgery but requiring conversion to midline laparotomy. * need for urgent surgical treatment involving the colon and/or rectum, even in the presence of other abdominal pathologies. * age over 18 years. * signed informed consent (ic) from both the patient and the investigator * severe chronic obstructive pulmonary disease (copd) according to the gold classification or decompensated copd. * bmi ≥ 35 kg/m2. * re-laparotomies. exclusion criteria: * patients with psychiatric illnesses, addictions, or any disorder hindering the understanding of the informed consent. * inability to read or comprehend any of the languages in the informed consent (catalan, spanish).

Keywords: colorectal cancer wound infection hernia incisional mesh polypropylene pvdf
clinical of drug-eluting stent versus excimer laser ablation combined drug-coated balloon to treat arteriosclerosis occlusive disease of lower extremity

Conditions: Atherosclerosis; Ischemia

Summary: this is a prospective randomized controlled study to evaluate the difference of safety，effectiveness between excimer laser ablation combined drug-coated balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions.

prospective randomized controlled study to evaluate the difference of safety，effectiveness between excimer laser ablation combined drug-coated balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions. patients with femoral-popliteal artery lesions in our department were randomly assigned to the excimer laser ablation combined drug-coated balloon group and drug-eluting stent group. compare the ischemic improvement rate (limb salvage rate, postoperative patency rate) and the complications rate of two different treatments. at the same time, the peri-operative related factors that may affect the end point events, such as preoperative baseline data, lesion characteristics, imaging features, stent fracture, and end point observation indexes were analyzed by regression analysis.

Eligibility criteria:
inclusion criteria： 1.all patients signed an informed consent form; 2.digital subtraction angiography (dsa) revealed femoropopliteal artery stenosis above 70% or occlusion resulting in claudication (rutherford clinical category-becker class ii-iii2-3) or critical limb ischemia (cli) (rutherford clinical category 4-5-becker class iv-v) 3.with unobstructed vascular inflow; 4.with at least a vessel runoff; 5. good compliance and regular follow-up. exclusion criteria: 1. acute or subacute lower limb ischemia caused by acute intraluminal thrombus within the target lesion.; 2. severe calcified lesions （grade 4 in the pacss scale）; 3. in-stent restenosis lesion or surgical arterial bypass grafting; 4. severe renal insufficiency: creatinine level greater than 2.5 mg/dl; 5. platelet count below 100,000/μl or with antiplatelet / anticoagulation contraindications; 6. immunologic diseases or malignant diseases; 7. ongoing active infection; 8. decompensated congestive heart failure or acute coronary syndrome; 9. refuse to sign the informed consent unwillingness to comply with follow-up suggestions.

Keywords: drug-eluting stent debulking femoral artery drug-coated balloon
enose in pulmonary tuberculosis in yogyakarta

Conditions: Pulmonary Tuberculosis Suspected; Other Specified Chronic Obstructive Pulmonary Disease; Pulmonary Tuberculosis TB (+) Histology, (-) Bacteriology

Summary: electronic noses detecting patterns of volatile molecules have recently been introduced for different diagnostic purposes. the diagnostic accuracy of a prototype e-nose device (bruins et al (2013) in bangladesh showed sensitivity of 76.5-95.9% and specificity of 85.3-98.5%. here the investigators test a production type point-of-care hand-held device with less detectors. the investigators explore factors such as food intake, smoking, and co-morbidity, as well as the impact of tb treatment, and address the question whether the device could help monitor disease and response to treatment.

study participants provide wic and after time for consideration, when they approve, provide demographic anonymized data. the study population consists of six groups: group 1 - 20 tb patients aged \> 18 yrs group 2 - 20 non---tb patients \> 18 yrs (screened for tb - other conditions) group 3 - 20 patients with a lung disease - no tb suspects (lung clinics in yogyakarta,indonesia; group 4 - 50 apparently healthy matched controls group 5 - 20 newly diagnosed tb patients enrolled before start of treatment, to be followed over time, until after end of treatment (8 months fu). group 6 - 50 apparently healthy volunteers. study participants breath normally by mouthpiece into the device using a nose clamp - for 5 min during each sampling. electronic data are downloaded and transmitted by internet to zutphen, netherlands where data are processed to build the model.

Eligibility criteria:
inclusion criteria: * age \>18yrs * voluntarily participating exclusion criteria: -

Keywords: pulmonary tuberculosis; electronic nose; diagnostic accuracy
novel multimodality imaging for navigation in skull base surgery

Conditions: Vestibular Schwannoma

Summary: successful neurosurgery to remove tumours around the base of the skull, such as a vestibular schwannoma, depends on achieving maximal tumour removal whilst preserving crucial neurological functions such as facial movement, and maintaining quality of life. current techniques to direct surgery are based on the surgeon's expertise and knowledge of the relevant anatomy, supplemented by the use of electrical recording and stimulation of the facial nerve. however, it is often very difficult to visualise the nerve during surgery and facial nerve paralysis remains a potentially devastating complication of surgery. advanced imaging methods may be used to visualise important neural connections in the brain and computer-assisted processing can generate tumour maps from mri and ultrasound scans. this study aims to utilise these technologies to develop a 3d navigation system for skull base surgery. this study aims to develop a system that will combine mri and intraoperative ultrasound imaging to enhance the surgeon's view of the tumour, facial nerve and other surrounding critical structures during surgery. this information will be made available in the navigation system in the operating room so that operations are more precise resulting in better tumour removal rates and fewer complications. the system will be assessed during the treatment of 20 patients with vestibular schwannoma at the national hospital for neurology and neurosurgery. this feasibility study will validate the different parts of the new system and help us design a future research study to determine its effectiveness in improving patient care. this project will result in safer and more effective neurosurgery, with potential consequent financial savings for the nhs and the uk, in addition to marked improvements in the quality of life of patients and reduced dependency upon others.


Eligibility criteria:
inclusion criteria: * adult patients aged 18-85 years * patients with a vestibular schwannoma who are scheduled for surgery * patients willing and able to provide written informed consent exclusion criteria: * patients aged under 18 years of age or older than 85 years * previous, treated posterior fossa brain tumour(s) * previous ear or facial surgery on ipsilateral side of tumour * neurofibromatosis type ii * participation in other clinical trials * any contraindication for mr imaging * any contraindication for mr contrast agent administration * any contraindication for ct imaging * pregnancy or breast feeding
covid-19 vaccination and breakthrough infections among persons with immunocompromising conditions in the united states

Conditions: Immunocompromised; Immunosuppressed; Covid-19; SARS-COV-2; SARS-COV-2 Infection; Breakthrough Infection

Summary: this retrospective study will evaluate characteristics, vaccine utilization and outcomes among subjects with immunocompromising conditions that received covid-19 vaccination.

the objective of this us-based retrospective cohort study is to evaluate characteristics, vaccine utilization and outcomes among subjects with immunocompromising conditions that received covid-19 vaccination. subjects will be aged 12 years and older and will have no evidence of prior sars-cov-2 infection. the primary analysis will be conducted on subjects vaccinated with bnt162b2. a variety of subgroup analyses and sensitivity analyses are planned.

Eligibility criteria:
inclusion criteria: patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. unique enrollees in the healthverity vaccine dataset anytime after december 10, 2020 2. at least 12 years on the index date (ie, first vaccination date) 3. no evidence of prior covid-19 infection (a medical claim, pharmacy claim, or chargemaster record with a diagnosis code of icd-10-cm u07.1) in the 12 months prior to the index date 4. have 12 months of continuous enrollment with medical benefits (with or without pharmacy benefits) prior to the index date. subjects with an ic condition will be identified via an algorithm developed for use in administrative claims database studies. exclusion criteria: subjects not meeting the criteria above will be excluded.

Keywords: immunocompromised immunosuppressed immunosuppressive drugs covid-19 covid-19 vaccination mrna vaccine sars-cov-2 vaccine bnt162b2 breakthrough infection sars-cov-2 infection sars-cov-2
a study to evaluate alzheimer's disease conversion rate differences between high-risk mild cognitive impairment (mci) and low-risk mci in a real world setting

Conditions: Mild Cognitive Impairment

Summary: this study will be conducted to evaluate the rate of alzheimer's disease conversion differences between high-risk mild cognitive impairment (mci) and low-risk mci.


Eligibility criteria:
inclusion criteria: * participant over 55 years old and less than 90 years old * participant with subjective memory complaint by informant * clinical dementia rating (cdr) of 0.5; memory score box must be at least 0.5 * general cognition and functional performance sufficiently preserved such that a diagnosis of alzheimer's disease cannot be made by the site physician at the time of the screening visit * essentially preserved activities of daily living * absence of dementia * participant with seoul neuropsychological screening battery-dementia version cut-off score between 134.25 and 188.25 * participants and caregivers who give written authorization to use their personal and health data * cognitive decline history within past 6 months from the baseline exclusion criteria: * diagnostic evidence of probable alzheimer's disease consistent with national institute of neurological and communicative diseases and stroke-alzheimer's disease and related disorders association * cdr-global score (cdr-gs) \>1 * participant who has taken memantine, acetylcholinesterase inhibitors, or nootropics prior to participating in this study * any significant neurologic disease: other than suspected incipient alzheimer's disease, such as parkinson's disease, multi-infarct dementia, huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities * neuroimaging: participant with severe subcortical hyperintensities: d3-p3 * magnetic resonance imaging exclusions: presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body * participant who is pregnant, lactating or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile)

Keywords: high-risk low-risk alzheimer's disease observational study
vision restoration with fluidvision accommodating intraocular lens (aiol)

Conditions: Cataract

Summary: the objective of this study is to obtain an initial assessment of the safety and performance of an investigational aiol in patients undergoing cataract extraction and iol implantation.

this study was originally designed as a single arm, unilateral study (one eye, one product only) to obtain an initial assessment of the safety and performance of an investigational iol in subjects undergoing cataract extraction and iol implantation. the study design was later modified to a contralateral study (both eyes, different product in each eye) to compare the safety and performance of the investigational iol to a commercially available monofocal iol.

Eligibility criteria:
key inclusion criteria: * corrected distance visual acuity (cdva) worse than 20/40, or presence of visually significant lens opacity; * preoperative or predicted postoperative astigmatism of ≤ 1.0 diopter (d); * calculated iol power within range. key exclusion criteria: * current medication that may affect accommodation; * systemic disease or concomitant medication that may increase operative risk or confound results; * ocular conditions that may predispose the subject for future complications; * monocular subjects or subjects with significant permanent visual function loss in fellow eye; * previous intraocular or corneal surgery in either eye that may confound the results or increase the risk to the subject, including implantation of a multifocal iol or other presbyopic corrective surgery in the fellow eye; * grade 4 cataract of any type.
red ginseng extract with climacteric symptoms

Conditions: Climacteric Symptoms

Summary: the purpose of this study is to investigate the positive effects of red ginseng extract on intestinal bacterial changes and immunity, free radicals, antioxidant capacity, and autonomic nervous system changes in age of 40\~75 men and women with climacteric symptoms for 24 weeks.

a screening test is conducted for those who have agreed in writing with a detailed explanation of the purpose of this study and research methods, and then a person who meets the selection / exclusion criteria is selected. give a registration number to the person selected as the subject through the screening, and take one pack of the product (3g) once a day for 24 weeks in a human body application test. prior to taking the registration number (1day), the efficacy evaluation items and the safety evaluation items are carried out. at the 24 weeks after the starting point of taking the product of human application test, the evaluation items are conducted through outpatient visits.

Eligibility criteria:
inclusion criteria: 1. age of 40\~75 men and women 2. those who visited the menopausal clinic with complaints of climacteric symptoms due to functional deterioration of various organs such as fatigue, helplessness 3. those who have agreed to voluntarily decide to participate and observe the instructions after hearing the detailed explanation of this human body application test exclusion criteria: 1. those who have suspected symptoms of acute disease (severe infectious disease, severe trauma, severe diarrhea, vomiting, etc.) 2. patients with a history of antibiotic treatment for more than 1 month within the last 6 months 3. those who have gastrointestinal diseases (inflammatory growth disease, active peptic ulcer, etc.) or gastrointestinal surgery (except for simple appendectomy or hernia surgery) 4. those taking health functional foods, lactic acid bacteria, and red ginseng extracts for the past year 5. those who are currently participating in other clinical studies or human trials, or participating in clinical trials or human application tests within the past month
cardiac resynchronization under electroanatomical guidance after failure of primary implantation

Conditions: Cardiac Anomaly

Summary: the purpose of the study is to assess the feasibility of cardiac resynchronization under electroanatomic guidance in the event of primary implantation failure due to catheterization failure or instability in the coronary sinus ostium

as part of this study, to avoid surgery, the doctor will use a 3-dimensional (3d) guidance technique to position the heart probes in an optimal position during a new endovascular intervention.

Eligibility criteria:
inclusion criteria: * patient with indication for implantation of a classic multisite pacemaker; * new york heart association ii/iv patient despite optimal medical treatment; * patient with left ventricular ejection fraction ≤35%; * patient with a widened qrs \> 120ms; * patient with at least one lateral coronary sinus vein visualized on angiography during the 1st procedure (if performed); * patient with failure of resynchronization via the endovenous route due to difficulty in accessing the coronary sinus or instability in the coronary sinus; * patient having been informed and having signed an informed consent form; * patient able to understand the information related to the study (absence of linguistic, psychological, cognitive problem, etc.), and to complete questionnaires. exclusion criteria: * patient with resynchronization failure due to occlusion of the superior vena cava; * patient with no usable lateral coronary sinus vein; * patient with a life expectancy \< 3 months; * patient wearing a vena cava filter; * patient with active sepsis; * pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding; * patient participating in another clinical trial, or in a period of exclusion from another clinical trial; * patient not benefiting from a social security scheme.
study to evaluate the effect of food on the pharmacokinetics of bms-626529

Conditions: Infection, Human Immunodeficiency Virus

Summary: the current food effect study is being performed to support a phase 3 study with bms 663068. results from this study will inform whether patients in the upcoming phase 3 study can be given the flexibility to dose bms-663068 in the fasted state, if so desired.

primary purpose: other: to assess the effect of food on the steady-state exposure of bms-626529 when administered as bms 663068 600 mg twice daily (bid) to healthy subjects acquired immune deficiency syndrome (aids)

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, physical examination findings, 12-lead ecg measurements, and clinical laboratory test results * body mass index (bmi) of 18.0 to 32.0 kg/m2, inclusive * males and females, ages 18 to 50 years, inclusive * women of childbearing potential (wocbp) must have a negative serum or urine pregnancy test (minimum sensitivity 25 iu/l or equivalent units of human chorionic gonadotropin (hcg)) within 24 hours prior to the start of study drug exclusion criteria: * any significant acute or chronic medical illness as determined by the investigator * current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug * any major surgery within 4 weeks of study drug administration * any gastrointestinal surgery that could impact upon the absorption of study drug * inability to tolerate oral medication * recent (within 6 months of study drug administration) history of smoking or current smokers * evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ecg) or clinical laboratory determinations beyond what is consistent with the target population * any of the following on 12-lead ecg prior to study drug administration, confirmed by repeat: * pr ≥ 210 msec * qrs ≥ 120 msec * qt ≥ 500 msec * qtcf ≥ 450 msec * positive urine screen for drugs of abuse * positive blood screen for hepatitis c antibody, hepatitis b surface antigen, or human immunodeficiency virus-1 (hiv-1), -2 antibodies, and hiv-1 rna