Kornimate/medical-research-clean huggingface dataset:
electrocardiogram clinical validation study

Conditions: Atrial Fibrillation

Summary: the purpose of the study is to confirm the garmin ecg (electrocardiogram) software algorithm can detect and classify atrial fibrillation and normal sinus rhythm on single lead ecg data derived from a garmin wrist-worn, consumer device. the study will also confirm the software's ability to create a lead i ecg that is clinically equivalent to a reference device. the garmin ecg software is not a diagnostic system and is intended for informational purposes only.


Eligibility criteria:
inclusion criteria: * able to read, understand, and provide written informed consent; * willing and able to participate in the study procedures as described in the consent form; * individuals who are 22 years of age and older; * able to communicate effectively with and follow instructions from the study staff; * have a wrist circumference that fits within the device band; and * for subjects enrolled into the af population, subjects must have a known diagnosis of af and be in af at the time of screening. exclusion criteria: * physical disability that precludes safe and adequate testing; * mental impairment resulting in limited ability to cooperate; * subjects with a pacemaker or implantable cardioverter-defibrillator (icd); * acute myocardial infarction within 90 days of screening or other cardiovascular disease that, in the opinion of the investigator, increases the risk to the subject or renders data uninterpretable; * acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis within 90 days of screening; * stroke or transient ischemic attack within 90 days of screening; * subjects taking rhythm control drugs; * symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo, dermatomyositis, or allergic contact dermatitis on both wrists or over electrode attachment sites, including known allergy or sensitivity to silicone bands primarily used in wrist-worn fitness devices; * known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or ecg electrodes; * a history of abnormal life-threatening rhythms as determined by the investigator; * significant tremor that prevents subject from being able to hold still; * women who are pregnant at the time of study participation; and * subjects enrolled into the sr population must not have any diagnosis of af.
tranexamic acid in cyanotic heart defects

Conditions: Postoperative Hemorrhage

Summary: the use of antifibrinolytic agents such as to reduce blood loss in congenital cardiac surgery has been described in many studies

40 patients in each one of the three groups; in control group will receive normal saline, intravenous tranexamic acid group received 50 mg / kg intravenousely followed by of 1 mg/kg/hr.for six hours. the topical tranexamic acid group will have 50 mg / kg of tranexamic poured into the pericoredial cavity. in the first 24 hours we will measure the total blood loss and transfusion requirements. complate blood picture and coagulation studies will be recorded. the occurrence of re-exploration for excess bleeding, or adverse events.

Eligibility criteria:
inclusion criteria: 2 to 12 years cyanotic cardiac disease with cardio pulmonary bypass exclusion criteria: previous cardiac surgery any operation within 48 hr., previous inotropes or mechanical vention aprotinin exposure liver or renal impairment coagulation or hemostatic dysfunction within the last 7 days before surgery.

Keywords: pediatric cyanotic heart disease tranexamic acid postoperative blood loss
a phase 2a study to evaluate edp-938 in the virus challenge model

Conditions: RSV Infection

Summary: a randomised, phase 2a, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered edp-938 in healthy subjects infected with rsv-a memphis 37b. this study is designed to compare the antiviral effect of edp-938 compared to a placebo control in the respiratory syncytial virus challenge model.


Eligibility criteria:
inclusion criteria: * an informed consent document signed and dated by the subject * age 18 to 55 years, inclusive * in good health with no history of major medical conditions * a total body weight ≥ 50 kg and body mass index (bmi) ≥ 18 kg/m\^2 and ≤ 30kg/m\^2 exclusion criteria: * pregnant or nursing females * acute or chronic medical illness * abnormal lung function * positive for human immunodeficiency virus (hiv), active hepatitis a, b or c test * nose or nasopharynx abnormalities * receipt of any investigational drug within 3 months prior to the planned date of viral challenge/first dose of study drug

Keywords: challenge study rsv antiviral rsv-a memphis 37b
cystic fibrosis and fit-to-fly

Conditions: Cystic Fibrosis; Hypoxemia; Lung Diseases

Summary: due to the hypobaric hypoxia during air travel, some patients with cystic fibrosis (cf) need supplemental oxygen during air travel. the study aims to evaluate if adding exercise desaturation to the pre-flight evaluation will help predict requirements for in-flight supplemental oxygen.

according to the british thoracic society (bts) recommendations regarding pre-flight evaluation in patients with pulmonary disease, pre-flight arterial oxygen saturation or lung function tests do not discriminate sufficiently between those who need supplemental oxygen during flights, and those who can do without.therefore, more extensively use of hypoxia altitude simulation test (hast) has been advocated. however, this test is not widely available. previous studies have shown that exercise testing is useful for the prediction of in-flight hypoxemia. the investigators have previously developed a pre-flight algorithm for patients with chronic obstructive pulmonary disease (copd), based on oxygen saturation measured by pulse oximetry at rest and during exercise (six minute walking test (6mwt)). it remains unknown as to whether these results are applicable to the cf population. the current study aims to validate the pre-flight algorithm for patients with cf. since a maximum cardiopulmonary exercise test (cpet) is recommended in the routine cf-control, the investigators also aim to evaluate whether the use of cpet predicts in-flight hypoxemia with greater accuracy than 6mwt, and whether cpet may replace hast.

Eligibility criteria:
inclusion criteria: * adult cf patients (age from 18 years) * signed informed consent exclusion criteria: * ongoing exacerbation * unable to fulfill a cpet or 6mwt * long-term oxygen treatment (ltot) * severe heart disease * language problems that interfere with data collection

Keywords: pre-flight evaluation air travel pulseoximetry exercise desaturation hypobaria hypoxemia
ivf\icsi outcome in women with polycystic ovary syndrome

Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Summary: polycystic ovarian syndrome (pcos) occurs in 5% to 10% of all women of reproductive age and 50% of women who present with sub-fertility due to anovulatory infertility . clear diagnostic criteria for this condition were identified at the consensus meeting of the european society of human reproduction and embryology and the american society for reproductive medicine .

sub-fertile women with pcos will usually benefit from conventional treatments, such as lifestyle changes, ovulation induction, or laparoscopic ovarian drilling, but some will ultimately need assisted reproductive techniques, either if they will need or if they wish, such as controlled ovarian hyperstimulation and ivf. in these cases, controlled ovarian hyperstimulation is closely related to high drug costs, need for daily injections and frequent monitoring, whereas it sometimes results in an increased rate of cycle cancellations and potential life threatening complications due to ovarian hyperstimulation syndrome and in the retrieval of immature oocytes, leading to poor fertilization and lower cleavage, pregnancy, and live birth rates compared to the conventional ivf cycles ,although this has not been confirmed by other studies . in addition, ovulation induction is associated with a high risk of multiple pregnancies due to multiple follicular development, so that it has to be individualized and closely monitored. in-vitro fertilization (ivf) is a common therapeutic modality used in infertile women. ivf has different success rates in different subgroups of patients. it is necessary to alter the common standard protocols to overcome the potential obstacles in some populations of patients and achieve the best results . obesity with pcos status of patient may decrease the fertilization rate and clinical pregnancy chance after ivf (probably by decreasing the oocyte count and increasing the gonadotropin resistance); however, the results of different studies are conflicting

Eligibility criteria:
inclusion criteria: * oligo-ovulation or anovulation. * clinical and/or biochemical hyper androgenesim. * polycystic ovaries. exclusion criteria: 1. androgen-secreting tumors (ovarian or adrenal). 2. adult-onset congenital adrenal hyperplasia. 3. thyroid diseases. 4. cushing's syndrome. 5. diabetes mellitus. 6. recurrent icsi failure 7. endocrine, hematologic and autoimmune disorders 8. non chromosomal and genetic abnormalities 9. major uterine anomalies, bad surgical history, sever endometriosis, , hydrosalpinx, uterine fibroids 10. azospermia
prospective study of end stage renal disease patients with coronary artery disease treated by oral nicorandil

Conditions: Coronary Artery Disease; End Stage Renal Disease

Summary: nicorandil is potentially effective to prevent cardiovascular events in patients with coronary artery disease (cad) receiving hemodialysis. the purpose of this study is to prospectively investigate whether nicorandil is effective in reducing the incidence of cardiovascular events in patients with cad on hemodialysis.

patients on hemodialysis for end-stage renal disease are at high risk for death from ischemic heart disease. it was reported that nicorandil, a hybrid compound on adenosine triphosphate-sensitive potassium channel opener and nitric oxide door, was potentially effective to prevent cardiovascular events in patients with cad receiving hemodialysis. therefore, investigators prospectively examine whether nicorandil is effective in reducing the incidence of cardiovascular events in patients with cad on hemodialysis. the primary endpoint is a composite of cardiovascular death, sudden cardiac death, nonfatal myocardial infarction, hospitalization for recurrent symptomatic myocardial ischemia and stroke. the secondary endpoints are total mortality, revascularization therapy, hospitalization for heart failure, hospitalization for peripheral artery disease and newly onset of atrial fibrillation. patient population that needs to prove the hypothesis is estimate to be 300 cases in total (150 cases in each group). investigators set the parameters which are need to calculate the number of study patients as follows; drop out rate 10%, an event rate of the primary end point for two years 50%, a risk reduction rate brought by nicorandil 60%, a statistical power 80% and two-sided significant level 0.05. investigators referred the event rate and the risk reduction rate from the previous study by ishi h et al. in this study, event rate of the primary end point for two years was 50% and the risk reduction brought by nicorandil was 60%. event rate of the present study will be lower, because drug-eluting stents are widely used to prevent restenosis in the present era. moreover, investigators include the patients underwent coronary bypass graft in the present study. in addition, non-cardiovascular mortality is high in the patients on hemodialysis. considering all the various factors together, investigators estimated the study sample size.

Eligibility criteria:
inclusion criteria: eligible patients are who meet the following criteria: * patient with previously diagnosed coronary artery disease (significant coronary artery stenosis is defined as \> 75% narrowing of the artery lumen) * patients who continued hemodialysis for more than one month exclusion criteria: * within one month after acute myocardial infarction * within 3 months after coronary artery bypass graft (cabg) * treatment with phosphodiesterase type 5 inhibitor * candidates for carotid artery stenting * severe disease requiring active medical treatment

Keywords: nicorandil randomized control study hemodialysis coronary artery disease
mri for tumor during chemoradiation for anal canal and perianal cancer

Conditions: Anal Cancer Patients; Perianal Patients

Summary: the purpose of this study is to establish a prospective database of anal canal and perianal cancer patients treated with imrt and chemotherapy with curative intent at pmh for the purposes of investigating mri-derived primary tumor parameters. patients who decide to participate in this study will be treated according to standard treatment policies and radiation therapy planning protocols at princess margaret hospital (pmh) with radiation therapy +/- chemotherapy. imrt for all treatment phases of radiotherapy has been implemented as standard treatment. surgery is reserved for salvage treatment.

anal cancer is an uncommon cancer, accounting for 2% of gastrointestinal cancers. prognostic factors include tumor differentiation and staging, along with patient gender, race, and socioeconomic status. the standard of care is radical chemoradiation with 5-fluorouracil and mitomycin c, with surgery reserved for salvage. intensity modulated radiation therapy (imrt) is a specialized radiotherapy technique that may be used for anal cancer. imrt allows the radiation dose to conform to the three-dimensional shape of the target volume more than conventional two-dimensional techniques, and it may reduce treatment toxicities without compromising tumor control. at the princess margaret hospital (pmh) since july 2007, imrt for all treatment phases of radiotherapy has been implemented as standard treatment for patients with anal canal and perianal cancer.

Eligibility criteria:
inclusion criteria: * histological confirmation of invasive primary squamous cell carcinoma or adenocarcinoma of the anal canal or perianal region * treatment with curative intent * patients who are not eligible for chemotherapy and receive imrt alone are eligible for evaluation * primary anal or perianal cancer evaluable on cross-sectional imaging (ct or mri) scan * ecog performance status of 0, 1, or 2 * age \> 18 years * able to provide informed consent exclusion criteria: * evidence of distant metastasis (m1) * prior radiation therapy to the pelvis or contraindication to radiotherapy * contraindication to mri imaging * known allergy to intravenous gadolinium * renal insufficiency (serum creatinine greater than 150) * serious claustrophobia * cardiac pacemaker * hip prosthesis * major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of imaging study

Keywords: perianal cancer anal cancer mri scan
validation of ai models to measure physical activity after a stroke

Conditions: Stroke

Summary: the research team are developing algorithms using artificial intelligence that use information collected by accelerometers to detect a person's position, such as whether an individual is lying, sitting, or standing, and the individual's movements, such as whether they are taking steps or standing up. sensor location will affect the accuracy of the model and acceptability of the method. the research team are therefore developing algorithms for four different locations. the purpose of the research is for the development of the algorithms and check whether they accurately recognise different positions and movements in people whose movement is affected by a stroke, and by being in a hospital environment (e.g. using a profiling bed). the research team plan to recruit between 34 and 50 participants who are admitted hospital due to having a stroke. after providing informed consent, participants will be asked to complete a one-off assessment with a member of the research team and a ward physiotherapist. participants will be asked to wear the four sensors, and move through a series of postures, walk for up to six minutes, and stand as many times as they feel able in one minute.


Eligibility criteria:
inclusion criteria: * admitted to hospital with a diagnosis of an acute stroke. exclusion criteria: * unable to provide informed consent; * receiving end-of-life care; * the consultant in charge of their care disagrees with their inclusion
anti-inflammatory effects of rosiglitazone in patients with stage 4 and 5 chronic kidney disease

Conditions: Chronic Kidney Disease; Inflammation

Summary: the purpose of this study in patients with stage 4 and 5 chronic kidney disease is to determine whether rosiglitazone can reduce inflammatory markers and to investigate its effect on intima media thickness, calcification and pulse wave velocity.

this is a double-blind randomised placebo-controlled clinical multicenter trial in patients with stage 4 and 5 chronic kidney disease. eligible patients in the outpatient kidney clinic and patients at the dialysis department will be informed by their treating physician about the study and they will be asked to join the study. following informed consent the eligible patients will undergo baseline evaluation and will then be followed for a period of 48 weeks. patients will be randomly divided in two groups: one group will take rosiglitazone (4 mg during the first 8 weeks once daily and 8 mg during the next 40 weeks once daily) and the other group will get placebo. the original medication will be continued. the total follow-up will be 48 weeks. at the start of the study and at 4, 8, 12, 18, 24 and 48 weeks during follow-up inflammatory parameters (crp, hs crp, fetuin, fibrinogen), lipid profile,iron status, glucose and insulin will be measured. intima media thickness, pulse wave velocity, bone densitometry,subjective global assessment will be performed at 0, 24 and 48 weeks.

Eligibility criteria:
inclusion criteria: * written consent * over 18 years of age * stage 4 or 5 chronic kidney disease according the k/doqi guidelines exclusion criteria: * life span of less than one year * alcohol abuse * transaminases \> 2.5 times the upper limit * diabetes mellitus * pregnancy * cardiac disease with marked limitation of functional capacity (nyha iii or iv) * use of immunosuppressant agents
analgesic efficacy after pancreatobiliary surgery: intravenous versus patient-controlled epidural

Conditions: Pancreatic Cancer; Biliary Tract Neoplasms

Summary: prospective, single institute based, open label, double arm, randomized controlled trial hypothesis: pain control after resection of hepatobiliary tumors in patients with pcea is more effective than in patients with iv-pca.

postoperative pain control is important in helping patients who underwent abdominal surgery to recover and to live a normal life. there is a method of administering painless injections to relieve postoperative pain. currently, iv-pca is mostly used. however, this method has a disadvantage in that the dosage of the opioid-based analgesic is increased, and thus side effects may be concerned. by administering analgesics through an epidural route approached through the thoracic vertebrae rather than intravenous injection, effective post-operative pain control and less side effects can be expected in lesser amounts. this study prospectively compared the pain control effects of iv-pca and pcea in patients undergoing resection of hepatobiliary tumors at the national cancer center, revealing that pcea is more effective in alleviating pain after surgery. it has a purpose. in addition, the investigators will investigate and compare clinical outcomes (first fart, dietary progression, postoperative complications, etc.) of the two patient groups and investigate the side effects of pcea and complications related to the procedure.

Eligibility criteria:
inclusion criteria: * pancreatobiliary malignancies * anticipating open surgery * written concent exclusion criteria: * history of previous upper abdominal open surgery * psychiatric problems * cognitive impairment * chronic pain elimination criteria * rejected written concent * failure to follow instructions of doctor * stopped surgery due to peritoneal metastasis
measurement of age and sex related changes in nasal tip support using digital newton meter

Conditions: Nasal Valve Incompetence; Alar Collapse

Summary: background: it is predicted that the nasal tip support will decrease with aging due to weakening of cartilage and connective tissues. however, there is no consensus on the age at which this change began. it is quite difficult to evaluate the nasal tip support, while the ideal nasal tip support pressure is also not known. the aim of this study is to determine the nasal tip support pressure alterations in various age groups, by measuring nasal tip support with a newton meter, according to age and gender. methods: this prospective clinical study was conducted between january 2019 and april 2019 at a tertiary health facility. nasal tip resistances in 4 different age groups, as 20-29, 30-39, 40-64 and 65 years and older, were measured with a digital newton meter. a total number of 159 patients with a minimum of 36 patients in each age group were included in the study. nasal tip resistance measurements were compared among nasal tip displacement distances of 2mm, 3mm and 4mm, according to age groups and gender.


Eligibility criteria:
inclusion criteria: * four groups were formed as 20-29, 30-39, 40-64 and 65 years and older. a total of 159 patients with a minimum of 36 patients in each group were included in the study. exclusion criteria: * patients with a history of nasal trauma, previous nasal surgery (septoplasty, rhinoplasty, tumor surgery), severe deviation of the caudal septum, visible external nasal deviation, and systemic disease affecting the connective tissue were excluded from the study.

Keywords: nasal tip tip support rhinoplasty nasal cartilage age