Kornimate/medical-research-clean huggingface dataset:
does sildenafil increase exercise performance in air pollution?

Conditions: Pulmonary Hypertension; Pulmonary Artery Pressure; Exercise Performance; Air Pollution

Summary: the purpose of this study is to examine if the ingestion of a standard dose of sildenafil enhances the athletic performance of competitive athletes when exercising in a high pollutant environment verses a low air pollutant environment.

this study will evaluate effects of sildenafil on exercise performance while breathing high levels of emission exhaust ultrafine and fine particulate matter. exercise performance will be measured by work accumulation (total kj) during a 6-min maximal effort cycle ergometer ride (cer) done immediately after 30 min cycling at 75% of 6 min mean watts determined from familiarization trial. peak oxygen consumption, cardiac output, pulmonary artery pressure, diffusion capacity(dlco), and sao2 will be determined for each trial. blood and urine will be analyzed for sildenafil using lc/ms.

Eligibility criteria:
inclusion criteria: * non-asthmatic * asthmatic * active participants in endurance sports. exclusion criteria: * history of high blood pressure * history of heart disease * pulmonary arterial hypertension * pulmonary emboli * diagnosis of moderate to severe asthma (fev1 \<75% predicted) * pregnant or lactating

Keywords: phosphodiesterase sildenafil pulmonary hypertension exercise performance air pollution
pupillary dilation after incremental tetanic stimulations under ketamine sedation

Conditions: Pain; Anesthesia

Summary: the aim of the study was to describe the relationship between the intensity of a standardized tetanic stimulation and the associated reflex pupillary dilation in patients under ketamine sedation. after an intravenous bolus of 1 mg/kg of ketamine, tetanic stimulations were performed every minute at increasing intensities of 10, 20, 30, 40 and 60 milliamps (similar to the stimulations of neuromuscular blocking agents monitoring). pupillary diameter was measured before and after each stimulation.


Eligibility criteria:
inclusion criteria: * patient admitted to pediatric burns care unit * burnt skin area 5-40% * scheduled for a dressing change under ketamine sedation exclusion criteria: * neurologic or ophthalmic disease
eus-rfa versus surgery for pancreatic insulinoma (erasin-rct)

Conditions: Pancreatic Insulinoma

Summary: the goal of this muticentre randomized controlled trial is to compare endoscopic ultrasound-guided radiofrequency ablation (eus-rfa) with surgery for treatment of pancreatic insulinoma. the main questions it aims to answer are: 1) what is the safest treatment? 2) is efficacy comparable? patients will be randomized to undergo eus-rfa or surgical resection. researchers will compare the rate of adverse events and the clinical efficacy after the two treatments to see if eus-rfa result safer and effective compare with surgery.


Eligibility criteria:
inclusion criteria: * age ≥18 years * diagnosis of pancreatic insulinoma (38) (e.g., fasting test, insulin blood levels, c-peptide blood levels) * presence of a visible single pancreatic nodule on imaging (computed tomography, and/or magnetic resonance imaging, and/or endoscopic ultrasound). * no evidence of distant localizations visualized at computed tomography, and/or magnetic resonance imaging, and/or endoscopic ultrasound * tumor ≤ 2cm * informed consent provided by the patient or closest relative. exclusion criteria: * g2 with ki-67 \>5% on histological examination at eus-guided biopsy samples (if performed) * distance between lesion and main pancreatic duct ≤ 1mm or upstream dilation of the main pancreatic duct * metastatic tumor at the time of diagnosis * multiple pancreatic nodules * diagnosis of multiple endocrine neoplasia type 1 according to guidelines * unfit for surgery or high-risk surgical patients * endoscopic ultrasound not feasible for surgical altered anatomy * known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma * use of anticoagulants that cannot be discontinued * international normalized ratio \>1.5 or platelet count \<50.000 * pregnancy or breast feeding * failure to sign the patient's or closest relative's informed consent
dysport® adult upper limb spasticity extension study

Conditions: Nervous System Disorders

Summary: the purpose of this research study is to assess the long term safety of dysport® in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.

this was a phase iii, multicentre, prospective, open label, repeat treatment cycles, extension to the double study y-52-52120-145 (study 145) . the study included both rollover subjects from study 145 and de novo subjects. the primary study objective was to assess the long term safety of dysport® in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles. the secondary study objective was to assess the long term efficacy of repeated treatment with dysport®.

Eligibility criteria:
inclusion criteria: * completion of the double blind study, y-52-52120-145 exclusion criteria: * major limitation in the passive range of motion in upper limb
early diagnosis of alzheimer-like dementia: benefit of mri and pet imaging

Conditions: Alzheimer Disease; Mild Cognitive Impairment; Vascular Dementia

Summary: the physio-pathology of alzheimer's disease (ad) remains unknown and there is no cure. thus, the search for objective markers of preclinical first signs of cognitive impairment, is currently a major public health issue. early detection of the disease is a major challenge to hope to slow or even stop the neurodegenerative process before the stage of dementia. in ad the investigators observe: * a reduction in the volume of brain hippocampi associated with an alteration of the diffusion of water molecules in the white matter. * a structural brain degeneration coupled with a decrease in cerebral glucose metabolism. recent publications show that cerebrospinal fluid (csf)flow is also altered, probably due to dysfunction of the choroid plexus. hence the potential interest to study is, in addition to conventional imaging, the imaging of csf dynamics and choroid plexus metabolism. in that aim,the investigators use two imaging modalities: * magnetic resonance imaging (mri) is used to assess blood and csf flow in the brain * positron emission tomography (pet) is used to assess glucose metabolism in grey/white matter and also in choroid plexus. the investigators expect that, because of choroid plexus atrophy in ad, csf flow would be altered as well as glucose metabolism dynamic in choroid plexus.


Eligibility criteria:
inclusion criteria: * age: over 65 * participants (or representatives) gave their written informed consent * dementia diagnosed according to diagnostic and statistical manual of mental disorders (dsm iv) criteria * for alzheimer arm: probable alzheimer based disease according to nincds-adrda (national institute of neurological and communicative disorders and stroke and the alzheimer's disease and related disorders association ) criteria * for vascular dementia: diagnosis based on ninds-airen (national institute of neurological disorders and stroke and association internationale pour la recherche et l'enseignement en neurosciences) criteria * for mci: diagnosis based on petersen index exclusion criteria: * claustrophobia * diabetes * cardiovascular disease * glycemia over 1.3 g/l * lumbar puncture within one week before mri examination * non mr-compatible implant * suspected brain metastases * no informed consent signature

Keywords: neurodegenerative disease elderly dementia fdg-pet mri neuroimaging
the physiological effects of pacing on catheter ablation procedures to treat atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this is a two arm randomized, paired prospective study comparing the percentage of time spent above contact force (cf), force time integral (fti) and other lesion parameters in the setting of pacing versus non-pacing. this study is designed to compare the percentage of time spent above cf 10 grams between paced and non-paced lesions at 15 pre-determined lesion locations.

patients will be randomized and proceed to one of two study arms: 1. pacing during first half of lesions: during each of the 15 pre-specified lesions, pacing will be initiated at a 500ms cycle length from a catheter in the coronary sinus or right ventricle prior to the start of the lesion. pacing will be stopped at the halfway point (e.g. after 10 seconds for a 20-second lesion and after 15 seconds for a 30-second lesion). in the event that wenckebach behavior is noted, pacing will be adjusted to a 550ms cycle length. in the event that wenckebach behavior persists, the cycle length will be adjusted to 600ms. in the event that weckebach behavior continues, the pacing catheter will be moved to the right ventricle, which and pacing will be performed at a 500ms cycle length. if wenckebach behavior still persists, the patient will be withdrawn from the study. 2. pacing during second half of lesions: during each of the 15 pre-specified lesions, pacing will be stopped at the halfway point (e.g. after 10 seconds for a 20-second lesion and after 15 seconds for a 30-second lesion). in the event that wenckebach behavior is noted, pacing will be adjusted to a 550ms cycle length. in the event that wenckebach behavior persists, the cycle length will be adjusted to 600ms. in the event that wenckebach behavior persists, the pacing catheter will be moved to the right ventricle and pacing will be performed at a 500ms cycle length. if wenckebach behavior still persists, the patient will be withdrawn from the study.

Eligibility criteria:
inclusion criteria: * patients with af scheduled for af ablation with planned pulmonary vein isolation * presenting in normal sinus rhythm (nsr) prior to lesion delivery exclusion criteria: * previous radiofrequency ablation * previous thoracotomy-type af ablation (maze or similar technique) * in af prior to lesion delivery * evidence of left atrial scarring on voltage map * resting heart rate \> 90 bpm

Keywords: catheter ablation atrial fibrillation
comparison of kinesiology taping and instrument assisted soft tissue mobilization in cervicogenic headache

Conditions: Headache; Cervical Pain

Summary: to compare the effects of kinesiology taping and instrument assisted soft tissue mobilization in cervicogenic headache

cervicogenic headache (cgh) is a clinical syndrome characterized by primarily unilateral pain that originates in the neck, typically provoked by neck movement or pressure over tender points in the neck, with reduced range of movement of the cervical spine . it is characterized by unilateral headache with signs and symptoms of neck involvement, such as, pain by movement, by external pressure over the upper cervical, and/or sustained awkward head positions . functional impairments (diminished strength and endurance) in the cervical muscles and poorer muscle control of the deep cervical flexors have been shown in patients with cervicogenic headache . the international headache society (ihs) has declared cgh as a secondary type of headache.the main cause of cgh is dysfunction in the upper cervical spine, and the mechanism of headache involves nociceptive structures such as the disks, upper cervical spinal nerves, facet joints, ganglia, muscles, and ligaments , pain most commonly arises from the second and third cervical spine (c2/3) facet joints, followed by c5/6 facet joints this sign and symptoms are described as the pain being unilateral or bilateral, affecting the head or face but has most commonly affected the occipital region, frontal region, or retro-orbital region, commonly associated with suboccipital neck pain, but can also be associated with ipsilateral arm discomfort. other symptoms associated with cgh include dizziness, nausea, lightheadedness, inability to concentrate, retro-ocular pain, and visual disturbances.

Eligibility criteria:
inclusion criteria: clinically diagnosed cervicogenic headache patients. * headache with neck stiffness and pain * positive flexion rotation test with restriction 6-10 degree. * unilateral headache with referred pattern * age between 30-44 years * both males and females exclusion criteria: * head and neck surgery * congenital deformity * erosive bone diseases * obese * disc pathologies * malignancy and infection of neck region * osteoarthritis * rheumatoid arthritis * dislocation of vertebraes

Keywords: cervicogenic headache instrument assisted soft tissue mobilization kinesiology taping cervical range of motion neck disability index numeric pain rating scale
a safety and feasibility study of enteral lvt vs. standard of care for seizure control in pediatric cm

Conditions: Seizure; Epilepsy; Cerebral Malaria

Summary: pediatric cerebral malaria (cm) affects more than 3 million children each year killing \~20% and leaving one third of survivors with long term neurologic and psychiatric sequelae. seizures occur commonly with cm and are associated with an increased risk of death and neuropsychiatric disabilities. in this malawi-based, safety and feasibility study of enteral levetiracetam in pediatric cm, the investigators will lay the groundwork for future efficacy studies aimed at improving seizure control and ultimately decreasing the neurologic morbidity of pediatric cm.

cerebral malaria (cm) affects \~3 million children each year, primarily in sub-saharan africa. antimalarial medications can rapidly clear p. falciparum parasites, but mortality rates remain high (12-25%). survivors do not escape unscathed--\~30% experience neurologic sequelae including epilepsy, behavioral disorders and gross neurologic deficits. acute seizures occur commonly in cm and are associated with higher neurologic morbidity and mortality. seizure management in malaria endemic regions is challenging because the available antiepileptic drugs (aed) induce respiratory suppression and assisted ventilation is unavailable. more optimal seizure control may improve neurologic outcomes in pediatric cm survivors, especially if the medication used is affordable and can be delivered safely and easily in resource limited settings. the investigators conducted a dose- escalation study detailed elsewhere (nct01660672) to determine the optimal dose for use in this safety and feasibility study of enteral levetiracetam (lvt) for seizure control in children with cm and seizures admitted to queen elizabeth central hospital in blantyre, malawi. enteral lvt given via nasogastric tube (ngt) rather than an intravenous (iv) formulation will be used since lvt has excellent enteral bioavailability and iv formations are not affordable in most malaria-endemic regions. lvt 40mg/kg followed by 30mg per kg q12 hourly. children admitted with cerebral malaria and seizures will be randomized to lvt vs. standard of care with phenobarbital as needed comparing seizure control, safety, and neurological outcomes.

Eligibility criteria:
inclusion criteria: * comatose with blantyre comas score ≤ 2 * p. falciparum parasitemia via thick blood film or rapid diagnostic test * active seizure in past 24 hours exclusion criteria: * serum creatinine \> 2mg/dl * pre-admission/concomitant treatment with antiretroviral medications for hiv (arvs), antituberculous treatments(atts), or chronic use of any other enzyme-inducing medications
a efficacy and safety study of fostamatinib in the treatment of persistent/chronic immune thrombocytopenic purpura (itp)

Conditions: Immune Thrombocytopenic Purpura

Summary: the purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic immune thrombocytopenic purpura (itp).


Eligibility criteria:
inclusion criteria: * clinical diagnosis of persistent/chronic itp for at least 3 months * average platelet count\ 35,000 unless as a result of rescue therapy) from at least 3 qualifying counts exclusion criteria: * clinical diagnosis of autoimmune hemolytic anemia * uncontrolled or poorly controlled hypertension * history of coagulopathy including prothrombotic conditions
clinical study comparing 7 ends products and 1 combustible cigarette using 2 delivery methods.

Conditions: Nicotine Dependence; Nicotine Dependence, Cigarettes; Tobacco Use; Tobacco Smoking

Summary: a randomized study comparing nicotine pharmacokinetics of seven electronic cigarette products and one traditional cigarette across two delivery (10 puff and ad- libitum) conditions, in healthy adult smokers

e- cigarettes may be an acceptable alternative to traditional cigarette smoking. by utilizing vaporization rather than combustion, the generation and inhalation of hphcs, smoke, and carbon monoxide (co) may be reduced or avoided. this study will provide an understanding of the in vitro levels of nicotine obtained with use of the company's ends products compared to competitor products marketed in the united states of america (usa), and to a popular brand of combustible cigarette smoked in the usa.

Eligibility criteria:
inclusion criteria: 1. male or female aged 18 to 60 years of age inclusive. 2. bmi between 18 to 35 kg / m2 inclusive. 3. healthy based on medical history and screening assessments, in the opinion of the investigator. 4. current smoker of at least 8 cigarettes per day on average. 5. has been smoking for at least 12 months prior to screening. brief periods of non-smoking (e.g., up to \~7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) are permitted at the discretion of the investigator. 6. able to participate, and willing to give written informed consent and comply with study restrictions. exclusion criteria: 1. clinically relevant medical or psychiatric disorder, in the opinion of the investigator. 2. clinically significant abnormality on screening ecg. 3. sustained blood pressure recordings at screening of \ 150 mmhg for systolic blood pressure, or \ 90 mmhg for diastolic blood pressure. 4. sustained resting heart rate of \> 100 or \< 40 beats per minute at screening. 5. positive result for urine drugs of abuse test or alcohol breath test at screening. if a positive urine drug test is observed, and it is believed the positive urine test is due to prescription drugs, the pi should obtain documentation that a) confirms the subject's use of the prescribed medication, and b) the prescribed medication will cause a false positive drug test. 6. clinically significant abnormality in laboratory test results at screening, in the opinion of the investigator. 7. exposure to an investigational drug in a clinical trial within 1 month prior toassessment day 1. 8. blood or plasma donation of \> 500 ml within 1 month prior to assessment day 1. 9. positive urine pregnancy test at screening or assessment day 1 in female subject. 10. any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.

Keywords: electronic nicotine delivery system combustible cigarettes nicotine
self management education asthma

Conditions: Asthma; Lung Diseases

Summary: to evaluate the effects of a new statewide program to enhance identification, referral and provision of care to rural families of hispanic children with moderately severe to severe asthma. specifically, to determine if comprehensive medical care (cmc) plus an educational self-management program for rural hispanic children and their families had an impact on asthma morbidity, as well as on cost and family adaptation.

background: because of new mexico's large rural and heavily hispanic population, it was an ideal setting to determine effective methods for case management, self-management educational programs and effective tertiary to primary care delivery collaboration. the study was part of a demonstration and education initiative "interventions for control of asthma among black and hispanic children" which was released by the nhlbi in june 1989. design narrative: a randomized block design was used with random assignment of subjects by county to treatment groups of 1. comprehensive medical care or standard tertiary care and education, or 2. cmc-plus adding a structured self-management program--open airways/respiro abierto (developed and tested with support of nhlbi). cmc-plus also received in home education and intervention from community based hispanic family educators trained in an empowerment model of family intervention, in-home support, and education. case management was provided by cms; cmc and cmc-plus were provided at the unm-ppp in close collaboration with and transfer of care to the primary physician. additional educational contact with primary care providers and emergency rooms were provided through the unm department of family, community \& emergency medicine which utilized the national institutes of health national asthma education program's guidelines for step-wise care of asthma. asthma morbidity, cost of care, family adaptation and family satisfaction were evaluated using standardized instruments.

Eligibility criteria:
no eligibility criteria
use of probiotics to reduce infections, death and esbl colonisation

Conditions: Neonatal Sepsis

Summary: this study examines the effect of oral probiotic treatment to newborns on preventing hospitalizations, death and colonization with extended-spectrum beta-lactamase-producing gram negative bacteria. half of the babies will receive 4 weeks treatment with an oral mixture of the probiotic labinic (r) while the other half will receive a placebo mixture.

studies show that probiotics given to prematurely born babies prevents sepsis and is widely used in the western world for this purpose. probiotics consists of one or more normal gut-bacteria. a large study in india showed that giving probiotics to full-born babies reduced hospitalizations and morbidity. this study investigates giving a probiotic mixture with different combination of bacteria, lactobacillus acidophilus, bifidobacterium infantis and bifidobacterium breve, for a longer duration (4 weeks instead of 7 days). infections with antibiotic-resistant bacteria is a major threat to health-care world-wide, and sepsis/severe infection caused by such bacteria is a major cause of neonatal death. the study hypothesis is that giving probiotics to newborns prevents them from getting colonized with antibiotic-resistant bacteria, such as extended-spectrum beta-lactamase-producing enterobacteriaceae (esbl-pe). by preventing colonization with esbl-pe, severe infections such as sepsis may be prevented, and thereby survival may be improved.

Eligibility criteria:
inclusion criteria: * healthy newborn infants with a birth weight equal or above 2.0 kgs, will be included in the study between 0-3 days of life. * newborn infants have to come from families who are long-term or permanent residents in the defined catchment area for this trial (30 km radius from hlh) in tanzania. * parents are able and willing to complete study visit (including required study procedures) schedules over the six months proposed follow-up, which also includes hospitalizations required for compliance of this study protocol. * parents agrees for the child not to participate in another study during the study period * children less than one year admitted to hospital with suspected infection, not included in the rct, will be included in a sub-study. a separate inclusion form is prepared for these children. exclusion criteria: * birth weight below 2 kg * other health problems/illness, obvious congenital malformations. * multiple pregnancy * parents not consenting

Keywords: tanzania east africa antimicrobial resistance probiotics extended spectrum beta-lactamase producing bacteria