Kornimate/medical-research-clean huggingface dataset:
vtx002 versus placebo for the treatment of moderately to severely active ulcerative colitis

Conditions: Colitis, Ulcerative

Summary: this is a study to understand if taking vtx002 daily as a tablet orally is safe and effective in participants diagnosed with moderate to severe ulcerative colitis (uc). approximately 189 participants will take vtx002 dose a, vtx002 dose b, or matching placebo, once daily. the study consists of a 28-day screening period (to see if a participant qualifies for the study), a 13-week double-blind period (a participant receives either active dose a, dose b or placebo), a long-term extension (lte) treatment period of up to 39 weeks, an open-label extension (ole) treatment period of up to 143 weeks, and a 2-week follow-up period. the maximal duration of treatment including the induction period, lte and ole will be 36 months.

this is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of vtx002 in subjects with moderately to severely active uc following daily oral administration of vtx002 as a tablet. approximately 189 eligible subjects will be randomized in a 1:1:1 ratio to receive vtx002 dose a, vtx002 dose b, or matching placebo, once daily (approximately 63 subjects per treatment group). the study consists of a 28-day screening period, a 13-week double-blind induction treatment period (including 7 days of titration followed by 12 weeks of treatment at the assigned dose), a long-term extension (lte) treatment period of up to 39 weeks, an open-label extension (ole) treatment period of up to 143 weeks, and a 2-week follow-up period. the maximal duration of treatment including the induction period, lte and ole will be 36 months. objectives primary objective • assess the efficacy of vtx002 when administered for 13 weeks on clinical remission secondary objectives * assess the efficacy of vtx002 when administered for 13 weeks on endoscopic changes, symptomatic response and remission, histology, and mucosal healing * assess the safety and tolerability of vtx002 * assess the pharmacokinetics (pk) of vtx002 long-term and open-label extension objectives * assess the efficacy of vtx002 through the lte and ole treatment periods on endoscopic changes, symptomatic response and remission, histology, and mucosal healing * assess the safety of vtx002 through the lte and ole treatment periods

Eligibility criteria:
inclusion criteria: * diagnosed with uc ≥ 3 months prior to screening. * active uc confirmed by endoscopy exclusion criteria: * severe extensive colitis * diagnosis of crohn's disease (cd) or indeterminate colitis or the presence or history of a fistula consistent with cd * diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Keywords: s1p; sphingosine 1 phosphate receptor; ventyx; oppilan; moderate or severe ulcerative colitis
supraclavicular block vs retroclavicular block: incidence of phrenic nerve paralysis

Conditions: Phrenic Nerve Paralysis

Summary: the aim of this study is to evaluate differences between ultrasound guided supraclavicular versus retroclavicular brachial plexus blocks: two similar brachial plexus nerve block techniques that differ in their needle trajectory and injection site.

to date, there has not been a study that has compared clinically the retroclavicular brachial plexus block to the supraclavicular brachial plexus block or other brachial plexus blocks. the aim of this study is to evaluate differences between ultrasound guided supraclavicular versus retroclavicular brachial plexus blocks, with primary focus on the incidence of diminished ipsilateral hemidiaphramatic excursion (ipsilateral phrenic nerve blockade). we will also evaluate differences between the two techniques in the success of producing surgical anesthesia, procedural time to perform the block (including imaging time and needling time), block onset time, ease of quality ultrasound needle visualization, and incidence of paresthesias, vascular puncture and pneumothorax. lastly, we will observe and compare the distribution of motor and sensory blockade of the two techniques

Eligibility criteria:
inclusion criteria: 1. patients scheduled for lower arm surgery 2. patients aged 18 years or older 3. patients asa class i-iii exclusion criteria: 1. patients unable to cooperate or consent to the study 2. pre-existing neuropathy 3. significant pulmonary disease 4. contralateral phrenic nerve or diaphragmatic dysfunction 5. allergy to local anesthetics 6. infection at needle insertion site 7. history of coagulopathy 8. bmi \> 40 kg/m2

Keywords: retroclavicular supraclavicular diagphram hemiparesis nerve block regional anesthesia anesthesiology
effect of remote ischemic preconditioning on cardiac function after cardiac surgery

Conditions: Atrial Fibrillation; Ventricular Arrythmias; Myocardial Injury; Cardiac Function

Summary: the purpose of this study is to evaluate the effects of remote ischemic preconditioning on cardiac function in patients undergoing cardiac surgery compared to control intervention.

in detail, we will focus on new onset of atrial fibrillation, ventricular arrhythmias, myocardial injury, and cardiac function. furthermore, we aim to investigate underlying pathways of ripc in modifying the perioperative stress response.

Eligibility criteria:
inclusion criteria: * patient undergoing heart surgery on cardiopulmonary bypass exclusion criteria: * emergency cases * myocardial infarction up to 7 days prior to enrollment * ejection fraction less than 30% * inability to give informed consent

Keywords: ischemic preconditioning cardiac surgery
intravenous tedisamil in the rapid conversion of atrial fibrillation or flutter to normal sinus rhythm in female subjects

Conditions: Atrial Fibrillation; Atrial Flutter

Summary: the purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (nsr) in female patients.


Eligibility criteria:
inclusion criteria: * willing to sign informed consent before screening examinations are performed and before the study drug is administered * females \> 18 years of age * subjects with documented (60 second rhythm strip) symptomatic atrial fibrillation or flutter (duration \> 3 hours and \< 45 days) at the time of randomization * subjects who are in no distress and hemodynamically stable (supine systolic blood pressure \> 90 mmhg and diastolic blood pressure \< 105 mmhg) exclusion criteria: * pregnancy and lactation * acute myocardial infarction and cerebrovascular accidents * coronary syndromes and congestive heart failure (chf) new york heart association (nyha) iv * life-threatening ventricular arrhythmias and electrocardiogram (ecg) abnormalities * concurrent antiarrhythmic treatments

Keywords: atrial fibrillation atrial flutter anti-arrhythmic agents conversion to normal sinus rhythm
virtual white boards for patient satisfaction

Conditions: Satisfaction, Patient; Covid19; Emergencies; Satisfaction; Information Disclosure

Summary: communication with patients on their clinical status is important in delivering care in the emergency department. during times of high volume or complex patients, there may be lapses in communicating with patients about their hospital course or plans of action. these miscommunications may be enhanced during the current covid-19 pandemic as there is minimized in-person interaction with patients in order to conserve personal protective equipment and decrease the risk of disease transmission. this study utilizes a virtual white board to deliver updates to patients about the status of their emergency department stay.

the ultimate goal of this study is to understand the effect of delivering timely information about a patient's emergency department course of their satisfaction surrounding the emergency department stay. the experience of patients in the emergency department has been significantly altered by the covid-19 pandemic due to decreased in-person encounters, and the use of ppe. delivering information about their clinical course and expected hospital course is more difficult now given the emphasis on less in-person interaction. in response, the investigators have deployed in collaboration with e-ink, a virtual e-paper white board that can be remotely edited to help display pertinent hospital course information to patients in the emergency department. the investigators will conduct a randomized controlled trial to understand the effect of deploying these white boards on patient satisfaction in the emergency department.

Eligibility criteria:
inclusion criteria: * patients in emergency department at brigham and women's hospital * triaged to designated emergency department pods outfitted with virtual white board * expected emergency department stay of at least four hours * able to speak and read english * not primary psychiatric complaint exclusion criteria: * medically ill or otherwise deemed unable to participate by the study pi and/or treating clinical team. * patients admitted to an inpatient bed but boarding in the emergency department over 10 hours. * previously participated in the study. * has covid-19 risk flag or confirmed covid-19 in electronic health record
evaluation of primary congenital glaucoma at asyut university hospital

Conditions: Primary Congenital Glaucoma

Summary: evaluation of the management of primary congenital glaucoma regarding the results of surgical intervention at asyut university hospital


Eligibility criteria:
inclusion criteria: typical symptoms of epiphora , photophobia and blepharospasm corneal diameter \> 13 mm increased ocular tension \> 25 mmhg uga using schiotz tonometer exclusion criteria: infants with history of previous surgery secondary glaucoma glaucoma associated with other congenital anomalies
bronchial infection in patients with copd and frequent exacerbations.

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: hypothesis: 1. innate immunity is altered in certain patients with copd and frequent exacerbations, a fact that makes them more susceptible to being infected by bacteria. 2. the electronic nose is able to detect patterns of specific vocs for exacerbations of infectious origin.

bronchial infection has been described as the leading cause of copd exacerbations. different studies with invasive endoscopic techniques have demonstrated the presence of bacteria in the air in 40-70% of exacerbations of the disease. in addition, these patients have a higher concentration of cells and proinflammatory cytokines in the airway. this increased inflammation is associated with more frequent and more severe exacerbations, which worsen this vicious circle. it is not known why some patients with copd are more susceptible than others to bronchial, acute or chronic infection. recent studies have suggested the importance of lung innate immunity, both humoral (proteins with antibiotic activity, inflammatory mediators) and cell (neutrophils, macrophages) as the key to the defense of the lung against infectious agents external factor. there may be a bidirectional relationship between immune response and bronchial infection in copd exacerbations. te main objectives of our study are: 1. to study the expression of mucin, pam and tlr in the airway of patients with copd and frequent exacerbations (fe) and its relationship with the infection of the airway. 2. determine the patterns of volatile organic compounds (vocs) detected by electronic nose associated with bronchial infection in patients with copd and fe. secondary objectives: 1. to study the relationship between the expression of mucin, pam and tlr with pulmonary and systemic inflammation. 2. to study the relationship between the expression of mucin, pam and tlr with bronchial bacterial load. 3. to study the expression of mucin, pam and tlr at the time of copd exacerbations and subsequent clinical phase stability. 4. determine voc patterns for specific pathogens (h. influenzae, s. pneumoniae, p. aeurginosa). 5. to study the time evolution of patterns of vocs after a copd exacerbation.

Eligibility criteria:
inclusion criteria: 1. diagnosis of copd according to national and international guidelines. 2. presence of ≥ 2 exacerbations requiring admission in the last 12 months. 3. signature of informed consent. exclusion criteria: 1. presence of other lung diseases 2. terminal concomitant disease
optimized biventricular pacing allograft recipients

Conditions: Dilated Cardiomyopathy; Ischemic Cardiomyopathy

Summary: this study tests optimization of biventricular pacing (bivp) in patients with dilated cardiomyopathy (dcm) or ischemic cardiomyopathy (icm) during cardiac transplantation in patients with advanced cardiac failure. it examines the effects of atrioventricular delay (avd), interventricular delay (vvd or rld), and left ventricular pacing site (lvps) on cardiac output (co). bivp results are compared to traditional atrial (aai) pacing at an identical heart rate.

this study is designed to increase the benefit of biventricular pacing (bivp), which is an established therapy for advanced heart failure. the investigators will test 6 left ventricular (lv) pacing sites and 16 timing sequences in the operating room just before cardiac transplant. pacing will be implemented after patients have been anticoagulated and connected to the heart-lung machine. pacing by previously implanted pacemakers will be suppressed. the investigators will measure cardiac output (co) by aortic flow probe (afp), left ventricular (lv) contractility by a combination of trans-septal pressure gradients, and simultaneous left ventricular pressure (lvp)and transesophageal echocardiography (tee) during transient reduction of inflow of blood to the heart by vena caval occlusion. the goal is to prove that this optimization will increase the amount of blood pumped by the failing heart by 15% as compared with standard atrial (aai) pacing. the testing protocol is 12.5 minutes in duration, and the entire protocol should be executable in 20 minutes. care will not be altered otherwise. results will improve management of the general population of patients with advanced heart failure while minimally increasing the risk to patients undergoing cardiac transplantation. benefits of this study should include: improved patient selection for bivp and a decrease in the presently recognized 30-40% incidence of bivp nonresponders.

Eligibility criteria:
inclusion criteria: * new york heart association (nyha) heart failure class iii/iv * left ventricular ejection fraction (lvef) \<36% * qrs \>120 msec exclusion criteria: * intracardiac shunts * sinus tachycardia \>120 bpm * second or third degree heart block * previous cardiac surgery * mechanical circulatory assistance * atrial fibrillation

Keywords: biventricular pacing dilated cardiomyopathy ischemic cardiomyopathy congestive heart failure cardiac allograft cardiac surgery avd vvd lv pacing site pacing optimization
a phase 2, open-label, randomized, parallel group, placebo-controlled, single-center study to assess anti-microbial efficacy and safety of dcn01 compared to unisol® following topical periocular administration in healthy volunteers

Conditions: Ocular Infection

Summary: this proof-of-concept study evaluates the clinical efficacy and safety of dcn01 in prepping of the periocular region.


Eligibility criteria:
inclusion criteria: * have given a written, informed consent * be willing and able to follow all instructions * a negative urine pregnancy test if female of childbearing potential exclusion criteria: * known sensitivities to study medication or its components * any signs of an active infection * use of disallowed products during the period indicated prior to the enrollment or during the study * be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test * have a condition or a situation which, in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation

Keywords: dcn01 ocular surgical preparation prophylaxis against infection pre-operative prep
the study of the effects of vitamin a on immune system in patients with atherosclerosis

Conditions: Atherosclerosis

Summary: the aim of this study is the comparison between the effects of supplementation with 25000 iu preformed vitamin a (retinyl palmitate) or placebo for 3 months on immune system and th1/th2 balance in patients with and without atherosclerosis (documented with angiography).

atherosclerosis, the leading cause of death and disability in the world, is considered an inflammatory disease with a complex etiology. the immune system has a prominent role in the formation, development and destabilization of atherosclerotic plaques. a whole range of identified cytokines have been shown to play a part in atherogenesis, some with proatherogenic properties while others having antiatherogenic properties. with increasing evidence for the significant role of inflammation and the cytokines involved together with the th1/th2 imbalance in atherosclerosis and its progression to coronary artery diseases (cads), the control of cytokine production may become potential therapeutic targets and modulation of the th1/th2 balance may provide a new pharmacological tool to treat this disease. vitamin a (va) or va-like analogs known as retinoids, are potent hormonal modifiers of type 1 or type 2 responses but a definitive description of their mechanism(s) of action is lacking. high level dietary vitamin a enhances th2 cytokine production and iga responses, and is likely to decrease th1 cytokine production. retinoic acid inhibits il 12 production in activated macrophages, and ra pretreatment of macrophages reduces ifnγ production and increases il4 production in antigen primed cd4 t cells. supplemental treatment with vitamin a or retinoic acid (ra) decreases ifnγ and increases il5, il10, and il4 production. thus, vitamin a deficiency biases the immune response in a th1 direction, whereas high level dietary vitamin a may bias the response in a th2 direction.

Eligibility criteria:
inclusion criteria: * the criteria for enrollment of the patients and control subjects is consecutive patients of both sexes referred to the division of cardiology of the one of the hospitals of tehran university of medical sciences for coronary angiography for investigation of chest pain and/or suspected cad. exclusion criteria: * patients who have diseases which affect on th1/th2 balance such as asthma, active viral infections, and autoimmune diseases, or * patients who have allergy to vitamin a compounds, or * patients who have used vitamin supplements in last 3 months.

Keywords: atherosclerosis coronary artery disease vitamin a cd4-positive t-lymphocytes th1 cells th2 cells
efficacy of shotblocker in spinal needle related pain

Conditions: Needle Phobia; Spinal Anesthesia; Pain

Summary: this was a single-blind, randomized controlled trial. seventy-six patients who underwent spinal anesthesia for surgery were randomized into the shotblocker group or control group. before the insertion of a 25-gauge spinal needle, shotblocker was applied just before the spinal needle insertion in the shotblocker group. 10-cm visual analog scale to evaluate the pain intensity of spinal needle insertion and a five-point scale for patient satisfaction were compared between the two groups.


Eligibility criteria:
inclusion criteria: * patients undergoing surgery exclusion criteria: * contraindications to regional anesthesia * refusal of the patient's regional anesthesia * intellectual disabilities that prevented completion of a visual analog scale (vas)
glypican4 and ctrp5 in metabolic syndrome and the effect of exercise on these adipokines

Conditions: Metabolic Syndrome; Obesity

Summary: glypican4, ctrp3, ctrp5 are emerging novel adipokines mediating obesity and inflammation related disorders. rbp4 and adiponectin are well known important adipokines. therefore, we examine the circulating levels of theses adipokines in the subjects with or without metabolic syndrome. furthermore, we tried to clarify the effect of exercise on the circulating these adipokines.


Eligibility criteria:
inclusion criteria: * women between 30 and 60 years of age who had a body mass index (bmi) more than 25 kg/m2 * the subjects of metabolic syndrome and age, gender matched non metabolic syndrome among the participants of korean so study (ksos) study, which is an ongoing epidemiologic study supported by the korea science and engineering foundation exclusion criteria: * participants had a history of cardiovascular disease * any type of diabetes * stage 2 hypertension * malignant disease, severe renal, or hepatic disease * subjects taking medications that might affect body weight or body composition
maternal metabolic and molecular changes induced by preconception weight loss and their effects on birth outcomes

Conditions: Obesity; Familial; Pregnancy Related

Summary: our hypothesis is that aggressive preconception weight loss in obese women will improve the metabolic health of the mother and the intrauterine environment. an optimized developmental environment will normalize fetal growth and improve clinical fetal and infant outcomes, and theoretically reduce future susceptibility to obesity and cardiometabolic disease.

further, our hypothesis is that the metabolic profiles in the mother and infant cord blood and epigenetic profiles in cord blood leukocytes will be improved in the very-low energy diet (vled) group compared to standard practice nutrition counseling and support (soc) group and approach the profiles found in normal weight (lean) individuals. we will relate these changes to the changes in the offspring clinical profiles. with these data in hand, we will develop a model to understand the potential molecular markers associated with offspring size and adiposity at birth, risk factors for later onset non-communicable diseases. we will use these insights to define, adopt and implement future interventions that mitigate the downstream risk of adiposity and cardiometabolic diseases.

Eligibility criteria:
inclusion criteria: * bmi \> 30 ≤ 45 for obese participants or * bmi ≤ 25 for healthy body weight participants * no known infertility * no known risk factors for tubal disease exclusion criteria: * significant medical co-morbidities (e.g. heart, kidney, liver, autoimmune disease) * significant anemia * cancer other than minor skin cancers * conditions that would complicate pregnancy * recent use of anti-obesity drugs or appetite suppressants * previous bariatric surgery * endometriosis afs (american fertility society classification class iii or iv) * progesterone \> 10 iu/ml * current pregnancy * use of sperm donor
catheter ablation and rate control of atrial fibrillation in patients with heart failure

Conditions: Catheter Ablation; Rate Control; Heart Failure; Atrial Fibrillation

Summary: to evaluate the efficacy of catheter ablation and rate control in heart failure patients with atrial fibrillation.

all patients received either catheter ablation for rhythm control or rate control before enrollment, and the investigators do not assign specific interventions to the subjects during the study. so this study might be considered to be observational.

Eligibility criteria:
inclusion criteria: * age\>18 years * documented atrial fibrillation * new york heart association ⅱ-ⅳ or left ventricular ejection fraction \<50% exclusion criteria: * heart failure that had a suspected reversible cause * previous ablation * any contraindication to catheter ablation