Kornimate/medical-research-clean huggingface dataset:
effects of gts-21 on smoking behavior and neurocognitive functions

Conditions: Tobacco Use Disorder

Summary: attempts to quit cigarette smoking are often accompanied by negative mood and problems in attention and memory. these effects, in turn, may contribute to smoking relapse. this exploratory/developmental project examines the effects of a novel medication, gts-21, on individuals interested in smoking cessation. it is hypothesized that gts-21 will reduce negative affect, improve cognition and/or reduce smoking relapse in healthy adult men and women who are chronic cigarette smokers.

the project is a clinical trial assessing the effects of gts-21 (an α7 nicotinic receptor partial agonist) on smoking, mood, neurocognition, and neurophysiology, in a small sample of chronic smokers who are currently healthy and interested in smoking cessation. using a double-blind, placebo controlled, parallel group design, 54 (27 women) community smokers who have demonstrated a readiness to quit will participate over a 7 week active trial. subjects will be randomly assigned to active drug or placebo groups. across the study period, participants will undergo repeated neurobehavioral testing, laboratory assessments of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood state and side-effects.

Eligibility criteria:
inclusion criteria: * minimum of 12 years of education * must report typical daily smoking of \> 10 cigarettes/day over the previous year * must report a history of at least 3 years of regular smoking * must provide carbon monoxide measures of at least 6.5 ppm * must report a willingness to quit smoking exclusion criteria: * participants engaged in behavioral and/or nicotine replacement therapies, or assisted quit efforts, within previous 6 months. * must not meet criteria for other substance dependence or major psychiatric disorders. * must be absent chronic medical conditions that might jeopardize health and safety, confound data interpretation or that contraindicate the administration of compounds acting at nachr sites. this list includes disorders with direct effects on neurologic function (e.g., seizure disorders, transient ischemic events, chronic or active hepatic disease), metabolic disorders (e.g., uncontrolled type 2 diabetes), or cardiovascular disease (e.g., hypertension, mitral valve compromise, tachycardia, or irregular heart rates). * must not smoke only cigars, pipes or hookahs or use nicotine products but not cigarettes * must not report current use of nicotine replacement therapies (i.e., occasions of \> 4 h/week during a typical week, even if not used as a cessation aid) * must not have used bupropion within the previous year * must not report any past use (regardless of year) of varenicline * women may not be breastfeeding, pregnant or intending to become pregnant during the study period

Keywords: smoking smoking cessation
effect of addition of dronedarone to standard rate control therapy on ventricular rate during persistent atrial fibrillation (afrodite)

Conditions: Atrial Fibrillation

Summary: the primary objective of this study is to: assess whether the addition of dronedarone to existing conventional rate control therapy leads to a reduced ventricular rate after 1 week in patients with a high heart rate (hr) at rest during atrial fibrillation (af) in comparison to an increase of conventional therapy. the secondary objectives of this study are to compare both study arms with regard to: * ventricular rate after 3 months * number of registered af episodes * number of symptomatic af episodes * severity of af and af-like symptoms * rate of premature study discontinuation * number of symptomatic episodes of bradycardia * incidence of low heart rate (\<60 bpm)


Eligibility criteria:
inclusion criteria: * persistent af with hr \>80 bpm at rest despite treatment with ≤ 2 rate control agents (i.e. beta blocker and/or calcium antagonist - patients using digoxin are eligible) * documented af in the past 24 hours * treated with the following rate control medication: * beta blocker or * calcium antagonist or * beta blocker plus calcium antagonist or * beta blocker plus digoxin or * calcium antagonist plus digoxin * anticoagulant treatment in line with local guidelines exclusion criteria: * incapacitated patients * paroxysmal or permanent af * use of class i or iii anti-arrhythmic drugs in the past 12 weeks * scheduled cardioversion or pulmonary vein ablation * unstable new york heart association (nyha) class iii and all class iv heart failure * av block grade 2 or 3 * known severe renal impairment (serum creatinine \> 180 μmol/l) * known severe hepatic impairment (ast, alt \> 3 x upper limit of normal (uln)) * contra-indication for dronedarone * participation in a clinical drug study in the 3 months prior to inclusion * women of childbearing potential, who do not use adequate contraception * lactating women the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
bioequivalence study of once daily pmr compared to twice daily cilostazol ir tablets in healthy volunteers

Conditions: Intermittent Claudication

Summary: the study is designed to evaluate the bioequivalence and the within-subject variability between the test formulation of extended-release tablet of cilostazol (pmr) administered once daily and the reference formulation of immediate-release tablet of cilostazol (cilostazol) administered twice-daily in normal healthy male and female subjects under fasting conditions.


Eligibility criteria:
inclusion criteria: * must be 18 to 45 years of age, inclusive, at screening. * absence of diseases that could affect the study outcomes. * having a body mass index (bmi) within normal standard limits (18.5 -24.9, inclusive) at screening. * females must have a negative serum pregnancy test at screening. * understanding and willing to participate in the clinical study and able to comply with study procedures and visits. exclusion criteria: * history of bleeding tendency. * use of anticoagulant agent(s) within one (1) month prior to screening. * use of tobacco or nicotine products within six (6) months of screening. * intake of over the counter (otc) or prescription drugs (other than hormonal contraceptives) within two (2) weeks prior to randomization. * on any investigational drug(s) or therapeutic device(s) within thirty (30) days preceding screening; or anticipating use of any of these therapies during the course of the study (other than the study products). * history of substance abuse, such as alcohol, iv drugs, and inhaled drugs, within one (1) year prior to screening. * known history of having acquired immunodeficiency syndrome (aids) or positive pre-study result of infection with human immunodeficiency virus (hiv); known history or positive pre-study hepatitis b surface antigen or positive hepatitis c antibody result within three (3) months of screening. * pregnant or breast feeding. * women of child-bearing potential not using an effective birth control method. women of child-bearing potential are defined as women physiologically capable of becoming pregnant, unless they meet the following criteria: 1. post-menopausal: 12 months of natural (spontaneous) amenorrhea or less than twelve (12) months of spontaneous amenorrhea with serum follicle stimulating hormone (fsh) levels \> 40iu/l, or; 2. six (6) weeks post-surgical bilateral oophorectomy with or without hysterectomy, or; 3. are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g. bilateral tubal ligation, hysterectomy), hormonal contraception (e.g. implantable, injectable, vaginal, patch, and oral), and double-barrier methods. reliable contraception should be maintained throughout the study and for seven (7) days after study discontinuation. * known or suspected hypersensitivity to any ingredient of the study drug(s). * donated blood or lost more than 150 ml of blood within three (3) months prior to randomization or plans to donate blood or plasma within four (4) weeks after completion of the study.

Keywords: peripheral artery disease cilostazol pmr extended-release tablet of cilostazol
laboratory outcome predictors in coronary surgery

Conditions: Left Ventricular Dysfunction; Coronary Artery Bypass Surgery; Tissue Hypoperfusion

Summary: evaluate less employed markers of tissue hypoperfusion as venoarterial carbon dioxide partial pressure difference (δpco2) and estimated respiratory quotient (erq) combined to other classically studied markers as predictive factors of complicated clinical course after cardiac surgery in patients with left ventricular dysfunction.

patients with left ventricular dysfunction are more susceptible to tissue hypoperfusion and presents more frequently both low cardiac output syndrome and systemic inflammatory response, what results in prolonged stay in intensive care unit (icu), and higher mortality rates when compared to patients with normal ventricular function. the early prediction of prolonged icu stay through the detection of tissue hypoperfusion may improve the management of care and decrease morbidity of this particular group of patients. however, classic markers of tissue hypoxia as central venous saturation, base excess, lactate may not be predictors of outcome in cardiac surgery patients with left ventricular dysfunction. the question addressed in this study is if less employed markers of tissue hypoperfusion as as venoarterial carbon dioxide partial pressure difference (δpco2) and estimated respiratory quotient (erq) have predictive value of prolonged icu stay in patients with left ventricular dysfunction submitted to coronary artery bypass surgery.

Eligibility criteria:
inclusion criteria: * adults * left ventricular dysfunction (ejection fraction \< 50%) * patients undergoing coronary artery bypass surgery requiring the use of cardiopulmonary bypass (cpb) exclusion criteria: * renal failure (creatinine clearance lower than 40 ml/min/m2), * hepatic dysfunction * endocrinologic disorders * pulmonary disease * uncontrolled diabetes mellitus * a history of fever or infection within the week before surgery * previous anemia (hemoglobin ≤ 10.0 g/dl)

Keywords: thoracic surgery myocardial revascularization left ventricular dysfunction tissue perfusion prognosis
measuring and monitoring blood glucose levels utilizing non-invasive blood glucose monitoring device

Conditions: Diabetes Mellitus Type 1

Summary: adequate glycemic control in patients with diabetes mellitus (dm) is a desired therapeutic goal that can be achieved with a true non-invasive device offering the likelihood of continuous glucose monitoring. currently, glucose is best monitored by measuring capillary blood from the fingertips, from venous/arterial line blood samples and from a daily calibrated subcutaneous blood glucose monitor (sbgm) which is a source of severe inconvenience and hence, a lack of compliance. thus, the need for non-invasive and easy to operate glucose monitoring in dm patients for strict glycemic control cannot be overemphasized. the glucometer cgm-305 blood glucose readings are accurate and measure blood glucose with an acceptable mean relative error when compared to acceptable invasive blood glucose measurements. the primary objectives of the trial are to determine: 1. the safety of the glucometer cgm-305 in evaluating blood glucose levels 2. the accuracy of the glucometer cgm-305 in evaluating blood glucose levels


Eligibility criteria:
inclusion criteria: * type 1 diabetic patient. * ages: 18 to 65. * signed informed consent. * hba1c of 6%-9% at screening. * males- not involved in active military duty. * females-non-child bearing potential or females of child-bearing potential who have a negative pregnancy test (hcg in blood or urine) within 72 hours of informed consent. exclusion criteria: * active systemic or local infection. * any medical condition that, by the investigator judgment, will increase the risk from hyper and hypo-glycemic experiment: seizures, heart disease, hypoglycemia unawareness etc. * history of malignancy, radiotherapy, or chemotherapy for malignancy (except bcc of the skin)
patient automated text hovering for ibd

Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Summary: this is a 2-arm randomized trial aimed at leveraging behavioral science principles to improve patient engagement between office visits among patients with inflammatory bowel disease (ibd).

crohn's disease (cd) and ulcerative colitis (uc), collectively known as inflammatory bowel disease (ibd), are common chronic gastrointestinal diseases with significant morbidity and decreased quality of life. care for patients with ibd has been transformed by biologic therapies which dramatically improve inflammation and clinical outcomes. as they are delivered through infusion or injection with long intervals between doses, it can be challenging for patients to maintain adherence due to systems issues such as prior authorization and site of service limitations, in addition to traditional reasons for non-adherence such as inertia and present-time bias. despite evidence that high adherence is needed for effectiveness, estimates are as low as 66%. preliminary observations and interviews show that an important gap for providers is lack of knowledge of how their patients are doing between visits. specifically, patients may not adhere to necessary therapy, and physicians are unaware of changes in course of the disease. a large cross-sectional study has shown that patient-reported outcomes are associated with control of the disease, but serially monitoring these measures has not been tested prospectively. a prior study found that assessing symptoms weekly is highly correlated with information collected with a more cumbersome daily diary. this may provide additional data to clinicians to better manage symptoms and therapy. text messaging is an attractive tool to engage with patients due to the high prevalence of cell phones. the investigators will develop and test a new ibd hovering program that improves the care of patients between office visits. the investigators will enroll patients prescribed biologic therapy and provide text message reminders about scheduled infusions or injections that incorporate behavioral science principles such as anticipated regret, precommitment, and reciprocity. the investigators will also have the patient identify a friend or family member to serve as a support partner to encourage adherence and provide assistance as needed. the platform will communicate with patients weekly to ask about the course of their symptoms, send messaging to the feedback partner, and send alerts to physicians as needed.

Eligibility criteria:
inclusion criteria: * diagnosis of crohn's disease or ulcerative colitis * has had at least 2 visits with penn gastroenterology in the past 2 years * currently prescribed a biologic therapy (infliximab, adalimumab, ustekinumab, certolizumab, golimumab, or vedolizumab). of note, this study is not limited to new initiators of these medications. exclusion criteria: * patients will be excluded if they do not have a phone with text messaging.

Keywords: behavioral economics patient engagement remote monitoring
lebrikizumab pen ease of use in participants with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to assess the ease of use of the lebrikizumab pen. participants will use a practice pad to simulate administration of a dose. participants will complete the modified subcutaneous administration assessment questionnaire (msqaaq) following the simulated injection. this study involves one study visit.


Eligibility criteria:
inclusion criteria: * self-report being diagnosed with atopic dermatitis (ad) by a physician and able to provide approximate diagnosis date. * autoinjector or pen naïve \[have not used an autoinjector or pen previously; permissible to have used a pre-filled syringe (pfs) or vial and syringe\]. * willing and able to attend an in-person interview session. * able to complete the protocol requirements. exclusion criteria: * cognitive or physical difficulties that could interfere with ability to understand the training, perform the injection tasks, or complete the study questionnaires as judged by the investigator. * are currently enrolled or have participated in the last 3 months, in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. * is a health care practitioner who is trained in giving injections. * currently pregnant. * known hypersensitivity to any component of lebrikizumab or its excipients. * treatment with a live (or live attenuated) vaccine within the past 12 weeks. * current or chronic infection with hepatitis b, hepatitis c, or human immunodeficiency virus (hiv) per participant self-report.

Keywords: eczema
comparison of erector spina plan block and rhombodid intercostal block in breast surgery

Conditions: Postoperative Pain; Analgesia

Summary: in this study, the investigators compared ultrasound-guided erector spinae plane (esp) block and rhomboid intercostal block (rib) on postoperative analgesic effect in unilateral breast surgery.

after being informed about the study and potential risks, written consent was obtained from all patients.patients who meet eligibility requirements will be randomized in a 1:1 ratio to erector spinae plane block and rhomboid intercostal block.

Eligibility criteria:
inclusion criteria * patients who will undergo unilateral breast-conserving surgery (bcs) or modified radical mastectomy (mrm) with or without axillary lymph node dissection * patients undergoing elective surgery * asa (american society of anesthesiologists) physical status classification i-iii exclusion criteria: * use of anticoagulants * allergy to the medications to be used * patients who use analgesic drugs due to a history of chronic pain * asa (american society of anesthesiologists) physical status classification iv-v * patients with psychiatric disorders * presence of infection in the area where the block will be applied * presence of deformity in the patient's spinal, paraspinal and area where the block will be applied * the patient does not accept the block application or cannot cooperate with the patient

Keywords: regional anesthesia erector spinae plane block rhomboid intercostal block breast surgery
xylocaine to freeze during unpleasant nasopharyngeal swabs

Conditions: Covid19

Summary: since the beginning of the covid-19 pandemic, nasopharyngeal swabs (nps) have been recommended to detect the virus. this procedure has been reported to be painful by 85% of children the aim of the study was to assess whether pretreatment with topical lidocaine reduces the discomfort experienced by children during a nasopharyngeal swab. this was a rct among children aged 8-17 years old who need a nps. the primary outcome was pain intensity as measured by the visual analog scale .


Eligibility criteria:
inclusion: * 6-17 years old inclusively * children for whom a nps was ordered exclusion: * children presenting with the following acute conditions, which could either prevent the lidocaine from being properly administered, or pose a risk for the patient as increased absorption of the medication might occur: * nasal or airway burns, trauma or major anomaly * cardiorespiratory compromise * children for whom an informed consent could not be obtained * any other life-threatening condition or priority one patient requiring emergency support * language barrier * children presenting with conditions that could prevent their ability to reliably report their pain: * severe intellectual disability * severe pain upon presentation * administration of opiates prior to the nps * children presenting with the following chronic conditions, which could either prevent the lidocaine from being properly administered, or pose a risk for the patient: * hypersensitivity/allergy to the medication or a known component * methemoglobinemia * g6pd deficiency * familial malignant hyperthermia * pseudocholinesterase deficiency * severe hepatic impairment * severe cardiac condition or use of antiarrhythmic medication * risk of airway aspiration
patient reported symptoms in ovarian cancer (precision)

Conditions: Ovarian Cancer

Summary: this multicenter, observational, prospective study will include approximately 20 us-based centers, and approximately 142 patients diagnosed with epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma, whose disease has recurred \> 6 months after first-line platinum-based chemotherapy (first recurrence). patients who have completed second-line chemotherapy and are currently in observation or undergoing bevacizumab maintenance treatment will be eligible to participate in the study.


Eligibility criteria:
inclusion criteria: * histologically documented ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma that has recurred \> 6 months after platinum-based chemotherapy * this must be the first recurrence of the epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma * are at least two weeks but no more than 3 months after the completion of second-line cytotoxic chemotherapy * are currently under observation or being treated with bevacizumab as a second-line maintenance therapy * have a valid email address and access to the internet * provide voluntary written informed consent * speak and read english fluently exclusion criteria: * current participation in a blinded clinical trial for ovarian cancer treatment. (participation in a trial involving only supportive care medicines and/or growth factors is acceptable) * another primary diagnosis of cancer in a different site