Kornimate/medical-research-clean huggingface dataset:
impact of postoperative medical equipment removal/insertion on parental anxiety in pediatric cardiac intensive care unit

Conditions: Parents; Anxiety Postoperative

Summary: a lot of observationnal studies describe parental stressors in picu/pcicu, but none studied, prospectively, the links between medical equipment removal/insertion and anxiety modulation. the primary objective is to identify the impact of medical equipment removal/insertion on the stai-y score (anxiety) the secondary objective is to identify the parental anxiety determinant (via vas).

a lot of observationnal studies describe parental stressors in paediatric intensive care unit, but none studied, prospectively, the links between medical equipment removal or insertion and anxiety modulation. the primary objective is to identify the impact of medical equipment removal or insertion on the stai-y score (anxiety) the secondary objective is to identify the parental anxiety determinant (via visual analog stress scale. parents will fill out questionnaire upon arrival in the intensive care unit when reaching the bedside of their hospitalized child right after the elective cardiac surgery. then after each equipment removal or insertion they will be asked to fill out again the same questionaire.

Eligibility criteria:
inclusion criteria: * parents/legal tutor of minor patient (congenital cardiopathy) with elective hospitalization in pcicu for surgical procedures exclusion criteria: * parents no french speaking * child hospitalized for cardiac catheterization * child hospitalized for berlin heart insertion * child hospitalized for heart transplantation
voluntary activation during isokinetic contractions in subjects with neuromotor disorders

Conditions: Multiple Sclerosis; Poststroke/CVA Hemiparesis; Parkinson Disease; Knee Impairment

Summary: activation is the amount of voluntary recruitment of a muscle during voluntary contraction. full activation implies the recruitment of all muscle fibres at their tetanic frequency. in healthy subjects, and even in sports performances, full activation may be rarely achieved despite a subjectively maximal effort. highly decreased activation has been observed in patients affected by various orthopaedic and neurological disorders. in these subjects, paresis may be caused or aggravated by primitive impairments of the central nervous system and/or, by stimuli arising from peripheral damaged tissues that inhibit the corticospinal or the intraspinal recruitment of motoneurones ("arthrogenous muscle weakness"). there are numerous investigations in the literature on activation measured during isometric contractions, while they are substantially missing as far as isokinetic concentric contractions are concerned. there are reasons to suppose that, contrary to what has been demonstrated for healthy subjects, in patients with various motor impairments the activation is diminished the more, the higher is the joint rotation speed. the present study aims to investigate the amount of activation of the quadriceps femoris during subjectively maximal isometric contractions at 40° knee flexion (0°=complete extension) and isokinetic concentric contractions at an angular velocity of 100°/s in patients with various orthopaedic and neurologic conditions. activation will be measured on an isokinetic dynamometer, through the "interpolated twitch technique". this consists of stimulating a representative sample of the muscle belly through an electric shock. if the shock does not generate an extra force during contraction, all muscle fibres belonging to the sample reached by the electric shock can be claimed to be recruited at their tetanic frequency. otherwise, following the stimulus, a twitch can be observed revealing submaximal voluntary recruitment of the muscle.


Eligibility criteria:
inclusion criteria: * age between 18 and 70 years old; * ability to sign the informed consent form; * ability to understand the instructions and to complete the motor task; * voluntary knee flexion-extension range of at least 70°; * maximal extension of angle \< 30° (0°=full extension, 180° sagittal tibio-femural angle). exclusion criteria: * pregnancy; * a history of epilepsy (to avoid the risk for seizures triggered by the stimuli); * mini mental state examination ≤27/30; * implanted electro-sensitive devices; * any orthopedic condition limiting the articular mobility or muscular strength of the lower limbs; * current treatment with oral anticoagulant therapy (to avoid the risk for muscle hemorrhage); * medium/serius osteoporosis (femoral bone mineral density on the affected side, t-score \< (-3.5)); * familiarity with the testing method.

Keywords: voluntary activation lower limb interpolated twitch technique rehabilitation
foodlit-trial: digital behaviour change intervention to improve food literacy amidst the covid-19 pandemic

Conditions: Food Literacy; Food Habits; Behavior and Behavior Mechanisms; Eating Behavior

Summary: given that healthy food-related habits are protective of both malnutrition and multiple noncommunicable diseases (including diabetes, heart disease, and cancer), and acknowledging that poor diets constitute a greater risk to mortality, it is essential to improve individuals' food-related knowledge, skills, and behaviours. furthermore, the current public health context caused by the covid-19 pandemic has reinforced the need for an adequate diet as a protective factor for one's global health. in the ambit of the foodlit-pro: food literacy project (ref. sfrh/bd/128528/2017), a digital intervention to promote food literacy - that is, food-related knowledge, competencies, and behaviours - encompassing behavioural change strategies and psychological determinants (such as intention, planning, and self-efficacy) was developed. with the online deliver of personalised evidence-based materials concerning food literacy, adult participants receive weekly challenges that promote their food-related knowledge (e.g., recognising food's origin and seasonality), competencies (e.g., as cooking and planning skills), and behaviours (e.g., tracking food intake, interpret nutritional labels). matched with tailored behavioural change strategies (experimental group), both food literacy content and psychological aspects that relate to health behaviour are assessed weekly in order to evaluate the intervention's efficacy. follow-ups at 3-, 6- and 9-months post intervention will be assessed.


Eligibility criteria:
inclusion criteria: * having a minimum of digital literacy to access, visualise and download online material related to the intervention; * having the availability to participate in the intervention (11 weeks) and posterior follow-up moments.

Keywords: food literacy behaviour change sustainability covid-19
influence of a prematuration culture with a phosphodiesterase-3 inhibitor (pde3-i) on embryonic aneuploidy rate and developmental potential

Conditions: Infertility

Summary: a single centre randomised controlled trial investigating the influence of a novel prematuration system (pms) using a phosphodiesterase-3 inhibitor for in-vitro maturation of oocytes - pilot study.


Eligibility criteria:
inclusion criteria: * healthy volunteers, either with pcos/pcos-like ovaries, or with normal ovaries, who undergo oocyte donation for research * afc at least 10 * amh: \> 5 μg/l * female age \< 36 years exclusion criteria: * major uterine or ovarian abnormalities

Keywords: pcos and normal ovulatory patients aneuploidy in-vitro maturation of oocytes
chronotype-adjusted diet on weight loss

Conditions: Obesity

Summary: background: several reports have observed that the alteration of normal biological rhythms is associated with obesity development. in this regard, those subject with the preference for evening seems to be prone to develop obesity. however, the current treatment of obesity does not take into account these aspects objective: to evaluate whether a diet adjusted to patient's chronotype is more effective than the current dietary recommendations. subjects/methods: 209 subjects take part in a randomized, double-blind clinical trial. 104 subjects followed a typical hypocaloric dietary treatment (control) and the other 105 subjects undergone a diet with a daily caloric distribution adjusted to their chronotype (chrono). conclusions: a chronotype-adjusted diet may be a promising alternative to the classical hypocaloric dietary treatment since the investigator's data indicate a higher effectiveness regarding weight loss when the diet was adjusted to the patient's chronotype.


Eligibility criteria:
inclusion criteria: * students or staff of the catholic university of murcia (ucam), with an age ranged between 18 and 65 years old exclusion criteria: * clinically significant illnesses (including type 2 diabetes, chronic heart failure, hepatitis and cancer) * those taking any medications known to affect body weight (thyroid hormones, corticosteroids, etc.) * women in special physiological situations (pregnant, lactating).

Keywords: obesity appetite regulation chronotype diet
induction and maintenance study of bms-936557 in patients with moderate to severely active crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to determine whether bms-936557 is effective for the treatment of moderate to severely active crohn's disease in patients who have had insufficient response and/or intolerance to conventional therapy for crohn's disease.

anti-ip10: anti interferon-inducible ligand 10

Eligibility criteria:
inclusion criteria: * adults subjects with confirmed crohn's disease (cd) for at least 3 months * moderate to severely active cd as defined by crohn's disease activity index (cdai) 220 to 450 * in the past have had insufficient response and or intolerance to ≥ 1 of the conventional therapy (immunosuppressants, corticosteroids and/or approved biologic therapy) exclusion criteria: * ulcerative colitis (uc) or indeterminate colitis * short bowel syndrome * known stricture or noninflammatory stenosis leading to symptoms of obstruction * current stoma or current need for colostomy or ileostomy
maternal abdominal morphology assessment

Conditions: Pregnancy Related; Infant Development; Pancreas; Diabetes

Summary: previous studies have shown that pancreas size tends to be smaller in individuals with diabetes compared to those without diabetes. the investigators have recently found that pancreas size increases during pregnancy. the mama study aims to examine changes in the pancreas that occur during pregnancy, in both pregnant mothers and their babies, and find out how they are affected by maternal diabetes. the mama study is a prospective cohort study that will follow women and their babies through pregnancy and one year postpartum. women aged 18-54, who are under 14 weeks pregnant are being recruited to participate in the mama study.

as pancreas size is thought to reflect pancreatic insulin production and/or islet mass, monitoring pancreas size during and after pregnancy may advance the investigators' understanding of gestational diabetes mellitus (gdm) incidence and progression. information on pancreas size changes during pregnancy, typical fetal pancreatic development, the relationship between pancreas size and gdm risk, and the relationship between pancreas size and neonatal hypoglycemia are largely unknown. through this project, magnetic resonance imaging (mri) will be used to measure changes in pancreas size during pregnancy and the effect of maternal diabetes on these measures. this prospective cohort study is observational and will include up to 87 pregnant women who are between 18-54 years old. study visits will take place at approximately 15-18 weeks gestation, 24-28 weeks gestation, 34-38 weeks gestation, and 1 year-1 year and 2 months postpartum. at each study visit, participants will self-report their height and weight, have their blood pressure measured, have their blood drawn, have an hba1c finger stick test, participate in oral glucose tolerance testing (ogtt), complete an mri scan, and undergo continuous glucose monitoring (cgm).

Eligibility criteria:
inclusion criteria: * pregnant women, with a singleton gestation * age 18 - 54 years at screening * gestational age \< 14 weeks * willing to commit to 1 year postpartum follow up * planning to remain in geographical vicinity of austin for 1 year after delivery exclusion criteria: * presence of any mechanically or magnetically activated implants * claustrophobia * other contraindication for mri * bmi ≥ 35.0 or maximum width less than 48 cm (necessary to fit within the mri field of view)

Keywords: pregnancy pancreas diabetes
hypertonic saline in posterior spinal fusion

Conditions: Scoliosis Idiopathic; Scoliosis;Congenital

Summary: this is a prospective, randomized study in patients greater than or equal to 10 years of age scheduled for an posterior spinal fusion that requires invasive monitoring of arterial blood pressure. subjects will be randomized to receive either standard of care normosol-r or buffered 2% hypertonic saline for intraoperative fluid resuscitation. the primary objective of this study is to compare intraoperative changes in acid-base status and electrolytes based on the type of fluid administered intraoperatively. the secondary objective is to compare the volume of fluid required and use of adjunctive volume resuscitation with 5% albumin for intraoperative resuscitation when using standard normosol-r or a novel buffered 2% saline solution.


Eligibility criteria:
inclusion criteria: * patients \> or = 10 years of age * asa 1-3 * undergoing a psf procedure requiring two peripheral intravenous infusions and an arterial cannula exclusion criteria: * arterial cannula is not indicated for the surgical procedure * two peripheral intravenous cannulas are not required * an invasive arterial cannula cannot be placed

Keywords: intraoperative fluid resuscitation
investigation of a new medication (gw642444) in asthmatic patients

Conditions: Asthma

Summary: this study will evaluate efficacy (fev1), safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat inhaled doses of gw642444. this will be a multi-centre, double-blind, placebo controlled, dose ascending, four way cross-over study in approximately 28 mild to moderate asthmatic subjects. key assessments: efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics will be assessed by measurement of fev1, blood pressure, heart rate, 12-lead ecgs, clinical laboratory tests, collection of adverse events (ae) information and blood samples.


Eligibility criteria:
inclusion criteria: * female subjects must be non-childbearing (i.e., surgically sterilised or post-menopausal). * non-smokers for at least 6 months. * stable asthma. exclusion criteria: * abnormal findings on heart monitoring assessment. * lower respiratory tract infection within 4 weeks, upper respiratory tract within 2 weeks of study. * currently taking doses of fluticasone propionate over 500mcg/day. * unstable asthma medication.

Keywords: gw642444 asthmatic subjects safety tolerability pd and pk
adjuvant radioimmunotherapy compared with adjuvant chemotherapy for utuc

Conditions: Urothelial Carcinoma

Summary: this study is an ambispective cohort observational study to analyze the efficacy of adjuvant radioimmunotherapy (radiotherapy and immunotherapy) compared with adjuvant chemotherapy in patients with the upper urinary tract urothelial carcinoma with high-risk factors (postoperative pathology suggestive of pt2 and above, n+, g3/high-grade and multiple tumors, positive cut margins). a subgroup analysis was performed to obtain the population of patients who might benefit from different treatment approaches. patients with high risk factors for postoperative recurrence or metastasis will be treated with relevant adjuvant therapy, which in turn will benefit patients.

this study is an ambispective cohort observational study to analyze the efficacy of adjuvant radioimmunotherapy (radiotherapy and immunotherapy) compared with adjuvant chemotherapy in patients with the upper urinary tract urothelial carcinoma with high-risk factors (postoperative pathology suggestive of pt2 and above, n+, g3/high-grade and multiple tumors, positive cut margins). a subgroup analysis was performed to obtain the population of patients who might benefit from different treatment approaches. patients with high risk factors for postoperative recurrence or metastasis will be treated with relevant adjuvant therapy, which in turn will benefit patients.

Eligibility criteria:
inclusion criteria: * confirmed pathologic diagnosis as upper urinary tract urothelial carcinoma(utuc); * high-risk utuc: \>= pt2, pn+, tumor g3 grade, multifocality or positive surgical margins (according to ajcc 8th edition); * aged \>= 18 years old; exclusion criteria: * with distant metastases already found at the time of surgery; non-r0 resected ; * history of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy; * pregnant or lactating women; or women of childbearing potential who are not using reliable contraception; * history of malignant tumors (except skin cancer that is not malignant melanoma and in situ cervical cancer, tumors that have been cured for more than 5 years); * weight loss \> 10% within 6 months; * existing or coexisting bleeding disorders, active infection; * terrible condition cannot tolerate the intervention; * unable to sign informed consent due to psychological, family, social and other factors.

Keywords: upper tract urothelial carcinoma adjuvant therapy adjuvant radiotherapy adjuvant chemotherapy immunotherapy safety analysis progression free survival overall survival
micronutrient and additive modifications may optimize diet to health

Conditions: Ulcerative Colitis; Diet Habit; Microbial Colonization

Summary: this is a prospective clinical intervention trial where patients with moderately active ulcerative colitis are randomized to either normal healthy diet or a diet with elimination of emulsifying agents within the e 400-group with special respect to carragenan, cmc and polysorbates. at study start and end after one month their diet, clinical characteristics and microbiota will be analysed. the hypotheses are that their disease activity measured with calprotectin and their microbiota will improve after intervention.

patients with ulcerative colitis attending the out-patient clinic at skåne university hospital with calprotectin 100-600 will be invited to participate in this diet intervention study. they will be divided into two arms with 35 patients in each, normal diet or e-400 elimination. the diet will be recorded at study start and end with a food diary for four days and a food frequency questionnaire regarding e-400 intake. the patients clinical characteristics (demographics) and disease activity (diarrhoea frequency, blood in stools, abdominal pain, crp and calprotectin) will be recorded and microbiota collectted. the hypotheses are that the activity measured with clinical characteristics and calprotectin as well as their microboita measured with dysbiosis index and total genom with ngs will improve significantly.

Eligibility criteria:
inclusion criteria: * ulcerative colitis, * moderately active * stable medication exclusion criteria: * severe disease * recent surgery * proctitis * pregancy * treatment with antibiotics * difficulties in understanding the information about the study * multimorbidity that makes it impossible to participate

Keywords: ulcerative colitis diet microbiota emulsifying agent
sustained acoustic medicine for osteoarthritis pain

Conditions: Osteoarthritis

Summary: the purpose of this study is to compare sustained acoustic medicine treatment to topical pain relief gel for the symptomatic management of osteoarthritis. the study will measure pain and function scores for patients undergoing treatment.


Eligibility criteria:
inclusion criteria: * have physician-diagnosed mild to moderate knee, shoulder, elbow, ankle, hip, or spine osteoarthritis oa (oarsi atlas grades 1-2) or also referred to as degenerative joint disease (djd). * fulfill the american college of rheumatology clinical and radiological diagnostic criteria for knee oa * are between 35-85 years of age * report a frequent pain score between 3-7 (range: 0-10) during the week preceding enrollment * report that knee, shoulder, elbow, ankle, hip, or spine pain negatively affects quality of life * are willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved treatment provided to the subject at the initiation of the study * are deemed appropriate by their physician or by the study site physician to participate. * be willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study device. * not use or initiate opioid and/or non-opioid analgesic medications. * be willing to discontinue any other interventional treatment modalities on the treatment area during the study period (e.g., transcutaneous electrical nerve stimulation, electronic muscle stimulation, traditional ultrasound). exclusion criteria: * cannot successfully demonstrate the ability to put on and take off the device. * displays any condition which, in the judgment of the investigator, would make participation in the study unacceptable including, but not limited to, the subject's ability to understand and follow instructions. * participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening. * is pregnant. * is a prisoner. * has a pacemaker. * has a malignancy in the treatment area. * has an active infection, open sores, or wounds in the treatment area. * has impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia. * has a known neuropathy (disease of the brain or spinal nerves). * has a hereditary disposition (tendency) for excessive bleeding (hemorrhage). * have knee, shoulder, elbow, ankle, or hip replacement or other surgical intervention, in the affected area in the past 6 months. * requires oxygen support * has an allergy to aspirin or other nsaids * have a secondary cause of arthritis (metabolic or inflammatory)

Keywords: continuous ultrasound sustained acoustic medicine musculoskeletal injuries low intensity continuous ultrasound pain joint injury osteoarthritis
prevalence of a high-intensity signal of the oculomotor nerve on t2 mri sequence in patients with ophthalmoplegia

Conditions: Ophthalmoplegia

Summary: oculomotor nerve (third cranial nerve or iii) palsy is a relatively frequent cause of consultation in ophthalmology. it may reveal a life-threatening pathology such as aneurysm rupture, pituitary apoplexy, and therefore need imaging in emergency. apart from few extreme emergency situations, mri of the oculomotor tract is the first-line examination required. in the usual clinical practice, the investigators noticed in several patients unusual areas of high-intensity signal within the oculomotor nerve on t2 sequence, observed in various locations along the nerve path (cavernous and/ or intra-orbital segment). this abnormal signal, at the best knowledge of the investigators, has never been reported in the literature and could confirm the nerve impairment. in patients with ophthalmoplegia involving probably the third cranial nerve, disclosing this new mri sign could help (i) to confirm the involvement of the oculomotor nerve and eliminate differential diagnoses such as myasthenia (ii) to orientate the etiological diagnosis (inflammatory or ischemic origin). a t2 sequence focused on the iii could thus be systematically included in the usual mri protocol.


Eligibility criteria:
inclusion criteria: * ophthalmoplegia whatever the clinical form (unilateral or not, isolated or not, sudden or progressive onset) exclusion criteria: * absolute contraindication to mri or injection of contrast agents