Kornimate/medical-research-clean huggingface dataset:
tempus sculptor study: small cell lung cancer (sclc) observational study

Conditions: Small Cell Lung Cancer

Summary: the study is a non-interventional evaluation of participants with sclc who will receive diagnostic and (where possible) post-progression tumor tissue profiling, alongside plasma ctdna biomarker profiling in addition to their standard of care therapy and disease surveillance.


Eligibility criteria:
the following are the inclusion criteria. participants are eligible to be included in this study only if all the following criteria apply. the participant has/is: * histologically confirmed small cell lung cancer diagnosis * diagnosis made with excisional or core needle biopsy specimen (fine needle aspirate may be permitted with approval from the pi) * subjects must submit fresh or archived ffpe tumor sample to the central laboratory * ecog performance status of 0-2 at time of enrollment * planned extensive stage first-line therapy of etoposide plus carboplatin plus pd-l1 inhibitor (atezolizumab or durvalumab) * extensive stage disease at time of diagnosis * willing and able to provide informed consent * radiotherapy is permitted as long as there is measurable disease outside of the radiotherapy port participants will be excluded from the study if any of the following criteria apply. the participant has/is: * history of prior systemic treatment of sclc * prior diagnosis of non-small cell lung cancer is excluded if the cancer is diagnosed \< 3 years prior to study entry. additionally, the participant must be off all therapy for the nsclc at the time of study entry. * mixed small cell and non-small cell histology * suspected metastatic cancer from other sites (i.e., those without a known or suspected lung primary diagnosis) * not willing to have additional blood samples collected

Keywords: cancer oncology observational genomic profiling precision medicine sclc small cell lung cancer ngs biomarkers ctdna transcriptomics
a randomised, open-label, cross over group, single-centre controlled study to evaluate the clinical performance of medium cut-off membrane dialyser compared with high flux dialyser among patients with chronic haemodialysis

Conditions: Hemodialysis-Associated Amyloidosis; Dialysis Amyloidosis; Quality of Life

Summary: this is an open label, cross-over group, single-centre randomised controlled trial comparing medium cut off dialyser with high flux dialyser in patients with end-stage renal disease on chronic haemodialysis.

this is an open label, cross-over group, single-centre randomised controlled trial comparing medium cut off(mco) dialyser with high flux dialyser in patients with end-stage renal disease on chronic haemodialysis. patients who are initially on high flux dialyser will be randomised into either mco dialyser (modality a) or high flux dialyser (modality b) dialysate. the dialysate flow (qd) and blood flow (qb) remains unchanged throughout study period. after 12 treatments (4 weeks) a 4-weeks wash-out phase using high-flux dialyzers was performed to minimize carry-over-effects. after the 4-weeks washout phase, the modality is switched to the alternative one for 8 weeks.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or above 2. end stage kidney failure receiving hemodialysis for at least 3 years 3. currently receiving hemodialysis at our center regularly 4. written informed consent exclusion criteria: 1. patients with hemodiafiltration 2. catheter-related blood stream infection in the preceding 4 weeks 3. malfunctioning of hd catheter 4. planned transfer to peritoneal dialysis or transplant within 90 days 5. pregnancy 6. history of active alcohol or substance abuse in the previous 6 months 7. concurrent participation in another interventional study 8. other medical condition which, in the investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes

Keywords: hemodialysis-associated amyloidosis dialysis amyloidosis quality of life
optimization post-tavr to improve activity levels (optimal study)

Conditions: Aortic Valve Disease; Aortic Valve Replacement

Summary: in this study, the investigators will evaluate the feasibility and potential efficacy of programs to improve functional outcomes after minimally-invasive transcatheter aortic valve replacement (tavr). the investigators will examine the potential efficacy of (a) a motivation interviewing program, and (b) a home-based physical activity + motivational interviewing program, compared to (c) usual care + enhanced education in patients post-tavr procedure.


Eligibility criteria:
inclusion criteria: * undergoing tavr procedure * ≥65 years old * ambulatory at baseline without assistance * approval of the interventional cardiologist that the patient is an appropriate candidate * can access telephone or teleconference exclusion criteria: * impaired cognition that would limit participation in study activities * medical comorbidities that substantially limit exercise * major cardiac comorbidities, including ejection fraction\<35%, history of cardiac arrest, complex dysrhythmias at rest, clinically-significant incomplete revascularization, implanted cardiac defibrillator. * physical characteristics that substantially limit exercise * high fall risk (johns hopkins fall risk assessment tool indicating high risk) * non-english speaking * vigorous exercise at least 2 times/week for \>30 minutes * any other physician judgement

Keywords: aortic valve replacement minimally invasive transcatheter aortic valve replacement tavr
dahanca 33: image guided dose-escalated radiotherapy to patients with hypoxic hnscc

Conditions: Locally Advanced Head and Neck Cancer; Radiotherapy; Hypoxic Radioresistance

Summary: aim: to improve curability of radiotherapy in hnscc patients identified by hypoxic faza-pet scanning

prospective phase ii study aiming to improve the outcome in hypoxic resistent patients identified by faza-pet. inclusion: patients must fulfill the following: positive hypoxic faza-pet scanning (as described in dahanca 24 - see citation) stage iii-iv, squamous cell carcinoma of the larynx, pharynx or oral cavity (hpvneg (oropharynx) indication for hyperfractionated accelerated radiotherapy with concommitant cis-platin and nimorazole

Eligibility criteria:
inclusion criteria: * stage iii-iv larynx, pharynx, oral cavity * hypoxic faza-pet positive * indication for primary radio-chemotherapy * informed consent exclusion criteria: * hpv positive oropharynx cancer * primary surgery
the comparison between the therapeutic affect of intravitreal diclophenac and triamcinolone in persistent uveitic cystoids macular edema

Conditions: Uveitis; Cystoid Macular Edema

Summary: cystoids macular edema (cme) is one of the most common causes of low vision due to uveitis. the treatment for reducing the intra-ocular inflammation can decrease the macular edema. in some patients, cme persists even after inflammation control, and additional treatment is needed for better vision. oral steroid, periocular and intravitreal triamcinolone are the principles in treatment, but some complications like cataracts and increased ocular pressure have been seen. diclophenac is a non-steroid anti-inflammatory drug that improves the vision and decreases the macular thickness by slowing down the prostaglandin e2 (pge2) ending in vascular endothelial growth factor (vegf) inhibition. in this study, the investigators are going to compare the therapeutic affect of intravitreal diclophenac and triamcinolone in persistent uveitic cystoids macular edema. since diclophenac is a cheap and accessible drug in all curative centers it could be applied instead of triamcinolone.


Eligibility criteria:
inclusion criteria: * cystoids macular edema which is diagnosed by oct and flurocein angiography * 5/200 \< visual acuity \< 20/50 * resistance to routine treatment (oral treatment, periocular injection) exclusion criteria: * history of retinal disease cause macular edema like diabetes * arterial occlusion * monocular patients * patients candidate for intra-ocular operation * history of glaucoma or ocular hypertension * any cataract that would interfere with oct
iloprost in high risk cardiac surgical patients

Conditions: Pulmonary Hypertension

Summary: in this study effects of the intra operative, prophylactic inhalation of iloprost (ventavis) before and during extracorporal circulation on perioperative morbidity and outcome in high risk cardiac surgical patients is investigated in comparison to placebo.


Eligibility criteria:
inclusion criteria: * written informed consent * for females of childbearing potential: negative pregnancy test * patients, male or female, 18 to 85 years old * elective open-heart surgery using heart-lung-machine * patients with increased risk to suffer from perioperative right heart failure, i.e., * protracted surgery: multiple valvular transplant or expected bypass time exceeding 120 min and/or * patients with preoperative known pulmonary hypertension and/or * patients with severe heart insufficiency (nyha iii or nyha iv) exclusion criteria: * patient not able to give consent * pregnant or nursing patients * anamnestic known hypersensitivity to the used drug (ventavis) and its ingredients or to drugs with a similar chemical structure * blood clotting disorder requiring treatment * trauma, intracerebral bleeding or apoplexy within the last 3 months prior to surgery * primary or secondary immune deficiency (e.g., pretreatment with steroids, cytostatics) * systemic infection * lung disorder with impaired gas exchange * lung transplantation * cardiac transplantation * implantation of lvad (left ventricular assist device) * fluoride ulcus disorder * planned surgery in deep hypothermia and cardiac arrest * subconscious and psychiatric disordered patients * participation in another clinical trial within the last 30 days prior to study start and up to 30 days after end of study * previous participation in this study

Keywords: iloprost pulmonary hypertension cardio pulmonary morbidity high risk cardiac surgical patients
efficacy and safety of oral anticoagulants among thai octogenarians with nonvalvular atrial fibrillation

Conditions: Stroke; Atrial Fibrillation

Summary: a retrospective cohort study of thai octogenarians with nonvalvular atrial fibrillation (nvaf) initiating apixaban, dabigatran, rivaroxaban or warfarin was conducted in medical school hospital in thailand. patients were recruited from january 1, 2013, to december 31, 2018. the efficacy outcome was early recurrence of stroke or transient ischemic attack (tia) in 90 days after initiation of oral anticoagulants (oacs). the safety outcome were major bleeding and clinically relevant non-major bleeding complications in 180 days. continuous variables were compared using independent t test and mannwhitney u test, and categorical variables were compared using chi-square test or fisher's exact test. furthermore, hazard ratios and p values were calculated by the use of multivariable cox's regression analysis.

this is a retrospective cohort study of thai octogenarians with nvaf. patients who were prescribed with apixaban, dabigatran, edoxaban, rivaroxaban or warfarin from january 1, 2013, to december 31, 2018 were recruited. the primary efficacy was recurrent ischemic stroke or tia in 90 days after initiating oacs. the secondary efficacy were recurrent ischemic stroke or tia in 180 days after initiating oacs. while any bleeding complications were defied as primary safety outcomes. continuous variables were compared using independent t test and mannwhitney u test, and categorical variables were compared using chi-square test or fisher's exact test.

Eligibility criteria:
inclusion criteria: * age more than 80 years old * patients who were diagnosed with i48, i63 or g45 from international classification of diseases 10th version (icd-10). patients who were diagnosed atrial fibrillation and flutter, cerebral infarction or transient cerebral ischemic attacks (tia) and related syndromes) * patients were prescribed apixaban, dabigatran, edoxaban, rivaroxaban, or warfarin exclusion criteria: * patients were prescribed oral anticoagulants for other indications 1. prophylaxis thromboembolic events in valvular atrial fibrillation 2. treatment of venous thromboembolism 3. prophylaxis thromboembolic events in hip or knee replacement * patients who had contraindication to oral anticoagulants 1. creatinine clearance calculated from cockcroft-gault equation 1.1 creatinine clearance less than 30 ml/min (for patients who receiving dabigatran) 1.2 creatinine clearance less than 15 (ml/min (for patients who receiving apixaban, edoxaban, rivaroxaban) 2. patients were diagnosed acute hepatitis, chronic active hepatitis

Keywords: anticoagulant drugs
telemedicine influence in the follow up of the type 2 diabetes patient

Conditions: Type 2 Diabetes; Telemedicine; Self Monitoring Blood Glucose; Primary Care

Summary: the purpose of this study is to evaluate the impact of a a real time teleassistance system in the clinical evolution of type 2 diabetic patients on self monitoring blood glucose in the public national primary care system.

the ukpds study in type 2 diabetes and the dcct in type 1, showed that intensive blood glucose control and the following hba1c decrease were associated with a decrease of diabetic complications. introducing telecontrol elements in the real time follow up of the patients, should help to know continuously patient blood glucose profile and add if necessary immediately therapeutical variations, to maintain hba1c levels as low as possible. the study compares type 2 diabetes patients performing self monitoring of blood glucose, followed up by their family doctor in their primary care unit with the extra support of a real time teleassistance system with type 2 diabetes patients performing self monitoring of blood glucose, followed up by their family doctor in their primary care unit.

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes * on smbg al least 6 months before * age superior of 30 years * controlled in province of málaga primary care units exclusion criteria: * having diabetic complications or other diseases that could make difficult to use the telemedicine system * patients who need a carer * not passing the initial training (low cultural level) * living in an area without mobile phone coverage
macrophage markers in periodontal and peri-implant health and disease

Conditions: Peri-Implantitis; Periodontitis

Summary: macrophage surface markers (cd80, cd163 and cd206) will be evaluated in periodontally healthy gingiva, healthy peri-implant mucosa, and periodontitis and peri-implantitis lesions.

soft tissue biopsies obtained from clinically healthy gingiva, healthy peri-implant mucosa, stage iii grade c periodontitis lesions and peri-implantitis lesions will be evaluated. healthy peri-implant samples are obtained from submerged implants during exposure surgery. healthy gingiva samples are obtained from individuals receiving crown lengthening, gingivectomy or tooth extraction as excess tissue during the corresponding treatment. samples from peri-implantitis and periodontitis (pocket depth ≥6 mm, bleeding on probing+) are obtained during initial periodontal treatment / debridement procedure with a single stroke at the pocket wall. the samples will be grinded and ultrasonicated. western blotting will be used for determination of cd80, cd163 and cd206 in biopsy specimens. imagej will be used for intensity analysis of the bands.

Eligibility criteria:
inclusion criteria: * diagnosed with generalized grade c stage iii periodontitis * diagnosed with peri-implantitis * periodontally healthy individuals with dental implants in the primary healing period * periodontally healthy individuals who are in need of crown lengthening / gingivectomy or extraction exclusion criteria: * systemic disease * smoking / former smokers * regular medicine intake * antibiotic or anti-inflammatory medicine intake in the last 3 months * pregnancy or lactation
neoadjuvant colorectal cancer with unresectable liver metastases

Conditions: Colorectal Neoplasms; Liver Neoplasms

Summary: the study was terminated early due to low enrollment with only 2 subjects enrolled and treated after being open for enrollment for over a year. therefore, no meaningful efficacy analyses could be performed. this trial is studying the effects (good and bad) of a combination of drugs, irinotecan in combination with infusional 5-fu, leucovorin (folfifi) plus bevacizumab, for cancer of the colon or rectum that has spread to the liver only and is currently not able to be removed by surgery. all of the drugs that will be received in this research study have been approved in the united states for colorectal cancer, that has spread to other areas of the body, including the liver. another reason for doing this study is to see if the chemotherapy drugs folfifi plus bevacizumab can sufficiently decrease the size of the cancer in the liver so that any tumor remaining can be completely removed with surgery and, if it can be removed whether doing so will prolong the time it takes the cancer to return and/or prolong the life of these patients. this trial is also looking at the genes of people who take part in this study, to see if it is possible to find out characteristics that can help predict whose cancer will respond well or not so well, and who will have more or less side effects to this chemotherapy.


Eligibility criteria:
inclusion criteria: * ecog performance status of 0 or 1 * histological documentation of adenocarcinoma of the colon or rectum. the primary site must have been confirmed to be in the large bowel exclusion criteria: * prior systemic anticancer therapy for mcrc * prior hepatic surgery, chemoembolization, hepatic artery infusion, radiofrequency ablation or cryotherapy for liver metastases
a phase iv study of bms-232632 in hiv+ patients with metabolic syndrome

Conditions: HIV Infections

Summary: the purpose of this clinical research study is to learn if bms-232632 administered as atazanavir/ritonavir (atv/rtv) is superior to an anti-retroviral regimen including lopinavir/ritonavir (lpv/rtv), as assessed by an increased brachial artery flow-mediated vasodilatation (fmd), in hiv-infected patients. the safety of this treatment will also be studied.


Eligibility criteria:
inclusion criteria: - documented metabolic syndrome by at least 3 of the following parameters: * abdominal obesity, assessed by waist circumference (for men \>103 cm, for women \>88 cm). * triglycerides \> 150 mg/dl. * hdl cholestrol (for men \<40 mg/dl, for women \<50 mg/dl). * blood pressure \> or equal to 130/85 mm hg. * fasting serum glucose \> or equal to 110 mg/dl. * hiv rna \< 50 copies/ml. * ip within 3 months prior to selection. exclusion criteria: -treated metabolic syndrom
oral axl/mer/csf1r selective tyrosine kinase inhibitor in patients with advanced solid tumor

Conditions: Solid Tumor; Advanced Cancer; Metastatic Cancer

Summary: this is a phase 1, open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study with cohort expansion at the rp2d to evaluate safety and anti- tumor activity of q702 administered orally.


Eligibility criteria:
inclusion criteria: * patients with histologically or cytologically confirmed advanced or metastatic solid tumors, that have progressed following standard of care therapy or for which there is no standard therapy which confers clinical benefit * measurable disease per recist v 1.1 * ecog performance status 0 or 1 * life expectancy of at least 3 months * age ≥ 18 years * signed, written irb-approved informed consent form exclusion criteria: * new york heart association class iii or iv cardiac disease, or myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, congestive heart failure within the past 6 months * have a corrected qt interval (using fridericia's correction formula) (qtcf) of \>470 msec (females) and \>450 msec (males) * active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy * active, poorly controlled autoimmune or inflammatory diseases
comparison of intralase and visumax femtosecond laser for laser in situ keratomileusis

Conditions: Myopia

Summary: emtosecond lasers are used in cutting the flap in lasik procedures (laser corrective surgery for refractive error). their use has decreased the incidence of serious complications when compared to the use of microkeratomes(mechanical blades). the commonest femtosecond laser currently used is 'intralase'. a newer femtosecond laser 'visumax' (zeiss) is now available and differs from the intralase in that it does not interfere with the curvature of the cornea when creating the flap. the intralase applanates the cornea flat during flap creation which causes the intraocular pressure to be higher. both intralase and visumax lasers are available to patients and surgeons to use at snec. the aim of the investigators study is to compare the two lasers in a randomization of left and right eyes in the same patient. the investigators want to measure any difference that the lower intraocular pressure may have during the creation of the flap. this will be measured with a questionaire on patient experience during the procedure and the outcomes of vision, refraction, contrast sensitivity, wave-front analysis, tear function,corneal sensation and flap thickness measured with anterior segment oct during the post-operative follow up period. to date no-one has compared the use of these two femtosecond lasers. both lasers are currently used clinically for flap creation at snec.


Eligibility criteria:
inclusion criteria: * 21 years of age or older. * cycloplegic spherical equivalent of \>-1.00d * refractive cylinder -4.00 d or less. * best spectacle corrected visual acuity (bscva) of 6/12 or better in both eyes. * spherical or cylindrical error has progressed at -0.50d or less per year from date of baseline measurement. * contact lens wearers must have removed contact lenses at least two (2) weeks before the baseline measurement. * no evidence of irregular astigmatism on corneal topography. * available to attend post-operative examinations for a 3 month period. exclusion criteria: * progressive or unstable myopia and/or astigmatism. * clinical or corneal topographic evidence of keratoconus. * residual, recurrent or active ocular disease such as uveitis, severe dry eyes, severe allergic eye disease, glaucoma, visually significant cataract and retinal disease. * previous corneal surgery or trauma within the corneal flap zone. * patent corneal vascularization within 1mm of the corneal flap zone. * taking systemic medications likely to affect wound healing, such as corticosteroids and antimetabolites. * systemically immunocompromised. * systemic disease likely to affect wound healing, such as diabetes, connective tissue disease and severe atopy. * pregnant or nursing.

Keywords: lasik femtosecond laser visumax intralase myopia myopic patients undergoing lasik