Kornimate/medical-research-clean huggingface dataset:
sphincter-preserving surgery after preoperative treatment of ultra-low rectal carcinoma

Conditions: Rectal Cancer

Summary: this phase iii trial included patients with low rectal adenocarcinoma which initially required apr, with a mean clinical distance between the tumor inferior pole and the levator ani of 0.5 cm. patients were randomly assigned to receive high-dose radiation (45 + 18 gy) or radiochemotherapy (45 gy + 5fu continuous infusion). the surgical decision was based on the tumor status at surgery. all surgeons used a homogenous ssr technique such as intersphincteric resection. the primary endpoint was the ssr rate.


Eligibility criteria:
inclusion criteria: * adenocarcinoma of ultra-low rectum at high risk of abdomino-périneal amputation * tumor classified as eer ut2-ut3, whatever the nodal status * pathological confirmation of rectal adenocarcinoma without evidence of distant metastasis (m0), t2 or t3 resectable tumors without striated sphincter involvement and with the inferior margin of the tumor located less than 2 cm from the upper part of the levator ani. * age 18 years or older * informed and written consent exclusion criteria: * t1 * t4 (proven invasion of sphincter) * diffuse metastatic syndrome (no curative intent, short expected life span) * preoperative incontinence (non due to the tumor)

Keywords: sphincter preservation neoadjuvant therapy
safety and efficacy of crd007 in adult asthma subjects

Conditions: Asthma

Summary: this is a double-blind, randomised, placebo-controlled, parallel group, phase 2 trial evaluating crd007 administered orally b.i.d for 14 weeks for the treatment of asthma. crd007 will be given as add on to a background of commonly used controller medication, i.e. inhaled corticosteroid (ics) with or without long-acting beta2-agonist (laba). by gradually reducing the background controller medication, the efficacy and safety of crd007 will be evaluated on top of several dose levels of this medication.

the present trial will include subjects with diagnosed asthma. the trial involves a total of 11 visits (visit 1-2 are screening visits, visit 3 randomisation visit, visits 4-10 treatment visits and visit 11 follow-up visit). the subjects will be monitored by medically qualified staff every second week at clinic visits, where the reduction of their background controller medication will be reduced, if their asthma is controlled. between visits to the clinic the subjects have to complete a diary.

Eligibility criteria:
inclusion criteria: * written informed consent * age ≥18 years old * diagnosis of asthma according to global initiative for asthma (gina) guidelines * atopic phenotype as assessed by the investigator * treated with ics and laba for at least 12 weeks prior to visit 1with protocol defined daily doses * blood eosinophils ≥0.15\*109/l at visit 1 * demonstration of forced expiratory volume at one second (fev1) \>60% of the predicted value at visit 1 * demonstration of acq6 ≥ 0.5 and ≤1.5 at visit 1 * reversibility of at least 12% and 200 ml in fev1 exclusion criteria: * lower respiratory tract infection \<6 weeks prior to visit 1 * current smokers * significant concurrent, uncontrolled medical condition as defined by the protocol * others, as defined in the protocol
high septal pacing for cardiac resynchronization therapy

Conditions: Heart Failure; Left Bundle Branch Block; Heart Disease

Summary: the purpose of this acute study is to perform a preliminary investigation of high septal right ventricular pacing in the vicinity of the his bundle region as an alternate or adjunctive means for cardiac resynchronization in patients with heart failure and wide qrs.

the history study is an acute, cross-sectional, multi-center, feasibility study with a randomized within patient test sequence designed to characterize the effects of high septal right ventricular pacing in the vicinity of the his bundle region compared to conventional biventricular pacing for cardiac resynchronization therapy.

Eligibility criteria:
inclusion criteria: * 50 years of age or older * patients willing and capable of providing informed consent, participating in all testing associated with this clinical investigation * patients undergoing a crt implant procedure (pacemaker or defibrillator) for one of the following reasons * indicated for a new device * device upgrade * device replacement * lead revision * note: recognized indications for crt-p and crt-d as of october 2009 are valid for inclusion in this study. should new indications become approved during the study conduct; those will also be applied within the inclusion criteria. exclusion criteria: * patients unwilling or incapable of signing the informed consent, or patients having previously withdrawn their consent * patients in af that cannot be cardioverted for the study * rbbb pattern * sustained, uncontrolled ventricular tachycardia * sinus rhythm \ 100 bpm * complete av node block * second degree av block * women who are pregnant or plan to become pregnant during the study (method of assessment upon physician's discretion); * history of (hemorrhagic) cerebro-vascular accident or tia

Keywords: cardiac resynchronization therapy pacing his bundle
d-cycloserine in the management of chemotherapy-induced peripheral neuropathic pain

Conditions: Neurotoxicity; Pain; Breast Cancer

Summary: d-cycloserine may help lessen pain and other symptoms of peripheral neuropathy caused by chemotherapy. it is not yet known whether d-cycloserine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy. this randomized, double-blind, placebo-controlled clinical trial was designed to study d-cycloserine at 2 different doses to see how well each works compared to the other and to a placebo in treating cancer patients with peripheral neuropathy caused by chemotherapy.

this is a randomized, double-blind, placebo-controlled study. initially, patients were randomized to 1 of 2 treatment arms (d-cycloserine 250 mg twice daily or placebo twice daily), and treated for up to 4 weeks in the absence of unacceptable toxicity. later, the design was changed to randomize patients to 1 of 3 arms as follows: * d-cycloserine 50 mg twice daily for up to 12 weeks * d-cycloserine 200 mg twice daily for up to 12 weeks * placebo twice daily for up to 12 weeks

Eligibility criteria:
inclusion criteria: * patients will be at least 18 years of age. * patients will be experiencing moderate to severe peripheral neuropathic pain * patients may be on chronic adjuvant pain medications such as antidepressants but must be on stable doses for at least one week prior to admission. * patients may be taking concurrent opioids but they must be willing to allow us to monitor their opioid use while on the trial. * patients must have chronic peripheral neuropathic pain will be defined as pain of 3 or more months duration which began in association with chemotherapy. * patient's will have bilateral peripheral neuropathic pain symptoms primarily involving the feet * patients must have breast cancer (any stage) * patients must be able to read and speak english and provide informed consent. * patients may be receiving chemotherapy as long as the agents are not known to cause a peripheral neuropathy. * patients must have an ecog performance status \< 3 and be able to attend the physician study visits * patients must not concurrently use gabapentin or pregabalin or must be willing to wean off their anti-convulsant medications prior to starting the trial. * patients may have diabetes mellitus (type 1 or 2) as long as there is no preexisting neuropathy. exclusion criteria: * patients will not have secondary cause of neuropathic pain including: hiv/aids,traumatic injury, or a personal history of non chemotherapy-induced neuropathy. * patients will not have a history of major depression or severe anxiety. * women of childbearing age will agree to take measures to prevent pregnancy and will not breast-feed while on the study medication. women who are currently pregnant will not be invited to participate in this study. * patients will not have a history of seizures. * patients cannot be currently receiving antibiotic therapy for tuberculosis (e.g. isoniazid).

Keywords: pain neurotoxicity breast cancer
two different regimens of misoprostol in retained placenta

Conditions: Postpartum Haemorrhage; Retained Placenta

Summary: this study evaluates intra umbilical vein injection of 800 µg versus 400 µg misoprostol for the treatment of retained placenta to reduce the need of manual removal of placenta under general anaesthesia

the third stage of labor may be complicated by retained placenta, which may cause severe bleeding and infection, with a potentially fatal outcome. manual removal of placenta is the current standard of management of retained placenta which usually requires general or regional anaesthesia at a hospital and it is an invasive procedure that may lead to bleeding, trauma and infection. intraumbilical injection of uterotonic agent( misoprostol) is an easy, non invasive procedure. a randomized clinical trial are required to determine the difference between two doses of misoprostol 400 versus 800 micro gram for management of retained placenta

Eligibility criteria:
inclusion criteria: * women with a singleton pregnancy, delivered vaginally * 28 weeks of gestation and more, * had a prolonged third stage of labor (more than 30 minutes) despite active management, * haemodynamically stable and accept to participate in the trial exclusion criteria: * multiple pregnancies, * previous caesarean delivery, * haemodynamically instability, severe anaemia (haemoglobin concentration \<8 g/dl), * chorioamnionitis * refused to participate in the trial

Keywords: retained placenta misoprostol double blind randomization haemorrhage
use of the nasal cannula during covid-19

Conditions: COVID 19

Summary: the objective of this investigation is to determine the incidence of the use of the low flow nasal cannula in suspected or confirmed cases with covid-19

an anonymous questionnaire will be sent to a group of anesthesiologists via email which will allow to collect information about the use, or not, of the low flow nasal cannula, the type of procedure where it is used, and the type of personal protection weared.

Eligibility criteria:
inclusion criteria: * only for physicians exclusion criteria: * not physicians

Keywords: low flow nasal cannula anesthesia sedation regional anesthesia
study to evaluate safety and immunogenicity of butantan seasonal influenza vaccine - flu-02-ib

Conditions: Influenza

Summary: prospective cohort study to evaluate the safety and immunogenicity of the butantan influenza vaccine (fragmented and inactivated) among healthy adults with 18 to 59 years of age and elderly older than 60 years of age.

prospective cohort study to assess safety of one dose of thebutantan influenza vaccine (fragmented and inactivated) in the first 3 days after vaccination and its immunogenicity 21 days after vaccination among healthy adults with 18 to 59 years of age and elderly older than 60 years of age..

Eligibility criteria:
inclusion criteria: * healthy adults, male or female aged 18 to 59 * elderly aged 60 years completed and above * to be available to participate in the study throughout its duration (approximately 21 days) * to have medical indication to be vaccinated against influenza * to demonstrate intention to participate in the study, as documented by signature in the study´s informed consent form. exclusion criteria: * evidence of active neurological, cardiac, pulmonary, hepatic or renal disease as clinical history and/or physical examination (except hypertension under control among the elderly) * compromised immune system diseases including: hiv, diabetes mellitus, cancer (except basal cell carcinoma) and autoimmune diseases * behavioral, cognitive or psychiatric disease that in the opinion of the principal investigator or his representative physician, affects the participant ability to understand and cooperate with all study protocol requirements * abusive usage of alcohol or drugs in the past 12 months that has caused medical, professional or family problems, indicated by clinical history * known systemic hypersensitivity to eggs or to any component of the vaccine * history of severe adverse reaction after previous administration of an influenza vaccine within 6 weeks following vaccination

Keywords: influenza
groin injuries in finnish contact sports

Conditions: Groin Injury

Summary: the prevalence of acute and chronic groin injuries in athletes is between 5 and 10 %. this observational case-control study follows three contact sport teams (soccer, ice-hockey and bandy) for two years to find out the prevalence and reasons for groin pain. clinical examination, pain scores and pelvic magnetic resonance imaging (mri) are performed. hip and groin questionnaire (hagos) is used to determine severity of groin injuries.

the prevalence of chronic groin pain in athletes and physically active adults is between 5 and 10 %. common causes include adductor tendonitis, musculus rectus abdominis tendopathy, osteitis pubis (edema on mri scans at pubic symphysis) or disruption of the posterior wall of inguinal canal or iliopsoas muscle. this observational case-control study follows three contact sports team (male soccer, ice-hockey and bandy) for two years to find out prevalence of acute and chronic groin pain. adult (\>18 years old) male athletes with acute or chronic groin pain during the study pediod are included. outcome measures are clinical examination, pain scores, exact diagnosis and repeated pelvic mri (two times) are performed in each patients and three control atheletes in each team. hip and groin questionnaire (hagos) is used to determine the severity of groin injuries. the end-points of study are prevalence of groin injuries and exact diagnosis.

Eligibility criteria:
inclusion criteria: * acute (1-30 days) groin injury * subacute or chronic groin injury (lasting \>30 days) * pain in the groin or hip area exclusion criteria: * inguinal hernia * postoperative pain * metallic plates or screws in the pelvis (mri impossible)

Keywords: groin pain, groin injury, magnetic resonance imaging
ferinject® assessment in patients with iron deficiency and chronic heart failure (fair-hf)

Conditions: Chronic Heart Failure; Iron Deficiency; Iron Deficiency Anemia; Anaemia

Summary: this study is designed to evaluate the efficacy of ferinject® in improving symptoms of chf in patients with iron deficiency. analyses will focus both on subjective and objective measures. furthermore, the tolerability and safety of ferinject® treatment will be evaluated.


Eligibility criteria:
inclusion criteria: * in new york heart association (nyha) ii-iii functional class due to stable symptomatic chronic heart failure (chf) * left ventricular ejection fraction (lvef) 40% or lower for patients in nyha ii and 45% or lower in nyha iii * screening haemoglobin (hb) at least 9.5 g/dl but below or equal to 13.5 g/dl (average of 2 haemoglobin concentrations) * screening ferritin below 100 µg/l, or below 300 µg/l when transferrin saturation (tsat) is below 20% exclusion criteria: * history of acquired iron overload. * known active infection, clinically significant bleeding, active malignancy. * chronic liver disease and/or screening alanine transaminase (alt) or aspartate transaminase (ast) * anaemia due to reasons other than iron deficiency * immunosuppressive therapy or renal dialysis (current or planned within the next 6 months). * history of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months. * unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias. * acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months. * coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months.

Keywords: chronic heart failure iron deficiency iron deficiency anaemia anaemia heart disease
effectiveness of a home-based ergonomic intervention program in caregivers of chronic post-stroke patients

Conditions: Stroke; Quality of Life

Summary: the objective of the present study is to evaluate the effectiveness of two home-based ergonomic intervention programs compared to a control group on the quality of life of caregivers of post-stroke patients

stroke is a neurological pathology that can cause functional problems and an impairment to perform activities of daily living at home. for this reason, these patients need the support of a caregiver. caregivers of post-stroke patients often have also problems with their quality of life because of the care that they must provide. these problems appear mainly during the support tasks in the activities performed at the patient's home. the objective of the present study is to evaluate the effectiveness of two home-based ergonomic intervention programs compared to a control group on the quality of life of caregivers of post-stroke patients

Eligibility criteria:
inclusion criteria: * being caregivers of post-stroke patients * being over 18 years old exclusion criteria: * being caregiver of patients with other neurological patients
an observational study to investigate the use of aflibercept 8 mg to treat adult patients with neovascular age-related macular degeneration (namd) and diabetic macular edema (dme) in a real-world setting

Conditions: Neovascular Age-related Macular Degeneration (nAMD); Wet Age-related Macular Degeneration (AMD); Diabetic Macular Edema (DME); Visual Impairment

Summary: the purpose of this research study is to observe the patient's clinical care and how eylea® hd is used as a treatment in real-world settings. patients are asked to join the study because they have either neovascular age-related macular degeneration (namd/wet age-related macular degeneration \[amd\]) or diabetic macular edema (dme). patients cannot have used eylea® hd in the past and the doctor must be planning to treat namd or dme with a new prescription of eylea® hd (aflibercept 8 mg).


Eligibility criteria:
key inclusion criteria for patients with namd: 1. any patient aged at least 50 years at the time of enrollment 2. diagnosis of namd (per physician) 3. previously treated patient cohort, patients that had treatment with any ocular intervention for namd in the study eye at any time before starting aflibercept 8 mg, as defined in the protocol 4. for treatment-naïve patient cohort, patients never receiving previous treatment in the study eye for namd, as defined in the protocol 5. initiating treatment with aflibercept 8 mg for namd key inclusion criteria for patients with dme: 1. any patient aged at least 18 years at the time of enrollment 2. macular edema associated with dme (per physician) 3. diagnosis of diabetes mellitus type 1 or type 2 4. for previously treated patient cohort, treatment with another intravitreal (ivt) anti-vegf agent(s) or ivt steroids, or surgery/laser for dme in the study eye at any time before starting aflibercept 8 mg, as described in the protocol 5. for treatment-naïve patient cohort, patients never previously treated with ivt agents or surgery/laser in the study eye for dme 6. initiating treatment with aflibercept 8 mg for dme key exclusion criteria for patients with namd 1. macular edema/hemorrhage/choroidal neovascularization due to any other cause besides namd 2. any systemic or ocular condition that would prevent any improvement of va in the study eye (eg, permanent visual impairment or blindness from any cause) 3. any patients that have been treated with photodynamic therapy 4. treatment with aflibercept 8 mg prior to baseline key exclusion criteria for patients with dme: 1. macular edema due to any other cause besides dme 2. any systemic or ocular condition that would prevent any improvement of visual acuity in the study eye (eg, permanent visual impairment or blindness from any cause) 3. treatment with aflibercept 8 mg prior to baseline note: other protocol-defined inclusion / exclusion criteria apply

Keywords: treatment-naïve previously treated degenerative disease vascular endothelial growth factor (vegf) diabetic retinopathy (dr)
effects of exercise and metformin on methylglyoxal levels in prediabetic individuals

Conditions: Methylglyoxal; PreDiabetes; Exercise; Metformin

Summary: the aim of this study is to compare the effects of exercise, standard lifestyle changes and metformin on mgo in prediabetic individuals.

there is no comparative study in the literature evaluating the effects of exercise and metformin on mgo in prediabetic patients. the aim of this study is to compare the effects of exercise, standard lifestyle changes and metformin on mgo in prediabetic individuals.

Eligibility criteria:
inclusion criteria: * patients who were newly diagnosed with prediabetes by oral glucose tolerance test (ogtt) and/or hba1c, * who were assessed as physically inactive (level 1) according to the international physical activity questionnaire * who had sufficient motivation to participate in the exercise program (assessed by one-on-one interviews conducted by the researchers), * who were deemed suitable to participate in the exercise program after a cardiac examination by a cardiologist (with resting electrocardiogram and questioning of cardiac symptoms, and advanced tests such as exercise electrocardiogram test when necessary), * who had the same weight (±2.5 kg) for 6 months before participating in the study. exclusion criteria: * having a serious medical condition that would prevent the person from participating in the exercise study (e.g. advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.), * having used metformin for 6 months before the study, having cardiovascular disease, * heart failure, cancer, having a bmi \&lt;19 kg/m2, receiving hormone replacement therapy, * having a life expectancy of less than 1 year, being hiv positive, substance use, * functional dependence, having an orthopedic disease that prevents physical activity, * having cognitive impairment and other diseases that would affect the study results (respiratory diseases, muscle diseases, non-alcoholic fatty liver disease, etc.), * using medications or supplements that would affect the study results.

Keywords: physical activity prediabetes metformin methylglyoxal