Kornimate/medical-research-clean huggingface dataset:
the effectiveness of robotic gait training in children with neurological impairment

Conditions: Acquired Brain Injury; Cerebral Palsy

Summary: the recovery of walking ability is one of the primary rehabilitation goals for children with neurological impairment. the aim of the study is to investigate the clinical effectiveness of rehabilitation treatments based of robotic-assisted gait training (ragt). additional goals of the research are to identify the specific effects of ragt in children with different etiologies (acquired brain injury and cerebral palsy) and with different levels of function (according to the gross motor function classification system).


Eligibility criteria:
inclusion criteria: * diagnosis of acquired brain injury in pediatric age and adolescence (4 to 18 years) or cerebral palsy; * femur length of at least 23 cm; * patients able to signal pain, fear or discomfort reliably and to follow simple instructions. exclusion criteria: * injection of botulinum toxin during the 6 months prior to the enrollment; * oral medications reducing muscle tone; * previous orthopedic surgery; * severe lower-extremity contractures; * fractures or osseous instabilities; * osteoporosis; * contraindication of full body load due to previous surgeries; * severe retarded bone growth; * unhealed skin lesions in the lower-extremities; * thromboembolic diseases * cardiovascular instability * acute or progressive neurological disorders * aggressive or self-harming behavior.

Keywords: robotic-assisted gait training gait rehabilitation
effect of plasma sodium concentration on blood pressure regulators during hemodialysis

Conditions: Patients With End Stage Renal Disease on Hemodialysis

Summary: intradialytic hypotension (idh) is a frequent and serious complication that may occur during hemodialysis treatment. the investigators and others have shown that the hemocontrol biofeedback system is associated with improved hemodynamic stability. hemocontrol is a technique that guides the patients' blood volume along a pre-set trajectory by continuously adjusting the ultrafiltration rate and dialysate conductivity. in a recent pilotstudy, the investigators found significantly higher plasma vasopressin levels during the first hour of dialysis with hemocontrol in comparison with standard hemodialysis. increased vasopressin levels may contribute to intradialytic hemodynamic stability during hemodialysis by enhanced vasoconstriction. these results, however, did not prove directly that the improved hemodynamic stability with hemocontrol is indeed caused by higher initial plasma vasopressin levels. alternative explanations might be that 1) the higher initial plasma sodium levels with hemocontrol dialysis enhance activity of the sympathetic nervous system directly, causing vasoconstriction and thereby improved hemodynamic stability and/or 2) that the higher initial plasma levels of sodium in hemocontrol inhibit the release of nitric oxide by the vascular endothelium. another goal of this study is to investigate whether vasopressin is removed with hemodialysis.


Eligibility criteria:
inclusion criteria: * age ≥18 years * a thrice-weekly 4 hours hemodialysis schedule * dialysis on an arteriovenous fistula * a usual interdialytic weight gain of ≥2.0 kg exclusion criteria: * age\<18 years * dialysis duration of \ 4 hours * dialysis frequency of \ 3 times a week * dialysis on a central venous catheter * a usual interdialytic weight gain \<2 kg

Keywords: hemodialysis, sodium, endothelium, sympathetic activity, vasopressin
performance and safety assessment of the mechanical decongestant seawater spray enriched with essential oils from laboratoires gilbert in patient with acute rhinitis associated with nasal obstruction

Conditions: Acute Rhinitis; Nasal Obstruction; Rhinosinusitis; Rhinopharyngitis; Allergic Rhinitis

Summary: the purpose of this post-market clinical investigation is to assess the performance and the safety of the mechanical decongestant seawater spray enriched with essential oils from laboratoires gilbert. the study will evaluate the results of the spray on the acute rhinitis with nasal obstruction over a 7 days period.


Eligibility criteria:
inclusion criteria: * 1. patient ≥ 12 years, * 2. patient with acute rhinitis associated with nasal obstruction during infectious episodes such as rhynopharyngitis (cold), rhinosinusitis, or during non-infectious episodes as allergic rhinitis, * 3. a. informed adult patient who has given written consent prior to any study specific procedure, * b. informed minor patients who has given assent and whose legal guardians have given written consent prior to any study specific procedure, * 4. patient able to meet the study requirements (questionnaire completion), * 5. patient affiliated to a social security scheme. exclusion criteria: * 1. patient who does not want to participate to the clinical investigation, * 2. hypersensitivity to seawater and/or known allergies to any of the ingredients of the spray, * 3. a child with a history of febrile convulsions, * 4. diseases leading to respiratory insufficiency, * 5. patient suffering from nasal deformity or nasal polyps leading to chronic nasal obstruction, * 6. patient on local ans systemic vasoconstrictors, local and systemic corticosteroids and antihistamines, non-steroidal anti-inflammatory (nsaids), antibiotics and local antiseptics, * 7. concomitant use of other nasal sprays, essential oils for local nasal use and nsal cream or gel, * 8. patient under guardianship, curatorship of safeguard of justice.
study of immune globulin intravenous (human) gc5101f in subjects with primary humoral immunodeficiency

Conditions: Primary Immune Deficiency Disorder

Summary: to assess the safety, efficacy, and pharmacokinetics of igiv-sn in pediatric subjects with primary immunodeficiency humoral diseases (phid)


Eligibility criteria:
inclusion criteria: * pediatric subjects with a confirmed clinical diagnosis of a primary humoral immunodeficiency disease as defined by iuis (international union of immunological societies) and require treatment with igiv. documented agammaglobulinemia or hypogammaglobulinemia * subject is willing to comply with all requirements of protocol * authorization to access personal health information exclusion criteria: * subject has secondary immunodeficiency * subject has a history of repeated reactions or hypersensitivity to igiv or other injectable forms of igg * subject has significant protein loss from enteropathy, nephrotic syndrome or lymphangiectasia
clinical pharmacology of aliskiren in combination with cyclosporine in cardiac transplantation

Conditions: Hypertension; Cardiac Transplantation

Summary: the purpose of this study is to evaluate the safety and efficacy of the blood pressure medication, aliskiren, in heart transplant patients. in terms of safety, the investigators will evaluate the blood levels of aliskiren and determine if aliskiren alters the blood levels of the anti-rejection medication, cyclosporine, in these patients. in terms of efficacy, the investigators will determine how well aliskiren lowers blood pressure in heart transplant patients.

hypertension is a major complication following cardiac transplantation, with a prevalence of 93% at 5 years post-transplant. post-cardiac transplant hypertension is due to multiple factors such as use of cyclosporine, chronic kidney disease, and denervation. hypertension in this population is difficult to treat, and most patients require therapy with multiple antihypertensive agents in order to achieve adequate blood pressure control. aliskiren, a direct renin inhibitor, is a novel antihypertensive agent with a unique mechanism of action and potent blood pressure-lowering effects. as such, aliskiren is an attractive treatment option for post-cardiac transplant hypertension. this study will characterize the pharmacokinetic drug-drug interaction profile, pharmacodynamics, and safety of aliskiren 75 mg daily (low-dose) and 150 mg daily, when given in combination with cyclosporine, in cardiac transplant patients.

Eligibility criteria:
inclusion criteria: * 6 months or more since cardiac transplant * clinically stable from a transplant perspective * maintained on a stable immunosuppressant regimen containing cyclosporine + an antiproliferative agent (e.g., azathioprine, mycophenolate), +/- an oral steroid * hypertension, as defined by a seated average systolic blood pressure of ≥ 140 mm hg and a seated average diastolic blood pressure of ≥ 90 mm hg, based on 3 separate measurements, spaced 2 minutes apart. exclusion criteria: * clinical instability from a cardiac transplant perspective * contraindications to aliskiren therapy * conditions that may increase the risk of aliskiren adverse effects * severe hypertension * concomitant medications known to increase or decrease aliskiren plasma exposure.

Keywords: hypertension cardiac transplantation aliskiren cyclosporine
effect of steroids on post-operative complications following proximal hypospadias repair

Conditions: Hypospadias

Summary: the primary objective of this study is to determine the efficacy of administering a course of postoperative oral steroids in pediatric patients undergoing proximal hypospadias repair as prevention against complications. specifically, the study aims to assess if the steroids i) decrease the incidence of wound breakdown, fistula formation, stenosis or stricture formation, and the need for subsequent redo-hypospadias surgeries and/or fistula repairs and ii) improve the quality of wound healing including the overall cosmetic appearance of the phallus (i.e. location of the urethral meatus).

hypospadias repair is a surgery that is, unfortunately, fraught with a high complication rate with problems that include urethrocutaneous fistula formation, complete wound breakdown, glans dehiscence, urethral diverticulum formation, retraction of the urethral meatus, urethral stricture, and meatal stenosis . failure of a proximal hypospadias repair (i.e. the development of a post-operative complication) is unpredictable, and few modifiable risk factors having been identified. complications necessitate subsequent surgical intervention for pediatric patients, which must be carried out under general anesthesia. evidence regarding the harms of multiple general anesthetics for children is increasing. additionally, with each surgical revision comes the morbidity associated with another post-surgical convalescence. thus, any measure that can be gained as a way to increase the rate of success of proximal hypospadias repair would be of help to all pediatric urologists and patients with hypospadias. the proposed intervention of administering a 5 day course of placebo versus oral steroids at a dose equivalent to what is given for outpatient treatment of asthma exacerbations, is expected to have very low risk. this would be the only variation from the current practice and one that has never been studied in the past. thus, it would be worthwhile to perform use scientific methods to determine if the administration of a short course of oral steroids is of benefit to healing and minimization of post-operative complications for hypospadias patients.

Eligibility criteria:
inclusion criteria: * patients undergoing proximal hypospadias repair exclusion criteria: * all patients currently taking steroids at the time of surgery or during the six-week recovery period as well as patients with betamethasone hypersensitivity will be excluded from the study. selection will be based on parent willingness to allow the child to participate in the study.

Keywords: hypospadias
mripositive diagnosis of vestibular neuritis using fluid attenuated inversion recuperation (flair) sequence on a 1.5 tesla

Conditions: Vestibular Neuritis

Summary: our objective is to allow positive mri diagnosis of vestibular neuritis by highlighting contrast enhancement of the vestibular nerve on the pathological side of the flair sequence acquired 1h after intravenous gadolinium injection in patients with typical vestibular neuritis. at present, the diagnosis is based on a combination clinical examination / video-head impulse test, and no imaging examination allows the diagnosis to be positive.


Eligibility criteria:
inclusion criteria: * age 18-80 years * presence of a typical unilateral vestibular neuritis during the ent examination with videonystagmography * subject having his agreement for the use of his medical data for research purposes. exclusion criteria: * special clinical forms of the disease: doubtful or atypical forms, especially the presence of deafness * treatments and related interfering diseases, antecedents: antecedents of neuritis for controls, presence of vertigo, bilateral involvement * impossibility to give the subject information enlightened (subject in emergency situation, difficulties of understanding the subject, ...) * subject under the protection of justice * subject under guardianship or curatorship

Keywords: vestibular neuritis magnetic resonance imaging (mri) vertigo fluid attenuated inversion recuperation (flair)
a comparison study of pf708 and forteo in healthy subjects

Conditions: Osteoporosis

Summary: the purpose of this study is to compare the pharmacokinetics (blood levels) of two teriparatide products, pf708 and forteo, in healthy subjects.

this is a double-masked, randomized, two-treatment cross-over study in healthy adult subjects. half of the subjects will be randomized to receive pf708 first and forteo second (sequence a), and the other half will be randomized to receive the drugs in reverse sequence (sequence b),

Eligibility criteria:
inclusion criteria: * male or female aged 18-50 years at the time of informed consent. * able to understand and sign the written informed consent form (icf). exclusion criteria: * history of or positive test result for human immunodeficiency virus (hiv), hepatitis c virus \[test for hepatitis c virus antibody (hcv ab)\] or hepatitis b virus \[test for hepatitis b surface antigen (hbsag)\]. * female subjects who are pregnant or have a positive pregnancy test result, currently breastfeeding, or planning to become pregnant during the course of the study. * blood donation (greater than or equal to 500 ml) within 30 days prior to screening. * history of paget's disease of bone. * history of prior external beam or implant radiation therapy involving the skeleton. * active urolithiasis or primary hyperparathyroidism. * history of alcohol or substance abuse within 3 years prior to screening. * previous treatment, including for investigational purposes, with any products (e.g., forteo, natpara) derived from human parathyroid hormone (pth).
effect of baduanjin exercise on metabolic syndrome patients

Conditions: Metabolic Syndrome

Summary: pre/posttest randomized control trial design. in this study all patients will be randomly assigned into two groups (30 in each group) : * group a will do baduanjin exercise in addition to traditional medical treatment. * group b will take traditional medical treatment only.


Eligibility criteria:
inclusion criteria: * metabolic syndrome patients exclusion criteria: * patients with respiratory diseases * patients with pacemaker patients * patients with neurological diseases * patients with orthopedic diseases
osa prevalence in atrial fibrillation patients: jordanian study

Conditions: Atrial Fibrillation; Obstructive Sleep Apnea

Summary: current knowledge: countless studies have been conducted to study the relationship between osa and af, and a significant association has been established between both diseases, owing to the numerous shared risk factors and a wide variety of pathophysiological changes resulting from both diseases being relevant to each other. our study inspects this relationship from a cardiovascular standpoint, examining the prevalence of osa in existing af patients, which could be interpreted as af being a risk factor for osa development.


Eligibility criteria:
inclusion criteria: * age 21 or above exclusion criteria: * unable to give research consent * patients who were unwilling to complete the questionnaires * patients who suffer from mental illness

Keywords: af osa berlin questionnaire
digitalization of osteoarthritis care

Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip

Summary: the overall aim of this study is to compare three different care models for patients with hip- and knee osteoarthritis. the primary aim is to evaluate whether an app-based care model is more beneficial for improving function in daily life than a web-based care model and standard care for patients with hip and / or knee osteoarthritis

the primary aim of this study is to evaluate whether an app-based care model is more beneficial for improving function in daily life than a web-based care model and standard care for patients with hip and / or knee osteoarthritis. the secondary aims are to evaluate how 1) patient-related outcome measures regarding the ability of the patient to "forget" about their problematic joint after treatment, quality of life, pain-related self-efficacy, and level of physical activity and 2) care consumption, cost-effectiveness, and carbon footprint differ between the three care models in a short-term (three months) and long-term perspective (one and three years respectively). further aims are to evaluate how patient experience of the benefits provided by the two digital care models differs, how patient experience with respect to work alliance differs between the three care models, describe the adherence to using the app in the app-based care model and to describe what patient characteristics are associated with clinically meaningful improvements in function in daily life among patients recieving app-based care. the primary hypothesis is that patients who are randomized to an app-based care model will improve significantly more in terms of function in daily life from baseline to one year compared with patients who are randomized to a web-based model and usual care. the secondary hypothesis is that patients randomized to the app-based care model change equivalently from baseline to one year in terms of patient-reported measures, but that the app-based care model is more cost-effective compared with the other two care models at one and three years, respectively.

Eligibility criteria:
inclusion criteria: the participant: * has given their written consent to participate in the study * has been referred to the orthopaedic clinic at sahlgrenska university hospital /mölndal for primary hip- and or knee osteoarthritis * has a positive attitude in using digital tools * has access to a smart phone / tablet * has been assessed not to be in need of hip or knee surgery trough triage based on a patient reported outcome (the osteoarthritis guidelines instrument) exclusion criteria: patients: * with secondary osteoarthritis (due to osteonecrosis) * referred to a specific orthopaedic surgeon * with impaired mental ability, reluctance or language difficulties that make it difficult to understand the meaning of participating in the study * who undergo treatment, have disability or illness that according to the research group can affect the treatment or the study result

Keywords: physiotherapy osteoarthritis digital care
satisfaction with xen gel stent versus trabeculectomy for the treatment of glaucoma

Conditions: Glaucoma

Summary: this is a prospective, observational, non-interventional study of patients scheduled to receive surgical intervention either via xen or trabeculectomy for open-angle glaucoma. the decision to treat patients with a particular surgical procedure will not be influenced by the study as the treatment decision will continue to be made by the patient and the clinician. there will be no study mandated visits or treatments.


Eligibility criteria:
inclusion criteria: * diagnosed with oag (open angle glaucoma) and using at least 2 topical iop-lowering medication classes in the study eye * scheduled to receive surgical treatment with either xen (xen gel stent) or trabeculectomy in the study eye * access to an electronic device with internet capabilities and an email address for completion of pros (patient reported outcomes) * be willing and able to complete pros (patient reported outcomes) at the specified time points * able to provide voluntary, informed consent to participate in this study exclusion criteria: * diagnosed with angle closure glaucoma in the study eye * presence of a secondary glaucoma, pseudoexfoliation glaucoma, or pigmentary glaucoma * presence of neovascular, uveitic, or angle recession glaucoma or any glaucoma associate with vascular disorders * prior incisional glaucoma surgery, canal-based surgery, suprachoroidal space-based surgery (trabeculectomy, viscocanalostomy, canaloplasty, shunts of any type, collagen implants, etc.) or a cilio-ablative procedure * clinically significant inflammation or infection in the study eye within 30 days prior to the baseline visit (e.g. blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection) * history of corneal surgery, corneal opacities, or corneal disease * prior intraocular surgery in either eye ≤ 3 months prior to study enrollment with the exception of uncomplicated cataract surgery in either eye ≥ 1 month prior to study enrollment * anticipated ocular surgery in either eye within 6 months of baseline * concomitant cataract surgery scheduled at the time of glaucoma procedure the study eye is defined as the eye receiving surgical intervention with either xen or trabeculectomy. patients who have received prior laser trabeculoplasty will be permitted to participate if all other inclusion/exclusion criteria are met.
clinical evaluation of the nano lv lead system in chronic situation (lenea)

Conditions: LV Lead; LV Therapy; LV Treatment; LV Microcable

Summary: the lenea study is an international, prospective, open label, non-randomized multicenter clinical research study designed to assess the safety and effectiveness of the nano lv lead system.


Eligibility criteria:
inclusion criteria: * approved indication per acc/aha/hrs guidelines for implantation of a crt-d system for treatment of heart failure or life threatening ventricular tachyarrhythmia(s) * receiving a new implant or undergoing an upgrade from an existing icd or pacemaker implant with no prior implanted lv lead or undergoing a new lv implant attempt consecutive to a recent lv lead placement failure not related to coronary sinus cannulation failure * patient receiving the paradym rf crt or paradym rf crt sonr devices * ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations exclusion criteria: * ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment; * incessant ventricular tachyarrhythmias; * unstable angina, or acute mi , cabg , or ptca within the past 4 weeks; * correctable valvular disease that is the primary cause of heart failure; * post heart transplant (patients who are waiting for a heart transplant are allowed in the study); * patient who had previously a permanently implanted lv lead; * concurrent implant with another pacemaker or icd (previously implanted pacemaker or icd devices should be removed prior to implant with the paradym rf crt-d or paradym rf crt sonr); * already included in another clinical study that could confound the results of this study; * life expectancy less than 1 year.