Kornimate/medical-research-clean huggingface dataset:
feature assessment study for indications based programming

Conditions: Ventricular Tachycardia; Ventricular Flutter; Ventricular Fibrillation; Heart Failure

Summary: the purpose of this evaluation is to assess the acceptance level of specific programming recommendations based on the patient's clinical needs and primary indications when using the feature 'indications based programming' (ibp) available in the zoomview software application for the teligen dr / vr and cognis family of devices compared to daily life programming chosen by physicians.

"this study will focus on documenting the final parameter changes that are made in comparison to the ibp recommendations for a specific cardiovascular and arrhythmia history. it will therefore compare the device settings that were finally programmed during the last available follow up procedure to the last available parameter recommendations of ibp. ibp was designed to facilitate programming by providing customized parameter settings based on a patient's clinical needs and primary indication. in order to further enhance the ibp feature for future device generations, additional data may be collected and evaluated on: * physician perception and satisfaction with the new user interface (nui) of the programming application; * motivation for adapting ibp recommendations for the final programming of the device; * device data that can be retrieved from patient data disks that may include but is not limited to, arrhythmia episode detail, pacing counter data; total and individual therapy data"

Eligibility criteria:
inclusion criteria: * indicated for implantation of an icd or crt-d device according local hospital implant criteria guidelines * implanted or intended to be implanted with any ce-marked device approved for implant from the teligen (single or dual chamber icd) or cognis (crt-d) family during first implant (no replacements) * geographically stable patients who are available for follow-up at a study centre * age 18 or above, or of legal age to give informed consent specific to national law exclusion criteria: inability or refusal to sign the patient informed consent * pregnant or planning to become pregnant * replacement device * enrolment in another clinical trial, study or evaluation * estimated life expectancy of less than six months per discretion of physician
coronary sinus reducer for treatment of refractory angina - cosira

Conditions: Refractory Angina

Summary: the purpose of this study is to determine if the reducer is safe and effective in treating the symptoms of refractory angina in patients that suffer from refractory angina who demonstrate reversible ischemia.


Eligibility criteria:
inclusion criteria: 1. patient is older than 18 years of age 2. symptomatic cad with chronic refractory angina pectoris classified as canadian cardiovascular society grade iii or iv despite attempted optimal medical therapy for thirty days prior to screening 3. patient has limited treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention 4. evidence of reversible ischemia that is attributable to the left coronary arterial system by dobutamine echo 5. left ventricular ejection fraction greater than 25% 6. male or non-pregnant female (nb: females of child bearing potential must have a negative pregnancy test) 7. patient understands the nature of the procedure and provides written informed consent prior to enrollment 8. patient is willing to comply with specified follow-up evaluation and can be contacted by telephone exclusion criteria: 1. recent (within three months) acute coronary syndrome 2. recent (within six months) successful pci or cabg 3. unstable angina (recent onset angina, crescendo angina, or rest angina with ecg changes) during the thirty days prior to screening 4. de-compensated congestive heart failure (chf) or hospitalization due to chf during the three months prior to screening 5. life threatening rhythm disorders or any rhythm disorders that would require placement of an internal defibrillator and or pacemaker 6. severe chronic obstructive pulmonary disease (copd) as indicated by a forced expiratory volume in one second that is less than 55% of the predicted value 7. patient cannot undergo exercise tolerance test (bicycle) for reasons other than refractory angina 8. severe valvular heart disease 9. patient with pacemaker or defibrillator electrode in the right atrium, right ventricle, or coronary sinus 10. patient having undergone tricuspid valve replacement or repair 11. chronic renal failure (serum creatinine \>2 mg/dl), including patients on chronic hemodialysis 12. moribund patients, or patients with comorbidities limiting life expectancy to less than one year 13. contraindication to required study medications that cannot be adequately controlled with pre-medication 14. known allergy to stainless steel or nickel 15. contraindication to having an mri performed (nb: cardiac mri subset patients only) 16. currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints 17. mean right atrial pressure higher than or equal to 15 mmhg 18. patient with anomalous or abnormal cs as demonstrated by angiogram. abnormality defined as: abnormal cs anatomy (e.g., tortuosity, aberrant branch, persistent left svc) and/or; cs diameter at the site of planned reducer implantation less than 9.5 mm or greater than 13 mm
impact of a booklet-question list on cancer patients or their families seeking prognostic information during a palliative care consultation

Conditions: Metastatic Cancer; Palliative Care

Summary: prospective, randomized, multicentre phase iii study to evaluate the level and type of information requested by patients or families during a palliative care consultation after they have been given the booklet-question list (bql).


Eligibility criteria:
inclusion criteria: * patient over the age of 18 years, * patient who has signed the informed consent form after being given a written information sheet * patient followed for metastatic cancer with or without specific treatment, with a limited life expectancy * patient referred to the palliative care team. * french-speaking patient exclusion criteria: * cognitive disorders * documented psychiatric disorders or marked psychological fragility

Keywords: palliative care cancer quality of life
validation of a nociception monitor in healthy volunteers

Conditions: Pain

Summary: anesthesiology daily practice consists in management of sedation, immobility and analgesia. the monitoring of this last component remains largely based on indirect signs with poor sensitivity and specificity such as heart rate and blood pressure. accordingly, there is an increased demand for more accurate analgesia monitors. several parameters have been studied in the recent years such as spectral entropy, skin conductance, pupillometry or heart rate variability (hrv). the hrv is influenced by the balance of sympathetic and parasympathetic tones, and is therefore influenced by pain and analgesia. mdoloris medical systems sas, located in lille, france, had developed a monitor called physiodoloris (tm) that uses an analysis of the hrv to generate a clinically useable index, the analgesia-nociception index (ani). the ani varies from 0 to 100, a lower number indicating less parasympathetic tone. it has been shown in previous studies under general anesthesia to decrease at the moment of surgical incision and pneumoperitoneum inflation and to increase with opioids administration. the purpose of this study is to show a correlation between the variation of the ani with pain scores in awake healthy volunteers who are subjected to standardized painful stimuli of increasing intensity. the investigators hypothesize that an increasing pain score will correlate with decreasing ani values.

see above

Eligibility criteria:
inclusion criteria: * volunteers aged 18-80 years old exclusion criteria: * heart disease * neurological disease * allergy to cutaneous electrodes * chronic pain and/or chronic analgesics consumption * medication affecting the autonomic nervous system * inability to understand a numeric rating scale (nrs)

Keywords: analgesia monitoring analgesia nociception index ani physiodoloris pain
tourniquet in total knee replacement short and long duration: a comparative study

Conditions: Tourniquet Palsy

Summary: total knee arthroplasty (tka) is an effective treatment in severe osteoarthritis. we aim to compare the advantages and disadvantages related to the duration of tourniquet application in tka surgeries.

total knee arthroplasty (tka) is considered an effective method in relieving pain and regaining function in severe osteoarthritis patients; however, it is associated with increased blood loss risk which can increase the need for blood transfusion. tourniquet use during surgery is controversial as it provides a clear visualization which decreases the blood loss and ensures proper cementation which makes it used frequently during tka. however, its use is associated with complications like nerve palsy, thigh pain, swelling, joint stiffness, wound complications, subcutaneous fat necrosis, vascular injury, deep venous thrombosis (dvt), and prolonged duration of quadriceps recovery. the proper duration of tourniquet application is also controversial as it affects tka postoperative outcomes as increasing tourniquet application duration can aggravate the complications risk because of the increased tissue exposure to ischemia. therefore, minimization of the tourniquet application duration is important which makes researchers investigate if tourniquet application during the cementation process only in tka could decrease the complications and fasten the recovery. limited tourniquet application during tka decreased swelling and joint pain while it was not associated with blood loss, recovery, or operation time. while applying a tourniquet only in cementation could reduce blood loss, fasten the recovery period, and reduce pain after tka surgery. however, decreasing tourniquet application to be only during cementation was associated with increased blood transfusion risk which indicated that this approach was impractical if there was not any improvement in recovery. therefore, a balance should exist between the increased blood loss and blood transfusion risk during cementation tourniquet application. therefore, the application time of a tourniquet during cementation in tka is controversial and no meta-analysis compared using a tourniquet only to the long tourniquet use in tka surgeries. therefore, randomized controlled trials (rcts) are needed to compare which strategy is better which made us perform this study to compare both strategies regarding pain, oxford knee score (oks), hospital stay, pain, knee society score (kss), blood loss, and range of motion (rom).

Eligibility criteria:
inclusion criteria: * we included symptomatic grade iv knee primary osteoarthritis cases who were candidates for tka surgery exclusion criteria: * we excluded patients with a history of post-infection or traumatic osteoarthritis, knee deformity, hematological diseases, currant infection focus, immune-suppression, or inflammatory arthritis.
incorporation of photobiomodulation therapy in an exercise program with blood flow restriction for knee osteoarthritis

Conditions: Osteoarthritis, Knee; Physical Therapy Modalities

Summary: knee osteoarthritis (oa) is one of the most common musculoskeletal disorders in the world. the aim of this project is to evaluate the additional effect of photobiomodulation therapy on the quadriceps muscle and knee joint in a blood flow restriction exercise program for individuals with knee oa. to this end, volunteers will be selected at random, aged between 40 and 65 years with pain in one knee, at least in the last 6 months, diagnosed with unilateral knee oa based on the criteria established by the american college of rheumatology and radiographic confirmation for grades 2 or 3 of the kellgren-lawrence classification, will be randomized into the following groups: (exercises with blood flow restriction, n = 20), (exercises with blood flow restriction + photobiomodulation, n = 20) and exercises with blood flow restriction + placebo photobiomodulation (n = 20). 12 consecutive weeks of treatment will be carried out, with the volunteers being evaluated before and after, using the following instruments: the western ontario and mcmaster universities osteoarthritis index (womac), sit and stand test, timed up and go (tug), numerical scale pain assessment (end), pain-to-pressure threshold (ldp), skin temperature: quadriceps musculature, knee joint and maximum voluntary isometric contraction (mvic) of the muscles: quadriceps, middle gluteus. for data analysis, normality test will be used to verify the data distribution and statistical test consistent with the appropriate comparisons within and between groups, thus, two factors are considered in the comparisons, time and group. a significance level of 5% will be adopted.


Eligibility criteria:
inclusion criteria: * knee pain to at least six months and minimum of 4 points in pain scale * diagnosis of unilateral knee oa based on criteria established by the american college of rheumatology and radiographic confirmation for grades 2 or 3 of the kellgren-lawrence classification. exclusion criteria: * score on the numerical visual analog of knee pain less than 1 or greater than 8; * knee trauma; * cognitive impairment; * psychological disorder; * neurological disorder (sensory or motor); * cancer; * diabetes any acute adverse health condition; * signs of hip oa; * sings cardiopulmonary disease that could prevent exercise and use of a walking assist device. * have undergone any form of treatment involving: physiotherapy, intra-articular corticosteroids, anti-inflammatories or chondroprotectors in the last year. * if the size of the circumference of the thigh and knee does not allow the proper positioning of the photobiomodulation mesh.
ruxolitinib for acute respiratory disorder syndrome due to covid-19

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2; SARS-CoV2

Summary: the covid-19 pandemic has had a dramatic effect in public health worldwide. in brazil, there have been more than 2 million confirmed cases and over 75,000 deaths since february 26, 2020. based on reports of a hyperinflammatory state associated with covid-19, the use of immunosuppressive drugs may be efficacious in the treatment of this disease. jak inhibitors have been shown to harness inflammation in a number of different pathologic conditions. the aim of the present study is to evaluate the efficacy and safety of jak inhibitor ruxolitinib in patients with acute respiratory distress syndrome due to covid-19.


Eligibility criteria:
inclusion criteria: * patients hospitalized with sars-cov-2 pneumonia confirmed by rt-pcr or serology (iga); * pao2/fio2 \< 300 (not fully explained by heart failure or volume overload) or spo2 \< 90% on room air. exclusion criteria: * symptom onset \> 14 days; * neutrophil count \< 1,000/mm3; * platelets \< 50,000/mm3; * icu care at enrollment; * on invasive mechanical ventilation at enrollment; * current use of experimental therapy for covid-19 (except: azithromycin or corticosteroids) * uncontrolled arterial hypertension; * current or previous use of systemic immunosuppressive therapy in the last 30 days; * pregnancy or lactation; * estimated creatinine clearance \< 30 ml/min or receiving crrt or intermittent hemodialysis; * allergy to ruxolitinib; * active tuberculosis; * hiv seropositivity; * prior history of progressive multifocal leukoencephalopathy; * use of any jak inhibitor in the last 30 days before study enrollment; * not qualifying according to investigators' perception.

Keywords: sars-cov2 severe acute respiratory syndrome coronavirus 2 janus kinase inhibitors safety clinical efficacy clinical trial
a study of istradefylline (kw-6002) for the treatment of parkinson's disease

Conditions: Parkinson's Disease

Summary: to establish the efficacy of 40 mg/day doses of istradefylline for the change in unified parkinson's disease rating scale (updrs) part-iii (motor examination) score in patients with parkinson's disease (pd).

to establish the efficacy of 40mg/d doses of istradefylline for the change in updrs part-iii (motor examination) score in patients with parkinson's disease (pd). patients who meet entry criteria will be randomly assigned to receive study drug in 1 of 2 arms: condition a (doses of 40mg/d istradefylline) in period 1 followed by condition b (matching placebo) in period 2 (putting 4 weeks interval phase between two periods ) or condition b in period 1 followed by condition a in period 2(putting 4 weeks interval phase between two periods ). patients will be participated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.

Eligibility criteria:
inclusion criteria: 1. uk parkinson's disease society (ukpds) brain bank criteria (step 1 and 2) for pd. 2. pd stages 1-3 for modified hoehn and yahr scale. 3. be at least 30 years of age. exclusion criteria: 1. neurosurgical treatment for pd. 2. history of psychosis. 3. diagnosis of cancer within 5 years. 4. diagnosis of clinically significant illness of any organ system. 5. mini-mental status examination score of 25 or less. 6. taking any excluded medications. 7. history of drug or alcohol abuse or dependence within the past two years. 8. history of seizures or neurological malignant syndrome. 9. clinical depression. 10. pregnant or lactating females.

Keywords: parkinson's disease monotherapy
clinical evaluation of promis in ckd

Conditions: Chronic Kidney Diseases

Summary: the purpose of this study is to evaluate the clinical validity of a set of promis pediatric person-reported outcome measures in patients with chronic kidney disease. the evaluation includes longitudinal assessments of how measures change in association with clinical changes.

the national institutes of health (nih)-sponsored patient-reported outcomes measurement information system (promis) network has developed over 20 pediatric instruments, both child-report and parent-proxy editions. cross-sectional evaluations of the validity of the instruments have established that they are ready for integration into clinical research and practice. the next step in their ongoing evaluation is to assess their prospective clinical validity in a variety of health conditions. this study addresses the clinical evaluation of the measures in children with chronic kidney disease (ckd). through baseline surveys and six follow-up surveys over a two-year period, investigators are collecting self-report (child) and parent-proxy report of 11 pediatric promis measures. each of these promis measures is described in the main outcome measures section. investigators are also collecting assessments of disease activity from clinical data. the selection of self-report and parent proxy patient-reported outcome (pro) measures were determined through qualitative content validation. the analytic goal of this project is to evaluate baseline (cross-sectional) and longitudinal associations between promis pediatric outcome measures and changes in the clinical status of patients with ckd. our primary hypothesis is that as kidney function declines, self-reported health will worsen.

Eligibility criteria:
inclusion criteria: * child is 8-21 years old at time of enrollment * child is a chronic kidney disease in children (ckid) patient or a child who receives pediatric nephrology care at a ckid site that participates in pedsnet, a national pediatric learning health system * child seen by a pediatric nephrologist in the past 24 months * child has two egfr readings (computed from serum creatinine) between 6-89 ml/min at least 3 months apart (egfr of this level indicates ckd) * child speaks english * parent is the parent or legal guardian for the child * parent speaks english exclusion criteria: * child is currently receiving dialysis * child received a kidney transplant * child has a parent-reported cognitive limitation that would preclude them from completing a questionnaire * child does not speak english * parent does not speak english * parent is not the parent of legal guardian for the child
education program for cardiac patients

Conditions: Percutaneous Coronary Intervention; Coronary Artery Disease

Summary: the purpose of this study is to elaborate an educative program that includes telephone follow-up and assess its impact on the perceived health status of patients submitted to percutaneous coronary intervention.


Eligibility criteria:
inclusion criteria: * adult patients (18 years or more) of both sexes * being submitted to the first coronary artery bypass graft surgery between april 2011 and july 2012 * having a properly functioning residential phone line exclusion criteria: * no cognitive condition to participate (assessed through the mini-mental state examination - mmse) * illiterate participants who did not reach the minimum score 13 on the mmse * participants with one to seven years of education who did not reach the minimum score 18 on the mmse * participants with eight or more years of education who did not reach the minimum of 26 points on the mmse
the role of osteopathic treatment in the axial variations of the lumbar spine: rct

Conditions: Low Back Pain

Summary: the aim of the present study is to determine whether there is a relationship between osteopathic treatment and the change of physiological axes of the lumbar spine, through the use of dynamic magnetic resonance imaging.


Eligibility criteria:
inclusion criteria: * will be admitted patients of both genders * patients with chronic low back pain at baseline * patients aged between 18 and 35 years exclusion criteria: * patients diagnosed with the disease of the musculoskeletal system or congenital malformation of the column * patients with disorders of the pelvic floor, or who have undergone surgery of the reproductive system * patients with neurological disorders that can cause painful symptoms of lumbar segment

Keywords: osteopathic manipulative treatment low back pain dynamic mri