Kornimate/medical-research-clean huggingface dataset:
a prospective randomized trial of external vein graft support in surgical myocardial revascularization

Conditions: Heart Attack, Revascularization

Summary: the aim of the thesis is to compare a group of patients using vein grafts with and without external support, specifically their patency. this is a prospective study with a follow-up plan of 150 patients, in whom the functionality of the grafts will be monitored at time intervals.

one of the most frequently used strategies to restore blood flow in affected coronary arteries in atherosclerotic disease is coronary bypass, or bridging of a narrowed or closed artery and revascularization of the ischemic area of the heart. for coronary artery bypass grafting (cabg), the great saphenous vein (vsm) remains the most commonly used graft, although the longevity of the vein graft is an important limiting factor in monitoring long-term results of cabg. long-term follow-up found that 25% of vein grafts close within 1 year of surgery, and up to 75% of vein grafts close 10 years after surgery. external support minimizes pathophysiological processes in the graft. for example, intimal hyperplasia, kinking, graft dilatation or graft suppression and generally improving the hemodynamic flow through the graft should also reduce the formation of thrombus. in this study we follow up the patency and function of vein grafts over a period of 4 years, and compare the resulting data with already available data from other researches.

Eligibility criteria:
inclusion criteria: * elective cardiosurgical revascularization using vsm vein graft, i.e. patients with mvd findings. exclusion criteria: * thromboembolic event in the past, long-term warfarinization, mechanical valves, infection during the procedure, urgent procedure, allergy to contrast material, pregnancy, elevated creatinine. a relative contraindication for exclusion from the study is: vsm varicosity, vsm damage during sampling.the age, gender or weight of the patient has no influence on the indication.

Keywords: heart attack, revascularization
nurse-led bbti for post-stroke insomnia

Conditions: Insomnia

Summary: the current study aims to compare face-to-face and internet-based nurse-led bbti compare to a wait-list conditions in the stroke population. this study is a parallel, three-arm, randomized controlled trial (rct). each participant will be randomized into one of the treatment arms; face-to-face bbti, internet-based bbti, and waiting-list. the bbti, emphasizes behavioral aspects of insomnia care, arises from techniques of sleep restriction and stimulus control. the face-to-face and internet-based bbti have equivalent content based on the standard portion. all participants will be asked to fill the online questionnaires at weeks 0 (baseline), 1 (mid-treatment), 2 (post-treatment), 4, and 12 (follow up). after the final follow-up, the waiting-list participants will be allowed to join the internet-based bbti treatment. our hypotheses are that patients with stroke who receive face-to-face or internet-based bbti, compared to a wait-list condition, will experience fewer insomnia complaints.

post-stroke insomnia is a common complaint with prevalence rates remain high. patients suffering from insomnia following stroke could impair their health-related quality of life and negative rehabilitation outcomes. identifying effective treatment in managing post-stroke insomnia has become clinically relevant. brief behavioral therapy for insomnia (bbti), a 4-section of treatment for insomnia, has similar treatment components with cbti, with the exception of cognitive therapy. previous evidence found that both bbti and cbti have comparable effects on improving sleep quality and consolidation. existing literature has suggested that bbti was effective on mitigating primary and comorbid insomnia. nonetheless, thus far, no study has explored its effects in stroke population. of note, bbti still requires certain contact with therapists. to enhance the widespread dissemination of bbti, it is important to establish the internet-based bbti treatment model (more flexible time schedule) to target more populations with insomnia. the recent study of the online tailored bbti has proven the comparable effects to reduce insomnia severity in the general population. however, no study investigates the efficacy of internet-based nurse-led bbti in the stroke population.

Eligibility criteria:
inclusion criteria: * had diagnosed with stroke for at least 3 months (chronic phase) * had nihss score \< 6 * complain insomnia symptom based on the score of isi\> 7 * having sufficient cognitive function to complete tasks, * able to access to internet exclusion criteria: * the people receiving bbti and other psychological treatment for insomnia * doing shift work * having psychiatric disorders * being pregnant or breastfeeding * having other sleep disorders (e.g., sleep apnea) * drugs or alcohol abuse, * serious or unstable medical condition prior to the study
the effects of autologous fat transfer on preventing expanded skin from expansion failure

Conditions: Scar; Nevus

Summary: the purpose of this study is to evaluate whether autologous fat grafting is safe and/or effective to prevent expanded skin from expansion failure.

the repair of skin defects is a common problem for reconstructive surgeons.soft tissue expansion is a widely used technique for the repair of skin defects. early expansion-related complications such as skin thinning, telangiectasia, and striae may result in expansion failure and ultimately jeopardize final outcome. in the past years, discontinuation of the expansion procedure was the only therapeutic option, when early alarm signs such as semitransparent appearance and telangiectasia of the expanded skin were encountered. we aimed to overcome these complications by therapeutic fat grafting to prevent skin necrosis and enable continuation of the expansion procedure. patients undergoing soft tissue expansion treatment for resurfacing skin lesions including scars and nevi that required therapeutic intervention due to early complication signs were included in this study. patients were randomly divided into treatment group using autologous fat grafting and control group with discontinued expansion and expectant management. the treatment group received autologous fat transfer to the expanded skin.

Eligibility criteria:
inclusion criteria: * expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back; * implanted silicone expander of 50 to 800 ml in size; * history of deterioration in the expanded skin texture that did not improve after the inflation procedure was suspended for more than 2 weeks; * persistent high level of expander internal pressure; * need for further skin expansion; exclusion criteria: * evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy; * rupture of expanded skin, expander exposure; * significant renal, cardiovascular, hepatic and psychiatric diseases; * significant medical diseases or infection (including but not limited to the carrier of hepatitis b virus or hiv); * bmi less than 17 or insufficient subcutaneous fat; * history of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis; * history of allogenic bone marrow transplantation; * pregnant or lactating woman; * long history of smoking; * evidence of malignant diseases or unwillingness to participate

Keywords: fat grafting expansion-related complications
covered or uncovered bile duct stents

Conditions: Bile Duct Neoplasms

Summary: the study is investigator initiated. tumors that gives the narrowing of the bile ducts prevents bile from flowing from the liver to the intestine resulting in jaundice and the risk of bacterial growth in bile with severe infections as a result. unresectable bile duct strictures have routinely been treated them with plastic stents. the plastic stents have been replaced by self expandable metallic stents. these stents remain open longer for reasons that they have a larger diameter so that the bile flows through more easily. one problem with these stents, however, is that the tumor growing through the wire mesh which forms the wall of the stent. this has led to the development of so-called covered stents. whether covered stents have longer patency is unclear as well as whether they are as safe. there is reason to believe that covered stents remain open longer, but there may be an increased risk of migration and other complications. the purpose is to prospectively and randomized compare the two stent types. the study endpoint is the clogging of the stent or the patient's death. we also monitor complications, regress time of the jaundice and success rate of stent placement

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Eligibility criteria:
inclusion criteria: * patients with unresectable, distal bile duct stricture needing relieved endoscopically * expected survival greater than 3 months * the patient must give written consent to participate in the study exclusion criteria: * stricture close to hilus * need for interpreter

Keywords: covered, uncovered, palliative treatment, stent
stamp+cbt mhealth for cancer pain

Conditions: Active Cancer; Active Cancer Treatment; Advanced Cancer; Palliative Care; Chronic Pain Due to Cancer

Summary: the purpose of this study is to test whether a mobile application developed to help people with cancer pain is useful and helpful to patients with cancer.

this research study involves the use of a smartphone app at home in addition to surveys and potentially an interview at the end of the study. the research study procedures include screening for eligibility, study interventions include surveys at the beginning of the study, after 4 weeks, and after 6 weeks and use of the smartphone app. participants will be on this research study for up to 6 weeks. it is expected that about 15 people will take part in this research study this research study is a feasibility study, which is the first-time investigators are examining this mobile application meant to help participant to learn behavioral techniques to manage cancer pain. the purpose is to make sure the app is usable and helpful for patients with cancer, and to get feedback about patient experiences after using the app for four weeks.

Eligibility criteria:
inclusion criteria: - pilot cohort * age ≥ 18 years * patients diagnosed with an active cancer diagnosis, either undergoing active cancer treatment or receiving treatment for an advanced cancer or are receiving palliative care * treatment managed at participating clinic (dfci outpatient palliative care, gastrointestinal cancer center, and dfci satellite clinic merrimack valley or londonderry) * chronic pain related to cancer or treatment (\> pain score of 4) * has an active prescription for at least one opioid medication to treat their cancer pain (i.e. not for post-surgical pain) * own a compatible smartphone (android) or is willing to use an android device provided by the study team * completes baseline survey exclusion criteria: * patients in survivorship: patients who have completed their treatment regimens, are not actively receiving treatment for an advanced cancer, or have a cancer that is in remission * cognitive impairment that would interfere with study participation, as judged by treating clinician * inability to speak english: the intervention has not yet been translated to spanish * history of opioid use disorders * enrolled in hospice * currently hospitalized * use of transmucosal fentanyl, given safety concerns and ongoing risk mitigation program required to prescribe these (tirf rems). * pain primarily related to a recent surgery

Keywords: active cancer active cancer treatment advanced cancer palliative care chronic pain due to cancer
recombinant human c1 inhibitor for the treatment of acute attacks in patients with hereditary angioedema

Conditions: Hereditary Angioedema; Angioneurotic Edema; Genetic Disorders

Summary: hereditary angioedema ("hae") is a genetic disorder characterized by sudden recurrent attacks of local swelling (angioedema). these attacks are often painful and disabling, and, in some cases, life-threatening. "hae" is caused by mutations in the "c1inh" gene that leads to a decrease in the blood level of functional "c1inh". this multi-center study was designed to assess the safety and tolerability, efficacy and pharmacodynamics/ pharmacokinetics of recombinant human c1 inhibitor ("rhc1inh") in the treatment of acute hereditary angioedema attacks.

a prospectively planned interim analysis will be performed on the double-blind data.

Eligibility criteria:
inclusion criteria: * clear clinical and laboratory diagnosis of hae * baseline plasma level of functional c1inh of less than 50% of normal * evidence for exacerbation or development of a severe abdominal, oro-facial/ pharyngeal/ laryngeal, genito-urinary and/or peripheral hae attack exclusion criteria: * acquired angioedema * pregnancy or breastfeeding * participation in another clinical study within prior 3 months
application of the visualization of treatment objective (vto) analyses in fabricating anterior repositioning splints

Conditions: Temporomandibular Joint Disorders

Summary: this study conducted a randomized controlled clinical trial to evaluate the effect of the the therapeutic position of the anterior repositioning splint determined by vto analyse compared with traditional method for the treatment of the anterior disk displacement with reduction of the temporomandibular joint.

a randomised clinical trial was conducted with 20 patients diagnosed with addwr through rdc/tmd and they were randomly allocated into the group 1(traditional group):the therapeutic position of the ars were determinded by the "minimum protrusive position",which was the traditional method to fabricate the anterior repositioning splints;group2(digitial group): the therapeutic position of the ars were determinded by the vto analyse,first,the participants were constructed to take cbct and mri scans,the ideal therapeutic position of the ars were located in which the temporomandibular joint space distribute well and the condylar recapture the disc,the dentist could determine the amount of condylar movement and performed vto analyse by assessing the cbct and mri scans ,then it could easily realize the final condylar movements with the application of the dental articulator. they were followed-up in the baseline,1 month,2 and 3 months after the inserted of the splints using the craniomandibular index (cmi) for temporomandibular joint function and phq-9,gad-7 for psychological assessments,the tmj space and disc-condylar angle were measured through the cbct and mri scans,before and after ars therapy.

Eligibility criteria:
inclusion criteria: * anterior disc displacement with reduction (addwr) confirmed by magnetic resonance imaging (mri) * classified as asa 1 or 2 * willing to participate and sign a written informed consent form. exclusion criteria: * pregnant women * heart pace disorders and epilepsy

Keywords: temporomandibular joint anterior disc displacement the visualization of treatment objective (vto) anterior repositioning splint
his bundle pacing synchrony comparing his pacing to intrinsic conduction while using the medtronic ecg belt system

Conditions: HBP

Summary: the hbp synchrony using ecg belt study is a prospective, non-randomized single site physician-initiated research study. the study will collect ecg belt data from up to 30 subjects at one single center. the target population will include subjects with a currently implanted medtronic cardiac implantable device who have a his placed lead. the purpose of the study is to characterize the electrical dispersion using the ecg belt provided by medtronic in patients who have a his placed lead and understanding the amount of synchrony with intrinsic conduction compared to his pacing.


Eligibility criteria:
inclusion criteria: * patient has previously been implanted with a medtronic ipg/icd and a his placed rv lead * patient has intrinsic av conduction * normal ef, defined as ef \>50%, as shown on recent echo within last 12 months * patient is willing and able to comply with the protocol * patient is 18 years of age or older exclusion criteria: ●patient is ventricular pacer dependent
iop fluctuations in primary open angle glaucoma patients before and after deep sclerectomy with collagen implant

Conditions: Primary Open Angle Glaucoma

Summary: primary open angle glaucoma (poag) is associated with inadequate drainage of the aqueous humor via the trabecular meshwork towards the systemic circulation. this may lead to an increase in iop and may damage the optic nerve. the purpose of glaucoma management is to lower iop in order to prevent progression of the optic neuropathy and subsequent visual loss. firstline treatment usually includes iop-lowering drug therapy. however, if iop remains uncontrolled and/or the optic nerve damage progresses despite controlled iop, surgery may be indicated. deep sclerectomy with a collagen implant (dsci) is a non-penetrating surgical procedure for the treatment of open angle glaucoma that allows the enhancement of the aqueous outflow. this forms the rationale to conduct this prospective, open label study to assess the 24-hour iop fluctuation profile recorded with triggerfish® in patients with poag before and after dsci.


Eligibility criteria:
inclusion criteria: * diagnosis of poag * documented glaucomatous vf damage with mean defect (md) \> 3 db * progressing glaucomatous damage justifying a dsci * aged ≥18 years, of either sex * not more than 4 diopters spherical equivalent on the study eye * not more than 2 diopters cylinder equivalent on the study eye * have given written informed consent, prior to any investigational procedures exclusion criteria: * corneal or conjunctival abnormality precluding contact lens adaptation * severe dry eye syndrome * patients with allergy to corneal anesthetic * patients with contraindications for silicone contact lens wear * patients not able to understand the character and individual consequences of the investigation * participation in other clinical research within the last 4 weeks
nirs in neonatal cardiac surgery

Conditions: Hypoplastic Left Heart; Surgery

Summary: due to the small size of infants and the use of bypass machines, physicians have difficulty assessing whether the infant's brain and body is getting enough oxygen during heart surgery. this study compares continuous monitoring via the nirs (near infrared spectroscopy) to the traditional methods of determining oxygen saturation.

one of the limiting factors in treating infants undergoing cardiac surgery is the difficulty in assessing systemic perfusion with accuracy. at children's healthcare of atlanta, near-infrared spectroscopy (nirs) is available, but has never been studied. in patients undergoing first stage palliation (norwood) for hypoplastic left heart, routine management will be utilized in addition to the nirs monitor. the following will be documented pre- and post-bypass, then every 4 hours for 24 hours after admission to the cardiac intensive care unit:nirs readings, lactic acid levels,mixed venous saturations,hemoglobin, hematocrit, arterial blood gases, heart rate, blood pressure, central venous pressure, left atrium pressure,core temperature, toe temperature, pulse oximeter reading, urine output, ventilator settings, inotropic levels. all the data will be entered into a database and analyzed.

Eligibility criteria:
inclusion criteria: * hypoplastic left heart * requiring stage 1 palliation * informed consent obtained exclusion criteria: * does not have hypoplastic left heart * is not having stage 1 palliation * no informed consent

Keywords: pediatric cardiac surgery
an open-label study to evaluate the effect of treatment with romosozumab or teriparatide in postmenopausal women

Conditions: Postmenopausal Osteoporosis

Summary: the primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (bmd) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy.


Eligibility criteria:
inclusion criteria: * postmenopausal women, aged ≥ 55 to ≤ 90. * received oral bisphosphonate therapy for at least 3 years immediately prior to screening * bmd t-score ≤ -2.50 at the lumbar spine, total hip or femoral neck * history of nonvertebral fracture after age 50, or vertebral fracture. exclusion criteria: * use of other agents affecting bone metabolism including strontium ranelate, fluoride (for osteoporosis), odanacatib (mk-0822) or any other cathepsin k inhibitor, iv bisphosphonates, denosumab, teriparatide (tptd) or any parathyroid hormone (pth) analogs, systemic oral or transdermal estrogen, selective estrogen receptor modulators (serms), activated vitamin d3, vitamin k2, calcitonin, tibolone, cinacalcet, systemic glucocorticosteroids: * history of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of study results, such as sclerosteosis, paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, cushing's disease, hyperprolactinemia, and malabsorption syndrome. * vitamin d insufficiency, defined as 25 (oh) vitamin d levels \< 20 ng/ml, as determined by the central laboratory. * current hyper- or hypocalcemia * current, uncontrolled hyper- or hypothyroidism

Keywords: postmenopausal osteoporosis
fingolimod versus interferon beta 1b in cognitive symptoms

Conditions: Multiple Sclerosis

Summary: the purpose of this pilot study is to evaluate, by means of a specific cognitive test battery (brief repeatable battery and delis-kaplan executive function system scale), the slowing/reduction of cognitive dysfunction progression in rrms patients after 18 months of treatment with fingolimod in comparison with interferon beta 1b treatment, and to evaluate which test of the battery is the most sensitive in detecting differences between treatment groups.


Eligibility criteria:
inclusion criteria: * patients with relapsing-remitting forms of ms defined by 2005 revised mcdonald criteria. * patients with active disease, defined as at least one clinical relapse in the last year, or two clinical relapses in the last two years if there are signs of disease activity at one brain mri scan performed in the last six months. * patients with cognitive impairment at screening, defined as at least one test of the rao's brief repeatable battery with scores falling outside the 90th percentile of the normative data. exclusion criteria: * patients who had already been treated with multiweekly interferon (interferon beta 1b, or beta 1a multiweekly) and had an unsatisfactory response according to the judgment of the investigator. * patients with hyperactive forms of the ms disease according to the judgment of the investigator. * patients with an edss score higher than 5. * patients with a prior or current diagnosis of major depression according to dsm-iv. * patients with a history of chronic disease of the immune system other than ms such as known immunodeficiency syndrome. other protocol-defined inclusion/exclusion criteria may apply

Keywords: multiple sclerosis cognitive symptoms relapsing-remitting multiple sclerosis (rrms) fingolimod magnetic resonance imaging (mri)