Kornimate/medical-research-clean huggingface dataset:
x-change hf - exchange of the existing pacemaker/icd in bradycardia patients suffering from heart failure

Conditions: Heart Failure, Congestive

Summary: the goal of x-change hf is to estimate the effect of biventricular stimulation in patients who need antibradycardia ventricular stimulation (more than 80%); are eligible for the exchange of an old pacemaker or implantable cardioverter defibrillator (icd); and have ventricular dysfunction (left ventricular ejection fraction \[lvef\] \< 35%). all patients eligible for participation in the study will be upgraded with a cardiac resynchronization therapy (crt)-device and receive either right ventricular or biventricular stimulation in a crossover protocol. the endpoint is functional performance measured by spiroergometry.


Eligibility criteria:
inclusion criteria: * implanted dual-chamber pacemaker or icd system with replacement indication * because of battery end of life * because of upgrade from pacemaker to icd system * predominant sinus rhythm (paroxysmal atrial fibrillation \[af\] \< 2 hours/day) * predominant ventricular stimulation (\>= 80%) * nyha class ii-iii * lvef \<= 35% exclusion criteria: * nyha class iv * life expectancy of less than one year because of accompanying diseases * myocardial infarction less than 3 months old * cardiac surgery less than 3 months * bypass * valve surgery * percutaneous transluminal coronary angioplasty (ptca) * thoracotomy, for implant of an epicardial lv electrode * medical circumstances that make participation and compliance impossible * patients who are not willing or able to give written consent for their study participation * participation in another study * patients less than 18 years old * pregnancy

Keywords: heart failure lvef < 35% bradycardia
danazol in treating patients with advanced or recurrent endometrial cancer

Conditions: Endometrial Cancer

Summary: rationale: hormone therapy may be an effective treatment for endometrial cancer. purpose: phase ii trial to study the effectiveness of danazol in treating patients with advanced or recurrent endometrial cancer.

objectives: i. assess the antitumor activity of danazol in patients with advanced or recurrent endometrial cancer. ii. determine the nature and toxicity of danazol in these patients. outline: patients receive oral danazol 4 times per day for at least 4 weeks. patients with partial response, complete response, or stable disease continue treatment in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. projected accrual: a total of 23-56 patients will be accrued for this study within 26 months.

Eligibility criteria:
disease characteristics: histologically proven advanced or recurrent endometrial cancer that is not amenable to curative surgery or radiotherapy measurable disease tumor at least 1.0 cm by 1.0 cm per x-ray or physical exam or tumor at least 2.0 cm by 2.0 cm per ct scan, mri, or ultrasound patient characteristics: age: not specified performance status: gog 0-2 life expectancy: not specified hematopoietic: wbc at least 3000/mm3 platelet count at least 100,000/mm3 no history of porphyria hepatic: bilirubin no greater than 1.5 times normal sgot no greater than 3 times normal alkaline phosphatase no greater than 3 times normal renal: creatinine no greater than 2 mg/dl other: no concurrent or prior malignancy within past 5 years (except nonmelanoma skin cancer) or for which patient received chemotherapy not pregnant or nursing fertile patients must use effective contraception must have tissue available for estrogen receptor/ progesterone receptor analysis prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: not specified radiotherapy: at least 3 weeks since prior radiotherapy and recovered surgery: at least 3 weeks since prior surgery and recovered

Keywords: stage iv endometrial carcinoma recurrent endometrial carcinoma
a study comparing the efficacy and safety of etrolizumab to infliximab in participants with moderate to severe ulcerative colitis who are naïve to tumor necrosis factor (tnf) inhibitors

Conditions: Ulcerative Colitis

Summary: this is a multicenter, phase iii, randomized, double-blind, double-dummy, parallel-group study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with infliximab in treating participants with moderate to severe ulcerative colitis (uc) who are naive to tumor necrosis factor (tnf) inhibitors. participants will be randomized in a 1:1 ratio to receive either etrolizumab 105 milligrams (mg) by subcutaneous (sc) injection once every 4 weeks (q4w) + placebo (intravenous \[iv\] infusion at weeks 0, 2, and 6, then once every 8 weeks \[q8w\]) or infliximab 5 milligrams/kilogram (mg/kg) iv at weeks 0, 2, and 6, then q8w) + placebo (sc q4w). time on treatment is 54 weeks.


Eligibility criteria:
inclusion criteria: * moderately to severely active uc as determined by the mayo clinic score assessment (mcs) * naive to treatment with any anti-tnf inhibitor therapy (including tnf inhibitor biosimilars) * an inadequate response to or intolerance of prior corticosteroid and/or immunosuppressant treatment * background regimen for uc may include oral 5-aminosalicylate (5-asa), oral corticosteroids, budenoside multi-matrix system (mmx), probiotics, azathioprine (aza), 6-mercaptopurine (6-mp), or methotrexate (mtx) if doses have been stable during the screening period * use of highly effective contraception during and at least 24 weeks after the last dose of study drug exclusion criteria: * a history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic, radiation or microscopic colitis, crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps * prior or planned surgery for uc * past or present ileostomy or colostomy * have received non-permitted inflammatory bowel disease (ibd) therapies (including natalizumab, vedolizumab, efalizumab, and tofactinib) * history of moderate or severe allergic or anaphylactic/anaphylactoid reactions to chimeric, human, or humanized antibodies; fusion proteins, or murine proteins; hypersensitivity to etrolizumab or any of its excipients * chronic hepatitis b or c infection, human deficiency virus (hiv) or tuberculosis (active or latent)
the cogcov study in icu patients

Conditions: Covid19; Cognitive Impairment

Summary: acute respiratory distress syndrome (ards) is a pulmonary systematic inflammatory response, leading to acute respiratory failure with hypoxia and/or hypercarbia. covid-19 evokes a viral pneumonia, which may result in ards as well. it is not yet clear if covid-19 disease behaves like the typical ards. corona virus causes primarily deep hypoxia. hypoxia, on its own, can lead to long term cognitive impairment. however, critical illness also affects long-term neurocognitive functioning. the investigators will be researching the possibility of long-term cognitive impairment in covid-19 icu patients, in comparison with reference values of a healthy population as well as the values measured in critically ill patients, admitted not only for respiratory reasons.

the investigators will conduct a single centre, prospective cohort study. covid-19 patients from the ziekenhuis oost-limburg cohort will be contacted by phone 6 months after admission at the icu. patients will be asked to participate in a study surrounding long term symptoms of covid-19. when consent is given by the patiënt, the experimenter will conduct a short questionnaire over the phone with the patient or relative that is present at the time of the call. if the participant is fluent in dutch, the experimenter will ask permission to visit their home to conduct more testing.

Eligibility criteria:
inclusion criteria: * admitted to the intensive care unit of ziekenhuis oost-limburg * being hospitalized between march 2020 and may 2020, and therefore being admitted 6 months prior to the study * the reason of hospitalization was covid-19 disease exclusion criteria: * no willingness to participate, and therefore not having signed the informed consent
implicit and explicit assessment of suicide risk

Conditions: Implicit Association Test; Suicide; Prevention, Suicide; Suicide Risk Factor

Summary: in 2007 nock \& banaji developed a so-called implicit suicide risk measurement using a computer tool: the implicit association test (iat). this measurement, associated with traditional evaluations, makes it possible to better predict suicidal recurrence. in 2020, the poitiers team of tello was able to replicate these results on a french population. however, although a high iat score predicts the onset of suicide at 1 year, there is no data on how this score changes over time nor even data concerning the measure's ability to differentiate a population with explicit suicidal ideation from a population without explicit suicidal ideation. the investigators therefore seek to demonstrate an evolution of implicit suicidal ideation over time by replicating the measurement at inclusion, at 6 months and at 12 months, for different patient profiles: suicidal ideation vs no suicidal ideation and suicide attempt vs no suicide attempt. patients will be recruited from the emergency-unit of chu amiens-picardie and will take the suicide-iat as well as various questionnaires.


Eligibility criteria:
inclusion criteria: * person presenting to emergencies for psychiatric reasons * adult person * free and informed consent signed * person speaking and writing french fluently exclusion criteria: * neurological disorders or major cognitive deterioration: presence of confusion * acute psychotic decompensation * troubled acute behavior * abuse impregnation of a toxic substance and / or drug impairing cognitive functions at the time of assessment * adult under protective measure.

Keywords: implicit association test suicide prevention, suicide suicide risk factor
loop t2d observational study

Conditions: Diabetes Mellitus, Type 2

Summary: an observational study to collect data on the efficacy, safety, usability, and quality of life/psychosocial effects of the community-derived os-aid loop system on adults with type 2 diabetes.

the study will include adults with type 2 diabetes in the united states, with a recruitment goal of a maximum of 100 participants. data to be collected to address the study objective will include cgm metrics; hba1c; insulin delivery data; carbohydrate data; activity data from healthkit; self-reported adverse events (e.g., severe hypoglycemia, diabetic ketoacidosis, hospitalizations); self-reported device issues; and user experience/treatment satisfaction surveys. follow-up data will be collected on a monthly basis as long as the study is continuing and participants are still using loop.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * age ≥18 years old * currently using any version of loop other than v3.0.0 or planning to start using any version of loop other than v3.0.0 loop within the next 30 days * willing and able to provide informed consent and to complete surveys and provide the device data that are part of the protocol * resident of the us * english speaking/reading * access to email/phone exclusion criteria: * none

Keywords: loop type 2 diabetes diabetes mellitus glucose metabolism disorders metabolic diseases endocrine system diseases autoimmune diseases immune system diseases
enhanced triage for covid-19

Conditions: COVID-19; SARS-CoV 2

Summary: this study is to evaluate of the accuracy of biomarkers (i.e. circulating endothelial and immune activation markers) that indicate progression to severe disease in patients with suspected covid-19 in the emergency department. it is a prospective observational study of patients presenting to emergency departments with a clinical suspicion of covid19. all participants will have plasma samples collected for biomarker analysis, and will be tested for sars-cov-2 infection with a nasopharyngeal swab. participants will be managed according to the best local practices.


Eligibility criteria:
inclusion criteria: * patients presenting with clinical suspicion of covid-19 infection, as per uhn case definition at the time of presentation * age \>18 years * ability to provide verbal informed consent exclusion criteria: * patients who are not suspected of covid-19 infection, as per uhn definition at the time of presentation
relationship between ambulatory arterial stiffness index and left ventricular diastolic function in patients with hfpef

Conditions: Heart Failure With Preserved Ejection Fraction

Summary: heart failure with preserved ejection fraction (hfpef) was considered as a heterogeneous disease with multi-organ and multi-system design, which is related to various complications, such as hypertension, obesity and arteriosclerosis. ambulatory arterial stiffness index (aasi) is associated with arteriosclerosis and hypertension. there is no report on whether aasi is associated with left ventricular diastolic dysfunction in patients with hfpef.

heart failure with preserved ejection fraction (hfpef) is related to various complications, such as hypertension, obesity and arteriosclerosis. ambulatory arterial stiffness index (aasi) is associated with arteriosclerosis and hypertension. aasi is especially associated with left ventricular diastolic dysfunction in patients with hypertension. patients with hfpef have obvious left ventricular diastolic insufficiency. however, there is still no research investigating the the relationship between aasi and left ventricular diastolic dysfunction in patients with hfpef.

Eligibility criteria:
inclusion criteria: adult aged \>=18years old; diagnosed with hfpef. exclusion criteria: lvef less than 45% at any time; severe liver failure; other causes of shortness of breath, such as severe pulmonary disease or severe severe valvular disease of the left heart; chronically bedridden or incapacitated; age \<18 years old.
anxiety level and oral hygiene practice in dental students during covid-19 pandemic

Conditions: Anxiety; Covid19; Oral Hygiene

Summary: covid-19, the infection caused by a novel corona virus detected in december 2019 in wuhan (hubei province), is now a pandemic announced by world health organization, raising concerns of widespread panic and increasing anxiety in individuals. this outbreak results in mass quarantine in egypt since middle of march 2020. brooks et al. (2019) reviewed and reported quarantine could bring "post traumatic stress symptoms, confusion, and anger. stressors included longer quarantine duration, infection fears, frustration, boredom, inadequate supplies, inadequate information, financial loss, and stigma.". many universities decided to suspend in-person classes and evacuate students in responding to the intensifying concerns surrounding covid-19. this action can lead to negative psychological consequences among college students. oral health related behavior and attitudes habits correlate with oral health status and can be considered to be its predictors . there is a claim of potential connection between high bacterial load in the mouth and complications associated with covid-19 infection. bacteria present in the meta genome of patients severely infected with covid-19 included high reads for prevotella, staphylococcus, and fusobacterium, all usually commensal organisms of the mouth. over 80% of patients in icu exhibited an exceptionally high bacterial load. accordingly, the investigators assume that good oral hygiene better to be maintained during a covid-19 outbreak in order to reduce the bacterial load in the mouth and the risk of a bacterial super infection in case of catching the infection . while there seems to be a common belief that psychosocial stress affects oral hygiene behavior, this assumption has rarely been proved9 dental students, as the future providers of dental care, are ex¬pected to be role models for their patients regarding the oral hygiene practice and they supposed to be aware of the importance of preserving the oral health. thus, we intended to select them as our population to study how the level of anxiety during pandemic could affect the practice of oral hygien

a cross sectional study (survey) will be conducted among dental students in faculty of dentistry cairo university for the duration of one month from june 2020 to july 2020. the questionnaire has three parts. the first part included demographic details. the second part included validated general anxiety disorder scale gad-7. questionnaire consisting of seven questions which measures students' anxiety level score. scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. the third part the validated self administered, structured, and close ended 15 questions that assessed the self reported oral hygiene practices 11. the questionnaire forms were kept anonymous. the questionnaire was validated.

Eligibility criteria:
inclusion criteria: * student of faculty of dentistry, cairo university exclusion criteria: -

Keywords: anxiety covid19 oral hygiene practice dental students questionnaire
study for patients with untreated gastric cancer who will receive capecitabine and lapatinib

Conditions: Neoplasms, Gastrointestinal Tract

Summary: the study will determine if changes in expression of markers involved in the 5-fu pathways are associated with response to treatment with the combination of lapatinib and capecitabine independent of tumor erbb2 status.


Eligibility criteria:
inclusion criteria: * has signed inform consent * untreated, newly diagnosed, advanced metastatic or unresectable gastric cancer, including the gastro-esophageal junction * tumor accessible to and patient consent for endoscopic biopsy at study start and after 7 days of single agent lapatinib * measurable disease according to recist criteria * male or female \> or = 18 years of age * cardiac ejection fraction within the institutional range of normal as measured by echocardiogram * must have adequate organ function as defined by baseline laboratory values exclusion criteria: * gastric carcinoid, sarcomas, or squamous cell cancer * pregnant or lactating females * intractable nausea, vomiting, or gastro intestinal obstruction requiring decompression and drainage with a gastric tube or nasogastric suction. * patients who require continuous enteral feeding * malabsorption syndrome or uncontrolled inflammatory gi disease (crohn's or ulcerative colitis * known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure

Keywords: tumor biopsy capecitabine first line gastro esophageal (ge) junction cancer gastric cancer newly diagnosed ge junction lapatinib metastatic or unresectable
efficiency of rigid versus non-rigid indirect anchorage during canine retraction: a split mouth randomized study

Conditions: Orthodontic Appliance Complication

Summary: indirect anchorage (in-a) has been broadly used for anchorage reinforcement during anterior segment retraction. the study compared between the efficacy of rigid vs non-rigid connections of in-a i during upper canine retraction in dentoalveolar protrusion cases

fifteen female patients with dentoalveolar protrusion were included in this study. a miniscrew was inserted following levelling and alignment between the upper first molar and second premolar of both sides. randomization was applied before first premolar extraction where one side of the arch received a rigid indirect anchorage connection (group i) of 0.019 x 0.025-inch stainless steel (st.st) archwire from the miniscrew to the auxiliary tube of the upper first molar band, and the other side received a non-rigid indirect anchorage connection (group ii) of 0.014-inch st.st ligature ligating the upper second premolar to the miniscrew. canine retraction was performed on 0.017 x 0.025-inch st.st archwire applying 1.5 n retraction force. the duration of the study was 7 months. data was collected from digitized models where anchorage loss of the upper first molar relative to the frontal plane and the vertical position of the upper second premolar were measured

Eligibility criteria:
inclusion criteria: adult females bimaxillary protrusion requiring first premolars extractions full permanent dentition good oral hygiene exclusion criteria: history of previous orthodontic treatment abnormalities in teeth size and/or shape vertical, transverse, or anteroposterior skeletal discrepancies anti-inflammatory medication
ventilator settings on patients with acute brain injury

Conditions: Acute Brain Injury; Ventilator-Induced Lung Injury; Cerebrovascular Circulation

Summary: the present study is an explorative analysis of the relationship between cerebral blood perfusion and oxygenation and lung mechanical variables at different ventilator settings. it is a safety study excluding patients with severe lung injury or brain edema.

the primary goal is to carry out baseline measurements to enable conclusions concerning the safety of lung protective ventilator settings before extending the study to patients with more severe brain and/or lung injury in the future. the primary objective is to investigate if lung protective ventilator settings (higher positive end-expiratory pressure and lower tidal volume) as compared with conventional settings. 1. increase intracranial pressure 2. diminish cerebral vasoreactive autoregulation as assessed by pressure reactivity index, ie pressure reactivity index will turn positive, which means that it will change the state from intact to impaired autoregulation. the secondary objective is an exploratory analysis of the relationship between ventilator settings and other well defined respiratory, cerebral, and cardiovascular variables, including transpulmonary pressure.

Eligibility criteria:
inclusion criteria: * • any tracheally intubated or tracheotomized adult patient with abi with gcs\< 9 on controlled ventilation requiring continuous icp measurement. * proxy informed consent from relatives. exclusion criteria: * • icp \> 22 mmhg before treatment of high icp * acute respiratory failure defined as partial pressure of oxygen/ inspiratory oxygen fraction (pao2/fio2) ratio \< 40 kpa and xray pathology * history of pulmonary disese: chronic respiratory failure diagnosis stage iii and iv in the gold classification, pulmectomy, lobectomy or restrictive lung disease. * body mass index (bmi) \> 35. * known right or biventricular cardiac failure with cardiac index \< 2,5 l/min/m2 or ejection fracture \< 40 %. * refractory hypovolemia as diagnosed with pulse pressure variation \> 12 % with tidal volume 8 ml/predicted bodyweight (intubated on controlled ventilation) or passive leg rise test with \> 10 % increase in stroke volume measured by vti echocardiography or picco. * medulla lesion that affect the autonomic nervous system. * patients who has undergone decompressive craniectomy.