Kornimate/medical-research-clean huggingface dataset:
transanal versus laparoscopic total mesorectal excision: a cohort

Conditions: Rectal Cancer

Summary: the purpose of this study was to compare the long-term oncology outcomes and specimen quality of tatme and latme in the treatment of middle and low rectal cancer by a large sample cohort. at the same time, the local recurrence following a primary rectal cancer resection was analyzed to respond to the concerns about the event of the national suspension for tatme due to the high local recurrence rate in norway.

laparoscopic surgery is considered to have better visualization for more accurate separation and further injury reduction than open surgery. however, the oncology outcomes are still controversial. especially in the challenging patients who have narrow and deep pelvic, the disadvantage that it is difficult to obtain high-quality resected specimens during laparoscopic tme (latme) surgery is considered to be magnified. it is considered transanal total mesorectal excision (tatme) is an alternative method to solve this "old problem". however, as a new technology that has been around for only 10 years, the applicability of tatme worldwide needs to be further proved in long-term oncology. this prospective cohort study aimed to compare tatme surgery to latme surgery for mid and low-rectal cancer on long-term oncology outcomes from a single, experienced chinese center that was an early adopter of tatme.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 80 years old 2. confirmed rectal adenocarcinoma cancer pathologically 3. tumor location ≦ 12 cm from the anal margin 4. willing and able to provide written informed consent for participation in this study exclusion criteria: 1. distant metastasis before surgery 2. more than one colorectal tumor at diagnosis 3. familial adenomatous polyposis 4. recurrent rectal cancer 5. undergo transanal minimally invasive surgery 6. undergo palliative treatment 7. undergo emergency surgery

Keywords: rectal cancer tatme local recurrence
oxaliplatin and 5-fu based preoperative chemoradiation

Conditions: Rectal Cancer

Summary: oxaliplatin and 5fu based preoperative chemoradiation in rectal cancer.

effect of treatment, safety profile and quality of life scorings.

Eligibility criteria:
rectal cancer

Keywords: oxaliplatin, radiation
gore® septal occluder device for patent foramen ovale (pfo) closure in stroke patients

Conditions: Stroke; Transient Ischemic Attack

Summary: the primary objective is to determine if patent foramen ovale (pfo) closure with the gore® helex® septal occluder or gore® cardioform septal occluder plus antiplatelet medical management is safe and effective and reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack (tia) when compared to antiplatelet medical management alone in patients with a pfo and history of cryptogenic stroke or imaging-confirmed tia. a co-primary objective is to demonstrate that medical management plus closure with the study device reduces the risk of new brain infarct compared to medical management alone.


Eligibility criteria:
inclusion criteria: * presence of cryptogenic ischemic stroke or tia of presumed embolic infarction verified by a neurologist within 180 days prior to randomization * presence of patent foramen ovale (pfo), as determined initially by positive bubble study utilizing transesophageal echocardiography (tee), demonstrating spontaneous right-to-left shunting or right-to-left shunting during valsalva maneuver. * absence of an identifiable source of thromboembolism in the systemic circulation * no evidence of a hypercoagulable state * note: additional inclusion criteria may apply exclusion criteria: * other co-morbidities including, but not limited to, mural thrombus, dilated cardiomyopathy, atrial fibrillation/flutter, cardiac prosthetics (valves), mitral valve stenosis, aortic dissection, significant atherosclerosis, vasculitis, pre-existing neurologic disorders, multiple sclerosis, arteriovenous malformations, prior intracranial hemorrhage, severe central nervous system (cns) disease, severe disability related to prior stroke, and autoimmune disorders that would increase the risk of mortality or morbidity above what is typical for the treatment * previous myocardial infarction * active infection that cannot be treated successfully prior to randomization * sensitivity or contraindication to all proposed medical treatments * pregnancy or intent on becoming pregnant through 24-months after randomization * indications outside the parameters accepted for placement of the gore® helex® septal occluder / gore® septal occluder, including extensive congenital cardiac anomalies and defect diameter estimated to be \> 18mm * atrial septal anatomy that is expected to necessitate placement of more than one gore® helex® septal occluder / gore® cardioform septal occluder * need for concomitant procedure(s) that may confound detection of adverse events related to device placement * note: additional exclusion criteria may apply

Keywords: cryptogenic stroke transient ischemic attack tia pfo patent foramen ovale helex septal occluder pfo occluder
can blood glucose levels during the perioperative period identify a population at risk for hyperglycemia?

Conditions: General Anesthesia; Hyperglycemia

Summary: surgery performed during general anesthesia induces a stress effect on the body. our plan is to identify population at risk of hyperglycemia during perioperative period.

this is a prospective study to define the relationship between time profile of glucose control before, during and after surgery with patient variables, surgical variables and anesthetic variables. serum glucose levels will be measured preoperatively and then at 30 minute intervals during surgery. pain score, pain medication and glucose levels will be measured in the post anesthesia recovery room. subjects will be contacted 2 weeks following the date of surgery to determine the incidence of postoperative complications.

Eligibility criteria:
inclusion criteria: * elective surgery * 18-80 years of age exclusion criteria: * known diabetics * pregnant patients * cardiac surgery patients * liver transplant patients

Keywords: non diabetic catabolic energy state
rivaroxaban once daily versus dose-adjusted vitamin k antagonist on the biomarkers in acute decompensated heart failure and atrial fibrillation (road hf-af)

Conditions: Acute Heart Failure

Summary: vitamin k antagonists (vkas) are used to reduce the risk of stroke (cerebral vascular dysfunction) in af patients. however, vkas interact with drugs/food and the drug level is influenced by worsening of renal function, liver congestion or hemodynamic alterations in acute decompensated heart failure (adhf). new oral anticoagulants (rivaroxaban, apixaban, dabigatran) are alternatives to vka, such as warfarin. in post hoc analysis of rocket af trial, 63.7% patients had hf and treatment-related outcomes were similar in patients with and without hf (circulation hf. 2013; 6:740-7). so rivaroxaban 20 mg daily (or 15 mg daily in patients with creatinine clearance 30-49 ml/min) was safe in nonvalvular af patients with hf. however, the clinical effect and safety of rivaroxaban were largely unknown in acute decompensated heart failure (adhf) patients with atrial fibrillation (af). road hf-af is the exploratory study to assess the change of surrogate markers (hstn, d-dimer) when treated with rivaroxaban vs. warfarin and to strengthen the basis for future biomarker-based therapy in adhf patients


Eligibility criteria:
inclusion criteria:hospitalized patients with a primary diagnosis of adhf with af one of the following criteria and lvef ≤ 40% (at least 1 year before admission or admission) 1. dyspnea at rest 2. tachypnea; a respiratory rate \> 20/min 3. rales 4. pulmonary edema on chest x-ray exclusion criteria: 1. history of increased bleeding risk (like rocket af exclusion criteria) 2. contraindication to anti-coagulation therapy 3. acs diagnosis 4. hospitalization plan for pci, coronary artery bypass graft surgery, other cardiac invasive interventions (e.g. catheter ablation, pacemaker, crt, icd implantation) 5. currently on dual anti-platelet therapy (aspirin + adp receptor antagonist) or single antiplatelet therapy with a novel ap (e.g. ticagrelor, prasugrel) 6. cardiogenic shock (systolic blood pressure, sbp, \< 80 mmhg) 7. patients with crcl \< 30 ml/min using creatinine-based ckd-epi equations 8. elevated liver enzymes (3 times over upper reference limit) or liver cirrhosis 9. uncontrolled hypertension (sbp \> 180 mmhg) 10. allergy, adverse drug reaction, hypersensitivity to rivaroxaban or warfarin 11. life expectancy \< 6 months (e.g. metastatic malignancy) 12. pregnancy, or women of childbearing age
rls in adults: comparing immediate release formulation with extended release formulation of ropinirole

Conditions: Restless Legs Syndrome; Restless Legs Syndrome (RLS)

Summary: restless legs syndrome (rls) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks


Eligibility criteria:
inclusion criteria: * diagnosis of primary rls according to rls diagnostic clinical interview and international restless legs syndrome study group diagnostic criteria. * disturbed sleep, with both evening (between 5:00 pm and 8:00 pm) and night time (between 8:00 pm and 8:00 am) symptoms requiring treatment. exclusion criteria: * signs of secondary rls. * primary sleep disorder or movement disorder other than rls. * unstable medical conditions. * inability to tolerate dopamine agonists or dopamine antagonists. * unwilling to discontinue any medications currently being taken to treat rls symptoms.

Keywords: restless legs syndrome
assessment of pcso-524 relative to a comparator product

Conditions: Healthy

Summary: a marine lipid oil extract isolated from the new zealand greenshell® mussel, perna canaliculus (p. canaliculus), contains a unique synergistic blend of marine fatty acids. the objective of the this study is to evaluate the acute (5-hour) and chronic (21-day) bioavailability of a fixed dose of pcso-524 compared to a fish oil product in a population of healthy adult participants.


Eligibility criteria:
inclusion criteria: * the individual is fluent in english and understands the study requirements * the participant is willing and able to comply with all requirements defined within this protocol. * the individual is willing to provide written informed consent * the individual is male or female * the individual is between 18 and 65 years of age * the individual's blood epa+dpa+dha ≤ 5.2% at screening exclusion criteria: * the individual is unable to or refuses to provide written informed consent * the individual has taken omega-3 supplements within 3 months of screening. * supplements containing any of the following sources of omega-3s will exclude the individual from the study: fish oil, flax oil, krill oil, green-lipped mussel, chia, perilla, algea * the individual's blood epa+dpa+dha ≥ 5.2% at screening * the individual is female and pregnant or breastfeeding, or plans to be during the trial period * the individual has known allergies product ingredients (fish/seafood) * the individual has any significant medical illness or condition * the individual has reported a history of drug dependence or substance abuse (excluding nicotine) * the individual is taking lipid-altering medications (statins, niacin, carnitine, fibrates etc.) * the individual is unable to abstain from caffeine, alcohol or physical activity for 24 hours before each treatment visit * the individual will be excluded if he or she has any additional conditions that, in the investigator's opinion, would preclude the participant from completing the study or would not be in the best interest of the subject. this would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol

Keywords: fish oil epa dha omega-score omega-3 fatty acids green-lipped mussel omega-score < 5.2%
treatment satisfaction with ra-223 in japan

Conditions: Prostatic Neoplasms

Summary: this study aims to answer the research question: are japanese bone metastatic crpc patients satisfied with their ra-223 treatment, and what factors drive such satisfaction? it also aims to determine patient anxiety regarding prostate cancer while on treatment with ra-223, and assess the effect on quality of life.

this is a local, japanese, prospective, longitudinal, observational, company-sponsored, multi-center, single arm study that will describe treatment satisfaction with ra-223 in 150 bone metastatic crpc patients on 1st to 3rd line crpc therapy. all outcomes will be obtained using pro questionnaires at 4 time points: before treatment, during treatment, and at 1-month after the last treatment cycle.

Eligibility criteria:
inclusion criteria: * age ≥20 years old (age of maturity in japan) * male, diagnosed with crpc * with ≥2 bone metastases and no visceral metastasis based on the most recent imaging procedure * eastern cooperative oncology group performance status (ecog-ps) 0-1, not in end-stage palliative care * designated by examining physician to undergo ra-223 treatment either in the 1st, 2nd, or 3rd line of crpc therapy * has provided written, informed consent (in japanese) * has ≥6 months life expectancy exclusion criteria: * participation in an investigational program with interventions outside of routine clinical practice * currently receiving any chemotherapy for crpc or any new hormone therapy (enzalutamide, abiraterone acetate) at enrolment * where any of the below conditions apply: * started or switched to new androgen deprivation therapy (adt) (e.g., lhrh agonists and antagonists, anti-androgens, estrogens,) within 4 weeks prior to enrolment or planning to start new treatment prior to 1st ra-223 injection * treatment with anticancer-chemotherapy within previous 4 weeks, or planned before the 1st ra-223 injection, or failure to recover from adverse events (aes) (ctcae grade \>2) due to anticancer chemotherapy administered more than 4 weeks prior * systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the previous 24 weeks * previous hemi-body external radiotherapy * imminent or established spinal cord compression based on clinical findings and/or magnetic resonance imaging (mri) * presence of other maligancy at enrolment * otherwise deemed incapable of participating by examining physician

Keywords: castration resistant prostate cancer patient reported outcome
maternal sleep disordered breathing and fetal growth

Conditions: Sleep Disordered Breathing

Summary: sleep disordered breathing (sdb) is a common condition affecting up to 9% of adults with serious neurocognitive, metabolic and cardiovascular consequences that has a significant impact on public health. evidence indicates that the physiologic changes occurring during pregnancy, particularly during the third trimester, increase the risk of those women to develop sdb. as in the general population, sdb during pregnancy is more frequent among obese women. in the light of the increasing prevalence of obesity among females of reproductive age, sdb may thus have an increasingly significant impact on women's and children's health by contributing to the adverse maternal and fetal outcomes associated with maternal obesity. only a limited amount of data is available on the consequences of maternal sdb during pregnancy. even less information is available on the effect of maternal sdb on fetal growth and development. the current proposal is designed to specifically explore the effect of maternal sdb on fetal growth. it has been suggested that fetal growth as reflected in birth weight is a strong correlate for conditions occurring in the intrauterine environment with potential long lasting influence on a child's health. our overall hypothesis is that the intermittent hypoxia, sleep fragmentation and the metabolic alterations associated with maternal sdb will affect fetal growth. using a variety of methods and a multidisciplinary approach, we will explore the following objectives: 1) the effect of maternal sdb on fetal growth ; 2) to explore mechanisms that may underlay the effect of maternal sdb on fetal growth 3) to explore the long term (first 3 years of life) effect of maternal sdb on a child's growth. the results of this study will make an important contribution to the fields of women and children's health. it will provide better insight into the mechanisms by which disrupted maternal sleep affects fetal growth. we expect that the findings from our study will enable the defining of a new treatable clinical entity or syndrome: "the infant of the gestational sdb mother", for which early diagnosis and intervention might be of major importance to the newborn infant.


Eligibility criteria:
inclusion criteria: * low risk third trimester pregnant women exclusion criteria: * pregnancy complications (preeclampsia, htn, gdm), * any chronic medical condition.

Keywords: pregnancy, snoring, fetal growth
microanalysis of changes in 3d geometry of orthodontic mini-implants

Conditions: Malocclusions; Malocclusion, Angle Class I; Malocclusion, Angle Class II

Summary: the orthodontic mini-implants used in the study are temporary screws inserted into the bone to provide anchorage for challenging tooth movements that could not be carried out using the patient's own teeth. they are made of a medical grade titanium alloy (ti6al4va), with a length of 8 mm and a diameter of 1.3 mm. after the completion of the treatment phase requiring specific anchorage, they are removed and disposed of as a medical waste. the insertion of the mini-screw is conditioned by the individual treatment plan and the treatment protocol would not differ from the standard treatment. the aim of the project is to analyze changes in the macrogeometry and wear of the surfaces of retrieved orthodontic micro-implants after their clinical use. upon completion of clinical tasks, the mini-screws will be removed and retrieved for laboratory phase of the study. the laboratory phase will consist of: microscopic and profilometric examinations, as well as scanning before insertion and after removal of the mini-implants, and a clinical phase: the use of previously scanned and sterilized mini-implants in patients participating in the study.


Eligibility criteria:
inclusion criteria: * adult patient in the active phase of orthodontic treatment with a fixed orthodontic appliance. * the individual treatment plan involving tooth movements that require anchorage reinforcement: asymmetric intrusion, space closure through mesialization or distalization. * clinical indications and the possibility of placing a mini-implant in the interradicular space of the maxillary/mandibular alveolar bone (possibility of using the absoanchor sh1312-08 mini-implant). * informed consent of the patient. exclusion criteria: * individualized treatment plan involving the use of a mini-implant different from the one used in the study. * lack of consent for participation in the study.

Keywords: orthodontic mini-implants skeletal anchorage orthodontic miniscrews orthodontic mini-screws temporary anchorage device tad 3d superimpostion geometric changes
cloud based follow up of cpap treatment

Conditions: Sleep Apnea Syndromes

Summary: obstructive sleep apnea (osa) is treated with a continuous positive airway pressure, so called cpap. a new technology that enables telemetric monitoring of cpap therapy. this study randomizes 560 patients to a) conventional follow up procedures or b to a telemedicine based follow up procedure. main endpoint parameter is cpap treatment compliance at 3 months after start of treatment.

background: obstructive sleep apnea (osa) is treated with a continuous positive airway pressure, so called cpap, during sleep. cpap startup and follow-up is performed at four sleep clinics in the west swedish region (su / s, säs, skas, näl). patient volumes are high, waiting times are long and long-term follow-up is inconsistent. a new technology that enables telemetric monitoring of cpap therapy based on transfer of therapy data to a data cloud has been introduced. healthcare personnel can identify patients with therapy problems. data from minor studies suggest several benefits of this telemedicine solution (increased therapeutic capacity, lower patient and community costs and a time benefit for the sleep medicine unit). today, the sleep clinical in the region use different procedures for monitoring cpap treatment. scientific question: is telemedicine monitoring of cpap treatment an adequate solution for follow up in all patients ? is the additional cost of a telemedicine solution balanced by a better outcome after therapy? hypothesis: intensive telemedicine monitoring, especially at the start of cpap therapy, leads to improved cpap care at the participating sleep units. method: the study randomizes 560 patients (moderate to severe sleep apnea) to different cpap treatment follow up procedures: a) the current routine of the sleep clinic or b) the new telemedicine solution (1: 1 randomization). the main outcome parameter of the study is the mean cpap use after 3 months of treatment. secondary outcome parameters include the reduction of sleep apnea intensity, daytime sleepiness, and patient-related outcome measures (prom). aim: the aim of the study is to map the pros and cons of a telemedicine solution in cpap therapy regarding treatment outcomes, patient quality of life and resource utilization at the sleep center.

Eligibility criteria:
inclusion criteria: * verified sleep apnea diagnosis according to icsd ii criteria * indication for cpap treatment according to swedish national guidelines * capacity to read and understand the swedish language * willingness to test cpap treatment exclusion criteria: * instable concomitant disease requiring frequent hospitalization * alcohol and drug abuse * non-availability during the follow up during 3 months (e.g. frequent or long-term travelling) * hypoventilation syndrome with pco2\>7kpa

Keywords: compliance telemedicine patient related outcome measures
small bowel motor impairment in scleroderma: results of a prospective 5-year manometric follow-up

Conditions: Systemic Sclerosis

Summary: small bowel involvement is still recognized to be associated with great morbidity and mortality in ssc patients, leading particularly to malabsorption and intestinal pseudo-obstruction. intestinal disorders directly related to ssc have, in fact, been reported to be one of the most common causes of death. in a previous prospective study, we have demonstrated the high prevalence of small intestinal involvement in ssc patients, using upper intestinal manometry; in turn, 88% of our ssc patients had upper intestinal motor disturbances. however, to date, no authors have yet analyzed the course of upper intestinal motor dysfunction in ssc. the aims of this study were therefore to assess the 5-year course of small bowel motor disorders, using manometry in patients with systemic sclerosis (ssc), and to investigate for an association between upper intestinal motor dysfunction outcome and other clinical manifestations of ssc.


Eligibility criteria:
inclusion criteria: * patients with systemic sclerosis, who had an upper intestinal tract manometry 5 years before, with: * age over 18 years * written informed consent exclusion criteria: * pregant women * patients with psychiatric conditions * unwritten informed consent