Kornimate/medical-research-clean huggingface dataset:
parenteral nutrition therapy in patients with incurable cancer

Conditions: Neoplasms; Terminal Illness

Summary: parenteral nutrition (pn) treatment in patients with incurable cancer is understudied and the level of evidence for clinical meaningful effects is weak. guidelines give few specific recommendations regarding which patients with incurable cancer that should be offered pn treatment. according to the norwegian prescription database, the use of parenteral nutrition has more than doubled in the period 2004-2015. these numbers do not separate between diagnoses and medical conditions, so the current use of medical nutrition in cancer patients in norway is not known. the decision to initiate parenteral nutrition is taken at hospitals, whereupon the patient returns home to their respective municipalities and receives follow-up by the home care service. there are often uncertainties about the duration of treatment, as patients' clinical condition can change rapidly. one major challenge health care professionals face is to decide when to end medical nutrition therapy. patients and relatives may experience fear that discontinuation of medical nutrition accelerates death, while health care professionals often experience that nutrition in many cases does not help and inflicts negatively on patients' condition. this makes communication concerning end of nutritional treatment between health care professionals at several health care levels, patients and their relatives challenging. there is a need for a stronger evidence base considering the effect of medical nutrition in patients with incurable cancer. to be able to study the effect of pn treatment, more studies on clinical practice of pn treatment to patients with incurable cancer is needed. aspects like indication for use, dosage and duration of pn treatment is poorly described in the available literature. thus, the aim of this study is to describe indications for use of pn, duration of treatment, reasons for discontinuation, method of administration, possible benefits and complications as well as survival.


Eligibility criteria:
inclusion criteria: * patient with incurable cancer * use of parental nutrition in palliative setting exclusion criteria: * still alive

Keywords: parenteral nutrition medical records palliative care disease progression
selection of shock energy in out-of-hospital cardiac arrest

Conditions: Sudden Cardiac Death; Arrhythmia; Survival

Summary: sudden cardiac death is the most frequent cause of death in industrialized countries. the most efficient interventiont in ventricular fibrillation is defibrillation in an appropriate timely manner. but since the intervention of defibrillation the optimal shock energy is unknown. as a too low energy is not able to terminate ventricular fibrillation a too high energy may cause asystole wich jeopardizes survival itself. we study the efficacy of different shock energies on the termination of ventricular fibrillatiion and survival.


Eligibility criteria:
inclusion criteria: * out of hospital sudden cardiac death * ventricular fibrillation exclusion criteria: * non cardiac death * asystole
pharmacokinetics and tolerability of zavesca® (miglustat) in patients with juvenile gm2 gangliosidosis

Conditions: Gangliosidoses GM2

Summary: the purpose of the study is to investigate the pharmacokinetics of zavesca (miglustat, ogt918) when given as single and multiple doses in juvenile patients with gm2 gangliosidosis.

the gm2 gangliosidoses are a group of neuro-degenerative lysosomal storage diseases resulting from accumulation of gm2 and related glycolipids in the central nervous system (cns). tay-sachs and sandhoff disease are two variants which are indistinguishable in clinical grounds. according to the onset and rate of disease progression, the condition can be categorized in infantile, juvenile and adult forms. this open-label, single-arm study is designed to assess the pharmacokinetics, safety and tolerability of miglustat in juvenile patients. miglustat will be administered at a maximum dose of 600 mg/day, divided into three doses per day. the dose used for patients in this pediatric age range will be related to the patient's body surface area. the pharmacokinetics assessments for the study will be performed in-hospital during a 24 hour period, and will take place at the day one and at the month 3 visits. the clinical (which includes safety and tolerability) assessments will be performed throughout the 24-month study period.

Eligibility criteria:
inclusion criteria: * diagnosis of gm2 gangliosidosis confirmed by demonstration of profound deficiency of β-hexosaminidase a or a \& b in peripheral blood leukocytes or cultured skin fibroblasts * aged 6 to 20 years * onset of characteristic clinical symptoms of the disease before age 15 years * normal renal or hepatic function exclusion criteria: * fertile patients who do not agree to use adequate contraception throughout the study and for 3 months after cessation of miglustat treatment. * patients who cannot tolerate the study procedures, cannot be compliant to therapy or who are unable to travel to the study center as required by this protocol. * patients receiving other investigational agents within 3 months of study initiation. * patients with disease that may affect absorption or elimination of drugs. * patients suffering from clinically significant diarrhea (\>3 liquid stools per day for \> 7 days) without definable cause within 3 months of baseline visit, or who have a history of significant gastrointestinal disorders. * patients with swallowing difficulties. * patients with a high probability of dying during the study. * patients who in the opinion of the investigator (for whatever reason) are thought to be unsuitable for the study.

Keywords: pediatrics lysosomal storage diseases gangliosidoses gm2 tay-sachs disease sandhoff disease infantile gm2-activator deficiency miglustat
oral ketorolac for arthroscopic rotator cuff repair

Conditions: Rotator Cuff Tear; Postoperative Pain

Summary: 1. the investigators aim to examine the use of iv and oral ketorolac as an adjunctive agent to the standard of care pain protocol for postoperative pain control following arthroscopic rotator cuff repair. 2. the investigators hypothesize that the use of iv and oral ketorolac in addition to the standard of care pain protocol will reduce postoperative opioid consumption following arthroscopic rotator cuff repair.


Eligibility criteria:
inclusion criteria 1. patients between the ages of 18 and 89 years old, male or female 2. patients undergoing primary shoulder arthroscopic rotator cuff repair exclusion criteria 1. patients below the age of 18 or above the age of 89 2. illiterate or non-english speaking patients 3. patients with contraindications to ketorolac 4. history of alcohol of drug abuse 5. chronic use of analgesic or psychotropic drugs 6. known peptic ulcer disease or bleeding diathesis 7. renal dysfunction

Keywords: rotator cuff tear postoperative pain
reduction in cardiovascular risk factors and visceral adipose tissue in men: separate effects of diet- and exercise-induced weight loss

Conditions: Obesity

Summary: the purpose of the trial was to examine the independent effects of equivalent diet- or exercise-induced weight loss on obesity and related cardiovascular health risk factors. we hypothesized that exercise would result in greater reductions in obesity and health risk factors that equivalent diet (caloric restriction).


Eligibility criteria:
inclusion criteria: * men between 20 and 60 yrs exclusion criteria: * smokers and diabetics

Keywords: obesity, exercise, diet, insulin resistance
pilot study on auricular vagus nerve stimulation effects in chronic diabetic wounds

Conditions: Chronic Diabetic Foot Ulcers

Summary: the purpose of this pilot study is to evaluate the effect of auricular autonomous nervous system stimulation on vital parameters of wound healing in diabetics. it is investigated if auricular vagal nerve stimulation has an effect on heart rate variability as well as peripheral local blood perfusion, and if this effect depends on the health status of the study participants (diseased/healthy).


Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2 * ulcus cruris (plantar) * min. 6 weeks of standard wound therapy without success * intact big toe on wound side exclusion criteria: * participation in a clinical trial in the last 5 weeks * confounding medical treatment, e.g. prostaglandin * vascular diseases other than peripheral arterial occlusive disease * diseases which may affect the autonomous nervous system or wound healing, except diabetic concomitant diseases (e.g., polyneuropathy, angiopathy) * drug abuse * active implanted devices * pregnancy or nursing

Keywords: vagus nerve stimulation effects on heart rate variability and peripheral blood perfusion
electrocardiogram (ecg) validation study

Conditions: Arrythmia

Summary: comparison of diagnostic electrocardiogram (ecg) signals


Eligibility criteria:
inclusion criteria * 18 years of age of older * able to read, understand, and sign informed consent documentation willing to wear the sansa device and 3-lead or 5-lead holter monitor simultaneously for 24- hours * in the opinion of the investigator, subject is willing to comply with the protocol exclusion criteria * noted deformities of the chest (e.g., pronounced scarring, pectus carinatum) that would interfere with sensor placement * broken or injured skin that would interfere with sensor placement, are known to experience adverse reactions to medical-grade adhesive * pacemaker dependent * females who are pregnant (self-reported)
the angioshield study feasibility ii

Conditions: Coronary Artery Disease

Summary: feasibility study to demonstrate the safety of the angioshield system to provide mechanical support for vein grafts used in cabg surgery.

the study is designed to investigate the feasibility of using an applied support (angioshield) to a saphenous vein to be used in coronary artery bypass surgery. it is a feasibility to determine safety prior to launching a larger pivotal study. the primary endpoint, 30-day safety, will be assessed by recording and reporting of adverse events during surgery and throughout the investigation until the 30-day follow-up visit. the secondary endpoints, long term safety and patency, will be assessed by recording and reporting of adverse events and graft patency (via serial ct angiograms) at the 30, 90, and 365 day follow-up visits.

Eligibility criteria:
inclusion criteria: subject will be eligible for inclusion in the investigation if he/she: 1. is between the ages of 18 and 80 years of age, inclusive 2. requires cabg surgery due to atherosclerotic coronary artery disease with minimum of two svgs, one used to bypass a stenosis in the main right coronary artery and one used to bypass a stenosis in the circumflex artery territory 3. is able to give their informed written consent 4. is willing and able to complete all follow-up visits and procedures 5. is to be treated via a medial sternotomy with cardio-pulmonary bypass during surgery 6. has adequate saphenous veins 7. is a candidate for transcatheter therapy, pci exclusion criteria: subject will be excluded from participation in the investigation if he/she: 1. is currently enrolled in another clinical investigation 2. is unable to tolerate or comply with required post-surgical medications or imaging (e.g., anticoagulation regimen; or known allergy to contrast agent) 3. is or may be pregnant or is lactating, or plans to become pregnant in the next 12 months 4. history of a hypercoagulable state 5. has had an acute mi within the last 21 days 6. has had a previous cabg 7. requires emergency surgery 8. has a left ventricular ejection fraction (lvef) less than 35 % 9. has a target vessel stenosis of less than 75% 10. has a transmural infarct of the target artery territory 11. has a serum creatinine greater than 1.5 mg/dl 12. is having concomitant -surgery of any kind 13. has had previous saphenectomy (see inclusion) 14. has saphenous vein sizes incompatible with treatment range (i.e., \ 5 mm inner diameter) 15. limb ischemia or non-healing ulcer 16. has moderate to severe copd defined as fev 1 of less than 1 liter 17. has had a cva in last 90 days 18. has diffuse disease in target vessel with an inadequate anastomotic touchdown site
safety of anti-depressant for chronic obstructive pulmonary disease (sad-copd)

Conditions: COPD; Anxiety; Depression; Stress; Interstitial Lung Disease

Summary: objective: determine whether treatment of perceived stress, anxiety, and depression with anti-depressant therapy improves dyspnea scores, 6-minute walk (6mw) distance and quality of life (qol) in patients with chronic obstructive pulmonary disease (copd) and ild (interstitial lung disease) undergoing pulmonary rehab. the study is a prospective, randomized, double-blinded, placebo-controlled study to assess the effect of an ssri on 6mw, dyspnea scores, and qol in copd and ild patients undergoing pulmonary rehab. thirty subjects that carry an icd-9 code diagnosis of copd and/or ild and ces-d (center for epidemiologic studies depression) score of \> 16 will be recruited from duke pulmonary rehab. multivariable regression models will be constructed to evaluate the relationship between perceived stress, anxiety, and depression with adjustments by race, gender, age, bmi and gold score. a multivariable regression model will be constructed to assess whether treatment of perceived stress, depression, and anxiety with antidepressant therapy (sertraline) is an effect modifier on 6mw distance and dyspnea scores in patients with copd or ild who are enrolled in pulmonary rehab. descriptive statistics will be used to examine the socio-demographic characteristic data. student t-tests will be performed to assess group differences in continuous data. categorical variables will be examined using the pearson's chi-squared test.


Eligibility criteria:
inclusion criteria: * male or female with an icd-9 code diagnosis of copd and/or ild * mild, moderate, or severe major depression symptoms based on center of epidemiologic studies depression (ces-d) score \> 16. * able to complete informed consent† * read and write in english exclusion criteria: * current treatment with antidepressants * current treatment with anti-psychotics * severe physical disability that would interfere with lung assessment * history of major psychiatric illness, including bipolar disorder, psychoses, and/or severe personality disorder. * active suicidal ideations * serious cognitive problems (dementia syndrome) or cognitive impairment defined as mmse \< 22 * recent loss of spouse within 6 weeks of study enrollment. * history of alcohol or drug dependence in the last 6 months. * pregnant women or nursing mothers * poorly controlled concomitant conditions that pose additional procedure risk as determined by the investigator.
neurocognitive exercises for ankle instability

Conditions: Ankle Sprains

Summary: in the general population, 19.0-26.6 per 1000 cases of ankle instability have been reported, while in the athletic population, the rate is 11.3 per 1000. ankle instability also predisposes individuals to recurrent instability, leading to persistent symptoms. after ankle injuries, temporary increases in afferent activity, along with long-term deficits in somatosensory information from ligaments, may cause central neuroplasticity that affects sensorimotor function. this central neuroplasticity can lead to permanent dysfunctions in the affected limb, thereby increasing the likelihood of developing and maintaining chronic ankle instability (cai). in addition to the association between impaired balance and reduced proprioception with cai, it has been reported that the central nervous system may fail to manage joint stress due to its inability to discern load on the ligaments. impaired neurocognition has been linked to decreased performance and higher rates of re-injury. deficiencies in neuromuscular control, motor learning, or other neurocognitive components related to an individual's performance and safety may affect the ability to respond appropriately in a dynamic environment. any deficiencies in these neurocognitive processes can hinder the successful completion of tasks. the aim of this study is to comparatively examine the effects of neurocognitively enriched rehabilitation versus traditional rehabilitation on re-injury risk, balance, and proprioception in individuals with a history of ankle instability.

voluntary participants who have been diagnosed with lateral ankle instability will be included in the study. signed voluntary consent will be obtained from participants. participants will be divided into two groups. study groups will be as follows: a) neurocognitive enriched exercise, b) multimodal exercise.

Eligibility criteria:
inclusion criteria: * the documented unilateral ankle instability confirmed through clinical examinations (drawer test, talar tilt test) and mri in cases requiring differential diagnosis. * a history of an initial ankle sprain occurring at least 6 months ago. * the presence of a recurrent sense of giving way that started at least 6 months ago and has been intermittently persistent. exclusion criteria: * presence of a history of previous surgery in the lower extremity. * identification of organic and non-organic lesions such as cartilage injuries, periarticular tendon tears, and impingement syndromes. * the existence of a fracture accompanying instability in the foot-ankle. * presence of congenital deformities in the foot-ankle. * diagnosis of talus osteochondral lesion. * diagnosis of ankle arthritis. * presence of medial ligament lesion. * existence of peripheral neuropathy. * presence of additional rheumatological diseases. * regular moderate-level exercise for at least 3 days a week in the last 6 months.

Keywords: neuroplasticity reinjury chronic ankle instability physiotherapy
trial of post-dated delayed antibiotic prescriptions

Conditions: Acute Upper Respiratory Tract Infections

Summary: delayed prescriptions have been shown to lower antibiotic use for upper respiratory tract infections (which are mostly viral). this trial will test the hypothesis that if the clinician post-dates the delayed prescription by 2 days, rather than dating it on the day the patient is seen, there will be a further drop in the rate of antibiotic use.

6 family doctors and 2 nurse practitioners in a small rural town will issue delayed antibiotic prescriptions to adult patients with new acute respiratory tract infections. the delayed prescriptions will be randomly dated for either the day of the office visit, or 2 days later. the 2 local pharmacies will note whether the prescription is cashed, and when. it is hypothesised that post-dating the prescription will result in a reduced cashing rate. each arm of the study (usual v post-dated) will contain 75 subjects. this sample will have the power to detect a 25% change in prescription use.

Eligibility criteria:
inclusion criteria: * adults aged 18 years or older * adults with an untreated upper respiratory tract infection * adults presenting for the first time to a family physician or a nurse practitioner exclusion criteria: * less that 18 years * having a clear indication for antibiotic therapy

Keywords: respiratory infections primary care antibiotics delayed prescriptions
identifying and treating depression in the orthopaedic trauma population

Conditions: Depression

Summary: the goal of this trial is to pilot a way for orthopaedic surgeons to safely screen for depression and provide treatment for depression with medication. the main questions it aims to answer are: 1. what are the outcomes of patients who screen positive for depressive symptoms and are prescribed either an selective serotonin reuptake inhibitors (ssri) or serotonin and norepinephrine reuptake inhibitors (snri). 2. what are the outcomes of patients who screen positive for depressive symptoms and choose not to pursue treatment with medication?

depression is common among orthopaedic trauma patients and associated with worsened outcomes including pain, opioid consumption, patient-reported outcomes ,complications, and length of stay. addressing depression, therefore, should lead to improved outcomes. orthopaedic surgeons may believe treating depression is outside their scope or that they lack tools to address depressive symptoms. in fact, only 45% of surgeons report they are likely to screen patients, and only 27% are likely to refer patients for psychological treatment.

Eligibility criteria:
inclusion criteria: * patients presenting to an orthopaedic trauma clinic for the first time following operative extremity fracture or any pelvis fracture * a score of greater than or equal to 5 on the patient health questionnaire-9 (phq-9) at first post- operative visit * age 18 or older * speak english or spanish exclusion criteria: * currently taking medication to treat depression * contraindication/allergy to one of the study medications * bipolar disorder of psychotic disorder * endorse suicidal ideation
pharmacoepidemiologic general research extension: pgrx-sibm study

Conditions: Sporadic Inclusion Body Myositis

Summary: sporadic inclusion body myositis (sibm) is a rare idiopathic inflammatory myopathy characterized by chronic proximal leg and distal arm asymmetric muscle weakness. its prevalence is estimated between 10 and 100 cases per million, over the age of 50. little is known about the natural course of the disease, the delay between onset and diagnosis, the patterns of disease management and treatment in routine practice, as well as the burden for patients. the objectives of the pgrx-sibm study will be to describe: * the epidemiology of the disease (estimation of the prevalence, age at onset, delay between onset and diagnosis, diagnosis process, etc.) * the patterns of disease management and treatment in routine practice * the burden of the disease for patients and their informal caregiver, as well as the quality of life of patients * the burden of the disease for informal caregivers this will be an observational (non-interventional), cross-sectional (transversal) study. study setting the pgrx-sibm will take place in france, italy, switzerland and spain. recruitment centers will be public and private practices and hospitals from urban or rural areas. in each recruitment center, at least one physician will act as a study investigator, in charge of identifying and recruiting patients. inclusion of patients patients will be included by their specialized physician (neurologist, internal medicine) during a regular outpatient visit, provided that they meet the following inclusion criteria: * the patient has been diagnosed with sibm, as per the physician judgement and regardless of the date of diagnosis * male or female * age ≥ 45 years old * the patient does regularly live in the country of inclusion * the patient or his/her proxy can read and respond to a telephone interview * the patient agrees to participate exclusion criteria will be: * the patient refuses to participate or the written consent form is not signed * the patient or his/her proxy cannot be reached by telephone. all eligible patients will be invited to participate in the study, during a 3 to 6-month period of time. the target sample size will be of 190 patients (≈15-20 in switzerland, ≈50 in spain, ≈50 in italy and ≈70-75 in france).


Eligibility criteria:
inclusion criteria: * the patient has been diagnosed with sibm, as per the physician judgement and regardless of the date of diagnosis * male or female * age ≥ 45 years old * the patient does regularly live in the country of inclusion * the patient or his/her proxy can read and respond to a telephone interview * the patient agrees to participate exclusion criteria: * the patient refuses to participate or the written consent form is not signed * the patient or his/her proxy cannot be reached by telephone.