Kornimate/medical-research-clean huggingface dataset:
impact of left bundle branch area pacing vs. right ventricular pacing in atrioventricular block (leap-block)

Conditions: Atrioventricular Block; Left Bundle Branch Area Pacing; Right Ventricular Pacing; Heart Failure

Summary: this is a multicenter, randomized controlled study. the aim of this study is to compare the impact of lbbap on left ventricular function as compared with traditional right ventricular pacing in patients with atrioventricular block.

leap-block is a prospective, multi-center, randomized controlled trial that is designed to determine whether left bundle branch area pacing (lbbap) may reduce the risk of rv ventricular pacing induced cardiac dysfunction as compared with traditional rv pacing (rvp) in patients with atrioventricular (av) block and normal lv function (lvef≥50%) who require high percent of ventricular pacing. the primary aim of this trial is to compare the time to first event (composite of all-cause mortality and newly heart failure hospitalization and device upgrade due to heart failure) between lbbap and rvp group in patients with av block. patients with av block and normal lv function who require high burden of ventricular pacing (expected \>40%) will be randomized to lbbap or rvp group for therapy. patients will be followed at least every 3 months for clinical status and every 6 months for echocardiographic evaluation until the study closure.

Eligibility criteria:
inclusion criteria: * a. adult patients aged 18-90; * b. av block patients with ventricular pacing indications and the expected rate of ventricular pacing(vp)\> 40%, including (a)third-degree av block; (b) second degree av block (type ii); (c) intermittent advanced av block with expected vp\>40%; (d)symptomatic first degree av block and pr interval on ecg ≥ 250ms; * c. the subject is able to receive a pectoral implant; * d. the subject is willing and able to comply with the protocol; * e. the subject is expected to remain available for follow-up visits at the study centers. * f. subject or authorized legal guardian or representative has signed and dated the study subject informed consent exclusion criteria: * a. baseline echocardiographic assessment of patients with impaired lv function (lvef\<50%); * b. having difficulties in follow-up: those who cannot accept 2-year follow-up on time due to physical condition or other reasons; * c. patients with persistent atrial fibrillation; * d. pacemaker replacement without new implanted ventricular electrodes; * e. patients with implantable cardioverter-defibrillator (icd) indications; * f. surgery is required within 1 year due to severe structural heart disease; * g. patients with tricuspid mechanical valve replacement, or congenital heart disease (including transposition of the great arteries, or permanent left superior vena cava, etc), or av block resulting from: (a) hypertrophic cardiomyopathy(hcm)vpost (modified) morrow surgery, (b) ventricular septal defect repair; and those who are unlikely to achieve successful lbbap procedure.

Keywords: atrioventricular block left bundle branch area pacing right ventricular pacing
comparing tissue adhesives in port site closure

Conditions: Dermatitis, Contact

Summary: this is a multi-center randomized controlled trial to evaluate two different methods of reinforcing surgical port site closure: 2-octylcyanoacrylate and n-butyl-2-cyanoacrylate.

study design this is a multi-center randomized controlled trial to evaluate two different methods of reinforcing surgical port site closure: 2-octylcyanoacrylate and n-butyl-2-cyanoacrylate. methods inclusion criteria all adult patients undergoing an elective laparoscopic or robotic abdominal surgery with the minimally invasive surgeons of texas (mist) either at texas medical center or sugar land will be eligible. exclusion criteria 1. patients unlikely to follow-up (live out of state, unable to be reached by phone or email) 2. patients with a known allergy to 2-octylcyanoacrylate or n-butyl-2-cyanoacrylate. treatment groups eligible patients will be approached by research staff either in clinic or in pre-operative holding for trial enrollment. each patient will serve as their own control. enrolled patients will have both surgical glue types used, one on each half of their abdomen. the side for each glue will be randomly assigned by the day of the month. on odd days, 2-octylcyanoacrylate will go on the patient's left abdomen. on even days, 2-octylcyanoacrylate will go on the patient's right abdomen. if there is an odd number of incisions, the extra incision will be included on the patient's left. all incisions will be closed with monocryl. closed incisions will be covered with skin glue. outcome the primary outcome of this trial will be the proportion of patients with contact dermatitis within 6 weeks post-operative. a trained surgical clinician blinded to the treatment arms will collect outcomes at all follow up clinic visits in the first 6 weeks post-operative. any skin reaction will be documented with photographs. secondary outcome will include the diameter of erythema around any skin reaction, or any wound dehiscence or surgical site infection.

Eligibility criteria:
inclusion criteria: * 18 or older * undergoing an elective laparoscopic or robotic abdominal surgery exclusion criteria: * patients unlikely to follow-up (live out of state, unable to be reached by phone or email) * patients with a known allergy to 2-octylcyanoacrylate or n-butyl-2-cyanoacrylate.

Keywords: glue surgical glue dermabond dermatitis
hormonal stimulation of spermatogenesis

Conditions: Azoospermia, Nonobstructive

Summary: urologists and reproductive specialists are often challenged when facing patients with severe male infertility scenarios. in particular, the treatment of men with noa demands a deeper insight. in such cases, .

the hormonal stimulation of spermatogenesis is still being explored. thus, there is still little knowledge regarding the type of patient who might benefit from medical treatment, the optimal medication, the regimen, and the duration of treatment. in male infertility, the induction for treatment with follicle stimulating hormone (fsh) in the induction and maintenance of spermatogenesis in patient with hypogonadotopic hypogonaism. as these patients are normally azoospermic without gonadotropin stimulation and during testosterone therapy the presence of high numbers of progressively motile and normally formed sperms in the ejaculate during exogenous gonadotropin therapy might result in the desired clinical pregnancy for many infertile couples on an experimental basis and in some places already in clinical routine. fsh preparation are also used for treatment of normogonadotopic infertile men with idiopathic impairment of spermatogemesis. pulstile gnrh or exogenous gonadotropins are usually used to induce spermatogenesis and promote testicular enlargement .the regimen for gonadotropin replacement includes an initial use of human chorionic gonadotropin (hcg) for 6 to 12 months and then addition of fsh or human menopausal gonadotropins (hmg) until pregnancy

Eligibility criteria:
inclusion criteria: * men with primary infertility due to non-obstructive azoospermia in two seminal analysis exclusion criteria: 1. patients with non-obstructive azoospermia with normal or low level of fsh. 2. patients with serum testosterone lower than 3 nmol/l.
the 5 repetitions sit-to-stand test, carried out remotely via videoconference, in patients with copd: is there a learning effect?

Conditions: Chronic Respiratory Disease

Summary: the purpose of this clinical study is to determine if a learning effect exists when the 5sts is assessed remotely via videoconference in patients with copd.

pulmonary rehabilitation (pr) is an essential therapy for improving exercise tolerance and quality of life in patients with chronic respiratory disease. it is now available remotely thanks to advances in information and communication technologies. pulmonary telerehabilitation facilitates care access for patients living far from specialized centers. it requires, for a complete and coherent transposition, to be able to evaluate the patients remotely in order to measure the evolution of their functional capacities and to ensure their follow-up. among the tests already implemented at home and remotely via video-conference, the 5-repetition sit-to-stand test (5sts) is the most suitable. this test requires only a short time to perform, little space and no specific equipment. however, two major limits remain to be checked before being able to consider its remote and routine implementation. first of all, it is important to study its feasibility. moreover, like other functional tests, it raises the question of a possible learning effect (le). in the perspective of a current use of the 5sts remotely, it is therefore also essential to assess the existence of a potential le which would condition the methods of administering the test and its interpretation.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of chronic obstructive pulmonary disease (copd) * obtaining oral informed consent after a minimum reflection period of 24 hours * patient with internet access at home and a tool allowing the realization of a videoconference (smartphone or computer) exclusion criteria: * patients who had a recent exacerbation (less than 4 weeks) * patients physically unable to get up from a chair and sit down without help * patients with significant and unstable cardiovascular disease * any acute or chronic pathology (orthopedic, neurological, psychiatric or causing a major cognitive disorder) limiting the performance of a functional test * inability or difficulty using digital tools * subjects in a period of relative exclusion compared to another protocol * adults protected by law or patient under guardianship or curatorship * subjects deprived of liberty by a judicial or administrative decision * current or planned pregnancy during the study period * pregnant or breastfeeding women * patients not affiliated to a french social security scheme or not benefiting from such a scheme
oral hygiene compliance in orthodontic patients using active reminders

Conditions: Oral Hygiene; Dental Plaque

Summary: the aim of the present study will be to determine if different forms of active reminders regarding oral hygiene compliance have an influence on the level of compliance within orthodontic patients


Eligibility criteria:
inclusion criteria: * subjects with a complete natural dentition. * patients who need to undergo orthodontic therapy using fixed appliances. * good oral hygiene, with no signs and symptoms of periodontal disease. * patients with no medical or mental problems. exclusion criteria: * patients with health risks associated with periodontal probing. * syndromic patients ex; down syndrome. * previous orthodontic treatment. * patients with carious teeth
false lumen treatment for prevention of aortic growth using shape memory polymer - first-in-human study (flagship_fra)

Conditions: Aortic Dissection

Summary: to determine the safety and feasibility of investigational product to reduce aortic dissection false lumen perfusion.


Eligibility criteria:
inclusion criteria: * ≥18 years of age. * a candidate for false lumen (fl) embolization with a type b dissection, and no prior primary entry tear/tl treatment, or * a candidate for fl embolization with a type b or type a dissection, in whom the primary entry tear/tl was treated in a previous procedure, and is now presenting with a fl requiring treatment. exclusion criteria: * an inability to provide informed consent. * enrolled in another clinical study other than a registry. * hyperacute or acute aortic dissection (\<15 days from symptom onset). * untreated or uncovered primary entry/reentry tear proximal to left subclavian artery (before fl treatment with the investigational product). * vascular disease, aortic rupture, and/or anatomy and/or dissection membrane condition that precludes the safe access and positioning of an introducer sheath and delivery (and expansion) of the investigational product into the fl. * prior treatment of the fl. * planned use of investigational devices to treat the primary entry tear and/or tl. * absence of/inability to create a reentry tear/fenestration adequately positioned and large enough to allow introducer sheath access into the fl. * planned use of fl embolic devices other than the investigational product. * prior abdominal aortic aneurysm (aaa) treatment. * planned concomitant major surgery (e.g., gastrointestinal surgery). * diagnosed or suspected congenital degenerative connective tissue disease (e.g., marfan's or ehler-danlos syndrome). * coagulopathy or uncontrolled bleeding disorder. * serum creatinine level \>2.5 mg/dl (within 90 days prior to the procedure). * cerebrovascular accident within 90 days prior to the procedure. * myocardial infarction and/or major heart surgery within 90 days prior to the procedure. * atrial fibrillation that is not well rate controlled. * unable or unwilling to comply with study follow-up requirements. * life expectancy of \<2 years postprocedure. * known hypersensitivity or contraindication to platinum, iridium, or polyurethane. * a condition that inhibits radiographic visualization during the study procedure and planned follow-up imaging. * history of allergy to contrast medium that cannot be managed medically. * uncontrolled comorbid medical condition, including mental health issues, that, in the opinion of the investigator, would adversely affect participation in the study. * participant is planning to become pregnant or is currently pregnant or lactating. for participants of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the study.
effectiveness of pressure release technique in patients with chronic low back pain

Conditions: Low Back Pain

Summary: a pressure release technique will be test in patient with low back pain compared to a sham


Eligibility criteria:
inclusion criteria: * chronic low back pain at least 6 months exclusion criteria: * hernia, neurologic pain
azd2281 in combination with liposomal doxorubicin in advanced solid tumours

Conditions: Solid Tumors

Summary: the study will be an open label, multicenter, dose finding study. depending on the tolerated dose up to 7 dose levels will be explored in this study, approximately 33 patients (21-54 depending on number of cohorts) may be enrolled into this study. three patients will be initially dosed in each cohort. the primary objective of this study is to determine the recommended dose (rd) of twice daily oral doses of azd2281 either as intermittent therapy for 7 days out of a 28-day schedule or given continuously, administered in combination with liposomal doxorubicin to patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent * measurable or evaluable disease * ecog performance status 0 - 2 * estimated life expectancy of at least 12 weeks exclusion criteria: * more than 3 prior lines of chemotherapy for advanced disease * less than 28 days from active treatment (ie, any treatment used to treat the disease) or high dose radiotherapy (patients may continue concomitant use of stable dose of bisphosphonates if used at least 28 days prior to commencing study treatment and pat * prior treatment with \>300mg/m2 cumulative dose of doxorubicin equivalent * resistance to anthracyclines defined as progressive disease during anthracycline treatment or within 6 months after the last anthracycline administration.

Keywords: advanced tumors solid tumors dose escalation combination azd2281 liposomal doxorubicin pharmacology phase i multicenter
eprotirome for the treatment of dyslipidemia, efficacy and safety 12-week, phase ii study to assess the safety and efficacy of kb2115 in patients with primary hypercholesterolemia

Conditions: Primary Hypercholesterolemia

Summary: eprotirome (kb2115) is a liver selective thyroid hormone that can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the extrahepatic tissue. eprotirome has in a clinical 2-weeks studies demonstrated pronounced reduction of independent risk factors for the development of atherosclerotic cardiovascular diseases. the purpose of the study is to assess the efficacy and safety of kb2115 as monotherapy following 12 weeks of exposure compared to placebo. the aim of the study is to assess efficacy (ldl-cholesterol lowering effects) and safety of kb2115.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of hypercholesterolemia

Keywords: hypercholesterolemia dyslipidemia thyroid safety
managing stress and social ties for health aging

Conditions: Stress

Summary: there has been a dramatic rise from 46% to 59% in the percentage of households with only 1-2 people from 1970 to 2000. a 40% increase in the number of people living alone is projected for 2010. social isolation is consistently one of the strongest predictors mortality in older adults. recent research is demonstrating that stress plays an important role linking social isolation with poor health. socially isolated older adults are more likely to feel chronically stressed and overwhelmed with everyday life demands. furthermore, isolated adults respond to stress differently, both psychologically and physiologically. socially isolated and lonely older adults show long-term elevations in "inflammatory cytokines", which are signaling molecules related by immune cells. these inflammatory cytokines play a role in a number of age-related diseases including cardiovascular disease, type-2 diabetes and arthritis. novel, readily useable interventions aimed at decreasing isolation and "re-calibrating" stress responses might be helpful to older adults. tai chi is an ancient chinese form of calisthenics that promotes relaxation and decreases feelings of stress and as such, it may be a useful intervention for socially isolated, stressed older adults. however, its effects on stress responses are unknown. tai chi chih (tcc) is a simplified, manualized, readily exportable form of tai chi particularly well-suited for older adults. this proposed study will test the effects of a tcc intervention with socially isolated older adults on loneliness, stress and health outcomes, including inflammatory assessment. tai chi-naïve participants who perceive themselves as socially isolated, as measured by the ucla loneliness scale will be randomized to receive either tai chi or education control for a 12-week period. subjects will undergo pre- and post-intervention stress assessment, including exposure to a psychological stress task, to assess whether tai chi affects how subjects physiologically and psychologically respond to stress.


Eligibility criteria:
inclusion criteria: * adults \> 60 years old * have not done tai chi before * live in los angeles area * socially isolated * women must be post menopausal exclusion criteria: * any physical debility that limits tai chi performance; * cognitive impairment (\< 23 on the mini-mental state exam); * current or recent history of smoking * immune suppression resulting from neoplastic disease * corticosteroid use or other therapy * significant underlying illness that would interfere or prevent completion of the study * acute conditions (e.g. viral infection w/in 2 weeks) that might confound interpretation of inflammatory data * current or recent (within 1 month) use of illicit drugs.

Keywords: stress loneliness social isolation autonomic activity inflammation perceived social isolation chronic stress
surgical removal of carotid body in patients with systolic heart failure

Conditions: Systolic Heart Failure; Peripheral Chemoreceptor Hypersensitivity

Summary: the aim of the study is to determine safety, tolerability and feasibility of unilateral and bilateral carotid body excision in patients with systolic heart failure and peripheral chemoreceptor hypersensitivity.


Eligibility criteria:
inclusion criteria: * history of heart failure class ii-iii according to nyha within at least 6 months prior to inclusion * stable clinical state within at least 4 weeks prior to inclusion * subject \>= 18 years old * left ventricular ejection fraction ≤ 45% evaluated by transthoracic echocardiography (simpson's method) * carotid body present in computer cervical angiotomography * history of exacerbated peripheral chemoreceptor sensitivity determined as \>0.6l/min/%spo2 * able and willing to give written informed consent exclusion criteria: * unstable angina pectoris, coronary attack, coronary revascularization, exacerbation of heart-failure requiring hospitalization, clinically significant infection, surgery under general anesthesia within 3 months prior to inclusion * history of stroke, transient ischemic attack (tia), or clinically significant chronic neurological disorder * history of heart transplant * pregnancy or anticipation of pregnancy * hemodialysis or peritoneal dialysis patients * obstructive carotid atherosclerotic disease with \>50% stenosis * severe sleep apnea syndrome diagnosed in psg * copd stage iii and iv according to gold 2007 * unable to perform the spiroergometric assessment * any significant anomaly in additional investigation which may increase the risk of study procedure

Keywords: carotid body heart failure chemoreceptor hypersensitivity
effectiveness of the new perilaryngeal airway in comparison with the laryngeal mask airway

Conditions: Obesity

Summary: the laryngeal mask airway (lma) has been used widely for different patients and found to be highly safe for adult and pediatric patients. however, the lma has some limitations and weaknesses (e.g. more insertion attempts in 5% to 10 % of all cases. despite the easy insertion of the lma, it is crucial to check correct placement of the lma airway.


Eligibility criteria:
inclusion criteria: * bmi between 25 to 35 kg/m2 * scheduled for surgery * being older than 18 years * mallampati class i-iii and bmi between 25 and 35 exclusion criteria: * pregnancy * morbid obese (bmi\>35 kg/m2) * a known difficult airway * gastro-oesophageal reflux * pharyngeal pathology * emergency operation with full stomach
mitochondria and metabolic syndrome in a southern california chinese cohort

Conditions: Metabolic Syndrome; Type 2 Diabetes Mellitus

Summary: there has been increasing support for our hypothesis that mitochondrial dysfunction plays an important role in the etiology of type 2 diabetes mellitus and the overlapping metabolic syndrome.

once the mitochondrial defect(s) of these subjects has been defined, the data will be used to develop two non-invasive screening tools to detect mitochondrial defects in diabetes mellitus and metabolic syndrome patients. the device call diffuse optical spectroscopy develope at beckman laser instituteis is non-invasive measurement technique, to measure the properties of the muscle tisuue and vascular activity (calf, bicep, or the brain)to evaluate the patient's metabolic status and and to assess muscle mitochondrial oxphos function.

Eligibility criteria:
inclusion criteria: * chinese descent and have been clinically diagnosed with diabetes mellitus (dm) or have met the study criteria for metabolic syndrome (ms). exclusion criteria: * non chiness descent

Keywords: mitochondria and metabolic syndrome