Kornimate/medical-research-clean huggingface dataset:
an observational, prospective evaluation of the trifecta™ valve

Conditions: Aortic Valve Insufficiency; Regurgitation, Aortic Valve; Aortic Valve Incompetence; Aortic Valve Stenosis

Summary: this trial is designed to confirm the clinical safety and effectiveness of the trifecta valve by establishing associated adverse event rates, clinical status as indicated by new york heart association (nyha) functional classification, hemodynamic performance, and hematology analysis.

the clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study without concurrent or matched controls, designed to evaluate the safety and effectiveness of the trifecta valve. a maximum of 120 subjects requiring aortic valve replacement will be implanted at a maximum of 6 investigational sites in europe. the sample size is based on late patient-years of follow-up with a minimum of 400 late patient-years experience required.

Eligibility criteria:
inclusion criteria: 1. patient requires aortic valve replacement. (note: patients undergoing concomitant procedures, e.g. coronary artery bypass grafting, or valve repair, are eligible for this study). 2. patient is legal age in host country. 3. patient (or legal guardian) has given written informed consent for participation prior to surgery. 4. patient is willing to undergo all study procedures and adhere to data collection and follow-up requirements. exclusion criteria: 1. patient is pregnant or nursing (women of child bearing potential must have a documented negative pregnancy test within one week prior to surgery). 2. patient already has a prosthetic valve(s) at a site other than the aortic valve. 3. patient requires concomitant replacement of the tricuspid, pulmonary, or mitral valve. 4. patient has an inability or is unwilling to return for the required follow-up visits. 5. patient has active endocarditis (patients with previous endocarditis must have two documented negative blood culture results prior to enrollment). 6. patient has had an acute preoperative neurological event defined as patient has not returned to baseline or has not stabilized 30 days prior to the planned valve implantation surgery. 7. patient is undergoing renal dialysis. 8. patient has a documented history of substance abuse within one year of enrollment or is currently a prison inmate. 9. patient is currently participating in the study of an investigational drug or device, or the patient was previously participating in an investigational drug study and has not completed a 30-day wash out period. 10. patient had the trifecta valve implanted as part of this study, but then had the device explanted. 11. preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm. 12. patient has a life expectancy less than two years.

Keywords: aortic valve heart valve tissue valve bioprosthesis valve disorder valve disease cardiac surgery aortic valve stenosis aortic valve regurgitation
iptp plus itns for malaria control in pregnant women

Conditions: Pregnancy

Summary: we aim to evaluate whether ipt in pregnancy provides any additional benefit to the protection afforded by itns.

pregnant women are at an increased risk for malaria infection and disease. maternal anaemia, low birth weight and prematurity are the most frequent adverse effects of the infection. the current who recommendation consists on the provision of insecticide treated nets (itn's) and intermittent preventive treatment (ipt). results from a recentn trial of itn's have shown a significant reduction in maternal anaemia, parasitaemia and low birth weight prevalence in women sleeping under impregnated nets. however, scarce information exists on the relative efficacy of ipt and itns to reduce the deleterious effects of malaria infection during pregnancy when given at the same time. this information is of relevance to guide national malaria control programmes. this study consists on the administration of two double blind doses of ipt with sulfadoxine-pyrimethamine or placebo at predefined intervals, after the beginning of the second trimester. all women receive an itn.

Eligibility criteria:
inclusion criteria: * less than 28 weeks of pregnancy exclusion criteria: * previous allergic reactions to sulphonamides
oxygen delivery methods of nasal catheter on the incidence of hypoxemia in patients with painless gastroscopy

Conditions: Hypoxemia

Summary: in this study, patients undergoing painless gastroscopy were selected to change the nasal catheter oxygen delivery mode to oral oxygen delivery after endoscope implantation, in order to explore the effect of this oxygen delivery mode on the incidence of hypoxemia during general anesthesia gastroscopy.

this study was a randomized controlled study in which patients undergoing elective painless gastroscopy were selected and grouped by random number table. the control group used conventional nasal cannula oxygen method: nasal cannula was used before, during and after gastroscopy was implanted and after withdrawing from the gastroscopy. test group: before the gastroscope enters the oral cavity, oxygen is administered through a nasal catheter via the nose. after the gastroscope enters the oral cavity, oxygen is administered through the nasal catheter via the mouth. after the gastroscope is withdrawn, oxygen is administered through the nasal catheter via the nose. the incidence of intraoperative hypoxemia was observed.

Eligibility criteria:
inclusion criteria: patients who receiving gastroscopy under general anesthesia, accompanied with one of the following risk factors of hypoxia: 1. patients combined with heart or respiratory diseases 2. age older than 60 3. asa grading ii-iii 4. bmi≥30kg/m², 5. snoring or having sleep apnea syndrome 6. patients with a stop-bang score ≥ 3 (the risk of osas is high) are considered to be highly risk of hypoxia. exclusion criteria: 1. severe cardiovascular, pulmonary, liver, or kidney disease 2. patients with infections or tumors of airway 3. history of difficult intubation under general anesthesia 4. severe sleep apnea syndrome \[hypopnea/apnea hypopnea index (ahi)\>40\] 5. patients allergic to propofol, eggs, soy or egg whites 6. pregnancy
efficacy and safety of continuous intravenous versus usual subcutaneous insulin in acute ischemic stroke

Conditions: Acute Stroke; Acute Cerebral Ischemia

Summary: hyperglycaemia is a frequent finding in acute ischemic stroke and associated with poor outcome. but the modalities of glucose lowering are still debated. this study will test the efficacy and safety of continuous intravenous insulin protocol versus usual subcutaneous insulin in acute ischemic stroke.

it is demonstrated that post-stroke hyperglycaemia is associated with poor outcome. yet, the efficiency of aggressive insulin serum glucose control is not established. furthermore the modalities of insulin administration are discussed since us and european guidelines recommend subcutaneous administration, whereas some groups use intravenous administration of insulin. the purpose of this study is to compare the efficacy and the safety of a continuous intravenous insulin protocol versus classical subcutaneous administration of insulin. the study will include carotid territory stroke at the acute stage (\< 6 hours of onset) confirmed by mri, and randomized in intravenous versus subcutaneous insulin. the percentage of patients in the target range (mean capillary glycaemia within 24 hours \< 7 mmol/l) is the primary outcome. the secondary outcomes include comparison of modified rankin scale at 3 months, rate of hypoglycaemic events and comparison of infarct growth as measured on mri.

Eligibility criteria:
inclusion criteria: * age over 18 years * carotid territory stroke * mri performed in the first five hours of stroke onset * baseline national institutes of health stroke scale (nihss) \> 4 or \< 26 * time between mri and treatment under one hour exclusion criteria: * pre-existing modified rankin scale of three or higher * advanced or terminal illness with risk of death in the next 6 months, addiction

Keywords: acute ischemic stroke post-stroke hyperglycaemia insulin treatment insulin dwi mri
geriatric polytrauma sop

Conditions: Geriatrics

Summary: this study investigated whether there were improvements in the in-hospital mortality, infection rate, and rate of palliative care among geriatric trauma patients after the implementation of new standard operating procedures (sops) for the resuscitation room. these new sops, comprising early whole-body computed tomography (ct), damage control surgery, and the use of goal-directed coagulation management, were designed for severely injured adult trauma patients

this study involved the analysis of a prospective single-centre database. patients admitted via the resuscitation room with need for intensive care treatment after the resuscitation room phase were included and compared before the implementation of the new sops (between 1 january, 2000 and 31 december, 2006) and after their implementation in 2009 (between 1 january, 2010 and 31 december, 2012) of our level-i trauma centre.

Eligibility criteria:
inclusion criteria: inclusion in internal trauma database exclusion criteria: comprised age \< 65 years, iss \< 9, and transfers from other hospitals.

Keywords: algorithm in-hospital mortality multiple trauma standard of care
prevalence of hiv and tuberculosis in masiphumelele township, cape town, south africa

Conditions: HIV Infections; Tuberculosis

Summary: the purpose of this study is to estimate the amount of hiv and tuberculosis (tb) infection in individuals 15 years and older in the masiphumelele township of cape town, south africa. data collected in this study will be used to predict the effect of introducing anti-hiv therapy in this community.

tb is the most common opportunistic infection among hiv infected people, and is the most common cause of death in hiv infected people in africa. the masiphumelele township of cape town, south africa, with its high rates of tb and hiv, is representative of many poor communities of africa. via random sampling, this study will assess the prevalence of hiv and tb infections in the masiphumelele township. knowledge gained from this study will be used to predict if introducing antiretroviral therapy will reduce the prevalence of tb in this community. selection and enrollment of participants will last about 4 months. potential participants will be visited in their homes by fieldworkers, who will explain the study. participants will be invited to either go to the clinic on the day of the fieldworker's visit or to go on a different day. participants who go to the clinic on the day of the visit will have two sputum samples collected with a nebulizer. participants who do not go to the clinic on the visit day will be given a sputum sample bottle and will be asked to collect a sputum sample in the early morning the day before their clinic appointment. at the clinic appointment, another sputum sample will be collected from these participants. direct smear acid-fast bacilli and mycobacterium tuberculosis cultures will be done on both sputum samples. participants who test positive for tb will be referred for tb treatment at the clinic. participants will also be asked to complete a study questionnaire and will undergo an anonymous oral hiv test at the clinic visit.

Eligibility criteria:
inclusion criteria: * resident of the masiphumelele township for at least 1 week prior to study entry * willing to provide informed consent * willing to comply with study requirements
rhodos follow-up single-visit study

Conditions: Leber's Hereditary Optic Neuropathy

Summary: this study aims to evaluate the current visual acuity of snt-ii-003 participants and compare this with the last visit from the snt-ii-003 study.


Eligibility criteria:
inclusion criteria: * previous participation in study snt-ii-003

Keywords: leber's hereditary optic neuropathy idebenone
dpbrn peri-operative pain and root canal therapy

Conditions: Post-operative Tooth Pain; Root Canal Therapy

Summary: the purpose of this study is to identify pre-operative factors that put patients at greater risk of developing severe tooth pain following root canal therapy, thereby providing evidence that will allow dentists to act preventively to lessen this risk, improve pain control, increase their patients' quality of life, and decrease the number of dental emergency interactions. a parallel goal of this study is to assess the feasibility of recruiting dentists that provide root canal therapy and patients using the dpbrn.

goals for this study is to: * assess the frequency and intensity of pre-operative pain * evaluate the occurence and intensity of intra-operative pain * evaluate the occurence and intensity of post-operative pain * assess the interference of persistent tooth pain with daily life * identify a limited set of risk factors related to the development of post-operative pain.

Eligibility criteria:
inclusion criteria: * 19-70 years old * permanent adult tooth requiring it first non-surgical root canal therapy * patients with more than 1 tooth requiring root canal therapy are eligible, but only the first root canal procedure performed will be included to avoid problems of correlation within patients exclusion criteria: * evidence of prior root canal therapy, including iatrogenic, but not disease-induced, pulp access of the tooth being considered * patients with obvious cognitive impairments (e.g., past stroke with communication deficits, dementia, mental disability) * patients unable to return for 6 month follow-up, since another study plans to obtain data of these patients at that time (dpbrn persistent tooth pain)

Keywords: post-operative pain intra-operative pain root canal therapy feasibility post-surgical persistent pain
endoscopic versus surgical treatment for t1 colorectal cancer

Conditions: Colorectal Cancer

Summary: the implementation of population screening programs for colorectal cancer (crc) has led to a considerable increase in the prevalence t1 crc originating on polyps amenable by endoscopy. the benefits of secondary oncological surgery in terms of disease free survival are not well established. hypothesis: the characteristics of the individuals and the polyp (endoscopic, histological) should allow us to discriminate t1 crcs that may benefit from secondary surgery from those that only require local treatment. with the current criteria, the management of patients with t1 crc is suboptimal since a high proportion of patients are refered for unnecessary surgeries without a clear benefit in terms of survival. molecular signatures can help to discriminate those patients with good prognosis that do not require secondary surgery nor cancer related follow up.

the primary objective of the study is to compare the effect of oncological surgery versus local treatment for the management of polyps with t1 crc in relation to disease-free survival and morbi-mortality of the therapeutic procedure. we will also validate molecular signatures in endoscopic samples for the prediction of lymph node metastasis and survival. methodology: clinical study: retrospective population-based cohort study that will include baseline clinical and follow up data of more than 1400 t1 crcs in at least 10 spanish autonomous communities from 2007 to 2017. a centralized pathological review will be carried out by a group of expert pathologists. inter and intraobserver variability for histological staging will be assessed. a predictive model will be created to discriminate individuals with high probability of receiving surgical and local treatment. for those patients who have a similar probability range, the results in progression-free survival and adverse events will be compared. translational phase: a 5mirnas and 8mrna signature predictive of lymph node metastasis will be assessed in 200 endoscopic samples and related with prognosis.

Eligibility criteria:
inclusion criteria: - all patients diagnosed with pt1 crc will be included, regardless of endoscopic features, treatment received and lymph node staging exclusion criteria: * crc with other histology than adenocarcinoma * patients with hereditary syndromes of crc (lynch syndrome, classical familial adenomatous polyposis) or inflammatory bowel disease. * synchronous crc * metachronous crc in the previous 5 years * patients with metastatic neoplastic disease at the time of diagnosis

Keywords: t1 colorectal cancer early colorectal cancer endoscopic polypectomy oncological surgery lymph node metastasis molecular signatures disease free survival
bioequivalency study of 450 mg lithium carbonate under fasting conditions

Conditions: Bipolar Disorder

Summary: the objective of this study was to assess the bioequivalence of two roxane lithium carbonate 450 mg extended release tablet formulations compared to glaxosmithkline's eskalith cr 450 mg extended release tablet under fasting conditions using a single-dose, randomized, three-treatment, three-period, six-sequence crossover design.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * participation in a clinicl trial within 30 days prior to study initiation. * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs.
functional evaluation of brain pain centers in endometriosis-associated chronic pelvic pain exploring the impact of central sensitization using a novel mri technique

Conditions: Novel MRI Technique

Summary: endometriosis is a chronic inflammatory disease characterized by the presence of endometrial tissue outside the uterus, affecting about 10% of reproductive-age women. it is commonly associated with chronic pelvic pain, present in 40-50% of women with persistent pelvic pain and 30-40% of infertile women. the condition contributes to chronic pain through mechanisms like inflammation, neurogenic inflammation, neuroangiogenesis, and central sensitization. central sensitization involves changes in brain function and can be assessed using magnetic resonance imaging (mri). while studies have shown the role of brain changes in chronic pain for conditions like migraine and fibromyalgia, research on pain chronicization in endometriosis is limited. this study focuses on evaluating functional changes in brain pain centers associated with endometriosis-related chronic pelvic pain using neuroimaging. the goal is to enhance understanding of the pathophysiology of chronic pain and emphasize the potential of mri in guiding more effective management strategies for endometriosis.

endometriosis is a chronic disease defined by the presence of endometrial stroma and glands outside the uterus. it affects approximately 10% of women of reproductive age and is detected in 40-50% of women experiencing persistent pelvic pain and 30-40% of infertile women. clinically classified as an inflammatory and systemic disease, endometriosis often manifests as pelvic pain. it is believed that endometriosis contributes to chronic pelvic pain through mechanisms such as inflammation, neurogenic inflammation, neuroangiogenesis, peripheral sensitization, central sensitization, and cross-organ sensitization. central sensitization can be identified by evaluating functional changes in the brain using magnetic resonance imaging (mri). numerous studies have demonstrated the importance of brain functional changes in the chronicization of pain in various conditions, including migraine, fibromyalgia, trigeminal neuralgia, and chronic lower back pain. however, there are limited mri studies investigating the chronicization of pain associated with endometriosis. in this study, we aim to highlight the benefits of neuroimaging in elucidating the pathophysiology of chronic pain by examining the functional changes in brain pain centers in chronic pelvic pain associated with endometriosis.

Eligibility criteria:
inclusion criteria: women aged 18-45 who underwent brain magnetic resonance imaging, including those with endometriosis and those without gynecological pathology, matched for age and body mass index exclusion criteria: patients who were pregnant patients in the postmenopausal period patients who had detected pathologies in brain imaging

Keywords: chronic pelvic pain endometriosis brain pain centers functional connectivity
use of ketamine to enhance electroconvulsive therapy (ect) in depression

Conditions: Major Depression; Bipolar Depression

Summary: the primary objectives of this study are to investigate the potential for ketamine anesthesia to increase the antidepressant efficacy of electroconvulsive therapy (ect) and to decrease acute ect-induced adverse cognitive effects.

electroconvulsive therapy (ect) is one of the most robust antidepressant treatments available. however, there is the potential for significant acute and longer term adverse cognitive effects with ect and the antidepressant response requires multiple treatment sessions, increasing risk of adverse effects. further, antidepressant response to ect is often less than maximal and relapse is common. growing preclinical and clinical evidence of the rapid-acting antidepressant properties of the anesthetic agent ketamine suggests the use of ketamine anesthesia as a strategy to increase rate of response and shorten treatment course in the administration of ect. in addition, preclinical and clinical evidence suggests the potential of ketamine to decrease the adverse cognitive effects associated with ect. the investigators propose a pilot study to measure both acute therapeutic efficacy and cognitive side effects of ect using ketamine compared to methohexital in depressed patients. the investigators will also explore other parameters of ect such as seizure duration and morphology, as well as hemodynamic and behavioral changes.

Eligibility criteria:
inclusion criteria: 1. male or female patients: 18 to 59 years 2. women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study 3. dsm iv mini diagnosis of major depressive episode (mdd), unipolar or bipolar 4. pretreatment 24-item hamilton rating scale for depression score \> 21 5. ect is clinically indicated 6. patient has the capacity to provide informed consent. exclusion criteria: 1. dsm-iv diagnosis of schizophrenia, schizoaffective disorder, or mental retardation 2. current primary diagnosis of anxiety disorder, obsessive- compulsive disorder, or eating disorder that precedes the onset of the current episode of depression 3. current diagnosis of delirium, dementia, or amnestic disorder 4. baseline mini mental state exam (mmse) score \< 24 and a total score falling two standard deviations below the age- and education-adjusted mean 5. any active general medical condition or cns disease which can affect cognition or response to treatment 6. current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week 7. lifetime history of ketamine or pcp abuse or dependence 8. ect within three months 9. the presence of any known or suspected contraindication to methohexital or ketamine including but not limited to known allergic reactions to these agents, uncontrolled hypertension arrhythmia severe coronary artery disease and porphyria 10. pregnancy

Keywords: depression electroconvulsive therapy ketamine antidepressant