Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of evolocumab in ischemic stroke

Conditions: Ischemic Stroke, Acute

Summary: the goal of this clinical trial is to evaluate the effect of evolocumab in combination with statin therapy (atorvastatin) in acute ischemic stroke (ais).


Eligibility criteria:
inclusion criteria: 1. patient age between 18-80 years 2. time of onset: within 1 week 3. nihss score ≤12 4. acute ischemic stroke confirmed by head ct or mri 5. premorbid mrs ≤1 6. signed informed consent exclusion criteria: 1. intracranial hemorrhage found by head ct 2. severe hepatic or renal dysfunction 3. pregnant females 4. abnormal elevation of creatine phosphokinase 5. blood sugar is out of control 6. receiving statins within 1 month before onset 7. not willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures 8. unsuitable for this clinical studies assessed by researcher
clinical trial protocol to evaluate the efficacy and safety of laparoscopic surgical systems for gynaecological surgery

Conditions: Cervical Cancer; Endometrial Cancer

Summary: evaluation of the efficacy and safety of thoracic and abdominal endoscopic surgical systems manufactured by shenzhen cornerstone robotics technology co., ltd. for use ingynaecological surgical procedures.

the trial was designed using a prospective, single-centre, single-group target value approach. for subjects who intend to undergo gynaecological surgery assisted by the thoracic and abdominal endoscopic surgical system. to use the thoracic and abdominal endoscopic surgical system developed by shenzhen cornerstone robotics technology co., ltd. to perform surgery , and to evaluate the efficacy and safety of the experimental medical device in the surgical treatment

Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤ 80 years; * body mass height index (bmi) 18\<bmi\<30kg/㎡; * patients identified by the investigator as suitable for general, gynaecological and thoracic surgery; * written informed consent. exclusion criteria: * need for emergency surgery (e.g. gastric cancer, colorectal cancer combined with perforation, bleeding, obstruction, etc.); * with other malignancies or a previous history of other malignancies. * preoperative imaging suggests that the tumour has distant metastases. * the patient has a history of relevant surgery or previous history of other malignancy and is judged by the investigator to be unsuitable for enrolment. * severe bleeding tendencies or coagulopathic disorders. * with long-term use of anticoagulant and anti-platelet drugs (anti-platelet aggregation drugs discontinued less than 1 week prior to surgery), history of bleeding disorders or hematopoietic or coagulation disorders. * significant immunodeficiency due to underlying illness (e.g. hiv/aids) and/or medication (e.g. systemic corticosteroids). * with severe allergies and suspected or established alcohol, drug or substance addiction. * other conditions which, in the opinion of the investigator, make participation in this trial inappropriate.

Keywords: cervical cancer endometrial cancer
safer aging with diabetes monitoring

Conditions: Diabetes Mellitus, Type 2; Hypoglycemia

Summary: older adults with type 2 diabetes are at higher risk for severe hypoglycemia and its related complications (including hospitalization and death) when taking insulin. this study proposes to evaluate, in a randomized clinical trial, a strategy of safe insulin prescribing based on an educational program that leverages continuous glucose monitoring to support older adults at high risk for hypoglycemia. if the aims of this project are achieved, this novel care strategy could be widely applied to reduce severe hypoglycemia episodes in older, high-risk adults with type 2 diabetes.

the overarching goal of this pragmatic randomized clinical trial is to support safer diabetes care in older adults (age ≥ 75) with type 2 diabetes (t2d) who require insulin therapy. many of these older adults are at high risk for severe hypoglycemia due to symptom unawareness and/or nocturnal hypoglycemia. effective and safe management in this population requires close glucose monitoring coupled with proactive medication and diet adjustment to avoid severe iatrogenic consequences. this study proposes to achieve this goal through a patient-oriented intervention program that incorporates the use of alarm-enabled continuous glucose monitoring (cgm). there are currently no major randomized trials directly assessing the use of cgm to reduce severe hypoglycemia among the oldest adults with t2d. the study team will conduct a 2-arm trial: 1) group-based, three-session education intervention (cgm provided to participants) vs. 2) usual care (no cgm provided to participants). the primary outcome is an aggregate measure of clinically significant hypoglycemia. the study will also examine differences in patient-reported diabetes distress, fear of hypoglycemia, and self-efficacy using validated survey measures.

Eligibility criteria:
inclusion criteria: * age 75 years and older * diagnosis of type 2 diabetes * current treatment with insulin * increased hypoglycemia risk (prior year hypoglycemia by self-report or utilization) * able to communicate in english * able to access email and the internet exclusion criteria: * on renal dialysis * dementia * pacemaker or automatic implantable cardioverter defibrillator * using insulin pump * severe mental illness * severe visual impairment * in hospice * current or recent cgm use

Keywords: hypoglycemia diabetes education continuous glucose monitor
the turkish version of the late life function and disability instrument

Conditions: Disability Physical

Summary: the aim of this study is to investigate the turkish validity and reliability of the late life function and disability instrument (llfdi) and to provide a measurement tool for researchers who wish to work in this field within the turkish literature.

short physical performance battery (sppb), timed up and go test (tug), functional independence measure (fim), and barthel index of activities of daily living (mbi), among others. however, these tests were designed without a clear theoretical or conceptual framework, and their utility and applicability are limited by the physical and cognitive condition of the individuals being assessed. there is a need for practical, adequate, tolerable, and reliable tests that provide consistent results and allow for a comprehensive evaluation of functional status and the effects of treatment. considering the existing tests, the late life function and disability instrument (llfdi) was developed by professors in the department of physical therapy at boston university to assess meaningful changes in both function and disability categories. the llfdi has been translated into hebrew, swedish, french, korean, spanish, canadian portuguese, and brazilian portuguese, with its reliability and validity confirmed. this instrument is widely used in many countries worldwide. however, there is currently no study on the turkish version, validity, and reliability of the late life function and disability instrument (llfdi). the aim of this study is to investigate the validity and reliability of the turkish version of the late life function and disability instrument (llfdi) and to provide a measurement tool for researchers in this field to be used in the turkish literature.

Eligibility criteria:
inclusion criteria: * over 65 years old, * being willing and volunteer to participate in the study, * having reading and writing skills, * being able to read and write in turkish, * having a diagnosis of gonarthrosis, and * scoring above 20 points on the mini-mental test. exclusion criteria: * having a neurological problem

Keywords: disability validity reliability
nexium capsules clinical experience investigation

Conditions: Gastric Ulcer, Duodenal Ulcer, Anastomotic Ulcer, Reflux Oesophagitis,"Non-erosive Reflux Disease, Zollinger-Ellison Syndrome

Summary: the purpose of this study is to confirm the safety profile / factors which impact safety and efficacy of nexium capsules in daily clinical usage for the patients who have been prescribed nexium for "gastric ulcer", "duodenal ulcer", "anastomotic ulcer", "reflux oesophagitis", "non-erosive reflux disease", or "zollinger-ellison syndrome"

nexium capsules clinical experience investigation

Eligibility criteria:
inclusion criteria: - patients treated with nexium for the first time due to gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux oesophagitis, non-erosive reflux disease, zollinger-ellison syndrome. exclusion criteria: - none

Keywords: gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux oesophagitis, non-erosive reflux disease, zollinger-ellison syndrome, nexium
ologen (oculusgen)-phacotrabeculectomy historical control study in india

Conditions: Glaucoma; Cataract

Summary: 1. . study objective: the objective of this study is to determine the safety and effectiveness of the oculusgentm biodegradable collagen matrix implant in phacotrabeculectomy surgery. the primary endpoint is to prove the effectiveness via the reduction of intraocular pressure, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events. 2. . study design: the study is designed as a historical controlled study. patient who meet the inclusion/exclusion criteria and sign the informed consent form will be included for this study. the allocation of subjects is non-randomized, and there is a single group for assignment. 3. . follow-up: this investigation is including 7 post-operative visits and follow-up within 6 months from the date of surgery. patients should be seen at postoperative days 1, 7, 14, 30, 60, 90 and 180. the visit window of ± 7 days is allowed for the 30, 60, 90 and 180 day visits. the further follow-up of subject after trial is continually tracked by the investigator.

ologen collagen matrix is applied for the phacotrabec surgery.

Eligibility criteria:
subject inclusion criteria: 1. age 18 years or over. 2. at least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy. 3. visually significant cataract with visual acuity of less than or equal to 6/12. 4. subject able and willing to cooperate with investigation plan. 5. subject willing to sign informed consent form. subject exclusion criteria: 1. known allergic reaction to collagen. 2. subject is on warfarin and discontinuation is not recommended. 3. subject with normal tension glaucoma or aphakic glaucoma. 4. subject with corneal disease. 5. participation in an investigational study during the 30 days proceeding phacotrabeculectomy. 6. ocular infection within 14 days prior to phacotrabeculectomy. 7. pregnant or breast-feeding women. 8. monocular subject.

Keywords: glaucoma collagen matrix oculusgen phacotrabeculectomy anti scarring tissue engineering ologen aeon astron
psychometric validation of the camouflaging autistic traits questionnaire

Conditions: Autism Spectrum Disorder

Summary: for many affected individuals, despite impairment and distress, autism spectrum disorder (asd) is recognized and diagnosed late, in school age, adolescence, or even in adulthood, which could be due, among other things, to the use of compensatory strategies such as so-called "camouflaging" by the respective individual. in order to better investigate and quantify these adaptive and compensatory strategies of individuals with autism, the camouflaging autistic traits questionnaire (cat-q) has recently been developed and validated in the english-speaking world. the cat-q is designed to assess the extent of camouflaging behavior, in which autistic individuals consciously or unconsciously attempt to conceal or attenuate their autistic traits in order to better adapt to social situations. so far, however, there is no german-language questionnaire that can be used to validly assess camouflaging. the aim of the planned research project is to psychometrically validate the cat-q in german-speaking adolescents aged 13-21 years. the validation of the cat-q represents an important basis for further research on the construct camouflaging and can subsequently contribute to an improvement of diagnostics as well as support the development of individual treatment approaches.


Eligibility criteria:
inclusion criteria study group: - patients who meet the principal diagnosis of asd, which includes atypical autism (icd-10: f84.1) and asperger syndrome (icd-10: f84.5), and are between the ages of 13 and 21 years old. exclusion criteria study group: * dementia / below average cognitive abilities (iq \< 85) * lack of german language skills * severe visual or hearing impairment (uncorrected) inclusion criteria control group: - adolescents who do not have a lifetime principal diagnosis of a psychiatric disorder (icd-10-gm-2016: f10 - f69) and are between 13 and 21 years old. exclusion criteria control group: * dementia / below average general cognitive ability (iq \< 85) * lack of german language skills * severe impairment of vision or hearing (not corrected).

Keywords: camouflaging late diagnosis adolescents
evaluation of comprehensive geriatric assessment and laboratory biomarkers in elderly patients with multiple myeloma

Conditions: Plasma Cell Myeloma

Summary: this study evaluates the association between a comprehensive geriatric assessment and laboratory biomarkers with the side effects of chemotherapy in older patients with multiple myeloma (mm). the comprehensive geriatric assessment is a tool that can help to determine how fit a patient is. it is composed of a series of questions and tests designed for older people to evaluate their physical function, mental status, mental health, nutritional status, social support, level of social activity, and the presence of other medical problems. in addition to geriatric assessment domains, laboratory biomarkers may provide information on physiologic dysfunction as a measure for evaluation of frailty in the cancer setting. this study will help researchers in the future by predicting which patients will have more side effects with chemotherapy based on their comprehensive geriatric assessment and laboratory biomarkers, which will allow adjustments to treatment in older adult patients with mm.

primary objective: i. to evaluate the association between a baseline comprehensive geriatric assessment (cga) and chemotherapy toxicity in the first 4 months of treatment measured by treatment-related adverse events, patient-reported outcomes (pros), and treatment discontinuation in older patients (\>= 65 years) with multiple myeloma (mm). secondary objectives: i. to evaluate the association between a baseline cga and baseline disease- and host- related laboratory characteristics and cytogenetic risk profile by fluorescence in situ hybridization among newly diagnosed older (\>= 65 years) patients with mm. ii. to evaluate how the cga changes over 4 months from the start of treatment and the association between those changes and treatment response in older patients (\>= 65 years) with mm. iii. to evaluate the association between proposed frailty biomarkers at baseline and treatment toxicity in the first 4 months of treatment measured by treatment-related adverse events, pros, and treatment discontinuation in older (\>= 65 years) patients with mm. outline: this is an observational study. patients complete surveys and undergo cga, blood sample collection, and electronic health record (ehr) review on study.

Eligibility criteria:
inclusion criteria: * age \>= 65 years * diagnosis of mm based on international myeloma working group (imwg) diagnostic criteria * newly diagnosed or have received 1 prior line of treatment * planned to start a new treatment for mm within 30 days * transplant eligible or ineligible * fluent in english (all assessment tools are in english) * able to provide written informed consent exclusion criteria: * received \> 1 prior line of treatment * patients included in an interventional therapeutic trial * not able to give informed consent * severe mental or cognitive disorder precluding geriatric assessment
mabioncd20 compared to mabthera in lymphoma patients

Conditions: Diffuse Large B-Cell Lymphoma

Summary: the aim of the study is to demonstrate the high level of biosimilarity between mabioncd20 (mabion sa) and the reference product: mabthera (rituximab by hoffman-la roche) in patients with cd20-positive diffuse large b-cell lymphoma.

patients who meet criteria for participation in this study receive 8 intravenous infusions of mabioncd20® or mabthera® 21 days interval in combination with standard dosage regimen of chop. the duration of the study is 12 months. the treatment and observation period will last 26 weeks starting from day 1, until week 26 - one month after last imp infusion.

Eligibility criteria:
inclusion criteria: 1. patients with histological confirmed cd20 (cluster of differentiation 20) positive diffuse large b cell lymphoma (dlbcl) 2. patients that had been diagnosed according to the who classification; 3. performance status ≤ 2 on the ecog (eastern cooperative oncology group) / who (world health organization) scale, performance status of 3 will be accepted if impairment is caused by dlbcl complications and improvement is expected once therapy is initiated; exclusion criteria: 1. life expectance less than 6 months; 2. any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 28 days prior to treatment; 3. rituximab, other anti-cd20 mab (monoclonal antibodies) drug treatment, treatment with any cell depleting therapies - e.g., anti-cd4 (cluster of differentiation 4) anti-cd5 (cluster of differentiation 5), anti-cd3 (cluster of differentiation 3), anti-cd19 (cluster of differentiation 19), anti cd11 (cluster of differentiation 11), anti-cd22 (cluster of differentiation 11), blys/baff (b lymphocyte stimulator/b-cell activating factor) within 1,5 years before screening;
safety of heparin in patients with septic shock

Conditions: Sepsis

Summary: sepsis is a syndrome comprised of a systemic inflammatory response, signs of tissue hypoperfusion, and organ in the setting of presumed infection. heparin, in addition to being an anticoagulant, is also a well-known antiinflammatory. the investigators believe that unfractionated heparin has the potential to save the lives of septic patients at a drastically reduced cost. this is a dose escalation study to determine the safety of increasing levels of heparin in this patient population; compare markers of anticoagulation and inflammation between treatment groups; and compare clinical outcomes between groups.


Eligibility criteria:
inclusion criteria: 1. age 18-90 in the medical or surgical intensive care unit 2. within 24 hours of diagnosis with sepsis as defined by the bone criteria (see appendix a); 3. acute physiology and chronic health evaluation (apache ii) score of \> 25; 4. signed consent exclusion criteria: 1. currently therapeutically anticoagulated for known thrombotic diagnosis (myocardial infarction, venous thromboembolism) known molecular hypercoagulable state (factor v leiden, lupus anticoagulant, antiphospholipid antibody syndrome); or use of cardiopulmonary support machines (left-ventricular assist device, intra-aortic balloon pump, veno-venous ultrafiltration, or extracorporeal membrane oxygenation. 2. history of gastrointestinal or cerebral hemorrhage within past 3 months; 3. active bleeding; 4. known allergy or sensitivity to heparin; 5. history of heparin-induced thrombocytopenia 6. organ transplantation recipient -

Keywords: sepsis septic shock anticoagulation intensive care unit
assessing success of mta and pre-mixed bioceramic in mature teeth with irreversible pulpitis with full pulpotomy.

Conditions: Pulpitis - Irreversible

Summary: although many pulpotomy agents are commercially available, there is a dearth of clinical research comparing the efficacy of these agents in treating individuals with irreversible pulpitis. bioceramic and mta both have similar clinical uses, but bioceramic is distinguished from mta by its superior chemical, physical, and biological properties. this study aims to address this knowledge deficit by assessing the performance of biocompatible materials in pulpotomy procedures for the treatment of symptomatic permanent teeth in adults with deep caries. for permanent teeth with a completed root and a diagnosis of irreversible pulpitis without apical periodontitis, this research will compare the success rates of mta and ebrrm pulpotomy procedures in order to provide evidence-based clinical practice guidelines for the treatment of this disease.

the goal of this observational study is to test and compare the success of full pulpotomy with mineral trioxide aggregate (mta) pre-mixed bioceramic in mature teeth with irreversible pulpitis. participants in this study were patients with irreversible pulpitis without apical periodontal pathosis recruited from the waiting list at the school of dentistry at liaquat university of medical and health sciences in jamshoro. after obtaining informed consent, demographic information, clinical examination results, and binary variables were recorded pre- and intra-operatively. the study's primary aim was to assess postoperative pain, and secondary aims included assessing the presence of swelling, sinusitis, or fistula and detecting tooth mobility. participants received either mta or endo sequence bioceramic root repair randomly allocated using a lottery system. follow-up assessments were done initially, after 6 days, and after 6 months, and periapical radiography was done at 6 days and 6 months to detect radiolucency.

Eligibility criteria:
inclusion criteria: 1. patients with diagnosis of irreversible pulpitis without apical periodontitis 2. either gender 3. lower age 10 years - upper age 40 years exclusion criteria: * teeth displaying indications of resorption. * teeth that have not fully developed, characterized by open apices. * canals that are calcified or obstructed. * perforations that were caused by the dentist. * fractures in the root * teeth that cannot be restored * • teeth that are unable to withstand frigid temperatures, have a sinus infection, or have swelling around them. * there has been no pulp exposure despite the removal of carious lesion. * ten minutes after a pulpotomy, hemorrhage could not be stopped. * necrotic or partly necrotic pulp is indicated by insufficient bleeding after exposure.