Kornimate/medical-research-clean huggingface dataset:
tdcs and speech therapy to improve aphasia

Conditions: Aphasia, Global; Stroke; Transcranial Direct Current Stimulation; Speech Therapy

Summary: to study the effect of combined tdcs plus speech therapy compared to sham-tdcs plus speech therapy in subacute stroke patients suffering from moderate or severe aphasia. the patients will be randomized by a computer-generated lot. assessment will be performed at study onset, after six weeks at the end of the specific intervention and 4 months after stroke onset for follow-up.

approximately 25% of all patients after stroke suffer from aphasia. the aphasia could be so severe, that the patient cannot produce any words at all, and so the communication ability is rather poor. in that case speech therapy is the most common therapy, but the functional outcome for the patient is often not sufficiently. the transcranial direct current stimulation (tdcs) might improve the outcome of speech therapy in patients with severe aphasia. the patients will be randomized either to verum stimulation (group a) or sham stimulation (group b). in group a they will receive every workday for 6 weeks 20min of tdcs with 2 ma in combination with a 30 min speech therapy. in group b they will receive every workday for 6 weeks 20min of tdcs with 0 ma in combination with a 30 min speech therapy. the anodal electrode will be placed in case of a total anterior circulation stroke on the homologous speech area on the right hemisphere and in case of a partial anterior circulation stroke perilesional on the left hemisphere. the cathode will be positioned contralateral.

Eligibility criteria:
inclusion criteria: * first time stroke (ischemic or hemorrhagic), either with a total or partial anterior circulation stroke according to the bamford classification * stroke interval 10-45 days * moderate or severe aphasia, i.e. goodglass-kaplan-communication-scale (gks, 0,1 or 2) * native speaker - german * age 18-90 exclusion criteria: * other neurological diseases affecting the cns * known history of epileptic fits, except for an immediate fit * signs in the eeg of increased cortical excitability * patients with hemicraniectomy * fluent aphasia, i.e. gks 3,4 or 5 * speech apraxia * reduced sensibility of the scalp * previously radiated scalp * metallic parts or implants in the brain * participation in other interventional studies
study of cm310 in subjects with seasonal allergic rhinitis

Conditions: Seasonal Allergic Rhinitis

Summary: this study is a multicenter, single arm phase ii clinical study mainly evaluating the efficacy of cm310 in patients with seasonal allergic rhinitis.

allergic rhinitis (ar) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin e (ige) in atopic individuals exposed to allergens.

Eligibility criteria:
inclusion criteria: * male or female aged 18-65. * understand the study and sign the informed consent form voluntarily. * take effective contraception measures throughout the study period. exclusion criteria: * used other investigational drugs. * allergies to drugs with il-4rα monoclonal antibody or drug components of cm310. * plan to participate in other studies during this clinical trial. * with malignant or benign tumors of the nasal cavity. * other reasons the researcher believes that the subject is not suitable to participate in this study.
succinylcholine vs rocuronium for prehospital emergency intubation

Conditions: Coma; Major Trauma; Respiratory Distress; Shock

Summary: all adult patients with spontaneous cardiac activity and requiring tracheal intubation in the pre hospital emergency context will be included in order to compare the use of succinylcholine vs rocuronium for prehospital emergency intubation.

all adult patients with spontaneous cardiac activity and requiring tracheal intubation in the pre hospital emergency context will be included. all intubation will be performed by an emergency physician or a nurse specialized in anesthesia. for patients with spontaneous cardiac activity, rapid sequence intubation will be performed to allow intubation. comparisons studied will be : intubation success rate at the first laryngoscopy, glottis exposure assessed by cormack and lehane classification, difficult intubation rate assessed by the intubation difficult score (ids), the conditions of intubation assessed by the copenhagen score, the need for alternative airway techniques and the immediate post intubation complications rate as vomiting, dental trauma, pulmonary inhalation, arterial desaturation , hypotension episodes and cardiac arrest occurrence.

Eligibility criteria:
inclusion criteria: * all adult patients with spontaneous cardiac activity and requiring tracheal intubation in the pre hospital emergency context exclusion criteria: * patients in cardiac arrest; * patients under-18s; * patients under guardianship ; * pregnancy known; * patients with cons to one of the following three drugs: rocuronium, succinylcholine, sugammadex; * patients not affiliated to a social security scheme (beneficiary or legal).

Keywords: tracheal intubation pre hospital emergency
within subject variability study of er torsemide 20 mg tablet in healthy subjects

Conditions: Congestive Heart Failure; Chronic Kidney Diseases

Summary: the study will evaluate the within-subject variability of 20mg er torsemide as compared to 20mg ir torsemide (demadex) in fully replicate double-crossover trial in healthy volunteers, who are consuming a high-salt diet (300 mmol/day). the study will also evaluate the effects of er torsemide and ir torsemide on 24h sodium excretion and total urinary excretion.

immediate release (ir) torsemide is a highly effective natriuretic drug but its short duration of action is a major drawback, which allows significant post-dose sodium retention, and as consequence, limits salt loss in patients with heart failure, unless dietary salt intake is severely restricted. extended release (er) torsemide is being developed to address the drawback by prolonging the duration of action to increase sodium excretion even in patients who consume high salt diet (300 mmol/day). in addition, ir torsemide induces large and abrupt urination that, in some patients, causes incontinence, and as a result, compliance becomes challenging. er torsemide is formulated to cause robust but gradual urination over an extended period to reduce accidental wetting and improve compliance. in this study, er torsemide is tested for within-subject variability in fully replicate design double-crossover trial in healthy volunteers who are on a 300 mmol/day sodium diet (high salt diet). the primary endpoint of the study is full pharmacokinetics measurements after a single dose of either er torsemide or ir torsemide (demadex). the secondary endpoints are 24h sodium excretion and total urinary excretion.

Eligibility criteria:
inclusion criteria: * healthy male or female, non-smoker, weight 50 kg for male and 45 kg for female, clinically acceptable laboratory profiles with ecg and chest x-ray performed within 6 months exclusion criteria: * participation in bioavailability/bioequivalence studies, * history of drug abuse or alcohol dependence, * history of allergies including drug allergies, * known hypersensitivity to torsemide or related drugs, * presence of clinically significant disorder, * systolic blood pressure \ 140 mm hg diastolic blood pressure, * history of incontinence, * positive urine drug screening etc.
a study of prophylaxis for migraine patients with topiramate in india

Conditions: Migraine

Summary: the purpose of this study is to evaluate the safety and effectiveness of topiramate in preventing migraine among indian participants requiring prophylaxis (measure taken to maintain health and prevent the spread of disease).

this is an open-label (all people know the identity of the intervention), multi-center (study conducted at multiple sites) study. in this study approximately 209 participants will be observed. participants receiving topiramate will be observed monthly for 3 months. safety assessments will include evaluation of adverse events and body weight of the participants which will be monitored throughout the study. the total duration of this study will be approximately 3 months.

Eligibility criteria:
inclusion criteria: * participants who experiencing migraine three or more times per month and require prophylaxis medication * participants having at least 6 months of migraine history (diagnosed as per international headache society criteria with or without aura) * other indications for migraine prophylaxis are: the use of acute treatment medication too frequently (more than 2 treatment days per week); an increasing frequency of headaches that are non-responsive to acute therapy; requiring rescue therapy more than once a month * participants who are seen to benefit from topiramate based upon the physician's judgment exclusion criteria: * headaches other than migraine or episodic tension or sinus headaches or having headaches exceeding 15 days per month * onset of migraine after age 50 * an exclusively migraine aura without headache or a painful condition other than migraine pain * having significant history of unstable medical disease * at risk in terms of the contraindication in the product insert of topiramate

Keywords: migraine indian topiramate
a long term extension study evaluating safety of sildenafil citrate when used to treat pulmonary arterial hypertension (pah) in children

Conditions: Pulmonary Arterial Hypertension

Summary: active treatment, dose-blinded extension study evaluating the safety and long term efficacy of sildenafil citrate in children with pah.


Eligibility criteria:
inclusion criteria: * patients must complete the 16 week double-blind efficacy study a1481131. exclusion criteria: * any patient who did not complete study a1481131.

Keywords: children
cardioneuroablation versus pacemaker implantation for the treatment of symptomatic sinus node dysfunction

Conditions: Sinus Node Dysfunction; Sick Sinus Syndrome

Summary: endocardial ganglion plexus ablation (cardioneuroablation) represents a promising therapeutic technique for the treatment of vasovagal syncope (vv), functional atrioventricular block (avb) and sinus node dysfunction (snd) with a component of vagal hypertonia. nevertheless, there is currently a paucity of literature about the results according to the type of presentation (vv, avb or snd). the investigators aim to assess the safety and efficacy of cardioneuroablation for the treatment of symptomatic snd.

sinus node dysfunction (snd), also known as sick sinus syndrome, comprises a wide spectrum of sinoatrial dysfunctions, ranging from sinus bradycardia, sinoatrial block, and sinus arrest to bradycardia tachycardia syndrome. an additional manifestation of snd is an inadequate chronotropic response to exercise, reported as chronotropic incompetence. since the first cardiac denervation was reported in 2005, several registries and retrospective studies using this therapeutic approach for reflex syncope, snd and functional atrioventricular block have been published. however, due to the lack of randomized studies, current guidelines recommend permanent pacemaker implantation for patients with symptomatic snd in order to improve symptoms. therefore, the purpose of the present study is to assess the safety and efficacy of cardioneuroablation versus permanent pacemaker implantation for the treatment of symptomatic snd. this is a multicenter, randomized, open, interventional study. after being informed of the study and potential risks, participants will undergo a one week screening period to determine eligibility for the study entry. during this week, participants will undergo an exercise test, atropine test, and a 24 hour-holter electrocardiogram. then, participants who meet the eligibility criteria, will be randomized 1:1 to receive permanent pacemaker implantation (control group) or cardioneuroablation (interventional group). the primary endpoint (improve in quality of life assessed with 36-item short form survey (sf-36)) will be evaluated at six months since randomization.

Eligibility criteria:
inclusion criteria: * symptomatic sinus node dysfunction (dizziness, asthenia or syncope) clearly related to an abnormal electrocardiogram finding (sinus arrest, sinoatrial block, extreme bradycardia (\<40 bpm) or chronotropic incompetence in the exercise test). * absence of structural cardiopathy exclusion criteria: * left ventricular ejection fraction \<50% * severe valvular disease * any type of cardiomyopathy such as hypertrophic cardiomyopathy * previous ischemic heart disease * qrs interval \>130 ms * atrioventricular conduction disorder with a former indication of pacemaker implantation (atrioventricular block mobitz ii, advanced atrioventricular block, complete atrioventricular block) * lifetime expectance \<12 months

Keywords: cardioneuroablation
virtual reality activity-based training for preventing falls for older adults with mild cognitive impairment

Conditions: Mild Cognitive Impairment; Fall Prevention; Virtual Reality; Exercise Training

Summary: using a virtual reality (vr) games-based application is as an innovative falls prevention technology in an aged care service. the vr intervention has promising effects on improving the physical and balance performances in the older adults.the study explored and evaluated the effects of vr activity-based training on falls prevention among community-dwelling older adults with mild cognitive impairment.

a pilot randomized control trial study was applied to compare the effects on falls prevention between participants who experienced a full-immersive vr training and group-based exercise (baduanjin) training. eighteen participants were recruited from ausing convenience sampling and were randomly assigned into the vr group and the exercise group (non-vr). the participants in both wo groups' participants attended 16 falls prevention training sessions over eight weeks. eligible participants identified with a higher risk of mild cognitive impairment and early dementia undertook three measurements, pretest (t1), post-test (t2) and follow up (t3). the primary outcomes assessed included changes in physical risks factor of falls, and the secondary outcomes assessed included changes in cognition and fall efficacy.

Eligibility criteria:
inclusion criteria: 1. aged 65 years to 85 years inclusive; 2. had a history of a fall within the past 2 years; 3. community-dwelling older adults; 4. at a higher risk of mild cognitive impairment and dementia, assessed by a validated screening tool of hong kong montreal cognitive assessment test (hk-moca score=21/22); 5. walk independently e.g. able to access publicly - vr research center centre or local community aged care facilities. exclusion criteria: if they had a medical diagnosis of unstable health conditions 1. dizziness; 2. meniere's disease; 3. epilepsy; 4. parkinson's disease; 5. severe hearing impairment and visual impairments; 6. mental illness.

Keywords: fall risk vr mci ageing
study comparing two immunosuppressive regimens in de novo renal allograft recipients

Conditions: Graft Rejection; Kidney Failure; Kidney Transplantation

Summary: evaluate renal graft function (based on the calculated glomerular filtration rate) at 12 months after transplantation in patients receiving either a regimen of sirolimus plus mycophenolate mofetil following an antibody induction (ratg) or a standard regimen combining tacrolimus plus mycophenolate mofetil, both regimens including corticosteroids in patients undergoing renal allograft transplantation. in addition, the two treatment groups will be compared with respect to the incidence of acute rejection at 3, 6 and 12 months following transplantation, and the patient and graft survival at 6 and 12 months after transplantation. the safety of sirolimus plus mycophenolate mofetil following an antibody induction (atg) will be evaluated beginning in the immediate post-operative period.


Eligibility criteria:
inclusion criteria: * age: 18 and \< 65 years * end-stage renal disease, with patients scheduled to receive a primary renal allograft from a cadaveric donor * patients receiving a second transplant without an immunological loss of their first graft in the first six months of transplant exclusion criteria: * evidence of active systemic or localized major infection at the time of initial sirolimus administration * evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening * use of any investigational drug or treatment up to 4 weeks prior to enrollment to the study and during the 12-month treatment phase

Keywords: kidney transplant
effects of two home ergonomics programmes in post-stroke patients

Conditions: Stroke; Quality of Life

Summary: the main objective of the clinical trial is to evaluate the effectiveness of two home ergonomics programmes, by reference to a control group, on functional capacity and quality of life in post-stroke patients.

for post-stroke patients, rehabilitation must address different aspects. when the resulting condition has become established, treatment should take the form of a mixed intervention model, incorporating preventive, rehabilitational and compensatory or adaptive approaches, aimed at enhancing the patient's performance within the environment. physiotherapy and occupational therapy are key disciplines in the composition of multi- and inter-disciplinary teams for the care of stroke patients. in this clinical trial we evaluate the effectiveness of two programmes of ergonomic intervention in the home, with respect to levels of functionality (performance of activities of daily living) and the quality of life of post-stroke patients, by reference to a control group.

Eligibility criteria:
inclusion criteria: * stroke diagnosed 6-24 months previously * aged over 18 years * ability to speak and understand portuguese. exclusion criteria: * severe cognitive deficit * severe aphasia * other associated neurological disease * musculoskeletal pathology * drug or alcohol abuse.
pharmacokinetics study of dapsone-adapalene fixed combination gel in acne

Conditions: Acne Vulgaris

Summary: this study will investigate the pharmacokinetics, safety and tolerability of dapsone and adapalene following topical administration of 2 formulations of dapsone/adapalene fixed combination gel, dapsone 5% gel (aczone®), and adapalene 0.3% gel (differin®) in subjects with acne vulgaris.


Eligibility criteria:
inclusion criteria: * moderate acne on the face * willing to avoid swimming during the study * willing to avoid excessive sunlight and ultraviolet light (e.g., tanning beds)during the study * willing to avoid moisturizers, sunscreens, cosmetics, and chemical peels during the study exclusion criteria: * severe cystic acne * use of topical or oral retinoids within 4 weeks * use of isotretinoin within 3 months * use of dapsone or adapalene within 3 months * anticipated need to engage in activities/exercise that would cause profuse sweating * donated blood or equivalent blood loss within 90 days
increasing cardiac rehabilitation participation among medicaid enrollees

Conditions: Coronary Artery Disease

Summary: participation in outpatient cardiac rehabilitation (cr) decreases morbidity and mortality for patients hospitalized with myocardial infarction, coronary bypass surgery or percutaneous revascularization. unfortunately, only 10-35% of patients for whom cr is indicated choose to participate. medicaid coverage and similar state-supported insurance are robust predictors of cr non-participation. there is growing recognition of the need to increase cr among patients with this form of insurance and other economically disadvantaged patients, but there are no evidence-based interventions available for doing so. in the present study we are examining the efficacy of using financial incentives for increasing cr participation among medicaid patients. financial incentives have been highly effective in altering other health behaviors among disadvantaged populations (e.g., smoking during pregnancy, weight loss). for this study are randomizing 130 cr-eligible medicaid enrollees to a treatment condition where they receive financial incentives contingent on initiation of and continued attendance at cr sessions or to a "usual-care" condition where they will not receive these incentives. treatment conditions will be compared on attendance at cr and end-of-intervention improvements in fitness, decision making and health-related quality of life. cost effectiveness of the treatment conditions will also be examined by comparing the costs of the incentive intervention and usual care conditions with their effects on increasing cr initiation and adherence. should this intervention be efficacious and cost-effective, it has the potential to substantially increase cr participation and significantly improve health outcomes among low-income cardiac patients.


Eligibility criteria:
inclusion criteria: * a recent myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, heart valve replacement or repair, or stable heart failure. * enrolled in a state-supported insurance plan for low income individuals * lives in and plans to remain in the greater burlington, vermont area (chittenden county) for the next 12 mos. exclusion criteria: * dementia (mmse\<20) or current untreated axis 1 psychiatric disorder other than nicotine dependence as determined by medical history * non-english speaking * prior participation in cardiac rehabilitation * advanced cancer, advanced frailty, or other longevity-limiting systemic disease that would preclude cr participation * rest angina or very low threshold angina (\<2 mets) until adequate therapy is instituted * severe life threatening ventricular arrhythmias unless adequately controlled (e.g. intracardiac defibrillator) * class 4 chronic heart failure (symptoms at rest) * exercise-limiting non-cardiac disease such as severe arthritis, past stroke, severe lung disease

Keywords: cardiac rehabilitation contingency management
carbon monoxide migraine-inducing effects in patients with migraine without aura.

Conditions: Headache, Migraine

Summary: to investigate headache score and accompanying symptoms during and after inhalation of carbon monoxide.

to investigate headache score and accompanying symptoms during and after inhalation of carbon monoxide. with transcranial doppler imaging, c-scan and laser speckle the investigators will investigate changes in blood flow velocity of the middle cerebral artery (mca), diameter of the superficial temporal artery (sta), the radial artery and facial skin perfusion.

Eligibility criteria:
inclusion criteria: * healthy volunteers * aged 18-50 * 50-100 kg exclusion criteria: * tension type headache more than once/month * other primary headaches * daily medication except contraceptives * drug taken within 4 times the halflife for the specific drug except contraceptives * pregnant or lactating women * exposure to radiation within the last year * headache within the last 24 hours before start of trial * hypertension * hypotension * respiratory or cardiac disease * smoking * primary relatives with current or previous migraine