Kornimate/medical-research-clean huggingface dataset:
a study of entresto in tetralogy of fallot (tof) and ebstein's anomaly (ea)

Conditions: Tetralogy of Fallot; Ebstein's Anomaly

Summary: the purpose of this study is to compare changes in rv structure and function, biomarkers, and patient reported outcomes between tof patients randomized to an arni vs placebo.


Eligibility criteria:
inclusion criteria: * tof or ea * age 18 or older exclusion criteria: * stage iv chronic kidney disease defined as creatinine clearance \<30 ml/min * hyperkalemia defined as serum potassium \>5.2 mmol/l, * hypotension defined as systolic blood pressure \<100 mmhg, * history of angioedema related to previous ace or arb therapy * patients diagnosed with diabetes using aliskiren, * pregnancy. * drug therapies * amifostine * droperidol * dantrolene * cyp3a4 inhibitors * obinutuzumab * aliskiren * lithium * sparsentan * ace inhibitor * arb * arni
validation of an electronic remote toxicity management system in cancer patients

Conditions: Cancer

Summary: to assess the psychometric properties (validity, reliability and responsiveness) of the questonco tool, an electronic remote toxicity management system, in adult cancer patients receiving an active anti-cancer treatment.

in this study, a mobile phone-based remote monitoring system (questonco application) was developed in order to enable the 'real-time' monitoring of patients' symptoms through use of eproms. in order to establish if this new application accurately and reliably identifies the anti-cancer treatment related symptoms, its psychometric properties (validity, reliability and responsiveness) have to be assessed. hypotheses: * the questonco application will be designed as a promising innovative tool with good psychometric properties in order to detect more rapidly the anti-cancer-related toxicity in adult cancer patients. * the questonco application is an accurate and reliable tool for the identification of the anti-cancer treatment related symptoms as much as current available questionnaires such as pro-ctcae and eortc qlc-qc30 the evaluation of the psychometric properties of the questonco application will be made in two phases. first, the patient's cognitive interviews will allow assessing the content validity of the items. then focus groups including patients and professional experts will determine the questonco application goals regarding the adverse symptoms management (recommendations provided within the application, connection with general practitioner, medical oncology team or emergency departments). this study will assess the validity, reliability and responsiveness of the questonco in a cohort of patients receiving anti-cancer treatments. the external validity will be directly compared to pro-ctcae (patient-reported outcome common terminology criteria for adverse events) and to eortc qlc-qc30 questionnaire.

Eligibility criteria:
inclusion criteria: * adults (≥18 years); * written and informed consent; * diagnosis of solid cancer; * metastatic or (neo)adjuvant anti-cancer treatment, including intravenous and/or oral treatments; * patient physically/psychologically fit to participate in the study; * patient able to understand, communicate and use the electronic device; * patient owning a smartphone or tablet with internet connection; * treatment supported by the french social security system. exclusion criteria: * unable patient for signing informed consent; * unable to understand, communicate and use the electronic device; * patient under trusteeship or guardianship; * patient under legal or administration protection.

Keywords: cancer active anticancer drug quality of life questonco application
hiv physician's survey

Conditions: HIV

Summary: this is a survey study to assess the variability in the current management of pregnancy, reproductive care and assisted reproductive technologies for hiv-positive individuals in canada to estimate interest for further projects.


Eligibility criteria:
inclusion criteria: * any hiv health care provider exclusion criteria: * none

Keywords: hiv hiv providers infectious disease hiv and pregnancy
clinico-biological correlation of severe asthma in children

Conditions: Severe Asthma

Summary: asthma is the most common chronic respiratory disorder in children. despite significant advances in understanding of asthma, available therapies fail to alter the natural history and progression of the disease. airway epithelial cells are continuously exposed to and injured by environmental irritants, such as viruses and pollutants, and as such are ideally situated to orchestrate airway function in response to these stimuli. severe or difficult-to-treat asthma in children is a complicated disorder characterized by ongoing symptoms and persistent airway inflammation and oxidant stress despite corticosteroid treatment. although severe asthma is likely a heterogeneous disorder, affected children similar clinical features, including gas trapping, bronchial hyperresponsiveness, and aeroallergen sensitization. however, the molecular and cellular pattern of inflammation in children with severe asthma are not uniform : some investigators have found increased eosinophils and th2 derived cytokines, others have noted noneosinophilic patterns with neutrophil activation. given the heterogeneity of the inflammatory response in children with severe asthma, additional methods to distinguish severe asthma are needed.


Eligibility criteria:
inclusion criteria: * children 0-18 years * patients followed regularly for at least one year. * the diagnosis of asthma is increased according to the criteria of the global initiative for asthma (gina): children with a history of recurrent episodes of bronchial obstruction. * children with severe asthma defined by the american thoracic society (ats): severe asthma is defined by the presence of a major criterion: the need for high doses of inhaled corticosteroids (budesonide dose equivalent 400 micro g) and least two of the five minor criteria: * the daily use of beta 2 long-acting or short-term daily action (\<4 years) or anti-leukotrienes associated with inhaled corticosteroids daily or almost daily use of beta-2 short-acting permanent-bronchial obstruction (fev \<80% predicted fev) * at least one emergency department visit for asthma exacerbations in france * at least 3 courses of oral corticosteroids per year exclusion criteria: * parents' refusal to participate in the study * refusal children to participate pathology underlying cardiac, neuromuscular, immunodeficiency
the effect of an exercise program on the health-quality of life (hql) in older adults

Conditions: Healthy

Summary: the present study aimed to investigate the effect of exercise program on health-quality of life (hql) in older adults.

the questionnaire consisted of demographic data (such as age, gender, educational level, and employment) and the leipad questionnaire used to measure hql.

Eligibility criteria:
inclusion criteria: * sixty healthy adults volunteers * over the age of 55 years exclusion criteria: * neurological disorder * acute heart impairment * unstable chronic illness * severe musculo-skeletal impairment

Keywords: exercise
depth electrode detection of cortical spreading depolarization after traumatic brain injury

Conditions: TBI (Traumatic Brain Injury)

Summary: preliminary evaluation of depth electrode recording and novel algorithms to determine cortical spreading depolarization's (csd) following traumatic brain injury (tbi) requiring neurosurgical intervention.

during the standard of care external ventricular drain (evd) placement, a depth electrode with minimal modification to the standard surgical procedure will be placed. this will allow electrocorticogram (ecog) recordings. an ecog will be reviewed by a study neurosurgeon to understand the association between cortical spreading depression and pathological findings on imaging. the recordings help create a novel algorithm in order to detect csd's. this may ultimately provide significant benefit to society through the diagnosis and treatment of secondary injury associated with traumatic brain injury.

Eligibility criteria:
inclusion criteria: * patient recommended to undergo evd placement for the monitoring and possible treatment of intracranial pressure (icp) after tbi exclusion criteria: * contaminated scalp lacerations * known systemic infection * non-english speaking * fixed, uncorrectable coagulopathy
bacillus cereus invasive infections in preterm neonates hospitalized in french hospitals

Conditions: Sepsis; Infections

Summary: background. bacillus cereus group (bc) comprises twenty-six closely related species of spore-forming environmental bacteria. recently, increased sepsis and septic shock caused by bc were reported in preterm neonates (pn), and the mortality rate can reach up to 30%. using whole genome sequencing (wgs) increasingly used to characterize bc strains, the team aimed to determine an accurate identification to the species level of the strains involved in bc invasive infections in preterm neonates in france and study their virulome profile.methods. the team performed wgs for 40 neonate clinical strains responsible for invasive infections in pn. a screening of virulence genes was performed to characterize strains associated with poor prognosis. clinical data were collected and all clinical and genomic findings were analyzed for risk factors for death. "


Eligibility criteria:
inclusion criteria: * premature newborn (i.e born before 37 last menstrual periods) with invasive infection caused by b. cereus (strains isolated from blood culture and cerebrsopinal fluid) exclusion criteria: * none
comparing the effect of tap-catheter and epidural catheter on postoperative pain after open gynecologic surgery

Conditions: Pain, Postoperative

Summary: this study compares the effect on postoperative pain of bolus administration of ropivacaine in transversus abdominis plane catheter and continuous bupivacain-infusion in epidural catheters following open gynecologic surgery.the study is double blind. the hypothesis is that the effect of the two modes of pain treatment are equal.

patients for open gynecologic surgery will all receive both an epidural catheter and bilateral transversus abdominis plane (:tap) catheters. after randomization in to two groups the patients receive either 1) intermittent boluses of ropivacaine in the tap-catheters and isotonic potassium chloride-infusion i the epidural catheters or 2) intermittent isotonic potassium chloride-boluses i the tap-catheters and bupivacain-infusion in the epidural catheters. the investigators record pain-score and consumption of opioids in the first 24 hours postoperatively as well as thermoanalgesia at dermatome-levels th10-th12. the investigators assume that the effect on postoperative pain after open gynecologic surgery is equal in the two groups.

Eligibility criteria:
inclusion criteria: * patients scheduled for open gynecologic surgery * acceptance to participate exclusion criteria: * allergies to local analgetics * daily use of strong opioids

Keywords: transversus abdominis plane catheter
ondansetron oral versus orally disintegrating tablets (odt)

Conditions: Acute Gastroenteritis

Summary: in children aged 3 months to 10 years who present to the pediatric emergency department (ped) with recent, significant vomiting and moderate dehydration, is treatment with ondansetron orally disintegrating tablet (odt) better tolerated than treatment with ondansetron oral solution (os)? our hypothesis is that children who receive ondansetron odt will have 10% less vomiting within 15 minutes of administration than those receiving ondansetron os.

vomiting related to viral gastroenteritis is the most common presentation to the alberta children's hospital pediatric emergency department. recently, a clinical pathway was implemented to improve the care and flow of patients with vomiting and/or diarrhea through the department. administration of an antiemetic, ondansetron, is an integral part of improving the hydration status of children managed by the pathway. however it is not know whether oral solution or oral disintegrating tablets are better tolerated in children who have active vomiting. the investigators aim to show that children receiving oral disintegrating tablets have less vomiting immediately after medication administration than children receiving oral solution. by demonstrating this improved tolerability the investigators will provide health care providers the stimulus for implementing ondansetron oral disintegrating tablets into their practice for children with active vomiting.

Eligibility criteria:
inclusion criteria: * children aged 3 months to 10 years with recent, * significant vomiting and moderate dehydration who are managed according to the alberta health services (calgary and area) acute childhood vomiting \& diarrhea pathway. * the following definitions are used to determine inclusion according to the pathway: recent, significant vomiting - vomiting at least 6 episodes in the past 6 hours and at least once in the past hour; moderate dehydration (gorelick score 2) - two of the following: capillary refill time greater than 2 seconds, absence of tears, dry mucous membranes, ill general appearance. exclusion criteria: * children who are excluded from the alberta health services (calgary and area) acute childhood vomiting \& diarrhea pathway. * these criteria include: vomiting or diarrhea for greater than 7 days, localized abdominal pain, chronic medical conditions affecting major organ systems (ex, diabetes, pku, immunodeficiency), likely gi obstruction (abdominal distension, bilious vomiting, absent bowel sounds), weight less than 8kg. children who have received anti-emetics at home will not be excluded but will be tracked.
endoscopic biliary radiofrequency ablation of malignant distal common bile duct strictures

Conditions: Pancreatic Cancer; Cholangiocarcinoma

Summary: malignant bile duct obstruction is a common sequela of pancreatic cancers or distal bile duct cancers, and its development can hinder the use of chemotherapy, decrease patient quality of life, and decrease survival. to relieve obstructive jaundice as a result of the obstruction, endoscopic stent placement is usually required. the use self-expandable metal stents (semss) have been shown to result in a longer patency times as compared with plastic stents. however, despite improvements in materials and stent design, stent obstruction still occurs in 13% to 44% of the patients. tumor in-growth is the most common mechanism of stent obstruction. recently, the use of endoscopic biliary radiofrequency ablation (ebrfa) have been described in patients suffering from inoperable malignant distal common bile duct (cbd) obstruction. the procedure uses heat energy to cause local tumour tissue death, resulting in re-opening of the bile duct lumen. the procedure has the potential of reducing the rate of stent obstruction after sems and also prolonging survival. the safety profile appears to be comparable that of placement of sems alone without added complications (\<10%). the aim of the current study is to compare the efficacy of ebrfa with the addition of sems to sems alone in a randomized controlled trial.we hypothesize that the application of ebrfa can reduce recurrent biliary obstruction after sems.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old with informed consent 2. histologically (preferred) or radiologically confirmed distal malignant bile duct tumors 3. inoperability by staging, comorbidities or patient wishes 4. distal tumors 2cm away from the portal hilum 5. bilirubin \> 50umol/l at diagnosis exclusion criteria: 1. periampullary tumours 2. multiple hepatic metastases with significant blockage of one or more liver segments (if no segment blockage, metastasis is not an exclusion criteria) 3. presence of main portal vein thrombosis 4. prior sems placement 5. prior billroth ii or roux-en y reconstruction 6. history of bleeding disorder or use of anticoagulation 7. child's b/c cirrhosis 8. pregnancy 9. performance status ecog ≥3 (confined to bed / chair \> 50% waking hours) 10. presence of other malignancy 11. presence of gastric outlet obstruction 12. life expectancy \< 3months

Keywords: pancreatic cancer cholangiocarcinoma endoscopic radiofrequency ablation
treatment of plantar fasciitis with injection af platelet-rich plasma into the origin of the plantar fascia

Conditions: Plantar Fasciitis

Summary: the purpose of our study is to determine whether one injection with plasma into the origin of the plantar fascia is an effective treatment of plantar fasciitis. 90 patients will be randomized into three groups. 30 patients will be treated with one plasma injection, 30 patients will be treated with one injection with saline and 30 patients will do physiotherapy and use heel cups. the two groups who receive injections will do the same physiotherapy and use heel cups, as the conservatively treated group. both groups randomized to receive an injection will have a 10 ml blood sample taken from their cubital vein. the sample is centrifuged for 5 minutes at 5000 rpm. no additives are added. 3 ml of plasma i obtained, and the syringe i blinded. is the patient randomized to receive an injection with saline, a similar syringe is blinded with 3 ml of saline. the injection into to the origin of the plantar fascia i done 10 minutes after the sample of blood is obtained. the content of the syringe i blinded to both the investigator and the patient. the injection i performed from the medial aspect of the heel under guidance of ultrasound. no local/systemic analgetic is used. the content of the syringe is spread using peppering technique into the origin of the plantar fascia. patients will do questionnaires at inclusion and after 1, 2, 3, 6 and 12 months. the questionaires will be foot function index and sf-36 as well as questions about their use of analgetics, use of heel cups and intensity of their physiotherapy


Eligibility criteria:
inclusion criteria: * between 18 and 70 of age * sore at the insertion of the plantar fascia on calcaneus * a vas score of at least 4 at the insertion of the plantar fascia on calcaneus taking the first step in the morning * symptoms for 6 to 12 months * ability to understand danish and give informed consent exclusion criteria: * previously operated in the same ankle or foot * pain anywhere else in the foot on palpation otherwise than at the insertion of the plantar fascia on calcaneus * inflammatory disease * diabetes * formerly rupture of the achilles tendon * formerly treated with plasma injections * ongoing infection treated with antibiotics * treated with steroid during the trial * treatment of the plantar fasciitis exceeding conservative treatment * use of crutches, walker or similar * pregnancy

Keywords: plantar fasciitis plasma prp heel pain
health benefits of vitamin d and calcium in women with pcos (polycystic ovarian syndrome)

Conditions: Polycystic Ovarian Syndrome; Vitamin D Deficiency

Summary: the investigators conducted a prospective un-blinded pilot study of vitamin d plus calcium (ca) supplementation in overweight (bmi \> 27) premenopausal women diagnosed with polycystic ovarian syndrome (pcos), as defined by the rotterdam criteria, 2003, and who were deficient in vitamin d as reflected by serum 25-hydroxy (25-oh) vitamin d (serum levels \< 20 ng/ml).

we had hypothesized that in women with pcos, administering optimal daily doses of vitamin d3, as recommended by the national academy of sciences, 2000iu cholecalciferol and 1000mg of calcium, both per oral (po), over a three month period will improve their metabolic picture, and possibly hormone profile. over the course of the trial, after the first 5 subjects had completed 3 month intervention,we observed that daily 2000iu d3 dosing regime was inadequate in normalizing vitamin d status in the study population; the dosing regimen was therefore modified to include weekly supplementation with 50,000iu d2 in addition to daily dosing with 2000iu d3.

Eligibility criteria:
inclusion criteria: * premenopausal women (ages 18-40 years) with normal thyroid function and prolactin levels. * pcos diagnosis based on rotterdam criteria: presence of at least 2 of the following criteria: * oligomenorrhea-menstrual cycles \> 35 day intervals * hyperandrogenemia (elevated serum testosterone \[free or total\] \&/or androstenedione levels) or features of hyperandrogenism i.e. acne or hirsuitism \[ferriman-gallaway score \> 3\] * polycystic ovaries on vaginal ultrasound as defined by eshre/asrm criteria (ovarian volume ≥ 10ml or ≥ 12 follicles of diameter between 2-9mm in at least one ovary) * overweight (bmi ≥ 27 kg/m2) * biochemical evidence of vitamin d insufficiency (i.e. serum 25 ohd levels \< 20ng/ml) exclusion criteria: * pregnancy * known causes of oligomenorrhea other than pcos, e.g. hypothyroidism/cushing's disease/late onset congenital adrenal hyperplasia (fasting 17-alphahydroxyprogesterone levels \< 200ng/dl) * use of hormonal treatment (birth control pill/patch/depot medroxyprogesterone/medroxyprogesterone) within 3 months of the study onset. * use insulin sensitizers (metformin, sulfonylureas, tzds, incretins) within 3 months of the study onset. * use of lipid lowering agents or medications known to influence insulin sensitivity (e.g. niacin, corticosteroids, beta blockers, calcium channel blockers, thiazide diuretics) or influence serum androgens (estrogen, anti-androgens, androgens) within 3 months of the study onset. * known history of renal calculi or current use of calcium and vitamin d supplements. * spanish speaking.